COVID-19 Lockdown Exit Analysis

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Nov 2022

New coronavirus at 'particular risk' of jumping to humans discovered in Chinese bats

A new virus with similarities to Coronavirus has been identified in bats with the potential to jump to humans and livestock, according to new research. Chinese and Australian scientists took samples from 149 bats across Yunnan province in China, bordering Laos and Myanmar, and identified five viruses “likely to be pathogenic to humans or livestock”. One virus, known as BtSY2, is closely related to SARS-CoV-2 (which causes Covid-19) and is "at particular risk for emergence." Professor Eddie Holmes, an evolutionary biologist and virologist at the University of Sydney and co-author of the report said: “This means that Sars-Cov-2-like viruses are still circulating in Chinese bats and continue to pose an emergence risk."
27th Nov 2022 - The Mirror

Blood clot drug totally ineffective as post-Covid treatment, research finds

A drug to reduce blood clots, widely prescribed to Covid-19 patients after discharge from hospital, does not lessen their chances of readmission or improve survival, according to groundbreaking research which is set to change treatment protocols around the world. The results of the UK-wide trial, led by Addenbrooke’s Hospital and the University of Cambridge, were shared with the Financial Times. They found that prescribing the anticoagulant Apixaban did not help patients recovering from moderate and severe Covid and in a small number of cases caused serious harm.
27th Nov 2022 - Financial Times

COVID-19 SeroHub, an online repository of SARS-CoV-2 seroprevalence studies in the United States | Scientific Data

Seroprevalence studies provide useful information about the proportion of the population either vaccinated against SARS-CoV-2, previously infected with the virus, or both. Numerous studies have been conducted in the United States, but differ substantially by dates of enrollment, target population, geographic location, age distribution, and assays used. This can make it challenging to identify and synthesize available seroprevalence data by geographic region or to compare infection-induced versus combined infection- and vaccination-induced seroprevalence. To facilitate public access and understanding, the National Institutes of Health and the Centers for Disease Control and Prevention developed the COVID-19 Seroprevalence Studies Hub (COVID-19 SeroHub, https://covid19serohub.nih.gov/), a data repository in which seroprevalence studies are systematically identified, extracted using a standard format, and summarized through an interactive interface.
26th Nov 2022 - Nature.com

Bivalent Covid Boosters Give Some Protection in CDC Study, But Not Much

Covid-19 boosters from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE that fight the latest omicron variants provide only modest short-term protection against mild infections, and experts say it’s still unclear whether the updated shots are any better than earlier versions at preventing hospitalization and severe illness. The bivalent boosters were just 43% effective at preventing mild illness compared to receiving no vaccine in adults 49 and under, according to a US Centers for Disease Control and Prevention study published Tuesday. In those aged 50 to 64 years, comparative protection against symptomatic Covid was 28%, while the booster was just 22% protective in adults 65 and older, the study showed.
25th Nov 2022 - Bloomberg

Is Covid-19 an Endemic Disease and What Does It Mean for the World?

Most of the world is done with Covid-19, though it clearly isn’t done with the world. Countries with the notable exception of China in 2022 unwound a bevy of restrictions designed to contain the coronavirus that causes Covid, and even China loosened its stern rules a bit. For the most part, political leaders and their constituents were eager to pivot to accepting Covid as an endemic disease, much like seasonal flu, even though the World Health Organization continued to designate SARS-CoV-2 a public health emergency of international concern.
22nd Nov 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Nov 2022

View this newsletter in full

COVID-19 vaccine developed in Thailand can be stored in refrigerator for three months

A team of researchers affiliated with several entities in Thailand, working with two colleagues from the U.S. and two from Canada, has developed a mRNA COVID-19 vaccine that can be safely refrigerated for up to three months before use. The team has named it ChulaCov19. In their paper published in the journal Nature Microbiology, the group describes the differences between their vaccine and other mRNA COVID-19 vaccines. Amid the global pandemic, groups around the world have developed vaccines to protect or lessen symptoms of people from/with COVID-19. And of the 172 vaccines developed to date, 40 are RNA-based. The most well-known vaccines have been developed by Pfizer and Moderna, and both have been shown to be effective in preventing serious symptoms.
20th Nov 2022 - Medical Xpress

Over two thirds of first-wave Covid infections led to long Covid, finds study

Over two-thirds of non-hospitalised patients infected with Covid in the first wave of the pandemic developed long Covid, according to a new study. In the first study to directly compare patients who were hospitalised or well enough to remain at home, researchers found fatigue to be the most long-lasting and prevalent symptom. The study of more than 650 patients in Spain found that 59.7% of hospitalised patients and 67.5% of non-hospitalised patients had at least one post-Covid-19 symptom two years later.
20th Nov 2022 - Pulse

Safety of the fourth COVID-19 BNT162b2 mRNA (second booster) vaccine: a prospective and retrospective cohort study

The effectiveness of the second BNT162b2 (Pfizer–BioNTech) mRNA COVID-19 booster vaccine dose (ie, fourth inoculation) is well established, but its safety has yet to be fully understood. The absence of sufficient vaccine safety information is one of the key contributors to vaccine hesitancy. In this study, we aimed to evaluate the safety profile of the second BNT162b2 mRNA COVID-19 booster vaccine using data from a retrospective cohort and a prospective cohort.
20th Nov 2022 - The Lancet

Who Is Dying from COVID Now, and Why

Older people were always especially vulnerable and now make up a higher proportion of COVID fatalities than ever before in the pandemic. While the total number of COVID deaths has fallen, the burden of mortality is shifting even more to people older than age 64. And deaths in nursing homes are ticking back up, even as COVID remains one of the top causes of death for all ages. COVID deaths among people age 65 and older more than doubled between April and July this year, rising by 125 percent, according to a recent analysis from the Kaiser Family Foundation. This trend increased with age: more than a quarter of all COVID fatalities were among those age 85 and older throughout the pandemic, but that share has risen to at least 38 percent since May.
20th Nov 2022 - Scientific American

Covid Drug Treatments Aren't Keeping Up With Virus Mutations

Covid-19’s constant mutations have proven nearly impossible for drugmakers to keep up with. Omicron’s newest stepchildren threaten to render the last two antibody drugs on the market ineffective: Eli Lilly & Co.’s bebtelovimab, which is used to treat symptoms, and AstraZeneca Plc’s Evusheld, which helps prevent infections. When Covid first hit, scientists quickly developed antibody drugs to protect people from the virus’s worst effects. It’s a straightforward premise: a targeted antibody can immediately neutralize a threat inside the body, preventing an infection from even starting.
19th Nov 2022 - Bloomberg

Novavax Nuvaxovid COVID-19 Vaccine Receives Expanded Authorization in Canada as a Booster in Adults

Novavax Inc. today announced that Health Canada has granted expanded authorization for Nuvaxovid™ (COVID-19 Vaccine (Recombinant protein, Adjuvanted)) (NVX-CoV2373) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous booster in adults aged 18 and older. "Canadians now have access to our protein-based Nuvaxovid COVID-19 vaccine as an adult booster," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With the winter months upon us, it's important to have options for vaccination to help protect against COVID-19."
19th Nov 2022 - BioSpace

Job strain and burnout in Spanish nurses during the COVID-19: resilience as a protective factor in a cross-sectional study

Nurses are frequently exposed to chronic stress in the workplace generating harmful effects such as job strain and burnout. On the contrary, resilience has been shown to be a beneficial variable. The objective of this study was to analyze the relationship between dimensions of the Job Demand Control-Support model, resilience and burnout in nurses, and examine the mediating role of resilience between job strain and burnout.
19th Nov 2022 - Human Resources for Health

Stanford researchers launch first study on long-COVID treatment with Pfizer's Paxlovid

Researchers at Stanford University are launching a new study to see whether Pfizer's anti-viral drug Paxlovid, which is approved to treat COVID-19, might also be an effective cure for so-called "long COVID" that causes suffering in patients long after their initial SARS-CoV2 infection. More than 98 million Americans have had COVID-19 since the pandemic began, according to data from the Centers for Disease Control and Prevention. The CDC estimates as many as 1 in 5 adults who have had COVID-19 later experience long COVID symptoms. "Fatigue, cognitive issues, shortness of breath, the list really goes on," said Dr. Linda Geng, who is Co-Director of Stanford's Post-COVID clinic. Dr. Geng says the study is the first in the nation to test Paxlovid on people with long COVID symptoms.
19th Nov 2022 - KTVU FOX 2 San Francisco

‘We’re not ready’: threat of Covid exit wave stymies China’s reopening

China’s doctors have a blunt message for Xi Jinping: the country’s healthcare system is not prepared to deal with a huge nationwide coronavirus outbreak that will inevitably follow any easing of strict measures to contain Covid-19. The warning for China’s leader was delivered by a dozen health professionals — including frontline doctors and nurses and local government health officials — interviewed by the Financial Times this month, and echoed by international experts. “The medical system will probably be paralysed when faced with mass cases,” said one doctor in a public hospital in Wuhan, central China, where the pandemic started nearly three years ago.
19th Nov 2022 - Financial Times

Masks mandated in NSW hospitals as COVID-19 cases rise in Australia's fourth wave

Masks will once again be mandatory in hospitals across New South Wales as the state goes through an increase in COVID-19 cases. Infections and hospitalisations are rising across the country as Australia's fourth wave continues to approach its peak. In New South Wales, confirmed cases rose from 19,800 last week to 27,869 this week, as of 4pm yesterday – a 52 per cent increase – leading to NSW Health mandating masks in hospitals across the state.
19th Nov 2022 - 9News.com

COVID variants BQ.1/BQ.1.1 make up nearly half of U.S. cases - CDC

The U.S. Centers for Disease Control and Prevention estimated on Friday that Omicron subvariants BQ.1 and BQ.1.1 account for nearly half of the COVID-19 cases in the country for the week ending Nov. 19, compared with 39.5% in the previous week. The proportion of the two variants, which are descendants of Omicron's BA.5 sub-variant, have risen to 49.7% of circulating coronavirus variants, around two months after they were initially detected.
18th Nov 2022 - Reuters

Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1

Pfizer Inc and its German partner BioNTech SE said on Friday their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine. Antibody levels against the subvariant rose nearly nine-fold in older adults, aged 55 and above, who received the Omicron shot compared to a roughly two-fold increase in participants with the original shot, according to data posted on online archive bioRxiv.
18th Nov 2022 - Reuters

Hong Kong Eases Covid Restrictions, Only Requires 2 PCR Testing for Arrivals

Hong Kong will cut in half the number of laboratory Covid-19 tests new arrivals must undergo starting next week. Travelers will be swabbed for testing at the airport, and then must arrange one additional nucleic acid test on their second day in the Asian financial hub, Under Secretary for Health Libby Lee said at a briefing on Thursday with reporters. The other two tests currently required, conducted on days four and six, will no longer be needed, she said.
17th Nov 2022 - Bloomberg

Moderna's Omicron shots shows better immune response than original COVID vaccine

Moderna Inc said on Monday its Omicron-tailored vaccines produced a better immune response against the BA.4/5 subvariants in a mid-to-late stage study, when given as a booster dose, compared with its original shot. Data shows that both of Moderna's Omicron-tailored shots, mRNA-1273.214 and mRNA-1273.222, produced a higher antibody response against BA.4/5 subvariants than its original shot in vaccinated and boosted adults, the company said.
15th Nov 2022 - Reuters

China Unveils 20 Measures to Guide Easing of Xi Jinping's Covid Zero Policy

China is relying on 20 key parameters to guide officials on the ground as it eases the contentious Covid Zero policy. Released on Friday, the measures detail what officials should be doing on everything from quarantine to testing, representing a sweeping pullback of the country’s punishing pandemic playbook.
13th Nov 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Nov 2022

View this newsletter in full

COVID-19 and diabetes — where are we now?

At the same time, evidence for a connection of COVID-19 with new-onset T2D appears more robust. Surveys of electronic patient records suggest an overall increased risk of new-onset DM up to 12 weeks post infection3, an increased likelihood of being prescribed insulin within 91 days of COVID-19 diagnosis3 and an excess burden of incident diabetes and hyperglycaemia (where > 77% were stratified as T2D) at 12-month follow up4. If and when glycaemic control is re-established after recovery from COVID-19 in those patients remains unclear. In some cohorts, glucose control had improved in 63–79% of patients 6 months after recovery5,8 and improved in 41–79% of patients 10 months after recovery5,6. Up to 56% of patients remained hyperglycaemic6. A separate cohort of hospitalized COVID-19 patients with dysglycaemia during acute infection displayed reversion to physiological glycaemic control in the post-acute phase in a 7 month follow-up9.
13th Nov 2022 - Nature.com

COVID vaccines: “We flew the aeroplane while we were still building it”

Over the years we had built a strong infrastructure, particularly through the pneumococcal conjugate vaccine programmes. But COVID changed everything in terms of how to approach the end-to-end vaccine R&D concept, driven by the enormous urgency. [In March 2020] when our CEO said, “Get it done before the end of the year,” I said, “This is crazy!” But money was not an issue — and, then, you can do amazing things in an amazing amount of time. We got creative — we couldn’t wait for data, we had to do so much ‘at risk’. We flew the aeroplane while we were still building it.
12th Nov 2022 - Nature.com

Africa CDC Saving Lives and Livelihoods Initiative Expands Implementation in Southern Africa – Africa CDC

The Africa Centres for Disease Control and Prevention (Africa CDC) and Mastercard Foundation today rolled out a large-scale, multi-country COVID-19 vaccination campaign in Southern Africa under the Saving Lives and Livelihoods initiative. The Saving Lives and Livelihood is a $1.5 billion partnership between the Mastercard Foundation and the Africa CDC designed to purchase COVID-19 vaccines for nearly 65 million people, enable vaccine delivery and administration to vaccinate millions more, develop a workforce to support continental vaccine manufacturing, and strengthen the Africa CDC. To date, the Saving Lives and Livelihoods initiative has enabled over 6 million people in Africa to access COVID-19 vaccines, while helping to accelerate vaccine uptake in countries facing the risk of mass vaccine expiration.
12th Nov 2022 - AfricaCDC.org

Africa CDC commends China over partnership in vaccine manufacturing

The Africa Centers for Disease Control and Prevention (Africa CDC) on Friday commended China for partnering with African countries in the manufacturing of COVID-19 vaccines on the continent. Ahmed Ogwell Ouma, the acting director of Africa CDC, said the partnership with countries such as Egypt, Algeria and Morocco has provided the continent with alternative sources of COVID-19 vaccines, particularly at the height of the pandemic in the middle of 2021.
12th Nov 2022 - Xinhua

‘It’s becoming a contortionist’: New COVID-19 subvariants drive wave of infections

A swarm of new subvariants is driving the latest COVID-19 wave in NSW as the virus comes under increasing pressure to find new ways of evading the population’s immunity. One of the new variants – BR.2.1 – has established a base in NSW, with the state home to the vast majority of cases globally. Since the BR.2.1 subvariant was first detected in September, there have been 162 cases detected worldwide, of which 161 were from Australia and 144 were from NSW, the majority of whom had not recently travelled overseas, NSW Chief Health Officer Dr Kerry Chant said. Chant said a mix of subvariants – XBB.1, BQ.1.1 as well as BR.2.1 – were gaining a foothold in the state by evolving in strikingly similar ways that gave them a “competitive advantage” over the COVID-fighting antibodies.
12th Nov 2022 - Sydney Morning Herald

Sanofi, GSK score late win with EU COVID booster approval

Sanofi said on Thursday it won European Union approval for its COVID-19 vaccine booster, jointly made with British partner GSK, after a drawn-out development effort that saw the pair fall behind now-dominant vaccine suppliers. The shot with the brand name VidPrevtyn Beta can be given to people who have already had a primary course of vaccination from other approved shots, the French drugmaker and the European Medicines Agency said in separate statements.
11th Nov 2022 - Reuters

Three quarters of UK long COVID sufferers working less -survey

More than three quarters of British people who have suffered persistent ill health following a COVID-19 infection have had to cut back or change the work they do, according to a survey on the impact of long COVID published on Wednesday. The survey of 1,002 people, conducted by market research company Censuswide in October for recruitment website Indeed, adds to signs that long COVID continues to be a factor behind widespread labour shortages in Britain.
10th Nov 2022 - Reuters

Repeat COVID is riskier than first infection, study finds

The risk of death, hospitalization and serious health issues from COVID-19 jumps significantly with reinfection compared with a first bout with the virus, regardless of vaccination status, a study published on Thursday suggests. "Reinfection with COVID-19 increases the risk of both acute outcomes and long COVID," said Dr. Ziyad Al-Aly of Washington University School of Medicine in St. Louis. "This was evident in unvaccinated, vaccinated and boosted people."
10th Nov 2022 - Reuters

European regulator recommends Pfizer's Omicron booster for children

Pfizer Inc and its partner BioNTech said on Thursday the EU health regulator has recommended authorising the use of their bivalent COVID-19 shot as a booster in children aged 5 through 11. The Omicron-tailored vaccine is already authorised by the European Commission for individuals aged 12 years and above. The updated bivalent booster shot targets the original coronavirus strain as well as the BA.4 and BA.5 sub-variants of Omicron.
10th Nov 2022 - Reuters

Novavax says Omicron shot shows strong immune response as second booster

Vaccine maker Novavax Inc (NVAX.O) said on Tuesday its COVID-19 shot retooled against the Omicron BA.1 variant showed a strong immune response as the fourth dose and met the main goal of strain change in a late-stage study. Data showed the shot, NVX-CoV2515, produced 1.6 times the amount of neutralizing antibodies in people who had previously not been exposed to COVID-19 compared to Novavax's original coronavirus vaccine.
9th Nov 2022 - Reuters

UK approves Pfizer-BioNTech's COVID booster targeting Omicron BA.4/5

Britain's health regulator on Wednesday approved the country's first two-pronged COVID-19 booster targeting the Omicron BA.4 and BA.5 sub-variants and the original coronavirus strain. The Medicines and Healthcare products Regulatory Agency (MHRA) said the vaccine from Pfizer and partner BioNTech was approved for use as a booster in people 12 years and older after it was found to meet safety, quality and effectiveness standards.
9th Nov 2022 - Reuters

Covid's Drag on the Workforce Proves Persistent. 'It Sets Us Back.'

Researchers say the virus is having a persistent effect, keeping millions out of work and reducing the productivity and hours of millions more, disrupting business operations and raising costs. In the average month this year, nearly 630,000 more workers missed at least a week of work because of illness than in the years before the pandemic, according to Labor Department data. That is a reduction in workers equal to about 0.4 percent of the labor force, a significant amount in a tight labor market. That share is up about 0.1 percentage point from the same period last year, the data show. “That may sound tiny, but having that persistent difference over a period of two-and-a-half years is a big deal,” said Jason Faberman, senior economist at the Federal Reserve Bank of Chicago.
7th Nov 2022 - The Wall Street Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Nov 2022

View this newsletter in full

COVID variants BQ.1/BQ.1.1 make up 35% of U.S. cases

The U.S. Centers for Disease Control and Prevention (CDC) on Friday estimated that Omicron subvariants BQ.1 and BQ.1.1 accounted for about 35% of coronavirus cases in the country in the week ending Nov.5 compared with 23.2% in the previous week. The subvariants made up nearly 9% of total cases in the week of Oct. 15 and their proportion has been rising steadily among circulating cases since then. The two variants are descendants of Omicron's BA.5 subvariant and have been spreading rapidly in Europe.
6th Nov 2022 - Reuters

U.S. faces pandemic crossroads with Covid deaths still too high and new omicron variants emerging, Fauci says

White House chief medical advisor Dr. Anthony Fauci on Thursday said the U.S. is at a crossroads in the Covid-19 pandemic as new omicron subvariants are gaining ground across the country. Fauci, in a radio interview Thursday, said the pandemic has clearly eased since last winter, but deaths, which average more than 2,600 per week, remain far too high. At the same time, the new omicron variants are knocking out key tools used to protect the most vulnerable. “We’re really at a point that may be a crossroads here. As we’re entering into the cooler months, we are starting to see the emergence of sublineage variants of omicron,” Fauci said on the “Conversations on Health Care” radio show.
5th Nov 2022 - CNBC

Sweden against giving EU-approved COVID jab to under-30s

The EU-approved COVID-19 vaccine Nuvaxovid should not be administered to people aged 30, and below due to increased health risks posed by it, the Swedish Public Health Agency announced this week. Nuvaxovid was the fifth COVID-19 vaccine to be approved by the EU. After initially approving the vaccine for people aged 18 and over, the Public Health Agency announced on Tuesday that the vaccine presented a danger for people aged 30 and below as it increases the risk of heart muscle inflammation and pericarditis – more commonly known as heart muscle inflammation and pericardial effusion – even though the risk remains “very low”. “We are monitoring the situation closely and awaiting more data. But anyone who is younger and has recently been vaccinated with Nuvaxovid need not be concerned.
5th Nov 2022 - EURACTIV

China Agrees to Approve BioNTech's Covid-19 Vaccine for Foreigners, German Chancellor Says

China agreed to approve BioNTech SE’s Covid-19 vaccines for foreign residents, German Chancellor Olaf Scholz said in Beijing on Friday, in what would mark the first approval of an mRNA vaccine for Covid-19 for use in China. Mr. Scholz and Chinese leader Xi Jinping also discussed a pathway for approving the BioNTech vaccine for the broader population in China, Mr. Scholz said in a news conference, suggesting that regulators at the European Medicines Agency would be involved. “There will be an acceleration of the approval process; that’s been promised to me,” Mr. Scholz told German journalists in a question-and-answer session afterward. He said that Europe would speed up applications made by Chinese companies.
5th Nov 2022 - The Wall Street Journal

Factbox: What are the new BQ.1 and BQ.1.1 coronavirus variants, and why it matters

BQ.1 and BQ.1.1 are among the more than 300 sublineages of the Omicron variant circulating globally, 95% of which are direct descendants of BA.5, according to the World Health Organization. In early July, BA.5 became the dominant subvariant of the coronavirus circulating in the United States, but in October it started giving way to BQ.1 and BQ.1.1. Both contain genetic mutations that make it harder for the immune system to recognize and neutralize the virus. That makes them better at infecting people in spite of immunity from vaccinations and prior infections. Evidence from France, however, where the variants caused a surge in cases, suggests they do not appear to be causing increased rates of hospitalizations and deaths, Dr. Eric Topol, a genomics expert and director of the Scripps Research Translational Institute in La Jolla, California, said on Twitter.
5th Nov 2022 - Reuters

UK researchers cure man with persistent Covid for over a year

Researchers in Britain say they have used genetic sequencing to help cure a man who was infected with the coronavirus for more than 411 days. The 59-year-old patient, who had a weakened immune system due to a kidney transplant and the use of an immunosuppressant drug, initially tested positive in December 2020. After further tests in February 2021 and January 2022 came back positive, the team in London carried out a genetic analysis of the virus, which showed that the same strain was present at each stage, with only minor variations — meaning that the patient was suffering from a chronic coronavirus infection, rather than multiple new infections.
4th Nov 2022 - The Washington Post

Could a nose spray a day keep COVID away?

During the throes of the COVID-19 pandemic, Anne Moscona didn’t feel safe going to a restaurant or catching a flight. And she wished she could feel confident that she could see her immunocompromised relatives without inadvertently spreading the novel coronavirus to them. All this made her work personal: for the past decade, Moscona, a molecular virologist, had been hunting for compounds that could stop viruses in their tracks, before the pathogens infect even a single cell in a person’s body. Now Moscona, at Columbia University in New York City, and her colleagues have homed in on a compound that might foil SARS-CoV-2. Even better, it’s simply sprayed up the nose — no needle required1.
2nd Nov 2022 - Nature.com

'A silent killer' -- COVID-19 shown to trigger inflammation in the brain

Research led by The University of Queensland has found COVID-19 activates the same inflammatory response in the brain as Parkinson's disease. The discovery identified a potential future risk for neurodegenerative conditions in people who've had COVID-19, but also a possible treatment. The UQ team was led by Professor Trent Woodruff and Dr Eduardo Albornoz Balmaceda from UQ's School of Biomedical Sciences, and virologists from the School of Chemistry and Molecular Biosciences. "We studied the effect of the virus on the brain's immune cells, 'microglia' which are the key cells involved in the progression of brain diseases like Parkinson's and Alzheimer's," Professor Woodruff said.
2nd Nov 2022 - Science Daily

Vaxzevria receives full Marketing Authorisation in the EU for the prevention of COVID-19

AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted full Marketing Authorisation (MA) in the European Union (EU). Vaxzevria was originally granted a conditional Marketing Authorisation (cMA) due to the urgency of the COVID-19 pandemic. As there continues to be sufficient evidence of safety and efficacy confirming the benefits of Vaxzevria, the European Medicines Agency (EMA) has now granted a full MA. This decision follows positive recommendation for a full MA by The Committee for Medicinal Products for Human Use (CHMP) of the EMA. The MA covers the use of Vaxzevria in both a primary vaccination series, and as both a heterologous (with an approved mRNA COVID-19 vaccine) or homologous (all the same vaccine) third dose booster. Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “The move from conditional to full marketing authorisation for Vaxzevria is an important confirmation by the EMA of the safety and efficacy of Vaxzevria, demonstrating that the benefits continue to outweigh the potential risks. Vaxzevria is estimated to have helped save over six million lives in the first year of vaccination, which reflects the strength of the evidence showing Vaxzevria’s protection against severe disease and death caused by COVID-19.”
2nd Nov 2022 - AstraZeneca

Everything You Need to Know About the UK's Covid Booster Plan

Britain is in the midst of a fresh Covid-19 booster campaign with 26 million people in England alone being called to receive another dose. The so-called “autumn booster” is being administered at a time when flu cases are rising too and when a number of new omicron variants are circulating that could fuel resurgent waves of Covid infections as winter progresses.
30th Oct 2022 - Bloomberg

China rolls out first inhalable COVID vaccine

In what is believed to be a world first, China's commerical capital of Shanghai this week introduced a new type of COVID-19 vaccine that is inhaled rather than administered via injection. Chinese regulators approved the vaccine, produced by Chinese pharmaceutical firm CanSino Biologics, for use as a booster in September. And now the first people are starting to receive the vaccine, which is inhaled via the mouth from a vessel that looks like a take-out coffee cup with a short mouthpiece.
30th Oct 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 31st Oct 2022

View this newsletter in full

Scientists identify in humans neutralising antibody to Omicron variants

Researchers have identified in humans a pan-variant neutralising antibody, named S2X324, whose neutralizing potency was largely unaffected by any of the Omicron strains of the coronavirus, according to a study. The scientists show that this monoclonal antibody prevents binding to the receptor on host cells that the pandemic coronavirus usually commandeers. They also suggested that combining this antibody with others in a cocktail might reduce the chances of the virus becoming antibody treatment resistant. The international team from University of Washington and Howard Hughes Medical Institute, and Humabs BioMed SA of Vir Biotechnology in Switzerland looked at several aspects of the effects of exposure to earlier forms of the SARS-CoV-2 spike antigen or immune-provoking protein -- on the immune system's reaction to the Omicron variants.
30th Oct 2022 - Business Standard

XBB Symptoms: 10 Nightmare COVID-19 Variant Illness Warning Signs

Dr. Martinello adds that the immune response to a COVID-19 illness is more than just antibodies against SARS-CoV-2 virus. "We also have a cellular response, and it's actually an area of immunology that we're not as easily able to test for, as we are for antibodies," he explains. "We don't know yet how well our cellular immunity is going to be able to respond." Staying up to date on vaccines is crucial at this point, as there is more than enough evidence to suggest that vaccines significantly reduce risk of serious illness, even if they don't always prevent infection
30th Oct 2022 - Good Housekeeping

BQ omicron variant: Will cases spike in the US like they did in Europe?

Why the Europe-to-U.S. trend persists is complex, say experts I spoke with, and they emphasized that there’s no definitive answer. “There are a lot of hypotheses out there that could explain it,” says Lauren Ancel Meyers, director of the COVID-19 Modeling Consortium at the University of Texas in Austin. One major factor is global travel patterns. Europe is a linchpin of global travel, meaning waves that begin elsewhere in the world may tend to be channeled through Europe before reaching the United States. Based on common airline routes, it makes sense that COVID would have initially spread from Asia to Europe first. It also makes sense that delta, which originated in India, would have spread to the UK before reaching the United States, as India and the UK have closer travel ties.
30th Oct 2022 - Slate

EU regulator recommends adding heavy periods to side effects of mRNA COVID shots

A European Medicines Agency (EMA) committee on Friday recommended adding heavy menstrual bleeding to the list of side effect of mRNA COVID-19 vaccines made by Moderna (MRNA.O), as well as Pfizer and its partner BioNTech. Reports of heavy periods - bleeding characterised by increased volume and/or duration that interferes with the quality of life - have been observed during clinical trials, from cases in the real world and in medical literature, the EMA said.
28th Oct 2022 - Reuters

U.S. government to test Pfizer's Paxlovid for long COVID

The U.S. National Institutes of Health's $1 billion RECOVER Initiative has picked Pfizer Inc's antiviral drug Paxlovid as the first treatment it will study in patients with long COVID, organizers of the study said on Thursday. The complex medical condition involves more than 200 symptoms ranging from exhaustion and cognitive impairment to pain, fever and heart palpitations that can last for months and even years following a COVID-19 infection.
28th Oct 2022 - Reuters

Two new Covid strains designated by UK health agency

Two new strains of Covid have been designated, the UK Health and Security Agency (UKHSA) has said. The strains, labelled BQ.1 and XBB, are Omicron variants, have not been designated as variants of concern, meaning they are not thought to be at particular risk of accelerating the spread of the illness. However, studies being conducted at the University of Oxford on behalf of the UKHSA showed "significant reductions" in "neutralisation against several of the newly emergent variants". This could lead to waning immunity among the population, which could in turn "fuel future waves of SARS-CoV-2 infection," the agency said in a statement to ITV News,
28th Oct 2022 - ITV News

People who caught mild Covid had increased risk of blood clots, British study finds

Patients with mild Covid, defined as those not hospitalized, were 2.7 times more likely to develop blood clots, according to the study published in the British Medical Journal on Monday. Patients hospitalized with Covid were 27 times more likely to develop blood clots, 21 times more likely to suffer heart failure and 17 times more likely to have a stroke, according to the study. The risk of cardiovascular disease for mild and severe cases was highest in the first 30 days after infection.
27th Oct 2022 - CNBC

Possible RSV, Covid-19 and Flu Collision Has Doctors Worried. What to Know.

A possible convergence of flu, RSV and Covid-19 has doctors worried. Flu cases are rising earlier than usual, and pediatric hospitals are seeing surges of respiratory syncytial virus, commonly known as RSV. There are also signs that Covid-19 cases are increasing in parts of the country as Americans head into the cooler months. Covid-19 precautions earlier in the pandemic—and their near-disappearance lately—are a big part of the reason flu and RSV are staging a comeback, doctors say. Measures such as masking and social distancing suppressed rates of other viruses, too, leaving those of us who haven’t had a recent infection with lower levels of protection now. “It’s very clear that because people are relaxing Covid precautions that it’s very likely we will also see an increase in influenza at the same time,” says Jay Varma, director of the Cornell Center for Pandemic Prevention and Response in New York City and a physician and epidemiologist at Weill Cornell Medicine. All three viruses share similar symptoms, such as cough, sore throat, runny nose and fever, making it hard to tell what you have without a test. You can test for Covid-19 at home, and most health professionals can test for flu and RSV.
27th Oct 2022 - The Wall Street Journal

Covid’s Heart Effects: Infections Raise Clotting, Death Risks in Large Study

Covid-19 at any level of severity is linked to an increased risk of dangerous blood clots that start in patients’ veins and travel to the heart, lungs and other parts of the body, according to a UK study that highlights the pandemic’s role in driving up rates of cardiovascular disease. Non-hospitalized Covid patients were 2.7 times more likely to develop dangerous clots called venous thromboembolisms and were more than 10 times more likely to die than individuals who avoided the disease, scientists at Queen Mary University of London found in a study of almost 54,000 people followed for an average of about 4 1/2 months. The increase in risk was highest in the first 30 days after the disease began, but could remain elevated even longer, the researchers said.
26th Oct 2022 - Bloomberg

Omicron mutates again: What we know about 3 new subvariants

The omicron variant of COVID-19 has once again evolved, spawning new versions of itself with slight mutations that could make the virus more transmissible or more dangerous. With each new subvariant comes a new mixture of letters and numbers. BA.5 is still the dominant variant in the U.S., according to the latest data from the Centers for Disease Control and Prevention, but two new subvariants are rising up the ranks: BQ.1 and BQ.1.1.
26th Oct 2022 - The Hill

New Covid Boosters Aren't Better Than Old Ones, Study Finds

Bivalent booster shots from Moderna Inc. and Pfizer Inc. failed to raise levels of protective proteins called neutralizing antibodies against the dominant omicron strains any more than four doses of the original Covid vaccine, according to an early independent study on a small group of people. Researchers at Columbia University and the University of Michigan compared levels of neutralizing antibodies in blood samples from 21 people who got a fourth shot of the Moderna or Pfizer-BioNTech SE bivalent boosters against antibody levels in 19 people who got four shots of the original vaccines. Three to five weeks after a fourth shot, those people who received the new boosters aimed at BA.4 and BA.5 variants “had similar neutralizing antibody titers as those receiving a fourth monovalent mRNA vaccine,” the authors conclude in a manuscript posted on the preprint server bioRxiv.org.
26th Oct 2022 - Bloomberg

COVID disrupted measles vaccinations in Africa and now cases are surging

Fall waited with dozens of mothers and babies in the flooded courtyard of Bundung Hospital. Then a doctor emerged with bad news. The hospital had run out of measles vaccines, and it wasn't clear when they would receive more. After what health experts call the biggest backslide in a generation, 26 large or disruptive measles outbreaks have sprung up worldwide, according to the World Health Organization. A devastating outbreak in Zimbabwe has killed more than 700 children this year, chiefly among religious sects that do not believe in vaccinations. Now African health systems remain especially vulnerable due to a lack of funds and manpower, particularly in countries where conflict and malnutrition make children more vulnerable to deadly infection, according to Reuters interviews with more than a dozen disease experts, doctors and global health officials.
24th Oct 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Oct 2022

View this newsletter in full

Doctors say Covid symptom has 'disappeared' from most common list as UK infection rates rise again

According to the Zoe Health Study, the key symptoms to look for now may have changed. While previous data suggested that a fever was a common sign of Covid, it has now dropped out of the top 20 symptoms to look out for, says Professor Tim Spector. "It really is a complete waste of everyone's time to be screening workplaces and care homes... for fever at the moment," he added. However, he did stress that if you have any of the following symptoms, you should get tested and record your result in the ZOE app.
22nd Oct 2022 - Manchester Evening News

WHO official warns COVID-19 pandemic "not yet over"

"The pandemic is not yet over," a World Health Organization (WHO) official warned on Friday, saying the continued emergence of subvariants "poses a risk of resurgence and overwhelming health systems." Babatunde Olowokure, director of Health Security and Emergencies for WHO in the Western Pacific, said Singapore and New Zealand are experiencing surges of COVID-19 cases, while the Philippines, South Korea, Japan, Mongolia, and Vietnam have shown a sustained decline in cases, hospitalization, and deaths since August.
22nd Oct 2022 - Xinhua

Covid-19 Vaccines Should Be Among Regular Immunizations, CDC Advisers Say

Vaccine experts advising the Centers for Disease Control and Prevention supported adding Covid-19 vaccines to the agency’s lists of recommended regular immunizations. The Advisory Committee on Immunization Practices, or ACIP, voted unanimously on Thursday in support of including Covid-19 shots on the lists of measles, tetanus and other inoculations that adults and children 6 months and older should get in the U.S. Now, it is up to the CDC to sign off.
21st Oct 2022 - The Wall Street Journal

U.S. CDC advisers approve adding COVID shots to vaccine schedules

The U.S. Centers for Disease Control and Prevention (CDC) advisory committee on vaccines on Thursday approved adding COVID-19 vaccines to the agency's recommended immunization schedules for both children and adults. The CDC's Advisory Committee on Immunization Practices (ACIP) voted unanimously to add the vaccines to the schedules, which contain recommendations to physicians on which shots their patients should receive and when. Several committee members stressed that they were not setting a requirement for anyone to receive the shots. The CDC has recommended that Americans over 6 months of age should receive a COVID-19 vaccine.
21st Oct 2022 - Reuters

Omicron subvariants reflect a 'viral evolution on steroids'

An omicron subvariant is once again demonstrating immune-dodging abilities, posing a threat to both vaccinated and previously infected individuals. A report published Wednesday in the New England Journal of Medicine suggests that the subvariant, called BA.4.6, could drive reinfections. As of Friday, BA.4.6 accounted for just over 12% of new Covid cases in the U.S. BA.5, meanwhile, has been detected in nearly 68% of new cases, according to the Centers for Disease Control and Prevention.
20th Oct 2022 - NBC News

FDA Authorizes Novavax Covid-19 Shot as Booster for Adults

The Food and Drug Administration granted emergency authorization to Novavax Inc.’s Covid-19 shot as a booster for adults. The shot targets the original strain of the virus, whereas the updated booster shots from Moderna Inc. and Pfizer Inc. and its partner BioNTech SE, authorized in August by the FDA, target both the original strain and newer Omicron strains. The Novavax shot also uses a protein platform, whereas the other two companies’ boosters use messenger RNA, a newer technology. The Novavax booster was authorized on Wednesday for adults who received a primary series of vaccines at least six months prior and who don’t want or can’t access or might have medical reasons to avoid the dual-target booster shots from Pfizer or Moderna.
19th Oct 2022 - The Wall Street Journal

Novavax Covid Booster Wins US Emergency Authorization

Novavax Inc.’s Covid-19 booster for people 18 and older was authorized by US regulators, offering another option to those seeking protection ahead of a potential wave of cases this winter. The booster dose can be administered six months after completion of primary vaccination with an authorized or approved Covid-19 vaccine. Novavax’s booster shot is also available in adults for whom an messenger RNA bivalent shot is not accessible or clinically appropriate.
19th Oct 2022 - Bloomberg

U.S. FDA authorizes Novavax's COVID vaccine as booster for adults

The U.S. Food and Drug Administration on Wednesday authorized Novavax Inc's (NVAX.O) COVID-19 vaccine as a booster for adults, helping the company's shares reverse course and rise more than 3%. The authorization applies for people unable to get updated Omicron-tailored boosters, or those who would choose not to receive any other booster dose. The U.S. Centers for Disease Control and Prevention (CDC) will now have to recommend use of the vaccine as a booster.
19th Oct 2022 - Reuters

U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults

Addiction drug shows promise lifting long COVID brain fog, fatigue

Lauren Nichols, a 34-year-old logistics expert for the U.S. Department of Transportation in Boston, has been suffering from impaired thinking and focus, fatigue, seizures, headache and pain since her COVID-19 infection in the spring of 2020. Last June, her doctor suggested low doses of naltrexone, a generic drug typically used to treat alcohol and opioid addiction. After more than two years of living in "a thick, foggy cloud," she said, "I can actually think clearly."
18th Oct 2022 - Reuters

Pfizer (PFE) Says Omicron Booster Vaccine Lifts Antibodies Against New Variants

Pfizer Inc. and its German vaccine partner said their booster tailored to the latest omicron variants raised more antibodies against the dominant strains of Covid-19 when compared with the original shot designed to fight the form of the virus. Blood from 80 volunteers collected seven days after the booster shot showed an increase in neutralizing antibodies against the BA.4 and BA.5 subvariants in a study, Pfizer and BioNTech SE said in a statement Thursday. The vaccines were authorized without data showing their performance in humans. Pfizer and BioNTech plan to release additional data in coming weeks measuring immune responses one month following administration of the new bivalent booster.
16th Oct 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Oct 2022

View this newsletter in full

Between rolling natural disasters and COVID, Australia's economy is experiencing a shift from shock to persistent problem

Major flooding in suburban areas of Melbourne in the last couple of days have only reinforced the sense that we are now in a world of more or less rolling natural disasters. The times when a massive bushfire or flood event were a shock to the system seem to have well and truly passed. Disaster relief agencies — and even the Australian Defence Forces — are dealing instead with persistent crisis. Last month, the Guardian reported that, in its brief to the incoming government, the Department of Defence had warned it was under intense pressure due to the need to respond to "near persistent" natural disasters, and noted "the impacts of climate change" when requesting more cost-effective ways to manage the continual call-outs.
15th Oct 2022 - ABC News

More information sought on Omicron XBB cases among passengers arriving in Hong Kong from Thailand

Thailand’s Disease Control Department is seeking more information, through International Health Regulations (IHR), about three passengers who arrived in Hong Kong from Thailand infected with a new Omicron sub-variant, known as XBB, according to Dr. Tares Krassanairawiwong, acting director-general of Thailand’s Disease Control Department. He said that 29 XBB cases have been found in Hong Kong, including 24 cases which were detected upon arrival at Hong Kong’s main airport and five who were found two days after their arrival. Most were passengers arriving from Singapore, but three were from Thailand. Dr. Tares said that the department would like to know whether the passengers are residents of Thailand or transit passengers, among other details.
15th Oct 2022 - Thai PBS World

Scientists identify gene that may generate a higher immune response to Covid vaccine

Scientists have identified an immunity gene variant in people with strong responses to Covid-19 vaccines who were less likely to get breakthrough infections, a finding that could improve future shot design. Individuals carrying the specific gene version generated more antibodies against the coronavirus after receiving vaccines from AstraZeneca Plc or the alliance of Pfizer Inc. and BioNTech SE, according to the study published Thursday in the Nature Medicine journal. The same people were less likely than those with different versions of the same gene to get infected with Covid months later, the research found. .
14th Oct 2022 - Bloomberg

Long COVID at 12 months persists at 18 months, study shows

Most patients with COVID-19 who have lingering symptoms at 12 months are likely to still have symptoms at 18 months, new data suggest. The findings are drawn from a large study of 33,281 people in Scotland who tested positive for the coronavirus. Most of the results are in line with those from earlier, smaller studies. Among a subset of 197 survivors of symptomatic SARS-CoV-2 infections who completed surveys at 12 months and 18 months, most reported lingering symptoms at both time points, researchers reported in Nature Communications.
14th Oct 2022 - Reuters

FDA authorizes COVID omicron boosters for kids 5 and up

Moderna’s vaccine was authorized for use at least two months after completion of primary or booster vaccination in children down to six years of age, according to a statement Wednesday from the US Food and Drug Administration. The Pfizer shot can be given at least two months after primary or booster vaccination in children as young as five. While updated booster shots have already been authorized for use in children and adults from the age of 12 and up, uptake of the shots has been slow. Primary vaccinations of children have also gone slowly as parents have seen the risk of infection as low. “Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes Covid-19,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
13th Oct 2022 - Bloomberg L.P. on MSN.com

Scientists Find Gene Variant Tied to Better Covid Shot Response

Pfizer, BioNTech find updated COVID booster protects against Omicron in trial

Pfizer and its German partner BioNTech said their COVID-19 vaccine booster, adapted for the BA.4 and the BA.5 subvariants of Omicron, generated a strong immune response and was well-tolerated in testing on humans. With the results, which the companies described as consistent with preclinical data, the partners are following up with human trial data that had previously been missing from their successful filings for regulatory approval.
13th Oct 2022 - Reuters

Covid-19 Boosters Targeting Omicron Authorized by FDA for Kids as Young as 5

U.S. health regulators on Wednesday expanded eligibility for the new Covid-19 booster shots to children as young as 5 years old, broadening access to help bolster protection against Omicron strains of the coronavirus. The U.S. Food and Drug Administration authorized the updated booster from Pfizer Inc. and its partner BioNTech SE for children ages 5 through 11, and Moderna Inc.’s updated booster for children 6 through 17. Centers for Disease Control and Prevention Director Rochelle Walensky subsequently recommended use of the updated boosters in these age groups. “This is a critical step in our fight against Covid-19. An updated vaccine can help bolster protection for our children this winter,” Dr. Walensky said in a tweet. The FDA in late August cleared the updated Pfizer booster shot for people 12 and older, and Moderna’s for those 18 and older.
12th Oct 2022 - The Wall Street Journal

FDA Authorizes Covid Omicron Boosters for Kids 5 and Up

What are BA.2.75 and BQ 1.1? The two emerging COVID-19 subvariants raising concern among infectious disease experts

Two new subvariants of the Omicron strain of COVID-19 identified in recent months could fuel increased cases and hospitalizations in Canada through the fall and winter, infectious disease experts say. Experts say the variants, labelled BQ.1.1 and BA.2.75, are spreading rapidly in multiple countries. BQ.1.1 is a subvariant of BA.5 and has also been identified in the U.K., where cases have ballooned in recent weeks, while BA.2.75, which the European Centre for Disease Prevention and Control labelled as a variant “of interest” in September, is spreading quickly in India and Singapore.
11th Oct 2022 - CTV News

AstraZeneca Nasal Spray Vaccine for Covid Fizzles in Small, Early Trial

AstraZeneca Plc’s ambitions for developing an easier formulation of its Covid-19 vaccine -- one that might help curb contagion as well -- suffered a setback Monday as the nasal spray failed in an early test. The spray vaccine didn’t elicit a strong immune response in the nasal mucosa tissue or in the rest of the body of volunteers, according to researchers at the University of Oxford. Astra shares fell less than 1% in London.
11th Oct 2022 - Bloomberg

Swiss drugs regulator approves one of Pfizer's COVID-19 booster shots

Swiss drugs regulator Swissmedic said on Monday it had temporarily approved Pfizer's COVID-19 booster shot targeting the original and BA.1 Omicron coronavirus variants. Swissmedic added that the data currently available to it was not yet sufficient to make a decision on Pfizer's bivalent booster vaccine targeting the BA.4 and BA.5 Omicron variants.
10th Oct 2022 - Reuters

From BQ.1.1 to XBB and beyond: How the splintering of Omicron variants could shape Covid's next phase

The United States is in a (relative) Covid-19 lull, with cases and hospitalizations falling as the wave driven by the BA.5 lineage of the Omicron variant recedes. But as if we needed a portent of an anticipated fall and winter wave, Covid is on the rise in some European countries. What’s different, at least for now, is that there’s not one variant pushing the wave. Rather, scientists are tracking a bevy of new forms of Omicron, which are jockeying with each other as they compete to become the next dominant strain. Scientists are monitoring more than 300 sublineages of Omicron, World Health Organization officials said this week. To get a sense of what’s happening right now with the evolution of the SARS-CoV-2 virus, STAT spoke with Tom Peacock, a virologist at Imperial College London.
6th Oct 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Oct 2022

View this newsletter in full

Scrapping Covid rules too early - Australian medical chief

National cabinet has agreed to dump the five-day isolation period for positive cases, with the changes to take effect on October 14. Australian Medical Association president Steve Robson told AAP it was too early to ease the protections. "All the signs are that we're looking at another wave of Covid," he said. "We're coming out of one of the biggest waves of Covid yet and it has absolutely crushed hospital workforce and left us with a massive logjam and backlog in hospitals at the moment that has to be dealt with.
8th Oct 2022 - 1News

COVID wave looms in Europe as booster campaign makes slow start

A new COVID-19 wave appears to be brewing in Europe as cooler weather arrives, with public health experts warning that vaccine fatigue and confusion over types of available vaccines will likely limit booster uptake.
8th Oct 2022 - Reuters

Omicron BA.4.6 subvariant makes up nearly 14% of COVID variants in U.S. - CDC

The U.S. Centers for Disease Control and Prevention (CDC) on Friday estimated that by Oct. 8 nearly 14% of the circulating coronavirus variants in the United States were of the BA.4.6 subvariant of Omicron. In the week ending Oct. 8, the BA.4.6 subvariant is expected to make up 13.6% of total COVID cases in the U.S., higher than the 12.7% prevalence last week. The subvariant has been slowly increasing in prevalence across the U.S., even as the BA.5 subvariant of Omicron remains the dominant strain with 79.2% of the cases.
8th Oct 2022 - Reuters

COVID rebound after Pfizer treatment likely due to robust immune response, study finds

A rebound of COVID-19 symptoms in some patients after taking Pfizer's antiviral Paxlovid may be related to a robust immune response rather than a weak one, U.S. government researchers reported on Thursday. They concluded that taking a longer course of the drug - beyond the recommended five days - was not required to reduce the risk of a recurrence of symptoms as some have suggested, based on an intensive investigation of rebound in eight patients at the National Institutes of Health's Clinical Center.
8th Oct 2022 - Reuters

Europeans face big mental health issues despite COVID easing - survey

The number of Europeans reporting "bad" or "very bad" mental health soared during the COVID-19 pandemic, even beyond the end of lockdowns, new polling showed on Thursday. European Union agency Eurofound's surveys of 200,000 people found that those reporting "bad" or "very bad" mental health doubled from 6.4% in March 2020 at the onset of the crisis to 12.7% two years later even as restrictions were eased.
7th Oct 2022 - Reuters

Seniors died from COVID-19 at a higher rate than any other age group this summer: analysis

More seniors than any other age group died from COVID-19 this past summer amid a disease surge fueled by new subvariants, according to a new analysis published Thursday from the Kaiser Family Foundation. The foundation analyzed COVID-19 data from the Centers for Disease Control and Prevention (CDC) and found that death rates rose much faster for Americans older than 65, despite widespread vaccine coverage within the group. Between April and July 2022, the number of coronavirus-related deaths among seniors grew at a faster rate for older adults, topping 11,000 in July and August. While deaths totals rose for those under 65 as well, the total was about five to six times smaller for younger Americans.
6th Oct 2022 - The Hill

Immune reactions to severe Covid may trigger brain problems, study finds

Severe Covid infections can cause immune reactions that damage nerve cells in the brain, causing memory problems and confusion, and potentially raising the risk of long-term health issues, research suggests. Scientists at King’s College London found that a wayward immune response to the virus increased the death rate of neurons and had a “profound” impact on regeneration in the hippocampus region of the brain, which is crucial for learning and memory. The findings are preliminary but suggest Covid can trigger neurological problems in patients without the virus having to infect the brain itself. The process is believed to underpin delirium in Covid patients, but may also contribute to brain fog and other problems experienced by people with long Covid.
5th Oct 2022 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Oct 2022

View this newsletter in full

Spike-antibody responses to COVID-19 vaccination by demographic and clinical factors in a prospective community cohort study

We evaluate Spike-antibody responses following BNT162b2 or ChAdOx1-S vaccination amongst SARS-CoV2-naive adults across England and Wales enrolled in a prospective cohort study (Virus Watch). Here we show BNT162b2 recipients achieved higher peak antibody levels after two doses; however, both groups experience substantial antibody waning over time. In 8356 individuals submitting a sample ≥28 days after Dose 2, we observe significantly reduced Spike-antibody levels following two doses amongst individuals reporting conditions and therapies that cause immunosuppression. After adjusting for these, several common chronic conditions also appear to attenuate the antibody response. These findings suggest the need to continue prioritising vulnerable groups, who have been vaccinated earliest and have the most attenuated antibody responses, for future boosters.
2nd Oct 2022 - Nature.com

Moderna rejects request from China for Covid-19 vaccine technology

Moderna has reportedly refused a request from China to reveal the technology behind its Covid-19 vaccine. The rejection prompted negotiations for its sale there to fall apart, the Financial Times reported, citing people familiar with the matter. The US pharmaceutical company remains “eager” to sell its product in China after negotiations between 2020 and 2021 dissolved. China has relied on domestically developed vaccines since the beginning of the outbreak in late 2019, and currently procures none of its jabs with foreign companies.
2nd Oct 2022 - City A.M.

Australia scraps mandatory COVID isolation rules - but experts call the decision 'illogical'

Australia is lifting mandatory COVID isolation rules from next month, scrapping one of the last remaining pandemic restrictions. The current five-day home quarantine requirement for those who test positive for the virus will be lifted from 14 October. Announcing the move, Prime Minister Anthony Albanese said: "We want a policy that promotes resilience and capacity-building and reduces a reliance on government intervention." Along with abolishing mandatory quarantine, they will also be scrapping pandemic payments for casual workers with the PM saying it "isn't sustainable for government to pay people's wages forever".
30th Sep 2022 - Sky News

Prominent Chinese commentator urges COVID experts to 'speak out'

Prominent Chinese commentator Hu Xijin said on Sunday that as China ponders its COVID-19 policies, epidemic experts need to speak out and China ought to conduct comprehensive research and make any studies transparent to the public. Hu's unusual call on Chinese social media for candour and transparency earned him 34,000 likes on the popular Twitter-like microblog Weibo, as well as frank responses from netizens in a normally tightly policed internet quick to censor voices deemed a risk to social stability.
30th Sep 2022 - Reuters

AWcorna: China Walvax mRNA Covid Vaccine Gets First Approval, in Indonesia

A Chinese-developed mRNA Covid vaccine got its first ever emergency use authorization from Indonesian authorities, a tentative step in China’s efforts to gain ground on Western inoculations widely used around the world. The shot, named AWcorna, was co-developed by Walvax Biotechnology Co, Suzhou Abogen Biosciences Co. and the Chinese military and has been cleared for use in people aged 18 and older, Walvax said in a statement. The halal-certified vaccine can be used as either a primary or booster dose, it said.
30th Sep 2022 - Bloomberg

Children with COVID-19 more likely to develop type 1 diabetes, study finds

A small team of researchers with members from Case Western Reserve University School of Medicine and the MetroHealth System has found a link between children who contract COVID-19 and an increased risk of developing type 1 diabetes. In their paper published in the journal JAMA Network Open, the group describes their analysis of health records of children and adolescents during the pandemic.
30th Sep 2022 - Medical Xpress

Lingering cardiac involvement in previously well people after mild COVID-19

Serial heart MRI scans conducted in previously well people with mild initial COVID-19 illness suggest that lingering cardiac symptoms may be explained, at least in part, by ongoing mild cardiac inflammation.
30th Sep 2022 - Nature.com

Unlike flu, COVID-19 attacks DNA in the heart: new research

Direct research on the hearts of COVID-19 patients who have died from the disease has revealed they sustained DNA damage in a way completely unlike how influenza affects the body. The finding gives researchers clues about exactly how severe COVID-19 is affecting the body, and also a potential way to detect who will be seriously affected by the disease in the future.
30th Sep 2022 - Brisbane Times

These scientists traced a new coronavirus lineage to one office — through sewage

Virologist Dave O’Connor admits that he was getting desperate when he started asking dog owners for poo samples. For much of 2022, O’Connor, at the University of Wisconsin–Madison, and his colleagues have been tracking a heavily mutated variant of SARS-CoV-2, the virus that causes COVID-19. Early this year, they discovered the variant in Wisconsin waste water drawn from more than 100,000 people. Following the sewer system to ever-smaller watersheds, they narrowed the variant’s source to one particular area. O’Connor and his team thought that the variant might be circulating in dogs, in part because they found canine genetic material in the same wastewater samples. So they headed to the local dog park. “It was the strangest request you’re ever going to hear: ‘Hey, we’re scientists. Can we just have that bag of dog poop that you’re throwing away?’”
30th Sep 2022 - Nature.com

Global Monkey Shortage for Experiments Boosts China’s Vaccine Development

Swedish scientist Karin Lore used to depend on China to keep her laboratory running. A professor at Stockholm’s Karolinska Institutet, Lore studies the immune system’s interaction with vaccines, and safety tests on monkeys are a critical part of her research. But after Covid-19 hit, Beijing halted exports of primates central to her work amid concerns that live animals could contribute to the virus’s spread. More than two years later, monkeys from China are in increasingly short supply, leaving Lore and scientists around the world struggling to complete their research.
30th Sep 2022 - Bloomberg

Myocarditis Risk in Young People Following COVID-19 Infection

Risk of myocarditis is higher following a SARS-CoV-2 infection than it is following a COVID-19 vaccination and increases significantly in men under 40 years, particularly following a second dose of mRNA-1273 vaccine. The risk is still modest following sequential doses or a booster of BNT162b2 mRNA vaccine. These are among the study findings published in Circulation. Researchers sought to evaluate risk for myocarditis in younger people following sequential doses of COVID-19 vaccine vs risks of myocarditis in all individuals who develop SARS-CoV-2 infection.
27th Sep 2022 - The Cardiology Advisor

Pfizer/BioNTech seek FDA nod for new COVID boosters for children

Pfizer Inc and its German partner BioNTech on Monday sought the U.S. Food and Drug Administration's authorization for an Omicron-tailored COVID-19 vaccine booster for children aged 5 through 11 years. The application comes just days after Moderna also applied for FDA authorization of its own Omicron-targeting shot in adolescents aged 12 to 17 years and children aged six to 11.
27th Sep 2022 - Reuters

U.S. FDA clears additional lots of Moderna's Covid booster amid shortage

The U.S. Food and Drug Administration said on Monday it has authorized an additional five batches of Moderna Inc's updated Covid booster shots made at a Catalent facility in Indiana, after it deemed them safe for use. Last week, the health regulator had allowed use of ten batches of Moderna's updated booster shots made at the Bloomington, Indiana facility, owned by a unit of Catalent Inc, which is currently not a part of the company's emergency use authorization.
27th Sep 2022 - Reuters

Valneva in talks with potential partner on second-gen COVID-19 vaccines

French drugmaker Valneva said on Monday it is in talks with a potential partner on producing an updated version of its COVID-19 vaccine that targets new variants of the disease, sending its shares up. The French company has struggled to bring its COVID-19 vaccine to market to compete with rival products from drugmakers such as AstraZeneca, Moderna and BioNTech/Pfizer. Its shares have lost almost 80% since peaking at the end of 2021.
27th Sep 2022 - Reuters

Long COVID Has Forced the U.S. to Take Chronic Fatigue Syndrome Seriously

ME/CFS involves a panoply of debilitating symptoms that affect many organ systems and that get worse with exertion. The Institute of Medicine estimates that it affects 836,000 to 2.5 million people in the U.S. alone, but is so misunderstood and stigmatized that about 90 percent of people who have it have never been diagnosed. At best, most medical professionals know nothing about ME/CFS; at worst, they tell patients that their symptoms are psychosomatic, anxiety-induced, or simply signs of laziness. While ME/CFS patients, their caregivers, and the few doctors who treat them have spent years fighting for medical legitimacy, the coronavirus pandemic has now forced the issue.
26th Sep 2022 - The Atlantic

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Sep 2022

View this newsletter in full

Covid-19: China reopens borders to medical students, but problems remain

Medical students from India who have been studying in China have been heartened by the decision to allow them to return to resume their studies in person, although they admit that many obstacles remain including exorbitant air fares and “zero covid” policies. The Chinese government updated its visa policies for international students on 22 August, allowing them to return. China’s borders were sealed off to international travellers in January 2020, shortly after covid-19 struck. More than 23 000 Indian students and 28 000 Pakistani students are thought to be affected by pandemic quarantines and unable to return to China even after two years. The decision by the Chinese government to start issuing visas to international students comes after months of unrest for Indian medical students in particular.
25th Sep 2022 - The BMJ

Moderna seeks FDA nod for Omicron-targeted COVID shot for adolescents, younger kids

Moderna Inc said on Friday it has requested U.S. authorization for use of its Omicron-targeting COVID vaccine in adolescents and children. The company is seeking emergency use authorization of its updated vaccine in two age groups - adolescents aged 12 to 17 years and children aged six to 11. The application for the bivalent vaccine for children between the ages of six months and under six years is expected to be completed later this year, the company said in a tweet. Earlier this week, the U.S. Centers for Disease Control and Prevention said it expects COVID-19 vaccine boosters targeting circulating variants of the virus to be available for children aged 5-11 years by mid-October.
24th Sep 2022 - Reuters

Covid-like virus lurking in bats deep in Russian caves 'could jump to humans'

A Covid-like virus lurking in Russian bats could jump to humans, scientists warned today. American virologists who carried out experiments on the pathogen — called Khosta-2 — fear it is 'completely resistant' to vaccines deployed during the pandemic. They found it was able to latch onto human cells with ease in the same way as the Covid virus.
23rd Sep 2022 - Daily Mail

COVID raises risk of long-term brain injury, large U.S. study finds

People who had COVID-19 are at higher risk for a host of brain injuries a year later compared with people who were never infected by the coronavirus, a finding that could affect millions of Americans, U.S. researchers reported on Thursday. The year-long study, published in Nature Medicine, assessed brain health across 44 different disorders using medical records without patient identifiers from millions of U.S. veterans. Brain and other neurological disorders occurred in 7% more of those who had been infected with COVID compared with a similar group of veterans who had never been infected. That translates into roughly 6.6 million Americans who had brain impairments linked with their COVID infections, the team said. "The results show the devastating long-term effects of COVID-19," senior author Dr. Ziyad Al-Aly of Washington University School of Medicine said in a statement.
23rd Sep 2022 - Reuters

COVID raises risk of long-term brain injury, large U.S. study finds

The year-long study, published in Nature Medicine, assessed brain health across 44 different disorders using medical records without patient identifiers from millions of U.S. veterans. Brain and other neurological disorders occurred in 7% more of those who had been infected with COVID compared with a similar group of veterans who had never been infected.
23rd Sep 2022 - Bloomberg

U.S. CDC expects Omicron COVID boosters for kids by mid-October

The U.S. Centers for Disease Control and Prevention expects COVID-19 vaccine boosters targeting circulating variants of the virus to be available for children aged 5-11 years by mid-October. The CDC said in a document released on Tuesday that it expects to make a recommendation in early- to mid-October on the use of the new bivalent vaccines in the group, if they are authorized by the U.S. Food and Drug Administration (FDA).
22nd Sep 2022 - Reuters

Asia to Roll Out First Inhaled and Nasal-Spray Covid Vaccines

A new generation of Covid-19 vaccines that can be inhaled or sprayed up the nose—instead of taken by injection—will begin rolling out in Asia, though just how effective they are remains to be seen. Regulators in China and India have greenlighted distribution of vaccines delivered through the mouth or nose, a delivery that scientists say holds the promise of more potent protection against Covid-19 by better reducing infections and preventing the disease’s spread among vaccinated people because they work in the nose and lungs where transmission first happens. Existing vaccines have succeeded in reducing symptomatic disease and severe illness, but have fallen short when it comes to preventing mild infections or transmission.
21st Sep 2022 - The Wall Street Journal

AstraZeneca's Evusheld Gets EU Nod to Help Prevent Severe Covid

The European Union has recommended the use of AstraZeneca Plc’s Evusheld for treating Covid-19, and given the nod to another drug co-developed with Sanofi for preventing respiratory infection from a common virus in young children. Astra’s antibody cocktail Evusheld had already got the green light from authorities across the world to prevent Covid-19 for people with weakened immune systems. Now, it also has a positive recommendation from an expert panel under the European Medicines Agency for the drug to treat adults and adolescents at risk of progressing to severe Covid.
19th Sep 2022 - Bloomberg

Chinese Scientists Develop Mask That Detects Covid, Flu Exposure

Chinese researchers have developed a mask that lets users know if they’ve been exposed to Covid-19 or the flu, a development that could help vulnerable populations even as the use of face coverings falls and more nations ease virus restrictions. A sensor built into a mask was able to detect the Covid-19, H5N1 and H1N1 influenza viruses in the air within 10 minutes and send notifications to a device, according to the study led by six scientists working with Tongji University in Shanghai. The peer-reviewed findings were published in the scientific journal Matter on Monday.
19th Sep 2022 - Bloomberg

Moderna Gives WHO's mRNA Hub Some Help, Pfizer Snubs Request

Moderna Inc. has allowed its Covid-19 vaccine to be used in a World Health Organization effort to develop mRNA shots that would increase production and access for poor countries. Afrigen Biologics & Vaccines, a South African biotechnology company working with the WHO, has used the Moderna vaccine in comparison studies in mice to test the effectiveness of its own shots, said Petro Terblanche, Afrigen’s managing director.
19th Sep 2022 - Bloomberg

Singapore approves Moderna's first bivalent Covid-19 booster jab

The Health Sciences Authority (HSA) on Wednesday granted interim authorisation for the use of Moderna's Spikevax bivalent Covid-19 vaccine, which targets both the original Sars-CoV-2 strain and the Omicron BA.1 variant. The bivalent vaccine has been authorised for use as a booster for people aged 18 and above who have already received their primary series vaccination. HSA did not say when the new vaccine will be made available here. However, in a media release, Moderna said it is working with HSA and the Government to make its bivalent vaccine “available to people in Singapore during September”.
16th Sep 2022 - The Straits Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Sep 2022

View this newsletter in full

Reflecting on the implementation of genomic surveillance for COVID-19 and beyond in the African Region

WHO Regional Office for Africa (AFRO) convened a meeting of COVID-19 epidemiology focal points from ministries of health of selected high-risk countries in Brazzaville (Republic of the Congo) which took place between 10 to 13 August 2022. The aim was to discuss initiatives aimed at improving the quality and effectiveness of COVID-19 surveillance, including genomic surveillance. The Regional Virologist at WHO AFRO set the scene: "Currently, 40 out of the 47 Member States (85%) in the African Region have in-country capabilities for genomic sequencing and 46 Member States (98%) are sharing their genetic sequence data through a publicly accessible database. The Region has established a coordinated mechanism to sustain and strengthen these gains and has set up three centres of excellence for genomic surveillance, developed standardized guidance documents, offered capacity building for Ministries of Health’s personnel and set up laboratory infrastructure for routine pathogen genomic surveillance, including wastewater surveillance."
18th Sep 2022 - World Health Organization

Step up hunt for origins of Covid-19, Lancet panel urges

An international expert panel on Covid-19 has called for continued investigation into the origins of the coronavirus, saying the pathogen could have either spilled over from nature or an infection of a laboratory worker. In its final report this week, the Lancet Commission on Covid-19 led by Columbia University professor Jeffrey Sachs said the virus could well have had a natural origin, but the commission could not rule out it could have passed to humans during laboratory research in Wuhan, the Chinese city where the virus was first detected, or elsewhere. Even if it was a laboratory leak, it could well be a natural virus or a bioengineered virus, the report said, adding investigation and better monitoring of such research was needed.
18th Sep 2022 - South China Morning Post

GSK, Regeneron Covid Antibody Drugs Unlikely to Work for Omicron, WHO Says

The antibody drugs GSK Plc and Regeneron Pharmaceuticals Inc. developed against Covid don’t appear to work for omicron and its subvariants, a panel of experts advising the World Health Organization said, recommending against the use of the medicines. The group’s decision comes amid “evidence from laboratory studies that these drugs are not likely to work against currently circulating variants,” the panel said in the medical journal BMJ Friday.
18th Sep 2022 - Bloomberg

WHO 'strongly advises against' use of two COVID treatments

Two COVID-19 antibody therapies are no longer recommended by the World Health Organization (WHO), on the basis that Omicron and the variant's latest offshoots have likely rendered them obsolete. The two therapies - which are designed to work by binding to the spike protein of SARS-CoV-2 to neutralise the virus' ability to infect cells - were some of the first medicines developed early in the pandemic. The virus has since evolved, and mounting evidence from lab tests suggests the two therapies - sotrovimab as well as casirivimab-imdevimab - have limited clinical activity against the latest iterations of the virus. As a result, they have also fallen out of favour with the U.S. health regulator. On Thursday, WHO experts said they strongly advised against the use of the two therapies in patients with COVID-19, reversing previous conditional recommendations endorsing them, as part of a suite of recommendations published in the British Medical Journal.
17th Sep 2022 - Reuters

EU regulator backs wider use of AstraZeneca COVID therapy

Europe's medicines regulator has backed using AstraZeneca's preventative COVID-19 therapy as a treatment for the disease and also endorsed another medicine as preventative option for another common virus. The regulator's recommendations are usually followed by the European Commission when it takes a final decision on drug approvals. AstraZeneca said on Friday the European Medicines Agency (EMA) had backed Evusheld as a treatment for adults and adolescents with COVID who do not need supplemental oxygen and who are at increased risk of their disease worsening.
17th Sep 2022 - Reuters

'Eighth wave of Covid imminent in France' says health ministry

Covid appears to be making a comeback in France, after cases jumped by 55.5% over the past seven days, and 41,850 cases were reported in the last 24 hours. The figures from the Health Ministry and health authority Santé publique France, released on September 13, show a significant rise in infections. The daily average over the past seven days is around 17,000, but rising. The Health Ministry has warned that “an eighth wave” appears to be imminent and Health Minister François Braun has called on people in France to take “responsibility” and think about bringing back their social distancing and hygiene measures where appropriate.
16th Sep 2022 - The Connexion France

Singapore grants interim authorisation for first bivalent COVID-19 booster vaccine

The Health Sciences Authority (HSA) on Wednesday (Sep 14) granted interim authorisation for the first bivalent COVID-19 booster vaccine in the country. The Spikevax Bivalent Original/Omicron COVID-19 jab by Moderna comprises two components that target the original SARS-CoV-2 strain and the Omicron BA.1 variant respectively.
16th Sep 2022 - CNA

Moderna open to supplying COVID vaccines to China, CEO says

Moderna Inc has held talks with the Chinese government about supplying COVID-19 vaccines, but no decision has yet been made, CEO Stephane Bancel told Reuters on Wednesday. As the rest of the world gradually lifts COVID restrictions, China continues to lock down enormous parts of society and conduct mass testing to eradicate the coronavirus. It has not approved any foreign COVID vaccines and relies on several domestically developed shots.
16th Sep 2022 - Reuters

New bivalent COVID-19 booster vaccine doses expected to be available in Singapore by end-Sep: Moderna

Moderna’s new bivalent COVID-19 booster vaccine is expected to be available in Singapore by end of this month. “We hope to have hundreds of thousands of doses available in Singapore before the end of the month,” the pharmaceutical firm’s senior vice president of commercial vaccines Patrick Bergstedt told CNA on Wednesday (Sep 14). His comments came after the Health Sciences Authority (HSA) announced that it granted interim authorisation for Moderna’s Spikevax Bivalent Original/Omicron jab, the first bivalent COVID-19 booster vaccine in the country. Official vaccination recommendations using this booster will be issued by the Expert Committee on COVID-19 Vaccination and the Ministry of Health (MOH) in due time, HSA said.
15th Sep 2022 - CNA

Another new COVID variant is spreading – here's what we know about omicron BA.4.6

BA.4.6, a subvariant of the omicron COVID variant which has been quickly gaining traction in the US, is now confirmed to be spreading in the UK. The latest briefing document on COVID variants from the UK Health Security Agency (UKHSA) noted that during the week beginning August 14, BA.4.6 accounted for 3.3% of samples in the UK. It has since grown to make up around 9% of sequenced cases. Similarly, according to the Centers for Disease Control and Prevention, BA.4.6 now accounts for more than 9% of recent cases across the US. The variant has also been identified in several other countries around the world.
14th Sep 2022 - The Conversation Indonesia

Japan Approves Pfizer and Moderna’s Omicron Boosters for Use

Pfizer Inc. and Moderna Inc.’s Covid-19 vaccines targeting the omicron variant were approved by Japan’s health ministry late Monday, paving the way for them to be rolled out in the world’s third-largest health-care market. The ministry endorsed the shots shortly after an expert panel advised deploying the boosters. Pfizer’s omicron booster can be administered to Japanese aged 12 and over, the panel advised, while Moderna’s should be limited to those 18 and above.
13th Sep 2022 - Reuters

Covid-19 fast becoming endemic in Thailand, says top virologist

He added that he expects Covid-19 cases to start dropping from late September to mid-December but start spreading again in the cool season from late December to early March and then again the in the rainy season. He pointed out that most people in Thailand catch flu and other respiratory viruses during the rainy season. “However, Covid-19 infections are currently on a downward trajectory,” he said, adding that public health agencies should launch vaccination drives for Covid-19 and other viruses before the start of the rainy season every year.
4th Sep 2022 - Nation Thailand

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Sep 2022

View this newsletter in full

New Covid wave in autumn 'virtually certain' say French experts

Immunologist Brigitte Autran, president of new government health advisory body the Comité de veille et d’anticipation des risques sanitaires (Committee to monitor and anticipate health risks) which has replaced the Conseil scientifique, told Le Parisien that “the Covid epidemic is not behind us” and said that the French would have to get used to “living with” the virus. The Covidtracker website currently shows that the virus is in decline across France, with the R-rate currently at 0.7 – any figure lower than one indicates that the number of infections is falling.
10th Sep 2022 - The Local France

Scientists Found a New Antibody That Neutralizes All COVID Variants

COVID-19 vaccines have been effective at keeping people from getting severely ill and dying from the virus, but they’ve required different boosters to try to keep on top of all of the coronavirus variants that have popped up. Now, researchers have discovered an antibody that neutralizes all known COVID-19 variants. The antibody, called SP1-77, is the result of a collaborative effort from researchers at Boston Children’s Hospital and Duke University. Results from mouse studies they’ve conducted were recently published in the journal Science Immunology, and they look promising.
9th Sep 2022 - Prevention Magazine

SINOVAC Approved to Initiate Clinical Trial for Its Omicron Containing COVID-19 Vaccine in Chile

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that the Chilean Public Health Institute (Instituto de Salud Pública, ISP) approved a phase II clinical trial for its inactivated Omicron strain COVID-19 vaccine and trivalent COVID-19 vaccine (ancestral, Delta and Omicron variants) on August 31st. The clinical trial will evaluate the immunogenicity and safety of one booster dose of the two candidate vaccines in adults who had received two booster doses of CoronaVac®, mRNA, or adenovirus vector COVID-19 vaccine. This study is the world's first study researching multivalent inactivated COVID-19 vaccine.
8th Sep 2022 - Business Wire

Long COVID's link to suicide: scientists warn of hidden crisis

The 56-year-old, who caught the disease in spring 2020, still had not recovered about 18 months later when he killed himself at his home near Dallas, having lost his health, memory and money. "No one cares. No one wants to take the time to listen," Taylor wrote in a final text to a friend, speaking of the plight of millions of sufferers of long COVID, a disabling condition that can last for months and years after the initial infection.
8th Sep 2022 - Reuters

US Orders 100 Million COVID Tests, White House Says More Needed

The United States will boost its stockpile of at-home COVID-19 tests, ordering more than 100 million tests from domestic manufacturers, the White House said on Thursday, but warned it was a short-term solution. President Joe Biden's administration has repeatedly and unsuccessfully asked Congress for more pandemic money. It said last week it would request $22.4 billion in emergency funding for COVID-19 relief ahead of a potential case surge in autumn. "The administration is acting, within its limited funding, to increase the supply of at-home COVID-19 tests in the Strategic National Stockpile (SNS) by purchasing over 100 million additional at-home, rapid tests from domestic manufacturers," the White House said in a statement.
8th Sep 2022 - VOA News

Pandemic Readiness Lobby Draws In Biotech, Government Members

Drug and biotechnology firms, academics, investors and former government officials are launching a new lobbying group that hopes to improve long-term support for technology and products to combat future pandemics and other biological threats. Initial members of the group include Roche Holding AG’s Genentech unit, Flagship Pioneering Inc., Ginkgo Bioworks Holdings Inc., Siga Technologies Inc., Coherus Biosciences Inc., ImmunityBio Inc., IGM Biosciences Inc., Texas A&M University and the University of Nebraska Medical Center. The group, which will be called the Medical Countermeasures Coalition, or MC2, says it hopes to create sustained investment and a better market for pandemic preparations, which have often fallen victim to what is known as the cycle of “panic and neglect” following emergencies
7th Sep 2022 - Bloomberg

How Pfizer and BioNTech Modified Covid-19 Vaccines for Fall Boosters

Before new versions of the Omicron strain took hold in the U.S., Pfizer Inc. and BioNTech SE had begun tinkering with their widely used Covid-19 vaccine. In May, researchers tracking how coronavirus strains behave saw the potential for Omicron subvariants to predominate. Just in case, the companies started building blueprints of shots reformulated to target BA.4, BA.5 and other substrains, and laid the groundwork for testing them. The preparations proved prescient, a big reason, along with manufacturing enhancements, that tens of millions of doses of Pfizer-BioNTech boosters modified to target BA.4 and BA.5 are now rolling out. “If we’re going to be ready for the disease and its migration, I don’t have the time to wait,” said Mike McDermott, Pfizer’s chief global supply officer.
5th Sep 2022 - The Wall Street Journal

So Long to Anthony Fauci, Unlikely Avatar of Polarization

Dr. Anthony Fauci, who announced his pending retirement from the National Institutes of Health on Aug. 22, worked for more than 50 years as a little-known civil servant in a low-profile federal agency. He spent his final two years in government as a highly divisive public figure. Fauci’s sudden rise to national prominence was the accidental consequence of an unforeseen global catastrophe. But he then, perhaps inevitably, found himself enmeshed in today’s polarized political battles. After all, partisan conflict in America increasingly separates those who think well-credentialed experts like Fauci should exert major influence over policy making from those who find that prospect unappealing — or even frightening.
5th Sep 2022 - Bloomberg

COVID app that detects virus in your voice 'more accurate than lateral flow tests'

Users will be required to give information about their medical history, smoking status and demographics and record some respiratory sounds, such as coughing and reading a short sentence.
5th Sep 2022 - Sky News

Pfizer/Biontech Covid-19 Booster Approved by UK Medicines Regulator

An updated Covid-19 booster vaccine has been approved for use in the UK. The second "bivalent" vaccine, made by Pfizer/BioNTech, targets two coronavirus variants and has been approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) in those aged 12 and above. The regulator confirmed on Saturday that the vaccine had met its standards of safety, quality and effectiveness. The vaccine targets both the original strain of coronavirus and the Omicron variant that emerged at the end of 2021, and follows a similar booster from Moderna which was approved in August.
5th Sep 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Sep 2022

View this newsletter in full

CanSino's inhaled COVID-19 vaccine gets emergency use approval in China

China's CanSino Biologics Inc said on Sunday that its recently developed COVID-19 vaccine has been approved by the country's drug regulator for emergency use as a booster, potentially benefiting its business.
4th Sep 2022 - Reuters

Livzon Pharma's COVID-19 vaccine gets emergency use approval in China

China granted emergency use authorisation to Livzon Pharmaceutical Group Inc's COVID-19 vaccine as a booster, the company said on Friday, one of just two new products against the disease the country has cleared in more than a year. Livzon's vaccine, based on the original coronavirus, if rolled out to the general public would widen booster options for China's 1.4 billion population, of which 90% have been vaccinated and nearly 60% have received a booster dose.
2nd Sep 2022 - Reuters

EMA panel backs COVID-19 vaccines targeting Omicron BA.1

The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots. The European Commission said it will move ahead with an accelerated authorisation of the bivalent shots, which include mRNA for the wild-type SARS-CoV-2 spike protein, as well as the original BA.1 subvariant of Omicron, in a divergence from the approach taken by the authorities in the US. The FDA has just authorised vaccines from the two companies that will specifically target the BA.4 and BA.5 subvariants of Omicron, which have now displaced the earlier forms and, for now, are expected to remain dominant through the coming autumn and winter.
2nd Sep 2022 - Pharmaphorum

CDC vaccine advisers vote to recommend updated Covid-19 boosters

Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, signed off Thursday on the recommendation of the agency's independent vaccine advisers in favor of updated Covid-19 vaccine boosters from Pfizer/BioNTech and Moderna. The CDC's Advisory Committee on Immunization Practices voted 13 to 1 earlier in the day to recommend updated mRNA boosters for Americans this fall.
2nd Sep 2022 - CNN

CDC recommends Novavax's COVID-19 vaccine to be used as primary series option for adolescents

COVID-19 may provoke IgA-associated vasculitis. The prevalence and risk factors for delirium in older patients hospitalized with COVID-19. Risk factors among pregnant and postpartum women with COVID-19
2nd Sep 2022 - News-Medical.Net

South Africa Wastewater May Indicate 'Impending' Covid-19 Wave

An increase in Covid-19 virus fragments in wastewater samples “may indicate an impending wave” of infections, the National Institute for Communicable Diseases said. Increases in the frequency of samples in the week ended Aug. 23 were found at water treatment plants near the capital, Pretoria, as well as in Johannesburg and Ekurhuleni, an industrial and residential area that lies between the two cities, the NICD said in a report on Friday. Increased numbers of fragments were also found in the cities of Durban and Bloemfontein, it said.
2nd Sep 2022 - Bloomberg

Pfizer, BioNTech seek to revoke CureVac's patent infringement claims

Pfizer and its German partner BioNTech have filed proceedings at the High Court of England and Wales, seeking a judgment that their COVID-19 vaccine, based on mRNA technology, does not infringe on CureVac's European patents, according to a regulatory filing on Friday. In July, CureVac had filed a patent lawsuit against BioNTech over its use of mRNA technology, seeking fair compensation from the company and two subsidiaries for infringement of its intellectual properly rights.
2nd Sep 2022 - Reuters

Taiwan approves Omicron-targeted Moderna COVID vaccine

Taiwan on Friday approved the use of Moderna Inc's Omicron-targeted COVID-19 vaccine as a booster shot for people aged 18 and over. The Taiwan Food and Drug Administration said it gave approval after an overall assessment of the vaccine's effectiveness and safety as well as the "urgent domestic public health needs". The U.S. Food and Drug Administration on Wednesday authorised updated Pfizer-BioNTech and Moderna booster shots that target the dominant BA.4 and BA.5 Omicron subvariants of the virus.
2nd Sep 2022 - Reuters

CDC Panel Backs Moderna, Pfizer Covid Omicron Boosters

Covid booster shots that target the most common new variants of the virus should become available in the US within days, after the Centers for Disease Control and Prevention signed off on the rollout of updated vaccines Thursday. CDC Director Rochelle Walensky endorsed the use of the new shots after, in two 13-1 votes, outside vaccine and health experts gave their backing to the booster shots from Moderna Inc. and from Pfizer Inc. and BioNTech SE.
1st Sep 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Sep 2022

View this newsletter in full

Covid-19 Boosters Targeting Omicron Reviewed by CDC Advisers

Immunization experts advising the federal government recommended newly authorized Covid-19 booster shots, the next step toward making the reformulated doses widely available. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13 to 1 in two votes on Thursday that anyone who was already eligible for a booster should now get the reformulated shots, which target both the original virus and Omicron subvariants BA.4 and BA.5.
1st Sep 2022 - The Wall Street Journal

White House Warns of Pandemics Worse Than Covid as Health Overhauls Begin

White House health officials warned that new pandemics could prove more serious than Covid-19 in a report that reviews efforts to prepare for the “high likelihood” of future serious outbreaks. While the Biden administration has pushed repeatedly for funding to combat that sort of threat, Congress has yet to allocate more money. In the meantime, the Centers for Disease Control and Prevention is embarking on a reorganization based on lessons learned during Covid, and another government office is being given new powers to help coordinate responses to health emergencies. “As staggering as the losses of the last nearly three years have been, COVID-19 was a moderate pandemic,” Biden administration officials from the White House Office of Science and Technology Policy and the Covid-19 Response Team said in the report. “The US government must seize the moment to transform its scientific capabilities in preparation for the increasing frequency of biological threats on the horizon.”
1st Sep 2022 - Bloomberg

EU drug agency recommends approval of Covid vaccine boosters for Omicron

The European Union's drug regulator on Thursday backed two separate Covid-19 vaccine boosters updated to target the Omicron variant and developed by Moderna and the team of Pfizer and BioNTech. Europe is preparing to roll out shots ahead of an anticipated rise in infections this winter. The new so-called bivalent shots combat the BA.1 version of Omicron and the original virus first detected in China. The recommendation is to authorise the vaccines for people aged 12 years and above who have received at least primary vaccination against Covid-19, the European Medicines Agency (EMA) said.
1st Sep 2022 - France24

Vaxart Shares Positive Top-line Data From Mid-Stage Oral Pill COVID-19 Vaccine Study

Vaxart announced positive top-line data from the first part of a planned two-part Phase 2 study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S. The top-line data readout exhibited that the trial met its primary safety and secondary immunogenicity endpoints.
1st Sep 2022 - Business Insider

Covid-19 death rates aren’t falling much further. Why?

Deaths from Covid-19 are at some of their lowest rates in the United States since the start of the pandemic, but they’re still alarmingly high, according to some health officials. The Centers for Disease Control and Prevention reported this week that, on average, close to 400 people are dying of the disease every day. The total number of cases, hospitalizations, and deaths is trending downward, albeit at an agonizingly slow pace. And as summer gives way to fall, federal health officials are bracing for another spike in cases. The good news is that it’s unlikely the Covid-19 surge expected this fall will rack up tolls anywhere near those last year or the year before, given how much immunity is now present throughout the population. More than 79 percent of Americans have had at least one dose of a Covid-19 vaccine, 67 percent have had two, and 33 percent have had three.
1st Sep 2022 - Vox.com

FDA authorizes Moderna and Pfizer's updated COVID-19 booster shots

The US regulator has granted emergency authorization for Pfizer-BioNTech’s and Moderna’s Covid booster shots that target the highly contagious BA.5 omicron subvariant.
1st Sep 2022 - BioPharma-Reporter

S.Africa's Aspen, India's Serum Institute sign vaccines deal for Africa

Deal to utilise Aspen's near-idle COVID vaccine production lines. Production under deal will not start before 12 months. Aspen expecting orders for more vaccines from GAVI, UNICEF. Its full-year profit jumps 31%, revenue up 2%
1st Sep 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Sep 2022

View this newsletter in full

Covid-19 Booster Shots Targeting Omicron Authorized, Likely to Be Offered Soon

U.S. health regulators cleared use of retooled Covid-19 vaccines that target the latest versions of Omicron, in preparation for a fall booster campaign that could start within days. The action by the Food and Drug Administration on Wednesday permits people 12 years and older to receive an additional shot of the vaccine from Pfizer Inc. and BioNTech SE, and people 18 and older to receive a Moderna Inc. booster at least two months after their most recent dose. The clearance marks the first changes to the composition of the Covid-19 vaccines since their distribution began in the U.S. in December 2020.
1st Sep 2022 - The Wall Street Journal

Omicron Booster Shots Cleared by FDA to Fight Latest Covid Variants

Covid-19 boosters from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE that are tailored to the latest omicron variants got US regulatory clearance, a move toward additional protection as concern grows about potential new waves in the fall and winter. The emergency use authorization is for use of a dose of Moderna’s shot in adults 18 and older, while Pfizer’s can be used in people 12 and older, the Food and Drug Administration said Tuesday in a statement. The booster must be given at least two months after recipients’ latest Covid shot.
1st Sep 2022 - Bloomberg

FDA clears updated COVID-19 vaccines ahead of fall booster campaign

The Food and Drug Administration on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron. The move comes ahead of a fall campaign to give Americans additional booster jabs to protect them against variants.
31st Aug 2022 - The Hill

FDA authorizes Pfizer and Moderna's updated Covid-19 boosters

The US Food and Drug Administration on Wednesday authorized updated Covid-19 vaccine booster shots from Moderna and Pfizer. This is the first time updated Covid-19 vaccines have received emergency use authorization in the United States.
31st Aug 2022 - CNN

Study explores differences in the efficiency of COVID-19 vaccine boosters

In the present study, researchers performed a meta-analysis using currently available data on neutralization titers obtained from clinical studies that compared the booster COVID-19 vaccination with the currently available SARS-CoV-2 ancestral strain- or variant-based vaccines. The team compared the average extent of boosting between vaccines based on the ancestral strain and those modified as per the variant by comparing the increase in neutralization titers noted before and after booster dose administration. Furthermore, the study compared the magnitude of boosting against the homologous strains, wherein the variants used in the vaccine and the neutralization assay are the same, versus non-homologous strains, wherein the variants used in the vaccine and the neutralization assay are different.
31st Aug 2022 - News-Medical.Net

There’s some good news in the battle against long Covid

There is also some indication we may be getting closer to more precisely defining and treating long Covid. Many studies around the world have been set up to recruit groups with long Covid to compare them with “rapid recovery” cases – people who recovered quickly and fully from Covid – to try to find differences in levels of antibodies, hormones, immune cells or other things that can be measured with a blood test. These so-called “defining biomarkers” can be gamechangers. They can help health services define and refer cases, provide more extensive evidence for employers and tribunals, and also point towards identification of therapies and treatments. One of the first such studies was reported this month in a preprint from Akiko Iwasaki, David Putrino and colleagues at Yale. They report a clear biomarker delineating differences in the long Covid group, with signals including low serum cortisol (a hormone involved in control of the stress response) and evidence of reactivation of latent Epstein-Barr virus.
31st Aug 2022 - The Guardian

Scientists Boost Immune Response to COVID-19 Vaccine by 25 Times

Ironically, some vaccines need their own “boosters.” An ingredient called an adjuvant can be added to vaccines to help elicit a more robust immune response, better training the body to fight a pathogen. Scientists report a substance that boosted the immune response to an experimental COVID-19 shot in mice by 25 times, compared to injection with the vaccine alone. Details of the research are described in a new paper published today (August 31, 2022) in the journal ACS Infectious Diseases.
31st Aug 2022 - SciTechDaily

Moderna sues Pfizer and BioNTech over COVID-19 vaccine

One patent in question has to do with a modification to the mRNA delivered in the vaccine. A big hurdle in creating mRNA medicines was that the immune system would destroy the mRNA before it could act, Moderna describes in the complaint. The structure of 1-Methylpseudouridine. Four different units, called nucleosides, make up mRNA. Moderna says it discovered that swapping out one of them, uridine, with 1-methylpseudouridine resulted in better protein production than previous modification attempts and diminished the problematic immune response. Moderna says it patented this research and that Pfizer and BioNTech used the same modification.
31st Aug 2022 - Chemical & Engineering News

Greater regular physical activity reduces risk of adverse COVID-19 outcomes

Greater regular physical activity reduces the risk of infection, hospitalisation, severe illness and death from COVID-19 in comparison to those who are inactive according to the findings of a systematic review and meta-analysis by a team of Spanish researchers. Some degree of physical activity is better than none but greater regular physical activity is best for optimal health outcomes according to a World Health Organisation guideline from 2020. Physical activity has a beneficial impact on the immune system and also appears to have protective associations against infectious disease mortality. Moreover, it also appears that the converse is true, particular in relation to COVID-19. For example, in a study of over 48,440 adult patients with a COVID-19, those who were physically inactive had a higher risk of hospitalisation, admission to intensive care and death compared to those who were consistently meeting physical activity guidelines.
31st Aug 2022 - Hospital Healthcare Europe

Australian Institute of Health and Welfare gets $2M for COVID-19 linked data project

The Australian Institute of Health and Welfare is receiving A$2.9 million ($2 million) from the federal government for its COVID-19 linked data project. The agency is one of the 14 research groups being funded a total of A$31.5 million ($22 million) by the government's Medical Research Future Fund to help improve Australia's understanding of COVID-19.
31st Aug 2022 - Healthcare IT News

Vitamin D mediates crosstalk between COVID-19 and osteoporosis

The global outbreak of the highly infectious severe acute respiratory syndrome coronavirus 2 (SARS–COV-2) resulted in the pandemic of the coronavirus disease 2019 (COVID-19), which has claimed over 6.4 million lives worldwide to date. Several types of COVID-19 vaccines have been developed, many of which have received approval from global regulatory bodies. However, genomic mutations have led to the emergence of new SARS-CoV-2 variants, which have reduced the effectiveness of these vaccines.
31st Aug 2022 - News-Medical.Net

SaNOtize bags $24M to fund phase 3 trial of COVID-19 nasal spray

SaNOtize has raised a $24 million series B round, giving it the cash to fund its ongoing phase 3 COVID-19 prevention trial and other research into its nitric oxide nasal spray (NONS). The Vancouver-based company set up shop in 2017 to unlock the antimicrobial properties of nitric oxide. Using its nitric oxide releasing solution platform, SaNOtize sought to enable the use of the molecule in sprays, baths, lavages, gels and creams. Interest in the platform went up a gear in 2020 when COVID-19 created a pressing need for interventions capable of treating and preventing SARS-CoV-2 infection. While drugs and vaccines have blunted the impact of COVID-19, SaNOtize sees a continued need for new tools for managing the coronavirus—and has persuaded investors to bankroll its pursuit of the perceived opportunity. Horizons Ventures and OurCrowd co-led the series B round.
31st Aug 2022 - FiercePharma

CDC advisers to decide on Omicron-retooled boosters on Sept 1

Advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Thursday to vote on whether to recommend the use of two COVID-19 vaccine boosters tailored against the Omicron variant. A recommendation in favor of the modified vaccines by Pfizer Inc and its German partner BioNTech SE, as well as Moderna Inc is expected to pave the way for a rollout next week.
31st Aug 2022 - Reuters

U.S. life expectancy fell further in 2021 due to COVID

Life expectancy fell in the United States in 2021 to its lowest since 1996, the second year of a historic retreat due to COVID-19 deaths, provisional government data showed on Wednesday. The nearly one-year decline from 2020 to 76.1 years marked the largest two-year drop in life expectancy at birth in close to a century, the U.S. Centers for Disease Control and Prevention (CDC) found. Disparity in life expectancy between men and women also widened last year to the highest in more than two decades, with men now expected to live 73.2 years, nearly six fewer years than women.
31st Aug 2022 - Reuters

Melbourne launches multimillion-dollar centre for pandemic treatments

Melbourne will bid to become a global centre for the development of new antiviral therapies to deal with future pandemics after receiving the largest donation in Australian medical history. Geoff Cumming, a Canadian who lives in the city, has pledged at least A$250mn ($172mn) towards creating The Cumming Global Centre for Pandemic Therapeutics based in Parkville, adjacent to the University of Melbourne.
31st Aug 2022 - Financial Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 31st Aug 2022

View this newsletter in full

MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization

Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK. Novavax announced on Aug. 26, 2022 that the company’s COVID-19 vaccine, Nuvaxovid, was granted expanded conditional marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency. This authorization allows for the use of the vaccine in adolescents aged 12 to 17. According to a company press release, the authorization is based on data from the Phase III PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the United States. The trial reached its primary effectiveness endpoint and demonstrated 80% clinical effectiveness. "As we start to prepare for a potential fall surge, we are pleased to offer the first protein-based COVID-19 vaccine to adolescents aged 12 through 17 in the UK," said Stanley C. Erck, president and CEO, Novavax, in the release.
30th Aug 2022 - PharmTech

AIVITA Biomedical announces publication of trial results of its COVID-19 vaccine

Safety and efficacy results from phase 1 and 2 clinical trials looking at a Covid-19 vaccine made at point-of-care by third party personnel have been published. AIVITA Biomedical Inc., a biotech specializing in cell applications, made the announcement today (August 29). The results were published in the article in the journal Human Vaccines & Immunotherapeutics.
30th Aug 2022 - Labiotech.eu

Japan OKs third Pfizer shot for children and AstraZeneca COVID treatment

The health ministry on Tuesday approved a third dose of the Pfizer COVID-19 vaccine for children between the ages of 5 and 11, after an expert panel gave the plan the green light the day before. It is hoped the move will help prevent children in that age group from getting infected with the coronavirus and developing severe symptoms, as the nation continues to see high levels of cases driven by the highly infectious BA.5 omicron subvariant. The booster shot will be available to such children five months or more after they have received their second dose. The health ministry said the panel has judged that the booster shot is safe enough for children in the age group. Side effects reported in clinical trials include fatigue and soreness around the site of the shot, as well as fever, but most people have recovered having had only minor or moderate reactions, the ministry said.
30th Aug 2022 - The Japan Times

MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization

Novavax announced on Aug. 26, 2022 that the company’s COVID-19 vaccine, Nuvaxovid, was granted expanded conditional marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency. This authorization allows for the use of the vaccine in adolescents aged 12 to 17. According to a company press release, the authorization is based on data from the Phase III PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the United States. The trial reached its primary effectiveness endpoint and demonstrated 80% clinical effectiveness. "As we start to prepare for a potential fall surge, we are pleased to offer the first protein-based COVID-19 vaccine to adolescents aged 12 through 17 in the UK," said Stanley C. Erck, president and CEO, Novavax, in the release.
30th Aug 2022 - BioPharm International

Risk factors among pregnant and postpartum women with COVID-19

In a recent study published in the American Journal of Obstetrics and Gynecology, researchers investigated the clinical risk factors associated with adverse outcomes among coronavirus disease 2019 (COVID-19)-infected women during pregnancy and postpartum.
30th Aug 2022 - News-Medical.Net

AstraZeneca gains first approval for Evusheld as COVID-19 treatment

AstraZeneca's long-acting antibody combination Evusheld has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection: marking the first global marketing approval of Evusheld as a treatment for COVID-19.
30th Aug 2022 - BioPharma-Reporter.com

The growing evidence that Covid-19 is leaving people sicker

A Financial Times analysis of data from the UK’s NHS, one of the world’s richest health data sets, showed significant rises in deaths from heart disease since the start of the pandemic in all but the very oldest age groups. In the 40-64 age group, heart attack deaths increased 15 per cent in 2021 compared with 2019. In February, meanwhile, an analysis of more than 150,000 records from the national healthcare databases at the US Department of Veterans Affairs suggested that even some people who had not been seriously ill with Covid had an increased risk of cardiovascular problems for at least a year afterwards. Researchers found that rates of many conditions, such as heart failure and stroke, were substantially higher in people who had recovered from Covid than in similar people who had not been infected. A separate analysis of VA data, published in March, suggested that in the “post-acute phase” of the disease, people with Covid “exhibit increased risk and burden of diabetes”.
30th Aug 2022 - Financial Times

Japan panel approves AstraZeneca's Evusheld COVID treatment

Japan's health ministry said on Monday that its panel of experts had agreed to approve manufacturing and sales of AstraZeneca's COVID-19 preventive treatment Evusheld. Evusheld is designed to protect against COVID infection for at least six months, and has been deployed in many countries for people with compromised immune systems who see little or no benefit from vaccines. The panel also gave its consent to using Pfizer's COVID-19 vaccine for booster shots for children aged five to 11, the ministry said.
30th Aug 2022 - Reuters

Swiss drugs regulator approves first bivalent Covid-19 booster

Swiss drugs regulator Swissmedic said on Monday that it has approved the first bivalent Covid-19 booster vaccine in the country. Moderna's Spikevax vaccine, which contains mRNA against two coronavirus variants, is authorized for anyone 18 years or older, said Swissmedic.
30th Aug 2022 - Reuters

Moderna patent fight about feathers, not goose

Moderna’s claim that the Covid-19 vaccine developed by Pfizer and partner BioNTech used its intellectual property sounds explosive. The sums at stake are potentially huge, as the drug giant estimates sales of the vaccine will be $32 billion this year. It’s in nobody’s interest to kill this golden goose though. The most likely result will simply be lots of legal hissing, and at worst for Pfizer, a few plucked feathers.
29th Aug 2022 - Reuters

China's CanSinoBIO H1 revenue drops on weaker COVID shot demand

China's CanSino Biologics (6185.HK) reported a 69.5% drop in revenue for the first six months versus a year ago, joining global and domestic COVID-19 vaccine makers affected by waning demand for their shots. The decline from 2.06 billion yuan ($299.8 million) to 629.8 million yuan was mainly driven by weaker COVID vaccine demand as growth in global uptake slowed and price changes of CanSinoBIO's products, the firm said in a company filing published on Sunday.
29th Aug 2022 - Reuters

How Quickly Can You Get Infected With Omicron After An Exposure?

Early in the pandemic, an exposure to COVID meant waiting anxiously for many days to see if you were infected. Now, the window is getting smaller and smaller, according to a new review published in the journal JAMA Network Open. Researchers analyzed 141 studies to determine how COVID’s incubation period ― the time from when you get infected to when you start showing symptoms ― has changed since March 2020. The study, which was conducted by scientists in Beijing, found that with every new variant, COVID’s incubation time has decreased significantly. Omicron, which is the current dominant variant in the United States, has the shortest time between infection and symptoms. “The incubation periods of COVID-19 caused by the Alpha, Beta, Delta and Omicron variants were 5.00, 4.50, 4.41, and 3.42 days, respectively,” the study stated.
29th Aug 2022 - Huffington Post

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Aug 2022

View this newsletter in full

Hong Kong to Expand Covid Testing Across City as Virus Cases Surge

Hong Kong imposed a select set of measures to try to protect its most vulnerable from a surging Covid-19 outbreak that is putting the city’s health care system under pressure, and forcing the government to take action. The Asian financial hub will expand testing across the city, while holding off on the full-scale closures and tighter mitigation measures it’s used in the past, and which are still frequently deployed in mainland China now. The aim is to balance the health of its people with the city’s economic needs, officials said. Those who test positive for Covid will be sent to isolation facilities with their families if any of them are at high risk and their living conditions don’t provide adequate space, Secretary for Health Lo Chung-mau said at the daily virus briefing
29th Aug 2022 - Bloomberg

COVID-19 mortality surveillance in Lebanon

Since the beginning of the COVID-19 pandemic, the Epidemiological surveillance program of the Lebanese Ministry of Public Health has launched a rapid surveillance system for collecting COVID-19-related mortality data. In this study, we document the Lebanese experience of COVID-19 mortality surveillance and provide an analysis of the epidemiological characteristics of confirmed deaths. The implementation of the rapid COVID-19 mortality surveillance system, data sources, and data collection were described. A retrospective descriptive analysis of the epidemiological characteristics of confirmed cases occurring in Lebanon between February 20, 2020, and September 15, 2021, was performed.
27th Aug 2022 - Nature.com

Beneficial non-specific effects of live vaccines against COVID-19 and other unrelated infections

Live attenuated vaccines could have beneficial, non-specific effects of protecting against vaccine-unrelated infections, such as BCG protecting against respiratory infection. During the COVID-19 pandemic, testing of these effects against COVID-19 was of interest to the pandemic control programme. Non-specific effects occur due to the broad effects of specific live attenuated vaccines on the host immune system, relying on heterologous lymphocyte responses and induction of trained immunity. Knowledge of non-specific effects has been developed in randomised controlled trials and observational studies with children, but examining of whether the same principles apply to adults and older adults was of interest to researchers during the pandemic.
27th Aug 2022 - The Lancet

MOH to offer COVID-19 booster shot for children aged 5 to 11

Children aged 5 to 11 are now recommended to receive one booster dose of the Pfizer-BioNTech/Comirnaty vaccine, from five months after the second dose of their primary vaccination series. Preparations are under way to start inoculating the group in the fourth quarter of the year, “likely when examinations in primary schools are towards the tail end or over”, the Ministry of Health (MOH) said in a news release on Wednesday (Aug 24) The move comes on the recommendation of the Expert Committee on COVID-19 Vaccination. MOH said that the booster dose will sustain protection against severe illness and strengthen Singapore's preparation for the next infection wave.
27th Aug 2022 - Channel NewsAsia Singapore

Hong Kong gears up for Covid fight as health chief warns tighter curbs possible

Secretary for Health Lo Chung-mau says changes to quarantine rules for elderly are justified because of a resurgence of coronavirus infections. Health authorities confirm 7,835 new coronavirus infections, including 170 imported ones, as well as seven more related deaths
27th Aug 2022 - South China Morning Post

Moderna sues Pfizer/BioNTech for patent infringement over COVID vaccine

Moderna sued Pfizer and its German partner BioNTech on Friday for patent infringement in the development of the first COVID-19 vaccine approved in the United States, alleging they copied technology that Moderna developed years before the pandemic. The lawsuit, which seeks undetermined monetary damages, was filed in U.S. District Court in Massachusetts. The suit also would be filed also in the Regional Court of Duesseldorf in Germany, Moderna said in a news release.
26th Aug 2022 - Reuters

Britain approves Novavax COVID shot for 12-17 year-olds

Britain's medicines regulator on Friday approved Novavax's COVID-19 vaccine for children aged between 12 and 17 years. The mRNA vaccines made by Moderna as well as the partnership between Pfizer-BioNTech are also cleared for use by this age group, the Medicines and Healthcare products Regulatory Agency (MHRA) said. Britain in February cleared Novavax's two-dose vaccine, Nuvaxovid, for use in adults.
26th Aug 2022 - Reuters UK

Booster Shots Protect Against Severe Covid for at Least Six Months, Study Finds

A Covid-19 vaccine booster shot protects people from becoming severely ill or dying and its efficacy lasts for six months, according a study published in the Journal of the American Medical Association, underscoring the importance of additional jabs as the world moves to coexist with the virus. The mRNA booster vaccines -- made by drugmakers Pfizer Inc. and BionTech SE, or Moderna Inc. -- were most effective in cutting the rate of people with severe Covid, scoring an estimated 87%, and there was no evidence of their effect waning within six months, the study found. Inactivated booster vaccines by Sinovac Biotech Ltd. and Sinopharm Group Co. also cut the chance of severe illness by about 70%. Severe Covid was defined in the research as requiring oxygen supplementation, intensive care or death.
26th Aug 2022 - Bloomberg

Do I need a Covid Booster Shot? Astrazeneca (AZ) Boss Wonders If Good Idea

The boss of pharmaceutical giant AstraZeneca has said he is unsure whether annual Covid-19 boosters for otherwise healthy people are a good use of resources or money. A new booster jab will be offered to everyone in the UK aged 50 and over from next month, as well as those with underlying health conditions, to increase protection ahead of future waves. Chief executive officer Pascal Soriot said he believes most of the vaccinated population has a "foundation immunity against severe disease" at this point. In an interview with the Telegraph, he said: "People who are otherwise healthy - especially if they are young, have been vaccinated, have had a boost already - boosting them again, I'm just not sure it's really a good use of resources."
26th Aug 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Aug 2022

View this newsletter in full

Pfizer COVID-19 Vaccines 73 Percent Protective in Under 5s

The Pfizer modified COVID-19 vaccine for use in children younger than 5 years was 73 percent effective in shielding them from infection during the omicron surge this spring, company data released Tuesday show. The specially formulated doses for America’s youngest children were approved for distribution in June, although the American Academy of Pediatrics says uptake has been low. Just 6 percent of children younger than 5 years had gotten immunized by mid-August, the group said. At the time of approval, the only studies supporting their use in small children were based on levels of antibodies triggered by the shots. The new data show that the Pfizer vaccine does appear to protect young children well against symptomatic COVID-19.
25th Aug 2022 - Physicians Weekly

Wait for Bharat's COVID-19 vaccine data continues

India's Bharat Biotech has recently completed the Phase III trials of its COVID-19 intranasal vaccine BBV154 and submitted the data to the Drug Controller General of India (DCGI) for approval both as a primary two-dose vaccine, and a heterologous booster dose. However, the company has not yet made clinical trial results publicly available.
25th Aug 2022 - The Pharma Letter

COVID Has Set Back Childhood Immunizations Worldwide

Thanks to COVID vaccines, more people were immunized in 2021 than in any other year in history. Yet that same year, with tragic irony, more children ended up at risk of highly preventable infectious diseases than before the pandemic began. This is because of what the World Health Organization and UNICEF have described as the largest backslide in childhood vaccinations in three decades. It means that, for the second year in a row after 2019, at a time when the COVID pandemic has focused the world’s attention on the need for vaccination, the number of children missing out on basic vaccines has increased. This is particularly the case in lower-income countries. Given the enormous toll COVID is having on the world’s poorest economies, an overall decline in childhood vaccinations is not unexpected. But we can’t let these numbers slip further.
25th Aug 2022 - Scientific American

Paxlovid reduces risk of COVID-19 death by 81%, Clalit study shows

A study by Clalit Health Services on the success of treating at-risk COVID-19 patients with the anti-viral drug Paxlovid has shown an impressive 81% reduction in the risk of death from complications of the virus and a 73% decrease in hospitalizations among those aged 65 and older, compared to a control group who did not want to take the medication. Generically known as nirmatrelvir/ritonavir, the oral protease inhibitor was granted emergency use authorization by the US Food and Drug Administration (FDA) in December 2021. It was authorized for treatment of mild-to-moderate COVID-19 in people aged 12 years of age and older weighing at least 40 kilograms with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. It should be taken within five days of the onset of symptoms.
25th Aug 2022 - The Jerusalem Post

Nirmatrelvir Use and Severe Covid-19 Outcomes during the Omicron Surge | NEJM

A total of 109,254 patients met the eligibility criteria, of whom 3902 (4%) received nirmatrelvir during the study period. Among patients 65 years of age or older, the rate of hospitalization due to Covid-19 was 14.7 cases per 100,000 person-days among treated patients as compared with 58.9 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.27; 95% confidence interval [CI], 0.15 to 0.49). The adjusted hazard ratio for death due to Covid-19 was 0.21 (95% CI, 0.05 to 0.82). Among patients 40 to 64 years of age, the rate of hospitalization due to Covid-19 was 15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.74; 95% CI, 0.35 to 1.58). The adjusted hazard ratio for death due to Covid-19 was 1.32 (95% CI, 0.16 to 10.75).
25th Aug 2022 - The New England Journal of Medicine

What is the link between influenza vaccination and the severity of COVID-19 infection?

In a recent study published in Scientific Reports, researchers performed a systematic review and meta-analysis to investigate whether influenza vaccinations could reduce coronavirus disease 2019 (COVID-19) severity outcomes. However, results on the potential protection against COVID-19 severity by influenza vaccines have been contradictory.
25th Aug 2022 - News-Medical.Net

Severe COVID-19 increases risk of future cardiovascular events

To date, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which is the virus responsible for the coronavirus disease 2019 (COVID-19), has infected over 603 million individuals and claimed more than 6.4 million lives worldwide. About 30% of COVID-19 survivors continue to experience a wide range of persistent symptoms for several weeks since their initial diagnosis. This condition is commonly referred to as post-acute sequelae of SARS-CoV-2 infection (PASC) or “long COVID.”
25th Aug 2022 - News-Medical.Net

Paxlovid reduces risk of COVID-19 death by 81%, Clalit study shows

Thai FDA approves Pfizer COVID-19 vaccine for children aged 6 months -5 years

COVID-19 vaccine in vials with maroon caps, developed by Pfizer, are now approved for use in children aged 6 months to 5 years, with 3 injections of 3µg per dose. The vaccine is 80.3% effective at preventing COVID-19. Secretary-General of Thailand’s Food and Drug Administration (TFDA) Dr. Paisarn Dunkum said yesterday (Wednesday) that, on August 23rd, the TFDA subcommittee considering the registration of modern pharmacopoeia for humans, as a vaccine against the virus which causes COVID-19, approved the expansion of the use of Pfizer’s Comirnaty vaccine to include children aged 6 months to 5 years.
25th Aug 2022 - Thai PBS World

Thai king's medical firm reports record profit after vaccine deal with AstraZeneca

Thai drugmaker Siam Bioscience, owned by the country's king, reported a near 50-fold increase in annual profit in 2021, when it began producing AstraZeneca Plc's COVID-19 vaccine, government data shows. The company is part of King Maha Vajiralongkorn's vast fortune, which includes land and property estimated at between $30 billion and $60 billion. Founded in 2009 by the late King Bhumibol Adulyadej to produce biopharmaceuticals and improve public health, the company had since been loss-making and reported its first profit only in 2020 of 35.7 million baht ($995,000).
25th Aug 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Aug 2022

View this newsletter in full

Singapore extends use of Moderna's COVID-19 vaccine for kids

The Health Sciences Authority (HSA) in Singapore has extended the authorisation of Moderna’s Spikevax COVID-19 vaccine via the Pandemic Special Access Route (PSAR), for the prevention of COVID-19)in individuals 6 months to 5 years- administered as a course of two 25 microgram doses; 6 to 11 years- administered as a course of two 50 microgram doses; and 12 to 17 years- administered as a course of two 100 microgram doses. HSA has carefully considered the data from two clinical studies in children and adolescents, and assessed that the benefits outweighed the risks for use of Spikevax in individuals aged 6 months and above. In making this regulatory decision, HSA also consulted expert advice from the Medicines Advisory Committee and Panel of Infectious Diseases Experts. Safety data from the clinical studies also showed that adverse events in adolescents and children were similar to those reported in adults.
25th Aug 2022 - BioSpectrum Asia

Over 2 Million Americans Aren't Working Due to Long Covid, Says Brookings

Between two million and four million Americans aren’t working due to the long-term effects of Covid-19, according to a new Brookings Institution report released Wednesday. The inability to work translates to roughly $170 billion a year in lost wages, the report estimates. It follows a January Brookings Institution report that estimated long Covid was potentially causing 15% of the country’s labor shortage. The report estimates that roughly 16 million Americans of working age—between 18 and 65—have long Covid, which most groups and doctors define as wide-ranging symptoms that persist for months following an infection and can include shortness of breath, extreme fatigue and neurocognitive issues.
24th Aug 2022 - The Wall Street Journal

Moderna seeks FDA EUA for Covid-19 booster vaccine

Moderna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. mRNA-1273.222 acts on the SARS-CoV-2 virus’ initial strain and the Omicron’s subvariants BA.4/BA.5.
24th Aug 2022 - Pharmaceutical Technology

Five per cent of COVID-19 patients are likely to develop long COVID

Professor Jason Kovacic says it's likely the chances of developing long COVID-19 increase the more times you contract the virus.
24th Aug 2022 - ABC News

Absolute vaccine effectiveness for third and fourth doses of mRNA COVID-19 vaccine against Omicron

In the current work, the researchers sought to determine the three-dose and four-dose SARS-CoV-2 vaccine series aVE at the same point after vaccination. They calculated the aVE for the third and fourth doses of COVID-19 mRNA vaccine compared to receiving no vaccination towards Omicron, considering clinical outcome utilizing a set of logistic regression equations and VE estimations for a fourth dosage compared to a third dose described in an Israeli investigation. Based on information from the United Kingdom Health Security Agency (UKHSA), the authors previously released a logistic regression equation that forecasts aVE, including waning with time, for the third COVID-19 mRNA vaccine dose irrespective of the initial course, against symptomatic infection and hospitalization associated with Omicron. Further, they used a study that reported VE per age against the SARS-CoV-2 Delta variant to expand this equation to account for age variability in VE.
24th Aug 2022 - News-Medical.Net

WHO advice on second booster doses for COVID-19

A new generation of coronavirus vaccine is being developed by Swedish researchers from the Karolinska Institutet. The vaccine is being specifically designed to be less sensitive to mutations and better equipped for any future strains. The vaccine showed promising results in mice in a newly published study in EMBO Molecular Medicine, and the researchers now hope to be able to take it to safety studies on humans. Matti Sällberg, professor at the department of laboratory medicine, Karolinska Institutet said:“This is a new generation of corona vaccine. “The idea is that it will give broader protection that more resembles that gained after an actual infection and will be a bit more future-proof than the vaccines currently in use.”
24th Aug 2022 - BioPharma-Reporter.com

COVID-19 vaccine less sensitive to mutations developed in Sweden

Pfizer-BioNTech COVID shot 73.2% effective in kids under 5 - new data

Pfizer Inc and BioNTech's vaccine was 73.2% effective in preventing COVID-19 among children aged 6 months through 4 years, new data from the companies showed on Tuesday, two months after the U.S. rollout of the shots began for that age group. The Pfizer-BioNTech vaccine was authorized for children under 5 years of age in June, based on data that showed the vaccine generated a similar immune response as in older age groups. An early analysis based on 10 symptomatic COVID-19 cases in the study had suggested a vaccine efficacy of 80.3%. But experts had warned that the data was preliminary due to a low number of symptomatic cases.
24th Aug 2022 - Yahoo News UK

Exclusive: AstraZeneca may not stay in vaccines, but CEO has no COVID regrets

AstraZeneca may not stay in the vaccine business in the long run, its CEO told Reuters on Tuesday, showing how quickly fortunes have changed for the drugmaker that produced one of the first COVID-19 shots but has since lost out to rivals. Production delays, probes by regulators following rare cases of severe side effects, and concerns about its relatively short shelf life compared with other shots have stymied adoption of the company's COVID-19 vaccine.
24th Aug 2022 - Reuters

Moderna seeks FDA nod for booster shot aimed at Omicron BA.4, BA.5

Moderna Inc sought U.S. authorization for its COVID-19 booster shot tailored against the BA.4 and BA.5 subvariants of Omicron and said if cleared it would be ready to deliver the doses in September. Its application with the U.S. Food and Drug Administration (FDA) is based on pre-clinical data for the so-called bivalent dose that contains the dominant BA.4/BA.5 variants along with the original coronavirus strain.
24th Aug 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Aug 2022

View this newsletter in full

EMA evaluating Skycovion COVID-19 vaccine

EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK. The evaluation of data for ...
23rd Aug 2022 - BioPharma-Reporter

Pfizer and BioNTech seek FDA EUA for Omicron-based Covid-19 vaccine

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution.
23rd Aug 2022 - Pharmaceutical Technology

Study reveals safety of COVID mRNA vaccines for patients with heart failure

COVID mRNA vaccines are associated with a decreased risk of death in patients with heart failure, according to research presented at ESC Congress 2022. The study also found that the vaccines were not associated with an increased risk of worsening heart failure, venous thromboembolism or myocarditis in heart failure patients.
23rd Aug 2022 - News-Medical.Net

FDA authorizes Novavax's COVID-19 vaccine for teens

The Food and Drug Administration on Friday cleared Novavax’s coronavirus vaccine for emergency use in children 12 to 17 years old, giving adolescents a third option to prevent COVID-19 as they return to school. The agency’s decision comes a month after the FDA authorized the shot for adults and more than a year after teenagers became eligible for the messenger RNA shots from Pfizer and, later, Moderna. The Centers for Disease Control and Prevention signed off on the FDA’s decision Monday.
23rd Aug 2022 - BioPharma Dive

Your first brush with coronavirus could affect how a fall booster works

In the beginning, when the coronavirus was new, the quest for a vaccine was simple. Everyone started out susceptible to the virus. Shots brought spectacular protection. But the next chapters of life with the virus — and the choice of booster shots for the fall and beyond — will be complicated by the layers of immunity that now ripple through the population, laid down by past infections and vaccinations. When it comes to viral infections, past is prologue: The version of a virus to which we’re first exposed can dictate how we respond to later variants and, maybe, how well vaccines work.
23rd Aug 2022 - The Washington Post

Struggling with brain fog after a COVID-19 infection? You're not alone, experts say

COVID-19 is linked to an increased risk of developing brain fog and dementia after an infection, according to a recent medical study. More than 596 million COVID-19 cases have been recorded globally — including nearly 10 million in Australia — and many of the long-term impacts are yet to be seen. However, the recent study helps shed light on the risk of neurological disorders after an infection. Here's what we know about brain fog and how COVID-19 affects your brain.
23rd Aug 2022 - ABC News

Incidence of type 2 diabetes in youth increased during COVID-19 pandemic

The onset of type 2 diabetes (T2D) among the youth is rising globally. In fact, a 5% increase in its incidence was reported by the SEARCH for Diabetes in Youth Study from 2002 to 2012 in the United States, while its incidence nearly doubled between 2001 and 2017. The Treatment Options for T2D in Youth (TODAY) study has shown that such an increase can lead to rapid β-cell failure, along with the early onset of numerous complications in approximately half of the youth with T2D in the U.S.
23rd Aug 2022 - News-Medical.Net

What do we know about covid-19 vaccines in under 5s?

It took a year for covid-19 vaccines to be tested and approved for use in children. As countries now reach out to the youngest age group, David Cox reports on the evidence for their effectiveness and deployment. On 18 June 2022, regulators in the US voted to authorise the rollout of Pfizer and Moderna’s covid-19 vaccines to children under the age of 5, meaning that the jabs will now be available to an estimated 20 million babies and toddlers.1 The decision sees the US join Argentina, Bahrain, Chile, China, Cuba, Hong Kong, the United Arab Emirates, and Venezuela in offering covid-19 vaccines to the youngest age category. Regulators in Europe are predicted to follow in the coming weeks.
23rd Aug 2022 - The BMJ

Pfizer's COVID vaccine 73.2% effective in kids under 5, new data shows

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Aug 2022

View this newsletter in full

Pfizer, BioNTech Seek FDA Authorization for Updated Covid-19 Vaccine

Pfizer Inc. and BioNTech SE have asked U.S. health regulators to clear use of a Covid-19 shot modified to target the newest versions of the Omicron variant. The U.S. Food and Drug Administration is expected to clear the shots for use in the coming weeks, in time for a planned fall booster campaign. The Pfizer-BioNTech booster shot targets the original coronavirus plus the BA.4 and BA.5 subvariants of Omicron, which have become predominant in the U.S. Pfizer and BioNTech said they have begun producing doses of the vaccines, and could begin supplying them to the U.S. government upon FDA clearance for a vaccination campaign that could start as soon as September.
23rd Aug 2022 - The Wall Street Journal

Anthony Fauci to Step Down After More Than 50 Years of Government Service

Anthony Fauci, President Biden’s chief medical adviser and the government’s top infectious-disease official, said he would step down in December. His plans to depart come as vaccines and other precautionary measures have helped protect many people from the worst possible outcomes of Covid-19 infection, but the virus’s ever-changing mutations, combined with many people’s fatigue with shots, complicate efforts to move past the pandemic. His departure portends changes at the helm of the country’s pandemic efforts as the Biden administration recalibrates to reflect the public’s changing sentiments, while preparing a campaign for the fall to boost people’s immune defenses against the latest, evasive versions of the virus. “As he leaves his position in the U.S. government, I know the American people and the entire world will continue to benefit from Dr. Fauci’s expertise in whatever he does next. Whether you’ve met him personally or not, he has touched all Americans’ lives with his work,” Mr. Biden said Monday.
23rd Aug 2022 - The Wall Street Journal

How Small Businesses Tapped Billions in Covid Relief

Policy changes to the Paycheck Protection Program, one of the largest in US history, redirected loans to the neediest communities. An analysis of 2020 and 2021 lending data shows what happened.
23rd Aug 2022 - Bloomberg

Serious health events rare in children after COVID-19 vaccine booster, says CDC study

In the present study, researchers used data from the vaccine adverse event reporting system (VAERS) and v-safe, a voluntary smartphone-based safety surveillance system, to analyze the effect of booster doses of BNT162b2 in US children aged five to 11 years between May 17 and July 31, 2022. The v-safe platform allows parents and guardians of all children under 15 years to report receipt of all doses of a COVID-19 vaccine and all other relevant information. The CDC staff at v-safe call centers encourage parents/guardians seeking medical care after COVID-19 vaccination to complete a VAERS report. VAERS, a passive vaccine safety surveillance system in the US, is co-managed by the CDC and FDA. VAERS documents all adverse events after COVID-19 vaccination reported by health care providers, vaccine manufacturers, and the public.
22nd Aug 2022 - News Medical

WHO recommends Valneva’s COVID-19 vaccine for those aged between 18 to 50 years old

The World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) has recommended Valneva's COVID-19 vaccine – VLA2001 for all individuals aged 18 to 50 years old. The vaccine is not recommended for people aged 50 years and avoid, due to limited data on the immunogenicity of the vaccine in this age group. Similarly, there is no data on efficacy or safety for people below the age of 18 years, and vaccination of this age group is therefore not currently recommended. VLA2001 is a purified, inactivated and adjuvanted whole virus SARS-CoV-2 vaccine, employing a similar approach to the flu vaccine.
22nd Aug 2022 - PMLiVE

The impact of the Covid vaccine on periods, from increased cramps to pattern disturbances

The UK has become the first country to approve a dual vaccine, which will tackle both the Omicron variant and the original Covid-19 virus, for use in the autumn. Described as “a sharpened tool in our armoury as the virus continues to evolve” by Dr June Raine, chief executive of the UK’s Medicines and Healthcare Products Regulatory Agency, the jab will be offered to the over-50s, health workers, carers over 16, those at clinical risk from the age of five upwards, and those who live with someone with a low immune system. Currently, there has been no announcement of when or if the dual roll-out will be expanded, but if it were, would everyone take another jab? Although we know immunity wanes over time, after 33 million people have had three vaccinations, and millions already had a likely Covid infection (there have been a recorded total of 19 million positive tests), should we anticipate greater apathy, or even hesitancy for those who experienced short-term side effects and think they can avoid them? The NHS says side effects can include a sore arm, feeling tired, headaches, feeling achy, feeling or being sick. You may also get a high temperature. Although these do not impact everyone, and should not last longer than a week. There have also been reports of changes to women’s menstrual cycles: heavy bleeding, increased cramps and disturbance to patterns.
22nd Aug 2022 - iNews

Scientists hope nasal vaccines will help halt Covid transmission

People who receive a Covid booster dose in the UK next month will be among the first in the world to receive Moderna’s dual-variant vaccine, which protects against two strains of the virus. But scientists say there is a misconception that this latest vaccine is an upgrade on what has come before. The evolution of the Covid virus to be more transmissible and better evade immunity is outpacing even innovative mRNA vaccines such as Moderna’s. The current generation of vaccines remain essential to protect us against severe illness and death. But when it comes to controlling infection, we are in a situation equivalent to running at a steady speed on a treadmill that is accelerating. Now leading scientists are calling for a renewed focus on nasal vaccines, delivered through a spray up the nose rather than an injection. They say nasal vaccines have the best chance of being able to halt Covid transmission and bring infections down to a manageable level.
22nd Aug 2022 - The Guardian

Amid covid surge, Iran approved coronavirus vaccine despite warnings over test results

As Iranian regulators considered endorsing a locally developed coronavirus vaccine a year ago, a top health official issued a stern warning, saying the test results were insufficient and the vaccine’s approval could undermine efforts to contain the country’s raging epidemic. Deputy Health Minister Farid Najafi wrote to his boss that allowing use of the vaccine by the general public before it met scientific standards “is a serious and historic decision that will determine the future of public confidence in the health system.” But the vaccine had influential backers. It was the highly touted project of a company called Barkat, part of a sprawling corporate empire close to Iran’s supreme leader, Ayatollah Ali Khamenei.
22nd Aug 2022 - The Washington Post

Spear Bio’s NAB-Sure™ Test Kit Aids Analysis of COVID-19 Immune Response

Pharmaceutical drug developers and healthcare researchers need innovative tools to understand COVID-19 immune response and validate vaccines and therapeutics critical to managing the pandemic. The newest development in assay technology, the NAB-Sure™ SARS-CoV-2 Neutralizing Antibody Test Kit from Spear Bio, is one such tool. Developed by former Harvard University scientists based at the Wyss Institute for Biologically Inspired Engineering, the NAB-Sure™ SARS-CoV-2 test kit provides a surrogate virus neutralization assay with much higher sensitivity than standard ELISA test formats and cell-based approaches
22nd Aug 2022 - The Associated Press

Long COVID-19 study identifies novel blood markers as potential diagnostic and therapeutic targets

World first study utilizing Somalogic SomaScan® assay# to assess up to 7,000 plasma proteins in Long COVID-19 patients has elucidated novel blood markers as potential diagnostic and therapeutic targets. Provisional patent applications have been filed in the United States (US) to seek protection for these new inventions A potential therapeutic marker known to be modulated by ATL1102 in DMD patients has been identified as suggestive of its therapeutic potential as a treatment for Long COVID-19. Collaboration with global leader in the clinical research of neurological aspects of Long COVID-19 Dr Koralnik to continue with application for grant funding
22nd Aug 2022 - The Associated Press

Pfizer told by FDA to test additional Paxlovid course in patients with COVID-19 rebound

Pfizer has been told by the US Food and Drug Administration (FDA) to test the effects of an additional course of Paxlovid (nirmatrelvir and ritonavir tablets) among individuals who experience a rebound in COVID-19 after the first course of treatment. The company must produce the initial results of a randomised controlled trial of a second course of the antiviral by 30 September next year, according to a letter from the regulator. The order follows reports of rebounding COVID-19 symptoms after the first course of treatment, which Pfizer said were rare. The FDA said a protocol for the study is expected to be finalised this month.
22nd Aug 2022 - PMLiVE

FDA: Novavax Covid-19 Vaccine Is Now Authorized For Ages 12 To 17

Teenagers will now have another option when it comes to getting vaccinated against Covid-19. And this new option is good because it is in many ways old. On August 19, the U.S. Food and Drug Administration (FDA) sent a letter to Novavax, Inc. This wasn’t a “hi, how you doing’” letter. Instead, this letter indicated that the FDA had agreed to modify the Emergency Use Authorization (EUA) for the Novavax Covid-19 adjuvanted vaccine to include those 12 through 17 years of age as well.
22nd Aug 2022 - Forbes

Neurological and psychotic disorders remain 2 years after infection with COVID-19

Both neurological and psychotic disorders have been found to persist in some patients 2 years after first becoming infected with COVID-19. The risk of some neurological and psychotic disorders remain elevated two years after infection with COVID-19 compared to other respiratory viruses according to the findings of a retrospective analysis by researchers from Oxford and Cambridge universities, UK. Whilst it has become widely recognised that infection with COVID-19 leads to substantial neurological and psychiatric morbidity in the 6 months after infection, it remains uncertain whether these risks decrease over time. Clearly, it is important to fulfil this evidence gap to provide reassurance to patients experiencing such adverse effects and to inform on future health policy service provision. It is also necessary to understand if there are differences in the risk profile among adults and children and finally if these risk profiles differ between COVID-19 variants.
22nd Aug 2022 - Hospital Healthcare Europe

What is the prevalence of bacterial co-infections during COVID-19?

The current work found bacterial pathogens, like Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Moraxella catarrhalis, and Klebsiella pneumoniae, among 31.9% of participants, including 32% in COVID-19-positive patients and 31% across COVID-19-negative patients. The scientists discovered no substantial variations in the bacterial infection rates across SARS-CoV-2-positive and negative cohorts. Besides, while the present bacterial co-infection incidence may be greater than those anticipated from many investigations, it was common in the literature for research using nasopharyngeal swabs to find elevated rates of bacteria than those depending on other sources like sputum.
22nd Aug 2022 - News-Medical.Net

Roche launches COVID-19 test to detect emerging variant of interest

Roche and its subsidiary TIB Molbiol have developed a COVID-19 test for researchers that detects and differentiates the latest sub-variant of interest BA.2.75. The test specifically targets two of the known unique mutations in BA.2.75, which allows clear differentiation against other notable subvariants. Roche is pleased to have developed a test for researchers that provides insights into the epidemiology of BA.2.75, helping to understand its impact on public health,” said Cindy Perettie, head of molecular labs at Roche Diagnostics Solutions.
22nd Aug 2022 - Labiotech.eu

EMA evaluating Skycovion COVID-19 vaccine

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Aug 2022

View this newsletter in full

Chinese city swabs freshly caught seafood for Covid-19

The Chinese coastal city of Xiamen is testing freshly caught fish, crabs and even shrimp for Covid-19 as it goes all out to contain a spiraling outbreak -- a policy drawing ridicule online and criticism from experts who say it's a "waste of resources." This week, videos of hazmat-suited health workers sticking cotton swabs into the mouths of fish and crabs went viral on Chinese social media, sparking complaints that the country's zero-Covid policy had gone too far. Since the pandemic, China has relied on mass testing, extensive quarantines and snap lockdowns to stamp out any resurgence of the coronavirus.
20th Aug 2022 - CNN

Is Thailand’s booster program losing race against fast-mutating COVID?

Thanks to constant mutations, the COVID-19 virus is still several steps ahead of vaccine developers. While researchers have managed to develop vaccines that are effective against the original strain of the new coronavirus and major variants like Delta, global mass vaccination efforts have failed to halt the raging pandemic. This is because the virus continues to evolve, spawning new mutations that evade the defences of currently available vaccines. As a result, the global infection rate remains at nearly one million confirmed COVID-19 cases per day, with thousands of deaths. Since the pandemic began, COVID-19 has claimed some 6.45 million lives across the world.
20th Aug 2022 - ThaiPBS World

Serious adverse events rare after COVID-19 boosters in young kids

Data collected from two vaccine safety surveillance programs in the first 10 weeks of administration of third doses of the Pfizer/BioNTech COVID-19 to US children aged 5 to 11 years show that serious adverse events were rare. A related study in South Korea shows waning vaccine effectiveness (VE) in adolescents after two and three Pfizer doses but sufficient protection against critical illness. Most side effects mild. In the first study, published today in Morbidity and Mortality Weekly Report, researchers from the Centers for Disease Control and Prevention (CDC) analyzed adverse-event data from the agency's voluntary smart phone-based v-safe vaccine-monitoring program and the Vaccine Adverse Event Reporting System (VAERS) from May 17 to Jul 31, 2022. VAERS is a passive vaccine surveillance system managed by the CDC and the Food and Drug Administration (FDA).
19th Aug 2022 - CIDRAP

CureVac announces start of phase 1 trial of modified COVID-19 mRNA vaccine candidate

German-based mRNA company CureVac has announced the start of a phase 1 study of its modified COVID-19 mRNA vaccine candidate – CV0501 – administered as a booster dose to previous vaccination. Developed in collaboration with GSK, CV0501 is based on CureVac’s ‘second-generation mRNA backbone’ specifically designed to protect against the Omicron variant. Set to be conducted at clinical sites in the UK, the US, Australia and the Philippines, the dose-escalation study will enrol up to 180 healthy, COVID-19-vaccinated adults to evaluate the safety, reactogenicity and immunogenicity of a single booster dose of CV0501 in the dose range of 12μg to 50μg.
19th Aug 2022 - PMLiVE

Covid-19: Results from India's 12 molnupiravir clinical trials remain unpublished

The results of 12 clinical trials conducted in India looking at the efficacy of molnupiravir —an antiviral drug for covid-19—have not been published a year after completion, researchers have said. Researchers from St George’s, Imperial College London, and the University of Liverpool looked at the availability of data from these trials as of July 2022 for a study released as a preprint.1 They found that, while some details of the findings had been revealed through press releases or conference abstracts, none of the results had been published in a journal or preprint service. This equates to missing data for 13 694 trial participants. “Patient level data would help answer many of the unanswered questions around the molnupiravir trials; however, even summary data are largely absent,” the authors wrote. In particular, questions remain over the efficacy of the drug. In October 2021, the MOVe-OUT trial first reported that it halved the risk of hospital admission or death by 50%, but when the full results were published in December 2021 they showed that hospital admissions and deaths were only around 30% lower in the molnupiravir group.
19th Aug 2022 - The BMJ

WHO recommends Valneva's COVID vaccine

The World Health Organization (WHO) on Thursday recommended the use of French drugmaker Valneva's COVID-19 vaccine. The UN agency also recommended the use of a second booster dose for some individuals at high risk of severe disease. However, that does not constitute a general recommendation of vaccinating all adults, and is aimed at avoiding severe disease and death in populations at the highest risk, it said.
19th Aug 2022 - Reuters

Canada OKs Pfizer COVID booster for kids 5-11, sees monkeypox cases slow

Canada's health ministry on Friday said it had authorized the use of Pfizer Inc's and BioNTech's COVID-19 vaccine as a booster for children five to 11 years old at least six months after receiving their initial two doses. The authorization for a booster shot was granted after a thorough, independent review of the vaccine, which "provides good protection against severe illness, hospitalization and death," the health ministry wrote on Twitter.
19th Aug 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Aug 2022

View this newsletter in full

Nuvaxovid gets expanded provisional approval in NZ as COVID-19 booster for adults

US-based Novavax has announced that New Zealand (NZ)'s Medsafe has granted expanded provisional approval for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent COVID-19 as a heterologous and homologous booster dose in adults aged 18 and older. Following the expanded provisional approval decision by Medsafe, New Zealand, people may now choose Nuvaxovid as their first and/or second COVID-19 booster dose(s) after completion of their primary series using any of the authorized COVID-19 vaccines. The request for expanded provisional approval for the booster dose is supported by data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As a booster for adults, Nuvaxovid is also provisionally registered in Australia and approved in Japan, and is actively under review in other markets. New Zealand previously granted provisional approval for Nuvaxovid in adults aged 18 and older in February 2022. Novavax' sponsor in Australia and New Zealand is Biocelect Pty. Ltd.
18th Aug 2022 - BioSpectrum Asia

Moderna Names New CFO After Hasty Departure of Predecessor

Moderna Inc. named a new finance chief roughly three months after the Covid-19 vaccine maker’s previous hire for the role departed abruptly due to an internal investigation under way at a prior employer. The Cambridge, Mass.-based biotechnology company on Wednesday said James Mock will start as its chief financial officer, effective Sept. 6, and David Meline, who has been filling in as CFO, will retire on the same day. Mr. Meline, who had served as CFO since 2020 and was called back in May, will remain at the company as a consultant to help with the transition, Moderna said. Mr. Mock has led since 2018 the finances of PerkinElmer Inc., a scientific instruments maker headquartered in Waltham, Mass. Before that, he held various finance roles at General Electric Co. over the course of nearly two decades, including vice president of corporate audit staff and CFO of a GE Aviation division, according to his LinkedIn profile.
18th Aug 2022 - The Wall Street Journal

Covid's Harmful Effects on the Brain Reverberate Years Later

Covid-19 survivors remain at higher risk of psychotic disorders, dementia and similar conditions for at least two years, according to a large study that highlights the mounting burden of chronic illness left in the pandemic’s wake. While anxiety and depression occur more frequently after Covid than other respiratory infections, the risk typically subsides within two months, researchers at the University of Oxford found. In contrast, cognitive deficits known colloquially as “brain fog,” epilepsy, seizures and other longer-term mental and brain health disorders remained elevated 24 months later, according to a study published Wednesday in the journal Lancet Psychiatry.
18th Aug 2022 - Bloomberg

AstraZeneca Hits Another Covid Hurdle in Slow Evusheld Rollout

Well over a year after the rollout of Covid-19 vaccines allowed most people to return to life as usual, Mark Oakley is still hiding away in a summer house in his garden, avoiding contact with even his closest family members. He’s had five vaccine doses, but the protective effect has been suppressed by medication he’s taking to tame a lung disorder. He thinks his predicament could be helped with Evusheld, an AstraZeneca Plc drug that protects vulnerable people from Covid by injecting them with two antibodies, but he can’t get hold of it.
18th Aug 2022 - Bloomberg

‘Covid patients at greater risk of psychiatric conditions up to two years later’

People with Covid-19 continue to face increased risk of developing neurological and psychiatric conditions like psychosis, dementia and brain fog two years after infection, new research suggests. There is also an increased risk of anxiety and depression in adults, but this subsides within two months of infection and, over two years, is no more likely than after other respiratory infections. The study of some 1.25 million people diagnosed with coronavirus found that children were more likely to be diagnosed with some conditions, like seizures and psychotic disorders. However, the likelihood of most diagnoses after Covid was lower than in adults.
18th Aug 2022 - Yahoo News UK

Study links reduced myocardial blood flow and COVID-19

Patients with prior COVID may be twice as likely to have unhealthy endothelial cells that line the inside of the heart and blood vessels, according to newly published research from Houston Methodist. This finding offers a new clue in understanding covid-19's impact on cardiovascular health. In a new study published today in JACC: Cardiovascular Imaging, Houston Methodist researchers examined the coronary microvasculature health of 393 patients with prior covid-19 infection who had lingering symptoms. This is the first published study linking reduced blood flow in the body and COVID-19. Using a widely available imaging tool, called positron emission tomography (PET), researchers found a 20% decrease in the ability of coronary arteries to dilate, a condition known as microvascular dysfunction.
18th Aug 2022 - News Medical

Time to Stop Using Ineffective Covid-19 Drugs

In this issue of the Journal, Bramante et al.6 report the results of the COVID-OUT randomized, controlled trial of oral metformin, ivermectin, and fluvoxamine for the early treatment of SARS-CoV-2 infection in 1323 outpatients. The investigators found no reductions in hypoxemia, emergency department visits, hospitalization, or death associated with any of the three drugs. A strength of the trial is the selection of adults between the ages of 30 and 85 years who were at high risk for severe Covid-19 because of overweight or obesity. However, as a result, the trial may not be readily generalizable to patients at lower risk for severe disease. One secondary analysis, which should be interpreted with caution, suggested that metformin may reduce a composite of emergency department visit, hospitalization, or death in this population with overweight or obesity, a finding that indicates no more than the need for further investigation at this time.
18th Aug 2022 - nejm.org

Covid linked to longer-term elevated risk of brain fog and dementia

Millions of people who have had Covid-19 still face a higher risk of neurological and psychiatric conditions, including brain fog, dementia and psychosis, two years after their illness, compared with those who have had other respiratory infections, according to the single largest study of its kind. They also face an increased risk of anxiety and depression, the research suggests, but this subsides within two months of having Covid-19. Over two years the risk is no more likely than after other respiratory infections. The findings are published in the Lancet Psychiatry journal. Almost 600m Covid-19 cases have been recorded worldwide since the start of the pandemic, and there has been growing evidence that people who survive the disease face increased risks of neurological and psychiatric conditions.
18th Aug 2022 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Aug 2022

View this newsletter in full

Another tantalizing step closer to a universal flu vaccine

Most circulating in birds are also influenza A viruses, and no one knows if—or when—one of them will jump the species barrier. Developing a universal vaccine that targets A strains of flu viruses would be a scientific godsend, global health experts say. "Influenza A viruses present major public health threats," writes Dr. Jaekeun Park of the Viral Pathogenesis and Evolution section of the National Institutes of Allergy and Infectious Diseases.
18th Aug 2022 - Medical Xpress

Regulators in Britain approve new COVID-19 vaccine booster

Regulators in Britain are the first in the world to approve a COVID-19 vaccine booster that targets two coronavirus variants. Tina Kraus reports for CBS2.
17th Aug 2022 - CBS News

JCVI publishes advice on COVID-19 vaccines ahead of autumn booster campaign

The Joint Committee on Vaccination and Immunisation (JCVI) has published its advice on which COVID-19 vaccines should be used in this year’s autumn booster programme. For adults aged 18 years and above, the JCVI’s advised vaccines include Moderna’s mRNA (Spikevax) bivalent Omicron BA.1/original wild-type vaccine, as well as its mRNA (Spikevax) original wild-type vaccine. The Pfizer/BioNTech mRNA (Comirnaty) original wild-type vaccine is also advised, and in exceptional circumstances, the Novavax Matrix-M adjuvanted wild-type vaccine (Nuvaxovid) when ‘no alternative clinically suitable UK-approved COVID-19 vaccine is available,’ the JCVI stated. The Pfizer/BioNTech mRNA (Comirnaty) original wild-type vaccine is the only vaccine the JCVI advises for people aged 12 to 17 years, and its paediatric formulation is the only advised for those aged five to 11 years old.
17th Aug 2022 - PMLiVE

BCG vaccine can protect against Covid, new report finds

The world may have another tool with which to fight the effects of the Covid-19 virus. A new study published in Cell Medicine Reports has found that the Bacillus-Calmette-Guerin (BCG) vaccine, developed to help fight tuberculosis in the early 1900s, may offer a measure of protection against Covid and a range of other infectious diseases and bacteria by strengthening the immune system. The study in question began before the first Covid outbreak in the United States, back in January 2020. It was designed to see whether BCG vaccinations could help people with Type 1 diabetes resist infections – including, ultimately, Covid.
17th Aug 2022 - The Independent

Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Provisional Approval in New Zealand as a First and Second Booster for Adults

Following the expanded provisional approval decision by Medsafe, New Zealand, people may now choose Nuvaxovid as their first and/or second COVID-19 booster dose(s) after completion of their primary series using any of the authorized COVID-19 vaccines. “We are pleased to offer another booster choice and the only protein-based COVID-19 vaccine for those aged 18 and older in New Zealand,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “As New Zealand endures winter months where thousands of COVID-19 infections are being recorded each day, we believe our vaccine is a strong option, particularly given its broad immune responses to a wide range of circulating variants.”
17th Aug 2022 - The Associated Press

Novavax asks FDA for emergency authorization of its COVID-19 booster

Novavax has submitted an application to the Food and Drug Administration for Emergency Use Authorization of its COVID-19 vaccine as a booster in adults that can be used on top of its primary vaccine series or to mix and match with a different primary series, the company announced. "It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations," Stanley C. Erck, President and Chief Executive Officer of Novavax, said in a statement on Monday. "Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants," Erck said.
17th Aug 2022 - ABC on MSN.com

Nearly 14 mn US kids infected with Covid-19 since onset of pandemic

Nearly 14 million children in the US have tested positive for Covid-19 since the onset of the pandemic in early 2020, according to the latest report by the American Academy of Pediatrics (AAP) and the Children's Hospital Association. Almost 371,000 of these cases have been added in the past four weeks, Xinhua news agency quoted the report as saying. Approximately 6.4 million reported cases have been added in 2022, it said. For the week ending August 11, almost 87,000 child Covid cases were reported. There is an urgent need to collect more age-specific data to assess the severity of illness related to new variants as well as potential longer-term effects, said the AAP.
17th Aug 2022 - Business Standard

Hypertension remains a significant risk factor for severe COVID-19 in fully vaccinated

The presence of hypertension still poses a significant risk factor for more severe disease in COVID-19, even among those fully vaccinated. Patients with hypertension even after receipt of three COVID-19 vaccination doses, remain at an elevated risk of severe breakthrough infections with the Omicron variant according to researchers from the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, US. Although full vaccination against COVID-19 initially required individuals to have two doses, the fact that immunity appears to wane over time has led to a recommendation for a third dose. In fact, a third dose appears to provide greater protection with data showing how a third dose of the BNT162b2 vaccine administered a median of 10.8 months after the second dose provided 95.3% efficacy against COVID-19 compared with two doses.
17th Aug 2022 - Hospital Healthcare Europe

When COVID-19 or flu viruses kill, they often have an accomplice – bacterial infections

The 1918 influenza pandemic resulted in the loss of over 3% of the world’s population – at least 50 million people. But it wasn’t the flu virus that caused the majority of these deaths. An analysis of lung samples collected during that flu pandemic indicated that most of the deaths were likely due to bacterial pneumonia, which ran rampant in the absence of antibiotics. Even in more recent history, like the 1957 H2N2 and 2009 H1N1 flu pandemics, nearly 18% of patients with viral pneumonia had additional bacterial infections that increased their risk of death. And the COVID-19 pandemic is no different.
17th Aug 2022 - The Conversation

Higher risk of vein blood clots in COVID vs flu patients

Hospitalized adult COVID-19 patients before and after SARS-CoV-2 vaccine availability had significantly higher odds of venous—but not arterial—thromboembolism than those hospitalized for influenza before the pandemic, finds a study published today in JAMA. A team led by University of Pennsylvania researchers retrospectively studied rates of venous thromboembolism (blood clot in a vein) and arterial thromboembolism (blood clot in an artery) in 41,443 COVID-19 patients hospitalized before the vaccine rollout (April to November 2020), 44,194 COVID-19 patients admitted after vaccines became available (December 2020 to May 2021), and 8,269 patients hospitalized with the flu from October 2018 to April 2019. Thromboembolism can cause blockage of a blood vessel and thus can be severe.
16th Aug 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Aug 2022

View this newsletter in full

What, Exactly, Is 'Paxlovid Mouth,' and How Do You Get Rid of It?

The 56-year-old in Montclair, N.J., was looking for a reprieve from a persistent residual taste—“like your mouth is just clenched around a grapefruit rind”—that came after she took Paxlovid, Pfizer’s antiviral drug to treat Covid-19. Ms. Witten is one of many people who have scouted remedies for what is informally known as Paxlovid mouth, a taste that can linger for as long as you take the drug. Patients who have taken Paxlovid have described it as sun-baked trash-bag liquid, a mouthful of dirty pennies and rotten soymilk. They have tried to erase the taste with salves from cinnamon to milk to pineapple. They are also trading strategies online. A Pfizer spokesperson acknowledged the side effect, called dysgeusia, and pointed to a study that found the symptom occurred 5.6% of the time people took the drug. The study was funded by Pfizer and published in the New England Journal of Medicine. The company said most patients’ dysgeusia symptoms were mild.
17th Aug 2022 - The Wall Street Journal

Artificial intelligence can explain why each COVID-19 wave impacts our bodies differently

Researchers have identified what they believe to be robust metabolic markers of Covid, a discovery which could lead to better understanding and treatments for people that suffer from symptoms of the disease months after diagnosis. Scientists from the University of Surrey collected blood samples of hospital patients and found that Covid-19 changed people's metabolism. The team observed that the effects of Covid-19 changed over time, with the first wave disrupting metabolites differently from the second.
16th Aug 2022 - Science Daily

Bharat Biotech says Phase 3 trial over, intranasal vaccine safe

Bharat Biotech has submitted data from Phase 3 clinical trials of BBV154, its intranasal Covid vaccine candidate, to the drug regulator. It has sought approval both as a primary two-dose vaccine, and a heterologous booster shot. A heterologous booster implies that the third or subsequent dose of the vaccine is different from its primary dose. Typically, the primary dose comprises two shots. The Hyderabad-based company claimed that BBV154, which is stable at 2-8 degrees Celsius, is proven to be safe, well-tolerated and immunogenic in the subjects under controlled clinical trials. “Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract. These may provide the potential to reduce infection and transmission. Further studies are being planned,” the company noted on Monday.
16th Aug 2022 - Business Standard

From nasal vaccines to pills: the next defences against Covid

When the autumn booster programme begins next month, many people are likely to receive Moderna’s new bivalent vaccine, designed to protect against the original Covid strain and the more transmissible Omicron variant. As Covid continues to evolve, so will vaccination strategies. Here we look at some of the developments in the pipeline.
16th Aug 2022 - The Guardian

Covid-19: Southampton vaccine trial calls for pregnant women

A national Covid-19 vaccine trial is now calling for pregnant women from across the South. The study, taking place at University Hospital Southampton, will start to recruit participants later this month. It will look into the immune response to vaccination at different dose intervals - either four to six weeks or eight to 12 weeks. Participants will need to be between 18 and 44-years-old and 13 to 34 weeks pregnant on the day of vaccination. Women who have had previous vaccinations can still take part as the trial focuses on boosters, the size of the dose and which vaccine works best. The study, led by St George's, University of London, is backed by £7.5 million of government funding.
16th Aug 2022 - BBC News

Health DG: Paxlovid for high-risk Covid-19 patients, not for mild cases or prevention

The country’s policy on the usage of Covid-19 antiviral drug Paxlovid does not include low-risk, asymptomatic patients, says Health director-general Tan Sri Dr Noor Hisham Abdullah. The medication was also not for prevention of Covid-19, he said. The ministry’s policy on administration of Paxlovid for Covid-19 was in line with the intent to reduce hospitalisation and deaths, he said. "The Malaysian policy on the usage of Paxlovid has not included low risk patients who have no symptoms or usage for prevention of infection. "Paxlovid is an antiviral and thus has to be started early when the illness is still in the mild category. "The usage of Paxlovid is based on risk stratification from real Covid-19 patients’ data, who are determined as at high risk of deterioration.
16th Aug 2022 - The Star Online

How efficient is backward contact tracing in COVID-19?

Study finds COVID associated with abnormal placental pathologies in nearly 50% of cohort. The features of the newly emerging SARS-CoV-2 Omicron BA.2.75 subvariant. Inhaled aprotinin found to reduce viral load in mild-to-moderate COVID-19
16th Aug 2022 - News-Medical.Net

The hunt for a universal Covid-19 vaccine

In the mid 1980s, Jonathan Heeney was a PhD student at the US National Institutes of Health (NIH), Maryland, when he was told to fly to Oregon – on the opposite side of the country – to investigate a mysterious new disease which was causing a surge of sudden deaths in a group of captive cheetahs. For Heeney, it proved to be his first known encounter with a coronavirus. "We eventually determined that this was a coronavirus which had jumped from domestic cats into these cheetahs," he says. "And because cheetahs were a new host, it caused a lot of death and destruction. So that was my introduction to them." Four decades on and Heeney is at the helm of DIOSynVax, a biotechnology company based in Cambridge, UK, who recently received a $42m (£34m/€41m) grant from the Coalition for Epidemic Preparedness Innovations (CEPI), the foundation backed by Bill and Melinda Gates, the Indian and Norwegian governments, and the World Economic Forum, among others.
16th Aug 2022 - BBC News

'Next Generation' Moderna Coronavirus Booster Jab Approved for Use in Adults

A "next generation" coronavirus booster jab which may only need administering once a year has been approved for use in adults. The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Moderna's bivalent vaccine, which targets the original Covid strain and the Omicron variant.
15th Aug 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Aug 2022

View this newsletter in full

UK Approves First Bivalent COVID-19 Booster Vaccine

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on August 15, 2022 that it has approved a bivalent version of Moderna’s COVID-19 vaccine that targets both the original and Omicron strains of the virus. The decision follows an endorsement of the booster from the UK’s Commission on Human Medicines, the government’s independent scientific advisory board. According to an agency press release, the decision was based on a clinical trial which demonstrated that the booster triggers a strong immune response against the original COVID-19 strain and BA.1, the first Omicron strain. It also demonstrated a good immune response against Omicron sub-variants BA.4 and BA.5. Side-effects and overall safety profile were found to be the same as those in the original vaccine.
15th Aug 2022 - PharmTech

Lack of evidence for AstraZeneca's COVID-19 vaccine says UK Department of Health

The UK’s Department of Health and Social Care has decided not to buy AstraZeneca’s COVID-19 drug, Evusheld, due to a lack of evidence about the vaccine’s effectiveness against the Omicron variant. Evusheld – tixagevimab co-packaged with cilgavimab – is a preventative treatment that is given before people have been exposed to the virus. Patient groups and charities have called upon the government to reassess its position due to the potential impact the decision will have on clinically vulnerable people during the winter. Developed by AstraZeneca, Evusheld is a combination of two antibodies that work against COVID-19 by boosting protection for those with weakened immune systems, including those who are organ transplant recipients or blood cancer patients.
15th Aug 2022 - PMLiVE

Novavax seeks U.S. authorization for COVID vaccine booster

Novavax Inc said on Monday it had filed for U.S. authorization for use of its COVID-19 vaccine as a booster dose in people who had either received its shots or a different vaccine. The application to the U.S. Food and Drug Administration comes in the face of a slow rollout in the United States, where the Novavax vaccine was authorized in July, despite expectations that it would convince vaccine skeptics to get inoculated.
15th Aug 2022 - Reuters

Bharat Biotech seeks approval for intranasal coronavirus vaccine

U.K. Approves Moderna’s Covid-19 Vaccine Targeted at Omicron

The U.K. became the first country to approve Moderna Inc.’s Omicron-targeting Covid-19 vaccine as a booster shot, paving the way for the variant shot to play a role in a planned fall vaccination campaign to shore up immune defenses against the virus. The so-called bivalent vaccine is directed against both the original strain of SARS-CoV-2, the virus that causes Covid-19, and the first Omicron variant, also known as BA.1, which drove large waves of infection over the winter. “What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve,” June Raine, chief executive of Britain’s Medicines and Healthcare products Regulatory Agency, said Monday.
15th Aug 2022 - The Wall Street Journal

Saliva-based COVID-19 test approved by Health Canada could reduce discomfort of nasal swab

Early during the pandemic, Neil Saxvy's son Matthew broke his arm and had to go to the hospital. Because of COVID-19, he needed a PCR test, which meant an eye-watering swab high up in his nostrils. The young boy did not enjoy the experience. "Ever since then he's wanted nothing to do with the test," Saxvy said. It's made testing — which occurs pretty regularly for kids in school settings over the course of years-long pandemic — more of a hassle. But on Saturday, the entire Saxvy family, including wife Anita and daughter Leah, did a much less invasive PCR test in Toronto. This one involved spitting into a cup and feeding their saliva into a machine.
15th Aug 2022 - CBC.ca

Is COVID-19 more deadly for children than the flu?

Dr Norman Swan explains key findings in new studies about COVID-19 and its effects on children.
15th Aug 2022 - ABC News

BCG Vaccine for Tuberculosis Offers Covid-19 Protection, Study Suggests

A widely used tuberculosis vaccine protected people with Type 1 diabetes from Covid-19, according to a Massachusetts General Hospital study published Monday that further illustrates the potential immune-enhancing powers of the shot, called BCG. The vaccine, a weakened version of the tuberculosis bacterium that infects cows, is given more than 100 million times a year around the globe to infants, but it isn’t part of the standard vaccination program in the U.S. Doctors have long suspected it has additional effects beyond tuberculosis prevention. When the Covid-19 pandemic struck in early 2020, the Mass General team was already studying whether BCG could treat Type 1 diabetes by helping eliminate harmful immune cells that attack the pancreas.
15th Aug 2022 - The Wall Street Journal

Superior protection with 'mix-and-match' COVID-19 booster strategy

The coronavirus disease 2019 (COVID-19) pandemic was caused by the sudden global outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Since SARS-CoV-2 emerged at the end of 2019, scientists have worked relentlessly to develop several vaccines to reduce the transmission of SARS-CoV-2 and protect individuals from severe COVID-19. Recently, a rapid decline in the level of antibodies elicited by vaccination with messenger ribonucleic acid (mRNA) vaccines has been observed. In a new Jama Network Open study, researchers discuss the durability and immunogenicity of homologous and heterologous booster regimens with the Johnson & Johnson Ad26.COV2.S and Pfizer-BioNTech BNT162b2 vaccines.
15th Aug 2022 - News-Medical.Net

Novavax seeks U.S. authorization for COVID vaccine booster

Why is COVID-19 more severe in people older than 50?

The adaptive immune system mounts pathogen-specific humoral and cellular responses to combat infections. Upon identification of a new virus, B- and T-cells will elicit specific responses to the infection. A new PNAS journal study reports that the reduced efficiency of the immune response against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could be due to the reduced diversity of both B- and T-cells. This reduction in T-cell diversity was observed only in subjects over 50 years of age who are at an increased risk of coronavirus disease 2019 (COVID-19) morbidity and mortality.
15th Aug 2022 - News-Medical.Net

UK first to approve Omicron COVID shot with Moderna nod

Britain, the first country to approve a coronavirus vaccine in late 2020, has now also given the first green light to a variant-adapted shot that targets both the original and Omicron version of the virus. The UK medicines regulator (MHRA) gave the so-called bivalent vaccine made by U.S. drug company Moderna conditional approval as a booster for adults on Monday. Later on Monday, the UK's Joint Committee on Vaccination and Immunisation (JCVI) backed the use of the variant-adapted shot in the country's booster campaign starting September.
15th Aug 2022 - Reuters UK

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Aug 2022

View this newsletter in full

ONS data reveals significant decrease in COVID-19 antibodies

New figures from the Office for National Statistics (ONS) show the percentage of the UK population estimated to have COVID-19 antibodies is declining rapidly, prompting calls for the government to start its autumn booster vaccination campaigns as soon as possible. The latest ONS data revealed the estimated percentage of the population in England with an antibody level of at least 800ng/ml dropped from a peak of 82.4% in March 2022 to 71.9% by mid-July, a decline of 12.7%. The data was similar throughout the UK, with high antibody levels also declining in Scotland, Wales and Northern Ireland. Dr Quinton Fivelman, chief scientific officer at private testing company London Medical Laboratory, said: “This dramatic 12.7% decrease in the number of people in England with a significant number of antibodies to COVID-19 is obviously concerning.
12th Aug 2022 - PMLiVE

Ceapro and McMaster extend partnership to develop Covid-19 therapy

Ceapro has extended a partnership underway to carry out a further research project with McMaster University for developing an inhalable immuno-therapeutic/-prophylactic for Covid-19-induced lung fibrosis. This project is intended to develop therapies for people suffering from Covid-19’s long-term effects. In August 2019, the parties entered a partnership for new drug delivery system development leveraging the disruptive Pressurized Gas eXpanded Liquid technology (PGX) to streamline drug formulations utilised in areas with unmet medical needs. The PGX technology has so far shown the potential for purifying and drying yeast beta glucan (YBG) into uniform inhalable particles that are capable of modifying the immune system using a certain mechanism of action. The new development is aimed at streamlining PGX-YBG delivery to the lung and establishing the anti-fibrotic properties to lower reducing lung fibrosis, both alone and given along with an anti-inflammatory drug used presently for Covid-19.
12th Aug 2022 - Pharmaceutical Technology

Covid-19: Study provides further evidence that mRNA vaccines are safe in pregnancy

Pregnant women experienced lower rates of significant adverse events after vaccination with a covid-19 mRNA vaccine than a group of similarly aged women who were not pregnant, a Canadian study has concluded. The researchers found that 7.3% of pregnant women experienced health events requiring time off work or school or needing medical attention within a week of the second dose of an mRNA vaccine, which compared with 11.3% of vaccinated non-pregnant women. The study, published in Lancet Infectious Diseases, adds to the growing body of evidence that mRNA covid vaccines are safe during pregnancy. In January a US study of 46 079 pregnancies found that vaccination against SARS-CoV-2 was safe and did not increase the risk of preterm birth or of babies who were small for their gestational age. Vaccine uptake during pregnancy has increased over the course of the pandemic but rates are still below those in the general population
12th Aug 2022 - The BMJ

Long COVID risk up for unvaccinated children; at-home antibody test shows promise

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Unvaccinated children have higher long COVID risk A small study is adding to evidence that children can develop long COVID-19 even if the virus did not make them seriously ill. Researchers in Texas who tracked 1,813 children infected with the virus between October 2020 and May 2022 - during the waves of the Delta and Omicron coronavirus variants - found that 4.5% had symptoms for up to 12 weeks and 3.3% had symptoms for longer than 12 weeks
12th Aug 2022 - Reuters

Covid-19 Variants Keep Getting More Contagious. Here’s Why.

As the Omicron BA.5 subvariant is the latest to take over and dash the hopes of a summer Covid-19 lull, researchers have attempted to quantify and explain its edge over earlier versions of the virus. The BA.5 subvariant is estimated to be some 70% more transmissible than BA.2, which took over the landscape in the spring, said Trevor Bedford, a computational biologist at the Fred Hutchinson Cancer Center. That estimate is based on how quickly the BA.5 variant displaced its predecessor, he said. Comparing the BA.5 subvariant to earlier versions of the virus, such as Delta or even BA.1, however, is more of a challenge, Dr. Bedford and other infectious-disease experts said. Covid-19 vaccinations and infections have changed our immune defenses over time, making head-to-head matchups between past and present variants harder, including for characteristics like intrinsic severity of the disease.
12th Aug 2022 - The Wall Street Journal

COVID-19 neuro complications, long-term symptoms in kids

In a large, multicenter study published today in Pediatrics, a team led by Vanderbilt University researchers followed 15,137 COVID-19 patients aged 2 months to 17 years released from 52 US children's hospitals participating in the Pediatric Health Information System database from March 2020 to March 2022. Of the 15,137 patients, 82.1% had a primary COVID-19 diagnosis, and 17.9% had a secondary diagnosis of COVID-19 and a related complication. A total of 37.1% of children had a complex chronic condition (CCC), and 9.8% had at least one previously diagnosed neurologic CCC. Seven percent of patients developed a neurologic complication, the most common of which were fever-triggered seizures (3.9%), non–fever-related seizures (2.3%), and encephalopathy (brain damage or disease) (2.2%).
11th Aug 2022 - CIDRAP

Pregnant Women Safe to Get Covid mRNA Vaccines, Study Shows

Covid-19 vaccines using messenger RNA technology were safe in pregnancy according to a large Canadian survey, further building the case for pregnant women to get the shots. Vaccinated women who weren’t pregnant reported higher rates of potential side effects than pregnant women, surprising researchers. In the survey, 7.3% of pregnant women who got an mRNA-based Covid shot reported potential side effects within a week after their second dose, most commonly feeling unwell, having a headache or migraine or a respiratory tract infection. About 11% of respondents who weren’t pregnant made similar reports.
11th Aug 2022 - Bloomberg

Striking Drop in Stress Hormone Predicts Long Covid in Study

Striking decreases in the stress hormone cortisol were the strongest predictor for who develops long Covid in new research that identified several potential drivers of the lingering symptoms afflicting millions of survivors. Levels of cortisol in the blood of those with the so-called post Covid-19 condition were roughly half those found in healthy, uninfected people or individuals who fully recovered from the pandemic disease, researchers at Yale School of Medicine in Connecticut and the Icahn School of Medicine at Mount Sinai in New York found.
11th Aug 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Aug 2022

View this newsletter in full

CDC Drops Quarantine Recommendation After Covid-19 Exposure

Federal health officials scaled back guidance for quarantining and testing to screen for Covid-19 in settings including schools, a relaxation of pandemic precautions that reflects higher protection from vaccines, treatments and prior infection. The Centers for Disease Control and Prevention on Thursday said it no longer recommends that people quarantine after being exposed to the virus, as long as they don’t feel sick, get tested after five days and wear a high-quality mask around others for 10 days. People should still isolate from others for at least five days if they test positive, the CDC said.
11th Aug 2022 - The Wall Street Journal

U.S. CDC no longer recommends students quarantine for COVID-19 exposure

The U.S. Centers for Disease Control and Prevention will no longer recommend quarantines or test-to-stay programs at schools or daycare centers for people exposed to COVID-19, the agency said in updated guidelines on Thursday. The agency also said it was no longer recommending unvaccinated people quarantine after exposure as around 95% of the U.S. population has either been vaccinated, had COVID-19 already, or both.
11th Aug 2022 - Reuters

South Korea’s 1st domestic COVID-19 vaccine ready

Hundreds of vials were lined up on the belt of a packaging machine at L House, SK Bioscience’s vaccine manufacturing facility in Andong, North Gyeongsang Province on Wednesday afternoon, as the developer of South Korea’s first homegrown COVID-19 vaccine SKYCovione is poised to roll out the vaccine’s first batch by the end of August. A few researchers, who were covered from head to toe with sterilized gear — protective shoes, clothing and hair caps — oversaw the automatic process while others put finishing touches on the packages. On the surface of the packaged products, which were stacked one by one in a yellow plastic box, it read: “SKYCovione Multi-Inj.”
11th Aug 2022 - INQUIRER.net

Universal vaccine needed to tackle future Covid waves, study suggests

A universal Covid jab is “urgently needed,” scientists have warned after a study confirmed prior infection or vaccination offers only limited protection against new variants.
11th Aug 2022 - The Independent

Moderna CEO says Covid vaccines will evolve like 'an iPhone'

Forget taking two to three Covid shots a year. Moderna hopes to roll out a single-dose annual booster to cover the coronavirus, the flu and another common respiratory virus within the next five years. As Covid-19 continues to mutate, Moderna will need to keep updating the vaccines that turned it into a global household name while trying to make it more convenient for consumers, CEO Stéphane Bancel said in an interview with CNN Business Wednesday. He estimated a timeline of "three to five years" for the new combined product, and likened the development of the life-saving jab to that of a smartphone. "You don't get the amazing camera, amazing everything the first time you get an iPhone, but you get a lot of things," he said. "A lot of us buy a new iPhone every September, and you get new apps and you get refreshed apps. And that's exactly the same idea, which is you'll get Covid and flu and RSV [respiratory syncytial virus] in your single dose."
11th Aug 2022 - CNN

Does Covid Vaccine Protect Against Omicron? Scientists Seek Pan-Coronavirus Shot

Scientists fear the omicron shots coming this fall won’t be much better at keeping people from getting Covid-19 than what’s come before. That’s pushing drugmakers to start working on next-generation vaccines that don’t have to be updated that often, if at all. Testing shows that omicron-specific vaccines under development at Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE will be “little or no better” than the currently available boosters, according to John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. “The benefit of switching composition is barely detectable,” Moore said.
11th Aug 2022 - Bloomberg

COVID rebound is surprisingly common — even without Paxlovid

After the game-changing COVID-19 antiviral Paxlovid began to be used in late 2021, researchers noticed a perplexing trend. In some people taking the drug, symptoms and detectable virus vanish, only to mysteriously return days later. After months of grasping at straws, scientists are beginning to make some headway in understanding ‘Paxlovid rebound’. Two recent studies suggest that it is surprisingly common for SARS-CoV-2 to return in untreated cases of COVID-191, while hinting that the virus’s comeback is fiercer and more common in people who take Paxlovid
11th Aug 2022 - Nature.com

Ensovibep no better than placebo for hospitalised COVID-19 patients

A trial of a novel designed ankyrin repeat protein, ensovibep, for the treatment of patients hospitalised with COVID-19 proved no better than placebo. Ensovibep treatment for patients hospitalised with COVID-19 was no better than placebo and, in fact, the trial was terminated early because of futility, according to the findings of randomised trial by researchers from the ACTIV-3/TICO group. The early treatment of patients infected with COVID-19 using anti-virals such as molnupiravir reduces the risk of hospitalisation or death in at-risk, unvaccinated adults. However, to date, there are no effective anti-viral agents for those who have been hospitalised due to virus. One new class of treatment is designed ankyrin repeat proteins (DARPins), which represent a novel class of specific binding molecules, that can recognise targets with specificities and affinities that equal or surpass those of antibodies.
11th Aug 2022 - Hospital Healthcare Europe

COVID-19 infection in pregnant women linked to increased risk of adverse outcomes

COVID-19 infection in pregnant women is associated with increased risk of adverse outcomes compared to women who are not pregnant, according to a review published in JACC: Advances from the American College of Cardiology Cardiovascular Disease in Women Committee. Cardiovascular complications include heart attack, arrythmias, heart failure and long-haul symptoms that may be difficult to distinguish from other cardiac complications of pregnancy and require the cardiovascular care team to be vigilant when assessing pregnant women with COVID-19. As COVID-19 cases increased globally, awareness of cardiovascular complications also increased, especially in certain high-risk populations. Heart attacks is estimated in up to 12% of patients.
11th Aug 2022 - News-Medical.Net

Key blood clotting protein could be 'warning light' for COVID-19 cases

University of Aberdeen team suggest results indicate that protein PAI-1 could be an early indicator of severe COVID-19 A protein that could be an early indicator of severe COVID-19 has been identified by scientists at the University of Aberdeen. Patients who get seriously ill following a COVID-19 infection frequently show evidence of a severe form of lung disease and in around 30% of patients blood clots are evident. Blood clots arise due to deposits of fibrin within the lung contributing to pneumonia and respiratory distress. These fibrin deposits restrict the amount of oxygen absorbed into the lung.
11th Aug 2022 - PharmaTimes

Valneva cuts full-year outlook on lower COVID-19 vaccine sales

French vaccine developer Valneva on Thursday cut its full-year revenue outlook citing lower demand for its anti-COVID shot from European Union member states. The European Commission in July slashed its order for VLA2001 to just 1.25 million doses from a previously targeted 60 million, pointing to European countries being well supplied with other vaccines and a slowdown in vaccination programmes.
11th Aug 2022 - Reuters

Africa CDC hopeful Aspen will get COVID vaccine orders

Africa's top public health body said on Thursday it was hopeful South African pharmaceutical firm Aspen Pharmacare would get orders for its own brand COVID-19 vaccine. Africa Centers for Disease Control and Prevention (CDC) said last month that it is in detailed discussions with buyers to generate demand for Aspen's COVID-19 vaccine Aspenovax. Just one fifth of adults in Africa are fully vaccinated against COVID-19, but demand has fallen across the continent which already receives donated vaccines from Western countries and has supplies to hand from earlier purchases.
11th Aug 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Aug 2022

View this newsletter in full

UK health data collaboration paves the way to study long Covid symptoms

If the last two years have taught us anything, it’s that healthcare challenges transcend nations. As research teams across the world rapidly sought ways to collaborate and share information on Covid-19, a spotlight was shone on the importance of data in understanding viruses, diseases and other issues that affect people’s health and wellbeing. This complex, cooperative work allowed our colleagues to develop effective vaccines in record time, giving people the confidence to attend large events such as the Commonwealth Games that took place in Birmingham.
11th Aug 2022 - Pharmaceutical Technology

Queensland researchers find overlap in pathology of long COVID and chronic fatigue syndrome

Griffith University researchers say their findings could help to treat those suffering from long COVID. A woman with chronic fatigue syndrome says she suffered a relapse in symptoms after contracting COVID earlier this year. AMA Queensland says the findings should be independently verified and that more funding for such research should be made available
11th Aug 2022 - Australian Broadcasting Corporation

Vaccines are now approved for children aged six months to five years, but what about newborn babies?

COVID-19 vaccines are now approved for children aged from six months up to five years of age, and are already being rolled out to about 70,000 at-risk youngsters. But what about babies even younger than that? Will there be a vaccine for them? And what role does the vaccination of pregnant people play in the process? Children of all ages can get COVID-19 and experience its complications. However, as noted by an infectious diseases physician at Monash and Melbourne universities, Michelle Giles, young infants aren't at risk of the severe disease that has been seen with older Australians.
11th Aug 2022 - ABC News

Vaccine and drug development boosted by new CSIRO lab

Australia’s national science agency will open the doors of a new $23.1 million national vaccine and drug laboratory in Melbourne on Thursday, after six years of planning and delays. The CSIRO National Vaccine and Therapeutics Lab, based in the south-eastern Melbourne suburb of Clayton, is designed to help turn vaccine and drug candidates into products that can be manufactured onshore in large quantities for clinical trials and will be available for use by companies and researchers around the country.
11th Aug 2022 - Australian Financial Review

Science Is Still in a Race Against the Coronavirus

The Covid-19 pandemic has been a lesson in speed — the speed at which a novel virus among humans can spread, the speed at which it can rack up fatalities and cripple economies, the speed at which vaccines can be designed and produced, the speed at which misinformation can undermine public health. Amid all that rapidity is a different kind of speed, which drives the rest, like an engine spinning the cars on a nauseating carnival ride: the speed of viral evolution. The coronavirus, like many other viruses of its ilk (RNA viruses with highly changeable genomes), evolves fast. It has adapted quickly to us. Now arises the crucial question of whether humans and human ingenuity can adapt faster. Unless the answer is yes, we face a long, doleful future of continued suffering.
10th Aug 2022 - The New York Times

Pfizer readies 'robust' manufacturing capabilities to deliver 2 COVID-19 variant vaccines

Pfizer is planning to deliver COVID-19 vaccines against two sets of omicron subvariants in the autumn in the belief its “robust manufacturing capabilities” are up to the task.
10th Aug 2022 - BioPharma-Reporter.com

MIT researchers develop an easy-to-use test to predict Covid-19 immunity

Most people in the United States have some degree of immune protection against Covid-19, either from vaccination, infection, or a combination of the two. But, just how much protection does any individual person have? MIT researchers have now developed an easy-to-use test that may be able to answer that question. Their test, which uses the same type of "lateral flow" technology as most rapid antigen tests for Covid-19, measures the level of neutralizing antibodies that target the SARS-CoV-2 virus in a blood sample. Easy access to this kind of test could help people determine what kind of precautions they should take against Covid infection, such as getting an additional booster shot, the researchers say. They have filed for a patent on the technology and are now hoping to partner with a diagnostic company that could manufacture the devices and seek FDA approval.
10th Aug 2022 - News-Medical.Net

Covid-19 vaccination in pregnancy

Pregnancy is an independent risk factor for severe covid-19. Vaccination is the best way to reduce the risk for SARS-CoV-2 infection and limit its morbidity and mortality. The current recommendations from the World Health Organization, Centers for Disease Control and Prevention, and professional organizations are for pregnant, postpartum, and lactating women to receive covid-19 vaccination. Pregnancy specific considerations involve potential effects of vaccination on fetal development, placental transfer of antibodies, and safety of maternal vaccination. Although pregnancy was an exclusion criterion in initial clinical trials of covid-19 vaccines, observational data have been rapidly accumulating and thus far confirm that the benefits of vaccination outweigh the potential risks. This review examines the evidence supporting the effectiveness, immunogenicity, placental transfer, side effects, and perinatal outcomes of maternal covid-19 vaccination. Additionally, it describes factors associated with vaccine hesitancy in pregnancy. Overall, studies monitoring people who have received covid-19 vaccines during pregnancy have not identified any pregnancy specific safety concerns. Additional information on non-mRNA vaccines, vaccination early in pregnancy, and longer term outcomes in infants are needed. To collect this information, vaccination during pregnancy must be prioritized in vaccine research.
10th Aug 2022 - The BMJ

Novavax tumbles 30% as waning COVID-19 vaccine demand hits outlook

Shares of U.S. vaccine maker Novavax fell about 30% on Tuesday after it cut its annual revenue forecast by half over falling demand for its COVID-19 shot from low- and middle-income nations. Demand for its vaccine is also waning in the United States, where it was authorized for use among adults last month and was expected to be preferred by the skeptics of messenger RNA-based shots from Moderna Inc and Pfizer Inc
10th Aug 2022 - Reuters

S.Africa's Aspen to halt COVID vaccine output as J&J orders dry up

South Africa's Aspen Pharmacare will stop making COVID-19 vaccines from the end of this month due to a lack of orders, a senior executive said, further undermining Africa's already meager capacity to produce doses. Aspen currently produces vaccines for Johnson & Johnson. In March, it struck a deal to produce, price, and sell its own-brand version of the shot for African markets.
10th Aug 2022 - Reuters

Long-COVID treatments: why the world is still waiting

Bhasha Mewar has had it with doctors. Over the past two years, Mewar has spent nearly all of her life savings seeing heart and respiratory specialists, haematologists, urologists, dermatologists and more, in a desperate bid to tame her long-COVID symptoms. She has taken a slew of drugs: beta blockers to calm her racing heart, steroid inhalers to ease her laboured breathing and an antimalarial drug prescribed to her for reasons she never fully understood. And when Mewar — a curator at an art museum in Ahmedabad, India, who has been sick since what was probably a bout of COVID-19 in March 2020 — would visit her lung doctor twice a month, he always told her the same thing: you need to exercise. “I can’t even walk to the bathroom,” she would reply.
10th Aug 2022 - Nature.com

Covid symptoms sufferers still have four months after catching virus revealed

Covid sufferers are still reporting common symptoms an average of four months after having caught the virus, a new study has found. Two hundred patients enrolled in the Covid-19 Neurological and Molecular Prospective Cohort Study in Georgia, or CONGA, to investigate the longer term impacts of the illness. Fatigue and headache were the two symptoms most participants reported having some four months after first testing positive. Muscle aches, cough, changes in smell and taste, fever, chills and nasal congestion were the next most frequently cited symptoms.
10th Aug 2022 - The Independent

Immunity for common cold coronaviruses may ward off severe covid-19

People with a stronger immune response to the coronaviruses that cause common cold-like symptoms may be better protected against covid-19, raising hopes that a pan-coronavirus vaccine could be achieved. Ricardo da Silva Antunes at La Jolla Institute for Immunology in California and his colleagues analysed blood samples collected from 32 people between 2016 and 2019, before covid-19 emerged. Multiple samples were taken from each person over six months to three years. The team wanted to see how the immune cells in these samples responded to four coronaviruses that cause common cold-like symptoms as well as the original SARS-CoV-2 strain, which emerged in Wuhan, China, at the end of 2019.
10th Aug 2022 - New Scientists

Bat coronaviruses silently infect tens of thousands of people each year, posing pandemic risk, study warns

There may be an average of over 65,000 cases of bat coronaviruses silently infecting people every year in Southeast Asia, according to a new study that could lead to new tools for improving preparedness against future pandemics. The flying mammals are known to host coronaviruses that may be transmitted to people, including SARS-related coronaviruses. Previous studies have suggested that transmission of these viruses to humans may be relatively common in some parts of the world. However, human-bat interactions are also known to vary across regions, influenced by a variety of social, ecological, and economic factors at individual and community scales. The research, published on Tuesday in the journal Nature Communications, used a new framework to estimate and map the risk of potential SARS-related coronaviruses spreading from bats to humans in Southeast Asia.
10th Aug 2022 - The Independent

Study: Pfizer COVID vaccine efficacy wanes 27 days after dose 2 in teens

Article reports that a new study finds waning Pfizer/BioNTech COVID-19 vaccine protection against symptomatic infection in Brazilian and Scottish teens starting 27 days after the second dose amid the Delta and Omicron variant waves, but protection against severe illness was still strong at 98 days in Brazil. The study, published yesterday in The Lancet Infectious Diseases, analyzed nationwide data from 503,776 COVID-19 tests of 2,948,538 adolescents aged 12 to 17 years from Sep 2, 2021, to Apr 19, 2022, in Brazil, and 127,168 tests of 404,673 adolescents from Aug 6, 2021, to Apr 19, 2022, in Scotland. Protection against severe illness, defined as hospitalization or death within 28 days, was estimated only in Brazil owing to the small number of such cases in Scotland.
9th Aug 2022 - CIDRAP

Covid-19: What we know about the BA.4 and BA.5 omicron variants

The number of covid patients admitted to hospital rose steadily from around 550 a day at the end of May to more than 2200 in the second week of July. However, this has since begun to drop, to around 1700 in late July. Daily deaths with covid-19 recorded on the death certificate also rose from the beginning of June, from around 30 to a high of 134 in mid-July. The US Centers for Disease Control and Prevention reported on 22 July that cases, deaths, and hospital admissions were all rising, fuelled by BA.5, which accounted for an estimated 78% of cases. The seven day daily average of new hospital admissions was 6180 (13-19 July), a 4.7% increase from the previous week (5902).5 It has since started to drop. In China, reports suggest that the country is bracing for yet more lockdowns as the omicron subvariants continue to spread
9th Aug 2022 - BMJ.com

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Aug 2022

View this newsletter in full

Pfizer readies ‘robust’ manufacturing capabilities to deliver 2 COVID-19 variant vaccines

Pfizer is planning to deliver COVID-19 vaccines against two sets of omicron subvariants in the autumn in the belief its “robust manufacturing capabilities” are up to the task.
9th Aug 2022 - BioPharma-Reporter

Five Thoughts on the State of COVID-19 Vaccination and the Road Ahead

This is a confusing time in the public health emergency. Americans are thinking less about COVID-19 on a daily basis and many are eager to move on. But COVID-19 hasn’t gone away, as evidenced by quick spread of the new variant, and it will continue to be part of our lives for the foreseeable future. Getting more Americans vaccinated against the virus will help to move us out of the pandemic stage. We can do this by sharing the right message and using trusted messengers on multiple platforms. This is the focus of the AHA’s vaccine confidence initiative, supported by $3 million in grant funding from the Centers for Disease Control and Prevention (CDC). One of us is president of a hospital in North Carolina and has a background in family medicine and rural health. The other is chief marketing and experience officer for a health system in Louisiana. At the AHA Leadership Summit last month we offered our thoughts on the vaccine and the road ahead. Here are five highlights:
9th Aug 2022 - American Hospital Association

COVID in California: Vaccines, masks cut coronavirus transmission by 99.9% in classrooms, study finds

The alarming spread of omicron subvariants has again put a spotlight on how well COVID-19 rapid antigen tests work at this stage in the pandemic. Many ultra-wealthy people who left San Francisco in the early days of the pandemic decamped to ritzy ski towns. Coronavirus case rates and positive tests rates are steadily declining in California and the Bay Area, signaling that the region is finally on the downside of this summer’s record-long COVID-19 surge
9th Aug 2022 - San Francisco Chronicle

Study details post-COVID-19 symptoms and conditions among children and adolescents in the US

In a recent article published as part of the Morbidity and Mortality Weekly Report (MMWR), researchers assessed the incidence of post-coronavirus disease 2019 (COVID-19) symptoms and conditions among children and adolescents. The researchers found some previously unreported post-COVID conditions and symptoms, including acute pulmonary embolism, blood coagulation, hemorrhagic disorders, acute renal failure, venous thromboembolic event, and cardiac dysrhythmias, in the study participants.
9th Aug 2022 - News-Medical.Net

COVID-19 vaccination reduces infection-related myocardial infarction and stroke risk

COVID-19 vaccination significantly reduces the risk of both an acute myocardial infarction and stroke among those infected with the virus. COVID-19 vaccination provides individuals with a reduced risk of experiencing an acute myocardial infarction or ischaemic stroke after becoming infected with the virus according to the findings of a study by Korean researchers. It has now become recognised that following an acute infection with COVID-19, beyond the first 30 days, individuals with COVID-19 have an increased risk of cardiovascular disease and which includes cerebrovascular disorders, dysrhythmias, ischaemic and non-ischaemic heart disease, pericarditis, myocarditis, heart failure and thromboembolic disease. While it is clear that a COVID-19 vaccination is safe and offers protection against severe COVID-19, hospitalisation and death against all current variants of concern, what is less clear is whether vaccination is able to reduce the post-infection cardiovascular sequelae.
9th Aug 2022 - Hospital Healthcare Europe

With Innovation, We Can Keep Reducing the Toll of COVID-19

Scrolling through social media these days, you’ll see that loud extremists continue to dominate COVID-19 discourse. At one pole are the denialists who argue—incorrectly—that COVID is “just a cold.” At the other are those who suggest that no meaningful progress has been made in controlling its devastation. The truth, of course, is somewhere in the middle. We have not yet extricated ourselves from the peril of SARS-CoV-2, and wishing COVID-19 gone does not make it so. Surging case numbers provide opportunities to produce the next variant as the virus evolves to escape antibodies accumulated from vaccination and prior infection. (There is no way to predict the severity of disease caused by a future variant, though immunity undeniably helps.) Some portion of these cases will be severe, fatal, or result in disabling long COVID.
9th Aug 2022 - TIME

Covid-19: What we know about the BA.4 and BA.5 omicron variants

When and where were these subvariants detected? - BA.4 and BA.5 were first detected in South Africa in January and February 2022, respectively.1 They are offshoots of the omicron variant BA.2, though their additional mutations seem to have given them a transmission advantage. - What’s the difference between BA.4 and BA.5? - The World Health Organization has said that BA.5 now accounts for more than half of the world’s cases, while BA.4 accounts for just over one in 10.3 Why BA.5 has overtaken BA.4 is a mystery, because they’re so similar. Speaking at a Royal Society of Medicine event, Thomas Peacock, a virologist at Imperial College London, said, “They have identical spikes, more or less. So that means it has to be something outside the spike. And really our understanding of that from a virological perspective is very poor.”
9th Aug 2022 - The BMJ

The long reach of long Covid

A recent Kaiser Family Foundation report says that anywhere from 10 million to 35 million working-age adults — as many as a third of all infections — are experiencing long Covid, a hazily defined ailment with symptoms that can include “brain fog,” shortness of breath, heart palpitations and neurological changes. Those symptoms can last anywhere from a few weeks to more than a year. Sen. Tim Kaine (D-Va.) told POLITICO’s Alice Miranda Ollstein that he has felt “as if every nerve ending in my body has had five cups of coffee” since his initial infection subsided in early 2020.
9th Aug 2022 - Politico

EU regulator begins review of Pfizer-BioNTech's variant-adapted COVID shot

The European Medicines Agency (EMA) has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, it said on Tuesday. The so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID - the original strain first identified in China, and the Omicron offshoots BA.4/5 that are currently behind most cases in Europe. A rolling review means the EMA assesses the data as it becomes available, and the process continues until there is enough data for a formal marketing application.
9th Aug 2022 - Reuters

Novavax tumbles 31% as waning COVID vaccine demand hits revenue forecast

Covid Vaccine Maker Novavax Drops After Cutting Sales Outlook 50% (NVAX)

Novavax Inc. shares had their biggest loss in more than three years as the drugmaker slashed its 2022 revenue forecast late Monday on disappointing demand for its Covid-19 vaccine that trailed competitors getting to market. Sales for the year will be as much as $2.3 billion, less than half the previous expected peak of $5 billion, the company said in a statement. Novavax also reported a second-quarter loss of $6.53 a share, wider than analysts’ average estimate of $5.24.
9th Aug 2022 - Bloomberg

Loss Of Smell Linked To Long Term Covid Cognitive Impairment

The Argentinian research team investigated the long term Covid-19 cognitive impairment in older adults through a one-year prospective study design. All 766 participants were randomly invited from the health registry in Jujuy, Argentina, which holds all Covid-19 testing information for its region. Investigators split the group by polymerase chain reaction (PCR) testing status: 88.4% who had Covid-19 and 11.6% without—in other words, the control group.
9th Aug 2022 - Forbes

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Aug 2022

View this newsletter in full

Immunity for common cold coronaviruses may ward off severe covid-19

Study: COVID campus vaccine mandates saved lives. Are they still in place?

A new study of coronavirus vaccine mandates for students at U.S. colleges and universities suggests the mandates saved about 7,300 lives last fall. "I thought the study that came out (last month) was telling," said Daniel Hurley, CEO of the Michigan Association of State Universities, which represents all 15 public universities in Michigan. "Likely those policies, collectively, saved thousands of lives in this country ... When you put it in those terms, that's significant." A Free Press spot check showed that many Michigan colleges and universities plan to keep their vaccine policies in place for the new school year.
8th Aug 2022 - Detroit Free Press

EU regulator awaits trial data before decision on Covid jab targeting Omicron

The European drugs regulator is holding firm with plans to review Covid-19 vaccines designed to tackle the original coronavirus
8th Aug 2022 - Financial Times

BioNTech and Pfizer to begin clinical trial of vaccine for new Covid variants

BioNTech and Pfizer will start a clinical trial of a Covid-19 vaccine adapted to the BA.4 and BA.5 variants of Omicron this month
8th Aug 2022 - Financial Times

COVID-19 Vaccines Induce Better Long-Term Immunity than Infection

To answer these questions, Shane Crotty and his group at the La Jolla Institute for Immunology performed a head-to-head comparison of four currently used COVID-19 vaccines that target the SARS-CoV-2 spike protein: Pfizer/BioNtech (mRNA), Moderna (mRNA), Janssen/J&J (adenovirus), and Novavax (recombinant protein). In a six-month longitudinal study published in Cell, the researchers examined blood samples from vaccinated and recently infected people for SARS-CoV-2 spike-specific immune responses.
8th Aug 2022 - The Scientist

Covid becomes equal leading cause of death in New Zealand for first time

Covid-19 became the equal leading cause of death in New Zealand for the first time in July, overtaking stroke and drawing even with ischaemic heart disease as the country’s No 1 killer. Michael Baker, an epidemiologist and public health professor, said that for a period in July-August Covid appeared to be causing at least as many deaths as heart disease. Baker said that in mid-July, Covid deaths made up almost 15% of deaths overall, referring to data analysis by the New Zealand Herald that compared confirmed Covid deaths against overall deaths in July. Baker said those deaths were likely a slight undercount, as some people would have died of Covid-19 without being tested.
8th Aug 2022 - The Guardian

SyneuRx reveals results of COVID-19 candidate trial

Positive data show Pentarlandir is safe and effective in patients with mild-to-moderate COVID-19. SyneuRx – a company focused on the development of drugs for COVID-19 and multiple central nervous system disorders – has announced results from its phase 2 clinical trial evaluating the efficacy and safety of SNB01, a novel COVID-19 oral antiviral candidate. 89 participants suffering from breakthrough or unvaccinated cases of COVID-19 were randomised evenly into high-dose, low-dose and placebo groups. The phase 2 study showed that SNB01 – also known as Pentarlandir – can reduce the inflammation caused by COVID and improve overall health
8th Aug 2022 - PharmaTimes

Cellex drops patent case over Siemens COVID-19 tests

North Carolina biotech company Cellex Inc has dropped a patent lawsuit against Siemens Healthineers AG over the design of its rapid COVID-19 self-tests less than a week after bringing the case in Delaware, according to a court filing. Cellex told the Delaware federal court Thursday that it would dismiss the case without prejudice, which means it could be refiled in Delaware or elsewhere. The filing did not provide further details. A spokesperson for Siemens said on Saturday that the companies had not settled.
8th Aug 2022 - Reuters

BioNTech expects Omicron-adapted vaccine deliveries as soon as October

BioNTech expects to begin deliveries of two Omicron-adapted vaccines as soon as October, which will help spur demand in the fourth quarter, the German biotech firm said on Monday as it reaffirmed its vaccine-revenue forecast for the year. Demand for the vaccine, 3.6 billion doses of which have been shipped globally, is waning as most people in the Western world have received three or four shots already.
8th Aug 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Aug 2022

View this newsletter in full

Quebec records 14 new COVID-19 deaths as hospitalizations drop slightly

As of Friday, there were 2,109 COVID-19 hospitalizations — 716 of them specifically due to the disease — a decrease of 27 compared with Thursday’s total. Of those patients, 57 were in intensive care, a drop of 10 from a day earlier; 27 were in the ICU specifically because of COVID-19. The number of health-care workers absent because of COVID-19 — either due to being in isolation or as a precaution — stood at 4,910. Quebec’s COVID-19 death toll is now 16,024.
7th Aug 2022 - Montreal Gazette

80 fresh COVID-19 cases in Sikkim

Sikkim now has 559 active cases, while 40,863 people have recovered from the disease and 778 patients have migrated to other states so far
7th Aug 2022 - EastMojo

Thailand records 2,432 confirmed Covid-19 cases, 32 deaths on Wednesday

The Public Health Ministry reported on Wednesday (August 3) that over the past 24 hours, 2,432 Covid-19 patients have been admitted to hospitals, one of whom has arrived in Thailand from abroad. The death toll has risen by 32, while 2,472 patients have recovered and discharged from hospitals. The number of cumulative cases in the country since January 1, 2022, stands at 2,373,124 with 9,765 deaths.
7th Aug 2022 - Nation Thailand

Covid cases rise sharply, 446 infections recorded

After witnessing the flattening of the Covid-19 pandemic curve for nearly a month for the last four days, Mumbai is witnessing a sudden surge in the number of infections with the city registering 446 cases on Friday, which is the highest single-day count recorded in the past 18 days. In the past two weeks, the average daily Covid-19 cases were hovering around 200 in Mumbai. But since August 2, when the city reported 329 cases, the numbers are witnessing an upward spiral. The next day, the cases further climbed to 434 cases and one death was also reported. On August 4, the cases saw a slight dip with 410 infections and two deaths. On Friday, the daily caseload again surged to 446.
6th Aug 2022 - The Indian Express

Hospitalizations, deaths tied to COVID-19 up slightly, latest report says

The latest provincial report on COVID-19 in Manitoba suggests an uptick in some severe outcomes for the second week in a row, including more people landing in hospital due to the coronavirus. The report says 53 COVID-19 patients were hospitalized during the week ending July 30, compared to 45 one week earlier. Slightly fewer people ended up in intensive care units: there were seven ICU admissions, down from eight ICU admissions during the week ending July 23. There were six deaths associated with coronavirus, up from five the week before. So far, 2,067 people have died due to COVID-19 since the beginning of the pandemic.
5th Aug 2022 - CBC.ca

UK Covid-19 infections fall for second week in a row

Covid-19 infections in the UK have fallen for the second week in a row, in a fresh sign that the current wave of the virus has peaked, new figures show. The number of patients in hospital with the virus is also on a clear downwards trend. A total of 2.6 million people in private households are estimated to have had Covid-19 in the week to July 25/26, down 19% from 3.2 million in the previous week, according to the Office for National Statistics (ONS). Infections have now dropped by more than a million in the space of a fortnight.
5th Aug 2022 - The Independent

Russia's official toll of COVID-related deaths exceeds 820000

Russia has registered a total of 820,307 COVID-related deaths since the start of the pandemic in the country in April 2020, the state statistics service Rosstat said on Friday. It said 4,991 people had died of COVID-19 or related causes in June, down from 7,098 in May. Russia recorded more than 965,000 excess deaths between April 2020 and June 2022 compared with the average mortality in 2015-2019, Reuters calculations showed.
5th Aug 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Aug 2022

View this newsletter in full

Sinovac’s Covid-19 vaccine gets approval for use in children in Hong Kong

Sinovac Biotech has reported that its Covid-19 vaccine, CoronaVac, obtained approval from the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China for usage in children of the age six months to three years. The consensus interim recommendations on Covid-19 vaccine use in children aged six months or above in Hong Kong were released by the Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zoonotic Diseases under the Centre for Health Protection of the Department of Health. The approval is based on clinical trials and studies of Covid-19 inoculation in children and adolescents in the region.
4th Aug 2022 - Pharmaceutical Technology

Studies: 3 or 4 COVID vaccine doses protective against Omicron

In the first study, published yesterday in JAMA Network Open, researchers in Israel studied the effectiveness of a fourth dose of Pfizer/BioNTech mRNA COVID-19 vaccine against infection in 29,611 healthcare workers (HCWs) at 11 general hospitals who had received three vaccine doses in August or September 2021. The Omicron surge in Israel began in December 2021. The researchers tested workers for COVID-19 using polymerase chain reaction (PCR) only after symptoms emerged or they were exposed to the virus. Of all participants, 5,331 (18%) received a fourth dose in January 2022, the start of a fourth-dose vaccination campaign for Israeli HCWs, and were not infected in the first week after vaccination. Average participant age was 44 years, and 65% were women. Participants were followed until Jan 31, 2022.
4th Aug 2022 - CIDRAP

Eli Lilly Revenue Falls as Sales of Covid-19 Treatment Wanes

Eli Lilly posted a 4% decline in second-quarter revenue, as a drop in sales of the company’s Covid-19 antibody treatment and some older drugs offset gains in sales for newer drugs. The pharmaceutical company Thursday reiterated its sales forecast for the year but cut its profit outlook as the stronger U.S. dollar hurts results. Lilly said lower prices and currency translation also contributed to the declining sales, which came in below Wall Street expectations. Lilly is hoping to boost future revenue with sales of newer drugs, including Mounjaro, recently introduced to treat diabetes. Lilly is studying the same drug, also known by its generic name tirzepatide, to treat obesity, and recently reported positive clinical-trial data.
4th Aug 2022 - The Wall Street Journal

Lilly Plans to Sell Covid-19 Antibody Directly to Health-Care Providers

Eli Lilly & Co. plans to sell its Covid-19 antibody directly to health providers, states and territories in a bid to keep the drug available even as US government funding and purchases dry up. The US is working with Lilly to allow it to sell the antibody, bebtelovimab, through commercial channels, representatives for the Indianapolis-based drugmaker and the Health and Human Services Department said Wednesday. The government’s supply of the therapy will run out as early as the week of Aug. 22, according to Lilly spokeswoman Dani Barnhizer. Concern about the pandemic has ebbed as vaccines have prevented high numbers of severe cases and deaths that accompanied the outbreak’s early stages. Meanwhile, the Biden administration has been frustrated by unwillingness in Congress to provide more funds to continue buying Covid drugs and shots.
4th Aug 2022 - Bloomberg

Long COVID-19 and other chronic respiratory conditions after viral infections may stem from an overactive immune response in the lungs

Viruses that cause respiratory diseases like the flu and COVID-19 can lead to mild to severe symptoms within the first few weeks of infection. These symptoms typically resolve within a few more weeks, sometimes with the help of treatment if severe. However, some people go on to experience persistent symptoms that last several months to years. Why and how respiratory diseases can develop into chronic conditions like long COVID-19 are still unclear.
4th Aug 2022 - The Conversation

A first update on mapping the human genetic architecture of COVID-19

The COVID-19 pandemic continues to pose a major public health threat, especially in countries with low vaccination rates. To better understand the biological underpinnings of SARS-CoV-2 infection and COVID-19 severity, we formed the COVID-19 Host Genetics Initiative1. Here we present a genome-wide association study meta-analysis of up to 125,584 cases and over 2.5 million control individuals across 60 studies from 25 countries, adding 11 genome-wide significant loci compared with those previously identified2. Genes at new loci, including SFTPD, MUC5B and ACE2, reveal compelling insights regarding disease susceptibility and severity.
4th Aug 2022 - Nature.com

The Origins of Covid-19 Are More Complicated Than Once Thought

To trace the pandemic in the other direction, toward its source, the researchers turned to swab samples collected by Chinese scientists from around the Huanan market just before it was shut down by the authorities in January 2020. Those swabs returned a cluster of positives in the south-western corner of the market—on a glove found on one of the stalls, from a grate under one of the cages. Five of the positive samples came from a single stall—a stall that was known to be selling live animals in late 2019, and the same stall where Holmes had taken his photograph of the raccoon dogs five years earlier. This layering of indirect evidence has helped to settle the question of where Covid jumped into humans, but the question of timing has also been a subject of fierce debate.
4th Aug 2022 - Wired.co.uk

Moderna COVID vaccine sales forecast unchanged even as COVAX program cuts orders

Moderna Inc on Wednesday maintained its full-year COVID-19 vaccine sales forecast of $21 billion as canceled orders from low- and middle-income nations through the COVAX program offset gains from new booster dose orders. Moderna shares jumped nearly 17% in morning trading after the company also announced a $3 billion share buyback plan. Moderna has begun producing a redesigned booster shot targeting both the original coronavirus as well as the BA.4 and BA.5 Omicron subvariants.
4th Aug 2022 - Reuters

Eli Lilly to make COVID-19 antibody drug commercially available from August

Eli Lilly and Co said on Wednesday it plans to make its COVID-19 antibody drug commercially available to U.S. states as well as hospitals and other healthcare providers from August. The drug, bebtelovimab, had received authorization in the United States in February for the treatment of mild-to-moderate COVID-19 among adults and children. Eli Lilly entered an agreement in June to supply an additional 150,000 doses of the drug to the U.S. government.
4th Aug 2022 - Reuters

South Africa reports first death causally linked to COVID vaccine

South Africa's health regulator reported on Thursday a causal link between the death of an individual and Johnson & Johnson's (J&J) (JNJ.N) COVID-19 vaccine, the first time such a direct link has been made in the country. The person presented with rare neurological disorder Guillain-Barre Syndrome soon after being given J&J's Janssen vaccine, after which the person was put on a ventilator and later died, senior scientists told a news conference.
4th Aug 2022 - Reuters

Eli Lilly’s Covid-19 Antibody Treatment to Be Sold Commercially

Eli Lilly & Co. said it plans to begin commercial sales of its Covid-19 monoclonal antibody treatment to states, hospitals and other healthcare providers this month, as the federal government’s supply of the drug is nearly depleted. The move marks a shift away from the way Lilly’s drug and most other Covid-19 treatments and vaccines have been distributed in the U.S. It will likely be the first test of whether the vaccines and treatments would remain accessible if shifted to a commercial market. Previously, Lilly sold all of its Covid-19 antibody doses for use in the U.S. via contracts with the federal government. The government has made doses available for free to patients and has overseen allocation to states and pharmacies. But the government will exhaust its supply of Lilly’s Covid-19 antibody treatment, bebtelovimab, as early as the week of Aug. 22, a spokeswoman for the Indianapolis-based company said in a statement. Without new appropriations from Congress, the government lacks funds to purchase more doses from Lilly, she said.
4th Aug 2022 - The Wall Street Journal

People vaccinated against Covid share common symptom after testing positive

“It usually lasts for an average of two to three days, but can last up to seven days in adults,” the ZOE team said. The data found this symptom has become less prevalent with each variant, as nearly a third of adults aged over 35 reported having diarrhoea during the Alpha wave, while just one in five said they experienced it during the Omicron and Delta waves. The people who experienced it during the latter two waves had been vaccinated either twice or had also received their booster jab.
4th Aug 2022 - The Independent

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Aug 2022

View this newsletter in full

Novavax Covid-19 vaccine should carry warning for possible heart side-effects

The European Medicines Agency (EMA) is recommending that Novavax’s Covid-19 vaccine carry a warning of the possibility of two types of heart inflammation that could be triggered as a side effect. The EMA confirmed that the heart conditions – myocarditis and pericarditis – should be listed as new side effects in the product information for the vaccine, Reuters confirmed on Wednesday, August 3. When discussing the Novavax Covid vaccine the American Medical Association’s (AMA) Doctor Sandra Fryhofer who is the liaison to the Advisory Committee on Immunisation Practices said: “We now have a third type of vaccine in the fight against COVID.”
4th Aug 2022 - Euro Weekly News

Moderna Profit Falls Amid Charges for Unused Covid-19 Vaccines

Moderna Inc. sales rose 9% in the second quarter, but costs tied to a surplus of Covid-19 vaccine doses contributed to a profit decline. The Cambridge, Mass.-based biotechnology company’s revenue came in at $4.75 billion for the period ended June 30, topping Wall Street analyst expectations, driven almost entirely by sales of Moderna’s messenger RNA-based vaccine, branded as Spikevax. But the pace of Moderna’s year-over-year sales growth slowed significantly in the second quarter. The company’s first-quarter revenue was more than triple the year-earlier period. Moderna first introduced its Covid-19 vaccine in late 2020 and it is the company’s only product. At the same time, Moderna’s profit fell 21% to $2.2 billion because of charges tied to expired vaccine doses and changes to purchase commitments.
3rd Aug 2022 - The Wall Street Journal

EU says Novavax Covid-19 vaccine should carry heart side-effect warning

The European Medicines Agency (EMA) is recommending Novavax's Covid-19 vaccine carry a warning of two inflammatory conditions of the heart, based on a small number of reported cases. The conditions - myocarditis and pericarditis - should be listed as new side effects in the product information for the vaccine, Nuvaxovid, the EMA said on Wednesday. The agency has also requested that the US drugmaker provide additional data on the risk of these side effects occurring.
3rd Aug 2022 - Independent.ie

Moderna's COVID vaccine approved for vulnerable young children

The ATAGI experts have recommended children aged between six months and five years, who have a higher risk of developing severe illness from COVID, will be able to receive the Moderna vaccine from September 5.
3rd Aug 2022 - ABC News

Pfizer, BioNTech Initiate Phase 2 Study of Enhanced COVID-19 mRNA-Based Vaccine

Pfizer and BioNTech have initiated an active-controlled, observer-blind, phase 2, randomized study to evaluate the immune response, safety, and tolerability of an enhanced COVID-19 mRNA-based vaccine candidate at a 30-µg dose level, Pfizer said in a statement. The enhanced vaccine, BNT162b5, will consist of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain and an Omicron variant. The enhanced spike protein encoded from the mRNAs in the vaccine has been modified with the aim of increasing the breadth and magnitude of the immune response that could better protect against COVID-19. This is the first of multiple vaccine candidates with an enhanced design that the companies plan to evaluate, according to the statement.
3rd Aug 2022 - Pharmacy Times

Moderna's 2Q earnings beat expectations, but it writes off $500 million in expiring Covid shots

Moderna beat Wall Street’s quarterly earnings and revenue expectations. The Boston biotech company generated $4.7 billion in sales for the quarter, a 9% increase over the same period last year. Moderna posted adjusted earnings of $5.24 per share, an 18% drop from the second quarter of 2021. But the company took a nearly $500 million hit on write-downs for vaccine inventory that has expired or is expected to expire before it can be used.
3rd Aug 2022 - CNBC

How much do face masks protect you against COVID-19?

Health authorities no longer force people in Australia to wear face masks except in certain situations, but previous studies show how effective wearing a mask can be in stopping you from getting COVID-19. From around February this year, most states and territories gradually removed requirements for people to wear face masks except in limited circumstances. Current mandates vary slightly across jurisdictions but masks are generally still required while travelling on public transport and planes, and when in hospitals and aged care centres. The requirement for people to wear masks in airport terminals was removed after the Australian Health Protection Principal Committee (AHPPC) said in June it was no longer appropriate. The decision whether or not to wear a mask in most public indoor spaces such as shopping centres and in offices is now down to individual choice.
3rd Aug 2022 - SBS News

Moderna Sales Climb on Strong Demand for Covid-19 Vaccine

Gilead Boosts Sales Forecast on Demand for Covid-19 Drug

Gilead Sciences Inc. raised its sales forecast for the year, mostly due to anticipated demand for the Covid treatment Veklury. The drugmaker said Tuesday that it now sees total product sales between $24.5 billion and $25 billion this year, up from its April forecast of $23.8 billion to $24.3 billion. That includes about $2.5 billion in Veklury sales, compared with a prior forecast of about $2 billion. In the second quarter, sales of Veklury, also known as remdesivir, fell to $445 million from $1.5 billion in the first quarter, reflecting the increased availability of other treatments and a drop in Covid-19 hospitalizations in the US. Analysts had expected Veklury sales of $376.4 million in the second quarter.
3rd Aug 2022 - Bloomberg

Covid-19: Memory problems are more common in people who lose the sense of smell

Persistent loss of smell is a better predictor of lingering cognitive symptoms after covid-19 infection than disease severity. A common symptom of covid-19 is a sudden loss of smell. Previous research has found that smell loss can be an early warning sign of Alzheimer’s disease and other conditions. Evidence suggests that covid-19 can also lead to long-lasting neurological problems like difficulty concentrating and memory loss. To see if loss of smell due to covid-19 is associated with persistent cognitive symptoms, Gabriela Gonzalez-Alemán at the Pontifical Catholic University of Argentina in Buenos Aires and her colleagues analysed data from 766 adults aged 60 years or older who had no history of cognitive impairment. Each had taken a PCR test at a covid-19 testing clinic in Argentina, and nearly 90 per cent tested positive.
3rd Aug 2022 - New Scientist

The curious case of the Covid-19 rebound

If we've learned anything over the past two and a half years, it's that Covid-19 is one strange disease. The latest case in point: the coronavirus rebound. The condition grabbed international attention last week when US President Joe Biden tested positive for the virus six days after testing negative following his first bout of the illness. The White House said Biden, who is back in isolation, was experiencing a bit of a "loose cough" but did not have a fever and his lungs were "clear." The President tested positive again after being treated with the antiviral Paxlovid. White House officials had previously suggested a rebound case of Covid was unlikely, based on reports of cases around the country, but Biden's doctors continued to monitor his health and test him.
3rd Aug 2022 - CNN

Moderna maintains vaccine sales view on lower COVAX orders

Omicron better at invading young noses than other variants; smell loss may predict memory issues

The Omicron variant may be more efficient at infecting children through the nose than previous versions of the coronavirus, a small study suggests. Earlier in the pandemic, children's noses had been less welcoming to the virus that causes COVID-19 than adults' noses. Studies of the original SARS-CoV-2 and some of its variants found the virus was met with stronger immune responses in the cells lining young noses than in adults' nasal-lining cells, and it was less efficient at making copies of itself in children's noses. But recent test-tube experiments mixing the virus with nasal cells from 23 healthy children and 15 healthy adults found the antiviral defenses in kids' noses "was markedly less pronounced in the case of Omicron," researchers reported on Monday in PLOS Biology.
3rd Aug 2022 - Reuters

COVID-19 tracker: EU recommends heart inflammation warning for Novavax shot

Regulators are Europe recommend that Novavax's vaccine be tagged with warnings about the risk of myocarditis and pericarditis after a small number of cases were recorded, Reuters reports. The U.S. FDA reached a similar decision back in June, according to the news service. So far, just 250,000 doses of the shot have been administered in Europe. While around 7 million people in the United States who have weaker immune systems are eligible for AstraZeneca's COVID-19 antibody Evusheld, few are actually receiving it, Bloomberg reports. The treatment is intended to help protect people who do not produce a strong response to vaccination. So far, health care providers have ordered just 800,000 courses of the treatment, the news service reports, citing federal data.
3rd Aug 2022 - FiercePharma

Regeneron puts kibosh on 4 antibody studies as Pfizer's Paxlovid dominates the COVID treatment scene

In a sign of the times, Regeneron Pharmaceuticals—whose antibody cocktail REGEN-COV once helped form the vanguard of COVID-19 therapeutics—has axed a clutch of trials weighing the med across a range of patients and clinical stages. The move comes about half a year after the FDA pulled the cocktail from the market after data suggested its efficacy had waned in the face of the surging omicron variant. It’s a fate shared by a number of early-pandemic therapeutics, which have largely fallen by the wayside in the U.S. as the virus swiftly evolves. Now, Regeneron has terminated four clinical trials of REGEN-COV, comprising the monoclonal antibodies casirivimab and imdevimab.
3rd Aug 2022 - FiercePharma

Paxlovid rebound happens, though why and to whom are still a mystery

As an emergency department physician in New York, I often field calls about medical issues from family members, friends, and even friends of friends. Since the Covid-19 pandemic began, the number of these calls has dramatically increased. The latest slew of these, about Paxlovid and rebound Covid-19 — which President Biden now apparently has — has revealed the confusion surrounding this phenomenon for me, my physician colleagues, and at least one Nobel laureate. I recently got a call from my friend Joachim Frank, who shared the Nobel Prize in Chemistry in 2017, about his rebound Covid after doing what he was supposed to do: taking Paxlovid as his doctor had prescribed.
2nd Aug 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Aug 2022

View this newsletter in full

Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for mRNA Covid-19 vaccine.
2nd Aug 2022 - Pharmaceutical Technology

Bharat Biotech expects regulator’s nod for intranasal Covid-19 vaccine in August

Bharat Biotech, which is working on an intranasal Covid-19 vaccine, is hopeful of getting regulatory licenses this month, Chairman and Managing Director of BBIL, Krishna Ella said.
2nd Aug 2022 - Deccan Herald

Fewer pregnant women had severe COVID amid Omicron, after vaccination

Fewer pregnant women had severe COVID-19 in the Omicron variant-era than during periods dominated by previous strains, and vaccinated patients were better protected than their unvaccinated peers, according to research published yesterday in the American Journal of Infection Control. Investigators from South Korea retrospectively examined the electronic medical records of 224 pregnant women who tested positive for COVID-19 and 82 quarantine deliveries from Nov 1, 2020, to Mar 7, 2022, at a single hospital. Average maternal age was 32 years. Pregnant women admitted to the hospital before Jan 17, 2022 were considered to be infected with the Delta variant, while those after that date were considered infected with Omicron. Of the 224 women, 39 (17%) were vaccinated, and 185 (83%) were unvaccinated against COVID-19.
2nd Aug 2022 - CIDRAP

Analysis | What Experts Know About 'Long Covid' and Who Gets It

Most people who suffer from Covid-19 fully recover. Millions of others find complete healing to be frustratingly elusive, in what’s often referred to as long Covid. Symptoms range from pulmonary, cardiovascular, gastrointestinal or neurological problems to cognitive issues such as so-called brain fog. No single explanation, diagnosis or treatment can be applied to them. Colloquially known as long-haulers, these patients reflect the pandemic’s lasting burden on society and the economy.
2nd Aug 2022 - The Washington Post

People vaccinated against Covid share common symptom after testing positive

While it may be widely known that common symptoms of Covid include fatigue, a sore throat, and headaches, there is another widespread symptom being cited among sufferers. According to data gathered by the ZOE Health Study app, diarrhoea is a common symptom of Covid for vaccinated Britons. Data shows that there was a rise in people reporting this symptom in January 2022, and that some of this was related to the Omicron variant of Covid-19. However, the ZOE team pointed out that there seemed to be a “wave of other non-Covid tummy bugs going around too”. The team said that diarrhoea can be an early symptom of the virus, starting on the first day of infection and getting worse throughout the week.
2nd Aug 2022 - The Independent

Vaccine patch offers more robust protection against omicron, delta COVID-19 variants

A COVID-19 vaccine patch is more effective at fighting variants such as delta and omicron than a traditional needle shot, a new study has found. The research, conducted by Australia’s University of Queensland and in partnership with Brisbane-based biotech company Vaxxas, deduced that the needle-free COVID-19 vaccine patch could offer more robust protection against the virus, which has so far claimed over 6.4 million lives since the outbreak in December 2019. The researchers analyzed the Hexapro SARS-CoV-2 spike vaccine using Vaxxas high-density microarray patch (HD-MAP) technology. “The high-density microarray patch is a vaccine delivery platform that precisely delivers the vaccine into the layers of the skin which are rich in immune cells,” said Christopher McMillan of Queensland University in a statement.
2nd Aug 2022 - Al Arabiya English

COVID-19 rebounds like Biden's 'should not dissuade' patients from taking Paxlovid

President Joe Biden tested positive for SARS-CoV-2 again on Monday, the White House announced — the third day in a row he tested positive after testing negative for 3 days last week. Biden, who is fully vaccinated and has received two boosters, has a case of so-called “rebound” COVID-19, which has been reported in some patients after being treated with Paxlovid. He first tested positive on July 21 and experienced “very mild” symptoms, according to the White House.
2nd Aug 2022 - Healio

Life expectancy drops for Native Americans due to COVID-19

Native Americans experienced disproportionately high rates of deaths from COVID-19 due to poverty, crowded housing, high rates of chronic disease, employment in frontline jobs, and limited access to quality health care. Less is known about the pandemic's effects on life expectancy for this population, which makes up 2% of the U.S. population. Noreen Goldman of Princeton University and Theresa Andrasfay, Ph.D. '20 of the University of Southern California investigated life expectancy at birth in 2020 and 2021 -- when COVID-19 rates were surging -- compared to 2019. Life expectancy is a metric of population-level mortality in a given year, and it is sensitive to deaths at younger ages.
2nd Aug 2022 - Science Daily

FDA reauthorizes Meridian's COVID-19 test after changes to enable omicron detection

The Food and Drug Administration reauthorized Meridian Bioscience’s Revogene SARS-CoV-2 molecular assay for emergency use. U.S. regulatory officials warned late last year that the previous version of the test was unable to detect the omicron COVID-19 variant, leading Meridian to modify the design of the assay. The work led Meridian, which is the subject of a pending $1.53 billion takeover, to submit initial data on the revised assay in March and ultimately to win renewed emergency use authorization (EUA).
2nd Aug 2022 - MedTech Dive

Testing negative to COVID-19 but still have symptoms? Here's what you need to know

You have the telltale signs of COVID — fever, headache, dry cough and exhaustion — but your rapid antigen test is returning a negative result. You're not alone. So, if you're testing negative on a RAT but still have symptoms, or if you need to record a positive RAT test result — here's a refresh on what to do.
2nd Aug 2022 - ABC News

GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine

GreenLight Biosciences and Samsung Biologics have completed the first commercial-scale engineering run under the companies’ mRNA production partnership: ahead of a COVID-19 vaccine booster clinical trial due to start later this year.
2nd Aug 2022 - BioPharma-Reporter

Reduced severity of COVID-19 in pregnant women during the Omicron wave

In South Korea, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for the coronavirus disease 2019 (COVID-19) pandemic, has infected a considerable number of pregnant women, including those who have delivered by cesarean section. Pregnancy is considered a high-risk factor for severe COVID-19, particularly among infections due to the SARS-CoV-2 Delta variant. The clinical course of infection with the SARS-CoV-2 Omicron variant remains unknown in pregnant women. Furthermore, due to the low vaccination rate of less than 10% in South Korea, information regarding COVID-19 vaccine efficacy in pregnant women is also insufficient.
2nd Aug 2022 - News-Medical.Net

Covid-19: is omicron less lethal than delta?

Soon after the omicron SARS-CoV-2 variant of concern was first reported to the World Health Organization on 24 November 2021, preliminary observational studies in South Africa suggested this highly transmissible variant was associated with lower hospital admission and mortality rates in people with covid-19 infection.1 However, given omicron’s increased propensity to cause reinfections and vaccine breakthrough,23 it was unclear if this effect was due to previous immunity in the population or an inherent property of the genetically divergent variant. Subsequent analyses further supported a lower risk of severe outcomes in infections with omicron compared with delta, although these data were limited to all cause deaths within 28 days of diagnosis. Additionally, many public health measures previously enacted to curb SARS-CoV-2 transmission were being relaxed in early 2022, potentially resulting in more infections in relatively low risk populations. These limitations complicated efforts to assess the true risk of severe disease and mortality associated with omicron infection.
2nd Aug 2022 - The BMJ

Axcella long COVID treatment helps some patients in small trial

One of the first trials aimed at tackling long COVID helped some patients recover from lingering physical and mental fatigue, although the drug developed by Axcella Health Inc failed on the small study's main goal of restoring the normal function of mitochondria - the energy factories of cells. In the 41-patient pilot study released on Tuesday, for three of 21 patients who received the drug, AXA1125, their physical fatigue scores returned to normal levels after 28 days of treatment, Axcella Chief Medical Officer Margaret Koziel said in a phone interview.
2nd Aug 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Aug 2022

View this newsletter in full

Polio found in New York wastewater as state urges vaccinations

The polio virus was present in wastewater in a New York City suburb a month before health officials there announced a confirmed case of the disease last month, state health officials said on Monday, urging residents to be sure they have been vaccinated. The discovery of the disease from wastewater samples collected in June means the virus was present in the community before the Rockland County adult's diagnosis was made public July 21.
2nd Aug 2022 - Reuters

Moderna signs contract to supply Covid-19 booster vaccines to US

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA). Spikevax is the company’s Covid-19 vaccine intended for active immunisation for disease prevention in people aged 18 years and above.
1st Aug 2022 - Pharmaceutical Technology

Moderna secures £1.74bn deal to supply US government with updated COVID-19 vaccine

Moderna has announced it has secured a deal with the US government to supply 66 million doses of its COVID-19 vaccine booster updated for the Omicron subvariant for use in an autumn and winter campaign. The company will receive up to £1.74bn for the manufacture and delivery of the doses of mRNA-1273.222, a bivalent booster candidate containing Moderna’s COVID-19 vaccine Spikevax plus the Omicron BA.4/5 string mRNA. The US government will also have the option to purchase up to an additional 234 million doses. Commenting on the deal, Stéphane Bancel, chief executive officer of Moderna, said: "We are pleased to extend our successful collaboration with the US government. Moderna's mRNA platform is enabling us to rapidly create mRNA-1273.222, a bivalent vaccine that specifically targets Omicron subvariants BA.4 and BA.5, the most prevalent variants of concern in the US today
1st Aug 2022 - PMLiVE

SK Bioscience eyes Europe as market for COVID-19 vaccine

SK Bioscience has submitted the application for conditional approval of the COVID-19 vaccine SKY Covione with the European Medicines Agency in efforts to expand its presence in the global market, the South Korean vaccine developer said Monday. Beginning with the European region, SK Bioscience said it will look to showcase the South Korean COVID-19 vaccine on the global stage as the size of the coronavirus vaccine market grows rapidly. South Korea’s Ministry of Food and Drug Ministry gave the green light to SKYCovione at the end of June as the country became the third nation in the world with a homegrown COVID-19 treatment and a domestically-developed vaccine, behind the UK and US.
1st Aug 2022 - The Korea Herald

Pfizer and BioNTech start trial of 'next-gen' COVID vaccine

The two companies h(Pfizer and BioNTech) ave begun a Phase II study on an ‘enhanced’ version of their mRNA vaccine against COVID-19, a so-called 'nextgen' Covid vaccine
1st Aug 2022 - BioPharma-Reporter.com

COVID-19 Pandemic Dramatically Increased Childcare Stress Among Health Care Workers

A September 2021 poll revealed that 1 in 5 health care workers (HCWs) quit their job since March 2020. Pre-existing disparities and issues in the health care workforce and within the current childcare system were exacerbated because of the COVID-19 pandemic, according to the poll. Researchers found that childcare stress (CCS) was associated with anxiety, depression, burnout (occupational stress), intent to reduce (ITR), and intent to leave (ITL) for HCWs, which were experienced at disproportionate levels across different subgroups. The source of the study, called Coping with COVID, is a 14-item survey looking at several demographic items, such as race, ethnicity, gender, years in practice, outpatient vs inpatient practice environment, and work role between April-December 2020.
1st Aug 2022 - Pharmacy Times

'Living with COVID': Where the pandemic could go next

As the third winter of the coronavirus pandemic looms in the northern hemisphere, scientists are warning weary governments and populations alike to brace for more waves of COVID-19. In the United States alone, there could be up to a million infections a day this winter, Chris Murray, head of the Institute of Health Metrics and Evaluation (IHME), an independent modeling group at the University of Washington that has been tracking the pandemic, told Reuters. That would be around double the current daily tally.
1st Aug 2022 - Reuters

Studies investigate impact of COVID-19 pandemic on memory and thinking changes

Researchers present findings at world’s largest dementia research conference Persistent loss of smell after COVID-19 linked to memory and thinking changes associated with diseases like Alzheimer’s. Links between life changes during pandemic, and memory, investigated. Intensive care admissions (not necessarily COVID-19) associated with dementia risk
1st Aug 2022 - Alzheimer's Research UK

Covid warning over symptom of new strain that affects sufferers at night

An immunologist has warned the new strain of Covid-19 could be causing different symptoms – including one that emerges during the night. Omicron BA.5 is a highly-contagious subvariant prompting concern as it contributes to a fresh wave of infections across the globe, including the UK. Scientists have been finding differences with previous strains, including the ability to reinfect people within weeks of having Covid. A leading immunologist has now suggested it could be causing a new symptom among patients. “One extra symptom from BA.5 I saw this morning is night sweats,” Professor Luke O’Neill from Trinity College Dublin told an Irish radio station in mid-July.
1st Aug 2022 - The Independent

Habitual mask-wearing is likely helping Japan, Singapore and South Korea bring daily Omicron deaths down, epidemiologists say

As the mask mandate debate rages on in Australia, epidemiologists and medical specialists suggest looking to countries where citizens are perfectly happy to wear them to see how powerful the simple infection-control measure can be. Nearly two and a half years into the COVID-19 pandemic, countries where mask-wearing is a cultural norm are seeing some signs of success as the persistent Omicron sub-variants spread throughout their communities. University of Otago public health professor and epidemiologist Michael Baker said underlying the widespread acceptance of masks in some countries was a sense of personal responsibility to protect others from COVID-19. "I'm looking at the countries that appear, on paper, to be keeping their mortality very low … despite having lots of circulating virus, and it's basically the Asian countries, particularly Japan, South Korea, Singapore," he said.
1st Aug 2022 - ABC News

An administrative bungle caused Queensland's COVID cases to be under reported

While Saturday's COVID case count appears to show a massive spike of more than 18,000, Queensland Health says this is due to an administrative error and many are historic.
1st Aug 2022 - ABC News

COVID's deadly 'payback period'

We're heading for another peak in infections, and the daily death toll has never been so high, while worldwide we appear to be faring worse than just about anywhere else. But why? And how many more waves will Australia need to endure? Today, epidemiologist Professor Tony Blakely on why Australia's early success at keeping the virus at bay now seems to be working against us. Featured: Professor Tony Blakely, epidemiologist, School of Population and Global Health, University of Melbourne
31st Jul 2022 - ABC News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Aug 2022

View this newsletter in full

Reinfection, severe outcome more common with BA.5 variant; virus spike protein toxic to heart cells

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Reinfections, severe outcomes may be more common with BA.5. Compared with the earlier Omicron BA.2 subvariant, currently dominant Omicron BA.5 is linked with higher odds of causing a second SARS-COV-2 infection regardless of vaccination status, a study from Portugal suggests.
30th Jul 2022 - Reuters

Pfizer and BioNTech initiate phase 2 study of ‘enhanced’ COVID-19 vaccine

Pfizer and BioNTech have initiated a phase 2 study evaluating a new version of the COVID-19 vaccine that the companies hope will better protect against the virus. The Pfizer-BioNTech COVID-19 vaccine, BNT162b5, consists of RNAs encoding ‘enhanced’ prefusion spike proteins for the SARS-CoV-2 wild-type strain and an Omicron variant, with the aim of increasing the magnitude and breadth of the immune response. The vaccine candidate will be evaluated in a US-base study, enrolling around 200 participants aged 18 to 55 who have already received one booster dose at least 90 days prior to their enrolment in the study. The participants will be divided into subgroups based on the number of months since their last dose. The study does not include a placebo. BNT162b5 is the first of multiple vaccine candidates with an enhanced design, the companies stated, representing their long-term COVID-19 vaccine strategy to overcome the relatively short-lived immune response seen with their first-generation vaccine, BNT162b2.
29th Jul 2022 - PMLiVE

Serious self-harm in young people jumped during strict COVID-19 lockdowns - study

Serious self-harm among young people jumped during strict COVID-19 lockdowns, new research shows. The study found that boys needing urgent support from emergency services doubled, and then tripled for children in care. Meanwhile, girls continued to be over-represented in self-harm figures, researchers said. It comes after another study suggested that people living in poverty are more likely to suffer with long COVID. Psychiatrists have called for more funding and development of community mental health services due to the findings, which have been published in the Royal College of Psychiatrists' BJPsych Open
29th Jul 2022 - Sky News

Could next-generation vaccines finally end the covid-19 pandemic?

The coronavirus vaccines have been a brilliant success, possibly saving tens of millions of lives. But they haven’t ended the pandemic and their effectiveness has been eroded by the evolution of variants of the SARS-CoV-2 coronavirus. A new generation of covid-19 vaccines is needed – but what exactly should this involve? The US plans to roll out boosters that target the BA.4 and BA.5 omicron subvariants.
29th Jul 2022 - New Scientist

Reinfection, severe outcome more common with BA.5 variant; virus spike protein toxic to heart cells

Compared with the earlier Omicron BA.2 subvariant, currently dominant Omicron BA.5 is linked with higher odds of causing a second SARS-COV-2 infection regardless of vaccination status, a study from Portugal suggests. From late April through early June, researchers there studied 15,396 adults infected with the BA.2 variant and 12,306 infected with BA.5. Vaccines and boosters were equally effective against both sublineages, according to a report posted on Monday on medRxiv ahead of peer review. However, 10% of BA.5 cases were reinfections, compared to 5.6% of BA.2 cases, which suggests a reduction in protection conferred by previous infection against BA.5 compared to BA.2, the researchers said. Moreover, the vaccines appeared to be less effective in reducing the risk of severe outcomes for BA.5 compared with BA.2.
29th Jul 2022 - Reuters

CanSinoBIO's inhaled COVID booster stronger against BA.1 Omicron subvariant than Sinovac shot

Chinese vaccine firm CanSino Biologic's inhalation-based candidate elicited a better antibody response as a booster against the BA.1 Omicron sub-variant than Sinovac's shot, but the antibody level dropped in months, clinical trial data showed. The result came as top political leaders in China called for proper tracking of virus mutation and developing of new vaccines and treatments in the country's effort to refine its COVID control strategy.
29th Jul 2022 - Reuters

If you're high risk, do not wait for updated COVID vaccines, experts say

People at high risk of severe disease who have yet to get a second COVID-19 booster should not wait for next-generation, Omicron-targeted vaccines expected in the fall, five vaccine experts told Reuters. In many countries, including the United States, the BA.5 Omicron subvariant of the virus is surging, but current vaccines continue to offer protection against hospitalization for severe disease and death.
29th Jul 2022 - Reuters

AstraZeneca lifts revenue guidance on COVID treatment

AstraZeneca (AZN.L) said it expected prescriptions of its COVID therapy to drive sales growth of more than 20% this year, as company reported second-quarter profit that topped analyst estimates. The injection, called Evusheld, which is designed to protect against COVID infection for at least six months, has been deployed in many countries for people with compromised immune systems who see little or no benefit from vaccines.
29th Jul 2022 - Reuters

Covid Leaves Some 5% of People With Faulty Sense of Smell, Taste

Losing the sense of smell and taste has become a hallmark of coronavirus infection. But a new study finds that the problem persists in some 5% of patients, disrupting their everyday lives and providing yet another set of symptoms to chalk up to long Covid. The scientists drew their conclusion after reviewing 18 studies involving more than 3,600 patients. The findings mean that as many as 15 million patients may be affected worldwide, they said in a paper published Thursday in the UK medical journal BMJ. Women were less likely to recover than men, the research found, as were patients whose symptoms were strongest or who had nasal congestion. Overall, most patients regained their sense of smell and taste within three months.
27th Jul 2022 - Bloomberg

How long-term Covid-19 immunity paves the way for universal Covid-19 vaccines

In recent months, scientists have also learned that the immune cells that provide lasting protection — known as memory B cells and T cells — can keep the worst effects of the most recent versions of the virus at bay, even if they were trained to corral older strains of SARS-CoV-2. Vaccine researchers are expanding their focus from antibodies to these memory immune cells as the new discoveries open a path toward universal coronavirus vaccines. Universal vaccines, however, are still a long way off — possibly years — drawing on approaches never used before. “That’s a scientific challenge,” said Anthony Fauci, chief medical adviser to the president, during the summit.
29th Jul 2022 - Vox.com

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Jul 2022

View this newsletter in full

Air Pollution Likely to Contribute to Diseases Including Dementia, UK Committee Finds

Air pollution is "likely" to increase the risk of developing dementia, a Government research group has said. The Committee on the Medical Effects of Air Pollutants has published its findings after reviewing almost 70 studies which analysed how exposure to emissions affect the brain over time. The 291-page report concludes that air pollution "likely" increases the risk of accelerated "cognitive decline" and of "developing dementia" in older people. Experts believe this is due to the impact of pollutants entering the circulatory system, affecting blood flow to the brain.
28th Jul 2022 - Bloomberg

What the UK is Getting Right in the Fight to Contain Monkeypox

As global concerns mount about the threat of monkeypox, the UK offers a measure of hope that the crisis is controllable. Just days after the World Health Organization declared the outbreak a public health emergency, the UK released data suggesting that transmission is plateauing. That’s giving health experts a dash of optimism. “The figures that we are seeing, certainly with the eye of faith, do look as though they are slowing down,” Jimmy Whitworth, a professor of public health at the London School of Hygiene and Tropical Medicine, said in a phone interview. “It doesn’t mean we’re out of the woods, but it is an encouraging sign.”
28th Jul 2022 - Bloomberg

CityU researchers invents accurate rapid COVID-19 antibody level test

Vaccines have become the most important weapon in the fight against the COVID-19 pandemic, but antibody levels after vaccination decay quickly over time. Therefore, an accurate and affordable antibody rapid test is urgently needed to adjust the revaccination strategy. A research team led by City University of Hong Kong (CityU) recently invented an accurate rapid-testing device that can quantify and display the antibody level as a length of a visual bar, like a mercury thermometer, in as few as 20 minutes, enabling convenient mass screening or individual monitoring of immune protection against COVID-19.
28th Jul 2022 - EurekAlert!

Pfizer and BioNTech speak out against CureVac suit over patents for COVID-19 vaccines

Global clinical-stage biopharmaceutical company, CureVac, filed a lawsuit earlier this month against BioNTech, making the claim that CureVac should be compensated for an apparent infringement of a range of patents. The suit took place in German court and BioNTech has declared that it is contesting CureVac’s allegations, and called upon its partner, Pfizer, in a Massachusetts court filing to counter the claims. Both BioNTech and Pfizer assert that following CureVac’s failed attempts to develop a COVID-19 vaccine, CureVac tried to profit from the partnership, threatening patent infringement and legal action as a means of correcting CureVac’s ‘meritless allegations’.
28th Jul 2022 - PMLiVE

In Rural America, Covid Hits Black and Hispanic People Hardest

At the peak of the Omicron wave, Covid killed Black Americans in rural areas at a rate roughly 34 percent higher than it did white people. The coronavirus pandemic walloped rural America last year, precipitating a surge of deaths among white residents as the virus inflamed longstanding health deficits there. But across the small towns and farmlands, new research has found, Covid killed Black and Hispanic people at considerably higher rates than it did their white neighbors. Even at the end of the pandemic’s second year, in February 2022, overstretched health systems, poverty, chronic illnesses and lower vaccination rates were forcing nonwhite people to bear the burden of the virus. Black and Hispanic people in rural areas suffered an exceptionally high toll, dying at far higher rates than in cities during that second year of the pandemic.
28th Jul 2022 - The New York Times

Fauci calls BA.5 a ‘moving target’ that may subside by the time Omicron boosters are ready. Scientists are pushing for a universal COVID vaccine instead

Vaccines made specifically to tackle the BA.5 subvariant of COVID should be ready by this fall, Dr. Anthony Fauci, U.S. President Joe Biden’s chief medical advisor, told The Hill this week. But the vaccines could suffer from one major flaw—BA.5-specific vaccines may become less effective once the Omicron subvariant is replaced by another strain, a real possibility given that dominant strains have been replaced with more competitive forms of the virus roughly every six months during the course of the pandemic. “You’re dealing with a moving target,” he said on The Hill’s Rising television show. “There’s always the possibility that you’re going to have the evolution of another variant… And hopefully, if that occurs, it will vary off from the BA.5 only slightly—in the sense of being a sub-sublineage of it, and not something entirely different.”
28th Jul 2022 - Fortune

Millions still without sense of smell or taste after Covid-19

Still struggling with your sense of smell after a bout with Covid-19? You’re far from alone. About 5% of patients with confirmed cases of Covid-19 — some 27 million people worldwide — are estimated to have suffered a long-lasting loss of smell or taste, a new analysis suggests. In the analysis published Wednesday in The BMJ (the peer-reviewed medical journal of the British Medical Association), researchers evaluated 18 previous studies of smell and taste loss across several continents and in varying demographic groups. About three quarters of those affected by loss of taste or smell regained those senses within 30 days. Rates of recovery improved over time, but about 5% of people reported “persistent dysfunction” six months after their infection with Covid-19.
28th Jul 2022 - CNBC

EMA task force begins review of Veru's sabizabulin for Covid-19

The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk. The review will facilitate the use of the therapy for emergency usage in countries in the EU. Under this process, the ETF will analyse all available data, including findings from a trial in moderate-to-severe Covid-19 patients admitted to the hospital with increased ARDS and mortality risk. According to the study findings, treatment with sabizabulin lowered the number of deaths in these subjects versus placebo.
28th Jul 2022 - Pharmaceutical Technology

COVID-19 Moderna vaccine induces significant antibody reactions among children

In a recent article published in the Science Translational Medicine journal, researchers illustrated that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccination triggers potent antibody reactions in children.
28th Jul 2022 - News-Medical.Net

COVID-19: Millions could suffer from long-term smell or taste problems after coronavirus infection, study says

Around one in 20 people who have tested positive for COVID-19 worldwide have long-term smell or taste problems for at least 6 months, a new study has found. The survey was put together by a team of international experts, including some from the UK and analysed data from 18 studies comprising 3,699 patients. Published in the BMJ, it used modelling to estimate how many people go on to suffer from altered taste or smell for at least six months after a COVID-19 infection. It found that an estimated 5.6% of patients suffer smell dysfunction for at least six months, while 4.4% have a change in taste
28th Jul 2022 - Sky News

UK scientists take ‘promising’ step towards single Covid and cold vaccine

Scientists have made a “promising” advance towards developing a universal coronavirus vaccine to tackle Covid-19 and the common cold. Researchers at the Francis Crick Institute in London have discovered that a specific area of the spike protein of Sars-CoV-2 – the virus that causes Covid-19 – is a good target for a pan-coronavirus jab that could offer protection against all the Covid-19 variants and common colds. Developing a vaccine that protects against a number of different coronaviruses is a huge challenge, they said, because this family of viruses have many key differences, frequently mutate and generally induce incomplete protection against reinfection. That is why people can repeatedly catch common colds, and why it is possible to be infected multiple times with different variants of Sars-CoV-2.
28th Jul 2022 - The Guardian

Pfizer profit beats estimates on higher demand for COVID products

Pfizer Inc did not raise its 2022 forecast for sales of its COVID-19 vaccine and antiviral treatment on Thursday, and its shares fell nearly 5% before recovering. The U.S. drugmaker maintained its full-year forecast of around $54 billion for its COVID products, even as second-quarter sales of its Paxlovid antiviral pills were much higher-than-expected, raising concerns among some analysts over Pfizer's long-term growth prospects.
28th Jul 2022 - Reuters

COVID-19: People living in poverty more likely to get long COVID, study suggests

According to the Institute for Fiscal Studies (IFS), people with coronavirus symptoms lasting more than four weeks are more likely to have been living in social housing or claiming benefits before they got ill. Previous studies have shown that long COVID patients are more likely to be women, middle-aged and have an underlying health condition.
27th Jul 2022 - Sky News

Persistent brain fog, hair loss highlighted in long-COVID studies

The first study, by University of Oslo researchers in Norway, was published yesterday in Open Forum Infectious Diseases. The team used four computer-based cognitive tests from the Cambridge Neuropsychological Test Automated Battery to assess 75 adult COVID-19 patients' cognitive function 13 months after release from a single hospital. Included patients were, on average, 55.7 years old and were admitted to the hospital up to June 2020. The four tests were delayed matching to sample (DMS) (testing short-term memory, visuospatial processing, learning, and attention), the One-touch Stockings of Cambridge (OTS) test (executive function), rapid visual-information processing (RVP) (sustained attention), and spatial working memory and strategy (SWM).
27th Jul 2022 - CIDRAP

Can we really get better Covid vaccines? There are big hurdles, but some hope

On Tuesday, White House officials gathered scientists, pharmaceutical executives, and experts in public health at a summit to try to lay out a path toward creating better vaccines. What was the upshot? For starters, there was tremendous optimism about the prospects for developing next-generation vaccines. And there were, in fact, glimmers of a tractable path to better products — if Congress will provide billions of dollars to speed things up.
27th Jul 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Jul 2022

View this newsletter in full

Novavax Covid-19 vaccine gets Australian TGA approval for adolescents

Novavax has received expanded approval for provisional registration from the Australian Therapeutic Goods Agency (TGA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. Nuvaxovid is indicated for active immunisation for the prevention of Covid-19 in individuals of this age group. It is the first protein-based vaccine to be offered in Australia for adolescents aged 12 to 17 years. The approval is based on findings from the paediatric expansion of the Phase III PREVENT-19 clinical trial of 2,247 adolescents of this age group at 73 sites in the US.
27th Jul 2022 - Pharmaceutical Technology

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

This is the first of multiple vaccine candidates with an enhanced design which the companies plan to evaluate as part of a long-term scientific COVID-19 vaccine strategy to potentially generate more robust,
27th Jul 2022 - The Associated Press

The Future of COVID Vaccines: will you need constant boosters or is a single "forever" shot possible?

Most Australians over 30 are now eligible for their fourth COVID vaccine booster shot. But will there ever be a "forever" vaccine, that removes the need for boosters? Or a vaccine that stops you contracting COVID in the first place? Royal Melbourne Hospital's Dr Kudza Kanhutu specialises in infectious diseases and has a background in immunology. Hear her discuss what the future of COVID vaccines might look like with Nadia on Mornings
27th Jul 2022 - ABC News

Bharat Biotech, ExcellGene consortium to develop variant-proof Covid vax

Switzerland’s ExcellGene SA has announced its role in the recently approved consortium funding through the Coalition for Epidemic Preparedness Innovations (CEPI) for co-developing a variant-proof coronavirus vaccine with India’s Bharat Biotech. The consortium is developing or designing a new vaccine concept that confers highly cross-reactive protection against numerous SARS-CoV-2 variants of concern as well as other betacoronaviruses.
27th Jul 2022 - Business Standard

New studies bolster theory coronavirus emerged from the wild

Two new studies provide more evidence that the coronavirus pandemic originated in a Wuhan, China market where live animals were sold – further bolstering the theory that the virus emerged in the wild rather than escaping from a Chinese lab. The research, published online Tuesday by the journal Science, shows that the Huanan Seafood Wholesale Market was likely the early epicenter of the scourge that has now killed nearly 6.4 million people around the world. Scientists conclude that the virus that causes COVID-19, SARS-CoV-2, likely spilled from animals into people two separate times. “All this evidence tells us the same thing: It points right to this particular market in the middle of Wuhan,” said Kristian Andersen a professor in the Department of Immunology and Microbiology at Scripps Research and coauthor of one of the studies.
27th Jul 2022 - The Independent

How Much Rest Do You Really Need When You Get Covid-19?

Many people feel the urge to power through after testing positive for Covid-19. President Biden recently told Americans he was “getting a lot of work done” after testing positive and tweeted a photo of himself signing a bill at his desk. Doctors say it is important to rest, even for people with mild to moderate cases of the virus. Some doctors worry that as we get more inured to the pandemic, some people with symptoms aren’t taking enough down time. Pushing yourself too hard can lengthen your recovery, they say, adding that the healing trajectory for Covid-19 is less predictable than for other respiratory illnesses.
27th Jul 2022 - The Wall Street Journal

Does the Covid vaccine really affect your period? Here’s what our study found

In January 2021, my colleagues at the hospital were among the first to receive the Covid-19 vaccine. Comparing the side-effects afterwards, most of us had a sore arm, some of us felt feverish and generally under the weather, but one comment stood out. “My period was heavier than usual,” said one of the midwives. “But that happens to me every year after we get our flu vaccines, too. It’s just another of those vaccine side-effects, isn’t it?” Was it? I’m an immunologist working in female reproduction and this was the first time I had heard of such an effect, but it didn’t strike me as implausible. We know that various stressors, physical and psychological, can influence the menstrual cycle and vaccination is certainly a physical stressor; those of us who were complaining of feeling under the weather could attest to that. And yet I wondered why, if this effect was as run of the mill as my colleague seemed to think, it wasn’t something I had heard before.
27th Jul 2022 - The Guardian

Covid-19 antibody levels jump among oldest age groups after spring booster jabs

Covid-19 antibody levels among the oldest age groups have jumped sharply in recent months, following the rollout of spring booster jabs, new figures suggest. Some 94.3% of people aged 80 and over in England were likely to have antibodies at the start of July, up from 65.8% at the end of March. Among 75- to 79-year-olds, the proportion stands at 93.1%, up from 62.8%. The figures have been calculated by the Office for National Statistics (ONS) and use a higher threshold for measuring antibodies than in previous studies, in order to better reflect the proportion of people with the strongest possible antibody response to infection.
27th Jul 2022 - The Independent

The Earliest Known Cases of COVID-19 Have Finally Been Pinpointed

Wild animals sold on the southwestern side of the Huanan Seafood Wholesale Market in Wuhan were the most likely source of the COVID-19 outbreak, a team of 18 international scientists claim. While there's still no 'smoking gun', it seems there is a mountain of circumstantial evidence that would be very statistically unlikely to exist without the Wuhan markets at the epicenter of the outbreak. According to a 2021 World Health Organisation (WHO) mission report, a total of 174 people caught SARS-CoV-2 in the very early days of the outbreak in December 2019. Locations of where 155 of those people lived and worked were able to be extracted from the report. In their study published in Science, the international team of researchers found that the majority of these 155 people lived near the west bank of the Yangtze River, where the Wuhan markets are located. There was a high density of cases surrounding the market.
27th Jul 2022 - Science Alert

Pfizer starts mid-stage trial for vaccine against Omicron subvariant

Pfizer Inc and its German partner BioNTech SE said on Wednesday they had started a mid-stage study of a modified COVID-19 vaccine which targets both the original as well as the BA.2 Omicron subvariant. Pfizer said the vaccine is in an initial proof-of-concept study to gather more data. Together, the BA.4 and BA.5 subvariants are estimated to make up nearly 95% of the circulating coronavirus variants in the United States for the week ended July 23.
27th Jul 2022 - Reuters

FDA Clears Danish Monkeypox Vaccine Plant, Paving Way for Use of Doses in U.S.

The Food and Drug Administration signed off on a Bavarian Nordic A/S monkeypox vaccine plant, a move that allows use in the U.S. of 786,000 doses made at the facility in Denmark. The FDA said Wednesday it had validated the quality of the shots made at the plant and they met the agency’s standards. “This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox,” Health and Human Services Secretary Xavier Becerra said. Health authorities seeking to vaccinate people at high risk of monkeypox have been waiting for the shots. The federal government had allowed the 786,000 doses to be shipped to the U.S. in advance to speed their availability once the FDA cleared the plant.
27th Jul 2022 - The Wall Street Journal

CDC to make monkeypox nationally notifiable condition

The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.
27th Jul 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Jul 2022

View this newsletter in full

U.S. Leads Globally in Known Monkeypox Cases, CDC Says

The U.S. has reported about 3,600 confirmed or suspected monkeypox cases, federal data showed, while vaulting near the top of the list of countries with the most known infections since the onset of the global health emergency. The rise in cases comes as the U.S. expands testing capacity, broadening the ability to spot new infections, but also as the global outbreak continues to grow. Some public-health experts said rising transmission heightens the chances a broader population will face the risk of infections as the opportunity to slow and potentially stop the outbreak is fading. Data have shown the outbreak is heavily concentrated among men who have sex with men, as the virus exploits social networks among people in close contact. This is already a concern, but spreading more broadly means the potential added challenge of trying to educate and protect a broader population, health experts said.
26th Jul 2022 - The Wall Street Journal

Monkeypox Proves Elusive Foe as WHO Sounds Alarm on Global Spread

The Covid-19 outbreak forced governments around the world to revamp their pandemic response programs, invest in drugs and vaccines and establish viral surveillance systems. Now monkeypox is putting those upgrades to the test -- and they’re falling short. Getting out in front of the global flare-up of the monkeypox virus, which has spread to about 16,000 people in more than 70 countries in just a few months, is an achievable goal, according to infectious disease experts. Yet the lack of urgency and coordination in testing and treatment in many parts of the world has prompted the World Health Organization to sound the alarm.
26th Jul 2022 - Bloomberg

Novavax Announces Expanded Approval of Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 through 17 in Japan

Novavax, Inc, a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Nuvaxovid™ COVID-19 vaccine received expanded manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for primary immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17. Novavax has partnered with Takeda to develop, manufacture, and distribute Nuvaxovid in Japan.
26th Jul 2022 - The Associated Press

How COVID-19 lockdown measures — and their outcomes — varied in cities around the world

During the COVID-19 pandemic, Chinese cities have repeatedly imposed lockdowns following their central government’s stubborn pursuit of Zero-COVID. But lockdowns weren’t limited to authoritarian regimes such as China. Many democracies also imposed some form of lockdowns to curb the virus transmission. How effective were they? Was it worth it? And who was the most adversely affected? These are meaningful questions to reflect on, especially as drastic COVID-19 measures have been lifted as the severity of the virus’s impact has waned.
26th Jul 2022 - The Conversation Indonesia

COVID-19 antivirals may cut risk of hospitalization, death

McMaster University researchers in Ontario led the systematic review and network meta-analysis of 40 randomized clinical trials that included 17,563 patients comparing the effectiveness of 16 different antiviral drugs or drug combinations, including molnupiravir, nirmatrelvir-ritonavir (Paxlovid), and remdesivir, with standard care or a placebo in adults with non-severe COVID-19 up to Apr 25, 2022. The researchers noted that most antiviral trials to date have included hospitalized patients with severe or critical disease rather than those with milder illnesses. "Furthermore, although efficacy data from trials of molnupiravir, nirmatrelvir–ritonavir and remdesivir are promising, no head-to-head trials have compared these drugs," they wrote. "This is particularly important as health care systems attempt to prioritize access to effective COVID-19 treatments in the early stages of the disease."
26th Jul 2022 - CIDRAP

Diabetes risk remains elevated three months after COVID-19 infection

The risk of diabetes after infection with Covid-19 remains high for at least three months before declining to background levels. The diabetes risk from infection after acute infection also raises the risk on adverse sequlae as shown by increased used of several therapeutic agents such as pain medication, antidepressants, anxiolytics and oral hypoglycaemic agents.
26th Jul 2022 - Hospital Healthcare Europe

Novavax COVID-19 vaccine: When will it be available in the US?

Earlier this month, the Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for the Novavax COVID-19 vaccine. Research shows Novavax to be 100% effective in preventing moderate to severe COVID-19. Novavax uses a traditional vaccine model used previously for influenza and shingles vaccines. The United States Department of Health and Human Services has secured 3.2 million doses of Novavax for distribution in the U.S., with ordering opening to medical professionals in the coming weeks.
26th Jul 2022 - Medical News Today

BioNTech, Pfizer ask U.S. court for clearance over patent dispute with CureVac

COVID-19 vaccine maker BioNTech said on Tuesday that it and partner Pfizer have filed a complaint with the U.S. District Court in Massachusetts, seeking a judgment that they did not infringe U.S. patents held by rival CureVac. Reporting by Ludwig Burger and Blake Brittain Editing by David Bario and Mark Potter
26th Jul 2022 - Reuters

Monkeypox Vaccine Maker Bavarian Nordic Considers 24-Hour Emergency Production

Bavarian Nordic A/S, the only company with a vaccine approved for monkeypox, said it’s preparing to run production through the night to meet surging demand after the virus outbreak was declared a global emergency. The flare-up of monkeypox, which has spread to about 16,000 people in more than 70 countries in just a few months, was declared a public-health emergency of international concern by the head of the World Health Organization over the weekend. This is the highest level of alert that aims to marshal more resources globally to curb the outbreak and is the first such ruling since coronavirus started sweeping around the world.
26th Jul 2022 - Bloomberg

Pandemic Drinking Led to Thousands of UK Hospital Admissions, Deaths

Increased drinking fuelled by the pandemic could lead to thousands of extra hospital admissions, deaths and cases of disease over the next 20 years, experts have warned. A new study commissioned by NHS England from the University of Sheffield found that while lighter drinkers cut their consumption during the pandemic, heavier drinkers drank more and may never return to where they were. Experts found that 25 to 34-year-olds who were drinking at risky levels before the pandemic were the most likely to increase their drinking when Covid-19 hit.
26th Jul 2022 - Bloomberg

Mysterious Hepatitis Cases in Children May Have Complex Cause

An international effort to find the cause of mysterious hepatitis cases among children in dozens of countries yielded a new hypothesis on Monday, with research now suggesting that the cases were caused by a pair of viruses working in concert to trigger the liver inflammation in children with a certain genetic susceptibility. Between last October and July 8, 1,010 probable cases of unexplained hepatitis in children occurred in 35 countries, including the U.S., according to the World Health Organization. The cases can’t be explained by the familiar causes of hepatitis, including hepatitis viruses, excessive alcohol consumption or an overdose of the over-the-counter pain medicine acetaminophen.
26th Jul 2022 - The Wall Street Journal

Getting Around After the Pandemic Will Be a Shared Exercise

The report concludes that consumers’ mobility demands are evolving in seemingly contradictory ways. On one hand, people want inexpensive options, but on the other, the pandemic accelerated a shift away from mass transit, which is the cheapest service available. Ultimately, consumers want agile, on‑demand, and affordable transportation, which creates challenges that are difficult to reconcile. In that environment, new players will struggle to make money as they try to fulfill these demands.
26th Jul 2022 - Bloomberg

Feds look ahead to next-generation COVID vaccines

The White House tomorrow will host a summit on the future of COVID-19 vaccines, which will be streamed online. One of the main topics is speeding development of a more broadly protective COVID-19 vaccine. The Food and Drug Administration (FDA) vaccine advisory group recently recommended a bivalent booster shot that includes the original SARS-CoV-2 strain and an Omicron variant, and at the meeting, several members aired concerns that officials will more frequently face the challenge of tweaking the vaccine to keep up with the quickly evolving virus. At the global level, researchers are working on a roadmap for developing a new coronavirus vaccine to broadly protect against the most dangerous ones.
26th Jul 2022 - CIDRAP

Pfizer, BioNTech rebuff CureVac's 'groundless' patent infringement claims against COVID-19 shot Comirnaty

Pfizer and BioNTech aren’t playing sitting duck in the COVID-19 vaccine patent litigation that German mRNA specialist CureVac has brought. After joining forces to develop the massively successful COVID shot, Comirnaty, Pfizer and BioNTech are now facing what they call “threats of a groundless patent infringement suit by a company, CureVac, who has been unable to bring to market any product to help in the fight against COVID-19,” the partners said in a complaint filed Monday in the U.S. District Court for the District of Massachusetts. Pfizer and BioNTech allege there is “an actual, immediate, substantial and justiciable controversy” at play over whether Comirnaty has infringed or will infringe the trio of patents covered in CureVac’s lawsuit. Now, the partners want the Massachusetts court to rule against the infringement charges and prevent CureVac from pursuing further infringement claims, according to the court filings.
26th Jul 2022 - FiercePharma

‘There’s no one long Covid’: Experts struggle to make sense of the continuing mystery

Robert Gallo apologized for still coughing. The day before President Biden tested positive for Covid-19, the famed HIV researcher said he was still recovering from a Covid infection that had left him unable to walk, put him in the hospital, and made him delusional, he said Wednesday during a roundtable discussion about long Covid. Presented by the Global Virus Network, a coalition of leading virologists, the two-day virtual conference convened experts across disciplines and around the world to ask and answer questions about what causes long Covid, how to predict who gets it, how to treat it, and just possibly how to prevent it. No one has the answers, but Gallo, who co-founded the group and is also director of the Institute of Human Virology at the University of Maryland School of Medicine, puts his money on the amount of virus present right from the start.
26th Jul 2022 - Stat News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Jul 2022

View this newsletter in full

TGA provisionally approves COVID-19 vaccine, Nuvaxovid, for use in 12-17 year olds

Australia’s Therapeutic Goods Administration (TGA) has provisionally approved the Biocelect - on behalf of US biotech Novavax (Nasdaq: NVAX) - COVID-19 vaccine, Nuvaxovid, for use in individuals aged 12-17 years. The decision follows provisional approvals on 19 January 2022 for the use of Nuvaxovid in adults, on June 9, 2022, the Nuvaxovid booster dose for use in adults. As with adults, the vaccine should be administered in adolescents intramuscularly…
25th Jul 2022 - The Pharma Letter

Are We Getting Closer to a Potential Universal Coronavirus Monoclonal Therapeutic?

A research team reports discovering a neutralizing monoclonal antibody that it says has the potential to become a universal coronavirus therapy against SARS-CoV-2 and all its variants of concern, including Beta, Gamma, Delta, Epsilon and Omicron. In multiple animal models, the mAb shows effectiveness against the SARS-CoV, the Severe Acute Respiratory Syndrome that emerged in China in 2002, and MERS-CoV, the Middle East Respiratory Syndrome that appeared in Saudi Arabia in 2012, according to the scientists, who had that it also shows effectiveness against several common cold coronaviruses.
25th Jul 2022 - Genetic Engineering & Biotechnology News

The dominant BA.5 variant of Covid-19 signals we’re still not in the clear

Tracking BA.5’s rise is complicated somewhat because of an increase in at-home rapid testing to confirm infection, rather than testing in a clinical setting, which would make its way to health authorities and paint a fuller picture of the data. While the number of cases is nowhere near the level of infections due to omicron last winter, the week-on-week total of hospital admissions overall has trended up steadily over the past month, according to data from the Centers for Disease Control and Prevention.
25th Jul 2022 - Vox.com

New RT-PCR platform gives results faster than other COVID-19 tests on the market

Researchers at Columbia Engineering and Rover Diagnostics announced today that they have built an RT-PCR platform that gives results in 23 minutes that match the longer laboratory-based tests--faster than other PCR tests on the market. It can be adapted to test for a broad range of infectious diseases including not just COVID-19 but also flu, strep, and other viruses that require fast diagnosis. Its targeted sensitivity is higher than other types of tests such as isothermal, antigen, and CRISPR. And, at just two pounds, the Rover PCR is easy to carry around and can be used by anyone.
25th Jul 2022 - News-Medical.Net

Think You’ve Never Had Covid-19? Think Again.

Charley Ding spent weeks early in the pandemic intubating patients sick with Covid-19. The 42-year-old anesthesiologist in South Barrington, Ill., said he has since watched most of the doctors and nurses he works with get infected at some point. But he has never gotten Covid-19, he said. “It’s probably a combination of being careful, maybe being blessed with a good immune system,” he said. “But also just luck.” Dr. Ding is a member of a shrinking club of people who are pretty sure they have never been infected with SARS-CoV-2, the virus that causes Covid-19. Geneticists and immunologists are studying factors that might protect people from infection, and learning why some are predisposed to more severe Covid-19 disease.
25th Jul 2022 - The Wall Street Journal

China approves Genuine Biotech's HIV drug for COVID patients

China on Monday gave conditional approval to domestic firm Genuine Biotech's Azvudine pill to treat certain adult patients with COVID-19, adding another oral treatment option against the coronavirus. The availability of effective COVID vaccines and treatments is crucial in laying the groundwork for China's potential pivoting from its "dynamic COVID zero" policy, which aims to eliminate every outbreak - however small - and relies on mass testing and strict quarantining.
25th Jul 2022 - Reuters

COVID reinfections appear to be surging in the latest Omicron wave. Here's what we know

When Lyndall Heather caught COVID-19 for a third time this year, she initially didn't believe she had it. Just six weeks on from her second COVID infection, the Darwin nurse was well within the immune period that precluded her from testing. "I just thought it's pretty unlikely, it's probably just the cold," she said. But after becoming seriously unwell, she went for a PCR test and found out she had contracted a separate COVID-19 infection. "Even my manager found it confusing. I guess things are constantly changing," Ms Heather said. Hampered by long COVID symptoms like fatigue and brain fog, Ms Heather said her latest reinfection has left her anxious for the future.
25th Jul 2022 - ABC News

Covid-19: Building immunity against virus will take years - expert

It could take years before our immune systems build up defences against the ever-changing virus that causes Covid-19 – but an immunologist is optimistic we'll soon have a much smarter booster to fight it.
25th Jul 2022 - New Zealand Herald

Commentary: No cause for alarm over 'Centaurus', the new Omicron subvariant BA.2.75

Should we be worried about the new Omicron subvariant BA.2.75? There is no clear evidence "Centaurus" evades the immune system significantly or spreads more quickly for now, but what we do know suggests it would likely fizzle out like Alpha and Delta, says this virologist.
25th Jul 2022 - CNA

Scientists identify how the coronavirus spike protein causes heart damage

The new research has found that the SARS-CoV-2 coronavirus spike protein is capable of causing heart muscle injury through the inflammatory process, setting it apart from previously known coronaviruses. The good news is that the preliminary research suggests the damage caused by the process, which is part of the heart muscle cells' "own natural immune machinery" can be reduced by vaccination. Research published in 2020 discovered abnormal changes to the way the heart was pumping in 55% of hospitalised patients, with around one in seven showing evidence of severe dysfunction.
25th Jul 2022 - Sky News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Jul 2022

View this newsletter in full

Shanghai districts face mass COVID testing round during July 26-28

Shanghai ordered residents across nine of the city's districts and some smaller areas to do COVID-19 tests over July 26-28, the city government said on Monday, as sporadic local cases kept emerging in the Chinese commercial hub. Shanghai lifted a two-month lockdown in June but has registered double-digits daily cases in recent weeks. Officials rely on repeated mass testing rounds to identify infections they quickly quarantine to prevent further spread, in line with China's "dynamic zero" strategy that demands each flare-up be contained as quickly as possible.
24th Jul 2022 - Reuters

Monkeypox 'Can Be Contained' in US, White House Doctor Says

Monkeypox “can be contained” in the US, with the goal of eventually eliminating the illness as testing and vaccinations ramp up, the White House’s Covid-19 response coordinator said. Ashish Jha repeated that, with more than 2,000 cases nationwide, the US Department of Health and Human Services is weighing whether to declare monkeypox a public health emergency. On Saturday, the head of the World Health Organization declared the global outbreak a public health emergency of international concern. “We think we can get our arms around this thing,” Jha said in an interview with CBS’s “Face the Nation” on Sunday. “But obviously, if we need further tools, we will invoke them as we need them.”
24th Jul 2022 - Bloomberg

WHO Chief Overrules Panel to Declare Monkeypox Global Emergency

The monkeypox outbreak is a public health emergency of international concern, the head of the World Health Organization said, overruling a divided expert panel to issue the group’s highest alert. The move paves the way for stepped-up global cooperation to stop the virus, which has spread to dozens of countries. The last time the WHO made a similar declaration was during the early stages of the Covid-19 outbreak in January 2020. US Health and Human Services Secretary Xavier Becerra called the WHO decision “a call to action for the global health community.” President Joe Biden’s administration has made vaccines, testing and treatments available and is “determined to accelerate our response in the days ahead,” he said in a statement.
24th Jul 2022 - Bloomberg

COVID: Is the virus getting smarter?

Coronavirus infections are surging as the virus evolves, becoming "too clever", according to the World Health Organisation's special envoy on COVID-19, David Nabarro. With figures suggesting nearly three million people in the UK are still unvaccinated, what can be done to encourage those people to get their jabs, and is the virus becoming too smart for our vaccines to keep up? On the Sky News Daily with Niall Paterson, the WHO's Mr Nabarro explains why it's still important to keep protected from coronavirus, and vaccination champion Wendy Francis-White shares her experience helping to get jabs in the arms of those who are vaccine hesitant.
24th Jul 2022 - Sky News

Two symptoms that mean you should 'assume you have Covid', professor says

Article reports that a professor has warned people over two symptoms that probably mean they have Covid. With free tests stopped for the majority in April, it is harder for people to spot they have the virus. Omicron BA.5 is now the dominant Covid strain, accounting for approximately 79% of UK cases as of July 18. Professor Tim Spector, who heads up the ZOE Health Study, said people should assume they do have coronavirus if they wake up with a sore throat and fatigue, despite getting a good night's sleep, The Mirror reports. Professor Spector tweeted: "Twice as many covid cases as common colds currently- the ratio has never been so high. Symptoms much the same except generally more fatigue and sore throat - so best to assume it’s Covid!
23rd Jul 2022 - Birmingham Live

COVID Virus May Tunnel through Nanotubes from Nose to Brain

SARS-CoV-2, though, may have come up with an ingenious work-around. It may completely do away with the molecular maneuverings needed to attach to and unlock a cell membrane. Instead it wields a blunt instrument in the form of nanotube “bridges”—cylinders constructed of the common protein actin that are no more than a few tens of nanometers in diameter. These tunneling nanotubes extend across cell-to-cell gaps to penetrate a neighbor and give viral particles a direct route into COVID-impervious tissue. Researchers at the Pasteur Institute in Paris demonstrated the prospects for a nanotube-mediated cell crossing in a study in a lab dish that now needs to be confirmed in infected human patients.
23rd Jul 2022 - Scientific American

Children who suffer four symptoms could develop Long Covid, study finds

Children who show at least four symptoms are most at risk of suffering from Long Covid, according to new research. The international study found the most common symptoms to be fatigue or weakness, cough, difficulty breathing or shortness of breath. Researchers also found hospitalisations for 48 or more hours and being aged 14 or older are other aggravating factors. These findings could help identify vulnerable individuals who are more susceptible to Long Covid. Lead author Professor Stephen Freedman of the University of Calgary, Alberta, Canada, explained: "We found in some children, illness with Covid-19 is associated with reporting persistent symptoms after three months. Our results suggest appropriate guidance and follow-up are needed, especially for children at high risk for Long Covid."
23rd Jul 2022 - Daily Record

There's a new COVID-19 Omicron subvariant, so what is BA.2.75 and why are some people calling it 'Centaurus'?

Since the COVID-19 pandemic first began, many have become desensitised to these next few words: There's a new Omicron subvariant. BA.2.75 was first detected in India in early May. Since then, it's been found in Europe and the United States. The chief scientist with the World Health Organization (WHO), Soumya Swaminathan, said BA.2.75 appeared to have mutated in a way that could indicate "major immune escape". However, Dr Swaminathan says there isn't enough data to know how severe its impact will be. Here's what we know so far:
23rd Jul 2022 - ABC News

WHO Declares Monkeypox a Global Health Emergency

The World Health Organization has declared that monkeypox is a public-health emergency of international concern as global case numbers surpass 16,000. This is the first time the WHO has declared a global health emergency since the start of the Covid-19 pandemic in January 2020. The WHO’s director-general, Dr. Tedros Adhanom Ghebreyesus, said the emergency committee believes the risk is moderate globally, except in the European region where it assesses the risk as high.
23rd Jul 2022 - The Wall Street Journal

‘Covid is not going to go away’: Australia will require public health measures for foreseeable future, say experts

In May 2021, Australia’s chief medical officer, Prof Paul Kelly, described how Covid vaccines were our “ticket out of the pandemic”. Vaccination, he said, would give Australians “a life with more certainty”. More than one year later, Australia’s Covid-19 vaccination rate is among the highest in the world. Yet daily deaths from the virus remain in the double-digits. Hospitals are overwhelmed, aged care homes and the most vulnerable are struggling with outbreaks, and there is again debate about whether more social restrictions, including mask mandates, are needed to curb virus spread. Infectious diseases expert and director of the Doherty Institute, Prof Sharon Lewin, said: “Last year, I definitely did not think we would be in this position.”
22nd Jul 2022 - The Guardian

New study estimates how many children will get long Covid

An international study estimates the prevalence of long Covid in children to be anywhere from 5% to 10% — a figure that's far lower than estimates of long Covid in more than a third of adults. The findings, published Friday in the journal JAMA Network Open, also suggested that several factors could predict which children with Covid may have ongoing symptoms or develop new ones in the 90 days following infection. Those include having seven or more symptoms during the initial phase of illness and hospitalization for more than two days. Age was also a factor: Long-term symptoms were more prevalent in children 14 years and older.
22nd Jul 2022 - NBC News

WHO Prioritizes Health Care Workers And Older Populations in Latest COVID-19 Vaccination Strategy Update

After missing the target to vaccinate 70% of people in every country against COVID by July 2022, WHO’s new vaccine strategy prioritises 100% coverage for health workers and older people – but admits that every country will have to decide for itself. The World Health Organization has published an update to the Global COVID-19 Vaccination Strategy that preserves its 70% global vaccination target and 100% vaccination targets for health care workers and older populations, but acknowledges that countries will still need to determine their ‘context-specific targets’ for their own COVID-19 national vaccination programmes.
22nd Jul 2022 - Health Policy Watch

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Jul 2022

View this newsletter in full

Antigen tests show more than 20,000 new Covid infections per day

The country registered 23 more Covid-19 fatalities and 2,607 new cases admitted to hospital during the previous 24 hours, the Public Health Ministry announced on Thursday morning, but government data showed an average of more than 20,000 positive antigen tests over the past week.
21st Jul 2022 - Bangkok Post on MSN.com

COVID-19 Vaccine Linked to Short-Term Changes in Menstrual Cycle Length, Study Suggests

A new study shows that women may experience short-term changes in their menstrual cycles after COVID-19 vaccination. The researchers found that these changes were associated with all COVID-19 vaccine types.
21st Jul 2022 - Prevention

CDC endorses more traditional Novavax COVID shot for adults

U.S. adults who haven’t gotten any COVID-19 shots yet should consider a new option from Novavax -- a more traditional kind of vaccine, health officials said Tuesday. Regulators authorized the nation’s first so-called protein vaccine against COVID-19 last week, but the final hurdle was a recommendation from the Centers for Disease Control and Prevention. “If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Dr. Rochelle Walensky, CDC’s director, said in a statement, endorsing an earlier decision from an influential advisory panel.
21st Jul 2022 - Associated Press

COVID-19 tied to new-onset, short-term heart disease, diabetes

COVID-19 patients are six times more likely than uninfected people to develop cardiovascular disease (CVD) and nearly twice as likely to receive a new diabetes diagnosis, but the risk begins to recede at 5 weeks and 12 weeks, respectively, concludes a UK study published yesterday in PLOS Medicine.
20th Jul 2022 - CIDRAP

BLOOM Shionogi Covid Pill Xocova Fails to Win Japan Panel Backing

Shionogi & Co.’s experimental Covid-19 treatment Xocova failed to win the backing of health experts in Japan who said there wasn’t enough data to show the medicine’s efficacy. The panel members didn’t recommend that Japan’s health ministry authorize emergency use of the therapy as there was a need to continue discussion on it, Hiroshi Kiyota, chairman of the expert committee said in a briefing Wednesday. The health ministry relies on the panel’s decision to give the approval.
20th Jul 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Jul 2022

View this newsletter in full

With COVID and influenza on the rise, how worried should pregnant women be?

When Alix Mellor fell ill with COVID, she cycled through the full gambit of symptoms: coughing throughout the night, soaring temperatures and unforgiving physical fatigue. But it was the thing she couldn't feel that really made her worry. Days into the infection and 34 weeks pregnant, she noticed her baby was uncharacteristically still. "I called the midwives and they said to come into the hospital and they did some fetal monitoring to make sure the baby is OK," the Melbourne mother says. "It was in my mind that it's not just about me, it's about the baby." It was the second time in three weeks the Melbourne mother had found herself at the hospital with a respiratory illness. The first was with a nasty bout of influenza which saw her hospitalised for four days with a "really high pulse rate". Women who test positive for COVID while pregnant have a higher risk of hospitalisation and ventilation than those who aren't pregnant and are also at greater risk of premature birth and stillbirth. It's a similar situation for the flu, which can be deadly for expectant mothers.
20th Jul 2022 - ABC News

CDC endorses more traditional Novavax COVID shot for adults

Weekly tests dropped for unvaccinated state employees

Minnesota state government employees who are unvaccinated for COVID-19 are no longer required to take weekly tests for the virus in order to stay in the workplace. The requirement that went into effect in September 2021 meant thousands of employees took tests each week. Those that didn’t comply were subjected to suspensions or other discipline. A state official said the requirement was rescinded because of the evolving nature of the virus. “Whereas it was common to have broad, uniform precautionary measures earlier in the pandemic, the pandemic is at a point where public health COVID-19 risk assessments and precautions are now more dependent upon the specific circumstances of individuals and communities,” said Patrick Hogan, Department of Minnesota Management and Budget spokesman.
20th Jul 2022 - The Associated Press

As BA.5 Spreads, How Long Will a Prior Covid-19 Infection Protect You?

If you have had Covid-19, how long can you expect to be protected from another infection? Doctors say the window between infections might be shrinking, fueled in part by the immune-evading Omicron BA.5 subvariant, although researchers are still gathering data. The U.S. Centers for Disease Control and Prevention has long set 90 days as its window for what counts as a new Covid-19 infection—meaning that symptoms or positive Covid tests within 90 days of a prior infection have been considered the same infection. Getting reinfected sooner has always been possible but uncommon. Now, reinfections are happening more often and can occur closer in time, say infectious-disease specialists and epidemiologists. They cite the march of new subvariants emerging and circulating simultaneously as well as BA.5’s ability to evade immune protections. In addition, doctors note, people are taking fewer precautions, such as masking indoors or avoiding large gatherings.
20th Jul 2022 - The Wall Street Journal

Novavax Covid Shot for Adults Gains CDC Advisers' Backing

Novavax Inc.’s shares surged after its Covid-19 vaccine won backing from a panel of US public health advisers, a crucial step in providing officials with another tool against the virus as cases start to rise again. The 12-member panel of outside experts convened by the Centers for Disease Control and Prevention voted unanimously to recommend the shots for adults. CDC Director Rochelle Walensky signed off on the advice from the Advisory Committee on Immunization Practices, which allows the shot to finally go into arms. The stock gained 12% at the close of New York trading Tuesday.
20th Jul 2022 - Bloomberg

Shionogi Covid Pill Xocova Fails to Win Japan's Panel Backing

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Jul 2022

View this newsletter in full

More (mostly mild) side effects when flu vaccine given with COVID booster

Self-reported data from nearly 1 million Americans show an 8% to 11% higher rate of mostly mild systemic adverse events after simultaneous seasonal flu vaccine and mRNA COVID-19 booster (third) doses than with the COVID-19 booster alone. In the study, published today in JAMA Network Open, the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team and Emory University analyzed rates of systemic adverse events among 981,099 Americans aged 12 years and older in the week after either simultaneous flu and COVID-19 booster doses or the booster alone from Sep 22, 2021, to May 1, 2022. Volunteers responded to at least one health survey through the CDC's smartphone-based v-safe monitoring system during the study period.
17th Jul 2022 - Cidrap.umn.edu

A riskier approach to new vaccines will pay off

The UK has been hit by three consecutive waves of Omicron variants, each one appearing in a matter of weeks. If a future variant proves much more dangerous, we will not have much time to brace for impact. So what can be done? The answer: develop better vaccines. The simplest approach is, as with flu, to try to predict where the virus will be four to six months ahead, and to make booster doses accordingly. That looks feasible. After scaling up to meet demand for vaccines in 2021, the world has “unprecedented production capacity”, says Rasmus Bech Hansen, founder of Airfinity, a health analytics company — enough to produce another 8bn doses this year. But better, if we can figure out how to do it, is to make a vaccine that targets all Sars-Cov-2 variants, or a wider family of coronaviruses including Sars or, even more ambitiously, all coronaviruses.
15th Jul 2022 - Financial Times

COVID-19 has become 'too clever for us' and can 'break past' our protection, WHO official says

WHO special envoy David Nabarro told Sky News on Thursday that the reason for a surge in new COVID-19 cases globally is because the virus "changed yet again, and it's become too clever for us." "This virus is capable of constantly evolving and changing," he told the outlet. "It can break past our immune defenses, and that's why the numbers are going up." Nabarro told Sky that taking precautions against the virus, like ensuring people are up to date on their COVID-19 vaccination shots, is still important to keep others safe.
15th Jul 2022 - Business Insider on MSN.com

FDA delays decision on BeiGene's cancer drug on China COVID curbs

China-based drug developer BeiGene said on Thursday the U.S. Food and Drug Administration has delayed a decision on its cancer drug as COVID-19 curbs in the country prevented the regulator from conducting inspections. The FDA was expected to decide on the drug, tislelizumab, by July 12 but has now delayed its move until the inspections are complete, the company said. The delay makes BeiGene the latest China-based company for which the FDA has cited pandemic travel restrictions as an issue following similar problems with Hutchmed Ltd , as well as U.S.-based Coherus BioSciences Inc (CHRS.O) and its Chinese partner Shanghai Junshi Biosciences Co Ltd
15th Jul 2022 - Reuters

Pfizer, Biontech seek Japan regulatory approval of COVID shot for young children

Pfizer Inc and BioNTech SE have sought approval from Japan's health ministry for use of their COVID-19 vaccine for use in children aged six months to four years, the companies said in a statement on Thursday. The filing follows approval last month by U.S. regulators for Moderna Inc's two-dose vaccine and the Pfizer-BioNTech three-shot regimen for children in the same age group.
15th Jul 2022 - Reuters

Canada clears Moderna's COVID vaccine for children under 5

Canada on Thursday authorized Moderna Inc's COVID-19 vaccine for babies as young as 6 months old, making it the country's first vaccine against coronavirus for children under 5, Health Canada said. Canada had been offering Moderna's Spikevax vaccine to children above 5 since March, and the latest authorization means some 1.7 million more children are now eligible for inoculation against COVID, according to Health Canada.
15th Jul 2022 - Reuters

EU adds severe allergies as side effect of Novavax COVID vaccine

The European Medicines Agency on Thursday identified severe allergic reactions as potential side effects of Novavax Inc's (NVAX.O) COVID-19 vaccine. The vaccine was authorized by U.S. regulators on Wednesday, and its product label in the United States warns against administering the shot to people with a history of allergic reactions to any components of the shot. Shares of Novavax fell 20.3% to $55.72 in morning trading, along with the broader market and other COVID-19 vaccine makers. Novavax shares are usually volatile.
15th Jul 2022 - Reuters

From AstraZeneca to Novavax: Serum Institute wins FDA nod to supply new COVID shot to US from India

With an FDA authorization for Novavax’s Nuvaxovid, Serum Institute of India (SII) has scored the go-ahead to finally supply a COVID-19 vaccine to the U.S. Wednesday’s emergency use authorization for Novavax’s recombinant protein-based vaccine means SII is able to supply the shot, also known as Covovax, to the U.S. from India. SII has been producing AstraZeneca’s Vaxzevria, but that adenovirus-vectored vaccine isn’t available in the U.S. The Novavax green light now makes SII the first Indian drugmaker to produce a COVID shot for the U.S. market.
15th Jul 2022 - FiercePharma

UK weekly COVID-19 infections rise, booster jab programme announced

An estimated 3.5 million people in Britain had COVID-19 in the latest week of available data, the Office for National Statistics (ONS) said on Friday, up nearly 30% on the 2.7 million recorded in the previous week. Separately, the government announced that a new COVID booster jab programme would begin later this year. "The percentage of people testing positive for coronavirus (COVID-19) continued to increase across the UK," the ONS said. "These increases were likely caused by increases in infections compatible with Omicron variants BA.4 and BA.5."
15th Jul 2022 - Reuters

FDA green-lights Novavax vaccine as COVID-19 levels rise

The FDA's approval allows distribution of the vaccine to begin, but before health providers can administer it, the Centers for Disease Control and Prevention (CDC) must recommend it. The CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to discuss the topic on Jul 19. In its announcement, the FDA said the vaccine is approved for use as a two-dose primary series in adults (ages 18 and older). The vaccine is made on a more traditional platform, which officials hope will sway more people to become immunized. The vaccine contains the SARS-CoV-2 spike protein produced in insect calls and contains the Matrix-M adjuvant as an immune booster. The FDA's announcement yesterday came more than a month after its vaccine advisory board recommended EUA approval. Earlier this week, the Biden administration announced the purchase of 3.2 million Novavax doses.
14th Jul 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Jul 2022

View this newsletter in full

Health Canada approves first COVID-19 vaccine for youngest kids

Canada's drug regulator approved Moderna's COVID-19 vaccine for infants and preschoolers Thursday, making it the first vaccine approved for that age group in the country. Health Canada now says the Moderna vaccine can be given to young children between the ages of six months and five years old in doses one-quarter the size of that approved for adults. “After a thorough and independent scientific review of the evidence, the department has determined that the vaccine is safe and effective at preventing COVID-19 in children between 6 months and 5 years of age,” the department said in a statement.
14th Jul 2022 - CTV News

Alnylam accuses Pfizer, Moderna of infringing a second patent

Alnylam is adding more fuel to the fire in its infringement lawsuits against Pfizer and Moderna, claiming both companies violated a patent that was just granted to the company on Tuesday. The fight is over mRNA technology Pfizer and Moderna used in developing their respective COVID-19 vaccines, Alnylam says. Alnylam originally filed lawsuits against each in March. On Tuesday in lawsuits filed in U.S. district court in Delaware, Alnylam said that its newly granted patent covers a specific class of lipid nanoparticles (LNPs) and how they are manufactured. LPLs deliver genetic material into cells.
14th Jul 2022 - FiercePharma

FDA delays decision on BeiGene's cancer drug on China COVID curbs

China-based drug developer BeiGene said on Thursday the U.S. Food and Drug Administration (FDA) has delayed a decision on its cancer drug as COVID-19 curbs in the country prevented the regulator from conducting inspections. The FDA was expected to decide on the drug, tislelizumab, by July 12 but has now delayed its move until the inspections are complete, the company said. The delay makes BeiGene the latest China-based company for which the FDA has cited pandemic travel restrictions as an issue following similar problems with Hutchmed Ltd , as well as U.S.-based Coherus BioSciences Inc and its Chinese partner Shanghai Junshi Biosciences Co Ltd
14th Jul 2022 - Reuters

AstraZeneca says COVID vaccine as effective as mRNA shots in review

AstraZeneca said on Wednesday a review of real-world data showed its COVID-19 vaccine provided equally effective protection against hospitalisation and death after two doses as with current mRNA shots from Pfizer and Moderna
14th Jul 2022 - Reuters

Pfizer, Biontech seek Japan regulatory approval of COVID shot for young children

WHO Panel Advises Against Generic Antidepressant to Treat Covid

A generic antidepressant and a gout medicine that garnered some popularity as Covid-19 treatments shouldn’t be used for mild infection because there’s no evidence they help, according to a panel of experts advising the World Health Organization. The drugs, fluvoxamine and colchicine, could potentially cause harm, the group of experts said in the BMJ medical journal Thursday. The panel didn’t give advice for severe illness, saying there was a lack of data.
14th Jul 2022 - Bloomberg

How long after exposure you can test positive and early signs to look for

Covid rates are continuing to increase, and more and more people are testing positive across the UK. The Zoe Health Study produced data this week showing that there were over 350,000 daily Covid cases – a new record for the UK. Professor Tim Spector, Zoe scientific co-founder and lead scientist on the Zoe Health Study, said: “Covid is still rampant in the population. “So much so that if you have any cold-like symptoms at the moment it’s nearly twice as likely to be Covid as a cold. “Even if people have had a past infection and are fully vaccinated, people are still catching it.” Here’s everything you need to know about how quickly you will show symptoms.
14th Jul 2022 - iNews

Study: Kids have stronger COVID-19 antibody response than adults

A new prospective study of 252 families with members diagnosed as having mild COVID-19 in Italy finds that, while all age-groups had detectable SARS-CoV-2 antibodies up to 1 year after infection, children—especially those younger than 3 years—had higher antibody levels than adults at all intervals tested. In the study, published today in JAMA Network Open, a team led by University of Padua researchers enrolled 902 unvaccinated patients at a COVID follow-up clinic from Apr 1, 2020, to Aug 31, 2021. Families were included in the study if they had children younger than 15 years and at least one member who had tested positive for COVID-19 at least 4 weeks earlier.
13th Jul 2022 - CIDRAP

Novavax, at long last, clinches FDA emergency nod for protein-based COVID shot

The U.S. FDA gave the all-clear to Novavax’s adjuvanted, protein-based shot, teeing up the nation’s fourth pandemic prophylactic behind those from Pfizer-BioNTech, Moderna and Johnson & Johnson. The FDA’s emergency use authorization covers the prevention of COVID-19 caused by SARS-CoV-2 among adults ages 18 and up. The company aims to file a full biologics license application by year-end and figures it will be the last COVID vaccine player blessed with an emergency nod, Novavax’s John Trizzino, executive vice president, chief commercial officer and chief business officer, told Fierce Biotech at this year’s BIO International Convention.
13th Jul 2022 - Fierce Pharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Jul 2022

View this newsletter in full

FDA Authorizes Novavax’s Covid-19 Vaccine

U.S. health regulators have authorized the use of Novavax Inc.’s Covid-19 vaccine, providing a new option that works differently than the two leading vaccines, but at a time when overall demand for vaccines and boosters is low. The Food and Drug Administration said Wednesday that adults 18 years and older may receive Novavax’s vaccine. The Novavax vaccine, given as two doses three weeks apart, could become available soon if the Centers for Disease Control and Prevention signs off in the coming days. The authorization gives adults “another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency-use authorization,” FDA Commissioner Robert M. Califf said.
14th Jul 2022 - The Wall Street Journal

Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines

AstraZeneca’s (AZ) COVID-19 vaccine, Vaxzevria, and the available mRNA COVID-19 vaccines provide ‘equally effective’ protection against hospitalisation and death, an expert review of data from 79 real-world studies has revealed. Infectious disease experts from Asia reviewed data from the VIEW-hub database on vaccine use and impact, developed by John Hopkins Bloomberg School of Public Health and the International Vaccine Access Center. The findings from the study were reported by Expert Review of Vaccines. The findings shows that Vaxzevria and the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines offer an ‘equivalent degree’ of protection against hospitalisation (91-93%) and death (91-93%) following two doses, regardless of age.
13th Jul 2022 - PMLiVE

Covid vaccine 66 per cent less effective at preventing infection than it was just two months ago, expert says

Covid cases have hit record levels in the UK, yet the vaccine is less effective at preventing infection than at any time since it was introduced, according to a leading virus modeller. The degree of protection a jab gives against getting a Covid infection has tumbled from about 30 per cent two months ago to about 10 per cent today, according to Professor Karl Friston, of University College London. This is largely because the new dominant Omicron subvariants, BA.4 and BA.5, are much better at evading immunity built up by vaccinations than their predecessor, BA.2, he says.
13th Jul 2022 - iNews

How long after catching Covid can you become reinfected and when should you get your booster?

People may become reinfected with Covid-19 as early as 28 days after recovering from the virus, according to the latest advice from the Australian Health Protection Principal Committee. Previously, reinfection was defined as a case occurring more than 12 weeks after an initial infection. The committee said the Omicron subvariants BA.4 and BA.5 “are associated with increased immune escape and we are likely to see rates of reinfection rise among those who have previously been infected with an earlier Covid-19 variant, and those who are up to date with their vaccinations”.
13th Jul 2022 - The Guardian

Covid-19: Researchers face wait for patient level data from Pfizer and Moderna vaccine trials

Independent researchers looking to obtain patient level data from the Pfizer and Moderna covid-19 vaccine trials may have to wait longer. In status reports filed recently with the US federal trials registry (clinicaltrials.gov) between February and May, both companies extended the dates by which the trials will be completed, Pfizer by nine months, from 15 May 2023 to 8 February 2024. Moderna’s expected completion date is delayed from 27 October to 29 December 2022. Pfizer indicated in its trial protocol that individual participant data would be made available two years after study completion.1 Now that the date has been pushed back, Pfizer will entertain and review requests “when the study is complete and all planned analyses have been performed,” said the company’s senior director of global media relations, Jerica Pitts. Luis Carlos Saiz, a researcher at the Innovation and Organisation Unit of the Navarre Regional Health Service, Spain, said that access to raw patient data was important for researchers because “it is key to build trust in health policies and to protect citizens from potential vested interests.”
13th Jul 2022 - The BMJ

Pfizer, Moderna COVID-19 vaccines infringe new Alnylam patent, lawsuits say

Alnylam Pharmaceuticals Inc escalated its patent fight with Pfizer Inc and Moderna Inc over their COVID-19 vaccines on Tuesday, accusing the companies in Delaware federal court of infringing a newly obtained patent. The lawsuits said the vaccines' messenger-RNA delivery systems violate an Alnylam patent on lipid nanoparticle (LNP) technology for delivering genetic material into human cells. The U.S. Patent and Trademark Office issued the patent the same day Alnylam filed the complaints.
13th Jul 2022 - Reuters

Adapted, two-strain vaccines to lift COVID protection - EU official

Adapted versions of established mRNA COVID-19 vaccines that address two variants in one shot will soon offer people better protection than vaccines that are now available, a European health official said on Wednesday. Moderna and the BioNTech-Pfizer alliance are working on vaccines based on a combination of the original Wuhan virus and an Omicron subvariant. Referred to as bivalent shots, these are planned for use in the autumn vaccination campaign.
13th Jul 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Jul 2022

View this newsletter in full

What is the long-term protection against COVID-19?

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is known to cause many clinical manifestations. The protection conferred by prior infection or vaccination against infection over the long term is poorly understood. A new paper in Immunological Reviews describes the immunologic parameters associated with protection from COVID-19.
12th Jul 2022 - News-Medical.Net

Australia's CSIRO develops machine learning tool that spots emerging COVID-19 variants

CSIRO did not mention how they developed the AI tool called VariantSpark but it was used to analyse around 10,000 COVID-19 samples in a new study, whose findings were published in the peer-reviewed journal Computational and Structural Biotechnology Journal. The researchers worked with both Intel and ACT-based cloud system provider RONIN on the said study. According to a media release, VariantSpark can provide hourly updates, enabling the quick sharing of information with public health decision-makers and helping hospitals prepare for potential increases in admissions.
12th Jul 2022 - Healthcare IT News

Nitric oxide boosts oxygen in pregnant women with COVID-19 pneumonia

Inhaled high-dose nitric oxide (INO200) safely shortened time on supplemental oxygen and hospital stays among pregnant women diagnosed as having severe bilateral COVID-19 pneumonia, suggests a new study led by Massachusetts General Hospital (MGH) researchers. COVID-19 pneumonia is an especially dire diagnosis for pregnant women because it can rapidly lower oxygen in the blood and body tissues, requiring hospital admission and cardiopulmonary support, first author Carlo Valsecchi, MD, said in an MGH news release. "Pregnant women are three times more likely to need intensive care unit admission, mechanical ventilation, or advanced life support, and four times more likely to die," he said. "They also face a greater risk of obstetric complications such as preeclampsia, preterm delivery, and stillbirth."
12th Jul 2022 - CIDRAP

Development of a multiomics model for identification of predictive biomarkers for COVID-19 severity: a retrospective cohort study

COVID-19 is a multi-system disorder with high variability in clinical outcomes among patients who are admitted to hospital. Although some cytokines such as interleukin (IL)-6 are believed to be associated with severity, there are no early biomarkers that can reliably predict patients who are more likely to have adverse outcomes. Thus, it is crucial to discover predictive markers of serious complications.
12th Jul 2022 - The Lancet

White House urges COVID boosters to protect against spreading BA.5 subvariant

BA.5 is estimated to account for 65% of the coronavirus variants circulating in the United States as of last week, said Rochelle Walensky, the director of the U.S. Centers for Disease Control and Prevention (CDC). Officials urged people who are 50 years old or older to get a booster shot and said that would not prevent them from getting another "bivalent" booster designed to fend off Omicron more specifically later this year.
12th Jul 2022 - Reuters

Moderna unveils positive data on new booster candidate

Just a few weeks after the FDA recommended that COVID-19 vaccine manufactures tweak their boosters to zero in on the omicron BA.4 and BA.5 subvariants, Moderna has unveiled promising new data for its prospect. On Monday, the mRNA specialist said its omicron-containing bivalent booster elicited higher neutralizing antibody responses compared with the current booster. After one month, trial participants who received the bivalent booster had BA.4 and BA.5 neutralizing antibodies that were 1.69 times higher than those who received the original booster, the company said.
11th Jul 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Jul 2022

View this newsletter in full

Moderna Is Developing Two Different Omicron-Targeting Booster Shots

Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries. The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week. In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.
11th Jul 2022 - The Wall Street Journal

Future Covid Variants Can Be Predicted by AI, Startup Claims

As pharmaceutical companies struggle to keep up with the rapidly mutating coronavirus, a startup in Cambridge, Mass., says it can help them by using artificial intelligence to predict future variants. Apriori Bio models the ways a virus might change and predicts how it will behave. The company says it’s harnessing that information to design “variant-proof” vaccines and treatments that can fight current and future strains—and provide an early warning to governments, sort of like a hurricane alert, to guide the public-health response. After honing its technology, called Octavia, for more than two years, the fledgling company is formally launching with $50 million in funding from Flagship Pioneering Inc., the incubator behind Moderna Inc.
11th Jul 2022 - Bloomberg

Italy to start administering second COVID booster to over-60s

Italy will soon start its campaign to administer a second COVID-19 booster to everyone aged over 60, the health minister said on Monday, after receiving a green light from European Union health agencies.
11th Jul 2022 - Reuters

Moderna to advance two Omicron vaccine candidates against newer variants

Moderna Inc said on Monday it was advancing two Omicron vaccine candidates for the fall, one designed against the BA.1 variant and another against the BA.4 and BA.5. Vaccine makers including Moderna and rival Pfizer Inc are developing updated vaccines to target the fast-spreading Omicron subvariants BA.4 and BA.5, which have gained a foothold in the United States over recent weeks. Moderna said its decision to develop the bivalent vaccines was based on different market preferences for shots against the subvariants.
11th Jul 2022 - Reuters

US FDA approves Pfizer-BioNTech’s Covid-19 vaccine for adolescents

The US Food and Drug Administration (FDA) has granted approval for Pfizer and BioNTech’s Supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for adolescents aged 12 to 15 years. Earlier, the regulatory agency granted emergency use authorization (EUA) for the use of the vaccine in this age group and so far over nine million adolescents of this age have received the initial vaccine regimen. Comirnaty is the first Covid-19 vaccine to obtain FDA approval for use in adolescents. The FDA granted approval based on findings from a Phase III clinical trial in 2,260 subjects aged 12 to 15 years.
11th Jul 2022 - Pharmaceutical Technology

BioNTech, Pfizer ask EU to authorize 3-dose COVID-19 vaccine for kids over 6 months

BioNTech and Pfizer Friday announced they had submitted data to the European Medicines Agency backing their three-dose COVID-19 vaccine for children aged 6 months to less than 5 years. The announcement follows the U.S. Food and Drug Administration granting emergency use authorization for the same schedule in its youngest kids on June 17. The three-dose regimen includes a much lower dose than what's given to adults. BioNTech and Pfizer say that the data from the trial, which enrolled over 10,000 children, indicates the three doses in young children elicited a strong immune response and has a favorable safety profile. Adverse reactions were generally less frequent in this age group compared to children aged between 5 and 12. As such, the companies want the EU to expand its conditional marketing authorization to include the youngest children.
11th Jul 2022 - POLITICO

Scared of needles? Inhalable COVID-19 vaccine shows promise in new study

An inhalable COVID-19 vaccine has shown great promise in protecting the lungs against the coronavirus in a new study. Researchers from the US’ North Carolina State University created the inhalable vaccine that is shelf-stable at room temperature for up to three months and specifically works to target the lungs and can be self-administrated through an inhaler.
11th Jul 2022 - Al Arabiya English

4th COVID-19 vaccine effectively protects elderly against Omicron -study

The fourth dose of the coronavirus vaccine is effective in protecting the elderly against the Omicron variant and lowers their risk of death by 72% compared to those who received only three doses, according to a new study conducted by Tel Aviv University and Ben-Gurion University of the Negev in collaboration with the Health Ministry. The study, published in the peer-reviewed JAMA Internal Medicine journal, found that elderly recipients of the fourth dose were 34% more protected against infection than those who received only the third dose at four months previously. Recipients of the fourth dose were also 64-67% less likely to be hospitalized for mild to moderate and severe illness.
11th Jul 2022 - The Jerusalem Post

Moderna's Noubar Afeyan on the race to create a Covid vaccine

Moderna's Noubar Afeyan on the race to create a Covid vaccine with the Financial Times health team
11th Jul 2022 - Financial Times

Could a universal coronavirus vaccine be the silver bullet that ends this pandemic—and the next?

First-generation vaccines were not the panacea hoped for in COVID-19’s early days. Nor did herd immunity swoop in and save the day. Could a so-called “pan-coronavirus” vaccine be the long-awaited silver bullet that ends the COVID pandemic—and the next one, too? Answer: It’s complicated. “The term pan-coronavirus vaccine needs an asterisk next to it,” Dr. Stuart Ray, vice chair of medicine for data integrity and analytics at Johns Hopkins’ Department of Medicine, told Fortune.
11th Jul 2022 - Fortune

CEPI provides $30m to advance novel coronavirus vaccine

The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with a consortium of research and technological institutions to fund the development of a novel vaccine to provide protection against COVID-19, as well other SARS-like Betacoronaviruses.
11th Jul 2022 - European Pharmaceutical Review

Hologic Announces Two New Respiratory Assays for the Detection of COVID-19, Flu A, Flu B and RSV

Hologic, Inc. announced that it is now offering its Panther Fusion ® SARS-CoV-2/Flu A/B/RSV assay and its Novodiag ® RESP-4 molecular diagnostic test for sale in the European Union in time for the northern hemisphere’s respiratory viral season. Both assays detect and differentiate four of the most prevalent respiratory viruses that can present with similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), influenza B (Flu B) and respiratory syncytial virus (RSV). The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a high-performance cartridge-based assay that runs on the fully automated high-throughput Panther Fusion system. The test uses nasopharyngeal swab samples.
11th Jul 2022 - The Associated Press

Study reveals sex-based differences in the clinical outcomes of COVID-19 in the US

In a recent study posted to the Research Square* preprint server, researchers investigated sex-based differences among coronavirus disease 2019 (COVID-19) patients in the United States (US). Studies have reported greater severity and fatality associated with COVID-19 among men compared to women across the globe; however, the mechanisms for sex-based differences in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are not clear. Previous research observations indicate that researchers must consider the patients’ sex as an important variable for COVID-19 data interpretation.
11th Jul 2022 - News-Medical.Net

BioNTech, Pfizer ask EU to authorize 3-dose COVID-19 vaccine for kids over 6 months

ECDC and EMA update recommendations on additional booster doses of COVID-19 vaccines

The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) are recommending that second booster doses of COVID-19 vaccines be considered for people between 60 and 79 years old and people with medical conditions putting them at high risk of severe disease.
11th Jul 2022 - ECDC.Europa.eu

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Jul 2022

View this newsletter in full

Pfizer, BioNTech Get Full FDA Approval for Covid Vaccine for Teens

Pfizer Inc. and BioNTech SE gained full US regulatory approval for their Covid-19 vaccine for teens 12 to 15 years old, a milestone that will allow the companies to continue to market it to adolescents after the pandemic. The vaccine partners earlier got formal approval for their Covid vaccine for teens 16 and older. In a statement on Friday, the companies said the US Food and Drug Administration approved their supplemental application to extend that approval to younger adolescents. The shot first went into play when it received emergency use authorization, a temporary clearance for use during the pandemic, for the age group. For full approval, the companies submitted additional information to the FDA, including six months of follow-up data after the two-dose regimen was complete in recipients.
10th Jul 2022 - Bloomberg

South Africa’s Afrigen to collaborate with US researchers on mRNA vaccines

South African biotech company Afrigen will collaborate with researchers from the US National Institutes of Health on the development of the next generation of mRNA vaccines and drugs as part of an attempt to expand global access to innovative medicines.
8th Jul 2022 - The Financial Times

Covid-19: FDA authorises pharmacists to prescribe Paxlovid

The US Food and Drug Administration (FDA) has authorised licensed pharmacists to prescribe Pfizer’s oral antiviral drug Paxlovid (nirmatrelvir and ritonavir) to eligible patients who have tested positive for covid-19, subject to some limitations. The FDA’s action on 6 July, a revision of the emergency use authorisation, will make the drug more widely available to people with covid-19, particularly in rural and poor areas. About 90% of the US population lives within five miles of a pharmacy, according to the American Pharmacists Association. Until now, only doctors, nurses, and physician assistants could prescribe Paxlovid. The drug is approved for treatment of mild to moderate covid-19 in adults and children aged 12 or older who weigh at least 40 kg and are at high risk for progression to severe covid-19, including hospital admission or death. Those who report a positive home test on either a rapid antigen diagnostic test or a polymerase chain reaction test are eligible for Paxlovid without further testing.
8th Jul 2022 - The BMJ

South Africa's Afrigen partners with U.S. on mRNA vaccine research

South Africa's Afrigen Biologics Limited said on Friday that it will collaborate with U.S. government researchers to develop mRNA vaccines and therapeutics. The agreement will enable the sharing of scientific expertise, technical skills and materials with the U.S. National Institutes of Health (NIH) to help Afrigen produce mRNA vaccines against COVID-19 and other diseases, said the Cape Town-based biotech start-up.
8th Jul 2022 - Reuters

EU drugs regulator open to COVID boosters that target older Omicron offshoots

The European Medicines Agency (EMA) is open to using next generation COVID-19 vaccines that target older offshoots of the Omicron variant this fall, an official said on Thursday, amid a rise in cases due to new Omicron subvariants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, vaccine effectiveness has taken a hit as the virus has evolved. The EMA expects new COVID vaccine boosters to be approved by September.
8th Jul 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Jul 2022

View this newsletter in full

'All-in-one' coronavirus vaccine gets backing from CEPI

A new type of vaccine - which could provide broad protection against a variety of SARS-like betacoronaviruses, including SARS-CoV-2 variants - has received backing of up to $30m from CEPI.
7th Jul 2022 - BioPharma-Reporter.com

COVID-19 vaccination with bacterial peptide conjugated to receptor-binding domain elicits potent immune response

In a recent study published in the iScience journal, researchers assessed the efficiency of immunization with a bacterial peptide conjugated to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain against SARS-CoV-2 infection. Overall, the study findings showed that the CPD-RBD vaccination elicited a potent immune response and also protected against the severe symptoms associated with COVID-19.
7th Jul 2022 - News-Medical.Net

Brii Bio introduces Covid-19 combination therapy in China

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The company developed these antibodies in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.
7th Jul 2022 - Pharmaceutical Technology

Exothera to support process development of Turkish company's COVID-19 vaccine

Turkey based Vaccizone has chosen Belgian CDMO, Exothera, to fast-track process development of its COVID-19 vaccine for European clinical trials.
7th Jul 2022 - BioPharma-Reporter.com

COVID-19 and brain damage explained

The authors suggested that antibody-triggered cytotoxicity targeting the endothelial cells probably led to neuroinflammation, vascular leakage, platelet aggregation, and neuronal damage. Overall, the study findings illustrated that immune complexes accompanying complement activation damaging the microvasculature were the primary cause of blood-brain barrier collapse, microthromboses, perivascular inflammation, and neuronal damage in SARS-CoV-2 patients. The authors proposed that these events largely influenced the neurological symptoms found in acute COVID-19 and probably in long-COVID. Importantly, the current findings indicated the need for therapeutic modalities targeting the development of the immune complex.
7th Jul 2022 - News-Medical.Net

Africa CDC says it has signed MOU with Pfizer for COVID pill

Africa's top public health body said on Thursday it had signed a memorandum of understanding with Pfizer for countries on the continent to receive supplies of the Paxlovid pill to treat COVID-19. Data from a mid-to-late stage study in November last year showed the antiviral medication was nearly 90% effective in preventing hospitalisations and deaths compared to a placebo, in adults at high risk of severe illness.
7th Jul 2022 - Reuters

Wastewater study technique finds virus variants sooner; many patients are using meds affected by Paxlovid

With just a very small amount of raw sewage and a new analysis technique, researchers can determine the genetic mixture of SARS-CoV-2 variants in the community and detect new variants up to 14 days before they start showing up on patients' nasal swabs, according to a new report. Tests of a new method for wastewater genomic surveillance at the University of California, San Diego campus from November 2020 to September 2021 detected the Epsilon, Alpha and Delta variants "earlier and more consistently than clinical samples, and identified multiple instances of virus spread" that were not detected with traditional monitoring, researchers reported on Thursday in Nature.
7th Jul 2022 - Reuters

New Covid variants threaten China’s mRNA vaccine hopes

China is making progress in efforts to develop a homegrown messenger RNA Covid-19 vaccine, but experts warn that it risks being outpaced by rapid mutations of the Omicron coronavirus variant. Beijing’s refusal to approve foreign jabs, and the limited effectiveness of the more traditional inactivated vaccines available from domestic companies, mean an mRNA vaccine is widely seen as essential to any shift away from President Xi Jinping’s economically costly zero-Covid policy.
7th Jul 2022 - Financial Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Jul 2022

View this newsletter in full

Study: COVID would have killed 58% more Americans without vaccines

A new study estimates that COVID-19 vaccinations averted 58% of U.S. deaths that could have occurred in a hypothetical scenario in which no inoculations existed. Published Wednesday in JAMA Network Open, the modeling study concludes that COVID-19 vaccinations prevented 27 million infections, 1.6 million hospitalizations and 235,000 deaths among U.S. adults from December 2020 to September 2021. However, the study cautions that it relied on “incomplete national data” from multiple health records due to the lack of a national database and the “limitations of current methods” for measuring vaccine effectiveness.
6th Jul 2022 - Washington Times

EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in June this year.
6th Jul 2022 - Pharmaceutical Technology

COVID in California: Reinfection heightens risk of other health problems, study finds

A new type of vaccine protects against a variety of betacoronaviruses including the one that caused the COVID-19 pandemic and COVID’s variants, in mice and monkeys, a Caltech study found. Betacoronaviruses are a subset of coronaviruses that infect humans and animals. The study, published in the journal Science on Tuesday, from researchers in the laboratory of Caltech’s Pamela Bjorkman, professor of biology and bioengineering, found that the new vaccine is broadly protective. It works by presenting the immune system with spike protein pieces from SARS-CoV-2 and seven other SARS-like betacoronaviruses, attached to a protein nanoparticle structure, to induce production of cross-reactive antibodies, Caltech said.
6th Jul 2022 - San Francisco Chronicle

COVID-19 vaccination activates antibodies targeting parts of virus spike protein shared between coronaviruses

"Our theory is that there is actually memory from previous common cold coronavirus encounters, and when you get the vaccine for SARS-CoV-2, the vaccine reawakens some of those memories. Then you see this early response which is basically just a rapid memory response to what you've already seen," Altin said. "With time, the immune system can reshape those responses more in the direction of the pandemic virus."
6th Jul 2022 - Medical Xpress

Research highlights importance of designing effective COVID vaccine allocation strategies

In a recent study posted to the medRxiv* pre-print server, researchers at the University of Melbourne used a modified Susceptible, Exposed, Infectious, and Recovered (SEIR) mathematical model to examine the impact of different vaccine mechanisms and disease characteristics on a population comprised of individuals at high and low risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The study highlighted the significance of devising effective coronavirus disease 2019 (COVID-19) vaccine allocation strategies before the onset of the pandemic or the beginning of viral transmission at the community level.
6th Jul 2022 - News-Medical.Net

Two or 3 vaccine doses may cut risk of long COVID

An observational study of Italian healthcare workers infected with SARS-CoV-2 who didn't require hospitalization suggests a link between two or three doses of vaccine and a lower prevalence of long COVID. In the modeling study, published late last week in JAMA, researchers in Milan studied 2,560 workers at nine healthcare facilities from March 2020 to April 2022. All healthcare workers were mandated to receive three doses of the Pfizer/BioNTech mRNA COVID-19 vaccine in 2021. And all were screened for COVID-19 once a week or every 2 weeks and when they developed symptoms or were exposed to the virus.
6th Jul 2022 - CIDRAP

Estimates of long Covid are startlingly high. Here’s how to understand them

It’s important to remember that long Covid is an evolving umbrella term for an array of symptoms that vary in both number and degree. Some housebound people are assailed by brain fog that completely robs them of concentration, while others find memory aids help them get through their workdays. Some former athletes can’t complete a 6-minute walk test, while others can gradually return to activity if they monitor their heart rate. Long Covid clinics that adapt techniques from rehabilitation medicine see people eventually get better. In a world transitioning away from bustling downtowns to hybrid work-from-home status, we may not see who’s missing.
6th Jul 2022 - STAT News

Pharmacists Can Prescribe Pfizer's Covid Pill Under FDA Order

Pharmacists will be permitted to prescribe Pfizer Inc.’s Paxlovid under a move by US regulators aimed at providing prompt access to the widely used Covid treatment. State-licensed pharmacists can prescribe Paxlovid to eligible patients, subject to certain limitations to assure appropriate treatment, the Food and Drug Administration said Wednesday in a statement. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients,” Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, said in the statement.
6th Jul 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Jul 2022

View this newsletter in full

The Health Risks of Getting Covid-19 a Second (or Third) Time

Covid-19 reinfections can bring some new risks of serious medical problems, hospitalization and death, a new study has found. Protection provided by vaccines and prior infection has greatly improved Covid outcomes since the pandemic’s early days, and reinfections are typically less severe than initial ones. Yet each new infection carries a risk of medical problems, including hospitalization, death and long Covid, according to preliminary data from a study of patients in the Veterans Affairs health system. This is a timely finding, doctors say, as more-infectious Omicron subvariants BA.4 and BA.5 proliferate and are expected to make reinfections more common.
5th Jul 2022 - The Wall Street Journal

Health Ministry approves COVID-19 vaccine for infants

Health Ministry Director General Professor Nachman Ash has approved the administration of Moderna's Pfizer-BioNTech's COVID-19 vaccines for infants and children ages six months to five years. Though the approval applies to all children in the above age group, the Health Ministry has not issued a general recommendation for the vaccine. The vaccines were approved last month by the US Food and Drug Administration (FDA), and later the same month by the Israeli Health Ministry's Staff for the Management of Pandemics.
5th Jul 2022 - Arutz Sheva

Oxford University Takes Aim at Future Pandemics After Covid Vaccine

The University of Oxford, one of the first to cross the finish line with a Covid-19 vaccine, is shifting its focus to health threats that could trigger the next pandemic. Oxford’s Pandemic Sciences Institute, launched Tuesday, aims to reduce the risks posed by infectious diseases by improving data collection, strengthening surveillance and helping to create vaccines and other countermeasures. Oxford said the organization will seek to learn from the response to Covid and take advantage of the university’s research and global partnerships. But it will have to bring in additional funds to carry out its mission.
5th Jul 2022 - Bloomberg

Spectacular success of mRNA COVID-19 vaccines just a glimpse of their full potential

The "spectacular" success of mRNA (messenger ribonucleic acid) vaccine technology against SARS-CoV-2 provides "just a glimpse of their full potential", according to the authors of a Perspective published by the Medical Journal of Australia today. Asymptomatic individuals constitute 16–38% of the SARS-CoV-2 infected population which increases the difficulty of identifying infected individuals. The lack of convenient and sensitive tests to detect the virus in all individuals is continuing to limit global response to the pandemic. Predominantly, SARS-CoV-2 is detected through RT-PCR (real-time reverse transcription polymerase chain reaction) on swab samples collected from the nose and throat. However, these tests require long detection times, high costs, specialized equipment and medical personnel, and are not feasible in areas where resources are limited.
5th Jul 2022 - Medical Xpress

Skin Patch Test Detects COVID-19 in Under Three Minutes

A rapid and reliable skin-patch test can now detect the COVID-19 virus, and potentially other infectious agents in under three minutes, without the need to draw blood. This convenience overcomes a current challenge in identifying infected individuals who are averse to blood tests and could help restrict the spread of the pandemic. The details of the new test were published on July 1, 2022, in an article in the journal Scientific Reports titled, “Anti‑SARS‑CoV‑2 IgM/IgG antibodies detection using a patch sensor containing porous microneedles and a paper‑based immunoassay.”
5th Jul 2022 - Genetic Engineering & Biotechnology News

The Health Risks of Getting Covid-19 a Second (or Third) Time

CureVac files patent lawsuit in Germany against BioNTech

CureVac has filed a patent lawsuit in Germany against BioNTech over its use of mRNA technology, marking one of the first known cases of a company going to court amid the fierce competition to develop a vaccine against the coronavirus. The German-based biotech company is seeking "fair compensation" from BioNTech and two subsidiaries for infringement of its intellectual property rights, it said on Tuesday.
5th Jul 2022 - Reuters

New Covid subvariants BA.4 and BA.5 are the most contagious yet – and driving Australia’s third Omicron wave

Australia is heading for its third Omicron wave in the coming weeks, as BA.4 and BA.5 become the dominant Covid strains. BA.4 and BA.5 are more infectious than previous Covid variants and subvariants, and are better able to evade immunity from vaccines and previous infections. So we’re likely to see a rise in case numbers. So what are BA.4 and BA.5? And what can we expect in this next phase of the pandemic?
5th Jul 2022 - The Guardian

BA.5 Subvariant Drives Majority of Recent Covid-19 Cases

The highly contagious Omicron BA.5 subvariant has taken over as the dominant version of the virus causing new Covid-19 cases in the U.S., the latest federal data show. BA.5 represented nearly 54% of U.S. cases in the week ended July 2, the Centers for Disease Control and Prevention estimated Tuesday. It surpassed BA.2.12.1, the version of Omicron partly responsible for a persistent springtime surge in cases, which is now estimated to represent closer to one in four cases. Another version known as BA.4, which is closely related to BA.5, and also ramped up recently, represents nearly 17% of cases, the CDC estimates.
5th Jul 2022 - The Wall Street Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Jul 2022

View this newsletter in full

Long COVID: 'Viral reservoir' of spike protein may explain long-term symptoms

Researchers investigated the antigens of SARS-CoV-2—the virus that causes COVID-19—present in blood plasma samples collected from individuals with long COVID and typical COVID-19 infection. They found that one particular SARS-CoV-2 antigen—the spike protein—was present in the blood of a majority of long COVID patients, up to a year after they were first diagnosed with COVID-19. In patients with typical COVID-19 infection, however, the spike protein was not detected. This finding provides evidence for the hypothesis that SARS-CoV-2 can persist in the body through viral reservoirs, where it continues to release spike protein and trigger inflammation.
4th Jul 2022 - Medical News Today

Hong Kong's Lee Sees No Immediate Need for Mass Covid Testing

Hong Kong’s new Chief Executive John Lee said there is no immediate need for a universal compulsory Covid testing campaign in the city but stressed that there needs to be a reduction in the number of daily infections, which are at the highest level since April. Lee, appearing on a program broadcast by TVB on Sunday, shed more light on his Covid agenda for the first time since being sworn in as chief executive on Friday by Chinese President Xi Jinping, who was also in the city to celebrate the 25th anniversary of its return to Chinese rule. Hong Kong should carry out more laboratory nucleic acid testing for Covid because it’s a reliable way to detect infections, but this would not expand into a universal compulsory testing campaign for now,
4th Jul 2022 - Bloomberg

Covid Shots Are Coming. Will They Be Too Late?

Roseann Renouf, 77, has grown tired of the current generation of coronavirus shots. Having “never been one for a lot of vaccination,” she decided to forgo the latest round of boosters after watching vaccinated friends contract Covid-19, even though the doses offer a critical extra layer of protection. “It’s just taking another same booster,” Ms. Renouf, a retired nurse anesthetist from Fort Worth, said. “They haven’t done anything different with them to cover new variants.” But her gripe about the Covid vaccines may soon be settled. American regulators committed last week to updating the 2020 vaccine recipes for this fall’s booster campaign with new formulas meant to defend against the ultra-contagious Omicron subvariants, offering Ms. Renouf and other holdouts a fresh reason to change their minds.
4th Jul 2022 - The New York Times

Oxford Biomedica, AstraZeneca enter new deal for Covid-19 vaccine

Oxford Biomedica has entered a new three-year Master Services & Development Agreement to potentially manufacture AstraZeneca UK’s Covid-19 vaccines in the future. The latest deal is an extension of an original Master Supply and Development Agreement signed by the parties in September 2020. Under the initial deal, the production of Covid-19 vaccines at the Oxbox facility of Oxford Biomedica is anticipated to conclude in the last quarter of this year. As per this agreement, AstraZeneca had agreed to make an upfront payment of $18.1m (£15m) to Oxford Biomedica as a capacity reservation fee.
4th Jul 2022 - Pharmaceutical Technology

Paxlovid remains effective in those vaccinated against COVID-19

Israeli researchers have found that paxlovid use in those at risk of COVID-19 progression remains effective even in fully vaccinated patients. The effectiveness of the anti-viral drug paxlovid in preventing the progression of COVID-19 remains even in those who have been adequately vaccinated against the virus according to the results of a real-world study by Israeli researchers. Paxlovid consists of nirmatrelivir, a protease inhibitor against COVID-19 and ritonavir, which reduces the in vivo metabolism of nirmatrelivir. The published data for the drug (the EPIC-HR trial) suggested that treatment of symptomatic COVID-19 in patients at risk of progression to severe disease, results in an 89% lower risk compared to placebo. Nevertheless, the study was undertaken before omicron became the main circulating variant and therefore the generalisability of the study’s findings are potentially limited.
4th Jul 2022 - Hospital Healthcare Europe

Omicron-specific COVID shots could increase protection as boosters, European Medicines Agency says

Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday. Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
4th Jul 2022 - Reuters

'Two doses are no longer enough': Canadians required to get COVID shot every nine months

Canadians will be required to get a booster shot every nine months for the foreseeable future, Health Minister Jean-Yves Duclos told reporters. So if you thought you were fully vaccinated, think again. Duclos said that the previous definitions of “fully vaccinated” makes no sense, explaining that it’s more important that shots are “up to date” and whether or not a person has “received a vaccination in the last nine months.” He added, “We will never be fully vaccinated against COVID-19,” according to Blacklock’s Reporter. Duclos was asked if he was preparing Canadians for the return of vaccine mandates in the fall, he reportedly replied, “We must continue to fight against COVID.”
4th Jul 2022 - Toronto Sun

COVID vaccines prevented poor outcomes in people of all sizes

COVID-19 vaccination protected people of all body sizes from hospitalization and death—although vaccinated people with a low or high body mass index (BMI) were at greater risk, according to a study of adults in England published yesterday in The Lancet Diabetes & Endocrinology. University of Oxford researchers led the study, which involved 9,171,524 adult primary care patients in England with available body mass index (BMI) data from Dec 8, 2020 (when the COVID-19 vaccine first became available in the United Kingdom), to Nov 17, 2021. Average patient age was 52 years, and average BMI was 26.7 kilograms per meter squared (kg/m2) (overweight).
1st Jul 2022 - CIDRAP

Oxford Biomedica signs up for 3 more years of making AstraZeneca COVID shots⁠—on an 'as needed basis'

There was a time—not so long ago—when COVID-19 vaccine manufacturers couldn’t produce doses fast enough. But that was then, and this is now: Friday, when Oxford Biomedica revealed an extension of its contract with AstraZeneca through 2025, the deal was to make shots on an “as needed basis,” the company said. This comes just nine months after Oxford announced a 50 million pound sterling ($68 million) investment from the over-strapped Serum Institute of India to increase its ability to manufacture COVID vaccines for AZ at its Oxbox facility.
1st Jul 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Jul 2022

View this newsletter in full

Study determines ideal COVID19 vaccine type, timing during pregnancy

Since the COVID-19 vaccine rollout, data has indicated that inoculation during pregnancy can help to protect both the mother and baby. New research collaboratively conducted at Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH), published in the peer-reviewed Nature Communications, looked further into the extent of this protection by examining which vaccine is most effective, and when.
1st Jul 2022 - The Jerusalem Post

COVID-19 vaccination for children aged 5–11 years

When considering risks, post-implementation studies have found BNT162b2 to be safe in children aged 5–11 years.17 Importantly, the small but serious risk of vaccine-induced myocarditis appears to be much lower in children aged 5–11 years (reporting rate of 2·2 cases per million doses) than in adolescents or young adults.17 Implementation of a large-scale immunisation programme, however, comes with both financial and opportunity costs—for example, diversion of health-care staff and resources could potentially affect the provision of other crucial health-care services, such as routine childhood immunisation programmes. Clinicians and parents must balance the relatively small risks of severe disease outcomes with the relatively small risks that accompany vaccination in children aged 5–11 years. Although many countries continue to actively recommend COVID-19 vaccination for children aged 5–11 years, some countries, such as Sweden, have advised against vaccinating healthy 5–11 year-olds,18 whereas others, such as Norway, have made the vaccine available should parents wish to vaccinate their children.19 With the US Food and Drug Administration authorisation of use of COVID-19 vaccines in children younger than 5 years,20 the same dilemmas are likely to resurface, although with even more marginal risk–benefit ratios. In particular, considering that the global population has been living through the pandemic for more than 2 years and has been exposed to multiple waves of different SARS-CoV-2 variants, governments, policy makers, and clinicians need to urgently address the added value of vaccination—be it primary or boosters—for protection against severe disease outcomes in children who have already been infected by the virus. Above all, public messaging of the risks and benefits of vaccinating children against COVID-19 needs to be clear to encourage public confidence in vaccines and trust in those advocating for vaccination to prevent other, more serious diseases.
1st Jul 2022 - The Lancet

Pfizer seeks approval from US FDA for Covid-19 treatment

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally. Due to the oral form, the therapy can be prescribed in the early infection stage to avert severe illness. Paxlovid received emergency use authorization to treat mild-to-moderate Covid-19 in adults and paediatric patients aged 12 years and above who are at increased disease progression risk.
1st Jul 2022 - Pharmaceutical Technology

Two-week break from methotrexate may boost Covid-19 vaccine effect

A two-week break from taking methotrexate after a Covid-19 booster vaccine can help improve its effectiveness, a UK trial has suggested. Analysis of immune responses in 127 participants who were randomly allocated to suspend methotrexate use for two weeks and 127 to continue using it as usual, showed such a difference that researchers stopped the trial early. At four weeks and 12 weeks after the Covid-19 jab, participants’ spike-antibody levels were more than two-fold higher in the paused methotrexate group compared with those who continued to take the drug. Reporting in The Lancet Respiratory Medicine, the researcher also found a worsening of disease control at week four in those who had stopped taking methotrexate but that it had normalised by week 12. Overall, there was no impact on quality of life or general health, suggesting the approach could be useful for more than a million people in the UK who take the immune-suppressing drug for inflammatory conditions.
1st Jul 2022 - Pulse Today

Modified mRNA COVID shots could increase protection as boosters - EMA

Oxford Biomedica signs new deal to make AstraZeneca COVID shot

Britain's Oxford Biomedica said on Friday it had signed a new three-year agreement to potentially make AstraZeneca's COVID-19 vaccine beyond 2022, but no volumes were defined in an indication of waning demand for the shot. Cell and gene therapy firm Oxford Biomedica said in April that it had manufactured more than 100 million doses of AstraZeneca's vaccine since their partnership began in September 2020. Commitments under the deal are scheduled to end this year.
1st Jul 2022 - Reuters

US FDA wants COVID boosters targeting Omicron BA.4, BA.5 subvariants

The U.S. Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants of the coronavirus. If authorized, the changes would mark the first major retooling of COVID vaccines, but also could slow their rollout as the FDA has recommended a design somewhat different from what the companies had already tested and started producing.
1st Jul 2022 - Reuters

Omicron-specific COVID shots could increase protection as boosters - EMA

Oxford Biomedica (LON:OXB) Signs Covid Vaccine Deal With AstraZeneca

Oxford Biomedica Plc has signed a three-year agreement with AstraZeneca Plc to manufacture the UK drug giant’s Covid-19 vaccine on an as-needed basis. The agreement is an extension of the original supply and development agreement signed between the two companies in September 2020, as the coronavirus swept around the world, according to a statement Friday. Oxford Biomedica stock was up more than 3% in early trading in London.
1st Jul 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Jul 2022

View this newsletter in full

Fair Pharma Scorecard shows industry has a long way to go for COVID-19 products

How has the pharma industry weighed human rights during its marketing of COVID-19 drugs and vaccines? That’s what the Pharmaceutical Accountability Foundation (PAF) sought to answer, and the results might not be what the industry wants to hear. For its Fair Pharma Scorecard project, PAF ranked 26 companies involved in selling COVID-19 drugs, vaccine and diagnostics based on their compliance with 19 human rights principles. Not one company complied with all the criteria, and most "still need to take big steps" to make their products accessible and affordable, PAF said. In general, PAF noticed a weariness toward knowledge sharing, iffy transparency levels and differences between various products at the same companies. For example, Pfizer's compliance with the criteria scored at 65% for its oral antiviral Paxlovid and 50% for its vaccine.
30th Jun 2022 - FiercePharma

Fauci says he believes Paxlovid kept him out of the hospital, even though he tested positive again.

“Paxlovid did what it was supposed to do,” Dr. Fauci, 81, said in an interview, saying that he believed that the treatment, made by Pfizer, kept him out of the hospital when he first tested positive for the virus on June 15. He added that he thought the drug also reduced the severity of his initial symptoms. One thing Paxlovid could not do was keep Dr. Fauci from missing his daughter’s wedding. It went on without him in New Orleans two Saturdays ago, when he was sidelined with his initial infection. He participated remotely. Dr. Fauci has been vaccinated against Covid and has received two booster doses. His experience with Paxlovid adds to a growing body of anecdotal evidence about patients whose Covid symptoms improved after they took Paxlovid, and who even tested negative, only to have symptoms occur again a few days later. That is exactly what happened to him, Dr. Fauci said; he recently tested positive again after three days of negative tests.
30th Jun 2022 - The New York Times

Pfizer Seeks FDA’s Full Approval for Paxlovid Covid-19 Pill

Pfizer Inc. has asked the Food and Drug Administration to grant full approval of its Covid-19 antiviral pill, a step toward allowing the drugmaker to sell the drug commercially. Pfizer said Thursday that it had filed the submission. The FDA typically has 60 days to accept the application and up to 10 months to conduct a review before issuing a decision. To date, Pfizer has been selling the drug, called Paxlovid, to the federal government under an authorization for emergency use. The federal government has then been directing the pills’ distribution.
30th Jun 2022 - The Wall Street Journal

A 14-year-old tiger died after contracting Covid-19 in an Ohio zoo, officials say

A tiger at an Ohio zoo died of health complications caused by Covid-19, officials said Wednesday. The 14-year-old Amur tiger, Jupiter, died Sunday after developing pneumonia caused by the virus, the Columbus Zoo and Aquarium said in a statement. Jupiter was undergoing long-term treatment for chronic underlying illnesses, which made him more susceptible to the virus, the zoo said. Jupiter's care team reported last week that he had been "acting ill." He wasn't interested in eating or interacting with his keepers and was reluctant to move or stand, according to the statement. After Jupiter was anesthetized for examination, results suggested he may have been suffering from an infection, and treatment began.
30th Jun 2022 - CNN

Covid-19: Canada outperformed comparable nations in pandemic response, study reports

Canada performed better than the majority of G10 countries in its response to the first two years of the covid-19 pandemic, a study has concluded. A paper published in the Canadian Medical Association Journal concluded that Canadians were better vaccinated than comparable western countries, with fewer infections, fewer covid deaths, and lower mortality from all causes. Researchers from the University of Toronto, some of whom are members of Ontario’s covid-19 science advisory board, linked the country’s lower death rate to the persistence of its social restrictions and the relative lack of antivaccine sentiment. The study compared responses from the 11 countries in the G10, comprising Canada, Belgium, France, Germany, Italy, Japan, the Netherlands, Sweden, Switzerland, the UK, and the US. Japan was an extreme outlier, with by far the fewest deaths and infections despite having the oldest population and imposing the mildest restrictions.
30th Jun 2022 - The BMJ

S.Korea authorises AstraZeneca COVID therapy Evusheld for vulnerable people

South Korea on Thursday authorised AstraZeneca PLC's antibody-based therapy for preventing COVID-19 infection in people with a poor immune response, increasing its options as it works to ease the pandemic burden on the healthcare system. The Ministry of Food and Drug Safety granted emergency use authorisation for 20,000 doses of Evusheld for individuals aged 12 years and older who have not been exposed to the coronavirus.
30th Jun 2022 - Reuters

Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid

Pfizer Inc said on Thursday it is seeking full U.S. approval for its oral COVID-19 antiviral treatment Paxlovid, which is currently available under an emergency use authorization (EUA). Pfizer said it submitted a New Drug Application for Paxlovid to the Food and Drug Administration for the treatment of COVID-19 in vaccinated and unvaccinated people at high risk of progression to severe illness.
30th Jun 2022 - Reuters

NYC to Offer Pfizer's Covid Drug at Mobile Test-to-Treat Sites

New York City will start offering Pfizer Inc.’s Covid antiviral Paxlovid at “first of its kind” mobile test-to-treat sites across the city, providing immediate treatment for those who test positive for the virus. Initially, mobile sites will be stationed outside of pharmacies in Inwood, South Ozone Park and the East Bronx, and will expand to 30 locations by the end of July, Manhattan’s Borough President Mark Levine said on Twitter Thursday. People who test positive for Covid and qualify for Paxlovid will be able to get a prescription on-the-spot, which they can take to a nearby pharmacy to pick up the drug. By the end of the summer, officials plan to bypass pharmacies entirely, offering Paxlovid directly through the mobile sites.
30th Jun 2022 - Bloomberg

Maternal deaths climbed 33% during COVID-19

Maternal deaths in the first months of the COVID-19 pandemic increased 33%—and even higher in Black and Hispanic women—according to data from the National Center for Health Statistics (NCHS) published yesterday in a study in JAMA Network Open. That rate compares with an overall 22% COVID-related excess death rate during the study period, according to two researchers from the University of Maryland (UMD) and Boston University (BU), who conducted the study. They defined maternal mortality as deaths during pregnancy or just after birth.
29th Jun 2022 - CIDRAP

COVID-19 tracker: Pfizer seeks full approval for Paxlovid

After running six months on an emergency use authorization for Paxlovid, Pfizer is now seeking a full FDA approval for the COVID antiviral in patients who are at high risk for progression to severe illness regardless of their vaccination status. When taken within five days of symptom onset, Paxlovid cut the risk of hospitalization or death from any cause by 86% in non-hospitalized, high-risk patients, according to final results from the phase 2/3 EPIC-HR study. Pfizer's application package also includes data from the EPIC-SR study, which didn't hit its goal in vaccinated patients with, and unvaccinated patients without, risk factors for severe COVID.
29th Jun 2022 - FiercePharma

FDA: Don’t rush a move to change the Covid-19 vaccine composition

On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2 to approve the use later this year of Covid-19 vaccines based on an Omicron variant sequence. One of us (P.A.O.) was among those voting “no.” It is possible these vaccines will be two-component designs that also include the current version. Will Americans soon be better protected against Covid-19? The Covid-19 vaccines currently authorized for use in the U.S. are all based on the sequence of the original SARS-CoV-2 virus, which was obtained early in 2020. The virus has evolved over the past 30 months, creating variants that are either more infectious, or harder to counter by vaccination, or both
29th Jun 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Jun 2022

View this newsletter in full

Doctors treat first UK patient in Covid ‘super donor’ blood trial

Doctors have treated the first UK patient in a reopened clinical trial that will explore whether blood plasma from “super donors” can help fight Covid in those with weakened immune systems. Super donors produce exceptionally high levels of antibodies after infection and vaccination, and there are hopes that transfusions of their blood plasma can wipe out the virus in people whose own immune systems are compromised. While two landmark trials known as Recovery and Remap-Cap found that convalescent plasma from people who recovered from Covid did not benefit other patients, a closer look at the Remap-Cap data showed that plasma with the highest levels of antibodies might help the immunosuppressed. The findings prompted doctors to reopen the plasma arm of the Remap-Cap trial to investigate specifically whether donated plasma with extremely high levels of antibodies can save the lives of people with weakened immune systems and reduce the amount of time they spend in intensive care.
30th Jun 2022 - The Guardian

How the UK’s rising Covid cases compare to other countries

The UK is facing its fifth wave of Covid infections, experts have warned, as cases hit 1.8m in the latest weekly figures, a 23 per cent climb week-on-week. More worryingly, hospital admissions have increased 31 per cent, climbing at a higher rate than the last Omicron revival back in March.
30th Jun 2022 - The Independent

Coronavirus vaccines should be updated for fall, FDA advisers say

It’s time to update coronavirus vaccines to better match the variants currently driving the pandemic, outside experts told the Food and Drug Administration on Tuesday. The independent scientists and physicians endorsed an updated omicron vaccine by a 19-2 vote. Despite the overwhelming agreement that it is time to change the vaccine, many experts said they felt frustrated and hamstrung by the need to make a decision quickly to prepare for fall with limited data.
29th Jun 2022 - The Washington Post

BioNTech, Pfizer to start testing universal vaccine for coronaviruses

Germany's BioNTech, Pfizer's partner in COVID-19 vaccines, said the two companies would start tests on humans of next-generation shots that protect against a wide variety of coronaviruses in the second half of the year. Their experimental work on shots that go beyond the current approach include T-cell-enhancing shots, designed to primarily protect against severe disease if the virus becomes more dangerous, and pan-coronavirus shots that protect against the broader family of viruses and its mutations.
29th Jun 2022 - Reuters

S.Korea approves first domestically developed COVID vaccine

South Korea approved its first domestically developed COVID-19 vaccine, manufactured by SK bioscience Co Ltd, for general public use following positive clinical data, authorities said on Wednesday. The SKYCovione vaccine was authorised for a two-dose regimen on people aged 18 or older, with shots given four weeks apart, according to the Ministry of Food and Drug Safety. In a phase III clinical trial of 4,037 adults, SKYCovione induced neutralizing antibody responses against the SARS-CoV-2 parental strain, SK bioscience said in a statement.
29th Jun 2022 - Reuters

U.S. FDA advisers recommend change to COVID vaccine composition for fall

Advisers to the U.S. Food and Drug Administration on Tuesday recommended a change in the design of COVID-19 booster shots this fall in order to combat more recently circulating variants of the coronavirus. The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-2 that the next wave of COVID booster shots should include a component that targets the Omicron variant of the coronavirus.
29th Jun 2022 - Reuters

Covid: Face masks brought back at Nottinghamshire hospital sites

Face masks have been reintroduced at some Nottinghamshire hospitals just two weeks after they were dropped. Mask policy had been relaxed in all but high-risk areas of Sherwood Forest Hospitals' three sites as part of a phased return to pre-pandemic policies. But a rise in covid cases among staff and patients at King's Mill, Newark and Mansfield Community hospitals has led to the decision being reversed. Bosses said they would keep face mask and visiting requirements under review.
29th Jun 2022 - BBC News

FDA advisers call for Omicron update for COVID boosters

The Food and Drug Administration (FDA) outside advisory committee today recommended that new booster shot versions include an Omicron variant component, as newer subvariants expand their footprint and the nation faces an uncertain fall and winter with the virus. In its weekly update today, the Centers for Disease Control and Prevention (CDC) said the proportion of BA.4 and BA.5 subvariants increased sharply last week, mainly due to BA.5.
28th Jun 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Jun 2022

View this newsletter in full

Korea's First Home-Grown COVID-19 Vaccine To Speed Hub Ambitions

Only one last step remains before the approval of South Korea’s first home-grown COVID-19 vaccine as SK Bioscience’s SKYCovione (GBP510) receives positive assessments from review committees. Any nod, which could happen this week, would mark a milestone for the country's ambitions of becoming a global vaccine hub.
28th Jun 2022 - Pink Sheet

Rare heart-related side effects higher with Moderna COVID vaccine

Though both complications were rare, data from Ontario show higher rates of myocarditis and pericarditis with the Moderna COVID-19 vaccine than with the Pfizer-BioNTech vaccine, but the rates were lower for both vaccines if the spacing between receiving two doses was extended, according to a study late last week in JAMA Network Open. Myocarditis is an inflammation of the heart muscle, and pericarditis involves swelling of the thin membrane around the heart.
28th Jun 2022 - CIDRAP

Indias first indigenous mRNA vaccine likely to be available soon

Soon India may have its first indigenous mRNA vaccine that is stable at 2-8 degrees Celsius as the expert panel advising the Central Drugs Standards Control Organisation (CDSCO) has green-signalled Gennova Biopharma's mRNA vaccine candidate for Covid19. The Subject Expert Committee (SEC) has recommended granting the Emergency Use Authorisation (EUA) to the country's first mRNA-based Covid-19 vaccine in a meeting held on Friday, according to reports. Now, the Drugs Controller General of India (DCGI) will take a final call on granting the final approval.
28th Jun 2022 - Business Standard

COVID was twice as deadly in poorer countries

Early in the COVID-19 pandemic, the risk of dying from the disease was roughly twice as high for people living in lower-income countries as for those in rich nations, a study reports. The research, published in BMJ Global Health in May1, is one of a growing number of studies to reveal COVID-19’s massive burden in lower-income countries. Data from early in the pandemic suggested that death and infection rates in poor countries were relatively low compared with those in rich ones. But recent evidence paints a very different picture, says Madhukar Pai, an infectious- disease epidemiologist at McGill University in Montreal, Canada. “This paper is one among many that illustrate that the biggest impact of this pandemic has been on low- and middle-income countries,” says Pai.
28th Jun 2022 - Nature.com

In 1st year of pandemic, COVID vaccines saved 20M lives

Based on official data on COVID-19 deaths, the authors estimated that vaccinations prevented 14.4 million deaths in 185 countries and territories during the one-year study duration. Based on excess mortality estimates, they observed that vaccinations halved the potential global death toll and averted around 19.8 million deaths in a year. The latter represents the true extent of the first year of the pandemic, showing a global reduction of 63% in total deaths due to vaccination.
28th Jun 2022 - News-Medical.Net

Fast-evolving COVID variants complicate vaccine updates

As countries brace for another Omicron wave driven by the variants BA.4 and BA.5, calls to update COVID-19 vaccines are growing louder. Existing vaccines based on the version of the virus SARS-CoV-2 that emerged in Wuhan, China, in late 2019 are a poor match to current Omicron strains. As a result, the vaccines now offer only short-lived protection from infection — although they seem to be holding up against severe disease. This week, an advisory panel to the US Food and Drug Administration (FDA) will meet to discuss whether COVID-19 vaccines should be updated — and what the upgraded vaccines should look like.
28th Jun 2022 - Nature.com

EnGeneIC’s second generation COVID-19 vaccine protects against all variants

The world’s first COVID-19 vaccine to offer immunity against all variants is one step closer. Clinical trials have shown the novel vaccine works by stimulating a completely different immune pathway from other vaccines, producing “high affinity” antibodies that neutralise all COVID-19 variants. Australian Biopharma company EnGeneIC is currently conducting trials of its groundbreaking vaccine in Sydney and Melbourne. Thirty-two healthy participants received two doses, three weeks apart. Of those, 27 have passed the 28-day safety assessment with no side effects. Critically, they all have high affinity antibodies capable of neutralising all COVID-19 mutants, including Omicron.
28th Jun 2022 - The Associated Press

How do I know if I've had COVID-19, and what else can antibody blood tests tell us about past infection?

Antibody blood tests can tell you if you've had COVID-19, but there are some caveats. COVID-19 antibodies naturally dwindle over time, so if they turn up in your blood test, their levels can't tell you exactly how long ago you were infected — just that you were infected sometime in the past few months. "We think now [the test] is a useful marker of fairly recent infection, as opposed to whether you've ever been infected," Dr Machalek says.
28th Jun 2022 - ABC News

Majority of secondary school children have Covid-19 antibodies, says new data

Nearly all secondary school-age children have Covid-19 antibodies, according to new data. Data from the School Infection Survey, which was released on Monday, revealed that numbers of primary school parents who would be "unlikely" to vaccinate their children has increased. The news comes as levels of Covid continue to rise in the UK, with new cases likely due to variants of the Omicron strain. In the last week, an estimated 1.7million people are reported to have had the virus, up 23% from 1.4 million the previous week.
28th Jun 2022 - Daily Record

COVID-19 fattens up our body's cells to help fuel its viral takeover, study suggests

Researchers tried using weight-loss drugs and other fat-targeting compounds to try to stop the virus in cell culture. The new study comes as infections rose in all four UK nations, with about 1.7 million having the virus last week.
28th Jun 2022 - Sky News

Improving COVID-19 vaccine immunogenicity by interrupting methotrexate treatment

In summary, this important study shows that a 2-week interruption of methotrexate after booster COVID-19 vaccination results in increased immunogenicity compared with no interruption among patients with several immune-mediated inflammatory diseases. Although this finding adds to the evidence base to support interruption of methotrexate after vaccination, a shared decision process is needed to weigh the possible benefit of optimising protection from COVID-19 and the possible risk of underlying disease flare.
28th Jun 2022 - The Lancet

U.S. FDA will decide on redesigned COVID vaccines by early July

U.S. regulators plan to decide by early July whether to change the design of COVID-19 vaccines this fall in order to combat more recent variants of the coronavirus, with hopes of launching a booster campaign by October, a top Food and Drug Administration official said on Tuesday. "The better the match of the vaccines to the circulating strain we believe may correspond to improve vaccine effectiveness, and potentially to a better durability of protection," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said at a meeting of outside expert advisers to the agency.
28th Jun 2022 - Reuters

Are Updated Booster Shots Coming?

Tomorrow will be a big day for the future of U.S. coronavirus vaccines: A panel of independent advisers to the F.D.A. will recommend whether to update the existing vaccines to take aim at a version of the virus in the Omicron family. The advisory panel also will probably split between those who believe a fall booster will be broadly necessary and those who would limit additional shots to high-risk individuals. The policy may depend on funding and resources. “It’s very clear we’re not going to have enough vaccines for every adult who wants one,” said Dr. Ashish Jha, the White House coordinator for the pandemic response.
27th Jun 2022 - The New York Times

AstraZeneca launches first Evusheld DTC, but without full approval it comes with a different feel

AstraZeneca launched the first ever COVID drug DTC for its prevention antibody, Evusheld, and it’s one of the most unusual and unique commercials you will see this year. The ad, which is set up more as a public health announcement (though is heavily branded), has a very different feel from most traditional pharma DTCs. There are no bright colors or emotional beats. You won’t find someone roller skating around a park, for instance, or someone running with their dog. What you get instead is just one narrator, standing in a bland, empty, white office space, laying out informatively how Evusheld works, who it’s for and, instead of waiting for the end of the ad, explaining many of the potential side effects in the middle of the video.
24th Jun 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Jun 2022

View this newsletter in full

Epstein-Barr may play a role in some long COVID; coronavirus can impair blood sugar processing by organs

Among 280 patients with SARS-CoV-2 infections, including 208 with long COVID, researchers found that at four months after diagnosis, fatigue and problems with thinking and reasoning were more common in study participants with immune cells in their blood showing signs of recent EBV reactivation. These signs of reactivation were not linked with other long COVID findings such as gastrointestinal or heart and lung problems, however. And EBV itself was not found in patients' blood, which suggests any reactivation likely is transient and happens during acute COVID-19, Dr. Timothy Henrich of the University of California, San Francisco and colleagues reported on medRxiv ahead of peer review.
28th Jun 2022 - Reuters

Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine

Pfizer and BioNTech have shared positive results from a phase 2/3 trial of two Omicron-adapted COVID-19 vaccine candidates. The data shows that a booster dose of both Omicron-adapted vaccines gave a considerably higher immune response against Omicron BA.1, compared to Pfizer/BioNTech’s current COVID-19 vaccine. The phase 2/3 trial involved 1,234 participants aged 56 and older. One month after receiving a booster dose, the Omicron-adapted monovalent candidates significantly increased protection against Omicron BA.1, showing a 13.5 and 19.6-fold increase above pre-booster dose levels. One vaccine is monovalent and the other is bivalent, made up from a combination of the Pfizer/BioNTech COVID-19 vaccine and a vaccine candidate designed to target the spike protein of the Omicron BA.1 variant.
27th Jun 2022 - PMLiVE

EMA recommends Novavax COVID vaccine for adolescents

EU Reporter publishes articles from a variety of outside sources which express a wide range of viewpoints. The positions taken in these articles are not necessarily those of EU Reporter.
27th Jun 2022 - EU Reporter

China's first mRNA vaccine is close — will that solve its COVID woes?

China is getting closer to approving its first mRNA vaccine to protect people against COVID-19. In a small clinical trial, the Chinese vaccine candidate triggered a stronger antibody response in vaccinated adults when given as a booster shot than did a jab containing inactivated SARS-CoV-2, the vaccine platform that the country has mostly relied on so far. The experimental jab, called ArCoV, is a strong candidate to become China’s first approved mRNA vaccine. But what it would mean for the government’s handling of the pandemic is hard to know, say researchers. A highly effective mRNA vaccine would reduce the chances of widespread serious infections that could overwhelm hospitals. However, it is unlikely to bring an end to the country’s strict ‘zero COVID’ strategy, which uses mass testing and lockdowns to quash all infections.
27th Jun 2022 - Nature.com

F.D.A. May Move Toward Updating Vaccines

A panel of independent experts advising the Food and Drug Administration is set to recommend on Tuesday whether to update existing Covid-19 vaccines to target a newer version of the coronavirus in a booster shot that Americans could get in the fall. The federal government is hoping to improve the vaccine to better boost people’s immunity before a likely resurgence of the virus this winter. But to move that quickly, it may need to abandon the lengthy human trials that have been used to test coronavirus vaccines over the past two years in favor of a faster process that relies more on laboratory tests and animal trials. The most recent trials with human volunteers have taken five months, even using relatively small groups. But the virus is evolving so quickly that new vaccine formulations are out of date before such trials are even finished.
27th Jun 2022 - The New York Times

Long Covid 2: supporting the mental and physical needs of patients

Long Covid is a multi-system condition affecting both the body and the mind that occurs in some people as a lingering consequence of a Covid-19 infection (Maxwell et al, 2022). As described in our first article in this series, symptoms are diverse and many post-Covid-19 sequelae present as undifferentiated symptoms not apparent on routine investigation (Maxwell et al, 2022). This can contribute to patients’ symptoms not always being taken seriously by health professionals. Lack of clarity over the mechanisms for long Covid means opinion can be polarised, with some practitioners believing all symptoms are physical and others that they are purely psychological. In truth, there is ample evidence that long Covid is a combination of physical and mental symptoms, many of which are undifferentiated and common in established physical and psychological conditions. Individual prognosis for individuals is hard to assess, with some people recovering within months but others still having problems after two years.
27th Jun 2022 - Nursing Times

BioNTtech in conflict with regulator over new COVID vaccine approval - WAS

The launch of German drugmaker BioNTech's vaccine adapted to the Omicron coronavirus variant may be delayed due to a disagreement with the regulator over the approval process, the Welt Am Sonntag (WAS) newspaper reported on Saturday. The regulator should still decide by the end of June whether or not to approve the new vaccine but BioNTech Chief Executive Ugur Sahin does not plan to submit any new clinical trials, WAS reported, citing the Financial Times.
27th Jun 2022 - Reuters

Sinovac's COVID-19 vaccine conditionally registered in South Africa

China's Sinovac Biotech said on Saturday that South Africa's health products regulator has granted conditional registration to its coronavirus vaccine CoronaVac for people aged 18 and above.
27th Jun 2022 - Reuters

China's Clover says its COVID booster shot candidate lifts antibody against Omicron

China's Clover Biopharmaceuticals said on Monday a booster shot of its COVID-19 vaccine candidate significantly increased antibody response against the Omicron coronavirus variant from levels seen after two primary shots. A third dose of its vaccine candidate SCB-2019 resulted in a 19-fold increase in neutralising antibody levels against the Omicron BA.2 subvariant from pre-booster levels, Clover said in a filing to the Hong Kong stock exchange.
27th Jun 2022 - Reuters

US grapples with whether to modify COVID vaccine for fall

U.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match recent changes of the shape-shifting coronavirus. Moderna and Pfizer have tested updated shots against the super-contagious omicron variant, and advisers to the Food and Drug Administration will debate Tuesday if it’s time to make a switch — setting the stage for similar moves by other countries. “This is science at its toughest,” FDA vaccine chief Dr. Peter Marks told The Associated Press, adding that a final decision is expected within days of the advisory panel’s recommendation.
27th Jun 2022 - The Associated Press

FDA panel to advise on whether — and how — Covid vaccines should be updated

The Food and Drug Administration faces an important decision in coming days — whether to instruct companies that make Covid-19 vaccines to update the viral strain or strains of SARS-CoV-2 those products target. It seems almost a given that the FDA will tell manufacturers that it is time to change the composition of Covid vaccines, with an eye to a rollout of updated vaccines to be administered in the autumn. But how and to what are questions that still need answering. The agency is seeking the advice of its independent panel of vaccine experts, the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, to help it decide how, in the words of senior FDA official Peter Marks, to predict the future. VRBPAC meets Tuesday to discuss the issue.
27th Jun 2022 - STAT News

Pfizer says its Omicron-containing boosters outperform current vaccine

Pfizer said Saturday that using new versions of its Covid-19 vaccine as boosters led to a superior antibody response against the Omicron variant compared to its current shot. The results in some ways mirror those released by Moderna earlier this month. Data from both companies will be evaluated on Tuesday by a panel of experts convened by the Food and Drug Administration in the hopes of deciding what strains of the SARS-Cov-2 virus should be included in booster shots for the fall. Companies will need lead time to manufacture doses of new vaccines if it is decided they are needed.
26th Jun 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Jun 2022

View this newsletter in full

Pfizer’s Omicron-Targeting Covid-19 Vaccines Generate Stronger Immune Response

Federal health authorities are trying to decide whether to stick with the current shots for a fall vaccination campaign or use a tweaked version. Studies have found that the current vaccines don’t work as well against Omicron as they did against earlier strains. “Based on these data, we believe we have two very strong Omicron-modified candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” Pfizer Chief Executive Albert Bourla said. The study didn’t measure whether and how well the shots reduced the risk of Covid-19. Pfizer and BioNTech announced the results by news release. The findings haven’t been published in a peer-reviewed medical journal. Omicron is the most recent strain of the virus to come to predominate in the U.S. and many other countries.
26th Jun 2022 - The Wall Street Journal

Australia struggles against vaccine fatigue as it battles flu outbreak

Australia is battling its first serious influenza outbreak since the start of the Covid-19 pandemic, leaving the authorities struggling to persuade a vaccine-weary public to get flu shots. Official data showed there were 65,770 flu cases in May - more than double the month's previous record set during a severe outbreak in 2019. But the numbers have been rapidly increasing. According to the federal government's influenza surveillance system, there were 147,155 cases of flu recorded from Jan 1 to June 19 this year. Of these, 55,101 or more than one third occurred from June 5. There have been 54 flu-related deaths.
26th Jun 2022 - The Straits Times

Expert on why you need your covid booster jab now to keep safe this winter

England’s leading NHS medic is urging those eligible for a spring booster but yet to come forward to take up the offer as soon as possible as a quarter of a million reminders go out before the end of the month. The largest and fastest vaccination programme in NHS history has now invited everyone eligible for a spring booster and more than four in five people have already had their jab. The NHS has invited more than five million people in total to get their spring booster in line with JCVI guidance as part of the world-leading NHS Covid-19 vaccination programme. It is urging anyone yet to come forward for a spring dose to do so as soon as practically possible. More than four million people and around 86% of those aged 75 and over have already had their spring dose. Those who are eligible include older adult care home residents, people aged 75 and over and those who are immunosuppressed.
25th Jun 2022 - Daily Post Wales

GSK announces that COVID-19 vaccine candidate is effective at preventing Omicron infection

The Europen companies GSK and Sanofi have partnered for a COVID-19 vaccine candidate that is 72% effective at preventing infection from the Omicron variant. The companies are hoping their shot can join the Pfizer, Moderna and Novavax vaccines in becoming available for the long-term fight against Covid. It comes as U.S. regulators face widespread criticism after the controversial approval of jabs for children six months to four year old. It comes as Covid case figures have stabilized at 99,984 per day in the U.S., but deaths have jumped 20% over the past week to 385 daily
25th Jun 2022 - Daily Mail

Greece Under Fire for Recommending 2nd COVID-19 Booster for 30+

Greek authorities’ decision to recommend a second COVID-19 booster shot for individuals over thirty was criticized by a leading health specialist on Friday. The current recommendation for a second booster shot for people aged 30 to 59 who do not belong to the vulnerable groups “is not accompanied by the necessary documentation,” Elias Mossialos, Professor of Health Policy at the London School of Economics and Political Science (LSE), has posted on Facebook. Greece’s National Vaccination Committee reiterated a “strong recommendation” that those aged 60 and over get a second booster shot. Appointments for that age category have been available since early April this year.
25th Jun 2022 - Greek Reporter

The next COVID booster shots will likely be updated for Omicron

COVID-19 vaccines this fall are likely to be based on the Omicron variant of the coronavirus rather than the original strain, although some experts suggest they may only offer significant benefits for older and immunocompromised people. Moderna, Pfizer and Novavax have been testing vaccines based on the first BA.1 Omicron variant that became dominant last winter, driving a massive surge in infections. On Wednesday, Moderna said its updated vaccine worked well against more recent Omicron subvariants, and that it was moving forward with plans to ask regulators for approval. Vaccines that can bridge the gap between the original version of coronavirus and the Omicron variant would likely be “far, far better” for the fall, according to Trevor Bedford, a biologist at the University of Washington who has closely tracked mutations of the SARS-coV-2 virus.
25th Jun 2022 - Edmonton Journal

Global impact of the first year of COVID-19 vaccination: a mathematical modelling study

COVID-19 vaccination has substantially altered the course of the pandemic, saving tens of millions of lives globally. However, inadequate access to vaccines in low-income countries has limited the impact in these settings, reinforcing the need for global vaccine equity and coverage.
25th Jun 2022 - The Lancet

Sanofi-GSK Covid vaccine found effective against Omicron

Sanofi and GlaxoSmithKline have reported promising results from trials of their Covid-19 vaccine, which has proved to be particularly effective against the Omicron strain of coronavirus. The vaccine targets the original and the Beta strains of coronavirus but was also tested against the more recent Omicron variant. When used as a first dose, it demonstrated a 64.7 per cent efficacy rate against symptomatic infection overall in adults, and was 72 per cent effective against infections caused by Omicron. The vaccine was safe and well-tolerated in a trial of 13,000 people
25th Jun 2022 - Financial Times

WHO says over 900 probable cases of acute hepatitis reported in children

Thirty-three countries have reported 920 probable cases of severe acute hepatitis in children so far, a jump of 270 from May, the World Health Organization (WHO) said on Friday. The WHO said that the European Region accounted for half the probable cases, including 267 from the United Kingdom, while a third of the probable cases were from the United States. Health authorities globally have been investigating the mysterious rise in severe cases of hepatitis - or liver inflammation – in young children. The outbreak was first reported in April in Britain and has since then hit dozens of other countries.
25th Jun 2022 - Reuters

How Serious is Monkeypox? WHO Says Not Global Emergency

The World Health Organization opted against calling the recent monkeypox outbreak a public health emergency of international concern. The outbreak is “clearly an evolving threat,” the WHO said in a statement Saturday, though it doesn’t constitute an international public health emergency “at this moment.” An emergency committee convened on Thursday to discuss the outbreak. “What makes the current outbreak especially concerning is the rapid, continuing spread into new countries and regions and the risk of further, sustained transmission into vulnerable populations including people that are immunocompromised, pregnant women and children,” according to the statement. “It requires our collective attention and coordinated action now to stop the further spread of monkeypox virus.
25th Jun 2022 - Bloomberg

European Commission grants marketing authorisation to Valneva's COVID-19 shot

French drugmaker Valneva's COVID-19 vaccine has received marketing authorisation from the European Commission (EC) for use as a primary vaccination in people from 18 to 50 years of age, the company said on Friday. The marketing authorisation will cover the European Union's member states as well as Iceland, Liechtenstein, and Norway. "Now that we have received this full marketing authorization, we hope that the EC and its member states will place orders that reflect this demand," Valneva CEO Thomas Lingelback said in a statement.
24th Jun 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Jun 2022

View this newsletter in full

CDC Advisers Endorse Moderna’s Covid-19 Vaccine for Kids 6 to 17 Years

Advisers to the Centers for Disease Control and Prevention backed use of Moderna Inc.’s Covid-19 vaccine in children ages 6 to 17 years. Children in the age group already have access to Covid-19 vaccines made by Pfizer Inc. and its partner BioNTech SE. The advisers recommended on Thursday that Moderna’s shot should also be made available to that age range, in a pair of 15-0 votes. The advisers’ endorsement follows the Food and Drug Administration’s authorization of the shots last week. It is one of the last steps before the Moderna shot would be more broadly available in doctors’ offices, pharmacies and vaccine clinics. Many states and vaccination sites wait for the CDC’s signoff before providing the inoculations. It typically follows the recommendations of its Advisory Committee on Immunization Practices but doesn’t have to. The panel is made up of pediatricians, epidemiologists and other health experts.
24th Jun 2022 - The Wall Street Journal

U.S. CDC confirms evidence of local monkeypox transmission

The U.S. Centers for Disease Control and Prevention (CDC) said there was evidence of local transmission of monkeypox, in addition to reports of cases where people had traveled abroad. The cases are mainly occurring in men who have sex with men, but women are also getting infected, CDC staff member Dr. Agam Rao said at a panel meeting on Thursday. Monkeypox, a viral infection that causes skin lesions, is endemic in certain parts of Africa. But the current outbreak has hit countries where the virus does not usually spread, sparking concern.
24th Jun 2022 - Reuters

South African biotech company to develop first African-owned Covid-19 vaccine

A year after the creation of the mRNA Vaccine Technology Transfer Hub, a South African biotech company has teamed up with a Belgium-based firm to develop an African Covid-19 vaccine. South Africa’s Afrigen Biologics and Belgium’s Univercells will develop the first African-owned Covid-19 shot as part of a broader effort to reduce the continent’s reliance on other regions for vaccines. During the signing of the agreement on Tuesday, Afrigen, based in Cape Town, said it is working to facilitate the production of mRNA vaccines at more than 15 manufacturing sites in low- and middle-income nations worldwide.
23rd Jun 2022 - ZAWYA

Scientists probe Japan's remarkable COVID success in hunt for new vaccine to protect some of the most vulnerable

Japan's notable coronavirus pandemic resilience has generated scores of possible explanations, from the country's preference for going shoeless indoors, to the purportedly low-aerosol-generating nature of Japan's quiet conversation, to its citizens' beneficial gut bacteria. Even irreligiousness — said to have spared the Japanese from exposure to crowded houses of worship — has been touted as a virtue in the age of COVID-19. Despite having the world's oldest population, with almost one in three residents 65 or older, Japan has had fewer COVID fatalities per capita than almost any other developed nation.
23rd Jun 2022 - CBS News

Valneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europe

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age. The European Commission will review the CHMP recommendation, and a decision on the marketing authorization application for VLA2001 is expected shortly. If granted, this will be the first COVID-19 vaccine to receive a standard marketing authorization in Europe.
23rd Jun 2022 - Associated Press

Moderna’s Covid-19 Vaccine for Kids 6 to 17 Years Faces CDC Review

Advisers to the Centers for Disease Control and Prevention are set to decide whether to recommend Moderna’s Covid-19 vaccine for children ages 6 to 17 years. Children in the age group already have access to Covid-19 vaccines made by Pfizer and its partner BioNTech. The advisers are discussing whether Moderna’s shot should also be made available for that age range. The advisers’ meeting follows the Food and Drug Administration’s authorization of the shots last week.
23rd Jun 2022 - Wall Street Journal

EU watchdog backs marketing authorisation for Valneva's COVID-19 shot

Valneva's COVID-19 vaccine was endorsed by the European Medicines Agency (EMA) on Thursday, although the French company's contract with the European Commission to supply the dose hangs in the balance. The original deal was for up to 60 million doses. But due to application delays and countries in Europe already having excess supply, the Commission has signalled that it wants to amend the agreement for a much smaller number of doses
23rd Jun 2022 - Reuters.com

Omicron-specific COVID vaccines on the horizon, Pfizer chief says

COVID-19 vaccines that specifically target the Omicron and other variants are under development, Pfizer Inc's (PFE.N) chief executive said on Wednesday, adding that the company will be able to quickly adapt shots as the novel coronavirus mutates. While the ultimate approval decisions rest with U.S. regulatos, "we are ready for that," the drugmaker's CEO Albert Bourla told MSNBC in an interview, noting that the Food and Drug Administration is convening a meeting later this month.
23rd Jun 2022 - Reuters.com

Nearly 1 in 5 adults who had COVID have lingering symptoms - U.S. study

Nearly 1 in 5 American adults who reported having COVID-19 in the past are still having symptoms of long COVID, according to survey data collected in the first two weeks of June, U.S. health officials said on Wednesday. Overall, 1 in 13 adults in the United States have long COVID symptoms lasting for three months or more after first contracting the disease, and which they did not have before the infection, the data showed.
23rd Jun 2022 - Reuters.com

Monkeypox News: Chelsea Clinic to Offer Vaccines in NYC to Vulnerable Groups

New York health officials will begin offering monkeypox vaccination to vulnerable groups at a temporary clinic in the city, where 28 cases have been identified as of Wednesday. New Yorkers who may have been exposed to monkeypox can get the vaccine, city health officials said Thursday. Eligible groups include “all gay, bisexual, and other men who have sex with men (cisgender or transgender) ages 18 and older who have had multiple or anonymous sex partners in the last 14 days,” the health department said in a statement. While shots were earlier offered to close contacts of confirmed cases, the department is expanding availability to eligible people who may have been exposed.
23rd Jun 2022 - Bloomberg

Paxlovid shown effective against visits for severe COVID-19

Pfizer's antiviral drug Paxlovid was tied to very few COVID-related visits to the emergency department (ED) or hospital, but people in socially vulnerable US regions are less likely to receive it or a similar COVID-19 drug, according to two studies published yesterday in Morbidity and Mortality Weekly Report (MMWR).
22nd Jun 2022 - CIDRAP

Moderna 2-strain booster shows strong subvariant antibody response

Moderna reported that the bivalent (two-strain) mRNA vaccine it developed against Omicron showed a strong neutralizing antibody response against the Omicron BA.4 and BA.5 subvariants and that it will seek regulatory approval in the coming weeks. Moderna's bivalent vaccine contains its original vaccine plus a strain that targets Omicron and its subvariants. The announcement comes amid rising BA.4 and BA.5 levels worldwide
22nd Jun 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Jun 2022

View this newsletter in full

Are the Russian covid-vaccine results accurate?

Dr Sheldrick’s team published their analysis on June 20th in the American Journal of Therapeutics. It was motivated by concerns that other researchers had raised earlier about one particular pattern in the Sputnik V paper: the vaccine’s efficacy was almost identical in each of the five age groups shown. The Russian scientists’ answer was that these results reflected a true efficacy that did not differ by age. But clinical trials are usually affected by all sorts of random circumstances, known as “noise” in the jargon. The implication is that, in this particular trial, the various sources of noise cancelled one another out in a way that generated a pattern of equivalent efficacy in all age groups.
22nd Jun 2022 - The Economist

Covid-19: Risk of mutated variants among immunocompromised patients, new study shows

Immunocompromised patients tend to develop chronic coronavirus infections, leading to highly mutated variants that bear multiple antibody-resistant mutations, according to a new study carried out by a research team at Tel Aviv University, Israel. The study involved an examination of chronic COVID-19 patients at the Tel Aviv Sourasky Medical Center (“Ichilov Hospital”) and was published this week in Nature Medicine. The researchers found that a weakened antibody response, particular in the lower airways of these chronic patients, may prevent full recovery from the virus and drive the virus to mutate many times during a lengthy infection. They explained that the virus’ ability to survive and reproduce in the immunosuppressed patient’s body without restriction leads to the evolution of many variants.
22nd Jun 2022 - The Brussels Times

Biological E has place in India's COVID-19 vaccine market following Corbevax' approval

The Drugs Controller General of India (DCGI) recently approved Biological E’s Corbevax vaccine as the first heterogeneous COVID-19 booster vaccine in India for adults above 18 years who have received two shots of Covaxin or Covishield. Corbevax has the added advantage of scalability and thermostability, making it suitable for deployment in low-resource settings, says GlobalData.
22nd Jun 2022 - The Pharma Letter

Afrigen, Univercells partner to develop African-owned Covid-19 vaccine

Afrigen Biologics has signed an agreement with the Univercells Group to develop the first African-owned Covid-19 vaccine. The partnership will focus on developing a new messenger ribonucleic acid (mRNA) vaccine leveraging intellectual property (IP) from both parties, as well as a new IP and boosting access to the shot. mRNA specialist eTheRNA will extend support to Afrigen and Univercells in the partnership. The firms will jointly work to address two key challenges, the lack of domestic cost-efficient manufacturing and the requirement for cold- or super-cold chains.
22nd Jun 2022 - Pharmaceutical Technology

Moderna calls for approval of two-strain Covid vaccine booster

Although the vaccine did not elicit as many antibodies to the new subvariants as it did to the original Omicron, suggesting its efficacy may already be declining, Moderna still feels there would be more of a benefit than not
22nd Jun 2022 - Financial Times

COVID-19 vaccine from Moderna 'provides good clinical protection' against Omicron subvariants

Omicron subvariants BA.4 and BA.5 are becoming the dominant forms of COVID-19 in Australia and abroad. New data from Moderna shows an updated booster tailored to Omicron generates high levels of antibodies against BA.4 and BA.5. Moderna's chief medical officer says, pending approval, the new booster could be supplied to Australia in August
22nd Jun 2022 - ABC News

Scientists evaluate JNK inhibitors in treating moderate to severe COVID-19 patients

Janus kinase (JNK) inhibitors with antiviral and anti-inflammatory properties have shown promising outcomes in treating symptomatic coronavirus disease 2019 (COVID-19) patients. In a systematic review article published in the journal Cochrane Database of Systematic Reviews, scientists have described the clinical outcomes in hospitalized COVID-19 patients who have been treated with JNK inhibitors together with standard of care.
22nd Jun 2022 - News-Medical.Net

Covid-19: How has the pandemic differed across the four UK nations?

Although the overall course of the pandemic has been similar across the UK, there have been instances when the countries’ trajectory has diverged. In the first wave Northern Ireland had far fewer deaths and hospital admissions. Lockdown restrictions were similar across the UK at this time. One possible explanation for the divergence is that lockdown began at a slightly earlier stage in the pandemic in Northern Ireland, reducing the size of the peak there. In the second wave Scotland had relatively fewer cases, hospital admissions, and deaths than England and Wales. Scotland also had the most consistent set of restrictions in place between September and December 2020, which may have helped to delay the spread of the alpha variant (which was dominant in England by the beginning of December but not in Scotland until January 2021).34 Northern Ireland had a slightly later peak in cases in this wave, which may have contributed to lower mortality, as a result of the vaccination programme reducing severe disease. Northern Ireland’s younger population may also have been a factor in its lower cumulative mortality. From the middle of 2021 to February 2022 Northern Ireland had consistently higher rates of hospital admission for covid-19 than elsewhere in the UK, although case rates and mortality have been broadly similar. This suggests that hospital care for patients with covid-19 may have been organised differently in Northern Ireland, resulting in a higher admission rate. Another possibility is that hospital acquired covid-19, which has been a significant concern,5 may be a particular problem in hospitals in Northern Ireland. In February and March 2022 Scotland had the highest case rates and a rapid increase in hospital admissions, despite retaining restrictions longest in response to omicron.
22nd Jun 2022 - The BMJ

Moderna booster candidate shows strong response against Omicron subvariants

Moderna Inc said on Wednesday that an updated version of its COVID-19 vaccine designed to target the Omicron variant also generated a strong immune response against the fast-spreading Omicron subvariants BA.4 and BA.5, which have gained a foothold in the U.S. in recent weeks. The updated vaccine, which Moderna is hoping will be approved for use as a booster shot for the fall, is a bivalent vaccine, meaning it contains vaccine designed to target two different coronavirus variants - the original variant from 2020 and the Omicron variant that was circulating widely last winter.
22nd Jun 2022 - Reuters

Pfizer sued for patent infringement over COVID-19 drug Paxlovid

Pfizer Inc's blockbuster COVID-19 treatment Paxlovid violates an Enanta Pharmaceuticals Inc patent for its COVID drug still in development, according to a lawsuit filed Tuesday in Boston federal court. Watertown, Massachusetts-based Enanta told the court it received the patent for its antiviral medication last week based on applications dating from July 2020. The company said it began human testing for its once-daily, oral COVID treatment in February, and that the Food and Drug Administration fast-tracked its review in March. Enanta requested an unspecified amount of money damages from Pfizer, including royalties. It also said in a statement that it was not asking the court to block Pfizer from selling Paxlovid. Paxlovid is an oral antiviral pill for high-risk patients that is intended to stave off serious complications from COVID-19. Pfizer said last month it expects to make $22 billion from Paxlovid sales this year. The company did not immediately respond to a request for comment on the lawsuit.
22nd Jun 2022 - Reuters

Moderna CEO: COVID variant vaccine to be ready for shipping in August

Moderna's COVID-19 variant vaccine will be ready to ship in August as the company has been making shots ahead of approval, Chief Executive Stephane Bancel told Reuters on Wednesday, adding that the only bottleneck to supply was a regulatory one. "Our goal is as early as August given we're going to file all the data in June, by the end of June... hopefully in the August timeframe, the vaccine is authorised," Bancel said in an interview.
22nd Jun 2022 - Reuters

Moderna’s New Covid-19 Shot Shows Promise Against Omicron Subvariants

The shot targeting both Omicron and the original virus strain produced a strong immune response against subvariants BA.4 and BA.5, the company said
22nd Jun 2022 - The Wall Street Journal

Women more likely to have long COVID, different symptom profile

Women are significantly more likely than men to experience long COVID, with symptoms that follow a distinct clinical pattern, researchers reported today. They said more efforts are needed to explore sex differences in outcomes, including greater risks of exposure for some jobs. The researchers from the Johnson & Johnson Office of the Chief Medical Officer reported their findings yesterday in Current Medical Research and Opinion, a peer-reviewed journal.
22nd Jun 2022 - CIDRAP

Nearly 1 in 5 adults who had COVID have lingering symptoms - U.S. study

UK Polio Spread Detected With Vaccine-Derived Virus Found in London Sewage

Britain’s polio-free status could be at risk for the first time in almost two decades after several samples of vaccine-derived poliovirus were found during routine London sewage testing. Several closely related viruses were found in samples taken in north and east London between February and May. The findings suggest some spread between closely linked individuals and the virus has continued to evolve and is now classified as a vaccine-derived poliovirus type 2, the UK Health Security Agency said Wednesday. Polio can on rare occasions cause serious illness, such as paralysis, in people are not fully vaccinated. No cases of polio or associated paralysis have been reported, according to the agency.
22nd Jun 2022 - Bloomberg

More vulnerable people receiving fewer COVID pills - U.S. study

People in socially and economically disadvantaged regions are about half as likely to receive an oral antiviral COVID-19 pill than residents of wealthier zip codes, according to a U.S. government study published on Tuesday. The findings by the U.S. Centers for Disease Control and Prevention (CDC) revealed this disparity even as there were more dispensing sites located in high-vulnerability U.S. zip codes than in the more advantaged areas.
21st Jun 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Jun 2022

View this newsletter in full

COVID and Kidney Pain: How COVID-19 Can Affect Kidneys

COVID-19 can cause a variety of different symptoms. However, when you think of COVID-19 symptoms, kidney pain probably isn’t one of them. While it’s possible for COVID-19 to cause kidney damage, this condition isn’t typically associated with kidney pain. Keep reading to discover more about what we know so far about COVID-19 and the kidneys.
22nd Jun 2022 - Healthline

U.S. COVID vaccines start to roll out for young children

The United States has begun distributing COVID vaccines for children as young as six months around the country, and availability of the shots will improve in the coming days, according to White House COVID-19 response coordinator Dr. Ashish Jha. U.S. regulators authorized Moderna Inc's two-dose vaccine for children aged six months to five years and the Pfizer-BioNTech three-shot regimen for children aged six months to four years late last week.
22nd Jun 2022 - Reuters

After maternal COVID vaccination, infants have persistent anti-SARS-CoV-2 antibodies at 3 months

A recent article published in the journal Clinical Infectious Diseases assessed the kinetics of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies derived from mothers among infants in association with the timing of prenatal SARS-CoV-2 vaccination.
21st Jun 2022 - News-Medical.Net

Afrigen, Univercells Team Up to Develop African Covid Vaccine

South African biotech company Afrigen Biologics will work with a Belgian partner to develop the first African-owned Covid-19 shot as part of a broader effort to reduce the continent’s reliance on other regions for vaccines. Afrigen and the Univercells Group aim to build on expertise developed through the World Health Organization’s messenger RNA vaccine hub, the companies said in a statement Tuesday. Afrigen, based in Cape Town, said it’s working to facilitate the production of mRNA vaccines at more than 15 manufacturing sites in low- and middle-income nations across the world. Africa, which imports about 99% of all the shots it needs, was left far behind wealthier nations in securing shots during the pandemic with manufacturing concentrated in just a handful of countries. The partners said they’ll seek to develop vaccines that are cheaper to produce and easier to store and distribute in rural and remote locations where few people have been vaccinated.
21st Jun 2022 - Bloomberg

Ainos COVID-19 Antigen Self-Test Receives Approval for Sale in Taiwan

Ainos, Inc. a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that the Company has begun marketing the Ainos SARS-CoV-2 Antigen Rapid Self-Test (“COVID-19 Antigen Self-Test Kit” or “the Test”) under an Emergency Use Authorization (“EUA”) issued by the Taiwan Food and Drug Administration (“TFDA”) on June 13, 2022 to Taiwan Carbon Nano Technology Corporation (“TCNT”), the manufacturer and product co-developer of the Test in conjunction with Ainos. Ainos is the exclusive master sales and marketing agent for the COVID-19 Antigen Self-Test Kit.
21st Jun 2022 - The Associated Press

RMI's COVID-19 vaccine partnership with Acacium proves a success

The joint aim of the companies was to provide vaccines to vulnerable communities Remote Medical International (RMI) – which specialises in protecting the health of workers in diverse areas across the world – partnered with healthcare solutions company Acacium Group to provide vaccinations in areas of notable need during 2021-22. Their joint aim was to deliver mobile vaccination and COVID-19 test processing units throughout the Midlands and South East of the UK during the pandemic. The companies delivered mobile-testing with a results turnaround time of less than three hours and, throughout the course of their deployment, processed in the excess of 200,000 tests
21st Jun 2022 - PharmaTimes

Paxlovid of no benefit to low risk patients with COVID-19

Paxlovid is of no benefit to patients at a low risk of either being hospitalised or death after infection with COVID-19. According to the results of a press release from the manufacturer, Pfizer, paxlovid does not benefit patients who are either unvaccinated or vaccinated and who are deemed not at a high risk of severe complications such as hospitalisation or death if infected with COVID-19. Paxlovid is a protease inhibitor antiviral therapy against COVID-19 and was developed to be taken orally, at the first sign of infection or at first awareness of an exposure. The early use of the drug could therefore help patients avoid severe illness and which might lead to hospitalisation or death, or avoid disease development following contact with an infected individual.
21st Jun 2022 - Hospital Healthcare Europe

Some Omicron sub-variants escaping antibodies from Sinopharm shot, Chinese study says

A small Chinese study detailed in The Lancet Infectious Diseases journal showed neutralising antibodies against some Omicron sub-variants were largely undetectable after two doses of a Sinopharm COVID-19 vaccine, with a booster shot only partly restoring them. The study comes as China, which has approved only locally developed COVID shots including the Sinopharm vaccine, strives to improve vaccination rates, maintaining a "dynamic zero COVID" policy aimed at eradicate all outbreaks while many countries have adopted an approach of learning to live with the virus
21st Jun 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Jun 2022

View this newsletter in full

Covid-19: Long covid risk is lower with omicron than delta, researchers find

The risk of developing long covid is lower among people with the omicron variant of SARS-CoV-2 than with delta, shows an analysis of self reported data to the UK ZOE covid app.Researchers from King’s College London looked at data logged by 56 003 adults who tested positive between 20 December 2021 and 9 March 2022, when the omicron variant was dominant. They compared these with 41 361 who tested positive between 1 June 2021 and 27 November 2021, when the delta variant was most common. Among the cases in the omicron period, 2501 people (4.5%) reported they had experienced long covid, defined as having new or ongoing symptoms four weeks or more after they had tested positive. This compared with 4469 (10.8%) of people in the delta period, according to the analysis, published as a letter in the Lancet.
18th Jun 2022 - The BMJ

Can We Develop a Covid-19 Vaccine That Lasts?

Though most vaccines take years to develop, the Covid shots now in use were created in record time—in a matter of months. For health authorities and a public desperate for tools to deal with the pandemic, their speedy arrival provided a huge lift, preventing hospitalizations and deaths while helping people to escape lockdowns and return to work, school and many other aspects of pre-Covid life. But the Covid vaccines don’t last nearly as long as shots given for other viral illnesses such as polio, mumps and hepatitis, which remain effective for years or decades. Even more worrisome to some scientists and public health officials, the current vaccines don’t fully protect against infections, which hurts their overall effectiveness and gives the virus an opportunity to mutate into more contagious and lethal strains.
18th Jun 2022 - The Wall Street Journal

Monkeypox Cases Could Spread Unseen in US If 'Testing Bottlenecks' Don't Improve

US testing for monkeypox is insufficient to determine how widespread the virus is and where new cases are cropping up, according to infectious disease experts and advocates concerned about a sluggish response to the outbreak that’s already hit 32 countries. While government labs have the capacity to test as many as 8,000 samples a week, they’re only using 2% of that capability, suggesting that about 23 monkeypox tests are being performed a day, said James Krellenstein, the cofounder of PrEP4All, an HIV advocacy group that widened its focus during the pandemic. Much more testing is needed to find out where the pathogen is and how fast it’s moving, he said.
18th Jun 2022 - Bloomberg

Omicron less likely to cause long COVID, UK study says

The Omicron variant of coronavirus is less likely to cause long COVID than previous variants, according to the first peer-reviewed study of its kind from the United Kingdom. Researchers at King's College London, using data from the ZOE COVID Symptom study app, found the odds of developing long COVID after infection were 20% to 50% lower during the Omicron wave in the UK compared to Delta. The figure varied depending on the patient's age and the timing of their last vaccination.
18th Jun 2022 - Reuters

WHO panel backs use of Omicron-adapted vaccine as booster dose

A modified coronavirus vaccine that targets the Omicron variant can be administered as a booster dose to broaden immunity, a technical advisory group set up the World Health Organization said on Friday. Such a variant-adapted vaccine may benefit those who have already received the primary series of shots, the agency's panel on COVID-19 Vaccine Composition said, citing available data. The vaccines could be considered for use globally by the agency once they get emergency use authorization or an approval by a stringent national regulatory authority.
18th Jun 2022 - Reuters

Early Omicron infection unlikely to protect against current variants

People infected with the earliest version of the Omicron variant of the coronavirus, first identified in South Africa in November, may be vulnerable to reinfection with later versions of Omicron even if they have been vaccinated and boosted, new findings suggest. Vaccinated patients with Omicron BA.1 breakthrough infections developed antibodies that could neutralize that virus plus the original SARS-CoV-2 virus, but the Omicron sublineages circulating now have mutations that allow them to evade those antibodies, researchers from China reported on Friday in Nature.
18th Jun 2022 - Reuters

COVID vaccine rollout for U.S. children close after CDC panel vote

The U.S. Centers for Disease Control and Prevention on Saturday recommended COVID-19 vaccines for children as young as six months, allowing a nationwide rollout to start next week. The CDC's move came after a panel of advisers to the institution voted earlier on Saturday to recommend COVID-19 vaccines for those children. "We know millions of parents and caregivers are eager to get their young children vaccinated, and with today's decision, they can," said Rochelle Walensky, the CDC director, in a statement.
18th Jun 2022 - Reuters

EU drugs watchdog begins review of Moderna's variant COVID vaccine

The European Medicines Agency (EMA) started a rolling review on Friday of a variant-adapted COVID-19 vaccine from Moderna (MRNA.O), as coronavirus cases linked to Omicron sub-variants see an uptick in the region. U.S.-based Moderna's so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID, the original strain first identified in China, and the Omicron variant. Last week, Moderna said its bivalent vaccine produced a better immune response against Omicron than the original shot.
17th Jun 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Jun 2022

View this newsletter in full

More South Australians now able to test for different viruses at COVID drive-through sites

More vulnerable South Australians will now be able to test for 12 different viruses, such as influenza, alongside their COVID-19 tests. The test can detect a dozen viruses including COVID, influenza and respiratory syncytial virus. Flu cases are skyrocketing in SA. The multi-virus tests take about 24 hours to process SA Pathology has doubled its multi-virus testing from 500 to 1,000 a day to support doctors to give early diagnosis and treatment to at-risk patients. Tests are available at drive-through testing clinics and at private pathologies with a GP referral, which can also be obtained via telehealth. Health Minister Chris Picton said multi-virus testing has been available since the start of the pandemic, but spiking flu cases have prompted health authorities to provide more testing.
17th Jun 2022 - ABC News

WHO getting monkeypox tests for Africa, urges vaccine readiness

The World Health Organization (WHO) is in the process of procuring thousands of monkeypox tests for Africa but is not recommending mass vaccination at this stage, WHO Africa Director Matshidiso Moeti said on Thursday. She added that the continent should be prepared for vaccination should the need arise.
16th Jun 2022 - Reuters

EMA begins rolling review of Pfizer-BioNTech’s Covid-19 vaccine

The European Medicines Agency (EMA) has commenced a rolling review of Pfizer and BioNTech’s variant-adapted version of their Covid-19 vaccine, Comirnaty. This review is preliminarily based on chemistry, manufacturing, and controls (CMC) data submitted to the EMA recently. As the development of the adapted vaccine advances and clinical data become available, including findings on immunogenicity against Omicron and its subvariants, it will be included in the rolling submission. By initiating a rolling review, the regulatory agency will be able to analyse these findings when they become available. The rolling review will progress until sufficient data for a formal application is obtained.
16th Jun 2022 - Pharmaceutical Technology

Fauci: NIH is researching a pan-coronavirus vaccine to combat COVID-19 twists, new threats

Dr. Anthony Fauci, speaking by video-link because he contracted COVID-19, told Congress on Thursday his agency is studying vaccines that better target the omicron variant and it will be “paramount” to develop a new generation of shots that can tackle a range of coronaviruses. Dr. Fauci said existing vaccines can stave off severe disease from spinoffs of the virus first detected in China, especially if someone is boosted. But the National Institutes of Health is trying to increase the breadth of the vaccines’ immune response and improve children’s uptake. “Looking ahead to the anticipated emergence of new variants, the importance of developing the next generation of coronavirus vaccines is paramount,” said Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases. “This virus is changing, and we need to keep up with it.”
16th Jun 2022 - Washington Times

Researchers evaluate artemisinin for COVID-19 management

A study observed that artesunate-mefloquine displayed high anti-SARS-CoV-2 activity with approximately 72.1 ± 18.3% inhibition. Additionally, other ACTs such as artesunate-amodiaquine, artesunate-pyronaridine, artemether-lumefantrine, and dihydroartemisinin-piperaquine also inhibited SARS-CoV-2 by 27.1 to 34.1%. This indicated that ACT drugs could be effectively used for COVID-19 treatment. Artesunate was also found to inhibit the production of interleukin-1B (IL-1B), IL-6, and IL-8. Since high IL-6 levels in COVID-19 patients have been attributed to the cytokine release syndrome, controlling the levels of IL-6 could potentially reduce the severity of COVID-19. Overall, the study revealed that A. annua, and artemisinin and its derivatives such as artemether and artesunate could potentially inhibit SARS-CoV-2. The researchers believe that Artemisia-based treatment options could be used to boost immunity and improve tolerance against viral infections such as COVID-19.
16th Jun 2022 - News-Medical.Net

Valneva reaches COVID-19 vaccine settlement with UK government, while EU deal remains uncertain

Valneva has reached a settlement with the UK government over an abandoned COVID-19 vaccine contract. Meanwhile, the future of its COVID-19 vaccine in the EU could become clearer next week after an EMA committee vote.
16th Jun 2022 - BioPharma-Reporter.com

Valneva reaches settlement with Britain on COVID-19 vaccine deal termination

French drugmaker Valneva said on Wednesday it reached a settlement agreement with the British government linked to the termination of the supply agreement for its COVID-19 vaccine candidate VLA2001. Valneva said in September that it had received a termination notice from the British government of its COVID-19 vaccine supply deal, sending its shares plunging 35% that day. The settlement agreement resolves certain matters relating to the obligations of the company and the British government following the termination of the supply agreement, Valneva said.
16th Jun 2022 - Reuters

Despite efficacy doubts, FDA advisors endorse Pfizer, Moderna COVID shots for preschoolers

An FDA advisory committee of independent specialists has recommended by a unanimous vote that the Pfizer and Moderna COVID-19 vaccines be sanctioned for preschoolers. While the blessing sets up the vaccines for long-awaited FDA authorizations, questions remain about how effective the shots will be given the rapidly evolving virus. The panel based its recommendation on clinical data gathered early this year when the omicron variant was predominant. Months later, the BA.4 and BA.5 subvariants of omicron are quickly changing the COVID landscape. CDC data show that the new strains account for 21% of new infections. Just five weeks ago, BA.4 and BA.5 accounted for just 1% of cases.
16th Jun 2022 - Fiercepharma

FDA advisers endorse 1st COVID-19 shots for kids under 5

The first COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday. The Food and Drug Administration’s vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for the littlest kids. The outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5 — that’s roughly 18 million youngsters. They are the last age group in the U.S. without access to COVID-19 vaccines and many parents have been anxious to protect their little children. If all the regulatory steps are cleared, shots should be available next week.
15th Jun 2022 - Reuters

People who caught Covid in first wave get ‘no immune boost’ from Omicron

People who caught Covid during the first wave of the pandemic get no boost to their immune response if they subsequently catch Omicron, a study of triple vaccinated people reports. Experts say that while three doses of a Covid jab help to protect individuals against severe outcomes should they catch Omicron, previous infections can affect their immune response. “If you were infected during the first wave, then you can’t boost your immune response if you have an Omicron infection,” said Prof Rosemary Boyton, of Imperial College London, a co-author of the study. The team also found an Omicron infection offered little extra protection against catching the variant again. “When Omicron started flying around the country, people kept saying that’s OK, that will improve people’s immunity,” said Boyton. “What we’re saying is it’s not a good booster of immunity.”
15th Jun 2022 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Jun 2022

View this newsletter in full

Moderna to Study Its Covid-19 Vaccine in Babies as Young as 3 Months

Moderna Inc. is planning to test its Covid-19 vaccine in babies 3 months to 6 months old, the youngest age group studied to date. The Cambridge, Mass., company said Wednesday it is in the final stages of planning the study, to be called BabyCove and expected to begin enrolling as many as 700 babies in September. BabyCove would be the first study of Moderna’s vaccine in infants younger than 6 months. Moderna’s vaccine is authorized for use in adults 18 and older. The company has requested expanding the vaccine’s use to children ages 6 months through 17 years, and a decision by the Food and Drug Administration on that request could come within days.
15th Jun 2022 - The Wall Street Journal

WHO to Convene Emergency Meeting on Monkeypox Amid Spread

The World Health Organization will hold an emergency meeting to assess whether the current spread of monkeypox constitutes a public health emergency of international concern, or PHEIC. A special committee will meet next week to advise on the spread in non-endemic countries, Hans Kluge, regional director of the WHO for Europe, said at a media briefing Wednesday. A PHEIC is the WHO’s highest alert level, and such a declaration can be used to encourage nations to cooperate on countermeasures, while letting the agency recommend steps such as travel advisories.
15th Jun 2022 - Bloomberg

NTAGI to review Covaxin, Corbevax vaccine data for 6-12 years on Thursday

Government advisory panel NTAGI will meet on Thursday to review data on Covaxin and Corbevax vaccines for the 6-12 age group and also deliberate on reducing the gap between the second and precaution doses from the current nine to six months. The National Technical Advisory Group on Immunisation (NTAGI) will hold its meeting amid a fresh spike in COVID-19 cases in the country. Currently, those aged 12 years and above are vaccinated against COVID-19.
15th Jun 2022 - Business Standard

Vaccine makers claims efficacy against Omicron variant of Covid-19

With Omicron and its sub-variants spreading rapidly across the globe, vaccine makers have started claiming efficacy of their Covid-19 vaccines against this Sars-CoV-2 variant.
15th Jun 2022 - Business Standard

Covid-19: Omicron infection is poor booster to immunity, study finds

People infected with the omicron variant show poor immunity boosting against future covid-19 infection, researchers have found. This may explain why breakthrough and repeat infections have been a common feature of the omicron wave of the pandemic, even among people who have been triple vaccinated, said the research team. Omicron is “an especially stealthy immune evader” said Danny Altmann, study coauthor from Imperial College London. “Not only can it break through vaccine defences, it looks to leave very few of the hallmarks we’d expect on the immune system,” he said. “It’s more stealthy than previous variants and flies under the radar, so the immune system is unable to remember it.”
15th Jun 2022 - The BMJ

Pfizer halts Paxlovid trial in less vulnerable COVID patients after failing to find evidence of benefit

Pfizer’s Paxlovid has proven useful in COVID-19 patients at high risk of severe disease. But the antiviral drug may not help less vulnerable patients. Pfizer has stopped enrollment into the EPIC-SR trial that’s been evaluating Paxlovid in standard-risk patients, the company said Tuesday. These include unvaccinated adults without additional risk and vaccinated people who have at least one risk factor for progressing to severe disease. The clinical trial previously flopped on its primary goal, showing the Pfizer antiviral was no better than placebo at sustaining symptom relief for four consecutive days.
15th Jun 2022 - FiercePharma

FDA panel unanimously backs Moderna’s Covid vaccine for children ages 6 to 17

A panel of experts convened by the Food and Drug Administration voted unanimously Tuesday to recommend the agency authorize the Moderna Covid vaccine for children ages 6 to 17. The authorization would mirror the current emergency use authorization of the Covid vaccine developed by Pfizer and BioNTech, which is authorized for individuals 6 years and older. “I believe this vote, and I am happy to say it was unanimous, is standing up for vulnerable populations that merit protection against this virus,” said Ofer Levy, a member of the FDA’s expert panel and director of the precision vaccines program at Boston Children’s Hospital. “I believe this will provide families with an important option.”
15th Jun 2022 - STAT News

Pfizer’s Paxlovid study fails to answer key questions over benefit for broader populations

Pfizer said Tuesday that a much-watched study of its antiviral Paxlovid in patients who have Covid but don’t have risk factors for severe disease failed to show a benefit in speeding alleviation of Covid symptoms, but did seem to prevent doctor’s visits and hospitalizations. Additionally, because of the small number of hospitalizations overall in the study, it failed to produce a statistically significant finding on whether patients who had previously been vaccinated against Covid were hospitalized less often if they received Paxlovid. The data in no way invalidate earlier results that show that Paxlovid prevents hospitalizations and saves lives in patients at high risk of severe Covid.
15th Jun 2022 - STAT News

Severe covid-19 symptoms linked to more than 1300 genetic variants

More than 1000 genes may contribute to a person’s risk of developing severe covid-19, on top of life circumstances such as their age, ethnicity and any health conditions. Most of the genes, discovered in a study of more than 1 million people, affect the functioning of two kinds of immune cell. If the results are confirmed, they could inform a test that assesses a person’s risk of getting badly ill with covid-19, says Johnathan Cooper-Knock at the University of Sheffield, UK. “We know there are young people who are otherwise fit that get severe covid,” he says. “We are trying to get at the genetic determinants that put people at risk irrespective of the more obvious things.” Cooper-Knock’s team used artificial intelligence to analyse results from a global data set called the COVID-19 Host Genetics Initiative, a genetics project run by a group of researchers and companies.
14th Jun 2022 - New Scientist

People who caught Covid in first wave get ‘no immune boost’ from Omicron

How long is your COVID vaccine good for? You can soon find out, thanks to a new test that informs patients of their immunity’s ‘magnitude and duration’

Until recently, it’s been nearly impossible to say. Immunity, whether from vaccine or prior infection, is thought to wane after three or four months, but it varies by person. That knowledge is based on what’s known about typical antibody response—but antibodies are only half of the picture. The other half: T-cell response, which hasn’t been examined in patients nearly as often owing to technical challenges. Now that response can be tested affordably and en masse, researchers at Mount Sinai Health System in New York say. Along with researchers at Duke-NUS Medical School in Singapore, they developed a rapid blood test called the dqTACT assay that measures the activation of such cells in response to COVID. The test will allow for mass monitoring of the population’s immunity and effectiveness of vaccines new and old, they said in a study published Tuesday in Nature Biotechnology.
14th Jun 2022 - Fortune

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Jun 2022

View this newsletter in full

The next virus pandemic threat (and what the experts are doing about it)

Two years ago the first human trials of the University of Oxford’s game-changing Covid-19 vaccine were just under way, only five months after the pandemic virus was identified. Bill Gates has hailed this super-rapid progress as “miraculous”. The scientists responsible prefer to put it down to preparation. Back then no one was even sure that a vaccine against Covid-19 could work. Now, having succeeded in creating several of them, the knowledge accrued when developing such drugs is being put to good use on new projects. In America, for instance, scientists in collaboration with BioNTech, the German firm behind the Pfizer coronavirus jab, are trialling a vaccine to treat pancreatic cancer, the deadliest common cancer, using the same mRNA technology as was used in Covid jabs.
14th Jun 2022 - The Times

Covid vaccine protection wanes more quickly for cancer patients, finds study

The level of protection offered by Covid vaccination is lower for cancer patients than those in the general population, according to the UK Coronavirus Cancer Evaluation Project. The study, co-led by the Universities of Oxford, Birmingham and Southampton and the UK Health Security Agency (UKHSA), published in The Lancet Oncology, represents the first time that Covid vaccine effectiveness had been examined in people with cancer on this scale. It found that Covid vaccination was effective in most cancer patients, but the level of protection against Covid infection, hospitalisation and death was reduced over time. Three to six months after a second vaccination, protection was found to be reduced by nearly a third in cancer patients compared to people with no active or recent cancer.
14th Jun 2022 - Pulse Today

U.S. FDA advisers weigh Moderna COVID vaccine heart risk for young men

Moderna's COVID-19 vaccine may have a higher risk of heart inflammation in young men than the Pfizer/BioNTech shot, according to data presented on Tuesday to U.S. Food and Drug Administration advisers weighing its use for those aged 6 to 17. An FDA official told the expert panel that while the data showed a higher risk for the Moderna shot, the findings were not consistent across various safety databases and were not statistically significant, meaning they might be due to chance.
14th Jun 2022 - Reuters

Moderna COVID-19 vaccine's safety slightly bests Pfizer's

An observational study today in JAMA Internal Medicine reports a slightly better safety profile for the Moderna mRNA COVID-19 vaccine than for the Pfizer/BioNTech version in US veterans, but both vaccines had very good safety profiles. A team led by Harvard University researchers reviewed the electronic health records of 433,672 US Department of Veterans Affairs patients across the country who received their first dose of the Pfizer or Moderna COVID-19 vaccine from Jan 4 to Sep 20, 2021, with a second dose scheduled for 21 to 28 days later, depending on the vaccine. Median patient age was 69 years, 93% were men, 20% were Black, and 8% were Hispanic. Median follow-up was 223 days.
14th Jun 2022 - CIDRAP

Study finds vitamin D status and COVID-19 diagnosis shows inconsistent associations

A large study revealed no consistent associations between vitamin D status and COVID-19 outcomes such as infection, hospitalisation and death. There are inconsistent associations between vitamin D status and the diagnosis of COVID-19, hospitalisations and mortality according to the findings of a large cohort study by researchers from Faculty of Epidemiology & Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
14th Jun 2022 - Hospital Healthcare Europe

The severity of COVID-19 compared to seasonal influenza

In a recent study under review at the Archives of Virology journal and currently posted to the Research Square* preprint server, investigators in Israel assessed the disparities and similarities between seasonal influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections.
14th Jun 2022 - News-Medical.Net

Moderna COVID vaccine may pose higher heart inflammation risk - U.S. CDC

FDA advisers consider Moderna’s COVID shots for older kids

A government advisory panel met Tuesday to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens. The Food and Drug Administration’s outside experts will vote on whether Moderna’s vaccine is safe and effective enough to give kids ages 6 to 17. If the panel endorses the shot and the FDA agrees, it would become the second option for those children, joining Pfizer’s vaccine. The same expert panel will meet Wednesday to consider tot-sized shots from Moderna and Pfizer for the littlest kids, those under 5. Moderna’s COVID-19 vaccine has long been available for adults in the U.S. and elsewhere and dozens of countries offer it to children, too. In the U.S., children ages 12 to 17 would get two full-strength doses; ages 6 to 11 would get half-sized doses. The FDA held up Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. That’s mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. Moderna got extra scrutiny because its shots are a far higher dose..
14th Jun 2022 - The Associated Press

U.S. FDA advisers overwhelmingly back Moderna COVID vaccine for ages 6-17

Advisers to the U.S. Food and Drug Administration on Tuesday unanimously recommended that the agency authorize Moderna Inc's COVID-19 vaccine for children and teens aged 6 to 17 years of age. Around 77 million people in the United States have received at least a two-dose course of Moderna's vaccine, which has long been available for people aged 18 and older. The committee of outside experts is scheduled on Wednesday to consider the Moderna shot for children under 6, and Pfizer and BioNTech's COVID vaccine for children under 5 - and in both cases as young as 6 months.
14th Jun 2022 - Reuters

FDA Should Authorize Moderna’s Vaccine for Ages 6 to 17, Advisers Say

A panel of advisers to the Food and Drug Administration recommended the agency expand use of Moderna Inc.’s Covid-19 vaccine to children ages 6 through 17. The advisory committee voted 22-0 on Tuesday that the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older. “This vote is standing up for vulnerable populations that merit consideration in terms of protection against this virus,” said FDA committee member Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital. “I believe this will provide families an important option.”
14th Jun 2022 - The Wall Street Journal

To save global health, we need vaccine patent waivers now

Global health is on its deathbed. For almost two years, a handful of rich countries have resisted a life-saving proposal tabled by India and South Africa that could speed up global COVID-19 vaccination, but the new vaccine patent waiver proposal pushed by the European Union and the head of the World Trade Organization is worse than no deal at all, says Hugo López-Gatell.
14th Jun 2022 - Al Jazeera English

Covid-19 Variant Shot From Sanofi, GSK Shows Strong Response to Omicron in Studies

A Covid-19 vaccine developed by Sanofi SA and GSK PLC to target the Beta strain of the virus produced a stronger antibody response against variants of Omicron when given as a booster compared with certain first-generation shots, two studies have found. The results are the latest indication that tweaking vaccines can nudge antibody responses in the direction of new variants, possibly helping to shore up immunity as the virus mutates. The study results may also provide an opportunity for Sanofi and GSK, two vaccine giants that were late to develop Covid-19 immunizations, to play a role in providing booster shots. In the studies, the Beta-targeted vaccine induced a stronger antibody response to certain Omicron variants than first-generation vaccines, according to Sanofi. One study compared the Beta-targeted vaccine to the original vaccine produced by Pfizer Inc. and BioNTech SE. Neither study has yet been peer-reviewed.
13th Jun 2022 - The Wall Street Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Jun 2022

View this newsletter in full

EMA’s PRAC finds no link between mRNA Covid-19 vaccines and menstruation

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has found no link between messenger ribonucleic acid (mRNA) Covid-19 vaccines and the absence of menstruation (amenorrhea). The development comes after the committee analysed all the available findings, including cases reported during clinical trials, those reported spontaneously in Eudravigilance and data from the literature. Data also comprise the literature and cases of amenorrhea reported to EudraVigilance following dosing with the Covid-19 vaccines of Pfizer-BioNTech and Moderna, Comirnaty and Spikevax, respectively.
13th Jun 2022 - Pharmaceutical Technology

Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally Registered in Australia as a Booster in Individuals Aged 18 and Over

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Australian Therapeutic Goods Administration has granted provisional registration of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over. "Today's provisional registration for Nuvaxovid as a booster in Australia is an important step in ensuring broad global access to diversified vaccine options," said Stanley C. Erck, President and Chief Executive Officer, Novavax
13th Jun 2022 - Asia One

Ivermectin Has Little Effect on Recovery Time From Covid, Study Finds

The antiparasite drug ivermectin does not meaningfully reduce the time needed to recover from Covid, according to a large study posted online Sunday. It is the largest of several clinical trials to show that the drug, popular since the early pandemic as an alternative treatment, is not effective against the virus. The new trial, conducted by researchers at Duke University and Vanderbilt University, tested more than 1,500 people with Covid, about half getting the drug and the others a placebo. The study has not yet been published in a scientific journal. “Given these results, there does not appear to be a role for ivermectin outside of a clinical trial setting, especially considering other available options with proven reduction in hospitalizations and death,” Dr. Adrian Hernandez, the executive director of the Duke Clinical Research Institute who led the trial, said in a statement on Sunday night.
13th Jun 2022 - The New York Times

Vaccinated people who recovered from Omicron found to be best protected against BA.5

People vaccinated against COVID-19 and who recovered from an Omicron infection are best protected against the BA.5 subvariant that has been spreading, according to new findings by an Israeli hospital. Initial results of research by Sheba Medical Center showed those who were vaccinated and had been sick with Omicron developed the most antibodies against BA.5, the Kan public broadcaster reported Sunday. The report added that those who were either vaccinated and did not contract Omicron or vice versa had significantly fewer antibodies than people who were both inoculated and previously infected with the coronavirus variant.
13th Jun 2022 - The Times of Israel

Covid is making flu and other common viruses act in unfamiliar ways

At one point last month, children were admitted to Yale New Haven Children’s Hospital with a startling range of seven respiratory viruses. They had adenovirus and rhinovirus, respiratory syncytial virus and human metapneumovirus, influenza and parainfluenza, as well as the coronavirus — which many specialists say is to blame for the unusual surges. “That’s not typical for any time of year and certainly not typical in May and June,” said Thomas Murray, an infection-control expert and associate professor of pediatrics at Yale. Some children admitted to the hospital were co-infected with two viruses and a few with three, he said. More than two years into the coronavirus pandemic, familiar viruses are acting in unfamiliar ways. Respiratory syncytial virus, known as RSV, typically limits its suffocating assaults to the winter months.
13th Jun 2022 - The Washington Post

COVID Death Rates Explained, Dismal Booster Stats, and New Vaccines

On this episode of the COVID, Quickly podcast, we clear up some data misconceptions, get to the bottom of the booster uptake issue and talk Novavax.
13th Jun 2022 - Scientific American

Pfizer Vaccine Effective in Children Under 5, the F.D.A. Says

The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appeared to be effective in preventing Covid illness in children under 5, judging by the level of virus-blocking antibodies the shots induced. The agency’s evaluation was posted online ahead of Wednesday’s meeting of outside vaccine experts, summoned to recommend how the F.D.A. should rule on applications from both Pfizer and Moderna on vaccinating the nation’s youngest children. Some public health experts are expecting the F.D.A. to authorize both Moderna’s and Pfizer’s vaccines, offering parents a choice between the two. The Centers for Disease Control and Prevention must also weigh in with its recommendations after the F.D.A. acts. Roughly 18 million children younger than 5 are the only Americans who are not yet eligible for shots.
13th Jun 2022 - The New York Times

Japan Has Fewest Covid-19 Deaths Per Capita in OECD, New Data Show

Japan has the lowest number of Covid-19 deaths per capita among wealthy nations, according to new data, with health experts citing the country’s mask habit and low obesity rate as possible reasons. As of Sunday, Japan’s cumulative Covid-19 deaths per million population stood at 245, according to Our World in Data, a website that tallies Covid-19 statistics. That is the lowest figure among the 38 member states in the Organization for Economic Cooperation and Development, a club of wealthy nations that includes the U.S. and most of Europe. The Japanese rate compares with 2,469 Covid-19 deaths per million people in Europe and 3,038 per million in the U.S., which has the highest rate in the OECD. While the reasons for the U.S. rate aren’t well-understood, widespread obesity, less mask-wearing, disparities in access to healthcare and a lower vaccination rate than some other OECD countries likely played a role, public-health specialists have said.
13th Jun 2022 - The Wall Street Journal

Sanofi and GSK share positive data for two COVID-19 booster vaccine trials

In the phase 3 VAT02 cohort 2 trial, the Sanofi/GSK vaccine candidate caused – at day 15 post-immunisation – a significant boost in antibody titres above baseline against multiple variants of concern in adults who previously received mRNA COVID-19 vaccinations. Specifically against Omicron, the preliminary data demonstrated 40 times as much of an increase against the BA.1 variant. In addition to this, the Sanofi/GSK booster produced twice the number of neutralising antibodies against Omicron BA.1 and BA.2 when compared to the original parent virus booster. Thomas Triomphe, executive vice president, Sanofi Vaccines, said: “COVID-19 keeps evolving and the combination of emergence of variants and waning immunity is likely to lead to the need for additional booster shots, at least in some populations. The Beta variant expresses similar mutations across multiple variants of concern, including Omicron, making it a strong vaccine candidate to confer broad protection against multiple strains of COVID-19.
13th Jun 2022 - PMLiVE

Risk of severe COVID-19 in adults with immune-mediated inflammatory diseases and those on immune-modifying therapies

A total of 17,672,065 subjects, of which 1,163,438 subjects (55% females and 45% males, and 71% Whites) had inflammatory disorders, and 16,508,627 subjects (49.8% females and 50.2% males, and 64% of Whites) were included from the general public. Out of 1,163,438 subjects with immunological inflammatory disorders, 1.6% (n=19,119) were administered immunomodulatory therapeutic agents, whereas 15.6% (n=181,694) were administered standard systemic therapies. Compared to the general public, individuals with inflammatory disorders showed a higher risk of SARS-CoV-2 infection-associated mortality after data adjustments for confounding variables (HR 1.2) and mediators (HR = 1.2). In addition, individuals with inflammatory disorders showed a higher risk of SARS-CoV-2 infection-associated admissions in critical care settings or mortality (confounder-adjusted HR and mediator-adjusted HRs were 1.2 and 1.2, respectively) and hospitalization (confounder-adjusted HR 1.3, and mediator-adjusted HR 1.2).
13th Jun 2022 - News-Medical.Net

Pfizer COVID vaccines safe and effective for small children, FDA staff say

U.S. Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech's, COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years. The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children. The FDA analysis of data from Pfizer's trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from the external advisers will determine the FDA's decision on the vaccines.
13th Jun 2022 - Reuters

Sanofi says next-gen COVID booster shot has potential against main variants

French drugmaker Sanofi said on Monday an upgraded version of the COVID-19 vaccine candidate it is developing with GSK showed potential in two trials to protect against the virus's main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot. While the two companies' first experimental COVID shot is undergoing review by the European Medicines Agency, Sanofi and GSK have continued work on a vaccine that is molded on the now-supplanted Beta variant, hoping still that it will confer broad protection against future viral mutations.
13th Jun 2022 - Reuters

Valneva shares plunge as European COVID vaccine deal flounders

Valneva shed around a quarter of its market value on Monday after the French drugmaker warned that the future of its COVID-19 vaccine was in jeopardy. Valneva has been trying to salvage a deal with the European Commission (EC) which has indicated it would terminate an advance purchase agreement for up to 60 million doses. "We do understand that the European Commission is faced with this challenge of having too many vaccine doses on stock," Valneva CEO Thomas Lingelbach told Reuters.
13th Jun 2022 - Reuters

Understanding long Covid will take the lived experiences of long haulers

I went from training for the Big Sur 21-miler to barely being able to climb a flight of stairs in just six months. The cause? Covid-19 or, more specifically, long Covid. As a researcher, I want to know how this happened and, more importantly, how to fix it. I’m not alone. The “fix it” question is on the minds of as many as 23 million Americans and 100 million people worldwide who have experienced long Covid, which has emerged as a new chronic illness. In August 2021, two members of my household tested positive for Covid. Being fully vaccinated, I didn’t test myself but, between the exposure and developing a number of Covid symptoms, saw the writing on the wall.
13th Jun 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Jun 2022

View this newsletter in full

Why your returning sense of smell after COVID may feel strange

The loss or change in one’s sense of smell and taste has proven to be a more accurate indicator of a COVID-19 infection than even a fever and cough. The exact percentage of people who experience a loss or change in their sense of smell after contracting COVID-19 is difficult to estimate as it relies on affected people self-reporting, but one analysis suggests it could be just more than 50 percent.
12th Jun 2022 - Al Jazeera English

Valneva working on remediation plan for COVID-19 vaccine candidate

French drugmaker Valneva said on Friday it had proposed a remediation plan after receiving the European Commission's notice of intent to terminate the advance purchase agreement for its inactivated COVID-19 vaccine candidate. "Some member states have confirmed their interest in having an inactivated, adjuvanted whole-virus vaccine solution in their portfolio," the company said in a statement.
12th Jun 2022 - Reuters

U.S. FDA staff says Moderna COVID vaccine effective and safe for children

U.S. Food and Drug Administration staff reviewers on Friday said Moderna Inc's COVID-19 vaccine appears safe and effective for use in children aged 6 months to 17 years old as a committee of scientists will meet next week to vote on whether to recommend the regulator authorize the vaccine in children. The FDA's reviewers said in briefing documents published on Friday evening that the vaccine had generated a similar immune response in the children than that observed in adults in previous trials.
12th Jun 2022 - Reuters

EU drug regulator: mRNA COVID vaccines do not cause absence of menstruation

Available data suggest that mRNA COVID-19 vaccines do not cause an absence of menstruation, the European Union's health regulator concluded on Friday. The assessment was prompted by reports of menstrual disorders after receiving one or two shots of either the Moderna (MRNA.O) or the Pfizer-BioNTech (PFE.N)(22UAy.DE) vaccines. Menstrual disorders can occur due to a range of reasons, including underlying medical conditions as well as stress and tiredness. Health authorities have highlighted that cases have also been reported following COVID-19 infection.
12th Jun 2022 - Reuters

South Africa's Death Claims Triple Last Year Due to Covid-19

The value of death claims almost tripled and suicides rose 18% last year as South Africa was battered by coronavirus infections, Discovery Life Ltd. said, citing data from its clients. In early 2021, South Africa grappled with the later stages of a beta variant-driven wave of Covid-19 infections. It was hit by the delta variant in mid-year and omicron toward the end of the year. “It was completely unprecedented,” Discovery Life’s Deputy Chief Executive Officer Gareth Friedlander said in an interview on Thursday. “Add all causes of death together -- that’s your cancers, motor-vehicle accidents, heart attacks, strokes -- add them all together and it’s still 50% less than the Covid-death claims.”
10th Jun 2022 - Bloomberg

Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases

An increased risk of myocarditis or pericarditis was observed after COVID-19 mRNA vaccination and was highest in men aged 18–25 years after a second dose of the vaccine. However, the incidence was rare. These results do not indicate a statistically significant risk difference between mRNA-1273 and BNT162b2, but it should not be ruled out that a difference might exist. Our study results, along with the benefit–risk profile, continue to support vaccination using either of the two mRNA vaccines.
10th Jun 2022 - The Lancet

'More work' to be done': Key takeaways from the WHO report on origins of the Covid-19 pandemic

Current data suggests a zoonotic origin of SARS-CoV-2 -- which means the virus originated in animals and jumped to humans. The most closely genetically related viruses were found to be beta coronaviruses identified in bats in China and Laos, according to SAGO. "However, so far neither the virus progenitors nor the natural/intermediate hosts or spill-over event to humans have been identified," the report said. The group pointed to published surveys of animals sold at the Huanan Seafood Market in Wuhan, where the virus was first identified. Between 2017 and 2019, the survey showed that several species known to be susceptible to SARS-CoV-2, such as racoon dogs and red foxes, were present in the market. But those animals were not sampled in the studies presented to the team by invited Chinese scientists. SAGO said further information about studies into the testing of these animals, as well as tracing back to source farms and serologic investigations into people who farmed and sold or traded the animals have been requested.
10th Jun 2022 - CNN

COVID-19: How long-term smell loss can impact daily life

Recent studies show that 12-18 months after getting COVID-19, up to 46% of people are still experiencing a clinical reduction in their sense of smell. But what are the impacts of long-term smell loss on everyday life? Issues can include challenges with food safety, weight, relationships and mental health, according to a neuroscientist. Smell training can improve olfactory functions over time.
10th Jun 2022 - World Economic Forum

Preventing another Covid-19: Ugandan lab leads hunt for zoonotic diseases

On the shores of Lake Edward, near Uganda’s border with the Democratic Republic of Congo (DRC), a renovated building houses a research laboratory capable of handling serious diseases such as anthrax. This building is the newest front in the hunt for zoonotic diseases and is at the forefront of a growing research movement that focuses on east Africa and other infection hotspots. The recent emergence of Covid-19 and monkeypox, both of which jumped from animals to humans, have been a reminder of the power that such diseases have to reshape our world, and the importance of early identification and genomic sequencing to help stop their spread.
10th Jun 2022 - Financial Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Jun 2022

View this newsletter in full

Covid During Pregnancy Doubled Babies' Risk of Delays in Study

Babies whose mothers caught Covid-19 during pregnancy faced nearly double the risk of being diagnosed with delayed speech or motor skills by their first birthday, according to a study of medical records. While the risk of developmental delays was low overall, it rose to about 6% among babies who were exposed to Covid in the womb, while unexposed infants’ risk was about 3%, according to findings released Thursday in the journal JAMA Network Open. The lags were seen in behaviors such as rolling over, reaching for objects or babbling -- basic milestones of infancy.
10th Jun 2022 - Bloomberg

UK Monkeypox Cases Told to Avoid Contact With Household Members

UK residents diagnosed with monkeypox are being told to self-isolate from other people in their household, as the nation ramps up efforts to slow the spread of the disease. The UK Health Security Agency on Thursday advised infected Britons to sleep and eat in different rooms from other household members and to use a separate bathroom if possible. People diagnosed with the disease have also been told to keep their laundry apart and to avoid close contacts with pets.
10th Jun 2022 - Bloomberg

HIV may predispose to post-vaccination COVID, requiring extra doses

The risk of COVID-19 infection after primary vaccination was 28% higher in adults diagnosed as having HIV, suggesting they may benefit from two additional doses, according to a US study published yesterday in JAMA Network Open. Johns Hopkins University researchers led a team assessing the risk of COVID-19 infection among 113,994 vaccinated patients—33,029 of whom had HIV and 80,965 who didn't—through Dec 31, 2021. Participants were part of the Corona-Infectious-Virus Epidemiology Team (CIVET)-II cohort and were seen at Kaiser Permanente Mid-Atlantic States, Kaiser Permanente Northern California, the University of North Carolina Chapel Hill HIV Clinic, and the Veterans Aging Cohort Study (VACS) sites.
9th Jun 2022 - CIDRAP

Nine Omicron symptoms affecting the fully vaccinated - and signs you may have it

Researchers in Norway conducted a study interviewing 111 out of 117 guests to a party on 26 November 2021 where there was an Omicron outbreak. Of the group interviewed, 66 had definitive cases of Covid-19 and 15 had possible cases of the virus. Of the 111 participants, 89 per cent had received two doses of an mRNA vaccine and none had received a booster shot. According to the findings published in the infectious disease and epidemiology journal Eurosurveillance, there were eight key symptoms experienced by the group of fully vaccinated partygoers. These were: a persistent cough, runny nose, fatigue, sore throat, headache, muscle pain, fever and sneezing.
9th Jun 2022 - The Independent

Trials of new Covid vaccine raise hopes of once-a-year booster

The vaccine is the first “bivalent” formulation to combine protection against Omicron and the original strain of coronavirus, and is the company’s leading candidate for upcoming autumn booster programmes. Dr Paul Burton, Moderna’s chief medical officer, said the new vaccine raised antibody levels to such a degree that one booster a year could be enough, unless a substantially different variant calls for the vaccine to be redesigned again. “The data we show today are really important because we get a really strong antibody response against Omicron,” he said. “For the first time, we could really be looking at the potential for just once-yearly boosting, because we can get people to such a high level that they will take longer to decay.” The new vaccine, called mRNA1273.214, combines 25 micrograms of the original Moderna Covid vaccine with 25 micrograms of vaccine specifically targeted at the Omicron variant. In the phase 2/3 trial, the 50mcg shots were given to 437 people who had already received two primary jabs and a booster of the original Moderna vaccine earlier in the pandemic.
9th Jun 2022 - The Guardian

Covid-19 news: Moderna's omicron booster has promising immune response

Moderna’s omicron-tailored booster candidate produces eight times as many virus-neutralising antibodies against the variant as its original booster vaccine An updated version of Moderna’s covid-19 vaccine that targets the BA.1 sublineage of omicron leads to an eight-fold increase in antibody levels against the variant of concern, according to a small, preliminary study. Moderna’s new booster is the first covid-19 vaccine to combine the jab that targeted the original strain of the coronavirus – which emerged in Wuhan, China, at the end of 2019 – with a vaccine that specifically targets the omicron variant. In the clinical trial, the updated vaccine was given to 437 people who had already received two full-dose Moderna vaccines and its booster.
9th Jun 2022 - New Scientist

Japan's Shionogi says continuing Vietnam COVID projects after partner scandals

Japan's Shionogi & Co Ltd said its COVID-19 projects in Vietnam are still progressing, after fraud scandals enveloped its partner there and the health ministry. Shionogi is carrying out trials of its experimental COVID vaccine and oral treatment in Vietnam, following a memorandum of understanding with the government and Advanced International Joint Stock Co in November. Vietnam's health minister Nguyen Thanh Long was arrested on Tuesday, following dismissal from his post on charges of falsely inflated prices for COVID tests.
9th Jun 2022 - Reuters

Moderna says Omicron-targeted COVID shot shows better response

Moderna Inc said on Wednesday a new version of its coronavirus vaccine produced a better immune response against Omicron than the original shot, as the drugmaker pursues a booster against a surge in infections in the fall season. The vaccine, which was given as a fourth dose in a trial that enrolled more than 800 people, raised virus-neutralizing antibodies by eight-fold against Omicron. The company said it plans to submit data on the vaccine, which targets Omicron as well as the original coronavirus strain, to regulators in the coming weeks and the doses could be available to consumers in late summer, sending its shares up 3%.
9th Jun 2022 - Reuters

AstraZeneca trots out Evusheld data to expand the COVID preventive drug into the treatment arena

AstraZeneca is back in the COVID-19 game with new data for its antibody cocktail, Evusheld. While it's existing authorizations cover the prophylactic setting, the latest results from the Big Pharma puts the drug in contention as a treatment for patients with mild-to-moderate disease. The company posted data from a phase 3 trial in the Lancet Respiratory Medicine, showing that the medicine reduced the risk of progression to severe COVID or death from any cause by 50% compared to placebo at day 28, which was the trial's primary endpoint. The drug was tested in non-hospitalized adults with mild-to-moderate COVID-19, and 90% of the patients were at risk of progressing to severe COVID. While the study, dubbed Tackle, included patients who had symptoms for seven days or less, it was designed with a pre-specified analyses to assess patients who received the intramuscular injection within three days of symptom onset. In this group, Evusheld reduced the risk of severe COVID or death from any cause by 88% compared to placebo, and the risk reduction was 67% when participants received Evusheld within five days of symptom onset.
9th Jun 2022 - FiercePharma

WHO: COVID origins unclear but lab leak theory needs study

More than two years after coronavirus emerged in China and after at least 6.3 million deaths have been counted worldwide from the pandemic, the World Health Organization is recommending in its strongest terms yet that a deeper probe is required into whether a lab accident may be to blame. That stance marks a sharp reversal of the U.N. health agency’s initial assessment of the pandemic’s origins, and comes after many critics accused WHO of being too quick to dismiss or underplay a lab-leak theory that put Chinese officials on the defensive. WHO concluded last year that it was “extremely unlikely” COVID-19 might have spilled into humans in the city of Wuhan from a lab. Many scientists suspect the coronavirus jumped into people from bats, possibly via another animal.
9th Jun 2022 - FiercePharma

Pandemic's origins obscured by lack of Chinese data - WHO panel

The World Health Organization said on Thursday its latest investigation into the origins of COVID-19 was inconclusive, largely because data from China is missing, another blow to its years-long effort to determine how the pandemic began.
9th Jun 2022 - Reuters

Diabetes may increase long COVID risk; COVID while pregnant linked to baby brain development issues

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Diabetes may increase long COVID risk. Diabetes may increase the risk of long COVID, new analyses of seven previous studies suggest. Researchers reviewed studies that tracked people for at least four weeks after COVID-19 recovery to see which individuals developed persistent symptoms associated with long COVID such as brain fog, skin conditions, depression, and shortness of breath. In three of the studies, people with diabetes were up to four times more likely to develop long COVID compared to people without diabetes, according to a presentation on Sunday at the annual Scientific Sessions of the American Diabetes Association. The researchers said diabetes appears to be "a potent risk factor" for long COVID but their findings are preliminary because the studies used different methods, definitions of long COVID, and follow-up times, and some looked at hospitalized patients while others focused on people with milder cases of COVID-19.
9th Jun 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Jun 2022

View this newsletter in full

A new coronavirus found in Swedish bank voles

The current study discusses the discovery of a novel beta-CoV in Swedish bank voles and presents its full sequence for the first time. The failure to detect this virus using a published pan-CoV PCR test is traceable to the highly divergent RNA sequence of the Grimso virus. The use of specific spike gene primers in the customized PCR used in the present study yielded several samples over the three-year study period. The two complete sequences obtained in this study showed almost 3.5% non-identity, which amounted to about 1,340 differences at the nucleotide level. This exceeds the expected rate of nucleotide substitution over three years. Either several strains of the Grimso virus are co-circulating in this rodent species, or the true reservoir of this virus includes other species that regularly transmit it to bank voles. The prevalence of the Grimso virus in this rodent species was about 3.4%, thus suggesting that this animal is a suitable host for the virus. As a result, the Grimso virus presents a potential zoonotic host for spillover events between bank voles and human beings.
9th Jun 2022 - News-Medical.Net

Revised Moderna Vaccine Works Better Against Omicron, Trial Suggests

Moderna released preliminary results on Wednesday on an updated coronavirus vaccine that targets the Omicron variant, calling it “our lead candidate” to serve as a U.S. booster shot in the fall. The firm’s researchers tested a booster dose combining the original vaccine with one that specifically targeted Omicron, the variant that became dominant last winter. They found that among those with no evidence of prior coronavirus infection, the combination produced 1.75 times the level of neutralizing antibodies against Omicron as the existing Moderna vaccine did alone. While those results may seem encouraging on their face, many experts worry that the virus is evolving so quickly that it is outpacing the ability to modify vaccines, at least as long as the United States relies on human clinical trials for results.
9th Jun 2022 - The New York Times

FDA AdCom strongly backs EUA of Novavax COVID-19 Vaccine

The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over. The vaccine was developed by US biotech firm Novavax (Nasdaq: NVAX), whose shares leapt 22% to $58.05 in after-hours trading on Tuesday.
8th Jun 2022 - The Pharma Letter

Researchers plan to commence a clinical trial on new COVID-19 inactivated vaccine

A medical research team from the University of Hong Kong (HKU) will start a large-scale clinical trial on a new COVID-19 inactivated vaccine (Omicron variant) developed by China National Biotec Group (Sinopharm). Led by Professor Ivan Hung, Chief of Division of Infectious Diseases and Clinical Professor of Department of Medicine, LKS Faculty of Medicine, The University of Hong Kong (HKUMed) and with the coordination and technical support by HKU Clinical Trials Centre (HKU-CTC), the study aims to evaluate the investigational vaccine's safety and immune response as a booster for adults and will last for around a year. 1,800 adult volunteers who have already received two or three doses of inactivated or mRNA COVID-19 vaccines will be recruited to take part in the study.
8th Jun 2022 - News-Medical.Net

Pfizer Covid Vaccine Protects Against Omicron Sublineages BA.4 and BA.5: Study

Pfizer Inc. and BioNTech’s Covid-19 vaccine appears to largely prevent severe disease from the coronavirus omicron variants sublineages BA.4 and BA.5, a study by South Africa’s biggest health insurer shows. The two-shot Pfizer course offers 87% protection against being hospitalized with the strains that are driving the country’s fifth wave of infections, Discovery Health Ltd., basing its study on the the more than 1 million clients it has in Gauteng province. That level of protection was based on infection in patients one to two months after receiving their second dose. The study showed that protection waned to 84% three to four months after the second dose and 63% at five to six months post inoculation, Ryan Noach, the company’s chief executive officer, said in a LinkedIn post dated June 6.
8th Jun 2022 - Bloomberg

FDA advisers support Novavax's Covid-19 vaccine for authorization

Vaccine advisers to the US Food and Drug Administration decided Tuesday that authorizing Novavax's Covid-19 vaccine -- which uses different technology from the three vaccines currently in use in the US -- for emergency use in adults would be beneficial. Most of the FDA's Vaccines and Related Biological Products Advisory Committee voted "yes" in response to a question of whether the benefits of Novavax's vaccine, given as a two-dose primary series, outweigh its risks in people 18 and older, based on available evidence. Twenty-one members voted yes, one abstained, and none voted no. If the full FDA gives the vaccine the green light, it will become the fourth Covid-19 vaccine authorized in the United States. Novavax's vaccine is made using small laboratory-built pieces of the coronavirus to stimulate immunity. This protein-based approach is a more traditional one for vaccine development than the mRNA vaccines from Pfizer/BioNTech and Moderna.
8th Jun 2022 - CNN

Moderna Says Bivalent COVID-19 Booster Shows Superior Antibody Response Against Omicron

Biotechnology company Moderna Inc. said Wednesday that its omicron-containing bivalent booster candidate mRNA-1273.214, which contained mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern, demonstrated superior antibody response against omicron. According to the company, mRNA-1273.214 met all primary endpoints in the phase 2/3 trial including neutralizing antibody response against Omicron when compared to a 50 micrograms booster dose of mRNA-1273 in baseline seronegative participants. The study results showed mRNA-1273.214 exhibited an eight-fold boost in neutralizing geometric mean titers against omicron among baseline seronegative participant
8th Jun 2022 - Business Insider

Hospital studying long-term effects of COVID-19 in kids

Adriana Vaughan tested positive for COVID-19 in October 2021. Eight months later, the 12-year-old has a string of new medical issues: fatigue, headaches, stomach problems and more. Vaughan can't even walk for six minutes without losing her breath. She says swimming, which she did before getting COVID, is also hard. "I do really love the water and swimming. I tried to do it a few days ago, it was really a lot for me," Vaughan told CBS News.
8th Jun 2022 - CBS News

Can I Trust My Rapid Covid-19 Test if It Says I’m Negative?

When my 14-year-old son had a sore throat and congestion recently, I whipped out a Covid-19 rapid antigen test. Negative. The next day I tested him again. Negative. Days later when his friend tested positive for Covid-19 and my son still had cold symptoms, we tested again. Negative again. Could I safely assume he was Covid-19 free? It’s a question many people are asking now as Omicron subvariants circulate alongside colds, allergies and other viruses. With Americans largely returning to prepandemic habits, and precautions such as mask mandates dropped, many people have come to rely on rapid testing to avoid spreading the virus. But with so many people having symptoms and still testing negative, it’s hard to know whether to trust the results. A positive test has ramifications well beyond validating symptoms, potentially keeping you out of work or your children out of school.
8th Jun 2022 - The Wall Street Journal

Study: Many children who contracted COVID-19 did not develop antibodies to ward off Omicron

A new study from researchers at Harvard Medical School, Boston Children’s Hospital, and the U.S. Food and Drug Administration shows that fewer than 10 percent of kids who contracted COVID-19 in 2020 or early 2021 developed antibodies capable of warding off the Omicron variant of the virus, according to a statement posted to the medical school’s website. The statement said the study findings, published May 27 in the journal Nature Communications, track with prior studies of adults that showed getting COVID-19 once sadly doesn’t guarantee antibody protection against repeat infection at a later date. “I hear parents say, ‘oh, my kid had COVID last year,’” said Dr. Adrienne G. Randolph, a co-senior investigator on the HMS/Children’s study and HMS professor of anesthesia and of pediatrics at Boston Children’s, in the statement. “But we found that antibodies children produced during prior infections don’t neutralize Omicron.
8th Jun 2022 - Boston.com

Moderna says updated Covid-19 vaccine booster shows stronger antibody response against Omicron

Moderna said on Wednesday its bivalent Covid-19 vaccine booster that contained a vaccine targeting the Omicron variant showed a stronger immune response against the variant.
8th Jun 2022 - CNN on MSN.com

Catalent, MigVax enter deal to develop tablet vaccine for Covid-19

Catalent and Israeli biopharmaceutical firm MigVax have entered a development agreement to use the former’s Zydis Bio orally disintegrating tablet (ODT) technology for delivering the Covid-19 vaccine, MigVax-101. A lead oral vaccine programme of MigVax, MigVax-101 is an orally disintegrating freeze-dried tablet vaccine against Covid-19. It demonstrated positive data in preclinical tests. The oral formulation of the vaccine could provide substantial potential benefits in low-and middle-income nations over the existing first-generation injected vaccines. These benefits include ease of dosing, storage and transportation, the potential to address variants in the future and applicability to a wider population.
8th Jun 2022 - Pharmaceutical Technology

Novavax COVID shot, aimed at vaccine skeptics, overwhelmingly backed by FDA panel

Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the agency authorize Novavax Inc's (NVAX.O) COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics. The panel of outside vaccine experts voted 21-0 with one abstention in favor of the vaccine for those 18 and older after discussing whether the shot's benefits outweigh risks, including rare occurrences of heart inflammation that may be associated with the vaccine.
8th Jun 2022 - Reuters

Moderna says Omicron-targeted COVID shot shows better response

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Jun 2022

View this newsletter in full

How to Compare COVID Deaths for Vaccinated and Unvaccinated People

Looking at COVID data in recent months, it may appear that a significant proportion of the people who have died of COVID were vaccinated against the disease. But it is important to put those numbers in context. The U.S. Centers for Disease Control and Prevention has compiled data from 28 geographically representative state and local health departments that keep track of COVID death rates among people age 12 and older in relation to their vaccination status, including whether or not they got a booster dose, and age group. Each week in March, on average, a reported 644 people in this data set died of COVID. Of them, 261 were vaccinated with either just a primary round of shots—two doses of an mRNA vaccine or a single dose of Johnson & Johnson’s vaccine—or with that primary series and at least one shot of a booster.
7th Jun 2022 - Scientific American

FDA advisers meeting on Novavax, a latecomer in COVID-19 vaccine race

A federal advisory committee Tuesday will vote on whether regulators should authorize a COVID-19 vaccine made by Novavax, an early beneficiary of the government’s Operation Warp Speed program. The experts to the Food and Drug Administration will base their recommendation on the company’s clinical trial data, which is strong. But before the agency could authorize the shots, the FDA would also need to sign off on Novavax’s manufacturing process, which has stumbled repeatedly over the course of two years. If the FDA authorizes the Novavax two-dose vaccine, it would become the fourth shot to win clearance for adults in the United States. But even if the company does get the green light, it is unclear when or how widely the vaccine might be available. Shots from Pfizer, Moderna and Johnson & Johnson have been authorized for well over a year, and the country is not short of doses. And in a number of countries where Novavax has already earned authorization, uptake has been low.
7th Jun 2022 - Chicago Tribune

Study: Ineffective blood oxygen readers have endangered Black and Latino Covid-19 patients

Black and Latino patients experienced significant delays in obtaining life-saving Covid-19 treatments due to a popular medical device that inaccurately reads darker skin tones, according to a study released last week in JAMA Internal Medicine. The report shows that pulse oximeters, a device that clips onto a person’s fingertips and reads oxygen levels, is more likely to produce inaccurate results in Black, Latino and Asian Americans than in white patients. The device can make patients of color appear healthier than they actually are, researchers said. “Not only less accurate, but in particular, more optimistic,” Tianshi David Wu, a co-lead author of the study and assistant professor of pulmonary medicine at Baylor College of Medicine in Texas, told NBC News. “In this study we found that minority patients appeared healthier than they really were based on this bias in pulse oximetry.”
7th Jun 2022 - NBC News

Influenza vaccination rates of health and aged care facility staff during the COVID-19 pandemic

In a recent study published in the Medical Journal of Australia, researchers assessed the impact of coronavirus disease 2019 (COVID-19) on influenza vaccination. The target rate for the influenza vaccine uptake to be received by healthcare workers was 75% in 2014, which increased to 92% in 2021. Moreover, staff of the residential aged care services (RACS) were compulsorily required to be vaccinated against influenza from May 2020 throughout Australi
7th Jun 2022 - News-Medical.Net

Imatinib yields sustained clinical benefit in patients with hypoxemic COVID-19

Treatment with imatinib resulted in a sustained clinical benefit after 90 days in hospitalized patients with hypoxemic COVID-19, according to results of the CounterCOVID study. At the American Thoracic Society International Conference, Job R. Schippers, MD-PhD candidate for pulmonary medicine at Amsterdam University Medical Center, presented long-term clinical outcomes at 90 days after treatment with imatinib.
7th Jun 2022 - Healio

U.S. FDA expert panel weighs Novavax COVID vaccine

Advisers to the U.S. Food and Drug Administration on Tuesday will vote on whether to recommend authorizing Novavax Inc's COVID-19 vaccine, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics. The shot being considered by the FDA panel of outside experts is a more traditional type of vaccine employing technology that has been used for decades to combat diseases including Hepatitis B and influenza.
7th Jun 2022 - Reuters

J&J gives notice to terminate Emergent manufacturing deal for COVID vaccine

Johnson & Johnson said on Monday it had formally informed Emergent BioSolutions Inc of its decision to terminate agreement with the contract manufacturer to make COVID-19 vaccine for the drugmaker. The termination notice comes about a week after J&J had initially informed Emergent of its intent to end the pact based on the contract manufacturer's breaches, including failure to supply COVID-19 vaccine drug substance, J&J said.
7th Jun 2022 - Reuters

Experts predict increase in Covid hospital admissions and another wave

A new Covid wave could be looming in England, experts say, as Covid hospital admissions stop falling. Admissions of people to hospital with Covid in England have stopped declining, according to an analysis of new NHS figures by John Roberts a leading actuary from the Covid actuaries group. When asked if the UK was heading into another wave Mr Roberts, told The Independent said “yes we could be but...how big that wave and how serious it will be in terms of admissions and deaths is very, very difficult to judge at this stage.” His comments come after experts in Europe warned there will be a new wave driven by growth of the BA.5 and BA. Covid variants.
7th Jun 2022 - The Independent

Novavax COVID shot, aimed at vaccine skeptics, overwhelmingly backed by FDA panel

Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the agency authorize Novavax Inc's COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics. The panel of outside vaccine experts voted 21-0 with one abstention in favor of the vaccine for those 18 and older after discussing whether the shot's benefits outweigh risks, including rare occurrences of heart inflammation that may be associated with the vaccine.
7th Jun 2022 - Reuters

U.S. CDC removes mask recommendation from monkeypox travel notice to avoid confusion

The U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday it had removed a mask recommendation from its monkeypox travel notice to avoid "confusion" over the disease, which primarily spreads through direct contact. "Late yesterday, CDC removed the mask recommendation from the monkeypox Travel Health Notice because it caused confusion," a CDC spokesperson said on Tuesday. The agency had earlier suggested that travellers wear masks as it can help protect against "many diseases, including monkeypox"
7th Jun 2022 - Reuters

FDA advisers back Novavax COVID shots as 4th US option

American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot. Next, the FDA must decide whether to authorize the protein vaccine made by latecomer Novavax as the nation’s fourth coronavirus shot for adults. It’s made with more conventional technology than today’s dominant Pfizer and Moderna shots and the lesser-used Johnson & Johnson option. N ovavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, either for initial vaccinations or as mix-and-match boosters. But U.S. clearance is a key hurdle for the Maryland-based company. FDA’s vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts -- whatever their reason -- to consider rolling up their sleeves.
7th Jun 2022 - The Associated Press

Novavax coronavirus vaccine would be fourth authorized in United States

More than a year after people began rolling up their sleeves for cutting-edge coronavirus shots, a new vaccine, this one based on a classic decades-old technology, is expected to begin rolling out in the United States this summer. Advisers to the Food and Drug Administration are scheduled to debate Tuesday whether a shot developed by the Maryland biotechnology company Novavax, an underdog in the vaccine race, is safe and effective. If the shot gets the green light, it will become the fourth coronavirus vaccine in the nation. For most people, some already on their third or fourth messenger RNA coronavirus shot from Moderna or Pfizer-BioNTech, it looks like a puzzle: A new vaccine? Why bother? But for a small contingent of holdouts who have closely tracked the progress of the Novavax vaccine, this is a moment of truth.
5th Jun 2022 - The Washington Post

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Jun 2022

View this newsletter in full

N.S. researchers receive nearly $1.5M to study impacts of COVID-19

Three teams of researchers from Nova Scotia have received almost $500,00 each from the Canadian Institutes of Health Research to examine how the pandemic is affecting the lives of children with complex needs, woman who face violence and equity-deserving groups. The studies are among 965 research projects related to the COVID-19 pandemic funded by the national funding organization to date. They are designed to offer recommendations on how to better serve those specific groups when public health safeguards are imposed.
6th Jun 2022 - CBC.ca on MSN.com

I am an epidemiologist with COVID-19 and I want to be counted

I am an epidemiologist who is home sick with COVID-19. Upon a positive self-test, I contacted my primary care physician to ask about treatment and report my case. As my symptoms worsened and more of my family members tested positive on a self-test, I turned to the Centers for Disease Control and Prevention (CDC) to find out how to report our cases. CDC guidance suggests that I tell my health care provider that I have tested positive, but the health care system has no means of reporting self-tests for COVID-19 surveillance. I cannot report the cases of COVID-19 in my family and we, like so many Americans suffering during this current wave, will go uncounted.
6th Jun 2022 - The Hill on MSN.com

Strong T-cell response for blood cancer patients after vaccine; COVID breakthrough often serious for cancer patients

The following is a summary of some recent studies on COVID-19 and cancer presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Blood cancer patients show strong T-cell response to COVID vaccines. Patients with blood cancers have a significantly weaker antibody response to COVID-19 vaccines than patients with solid tumors, but they may still be well protected against severe illness from the virus, new data suggests.
6th Jun 2022 - Reuters

Pfizer to Invest $120 Million to Produce COVID-19 Oral Treatment in the US

Pfizer Inc.announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, PAXLOVIDTM (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). The investment will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which will create more than 250 additional high-skilled jobs at Pfizer’s Kalamazoo site. This investment is another major step in Pfizer’s effort to bring more key biopharmaceutical manufacturing to the U.S., increasing Pfizer’s capability to produce and supply treatments and medicines for patients in the U.S. and around the world.
6th Jun 2022 - Pfizer

FDA to rule on long-awaited 'protein based' COVID-19 vaccine this week

The FDA's lead vaccine advisory panel, VRBPAC, will meet this week to discuss approval for the Novavax COVID-19 vaccine. Novavax's shot has been heralded by some experts for its effectiveness and because it is a protein-based shot similar to the standard flu shot. The jab was expected to become available last year, but supply issues faced by Novavax delayed its application. The review comes as an NBC report finds that more than 10% of the nation's purchased vaccines since they first became available in late 2020 have been discarded
6th Jun 2022 - Daily Mail

Ofatumumab for Multiple Sclerosis Does Not Increase COVID-19 Severity

No increased risk for breakthrough COVID-19 infection, severe COVID-19, or fatal outcomes among patients receiving ofatumumab for relapsing multiple sclerosis (MS) was found in an updated analysis presented at the 2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) held from June 1-4, in National Harbor, Maryland. SARS-CoV-2 is associated with a severe respiratory infection which can be fatal. Since the beginning of the pandemic, there has been concern and uncertainty about specific risks for patients receiving disease-modifying therapy (DMT).
6th Jun 2022 - Neurology Advisor

Safety and efficacy of SCB-2019 COVID vaccine candidate as a ChAdOx1-S booster

The standard formulation containing 30 μg SCB-2019 with the toll-like receptor 9 (TLR-9) agonist CpG-1018 and alum showed the best booster response. This formulation demonstrated acceptable reactogenicity, comparable to that observed in the SPECTRA study. Moreover, it was safe and highly efficacious as a heterologous booster following primary vaccination.
6th Jun 2022 - News-Medical.Net

Why Variants Keep Covid-19 Cases Simmering in the U.S.

In recent weeks, a new version of the Covid-19 virus—named BA.2.12.1—became the dominant variety in the U.S., according to the Centers for Disease Control and Prevention. The variant’s rapid spread, coupled with growing case counts, raised concern among health officials, who last month strengthened their recommendations for Covid-19 boosters.
6th Jun 2022 - The Wall Street Journal

Long-term exposure to air pollution associated with greater risk of severe COVID-19

Long-term exposure to air pollution is linked to a greater risk of severe COVID-19, new research being presented at Euroanaesthesia, the annual meeting of the European Society of Anaesthesiology and Intensive Care (ESAIC) in Milan, Italy (4-6 June), finds. The German study found that people living in counties with higher levels of the pollutant nitrogen dioxide (NO2) were more likely to need ICU care and mechanical ventilation if they had COVID-19. Long-term exposure to NO2, a gas released into the atmosphere when fossil fuels are burned, can have harmful effects on the lungs. This includes damage to the endothelial cells, which play a key role in oxygen transfer – the transfer of oxygen from inhaled air to the blood.
6th Jun 2022 - News-Medical.Net

Contract manufacturer Emergent says J&J breached vaccine contract

Contract manufacturer Emergent BioSolutions Inc said on Monday U.S. drugmaker Johnson & Johnson had breached an agreement by failing to buy the minimum quantity of COVID-19 vaccines made by the company. Emergent said J&J had failed to provide required forecasts for the amount of vaccines it needed and had wound down the agreement instead of fulfilling minimum requirements. If the agreement is terminated, Emergent said J&J would owe it roughly $125 million to $420 million.
6th Jun 2022 - Reuters

U.S. FDA flags risk of heart inflammation after Novavax COVID vaccine

The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease. In Novavax's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot. "These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines," FDA staff wrote in briefing documents released on Friday.
6th Jun 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Jun 2022

View this newsletter in full

India approves Biological E. COVID shot as a booster

India has approved Hyderabad-based drugmaker Biological E's COVID-19 vaccine as the first mix-and-match booster dose in the country, the company said on Saturday. The Drugs Controller General of India (DCGI) gave the nod for the Corbevax vaccine to be administerd as a booster shot to people age 18 years and over who have already received two doses of either AstraZeneca Plc's Covishield or Bharat Biotech's Covaxin.
5th Jun 2022 - Reuters

Even a Diehard Covid Test Advocate Says China Is Going Too Far

Michael Mina has long pushed for widespread testing as a way to stop Covid-19 outbreaks in their tracks. But what China is doing, he says, is going too far. Wedded to a pandemic strategy that still seeks to eliminate every coronavirus case, the world’s most populous country is rolling out a vast network of testing booths in urban areas so that millions of people are within a 15-minute walk of getting swabbed at all times. Cities like Beijing, Shanghai, Shenzhen and Hangzhou are requiring tests as often as every 48 hours to access public transit, entertainment venues -- and even workplaces.
4th Jun 2022 - Bloomberg

Novavax hopes its COVID shot wins over FDA, vaccine holdouts

Americans may soon get a new COVID-19 vaccine option -- shots made with a more tried-and-true technology than today’s versions. The big question: Why should they care? After long delays, the Food and Drug Administration is expected to decide within weeks whether to authorize Novavax's vaccine. It’s late in the pandemic for a new choice, with about three-quarters of U.S. adults already vaccinated. But the company is hoping to find a niche among some of the unvaccinated millions who might agree to a more traditional kind of shot -- a protein vaccine — and also to become a top choice for boosters, regardless of which type people got first. Only about half of vaccinated adults have gotten a booster.
3rd Jun 2022 - Yahoo News UK

Developing world should reap benefits of new monkeypox research, experts urge

As cases of monkeypox in wealthier Western nations spark a flurry of scientific research to combat the outbreak, scientists are urging the world to make sure lower-income nations benefit from the fruits of that labor as well. More than 550 confirmed cases of monkeypox have been reported by at least 30 countries outside of Africa, where the virus is typically found, according to the World Health Organization (WHO).
3rd Jun 2022 - Reuters

Vaccination during pregnancy cuts infant infections; vaccines only modestly reduce long COVID risk

Article reports that the following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Vaccines in pregnancy reduce infants' COVID-19 risk COVID-19 vaccination during pregnancy appears to lower newborns' risk of coronavirus infection, according to a study conducted in Norway.
3rd Jun 2022 - Reuters

U.S. FDA flags risk of heart inflammation after Novavax COVID vaccine

The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's (NVAX.O)COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease. In Novavax's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation calledmyocarditis detected within 20 days of taking the protein-based shot. "These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines," FDA staff wrote in briefing documents released on Friday.
3rd Jun 2022 - Reuters

Novavax Plunges on 'Harsh' FDA Review Ahead of Tuesday Panel

Novavax Inc. slumped 20% on Friday after US regulators raised concerns over the biotech’s much-anticipated Covid-19 vaccine. Briefing documents released by the Food and Drug Administration ahead of a meeting with experts on Tuesday noted some heart risks with the shot, though the agency was positive on its effectiveness against the omicron variant and more severe disease.
3rd Jun 2022 - Bloomberg

Japan study shows women more likely to get skin rash from Moderna shot

A study in Japan found that women were significantly more likely than men to develop rash-like side effects after a first dose of Moderna Inc's COVID-19 vaccine. The study of 5,893 participants between May and November last year showed that 22.4% of women developed delayed skin reactions after the first shot, compared to 5.1% of men. The symptoms were mild and not considered a contraindication of the mRNA-based vaccine, according to the June 1 report in JAMA Dermatology.
2nd Jun 2022 - Reuters

Health agency confirms community spread of monkeypox in England

Monkeypox appears to be spreading from person to person in England, the UK Health Security Agency (UKHSA) said on Wednesday. The usually mild viral disease, which is endemic in west and central Africa, is understood to spread through close contact. Until early May, cases rarely cropped up outside Africa and were typically linked to travel to there. "The current outbreak is the first time that the virus has been passed from person to person in England where travel links to an endemic country have not been identified," the agency said.
2nd Jun 2022 - Reuters

Moderna delays COVID vaccine deliveries to EU by several months

Moderna Inc said on Thursday it has agreed to push back some COVID-19 vaccine deliveries to the European Union by several months to later in 2022 or early next year. Shares of Moderna fell nearly 2% before the bell over the delay, even though the company stuck to its vaccine sales forecast of $21 billion for 2022. Delivery of the doses were originally planned in the second quarter, the European Commission said in a statement.
2nd Jun 2022 - Reuters

Pfizer's Paxlovid reduces COVID risk in seniors regardless of vaccine status -study

Pfizer Inc's antiviral treatment Paxlovid reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, according to a new study in Israel conducted during the rise of the Omicron variant of the coronavirus. The treatment, however, was not found to prevent severe illness among younger adults, according to research from Clalit Health Services, Israel's largest healthcare provider.
2nd Jun 2022 - Reuters

COVID-19: Two million people in UK estimated to be suffering from long COVID, Office for National Statistics says

A record two million people in the UK are estimated to be suffering from long COVID, the Office for National Statistics has said. Of the two million, 1.4 million said they first had coronavirus, or suspected they had the illness, at least 12 weeks previously, while 826,000 first had it at least a year earlier. Another 376,000 said they first had COVID-19 at least two years previously. The condition is estimated to be adversely affecting the day-to-day activities of 1.4 million people - around seven in 10 of those who reported having it.
1st Jun 2022 - Sky News

Pfizer Submits Covid Shot for Kids Under 5 for FDA Authorization

Pfizer Inc. asked U.S. regulators to clear its Covid-19 vaccine for emergency use in children under age 5, an effort to extend protection against the virus to the country’s youngest. The drugmaker and BioNTech SE finalized their rolling application to the Food and Drug Administration for emergency-use authorization of their vaccine in kids ages 6 months through 4 years old, the companies said in a statement on Wednesday. The vaccine partners began the submission process in February. Pfizer and BioNTech announced in late May that a three-shot regimen was highly effective and prompted a strong immune response in children under age 5, based on early results from a highly anticipated trial that is likely to pave the way for infants and toddlers to get immunized.
1st Jun 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Jun 2022

View this newsletter in full

Evidence on COVID-19 vaccine effectiveness and duration of protection against Omicron

In the present study, researchers reported results from an interim analysis of a living systematic review (LSR) summarizing evidence on VE and duration of protection against SARS-CoV-2 Omicron. For the LSR, the researchers included studies investigating VE against SARS-CoV-2 infection among people aged 12 years or older for European Medicine Agency (EMA) approved vaccines. For the current analysis, only the studies which investigated the mentioned outcomes due to SARS-CoV-2 Omicron or during the Omicron period were considered. The coronavirus disease 2019 (COVID-19) literature database created by the Robert Koch Institute (RKI) library was searched for studies published from October 23, 2021, to January 14, 2022, regardless of publication status or language.
31st May 2022 - News-Medical.Net

Philippine FDA grants approval for Spikevax Covid-19 vaccine for children

The Philippine FDA has granted approval for Moderna’s Covid-19 vaccine, Spikevax, for use in children who are aged six to 11 years.
31st May 2022 - Pharmaceutical Technology

Study shows low social cohesion is a factor in reducing vaccine responses

Loneliness and social stresses can have a negative impact on the antibody response to Covid-19 vaccines, new research has revealed. University of Limerick researchers have found that lower neighbourhood cohesion is associated with antibody response to Covid-19 vaccines. In a study published in the journal Brain, Behaviour and Immunity, the research team demonstrated that lower social cohesion also made people feel lonelier, and this was an additional factor in reducing Covid-19 vaccine responses. The report stated that social cohesion is the degree of social connectedness and solidarity among different community groups within a society, including levels of trust and connectedness between individuals and across community groups.
31st May 2022 - Belfast Telegraph

International study reveals factors contributing to COVID-19 vaccine hesitancy among healthcare providers

A new 23-country study by a multidisciplinary team of researchers in the journal Vaccine, published by Elsevier, sheds light on the factors that contribute to COVID-19 vaccine hesitancy among healthcare providers. To assess the associations between self-reported vaccine hesitancy and a number of sociodemographic and COVID-19 vaccine perception factors, CUNY Graduate School of Public Health and Health Policy (CUNY SPH) Senior Scholar Jeffrey Lazarus, PhD, Dean Ayman El-Mohandes, MBBCh, MD, MPH, FAAP, and colleagues from the School of Health Administration at Dalhousie University, Halifax, Canada and the Barcelona Institute for Global Health, Barcelona, Spain, developed a cross-sectional survey relating to perceptions of risk, efficacy, safety and trust, and current COVID-19 vaccine uptake.
31st May 2022 - EurekAlert!

GSK offers £2.6bn for US vaccine maker after failing to bring Covid jab to market

GSK has offered to pay up to $3.3bn (£2.6bn) for a US vaccine maker, after the pandemic pushed the importance of biotechnology to the top of the healthcare agenda. The British pharmaceutical giant is set to pay $2.1bn (£1.6bn) upfront, and up to $1.2bn (£951m) more if the biopharmaceutical firm Affinivax meets specified development milestones, GSK said in a statement this morning. Affinivax, based in Boston, focuses on vaccines which target pneumococcal disease, which includes pneumonia, meningitis, bloodstream infections and milder diseases such as sinusitis.
31st May 2022 - City A.M.

Leicester study finds promising link between treatment of 'long Covid' and vaccinations

Symptoms of 'long Covid' can decrease after being vaccinated, a Leicester study has found. The research conducted by the University of Leicester was published in the British Medical Journal. It found that a first dose of the Covid-19 vaccination was associated with a reduction in the likelihood of continuing symptoms of the virus by 12.8 per cent. A second dose showed a further reduction of 8.8 per cent, according to the study. Between February 3 and September 5, 2021, a team of academics and government statisticians assessed the results of the Office for National Statistics’ COVID-19 Infection Survey to examine the health outcomes of 28,356 people who had received a vaccine after contracting the coronavirus. More than 23 per cent of the participants went on to experience symptoms of long Covid 12 weeks after they were infected with the virus.
31st May 2022 - Leicestershire Live

Japan Panel OKs J&J Coronavirus Vaccine

A panel of Japan's health ministry Monday endorsed a ministry plan to give pharmaceutical approval to U.S. drugmaker Johnson & Johnson's COVID-19 vaccine. The ministry is expected to grant the approval soon to what will be the fifth COVID-19 vaccine that can be used in the country. The ministry does not plan to make inoculations of the vaccine free of charge at public expense because it has already secured necessary amounts of vaccines. Japan has not signed to buy the J&J vaccine. The J&J product is a viral vector vaccine like the one made by British drugmaker AstraZeneca PLC. It can be administered only to people aged 18 or above. Only a single shot is necessary for the J&J vaccine unlike the previously approved vaccines, all of which require two shots at an interval of at least three to four weeks.
31st May 2022 - Nippon.com

Study struggles to explain why Quebec has high COVID-19 death toll but low excess death

Researchers are having a hard time explaining why Quebec had the country's highest official COVID-19 death toll despite a relatively low number of excess deaths between March 2020 and October 2021. A new study released Monday by the Canadian Medical Association Journal tried to answer that question but came up short. "I would say at this point it's something we need to understand,'' Kimberlyn McGrail, professor at University of British Columbia's school of population and public health, said in an interview. The study, titled Excess mortality, COVID-19 and health-care systems in Canada, says Quebec had 4,033 excess deaths between March 2020 and October 2021, but reported 11,470 COVID-19 fatalities — almost three times more.
31st May 2022 - CBC.ca

How nasal COVID-19 vaccines can help prepare for infection where it starts

Imagine inhaling just a few drops of liquid or mist to get protected from COVID-19. That is the idea behind nasal COVID-19 vaccines, and they have been getting a lot of attention recently as a spray or liquid. These nasal vaccines would be based on the same technology as normal vaccines given by injection. But as Mayuresh Abhyankar, a University of Virginia researcher who studies infectious diseases and works on nasal vaccines, explains, vaccinating someone right where the coronavirus is likely to start its attack comes with many immunological benefits.
31st May 2022 - PBS NewsHour

Long term implications of covid-19 in pregnancy

Complications in pregnancy, including maternal and perinatal deaths, increased with each wave of the covid-19 pandemic. By contrast, serious illness fell in other high risk groups because of vaccines and approved treatments. More than a year after the UK’s Joint Committee on Vaccination and Immunisation (JVCI) opened up covid-19 vaccination to pregnant women, 40% of women giving birth have still not received a first dose.2 This is despite a positive benefit-risk profile, endorsement in guidelines, and public health campaigns. Worryingly, 69.5% of black women giving birth have not received any covid-19 vaccine. Meanwhile the JCVI has chosen not to include pregnant women in its interim autumn booster plans. Strategies for treating covid-19 in pregnancy and potential long term complications are also underused.1 A large portion of the diffidence for both vaccination and treatment in pregnancy stems from the continued exclusion of pregnant women from much of the pre-approval drug development process. This results in delayed or even absent data on benefit-risk profiles and a dangerous spiral of indecision
31st May 2022 - The BMJ

Swissmedic weighing new COVID booster recommendation for children

Swiss drugs regulator Swissmedic said on Tuesday it is reviewing an application from pharmaceutical company Pfizer for a new dosage recommendation for a COVID-19 booster shot for children. The regulator said it was looking at the data submitted and assessing the benefits and risks of recommending a booster shot administered at least six months after basic immunisation for children between ages 5 and 11.
31st May 2022 - Reuters

Covid Booster Shots Are Key to Stopping Severe Infection: Study

A third dose of messenger RNA Covid-19 vaccine provides a key boost to immunity against the coronavirus, regardless of the original type of immunization, researchers said. An mRNA booster following an initial course of two shots of the same type is the most effective way to prevent non-severe Covid infections, according to an analysis of studies published Wednesday in the BMJ medical journal. Adding a third mRNA shot to other primary vaccination regimens raises protection to almost the same level, the authors from the Chinese University of Hong Kong said.
31st May 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 31st May 2022

View this newsletter in full

Nasal COVID-19 vaccines help the body prepare for infection right where it starts—in your nose and throat

Online education and the mental health of faculty during the COVID-19 pandemic in Japan | Scientific Reports

While the negative impact of the pandemic on students’ mental health has been studied around the world, very little is known about the mental health of faculty and staff. This research aims to examine mental health among Japanese faculty members who taught online courses during the COVID-19 pandemic. We recruited 537 university faculty members and assessed their mental health using the World Health Organization-Five Well-Being Index (WHO-5), both retrospectively (during the academic year before the onset of the pandemic) and during the pandemic.
30th May 2022 - Nature.com

CT chest scans reveal fewer cases of pneumonia in breakthrough COVID-19 infections

CT chest scans in patients with breakthrough COVID-19 infections show lower levels of pneumonia compared to scans of unvaccinated patients. A significantly higher proportion of CT chest scans in fully vaccinated patients who experience a breakthrough infection showed no signs of pneumonia during their stay in hospital, according to a study by Korean researchers. COVID-19 vaccination across the globe has led to a protection against both symptomatic and asymptomatic COVID-19 as well as severe disease, hospitalisation and death. Although a CT chest scan has been described as an indispensable diagnostic tool in COVID-19, no studies have reported on using this imaging modality to examine the features associated with breakthrough infections that are generally less severe.
30th May 2022 - Hospital Healthcare Europe

Fourth COVID-19 vaccination effectiveness drops after 10 weeksHospital Healthcare Europe

A fourth COVID-19 vaccination’s effectiveness against infection drops after only 10 weeks but remains high against severe disease. A fourth COVID-19 vaccination dose offers greater protection against infection than three doses but this effectiveness quickly wanes within 10 weeks but is maintained against more severe disease. This was the key finding of a retrospective analysis by Israeli researchers. The use of a third COVID-19 vaccination is more effective at protecting individuals against severe COVID-19-related outcomes in comparison to only two doses. Nevertheless, it is also becoming clear that in the presence of COVID-19 variants such as Omicron, the relative protection against infection even from three doses wanes over time. For instance, in one study, the effectiveness of a third COVID-19 vaccine, waned from 53.4% a month after vaccination to 16.5% three months later.
30th May 2022 - Hospital Healthcare Europe

Increase in depression and anxiety rates in the U.K. identified during COVID-19 lockdowns

Though many studies have been conducted over the last two years, both during and after coronavirus disease 2019 (COVID-19) restrictions were implemented, the long-term effects of these events remain unclear. A new study published on the preprint server medRxiv* discusses changes in the prevalence of depressive and anxiety symptoms over the course of the COVID-19 pandemic and their association with individual and environmental factors.
30th May 2022 - News-Medical.Net

Launch of Scenario Hub projecting future COVID-19 health impact

A new online modelling hub launched today, the European COVID-19 Scenario Hub, will present modelling projections on how the COVID-19 pandemic may evolve in terms of cases, hospitalisations and deaths. It will serve as a resource for Member States in their pandemic planning and inform decisions aimed at minimising the expected burden caused by COVID-19 under different scenarios. The hub is developed and run by the European Centre for Disease Prevention and Control (ECDC) in co-operation with the Centre for Mathematical Modelling of Infectious Diseases (CMMID) at the London School of Hygiene & Tropical Medicine (LSHTM). “The Scenario Hub will help inform public health preparedness and anticipatory action as Europe transitions into new phases of the pandemic” said Andrea Ammon, ECDC Director. “It will also play a key role in supporting ECDC's risk analysis, assessment of public health advice and strategic planning.
30th May 2022 - ECDC.Europa.eu

Medical research stalled as NHS focuses on small number of trials, experts say

Government efforts to focus NHS resources on a smaller number of well-designed clinical trials could inadvertently be contributing to a backlog of stalled medical research, and result in some important trials being scrapped, researchers say. Their warning comes as a report outlines the scale of “research waste” that has occurred during the pandemic, with rampant duplication of scientific efforts and weakly designed clinical trials exposing millions of patients to unproven treatments, with little scientific benefit.
30th May 2022 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th May 2022

View this newsletter in full

Covid-19 and mRNA technology are helping Africa fix its vaccine problems

After the disastrous effect of vaccine nationalism on access in Africa, boosting local production is key to preventing a repeat in future pandemics. WHO’s new mRNA vaccine hub is at the forefront, report Emma Bryce and Sandy Ong In June 2021, the World Health Organization selected South African biotech company Afrigen to be part of the “hub” where mRNA technology—which underpins the most effective covid-19 vaccines—would be developed and shared with other lower and middle income countries.1 More than 15 manufacturers (“spokes”) have been named so far, almost half located in Africa.2 For the world’s second largest continent, by size and population, this initiative has come not a moment too soon. Africa uses one quarter of global vaccines but produces just 1%3—a shortage that left it wrong footed as covid-19 swept the globe and rich nations hoarded vaccine supplies.
28th May 2022 - The BMJ

U.S. doctors reconsider Pfizer's Paxlovid for lower-risk COVID patients

Use of Pfizer Inc's COVID-19 antiviral Paxlovid spiked this week, but some doctors are reconsidering the pills for lower-risk patients after a U.S. public health agency warned that symptoms can recur after people complete a course of the drug, and that they should then isolate a second time. More quarantine time "is not a crowd-pleaser," Dr. Sandra Kemmerly, an infectious disease specialist at Ochsner Health in New Orleans, told Reuters. "For those people who really aren't at risk ... I would recommend that they not take it."
28th May 2022 - Reuters

Previous COVID-19 or MIS-C does not protect kids from omicron, study finds

Research drawing on the national Overcoming COVID-19 study, led by Boston Children's Hospital, and the hospital's own Taking On COVID-19 Together Group provides evidence that children who previously had COVID-19 (or the inflammatory condition MIS-C) are not protected against the newer omicron variant. The researchers obtained blood samples from 62 children and adolescents hospitalized with severe COVID-19, 65 children and adolescents hospitalized with MIS-C, and 50 outpatients who had recovered from mild COVID-19. All the samples were taken during 2020 and early 2021, before the emergence of the omicron variant. The researchers obtained blood samples from 62 children and adolescents hospitalized with severe COVID-19, 65 children and adolescents hospitalized with MIS-C, and 50 outpatients who had recovered from mild COVID-19. All the samples were taken during 2020 and early 2021, before the emergence of the omicron variant.
28th May 2022 - Medical Xpress

Exploring antigenic traits of SARS-CoV-2 Omicron BA.5 and BA.4 subvariants

SARS-CoV-2 mutants have emerged constantly throughout the coronavirus disease 2019 (COVID-19) pandemic. The SARS-CoV-2 Omicron BA.2 and BA.1 lineages appeared in late November 2021 in South Africa and harbor a substantial antigenic gap from prior SARS-CoV-2 variants and existing vaccine strains, yet a minor antigenic distance between each other. BA.4 and BA.5, the most recent SARS-CoV-2 Omicron mutants to appear, were initially discovered in Southern Africa, where they are causing the present wave of SARS-CoV-2 infection. In addition, the Omicron BA.5 and BA.4 sublineage cases were elevating quickly in various European nations. BA.5 and BA.4 encode similar spike (S) proteins and are more closely associated with BA.2. They share multiple mutations with BA.2, including Δ69-70, F486V, and L452R, but neither has the Q493R alteration compared to BA.2.
28th May 2022 - News-Medical.Net

Scientists identify ‘trigger molecule’ for Covid-related changes to smell

Scientists have identified the “trigger molecule” that makes pleasant aromas smell like burning rubbish or sewage in people whose sense of smell is disrupted by Covid. The loss of smell is a defining symptom of Covid-19, with about 18% of adults in the UK estimated to have been affected. Some people also experience disturbances in their sense of smell – a condition known as parosmia – but the biological basis for this has remained a mystery. Now scientists have identified a highly potent odour molecule that appears to be a trigger for the sense of disgust experienced by many of those with parosmia. The molecule, called 2-furanmethanethiol, found in coffee, was described by those with a normal sense of smell as being coffee- or popcorn-like, but those with parosmia typically described its scent as disgusting, repulsive or dirty.
28th May 2022 - The Guardian

Nasal COVID-19 vaccines help the body prepare for infection right where it starts – in your nose and throat

Covid-19 news: Reinfection eight times higher with omicron than delta

When the omicron variant was dominant in the UK, the risk of reinfection was about eight times higher than when the delta variant prevailed In the UK, the risk of being reinfected with covid-19 was considerably more likely when the omicron variant was dominant, from 20 December 2021 to 13 May 2022, compared with when the delta variant was surging, defined as 17 May to 19 December 2021, according to the Office for National Statistics (ONS). The finding is part of the ONS’ Coronavirus Infection Survey, which measures how many people are testing positive for covid-19 and the prevalence of antibodies against the virus across the UK.
28th May 2022 - New Scientist

Dominant coronavirus mutant contains ghost of pandemic past

The coronavirus mutant that is now dominant in the United States is a member of the omicron family but scientists say it spreads faster than its omicron predecessors, is adept at escaping immunity and might possibly cause more serious disease. Why? Because it combines properties of both omicron and delta, the nation’s dominant variant in the middle of last year. A genetic trait that harkens back to the pandemic’s past, known as a “delta mutation,” appears to allow the virus “to escape pre-existing immunity from vaccination and prior infection, especially if you were infected in the omicron wave,” said Dr. Wesley Long, a pathologist at Houston Methodist in Texas. That’s because the original omicron strain that swept the world didn’t have the mutation.
28th May 2022 - The Associated Press

First steps in reforming global health emergency rules agreed at WHO meeting

Countries have agreed to an initial U.S.-led push to reform of the rules around disease outbreaks, known as the International Health Regulations, after early opposition from Africa and others was overcome this week, sources told Reuters on Friday. The amendments, once confirmed by the World Health Organization (WHO) assembly, are one of a handful of concrete outcomes from a meeting seen as a once-in-a-generation chance for the U.N. health agency to strengthen its role following some 15 million deaths during the COVID-19 pandemic. The reform sought by Washington and backed by others like Japan and the European Union is a first step in a broader reform of the IHR, which set out countries' legal obligations around disease outbreaks, expected to take up to two years.
28th May 2022 - Reuters

Sotrovimab drives SARS-CoV-2 omicron variant evolution in immunocompromised patients

Sotrovimab is a monoclonal antibody used as monotherapy in outpatients at risk of developing severe COVID-19 disease. Indications include patients with respiratory, cardiac, metabolic, and immunosuppression comorbidities. Rockett and colleagues1 have shown that, among 100 patients infected with the delta (B.1.617.2) variant and treated with sotrovimab monotherapy, four were immunocompromised and rapidly developed resistant mutations in the spike protein at positions 337 or 340, or both. These mutations are associated with prolonged excretion and in-vitro resistance.1 , 2 Given that sotrovimab is one of the few monoclonal antibodies that retains efficacy against the widely circulating omicron BA.1 sublineage, monitoring the prevalence of these mutations is crucial.3
27th May 2022 - The Lancet

Study: Lingering cough, fatigue more common in Omicron patients

Patients suffering from COVID-19 aftereffects were more likely to have persistent coughs and fatigue if they were infected with the Omicron variant instead of the Delta or other strains, a survey showed. The survey by the Tokyo metropolitan government was based largely on data collected from eight hospitals run by the metropolitan government or the Tokyo Metropolitan Health and Hospitals Corporation. These hospitals offer telephone consultations to patients experiencing long-term effects of COVID-19. The Tokyo Center for Infectious Disease Control and Prevention analyzed consultation records for 2,039 patients who tested positive for the Omicron variant between January and April.
27th May 2022 - The Asahi Shimbun

The Best and Worst Places to Be in a World Divided Over Covid

Most of the world is now living alongside Covid-19, with the omicron variant penetrating parts of the globe that avoided the worst of the early pandemic, triggering record waves in places like New Zealand and Taiwan. In Europe and North America, while life has largely normalized, there’s still a constant stream of Covid fatalities—especially in the US and UK. The ability to open up with low levels of death is why Norway retains the No. 1 position in Bloomberg’s Covid Resilience Ranking for a third month. A 91% vaccination rate in adults has helped the Nordic country keep its fatality rate low, despite a consistently circulating virus. Ireland comes in second in May, while Denmark overtakes the United Arab Emirates for third as it emerges from an omicron-fueled wave.
27th May 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th May 2022

View this newsletter in full

WHO asks countries to increase surveillance for Monkeypox

About 200 confirmed and more than 100 suspected cases of Monkeypox have been detected so far outside of the countries where it usually spreads, a World Health Organization official said on Thursday, urging countries to increase surveillance for the infectious disease. Monkeypox, a mild viral infection, is endemic in the African countries of Cameroon, Central African Republic, Democratic Republic of Congo, and Nigeria.
26th May 2022 - Reuters

Rebound COVID Is Just the Start of Paxlovid's Mysteries

The first data on Paxlovid, out last November, hinted that the COVID antiviral would cut the risk of hospitalization and death by 89 percent. Pundits called the drug “a monster breakthrough,” “miraculous,” and “the biggest advance in the pandemic since the vaccines.” “Today’s news is a real game-changer,” said Albert Bourla, the CEO of Pfizer, which makes the drug. The pills are “a game changer,” President Joe Biden repeated a few months later. Now, finally, the game is being changed. The government has ordered 20 million courses of Paxlovid, committing half of the $10 billion in additional COVID funding that is being negotiated in the Senate; and Pfizer says that the number of patients taking the drug increased by a factor of 10 between mid-February and late April.
26th May 2022 - The Atlantic

Children urged to come forward for Covid booster trial in these ten areas

Children aged between 12 and 15 are being urged to volunteer for a new study exploring different options for a third Covid booster vaccine. The University of Oxford-led Com-COV 3 study aims to recruit 380 volunteers across 10 UK sites, including Oxford's Churchill Hospital. Those taking part will need to have received two doses of the Pfizer-BioNTech vaccine, at least three months before joining. Researchers will then deliver a third dose as part of the study.
26th May 2022 - ITV News

Mucosal COVID vaccine candidate powerfully protective in macaques

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is capable of infecting people of any age. Although COVID-19 is often mild in young children relative to adults, thousands of children have been admitted to hospitals in the United States (US) owing to SARS-CoV-2 infection, with around one-third of them having no prior medical issues. Over 800 US children aged 0 to 11 years have died from COVID-19, and during the 2021/2022 fall/winter SARS-CoV-2 outbreak in the US, children constituted more than 25% of COVID-19 cases. Moreover, COVID-19 rarely produces a multisystem inflammatory disease in children (MIS-C).
26th May 2022 - News-Medical.Net

Long COVID risk falls only slightly after vaccination, huge study shows

Vaccination against SARS-CoV-2 lowers the risk of long COVID after infection by only about 15%, according to a study of more than 13 million people1. That’s the largest cohort that has yet been used to examine how much vaccines protect against the condition, but it is unlikely to end the uncertainty. Long COVID — illness that persists for weeks or months after infection with SARS-CoV-2 — has proved difficult to study, not least because the array of symptoms makes it hard to define. Even finding out how common it is has been challenging. Some studies2,3 have suggested that it occurs in as many as 30% of people infected with the virus. But a November study4 of about 4.5 million people treated at US Department of Veterans Affairs (VA) hospitals suggests that the number is 7% overall and lower than that for those who were not hospitalized.
26th May 2022 - Nature.com

Newcastle's QuantuMDx Group launches rapid COVID-19 and flu test

A life sciences firm has unveiled new technology it says can identify COVID-19, flu and respiratory illnesses in minutes. Newcastle-based QuantuMDx Group says its Q-POC equipment provides “differential diagnosis” and will enable “rapid triage and effective treatment strategies, particularly in at-risk groups of patients”. Bosses say it will help identify co-infection earlier, which will shorten treatment and patient hospital stays, with test results returned in 35 minutes. Jonathan O’Halloran, chief executive [pictured above], said: “The recent COVID-19 pandemic highlighted the need for rapid, high-quality PCR panels to accurately diagnose infectious diseases, and so I am pleased to announce the launch of this new respiratory panel. “With the coming winter likely to bring parallel pressure from these viruses, on-demand rapid accurate PCR testing has the potential to provide clinicians with an optimum solution for respiratory infection control.
26th May 2022 - North East Times

Multi-inflammatory index predicts mortality in critically ill COVID-19 patients

A multi-inflammatory index (MII) biomarker have been shown to have good predictive power for mortality among COVID-19 patients admitted to an intensive care unit (ICU). This was the main finding of a study by a team of Turkish researchers.
26th May 2022 - Hospital Healthcare Europe

COVID-19 in babies – here's what to expect

Parents are understandably worried about what would happen if their infant caught COVID-19. Babies may be considered vulnerable due to immature immune systems, and are also not eligible for most of the treatments and vaccinations available for older children and adults. The good news is, most babies experience mild illness. Here’s what to expect if your baby tests positive.
26th May 2022 - The Conversation

COVID-19: Amyloids could explain blood clots, neurological symptoms

The cause of the many mysterious and lingering symptoms brought on by SARS-CoV-2 infection, or COVID-19, has remained a hard-to-solve puzzle for scientists. Researchers have been looking into various systems in the body in an effort to find answers. A sometimes controversial area of study has been micro clots in people with long COVID, caused by fibrin, which is a substance that contributes to coagulation. This has made both the immune system and circulatory system interesting candidates for further study. A recent study, published in the Journal of American Chemical Society, has provided a suggested mechanism to explain why some people develop complicated COVID-19 symptoms after infection.
26th May 2022 - Medical News Today

COVID-19: 55% of early pandemic survivors still symptomatic 2 years on

The first cases of COVID-19 were reported in Wuhan, Hubei Province, China in December 2019Trusted Source. It has now been over two years since the beginning of the outbreak connected to the Huanan Seafood Wholesale Market in Wuhan. Since then, many COVID-19 survivors have reported lingering health issues or symptoms that suddenly appear months and even a year after the initial infection. It is important to note that these patients experienced COVID-19 before vaccines were developed against SARS-CoV-2. A recent study looked into the current conditions of COVID-19 patients from Wuhan two years later.
26th May 2022 - Medical News Today

Should You Use a Pulse Ox When You Have COVID-19?

The primary treatment for low oxygen levels is oxygen therapy. Oxygen therapy gets oxygen into your bloodstream and helps take the pressure off your lungs so that you recover from COVID-19. There are a few ways to receive oxygen therapy. In most cases, you’ll receive extra oxygen through a nasal cannula. A nasal cannula is plastic tubing that sits in your nose. Oxygen from a tank goes into the tubing and then into your body. Doctors and respiratory therapists can adjust the amount of oxygen you receive until your blood oxygen levels return to normal. As you start to recover, they can slowly reduce the amount of oxygen you receive through the tubing.
26th May 2022 - Healthline.com

Long COVID affects more older adults; shots don’t prevent it

New U.S. research on long COVID-19 provides fresh evidence that it can happen even after breakthrough infections in vaccinated people, and that older adults face higher risks for the long-term effects. In a study of veterans published Wednesday, about one-third who had breakthrough infections showed signs of long COVID. A separate report from the Centers for Disease Control and Prevention found that up to a year after an initial coronavirus infection, 1 in 4 adults aged 65 and older had at least one potential long COVID health problem, compared with 1 in 5 younger adults. Long COVID refers to any of more than two dozens symptoms that linger, recur or first appear at least one month after a coronavirus infection. These can affect all parts of the body and may include fatigue, shortness of breath, brain fog and blood clots.
26th May 2022 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th May 2022

View this newsletter in full

New Study Shows Vaccination Reduces Long Covid Risk, But Modestly

Vaccination reduces your risk of developing long Covid, but not by much on average, new research suggests. A Veterans Affairs study out Wednesday found that vaccinated people with breakthrough Covid-19 infections had a 15% reduction in experiencing persistent or new symptoms and health conditions up to six months after infection compared with those who were unvaccinated and got Covid.
26th May 2022 - The Wall Street Journal

Heart-Failure Drug Used to Treat Long Covid Symptoms

More than 200 symptoms can afflict those dealing with the aftereffects of Covid-19. An emerging approach to treating one of them—heart palpitations—highlights the successes scientists are having in addressing the symptoms, even if it may take years to understand how they’re caused. About 11% of coronavirus patients report experiencing palpitations or an increased heart rate, according to a meta-analysis of long-Covid studies published in the journal Scientific Reports in August. The symptoms are suggestive of a broader condition called postural orthostatic tachycardia syndrome, or POTS, which affects more than 24 million Americans—a number that’s growing because of Covid. POTS is more prevalent among women of childbearing age; often coincides with lightheadedness, brain fog, and gastric upset; and can eventually lead to chronic fatigue.
26th May 2022 - Bloomberg

AstraZeneca reviews diversity in trials to ensure drugs work for all

The pharmaceutical giant AstraZeneca is conducting a major review of diversity across its trials in an attempt to ensure its medicines work for all population groups, although it has admitted that including pregnant women is a particular challenge. The head of oncology at Britain’s biggest drugmaker, David Fredrickson told the Guardian that the firm was among those leading efforts to improve participation of people of colour and other under-represented groups in clinical trials. Speaking on the sidelines of the World Economic Forum’s annual meeting in Davos, he called it applying an “equity lens” to every phase of the medicine’s lifecycle.
25th May 2022 - The Guardian

Vaccines may not prevent many symptoms of long covid, study suggests

A large U.S. study looking at whether vaccination protects against long covid showed the shots have only a slight protective effect: Being vaccinated appeared to reduce the risk of lung and blood clot disorders, but did little to protect against most other symptoms. The new paper, published Wednesday in Nature Medicine, is part of a series of studies by the Department of Veterans Affairs on the impact of the coronavirus, and was based on 33,940 people who experienced breakthrough infections after vaccination. The data confirms the large body of research that shows vaccination greatly reduces the risk of death or serious illness. But there was more ambiguity regarding long covid.
25th May 2022 - The Washington Post

COVID nasal sprays could offer advantages over traditional vaccines – a virologist explains how they work

As new waves of omicron infections continue to hit around the world, it’s becoming clearer that COVID is here to stay. As such, in the years to come, vaccination – both first courses and booster doses – will likely remain necessary to brace global communities against the worst health outcomes wrought by the virus. But what if the current crop of vaccines could be improved? Recent advances in vaccine technology and delivery systems suggest there could be gains to be made. In particular, scientists are working on vaccines that activate your “mucosal” immune system, which may be better able to prevent infection with SARS-CoV-2, the virus that causes COVID-19
25th May 2022 - The Conversation

Covid survivors face double risk of getting lung blood clots, CDC study warns

Survivors of Covid-19 have twice the risk of developing a blood clot in the lungs or a respiratory condition, according to a new study by the US’ Centers for Disease Control and Prevention (CDC). Published on Tuesday, the study by the US government body said adults aged between 18 and 64 years have an increased risk of developing pulmonary embolism – a clot in an artery of the lung – or other respiratory conditions like chronic cough or shortness of breath. One in five Covid survivors in this age range and one in four survivors over the age of 65 years have experienced “at least one incident condition that might be attributable to the previous infection”, it said.
25th May 2022 - The Independent

Persistent multiple organ damage noted with COVID-19

A multicenter Scottish study reveals persistent multisystem abnormalities among 159 COVID-19 patients 28 to 60 days after release from the hospital, including cardio-renal inflammation, diminished lung function, worse quality of life, and poor outcomes. In the study, published yesterday in Nature Medicine, a team led by University of Glasgow researchers collected serial blood biomarkers and patient-reported outcomes and performed digital electrocardiography, chest computed tomography (CT) with pulmonary and coronary angiography, and cardio-renal (heart-kidney) magnetic resonance imaging (MRI) in the hospital and 28 to 60 days later. For longer-term outcomes, the researchers accessed electronic health records.
25th May 2022 - Cidrap.umn.edu

The future of Paxlovid for COVID-19

In comments to Bloomberg published on May 3, 2022, Pfizer chief executive officer Albert Bourla suggested that patients who experience a relapse of symptoms after finishing a course of the company's COVID-19 antiviral, Paxlovid, should take a second course of the drug. Yet the emergency use authorisation issued by the US Food and Drug Administration (FDA) stipulates that Paxlovid is “not authorized for use longer than five consecutive days”. On May 4, John Farley, director of the Office of Infectious Diseases at the FDA, reiterated this message. “There is no evidence of benefit at this time for a longer course of treatment...or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course”, stated Farley.
25th May 2022 - The Lancet

CDC: COVID survivors struggle with pulmonary embolisms, breathing issues

A large study of adults in the United States who survived COVID-19 during the first 2 years of the pandemic found that they had twice the risk of developing pulmonary embolism or respiratory conditions in the year following infection. In other developments, US Centers for Disease Control and Prevention (CDC) tracking today shows that the more transmissible BA.2.12.1 Omicron subvariant is now the dominant strain, as illness levels continue a steady rise across the country.
25th May 2022 - CIDRAP

We're finally learning more about long Covid

Vaccines, variants, natural immunity and better treatment options mean catching Covid-19 now isn't the same as it was a year or two ago. But for millions of people who contracted the virus even in the pandemic's first months, the impact of the disease lingers. As many as one in five adults who recovered from a Cov id-19 infection have experienced at least one medical condition relating to long Covid, according to a study published Tuesday by the US Centers for Disease Control and Prevention (CDC). That figure jumps to one in four in people aged 65 and older. The most common conditions among all adults were respiratory symptoms and musculoskeletal pain, the researchers found. Covid patients were also twice as likely as other people to have conditions affecting the lungs.
25th May 2022 - CNN

Women twice as likely to suffer from long Covid, study suggests

Women are more than twice as likely as men to suffer from long Covid, according to the largest study of the condition to date, which found a history of autoimmune disease or depression also increased the likelihood of experiencing symptoms. The study by genetic testing company 23andMe surveyed more than 100,000 people who had Covid-19, about a quarter of whom reported having experienced long Covid — where symptoms such as breathing problems, fatigue and brain fog last for more than 12 weeks. Some 7,000 of these had been formally diagnosed.
25th May 2022 - Financial Times

The future of Paxlovid for COVID-19

In comments to Bloomberg published on May 3, 2022, Pfizer chief executive officer Albert Bourla suggested that patients who experience a relapse of symptoms after finishing a course of the company's COVID-19 antiviral, Paxlovid, should take a second course of the drug. Yet the emergency use authorisation issued by the US Food and Drug Administration stipulates that Paxlovid is “not authorized for use longer than five consecutive days”. On May 4, John Farley, director of the Office of Infectious Diseases at the FDA, reiterated this message.
25th May 2022 - The Lancet

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th May 2022

View this newsletter in full

WHO says monkeypox containable, convening research meeting to support member states

The outbreak of monkeypox cases outside of Africa can be contained, the World Health Organization said on Tuesday, as more governments said they would launch limited vaccinations to combat rising infections of the virus. The moves came as authorities investigated 237 suspected and confirmed cases of the virus in 19 countries since early May. That number is expected to increase, WHO officials have said, but most of the infections so far have not been severe.
24th May 2022 - Reuters

Vaxzevria Gains Approval in EU as a Third Dose COVID-19 Booster in Adults

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU. AstraZeneca has revealed in a May 23, 2022 press release, that its recombinant COVID-19 vaccine originally invented by the University of Oxford, Vaxzevria (ChAdOx1-S), has been given the nod by the European Medicines Agency (EMA) as a third dose booster vaccine for use in the European Union (EU). Through this latest market authorization, healthcare professionals will be able to use the vaccine as a third dose booster in patients who have already been administered a primary vaccine schedule of either Vaxzevria or other EU-approved messenger RNA (mRNA) COVID-19 vaccines. The authorization has been based on EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation, for which there was a review of data demonstrating an increased immune response with a third dose booster Vaxzevria jab.
24th May 2022 - PharmTech

Pfizer/BioNTech COVID-19 vaccine produces strong immune response in children

Pfizer and BioNTech have announced recent data from a top-line safety, immunogenicity and vaccine efficacy phase 2/3 trial assessing a third 3µg dose – one-tenth of the adult dosage – of their COVID-19 vaccine for children aged from six months to under five years old. The vaccine resulted in a strong immune response following the third dose in this particular age group, and showed a positive safety profile similar to placebo. One of the second endpoints in the trial was vaccine efficacy, which was 80.3% in children aged six months to under five years. This analysis was taken during a period when the Omicron strain was the predominant variant, and was based on ten symptomatic COVID-19 cases identified seven days after the third dose and accrued as of 29 April 2022.
24th May 2022 - PMLiVE

Ocugen gets FDA approval to resume COVID vaccine trial

Bharat is seeking approval for the shot in more than 60 other countries, even amid declining demand for COVID-19 vaccines worldwide. Europe recently delayed deliveries from Pfizer and BioNTech by three months. Earlier this month, Bloomberg reported that Johnson & Johnson’s vaccine manufacturing partner in South Africa, Aspen, had received no orders.
24th May 2022 - FiercePharma

Are COVID Vaccines Still Blocking Severe Disease?

The shots aren’t perfect: They can’t completely block infections or keep the debilitating symptoms of long COVID at bay. Still, against the severest outcomes, “I think vaccination is holding up,” Ali Ellebedy, an immunologist at Washington University in St. Louis, told me. “It provides a lot of comfort, just knowing that layer is there,” says Natalie Dean, a biostatistician at Emory University.
24th May 2022 - The Atlantic

Pfizer to seek US emergency approval of Covid vaccine for under 5s

Pfizer has said it will seek emergency authorisation in the US for its Covid-19 vaccine for children under the age of five after interim results from its clinical trial showed the jab is safe and highly effective. The US drugmaker said on Monday that three doses of its children’s jab — each about a tenth of the size of an adult dose — produced a strong immune response with a favourable safety profile similar to a placebo in the age group.
24th May 2022 - Financial Times

Higher air pollution linked to more severe cases of COVID-19, study suggests

People living in areas with higher levels of air pollution are more likely to develop severe COVID-19 illness that leads to hospitalization and even death, a new study suggests. The research, published Tuesday in the Canadian Medical Association Journal (CMAJ), found an elevated likelihood of hospitalization, admission to an intensive care unit and death among COVID-19 cases who were chronically exposed to fine particulate matter, nitrogen dioxide and ground-level ozone. “These results suggest that chronic exposure to air pollution before SARS-CoV-2 infection may contribute to COVID-19 severity, particularly chronic exposure to (ozone),” the researchers write.
24th May 2022 - Global News

Covid-19 linked to impaired heart function, research finds

Covid-19 is associated with impaired function of the right side of the heart, a new study of intensive care patients has found. The research, led by experts from NHS Golden Jubilee, aimed to help improve future care and outcomes for those most at risk from Covid-19, by gaining a better understanding of the impact the virus has on the sickest patients who require invasive ventilation. The Covid-RV study was carried out in 10 intensive care units across Scotland and examined 121 critically ill patients who were receiving treatment on ventilators due to the impact of coronavirus on their system. Researchers found that about one in three of the patients in the study showed evidence of abnormalities in the right side of the heart – the area that pumps blood to the lungs.
24th May 2022 - The Independent

Covid-19: Vaccine effectiveness wanes more rapidly for cancer patients, study finds

Covid-19 vaccination is effective for cancer patients but protection wanes much more rapidly than in the general population, a large study has found. Vaccine effectiveness is much lower in people with leukaemia or lymphoma, those with a recent cancer diagnosis, and those who have had radiotherapy or systemic anti-cancer treatments within the past year, according to the research published in Lancet Oncology. The authors of the world’s largest real world health system evaluation of covid-19 in cancer patients highlighted the importance of booster programmes, non-pharmacological strategies, and access to antiviral treatment programmes in order to reduce the risk that covid-19 poses to cancer patients. The study, jointly led by the universities of Birmingham, Oxford, and Southampton and the UK Health Security Agency, included 377 194 people with active or recent cancer who had received two doses of a covid-19 vaccine, of whom 43 882 had breakthrough SARS-CoV-2 infections. The control population consisted of 28 010 955 people of whom 5 748 708 had a breakthrough infection.
24th May 2022 - The BMJ

Long Covid-19: 'I'm physically and mentally not able to do anything'

One Christmas, Michelle Kibble was given a mug with 'chaos coordinator' printed on the side because she was so busy juggling her full-time job in a pharmacy with being the main carer for her bed-bound father and running a small business with her husband of 25 years, Terry. But Michelle and Terry's lives changed forever when Michelle, 47, from Swindon, almost died after contracting Covid-19. It left her disabled, she lost her job, and became fearful of leaving the house in case she caught the virus again. In her own words, Michelle tells the BBC how the trauma has affected her family and how she is managing to cope.
24th May 2022 - BBC News

AstraZeneca says EU regulator approves COVID shot as booster

Drugmaker AstraZeneca said on Monday its COVID-19 vaccine, Vaxzevria, has been approved in the European Union by the bloc's drugs regulator as a third-dose booster in adults following a committee endorsement last week. The vaccine can now be used as a booster following the two-dose Vaxzevria schedule or by those who have been previously vaccinated by an mRNA vaccine, such as the ones made by Pfizer and BioNTech or Moderna.
24th May 2022 - Reuters

U.S. FDA sets June meeting dates for Moderna, Pfizer small children COVID-19 vaccines

The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc's emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc's vaccine for those aged 6 months through 4 years. The new dates for our pediatric COVID-19 vaccine advisory committee meetings will now be June 14 and June 15, the FDA said in a statement Monday.
24th May 2022 - Reuters

Germany's vaccine panel says one COVID shot enough for children

Germany's vaccine advisory panel on Tuesday said one COVID-19 shot was enough for healthy five- to 11-year-olds because most of them had already undergone an infection, maintaining its cautious approach. The view by the panel of 18 appointees, known as STIKO, contrasts with European Union regulators' approval for a two-shot regimen in that age group. U.S. regulators last week even authorized a third, booster shot for the group
24th May 2022 - Reuters

As reports of ‘Paxlovid rebound’ increase, Covid researchers scramble for answers

As he was treating some of the nation’s first coronavirus patients, Andre Kalil noticed something unusual about the new virus: Patients didn’t always progress linearly. They’d get better, then worse. Then sometimes better again. Initially, most researchers figured these undulating symptoms were collateral damage, as a riled-up immune system kept firing long after most of the virus was gone. Sometimes, though, Kalil could swab the lungs of a patient in the ICU and find virus still replicating weeks after they were admitted. Often, the amount of virus bounced up and down by the day. “I cannot tell you how many times I’ve seen patients that late in the disease, with very, very high viral load,” said Kalil, a physician and professor at the University of Nebraska Medical Center, home to the nation’s only federal quarantine center. “This virus is different than other viruses in the past. It has the capacity to replicate for much longer.”
24th May 2022 - STAT News

Kids' COVID syndrome—MIS-C—less severe in Omicron

COVID-19–related multisystem inflammatory syndrome in children (MIS-C) was milder amid the Omicron variant surge than during the Alpha and Delta waves in Israel, concludes a research letter published late last week in JAMA. Researchers from Rambam Health Care Campus in Haifa conducted prospectively studied all pediatric MIS-C patients at 12 Israeli hospitals during the same 16-week period in the Alpha (Dec 20, 2020, to Apr 10, 2021), Delta (Jul 18 to Nov 13, 2021), and Omicron (Nov 21, 2021, to Mar 12, 2022) pandemic waves. Participating hospitals account for roughly 70% of pediatric intensive care unit (ICU) admissions in Israel.
23rd May 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th May 2022

View this newsletter in full

WHO says no evidence monkeypox virus has mutated

The World Health Organization does not have evidence that the monkeypox virus has mutated, a senior executive at the U.N. agency said on Monday, noting the infectious disease that has been endemic in west and central Africa has tended not to change. Rosamund Lewis, head of the smallpox secretariat that is part of the WHO Emergencies Programme, told a briefing that mutations tended to be typically lower with this virus, although genome sequencing of cases will help inform understanding of the current outbreak.
24th May 2022 - Reuters

Three Doses of Pfizer’s Covid-19 Vaccine 80% Effective in Young Children, Company Says

Three doses of the Pfizer Inc. and BioNTech SE Covid-19 vaccine were 80% effective at preventing symptomatic Covid-19 and generated a robust immune response in children ages 6 months to 5 years old, the companies said. The vaccine was also found to be safe and well-tolerated among the children in the study, the companies said Monday. Many of the children had received at least some of their shots during the Omicron wave, suggesting that the three-dose series worked well against the highly contagious variant after the two doses produced mixed results. “We have a big problem called Omicron, and I think we have a good solution,” Pfizer Chief Executive Albert Bourla said in an interview. The companies reported the findings without much detail via press release based on an early analysis of study results.
24th May 2022 - The Wall Street Journal

FDA lifts hold on Ocugen's COVID-19 vaccine trial. But is it too late for the shot?

Six weeks after slapping a clinical hold on a trial of Ocugen’s COVID-19 vaccine, the FDA has lifted (PDF) it. That’s the good news for the Malvern, Pa. company, which has partnered with India’s Bharat Biotech on the shot known commercially as Covaxin. But the flip side for Ocugen is the declining demand for COVID vaccines in the United States. If Ocugen ever secures regulatory approval for Covaxin, will anyone want it—especially given the current surplus of available COVID jabs?
23rd May 2022 - FiercePharma

Women who are pregnant or nursing should receive a COVID booster vaccination

In the current work, the researchers examined humoral immunity elicited by the booster dose of SARS-CoV-2 mRNA vaccines in 63 subjects comprising breastfeeding, pregnant and age-matched nonpregnant females. They studied the antibody response to the spike (S) proteins of the SARS-CoV-2 Omicron and ancestral strains in a group of 12 nursing, 31 pregnant, and 20 nonpregnant age-matched volunteers who received an mRNA-1273 or BNT162b2 booster dose after completing the primary COVID-19 vaccination. Further, the researchers analyzed the transmission of vaccine-triggered antibodies in 15 maternal-cord pairs at delivery. The eligible subjects were lactating, pregnant, and nonpregnant women aged 18 to 45 years. Moreover, all included participants were vaccinated with SARS-CoV-2 mRNA booster dose between August and December 2021. The participants were selected from two tertiary care hospitals by practitioners or were self-referred. Blood samples were taken from all volunteers four weeks following the booster dose vaccination and at delivery in pregnant women. Furthermore, umbilical cord and maternal blood were obtained during delivery for 15 women who gave birth during the research period.
23rd May 2022 - News-Medical.Net

Largest study to date on the effect of vaccination on long-COVID

In a recent study published in the British Medical Journal, researchers evaluated the association between coronavirus disease 2019 (COVID-19) vaccination and long COVID symptoms among adults residing in United Kingdom (UK) communities with positive COVID-19 history before vaccination. COVID-19 vaccines have been effective in decreasing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, transmission, hospitalizations, and deaths. The likelihood of long COVID may be lower among individuals who are infected by SARS-CoV-2 after vaccination; however, the association between COVID-19 vaccination and long COVID symptoms is not clear.
23rd May 2022 - News-Medical.Net

City of Hope develops new immunotherapy to treat Covid-19

Scientists at City of Hope in the US have developed a novel immunotherapy that could offer a new treatment pathway for treating Covid-19 and other infections. The immunotherapy leverages natural killer (NK) cells with a specific molecule that can act on the spike protein of the SARS-CoV-2 virus. The study adds to the expertise of City of Hope in utilising CAR T cell therapy, natural killer cells and other immunotherapies to aid in detecting better therapies for cancer and other ailments.
23rd May 2022 - Pharmaceutical Technology

Long Covid 1: assessing the long-term health effects of Covid-19

Long Covid is more than a prolonged recovery from a respiratory infection; it is a multisystem, and potentially long-term and life-changing, disease. Many people carry the illness burden, including nurses, who may be disproportionately affected due to their high risk of Covid-19 infection. In this first in a series of three articles on long Covid, we look at what is known about the condition, its symptoms, causes and prognosis, and the nurse’s role, particularly in symptom management.
23rd May 2022 - Nursing Times

Drugmakers propose swift pandemic response benefiting poorer countries

Global drugmakers are lobbying for wealthy nations to fund a supply mechanism that would secure vaccines for low-income countries without delay in case of a new pandemic, but said the proposal was contingent on free cross-border trade. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said in a statement on Monday that global pandemic vaccine distribution needs to be put on a new footing because the world’s poorest countries were forced to wait for shots during the current pandemic.
23rd May 2022 - Reuters

AstraZeneca says EU regulator approves COVID shot as booster

U.S. drug regulator lifts clinical hold on Ocugen's COVID vaccine trial

Ocugen Inc said the U.S. drug regulator has lifted the clinical hold on a mid-to-late stage trial of the COVID-19 vaccine being developed by its Indian partner Bharat Biotech. The Food and Drug Administration paused the trials of the shot, Covaxin, in April after an inspection of a Bharat Biotech facility by the World Health Organization (WHO) revealed deficiencies in the manufacturing process.
23rd May 2022 - Reuters

Pfizer/BioNTech say three COVID shots generate good response in children under 5

Drugmakers Pfizer Inc and BioNTech SE said on Monday that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial. The companies said they plan to soon ask global regulators to authorize the shot for the age group, children for whom no vaccine is currently approved in most of the world. They said they expect to complete their submission of data to the U.S. Food and Drug Administration (FDA) this week.
23rd May 2022 - Reuters

Pfizer, BioNTech tout COVID booster data for young children and plan to finish FDA filing

Pfizer and BioNTech, after revealing positive data from a COVID-19 vaccine booster trial in young children, plan to complete their rolling FDA submission this week. The companies said that the safety, immunogenicity and vaccine efficacy data for the three-dose regimen were consistent with the data seen in adults. Efficacy reached 80.3% in the booster trial. Previously, a two-dose regimen failed to work in young children. The age group is the only one not yet cleared for a COVID-19 vaccine. The shots are one-tenth of the dose strength for adults. In the trial, 1,678 children received a third dose at a time when omicron was the dominant COVID-19 variant.
23rd May 2022 - FiercePharma

Vir, WuXi Biologics terminate COVID antibody pact as US rollout faces uncertain future

The U.S. distribution of Vir Biotechnology’s GSK-partnered COVID-19 antibody has been put on hold for more than a month. Now, a collaborator in the therapy wants out. WuXi Biologics has returned China rights to Vir’s COVID antibody, sotrovimab, the latter company said in a securities filing (PDF) published Friday. As part of the termination agreement, Vir will pay WuXi Bio $7 million to cover the Chinese CDMO’s development expenses. If sotrovimab is eventually approved in China, Vir is also on the hook to pay WuXi Bio tiered royalties on sales ranging from low single-digit percentages to low double-digit percentages, the company said.
23rd May 2022 - FiercePharma

Pfizer/BioNTech to seek Covid vaccine authorization for children under age 5

Vaccine makers Pfizer and BioNTech said they will complete their submission for emergency use authorization of their Covid-19 vaccine for children under the age of 5 this week after a study of a third dose found it improves the efficacy of the vaccine. Just hours after the news was made public, the Food and Drug Administration announced it expects to convene its independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, on June 15 to review the submission. The companies said that, with three doses, the vaccine performed about as well in young children as it does in adults. The vaccine was well-tolerated, induced a strong immune response, and was 80.3% effective at preventing Covid infections at a time when the Omicron variant of the SARS-CoV-2 virus was circulating.
23rd May 2022 - STAT News

Omicron breakthrough infections may spare young hearts; no need to delay mammogram after vaccination

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Omicron breakthrough infections may spare young hearts. The Omicron variant of the coronavirus does not have a negative affect on cardiovascular health in young adults who have been vaccinated, a small study suggests.
23rd May 2022 - Reuters

Monkeypox in Europe: Officials Call on Nations to Boost Efforts

As monkeypox cases climb in the UK, European health officials are calling on countries to review the availability of vaccines and step up efforts to identify and report new infections. Countries should check on supplies of smallpox vaccines, antiviral therapies and protective equipment for health workers, the European Centre for Disease Prevention and Control said Monday. The recommendations come as England reported that cases almost tripled to 56 from 20. The cousin of the smallpox virus has previously been mostly confined to regions in Africa, but health authorities are concerned about cases ticking up in Europe and North America. The World Health Organization had said that 92 cases and 28 suspected cases had been identified in 12 countries outside of those African nations where it is endemic as of May 21.
23rd May 2022 - Bloomberg

Smallpox Vaccine Enters Wider Production Amid Monkeypox Outbreak

Danish vaccine maker Bavarian Nordic A/S is making more of a smallpox vaccine typically stockpiled in case of biological warfare, as governments seek doses that also offer protection against monkeypox amid an unusual outbreak around the world. Monkeypox, a viral illness that is only rarely detected outside of Africa, has been reported in recent weeks in at least 17 countries including the U.S., U.K., Spain, Portugal and Australia, according to nonprofit data platform Global.health. In the U.S., a case was confirmed in Massachusetts and at least five more are suspected—one each in Florida, New York and Washington and two in Utah, state officials and the Centers for Disease Control and Prevention said Monday.
23rd May 2022 - The Wall Street Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd May 2022

View this newsletter in full

Bangkok Election: Candidates Pledge to Tackle Pollution

Thailand’s capital will vote for a new governor on Sunday for the first time in almost a decade with the winner facing the challenges of rebuilding Bangkok’s pre-pandemic status as a tourism hub and tackling persistent pollution. More than 4.4 million people, including an estimated 700,000 first-time voters, will pick the next governor from a list of 30 candidates for a four-year term. Polls close at 5 p.m. and unofficial results will be known by midnight, authorities said. Chadchart Sittipunt, a former transport minister contesting as an independent, has consistently led pre-election surveys with respondents backing him for his track record in improving public transport systems including the nation’s railways.
22nd May 2022 - Bloomberg

Hypoxemia in COVID-19–Related ARDS: Links to BMI, Prior Respiratory Disease

The presence of hypoxemia in patients with COVID-19–related acute respiratory distress syndrome (ARDS) is associated with such risk factors as body mass index (BMI) and prior respiratory illness, according to clinical trial results recently published in the Journal of Critical Care. Organized by the Argentine Society of Intensive Care Medicine, the SATICOVID19 clinical trial (ClinicalTrials.gov Identifier: NCT04611269), a prospective, multicenter cohort study, identified determinants of oxygenation over time (as measured by the ratio of arterial oxygen partial pressure to fractional inspired oxygen over days 1, 3, and 7 from ICU admission) among patients with COVID-19 ARDS. Study authors also analyzed the differences in physiological parameters, ventilation management, and outcomes over time associated with the 3 categories of ARDS severity outlined in the Berlin definition of ARDS.
21st May 2022 - Pulmonology Advisor

Monkeypox cases detected in US, Europe, but experts caution against comparing it to COVID-19

Countries in Europe and North America are continuing to report more cases of monkeypox, but experts say the disease so far does not pose a serious risk to the public. At least 17 infections of the rare disease have been confirmed in non-endemic areas such as the United States, United Kingdom, Portugal, Sweden and Italy, and dozens of possible cases are under investigation in those nations as well as in Canada and Spain.
21st May 2022 - ABC News

COVID-19 leading cause of death in people with diabetes in fourth quarter of 2020

The proportion of deaths attributed to COVID-19 in people with diabetes in the U.S. in the last 3 months of 2020 was slightly higher than the percentage of people who died due to cardiovascular disease or diabetes, according to study data. In a letter published in Diabetes Care, researchers found the rate of all-cause mortality in people with diabetes increased from the third quarter of 2019 through the fourth quarter of 2020, with the higher rate primarily due to a sharp increase in COVID-19 deaths.
21st May 2022 - Healio

COVID-19 could derail SDGs for next five years - report

The COVID-19 pandemic will further derail the UN’s Sustainable Development Goals (SDGs) in the next five years without concerted action, warn international scientists. The SDGs were adopted by the United Nations in September 2015, and call for governments and organisations to achieve goals such as ending poverty, eradicating hunger and ensuring everyone has access to clean, affordable energy by 2030. However, the economic fallout on the SDGs from COVID-19 was clear in 2020 when at least 255 million full-time jobs were lost, triggering a hunger crisis, especially in the global South, according to the report Unprecedented and Unfinished: COVID-19 and Implications for National and Global Policy published by the International Science Council (ISC).
21st May 2022 - SciDev.Net

Planning underway for Covid winter booster campaign

A COVID-19 winter booster campaign is being planned by the Scottish Government on the back of expert advice. The Joint Committee on Vaccination and Immunisation (JCVI) has recommended that, in order to maximise protection for the most vulnerable, boosters should be offered later this year to certain priority groups. The Government has now said it is working closely with NHS boards to plan for the rollout. Fourth doses of a vaccine are currently being offered to those aged 75 and over and people at highest risk. Health Secretary Humza Yousaf said: “The Scottish Government welcomes the interim advice from the JCVI that, in order to maximise protection in those most vulnerable to serious illness, COVID-19 booster vaccines should be offered to certain priority groups from this autumn. Prioritising those most at risk has been our approach from the outset.
21st May 2022 - The National

Welsh Government announces who will get Covid jabs this autumn

From this autumn, the Welsh Government has announced. The government has confirmed a list of those who will be offered a Covid jab between September and December this year following the Joint Committee on Vaccination and Immunisation's (JCVI) latest review of the existing vaccine programme in Wales. Following the review, the Welsh Government has confirmed it will offer a single dose of a Covid-19 vaccine to: Residents in a care home for older adults, and staff working in care homes for older adults, Frontline health and social care workers All those 65 years of age and over, Adults aged 16 to 65 years in a clinical risk group
21st May 2022 - Wales Online

Mysterious Hepatitis Outbreak in Children Spurs Global Race for Answers

Article reports that stomach bugs, Covid-19 and a normally harmless virus are among the suspects researchers have identified as possible drivers of a mysterious rash of hepatitis cases among children. Public-health researchers in the U.S., U.K and other parts of Europe are running studies aimed at pinpointing the cause of unexplained severe hepatitis, or liver inflammation, that has sickened more than 400 children around the world in recent months, leading to at least 26 liver transplants and at least six deaths. So far, they have few concrete answers.
21st May 2022 - The Wall Street Journal

U.S. CDC says adenovirus leading hypothesis for severe hepatitis in children

Infection with adenovirus, a common childhood virus, is the leading hypothesis for recent cases of severe hepatitis of unknown origin in children that have led to at least six deaths, U.S. health officials said on Friday. The Centers for Disease Control and Prevention (CDC) said it is continuing to investigate whether 180 cases identified in 36 states and territories since last October represent an increase in the rate of pediatric hepatitis or whether an existing pattern has been revealed though improved detection.
20th May 2022 - Reuters

At least 25m people in UK to be offered Covid booster this autumn

Millions of people in the UK will be offered further Covid booster shots in the autumn under draft guidance published by the government’s vaccine watchdog. The Joint Committee on Vaccination and Immunisation said another round of jabs would help protect the most vulnerable adults and frontline social care and health workers against severe Covid in the winter. Despite “considerable uncertainty” over the likelihood, timing and severity of any future wave of Covid in the country, the committee said the threat from the virus would be greatest in the winter months.
20th May 2022 - The Guardian

The quest for longer-lasting Covid-19 vaccines

China's commercial hub of Shanghai reported on Friday a broad decline in its economy last month when a city-wide COVID lockdown shut factories and kept residents at home, sparking concerns among foreign firms over their presence in the country. Output of Shanghai's industries, located at the heart of manufacturing in the Yangtze River Delta, shrank 61.5% in April from a year earlier, the local statistics bureau said.
20th May 2022 - CNN

Paxlovid Rebound: FDA Investigating Reports Of Covid-19 Relapses After Taking Pfizer Antiviral

For example, there’s that pre-print case report uploaded to Research Square on April 26, 2022, of a 71-year-old man who had been fully vaccinated and boosted against Covid-19. He began taking Paxlovid as soon as he had tested positive for Covid-19, two days after he had gotten exposed to the virus. His Covid-19 symptoms essentially disappeared after two days of Paxlovid, which seemed like a good thing. Yet, nine days after he had first tested positive and four days after he had completed the five-day course of Paxlovid, guess what happened? His runny nose, sore throat, and difficulty breathing returned, along with SARS-CoV-2 levels in his body going up again. It was like déjà eww all over again. Viral genome sequencing showed that during both his initial symptoms and his return of symptoms, he was infected with the BA.1 Omicron subvariant of the SARS-CoV-2. This suggested that he has experienced not two separate infections but a single one that improved before subsequently getting worse.
20th May 2022 - Forbes

North Korea's Dr Fauci? Health official emerges as face of COVID campaign

At 9:30 a.m. every day this week, a soft-spoken official has appeared on North Korean television to report the number of people with fever and new deaths, and to explain measures to stop North Korea's first confirmed COVID-19 outbreak. The little-known official, Ryu Yong Chol, has become the public face of the isolated country's battle against the epidemic, the equivalent of U.S. COVID-19 czar Dr Anthony Fauci or the director of South Korea's disease prevention agency, Jeong Eun-kyeong.
20th May 2022 - Reuters

COVID-19: JCVI recommends autumn booster jabs for some groups

Scientific advisers have sent the government their recommendations for who should be offered a COVID booster jab this autumn. Experts from the Joint Committee on Vaccination and Immunisation (JCVI) said the extra shot would help maintain protection over the winter against severe COVID-19. It recommends jabs for: • Over-65s • Care home residents and staff • Frontline health and social care workers • People over 16 in vulnerable groups
19th May 2022 - Sky News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th May 2022

View this newsletter in full

U.S. expert panel backs COVID boosters for children 5 to 11

The U.S. Centers for Disease Control and Prevention (CDC) on Thursday recommended the COVID-19 vaccine booster for children ages 5 to 11 after an advisory panel voted to back them, at least five months after completing their primary vaccination course. CDC Director Rochelle Walensky said in a statement that she "endorsed" the vote by the Advisory Committee on Immunization Practices "to expand eligibility for COVID-19 vaccine booster doses. Children 5 through 11 should receive a booster dose at least 5 months after their primary series."
20th May 2022 - Reuters

Why isn't there a nasal vaccine for Covid-19 yet?

Covid-19 vaccines have rapidly altered our relationship with SARS-CoV-2, turning a dangerous infection into something akin to the common cold for many vaccinated people who contract it. But while these vaccines are great at protecting against severe illness and death, they cannot stop vaccinated people from contracting the virus and experiencing mild symptoms. If we want to prevent mild Covid infections, we’re going to need vaccines that protect us where infections start: in the mucus membranes of the nose, mouth, and throat. And for that, we’re likely going to need intranasal vaccines. A number of research groups and companies are working on Covid-19 vaccines that would be delivered intranasally, but the development process is tricky. Watch the explainer above to learn more.
19th May 2022 - STAT News

Uzbekistan produces over 6 million doses of COVID-19 vaccine

Uzbekistan has produced 6.172 million doses of ZF-UZ-VAC 2001 coronavirus vaccine. Since start of coronavirus pandemic, Uzbekistan received 69.7 million doses of COVID-19 vaccines, including: - 2.6 million doses of AstraZeneca; - 48.1 million doses of ZF-UZ-VAC 2001; - 1.34 million doses of Sputnik V; - 10.68 million doses of Moderna; - 4.62 million doses of Pfizer/BioNTech; - 1.97 million doses of Sinovac; - 343,000 doses of Sputnik Light. More than 53 million doses of coronavirus vaccines were administered in Uzbekistan in total so far. 16.2 million doses of COVID-19 vaccines remain available.
19th May 2022 - AKIpress

Coronavirus vaccine could have saved 319,000 people in U.S., study says

About a third of the 1 million lives lost to COVID-19 could have been saved with vaccines, a new analysis shows. Researchers at the Brown School of Public Health, Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health and Microsoft AI for Health analyzed data from the Centers for Disease Control and Prevention and The New York Times and came up with not only 319,000 needless deaths but also a state-by-state breakdown of where they could have been prevented. Between January 2021 and April 2022, about every second person who died from COVID-19 since vaccines became available might have lived if they had gotten the shots, the researchers found. Nationwide, about half of the 641,000 people who have died since vaccines became available could have lived if every single eligible adult had gotten jabbed.
19th May 2022 - The Seattle Times

African J&J COVID vaccine orders mark a 'financial failure'

Late last year, Johnson & Johnson’s COVID production partner Aspen Pharmacare touted the game-changing potential of its “monumental” licensing deal to make and sell J&J’s single-dose shot in Africa. Five months later, and two months after Aspen started production, the effort has encountered a problem currently familiar to all pandemic vaccine manufacturers. Owing to a lack of demand—even in Africa where just 15.9% of the continent’s 1.2 billion population has completed a coronavirus vaccination course—Aspen hasn’t received a single order for its branded version of the J&J shot, Bloomberg reports. “There were a lot of calls both from the West and from Africa that the best way to try and solve the problem was to establish our own local vaccine production capacity,” Stavros Nicolaou, Aspen’s head of strategic trade, told the news outlet. The subsequent dearth of business “sends an incredibly bad message,” he added.
19th May 2022 - FiercePharma

How many Australians have died from COVID-19? How many have had COVID?

COVID-19 infections in Australia hit worldwide highs last week, with infection rates per capita among the highest around the globe. As the United States officially reached the grim milestone of 1 million deaths from COVID-19 this month, the recent stats have left some of us asking — how does our own country stack up in comparison? Infections rose by more than 60% in the Middle East and 26% in the Americas, while deaths fell everywhere except Africa, where they jumped by nearly 50%. The COVID-19 figures reported to WHO do not include the recent outbreak figures announced by North Korea, which has yet to officially share requested data with the agency.
19th May 2022 - ABC News

Trajectory of long covid symptoms after covid-19 vaccination: community based cohort study

The likelihood of long covid symptoms was observed to decrease after covid-19 vaccination and evidence suggested sustained improvement after a second dose, at least over the median follow-up of 67 days. Vaccination may contribute to a reduction in the population health burden of long covid, although longer follow-up is needed.
19th May 2022 - The BMJ

EU's drug regulator accepts Valneva's COVID-19 vaccine marketing authorization filing

The European Union's medicine regulator accepted Valneva's filing of marketing authorization application for its inactivated COVID-19 vaccine candidate, the French company said on Thursday. "The Company confirms it would expect to receive a positive CHMP opinion in June", Valneva said. Earlier this week, Valneva nearly a fifth of its value on the stock exchange after announcing its COVID-19 vaccine agreement with the European Commission was likely to be scrapped and it might have to rethink its financial guidance.
19th May 2022 - Reuters

WHO clears COVID vaccine by China's CanSino Biologics for emergency use

The World Health Organization on Thursday issued an emergency use listing for the single-dose COVID-19 vaccine from China-based CanSino Biologics. The vaccine, Convidecia, is the eleventh shot against the coronavirus to get clearance from the global health agency, whose advisory group recommended its use in people of age 18 years and above. The vaccine was found to have 64% efficacy against symptomatic disease and 92% against severe COVID-19, the agencysaid.
19th May 2022 - Reuters

Africa has contained monkey pox outbreaks during COVID pandemic - Africa CDC

Several outbreaks of monkey pox in Africa have been contained during the COVID pandemic while the world's attention was elsewhere, and outbreaks in Europe and the United States are a concern, Africa's top public health agency said on Thursday. A handful of cases of the virus, which causes fever symptoms and a distinctive bumpy rash, have been reported or are suspected in Britain, Portugal, Spain and the United States. The disease, which spreads through close contact and was first found in monkeys, mostly occurs in west and central Africa and only rarely spreads elsewhere. The acting director of the Africa Centres for Disease Control and Prevention said that since 2020 outbreaks had been seen and contained in the Democratic Republic of Congo, Nigeria, Cameroon and Central African Republic.
19th May 2022 - Reuters

COVID shows need for better information sharing early in pandemics, UK's Javid says

A lack of clear information out of China in the early stages of the coronavirus pandemic has left the whole world in a worse situation, British health minister Sajid Javid said. Javid, speaking before a G7 health ministers conference on Thursday where pandemic preparedness will be discussed, said that better information sharing would help avoid a repeat of the COVID crisis. He suggested that secrecy by China had contributed to a slow global response. Secretary of State for Health and Social Care's statement on the Ockenden Report.
19th May 2022 - Reuters

Vaccination after infection may curb long COVID; desktop 'air curtains' may deflect virus particles

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Post-infection vaccination may reduce long COVID Vaccination after infection with SARS-CoV-2 may contribute to a reduction in the burden of long COVID symptoms, a new study suggests. Researchers tracked 6,729 volunteers ages 18 to 69, who got two shots of either AstraZeneca's viral vector vaccine or an mRNA vaccine from Pfizer/BioNTech or Moderna after recovering from an infection with the coronavirus and who reported long COVID symptoms of any severity at least once between February and September 2021.
19th May 2022 - Reuters

Autumn Covid Booster Recommended for Elderly, Vulnerable in UK

UK vaccine advisers recommended a new round of Covid boosters for elderly and vulnerable people in the fall, saying the pandemic’s threat could mount again as winter approaches. Another shot should be offered to those 65 and older, care-home residents and staff, health and social workers, as well as people over 16 who are at higher risk, the Joint Committee on Vaccination and Immunization said Thursday. The new campaign would follow spring boosters for a more limited population. Although the spread of the coronavirus has eased in the UK in recent weeks, new variants could emerge, and studies have shown that protection from vaccination wanes with time. Despite uncertainty surrounding potential future waves, the threat remains highest in winter, the committee said.
19th May 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th May 2022

View this newsletter in full

Where to Find Paxlovid Once You've Tested Positive for Covid

As Covid-19 again surges across the US, many people are going without time-sensitive therapeutics like Paxlovid because doctors worried about shortages are reluctant to prescribe the drugs. But the situation has changed and supplies are now abundant. Paxlovid, a combination of pills taken for five days, cuts the risk of hospitalization by nearly 90%, according to the manufacturer, Pfizer Inc. But to be effective, it must be taken within five days of the onset of symptoms—which include everything from a scratchy throat, runny nose, cough and chills to fever, body aches, headache, nausea, vomiting, diarrhea, difficulty breathing and loss of taste or smell. The Food and Drug Administration has issued emergency-use authorizations for the drug to treat mild to moderate Covid-19 in people who are at high risk.
19th May 2022 - Bloomberg

COVID is rising in the Americas, virus 'not going away anytime soon' -PAHO

COVID-19 is on the rise again in the Americas as many countries have abandoned measures like masking and social distancing and many lag in vaccination rates, the Pan American Health Organization (PAHO) said on Wednesday. Cases in the Americas surged 27.2% last week from the prior one, driven primarily by a spike in infections in the United States, according to PAHO. More than half of a total 918,000 infections came from North America as U.S. cases jumped by 33% to 605,000 in the last week. Infections in North America have now been climbing for the past seven weeks.
19th May 2022 - Reuters

As COVID cases rise, U.S. health officials mull widening additional booster eligibility

Health officials are considering extending the eligibility for a second COVID-19 vaccine booster dose to people under 50 amid a steady rise in cases, with the United States seeing a threefold increase over the past month. The U.S. Food and Drug Administration had in late March authorized a second booster dose of the Moderna and Pfizer/BioNTech SE vaccines for people aged 50 and older, citing data showing waning immunity and the risks posed by Omicron variants of the virus.
19th May 2022 - Reuters

New FDA approved COVID-19 test

"New FDA approved COVID-19 test detects multiple viruses", a video on CBSNews.com.
18th May 2022 - CBS News

Pandemic science hub will develop drugs for lung infections such as Covid-19

A new pandemic science hub is being created to develop treatments for lung infections such as Covid-19. The hub at the University of Edinburgh will use translational genomics – following clues from the human genome to identify and rapidly test new treatments – along with experimental medicine methods to quickly evaluate and develop drugs for lung inflammation and injury caused by infection. Independent investment partnership Baillie Gifford is supporting the launch with a philanthropic gift of £14.7 million and the university aims to secure £100 million worth of investment in total. As well as accelerating discoveries of treatments for Covid-19 and other human lung diseases, the Baillie Gifford Pandemic Science Hub aims to help prepare for future pandemics.
18th May 2022 - The Independent

Estrogen treatment linked to reduced COVID-19 mortality

Women who received prescriptions for hormone replacement therapy (HRT) with estrogen within 6 months of a COVID-19 diagnosis had reduced mortality, according to a new study in Family Practice. The findings, coupled with data on sex differences between male and female COVID-19 severity, suggest estrogen may have a protective role against the virus. The study was based on medical records gathered from the Oxford-Royal College of General Practitioners Research and Surveillance Centre primary care database. Researchers looked at women ages 18 and older who received prescriptions for HRT or combined oral contraceptive pill, which contains estrogen. A total of 1,863,478 women from 465 general practices in England were included in the study. The main outcome was mortality among those with confirmed COVID-19 during the first 6 months of the pandemic in 2020.
18th May 2022 - CIDRAP

Does Paxlovid work in people vaccinated against Covid-19?

As a primary care doctor in New York City, I am grateful to drug companies for providing effective Covid-19 therapies for my patients. But I am also frustrated that these companies appear to be completely running the show, and believe that Americans could get more from Big Pharma if only our regulators dared to ask for it. This dynamic is on display with Paxlovid, which was approved based on a study that seems designed to exaggerate the benefit most Americans can expect from this drug rather than provide us with relevant information about it. Among antiviral agents for Covid-19, Pfizer’s Paxlovid has emerged as the clear winner for two reasons: First, as a pill, Paxlovid is easy to administer, compared to the infusions required for monoclonal antibodies and remdesivir. Second, Paxlovid appears to be highly effective, with a clinical trial showing an 89% relative reduction in hospitalizations or death among high-risk patients who receive it.
18th May 2022 - STAT News

A million have died of Covid-19 in America. How did this happen?

How did we get it here? How much of this mass death was preventable? These are questions that we will be sorting out for many years to come. There are no simple answers. In order to have a fighting chance in the next pandemic, though, it’s incumbent to consider just what went horrifically wrong. First, it must be noted that America, among advanced nations, was not alone in enduring terrible loss from Covid. Both the United Kingdom and Italy have comparable death rates. Multiple waves have overwhelmed other European nations with superior healthcare apparatuses. Taming a pandemic is incredibly difficult and few countries emerged unscathed.
18th May 2022 - The Guardian

COVID-19: Scientists receive £15m boost to tackle deadly respiratory illnesses following COVID study

Goutam Das doesn't remember much about his five weeks in intensive care with COVID-19. Mainly the nightmares, and struggling to breathe. "It's almost like if somebody puts you underwater. It's that kind of feeling... you're just desperate for oxygen." He's now back at work and putting his ordeal behind him. But while he was in the ICU, Goutam did not suffer entirely in vain. He's one of the thousands of people who became severely ill with COVID who gave a sample of their DNA to researchers based at the University of Edinburgh. It's now become a genetic resource that could be a goldmine for discovering new drugs - not just to treat COVID - but other forms of severe lung inflammation, one of the leading causes of death in intensive care.
18th May 2022 - Sky News

How can Covid-19 affect the human brain?

A study from Oxford university researchers published in March found tissue damage and shrinkage in parts of the brain related to smell in people. These effects could be associated with a pre-existing increased brain vulnerability to the deleterious effects of COVID-19.
18th May 2022 - Financial Times

AstraZeneca boosts COVID portfolio with RQ Bio deal

AstraZeneca moved to bolster its COVID-19 portfolio of antibodies on Tuesday with a $157 million licensing deal for experimental therapies developed by newly-launched biotech RQ Bio. In addition to the initial sum, the Anglo-Swedish drugmaker faces possible royalty payments as part of the exclusive licence to develop pre-clinical COVID antibodies engineered by RQ Bio, the start-up said. AstraZeneca announced the deal but not its size.
18th May 2022 - Reuters

World in no better place to fight pandemics than before COVID - review

The world is no better prepared for a new pandemic than it was when coronavirus emerged in 2019 and may actually be in a worse place given the economic toll, according to a panel set up by the World Health Organization (WHO) to evaluate the global response. A lack of progress on reforms such as international health regulations means the world is as vulnerable as ever, the Independent Panel for Pandemic Preparedness and Response said in its report.
18th May 2022 - Reuters

China Junshi's potential COVID drug shows promise in small trial

An antiviral oral drug being co-developed by Shanghai Junshi Biosciences' subsidiary and other Chinese institutes showed early promise in speeding the clearing of virus in COVID-19 patients, according to a small clinical trial. The drug, called VV116, is a derivative of Gilead Sciences Inc's COVID drug remdesivir and was approved for use in moderate to severe cases in Uzbekistan last year.
18th May 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th May 2022

View this newsletter in full

Pfizer COVID antiviral use up 315%, U.S. health department says

Rising COVID-19 cases are driving up the use of therapeutics, with Pfizer Inc's oral antiviral treatment Paxlovid seeing a 315% jump over the past four weeks, U.S. health officials said on Tuesday. The increase in U.S. cases and hospitalizations is starting to affect recommendations on behavior, with New York City, the nation's most populous city, advising stricter mask usage but stopping short of new mandates. Apple has scrapped return to office plans.
17th May 2022 - Reuters

U.S. FDA authorizes Pfizer's COVID booster shot for young children

The U.S. Food and Drug Administration on Tuesday authorized the use of a booster shot of Pfizer (PFE.N) and BioNTech's COVID-19 vaccine for children aged 5 to 11, making everyone in the country over the age of 5 eligible for a third shot. The U.S. Centers for Disease Control and Prevention (CDC) still needs to sign off on the shots before they can be administered. Children below the age of five are not yet eligible for a COVID-19 vaccine in the United States.
17th May 2022 - Reuters

COVID-19 vaccine study focuses on young and immunosuppressed

The team at Imperial College London will now expand the MELODY study to include immunosuppressed young people who have had an organ transplant, to assess the levels of protection the vaccines offer to immunosuppressed people across age groups. Dr Michelle Willicombe, the study lead at Imperial College London, commented: “Information on how young, immunosuppressed people have responded to vaccination and the protection it affords them from infection is currently lacking, so we are delighted for the additional support so we can include children in MELODY to provide ongoing evidence. “If we can understand more about how this group of people respond to vaccines, then this will inform future vaccination strategies and also identify those young people who are most at risk of catching COVID-19.”
17th May 2022 - PharmaTimes

COVID vaccines may cut hospital Omicron cases in youth

In the first study, researchers from the US Centers for Disease Control and Prevention analyzed data from 74,208 drive-thru polymerase chain reaction (PCR) COVID-19 test results from children aged 5 to 11 years, and 47,744 tests from aged 12 to 15 from Dec 26, 2021, to Feb 21, 2022. The tests were conducted by a single pharmacy chain at 6,897 sites in 49 states; Washington, DC; and Puerto Rico. The researchers compared the effectiveness of two Pfizer COVID-19 vaccine doses at least 2 weeks before testing with no vaccination in children, and two or three doses 2 or more weeks earlier in adolescents. Overall, the study involved 30,888 positive tests and 43,209 negative tests from children aged 5 to 11 and 22,273 positive tests and 25,471 negative tests from 12- to 15-year-olds. Median age was 10 years, 50.2% were girls, 70.1% were White, and 25.7% were Hispanic or Latino.
17th May 2022 - CIDRAP

Pfizer, BioNTech COVID vaccine deliveries delayed in Europe

As the EU gears up for a COVID-19 booster campaign this fall, the bloc has delayed vaccine deliveries from Pfizer and BioNTech. The change creates time for officials to secure potential variant-adapted shots that could score authorization in the months to come. Pfizer and BioNTech—which last year pledged to supply Europe with up to 1.8 billion doses of their mRNA vaccine Comirnaty through 2023—are pushing back deliveries scheduled for June through August by three months. The unspecified number of doses is now pegged to arrive in the EU starting in September through the fourth quarter of 2022, Pfizer and BioNTech said Monday. The delivery update shouldn’t crimp Pfizer and BioNTech’s 2022 revenue guidance or full-year delivery commitments to Europe, the companies said.
17th May 2022 - FiercePharma

Pfizer COVID-19 vaccine prevented almost 700,000 hospitalizations -study

The Pfizer-BioNTech COVID-19 vaccine prevented almost 700,000 hospitalizations in the US and saved more than $70 billion in costs over one year, a new study has found. Published on Sunday in the peer-reviewed Journal of Medical Economics, the study concluded that the vaccine prevented 8.7 million symptomatic cases of the virus in America as well as 690,000 hospitalizations and over 110,000 deaths. Additionally, it saved over $30 billion in healthcare costs and over $40 billion in lost productivity, the study found. The study's authors, who all received some form of funding from Pfizer, used a model with real-world and trial data to determine the number of symptomatic COVID-19 cases, hospitalizations and deaths that would have occurred without the Pfizer vaccine, as well as the cost on the healthcare system and the economy.
17th May 2022 - The Jerusalem Post

Flu vaccine could cut COVID risk

Influenza vaccines have a surprising health benefit: they might also prevent COVID-19, particularly in its most severe forms. A study of more than 30,000 health-care workers in Qatar found that those who got a flu jab were nearly 90% less likely to develop severe COVID-19 over the next few months, compared with those who hadn’t been recently vaccinated against flu. The study, which was conducted in late 2020, before the roll-out of COVID-19 vaccines, is in line with previous work suggesting that ramping up the immune system using influenza vaccines and other jabs could help the body to fend off the coronavirus SARS-CoV-2.
17th May 2022 - Nature

Sniffer dogs detect coronavirus as effectively as PCR tests

Airport sniffer dogs are highly adept at detecting the coronavirus, according to the first published results from a trial in Finland. Researchers said that in future pandemics dogs could be used “as the sole testing method when other approaches are not yet available”. A team of dogs at an airport in Helsinki were able to match the results of PCR tests 98 per cent of the time. The team behind the study, published in the online journal BMJ Global Health, said it showed sniffer dogs could “provide a valuable tool to contain the pandemic”.
17th May 2022 - The Times

Study: Readmission rate for COVID-19 is 11%

Eleven percent of Canadian patients who were discharged after hospitalization for COVID-19 were readmitted to the hospital or died within 30 days of discharge, according to a study today in CMAJ (Canadian Medical Association Journal). The retrospective cohort study was based on the medical records of all adults hospitalized in Alberta and Ontario for SARS-CoV-2 from Jan 1, 2020, to Sep 30, 2021. A total of 46,412 (5.5%) adults had a positive COVID-19 test 14 days prior or during their hospital admission. Of these, 8,496 died in hospital and 34,846 were discharged alive. Of those discharged, 30,336 had a typical hospital stay — 30 days or less. A total of 4,510 had a stay greater than 30 days, and 14% required intensive care unit admission. The median length of hospital stay was 8 days.
17th May 2022 - CIDRAP

COVID-19 vaccine uptake in pregnant women rising but stark inequality remains

Data for January 2022 from the UK Health Security Agency (UKHSA) show that almost six in 10 (59.6%) pregnant women had received one dose of COVID-19 vaccine. This is a significant rise in uptake from the 48.7% recorded in November 2021 and saw the total number of pregnant women who had received their first dose rise to 125,365 this January. Over half (50.6%) had received two doses of vaccine by January, another significant rise from the 38.4% recorded three months earlier. The total number of pregnant women double vaccinated by January was 88,736.
17th May 2022 - GP online

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th May 2022

View this newsletter in full

Omicron No Vaccine Substitute, But Breakthroughs May Beat Boosters

One potential silver lining is that vaccinated people catching breakthrough infections via the omicron variant may have a form of super-immunity more powerful than a booster shot, according to a couple of recent studies. Of course, given the risk of long Covid and how little we know about the disease’s long-term effects, nobody’s recommending you throw a Covid party. And unvaccinated people shouldn’t hope catching omicron will protect them from future infections, warns Lisa Jarvis. Even vaccinated people might find their super-immunity from an omicron infection won’t last more than a few months. Catch you at the next surge.
17th May 2022 - Bloomberg

Coronavirus may be linked to cases of severe hepatitis in children

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. SARS-CoV-2 could be at root of mysterious hepatitis in kids. A chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis reported in hundreds of young children around the world, researchers suggest.
16th May 2022 - Reuters

FDA declines to authorize common antidepressant as COVID treatment

The U.S. Food and Drug Administration has decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying that the data has not shown the drug to be an effective therapeutic for fighting the virus. "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization," the agency said in a document published on Monday.
16th May 2022 - Reuters

Shionogi starts COVID-19 vaccine clinical trial for adolescents

Osaka-based pharmaceutical company Shionogi says it has started a clinical trial for Japanese adolescents aged 12 to 19 of a coronavirus vaccine it is developing for all age groups. The product is a recombinant protein-based vaccine. For adult usage, the company is set to apply for approval with Japanese authorities as early as next month. The company said on Monday the clinical trial involves 350 adolescents. They will receive two doses to see whether their neutralizing antibody levels will equal those found in adults who have received the shots, or rise even higher.
16th May 2022 - NHK WORLD

Coronavirus: How Omicron infection turbocharges vaccinated people’s immunity

People who are vaccinated and then get infected with Omicron may be primed to overcome a broad range of coronavirus variants, early research suggests. A pair of studies showed that infection produced even better immune responses than a booster shot in vaccinated patients. Teams from Covid-19 vaccine maker BioNTech SE and the University of Washington posted the results on preprint server bioRxiv in recent weeks. The findings offer a reassuring sign that the millions of vaccinated people who’ve caught Omicron probably won’t become seriously ill from another variant soon – even though the research needs to be confirmed, especially by real-world evidence.
16th May 2022 - South China Morning Post

Long Covid: Staff suffering long-term coronavirus symptoms need more help to carry on working

Companies are failing staff suffering from long Covid leaving them open to legal action as the condition could amount to a disability under the Equality Act, an employment specialist has said. Aleksandra Traczyk, employment solicitor at Winckworth Sherwood, said the latest advice seems to suggest that long Covid should be treated as a disability by employers in order to avoid falling foul of discrimination legislation. She said her practice has seen cases of people with long Covid being treated poorly by bosses who failed to make adjustments allowing them to carry on working. Although some campaign groups and bodies, including the TUC, have called for long Covid to be recognised as a disability under the Equality Act, this has not yet happened. The Equality and Human Rights Commission (EHRC) has acknowledged that the short amount of time that long Covid has been in existence as a condition, and the fluctuating nature of symptoms, may be a barrier to the Government doing so, Ms Traczyk said.
16th May 2022 - iNews

EC to terminate Covid-19 vaccine deal with Valneva

The European Commission (EC) has informed Valneva of its plan to terminate the advance purchase agreement (APA) for the latter’s inactivated whole-virus Covid-19 vaccine candidate, VLA2001. The details were communicated by the EC through a notice to the company. An adjuvanted vaccine candidate, VLA2001 is for active immunisation of at-risk people to avert carriage and symptomatic Covid-19 infection. It comprises inactivated whole virus particles of the SARS-CoV-2 virus with increased S-protein density and two adjuvants, alum and Dynavax Technologies’ CpG 1018.
16th May 2022 - Pharmaceutical Technology

Pfizer, BioNTech amend Covid-19 vaccine supply deal with EC

Pfizer and BioNTech have amended the supply agreement with the European Commission (EC) to rephase the delivery schedules of their Covid-19 vaccine. The Pfizer-BioNTech COVID-19 Vaccine is based on the messenger ribonucleic acid (mRNA) technology of BioNTech. Under the deal, the initial contractual supply schedules for the vaccine will be updated to rephase the supplies to support the vaccination programmes of EC and its member states.
16th May 2022 - Pharmaceutical Technology

Covid-19 news: Just 7 per cent of 5 to 11-year-olds in England jabbed

Six weeks into the vaccine roll-out for this age group, fewer than one in 10 children aged 5 to 11 have received their first dose. The 7 per cent figure compares with the 24 per cent of 12 to 15-year-olds in England who received a first dose in the six weeks after they became eligible for the vaccine in September 2021. Children rarely become seriously ill with SARS-CoV-2 virus, however, testing positive can disrupt their schooling or put them at risk of long covid. Speaking of 5 to 11 year olds, Russell Viner at University College London told The Guardian: “It’s a vaccination that probably isn’t particularly beneficial for this age group. “However, it has a very, very good safety profile. And given that we remain in a pandemic, there’s an argument that for individual parents, the balance of risks would appear to be towards vaccination.”
16th May 2022 - New Scientist

Lacking vaccines, North Korea battles COVID with antibiotics, home remedies

Standing tall in bright red hazmat suits, five North Korean health workers stride towards an ambulance to do battle with a COVID-19 outbreak that - in the presumed absence of vaccines - the country is using antibiotics and home remedies to treat. The isolated state is one of only two countries yet to begin a vaccination campaign and, until last week, had insisted it was COVID-free. Now it is mobilizing forces including the army and a public information campaign to combat what authorities have acknowledged is an "explosive" outbreak.
16th May 2022 - Reuters

Valneva shares dive 20% after COVID vaccine deal with EU falls apart

Shares of Valneva plunged 20% on Monday after the French drugmaker said its COVID-19 vaccine agreement with the European Commission was being scrapped and it may have to rethink its financial guidance. Valneva said the European Commission had informed the company of its intent to terminate an advance purchase agreement (APA) for its COVID vaccine, which is currently under regulatory review by the European health regulator.
16th May 2022 - Reuters

FDA Authorizes Nonprescription Test for Covid-19, Flu and RSV

The Food and Drug Administration authorized the first nonprescription test that can detect Covid-19, influenza and respiratory syncytial virus, or RSV. The test, developed by Laboratory Corporation of America Holdings, can be sold directly to consumers online or at retail. A person can collect a nasal-swab sample themselves before sending the sample to Labcorp for analysis. The test, called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, searches for and amplifies the genetic materials of multiple viruses to figure out which one a person might be harboring.
16th May 2022 - The Wall Street Journal

Long Covid Symptoms Often Include Crushing Fatigue. Here’s How to Cope.

New studies offer clues about who may be more susceptible to long Covid, a term for lingering Covid-19 symptoms. WSJ breaks down the science of long Covid and the state of treatment
16th May 2022 - The Wall Street Journal

Valneva says European Commission to terminate purchase agreement for its VLA2001 COVID candidate

Valneva said on Monday it had received a notice of intent from the European Commission (EC) to terminate the advance purchase agreement for its VLA2001 COVID-19 candidate vaccine. "The EC decision is regrettable especially as we continue to receive messages from Europeans who are looking for a more traditional vaccine solution," CEO Thomas Lingelbach said. Valneva's vaccine relies on technology that has been used for decades, including in some shots against polio, influenza and hepatitis. Valneva signed a deal with the EC last November to supply up to 60 million doses of vaccine over two years, including 24.3 million doses in 2022.
16th May 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th May 2022

View this newsletter in full

How Omicron Infection Turbo-Charges Vaccinated People's Immunity

People who are vaccinated and then get infected with omicron may be primed to overcome a broad range of coronavirus variants, early research suggests. A pair of studies showed that infection produced even better immune responses than a booster shot in vaccinated patients. Teams from Covid-19 vaccine maker BioNTech SE and the University of Washington posted the results on preprint server bioRxiv in recent weeks. The findings offer a reassuring sign that the millions of vaccinated people who’ve caught omicron probably won’t become seriously ill from another variant soon -- even though the research needs to be confirmed, especially by real-world evidence.
15th May 2022 - Bloomberg

mRNA booster vaccines may be a good investment in developing countries

Vaccines based on inactivated SARS-CoV-2 virus are commonly used in developing countries due to their low cost. New research from Karolinska Institutet in Sweden shows that a booster shot of mRNA vaccine to individuals who have received two doses of inactivated vaccine offers the same level of protection against COVID-19 as three doses of mRNA vaccine. The findings are published in the journal Nature Communications. “Our results indicate that one booster shot of an mRNA vaccine, as a complement to the cheaper but less effective inactivated vaccines, is sufficient to achieve the ‘gold-standard’ immune response measured after three doses of mRNA vaccine,” says Qiang Pan Hammarström, professor at the Department of Biosciences and Nutrition, Karolinska Institutet, who led the study. “That would likely be a good investment even in resource-poor countries to protect against severe COVID-19.”
13th May 2022 - EurekAlert

Study shows how MS patients treated with Rituximab react to COVID-19 vaccination

MS patients treated with Rituximab have better responses to the COVID-19 vaccine if they have higher B cell counts. This is the finding of a study from Uppsala University published in the journal JAMA Network Open. In patients with B cell counts of 40/µL (microlitres) or more, 9 of 10 patients developed protective levels of antibodies, while significantly fewer with lower counts had similar responses. In Sweden, Rituximab is the most common medicine for multiple sclerosis (MS), but it is also used for many other diseases. The medicine is given as a drip, normally once or twice a year, and has a documented good effect on slowing the progression of MS. The treatment knocks out the body's B cells, which are an important part of our immune system though they also contribute to the MS disease process. As a result, the treatment increases the risk of patients suffering from serious infections, such as COVID-19. Having low levels of B cells also makes it more difficult for the body to form protective antibodies against viruses and bacteria, which is the primary purpose of vaccinations. In this case, this concerns the S protein in the SARS-CoV-19 virus.
13th May 2022 - News-Medical.Net

Covid-19 patent lawsuits: Will vaccine producers have to pay the bill?

In a new chapter with emerging legal dimensions for the Covid-19 vaccine success story, last week Moderna submitted a filing to take down a patent infringement lawsuit over its Covid-19 vaccine. In a claim filed on 28 February, Arbutus Biopharma and Genevant Sciences stated that Moderna infringed on their patented lipid nanoparticle (LNP) technology, and as such, were due damages from Moderna. Later in March, Pfizer’s Canada-based LNP partner Acuitas Therapeutics filed a complaint against Arbutus and Genevant in the US district court for the southern district of New York, asking for a judgement on the non-infringement and invalidity of such patents.
13th May 2022 - Pharmaceutical Technology

How China’s drive to develop its own state-of-the-art Covid vaccine is going

China has yet to approve any mRNA vaccines, which have the highest efficacy rates, despite the recent surge in cases in Shanghai. The authorities have not explained the delay, even though Fosun Pharmaceuticals has a commercial deal to distribute 100 million doses of BioNTech’s vaccine. Many analysts believe the authorities are waiting for a home-grown mRNA vaccine to be developed. Here is what we know so far about that quest.
13th May 2022 - South China Morning Post

The Next Big COVID-Vaccine Gamble

Up here in the Northern Hemisphere, the spring weather’s just barely warming, but regulators in the United States are already wringing their hands over a tricksy fall brew: the contents of the COVID shot that vaccine makers are prepping for autumn, when all eligible Americans may be asked to dose up yet again (if, that is, Congress coughs up the money to actually buy the vaccines). In a recent advisory meeting convened by the FDA, Peter Marks, the director of the agency’s Center of Biologics Evaluation and Research, acknowledged the “very compressed time frame” in which experts will need to finalize the inoculation’s ingredients—probably, he said, by the end of June. Which is, for the record, right around the corner. A big choice is looming. And whatever version of the virus that scientists select for America’s next jab is “probably going to be the wrong one,” says Allie Greaney, who studies the push and pull between viruses and the immune system at the University of Washington and the Fred Hutchinson Cancer Center.
13th May 2022 - The Atlantic

Novavax confident Covid vaccine will receive FDA authorization in June after delays

Novavax executives said this week that they’re confident the Food and Drug Administration’s advisory committee will recommend the shot for use in the adult population. If the FDA committee endorses the shot in June, the drug regulator is almost certain to rapidly authorize it for use in the U.S. CCO John Trizzino said Novavax also aims to have an updated shot that targets omicron ready for October should the U.S. decide to redesign the vaccines for a fall vaccination campaign.
13th May 2022 - CNBC

How air pollution can affect covid-19 risks

Research has shown that being unvaccinated raises a person’s risk of becoming infected with the coronavirus, while being older, overweight or immunocompromised can increase the severity of the disease. Now scientists think there is another risk factor that may increase the likelihood of contracting the coronavirus and the possibility that it will lead to a poor outcome: exposure to air pollution. A growing body of evidence suggests links between breathing polluted air and the chances of being infected by the coronavirus, developing a severe illness or dying of covid-19. While many of these studies focused on long-term exposure to air pollution, experts say there is also building evidence that even short-term exposures may have negative effects.
13th May 2022 - The Washington Post

COVID-19: Around 60,000 NHS workers living with PTS after battling the pandemic

An estimated 60,000 NHS workers are believed to be living with post-traumatic stress as a result of the COVID-19 pandemic, according to new research. NHS Charities Together also found nine in 10 workers (90%) say it will take them years to recover. Meanwhile, nearly three-quarters (73%) have expressed concerns about their colleagues leaving the workforce due to poor mental health. Neal Ashurst, an operating department practitioner, was redeployed during the pandemic, switching from anaesthetics to a critical care unit.
13th May 2022 - Sky News

Generic drugmakers to sell Pfizer's Paxlovid for $25 or less in low-income countries

Several generic drugmakers that will produce versions of Pfizer's (PFE.N) COVID-19 antiviral treatment Paxlovid have agreed to sell the medicine in low- and middle-income countries for $25 a course or less, the Clinton Health Access Initiative (CHAI) said on Thursday. CHAI said it could not disclose the names of the manufacturers who have agreed to the price ceiling, because they are still in the early stage of product development and have not received regulatory approval.
13th May 2022 - Reuters

Symptoms linger two years for some; inflammatory protein patterns may provide long COVID clues

Half of the COVID-19 patients discharged from a Chinese hospital in early 2020 still have at least one symptom two years later, a new study shows. Overall, regardless of initial disease severity, the 2,469 COVID-19 survivors in the study had improvements in physical and mental health over time. Nearly 90% of those who were employed returned to their jobs within two years. But the survivors had a "remarkably" lower health status than the general population at two years, and their burden of symptoms from after-effects "remained fairly high," the researchers reported on Wednesday in The Lancet Respiratory Diseases. At two years, 55% still had at least one COVID-19 after-effect, according to the report.
13th May 2022 - Reuters

Switzerland authorizes Moderna's COVID vaccine for 6-11 year olds

Moderna Inc said Swiss drugs regulator Swissmedic had authorized the use of its COVID-19 vaccine for children aged 6 to 11 years. The approval is for the vaccine's two-dose series of 50 micro gram per dose, Moderna added.
13th May 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th May 2022

View this newsletter in full

New COVID sub-variant, dubbed BA.2.12.1, is rapidly becoming dominant in US

Like an eraser sweeping away a chalkboard, the new COVID subvariant, dubbed BA.2.12.1, is rapidly excising its predecessor's once-rapid spread. Currently, this new iteration is on track to outtake its predecessor in the omicron BA.2 lineage; notably, previous omicron lineages have dropped to zero in studied lab samples.
13th May 2022 - Salon

Symptoms linger two years for some; inflammatory protein patterns may provide long COVID clues

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. COVID-19 symptoms still afflict many two years later Half of the COVID-19 patients discharged from a Chinese hospital in early 2020 still have at least one symptom two years later, a new study shows. Overall, regardless of initial disease severity, the 2,469 COVID-19 survivors in the study had improvements in physical and mental health over time. Nearly 90% of those who were employed returned to their jobs within two years.
13th May 2022 - Reuters

COVID-19: Around 60,000 NHS workers living with PTSD after battling the pandemic

Volunteers receive first dose in clinical trial of Melbourne-made COVID-19 vaccines

Volunteers receive first dose in clinical trial of Melbourne-made COVID-19 vaccines Doses of two new Melbourne-made COVID-19 vaccines have been given to six Victorian volunteers.
12th May 2022 - Nine News Australia

More than half of early Covid-19 patients at one hospital had symptoms two years later, study finds

Even two years after their initial infection, the majority of people who were hospitalized with Covid-19 early in the pandemic had lingering symptoms, according to a new study that may be one of the longest and largest on record to follow people with long Covid. The study, published Wednesday in The Lancet, found that 55% of patients still had at least one Covid-19 symptom two years later. That was actually an improvement from six months after infection, when 68% had symptoms.
12th May 2022 - CNN

Researchers recommend kidney transplant recipients continue getting COVID-19 vaccinations

Although COVID-19 vaccines lower the risk of infection among kidney transplant recipients, breakthrough infections can occur, and researchers recommend patients continue to receive boosters when available. “The SARS-CoV-2 messenger RNA (mRNA) vaccines have shown high clinical efficacy in preventing COVID-19 in the immunocompetent population,” Ivan Zahradka, MD, from the Institute for Clinical and Experimental Medicine in the Czech Republic, and colleagues wrote. They added, “However, data about the effectiveness of SARS-CoV-2 vaccines are conflicting, and to what extent the two doses of an mRNA vaccine protect [kidney transplant recipients] KTRs from COVID-19 is unclear.”
12th May 2022 - Healio

COVID-19 jabs still necessary, says Serbian epidemiologist

An increase in the number of new COVID-19 cases was not registered during the Labour Day and Easter holidays but everyone should be careful, and vaccinations are still necessary, said Serbian epidemiologist Predrag Kon on Tuesday. In a statement to Serbian public broadcaster RTS, Kon said that with the summer holidays approaching, people would be travelling to and from Serbia, which would increase the potential of spreading the virus. “We are in the situation where we should be extremely strongly recommending vaccination as half of the population has not been inoculated,” Kon stressed, noting that there was much higher vaccine uptake in cities than in rural areas.
12th May 2022 - EURACTIV

Study finds cancer patients with COVID-19 at greater risk of hospitalisation and death

Cancer patients with COVID-19 have a greater risk of both hospitalisation and death following infection compared with those without the disease Cancer patients with COVID-19 have been found to be at a greater risk of hospitalisation and 30-day all-cause mortality compared to those without the disease according to the results of a study by a US team from Texas. The presence of cancer has become a recognised factor that is associated with a higher risk for severe outcomes in those infected with COVID-19 and which is largely due to the presence of a compromised immune system. During the early course of the pandemic, studies observed that a higher proportion of cancer patients infected with COVID-19 were both hospitalised and subsequently died, compared to those without the disease.
12th May 2022 - Hospital Healthcare Europe

Covid-19 inquiry to look at impact of pandemic on mental health and young people

A public inquiry into the Covid-19 pandemic and its handling will now include the impact of the pandemic on mental health, and on children and young people. It will also look into collaboration between the central government and regional government, including devolved administrations. The chairwoman of the inquiry has also proposed changes to also look at support for victims of domestic abuse, first contact with the NHS, including 111 and 999 services, care in the home, and regulatory control. The updated remit was confirmed in the updated terms of reference published today.
12th May 2022 - Metro.co.uk

Moderna completes FDA submission for use of COVID shot in adolescents, kids

Moderna Inc has made all necessary submissions required by the U.S. Food & Drug Administration for emergency use authorization of its COVID-19 vaccine in adolescents and children, it said on Wednesday. The company is seeking approval for the use of its vaccines in three distinct age groups - adolescents aged 12 to 17 years, children aged six to 11 and those between six years and six months. The submissions for all three groups were made on May 9, it said.
12th May 2022 - Reuters

South African firm says it may close its COVID vaccine plant

The first factory to produce COVID-19 vaccines in Africa says it has not received enough orders and may stop production within weeks, in what a senior World Health Organization official described Thursday as a “failure” in efforts to achieve vaccine equity. South Africa’s Aspen Pharmacare said that it cannot let its large-scale sterile manufacturing facilities sit idle, and will return instead to making anesthetics. At the outset of the COVID pandemic, the company shifted its production and achieved capacity to produce more than 200 million doses annually of the one-shot Johnson & Johnson vaccine. “It was widely hailed as a great achievement for Africa, a game-changer for the continent. But it has not been followed up with orders. We have not received any orders from the big multilateral agencies,” Stavros Nicolaou, senior executive for strategic trade development at Aspen Pharmacare, told The Associated Press Thursday.
12th May 2022 - The Associated Press

Severe COVID, similar illnesses may raise risk for psychiatric disorders

A new study shows that the more than 32,000 survivors of severe COVID-19 and more than 16,000 survivors of other severe respiratory infections studied in England were at significantly higher risk than the general population for new anxiety disorders, dementia, psychosis, bipolar disorder, and new neuropsychiatric drug prescriptions in the first year after hospital release. In the observational study, published today in JAMA Psychiatry, a team led by University of Oxford researchers analyzed data from all 8.38 million adults registered in national databases from Jan 24, 2020, to Jul 7, 2021.
11th May 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th May 2022

View this newsletter in full

Covid: EU lifts face mask requirement for air travel as pandemic ebbs

The European Union will no longer require masks to be worn at airports and on planes starting next week amid the easing of coronavirus restrictions across the bloc, authorities said.
12th May 2022 - The Scotsman

India records single-day rise of 2,897 cases; UP death registrations fell in pandemic year

India records single-day rise of 2,897 Covid-19 cases With 2,897 coronavirus infections being reported in a day, India’s tally of cases rose to 4,31,10,586, even as active cases have decreased to 19,494, according to Union health ministry data updated on Tuesday. The death toll has climbed to 5,24,157 with 54 fatalities, the data updated at 8 am stated. The active cases comprise 0.05 per cent of the total infections, while the national Covid-19 recovery rate has been recorded at 98.74 per cent, it said. The data showed that a decrease of 143 cases has been recorded in the active caseload in a span of 24 hours. While the trend of increasing registrations of deaths in India continued in 2020 as well, Uttar Pradesh, the country’s most populous state, saw a big drop, despite the fact that the total number of deaths would probably have risen due to the Covid-19 pandemic. According to data from the Civil Registration System (CRS), Uttar Pradesh registered 8.73 lakh deaths in 2020, down from 9.44 lakh deaths registered in 2019.
12th May 2022 - The Indian Express

API and University of Waterloo to develop coronavirus drugs

Applied Pharmaceutical Innovation (API) and a team of researchers from the University of Waterloo in Canada have collaborated on the development of potential therapies and drugs to prevent and treat coronaviruses. The alliance will carry out research to develop potent small molecule therapies that can act on a protease enzyme essential for viral replication machinery in coronaviruses. This team of industry specialists and researchers focuses on designing structure-based solutions against a wide spectrum of coronavirus variants that will aid in alleviating any pandemic caused by such viruses in the future.
12th May 2022 - Pharmaceutical Technology

Coronavirus 'ghosts' found lingering in the gut

In the chaos of the first months of the coronavirus pandemic, oncologist and geneticist Ami Bhatt was intrigued by widespread reports of vomiting and diarrhoea in people infected with SARS-CoV-2. “At that time, this was thought to be a respiratory virus,” she says. Bhatt and her colleagues, curious about a possible link between the virus and the gastrointestinal symptoms, began to collect stool samples from people with COVID-19. Thousands of miles away from Bhatt’s lab at Stanford Medicine in California, gastroenterology internist Timon Adolph was puzzled by accounts of gut symptoms in infected people. Adolph and his colleagues at the Medical University of Innsbruck in Austria started to assemble specimens, too — gastrointestinal-tissue biopsies.
12th May 2022 - Nature.com

Fourth Covid-19 vaccine provides stronger immunity than third dose, study reveals

A fourth Covid-19 vaccine offers stronger immunity protection, a recent study has found. The latest results from the Cov-boost trial, which ran at University Hospitals Sussex NHS Foundation Trust, show that a fourth dose is “safe and boosts antibody levels - higher than that of a third dose”. A fourth dose of the vaccine has been offered as a spring booster to the most vulnerable people in the UK as a precautionary strategy.
12th May 2022 - The Argus

First real-world data from Africa on immune response to AZ/Oxford COVID-19 vaccine

Scientists have released the first real-world data from Africa on the effectiveness of two doses of AstraZeneca/ChaAd0x-1 COVID-19 vaccination, showing that while protective against SARS-CoV-2, immunity against the delta and omicron variants was lower, even in the context of prior infection or infection after vaccination. In a pre-print—which has yet to be peer-reviewed—scientists from Nigeria and the U.K. analyzed data from 140 healthcare workers at the Nigerian Institute of Medical Research and Federal Medical Center, Ebute Metta, and two private hospitals in Lagos. All participants had received two doses of the AstraZeneca vaccine administered between Jan and July 2021, with 12 weeks between doses.
11th May 2022 - Medical Xpress

Coronavirus pill: Researchers develop COVID-19 vaccine pill, protects against disease and transmission

An investigational COVID vaccine designed to be taken orally has been found not only to protect the host, but also to decrease the airborne transmission of the virus to the unvaccinated people. The pill-based COVID vaccine has shown promise in preliminary trials - both helping to protect against severe infections and reduce transmission in hamsters. Dr Langel and colleagues experimented with a vaccine candidate that uses an adenovirus as a vector to express the spike protein that SARS-CoV-2 uses to gain access to cells. Adenoviruses are a broad family of some 50 viruses known to cause a wide variety of illnesses such as the common cold, conjunctivitis, gastroenteritis, bladder infection, life-threatening multi-organ diseases in the clinically vulnerable. The team developed both intranasal and oral formulations of their vaccine candidate and tested it on hamsters. An advantage of the latter is that it is easy to administer.
11th May 2022 - Times of India

Emergent destroyed up to 400M COVID-19 vaccines, far more than previously known: report

Emergent's manufacturing setbacks forced the company to toss vaccine materials equivalent to nearly 400 million doses, according to a Tuesday report from the House of Representatives' Select Subcommittee on the Coronavirus Crisis. That's much more than the 85 million doses the company and U.S. officials previously disclosed, The Wall Street Journal reports. The report says Emergent had to toss 240 million doses in late 2020 and early 2021—before its COVID vaccine production issues became public knowledge. After Emergent's production pause in April 2021 through July 2021, the company tossed another 90 million doses. Expirations have forced the company to discard another 60 million doses, the report says.
11th May 2022 - FiercePharma

Inovio to discontinue COVID vaccine trial, appoints Jacqueline Shea as CEO

Inovio Pharmaceuticals Inc will discontinue a late-stage study of its COVID-19 vaccine, the company said on Tuesday, and appointed its operating chief as the new chief executive, sending the company's shares down nearly 20% after the bell. The decision on the trial comes after emerging global data showed a lower incidence of severe COVID cases, which would lead to an increase in trial size and costs, the company said.
11th May 2022 - Reuters

Shanghai firm says affiliate carrying out checks after COVID test accuracy questioned

Shanghai Runda Medical Technology said it has ordered its COVID testing affiliate to carry out checks after Shanghai residents whose samples were processed by the lab questioned the accuracy of results. Residents in the Chinese economic hub have over the past six weeks had to undergo multiple rounds of self-testing via antigen kits, as well as PCR tests, during the city's lockdown as China tries to curb COVID-19 transmission
11th May 2022 - Reuters

Explainer: Some patients reporting COVID rebounds after taking Pfizer pills

More than 2.8 million courses of Pfizer Inc’s (PFE.N) COVID-19 oral antiviral treatment Paxlovid have been made available at pharmacies around the United States, with the Biden administration working to improve access to the drug. As Paxlovid has become more widely used, some patients have reported that COVID-19 symptoms recurred after completing treatment and experiencing improvement. Here is the latest information on these rebounds:
11th May 2022 - Reuters

WHO calls on Pfizer to make its COVID pill more available

The head of the World Health Organization called on Pfizer to make its COVID-19 treatment more widely available in poorer countries, saying Tuesday that the pharmaceutical company’s deal allowing generic producers to make the drug was insufficient. WHO Director-General Tedros Adhanom Ghebreyesus said during a news briefing that Pfizer’s treatment was still too expensive. He noted that most countries in Latin America had no access to Pfizer’s drug, Paxlovid, which has been shown to cut the risk of COVID-19 hospitalization or death by up to 90%. “We remain concerned that low- and middle-income countries remain unable to access antivirals,” Tedros said, The WHO chief warned that the unequal distribution of COVID-19 drugs could ultimately mirror the grossly disproportionate distribution of coronavirus vaccines.
10th May 2022 - The Associated Press

The ‘five pandemics’ driving 1 million U.S. Covid deaths

Officially, the U.S. will almost certainly reach an awful milestone in the next two weeks: its one millionth recorded Covid-19 death. In reality, this milestone was likely unofficially crossed days or weeks ago, and we’ll never know the exact toll or the identity of the pandemic’s actual millionth victim. Nor are humans well-equipped to fully grasp loss on this scale, let alone the magnitude of a global toll estimated to be as high as 14.9 million. One way to start understanding how a country as advanced as the U.S. lost so many people is to look at the ocean of public health data that was gathered as 1 million individual tragedies rippled through civic life.
10th May 2022 - STAT News

Telehealth aims to crack open Paxlovid’s prescription bottleneck

After months of shortages, pharmacies across the United States are being stocked with drugs to treat Covid-19. Now, the bottleneck has shifted to getting a prescription — and patients and public health agencies are looking to telehealth for help. Last week, Massachusetts launched free televisits for state residents who have tested positive for Covid-19, including home delivery of Paxlovid, Pfizer’s oral antiviral, if prescribed. New York City has filled more than 16,000 courses of the drug through its home delivery program, 2,100 of which started with a free telehealth visit with NYC Health + Hospitals. And a growing number of virtual care companies are promoting televisits as a first-line resource for patients who have tested positive, advertising against Google searches for “Paxlovid” and partnering with testing companies that route patients to their providers.
10th May 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th May 2022

View this newsletter in full

Covid vaccines are ‘safe for pregnant women and cut stillbirth risk’, study says

Covid-19 vaccines are safe for pregnant women to take and can even reduce the risk of stillbirths, according to a new study. Researchers at St George’s University of London and the Royal College of Obstetricians and Gynaecologists collated data from studies and trials involving over 115,000 vaccinated pregnant women.
10th May 2022 - The Independent

Israeli study shows importance of COVID boosters, lacking in much of the world

With much of the world still lacking COVID boosters, a large new Israeli study has underscored the urgency of rolling out third vaccine doses. The peer-reviewed research shows that both the quantity and quality of antibodies skyrocket after a third dose of Pfizer’s vaccine. While the study has limited relevance in Israel and other Western countries where third doses were given long ago, it has broad global significance. Worldwide, only 24 boosters have been given per 100 people — with a disproportionate number in rich countries. Across Africa, only 1.6 boosters have been given per 100 people; in India where boosters only became available last month the figure is 2; and in Russia it is 9.7, even though in all these places there are lots of people who had their initial vaccination shots long ago.
10th May 2022 - The Times of Israel

Moderna mounts defense in COVID-19 vaccine patent feud with Arbutus, Genevant

In its COVID-19 vaccine patent kerfuffle with Arbutus Biopharma and Roivant’s Genevant Sciences, mRNA hot shot Moderna aims to shield itself with its government contract, court documents filed Friday show. Plaintiffs Arbutus and Genevant sued Moderna back in February, seeking damages tied to six patents they claim Moderna infringed with the production and sale of its COVID-19 vaccine Spikevax. In its new response, Moderna said it plans to show that Spikevax doesn’t tread on any valid patents, including those held by the plaintiffs Arbutus and Genevant. But the company says "that dispute is for later." The immediate problem is that the plaintiffs should have sued the U.S. government instead, Moderna said in a filing at the U.S. District Court for Delaware. To back up its argument, Moderna cited a federal law once used to “’prevent patent infringement suits from interfering with the supply of war materials during World War 1.'
10th May 2022 - FiercePharma

Exploring simultaneous and sequential COVID-19 vaccine candidate

In a recent study posted to the bioRxiv* pre-print server, researchers developed novel lipid nanoparticle (LNP)-based messenger ribonucleic acid (mRNA) vaccine formulations against three pathogenic coronaviruses (CoVs), including SARS, Middle Eastern respiratory syndrome-CoV (MERS-CoV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
10th May 2022 - News-Medical.Net

Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says

Emergent BioSolutions, a longtime government contractor hired to produce hundreds of millions of coronavirus vaccine doses, hid evidence of quality control problems from Food and Drug Administration inspectors in February 2021 — six weeks before it alerted federal officials that 15 million doses had been contaminated. The disclosure came in a report released Tuesday by House Democrats, who said that all told, nearly 400 million doses of coronavirus vaccine manufactured by Emergent had to be destroyed “due to poor quality control.” Previous estimates of lost vaccine were far lower; no contaminated doses were ever released to the public. The report, issued jointly by the House Committee on Oversight and Reform and the Select Subcommittee on the Coronavirus Crisis, is the product of an investigation that began last year, after The New York Times documented months of problems at Emergent’s troubled Bayview plant in Baltimore.
10th May 2022 - The New York Times

Emergent BioSolutions discarded ingredients for 400 million COVID-19 vaccines, probe finds

Between March 2020 and February 2022, vaccine-maker Emergent BioSolutions was forced to discard or destroy up to 400 million doses' worth of the key component of both Johnson & Johnson's and AstraZeneca's coronavirus vaccine due to quality-control issues, according to a congressional report published Tuesday -- a figure that reflects more than five times what was previously disclosed by the beleaguered firm. Problems included the contamination of vaccine ingredients, as well as equipment failures and employee errors, the report said. Congressional investigators probing the Maryland-based biotech company found that Emergent executives had privately raised urgent quality-control concerns even before the company began manufacturing the vaccines' key ingredient -- despite publicly expressing confidence in their ability to deliver on their multimillion-dollar government contract.
10th May 2022 - ABC News

Spatial and temporal fluctuations in COVID-19 fatality rates in Brazilian hospitals

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Gamma variant of concern has spread rapidly across Brazil since late 2020, causing substantial infection and death waves. Here we used individual-level patient records after hospitalization with suspected or confirmed coronavirus disease 2019 (COVID-19) between 20 January 2020 and 26 July 2021 to document temporary, sweeping shocks in hospital fatality rates that followed the spread of Gamma across 14 state capitals, during which typically more than half of hospitalized patients aged 70 years and older died. We show that such extensive shocks in COVID-19 in-hospital fatality rates also existed before the detection of Gamma. Using a Bayesian fatality rate model, we found that the geographic and temporal fluctuations in Brazil’s COVID-19 in-hospital fatality rates were primarily associated with geographic inequities and shortages in healthcare capacity. We estimate that approximately half of the COVID-19 deaths in hospitals in the 14 cities could have been avoided without pre-pandemic geographic inequities and without pandemic healthcare pressure. Our results suggest that investments in healthcare resources, healthcare optimization and pandemic preparedness are critical to minimize population-wide mortality and morbidity caused by highly transmissible and deadly pathogens such as SARS-CoV-2, especially in low- and middle-income countries.
10th May 2022 - Nature.com

Evasion of COVID-19 vaccine-medicated mucosal immunity by SARS-CoV-2 Omicron

NELF was carefully collected using hydroxylated polyvinyl acetate (PVA) sponges. These sponges were inserted within the inferior turbinate and the nasal septum and left in situ for approximately 15 minutes till they swelled, then softly withdrawn and kept in a 50 ml Falcon tube with 2 ml of saline solution. Simple pressure was used to remove the fluid (nasal secretions+saline) from the sponge, which was then aliquoted and stored at -70°C for further examination. The VPLEX® SARS-CoV-2 Panel was used to assess IgG and IgA targeting the S of the SARS-CoV-2 Omicron, Delta variants, and ancestor strain. Further, the V-PLEX® Isotyping Panel 1 Human/NHP Kit was used to determine total IgG and IgA levels. Nasal secretions were diluted 10-time before being tested for S-specific and overall IgG and IgA. The V-PLEX® Sector Imager 2400 plate reader was used to collect data, which was then processed using Discovery Workbench 3.0 software. The ability of NELF antibodies to hinder the adherence of a soluble ACE2 to S of the SARS-CoV-2 Omicron, Delta variants, and the ancestral strain was tested by the multiplex V-PLEX® SARS-CoV-2 Panel 13 ACE2 Kit. Before assessing for binding attenuation, NELF was diluted 10-time. As mentioned above, the data was collected and analyzed using the V-PLEX® Sector Imager 2400 plate reader and the Discovery Workbench 3·0 software, respectively.
10th May 2022 - News-Medical.net

Covid-19: Fourth dose of mRNA vaccines is safe and boosts immunity, study finds

Fourth doses of covid-19 mRNA vaccines are safe and provide a substantial boost to antibody concentrations and cellular immunity when given more than six months after a third dose of Pfizer’s vaccine, a study has found. The latest findings from the UK Cov-Boost study, published in Lancet Infectious Diseases,1 compared antibody and T cell responses after a fourth dose of an mRNA covid-19 vaccine with immune responses after a third dose. Giving a fourth dose of Pfizer’s and a half dose of Moderna’s vaccine was effective at increasing antibody levels and cellular immunity up to and above the baseline and peak levels seen after third dose boosters, the results show. Although pain at the vaccination site and fatigue were the commonest side effects, there were no vaccine related serious adverse events, and the fourth doses were safe and well tolerated, the authors said. Some study participants maintained high antibody levels and cellular responses even before the fourth dose and had limited boosting from a fourth dose. Researchers said this trend was also noted in participants with previous infection, which indicated that a fourth dose may not boost immunity if baseline levels are high.
10th May 2022 - The BMJ

Novavax shares slide 20% on COVID vaccine demand uncertainty

Novavax Inc's shares plunged nearly 20% in premarket trading on Tuesday due to uncertainty over global demand for the company's COVID-19 vaccine following a slow start to deliveries. The company said in September it had targeted for the delivery of at least 2 billion doses of its COVID-19 vaccine in 2022. Novavax said on Monday it delivered about 42 million doses globally in the first quarter. Serum Institute of India, the world's biggest vaccine maker, also produces the company's COVID-19 vaccine under the brand name Covovax.
10th May 2022 - Reuters

Texas doctor calls U.S. COVID deaths nearing 1 million 'mindblowing'

In the early days of the COVID-19 pandemic, pulmonologist Joseph Varon offered an opinion that made headlines around the world and went viral on social media. He was fighting two wars, he said: one against COVID and one against stupidity. As the United States nears the grim milestone of 1 million coronavirus-linked deaths, Varon, chief of critical care and COVID-19 at United Memorial Medical Center in Houston, Texas said only one of those battles has been won. “I think that I have won the fight against the coronavirus. I think I've lost the fight against human stupidity,” Varon told Reuters.
10th May 2022 - Reuters

BioNTech completes Phase II trial of COVID-19 vaccine in China

Vaccine developer BioNTech completed a Phase II clinical trial of its COVID-19 vaccine in China in January but has yet to release its results, a registry of such trials showed on Tuesday. The vaccine, based on messenger RNA (mRNA) technology, is one of the most widely used worldwide against COVID, but has yet to receive approval in China, which has vaccinated 89% of its 1.4 billion population with several domestically developed non-mRNA shots. China's leading medical experts have urged authorities to retain tough zero-COVID measures to buy time, step up vaccination rates and develop new treatments in the battle against the country' biggest outbreak.
10th May 2022 - Reuters

Rare cases of COVID returning pose questions for Pfizer pill

As more doctors prescribe Pfizer’s powerful COVID-19 pill, new questions are emerging about its performance, including why a small number of patients appear to relapse after taking the drug. Paxlovid has become the go-to option against COVID-19 because of its at-home convenience and impressive results in heading off severe disease. The U.S. government has spent more than $10 billion to purchase enough pills to treat 20 million people. But experts say there is still much to be learned about the drug, which was authorized in December for adults at high risk of severe COVID-19 based on a study in which 1,000 adults received the medication.
10th May 2022 - Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th May 2022

View this newsletter in full

Cancer diagnosis a year before infection not linked to worse outcomes; air travel carries COVID risks

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Old cancer diagnosis not linked with worse COVID-19 outcomes. Patients diagnosed with cancer more than a year before contracting COVID-19 and those not receiving active treatment may be no more vulnerable to worse COVID outcomes than those without cancer, according to a new study.
9th May 2022 - Reuters

FDA sets limits on the use of the Janssen COVID-19 vaccine in US

The FDA has limited the authorized use of the Janssen COVID-19 vaccine to individuals 18 years of age and older who cannot access other approved COVID-19 shots for various reasons.
9th May 2022 - biopharma-reporter

ZF2001 vaccine safe and effective against symptomatic and severe-to-critical COVID

Preliminary preclinical studies of the ZF2001 vaccine using rodents and macaques revealed promising efficacy against SARS-CoV-2. Additionally, the phase 1 and 2 clinical trials also reported the vaccine to be safe and effective in humans. Scientists designed a three-dose regimen in the phase 3 trial of ZF2001. A new study published in the New England Journal of Medicine has discussed the efficacy and safety profile of the ZF2001 vaccine in adults, based on a randomized, placebo-controlled, multinational, double-blind phase 3 trial. During this study, the SARS-CoV-2 Delta variant was dominantly circulating globally.
9th May 2022 - News-Medical.Net

Vaccine to stop Covid transmission should now be top priority, says leading UK scientist

It is questionable how much longer current Covid-19 vaccines will be used as they have largely done their job in preventing mass deaths, and scientists should focus on developing a vaccine that stops transmission of the virus, according to leading scientist Sir John Bell. The huge success of Covid vaccines in countries able to get them has led to sharp declines in deaths and severe disease from the virus, even though the latest Covid variant, Omicron, has spread rapidly. “We need a new vaccine to stop transmissions and there are lots of interesting ideas,” said Bell, regius professor of medicine at Oxford University and a former member of the UK vaccine taskforce who has worked on the Oxford/AstraZeneca Covid jab.
9th May 2022 - The Guardian

Nasal vaccines may be the next generation of protection against COVID

Current vaccines are great at stopping severe disease. But people can still catch COVID-19, even after two, three or more shots. Researchers hope a different delivery system will make for a vaccine that is better at preventing transmission and infections. By putting the vaccine directly into the nose, it might prevent the virus from taking hold in the mucus membranes, where it first enters the body. Studies are still underway to prove whether this approach will work. And even if it does, the vaccines are likely to take another year to become widely available.
9th May 2022 - USA TODAY

Knowledge about COVID-19, vaccination influences vaccine uptake in pregnancy

Pregnant patients who had more knowledge about COVID-19 and immunization were more likely to get vaccinated against SARS-CoV-2, according to a study presented here. However, researchers emphasized that it is also incumbent on providers to improve vaccine uptake and increase acceptance. While Eva Agasse acknowledged that informing patients is vital to encourage vaccination, how clinicians present themselves is also important.
9th May 2022 - Healio

Oral COVID-19 Vaccine Protects Host, Slows Transmission in Hamsters

The available COVID-19 vaccines have been called the biggest scientific accomplishment of the century and a modern miracle. But that hasn’t stopped scientists from working on making improvements. To that end, a new study presents promising data on a COVID-19 vaccine that is designed to be taken as a pill. Moreover, the vaccine not only protects the host, but also decreases the airborne spread of the virus to other close contacts. The experiments, done in a hamster model that mimics human exposures, demonstrated the potential of a COVID vaccine that works through the mucosal tissue to neutralize the SARS-CoV-2 virus, limiting infections and the spread of active virus in airborne particles.
9th May 2022 - Genetic Engineering & Biotechnology News

COVID-19’s hidden, heartbreaking toll: millions of orphaned children

The World Health Organisation estimates that as of May 5, nearly 15 million people have died of causes related to COVID-19 since the global pandemic hit—almost three times the official death toll. In the United States, the country that has recorded the most deaths, nearly one million Americans have died, according to data compiled by Johns Hopkins. Hidden behind those statistics is an orphanhood crisis unprecedented in modern history. Nearly 10.4 million children worldwide have lost a parent or caregiver to COVID-19, according to latest estimates from Imperial College London. In the worst affected country by number of cases and deaths – the U.S. – more than 214,000 children have lost a parent or caregiver. Like the death toll itself, the true numbers are likely higher.
9th May 2022 - National Geographic UK

How Hong Kong's vaccination missteps led to the world's highest covid-19 death rate

Hong Kong’s strict guidelines on social distancing and its restrictions on travel ensured months of low infection rates for covid-19, until the omicron variant hit the city in February 2022. Before that, Hong Kong had reported 212 deaths related to covid-19; around 9000 people have since died from the virus in the city’s fifth wave of infection. As of late April, more than 70% of deaths were in patients aged 80 or older, 73% of whom were unvaccinated. The hospital system has been overwhelmed, with patients occupying hospital beds in parking lots, bodies kept in hospital corridors and in patient rooms, and morgues overflowing. This is despite vaccines being readily available in the city since February 2021. Hong Kong had procured enough doses of the Pfizer and Sinovac vaccines for its population of seven million, and both vaccines were made available at community vaccination centres and private clinics across the city within weeks of the rollout. Older citizens were given priority access to vaccination.
9th May 2022 - The BMJ

Study investigates the cause of lymphopenia as seen in COVID-19 patients

In a recent study posted to the Research Square preprint server, researchers explored the underlying mechanism resulting in thymic atrophy and subsequent lymphopenia in coronavirus disease 2019 (COVID-19) patients. Previous studies have reported dysregulated T cell function and lymphopenia in COVID-19 patients. However, the literature does not shed light on immunological and pathological alterations in thymus post-severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection.
9th May 2022 - News-Medical.Net

COVID vaccine makers shift focus to boosters

COVID-19 vaccine makers are shifting gears and planning for a smaller, more competitive booster shot market after delivering as many doses as fast as they could over the last 18 months. Executives at the biggest COVID vaccine makers including Pfizer and Moderna said they believe most people who wanted to get vaccinated against COVID have already done so - more than 5 billion people worldwide. In the coming year, most COVID vaccinations will be booster shots, or first inoculations for children, which are still gaining regulatory approvals around the world, they said.
9th May 2022 - Reuters

BioNTech trumpets strong sales, but pandemic 'uncertainty' still suggests a decline in 2022

Omicron-fueled vaccine orders propelled Pfizer’s COVID-19 partner BioNTech to record sales in 2022’s first quarter, but the German mRNA specialist still expects sales to fall this year compared with 2021. Chalk it up to the uncertainty of the pandemic’s trajectory and now, a war in Ukraine, BioNTech executives said on a call with analysts. Despite a strong start to the year, the company must "acknowledge the uncertainty derived from the course of the pandemic and the political uncertainties of recent months,” Jens Holstein, BioNTech’s chief financial officer, said
9th May 2022 - Fierce Pharma

3 COVID vaccine doses appear to protect against Omicron subvariants

Three new studies report on COVID-19 vaccine effectiveness (VE) and antibody responses to Omicron, with one from Sweden finding a drop in two-dose VE against severe disease after the transition from the BA.1 to the BA.2 subvariant but three-dose protection remaining above 80% against severe disease. Also, a study from Hong Kong shows good antibody response against BA.2 after three doses, and one from the United States finds that nursing home patients who received a third dose had a 47% lower risk of Omicron infection.
6th May 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th May 2022

View this newsletter in full

The lucky few to never get coronavirus could teach us more about it

When her partner tested positive for the coronavirus two days before Christmas, Michelle Green worried she, too, would become ill. She was two months pregnant with their second child. He was a bartender at the time, and some of his co-workers were infected with the virus. “I told him to get in the guest bedroom and don’t leave,” said Green, a 40-year-old project manager at a retail technology start-up in the District. The couple, who were both vaccinated, and their toddler postponed their Christmas celebration. Somehow, Green never tested positive. Scientists around the world are investigating how a dwindling number of people such as Green have managed to dodge the coronavirus for more than two years, even after the highly transmissible omicron variant drove a record-shattering surge in cases this winter.
9th May 2022 - The Washington Post

Cognitive impairment from long COVID equivalent to aging 20 years, study finds

A new study says that cognitive impairment due to long COVID is the equivalent of aging 20 years or losing 10 IQ points. Researchers from the University of Cambridge and Imperial College London published their findings in the journal eClinicalMedicine last week. They looked at data from 46 individuals who received care at a hospital for COVID-19 between March and July 2020 and compared them to a matched control group. Six months after their stay in hospital, the researchers invited the patients and the control group to undergo a computerized test to measure their memory, attention and reasoning. The researchers found that compared to the control group, those who had been hospitalized with COVID-19 were less accurate and displayed slower response times in the test.
9th May 2022 - CTV News

Cognitive Impairment From Severe COVID-19 Equivalent to 20 Years of Aging – Losing 10 IQ Points

Cognitive impairment as a result of severe COVID-19 is similar to that sustained between 50 and 70 years of age and is the equivalent to losing 10 IQ points, say a team of scientists from the University of Cambridge and Imperial College London. The findings, published recently in the journal eClinicalMedicine, emerge from the National Institute for Health and Care Research (NIHR) COVID-19 BioResource. The results of the study suggest the effects are still detectable more than six months after the acute illness, and that any recovery is at best gradual.
9th May 2022 - SciTechDaily

Surviving the pandemic is only half the battle: ‘Long COVID’ could affect a billion in just a few years

The COVID death rate is a shadow of its former self, and more than two years into the pandemic, Americans seem to be breathing a sigh of relief—thanks to vaccines, their risk of death or hospitalization from the virus is greatly diminished. But there’s more to take into account before ditching your mask, experts say—Long COVID, a new chronic condition defined by an array of symptoms that endure long after the initial COVID infection has cleared. Long COVID may already affect between 7 and 23 million Americans who previously had the virus, or up to 7% of the U.S. population, according to the U.S. Government Accountability Office.
8th May 2022 - Fortune

Shanghai's life-saving efforts against the current omicron wave of the COVID-19 pandemic

In late February, 2022, a wave of SARS-CoV-2 infection rapidly appeared in Shanghai, China. According to the Shanghai Municipal Health Commission, as of May 4, 2022, 601 942 cases have been identified, including 547 056 asymptomatic carriers. 503 people have died with or from COVID-19. Phylogenetic features of SARS-CoV-2 viral genomes from 129 patients in this period, and inferring their relationship with those available on the GISAID database, indicated that all of the new viral genomes in Shanghai were clustered into the SARS-CoV-2 BA.2.2 sub-lineage. Of note, BA.2 is a sub-lineage of the omicron variant of SARS-CoV-2 (B.1.1.159). Multiple sub-lineages of BA.2 have been characterised, many of which appear to show distinct regional distribution patterns.
7th May 2022 - The Lancet

They Got Covid on Purpose To Help Scientists Learn More About It

Jacob Hopkins, 24, tried hard not to get Covid-19 in the months leading up to March 2021, when, if he succeeded, he could be part of a unique experiment in which he was deliberately infected with the virus. Almost a year earlier, he had put his name on a list of volunteers. Months went by until, on Dec. 23, he finally heard back from someone associated with the experiment. He ended up being the very first volunteer given the infection — patient 1. As he described it to me, he took a cab to a hospital in London, wearing a mask so he would be sure not to catch Covid at the last minute. He arrived on a Friday, went through a battery of tests over two days, and on Monday, five health-care workers came in wearing full PPE, “like something out of the movie ‘Contagion,’” pulling in a tank of solution containing SARS-CoV-2.
7th May 2022 - Bloomberg

South Africa Covid-19 Test Positivity Rate Nears Record

South Africa’s daily coronavirus test positivity rate neared a record, rising above 30% on Saturday for the first time in almost five months as two sublineages of the omicron variant spread rapidly ahead of the nation’s winter season. There were 8,524 new Covid-19 cases identified, representing a 31.1% positivity rate of those tested, the National Institute for Communicable Diseases said in a statement on its website. That’s the highest rate since the 32.2% recorded on Dec. 15, when a record 26,976 cases were recorded.
7th May 2022 - Bloomberg

Kids get limited COVID protection from world's most popular vaccines

Three new studies offer a first look at how well some of the most widely used COVID-19 vaccines protect young children from the coronavirus1–3. The results — including data from toddlers as young as three years old — have prompted mixed responses among researchers about whether the vaccines should be recommended for use in kids. The research examines two ‘inactivated’ vaccines, which rely on whole viruses that have been killed, that were developed by Chinese scientists. The results, from Argentina, Brazil and Chile, show that, in children, the vaccines provide little protection against SARS-CoV-2 infection and modest protection against symptomatic COVID-19. The studies also show that the vaccines are less effective against the now-dominant Omicron variant than the earlier Delta variant. The studies have not yet been peer reviewed.
6th May 2022 - Nature.com

Healthy young people in UK may never be offered another Covid jab, says expert

Healthy younger people in the UK may never be offered another Covid jab, a leading expert has said, as a new wave of infections is expected to hit the country in the coming weeks. Giving his personal expert opinion, Adam Finn, a professor of paediatrics at the University of Bristol and a member of the UK’s Joint Committee on Vaccination and Immunisation, suggested there was little point in offering a fourth jab to those yet to pass middle age, at least in the current landscape. “I think it’s questionable whether young, healthy people will ever be offered another Covid vaccine beyond dose three – at least with the vaccines and variants we have now,” Finn said, although he added both could change.
6th May 2022 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th May 2022

View this newsletter in full

Medicago announces publication of Phase 3 COVID-19 vaccine study results in New England Journal of Medicine

Medicago today announced the publication of the results from the Phase 3 study of COVIFENZ®, COVID-19 Vaccine (plant-based virus-like particles [VLP], recombinant, adjuvanted), in the New England Journal of Medicine (NEJM). The Phase 3 trial studied the two-dose regimen of COVIFENZ® given 21 days apart versus placebo in over 24,000 subjects aged 18 and above. Common side effects in the vaccine group included injection site pain, headache, fatigue, fever, muscle aches, and chills. COVIFENZ® is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 to 64 years of age. The safety and efficacy of COVIFENZ® in individuals younger than 18 years of age or 65 years and older have not been established. COVIFENZ® has not yet received approval in other jurisdictions. “We are proud to have our Phase 3 clinical trial published in the esteemed New England Journal of Medicine to be shared with the larger scientific community
5th May 2022 - PharmiWeb

Plant-based COVID-19 vaccine grown inside Australian native shows 'promising results'

A plant-based coronavirus vaccine grown inside a native Australian plant related to tobacco is showing promising results against the virus, which has claimed more than six million lives globally. The vaccine, known as CoVLP+AS03 and developed by Medicago, has been approved in Canada for people who are 18 to 64 years of age. So, how does it work? Scientists insert bacteria containing the virus' genetic code into the plant Nicotiana benthamian. The plant then starts developing its own coronavirus-like particles or CoVLP. These are extracted and combined with an immune-boosting additive, known as an adjuvant, in the final vaccine, called CoVLP+AS03.
5th May 2022 - 9News

Novavax seeks expanded authorisation for Covid-19 vaccine in Great Britain

Novavax has sought expansion of the authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents of the age 12 to 17 years in Great Britain. The recombinant, adjuvanted vaccine is intended for active immunisation to prevent Covid-19 in adolescents of this age group. In February this year, the vaccine obtained conditional marketing authorization (CMA) from MHRA for use in people aged 18 years and above. The vaccine is administered in two doses at a gap of 21 days as the initial vaccination regimen. This CMA expansion request is based on the entirety of pre-clinical, clinical and manufacturing-related (CMC) data submitted to the regulatory authority.
5th May 2022 - Pharmaceutical Technology

Are nasal sprays the answer to stopping Covid transmission?

The roaring success of Covid vaccines – in countries able to obtain them – has led to deaths and severe disease from the infection plummeting even as the virus evolved to sidestep immunity and rip through populations more swiftly. But while the rapid development of Covid shots ranks as the finest achievement of the pandemic, scientists are not done yet. In a small number of labs around the world, teams are taking on a problem that cannot be ignored: that the virus remains rampant in the face of mass immunity. The problem has arisen because existing Covid vaccines are better at preparing the immune system to fight the virus inside the body than stopping it at the gates. So even though immunity has largely “defanged” Covid, countries still face waves of infection that hospitalise vulnerable people, keep staff off work, and leave an uncertain proportion of people with long Covid.
5th May 2022 - The Guardian

WHO Says 15 Million Have Died From Covid-19 Pandemic

The World Health Organization estimated that nearly 15 million people had died from causes related to the coronavirus pandemic by the end of 2021, putting the toll from Covid-19 at nearly three times the number that had been officially recorded by countries. India suffered the highest toll of any country in the world, according to the report released Thursday, but most of the deaths have gone unrecorded. The 4.7 million people who had died in India by the end of last year, according to WHO estimates, was nearly 10 times the official tally at that time of 481,000 deaths. India’s count has risen to about 524,000 since then. The report, which was compiled by scientists from around the world, has sparked fierce resistance from India, where government officials have denounced the health agency’s methodology and objected to the release of the report.
5th May 2022 - The Wall Street Journal

FDA rebukes Pfizer CEO's suggestion to take more Paxlovid if COVID-19 symptoms return

The FDA rebuked Pfizer CEO Albert Bourla’s proposed solution to reports that some patients experienced a relapse of COVID-19 symptoms after treatment with the company's antiviral Paxlovid. After reports said some patients who took Paxlovid rebounded and started feeling symptoms again, the CEO told Bloomberg that patients can take another course, “like you do with antibiotics.” “Paxlovid does what it has to do: It reduces the viral load,” Bourla, Ph.D., told Bloomberg in an interview. “Then your body is supposed to do the job.” The FDA isn't on board with the suggestion. “There is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course,” John Farley, M.D., director of the Office of Infectious Diseases, said in a post.
5th May 2022 - FiercePharma

Omicron just as deadly as earlier Covid variants, Harvard scientists claim

The Omicron variant of Covid-19 is just as potent as other variants that came before it, according to a new study in the US. The study, which has yet to be peer-reviewed, would bring into question the widespread public perception that Omicron — while more transmissible — results in less severe symptoms and fewer hospitalisations. Researchers assessed the records of 130,000 Covid patients in the past two years, spanning periods when different variants were dominant across the world. "We found that the risks of hospitalisation and mortality were nearly identical between periods," said the four scientists, three of whom are based at Harvard Medical School in Massachusetts. The study, titled “Sars-Cov-2 Omicron Variant is as deadly as previous waves after adjusting for vaccinations, demographics and comorbidities”, was published on Research Square on 2 May.
5th May 2022 - The Independent

Does the World Still Need New Covid-19 Vaccines?

Our mandate remains to develop the best tools to prevent the emergence of new variants of concern and control the health and socioeconomic fallout from new surges. The decision by representatives of the African region to establish a network of six mRNA technology hubs10 is a sign that countries and regions are motivated to build local and regional capacity and expand self-sufficiency not only in planning and participating in key clinical trials but also in designing and manufacturing vaccines to better meet the needs of their populations during pandemic threats. Such technology hubs will need to embrace technologies beyond the mRNA approach.
5th May 2022 - Nejm.org

Doctors investigating why some report rebound in COVID-19 symptoms after Paxlovid

When Laura Martin tested positive for COVID-19 last month during an extended stay in California, she was prescribed Paxlovid, the highly touted antiviral drug created by Pfizer. Just one day after her diagnosis, she started her five-day course of pills, which have been shown to dramatically reduce the risk of hospitalization and death. Martin, a 63-year-old Boston native who now resides in Canada, said she was thrilled when her symptoms began to subside. “By the end of [the treatment], on Day 5, I was negative and feeling completely normal like without any symptoms, so I thought, 'Wow, this is really great. What a great drug,’” Martin told ABC News.
5th May 2022 - ABC News

EMA says it hopes to approve Covid variant-adapted vaccines by autumn

The European Union's drug regulator said on Thursday it hoped to have vaccines adapted to address coronavirus variants, such as Omicron, approved by September. "Our priority is to ensure that adaptive vaccines are possibly approved by September at the latest to be ready for the rollout of new immunisation campaigns in the EU in the autumn," said Marco Cavaleri, head of biological health threats and vaccines strategy at the European Medicines Agency (EMA)
5th May 2022 - Reuters

Omicron as severe as previous COVID variants, large study finds

The Omicron variant of the SARS-CoV2 virus is intrinsically as severe as previous variants, according to a preprint version of a large U.S. study that counters assumptions in other studies that it was more transmissible but less severe. The findings, which estimated Omicron's severity after accounting for the impact of vaccines, should reinforce the importance of inoculations and booster shots, experts said. Vaccines helped keep hospitalizations and deaths relatively low during the Omicron surge compared with previous variants.
5th May 2022 - Reuters

WHO: Nearly 15 million deaths associated with COVID-19

The World Health Organization estimates that nearly 15 million people were killed either by coronavirus or by its impact on overwhelmed health systems during the first two years of the pandemic, more than double the current official death toll of over 6 million. Most of the deaths occurred in Southeast Asia, Europe and the Americas, according to a WHO report issued Thursday. The U.N. health agency’s director-general, Tedros Adhanom Ghebreyesus, described the newly calculated figure as “sobering,” saying it should prompt countries to invest more in their capacities to quell future health emergencies. WHO tasked scientists with determining the actual number of COVID-19 deaths between January 2020 and the end of last year.
5th May 2022 - The Associated Press

Evidence mounts for need to study Pfizer's Paxlovid for long COVID - researchers say

Additional reports of patients with long COVID who were helped by Pfizer Inc's oral antiviral treatment Paxlovid offer fresh impetus for conducting clinical trials to test the medicine for the debilitating condition, U.S. researchers said on Thursday. Three new case studies follow earlier reports of long COVID patients who experienced relief of their symptoms after taking the treatment, which is currently only authorized for high-risk people early after onset of COVID symptoms.
5th May 2022 - Reuters

Moderna tunes booster pitch ahead of potential shift to private COVID vaccine market this fall

To boost or not to boost, that is the question. The answer, according to executives at mRNA expert Moderna, is a resounding yes. The meteoric rise and fall of the SARS-CoV-2 omicron variant this past winter “continues to demonstrate the remarkable evolutionary capacity of this virus,” Paul Burton, M.D., Ph.D., Moderna’s chief medical officer, said on the company’s earnings call Wednesday. “The slowing of booster uptake now means there will be individuals who are under-vaccinated and under-protected as we move into late spring and summer, when we thought we would have declining case counts,” the biotech’s top scientist added. With COVID-19's infectious potential considered, the company is arguing for a "variant adapted booster campaign this coming fall," Burton said.
4th May 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th May 2022

View this newsletter in full

Valneva to launch trial for booster use of its COVID-19 vaccine candidate

French drugmaker Valneva said on Wednesday it will conduct a trial about the use of its COVID-19 vaccine candidate VLA2001 as a booster jab following a mRNA vaccination or natural infection.
4th May 2022 - Reuters

Moderna sees higher COVID vaccine sales later this year

Moderna Inc on Wednesday forecast higher vaccine sales for the second half of the year than in the first six months, as it expects the virus that causes COVID-19 to follow a more seasonal pattern requiring booster shots in the fall.
4th May 2022 - Reuters

Long Covid in Kids Has Effects That Last Beyond Hospital

As the world pretends the pandemic is over, at least a half-million children in the U.S. are struggling with the mysterious disease.
4th May 2022 - Bloomberg

Severe Covid May Lower Survivor's IQ By 10 Points, Study Finds

Severe Covid-19 may cause long-lasting cognitive impairment, similar to how much brainpower 70-year-olds typically have lost compared to age 50, a new study found, adding to preliminary evidence that infections may inhibit survivors’ intellectual capabilities. The study of 46 patients, who were assessed six to ten months after being hospitalized, showed slower and less accurate responses than what was expected for their age and demographic profile. Those patients who required ventilators and organ support scored even worse. The effect was sudden, as it was the equivalent of aging 20 years intellectually within the span of a few months. The impairment is equivalent to losing about 10 IQ points, said co-author Adam Hampshire, a professor of restorative neurosciences at Imperial College London, in an interview.
4th May 2022 - Bloomberg

Covid 19 Omicron outbreak: Siouxsie Wiles - what we know about BA.4 and BA.5 variants

BA.4 and BA.5 are responsible for a new wave of Covid-19 cases in South Africa. At least one of them has arrived on our shores. So what does the science tell us about these new Omicron variants? While most countries are winding down their testing and sequencing efforts, South Africa has been doing an absolutely stellar job of detecting new Covid-19 virus variants. It was the country that first identified the three original Omicron lineages (BA.1, BA.2, and BA.3) back in November last year. Once other countries started to look, they found Omicron everywhere. BA.1 started the initial global Omicron wave, followed by the more infectious BA.2. In South Africa they only had one large BA.1 wave. Here in New Zealand, BA.1 and BA.2 arrived and seeded into the community very close together, so we had both at the same time – though BA.2 became the dominant lineage. BA.3 never really took off anywhere.
4th May 2022 - New Zealand Herald

Taiwan records first death of someone in their 20s from COVID-19

A woman in her 20s with no known underlying medical conditions died of COVID-19 this week despite being vaccinated with a booster, according to the Central Epidemic Command Center (CECC) Wednesday. The woman is the first person in their 20s to die from the disease in Taiwan since the beginning of the pandemic. Lo Yi-chun (羅一鈞), a CECC official and Centers for Disease Control deputy director-general, said at a daily press briefing that the woman, who had been vaccinated with three doses of a COVID-19 vaccine, first displayed symptoms of fever and diarrhea on April 26. Her rapid test was positive that day and she took a PCR that evening with the results coming back the next day, confirming her to be positive, Lo said, adding that she then went into home quarantine.
4th May 2022 - Focus Taiwan News Channel

Three new Covid Omicron subvariants detected in Australia

Three new Omicron subvariants have reached Australia and health authorities say people who contract the virus should wait three months before getting their next Covid-19 vaccination. Assoc Prof Stuart Turville from the University of New South Wales’ Kirby Institute says Omicron subvariants BA.2.12.1, BA.4 and BA.5 have been detected in the country. Authorities are warning this winter season is likely to see a spike in Covid-19 cases and flu as restrictions which have suppressed the circulation of both viruses are phased out.
4th May 2022 - The Guardian

Newer, fitter descendants of Omicron variant begin to drive their own coronavirus waves

Average daily hospitalizations are up about 10% since last week, according to data collected by the US Department of Health and Human Services. The culprit this time appears to be a spinoff of Omicron's BA.2 subvariant called BA.2.12.1, which was first flagged by New York state health officials in April. BA.2.12.1, which is growing about 25% faster than its parent virus, BA.2, accounts for nearly 37% all Covid-19 cases across the US, according to new estimates from the CDC. BA.2 caused an estimated 62% of all Covid-19 cases last week, down from 70% the week before.
4th May 2022 - CNN

Covid-19 worsens asthma in children, finds study

The study, published in the journal Frontiers in Cardiovascular Medicine , looked at almost 49,000 unvaccinated patients in total, and identified multiple predictors of more severe Covid-19 and worse outcomes in them compared to vaccinated individuals. It found that evidence of heart muscle damage (myocardial injury) at the time of admission to hospital was associated with a nine-fold increase in likelihood of death. Patients found to have such heart issues also had higher chances of developing other complications, including severe lung failure (acute respiratory distress syndrome) and acute kidney injury, and required higher rates of intensive care admission and invasive mechanical ventilation.
4th May 2022 - India Today

Unvaccinated individuals with heart problems up to 9 times more likely to die or suffer serious complications from COVID-19

Researchers from Queen Mary University of London have combined evidence from 110 previous Covid-19 studies and found that unvaccinated individuals who contract the virus when they already have high blood pressure, diabetes or major heart damage are up to nine times more likely to suffer serious outcomes - including death, lung failure, admission to intensive care and kidney problems.
4th May 2022 - QMUL

Covid-19: Remdesivir has “small effect” against death or progression to ventilation, WHO trial finds

Remdesivir has no significant effect on patients with covid-19 who are already being ventilated but has a small effect against death or progression to ventilation among other patients admitted to hospital, the World Health Organization’s Solidarity trial has found.1 This appears to be a change from findings reported in February 2021, when preliminary trial data suggested that remdesivir “had little or no effect on patients admitted to hospital with covid-19.”2 The Solidarity trial recruited over 14 000 patients from 454 hospitals across 35 countries between March 2020 and January 2021, of which over 8000 were allocated 1:1 to remdesivir (10 daily infusions) or control (no drug). The updated results, published in the Lancet, reported that overall 14.5% (602 of 4146) of patients assigned to remdesivir died compared with 15.6% (643 of 4129) assigned to the control group (mortality rate ratio 0.91, 95% confidence interval 0.82 to 1.02, P=0.12).
4th May 2022 - The BMJ

Lasting brain impacts of severe COVID-19 equivalent to 20 years of ageing

The lasting mental impacts of severe COVID-19 on areas like memory, attention, or problem solving, may be equivalent to 20 years of ageing. These are the findings of a new study, led by a team of scientists from the University of Cambridge and Imperial College London, which suggest that cognitive impairment as a result of severe COVID-19 is similar to that sustained between 50 and 70 years of age and is the equivalent to losing 10 IQ points. The research, published in the journal eClinicalMedicine, indicates the effects are still detectable more than six months after acute illness and that any recovery is at best gradual. According to the researchers, this is the first time that such rigorous assessment and comparison has been carried out in relation to the after-effects of severe COVID-19.
4th May 2022 - Imperial College London

Patterns in Olfactory Injury Among Patients Who Died From COVID-19

Article reports that among patients who died with COVID-19 infection, more severe axon pathology, axon losses, and microvasculopathy were found in the olfactory tissue than in those who died without COVID-19 infection, suggesting COVID-19 olfactory dysfunction may be permanent. These are the findings of a postmortem study published in JAMA Neurology. SARS-CoV-2 is associated with a range of symptoms with the most common nonrespiratory symptom presenting as olfactory dysfunction. As the pandemic is still recent, it remains unclear how long COVID-19 symptoms may persist.
4th May 2022 - Neurology Advisor

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th May 2022

View this newsletter in full

Pfizer maintains sales forecasts for its COVID-19 vaccine, pill in sign that demand has slowed

Pfizer Inc's increase maintained its sales forecasts for its pandemic products on Tuesday after a series of hikes to revenue projections for its COVID-19 vaccine last year, in a sign that dizzying growth has slowed. Several countries have eased pandemic restrictions, relaxing rules on masking and quarantines, even as cases rise in some regions. The company said it expects $22-billion in sales from its COVID-19 treatment Paxlovid this year, compared with analysts’ average expectation of $26.1-billion, according to Refinitiv. Pfizer had previously said its $22-billion forecast for sales of the pills only represents a fraction of the 120 million courses the company is able to manufacture this year.
3rd May 2022 - The Globe and Mail

Moderna COVID vaccine may have slight edge over Pfizer in infections only

Relative to the Pfizer/BioNTech COVID-19 vaccine, the Moderna version confers slightly more protection against infection—but not hospitalization, intensive care unit (ICU) admissions, or death—90 days after the second dose, suggests a modeling study of more than 3.5 million fully vaccinated Americans published today in Nature Communications. Optum Labs scientists in Minnesota compared the effectiveness of the Moderna and Pfizer COVID-19 vaccines by analyzing healthcare claims from fully vaccinated Americans insured by a single US insurer (Medicare Advantage and commercial insurance). Among 8,848 infected participants, 35% had received the Moderna vaccine, and 65% had received Pfizer. Follow-up was 14 to 151 days after the second vaccine dose. The researchers also analyzed data from those younger and older than 65 years who had never been infected.
3rd May 2022 - CIDRAP

Effectiveness of ChAdOx1-S COVID-19 booster vaccine

In the present study, researchers estimated the ChAdOx1-S booster vaccine effectiveness (VE) against SARS-CoV-2 symptomatic disease and related hospitalization post-infection with the SARS-CoV-2 Delta or Omicron variants. A negative case-control design was employed to estimate the VE of the ChAdOx1-S booster vaccine. The team compared the likelihood of vaccination in symptomatic polymerase chain reaction (PCR) positive cases to that in symptomatic individuals who tested SARS-CoV-2 negative. Data related to all positive PCR and liver function tests (LFTs) and negative PCR tests were obtained from symptomatic persons with a diagnosis reported between 25 November 2020 and 17 February 2022. For individuals who reported more than one negative test result, one was selected for further analysis.
3rd May 2022 - News-Medical.Net

Nose Spray Vaccines Could Quash COVID Virus Variants

The relentless evolution of the COVID-causing coronavirus has taken a bit of the shine off the vaccines developed during the first year of the pandemic. Versions of the virus that now dominate circulation—Omicron and its subvariants—are more transmissible and adept at evading the body’s immune defenses than its original form. The current shots to the arm can still prevent serious illness, but their ability to ward off infection completely has been diminished. And part of the reason may be the location of the jabs, which some scientists now want to change. To block infections entirely, scientists want to deliver inoculations to the site where the virus first makes contact: the nose. People could simply spray the vaccines up their nostrils at home, making the preparation much easier to administer.
3rd May 2022 - Scientific American

Pfizer accused of Covid profiteering as first-quarter sales hit $26bn

Pfizer has made nearly $26bn (£21bn) in revenues in the first three months of the year, the bulk from its Covid-19 vaccine and new pill to treat the virus, prompting fresh accusations of pandemic profiteering. Covid vaccines have saved many lives around the world and relieved the pressure on health systems, but Pfizer has faced criticism over its vaccine pricing and its refusal to waive patent protection to enable others to make the jab. Last week 35 campaigners from Global Justice Now, Act-Up London, Just Treatment and Stop Aids protested against what they call pandemic profiteering, and delivered wheelbarrows full of fake money to Pfizer’s UK headquarters in Surrey on the day of the company’s annual shareholder meeting.
3rd May 2022 - The Guardian

Pfizer Sales Soar on Covid-19 Vaccine Sales

Pfizer Inc. expects demand for its Covid-19 antiviral drug to increase as governments return to replenish their supplies and seek to thwart surges as the pandemic virus continues to evolve. The treatment, a pill called Paxlovid, brought in $1.5 billion in sales during Pfizer’s first quarter, while its vaccine totaled $13.2 billion, reflecting the need for tools to combat the virus despite a slowdown in cases and a growing sense of life trying to return to normal. The company said Tuesday it is on track to deliver between $98 billion and $102 billion in revenue for the year, with $32 billion coming from its Covid-19 vaccine Comirnaty and $22 billion from Paxlovid. “We remain bullish on Paxlovid” said Chief Financial Officer Frank D’Amelio on a call discussing earnings with analysts. “The rhythm of that product looks very good.”
3rd May 2022 - The Wall Street Journal

Most Americans have now had Covid-19 -- but experts are predicting the next surge

While it's tempting to say much of life is getting back to normal, it's probably more accurate to say it feels more comfortable and normal living alongside Covid-19. For many of those who are vaccinated or were previously infected, learning of a close contact with the disease is less frightening than frustrating.
3rd May 2022 - CNN

Covid-19 news: Cognitive impairment equivalent to 20 years of ageing

People hospitalised with covid-19 may lose 10 IQ points, equivalent to the natural cognitive decline that occurs between 50 and 70 years old. Covid-19 can cause lasting cognitive and mental health issues, including brain fog, fatigue and even post-traumatic stress disorder. To better understand the scale of the problem, researchers at the University of Cambridge analysed 46 people who were hospitalised due to the infection between March and July 2020. The participants underwent cognitive tests on average six months after their initial illness. These results were compared against those of more than 66,000 people from the general population.
3rd May 2022 - New Scientist

Pfizer keeps sales forecast for COVID-19 antiviral pill unchanged

Pfizer Inc maintained sales forecasts for its pandemic products on Tuesday after a series of hikes to revenue projections for its COVID-19 vaccine last year, in a sign that dizzying growth has slowed. Several countries have eased pandemic restrictions, relaxing rules on masking and quarantines, even as cases rise in some regions. The company said it expects $22 billion in sales from its COVID treatment Paxlovid this year, compared with analysts' average expectation of $26.1 billion, according to Refinitiv.
3rd May 2022 - Reuters

Pfizer sticks to 2022 sales forecasts for COVID pill, vaccine

More uniformly infectious, more treatable, more genetically predictable: How coronavirus is getting closer to flu

Hours after a federal judge struck down the federal mask mandate covering air travel and other public transportation last month, Delta Airlines celebrated the move in a statement saying that Covid-19 “has transitioned to an ordinary seasonal virus.” By the next day, after an intense backlash from public health experts, Delta had taken the offending language down. “‘Ordinary viruses don’t cause 1 million deaths in one country in just 2 years,” tweeted epidemiologist Jessica Malaty Rivera, a senior adviser at the Rockefeller Foundation’s Pandemic Prevention Institute. SARS-CoV-2 remains a long way from being ordinary. It has not yet found seasonal cadence — take the recent surge in Europe and the U.K., which comes just weeks after the initial Omicron wave subsided — and it’s still capable of inflicting mass death and disability (see Hong Kong’s lethal last few months).
3rd May 2022 - STAT News

Paxlovid’s failure as a preventative measure raises questions, but doctors still back it as a therapeutic

Pfizer released news late Friday that Paxlovid, the antiviral currently subject to a big push from the U.S. government, failed to prevent people living with Covid patients from catching the infection. The news is one of several bad headlines for the new Covid pill, but one experts say doesn’t affect the medicine’s primary use: treating people who are already sick. Paul Sax, clinical director of the division of infectious diseases at Brigham and Women’s Hospital, said he would “absolutely” prescribe Paxlovid to people at high risk of severe disease who have Covid. “Without hesitation,” he said. “Because the net benefit in the high risk study was extremely high.”
2nd May 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd May 2022

View this newsletter in full

Covid Testing Stations to Disappear in Oslo as City Moves On

Norway’s capital is gradually closing its municipal testing stations as it removes a general recommendation for the city’s residents to test for Covid-19. May 9 will be the last day that people can test at the public stations, the Oslo municipality said in a statement on its website. People wishing to get checked before traveling internationally will need to use private providers, it said. Norway ranked first for a second month in Bloomberg’s Covid Resilience Ranking in April. The Nordic nation is among a growing group that no longer have Covid-related travel curbs in place, and has even scrapped a requirement to self-isolate after a positive result.
2nd May 2022 - Bloomberg

Better Vaccines Are in Sight — for the Next Pandemic

Arcturus Therapeutics, a San Diego biotech company, may have just laid out a template for how to make vaccines for the next pandemic. Its new vaccine, which uses self-copying mRNA, appears to work well against current strains of Covid. It’s just that the product is coming in too late to matter in the current pandemic. But data from a large clinical trial suggest the technology should be explored for the next one — and it may have many other uses, too. In a study that enrolled more than 16,000 people, Arcturus’s “self-amplifying” mRNA vaccine was 95% protective against severe disease and death and about 55% effective in preventing symptomatic Covid.
2nd May 2022 - Bloomberg

Pfizer says COVID treatment Paxlovid fails to prevent infection of household members

Pfizer said a large trial found that its COVID-19 oral antiviral treatment Paxlovid was not effective at preventing coronavirus infection in people living with someone infected with the virus. The trial enrolled 3,000 adults who were household contacts exposed to an individual who was experiencing symptoms and had recently tested positive for COVID-19. They were either given Paxlovid for five or 10 days or a placebo.
2nd May 2022 - Reuters

South Africa's Aspen COVID-19 vaccine plant risks closure after no orders, executive says

Africa's first COVID-19 vaccination plant, touted last year as a trailblazer for an under-vaccinated continent frustrated by sluggish Western handouts, risks shutting down after receiving not a single order, a company executive said on Saturday. South Africa's Aspen Pharmacare negotiated a licensing deal in November to package and sell Johnson & Johnson's COVID-19 vaccine and distribute it across Africa. The World Health Organization (WHO) called the deal a "transformative moment" in the drive towards levelling stark inequalities in access to COVID vaccines.
2nd May 2022 - Reuters

Chinese Omicron-specific mRNA COVID vaccine candidate to be trialed in UAE

China's Suzhou Abogen Biosciences Co said its COVID-19 vaccine candidate using the messenger RNA (mRNA) technology and targeting the Omicron variant has obtained clinical trial approval in the United Arab Emirates. With Friday's announcement, Abogen joins Pfizer/BioNTech and Moderna in trialing candidates modified specifically against Omicron, a highly transmissible variant with increased resistance to antibodies elicited by existing shots.
1st May 2022 - Reuters

Pfizer’s Covid-19 Pill Failed Study Testing Its Preventive Use

The Covid-19 pill from Pfizer Inc. failed to prevent symptomatic infections in adults who had been exposed to the pandemic virus, a late-stage study found. Pfizer said Friday that the drug, named Paxlovid, failed the study’s main objective of meaningfully reducing the risk of confirmed and symptomatic Covid-19 infections in adults who were exposed to the virus by someone in their household. Paxlovid was cleared for use in December by U.S. health regulators to treat people 12 years and older early in the course of their disease who are at high risk of developing severe Covid-19.
30th Apr 2022 - The Wall Street Journal

Mystery Liver Disease: CDC Says Covid Not Cause of Pediatric Hepatitis Cases

U.S. health officials cast doubt on Covid-19 as a potential cause of severe hepatitis that’s been seen in dozens of previously healthy children around the world, while adding weight to the possibility it’s caused by a more common virus linked to stomach ailments. The Centers for Disease Control and Prevention on Friday released its most detailed report yet on nine cases of pediatric hepatitis in Alabama that have captured national attention. All the patients tested negative for Covid-19 at the hospital and had no documented history of infection with SARS-CoV-2, the report said. Covid has shown it can damage a variety of organs, including the liver, raising the possibility that it could be linked to the more than 160 worldwide cases seen so far of unexplained liver disease in children. U.K. experts said earlier this week that the condition might be connected to adenoviruses, a family of pathogens that more commonly cause cold and flu symptoms.
30th Apr 2022 - Bloomberg

U.S. Seeks 'Urgent' Data on Covid Relapses After Using Pfizer's Drug

U.S. government researchers are planning studies of how often and why coronavirus levels rebound in some Covid patients who have completed a five-day course of treatment with Pfizer Inc.’s Paxlovid. “It is a priority,” said Clifford Lane, deputy director for clinical research at the National Institute of Allergy and Infectious Diseases, calling the issue “a pretty urgent thing for us to get a handle on.” The agency is discussing a variety of possible epidemiological and clinical studies to examine post-Paxlovid rebound with scientists at the Centers for Disease Control and Prevention, he said. The demand for answers is rising as Paxlovid has become a key element of the Biden administration’s pandemic approach, with the drug being made available at pharmacies nationwide. Among other questions the NIH hopes to get a better handle on is how often viral rebounds occur after five days of Paxlovid treatment, who’s at risk for relapse, and whether it could be avoided with a longer regimen.
30th Apr 2022 - Bloomberg

Child hepatitis cases rise in UK amid worldwide outbreak

The UK Health Security Agency has identified 34 confirmed hepatitis cases in children since Monday, bringing the total number to 145 amid a series of unexplained cases among children around the world. The agency said 10 children had received liver transplants but nonehad died. Findings suggested that the rise in sudden cases in children may be linked to a common cold virus known as an adenovirus, the UKHSA said, adding that the agency was also investigating other possible infections, including COVID-19 or an environmental cause.
30th Apr 2022 - Reuters

Pfizer's Covid Drug Fails to Show Benefit as Preventive Therapy

The drug, Paxlovid, failed to meet its primary goal of significantly reducing the risk of Covid-19 infection in adults exposed to the virus through a household contact, Pfizer said in a statement Friday. The drug reduced risks by about a third compared with a placebo, which didn’t meet the threshold for statistical significance. Chief Executive Officer Albert Bourla said he was “disappointed” by the study results. Expanding Paxlovid’s use to people who hadn’t yet tested positive for Covid-19 but have had close contact with an infected person would have opened up a large potential new market for the drug. Paxlovid is already one of the fastest sellers of all-time in the pharmaceutical industry, with projected sales of almost $24 billion in 2022, according to a forecast from analytics group Airfinity Ltd. Shares of New York-based Pfizer fell as much as 3.9% in extended trading before paring declines.
29th Apr 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Apr 2022

View this newsletter in full

Merck quarterly profit tops expectations on demand for COVID pill, cancer drugs

Merck & Co posted better-than-expected first-quarter earnings and raised its full-year sales estimate on strength from its top-selling cancer drug Keytruda, human papillomavirus (HPV) vaccine Gardasil and its COVID-19 antiviral pill molnupiravir.
29th Apr 2022 - Reuters on MSN.com

Valneva awaits EU COVID-19 vaccine decision

Valneva remains optimistic that its COVID-19 vaccine could get the green light in the EU in the near future. On Monday, the French vaccine company announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has asked for additional data and further justification for a Conditional Marketing Authorization for the vaccine.
28th Apr 2022 - Biopharma-Reporter

Study shows public health impact of covid-19 vaccines in the U.S.

A large US study published by The BMJ today finds that fewer people die from covid-19 in better vaccinated communities. The findings, based on data across 2,558 counties in 48 US states, show that counties with high vaccine coverage had a more than 80% reduction in death rates compared with largely unvaccinated counties. This large benefit complements the growing body of evidence indicating individual level benefits of covid-19 vaccination. A linked editorial also proposes that encouraging people to keep up to date with vaccination saves lives. As of 11 April 2022, more than 11 billion covid-19 vaccine doses have been administered globally and the World Health Organization's target is to vaccinate 70% of the world's population by mid-2022.
28th Apr 2022 - News-Medical.Net

Covid-19: Highly vaccinated communities see far fewer deaths - study

High vaccination rates reduced Covid-19 deaths by more than 80% compared with places with low vaccine uptake, according to a major study of cases in the United States. The researchers, from the US Centers for Disease Control and Prevention (CDC), looked at infections of the Alpha and Delta strains, and deaths from these strains, across more than 2,500 US counties during 2021. They compared places where the number of adults who had received at least one dose of a Covid-19 vaccine was very low (<10%), low (10-39%), medium (40-69%), and high (>70%) and found as vaccine rate increased, death rates and infections from the virus fell away dramatically.
28th Apr 2022 - Stuff.co.nz

Measles cases surge nearly 80% in wake of Covid chaos, with fears other diseases could follow

In the short term, if the goal is to stop transmission when cases are rising and enhance society’s transition to more normal activities, boosters could conceivably help. “If you can quickly boost a bunch of people at the cusp of a surge, you might be able to flatten that curve,” Swift says. She notes, however, that boosters only temporarily slow the spread of infection. Adding to the public’s risk calculation fatigue, many airlines lifted mask requirements last week after a federal judge ruled that a mask mandate on public transportation is unlawful. (The Department of Justice has since appealed that ruling.) “It feels like a mixed message to people to say, ‘Get your booster but stop wearing masks,’” Swift says. “It’s been such a quagmire.”
28th Apr 2022 - The Guardian

Here’s Who Should Get a Second COVID Booster

Although the consensus remains that getting the initial full-series vaccination offers a clear benefit, scientists today disagree on the value of a fourth mRNA vaccine dose. Some say a second booster is essential for protecting highly vulnerable people—and that it should also be available to their families and other close contacts. Others note that the FDA’s decision about a fourth dose was based on limited evidence—primarily one study in Israel—and that the original two-shot series still provides durable protection against the most severe outcomes in adults with a healthy immune system. For its part, guidance published on April 6 by the European Center for Disease Prevention and Control and the European Medicines Agency’s COVID-19 Emergency Task Force states that a fourth mRNA COVID vaccine dose can be given to adults age 80 and older but that it is too early to consider that booster for the general population.
28th Apr 2022 - Scientific American

The future of vaccine research and learning the lessons of COVID-19

The global effort to produce a vaccine for COVID-19 has rightly been lauded as one of the greatest scientific achievements of the past century. The sheer speed at which the process moved from producing the first viral genetic sequence to global rollout of effective vaccines was all the more impressive when remembering that the fastest any vaccine had previously been developed was around four years, for mumps in the 1960s, and most vaccine production timescales had been a decade or more. A number of factors – including a wealth of funding, regulatory flexibility, and scientific expertise – were on our side, which is unsurprising given the matter that needed addressing was the worst global health crisis for a generation.
28th Apr 2022 - European Pharmaceutical Review

Merck Profit Boosted by Sales of Covid-19 Pill

Merck & Co. reported stronger-than-expected first-quarter profit and revenue and raised its full year outlook Thursday, buoyed by sales of its Covid-19 antiviral following the winter omicron wave. Merck reported $3.2 billion in revenue from its Covid antiviral, known as Lagevrio or molnupiravir, compared with Wall Street expectations of $2.72 billion. The drug was cleared by regulators in late 2021 so the first quarter is its first full quarter of sales. The company now expects overall full-year sales of $56.9 billion to $58.1 billion, up from a prior forecast that topped out at $57.6 billion. Adjusted 2022 earnings will be $7.24 to $7.36 a share, Merck said, up from a range of $7.12 to $7.27.
28th Apr 2022 - Bloomberg

The benefits of large scale covid-19 vaccination

New evidence confirms that fewer people die in better vaccinated communities - The first covid-19 vaccines were administered under emergency use authorisation in December 2020, just one year into the pandemic, a “miracle” of pharmaceutical innovation that has saved an estimated million lives or more in the US alone.12 The authorisation was given on the basis of safety and efficacy in randomised controlled trials, which found that immunisation with Pfizer-BioNTech and Moderna mRNA vaccines protected a remarkably high percentage (>90%) of recipients from developing symptomatic infection and, to a lesser extent, from asymptomatic infection too. In other words, when tested against the SARS-CoV-2 variants prevailing in 2020 and early 2021, these novel covid-19 vaccines could stop the great majority of infections from causing illness and help to prevent transmission of SARS-CoV-2. But could vaccination prevent infection and illness on a large scale, outside the controlled environment of clinical trials? A linked study by Suthar and colleagues (doi:10.1136/bmj-2021-069317) adds to the evidence that it can, across the US
28th Apr 2022 - The BMJ

WHO says pandemic justifies leader's pitch at Moderna meeting

A shareholder proposal calling on Moderna Inc to study transferring production of COVID-19 vaccines to less-developed countries won 24% support from investors on Thursday after it received a rare endorsement from the World Health Organization. Proponents say production shifts could help combat the global pandemic. Moderna of Cambridge, Mass. opposed the measure, saying among other things it already maximized its manufacturing capacity with partners, and that poorer countries have declined millions of doses that Moderna was prepared to deliver.
28th Apr 2022 - Reuters

Moderna files for U.S. authorization of COVID shot for kids under 6

Moderna Inc said it asked U.S. regulators to authorize its COVID-19 vaccine for children under the age of 6, which would make it the first shot against the coronavirus available for those under 5-years-old. The COVID-19 vaccine from Pfizer Inc and BioNTech SE is authorized for children 5 and older. But their trial results for 2- to 4-year-olds showed a weaker immune response than in adults, forcing the study to be extended to test a third dose. Pfizer has said that data would come in April.
28th Apr 2022 - Reuters

European studies shed light on long COVID risk and recovery

A trio of new observational studies from Europe describes long COVID prevalence in Luxembourg, the effect of initial infection severity on risk in Sweden, and an occupational therapy program to ease symptoms in Ireland. The research was presented at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Portugal, which ended yesterday.
28th Apr 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Apr 2022

View this newsletter in full

CDC Data Plan Is Too Vague, Lacks Deadlines, U.S. Watchdog Says

The U.S. Centers for Disease Control and Prevention’s plan to modernize its data operations is too vague, lacks deadlines and doesn’t assign clear responsibility for completing the project, a government watchdog said in a report. The CDC’s Data Modernization Initiative was launched in 2020 as part of a broader push to overhaul the country’s public health information systems and improve capacity to respond to threats like Covid-19. While the pandemic pushed some of those efforts into high speed, the Government Accountability Office report said that the agency’s overall plan “does not articulate the specific actions, time frames, and allocation of roles and responsibilities needed to achieve its objectives.” And while the CDC has been given $1.1 billion to move ahead with its data plans, the agency had yet to fully lay out plans for spending the money, according to the GAO, the investigational arm of Congress.
28th Apr 2022 - Bloomberg

Measles cases jump 79% in 2022 after COVID hit vaccination campaigns

Measles cases jumped by 79% in the first two months of this year compared to 2021, after COVID-19 and lockdowns disrupted child vaccination campaigns around the world, according to data from UNICEF and the World Health Organization (WHO). In January and February, there were 17,338 measles cases reported worldwide, up from 9,665 in the same period last year. Measles is a very contagious disease that can be particularly dangerous for young children and babies. It spreads more quickly than Ebola, flu or COVID-19.
28th Apr 2022 - Reuters

CIDRAP to develop vaccine roadmap for future coronavirus threats

New coronaviruses armed with the capacity to cause severe human disease are becoming more frequent, raising the stakes for global preparedness, along with a need for a vaccine that could broadly protect against the most dangerous ones, such as SARS-CoV-2. To help jump-start the process, the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota announced today that it has received $1 million in grants from the Rockefeller Foundation and the Bill & Melinda Gates Foundation to create a Coronavirus Vaccines Research and Development (R&D) Roadmap.
27th Apr 2022 - CIDRAP

Covid-19 cases that return after antiviral treatment puzzle doctors

The pink line on Erin Blakeney's first positive Covid-19 test was so light that she almost didn't believe it. But there was no denying the fever and sore throat that developed overnight, just a few days after she and her husband attended a large memorial service in late March. The couple wore KN95 masks, but many others in attendance had not, even as the service stretched past 90 minutes. Blakeney, a 43-year-old researcher at the University of Washington's School of Nursing, is a breast cancer survivor. The Seattle resident says she doesn't meet any strict definition of being immunocompromised, which can raise someone's Covid-19 risk. Both Blakeney and her husband are fully vaccinated and boosted. But she didn't want to take chances, because she's taking medications to prevent a cancer recurrence and she lost a family member to Covid-19 in November 2020.
27th Apr 2022 - CNN

More than half of Americans have had Covid, including three of four children

More than half of Americans show signs of a previous Covid-19 infection, including three out of every four children, according to a new report released on Tuesday. The findings from the Centers for Disease Control and Prevention (CDC) come after researchers examined blood samples from more than 200,000 Americans and looked for virus-fighting antibodies made from infections, not vaccines. They found that signs of past infection rose dramatically between December and February, when the more contagious Omicron variant surged through the US.
27th Apr 2022 - The Guardian

Pfizer, BioNTech seek U.S. authorization of COVID-19 booster shot for younger kids

Pfizer Inc and its partner BioNTech SE said on Tuesday that they had submitted an application to the U.S. health regulator for the authorization of a booster dose of their COVID-19 vaccine for children aged 5 to 11 years. The companies earlier this month reported data from a mid-to-late stage study showing a third dose of their shot increased protection against the original coronavirus version and the Omicron variant among children in the age group.
27th Apr 2022 - Reuters

More than half of Americans have had COVID infections, U.S. study shows

Following the record surge in COVID-19 cases during the Omicron-driven wave, some 58% of the U.S. population overall and more than 75% of younger children have been infected with the coronavirus since the start of the pandemic, according to a U.S. nationwide blood survey released on Tuesday. The study issued by the U.S. Centers for Disease Control (CDC) and Prevention marks the first time in which more than half of the U.S. population has been infected with the SARS-CoV-2 virus at least once, and offers a detailed view of the impact of the Omicron surge in the United States.
27th Apr 2022 - Reuters

WHO chief says we are 'increasingly blind' on COVID transmission

The head of the World Health Organization on Tuesday urged countries to maintain surveillance of coronavirus infections, saying the world was "blind" to how the virus is spreading because of falling testing rates. "As many countries reduce testing, WHO is receiving less and less information about transmission and sequencing," Director-General Tedros Adhanom Ghebreyesus told a news conference at the U.N. agency's headquarters in Geneva.
27th Apr 2022 - Reuters

Vice President Harris Taking Pfizer's Paxlovid to Treat Covid

Vice President Kamala Harris will take Pfizer Inc.’s Paxlovid Covid-19 therapy pill after testing positive for the virus earlier Tuesday, a treatment decision coinciding with the Biden administration’s push to expand access to the medication. Harris, 57, decided to start the treatment “after consultation with her physicians,” spokeswoman Kirsten Allen said in a tweet. Harris tested positive for the coronavirus earlier Tuesday but was not exhibiting symptoms of the disease, her office said. She spent the previous week in her home state of California and had not seen President Joe Biden since the April 18 White House Easter egg roll.
27th Apr 2022 - Bloomberg

Lawmakers ask FDA to lay out plans for reviewing COVID vaccines for young children

Even though most people in the U.S. have been eligible for COVID-19 vaccines and boosters for quite some time, children under 5 still don't have vaccine options. Now, lawmakers are asking the FDA to lay out its plans in this age group⁠—and address a perceived delay for Moderna's product. Yesterday, Congress’s Select Subcommittee on the Coronavirus Crisis sent a letter (PDF) to FDA Commissioner Robert Califf, M.D., requesting a briefing on the status of COVID-19 vaccines for the under 5 age group. The letter comes after U.S. chief medical adviser Anthony Fauci, M.D., indicated on CNN that the FDA is considering holding off on reviewing Moderna’s vaccine candidate in order to authorize it at the same time as Pfizer’s to “not confuse people” with a staggered rollout, the lawmakers wrote. That could lead to a potential delay of several weeks for Moderna's shot, they said.
26th Apr 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Apr 2022

View this newsletter in full

Adults given AstraZeneca much more likely to have Covid 'breakthrough' infections

Adults given the AstraZeneca vaccine were much more likely to suffer "breakthrough" Covid infections compared to those given the Pfizer vaccine, researchers have found. A study involving all fully vaccinated adults in Belgium showed substantially higher protection from mRNA vaccines such as Pfizer and Moderna compared to the AstraZeneca and Janssen brands, which used a more traditional viral vector formula. People who had recovered from Covid infection prior to being vaccinated also had the lowest risk of breakthrough infection overall.
26th Apr 2022 - HeraldScotland

Longer gap between coronavirus vaccine generate nine times as many antibodies, study

Longer intervals between primary Covid-19 vaccine doses generate nine times as many antibodies, according to a study. The study, which is available only as a preprint and not peer-reviewed yet, found that higher antibody levels due to longer gaps between doses had more effect in younger participants. Post-dose 1, those with previous infection had up to ten times higher antibody levels than naive individuals. After dose 2, those with previous infection had antibody levels more than twice as high as those who hadn't had previous infection. While dosing intervals didn't affect antibody levels in those with previous infection, a longer gap between infection and vaccination was linked to higher antibody levels, said researchers at the UK Health Security Agency (UKHSA). The findings were presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Portugal. Understanding the immune response to vaccination against Covid is integral to controlling the virus and reducing the number of deaths.
26th Apr 2022 - Times of India

Do Vaccines Protect Against Long Covid?

As the pandemic enters its third year, long Covid has emerged as an increasingly important concern. And many people are wondering whether getting a Covid shot can reduce their chances of developing long-term symptoms. The jury is still out, but a growing number of studies suggest that getting a Covid vaccine can reduce — though not eliminate — the risk of longer-term symptoms. The United Kingdom’s Health Security Agency conducted an analysis of eight studies that had been published on the topic before mid-January. It reported that six of the studies found that vaccinated people who became infected with the coronavirus were less likely than unvaccinated patients to develop symptoms of long Covid. The remaining two studies found that vaccination did not appear to conclusively reduce the chances of developing long Covid.
26th Apr 2022 - The New York Times

The BMJ Interview: WHO chief scientist optimistic for a pan-coronavirus vaccine in two years

Soumya Swaminathan tells Mun-Keat Looi of her worries about the relaxation of testing for global surveillance and the “two track pandemic” It’s a challenging time to be a scientist, let alone the first ever chief scientist at the World Health Organization, a relatively new role. Barely nine months into her tenure Soumya Swaminathan was faced with a once in a century global health emergency and an entirely new virus that would change the face of science and medicine dramatically. “It is incredible what we’ve learnt about this virus in just over two years,” she tells The BMJ, “we haven’t learnt as much about some other pathogens in decades of research.”
26th Apr 2022 - The BMJ

COVID-19 breath tests could be the future of living with the virus, but this pandemic solution has a catch

Whether it is a PCR test or the at-home variety, sending a swab up the nose to swirl around and test for COVID-19 has become a familiar but uncomfortable part of living through the pandemic. However, what if there was an alternative? For the first time, health authorities in the United States have given the green light to a COVID-19 breathalyser, a device promised to deliver results in less than three minutes. As new sub-variants once again push up case numbers, some experts hope it will be the first of many new tools to diagnose and, therefore, improve the way we live with the virus. There is even hope breath testing could eventually be used to detect and monitor other conditions, such as cancer.
26th Apr 2022 - ABC News

Study explores SARS-CoV-2 antibody responses in mild COVID-19 cases

Currently, the risk of reinfection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) ranges from 0% to 19.5% for 10 months after infection, indicating that protective immunity develops and is sustained post-infection. Various studies in animal models and humans have revealed that antibodies and B and T lymphocytes are vital to the protection and immune memory. Further, the quantity and quality of these immune responses are pivotal to long-term immunity, but the underlying mechanisms remain unclear yet. Age is an essential factor driving the outcome of diseases including COVID-19. Different studies have observed functional cellular and humoral responses among children against SARS-CoV-2 who primarily develop mild or asymptomatic disease. According to several reports, polyfunctional antibodies neutralize SARS-CoV-2 entry and recruit innate immune effectors such as neutrophils, complement systems, natural killer (NK) cells, and monocytes. These polyfunctional antibodies were inversely correlated with the severity of disease post-infection, indicative of diverse humoral responses.
26th Apr 2022 - News-Medical.Net

Covid-19 news: People hospitalised with omicron still face severe risk

People hospitalised with the supposedly milder omicron variant require similar levels of respiratory support and intensive care as those infected with delta. Heba Mostafa at John Hopkins University in the US and her colleagues studied more than 2000 people who tested positive for covid-19 between November and December 2021. The team recorded which variant the participants were infected with and their clinical outcomes. Results reveal 73 per cent of the participants who were hospitalised with delta needed extra oxygen, while 25 per cent required intensive care. Similarly, 67 per cent of those who were hospitalised with omicron required extra oxygen and 17 per cent needed intensive care.
26th Apr 2022 - New Scientist

New protein-based COVID-19 vaccine could help boost rates, say pharmacists

For New Brunswickers who have been hesitant or unable to get an mRNA COVID-19 vaccine, there's now a new option. Novavax Nuvaxovid, the first protein-based COVID vaccine authorized for use in Canada for people 18 and older, became available in New Brunswick last week, says the Department of Health. There are about 320 doses in the province, said spokesperson Bruce Macfarlane. Only four pharmacies are currently administering them — one each in Fredericton, Dieppe, Saint John and Miramichi. Ayub Chishti, pharmacist and manager of the Fredericton location, Campus Pharmacy, said the uptake so far "hasn't been that great."
26th Apr 2022 - CBC.ca

India approves two COVID vaccines for children under 12

India has approved emergency use of Biological E's COVID-19 vaccine Corbevax for children aged five to 12 and Bharat Biotech's Covaxin for six to 12-year olds, the country's health minister said in a tweet on Tuesday.
26th Apr 2022 - Reuters

U.S. FDA approves Gilead's COVID-19 drug for young children

The U.S. drug regulator on Monday granted the first full approval for treating COVID-19 in children aged 28 days and older to Gilead Sciences Inc's (GILD.O) drug remdesivir. The move comes months after the agency expanded the drug's emergency use authorization to also include children below 12 years of age weighing at least 3.5 kilograms. The Food and Drug Administration's (FDA) decision makes the drug the first approved COVID-19 treatment for children less than 12 years of age, the agency said. The approval is applicable to children who are hospitalized, or have mild-to-moderate disease and are at high risk of severe COVID-19
26th Apr 2022 - Reuters.com

U.S. Nears One Million Covid-19 Deaths

The Covid-19 mortality count—over 990,000 and still rising—is reflected in death certificates recorded by the CDC. Of these certificates, at least 90% list Covid-19 as the underlying cause of death, the CDC said. The remainder list the disease as a contributing cause. These records show how deaths have swept through the U.S. since the pandemic began, hitting states and populations unevenly. Early hot spots included places like New York City and New Jersey. The burden later shifted southward, including in states where vaccination rates have lagged. Vaccines have shown they reduce the risk of severe illness and death.
26th Apr 2022 - The Wall Street Journal

Pandemic Links to Children's Liver Ailment Eyed in U.K. Probe

Health authorities are investigating potential links between the pandemic and an outbreak of mysterious, acute hepatitis that’s sickened children in the U.K., the U.S. and other countries. The U.K. has detected adenovirus, a family of pathogens that cause a range of illnesses including the common cold, in three-quarters of the cases of the liver-inflaming disease, officials said Monday. Now they’re studying whether a lack of prior exposure to adenoviruses during pandemic restrictions or a previous infection with SARS-CoV-2 or another virus may be related. The researchers analyzed 111 cases found in the U.K. as of April 20, the government said, including 81 in England.
26th Apr 2022 - Bloomberg

Can Nasal Sprays Work on Covid? Meissa Vaccines Thinks So

“Covid isn’t just a sprint, it’s a marathon,” says Moore, the relentlessly upbeat founder of Meissa Vaccines Inc. Today’s vaccines have largely won the sprint of preventing serious disease, “and thank goodness for that,” he says. “But now we need something else to gain control of the virus.” Moore is among a growing cohort of virologists proposing we spray vaccines up people’s noses rather than inject them into arms. The advantage of that approach, they argue, is it can trigger the body to develop infection-blocking defenses in the sinuses and throat and allow it to start fighting illness much faster than an injected vaccine can.
26th Apr 2022 - Bloomberg

Majority of family members of Covid patients treated in the ICU report PTSD symptoms

A majority of family members of Covid-19 patients treated in ICUs reported significant symptoms of post-traumatic stress disorder in the following months, according to a study published Monday that sheds new light on the impact of hospital visitation restrictions during the pandemic. The prevalence of PTSD symptoms was roughly twice the rate typically seen after a family member’s ICU stay before the pandemic, which the authors said was likely explained by the lack of access to loved ones during their ICU stay. “Those with higher scores reported more distrust of practitioners,” according to the study, published in JAMA Internal Medicine, and PTSD symptoms were especially prevalent among women and Hispanic family members. Earlier studies have shown that “active engagement of families at the bedside reduces stress-related symptoms,” especially those of PTSD, the researchers said, but early in the pandemic, most hospitals prohibited or strictly limited in-person visits by family members to contain the spread of the coronavirus.
25th Apr 2022 - STAT News

What is Omicron XE? Symptoms of the new Covid variant as hundreds of cases found in UK - 637 cases of the new variant have been detected in England

A new sub-variant of Omicron has been found in UK as the country battles a renewed surge of the coronavirus.The Office for National Statistics (ONS) said that 4.9 million people in the UK were infected with Covid-19 as of last weekend - a record high during the pandemic. The surge is cases is thought to be down to people mixing more freely since Covid restrictions were dropped and the Omicron BA.2 sub-variant.
25th Apr 2022 - The Independent

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Apr 2022

View this newsletter in full

Nine Omicron symptoms affecting fully vaccinated — and two early signs you might have it

China has put nearly 30 million people under strict lockdown measures as the country recorded a steep rise in new coronavirus infections, which have hit a two-year high. The country has taken some of the most drastic measures since the start of the pandemic, even though its caseload is low compared with other major countries because it has tethered itself tightly to a “zero-Covid” strategy. The latest increase is due to Omicron, reported to be the dominant variant. First detected in Southern Africa and Hong Kong in November 2021, Omicron was soon confirmed as the dominant variant in the UK in December.
25th Apr 2022 - The Independent

Vaccines may have prevented 234,000 COVID-19 deaths in the US

Approximately 234,000 COVID-19 deaths in the United States could have been prevented since June with vaccines, according to a data analysis by Health System Tracker. Vaccines became available for free to all adults in the US in May of last year, and Health System Tacker estimated that by June, they could have all been fully vaccinated. The analysis took all adult COVID deaths from June 2021 to March 2022. Children's deaths were excluded because vaccines were made available to them later than adults and not for all children at once.
25th Apr 2022 - The Jerusalem Post

World's Biggest Vaccine Maker Serum Halts Production Over Millions of Unused Doses

Serum Institute of India Ltd., the world’s largest vaccine manufacturer and a key supplier of Covid-19 inoculations to developing countries, has stopped making fresh batches of shots after its stockpile grew to 200 million doses amid a global supply glut. “We have got 200 million doses of stock. We had to shut down production in December,” Serum’s chief executive officer Adar Poonawalla said at the India Economic Conclave organized by Times Network on Friday, saying he was worried about wastage if the shots expired. “I have even offered to give free donations to whoever wanted to take it.”
25th Apr 2022 - Bloomberg

Vaccine effectiveness against COVID-19 infection and related hospitalization

In the present study, the researchers estimated the effectiveness of two and three doses of COVID-19 messenger ribonucleic acid (mRNA) vaccines against SARS-CoV-2 Alpha, Delta, and Omicron variant infection and related hospitalization. The study population comprised Denmark residents aged 12 years or older in a time period where either the Alpha, Delta, or Omicron variants were dominant. The team included only the first SARS-CoV-2 positive polymerase chain reaction (PCR) test of a participant. They obtained information on all laboratory-confirmed positive reverse transcription-PCR (RT-PCR) results from the Danish microbiology database (MiBa). COVID-19-related hospitalization was defined as a new hospital admission lasting at least 12 hours, occurring within two days prior to or 14 days after the diagnosis with either the SARS-CoV-2 Alpha, Delta, or Omicron variant infection.
25th Apr 2022 - News-Medical.Net

The quest for a universal coronavirus vaccine

As vaccine makers rush to stamp out new Covid-19 variants, some scientists have set their sights higher, aiming for a universal coronavirus vaccine that could tackle any future strains and possibly even stave off another pandemic. Since the race for a first Covid jab supercharged a new generation of vaccine technology, there have been numerous efforts to develop pan-coronavirus immunisation. Drew Weissman of the University of Pennsylvania, who was a pioneer of the mRNA technology used in Pfizer's Covid vaccine, is leading one such project. He said the problem with updating current vaccines to target all existing strains -- a plan announced by Pfizer earlier this month -- is that "new variants are going to appear every three or six months".
25th Apr 2022 - FRANCE 24 English

What science journalism can't tell us about Covid-19 deaths

In the first piece of science journalism I ever wrote, I compared deciphering the effects of climate change to baking a cake. I was a college sophomore. This was homework. We were to read a study and then find an analogy for it, transforming what we found dizzying and technical into something easily imaginable. In my hands, an existential threat became dessert. I don’t remember exactly why I thought that computer models showing possible futures for an ocean inlet were best conveyed through recipes and increments of butter. But I do remember what (I think) the professor wanted us to remember: When an idea is hard to grasp — too big, too small, too abstruse, too abstract — liken it to something else. It’s so fundamental it’s almost a cliché, so prevalent it’s almost unnoticeable. We describe genes as blueprints, receptors and viruses as locks and keys. We take the measure of galaxies in celestial football fields.
25th Apr 2022 - STAT News

Unvaccinated people increase risk of COVID-19 infection among vaccinated: new study

Even with high immunization rates, unvaccinated people threaten the safety of people vaccinated against the COVID-19 virus, suggests a new study published in the Canadian Medical Association Journal. “We’ve really tended to forget that we’re in a pandemic of a communicable disease, which means that our actions affect those around us,” Dr. David Fisman, the study’s coauthor and professor of epidemiology at the University of Toronto’s Dalla Lana School of Public Health, told Global News.
25th Apr 2022 - Global News

Only 29% of UK Covid hospital patients recover within a year

Fewer than one in three people who have been hospitalised with Covid-19 have fully recovered a year after they succumbed to infection. That is the shock finding of a survey into the impact of long Covid in the UK. The team of scientists and doctors at Leicester University also found that women had poorer recovery rates than men after hospitalisation, while obesity was also likely to hinder a person’s prospects of health improvements. Among the symptoms reported by patients a year after their initial infection were fatigue, muscle pain, poor sleep and breathlessness. “Given that more than 750,000 people have been hospitalised in the UK with Covid-19 over the past two years, it is clear from our research that the legacy of this disease is going to be huge,” said Rachael Evans, one of the study’s authors.
25th Apr 2022 - The Guardian

Regulator asks Valneva for more information on its COVID vaccine candidate

French drugmaker Valneva said on Monday that the European Medicines Agency (EMA) had asked for more data on its COVID-19 vaccine, precipitating a sharp fall in its shares. The latest EMA setback comes after Britain earlier this month cleared the use of Valneva's vaccine, becoming the first European country to give its shot the green light. Valneva said the EMA Committee for Medicinal Products for Human Use (CHMP) had a fresh list of questions, including requests for additional data and for further justification of a conditional marketing authorisation for the vaccine. "We are disappointed that the EMA has not considered our submissions sufficient to date. We remain fully committed and dedicated to working jointly with the regulators towards a product approval," Valneva CEO Thomas Lingelbach said in a statement. Valneva's share price slumped about 15.5%, putting the stock on track for its worst day since Jan. 4.
25th Apr 2022 - Investing.com

Japan's Shionogi says COVID-19 pill shows rapid clearance of virus

An experimental treatment from Shionogi & Co Ltd has shown rapid clearance of the virus that causes COVID-19, according to new data, the Japanese drug maker said on Sunday. The pill, S-217622, "demonstrated rapid clearance of the infectious SARS-CoV-2 virus", Shionogi said in a statement, citing Phase-2b results from the Phase II/III clinical trial of the drug. The company has global aspirations for the antiviral pill, which is now being evaluated by Japanese regulators.
25th Apr 2022 - Reuters

Roche sees slowdown in COVID-driven sales growth

Roche's first-quarter sales rose 10% on strong U.S. demand for rapid COVID-19 antigen tests and specialty drugs but the Swiss drugmaker reaffirmed that a drop in pandemic-related demand would put the brakes on growth. Chief Executive Severin Schwan predicted much lower COVID related sales, mainly from tests and antibody treatment Ronapreve, from now on. "There is of course a scenario where there is an upside in the winter season, depending on how COVID-19 will develop but that is not our planning scenario," he said on a call with reporters on Monday.
25th Apr 2022 - Reuters

Gilead touts analysis showing COVID antiviral Veklury performs best when given early in illness

Coming off a World Health Organization (WHO) recommendation for the use of Veklury in non-hospitalized COVID-19 patients, Gilead Sciences is touting real-world evidence that could help expand the WHO endorsement to those who are hospitalized with a severe infection. While the FDA approved the infused antiviral for emergency use in patients with severe COVID in October of 2020 and more than 40 other countries have done the same, the WHO has not followed suit in a key area where options are limited. But a look at the Premier Healthcare Database of 853,219 patients hospitalized in the U.S. for COVID suggests the increased use of Veklury has helped improve outcomes.
25th Apr 2022 - FiercePharma

COVID shots still work but researchers hunt new improvements

COVID-19 vaccinations are at a critical juncture as companies test whether new approaches like combination shots or nasal drops can keep up with a mutating coronavirus — even though it’s not clear if changes are needed. Already there’s public confusion about who should get a second booster now and who can wait. There’s also debate about whether pretty much everyone might need an extra dose in the fall. “I’m very concerned about booster fatigue” causing a loss of confidence in vaccines that still offer very strong protection against COVID-19’s worst outcomes, said Dr. Beth Bell of the University of Washington, an adviser to the U.S. Centers for Disease Control and Prevention.
24th Apr 2022 - The Associated Press

COVID-19 third leading cause of death in US in 2021

COVID-19 was the third leading cause of death in the United States last year, and deaths from COVID-19 increased by 1% in 2021 over 2020, according to new data from the National Vital Statistics System released today by the Centers for Disease Control and Prevention (CDC). Only heart disease and cancer killed more Americans than COVID-19, with provisional death tolls from each cause totaling 693,000, 605,000, and 415,000, respectively. Those were also the three leading killers in 2020.
22nd Apr 2022 - Cidrap

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Apr 2022

View this newsletter in full

Long Covid May Be Result of Coronavirus Persisting in Feces

Covid-19 patients can harbor the coronavirus in their feces for months after infection, researchers found, stoking concern that its persistence can aggravate the immune system and cause long Covid symptoms. In the largest study tracking SARS-CoV-2 RNA in feces and Covid symptoms, scientists at California’s Stanford University found that about half of infected patients shed traces of the virus in their waste in the week after infection and almost 4% patients still emit them seven months later.
23rd Apr 2022 - Bloomberg

EU regulator backs using Pfizer COVID shot as booster after other vaccines

A European Medicines Agency (EMA) committee on Friday recommended approving the use of Pfizer and BioNTech's COVID-19 vaccine, Comirnaty, as a booster for adults who have previously been inoculated with other vaccines. The recommendation from Europe's drug regulator comes days after global COVID-19 cases surpassed 500 million, according to a Reuters tally, as the highly contagious BA.2 sub-variant of Omicron surges in many countries. Some European countries are now seeing a slower uptick in new cases, or even a decline, but the region is still reporting over 1 million cases about every two days, according to the Reuters tally published on Thursday
23rd Apr 2022 - Reuters

‘Best therapeutic choice’: WHO backs Pfizer’s COVID antiviral

The World Health Organisation (WHO) has given its backing to Pfizer’s Paxlovid treatment for COVID-19 after studies showed the antiviral pill reduced the risk of high-risk patients being admitted to hospital by 85 percent. The WHO announced on Thursday it was making a “strong recommendation” for the use of Paxlovid – a combination of nirmatrelvir and ritonavir – for people with mild and moderate COVID-19 but at risk of hospital admission, calling it the “best therapeutic choice for high-risk patients to date”.
22nd Apr 2022 - Al Jazeera English

Spanish health worker battled Delta and Omicron within three weeks of each other, scientists find

People can get reinfected with Covid within three weeks, scientists say. Experts have told how a 31-year-old Spanish healthcare worker battled Delta and Omicron within a 20-day period. Researchers believe the unidentified woman's case is the shortest reinfection gap since the pandemic began. The woman, whose battle with the virus was showcased at a medical conference, had received her Covid booster vaccine. Doctors in Catalonia who treated her it shows fully jabbed people 'cannot assume they're protected against reinfection' — even if they have battled the virus before. Dr Gemma Recio, of the Institut Catala de la Salut, added: 'This case highlights the potential of Omicron to evade the previous immunity acquired either from a natural infection with other variants or from vaccines. 'In other words, people who have had Covid cannot assume that they are protected against reinfection, even if they have been fully vaccinated.'
22nd Apr 2022 - Daily Mail

Patient died after 505-day Covid infection, the longest on record

UK doctors treated what they think is the longest Covid infection on record: 505 days. The patient was immunocompromised and eventually died. The patient first caught Covid in early 2020. They had symptoms and the infection was confirmed with a PCR test. They were in and out of hospital many times over the next 72 weeks, for both routine checks and care. On each occasion – about 50 in all – they tested positive, meaning they still had Covid. The doctors, from King's College London and Guy's and St Thomas' NHS Foundation Trust, say detailed lab analysis revealed it was the same, persistent infection, rather than repeated bouts.
22nd Apr 2022 - Boing Boing

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Apr 2022

View this newsletter in full

Antibody response to Pfizer-BioNTech COVID-19 vaccine over 6 months

The binding responses and temporal dynamics of antibodies elicited against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) due to vaccination must be fully understood to design future vaccination strategies. A new study published in PLoS ONE characterizes the antibody response to BNT162b2, the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine. This study analyzes the temporal dynamics of immunoglobulin G (IgG) and IgM antibody response to five different SARS-CoV-2 epitopes over a period of six months after vaccination.
21st Apr 2022 - News-Medical.Net

Codiak Presents New Preclinical Data Supporting Development of a Broadly Protective Pan Beta-Coronavirus Vaccine

Codiak BioSciences, a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based candidates as a new class of medicines, today announced new preclinical data from its pan beta-coronavirus vaccine program, which aims to protect against all SARS-CoV-2 variants of concern and potential future strains belonging to the beta-coronavirus family. The data, which are being presented today at the World Vaccine Congress 2022 in Washington, D.C., demonstrate the potential for a novel engineered exosome-based vaccine candidate derived from Codiak’s exoVACC™ platform to induce cross-neutralizing antibody protection against multiple strains of coronaviruses and an antigen-specific and comprehensive immune response against structurally conserved regions of multiple coronavirus variants.
21st Apr 2022 - BioSpace

Novavax publishes positive initial data for first combined Covid and flu vaccine

Novavax has published the first clinical data for a combined Covid-19 and flu vaccine, with promising initial findings that a two-in-one shot could be safe and effective. The trial, conducted in Australia, studied the combined shot in almost 650 people aged 50 to 70. An initial analysis found that their immune responses were similar to that for Novavax’s standalone Covid-19 vaccine and its flu vaccine candidate, which is waiting for regulatory approval. The safety profile was also similar to the individual vaccines, with no serious adverse events.
21st Apr 2022 - Financial Times

Third Covid-19 vaccine dose offers ‘prolonged immune response’ – UK-wide study

A UK-wide study has found a prolonged immune response from third doses of Covid-19 vaccines. The Cov-Boost study, led by the University Hospital Southampton (UHS), compared immune responses to seven vaccines used as a booster 28 days after participants had received two initial doses of either the AstraZeneca or Pfizer vaccines. The latest findings, published online in the Journal of Infection, show “strong immune responses” are still seen 84 days after third jabs, with five of the Covid-19 vaccines currently approved for use in the UK (AstraZeneca, Pfizer, Moderna, Janssen and Novavax vaccines). Of these vaccines, only three – Pfizer, Moderna and AstraZeneca – have been used in the UK booster programme.
21st Apr 2022 - The Independent

Nearly half of those recovering from coronavirus infection endure ‘long Covid’ symptoms, study finds

An analysis of data from 50 studies looking at 1.6 million people suggests that as much as 43 per cent of those infected with the coronavirus experienced post-Covid conditions, pointing to the need for better diagnosis and care for “long Covid” patients. Post-Covid conditions are clinically defined by the World Health Organisation (WHO) as mid- and long-term symptoms – also known as long Covid – occurring in individuals after infection with the SARS-CoV-2 virus. The research, published this week in the Journal of Infectious Disease, assessed 23 symptoms reported across 36 of the studies and found that shortness of breath, sleep problems, and joint pain was widely reported by those who had recovered from the novel coronavirus infection.
21st Apr 2022 - The Independent

Air pollution increases risk of Covid infection among young adults, study suggests

Air pollution heightens the risk of Covid-19 infection among young adults, a new study suggests. Previous studies have shown that areas of poor air quality have more cases of Covid-19, pointing to a potential link between the virus and rates of infection. The researchers merged a population-based project which has followed more than 4,000 participants in Stockholm from birth with Sweden’s national communicable disease registry, SmiNet. They identified 425 people who had tested positive for Sars-CoV-2 between May 2020 and the end of March 2021. The average age of the participants was 26, and 54 per cent were women.
21st Apr 2022 - The Independent

Covid-19: Has the spread of omicron BA.2 made antibody treatments redundant?

Drug regulators are reviewing authorisations for monoclonal antibody treatments just months after they were issued. Elisabeth Mahase asks what the future holds for this class of biologicals The US Food and Drug Administration has removed its authorisation for anti-SARS-CoV-2 monoclonal antibody treatment sotrovimab because of concerns that it is ineffective against the omicron subvariant BA.2, which is now dominant in the US. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) authorised sotrovimab for high risk over 12s with mild to moderate covid-19 in December 20212 after reporting that a single dose, given as an intravenous infusion over 30 minutes, reduced the risk of hospital admission and death by 79% in high risk adults with symptomatic covid-19. The regulator has told The BMJ that it is also now reviewing the treatment to see if the “benefit-risk balance remains favourable.” Laura Squire, the MHRA’s chief officer for healthcare access and quality, said, “We are in contact with the FDA and are looking closely at the data supporting their decision.”
21st Apr 2022 - The BMJ

COVID-19: Moderna's bivalent vaccine more effective against variants

The U.S. pharmaceutical company Moderna announced Tuesday that its updated mRNA COVID-19 booster had produced a better immune response in clinical trials against several SARS-CoV-2 variants, including Omicron and Delta. The booster is a type of vaccine scientists call “bivalent,” which works by stimulating an immune response against two different antigens. Moderna designed the new formula to target both the Beta variant, which surfaced in South Africa in July 2020, and the original variant of SARS-CoV-2. The boosters currently in use—from Moderna, Pfizer, and others—were only based on the original variant.
21st Apr 2022 - Medical News Today

Covid-19 still isn't like the flu

When Delta Air Lines referred to Covid-19 as an "ordinary seasonal virus" after a federal judge struck down the Biden administration's mask mandate for public transportation, they were partly right: there is some evidence that it is seasonal. But it is far from ordinary, and it's still not the same as the flu. The lifting of the transportation mask mandate marks another turning point in the Covid-19 pandemic in the United States, and there are many ways to describe the situation at this inflection point.
21st Apr 2022 - CNN

COVID-19 vaccines do not heighten heart inflammation risk in most individuals

Recent studies have suggested that COVID-19 vaccines may increase the risk of heart inflammation, which can be potentially fatal. A meta-analysis synthesizing data from 22 previous studies suggests that the risk of heart inflammation after a COVID-19 vaccine was similar to that following vaccination against other diseases. Males and individuals under the age of 30 were at a higher risk of heart inflammation, especially after the second dose. These results suggest that the risk of heart inflammation after having a COVID-19 vaccine is generally low, supporting previous data about their safety.
21st Apr 2022 - Medical News Today

Healthcare worker tests positive for COVID-19 twice in 20 days in world first since pandemic began, study suggests

A healthcare worker was infected with COVID-19 twice in just 20 days - believed to be the shortest time between two infections documented since the pandemic began. The Spanish woman, 31, became infected with the Delta variant followed by the Omicron variant of the virus in under three weeks, according to a study. Researchers say the case shows that even vaccinated people who have had COVID-19 "cannot assume they are protected against reinfection". Dr Gemma Recio, of the Institut Catala de la Salut in Spain, one of the study's authors, said it highlights the potential of the Omicron variant to evade previous immunity.
21st Apr 2022 - Sky News

Moderna to file for EUA of COVID-19 shot for very young kids by April end

Moderna plans to submit an application to the U.S. health regulator for emergency use authorization (EUA) of its COVID-19 vaccine among kids between the ages of six months to five years by end of the month, a company spokesperson said on Wednesday. The Omicron variant was predominant during Moderna's pediatric trial, and the drugmaker said two doses were around 38% effective in preventing infections in 2 to 5-year-olds and 44% effective for children aged 6 months to under 2 years.
21st Apr 2022 - Reuters

Taiwan approves second COVID booster dose, infections yet to peak

Taiwan's government has approved a second COVID-19 booster vaccine dose for those 65 and older, and third boosters for the immunocompromised, as it looks to step up its fight against a spike in domestic infections that has yet to peak. While Taiwan is dealing with a rise in local cases, the numbers overall remain small - 15,544 since Jan. 1 - and just four people have died, with more than 99% of those infected reporting either minor or no symptoms. Taiwan's Centres for Disease Control said late Wednesday it had approved second booster shots for the elderly, as well as residents of long-term care facilities.
21st Apr 2022 - Reuters

CureVac, GSK's experimental COVID variant vaccine effective in mice -study

CureVac and GSK's second-generation vaccine candidate targeting two recent COVID-19 variants has been shown to be highly effective in preclinical studies on mice, CureVac said, as it seeks to catch up with rivals' development work. A study in mice showed that the bivalent vaccine candidate, designed to address the Beta and Delta variants of the coronavirus, elicited neutralizing antibody levels that were comparable to the monovalent vaccine candidates targeting only one of the variants.
21st Apr 2022 - Reuters

COVID-19 tracker: UK study finds strong responses 84 days after booster shot

A U.K.-wide study found prolonged “strong immune responses” 84 days after participants received a booster COVID-19 shot. The study, led by the University Hospital Southampton (UHS) and published in the Journal of Infection, tested immune responses after seven different vaccines used as a boosters 28 days after receiving two doses of AstraZeneca or Pfizer vaccines. While different initial vaccines yielded different results from the booster, “the rate that immune cell responses declined after third doses was similar between all the vaccine combinations and doses,” according to a UHS spokeswoman quoted in the Evening Standard. The study also found that a half dose of Pfizer’s vaccine prompts similar responses to a full dose at three months, which could “help in planning global vaccine supply and delivery,” according to Saul Faust, a professor of pediatric immunology and infectious diseases at the University of Southampton and director of the NIHR Southampton Clinical Research Facility.
21st Apr 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Apr 2022

View this newsletter in full

Moderna and Pfizer urged to share vaccine technology with developing world

Pressure is mounting on Moderna and Pfizer to share vaccine technology with the developing world after the two biggest proxy advisers lent support to shareholder resolutions. Institutional Shareholder Services has recommended that investors vote in favour of proposals by Oxfam America that would compel Moderna and Pfizer to commission third-party reports about transferring their vaccine technology. The drive to expand access to the well-performing mRNA vaccines comes as Moderna unveiled strong trial results for a new “bivalent” vaccine. Oxfam is lobbying to create a more equal distribution of Covid-19 vaccines, arguing that not sharing the IP and technical knowhow creates reputational risks and could slow the end of the pandemic.
20th Apr 2022 - Financial Times

Studying the immune response after COVID-19 vaccination using smartwatches and fitness bands

This was an observational, longitudinal, prospective, direct-to-participant, app-based study titled Digital Engagement and Tracking for Early Control and Treatment (DETECT) study. Daily data were collected from smart wearable devices. The data collection period included the two weeks before and after each vaccination dose. Data was collected from 7,298 participants who reported receiving at least one dose of the vaccine. A total of 6,803 participants received both doses of an mRNA vaccine. Only 437 participants received the Johnson & Johnson single-dose adenovirus-based vaccine and therefore, were excluded from this study.
20th Apr 2022 - News-Medical.Net

6 Covid mysteries experts hope to unravel

1. How will the virus evolve next? 2. What will future waves look like? 3. If you’ve never had Covid, how worried should you be right now? 4. How, exactly, does the virus transmit from person to person? 5. Will we get a new, better generation of vaccines, therapeutics, and tests? 6. How long before we understand long Covid?
20th Apr 2022 - STAT News

Pregnant women 'afterthought' in Covid jab rollout

Pregnant women have been an "afterthought" during the coronavirus pandemic and some of their deaths were "preventable", a leading scientist has told Newsnight. Data shows there have been at least 40 maternal deaths from Covid in the UK. Almost all were unvaccinated and more than half happened after pregnant women were advised to take-up the vaccine. The regulator says vaccines during pregnancy are "safe". Professor Marian Knight, who investigates every maternal death in the UK, said lifesaving messaging is still "struggling" to reach
20th Apr 2022 - BBC News

Scientists urge China to replace its faltering Covid vaccines

Scientists are urging China to look for alternatives to its two homegrown Covid-19 vaccines to tackle its Omicron outbreak, amid mounting concerns about the jabs’ efficacy against the variant. The country is struggling with two problems as it faces its worst Covid-19 surge since the start of the pandemic: the sluggish take-up of booster doses — authorities said this week that only 57 per cent of people over 60 have been fully vaccinated with three jabs — and homegrown vaccines that are much less effective than foreign-produced jabs.
20th Apr 2022 - Financial Times

Novavax, fashionably late to the COVID-19 vaccine party, could still reap $5B in 2022: analyst

After a winding path to a coronavirus vaccine launch that still hasn’t reached the U.S., Novavax's program could be destined to reap billions of dollars in sales this year, one group of analysts predicts. Chalk it up to what’s looking like a strong first-quarter revenue haul for the Gaithersburg, Maryland-based biotech, Jefferies analysts wrote in a note to clients Tuesday following a chat with Novavax’s chief financial officer Jim Kelly. The company’s only marketed product is its protein-based coronavirus vaccine Nuvaxovid, which is slowly racking up green lights in places like the EU, the U.K., Australia and South Korea.
20th Apr 2022 - FiercePharma

MSD obtains Singapore HSA interim authorisation for Covid-19 antiviral

MSD (Merck in North America) has obtained interim authorisation under the Pandemic Special Access Route (PSAR) from Singapore Health Sciences Authority (HSA) for its antiviral medicine Lagevrio (molnupiravir) to treat Covid-19. Lagevrio is the second oral antiviral therapy to obtain authorisation in the region to treat mild to moderate Covid-19 in people of the age 18 years and above. It is intended for patients who are at risk of disease progression to severe Covid-19 and/or hospital admission and for those with no clinically appropriate substitute Covid-19 treatment options available.
20th Apr 2022 - Pharmaceutical Technology

Hong Kong launches new platform for recovered Covid-19 patients

From April 19, people who've recovered from Covid-19 can now download a QR code issued by the government via the Covid-19 Electronic Vaccination and Testing Record System and use the electronic record when entering designated premises like restaurants, shopping malls, and supermarkets instead of the vaccine pass. The QR code is valid within six months from the date of recovery. Downloading the recovery record QR code will require recovered Covid-19 patients to provide the number and date of issue of their Hong Kong identity card, discharge date from the hospital, or positive test result for identification. The recovery QR code may also be downloaded using the iAM Smart app and the latest version of the eHealth app. Those who received isolation orders issued by the Department of Health (DH) will instantly get the recovery record QR code. The QR code may be saved in the LeaveHomeSafe mobile application to facilitate scanning when entering a Vaccine Pass premises.
20th Apr 2022 - Time Out

Vaccine maker Oxford Biomedica pauses production as AstraZeneca partnership reviewed

The chief executive of Oxford Biomedica has hailed an “exceptional” year as a deal to manufacture Britain’s Covid-19 vaccine boosted revenues and led to a string of deals. Revenues jumped 63% last year to £142 million, as a partnership with AstraZeneca led to surging business. Operating profits rose from £7.3 million to £35.9 million in 2021. Chair and interim CEO Dr Roch Doliveux said: “I am delighted with our performance in 2021 which was a true testament to the hard work of all our employees. “2021 financial performance was exceptional due to large-scale manufacture of the adenovirus-based Oxford AstraZeneca COVID-19 vaccine, and we have successfully manufactured over 100 million doses since the partnership began. “
20th Apr 2022 - Evening Standard

North Wales company to stop producing Covid-19 Vaccine

A pharmaceutical company that has helped in the production of the Covid-19 vaccine will 'right size' business as the wide-scale rollout comes to an end. Wockhardt, based on the Wrexham Industrial Estate, is a global pharmaceutical and biotechnology organisation that had a contract with the UK Government to help produce Covid- 19 vaccines during the mass roll-out. Now, the rollout is coming to an end, and the company will be scaling back the work, leading to job losses. A spokesperson for the company said: “Wockhardt is incredibly proud to have played a vital role in mitigating the global impact of COVID-19.
20th Apr 2022 - North Wales Chronicle

Arcturus' self-amplifying COVID-19 mRNA vaccine meets Phase 3 primary efficacy endpoint

Arcturus Therapeutics Holdings Inc. has reported topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, its self-amplifying mRNA COVID-19 vaccine candidate.
20th Apr 2022 - BioPharma-Reporter.com

Nearly every adult in Scotland has Covid-19 antibodies, Office for National Statistics estimates say

Nearly every adult in Scotland would have tested positive for Covid-19 antibodies, official estimates have found. At the end of March, 99% of those over 15 years old are estimated to have developed the infection-fighting molecules, the Office for National Statistics said. This is higher than in both England and Wales. The measurement shows the impact of coronavirus infections and the vaccine programme.
20th Apr 2022 - STV News

J&J pulls COVID vaccine sales forecast due to low demand, supply glut

Johnson & Johnson rescinded its forecast for sales of its COVID-19 vaccine, as hesitancy in low income countries has led to a glut of supply of a shot once hoped to be the inoculation of choice for the developing world. The company had previously predicted as much as $3.5 billion in 2022 sales from the single-dose vaccine, but demand has withered. Still, the company reported strong results for its medical devices business and raised its dividend, driving shares up around 3%.
20th Apr 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Apr 2022

View this newsletter in full

Ocugen gains rights to market Covid-19 vaccine in Mexico

Ocugen and Bharat Biotech have signed an amendment to their co-development, supply and commercialisation agreement for expanding the former’s exclusive territory to include marketing of their Covid-19 vaccine, Covaxin (BBV152), in Mexico. With the latest development, Ocugen will have complete commercialisation rights to Covaxin in North America. The expansion of licence between the companies for supply in Mexico has the same profit share structure as in the US.
19th Apr 2022 - Pharmaceutical Technology

Japan’s MHLW grants approval for Takeda’s Covid-19 vaccine

The Japan Ministry of Health, Labour and Welfare (MHLW) has granted manufacturing and marketing approval to Takeda’s Covid-19 vaccine, Nuvaxovid Intramuscular Injection, for initial and booster vaccination in people of the age 18 years and above. The recombinant protein-based Covid-19 vaccine contains Matrix-M adjuvant. It can be stored at a refrigerated temperature of 2℃ to 8℃ and requires a standard vaccine supply chain for transportation. In August 2020, Takeda and Novavax entered a collaboration to develop, manufacture and supply the latter’s Covid‑19 vaccine candidate in Japan.
19th Apr 2022 - Pharmaceutical Technology

Cambridge start-up searches for next Covid jab in animal faeces

DIOSynVax, a UK start-up founded by a vet-turned-vaccinologist, is hoping genetic sequences of viruses discovered in animal faeces will give vital clues for creating a vaccine to help prevent future pandemics. The Cambridge university spinout is working on two vaccines that it believes will outlive the current crop of Covid-19 jabs, including the one created by researchers at rival Oxford university. Jonathan Heeney, who first became interested in coronaviruses when he diagnosed them in cats and cheetahs during his studies, said scientists were learning about future threats from the guano-covered floors of bat caves and waste from other animals including civet cats and pangolins.
19th Apr 2022 - Financial Times

The Israeli COVID vaccine has taken its last breath

The demise of BriLife, the Israeli COVID-19 vaccine project, whose development was announced by former Prime Minister Benjamin Netanyahu about two years ago, didn't surprise anyone. In spite of that, its ending was clandestine and modest. Nobody bothered to "attend the funeral" or to express condolences, and what began with great fanfare at the Israel Institute for Biological Research in Nes Tziona – on the way to an Israeli "vaccine project" that would cancel dependence on the international pharmaceuticals companies – is ending with a whisper. The news of the product's cancellation came from the American NRx Pharmaceuticals company, which signed a cooperation agreement with the Biological Institute, rubber-stamped by the Defense Ministry, less than a year ago. NRx is traded on Wall Street, and therefore was obligated to inform the stock exchange.
19th Apr 2022 - Haaretz

Immunologist warns of new COVID-19 strain spread in Ireland

An Irish immunologist has warned that a new, more infectious variant of COVID-19 is likely spreading in Ireland. A number of cases of the new variant, Omicron XE, have been confirmed across the UK, including Northern Ireland. Kingston Mills, an immunology professor at Trinity College Dublin, has warned that the strain is likely already circulating in the Republic of Ireland, which he said was behind the UK in terms of sequencing.
19th Apr 2022 - EURACTIV

Getting covid-19 over 50 increases the risk of getting shingles

People 50 and older who have had a mild case of covid-19 are 15 percent more likely to develop shingles (herpes zoster) within six month than are those who have not been infected by the coronavirus, according to research published in the journal Open Forum Infectious Diseases . The risk, however, was found to be even greater for older people who were hospitalized because of a more severe covid case, making them 21 percent more likely to develop shingles than those who did not have covid. The findings stem from data on roughly 2 million people — nearly 400,000 diagnosed with covid-19 and 1.6 million who had no coronavirus infection. Shingles is an outbreak of a painful rash or blisters on the skin, most often occurring on one side of the torso.
19th Apr 2022 - The Washington Post

Over two years into COVID-19 and the World is still facing an ongoing struggle

The world has crossed over two years into COVID-19, and we are still facing many of the same challenges we originally had, but with some better tools in our arsenal. Development of new drugs will still need to move forward, and countries will need to monitor disease prevalence to know if further lockdowns or mask mandates will need to be imposed. There are now 22 marketed vaccines for COVID-19, developed in record time, including Pfizer/BioNTech’s Comirnaty with over $247 billion in sales and Moderna’s mRNA-1273 with over $200 billion in sales.
19th Apr 2022 - Pharmaceutical Technology

Covid-19: India accused of trying to delay WHO revision of death toll

India has been accused of attempting to delay an effort by the World Health Organization to revise the global death toll from Covid-19 after its calculations suggested that the country had undercounted its dead by an estimated 3.5 million. India’s official number of deaths from Covid is 520,000. But according to in-depth analysis and investigations into the data by WHO, the total is more than 4 million, which would be by far the highest country death toll in the world. The figure tallies with previous estimates made by scientists, data analysts and medical journals that the true number of deaths from Covid in India was up to 10 times higher than that recorded in official statistics.
19th Apr 2022 - The Guardian

Moderna says dual variant booster with Beta more effective vs Omicron than current shot

Moderna Inc on Tuesday said a COVID-19 booster designed to target the Beta variant as well as the original coronavirus generated a better immune response against a number of virus variants including Omicron. Moderna said the results were a good sign for the company's plans for future shots targeting two COVID-19 variants. Dr. Jacqueline Miller, a top Moderna scientist, said the company had no immediate plans to file for authorization of the bivalent vaccine including the Beta variant. It will submit the data to the U.S. Food and Drug Administration in order to lay the groundwork for a future bivalent vaccine candidate that includes the Omicron variant as a target.
19th Apr 2022 - Reuters

Japan health ministry panel approves Novavax's COVID-19 vaccine

A Japanese Health Ministry committee said on Monday it has approved Novavax Inc's COVID-19 vaccine, setting the stage for full approval of the country's fourth shot for the coronavirus. The Japanese government has agreed to purchase 150 million doses of Novavax's recombinant protein type vaccine, which is to be manufactured domestically by Takeda Pharmaceutical Co.
19th Apr 2022 - Reuters

J&J suspends sales forecast for COVID vaccine, cuts profit view

Johnson & Johnson on Tuesday rescinded its forecast for sales of its COVID-19 vaccine, as hesitancy in low income countries has led to a glut of supply of a shot once hoped to be the inoculation of choice for the developing world. The company had previously predicted as much as $3.5 billion in 2022 sales from the single-dose vaccine, but demand has withered. Use of the shot has been weak in high-income countries, hurt by reports of rare, potentially deadly blood clots, production issues, including an accidental mix-up of ingredients by a contract manufacturer, and concerns about efficacy.
19th Apr 2022 - Reuters

Moderna announces step toward updating COVID shots for fall

Moderna hopes to offer updated COVID-19 boosters in the fall that combine its original vaccine with protection against the omicron variant. On Tuesday, it reported a preliminary hint that such an approach might work. Today’s COVID-19 vaccines all are based on the original version of the coronavirus. But the virus continues to mutate, with the super-contagious omicron variant — and its siblings — the latest threat. Before omicron came along, Moderna was studying a combination shot that added protection against an earlier variant named beta. Tuesday, the company said people given that beta-original vaccine combination produced more antibodies capable of fighting several variants — including omicron — than today’s regular booster triggers.
19th Apr 2022 - The Associated Press

SK advances Gates-backed COVID-19 antiviral spray toward clinic

SK bioscience is stepping up work on a nasal spray to prevent and treat COVID-19. With the Bill & Melinda Gates Foundation kicking in cash, the Korean biotech is preparing for initial process R&D for the production of the antiviral nasal spray. The spray is designed to deliver a protein to the nasal passages. Upon delivery, the protein forms a layer to stop the virus from penetrating deeper into the body. SK thinks the spray may also disrupt the ability of the virus to replicate, giving it a potential role in the treatment of people already infected with the pathogen. SK has transferred technology for the protein candidate from the University of Washington, where David Baker and his collaborators got the project underway in 2020 by identifying miniprotein inhibitors of SARS-CoV-2. Lauren Carter, a lead scientist at the university’s Institute for Protein Design, is continuing to work with SK on the project.
19th Apr 2022 - FiercePharma

Moderna data yield hope for better Covid boosters, but highlight complexity of figuring out how to give them

New data from Moderna offer hope that booster shots against Covid-19 could become at least somewhat more effective than they already are. But the data also point to how difficult it could be to determine exactly which Covid shots to give as annual boosters. On Tuesday Moderna released data testing a booster shot that is bivalent, meaning it contains equal amounts of vaccine from two different strains of the virus. This booster, currently known by the code number mRNA-1273.211, contains equal mRNA amounts of ancestral SARS-CoV-2 and spike proteins from the Beta variant of SARS-CoV-2, which originally emerged in South Africa. It does not contain vaccine targeted specifically against the Delta or Omicron variants that caused the most recent waves of Covid-19.
19th Apr 2022 - STAT News

Global data reveal half may have long COVID 4 months on

Worldwide, 49% of COVID-19 survivors reported persistent symptoms 4 months after diagnosis, estimates a meta-analysis of 31 studies published late last week in The Journal of Infectious Diseases. University of Michigan researchers, who conducted a systematic review on Jul 5, 2021, also found the prevalence of long COVID at 1 month at 37%, while it was 25% at 2 months and 32% at 3 months. Fifty studies were identified in the review, and 41 were included in a quantitative synthesis, and 31 reporting overall prevalence were meta-analyzed. The 50 studies included a total of 1,680,003 COVID-19 patients, including those who were hospitalized (67,161 patients from 22 studies), nonhospitalized (4,165 from 5 studies), and any COVID-19 patients, regardless of hospitalization status (1,608,677 from 23 studies).
18th Apr 2022 - CIDRAP

‘The equivalent of a plane's worth of people still die every day’: If you wear a mask on a train or plane, while others don’t, will it protect you from COVID-19?

Does it pay to be a mask-wearing outlier? On Monday, a federal judge in Tampa, Fla. threw out the national mask mandate for public transportation across the U.S., effectively giving airports and airlines, trains, and even ride-hailing services the option to keep mask rules or abandon them, resulting in mask-mandate rules that will vary depending on the city, company and mode of transport. The Centers for Disease Control and Prevention recently extended recommendations to wear masks to May 3. The Biden administration said the mask mandate on public transport would not be enforced as federal agencies decide how to respond to District Judge Kathryn Kimball Mizelle’s order
12th Apr 2022 - MarketWatch

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Apr 2022

View this newsletter in full

Study shows 99% on Indonesia's most populous island have COVID antibodies

Almost all residents of Indonesia's most populous island of Java have antibodies against COVID-19, owing to a combination of prior infection and vaccination against the virus, a government-commissioned survey showed. The March study of 2,100 people, conducted on Java, home to 150 million people, and Bali, Indonesia's top tourism destination, revealed 99.2% of people had COVID antibodies, a 6 percentage point increase from a December survey. Pandu Riono, an epidemiologist at the University of Indonesia, which conducted the survey with the health ministry, on Monday told Reuters the antibody levels in the latest survey were higher due to a wider booster shot rollout, as recipients had stronger protection.
18th Apr 2022 - Reuters

The case for testing Pfizer's Paxlovid for treating long COVID

Reports of two patients who found relief from long COVID after taking Pfizer Inc's antiviral Paxlovid, including a researcher who tested it on herself, provide intriguing evidence for clinical trials to help those suffering from the debilitating condition, experts and advocates say. The researcher said her chronic fatigue symptoms, which "felt like a truck hit me," are gone after taking the two-drug oral therapy. Long COVID is a looming health crisis, estimated to affect up to 30% of people infected with the coronavirus.
18th Apr 2022 - Reuters

Omicron-specific Sinopharm, Sinovac COVID vaccine candidates cleared for clinical trial

COVID-19 vaccine candidates developed by a Sinopharm subsidiary and Sinovac Biotech (SVA.O) to target the Omicron variant were approved for clinical trials in Hong Kong, the companies said on Saturday. Scientists worldwide are racing to study upgraded injections against Omicron, as data indicated that antibodies elicited by vaccines based on older strains show weaker activity to neutralise the highly transmissible variant.
18th Apr 2022 - Reuters

Pfizer, Moderna, J&J See Respiratory Virus RSV as Next Vaccine Target

After Covid-19, vaccine makers’ next big target is a respiratory virus that kills up to 500 children a year nationwide and has been among the leading causes of U.S. hospitalizations for decades. The respiratory syncytial virus, or RSV, infects nearly everyone at some point, causing mild, cold-like symptoms for most people. But it can lead to serious health problems such as difficulty breathing and pneumonia for infants and older adults. The virus has for decades eluded efforts to develop a vaccine, including a major setback in the 1960s when an experimental shot harmed some children in testing. RSV is one of the last remaining childhood diseases without an approved vaccine.
15th Apr 2022 - The Wall Street Journal

WHO warns coronavirus is far from settling into endemic situation

COVID-19 is far from becoming an endemic disease and could still trigger large outbreaks around the globe, the World Health Organization (WHO) said. WHO Health Emergencies Programme Director Michael Ryan said on Thursday that it was wrong to think that if COVID-19 settles down and becomes endemic, it will mean the end of the problem. “I certainly do not believe we’ve reached anything close to an endemic situation with this virus,” Ryan told a question-and-answer session on the WHO’s social media channels. “That is not an endemic disease yet,” he said.
15th Apr 2022 - Al Jazeera English

Pfizer to seek COVID booster for healthy 5- to 11-year-olds

Pfizer said Thursday it wants to expand its COVID-19 booster shots to healthy elementary-age kids. U.S. health authorities already urge everyone 12 and older to get one booster dose for the best protection against the newest variants -- and recently gave the option of a second booster to those 50 and older. Now Pfizer says new data shows healthy 5- to 11-year-olds could benefit from another kid-sized shot. In a small study, 140 youngsters who’d already gotten two shots were given a booster six months later, and researchers found the extra shot generally revved up their immune response. But a closer look at 30 of the children found a 36-fold increase in virus-fighting antibodies, levels high enough to fight the super-contagious omicron variant, Pfizer and its partner BioNTech said in a press release.
15th Apr 2022 - The Associated Press

Pfizer Says Covid-19 Booster in Children Ages 5 to 11 Sparked Immune Response Against Omicron

A booster dose of the Covid-19 vaccine from Pfizer Inc and BioNTech SE Inc. generated a strong immune response in children 5 to 11 years old, an encouraging sign for youngsters to maintain protection against the virus. The companies said Thursday that a late-stage study of a booster found the extra shot significantly increased antibody levels against the Omicron variant. The shot also raised antibody supply against the initial strain the vaccines were designed to fight. The booster shot was found to be safe and well-tolerated among the children in the study, the companies said. The results haven’t been peer-reviewed by independent experts or published in a medical journal. Separate studies have found that adults who receive a third dose of mRNA vaccines are less likely to become infected, or to develop severe disease, than those who got two doses.
15th Apr 2022 - The Wall Street Journal

Omicron BA.2 Is Advancing, but Covid-19 Hospitalizations Stay Muted

The Omicron BA.2 variant has dominated new infections in the U.S. for weeks without setting off a major surge so far, raising hopes among some public-health experts that the nation might dodge a more significant hit. BA.2 is in particular affecting the Northeast, where virus concentrations in wastewater are rising alongside reported infections in such places as New York, Washington, D.C., and Philadelphia. Concern about BA.2 prompted Philadelphia to restore an indoor-mask requirement and U.S. authorities to extend mask mandates for airplanes and other forms of transportation.
15th Apr 2022 - The Wall Street Journal

Covid-19 Breathalyzer Test Gets FDA Approval

A Covid-19 breathalyzer test with the ability to provide diagnostic results in three minutes has won emergency-use authorization from the U.S. Food and Drug Administration, the agency announced Thursday. The test, made by Frisco, Texas-based InspectIR Systems, is authorized for those 18 and older and in settings where samples are both collected and analyzed, such as doctor’s offices, hospitals or mobile testing sites. The device is about the size of a piece of carry-on luggage, the FDA said, and works by detecting chemical compounds in breath samples associated with SARS-CoV-2 infection. The agency said the test was validated in a study of 2,409 people, where it correctly identified 91.2% of positive samples and 99.3% of negative samples. It performed similarly in follow-up tests focused on the omicron variant. The breathalyzer’s sensitivity is comparable to that of rapid antigen tests, studies show.
15th Apr 2022 - Bloomberg

Fourth shot protects against severe Omicron outcomes; COVID may increase risk of rare eye blood clots

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Fourth vaccine dose protects vs Omicron for at least a month. A fourth dose of the COVID-19 vaccine from Pfizer and BioNTech provided significant added protection against severe disease, hospitalization and death for at least a month in older individuals, according to a study from Israel conducted when the Omicron variant was dominant. The estimated effectiveness of the fourth dose during days 7 to 30 after it was administered compared with a third dose given at least fourth months earlier was 45% against infection, 55% for symptomatic disease.
15th Apr 2022 - Reuters

Pfizer says booster in kids 5-11 produces ‘high’ immune response

Pfizer and BioNTech said Thursday that a third dose of their COVID-19 vaccine in children ages 5 to 11 produced a “high” immune response, and that they will apply for authorization for a booster dose in the age group soon. Pfizer said in a news release that a third dose of the vaccine in those 5 to 11 produced a 36-fold increase in levels of neutralizing antibodies against the omicron variant, compared to two doses. Antibody levels against the original version of the virus increased by six-fold.
15th Apr 2022 - The Hill

FDA authorizes 1st breath test for COVID-19 infection

The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples. The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider. Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
15th Apr 2022 - The Associated Press

UK clears 6th COVID shot despite canceling deal for doses

British authorities have authorized a coronavirus vaccine for adults made by French drugmaker Valneva, despite the government’s decision last year to cancel an order for at least 100 million doses. The U.K. is the first country to authorize Valneva’s vaccine, which is also under review by the European Medicines Agency. Britain’s medicines regulator said Thursday that the two-dose vaccine is intended for adults ages 18 to 50, with the second dose given about a month after the first. The Valneva vaccine is made with the decades-old technology used to manufacture shots for flu and polio. It is the sixth COVID-19 vaccine the U.K. has cleared and the only one that utilizes a “killed” virus; scientists grow the coronavirus in a lab and then inactivate the virus so it cannot replicate or infect cells.
14th Apr 2022 - The Associated Press

Pfizer/BioNTech say booster dose increases protection vs Omicron in kids aged 5-11

A third dose of the COVID-19 vaccine from Pfizer Inc and BioNTech produced significant protection against the Omicron variant of the coronavirus in healthy children ages 5 to 11, the companies said on Thursday. Blood serum analysis of 30 pediatric participants who received a booster dose in a study showed a 36-fold increase in Omicron neutralizing antibodies, the drugmakers said. Neutralizing antibodies against the original version of the virus for which the vaccine was designed rose six-fold following the booster shot.
14th Apr 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Apr 2022

View this newsletter in full

Pfizer's Bourla: COVID vaccines for new variants possible for Fall

Pfizer Chief Executive Albert Bourla said on Wednesday that the company could possibly develop a new vaccine that protects against the Omicron variant as well as older forms of COVID-19 by autumn. "It's easy to do something only against Omicron. What is scientifically and technically more challenging ... is to be effective against everything known so far, so you don't have two different vaccines for different variants," Bourla said, speaking at a press conference held by the International Federation of Pharmaceutical Manufacturers & Associations.
14th Apr 2022 - Reuters

Novavax's COVID-19 vaccine Nuvaxovid gets conditional approval in Switzerland

Novavax said Swissmedic granted conditional marketing authorization to its COVID-19 vaccine Nuvaxovid for individuals 18 years of age and older.The company said
13th Apr 2022 - Seeking Alpha

Study finds a consistent temporal association between mask use and COVID-19 vaccination status

The CRP study was carried out from April 2020 to June 2021 and is a prospective, multi-site cohort syndromic COVID-19 surveillance study of participants from ten healthcare settings in the mid-Atlantic and south-eastern USA. Participants were contacted via email or text and provided with surveys regarding their exposure to COVID-19, any COVID-19-related symptoms, and mask use. “Yes,” “No,” or “No interactions” were used to report the participant’s mask use. The study inclusion criteria consisted of: 18 years or older, enrolled by December 2020, and daily surveys needed to be completed ≥ 5 times a month. In this study, for a participant to be considered vaccinated, they needed to have received at least one dose of vaccine by August 31st, 2021.
13th Apr 2022 - News-Medical.Net

CDC study highlights effectiveness of COVID-19 booster vaccination against reinfection and hospitalization

SARS-CoV-2, the causative pathogen of COVID-19 pandemic, is a deadly member of the human beta-coronavirus family. The virus has so far caused more than 497 million infections and 6.1 million deaths worldwide. Among various variants of SARS-CoV-2, the most recently emerged omicron variant has been found to have high immune evasion ability, leading to a global rise in breakthrough infections. There is real-world evidence indicating that previous SARS-CoV-2 infection could provide 90% protection against reinfection and related hospitalization. However, because of the immune evasion potency of the omicron variant, a considerable reduction in infection-mediated protection has been observed globally during the omicron-dominated wave. In the current study, the scientists have estimated the effectiveness of mRNA-based COVID-19 vaccines in providing protection against reinfection-related hospitalization among previously infected adult individuals.
13th Apr 2022 - News-Medical.Net

Researchers developing Covid vaccine for immunocompromised people

A couple months before the pandemic started, Joseph Ford started experiencing a rash of pinpoint polka dots around his lips, ankles, and lower legs. They were itchy, inflamed, painful, and, for him, the first signs of non-Hodgkin lymphoma. “Petechiae,” he explained. Just as he was starting to deal with that, Covid-19 changed the world. “Go home and stay there,” Ford, a 77-year-old retired librarian in Tumwater, Wash., recalled a physician telling him as Covid hollowed out society. “You won’t survive a Covid infection.” That advice has largely remained unchanged over the last two years for the millions who, like Ford, are immunocompromised and haven’t produced adequate — or any — antibodies from the Covid-19 vaccines. But researchers at the University Hospital Tübingen are designing a vaccine to elicit a deeper T cell response than the currently approved vaccines by targeting several key points on viral proteins — epitopes — that are good at stirring up immune T cells.
13th Apr 2022 - STAT News

Nanoparticles could enable a more sensitive and durable rapid COVID-19 test

Rapid antigen tests can quickly and conveniently tell a person that they are positive for COVID-19. However, because antibody-based tests aren't very sensitive, they can fail to detect early infections with low viral loads. Now, researchers reporting in ACS Sensors have developed a rapid test that uses molecularly imprinted polymer nanoparticles, rather than antibodies, to detect SARS-CoV-2. The new test is more sensitive and works under more extreme conditions than antibody-based tests. The gold standard test for COVID-19 diagnosis remains the reverse transcription-polymerase chain reaction (RT-PCR). Although this test is highly sensitive and specific, it generally takes 1-2 days to get a result, is expensive and requires special lab equipment and trained personnel.
13th Apr 2022 - Phys.org

Global COVID-19 decline ‘should be interpreted with caution’: WHO

The number of new COVID-19 cases and deaths reported to the World Health Organization fell for a third consecutive week, a trend likely helped by the dismantling of testing and surveillance programs. In its latest weekly report on the pandemic, issued late Tuesday, the UN health agency said the more than seven million new cases reported represented a 24 per cent decline from a week earlier. The weekly worldwide number of COVID-19 deaths, was down 18 per cent at over 22,000.
13th Apr 2022 - Global News

Convalescent plasma use reduces hospitalisation in unvaccinated COVID-19 patients

Convalescent plasma use in people unvaccinated against COVID-19 significantly reduced the need for hospitalisation due to disease progression, according to a US study. Convalescent plasma (CP) use in people unvaccinated against COVID-19 within 9 days of symptom onset, led to a significant reduction in the proportion of individuals requiring hospital admission due to disease progression. This was the conclusion of a randomised, double-blind, controlled trial by a multidisciplinary group of researchers from New York, US.
13th Apr 2022 - Hospital Healthcare Europe

Estimate: Less than half the world has had COVID-19

From March 2020 to the emergence of the Omicron variant in late 2021, about 3.8 billion COVID-19 infections and reinfections occurred, with nearly 44% of the world's population infected at least once but with wide regional variations, estimates a statistical analysis of 190 countries and territories published late last week in The Lancet. Led by Institute for Health Metrics and Evaluation researchers, the COVID-19 Cumulative Infection Collaborators created and refined statistical models of global and location-specific daily and cumulative COVID-19 infections using data from Johns Hopkins University, national databases, and seroprevalence surveys, adjusting for lags in reporting, undercounting of deaths, waning antibody sensitivity, vaccinations, and reinfection by SARS-CoV-2 variants.
13th Apr 2022 - CIDRAP

Vaccines have halved Italy's COVID-19 death toll, study shows

Vaccines against COVID-19 have roughly halved the death toll from the disease in Italy, preventing some 150,000 fatalities and 8 million cases last year, the National Health Institute (ISS) estimated on Wednesday. The ISS study, which ran from the start of 2021 until the end of January this year, concluded the inoculation campaign also prevented more than 500,000 hospitalisations and over 55,000 admissions to intensive care. Italy has registered 161,032 deaths linked to COVID-19 since its outbreak emerged in February 2020, the second-highest toll in Europe after Britain and the eighth highest in the world.
13th Apr 2022 - Reuters

COVID-19, overdoses pushed US to highest death total ever

2021 was the deadliest year in U.S. history, and new data and research are offering more insights into how it got that bad. The main reason for the increase in deaths? COVID-19, said Robert Anderson, who oversees the Centers for Disease Control and Prevention’s work on death statistics. The agency this month quietly updated its provisional death tally. It showed there were 3.465 million deaths last year, or about 80,000 more than 2020′s record-setting total. Early last year, some experts were optimistic that 2021 would not be as bad as the first year of the pandemic — partly because effective COVID-19 vaccines had finally become available. “We were wrong, unfortunately,” said Noreen Goldman, a Princeton University researcher.
13th Apr 2022 - The Associated Press

Shanghai releases more from virus observation amid lockdown

Shanghai released 6,000 more people from the central facilities where they were under medical observation to guard against the coronavirus, the government said Wednesday, though the lockdown of most of China’s largest city was continuing in its third week. About 6.6 million people in the city of 25 million were allowed to leave their homes Tuesday, but some were restricted to their own neighborhoods. Some housing compounds also appeared to still be keeping residents locked inside, and no further lifting of restrictions was apparent Wednesday. Officials warn that Shanghai still doesn’t have its latest surge in cases of the omicron variant under control, despite its “zero-tolerance” approach that has seen some residents confined to their homes for three weeks or longer.
13th Apr 2022 - The Associated Press

FDA slaps another hold on Ocugen, Bharat's COVID vaccine after WHO flags manufacturing problems

In April of last year—soon after receiving a $200 million government grant from India to beef up its manufacturing capacity—Bharat Biotech proclaimed an ambitious goal to produce 700 million COVID-19 vaccines annually. Reaching that figure won’t be easy in the near future considering the regulatory setbacks Bharat and its U.S. commercial partner Ocugen have faced. The most recent came this week when the FDA put a clinical hold on an immuno-bridging study by Ocugen designed to show that Bharat’s vaccine could protect people in the U.S. as effectively as it has done in trials in India.
12th Apr 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Apr 2022

View this newsletter in full

COVID-19 household transmission is high, with children being a significant source of spread, study finds

A study released today indicates that SARS-CoV-2 (the virus that causes COVID-19) spreads extensively in households, with children being a significant source of that spread. Approximately 50% of household members were infected from the first-infected individual during the study period. Although kids were less likely to spread the virus compared to adults, children and adults were equally likely to become infected from the first-infected individual.
12th Apr 2022 - Science Daily

Covid-19 testing in the UK was not a “shambles” in 2020

In a recent interview with The BMJ, Paul Nurse said that covid-19 PCR testing in the UK in 2020 was a shambles.1 I respond as someone who volunteered to help set up the Milton Keynes Lighthouse testing laboratory. I agree with Nurse that in 2020 the government should have used academic laboratories to ramp up covid PCR testing capacity
12th Apr 2022 - The BMJ

Researchers outline need for new approach to COVID-19 vaccine testing

The commentary by bioethicist Nir Eyal and epidemiologists Tobias Gerhard and Brian Strom (the latter is chancellor of Rutgers Biomedical and Health Sciences) – published in Pharmacoepidemiology and Drug Safety – examines how this parallel approach to vaccine trials can lead to faster and more accurate vaccine assessment and more effective pandemic response. The researchers say that further vaccine testing could help settle remaining questions about how effective the shots are at blocking infection against old and new virus strains. It could also reveal the most effective dosing and timing between shots, the level of protection compared to natural immunity and how well vaccines work in groups that were underrepresented in initial trials. While some researchers proposed at the beginning of the COVID-19 pandemic that challenge trials take place, others argued that too little was known about the virus and that conducting the trials would be too dangerous. They were not used for the studies that led to approval of the major COVID-19 vaccines but are now being used in testing.
12th Apr 2022 - EurekAlert!

Thai FDA grants EUA to Novavax-Serum Institute's Covid-19 vaccine

The Thailand Food and Drug Administration (Thai FDA) has granted emergency use authorization (EUA) to Novavax and Serum Institute of India for a protein-based Covid-19 vaccine, NVX-CoV2373. Created from the genetic sequence of the initial SARS-CoV-2 virus strain, the vaccine is formulated with Novavax’s saponin-based Matrix-M adjuvant. The vaccine is authorised for active immunisation for preventing Covid-19 in adults aged 18 years and above. SII will produce and supply the vaccine under the brand name Covovax.
12th Apr 2022 - Pharmaceutical Technology

RedHill pill shows promise vs Omicron; mRNA vaccines appear effective in those with well-controlled HIV

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Experimental pill shows promise against Omicron An experimental drug being developed by RedHill Biopharma Ltd that improved outcomes in a randomized trial involving severely ill COVID-19 patients infected with earlier versions of the coronavirus is showing promise against the Omicron variant in test tube experiments, researchers said.
12th Apr 2022 - Euronews

Nanocell COVID-19 vaccine elicits potent neutralizing response

As of April 11, 2022, SARS-CoV-2 infection has caused over 6.2 million deaths. In response to the outbreak of SARS-CoV-2, many vaccines were rolled out at unprecedented speed. However, the continued emergence of highly transmissible immune escape variants has limited efforts to reduce the spread of SARS-CoV-2 and end the current pandemic. Large-scale administration of the most effective vaccines against the coronavirus disease 2019 (COVID-19) has been challenging due to the ultra-cold storage conditions required for nucleic acid vaccines at -20 oC to -70 oC, as well as their short shelf life. Nanocells are about 400 nanometers (nm) in diameter, lack chromosomes, and are called EnGeneIC Dream Vector (EDVTM). EDV is a derivative of a mutant bacterium of the species Salmonella typhimurium that is developed through budding caused by the mutation. Earlier EDVs are currently being investigated in early clinical trials for their ability to deliver anti-cancer therapy to solid cancers. These trials have elicited promising results including the arrest of cancer growth, increased survival, and low or no toxicity.
12th Apr 2022 - News-Medical.Net

Heart inflammation after Covid vaccine ‘no more common than after other jabs’

Heart inflammation after a Covid jab is not only rare but no more common than after other types of vaccinations, researchers have found. As Covid vaccination programmes began around the world it emerged that some people – particularly young men – subsequently developed myocarditis, a type of inflammation of the heart muscle, or pericarditis, inflammation of the outer lining of the heart. While cases were rare, the findings caused concern, with risk of such heart inflammation among the reasons cited by experts in the UK for the delay in expanding the vaccination programme to children. Now research suggests that myopericarditis – an umbrella term that encompasses myocarditis and pericarditis – is not only uncommon after Covid jabs, but the risk of developing it is no greater than that posed by other types of inoculations, such as flu vaccinations.
12th Apr 2022 - The Guardian

New Drug Slashed Deaths Among Patients With Severe Covid, Maker Claims

About half of the 52 trial participants given a placebo or dummy pill along with regular care died within 60 days, an indicator of how very sick they were. But the death rate was 20 percent among the 98 participants who received sabizabulin, who were just as ill. The drug was given once a day for up to 21 days. “Sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients,” Dr. Mitchell Steiner, chief executive of Veru, said. “This represents a big step forward.”
12th Apr 2022 - The New York Times

What do we know about “stealth omicron” so far?

What do we know about “stealth omicron” so far? It’s an extra-contagious version of the omicron variant, but it doesn’t seem to cause more severe disease. Since it was first identified in November, BA.2 has been spreading around the globe, driving new surges in parts of Asia and Europe. It’s now the dominant coronavirus version in the U.S. and more than five dozen other countries. It was given the “stealth” nickname because it looks like the earlier delta variant on certain PCR tests, says Kristen Coleman at the University of Maryland School of Public Health. The original omicron, by contrast, is easy to differentiate from delta because of a genetic quirk. In rare cases, early research indicates BA.2 can infect people even if they’ve already had an omicron infection. COVID-19 vaccines appear just as effective against both kinds of omicron, offering strong protection against severe illness and death.
12th Apr 2022 - The Associated Press

Pfizer's COVID pill Paxlovid gets boost in Britain thanks to spot in national trial

Pfizer’s COVID-19 vaccine and antiviral show little sign of slowing down in the pandemic’s third year. Now, the company’s oral therapy is getting a boost across the Atlantic. Thousands more people in the U.K. will gain access to Pfizer’s Paxlovid thanks to its inclusion in the national Panoramic study, which is looking at how best to use the pill among Britain’s highly vaccinated population, the country’s Department of Health and Social Care said Tuesday. Paxlovid is the second antiviral to enter the Panoramic fray behind Merck & Co. and Ridgeback Biotherapeutics’ molnupiravir, Britain’s health ministry pointed out. The drug has been shown to slash the risk of hospitalization or death by 88% in clinical studies, and it’s already available in the U.K. for patients with
12th Apr 2022 - FiercePharma

Moderna recalls vaccine batch after foreign substance found in CDMO-made vial—again

The specter of particulates has forced another recall—this time on Moderna’s massively successful COVID-19 vaccine Spikevax—and the latest pull isn’t contract manufacturer Rovi’s first brush with contamination, either. Moderna on Friday said it was recalling one Spikevax lot in Europe. The batch contains 764,900 doses made by CDMO Rovi that were deployed across Norway, Poland, Portugal, Spain and Sweden between Jan. 13 and Jan. 14. Moderna yanked the shots because of a “foreign body” found in one vial of the batch made at Rovi’s site in Spain, the partners said in a release. The suspect vial was punctured but not administered, the companies added. Moderna and Rovi learned about the contamination issue from a vaccination center in Málaga, Spain. The tainted vial was “returned for forensic assessment and investigation,” the companies noted.
12th Apr 2022 - FiercePharma

Even mild COVID-19 raises the risk of blood clots

A new nationwide study conducted in Sweden reports that individuals with COVID-19 were at greater risk of developing a blood clot at least up to 3 months after the infection. Although individuals hospitalized with severe COVID-19 were at the highest risk of developing blood clots, even those with mild COVID-19 were at increased risk of blood clots. The study highlights the importance of treatments to reduce blood clots, especially in high risk COVID-19 patients, and vaccination against COVID-19.
12th Apr 2022 - Medical News Today

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Apr 2022

View this newsletter in full

Ministry of Health announces third death linked to Covid-19 vaccine

The Ministry of Health has been notified of a third death the Vaccine Independent Safety Monitoring Board considered to be linked to the Pfizer Covid-19 vaccine. The individual had myocarditis at the time of their death in December 2021. However, at the time, there was not enough information available to determine the potential role of the vaccine. In the weeks prior to their death, the individual had received a dose of the Pfizer Covid-19 vaccine. The Board said the development of myocarditis was possibly due to vaccination with the Pfizer Covid-19 vaccine, however, it does not impact or change the known information on myocarditis. Covid-19 is more likely to cause myocarditis than the vaccine, and the risk of Covid-19 far outweighs the risk of the vaccine. Of Kiwis aged 12 and older, 95 per cent have had two doses of the Covid vaccine, according to data from the Ministry of Health.
11th Apr 2022 - Stuff.co.nz

Catalonia's Hipra Covid-19 vaccine could be on the market by June

The Covid-19 vaccine made by Catalan pharmaceutical company Hipra, which was found to generate more antibodies than the Pfizer jab, could be placed on the market by late May or early June, Spain's science minister Diana Morant said on Monday in an interview with public broadcaster TV3. The European Medicines Agency is currently conducting a rolling review of the protein-based vaccine that is intended to be used as a booster for adults who have already been fully vaccinated with other jabs. "Hipra is an example of a successful public-private partnership," Morant said. The Spanish government allocated €18 million towards its development. "We wish Hipra a lot of success with their vaccine that has many advantages over others that we've already been inoculated with," she added.
11th Apr 2022 - Catalan News

Covid nasal spray could replace vaccine jabs as scientists rethink fight against virus

As the omicron variant of the coronavirus moved lightning-fast around the world, it revealed an unsettling truth. The virus had gained a stunning ability to infect people, jumping from one person’s nose to the next. Cases soared this winter, even among vaccinated people. That is leading scientists to rethink their strategy about the best way to fight future variants, by aiming for a higher level of protection: blocking infections altogether. If they succeed, the next vaccine could be a nasal spray. The original coronavirus shots proved remarkably versatile, protecting people from the worst outcomes of Covid-19.
11th Apr 2022 - The Independent

Moderna and Rovi Pharma recall Covid-19 vaccine doses

Moderna and Rovi Pharma have recalled a batch of 764,900 doses of the Moderna Covid-19 vaccine, Spikevax. The move comes after a foreign body was detected in one of the vials from the batch produced at Rovi’s contract manufacturing site in Spain. The company noted that the contaminated vial was punctured and was not used for administration to people. Moderna’s marketing authorisation holders Moderna Biotech Spain and Rovi were informed of the issue through a complaint on the product from an inoculation centre in Málaga, Spain.
11th Apr 2022 - Pharmaceutical Technology

Heart issues after COVID-19 uncommon in children and young adults, more research needed

Heart complications are uncommon, yet treatable for children and young adults after COVID-19 disease or SARS-CoV-2 infection, according to a new scientific statement from the American Heart Association that details what has been learned about how to treat, manage and even prevent cardiovascular complications from the SARS-CoV-2 virus in youth. The statement published today in the Association's flagship journal Circulation. The latest data also indicate returning to sports and strenuous physical activities after heart symptoms resolve is safe, though additional screening may be considered for youth who experience more severe symptoms.
11th Apr 2022 - Medical Xpress

WHO says it is analysing two new Omicron COVID sub-variants

The World Health Organization said on Monday it is tracking a few dozen cases of two new sub-variants of the highly transmissible Omicron strain of the coronavirus to assess whether they are more infectious or dangerous. It has added BA.4 and BA.5, sister variants of the original BA.1 Omicron variant, to its list for monitoring. It is already tracking BA.1 and BA.2 - now globally dominant - as well as BA.1.1 and BA.3. The WHO said it had begun tracking them because of their "additional mutations that need to be further studied to understand their impact on immune escape potential".
11th Apr 2022 - Reuters

GlaxoSmithKline, CureVac and BioNTech clinch German pandemic preparedness contracts

As CureVac and GlaxoSmithKline mulligan with a second-generation COVID-19 vaccine, the partners have signed on for a German pandemic contingency plan to earmark mRNA production capacity for years to come. The contract with the German federal government will see GSK and CureVac supply mRNA vaccines “within a broader tender for pandemic preparedness in Germany." After a maximum two-year setup period, the companies will provide the German government with access to CureVac’s manufacturing capacity until 2029. Under the deal, CureVac and GSK will be able to swiftly deploy 80 million mRNA shot doses annually “during the remainder of the current pandemic or in future infectious disease outbreaks,” the partners said in a release Monday. The move seeks to counter the sort of supply bottlenecks that were commonplace in the pandemic’s early days, the partners added. With GSK and Curevac’s mRNA muscle on retainer, Germany will pay the partners an annual standby fee, following successful setup, which entails maintaining production capacity “at constant readiness.”
11th Apr 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Apr 2022

View this newsletter in full

Study finds U.S. COVID-19 vaccinations averted 2.2 million deaths

A new study published Friday found COVID-19 vaccinations have prevented 2.2 million deaths in the United States. The Commonwealth Fund study said 17 million hospitalizations were averted by the vaccines between December 12, 2020, and March 31, 2022. More than $899 billion was saved in healthcare costs due to the vaccines, according to the Commonwealth Fund study. The study found there would have been 66 million more COVID-19 infections without the vaccinations.
10th Apr 2022 - UPI.com

COVID: Vulnerable coronavirus patients getting at-home treatment which improves symptoms 'within hours'

More than 32,000 vulnerable COVID patients in England have been treated with "cutting-edge" antiviral drugs which improve symptoms "within hours", the NHS has said. The health service has procured nearly five million doses of Pfizer's Paxlovid and other antivirals, such as Molnupiravir, via a deal struck by the government. Paxlovid was found in trials to cut coronavirus hospital admissions and deaths by 88% and has been given to more than 6,000 patients already - 1,400 in the last seven days alone. Molnupiravir, which clinical trials suggest reduces the risk of hospital admission or death by 30%, was approved in November 2021 and has been used as an at-home treatment since December.
9th Apr 2022 - Sky News

Long COVID-19 research has Busselton baby boomers helping scientists understand virus's effects

As researchers around the world try to determine the long-term impacts of COVID-19, data from a regional community in Western Australia is helping unravel the mystery of the virus. The City of Busselton is not just home to the iconic timber jetty. It's also home to the Busselton Population Medical Research Institute, which holds some of the most detailed community-health data in Australia. For more than a decade, Busselton researchers have been taking samples and running health checks on volunteer baby boomers at different stages of their lives, to help identify chronic-disease patterns and risk factors.
9th Apr 2022 - ABC News

More COVID-19 boosters are in our future. An immunologist explains why

Most vaccines don't create what we call sterilizing immunity, which means that you absolutely never carry that virus ever again. Your body does not carry it. So if we think about the ones that do — measles would be a good example — but most [vaccines] don't. So to level set our expectations, it's not normal for a vaccine to be able to completely train the immune system in such a way that virus doesn't even get a start. And, as a consequence, even if you are vaccinated —and we're certainly seeing this in the context of Omicron — you can still get the virus, carry the virus and pass on the virus. Certainly if everyone was vaccinated and totally up to date on their vaccination, the frequency with which carrying that and transmitting it happens is lower. But we should set our expectations to something reasonable.
9th Apr 2022 - CBC.ca

In Washington's Covid-19 outbreak, new variants flout old 'close contact' rule

Washington, DC is coping with a cluster of high-profile Covid-19 cases after a series of public events exposed high-level officials. House Speaker Nancy Pelosi, Sens. Susan Collins and Raphael Warnock, and Rep. Peter DeFazio have all this week announced that they tested positive. Health experts say the outbreak may be rooted, in part, in outdated and confusing guidelines from the US Centers for Disease Control and Prevention that help people assess their risk of getting the virus that causes Covid-19 or passing it on to others.
9th Apr 2022 - CNN

Omicron spawns U.S. search for better kids' masks, new standard

The fast-spreading Omicron variant stoked U.S. interest in better masks for children to ward off COVID-19, and that is adding fuel to an effort that could set the stage for domestic oversight of their quality.
9th Apr 2022 - Reuters

In Early Testing, Nasal Spray Shows Signs It Can Fight COVID-19

Over two years into the pandemic, researchers are still searching for new and better ways to help people avoid COVID-19. While COVID-19 vaccines and boosters have been helpful at protecting people from severe hospitalization and death, they have been less effective at preventing symptomatic cases of the disease. Now researchers are looking at novel ways to keep COVID-19 from infecting human cells. ResearchersTrusted Source at Cornell University have been testing a nasal spray that blocks COVID-19 infection. Their study discovered a small molecule that, if sprayed into the nose, may help prevent COVID-19 from infecting cells. The study is still in its early stages and is currently only being tested in mice. But experts are hopeful that this type of study may help lead to better protection against the virus.
9th Apr 2022 - Healthline

Pfizer Covid-19 booster shots approved for children aged 12-15 by Therapeutic Goods Administration

Australia's medical regulator has given approval for 12 to 15-year-olds to receive a COVID-19 booster. The Therapeutic Goods Administration gave provisional approval for people in the Year 7 to 10 age range to receive the Pfizer booster. A final green light will need to be given by the Australian Technical Advisory Group on Immunisation before the boosters can be rolled out to them. The medical regulator has recommended the booster be given six months after the primary course of a COVID-19 vaccine.
9th Apr 2022 - Daily Mail

COVID-19: Damage to heart's pacemaker cells may explain arrhythmia

A new studyTrusted Source exploring the link between SARS-CoV-2 infection and irregularities in heart rate and rhythm (arrhythmia) is shedding light on how the virus causes disruption in the body’s cardiovascular system. The research, reported in the journal Circulation Research, explores recent findings that heart abnormalities are a common symptom of COVID-19 and could be a consequence of SARS-CoV-2 affecting the specialized pacemaker cells of the heart. The research was carried out by a team from Weill Cornell Medicine in New York City, which included Shuibing Chen, Ph.D., associate professor of surgery, chemical biology, and biochemistry; Robert Schwartz, MD, Ph.D., assistant professor of medicine; and Todd Evans, Ph.D., professor and vice-chair for research, in addition to Benjamin tenOever, Ph.D., a faculty member at the Grossman School of Medicine and NYU Langone Health at New York University.
9th Apr 2022 - Medical News Today

Women in healthcare and life sciences: The ongoing stress of COVID-19

The COVID-19 pandemic has created a seismic shift in the workforce, with a specific impact on women. Millions of Americans have resigned from their jobs, and many have cited unmanageable workloads or a need to care for family as important factors in their decision. The healthcare sector is no exception. Our most recent analysis is based on the seventh annual Women in the Workplace data (for 2021), by McKinsey and LeanIn.Org. That research looks at drop-offs in female representation, promotion rates, and external hiring at the highest levels in healthcare; at the barriers to advancement for women of color and at threats to recent gains. In many cases, these outcomes are correlated with the effects of the COVID-19 pandemic, including reports of increased responsibilities at home and higher levels of burnout.
9th Apr 2022 - McKinsey

ECDC and EMA Issue Advice on Fourth Doses of mRNA COVID-19 Vaccines

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population. The European Centre for Disease Prevention and Control (ECDC) and the European Medicine Agency’s (EMA’s) COVID-19 task force (ETC) have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population. The vaccines being referred to are Pfizer’s Comirnaty and Moderna’s Spikevax. ECDC and EMA concluded that there is currently no clear evidence in the European Union that adults with normal immune systems will benefit from a fourth dose. However, in adults aged 80 years and older, the agencies agreed that a fourth dose may be administered for the protection against COVID-19. There may be a reevaluation of recommending a fourth dose for adults aged 60 to 79 years depending on the epidemiological situation changes and new data. As of now, there is no clear evidence that the current three-dose vaccination system is decreasing in effectiveness for this age group.
9th Apr 2022 - BioPharm International

Board: Physician-legislator's COVID directive has no weight

The Kansas board that licenses health care providers raised concerns Friday about a letter that a physician-legislator sent to doctors suggesting that they prescribe ivermectin and other medications that aren’t approved to treat the virus. The Kansas Board of Healing Arts said that the “unprecedented” letter from Kansas Sen. Mark Steffen carried no legal or regulatory weight but has caused “confusion and concern” in the Kansas medical community, The Kansas City Star reports. Steffen, who is an anesthesiologist, said that health care providers will be shielded from the board’s “interference” in the letter that he sent last week on Senate stationery. The Hutchinson Republican said previously that the board is investigating him.
9th Apr 2022 - The Associated Press

COVID-19: Omicron symptoms less severe than Delta variant, study concludes

The research concluded that those with Omicron were less likely to be admitted to hospital and lose their sense of smell than people with Delta. Symptoms do not tend to last as long in vaccinated individuals with the current dominant variant than in people with Delta, at 6.87 days versus 8.89 days. The findings support earlier studies that suggest the incubation time and period of infectiousness for Omicron is shorter than for previous COVID strains. Research showed that the loss of sense of smell appeared in 52.7% of Delta cases, while it showed up in less than 20% of Omicron cases - marking the biggest difference between the two.
9th Apr 2022 - Sky News

Study sheds light on death spike in Hong Kong COVID-19 surge

Hong Kong's surge began in early January with a cluster of Omicron infections in a quarantine hotel. Its fifth wave peaked on Mar 4, along with a mortality rate of 37.7 per million population that was among the highest in the world during the pandemic. Officials reported 5,906 deaths as of Mar 21 during the Omicron surge. Of eligible people in Hong Kong, 64% had received at least two vaccube doses and 5% had gotten a booster dose, but coverage varied by age. Only 49% of people ages 60 and older had gotten at least two doses, with coverage declining as people got older. Among the deaths, 96% occurred in people ages 60 and older, and of those 70% were unvaccinated. "The high overall mortality rate during the ongoing 2022 Hong Kong Omicron COVID-19 outbreak is being driven by deaths among unvaccinated persons aged ≥60 years," the team wrote. In weighing other factors, the team compared Hong Kong's surge with New Zealand, which has a lower population density but, like Hong Kong, was thought to largely have vaccine-induced immunity due to vaccination combined with low infection levels during earlier waves.
8th Apr 2022 - CIDRAP

Shanghai's high asymptomatic COVID rate could be due to including mild cases

Shanghai's unusually high proportion of asymptomatic cases among its reported COVID-19 infections could be partly explained by blurred lines between "mildly symptomatic" and asymptomatic cases. Authorities in China's financial centre ordered a lockdown in response to the worst outbreak in the country since the virus first emerged in Wuhan in late 2019. Shanghai counted more than 20,000 new cases on April 7, but the asymptomatic rate has stood at around 97%, far higher than anywhere else in the world, where it has been closer to 50%.
8th Apr 2022 - Reuters

Moderna recalls thousands of COVID vaccine doses in Europe

Moderna Inc said on Friday it was recalling 764,900 doses of its COVID-19 vaccine made by its contract manufacturer Rovi (ROVI.MC) after a vial was found contaminated by a foreign body. No safety issues have been identified, Moderna said about the lots that were distributed in Norway, Poland, Portugal, Spain and Sweden in January. The drugmaker said the contamination was found in just one vial, and it was recalling the whole lot out of "an abundance of caution". It did not disclose what was found in the vial.
8th Apr 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Apr 2022

View this newsletter in full

EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The European Medicines Agency’s (EMA) COVID-19 task force (ETF) has decided not to recommend a fourth COVID-19 vaccine dose for the general population of the EU at this time. This decision was made in conjunction with the European Centre for Disease Prevention and Control (ECDC). The fourth doses that were being considered are Pfizer’s Comirnaty and Moderna’s Spikevax – both mRNA COVID-19 vaccines. However, both agencies agreed that adults aged 80 years and above can be given a fourth dose – or second booster – following data reviews. These reviews would evaluate the higher risk of severe COVID-19 in this particular age group and the protection benefits offered from a fourth dose
7th Apr 2022 - PMLiVE

Study finds vaccines effectively reduce deaths from COVID-19 but not the prevalence of infections

Researchers in Australia have investigated coronavirus disease 2019 (COVID-19) vaccine effectiveness on the prevalence and mortality of the Delta variant. They found that countries with more vaccine coverage suffer from less mortality. However, the case numbers remain high, eventually leading to outbreaks. The team attributes the scenario to the fact that the countries with more vaccine coverage are at the same time the most vulnerable to COVID-19 infection.
7th Apr 2022 - News-Medical.Net

An assessment of COVID-19 vaccine safety during pregnancy

In a recent study posted to the Preprints with The Lancet* SSRN preprint server, researchers evaluated the safety of currently administered coronavirus disease 2019 (COVID-19) vaccines in child-bearing women. The distinct physiological changes in the cardiopulmonary and immune systems occurring in pregnancy increase the susceptibility of pregnant women to severe outcomes [intensive care unit (ICU) admissions and ventilation requirements) following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. However, the safety data of SARS-CoV-2 vaccines during pregnancy is lacking and needs to be further evaluated to guide advisory and public committees and aid in developing health policies.
7th Apr 2022 - News-Medical.Net

COVID vaccine plus infection can lead to months of immunity

Even people who have had COVID-19 receive long-lasting benefits from a full course of vaccination, according to three recent studies1–3. What's more, one of the studies3 found that the ‘hybrid’ immunity caused by vaccination and infection is long-lasting, conferring highly effective protection against symptomatic disease for at least six to eight months after vaccination. The data were collected before the Omicron variant emerged, casting some doubt on the studies’ relevance today. But if the findings hold up, they could inform vaccination schemes and vaccine passports, which some countries require for entry to places such as restaurants. The work also counters high-profile claims that people who have had COVID-19 don’t benefit from vaccination.
7th Apr 2022 - Nature

No evidence to support widespread use of fourth COVID shot - EU agencies

EU health agencies said on Wednesday there was no evidence to support the use of a fourth dose of COVID-19 vaccines developed by Pfizer (PFE.N) and Moderna (MRNA.O) in the general population, but they recommend a second booster for people aged 80 and above. There is no clear evidence in the European Union that vaccine protection against severe disease is waning substantially in adults with normal immune systems aged 60-79, the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) said in a joint statement.
7th Apr 2022 - Reuters

U.S. FDA aims to decide on strain selection for COVID boosters by June

Top U.S. Food and Drug Administration officials on Wednesday said the agency is aiming to decide by June whether to change the design of COVID-19 vaccines in order to combat future variants, even if it does not have all the necessary information to measure their effectiveness. "We're going to have to think about this in a way that is less than optimal because we're not going to have all the data that we'd like to have," Peter Marks, director of FDA's Center for Biologics Evaluation and Research, said at a meeting of the agency's scientific advisers to discuss the issue.
7th Apr 2022 - Reuters

Covid-19 Variant Strategy for Long Haul Is Needed, FDA Official Says

A top U.S. health regulator said that asking people to frequently get Covid-19 boosters wasn’t sustainable because of vaccine fatigue and that authorities needed to develop a long-term strategy for protecting the public from the virus as it evolves. Dr. Peter Marks, who heads the Food and Drug Administration’s vaccines division, said that last week’s authorization of a second booster dose for people 50 years and older and for people 12 and older with weakened immune systems was a stopgap. “This is really trying to do the best we can with the knowledge we have at hand, which is something that we’ve had to do a fair amount of over the past two years as a public-health agency,” Dr. Marks on Wednesday told vaccine experts advising the agency.
7th Apr 2022 - The Wall Street Journal

US experts wrestle with how to update COVID-19 vaccines

More than two years into the COVID-19 pandemic, U.S. health officials are beginning to grapple with how to keep the vaccines updated to best protect Americans from the ever-changing coronavirus. On Wednesday, a panel of vaccine advisers to the Food and Drug Administration spent hours debating key questions for revamping the shots and conducting future booster campaigns. They didn’t reach any firm conclusions. The questions facing the experts included: How often to update the vaccines against new strains, how effective they should be to warrant approval and whether updates should be coordinated with global health authorities. Last week, the FDA authorized a fourth dose of the Pfizer or Moderna vaccines for anyone 50 or older and for some younger people with severely weakened immune systems. It’s an effort to get ahead of another possible surge.
7th Apr 2022 - The Associated Press

A seasonal COVID-19 booster shot? Don't count on it in the U.S. or Europe

People in the U.S. and Europe hoping to receive COVID-19 vaccine booster shots every four to six months are in for a rude awakening. On Wednesday, experts on both sides of the Atlantic tossed cold water on the idea of seasonal boosting. In Europe, regulators concluded that it is too early to consider allowing a fourth dose of the Pfizer-BioNTech or Moderna vaccine. Meanwhile in the U.S., a panel of experts has directed the FDA to devise a plan for annual boosting against COVID-19.
7th Apr 2022 - Fiercepharma

COVID-19 health workers suffer combat-type moral trauma

A Duke University study shows that, amid COVID-19, US healthcare workers (HCWs) had similar rates of potential moral injury (PMI)—a type of trauma-induced wound to the psyche—as military combat veterans. The study, published yesterday in the Journal of General Internal Medicine, surveyed 2,099 HCWs in 2020 and 2021 and 618 military veterans deployed to a combat zone after the Sep 11, 2001, US terrorist attacks about PMIs they may have experienced. PMI is a distressing reaction to exposure to traumatic events that may have psychological, behavioral, social, and spiritual effects.
6th Apr 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Apr 2022

View this newsletter in full

Rare vaccine-related blood clots tied to gene; concentrated antibodies may help the immunosuppressed

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Vaccine-related blood clots tied to gene, antibody variants. New research may help shed light on a rare but serious blood-clotting problem associated with the COVID-19 vaccines from AstraZeneca and Johnson & Johnson . Five unrelated people with this clotting complication, known as vaccine-induced thrombotic thrombocytopenia, all had unusually-structured antibodies against a protein called PF4 that is involved in blood clotting, the researchers found.
6th Apr 2022 - Reuters

U.S. FDA aims to decide on strain selection for COVID boosters by June

Study: Newly developed COVID vaccine from Aus

The SARS-CoV-2 subunit vaccine (PreS-RBD) developed at MedUni Vienna is based on a structurally folded fusion protein consisting of two receptor binding domains (RBD) of the SARS-CoV-2 virus and the PreS antigen from hepatitis B, which serve as immunological carriers for each other, thereby strengthening the immune response. Currently available genetic SARS-CoV-2 vaccines induce mainly transient IgG1 antibody responses, whereas the PreS-RBD vaccine can additionally induce long-lived RBD-specific IgG4 antibodies. PreS-RBD-specific IgG antibodies detected in blood and mucosal secretions reacted with SARS-CoV-2 variants, including the omicron variant. Antibodies induced by vaccination with PreS-RBD more potently inhibited the binding of RBD with its human receptor ACE2, and their virus-neutralizing titers were higher than those in a random sample of individuals fully immunized with two vaccinations of currently registered vaccines or than those of COVID-19 convalescents (i.e., individuals who had previously had COVID-19).
6th Apr 2022 - EurekAlert

Protection against infection offered by fourth Covid-19 vaccine dose wanes quickly, Israeli study finds

A fourth dose of the Pfizer/BioNTech Covid-19 vaccine seems to offer short-lived protection against infection overall, but protection against severe illness did not wane for at least several weeks, according to a new study. The study, published Tuesday in the New England Journal of Medicine, looked at the health records of more than 1.25 million vaccinated people in Israel who were 60 or older from January through March 2022, a time when the Omicron coronavirus variant was the dominant strain.
6th Apr 2022 - CNN

FDA suspends use of GSK-Vir's sotrovimab for Covid-19 treatment in US

The US Food and Drug Administration (FDA) has updated the emergency use authorization (EUA) for GlaxoSmithKline (GSK) and Vir Biotechnology’s sotrovimab and suspended its use to treat Covid-19. Sotrovimab is an investigational monoclonal antibody that binds to the epitope of the SARS-CoV-2 virus to neutralise it. The regulatory authority noted that the antibody is unlikely to be effective against the Omicron BA.2 sub-variant, which is causing a rise in the number of Covid-19 cases in the region. The proportion of the sub-variant-caused Covid-19 cases is more than 50% in all Health and Human Services (HHS) US regions, the Centers for Disease Control and Prevention (CDC) Nowcast data showed.
6th Apr 2022 - Pharmaceutical Technology

Covid-19: WHO suspends supplies of India's Covaxin through UN agencies

The World Health Organization has suspended the supply of Covaxin through UN procurement agencies because of manufacturing irregularities. Covaxin is India’s indigenous covid-19 vaccine, produced by the Hyderabad based Bharat Biotech. A spokesperson for WHO told The BMJ that the suspension had come after a broader inspection of a few companies in India by the agency. “In the case of Bharat Biotech’s Covaxin manufacturing site, problems were detected in some parts of the manufacturing process, and changes were made after the emergency use listing was granted,” said the spokesperson. “But [these] were not submitted to the national drug regulator and WHO for evaluation and validation. However, the company is fully aware and cooperative.” The move came a day after Bharat Biotech announced that it would be scaling down its production of Covaxin domestically, as demand was dropping and infections were reducing alongside wider immunisation coverage in India. Covaxin received emergency use authorisation from India’s Central Drugs Standard Control Organization in January 2021 and was included in the nationwide immunisation drive.
6th Apr 2022 - The BMJ

Long Covid-19 may remain a chronic condition for millions

Covid-19 has become a chronic condition for tens of millions of people -- and an expensive one, as well. Long Covid -- a condition marked by lingering symptoms that can involve multiple bodily systems -- has cost a cumulative $386 billion in lost wages, savings and medical expenses in the US alone as of January, according to one estimate. On Tuesday, the Biden administration announced that it was making long Covid a national priority. It unveiled a plan to accelerate efforts to prevent, treat and detect long Covid through a national interagency research action program. In February, the National Institutes of Health announced a $1.15 billion initiative to support research into the condition over four years.
6th Apr 2022 - CNN

China's COVID outbreak will improve if existing policies implemented better - expert

"The duration of this epidemic depends on our prevention and control strategies, and how strong we implement our prevention and control measures," said Wu Zunyou, chief epidemiologist at the China Center for Disease Control and Prevention. China's "zero-COVID" stance, known as "dynamic clearance", has come under growing scrutiny in recent weeks after the lockdown of the country's most populous city of Shanghai amid an outbreak of the highly contagious Omicron variant.
6th Apr 2022 - Reuters

FDA pulls authorization for GSK-Vir's COVID therapy as BA.2 cases rise

The U.S. health regulator said on Tuesday GlaxoSmithKline and Vir Biotechnology's antibody therapy was no longer authorized as a COVID-19 treatment, with data suggesting it was unlikely to be effective against the dominant Omicron sub-variant in the country. The move by the agency, which had already pulled its authorization for the sotrovimab therapy in much of the U.S. northeast last month, sent shares in Vir Biotechnology 11.5% lower. The highly contagious BA.2 coronavirus sub-variant is estimated to make up about three of every four COVID-19 cases in the United States, according to the latest government data
6th Apr 2022 - Reuters

Current COVID vaccines not 'well-matched' against BA.2 -FDA

The U.S. Food and Drug Administration said it is aiming to come up with a decision on coronavirus strain selection for the composition of future COVID-19 boosters by June, as a panel of its advisers met on Wednesday to discuss the issue. "We should be thinking of a May to June time frame here," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research, during the meeting, adding that there is some wiggle room. The panel of outside experts was convened to discuss how and whether to use additional vaccine boosters after data from Israel showed a fourth dose lowered rates of severe COVID among older people.
6th Apr 2022 - Reuters

China Kintor's COVID drug candidate cuts hospital, death risk in trial

China's Kintor Pharmaceutical said its potential COVID-19 treatment proxalutamide effectively reduced the risk of hospitalization and death in a clinical trial involving outpatients with mild to moderate symptoms. The results came from a multi-national clinical trial with over 700 subjects across the world, mostly from the United States, recruited during April-December, 2021, who were given either proxalutamide or a placebo, the company said in a filing. It remains unclear how many patients contracted the Omicron variant.
6th Apr 2022 - Reuters

Second booster shields elderly from COVID but protection wanes quickly - study

A fourth dose of the Pfizer/BioNTech vaccine lowered rates of COVID-19 among the elderly but the protection against infection appeared short-lived, a large study in Israel has found. The second booster's protection against infection dwindled after four weeks, Israeli researchers showed in their study published on Tuesday in the New England Journal of Medicine. Protection against severe illness did not wane during the six weeks after the dose but more follow-up study was needed to evaluate its longer-term protection, the researchers said.
6th Apr 2022 - Reuters

US Owes Pfizer $5 Billion for Covid Pills, Half of Proposed Aid Package

The Biden administration is on the hook to pay Pfizer Inc. nearly $5 billion for pills it’s already ordered to treat Covid-19, meaning as much as half of a scaled-back pandemic funding bill the Senate is debating is already spoken for, according to officials familiar with the matter. Senators announced a deal Monday to provide $10 billion in new Covid funding, far less than the White House has requested. The true purchasing power of the package will be even less because of commitments the government’s already made, the officials said. They asked not to be identified to discuss internal deliberations.
6th Apr 2022 - Bloomberg

China Drugmaker Kintor Up 229% After Reporting Covid Pill Effect

Chinese drug maker Kintor Pharmaceutical Ltd. soared in Hong Kong after saying its pill was highly effective in reducing the risk of hospitalization or deaths related to Covid-19, raising the prospect of a first homegrown antiviral treatment. Shares were up 141% as of 11:06 a.m. local time after earlier surging as much as 229%, the biggest jump since the company’s Hong Kong listing in mid-2020. The stock was also the best performer on the the Hang Seng Composite Index, which slid 1.6%.
6th Apr 2022 - Bloomberg

COVID vaccine in early pregnancy not tied to birth defects

Maternal COVID-19 vaccination in early pregnancy is not associated with fetal abnormalities detectable on ultrasound, finds a study yesterday in JAMA Pediatrics. The retrospective study, conducted by Northwestern University and Penn State College of Medicine researchers, used electronic medical records to identify any link between COVID-19 vaccination in early pregnancy and the risk of major fetal structural abnormalities on ultrasound. Major structural fetal abnormalities were defined as those identifiable on ultrasound in the second semester (18 to 24 weeks' gestation) that may affect the newborn's life expectancy, health, or functioning. Examples included malformation of the heart or spine. Functional defects were excluded from the study because they can't be assessed using ultrasound, the researchers said. "If the baby's heart isn't forming correctly, that could lead to the baby needing major cardiac surgery or long-term medication," senior author Emily Miller, MD, MPH, said in a Northwestern University news release.
5th Apr 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Apr 2022

View this newsletter in full

Covid Antibody Therapy From Vir, Glaxo Loses U.S. Authorization

A Covid-19 antibody treatment from Vir Biotechnology Inc. and GlaxoSmithKline Plc lost its U.S. authorization as the therapy is unlikely to work against the dominant omicron BA.2 subvariant, regulators said. The treatment, sotrovimab, is no longer authorized in any U.S. state or territory, since the subvariant accounts for more than half of virus cases in all regions, the U.S. Food and Drug Administration said Tuesday in a statement. Last month, the agency limited use of the drug only in parts of the country where the the subvariant dominated. Recent data suggested the treatment was less effective against BA.2 than other variants.
5th Apr 2022 - Bloomberg

Future of Covid Boosters Comes Down to Crucial Meeting of FDA Advisers

An all-star panel of Covid experts will convene this week to hash out how and when vaccines should be updated to address future variants as the virus continues to rapidly mutate. The meeting of U.S. Food and Drug Administration advisers should provide some of the first hints of its strategy to map out a more proactive plan for developing strain-specific boosters. Until now, the process has been led by drugmakers such as Moderna Inc. and Pfizer Inc., which have gained approval for boosters for specific populations. This is likely just the beginning. Many researchers believe the vaccines will need to be periodically updated to counteract new strains, just like annual flu shots
5th Apr 2022 - Bloomberg

Biden launches U.S. plan to help Americans struggling with long COVID

President Joe Biden on Tuesday tasked the U.S. health department with developing a national action plan to tackle the looming health crisis of long COVID, a complex, multi-symptom condition that leaves many of its sufferers unable to work. Long COVID, which arises months after a COVID-19 infection, affects nearly 7% of all U.S. adults and 2.3% of the overall population and has cost an estimated $386 billion in lost wages, savings and medical bills, according to an analysis by the Solve Long Covid Initiative, a non-profit research and advocacy group.
5th Apr 2022 - Reuters

Prior COVID vaccination induces a more robust antibody response to Omicron

A recent study posted to the medRxiv* preprint server assessed the impact of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination on the human immune response against SARS-CoV-2 Omicron infection. Various studies have reported lower susceptibility of the SARS-CoV-2 Omicron (B.1.1.529) variant against neutralizing antibodies. Therefore, it is necessary to understand the potential of previous SARS-CoV-2 infections in modifying the human immune response against the novel Omicron variant.
5th Apr 2022 - News-Medical.Net

Could computer models be the key to better COVID vaccines?

When Moderna joined the hunt for a coronavirus vaccine in early 2020, the company had only limited clinical experience with its technology. Scientists had tested the company’s messenger RNA (mRNA)-based vaccines against a few viruses, such as avian influenza and Zika, in humans. They found that the highest dose levels — upwards of 300 micrograms — often triggered undesirable side effects. The lowest doses (around 10 µg) did not always elicit a sufficient immune response. There seemed to be a happy medium: in a two-dose vaccine for another respiratory virus with pandemic potential1, a new strain of bird flu, the sweet spot was around 100 µg. So, it made intuitive sense for Moderna, based in Cambridge, Massachusetts, and its collaborators at the US National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, to try something similar to tackle SARS-CoV-2.
5th Apr 2022 - Nature

An equitable roadmap for ending the COVID-19 pandemic

Many governments are rolling back restrictions, but the pandemic will end only with a renewed focus on equitable distribution of vaccines and therapeutics, responsive public health plans, and policies to protect the vulnerable. More than 2 years into the COVID-19 pandemic, it remains unclear when and how it will end. The global outcome is dependent on multiple factors: the level of cooperation between governments; equitable access to vaccines, testing and therapeutics; local government action and the response of citizens; and competing outbreaks, conflicts or natural disasters. Ending the pandemic will also require a focus on the elderly and other vulnerable populations, as well as those in low- and middle-income countries (LMICs)
5th Apr 2022 - Nature

COVID-19: The endless search for the origins of the virus

Even as COVID-19 enters its third year as a pandemic, the world is no closer to knowing the source of the virus that sparked it all. Just six weeks after declaring a global health emergency, the World Health Organization (WHO) declared the spread of the new coronavirus a pandemic on March 11, 2020. But while the animal hosts of the coronaviruses that caused the 2003-2004 SARS and 2012 MERS outbreaks were identified in a matter of months, the origin of the current SARS-CoV-2 virus – along with its myriad mutations and variants – has proved more elusive. Last September, a task force set up by The Lancet COVID-19 Commission to search for the pandemic’s ultimate source was disbanded after 14 months, amid rancour, recriminations and concerns about conflicts of interest. And the probe by the WHO, a public health agency with no investigatory powers, has largely been stalled after a tightly controlled fact-finding trip to China in January 2021.
5th Apr 2022 - Al Jazeera English

We shouldn't dismiss 'incidental' covid-19 infections in UK hospitals

The UK is currently experiencing a surge in covid-19 cases caused by the omicron variant, in common with many countries. Inevitably, the number of people in UK hospitals with the illness is also rising, and reached 2509 people admitted on 28 March – just over half the daily admissions seen at the highest peak of the pandemic in the UK in January 2021, when it reached more than 4500 per day.
5th Apr 2022 - New Scientist

Omicron sub-variant BA.2 makes up 72% of COVID variants in U.S. - CDC

The U.S. national public health agency said on Monday the BA.2 sub-variant of Omicron was estimated to account for nearly three of every four coronavirus variants in the country. Overall COVID-19 cases in the United States have dropped sharply after hitting record levels in January, but a resurgence in cases in parts of Asia and Europe has raised concerns that another wave could follow in the United States. The country's health experts, however, believe it is unlikely. The seven-day moving average of U.S. COVID cases was 26,106 as of April 1, marginally lower than 26,309 from a week earlier, as per data from the U.S. Centers for Disease Control and Prevention (CDC).
5th Apr 2022 - Reuters

Covid-19 first-of-its-kind study saw volunteers infected for science

The first “controlled investigation” of Covid-19 has been carried out and it has allowed researchers to dispel a widespread myth about the way people become infected. The human challenge study involved people being deliberately infected with a virus — in this case it was SARS-CoV-2, the virus that causes Covid-19. The study, published last week in the journal Nature Medicine, found that only the most minuscule amount of the virus is needed to infect a person — as much as a single airborne droplet from a person sneezing, coughing or talking. It also found that, despite what most people have been told, viral shedding and transmissibility occur at high levels when a person is infected regardless of whether they have severe or mild symptoms.
5th Apr 2022 - News.com.au

China Variants and Omicron XE Put Fresh Focus on Covid Mutations

The disclosure of new Covid variants emerging in China and the rise of a potentially more transmissible strain in the U.K. has recast the spotlight on the ongoing risk of the virus, even as health experts say there’s no reason to panic. The World Health Organization said a hybrid of two omicron strains -- BA.1 and BA.2 -- that was first detected in the U.K. and dubbed XE could be the most transmissible variant yet. It is estimated to spread 10% more easily than BA.2, which itself was more transmissible than the original omicron famous for its ease of penetration.
4th Apr 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Apr 2022

View this newsletter in full

List of Official Covid Symptoms Expanded to Include Sore Throat and Fatigue

The official list of Covid-19 symptoms has been expanded to include nine new signs of illness. The extension of the symptoms list to include ailments such as sore throat, fatigue and headache could help to reduce infections, one expert said. News that the symptoms list has been updated emerged just days after the Government ended the offer of free universal Covid-19 tests. It comes as Covid infection levels have hit a record high in the UK, with almost five million people estimated to be currently infected.
4th Apr 2022 - Bloomberg

Study: Vaccine protects most cancer patients from COVID, but risk remains higher for patients with blood cancers

Using the nation’s largest COVID-19 data resource, a researcher at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center found the COVID-19 vaccine protected most cancer patients from getting COVID. However, patients with certain types of cancer have a higher and widely varied risk of breakthrough COVID infections after receiving the COVID vaccine. Jing Su, PhD, assistant professor in the Indiana University School of Medicine Department of Biostatistics was the lead investigator for the study published in the Journal of Clinical Oncology. He is also the core associate director of real-world data for the cancer center’s Biostatistics and Data Management Core. Su led a team of 13 investigators from 10 research institutes across the country to analyze data from the National COVID Cohort Collaborative (N3C) at the National Institutes of Health, including another researcher at IU School of Medicine, Xiaochun Li, PhD, a professor of biostatistics and health data sciences.
4th Apr 2022 - EurekAlert!

COVID-19 vaccine not associated with birth defects detectable on ultrasound

The exclusion of pregnant patients in initial COVID-19 vaccine clinical trials left many patients and doctors wondering how the vaccine might affect pregnant patients and their unborn babies. A new Northwestern Medicine study has found the vaccine is not associated with birth defects that are detectable on ultrasound. “This is yet another important piece of data that helps bridge the chasm that was left when pregnant individuals were excluded from those initial vaccine trials,” said corresponding author Dr. Emily Miller, chief of obstetrics at Northwestern Medicine and assistant professor of maternal fetal medicine at Northwestern University Feinberg School of Medicine. The study will be published April 4 in the journal JAMA Pediatrics.
4th Apr 2022 - EurekAlert!

China joins race to build a better Covid-19 vaccine with circRNA tech

China has joined the race to build a better Covid-19 vaccine using engineered circular RNA, a form of biotechnology that scientists hope can lead to cheaper and more effective shots. A group of scientists from Peking University, the Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing have been testing a circular RNA (circRNA) vaccine candidate targeting the tip of the coronavirus’s spike protein, which the virus uses to dock with the body’s receptors and cause infection. The team have released a preprint paper of the results of laboratory tests and animal trials and the study is being reviewed by scientific journal Cell. Companies and scientists are exploring the vaccine potential in transforming linear RNA into a circular shape.
4th Apr 2022 - South China Morning Post

Biological E to get mRNA technology from WHO to produce Covid vaccines

In a mkaoCity-based vaccine maker Biological E. Limited on Monday said the company was selected as a recipient of mRNA technology to produce COVID-19 vaccines from the World Health Organisation. A press release from BE Limited said the WHO's Advisory Committee on Vaccine Product Development (ACPDV) selected the firm after examining a number of proposals from India, as a recipient of mRNA (ribonucleic acid) technology from the global health body's technology transfer hub.
4th Apr 2022 - Business Standard

COVID-19 vaccine can cause temporary delay in menstruation

There have been increasing reports of changes to the menstrual cycle of younger individuals receiving coronavirus disease 2019 (COVID-19) vaccinations in the United Kingdom. Notably, the majority of people experiencing these changes after immunization find that their period returns to normal by the next cycle. Furthermore, there is no indication that COVID-19 vaccination has a deleterious effect on female fertility.
4th Apr 2022 - News-Medical.Net

Low number of Covid cases now as India chose right vaccine: Serum CEO

Serum Institute of India CEO Adar Poonawalla on Monday said the low number of COVID-19 cases at the moment was because the country chose the right vaccine. Speaking to reporters on the sidelines of the 'Alternate Fuel Conclave', he said the fourth wave, if at all it occurs, will hopefully be mild. Speaking on the booster dose, he said, "About the booster dose, we have appealed to the government, because everyone who needs to travel, needs the booster dose. They (government) are having internal discussions and a policy on booster dose may be announced soon."
4th Apr 2022 - Business Standard

Coronavirus vaccine: WHO suspends UN supply of Bharat Biotech's Covaxin vaccine for COVID-19

The World Health Organization said on Saturday it has suspended supply through United Nations agencies of COVID-19 vaccine Covaxin, produced by India's Bharat Biotech, to allow the manufacturer to upgrade facilities and address deficiencies found in an inspection. The WHO asked countries that have received the vaccine to take appropriate actions, according to the statement, but did not specify what the appropriate actions would be. The WHO said the vaccine is effective and no safety concerns exist, but the suspension of production for export will result in the interruption of Covaxin supply. It said the suspension is in response to the outcomes of WHO post emergency use listing (EUL) inspection conducted from March 14 to 22, and the vaccine maker has indicated its commitment to suspend production of Covaxin for export. Bharat Biotech did not immediately respond to a request for comment sent outside business hours.
4th Apr 2022 - Times of India

Covid had devastating toll on poor and low-income communities in US

The devastating impact of the Covid-19 pandemic on poor and low-income communities across America is laid bare in a new report released on Monday that concludes that while the virus did not discriminate between rich and poor, society and government did. As the US draws close to the terrible landmark of 1 million deaths from coronavirus, the glaringly disproportionate human toll that has been exacted is exposed by the Poor People’s Pandemic Report. Based on a data analysis of more than 3,000 counties across the US, it finds that people in poorer counties have died overall at almost twice the rate of those in richer counties. Looking at the most deadly surges of the virus, the disparity in death rates grows even more pronounced.
4th Apr 2022 - The Guardian

COVID-19 led to unprecedented decline in global life expectancy

The COVID-19 pandemic reduced the world’s life expectancy by about 2 years, according to recent estimates published in Population and Development Review. “Since 1950, annual declines of that magnitude had only been observed on rare occasions, such as Cambodia in the 1970s, Rwanda in the 1990s, and possibly some sub-Saharan African nations at the peak of the AIDS pandemic,” wrote Patrick Heuveline, a professor of sociology and the associate director of the California Center for Population Research at UCLA.
4th Apr 2022 - Healio

UK Covid symptoms list expanded with nine more signs of illness

The official list of Covid-19 symptoms on the NHS has been extended to cover nine new symptoms, including sore throat, fatigue and headache. They join the three symptoms of a fever, a new and persistent cough, and a loss or change in taste or smell, according to nhs.uk. Extending the list may help reduce infections by helping people detect whether they may have Covid; however, it coincides with the end of the offer of free universal Covid-19 tests to help people confirm whether they have the virus. Covid infection levels have hit a record high in the UK, with almost 5 million people estimated to be infected.
4th Apr 2022 - The Guardian

U.S. poor died at much higher rate from COVID than rich - report

Americans living in poorer counties died during the pandemic at almost twice the rate of those in rich counties, a study released Monday by the Poor People's Campaign showed. The study, based on income and death data from over 3,200 U.S. counties, shows an even bigger gap during the Delta variant that made up the U.S.'s fourth coronavirus wave, when people living in the lowest income counties died at five times the rate of those in the highest income counties. The 300 counties with the highest death rates have an average poverty rate of 45%, and household median incomes on average $23,000 lower than counties with lower rates.
4th Apr 2022 - Reuters

Roche says U.S. FDA grants priority review to Actemra for COVID-19

Roche said on Monday the U.S. Food and Drug administration granted priority review to its Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults. "If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalised patients," Roche said in a statement, adding that more than 1 million people hospitalised with COVID-19 had been treated with Actemra/RoActemra worldwide since the beginning of the pandemic.
4th Apr 2022 - Reuters

New Covid-19 variant Omicron XE found in the UK which is a cross mutation of the BA.1 and BA.2 strains

Health experts have confirmed that a new variant of Coronavirus has been found in the United Kingdom. The UK Health Security Agency (UKHSA) have said that they are looking at the XE variant - which is a cross mutation of the BA.1 and BA.2 Omicron strains that recently swarmed the nation. The new variant is what is technically known as a 'recombinant' according to professionals, however the UKHSA are reported saying that it's too early to know whether it is more transmissible than the previous versions of the virus - reports Wales Online. The officials say that 637 cases of XE have been detected in England alone as of March 22, which would make it a mere fraction of the tens of thousands of total cases being reported daily at the time of writing, The Independent has reported.
4th Apr 2022 - Chronicle Live

CanSinoBIO's mRNA COVID vaccine candidate cleared for trials in China

Chinese vaccine developer CanSino Biologics Inc (CanSinoBIO) said on Monday its potential COVID-19 vaccine using the messenger RNA (mRNA) technology has been approved by China's medical products regulator to enter clinical trials. Unlike other major countries, China is yet to approve any foreign-made mRNA vaccines such as that produced by U.S.-German duo Pfizer Inc (PFE.N) and BioNTech SE . With around 88% of its 1.4 billion population already vaccinated, China is trailing several domestically developed mRNA vaccine candidates, including one candidate that is being tested in a large, Phase 3 clinical trial.
4th Apr 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Apr 2022

View this newsletter in full

Two Chinese mRNA Covid Vaccines Move Toward Clinical Trials

A Chinese company said it’s received approval to start clinical trials of a Covid-19 vaccine based on mRNA technology, while local media reported that another domestic company has applied to start a similar trial. CSPC Pharmaceutical Group Ltd. has been approved by China’s medical product regulator to begin a trial of an COVID-19 vaccine named “SYS6006,” it said in a statement to the Hong Kong stock exchange. The company said pre-clinical studies demonstrated the vaccine can help neutralize against the omicron variant of coronavirus. It does not need to be stored at below-freezing temperatures, the company said. China has inoculated the majority of its population using domestically-made coronavirus vaccines based on older inactivated virus technology, but authorities have not approved any based on mRNA outside the cities of Hong Kong and Macau.
3rd Apr 2022 - Bloomberg

‘Eventually everyone may need Covid booster doses’

How prepared was NIV to handle the pandemic when it started two years ago? No one can be prepared for a pandemic of this nature, but I must give it to my team that rose to the occasion, working literally 24x7 for months on end to manage the crisis. Our preparedness can be gauged by the fact that India was the fifth country in the world to isolate Sars-Cov-2 virus, and first country to isolate the Alpha variant.
2nd Apr 2022 - Hindustan Times

Covid experts call for return of free tests as UK cases hit new high

Covid has hit an all-time high across the UK, with almost 5 million people – one in 13 of the population – estimated to have the virus, according to the most recent official data, prompting experts to call for the return of free testing. The figures from the Office for National Statistics (ONS) came on the day the government ended free rapid tests for most people in England and as tens of thousands of people were hoping to embark on Easter holidays. Many will have to pay for a test to find out if they are infected, whether they are symptomatic or not. While UK hospitalisations and deaths are also rising, these are not in line with the spike in infections, and scientists said they expect levels to fall sharply again in April and May.
2nd Apr 2022 - The Guardian

Vaccination after COVID improves immunity; ivermectin fails in major trial

Vaccination after COVID-19 improves immunity. Although people who recover from COVID-19 usually gain some immune defenses against reinfection, they get additional protection from vaccines, especially against severe disease, according to two studies published on Thursday in The Lancet Infectious Diseases.
1st Apr 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Apr 2022

View this newsletter in full

FDA grants Pfizer/BioNTech expanded EUA for an additional COVID-19 vaccine booster

Pfizer/BioNTech have been given an expanded emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for its COVID-19 vaccine. This allows the vaccine to be given to adults ages 50 years and older as a second booster. Eligible adults can have had any authorised COVID-19 vaccine as their first booster. A second booster dose has also authorised for those aged 12 years and older who are immunocompromised, and have had a first booster dose of any authorised COVID-19 vaccine. The second booster should be given at least four months after the initial booster and could potentially restore antibody levels and improve protection in older people. It is the same formulation and strength as previous Pfizer/BioNTech COVID-19 vaccine doses. The companies’ vaccine already has EUA authorisation for use as a single booster for those aged 12 and older who have already had two doses of the vaccine. Those aged 18 and older could have received any approved COVID-19 vaccines for their initial two doses.
31st Mar 2022 - PMLiVE

CureVac and GSK try again with COVID-19 vaccine -

CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up. The first participants have been dosed in a new, second generation version – dubbed CV2CoV – which uses a different mRNA backbone and will be a key test of CureVac’s new vaccine design approach. When the first generation vaccine CVnCoV failed its phase 2b/3 test last summer, the writing looked to be on the wall for the alliance, with multiple COVID-19 shots already available with more coming down the pipeline – including GSK and Sanofi’s recombinant protein candidate – and prospects looking slim in an increasingly crowded market. CureVac and GSK are banking on continued, long-term demand for SARS-CoV-2 shots as boosters as COVID-19 shifts from a pandemic to an endemic disease, with regular shots to control infections like flu.
31st Mar 2022 - PharmaPhorum

‘This massive undertaking was invisible’: film glimpses behind the curtain as Covid vaccine was made

How to Survive a Pandemic, investigative journalist and director David France’s documentary on the road to developing, producing and inequitably distributing several Covid-19 vaccines, begins on the day vaccines went from murky future to clear horizon. The film opens in December 2020, in the remarkably bespoke basement of the US Food and Drug Administration’s Dr Peter Marks. The room is decked in Mardi Gras beads and a teddy bear; Marks’s clunky work laptop is surrounded by cans of oats. On camera and on the phone with Gen Gustave Perna, the chief operating officer of the federal Covid-19 response for vaccine and therapeutics, Marks celebrates the FDA’s emergency use authorization of the Pfizer-BioNTech vaccine. “Sorry you had to deal with all that political crap,” says Perna. “Vaccines will be moving tomorrow.”
31st Mar 2022 - The Guardian

Rokote Laboratories selects Exothera for GMP manufacturing of its second-generation coronavirus vaccine FINCoVac 2.0.

Rokote Laboratories Finland Ltd., a vaccine development company focussing on a second-generation COVID-19 vaccine, and Exothera S.A. will collaborate to bring the intranasal coronavirus vaccine FINCoVac 2.0 to clinical Phase I/II trials. Exothera will finetune the industrialization of the FINCOVAC 2.0 process and manufacture clinical material for Phase I/II trials. FINCoVac 2.0 is designed to address the most critical current coronavirus variants and it is based on adenoviral vector gene transfer technology. The FINCoVac vaccine is designed to program the nasopharyngeal cells to produce an immune response-inducing modified SARS-CoV-2-viral spike protein. FINCoVac 2.0 represents an easy-to-administer booster for those who are already fully vaccinated with other coronavirus vaccines.
31st Mar 2022 - BioSpace

Novavax asks EU to approve coronavirus vaccine for adolescents

Novavax has submitted a request Thursday to expand the authorization of its coronavirus vaccine to adolescents in the EU. The vaccine, which was approved for use in adults in the EU in December, was the first protein-based COVID-19 jab to be authorized in the bloc. In a statement Thursday, Novavax said it had submitted a request to the European Medicines Agency to expand the conditional marketing authorization of their vaccine, called Nuvaxovid, to young people aged between 12 and 17. “We are continuing to see spikes in COVID-19 across Europe and recognize the need to improve vaccination rates, particularly in the pediatric population,” said Stanley C. Erck, Novavax’s CEO. “We look forward to a decision from the European Medicines Agency and firmly believe in the benefit of diversified vaccine options.” The request includes data from an ongoing trial of the jab in teenagers in the U.S., which the drugmaker said demonstrated 80 percent efficacy at a time when the Delta variant was the dominant strain in the U.S.
31st Mar 2022 - POLITICO Europe

Ivermectin ineffective at preventing COVID-19 in new, large study

A study published on Wednesday found the use of ivermectin to combat COVID-19 did not lead to reduced hospitalization. In Brazil, 3,515 people participated in a study where a group received ivermectin, a group received a placebo and another group received a different form of treatment for COVID-19. The study, posted in The New England Journal of Medicine, says the results concluded ivermectin does not lower the risk of COVID-19 hospitalization. “Treatment with ivermectin did not result in a lower incidence of medical admission to a hospital due to progression of Covid-19 or of prolonged emergency department observation among outpatients with an early diagnosis of Covid-19,” the study states.
31st Mar 2022 - The Hill

NIH begins clinical trial evaluating second COVID-19 booster shots in adults

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The trial aims to understand if different vaccine regimens—prototype and variant vaccines alone and in combinations—can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
31st Mar 2022 - EurekAlert!

FDA places full clinical hold on CytoDyn's Covid-19 programme

The US Food and Drug Administration (FDA) has placed a complete clinical hold on CytoDyn’s Covid-19 programme in the country. With the full clinical hold in place, the company will not launch any new clinical trials until the regulatory agency lifts the hold. At present, CytoDyn is not carrying out any Covid-19 trials in the US, as the company is analysing the most ideal programmes to invest its resources and focus. A clinical stage biotechnology company, CytoDyn is analysing its leronlimab, an investigational humanised IgG4 monoclonal antibody, for its potential in various treatment areas, including infectious disease, cancer and autoimmune conditions.
31st Mar 2022 - Pharmaceutical Technology

Covid-19: Lockdowns spread in China as omicron tests “zero covid” strategy

The force of the omicron BA.2 variant this week met the immovable object that is China’s zero covid policy as Shanghai locked down amid the country’s worst outbreak since early 2020. World oil prices fell and Indian drug manufacturers warned of ingredient shortages as the city responsible for 4% of China’s gross domestic product posted record case numbers on 30 March. About 9 million residents of Pudong, the eastern half of Shanghai, have been locked down since 28 March. Bridges across the Huangpu River are closed. On the other bank, roughly 15 million people in the west of the city, centred around Puxi, were to begin a lockdown on 1 April as Pudong reopened. But many western districts were locked down two days early as city authorities released figures showing a continued steep rise in cases. In Puxi, a robot patrolled the streets, announcing the new schedule. In Pudong, residents were warned that drones with facial recognition technology would identify those illegally outdoors. A new lockdown was also imposed on 30 March in Xuzhou, a city of three million in Jiangsu province.
31st Mar 2022 - The BMJ

Covid-19 news: Omicron's reinfection risk 10 times higher than delta's

In the UK, the risk of being reinfected with SARS-CoV-2 virus is 10 times higher with omicron than delta. The Office for National Statistics’ (ONS) Covid-19 Infection Survey estimates the number of reinfections that occurred in the UK between July 2020 and 20 March 2022. From 20 December 2021 to 20 March 2022, when omicron was the dominant variant, the risk of reinfection was about 10 times greater than when delta dominated, defined as mid-May 2021 to 19 December. Reinfection definitions vary. The ONS defines it as a positive PCR test result after a number of negative results, following an initial infection. The specific number of negative results required between infections depends on when the reinfection occurred, as definitions have changed over time. Covid-19 immunity, whether naturally acquired or via vaccines, wanes over time, leaving people more vulnerable to reinfection. Omicron has also evolved to better evade immunity.
31st Mar 2022 - New Scientist

EMA starts review of Sanofi-GSK COVID vaccine application

The European Union's drug regulator has started reviewing Sanofi and its British partner GlaxoSmithKline's application seeking conditional authorization for their COVID-19 vaccine, the agency said on Wednesday. The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be used as a booster as well as a standalone two-dose shot. In support of the companies' application, the final data package comprising a late-stage trial of the vaccine and another trial testing it as a booster was submitted to the European Medicines Agency (EMA) on March 29, the drugmakers said in an email to Reuters.
31st Mar 2022 - Reuters

Pfizer/BioNTech COVID vaccine slashes pediatric hospitalization risk -U.S. study

Children ages 5 to 11 who received the Pfizer, BioNTech COVID-19 vaccine were 68% less likely to be hospitalized during the Omicron wave in the United States than unvaccinated children, according to a study published on Wednesday. Adolescents aged 12-18 who received two shots of the vaccine were around 40% less likely to be hospitalized with the Omicron variant of the virus, the study led by scientists from the U.S. Centers for Disease Control and Prevention (CDC) and Boston Children's Hospital found. It was published in the New England Journal of Medicine. The risk of more serious outcomes, including need for mechanical breathing assistance or death, was nearly 80% lower for those who received the shots in that age group.
31st Mar 2022 - Reuters

WHO says most likely scenario shows COVID severity will decrease over time

The World Health Organization on Wednesday released an updated plan for COVID-19, laying out three possible scenarios for how the pandemic will evolve this year. "Based on what we know now, the most likely scenario is that the COVID-19 virus continues to evolve, but the severity of disease it causes reduces over time as immunity increases due to vaccination and infection," Director-General Tedros Adhanom Ghebreyesus said during a briefing. However, the WHO head cautioned that periodic spikes in cases and deaths may occur as immunity wanes, which may require periodic boosting for vulnerable populations.
31st Mar 2022 - Reuters

Analysis: Governments want COVID vaccine developers to aim higher in hunt for better shots

As governments prepare to live with COVID-19, some are questioning how much to rely on drugmakers to adapt vaccines to ward off future virus variants amid signs of tension between companies and regulators over the best approach, according to several sources familiar with the matter. Some vaccine experts say government agencies should fund and help develop a new generation of COVID shots, and seek innovation from smaller developers, as they did to identify current vaccines. "We have established a research infrastructure that could do this relatively reasonably rapidly if we primed the pump and created the same kind of plan for second-generation vaccines as we did for the first-generation vaccines," Dr. Larry Corey, a virologist who is overseeing U.S. government-backed COVID vaccine trials, told Reuters.
31st Mar 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 31st Mar 2022

View this newsletter in full

How Does Covid Affect Diabetes, the Brain and Long Covid?

Commenting on Britain’s near-record-high number of Covid cases, the U.K.’s chief medical officer, Chris Whitty, said last Wednesday that we should expect seasonal peaks for the next few years, interspersed with new variants of SARS-CoV-2. As we move into the post-pandemic, living-with-the-virus era, more research is surfacing about the ways even mild Covid cases leave lingering effects on health in some people. Three conditions in particular are capturing scientists’ attention due to the large number of sufferers: increased rates of diabetes, neuropsychological problems, and the illness known as long Covid. Researchers have found associations between Covid infections and each of these issues, but we don’t know enough yet to establish causality. Bloomberg Opinion columnist Therese Raphael and Bloomberg Intelligence senior pharmaceutical analyst Sam Fazeli look at why the long tail of Covid is hard to pin down.
30th Mar 2022 - Bloomberg

CureVac and GSK Start Clinical Development of Second-Generation COVID-19 Vaccine Candidate, CV2CoV

CureVac N.V. a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the first participant was dosed in a Phase 1 study of COVID-19 second-generation mRNA vaccine candidate, CV2CoV, developed in collaboration with GSK. The clinical trial is expected to provide valuable data to further evaluate the performance of CureVac's second-generation mRNA backbone, which has the potential to be applied broadly in future vaccines against COVID-19 variants and other pathogens. A preclinical study of CV2CoV in cynomolgus macaques, published in Nature in November 2021, demonstrated rapid induction of higher antibody titers, better induction of immune memory and stronger protective efficacy of CV2CoV compared to CureVac's first-generation vaccine candidate, CVnCoV. The same study demonstrated comparable neutralizing antibody titers in animals fully vaccinated with either 12µg of CV2CoV or a 30µg standard dose of a licensed mRNA COVID-19 vaccine..
30th Mar 2022 - PharmiWeb

Those with allergies should not fear Covid-19 vaccines, Hong Kong medical experts say, citing poll showing few suffer adverse reactions

Hongkongers suffering from allergies should not be afraid of getting a Covid-19 vaccine, medical experts said on Wednesday, citing a poll revealing only a small number of such patients reported adverse reactions after receiving jabs. Only eight out of 161 respondents with allergies said they had experienced a negative reaction and needed to consult a doctor after receiving at least one dose of a vaccine, according to a survey conducted by the Hong Kong Allergy Association in March. The group said the eight people had recovered after treatment. “The figure is not alarming. The reason why the respondents consulted doctors may not be due to their allergies,” said Dr Philip Li Hei, a specialist in immunology and allergy, adding that even those who experienced a reaction could still get the second and third dose.
30th Mar 2022 - South China Morning Post

Moderna's COVID-19 Vaccine Boosts Some Antibodies More than Pfizer's

In many ways, the two mRNA COVID-19 vaccines—BNT162b2 made by Pfizer and mRNA-1273 by Moderna—are very similar. But real-world vaccine efficacy has begun to show subtle differences across the two approved mRNA platforms. A new study has investigated the variation in immune responses induced by the BNT162b2 and mRNA-1273 vaccines. To do this, the researchers profiled the post-boost binding and functional capacity of humoral immune responses induced by the two vaccines in a cohort of hospital staff. The study found that both vaccines induced robust humoral immune responses to SARS-CoV-2 and to variants of concern.
30th Mar 2022 - Genetic Engineering & Biotechnology News

COVID vaccines: head-to-head comparison reveals how they stack up

A rare head-to-head comparison shows that the COVID-19 vaccines made by Pfizer and Moderna outperform those from Johnson & Johnson and Novavax1. The data also provide a finely detailed picture of the immune protection that each vaccine offers — information that could be useful for designing future vaccines. The research was posted on the preprint server bioRxiv on 21 March. It has not yet been peer reviewed. The study assessed the 4 vaccines using 14 metrics, including levels of several types of immune cell such as T cells and B cells, as well as immune molecules called neutralizing antibodies. Such investigations are sorely needed to sort through the flood of COVID-19 vaccines in the research pipeline and on the market, researchers say.
30th Mar 2022 - Nature

Preclinical investigation of intranasal adjuvanted COVID-19 vaccine

The researchers observed antibodies against the S1 and NC antigens in all the animals except those controlled negatively. However, the serological responses varied significantly. Serum IgG titers were significantly elevated in mice receiving vaccines with N3 adjuvant and exhibited nearly a 10-fold increase, and increasing the concentration of anionic L3 to 2% resulted in comparable antibody titers. A similar trend was observed only after the second vaccination for IgA titers, nearly 10-fold higher than the first dose. Microneutralizing antibody titers differed variably across mice receiving different vaccine doses. Mice in groups 5 (1 µg dose + N3 adjuvant) and 6 (0.1 µg + N3 adjuvant) exhibited significantly higher antibody titers. At the same time, those with L3 adjuvants had higher antibody titers than the positive control group. All immunized mice produced IgA antibodies against the SARS-CoV-2 antigens in the respiratory and gastrointestinal tracts.
30th Mar 2022 - News-Medical.Net

Decline of testing, sequencing could hinder search for future COVID-19 variants, experts warn

Throughout the COVID-19 pandemic, disease surveillance efforts that rely on testing and variant sequencing have been critical tools in the global efforts to fight the virus. Without these tools, experts said, the spread of COVID-19 could have been exponentially greater, potentially resulting in many more deaths. "Testing and sequencing have been critical to understanding where the virus is and how it is evolving. This is critical information for response and mitigation efforts," Dr. Rebecca Katz, professor and director of the Center for Global Health Science and Security at Georgetown University, told ABC News. Surveillance tools have helped health officials make important recommendations throughout the pandemic -- including the decision to green light booster doses for extra protection, and decision to pull back on some monoclonal antibody treatments authorized for COVID-19, following concerns that it was not effective against certain variants.
30th Mar 2022 - ABC News

COVID-19 vaccines for the youngest children may be inching closer to authorization – a pediatrician explains how they're being tested

For some parents of young children, the wait for COVID-19 vaccines has been long and agonizing. Throughout 2021, vaccines against COVID-19 emerged as the most effective way to prevent severe forms of the disease. Vaccines are currently recommended for everyone 5 years and older in the United States but are not yet available for younger age groups. Though more rare in young children, severe disease leading to hospitalization and even death from COVID-19 can occur. Recent U.S. rates of COVID-19-associated hospitalization in those under 5 have been the highest on record, as a result of the surge in cases from the highly transmissible omicron variant.
30th Mar 2022 - The Conversation

BioNTech's quarterly profit soars on COVID-19 vaccine demand

BioNTech, the German pharmaceutical company that teamed with Pfizer to develop the first widely used COVID-19 vaccine, on Wednesday reported strong quarterly earnings growth on pandemic-fueled demand. The company posted net profit of nearly 3.2 billion euros ($3.6 billion) for the final three months of 2021, up from 367 million euros in the same period the previous year. Earnings per share rose to 12.18 euros from 1.43 euros a year ago. Quarterly revenue rose to 5.5 billion euros from 345.4 million euros previously
30th Mar 2022 - ABC News

Ghana to start producing own Covid-19 vaccines in January 2024

Ghana will start producing its own COVID-19 vaccines in January 2024, President Nana Akufo-Addo said on Wednesday in his State of the Nation Address in parliament. A National Vaccine Institute would be established to lay out a strategy for the West African country to begin the first phase of commercial production for the jabs, he said without providing further details. "A bill will shortly be brought to you, in this House, for your support and approval for the establishment of the National Vaccine Institute," he said. So far Ghana has fully vaccinated around 21.4% of its 30-million-odd inhabitants against coronavirus, according to Reuters data.
30th Mar 2022 - Reuters

BA.2 Omicron subvariant is now dominant among US Covid-19 infections

The BA.2 subvariant of Omicron is now the dominant Covid-19 variant in the US, estimated to represent more than half of coronavirus variants circulating in the country, according to federal health officials. The US Centers for Disease Control and Prevention estimates that the so-called “stealth” Omicron variant was discovered in nearly 55 per cent of samples that underwent genetic sequencing within the last week, the agency announced on 28 March. Scientists have attributed BA.2’s rapid growth to its several key mutations; the gene for the spike protein on its surface has eight mutations not found in BA.1. Researchers have determined that such mutations have made BA.2 more transmissible, not that it necessarily evades antibody protection or causes more-severe illness.
30th Mar 2022 - The Independent

Covid-19: Americans who are over 50 or immunocompromised are advised to have second booster

Second booster doses against covid-19 for Americans aged over 50 and for certain immunocompromised people aged over 12, using either the Pfizer-BioNTech or the Moderna vaccine, may become available as early as later this week after they were authorised in the US. The new recommendations from the Food and Drug Administration (FDA)1 and the Centers for Disease Control and Prevention (CDC)2 come as the BA.2 omicron variant spreads rapidly in the US and is responsible for about 55% of new infections. The variant seems to be more contagious but does not cause more severe infections. Peter Marks, director of the CDC’s Center for Biologics Evaluation and Research, said on 29 March, “Current evidence suggests some waning of protection over time against serious outcomes from covid-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna covid-19 vaccine could help increase protection levels for these high risk individuals
30th Mar 2022 - The BMJ

BioNTech to expand trial programme for more anti-Omicron vaccine options

BioNTech has expanded an ongoing clinical trial programme to develop new vaccines and patterns of administration for better protection against the dominant Omicron coronavirus variant as it reported a profit boost from its first-generation shot. The enlargement of its trial programme with partner Pfizer, initially unveiled in January, comes as global COVID-19 cases are on the rise and protection against infection from its established Comirnaty vaccine has waned, though protection against severe disease remains. BioNtech boosted the number of participants in the trial - in which participants' blood will be monitored for immune responses - to 2,150 from the 1,420 announced in January.
30th Mar 2022 - Reuters

Pfizer, Moderna win over FDA for second round of COVID-19 boosters in older adults

Only two weeks after Pfizer and its partner BioNTech asked the agency for an emergency use authorization (EUA) for a second round of COVID-19 boosters in people 65 and older, the FDA has granted the nod. The new FDA authorization covers those who have already been boosted with any COVID vaccine and are either 50 and older or 12 and older if they are immunocompromised. At around the same time on Tuesday morning, Moderna said the FDA had granted its application for a second booster. The Moderna nod covers adults over 50 who have been boosted once, plus immunocompromised adults over 18. Moderna applied for a second booster on March 17.
30th Mar 2022 - FiercePharma

Patients with both COVID-19 and influenza four times more likely to need ventilation support, study suggests

Patients infected with both COVID-19 and influenza at the same time are more than four times more likely to require ventilation support and more than twice as likely to die, compared with just having COVID-19, research published in the Lancet has suggested. The study was delivered as part of the International Severe Acute Respiratory and emerging Infection Consortium’s Coronavirus Clinical Characterisation Consortium; the largest study to look at COVID-19 and other endemic respiratory viruses. The researchers examined the clinical outcomes of 212,466 patients co-infected with COVID-19 and either influenza, respiratory syncytial virus (RSV) or an adenovirus, who were admitted to hospital in the UK between 6 February 2020 and 8 December 2021.
29th Mar 2022 - The Pharmaceutical Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Mar 2022

View this newsletter in full

Omicron BA.2 Variant Is Dominant Covid-19 Strain in U.S., CDC Estimates

The Omicron BA.2 variant represents more than half of new Covid-19 cases in the U.S., the latest federal estimates show, as signs suggest infections are edging higher again in parts of the Northeast. The region has the highest BA.2 concentrations, including more than 70% in an area including New York and New Jersey, according to estimates the Centers for Disease Control and Prevention released Tuesday. BA.2 has been moving steadily higher for more than a month and represents an estimated 55% of national cases in the week ended March 26, the CDC said. Public-health authorities and experts are watching BA.2 closely, in part because it appears to spread more easily than the version that caused record levels of Covid-19 cases and hospitalizations in the U.S. this winter. BA.2 has fueled new surges in European countries including the U.K., where pandemic trends have often presaged events in the U.S. Parts of Asia, including Hong Kong and Shanghai, are also confronting serious Omicron surges.
30th Mar 2022 - The Wall Street Journal

Sputnik V: How the Russian war has affected Russian vaccines

If Sputnik V once looked like a vital tool for the Kremlin’s geopolitical ambition, it now looks like another victim of it. Following the Russian invasion of Ukraine on Feb. 24, both RDIF and Dmitriev are now under Western sanctions. The U.S. Treasury said the sovereign wealth fund is widely considered “a slush fund” for Russian President Vladimir Putin and “emblematic of Russia’s broader kleptocracy,” while the chief executive was dubbed a “close associate” of the Kremlin leader. In a letter received after the initial publication of this article, the RDIF described the Treasury’s accusation as “defamatory.”
29th Mar 2022 - The Washington Post

West Lothian’s Valneva factory ‘could provide UK with Covid vaccines for years to come’

A state-of-the-art vaccine manufacturing facility in West Lothian could play a key role if the UK needs annual vaccines against coronavirus. The chief executive of Valneva, which is commissioning the site in Livingston, said he still hopes to supply the immunisation despite a UK Government contract for one hundred million doses being terminated last year. Thomas Lingelbach says it is one of only a handful worldwide able to make what are called ‘inactivated whole virus vaccines’. The CEO is now keeping a close eye on developments at the plant and told STV News this could be vital as covid evolves into the post pandemic era.
29th Mar 2022 - STV News

Fourth COVID-19 vaccine dose substantially reduces mortality in the elderly

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant was largely responsible for a resurgence of coronavirus disease 2019 (COVID-19) cases in late 2021. In Israel, a campaign to implement a fourth vaccine or second booster was introduced by the Ministry of Health for those at high risk of infection from this variant who had already received three doses of vaccine. To this end, Israel approved a second booster dose on January 2, 2022, for people aged 60 and older, high-risk groups, and healthcare personnel who had received a first booster dose at least four months prior.
29th Mar 2022 - News-Medical.Net

EU regulator starts reviewing Spanish COVID vaccine booster

The European Union’s drug regulator said Tuesday it has begun an accelerated review process for an experimental coronavirus vaccine booster made by the Spanish company Hipra. The European Medicines Agency said in a statement that its evaluation is based on preliminary data from laboratory studies and research in adults that compared Hipra’s booster shot to the vaccine made by Pfizer-BioNTech. It said early results suggest the immune response achieved with Hipra “may be effective” against COVID-19, including the hugely infectious omicron variant.
29th Mar 2022 - The Associated Press

EULAR takes 'precautionary position' in support of third, booster COVID-19 vaccine doses

Citing a lack of available data and time, EULAR has taken a “precautionary position” in support of third and booster COVID-19 vaccine doses for patients with rheumatic and musculoskeletal diseases. “There are concerns that individuals on certain immunosuppressive or immunomodulatory drugs may not mount an adequate protective response to COVID-19 vaccination,” Robert B.M. Landewé, MD, PhD, of Amsterdam UMC, and colleagues wrote in the Annals of the Rheumatic Diseases. “Data are not currently available to reliably identify who might, or might not, benefit from a third primary dose of a SARS-CoV-2 vaccine. Taking a precautionary position, third primary doses are being recommended by some authorities in selected groups of individuals and EULAR supports this approach.”
29th Mar 2022 - Healio

EC approves AstraZeneca's Evusheld for Covid-19 prevention

The European Commission (EC) has granted marketing authorisation to AstraZeneca’s Evusheld (AZD7442) for Covid-19 pre-exposure prophylaxis, or prevention, in adults and adolescents age 12 years and above. Evusheld is a cocktail of two long-acting antibodies (LAAB), tixagevimab (AZD8895), and cilgavimab (AZD1061). The LAABs are obtained from B-cells of convalescent patients following Covid-19 and attach to particular sites on the spike protein of the SARS-CoV-2 virus. The treatment dose approved for use in the region is 150mg intramuscular doses of tixagevimab and cilgavimab, each, given sequentially.
29th Mar 2022 - Pharmaceutical Technology

Specialist nurse appointed for rare Covid-19 condition affecting children

A hospital in London has become one of the first in the UK to appoint a dedicated nurse for a rare inflammatory condition in children linked to Covid-19. Evelina London Children's Hospital has recruited Michael Bell into the role of clinical nurse specialist for paediatric cases
29th Mar 2022 - Nursing Times

Covid-19: Oxygen shortages two years into pandemic highlight pre-covid failures, says WHO

Two years into the covid-19 pandemic, access to oxygen is still a major problem in low and middle income countries, health leaders have warned. The shortages have highlighted the “abject failure” of the global community to develop and build up primary healthcare and universal health coverage over the past 20 years, said Michael Ryan, the World Health Organization’s health emergencies programme executive director. “Covid didn’t cause this, covid uncovered this. Covid laid bare, tore away the bandages from, some very, very old wounds,” Ryan told an Access to Covid-19 Tools (ACT) Accelerator briefing. “No one was interested in oxygen,” he said, despite it being vital for the treatment of patients with covid-19 in the early stages of the pandemic. “I went to meeting after meeting and I spoke about oxygen, and nobody was listening because oxygen wasn’t sexy. It wasn’t new. It wasn’t some technological advance that could be delivered to the world. Oxygen was boring, oxygen was old,” Ryan said.
29th Mar 2022 - The BMJ

Premature deaths in elderly due to Covid in England and Wales among worst in the world

Elderly people in England and Wales had the highest rate of premature deaths to Covid-19 among 20 comparable countries, researchers have shown. The study by University of Manchester epidemiologists, published in the Journal of Global Health, reveals 5.78 per cent of the over-90s were lost to the disease. In Sweden the figure was 3.82 per cent, Italy 3.18 per cent, Germany 2.46 per cent and France 2.08 per cent. In the Netherlands, the figure for the over 95s was 3.87 per cent. The high mortality rate was largely due to the failure to stop the virus from sweeping through care homes as older patients were discharged from hospital without being tested. There was a substantial increase in deaths in care homes in England and Wales in the first three months of the pandemic – estimated by other researchers at 79 per cent.
29th Mar 2022 - iNews

HIV drugs may lower COVID risk; COVID and flu co-infection raises risk of severe illness, death

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. HIV drugs may curb COVID-19 risk. Certain drugs used to treat HIV may have a role in preventing SARS-CoV-2 infections, according to preliminary data that may help explain why people living with the condition have not appeared to be at higher risk for serious COVID-19 despite being generally more vulnerable to infections.
29th Mar 2022 - Reuters

EU starts real-time review of Hipra's COVID vaccine

Europe's drug regulator said on Tuesday it had started a real-time review of Spanish pharmaceutical firm Hipra's COVID-19 vaccine candidate. The decision by the human medicines committee of the European Medicines Agency (EMA) to begin the rolling review is based on early results from clinical studies, which compared the immune response to the vaccine with that seen with Pfizer/BioNTech's Comirnaty, the regulator said. The agency did not say when the review is expected to be completed.
29th Mar 2022 - Reuters

Explainer: Omicron 'stealth' COVID variant BA.2 now dominant globally

A sub-variant of the highly transmissible Omicron version of coronavirus known as BA.2 is now dominant worldwide, prompting surges in many countries in Europe and Asia and raising concern over the potential for a new wave in the United States. Below is a summary of what is known about BA.2...
29th Mar 2022 - Reuters

Explainer: Why are Shanghai's COVID infections nearly all asymptomatic?

Article reports that epidemiologists examining the biggest Chinese outbreak of COVID-19 in two years are trying to ascertain why the proportion of asymptomatic cases is so high, and what it could mean for China's future containment strategy. The number of new confirmed community transmitted cases in the major financial hub of Shanghai reached 4,477 on Tuesday, a record high, but only 2.1% showed symptoms. The share of symptomatic cases over the previous seven days was around 1.6%. Although outbreaks overseas have demonstrated that Omicron was less deadly than its predecessors, with lower levels of hospitalisation, the rate of symptomatic infection was relatively high compared to China's numbers.
29th Mar 2022 - Reuters

FDA OKs another Pfizer, Moderna COVID booster for 50 and up

U.S. regulators on Tuesday authorized another COVID-19 booster for people age 50 and older, a step to offer extra protection for the most vulnerable in case the coronavirus rebounds. The Food and Drug Administration’s decision opens a fourth dose of the Pfizer or Moderna vaccines to those people at least four months after their previous booster. Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this especially fragile group also can get an additional booster, a fifth shot.
29th Mar 2022 - The Associated Press

Covid-19 pandemic isn’t over for Black Americans, report warns

A searing report released Tuesday by the Black Coalition Against COVID details the immense toll the Covid-19 pandemic has taken — and continues to take — on Black communities, and calls for continued vigilance and action to prevent further losses even as the rest of the nation is eager to move on. The report’s authors — physicians and public health and policy experts — note with alarm that even as case rates began to fall sharply across the country earlier this year, the Covid-19 hospitalization rate for Black people was higher than it had been at any time during the pandemic for any racial or ethnic group. For the week ending Jan. 8, 2022, the hospitalization rate for Black Americans was 64 per 100,000 — more than twice the overall rate. Rates for all Americans have since fallen, though they remain much higher for Black people.
29th Mar 2022 - STAT News

‘A slow-moving glacier’: NIH’s sluggish and often opaque efforts to study long Covid draw patient, expert ire

The National Institutes of Health is fumbling its first efforts to study long Covid. Fifteen months ago, Congress showered the agency with a massive $1.2 billion to research the mysterious cases of patients who never fully recover from Covid-19 infections. But so far the NIH has brought in just 3% of the patients it plans to recruit. Critics charge that the NIH’s missteps are even bigger: that it is acting without urgency, that it is taking on vague, open-ended research questions rather than testing out therapies or treatments, and that it is not being fully transparent with patient advocates and researchers.
29th Mar 2022 - Scientific American

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Mar 2022

View this newsletter in full

Botswana Approves Corbevax Covid Vaccine, Plans Local Output

Corbevax, a Covid-19 vaccine developed in Texas, has been approved for use in Botswana, according to U.S. biotech billionaire Patrick Soon-Shiong. Doses of the vaccine currently in production have been reserved for the country, he said at a ceremony on Monday in the southern African nation’s capital, Gaborone. It will ultimately be made at a local factory called Pula Corbevax, Botswanan President Mokgweetsi Masisi said. Soon-Shiong is helping launch production and the facility may later make another inoculation produced by his ImmunityBio Inc. “It has now been given to 10 million young Indians safely,” Soon-Shiong said. “We have now brought it to Botswana.”
28th Mar 2022 - Bloomberg

Fourth vaccine reduces COVID-19 deaths by 78% - study

The fourth coronavirus vaccine resulted in a 78% decrease in COVID-19 related deaths in adults aged 60-100, according to a new study by Clalit Health Services. The study, conducted by Clalit, Sapir College and Ben-Gurion University of the Negev, examined the effect the second booster shot had on mortality rates of the population eligible to receive it in Israel. The research was led by Dr. Ronen Arbel, a health outcomes researcher at Clalit Health Services and Sapir College. The paper is currently awaiting peer review.
28th Mar 2022 - The Jerusalem Post

AstraZeneca’s COVID-19 preventative drug secures EU approval

AstraZeneca's Evusheld has been approved in the EU for the prevention of COVID-19 in adults and teens 12 years and older weighing at least 40 kg.
28th Mar 2022 - BioPharma-Reporter

COVID-19 booster essential, even among individuals previously infected

A long-term, cohort study led by researchers at the Azrieli Faculty of Medicine of Bar-Ilan University and Ziv Medical Center in Safed has produced further insight regarding the interplay between COVID-19 infection and vaccination in providing protection over time. Seven to nine months after the second dose of the vaccine, antibody levels throughout the cohort dropped and were comparable in all groups including among young people and those infected before vaccination. The booster, however, led to antibody levels ten times higher than after the second dose in all groups within the cohort. The study, recently published in the journal Clinical Infectious Diseases, further showed that all individuals, including those with hybrid immunity (infected and vaccinated) require subsequent boosters beyond the two initial COVID-19 vaccine doses.
28th Mar 2022 - Arutz Sheva

Studies link Covid-19 infection with increased risk of new diabetes diagnosis

Over a year after recovering from a Covid-19 infection, Jennifer Hobbs is adjusting to her new normal: brain fog, joint pain, elevated liver enzymes and, now, type 2 diabetes. Hobbs had prediabetes before she got Covid-19, but her blood sugar levels were under control, and she didn't need any treatment. Recently, that changed. "I take my blood sugar [level] every morning, and even with two different types of medication, it's all over the place," said Hobbs, 36. The new diabetes diagnosis has both Hobbs and her primary care provider wondering if the coronavirus has played a role. Two years into the pandemic, scientists and physicians are shifting their attention to the long-term consequences of a Covid-19 infection, termed "long Covid." Recent studies add diabetes to the list of possible long Covid outcomes.
28th Mar 2022 - CNN

Medicago's tobacco ties jeopardize growth of its COVID shot

Canadian vaccine maker Medicago's COVID-19 vaccine, approved last month in Canada, is facing limited growth in the near-term after the World Health Organization said it would not review the vaccine because the company is partly owned by U.S.-Swiss tobacco company Philip Morris, health experts say. The WHO said at a briefing this month and in a follow-up statement to Reuters that it has not accepted an application for the vaccine because of its 2005 public health treaty requiring no involvement with any company that produces or promotes tobacco-based products.
28th Mar 2022 - Reuters

Second COVID vaccine booster significantly lowers death rate, Israeli study shows

Senior citizens who received a second booster of the Pfizer–BioNTech COVID-19 vaccination had a 78% lower mortality rate from the disease than those who got one only, a study from Israel showed on Sunday. The country's largest healthcare provider, Clalit Health Services, said the 40-day study included more than half a million people aged 60 to 100. Some 58% of participants had received a second booster - or two shots in addition to the basic two-shot regimen. The remainder had received only one booster.
28th Mar 2022 - Reuters

UK study to test Pfizer's COVID pill in hospitalised patients

Pfizer's oral COVID-19 therapy will be evaluated as a potential treatment for patients hospitalised with the illness in a major British trial, scientists said on Monday, as cases rise in some parts of the world. The world's largest randomised study of potential medicines for COVID-19, dubbed the RECOVERY trial, will assess Paxlovid across hospitals in Britain, which has already approved the drug for early-stage treatment. "Paxlovid is a promising oral antiviral drug but we don't know if it can improve survival of patients with severe COVID-19," said Peter Horby, a professor at the University of Oxford and joint chief investigator of the RECOVERY trial.
28th Mar 2022 - Reuters

Scientists: COVID-19 may cause greater damage to the heart

The pain in his chest was sudden, heavy. Juan Sosa was at home doing pushups in the bedroom where he had isolated himself for almost two weeks after testing positive for COVID-19. His mild symptoms were long gone, and it was the final day of his quarantine. A retired carpenter, Sosa had been vaccinated and considered himself a pretty healthy 58-year-old. He thought he had gas and wasn’t too worried. But the pain was severe so he drove himself to a walk-in clinic. Doctors quickly determined Sosa was having a heart attack. An ambulance rushed him to HCA Florida Brandon Hospital. The last thing he remembers that day is a nurse cutting open his T-shirt. Veteran cardiologist Hoshedar Tamboli was seeing patients at his Brandon office when he got the call about a patient in cardiac arrest.
28th Mar 2022 - The Associated Press

COVID-19 vaccines not tied to adverse pregnancy outcomes

Two studies published yesterday in JAMA, one from Sweden and Norway and one from Ontario, find no link between COVID-19 vaccination during pregnancy and adverse outcomes. No link to preterm birth, stillbirth, NICU admission In the first study, a team led by researchers from the Norwegian Institute of Public Health in Oslo and the Karolinska Institute in Stockholm studied 157,521 singleton pregnancies ending after 22 weeks' gestation among vaccinated and unvaccinated pregnant women listed in national birth registries. The study period began Jan 1, 2021, ending on Jan 12, 2022, in Sweden, and 3 days later in Norway. Of the 157,521 births, 103,409 took place in Sweden, and 54,112 occurred in Norway. Average maternal age was 31 years, and 18% were vaccinated against COVID-19 during pregnancy (12.9% with Pfizer/BioNTech, 4.8% with Moderna, and 0.3% with AstraZeneca/Oxford). Among the vaccinated women, 4.4% received only one vaccine dose, while 13.7% had two
28th Mar 2022 - CIDRAP

FDA halts use of GlaxoSmithKline and Vir's COVID-19 drug Xevudy in 8 northeast states

With new strains of the coronavirus showing their elusiveness and pushing more antibody treatments toward irrelevance, is there danger of an over-reliance on COVID-19 oral antivirals, especially Pfizer’s Paxlovid? Friday, the U.S. paused the distribution of GlaxoSmithKline and Vir Biotechnology’s antibody drug Xevudy in the northeast, where the omicron subvariant BA.2 now accounts for more than half of new infections. The states included in the directive are Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island and Vermont. In addition, Xevudy’s use will be halted in Puerto Rico and the Virgin Islands. Lab testing shows that a 500-mg dose of Xevudy is not “fully active” against the BA.2 variant, the FDA said.
28th Mar 2022 - FiercePharma

Patients with Covid and flu double the risk of dying, say scientists

Covid-19 patients who have been hospitalised should also be routinely tested for flu, researchers have said. The call was made after the publication of a paper in the medical journal the Lancet that revealed having both conditions more than doubles the risk of a patient dying. Scientists also discovered that individuals who had contracted both Sars-CoV-2, the virus that causes Covid-19, and influenza viruses were more than four times more likely to require ventilation support and 2.4 times more likely to die than if they just had Covid-19. “We found that the combination of Covid-19 and flu viruses is particularly dangerous,” said Professor Kenneth Baillie of Edinburgh University. “We expect that Covid-19 will circulate with flu, increasing the chance of co-infections. That is why we should change our testing strategy for Covid-19 patients in hospital and test for flu much more widely.”
27th Mar 2022 - The Guardian

Moderna weighs private market debut for COVID shot as federal funding flounders

As Congress gridlocks on funding for new COVID-19 therapies and vaccines, mRNA bigwig Moderna is setting its sights on the endemic market for its wildly successful shot, Spikevax, the biotech’s CEO has said. “[W]hat is not clear today is, will the U.S. become a private market, which is the case for all other medicines we have access to,” Stéphane Bancel speculated in an interview with Yahoo Finance during Moderna’s 3rd annual Vaccines Day on Thursday. The U.S. government says funding for COVID vaccines and therapeutics is waning, which could spell trouble for Moderna’s megablockbuster shot sales. In fact, Moderna's $21 billion in advanced purchase agreements for this year includes no contribution from the U.S., Bancel pointed out. Still, the feds could step in yet to purchase shots for the public, the CEO suggested.
25th Mar 2022 - FiercePharma

Officials limit an antibody therapy, saying it’s ineffective against BA.2 variant of Omicron

U.S. health officials on Friday stopped the further deployment of the Covid-19 treatment sotrovimab to places where the BA.2 coronavirus variant is now causing the majority of infections, given laboratory studies showing the treatment likely doesn’t work against the variant. States in New England, as well as New York, New Jersey, Puerto Rico, and the Virgin Islands, will no longer receive shipments of the monoclonal antibody therapy made by Vir Biotechnology and GSK, officials said. This is not the first time that the evolution of the SARS-CoV-2 virus has undercut the power of certain antibody therapies, which have generally been designed to target the virus’ spike protein. When the Omicron family of viruses took off late last year, the government halted shipments of antibody therapies made by Lilly and Regeneron when it became clear that they would no longer work against the strains that were circulating.
25th Mar 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Mar 2022

View this newsletter in full

The BA.2 Omicron subvariant is now dominant in northeastern US states

The Omicron BA.2 subvariant has become dominant over other Covid-19 coronavirus variants in the northeastern US, per the latest CDC data. The news comes as a surge of new cases in Europe, driven by the more-contagious BA.2 and by countries lifting Covid-19 restrictions. That surge is prompting some experts to worry that another wave could soon be coming to the US. Experts told previously Insider they expect a wave of BA.2 in the US could be milder than in Europe, in part because of previous exposure to its cousin, the subvariant BA.1. More vulnerable groups could still be at risk, the experts said. As of last week, BA.2 made up 55.4% of samples collected in Health & Human Services (HHS) Region 1, the CDC said Tuesday. This region covers Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont, as well as ten federally recognised Tribal Nations.
27th Mar 2022 - Business Insider South Africa

Edinburgh scientists find patients with both Covid and flu at greater risk of severe illness and death

Adults in hospital with Covid-19 and the flu at the same time are at much greater risk of severe disease and death compared with patients who have Covid-19 alone or with other viruses, according to new research. Scientists found that patients who had both SARS-CoV-2, which causes Covid-19, and influenza viruses were more than four times more likely to require ventilation support and 2.4 times more likely to die than if they just had Covid-19. The study looked at more than 305,000 hospitalised patients with Covid-19 and involved researchers from the University of Edinburgh, University of Liverpool, Imperial College London and Leiden University in the Netherlands. Researchers say the findings show the need for more flu testing of Covid-19 patients in hospital and highlight the importance of full vaccination against both Covid-19 and the flu. Professor Kenneth Baillie, professor of experimental medicine at the University of Edinburgh, said: “We found that the combination of Covid-19 and flu viruses is particularly dangerous.
27th Mar 2022 - STV News

U.S. to Clear Additional Booster Shot Against Covid-19

The U.S. Food and Drug Administration is poised to clear a fourth dose of the mRNA coronavirus vaccine for adults age 50 and older, looking to shore up protections for more vulnerable groups, a person familiar with the matter said. The authorization could come as early as next week and, for most Americans, it would mean a second booster shot of either the Pfizer-BioNTech or Moderna vaccines. Currently, only immunocompromised people are eligible in the U.S. for the additional dose. Unlike with previous authorizations, the FDA is expected to stop short of a full recommendation, meaning the option would be open for people who want the shot. The development was reported earlier by the New York Times.
27th Mar 2022 - Bloomberg

Covid cases predicted to hit new peak within fortnight

Covid cases will peak in the next two weeks, government modelling has suggested. Health chiefs are braced for infections to reach record levels next week but are confident they will “top out” shortly after without threatening to overwhelm hospitals, The Times has been told. It explains why government scientific advisers are not more concerned about a recent surge in the virus — more over-50s are now infected than at any time during the pandemic. Figures next week are expected to show record infections across the board after the latest data from the Office for National Statistics (ONS) showed that cases had risen in all age groups and regions this month.
26th Mar 2022 - The Times

How to get a Cuban COVID jab in 1,000 easy steps

On Valentine’s Day 2022 in Havana, Cuba, I received the Soberana Plus booster shot, one of the island nation’s five homegrown COVID-19 vaccines. The jab had been a long time coming. For the past year, I had been fixated on the idea of being injected with a made-in-Cuba coronavirus vaccine. While obviously not offering protection against the imperial machinations of my homeland and Cuba’s chief antagonist, the United States, the Cuban serums were at least being developed in the interest of global public health rather than pharmaceutical profit or “vaccine apartheid”, as World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus has described it.
26th Mar 2022 - Al Jazeera English

South Australia records seven deaths from COVID-19, a day after close contact rules are eased

Seven people have died in South Australia after testing positive to COVID-19 – one day after close contact rules were relaxed across the state. SA Health said five women and two men aged between 70 and over 100 died from the disease. The state now has 151 people in hospital with the virus, including five in the Intensive Care Unit and one on a ventilator – slightly less than on Friday. There were 3,897 new cases reported, down from 4,459 on the previous day.
26th Mar 2022 - ABC News

Covid-19 patients infected with flu twice as likely to die, study shows

People who are simultaneously infected with Covid-19 and influenza face double the risk of death, according to a new study, highlighting the challenge being posed to health systems as flu re-emerges. The research, led by scientists and medics at academic institutions across Europe as part of the disease response network Isaric, found that unvaccinated patients infected with the two viruses were 2.3 times more likely to die and 4.1 times more likely to require a ventilator, compared with people only infected with coronavirus. Geert Groeneveld, one of the study authors and an infectious disease physician at the Leiden University Medical Center in the Netherlands, said the harm from a co-infection of Covid and flu probably stemmed from how they both “destroy the respiratory tract” in severely ill patients.
25th Mar 2022 - Financial Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Mar 2022

View this newsletter in full

Sinovac Booster Gives Elderly Stronger Protection Against Omicron, Study Finds

Two doses of China’s Sinovac vaccine offered older people only a moderately high level of protection against severe disease and death from Covid-19, but a third dose significantly bolstered their defenses, according to a new study by scientists in Hong Kong. The study, based on patients infected during the current devastating Omicron wave in Hong Kong, serves as a cautionary note for mainland China, where Sinovac is a pillar of the country’s vaccination program. Many older people there have yet to receive booster shots. For people 60 and older, two Sinovac doses were 72 percent effective against severe or fatal Covid-19 and 77 percent effective against Covid-related death, the study found.
24th Mar 2022 - The New York Times

Moderna to Seek Authorization of Its Coronavirus Vaccine for Young Children

Moderna said on Wednesday that it would seek emergency authorization of its coronavirus vaccine for children younger than 6, after interim results from its clinical trial showed that volunteers in that age group had a similar immune response to young adults when given a dose one-fourth as strong. But the company said the vaccine proved only about 44 percent effective in preventing symptomatic illness among children 6 months to 2 years old, and 37 percent effective in children 2 through 5. Dr. Jacqueline Miller, the firm’s senior vice president for infectious diseases, said the relatively low level of protection demonstrated the ability of the Omicron variant to evade the vaccine’s shield. Nonetheless, she said in an interview, “what we have seen is a successful trial.”
24th Mar 2022 - The New York Times

Virtusa Delivers COVID-19 Vaccine Tracker

Virtusa Corporation today announced that its Virtusa Vax Manager is available to provide businesses with an easy way to track employee vaccination status. The COVID-19 vaccine tracker and return to office capabilities of Virtusa Vax Manager can be built rapidly, and is easily configurable on technology from Pegasystems, the software company that crushes business complexity, to help companies stay compliant with emerging regulations, while ensuring the wellbeing of all employees and easing the burden on HR staff.
24th Mar 2022 - The Korea Bizwire

No fall in Covid-19 antibody levels among elderly, figures suggest

Covid-19 antibody levels among UK adults remain at a record high, with no evidence of a drop among older age groups whose most recent dose of vaccine was likely to be several months ago, analysis suggests. Some 99.3% of people aged 80 and over in England were likely to have antibodies at the start of March, along with 98.2% in Wales and 98.3% in Scotland – the highest for each nation since estimates began at the end of 2020. The figures, which have been calculated by the Office for National Statistics (ONS), also estimate 99.2% of over-70s in Northern Ireland had antibodies at the beginning of this month – again, the highest level so far.
24th Mar 2022 - Evening Standard

AstraZeneca's preventative COVID shot set to win EU clearance this week-sources

Europe's drug regulator is expected to give the go-ahead this week for AstraZeneca's antibody-based injection for preventing COVID-19 infections, two people familiar with the review said, following U.S. and UK approvals. The treatment is meant for adults whose immune system is too weak to respond to vaccines and offers a new tool to ease the pandemic burden on healthcare systems. Infections in Europe are on a sharp rise again this month, with the adult vaccination rate stagnating at a little over 83%. The expected recommendation by the European Medicines Agency (EMA) is set to be confirmed swiftly by the European Commission, which has the final word on market access.
24th Mar 2022 - Reuters

COVID pandemic fuelled 2021 population drop in 73% of U.S. counties

The toll of the COVID-19 pandemic was reflected in a natural decrease last year in the population of nearly three-quarters of U.S. counties versus the two previous years, the census bureau said on Thursday. More than 73% of U.S. counties experienced natural decrease, or an excess of deaths over births, up from 55.5% in 2020 and 45.5% in 2019, bureau data showed. "In 2021, fewer births, an aging population and increased mortality – intensified by the COVID-19 pandemic - contributed to a rise in natural decrease," the U.S. Census Bureau said in a statement.
24th Mar 2022 - Reuters

Moderna raises full-year COVID vaccine sales forecast to $21 billion

Moderna Inc raised its full-year forecast for sales of its COVID-19 vaccine to roughly $21 billion from $19 billion. The company in February forecast sales of $19 billion from its signed contracts, and option for $3 billion in additional purchases. Moderna on Thursday forecast additional purchases of roughly $500 million.
24th Mar 2022 - Reuters

Simple home oxygen monitors signal when to seek COVID care

COVID-19 patients can safely use inexpensive pulse oximeters at home to watch for a drop in blood oxygen that signals they need to seek advanced care, according to a systematic review published yesterday in The Lancet Digital Health. Pulse oximeters are small devices that shine light through a patient's finger to measure his or her blood oxygen saturation. They can be used alone or as part of a remote patient monitoring (RPM) package. Imperial College London researchers analyzed 13 observational studies involving 2,908 participants in five countries using pulse oximetry to monitor their blood oxygen levels from when the COVID-19 pandemic began in 2020 to Apr 15, 2021. Some RPM programs had participants monitor their own oxygen levels, while others developed a mobile app or website for patients to report their readings. Participants included older people with more than one underlying illness, young people, and pregnant and postpartum women. All participants had COVID-19 except for 12 controls in one study.
23rd Mar 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Mar 2022

View this newsletter in full

Moderna says its coronavirus vaccine for young children is safe, but efficacy is a more complicated picture

Vaccine maker Moderna announced Wednesday its two-dose pediatric coronavirus vaccine was safe in young children, toddlers and babies in a study. But the effectiveness of the shot in children 6 months to 5 years old was more of a mixed picture because of the challenge presented by the highly transmissible omicron variant. In a trial of the vaccine, the shot met the main criteria the company and regulators had defined for success, generating immune defenses equivalent to or better than those that protected young adults before the omicron variant emerged, according to a Moderna news release. But in the face of omicron, the immune defenses mustered by two doses in adults were less robust, particularly in preventing infections — and the same pattern was seen in children, with vaccine efficacy of about 40 percent.
23rd Mar 2022 - The Washington Post

Study examines the effectiveness of remdesivir in a pill form for COVID-19

Scientists at the University of North Carolina at Chapel Hill are testing remdesivir in a pill form to understand how effective it is for treating COVID-19. Remdesivir is an RNA polymerase inhibitor that disrupts the production of viral RNA, preventing the multiplication of SARS-CoV-2; it has been given to half of all hospitalised patients with the disease. It works by blocking the machinery the virus needs to make copies of itself and spread throughout the body. The scientists explored whether a pill form of remdesivir could be developed and the benefits that it could provide. Currently, remdesivir is administered intravenously, however, an oral version of this medication could extend its benefits to outside the hospital.
23rd Mar 2022 - Health Europa

Covid-19 pandemic could lead to rise in global TB cases, expert warns

The Covid-19 pandemic could lead to a rise in tuberculosis infections around the world as some patients will have gone undiagnosed amid the crisis, an expert has warned. Dr Laura Cleghorn, of the University of Dundee, said there is a “pressing need” to develop new treatments for illness which some wrongly think of as a “disease of yesteryear”. The University’s Drug Discovery Unit (DDU) has received a $5 million (£3.8 million) grant from the Bill & Melinda Gates Foundation to speed up the delivery of drug candidates. The primary focus of the work, which will take place over three years, will be on tuberculosis (TB), however, researchers will also work on developing treatments for malaria and future viral pandemic diseases.
23rd Mar 2022 - The Independent

S.Korea gives emergency approval for adult use of Merck's COVID pills - Yonhap

South Korea's drug safety agency said on Wednesday that it has decided to give emergency approval for the use of Merck & Co Inc's COVID-19 treatment pill for adults, the Yonhap news agency reported. The molnupiravir tablet, branded as Lagevrio, is the second oral antiviral to be authorised in South Korea after Pfizer Inc's Paxlovid. Lagevrio will only be allowed for patients who are aged 18 or older and not pregnant but cannot not use injection medications and the highly effective Paxlovid, the report said.
23rd Mar 2022 - Reuters

Novavax says its COVID vaccine gets India authorisation for teens

Novavax Inc said on Tuesday its COVID-19 vaccine has got emergency-use authorization from the Drugs Controller General of India for children aged 12 to 17 years. The authorization is a global first for the age group for the vaccine, which is manufactured and marketed in India by the Serum Institute of India under the brand name Covovax. Novavax last month said its vaccine was 80% effective against COVID-19 in a late-stage trial testing the shot in 2,247 teens aged 12 to 17 years.
23rd Mar 2022 - Reuters

COVID vaccine maker Moderna flags Japan ambition with sumo sponsorship

Moderna Inc is sponsoring sumo flags in its first such promotion in Japan, as the COVID-19 vaccine maker seeks to wrestle market share from compatriot Pfizer Inc. The U.S. firm's introduction to the broader Japanese public was set back after some of its doses last year were found to be contaminated, although it has clawed back market share since with the help of a government-endorsed programme. Now, as the government plans a fourth-dose vaccination programme, Moderna is looking to sumo to boost its public appeal as it seeks to expand beyond COVID-19 shots.
23rd Mar 2022 - Reuters.com

Lawsuit says India's Emcure stole COVID-19 vaccine secrets for IPO

Seattle biopharma company HDT Bio Corp has sued Indian generic drugmaker Emcure Pharmaceuticals Ltd in U.S. court for allegedly stealing RNA-delivery technology to use in its COVID-19 vaccine. HDT's lawsuit, filed Monday in Seattle federal court, also said Emcure was planning to go public in India based on the stolen technology, and misappropriated trade secrets that HDT licensed to an Emcure subsidiary. The lawsuit adds to a growing number of recent intellectual-property disputes involving Pfizer, Moderna, and others over the use of mRNA technology in COVID-19 vaccines.
23rd Mar 2022 - Reuters

Antibodies in children last at least 6 months after COVID; SK Bioscience vaccine shows promise vs Omicron

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Antibodies in kids after COVID last 6 months or more Most children and adolescents with COVID-19 antibodies after SARS-CoV-2 infection usually still have the antibodies in their blood more than half a year later, new data shows. Starting in October 2020, researchers in Texas recruited 218 subjects between the ages of 5 and 19. Each provided three blood samples, at three-month intervals. More than 90% were unvaccinated when they enrolled in the study.
23rd Mar 2022 - Reuters

Moderna to seek regulatory approval for COVID shot for very young children

Moderna Inc said on Wednesday it will ask regulators to authorize its COVID-19 vaccine in children younger than 6 years old based on data showing it generated a similar immune response to adults in its clinical trial. The Omicron variant of COVID-19 was predominant during Moderna's pediatric trial, and the drugmaker said two doses were around 38% effective in preventing infections in 2 to 5 year olds and 44% effective for children 6 months to under 2 years old. It said these figures were consistent with the lower effectiveness against Omicron seen in adults who had received two doses of its vaccine.
23rd Mar 2022 - Reuters

Risk of type 2 diabetes rises after COVID; organ transplant from donors who had COVID likely safe

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Type 2 diabetes risk rises after COVID-19 People may be at increased risk for developing diabetes for up to a year after a diagnosis of COVID-19, according to two studies. One study used data from the U.S. Department of Veterans Affairs to track more than 181,000 adults with COVID-19 for a year after recovery
23rd Mar 2022 - Reuters

COVID-19 in pregnancy tied to poor maternal outcomes, preterm birth, fetal death

In the first study, published in JAMA Internal Medicine, Kaiser Permanente Northern California researchers analyzed the electronic medical records of 43,886 pregnant women who delivered from Mar 1, 2020, to Mar 16, 2021. Average patient age was 30.7 years, 33.8% were White, 28.4% were Hispanic, 25.9% were Asian or Pacific Islander, 6.5% Black, 0.3% American Indian or Alaska Native, and 5% were multiracial or of another race. Among these women, 1,332 (3.0%) tested positive for COVID-19 from 30 days before conception to 7 days after delivery. Infected women were more likely than their uninfected peers to be younger and Hispanic and to have had multiple babies, a higher neighborhood deprivation index, and obesity or chronic high blood pressure. Before universal COVID-19 testing of pregnant women admitted for delivery was implemented in the healthcare system in December 2020, the positivity rate was 1.3%, compared with 7.8% after.
22nd Mar 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Mar 2022

View this newsletter in full

New research proves benefit of vaccination after recovery from COVID-19

When our immune system comes into contact with the SARS-CoV-2 coronavirus, it fights back and produces antibodies. A similar immune response is triggered by Corona vaccines. However, there is still little data available on the strength and durability of immune protection. A team led by Prof. Carsten Watzl from the Leibniz Research Centre for Working Environment and Human Factors Institute for Occupational Research (IfADo), in cooperation with the Max Planck Institute of Molecular Physiology (MPI) and the Klinikum Dortmund, has now been able to detect high levels of neutralizing antibodies in test persons even 300 days after a coronavirus infection with the original variant of the coronavirus.
22nd Mar 2022 - News-Medical.Net

How protected are we against Covid-19? Scientists search for a test to measure immunity

In 2010, doctors told Ben Sobieck, now 37, that his kidneys were inexplicably failing. Shortly after, he had a kidney transplant and started on the lifelong medications that weaken his immune system to keep his body from rejecting the donor organ. They never figured out what caused Sobieck's kidney failure. But a decade later, he confronted another threat to his health: the Covid-19 pandemic. "I am on immunosuppressants that make me more vulnerable for serious Covid complications," said Sobieck, 37, who lives in Minnesota. "If you're immunocompromised, you may not have a very good response to the [Covid-19] vaccine." Seeking evidence that his immune system was working the way it should, Sobieck made an unusual request: He asked his nephrologist to do a blood test that gives a rough measure of antibodies, a type of protein the body creates in response to an infection or vaccine. Antibody titers reveal the concentration of a specific antibody found in someone's blood.
22nd Mar 2022 - CNN

Covid-19 news: Infection linked to higher risk of developing diabetes

Covid-19 linked to a 46 per cent increased risk of type 2 diabetes. People who have had covid-19 within the past year may be more at risk of developing type 2 diabetes for the first time or being prescribed medication to manage their blood sugar levels. Ziyad Al-Aly at the VA Saint Louis Health Care System in the US and his colleagues reviewed the medical records of 181,280 individuals who tested positive for covid-19 between March 2020 and September 2021, using data from the US Department of Veterans Affairs. The team compared the number of new diabetes cases among these veterans with that of more than 8 million people who had no evidence of a covid-19 infection. None of the participants had diabetes at the start of the study. Covid-19 was linked to a 46 per cent higher risk of developing type 2 diabetes or requiring blood-sugar-lowering medication, even among people with a mild or asymptomatic covid-19 infection. Type 2 diabetes occurs when the body cannot make enough insulin or the hormone that is produced does not work properly. SARS-CoV-2 virus may inflame insulin-producing cells, decreasing their efficiency, Al-Aly told The Washington Post.
22nd Mar 2022 - New Scientist

AstraZeneca COVID drug neutralises Omicron sub-variants in lab study

Data from the latest study by Washington University in the United States showed the therapy reduced the amount of virus detected in samples - viral load - of all tested Omicron sub-variants in mice lungs, AstraZeneca said. The study has yet to be peer reviewed. Evusheld was tested against the BA.1, BA.1.1, and BA.2 sub-variants of Omicron and it was also shown in the study to limit inflammation in the lungs - a critical symptom in severe COVID-19 infections. "The findings further support Evusheld as a potential important option to help protect vulnerable patients such as the immunocompromised who could face poor outcomes if they were to become infected with COVID-19," John Perez, head of Late Development, Vaccines & Immune Therapies at AstraZeneca, said.
22nd Mar 2022 - Reuters

Former Takeda vaccine chief to lead new COVID antiviral venture Aerium

Aerium Therapeutics, a venture-backed startup, on Tuesday announced industry veteran Rajeev Venkayya will lead the company and released data that showed its two experimental monoclonal antibodies neutralized coronavirus variants, including Omicron and its fast-spreading subvariant BA.2, in lab studies.
22nd Mar 2022 - Reuters

Most unvaccinated children lack antibodies after COVID; SK Bioscience vaccine shows promise vs Omicron

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Antibodies in kids after COVID last 6 months or more Most children and adolescents with COVID-19 antibodies after SARS-CoV-2 infection usually still have the antibodies in their blood more than half a year later, new data shows. Starting in October 2020, researchers in Texas recruited 218 subjects between the ages of 5 and 19
22nd Mar 2022 - Reuters

Coronavirus may double severe complications in pregnancy

Article reports that the study was published in JAMA Internal Medicine on March 21. An analysis of records for 43,886 pregnant individuals during the first year of the COVID-19 pandemic found that the 1,332 who had a coronavirus infection during pregnancy had more than double the risk of negative outcomes compared with individuals without the virus. “These findings add to the growing evidence that having COVID-19 during pregnancy raises risks of serious complications,” explained lead author Assiamira Ferrara, MD, PhD, a senior research scientist and associate director of the women’s and children health section in the Kaiser Permanente Division of Research. “Coupled with the evidence that the COVID-19 vaccines are safe during pregnancy, these findings should aid patients in understanding the risks of perinatal complications and the need for vaccination,” said Dr. Ferrara. “This study supports the recommendation for vaccination of pregnant individuals and those planning conception.”
22nd Mar 2022 - EurekAlert

Experts warn there may be more than one type of Deltacron Covid hybrid

In many countries, as restrictions lift and freedoms are restored, there’s a general feeling that the pandemic is over. There is, however, still the significant concern that a dangerous new variant could emerge. This happened when omicron arrived, but we got lucky with that one. Omicron turned out to be more transmissible, but mercifully it hasn’t caused an increase in severe disease in most countries where it is dominant. But this wasn’t guaranteed. Variants crop up randomly, and new ones have the potential to be more dangerous than previous ones. Another has just arrived, and is currently going by the name deltacron. It is – as you can probably guess – a hybrid of delta and omicron, the two variants dominant most recently. Deltacron’s story begins in mid-February, when scientists at the Institut Pasteur in Paris uploaded a genetic sequence of the coronavirus that looked very different from previous sequences. The virus sample had come from an elderly man in northern France and looked odd. Most of its genetic sequence was the same as delta’s, which was dominant worldwide up until late last year, but the part of the sequence that encodes the virus’s spike protein – a key part of its external structure, which it uses to get inside cells in the body – came from omicron.
22nd Mar 2022 - Wales Online

Clues to Covid-19’s Next Moves Come From Sewers

At a sewage treatment plant on a sliver of land in Boston Harbor, trickles of wastewater are pumped into a plastic jug every 15 minutes. Samples from the jugs, analyzed at a lab in nearby Cambridge, Mass., are part of the growing effort to monitor the Covid-19 virus in wastewater across the U.S. On Deer Island in Boston, readings from the system covering 2.4 million people have recently shown virus readings leveling off after a steep decline from this winter’s Omicron-driven rise. In some areas, levels of the virus may be edging higher.
22nd Mar 2022 - The Wall Street Journal

Hong Kong study says reopening international travel to have little impact on COVID transmission

The full reopening of international travel in Hong Kong will have "little marginal impact" on the spread of COVID-19, an academic study said on Tuesday, as the financial hub begins to unwind strict coronavirus measures. The study, titled "Forward planning, after HK's fifth wave of Omicron BA.2", expects a sixth wave to begin in June as measures to control the spread of the disease are relaxed in the months ahead and the city increases vaccination rates. As long as arrivals are fully vaccinated and test negative upon boarding a flight to the Chinese-ruled territory, they would have a negligible impact, according to experts from the University of Hong Kong, the World Health Organization and the Laboratory of Data Discovery for Health.
22nd Mar 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Mar 2022

View this newsletter in full

New Research Shows Higher Risk of Developing Diabetes After Covid-19 Infection

A large new study found that people who recovered from Covid-19 within the past year are 40% more likely to receive a new diagnosis of diabetes compared to those who weren’t infected. The increased risk translates into 1% of people who have had Covid-19 developing diabetes who otherwise wouldn’t have, the study’s author says, resulting in potentially millions of new cases world-wide. Most of the people with diabetes in the study, published online Monday in the journal Lancet Diabetes and Endocrinology, were diagnosed with Type 2 diabetes, not Type 1. Some researchers say Covid-19 could also be triggering an entirely new type of diabetes in which certain cells mistakenly start to raise, rather than lower, blood sugar. The study adds to evidence showing an increased post-Covid-19 risk of cardiometabolic conditions, such as diabetes as well as heart and kidney complications. Normally when people think of long-term Covid-19 symptoms, they think of problems such as cognitive issues, fatigue or shortness of breath.
22nd Mar 2022 - The Wall Street Journal

CDC studies show COVID-19 vaccines remained effective during omicron surge

Two new studies from the Centers for Disease Control and Prevention show COVID-19 vaccines remained highly effective even during the omicron surge. They report vaccines still protected well against hospitalization, ventilation and death from COVID-19. At the peak of the omicron variant, data showed unvaccinated adults were 12 times more likely to be hospitalized.
21st Mar 2022 - ABC Columbia

Beijing developed new Omicron vaccines to defend against China’s worst COVID outbreak in two years—but it still has no mRNA shots

China’s domestic vaccine makers have reportedly developed new COVID shots that can better protect against Omicron, as the country battles its worst coronavirus outbreak since 2020. But despite evidence that mRNA vaccines—like the Comirnaty vaccine produced by BioNTech—offer better protection against Omicron infection, China is still relying on traditional inactive vaccines to guard against COVID. “As we expedite development of an Omicron vaccine, we consistently make safety and efficacy our No. 1 priority,” Zheng Zhongwei, an official who oversees COVID vaccine development at the National Health Commission, said during a media briefing on Saturday.
21st Mar 2022 - Fortune

Moderna inks COVID-19 booster supply deals, asks FDA to approve fourth shot for all adults

Moderna announced a new supply agreement with the Swiss federal government today for seven million doses of its COVID-19 booster vaccine for anticipated delivery in 2023.
21st Mar 2022 - BioPharma-Reporter.com

Cambodia ready to set up COVID-19 vaccine manufacturing plant

Cambodia is making all preparations to cooperate with China to set up a COVID-19 vaccine manufacturing plant, either by end of this year or 2023, said Secretary of State of the Cambodian Ministry of Health Youk Sambath. Khmer Times cited the official as saying that the ministry recently had a teleconference with the China National Pharmaceutical company (Sinopharm) and the Chinese Government on the plant establishment in Cambodia. The first round of discussion was fruitful and positive, she added. On late March 15, Cambodia received 523,100 doses of AstraZeneca vaccine donated by the Hungarian Government at Phnom Penh International Airport.
21st Mar 2022 - VietnamPlus

Safety and antibody responses to COVID-19 vaccines in an older community

Clinical trials and population-based studies of COVID-19 vaccines reveal exceptional safety and short-term efficacy. While clinical trials included older people aged over 70 years, the COVID-19 mortality rate was higher, particularly in those with comorbid conditions. In Canada, the interval between two vaccine doses was extended to allow immunization of more people, which raised concerns regarding the efficacy of vaccines. While studies noted the benefits of extended duration, little is known about that in the older population.
21st Mar 2022 - News-Medical.Net

Coronavirus may double severe complications in pregnancy

A Kaiser Permanente analysis of pregnant patients who tested positive for the coronavirus found more than double the risk of poor outcomes including preterm birth, venous thromboembolism (blood clot), and severe maternal morbidity, which includes conditions such as acute respiratory distress syndrome and sepsis. The study was published in JAMA Internal Medicine on March 21. An analysis of records for 43,886 pregnant individuals during the first year of the COVID-19 pandemic found that the 1,332 who had a coronavirus infection during pregnancy had more than double the risk of negative outcomes compared with individuals without the virus. “These findings add to the growing evidence that having COVID-19 during pregnancy raises risks of serious complications,” explained lead author Assiamira Ferrara, MD, PhD, a senior research scientist and associate director of the women’s and children health section in the Kaiser Permanente Division of Research.
21st Mar 2022 - EurekAlert!

'Reassuring' data suggests Johnson & Johnson vaccine may still have a role to play against Covid-19

The US public and even some health experts may have underestimated the Covid-19 vaccine made by Janssen, a division of Johnson & Johnson, new data shows. And there's emerging evidence that it could still play an important role ahead. A study published Thursday in the medical journal JAMA Network Open found that the J&J vaccine remains durable and effective, even through the surge of cases caused by the Delta variant. It was 76% effective overall in preventing Covid-19 infections and 81% effective in preventing Covid-related hospitalizations. The study also showed that it provided lasting immunity at least six months after the shots.
21st Mar 2022 - CNN

COVID-19 Drug Targets Immune Aging, Enters Phase II

Severe COVID-19 infections are more likely in older people, which is likely due to a deterioration of the immune system over time. The need for the development of COVID-19 therapies, especially for aging populations, is of paramount importance. A new study investigated an oral drug that reverses multiple aspects of immune aging. In doing so, the drug effectively prevents death in a mouse model of COVID-19, suggesting that the medication could be used to protect the elderly patients who are at greatest risk. In the study, daily doses of BGE-175 (asapiprant) protected aged mice from a lethal dose of SARS-CoV-2.
21st Mar 2022 - Genetic Engineering & Biotechnology News

Doctors finding hurdles to using pills to treat COVID-19

High-risk COVID-19 patients now have new treatments they can take at home to stay out of the hospital — if doctors get the pills to them fast enough. Health systems around the country are rushing out same-day prescription deliveries. Some clinics have started testing and treating patients in one visit, an initiative that President Joe Biden's administration recently touted. The goal is to get patients started on either Pfizer’s Paxlovid tablets or Merck’s molnupiravir capsules within five days of symptoms appearing. That can prevent people with big health risks from growing sicker and filling up hospitals if another surge develops. But the tight deadline has highlighted several challenges. Some patients are delaying testing, thinking they just had a cold. Others have been unwilling or unable to try the new drugs.
21st Mar 2022 - The Independent

COVID-19 Vaccine Manufacturers Submit Appeals to FDA for Fourth Dose

The makers behind two of the largest COVID-19 vaccines, Pfizer, BioNTech, and Moderna, are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines. Pfizer and BioNTech submitted an appeal to amend their Emergency Use Authorization (EUA) on March 15, 2022, while Moderna submitted one on March 17. Pfizer and BioNTech’s application is for a booster dose for adults 65 and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. According to a company press release, an analysis of Israeli Ministry of Health records found that confirmed infections were two times lower and rate of severe illness were four times lower among individuals who received an additional booster dose of the Pfizer-BioNTech COVID-19 vaccine administered at least four months after an initial booster dose relative to those who received only one booster dose.
21st Mar 2022 - BioPharm International

Link found between severe Covid-19 and long-term mental health problems

Serious Covid-19 illness appears to be linked to an increase in the risk of long-term adverse mental health effects, according to researchers from Scandinavia and the UK. They said it was the first study to look at long-term mental health implications for patients who were bedridden for more than a week following a diagnosis of Covid-19. Overall, most mental health symptoms among recovering Covid-19 subsided within two months after diagnosis, said the study authors in the journal The Lancet Public Health. But patients who were bedridden for seven days or more were more likely to experience depression and anxiety over the 16-month duration of the study, which involved data from six countries. This study was conducted by researchers from Iceland, Sweden, Norway, Denmark, Estonia, and the UK.
21st Mar 2022 - Nursing Times

Covid-19 news: Pfizer/BioNTech vaccine treats covid for first time

The Pfizer/BioNTech vaccine is thought to have helped an immunocompromised person clear the covid-19 virus. Two doses of the Pfizer/BioNTech vaccine are thought to have cleared the SARS-CoV-2 virus from a person who first tested positive more than 7 months earlier. This is the first known time a covid-19 vaccine has been used to treat, rather than prevent, the infection. Ian Lester has the rare genetic disease Wiskott-Aldrich syndrome, which weakens the immune system. Lester, 37, first tested positive for SARS-CoV-2 in December 2020. His immune system was unable to fight off the infection naturally for at least 218 days. “Given the persistent positive PCR tests and impact on his health and mental health, we decided on a unique therapeutic approach,” said Stephen Jolles at Cardiff University’s School of Medicine in a statement. “We administered two doses of the BioNTech Pfizer vaccine, one month apart, and very quickly saw a strong antibody response, much stronger than had been induced by the prolonged natural infection.” Lester was confirmed to have cleared SARS-CoV-2 72 days after the first vaccine dose and 218 days after his infection was detected.
21st Mar 2022 - New Scientist

Sinovac COVID vaccine shows modest efficacy against SARS-CoV-2 infection in children 3 to 5 years

In a new study under consideration at a Nature Portfolio Journal and published on the preprint server Research Square*, researchers investigated the efficacy of CoronaVac, a coronavirus disease 2019 (COVID-19) vaccine developed by Sinovac Biotech, in children aged three to five years. The findings of this study reveal that a two-dose regimen of the vaccine is highly effective in preventing severe COVID-19, whereas this vaccine regimen is modestly effective in preventing infection.
21st Mar 2022 - News-Medical.Net

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Mar 2022

View this newsletter in full

Oxford Covid jab gears up for final act: saving the rest of the world

Exactly two years ago Prof Sir Andrew Pollard was starting to panic. “We were just waking up to the reality of Covid-19 and that we would need vaccines for our very survival,” the director of the Oxford Vaccine Group told the Guardian last week. He joined forces with a colleague, Prof Dame Sarah Gilbert, and together they launched one of the greatest medical missions in modern history. Their seemingly impossible task – to design, develop and deliver a vaccine from scratch to slow the advance of a lethal pandemic – was completed in less than 12 months, to the relief of millions. Today though, the coronavirus landscape – and the status of their jab, ChAdOx1 nCoV-19 – looks very different. In the UK, half the population have had their vaccine, restrictions have ended, and while cases and hospitalisations are rising in the UK, a dramatic uptick in deaths is not expected.
20th Mar 2022 - The Guardian

Moderna files for emergency use of second Covid-19 booster shot

Moderna late on Thursday sought emergency use authorization from US health regulators for a second Covid-19 booster shot, as a surge in cases in some parts of the world fueled fears of another wave of the pandemic. The US biotechnology company said its request covered all adults over the age of 18 so that the appropriate use of an additional booster dose of its vaccine, including for those at higher risk of Covid-19 due to age or co-morbidities, could be determined by the Centers for Disease Control and Prevention (CDC) and healthcare providers.
20th Mar 2022 - The Guardian

HK’s Immunized Who Died of Covid Mainly Got Sinovac: Ming Pao

Almost 87% of Hong Kongers who died from Covid after getting at least one dose of vaccine received Sinovac Biotech Ltd.’s shot, Ming Pao reported, though most deaths occurred among those who weren’t immunized. The newspaper said it analyzed data from the Hospital Authority involving 5,167 of the city’s Covid fatalities, without disclosing its sources or additional information. It found that 71% of those who died were unvaccinated. Of the 1,486 who died after receiving at least one dose, 1,292 -- or 87% -- had gotten Sinovac, Ming Pao reported. Most deaths in Hong Kong have occurred among under-vaccinated senior citizens, particularly those living in elderly care homes.
20th Mar 2022 - Bloomberg

Moderna seeks FDA authorization for second COVID booster for all adults

Moderna Inc on late Thursday sought emergency use authorization from U.S. health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic. The U.S. biotechnology company said its request covered all adults over the age of 18 so that the appropriate use of an additional booster dose of its vaccine, including for those at higher risk of COVID-19 due to age or comorbidities, could be determined by the U.S. Centers for Disease Control and Prevention (CDC) and health care providers. Moderna's request is significantly broader than Pfizer Inc and its German partner BioNTech SE's application that was filed earlier this week with U.S. regulators for a second booster shot for people aged 65 and older
20th Mar 2022 - Reuters

CDC reports fewer COVID-19 pediatric deaths after data correction

The U.S. Centers for Disease Control and Prevention reported 966,575 deaths from COVID-19 on Friday after it corrected the data earlier this week, which reduced the death tallies in all age-groups, including children. The health agency, in a statement to Reuters, said it made adjustments to its COVID Data Tracker's mortality data on March 14 because its algorithm was accidentally counting deaths that were not COVID-19-related. The adjustment resulted in removal of 72,277 deaths previously reported across 26 states, including 416 pediatric deaths, CDC said. The reduction cut the CDC's estimate of deaths in children by 24% to 1,341 as of March 18.
20th Mar 2022 - Reuters

Neurological problems no higher after vaccination; depression, anxiety risk tied to COVID severity

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Neurological risks not higher after COVID-19 vaccines COVID-19 vaccination did not increase risks for rare neurological conditions among more than 8 million people who had received at least one dose of a vaccine from AstraZeneca, Pfizer /BioNTech, Moderna or Johnson & Johnson, according to researchers. Their study also included 735,870 unvaccinated individuals who had tested positive for the coronavirus, as well as older data on an additional 14.3 million people from the general population for a baseline estimate of rates of the neurological conditions before the pandemic
20th Mar 2022 - Reuters

Canadian Pfizer partner sues to head off patent lawsuit over COVID-19 vaccine

The biotech company that makes mRNA-delivery technology for Pfizer's COVID-19 vaccine sued Arbutus Biopharma Corp in Manhattan federal court on Friday, seeking to head off claims that the vaccine infringes Arbutus' patents. Canada-based Acuitas Therapeutics Inc said Arbutus and partner Genevant Sciences have threatened to sue for potentially billions of dollars in "unjustified royalties" over the vaccine Pfizer developed with Germany's BioNTech SE . Acuitas asked the court to find that the Pfizer/BioNTech vaccine does not infringe Arbutus patents and that several Arbutus patents are invalid.
20th Mar 2022 - Reuters

China Says Vaccine Makers Upgraded Shots to Fight Omicron

Chinese officials said vaccine makers have upgraded their Covid-19 vaccines against the omicron variant and other strains but new shots will be validated for safety and efficacy before they can be rolled out. Widely-used inactivated shots in the country have been tweaked to fight up to three variants, including omicron and the preceding predominant delta strain, according to Zheng Zhongwei, an official who oversees Covid vaccine development at the National Health Commission. Another protein subunit shot targeting four variants is seeking approval for human testing overseas, he said. “We share the urgent wish of everybody to use omicron target vaccines,” Zheng said at a briefing in Beijing Saturday. “As we expedite development of omicron vaccine, we consistently make safety and efficacy our No. 1 priority.”
20th Mar 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Mar 2022

View this newsletter in full

Alnylam sues Pfizer and Moderna for patent infringement in development of Covid-19 vaccines

Alnylam Pharmaceuticals has filed separate lawsuits alleging that Pfizer and Moderna infringed on its patents in developing their Covid-19 vaccines, the latest dispute over valuable intellectual property stemming from the pandemic. In each suit, Alnylam claims the companies used its lipid nanoparticles technology that carries and delivers RNA-based therapies or vaccines in the body. RNA plays a key role in turning the instructions held in the DNA of a person’s genome into functional proteins in cells. Both Pfizer and Moderna developed and now market mRNA-based vaccines, and mRNA is a type of RNA. However, mRNA is easily degraded and the lipid technology provides protection for delivery.
17th Mar 2022 - STAT

COVID-19 Vaccine Produced by Yeast Could Increase Accessibility

In a new paper, the researchers report that the vaccine, which comprises fragments of the SARS-CoV-2 spike protein arrayed on a virus-like particle, elicited a strong immune response and protected animals against viral challenge. The vaccine was designed so that it can be produced by yeast, using fermentation facilities that already exist around the world. The Serum Institute of India, the world’s largest manufacturer of vaccines, is now producing large quantities of the vaccine and plans to run a clinical trial in Africa. “There's still a very large population that does not have access to Covid vaccines. Protein-based subunit vaccines are a low-cost, well-established technology that can provide a consistent supply and is accepted in many parts of the world,” says J. Christopher Love, the Raymond A. and Helen E. St. Laurent Professor of Chemical Engineering at MIT and a member of the Koch Institute for Integrative Cancer Research and the Ragon Institute of MGH, MIT, and Harvard.
17th Mar 2022 - Technology Networks

WHO postpones evaluation of Russia's Sputnik V coronavirus vaccine

The World Health Organization said Wednesday its evaluation of Russia's Sputnik V coronavirus vaccine has been postponed for the time being, due to the "uneven situation." WHO vaccines expert Dr. Mariangela Simao said at a press briefing that the UN health agency's officials had originally been scheduled to visit Russia on March 7 — just weeks after Russia invaded Ukraine — to assess the facilities where Sputnik V is produced. "These inspections were postponed for a later date," Simao said. "The assessment, along with inspections, have been affected because of the situation.
17th Mar 2022 - CBC News

EMA expects data on Omicron-specific vaccine as early as April

The European Medicines Agency's (EMA) leading vaccine expert on Thursday said that data on COVID-19 vaccines tailored for the Omicron variant should be available between April and the start of July, potentially paving the way for approval this summer. Vaccine makers such as Moderna and Pfizer have begun testing COVID-19 vaccines designed to target Omicron after data showing that two initial COVID-19 vaccine doses provide only partial protection against the variant. Based on data for Omicron-specific vaccines, the agency will decide on a timeline for the potential granting of approval.
17th Mar 2022 - Reuters

Fourth vaccine offers little protection against COVID-19 - study

The fourth coronavirus vaccine has shown to offer little protection against the coronavirus, a new study released by Sheba Medical Center has shown. The study, published by The New England Journal of Medicine, examines the efficacy of the fourth coronavirus vaccine from Pfizer and Moderna. The interim results released show that the vaccine offers little to no protection against contracting the virus when compared to young and healthy individuals vaccinated with three doses. However, the vaccine did prove to provide moderate protection against symptomatic infection among young and healthy individuals in comparison to those inoculated three times.
17th Mar 2022 - The Jerusalem Post

Omicron BA.2 variant triggers COVID-19 surge in England

The new sub-variant, named Deltacron, combines mutations from both Omicron and Delta. The variant has been detected in multiple areas of France, and cases have doubled in China and tripled in parts of Australia. In England there has been a surge in COVID-19 infections, with case numbers rising by 49.2% in a week. There has also been a rise of 20.9% in patients admitted to hospital for COVID-19-related illness in the past week. However, there has also been a decrease in fatality rates of 4.4%. Currently only a small number of cases of the new variant have been identified and it is not yet known what level of protection vaccines will provide against this sub-variant.
17th Mar 2022 - PharmaTimes

Altered immune cells in lungs may cause breathlessness after Covid-19

A study has found abnormal immune cells in the lungs of patients with persistent breathlessness months after a Covid-19 infection. The altered immune cells in the airways are thought to cause ongoing lung damage. The research was undertaken by scientists at Imperial College London and involved people who had been previously hospitalised with Covid-19. The findings, published in Immunity, suggest that recovery from Covid-19 infection might be accelerated by treatments that dampen the immune system and reduce inflammation. Professor Pallav Shah, a joint senior author of the study from Imperial College, said: ‘These findings suggest that persistent breathlessness in our group of Covid-19 patients is being caused by failure to turn off the immune response, which leads to airway inflammation and injury.’
17th Mar 2022 - Nursing in Practice

Alnylam sues Pfizer, Moderna over COVID-19 vaccines

Alnylam claims it is owed a slice of the massive revenues booked by Pfizer and Moderna for their mRNA-based COVID-19 vaccines, because they are both infringing patents its holds on a delivery technology. The US biotech has filed a pair of lawsuits in Delaware alleging infringement of US Patent No 11,246,933, which covers lipid nanoparticles (LNPs) made from cationic and PEG lipids that can be used to deliver active agents “such as a nucleic acid.” In an SEC filing, Alnylam said it is seeking a judgment that Pfizer and Moderna have infringed the patent, along with compensation at last equal to “a reasonable royalty for the unlicensed uses made of Alnylam’s patented lipids by Pfizer and Moderna, together with interest and costs as may be awarded by the court.”
17th Mar 2022 - Pharmaphorum

Covid-19: Pfizer asks US regulator to authorise fourth vaccine dose for over 65s

Pfizer and BioNTech have applied to the US Food and Drug Administration for emergency use authorisation for a fourth dose of its mRNA vaccine against covid-19 for adults aged 65 and older. The companies said that the additional dose reduced the rates of infection and severe illness in older adults. In a press release they said that they were seeking the new approval for adults over 65 who had received an initial booster of any of the authorised or approved covid-19 vaccines. Pfizer-BioNTech said that the request was based on “two real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating. These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness.” The companies said that an analysis of Israeli Ministry of Health records was conducted on over 1.1 million adults aged 60 and over who had no known history of SARS-CoV-2 infection and were eligible for a fourth vaccine dose. They wrote, “These data showed rates of confirmed infections were two times lower and rates of severe illness were four times lower among individuals who received an additional booster dose of the Pfizer-BioNTech covid-19 vaccine administered at least four months after an initial booster (third) dose compared to those who received only one booster dose.”
17th Mar 2022 - The BMJ

Generic drugmakers sign on to make cheap version of Pfizer COVID pill

Thirty five generic drugmakers around the world will make cheap versions of Pfizer Inc's highly effective COVID-19 oral antiviral Paxlovid to supply the treatment in 95 poorer countries, the U.N.-backed Medicines Patent Pool (MPP) said on Thursday. Pfizer struck a deal last year with the group to allow generic drugmakers to make the pills for 95 low- and middle-income countries. They have been working since then to select the drugmakers they will license. Paxlovid is expected to be an important tool in the fight against COVID-19 after it reduced hospitalizations in high-risk patients by around 90% in a clinical trial. The results were significantly better than those for Merck & Co's rival antiviral pill molnupiravir in its clinical trial.
17th Mar 2022 - Reuters

UK approves AstraZeneca's antibody-based COVID treatment

Britain's medicines regulator has approved AstraZeneca's antibody-based COVID-19 treatment for preventing infections in adults with poor immune response, marking a major step in the fight against the pandemic as infections surge globally. The decision to grant approval for the treatment, Evusheld, was endorsed by the government's independent scientific advisory body, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) said on Thursday. Figures showing a global rise in COVID-19 cases could herald a much bigger problem, the World Health Organization said this week, warning nations to remain vigilant.
17th Mar 2022 - Reuters

More than 30 companies to start making Pfizer’s COVID pill

Nearly three dozen companies worldwide will soon start making generic versions of Pfizer’s coronavirus pill, the U.N.-backed Medicines Patent Pool that negotiated the deal said Thursday. The Medicines Patent Pool said in a statement that agreements signed with 35 companies should help make Pfizer’s antiviral nirmatrelvir, or Paxlovoid, available to more than half of the world’s population. Generic drugmakers across a dozen countries in Asia, the Caribbean, the Middle East and Eastern Europe will begin producing either the raw ingredients for the Pfizer drug or the pill itself. Among the companies offered a license was one in Ukraine, which has not yet been able to confirm it can participate. “This will make an enormous difference for countries.” said Charles Gore, executive director of the Medicines Patent Pool. He said the availability of the Pfizer drug in some of the world’s poorest countries is especially critical. “They have been at the back of the queue for vaccines, so having a treatment like this in the armory will be absolutely critical to prevent deaths.”
17th Mar 2022 - The Associated Press

Severe COVID-19 tied to long-term depression, anxiety

A new observational follow-up study in six European countries published in The Lancet Public Health links severe COVID-19 to long-term depression and anxiety. University of Iceland at Reykjavik researchers led the study, which analyzed symptoms of depression, anxiety, COVID-related stress, and poor sleep quality among 247,249 adults, 4% of whom were diagnosed as having COVID-19 from Mar 27, 2020, to Aug 13, 2021. Participants, who were followed up for as long as 16 months (average, 5.7), lived in Denmark, Estonia, Iceland, Norway, Sweden, or the United Kingdom. Most severely ill COVID-19 patients recuperated at home, but some spent time in a hospital.
16th Mar 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Mar 2022

View this newsletter in full

Can Covid Infection Increase the Risk of Type 2 Diabetes? Study Suggests Link

Covid-19 infection appears to be linked to an increased risk of type 2 diabetes, a study suggests. But Diabetes UK said there is "still work to do to unpick the link between the two conditions". Researchers from Germany have associated the two ailments in a new paper which explores people's risk of being diagnosed with type 2 after they have had Covid. The study, published in the journal Diabetologia, examined data from more than 1,000 GP surgeries in Germany caring for a population of almost nine million patients. Between March 2020 and January 2021 there were 35,865 people with a documented case of Covid-19.
17th Mar 2022 - Bloomberg

WHO expert says Covid-19 comes in waves of four months

The Department of Health has reported 5,452 PCR-confirmed cases of Covid-19 and 8,644 positive antigen tests recorded through the HSE portal. As of 8am today, 1,081 Covid-19 patients were in hospital, with 44 being treated in ICU. In Northern Ireland, five more people who had previously tested positive for Covid-19 have died, the Department of Health said. Another 2,391 confirmed cases of the virus have also been notified in the last 24-hour reporting period. This morning, there were 515 Covid-19 patients in hospital, with four in intensive care. Taoiseach Micheál Martin has said there is concern about the increase in Covid-19 cases.
16th Mar 2022 - RTE.ie

Pets and COVID-19: Experts say vigilance needed but risks small

A pet sneezes, its nose is runny, and it seems sluggish. Could it be a normal pet illness like a cold – which can be caught by dogs and cats from human owners – or could it be COVID-19? It is a question that has sat uncomfortably on the minds of many pet owners throughout the pandemic and was resurrected again in January when authorities in Hong Kong culled hundreds of hamsters and other small animals following an outbreak of the Delta variant traced to a pet shop and warehouse.
16th Mar 2022 - Al Jazeera English

Omicron sub-variant makes up 23.1% of COVID variants in U.S. - CDC

The BA.2 sub-variant of Omicron was estimated to be 23.1% of the coronavirus variants circulating in the United States as of March 12, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday. Scientists are tracking a rise in cases caused by BA.2, which is spreading rapidly in parts of Asia and Europe. According to the CDC's data, the sub-variant now makes up 39% of total cases in regions including New Jersey, New York, Puerto Rico and Virgin Islands. In states such as Connecticut, Maine, Massachusetts, New Hampshire, Vermont and Rhode Island, the sub-variant now makes up about 38.6% of total cases.
16th Mar 2022 - Reuters

Sinovac COVID vaccine 38% effective in young kids - Chilean study

China-based Sinovac Biotech Ltd's COVID-19 vaccine was 38.2% effective in preventing infections during the Omicron wave in children aged three to five years, a study in Chile showed. The study, published on Tuesday, has not yet been peer reviewed. The findings are in contrast to earlier studies that showed the vaccine, CoronaVac, was 74.5% effective in preventing infections in children aged 6 to 16 years, when Delta was the dominant variant. Countries are increasingly recommending booster doses in the face of the circulating Omicron variant, which the World Health Organization has said can bypass some protection imparted by vaccines. Most vaccines are still effective against severe infections.
16th Mar 2022 - Reuters

Pfizer-BioNTech seek U.S. OK for second COVID booster for 65 and older

Pfizer Inc and its German partner BioNTech SE an application with U.S. regulators seeking emergency use authorization for a second booster shot of their COVID-19 vaccine for people aged 65 and older. The submission to the U.S. Food and Drug Administration includes data collected in Israel, where a second booster is authorized for many people over age 18. read more An analysis of data from over a million adults 60 years and older showed rates of confirmed infections and severe illness were lower among individuals who received an additional booster dose of the vaccine administered at least four months after an initial booster (third) dose compared to those who received only one booster dose, the companies said.
16th Mar 2022 - Reuters

Europe begins reviewing application for AstraZeneca COVID drug

Europe's drug regulator said on Tuesday it had begun reviewing AstraZeneca Plc's application for antibody-based COVID-19 therapy, a key step towards approval of the treatment in the region, but gave no timeline for a conclusion. Infections from COVID-19 are still rising in parts of the world including Europe. China posted a steep jump in daily COVID-19 infections on Tuesday, with new cases more than doubling from a day earlier to hit a two-year high. AstraZeneca's antibody cocktail, Evusheld, has already been authorised in the United States to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.
16th Mar 2022 - Reuters

Even with omicron, coronavirus vaccines have been enormously effective

The good news is that Hong Kong’s spike in coronavirus cases has begun to fade. The bad news is that, before it did, Hong Kong had one of the highest population-adjusted death tolls seen anywhere in the world since the pandemic began. In a remarkable series of tweets Monday, the Financial Times’s John Burn-Murdoch illustrated the dire situation in Hong Kong since the beginning of February. He contrasted its spike in cases with a similar increase in New Zealand — but then pointed out the wide divergence in the number of those cases that resulted in death. (Notice that he shifted the case totals to align with the increase in deaths, so his graphs depict cases still rising.)
16th Mar 2022 - Washington Post

Diabetes & COVID-19: Scientists explore potential connection

When their 11-year-old son started losing weight and drinking lots of water, Tabitha and Bryan Balcitis chalked it up to a growth spurt and advice from his health class. But unusual crankiness and lethargy raised their concern, and tests showed his blood sugar levels were off the charts. Just six months after a mild case of COVID-19, the Crown Point, Indiana, boy was diagnosed with Type 1 diabetes. His parents were floored — it didn’t run in the family, but autoimmune illness did and doctors said that could be a factor. Could his diabetes also be linked with the coronavirus, wondered Nolan’s mom, a respiratory therapist. Turns out scientists in the U.S. and elsewhere are asking the same question and investigating whether any connection is more than a coincidence. It’s clear that in those who already have diabetes, COVID-19 can worsen the condition and lead to severe complications. But there are other possible links
16th Mar 2022 - The Associated Press

Severe COVID-19 tied to long-term depression, anxiety

Newborns Catching Covid From Mothers Is 'Rare', UK Researchers Say

The risk of women passing on Covid-19 to their newborn babies is "low", according to a new study. The chance of transmitting the virus while pregnant, during labour, or after the baby is born is less than 2%, researchers said. When proper preventive steps are taken after a mother tests positive, such as the use of face masks, "infection of newborn babies is unlikely", they concluded. Academics led by experts from the University of Birmingham reviewed data from 472 global studies, which looked at data on 952 mothers and 18,237 babies. Across the world, just 1.8% of the 14,271 babies born to mothers with Covid-19 went on to test positive themselves, the study, published in The BMJ, found.
16th Mar 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Mar 2022

View this newsletter in full

Pfizer-BioNTech seek U.S. OK for second COVID booster for 65 and older

The submission to the U.S. Food and Drug Administration includes data collected in Israel, where a second booster is authorized for many people over age 18. An analysis of data from over a million adults 60 years and older showed rates of confirmed infections and severe illness were lower among individuals who received an additional booster dose of the vaccine administered at least four months after an initial booster (third) dose compared to those who received only one booster dose, the companies said.
16th Mar 2022 - Reuters

Pfizer Asks FDA to Authorize Second Covid-19 Booster Dose

Pfizer Inc. and partner BioNTech SE have asked U.S. health regulators to authorize a second booster dose of their Covid-19 vaccine for people 65 years and older. The companies said Tuesday that they had filed the application. The Food and Drug Administration is expected to make a decision in time for the Biden administration to begin a potential fall vaccine campaign. The FDA has been reviewing data and looking at potentially authorizing a fourth dose of the shot for use in the fall, The Wall Street Journal reported last month. Health authorities have cleared booster doses for children as young as 12 years of age, at least five months after they finished their first round of vaccination.
16th Mar 2022 - The Wall Street Journal

Novavax Covid vaccine now available in Netherlands

The Novavax protein-based vaccine against the coronavirus is now available in the Netherlands. "The Novavax vaccine can be an alternative for people who are hesitant about inoculation with an mRNA or vector vaccine," public health institute RIVM said on its website. People who want to get a Novavax shot can make an appointment with the GGD at telephone number 0800-0174. The Novavax vaccine contains tiny particles with the coronavirus' spike protein, which was counterfeited in the laboratory. It also contains an adjuvant that enhances the body's immune response to this protein. The body will produce antibodies against the spike protein after injection. If the body later comes into contact with SARS-CoV-2, the immune system will recognize the spike protein and produce antibodies to fight it, according to the RIVM.
15th Mar 2022 - NL Times

Merck’s Covid-19 Pill Heavily Used So Far Despite Concerns

A new Covid-19 pill from Merck & Co. and Ridgeback Biotherapeutics LP has been more widely used than expected since rolling out late last year, though regulators and many doctors consider it a last resort. Many doctors and health officials anticipated a rival pill, Pfizer Inc.’s Paxlovid, would be the Covid-19 drug of choice. Paxlovid was found to be far more effective than Merck-Ridgeback’s molnupiravir in clinical trials, and regulators and guidelines recommended using Paxlovid if possible. Prescriptions for the two antivirals have been running about equal since their authorization in December, however. The larger-than-expected use is a sign of the high demand for easy-to-use coronavirus treatments that can be taken at home, especially during surges like the recent Omicron wave.
15th Mar 2022 - The Wall Street Journal

Scientists link ‘severe’ Covid-19 to long-term mental health problems

People who suffer from severe Covid-19 symptoms are more likely to have long-term mental health problems, a new study suggests. Higher rates of depression and anxiety have been found in people who were “bedridden” with Covid-19 for more than seven days last year, according to a study published in The Lancet. Scientists, drawing on data from 247,249 people across the UK, Denmark, Estonia, Iceland, Norway and Sweden, found that people with coronavirus who were not admitted to hospital were more likely to experience symptoms of depression up to 16 months after diagnosis, compared to those never infected.
15th Mar 2022 - The Independent

A quarter of symptomatic kids hit by long COVID; mRNA shots provide best protection in breast milk

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. One in four kids with COVID develop lingering problems One in four children with COVID-19 symptoms develop "long COVID," according to data pooled from 21 earlier studies conducted in Europe, Asia, Australia and South America. Among the 80,071 children with COVID-19 in the studies, 25% developed symptoms that lasted at least 4-to-12 weeks or new persistent symptoms that appeared within 12 weeks, researchers reported on Sunday on medRxiv ahead of peer review.
15th Mar 2022 - Reuters

Top Pfizer, Moderna execs at odds on need for 4th COVID-19 vaccine dose

Top executives at pandemic juggernauts Pfizer and Moderna are at odds on the need for a fourth COVID-19 vaccine dose. One says a second booster is needed “right now,” while the other thinks a fourth mRNA shot may only be essential for older adults and the immunocompromised. Pfizer CEO Albert Bourla, Ph.D., for his part, thinks another booster is needed as soon as possible. While a third dose of the company’s mRNA-based shot Comirnaty offers protection against severe disease, it may not be enough to stave off infection, CEO Albert Bourla told CBS News’ "Face the Nation." Based on what Pfizer has seen, it's "necessary" for a "a fourth booster right now,” Bourla said over the weekend.
15th Mar 2022 - FiercePharma

Prognosis U.S. Sewer Data Warns of a New Bump in Covid Cases After Lull

A wastewater network that monitors for Covid-19 trends is warning that cases are once again rising in many parts of the U.S., according to an analysis of Centers for Disease Control and Prevention data by Bloomberg. More than a third of the CDC’s wastewater sample sites across the U.S. showed rising Covid-19 trends in the period ending March 1 to March 10, though reported cases have stayed near a recent low. The number of sites with rising signals of Covid-19 cases is nearly twice what it was during the Feb. 1 to Feb. 10 period, when the wave of omicron-variant cases was fading rapidly. It’s not clear how many new infections the signs in the sewage represent and if they will turn into a new wave, or will be just a brief bump on the way down from the last one. In many parts of the country, people are returning back to offices and mask rules have been loosened — factors that can raise transmission.
15th Mar 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Mar 2022

View this newsletter in full

Serious Covid Linked to Higher Risk of Depression Months Later

Serious Covid-19 was linked to a higher risk of depression and anxiety months later in a large study, adding to a growing body of data showing the impact the disease can have on mental health. People who were bedridden for at least seven days were about 60% more likely to experience symptoms of depression, according to the study, published in The Lancet Public Health. That contrasts with those who had Covid but weren’t bedridden, who were less likely to experience depression and anxiety than people who never had the disease at all. The study “suggests that mental health effects aren’t equal for all Covid-19 patients,” said Unnur Anna Valdimarsdottir, a professor of epidemiology at the University of Iceland who helped lead the research.
15th Mar 2022 - Bloomberg

A 4th dose of Covid-19 vaccine will be needed, Pfizer's CEO says, but the company is working on a shot to handle all variants

To help fend off another wave of Covid-19, people will need a fourth dose of vaccine, Pfizer CEO Albert Bourla told CBS on Sunday. "Many variants are coming, and Omicron was the first one that was able to evade -- in a skillful way -- the immune protection that we're giving," Bourla told CBS' "Face the Nation." "The protection we are getting from the third (dose) it is good enough -- actually quite good for hospitalizations and deaths," Bourla said.
14th Mar 2022 - CNN

Philippines FDA grants approval to Sinovac's paediatric Covid-19 vaccine

The Food and Drug Administration (FDA) of the Philippines has granted emergency use authorization (EUA) to Chinese firm Sinovac’s Covid-19 vaccine, CoronaVac, for use in paediatric individuals, CNN Philippines reported. According to the approval, the vaccine is intended for immunisation of children aged six years and above against Covid-19. Pharmaceutical consortium IP Biotech Group aided in the initial delivery of the private sector-procured Sinovac vaccines. Philippine News Agency (PNA) quoted IP Biotech Group chairman Enrique Gonzales as saying in a statement: “Making this vaccine available to the younger age segment is a game-changer protecting the country’s youth and preserving recent gains in controlling the pandemic. This will also ensure greater access and vaccine equity for the Philippines.”
14th Mar 2022 - Pharmaceutical Technology

War in Ukraine could make the Covid-19 pandemic worse, WHO says

The World Health Organization (WHO) said Sunday it is concerned the war in Ukraine could worsen the Covid-19 pandemic, and it is trying to do more to limit the spread of infectious diseases. Cases in the region are down from the previous week, but there's significant risk there will be more severe disease and death due to low vaccination rates in Ukraine, as well as among the more than two million who've fled the country to surrounding areas, regions also with low vaccination rates. Ukraine's Covid-19 vaccination rate is around 34%, while neighboring Moldova's is around 29%, according to Our World In Data. There have been a total of 791,021 new cases of Covid-19 and 8,012 new deaths in Ukraine and in surrounding countries between March 3 and 9, a WHO situation report published Sunday said. "Unfortunately, this virus will take opportunities to continue to spread," said Maria Van Kerkhove, WHO's technical lead on Covid-19, during a Wednesday news briefing. "
14th Mar 2022 - CNN

For kids with COVID-19, everyday life can be a struggle

Eight-year-old Brooklynn Chiles fidgets on the hospital bed as she waits for the nurse at Children's National Hospital. The white paper beneath her crinkles as she shifts to look at the medical objects in the room. She's had coronavirus three times, and no one can figure out why. Brooklynn's lucky, sort of. Each time she has tested positive, she has suffered no obvious symptoms. But her dad, Rodney, caught the virus — possibly from her — when she was positive back in September, and he died from it. Her mom, Danielle, is dreading a next bout, fearing her daughter could become gravely ill even though she's been vaccinated. “Every time, I think: Am I going to go through this with her, too?" she said, sitting on a plastic chair wedged in the corner. "Is this the moment where I lose everyone?"
14th Mar 2022 - The Independent

Covid-19 vaccine ‘reduces infections in children’ – study

A single dose of the Pfizer Covid-19 vaccine can reduce infections among children, a new study suggests. And if a child gets Covid-19 after being vaccinated they are “likely to have a milder disease”, researchers from King’s College London and ZOE Ltd said. While the Covid-19 vaccines have been shown to ward off serious disease and death, questions have arisen over their ability to reduce the spread of infections. The latest study examined the effectiveness of a single dose of the Pfizer/BioNTech Covid vaccine in children.
14th Mar 2022 - Evening Standard

Novavax's COVID vaccine rollout in EU off to a slow start

Demand for the COVID-19 vaccine produced by U.S. biotech firm Novavax has been underwhelming in the European Union's main countries in the early rollout, so far undermining hopes that it could convince vaccine sceptics to get a shot. Over 85% of adults in the 27-country EU bloc have received at least one dose and nearly two-thirds of them have also had a booster, but tens of millions remain unvaccinated. The Novavax vaccine, the latest to receive the EU regulators' approval under the trade name of Nuvaxovid, was expected to persuade some sceptics because it is based on a more conventional technology than the other four vaccines authorised so far in the EU.
14th Mar 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Mar 2022

View this newsletter in full

What is Deltacron? Everything you need to know about the new Covid-19 variant

A fresh reminder that the pandemic is not yet over comes as new Covid-19 variant Deltacron is officially identified with cases confirmed in France and the US. Here is everything you need to know about the new Covid variant. What is Deltacron? Deltacron is a Covid variant that is made up of elements from both Delta and Omicron. It contains genes from both of these previous variants, which makes it a recombinant virus. This is when the genetic material from more than one origin is combined- in other words, when someone is infected with two variants at the same time and their cells then replicate together.
12th Mar 2022 - The Independent

GeoVax vaccine targeting virus in two places shows promise; virus may become resistant to antibody drugs

An experimental vaccine developed by GeoVax Labs Inc succeeded in promoting development of antibodies that target two different sites on the virus in a small pilot study and has been advanced to mid-stage clinical trials, researchers reported. Like currently available COVID-19 vaccines, GeoVax's GEO-CM04S1 induces immune responses that target the spike protein on the surface of the virus. But it also targets the "nucleocapsid," or body, of the virus. In the study reported on Wednesday in The Lancet Microbe, 56 volunteers received the vaccine, which uses a modified version of a harmless virus to deliver instructions to the immune system. Overall, 94% developed antibodies against the spike and the nucleocapsid protein, according to the research team from City of Hope National Medical Center in Duarte, California.
12th Mar 2022 - Reuters

Valneva now expects recommendation on COVID-19 vaccine by April

Valneva now expects a positive recommendation from the European Medicines Agency (EMA) in April for its VLA2001 COVID-19 candidate vaccine, the French vaccine maker said on Friday, compared to an earlier target for the end of March. "Following such conditional approval, the company would expect to start delivering planned doses of VLA2001 to European countries in the second quarter of 2022," said Valneva. It cited a "a small set of additional questions" from the EMA as reason for the delay, adding it was set to respond within days.
12th Mar 2022 - Reuters

Omega Diagnostics' COVID test rejected for sale in UK; shares fall

Omega Diagnostics Group Plc said on Friday its COVID-19 antigen test kit had not been approved by the UK health security agency and the product would not be available for sale in the country, sending its shares tumbling more than 20%. Late last year, a new review system came into force under which COVID-19 test suppliers had to submit information on comparator tests for their products for a "desktop review" if they wished to remain on sale in Britain. Omega said some data submitted before the new review had to be excluded in the latest evaluation, as they did not meet the sensitivity requirements, leading to insufficient data for an approval. It added that no further tests were planned at this time.
12th Mar 2022 - Reuters

England's COVID R number rises, cases could be growing

The estimated range of England's COVID-19 reproduction "R" number is between 0.8 and 1.1, the UK Health Security Agency said on Friday, adding that daily cases could be growing each day. An R number between 0.8 and 1.1 means that for every 10 people infected, they will on average infect between 8 and 11 other people. The previous week's range was 0.8 to 1.0. The daily growth of infections was -2% to +2%, compared to an estimated range of between -4% to -1% last week.
12th Mar 2022 - Reuters

Japan's Fujifilm to halt enrollment in Avigan trial for COVID-19

A drug once hailed as Japan's biggest contribution in the global fight against COVID-19 suffered another setback on Friday, as Fujifilm Holdings Corp said it was halting enrolment in a clinical trial of the pill, Avigan. The emergence of the Omicron variant of coronavirus, which usually causes milder infections, made it tough to determine the drug's effectiveness in preventing severe symptoms, the company said in a statement. Clinical data from patients already enrolled in the trial will continue to be analysed, it said.
11th Mar 2022 - Reuters

What is the Deltacron variant of Covid and where has it been found?

Gisaid says the variant has been identified in several regions of France and appears to have been circulating since the start of the year. “Genomes with a similar profile have been also identified in Denmark and the Netherlands,” Gisaid says. There have also been reports of Deltacron being detected in the US, and about 30 cases have been detected in the UK, according to the UK Health Security Agency (UKHSA). The i newspaper said the first cases of person-to-person transmission of Deltacron in the UK were expected to be confirmed this week. Dr Etienne Simon-Loriere of the Institut Pasteur cautioned that there could be several different recombinant viruses formed from Delta and Omicron.
11th Mar 2022 - The Guardian

Two years of COVID: The battle to accept airborne transmission

For Catherine Noakes, a scientist who studies how pathogens move in the built environment, the first few months of the coronavirus pandemic were punctuated with a foreboding sense of frustration. That frustration was rooted in the readily accepted assumption that COVID-19 was not spreading through the air via microscopic particles called aerosols, but predominantly through larger respiratory droplets expelled among people in close proximity and falling quickly on nearby surfaces. The World Health Organization (WHO) — which sets the tone for many nations — early on denied COVID-19 was spreading through these tiny aerosols suspended in air. As evidence mounted, alongside pressure from scientists like Noakes, the agency eventually acknowledged the possibility of airborne transmission — but continued to downplay its significance in favour of droplets, placing a heavy emphasis on handwashing and disinfecting surfaces instead of more stringent measures. Then as evidence suggesting the virus behind COVID-19 was primarily airborne grew to be overwhelming, the agency finally admitted in December 2021 that the virus could indeed be spreading via aerosols.
11th Mar 2022 - Al Jazeera English

Covid treatment sotrovimab can cause drug-resistant mutation, study finds

Australian virologists have uncovered a drug-resistant mutation in the Covid-19 virus associated with the drug sotrovimab and say without the monitoring of patients given the treatment the mutated virus could spread in the community. The world-first findings, published in the New England Journal of Medicine on Thursday, are the result of an analysis of the first 100 patients in western Sydney during the Delta outbreak in 2021 to be given sotrovimab. Sotrovimab is a monoclonal antibody that is available in many countries to treat vulnerable patients who are at risk of severe disease and death due to Covid-19 infection. Sotrovimab must be administered via infusion within the first five days of Covid-19 infection, and prevents Covid-19 symptoms from becoming severe. It is one of the few human-engineered monoclonal antibodies that can target Omicron.
10th Mar 2022 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Mar 2022

View this newsletter in full

COH04S1 COVID-19 vaccine shown to produce robust antibodies and T cells against SARS-CoV-2

A COVID-19 investigational vaccine, developed by City of Hope scientists and now licensed to GeoVax Labs Inc produced a robust neutralizing antibody and T cell (an immune cell) response against SARS-CoV-2 with no significant side effects in a Phase 1 clinical trial led by John Zaia, M.D., Aaron D. Miller and Edith Miller Chair for Gene Therapy, according to a study published today in The Lancet Microbe. COH04S1 is uniquely different than the many vaccines that have been developed because it targets both the spike and nucleocapsid proteins, in contrast to the current U.S. Food and Drug Administration (FDA)-approved COVID-19 vaccines, which only target the spike protein.
10th Mar 2022 - Medical Xpress

J&J inks vaccine licensing deal with Aspen, paving the way for Africa's first local COVID-19 shot

South Africa’s Aspen has clinched its COVID-19 vaccine licensing deal with Johnson & Johnson in a move the company last year said could be a “game-changer” on the path to Africa’s vaccine sovereignty. Under the deal, Aspen will be able to manufacture and distribute J&J’s COVID shot in Africa, with the goal to boost COVID-19 vaccination rates across the continent, J&J said in a release. Specifically, the South African manufacturer will receive drug substances from J&J, which it will use to produce finished, Aspen-branded vaccines for the African public sector. Aspen will make the shots available to all 55 African Union member states, plus multilateral organizations supporting Africa’s COVID-19 vaccination efforts, such as the African Vaccine Acquisition Trust and the COVAX Facility.
10th Mar 2022 - FiercePharma

Incidence of myocarditis and pericarditis following COVID-19 vaccination

Several vaccine candidates have been developed following the onset of the coronavirus disease 2019 (COVID-19) pandemic. Most countries throughout the world have rolled out extensive vaccination programs to vaccinate and protect individuals from severe infections and deaths associated with COVID-19. However, the US Centers for Disease Control and Prevention (CDC) reported mild to moderate myocarditis/pericarditis cases post the second dose of mRNA vaccination on 17th May 2021. Most of the patients who were found less than 50 years of age were reported to be presented with chest pain, fever, raised cardiac-specific troponin many days after vaccination followed by full recovery.
10th Mar 2022 - News-Medical.Net

Vaccines and Omicron mean Covid now less deadly than flu in England

A combination of high levels of immunity and the reduced severity of the Omicron variant has rendered Covid-19 less lethal than influenza for the vast majority of people in England, according to a Financial Times analysis of official data. But the speed with which Omicron infects people still pushed the total number of deaths this winter whose underlying cause was a main respiratory disease to 9,641 since the first week of January, 50 per cent higher than in a typical flu season despite lower levels of social mixing, the Office for National Statistics figures revealed.
10th Mar 2022 - Financial Times

Pfizer launches clinical trial testing its COVID-19 pill in children aged 6 and older

Pfizer announced Wednesday it is launching a clinical trial to study the effectiveness of its COVID-19 antiviral pill in young children. The treatment, Paxlovid, was authorized in December 2020 by the U.S. Food and Drug Administration for emergency use in patients aged 12 and older who have mild-to-moderate symptoms and are at increased risk of severe illness.
10th Mar 2022 - ABC News

Masking In K-12 Schools Significantly Reduces Covid-19 Among Staff And Students

The US is breathing a collective sigh of relief as the Covid-19 Omicron wave has largely subsided. The latest CDC data show most of the country to be experiencing either “low” (green) or “medium” (yellow) levels of transmission — levels at which CDC’s new recommendations don’t require most people to wear face masks most of the time. Even though I am hopeful that we are witnessing Covid-19’s final denouement, it is important to remain vigilant about the possibility of future waves of transmission. If another high transmission variant does appear, we should remember that the protective benefits of wearing face masks are now well documented. A new study from Arkansas adds to this evidence. The new data enabled epidemiologists to measure the effectiveness of mask requirements in K-12 schools during the Delta wave of Covid-19 from August to October, 2021.
10th Mar 2022 - Forbes

Covid treatment sotrovimab can cause drug-resistant mutation, study finds

S.Africa's Aspen to supply its own branded COVID-19 vaccine by June

South Africa's Aspen Pharmacare will start supplying its branded COVID-19 vaccine to African nations by June, its chief executive told Reuters on Wednesday, after the drugmaker reported a 37% rise in profit for the half-year to Dec. 31. Its shares were up 5% by 1315 GMT, outpacing a 0.6% rise in the broader market index. Aspen said on Tuesday it had struck a deal with Johnson & Johnson to package, sell and distribute the American group's COVID vaccines under the Aspenovax brand in Africa. The agreement paves the way for Aspen to supply the COVID-19 vaccine across Africa, which has by far the lowest vaccination rate in the world.
10th Mar 2022 - Reuters.com

Variant that combines Delta and Omicron identified; dogs sniff out virus with high accuracy

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. "Deltacron" with genes of Delta and Omicron found Hybrid versions of the coronavirus that combine genes from the Delta and Omicron variants - dubbed "Deltacron" - have been identified in at least 17 patients in the United States and Europe, researchers said. Because there have been so few confirmed cases, it is too soon to know whether Deltacron infections will be very transmissible or cause severe disease, said Philippe Colson of IHU Mediterranee Infection in Marseille, France, lead author of a report posted on Tuesday on medRxiv ahead of peer review.
10th Mar 2022 - Reuters

Africa CDC has MOU with Pfizer for supplies of COVID-19 pill

Africa's top public health agency has agreed a memorandum of understanding with Pfizer to bring supplies of the pharmaceutical firm's Paxlovid antiviral COVID-19 pills to the continent, its director said on Thursday. Data from a mid-to-late stage study in November showed Paxlovid was nearly 90% effective in preventing hospitalisations and deaths compared to placebo, in adults at high risk of severe illness. John Nkengasong, head of the Africa Centres for Disease Control and Prevention (CDC), also said it was still talking to Merck about obtaining supplies of its molnupiravir COVID pill and a call was scheduled for this week about that.
10th Mar 2022 - Reuters

Novavax, eyeing the COVID 'vaccine hesitant' and kids, unveils new education campaigns as Nuvaxovid nears US finish line

Pfizer, Moderna and Johnson & Johnson were quickest off the mark in getting COVID vaccines into American arms, but Novavax is hoping to add another pandemic vaccine to the U.S. mix soon—and it's pushing new campaigns to get the word out. The biopharma, which has approvals and authorizations in Europe and around the world, is now on the cusp of a potential green light in the U.S. And with a market comes the need for marketing. But because it still has no U.S. approval—and it cannot under law advertise to consumers in Europe—Novavax is launching two new global, unbranded vaccine education programs: "We Do Vaccines" and "Know Our Vax." They're designed to offer up vaccine information and "explain Novavax’ commitment to vaccine development and innovation,” the company told Fierce Pharma Marketing.
10th Mar 2022 - Fiercepharm

Ukraine Covid Pill Development Project Disrupted by Russian Invasion

The night before Russia invaded Ukraine, chemist Tetiana Matviyuk worked late into the night at her Kyiv office. By 10:30 p.m., she had wrapped up after a Zoom meeting with a global team of scientists working on a new, experimental Covid-19 treatment. The day before, she had shipped crucial compounds to colleagues in the U.K. Her team was closing in on the project’s finish line and their moment of Champagne celebration. But instead of euphoria, Matviyuk was filled with dread. She called her husband on her drive home. “I said, ‘I’m feeling that something bad can happen,’” says Matviyuk, 35, principal scientist in medicinal chemistry and computer drug design at contract research group Enamine Ltd. “He was just laughing at me, that I’m crazy and too nervous, and keep calm, everything will be fine.”
10th Mar 2022 - Bloomberg

Mental decline seen in older COVID patients 1 year later

Cognitive impairment was more common among COVID-19 patients 60 years and older—particularly those with severe illness—released from hospitals in Wuhan, China, than among their uninfected peers, according to a 1-year follow-up study yesterday in JAMA Neurology. A team led by researchers at Daping Hospital in Chongqing, China, followed 1,438 COVID-19 survivors aged 60 and older released from one of three dedicated COVID-19 hospitals in Wuhan from Feb 10 to Apr 10, 2020, and compared them with 438 of their uninfected spouses. Because pre-COVID cognitive status wasn't available, family members provided their perceptions of cognitive changes using the Chinese version of the short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE).
9th Mar 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Mar 2022

View this newsletter in full

WHO lays out plan for COVID vaccines to tackle new variants

The World Health Organization (WHO) technical advisory group on COVID-19 vaccines today weighed in on potential updates to COVID-19 vaccines in light of emerging variants such as Omicron, outlining different options and what data are needed to guide new strategies. In other developments, countries experiencing later Omicron surges—especially in Asia—continue to report cases at or near record daily highs. And, in the United States, weekly pediatric COVID-19 cases dropped below 100,000, part of a 6-week decline from the Omicron peak in children.
9th Mar 2022 - CIDRAP

'Variant-proof' Covid vaccine created in UK

A British “variant-proof” vaccine has received tens of millions of pounds of funding in the hope it may provide more durable protection against Sars-Cov2 — and against coronaviruses that don’t even exist yet. Boris Johnson hailed the technology as part of the “next generation of vaccines” as he opened a conference in London held by the Coalition for Epidemic Preparedness Innovations.
9th Mar 2022 - The Times

Altamira Therapeutics Receives Approval to Commence Clinical Trial Evaluating Bentrio in the Treatment of COVID-19

Altamira Therapeutics Ltd. a company dedicated to developing therapeutics that address important unmet medical needs, today announced that its affiliate, Altamira Medica, has received the necessary approvals to initiate a clinical investigation of Bentrio™ in COVID-19 patients (the “COVAMID” study). COVAMID is a randomized, placebo controlled clinical trial to evaluate the ability of Bentrio™ nasal spray to reduce the SARS-CoV-2 viral load in the nose, alleviate COVID-19 signs and symptoms, and decrease the frequency of COVID-19 related hospital admissions.
9th Mar 2022 - The Associated Press

Pfizer Starts Testing Its Covid-19 Pill in Children

Pfizer Inc. has begun studying its Covid-19 pill in children under 18 years old who are at high risk of developing severe disease. The study will evaluate whether the five-day treatment Paxlovid, which is in use among people 12 years and older, can also keep children who are newly infected by the coronavirus out of the hospital, Pfizer said Wednesday. The first child enrolled in the study on Monday. Pfizer expects results by the end of the year, said Annaliesa Anderson, who leads the company’s Paxlovid research. Should results from the pediatric study prove positive, the antiviral would be the first Covid-19 pill for children under 12 years and an especially important remedy for those with underlying health conditions who cannot be vaccinated or whose parents don’t want them to get shots.
9th Mar 2022 - The Wall Street Journal

Janssen and Aspen enter deal to manufacture Covid-19 vaccine in Africa

Janssen Pharmaceuticals of Johnson & Johnson (J&J) has concluded an agreement with South Africa based company Aspen to manufacture and distribute Covid-19 vaccines in Africa. The companies intend to boost Covid-19 inoculation rates in Africa through this alliance. Under the deal, J&J will provide Covid-19 vaccine drug substance to Aspen, which will manufacture and make the finished vaccines available under its own brand name Aspenovax. The vaccines will be provided to all 55 Member States of the African Union (AU), as well as crucial multilateral entities that back the Covid-19 inoculation campaign in Africa, including the African Vaccine Acquisition Trust (AVAT) and the COVAX Facility.
9th Mar 2022 - Pharmaceutical Technology

Having Covid-19 linked to risk of economic hardship, study suggests

People living in the UK’s most deprived areas are more likely to be infected with Covid-19, but research suggests this relationship is a two-way street: becoming infected also increases people’s risk of economic hardship, particularly if they develop long Covid. “We’ve shown that Covid has an impact on people’s ability to meet their basic household requirements – something that is only going to be exacerbated by the cost of living crisis which is happening at the same time,” said Adrian Martineau, a professor of respiratory infection and immunity at Queen Mary University of London (QMUL), who supervised the research. The findings have boosted calls for ministers to do more to support the growing number of working-age adults affected by the condition, which is also known as post-acute Covid syndrome (Pacs).
9th Mar 2022 - The Guardian

South Africa's Aspen signs deal to package and sell J&J COVID vaccine

South African drugmaker Aspen Pharmacare concluded an agreement with Johnson & Johnson to package, sell and distribute the American group's COVID-19 vaccines under its own brand in Africa. In November Aspen entered into talks with J&J for a licensing deal that would give it freedom to sell and distribute the vaccine under its own brand. The agreement also allows Aspen to "discuss the expansion of the agreement to include any new versions of the drug substance, such as those developed for new variants or a different formulation for administration as a booster", Aspen said in a statement.
9th Mar 2022 - Reuters

Pfizer begins COVID pill study in high-risk children aged 6-17

Pfizer said on Wednesday it has begun a mid-to-late-stage study of its antiviral COVID-19 pill for non-hospitalized children aged 6-17 years who are at high risk of developing severe illness. Pfizer's Paxlovid pill is authorized for emergency use in the United States for kids 12 years or older and high-risk adults. But there are no oral antiviral treatments for COVID-19 authorized in the United States for younger children. The drugmaker plans to enroll 140 children in the study across two groups of 6- to 17-year-olds, with one group including those at least 40 kilograms in weight and the other weighing between 20 kgs and 40 kgs.
9th Mar 2022 - Reuters

Study reveals some brain changes, even in mild COVID-19

Adult COVID-19 survivors—even those with mild illness—who underwent scans showed changes in brain structure beyond that expected from normal aging, including in areas tied to smell and memory, according to a UK study published yesterday in Nature. University of Oxford investigators administered cognitive tests to and scanned the brains of 785 visitors to the UK Biobank imaging centers two times an average of 38 months apart. Of the 785 participants, 401 (51%) were diagnosed as having COVID-19 between their scans, from March 2020 to April 2021. The remaining 384 participants were age- and sex-matched controls. Patients were aged 51 to 81 years.
8th Mar 2022 - CIDRAP

Most mRNA COVID vaccine adverse events mild, transient

The vast majority of adverse events (92%) recorded after people received the Pfizer/BioNTech or Moderna mRNA COVID-19 vaccines during the first 6 months of the US vaccine rollout were mild and transient, according to an observational study published yesterday in The Lancet Infectious Diseases.
8th Mar 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Mar 2022

View this newsletter in full

Moderna looks to enforce its Covid-19 vaccine patents in wealthy countries

Amid intense public pressure, Moderna (MRNA) updated a pledge never to enforce patents for its Covid-19 vaccines against manufacturers that supply dozens of low- and middle-income countries as part of a World Health Organization program. But at the same time, the vaccine maker indicated it would enforce its patents in wealthier nations. In an announcement issued late Monday, the company maintained that supplies beyond the 92 countries covered by the WHO’s COVAX program are “no longer a barrier to access” and, as a result, licenses will be offered to manufacturers for its technology on “commercially reasonable terms.” There was no detail about the technologies that would be covered or timing to enforce its patents.
8th Mar 2022 - STAT News

The U.S. is about to approve a fourth COVID vaccine that could be a silver bullet solution to the anti-vax crisis

It might not be long until a fourth COVID vaccine is available in the U.S., and it’s a big deal. Novavax Inc.’s COVID-19 vaccine is on its way towards authorization from the U.S. Food & Drug Administration after formally submitting a request in late January. The company says it has resolved the manufacturing issues that had delayed their application, and now expects approval from the FDA in the coming weeks, according to reporting from the Wall Street Journal. In clinical trials first published in January 2021, Novavax’s vaccine was up to 90% effective in preventing severe COVID-19 infections, on par with the already-approved vaccines from Pfizer and Moderna. But questions remained about the company’s manufacturing capabilities that have delayed its ability to bring the vaccine to market. The Maryland-based biotech firm has already won approval for its vaccine in Australia, India, the European Commission and several other countries since last November.
8th Mar 2022 - Fortune

French study shows COVID vaccine efficacy 94% against severe outcomes

In late December 2019, France began administering vaccinations against coronavirus disease 2019 (COVID-19) to its population. At the end of 2021, 77% of the entire population were fully vaccinated, and 91% of those 18 years or older. During these times, France experienced three epidemic waves caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants Alpha, Delta, and Omicron. Vaccination administration was stratified among the different population groups due to limited availability, begging with those at most risk of severe COVID-19-related complications and those who work in healthcare. Moderna, Pfizer/BioNTech, AstraZeneca, and Janssen were the four Covid-19 vaccine brands utilized. With the exception of the Janssen vaccine, which only required one dosage, a vaccination program was initially considered complete following two doses. A complete vaccination cycle had become a prerequisite for obtaining a French health permit, which became effective in June and was first necessary to enter events and places with large crowds. In August, the health pass was expanded to include admission to all museums, bars, restaurants, railways, and other public venues.
8th Mar 2022 - News-Medical.Net

Who's at the greatest risk of being hospitalized by COVID-19? New Public Health data breaks it down

New data from Newfoundland and Labrador's Department of Health highlights who is at the greatest risk of severe health outcomes due to COVID-19 as the province aims to lift all public health restrictions later this month. According to the data provided to CBC News last week, 138 people were admitted to hospital due to COVID-19 from Dec. 15, deemed the beginning of the province's Omicron wave, to Feb. 28. For comparison, Newfoundland and Labrador reported more than 24,000 cases of the virus in that period but the actual number is much higher, as not all positive cases in the province were reported to public health. The data is broken down into two categories: age and vaccination status. Sixty-seven of the 138 hospitalizations, or about 49 per cent, were people over the age of 70. Additionally, 23 people were in their 60s, 26 were in their 50s, six were in their 40s, four were between the ages of 20 and 39 and 12 people were under the age of 20.
8th Mar 2022 - CBC.ca

COVID-19 associated with "significant, deleterious impact" on brain, finds U.K. study

Scans and cognition tests collected from hundreds of people suggest coronavirus infection is associated with "a significant, deleterious" change in the brain, according to a study published Monday from scientists in the United Kingdom. The paper, published in the journal Nature, draws on data in the U.K. Biobank from 401 people between the ages of 51 and 81 who had COVID-19 through April 2021. Researchers analyzed data from brain scans and tests collected from participants both before they were infected with the disease, and from a second round conducted later, close to five months on average after they tested positive.
8th Mar 2022 - CBS News

Moderna to share vaccine tech, commits to never enforce COVID-19 jab patents

Moderna has pledged never to enforce its coronavirus vaccine patents in selected low- and middle-income countries and is launching a new initiative to give external researchers access to its technology. The announcement comes amid increasing pressure on the U.S. biotech firm, which pulled in more than $12 billion in 2021, to share its technology with initiatives aimed at increasing vaccine manufacturing capacity in low- and middle-income countries. “It’s a very big announcement,” CEO Stéphane Bancel told POLITICO in an interview. Bancel was visibly excited when he explained that for years his team been working on various infectious diseases but as a small company they had been limited in what they could do. The runaway success of their mRNA coronavirus vaccine has opened new doors. “We want to make sure that we have all the tools to provide the world with a much better response, if God forbid something happens again,” said Bancel.
8th Mar 2022 - POLITICO Europe

COVID-19: New study could lead to life-saving treatment for severe cases

The world's largest genetic study of people with severe COVID has identified DNA variations that could lead to new life-saving treatments for the disease. The research identified 16 changes to the DNA sequence of critically ill COVID patients that affected their immune response, or increased the risk of blood clotting and inflammation in the lungs. The researchers in the GenOMICC consortium, which involved almost every intensive care unit in the UK, say the findings map out new molecular targets for drugs that are currently used to treat other medical conditions. Professor Kenneth Baillie, the study's chief investigator and a critical care consultant at the University of Edinburgh, said: "We have shown for the first time in the history of critical care medicine that an infectious disease that causes organ failure is treatable by supressing the immune system.
8th Mar 2022 - Sky News

COVID-19 can cause brain shrinkage: study

A new study by Oxford University has found COVID-19 can cause the brain to shrink, reduce grey matter in the regions that control emotion and memory, and damage areas that control the sense of smell.
8th Mar 2022 - Reuters

Moderna plots vaccines against 15 pathogens with future pandemic potential

Moderna Inc said on Monday it plans to develop and begin testing vaccines targeting 15 of the world's most worrisome pathogens by 2025 and will permanently wave its COVID-19 vaccine patents for shots intended for certain low- and middle-income countries. The U.S. biotechnology company also said it will make its messenger RNA (mRNA) technology available to researchers working on new vaccines for emerging and neglected diseases through a program called mRNA Access. Moderna announced its strategy ahead of the Global Pandemic Preparedness Summit sponsored by the UK government and the Coalition for Epidemic Preparedness Innovations (CEPI), an international coalition set up five years ago to prepare for future disease threats.
8th Mar 2022 - Reuters

Omicron infections contagious for at least 6 days; Takeda drug shows promise as COVID treatment

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Omicron infections are contagious for at least 6 days Patients infected with the Omicron variant of SARS-CoV-2 remain contagious for just as long as patients infected with earlier variants, according to a small study. Researchers took blood samples from 56 newly-diagnosed patients, including 37 with Delta infections and 19 with Omicron infections. All were mildly ill, such as with flu-like symptoms, but none were hospitalized
8th Mar 2022 - Reuters

Scientists identify new gene differences in severe COVID patients

Scientists have pinpointed 16 new genetic variants in people who developed severe COVID-19 in a large study published on Monday that could help researchers develop treatments for very sick patients. The results suggest that people with severe COVID have genes that predispose them to one of two problems: failure to limit the ability of the virus to make copies of itself, or excessive inflammation and blood clotting. The scientists said their discoveries, published in the journal Nature, could help prioritise the likely treatments that could work against the disease. Eventually, the information could even help predict which patients were likely to become severely ill.
8th Mar 2022 - Reuters

Covid Can Shrink the Brain as Much as a Decade of Aging, Study Finds

Even a mild case of Covid-19 can damage the brain and addle thinking, scientists found in a study that highlights the illness’s alarming impact on mental function. Researchers identified Covid-associated brain damage months after infection, including in the region linked to smell, and shrinkage in size equivalent to as much as a decade of normal aging. The changes were linked to cognitive decline in the study, which was published Monday in the journal Nature. The findings represent striking evidence of the virus’s impact on the central nervous system. More research will be required to understand whether the evidence from the Wellcome Centre for Integrative Neuroimaging at the University of Oxford means Covid-19 will exacerbate the global burden of dementia -- which cost an estimated $1.3 trillion in the year the pandemic began -- and other neurodegenerative conditions.
8th Mar 2022 - Bloomberg

Health groups press for more wildlife SARS-CoV-2 tracking

The statement on animal surveillance came from the United Nations Food and Agriculture Organization (FAO), the World Organisation for Animal Health (OIE), and the World Health Organization (WHO). They said though wildlife doesn't play a key transmission role in humans, SARS-CoV-2 spread in animal populations can affect their health and lead to the emergence of new variants. So far, farmed mink and pet hamsters have shown the capacity to infect humans, and scientists are reviewing a possible case of transmission between white-tailed deer and a human. And in the United States, large numbers of white-tail deer have been shown to carry the virus, underscoring concerns about establishment of an animal reservoir.
8th Mar 2022 - CIDRAP

COVID deaths vary by race, community, social factors

Social determinants of health (SDOH) tied to COVID-19 death rates varied by race and community type in the first year of the pandemic, suggests an observational spatial analysis involving 3,142 counties in all 50 US states and Washington, DC. The study was published late last week in JAMA Network Open. SDOH are nonmedical factors, such as where people live and work, that influence health outcomes such as COVID-19 infection and death. "Racial disparities in health largely emanate from the inequitable access to social, economic, and physical or built environmental conditions resulting from racism in the US," the researchers wrote. "Specifically, racism interacts with and exists within societal structures and systems to shape the major SDOH."
7th Mar 2022 - CIDRAP

Less than 500 COVID-19 patients in serious condition

A total of 4,769 new COVID-19 cases were diagnosed across Israel on Monday, Israel's Health Ministry reported Tuesday morning. The new cases bring the countrywide total to 48,408 active cases, among them 969 hospitalized patients.
8th Mar 2022 - Arutz Sheva

Less than 500 COVID-19 patients in serious condition

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Mar 2022

View this newsletter in full

Omicron infections contagious for at least 6 days; Takeda drug shows promise as COVID treatment

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Omicron infections are contagious for at least 6 days Patients infected with the Omicron variant of SARS-CoV-2 remain contagious for just as long as patients infected with earlier variants, according to a small study. Researchers took blood samples from 56 newly-diagnosed patients, including 37 with Delta infections and 19 with Omicron infections. All were mildly ill, such as with flu-like symptoms, but none were hospitalized. Regardless of which variant or whether or not they had been vaccinated or boosted, study participants "shed live virus for, on average, about 6 days after symptoms (began), and... about one in four people shed live virus for over 8 days," said Dr. Amy Barczak of the Massachusetts General Hospital in Boston, who coauthored a report posted on medRxiv ahead of peer review.
8th Mar 2022 - Reuters

Scans reveal how Covid may change the brain

Catching Covid may cause changes to the brain, a study suggests. Scientists found significant differences in MRI (magnetic resonance imaging) scans before and after infection. Even after a mild infection, the overall size of the brain had shrunk slightly, with less grey matter in the parts related to smell and memory. The researchers do not know whether the changes are permanent but stressed the brain could heal. The study is published in the journal Nature.
7th Mar 2022 - BBC News

Behind the scenes of the Pfizer COVID-19 vaccine

At the New York labs of pharmaceutical giant Pfizer, chairman and CEO Dr. Albert Bourla showed correspondent Alina Cho where scientists are working on the next generation of COVID vaccines, testing vaccinated and unvaccinated cell samples against new variants. These are the same labs where they helped pioneer the original vaccine. Think back to two years ago, as COVID-19 spread across the world, when the normal timeline for the development of a vaccine was eight to ten years. "You went to your team and you said, 'Get one in eight months,'" said Cho. "Did you honestly believe you could get it done?" "I felt that we don't have option to fail," Bourla replied.
7th Mar 2022 - CBS News

Omicron doesn't need its own custom COVID vaccine: here's why

The Omicron variant of the SARS-CoV-2 virus was discovered in South Africa and emerged in November 2021. Scientists have already learned a lot about Omicron. One of the key questions that remains is how well our immune systems deal with infection by this variant. This is important for two reasons. Firstly, Omicron is highly infectious and has swept across the world. Thus, many people have been exposed to Omicron and we need to define how well such people are protected from future re-infections by emerging variants. Secondly, several vaccine manufacturers have started to incorporate Omicron into their vaccines.
7th Mar 2022 - The Conversation

Moderna reaches preliminary agreement to build Covid vaccine manufacturing plant in Africa

Moderna plans to invest $500 million to produce messenger RNA, the technology underlying its Covid vaccines, at the facility in Kenya. It could fill Covid vaccine doses at the Kenya facility as early as 2023 subject to demand, according to the company. Moderna has faced criticism from groups such as Oxfam International and Doctors Without Borders for not sharing its vaccine technology with middle and lower income countries.
7th Mar 2022 - CNBC

Why have some people never caught Covid? The answers could help protect us all

I’m one of the fortunate people who is yet to test positive for Covid. This is despite the fact that I work with live replicating Sars-CoV-2 (the virus that causes Covid) for my research, teach face-to-face at university, and have school-age children. My fully vaccinated healthy friends of the same age were not so lucky, and some have suffered from more than one case of Covid in the past couple of years. What does this reveal about my immune system? First, we have to consider a number of scenarios. There is a very small chance that I have never come into contact with the virus. But given the duration of the pandemic, and the number of highly transmissible variants, this is unlikely. Then there is the chance that I have come into contact with Sars-CoV-2, but it was cleared from my body quickly before it developed into the disease Covid (abortive infection). At the start of the pandemic, and before I was vaccinated, I could have caught the virus but I could have been one of the small number of people who did not display symptoms and therefore did not test for it.
7th Mar 2022 - The Guardian

Myocarditis and pericarditis in COVID-19 vaccine recipients

Are the cardiac complications associated with the coronavirus disease 2019 (COVID-19) vaccines worse than the disease itself? In order to answer this question, it is necessary to understand their true incidence and association with the vaccine. A new study published on the preprint server medRxiv* provides valuable evidence towards this end, using surveillance data to provide the best estimates of these outcomes. The onset of COVID-19, caused by infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), led to a worldwide outbreak of infections, sickness, and death. The emergence and rapid transmission of SARS-CoV-2 prompted the development of vaccines to potentially create herd immunity and limit the spread of SARS-CoV-2. However, doubts raised by the unprecedented speed of vaccine approval, the novel platforms used for their development, and the rapid spread of conspiracy theories, accompanied by a severe shortfall of vaccine supplies to developing areas of the world, hindered the expected speed of vaccine coverage. During this lag period, attention shifted to the potential adverse effects associated with COVID-19 vaccines.
7th Mar 2022 - News-Medical.Net

COVID-19 vaccine rollout worsened existing health inequalities, study finds

The wide inequalities in COVID-19 vaccine uptake between people from ethnic minority groups and White British people are far greater than for the pre-pandemic flu jab, a study by University of Manchester health researchers has found. The findings, published in PLOS Medicine, overturns the prevailing view that ethnic inequalities in COVID-19 vaccine uptake simply follow previous trends in people's willingness to take up vaccination. Instead, the researchers suggest, the COVID-19 vaccination program has created additional and different inequalities beyond pre-existing inequalities in vaccine uptake.
7th Mar 2022 - Medical Xpress

Greater Boston COVID recovery cohort joins national effort to study long-term effects of COVID-19

A consortium of six sites in the Boston area led by Mass General Brigham’s Brigham and Women’s Hospital will together recruit participants as part of a nationwide study of the long-term effects and prolonged symptoms of COVID-19. Together, the sites will recruit 909 participants over the next year to be part of the greater Boston COVID Recovery Cohort (BCRC). Participants will be followed for the next three years. As part of the National Institutes of Health “Researching COVID to Enhance Recovery” (RECOVER) Initiative, the cohort will help researchers to better understand and define the constellation of long-term complications that can occur after infection and lay the groundwork for preventing and treating symptoms. The six Boston area sites include Beth Israel Deaconess Medical Center, Boston Medical Center, Cambridge Health Alliance, Tufts Medical Center and Mass General Brigham founding hospitals Brigham and Women’s Hospital and Massachusetts General Hospital.
7th Mar 2022 - EurekAlert!

Severity of COVID-19 cases in the months of Alpha variant predominance compared to the Delta variant

The findings of the study demonstrated the higher occurrence of more severe cases during the predominance of the Alpha variant as compared to the Delta wave after adjusting the regression model for effects like age and status of vaccination.
7th Mar 2022 - News Medical

Oxford COVID-19 Vaccine Effective in Protecting Socially Vulnerable Populations

The Oxford-AstraZeneca vaccine is also effective in reducing symptomatic COVID-19 in a socially vulnerable community, where viral transmission is high and access to healthcare might be limited. This is the conclusion of a study performed in a group of favelas in Brazil, and co-led by ISGlobal, a centre supported by the ”la Caixa” Foundation, and the Oswaldo Cruz Foundation in Brazil (Fiocruz). A large number of people in low- and middle-income countries live in densely populated slums or favelas, often with limited resources to respond to the stress caused by a pandemic such as COVID-19. “We know that socially vulnerable populations have been disproportionately affected by the COVID-19 pandemic – they are more exposed to the virus and are more likely to die if they get sick” says ISGlobal researcher Otavio Ranzani, “but studies estimating vaccine effectiveness in these populations are lacking,” he adds. Moreover, few studies have assessed vaccine effectiveness against the Gamma variant, which circulated mainly in Brazil and Latin America, and is able to partially escape recognition by vaccine-induced antibodies.
7th Mar 2022 - Technology Networks

Exploring the ethics of genetic prioritisation for COVID-19 vaccines

There is evidence to suggest that host genomic factors may account for disease response variability in COVID-19 infection. In this paper, we consider if and how host genomics should influence decisions about vaccine allocation. Three potential host genetic factors are explored: vulnerability to infection, resistance to infection, and increased infectivity. We argue for the prioritisation of the genetically vulnerable in vaccination schemes, and evaluate the potential for ethical de-prioritisation of individuals with genetic markers for resistance. Lastly, we discuss ethical prioritisation of individuals with genetic markers for increased infectivity (those more likely to spread COVID-19).
7th Mar 2022 - Nature

SII receives EUA grant recommendation from SEC for Covid-19 vaccine

Serum Institute of India (SII) has received an emergency use authorisation (EUA) grant recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) for its Covid-19 vaccine, Covovax, for people aged 12 to 17 years. The recommendation comes after the panel held a meeting for Covid-19 associated proposals, ANI reported. The vaccine is produced by the transfer of technology from Novavax.
7th Mar 2022 - Pharmaceutical Technology

Moderna taps Kenya as site for $500M mRNA manufacturing facility

Moderna tapped Kenya as the country for its $500 million mRNA vaccine manufacturing push on the African continent. The drugmaker said it inked a memorandum of understanding with Kenyan officials to build a state-of-the-art mRNA facility, which was first announced in October 2021. The site will focus on producing up to 500 million vaccine doses a year. The company said the plant will benefit all of Africa and in the future could be expanded to include fill-finish and packaging capabilities at the site. Additionally, Moderna said it is working toward getting the plant built and operational to fill doses of its COVID-19 vaccines in Africa by 2023 depending on demand for the shots. The exact location and square footage of the proposed manufacturing plant within Kenya weren’t disclosed.
7th Mar 2022 - FiercePharma

‘We’re all in this together’: As long Covid studies continue, researchers cast a wider net

There are almost as many questions about long Covid as there are symptoms. From the pandemic’s early days, a significant share of people have been troubled by problems that persist for weeks or even years after their acute infection clears, or find they’ve developed new issues that range from bothersome to debilitating. These difficulties span the mind and the body, and so far they resist explanation. Current treatments focus on easing brain fog, bone-wearying fatigue, shortness of breath, muscle pain, loss of smell, anxiety and depression, and sleep problems, but two burning questions remain unanswered: Who gets long Covid and how can it be prevented?
7th Mar 2022 - STAT News

COVID-only Minnesota hospitals had lower death rates

A Minnesota health system that established two COVID-19 patient-only hospitals early in the pandemic had lower rates of coronavirus-related death than hospitals with mixed patient cohorts, according to a study published yesterday in JAMA Network Open. University of Minnesota at Minneapolis researchers studied the outcomes of 5,504 adult COVID-19 patients treated at M Health Fairview from Mar 1, 2020, to Jun 30, 2021, from 11 hospitals, including 2 reserved for the treatment of COVID-19 patients. Median patient age in the entire cohort was 62.5 years, and 51.9% were women. Of the 5,504 patients, 2,077 (37.7%) were treated at one of the two dedicated hospitals in St. Paul, and 3,427 (62.3%) were cared for at the other hospitals.
4th Mar 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Mar 2022

View this newsletter in full

Novavax’s Covid-19 Vaccine Moves Closer to FDA Authorization Decision

Novavax’s long-awaited Covid-19 vaccine is moving toward U.S. authorization after the company said it resolved manufacturing problems that had held up its application. Clearance in the U.S. isn’t imminent because the Food and Drug Administration must sort through a large amount of study data from several countries. A decision is getting closer, however, since Novavax formally submitted an authorization request in late January. If the shot is rolled out in the U.S., it could boost vaccination efforts that have flagged among the hesitant, according to Novavax and doctors.
6th Mar 2022 - The Wall Street Journal

Shionogi Says Covid-19 Vaccine Found Effective and Safe in Study

Japanese drugmaker Shionogi & Co. said its experimental Covid-19 vaccine was found safe and effective in a study, creating an indigenous supply source for the Asian nation that is racing to complete a booster drive in hopes of curbing future outbreaks. The recombinant protein-based vaccine that was being tested as a booster shot met its primary endpoint in the Phase 2/3 trials, Osaka-based Shionogi said in a statement Friday announcing the interim report’s findings. There were no serious treatment-related adverse events, deaths or adverse events of special interest, it said.
5th Mar 2022 - Bloomberg

These Covid-19 symptoms raise new questions

Two years ago, the calamitous first wave of the Covid-19 pandemic hit the US with unprecedented intensity. The depth of the terror can be difficult to recall and, thanks to advances in diagnosis, treatment and vaccination, is unlikely to recur. For scientists, however, it is crucial to revisit the dark time and rethink what happened by examining the almost endless data that was collected to try to better understand both the immediate and the long-term effects this disease has on the body. Because so many deaths were due to respiratory failure, many colleagues I talked with expected to find progressive pneumonia with lung destruction as the cause. However, researchers discovered something entirely different: blood clots in the lungs (also referred to as pulmonary emboli). Furthermore, they found countless additional smaller clots in many other organs as well. (Note that experts distinguish between clot and thrombus and embolus but for simplicity, we'll call them all clots.)
5th Mar 2022 - CNN

Coronavirus Update: What does the end of COVID-19 rules mean for transmission?

In the past seven days, 39,946 cases were reported, down 4 per cent from the previous seven days. There were 449 deaths announced, down 4 per cent over the same period. At least 4,454 people are being treated in hospitals. Canada’s inoculation rate is 13th among countries with a population of one million or more people.
5th Mar 2022 - The Globe and Mail

Imported Covid-19 cases in Shenzhen soar to 96, all from Hong Kong

The southern province of Guangdong reported China’s highest number of daily imported Covid-19 cases, accounting for nearly half of the nationwide tally and with all but two cases originating from neighbouring Hong Kong. Of 233 imported cases declared by Chinese health authorities on Friday, as many as 117 were detected in Guangdong, mostly in the tech hub of Shenzhen just across the border from Hong Kong, which is battling an exponential fifth wave of the coronavirus pandemic. Shenzhen detected 96 infections on Thursday, all of them from Hong Kong. Other Guangdong cities reporting cases from Hong Kong were Zhuhai with six, four each in Zhongshan and Jiangmen, two each in Huizhou and Shanwei, and one in Foshan.
5th Mar 2022 - South China Morning Post

One-stop shot – the scientists developing a ‘universal’ coronavirus vaccine

Researchers are hopeful that a variant-proof vaccine is within their grasp - to protect us from this pandemic and to prevent the next one. Imagine if a single vaccine could protect us against not only new variants of the current coronavirus, Covid-19, but also against coronaviruses that do not yet exist. Buoyed by the creation of several working vaccines against Covid in under a year, scientists now have a “universal vaccine” in their sights. In January, senior US scientists including chief medical advisor Anthony Fauci, called for more research into a universal coronavirus vaccine. The Coalition for Epidemic Preparedness Innovations (CEPI), a global organisation created to develop vaccines against future pandemics, has earmarked $200 million for a vaccine to protect against variants of the current virus, SARS-CoV-2, and any coronaviruses that may plausibly emerge in the future.
5th Mar 2022 - Evening Standard

Covid Invades Cells in the Penis and Testicles of Monkeys, Study Says

The coronavirus may infect tissue within the male genital tract, new research on rhesus macaques shows. The finding suggests that symptoms like erectile dysfunction reported by some Covid patients may be caused directly by the virus, not by inflammation or fever that often accompany the disease. The research demonstrated that the coronavirus infected the prostate, penis, testicles and surrounding blood vessels in three male rhesus macaques. The monkeys were examined with whole body scans specially designed to detect sites of infection. Scientists — who expected to find the coronavirus in spots like the lungs but did not know where else they would find it — were somewhat surprised by the discovery.
5th Mar 2022 - The New York Times

Covid-19 update: Omicron strain 40% more lethal than flu

The global Covid death toll has passed 5.9 million, with a figure of 5,972,661 according to researchers at Johns Hopkins University. Meanwhile, infections have continued past 440 million to a world wide figure of 440,182,504. The Omicron strain of Covid-19 is at least 40% more lethal than seasonal flu, according Japanese scientists, underscoring the potential danger of lifting pandemic curbs too quickly and underestimating the virus’s ongoing health risks. Rates of anxiety and depression rose by about 25% worldwide in the first year of Covid, another indication of the widespread harm on mental health inflicted by the pandemic. Young people were at the greatest increased risk of suicide and self-harm, and women bore the brunt of the emotional and psychological burden, according to a report from the World Health Organization
4th Mar 2022 - Pharmaceutical Technology

Why are vaccination rates still low in some countries?

Why are COVID-19 vaccination rates still low in some countries? Limited supplies remain a problem, but experts say other challenges now include unpredictable deliveries, weak health care systems and vaccine hesitancy. Most countries with low vaccination rates are in Africa. As of late February, 13 countries in Africa have fully vaccinated less than 5% of their populations, according to Phionah Atuhebwe, an officer for the World Health Organization’s regional office for Africa. Other countries with extremely low vaccination rates include Yemen, Syria, Haiti and Papua New Guinea. For most of last year, developing nations were plagued by a lack of supplies. Rich countries were hoarding doses and many countries didn’t have the facilities to make their own vaccines. COVAX — an initiative to distribute vaccines equally around the world — faltered in delivering shots.
3rd Mar 2022 - The Associated Press

Arthritis drug could help save Covid patients – study

A drug used to treat rheumatoid arthritis could help to save the lives of patients with severe Covid, researchers have found, and they say its benefits can be seen even when it is used on top of other medications. Experts involved in the Randomised Evaluation of Covid-19 Therapy (Recovery) trial say baricitinib, an anti-inflammatory drug taken as a tablet, can reduce the risk of death from severe Covid by about a fifth. However, they add that when the impact of other medications used alongside the drug are also taken into account, the risk of death could be lowered by well over 50% – although the figure will vary from patient to patient.
3rd Mar 2022 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Mar 2022

View this newsletter in full

Covid Hospitalizations in NYC Saw Biggest Racial Gap During Omicron

Black New Yorkers were hospitalized at two times the rate of White New Yorkers during the winter omicron surge. It’s the widest disparity in hospitalizations seen in two years of the pandemic, according to the New York City Health Department. “This is a significant inequity — and a particularly alarming one — so far into the pandemic,” said Michelle Morse, NYC Health’s chief medical officer. And it came during a time when the dominant variant had a lower risk of hospitalization than its predecessor, delta. Despite the city’s relative success in closing race-based vaccination gaps, long-standing inequities in the U.S. health care system have proven difficult to overcome. A new report from the department highlights how a swath of social and economic factors contribute to disparate Covid-19 outcomes based on race.
4th Mar 2022 - Bloomberg

Brazil Is Now Producing Its Own Covid-19 Vaccine Doses

On Valentine’s Day, scientists in Brazil produced a special gift: the first Covid-19 vaccine doses produced fully within the country. These used active pharmaceutical ingredients from Brazil, drew on a technology-transfer agreement with AstraZeneca, and were produced in a new vaccine production facility run by the Oswaldo Cruz Foundation (Fiocruz) and the Immunobiological Technology Institute (Instituto de Tecnologia em Imunobiológicos, or Bio-Manguinhos). The new lab expects to produce 120 million Covid-19 doses by the middle of 2022. This would allow for one dose each for over half of Brazil’s population
3rd Mar 2022 - Forbes

Additional doses of covid-19 vaccine recommended for immunocompromised patients

Additional doses of covid-19 vaccine are recommended for immunocompromised patients, especially for organ transplant recipients who are least able to make antibodies to fight off coronavirus, say experts in The BMJ today. The findings reinforce the importance of additional doses of covid-19 vaccine to protect people with a weakened immune system. It is already known that after vaccination, people with a weakened immune system (immunocompromised) are less able to make antibodies to fight off viruses, such as influenza, than people with a healthy immune system (immunocompetent). But less is known about the response to covid-19 vaccines, particularly mRNA vaccines.
3rd Mar 2022 - News-Medical.Net

COVID-19 vaccine prior to infection may reduce long COVID symptoms

A new study investigates whether receiving two doses of a coronavirus vaccine before a SARS-CoV-2 infection is associated with reduced long COVID symptoms after 12 weeks. COVID-19 vaccines given prior to infection appear effective in resisting long COVID following breakthrough infections or infection after two doses. These findings have relevance for United Kingdom public health initiatives aimed at reducing the prevalence of long Covid in the U.K. population, especially in disadvantaged communities where prevalence is higher.
3rd Mar 2022 - Medical News Today

Survival after in-hospital cardiac arrest 35% lower in COVID-19 patients

Adult COVID-19 patients who had an in-hospital cardiac arrest (IHCA) were 35% less likely to receive potentially life-saving defibrillation without delay and survive to hospital release, according to a study today in JAMA Network Open. University of Iowa at Iowa City researchers led the study of 24,915 patients with IHCA from 286 US hospitals, of whom 5,916 (23.7%) had COVID-19, from March to December 2020. The research team analyzed data from the American Heart Association's Get With the Guidelines Registry (GWTG-R), which compiles information on patients who have IHCA at participating US hospitals. Among the 24,915 patients with IHCA, average age was 64.7 years, 39.5% were women, 24.8% were Black, 61.1% were White, 3.8% were of other races, and 10.3% were of unknown race.
3rd Mar 2022 - CIDRAP

COVID-19: How ventilation, filtration, humidity prevent transmission

Researchers from the University of Oregon measured the amount of virus particles that 11 students with COVID-19 released during certain activities. The research team found higher ventilation, filtration, and humidity levels decreased the amount of virus particles in the air. Scientists believe their findings can assist building operators with creating safer indoor environments.
3rd Mar 2022 - Medical News Today

Covid-19 news: WHO reports 25 per cent rise in depression and anxiety

A World Health Organization (WHO) briefing suggests that depression and anxiety have risen substantially during the coronavirus pandemic, with women and young people among the worst affected. Based on a review of existing evidence into covid-19’s impact on mental health, the briefing largely attributes the rise to the unprecedented stress of social isolation, as well as grieving loved ones, financial worries and fear of infection. Most of the countries surveyed (90 per cent) have included mental health support in their covid-19 recovery plans, however, the WHO has stressed there are still gaps in care.
3rd Mar 2022 - New Scientist

U.S. to share some coronavirus technologies with World Health Organization

The Biden administration will share U.S. government-devised coronavirus technologies with the World Health Organization, a policy shift intended to allow other countries to replicate some American scientific breakthroughs and better fight the pandemic abroad, federal officials said Thursday. Under the plan, some technologies now being developed by the National Institutes of Health will be licensed to the WHO’s COVID-19 Technology Access Pool, senior NIH official Anthony S. Fauci told reporters. The technologies will also be sub-licensed to the United Nations-backed Medicines Patent Pool.
3rd Mar 2022 - Washington Post on MSN.com

Pfizer to supply 10M courses of COVID drug Paxlovid to developing nations in 2022- Reuters

Pfizer (PFE) is expected to provide about 10M courses its COVID-19 therapy Paxlovid to low and middle-income nations in 2022, Reuters reported
3rd Mar 2022 - Seeking Alpha

Regeneron must face patent lawsuit over COVID-19 treatment

Regeneron Pharmaceuticals Inc on Wednesday failed to persuade a federal judge in New York to throw out a lawsuit over its alleged misuse of a patented protein to test its breakthrough COVID-19 treatment. U.S. District Judge Philip Halpern said during an oral argument that he could not grant Regeneron's request at an early stage of the case to find it immune from Allele Biotechnology and Pharmaceuticals Inc's infringement claims.
3rd Mar 2022 - Reuters

WHO recommends Merck's COVID pill for high-risk patients

A World Health Organization (WHO) panel on Wednesday backed the use of Merck & Co Inc's COVID-19 antiviral pill for high-risk patients. The expert panel conditionally recommended the pill, molnupiravir, for patients with non-severe disease who are at high risk of hospitalisation, such as the immunocompromised, the unvaccinated, older people and those with chronic diseases. The recommendation was based on new data from six clinical trials involving 4,796 patients.
3rd Mar 2022 - Reuters

PAHO says women disproportionately affected by COVID-19 pandemic

The Pan American Health Organization (PAHO) on Wednesday said that across the Americas the COVID-19 pandemic has placed the most vulnerable at greater risk and in a region rife with inequality women have been disproportionately affected.
3rd Mar 2022 - Reuters

Lilly, Incyte Arthritis Drug Baricitinib Cut Covid Deaths in Study

Eli Lilly & Co. and Incyte Corp.’s rheumatoid arthritis drug baricitinib reduced the risk of death from Covid-19 in a large U.K. study, bolstering evidence that the class of inflammation-fighting medicines can help infected patients. Adding baricitinib to standard treatments lowered the risk of death among hospitalized Covid patients by 13%, according to results from the U.K. trial, called Recovery, in 8,156 people with the disease. Most of the patients also received steroids, and about one-quarter also got a different type of arthritis drug, Roche Holding AG’s Actemra.
3rd Mar 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Mar 2022

View this newsletter in full

Higher education min. announces clinical trials for 2nd Egyptian COVID-19 vaccine 'EgyVax' begin Tuesday

Higher Education Minister Khaled Abdel Ghaffar will hold a press conference on Tuesday to announce the start of clinical trials for "EgyVax", the second homemade COVID-19 vaccine. The press conference will be attended by Agriculture and Land Reclamation Minister El Sayyed el-Quseir, Head of the Egyptian Drug Authority (EDA) Tamer Essam, Secretary General of University Hospitals Hossam Abdel Ghaffar, as well as representatives of a number of stakeholders. On November 14, the higher education minister announced that the start of the first stage of clinical trials for the first domestically-made coronavirus vaccine "COVI VAX".
2nd Mar 2022 - Egypt Today

Coronavirus vaccine: Indian, Australian researchers devise math model to predict COVID vaccine efficacy

Researchers at the Indian Institute of Science (IISc) here, and Queensland Brain Institute (QBI) in Australia have developed a mathematical model that predicts how antibodies generated by COVID-19 vaccines confer protection against symptomatic infections. The model can potentially optimise the use of available vaccines and speed up the development of new ones. "The reason why predicting vaccine efficacies has been hard is that the processes involved are complex and operate at many interconnected levels," said Narendra Dixit, Professor at the Department of Chemical Engineering, IISc, and the senior author of the study that has been published in Nature Computational Science. "Vaccines trigger a number of different antibodies, each affecting virus growth in the body differently. This in turn affects the dynamics of the infection and the severity of the associated symptoms. Further, different individuals generate different collections of antibodies and in different amounts," he elaborated.
2nd Mar 2022 - Times of India

Vaccine protection against Covid-19 fell substantially for children during Omicron surge

Many vaccinated kids experienced breakthrough infections during the Omicron surge, though protection against hospitalization remained stronger, a large new government-funded study found. The study compared the vaccination status of children ages 5 to 17 who were treated for Covid-19 symptoms in emergency departments, urgent care centers and hospitals across 10 states between April 2021 and February 2022. Researchers reviewed records on nearly 40,000 clinic visits and 1,700 hospitalizations. The study was funded by the US Centers for Disease Control and published Tuesday in its Morbidity and Mortality Weekly Report. The CDC study found vaccinated children ages 5 to 11 -- the youngest and most recently vaccinated group -- were about 46% less likely to have Covid-19 that resulted in care at an urgent care clinic or emergency room, compared with children who were unvaccinated.
2nd Mar 2022 - CNN

Scientists seek to solve mystery of why some people do not catch Covid

Phoebe Garrett has attended university lectures without catching Covid; she even hosted a party where everyone subsequently tested positive except her. “I think I’ve knowingly been exposed about four times,” the 22-year-old from High Wycombe said. In March 2021, she participated in the world’s first Covid-19 challenge trial, which involved dripping live virus into her nose and pegging her nostrils shut for several hours, in a deliberate effort to infect her. Still her body resisted. “We had multiple rounds of tests, and different methods of testing: throat swabs, nose swabs, other types of swabs that I’d never done before like nasal wicks – where you hold a swab in your nose for a minute – as well as blood tests, but I never developed symptoms, never tested positive,” Garrett said. “My mum has always said that our family never gets flu, and I’ve wondered if there’s maybe something behind that.”
2nd Mar 2022 - The Guardian

Covid-19 update: Vaccines protect children from severe symptoms

The global Covid death toll has passed 5.9 million, with a figure of 5,964,704 according to researchers at Johns Hopkins University. Meanwhile, infections have continued past 438 million to a world wide figure of 438,535,937. Covid-19 vaccines protected children and adolescents from severe disease even after the immune-evasive Omicron variant emerged, according to findings from US government reports. After Omicron became dominant in the US late last year, protection against infection and urgent care visits declined for 5- to 17-year-olds who’d received primary inoculations, according to US Centers for Disease Control and Prevention data released Tuesday.
2nd Mar 2022 - Pharmaceutical Technology

FDA warns against use of certain unauthorized COVID antigen tests

The U.S. Food and Drug Administration (FDA) on Tuesday warned people against the use of unauthorized versions of certain COVID-19 rapid antigen tests currently being marketed in the United States. These tests have not been authorized, cleared or approved by the FDA for distribution or use in the United States, the health agency said, adding that they may show false results. The warning was issued against unauthorized versions of Celltrion USA Inc's DiaTrust COVID-19 Ag Rapid Tests, SD Biosensor Inc's STANDARD Q COVID-19 Ag Home Test, and ACON Laboratories' Flowflex SARS-CoV-2 Antigen Rapid Test.
2nd Mar 2022 - Reuters

Inovio lab tests show COVID vaccine weaker against Omicron, trial enrollment paused

Inovio Pharmaceuticals Inc has paused enrollment for an ongoing late-stage study of its lead COVID-19 vaccine candidate after the shot showed significantly lower levels of antibodies against the Omicron variant in lab testing. The vaccine, INO-4800, maintained robust T-cell response in the lab tests though, leading Inovio to plan changes to the trial design and forecast a delay in reporting preliminary efficacy data from the study. T-cells are a key part of the immune system's second line of defense. The company plans to seek regulatory approval to change the main goal of the study to "prevention of severe disease due to COVID-19" from the earlier goal of "prevention of virologically confirmed COVID-19 disease", it said on Tuesday
2nd Mar 2022 - Reuters

Nerve damage may explain some cases of long COVID -U.S. study

A small study of patients suffering from persistent symptoms long after a bout of COVID-19 found that nearly 60% had nerve damage possibly caused by a defective immune response, a finding that could point to new treatments, U.S. researchers reported on Tuesday. The study involved in depth exams of 17 people with so-called long COVID, a condition that arises within three months of a COVID-19 infection and lasts at least two months.
2nd Mar 2022 - Reuters

Merck's Covid Antiviral Gets WHO Backing for High-Risk Patients

Merck & Co.’s Covid-19 antiviral pill was endorsed by a World Health Organization panel for patients in the early stages of disease who face high risk of hospitalization. The WHO panel of international experts, which looked at data from six randomized clinical trials involving more than 4,000 patients, found a moderate certainty that Merck’s molnupiravir reduces the risk of hospital admission and recovery time. The effect on mortality wasn’t so clear. The decision was published Thursday in the BMJ medical journal. Merck’s pill is used in the U.S. and U.K. to treat Covid patients at high risk of severe illness, but its mechanism of action and lesser efficacy have prompted a shift toward Pfizer Inc.’s Paxlovid and other drugs. U.S. National Institutes of Health guidelines specify that molnupiravir should be used only when other medications for outpatients can’t be given.
2nd Mar 2022 - Bloomberg

CDC data suggest Pfizer vaccine protection holds up in kids 5-11, raising questions on earlier study

Does the Pfizer-BioNTech Covid-19 vaccine provide less protection to children aged 5 to 11 than to adolescents 12 to 17? A study from New York state released Monday suggests that’s the case. But new data from 10 states released Tuesday tell a different story. The data, published by the Centers for Disease Control and Prevention, suggest that two doses of the Pfizer vaccine aren’t very protective against infection for either age group in the face of the Omicron variant, but that protection against severe illness appears to be holding up equally in both sets of children. They do not suggest more rapid waning, or more marked waning, among the younger group of children.
1st Mar 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Mar 2022

View this newsletter in full

COVID-19 patent challenges mount as Moderna faces new vaccine lawsuit

A lawsuit filed Monday by Arbutus Biopharma Corp against Moderna Inc is the latest in a small but growing list of high-stakes patent disputes over COVID-19 vaccines and treatments. Arbutus and its partner Genevant Sciences GmbH told a Delaware federal court that Moderna misused its technology for delivering mRNA, which it said allowed Moderna to develop its COVID-19 vaccine at "record speed." The case is not the first patent dispute over COVID-19 breakthroughs, or even the first between Arbutus and Moderna.
1st Mar 2022 - Reuters

Pfizer Covid-19 vaccine effectiveness fell quickly for kids during Omicron surge but still offered some protection against severe disease

The effectiveness of the Pfizer/BioNTech Covid-19 vaccines for children waned quickly during the Omicron surge, especially among children ages 5 to 11, but was still protective against severe disease, according to new data from the New York State Department of Health. Within one month of being fully vaccinated, effectiveness of the Pfizer shots against infection caused by the Omicron variant fell from 68% to just 12% in the youngest children eligible to get the shots: those 5 to 11 years old.
1st Mar 2022 - CNN

Valneva wins first COVID-19 vaccine approval

French-Austrian biotech firm Valneva on Tuesday said its COVID-19 vaccine received emergency authorisation for use in Bahrain, the first approval for its jab. Valneva committed to supplying the Gulf kingdom with one million doses in an advance purchase agreement last year and plans to deliver the first batches at the end of March. The jab, which uses the traditional technology of inactivated virus, "will offer an alternative vaccine to the Bahraini population and medical community", said Valneva president Thomas Lingelbach. Bahrain has reported more than 1,400 COVID-related deaths and cases exceed 500,000. More than 70 percent of the population has received at least one vaccine dose.
1st Mar 2022 - Medical Xpress

COVID-19: Pfizer vaccine less effective at preventing infection in younger than in older children, study suggests

A study suggests Pfizer jabs in children aged five to 11 were less effective at preventing infection than in children aged 12 to 17. The New York State researchers' study shows that during the recent Omicron surge, efficacy against infection among five to 11 year olds who had received Pfizer fell 56% from 68% to 12% while those aged 12-17 only fell 15%. However the study also shows that during the surge, between mid-December and the end of January, the Pfizer jab was protective against severe disease in children aged five to 11.
1st Mar 2022 - Sky News

Effectiveness of Pfizer-BioNTech, Moderna, and Oxford-AstraZeneca COVID-19 vaccines in preventing severe SARS-CoV-2 infection

The coronavirus disease (COVID-19) pandemic led to severe infections and deaths of millions of people worldwide. Initially, non-pharmaceutical measures were used extensively to reduce illness and death. Vaccines were introduced to the treatment resources of the European Union in December 2020. Results from phase 3 and phase 4 clinical trials and the impact of vaccines on older individuals in real-world settings showed high effectiveness. The vaccines that have been authorized for administration in the European Union include Pfizer-BioNTech (BNT162b2), Janssen, Oxford-AstraZeneca (hAdOx1-S-AZD1222), and Moderna (mRNA-1273). Spain is known to report the world’s highest rates of illness and death from COVID-19, especially in the Aragon region. Oxford-AstraZeneca, Moderna, and Pfizer-BioNTech vaccines were widely implemented in Spain and Aragon. Janssen vaccine was added to the vaccination program later
1st Mar 2022 - News-Medical.Net

COVID-19 vaccine doesn't affect IVF success rates - Israeli study

The mRNA coronavirus vaccines have no negative effect on frozen-thawed embryo transfer, which is the core practice of IVF (In-Vitro Fertilization), according to a study from Israel's Sheba Medical Center published in the peer-reviewed medical journal Fertility and Sterility on Thursday. Researchers analyzed 672 embryo transfers among a cohort of 428 women up to the age of 38 who had undergone IVF treatment – including 141 that were either vaccinated with two mRNA coronavirus vaccines or recovered from the virus. The researchers ultimately found no difference in the rate of pregnancy between the vaccinated and unvaccinated test groups.
1st Mar 2022 - The Jerusalem Post

Possible case of deer-to human Covid infection identified in Canada

Canadian researchers believe they have found the first-ever instance of a deer passing the coronavirus to a human, warning that broader surveillance of wildlife is needed to prevent further mutations from developing and spreading undetected. In a paper published last week, but not yet peer reviewed, scientists say at least one case of Covid-19 in humans can be traced to a strain of the virus found in hunted deer. Biologists have previously found white tail deer populations infected with Covid in northeastern regions of the United States, as well as central provinces of Canada. While deer aren’t typically seen as a species that can easily pass on the virus to humans, experts had nonetheless speculated that transmission was possible.
1st Mar 2022 - The Guardian

Covid-19: Sanofi and GSK to seek regulatory authorisation for protein based vaccine

Sanofi and GlaxoSmithKline’s covid-19 vaccine has 57.9% (95% confidence interval 26.5% to 76.7%) efficacy against any symptomatic disease, the companies have reported. In a phase 3 trial in which more than 10 000 adults were randomised to receive two doses of the vaccine or placebo, 21 days apart, researchers found it to have 100% efficacy against severe disease and hospital admission (0 v 10 cases in placebo group after one dose, 0 v 4 cases after two doses) and 75% efficacy against moderate or severe disease (3 v 11 cases). Early data has also indicated 77% efficacy against any symptomatic disease associated with the delta variant, French drug company Sanofi has said. So far, details of the trial have been released only through press release, although the companies said full study results will be published later this year.
1st Mar 2022 - The BMJ

Fears of medical shortages and disease in Ukraine after Russian invasion

Ukraine is running low on critical medical supplies and has had to halt urgent efforts to curb a polio outbreak since Russia invaded the country last week, public health experts say. Medical needs are already acute, with the World Health Organization warning on Sunday that oxygen supplies were running out. read more On Tuesday, WHO told a briefing that some facilities already had no oxygen left. Fears of a wider public health crisis are growing as people flee their homes, health services are interrupted and supplies fail to reach Ukraine, which has also been hit by the COVID-19 pandemic
1st Mar 2022 - Reuters

Arbutus files patent infringement lawsuit against Moderna related to COVID shot

Arbutus Biopharma Corp said on Monday it had filed a lawsuit against Moderna Inc seeking damages for infringement of U.S. patents related to Moderna's COVID-19 vaccine. Shares of Arbutus rose 11% in early trading, while Moderna fell 2.5% on the lawsuit that comes after a federal appeals court in December rejected Moderna's challenge to Arbutus' patents. Arbutus said it developed the so-called lipid nanoparticles (LNP) that enclose genetic materials known as messenger RNA or mRNA, the patents related to which were licensed to Genevant Sciences, a joint venture between Arbutus and Roivant Sciences Ltd
1st Mar 2022 - Reuters

Modified T cells may help those on immunosuppressants; ECMO machines improve COVID survival

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Modified T cells not curbed by immunosuppressants. A technique for modifying virus-attacking T cells might help defend against COVID-19 in patients who must take drugs that suppress the immune system, preliminary findings suggest. Transplant patients, for example, are particularly vulnerable because of the medicines they take to prevent rejection of the new organ
1st Mar 2022 - Reuters

Bahrain approves Valneva's COVID vaccine for emergency use

Bahrain has granted emergency use authorisation to the COVID-19 vaccine developed by France's Valneva, the company said in a statement on Tuesday. Valneva expects to deliver the first shipments of its VLA2001 vaccine to the kingdom at the end of March, after it signed an advance purchase deal for one million doses in December last year. "As the only dual-adjuvanted, inactivated COVID-19 vaccine approved in Bahrain, VLA2001 will provide a differentiated vaccine option to the Bahraini population and medical community," said CEO Thomas Lingelbach.
1st Mar 2022 - Reuters

Novavax expects to apply for full approval of COVID vaccine in H2

Novavax Inc said it would pursue full approval of its COVID-19 vaccine in the second half of this year and forecast total revenue of between $4 billion and $5 billion for 2022. "We expect to gain additional authorizations where we have already filed, including in the U.S. We will pursue full approval of our vaccine including filing our BLA (biologics license application), in the second half of 2022," Chief Executive Officer Stanley Erck said during a post-earnings call. Novavax late last month filed for emergency use authorization of the shot in U.S. adults, a much-awaited step following months of struggles with development and manufacturing problems.
1st Mar 2022 - Reuters

Study: 90% of young ECMO-eligible COVID patients at a US hospital died amid rationing

Nearly 90% of adult COVID-19 patients who were eligible for—but didn't receive—extracorporeal membrane oxygenation (ECMO) during the height of the pandemic died in the hospital owing to a lack of resources, even though they were young and had few underlying health issues, according to a natural experiment published late last week in the American Journal of Respiratory and Critical Care Medicine.
28th Feb 2022 - CIDRAP

COPD Foundation links arms with Ena on antiviral nasal spray ahead of phase 2 trials in COVID-19, flu

The COPD Foundation has stepped up to support the development of Ena Respiratory’s antiviral nasal spray for use in people with chronic lung diseases. Ena is preparing to run phase 2 studies to test the ability of the nasal spray to prevent COVID-19 and influenza. Australia-based Ena raised around $24 million last summer, setting it up to run a phase 1 trial of TLR2/6 agonist INNA-051. By delivering the molecule to the nose, Ena aims to help people fight off viruses such as SARS-CoV-2 and influenza by upregulating innate immune responses in their airway epithelial cells. That mechanism of action put INNA-051 on the radar of the not-for-profit COPD Foundation.
28th Feb 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Mar 2022

View this newsletter in full

S. Korea drops proof of vaccine, test to aid virus response

South Korea will no longer require people to show proof of vaccination or negative tests to enter any indoor space starting Tuesday, removing a key preventive measure during a fast-developing omicron surge that’s elevating hospitalizations and deaths. The Health Ministry’s announcement on Monday came as the country set another one-day record in COVID-19 deaths with 114, breaking the previous high of 112 set on Saturday. More than 710 COVID-19 patients were in critical or serious conditions, up from 200-300 in mid-February, while nearly half of the country’s intensive care units designated for COVID-19 were occupied. Park Hyang, a senior health ministry official, said rescinding the “anti-epidemic pass” would free more health workers to help monitor nearly 800,000 virus patients with mild or moderate symptoms who have been asked to isolate at home to save hospital space.
1st Mar 2022 - The Associated Press

Vaccination reduces risk of long-COVID

Post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is estimated to affect about 2% of the population in the United Kingdom (UK). These long-term symptoms of coronavirus disease 2019 (COVID-19), also called post-acute COVID-19 syndrome, post-COVID-19 syndrome, long COVID, or post-COVID condition, cause functional impairment in the majority of those affected. COVID-19 vaccines have been successful in reducing the rate of incidence of long COVID by lowering the rate of occurrence of SARS-CoV-2 infection. However, the risk for these sequelae post-breakthrough infection remains obscure. Until the end of January 2022, nearly 16% of the UK population were not fully vaccinated despite being eligible for the second vaccination dose. In addition, most ethnic minorities and deprived communities show lower vaccination coverage; these groups also record the highest infection rates.
28th Feb 2022 - News-Medical.Net

Moderna faces new lawsuit over lucrative coronavirus vaccine

Moderna faces yet another patent challenge over its coronavirus vaccine after Arbutus Biopharma and Genevant Sciences, both small biotechnology companies, filed a lawsuit on Monday alleging Moderna hijacked its technology to develop the multibillion-dollar vaccine. Arbutus and Genevant said in their lawsuit that Moderna infringed on their patent for so-called lipid nanoparticle technology, which they say was key in the development of Moderna’s mRNA vaccine and took scientists from Arbutus and Genevant “years of painstaking work to develop and refine.” The suit had been expected after Moderna lost a U.S. Court of Appeals ruling last year in the protracted patent battle. Moderna, a 10-year-old Cambridge-based biotechnology firm that had not marketed any product before the pandemic, has said it expects coronavirus vaccine sales to top $19 billion in 2022. Arbutus and Genevant — a company spearheaded by former Arbutus scientists — could demand some of that as royalties if their challenge succeeds.
28th Feb 2022 - The Washington Post

Will we get a single, variant-proof vaccine for Covid?

This week the government announced additional vaccine booster jabs for the over-75s and suggested a further shot is likely to be needed in the autumn. But imagine if the next Covid vaccine jab you have were the last you would ever need. That’s a dream being actively pursued now by researchers, who feel it could be possible to make a “universal” vaccine against the Sars-CoV-2 virus that would work well not only against all existing variants but any that the virus could plausibly mutate into in the future. Some are thinking even bigger. In January, Joe Biden’s chief medical adviser, Anthony Fauci, and two other experts called for more research into “universal coronavirus vaccines” that would work not only against Sars-CoV-2 but against the many other coronaviruses in animal populations that have the potential to spill over into humans and cause future pandemics. “We need a research approach that can characterise the global ‘coronaviral universe’ in multiple species,” Fauci and colleagues wrote in the New England Journal of Medicine, “and apply this information in developing broadly protective ‘universal’ vaccines against all [coronaviruses].”
28th Feb 2022 - The Guardian

COVID-19 Proteases Inhibited by Repurposed FDA-Approved Drugs

Two notorious SARS-CoV-2 proteases—Mpro and PLpro—were inhibited by drugs that have already been approved for indications other than COVID-19. The identification of potentially useful SARS-CoV-2 antiviral drugs is obviously welcome, but in this case, the findings are especially encouraging. Why? Because the discovery of the inhibitors was accomplished with a novel screening strategy, one that could be used in additional screening studies. Details about the protease inhibitors—and the screening strategy—appeared in Communications Biology, in an article titled, “Identification of SARS-CoV-2 inhibitors targeting Mpro and PLpro using in-cell protease assay.” The in-cell protease assay (ICP) indicated in the article’s title is just one part of the screening strategy. Other parts include antiviral and biochemical activity assessments, as well as structural determinations for rapid identification of protease inhibitors with low cytotoxicity.
28th Feb 2022 - Genetic Engineering & Biotechnology News

Covid-19: Is the government dismantling pandemic systems too hastily?

A last minute row over funding for free covid testing between the Treasury and the Department of Health and Social Care for England nearly derailed the government’s “living with covid” strategy launch last week.1 But the Cabinet eventually signed off drastic cuts to the estimated £15.7bn (€18.7bn; $21bn) testing budget as a key plank of the prime minister’s plan to scrap all remaining covid regulations in England. Duncan Robertson, a policy and strategy analytics academic at Loughborough University, told The BMJ that the latest row over ending restrictions showed that the “false equivalence of the virus versus the economy” was still rearing its head almost two years into the pandemic, even though it is known that “once people are infected, they can’t go to work, and the economy suffers.” It remains to be seen whether the right balance has now been struck and whether the short term gains to the exchequer from letting the public shoulder more responsibility for fighting SARS-CoV-2 are going to pay off, with long term benefits to health and society as a whole.
28th Feb 2022 - The BMJ

Covid-19 news: Omicron immune response protects against BA.2 variant

Data suggests that people who’ve had the BA.1 omicron variant are protected against BA.2, at least in the short term. A preliminary study of coronavirus infection rates suggests that people who have recently been infected by the BA.1 omicron variant are 95 per cent protected against infection with the fast-spreading BA.2 omicron variant. The omicron wave, which began in November, has primarily been driven by the BA.1 variant, but now another variant of omicron, BA.2, seems to be rising to dominance. BA.2 has 32 of the same mutations as BA.1 but it also has 28 that are different. Rapidly rising numbers of BA.2 infections suggest that this variant is even more transmissible than the BA.1 omicron variant. A key problem with the omicron variants is their ability to escape immunity, but data from around 20,000 people in Qatar suggests that people who have recently been infected with BA.1 are 95 per cent protected against catching BA.2 35 to 50 days after infection.
28th Feb 2022 - New Scientist

China perseveres with mRNA COVID shot development amid Omicron, commercial uncertainty

China has spent over a year developing Pfizer-type COVID-19 vaccines that may even help it pivot from stringent "zero-COVID" restrictions, but a changed market and the Omicron variant have muddied prospects before efficacy data has even been published. Still, China is unlikely to join the majority of countries in approving foreign-made vaccines based on messenger RNA (mRNA) technology before making its own, experts said, though a slowing vaccination drive at home and in some other nations and improved supply of approved vaccines have raised questions of viability.
28th Feb 2022 - Reuters

After raking in billions with its COVID shot, Moderna faces patent infringement suit related to vaccine delivery tech

Last last year, Moderna lost a legal bid to invalidate two Arbutus Biopharma patents tied to the delivery of its COVID-19 vaccine. At the time, it wasn’t so much a question of whether Arbutus would sue the messenger RNA vaccine giant for infringement, but when. Now, the other shoe has dropped. Arbutus and Roivant’s Genevant Sciences on Monday filed (PDF) a lawsuit against Moderna in the U.S. District Court for the District of Delaware. In their suit, the companies seek damages for infringement on six patents they claim Moderna infringed with the production and sale of its COVID-19 vaccine. The patents relate to nucleic acid-lipid particles and lipid vesicles, plus compositions and methods for their use, Arbutus and Genevant said in a release. Crucially, the plaintiff companies don’t want to stop Moderna from making, selling or distributing its shot.
28th Feb 2022 - CIDRAP

CDC eases COVID-19 mask guidance, adds metrics for future use

As expected and amid a steadily declining Omicron surge, the Centers for Disease Control and Prevention (CDC) today updated its indoor masking guidance, which would ease indoor use for most parts of the country, according to new baseline measures. The CDC urges states and cities to still look at COVID-19 caseloads when considering masking. But it adds two new metrics for assessing whether to trigger the measure: hospitalization levels and hospital capacity. Most states have already dropped their mask mandates, reflecting a transition to voluntary use in people who want to lower their risk of spreading or contracting the virus. Hawaii as the only state with mandates still in place.
25th Feb 2022 - CIDRAP

Studies: No to very slight risk of hearing loss after COVID vaccine

A team led by Johns Hopkins University researchers investigated 555 cases of sudden sensorineural hearing loss (SSNHL) among adults within 3 weeks of COVID-19 vaccination reported to the Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System (VAERS) during the first 7 months of the US COVID vaccine rollout (Dec 14, 2020, to Jul 16, 2021). The patients had received the Pfizer, Moderna, or Johnson & Johnson (J&J) COVID-19 vaccine. The study period spanned the administration of nearly 187 million vaccine doses in the United States. In addition to the cross-sectional study, the authors also analyzed a multicenter, retrospective case series of 21 patients at two hospitals and one community practice who experienced SSNHL after COVID-19 vaccination. SSNHL is unexplained hearing loss occurring all at once or gradually over a few days. The researchers noted that anecdotal reports of post-COVID vaccination have recently emerged among otolaryngologists and the public.
25th Feb 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Feb 2022

View this newsletter in full

France's Valneva expects recommendation on COVID-19 vaccine by end-March

Valneva expects to start delivering its vaccine in Europe soon after it is recommended for conditional approval by the end of March, the French vaccine maker said on Friday as it received an initial regulatory assessment. Valneva has received a list of questions on its VLA2001 vaccine from the Committee for Medicinal Products for Human Use (CHMP) and should respond in the coming days, it said
27th Feb 2022 - Reuters

Japan's Shionogi seeks approval for COVID-19 pill

Drugmaker Shionogi & Co has applied for approval to make and sell its oral COVID-19 treatment in Japan, the firm said on Friday. Known as S-217622, the drug would become the country's third antiviral pill approved for coronavirus patients, following those developed by Pfizer and Merck
27th Feb 2022 - Reuters

EMA advisory panel backs 3 month interval for Moderna booster

The advisory committee to the European Union's drug regulator on Friday said it has recommended reducing the interval between the second dose and booster dose of Moderna Inc's (MRNA.O) COVID-19 vaccine from six months to three months. Several countries including Greece and France have previously shortened the interval between the first two doses and the booster dose of COVID-19 vaccines, in the face of rising cases due to the Omicron variant. Some also authorised a fourth shot for the vulnerable
27th Feb 2022 - Reuters

COVID-related diabetes may be temporary; racial disparities widen with Omicron infections

Patients with severe COVID-19 who develop diabetes while hospitalized may have only a temporary form of the disease and their blood sugar levels may return to normal afterward, according to new findings. Researchers studied 594 patients who showed signs of diabetes while hospitalized for COVID-19, including 78 with no previous diagnosis of diabetes. Compared to patients with pre-existing diabetes, many of the newly diagnosed patients had less severe blood sugar issues but more serious COVID-19. Roughly a year after leaving the hospital, 40% of the newly diagnosed patients had gone back to blood sugar levels below the cutoff for diabetes
27th Feb 2022 - Reuters

Ontario could have 'really quiet summer' when it comes to COVID-19: Juni

As Ontario gets set to drop some of its COVID-19 mandates, the scientific director of the province's COVID-19 Science Advisory Table is suggesting seasonality and current immunity levels could help keep virus levels low in the spring and summer months. Speaking on Newstalk 580 CFRA's CFRA Live with Andrew Pinsent, epidemiologist Dr. Peter Juni said the province might see a slight increase in viral activity as things open up, but the level of community immunity should keep the worst of it at bay.
27th Feb 2022 - CTV News

The social patterning of Covid-19 vaccine uptake in older adults: A register-based cross-sectional study in Sweden

A broad vaccination coverage is crucial for preventing the spread of Covid-19 and reduce serious illness or death. The aim of this study was to examine social inequalities in Covid-19 vaccination uptake as of 17th May 2021 among Swedish adults aged 60 years and over.
27th Feb 2022 - The Lancet

Urticaria, angioedema events account for 13% of COVID-19 vaccine reactions

Urticaria and/or angioedema events comprised 13% of the adverse reports from clinicians after mRNA vaccinations for COVID-19, according to a presentation at the American Academy of Allergy, Asthma & Immunology Annual Meeting. Noting that hypersensitivity reactions were reported after mass COVID-19 vaccination events were implemented, evidence-based information about side effects can combat vaccine hesitancy, the researchers said.
27th Feb 2022 - Healio

Scientists are working on combo flu and COVID-19 shot, but don't expect one this fall

With more scientists predicting COVID-19 boosters will be needed each year, some are now working on combining those with the annual flu vaccine. The idea, experts say, is a single injection given each fall that protects against seasonal flu and COVID-19. Pharmaceutical companies Moderna and Novavax have already announced plans to work on a combo shot, but don't expect them to be available this upcoming flu season. Instead, Moderna's CEO saying a combo shot could be ready by 2023.
27th Feb 2022 - ABC News

Could COVID-19 increase the risk of dementia?

For most, COVID-19 causes a few days of mild to moderate symptoms, but others feel the effects for months. Some of these effects are neurological, leading scientists to ask whether COVID-19 could increase the risk of dementia. Medical News Today looked at the evidence and spoke with experts to find out the latest views.
27th Feb 2022 - Medical News Today

Coronavirus came from Wuhan market and not Chinese lab, twin studies say

International scientists on Saturday released two major studies which one participant said made it “extraordinarily clear” a market in Wuhan, China was the source of the coronavirus which fueled the Covid-19 pandemic – and not a Chinese government laboratory, a theory championed in the US by rightwing campaigners, columnists and politicians. The question of where Covid-19 came from and how it spread has proved divisive. According to Johns Hopkins University, in Baltimore, after two years the global death toll stands at more than 5.9m, the caseload at 433.7m.
27th Feb 2022 - The Guardian

Arizona health agency reduces frequency of pandemic updates

Arizona’s public health agency on Saturday provided its last planned daily update of the state’s coronavirus dashboard of pandemic data such as additional COVID-19 cases, new deaths and hospitalization levels. The state Department of Health Services announced Feb. 18 that it would switch to weekly dashboard updates starting next Wednesday because the outbreak is slowing and to be consistent with other infectious disease that are reported. “It also will provide a clearer view of COVID-19 trends by smoothing the variability in daily reporting by labs and other sources,” the department’s announcement said.
27th Feb 2022 - Associated Press

Covid-19 Booster Shots Are Slowing as Omicron Surge Fades

Fewer people are getting vaccine booster shots in the U.S. as the Omicron Covid-19 surge fades and more Americans return to normal patterns of life, federal data show. The seven-day average for booster shots administered daily was about 149,000 on Feb. 19, down from a little more than a million in early December, when authorities expanded access and Omicron was first detected in the U.S., the Centers for Disease Control and Prevention estimates. The agency says about half of booster-eligible people have gotten one so far, compared with about 69% of the eligible population who have completed a regular vaccine series.
27th Feb 2022 - Wall Street Journal

New studies again target Wuhan market, not lab, for COVID-19 origin

Scientists released two extensive studies on Saturday that again point to a market in Wuhan, China, as the origin of the coronavirus pandemic, the New York Times reported. The two reports, totaling about 150 pages, have not yet been published in a scientific journal. The researchers analyzed data from a range of sources to uncover how the virus first took hold. They concluded that the coronavirus was present in live mammals sold in the Huanan Seafood Wholesale Market in late 2019.
27th Feb 2022 - MarketWatch

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Feb 2022

View this newsletter in full

ConserV Bioscience pan-coronavirus project has been awarded UK Aid funding by the UK Vaccine Network, delivered by Innovate UK

ConserV Bioscience Limited (“ConserV”), a clinical-stage biotechnology company focused on developing vaccines that protect against endemic and emergent infectious diseases, has been awarded UK Aid funding to advance development of its pan-coronavirus vaccine candidate, UNICOR-v. The project was selected by the UK Vaccine Network (UKVN) for the award under the competition “Vaccines for epidemic diseases: Readiness for clinical development and regulatory submission.” This is one of twenty-two projects funded by the Department of Health and Social Care as part of the UKVN, a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs). ConserV specialises in identifying broadly protective antigens for highly mutable viruses. The grant will fund preclinical development of an intra-dermal formulation of UNICOR-v, which consists of twelve antigens from conserved regions of internal viral proteins that include clusters of reactive T-cell epitopes for multiple human leukocyte antigens (HLAs)
24th Feb 2022 - PharmiWeb

Time between Pfizer and Moderna Covid-19 vaccines can be up to 8 weeks for some people, updated CDC guidance says

The interval between first and second doses of the Pfizer and Moderna Covid-19 vaccines may be as long as eight weeks for certain people, the US Centers for Disease Control and Prevention said in vaccine guidance updated Tuesday.
24th Feb 2022 - CNN

How Often Will We Need to Update COVID Vaccines?

Last June, as the Delta variant sat poised to take the globe by storm, Pfizer’s CEO, Albert Bourla, promised the world speed. Should an ultra-mutated version of SARS-CoV-2 sprout, he said, his company could have a variant-specific shot ready for rollout in about 100 days—a pledge he echoed in November when Omicron reared its head. Now, with the 100-day finish line fast approaching and no clinical-trial data in sight, the company seems unlikely to meet its mark. (I asked Pfizer about this super-speedster timeline; “when we have the data analyzed, we will share an update,” the company responded.) Moderna, which started brewing up an Omicron vaccine around the same time, is eyeing late summer for its own debut. Not that an Omicron vaccine would necessarily make a huge difference, even if Pfizer had made good. In many parts of the world, the variant’s record-breaking wave is receding. Having a bespoke vaccine in 100 days would have been an unprecedented accomplishment, but Omicron was simply “too fast” for a cooked-to-order shot to beat it, says Soumya Swaminathan, the chief scientist at the World Health Organization.
24th Feb 2022 - The Atlantic

Fourth Sinopharm shot won’t boost protection against Omicron, study finds

Immunity wanes six months after three doses of the Sinopharm Covid-19 vaccine are given, but a fourth shot will not provide more protection against the Omicron strain, a study has found. Researchers from Sun Yat-sen University in Guangzhou said their study suggested that “urgent use” of inactivated vaccines – like the Sinopharm one – as a fourth booster shot against variants of concern such as Omicron was “feasible but not ideal”. Recombinant spike protein or mRNA vaccines based on the variants of concern would be good alternatives for a fourth booster, they said. The study suggested that immune response could not be endlessly boosted and there would be a “turning point” after repeated vaccination.
24th Feb 2022 - South China Morning Post

Covid-19: what’s the evidence for vaccinating kids?

When the announcement came last week that all children aged five to 11 in England will be offered a Covid vaccine, emphasis was placed on parental decision-making. But with factors to consider including disease severity, transmission, long Covid and vaccine side-effects, for many parents and guardians this may not be an easy choice. Ian Sample speaks to Prof Adam Finn about how the evidence stacks up, and what parents should be thinking about when deciding whether to vaccinate their five- to 11-year-olds against Covid-19
24th Feb 2022 - The Guardian

Covid-19: Severe infection in pregnancy significantly increases risks, study shows

Severe covid-19 infection in pregnant women significantly increases the risk of harmful outcomes for mothers and babies, a study has found. The study, led by researchers at Oxford Population Health, examined data from the UK Obstetric Surveillance System,2 which holds records for the 1.1 million women who gave birth in UK hospitals between 1 March 2020 and 31 October 2021. Results, published in Acta Obstetricia et Gynecologica Scandinavica, show that in this period, 4436 pregnant women were admitted to hospital with confirmed covid-19 infection. Some 14% (616) had severe infection, 21% (917) had moderate infection, and 65% (2903) had mild infection. Marian Knight, Wellbeing of Women researcher and professor of maternal and child population health at the University of Oxford’s National Perinatal Epidemiology Unit and lead author, said, “Most women give birth safely and have healthy babies, but we know that pregnant women are at greater risk of developing severe covid-19 infection, particularly in the third trimester. This can lead to tragic outcomes, including premature birth and stillbirth.”
24th Feb 2022 - The BMJ

Explainer: How the World Health Organization might face future pandemics

Negotiations on new rules for dealing with pandemics will begin at the World Health Organization on Thursday, with a target date of May 2024 for a treaty to be adopted by the U.N. health agency's 194 member countries. A new pact is among more than 200 recommendations for shoring up the world's defences against new pathogens made by various reviewers following the COVID-19 pandemic that has killed more than 6.2 million people in two years. The WHO itself is facing calls for reform after an independent panel described it as "underpowered" when COVID-19 struck, with limited powers to investigate outbreaks and coordinate containment measures
24th Feb 2022 - Reuters

Omicron BA.2 sub-variant more infectious but no more severe - Africa CDC

The Omicron BA.2 sub-variant of COVID-19 appears to be more infectious than the original BA.1 sub-variant, but does not cause more severe disease, the head of Africa's top public health body said on Thursday citing data from South Africa. "South Africa is reporting that it is more transmissible than the BA.1 variant, but interestingly and very encouragingly the severity seems to be the same," said Dr John Nkengasong, head of the Africa Centres for Disease Control and Prevention. South Africa was one of the first countries to detect the Omicron variant of COVID-19, which has since swept around the globe and become dominant in most places.
24th Feb 2022 - Reuters

AstraZeneca signs deal with Canada for 100000 doses of COVID drug

AstraZeneca plc signed an agreement with Canada for 100,000 doses of its antibody therapy for prevention of COVID-19 in some high-risk patients, the country's government said on Wednesday. AstraZeneca's Evusheld is under review by Health Canada for use as a preventive treatment against the disease in those who are immunocompromised. "While vaccines provide excellent protection, people who are immunocompromised may need additional protection against COVID-19," said Canadian health minister Jean-Yves Duclos.
24th Feb 2022 - Reuters

Novavax starts shipping COVID vaccine to EU states

Novavax Inc said on Wednesday it had started shipping doses of its COVID-19 vaccine to European Union member states, with France, Austria and Germany expected to be the first to receive the shots in the coming days. Shipments of Nuvaxovid to additional EU member states from the company's Netherlands distribution center are expected to quickly follow, adding to the stockpile of the region as it struggles with a surge in infections due to the Omicron variant.
24th Feb 2022 - Reuters

Moderna predicts boost to sales from COVID-19 turning endemic

Moderna Inc (MRNA.O) executives said on Thursday they believe a fourth COVID-19 vaccine shot will be needed late this year due to waning protection from earlier doses, which could push up sales in the second half of 2022. Chief Executive Stephane Bancel stressed that the company's current sales projections for its Spikevax COVID-19 shot - $19 billion in 2022, up from its prior estimate of $18.5 billion - does not include any additional sales to the United States this year. “What is not clear today is what will the U.S. government decide to do for 2022. Will it be a private market, or a mix of private and free vaccines,” Bancel said.
24th Feb 2022 - Reuters

CDC changes guidance and advises longer interval between vaccine doses

Some people getting Pfizer or Moderna Covid vaccines should consider waiting up to eight weeks between the first and second doses, instead of the three or four weeks previously recommended, US health officials said. The Centers for Disease Control and Prevention on Tuesday quietly changed its advice on spacing the shots. CDC officials said they were reacting to research showing that the longer interval can provide more enduring protection against the coronavirus. Research suggests that 12- to 64-year-olds – especially males ages 12 to 39 – can benefit from the longer spacing, the CDC said. They also say the longer wait may help diminish an already rare vaccination side effect: a form of heart inflammation seen in some young men.
23rd Feb 2022 - The Guardian

MIS-C rare in COVID-vaccinated teens, study finds

Multisystem inflammatory syndrome in children (MIS-C) is rare among 12- to 20-year-olds who have received COVID-19 vaccination, a study yesterday in The Lancet Child & Adolescent Health suggests. The study was based on 9 months of follow-up data on US children and young adults ages 12 to 20 who had received at least one dose of the Pfizer-BioNTech COVID vaccine from Dec 14, 2020, to Aug 31, 2021. Only 21 cases out of more than 21 million vaccinated adolescents developed the rare disorder, which mimics Kawasaki's, during the follow-up period. Fifteen of the 21 were diagnosed as having COVID-19 despite vaccination, while 6 developed MIS-C for unknown reasons. "Our results suggest that MIS-C cases following COVID-19 vaccination are rare and that the likelihood of developing MIS-C is much greater in children who are unvaccinated and get COVID-19. COVID-19 vaccination is recommended for everyone aged 5 years and older in the United States for the prevention of COVID-19," said Anna R. Yousaf, MD, the lead author and a researcher at the Centers for Disease Control and Prevention (CDC), in a Lancet press release.
23rd Feb 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Feb 2022

View this newsletter in full

COVID-19 shot interval can be extended to 8 weeks for some -U.S. CDC

Extending the interval between the first two doses of the most widely used COVID-19 vaccines in the country to eight weeks for young men can reduce the rare risk of heart inflammation, U.S. health officials said. The side effect, which has been linked to both Pfizer and Moderna's COVID-19 vaccines, is higher in 12- to 39-year-old men, and therefore the eight-week interval could be optimal for some people aged 12 years and older, the U.S. Centers for Disease Control and Prevention said on Tuesday. The recommended interval between the first two shots will remain three weeks for Pfizer's vaccine and four weeks for Moderna's vaccine in other population groups, the CDC said.
23rd Feb 2022 - Reuters

Coronavirus vaccine protection was much weaker against omicron, data shows

While coronavirus shots still provided protection during the omicron wave, the shield of coverage they offered was weaker than during other surges, according to new data from the Centers for Disease Control and Prevention. The change resulted in much higher rates of infection, hospitalization and death for fully vaccinated adults and even for people who had received boosters. The decline in protection continued a pattern driven by coronavirus vaccines’ reduced effectiveness over time, combined with the increasing contagiousness of the delta and omicron waves. Before delta struck the United States in July, there were five to 10 cases of covid-19 for every 100,000 fully vaccinated adults each week, while the rate for unvaccinated people was 50 to 90 cases. In the delta wave, unvaccinated people were five times as likely to get infected as vaccinated people. With omicron, that difference dropped to less than three times as likely.
23rd Feb 2022 - The Washington Post

Sanofi, Glaxo Seek Covid-19 Vaccine Approval in Crowded Market

Sanofi SA and GlaxoSmithKline PLC said they would seek authorization for their Covid-19 vaccine, a sign that pharmaceutical companies still see an opportunity for new shots despite ebbing demand in the West. While vaccine uptake across the West has slowed significantly after a big push by governments to inoculate their populations, some companies say new vaccines could be used as boosters, or in low- and middle-income countries. Novavax Inc., another latecomer, recently sought emergency approval from the U.S. Food and Drug Administration for its shot, which has already been authorized in the European Union. Sanofi and Glaxo said Wednesday that their shot was 100% effective at preventing severe disease and 75% effective against moderate-to-severe illness. The shot was 57.9% effective at preventing any symptomatic disease, a result the companies said was in line with expected vaccine effectiveness in the current environment, where variants have blunted the protection afforded by shots.
23rd Feb 2022 - The Wall Street Journal

Mental health improved for 1 in 3 children during Covid-19 lockdown

One in three young people said their mental health and wellbeing improved during lockdown measures. Getting more sleep and exercise, and avoiding bullying were among the reasons. More than 17,000 UK school students took part in a study during the last two months of the first national lockdown, answering questions about their experiences of the pandemic, school, home life, and relationships, among others.
23rd Feb 2022 - iNews

People with Covid-19 may face long-term cardiovascular complications, study says

As the Covid-19 pandemic enters its third year, scientists are finding that the coronavirus has far-reaching effects on health beyond the acute phase of illness. One recent study has found that people with Covid-19 are at an increased risk for cardiovascular diseases for at least a year after recovery. The study, published this month in the journal Nature Medicine, used data from US Department of Veterans Affairs national health care databases to follow over 153,000 veterans with a history of Covid-19 infection for up to a year after their recovery. Compared with those who were never infected, people who had a coronavirus infection were more likely to have symptoms including inflammatory heart disease, heart failure, dysrhythmia, heart attacks, strokes and clotting in the long term.
23rd Feb 2022 - CNN

Mental health risk increases for COVID-19 survivors

A study tracking COVID-19 survivors found them more likely to develop mental health issues than other people over the year following diagnosis. The researchers saw an increased risk even for those whose COVID-19 was mild enough that they did not require hospitalization. Conditions the researchers investigated included anxiety, depression, opioid use, and cognitive decline.
23rd Feb 2022 - Medical News Today

COVID-19 shots unlikely to prompt rare inflammation in kids

COVID-19 vaccines are unlikely to trigger a rare inflammatory condition linked to coronavirus infection in children, according to an analysis of U.S. government data published Tuesday. The condition, formally known as multisystem inflammatory syndrome in children, involves fever plus symptoms affecting at least two organs and often includes stomach pain, skin rash or bloodshot eyes. It's a rare complication in kids who have had COVID-19, and very rarely affects adults. The condition often leads to hospitalization, but most patients recover. First reported in the United Kingdom in early 2020, it is sometimes mistaken for Kawasaki disease, which can cause swelling and heart problems. Since February 2020, more than 6,800 cases have been reported in the U.S., according to the Centers for Disease Control and Prevention.
23rd Feb 2022 - The Independent

WHO plans second hub for training countries to make COVID vaccines

The World Health Organization said on Wednesday it has set up a hub in South Korea to train low- and middle-income countries to produce their own vaccines and therapies, and is expanding its COVID-19 vaccine project to a further five nations. The new training hub comes after the U.N. agency set up a technology transfer hub in Cape Town, South Africa, last year to give companies from poor and middle-income countries the know-how to produce COVID-19 vaccines based on mRNA technology. The new hub outside Seoul will provide workforce training to all countries wishing to produce products such as vaccines, insulin, monoclonal antibodies, WHO Director General Tedros Adhanom Ghebreyesus told a press briefing.
23rd Feb 2022 - Reuters

Moderna, Thermo Fisher partner to manufacture COVID vaccine, other drugs

Moderna Inc has entered into a long-term agreement with Thermo Fisher Scientific for the manufacturing of its COVID-19 vaccine and other experimental medicines based on mRNA technology, the companies said on Wednesday. Thermo Fisher had already partnered with Moderna last year to help scale up production of its COVID vaccine, branded as Spikevax. As a part of the 15-year expanded deal, Thermo Fisher would provide dedicated manufacturing capacity in the United States for fill/finish services as well as labeling and packaging services for Spikevax and other mRNA drugs in Moderna's pipeline.
23rd Feb 2022 - Reuters

Sanofi, GSK to seek approval for COVID vaccine candidate

French drugmaker Sanofi and its British partner GlaxoSmithKline are seeking regulatory approval for their COVID-19 vaccine to be used as a booster, as well as a standalone two-dose shot, after several setbacks. The companies said on Wednesday they intended to submit data to regulators from a late-stage trial of the vaccine, and another testing it as a booster, with full results for both studies expected to be published "later this year." Sanofi is hoping for a comeback after falling behind in the race for COVID-19 shots, while GSK, the world's biggest vaccine maker by sales, has not developed its own candidate and is instead supplying its adjuvant technology to developers.
23rd Feb 2022 - Reuters

COVID vaccine supply for global programme outstrips demand for first time

The global project to share COVID-19 vaccines is struggling to place more than 300 million doses in the latest sign the problem with vaccinating the world is now more about demand than supply. Last year, wealthy nations snapped most of the available shots to inoculate their own citizens first, meaning less than a third of people in low-income countries have been vaccinated so far compared with more than 70% in richer nations. As supply and donations have ramped up, however, poorer nations are facing hurdles such as gaps in cold-chain shortage, vaccine hesitancy and a lack of money to support distribution networks, public health officials told Reuters.
23rd Feb 2022 - Reuters

Deutsche Telekom to build global COVID vaccine verification app for WHO

The World Health Organization has signed a contract with Deutsche Telekom subsidiary T-Systems to build a software solution for global electronic verification of coronavirus vaccination certificates, the telecoms company said. The QR code-based software solution will be used for other vaccinations as well, such as polio or yellow fever, T-Systems said in a statement on Wednesday, adding that the WHO would support its 194 member states in building national and regional verification technology. The financial details of the transaction were not disclosed. "Health is a strategic growth area for T-Systems," said T-Systems Chief Executive Officer Adel Al-Saleh.
23rd Feb 2022 - Reuters

Very small blood clot risk after first AstraZeneca COVID shot - UK studies

A large study into rare blood clots linked with AstraZeneca's COVID-19 vaccine found between just one and three cases per million, and only after the first dose, shedding fresh light on the side-effects from the shot. Researchers have sought to analyse any link between COVID-19 vaccines and rare blood clots in the brain, arteries or veins - sometimes accompanied by low platelets, reports of which led many nations last year to pause use of the AstraZeneca shot, which was developed with Oxford University. A study published in the PLOS Medicine journal on Tuesday looked at health records of 46 million adults in England between December 2020 and March 2021 to assess the risk of clots in the month after vaccination with either the Pfizer-BioNTech vaccine or AstraZeneca-Oxford shot, compared with the unvaccinated.
23rd Feb 2022 - Reuters

Is omicron leading us closer to herd immunity against COVID?

Is omicron leading us closer to herd immunity against COVID-19? Experts say it’s not likely that the highly transmissible variant — or any other variant — will lead to herd immunity. “ Herd immunity is an elusive concept and doesn’t apply to coronavirus,” says Dr. Don Milton at the University of Maryland School of Public Health. Herd immunity is when enough of a population is immune to a virus that it’s hard for the germ to spread to those who aren’t protected by vaccination or a prior infection. For example, herd immunity against measles requires about 95% of a community to be immune. Early hopes of herd immunity against the coronavirus faded for several reasons. One is that antibodies developed from available vaccines or previous infection dwindle with time. While vaccines offer strong protection against severe illness, waning antibodies mean it’s still possible to get infected — even for those who are boosted.
23rd Feb 2022 - The Associated Press

3 COVID vaccine doses 99% effective against Omicron, Delta hospitalization

Three doses of the Moderna mRNA COVID-19 vaccine were more effective against infection with the SARS-CoV-2 Delta variant than against Omicron but were highly protective against hospitalization with either subtype, according to a study yesterday in Nature Medicine. A team led by Kaiser Permanente Southern California researchers conducted a test-negative case-control study among 26,683 COVID-19 cases caused by the Delta or Omicron variants in December 2021. Of all cases, 16% were Delta, and 84% were Omicron. The incidence of Omicron infections in Southern California increased from 1.2% to 94.1% from Dec 6 to 31.
23rd Feb 2022 - CIDRAP

U.S. FDA limits use of GlaxoSmithKline-Vir COVID-19 drug

The U.S. Food and Drug Administration said on Wednesday GlaxoSmithKline and Vir Biotech's COVID-19 antibody treatment should not be used in places with circulation of variants that are not susceptible to the drug. Vir has said the drug, sotrovimab, retains neutralizing activity against the emerging BA.2 form of the Omicron coronavirus variant. However, other recent research suggests that the variant showed resistance to nearly all of the monoclonal antibodies they tested, including sotrovimab. The GSK-Vir drug is one of the few COVID-19 treatments shown to have worked against the original Omicron variant, spurring demand.
23rd Feb 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Feb 2022

View this newsletter in full

Moscow, Baku working on Russian Sputnik V COVID-19 vaccine manufacturing in Azerbaijan

Moscow and Baku are working on the Sputnik V COVID-19 vaccine manufacturing in Azerbaijan, Trend reports with reference to Russian media. This is stated in the documents prepared for the talks between President of Russia Vladimir Putin and President of the Republic of Azerbaijan Ilham Aliyev. 'In 2021, 220,000 doses of the Russian Sputnik V vaccine were delivered at the request of the Azerbaijani side. It is scheduled to deliver extra 80,000 doses. No new applications have been received. The organization of vaccine production in the country is being worked out,' said the document.
22nd Feb 2022 - Middle East North Africa Financial Network

DCGI grants EUA to Biological E.’s Covid-19 vaccine for use in adolescents

The Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) to Biological E.’s (BE) Covid-19 vaccine, CORBEVAX, for people aged 12 to 18 years. CORBEVAX is the country’s first domestically developed receptor-binding domain (RBD) protein sub-unit vaccine against the SARS-CoV-2 virus and is adjuvanted with alum and CpG 1018 of Dynavax. The indicated dosage is a two-dose regimen of the vaccine given intramuscularly at a gap of 28 days. In December last year, the drug regulator granted approval to the vaccine for restricted use in adults during emergencies. The latest approval for usage in adolescents is based on interim data from the ongoing Phase II/III clinical trial of the vaccine.
22nd Feb 2022 - Pharmaceutical Technology

Covid cost-cutting will put blinkers on our best Covid research

After a bruising two years in which the UK failed to prove its resilience to a pandemic, the government hopes to re-cast the nation as a scientific superpower: a country that has built on the lessons of the crisis to deliver better research, more precision healthcare, and a more streamlined pathway to new drugs and vaccines. But the government’s decision to substantially cut back on free Covid testing, as part of Boris Johnson’s “living with Covid” strategy, already threatens to undermine pioneering trials and coronavirus surveillance that are the envy of other nations. Together, they are crucial for understanding how drugs keep patients out of hospital, how immunity is holding up in vulnerable care homes and hospitals and how the epidemic is unfolding around us.
22nd Feb 2022 - The Guardian

COVID vaccine for kids: Approval granted to COVID vaccine Corbevax for children between 12-18 years; here

India's first indigenously developed protein sub-unit COVID-19 Vaccine Corbevax is India’s first indigenously developed protein sub-unit COVID-19 vaccine. The vaccine has been developed by Biological E. Limited in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas. "CORBEVAX is a “recombinant protein sub-unit” vaccine, developed from a component of the spike protein on the virus’s surface, which helps the body build the immune response against the virus. The vaccine has the Receptor Binding Domain (RBD) protein as an antigen, and also an optimum adjuvant consisting of Dynavax (DVAX) CpG 1018 and alum," Biological E Limited has said.
22nd Feb 2022 - Times of India

Covid-19: Mexico City gave ivermectin kits to people with covid in “unethical” experiment

The government of Mexico City handed out nearly 200 000 “ivermectin based kits” last year to people who had tested positive for covid-19, without telling them they were subjects in an experiment on the drug’s effectiveness. The results of that experiment were then written up by public officials in an article placed on popular US preprint server SocArXiv.1 It became one of site’s most viewed articles, claiming that ivermectin had reduced hospital admissions by 52-76%. But those officials have been under fire at home since SocArXiv withdrew the paper earlier this month, calling it “either very poor quality or else deliberately false and misleading.” Opposition deputies in Mexico City’s Congress demanded hearings and said they would bring legal action against the paper’s lead author, José Merino, head of the city’s Digital Agency for Public Innovation. Explaining the decision to withdraw the article—the first to be taken down by SocArXiv—the site’s steering committee wrote that it had responded “to a community groundswell beseeching us to act” in order “to prevent the paper from causing additional harm.”2
22nd Feb 2022 - The BMJ

Reinfections with Omicron subvariants are rare, Danish study finds

Getting infected twice with two different Omicron coronavirus subvariants is possible, but rarely happens, a Danish study has found. In Denmark, a more infectious sublineage of the Omicron coronavirus variant known as BA.2 has quickly dethroned the "original" BA.1 variant, which is the most common worldwide, but it has remained unclear whether a person could get infected by both variants. A new study, led by researchers at Denmark's top infectious disease authority, Statens Serum Institut (SSI), shows that people infected with BA.1 can get infected with BA.2 shortly afterwards, but that it is a rare occurrence.
22nd Feb 2022 - Reuters

South Korea says Omicron COVID variant 75% less likely to kill than Delta strain

People infected with the Omicron coronavirus variant are nearly 75% less likely to develop serious illness or die than those who contract the Delta variant, real world data released on Monday by South Korea's health authorities showed. A study by the Korea Disease Control and Prevention Agency (KDCA) of some 67,200 infections confirmed since December showed the Omicron variant's severity and death rates averaged 0.38% and 0.18%, respectively, compared with 1.4% and 0.7% for the Delta cases. The KDCA classed severe cases as people who were hospitalised in intensive care units.
22nd Feb 2022 - Reuters

Top English medic warns new COVID variants could be more resistant to vaccines

England's chief medical officer Chris Whitty warned on Monday there will be new COVID-19 variants and said some of them could be more resistant to vaccines. Earlier, Britain said it would end all coronavirus restrictions in England including mandatory self-isolation for people with COVID-19 and free testing, drawing scepticism from some scientists and political opponents. "We all expect... there to be new variants. And some of those new variants will just disappear," Whitty told a press conference. "But some of them will cause significant problems."
22nd Feb 2022 - Reuters

Antibody triggered by Sinopharm COVID booster wanes after six months - study

Antibodies triggered by a third dose of Sinopharm's COVID-19 shot given to those who completed its primary two-dose regimen dropped sharply after six months, and a fourth shot did not significantly boost them against Omicron, a Chinese study showed. The study, published on Monday before peer-preview, said repeated immunisation using inactivated vaccines such as the Sinopharm shot as a fourth booster may not be ideal to further increase antibody response against Omicron.
22nd Feb 2022 - Reuters

The WHO’s chief scientist on Covid-19 vaccines, patent battles, and speeding up access in Africa

In response to growing concerns over vaccine inequity, the World Health Organization last June announced plans to create a technology transfer and manufacturing hub for vaccines using mRNA technology, starting with Covid-19 shots. The move reflected the difficulty in convincing vaccine makers to share their know-how, an issue that has deadlocked talks at the World Trade Organization over whether to waive intellectual property rights. Now, one of the companies involved in the hub, which is based in South Africa, is moving forward with its own vaccine candidate and the WHO has begun announcing other countries where “spokes” will be located for additional production.
22nd Feb 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Feb 2022

View this newsletter in full

The Science Behind Why Children Fare Better With Covid-19

To understand why children fare better than adults against Covid-19, said Kevan Herold, a professor of immunobiology and internal medicine at Yale University, imagine the immune system as a medieval fortress. The innate response, which includes mucus in the nose and throat that helps trap harmful microbes, is like the moat, keeping assailants out. Innate immunity also includes proteins and cells that trigger the body’s initial immune response. Dr. Herold likens them to cannonballs launched as the enemy is beginning an invasion. A second line of defense, the adaptive immune system, includes T cells and B cells. The adaptive immune system takes longer to initiate a response, but can remember specific weaknesses of past invaders. Think of them as soldiers preparing for battle inside the fortress, Dr. Herold said. Innate immunity doesn’t have the same kind of memory. It relies on patterns associated with harmful microbes more generally. Immunologists have found that children’s immune systems have higher levels of some innate molecules and increased innate responses compared with adults. Experts including Dr. Herold and his wife, Betsy Herold, a pediatric infectious-disease doctor at the Children’s Hospital at Montefiore in the Bronx, think this is key to helping children better fight off the virus that causes Covid-19.
21st Feb 2022 - The Wall Street Journal

Six African countries selected to kick off Covid-19 jab production

The World Health Organization (WHO) has selected the first six African countries to receive the technology needed to produce mRNA vaccines, a move aimed at ramping up production and countering vaccine inequity. Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia will gain access to technology and training to enable them to design and manufacture their own Covid jabs, WHO chief Tedros Adhanom Ghebreyesus said. “No other event like the Covid-19 pandemic has shown that reliance on a few companies to supply global public goods is limiting, and dangerous,” said Tedros. “The best way to address health emergencies and reach universal health coverage is to significantly increase the capacity of all regions to manufacture the health products they need.”
21st Feb 2022 - Evening Standard

'Increased risk' of mental health disorders after Covid-19 infection

Covid-19 is associated with an increased risk of mental health disorders, including anxiety, depression, substance use, and sleep disorders, up to a year after initial infection, a study suggests. The findings, published in the British Medical Journal, suggest that tackling mental health disorders among survivors ought to become a priority for better healthcare overall.
21st Feb 2022 - Nursing Times

Biological E. COVID shot gets India emergency approval for 12-18 age group

Indian vaccine maker Biological E. Ltd said on Monday its COVID-19 vaccine received an emergency use approval in the country for use in children aged 12 to 18. The company's shot, called Corbevax, is the third vaccine approved for use in children aged 12 and above in India, joining Zydus Cadila's DNA shot ZyCoV-D and homegrown player Bharat Biotech's Covaxin. India has so far only started vaccinating children aged 15 and above. According to government figures, more than 76 million children between 15 and 17 have been inoculated mainly using Covaxin.
21st Feb 2022 - Reuters

Synairgen therapy fails in late-stage study in COVID patients; shares sink

Synairgen's inhalable therapy has failed in late-stage trial testing in patients hospitalised with COVID-19, wiping out over 85% of the British drugmaker's stock value on Monday after the blow to the development of its key product. SNG001, an inhalable formulation containing the broad-spectrum antiviral protein interferon beta, was being tested for whether it reduced patients' hospital stay and how rapidly they recovered when given the drug along with standard treatment. The therapy did not show any meaningful change in those parameters compared with a placebo.
21st Feb 2022 - Reuters

Valneva receives 12.5 million pound COVID-19 vaccine manufacturing grant in Scotland

The Scottish unit of French vaccine maker Valneva (VLS.PA) has received a grant of up to 20 million pounds ($27 million) to partly fund the research and development (R&D) of manufacturing its COVID-19 vaccine VLA2001, the company said on Monday. Valneva will receive the funds from Scotland's national economic development agencyScottish Enterprise, which it has been in talks with since December. The funding will come in two tranches. The first grant of up to 12.5 million pounds will support the company's efforts on the VLA2001, its inactivated, whole virus COVID-19 vaccine candidate. The second round of up to 7.5 million pounds will be used for Valneva's other vaccines.
21st Feb 2022 - Reuters

COVID: Do we know the real death toll?

There has long been a debate over how COVID-19-related deaths are recorded. The Johns Hopkins University in the United States, which is widely accepted as a reputable source, puts the global death toll at more than 5.8 million people. Some COVID-deniers insist that this number is exaggerated but they offer no scientific evidence to substantiate their claims. The United Kingdom-based science writer, David Adam, argues in an article he wrote for the British weekly scientific journal Nature that the actual death toll from COVID-19 is much higher than the official figure. The article has reopened the debate on how deaths are recorded differently across the world, and what the best way might be to accurately calculate deaths attributed to COVID-19. Adam argues that records of excess mortality — a standard that requires a comparison of all deaths recorded with those expected to occur — show that many more people than the numbers reported and recorded have died in the pandemic.
21st Feb 2022 - AlJazeera

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Feb 2022

View this newsletter in full

Ending ALL Covid restrictions is 'premature' and 'not based on evidence' BMA warns

The end of Covid-19 restrictions in England is premature and 'not based on current evidence', according to the British Medical Association. Experts have warned an absence of testing and self-isolation will lead to a surge in cases in the country. Prime Minister Boris Johnson said he will present his plan for 'living with Covid' when Parliament returns from a short recess on February 21, with an aim of lifting the requirement to self-isolate by February 24. Dr Chaand Nagpaul, chair of the BMA council, told the Guardian the decision was 'not based on current evidence and is premature,' adding: 'It clearly hasn't been guided by data or done in consultation with the healthcare profession.' He said case rates remained exceptionally high, with one in 20 infected last week, according to the latest Office for National Statistics survey.
19th Feb 2022 - Daily Mail

Covid-19 Vaccines Were Deadly in Rare Cases. Governments Are Now Weighing Compensation.

Vikki Spit’s partner of two decades received his first Covid-19 shot in early May. Two weeks later, he died from a condition doctors for the 48-year-old former punk rock musician attributed to a rare vaccine side effect. Ms. Spit now lives alone in a north England farmhouse, home to the couple’s rescue pets. Finances are tight. She struggles to maintain the online art-resale business her partner, who went by a single legal name, Zion, had started. She’s learning to drive—a task that had always fallen to him. “Sometimes putting a kettle on seems more than I can manage,” she says. Ms. Spit is now among hundreds in the U.K. and elsewhere applying for government compensation for suspected injury caused by Covid-19 vaccines.
19th Feb 2022 - The Wall Street Journal

US FDA considers approving second Covid-19 booster shot – report

US health regulators are looking at authorizing a potential fourth dose of a Covid-19 vaccine in the fall, the Wall Street Journal reported on Saturday, citing sources familiar with the matter. California Surgeon General Dr. Nadine Burke Harris, wearing a light blue blazer and red and yellow patterned blouse, speaks into a microphone at a news conference. California’s first surgeon general on Covid: The Food and Drug Administration (FDA) has been reviewing data to authorize a second booster dose of vaccines from Pfizer and BioNTech and Moderna, the report added. The FDA did not immediately comment. The agency last month cut the interval to get a booster dose of Covid-19 vaccines from Pfizer and BioNTech as well as from Moderna, in a bid to provide better protection sooner against the Omicron variant.
19th Feb 2022 - The Guardian

FDA to allow export of AstraZeneca COVID vaccine lots made at Emergent plant

The U.S. Food and Drug Administration said on Friday it had found four batches of AstraZeneca Plc's (AZN.L) COVID-19 vaccine manufactured at the troubled Emergent BioSolutions facility that were fit to be shipped outside the United States. The health agency said it does not, however, expect to make any more decisions on the remaining lots of the vaccine manufactured at Emergent's Baltimore facility. Last year, the FDA halted operations at the plant, which was producing vaccines for AstraZeneca and Johnson & Johnson (JNJ.N), following a discovery that one vaccine was contaminated with material used in the other. There have been concerns over the shelf life of AstraZeneca's vaccines reaching the world's poorest nations for distribution, Reuters reported on Wednesday.
19th Feb 2022 - Reuters

Analysis: Hong Kong's 'zero-COVID' success now worsens strains of Omicron spike

Hong Kong until recently had an enviable record battling COVID-19, but as an Omicron wave now overwhelms the city, the steps that saved lives are making life unbearable for many of its 7.4 million people. Like an immune system overreacting and harming the person it is meant to protect, the "dynamic zero-COVID" policies that had crushed the virus in Hong Kong have contributed to current woes, experts say. Patients lie in beds in cold, wet parking lots outside overflowing hospitals, isolation facilities are filling up and thousands queue for hours outside testing venues. A 60-fold spike in daily infections this month prompted the government recently to modify its COVID-eradication policies, but the authorities continue aiming to wipe out the virus. The impact of zero tolerance will remain for some time, epidemiologists say.
19th Feb 2022 - Reuters

Pfizer’s Covid-19 Vaccine for Kids Isn’t Working Well Against Omicron So Far, Delaying FDA Review

U.S. health regulators delayed their review of Pfizer Inc.’s Covid-19 vaccine in children under 5 years old because the initial two-dose series so far wasn’t working well against the Omicron variant during testing, people familiar with the decision said. An early look at data showed the vaccine to be effective against the Delta variant during testing while that was the dominant strain, but some vaccinated children developed Covid-19 after Omicron emerged, the people said. So few study subjects, whether vaccinated or unvaccinated, developed Covid-19 during testing thus far that the small number of Omicron cases made the vaccine appear less effective in an early statistical analysis, the people said. As more cases emerge, Pfizer’s shot might wind up providing stronger protection against Omicron, the people said, if the bulk of infections are in unvaccinated subjects.
19th Feb 2022 - The Wall Street Journal

African countries to get mRNA vaccine technology in WHO project

The World Health Organization said on Friday six African countries - Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia - would be the first on the continent to receive the technology needed to produce mRNA vaccines. The technology transfer project, launched last year in Cape Town, aims to help low- and middle-income countries manufacture mRNA vaccines at scale and according to international standards. mRNA is the advanced technology used by companies such as Pfizer-BioNTech and Moderna for their COVID-19 shots.
18th Feb 2022 - Reuters

Why China Doesn’t Have an mRNA Vaccine for Covid

China has done everything in its power to keep the virus outside its borders and protect its people — almost. It has kept cases and deaths remarkably low through a “zero-Covid” strategy that has involved tracking and tracing every case, closed its borders and locked down cities of millions of people. It fostered domestic vaccines that allowed the country to carry out a massive inoculation effort. But two years into the pandemic, China’s 1.4 billion people still don’t have access to one of the most effective coronavirus vaccines the world has to offer. Those vaccines use the breakthrough mRNA technology that was developed and approved in the West, and they have been embraced by dozens of countries.
18th Feb 2022 - The New York Times

China allows COVID boosters of different technologies than primary shots

China is giving COVID-19 booster vaccines using technologies different from the initial injections, in an effort to improve immunisation strategies amid concerns that its most-used jabs appeared to be weaker against variants such as Omicron. Boosting population immunity could be crucial to preparing China to eventually reopen its borders and pivot from its "dynamic zero" strategy, which involves travel curbs and mass testing following dozens of local infections. Experts are watching whether combined Chinese doses would lead to higher effectiveness.
18th Feb 2022 - Reuters

Charities say Moderna patents could hit Africa COVID vaccine hub

Moderna Inc has applied for patents in South Africa relating to its COVID-19 vaccine, prompting fears among charities that the company could eventually seek to prevent a new African vaccine manufacturing hub from making its own version of the mRNA shot, although a Moderna spokeswoman said it did not plan to do so. Moderna spokeswoman Colleen Hussey confirmed it had filed for patents "related to both the COVID-19 vaccine and Moderna's platform technology" in South Africa and elsewhere, after a group of 60 Africa-based charities raised concerns about them. But she reiterated Moderna's October 2020 pledge not to enforce its COVID-19 related patents during the coronavirus pandemic. South Africa's Afrigen Biologics has already used the publicly available sequence of Moderna's vaccine to make its own version of the vaccine, and plans to start human clinical trials in November
17th Feb 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Feb 2022

View this newsletter in full

Moderna's Covid-19 vaccine gets authorisation in Australia for children

Moderna has reported that its Covid-19 vaccine, Spikevax (mRNA-1273), obtained provisional registration from the Therapeutic Goods Administration (TGA) in Australia for active immunisation to prevent Covid-19 in children of the age six to 11 years. The authorised dosage of the messenger ribonucleic acid (mRNA) vaccine is a 50µg dose to be administered as a two-dose regimen. Spikevax was analysed in the ongoing, observer-blind, randomised, placebo-controlled, expansion Phase II KidCOVE clinical trial.
17th Feb 2022 - Pharmaceutical Technology

Hybrid immunity offers increased protection that is longer-lasting against Covid-19 reinfection, studies show

Pfizer/BioNTech's Covid-19 mRNA vaccine provides an added layer of protection against reinfection for people who have been previously infected with Covid-19, as well as increased immune durability over time, according to two studies published Wednesday in the New England Journal of Medicine. The studies offer more insight into the concept of hybrid immunity: when previously infected people, who have "natural immunity," then get vaccine-acquired immunity. One of the studies, conducted out of Israel, found that amongst people who had recovered from Covid-19 infections, reinfections were over four times more common in those who did not receive vaccines than in those who did after the primary infection.
17th Feb 2022 - CNN

Pfizer and BioNTech Omicron-targeted vaccine delayed - BioNTech CEO

Delivery of Pfizer and BioNTech SE's vaccine to combat the Omicron COVID-19 variant was delayed by several weeks due to a slower-than expected data gathering process, BionTech Chief Executive Ugur Sahin told Germany's Bild on Thursday. Once the vaccine is ready, the company would assess whether it was still needed, Sahin said. "If the wave ends, that does not mean it can't begin again," he told Bild in a video interview, adding that BioNTech was in a position to continue creating new vaccines as variants emerged if needed.
17th Feb 2022 - Reuters

Moderna patent application raises fears for Africa COVID vaccine hub

Moderna Inc has applied for patents in South Africa relating to its COVID-19 vaccine, prompting fears the company could eventually seek to prevent a new African vaccine manufacturing hub from making its own version of the mRNA shot. Moderna spokesperson Colleen Hussey confirmed it had filed for patents "related to both the COVID-19 vaccine and Moderna's platform technology" in South Africa and elsewhere, after a group of 60 Africa-based charities raised concerns about them, but said the move would not block vaccine distribution in Africa. She reiterated Moderna's October 2020 pledge not to enforce its COVID-19 related patents during the coronavirus pandemic.
17th Feb 2022 - Reuters

South Africa's health regulator allows use of Merck COVID treatment pill

South Africa's government said it was not planning to buy Merck's COVID-19 treatment pill molnupiravir on Thursday for cost reasons, despite the drug gaining approval from the country's health regulator. Molnupiravir and a rival antiviral pill from Pfizer called Paxlovid have demonstrated efficacy in trials of adults with COVID-19 who are at high risk of serious illness and are now both in use. Countries around the world are negotiating prices with Merck and Pfizer. The U.S. government is paying $700 for each course of molnupiravir, but generic drugmakers will make cheap versions in a deal aimed at giving access to poorer nations
17th Feb 2022 - Reuters

Covid Survivors Deal With Mental-Health Issues Months After Infection

Early Covid-19 survivors were at higher risk of anxiety, depression and a raft of other mental health problems up to a year after their infections, according to a large U.S. study that widens the scope of the pandemic’s economic and societal impact. Even patients who were never sick enough to be hospitalized for Covid were still 68% more likely than their non-infected counterparts to be diagnosed with a sleep disorder, 69% more likely to have an anxiety disorder, and 77% more likely to have a depressive disorder. The relative risk of developing the conditions was significantly higher still in patients hospitalized for Covid, and translates into dozens of additional mental health conditions for every 1,000 coronavirus cases.
17th Feb 2022 - Bloomberg

'Game-Changer' Pfizer Pill Is Easier to Find as Omicron Fades Away

As the omicron wave peaked in the U.S. last month, the first-line treatment for high-risk patients with early Covid dangled out of reach for most. Only a trickle of the new Paxlovid pill from Pfizer Inc. was reaching hospitals and pharmacies. Now, as cases plummet nationwide and the company continues to deliver hundreds of thousands of doses ordered by the federal government to pharmacies, Paxlovid is starting to look downright plentiful. Doctors and health officials in New York, Boston, Colorado and other areas where the omicron wave has receded report that supply seems to be meeting the softening demand. “We’ve seen such a rapid decline in Covid cases that it’s not as needed anymore,” said Asif Merchant, who chairs the Massachusetts Medical Society’s committee on geriatrics. “Having the availability three or four weeks ago would have made a tremendous amount of difference.”
17th Feb 2022 - Bloomberg

Omicron Sub-Variant BA.2 No More Severe Than First Strain: South African Study

The rapidly spreading omicron BA.2 subvariant doesn’t cause significantly more severe disease than the original version, according to a South African study that appears to allay fears it causes harsher illness. Patients infected with the new subvariant suffered from similar rates of severe disease and hospitalization as those with the original omicron strain, according to researchers from the country’s National Institute for Communicable Diseases that analyzed data from a large hospital group and the government laboratory service, looking at almost 100,000 cases. The emergence of BA.2 has caused widespread concern as it appears to be even more transmissible than the original omicron strain that was first identified in South Africa and has since spread around the world, leading to waves of infections in the U.S., Europe and elsewhere. The study indicates that, like the original version, BA.2 is relatively mild in comparison with earlier dominant strains, such as delta.
17th Feb 2022 - Bloomberg

Moderna eyes COVID booster by August, not clear yet if Omicron-specific needed

An Omicron-specific booster could be ready by August, the CEO of U.S. biotech firm Moderna (MRNA.O) told Reuters, but the firm is still gathering clinical data to determine whether that vaccine would offer better protection than a new dose of the existing jab. Last month Moderna began clinical trials for a booster dose specifically designed to target Omicron but initial results from studies in monkeys show the Omicron-specific shot may not offer stronger protection than a new dose of the existing vaccine
17th Feb 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Feb 2022

View this newsletter in full

The COVID-19 pandemic is 80% likely to be in its final stages, says Moderna CEO Stéphane Bancel

Moderna CEO Stéphane Bancel thinks it very likely that Omicron’s relative mildness indicates the final stages of the COVID-19 pandemic, even if the coronavirus will likely stick around forever like the flu. “I think this is a reasonable scenario,” he told CNBC Wednesday. “The way I think about it, there’s an 80% chance that as Omicron evolves or SARS-CoV-2 virus evolves, we are going to see less and less virulent viruses.” Conversely, he warned, there’s also a 20% likelihood that we will still see a new mutation of the coronavirus that is more virulent, as the virus is “really unpredictable.” Less than six weeks ago, Bancel said it was likely people would need second boosters in the coming fall, due to waning efficacy of the first dose. On Wednesday, he again referred to the need for annual boosters, but only for high-risk people such as the over-fifties and those with significant comorbidity factors.
16th Feb 2022 - Fortune

Covid: How new drugs are finally taming the virus

"Two years ago we had nothing,'" says Dr Matthias Schmid, head of infectious diseases at the RVI, who treated the UK's first Covid patient at the end of January 2020. "Now we have a range of treatments available which reduce the severity and prevent death in a huge number of patients." They include the cheap anti-inflammatory steroid dexamethasone, the first drug proven to save the lives of people seriously ill with Covid, which was discovered through a ground-breaking NHS trial. "It's feeling more normal for us," says Dr Miriam Baruch, intensive care medicine consultant. "It's really nice that we can train our doctors for the variety of patients that we get."
16th Feb 2022 - BBC News

COVID-19: New combination of antivirals may be an effective treatment

Researchers from the University of Pennsylvania identified a combination of antiviral drugs they believe to be effective against the SARS-CoV-2 virus. The combination includes the experimental drug brequinar with either the approved drug remdesivir or the approved drug molnupiravir. The research group has so far only tested the drug combination in human respiratory cells and mice. Scientists plan for further research exploring other drug combinations and testing through clinical trials.
16th Feb 2022 - Medical News Today

UK to revamp biosecurity strategy in wake of Covid-19

The UK is revamping its approach to biosecurity after Covid-19 exposed major shortcomings in its ability to respond to biological threats, including the coronavirus pandemic. The new approach will update Britain’s last biological security strategy, published in 2018, which warned of the need to “co-ordinate” government actions better and for a “truly comprehensive approach” to meet biological risks, including pandemics. It also follows a highly critical assessment by a parliamentary committee which found that Covid-19 “exposed profound shortcomings” in Britain’s approach to biosecurity.
16th Feb 2022 - Financial Times

Merck struggles to win European approval for Covid antiviral pill

The European Medicines Agency is unlikely to grant conditional marketing authorisation to Merck’s Covid-19 antiviral pill this month as it grapples with “problematic” data. It is “possible” that the oral Covid drug molnupiravir will not receive approval at all, one of the people said. The EMA declined to comment on its ongoing review. Merck’s drug raised fresh hopes and sent shares in the company rallying late last year after early data from a late-stage trial suggested that it cut in half the risk of death and hospitalisation. But a subsequent analysis revealed its efficacy to be lower than previously thought, at 30 per cent. The US FDA has given its approval but restricted its use. France cancelled its order for the drug amid efficacy concerns.
16th Feb 2022 - Financial Times

Covid-19: Omicron-specific vaccine trials launched in UK as volunteers needed

Volunteers from around the UK are being recruited to take part in a new study for an Omicron booster jab. Led by vaccine giants Moderna, the study will include around 3,000 participants. The jab, which is one of the world's first to specifically tackle the Omicron variant, will be trialed at a number of locations throughout the UK. Research - led by a team based at St George's, University of London - will be conducted through a partnership between Moderna and the National Institute for Health Research (NIHR). The study will see half of the volunteers receive the new Omicron jab, with the other half injected with the regular Moderna booster. Levels of Covid immunity drop several months after a booster dose is administered.
16th Feb 2022 - Daily Record

BioNTech says it won't challenge vaccine copying in Africa

BioNTech's co-founder and top executive said the vaccine maker has no plans to enforce its intellectual property rights should organisations in Africa strike out on their own to produce unauthorised versions of the company's shot. "Our goal is not to keep others from using our technology. Our goal is rather to actively see to it that our technology is available on all continents as safely and as widely as possible," CEO Ugur Sahin told Reuters TV on Wednesday when asked whether he would pursue breaches of patents or patents pending in Africa.
16th Feb 2022 - Reuters

COVID vaccination during pregnancy helps protect babies after birth -U.S. study

Vaccinating pregnant women against the coronavirus may help prevent COVID-19 hospitalizations in infants after they are born, especially if the expecting mothers got the shots later in their pregnancy, U.S. researchers reported on Tuesday. The findings shed light on whether the benefits of vaccination during pregnancy extend to infants who would be too young to receive vaccines. Researchers from several pediatric hospitals and the U.S. Centers for Disease Control and Prevention (CDC) looked at children under six months old between July 2021 and January 2022.
16th Feb 2022 - Reuters

UK health agency says long COVID less common in the vaccinated

Long COVID is less likely to affect vaccinated people than unvaccinated people, a new review of 15 studies by the UK Health Security Agency released on Tuesday has concluded. UKHSA said the people who received two doses of Pfizer-BioNTech, , AstraZeneca or Moderna vaccine, or one dose of the single-shot J&J vaccine, were around half as likely to develop symptoms of long COVID compared to the unvaccinated. "These studies add to the potential benefits of receiving a full course of the COVID-19 vaccination," said Dr Mary Ramsay, head of immunisation at UKHSA.
16th Feb 2022 - Reuters

Coronaviruses are ‘clever’: Evolutionary scenarios for the future of SARS-CoV-2

In the ongoing struggle of SARS-CoV-2’s genes versus our wits, the virus that causes Covid-19 relentlessly probes human defenses with new genetic gambits. New variants of this coronavirus with increasing transmissibility have sprung up every few months, a scenario that is likely to continue. Some experts believe that the pandemic appears to be on an evolutionary slide toward becoming endemic, a “new normal” in which humans and the virus co-exist, as we currently do with influenza. But coronaviruses are clever. While an endemic resolution may be in sight, SARS-CoV-2 could still shock the human species with a devastating evolutionary leap. Here are four possible scenarios, each taken directly from the known evolutionary playbook of coronaviruses.
16th Feb 2022 - STAT News

Covid-19 is not a marathon

A brief survey of pilot fatigue and workload-related issues indicates that the people who staff ICUs are under far more prolonged and intense stress than pilots, with fewer and more limited mitigation options. Given the stakes, shouldn’t health care and research workers have something like the load-management guidelines that air crews have? What do the coaches and managers of elite athletes know that health care leaders don’t know? Legendary coaches like John Wooden, Vince Lombardi, and Bill Bowerman kept practices short, paid attention to recovery, and were constantly asking what they could simplify and stop doing. They also saw themselves as teachers who turned the actual competition over to the athletes and did not micromanage from the sidelines.
16th Feb 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Feb 2022

View this newsletter in full

Scientists identify potential reasons for COVID-19 vaccine hesitancy in US among individuals with chronic health conditions

A recent survey conducted on the adult population in the United States has identified the most common predictive reasons behind coronavirus disease 2019 (COVID-19) vaccine hesitancy. The findings indicate that most of the individuals with chronic health conditions express hesitancy towards the vaccine because of safety and side-effect-related concerns. The study has been published in the journal Health Science Reports.
15th Feb 2022 - News Medical

Novavax receives interim authorisation in Singapore for Covid-19 vaccine

Novavax has received interim authorisation from the Singapore Health Sciences Authority (HSA) for its recombinant, adjuvanted Covid-19 vaccine, Nuvaxovid (NVX-CoV2373). The vaccine is intended for active immunisation to prevent the disease in people aged 18 years and above. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the first SARS-CoV-2 viral strain. The vaccine is formulated with the company’s Matrix-M, a saponin-based adjuvant to boost immune response and elicit greater neutralising antibody levels.
15th Feb 2022 - Pharmaceutical Technology

Exercise right after Covid or flu vaccination may give an antibody boost, study finds

About 90 minutes of light- to moderate-intensity exercise directly after a flu or Covid shot could provide an extra immune boost, suggests a new study. Researchers at Iowa State University found participants who cycled on a stationary bike or took a brisk walk for an hour-and-a-half after getting a jab produced more antibodies in the following four weeks compared to those who sat or continued with their daily routine post-vaccination. The study, published last week in the journal Brain Behavior and Immunity, found similar results after an experiment with mice and treadmills. “Our preliminary results are the first to demonstrate a specific amount of time can enhance the body’s antibody response to the Pfizer-BioNtech Covid-19 vaccine and two vaccines for influenza,” Marian Kohut, lead author of the study, said in a statement.
15th Feb 2022 - The Independent

Vaccine scientists have been chasing variants. Now, they're seeking a universal coronavirus vaccine.

The disconnect highlights the exhausting scientific chase of the last year — and the one that lies ahead. And it underscores a more pressing, overarching conundrum: Is chasing the latest variant a viable strategy? Instead of testing and potentially deploying a new shot when a new variant pops up, what if a single vaccine could thwart all iterations of this coronavirus and the next ones, too?
15th Feb 2022 - The Washington Post

Coronavirus: Long COVID less common in fully vaccinated, UK health agency says

People who have been fully vaccinated against coronavirus are less likely to have long COVID, the UK Health Security Agency has found. Its review looked at 15 national and international studies that were undertaken up until January 2022. The UKHSA found an estimated 2% of the UK population had reported symptoms of long COVID which can last for more than four weeks after their initial infection.
15th Feb 2022 - Sky News

Why Covid-19 vaccines are a freaking miracle

Two years into the Covid-19 pandemic, it’s easy to lament all that has come to pass. The devastating losses. The upending of what we regarded as normal ways of life. The sheer relentlessness of it all. But let’s stop for a moment and consider something else that may have escaped you: You have witnessed — and you are a beneficiary of — a freaking miracle. That miracle is the development, testing, manufacturing, and global distribution of Covid vaccines.
15th Feb 2022 - STAT News

Covid-19: Show us evidence for lifting restrictions, doctors tell Johnson

Doctors and scientists have warned the prime minister that SARS-CoV-2, and not politics, should dictate the pace at which the UK lifts measures to contain the pandemic. They expressed their concern after Boris Johnson’s announcement during prime minister’s questions in parliament on 9 February that he intended to end all remaining restrictions four weeks early if “encouraging trends” continued. The move would see the restrictions, including the current legal requirement to self-isolate after a positive test result, ending as early as 24 February. The BMA responded by calling for the government to provide evidence for its position. Penelope Toff, chair of the association’s public health medicine committee, said, “With case rates still incredibly high and hundreds of deaths each day, the suggestion that self-isolation may be removed this month runs contrary to good public health practice. We must question on what scientific basis this decision is being made, and the government needs to show the evidence behind its proposals.”
15th Feb 2022 - The BMJ

Israel to offer AstraZeneca's Evusheld to immunocompromised people

Israel will start offering AstraZeneca's (AZN.L) antibody cocktail Evusheld, which is used to prevent COVID-19, to people with compromised immune systems who did not get a sufficient antibody boost from vaccines. Evusheld has been approved by the U.S. Food and Drug Administration and has proven to be 83% effective in preventing serious illness and death from COVID-19, the Health Ministry said on Tuesday. It is not a treatment for those already sick or a prevention for those already exposed to the virus, it said. Evusheld will be made available for people 12 and older who weigh more than 40 kg (88 lb), according to a Health Ministry statement.
15th Feb 2022 - Reuters

Prior COVID offers less protection vs Omicron; mRNA booster shot efficacy declines within months

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Previous COVID-19 less protective against Omicron variant. The immune response to COVID-19 helps protect against reinfection, but that protection is weaker against Omicron than it was against earlier variants of the coronavirus, according to new data. A previous SARS-CoV-2 infection protects against Omicron reinfection only 56% of the time, researchers found in a review of national data in Qatar.
15th Feb 2022 - Reuters

Oxford scientists to study effects of COVID variants, shots in pregnancy

Oxford University scientists said on Tuesday they would evaluate the effects of new coronavirus variants on pregnant women and newborns, as well as COVID-19 vaccination effects on complications during pregnancy and after birth. The study comes less than a year after the university found that pregnant women with COVID-19 and their newborn children faced higher risks of complications, such as premature birth and organ failure risk, than was previously known.
15th Feb 2022 - Reuters

China's potential mRNA COVID vaccine weaker against Omicron-study

A Chinese mRNA vaccine candidate showed a sharper drop in neutralizing antibody activity against Omicron than against the non-mutated coronavirus in a small study, but a booster readily induced antibody production in animal tests, a research paper said. The ARCoV vaccine, jointly developed by the Academy of Military Medical Sciences (AMMS), Suzhou Abogen Biosciences and Walvax Biotechnology is currently being tested in an international Phase III clinical trial.
15th Feb 2022 - Reuters

Scientists propose cause of symptoms, treatment for long COVID-19

Two studies to be presented at upcoming professional society meetings suggest that some long COVID-19 symptoms may be related to the effect of SARS-CoV-2 on the vagus nerve and that the use of enhanced external counterpulsation (EECP)—which increases blood flow—can improve some of those symptoms, respectively. Long COVID may affect up to 15% of those who survive their infections, causing symptoms such as fatigue, muscle pain, and cognitive problems that linger for months. Neither study has been peer-reviewed, and the second one comes with the added caveat that it was conducted by an EECP provider.
14th Feb 2022 - CIDRAP

Controlled studies ease worries of widespread long Covid in kids

Uncertainty about the effect of Covid-19 on children is gradually being replaced by reassuring news. First, severe complications from Covid-19 are extremely rare in those under age 18. In Connecticut and Massachusetts, the states where we practice medicine, far fewer than 1% of those under age 18 diagnosed Covid have needed to be hospitalized, and that number is declining. Vaccines have proven immensely effective against the virus, in children and teens as well as in adults. This is grounds for relief, and even celebration.
14th Feb 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Feb 2022

View this newsletter in full

Novavax Files for Conditional Marketing Authorization of COVID-19 Vaccine in Switzerland

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional marketing authorization (CMA) of NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant, for use in adults. “We remain committed to delivering our COVID-19 vaccine, built on a well-understood protein platform used in common vaccines for decades,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We look forward to Swissmedic’s review and, if authorized, delivering the vaccine to Switzerland to help fill the continued gap in vaccination and global distribution channels.”
14th Feb 2022 - The Associated Press

Pfizer and BioNTech to extend rolling submission for Covid-19 vaccine

Pfizer and BioNTech are set to extend their rolling submission to the US Food and Drug Administration (FDA) for amending the emergency use authorization (EUA) of the Covid-19 vaccine to include children aged six months to four years. Currently, the trial in children of this age group is underway and the results on the first two 3µg vaccine doses in these subjects are being submitted to the regulatory agency on an ongoing basis. The companies noted in December last year that the trial underway will analyse a third 3µg dose of the vaccine a minimum of two months following the second shot in subjects of this age. With the trial progressing rapidly, Pfizer and BioNTech intend to wait for the three-dose inoculation data as the companies anticipate it to offer an increased protection level in this age group of children.
14th Feb 2022 - Pharmaceutical Technology

Novavax files for authorization of COVID-19 vaccine in Switzerland

Novavax Inc has submitted an application to Switzerland's drugs regulator for the authorization of its COVID-19 vaccine in adults, the U.S. vaccine maker said on Monday. The submission is based on data from two key clinical trials in the United States and Mexico as well as in the UK that showed the vaccine was 90% effective against COVID-19.
14th Feb 2022 - Reuters

Three Covid vaccines give ‘substantial’ extra protection against serious illness compared to two doses

Three jabs are better than two, according to a new study which finds that people are better protected against Covid after their booster than they are after their second dose. Researchers compared the protection conferred by second and third Pfizer jabs and found the boost gave a better defence against both infection and serious illness. Three doses gave 88 per cent protection against any kind of infection, from asymptomatic to very serious, rising to 97 per cent defence against hospitalisation during the first 3 months after vaccination. But unlike nine months ago, when the Delta variant was spreading through a mostly unvaccinated population, now millions of factory workers have been fully vaccinated and the Omicron variant is proving less severe, the government said. "The risk of widespread lockdowns is very low this year as Vietnam has successfully carried out its COVID-19 vaccination campaign," Dang Duc Anh, director of the National Institute of Hygiene and Epidemiology, told Reuters.
14th Feb 2022 - iNews

Cancer computer models identify new drug combinations to treat Covid-19

By adapting computer models originally developed to understand the biology of cancer cells, UCL researchers have identified new drug combinations with the potential to treat severe cases of Covid-19 infection at different stages of the disease. The findings could help lower the number of Covid-19 related deaths and reduce the strain on healthcare systems. Published in npj Digital Medicine, the study tested the potential impact of interfering with different aspects of SARS-CoV-2 infection and the body’s responses to the virus. Results have identified existing therapeutics that might be suitable for treating Covid-19 patients. Although vaccines and treatments for Covid-19 now exist, additional effective and affordable treatments are still urgently required. Cases of SARS-CoV-2 infection are still highly likely to occur, particularly when new variants arise.
14th Feb 2022 - EurekAlert!

Pardes expects to start larger trial of COVID-19 antiviral pill by mid-year

Pardes Biosciences Inc (PRDS.O) said on Monday it expects to start a mid-to-late-stage trial of its experimental COVID-19 antiviral pill by mid-year, following promising data from early human testing. Interim data from an ongoing early-stage trial has shown that a twice daily intake of the pill, PBI-0451, can trigger potent antiviral activity against SARS-CoV-2 and its emerging variants, Pardes said. The drug was well-tolerated and all adverse events reported so far have been assessed as mild in severity and resolved without intervention, the company added.
14th Feb 2022 - Reuters

Singapore grants interim approval for Novavax's COVID-19 vaccine

Singapore's Health Sciences Authority (HSA) said on Monday it has granted an interim authorisation for Novavax's COVID-19 vaccine. The first batch of the Nuvaxovid vaccine is expected to arrive in Singapore in the next few months, the HSA said.
14th Feb 2022 - Reuters

Moderna eyes UK for next leg of mRNA vaccine manufacturing journey: report

Moderna has already seized domestic manufacturing opportunities in Canada, Australia and Africa. Now, the mRNA pioneer is setting its sights on the U.K.'s "Golden Triangle" for the next leg of its vaccine journey, the Financial Times reports. The company is in late-stage talks with the U.K. to invest in local research and manufacturing, the publication said Sunday. Under the deal, Moderna would also team up with the U.K.’s National Health Service (NHS) for clinical trial work, the FT added. The plan would see Moderna hire staffers to run clinical trials with the NHS, the FT says. Additionally, the biotech would help bolster the U.K.’s pandemic preparedness by building out a manufacturing facility that could swiftly pivot to tackle emerging health threats, the publication noted.
14th Feb 2022 - FiercePharma

AstraZeneca pledges more Evusheld doses to US, bringing its antibody supply deal to $855M

A little more than a month after AstraZeneca sold the U.S. half a million doses of its COVID-19 antibody combo, the British drugmaker and U.S. officials are expanding their supply deal once more. AZ and the U.S. Department of Health and Human Services have locked up an agreement for a total of 1 million additional doses of AstraZeneca’s long-acting antibody cocktail Evusheld, also known as tixagevimab plus cilgavimab, the company said Monday. The deal includes the 500,000 doses the U.S. purchased in January plus an initial order for 700,000 Evusheld doses, which are already being administered around the country, AZ said. The latest tranche, unveiled Monday, covers the purchase of 500,00 doses by the U.S. government. The total value of the agreement for the manufacture, distribution and storage of Evusheld is $855 million, an AstraZeneca spokesperson said over email. The U.S. has now locked up a total of 1.7 million doses from AZ.
14th Feb 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Feb 2022

View this newsletter in full

China approves use of Pfizer's COVID drug Paxlovid

China's medical products regulator said on Saturday it has given conditional approval for Pfizer's COVID-19 drug Paxlovid, making it the first oral pill specifically developed to treat the disease cleared in the country. The National Medical Products Administration said Paxlovid is approved to treat adults who have mild to moderate COVID-19 and high risk of progressing to a severe condition. Further study on the drug needed to be conducted and submitted to the authority, it said. It is not immediately clear if China is already in talks with Pfizer to procure the pill.
12th Feb 2022 - Reuters

US delays decision on COVID vaccine for children under 5

A United States decision on Pfizer and BioNTech’s COVID-19 vaccine for children six months through four years of age has been postponed for at least two months after the Food and Drug Administration (FDA) said it needed more data. The FDA had planned to make a decision on the vaccine based on early trial data because of what it had called a great public health need due to the surge in infections caused by the Omicron variant of the coronavirus. The decision was slated for next week, with a rollout starting as soon as February 21.
12th Feb 2022 - Al Jazeera English

Novartis seeks FDA EUA for Covid-19 antiviral candidate ensovibep

Molecular Partners has reported that its partner Novartis sought emergency use authorization (EUA) for the antiviral candidate, ensovibep, from the US Food and Drug Administration (FDA) to treat Covid-19. A Designed Ankyrin Repeat Protein (DARPin) antiviral therapeutic candidate, ensovibep can specially hinder the SARS-CoV-2 virus’ target cell entry. It comprises three covalently associated individual DARPin domains that can attach to the viral spike protein. With these domains combined into a single molecule, the antiviral candidate can inhibit the SARS-CoV-2 spike protein’s receptor-binding domain (RBD), even when mutations occur in the spike protein. The latest submission to the FDA is based on the entirety of the results from clinical and preclinical studies.
11th Feb 2022 - Pharmaceutical Technology

Lilly to supply up to 600000 doses of COVID-19 drug candidate to U.S.

Eli Lilly and Co said on Thursday it had entered an agreement with the U.S. government to supply up to 600,000 doses of its developmental COVID-19 antibody drug for at least $720 million. Lilly said it has filed a request with the U.S. Food and Drug Administration (FDA) for authorization of the drug, bebtelovimab, to treat mild-to-moderate COVID-19 in some high-risk patients. The U.S. government will accept the doses if the drug receives clearance from the FDA, Lilly said.
11th Feb 2022 - Reuters

Gilead says COVID drug remdesivir shows antiviral activity against Omicron, other variants

Gilead Sciences Inc's drug, remdesivir, showed antiviral activity against Omicron, Delta and other variants of the coronavirus in laboratory studies, the company said on Friday. The study results showed similar activity of remdesivir against the variants and an early ancestral strain of the virus detected in Seattle, Washington, Gilead said. Remdesivir, marketed as Veklury, was approved by the FDA in October 2020 to treat hospitalized COVID-19 patients. Last month, this was expanded to non-hospitalized patients who were at high risk of severe disease
11th Feb 2022 - Reuters

WHO adds Roche's arthritis drug tocilizumab to COVID-19 medicines list

The World Health Organization said on Friday it had added its first monoclonal antibody tocilizumab to its so-called pre-qualification list, an official list of medicines used as a benchmark for procurement by developing countries. The WHO recommended the drug, manufactured by Roche and typically used to treat arthritis, only for patients diagnosed with severe or critical COVID-19.
11th Feb 2022 - Reuters

EU investigates reports of menstrual disorders after mRNA COVID shots

The European Medicines Agency's safety committee said on Friday it was reviewing reports of heavy menstrual bleeding and absence of menstruation from women who had received COVID vaccines from Pfizer/BioNTech and Moderna. The assessment was in view of reports of menstrual disorders after receiving either of the two vaccines, both based on messenger RNA technology, and it was not yet clear whether there was a causal link, the agency said. It was not yet clear whether there was a causal link between the vaccines and the reports, the agency said.
11th Feb 2022 - Reuters

COVID-19: The pandemic is far from over

Some countries are reporting more new coronavirus infections compared with the previous two weeks. Global data trends show that the pandemic isn't over yet. DW sums up the current situation in three charts.
11th Feb 2022 - Deutsche Welle

Boosters wane but showed protection against hospitalization during omicron, CDC study says

Booster shots of the Pfizer-BioNTech and Moderna vaccines lose substantial effectiveness after about four months — but still provided significant protection in keeping people out of the hospital during the omicron surge, according to a study published Friday by the Centers for Disease Control and Prevention. Researchers found the booster shots remained highly effective against moderate and severe covid-19 for about two months after a third dose. But their effectiveness declined substantially after four months, suggesting the need for additional boosters, the study said.
11th Feb 2022 - The Washington Post

F.D.A. Clears Monoclonal Antibody Drug From Eli Lilly

With Covid treatments still in short supply in the United States, the Food and Drug Administration on Friday gave emergency authorization to a new monoclonal antibody drug that has been found in the laboratory to be potent against the Omicron variant of the coronavirus. The Biden administration said it would make the therapy immediately available to states free of charge. The authorization of the treatment, bebtelovimab, means that the United States now has four drugs available for high-risk Covid patients early in the course of their illness that have been found to neutralize the Omicron variant. While there is a greater menu of Covid pills and treatments now than at any other point in the pandemic, the drugs have been so scarce that doctors have been forced to make painful rationing decisions during the Omicron surge.
11th Feb 2022 - The New York Times

Robust Covid-19 Booster Protection Wanes After Four Months, CDC Says

Messenger RNA vaccines’ protection against Covid-19 hospitalization remained strong overall after three doses but did wane over time, the Centers for Disease Control and Prevention said. In the month after the Omicron variant became dominant in the U.S. around Dec. 20, protection against hospitalization fell from 91% within two months of receiving a third shot to 78% after four months, the CDC said Friday, reporting results from a study. The CDC report said the findings underscored the importance of receiving a third mRNA vaccine dose to prevent hospitalization as well as emergency-care visits. Without a third booster shot, protection against hospitalization within two months of a second shot was 71%, and fell to 54% after five months.
11th Feb 2022 - The Wall Street Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Feb 2022

View this newsletter in full

Inhaled vaccine for COVID-19 protects against variants of concern

In a groundbreaking development toward curbing the transmission of SARS-CoV-2, scientists have developed an innovative inhaled vaccine for COVID-19 that offers robust disease protection. Pioneered by a team at McMaster University, the innovative inhaled COVID-19 vaccine has been demonstrated to provide broad, long-lasting protection against the original strain of coronavirus and variants of concern (VOC). A study has signified that the revolutionary inhaled form of COVID-19 vaccine has substantial immune mechanisms and benefits due to being delivered directly into the respiratory tract compared to the standard method injection. The team’s research is published in the journal Cell
10th Feb 2022 - HealthEuropa

AZ halts development of Beta variant COVID-19 vaccine -

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains. The new vaccine – codenamed AZD2816 – started phase 2/3 trials as a booster dose for people vaccinated with Vaxzevria or mRNA vaccines from Pfizer/BioNTech and Moderna last June, when Beta was still the dominant SARS-CoV-2 variant of concern. In its annual results statement, AZ said that it took the decision on the back of data showing that a third dose of Vaxzevria increased the immune response to new variants, including Omicron which is currently driving new COVID-19 cases around the world.
10th Feb 2022 - Pharmaphorum

Chinese firm to get funding boost for vaccine against all Covid-19 strains

Global foundation CEPI will invest another US$8.15 million to support phase 1 and 2 trials of the shot as well as a vaccine for the original coronavirus strain. While existing jabs still offer protection against severe Covid-19 outcomes, new variants such as Delta and Omicron have exposed their limitations
10th Feb 2022 - South China Morning Post

GlaxoSmithKline's COVID-19 antibody delivers as Nucala, Trelegy eclipse £1B landmark

GlaxoSmithKline ended 2021 on a relatively high note saleswise, with its COVID-19 antibody therapy delivering a nice contribution and two key meds surpassing the £1 billion annual revenue mark for the first time. Xevudy, the Vir Biotechnology-partnered COVID therapy, delivered £828 million ($1.12 billion) sales in the fourth quarter. Out of the 25% growth GSK’s drug business enjoyed at constant currencies during the three-month period, the antibody contributed nearly 20 percentage points, the company said. Based on existing supply contracts for more than 1.7 million doses—about 40% of which were delivered in 2021—GSK expects about £1.4 billion in sales from Xevudy in 2022.
10th Feb 2022 - FiercePharma

The US still isn't getting Covid-19 data right

As the Omicron wave recedes in the United States, public health officials are faced with a new round of decision-making on the best way for the country to move forward. It's a critical moment to rebuild the trust that has been lost among weary Americans over the past two years, said Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials. But the best way to gain that trust -- offering a transparent, metric-based approach -- is challenged by a fractured and undervalued health data infrastructure. It's problem that has long plagued the United States and one that has hindered the ability to respond swiftly and pointedly to the Covid-19 pandemic since the beginning.
10th Feb 2022 - CNN

South Korea to roll out Novavax COVID-19 vaccine next week

South Korea will begin offering Novavax Inc.'s COVID-19 vaccine at hospitals, nursing homes and public health centers next week, officials said, adding another tool to fight a fast-developing omicron surge. The country reported a record 54,122 new coronavirus cases on Thursday, according to the Korea Disease Control and Prevention Agency, a 12-fold increase from daily levels seen in mid-January, when omicron first became the country’s dominant strain. But officials are expressing cautious hope that the country’s high vaccination rate will prevent an explosion in serious illnesses and deaths. As of Thursday, 86% of South Koreans were fully vaccinated and 56% had received booster shots under a mass immunization program that has been mainly dependent on Pfizer and Moderna’s mRNA vaccines.
10th Feb 2022 - The Independent

Africa COVID cases could be seven times higher than reported - WHO

The World Health Organization estimates that the number of COVID-19 infections in Africa could be seven times higher than official data suggests, while deaths from the virus could be two to three times higher, its regional head said on Thursday. "We're very much aware that our surveillance systems problems that we had on the continent, with access to testing supplies, for example, have led to an underestimation of the cases," Dr Matshidiso Moeti told a regular online media briefing.
10th Feb 2022 - Reuters

Japan Health Ministry committee approves Pfizer oral COVID-19 drug

A Japanese Health Ministry committee has approved the oral COVID-19 drug made by U.S. drugmaker Pfizer Inc , the ministry said in a statement on Friday. Jiji news agency later reported that Health Minister Shigeyuki Goto had formally approved the drug, a move that officials had said they expected would take place in mid-February. Pfizer applied for approval in January.
10th Feb 2022 - Reuters

Risk of new heart problems jumps after COVID; mRNA shot side effects no different for cancer patients

Researchers at the U.S. Department of Veterans Affairs compared rates of new cardiovascular problems in 153,760 individuals infected with the coronavirus before vaccines were available, 5.6 million people who did not catch the virus, and another 5.9 million people whose data was collected before the pandemic. An average of one year after their recovery from the acute phase of the infection, the COVID-19 survivors had a 63% higher risk for heart attack, a 69% higher risk for problematic irregular heart rhythm, a 52% higher risk of stroke, a 72% higher risk of heart failure, and a nearly three times higher risk of a potentially fatal blood clot in the lungs compared with the other two groups, according to a report published on Monday in Nature
10th Feb 2022 - Reuters

Coronavirus can destroy the placenta and lead to stillbirths

New research suggests the coronavirus can invade and destroy the placenta and lead to stillbirths in infected women. It’s an uncommon outcome for any pregnancy but women with COVID-19 face an elevated risk. Authorities believe vaccination can help prevent these cases. Researchers in 12 countries, including the United States, analyzed placental and autopsy tissue from 64 stillbirths and four newborns who died shortly after birth. The cases all involved unvaccinated women who had COVID-19 during their pregnancy. The study bolsters evidence from small case reports and it confirms that placenta damage rather than an infection of the fetus is the likely cause of many COVID-19-related stillbirths, said Dr. Jeffery Goldstein, a pathologist at Northwestern University’s Feinberg School of Medicine
10th Feb 2022 - The Associated Press

Novavax says COVID-19 shot 80% effective in adolescent study

Novavax Inc said its two-dose vaccine was 80% effective against COVID-19 in a late-stage trial testing the shot in teens aged 12 to 17 years. The trial involved 2,247 adolescents and took place between May and September last year when the Delta variant was the dominant strain in the United States. The vaccine was 82% effective against the variant. The U.S. biotech said it expects to submit applications to global regulators for the shot's use in adolescents during the first quarter.
10th Feb 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Feb 2022

View this newsletter in full

Discovery of Omicron in New York deer raises concern over possible new variants

The discovery of the Omicron variant in white-tailed deer in New York has raised concerns that the species, numbering 30 million in the United States, could become hosts of a new coronavirus strain, a lead researcher said. Blood and some nasal swab samples from 131 deer captured on New York's Staten Island revealed that nearly 15% had virus antibodies. The finding suggested that the animals had previous coronavirus infections and were vulnerable to repeated reinfections with new variants, researchers led by Pennsylvania State University scientists said.
9th Feb 2022 - MSN.com

Indonesia starts testing homegrown COVID vaccine on humans

Indonesia has begun testing a homegrown COVID-19 vaccine on humans after getting the green light from the drug regulator, as the country faces a rising wave of cases. Research on the “Merah Putih” (“Red White”) vaccine – named after the colours of the Indonesian national flag – is led by Airlangga University and Biotis Pharmaceutical Indonesia.
9th Feb 2022 - Al Jazeera

EU regulator reviews extending Pfizer COVID booster for kids aged 12-15

The European Union's drug regulator launched a review to evaluate whether the Pfizer/BioNTech COVID-19 vaccine can be used as a third booster shot in adolescents aged 12 to 15, even after several countries in the region have already started such a campaign. The European Medicines Agency added that a review of booster shots given to 16- and 17-year-oldteenagers was ongoing. Germany's vaccine committee last month recommended that all children between the ages of 12 and 17 receive a booster, following the initial two-shot course
9th Feb 2022 - Reuters

Can you get long COVID after an infection with omicron?

Can you get long COVID after an infection with omicron? It’s too early to know for sure, but many doctors believe it’s possible to have long-term effects from the omicron variant of the virus. Long COVID is usually diagnosed many weeks after a bout with COVID-19. Any long-lasting effects typically appear about 90 days after symptoms of the initial infection go away, Maria Van Kerkhove of the World Health Organization said this week. Overall, some estimates suggest more than a third of COVID-19 survivors will develop some symptoms of long COVID.
9th Feb 2022 - Associated Press

Serious illness, death more common in pregnant women with COVID-19

Pregnant COVID-19 patients are about 40% more likely to develop serious complications or die than their uninfected peers, suggests a study led by University of Utah Health researchers published in JAMA. The retrospective cohort study examined the outcomes of 41,104 women who delivered at 17 US hospitals from Mar 1 to Dec 31, 2020, following them up to Feb 11, 2021. Among the patients, 2,352 had COVID-19 and 11,752 did not.
8th Feb 2022 - CIDRAP

As Pfizer reaps megablockbuster COVID-19 sales, CEO doesn't see virus going away for 'foreseeable future'

Among all biopharma companies, Pfizer has had the most successful response to COVID-19 by bringing to market a hugely lucrative vaccine and a new antiviral pill. Despite its pandemic wins, Pfizer scientists think it’s “unlikely that [SARS-CoV-2] will be fully eradicated in the foreseeable future,” the company's CEO said. That’s because the virus’ global distribution makes it difficult to contain, Pfizer CEO Albert Bourla told analysts on the company's fourth-quarter conference call. The virus also has the ability to “mutate often,” which makes it tough for companies to “stay ahead,” he said. Meanwhile, natural infections don’t confer the sort of durable protection needed stop mutations and spread, Bourla said.
8th Feb 2022 - Fierce Pharma

J&J pauses COVID-19 vaccine production at Dutch plant in temporary pivot to RSV shot: NYT

Johnson & Johnson's COVID-19 vaccine has taken a back seat to mRNA programs from Pfizer and Moderna in many developed nations, but it's still in high demand around the world. That's why news the company recently paused production came as a surprise to some people, including J&J's top customers. Late last year, Johnson & Johnson halted production of its COVID-19 vaccine from its facility in the Dutch city of Leiden, The New York Times reports. Thanks to vaccine stockpiles, it’s unclear whether the pause has affected vaccine supplies, the NYT notes. The pause is only temporary, with J&J gearing up to resume production in Leiden of its COVID shot in March
8th Feb 2022 - Fierce Pharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Feb 2022

View this newsletter in full

Pfizer accused of pandemic profiteering as profits double

Pfizer made nearly $37bn (£27bn) in sales from its Covid-19 vaccine last year – making it one of the most lucrative products in history – and has forecast another bumper year in 2022, with a big boost coming from its Covid-19 pill Paxlovid. The US drugmaker’s overall revenues in 2021 doubled to $81.3bn, and it expects to make record revenues of $98bn to $102bn this year. The bumper sales prompted accusations from campaigners of “pandemic profiteering”. The group Global Justice Now said the annual revenue of $81bn was more than the GDP of most countries and accused Pfizer of “ripping off public health systems”.
8th Feb 2022 - The Guardian

MRNA COVID-19 Vaccines are Safe for Cancer Patients: Study

Cancer patients may not experience more complications with COVID-19 vaccines. mRNA vaccines for COVID-19 are safe for people with cancer as they are for cancer-free individuals. Researchers from Fox Chase Cancer Center tracked short-term side effects from more than 1,753 recipients of the Pfizer BNT162b2 vaccine. They found no other reactions for patients undergoing active cancer treatment or who had completed treatment. The results come from the in-person, phone, and online surveys given to people who received two doses of the mRNA vaccine, three weeks apart, between February 16 and May 15, 2021.
8th Feb 2022 - Medindia

Covid vaccine gives Pfizer sales and profits a big boost

Pfizer's sales in the fourth quarter more than doubled, thanks to strong demand for its Covid-19 vaccine. But that wasn't good enough to satisfy investors. The drugmaker said it posted revenue of $23.8 billion, missing Wall Street's expectations of $24.1 billion. More than half of Pfizer's total sales, $13.9 billion, came from its vaccines unit. The company also reported net income of $3.4 billion, topping analysts' forecasts. Pfizer said it expects $32 billion in sales this year from Comirnaty, the Covid vaccine. Still, that was below Wall Street's expectations of nearly $34 billion. The company's overall sales and profit guidance for 2022 also missed consensus estimates.
8th Feb 2022 - CNN on MSN.com

Novavax falls short of COVID-19 vaccine deliveries

Novavax Inc has delivered just a small fraction of the 2 billion COVID-19 shots it plans to send around the world in 2022 and has delayed first-quarter shipments in Europe and lower income countries such as the Philippines, public officials involved in their government's vaccine rollouts told Reuters. Novavax said it has completed delivery of around 10 million vaccine doses to Indonesia and that shipments of several million shots arrived in Australia and New Zealand on Monday. The company declined to comment on the exact number of deliveries it has made but said it is moving as quickly as possible to ship its contracted supplies for this quarter.
8th Feb 2022 - Reuters

Merck and Partner Ridgeback Fill U.S. Order for Covid-19 Pill

Merck & Co. said that it had provided about 3.1 million courses of its Covid-19 pill to the U.S. government, fulfilling the terms of a federal pact that the drugmaker and partner Ridgeback Biotherapeutics LP agreed to last year. The companies said in a statement on Tuesday that they have completed manufacturing of 10 million courses of the therapy and are on track to make at least 20 million courses this year. The surge in coronavirus infections in the U.S. spurred by the omicron variant has caused demand for treatments to soar.
8th Feb 2022 - Bloomberg

Omicron Poses a Puzzle for Vaccine Makers

As Covid restrictions come down throughout most of the advanced world — even Australia is preparing to welcome international visitors again — public health authorities will need to make decisions on future vaccine protocols. One possibility would be a booster shot formulated specifically for the fast-spreading omicron variant, which is behind the recent growth in infections in the U.S., U.K. and elsewhere. Bloomberg Opinion columnist Therese Raphael and Bloomberg Intelligence pharmaceutical analyst Sam Fazeli discuss a new study that casts doubt on whether such a variant-specific vaccine is worth it.
8th Feb 2022 - Bloomberg

‘Good, not great’: Some long Covid patients see their symptoms improve, but full recovery is elusive

How long does long Covid last? And what does it mean to achieve full recovery? If you ask Joni White, she’ll tell you she just wants to feel like herself again — or something close to it. And she’s almost there. Retired from federal law enforcement, White now describes herself as a glass artist but she’s been out of her studio for more than a year. On New Year’s Eve 2020, Covid-19 hit her so hard she thought she might die. Her infected but asymptomatic sister cared for her for three weeks in a house on the Outer Banks in North Carolina until her crushing headaches, chest tightness, and brain fog eased. But back home in Hillsborough, N.C., White’s headaches and brain fog were still there in April, along with frustration and depression at not being able to carry out what had been ordinary tasks, much less fusing glass into art.
8th Feb 2022 - STAT News

New conditions common 1 to 5 months after positive COVID test

A cohort study of Americans tested for SARS-CoV-2 infection shows that new-onset shortness of breath, heart rhythm abnormalities, and type 2 diabetes were more common 31 to 150 days after testing positive for COVID-19 than among those with negative results. The research was published today in JAMA Network Open. A team led by Centers for Disease Control and Prevention (CDC) researchers examined new signs and symptoms among 144,768 nonhospitalized and 23,933 hospitalized people 20 years and older with a positive COVID-19 test, and 1,227,510 nonhospitalized people with a negative test. Among the 338,024 people younger than 20 years, 25,327 nonhospitalized and 1,338 hospitalized people tested positive, and 260,660 nonhospitalized and 50,699 hospitalized patients had a negative test result.
7th Feb 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Feb 2022

View this newsletter in full

Covid-19 Pill Competing With Pfizer’s Looks for Quick Approval in Japan

Drugmaker Shionogi & Co. said it plans to seek approval this month to sell its Covid-19 treatment pill in Japan after the company found that in human trials the pill had strong virus-fighting ability compared with Pfizer Inc.’s Paxlovid. Shionogi acknowledged that studies of its drug are much smaller than Pfizer’s and have yet to prove effectiveness in preventing serious Covid-19 cases. Pfizer said its final-stage trial, which included more than 2,000 patients, showed Paxlovid cut the risk of hospitalization or death by 89% if patients took the pill within three days of diagnosis. Still, Shionogi said it believed its trials to date, covering about 400 mostly Japanese patients, would offer sufficient evidence to seek approval in Japan, where the Pfizer drug is expected to be approved shortly, but is likely to be in limited supply. Shionogi said its trial found the pill, code-named S-217622, neutralized the virus quickly and didn’t cause serious or lasting side effects. “I think this is excellent data,” said Shionogi’s chief executive, Isao Teshirogi.
7th Feb 2022 - The Wall Street Journal

Covid vaccine: Women having IVF urged to get jabbed as data shows it won’t harm fertility

Leading fertility specialists are urging women having IVF to get vaccinated citing overwhelming evidence that the vaccine is safe for those trying to conceive. IVF doctors told i “mixed messages” and a lack of public messaging at the start of the vaccine rollout had caused concern and anxiety for some patients hoping to get pregnant. The British Fertility Society (BFS) and the Royal College of Obstetricians and Gynaecologists (RCOG) say women having IVF should get vaccinated, with research showing that vaccines do not affect fertility or ovarian reserve.
7th Feb 2022 - iNews

Covid-19 Pill Competing With Pfizer’s Looks for Quick Approval in Japan

University of Oxford to evaluate repurposed antiviral drugs for Covid-19

The University of Oxford in the UK has announced the launch of a research partnership to analyse the repurposing of existing anti-viral drugs for the treatment of Covid-19. Funded by the Medical Research Council and led by Queen’s University Belfast, this $2.16m (£1.6m) project will have specialists from Queen’s, the University of Liverpool and the University of Oxford. As part of the project, the team will quickly detect the new combination of drugs that could effectively treat Covid-19 by using a data-guided approach. Antiviral therapies are specifically utilised for treating viral infections by destroying or preventing the virus growth. In the initial stage, this project will analyse 138 drugs with recognised antiviral activity against the SARS-CoV-2 virus.
7th Feb 2022 - Pharmaceutical Technology

Approval of COVID vaccine made in South Africa could take 3 years, WHO says

The mRNA-based COVID-19 vaccine produced at the World Health Organization-backed vaccine hub in South Africa could take up to three years to get approval if companies do not share their technology and data, a WHO official said on Friday. The WHO-backed tech transfer hub in South Africa was set up in June to give poorer nations the know-how to produce COVID-19 vaccines, after market leaders of the mRNA COVID vaccine, Pfizer , BioNTech and Moderna, declined a WHO request to share their technology and expertise. Martin Friede, coordinator of the WHO Initiative for Vaccine Research, said if companies with approved COVID vaccines or late stage clinical data shared their technology and data with the consortium, the vaccine produced in South Africa could be approved in 12 to 18 months.
7th Feb 2022 - CNBC Africa

South African regulator approves Sinopharm COVID vaccine

South Africa's health regulator said on Monday it had approved a COVID-19 vaccine from China's Sinopharm, although a senior health official said the government was not planning to procure doses for now. South Africa, the country worst-hit by the pandemic in Africa in terms of reported COVID-19 infections and deaths, has used the Pfizer-BioNTech and Johnson & Johnson shots in its vaccination campaig
7th Feb 2022 - Reuters

Easing curbs in 'COVID-zero regions' could cause 2 mln deaths in a year - China study

Restoring normal population mobility to "COVID-zero regions" like China will cause ome 2 million deaths in a year and the key to controlling the virus is developing vaccines that are better at preventing infection, Chinese researchers said. China's "zero-COVID" restrictions have come under growing scrutiny in recent weeks as it hosts the Winter Olympics in Beijing while using sweeping restrictions to try to prevent the spread of the more infectious Omicron variant
7th Feb 2022 - Reuters

Japan to consider early approval for Shionogi COVID pill

Japanese Prime Minister Fumio Kishida said on Monday the government would consider granting conditional early approval for the oral COVID-19 treatment being developed by Shionogi & Co Ltd, as the firm prepares to start a late-stage global trial. Shionogi Chief Executive Isao Teshirogi told reporters that the company could file in Japan for early approval of the drug as soon as next week, and that it could deliver enough doses for 1 million people by the end of March.
7th Feb 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Feb 2022

View this newsletter in full

Three COVID-19 vaccine-infection combinations create quality antibodies

Three encounters with the coronavirus spike protein from varying infection-vaccine combinations grant the immune system a high-quality (and not just high quantity) antibody response, according to a newly published study written by scientists who tracked the antibodies of vaccinated and recovered individuals for two years. The scientists - Prof. Ulrike Protzer, Director of the Institute of Virology at the Technical University of Munich (TUM, Prof. Percy Knolle, Professor of Molecular Immunology at TUM, and Prof. Oliver Keppler (Max von Pettenkofer Institute and Gene Center Munich at LMU) - published their findings online in the peer-reviewed Nature Medicine journal on January 28.
6th Feb 2022 - The Jerusalem Post

Hong Kong logs record 351 Covid-19 cases as official warns of ‘exponential’ rise

Health chief Sophia Chan warns cross-family and social activities during Lunar New Year will trigger an ‘exponential’ rise in cases. Home quarantine will be arranged for asymptomatic patients or those with mild symptoms if case numbers continue to increase
5th Feb 2022 - South China Morning Post

COVID: What we know so far about the Omicron subvariant BA.2

As the highly transmissible Omicron variant of the coronavirus continues its frenetic spread around the world, a new subvariant has been detected in dozens of countries. Omicron was first reported by South Africa in November and has since replaced the Delta variant in most countries as the most prevalent strain. The dominant form of Omicron, known as BA.1, continues to account for the vast majority of confirmed new COVID-19 infections globally, but another subvariant, known as BA.2, has begun to outcompete it in some places. Some early studies have shown BA.2 appears to be more transmissible than the dominant BA.1 subvariant – leading scientists to ramp up their investigations. The strain is being closely watched in countries including Denmark, India and Nepal where it has become dominant, according to the World Health Organization (WHO).
5th Feb 2022 - Al Jazeera English

Omicron Subvariant BA.2 Is Gaining Ground. Should We Worry?

Two years into the pandemic, a mutated version of the omicron variant, known as BA.2, has become the latest challenge to taming Covid-19. The subvariant, detected in at least 57 countries, appears to spread even more easily than the original. But so far it doesn’t seem to cause more severe disease and booster shots remain an effective shield. Scientists are racing to answer a number of questions about this variant as they prepare for the next one.
5th Feb 2022 - Bloomberg

U.S. CDC backs full approval of Moderna's COVID-19 vaccine

The director of the U.S. Centers for Disease Control and Prevention (CDC) signed off on the U.S. Food and Drug Administration's full approval of Moderna Inc's COVID-19 vaccine in those aged 18 and over, the agency said on Friday. The vaccine has been in use under the U.S Food and Drug Administration's emergency use authorization since December 2020, and is now the second fully approved vaccine for COVID-19 in the United States.
5th Feb 2022 - Reuters

Approval of COVID vaccine made in South Africa could take 3 years, WHO says

UK scientists look to repurpose existing antiviral drugs for COVID

British researchers want to repurpose existing antiviral therapies to treat COVID-19, the University of Oxford said on Friday, in an attempt to sidestep lengthy development processes through readily available drugs. Scientists will initially screen 138 drugs with known antiviral activity against the COVID-causing SARS-CoV-2 virus to study and identify potent combinations, the university said in a statement on Friday. The rapid spread of Omicron across the world has also forced researchers to find options that work against the variant. Britain currently has the seventh-highest tally of COVID cases globally, according to Reuters.
5th Feb 2022 - Reuters

U.S. considers lengthening gap between first 2 COVID shots to 8 weeks

U.S. health officials on Friday said they are considering lengthening the recommended interval between the first two doses of the most widely used COVID-19 vaccines to eight weeks to lower the risk of heart inflammation and improve their effectiveness. Dr. Sara Oliver, an official at the U.S. Centers for Disease Control and Prevention (CDC), said the agency was considering making the recommendation for Moderna (MRNA.O) and Pfizer (PFE.N)/BioNTech shots during a meeting of the Advisory Committee on Immunization Practices, a panel of outside advisers to the CDC. In the United States, the recommended interval between the first two shots of Pfizer's vaccine is three weeks and for Moderna's, four.
4th Feb 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Feb 2022

View this newsletter in full

S Africa’s Afrigen makes mRNA COVID vaccine using Moderna data

South Africa’s Afrigen Biologics has used the publicly available sequence of Moderna’s COVID-19 mRNA vaccine to make its own version of the shot, which could be tested in humans before the end of this year, Afrigen’s top executive said on Thursday. The vaccine candidate would be the first to be made based on a widely used vaccine without the assistance and approval of the developer. It is also the first mRNA vaccine designed, developed and produced at lab scale on the African continent. The White House declined to comment. Airlines for America, which represents American Airlines, Delta Air Lines Inc, United Airlines Holdings and others said as of last week international air travel was down 38% over 2019 levels. In December, the Biden administration imposed tougher new rules requiring international air travelers arriving in the United States to obtain a negative COVID-19 test within one day of travel.
3rd Feb 2022 - Al Jazeera English

Study: One-third of students in each class will be infected with COVID-19

A group of researchers from the Technion and Rambam Hospital on Wednesday published a model of the new quarantine outline in the Israeli education system. According to a report on Kan 11 News, the researchers said that a third of the students in each class will be infected with COVID-19 under the current outline which includes two COVID-19 tests per day. The model was presented to researchers at a conference of the Israel National Institute for Health Policy Research. According to the model, in a format of two tests per week, cases will be missed and 30% of students in each class will be infected. The researchers said that if an additional test per week is added and three tests are carried out per week, the morbidity in each class will drop to 20%. They added that performing a test every day would lower the rate of infection in each class to 10%.
3rd Feb 2022 - Arutz Sheva

New Covid-19 vaccine wins regulatory approval in UK

A new Covid-19 vaccine has been approved by the UK’s medicines watchdog, making it the fifth jab to be authorised for use in the country.The Nuvaxovid vaccine, developed by US biotech firm Novavax, will add another string to the UK’s vaccine bow, with 71 per cent of the population having received at least two doses so far, according to Our World in Data. While it has secured the approval of the Medicines and Healthcare products Regulatory Agency (MHRA), it is now up to the Joint Committee on Immunisation and Vaccination (JCIV) to consider it as part of the UK’s vaccination programme, health secretary Sajid Javid explained. The new vaccine uses the same protein-based technology which has been used to develop vaccines for other illnesses such as Hepatitis B.
3rd Feb 2022 - City A.M.

New Covid vaccine Nuvaxovid approved after almost 50,000 people involved in UK clinical trials

A fifth Covid vaccination has been given regulatory approval in the UK. Nuvaxovid, developed by Novavax, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) after safety, quality and effectiveness tests. The next step will see it considered for use in the Covid-19 vaccination programme, health secretary Sajid Javid said today (Thursday, February 3). It follows approval given for Moderna, Oxford/AstraZeneca, Pfizer/BioNTech and the Janssen vaccine (although this is not currently available), the NHS says. Almost 50,000 people were involved in clinical trails for the new vaccine. Mr Javid said: "It is great to see our world renowned medicines regulator approve another COVID-19 vaccine.
3rd Feb 2022 - Wales Online

Can China’s home-grown mRNA Covid-19 vaccine pass its final tests?

China has moved a step closer to developing a home-grown mRNA vaccine against Covid-19, with the publication of early trial results for its prime candidate ARCoV. No serious adverse events were recorded in the phase 1 clinical trial data, published last week by The Lancet Microbe, but scientists said it was too early to judge its success. Large-scale trials of the vaccine – jointly developed by the Academy of Military Science, Walvax Biotechnology and Suzhou Abogen Biosciences – have been delayed since last year. No reason was given by the company, though it has become generally more difficult to recruit unvaccinated volunteers for phase 3 trials.
3rd Feb 2022 - South China Morning Post

Can antiviral drugs turn the tide on COVID-19?

There have been claims that COVID-19 oral antivirals, such as molnupiravir and Paxlovid (nirmatrelvir + ritonavir; Pfizer), will “change the course of the pandemic”. But with limited supply, a short treatment window and only a few patient groups eligible to receive them — can these drugs really turn things around? In this episode of The PJ Pod, Dawn Connelly, features editor, and Julia Robinson, clinical and science editor, look at how these novel drugs work and answer questions from PJ readers on how they will be used in practice. To explain all this, our editors are joined by Penny Ward, visiting professor in pharmaceutical medicine at King’s College London, and Fiona Marra, a consultant infectious disease pharmacist based in Scotland, who has a central role in deploying the COVID-19 antivirals.
3rd Feb 2022 - The Pharmaceutical Journal

Singapore approves Pfizer's oral COVID-19 medicine Paxlovid

Singapore has approved Pfizer's (PFE.N) oral COVID-19 medicine Paxlovid, its Health Sciences Authority (HSA) said on Thursday. Paxlovid is the first COVID-19 oral treatment authorised for use in the city-state for the treatment of mild to moderate cases among adults at high risk of severe disease, HSA said in a statement.
3rd Feb 2022 - Reuters

In world first, S.Africa's Afrigen makes mRNA COVID vaccine using Moderna data

South Africa's Afrigen Biologics has used the publicly available sequence of Moderna Inc's mRNA COVID-19 vaccine to make its own version of the shot, which could be tested in humans before the end of this year, Afrigen's top executive said on Thursday. The vaccine candidate would be the first to be made based on a widely used vaccine without the assistance and approval of the developer. It is also the first mRNA vaccine designed, developed and produced at lab scale on the African continent.
3rd Feb 2022 - Reuters

Placenta may have mechanism that protects fetus from COVID; vaccines safe with rheumatic diseases

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Placenta may shed proteins to keep virus out. The placenta may have a way to protect itself and the fetus from infection with the coronavirus, a small study suggests. Researchers studied 24 women who gave birth between July 2020 and April 2021. Eight had symptomatic COVID-19 in the second trimester, eight were sick from the virus in the third trimester, and eight were not infected during pregnancy.
3rd Feb 2022 - Reuters

Drug distributor McKesson seen getting likely boost from COVID vaccine demand

McKesson Corp is expected to report strong earnings on Wednesday as an Omicron-driven surge in demand for COVID-19 vaccines and tests is likely to insulate the drug distributor from tepid sales of other medical products. The unit which sells medical and surgical products contributes about 5% to McKesson's revenue, compared with rival Cardinal Health Inc's similar business accounting for 10%. A surge in COVID-19 cases due to the fast-spreading Omicron variant has overwhelmed hospitals, forcing them to turn away patients seeking less-urgent procedures.
3rd Feb 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Feb 2022

View this newsletter in full

Covid will always be an epidemic virus — not an endemic one, scientist warns

Last week, the WHO warned that the next Covid variant will be even more contagious than omicron. According to the U.S. Centers for Disease Control and Prevention, an epidemic occurs when the number of cases of a disease increases, often suddenly, above what is usually expected. The WHO declares a disease a pandemic when its growth is exponential and it is spreading globally.
2nd Feb 2022 - CNBC

Study links childhood trauma to Covid-19 vaccine hesitancy

People who suffered trauma in childhood are more likely to be hesitant about having the Covid-19 vaccine, according to a study from Welsh researchers. The study used data from a telephone survey of 2,285 people aged 18 and over living in Wales between December 2020…
2nd Feb 2022 - Nursing Times

Covid vaccine hesitancy could be linked to childhood trauma, research finds

Refusal or reluctance to have a Covid-19 vaccine may be linked to traumatic events in childhood, such as parents separating, neglect, or physical, verbal and sexual abuse, new research suggests. hose who suffer in childhood are also least likely to trust official NHS coronavirus information, follow the rules of restrictions or wear masks during the pandemic, public health experts found. Two years after the virus first reached the UK and a year after vaccines to protect against it were made available for free on the NHS, millions of people have yet to be vaccinated. Almost one in 10 people in the UK – 9% – have still not had a single dose.
2nd Feb 2022 - The Guardian

British trial deliberately infecting young adults with COVID found to be safe

The world's first "human challenge" trial in which volunteers were deliberately exposed to COVID-19 to advance research into the disease was found to be safe in healthy young adults, leaders of the study said on Wednesday. The data supports the safety of this model and lays the groundwork for future studies to test new vaccines and medicines against COVID-19 using this kind of trial by the end of this year, the team added. Open Orphan is running the project, launched last February, with Imperial College London, Britain's vaccines task force and Orphan's clinical company  hVIVO.
2nd Feb 2022 - Reuters

Gilead's COVID-19 antiviral Veklury blew past sales estimates in late 2021 as omicron surged, vaccinations lagged

Just when it looked like Gilead’s COVID-19 medicine Veklury was destined to be crowded out of the market by antibody treatments and antiviral pills, the omicron variant helped spark a surge in sales. In the fourth quarter of last year, with a late boost in demand in December, Veklury rang (PDF) up $1.4 billion in sales, far exceeding the Wall Street consensus estimate of $864 million. Gilead reported the figure Tuesday when it presented its fourth quarter and 2021 earnings. The strong quarter brought Veklury sales up to $5.6 billion for the year and helped push Gilead’s revenue figure to $27.3 billion in 2021, an 11% increase from 2020 that the company attributed almost entirely to Veklury.
2nd Feb 2022 - CNBC

Omicron’s sister variant spreads faster. So why did the one we call Omicron hit first?

Two years into a pandemic that turned us all into amateur virologists, we’ve learned that the best-spreading coronavirus variant will outcompete any slowpokes. But something curious happened with Omicron: The more transmissible version didn’t take off first. The virus that the world came to know as Omicron — and that ignited outbreaks in countries around the world — is just one lineage that made up the broader Omicron grouping. It’s known officially as BA.1. For some time, its sister viruses, including one named BA.2, didn’t seem to be doing much.
2nd Feb 2022 - STAT News

Experts question unusual authorization plan for Covid vaccine for kids under 5

The Food and Drug Administration’s willingness to consider authorizing a Covid-19 vaccine developed by Pfizer and BioNTech for children under the age of 5 — without evidence yet that it would be protective — is raising concerns among some vaccine experts who fear the plan could backfire and undermine vaccine uptake in this group. Pfizer and BioNTech confirmed Tuesday that they had been asked by the FDA to submit an application for the use of a two-dose vaccine in children 6 months to 4 years old. Data on a third shot would be submitted to regulators once they became available in the spring — ostensibly clearing the way for the agency to authorize a three-shot regimen for the youngest children who can get vaccinated. If the two-dose series is authorized by the FDA and the Centers for Disease Control and Prevention, potentially sometime this month, parents who want to vaccinate children under 5 could begin to do so before Pfizer has proven that the va
2nd Feb 2022 - STAT News

BARDA scopes market as it looks to partner next-generation COVID-19 vaccine developers

US government agency, BARDA, is drawing on industry feedback to assist it in understanding the advanced developmental landscape of next-generation COVID-19 vaccines.
1st Feb 2022 - BioPharma-Reporter.com

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Feb 2022

View this newsletter in full

Fast-Spreading Omicron Variant Less Likely to Stop Reinfection

New studies are emerging that suggest the latest version of the highly-infectious omicron variant is transmitting even faster than the original, and mild cases of the first may not offer much protection against future infections. The findings cast doubt on hopes that the wave of omicron that’s sweeping the world may help hasten the end of the pandemic. Calls for governments to treat Covid-19 as endemic like influenza are rising globally as people grow tired of pandemic restrictions, vaccines become more accessible and deaths remain relatively low. The production of neutralizing antibodies during an omicron infection appears related to the severity of the illness, according to one report from researchers at the University of California, San Francisco, that was published online before being peer-reviewed. The milder form of most omicron cases in vaccinated people may leave those who recover from them still vulnerable to existing virus and future variants that emerge, the researchers said.
2nd Feb 2022 - Bloomberg

Omicron subvariant BA.2 likely to have same severity as 'original' -WHO

The emerging BA.2 form of the Omicron coronavirus variant does not seem to be any more severe than the original BA.1 form, an official of the World Health Organization said on Tuesday. Vaccines also continue to provide similar protection against the different forms of Omicron, Dr. Boris Pavlin of the WHO's COVID-19 Response Team told an online briefing. The comments come as the BA.2 subvariant begins to replace Omicron's more common "original" BA.1 subvariant in countries such as Denmark.
1st Feb 2022 - Reuters

Novavax seeks FDA emergency use authorization of its coronavirus vaccine

Novavax announced Monday that it has formally submitted a request for the US Food and Drug Administration to authorize its coronavirus vaccine for emergency use in the United States. The request is based on data that includes the results of two large clinical trials that demonstrated an overall efficacy of about 90% and a "reassuring safety profile," according to the company. "We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Stanley Erck, Novavax's president and chief executive officer, said in the announcement Monday.
1st Feb 2022 - CNN

Study suggests BA.2 COVID-19 subvariant more contagious

A study on how Omicron subvariants transmit in Danish households found that the BA.2 subvariant is substantially more transmissible than the original variant, researchers reported yesterday in preprint findings. BA.2 is now dominant in Denmark, with levels rising in other countries, raising questions about how fast current surges will decline. In South Africa, which first reported the original Omicron variant, BA.2 levels are increasing, but against the backdrop of decreasing infections, Tulio de Oliveira, PhD, who directs South Africa's Centre for Epidemic Response and Innovation, said yesterday.
1st Feb 2022 - CIDRAP

Spanish regulator authorises phase III trials of Hipra's COVID vaccine

The Spanish medicines agency said on Tuesday it had authorised pharmaceutical firm Hipra to carry out phase III trials of the COVID-19 vaccine it is developing Phase III is the last round of testing prior to seeking authorisation to market a drug. Hipra began phase II trials in November that involved testing the vaccine on 1,000 volunteers across ten hospitals in Spain. Hipra has said on its website that it anticipates being able to produce 600 million doses in 2022 and double that figure the following year.
1st Feb 2022 - Reuters

China's most used COVID shots effective against Delta variant-study

China's two most widely used COVID-19 vaccines, developed by Sinovac and Sinopharm, were shown to be effective against the Delta variant of the coronavirus, a study based on real-world data in the country showed on Tuesday. The two vaccines were 52% effective against Delta infection and 60% for symptomatic disease, researchers wrote in a peer-reviewed paper. The study did not generate sufficient data to deliver effectiveness readings for the two vaccines separately or by age groups, researchers from a local disease control authority and two Chinese universities said in a paper published in the Annals of Internal Medicine.
1st Feb 2022 - Reuters

Huge volumes of COVID hospital waste threaten health - WHO

Discarded syringes, used test kits and old vaccine bottles from the COVID-19 pandemic have piled up to create tens of thousands of tonnes of medical waste, threatening human health and the environment, a World Health Organization report said on Tuesday. The material potentially exposes health workers to burns, needle-stick injuries and disease-causing germs, the report said. "We found that COVID-19 has increased healthcare waste loads in facilities to up to 10 times," Maggie Montgomery, a WHO technical officer, told Geneva-based journalists. She said the biggest risk for affected communities was air pollution caused by burning waste at insufficiently high temperatures leading to the release of carcinogens.
1st Feb 2022 - Reuters

US urges Pfizer to apply for under-5 COVID shots

U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years old while awaiting data on a three-dose course, aiming to clear the way for the shots as soon as late February, a person familiar with the matter told The Associated Press. The company’s application is expected to be submitted as soon as Tuesday. Early Pfizer data has shown the vaccine — which is administered to younger kids at one-tenth the strength of the adult shot — is safe and produces an immune response. But last year Pfizer announced the two-dose shot proved to be less effective at preventing COVID-19 in kids ages 2-5, and regulators encouraged the company to add a third dose to the study on the belief that another dose would boost the vaccine’s effectiveness much like booster doses do in adults.
1st Feb 2022 - The Associated Press

Omicron amps up concerns about long COVID and its causes

More than a year after a bout with COVID-19, Rebekah Hogan still suffers from severe brain fog, pain and fatigue that leave her unable to do her nursing job or handle household activities. Long COVID has her questioning her worth as a wife and mother. “Is this permanent? Is this the new norm?” said the 41-year-old Latham, New York, woman, whose three children and husband also have signs of the condition. “I want my life back.’’ More than a third of COVID-19 survivors by some estimates will develop such lingering problems. Now, with omicron sweeping across the globe, scientists are racing to pinpoint the cause of the bedeviling condition and find treatments before a potential explosion in long COVID cases.
1st Feb 2022 - The Associated Press

US gives full approval to Moderna’s COVID-19 vaccine

U.S. health regulators on Monday granted full approval to Moderna’s COVID-19 vaccine, a shot that’s already been given to tens of millions of Americans since its emergency authorization over a year ago. The action by the Food and Drug Administration means the agency has completed the same rigorous, time-consuming review of Moderna’s shot as dozens of other long-established vaccines. The decision was bolstered by real-world evidence from the more than 200 million doses administered in the U.S. since the FDA cleared the shot in December 2020. The FDA granted full approval of Pfizer’s vaccine last August. Public health advocates initially hoped the regulatory distinction would boost public confidence in the shots. But there was no discernable bump in vaccinations after the Pfizer approval, which was heavily promoted by President Joe Biden and other federal officials. Still, regulators said Monday they hoped the extra endorsement would encourage more people to get vaccinated.
1st Feb 2022 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Feb 2022

View this newsletter in full

Moderna's COVID-19 vaccine receives full FDA approval for Americans aged 18 and older

The Moderna Covid-19 vaccine has received full FDA approval for use in all U.S. adults. It is the second vaccine to receive full approval for use in America, joining Pfizer's shot. Approval only applies to the first two shots and the booster dose remains only available under emergency use orders. Without this approval, the jab would only be available under situations of emergency, but now it can be used even beyond the pandemic
31st Jan 2022 - Daily Mail

Japan's Kowa says ivermectin showed 'antiviral effect' against Omicron in research

Japanese trading and pharmaceuticals company Kowa Co Ltd said that anti-parasite drug ivermectin showed an "antiviral effect" against Omicron and other coronavirus variants in joint non-clinical research. The company, which has been working with Tokyo's Kitasato University on testing the drug as a potential treatment for COVID-19, did not provide further details. The original Reuters story misstated that ivermectin was "effective" against Omicron in Phase III clinical trials, which are conducted in humans. Clinical trials are ongoing, but promotion of ivermectin as a COVID-19 treatment has generated controversy.
31st Jan 2022 - Reuters

The New Clues About Who Will Develop Long Covid

Asthma. Unhealthy gut bacteria. The presence of autoantibodies, usually associated with autoimmune conditions. These are among the risk factors identified in new studies as potentially making someone at greater risk of developing long Covid, a condition in which wide-ranging symptoms such as fatigue, brain fog and racing heart rate persist months after an initial Covid-19 infection. The studies help advance scientists’ understanding of the biology behind long Covid, and provide clues to potential treatments. Patients with autoantibodies, for instance, might get relief from existing treatments for lupus, an autoimmune disease. The variety of reasons one person might get long Covid and another might not also reinforce scientists’ increasing belief that there won’t be a single cause or treatment for the condition.
31st Jan 2022 - The Wall Street Journal

Merck's COVID pill is last choice for U.S. patients, global use varies

Merck & Co's new antiviral pill, once touted as a potential game changer for treating COVID-19, is the last choice among four available options for at-risk patients given its relatively low efficacy and potential safety issues, U.S. doctors, healthcare systems and pharmacies told Reuters. A rival oral treatment from Pfizer Inc, Paxlovid, is in high demand, followed by an intravenous antibody therapy made by GlaxoSmithKline and Vir Biotechnology. With supplies of those products tight, doctors facing a surge of cases caused by the Omicron variant are also turning to Gilead Sciences Inc's remdesivir, an antiviral that needs to be given as three daily infusions to help high-risk COVID patients avoid hospitalization.
31st Jan 2022 - Reuters

Omicron amps up concerns about long COVID and its causes

Covid-Infected HIV Patient Developed Mutations, Study Shows

A South African woman suffering from inadequately treated HIV, and who harbored Covid-19 for nine months saw the respiratory virus develop at least 21 mutations while in her body, according to a study. Once the 22-year-old adhered to the anti-retroviral medication used to treat HIV and her immune system strengthened she was able to overcome the Covid-19 infection within six to nine weeks, the study, led by scientists from Stellenbosch and the University of KwaZulu-Natal showed. The research has not been peer reviewed.The study adds to evidence that Covid-19 may mutate rapidly when harbored by immunosuppressed individuals, such as those not taking medication to treat HIV, and this may lead to the development of new variants. The beta variant, which the patient in the study was infected with, was discovered in South Africa, as was omicron.
31st Jan 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 31st Jan 2022

View this newsletter in full

Lung Abnormalities Found in Long Covid Patients With Breathing Issues

Researchers have discovered abnormalities in the lungs of long Covid patients who have breathlessness which cannot be detected with routine tests. The Explain study uses xenon, an odourless, colourless, tasteless and chemically non-reactive gas, to investigate possible lung damage in the patients who have not been admitted to hospital, but continue to experience the symptom. The initial results of the study suggest there is significantly impaired gas transfer from the lungs to the bloodstream in the long Covid patients despite other tests – including CT scans – coming back as normal. The study’s chief investigator, Fergus Gleeson, professor of radiology at the University of Oxford and consultant radiologist at Oxford University Hospitals NHS Foundation Trust, said: “We knew from our post-hospital Covid study that xenon could detect abnormalities when the CT scan and other lung function tests are normal.
29th Jan 2022 - Bloomberg

Hong Kong Study Shows Hamster-to-Human Covid Spread: Lancet

Hong Kong researchers have found evidence that pet hamsters can spread Covid-19 to people, and linked the animals to human infections in the city. The study, published Saturday in The Lancet as a preprint and not yet peer-reviewed, provided the first documented evidence of hamster-to-human transmission of the Delta variant. Researchers from the University of Hong Kong and the city’s government found two independent cases of such transmission, after testing viral swabs and blood samples from animals collected from local pet shops. The hamsters in question were infected around Nov. 21, before they were imported to Hong Kong, suggesting pet animal trade may be a pathway that facilitates Covid to spread across borders, according to the study.
29th Jan 2022 - Bloomberg

COVID: New Omicron subvariant ‘appears to have growth advantage’

The BA.2 subtype of the Omicron coronavirus variant appears to have a substantial growth advantage over the currently predominant BA.1 type, the United Kingdom’s Health Security Agency has said. UKHSA said on Friday there was an increased growth rate of BA.2 compared with BA.1 in all regions of England where there were enough cases to compare them, and that “the apparent growth advantage is currently substantial”.
29th Jan 2022 - Al Jazeera English

Merck's COVID-19 pill active against Omicron in lab studies

Merck & Co Inc and partner Ridgeback Biotherapeutics said on Friday six lab studies showed their experimental oral COVID-19 drug molnupiravir was active against the fast-spreading Omicron variant. The data evaluated the antiviral activity of molnupiravir and other COVID-19 antiviral agents against COVID-19 variants of concern. Molnupiravir is yet to be studied against Omicron in human studies, the companies said. Molnupiravir and a rival oral pill from Pfizer Inc were authorized in the United States in December and are considered as important tools against Omicron.
29th Jan 2022 - Reuters

Omicron subtype has apparent transmission advantage - UKHSA

The BA.2 subtype of the Omicron coronavirus variant appears to have a substantial growth advantage over the currently predominant BA.1 type, Britain's UK Health Security Agency said on Friday. UKHSA said that there was an increased growth rate of BA.2 compared with BA.1 in all regions of England where there were enough cases to compare them, and that "the apparent growth advantage is currently substantial". "We now know that BA.2 has an increased growth rate which can be seen in all regions in England," said Dr Susan Hopkins, Chief Medical Advisor for the UKHSA.
29th Jan 2022 - Reuters

Easier to produce COVID vaccine shows promise in trials; nasal spray vaccine booster works in mice

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. New COVID-19 vaccine could be manufactured like flu shots. A COVID-19 vaccine that can be produced locally in low- and middle-income countries is yielding promising results in early clinical trials, researchers say. The NDV-HXP-S vaccine, developed at Icahn School of Medicine at Mount Sinai in New York City, uses an engineered version of the harmless Newcastle disease virus studded with coronavirus spike proteins to teach the immune system to recognize and attack the virus that causes COVID.
29th Jan 2022 - Reuters

U.S. orders 100 million additional COVID-19 tests to give out

The United States government has procured more than 100 million additional COVID-19 tests from testmaker iHealth Lab Inc. as part of the White House's plan to distribute 500 million free at-home tests across the country, the Department of Defense said Friday. Starting in January, the U.S. government has been allowing households to order four free at-home COVID-19 tests from the website COVIDTests.gov with shipping expected within seven to 12 days of ordering. The batch of free tests are aimed at easing a shortage of tests across the country amid increased demand during the rapid spread of the Omicron variant.
29th Jan 2022 - Reuters

Covid-19 Vaccine Booster Shot Cuts Omicron Death Risk by 95%, U.K. Study Shows

Three shots of vaccine cut the risk of death from Covid-19 by 95% in those age 50 and older during the Omicron surge in the U.K., according to an early study that showed immunity from vaccination held up well against the worst effects of the disease even among older people who are most at risk. The analysis, by the U.K. Health Security Agency, offers a glimpse of how effective vaccination is against death from Omicron in a highly boosted population. The U.K. government in December hurried to offer boosters to everyone 16 and older, expanding a campaign that up to that point had only applied to people 50 and older, and those with certain health conditions. The highly mutated Omicron variant can easily evade immune defenses to infect vaccinated people, leading to record-high case numbers across the world as the variant spread, even in highly-vaccinated places like the U.K. But several studies have shown that boosting restores some protection against symptomatic illness and, to a greater degree, against hospitalization.
28th Jan 2022 - The Wall Street Journal

Antibiotic-Resistant Germs Could Be Worse Than Covid

A far more nightmarish catastrophe is already brewing in patients’ bodies, hospitals and other places where deadly microbes gather, writes Therese Raphael. And it’s not just one disease but a microscopic Hydra of bugs, all evolving to become more resistant to lifesaving medicines. These ailments already kill millions each year, a toll that will only grow because the bugs keep evolving while the drugs don’t, partly because making new antibiotics is bad business for Big Pharma. (As you might have heard, this industry came here to chew bubble gum and rack up ludicrous profits, and it’s all out of bubble gum. A new generic-drug venture by Mark Cuban could be a model for pushing drug prices lower, writes Lisa Jarvis, but it’s got a ways to go to make a dent in the industry.)
28th Jan 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Jan 2022

View this newsletter in full

EU drug regulator OKs Pfizer COVID pill for high-risk patients

The European Union's drug regulator on Thursday gave the green light to Pfizer Inc's antiviral COVID-19 pill for treating adults at risk of severe illness, as the region scrambles to boost its arsenal to fight the Omicron variant. The endorsement by the European Medicines Agency (EMA) for a conditional approval, if followed as usual by the European Commission, allows EU member states to deploy the drug after the regulator gave guidance for its emergency use late last year. Italy, Germany and Belgium are among a handful of EU countries that have bought the drug, branded as Paxlovid.
27th Jan 2022 - Reuters

Data reassuring on menstrual changes after Covid-19 vaccine, researchers find

Any menstrual changes after Covid-19 vaccination are short-lived and small compared with natural variation in normal cycles, according to an assessment of the latest evidence published by the British Medical Journal (BMJ). Many women have reported changes to their periods after vaccination. Two new observational studies on the issue provide reassuring data, said Dr Victoria Male, a reproductive specialist at Imperial College London. The first study drew on data from 3,959 Americans who logged at least six consecutive cycles on a tracking app. Of these, 2,403 were vaccinated while the remainder acted as a control group.
27th Jan 2022 - The Irish Times

Vaccination, infection may lower long Covid-19 symptoms: Study

People who have both been vaccinated and had Covid-19 are less likely to report fatigue and other health problems seen post Covid, than unvaccinated people, according to a study based in Israel. The study, not yet peer reviewed, showed that vaccinated people were no more likely to report symptoms than people who have never caught SARS-CoV-2, Nature reported.
27th Jan 2022 - Business Standard

Canadian university races former Chinese partner to make a COVID-19 booster

The federal government has trumpeted previous vaccine partnerships with a China-based company as one of the reasons why Canada was pinning its hopes on a COVID-19 vaccine candidate from China early in the pandemic. But The Fifth Estate has reviewed those partnerships and found that a collaboration with McMaster University in Hamilton stalled years ago and never resulted in an approved vaccine anywhere in the world. That collaboration has been of little benefit to the university or Canada. Instead, both the company, CanSino Biologics, and McMaster are now independently racing to develop similar COVID-19 booster vaccines.
27th Jan 2022 - CBC.ca

Covid-19: Cuba will request WHO approval for homegrown vaccine

Cuban health officials have said that they will apply for World Health Organization approval for one of the country’s homegrown covid-19 vaccines, as they announced that they had secured funding to produce 200 million vaccine doses for low income countries. Cuba’s health regulator (CECMED) has approved the use of three of the country’s homegrown vaccines, which are exported to four countries, but none has been yet been approved by WHO.1 That should change this year, said Rolando Pérez Rodríguez, director of science and innovation at Cuba’s state run pharmaceutical conglomerate, BioCubaFarma. “We have formally requested the prequalification of one vaccine: Abdala,” Rodriguez told a press conference in Havana on 25 January. “We are in the final review of the documents, and it should be sent in the following days to the WHO.” The application for WHO approval of a second Cuban vaccine, Soberana 2, should be sent in the coming weeks and is also expected to gain authorisation for use this year, said Dagmar García Rivera at the Finlay Institute of Vaccines in Havana.
27th Jan 2022 - The BMJ

Covid-19: Lower vaccination rates partly explain higher death rates among minority ethnic groups

Death rates from covid-19 remain higher for most minority ethnic groups compared with people identifying as white British, and some of that disparity is because of their lower uptake of vaccinations, show data from the Office for National Statistics (ONS). Throughout the pandemic covid-19 mortality has been higher in most minority ethnic groups compared with white British people. Vahé Nafilyan, senior statistician at the ONS, said, “As already highlighted in our analyses of earlier periods, these differences in mortality are largely explained by sociodemographic and economic factors and health. For the first time, we show that the lower vaccination coverage in some ethnic groups also contributes to the elevated risk of covid-19 death, particularly in the black African and black Caribbean groups.”
27th Jan 2022 - The BMJ

Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA

Pfizer Inc wants to intervene in a Texas federal lawsuit seeking information from the U.S. Food and Drug Administration used in licensing the company's COVID-19 vaccine, a litigation move that plaintiffs who are suing for the data say is premature. Pfizer's lawyers at DLA Piper told U.S. District Judge Mark Pittman on Jan. 21 it wanted a role in the proceedings to help the FDA avoid "inappropriately" disclosing trade secret and confidential commercial information.
27th Jan 2022 - Reuters

Booster shots could cut Europe's COVID hospitalisations by up to 800000 -EU

Booster shots could reduce future hospitalisations in Europe by at least half a million, the European Union's public health agency said on Thursday, even as the Omicron variant spreads at an unprecedented pace. "The current uptake of a booster dose achieved by early January may reduce future Omicron hospital admissions by 500,000 - 800,000" in Europe, the European Centre for Disease prevention and Control (ECDC) said. The figures cover the 27-nation EU plus Norway, Iceland and Liechtenstein.
27th Jan 2022 - Reuters

Can COVID-19 vaccines help prevent long COVID?

Although most people make a full recovery from a COVID-19 infection, for some the symptoms can last weeks or even months, a condition known as long COVID. According to the World Health Organization (WHO), long COVID is defined as a condition that occurs in “individuals with a history of probable or confirmed SARS CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis”. It is estimated that up to one in 10 people who get infected with SARS-Cov-2 will suffer symptoms of long COVID which may vary from mild to severe. A study carried out by the University of Washington put the incidence of long COVID even higher, showing up to 30 percent of those who tested positive for COVID-19 had symptoms months later
27th Jan 2022 - Al Jazeera English

Pfizer, Moderna shots safe during in vitro fertilization; healthy gut bacteria may help prevent long COVID

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. mRNA vaccines safe during in vitro fertilization. COVID-19 vaccines using mRNA technology do not affect fertility outcomes during in-vitro fertilization (IVF), researchers have found. They compared rates of fertilization, pregnancy, and early miscarriage in IVF patients who had received two doses of the vaccines from Pfizer with BioNTech or Modernaor with those in unvaccinated patients
27th Jan 2022 - Reuters

Moderna starts trial for Omicron-specific booster shot

Moderna Inc said it had started a mid-stage study, testing a booster dose of its COVID-19 vaccine specifically designed to target the Omicron coronavirus variant, a day after rival Pfizer Inc launched a similar trial. The company said while a third shot of its original coronavirus vaccine increased neutralizing antibodies against the variant at the lower dose, their levels declined six months after the booster dose was administered. However, neutralizing antibodies remained detectable in all participants, Moderna said.
27th Jan 2022 - Reuters

Omicron subvariant appears more contagious, but not more severe, Denmark says

The BA.2 subvariant of the Omicron coronavirus variant, which is dominant in Denmark, appears more contagious than the more common BA.1 sub-lineage, Danish Health Minister Magnus Heunicke said on Wednesday in a national address. "There is no evidence that the BA.2 variant causes more disease, but it must be more contagious," Heunicke told a news conference. The BA.1 lineage currently accounts for 98% of all cases globally but in Denmark has been pushed aside by BA.2, which became the dominant strain in the second week of January.
27th Jan 2022 - Reuters

Review: No role for convalescent plasma in most COVID hospital patients

A prospective meta-analysis of international randomized clinical trials (RCTs) of convalescent plasma for the treatment of hospitalized COVID-19 patients finds no clinical benefit in most cases. Convalescent plasma, considered an experimental treatment by the US Food and Drug Administration (FDA), is donated by COVID-19 survivors in the hope that recipients with current infections benefit from the anti–SARS-CoV-2 antibodies. On Dec 28, 2021, the FDA restricted the use of convalescent plasma to patients with impaired immune systems.
27th Jan 2022 - CIDRAP

S. Korea expert defends use of rapid tests as omicron surges

South Korea’s top infectious disease expert defended the move to expand the use of rapid testing despite accuracy concerns, as the country broke its daily coronavirus record for the third straight day. The 14,518 confirmed new cases Thursday were 1,500 more than Wednesday and about double the cases reported on Monday, illustrating a tidal wave of infections driven by the highly contagious omicron variant. The surge, which could continue for weeks, has left health authorities scrambling to reshape the country’s pandemic response, such as treating a larger number of mild cases at home and shortening quarantine periods. Officials are also pushing ahead with a more controversial plan to rewire the testing regime that had been centered around gold standard PCR tests and expand the use of rapid antigen kits that will be made available at public health offices, testing stations and pharmacies
27th Jan 2022 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Jan 2022

View this newsletter in full

Long Covid Symptoms: Scientists Find Potential Factors Linked to Long Covid

Scientists seeking to find out which patients are most at risk of developing long Covid offered partial answers in a study. People who have circulating fragments of the coronavirus, specific antibodies directed against their own tissues or organs -- known as auto-antibodies -- and a resurgence of the Epstein-Barr virus appear more at risk, researchers said in an article in the scientific journal Cell. Scientists are racing to better understand and predict long Covid, in which patients still confront a wide range of health problems months after recovery. The team of more than 50 researchers found some markers that could be identified early and appeared to correlate with lasting symptoms, regardless of whether the initial infection was severe.
26th Jan 2022 - Bloomberg

Wanted: Volunteers to catch COVID in the name of science

The world's first medical trial authorised to deliberately expose participants to the coronavirus is seeking more volunteers as it steps up efforts to help develop better vaccines. The Oxford University trial was launched last April, three months after Britain became the first country to approve what are known as challenge trials for humans involving COVID-19. Its first phase, still ongoing, has focused on finding out how much of the virus is needed to trigger an infection while the second will aim to determine the immune response needed to ward one off, the university said in a statement on Tuesday.
26th Jan 2022 - Reuters

Coronavirus vaccines may reduce risk of long Covid, ONS study finds

The study, of more than 6,000 adults, found those who were double-vaccinated had a 41% lower likelihood of self-reporting Covid symptoms 12 weeks after first testing positive. Overall, 9.5% of the double-vaccinated group reported experiencing long Covid, defined as symptoms lasting more than four weeks, compared with 14.6% of a socio-demographically matched group who were unvaccinated. Dr David Strain, a clinical senior lecturer at the University of Exeter medical school and the British Medical Association’s lead on long Covid, said the ONS findings fitted with research published this week that showed low levels of certain antibodies were more common in those who developed long Covid than in patients who swiftly recovered.
26th Jan 2022 - The Guardian

COVID-19: Spike in Omicron cases in children could lead to another surge in adults, scientists suggest

The return to school is driving up Omicron infections in children and could lead to another surge in adults, scientists have warned. The latest results from the REACT-1 study, which is based on around 100,000 random tests across England, show that the infection rate in primary school-age children was 7.8% - and rising - during the study period of 5 to 20 January. By contrast infection rates in adults were far lower and falling, with people over 75 least likely to have COVID at 2.4%.
26th Jan 2022 - Sky News

Two thirds of Omicron cases previously had Covid-19, study finds

Around two thirds of people who have been infected with the Omicron variant had already had Covid-19. New data underlines the ability of the now-dominant strain to evade the immune response generated by prior infection. The study also estimates that an unprecedented one in 23 people were infected with the coronavirus in January. A huge surge of infections, which saw the daily count hit a new record of more than 200,000, meant the prevalence in the general population between January 5 and 20 (4.41%) was higher than at any point since March 2020.
26th Jan 2022 - Metro

COVID is less severe with Omicron than Delta, U.S. study suggests

The Omicron variant appears to result in less severe COVID-19 than seen during previous periods of high coronavirus transmission including the Delta wave, with shorter hospital stays, less need for intensive care and fewer deaths, according to a new U.S. study. However, the fast-spreading Omicron variant has led to record numbers of infections and hospitalizations, straining the U.S. healthcare system.
26th Jan 2022 - Reuters

75% of COVID ICU survivors have physical symptoms 1 year on

One year after 246 COVID-19 survivors were treated in 1 of 11 intensive care units (ICUs) in the Netherlands, nearly 75% reported lingering physical symptoms, more than 26% said they had mental symptoms, and upwards of 16% still had cognitive symptoms, according to a study yesterday in JAMA. The prospective study was conducted among 246 patients 16 years and older admitted to an ICU from Mar 1 to Jul 1, 2020, and followed up to Jun 16, 2021. Average participant age was 61.2 years, 71.5% were men, average body mass index was 28.0 kg/m2 (overweight), and average ICU stay was 18.5 days. The research team surveyed participants about physical symptoms using the Clinical Frailty Scale, fatigue using the Checklist Individual Strength, mental symptoms using the Hospital Anxiety and Depression Scale, posttraumatic stress disorder (PTSD) using the Impact of Event Scale, and cognitive symptoms using the Cognitive Failures Questionnaire-14 (score of 43 and up indicating cognitive symptoms).
26th Jan 2022 - CIDRAP

Why Hong Kong may become a living laboratory in search for Covid-19 answers

In the two months since it first hit the world’s Covid-19 radar, scientists have generated an astonishing amount of information on the Omicron variant. Still, key questions remain about Omicron, as well as about a new subvariant, known as BA.2. Among them: How much more transmissible is BA.2 than its wildly transmissible parent? Answering questions like these can be challenging, sometimes almost impossible, in many locations because such a large proportion of people has been vaccinated, previously infected, or both. That can make it hard to tease out whether certain outcomes are attributable to changes in the virus versus the result of built-up human immunity. But it turns out there is a place where clear answers to key questions may be within reach — if that place is really, really unlucky.
26th Jan 2022 - STAT News

'Nocebo' effect may account for 76% of COVID-19 vaccine side effects

When placebos elicit adverse events, these are often called nocebo responses. A study finds that a third of people who received placebos during COVID-19 vaccine clinical trials reported unpleasant systemic side effects such as headache and fatigue. The authors of the study find that 76% of side effects reported by actual vaccine recipients are likely the same effects and attributable to nocebo responses.
25th Jan 2022 - Medical News Today

Heterologous vaccine schedule provides extraordinary response to third dose of coronavirus vaccines

A third, booster dose of either the ChAdOx1 nCoV-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer-BioNTech), AD26.COV2-S (Janssen) or CoronaVac (SinoVac) coronavirus vaccine induce a significant increase in antibody levels in those who have previously received two doses of CoronaVac. The strongest responses were seen with mixed schedules, including against the Delta and Omicron variants of concern. The results from a study funded by the Ministry of Health, Brazil, and conducted by researchers from Brazil and the University of Oxford have today been published as a peer-reviewed paper in the Lancet.
25th Jan 2022 - News-Medical.Net

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Jan 2022

View this newsletter in full

Pfizer Begins Study Testing Omicron Vaccine in People

Pfizer Inc. and BioNTech SE have started a trial evaluating an adapted version of their Covid-19 vaccine that targets the Omicron variant of the coronavirus. The drugmakers said Tuesday they began enrolling adults ages 18 to 55 in the U.S. and South Africa to examine the safety, tolerability and immune response generated by the vaccine if it is given either as a primary series or as a booster dose. One subject has already received the shot, Pfizer said. Initial study results are expected in the first half of the year, Pfizer said. The drugmaker could ask U.S. regulators for authorization and begin distribution in March, should the Omicron-targeted shot prove to work safely, Chief Executive Albert Bourla has said. Should the vaccine be needed, Pfizer and BioNTech would still be able to manufacture 4 billion doses of the shot this year, the companies said.
25th Jan 2022 - The Wall Street Journal

Novavax Covid-19 vaccine to be rolled out in Australia from next month

Australia’s health minister has announced that Novavax’s Covid-19 vaccine will be rolled out across the country from February 21. The news comes just days after the Australian drugs regulator Therapeutic Goods Administration (TGA) provisionally approved the jab,
25th Jan 2022 - Pharmaceutical Technology

Pfizer and BioNTech maintain production estimates of 4 billion COVID-19 vaccine doses in 2022

Pfizer and BioNTech expect to produce four billion doses of their COVID-19 vaccine in 2022: regardless of whether the current vaccine or a new Omicron specific vaccine is needed.
25th Jan 2022 - BioPharma-Reporter

Israeli panel recommends fourth Covid vaccine dose for all adults

Israel’s vaccine advisory panel has recommended a fourth dose of a Covid-19 shot for all adults, a world first, as the country battles a surge in infections driven by the Omicron coronavirus variant. The move follows research showing fourth doses doubled protection against symptomatic Covid-19 and increased protection against severe illness by three to five times, compared with three doses. Other countries, including the UK, US and Chile, have signed off on fourth doses for immunocompromised people, such as those living with HIV or certain transplant recipients, but have hesitated on launching a widescale second booster campaign.
25th Jan 2022 - Financial Times

Getting infected after getting Covid triggers 'super-immunity'

People who have been vaccinated and catch Covid have 'super immunity' Infection and vaccination in any order results in 10-times more Covid antibodies Findings suggest virus will become 'mostly mild' and bring about end of crisis
25th Jan 2022 - Daily Mail

Covid-19: CoronaVac immunity is strongest after boosting with a different vaccine

A booster dose of a covid-19 jab other than CoronaVac significantly increased antibodies in those who had received two doses of the Chinese vaccine, a study funded by Brazil's Ministry of Health has found. A booster dose of Pfizer Biontech’s mRNA vaccine boosted antibody levels the most, followed by Oxford AstraZeneca, Janssen, and a third dose of CoronaVac. All booster vaccines were effective and safe, concluded the researchers at the University of Oxford, who co-led the study published in the Lancet. The findings will guide governments on how to boost their populations’ immunity in the face of the more infectious omicron variant. CoronaVac is manufactured by Chinese pharmaceutical Sinovac and is the world’s most administered coronavirus vaccine, making up two of the 10 billion vaccine doses given globally. A preprint study has found CoronaVac to be less effective than mRNA vaccines and that its effectiveness drops further against omicron,2 so the findings are a boost for the many countries in Africa, Latin America, and South-east Asia that rely on the vaccine.
25th Jan 2022 - The BMJ

Covid-19: Europe could be headed for pandemic “endgame,” says WHO region chief

The rapid spread of the omicron variant of SARS-CoV-2 could see an end to the pandemic in Europe, with the variant likely to have infected 60% of people on the continent by March, the World Health Organization’s regional director for Europe has said. “It’s plausible that the region is moving towards a kind of pandemic endgame,” Hans Kluge told Agence France-Presse on 23 January. Once the current wave subsides, he said, “there will be for some weeks and months a global immunity, either thanks to the vaccine or because people have immunity because of the infection, and also lowering seasonal risk.” “We anticipate that there will be a period of quiet before covid-19 may come back towards the end of the year, but not necessarily the pandemic coming back,” Kluge said.
25th Jan 2022 - The BMJ

BioNTech/Pfizer launch Omicron COVID-19 vaccine clinical trial

BioNTech/Pfizer have launched a study of a new coronavirus vaccine that targets the Omicron variant — the first retooled version of an EU-approved vaccine to begin clinical testing. As Omicron sweeps across Europe and the world, fast becoming the dominant strain in many countries, medicines regulators and public health bodies are in talks over whether existing vaccines provide enough protection. Omicron can dodge much of the defenses offered by a standard course of COVID-19 vaccines, especially as the immune response wanes. While boosting with the Wuhan-strain of vaccines has shown to protect against severe disease from Omicron, most recent data suggests that even this protection starts to wane as well. COVID-19 vaccine-makers have rushed to develop vaccines that specifically target Omicron, which was first detected in southern Africa in November. While a global decision has not yet been taken on the composition of the next-generation of COVID-19 vaccines, medicines regulators have said revamped COVID-19 jabs need to be tested in clinical trials to demonstrate what immune response they generate.
25th Jan 2022 - POLITICO Europe

Chile to purchase 2 million Moderna COVID-19 vaccine doses

Chile, which already boasts one of the world's highest COVID-19 vaccination rates, has agreed to purchase 2 million vaccine doses from Moderna Inc, Chilean interim health minister Maria Teresa Valenzuela said on Monday. Chile has been hailed as a model for its response to the pandemic, relying mainly on vaccines from Pfizer-BioNTech, Sinovac and AstraZeneca for its inoculation program. "The agreement with Moderna is subject to approval by the Institute of Public Health, which will review the information on safety and efficacy in the coming weeks," said Valenzuela.
25th Jan 2022 - Reuters

European Medicines Agency panel approves scaling up AstraZeneca COVID vaccine production

A panel of the European drug regulator on Monday approved scaling up manufacturing of AstraZeneca's (AZN.L) COVID-19 vaccine. An existing manufacturing site operated by Universal Farma in Guadalajara, Spain, will add a second filling line for the vaccine, the European Medicines Agency's human medicines committee said in a statement. The scaling up is expected to support the continued supply of the vaccine, including for donations to third countries through COVAX.
25th Jan 2022 - Reuters

Germany to receive 3.8 mln doses of Novavax's new COVID vaccine in Q1

Germany expects to receive 3.8 million doses of Novavax's newly approved COVID-19 vaccine Nuvaxovid by March 20, the health ministry said on Tuesday, as the government looks to persuade unvaccinated Germans to get a shot. Germany will receive 1.4 million doses in the week of Feb. 21 and should receive the rest of the 3.8 million doses in the subsequent few weeks. Novavax is expected to deliver 34 million doses to Germany this year. The shipment is a part of the U.S. drugmaker's deal to supply up to 200 million doses to the European Union's 27 member states.
25th Jan 2022 - Reuters

Does the world need more COVID-19 vaccines? These companies think there's still room for improvement

The ultimate COVID-19 vaccine will be able to tackle all emerging coronavirus strains, easy to store and quick to manufacture. And yes, there's still time for the stragglers who were beaten to the punch by Pfizer, BioNTech and Moderna—at least according to the companies still trying to get in line. Not to mention, just 60% of the world has been vaccinated, according to the University of Oxford’s Our World in Data database. The rates are higher in richer regions like the U.S. and EU, while the need is great in less developed nations. But the window to contribute to the vaccine fight is closing. A new report from Morningstar sees demand for boosters remaining heavy in 2022 but dissipating over 2023. If a company isn't already filing for authorization, they'd better get on it. Jean-Francois Toussaint, Ph.D., head of research and development for Sanofi Pasteur, said 20 billion doses of existing vaccines are expected to be available this year. So where does that leave remaining companies, like Toussaint’s, that have shots in the pipeline?
24th Jan 2022 - FierceBiotech

‘Nocebo effect’: two-thirds of Covid jab reactions not caused by vaccine, study suggests

More than two-thirds of the common side-effects people experience after a Covid jab can be attributed to a negative version of the placebo effect rather than the vaccine itself, researchers claim. Scientists in the US examined data from 12 clinical trials of Covid vaccines and found that the “nocebo effect” accounted for about 76% of all common adverse reactions after the first dose and nearly 52% after the second dose. The findings suggest that a substantial proportion of milder side-effects, such as headaches, short-term fatigue, and arm pain are not produced by the constituents of the vaccine, but by other factors thought to generate the nocebo response, including anxiety, expectation and misattributing various ailments to having had the jab.
18th Jan 2022 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Jan 2022

View this newsletter in full

Increase in the Incidence of type 1 diabetes in children during the Covid-19 pandemic

During the COVID-19 pandemic, more children and adolescents newly developed type 1 diabetes than in previous years. This is shown by a recent study of the DZD, the University of Giessen and the University of Ulm with co-authors from other centers in Germany, based on the data of the multicenter German Diabetes Prospective Follow-up Registry (DPV*). The aim of this study was to investigate the incidence of type 1 diabetes in children and adolescents during the COVID-19 pandemic in Germany in comparison to previous years. For this purpose, the researchers recorded the children and adolescents aged between six months and under 18 years newly diagnosed in Germany for the period from January 1, 2020 to June 30, 2021
24th Jan 2022 - EurekAlert!

‘Stealth Omicron’: Everything we know about new ‘under investigation’ Covid-19 strain BA.2

Health chiefs have revealed they are officially monitoring a new version of Covid-19 – which has been nicknamed “stealth Omicron”. The UK Health Security Agency has marked BA.2 a “variant under investigation” – one level below a “variant of concern” – after early data suggested it may be both more transmissible and better able to evade vaccines than previous strains of the killer virus. It is a sub-lineage of the original Omicron – BA.1 – but appears to have certain differences that may make it both faster at spreading and harder to detect. According to the World Health Organisation, it is now probably outpacing the earlier strain with some 8,000 cases identified in more than 40 countries, including the US, India, Germany and Australia.
24th Jan 2022 - The Independent

EU regulator set to rule on Pfizer COVID pill by end-Jan, ahead of Merck - source

The European Union's drug regulator is set to decide whether to approve Pfizer's COVID-19 pill at the end of this month, before doing a final review of Merck's similar but less effective drug in February, a source with knowledge of the matter said. Late last year, the European Medicines Agency (EMA) gave guidance to member states on how to use both antiviral pills as emergency treatments, while it carried out rolling reviews to help member states decide on quick adoption ahead of any formal EU-wide approval
24th Jan 2022 - Reuters

UK to begin testing Merck's COVID pill for hospitalised patients

British scientists will begin testing Merck (MRK.N) and Ridgeback Biotherapeutics' antiviral pill molnupiravir as a possible treatment for patients hospitalised with COVID-19, amid the worldwide spread of the Omicron variant. The pill is approved in Britain for use in people with mild to moderate COVID-19, but it is not known whether it would work in patients hospitalised with severe illness, researchers of the RECOVERY trial said on Monday. The study will compare 800 mg doses of molnupiravir, given twice daily for five days, with standard care for adult patients in hospitals because of COVID-19.
24th Jan 2022 - Reuters

WHO chief says world at 'critical juncture' in COVID pandemic

The head of the World Health Organization (WHO) warned on Monday that it was dangerous to assume the Omicron variant would herald the end of COVID-19's acutest phase, exhorting nations to stay focused to beat the pandemic. "It’s dangerous to assume that Omicron will be the last variant and that we are in the end game," Tedros Adhanom Ghebreyesus told a WHO executive board meeting of the two-year pandemic that has killed nearly 6 million people. "On the contrary, globally the conditions are ideal for more variants to emerge."
24th Jan 2022 - Reuters

Fourth COVID vaccine shot raises resistance to serious illness for over-60s: Israel

A fourth dose of COVID-19 vaccine given to people over 60 in Israel made them three times more resistant to serious illness than thrice-vaccinated people in the same age group, Israel's Health Ministry said on Sunday. The ministry also said the fourth dose, or second booster, made people over 60 twice as resistant to infection than those in the age group who received three shots of the vaccine. A preliminary study published by Israel's Sheba medical centre last Monday found that the fourth shot increases antibodies to even higher levels than the third but "probably" not to the point that it could completely fend off the highly transmissible Omicron variant.
24th Jan 2022 - Reuters

Omicron ‘sub-variant’ throws up new virus questions

Scientists are keeping a close watch on a recently-discovered sub-variant of the Omicron variant of the coronavirus to determine how its emergence could affect future pandemic spread. The initial Omicron variant has become the dominant virus strain in recent months but British health authorities have notably identified hundreds of cases of the latest version, dubbed BA.2, while international data suggest it could spread relatively quickly.
24th Jan 2022 - Al Jazeera English

Europe could be headed for pandemic 'endgame': WHO

The Omicron variant has moved the Covid-19 pandemic into a new phase and could bring it to an end in Europe, the WHO Europe director said Sunday. "It's plausible that the region is moving towards a kind of pandemic endgame," Hans Kluge told AFP in an interview, adding that Omicron could infect 60 percent of Europeans by March. Once the current surge of Omicron sweeping across Europe subsides, "there will be for quite some weeks and months a global immunity, either thanks to the vaccine or because people have immunity due to the infection, and also lowering seasonality". "We anticipate that there will be a period of quiet before Covid-19 may come back towards the end of the year, but not necessarily the pandemic coming back," Kluge said. Top US scientist Anthony Fauci expressed similar optimism on Sunday, telling ABC News talk show "This Week" that with Covid-19 cases coming down "rather sharply" in parts of the United States, "things are looking good".
24th Jan 2022 - IBTimes UK

WHO chief warns against talk of ‘endgame’ in pandemic

The World Health Organization’s director-general on Monday warned that conditions remain ideal for more coronavirus variants to emerge and it’s dangerous to assume omicron is the last one or that “we are in the endgame.” But Tedros Adhanom Ghebreyesus said the acute phase of the pandemic could still end this year if some key targets are met. Tedros laid out an array of achievements and concerns in global health over issues like reducing tobacco use, fighting resistance to anti-microbial treatments, and risks of climate change on human health. But he said “ending the acute phase of the pandemic must remain our collective priority.”
24th Jan 2022 - The Associated Press

Researchers find genetic link to COVID-19-induced loss of smell and taste

A new study suggests there is a genetic factor that increases the odds of someone losing their sense of smell or taste after getting COVID-19. Researchers analyzed data from close to 70,000 people for the study. Although more research is needed, the study’s findings might help scientists better understand why some people who contract the virus lose one or both senses.
23rd Jan 2022 - The Hill

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Jan 2022

View this newsletter in full

UK health chiefs are now officially keeping tabs on 'stealth' version of Omicron

UK Health Security Agency has classed BA.2 as a 'variant under investigation' It means BA.2 is spreading in the UK and may be more infectious or jab resistant But scientists say it likely will not have a 'substantial impact' on the current wave
22nd Jan 2022 - Daily Mail

As Covid-19 Pills Roll Out, Worry Mounts That Resistance Could Develop

Researchers and U.S. health regulators worry Covid-19 will figure out a way to evade important new pills, prompting efforts to look for signs of such resistance and find combinations to thwart it. The treatments—Paxlovid from Pfizer Inc. and molnupiravir from Merck & Co. and Ridgeback Biotherapeutics LP—are the first drugs authorized by federal health regulators that people early in the course of an infection can easily take at home to avoid severe disease. Yet viruses are notorious for mutating in ways that allow them to bypass antivirals, especially when the drugs are given alone as is the case with the new Covid-19 pills. That is why treatments for other viruses such as HIV and hepatitis C consist of multiple drugs. Combinations cut the risk of resistance resulting from mutations because a virus is forced to do more to survive.
22nd Jan 2022 - The Wall Street Journal

GlaxoSmithKline Racing to Provide Only Effective Covid-19 Antibody Treatment

GlaxoSmithKline PLC and partner Vir Biotechnology Inc. are straining to meet soaring demand for their Covid-19 antibody treatment after the highly mutated Omicron variant knocked out the two competing products. Demand has jumped in recent weeks for the treatment, called sotrovimab, because it is the only antibody drug authorized in the U.S. for the newly infected that has been found to work against Omicron. Glaxo and Vir, which were using one manufacturing plant, say they have raced to add another and taken other steps to roughly double the number of doses they can deliver to the U.S. in the first quarter to 600,000.
22nd Jan 2022 - The Wall Street Journal

Third Dose of Pfizer, Moderna Covid-19 Vaccines Offers Strong Protection Against Omicron

Vaccines and booster shots offer superior protection from the Delta and Omicron variants, according to three new studies released by the Centers for Disease Control and Prevention. The data back up earlier findings supporting booster shots and offer the first comprehensive insight into how vaccines fare against the Omicron variant. In one of the studies published Friday, a CDC analysis found that a third dose of either the vaccine from Pfizer Inc. and BioNTech SE or Moderna Inc. was at least 90% effective against preventing hospitalization from Covid-19 during both the Delta and Omicron periods.
22nd Jan 2022 - The Wall Street Journal

Mixing Sinovac With Different Boosters Increases Protection

People who had two doses of the Covid-19 vaccine made by China’s Sinovac Biotech Ltd. should get boosted with a different shot to amp up their protection against omicron, according to a study by researchers from Brazil and the University of Oxford. The research, published Friday in The Lancet, tested booster combinations on 1,240 people from Brazil above 18 years old who had been immunized with Sinovac’s shot, one of the most widely used globally, six months prior. While those who received a third Sinovac dose did experience a boost in antibodies 28 days later, the level of improvement was found to be much higher in people who were boosted with vaccines from Pfizer Inc., AstraZeneca Plc, or Johnson & Johnson.
22nd Jan 2022 - Bloomberg

Omicron Reinfections Unlikely Over Several Months, Fauci Says

It’s extremely unlikely that a person can be reinfected with omicron, at least in the short-term, President Joe Biden’s top medical adviser said, as the U.S. begins to see sharp declines in cases in places hit earliest by the variant. “There are reinfections, but it is unlikely that -- if you mounted a good immune response -- at least over a period of several months, it is extremely unlikely that you will be reinfected with the same variant,” Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a press briefing on Friday. Cases of reinfection have typically been in people who fell ill with one variant and then later contracted a different variant, Fauci said.
22nd Jan 2022 - Bloomberg

U.S. studies highlight the need for COVID boosters to fight Omicron

Three U.S. studies show that a third dose of an mRNA vaccine is key to fighting the Omicron coronavirus variant, providing 90% protection against hospitalization due to COVID-19, the U.S. Centers for Disease Control and Prevention (CDC) said on Friday. The studies, led by the CDC, are among the first in the United States to look at the impact of booster doses against the fast-spreading Omicron variant, which now accounts for 99% of all new COVID cases. Overall, they suggest that boosters helped protect against both infection and symptomatic disease
22nd Jan 2022 - Reuters

EU health ministers seek common line over fourth COVID vaccine dose

European Union health ministers were told on Friday to prepare to deploy a fourth dose of COVID-19 vaccines as soon as data showed it was needed, as the bloc faces a surge in cases of the Omicron variant of the coronavirus. The EU drugs regulator said this week it would be reasonable to give a fourth dose to people with severely weakened immune systems, but more evidence was needed. "If we see data which is conclusive on whether a fourth dose is needed, we need to be ready to act," EU Health Commissioner Stella Kyriakides told EU ministers in a video conference, her speaking points showed.
21st Jan 2022 - Reuters

Japan approves Pfizer COVID vaccine for children aged 5 to 11 -

Japan’s health ministry has authorised the use of Pfizer and BioNTech COVID-19 vaccine in children aged between five and 11. The vaccine, Comirnaty, is claimed to be the first in Japan to be approved for use in this age group. Once the Ministry of Health, Labor and Welfare grants special approval, Japan will join the UK and US in efforts to reduce the impact of COVID-19 in children. Until now, the mRNA vaccine has only been available to individuals over the age of 12 in the country. However, with this approval, approximately seven million children will be eligible to receive a dose of the vaccine. According to ministry officials, inoculations could begin as early as March once specific details of the roll-out are finalised.
21st Jan 2022 - Pharmaphorum

No evidence coronavirus vaccines cause infertility, study finds

Florida Gov. Ron DeSantis (R), a foe of vaccine mandates, appeared to suggest Thursday that getting a shot to protect against the coronavirus could cause infertility. “Think about how ridiculous it is what they’re doing by trying to force the nurses” to get immunized, he said in a speech announcing funding for nursing certification programs. “A lot of these nurses have had covid. A lot of them are younger. Some of them are trying to have families.” But there is no evidence that getting vaccinated against the coronavirus makes it harder to conceive, according to a study released Thursday of heterosexual couples trying for pregnancy. DeSantis could not be immediately reached for a comment on his remarks. By contrast, men infected with the coronavirus showed signs of a short-term decline in fertility, according to the research, which was led by an epidemiologist at Boston University and published in the peer-reviewed American Journal of Epidemiology. It was funded by the National Institutes of Health.
21st Jan 2022 - The Washington Post

Covid-19 vaccine mixing: could heterologous boosters improve immunity?

As the world grappled with vaccinating against Covid-19 last year, a mix-and-match approach to jabs emerged as a potential solution to roadblocks like vaccine hesitancy, safety concerns, and supply chain issues. In the months since, numerous studies have shown that administering different Covid-19 vaccines for the first and second doses induces a strong immune response against the novel coronavirus, and recent research has even suggested that mixing jabs is more effective than administering two doses of the same vaccine. Now, with vaccine booster programmes underway across the globe, the next question is whether this mix-and-match rule applies to booster doses. More than 36 million booster doses have been administered in the UK so far, while over 62 million people in the US have received a third shot
21st Jan 2022 - Pharmaceutical Technology

GlaxoSmithKline Racing to Provide Only Effective Covid-19 Antibody Treatment

Singapore approves COVID-19 vaccine boosters for age 12-17s

Singapore will extend its COVID-19 booster vaccination programme to adolescents aged 12 to 17 years from next month, its health ministry said on Friday. Singapore is among the first few countries to recommend boosters for that age group, following Germany, the United States, Israel and Hungary.
21st Jan 2022 - Reuters

Pfizer says has approval in Japan for COVID vaccine for children aged 5-11

Pfizer Inc said it received special approval in Japan for its COVID-19 vaccine to be given to children aged 5-11. The mRNA-type vaccine developed by Pfizer and BioNTech SE has been the most commonly used in Japan for protection against the coronavirus so far.
21st Jan 2022 - Reuters

WHO recommends reduced dose Pfizer COVID vaccine for under 12s

The World Health Organization on Friday recommended extending the use of a reduced dosage of Pfizer's (PFE.N) COVID-19 vaccine to children aged 5 to 11 years old. The recommendation comes after the Strategic Advisory Group of Experts (SAGE) on immunisation held a meeting on Wednesday to evaluate the vaccine. It is currently recommended for use in people aged 12 years and above. The recommended dosage for the younger population is 10 micrograms instead of 30 micrograms offered to those 12 years and older. "This age group (5-11) is in the lowest priority use group for vaccination except, for children who have co-morbidities," SAGE chairman Alejandro Cravioto said at a briefing.
21st Jan 2022 - Reuters

Omicron 'sub-lineage' BA.2 designated as COVID variant under investigation, says UKHSA

The BA.2 form of Omicron has taken hold in countries such as Denmark but so far there doesn't appear too much cause for concern, with experts believing vaccines are effective and hospitalisation levels apparently unchanged. However, there is a possibility it might be more transmissible. The UK Health Security Agency has designated the Omicron variant sub-lineage, known as BA.2, as a variant under investigation - but current case rates are very low. Just 53 sequences had been identified in the UK by 10 January, according to the UKHSA, which said it was doing further analysis. Initial studies from Denmark - where it's quickly taken hold and now makes up around half of Omicron cases - show no difference in hospitalisations between 'original' Omicron and BA.2.
21st Jan 2022 - Sky News

UK designates Omicron sub-lineage a variant under investigation

The UK Health Security Agency on Friday designated a sub-lineage of the dominant and highly transmissible Omicron coronavirus variant as a variant under investigation, saying it could have a growth advantage. BA.2, which does not have the specific mutation seen with Omicron that can help to easily distinguish it from Delta, is being investigated but has not been designated a variant of concern. "It is the nature of viruses to evolve and mutate, so it's to be expected that we will continue to see new variants emerge," Dr Meera Chand, incident director at the UKHSA, said.
21st Jan 2022 - Reuters

Boosters Effectively Fend Off Delta, Omicron Variants in Studies

Booster doses of Covid-19 vaccines increased protection against both the delta and omicron variants in three studies that looked at infections, hospital admissions and deaths in thousands of U.S. patients. Third doses of messenger RNA vaccines made by Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE were at least 90% effective in preventing hospitalizations during both the delta and omicron periods, according to an analysis of hundreds of thousands of hospitalizations and clinic visits.
21st Jan 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Jan 2022

View this newsletter in full

COVID-19: New 'game-changing' X-ray technology developed which can detect coronavirus in minutes

Experts in Scotland have developed groundbreaking Artificial Intelligence (AI) technology which is capable of accurately diagnosing COVID-19 in just a few minutes, much quicker than a PCR test. The research, by the University of the West of Scotland (UWS), uses X-ray technology, comparing scans to a database of around 3,000 images, belonging to patients with COVID- 19, healthy individuals and people with viral pneumonia. It then uses an AI process, an algorithm typically used to analyse visual imagery, to make a diagnosis.
20th Jan 2022 - Sky News

Swiss researchers launch trial for COVID "patch" vaccine

Swiss medical researchers said on Wednesday they have launched an early-stage study to test a next-generation COVID-19 vaccine candidate which would be administered via an arm patch, the latest to look at alternative methods of giving injections. Unlike conventional vaccines that stimulate antibody production, the new PepGNP-Covid19 vaccine candidate focuses on T-cells, which are responsible for cellular immunity, to eliminate cells infected by the virus and prevent it from replicating.
20th Jan 2022 - Reuters

Valneva says early studies show COVID-19 vaccine effective against Omicron

French biotech firm Valneva said that preliminary studies showed that three doses of its inactivated COVID-19 vaccine candidate neutralised the Omicron variant of the disease. All of the serum samples tested presented neutralizing antibodies against the ancestral virus and Delta variant, it said, while 87% of samples did so against the Omicron variant. "We are extremely pleased with these results," said Chief Medical Officer Juan Carlos Jaramillo in a statement, noting that these added to an earlier Phase III trial that showed improved immune response with two doses of the VLA2001 candidate.
20th Jan 2022 - Reuters

Analysis: How Omicron highlights fading hope of herd immunity from COVID

The Omicron variant, which is spreading far faster than previous versions of the coronavirus, is not likely to help countries achieve so-called herd immunity against COVID-19, in which enough people become immune to the virus that it can no longer spread, leading disease experts say. From the earliest days of the pandemic, public health officials have expressed hope that it was possible to achieve herd immunity against COVID-19, as long as a high enough percentage of the population was vaccinated or infected with the virus.
20th Jan 2022 - Reuters

Pfizer CEO awarded $1M Genesis Prize for developing COVID vaccine

Albert Bourla, chairman and CEO of Pfizer, has been awarded the 2022 Genesis Prize for his “leadership, determination and especially for his willingness to assume great risks” in developing a coronavirus vaccine in record time. The Genesis Foundation recognises individuals for their contribution to humanity and commitment to Jewish values.
20th Jan 2022 - Al Jazeera English

Novavax becomes Australia’s 5th approved COVID-19 vaccine

Novavax’s COVID-19 vaccine on Thursday became the fifth coronavirus vaccine approved for use in Australia. The country has ordered 51 million doses of the U.S.-manufactured vaccine, supplied under the brand Nuvaxovid, for its population of 26 million. Pfizer, AstraZeneca and Moderna vaccines are already in use in Australia. Johnson and Johnson’s Janssen vaccine is also approved but the government has not bought any. The Novavax vaccine will be available to unvaccinated Australians aged 18 years and older but will not be used as a booster for the 95% of the population aged 16 and older who have already received a vaccine. “There are some individuals, notwithstanding a massive take up of vaccination in this country, who have been waiting for Novavax, and it’s great that it’s finally been approved,” said chief regulator John Skerritt, head of the Therapeutic Goods Administration.
20th Jan 2022 - The Associated Press

Prior Covid-19 Infection Offered Better Protection Than Vaccination During Delta Wave

Surviving a previous infection provided better protection than vaccination against Covid-19 during the Delta wave, federal health authorities said, citing research showing that both the shots and recovery from the virus provided significant defense. The Centers for Disease Control and Prevention said Wednesday that data from 1.1 million Covid-19 cases in California and New York last year showed people who were unvaccinated and hadn’t previously contracted Covid-19 faced a far greater risk than both people who had gotten the shots and people who had been infected. The data on testing, cases and immunization was collected between May and November, as the Delta variant emerged and became dominant in the U.S., before the more-infectious Omicron variant began to spread widely. The hospitalization data came from more than 50,000 people in just California.
20th Jan 2022 - The Wall Street Journal

Drugmakers Sign Pacts to Widen Access to Merck's Covid Pill

More than two dozen generic-drug manufacturers have agreed to produce low-cost versions of Merck & Co.’s Covid-19 pill, a key step in bringing virus-fighting tools to lower-income countries that have struggled to get vaccines. Companies in Bangladesh, China, India, Kenya, South Africa, Vietnam and other countries signed pacts to supply more than 100 low- and middle-income nations, the United Nations-backed Medicines Patent Pool said Thursday.
20th Jan 2022 - Bloomberg

Cheap version of Merck COVID pill to be made for poorer nations

Nearly 30 generic drugmakers in Asia, Africa and the Middle East will make cheap versions of Merck & Co's COVID-19 pill, under a landmark U.N.-backed deal to give poorer nations wider access to a drug seen as a weapon in fighting the pandemic. Merck's early greenlight to production of its anti-viral pill molnupiravir by other companies during the pandemic is a rare example in the pharmaceutical sector, which usually protects its patented treatments for longer periods.
20th Jan 2022 - Reuters

Waiting for Novavax? The company hopes to vaccinate 1 million unjabbed Australians

Hundreds of thousands of vaccine-hesitant Australians can now choose another jab with Novavax chief commercial officer John Trizzino hoping the newly approved protein-based vaccine could persuade the 5 per cent of the nation yet to be vaccinated. Australia has one of the highest vaccination rates in the world but a persistent group has been “waiting for Novavax” rather than taking the Pfizer or Moderna mRNA vaccines, or the AstraZeneca doses.
20th Jan 2022 - Sydney Morning Herald

Game recognizes game—Lilly, Novartis execs commend Pfizer on Paxlovid, but where does that leave them in the COVID market?

It’s not often that high profile pharmaceutical executives publicly laud a direct competitor’s medicine, but that’s what’s happening these days for Pfizer’s COVID-19 antiviral Paxlovid. “The Pfizer compound was developed kind of from whole cloth during the course of the pandemic,” said Eli Lilly CEO David Ricks, during an interview for Fierce JPM Week. “Small molecule drug development is a tricky business, and it involves as much art as science sometimes, so hats off to them.” That sentiment was echoed by Jay Bradner, M.D., president of the Novartis Institutes for BioMedical Research, the Swiss pharma's R&D engine. “The Pfizer medicine is a remarkable contribution,” Bradner said. “I mean, to take an inhibitor designed for a completely different virus, and then boost what is a peptide-like inhibitor … with a second drug to prevent its disposal, I think it's a pretty heroic act of repurposing, and the activity of the molecule is quite breathtaking.”
20th Jan 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Jan 2022

View this newsletter in full

Merck-Ridgeback to supply courses of Covid-19 oral antiviral to UNICEF

Merck (MSD) and Ridgeback Biotherapeutics have entered a supply agreement with the United Nations Children’s Fund (UNICEF) to aid in wider worldwide access for investigational oral antiviral, molnupiravir, for Covid-19. According to the long-term deal, Merck will allocate up to three million courses of the oral antiviral to UNICEF for supply in over 100 low and middle-income nations during the first half of this year on obtaining regulatory authorisations.
19th Jan 2022 - Pharmaceutical Technology

WHO says no evidence healthy children, adolescents need COVID-19 boosters

There is no evidence at present that healthy children and adolescents need booster doses of COVID-19 vaccine, the World Health Organization's chief scientist Soumya Swaminathan said on Tuesday. Speaking at a news briefing, she said that while there seems to be some waning of vaccine immunity over time against the rapidly spreading Omicron variant of the coronavirus, more research needs to be done to ascertain who needs booster doses.
19th Jan 2022 - Reuters

Mild COVID cases still lead to attention and memory issues - study

People with mild COVID-19 who do not suffer any other traditional "long COVID" symptoms can still exhibit deteriorated attention and memory six to nine months after infection, a study by Britain's Oxford University has found. Cognitive issues impacting concentration levels, along with forgetfulness and fatigue, are features of long COVID - a condition that afflicts some after an initial bout of infection - but it has not been established how widespread issues with attention span might be following COVID-19 infection.
19th Jan 2022 - Reuters

Fuzzy Hamsters Are Hong Kong’s Newest Enemy in Its Covid-Zero Campaign

Authorities ordered some 2,000 hamsters in Hong Kong to be killed over concerns that the animals may have transmitted Covid-19 to humans, one of the city’s latest measures to try to stamp out a fresh outbreak. Under the latest order, authorities will cull the animals at almost three dozen pet shops across the city, including a store selling small animals linked to two recent Covid-19 infections in the city. One of the two infections was an employee at the pet store, while another was a recent visitor to the store, authorities said. Health chiefs said the order was being made out of prudence as there was no international evidence that pets can transmit the Covid-19 to humans.
19th Jan 2022 - The Wall Street Journal

To Help Battle Covid-19, a Hospital Borrows Tactics From Combat Veterans

At Rush University Medical Center, nurses still talk about their feelings of guilt from the early months of treating Covid-19 patients. How they hadn’t known how to best treat desperate patients. How worried they were about bringing Covid-19 home to their families. Except now they report having more mental and emotional tools at their disposal than they did at the beginning of the pandemic, thanks in large part to the work of Mark Schimmelpfennig, a hospital chaplain who is also an Army veteran. Mr. Schimmelpfennig months ago noticed that phrases nurses were using in conversation sounded like what he had heard from troops who had served in combat zones. The same techniques veterans use to wrestle with combat trauma also could be used by the healthcare profession, he said.
19th Jan 2022 - Wall Street Journal

Are hospital admissions still the best way to gauge the COVID crisis?

More people in hospital with COVID are there for other reasons. Italian regions want to overhaul way admissions counted. ICU occupancy may better reflect severity, scientist says. Omicron still putting hospitals under pressure, doctors warn
19th Jan 2022 - Reuters

Report outlines 8 steps for current, future pandemics

A new report from the Center for Strategic and International Studies (CSIS) comments on the "ineffectual and fragmented" US COVID-19 pandemic responses thus far and recommends eight steps to manage the ongoing crisis amid variant fatigue, inflation, and supply chain disruptions. CSIS, a bipartisan, nonprofit policy research organization based in Washington, DC, said it issued the recommendations to secure US global leadership in the next phase of the pandemic response. Among the steps recommended in the "2022 is the year of decision" report are to launch a US international pandemic readiness project and to appoint a presidential global health security envoy.
19th Jan 2022 - CIDRAP

Why big data didn’t deliver on its big promises to combat Covid-19

When the pandemic hit, technology companies pledged to do their part by cracking open their secretive datasets and letting public health researchers mine it for clues about how to bring Covid-19 under control. Two years in, it’s clear that big data isn’t the panacea they’d hoped for. In part, that’s because the pandemic has stretched far longer than most anticipated. But as Andrew Schroeder, a co-leader of the Covid-19 Mobility Data Network, lay out in an opinion published in PLOS Digital Health, it’s also because public health goals ran headlong into the business interests of the companies that provided their data for analysis, including Facebook and a cluster of ad-tech firms that tie clicks to location data.
18th Jan 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Jan 2022

View this newsletter in full

Pfizer’s New Covid-19 Pill Works Against Omicron in Lab

Pfizer Inc.’s new Covid-19 pill, Paxlovid, was effective against the Omicron variant in laboratory tests, an encouraging early sign the drug will be an important tool while the strain spreads. Pfizer said Tuesday the drug’s main component, nirmatrelvir, worked in three separate laboratory studies. Patients take two tablets of nirmatrelvir with one tablet of another antiviral called ritonavir twice a day for five days. The company issued the results by news release. The research hasn’t been published in a peer-reviewed medical journal.
19th Jan 2022 - The Wall Street Journal

Placebo effect accounts for more than two-thirds of COVID-19 vaccine adverse events, researchers find

The placebo effect is the well-known phenomenon of a person's physical or mental health improving after taking a treatment with no pharmacological therapeutic benefit—a sugar pill, or a syringe full of saline, for example. While the exact biological, psychological and genetic underpinnings of the placebo effect are not well understood, some theories point to expectations as the primary cause and others argue that non-conscious factors embedded in the patient-physician relationship automatically turn down the volume of symptoms
18th Jan 2022 - Medical Xpress

Merck signs supply deal with UNICEF for 3 mln courses of COVID-19 pill

Merck & Co Inc and partner Ridgeback Biotherapeutics said on Tuesday they had signed an agreement with the United Nations Children's Fund (UNICEF) to supply up to 3 million courses of their COVID-19 antiviral pill. Merck would supply the pill, molnupiravir, to UNICEF through the first half of 2022 for distribution in more than 100 low- and middle-income countries upon regulatory authorizations, the companies said. The pill received authorization from the U.S. Food and Drug Administration in December and has also been authorized in several other countries including India, Mexico and the UK. Many countries have signed supply deals with Merck for the drug.
18th Jan 2022 - Reuters

EU regulator finds mRNA COVID-19 shots safe during pregnancy

COVID-19 vaccines made using mRNA technology do not cause pregnancy complications for expectant mothers and their babies, the European Union's drug regulator said on Tuesday, following a detailed review of several studies. The review based on studies involving around 65,000 pregnancies at different stages did not find any sign of higher risk of complications, miscarriages, preterm births or severe side-effects on the unborn babies from mRNA shots, the European Medicines Agency said.
18th Jan 2022 - Reuters

Hong Kong to cull 2000 hamsters after COVID-19 outbreak

Hong Kong warned people not to kiss pets and ordered a mass cull of hamsters on Tuesday, to the outrage of animal-lovers, after 11 of the rodents tested positive for COVID-19. A recent coronavirus cluster in humans traced to a pet shop worker prompted checks on hundreds of animals in the Chinese-ruled territory, with 11 hamsters found infected, officials said. Echoing the mainland's zero-tolerance policy even as much of the world shifts to living with COVID, Hong Kong ordered 2,000 hamsters "humanely" put down, and imports and sales stopped.
18th Jan 2022 - Reuters

WHO urges manufacturers to provide COVID-19 vaccine data

A World Health Organization committee urged COVID-19 vaccine manufacturers on Tuesday to provide it with the data it requires in order to list their shots for emergency use, saying the delays were affecting equitable vaccine access. An emergency use listing with the U.N. agency means shots can be shipped to multiple developing nations that rely on WHO guidance for their regulatory decisions. It also allows them to be used by the COVAX vaccine-sharing programme that aims to ramp up vaccinations in poorer countries.
18th Jan 2022 - Reuters

Covid-19 Infected Lions Prompt Variant Warning in South Africa

Lions and pumas at a zoo in the South African capital of Pretoria got severe Covid-19 from asymptomatic zoo handlers, raising concerns that new variants could emerge from animal reservoirs of the disease,
18th Jan 2022 - Bloomberg

‘Deltacron’: Should we worry about new COVID-19 variants merging?

During the past week, my inbox has been flooded with messages telling me a new COVID-19 variant had been discovered in Cyprus. Dubbed “Deltacron”, it was said to be responsible for a series of hospitalisations in the country. I groaned at the thought of a new variant and one that was said to be a combination of the Delta and Omicron variants sounded ominous. So, I decided to do some digging.
18th Jan 2022 - Al Jazeera English

2,000 hamsters to be culled in Hong Kong over fears of animal-to-human Covid-19 link

Hong Kong authorities have asked pet shops and owners to hand over about 2,000 hamsters for a mass cull and temporarily suspended imports of small animals after finding evidence of the first possible animal-to-human transmission of Covid-19 in the city. Officials on Tuesday also ordered all 34 licensed pet stores that sell hamsters to suspend operations and about 150 customers who had visited the Little Boss shop in Causeway Bay since January 7 to enter quarantine. Pet owners whose hamsters test positive must also be isolated as well. While animal welfare groups expressed shock at the “drastic action”, authorities and health experts stressed the risks to public health made the cull necessary. Two people tied to the Little Boss shop have been confirmed as infected and another is listed as a suspected case, while 11 hamsters from the store were categorised as preliminary-positive.
18th Jan 2022 - South China Morning Post

'The next variant is just around the corner': Experts warn the world's at risk until all are vaccinated

New Covid-19 variants are likely to keep on emerging until the globe has been vaccinated against the virus, experts warn, saying that the sharing of vaccines is not just an altruistic act but a pragmatic one. “Until the whole world is vaccinated, not just rich Western countries, I think we are going to remain in danger of new variants coming along and some of those could be more virulent than omicron,” Dr. Andrew Freedman, an academic in infectious diseases at Cardiff University Medical School, told CNBC on Thursday. Viruses “tend to become milder” as they evolve, Freedman noted, but he cautioned that this “isn’t always the case.”
18th Jan 2022 - CNBC

Your Child's Fussy Eating May Stem From Covid-19

Covid infection could be turning more and more children into fussy eaters, experts have suggested. This may be because they are suffering from parosmia - a disorder where people experience strange and often unpleasant smell distortions. For example, chocolate may smell like petrol, or someone may smell rotting cabbage instead of lemon. Smell experts at the University of East Anglia and Fifth Sense, the charity for people affected by smell and taste disorders, say children in particular may be finding it hard to eat foods they once loved. Fifth Sense and Carl Philpott, from UEA's Norwich Medical School, are launching guidance to help parents and healthcare professionals better recognise the disorder.
18th Jan 2022 - Bloomberg

China cites coronavirus on packaging, despite doubts abroad

Chinese state media say parcels mailed from overseas may have spread the omicron variant of the coronavirus in Beijing and elsewhere, despite doubts among overseas health experts that the virus can be transmitted via packaging. The State Post Bureau said it has ordered stronger measures to ventilate and disinfect sites where items mailed from overseas are handled. Postal workers must wear protective equipment, receive booster shots and undergo regular testing, it said on its website. International packages must be isolated, cleaned and held for a waiting period to ensure they are free from the virus, it said. Global health experts say the virus mainly spreads through respiratory droplets when infected people breathe, speak, cough and sneeze.
18th Jan 2022 - The Associated Press

Uncorking today’s Covid-19 supply chain to meet the challenges of future pandemics

At what point do the benefits of local production of medical supplies outweigh the potentially higher cost? The sudden and near-overwhelming demand for Covid-19 testing during the Omicron phase of the pandemic means that the U.S. is now at a critical point where we need better — and quicker — access to testing supplies via a domestic supply chain. Over the last three decades, the world’s economy has become increasingly globalized, resulting in lower inflation-adjusted prices for goods and products and improved standards of living around the world. The Covid-19 pandemic has provided an opportunity to once again debate the United States’ reliance on inexpensive overseas manufacturing, and reconsider the value of high-quality domestic production.
18th Jan 2022 - STAT News

U.S. would seek global approach to updating Covid-19 vaccines, official says

If the Food and Drug Administration decides to update Covid-19 vaccines to take better aim at Omicron or other variants, it is unlikely to go it alone. Instead, a senior FDA official told STAT, the agency expects to take part in an internationally coordinated program aimed at deciding if, when, and how to update Covid-19 vaccines. The approach would ensure decisions are not left solely to individual vaccine manufacturers. “We can’t have our manufacturers going willy-nilly [saying], ‘Oh well, the EMA decided they wanted this composition, but FDA wanted that composition,’” the official said, referring to the European Medicines Agency. “So we are very much of the mind that we would like to be part of a more global process in helping to come to what vaccine composition there should be now.”
18th Jan 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Jan 2022

View this newsletter in full

India's Gennova developing Omicron-specific COVID-19 vaccine

India's Gennova Biopharmaceuticals is working on an Omicron-specific mRNA COVID-19 vaccine candidate, it told Reuters on Monday, after a person with direct knowledge of the matter said the product could be ready in a month or two. "The Omicron-specific variant of the vaccine is under development and will be ready for human clinical trials, subject to regulatory approvals," a company spokesperson said in a text message. "We will keep you posted."
17th Jan 2022 - Reuters

Study evaluates acute and long-term adverse events following immunization with COVID-19 Moderna vaccine

In a recent study posted to the medRxiv* pre-print server, a team of researchers conducted a case-control study at a mass vaccination center in Japan to evaluate acute and long-term adverse events following immunization (AEFI) with coronavirus disease 2019 (COVID-19) Moderna vaccine. There were 3,014 incidences of AEFI in 2,913 Moderna vaccine recipients, of which 101 recipients showed AEFI twice, first at the time of receiving the first dose and next on receiving the second vaccine dose. Except for anaphylaxis, the incidence rate of AEFI at the first dose was significantly higher than at the time of the second dose. Among the 1,201,688 vaccine recipients, the incidence rate of IHSR was 266, ISRR was 2129, anaphylaxis was two, and vasovagal syncope was 72. Among the 611,238 vaccine recipients without AEFI, 1,208 recipients were selected as matched controls 1 for Cases 1 and 9,940 recipients as control 2 for Cases 2.
17th Jan 2022 - News Medical

A Thai start-up is working on a Covid vaccine — using tobacco leaves

Thailand’s Baiya Phytopharm wants to develop the the country’s first plant-based Covid vaccine. The start-up completed phase one human trials of the shot in December. Baiya says it’s still too early to ascertain its efficacy, but the goal is to use available vaccines as a benchmark.
17th Jan 2022 - CNBC

Covid-19: Severe complications during pregnancy are more common in unvaccinated women, study finds

Unvaccinated women accounted for 77% of SARS-CoV-2 infections that have occurred during pregnancy in Scotland and 98% of infections that led to a critical care admission, a study has found. Researchers looked at 4950 confirmed infections in pregnant women from 1 December 2020—when routine SARS-CoV-2 testing of maternity admissions began—which were spread relatively evenly throughout pregnancy (1543 in the first trimester, 1850 in the second, and 1557 in the third). They found that “severe complications,” such as critical care admission, stillbirths, and early neonatal deaths, were more common in those who were unvaccinated compared with those who were vaccinated. Commenting on the study, Asma Khalil, professor of obstetrics and maternal fetal medicine at St George’s University of London, said, “The study shows that the overwhelming majority of pregnant women and babies becoming unwell or dying as a result of covid-19 were unvaccinated. The pandemic is far from over and with tens of thousands of covid-19 cases still being reported in the UK every day, it is paramount that pregnant women continue to take up the offer of a vaccine.”
17th Jan 2022 - The BMJ

Covid-19: Focus should be on new vaccines rather than boosters, says WHO

Giving repeated booster doses of existing covid-19 vaccines in developed countries is not a sustainable global strategy for tackling the pandemic, the World Health Organization has said. Instead, WHO argues that the focus should shift towards producing new vaccines that work better against transmission of emerging variants. In a statement1 published on 11 January, the WHO Technical Advisory Group on Covid-19 Vaccine Composition said, “A vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.” The expert group, which is assessing the performance of covid-19 vaccines, said that to deal with emerging variants such as omicron, new vaccines needed to be developed that not only protect people against serious illness but against infection. “Covid-19 vaccines that have high impact on prevention of infection and transmission, in addition to the prevention of severe disease and death, are needed and should be developed,” the group said.
17th Jan 2022 - The BMJ

Pfizer to boost COVID-19 pill production with French deal

Pfizer will add a production facility for its antiviral COVID-19 pill in France as part of a plan to invest 520 million euros ($594 million) in the country over the next five years, the U.S. drugmaker said on Monday. The decision is part of Pfizer's strategy to boost global production of the pill, paxlovid, which was found to be nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to clinical trial data. The investment will initially involve the production of active pharmaceutical ingredient (API) for paxlovid at a plant run by French pharmaceutical group Novasep, Pfizer said, noting that additional Novasep facilities will be added next year.
17th Jan 2022 - Reuters

Pakistan says trial of Chinese traditional medicine for COVID-19 successful

Pakistani health authorities on Monday announced the completion of a successful clinical trial of Chinese traditional herbal medicine for treating COVID-19, as the South Asian nation enters a fifth wave of the pandemic driven by the Omicron variant. The Chinese medicine, Jinhua Qinggan Granules (JHQG) manufactured by Juxiechang (Beijing) pharmaceutical Co Ltd, is already being used in treatment of COVID-19 patients in China. "Since it was tried on patients with different variants of COVID-19, we expect it to be effective on Omicron as on other variants," Professor Iqbal Chaudhry, director of the International Center for Chemical and Biological Science (ICCBS) where trials were conducted, told reporters.
17th Jan 2022 - Reuters

Which Mask Is Best for Covid N95, KN95 or Cloth? Understanding 2022 Guidance

Advice from U.S. authorities on the need for face masks has flipped back and forth since Covid-19 took hold in 2020. In May, the Centers for Disease Control and Prevention said immunized Americans could ditch their masks in most settings. It reversed course in July amid a rise in cases caused by the more transmissible delta variant. Now, with the quickly spreading omicron variant causing a surge in infections, the agency is urging wider use of medical-grade masks in the general public. It revised earlier guidelines that had discouraged the use of gold-standard N95 masks in order to reserve them for medical workers.
17th Jan 2022 - Bloomberg

What do we know about the 175,000 people who died of Covid in the UK?

Two startlingly different figures for what is ostensibly the same count have been released within days of each other: the government reported 150,000 Covid-19 deaths days before the UK’s lead statistical agency reported a death toll of more than 175,000. The difference between the two figures is stark but easily explained: the government’s figures count only those deaths that are known to have occurred within 28 days of a positive coronavirus test. The Office for National Statistics, on the other hand, counts all deaths where the virus was mentioned on the death certificate. But regardless of the counting method, the numbers represent individual human tragedies. So, what do we know about the 175,000 people whose deaths have been recorded to date?
17th Jan 2022 - The Guardian

Australia regulator flags 'significant concerns' of price hike in COVID-19 antigen tests

Australia's competition regulator on Monday said it had "significant concerns" about reports of price gouging of COVID-19 rapid antigen tests and sought information from suppliers, retailers and pharmacy chains about rising costs. Australia is facing a shortage of at-home rapid antigen test kits after authorities urged asymptomatic close contacts to bypass government-funded testing hubs, where high volumes delayed results, and take their own tests. "In the middle of a significant outbreak of COVID-19 in a pandemic, the excessive pricing of rapid antigen tests required to diagnose the illness and protect other members of the public, is of significant concern," the Australian Competition and Consumer Commission (ACCC) Chair Rod Sims said.
17th Jan 2022 - Reuters

At Davos, a ‘good news, bad news’ message emerges about Covid-19

As the coronavirus continues to wreak havoc, an expert panel at the World Economic Forum delivered a mix of good news and bad news on Monday: More variants will emerge, but vaccine production is accelerating and research is progressing toward a combined shot that may be able to attack these different variants. On one hand, the world needs to prepare for newer strains that could be more vexing, or the “worst case scenario,” said Annelies Wilder-Smith, a professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine. “Omicron will not be the last variant. There’s a high probability we will have another variant coming up. The question is when and will it be less dangerous?”
17th Jan 2022 - STAT News

Covid-19: Pregnant women urged to get vaccine after new study

Pregnant women have been urged to get vaccinated after a new study found an increased risk of birth-related complications after getting Covid-19. Northern Ireland's chief medical officer said Covid in the later stages "can have serious consequences for both mother and baby". Sir Michael McBride said having Covid-19 during pregnancy "carries a far higher risk than having the vaccine". It comes as the Omicron variant continues to spread in communities. A University of Edinburgh study found that pre-term births, stillbirths and new-born deaths are more common among women who have Covid-19 28 days, or less, before their delivery date. The study's authors said that "addressing low vaccine uptake in pregnant women is imperative to protect the health of women and babies"
17th Jan 2022 - BBC News

WHO recommends two new drugs to treat COVID-19

WHO has recommended two new drugs for COVID-19, providing yet more options for treating the disease. The extent to which these medicines will save lives depends on how widely available and affordable they will be. The first drug, baricitinib, is strongly recommended for patients with severe or critical COVID-19. It is part of a class of drugs called Janus kinase (JAK) inhibitors that suppress the overstimulation of the immune system. WHO recommends that it is given with corticosteroids. Baricitinib is an oral drug, used in the treatment of rheumatoid arthritis. It provides an alternative to other arthritis drugs called Interleukin-6 receptor blockers, recommended by WHO in July 2021.
16th Jan 2022 - World Health Organization

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Jan 2022

View this newsletter in full

Thailand and Indonesia unveil plans to develop molnupiravir COVID-19 pill

Thailand's health minister said on Friday the country planned to develop the anti-viral pill molnupiravir to combat COVID-19 infections amid rising infections driven by the Omicron variant. The molnupiravir COVID-19 treatment pill for adult patients at risk of developing severe illness was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics. The Southeast Asian nation intends to join other countries in the region also planning to make versions of the drug including Bangladesh and India.
15th Jan 2022 - Reuters

South African study suggests Omicron less severe even for unvaccinated

Unvaccinated people infected with the Omicron variant of coronavirus may be less prone to severe illness and requiring hospital care or dying than was the case with previous variants, a South African study showed on Friday. The study, by the National Institute of Communicable Diseases (NICD) in the Western Cape region, which has not yet been peer-reviewed, concluded.compared about 11,600 patients from the first three COVID-19 waves with about 5,100 from the Omicron-driven wave that began in November. Omicron globally has tended to cause less severe disease, and proportionally fewer hospital admissions and deaths, than previous variants.
15th Jan 2022 - Reuters

Italy's sewers will give early alert for future COVID spikes

Italy will use the nation's sewage to predict future coronavirus spreads and to alert authorities to rising cases and new variants before they appear in testing and hospitals, a senior official said, announcing a project to be launched in coming months. The new tool will be rolled out as governments look for new ways to track the virus to inform public health policy and to decide whether they have to take unpopular measures like restrictions that disrupt people's lives and economies. It could also be useful amid concerns about shortages of testing kits and labs being overwhelmed as the more infectious Omicron variant sweeps the world. Like many other countries, Italy is seeing surging cases.
15th Jan 2022 - Reuters

EMA lists rare spinal condition as side effect of AstraZeneca's COVID-19 shot

A safety panel of the European drug regulator on Friday recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca's COVID-19 vaccine. The European Medicines Agency's (EMA) safety committee also recommended a similar warning be included for Johnson & Johnson's (JNJ.N) one-shot vaccine in October, and reiterated the decision on Friday. Transverse myelitis is an inflammation of one or both sides of the spinal cord and can cause weakness in the arms or legs, sensory symptoms or problems with bladder or bowel function.
15th Jan 2022 - Reuters

UK study finds more Omicron hospitalisations in youngest children, but cases mild

Young children and babies are proportionally more likely to be hospitalised with Omicron compared to older children than with previous variants but the cases are still mild, British researchers said, adding the overall picture was reassuring. Omicron has spread rapidly in Britain and fuelled a spike in cases to record highs, though the variant is less severe than previous ones, and high vaccination levels among adults have also helped to limit the rise in hospitalisations. Children are less vulnerable than older adults to COVID-19.
15th Jan 2022 - Reuters

Study finds COVID-19 may increase risk of diabetes in kids: What parents should know

Kids who have recovered from COVID-19 may have an increased risk of developing diabetes, according to a new study from the Centers for Disease Control and Prevention. The study, which looked at databases with information for over 2.5 million patients under 18, found that children diagnosed with COVID-19 were about 2.5 times more likely to receive a new diabetes diagnosis a month or more after infection.
14th Jan 2022 - ABC News

New study says air knocks down COVID-19 infection rate by 90 percent

New research found that after COVID-19 becomes airborne, the virus loses infectivity by 50 to 60 percent within seconds. By the first two minutes, the infectivity rate of COVID-19 dropped further by 90 percent. The new research was published out of the U.K. and has yet to be peer-reviewed.
14th Jan 2022 - The Hill

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Jan 2022

View this newsletter in full

Covid in Pregnancy Linked to Stillbirths and Newborn Deaths, Study Suggests

Women who have Covid-19 towards the end of their pregnancy are more vulnerable to stillbirths, newborn deaths and birth related complications, a new study suggests. The research also found that most complications occurred in women who were not vaccinated, with the majority (98%) of pregnant women with Covid-19 who were admitted to critical care being unvaccinated. The study, which included more than 87,000 women in Scotland, found that preterm births, stillbirths and newborn deaths were more common among women who had the virus 28 days or less before their delivery date, compared to background rates. All the women whose babies died had not been vaccinated against Covid-19 at the time of infection, though experts stressed that it is not possible to say if Covid-19 contributed directly to the deaths or preterm births as they did not have access to detailed clinical records for individual women.
13th Jan 2022 - Bloomberg

How Does Covid Spread? Virus' Infection Capacity Weakens After 20 Minutes in Air

Coronavirus loses most of its ability to infect shortly after being exhaled and is less likely to be contagious at longer distances, a study from the University of Bristol’s Aerosol Research Centre showed. Researchers found that the virus loses 90% of its contagion capacity 20 minutes after becoming airborne and that most of that loss happens in the first five minutes of it reaching the air, according to the study, that simulates how the virus behaves after exhaling. With some countries opening the debate in Europe about an endemic phase to the virus, insights into the way the virus travels across the air will help guide containment measures.
13th Jan 2022 - Bloomberg

New data finds AstraZeneca booster generates higher antibodies against Omicron

AstraZeneca said on Thursday preliminary data from a trial it conducted on its COVID-19 shot, Vaxzevria, showed it generated a higher antibody response against the Omicron variant and others, including Beta, Delta, Alpha and Gamma, when given as a third booster dose. The increased response was seen in people who were previously vaccinated with either Vaxzevria or an mRNA vaccine, the drugmaker said, adding that it would submit this data to regulators worldwide given the urgent need for boosters. AstraZeneca has developed the vaccine with researchers from the University of Oxford, and lab studies last month found a three-dose course of Vaxzevria was effective against the rapidly spreading new variant.
13th Jan 2022 - Yahoo Finance

AstraZeneca says early trial data indicates third dose helps against Omicron

AstraZeneca said that preliminary data from a trial showed that its COVID-19 shot, Vaxzevria, generated an increase in antibodies against the Omicron and other variants when given as a third booster dose. The increased response, also against the Delta variant, was seen in a blood analysis of people who were previously vaccinated with either Vaxzevria or an mRNA vaccine, the drugmaker said, adding that it would submit this data to regulators worldwide given the urgent need for boosters. read more
13th Jan 2022 - Reuters

Swissmedic temporarily approves Regkirona COVID-19 treatment

Swiss drugs regulator Swissmedic said on Thursday it had granted temporary approval to Regkirona, antibody medicine that can be used for the treatment of COVID-19 in adults. Swissmedic said the applicant did not submit any information on its efficacy against the highly contagious Omicron variant of the coronavirus. Regkirona, which contains the active substance regdanvimab, can be used to treat adult COVID patients if oxygen therapy or hospitalisation is not required, and there is a high risk of developing a severe form of COVID-19.
13th Jan 2022 - Reuters

Moderna expects COVID-19 vaccine trial data for children aged 2-5 in March

Moderna Inc said on Wednesday it expects to report data from its COVID-19 vaccine trial in children aged between 2 to 5 years in March. "If the data is supportive and subject to regulatory consultation, Moderna may proceed with regulatory filings for children 2-5 years of age thereafter," the company said. Moderna's vaccine, based on the messenger RNA platform, already has authorizations in Europe, UK, Australia, and Canada for adolescents aged 12-17 years, and has submitted applications for children in 6 to 11 years.
13th Jan 2022 - Reuters

Long COVID brain fog found similar to 'chemo brain'; clip-on device shows promise in virus detection

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Long COVID "brain fog" shares features with "chemo brain" The "brain fog" reported by some people after COVID-19 shows striking similarities to the condition known as "chemo brain" - the mental cloudiness some people experience during and after cancer treatment, according to new research.
13th Jan 2022 - Reuters

COVID-19 pill rollout stymied by shortages as omicron rages

Two brand-new COVID-19 pills that were supposed to be an important weapon against the pandemic in the U.S. are in short supply and have played little role in the fight against the omicron wave of infections. The problem, in part, is that production is still being ramped up and the medicines can take anywhere from five to eight months to manufacture. While the supply is expected to improve dramatically in the coming months, doctors are clamoring for the pills now, not just because omicron is causing an explosion of cases but because two antibody drugs that were once the go-to treatments don’t work as well against the variant.
13th Jan 2022 - Scientific Viewpoint

UK virus hunting labs seek to bolster global variant network

The air conditioners hum constantly in the lab at the Wellcome Sanger Institute, countering the heat thrown off by rows of high-tech sequencing machines that work seven days a week analyzing the genetic material of COVID-19 cases from throughout the U.K. The laboratory is one example of how British scientists have industrialized the process of genomic sequencing during the pandemic, cutting the time and cost needed to generate a unique genetic fingerprint for each coronavirus case analyzed. That made the U.K. a world leader in COVID-19 sequencing, helping public health authorities track the spread of new variants, develop vaccines and decide when to impose lockdowns. But now researchers at the Sanger Institute in Cambridge and labs around the U.K. have a new mission: sharing what they’ve learned with other scientists because COVID-19 has no regard for national borders.
13th Jan 2022 - The Associated Press

Unvaccinated pregnant people are at higher risk for Covid complications and newborn deaths

Unvaccinated pregnant people who get Covid-19 are at much higher risk for complications from the disease and death of their babies than their vaccinated counterparts, according to a new study from Scotland. Authors of the population-level study, published Thursday in Nature Medicine, examined data from all pregnant people across Scotland between December 2020 and October 2021 that included information on Covid-19 vaccination status and infection. Almost all of the pregnant people who needed critical care for Covid-19 — 102 out of 104 overall — were unvaccinated. There were over 450 total fetal and newborn deaths that coincided with Covid-19 — all among unvaccinated mothers. “Vaccination in pregnancy is the safest and most effective way for pregnant women to protect themselves and their babies,” said Sarah Stock, an author of the study who is an obstetrician and maternal and fetal medicine specialist at the University of Edinburgh. “This advice needs to go out to partners and parents and grandparents and friends.”
13th Jan 2022 - STAT News

Polish scientists find gene that doubles risk of serious COVID

Polish scientists have found a gene that they say more than doubles the risk of becoming severely ill with COVID-19, a discovery they hope could help doctors identify people who are most at risk from the disease. With vaccine hesitancy a major factor behind high coronavirus death rates in central and eastern Europe, researchers hope that identifying those at greatest risk will encourage them to get a shot and give them access to more intensive treatment options in case of an infection. "After more than a year and a half of work it was possible to identify a gene responsible for a predisposition to becoming seriously ill (with coronavirus)," said Health Minister Adam Niedzielski.
13th Jan 2022 - Reuters

Pfizer's Covid-19 antiviral pill was hailed as a game-changer, but supplies are scarce

The Omicron variant of the coronavirus is causing Covid-19 cases to spike, with an average of more than 747,000 new cases a day, according to the latest numbers from Johns Hopkins University. That's almost three times the average daily cases from a year ago, when the country was going through its previous peak, and it's putting an incredible strain on hospitals and emergency rooms. The good news since the last peak is that the US Food and Drug Administration authorized new antiviral pills. Both Paxlovid and molnupiravir were given emergency use authorization in late December to treat mild to moderate Covid-19. They interfere (through different pathways) with the virus' ability to replicate -- and they can be taken at home, before someone becomes seriously ill.
13th Jan 2022 - CNN

Global study notes risk factors for uncommon severe COVID-19 in kids

A 10-country study of more than 3,000 children who tested positive for COVID-19 in emergency departments (EDs) finds that 3% went on to develop severe disease within 2 weeks, with risk factors being older age, having chronic conditions, and experiencing symptoms longer. The study was published yesterday in JAMA Network Open. An international group of scientists report that, among 3,221 children 17 years and younger studied in Argentina, Australia, Canada, Costa Rica, Italy, New Zealand, Paraguay, Singapore, Spain, and the United States, 107 (3.3%) experienced severe outcomes within 2 weeks, and 4 (0.12%) died. Among children discharged home from the ED, the risk was much lower.
12th Jan 2022 - CIDAP

AstraZeneca sells another half-million doses of its COVID-19 antibody combo to the US

Order up. Shortly after topping off supplies of COVID-19 drugs from Pfizer and GlaxoSmithKline, the U.S. has asked for a second helping of AstraZeneca’s antibody combo. The government has purchased an additional 500,000 doses of AZ’s long-acting antibody cocktail Evusheld, or tixagevimab plus cilgavimab. That comes on top of 700,000 doses the U.S. already ordered, for a total supply of 1.2 million, the British drugmaker said Wednesday. AstraZeneca plans to complete the entire delivery within the first quarter of 2022. Unlike the COVID-19 antibody drugs from Eli Lilly, Regeneron and GlaxoSmithKline-Vir Biotechnology, AstraZeneca’s therapeutic is authorized for prevention before exposure to the virus. Specifically, the FDA in December authorized Evusheld in people with moderately to severely compromised immune systems, either from a medical condition or the use of immunosuppressive medications. People with a history of severe reactions to COVID-19 vaccines are also eligible to receive the therapeutic.
12th Jan 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Jan 2022

View this newsletter in full

Cannabis Compounds Prevented Covid Infection in Laboratory Study

Cannabis compounds prevented the virus that causes Covid-19 from penetrating healthy human cells, according to a laboratory study published in the Journal of Nature Products. The two compounds commonly found in hemp -- called cannabigerolic acid, or CBGA, and cannabidiolic acid, or CBDA -- were identified during a chemical screening effort as having potential to combat coronavirus, researchers from Oregon State University said. In the study, they bound to spike proteins found on the virus and blocked a step the pathogen uses to infect people. The researchers tested the compounds’ effect against alpha and beta variants of the virus in a laboratory. The study didn’t involve giving the supplements to people or comparing infection rates in those who use the compounds to those who don’t.
12th Jan 2022 - Bloomberg

Third dose of mRNA COVID vaccine induces strong immunity in older adults

The study results showed that two doses of an mRNA vaccine in older adults produced significantly lower levels of humoral response in terms of both binding and neutralizing antibodies as compared to younger people throughout the period of assessment. After a two-dose mRNA vaccine regimen, the predictors of weak binding antibody response included having more concomitant illnesses. Conversely, having a longer gap between the first and second doses was linked to a superior binding antibody response, confirming earlier reports. However, binding antibody levels fell faster in older adults, which is likely due to the more significant number of health conditions in this group.
12th Jan 2022 - News-Medical.Net

Fauci warns of ‘urgent need’ for super vaccine as other variants emerge

Dr Anthony Fauci warned at a Senate committee hearing that the US faced an “urgent need” for a so-called super vaccine that would be more effective at preventing new variants of Covid-19 and other coronaviruses. “Looking ahead in the context of the inevitable continual emergence of new variants, the importance of developing a pan-coronavirus vaccine, namely one that would be effective against all SARS-COVID-2 variants, and ultimately against all coronaviruses, becomes even more apparent,” he told the senators on Tuesday. He added that there was an “urgent need for such an effort”, and added that NIAID was making significant progress on the issue.
12th Jan 2022 - The Independent

Novavax coronavirus vaccine authorized in South Korea

South Korea’s drug regulator on Wednesday granted final authorization to Novavax’s coronavirus vaccine for use in adults, health officials said in a news release, making it the fifth coronavirus vaccine available in the country. Although the authorization is conditioned on the Maryland-based company’s submission of the final results of clinical studies regarding its vaccine, the Ministry of Food and Drug Safety said Novavax’s coronavirus vaccine has received “final” approval in South Korea. The vaccine, which will be produced locally, is effective and safe, the regulator said.
12th Jan 2022 - The Washington Post

Pfizer study shows COVID-19 booster can be given along with pneumonia shot

Pfizer Inc said on Wednesday booster doses of its COVID-19 vaccine can be administered along with its pneumonia vaccine and produced strong safety and immune responses in people aged 65 and above in a late-stage study. The study, initiated in May, tested the company's next-generation pneumococcal conjugate vaccine, PREVNAR 20, with a third dose of the Pfizer-BioNTech COVID-19 shot in 570 participants. The aim of the study was to test the safety of the combination and the immune response after adding the pneumonia vaccine to the existing COVID-19 vaccine.
12th Jan 2022 - Reuters

S.Korea authorises Novavax COVID-19 vaccine, imports Pfizer pills

South Korea is turning to additional pharmaceutical tools as it looks to pre-empt a surge of COVID-19 omicron infections, authorising the use of Novavax Inc's vaccine on Wednesdayand preparing to distribute the first of Pfizer's antiviral pills. At least 21,000 of Pfizer's antiviral pills, called Paxlovid, will arrive in South Korea on Thursday, with another 10,000 more expected to arrive by the end of the month, the health ministry said. The pills, which were authorised for emergency use in December, will begin being used in treatments for more than 1,000 people per day starting on Friday, the ministry added
12th Jan 2022 - Reuters

A Deceptive Covid Study, Unmasked

An honest summary of the study might have said: “There is a low transmission rate of the virus among students, even when unmasked at lunch or during sports.” But a summary like that wouldn’t have reinforced the politically acceptable message of public-health authorities today, and so unfounded points had to be fashioned to fit the narrative. This isn’t a first for the ABC collaborative and the Duke press office. In July they made a series of bold claims about the efficacy of masking children in schools based on a study that didn’t include an unmasked control group. Scientific communication should limit itself to the communication of science, rather than to the manipulation of human behavior.
12th Jan 2022 - The Wall Street Journal

Omicron Causes Fewer and Shorter Hospitalizations, Study Shows

A new study of nearly 70,000 Covid patients in California demonstrates that Omicron causes less severe disease than other coronavirus variants, results that align with similar findings from South Africa, Britain and Denmark, as well as a host of experiments on animals. Compared with Delta, Omicron infections were half as likely to send people to the hospital. Out of more than 52,000 Omicron patients identified from electronic medical records of Kaiser Permanente of Southern California, a large health system, the researchers found that not a single patient went on a ventilator during that time.
12th Jan 2022 - The New York Times

Repeat Booster Shots Spur European Warning on Immune-System Risks

European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune response and may not be feasible. Repeat booster doses every four months could eventually weaken the immune response and tire out people, according to the European Medicines Agency. Instead, countries should leave more time between booster programs and tie them to the onset of the cold season in each hemisphere, following the blueprint set out by influenza vaccination strategies, the agency said. The advice comes as some countries consider the possibility of offering people second booster shots in a bid to provide further protection against surging omicron infections. Earlier this month Israel became the first nation to start administering a second booster, or fourth shot, to those over 60.
12th Jan 2022 - Bloomberg

Covid Study to Assess Pfizer, J&J Suitability for HIV Infected

A South African Covid-19 vaccine trial will assess the safety and impact of varying doses of Johnson & Johnson and Pfizer Inc. shots as boosters for those infected with HIV as well as the wider population. The study being carried out by the Johannesburg-based Wits Reproductive Health and HIV Institute will recruit about 300 health workers, of which about a third will be HIV positive, said Lee Fairlie, head of child and maternal health at the institute. With about 8.2 million people in South Africa, or 13% of the population, infected with HIV, the effectiveness, or immunogenicity, of Covid-19 vaccines in generating an immune system response in immuno-compromised individuals has been a key concern. HIV causes AIDS, which weakens the immune system.
12th Jan 2022 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Jan 2022

View this newsletter in full

5 reasons you should not deliberately catch Omicron to 'get it over with'

The idea of intentionally trying to catch Omicron is "all the rage," said Dr. Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia, with an exasperated sigh. "It's caught on like wildfire," agreed Dr. Robert Murphy, executive director of the Havey Institute for Global Health at Northwestern University Feinberg School of Medicine. "And it's widespread, coming from all types of people, the vaccinated and boosted and the anti-vaxxers," he added, with a warning. "You'd be crazy to try to get infected with this. It's like playing with dynamite." In case the thought had crossed your mind, here are five reasons why you should not purposely try to catch Omicron.
11th Jan 2022 - CNN

WHO says more research needed on vaccine efficacy against Omicron

A World Health Organization technical body said on Tuesday that current COVID-19 vaccines may need to be reworked to ensure they are effective against Omicron and future variants of the coronavirus. The technical group, made up of independent experts, said it would consider a change in vaccination composition and stressed that shots needed to be more effective in protecting against infection. "The composition of current COVID-19 vaccines may need to be updated to ensure that COVID-19 vaccines continue to provide WHO-recommended levels of protection against infection and disease by VOCs (variants of concern), including Omicron and future variants," the technical body, tasked with making recommendations to the WHO, said in a statement.
11th Jan 2022 - Reuters

Novavax CEO says its Covid vaccine could be cleared in multiple countries over next 90 days

The Novavax Covid-19 vaccine could be cleared by 10 regulators for use in multiple countries, including the U.S., in the coming months, the vaccine maker’s CEO said Monday. The company expects feedback from American regulators in February, Stanley Erck told CNBC’s “Squawk on the Street.” The vaccine is currently available for use in 170 countries.
11th Jan 2022 - CNBC

Moderna vaccines the best — and Sinovac least effective — at stopping covid deaths, Singapore data suggests

In a real-world indicator of how coronavirus vaccines are performing, Singapore has released new figures suggesting shots produced by Moderna and Pfizer-BioNTech are much more effective at preventing deaths than the Chinese-developed Sinopharm and Sinovac doses. Eight hundred and two people died of covid-19 in the city state in 2021, of which 555 were not fully vaccinated, while 247 received one of several locally available vaccines, Health Minister Ong Ye Kung told lawmakers on Monday. In terms of deaths per 100,000 people, there were 11 for those immunized with Sinovac and 7.8 for the Sinopharm vaccine, the state-affiliated Straits Times newspaper reported. The rate dropped for people who received messenger RNA — or mRNA — vaccines, with 6.2 deaths for Pfizer-BioNTech and one fatality for Moderna.
11th Jan 2022 - The Washington Post

Are Throat Swabs Better at Detecting Omicron in Covid-19 Rapid Tests?

A growing debate surrounds whether people testing for Omicron should swab their throats. Most people in the U.S. have been doing Covid-19 rapid tests with nasal swabs. That is what the Food and Drug Administration endorses and what rapid tests sold in the U.S. instruct. But some scientists say a throat swab may be more effective at detecting Omicron. Some are calling on the FDA and test manufacturers to better study throat swabs, saying that the reliance on nasal swabs may be one reason why rapid tests seem to be less sensitive in detecting Omicron than previous variants.
11th Jan 2022 - The Wall Street Journal

Wellcome Trust to spend £16bn on research with focus on Covid vaccines

The Wellcome Trust, Britain’s biggest charity, is ramping up spending on science research to £16bn over the next 10 years, with a focus on funding next-generation Covid vaccines, after it reaped the highest investment returns in a quarter of a century. Wellcome said it was making its biggest funding commitment to science and health in its 85-year history. It was created by the will of the pharmaceuticals entrepreneur Sir Henry Wellcome in 1936. The £16bn promise comes after it spent more than £9bn on research grants and other charitable activities over the past decade, including £1.2bn last year alone. The trust made a 34.5% return in the year to 30 September on its investment portfolio, which is now worth £38.2bn, about £10bn more than a year ago. This is its best performance since it was created in its present form as an independent charitable foundation in 1995, when Wellcome plc was sold off to the drugmaker Glaxo, which later became GlaxoSmithKline.
11th Jan 2022 - The Guardian

COVID-19 vaccine and periods: Study finds small, temporary change

Some may be hesitant to get vaccinated due to claims of a possible link between COVID-19 vaccines and abnormal menstrual cycles. So far, clinical trials of COVID-19 vaccines have not collected menstrual cycle data post-vaccine. By May 2021, however, a small number of people had reported menstrual-cycle-related issues. The authors of a new study write that “[t]he International Federation of Gynecology and Obstetrics classifies a variation in cycle length as normal if less than 8 days.” Also, stress can cause cycle lengths to varyTrusted Source or lead to a person skipping a cycle.
11th Jan 2022 - Medical News Today

Covid-19: We have good treatments for omicron, but questions remain, say doctors

Although the impact of omicron has largely been mitigated by vaccination, prior SARS-CoV-2 infection, and better treatments, general medical wards still face high numbers of patients, with many parts of the UK still bracing themselves for the peak, say clinicians. The most recent report from the Intensive Care National Audit and Research Centre (ICNARC),1 with data up to 7 January, showed that 629 had been patients admitted to critical care with covid-19 in the previous fortnight. As a proportion of overall hospital admissions, the figures for covid related critical care are at the lowest they have been since reporting began in April 2020. On 10 January 18 655 patients were in hospital with covid-19, with daily admissions reaching 2332.2 Simon Ashworth, a consultant in intensive care medicine at Imperial College Healthcare NHS Trust, told The BMJ, “Hospitals are very full, emergency departments are really busy, there are lots of admissions, difficulties in getting people into care homes, and we need to isolate covid patients from others.”
11th Jan 2022 - The BMJ

WHO warns against treating Covid-19 like flu

The World Health Organization (WHO) on Tuesday warned against treating COVID-19 as an endemic illness like flu, rather than as a pandemic, saying the spread of the Omicron variant has not yet stabilized. Spain's Prime Minister Pedro Sanchez said on Monday it may be time to change how it tracks COVID-19's evolution to instead use a method similar to how it follows the flu, because its lethality has fallen. That would imply treating the virus as an "endemic illness", rather than a pandemic.
11th Jan 2022 - Reuters

South African studies suggest Omicron has higher 'asymptomatic carriage'

Preliminary findings from two South African clinical trials suggest the Omicron coronavirus variant has a much higher rate of "asymptomatic carriage" than earlier variants, which could explain why it has spread so rapidly across the globe. The studies - one of which was carried out when Omicron infections were surging in South Africa last month and another which resampled participants around the same time - found a far greater number of people tested positive for the coronavirus but were not showing symptoms compared to previous trials. In the Ubuntu study evaluating the efficacy of Moderna's COVID-19 vaccine in people living with HIV, 31% of 230 participants undergoing screening tested positive, with all 56 samples available for sequencing analysis verified to be Omicron.
11th Jan 2022 - Reuters

Pfizer CEO says Omicron-targeted vaccine is most likely outcome

Pfizer Inc Chief Executive Albert Bourla on Monday said a redesigned COVID-19 vaccine that specifically targets the Omicron coronavirus variant is likely needed and his company could have one ready to launch by March. Bourla said Pfizer and partner BioNTech SE are working on both an Omicron-targeted vaccine version as well as a shot that would include both the previous vaccine as well as one targeted at the fast-spreading variant. "I think it is the most likely scenario," Bourla said, speaking at J.P. Morgan's annual healthcare conference, which is being held virtually this year. "We're working on higher doses. We're working different schedules. We're doing a lot of things right now, as we speak."
11th Jan 2022 - Reuters

PharmaMar shares soar after drug study suggests efficacy against Omicron

Shares in PharmaMar jumped almost 20% on Tuesday after the Spanish drugmaker said lab trials suggested its Plitidepsin drug was effective against the main COVID-19 variants, including the highly contagious Omicron. Results from in-vitro tests published in the Life Science Alliance journal showed that Plitidepsin, also known as Aplidin, had a potent antiviral effect in all variants and decreased the viral load detected in animal lung tissue by 99%, the company said. The same paper also included previously published positive effects in Phase I and II clinical trials carried out on patients who were hospitalised with COVID-19.
11th Jan 2022 - Reuters

Too soon to treat COVID-19 like flu as Omicron spreads - WHO

That would imply treating the virus as an endemic illness, rather than a pandemic, without recording every case and without testing all people presenting symptoms. But that is "a way off", WHO's senior emergency officer for Europe, Catherine Smallwood, said at the briefing, adding that endemicity requires a stable and predictable transmission. "We still have a huge amount of uncertainty and a virus that is evolving quite quickly, imposing new challenges. We are certainly not at the point where we are able to call it endemic," Smallwood said. "It may become endemic in due course, but pinning that down to 2022 is a little bit difficult at this stage."
11th Jan 2022 - Reuters

Repeat Covid Booster Shots Risk Overloading Immune System, EU Regulators Warn

European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune system and may not be feasible. Repeat booster doses every four months could eventually weaken the immune system and tire out people, according to the European Medicines Agency. Instead, countries should leave more time between booster programs and tie them to the onset of the cold season in each hemisphere, following the blueprint set out by influenza vaccination strategies, the agency said.
11th Jan 2022 - Bloomberg

Pfizer COVID vaccine 91% effective against inflammatory syndrome

Among 12- to 18-year-old hospitalized COVID-19 patients, two doses of the Pfizer/BioNTech vaccine was 91% effective in preventing the rare but serious coronavirus-related multisystem inflammatory syndrome in children (MIS-C), according to a US study published late last week in Morbidity and Mortality Weekly Report. In the first real-world evaluation of the Pfizer vaccine's effectiveness against MIS-C, a team led by Centers for Disease Control and Prevention (CDC) researchers compared the odds of COVID-19 vaccination in 102 adolescent MIS-C patients and 181 controls at 24 sites. Controls included 90 COVID-19–negative patients and 91 MIS-C–negative patients from Jul 1 to Dec 9, 2021, after the emergence of the more virulent Delta (B1617.2) variant but before the even more highly transmissible Omicron (B.1.1.529) strain. Median participant age was 14.5 years, and 58% had one or more underlying medical conditions. About 36% of controls and 5% of COVID-19 patients were fully vaccinated at least 28 days before hospitalization.
11th Jan 2022 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Jan 2022

View this newsletter in full

T Cells Triggered by Common Cold Fend Off Covid in Study

High levels of protective immune cells that fight some common colds also made people less likely to contract Covid-19 in a study. Researchers found higher levels of T cells against certain colds in people who didn’t develop Covid while living with someone who had the disease, according to a study released Monday by the U.K.’s Imperial College London. The prior illnesses were caused by other coronaviruses related to SARS-CoV-2. The findings, published in the journal Nature Communications, provide further evidence of the protective effects of T cells, an arm of the immune system that’s gaining attention as the pandemic stretches into its third year and new variants like omicron erode vaccine protection.
10th Jan 2022 - Bloomberg

T-cells from common colds can provide protection against COVID-19 - study

Rapid testing for Omicron: is a nose swab enough?

The fast-spreading Omicron variant has made us more reliant on rapid at-home antigen tests to tell us if we have COVID-19. But should we be swabbing our throats as well as our noses? For now, the guidance depends on where you live. Some scientists have said people can transmit Omicron when it has infected their throat and saliva but before the virus has reached their noses, so swabbing the nostrils early in the infection will not pick it up.
10th Jan 2022 - Reuters

Will we ever reach herd immunity to Covid?

n May 2020, we and other scientists predicted that many regions of the world might never reach the herd immunity threshold for Covid-19 – the point at which enough people are immune to infection that transmission begins to slow down. This remains true today, even as vaccines have become accessible in wealthy nations and many people have built up immunity through vaccinations, boosters and previous infections. The herd immunity threshold was commonly misunderstood as a universal target to hit early in the pandemic. But the threshold has always been changeable: it depends on how transmissible the pathogen is, and the behavioural and immunological characteristics of the population in which it is spreading – how much they mix and how easily they are infected.
10th Jan 2022 - The Guardian

Swab throat too when using rapid COVID test, Israel's Health Ministry says

Israel's Health Ministry on Monday instructed people self-testing for COVID-19 to swab their throat as well as their nose when using rapid antigen kits to increase the chances of detecting the Omicron variant. The recommendation goes against the advice of the U.S. Food and Drug Administration, which has said manufacturers' instructions should still be followed and that incorrect use of throat swabs could pose a safety risk. On Israeli Army Radio, Sharon Alroy-Preis, Israel's public health chief, said antigen tests, used widely in the country, are less sensitive than PCR tests in detecting illness.
10th Jan 2022 - Reuters

EU regulator could issue decision on Pfizer COVID-19 pill 'within weeks'

The European Union's drug regulator said on Monday it could issue "within weeks" a decision on whether to approve the use of Pfizer's COVID-19 pill, Paxlovid, after the U.S. drugmaker submitted an application seeking authorisation. The approval sought is for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older, weighing at least 40 kilograms and are at high risk of their illness worsening, the European Medicines Agency
10th Jan 2022 - Reuters

Pfizer CEO unsure on need for fourth dose of COVID-19 vaccine

Avacta pauses sales of COVID-19 antigen test to improve Omicron sensitivity

Britain's Avacta Group is halting sales of its COVID-19 rapid antigen lateral flow test to replace antibodies in the device and boost its ability to detect the Omicron variant, the biotech firm said on Monday, sending its shares plunging nearly 27%. The London-listed company's test, AffiDX, can detect the Omicron variant when the virus is present in high numbers in samples, but tests carried out by Avacta found AffiDX is less sensitive to Omicron at lower viral loads versus other variants.
10th Jan 2022 - Reuters

Novartis in-licenses COVID-19 treatment ensovibep from Molecular Partners

Novartis said it will license in a new drug it has been developing with Molecular Partners to treat COVID-19, the Swiss company said on Monday, after getting positive trial data. Novartis will pay 150 million Swiss francs ($162.92 million) to in-license ensovibep from Molecular Partners to speed up its manufacturing ramp up and get approvals for the drug more quickly. The decision comes after the two companies said they had received positive topline data from a phase 2 study for ensovibep (mp0420), an antiviral therapeutic for COVID-19 that will from now on be developed and manufactured by Novartis.
10th Jan 2022 - Reuters

T-cells from common colds can provide protection against COVID-19 - study

High levels of T-cells from common cold coronaviruses can provide protection against COVID-19, an Imperial College London study published on Monday has found, which could inform approaches for second-generation vaccines. Immunity against COVID-19 is a complex picture, and while there is evidence of waning antibody levels six months after vaccination, T-cells are also believed to play a vital role in providing protection. The study, which began in September 2020, looked at levels of cross-reactive T-cells generated by previous common colds in 52 household contacts of positive COVID-19 cases shortly after exposure, to see if they went on to develop infection.
10th Jan 2022 - Reuters

Qatar Approves Pfizer Boosters for Children Aged 12 to 15 Years

Qatar approved the Pfizer-BioNTech booster coronavirus vaccine for children aged 12 to 15 years as nations fight the spread of the omicron variant. Children who received their second dose more than six months ago are eligible for the booster shots, according to a statement. Recently, the Ministry of Public Health had approved booster doses to those aged 16 and 17 years. Qatar reported 3,056 new confirmed cases among the community and 633 among travelers on Sunday. That is one of the highest daily numbers in the recent past.
10th Jan 2022 - Bloomberg

Cyprus Finds Covid-19 Infections That Combine Delta and Omicron

A strain of Covid-19 that combines delta and omicron was found in Cyprus, according to Leondios Kostrikis, professor of biological sciences at the University of Cyprus and head of the Laboratory of Biotechnology and Molecular Virology. “There are currently omicron and delta co-infections and we found this strain that is a combination of these two,” Kostrikis said in an interview with Sigma TV Friday. The discovery was named “deltacron” due to the identification of omicron-like genetic signatures within the delta genomes, he said. Kostrikis and his team have identified 25 such cases and the statistical analysis shows that the relative frequency of the combined infection is higher among patients hospitalized due to Covid-19 as compared to non-hospitalized patients. The sequences of the 25 deltacron cases were sent to GISAID, the international database that tracks changes in the virus, on Jan. 7.
10th Jan 2022 - Bloomberg

Covid-19 Variant Deltacron Is Real, Scientist Says

A Cypriot scientist defended his assertion that a new strain of Covid-19 exists that combines characteristics of the delta and omicron variants. Other scientists have speculated that Leonidos Kostrikis’s findings are a result of laboratory contamination. But he told Bloomberg in an emailed statement Sunday that the cases he has identified “indicate an evolutionary pressure to an ancestral strain to acquire these mutations and not a result of a single recombination event.”
10th Jan 2022 - Bloomberg

Germany assessing reliability of antibody tests for Omicron - minister

Germany will study how reliable rapid antigen tests are in detecting the fast-spreading Omicron variant of COVID-19, Health Minister Karl Lauterbach said on Sunday. "We do not know exactly how well these tests work for Omicron," Lauterbach said on public broadcasting channel ARD, adding the results of the assessment would become available within the next few weeks. It was clear, however, that "the alternative not to test at all ... would be far too dangerous," said Lauterbach, a scientist and physician.
10th Jan 2022 - Reuters

Pfizer CEO unsure on need for fourth dose of COVID-19 vaccine

Pfizer Inc Chief Executive Officer Albert Bourla said on Monday he was unsure about the need for a fourth dose of COVID-19 vaccine and that a shot targeting the highly contagious Omicron variant would be ready in March. The comments contrasted with those made by Moderna Inc CEO Stephen Bancel, who said last week people could need another shot in the fall of 2022 as the efficacy of boosters was likely to decline over the next few months.
10th Jan 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Jan 2022

View this newsletter in full

COVID-19 infections in children may increase their risk of diabetes: CDC

Children who have had COVID-19 seem to be at increased risk of developing Type 1 or Type 2 diabetes, according to a study by the Centers for Disease Control and Prevention released Friday. Past studies show increased risk in developing diabetes as an adult after recovering from COVID-19. Research in Europe also found a higher rate of diabetes diagnoses among children since the beginning of the pandemic. The study examined two large insurance claim databases across the United States to document the number of diabetes diagnoses among children under 18 who had previously been diagnosed with COVID-19. These children were compared with those who had never been diagnosed with COVID-19.
10th Jan 2022 - The Hill

Pfizer/BioNTech vaccine protects children against rare COVID-19 complication - CDC

Two doses of the Pfizer Inc and BioNTech COVID-19 vaccine are highly protective against a rare but often serious condition in children that causes organ inflammation weeks after COVID-19 infections, a U.S. Centers for Disease Control and Prevention report said on Friday. The vaccine was estimated to be 91% effective in preventing Multisystem Inflammatory Syndrome in Children (MIS-C) in 12- to 18-year-olds, the study said. MIS-C causes inflammation in children in organs including the heart, lungs, kidneys and brain two to six weeks after a mild or asymptomatic infection. The estimate is based on the assessment of 283 hospitalized patients aged 12–18 years at 24 children's hospitals in 20 states between July and early December, when the prevalence of the Delta coronavirus variant was high.
8th Jan 2022 - Reuters on MSN.com

CDC reports record number of child COVID-19 hospitalizations

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky reported Friday that there have been a record number of pediatric hospitalizations due to COVID-19 and announced new isolation guidelines for students, staff and teachers to preserve in-person learning in schools. During a media briefing, Walensky cautioned that pediatric hospitalizations are at the highest point they have ever been during the pandemic, even though they are much lower when compared to adults. She said it’s still not clear if the increase is due to a greater burden of disease in children's communities or their lower rates of vaccination. The increase was seen most in children younger than 4, who are ineligible for vaccination, and the data include those admitted to hospitals for reasons other than COVID-19 who then tested positive.
8th Jan 2022 - The Hill

Study: COVID-19 vaccination may cause temporary, slight change to menstrual cycle

COVID-19 vaccination may cause a temporary change to a person's menstrual cycle, but it appears to be a “small change,” according to a study published on Thursday. The study, published in the Obstetrics and Gynecology journal, examined close to 4,000 people — vaccinated and unvaccinated — and examined menstruation data that individuals entered through an app called Natural Cycles. Researchers then examined the difference between menstruation data before and after individuals received their vaccine doses. For individuals who did not receive the vaccine, researchers looked at six consecutive menstruation cycles. The researchers found that in vaccinated individuals, bleeding was prolonged by a time that amounted to less than one day. However, they concluded that this slight change, while statistically significant, was not clinically significant.
8th Jan 2022 - The Hill

Omicron Study in South Africa Points to End of Acute Pandemic Phase

A South African study from the epicenter of the world’s omicron surge offers a tantalizing hint that the acute phase of the Covid-19 pandemic may be ending. The infection wave moved with “unprecedented speed” and caused much milder illness than earlier strains, a study of patients infected with Covid-19 at a large hospital in the South African city where the first outbreak of the omicron variant was recorded showed. “If this pattern continues and is repeated globally, we are likely to see a complete decoupling of case and death rates,” the researchers said. That suggests “omicron may be a harbinger of the end of the epidemic phase of the Covid pandemic, ushering in its endemic phase.”
7th Jan 2022 - Bloomberg

Moderna CEO expects a second COVID booster will be needed later this year

Moderna Inc.’s CEO expects fully vaccinated people to need an additional COVID-19 booster shot later this year, as the efficacy of the first booster wanes over time. Speaking Thursday at a virtual conference of health-care CEOs held by Goldman Sachs Group Inc., Moderna MRNA, Chief Executive Stephane Bancel said the current booster should be enough to protect people through the winter omicron surge. However, “I will be surprised when we get that data in the coming weeks that it’s holding nicely over time — I would expect that it’s not gonna hold great,” Bancel said in reference to the booster’s strength. “I still believe we’re going to need boosters in the fall of ’22 and forward.” “We have been saying that we believe first this virus is not going away,” Bancel said. “We’re going to have to live with it.” Bancel said the United Kingdom and South Korea have already submitted orders for a second round of boosters.
7th Jan 2022 - MarketWatch

Moderna CEO warns Americans they may need ANOTHER COVID booster in the fall because the shot's effectiveness won't 'hold great' after a few months

Stephane Bancel, the CEO of Moderna, spoke on Thursday at a Goldman Sachs conference of healthcare professionals. Bancel said he expects a second booster shot will be necessary in the fall, as the data from the first boosters is not expected to be strong. Only around a third of Americans have had their booster shot and convincing a COVID-weary population to get a fourth jab is likely to be a struggle Britain and South Korea have already placed orders for a fourth jab, Bancel said His comments echo those of Pfizer's CEO, who said he too expects a fourth jab to be necessary
7th Jan 2022 - Daily Mail

Rapid nose swab tests for COVID may not detect Omicron quickly enough -expert says

Swabbing the nose with a rapid antigen test will not reliably detect the Omicron variant in the first few days of an infection, so manufacturers should seek U.S. approval to allow users to safely collect samples from the throat as well, according to an infectious diseases expert. The U.S. Food and Drug Administration has expressed concerns over the safety of self throat swabbing. People can already transmit Omicron to others when it has infected their throat and saliva but before the virus reaches their nose, so swabbing the nostrils too early in the course of infection will not pick it up, Dr. Michael Mina, formerly of the Harvard T.H. Chan School of Public Health and now chief science officer at eMed, said during a news conference on Thursday.
7th Jan 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Jan 2022

View this newsletter in full

Gavi and India's Bharat discuss possible COVAX use of Covaxin

The Gavi vaccine alliance is in talks with India's Bharat Biotech over potential procurement of the company's Covaxin COVID-19 shot for the COVAX global vaccine distribution programme, a Gavi spokesperson told Reuters on Thursday. "We are in discussion with (Bharat Biotech) as we consider the overall needs of the COVAX portfolio in 2022. However, we have no agreement for supply of Covaxin to COVAX at this time," the spokesperson said in an email.
6th Jan 2022 - Reuters

Indonesia survey finds 85% of population have COVID-19 antibodies

More than 85% of Indonesia's population has antibodies against COVID-19, a government-commissioned survey showed, but epidemiologists warned it was not clear whether this immunity could help contain a fresh wave of coronavirus infections. The survey, conducted between October and December by researchers at the University of Indonesia, found Indonesians had developed antibodies from a combination of COVID-19 infections and vaccinations.
6th Jan 2022 - Reuters

Pandemic may affect infants' brain development; coronavirus can trigger kidney scarring

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Pandemic may be affecting infants' brains Coronavirus infection during pregnancy does not appear to affect infants' brain function, but the pandemic itself may be having an impact, a study published on Tuesday in JAMA Pediatrics suggests.
6th Jan 2022 - Reuters

Vaccines company Valneva sticks to goal of COVID vaccine approvals in Q1

Speciality vaccines company Valneva (VLS.PA) said it was keeping its previous timetable on clinical trials and regulatory submissions for its VLA2001 COVID-19 vaccine candidate, with regulatory approvals targeted in the first quarter of this year. "We continue to believe that our inactivated vaccine candidate could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can," said Valneva chief executive Thomas Lingelbach.
6th Jan 2022 - Reuters

CDC recommends Pfizer's COVID-19 booster for ages 12 to 15

The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it expanded the eligibility of Pfizer Inc and BioNTech SE's booster doses to those 12 to 15 years old. The move came after a panel of outside experts advising the CDC voted earlier to recommend booster shots of the COVID-19 vaccine be made available for ages 12 to 15.
6th Jan 2022 - Reuters

Pfizer Covid Booster Gets CDC Panel’s Backing for Use in Teens

U.S. public health advisers said vaccinated teens should get a Covid-19 booster shot from Pfizer Inc. and BioNTech SE, an important step in efforts to expand immunizations and keep schools open. The panel of outside experts convened by the Centers for Disease Control and Prevention voted to 13 to 1 to recommend the booster shot for people ages 12 to 17 who received their second dose at least five months earlier. CDC Director Rochelle Walensky endorsed the recommendation, making it official.
6th Jan 2022 - Bloomberg on MSN.com

Containing Covid-19 requires rapid tests that are highly sensitive to infections. Why is the FDA asking for something different?

With rapid testing becoming a key tool in the fight against Covid-19, in a mid-October call with the White House I offered to sell my Covid testing company — recently valued at $99.8 million — to the government for just $1. As an alternative, I also offered to sell the government our test at cost. My company, Global Diagnostic Systems, had just completed clinical trials showing our rapid Covid-19 home test had 100% sensitivity (meaning no false negatives) and 95% specificity (meaning just 5% false positives). On hearing about this performance, a senior White House official told me, “Apply to the FDA ASAP.”
6th Jan 2022 - STAT News

Study raises doubts about rapid Covid tests’ reliability in early days after infection

A new study raises significant doubts about whether at-home rapid antigen tests can detect the Omicron variant before infected people can transmit the virus to others. The study looks at 30 people from settings including Broadway theaters and offices in New York and San Francisco where some workers were not only being tested daily but were, because of rules at their workplaces, receiving both the antigen tests and a daily test that used the polymerase chain reaction, or PCR, which is believed to be more reliable. On days 0 and 1 following a positive PCR test, all of the antigen tests used produced false-negative results, even though in 28 of the 30 cases, levels of virus detected by the PCR test were high enough to infect other people. In four cases, researchers were able to confirm that infected people transmitted the virus to others during the period before they had a positive result on the rapid antigen test.
6th Jan 2022 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Jan 2022

View this newsletter in full

Cuba’s vaccine success story sails past mark set by rich world’s Covid efforts

The island nation struggles to keep the lights on but has inoculated 90% of population with home-developed vaccines General Máximo Gómez, a key figure in Cuba’s 19th-century wars of independence against Spain once said: “Cubans either don’t meet the mark – or go way past it.” A century and a half later, the aphorism rings true. This downtrodden island struggles to keep the lights on, but has now vaccinated more of its citizens against Covid-19 than any of the world’s major nations. More than 90% of the population has been vaccinated with at least one dose of Cuba’s homegrown vaccines, while 83% have been fully inoculated. Of countries with populations of over a million, only the United Arab Emirates has a stronger vaccination record.
5th Jan 2022 - The Guardian

Omicron estimated to be 95.4% of coronavirus variants in U.S. - CDC

The Omicron variant was estimated to be 95.4% of the coronavirus strains circulating in the United States as of Jan. 1, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday. The variant has swiftly spread across the country since its detection on Dec. 1, replacing Delta as the dominant strain and sparking a new wave of infections that pushed daily cases near the 1 million mark on Monday. The CDC said the variant accounted for an estimated 77% of cases in the week ended Dec. 25, up from the 58.6% projection it had disclosed last week.
5th Jan 2022 - Reuters

COVID case counts may be losing importance amid omicron

The explosive increase in U.S. coronavirus case counts is raising alarm, but some experts believe the focus should instead be on COVID-19 hospital admissions. And those aren’t climbing as fast. Dr. Anthony Fauci, for one, said Sunday on ABC that with many infections causing few or no symptoms, “it is much more relevant to focus on the hospitalizations as opposed to the total number of cases.” Other experts argue that case counts still have value. As the super-contagious omicron variant rages across the U.S., new COVID-19 cases per day have more than tripled over the past two weeks, reaching a record-shattering average of 480,000. Schools, hospitals and airlines are struggling as infected workers go into isolation.
5th Jan 2022 - The Associated Press

Fourth COVID-19 vaccine dose boosts antibodies five-fold in Israeli study, PM says

A fourth dose of COVID-19 vaccine boosts antibodies five-fold a week after the shot is administered, Israeli Prime Minister Naftali Bennett said on Tuesday, citing preliminary findings of an Israeli study. "A week into the fourth dose, we know to a higher degree of certainty that the fourth dose is safe," Bennett said at Sheba Medical Center, which is giving second booster shots in a trial among its staff amid a nationwide surge in Omicron variant infections.
4th Jan 2022 - Reuters

Novavax gathers its COVID-19 vaccine data for long-delayed FDA filing

Novavax spent much of 2021 working to file its COVID-19 vaccine with U.S. regulators but falling short of its own deadlines. As the year came to a close, the company celebrated the fact that it was nearly there. Friday, Novavax said it "completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request." This step is not an official emergency use application. Novavax plans to complete that process by the end of this month, the company said. The news comes after a 2021 filled with missed deadlines for the Gaithersburg, Maryland-based biotech. The company originally hoped to file for an EUA by 2021's second quarter, but later pushed that deadline to the third quarter thanks to a manufacturing issue. By October, Novavax said it was eyeing an end-of-year deadline to submit its "complete regulatory package" to the FDA
4th Jan 2022 - FiercePharma

Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US

With two COVID-fighting antiviral pills now on tap, the U.S. government is calling for a second helping of Pfizer’s treatment. The U.S. has doubled its order for Pfizer’s COVID-19 antiviral Paxlovid from 10 million courses to 20 million, the company said Tuesday. At the same time, the government aims to speed up the delivery of those treatments, a senior Biden administration official told Fox News. Roughly 10 million treatment courses of the antiviral, also known as nirmatrelvir tablets and ritonavir tablets, are set for delivery by the end of June, Pfizer said in a release. The remaining 10 million courses are pegged for delivery by the end of September, Pfizer said.
4th Jan 2022 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Jan 2022

View this newsletter in full

Why are so many vaccinated people getting COVID-19 lately?

Why are so many vaccinated people getting COVID-19 lately? A couple of factors are at play, starting with the emergence of the highly contagious omicron variant. Omicron is more likely to infect people, even if it doesn’t make them very sick, and its surge coincided with the holiday travel season in many places. People might mistakenly think the COVID-19 vaccines will completely block infection, but the shots are mainly designed to prevent severe illness, says Louis Mansky, a virus researcher at the University of Minnesota. And the vaccines are still doing their job on that front, particularly for people who’ve gotten boosters.
4th Jan 2022 - The Associated Press

JCVI to consider expanding Covid vaccine rollout to all primary-age school children

Experts on the Joint Committee on Vaccination and Immunisation (JCVI) will be considering whether to expand the Covid jabs programme to all primary-age school children as part of their work, the Prime Minister’s official spokesman said. The Pfizer/BioNTech coronavirus vaccine was approved for use in vulnerable primary school children in December. The JCVI updated its advice after the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the jab for five to 11-year-olds following a robust review of safety data. The Prime Minister’s spokesman said: “Obviously this is something the JCVI would keep under constant review. “They only relatively recently made that decision to move to vulnerable children.
4th Jan 2022 - Wales Online

Multivariant Covid-19 vaccine booster shows promise, early trial data suggests

A Covid vaccine booster aimed at tackling multiple variants shows promise in inducing a comprehensive immune response, early data suggests. The first results of a phase one trial, launched in Manchester in September 2021, reveal the jab has strong levels of neutralising antibodies. They are similar to approved mRNA vaccines (like Pfizer BioNTech and Moderna), but at up to a 10-fold lower dose in the first 10 individuals, the research indicates.
4th Jan 2022 - The Independent

50-second Covid test designed for use in schools and airports submitted to UK regulator for approval

A 50-second Covid-19 test that has been designed for use in schools, airports and at entertainment events has been submitted to the UK’s medicines regulator for approval, i has learned. The testing device, which is portable and around the size of a desktop-computer, is able to detect Covid infected particles in saliva samples in under a minute, according to creator Kidod Science and Technology. The firm claims it can provide results comparable to a PCR test and that it could be approved by the Medicines and Healthcare products Regulatory Agency (MHRA) within weeks.
4th Jan 2022 - iNews

COVID-19: Worst of the pandemic is 'absolutely behind us', says scientist behind Oxford/AstraZeneca vaccine

Speaking a year on from the first time the AstraZeneca vaccine was administered to a member of the public, Professor Sir Andrew Pollard says: "The worst is absolutely behind us. We just need to get through the winter."
4th Jan 2022 - Sky News

FDA clears Pfizer, BioNTech COVID booster for younger teens

The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of Pfizer and BioNTech’s Comirnaty shot as it tries to keep the Omicron variant under control. The US regulator has also reduced the time between completion of the first two doses of Comirnaty and a third dose to five months from six as a wave of new COVID-19 cases caused by Omicron has started washing over the country. That’s still longer than some other countries, including the UK which has pared down the time between the second and third doses to three months. The number of new COVID-19 cases in the US has doubled in the last few days to an average of around 418,000 a day, according to Reuters, while figures suggest there were more than a million new cases in the country yesterday, the highest number recorded since the start of the pandemic.
4th Jan 2022 - Pharmaphorum

WHO sees more evidence that Omicron causes milder symptoms

More evidence is emerging that the Omicron coronavirus variant is affecting the upper respiratory tract, causing milder symptoms than previous variants and resulting in a "decoupling" in some places between soaring case numbers and low death rates, a World Health Organization official said on Tuesday. "We are seeing more and more studies pointing out that Omicron is infecting the upper part of the body. Unlike other ones, the lungs who would be causing severe pneumonia," WHO Incident Manager Abdi Mahamud told Geneva-based journalists.
4th Jan 2022 - Reuters

Israeli study finds fourth COVID-19 vaccine dose boosts antibodies five-fold, PM says

Australia regulator to review price hike in COVID-19 antigen tests

Australia's antitrust regulator said on Tuesday it has contacted suppliers of COVID-19 rapid antigen test kits to examine pricing pressures in the market, as calls grow louder for the government to make the tests free amid a severe shortage of the kits. The Australian Competition and Consumer Commission (ACCC) said it will review information received from suppliers, retailers and the public to determine any potential misconduct. Australia approved more than a dozen rapid antigen test kits and a majority of them are from China.
4th Jan 2022 - Reuters

Covid Science: Virus leaves antibodies that may attack healthy tissues

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Coronavirus leaves survivors with self-attacking antibodies Months after recovering from SARS-CoV-2 infection, survivors have elevated levels of antibodies that can mistakenly attack their own organs and tissues, even if they had not been severely ill, according to new findings.
4th Jan 2022 - Reuters

Dr Reddy's to launch generic COVID-19 Merck drug at about 50 cents a pill

Indian drugmaker Dr Reddy's Laboratories Ltd will launch its generic version of Merck's antiviral COVID-19 pill, molnupiravir, and price it at 35 rupees per capsule, a company spokesperson said on Tuesday. The overall cost for a patient treated with a 5-day course of 40 capsules of the generic drug, to be sold under brand name 'Molflu', will come up to 1,400 rupees ($18.77). In comparison, the treatment with Merck's pill in the United States costs $700. "Molflu is expected to be available from early next week in pharmacies throughout (India) with particular focus on states with high caseload of COVID-19," the company spokesperson said.
4th Jan 2022 - Reuters

COVID-19 vaccination during pregnancy not linked to complications at birth -U.S. study

COVID-19 vaccination during pregnancy was not associated with preterm delivery or underweight newborns, in a study published by the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday. Rates of preterm birth were 4.9% among more than 10,000 women who received at least one dose of a COVID-19 vaccine, compared to 7.0% for roughly 36,000 unvaccinated women, researchers said on Tuesday in The CDC's Morbidity and Mortality Weekly Report. The difference was not deemed to be statistically significant.
4th Jan 2022 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Jan 2022

View this newsletter in full

Omicron Surge Stymies Public-Transit Systems

Public-transit services in New York and other cities are being interrupted, as the Omicron variant of Covid-19 continues to drive staffing shortages. Service on several New York City subway and bus lines was partially suspended Monday. An MTA spokesman said hundreds of employees have been out sick in recent days. He declined to give an exact number or say how many workers have tested positive for Covid-19, adding that the agency doesn’t track specific illnesses. MTA ridership is down about 50% compared with pre-pandemic levels, New York City Transit Interim President Craig Cipriano said. The MTA is currently running over 90% of the buses and trains it typically operates, he said. Mr. Cipriano said that the MTA has contingency plans that outline service tweaks in case of staff shortages on any given day.
3rd Jan 2022 - The Wall Street Journal

Omicron evades immunity better than Delta, Danish study finds

The Omicron coronavirus variant is better at circumventing vaccinated peoples' immunity than the Delta variant, according to a Danish study published last week, helping explain why Omicron is spreading more rapidly. Since the discovery of the heavily mutated Omicron variant in November, scientists have been racing to find out whether it causes less serious disease and why it appears more contagious than the previously dominating Delta variant.
3rd Jan 2022 - Reuters

U.S. Covid-Test Positives Suggest Case Numbers Are Undercounted

The U.S. is reporting record Covid-19 infections, but the true tally may be significantly higher. Average daily cases reached about 405,000 in the past week, about 60% higher than the previous U.S. peak in January 2021, according to Johns Hopkins University data. But the numbers of tests reported by states are still running below their 2021 highs. Meanwhile, the rate of positives among the polymerase chain reaction (PCR) tests is at 17%, the highest since April 2020. In New York City, one in three tests are coming back positive, according to data as of Dec. 31.
3rd Jan 2022 - Bloomberg

Omicron Cases Are Hitting Highs, But New Data Puts End in Sight

A string of new studies has confirmed the silver lining of the omicron variant: Even as case numbers soar to records, the numbers of severe cases and hospitalizations have not. The data, some scientists say, signal a new, less worrying chapter of the pandemic. “We’re now in a totally different phase,” said Monica Gandhi, an immunologist at the University of California, San Francisco. “The virus is always going to be with us, but my hope is this variant causes so much immunity that it will quell the pandemic.”
3rd Jan 2022 - Bloomberg on MSN.com

U.S. FDA authorizes Pfizer's COVID-19 booster for 12- to 15-year-olds

The U.S. Food and Drug Administration on Monday authorized the use of a third dose of the Pfizer (PFE.N) and BioNTech COVID-19 vaccine for children ages 12 to 15, and narrowed the interval for booster shot eligibility to five months from six. The agency also authorized a third shot for children aged 5 through 11 years who are immunocompromised. The regulatory decisions come with COVID-19 cases surging due to the Omicron variant of the virus and just as many workers and school children return from holiday vacations, raising the prospect of overwhelming health systems. Some businesses and schools closed Monday as staff called in sick.
3rd Jan 2022 - Reuters

Virus leaves antibodies that may attack healthy tissues; B cell antibodies weakened, not defeated by Omicron

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Coronavirus leaves survivors with self-attacking antibodies. Months after recovering from SARS-CoV-2 infection, survivors have elevated levels of antibodies that can mistakenly attack their own organs and tissues, even if they had not been severely ill, according to new findings.
3rd Jan 2022 - Reuters

Israel Gives Fourth 4th Shot of Covid Vaccine

Israel will start offering a fourth dose of the coronavirus vaccine to people aged 60 and over, becoming the first country in the world to widely disseminate the extra jab to fight off the omicron strain. The fourth dose will also be made available to medical staff who had their last jab at least four months ago, Prime Minister Naftali Bennett said in a press conference on Sunday. Last week, Israel approved the extra shot for people who are immunocompromised, as well as residents of nursing homes and patients in geriatric wards. New daily cases, which topped 5,000 last week in the country of 9.5 million, are expected to quadruple by the end of the week, Bennett said. The caseload could reach as many as 50,000 cases a day, he said, or nearly five times the previous peak. Critical cases remain well below previous records but have started to creep up over the past week.
2nd Jan 2022 - Bloomberg

New Zealand to Reduce Booster Interval to 4 Months from Jan. 5

New Zealand will reduce the interval between the second Covid-19 vaccine dose and a booster shot to four months from six as part of its response to the omicron variant. People aged 18 or older who have had second shots of the vaccine at least four months ago will be eligible for a booster from Jan. 5, the Ministry of Health said in a statement. The shorter interval means that more than 82% of vaccinated people in the country will be eligible for a booster by the end of February, Dr. Ashley Bloomfield, director general of health, said in the statement. Over 70% of people who were eligible for a booster in 2021 have already had the shot, according to the statement.
1st Jan 2022 - Bloomberg

Omicron hospitalisation risk around one third of Delta, UK analysis shows

The risk of hospitalisation with the Omicron variant of coronavirus is about one-third that of the Delta variant, according to British analysis of more than a million cases of both types in recent weeks. Britain is experiencing a surge in COVID-19 cases driven by the highly-transmissible Omicron variant, with record daily infections of 189,846 reported on Friday. While hospital admissions have started to rise, the government has said it believes the new variant is milder than the Delta variant.
1st Jan 2022 - Reuters

J&J booster slashes Omicron hospitalisations -S.African study

A booster dose of Johnson & Johnson Inc's (JNJ.N) single-dose COVID-19 vaccine was 84% effective at preventing hospitalisation in South African healthcare workers who became infected as the Omicron variant spread, researchers said on Thursday. The real-world study, which has not been peer-reviewed, was based on a second dose of the J&J vaccine administered to 69,092 workers between Nov. 15 and Dec. 20.
31st Dec 2021 - Reuters

Turkey rolls out its own COVID-19 vaccine as infections surge

Turkey began administering its domestically developed COVID-19 vaccine, Turkovac, at hospitals across the country on Thursday, amid a rapid surge in infections due to the Omicron variant. Turkey has already administered more than 130 million doses of vaccines using shots developed by China's Sinovac and by Pfizer/BioNTech. It also began administering booster shots. Turkovac received emergency use authorisation from Turkish authorities last week, after its launch was beset by delays for months.
31st Dec 2021 - Reuters

Pfizer's COVID-19 shot causes mostly mild side effects in young kids - U.S. CDC

Pfizer Inc and BioNTech SE's COVID-19 vaccine caused mostly mild side effects in children aged 5 to 11 years, according to data published by the U.S. Centers for Disease Control and Prevention on Thursday. The data showed that after the second dose of the vaccine some children reported injection-site pain and other systemic reactions such as fatigue and headache. The CDC said it also received reports of 11 cases of myocarditis, a type of heart inflammation, in children aged 5-11 years who had received the vaccine. Of them, seven had recovered, and four were recovering at the time of the report.
31st Dec 2021 - Reuters

Scientists to test high dexamethasone doses in severely ill COVID-19 patients

British scientists will be studying whether higher doses of a cheap and widely used steroid called dexamethasone could work better for patients with severe COVID-19 compared to the standard low doses, they said on Thursday. Last year, the same scientists conducting the large trial, dubbed RECOVERY, showed that dexamethasone was able to save the lives of COVID-19 patients in what was called a "major breakthrough" in the coronavirus pandemic.
31st Dec 2021 - Reuters

Sinovac COVID-19 shot with Pfizer booster less effective against Omicron - study

Sinovac's two-dose COVID-19 vaccine followed by a booster Pfizer-BioNTech shot showed a lower immune response against the Omicron variant compared with other strains, according to a study by researchers. The study, which has not been peer-reviewed yet, was conducted by researchers from Yale University, the Dominican Republic's Ministry of Health and other institutions.
31st Dec 2021 - Reuters

Britain approves Pfizer's antiviral COVID-19 pill

Britain has approved Pfizer's Paxlovid COVID-19 pill for adults who have mild to moderate infection and are at high risk of their illness worsening, its second easily administered antiviral against the coronavirus. Britain is scrambling to build its defences amid a record surge in COVID-19 cases in the winter season as the Omicron variant of the virus spreads quickly.
31st Dec 2021 - Reuters UK

Novavax Files Final Data on Covid Vaccine to U.S. Regulators

Novavax Inc. submitted the final data package for its Covid-19 vaccine candidate to U.S. regulators, bringing it one step closer to clearance. The submission to the Food and Drug Administration included details on chemistry, manufacturing and controls for the shot known as NVX-CoV2373, Novavax said in a statement. The company expects to file a request for emergency use authorization in one month, in line with the FDA’s guidance around such filings. If authorized, the shot would become the fourth Covid vaccine cleared in the U.S. and the first of its kind. European regulators and the World Health Organization cleared the product this month after months of delays. Novavax has grappled with manufacturing problems despite securing some of the largest funding from the Trump administration in the early stages of the pandemic.
31st Dec 2021 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Dec 2021

View this newsletter in full

Who Invented Covid-19 Vaccines? Drugmakers Battle Over Patents

A high-stakes legal battle is taking shape over lucrative patent rights for Covid-19 vaccines, with drug companies pitted against each other and government and academic scientists over who invented what. The U.S. government and Moderna Inc., MRNA whose collaboration led to one of the most widely used shots, have fought over who discovered a key component and owns its rights. Meantime, Pfizer Inc. PFE and BioNTech SE, makers of another leading vaccine, are in a patent battle with a smaller company, and some analysts think they could end up facing off against Moderna. At the heart of the disputes: Who can claim to have invented important elements of the Covid-19 vaccines? Hundreds of millions of dollars are at stake. If anyone succeeds in establishing a role in the discovery of the vaccines, Pfizer and Moderna would have to share with others a bigger cut of the tens of billions of dollars in vaccine sales being generated. “It’s scientific credit and money. That’s what people want,” said Jacob Sherkow, a professor who specializes in biotechnology intellectual property at the University of Illinois College of Law. “This is a major biotech invention, for which tens of billions of dollars are riding on the line.”
29th Dec 2021 - The Wall Street Journal

Postal Covid vaccine patch could provide alternative to jabs by delivering protection ‘like a plaster’

Scientists developing a Covid-19 vaccine skin patch say the invention could revolutionise the coronavirus immunisation process by delivering it to people through the post and allowing them to “vaccinate” themselves by simply sticking it on their skin. Experts at Lancaster University have developed a new Covid-19 vaccine which has shown highly promising results in animal trials and they are already working on a nasal spray method of delivery. However, researchers have revealed they are now developing a patch version of the same vaccine which will have exciting implications if it proves successful in trials and is approved.
29th Dec 2021 - iNews

Israeli hospital launches first test of second COVID-19 booster

An Israeli hospital administered fourth COVID-19 vaccine doses to a test group of health workers on Monday, in what it called the first major study into whether a second round of boosters will help contend with the fast-spreading Omicron variant. Results of the trial, likely to be closely watched internationally, will be submitted to Israel's Health Ministry in about two weeks, said a spokesperson for Sheba Medical Centre near Tel Aviv. Israel was the fastest country to roll out initial vaccinations a year ago, and became one of the first to launch a booster programme after observing that immunity waned over time
29th Dec 2021 - Reuters

Israel's Oramed gets Vietnam pre-order for 10 mln COVID-19 vaccine doses

Israel's Oramed Pharmaceuticals said on Wednesday its Oravax Medical unit signed a deal with Vietnam's Tan Thanh Holdings for the pre-order of 10 million doses of its oral COVID-19 vaccine that is in clinical trials. The agreement gives Tan Thanh, a drug distributor, the right to sell Oravax’s oral vaccine in development throughout the Association of Southeast Asian Nations (ASEAN), which includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam, Oramed said.
29th Dec 2021 - Reuters

Omicron May Cut Delta Infections, South African Study Shows

Infection with the omicron coronavirus variant can also strengthen immunity against the earlier delta strain, reducing the risk of severe disease, according to a paper released by South African scientists. While omicron has been shown to be highly transmissible and can evade some antibodies, after two weeks of getting symptoms immunity to subsequent infections from the strain rose 14-fold, according to the authors led by Alex Sigal and Khadija Khan of the Durban, South Africa-based Africa Health Research Institute. A smaller improvement was found against delta, they said. “If we are lucky, omicron is less pathogenic, and this immunity will help push delta out,” said Sigal, who has previously found a two-dose course of Pfizer Inc. and BioNTech SE’s Covid-19 shot as well as a previous infection may give stronger protection against omicron.
29th Dec 2021 - Bloomberg

Covid With Omicron Isn't 'Same Disease,' Oxford Scientist Says

The omicron variant that’s taking the world by storm is not “the same disease we were seeing a year ago,” a University of Oxford immunologist said, reinforcing reports about the strain’s milder nature. The strain first discovered at the end of November appears to be less severe and even patients who do end up in the hospital spend less time there, John Bell, regius professor of medicine at Oxford, said on BBC Radio 4’s Today program. “The horrific scenes that we saw a year ago -- intensive care units being full, lots of people dying prematurely -- that is now history in my view, and I think we should be reassured that that’s likely to continue,” Bell said.
29th Dec 2021 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Dec 2021

View this newsletter in full

Australia records first Omicron death, authorities stick to reopening plan

Australia reported its first confirmed death from the new Omicron variant of COVID-19 on Monday amid its biggest daily surge in infections, but the authorities refrained from imposing new restrictions saying hospitalisation rates remained low. The death, a man in his 80s with underlying health conditions, marked a grim milestone for the country which has had to reverse some parts of a staged reopening after nearly two years of stop-start lockdowns, due to the fresh outbreak. Omicron, which health experts say appears more contagious but less virulent than previous strains, began to spread in the country just as it lifted restrictions on most domestic borders and allowed Australians to return from overseas without quarantine, driving case numbers to the highest of the pandemic.
27th Dec 2021 - Reuters

Unvaccinated 60 times more likely to end up in ICU with Covid, new research says

Unjabbed people who catch Covid are up to 60 times more likely to end up in an intensive care ward than those who have been vaccinated, figures reveal. The startling data also shows the difference between the jabbed and unjabbed needing intensive care is starkest among older people – who are more likely to suffer more seriously from Covid. Figures from the Intensive Care National Audit and Research Centre (ICNARC), which covers hospital units in England, Wales and Northern Ireland, show that between May and November the rate of admission for double-jabbed Covid sufferers in their 60s was just 0.6 cases per 100,000 people per week. But among unjabbed people of the same age the rate was 37.3 per 100,000 per week – equating to a relative risk about 60 times higher
27th Dec 2021 - The Mirror

Latin America Is Now a World Leader in Vaccinations

Latin America, once a hot spot of Covid-19 deaths, now leads the U.S. and much of the world in vaccinations, as supply concerns have eased and health policy makers rush to shield their countries from new variants roiling other regions. Applying a mix of Chinese, European and American vaccines, about 62% of South America’s population has received two shots or the single dose by Johnson & Johnson. That is more than the 60% of Europeans inoculated with two doses, the 56% of people in North America and the 54% in Asia, according to Our World in Data, a pandemic research project at the University of Oxford. Only Australia has fully vaccinated a bigger percentage of its people.
26th Dec 2021 - The Wall Street Journal

India to Vaccinate Teens, Offer Boosters, Modi Says

India will begin vaccinating teenagers from the ages of 15 to 18 from Jan. 3 and also administer booster vaccine doses for health-care workers a week later, as omicron-fueled Covid-19 cases spike, Prime Minister Narendra Modi said. Citizens who are older than 60 years and suffer from co-morbidities can also get booster shots of Covid vaccines in January, Modi said in a televised national address. “India needs to be vigilant about the spread of the coronavirus,” Modi said, adding that people should not pay attention to rumors nor panic about rising infection numbers. India has so far reported 415 cases of omicron infections from across 17 states, according to the latest data from the federal Health Ministry Saturday. The South Asian nation’s confirmed Covid cases so far total nearly 34.8 million.
26th Dec 2021 - Bloomberg

Vallance hits back at Tory accusations of Omicron fear-mongering

The UK government’s chief scientific adviser has hit back at accusations from Conservative MPs that epidemiological modellers had “spread gloom” about the Omicron variant. Sir Patrick Vallance said it was not the responsibility of the Scientific Advisory Group for Emergencies (Sage) “to take a particular policy stance or to either spread gloom or give Panglossian optimism”. He used an article in the Times to respond to criticism that was widely circulated among Tory MPs and ministers that suggested Sage’s Omicron modelling had been an exercise in fear-mongering. The Spectator’s editor, Fraser Nelson, had a Twitter exchange with the Sage member Graham Medley over the weekend, suggesting ministers asked Sage to model worst-case scenarios. The exchange was reportedly widely shared in the WhatsApp groups of Tory MPs.
24th Dec 2021 - The Guardian

S.Africa Omicron data should not be extrapolated to all countries- Africa CDC

Data from South Africa which suggests the Omicron coronavirus variant is 70% to 80% less severe than Delta should not be extrapolated to all countries, the head of the Africa Centres for Disease Control (CDC) said on Thursday. A South African study published on Wednesday found that people diagnosed with Omicron in the country in October and November were 80% less likely to be admitted to hospital than those diagnosed with another variant in the same period.
24th Dec 2021 - Reuters

CDC cuts quarantine time for healthcare workers amid Omicron surge

Healthcare workers in the United States who test positive for COVID-19 but are asymptomatic can return to work after seven days in isolation, provided they test negative, the Centers for Disease Control and Prevention said on Thursday. The new guidance cuts the quarantine time from a previously recommended 10 days, which the CDC said was in preparation for an anticipated increase in Omicron cases. Omicron now accounts for 73% of coronavirus infections in the United States, the CDC said on Monday. The CDC said the quarantine time can be cut further if there are staffing shortages due to COVID-19, adding that healthcare workers who have been fully vaccinated, including a booster, do not need to quarantine at home following high-risk exposures.
24th Dec 2021 - Reuters

China's Sinovac COVID-19 booster weaker against Omicron- Hong Kong study

Three doses of Sinovac's CoronaVac COVID-19 vaccine do not produce adequate levels of antibodies to fight the Omicron variant of the coronavirus, researchers from Hong Kong said in a statement. Their analysis revealed Pfizer-BioNTech vaccine was more effective, as a third dose of the shot administered after two doses of the same or China's Sinovac vaccine provided "protective levels" of antibody against Omicron. Pfizer and its German partner BioNTech have said their three-shot course was able to neutralise the new Omicron variant in a laboratory test.
23rd Dec 2021 - Reuters

Omicron Study in U.K. Bolsters Evidence of Lower Hospital Risks

Omicron appears to be less severe but more contagious than any other Covid-19 strain to date, a U.K. government study concluded, bolstering research that has shown a lower risk of hospitalization from the fast-spreading variant. People infected with omicron are 50% to 70% less likely than those with delta to be admitted to hospitals, the U.K. Health Security Agency said Thursday. Omicron patients are also 31% to 45% less likely to arrive at emergency departments than those with delta. The agency’s data came with an important caveat: While a booster shot improves protection against omicron, its effectiveness starts to wane more rapidly than with delta and is 15% to 25% lower starting 10 weeks after the third dose. The agency also cautioned that the new variant is so infectious that it could still produce significant numbers of severe cases.
23rd Dec 2021 - Bloomberg

U.S. pauses allocation of Regeneron, Lilly COVID-19 antibodies

The U.S. government has paused the distribution of COVID-19 antibody treatments from Regeneron Pharmaceuticals and Eli Lilly, saying the therapies were unlikely to be effective against the Omicron coronavirus variant. The variant has become the dominant strain in the United States with lightning speed, resurrecting restrictions and stretching the country's testing infrastructure. The halt on the allocation of the therapies will continue until new data emerges on their efficacy, the U.S. Food and Drug Administration and the office of Assistant Secretary for Preparedness and Response said in a joint statement on Thursday
23rd Dec 2021 - Reuters

Australia Brings Forward Booster Shots Amid Omicron Outbreaks

Australia has brought forward implementing third-dose booster shots for Covid-19 as the nation battles outbreaks of the omicron variant. From Jan. 4, Australians will be be able to get their booster shot four months after receiving their second dose, narrowing the current five-months wait time, Health Minister Greg Hunt said in Canberra. From Jan. 31, the gap will be cut again to three months. “These dates have been set out of an abundance of caution to give Australians early continued protection,” Hunt said. About 91% of Australians aged 16 and over have had two jabs, he said.
23rd Dec 2021 - Bloomberg

New U.K. Study Reinforces Conclusion That Omicron Causes Less Severe Disease

People infected with the Omicron variant of coronavirus are between 50% to 70% less likely to be admitted to the hospital than those who caught earlier strains, according to a new U.K. study that adds to a growing body of evidence of Omicron’s reduced severity in populations with high levels of immunity. The analysis from England, published Thursday by the U.K.’s Health Security Agency, follows studies in Scotland and South Africa that also pointed to a substantially lower risk of hospitalization with Omicron than with more established variants, including Delta. Scientists are still unsure how these encouraging findings around hospitalizations will stack up against Omicron’s much increased transmissibility, and ability to partially evade the protection of vaccines. The risk, they say, is the variant could still cause a big wave of hospital admissions simply by infecting many more people.
23rd Dec 2021 - The Wall Street Journal

FDA Authorizes Merck’s Covid-19 Pill for At-Home Treatment

U.S. regulators cleared use of a Covid-19 pill from Merck and partner Ridgeback Biotherapeutics LP, the latest easy-to-use therapy that infected people can take to keep out of the hospital. The authorization by the U.S. Food and Drug Administration permits doctors to prescribe the drug, called molnupiravir, to adults at high risk of severe disease shortly after they develop mild to moderate symptoms. The FDA recommended using the Merck drug only if other authorized drugs aren’t available and medically appropriate. Health experts have raised safety concerns about the Merck drug, which also was less effective in testing than an antiviral from Pfizer Inc. On Wednesday, the FDA cleared the Pfizer pill, Paxlovid, also for people to take at home to try to stay out of the hospital. The authorization by the U.S. Food and Drug Administration permits doctors to prescribe the drug, called molnupiravir, to adults at high risk of severe disease shortly after they develop mild to moderate symptoms. The FDA recommended using the Merck drug only if other authorized drugs aren’t available and medically appropriate. Health experts have raised safety concerns about the Merck drug, which also was less effective in testing than an antiviral from Pfizer Inc. On Wednesday, the FDA cleared the Pfizer pill, Paxlovid, also for people to take at home to try to stay out of the hospital.
23rd Dec 2021 - The Wall Street Journal

COVID: Study suggests AstraZeneca booster works against Omicron

AstraZeneca has said that a third dose of its COVID-19 vaccine “significantly” lifted antibody levels against the Omicron coronavirus variant, citing data from a new laboratory study. Findings from the study, yet to be published in a peer-reviewed medical journal, match those from rivals Pfizer-BioNTech and Moderna, which have also found a third dose of their shots works against Omicron.
23rd Dec 2021 - Al Jazeera English

South African health regulator approves J&J COVID-19 boosters

South Africa's health regulator on Thursday approved the use of Johnson & Johnson vaccine for a second dose or booster, paving the way for the shot widely used in South Africa to shore up protection against the Omicron variant. The country already announced in December that it was preparing to offer people booster doses of both the Pfizer and J&J shots, but it did not specify when J&J boosters would be available. The South African Health Products Authority (SAPHRA) said in a statement on Thursday that it had approved J&J shots for use as a second dose or booster at least two months after the completion of the person's primary vaccination, with either J&J's single-shot course or another approved mRNA COVID-19 vaccine.
23rd Dec 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Dec 2021

View this newsletter in full

Army to announce it has developed a single vaccine that protects from ALL variants of COVID and SARS

Walter Reed Army Institute of Research is set to announce the development of a vaccine that is effective against all COVID and SARS variants. Army researchers at Walter Reed have been working on a vaccine for two years. The Spike Ferritin Nanoparticle COVID-19 vaccine (SpFN) has so far been proven to protect against all existing and potential variants of the viruses. The Omicron COVID variant has been quickly spreading across the world and now accounts for 73 per cent of all new diagnoses in the US. Some states including New York and neighboring New Jersey say the super-infectious variant is behind 90 per cent of positive cases there
23rd Dec 2021 - Daily Mail

Omicron COVID symptoms milder than Delta in UK, early data suggests

Britons who fall ill with the Omicron variant of the coronavirus are less likely to become severely sick than those who contract Delta, U.K. government scientists are set to say in early real-world data on the severity of the disease. But while Omicron cases in the U.K. seem milder overall, the U.K. Health Security Agency (UKHSA) has found it is not necessarily mild enough to avoid large numbers of hospitalizations, according to the data, which is due to be published before Christmas and was previewed by POLITICO's London Playbook. The UKHSA found evidence that for those who do become severely ill with Omicron, there is still a high chance of hospitalization and death. The scientists also confirmed that the transmissibility of Omicron is very high, meaning that even though it is milder, infections could rocket to the point large numbers could still end up in hospital. The UKHSA is also expected to conclude that while two doses of a COVID vaccine are not enough to offer strong protection against Omicron, a booster dose does significantly reduce the chance of both symptomatic infection and hospitalization, London Playbook reported. A UKHSA spokesperson said they would not comment on unpublished data.
22nd Dec 2021 - POLITICO

Pfizer to provide 2.5 mln additional doses of its COVID-19 pill to UK

Pfizer Inc said on Wednesday it will provide an additional 2.5 million doses of its COVID-19 pill Paxlovid to the United Kingdom. A total of 2.75 million doses of the pill are expected to be delivered to the UK through 2022, the drugmaker said.
22nd Dec 2021 - Reuters

France cancels order for Merck's COVID-19 antiviral drug

France has cancelled its order for Merck & Co's COVID-19 antiviral drug following disappointing trial data and hopes instead to receive Pfizer's competing drug before the end of January, the health minister said on Wednesday. France is the first country to publicly say it has cancelled an order for the Merck treatment after the company released data in late November suggesting its drug was markedly less effective than previously thought, reducing hospitalisations and deaths in its clinical trial of high-risk individuals by about 30%. "The latest studies weren't good," Olivier Veran told BFM TV. A spokesperson for Merck said the country's planned purchase did not take place after the French health authority refused to authorise the pill earlier this month.
22nd Dec 2021 - Reuters

Turkey's domestic COVID-19 vaccine receives emergency use authorisation -minister

Turkey's domestically developed COVID-19 vaccine, Turkovac, has received emergency use authorisation by Turkish authorities and will be open to use from next weekend, Health Minister Fahrettin Koca said on Wednesday. Turkey began developing Turkovac this year, but the launch date for the vaccine has been beset by delays. President Tayyip Erdogan has said Turkey would make the shot available globally.
22nd Dec 2021 - Reuters

JCVI recommends Covid jabs for vulnerable children aged 5-11

Hundreds of thousands of clinically vulnerable five- to 11-year-olds are to be offered Covid vaccines for the first time, with some scientists calling for the programme to be extended to the whole age group before the new UK school term. The Joint Committee on Vaccination and Immunisation (JCVI) has recommended vaccinations for about 330,000 younger children at clinical risk, and also those living with someone who is immunosuppressed. They will be offered two doses of the Pfizer vaccine – in 10-microgram amounts, a third of the quantity used for adults – with a gap of eight weeks. A parallel announcement will expand the booster programme to more teenagers, including 16 and 17-year-olds.
22nd Dec 2021 - The Guardian

U.K. Allows Pfizer Covid Shot for At-Risk Children Aged 5 to 11

The U.K. vaccines panel cleared the Pfizer Inc. Covid-19 shot for use in vulnerable young children in a bid to widen vaccination coverage against the omicron variant. The Joint Committee on Vaccination and Immunisation changed its advice to allow at-risk children aged 5 to 11 years old to become eligible for two doses of the Pfizer-BioNTech vaccine. Each inoculation will be one-third of the dose used for those aged 12 and above. Only children in a clinical risk group or who are a household contact of an immunosuppressed person are eligible for vaccination at this stage. The JCVI said it would issue advice on shots for less vulnerable children “in due course.”
22nd Dec 2021 - Bloomberg

France Scraps Order for Merck Antiviral Pill, Looks to Pfizer

France canceled an order for Merck & Co.’s antiviral pill on disappointing test results and is now counting on a treatment from Pfizer Inc., according to the country’s health minister. “We had to cancel because the last studies weren’t good,” Olivier Veran said Wednesday in an interview on BFM TV. “It cost us nothing.” Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for the coronavirus. Veran had initially expressed optimism about the Merck drug. The treatments, in which patients take pills at home over several days, could ease the burden on stretched hospitals as infections are soaring in the U.S. and Europe.
22nd Dec 2021 - Bloomberg

Is It Safe to Fly Right Now? Omicron May Double Infection Risk on Planes: IATA

Aircraft passengers are twice or even three times more likely to catch Covid-19 during a flight since the emergence of the omicron variant, according to the top medical adviser to the world’s airlines. The new strain is highly transmissible and has become dominant in a matter of weeks, accounting for more than 70% of all new cases in the U.S. alone. While hospital-grade air filters on modern passenger jets make the risk of infection much lower on planes than in crowded places on the ground such as shopping malls, omicron is rapidly spreading just as more travelers take to the skies for year-end holidays and family reunions.
22nd Dec 2021 - Bloomberg

S.African study offers Omicron hope as nations reimpose curbs

South African data offered a glimmer of hope on Wednesday about the severity of the Omicron coronavirus variant, but World Health Organization officials cautioned that it was too soon to draw firm conclusions as the strain spread across the globe. With the second Christmas of the pandemic days away, countries imposed new restrictions on their citizens while worrying about the damage the variant might inflict on their economies. Plans for Christmas parties and celebrations were wiped out from London to New Delhi amid the uncertainty.
22nd Dec 2021 - Reuters

Pharma 2022 forecast: With omicron extending the pandemic, how will biopharma respond to COVID?

Well, thanks to omicron, here we are again, asking many of the same questions and with renewed anxiety about the future. At least now we know the drill. “I see COVID continuing to have new variants and coming back each season,” Cantor Fitzgerald’s Grace Chen told Fierce Pharma. We also know what questions to ask. Is omicron more contagious? Will vaccines and treatments be effective? Are we destined for a return of restrictions and lockdowns? And, after omicron, what’s next? Are we simply on a coronavirus hamster wheel, with many more variants yet to contend with? As the pharmaceutical industry approaches 2022, there is some comfort knowing that a blueprint is in place to respond to the pandemic—and one that will allow business to continue. But what about those best-laid plans based on the belief that the pandemic would transition into an endemic in 2022?
22nd Dec 2021 - FiercePharma

A computational biologist weighs in on Omicron, the future of vaccines, and the CDC’s variant forecast

What do the data so far tell us about Omicron and whether it causes milder disease than previous Covid-19 variants? What can we expect to see as Omicron infections crash up against the country’s health care system? Why do Omicron waves seem to decline so quickly after scaling such heights? We don’t know. So we asked Trevor Bedford, a computational biologist at the Fred Hutchinson Cancer Research Center in Seattle, for his thoughts. Bedford believes that while there may be something intrinsically different about the way Omicron viruses attack human bodies, much of what is being reported in terms of mildness of cases can be explained by the fact that many people being infected have some immunity to the SARS-CoV-2 virus, either because they were previously infected or they’ve been vaccinated.
22nd Dec 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Dec 2021

View this newsletter in full

Covid US: Fauci says Omicron spreads at 'unprecedented' speed and cases will DOUBLE every two days

Dr Anthony Fauci, the nation's top infectious disease expert, said Tuesday that the Omicron COVID-19 variant is spreading at an 'unprecedented' speed. The CDC revealed on Monday night that the new variant accounts for 73% of new cases in the U.S., and is now the nation's dominant strain. It only accounted for 12% of cases last week. Fauci says that while cases of the variant are usually more mild, the speed of which it spreads could still cause massive issues for the U.S. healthcare system. The first U.S. based Omicron COVID-19 death was recorded on Monday in an unvaccinated Texas man between ages 50 and 60. More than 250,000 COVID-19 cases were recorded on Monday, the first time since early September the mark was reached. In New York and New Jersey, the Midwest, the Southeast, the Gulf Coast, and the Northwest, the Omicron variant now account for more than 90 percent of new cases
21st Dec 2021 - Daily Mail

EU drug regulator: COVID-19 boosters help restore some protection against Omicron

The European Union's drug regulator said early data shows a booster dose of a COVID-19 vaccine helps restore some protection against the new Omicron variant, although there is no evidence yet that tweaks to existing shots will be necessary. "Data is showing that indeed there is a drop in the ability of the (COVID-19) vaccine to exert good neutralisation for Omicron," said Marco Cavaleri, head of biological health threats and vaccines strategy at the European Medicines Agency (EMA). "A booster dose is indeed able to restore quite (a) high level of protection from symptomatic disease," he said later in the same briefing.
21st Dec 2021 - Reuters

Belgian researchers warn against holiday reliance on COVID antigen tests

Belgian researchers on Tuesday issued a pre-holiday warning against over-reliance on COVID-19 rapid antigen tests, saying they believed the breath of people infected with the disease had high levels of virus in the first two days after an infection -- a period when many antigen tests were negative. The organizations involved said they were communicating their findings in advance of a peer-reviewed publication in the interests of public health, as many families may be planning to use antigen tests as a way of screening for illness before family gatherings. "A negative rapid antigen test just before a meeting offers no guarantee to protect others, in particular when the person tested has recently been exposed to the virus," said Emmanuel Andre, a microbiologist at KU Leuven, which conducted the research together with UZ Leuven, a university hospital, and IMEC, a microelectronics think-tank.
21st Dec 2021 - Reuters

Long Covid Patients Report Vibrations, Tremors: ‘My Body Is Moving Inside, It’s Jolting’

Ms. Morrison, a 50-year-old transplant coordinator at a New Orleans hospital, says the sensations are among the symptoms she has experienced since testing positive for Covid-19 in March 2020. Long Covid patients—estimated to be 10% to 30% of people who have had Covid-19—experience a range of symptoms including fatigue, cognitive problems, shortness of breath and sensory issues, such as numbness and tingling. Internal vibrations and external tremors are less common and have received less attention. Yet a study this summer from the Patient-Led Research Collaborative, a group of long Covid patients that conduct research, found that roughly 40% of patients reported experiencing tremors and 30% vibrating sensations.
21st Dec 2021 - The Wall Street Journal

Omicron is more transmissible, but is it really milder?

The emergence of the Omicron variant has changed the course of the pandemic once again. Just as many countries were beginning to enjoy easing of restrictions and many families were planning for Christmas, the new variant arrived, forcing governments to scramble over measures to help curb its spread. Although it is widely accepted the Omicron variant did not originate in South Africa, because it had the technology and sense of responsibility to report the new variant, it has unfairly had the most severe travel restrictions imposed upon it by other countries. South African doctors and politicians have been critical of the global response, feeling it too harsh and disproportionate to the threat posed by the Omicron variant.
21st Dec 2021 - Al Jazeera English

Covid-19 Pills Expected to Win FDA Authorization This Week

The U.S. Food and Drug Administration is poised to authorize a pair of pills from Pfizer Inc. and Merck & Co. to treat Covid-19 as soon as this week, according to people familiar with the matter -- a milestone in the fight against the pandemic that will soon expand therapies for the ill. An announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change. Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for the coronavirus. The treatments, in which patients take a series of pills at home over several days, could ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S.
21st Dec 2021 - Bloomberg

Pardes to go public, says COVID-19 antiviral pill does not need booster

Pardes Biosciences on Tuesday said early human testing of its experimental COVID-19 antiviral pill supports its potential as a standalone treatment and announced plans to go public by merging with a special purpose acquisition company. If the drug, PBI-0451, proves effective in later-stage testing, it could have an advantage over similar medicines that need to be taken with a second, booster medication, such as Pfizer Inc's (PFE.N) two-drug antiviral regimen, Paxlovid, now under review by the U.S. Food and Drug Administration. Pardes said it expects to complete its current Phase I study in healthy volunteers early next year. It aims to begin by mid-year a larger trial that could be used to seek regulatory approval for the COVID-19 antiviral pill.
21st Dec 2021 - Reuters

German COVID experts push for immediate contact limits

Germany will introduce new measures to curb the spread of COVID-19 before New Year's Eve, including limiting private gatherings for vaccinated people to a maximum of 10 people, Chancellor Olaf Scholz said on Tuesday. Stopping well short of a nationwide lockdown, Scholz also agreed with the premiers of Germany's 16 states to close clubs and discos and to only allow big events, including soccer matches, without spectators.
21st Dec 2021 - Reuters

Moderna could be ready to develop Omicron booster in weeks - CEO

COVID-19 vaccine maker Moderna (MRNA.O) does not expect any problems in developing a booster shot to protect against the Omicron variant of the coronavirus and could begin work in a few weeks, Chief Executive Stephane Bancel said in an interview. Moderna hopes to start clinical trials early next year on a vaccine to protect against the fast-spreading Omicron variant but for now is focussing on a booster dose of its current mRNA-1273 vaccine. "It only needs minor adjustments for Omicron. I don't expect any problems," Bancel said in an interview with the Swiss newspaper TagesAnzeiger published on Tuesday.
21st Dec 2021 - Reuters

Omicron cases could hit 200,000 a day next year without tougher restrictions, Doherty modelling warns

Surging Omicron infections will overwhelm the health system unless some restrictions return, according to modelling prepared for national cabinet that also recommends bringing coronavirus vaccine boosters forward. The Doherty Institute modelling predicts that without low-to-medium restrictions such as density and visitor limits, waning vaccine protection against the Omicron variant puts Australia on track to hit about 200,000 cases a day by late January or early February.
21st Dec 2021 - Sydney Morning Herald

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Dec 2021

View this newsletter in full

EU Commission authorises Novavax COVID-19 vaccine

The European Commission authorised on Monday the use of the Novavax COVID-19 vaccine in the European Union. "With five approved vaccines, the EU has a varied portfolio, based both on novel technologies, such as mRNA, and classic ones, like Novavax, which is protein-based," the head of the bloc's executive Commission, Ursula von der Leyen, said on Twitter.
20th Dec 2021 - Reuters

Covid-19 news: Moderna booster stimulates antibodies against omicron

Moderna booster jab leads to 37-fold increase in levels of antibodies against the omicron variant. A booster dose of Moderna’s coronavirus vaccine appears to increase neutralising antibodies against the coronavirus, the company announced on Monday. A 50mg dose of the booster – the dose authorised for use in the UK and US – was found to stimulate a 37-fold increase in antibodies against omicron. A 100mg dose of the booster saw an 83-fold increase in antibodies. The 37-fold increase “should provide some good level of protection as we go into the holiday season”, Paul Burton, Moderna’s chief medical officer, told the Washington Post. The findings are based on antibody levels measured in the blood of 20 people 29 days after receiving a third dose of the vaccine. Moderna announced the results in a press release – the study has not yet been published or peer reviewed.
20th Dec 2021 - New Scientist

Kremlin convinced WHO will approve Sputnik V vaccine within months -Ifax

The Kremlin is convinced that the World Health Organization (WHO) will recognise Russia's flagship Sputnik V COVID-19 vaccine within a few months, the Interfax news agency cited Kremlin spokesperson Dmitry Peskov as saying on Sunday. The Kremlin on Tuesday said Russia had still not handed over all the information needed for the vaccine to be approved by the WHO because of differences in regulatory standards. "I am deeply convinced that literally within a few months... the WHO will approve Sputnik and it will also then be possible to move forward on this path with the Europeans," Interfax quoted Peskov as saying.
20th Dec 2021 - Reuters

French health regulator approves Pfizer vaccine for 5-11 year olds

France's Haute Autorite de Sante (HAS) health regulator approved the Pfizer-BioNTech COVID-19 vaccine for all children aged 5-11 on Monday. The vaccine, which will be administered in a paediatric formulation when it becomes widely available, showed high efficacy among children, said Lise Alter, one of the doctors charged with the risk evaluation of new drugs. "The HAS suggests that all parents who want it can have their children aged 5 to 11 years vaccinated," she added. Last week France started vaccinating 5-11 year olds with medical conditions that require special protection and ramped up logistics to roll out vaccination of all children in the age group once the HAS approves the move.
20th Dec 2021 - Reuters

New Zealand links 26-year-old man's death to Pfizer COVID-19 vaccine

New Zealand authorities on Monday said they had linked a 26-year-old man's death to Pfizer Inc's COVID-19 vaccine after the person suffered myocarditis, a rare inflammation of the heart muscle, after taking his first dose. The death is New Zealand's second linked to a known but rare side effect from the vaccine after health authorities in August reported a woman had died after taking her doses. "With the current available information, the board has considered that the myocarditis was probably due to vaccination in this individual," a COVID-19 Vaccine Independent Safety Monitoring Board said in a statement.
20th Dec 2021 - Reuters

Bharat Biotech seeks trial for intranasal COVID-19 vaccine booster

Indian vaccine maker Bharat Biotech said on Monday it has submitted an application to the country's drug regulator to conduct a late-stage trial for a booster dose of its intranasal COVID-19 vaccine. Indian COVID-19 vaccine makers are lobbying the government to authorise boosters as supplies have far outstripped demand, but the health ministry said there is no immediate plan to approve boosters and the priority remains complete vaccination of eligible adults. read more "We have submitted phase 3 clinical trial application to DCGI (Drugs Controller General of India)," a Bharat Biotech spokesperson said in a statement, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.
20th Dec 2021 - Reuters

Sinopharm COVID-19 booster weaker against Omicron - study

A COVID-19 booster shot produced by China's Sinopharm had "significantly lower" neutralising activity against the Omicron variant, Chinese researchers said in a paper, although they added the vaccine's efficacy against Omicron remained unclear. The study - conducted by researchers from Shanghai Jiao Tong University and a Shanghai-based lab specializing in respiratory infectious diseases - compared the activity of Sinopharm's booster vaccine against an older coronavirus strainfrom Wuhan. The neutralising antibody activity of a Sinopharm BBIBP-CorV booster against Omicron showed a 20.1-fold reduction, compared with its activity against a Wuhan strain, according to the paper published on Saturday.
20th Dec 2021 - Reuters

Moderna says booster dose of its COVID-19 vaccine appears protective vs. Omicron

Moderna Inc said that a booster dose of its COVID-19 vaccine appeared to be protective against the fast-spreading Omicron variant of the coronavirus in laboratory testing and that the current version of the shot would continue to be its "first line of defense against Omicron." The company said its decision to focus on the current vaccine, mRNA-1273, was driven in part by how quickly the recently-discovered variant is spreading. Moderna said it still plans to develop a vaccine to protect against Omicron specifically and hopes to start clinical trials early next year.
20th Dec 2021 - Reuters

Novavax expected to start delivering COVID-19 shots to EU in first quarter 2022 -EU source

Novavax is expected to start delivering its COVID-19 vaccines to the European Union in the first quarter of 2022, an EU source said, as experts for the region's drug regulator met on Monday to decide whether to approve the shot. The EU Commission had no immediate comment and the U.S. biotech company was not immediately available for comment. The EU source declined to be identified because they were not authorised to speak to the media.
20th Dec 2021 - Reuters

Pharma After EMA recommendation, Novavax's COVID-19 vaccine nears rollout in Europe

In less than a week, Novavax has clinched a second major win in its bid to expand the reach of its COVID-19 vaccine. The European Medicines Agency (EMA) on Monday blessed Novavax’s shot, Nuvaxovid, with a recommendation for conditional marketing authorization in the European Union. The news comes just a few days after the vaccine, also known as NVX-CoV2373, won emergency use listing from The World Health Organization (WHO), teeing up shipments to the agency’s equitable vaccine access scheme COVAX. The shot will carry the Nuvaxovid name if it’s authorized in Europe. Elsewhere, the vaccine has been authorized under the Covovax moniker.
20th Dec 2021 - FiercePharma

For an antiviral researcher, Covid brings a flood of attention — and opportunity

At the heart of the effort to develop these therapies are scientists like Glenn. For them, Covid is a chance to prove that they can make a difference by developing new treatments not just for the current pandemic but also future threats. “We’ve always believed that what we work on is meaningful and can be very impactful, but now the world gets it,” Glenn said. There remain questions about how long the boom times will last. Antiviral researchers have seen interest in their work flare — with the 2003 SARS outbreak, for instance, or the anthrax attacks after Sept. 11, 2001 — only to quickly dissipate. The same could happen with Covid, though many experts are hoping this time is different. “I seriously hope there is a realization that this needs to be a sustained effort,” said Kara Carter, entrepreneur-in-residence at the biotechnology company Evotec and president of the International Society for Antiviral Research. “We’ve already had multiple viral epidemics and pandemics in our lifetimes, and this is not going to stop.”
20th Dec 2021 - STAT News

Facing intense criticism, Moderna pauses bitter dispute with the NIH over Covid-19 vaccine patents

Moderna has halted a rancorous patent dispute with the U.S. government over assigning credit for its Covid-19 vaccine, saying the ongoing quarrel “could interfere with further discussions aimed at an amicable resolution” with the National Institutes of Health. The move comes amid intensifying complaints that many vaccine makers are failing to make their intellectual property available so that still other companies can produce vaccines needed for a global eradication campaign. Moderna, which recently projected $18 billion in vaccine sales this year, has been a particular focus of criticism because U.S. taxpayers provided $2.5 billion to help develop the shot.
19th Dec 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Dec 2021

View this newsletter in full

Pfizer says pandemic could extend through 2023, studies three-dose vaccine course for children

The U.S. pharmaceutical company made its comments as European countries geared up for further travel and social restrictions and a study warned that the rapidly spreading Omicron coronavirus variant was five times more likely to reinfect people than its predecessor, Delta. Pfizer executives said the company believed that by 2024, the disease should be endemic around the globe, meaning it would no longer be a pandemic. The company projected that "COVID will transition to an endemic state potentially by 2024."
19th Dec 2021 - Reuters

CDC recommends Moderna, Pfizer COVID-19 vaccines over J&J's

The U.S. Centers for Disease Control and Prevention on Thursday recommended Americans choose to receive one of two other authorised COVID-19 vaccines over Johnson & Johnson's shot, due to rare but sometimes fatal cases of blood-clotting. The CDC's move came after its Advisory Committee on Immunization voted unanimously to make the recommendation in favour of the vaccines made by Moderna Inc and Pfizer)/BioNTech over the J&J shot.
19th Dec 2021 - Reuters

S.Africa says vaccines, prior infection help mildness of COVID cases

South Africa's health minister said on Friday that the government believed that vaccines and high levels of prior COVID-19 infection were helping to keep disease milder in a wave driven by the Omicron variant. There have been early anecdotal accounts suggesting that Omicron is causing less severe illness than previous variants in South Africa but scientists say it is too early to draw firm conclusions. The country reported a record number of daily infections earlier this week.
19th Dec 2021 - Reuters

The Science Behind Omicron’s Rapid Spread

As Omicron has rapidly taken over as the dominant variant of the coronavirus in South Africa and the U.K., scientists are beginning to piece together what gives it its evolutionary advantage. Researchers are still refining and augmenting their findings, but Omicron’s heightened transmissibility appears to be a combination of several properties: It seems able to more easily bind to and break into human respiratory cells; it appears to replicate faster once within our bodies; and it can substantially evade the immunity gained from past infection or vaccination. These advantages mean Omicron is spreading across the world at a breakneck pace. Since scientists in South Africa first flagged its presence last month, it has been detected in 77 countries and is probably present in most others, according to the World Health Organization.
19th Dec 2021 - The Wall Street Journal

Fauci says omicron variant is `just raging around the world’

The COVID-19 omicron variant is “just raging around the world,” the White House’s top medical adviser said Sunday as President Joe Biden prepares to issue “a stark warning of what the winter will look like” for unvaccinated Americans. Dr. Anthony Fauci, the country’s leading infectious disease expert, told NBC’s “Meet the Press” that “the real problem” for the U.S. hospital system is that “we have so many people in this country who are eligible to be vaccinated who have not yet been vaccinated.” The prospect of a winter chilled by a wave of coronavirus infections is a severe reversal from the optimism projected by Biden some 10 months ago, when he suggested at a CNN town hall that the country would essentially be back to normal by this Christmas. Biden has been careful not to overpromise, yet confidence in the country has been battered by an unrelenting wave of COVID-19 mutations and variations that have left many Americans emotionally exhausted, dispirited and worried about infections.
19th Dec 2021 - The Associated Press

Is UK heading for New Year lockdown? Professor Neil Ferguson: 7,000 Omicron deaths a DAY

Professor Ferguson - the UK Government adviser whose modelling has spooked No10 into lockdowns before - said tighter curbs were needed before New Year to stop a massive hospital surge.
17th Dec 2021 - Daily Mail

Moderna COVID-19 shot likelier to cause heart inflammation than Pfizer's: study

Moderna's COVID-19 vaccine is up to four times more likely to cause inflammation of the heart muscle, a very rare side effect, than its rival vaccine from Pfizer-BioNTech, according to a Danish study published in the British Medical Journal late on Thursday. The study, in which almost 85% of Danes, or 4.9 million individuals, aged 12 and older participated, investigated the link between mRNA-based COVID-19 vaccines and heart inflammation, also known as myocarditis or myopericarditis. Earlier studies from Israel and the United States have indicated an increased risk of heart inflammation after inoculation with the mRNA-vaccines developed by Pfizer-BioNTech and Moderna.
17th Dec 2021 - Reuters

'Tidal wave': Omicron could put U.S. COVID-19 surge into overdrive

Two years into the coronavirus pandemic, the United States is confronting another dark winter, with the red-hot Omicron variant threatening to worsen an already dangerous surge of cases. Hospitalizations for COVID-19 have jumped 45% over the last month, and confirmed cases have increased 40% to a weeklong average of 123,000 new U.S. infections a day, according to a Reuters tally. Pfizer Inc, one of the chief vaccine makers, on Friday predicted the pandemic would last until 2024 and said a lower-dose version of its vaccine for children ages 2 to 4 generated a weaker-than-expected immune response, which could delay authorization
17th Dec 2021 - Reuters

EU to place order with Pfizer for COVID shots adapted to Omicron

European Union governments have agreed to exercise an option to buy more than 180 million doses of a version of the COVID-19 vaccine adapted for the Omicron variant developed by BioNTech and Pfizer, the head of the European Commission said. Pfizer and BioNTech began development of a prototype Omicron-specific vaccine on November 25, and said they could have it ready in March. "The Member States have agreed to trigger a first tranche of over 180 million extra doses of adapted vaccines, in our third contract with BioNTech-Pfizer," Ursula von der Leyen told a news conference on Thursday night at the end of a regular summit with EU leaders.
17th Dec 2021 - Reuters

Moderna Drops Pursuit of U.S. Patent for Key Component of Covid-19 Vaccine

Moderna Inc. has abandoned its application for a U.S. patent covering its Covid-19 vaccine that has been the subject of a heated dispute with the National Institutes of Health over the invention of a key component of the shot. The Cambridge, Mass., company said Friday it dropped the patent application “to allow more time for discussions with the NIH” aimed at an amicable resolution. At issue was credit for a key component of Moderna’s Covid-19 vaccine, among the most widely used in the world. Patent holders could seek a cut of the shot’s billions of dollars in sales, though NIH hasn’t said whether it is interested in royalties.
17th Dec 2021 - The Wall Street Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Dec 2021

View this newsletter in full

EU Strikes Deal With Moderna to Speed German Vaccine Supply

The European Union brokered a deal to expedite deliveries of the Moderna Covid-19 vaccine to countries like Germany that are experiencing temporary shortages as they try to accelerate inoculation and ward off the omicron variant. Moderna Inc. agreed to bring forward delivery of 10 million doses to Germany in December, enough for 20 million boosters, the European Commission said Thursday. The company will also provide 25 million extra shots to Germany in the first quarter of 2022. Germany has started rationing Covid vaccines through the rest of the year as it seeks to maintain momentum in its ramped-up booster campaign going despite an unexpected shortage of BioNTech SE vaccines.
16th Dec 2021 - Bloomberg

Denmark approves treatment with Merck's COVID-19 tablet molnupiravir

Danish health authorities on Thursday approved treatment with Merck & Co Inc’s molnupiravir tablet for COVID-19 patients at risk of serious illness, including the elderly. The medication has yet to be approved by the European Medical Agency, which in late November started reviewing U.S. drugmaker Merck’s experimental COVID-19 antiviral pill for adults and said it could issue an opinion within weeks.
16th Dec 2021 - KFGO News

Pfizer says its COVID pill will protect against severe disease, even from Omicron

Scientists are working to learn more about a new COVID-19 variant, Omicron, that was first detected in South Africa, setting out to discover how transmissible it is, whether the vaccines that are currently available are effective against it, and other answers as much is still unknown about the strain. In order to shore up protection against the virus amid data that show immunity wanes from the vaccines over time, US health officials have expanded their recommendations for who should get COVID-19 booster shots to include people 16 and older. The expansion comes as COVID-19 cases and hospitalizations rise in Massachusetts, in what experts fear is the start of a winter surge.
16th Dec 2021 - MSN

GSK/Sanofi Covid booster delayed by lack of uninfected people to test it on

Efforts by the British and French drugmakers GSK and Sanofi Pasteur to produce a Covid-19 vaccine have suffered a further setback, with final clinical data on the jab and a potential launch delayed until next year as they struggle to find enough uninfected people to test it on. The two vaccine specialists announced positive preliminary results from a trial that showed the vaccine raised antibody levels against Covid by nine to 43 times when given as a single booster shot in people who had already received doses of AstraZeneca, Johnson & Johnson, Moderna or Pfizer/BioNTech vaccines, for all age groups. There were no safety concerns, according to an independent review body. It is the most comprehensive booster trial to date, said GSK and Sanofi.
16th Dec 2021 - The Guardian

Covid 19: US cases rise amid omicron fears but booster shots offer protection, experts say

Some 800 000 Americans have died from covid-19, the highest number of any country in the world, and cases, deaths, hospital admissions, and local transmission are increasing as the threat of omicron is growing, Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), has said. However, two doses of an mRNA vaccine and a booster provide good protection and there is no need for a booster specific for the variant, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and President Joe Biden’s medical advisor. Both spoke at a White House press briefing yesterday on 15 December.1 Jeffrey Zients, the White House coronavirus response coordinator, said, “The US vaccination programme has already prevented 10.3 million hospital admissions. And it has saved 1.1 million American lives.”
16th Dec 2021 - The BMJ

Covid-19 antiviral drug thapsigargin excites researchers in early tests with ‘one of a kind’ results

A researcher at a British university believes he may have found a unique new antiviral drug that can stop the cause of Covid-19, could be made into a pill, tackles respiratory syncytial virus (RSV) and influenza, and crucially would not encourage drug resistance. Prof Kin-Chow Chang of Nottingham University told i that early lab results for the antiviral, thapsigargin, have been so promising in the way it arms the body against the Sars-CoV-2 coronavirus that they almost appear “too good to be true” – showing it is “one of a kind”. Prof Chang emphasises that his team’s research, using cells and mice, is still at a preliminary stage. But further trials on animals are expected next year and his confidence is growing.
16th Dec 2021 - iNews

Takeda submits approval request for Novavax's COVID-19 vaccine in Japan

Takeda Pharmaceutical Co Ltd has submitted an approval request for Novavax's COVID-19 vaccine to Japan's health ministry, the U.S. drugmaker said late on Wednesday.
16th Dec 2021 - Reuters

Japan approves Moderna COVID vaccine as booster, Novavax files for 1st approval

Japan on Thursday officially approved Moderna Inc's COVID-19 vaccine for its booster programme, while Novavax Inc filed for first approval of its shot in the country. Moderna's mRNA-type vaccine, used mostly in Japan to date at workplace inoculation sites, was approved for used as a third booster shot for those aged 18 or older, following a recommendation from health ministry experts on Wednesday.
16th Dec 2021 - Reuters

Omicron thrives in airways, not lungs; new data on asymptomatic cases

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Omicron multiplies faster in airways, slower in lungs Major differences in how efficiently Omicron and other variants of the coronavirus multiply may help predict Omicron's effects, researchers said on Wednesday. Compared to the earlier Delta variant, Omicron multiplies itself 70 times more quickly in tissues that line airway passages, which may facilitate person-to-person spread, they said. But in lung tissues, Omicron replicates 10 times more slowly than the original version of the coronavirus, which might contribute to less-severe illness.
16th Dec 2021 - Reuters

EU regulator okays COVID-19 treatments from GSK-Vir and Sobi

The European Union's drug regulator on Thursday approved a COVID-19 treatment from British-U.S. duo GSK and Vir Biotechnology and another from Swedish drugmaker Sobi, as the bloc builds its defences against Omicron. The approval by the European Medicines Agency (EMA) of GSK-Vir's antibody drug Xevudy and Sobi's arthritis drug Kineret come as governments struggle with soaring infections and worry about the swiftly-spreading Omicron variant of the coronavirus. EMA's human medicines committee recommended using Kineret to treat COVID-19 in adults with pneumonia requiring oxygen support and those at risk of developing severe respiratory failure.
16th Dec 2021 - Reuters

Valneva says its booster works as a follow up to its own COVID-19 shot

French biotech firm Valneva said on Thursday its COVID-19 vaccine candidate was efficient as a booster for people who had received the same shot as an initial vaccination. "Initial results confirm that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination," it said in a statement. The news comes almost two weeks after a British study showed VLA2001 was the only shot out of seven that offered no immunity boost when given to people previously immunised with Pfizer's COVID-19 vaccine
16th Dec 2021 - Reuters

Regeneron says its COVID-19 therapy has lower potency against Omicron

AstraZeneca and Regeneron on Thursday reported contrasting data on the effectiveness of their COVID-19 antibody therapies against the Omicron variant of the coronavirus, underscoring the major challenges ahead for drugmakers. U.S.-based Regeneron said its REGEN-COV therapy, also called Ronapreve, is less effective against Omicron, though it is still active against the Delta variant, confirming indications from lab tests and computer modelling late last month
16th Dec 2021 - Reuters

As COVID cases rise, Spain approves booster shots for over 40s

Spain will administer a third dose of coronavirus vaccine to people aged 40 and over, the Health Ministry said on Thursday, expanding the booster programme a day after its child vaccination campaign kicked off amid a sharp rise in cases. The ministry, which had already rolled out booster shots for the over 60s, health workers and clinically vulnerable, said the most elderly remained the priority, as well as those yet to receive any shot. "Progressively, the booster dose may be administered to persons aged 49 to 40 years, starting with the oldest age cohorts," the ministry said in a statement.
16th Dec 2021 - Reuters

Denmark approves Merck's COVID-19 pill for at-risk patients

Denmark on Thursday approved Merck & Co Inc's molnupiravir antiviral pill for COVID-19 patients at risk of serious illness, including the elderly. The treatment is still under review by the European Medicines Agency (EMA). Faced with rising coronavirus cases, the EU drug regulator issued advice in November on using it for adults ahead of providing any wider recommendation. Announcing its approval for restricted use in Denmark, Health Authority chief medical officer Kirstine Moll Harboe said: "We believe that the benefits of being treated (with it) outweigh the disadvantages for those patients who are most at risk of becoming seriously ill with COVID-19."
16th Dec 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Dec 2021

View this newsletter in full

Sanofi, GSK say COVID-19 vaccine booster candidate give good immune response

Sanofi and GlaxoSmithKline said on Wednesday a single booster dose of their COVID-19 vaccine candidate provided strong immune responses, preliminary data from clinical trials show, a boost for the drugmakers after lagging the vaccine race.
15th Dec 2021 - Reuters

The Hunt for a One-Shot Coronavirus Vaccine

Wang’s lab is one of several racing to develop such a shot. Others include researchers at Duke University, the California Institute of Technology and Walter Reed Army Institute of Research. The research is still in its early days, and scientists have yet to figure out which parts of the virus to target, what technology works best and how broad-acting the shot could be. But in the long term, the biggest question may be not the science but who is going to fund large trials and manufacturing scale-up if the pan-coronavirus results continue to remain promising. Many existing Covid-19 vaccine companies haven’t invested heavily in the pan-coronavirus work, as they wait for the research to mature. Until they decide to invest more significantly, large dollops of government and nonprofit funding will be required to move it forward, and it isn’t yet clear where all the money would come from.
15th Dec 2021 - Bloomberg

Vaccines still provide ‘significant protection’ against severe COVID-19

Omicron has been the latest variant to test the effectiveness of COVID-19 vaccines. COVID-19 vaccines appear to have become less effective in preventing severe COVID-19 disease and death, but they still provide ‘significant protection’, says the World Health Organisation (WHO), according to Reuters. The Omicron variant, first detected in South Africa and Hong Kong last month, has now been reported by 77 countries. WHO director general Tedros Adhanom Ghebreyesus emphasised that it should not be dismissed as “mild”.
15th Dec 2021 - PharmaTimes

U.S. study suggests vaccines may be ineffective against Omicron without booster

All three U.S.-authorized COVID-19 vaccines appear to be significantly less protective against the newly-detected Omicron variant of the coronavirus in laboratory testing, but a booster dose likely restores most of the protection, according to a study released on Tuesday. The study from researchers at Massachusetts General Hospital, Harvard and MIT that has not yet been peer reviewed tested blood from people who received the Moderna, Johnson & Johnson and Pfizer/BioNTech vaccines against a pseudovirus engineered to resemble the Omicron variant.
15th Dec 2021 - Reuters

Hong Kong researchers urge third COVID-19 shot after new Omicron study

Researchers in Hong Kong have urged people to get a third dose of COVID-19 vaccine as soon as possible, after a study showed insufficient antibodies were generated by the Sinovac and BioNTech products to fend off Omicron. Tuesday's release of the results of a study by scientists in the microbiology department of the University of Hong Kong was the first published preliminary data on the impact of Sinovac's vaccine against the Omicron variant of coronavirus. None of the serum of the 25 Coronavac vaccine recipients contained sufficient antibodies to neutralise the new variant, according to the study, accepted for publication in the journal Clinical Infectious Diseases, the researchers said.
15th Dec 2021 - Reuters

EU regulator backs J&J COVID-19 booster dose for adults

The European Union's drug regulator on Wednesday recommended that a booster dose of Johnson & Johnson's COVID-19 shot may be given at least two months after a first dose in people aged 18 years and older, as the bloc battles surging infections. The Omicron coronavirus variant is swiftly spreading across the globe, with many new cases linked to the mutant and the World Health Organization warning that Omicron poses a "very high" risk but data on its severity is limited. The European Medicines Agency (EMA) said its recommendation to allow J&J booster doses follows data which showed the additional shot led to a rise in antibodies against the COVID-causing SARS-CoV-2 coronavirus.
15th Dec 2021 - Reuters

Pfizer set to oust AstraZeneca as top supplier of COVID-19 shots to poor nations

Pfizer and BioNtech are set to displace AstraZeneca as the main suppliers of COVID-19 vaccines to the global COVAX programme at the start of 2022, a shift that shows the increasing importance of their shot for poorer states. The expected change comes with headaches for receiving countries that lack sufficient cold storage capacity to handle the Pfizer vaccine, and amid risks of a shortage of syringes needed to administer that shot. AstraZeneca is currently the most distributed vaccine by COVAX, according to data from Gavi, the vaccine alliance that co-manages the programme with the World Health Organization (WHO).
15th Dec 2021 - Reuters

Sanofi, GSK delay data on COVID-19 vaccine booster candidate until 2022

Sanofi and GlaxoSmithKline said on Wednesday they expect data from late-stage clinical trials of its booster dose of their COVID-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as the French and British partners said preliminary data from trials showed the single-dose booster provided strong immune responses. The companies said they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted COVID-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022."
15th Dec 2021 - Reuters

COVID-19 vaccines may be less effective against Omicron - WHO

Preliminary evidence indicates that COVID-19 vaccines may be less effective against infection and transmission linked to the Omicron coronavirus variant, which also carries a higher risk of reinfection, the World Health Organization said on Wednesday. The WHO, in its weekly epidemiological update, said that more data was needed to better understand the extent to which Omicron may evade immunity derived from either vaccines or previous infection.
15th Dec 2021 - Reuters

Will we always need Covid-19 boosters? Experts have theories

With the world facing the latest in a seemingly endless stream of coronavirus variants — and with bullish talk from manufacturers about a need for even more vaccine shots — you wouldn’t be alone if you were wondering: Are Covid boosters always going to be a fixture in our future? The simple truth is that, at this point, there’s no definitive answer to that question. But virologists, immunologists, and vaccinologists have opinions that are anchored in an understanding of how the immune system works and in emerging data on how Covid vaccines engage with this complicated enterprise that has evolved to help humans fend off disease threats.
15th Dec 2021 - Stat News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Dec 2021

View this newsletter in full

Needle-free Covid-19 vaccine being trialled in the UK

A trial is being launched of a new needle-free Covid-19 vaccine that could give ‘wide-ranging protection’ against variants and future coronaviruses. The University of Southampton has developed the new vaccine which uses a jet of air to push it through the skin rather than a needle. Saul Faust, clinical chief investigator and director of the NIHR Southampton Clinical Research Facility, said: ‘This isn’t simply ‘yet another’ coronavirus vaccine as it has both Covid-19 variants and future coronaviruses in its sights. ‘This technology could give wide-ranging protection to huge numbers of people worldwide.’
14th Dec 2021 - Metro.co.uk

Covid-19 milestones: 800,000 deaths, 50 million infections, 1 year of vaccines

Tuesday marks precisely one year since the first coronavirus vaccine shots were going into arms in the US. Over the course of that year, an incredible 202 million people and counting -- more than 60% of the entire US population -- have been fully vaccinated; about 484 million vaccine doses have been delivered; and now the government is encouraging everyone 16 and older to get a booster shot. The number of people fully vaccinated is both incredible and not nearly enough. Fights over how to get the rest of the country to utilize the shots waiting for them have turned into a massive political and legal standoff over requirements.
14th Dec 2021 - CNN

Malaysia gives conditional approval for use of Ronapreve COVID-19 treatment

Malaysia's health ministry said on Tuesday it has given conditional approval for the use of the single-dose antibody cocktail Ronapreve, developed by Regeneron (REGN.O) and Roche (ROG.S), to treat COVID-19. It has also approved a request from Merck & Co (MRK.N) for a clinical trial import license for its COVID-19 pill Molnupiravir, to be used as part of studies being conducted in Malaysia, the ministry said in a statement.
14th Dec 2021 - Reuters

Russia yet to hand over all data for COVID vaccine's WHO approval - Kremlin

Russia has still not handed over all the information needed for its flagship Sputnik V COVID-19 vaccine to be approved by the World Health Organisation because of differences in regulatory standards, the Kremlin said on Tuesday. Moscow rushed to approve the Sputnik V shot for domestic use last year, but it has still not been certified by either the WHO or the European Medicines Agency, the EU's drug regulator. Asked what was causing the delay, Kremlin spokesman Dmitry Peskov told reporters the certification process was under way.
14th Dec 2021 - Reuters

India stuck with COVID-19 vaccines it can't export

India is struggling to export its surplus of COVID-19 vaccines as logistical hurdles delay their use in many countries despite low levels of inoculation, vaccine producer the Serum Institute of India (SII) and a government official said on Tuesday. The SII, the world's biggest vaccine maker that produces the AstraZeneca, Novavax and Sputnik COVID-19 shots, has already announced plans to temporarily halve output of the AstraZeneca drug until more orders came, including possibly through boosters. read more
14th Dec 2021 - Reuters

Higher risk of heart complications from COVID-19 than vaccines -study

COVID-19 infections are more likely to trigger rare cardiovascular complications such as heart inflammation and irregular heartbeat than vaccines, a British study showed on Tuesday, after scientists parsed data of about 38 million vaccinated people. The study, published in the Nature Medicine journal, compared the risks of myocarditis, pericarditis and cardiac arrhythmia following a first and second dose of COVID-19 vaccines – from AstraZeneca-Oxford, Pfizer-BioNTech, and Moderna - with coronavirus infections.
14th Dec 2021 - Reuters

Pfizer says COVID-19 pill near 90% effective in final analysis

Pfizer Inc on Tuesday said its antiviral COVID-19 pill showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron variant of the coronavirus. The U.S. drugmaker last month said the oral medicine was around 89% effective in preventing hospitalizations or deaths when compared to placebo, based on interim results in around 1,200 people. Data from its final analysis of the trial disclosed on Tuesday includes an additional 1,000 people. Nobody in the trial who received the Pfizer treatment died, compared with 12 deaths among placebo recipients.
14th Dec 2021 - Reuters

Moderna to produce millions of mRNA vaccines in Australia

U.S. drugmaker Moderna Inc will produce millions of mRNA vaccines a year in Australia after agreeing to set up one of its largest manufacturing facilities outside the United States and Europe. The deal, a second such commitment in Asia Pacific by a western mRNA vaccine developer, underscores efforts by governments around the world to build up local production and prepare for future pandemic threats after limited early access to shots led to slow COVID-19 vaccine rollouts.
14th Dec 2021 - Reuters

Pfizer Covid Pill Effective to Stop Hospitalization, New Study Shows

New study data showed Pfizer Inc.’s experimental Covid-19 pill was highly effective at keeping patients out of the hospital, but less adept at erasing milder symptoms often associated with breakthrough infections. Pfizer disclosed findings from two studies in a statement Tuesday. In one, its treatment, Paxlovid, failed to meet the primary goal of reducing self-reported symptoms in 673 adults at standard risk of developing Covid-19 complications. The drug showed a trend toward reducing hospitalizations in the group by 70%, however. In the other study, the treatment remained 89% effective in preventing hospitalizations in high-risk unvaccinated people when used within 3 days of the appearance of symptoms. That confirmed Pfizer’s earlier analysis of results from a smaller number of patients.
14th Dec 2021 - Bloomberg

Data indicate omicron is milder, better at evading vaccines

The omicron variant is offering more hints about what it may have in store as it spreads around the globe: A highly transmissible virus that may cause less severe disease, and one that can be slowed — but not stopped — by today’s vaccines. An analysis Tuesday of data from South Africa, where the new variant is driving a surge in infections, suggests the Pfizer vaccine offers less defense against infection from omicron and reduced, but still good, protection from hospitalization. The findings are preliminary and have not been peer-reviewed — the gold standard in scientific research — but they line up with other early data about omicron’s behavior, including that it seems to be more easily spread from person to person.
14th Dec 2021 - The Associated Press

New Australian plant could make 100 million vaccines a year

Australia’s government said Tuesday it plans to start making mRNA vaccines at home with a new plant that could produce up to 100 million doses each year. The announcement came as coronavirus cases in Sydney and surrounding areas jumped, driven in part by the omicron variant. The new factory would be built in Victoria state in a partnership between vaccine manufacturer Moderna and the federal and state governments. It is expected to open by 2024. Australian Prime Minister Scott Morrison said it was in the country’s national interest to produce vaccines locally.
14th Dec 2021 - The Associated Press

Pfizer jab protects against hospitalisation with Omicron: Study

Two doses of Pfizer-BioNTech’s COVID-19 vaccine appear to provide 70 percent protection against hospitalisation from the Omicron coronavirus variant, according to an extensive real-world study in South Africa. The analysis released on Tuesday by South Africa’s largest private health insurance administrator, Discovery Health, was based on more than 211,000 positive COVID-19 test results of adults from November 15 to December 7, about 78,000 of which were attributed to Omicron.
14th Dec 2021 - AlJazeera

Leading Covid-19 experts on the questions they want answered about Omicron

For some Covid experts, what’s most unsettling about the Omicron variant is all the uncertainty surrounding it. That’s what keeps John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, up at night. “I’ve lost more sleep worrying about answering questions about Omicron than over Omicron itself,” he said during a panel at STAT’s “A Look Ahead at Biotech 2022”event last week. Moore, like many other experts, is waiting for more data before judging how the new variant is going to pan out. More time will tell us whether Omicron will fizzle out and be forgettable like Beta, or if it will be much more consequential and replace Delta, in much the same way Delta replaced Alpha.
14th Dec 2021 - STAT News

Pfizer shot less effective in South Africa after Omicron emerges, study shows

Pfizer-BioNTech's COVID-19 vaccine has been less effective in South Africa at keeping people infected with the virus out of hospital since the Omicron variant emerged last month, a real-world study published on Tuesday showed. Between Nov. 15 and Dec. 7, people who had received two doses of the shot had a 70% chance of avoiding hospitalisation, down from 93% during the previous wave of Delta infections, the study showed.
14th Dec 2021 - Reuters

One year of vaccines: Many lives saved, many needlessly lost

One year ago, the biggest vaccination drive in American history began with a flush of excitement in an otherwise gloomy December. Trucks loaded with freezer-packed vials of a COVID-19 vaccine that had proved wildly successful in clinical trials fanned out across the land, bringing shots that many hoped would spell the end of the crisis. That hasn’t happened. A year later, too many Americans remain unvaccinated and too many are dying. The nation’s COVID-19 death toll stands at around 800,000 as the anniversary of the U.S. vaccine rollout arrives. A year ago it stood at 300,000.
13th Dec 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Dec 2021

View this newsletter in full

Two-Dose Covid Vaccine Less Effective Against Omicron Than Delta, Study Shows

The omicron variant dented the protection afforded by two doses of Pfizer Inc.’s and AstraZeneca Plc’s Covid vaccines as feared, researchers found, increasing the risk of infection. Blood samples collected from people vaccinated with the two different shots and tested against the new strain showed a substantial drop in neutralizing antibodies, a proxy for protection, particularly compared with the delta variant, researchers from the University of Oxford said Monday in a paper.
14th Dec 2021 - Bloomberg

Moderna amends Covid-19 vaccine supply deal with Gavi

Moderna has amended an existing contract with Gavi, the Vaccine Alliance, to expedite the supply of 20 million doses of its Covid-19 vaccine to COVAX by the end of this year. Under the deal, the company agreed to deliver a total of 54 million vaccine doses to COVAX this year. The supply of the vaccine doses to COVAX Advance Market Commitment (AMC) nations has already been initiated. They were initially agreed to be delivered in the first quarter of next year as part of the company’s prior agreement with Gavi.
13th Dec 2021 - Pharmaceutical Technology

Vaccine committee rules against fourth COVID shot

Individuals double vaccinated against COVID-19 within the last six months can't receive a booster and still need to wait to get their third jab, the Pandemic Response Team and the Advisory Committee on Vaccines said late Sunday night. The committee met for several hours to discuss the issue, as 67 cases of Omicron were discovered in Israel and dozens more are under investigation.
13th Dec 2021 - The Jerusalem Post

China's Brii says its COVID-19 antibody cocktail retains activity against Omicron

China's Brii Biosciences said on Sunday lab studies showed that its COVID-19 antibody cocktail retained activity against the Omicron variant, although one of the antibodies showed a substantial drop in activity when tested alone. Test details for the dual-antibody treatment, which last week became the first approved COVID-19 antibody cocktail in China, would not be available until publication in a scientific journal, but results from three independent labs showed similar pattern, Brii chief executive Hong Zhi said on Monday
13th Dec 2021 - Reuters

Israeli study finds Pfizer COVID-19 booster protects against Omicron

Israeli researchers said on Saturday they found that a three-shot course of the Pfizer/BioNTech, COVID-19 vaccine provided significant protection against the new Omicron variant. The findings were similar to those presented by BioNTech and Pfizer earlier in the week, which were an early signal that booster shots could be key to protect against infection from the newly identified variant. The study, carried out by Sheba Medical Center and the Health Ministry's Central Virology Laboratory, compared the blood of 20 people who had received two vaccine doses 5-6 months earlier to the same number of individuals who had received a booster a month before.
13th Dec 2021 - Reuters

Omicron poses 'very high' risk but data on severity limited

The Omicron coronavirus variant, reported in more than 60 countries, poses a "very high" global risk, with some evidence that it evades vaccine protection but clinical data on its severity is limited, the World Health Organization says. Considerable uncertainties surround Omicron, first detected last month in southern Africa and Hong Kong, whose mutations may lead to higher transmissibility and more cases of COVID-19 disease, the WHO said in a technical brief issued on Sunday. "The overall risk related to the new variant of concern Omicron remains very high for a number of reasons," it said, reiterating its first assessment of Nov. 29.
13th Dec 2021 - Reuters

Antibody response from China Zhifei's COVID shot weaker against Omicron

China's Anhui Zhifei Longcom Biopharmaceutical said on Monday a small laboratory test showed its COVID-19 vaccine could trigger antibodies against the Omicron variant though the response was weaker than against an older variant of the virus. The unit of Chongqing Zhifei Biological Products is the first Chinese vaccine developer to announce early data on how its COVID-19 vaccine work against Omicron, which has triggered global alarm about another surge in infections.
13th Dec 2021 - Reuters

Omicron spreads faster and weakens jabs: WHO

The omicron coronavirus variant is more transmissible than the delta strain and reduces vaccine efficacy but causes less severe symptoms according to early data, the World Health Organization said Sunday. The delta variant, first identified in India earlier this year, is responsible for most of the world’s coronavirus infections. But South Africa’s discovery of omicron — which has a large number of mutations — last month prompted countries around the world to impose travel bans on southern African countries and reintroduce domestic restrictions to slow its spread.
13th Dec 2021 - Arab News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Dec 2021

View this newsletter in full

How Sequencing Covid-19’s Viral Genome Helps Hunt for Variants

To keep up with changes to the virus that causes Covid-19, scientists are using a technology called genomic sequencing. The process starts with a Covid-19 test. Some samples that test positive for the coronavirus in a laboratory are pulled aside and sent off for sequencing, a review of the virus’s genetic material that can take as little as a day or more than a week. The SARS-CoV-2 genome has about 30,000 individual building blocks to decode, compared with about three billion in the human genome. Sometimes researchers have equipment to sequence the samples on hand or nearby. But often samples must be shipped elsewhere, which can take days. “Just the sheer logistics of shipping these samples from where they’re tested to where they’re going to be sequenced, that can be huge,” said Pavitra Roychoudhury, an acting instructor in the laboratory medicine and pathology department at the University of Washington.
12th Dec 2021 - The Wall Street Journal

Taiwan confirms first cases of Omicron variant

Taiwan confirmed on Saturday its first cases of the Omicron variant of coronavirus, found in three people who had arrived from abroad. The island's Central Epidemic Command Centre said the infections were found in travellers arriving from Britain, the southern African nation of Eswatini and the United States. Like all entrants, they were tested on arrival and already subject to two weeks of quarantine.
11th Dec 2021 - Reuters

COVID-19: Two jabs offer little protection against Omicron - but booster makes vaccine at least 70% effective

Two doses of the AstraZeneca and Pfizer/BioNtech vaccines offer little protection against the Omicron variant of COVID, but a booster raises their effectiveness to between 70 and 75 percent. The UK Health Security Agency also said the country will have more than one million Omicron infections by the end of this month if current trends continue unchanged. Analysis of 581 people with confirmed Omicron showed the AstraZeneca and Pfizer/BioNtech jabs provided "much lower levels of protection against symptomatic infection compared to the protection that they provide against Delta", it said in a statement. But it added: "The preliminary data showed effectiveness against the new variant appears to increase considerably in the early period after a booster dose, providing around 70-75% protection against symptomatic infection.
11th Dec 2021 - Sky News

South Africa says no signal of increased Omicron severity yet

South African scientists see no sign that the Omicron coronavirus variant is causing more severe illness, they said on Friday, as officials announced plans to roll out vaccine boosters with daily infections approaching an all-time high. South Africa alerted the world to Omicron late last month, prompting alarm that the highly mutated variant could trigger a new surge in global infections. Hospital data show that COVID-19 admissions are now rising sharply in more than half of the country's nine provinces, but deaths are not rising as dramatically and indicators such as the median length of hospital stay are reassuring.
11th Dec 2021 - Reuters

Japan researchers use ostrich cells to make glowing COVID-19 detection masks

Japanese researchers have developed masks that use ostrich antibodies to detect COVID-19 by glowing under ultraviolet light. The discovery by Yasuhiro Tsukamoto and his team at Kyoto Prefectural University in western Japan could provide for low-cost testing of the virus at home, they said in a press release. The scientists started by creating a mask filter coated with ostrich antibodies targeting the novel coronavirus, based on previous research showing the birds have strong resistance to disease.
11th Dec 2021 - Reuters

South African doctors see signs omicron is milder than delta

As the omicron variant sweeps through South Africa, Dr. Unben Pillay is seeing dozens of sick patients a day. Yet he hasn’t had to send anyone to the hospital. That’s one of the reasons why he, along with other doctors and medical experts, suspect that the omicron version really is causing milder COVID-19 than delta, even if it seems to be spreading faster. “They are able to manage the disease at home,” Pillay said of his patients. “Most have recovered within the 10 to 14-day isolation period.” said Pillay. And that includes older patients and those with health problems that can make them more vulnerable to becoming severely ill from a coronavirus infection, he said.
11th Dec 2021 - The Associated Press

Omicron Now Dominant Variant in Cape Town, Wastewater Shows

Omicron is now the dominant coronavirus variant in Cape Town, the South African Medical Research Council said, citing wastewater analyses. The variant was found in 11 of 12 wastewater samples collected in Cape Town on Nov. 30, the council said in a statement on Friday. The delta variant was only dominant at one wastewater plant in the city, it said. People infected with Covid-19 shed viral particles in their feces. While the particles are not infectious, they provide an indication of the prevalence of the disease and can be used to determine which variant is dominant
10th Dec 2021 - Bloomberg

Omicron Will Be Dominant Strain Within Days, Say U.K. Officials

Covid vaccine boosters improve protection to as much as 75% against a rapidly spreading omicron variant that’s much more likely to bypass two doses than earlier strains, preliminary U.K. data show. The basic course of shots from AstraZeneca Plc and the Pfizer Inc.-BioNTech SE partnership provided much lower defenses against symptomatic infection with omicron, compared with the delta strain, the initial study showed. A booster lifted protection to 70% to 75% in the early days after the shot. “These early estimates should be treated with caution, but they indicate that a few months after the second jab, there is a greater risk of catching the omicron variant,” Mary Ramsay, head of immunization at the U.K. Health Security Agency, said in a statement.
10th Dec 2021 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Dec 2021

View this newsletter in full

FDA expands Pfizer COVID booster, opens extra dose to age 16

The U.S. is expanding COVID-19 boosters, ruling that 16- and 17-year-olds can get a third dose of Pfizer’s vaccine. The U.S. and many other nations already were urging adults to get booster shots to pump up immunity that can wane months after vaccination, calls that intensified with the discovery of the worrisome new omicron variant. On Thursday, the Food and Drug Administration gave emergency authorization for 16- and 17-year-olds to get a third dose of the vaccine made by Pfizer and its partner BioNTech -- if it’s been six months since their last shot.
9th Dec 2021 - Associated Press on MSN.com

Could a One-Shot Coronavirus Vaccine Protect You From All Variants?

As Covid-19 began spreading in early 2020, one of Linfa Wang’s first ideas was to test the blood of people who’d survived a previous coronavirus outbreak. The virologist, who works out of Duke-NUS Medical School, a collaboration between Duke and the National University of Singapore, has been studying bat-borne viruses for decades. He’d helped show that SARS-CoV-1, which killed almost 800 people in 2003, likely jumped to humans from horseshoe bats. Wang’s new theory was that people who’d recovered from the original SARS might harbor antibodies that could help fight the new one, SARS-CoV-2.
9th Dec 2021 - Bloomberg

COVID-19: Omicron variant may be 'milder' but its infection rate could be 'devastating', expert warns

The new Omicron variant of coronavirus appears to be causing "milder" cold-like symptoms, but its reported rapid infection rate "even in the vaccinated" could still have "devastating" consequences, a top scientist has warned. Early data has suggested the new variant could result in less severe disease than previous waves. However, Tim Spector, lead scientist on the Zoe COVID Study, warned against complacency, saying, "this is not a reason to be relaxed about Omicron".
9th Dec 2021 - Sky News

Doctors weigh COVID-19 impact on children as vaccine drives ramp up

One month after her son Eran had recovered from a mild case of COVID-19, Sara Bittan rushed the three-year-old to the emergency room. He had high fever, a rash, his eyes and lower body were swollen and red, his stomach was hurting and he was crying in pain. Eventually diagnosed with the rare multisystem inflammatory syndrome in children (MIS-C), also known as pediatric inflammatory multisystem syndrome, or PIMS, Eran was hospitalized in October for a week and has fully recovered, Bittan said.
9th Dec 2021 - Reuters

Britain starts recruiting for real-world COVID antiviral trial

British researchers on Wednesday started recruitment for a clinical trial to test antiviral COVID-19 treatments for use in people early on in the disease who are at higher risks of complications, starting with Merck's molnupiravir. Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November. Britain's Medicines and Healthcare products Regulatory Agency (MHRA) recommended the antiviral pill for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease.
9th Dec 2021 - Reuters

U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail

The U.S. Food and Drug Administration on Wednesday authorized the use of AstraZeneca's antibody cocktail to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines. The antibody cocktail, Evusheld, is only authorized for adults and adolescents who are not currently infected with the novel coronavirus and have not recently been exposed to an infected individual, the regulator said. The authorization for the therapy, made up of two monoclonal antibodies tixagevimab and cilgavimab, marks a significant step for AstraZeneca, whose widely used COVID-19 vaccine is yet to be approved by U.S. authorities.
9th Dec 2021 - Reuters

China approves Brii Biosciences antibody COVID treatment

China's medical products regulator said on Wednesday it had approved the use of Brii Biosciences' neutralising antibody cocktail for COVID-19, the first treatment of its type against the virus given the go-ahead in the country. The combination of BRII-196/BRII-198 showed a 80% reduction of hospitalisation and deaths in non-hospitalised COVID-19 patients at high risk of developing severe disease, based on final results from a Phase III clinical trial, Brii said in a statement on Thursday.
9th Dec 2021 - Reuters

Vaccine makers racing to update COVID shots, just in case

Vaccine makers are racing to update their COVID-19 shots against the newest coronavirus threat even before it’s clear a change is needed, just in case. Experts doubt today’s shots will become useless but say it’s critical to see how fast companies could produce a reformulated dose and prove it works -- because whatever happens with omicron, this newest mutant won’t be the last. Omicron “is pulling the fire alarm. Whether it turns out to be a false alarm, it would be really good to know if we can actually do this -- get a new vaccine rolled out and be ready,” said immunologist E. John Wherry of the University of Pennsylvania.
9th Dec 2021 - The Associated Press

The AP Interview: CDC chief says omicron mostly mild so far

More than 40 people in the U.S. have been found to be infected with the omicron variant so far, and more than three-quarters of them had been vaccinated, the chief of the CDC said Wednesday. But she said nearly all of them were only mildly ill. In an interview with The Associated Press, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said the data is very limited and the agency is working on a more detailed analysis of what the new mutant form of the coronavirus might hold for the U.S. “What we generally know is the more mutations a variant has, the higher level you need your immunity to be. ... We want to make sure we bolster everybody’s immunity. And that’s really what motivated the decision to expand our guidance,” Walensky said, referencing the recent approval of boosters for all adults.
9th Dec 2021 - The Associated Press

FDA expands authorization for Pfizer’s Covid-19 booster to cover 16- and 17-year-olds

The Food and Drug Administration on Thursday expanded the emergency use authorization for Pfizer and BioNTech’s Covid-19 booster shot to cover 16- and 17-year-olds, making it the only booster shot currently available in the United States for teenagers in this age group. Within hours, Rochelle Walensky, director of the Centers for Disease Control and Prevention, signed off on the expanded authorization, clearing the way for 16- and 17-year olds to book booster shot appointments. “Today, CDC is strengthening its booster recommendations and encouraging everyone 16 and older to receive a booster shot,” Walensky said in a statement. “We know that Covid-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least 6 months post their initial Pfizer vaccination series.”
9th Dec 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Dec 2021

View this newsletter in full

Pfizer, BioNTech vaccine neutralises Omicron with three shots

Neutralising antibodies seen one month after third dose. Pfizer CEO says seeking booster shot is the best option. Vaccine may still protect against severe disease Any vaccine relaunch could be achieved in March 2022.
8th Dec 2021 - Reuters

Moderna COVID-19 vaccine approved for booster shots in Australia

The Moderna COVID-19 vaccine has been approved for use in booster shots for adults in Australia. Australia's medicines authority, the Therapeutic Goods Administration (TGA), has given the green light to the shot being used as a booster for people aged 18 and over. Until now, only the Pfizer COVID-19 vaccine has been available for booster shots in Australia. As is advised with the Pfizer booster shot, the Moderna booster shot should be given six months after the second dose of any COVID-19 vaccine. The TGA has also said immunocompromised people aged 12 and over can have a third shot as soon as 28 days after their second vaccine. The TGA said its decision to allow the Moderna vaccine to be used for booster shots was guided by expert advice from the independent Advisory Committee on Vaccines.
8th Dec 2021 - 9News

China approves Brii Biosciences' COVID-19 treatment

China's medical products regulator said on Wednesday it had approved the use of Brii Biosciences' neutralising antibody cocktail for COVID-19, the first treatment of its type against the virus given the go-ahead in the country. The combination of BRII-196/BRII-198 showed a 78% reduction of hospitalization and death in non-hospitalized COVID-19 patients at high risk of developing severe disease in a Phase III clinical trial, Brii said in October. The medicine from a Brii subsidiary was approved to treat mild COVID-19 and the disease of "normal type" with high risk of progressing to hospitalization or death in adults and minors aged 12-17, the National Medical Products Administration said.
8th Dec 2021 - Reuters

EU expects Europe plants to produce 3.6 billion COVID shots in 2022

Vaccine plants in the European Union are expected to produce 3.6 billion COVID-19 shots next year, out of a global output of more than 20 billion, two senior EU officials said on Wednesday. EU countries are administering boosters after having completed the primary vaccination of nearly 70% of the EU population, whereas in Africa only 7% have been immunised against the coronavirus, EU data show.
8th Dec 2021 - Reuters

'I'm so happy': first person to get fully-tested COVID-19 shot says one year on

The first person in the world to be given a fully-tested COVID-19 vaccine, 91-year-old Briton Margaret Keenan, urged people on Wednesday to get vaccinated, one year on from her shot. Keenan described receiving the Pfizer-BioNTech COVID-19 vaccine on Dec. 8 2020 as the "best thing that has ever happened". "It was wonderful. I cannot believe it now, what happened at the time... I'm so happy I got the jab," Keenan, known to friends as Maggie, said in a broadcast clip to mark the anniversary.
8th Dec 2021 - Reuters

Pfizer says COVID booster offers protection against omicron

Pfizer said Wednesday that a booster of its COVID-19 vaccine may offer important protection against the new omicron variant even though the initial two doses appear significantly less effective. Pfizer and its partner BioNTech said that while two doses may not be strong enough to prevent infection, lab tests showed a booster increased by 25-fold people’s levels of antibodies capable of fighting off omicron. For people who haven’t yet had a booster, the companies said two doses still should prevent severe disease or death. Health authorities in the U.S. and other countries have urged eligible people to get a third dose even before these results.
8th Dec 2021 - The Associated Press

Pfizer, BioNTech say omicron partially evades its COVID vaccine but booster can restore protection

The COVID-19 vaccine produced by Pfizer and BioNTech, Comirnaty, provides less protection against the omicron variant than it did against wild-type COVID and other variants, the companies said on Wednesday. They also reported that a third (booster) shot is needed to gain protection against omicron comparable to that provided by the two-dose series against wild-type COVID-19 and other variants. The announcement from the companies came hours after the release of a study by scientists in South Africa that showed the omicron variant could largely evade the antibodies generated by the Pfizer-BioNTech vaccine. The lab study also indicated that booster shots would help restore some level of protection and that the original two-dose series was still likely to prevent a severe form of the disease.
8th Dec 2021 - FiercePharma

Pfizer, ex-employee reach a deal in COVID-19 vaccine trade secrets case

A now-former Pfizer employee is playing nice after the drugmaker sued her in November alleging the 15-year veteran uploaded more than 12,000 sensitive files—including documents on the company's wildly successful COVID-19 vaccine—to personal devices and a Google Drive account. The defendant, Chun Xiao Li, agreed to let Pfizer's lawyers search her personal emails, Google drive accounts and all other personal computing devices or accounts that could contain confidential information or trade secrets by Dec. 6, court documents filed Monday show. Pfizer aims to complete its search by Dec. 29, at which point it will return Li's devices and accounts. By that same day, Li must send Pfizer a sworn declaration that she's cooperated with the investigation to the best of her ability and that she no longer possesses any proprietary information or trade secrets.
8th Dec 2021 - FiercePharma

Pfizer’s vaccine chief on Omicron, mix-and-match boosters, and being prepared for the unknown

Pfizer and partner BioNTech announced Wednesday that new data show that antibodies generated by their Covid vaccine appear less effective against the Omicron variant than other variants, but that a third booster dose likely provides sufficient antibody protection. Those data are very preliminary. But STAT took the opportunity to catch up with Pfizer’s head of vaccine research, Kathrin Jansen, who has been one of the main architects of the development program that has helped make the Pfizer-BioNTech vaccine the most widely used of the Covid shots. Jansen emphasized that Pfizer is developing an Omicron-specific vaccine, but that she does not know exactly what strategy the world should or will take over the coming months. Instead, she is focused on being prepared for anything.
8th Dec 2021 - STAT News

Pfizer-BioNTech Covid-19 shot loses power against Omicron variant, but booster restores protection

People who have received two doses of the Pfizer-BioNTech Covid-19 vaccine are likely susceptible to infection from the Omicron variant of the coronavirus, but a third shot restores antibody activity against the virus, the companies said Wednesday. Their findings are based on lab experiments using the blood of people who have received the vaccine. In a press release, the companies reported a 25-fold reduction on average in the levels of neutralizing antibody activity against the Omicron variant in people who had received two doses of their Covid-19 vaccine. But they also found that blood, or sera, from people who had received boosters “neutralized the Omicron variant to levels that are comparable to those observed” for the original form of the coronavirus that the vaccine was based on, with neutralizing antibody levels increased 25-fold by a third shot.
8th Dec 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Dec 2021

View this newsletter in full

Study suggests Pfizer COVID-19 vaccine only partially protects against Omicron

The Omicron variant of the coronavirus can partially evade the protection from Pfizer Inc (PFE.N) and partner BioNTech's COVID-19 vaccine, the research head of a laboratory at Africa Health Research Institute in South Africa said on Tuesday. Alex Sigal, a professor at the Africa Health Research Institute, said on Twitter there was "a very large drop" in neutralization of the Omicron variant relative to an earlier strain of COVID. The lab tested blood from 12 people who had been vaccinated with the Pfizer/BioNTech vaccine, according to a manuscript posted on the website for his lab. The preliminary data in the manuscript has not yet been peer reviewed.
7th Dec 2021 - Reuters

Scientists find ‘stealth’ version of Omicron that may be harder to track

Scientists say they have identified a “stealth” version of Omicron which cannot be distinguished from other variants using the PCR tests that public health officials deploy to gain a quick picture of its spread around the world. It came as the number of cases of the original Omicron variant detected in the UK rose by 101 to 437 in a single day and Scotland announced a return to working from home. The stealth variant has many mutations in common with standard Omicron, but it lacks a particular genetic change that allows lab-based PCR tests to be used as a rough and ready means of flagging up probable cases. The variant is still detected as coronavirus by all the usual tests, and can be identified as the Omicron variant through genomic testing, but likely cases are not flagged up by routine PCR tests that give quicker results.
7th Dec 2021 - The Guardian

Impact of obesity and metabolic disorders on severity of COVID-19 and vaccine-breakthrough infections

Obesity and impaired metabolic health are important risk factors for severe COVID-19. Novel data indicate that these risk factors might also promote vaccine-breakthrough SARS-CoV-2 infections in fully vaccinated people. In a Nature Reviews Endocrinology “Year in Review” article DZD-Researcher Norbert Stefan summarizes the most important and up-to-date findings about the relationships of obesity, diabetes and cardiovascular diseases with the severity of COVID-19 and SARS-CoV-2 vaccine-breakthrough infections.
7th Dec 2021 - EurekAlert!

Cuba's COVID vaccines: the limited data available suggests they're highly effective

Cuba has been quietly working on its own vaccines, immunising its population and selling doses abroad. Cuba’s vaccine efforts have maintained a relatively low profile in the west to date. Politics may well be a reason. The US embargo against Cuba that began in the cold war is still in effect, and tensions between the countries remain high. But for those familiar with Cuba, its COVID vaccine development should come as no surprise – the country has a long history of manufacturing its own vaccines and medicines. Nor should it be surprising that two of its COVID vaccines – Abdala and Soberana 02 – appear to have performed very well in trials. Here’s how they work...
7th Dec 2021 - The Conversation Africa

Medicago and GSK announce CoVLP, a plant-based coronavirus vaccine

Pharmaceutical companies Medicago and GlaxoSmithKline announced on Tuesday “positive efficacy and safety results” from a global trial using what they say is the world’s first plant-based coronavirus vaccine.
7th Dec 2021 - The Washington Post

The explosion of Covid PTSD cases is a mental health crisis in the making

When the Covid-19 pandemic began, people working in the trauma field knew the psychological toll would be colossal. In the spring of 2020, I began interviewing professionals about the mental health fallout of the pandemic, specifically its impact on frontline medical staff. During the first wave, two in every five intensive care staff in England reported symptoms of post-traumatic stress disorder. That work continued for almost a year, during which time a second wave hit and the initial traumas were exacerbated. But it wasn’t only frontline workers who were experiencing trauma symptoms: Covid has posed perhaps the biggest threat to mental health in England since the second world war. Now, at the tail end of 2021, the pandemic is still not over. The NHS forecasts that nationally, there will be 230,000 new cases of PTSD as a result of Covid-19.
7th Dec 2021 - The Guardian

Growing use of home Covid-19 tests leaves health agencies in the dark about unreported cases

When fans of the band Phish started falling ill with Covid-19 all over the country after a Halloween concert weekend in Las Vegas, public health officials were largely in the dark about what appears to have been a superspreader event. In a Facebook post from mid-November with hundreds of responses, concertgoers compared symptoms and positive test results, many of those from tests taken at home. But those data weren’t added to state public health tallies of Covid’s spread. It’s a story that’s becoming commonplace in the era of rapid home Covid testing: People who test positive are almost never counted by public health agencies charged with bringing the pandemic to heel. While home tests have distinct advantages — they’re convenient and quickly inform people of their infection status so they can take steps to avoid spread the virus — most who test positive don’t come to the attention of health officials unless they are sick enough to see a doctor.
7th Dec 2021 - STAT News

Canadian drugmaker says its COVID-19 vaccine is effective

A Canadian drugmaker said its plant-based COVID-19 vaccine showed strong protection against the virus and will soon seek authorization at home and elsewhere. Medicago announced Tuesday that its two-dose vaccine was 71% effective at preventing COVID-19 infection in a large, late-stage study that included several variants including the delta variant. The company’s results did not include the emerging omicron variant, which wasn’t circulating during the study period. The Quebec City company said it will seek Canadian approval “imminently” and has also begun the process to file with regulators in the U.S., U.K. and other countries. The company said it's also preparing to send its data to the World Health Organization.
7th Dec 2021 - The Independent

COVID-19: Early indications Omicron is more transmissible than Delta variant, Boris Johnson says

The early indications are that the Omicron variant of coronavirus is more transmissible than Delta, the prime minister has said. Boris Johnson made the comment as he updated his team of ministers on the latest COVID-19 situation at a cabinet meeting on Tuesday morning. Downing Street said it is still unclear how severe the disease caused by Omicron is and what impact the vaccines have on the variant.
7th Dec 2021 - Sky News

COVID-19: Previous infection and vaccination combine for best protection against variants

People who have overcome a coronavirus infection and also received a vaccine have higher-quality antibodies against variants, researchers have found. The new study comes amid concerns that new variants of the SARS-CoV-2 virus, such as Omicron, can still infect people who have received two vaccine doses. According to researchers at the American Society for Microbiology, the study could help identify the optimal mix of antibodies to "help guide future preventive efforts".
7th Dec 2021 - Sky News

UK study shows mixing Pfizer and AstraZeneca COVID-19 vaccines with Moderna elicits better immune response

Results show support in favour of heterologous dosing which may help to advance vaccination programmes in poorer countries. A British study mixing COVID-19 vaccines has found that people had a better immune response when they received their first dose of AstraZeneca or Pfizer-BioNTech shots, followed by Moderna nine weeks later, according to Reuters. These results support mix-and-match dosing, otherwise known as heterologous dosing. This is expected to boost vaccine drives in poor and middle income countries, which may need to combine different brands between first and second shots if supplies are running low. Matthew Snape, the Oxford professor behind the study dubbed Com-COV2, said: “We found a really good immune response across the board…, in fact, higher than the threshold set by Oxford-AstraZeneca vaccine two doses
7th Dec 2021 - PharmaTimes

Merck ties up with Thermo Fisher to make its COVID-19 pill in Canada

Drugmaker Merck & Co on Monday announced a deal with Thermo Fisher Scientific to manufacture its experimental COVID-19 pill at the medical device maker's site in Whitby, Ontario. The site will manufacture the pill, molnupiravir, for distribution in Canada and the United Kingdom as well as markets in the European Union, Asia Pacific and Latin America. The Ontario site is one of three manufacturing sites in the world for the pill, which is being developed with Ridgeback Biotherapeutics.
7th Dec 2021 - Reuters

EU regulator backs Roche's arthritis drug for treating severe COVID-19

The European Union's drug regulator on Monday recommended extending the use of Roche's RoActemra arthritis drug for adult COVID-19 patients on systemic treatment with steroids and those who need oxygen support or mechanical ventilation. The European Medicines Agency (EMA) said its human medicines committee evaluated data from a main study involving over 4,000 hospitalised adults, and concluded that the medicine's benefits outweigh the risks for these patients. The EMA's endorsement comes after Europe crossed at least 75 million coronavirus cases as the world braces for the new Omicron variant. Formal approval is up to the European Commission, which typically follows EMA recommendations.
7th Dec 2021 - Reuters

New data shows GSK-Vir drug works against all Omicron mutations

British drugmaker GSK said on Tuesday its antibody-based COVID-19 therapy with U.S. partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies The data, yet to be published in a peer-reviewed medical journal, shows that the companies' treatment, sotrovimab, is effective against all 37 identified mutations to date in the spike protein, GSK said in a statement.
7th Dec 2021 - Reuters

Novavax COVID-19 vaccine could be approved very soon, says EMA chief

The head of the European Medicines Agency (EMA) on Tuesday said that it could soon approve the COVID-19 vaccine developed by U.S. biotech company Novavax (NVAX.O). "The vaccine from Novavax could be authorised in the very near future," Emma Cooke told EU health ministers during a public session of a meeting in Brussels.
7th Dec 2021 - Reuters

EU agencies endorse mix-and-match of COVID-19 vaccines

EU health agencieshave recommended that COVID-19 vaccines be mixed and matched for both initial courses and booster doses as the region battles rising cases ahead of Christmas. Evidence suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the coronavirus causing COVID-19, the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) said in a joint statementon Tuesday.
7th Dec 2021 - Reuters

Omicron v. delta: Battle of coronavirus mutants is critical

As the omicron coronavirus variant spreads in southern Africa and pops up in countries all around the world, scientists are anxiously watching a battle play out that could determine the future of the pandemic. Can the latest competitor to the world-dominating delta overthrow it? Some scientists, poring over data from South Africa and the United Kingdom, suggest omicron could emerge the victor. “It’s still early days, but increasingly, data is starting to trickle in, suggesting that omicron is likely to outcompete delta in many, if not all, places,” said Dr. Jacob Lemieux, who monitors variants for a research collaboration led by Harvard Medical School.
7th Dec 2021 - The Associate Press

New data shows GSK-Vir drug works against all Omicron mutations

British drugmaker GSK (GSK.L) said on Tuesday its antibody-based COVID-19 therapy with U.S. partner Vir Biotechnology (VIR.O) is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies. The data, yet to be published in a peer-reviewed medical journal, shows that the companies' treatment, sotrovimab, is effective against all 37 identified mutations to date in the spike protein, GSK said in a statement.
7th Dec 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Dec 2021

View this newsletter in full

Canada enters deals to procure Merck and Pfizer’s Covid-19 antiviral pills

The Government of Canada has entered agreements with Merck and Pfizer to procure courses of their Covid-19 oral antiviral pills. According to the agreement with Merck (MSD), Canada will obtain 500,000 courses of the company’s oral antiviral, molnupiravir, on obtaining authorisation from Health Canada. The government also holds options to procure up to 500,000 additional courses of the pill. In June, Merck entered a deal valued at about $1.2bn with the US Government to supply molnupiravir.
6th Dec 2021 - Pharmaceutical Technology

Argentina approves Sputnik Light Covid-19 shot as standalone and booster

The Ministry of Health of Argentina has granted approval for Russia’s single-dose Sputnik Light vaccine as a standalone and a booster vaccine for Covid-19. This vaccine is based on human adenovirus serotype 26, which is also used in Russia’s Sputnik V vaccine as the first component, the Russian Direct Investment Fund (RDIF) said. According to data from 28,000 participants in Moscow, Russia, Sputnik Light given as standalone demonstrated an efficacy of 70% against Covid-19 infection from the Delta variant during the initial three months following inoculation. The shot was found to have an effectiveness of 75% in people aged below 60 years.
6th Dec 2021 - Pharmaceutical Technology

Runny-nosed hippos test positive for Covid-19 in Belgium

Two hippos at a zoo in Antwerp, Belgium, have tested positive for Covid-19, in what is believed to be the first such infection reported in the species. The hippos, named Imani and Hermien, have shown no symptoms "other than runny noses," according to a news release from the zoo. How the animals were exposed to the virus is unknown -- their caretakers have not shown any Covid-19 symptoms and all tested negative for the virus, the release said.
6th Dec 2021 - CNN

COVID-19 vaccines: Antibody levels might help speed up approval

Health authorities only approve the use of COVID-19 vaccines that have gone through rigorous clinical trials. Scientists assess whether a vaccine is effective by checking whether participants in a trial develop the infection after having the vaccine. In the present study, researchers find that a person’s antibody response could serve a correlate of effectiveness, instead of whether people develop the infection. Using this proposed measure could speed up the regulatory approval of future vaccines.
6th Dec 2021 - Medical News Today

South Africa's Biovac to start making Pfizer-BioNTech COVID-19 vaccine in early 2022 - exec

South Africa's Biovac Institute will start making Pfizer-BioNTech's, COVID-19 vaccine early next year after receiving the drug substance from Europe, a Pfizer executive said on Monday. Biovac's "fill and finish" deal with Pfizer, announced in July, will make it one of the few companies processing COVID-19 shots in Africa, where many countries have struggled to access sufficient doses during the pandemic. "We expect that the Cape Town facility will be incorporated into our supply chain by the end of this year," Patrick van der Loo, Pfizer regional president for Africa and the Middle East, told a conference in Kigali on vaccine manufacturing in Africa.
6th Dec 2021 - Reuters

Novartis working on pan-coronavirus oral treatment, CEO says

Novartis hopes to still play a role in the development of COVID-19 treatments with research ongoing for a pill that could work broadly against coronaviruses, not just the one that causes COVID-19, chief executive Vas Narasimhan told Reuters. In an interview following his recent presentation at Total Health last week, the head of the Swiss drugmaker pointed to Novartis' manufacturing support to COVID-19 vaccine and drug makers when asked if it had been on the sidelines during the pandemic. "Now I would have loved for some of our own clinical trials to have worked out, but they didn't. I mean, that's part of the deal," Narasimhan said.
6th Dec 2021 - Reuters

Next pandemic could be more lethal than COVID, vaccine creator says

Future pandemics could be even more lethal than COVID-19 so the lessons learned from the outbreak must not be squandered and the world should ensure it is prepared for the next viral onslaught, one of the creators of the Oxford-AstraZeneca vaccine said. The novel coronavirus has killed 5.26 million people across the world, according to Johns Hopkins University, wiped out trillions of dollars in economic output and turned life upside down for billions of people. "The truth is, the next one could be worse. It could be more contagious, or more lethal, or both," Sarah Gilbert said in the Richard Dimbleby Lecture, the BBC reported. "This will not be the last time a virus threatens our lives and our livelihoods."
6th Dec 2021 - Reuters

Gilead recalls 2 lots of COVID-19 drug Veklury after finding glass particulates in vials

Gilead Sciences' surprise blockbuster Veklury has braved its share of efficacy critiques. Now, the drug has run up against a manufacturing glitch. Gilead is recalling two lots of the COVID-19 antiviral Veklury, also known as remdesivir, after a customer complaint flagged the presence of glass particulates. Gilead confirmed the complaint through its own investigation, the company said Friday. Veklury was among the vanguard of COVID-19 treatments last year. It remains the first and only coronavirus med to snag a full FDA approval. Despite questions about its efficacy, the antiviral has enjoyed a resurgence in the second half of 2021 thanks to the spread of virus variants and elevated hospitalization rates.
6th Dec 2021 - FiercePharma

AstraZeneca weighs spinning out COVID-19 products into separate company

AstraZeneca recently bundled its COVID-19 vaccine and antibody treatment into a separate division. But there’s a chance that the new unit might not stay with it for long. The British drugmaker is considering the potential listing of the newly created vaccines and immune therapies division into a separate entity as part of a review of the best path forward, Bloomberg reported, citing people with knowledge of the discussions. In a statement shared with Fierce Pharma, AstraZeneca said it has “no plans” to list the division. Separating the business would be an answer to earlier concerns that tapping into COVID-19 might have been a distraction for the company. But senior executives are evaluating various possibilities with advisers and could eventually decide against a spinoff, the people said, according to the news service.
6th Dec 2021 - FiercePharma

Mixing Pfizer, AstraZ COVID-19 shots with Moderna gives better immune response -UK study

A major British study into mixing COVID-19 vaccines has found that people had a better immune response when they received a first dose of AstraZeneca or Pfizer-BioNTech shots followed by Moderna nine weeks later, according to the results on Monday. "We found a really good immune response across the board..., in fact, higher than the threshold set by Oxford-AstraZeneca vaccine two doses," Matthew Snape, the Oxford professor behind the trial dubbed Com-COV2, told Reuters. The findings supporting flexible dosing will offer some hope to poor and middle income countries which may need to combine different brands between first and second shots if supplies run low or become unstable.
6th Dec 2021 - Reuters

Omicron may raise re-infection risk; booster protection documented

A summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Re-infection risk may be higher with Omicron variant Survivors of previous infection with the virus that causes COVID-19, known as SARS-CoV-2, may be at higher risk for re-infection with the Omicron variant than with earlier versions of the virus, according to preliminary findings.
6th Dec 2021 - Reuters

Early data from South Africa hints Omicron variant may cause less severe Covid, but more research is needed

As the world waits for studies that give a clear picture of the Omicron variant, early clinical data emerging from South Africa hint at a virus that may cause less severe cases of Covid-19. The South African Medical Research Council posted a report Saturday of the early experiences at several hospitals in Gauteng Province, where Omicron was first spotted in the country. Strikingly, most hospitalized patients who tested positive for Covid did not need supplemental oxygen. Few developed Covid pneumonia, few required high-level care, and fewer still were admitted to intensive care.
4th Dec 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Dec 2021

View this newsletter in full

Covid Therapy News and Research: Brii Says 80% Cut of Hospitalization

Brii Biosciences Ltd. said additional results of a late-stage study of a Covid-19 therapy confirmed a significantly reduced risk of death and hospitalization. The topline data readout from the National Institutes of Health-sponsored trial showed combined hospitalization and death risk cut by 80% for “non-hospitalized Covid-19 patients at high risk of clinical progression,” the Chinese company said in a Hong Kong stock exchange filing Sunday. That’s was in line with a 78% reduction disclosed in August, based on an interim analysis. In-vitro testing data suggest the therapy is able to treat those with Covid-19 variants including delta, Brii said, while efforts are ongoing to determine effects against the emerging omicron variant.
5th Dec 2021 - Bloomberg

Lilly’s Covid-19 Antibody Treatment Authorized for Use in Children

Eli Lilly & Co.’s monoclonal antibody drug has been cleared for emergency use in children under the age of 12, the Food and Drug Administration said on Friday. The authorization is the first for an antibody drug to treat young children, including newborns, who have tested positive for Covid-19 or been exposed to the virus and who are at high risk of developing severe cases including hospitalization or death. “Now all patients at high risk of severe Covid-19, including children and newborn babies, have an option for treatment and post-exposure prevention,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. Children under one year of age who are exposed to the virus that causes Covid-19 may be at particularly high risk of severe disease, said Dr. Cavazzoni. She emphasized, however, that antibody drug treatment isn’t a substitute for vaccination, which is authorized for children five years of age and up.
5th Dec 2021 - The Wall Street Journal

Omicron Mutations Signal Vaccine Evasion, But Similar Symptoms

As fears of another global surge of Covid-19 cases send jitters through global markets, spur a new round of travel bans and cause Americans to rethink their holiday plans, scientists studying the omicron variant are getting the first hints of what’s in store for the months to come. The new variant’s mutations suggest that it is likely to evade the protections of vaccines to at least some extent, but that it is unlikely to cause more severe illness than previous versions of the coronavirus. These early hypotheses appear in line with real-world observations from places like South Africa, where infections have included the vaccinated and previously ill but appear so far largely mild.
5th Dec 2021 - Bloomberg

Omicron variant may have picked up a piece of common-cold virus

The Omicron variant of the virus that causes COVID-19 likely acquired at least one of its mutations by picking up a snippet of genetic material from another virus - possibly one that causes the common cold - present in the same infected cells, according to researchers. This genetic sequence does not appear in any earlier versions of the coronavirus, called SARS-CoV-2, but is ubiquitous in many other viruses including those that cause the common cold, and also in the human genome, researchers said.
4th Dec 2021 - Reuters

Omicron Cases at Norway Christmas Party Provide Clues on New Variant’s Spread

An Omicron outbreak at a Norwegian Christmas party is providing an early, if still anecdotal, data point on the ease through which the new variant spreads between vaccinated people, and how mild its symptoms at times can be. Before Scatec AS A, a Norway-based renewable-energy company, hosted the annual holiday party, it took all the major safety precautions, said Stian Tvede Karlsen, a company spokesman. Only vaccinated employees were invited. All had to take a rapid test the day before. The party, at Louise, an upscale Oslo restaurant serving seafood and Scandinavian fare, included about 120 people, several of whom had just returned from South Africa, where the company has a solar-panel project. More than half of those present have since tested positive for Covid-19, with at least 13 confirmed to have the new variant in what appears to be the world’s biggest Omicron outbreak outside southern Africa—and a glimpse into how it fares in a highly-vaccinated population.
4th Dec 2021 - The Wall Street Journal

Most Covid Vaccines Will Work as Boosters, Study Suggests

People looking for a booster shot of a Covid-19 vaccine probably don’t need to fret about what brand it is: Many combinations of shots are likely to provide strong protection, according to a large new study. In a comparison of seven different vaccine brands, British researchers found that most of them prompted a strong immune response, with the mRNA shots from Moderna and Pfizer-BioNTech eliciting the largest responses. The study was published on Thursday in The Lancet. These are welcome data for policymakers,” said Merryn Voysey, a statistician at the University of Oxford who was not involved in the study. “The most significant take-home message here is that there are a large number of excellent boosting options for third doses.”
3rd Dec 2021 - The New York Times

Key Omicron Findings May Be Known in Days, WHO Scientist Says

Urgent studies to understand how effective Covid vaccines are against omicron have begun in a global collaboration that may yield answers in a few days, a World Health Health Organization scientist said. Some 450 researchers around the world have begun work to isolate the highly mutated variant from patient specimens, grow it in the lab, verify its genomic sequence, and establish methods to test it in blood-plasma samples, said Ana-Maria Henao-Restrepo, who co-leads the WHO’s research and development blueprint for vaccines and innovations during outbreaks and pandemics.
3rd Dec 2021 - Bloomberg

How Scientists Race Against Omicron and Future Variants

What happens when two nasty Covid-19 variants get together and share their most effective mutations? Omicron and delta have brought us closer to the answer, says Peter White, a virologist at the University of New South Wales who warns of the inevitability of a new Covid-19 "super strain." He joined Stephanie Topp, a global public health expert at James Cook University in Townsville, Australia, and Bloomberg Opinion columnist David Fickling for a Twitter Spaces discussion on the implications of the newest coronavirus variant shaking up the world. Leading the conversation, which has been lightly edited for length and clarity, is Bloomberg Opinion columnist Anjani Trivedi.
3rd Dec 2021 - Bloomberg

WHO's top scientist says Omicron could displace Delta

The World Health Organization's chief scientist told the Reuters Next conference on Friday the Omicron variant could become dominant because it is highly transmissible, but that a different vaccine may not be needed. Soumya Swaminathan also said it was too early to say whether Omicron is milder than other variants of the coronavirus that causes COVID-19 and cast doubt over its origin, saying it was far from certain it emerged in southern Africa. "It is possible that it could become (the) dominant variant," Swaminathan said, adding that it was however impossible to predict. The Delta variant now accounts for 99% of infections globally, she said.
3rd Dec 2021 - Reuters

BioNTech CEO says vaccine upgrade on the cards, ready to move quickly

BioNTech should be able to adapt its coronavirus vaccine relatively quickly in response to the Omicron variant, and the next few weeks will show how urgently an upgrade is needed, its CEO Ugur Sahin told the Reuters Next conference on Friday. Sahin said people should continue to seek the established shot, developed with Pfizer as it very likely continues to protect against severe disease. "I believe in principle at a certain timepoint we will need a new vaccine against this new variant. The question is how urgent it needs to be available," Sahin said.
3rd Dec 2021 - Reuters

Slovakia's COVID-19 case record inflated by system glitch

Slovakia reported 15,278 new COVID-19 cases on Friday, the highest number in a single day since the pandemic broke out, but the Health Ministry said a technical issue inflated the number. "The reason for today's high number of positive test results is additional data, which did not pass from laboratories to the information system on Nov. 30," the ministry said. The ministry did not specify the actual number of cases detected on Thursday. The country of 5.5 million has 3,404 people hospitalised with the illness, including 630 in intensive care.
3rd Dec 2021 - Reuters

Valneva says no conclusions to be drawn on its COVID shot from UK booster study

French biotech firm Valneva said on Friday no conclusions should be drawn on the effectiveness of its COVID-19 vaccine by a British study, which found it was the only shot out of seven that offered no immunity boost when given to people previously immunized with Pfizer's vaccine. Shares in Valneva fell by up to 24% on Friday following the publication of results of Britain's COV-Boost study, which looked at the effectiveness of alternative vaccines as boosters for people who previously received Pfizer or AstraZeneca shots.
3rd Dec 2021 - Reuters

WHO chief scientist urges people not to panic over Omicron

The International Monetary Fund is likely to lower its global economic growth estimates due to the new Omicron variant of the coronavirus, the global lender's chief said at the Reuters Next conference on Friday in another sign of the turmoil unleashed by the ever-changing pandemic. Omicron has spread rapidly to at least 40 countries since it was first reported in South Africa last week, officials say, and many governments have tightened travel rules to try to keep it out
3rd Dec 2021 - Reuters

Omicron likely less severe due to vaccine, prior infection: India

India’s health ministry says the severity of COVID-19 disease from the Omicron variant in the country could be low due to vaccination and widespread exposure to the Delta variant that infected nearly 70 percent of the population by July. “Given the fast pace of vaccination in India and high exposure to Delta variant as evidenced by high seropositivity, the severity of the disease is anticipated to be low,” it said in a statement on Friday.
3rd Dec 2021 - Aljazeera.com

Germany: 1 in 100 infected with virus, health minister says

Germany's health minister said Friday that more than 1% of the population is currently infected with the coronavirus, and he called on citizens to get vaccinated if they haven't done so yet. The country confirmed 74,352 new daily COVID-19 cases and 390 additional deaths, figures published by the federal disease control agency showed . According to the Robert Koch Institute's calculations, some 925,800 people in Germany are considered actively infected with the virus.
3rd Dec 2021 - The Associated Press on MSN.com

‘The fire that’s here’: US is still battling delta variant

While all eyes are on the new and little-understood omicron variant that is popping up around the country, the delta form of the coronavirus isn’t finished wreaking havoc in the U.S., swamping hospitals with record numbers of patients in the Midwest and New England. “Omicron is a spark that’s on the horizon. Delta variant is the fire that’s here today,” said Dr. Nirav Shah, director of the state Center for Disease Control and Prevention in Maine, where an unprecedented 334 people were in the hospital with COVID-19 as of midweek. The U.S. recorded its first confirmed omicron infection on Wednesday, in a Californian who had been to South Africa, where the variant was first identified a week ago. Several more cases were reported Thursday — five in the New York City area and one each in Minnesota, Hawaii and Colorado — under circumstances suggesting the variant has begun spreading within the U.S.
3rd Dec 2021 - The Associated Press

WHO says measures used against delta should work for omicron

Measures used to counter the delta variant should remain the foundation for fighting the coronavirus pandemic, even in the face of the new omicron version of the virus, World Health Organization officials said Friday, while acknowledging that the travel restrictions imposed by some countries may buy time. While about three dozen countries worldwide have reported omicron infections, including India on Thursday, the numbers so far are small outside of South Africa, which is facing a rapid rise in COVID-19 cases and where the new variant may be becoming dominant. Still, much remains unclear about omicron, including whether it is more contagious, as some health authorities suspect, whether it makes people more seriously ill, or whether it can evade vaccine protection.
3rd Dec 2021 - The Associated Press

BioNTech CEO says likelihood of annual COVID-19 vaccines increasing

The likelihood that people will need to have an annual COVID-19 vaccine, similar to the influenza shot, is increasing, German company BioNTech, chief executive and co-founder Ugur Sahin told the Reuters Next conference on Friday.
3rd Dec 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Dec 2021

View this newsletter in full

Italy approves Pfizer and BioNTech’s Covid-19 vaccine for children

The Italian Medicines Agency (AIFA) has approved the use of the Pfizer and BioNTech Covid-19 vaccine, Comirnaty, for children aged five to 11 years. The Covid-19 vaccine is approved to be administered in two doses at a gap of three weeks. The dosage for this age group is indicated to be a third of the authorised 30µg dose given to adults and adolescents. AIFA’s Technical Scientific Commission (CTS) noted that the vaccine showed a high efficacy level with no warning signals highlighted in terms of safety, according to the data submitted by the companies. The CTS stated that “although SARS-CoV-2 infection is certainly more benign in children, in some cases it can be associated with serious consequences, such as the risk of developing multisystem inflammatory syndrome (MIS-c), which may also require hospitalisation in intensive care.”
2nd Dec 2021 - Pharmaceutical Technology

New Covid-19 drug Sotrovimab that could be effective against the Omicron variant approved by regulators

The Medicines and Healthcare products Regulatory Agency has authorised the drug for use in people with mild to moderate Covid-19 symptoms but who are at a higher risk of developing severe disease. Work will now be done to see if the drug will be effective against the new Omicron strain,
2nd Dec 2021 - iNews

COVID-19: 'Trigger' behind extremely rare AstraZeneca vaccine blood clots may have been discovered

Scientists led by a team from Arizona State University and Cardiff University worked with AstraZeneca to investigate the causes of thrombosis with vaccine-induced immune thrombocytopenia (VITT). TTS, which involves the formation of blood clots, is a life-threatening condition seen in a very small number of people after receiving the Oxford-AstraZeneca or Johnson & Johnson vaccines. The scientists say they now believe they have identified how a protein in the blood is attracted to a key component of the vaccine.
2nd Dec 2021 - Sky News

Covid-19 variants may not evolve to be less dangerous, says Neil Ferguson

People should not assume that Covid will evolve to become a milder disease, a senior scientist has warned, adding that the threat posed by the Omicron coronavirus variant will not be clear until the end of December. Prof Neil Ferguson, head of the disease outbreak analysis and modelling group at Imperial College London, told MPs on Wednesday that while evolution would drive Covid to spread more easily the virus might not become less dangerous. “Most of the transmission has already happened by the time people get hospitalised,” Ferguson told the Commons science and technology committee. “The virus cares about replicating very fast within the respiratory tract and getting out into the environment. If that happens to kill somebody 10 days later the virus really doesn’t care.”
2nd Dec 2021 - The Guardian

Pfizer begins application for Canada's approval of COVID-19 pill

Pfizer Inc said it had started the real-time submission of its application seeking Health Canada's approval of its oral COVID-19 antiviral drug candidate. The pill, PF-07321332, is designed to block a key enzyme needed for the coronavirus to multiply. The move comes after the Canadian government announced that it was in advanced talks with Pfizer and Merck & Co Inc regarding a purchase agreement for their COVID-19 antiviral drugs, as the country attempts to control the spread of the Omicron coronavirus variant.
2nd Dec 2021 - Reuters

Cuba to upgrade homegrown COVID-19 vaccine to confront Omicron

Cuban health authorities said that researchers in the communist-run country are upgrading its homegrown COVID vaccines to ensure protection against the new Omicron variant. The Caribbean island nation, whose economy hinges on tourism, sharply eased entry requirements in mid-November following a successful inoculation drive with domestically developed vaccines. Both infections and deaths from COVID-19 have dropped off to 2% or less of their peaks, according to a Reuters tally.
2nd Dec 2021 - Reuters

S.African data suggests Omicron gets around some, not all immunity

The Omicron variant appears able to get around some immunity but vaccines should still offer protection against severe disease, according to the latest data from South Africa where it is fast overtaking Delta to become the dominant variant.
2nd Dec 2021 - Reuters

EU regulator begins real-time review of Valneva's COVID-19 shot

The European Union's drug regulator said on Thursday it had started a rolling review of the inactivated-virus COVID-19 vaccine from French biotech firm Valneva, weeks after the EU signed a deal with the company for supplies of the shot. The decision to start the real-time review was based on preliminary studies that suggest the vaccine, VLA2001, triggers an antibody response against the coronavirus, the European Medicines Agency (EMA) said.
2nd Dec 2021 - Reuters

China accelerating research into COVID-19 shots targeting Omicron -state media

China is accelerating research and development of COVID-19 vaccines targeting the Omicron variant, a health official said on Thursday, amid concerns among global scientists that it may spread more quickly than other strains. Mainland China has not detected any Omicron case yet. "We are rapidly pushing forward the research and development of Omicron-specific vaccines based on different technologies," Zheng Zhongwei, who heads a group tasked with COVID-19 vaccine development in China, told state broadcaster CCTV.
2nd Dec 2021 - Reuters

Britain approves GSK-Vir antibody-based COVID-19 treatment

Britain's drug regulator on Thursday approved GSK and Vir Biotechnology's antibody based COVID-19 treatment, Xevudy, for people with mild-to-moderate COVID-19 who are at high risk of developing severe disease. The approval comes as GSK separately announced the treatment has shown to work against the Omicron variant.
2nd Dec 2021 - Reuters

Severe COVID tied to high risk of death, mostly by other causes, within year

Survivors of severe COVID-19—especially those younger than 65 years—may be at more than twice the risk of dying within the next year than those who had mild or moderate illness or were never infected, finds a study today in Frontiers in Medicine. Another finding of the analysis of electronic health records of 13,638 patients who tested positive or negative for COVID-19 is that only 20% of those who had severe COVID-19 (requiring hospitalization) and died did so because of complications of their infection, such as abnormal blood clotting, respiratory failure, or cardiovascular problems. Rather, 80% were due to different reasons typically considered unrelated to COVID-19. "Since these deaths were not for a direct COVID-19 cause of death among these patients who have recovered from the initial episode of COVID-19, this data suggests that the biological insult from COVID-19 and physiological stress from COVID-19 is significant," wrote the University of Florida at Gainesville researchers.
2nd Dec 2021 - CIDRAP

Aspen Pharmacare, pursuing J&J vaccine license, aims to shore up local capacity and quash shot inequality in Africa

History is repeating for Aspen Pharmacare. Nearly 20 years ago, as Africa grappled with an HIV epidemic, Aspen pioneered the first generic antiretroviral on the continent. Now, it has a chance to do something similar with Johnson & Johnson's COVID-19 vaccine. This time, however, the South African drugmaker's contribution could be even more of a "game changer," thanks to the scope of the pandemic and the disproportionate toll it's taken on Africa, an Aspen executive told Fierce Pharma. Aspen earlier this week signed a nonbinding term sheet with two J&J subsidiaries in a bid to license and sell the company's single-dose COVID-19 vaccine in Africa. The potentially "monumental" agreement is big for two reasons, Stavros Nicolaou, Ph.D., group senior executive of strategic trade at Aspen Pharma Group, said in an interview.
2nd Dec 2021 - FiercePharma

Another fight for Covid long-haulers: having their pain acknowledged

After his second hospitalization for acute Covid-19, Tony Marks expected to get better. Then pain invaded the 54-year-old software executive’s arms and legs. At first, he felt like he was covered by deep bruises, although nothing was visible on his skin. These days, he told me, he feels like he’s being beaten repeatedly with a baseball bat. Pain is increasingly being recognized as a key feature of what is commonly called long Covid, in which symptoms persist after the acute phase of the viral infection ends. In a recent study from Italy, for example, one-third of Covid long-haulers had symptoms of fibromyalgia or widespread muscle or bone pain. Other research links Covid-19 to neuropathic pain — often described as burning, stabbing, or feeling like electrical shocks — that results from damage to the nervous system. Pain, which also includes headache, ranks among the top symptoms of long Covid in large longitudinal studies.
2nd Dec 2021 - STAT News

Some experts suggest Omicron variant may have evolved in an animal host

When Covid-19 variants arise, the accepted wisdom is that the constellation of mutations they contain developed in an immunocompromised person who contracted the virus and couldn’t shake the infection. But some scientists have an alternative theory for where the latest variant of concern, Omicron, may have acquired the unusual mutations that stud its spike protein. They speculate the virus could have evolved in another animal species. The theory goes that some type of animal, potentially rodents, was infected with the SARS-CoV-2 virus sometime in mid-2020. In this new species, the virus evolved, accumulating roughly 50 mutations on the spike protein before spilling back over into people.
2nd Dec 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Dec 2021

View this newsletter in full

COVID-19: Most Omicron cases are 'mild' and there's no evidence to suggest vaccines may be less effective against the variant, says WHO official

Early indications suggest most Omicron coronavirus cases are "mild", an official at the World Health Organisation (WHO) has said. Speaking on behalf of the organisation, the official said there is no evidence to suggest the efficacy of vaccines has been reduced by the new strain - but did say some mutations of the virus indicate an increased risk of quicker transmission. They said more than 40 different mutations have been identified with the Omicron variant. The WHO official, quoted by Reuters, added there is still a lot unknown about the new strain.
1st Dec 2021 - Sky News

COVID-19: NERVTAG scientists 'can't rule out' Omicron causing biggest wave of infections yet that may overwhelm NHS

The Omicron variant could trigger a surge in COVID infections bigger than previous waves in the UK with a risk it may overwhelm the NHS, a key group of scientists have warned. Experts on the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), which advises the government, held an extraordinary meeting last week to consider the new COVID variant, known scientifically as B.1.1.529, following its detection in South Africa. According to a note of their meeting, which was observed by both a key Department of Health official and England's deputy chief medical officer Jonathan Van-Tam, the group concluded the introduction of Omicron to the UK "might have very serious consequences".
1st Dec 2021 - Sky News

Severe Covid infection doubles chances of dying in following year, study finds

Patients who survive severe Covid are more than twice as likely to die over the following year than those who remain uninfected or experience milder virus symptoms, a study says. The research, published in Frontiers in Medicine, suggests that serious coronavirus infections may significantly damage long-term health, showing the importance of vaccination. The increased risk of dying was greater for patients under 65, and only 20% of the severe Covid-19 patients who died did so because of typical Covid complications, such as respiratory failure.
1st Dec 2021 - The Guardian

Philippines says COVID variants highlight need for local vaccine development

New coronavirus variants highlight the need for countries to do their own research and development on COVID-19 vaccines, said a senior Philippines trade official, adding that people will only be safe once the whole world is vaccinated. The Philippines is looking to work with its trading partners on this as vaccine demand is unlikely to wane anytime soon, said Allan Gepty, assistant secretary at the Department of Trade and Industry in an interview at the Reuters Next conference. The new COVID-19 variants highlight that "we have to continue doing our respective research and development in this area because there is a truism that …no one is safe unless everyone is safe," said Gepty.
1st Dec 2021 - Reuters

BioNTech CEO says vaccine likely to protect against severe COVID from Omicron

BioNTech and Pfizer's COVID-19 vaccine will likely offer strong protection against any severe disease from the new Omicron virus variant, BioNTech's Chief Executive told Reuters, as the firm weighs the need to upgrade its commonly used shot. Lab tests are underway over the next two weeks to analyse the blood of people who had two or three doses of BioNTech's Comirnaty vaccine to see if antibodies found in that blood inactivate Omicron, shedding light on whether new vaccines are needed.
1st Dec 2021 - Reuters

Regeneron's COVID-19 antibody drug may be less effective against Omicron

Regeneron Pharmaceuticals Inc's COVID-19 antibody drug could be less effective against Omicron, it said on Tuesday, adding to fears about the efficacy of existing treatments after Moderna's top boss raised similar concerns about the company's vaccine. Global markets tumbled after comments from Moderna's chief executive officer rekindled worries that the variant may weigh on a nascent global economic recovery.
1st Dec 2021 - Reuters

U.S. FDA panel narrowly backs Merck's at-home COVID-19 pill

A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's (MRK.N) antiviral pill to treat COVID-19. If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency. Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.
1st Dec 2021 - Reuters

WHO members agree to start drafting global pandemic convention

Member states of the World Health Organization (WHO) have agreed to start drafting a global agreement to prevent and tackle the next global pandemic. Countries adopted a resolution on Wednesday at a special meeting in Geneva, launching the process that it is hoped should result in a new agreement on pandemics.
1st Dec 2021 - AlJazeera

Weak immune systems tied to more COVID-19 breakthrough infections

While COVID-19 breakthrough infections—cases after vaccination—are rare, fully vaccinated people with compromised immune systems have them three times more often than those with strong immune systems and have more severe illnesses, according to a real-world US study involving nearly 1.3 million people. In the retrospective study, published today in the Journal of Medical Economics, a team led by researchers from Pfizer analyzed the health records of 1,277,747 people aged 16 or older who had received two doses of the Pfizer/BioNTech COVID-19 vaccine from Dec 10, 2020, to Jul 8, 2021. The latter part of the study period included the emergence of the Delta (B1617.2) variant in the United States.
1st Dec 2021 - CIDRAP

Merck's COVID-19 antiviral narrowly clears FDA panel—but committee echos support for revoking nod in favor of superior option

Merck and Ridgeback’s recent report that its antiviral molnupiravir wasn’t nearly as effective as previously indicated put a damper on enthusiasm that a game-changing oral treatment for COVID-19 was near. It also drew questions at the FDA on whether to approve the pill on an emergency use basis at all. On Tuesday, an FDA advisory committee voted by the narrow margin of 13-10 to endorse the use of molnupiravir. The recommendation comes despite a host of concerns, including over the efficacy and safety of the antiviral medicine. “In my many years of chairing this committee, this is the first meeting that has gone over (its time limit), which I think speaks to the complexity of the issues,” said Lindsey Baden, M.D., of the Brigham and Women’s Hospital of Boston.
1st Dec 2021 - FiercePharma

A reason for optimism on Omicron: Our immune systems are not blank slates

The emergence of a new Covid-19 variant with a startlingly large constellation of mutations has countries around the world sounding alarms. While the concerns are understandable, experts in immunology say people need to remember a critical fact: Two years and 8 billion vaccine doses into the pandemic, many immune systems are no longer blank slates when it comes to SARS-CoV-2. The new SARS-2 variant, known as Omicron, may more easily sidestep some of the immunity of some vaccinated and previously infected people. But there’s good reason to think people who already have some immune protections may avoid the worst of what Covid infections can do to immunologically naïve people.
1st Dec 2021 - STAT News

Pfizer research head envisions a sprint to develop Omicron vaccine, if it’s needed

A top Pfizer executive says the company is hopeful that booster shots will provide sufficient protection against the Omicron variant — but has already envisioned a timeline for the development of a new vaccine if that’s not the case. Mikael Dolsten, Pfizer’s chief scientific officer, likened the company’s researchers to firefighters: They don’t know how serious the blaze will be, but need to prepare for the worst. And in this case, the worst would mean the need to develop new vaccines. “We do take the new variant of concern, Omicron, with seriousness,” Dolsten told STAT. “It can indeed be a potential new threatening wave … although we don’t know that yet. But we always start with being prepared for the worst.”
1st Dec 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Dec 2021

View this newsletter in full

Testing, vaccines, sequencing: experts call for multi-pronged approach to Omicron

As new cases of the Omicron coronavirus variant are uncovered across the globe and threaten to spread in America, US officials are reacting by urging vaccinations and boosters instead of imposing restrictions which have increasingly provoked political fights. But the US should quickly invest in other tools as well, experts said, including testing, genomic sequencing and surveillance, better communication, and a strong focus on global vaccine equity to prevent the emergence of new variants. All of that would prepare America better to deal with a variant that many experts suspect is probably already inside the country, even if undetected so far.
30th Nov 2021 - The Guardian

UAE approves Sputnik Light as universal booster shot against COVID-19 - RDIF

The United Arab Emirates has approved Russia's Sputnik Light vaccine as a universal booster shot against COVID-19, Russian sovereign wealth fund RDIF said on Tuesday. The Russian Direct Investment Fund, which markets the vaccine abroad, said Sputnik Light can be administered six months after the second dose of any other vaccine used in the United Arab Emirates.
30th Nov 2021 - Reuters

Becton confident its COVID-19 tests will detect Omicron variant

Becton Dickinson and Co (BDX.N) said on Tuesday it was confident that its COVID-19 tests would be able to detect the new coronavirus variant Omicron. The company sells a variety of tests for COVID-19, including antigen and PCR tests. In October, it started shipping at-home rapid COVID-19 tests in the United States that can confirm results using an entirely automated smartphone app. Becton also said it had conducted analyses of the variant using all available genome sequences from the Global Initiative on Sharing All Influenza Data (GISAID) — the largest database of novel coronavirus genome sequences in the world.
30th Nov 2021 - Reuters

Regeneron says its COVID-19 antibody drug could be less effective against Omicron

It is high time we start preparing for future pandemics

Five million lives worldwide have already been lost to COVID-19, and the World Health Organization Access to COVID-19 Tools Accelerator (WHO/ACT-A) grimly predict five million more lives will be lost to the disease in months to come. Alarmingly also, COVID-19 cases will swell from the 260 million confirmed so far to 460 million by the end of 2022. The damage from COVID-19 has been so catastrophic that, when the World Health Assembly (WHA) meets in a special session, starting November 29, its task is nothing less than preventing such a tragedy from re-occurring. The damage from COVID-19 has been so ruinous that we now need an internationally binding agreement to prevent future outbreaks from ever becoming pandemics again.
30th Nov 2021 - Aljazeera.com

Pfizer now expects to produce 80 mln courses of COVID-19 pill, CEO tells CNBC

Pfizer Inc now expects to manufacture 80 million treatment courses of its experimental COVID-19 antiviral drug, up from a previous forecast of 50 million, Chief Executive Officer Albert Bourla said in a CNBC interview on Monday. Earlier this month, Pfizer said it expects to manufacture 180,000 treatment courses by the end of this year and at least 50 million courses by the end of next year, including 21 million in the first half of 2022. "We can right now commit to 80 million doses ... thanks to our manufacturing machine," Bourla told CNBC.
30th Nov 2021 - Reuters

EU could approve shot against new Covid variant in 3-4 months

The EU drug regulator said on Tuesday it could approve vaccines adapted to target the Omicron variant of the coronavirus within three to four months if needed, but that existing shots would continue to provide protection. Speaking to the European Parliament, European Medicines Agency (EMA) executive director Emer Cooke said it was not known if drugmakers would need to tweak their vaccines to protect against Omicron, but the EMA was preparing for that possibility.
30th Nov 2021 - Reuters

U.S. FDA panel to weigh Merck's COVID-19 antiviral drug

A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's antiviral pill to treat COVID-19. If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency. Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.
30th Nov 2021 - Reuters

COVID-19 vaccine makers start work on Omicron-tailored shots

BioNTech, Moderna and Johnson & Johnson are working on vaccines that specifically target Omicron in case their existing shots are not effective against the new coronavirus variant, the companies said on Monday. The variant's emergence has triggered a strong global response as countries worried that it could spread fast even in vaccinated populations impose travel curbs and other restrictions. BioNTech SE said it had started work on a vaccine tailored to Omicron, along with partner Pfizer
30th Nov 2021 - Reuters

COVID-19 reinfection less likely to be severe; cardiac stress test useful for unexplained lingering breathlessness

Reinfections with the virus that causes COVID-19 are rarely severe, new findings suggest. Researchers in Qatar compared 1,304 individuals with a second SARS-CoV-2 infection with 6,520 people infected with the virus for the first time. The odds of developing severe disease were 88% lower for people with second infections, the researchers reported online on Wednesday in The New England Journal of Medicine.
30th Nov 2021 - Reuters

Celltrion signs COVID-19 antibody therapy supply deals with Europe

South Korean biotech company Celltrion's distribution arm has signed supply deals for its monoclonal antibody to treat COVID-19 with nine European countries, Celltrion Healthcare said on Tuesday. The European Commission earlier this month approved the company's antibody therapy Regkirona, granting marketing authorisation for adults with COVID-19 who are at increased risk of progressing to a severe condition. The first batch of 50,000 doses will be shipped to Europe this year and the company is in talks with 47 other nations including in Asia, Central and South America and the Middle East, Celltrion said in a statement.
30th Nov 2021 - Reuters

WHO warns that new virus variant poses 'very high' risk

The World Health Organization warned Monday that the global risk from the omicron variant is “very high” based on the early evidence, saying the mutated coronavirus could lead to surges with “severe consequences.” The assessment from the U.N. health agency, contained in a technical paper issued to member states, amounted to WHO’s strongest, most explicit warning yet about the new version that was first identified days ago by researchers in South Africa. It came as a widening circle of countries around the world reported cases of the variant and moved to slam their doors in an act-now-ask-questions-later approach while scientists race to figure out just how dangerous the mutant version might be. Japan announced it is barring entry to all foreign visitors, joining Israel in doing so. Morocco banned all incoming flights. Other countries, including the U.S. and members of the European Union, have moved to prohibit travelers arriving from southern Africa.
30th Nov 2021 - The Associated Press

US tracking of virus variants has improved after slow start

After a slow start, the United States has improved its surveillance system for tracking new coronavirus variants such as omicron, boosting its capacity by tens of thousands of samples per week since early this year. Viruses mutate constantly. To find and track new versions of the coronavirus, scientists analyze the genetic makeup of a portion of samples that test positive. They’re looking at the chemical letters of the virus’s genetic code to find new worrisome mutants, such as omicron, and to follow the spread of known variants, such as delta. It’s a global effort, but until recently the U.S. was contributing very little. With uncoordinated and scattershot testing, the U.S. was sequencing fewer than 1% of positive specimens earlier this year. Now, it is running those tests on 5% to 10% of samples. That’s more in line with what other nations have sequenced and shared with global disease trackers over the course of the pandemic.
30th Nov 2021 - The Associated Press

Final US hurdle for Merck’s COVID-19 pill: FDA panel review

A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. The Food and Drug Administration panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. “I see this as an incredibly difficult decision with many more questions than answers,” said panel chair Dr. Lindsey Baden of Harvard Medical School, who voted in favor of the drug. He said FDA would have to carefully tailor the drug’s use for patients who stand to benefit most.
30th Nov 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Nov 2021

View this newsletter in full

India's Bharat Biotech resumes exports of COVID-19 vaccine

Indian vaccine maker Bharat Biotech said on Monday it has resumed export of its COVID-19 shot, Covaxin, and has executed long-pending orders in November. The company also said exports to additional countries will commence from December, according to a statement it shared on Twitter. It was not immediately clear whether or not these exports were made under the global vaccine-sharing facility COVAX.
29th Nov 2021 - Reuters

Could the Omicron variant have been avoided? It could set back vaccine successes around the world

I am an epidemiologist working in global health, and have worked in the field of vaccines for nearly 15 years. While the scientific successes of Sars-CoV-2 vaccine development have been surreal, the inequity of the pandemic and access to vaccines has left me despondent. As Australia reaches almost 90% coverage for two doses of Covid-19 vaccination, it’s a success story worth celebrating. Covid-19 vaccination has already proved to be highly effective at dampening wide-scale community transmission in settings such as New South Wales, where a rapid rollout with high levels of first-dose coverage along with other public health measures helped with the bending of the curve. But the vast majority of low- and middle-income countries have only vaccinated a small proportion of their population. An analysis suggests that while 66% of people in high-income countries are fully vaccinated, only 2.5% of the population in low-income countries are fully protected.
29th Nov 2021 - The Guardian

COVID-19: How the spread of Omicron went from patient zero to all around the globe

The speed with which new variants of the COVID-19 virus spread around the world can leave governments scrambling to catch up. What is sometimes more remarkable is the speed with which those new variants are detected. It has taken barely two weeks from the initial testing of 'patient zero', before potentially the entire globe is readying itself to examine COVID test samples to see if they contain the Omicron variant. Patient zero, called n=1 or the index case by the scientific community, arrived at Hong Kong International Airport on 11 November, having flown in from South Africa via Doha in Qatar, on flight QR818.
29th Nov 2021 - Sky News

The new Omicron variant is a reminder that 'the virus is still in control' regardless of Covid-19 fatigue, medical professor says

The new Omicron variant might prompt a return to stricter Covid-19 measures if not enough people get vaccinated or boosted, health experts say. Omicron -- or the B.1.1.529 strain of novel coronavirus -- has already spurred international travel bans. The World Health Organization officially called it a "variant of concern" on Friday. The variant has not yet been detected in the US, the Centers for Disease Control and Prevention said in a Saturday update. "But it's fairly likely we'll see cases," said Dr. Francis Collins, director of the National Institutes of Health.
29th Nov 2021 - CNN

South Africa's Aspen in advanced talks over COVID-19 vaccine deal

Aspen Pharmacare is in advanced discussions over a potential licensing agreement to package the COVID-19 vaccine in South Africa, it said on Monday. The South African company did not mention the name of the company with which it was in talks, but in early September it said it was in talks with U.S. pharma giant Johnson & Johnson over a vaccine packaging licence. Aspen currently packages J&J's COVID-19 vaccine at its South African plant under contract, which means it does not have any pricing or distribution power over the product. The company currently produces 300 million COVID-19 vaccine doses annually under its J&J contract, which are then supplied across Africa. It plans to ramp up capacity to 1.3 billion doses by February 2024, Chief Executive Stephen Saad told Reuters in October
29th Nov 2021 - Reuters

BioNTech starts work on Omicron-specific vaccine

BioNTech SE said on Monday it had started work on a vaccine tailored to Omicron, the worrying new coronavirus variant detected in South Africa, though it was not yet clear if it would have to rework its established COVID-19 shot. The development of an adapted vaccine is part of the company's standard procedure for new variants, BioNTech, which makes vaccines together with Pfizer, said in a statement. "The first steps of developing a potential new vaccine overlap with the research necessary in order to evaluate whether a new shot will be needed," it added.
29th Nov 2021 - Reuters

Omicron poses very high global risk, world must prepare -WHO

The heavily mutated Omicron coronavirus variant is likely to spread internationally and poses a very high risk of infection surges that could have "severe consequences" in some places, the World Health Organization (WHO) said on Monday. No Omicron-linked deaths had yet been reported, though further research was needed to assess its potential to resist vaccines and immunity induced by previous infections, it added. Anticipating increased case numbers as the variant, first reported last week, spreads, the U.N. agency urged its 194 member states to accelerate vaccination of high-priority groups.
29th Nov 2021 - Reuters

Thermo Fisher says its COVID-19 tests accurately detects Omicron variant

Thermo Fisher Scientific Inc said on Monday its COVID-19 diagnostic tests can accurately detect the new coronavirus variant Omicron that has prompted several countries to shut their borders. The World Health Organisation (WHO) last week classified the Omicron variant as a SARS-CoV-2 "variant of concern," saying it may spread more quickly than other forms. Thermo Fisher's TaqPath COVID-19 assays can report accurate results even in the case where one of the gene targets is impacted by a mutation, the company said in a statement.
29th Nov 2021 - Reuters

Omicron brings COVID-19 vaccine inequity ‘home to roost’

The emergence of the new omicron variant and the world’s desperate and likely futile attempts to keep it at bay are reminders of what scientists have warned for months: The coronavirus will thrive as long as vast parts of the world lack vaccines. The hoarding of limited COVID-19 shots by rich countries — creating virtual vaccine deserts in many poorer ones — doesn’t just mean risk for the parts of the world seeing shortages; it threatens the entire globe. That’s because the more the disease spreads among unvaccinated populations, the more possibilities it has to mutate and potentially become more dangerous, prolonging the pandemic for everyone.
29th Nov 2021 - The Associated Press

Moderna says Omicron vaccine could be ready by early 2022

Moderna Inc. is having its best two-day rally in a year after the company said a new vaccine to fight the omicron strain of the coronavirus could be ready by early 2022 if required. The stock soared as much as 14% to the highest level in two months, after jumping 21% during Friday’s global risk-asset selloff, to reclaim its place as top performer on the S&P 500 year-to-date. The company mobilized hundreds of workers on Thanksgiving Day last Thursday in order to start work on omicron, Chief Medical Officer Paul Burton said over the weekend.
29th Nov 2021 - AlJazeera

Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback

The efficacy data for Pfizer’s oral COVID-19 drug now look so appealing that the Big Pharma company is boosting manufacturing capacity even before an expected emergency use authorization from the FDA. Pfizer now expects to make 80 million courses of COVID drug Paxlovid by the end of 2022, Pfizer CEO Albert Bourla told CNBC during a Monday interview. The company previously said it plans to have capacity to make 50 million courses.
29th Nov 2021 - FiercePharma

Pfizer, Moderna, J&J and AstraZeneca assess omicron's effect on their COVID-19 vaccines

With the new omicron strain fueling fear around the globe that the coronavirus is regaining momentum, makers of the world’s most successful vaccines are investigating whether they need to tweak their shots. Over the last few days, Moderna, Pfizer-BioNTech, Johnson & Johnson and AstraZeneca revealed plans to address the threat posed by omicron, which emerged in South Africa and recently was detected in Australia, Israel, Hong Kong and parts of Europe. On Friday, the World Health Organization classified omicron as a “variant of concern.” Each of the companies said it's testing an omicron-specific vaccine. Moderna said it could have a tweaked version of its shot ready early next year if necessary. In the case of the delta and beta variants, Moderna needed “60-90 days” to advance new candidates to clinical testing, it said in a release.
29th Nov 2021 - FiercePharma

With winter looming, cancer patients and doctors seek more Covid protection

Michele Nadeem-Baker is steeling herself for another winter. Diagnosed with chronic lymphocytic leukemia in 2012, she lives with an impaired immune system that even a third dose of Moderna’s Covid-19 vaccine may not be able to rouse. Living in Boston in November now that the weather has turned cold means an end to backyard dinners and a return to a world narrowed by fear of infection. “I am not alone in that feeling,” said Nadeem-Baker, a patient advocate who also spoke to STAT in June. “Everyone is dreading yet another winter in lockdown. Just because there are these third vaccinations, it doesn’t mean everyone is protected. There is still a part of the population that is not.”
29th Nov 2021 - STAT News

Scientists rapidly identified the Omicron variant. But firm answers about its impact could take weeks

The emergence of the Omicron variant of the coronavirus, with a suite of mutations that suggests it might be extra transmissible and be able to evade at least some immune protection, has the world eager for answers about what it means for the Covid-19 pandemic. But so much remains unknown largely because the variant appears to have been detected and publicized so quickly. With other variants, a matter of months passed between the time they were first documented until they were designated “variants of concern” — in some cases giving scientists more opportunity to understand them before they attracted widespread attention. With Omicron, initially identified as B.1.1.529, it all happened within about two weeks.
29th Nov 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Nov 2021

View this newsletter in full

Botswana says 15 more cases of Omicron variant detected in country

Botswana's health minister Edwin Dikoloti said on Sunday the country had detected 15 more cases of the Omicron coronavirus variant, adding to the four confirmed cases it declared on Friday. The minister applauded its scientists for detecting the new variant in the country early, but stressed it did not emerge in Botswana as the four cases were found in people who travelled to the country on a diplomatic mission. He declined to comment on the nationalities of the four people saying the country "would not want to add to the seeming trend where the variant is stigmatised".
28th Nov 2021 - Reuters

S.African doctor says patients with Omicron variant have "very mild" symptoms

A South African doctor who was one of the first to suspect a different coronavirus strain among patients said on Sunday that symptoms of the Omicron variant were so far mild and could be treated at home. Dr. Angelique Coetzee, a private practitioner and chair of South African Medical Association, told Reuters that on Nov. 18 she noticed seven patients at her clinic who had symptoms different from the dominant Delta variant, albeit "very mild".
28th Nov 2021 - Reuters

Omicron coronavirus variant travel bans may be too late, experts say

The Biden administration is focusing on booster shots as a key weapon in efforts to protect the nation against a potentially dangerous coronavirus variant even as the extent of the threat remains unclear, according to three senior administration officials familiar with the plans. A group of senior health officials had a call with South African scientists Sunday to understand the latest about the new variant and to help inform next steps, according to one of the senior administration officials, who, like the other two, spoke on the condition of anonymity to describe internal discussions.
28th Nov 2021 - The Washington Post

New Coronavirus Variant a ‘Serious Concern’ in South Africa

Scientists in South Africa are studying a recently identified new coronavirus variant of concern, stoking fears the country may face a potentially severe fourth wave that could spread internationally. The new discovery, called B.1.1.529 until a Greek letter is assigned to it by the World Health Organization, carries an unusually large number of mutations and is “clearly very different” from previous incarnations, Tulio de Oliveira, a bio-informatics professor who runs gene-sequencing institutions at two South African universities, said at a briefing on Thursday.
27th Nov 2021 - Bloomberg on MSN.com

Merck’s Covid-19 Pill Was 30% Effective in Final Analysis, Company Says

Merck and Ridgeback Biotherapeutics said a final analysis of their experimental Covid-19 pill found the drug less effective than an early look, prompting U.S. health regulators to continue a staff review of the drug’s application days before an outside panel meets. The Food and Drug Administration made public Friday their initial review of the drug’s application, including an analysis of clinical-trial data for the drug, molnupiravir. Agency staff said the drug was effective at reducing the risk of hospitalization and death, but they didn’t take a position on whether the agency should authorize the drug. The agency also said no major safety concerns turned up in late-stage testing. The FDA said it is still conducting its review of molnupiravir, after the companies told the agency earlier this week the pill was 30% effective in a final analysis of the late-stage study results. After taking an early look at results, the companies had reported in October that molnupiravir was 50% effective.
27th Nov 2021 - The Wall Street Journal

Omicron Coronavirus Variant Raises Questions Among Scientists

The fast-spreading Omicron coronavirus variant recently identified in South Africa has virologists and health authorities on edge because of its many mutations, but much about its infectiousness and virulence remains unknown. Scientists said some of the roughly 50 mutations on the new variant, called B.1.1.529, could potentially render it more transmissible or reduce vaccine effectiveness. But it will take time for virologists and infectious-disease researchers to study the variant’s spread and the potential impact on vaccines and therapeutics. “There are several aspects of concern here, but there are lots of unknowns,” Sharon Peacock, director of the Covid-19 Genetics U.K. Consortium, said at a press briefing on Friday. “It’s so important to stress how much we don’t know at the moment about this new variant.”
27th Nov 2021 - The Wall Street Journal

Omicron Identified as Covid-19 ‘Variant of Concern,’ Triggering Global Fears

A fast-spreading new strain of the coronavirus first detected in southern Africa is a global “variant of concern” and might pose a higher risk of people falling ill with Covid-19 for a second time, the World Health Organization said Friday, as governments around the globe restricted travel from the region. WHO said there was also preliminary evidence that the variant, which it named Omicron after the Greek letter, was more transmissible than the Delta variant that is currently dominant world-wide, and other virus strains. Health authorities in Belgium, Israel, Hong Kong and Botswana said they had detected first cases of the variant. Although scientists were still figuring out the exact effects of the variant’s many mutations, its discovery highlights the continued threat posed by an evolving virus to the world’s emergence from the pandemic. The travel restrictions imposed by many countries, including the U.S., raised fears that there could be further setbacks to the reopening of economic and social life, including in Western countries with high vaccination rates.
27th Nov 2021 - The Wall Street Journal

Belgium Confirms Case of New Virus Strain in Unvaccinated Traveler

Belgium said it has confirmed one case of a concerning new Covid-19 variant in someone who traveled from abroad. Health Minister Frank Vandenbroucke told reporters the variant was detected in an unvaccinated person who first tested positive for Covid-19 on Nov. 22. The new strain prompted the European Union on Friday to recommend suspending air travel from the region. Belgium also Friday ordered a new set of steps to combat the spiraling growth of Covid-19 cases, including a closure of nightclubs for three weeks and restricting privately organized parties.
27th Nov 2021 - Bloomberg

Scientists Racing to Decode Omicron as Defenses Buy Time

BioNTech Expects Data on Vaccine Versus New Variant in Two Weeks

BioNTech SE has begun studying the new Covid-19 variant that has emerged in southern Africa and expects the first data from laboratory tests about how it interacts with its vaccine within two weeks. The lab data will shed light on whether the new variant, called B.1.1.529, can elude the vaccine it makes together with Pfizer Inc., the German biotech said on Friday. Pfizer and BioNTech put plans in place months ago to be able to ship a new version of their shot within 100 days if necessary, a BioNTech spokeswoman said. “We understand the concern of experts and have immediately initiated investigations,” BioNTech said in a statement.
26th Nov 2021 - Bloomberg

Covid-19 Variant: Scientists Race to Decode Omicron as Strain Threatens World

Travel bans and other snap defenses that countries threw up against omicron, the new Covid-19 variant, are buying time for scientists to answer key questions that could prevent another wave of deaths. Labs in Europe, the U.S. and Africa are preparing for tests to see how the new variant is likely to behave in people who’ve been vaccinated or previously infected. Real-world research will be important too, as health authorities monitor the outbreak in South Africa closely to find out how much more transmissible the new variant will be as it spreads and whether it’s more dangerous or deadly.
26th Nov 2021 - Bloomberg

Paris makes mask wearing outdoors mandatory at public gatherings

Paris has made the wearing of face masks outside mandatory again at public gatherings as the COVID-19 infection rate in the French capital soars, police said. The police prefecture said in a statement that masks will have to be worn for gathering in public spaces, at festivals and spectacles, on markets and when standing in line.
26th Nov 2021 - Reuters

61 travellers from South Africa in Netherlands positive for COVID-19 -authorities

Dutch health authorities said that 61 people who arrived in Amsterdam on two flights from South Africa on Friday tested positive for COVID-19, and they were conducting further testing early Saturday to see if any of the infections are with the recently discovered Omicron coronavirus variant. Around 600 passengers arrived at Amsterdam's Schiphol Airport on the two KLM flights on Friday and then faced hours of delays and testing due to concerns over the new virus variant.
26th Nov 2021 - Reuters

Merck's COVID-19 pill significantly less effective in new analysis

Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported. The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
26th Nov 2021 - Reuters

Pfizer/BioNTech, Moderna expect data on shot's protection against new COVID-19 variant soon

BioNTech SE said on Friday it expects more data on a worrying new coronavirus variant detected in South Africa within two weeks to help determine whether its vaccine produced with partner Pfizer Inc would have to be reworked. Pfizer and BioNTech said that if necessary they expect to be able to ship a new vaccine tailored to the emerging variant in approximately 100 days. "We understand the concern of experts and have immediately initiated investigations on variant B.1.1.529," BioNTech said in a statement when asked to comment. "We expect more data from the laboratory tests in two weeks at the latest. These data will provide more information about whether B.1.1.529 could be an escape variant that may require an adjustment of our vaccine if the variant spreads globally," it added.
26th Nov 2021 - Reuters

Israel warns of looming emergency after its first case of omicron, new COVID-19 variant

Israel Prime Minister Naftali Bennett said on Friday that the country is “on the threshold of an emergency situation” after it detected its first case of omicron, the new South African strain of coronavirus. The Israeli Health Ministry said it detected the new strain in a traveler who had returned from Malawi, and that it is investigating two other suspected cases, The Associated Press reported. Bennett said the new variant is more contagious and spreads more rapidly than the delta variant. He added that authorities are still gathering data on how effective the coronavirus vaccines will be against the variant.
26th Nov 2021 - The Hill

COVID-19: New variant officially named Omicron and Health Secretary Sajid Javid warns of 'huge international concern' as first case found in Europe

A worrying new COVID strain has been classified by the World Health Organisation as a "variant of concern" - its most serious level - and officially given the Greek name Omicron. The WHO said the variant, first detected in South Africa and previously known as B.1.1.529, "has a large number of mutations, some of which are concerning" and early evidence suggested an increased risk of reinfection compared to other strains. "This variant has been detected at faster rates than previous surges in infection, suggesting that this variant may have a growth advantage," the organisation added.
26th Nov 2021 - Sky News

Moderna Edges Pfizer in Study of Five Covid Vaccines

The Moderna Inc. and Russian Sputnik V Covid-19 vaccines both edged the version from Pfizer Inc. and BioNTech SE in effectiveness in a large-scale study of five different immunization shots conducted by Hungarian researchers. Moderna’s vaccine was 88.7% effective in protecting against coronavirus infection and 93.6% effective against Covid-related mortality, compared with 85.7% and 95.4%, respectively for Sputnik, according to the paper published Wednesday on the website of the Clinical Microbiology and Infection medical journal. Pfizer came in third with 83.3% and 90.6%, respectively. The research reviewed the effectiveness of five vaccines in people at least seven days after they received their second dose. Data from more than 3.7 million vaccinated people aged 16 and over were reviewed from January to June of this year.
26th Nov 2021 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Nov 2021

View this newsletter in full

South African scientists detect new virus variant amid spike

A new coronavirus variant has been detected in South Africa that scientists say is a concern because of its high number of mutations and rapid spread among young people in Gauteng, the country's most populous province, Health Minister Joe Phaahla announced Thursday. The coronavirus evolves as it spreads and many new variants, including those with worrying mutations, often just die out. Scientists monitor for possible changes that could be more transmissible or deadly, but sorting out whether new variants will have a public health impact can take time.
26th Nov 2021 - Associated Press on MSN.com

New 'Botswana' variant is most mutated version of Covid

Africa Health Body Investigates New Covid Variant in South Africa

African health authorities plan to hold talks with their South African counterparts next week about a new coronavirus variant that has been found in the country. Data on the new variant is currently being analyzed and more information will be released after the meeting, Africa Centres for Disease Control and Prevention Director John Nkengasong said in a virtual briefing on Thursday. A new Covid-19 variant with a large number of mutations has emerged, with cases reported in Botswana, South Africa and Hong Kong, the Independent reported earlier. The B.1.1529, or so-called Botswana variant, is an offshoot of another variant called B.1.1., the London-based newspaper said.
25th Nov 2021 - Bloomberg

Novavax expected to be become fourth Covid vaccine available in UK

Pfizer, AstraZeneca, Moderna. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about two others. One is the vaccine developed by Janssen, approved in May, with doses due to be delivered by the end of this year, but the UK government is now planning to donate all 20m of them to developing countries, via the Covax initiative. The other is the Novavax jab; the government has ordered 60m doses and hundreds of British jobs depend on it. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks.
25th Nov 2021 - The Guardian

COVID-19: New coronavirus variant B.1.1.529 identified in Botswana as scientists play down concerns

A new variant of the coronavirus with a "constellation" of mutations has been identified in Botswana. Designated as B.1.1.529, scientists are still unclear whether existing antibodies would react well to the variant - which has 32 spike protein mutations. Tom Peacock, a virologist at Imperial College London, branded the mutations "really awful". Spike proteins are what viruses use to get into human cells, and some of the vaccines work by training the body to recognise the spikes and neutralise them. Mutations on the spike can therefore potentially prove problematic for mRNA doses, like Pfizer and Moderna. However, with only a handful of recorded cases - three in Botswana, six in South Africa and one in Hong Kong from someone who travelled from South Africa - scientists are hopeful that COVID cases caused by the new virus specimen will not be widespread.
25th Nov 2021 - Sky News

Australia will face a new wave of Covid-19 unless booster shot rates skyrocket, expert warns

Australia will face a new wave of COVID-19 cases similar to that currently being seen in Europe unless booster shot rates dramatically increase, a leading epidemiologist has warned. It comes as several European nations have reimposed restrictions and lockdowns after a spike in infections as the continent heads into winter. While case numbers were reducing in Australia as vaccination levels increase, infectious diseases expert Professor Raina MacIntyre said the country should heed the COVID situation overseas to avoid an identical situation next year.
25th Nov 2021 - Daily Mail

Reinfection from Covid-19 is rare, severe disease is even rarer, a study of people in Qatar finds

When people got reinfected with Covid-19, their odds of ending up in the hospital or dying were 90% lower than an initial Covid-19 infection, according to a new study. The study published Wednesday in the New England Journal of Medicine found that there were few confirmed reinfections among 353,326 people who got Covid-19 in Qatar, and the re-infections were rare and generally mild.
25th Nov 2021 - CNN

Pfizer sues departing employee it says stole COVID-19 vaccine secrets

Pfizer Inc has sued a longtime employee for allegedly stealing "scores" of confidential documents, including some related to its COVID-19 vaccine, as she prepared to jump to a competitor. In a complaint filed on Tuesday in San Diego federal court, Pfizer said Chun Xiao Li breached her confidentiality agreement by uploading more than 12,000 files without permission to her personal accounts and devices from her company-issued laptop. The alleged materials include a Sept. 24 "playbook" containing internal assessments and recommendations about the Pfizer/BioNTech COVID-19 vaccine, Pfizer's relationship with its German vaccine partner, and presentations related to cancer antibodies.
25th Nov 2021 - Reuters

Turkey's domestic COVID-19 vaccine applies for emergency authorisation

Turkey's domestically developed COVID-19 vaccine, Turkovac, has applied for emergency authorisation, Health Minister Fahrettin Koca said on Thursday, adding he hoped the shot would be available for use by year-end. Speaking at his ministry's budget debate in parliament, Koca said work on Turkovac was nearing completion, and added the shot would mark the first Phase III clinical research project to be fully carried out by Turkey. "I would like to share a piece of good news for our people: our domestic inactive COVID-19 vaccine Turkovac has applied for emergency authorisation as of today," Koca said.
25th Nov 2021 - Reuters

S.Africa detects new COVID-19 variant, implications not yet clear

South African scientists have detected a new COVID-19 variant in small numbers and are working to understand its potential implications, they said on Thursday. The variant - called B.1.1.529 - has a "very unusual constellation" of mutations, which are concerning because they could help it evade the body's immune response and make it more transmissible, scientists told reporters at a news conference. Early signs from diagnostic laboratories suggest the variant has rapidly increased in the most populated province of Gauteng and may already be present in the country's other eight provinces, they said.
25th Nov 2021 - Reuters

EU regulator gives go-ahead to first COVID shot for 5-11 year olds

The EU's drug regulator approved the use of Pfizer-BioNTech's COVID-19 vaccine for children between the ages of five and 11 on Thursday, paving the way for them to be given a first shot as Europe struggles with a surge in cases. The European Medicines Agency (EMA) recommended that Pfizer-BioNTech's vaccine, approved for European Union use in teenagers between 12 and 17 years old since May, be given as an injection in the upper arm in two 10 microgram doses, three weeks apart. Adult doses contain 30 micrograms.
25th Nov 2021 - Reuters

Did AstraZeneca Keep Britain Safer From Covid Than Europe?

Pascal Soriot knows how to make a headline. The AstraZeneca Plc chief executive officer gave a rare interview to the BBC to mark the opening of a billion-pound ($1.3 billion) research facility in Cambridge. But he couldn’t resist a little plug for his vaccine, too. “If you look at the U.K., there was a big peak of infections but not so many hospitalizations relative to Europe,” he said. His suggestion — made in dulcet tones and bracketed with the caveat that more research needs to be done — is that the AstraZeneca vaccine offers more longer-term effectiveness against serious illness than rival jabs produced by Pfizer Inc. and Moderna Inc. In other words, Britain’s homegrown jab is the reason the country is faring better with the latest Covid wave than Europe.
25th Nov 2021 - Bloomberg

UK raises alarm over new COVID variant which could beat vaccines

Britain on Thursday said it was concerned by a newly identified coronavirus variant spreading in South Africa that might make vaccines less effective and imperil progress made across the world in fighting the pandemic. The UK Health Security Agency said that the variant - called B.1.1.529 - has a spike protein that was dramatically different to the one in the original coronavirus that COVID-19 vaccines are based on. Officials characterise the variant, which has double the number of mutations as the currently dominant Delta variant, as the "worst one yet".
25th Nov 2021 - Reuters

Pfizer says former employee stole trade secrets on megablockbuster COVID-19 vaccine

Pfizer and other drugmakers go to great lengths to protect their proprietary information. When it comes to the world's best-selling pharmaceutical product, the company's BioNTech-partnered COVID-19 vaccine, Pfizer's defense of trade secrets carries even more weight. That's why the company is working to get a handle on information allegedly stolen by a "soon-to-be former employee." In a new lawsuit filed in California, published by Bloomberg, Pfizer says an employee, Chun Xaio Li, uploaded more than 12,000 files, including "confidential Pfizer documents," to a personal Google Drive account and to personal devices. The company says it "has yet to understand the full scope" of the alleged theft thanks to the "sheer number" of documents involved. The company's lawsuit focuses on the COVID-19 vaccine, Comirnaty, and two cancer monoclonal antibodies.
24th Nov 2021 - FiercePharma

Emotional toll of COVID-19 on health workers is vast, varied

In the US study, a team led by Duke University researchers surveyed 1,344 HCWs in 2020 about their emotional state before the availability of COVID-19 vaccines. They recruited HCWs via email and social media from Apr 24 to May 30 (phase 1) and Oct 24 to Nov 30 (phase 2). In phase 1 involved 335 survey respondents of whom 32.6% were 35 to 44 years old, 86% were women, and 87.8% were White. Phase 2 included 1,009 participants, of whom 38.1% were aged 35 to 44, 90.5% were women, and 93.7% were White. Respondents included nurses, physicians, advanced practice practitioners, and chaplains. The HCWs reported emotions related to changes in family, social life, and occupational function. They expressed fear of contracting COVID-19 and spreading the infection to family and friends, stigmatization, short-staffing, and inadequate personal protective equipment (PPE).
24th Nov 2021 - CIDRAP

Virus expert Trevor Bedford on annual Covid boosters and the inevitable next pandemic

In January 2020, computational biologist Trevor Bedford told STAT’s Helen Branswell about the then-new coronavirus: “If it’s not contained shortly, I think we are looking at a pandemic.” Talk about a prediction. Last week at the 2021 STAT Summit, Branswell again caught up with Bedford, a scientist at the Fred Hutchinson Cancer Research Center and an expert on viral evolution and epidemiology. They talked about the future of the coronavirus and antigenic drift (essentially, whether the virus mutates in ways that escape the protection generated by vaccines or earlier infections), as well as what’s in store for flu season, and what might lie ahead with the next pandemic.
24th Nov 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Nov 2021

View this newsletter in full

Ecuador to administer COVID-19 booster shots to general population in 2022

Ecuador will administer booster shots against COVID-19 to the general population starting January 2022, the government said on Wednesday, acknowledging a rise in cases in the Amazon region due to difficulties in carrying out vaccinations.
25th Nov 2021 - Reuters

Novavax expected to be approved as fourth Covid vaccine in UK

Pfizer, AstraZeneca, Moderna. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about another jab, Novavax – even though the government has ordered 60m doses and hundreds of British jobs depend on it. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks. It will bring to an end what feels like a long wait compared with the speedy development and approval of the other jabs, including for those who took part in trials.
24th Nov 2021 - The Guardian

Canada gives full approval to J&J's single-shot COVID-19 vaccine

Johnson & Johnson said Canada gave full approval to its single-shot COVID-19 vaccine for people aged 18 years and older, making it the first full approval for the vaccine globally. The vaccine was previously authorised by the country under an interim order. Canada, which is reporting 2,563 infections on average each day and has administered at least 60,101,058 doses of COVID-19 vaccines so far, gave full approval to Moderna Inc and Pfizer Inc's coronavirus vaccines in September. The country authorised the use of Pfizer's COVID-19 vaccine for children aged 5 to 11 and a booster dose for people aged 18 years and older this month
24th Nov 2021 - Reuters

Russia's Putin took part in trials of nasal form of COVID vaccine

Russian President Vladimir Putin has been revaccinated against COVID-19, Russian news agencies quoted him as saying on Sunday. Putin said in June 2021 that he had been vaccinated with Sputnik V vaccine. "Today, on your recommendation and that of your colleagues, I got another vaccination, Sputnik Light. This is called revaccination," Putin said at a meeting with the deputy director of the Gamaleya Research Centre for Epidemiology and Microbiology, which developed both vaccines.
24th Nov 2021 - Reuters

UK PM Johnson: disappointing that Valneva COVID-19 shot did not gain approval

British Prime Minister Boris Johnson said on Wednesday he was disappointed that Valneva's COVID-19 vaccine had not gained approval in Britain, two months after the government cancelled a supply deal worth 1.4 billion euro ($1.57 billion) for the shot. Health minister Sajid Javid had said commercial considerations played into the decision, but added it was clear Valneva's shot would not be approved in Britain. His statement was later corrected to say that the shot had not gained approval and may not gain it. Valneva said in a statement it hoped for approval by the end of the year and was working with the Medicines and Healthcare products Regulatory Agency (MHRA), the independent medicines regulator.
24th Nov 2021 - Reuters

South Korea's Enzychem to make Indian drugmaker Cadila's COVID-19 shot

South Korea's Enzychem Lifesciences would make at least 80 million doses of India's homegrown DNA COVID-19 vaccine from Cadila Healthcare, the Indian drugmaker said on Wednesday. As part of the deal, Cadila will transfer the DNA vaccine technology to Enzychem, which will make and sell the vaccine, ZyCoV-D, within its territory under the Cadila trademark. Cadila will get license fees and royalty payments, the company said in a filing to stock exchanges.
24th Nov 2021 - Reuters

Bharat's COVID-19 shot 50% effective at height of India infections - small study

Bharat Biotech's vaccine was only 50% effective at preventing symptomatic COVID-19 in a high-risk population during a devastating second wave of infections in India this year, data gleaned from hospital workers showed. The real world study for Covaxin, conducted April 15-May 15, compares with a 77.8% effectiveness rate in a late-stage trial of more than 25,000 participants that was conducted November 2020 to January 2021. The new data analysed just over 1,000 COVID-19 cases with a test-negative control case group, matching by age and gender, according to the study which was published in the Lancet Infectious Diseases journal.
24th Nov 2021 - Reuters

China's Homegrown Virus Pill Could Offer a Pivot From Covid Zero

Where will newly developed Covid pills be needed the most? Rather than pandemic hot spots, it’ll be a place where the virus has yet to gain a sustained foothold: China. That’s the take from Tong Youzhi, chief executive officer at Kintor Pharmaceutical Ltd., a Chinese company working on just such a product. After successfully containing the virus with mass testing, surveillance and rigid border curbs, China is now uniquely vulnerable to the novel pathogen and needs access to effective treatments if outbreaks worsen. “China is a virgin land for the virus, with so few people exposed,” Tong said in an interview with Bloomberg News. “The urgency for effective Covid drugs is no less in China than elsewhere if we want to regain our pre-pandemic life.”
24th Nov 2021 - Bloomberg

African company works to replicate Moderna's COVID vaccine, without permission, to address unequal access

There are huge gaps in the availability of COVID-19 vaccines between different countries. Just 10% of people in Africa have received a single dose, compared to 63% across North America or 62% in Europe. CBS News correspondent Debora Patta found a start-up in South Africa that hopes to redress that imbalance by reverse engineering one of the major U.S.-made vaccines, making it easier to store, and then producing it independently. A pair of nondescript warehouses in a dusty part of Cape Town is the unlikely home of a medical revolution. Inside the airlocked, sterile rooms, Patta found a band of rebels in white lab coats who are passionate about using science to change the world.
24th Nov 2021 - CBS News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Nov 2021

View this newsletter in full

Mexico eyes COVID-19 vaccine booster shots, especially for older adults

Mexico will analyze administering booster vaccine doses against COVID-19, especially for older people, President Andres Manuel Lopez Obrador said on Tuesday, softening his previous stance on the need for a third shot. Less than two months ago, Lopez Obrador had rejected suggestions that Mexico should administer a third vaccine shot, saying experts deemed it to be unnecessary. But his government has gradually opened the door to giving more people shots, including teenagers.
23rd Nov 2021 - Reuters

Covaxin Gave Lower Protection Amid India's Deadly Delta-Led Wave

Covaxin, one of the main vaccines used in India’s coronavirus immunization drive, provides only 50% protection against symptomatic Covid-19, according to a real-world study that suggests the shot is less effective than initially thought. As India was slammed by its second-major Covid wave earlier this year, researchers at the All India Institute of Medical Sciences in Delhi analyzed data from 2,714 of the hospital’s health workers who were showing signs of infection and underwent RT-PCR testing between April 15 and May 15, according to a study published in The Lancet Infectious Diseases journal. At the start of the country’s vaccination campaign in January, staff at AIIMS had exclusively been offered Covaxin, a shot co-developed by India’s state-funded health research agency and Bharat Biotech International Ltd.
23rd Nov 2021 - Bloomberg

Biden Covid Vaccine Booster Plan May Face Resistance From CDC Panel, FDA

Medical experts who advise U.S. regulators on vaccines are chafing at what they perceive as political interference in the review process by the Biden administration. Last month, the White House announced plans to begin distributing Covid-19 booster shots to Americans Sept. 20. However, the effort still needs the Food and Drug Administration and the Centers for Disease Control and Prevention to sign off. Members of a key panel that advises the CDC on vaccines have pushed back consideration of the plan to mid-September and said this week they were concerned that politics was getting ahead of the process. It’s “very frightening to me that health-care providers are trying to do the best job that they can, and are taking guidance from HHS and the White House,” said Helen Talbot, a Vanderbilt University professor of medicine and member of the CDC’s Advisory Committee on Immunization Practices, in a meeting Monday.
23rd Nov 2021 - Bloomberg

The real risk of heart inflammation to kids is from COVID-19—not the vaccine

Elizabeth Brown, a mother of two who lives outside Denver, Colorado, had a tough decision to make when childhood COVID-19 vaccines became available. Her five-year-old was born with a congenital heart defect that required a risky surgery when he was two years old to avoid a lifelong risk of heart inflammation from infection. But Brown also knew that after getting some COVID-19 vaccines, adolescent boys are at risk of developing myocarditis, a different kind of inflammation of the heart. ”To read about children with no cardiac history having myocarditis as a pediatric vaccine complication was scary,” Brown says. “There were a lot of inflammatory headlines from the media that preyed on a parent’s fear in terms of the vaccination and very little information readily available regarding the damage COVID can do.”
23rd Nov 2021 - National Geographic

AstraZeneca chief: Our coronavirus vaccine could protect older people longer than mRNA jabs

The head of AstraZeneca has suggested that the company’s adenovirus vaccine could provide longer-lasting protection against COVID-19 especially in older people than the mRNA vaccines from BioNTech/Pfizer and Moderna. French CEO Pascal Soriot said this could be a reason why the U.K. hasn’t experienced the same high levels of hospitalizations as Europe, where cases have surged in recent months. But he said more data was needed. “It's really interesting, when you look at the U.K., there was a big peak of infections, but not so many hospitalizations relative to Europe,” he told BBC Radio 4. “In the U.K., this vaccine was used to vaccinate older people whereas in Europe initially people thought the vaccine doesn't work in older people,” he said. The pharma chief suggested that this could be because AstraZeneca’s adenovirus vaccine provides a better T cell response than mRNA vaccines. “The antibody response is what drives the immediate reaction or defense of the body when you are attacked by the virus,” Soriot said. “And the T cell response takes a little longer to come in. But it's actually more durable; it lasts longer.” The pharma chief said AstraZeneca’s adenovirus COVID-19 vaccine “has been shown to stimulate T cells to a higher degree in older people.”
23rd Nov 2021 - POLITICO.eu

The FDA will soon decide on Merck's Covid-19 antiviral pill. It shows promise, but there are also concerns

In the fall of 2015, Dr. Mark Denison was preparing for a long drive home from Alabama after making a presentation at a scientific meeting when a colleague asked him to stick around for lunch and check out some data on a potential new drug. Denison said yes, and six years later, he's very glad he stayed. Denison's colleague, George Painter, is a "drug hunter" at Emory University in Atlanta. At lunch, he showed Denison lab results he'd obtained with a new antiviral compound, now known as molnupiravir. "It just knocked my socks off," said Denison, an infectious disease specialist at Vanderbilt University Medical Center. "With increasing concentrations of the drug, the virus's ability to grow just plummeted." Painter's lab looked at the effect molnupiravir had against the influenza virus and chikungunya, a virus that's spread by mosquitos. After the Alabama meeting, Painter sent some of the compound to Denison, who tried it in his lab against the virus that causes Middle East Respiratory Syndrome.
23rd Nov 2021 - CNN

Pfizer says its Covid vaccine is STILL 100% effective in children ages 12 to 15 four months after the second dose

Pfizer-BioNTech released data on Monday from a long-term analysis of their COVID-19 vaccine in kids aged 12 to 15. There were 30 confirmed symptomatic Covid cases in the placebo group compared to none in the vaccinated group Researchers say this equates to 100% efficacy at least four months after receiving the second dose. The vaccine is currently only fully approved for those aged 16 and older but the companies plan to apply for extended approval in the 12-15 age group soon
23rd Nov 2021 - Daily Mail

Vaccines Ward Off Severe Covid in U.S., Wane Against Infections

Covid-19 vaccines remain highly effective at keeping people alive and out of the hospital, but new U.S. data add further support to the argument that the shots aren’t preventing infections as much as they once did. Unvaccinated people were about five times more likely to test positive for the virus than the vaccinated in the week starting Sept. 26, down from about 15 times more likely in May, according to the latest age-adjusted data from the Centers for Disease Control and Prevention, which were updated Monday. The new figures come shortly after the CDC approved booster shots for all adults, and could provide additional support for third doses as the U.S. heads into its traditional winter virus season. Covid-19 cases are rising across many parts of the U.S., including the Midwest and Northeast. The CDC data isn’t adjusted for time since vaccination. That means that the earliest recipients of the vaccine -- mostly senior citizens and those with pre-existing conditions -- are possibly at even greater risk.
23rd Nov 2021 - Bloomberg

Covid antivirals could be pandemic game-changers. But Americans might struggle to access them

Antiviral drugs for treating Covid-19 have been hailed as a pandemic “game-changer” — a tool that could, perhaps, finally help life return to normal. But basic gaps in the U.S. health system could mean that two new treatments from Pfizer and Merck won’t make much of a difference after all. The companies’ treatments, which haven’t yet received emergency authorization, could make a Covid diagnosis dramatically less threatening. But in practice, before receiving the pills, patients may need to jump through a series of hoops that often prevent Americans from accessing care: Recognizing their symptoms, taking a test, getting a prescription from a clinician, and filling the prescription at a pharmacy. “Our routine medical systems are not really set up for this,” said Céline Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration. “These are medications that need to be started within three days of developing symptoms. It can take you longer than three days to get an appointment.”
23rd Nov 2021 - STAT News

COVID-19 tied to higher risk of stillbirth, maternal death

In the first study, the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team analyzed data from the Premier Healthcare Database Special COVID-19 Release, a large, hospital-based database from March 2020 to September 2021, a period that included the emergence and eventual dominance of Delta. Of all pregnant women in the database, 53.7% were White, 50.6% had private health insurance, 15.4% were obese, 11.2% had diabetes, 17.2% had high blood pressure, 1.8% had multiple-gestation pregnancy, 4.9% smoked, and 1.73% had COVID-19. The study authors noted that most of the women who tested positive for COVID-19 at delivery were likely unvaccinated. Among 1,249,634 deliveries at 736 hospitals, stillbirths were rare, at 0.65%, but the rate was 1.26% among 21,653 deliveries to pregnant COVID-19 patients, compared with 0.64% among 1,227,981 deliveries to non–COVID-19 patients. Stillbirths were defined as fetal deaths at 20 weeks' gestation or later.
22nd Nov 2021 - CIDRAP

Pfizer, BioNTech ace long-term test of their COVID vaccine in kids 12 to 15, setting up likely approval

Six months ago, Pfizer and BioNTech secured emergency use authorization for their COVID-19 vaccine in 12- to 15-year-olds. Now, the companies have provided long-term data that could bring a full approval in the age group. In a follow-up study of 2,228 children, the vaccine was 100% effective in preventing infection seven days to four months after the second dose. There were no serious safety concerns observed in those with at least six months of follow-up. With the results, the companies will file for full FDA approval in the age group. In August, the shot won an FDA nod in people 16 and older.
22nd Nov 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Nov 2021

View this newsletter in full

‘Herd immunity’ more complex than reaching 70% vaccine rate, says Oregon health expert

With COVID cases declining and the vaccine rate reaching 73%, many Oregonians are wondering when they can drop their face masks. Health experts say: not until early next year, if not longer. The COVID-19 booster is now available to all adults in Oregon. The Oregon Health Authority made the announcement Saturday, a day after the Centers for Disease Control and Prevention announced similar federal guidelines. The news comes after a weeks-long decline in COVID cases across the state. Case numbers are about half what they were at the peak of the Delta surge in September, and COVID-related hospitalizations are down to about 400 patients. By contrast, there were 1,178 COVID patients in Oregon on Sept. 1. Nonetheless, state health officials say there’s still a long road ahead.
22nd Nov 2021 - OPB News

Pfizer's Covid vaccine was 100% effective in kids in longer-term study

Pfizer and BioNTech announced Monday that their Covid-19 vaccine was 100% efficacious in preventing infections in 12- to 15-year-olds, measured from seven days to four months after administration of the second dose of the vaccine. The companies said the new data — a longer-term analysis of a Phase 3 trial conducted in 2,228 participants — will form the basis of an application to the Food and Drug Administration for an extension of their Covid-19 vaccine license to cover youths in the age group.
22nd Nov 2021 - STAT

EU considers booster doses of J&J's COVID-19 vaccine

The European Medicines Agency says it is evaluating whether to authorize booster doses of Johnson & Johnson's single-shot COVID-19 vaccine. In a statement Monday, the EU drug regulator said it was considering an application from J&J to recommend booster doses of the J&J vaccine for adults 18 and over, at least two months after they were first immunized. Amid an explosive surge of new coronavirus infections across Europe the EMA said it expected to make a decision on this within weeks. The U.S. Food and Drug Administration gave the green light to J&J booster doses in October, both for people who initially received the J&J and vaccine and for people who got immunized with other vaccines.
22nd Nov 2021 - The Independent

Covid-19: UK will avoid European Delta surge due to vaccines and growing immunity, experts say

Coronavirus vaccinations may have prevented about 300,000 deaths in the UK, a leading scientist has claimed. Professor Sir Andrew Pollard, who helped create the Oxford/AstraZeneca vaccine, has hailed the success of the UK’s vaccination programme. He told the BBC’s Andrew Marr: “If we just look at the UK, the predictions last year were that there would be between 300,000 and 500,000 deaths. “And actually when you look at the data on lives saved so far this year, we’re actually not far off to actually think that that is the right number, that we might have been at around about 300,000 deaths by now without a vaccine.” He also said immunity is building in younger age groups due to high infection levels seen since the end of summer.
22nd Nov 2021 - iNews

Revealed: Over 600 babies born premature and needing critical care to mothers hospitalised by Covid-19

More than 600 babies have been born prematurely and needing critical care to mothers hospitalised by Covid-19, The Independent can reveal — as women are warned they are up to three times more likely to have an early birth with the virus. The figures, which cover 17 months of the pandemic, prompted calls for the government to make pregnant women of all ages eligible for Covid-19 booster jabs. Concern about pregnant women avoiding the vaccine has pushed chief medical officer Chris Whitty to urge mothers-to-be to get fully jabbed, with take-up rates in this group as low as 15 per cent last month.
22nd Nov 2021 - The Independent

Baidu in partnership with Sanofi to use its algorithm in mRNA vaccine, therapy development

Chinese tech giant Baidu Inc said on Monday it has licensed its algorithm for messenger RNA (mRNA) sequence to Sanofi SA for use in designing vaccine and therapeutic products, entering its first such commercial deal with a major global drugmaker. Sanofi had been one of the world's biggest vaccine makers before the pandemic, but the French firm was beaten by rivals BioNTech /Pfizer) and Moderna in developing mRNA shots against COVID-19. read more Sanofi stopped trials of its own mRNA COVID-19 shot in September, and is instead focusing on efforts with GlaxoSmithKline to bring another COVID-19 vaccine candidate to market based on the more conventional protein-based approach.
22nd Nov 2021 - Reuters

Germany promotes 'Rolls-Royce' Moderna shot to meet demand for COVID boosters

Germany will promote Moderna for Germans seeking booster shots as high demand for the BioNTech/Pfizer vaccine risks depleting stocks and derailing efforts to tame a fourth wave of the pandemic, Health Minister Jens Spahn said on Monday. Spahn warned during a news conference that some 16 million Moderna doses could expire in the first quarter of next year if unused, adding that some experts see Moderna as the "Rolls-Royce" of vaccines with BioNTech the "Mercedes". "Unfortunately the impression is we will insist on Moderna only to avoid the expiry of those vaccines in the first quarter of 2022," said Spahn.
22nd Nov 2021 - Reuters

Pfizer's COVID-19 vaccine trial data shows long-term efficacy in adolescents

Pfizer Inc said on Monday its COVID-19 vaccine provided strong long-term protection against the virus in a late-stage study conducted among adolescents aged 12 to 15 years. A two-dose series of the vaccine was 100% effective against COVID-19, measured seven days through over four months after the second dose, the company said. The long-term data will support planned submissions for full-regulatory approval of the vaccine in the age group in the United States and worldwide.
22nd Nov 2021 - Reuters

EU says decision on J&J COVID-19 vaccine booster dose 'within weeks'

The European Union's drug regulator said on Monday it was evaluating data on booster doses of the COVID-19 vaccine by Johnson & Johnson (JNJ.N) following an application, and a decision could come "within weeks" under a speedy review. The approval sought is for use of a booster dose of the single-shot vaccine, COVID-19 Vaccine Janssen, to be given at least two months after the first dose to people aged 18 years and older, the European Medicines Agency (EMA) said.
22nd Nov 2021 - Reuters

How COVID shots for kids help prevent dangerous new variants

Cadell Walker rushed to get her 9-year-old daughter Solome vaccinated against COVID-19 — not just to protect her but to help stop the coronavirus from spreading and spawning even more dangerous variants. “Love thy neighbor is something that we really do believe, and we want to be good community members and want to model that thinking for our daughter,” said the 40-year-old Louisville mom, who recently took Solome to a local middle school for her shot. “The only way to really beat COVID is for all of us collectively to work together for the greater good.” Scientists agree. Each infection — whether in an adult in Yemen or a kid in Kentucky — gives the virus another opportunity to mutate. Protecting a new, large chunk of the population anywhere in the world limits those opportunities.
22nd Nov 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Nov 2021

View this newsletter in full

Pfizer to apply for EU authorization of its COVID pill on Friday

Pfizer plans to apply for a European authorisation of its experimental antiviral pill to treat COVID-19 on Friday, German weekly Wirtschaftswoche said, citing sources close to the European Medicines Agency (EMA) and the company. The paper also said that acting German health minister Jens Spahn plans to buy Pfizer's medicine. "The health ministry is in contact with Pfizer regarding a possible procurement of the antiviral drug Paxlovid," Wirtschaftswoche quoted a ministry's spokesperson as saying.
20th Nov 2021 - Reuters

China's BioKangtai begins first shipment of AstraZeneca's COVID-19 shot

AstraZeneca Plc's (AZN.L) COVID-19 vaccine partner in China, Shenzhen Kangtai Biological Products (BioKangtai) (300601.SZ), has begun its first shipment of the shot, sending more than four million doses to Indonesia, BioKangtai said on Friday. Including the first batch, BioKangtai plans to send over eight million doses of the China-made AstraZeneca shot, branded as KconecaVac, to Indonesia this month, Zhang Qian, general manager at BioKangtai's international affairs department, said in a video interview with local media.
20th Nov 2021 - Reuters

Market in China's Wuhan likely origin of COVID-19 outbreak - scientist

The first known COVID-19 case was a market vendor in the Chinese city of Wuhan, not an accountant who appeared to have no link to the market but whose case contributed to speculation the virus could have leaked from a lab, a U.S. researcher wrote in a commentary piece published on Thursday. The origin of the SARS-CoV-2 virus that causes COVID-19 remains a mystery and a major source of tension between China and the United States. The new analysis by the researcher does not provide a definitive answer to that question.
20th Nov 2021 - Reuters

Canada authorizes Pfizer Covid vaccine for ages 5-11

Canada on Friday became the latest country to authorize the Pfizer-BioNTech Covid-19 vaccine for children aged between five and 11-years-old. "After a thorough and independent scientific review of the evidence, the department has determined that the benefits of this vaccine for children between five and 11 years of age outweigh the risks," said an official statement from Health Canada. The decision follows an application by the companies submitted on October 18 after carrying out a clinical trial among thousands of children in this age group. The vaccine was found to be more than 90 percent effective at preventing Covid-19, and no serious side-effects were identified. It is dosed at 10 micrograms rather than the 30 micrograms used in older ages, and administered as two shots, three weeks apart.
20th Nov 2021 - FRANCE 24

Merck Covid pill backed for EU emergency use

The EU's drug watchdog on Friday backed Merck's anti-Covid pill for emergency use ahead of its formal authorisation and started reviewing Pfizer's antiviral treatment as cases soar across Europe. The two pills by the US pharma giants represent a potentially groundbreaking step in the fight against coronavirus as studies show they cut the risk of hospitalisation and death in high-risk patients. The European Medicines Agency (EMA) said that while the Merck pill was not yet approved, it had "issued advice" so that individual countries in the 27-nation EU could decide whether to use it in case of a surge in infections. "The medicine, which is currently not authorised in the EU, can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe Covid-19," the EMA said in a statement. "EMA issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorisation, for example in emergency use settings, in light of rising rates of infection and deaths due to Covid-19 across the EU."
20th Nov 2021 - RFI

CDC expands COVID booster jab eligibility to all US adults

The US Centers for Disease Control and Prevention (CDC) has expanded eligibility for COVID-19 booster jabs to all adults in the United States, move that paves the way for millions more Americans to receive additional protection against the virus. The CDC on Friday evening endorsed the advice of a health advisory panel, which earlier voted unanimously to recommend expanding booster eligibility to all Americans aged 18 and older who received their second dose of the Pfizer-BioNTech or Moderna vaccines at least six months earlier.
20th Nov 2021 - Aljazeera.com

Canada approves Pfizer-BioNTech jab for kids starting at age five

The vaccine is 90.7 percent effective at preventing COVID-19 in kids with no serious side effects, Health Canada said. Canada has approved the Pfizer-BioNTech coronavirus vaccine for children between the ages of five and 11. It’s the first jab to be approved for kids in that age group, Health Canada said on Friday, calling the move “a major milestone” in the fight against COVID-19. The vaccine was 90.7 percent effective at preventing COVID-19 in children five to 11 years of age, Health Canada said, and no serious side effects were identified. “After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks,” Health Canada said in a statement. Kids in Canada will receive two doses of the vaccine, at 10 micrograms each, to be taken three weeks apart. That is a lower dose than the 30 micrograms two-dose regimen authorised for people 12 years of age and older.
20th Nov 2021 - Aljazeera.com

Could this gene double your risk of dying from COVID-19?

Soon after the pandemic began, we knew that certain groups of people are more at risk of dying from COVID-19 than others. It was immediately clear that those with specific underlying health conditions such as diabetes and cardiovascular disease were at increased risk, but slowly it became evident that certain ethnic groups were also being disproportionately affected. Social factors have played an important role in why these groups have been more affected than others, but genetics may also play a part. Scientists at Oxford University have now identified a version of a gene that may be associated with doubling the risk of respiratory failure from COVID, and it could go some way to explaining why people from particular backgrounds are more likely to die from the virus. The study’s authors said that their work identifying the gene was extremely difficult because it wasn’t merely the presence of the gene they were looking for, but whether it was switched “on”, making it more high risk.
20th Nov 2021 - Al Jazeera English

How will the COVID pandemic affect flu season?

Countries in the Northern Hemisphere are facing an unpredictable winter as COVID-19 continues to spread during the flu season, experts have warned. Last year, when governments recommended a range of protective measures such as mask-wearing, social distancing and lockdowns to slow COVID-19 infections, the number of influenza cases dropped dramatically compared with the seasonal average. According to the European Centre for Disease Prevention and Control (ECDC) about 20 percent of the population catches the flu each year, but that figure fell by more than 99 percent in 2020-21. There were no hospitalised cases nor fatalities reported from influenza last season. Cases this year have remained low, according to the World Health Organization (WHO), but with COVID restrictions being lifted in many parts of the world, children back in school, and the coronavirus continuing to spread, experts are urging people to remain cautious. An uptick of influenza cases could burden health systems already facing difficulties due to outbreaks of COVID-19
20th Nov 2021 - Aljazeera.com

FDA official explains decision on 'simplified' booster shots

The U.S. government’s booster campaign got a lot simpler Friday after Food and Drug Administration officials authorized extra shots of Pfizer and Moderna COVID-19 vaccines for all adults. It replaces a complicated system in which eligibility was based on age, health conditions and other factors. “It’s simplified things, I think significantly over the situation that we had in place previously,” FDA’s vaccine chief Dr. Peter Marks told The Associated Press. The FDA action comes after months of debate among experts over whether everyone 18 and older should get an extra shot for protection.
20th Nov 2021 - The Associated Press

Research links COVID-19 in pregnancy with stillbirths

Pregnant women with COVID-19 face increased chances for stillbirths compared with uninfected women, and that risk spiked to four times higher after the delta variant emerged, new government data show. The federal Centers for Disease Control and Prevention released a report Friday that examined 1.2 million deliveries in 736 hospitals nationwide from March 2020 through September 2021. Stillbirths were rare overall, totaling 8,154 among all deliveries. But the researchers found that for women with COVID-19, about 1 in 80 deliveries resulted in stillbirth. Among the uninfected, it was 1 in 155. Among those with COVID-19, stillbirths were more common in people with chronic high blood pressure and other complications, including those in intensive care or on breathing machines.
20th Nov 2021 - The Associated Press

US opens COVID boosters to all adults, urges them for 50+

The U.S. on Friday opened COVID-19 booster shots to all adults and took the extra step of urging people 50 and older to seek one, aiming to ward off a winter surge as coronavirus cases rise even before millions of Americans travel for the holidays. Until now, Americans faced a confusing list of who was eligible for a booster that varied by age, their health and which kind of vaccine they got first. The Food and Drug Administration authorized changes to Pfizer and Moderna boosters to make it easier. Under the new rules, anyone 18 or older can choose either a Pfizer or Moderna booster six months after their last dose. For anyone who got the single-dose Johnson & Johnson vaccine, the wait already was just two months. And people can mix-and-match boosters from any company.
20th Nov 2021 - The Associated Press

Fauci overwhelmed by calls after journal published mistake over beagle experiments | TheHill

The nation's top infectious disease expert Anthony Fauci has been inundated with calls following a mistake in a scientific journal claiming that the National Institute of Allergy and Infectious Diseases (NIAID) was funding experimental research on beagles. The calls were so frequent that Fauci's assistant stopped answering the phone for two weeks in October, The Washington Post reported Friday. He received 3,600 phone calls in 36 hours. “The constant harassment in the form of ridiculous accusations and outright lies makes doing my job and that of my staff of fighting the covid-19 pandemic all the more difficult,” Fauci told the Post. “This attack on me, which clearly has political overtones to a nonpolitical scientist, I feel, is dangerous to the entire field of science and [shows] how people try to intimidate scientists.”
20th Nov 2021 - The Hill

Pfizer-BioNTech, Moderna Covid-19 Boosters for All Adults Backed by FDA, CDC

Booster shots from Pfizer Inc and partner BioNTech and Moderna Inc. MRNA will be available to all adults after the Centers for Disease Control and Prevention endorsed the extra doses for people at least six months after their second shot. The signoff Friday by CDC Director Rochelle Walensky will lead to a significant widening of the U.S. booster campaign that health officials hope will remove confusion and offer people more protection ahead of holiday gatherings and travel as new daily Covid-19 cases are beginning to rise again. “Booster shots have demonstrated the ability to safely increase people’s protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays,” Dr. Walensky said.
20th Nov 2021 - The Wall Street Journal

Merck’s Covid Pill Can Be Used to Treat Adults, EU Regulator Says

Merck & Co.’s antiviral pill for Covid-19 can be used to treat adults in the European Union, the bloc’s drug regulator said, giving countries another weapon to use as a fourth wave of the pandemic sweeps the continent. Merck’s Lagevrio pill, known generically as molnupiravir, is still under review and hasn’t been formally authorized for sale. But until then, it can be used to treat adults who don’t need oxygen therapy and face an increased risk of developing severe Covid, the European Medicines Agency’s human medicines committee said on Friday. National authorities may decide to use the pill in emergency settings “in light of rising rates of infection and deaths due to Covid-19 across the EU,” the regulator said. Austria imposed a nationwide lockdown on Friday, and German authorities said they wouldn’t rule out a similar move, as cases rise and intensive care facilities fill up.
20th Nov 2021 - Bloomberg

Delta variant dangerous during pregnancy, CDC reports say

Once the delta variant took hold in the United States, pregnant individuals and their fetuses or babies faced increased risks from coronavirus infections, according to two new reports released Friday by the Centers for Disease Control and Prevention. One report found that 15 pregnant patients died of covid-related causes between March 2020 and early October, including nine who died after delta became the most prominent strain. All but one of the women who died had underlying health conditions, and none had been fully vaccinated. The second report found that the risk of stillbirth increased about fourfold for women with covid-19 as delta surged. The reports’ authors emphasize the importance of preventive measures including vaccination, which the CDC recommends for pregnant people. Only about 30 percent of pregnant Americans are vaccinated, a rate far lower than the population as a whole.
20th Nov 2021 - The Washington Post

Hong Kong Approves Sinovac Vaccine for Children Ages 3-17

Hong Kong approved lowering the age of eligibility for the Covid-19 vaccine from China’s Sinovac Biotech Ltd. to three years old, down from 18 years old. The city’s Secretary for Food and Health said adolescents from 12-to-17 years will be accorded priority to receive the vaccine, “with a view to extending to children of a younger age group at a later stage,” according to a statement on Saturday. Experts serving on panels for the Centre for Health Protection had earlier backed the new age limit. The expansion of the eligible population comes as Hong Kong’s immunization campaign hits a wall. Vaccine hesitancy is ripe especially among the elderly population, many of whom refuse to even get one dose. Since the effort began in February, about 60% of residents have been fully vaccinated, according to Bloomberg’s Vaccine Tracker.
20th Nov 2021 - Bloomberg

EU recommends Merck COVID-19 pill for adults at risk of severe illness

The European Union's drug regulator on Friday advised that an experimental COVID-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening. The European Medicines Agency (EMA) said the pill, developed along with Ridgeback Biotherapeutics, should be taken twice a day for five days, but advised against use during pregnancy for in women who plan to get pregnant.
20th Nov 2021 - Reuters

U.S. expands COVID-19 booster eligibility to all adults

U.S. regulators expanded eligibility for booster shots of COVID-19 vaccines to all adults on Friday, allowing millions more Americans to get additional protection against the virus amid a recent rise in infections. The director of the Centers for Disease Control and Prevention, Rochelle Walensky, signed off on the expanded eligibility on Friday evening after the U.S. Food and Drug Administration broadened its authorization of booster doses to all adults who had received their second shot of either the Pfizer/BioNTech or Moderna Inc vaccine at least six months prior.
20th Nov 2021 - Reuters

Hong Kong Approves Sinovac Vaccine for Children Ages 3-17

The city’s Secretary for Food and Health said adolescents from 12-to-17 years will be accorded priority to receive the vaccine, “with a view to extending to children of a younger age group at a later stage,” according to a statement on Saturday. Experts serving on panels for the Centre for Health Protection had earlier backed the new age limit. The expansion of the eligible population comes as Hong Kong’s immunization campaign hits a wall. Vaccine hesitancy is ripe especially among the elderly population, many of whom refuse to even get one dose. Since the effort began in February, about 60% of residents have been fully vaccinated, according to Bloomberg’s Vaccine Tracker. That compares with over 80% in Singapore, its rival financial hub in Asia.
20th Nov 2021 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Nov 2021

View this newsletter in full

Canada to authorize use of Pfizer's COVID-19 vaccine for children -source

Canada will announce as expected on Friday it is authorizing the use of Pfizer Inc's COVID-19 vaccine for children aged 5 to 11, a government source said on Thursday. The decision will make it the first shot for young children in Canada. Officials had made clear for weeks that the decision would be favorable, noting that incidences of COVID-19 are now highest in those under 12. Prime Minister Justin Trudeau said last month that Ottawa had signed a deal with Pfizer to quickly receive 2.9 million doses of the vaccine once it was approved.
18th Nov 2021 - Reuters

‘Zero-Covid is not going to happen’: experts predict a steep rise in US cases this winter

A steep rise in Covid-19 cases in Europe should serve as a warning that the US could also see significant increases in coronavirus cases this winter, particularly in the nation’s colder regions, scientists say. However, there is more cause for optimism as America enters its second pandemic winter, even in the face of likely rises in cases. Evidence shows vaccine-conferred protection against hospitalization and death remains high several months after inoculation, vaccines for children older than five can reduce Covid transmission, and new antiviral medications hold the promise of making Covid-19 a treatable disease.
18th Nov 2021 - The Guardian

AstraZeneca's antibody drug over 80% effective at preventing Covid, trial shows

The data showed that patients given a single injection of the antibody treatment were 83% less likely to develop symptomatic cases of the coronavirus than participants who were given a placebo. Around 2% of the world’s population is thought to be at risk of not responding well to Covid-19 vaccines, according to AstraZeneca. In a separate trial, patients with mild-to-moderate Covid-19 who were given one dose of AZD7442 within three days of developing symptoms had their risk of developing severe disease reduced by 88%.
18th Nov 2021 - CNBC

Pfizer, U.S. ink $5.29 deal over possible COVID-19 treatment

The U.S. government will pay drugmaker Pfizer $5.29 billion for 10 million treatment courses of its potential COVID-19 treatment if regulators approve it. Pfizer asked the Food and Drug Administration on Tuesday to authorize the experimental pill, which has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The FDA is already reviewing a competing pill from Merck and will hold a public meeting on it later this month. The price for Pfizer’s potential treatment amounts to about $529 per course. The U.S. has already agreed to pay roughly $700 per course of Merck’s drug for about 1.7 million treatments.
18th Nov 2021 - The Independent

Moderna seeks U.S. authorization of COVID-19 booster shots for all adults

Moderna Inc said on Wednesday it had applied with the U.S. Food and Drug Administration for authorization of its COVID-19 booster vaccine for all adults aged 18 and older. The FDA has cleared booster shots of COVID-19 vaccines for people who are immunocompromised, those aged 65 and older and for individuals at high risk of severe disease or who are regularly exposed to the virus. Moderna is seeking authorization for a 50-microgram booster dose, half the strength of its original vaccine given in two shots about four weeks apart.
18th Nov 2021 - Reuters

UK study suggests Delta subvariant less likely to cause symptoms

A subvariant of Delta that is growing in Britain is less likely to lead to symptomatic COVID-19 infection, a coronavirus prevalence survey found, adding that overall cases had dropped from a peak in October. The Imperial College London REACT-1 study, released on Thursday, found that the subvariant, known as AY.4.2, had grown to be nearly 12% of samples sequenced, but only a third had "classic" COVID symptoms, compared with nearly a half of those with the currently dominant Delta lineage AY.4. Two-thirds of people with AY.4.2 had "any" symptom, compared with more than three-quarters with AY.4.
18th Nov 2021 - Reuters

Pfizer signs $5.3 billion U.S. deal to supply COVID-19 antiviral pills

Pfizer Inc said the U.S. government would pay $5.29 billion for 10 million courses of its experimental COVID-19 antiviral drug, as the country rushes to secure promising oral treatments for the disease. The deal is for around twice as many treatment courses as Merck & Co Inc has agreed to supply the United States under its contract. The price for the Pfizer pill is nearly 25%lower at roughly $530 per course, compared with about $700 for Merck's.
18th Nov 2021 - Reuters

AstraZeneca's preventative COVID-19 shot shown to work longer-term

AstraZeneca cemented its lead in bringing a preventative COVID-19 shot to market, saying its antibody cocktail offered 83% protection over six months, providing another possible weapon in the fight against the pandemic. The therapy, called AZD7442 or Evusheld, had previously been shown to confer 77% protection against symptomatic illness after three months, in an earlier readout of the late-stage PROVENT trial in August.
18th Nov 2021 - Reuters

EU assesses GSK-Vir COVID-19 antibody therapy for authorisation

European health regulator said on Thursday it was assessing a marketing authorisation application for GSK-Vir Biotechnology's, monoclonal antibody treatment for COVID-19 and could give its opinion within two months. The drug, sotrovimab, branded as Xevudy was already under a speedy review by the European Medicines Agency (EMA), and GSK's application makes the drug the fourth application currently under EU lenses for the treatment of COVID-19.
18th Nov 2021 - Reuters

Antibody protection after mild COVID-19 may not last; an estimated 100 mln people have had long COVID

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Antibody protection from mild COVID-19 may not last Nearly everyone who had a mild case of COVID-19 still has antibodies to the coronavirus a year later, but that might not protect them from new variants, a small study suggests. Among 43 Australians who dealt with mild COVID-19 early in the pandemic, 90% still had antibodies 12 months later.
18th Nov 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Nov 2021

View this newsletter in full

Moderna seeks U.S. authorization of COVID-19 booster shots for all adults

Atrial fibrillation significantly increases a person’s risk of serious complications and death from COVID-19

A new study from researchers at Intermountain Healthcare in Salt Lake City finds that patients with atrial fibrillation, the most common type of heart arrhythmia in adults, are at significantly higher risk to experience serious complications from COVID-19 illness. The study found that patients with a history of atrial fibrillation who have COVID-19 illness are not only more likely to need hospitalization, ICU and ventilator support, but nearly 62% more likely to suffer a major cardiovascular event, such as a heart failure hospitalization, and 40% more likely to die than individuals who don’t have a history of atrial fibrillation.
17th Nov 2021 - EurekAlert!

FDA promises quick review of Pfizer booster for all adults, CDC meets Friday

The U.S. Food and Drug Administration (FDA) said on Tuesday it would review Pfizer Inc's request to authorize booster doses of COVID-19 vaccine in all adults "as expeditiously as possible," with the New York Times reporting that the regulatory nod could come as soon as Thursday.
17th Nov 2021 - Reuters

Pfizer files for U.S. authorization of promising COVID-19 antiviral pill

Pfizer Inc said on Tuesday it is seeking U.S. authorization of its experimental antiviral COVID-19 pill that cut the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial. Pfizer said it completed submission of its application for emergency use authorization of the drug, Paxlovid, with the U.S. Food and Drug Administration, including data from the drugmaker's clinical trial.
17th Nov 2021 - Reuters

Philippines approves emergency use of Novavax COVID-19 vaccine

The Philippines has approved the emergency use of a COVID-19 vaccine by Novavax Inc, its food and drug agency chief said on Wednesday, the ninth vaccine approved in the Southeast Asian country. The nanoparticle vaccine, under the brand name Covovax, will be manufactured by Serum Institute of India, and is approved for use on adults 18 and above, the agency's chief Rolando Enrique Domingo told a public briefing. Covovax, which had efficacy of 89.7% in clinical trials, will be administered in two doses not less than 21 days apart, Domingo added.
17th Nov 2021 - Reuters

EU regulator expects decision on Novavax COVID-19 shot in weeks

The European Union's drug regulator said on Wednesday it could decide on Novavax's COVID-19 vaccine approval "within weeks" if the data it has received from the drugmaker was sufficient to prove the shot's effectiveness. The protein-based vaccine, branded Nuvaxovid, has been under a rolling review since February, the European Medicines Agency (EMA) said. Such reviews allow for a speedy approval.
17th Nov 2021 - Reuters

Roche walks away from Atea partnership to develop COVID-19 pill

Roche Holding AG has ended a partnership with Atea Pharmaceuticals Inc to jointly develop a COVID-19 antiviral pill, the Swiss drugmaker said on Tuesday, a month after the drug failed to help patients in a small study. Boston-based Atea's shares fell 11% to $10.08 in extended trading, set to add to the 72% slump this year. Many companies are racing to develop an oral pill as it can be taken as an early at-home treatment to help prevent COVID-19 hospitalizations and deaths, a promising new weapon in the fight against the pandemic.
17th Nov 2021 - Reuters

U.S. secures GSK-Vir COVID-19 antibody therapy doses worth $1 bln

The United States has signed contracts worth about $1 billion for doses of the antibody-based COVID-19 treatment from Britain's GSK and U.S.-based Vir Biotechnology, as countries seek to secure promising options beyond vaccines. The drugmakers said on Wednesday the U.S. orders bring the total number of doses to be supplied to more than 750,000 globally, without specifying how many doses of the treatment, sotrovimab, the U.S. government had signed up for.
17th Nov 2021 - Reuters

COVID-19: More infectious variant of Delta virus accounts for 1 in 10 COVID cases in England

Professor Paul Elliott, director of the REACT programme at Imperial College London, said the strain "seems to be less symptomatic" than the original Delta virus - adding this is a "good thing" as it "may be spreading less far in distance" when people are coughing.
17th Nov 2021 - Sky News

Could this gene double your risk of dying from COVID-19?

GlaxoSmithKline and Vir finally score $1B supply deal for COVID antibody—6 months after FDA nod

It was a long time coming but GlaxoSmithKline and Vir Biotechnology have finally secured a supply deal with the United States for their COVID-19 antibody treatment—six months after it scored an FDA emergency authorization. The U.S. will pay $1 billion to expand access to sotrovimab throughout the country. While the green light for sotrovimab—known commercially as Xevudy—came in May, the therapy has been available in more than half of the states in the U.S., which were free to make separate deals to acquire it. GSK said it will supply the contracted doses by Dec. 17. There is an option for the U.S. to purchase additional doses by March 2022. GSK did not reveal how many doses are included in the agreement but said it has now secured contracts to sell more than 750,000 doses worldwide. Japan, Australia and Canada are among the countries that have inked supply deals for sovrotimab.
17th Nov 2021 - FiercePharma

Johnson and Johnson’s new vaccines leader talks Covid-19, pipeline plans, and ‘a golden opportunity’ for clinical trials

There’s a changing of the guard at Janssen, Johnson & Johnson’s vaccines division. In June, the company announced that Penny Heaton, formerly the founding CEO of the Bill and Melinda Gates Medical Research Institute, was joining Janssen as the global therapeutic area head for vaccines, taking over from Johan Van Hoof, who retires at the end of 2021. Heaton’s CV shows her chops. She also previously worked for Merck, Novartis, and Novavax, and earlier in her career at the Centers for Disease Control and Prevention. As she faces her first J&J Pharma Day on Wednesday — actually a two-day event for analysts — STAT caught up to Heaton to ask her about her plans for Janssen’s vaccines division. We discussed the company’s Covid-19 vaccine, made with an adenovirus 26 delivery system that is also used in its Ebola vaccine, which has been licensed in Europe. We also talked about Janssen’s promising vaccine to protect adults against respiratory syncytial virus or RSV, now in a Phase 3 clinical trial, and other things in its pipeline.
17th Nov 2021 - STAT News

With 128 Covid vaccines in clinical development, we don’t know if the approved/authorized ones are the best ones

Pfizer/BioNTech. Moderna. Johnson & Johnson. AstraZeneca. These are the marquee names that spring to mind when you think of the vaccine companies at the forefront of the global fight against Covid-19. And for good reason: together they have manufactured the majority of the estimated 7 billion-plus Covid vaccine doses administered to date around the world. But as regulators in the U.S., Europe, and around the world mull the most responsible way to expand vaccine eligibility to an even larger share of their populations — including to younger children, as the Food and Drug Administration (FDA) and Centers for Disease Control (CDC) have done this month by greenlighting Pfizer’s vaccine for kids 5 to 11 years of age — it’s time to confront an uncomfortable reality: The global health community still doesn’t know which of the hundreds of Covid vaccines currently in clinical and preclinical development are truly “the best.” That’s a shortcoming governments and the global health system need to address if they are to ensure that the next pandemic doesn’t knock the world on its heels to the extent the novel coronavirus has done.
17th Nov 2021 - STAT News

Pfizer agrees to allow generic versions of its COVID pill

Pharmaceutical giant Pfizer has signed a deal enabling the production and supply of its experimental COVID anti-viral drug in dozens of lower- and middle-income countries. The agreement between the US company and the UN-backed international public health group Medical Patent Pool (MPP) would allow producers to manufacture and supply generic versions of the drug in 95 countries without the threat of patent infringement.
16th Nov 2021 - Aljazeera.com

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Nov 2021

View this newsletter in full

Pfizer Asks F.D.A. to Authorize Covid Pill For Unvaccinated People

Pfizer has applied to the Food and Drug Administration to authorize its antiviral pill to treat unvaccinated people with Covid-19 who are at high risk of becoming severely ill, the company said on Tuesday. The drug, which will be sold under the brand name Paxlovid, could become available within weeks if authorization is granted. It is meant to be dispensed by pharmacies and taken at home. Paxlovid is the second antiviral pill to show effectiveness against Covid, in a new class of treatments for the disease that are expected to reach far more patients than other drugs that are typically given by infusion.
16th Nov 2021 - The New York Times

Pfizer Submits Covid-19 Pill for FDA Authorization

Pfizer Inc. said it asked U.S. health regulators to authorize its oral Covid-19 drug for use in high-risk patients, putting the pill on a path that could make it available for people to take at home by the end of the year. Clearance from the U.S. Food and Drug Administration would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease. “There is an urgent need for lifesaving treatment options,” Pfizer Chief Executive Albert Bourla said Thursday. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”
16th Nov 2021 - The Wall Street Journal

Why Impact of 'Long Covid' Could Outlast the Pandemic

Millions of people who have gotten Covid-19 and survived are finding that a full recovery can be frustratingly elusive. Weeks or even months after seemingly recovering from even a mild case, many patients still confront a wide range of health problems. As researchers try to measure the duration and depth of what’s being called “long Covid,” specialized, post–acute Covid clinics are opening to handle the patients. The scale of the pandemic and persistence of some of Covid’s disabling effects mean the economic pain and drain on health resources could continue well after the contagion ends.
16th Nov 2021 - Bloomberg

NHS boss Amanda Pritchard reveals health service is preparing a yearly Covid booster programme

Amanda Pritchard said the NHS is putting plans in place for yearly booster jabs JCVI recommended booster programme should be extended to all over-40s Ms Pritchard urged people to take up vaccination invitations 'as soon as possible'
16th Nov 2021 - Daily Mail

Three doses of COVID-19 mRNA vaccination safe in high-risk populations

Earlier reports have suggested the high effectiveness of messenger ribonucleic acid (mRNA) coronavirus disease (COVID-19) vaccines at preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, their efficacy against mild COVID-19 disease appears to wane over time. Thus, the need for additional/booster vaccine doses is being contemplated. This retrospective study included adults within the Mayo Clinic Enterprise who were vaccinated with three doses of United States Food and Drug Administration (FDA)-approved mRNA-based COVID-19 vaccines from December 1, 2020, to October 17, 2021. Participants received the first two doses of BNT162b2 or mRNA-1273 according to the emergency use authorization (EUA) protocol. The study participants were administered a third dose of the same vaccine type as the original two doses at least 28 days after the second dose. All subjects were followed up for at least 14 days after their third vaccine dose.
16th Nov 2021 - News-Medical.Net

More than 10,000 Australians have filed coronavirus vaccine injury claims

Taxpayers are facing a hefty bill for rare but significant coronavirus vaccine injuries, with at least 10,000 people planning to claim under the federal government’s no-fault indemnity scheme. Services Australia is building an online portal, to be launched next month, for uncapped claims above $5000 from those who suffered injury and loss of income due to their COVID-19 vaccine, with compensation for medical costs and lost wages to be paid by the government.
16th Nov 2021 - Sydney Morning Herald

Researchers find way to filter coronavirus particles out of the air

A study by researchers suggests that air filters can remove almost all airborne traces of COVID-19. The findings by the University of Cambridge and Addenbrooke's Hospital could not only improve the safety of "surge wards" but also opens up the possibility of setting standards for cleaner air to reduce the risk of indoor transmission. With fears growing of another potential wave this winter, the discovery could allow hospitals to better manage their repurposed "surge wards" which can often lack the ability to change the air with a high frequency.
16th Nov 2021 - Sky News

Jabs have given us a tactical advantage over Covid-19 – squandering it now would be reckless in the extreme

Now the spectre of Christmas cancelled is raised, an attempt to jolt millions out of complacency and into action. In other European countries – notably Austria, Netherlands, France, Italy and Germany – Covid-19 infections are climbing. Here in Britain, we have relied on high vaccination rates to keep hospitalisations and deaths low, even when infections have spiked. Squandering that tactical advantage over Covid-19 would be reckless in the extreme. From next week, booster jabs will be offered to eight million over-40s. Third doses cut the risk of infection by more than 80 per cent. So far the middle-aged are not coming forward in the numbers needed. While three-quarters of eligible over-70s have had their booster, just half of those in their 50s have taken up the offer.
16th Nov 2021 - iNews

How food can help recovery from Covid-19

Eating advice for people recovering from Covid-19 is now available online. The Recovery Knowledge Hub, external, launched by the University of Plymouth, asks people about their current diet and offers tips and ideas to improve it. The hub is aimed at everyone who wants advice, from the public to professionals and it is free, said the university. "Eating the right diet is crucial to keep well physically and mentally, and a key part of recovery from Covid-19 is to make sure your diet is healthy," said Mary Hickson, professor in dietetics at the university.
16th Nov 2021 - BBC News

COVID-19: Boosters not only replenish immunity against transmission but lift it too, new data shows

These two types of protection - against transmission and against severe disease - are both very important, but they are also quite different. Just because a particular vaccine is good at one thing doesn't necessarily mean it's equally good at the other thing. Just because a particular vaccine's effectiveness at preventing transmission is waning doesn't necessarily mean its effectiveness at preventing serious disease is diminishing at the same rate. I say all of this not just because the two types of protection are often conflated (though they are) but because keeping this distinction under your hat is quite important when navigating all the data around COVID and vaccines.
16th Nov 2021 - Sky News

Moderna says EU to donate over 70 mln doses of its COVID-19 vaccine

Moderna Inc said it signed an agreement that enables European Union and European Economic Area countries to donate over 70 million doses of its COVID-19 vaccine to the COVAX vaccine sharing scheme for low-and-middle income countries.
16th Nov 2021 - Reuters

AstraZeneca-Oxford COVID-19 vaccine supply hits two billion doses

Two billion doses of the AstraZeneca-Oxford University COVID-19 vaccine have been supplied worldwide, the Anglo-Swedish drugmaker and its partner said on Tuesday, in just under a year since its first approval. The shot, which is the biggest contributor to the COVAX vaccine sharing scheme backed by the World Health Organization, is being made in 15 countries for supply to more than 170 countries, London-listed AstraZeneca and Oxford University said in a joint statement. AstraZeneca in June last year signed on India's Serum Institute, the world's biggest manufacturer of vaccines by volume, to help double the vaccine's manufacturing capacity to two billion doses.
16th Nov 2021 - Reuters

Pfizer to allow generic versions of its COVID pill in 95 countries

Pfizer Inc said it will allow generic manufacturers to supply its experimental antiviral COVID-19 pill to 95 low- and middle-income countries through a licensing agreement with international public health group Medicines Patent Pool (MPP). The voluntary licensing agreement between Pfizer and the MPP will allow the UN-backed group to grant sub-licences to qualified generic drug manufacturers to make their own versions of PF-07321332. Pfizer will sell the pills it manufactures under the brand name Paxlovid.
16th Nov 2021 - Reuters

Racial disparities in kids’ vaccinations are hard to track

The rollout of COVID-19 shots for elementary-age children has exposed another blind spot in the nation’s efforts to address pandemic inequalities: Health systems have released little data on the racial breakdown of youth vaccinations, and community leaders fear that Black and Latino kids are falling behind. Only a handful of states have made public data on COVID-19 vaccinations by race and age, and the federal Centers for Disease Control and Prevention does not compile racial breakdowns either. Despite the lack of hard data, public health officials and medical professionals are mindful of disparities and have been reaching out to communities of color to overcome vaccine hesitancy. That includes going into schools, messaging in other languages, deploying mobile vaccine units and emphasizing to skeptical parents that the shots are safe and powerfully effective.
16th Nov 2021 - The Associated Press

Pfizer, like Merck, inks deal to license COVID-19 pill and boost global supply

With its highly anticipated COVID-19 oral treatment seemingly on a fast track to approval, Pfizer already is lining it up to be manufactured as a generic by countries in need. Under an agreement with the Medicines Patent Pool (MPP), Pfizer will license Paxlovid to facilitate affordable global access. The deal will allow sub-licensees to supply 95 countries that account for 53% of the world's population, Pfizer said. The arrangement mirrors the one made by Merck and Ridgeback with the MPP three weeks ago, allowing for needy countries to manufacture those drugmakers' COVID-19 pill molnupiravir. Molnupiravir also is expected to be endorsed by the FDA in the coming weeks. Both deals are contingent upon regulatory authorizations or approvals. An FDA advisory group will meet on Nov. 30 to discuss Merck's application for molnupiravir.
16th Nov 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Nov 2021

View this newsletter in full

U.K. Expands Covid-19 Booster Program to People in Their 40s

The U.K. is expanding its Covid-19 booster program to younger people as the country seeks to head off another wave of infections this winter. A third vaccine dose will be available to people aged 40 to 49 starting six months after their second shot, the government said Monday. Previously, only those over 50 and other vulnerable groups were eligible. So far, more than 12 million people have received a booster. The government is also recommending a second shot of the Pfizer Inc.-BioNTech SE vaccine for 16 and 17-year-olds. That inoculation will be given at least 12 weeks after the initial dose or a Covid infection, whichever is later.
15th Nov 2021 - Bloomberg

Novavax: SK Bioscience Submits BLA For COVID-19 Vaccine Candidate, NVX-CoV2373, To South Korea' MFDS

Novavax Inc. (NVAX) said that SK bioscience has summited a biologics license application for NVX-CoV2373, the first protein-based COVID-19 vaccine candidate, to South Korea's Ministry of Food and Drug Safety. NVX-CoV2373 is Novavax' recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant. In collaboration with Novavax, SK bioscience initiated the rolling submission process for NVX-CoV2373 to South Korea's Ministry of Food and Drug Safety in April of this year. The completion of a BLA submission to the agency marks the final review stage for authorization of NVX-CoV2373 in Korea.
15th Nov 2021 - Business Insider

Spain's Hipra gets green light for Phase II COVID vaccine trials

Spain's medicines agency has authorised Catalonia-based pharmaceutical group Hipra to test a COVID-19 vaccine it is developing on more than 1,000 volunteers, Prime Minister Pedro Sanchez said on Monday. Hipra will carry out the so-called Phase II trial - the second stage of a three-round trial process - on volunteers at 10 hospitals around Spain, Sanchez said. Speaking at an event to present how European Union recovery funds will be channelled into health investments, Sanchez described the vaccine development as "extraordinary news".
15th Nov 2021 - Reuters

Why two emergency physicians’ kids took part in the Pfizer vaccine trials

Cue the collective sigh of relief from many parents across the country. While the Pfizer-BioNTech Covid-19 vaccine has been available for children ages 12 and up since mid-September, as of now 28 million even younger school-age children between the ages of 5 and 11 are eligible to receive it. As an emergency medicine physician and a parent, that reassures me. As a member of the global community, it gives me hope we’ll soon return to some level of normalcy. I acknowledge the personal decision of some parents who don’t want their kids to be vaccinated. Yet as someone whose own children were part of the vaccine’s clinical trials, I feel compelled to share the story of why my wife and I felt confident making that decision with them, and what vaccinating younger children will mean for the fate of the pandemic.
15th Nov 2021 - STAT News

8 lingering questions about the new Covid pills from Merck and Pfizer

The past two months have brought extremely good news in the fight against Covid-19. Two different oral treatments have proved effective at both preventing people newly diagnosed with Covid-19 from entering the hospital and from dying. “We’re accelerating our path out of this pandemic,” President Biden said after data on the second Covid pill became available. The wide availability of oral drugs could make Covid-19 less lethal, making it less risky for people to return to in-person work and to their normal lives. The first results, from Merck and Ridgeback Therapeutics, were released in October and will be considered by an advisory panel to the Food and Drug Administration in December. That could lead to an emergency use authorization in the U.S. by the end of the year. That drug, molnupiravir, reduced hospitalizations by 50% and prevented deaths entirely a large randomized clinical trial when it was given within five days of when symptoms began. The pill is given as a five-day course during which patients take a total of 40 pills.
15th Nov 2021 - STAT News

Non-White race tied to higher risk for COVID infection, severity

A US meta-analysis and systematic review of data on 4.3 million patients analyzed in 68 cohort and cross-sectional studies shows that, relative to White people, Black, Hispanic, and Asian populations were at higher risk for COVID-19 infection and admission to an intensive care unit (ICU) but were less likely to die of the disease. The study, published yesterday in JAMA Network Open, was designed to uncover the link between socioeconomic determinants of health and racial disparities in COVID-19 outcomes. A team led by University of California at San Diego researchers searched for COVID-19 studies that included data on race and rates of infection, disease severity, and socioeconomic status published from Jan 1, 2020, to Jan 6, 2021, well before the more transmissible Delta (B1617.2) variant was predominant in the United States.
12th Nov 2021 - CIDRAP

GlaxoSmithKline, Vir target emergency authorization for intramuscular COVID-19 antibody drug with new trial win

GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody drug sotrovimab already bears an FDA emergency use authorization (EUA) as an infusion. Now, the pair hopes to win the same status for an intramuscular formulation. The latest plan comes as a phase 3 trial showed sotrovimab, also known as Xevudy, delivered similar efficacy between intramuscular and intravenous administration routes in nonhospitalized mild to moderate COVID patients who are at high risk of disease progression. The IM administration group recorded a 2.7% rate of progression to hospitalization for over 24 hours or death through Day 29 of the trial versus 1.3% in the IV arm, the two companies reported Friday from the COMET-TAIL study. The adjusted difference of 1.07% falls within the noninferiority bar GSK and Vir previously set with the FDA.
12th Nov 2021 - FiercePharma

Late to the party: Europe on the verge of approving Roche and Celltrion antibodies for COVID

Nearly a full year after the U.S. gave Regeneron’s antibody cocktail for COVID-19 patients emergency authorization, Europe is on the verge of approving the monoclonal antibody duo. The European Medicines Agency's (EMA's) committee for human medicines also has recommended another antibody treatment for approval, Celltrion’s regdanvimab. The EMA's Committee for Medicinal Products for Human Use has passed the recommendations to the European Commission for approval. The Regeneron cocktail of casirivimab and imdevimab, which is marketed outside of the U.S. by Roche and known commercially as Ronapreve, is recommended for COVID-19 patients who do not require supplemental oxygen and are at risk to progress to a severe form of the disease. It also is recommended for use as post-exposure prophylaxis. While the recommendations cover all adults, they also include adolescents 12 years or older weighing at least 40 kilograms, or roughly 88 pounds.
12th Nov 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Nov 2021

View this newsletter in full

Bahrain authorizes AstraZeneca's anti-COVID drug for emergency use

Bahrain has approved the emergency use of AstraZeneca's (AZN.L) anti-COVID drug Evusheld, the state news agency reported on Sunday. Bahrain has become the first country to authorize the drug, which will be limited to adults who suffer from immunodeficiency or who are taking immunosuppressants, as well as individuals with occupations that put them at risk of transmission, the news agency said.
15th Nov 2021 - Reuters

More than 10,000 COVID-19 booster breakthroughs - cause for concern?

The Pfizer vaccines were not evaluated for preventing infection, but rather symptomatic or severe disease and death. And when it comes to these statistics at least for now, the vaccines seem to be doing their job. The percentage of people testing positive for the virus has declined from an aveage of more than 5% to just 0.56%. And hospitalisations have gone down too, hitting only 200 people on Friday with 20% of the patients in only a mild condition.
13th Nov 2021 - The Jerusalem Post

Covaxin, India’s homegrown COVID jab, ‘highly efficacious’: Study

Covaxin, the first COVID-19 vaccine developed in India, is “highly efficacious” and presents no safety concerns, according to a study published in the medical journal Lancet. Covaxin gained emergency approval from the World Health Organization last week, the eighth jab to be given the green light by the health body. The vaccine has already been cleared for use in 17 countries. Known by the code BBV152, Covaxin is an inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The WHO has described it as “extremely suitable for low- and middle-income countries due to easy storage requirements”. Some of the other approved vaccines must be stored at very low temperatures, which throws up logistical and cost problems.
12th Nov 2021 - Al Jazeera English

The Valneva COVID-19 vaccine: Why it might be a game-changer

French pharmaceutical company Valneva is throwing its hat into the vaccine ring, but it has a vaccine with a difference. Rather than induce an immune response that targets just the spike protein of the coronavirus, the Valneva vaccine, also known as VLA2001, stimulates an immune response to the entire virus, and that might just give it an edge over its competitors. It is different in that it uses the tried and tested method of taking the whole of the coronavirus and inactivating it so that it can no longer cause illness. It then combines with an adjuvant, a substance that helps it enter human cells effectively.
12th Nov 2021 - Al Jazeera English

WHO eyes meeting to set guidelines on COVID-19 pills

World Health Organization (WHO) officials said on Friday they were hoping to convene a meeting soon to set guidelines on the use of COVID-19 antiviral pills, saying they offered "very attractive" new prospects for clinical care. Britain became the first country to approve one of the potentially game-changing pills earlier this month. Janet Diaz, the WHO's top official for clinical care responses, said that a meeting of its guidelines development group would consider the question of COVID pills in a forthcoming meeting in three weeks. Another WHO official Mike Ryan said preliminary findings on the pills was "very, very welcome", adding that a "careful process" was not required before the therapies should be expanded more broadly.
12th Nov 2021 - Reuters

GSK-Vir COVID-19 antibody works as shot in the arm as well as infusion

Britain's GSK and partner Vir said on Friday their antibody-based COVID-19 drug was shown in a trial to work as well when given as a shot in the arm awhen administered via the standard infusion, potentially offering more convenience. GSK said it would now speak to global regulators, including the U.S. Food and Drug Administration, about potential approval for the new method of administration, known as intramuscular injection, which can be carried out by family doctors and spare patients a trip to hospital.
12th Nov 2021 - Reuters

Patients with Covid history contributing to diabetes case burden, says hospital

Experts at the hospital said inflammatory reactions after Covid could include, hypoxia, weakness, weight loss, hair loss, myocarditis, thyroid and diabetes which is being reported as one of the most common diseases.
12th Nov 2021 - Hindustan Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Nov 2021

View this newsletter in full

Covid Pills May Save Lives, But They Won’t End the Pandemic

The promise of new Covid-19 pills from Pfizer Inc. and Merck & Co. gives rise to the hopeful question: Is this how the pandemic ends? The best answer anyone can muster is “maybe.” No matter how effective the antiviral pills are, it will be months before we can say we’re near the end. The pills have been shown in studies to substantially reduce the chances that a high-risk, unvaccinated person with Covid will need hospitalization. The results rightly raised hopes. Pfizer’s drug was 89% effective, and Merck’s succeeded in about 50% of patients—potentially powerful scientific breakthroughs
11th Nov 2021 - Bloomberg

EU regulator backs COVID-19 drugs from Regeneron-Roche, Celltrion

Europe's drug regulator has recommended two COVID-19 antibody therapies - one from American-Swiss partners Regeneron-Roche and another from South Korea's Celltrion, as the region builds up its defence against surging cases. Approval by the European Commission would mark the first for any COVID-19 treatment on the continent since Gilead's remdesivir last year. Reuters reported earlier this week that the European Medicines Agency's (EMA) endorsement of the two drugs was imminent.
11th Nov 2021 - Reuters

EU regulator endorses COVID-19 drugs from Regeneron-Roche, Celltrion

India could approve Covid pill in matter of days

Antiviral drug Molnupiravir, used for treating mild to moderate Covid-19 infections, is set to enter the Indian markets within days, an official confirmed on Wednesday. Manufactured by US drug companies Merck, Sharp and Dohme, Molnupiravir is among the first proven drugs to effectively treat the viral contagion and was originally developed to treat flu. It can be taken as a pill instead of injection or intravenous administration. It could likely enter the Indian pharmaceutical markets “within days” after receiving Emergency Use Authorisation, Dr Ram Vishwakarma,
11th Nov 2021 - The Independent

Moderna COVID-19 vaccine patent dispute headed to court, U.S. NIH head says

U.S. National Institutes of Health scientists played "a major role" in developing Moderna Inc's COVID-19 vaccine and the agency intends to defend its claim as co-owner of patents on the shot, NIH Director Dr. Francis Collins told Reuters on Wednesday. In a story first reported by the New York Times on Tuesday, Moderna excluded three NIH scientists as co-inventors of a central patent for the company's multibillion-dollar COVID-19 vaccine in its application filed in July.
11th Nov 2021 - Reuters

Moderna applies for COVID-19 booster shot approval from Japan's health ministry -NHK

Moderna Inc applied for approval from Japan's health ministry on Wednesday to use their COVID-19 vaccines for booster shots, broadcaster NHK reported on Thursday. Japan plans to start administering booster shots from December this year, and has already approved the use of Pfizer COVID-19 vaccines for a third round of vaccinations on Thursday. If approved, Moderna's vaccine would become the second to be approved for booster shots in Japan.
11th Nov 2021 - Reuters

Ellume's COVID-19 home test recall most serious, FDA says

The U.S. Food and Drug Administration classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker removed some of its tests from the market last month. Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall. A 'false positive' indicates that a person has the virus when they actually do not.
11th Nov 2021 - Reuters

UK researchers identify T-cell targets for future COVID vaccines

British researchers said on Wednesday they had identified proteins in the coronavirus that are recognised by T-cells of people who are exposed to the virus but resist infection, possibly providing a new target for vaccine developers. Immunity against COVID-19 is a complex picture, and while there is evidence of waning antibody levels six months after vaccination, T-cells are also believed to play a vital role in providing protection. The University College London (UCL) researchers examined 731 health workers in two London hospitals during the first wave of the COVID-19 pandemic, and found that many had not tested positive despite likely exposure to the original coronavirus.
11th Nov 2021 - Reuters

Moderna offers COVID-19 shot at $7 to African Union - Africa CDC head

Moderna Inc has offered to sell its COVID-19 vaccines to the African Union at $7 a shot, head of the Africa Centres for Disease Control John Nkengasong said on Thursday, half the price paid by the United States earlier in the year. It is also a substantial discount to what other buyers like the European Union have agreed this year, part of a broader trend for drugmakers to sell at lower prices to lower income countries. "I am happy to say that a dose of the Moderna vaccine will be $7. That is what is being offered to us," Nkengasong told a weekly virtual media briefing.
11th Nov 2021 - Reuters

Israel pandemic advisory panel backs COVID vaccine for young children

Israel's pandemic advisory board on Wednesday backed administering Pfizer's and BioNTech's COVID-19 vaccine to children age 5-11, health officials said, as a fourth wave of infections subsides nationwide. The Health Ministry is widely expected to accept the panel's recommendation and begin rolling out the shots this month. The U.S. Food and Drug Administration has granted emergency use authorization of the vaccine for the age group at a 10-microgram dose.
11th Nov 2021 - Reuters

Diabetes problem makes Africa more vulernable to COVID-19 death, says WHO

Death rates from COVID-19 infections are much higher in patients with diabetes in Africa, where the number of people with diabetes is growing rapidly, the World Health Organization said on Thursday. A WHO analysis of data from 13 African countries found a 10.2% case fatality rate in COVID-19 patients with diabetes, compared with 2.5% for COVID-19 patients overall. "COVID-19 is delivering a clear message: fighting the diabetes epidemic in Africa is in many ways as critical as the battle against the current pandemic," said Matshidiso Moeti, WHO Regional Director for Africa, in a statement.
11th Nov 2021 - Reuters

Sleep apnea linked to COVID-19 outcomes

Sleep apnea tied to severe COVID-19 - The risk of severe illness from COVID-19 is higher in people with obstructive sleep apnea and other breathing problems that cause oxygen levels to drop during sleep, researchers say. They tracked 5,402 adults with these problems and found that roughly a third of them eventually tested posted for the coronavirus. While periodic episodes of not-breathing while asleep - leading to low oxygen levels, or hypoxia - did not increase people's chances of being infected, sleep-related hypoxia did increase infected patients' odds of needing to be hospitalized or dying from COVID-19, Drs. Cinthya Pena Orbea and Reena Mehra of the Cleveland Clinic and colleagues reported on Wednesday in JAMA Network Open. It is not clear if treatments that improve sleep apnea, such as CPAP machines that push air into patients' airways during sleep, would also reduce the risk of severe COVID-19, said Pena Orbea and Mehra.
11th Nov 2021 - Reuters

EU authorizes 2 medicines for people at risk of severe COVID

The European Medicines Agency has recommended the authorization of two new medicines against the coronavirus for people at risk of severe disease. In a statement on Thursday, the EU drug regulator said it had concluded that the monoclonal antibody treatments — a combination of casirivimab and imdevimab, and the drug regdanvimab — have both been proven to significantly reduce the risk of hospitalization and death in patients vulnerable to serious COVID-19. The EMA described the safety profile of both medicines as “favorable,” and said that despite a small number of side effects, “the medicines’ benefits are greater than their risks.” The drug combination of casirivimab and imdevimab is made by Roche; it was granted an emergency use license by the U.S. Food and Drug Administration last November.
11th Nov 2021 - The Associated Press

Merck inks yet another $1B-plus supply deal for COVID pill, this time with Japan

Merck & Co.'s positive data for oral COVID-19 antiviral molnupiravir continue to pay off in a big way. Wednesday, just a day after unveiling a $1 billion sale order to the U.S., the company disclosed another major supply deal. Japan has agreed to pay Merck and partner Ridgeback Therapeutics $1.2 billion for 1.6 million courses of the drug, or $750 per course. The deal is contingent on the antiviral winning an authorization or approval from Japan’s Pharmaceuticals and Medical Devices Agency. The deal comes a day after Merck said the U.S. government agreed to purchase another 1.4 million courses of the drug for $1 billion. Together with an earlier purchase, the order brings the United States' total supply purchase to 3.1 million courses at a cost of $2.2 billion.
11th Nov 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Nov 2021

View this newsletter in full

Next generation of Covid vaccines should target different part of virus, study says

A vaccine targeting Covid's replication proteins could knock all coronaviruses. Study found some NHS staff who tested negative had T cells against the virus. Current vaccines mainly target the spike protein to trigger antibody response
10th Nov 2021 - Daily Mail

Pfizer, BioNTech Ask FDA to Expand Covid-19 Booster Use to All Adults

Pfizer Inc. and partner BioNTech asked U.S. health regulators to expand the authorization of their Covid-19 booster to people as young as 18 years old, as the government explores expanding access to extra doses. The application opens the door for authorization of the extra dose potentially before the end of the year, which could provide millions of people with another layer of security as winter drives many indoors where the risk of transmission is higher. The Food and Drug Administration in September cleared a third dose of the Pfizer-BioNTech vaccine for adults who are 65 years and older or are at risk of severe disease and death, including because of their jobs or where they live.
10th Nov 2021 - The Wall Street Journal

Two Million Ellume Covid Tests Recalled on False Positive Risk

Ellume Ltd. is recalling 2.2 million at-home Covid-19 tests because they risk returning false positives, the U.S. Food and Drug Administration said. The regulator classified the action on Wednesday as a class I recall, the most serious kind, saying it has received 35 reports of false positives from the test made by the Australian company. Incorrect results could lead a person to wrongly receive Covid-19 treatments or isolate when they don’t need to, the FDA said. “The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false positive result,” a company spokesperson said in an email. “We have and will continue to work diligently to ensure test accuracy, in all cases.”
10th Nov 2021 - Bloomberg

U.S. Spending $650 Million to Expand Rapid Confirmatory Testing

The U.S. will spend $650 million to increase production and access to rapid diagnostic tests that can confirm the results of at-home screening, part of an effort to quickly identify and treat people with Covid-19. Peope who buy over-the-counter rapid antigen tests at pharmacies may need confirmatory testing to verify the accuracy of the result, the U.S. Department of Health and Human Services said Wednesday in a statement. The funds will help ensure such tests are readily available across the country and can provide results quickly, the agency said. The investment follows the Biden administration’s commitment of more than $3 billion for rapid home tests that may need confirmation. The earlier funding aimed to quadruple the amount of rapid home tests available in the U.S. by December, to about 200 million a month.
10th Nov 2021 - Bloomberg

French company Valneva wins deal with European Commission over COVID-19 vaccines

French vaccines company Valneva's share price jumped more than 20% on Wednesday after it won European Commission approval for a deal under which it would supply up to 60 million doses of its COVID-19 vaccine candidate over two years. The eighth such deal by the European Union's executive body in the fight against rising infections is a welcome boost for Valneva as it negotiates what has been a bumpy road for its COVID-19 vaccine. "The Valneva vaccine adds another option to our broad portfolio, once it is proven to be safe and effective by the European Medicines Agency (EMA)," EU health commissioner Stella Kyriakides said.
10th Nov 2021 - Reuters

Israeli MRI study finds heart damage from COVID-19 vaccine is rare and mild

A study conducted by Beilinson Hospital in Petah Tikva, using a detailed scanning technique to examine patients with symptoms of a heart muscle condition after receiving a COVID-19 vaccine, found that damage was rare, mild, and expected to heal. The study used cardiac magnetic resonance imaging on patients diagnosed with myocarditis, a weakening of the heart muscles that has been found in a few patients after they were inoculated. A link has been seen in recent months between coronavirus vaccines using mRNA technology and very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart).
10th Nov 2021 - The Times of Israel

Pfizer asks FDA for broader authorization of vaccine booster

Pfizer and its German partner, BioNTech, on Tuesday asked the Food and Drug Administration to authorize a booster dose of its coronavirus vaccine for people 18 and older. The FDA could clear the request by the end of the month, according to health officials who spoke on the condition of anonymity because they were not authorized to discuss the issue. The officials are concerned about studies showing waning vaccine protection, as well as increased infections in parts of the United States. Currently, the government recommends the Pfizer-BioNTech booster vaccine for people 65 and older and those 18 to 64 who are at high risk of covid-19, the disease caused by the virus, because of underlying medical conditions or potential exposures at work or in their living situation.
10th Nov 2021 - The Washington Post

COVID-19 tests may be more accurate in the afternoon

A new study finds that the accuracy of reverse transcription-polymerase chain reaction (RT-PCR) COVID-19 tests follows a daily pattern. The highest number of accurate positive results occur with midafternoon tests, while evening tests increase the number of false positives. The study also suggests that midafternoon is the time of day at which both symptomatic and asymptomatic individuals are most likely to pass on the SARS-CoV-2 virus to others.
10th Nov 2021 - Medical News Today

Germany recommends only Biontech/Pfizer vaccine for under-30s

Panel recommends only Biontech/Pfizer for under-30s. Makes similar recommendation for pregnant women. More heart inflammation cases with Moderna jab-data. Germany sees record number of COVID cases for third day
10th Nov 2021 - Reuters

Vietnam approves India's COVID-19 vaccine Covaxin

Vietnam has approved India's Covaxin vaccine for emergency use, the ninth to be endorsed in the country, the country's health ministry said on Wednesday. The government said in July it was seeking to secure 15 million doses of the Covaxin vaccine made by Bharat Biotech.
10th Nov 2021 - Reuters

BioNTech CEO says new COVID pills unlikely to dent vaccination uptake

The Chief Executive of COVID-19 vaccine pioneer BioNTech said he does not expect for now that new oral treatments against the viral infection would considerably reduce demand for vaccines. Oral antiviral pills from Merck & Co and Pfizer Inc have been shown to significantly blunt the worst outcomes of COVID-19. I really don’t believe that it will have a huge impact on the vaccination rate in future but we have to monitor the field," BioNTech CEO Ugur Sahin told an analyst call
10th Nov 2021 - Reuters

Pfizer seeks FDA nod for COVID vaccine boosters for U.S. adults

Pfizer Inc and BioNTech on Tuesday requested the U.S. Food and Drug Administration (FDA) to authorize booster doses of their COVID-19 vaccine in all adults, presenting recent data showing the shot would help prevent disease across ages. Over the past several months, the FDA has authorized Pfizer's boosters for people who are immunocompromised, those who are aged 65 and above, all people at high risk of severe disease, and people who are regularly exposed to the virus.
10th Nov 2021 - Reuters

EU to decide on Moderna's COVID-19 shot for younger kids in two months

The European Union's drug regulator expects to decide in about two months on whether to allow the use of Moderna's COVID-19 vaccine in children aged six to 11 years, it said on Wednesday, after the U.S. drugmaker sought approval. "The current timeline for evaluation foresees an opinion in approximately 2 months, unless supplementary information or analysis is needed," the European Medicines Agency (EMA) said in a statement.
10th Nov 2021 - Reuters

Long COVID symptoms may have causes other than SARS-CoV-2

A French study finds that, of 20 persistent physical symptoms reported by adults who said they had recovered from COVID-19, only 1 was linked to SARS-CoV-2 infection, as indicated by the presence of antibodies to the virus. The researchers, however, said that the results don't discount the presence of symptoms but rather underscore the importance of considering all possible causes in addition to COVID-19, such as other diseases, anxiety, or deconditioning related to the pandemic but not the virus itself. The study, published yesterday in JAMA Internal Medicine, involved analysis of blood samples from 26,823 adult participants who reported recovering from COVID-19.
10th Nov 2021 - CIDRAP

Moderna, U.S. clash in patent dispute over origins of COVID-19 vaccine: report

The public/private partnership between the U.S. government and Moderna to quickly develop a COVID-19 vaccine has been lauded as a feel-good success story—and a blueprint for future health crises. But less than a year after Moderna gained FDA authorization for its vaccine, its marriage with the feds is on the rocks. The company has done little appease the Biden administration’s call to make the vaccine available to poor countries, and now a much bigger battle over patent rights is brewing, The New York Times reports. The issue surrounds a July filing by Moderna with the U.S. Patent and Trademark Office which claims that it invented the vaccine. Meanwhile, the NIH says that three of its scientists created key elements of the shot.
10th Nov 2021 - Fierce Pharma

AstraZeneca creates unit to handle its COVID-19 vaccines, antibody treatments

As AstraZeneca suffered a series of missteps in the development, manufacture and distribution of its COVID-19 vaccine, other companies surged ahead in the race to provide shots to the world. Was AstraZeneca ill equipped for the monumental task? With the creation of a new unit responsible for COVID-19 treatments, including vaccines and antibodies, the company is attempting to better manage its response to the pandemic. Iskra Reic, a senior executive who heads up the company’s operations in Europe and Canada, will take control of the division, allowing CEO Pascal Soriot to manage the company’s bread-and-butter business. The new unit will have R&D, manufacturing, commercial and medical branches.
10th Nov 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Nov 2021

View this newsletter in full

Pfizer to apply for COVID vaccine use in Brazil for children 5-11 years

Pfizer Inc plans to seek Brazil's authorization to use its COVID-19 vaccine in children aged 5 to 11 years, the country's health regulator Anvisa said on Tuesday after a meeting with the U.S. company. Pfizer representatives met with Anvisa to present technical data ahead of a formal submission of its request, the regulator said in a statement. The dose for children aged 5 to 11 years will be lower than the dose for children over the age of 12 due to a new formula developed by the company, Anvisa said.
10th Nov 2021 - Reuters

U.S. government to buy $1 billion worth of Merck's COVID-19 pill

The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc and partner Ridgeback Biotherapeutics, the companies said on Tuesday. The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more. That brings the total secured courses to 3.1 million and worth $2.2 billion. Merck said the government has the right to buy 2 million more courses as part of the contract.
9th Nov 2021 - Reuters

EXCLUSIVE Amid spike in cases, EU to shortly approve first COVID antibody drugs - sources

The European Union drugs regulator is set to authorise the use of two monoclonal antibodies to treat COVID-19 patients in coming days, two EU sources told Reuters, in its first approvals of such therapies.
9th Nov 2021 - Reuters on MSN.com

Bangladesh's Beximco to sell first generic version of Merck COVID-19 pill

A Bangladeshi drugmaker will soon begin selling the world's first generic version of Merck's COVID-19 pill, molnupiravir, which has been touted as a potential game-changer in the fight against the pandemic. Beximco Pharmaceuticals will first sell generic molnupiravir in Bangladesh before considering exports based on global regulatory approvals, it said on Tuesday. The generic version has received emergency use authorisation from Bangladesh's drug regulators.
9th Nov 2021 - Reuters

Covid-19 drove deaths up 16% in OECD countries and hit mental health, too, report finds

The Covid-19 pandemic caused a 16% rise in expected deaths among the 38 members of the Organization for Economic Cooperation and Development, hitting overall life expectancy in 24 out of 30 members, the organization said Tuesday. Life expectancy fell the most in Spain and the United States, the group said, with the United States losing 1.6 years of life per capita on average over the year and a half of the pandemic so far, and Spain losing 1.5 years, the OECD said. "COVID 19 contributed, directly and indirectly, to a 16% increase in the expected number of deaths in 2020 and the first half of 2021 across OECD countries," the group said in its report.
9th Nov 2021 - CNN

COVID-19: Pfizer antiviral pill could be available 'early in 2022' if approved

An antiviral pill to treat COVID-19 should - subject to regulatory approval - be available early next year, the UK boss of Pfizer has told Sky News. The US drugs giant announced last week that the pill had been shown to cut the risk of hospitalisation or death from the virus by 89% and Britain has already ordered 250,000 courses of the treatment.
9th Nov 2021 - Sky News

India to buy 10 mln doses of Zydus Cadila's COVID-19 shot at about $4 each

French health authorities said on Monday the number of people hospitalised because of COVID-19 went up by 156 over the past 24 hours, the highest daily rise since Aug. 23, to reach a one-month peak of 6,865. The number of patients in intensive care units (ICUs) for the disease increased by 40 to 1,141, a ninth rise in 10 days. President Emmanuel Macron will speak to the nation on Tuesday about the resurgence of COVID-19 infections as well as his economic reform programme
9th Nov 2021 - Reuters India

Analysis: COVID-19 pills are coming, but no substitute for vaccines, disease experts say

Oral antiviral pills from Merck & Co and Pfizer Inc have been shown to significantly blunt the worst outcomes of COVID-19 if taken early enough, but doctors warn vaccine hesitant people not to confuse the benefit of the treatments with prevention afforded by vaccines. While 72% of American adults have gotten a first shot of the vaccine, according to a Kaiser Family Foundation poll, the pace of vaccination has slowed, as political partisanship in the United States divides views on the value and safety of vaccines against the coronavirus.
9th Nov 2021 - Reuters

AstraZeneca's COVID-19 antibody cocktail clears first step for registration in Australia

AstraZeneca's antibody cocktail against COVID-19 received its first nod for registration in Australia, the country's medical regulatory body said on Tuesday. The Therapeutic Goods Administration said it granted provisional determination to the Anglo-Swedish drugmaker last week for its antibody cocktail, EVUSHELD, the first protective shot other than vaccines against COVID-19. The regulator said the provisional determination is the first step in the process, adding that it now expects AstraZeneca to submit an application for provisional registration shortly.
9th Nov 2021 - Reuters

Amid spike in cases, EU to shortly approve first COVID antibody drugs - sources

EMA to approve Regeneron-Roche cocktail of monoclonal antibodies. EU agency to authorise also Celltrion's antibody therapy. Full marketing authorisations expected this week - source
9th Nov 2021 - Reuters

U.S. FDA lifts clinical hold on Inovio's COVID-19 vaccine trial

Inovio Pharmaceuticals Inc said on Tuesday the U.S. Food and Drug Administration (FDA) had lifted a partial clinical hold on late-stage trial of its COVID-19 vaccine within the country. Inovio said it now has the authorization to proceed with the trial after 14 months, sending its shares up 4.6% before the bell. The FDA last year in September put the final-stage trial on hold as it sought more information from the company, including details on a delivery device used to inject genetic material into cells.
9th Nov 2021 - Reuters

French health authority advises against Moderna COVID-19 vaccine for under 30s

France's public health authority has recommended people under 30 be given Pfizer's Comirnaty COVID-19 vaccine when available instead of Moderna Inc's Spikevax jab, which carried comparatively higher risks of heart-related problems. The Haute Autorite de Sante, which does not have legal power to ban or licence drugs but acts as an advisor to the French health sector, cited "very rare" risks linked to Myocarditis, a heart disease, that had shown up in recent data on the Moderna vaccine and in a French study published on Monday.
9th Nov 2021 - Reuters

U.S. government to buy $1 billion more worth of Merck's COVID-19 pill

The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc (MRK.N) and partner Ridgeback Biotherapeutics, the companies said on Tuesday. The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more. That brings the total secured courses to 3.1 million and worth $2.2 billion. Merck said the government has the right to buy 2 million more courses as part of the contract
9th Nov 2021 - Reuters

Australia's NSW says unvaccinated 16 times more likely to die from COVID-19

Unvaccinated people are 16 times more likely to end up in intensive care units or die from COVID-19, Australia's New South Wales state said in a report, with officials urging people to get inoculated as Australia begins to live with the coronavirus. The data from New South Wales (NSW) health department out late on Monday showed only 11% of people out of 412 who died from the Delta outbreak over four months through early October were fully vaccinated. The average age of those deaths was 82. Only around 3% of people in intensive care units had two doses, while more than 63% of the 61,800 cases detected between June 16 and Oct. 7 were unvaccinated.
9th Nov 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Nov 2021

View this newsletter in full

'This is far worse than January – the vaccine hasn't saved us this time'

“We should all be rated inadequate.” The call HSJ received on Sunday lunchtime from one of the most respected chief executives in the NHS carried an air of desperation.
8th Nov 2021 - Health Service Journal

PM urges people to take booster vaccine with more than 10 million having extra jab

Boris Johnson has urged people to get their booster vaccine as it emerged more than 10 million people have had the top-up jab. Government figures showed a combined total of 10,062,704 booster and third doses have been delivered with a day-on-day rise of 409,663. The Prime Minister tweeted : “An amazing 10 million people across the UK have already come forward for their booster. “We know vaccine immunity wanes over time, so boosters are vital in keeping you and your loved ones protected through the winter.
8th Nov 2021 - Evening Standard

Indonesia reviewing Merck COVID-19 pill, up to 1 mln doses targeted

Indonesia is reviewing a COVID-19 experimental antiviral pill produced by Merck & Co Inc for domestic use, its food and drug agency chief said on Monday, ahead of a possible purchase of up to 1 million doses next month. Britain is the first country to have approved the pill, named molnupiravir, which Merck last month said halved the chance of hospitalisation or death in patients at risk for severe illness. The United States, Malaysia, South Korea, Singapore, Thailand and the Philippines are among countries interested in buying molnupiravir.
8th Nov 2021 - Reuters

Pfizer could seek broad clearance for COVID-19 vaccine boosters this week - Washington Post

Pfizer and German partner BioNTech are expected to seek authorization for their COVID-19 vaccine booster shot for people aged 18 and above as soon as this week, Washington Post reported on Monday, citing officials familiar with the situation. The U.S. Food and Drug Administration (FDA) in September authorized the extra shot for those aged 65 and above, people at high risk of severe disease, and others regularly exposed to the virus.
8th Nov 2021 - Reuters

Covid-19 and pools, lakes, beaches: Is it safe to swim?

Health agencies have stated that the coronavirus cannot be transmitted through water. However, when at the beach and public pools – especially in indoor settings – you still need to exercise Covid protocols. This is because infected people can still pass on the virus through respiratory droplets or aerosols.
8th Nov 2021 - News24

What's behind the recent rise in Covid-19 deaths in S'pore? Here are some facts you may not know

Every death means the passing of a loved one - a father, mother, brother or sister - a relative or a friend. Yet, as Singapore transits to treating Covid-19 as an endemic disease, we need to speak frankly about deaths from the disease. The commentary by Professor Teo Yik Ying in The Straits Times on Aug 13 presented the possibility that as Singapore opens up, just like the United States, Israel, Britain and many European countries have done, the number of deaths here will go up, especially among the unvaccinated, as it has done elsewhere. Since then, the overall national vaccination rate has risen to 86 per cent. Vaccination rates among seniors have also increased substantially, making Singapore one of the most highly vaccinated countries in the world. We have also rolled out vaccine boosters, which have strengthened the protection against severe disease by at least 10 times, on top of the protection conferred by two doses.
8th Nov 2021 - The Straits Times

A win for health security

What is inside a tube can be the matter of life and death. Scientists carefully transfer each patient's sample into a microplate and put it in an automated box-shaped extraction instrument. After processing it for 10 minutes, it isolates ribonucleic acid (RNA) from coronavirus cells for an RT-PCR test. The coronavirus looks like a spiky ball. Many structural proteins surround its RNA, which houses genes. After health workers swab samples, they send them to scientists. RT-PCR testing looks at the genetic code of the virus by extracting and then amplifying it until SARS-CoV-2 is detectable. In the past, RNA extraction kits were imported, but the coronavirus pandemic has led to an increase in demand and price surges. But for the first time, the National Science and Technology Development Agency (NSTDA) has unveiled homegrown RNA extraction kits for commercial use.
8th Nov 2021 - Bangkok Post

Regeneron says antibody cocktail reduces risk of contracting Covid by 80% for at least 8 MONTHS

Regeneron says its antibody cocktail REGEN-COV reduces the risk of contracting COVID-19 by 81.6% two to eight months after it is administered. During this period, seven people in the treatment group developed Covid compared to 38 in the placebo group. None of the people given the cocktail were hospitalized with the virus compared to five who received a placebo. The drug was authorized last year as a treatment for COVID-19 but has since been expanded so it can be used as a prophylactic
8th Nov 2021 - Daily Mail

What we know about Pfizer’s ‘first of its kind’ Covid-19 antiviral pill What we know about Pfizer’s ‘first of its kind’ Covid-19 antiviral pill

PFIZER’S experimental Covid-19 pill was found to significantly reduce the risk of hospitalisation or death by 89%, in high-risk adults who have been exposed to the virus. The company announced at the weekend that, based on an interim analysis of Phase two and three clinical trials, the pill could be prescribed as an at-home treatment to help reduce illness severity, hospitalisations, and deaths. The drug, Paxlovid, is taken orally as soon as the first symptoms of Covid-19 appear, to avoid serious forms of the illness or hospitalisation. “If approved or authorised, Paxlovid, which originated in Pfizer’s laboratories, would be the first oral antiviral of its kind, a specifically designed Sars-CoV-2-3CL protease inhibitor,” said the company in a press release.
8th Nov 2021 - iol.co.za

Regeneron's antibody cocktail can protect against COVID-19 for up to 8 months, giving hope to the immunocompromised

People with compromised immune systems who are unable to develop adequate responses to vaccines may soon have an option to protect against COVID-19. A phase 3 trial of Regeneron’s antibody cocktail showed the treatment reduced the risk of infection by 81.6% over a period of two to eight months. Results previously reported in the New England Journal of Medicine from the same trial showed that REGEN-COV reduced the risk of infection by 81.4% during the first month after administration. “These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines, including people who are immunocompromised,” Myron Cohen, M.D., a University of North Carolina professor who leads the monoclonal antibody efforts for the NIH-sponsored COVID prevention network, said in a statement.
8th Nov 2021 - FiercePharma

Not all Covid waves look the same. Here’s a snapshot of the Delta surge

At first, Joyce Dombrouski thought it might just be some kind of blip. Maybe it was Montana’s summer tourists. But then, at one point this August, St. Patrick Hospital in Missoula had 30-plus Covid inpatients — “and we thought 30, a year ago, was a horrific number,” said Dombrouski, the chief executive of Providence Montana. It just kept growing. Three or four admissions a day, then five or six, then seven. The hospital was nearing capacity. There were more Covid patients in the ICU than the team had seen before, and they tended to be younger now. “Our median age has dropped to the mid-40s, and at the start of the pandemic, it was between 70 to 80,” Dombrouski went on. Then, her team got a call from Oklahoma, three wide western states away, asking if St. Patrick could take a transfer patient.
8th Nov 2021 - STAT News

Antibody levels not the only immunity marker: 5 takeaways from Covid-19 press conference on Nov 8

On Monday (Nov 8), the Singaporean multi-ministry task force tackling Covid-19 here held a press conference to announce further developments in Singapore's fight against the virus. 5 Takeaways from the eveny....
8th Nov 2021 - Straits Times

Sajid Javid says 'get Covid booster jabs to prevent restrictions over Christmas'

The Health Secretary has urged people to get booster jabs in order to prevent a return of restrictions over the approaching Christmas period. Sajid Javid thanked those who’ve already had their vaccines and said it is “not too late” for those who’ve yet to have a first and second jab to come forward. Sajid Javid has urged anyone who is eligible to come forward and receive their Covid booster and flu vaccines in the run up to Christmas. The Government is encouraging people to ‘top up’ their protection against Covid with winter approaching, as immunity from the vaccines starts to decrease after six months, especially for the elderly and vulnerable.
7th Nov 2021 - Yorkshire Post

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Nov 2021

View this newsletter in full

Novavax to complete data submission to FDA by end of the year for authorization of its coronavirus vaccine

The biotechnology company Novavax plans to submit complete data to the US Food and Drug Administration soon for possible emergency use authorization of its coronavirus vaccine, CEO Stanley Erck told CNN in a phone interview Friday.
6th Nov 2021 - CNN

Pfizer Says Covid-19 Pill Is 89% Effective in Preliminary Assessment

Pfizer Inc. said a preliminary look at study results found that its experimental pill was highly effective at preventing people at high risk of severe Covid-19 from needing hospitalization or dying, the latest encouraging performance for an early virus treatment. The company’s drug cut the risk of hospitalization or death in study subjects with mild to moderate Covid-19 by about 89% if they took the pill within three days of diagnosis, Pfizer said Friday. The drug, called Paxlovid, was also found to be generally safe and well-tolerated in the early look at ongoing study results, the company said.
6th Nov 2021 - The Wall Street Journal

Autopsies on More Covid Victims Needed to Understand Virus, Scientists Say

In an air-locked chamber in the world’s largest research hospital, Daniel Chertow and a half-dozen doctors and scientists clad in astronaut-inspired protective gear are carrying out a microscopic search inside a 26-year-old man. The patient went to the hospital with chest pain in spring 2020. He didn’t have typical Covid-19 symptoms, but Chertow wants to study him as part of a broader mission to understand where in the body the coronavirus goes and what it does in each of those places. If you’re a Covid case in Chertow’s emerging pathogens lab, you’re not there for treatment; you’re the subject of an autopsy.
6th Nov 2021 - Bloomberg

Pfizer Results Open Door to New Chapter for Covid Treatments

The world needs an easy-to-take Covid-19 treatment. Pfizer Inc.’s and Merck & Co. Inc.’s Covid pills may be just that. But questions remain about how well they will work in the real world, how safe they are and whether they will need to be taken in drug cocktails rather than alone. Pfizer’s Covid pill results were hailed as remarkable Friday, the drug reduced the risk of hospitalization or death by 89% in patients. It follows a successful Covid pill trial from rival Merck in October and both drugmakers are now working to get regulatory authorization. That’s left even the most skeptical doctors and scientists cheering the moment as a feat for drug development and a possible turning point in the pandemic.“Just stunning,” Ashish Jha, dean of the Brown University School of Public Health, said in a tweet about the results. He added that the “implications of effective therapeutics for ending the pandemic are very, very large.”
6th Nov 2021 - Bloomberg

Oral vaccines and novel tech: CEPI announces grants for 'variant-proof' COVID-19 vaccine development

CEPI, the Coalition for Epidemic Preparedness Innovations, has announced the first funding awards under a $200m program to advance development of vaccines against SARS-CoV-2 variants and other betacoronaviruses.
5th Nov 2021 - BioPharma-Reporter.com

U.S. cancels multimillion-dollar deal with coronavirus vaccine maker whose plant ruined Johnson & Johnson doses

The federal government has canceled a deal worth $628 million with Emergent BioSolutions, the Maryland-based vaccine manufacturer that was a vanguard of the Trump administration’s program to rapidly produce vaccines to counter the coronavirus pandemic. The company disclosed the development on Thursday in a conference call discussing its latest financial results. The cancellation comes after Emergent’s manufacturing facilities in Baltimore were found to have produced millions of contaminated vaccine doses this spring, prompting a months-long shutdown. Emergent will forgo about $180 million due to the contract’s termination, the company said. As part of its coronavirus efforts, the federal government had invested in building additional capacity at two of the firm’s sites.
5th Nov 2021 - The Washington Post

Is the debate over the origin of Covid-19 still worth having?

The ongoing rhetoric from Republican politicians about the origin of Covid-19 accomplishes nothing other than further polarizing U.S. society. The available public records show that the work done at the Wuhan Institute of Virology using U.S. government funds could not have created SARS-CoV-2, The most recent lab-leak related controversy has centered on grant-related paperwork violations. The scientific community has also been riven by unpleasant disputes. Allegations have been made that lab-leak opponents must have conflicts of interest, however nebulous. One positive outcome is that lab-leak theory has refocused the world’s virologists on an important scientific topic: gain-of-function research.
5th Nov 2021 - STAT News

COVID-19 vaccines more protective than 'natural' immunity

A previous infection with SARS-CoV-2 and COVID-19 vaccination can provide immunity and protection against future illness. A new study has compared the level of immunity afforded by a previous infection with the protection provided by a COVID-19 vaccine. The results suggest that COVID-19 mRNA vaccines are around five times more effective at preventing hospitalization than a previous infection.
5th Nov 2021 - Medical News Today

Novavax completes process for WHO emergency use approval of COVID-19 vaccine

Vaccine developer Novavax Inc said on Thursday it has completed the submission process for emergency use listing of its COVID-19 vaccine candidate with the World Health Organization. The company submitted to the health agency all modules required for the evaluation of NVX-CoV2373, its protein-based COVID-19 vaccine, days after receiving its first emergency use authorization from Indonesia. "The first authorization of the COVID-19 vaccine... will fill a vital need for Indonesia, which is the fourth most populous nation on earth and continues to work to procure sufficient vaccine for its population," Chief Executive Stanley Erck said during an investor call.
5th Nov 2021 - Reuters

White House says it is still committed to finding COVID's origin

The White House said on Thursday that understanding the origins of COVID-19 remains a key focus of Biden administration and that they will continue pushing for answers. "It's incredibly important for us to get to the bottom of this," said spokesperson Karine Jean-Pierre. "Time is of the essence" and the U.S. and its partners will continue to fight for transparency from China.
5th Nov 2021 - Reuters

Gene linked to doubling risk of COVID-19 death found by UK scientists

British scientists have identified a version of a gene that may be associated with double the risk of lung failure from COVID-19, a finding that provides new insights into why some people are more susceptible than othersto severe illness and which opens possibilities for targeted medicine. The high-risk genetic variant is in a chromosome region that is also tied to double the risk of death in COVID-19 patients under age 60. Around 60% of people with South Asian ancestry carry the high-risk version of the gene, researchers at Oxford University said on Friday, adding the discovery may partly explain the high number of deaths seen in some British communities, and the devastation wrought by COVID-19 in the Indian subcontinent.
5th Nov 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Nov 2021

View this newsletter in full

UK Approves Merck Covid Drug Molnupiravir to Fill In Where Vaccines Can't

The U.K. was the first country to approve a Covid-19 vaccine; it has now become the first to approve an at-home treatment for Covid. On Thursday, the medicines regulator, MHRA, green-lit the antiviral drug molnupiravir, produced by Ridgeback Biotherapeutics and Merck & Co. and shown in trials to halve the risk of hospitalization or death in those with mild to moderate disease. Health Secretary Sajid Javid called it a “historic day for our country.” For once that might not be an overstatement. Beyond Britain, the new drug should be a reminder of the importance of antivirals in the fight against this and future pandemics. The molnupiravir approval couldn’t be timelier. Britain has had a stubbornly high Covid infection rate. Although the most recent wave has not led to a marked increase in deaths from the virus, hospitals face a gargantuan backlog of delayed procedures, Covid wards are fuller than is comfortable and there are worries that a bad flu season could tip an overstretched health service into deeper crisis.
4th Nov 2021 - Bloomberg

Oxford Scientists Find Gene That Doubles Risk of Dying From Covid-19

Scientists identified a specific gene that doubles the risk of respiratory failure from Covid-19 and may go some way to explaining why some ethnic groups are more susceptible to severe disease than others. Researchers from the University of Oxford found that a higher-risk version of the gene most likely prevents the cells lining airways and the lungs from responding to the virus properly. About 60% of people with South Asian ancestry carry this version of the gene, compared with 15% of people with European heritage, according to the study published Thursday. The findings help explain why higher rates of hospitalization and death may have been seen in certain communities and on the Indian subcontinent. The authors cautioned that the gene cannot be used as a sole explanation as many other factors, such as socioeconomic conditions, play a role. Despite a significant impact from the virus to people with Afro-Caribbean ancestry, only 2% carry the higher-risk genotype. People with the gene, known as LZTFL1, would particularly benefit from vaccination, which remains the best method of protection, the authors said. The findings raise the possibility of research into treatments specific to patients with this gene, though no tailored drugs are currently available.
4th Nov 2021 - Bloomberg

Britain approves Merck's oral COVID-19 pill in world first

Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19 antiviral oral pill jointly developed by Merck and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic.
4th Nov 2021 - Reuters

AstraZeneca pulls request for Swiss approval of COVID shot

AstraZeneca said Thursday that it is withdrawing its application for approval of its COVID-19 vaccine in Switzerland because the country's medical regulator wanted to restrict its use to people over age 50. Switzerland has cleared the BioNTech-Pfizer, Moderna and Johnson & Johnson vaccines for use. However, national medical regulator Swissmedic hadn't yet granted marketing authorization for the AstraZeneca vaccine.
4th Nov 2021 - ABC News

Indian home-grown Covid-19 shot wins WHO emergency use approval

The World Health Organization (WHO) said on Wednesday that it has granted approval for Indian drugmaker Bharat Biotech's home-grown Covid-19 vaccine for emergency use listing, paving the way for it to be accepted as a valid vaccine in many poor countries. The WHO tweeted that its technical advisory group had ruled that benefits of the shot, known as Covaxin, significantly outweighed the risks and that it met WHO standards for protection against Covid-19. The decision had been delayed as the advisory group sought additional clarifications from Bharat Biotech before conducting a final risk-benefit assessment for the vaccine's global use. WHO's Strategic Advisory Group of Experts on Immunization also recommended Covaxin's use in two doses, with an interval of four weeks, in age groups 18 and above. These recommendations are in line with the company's guidance.
4th Nov 2021 - CNN

COVID-19: 'Millions of years lost' and life expectancy cut short around the world

More than 28 million "extra years of life" have been lost during the coronavirus pandemic, a new study has found. By comparing the lives cut short by COVID-19 and the estimated normal life spans of those who died, researchers, led by a team at Oxford University, calculated that millions of years of life have been lost from premature deaths. The findings also follow a significant fall in life expectancy around the globe. The new research assessed the toll of the pandemic on 37 countries, including England and Wales.
4th Nov 2021 - Sky News

No decrease in effectiveness if COVID-19 jab and flu vaccine is taken together - WHO

People can get inoculated against COVID-19 and the seasonal influenza at the same time without compromising the vaccines' effectiveness, a World Health Organization official said on Thursday. "Anybody can get both the vaccines together - there is no decrease in effectiveness of either of the vaccines when given together at one point of time," Siddhartha Datta, the WHO Europe's regional adviser for vaccines, told a news briefing.
4th Nov 2021 - Reuters

EU regulator reviewing data on AstraZeneca COVID-19 booster shots

The European Union's drug regulator said on Thursday it was in discussions with AstraZeneca (AZN.L) over possible authorisation of booster doses of the drugmaker's COVID-19 vaccine, after it already gave the green light to mRNA booster shots. "AstraZeneca is submitting data to us. Actually today they submitted a new package of data that could support an extension to use the booster," the European Medicines Agency's head of vaccines strategy, Marco Cavaleri, said at a briefing. "We will be discussing with them whether this data could be sufficient for (authorisation) or whether we need more evidence," Cavaleri added.
4th Nov 2021 - Reuters

Factbox: Countries rush to buy Merck's experimental COVID-19 pill

While the drug's approval in the United States is still pending, Britain on Thursday became the first country in the world to approve the pill. Last week the company reached a deal with the United Nations-backed Medicines Patent Pool that will allow more companies to manufacture generic versions of the pill with a royalty-free licence applying to 105 low- and middle-income countries. So far Merck has agreed to license the drug to several India-based generic drugmakers.
4th Nov 2021 - Reuters

Europe faces real threat of COVID-19 resurgence, WHO Europe head says

European countries must work harder to prevent the coronavirus spreading further as deaths and new cases surge, the World Health Organization's Europe head said on Thursday. Current transmission rates in 53 European countries are of "grave concern" and new cases are nearing record levels, exacerbated by the more transmissible Delta variant of the virus, the WHO's Hans Kluge told a media briefing. "We must change our tactics, from reacting to surges of COVID-19, to preventing them from happening in the first place,"
4th Nov 2021 - Reuters

Britain approves Merck's COVID-19 pill in world first

Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19 antiviral pill jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic. Britain's Medicines and Healthcare products Regulatory Agency (MHRA) recommended the drug, molnupiravir, for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease. It will be administered as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, the regulator said, citing clinical data
4th Nov 2021 - Reuters

UK authorizes Merck antiviral pill, 1st shown to treat COVID

Britain granted conditional authorization on Thursday to the first pill shown to successfully treat COVID-19 so far. It also is the first country to OK the treatment from drugmaker Merck, although it wasn’t immediately clear how quickly the pill would be available. The pill was licensed for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug, known molnupiravir, twice a day for five days. An antiviral pill that reduces symptoms and speeds recovery could prove groundbreaking, easing caseloads on hospitals and helping to curb outbreaks in poorer countries with fragile health systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
4th Nov 2021 - The Associated Press

Are COVID-19 boosters the same as the original vaccines?

Are COVID-19 boosters the same as the original vaccines? Yes, COVID-19 boosters use the same recipe as the original shots, despite the emergence of the more contagious delta variant. The vaccines weren’t tweaked to better match delta because they’re still working well. The vaccines work by training your body to recognize and fight the spike protein that coats the coronavirus and helps it invade the body’s cells. Delta’s mutations fortunately weren’t different enough to escape detection. The increased protection you might get from a booster adjusted to better match the delta or other variants would be marginal, says Dr. Paul Goepfert, director of the Alabama Vaccine Research Clinic at the University of Alabama at Birmingham.
4th Nov 2021 - The Associated Press

Real-world study shows J&J COVID-19 vaccine 74% effective

The Johnson & Johnson (J&J) adenovirus-based COVID-19 vaccine is 74% effective in preventing SARS-CoV-2 infection even amid phases of high Alpha (B117) and Delta (B1617.2) variant circulation, according to the preliminary findings of a real-world US study yesterday in JAMA Network Open. The comparative-effectiveness study, led by researchers from nference, a Massachusetts software company affiliated with Janssen, maker of the J&J vaccine, involved mining the Mayo Clinic electronic health records (EHRs) of 8,889 vaccinated and 88,898 matched unvaccinated adults living in 1 of 15 states from Feb 27 to Jul 22, 2021. The EHRs were from the multistate Mayo Clinic Health System. Men made up roughly half of both groups of patients, with a mean age of 52.4 years in the vaccinated group and 51.7 in the unvaccinated group.
4th Nov 2021 - CIDRAP

Shipping delays, supply chain expansions ding Moderna's COVID-19 vaccine business

Moderna has been biotech’s biggest growth story in 2021, but the company’s rate of expansion slowed considerably in recent months as shipping delays and a supply chain scale-up took a toll. In the third quarter, the mRNA biotech delivered 208 million COVID-19 vaccine doses worldwide, a figure Chief Financial Officer David Meline called a “relatively modest” increase from the 199 million doses it delivered in the second quarter. What’s behind the slowdown? Moderna shipped more doses internationally in the third quarter than in prior periods. Those shipments required “longer delivery lead times” than its earlier doses, the company said, leading to export delays. “Our supply chain became more complex, with increased deliveries” to various countries around the world, CEO Stéphane Bancel said on a conference call Thursday. Moderna has been charging lower prices to many of the recently added countries, Bancel added.
4th Nov 2021 - FiercePharma

Merck and Ridgeback's COVID-19 oral antiviral molnupiravir joins the pandemic response with U.K. nod

Since the start of the pandemic, even as vaccines and monoclonal antibodies made their way onto the market, an authorized oral antiviral therapy evaded the global response. Not anymore. Merck & Co. and Ridgeback Therapeutics' molnupiravir has scored its first authorization in the world. U.K. Regulators signed off on the oral antiviral for adults who've had a positive COVID-19 test and who have at least one risk factor. The country's Medicines and Healthcare products Regulatory Agency green-lit the drug based on an interim analysis from the phase 3 Move-Out trial. The study showed the med, given at 800 mg twice daily, reduced the risk of hospitalization or death by about 50% in adult patients who were not hospitalized or vaccinated. For the study, the mild-to-moderate patients had symptom onset within five days of randomization, and they also had at least one risk factor. Ahead of the authorization, the U.K. government inked a deal to purchase 480,000 courses from Merck. In the U.K., the drug will be marketed as Lagevrio.
4th Nov 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Nov 2021

View this newsletter in full

Court Rules Against Religious Exemption for New York Healthcare Workers’ Vaccine Mandate

A federal appellate court sided with New York officials Friday and removed a temporary injunction that had allowed healthcare workers to seek religious exemptions to the state’s Covid-19 vaccination mandate. Three judges of the U.S. Court of Appeals for the Second Circuit ruled against plaintiffs in two cases brought by healthcare workers who said New York’s mandate violated their Christian beliefs. The state required all workers in hospitals and nursing homes to receive at least one dose of Covid-19 vaccine by Sept. 27 or face termination. Similar cases have been brought challenging vaccination mandates in other states, and legal experts have said the questions they raise could end up before the U.S. Supreme Court.
3rd Nov 2021 - The Wall Street Journal

Analysis: Wide array of opponents prepare to fight Biden vaccine mandate

The country's first national COVID-19 vaccine mandate, expected to be unveiled by the Biden administration this week, is likely to unleash a frenzied legal battle that will hinge on a rarely used law and questions over federal power and authority over healthcare. States, companies, trade groups, civil liberty advocates and religious organizations are expected to rush to court with demands to stop the mandate in its tracks. Two dozen Republican state attorneys general have already vowed to use "every legal option" to fight the mandate and 40 Republican lawmakers said on Wednesday they were preparing their own challenge.
3rd Nov 2021 - Reuters

Antibodies in breast milk provide extra benefit to babies; vaccine protection varies among immunocompromised

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review. Mothers' COVID-19 antibodies provide unexpected benefit. COVID-19 antibodies passed from infected mothers to their breastfeeding newborns provide more benefit to the baby than researchers expected to see, according to a report published on Wednesday in JAMA Network Open.
3rd Nov 2021 - Reuters

U.S. rolls out COVID-19 vaccine for young children, ending long wait for some parents

Seven-year-old Gael Coreas stuck out his left arm fearlessly to receive his first COVID-19 shot at a health clinic in the nation's capital on Wednesday, wincing briefly as cameras flashed to capture the moment. Coreas was in the first cohort of young children to be inoculated as the United States on Wednesday began administering the COVID-19 vaccine to children ages 5 to 11, the latest group to become eligible for the shots that provide protection against the illness to recipients and those around them.
3rd Nov 2021 - Reuters

Saudi approves Pfizer's COVID-19 vaccine for age group 5-11

The Saudi Food and Drug Authority said on Wednesday it had given its approval to use Pfizer's COVID-19 vaccine for those between five and eleven years of age. The authority added in a statement its decision was "based on data provided by the company, which showed the vaccine met the special regulatory requirements".
3rd Nov 2021 - Reuters

JCVI failed to back youth Covid jabs despite favourable modelling

The government’s independent vaccine advisers recommended against Covid shots for healthy teenagers despite considering evidence that the jabs would reduce infections, hospitalisations and some deaths in the age group. Modelling reviewed by the Joint Committee on Vaccination and Immunisation (JCVI) in June showed that fully vaccinating 80% of 12- to 17-year-olds would lead to “large reductions” in infections and a “substantial reduction” in hospitalisations in the age group. The modelling from the University of Warwick was considered alongside calculations from Public Health England that found vaccinating healthy young people in an overlapping age group – those aged 15 to 19 – could reduce intensive care admissions and prevent two deaths per million in the teenagers receiving the shots.
3rd Nov 2021 - The Guardian

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports. In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.
3rd Nov 2021 - The BMJ

Research confirms impact of Covid-19 on doctors’ mental health

The Covid-19 crisis triggered high levels of anxiety and depression among doctors in the UK, Italy and Spain, a new study has found. The research of 5,000 survey responses, across the three countries, found Italian doctors were most likely to have suffered during the crisis last year. The study, published in the peer-reviewed journal PLOS ONE, measured the mental wellbeing of doctors in Catalonia (Spain), Italy and the UK during June, November and December 2020.
3rd Nov 2021 - The Independent

Covid-19 virus does not infect human brain cells, new study suggests

The virus that causes Covid-19 does not infect human brain cells, according to a study published in the journal Cell. The findings will raise hopes that the damage caused by Sars-CoV-2 might be more superficial and reversible than previously feared. The study contradicts earlier research that suggested the virus infects neurons in the membrane that lines the upper recesses of the nose. This membrane, called the olfactory mucosa, is where the virus first lands when it is inhaled. Within it are olfactory sensory neurons (OSNs), which are responsible for initiating smell sensations. They are tightly entwined with a kind of support cell called sustentacular cells.
3rd Nov 2021 - The Guardian

Sputnik Light produces strong level of antibodies against COVID-19 - early-stage trial

Russia's one-dose Sputnik Light vaccine had a good safety profile and induced strong immune responses especially in people who had already encountered COVID-19, according to the results of phase I and II trials published in The Lancet medical journal. The vaccine, a single-dose version of the two-dose Sputnik V vaccine unveiled last year, has already entered later phases of studies and is widely used in Russia, but the publication of the early research in a top Western journal is a milestone as Russia moves towards making Sputnik Light its main vaccine for export.
3rd Nov 2021 - Reuters

Lilly pulls COVID-19 treatment from EU review while U.S. stocks up

Eli Lilly has retracted a request for European Union approval of its antibody-based treatment for COVID-19, citing a lack of demand from EU member states as the bloc focuses on other suppliers. The European Medicines Agency (EMA) said on Tuesday it had ended its rolling review of a cocktail of two monoclonal antibodies known as etesevimab and bamlanivimab after the U.S.-based drugmaker withdrew from the process.
3rd Nov 2021 - Reuters

Indian home-grown COVID-19 shot wins WHO emergency use approval

The World Health Organization (WHO) said on Wednesday that it has granted approval for Indian drugmaker Bharat Biotech's home-grown COVID-19 vaccine for emergency use listing, paving the way for it to be accepted as a valid vaccine in many poor countries. The WHO tweeted that its technical advisory group had ruled that benefits of the shot, known as Covaxin, significantly outweighed the risks and that it met WHO standards for protection against COVID-19.
3rd Nov 2021 - Reuters India

Factbox: Countries rush to buy Merck experimental COVID-19 pill

Merck has signed eight deals to sell more than a total of 2 million courses of its experimental COVID-19 pill molnupiravir to governments around the world as countries scramble to tame the virus. It has applied for approval in the United States and said it can make 10 million courses in 2021. Last week the company reached a deal with the United Nations-backed Medicines Patent Pool that will allow more companies to manufacture generic versions of the pill with a royalty-free license applying to 105 low- and middle-income countries. So far Merck has agreed to license the drug to several India-based generic drugmakers.
3rd Nov 2021 - Reuters

Analysis: Country by country, scientists eye beginning of an end to the COVID-19 pandemic

As the devastating Delta variant surge eases in many regions of the world, scientists are charting when, and where, COVID-19 will transition to an endemic disease in 2022 and beyond, according to Reuters interviews with over a dozen leading disease experts. They expect that the first countries to emerge from the pandemic will have had some combination of high rates of vaccination and natural immunity among people who were infected with the coronavirus, such as the United States, the UK, Portugal and India. But they warn that SARS-CoV-2 remains an unpredictable virus that is mutating as it spreads through unvaccinated populations.
3rd Nov 2021 - Reuters

College football didn't fuel COVID-19 spread among players, study suggests

COVID-19 didn't appear to spread efficiently within and among teams competing in the fall 2020 Southeastern Conference (SEC) college football season, finds an observational study published late last week in JAMA Network Open. The study, led by a Texas A&M University researcher, analyzed close contacts (within 6 feet) among opposing players during official games and COVID-19 athlete testing data from Sep 26 to Dec 19, 2020. At that time, cases were surging, but the more transmissible Delta (B1617.2) SARS-CoV-2 variant had not yet been identified in the United States. This may limit the findings' generalizability to pandemic phases since the emergence of Delta.
3rd Nov 2021 - CIDRAP

Molnupiravir: another Covid-19 treatment, another opportunity to recognize inequity

The Covid-19 pandemic has disproportionately affected communities of color and those with lower socioeconomic means, two groups that overlap to a significant extent in the U.S. Merck’s submission of molnupiravir, its oral antiviral drug, to the Food and Drug Administration for emergency use authorization will only heighten inequities wrought by the pandemic. Merck and others have touted this drug as a game-changer. Although the data from randomized controlled trials have not been made available for review, the press release claims that a five day course of molnupiravir is associated with a 6.8% absolute reduction in hospitalization or death in patients with moderate Covid-19 not requiring hospitalization when the drug is taken within five days of the onset of symptoms.
3rd Nov 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Nov 2021

View this newsletter in full

Pfizer Covid Vaccine for Kids Ages 5-11 Gets CDC Advisers' Backing

Younger children across the U.S. are now eligible to receive Pfizer Inc.’s Covid-19 vaccine, after the head of the Centers for Disease Control and Prevention granted the final clearance needed for shots to begin. CDC Director Rochelle Walensky recommended the vaccine for children from 5 to 11 years old. The decision ushers in a new phase in the U.S. pandemic response, widening access to vaccines to some 28 million more people at the same time that Americans who received shots earlier in the pandemic are lining up for booster doses.
2nd Nov 2021 - Bloomberg

Pfizer/BioNTech booster vaccine reduces COVID-19 hospitalisations

International researchers have identified that the Pfizer/BioNTech booster vaccine is highly effective at reducing COVID-19 hospitalisations. Experts from the Clalit Research Institute and Harvard University have collaborated to investigate the efficacy of the Pfizer/BioNTech BNT162B2 booster vaccine against the Delta variant of SARS-CoV-2, discovering that it lowers hospitalisations from the disease. The study, based in Israel, utilised one of the world’s largest integrated health record databases, illuminating the effectiveness of a third “booster” dose of the BNT162B2 vaccine in a nationwide mass-vaccination setting. The investigation was partly funded by the recently announced Ivan and Francesca Berkowitz Family Living Laboratory.
2nd Nov 2021 - Health Europa

CDC advisers discuss Covid-19 vaccines for kids

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is meeting to discuss Pfizer's Covid-19 vaccine for children ages 5 to 11. Follow here for the latest news updates.
2nd Nov 2021 - CNN

Indonesia is first country to authorize Novavax Covid-19 vaccine

Biotechnology company Novavax said Monday that Indonesia has given the world's first emergency use authorization for its Covid-19 vaccine, which uses a different technology than currently used shots. The vaccine doesn't require the extremely cold storage temperatures that some other vaccines need, which could allow it to play an important role in increasing supplies in poorer countries around the world.
2nd Nov 2021 - NBC News

Singapore may see 2,000 Covid-19 deaths each year, minister says

Singapore could see as many 2,000 Covid-19 deaths annually over time, a minister said on Monday as the country battles its biggest surge in infections. At 0.2% Singapore's Covid-19 case fatality rate is similar to the rate of deaths from pneumonia before the pandemic struck, said Janil Puthucheary, a senior minister of state in parliament. It is also lower than other countries where cases surged before vaccination, he said. "But it does mean that over time, the absolute number of deaths from Covid-19 will rise despite the best possible medical care," he said. "We could have perhaps 2,000 deaths per year from Covid-19."
2nd Nov 2021 - CNN

AstraZeneca increases COVID-19 vaccine supply to Thailand after row

AstraZeneca Plc provided Thailand 10.5 million doses of its COVID-19 vaccine last month, the firm said on Tuesday, months after an official said the government was considering curbing exports from its local plant because of lower supplies. Thailand had been pushing for 10 million doses each month to be able to fight back against coronavirus infections in the country of about 66 million people. James Teague, managing director of AstraZeneca Thailand, said that the company had increased batchwise vaccine production by a fifth at its plant, from 580,000 doses to on average 700,000.
2nd Nov 2021 - Reuters

Austrian army dogs join growing global pack of COVID-sniffers

Austria's army has successfully trained two dogs to sniff out COVID-19, it said on Tuesday, adding to a mass of evidence that dogs can be deployed to identify carriers of the virus. Trials across the world from Thailand to Britain have found dogs can use their powerful sense of smell to detect the coronavirus with a high degree of accuracy, suggesting they could be regularly deployed as an additional line of safety at large events and border entry points. Airports in Finland and Chile began deploying dogs to screen arrivals for COVID-19 last year.
2nd Nov 2021 - Reuters

U.S. buys more doses of Lilly's COVID-19 treatment for $1.29 bln

Eli Lilly and Co said on Tuesday that the U.S. government bought 614,000 additional doses of its COVID-19 antibody therapy for $1.29 billion. The U.S. Food and Drug Administration in September revised its emergency use authorization for the company's cocktail, bamlanivimab and etesevimab, to include for use in patients who have been exposed to the virus and are at high risk for progression to severe disease. Under the deal, Lilly will supply a minimum of 400,000 doses of its treatment by Dec. 31 and the rest by Jan. 31. The new purchase is estimated to add $840 million to the company's 2021 revenue forecast and about 25 cents of additional earnings per share, Lilly said.
2nd Nov 2021 - Reuters

Two UK COVID test makers pull devices due to new review

Two producers of COVID-19 tests in Britain said on Tuesday they had pulled some of their tests from the market after a new review system came into force, which has not yet granted approval for their previously accepted products. Avacta said under the new system suppliers of COVID-19 tests had to submit information regarding their products for desktop review if they wished to remain on sale in Britain. It said it had submitted its information ahead of the Sept. 1 deadline and was still waiting for a response.
2nd Nov 2021 - Reuters

CDC panel debates: Should all school kids get COVID vaccine?

Should all school-age kids get Pfizer’s pediatric COVID-19 vaccine? That’s the question before an influential government advisory panel Tuesday. The Food and Drug Administration has authorized emergency use of kid-size doses for children ages 5 to 11. But the Centers for Disease Control and Prevention also must sign off before widespread vaccinations begin in that age group. CDC’s advisers are weighing who will get the most benefit as they deliberate whether to recommend the shots for up to 28 million more children, or perhaps only for those most vulnerable to serious illness. Their recommendation goes to the CDC’s director, Dr. Rochelle Walensky, for the final say. “Today is a monumental day in the course of this pandemic,” Walensky told the advisory panel Tuesday.
2nd Nov 2021 - The Associated Press

COVID: Medical experts step up after dismissing menstrual changes

After her first Pfizer vaccine five months ago, Dahye Yim, 30, noticed something different with her menstrual cycle.Unusually heavier and with more physical symptoms such as a migraine, she went online to see if other women had experienced post-vaccine cyclical changes. She uncovered similar stories but failed to find scientifically-backed information on possible short-term vaccine side effects. The South Korean national, a PhD student based between London and Berlin, told Al Jazeera: “After I received my second dose in September, I noticed a lump under my armpit and I was able to find out very easily that this was a side effect that was nothing to worry about. This helped me calm down.
2nd Nov 2021 - Scientific American

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Nov 2021

View this newsletter in full

COVID vaccine for younger kids already being packed, shipped

Anticipating a green light from vaccine advisers, the Biden administration is assembling and shipping millions of COVID-19 shots for children ages 5-11, the White House said Monday. The first could go into kids’ arms by midweek. “We are not waiting on the operations and logistics,” said coronavirus coordinator Jeff Zients. By vaccinating children, the U.S. hopes to head off another coronavirus wave during the cold-weather months when people spend more time indoors and respiratory illnesses can spread more easily. Cases have been declining for weeks, but the virus has repeatedly shown its ability to stage a comeback and more easily transmissible mutations are a persistent threat.
1st Nov 2021 - The Associated Press

New Delta coronavirus subvariant AY.4.2: What we know so far

Health officials and scientists are closely tracking a new mutation of the coronavirus amid concerns that it could be more transmissible than the original strain. A subvariant of the Delta variant of the virus labelled AY.
1st Nov 2021 - Al Jazeera English on MSN.com

Moderna Confirms FDA Delayed Covid-19 Vaccine in Adolescents to Review Myocarditis Risk

The Food and Drug Administration is delaying a decision on Moderna Inc.’s MRNA application to authorize use of its Covid-19 vaccine in adolescents to assess whether the shot leads to a heightened risk of myocarditis, the company said. The FDA notified Moderna on Friday evening that an analysis may not be completed until January of next year while the agency reviews recent international data on the risk of myocarditis after vaccination, the company said Sunday. The Wall Street Journal reported earlier this month that the FDA was delaying a decision on Moderna’s application for authorization in 12- to 17-year-olds after several Nordic countries limited use due to myocarditis reports.
1st Nov 2021 - The Wall Street Journal

Novavax Covid-19 Vaccine Gets First Authorization, in Indonesia

Indonesia became the first country to authorize the use of a Covid-19 vaccine developed by Novavax Inc. and manufactured by the Serum Institute of India.Novavax said Monday that Indonesia’s drug regulator cleared use of the new vaccine, called Covovax, in adults 18 years and older. The decision shows that, despite receiving substantial financial support from the U.S. government, the Novavax vaccine will be used in other countries first. Novavax said it expected additional countries to authorize the vaccine in coming weeks and months.
1st Nov 2021 - The Wall Street Journal

Novavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says

Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within "weeks," its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia. Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.
1st Nov 2021 - Reuters

Americans who received the one-dose Johnson & Johnson COVID-19 vaccine were 3.5 times as likely to develop rare blood clots compared to the general population, study finds

Recipients of the J&J COVID-19 vaccine are 3.5 times as likely to develop a rare, deadly, blood clotting condition than the general population, a new study finds. Researchers found that 8.5 J&J recipients developed the clots for every 100,000 person years, compared to only 2.5 out of the general population. Researchers found that women between aged 30 and 64 were most at risk of developing the clotting. Authorization of the vaccine was paused for ten days during April due to concerns of the blood clotting developing in women. Cerebral venous sinus thrombosis, or CVST, is a dangerous condition that can cause a person to suffer stroke, or even die
1st Nov 2021 - Daily Mail

COVID-19 News: Indonesia Grants Emergency Use To Novavax Vaccine

Indonesia granted emergency use authorization to Novavax Inc.'s COVID-19 vaccine on Monday, paving the way for other countries to allow the vaccine for emergency use as well.
1st Nov 2021 - International Business Times

Infertility is not a risk with Covid-19 vaccines for kids

It's among parents' top worries around kids getting vaccinated against Covid-19: Could the vaccine somehow impair their child's future fertility? A survey released by the Kaiser Family Foundation last week found that 66% of parents of 5- to 11-year-olds worried that vaccines might negatively impact children's fertility later on. Doctors and public health officials are united in assuring parents this is not a concern. "Unfounded claims linking COVID-19 vaccines to infertility have been scientifically disproven," the American Academy of Pediatrics -- which represents doctors who specialize in treating children -- says in a statement on its website.
1st Nov 2021 - CNN

Risk of Covid-19 death '32 times greater' if unvaccinated than if double-jabbed

The risk of death involving Covid-19 is 32 times greater in unvaccinated people than in people who have received both doses, new research suggests. Mortality rates for coronavirus deaths were found to be “consistently lower” for those who had had both jabs compared with those who had had one or no vaccinations, according to the Office for National Statistics (ONS). The research used age-standardised mortality rates, which take into account differences in age structure and population size, to allow comparisons between vaccination groups.
1st Nov 2021 - Belfast Telegraph

Breast milk shown to protect newborn babies against Covid-19

Newborn babies could have extra protection against Covid-19 by drinking their mother's breast milk, a new study has shown. Researchers at Swansea University and the University of Aberdeen found the ACE2 protein, which is commonly found in breast milk, acts as a "decoy" for the virus, trapping it in biological fluids and preventing it from infecting cells. The study may go some way to understanding why newborn babies are relatively protected against coronavirus and its harms when compared to older age groups.
1st Nov 2021 - Wales Online

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Nov 2021

View this newsletter in full

Moderna Told FDA Needs More Time to Assess Vaccine for Teenagers

Moderna Inc. said it was notified that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company’s Emergency Use Authorization request for its Covid vaccine kids aged 12 to 17 years old.
31st Oct 2021 - Bloomberg

Takeda eyeing early 2022 rollout of Novavax's COVID-19 shot in Japan - CEO

Takeda Pharmaceutical Co, the Japanese partner for Novavax Inc's COVID-19 vaccine, is preparing to seek regulatory approval for a roll out in Japan early next year, its top executive said on Friday. Novavax delayed filing for U.S. approval to the end of this year, and Politico reported this month that the Maryland-based company has faced production and quality problems. The drugmaker filed for conditional authorisation to British regulators on Wednesday and with Australia's Therapeutic Goods Administration on Friday
30th Oct 2021 - Reuters

Seniors 70 and older, front-line health workers, people who got 2 AZ doses can be offered boosters, NACI says

Canada's National Advisory Committee on Immunization (NACI) is recommending COVID-19 booster shots for all adults 80 years of age and older, and is also opening the door for certain other groups who may be at increased risk of lowered protection over time since their initial vaccinations. "Populations at highest risk of waning protection following their primary series and at highest risk of severe COVID-19 illness should be offered a booster dose of an mRNA COVID-19 vaccine at least six months after completing their primary series," NACI's new guidance released Friday said, noting that seniors 80 years and older "should" be offered a booster shot.
30th Oct 2021 - CBC.ca

Booster shot now advised for Canadians who received two shots of AstraZeneca vaccine

The National Advisory Committee on Immunization has expanded eligibility guidelines for booster shots of COVID-19 vaccines. Canada’s expert panel on COVID-19 vaccines is recommending boosters for people who received two doses of AstraZeneca or one dose of the Janssen vaccine, regardless of age, and frontline health workers who were vaccinated with mRNA shots that were spaced less than 28 days apart.
30th Oct 2021 - National Post

Covaxin approvals delay: Be transparent

Prime Minister Narendra Modi highlighted India’s contribution to the fight against coronavirus disease (Covid-19) during his intervention at the first G20 session on Saturday, foreign secretary Harsh Vardhan Shringla said. The top diplomat told a press briefing that PM Modi mentioned India’s medical supplies to over 150 countries as he spoke about the country’s vision of ‘One Earth, One Health’ for a collaborative approach in combating the pandemic. Speaking at the Group of 20 Leaders’ Summit in Rome, the prime minister conveyed that India is ready to produce 5 billion Covid-19 vaccine doses by 2022 end which will be available for the world. PM Modi invited G20 countries to make India their partner in economic recovery and supply chain diversification. “He also brought out the fact that despite challenges of the pandemic, India continued to be a trusted partner in the context of reliable supply chains,” Shringla told the special briefing in Rome.
30th Oct 2021 - Hindustan Times

Needle-free vaccine patches coming soon, say researchers and makers

Effective vaccines, without a needle: Since the start of the Covid-19 pandemic, researchers have doubled down on efforts to create patches that deliver life-saving drugs painlessly to the skin, a development that could revolutionise medicine. The technique could help save children's tears at doctors' offices, and help people who have a phobia of syringes. Beyond that, skin patches could assist with distribution efforts, because they don't have cold-chain requirements - and might even heighten vaccine efficacy. A new mouse study in the area, published in the journal Science Advances, showed promising results. The Australian-US team used patches measuring one square centimetre that were dotted with more than 5,000 microscopic spikes, "so tiny you can't actually see them," David Muller, a virologist at the University of Queensland and co-author of the paper, told AFP.
30th Oct 2021 - The Straits Times

COVID-19: US intelligence agencies admit the true origins of coronavirus may never be known

US spy agencies have admitted that the true origins of COVID-19 may never be known. The Office of the US Director of National Intelligence (ODNI) said on Friday that theories involving transmission from animals or a leak from a lab were plausible. However, the office added that analysts could not agree which was more likely or if any firm conclusion could be made at all. They did, however, dismiss suggestions that the virus originated as a bioweapon, saying backers of this theory "do not have direct access to the Wuhan Institute of Virology".
30th Oct 2021 - Sky News

Study of Hospitalized Covid-19 Patients Shows Vaccination Is Better Guard Than Prior Infection

Covid-19 was over five times more common among hospitalized people who were unvaccinated and had a previous infection, compared with those who were fully vaccinated and hadn’t had Covid-19 before, a study published by the Centers for Disease Control and Prevention found. The report, released Friday and written by scientists from the federal agency as well as hospitals across the U.S., adds to the body of research suggesting that vaccines provide stronger protection against the coronavirus than prior-infection immunity. Research into immunity to Covid-19 has been limited in part by the short window of time in which the virus has been circulating and vaccines have been in use. Few clinical studies of patients who have recovered from Covid-19 have been conducted, compared with the more robust body of clinical research into the vaccines, making it hard to reach definitive conclusions about the nature of immunity provided by prior infection.
29th Oct 2021 - The Wall Street Journal

Pfizer-BioNTech Covid-19 Vaccine Authorized for Young Children by FDA

The Covid-19 vaccine from Pfizer Inc. PFE 1.30% and BioNTech SE BNTX -1.85% was authorized for use in children as young as 5 years old, the first shot that federal health regulators have permitted for them in the U.S. The decision by the Food and Drug Administration on Friday for children age 5 to 11 paves the way for one of the last remaining groups in the U.S. to get vaccinated against Covid-19, probably starting within days. The shot works safely, the FDA said. Once the Centers for Disease Control and Prevention gives its signoff, expected within days, the young children can begin getting their first dose. The children will be given two shots three weeks apart, the same schedule as adults and adolescents, although each shot will contain one-third of the dosage.
29th Oct 2021 - The Wall Street Journal

Canada says decision on allowing Pfizer's COVID-19 vaccine for children still weeks away

A Canadian decision on whether to approve Pfizer Inc’s COVID-19 vaccine for those aged 5 to 11 will not come before mid- to end-November, a senior official said on Friday. “I think we’re still at least a few weeks away from a final decision ... we’ve received some additional information just this past week that we’rem looking through,” Supriya Sharma, the federal health ministry’s chief medical adviser, told a briefing.
29th Oct 2021 - Reuters

Moderna to supply 56.5 mln more doses of its COVID-19 shot to vaccine alliance GAVI

Moderna Inc announced a pact with the GAVI vaccine alliance to supply a further 56.5 million doses of its COVID-19 vaccine in the second quarter of next year to low- and middle-income countries. The vaccine maker said the doses will be in addition to an earlier commitment to supply 60 million doses in the second quarter of 2022 to GAVI, which co-leads the COVAX facility for equitable distribution of COVID-19 shots around the world. The COVAX facility, backed by the World Health Organization and GAVI, has delivered some 400 million COVID-19 vaccine doses to more than 140 low- and middle-income countries, but several countries run the risk of failing to meet WHO's target of 40% vaccination coverage by year-end
29th Oct 2021 - Reuters

Malaysia to buy Pfizer Covid-19 vaccine for children aged 5 to 11

Malaysia said on Friday (Oct 29) it would proceed with the procurement of the Pfizer and BioNTech Covid-19 vaccine for children, following a United States expert panel's recommendation for the shot to be authorised for those aged five to 11. A panel of advisers to the US Food and Drug Administration voted on Tuesday to recommend the authorisation, saying the benefits of the vaccine outweigh the risks. The agency's decision is still pending. Malaysia's Health Minister Khairy Jamaluddin said on Twitter that other options, such as the vaccine made by China's Sinovac BioTech, would also be considered to ensure schools can reopen safely. About 62 per cent of teenagers aged between 12 and 17 in the South-east Asian country are fully vaccinated, government statistics showed on Friday.
29th Oct 2021 - The Straits Times

Egypt receives 3rd batch of J&J COVID-19 vaccine on Monday

The Cairo International Airport will receive a third batch of Johnson & Johnson (J&J) COVID-19 vaccine on Monday, said the Egyptian Ministry of Health on Saturday. The third batch of 1,058,000 doses is part of the ministry’s plan to offer varieties of anti-Coronavirus vaccines, especially for travelers, the ministry added. The shipment will be distributed to vaccination centers allocated for travelers. The shipment arrived in Egypt as part of the initiative reached between the African Vaccine Acquisition Trust (AVAT) and UNICEF for the African Union countries. On September 4, 2021, Egypt received the second batch of 525,600 J&J doses, while the first patch of Johnson & Johnson Vaccine against coronavirus was given to Egypt on August 9, 2021. The first batch included 21,600 doses.
23rd Oct 2021 - Egypt Today

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Oct 2021

View this newsletter in full

Israel Needs More Jabs, Tourist Safeguards to Avoid Fifth Covid Wave

Israel must do more to break down vaccine resistance and implement tougher safeguards as foreign tourists start returning next month, or risk a fifth Covid-19 wave, public health experts are warning. The increasingly urgent calls will be closely monitored worldwide as Israel has often been ahead of the curve in handling the coronavirus, from sweeping restrictions and vaccine programs to renewed outbreaks as its economy reopened. It’s in the vanguard again with the world’s first widespread booster program, which dramatically brought down a surge in cases generated by the delta variant, but it’s being warned of another critical juncture ahead.
28th Oct 2021 - Bloomberg

Delta Variant Is Spread by Vaccinated and Unvaccinated People Alike, Study Shows

People inoculated against Covid-19 are just as likely to spread the delta variant of the virus to contacts in their household as those who haven’t had shots, according to new research. In a yearlong study of 621 people in the U.K. with mild Covid-19, scientists found that their peak viral load was similar regardless of vaccination status, according to a paper published Thursday in The Lancet Infectious Diseases medical journal. The analysis also found that 25% of vaccinated household contacts still contracted the disease from an index case, while 38% of those who hadn’t had shots became infected.
28th Oct 2021 - Bloomberg

UK study finds vaccinated people easily transmit Delta variant in households

The Delta coronavirus variant can transmit easily from vaccinated people to their household contacts, a British study found on Thursday, although contacts were less likely to get infected if they were vaccinated themselves. The Imperial College London study illustrates how the highly transmissible Delta variant can spread even in a vaccinated population. The researchers underlined that did not weaken the argument for vaccination as the best way of reducing serious illness from COVID-19 and said booster shots were required.
28th Oct 2021 - Reuters

WHO says seeks more data from Merck on COVID anti-viral, from Bharat on vaccine

The World Health Organization (WHO) said on Thursday that it was seeking further data from Merck on its experimental new antiviral COVID-19 pill and hoped to issue guidance in coming weeks regarding its use for mild and moderate cases. "This is a drug that we are currently evaluating and we met with Merck on Friday to discuss data from their current clinical trials that are under way in other countries," WHO expert Maria van Kerkhove told a news conference where she was asked about Merck's molnupiravir, developed with Ridgeback Biotherapeutics.
28th Oct 2021 - Reuters

Covid-19: global vaccine production is a mess and shortages are down to more than just hoarding

In March 2021 drug manufacturers predicted that 12 billion doses of covid-19 vaccine, enough to fully immunise at least 70% of the world’s population, could be manufactured by the end of the year.1 That assessment was confirmed in September in a report by the International Federation of Pharmaceutical Manufacturers and Associations,2 though it also warned that “most doses in the production queue are already allocated” to high income countries. At the time of writing, only 1.3% of people in low income countries have received their jabs. Seventy countries have yet to vaccinate 10% of their populations, and 30 countries—including much of Africa—have vaccinated fewer than 2%.3 In Latin America, only one in four of the population has received a dose of covid vaccine.
28th Oct 2021 - The BMJ

Sixty million vaccine doses to be made on Teesside if regulator gives approval

Sixty million doses of the Novavax coronavirus vaccine will be produced on Teesside if approval is given by the UK's medicine regulator. The manufacturer has submitted final data on the vaccine to the Medicine and Healthcare products Regulatory Authority (MHRA) - and anticipates a "positive decision". If successful, it would mean all 60 million doses of the vaccine Britain has ordered would be produced by Fujifilm in Billingham. Stanley Erck, Novavax president, said: "This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based Covid-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus." According to the results of a phase three trial, announced in March, the jab offers 100% protection against severe disease, including all hospital admission and death.
28th Oct 2021 - ITV News

90 per cent of people in Delhi have antibodies against Covid-19, says sero survey

More than 90 per cent of people in India’s capital city have developed antibodies against the coronavirus, according to a latest serological survey. A Delhi government official told the media: “We have found Covid antibodies in more than 90 per cent of the samples collected during the sixth round of the survey.” However, the official cautioned that “we cannot say Delhi has achieved herd immunity despite such a high level of seroprevalence.” Experts say this high level of seroprevalence indicates that Delhi might not suffer any devastating Covid waves anytime soon. But it all depends on whether any other variant of the virus emerges in the city, they cautioned.
28th Oct 2021 - The Independent

Cheap antidepressant shows promise treating early COVID-19

The pill, called fluvoxamine, would cost $4 for a course of COVID-19 treatment. By comparison, antibody IV treatments cost about $2,000 and Merck s experimental antiviral pill for COVID-19 is about $700 per course. Some experts predict various treatments eventually will be used in combination to fight the coronavirus. Researchers tested the antidepressant in nearly 1,500 Brazilians recently infected with coronavirus who were at risk of severe illness because of other health problems, such as diabetes. About half took the antidepressant at home for 10 days, the rest got dummy pills. They were tracked for four weeks to see who landed in the hospital or spent extended time in an emergency room when hospitals were full.
28th Oct 2021 - The Independent

India's Optimus Pharma seeks approval to produce generic Merck COVID-19 pill

Indian bulk drugs manufacturer Optimus Pharma is seeking domestic regulatory approval to produce a generic version of Merck & Co's oral COVID-19 treatment molnupiravir, the company's top executive told Reuters on Thursday. If granted emergency use approval, the company could scale up production to 80 million capsules a month and is targeting a price of 40 cents per capsule, said D. Srinivasa Reddy, managing director at the Hyderabad-based company.
28th Oct 2021 - Reuters

EU set to produce over 3.5 billion COVID vaccine doses in 2022 - chief executive

The European Union will produce more than 3.5 billion doses of COVID-19 vaccines next year, the head of the bloc's excutive, European Commission President Ursula von der Leyen, said on Thursday. She added that the majority of these vaccines will be shipped abroad.
28th Oct 2021 - Reuters

U.S. CDC panel to discuss COVID-19 shots for younger kids on Nov. 2

An advisory panel of the U.S. Centers for Disease Control and Prevention will meet on Nov. 2 to discuss the use of COVID-19 vaccines in children aged between 5 and 11 years. Advisors to the U.S. Food and Drug Administration had on Tuesday voted overwhelmingly to recommend that the regulator authorize Pfizer and BioNTech's vaccine for younger children.
28th Oct 2021 - Reuters

Pfizer gets U.S. contract for 50 mln COVID-19 vaccine doses for kids

Pfizer Inc and BioNTech SE said on Thursday they expect to deliver 50 million more doses of their COVID-19 vaccine to the U.S. government by April-end, as the country prepares to vaccinate children. The move comes after a panel of outside advisers to the U.S. Food and Drug Administration voted on Tuesday to recommend its authorization for the vaccine in children aged 5 to 11. The agency's decision on the vaccine for the age group is awaited. If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention's (CDC) advisory panel, the companies said they expect to then begin shipping the vaccine immediately, in 10 microgram pediatric doses, as directed by the U.S. government.
28th Oct 2021 - Reuters

Merck sees up to $7 billion in sales of COVID-19 drug through end of 2022

Merck & Co Inc on Thursday said its experimental COVID-19 drug could bring in between $5 billion and $7 billion in sales through the end of next year, assuming it gains U.S. authorization in December. Merck's shares rose more than 4% to $84.88 in early trading. The antiviral drug, molnupiravir, has been closely watched since Merck earlier this month reported data that showed it could halve the chances of dying or being hospitalized for those most at risk of developing severe COVID-19 when given early in the illness.
28th Oct 2021 - Reuters

Israel expected to recognize Russia’s Sputnik V coronavirus vaccine

Israel will likely allow tourists vaccinated with Russia’s Sputnik V coronavirus vaccine to enter Israel next month, The Jerusalem Post has confirmed. The news comes only days after Prime Minister Naftali Bennett met with Russian President Vladimir Putin, and less than a week after an announcement by the Prime Minister’s Office that only travelers inoculated with a vaccine recognized by the US Food and Drug Administration, the European Medicines Agency or the World Health Organization would be able to enter the country. Sputnik V is not approved by any of these bodies.
27th Oct 2021 - The Jerusalem Post

Study: Nearly all severely allergic people tolerate COVID vaccines

While healthcare workers at a Boston healthcare system with severe allergies reported more reactions after receiving a COVID-19 mRNA vaccine, nearly all were able to safely complete the series, according to an observational study yesterday in JAMA Network Open. Researchers at Mass General Brigham and Harvard Medical School mined the electronic health records of 52,998 employees, of whom 97.6% received both doses of vaccine, and 0.9% reported a history of high-risk allergy. The study period was Dec 14, 2020, to Feb 1, 2021. Participants completed a prevaccination allergy risk assessment and at least one postvaccination symptom survey during the 3 days after vaccination.
27th Oct 2021 - CIDRAP

FDA panel recommends Pfizer's COVID-19 vaccine for kids, setting it up for approval

The Pfizer-BioNTech mRNA COVID-19 vaccine is one step closer to winning FDA approval for use in children. But a rousing debate as to whether inoculating kids would reduce transmission of the virus, coupled with some hesitancy from parents, is raising questions about how the approval will impact demand for the shot. A positive recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday set the vaccine up for a green light in the coming days. The panel voted 17-0, with one abstention, to extend the vaccine to kids between the ages of 5 and 11. It would become the first to be approved in the United States for this age group, which includes 28 million kids. The Pfizer dosage for children is one-third the size of that for those age 12 and older. The second of the two-shot series can be administered three weeks after the first.
27th Oct 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Oct 2021

View this newsletter in full

Breakthrough infections can lead to long COVID; genes may explain critical illness in young, healthy adults

The persistent syndrome of COVID-19 after-effects known as long COVID can develop after "breakthrough" infections in vaccinated people, a new study shows. Researchers at Oxford University in the UK reviewed data on nearly 20,000 U.S. COVID-19 patients, half of whom had been vaccinated. Compared to unvaccinated patients, people who were fully vaccinated - and in particular those under age 60 - did have lower risks for death and serious complications such as lung failure, need for mechanical ventilation, ICU admission, life-threatening blood clots, seizures, and psychosis. "On the other hand," the research team reported on medRxiv on Tuesday ahead of peer review, "previous vaccination does not appear to protect against several previously documented outcomes of COVID-19 such as long COVID features, arrhythmia, joint pain, Type 2 diabetes, liver disease, sleep disorders, and mood and anxiety disorders."
28th Oct 2021 - Reuters

Flu jabs may aid COVID-19 patients who need surgery

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review. Flu-vaccinated COVID-19 patients have easier surgeries. COVID-19 patients who require surgery appear to face fewer complications if they have previously been vaccinated against the flu, new data suggest. In a preliminary study that has not yet undergone peer review, researchers analyzed outcomes after various types of surgery on nearly 44,000 COVID-19 patients worldwide, half of whom had received a flu vaccine in the previous six months
27th Oct 2021 - Reuters

Novavax Covid vaccine submitted to UK regulator for approval

The final data on the Novavax Covid vaccine has been submitted to the UK regulator for approval. The firm behind the vaccine said it anticipates a "positive decision" following the completion of its rolling regulatory submission to the Medicines and Healthcare products Regulatory Agency (MHRA). More than 15,000 people took part in the phase 3 Novavax trial at various hospital sites across the UK. Novavax said its application for conditional marketing authorisation (CMA) marks the first submission for authorisation of a protein-based coronavirus vaccine in the UK.
27th Oct 2021 - Evening Standard

Pfizer to seek Japan approval for children's COVID-19 vaccinations

U.S. pharmaceutical giant Pfizer Inc. is in talks with Japan to apply for approval to administer its COVID-19 vaccine to children aged 5 to 11, sources close to the matter said Wednesday. The revelation came a day after a U.S. Food and Drug Administration (FDA) panel of independent experts voted in favor of issuing emergency use authorization for the vaccine to be administered to children in that age group. If submitted, Japan’s Ministry of Health, Labor and Welfare plans to promptly review the application, according to the sources. Pfizer’s COVID-19 vaccine, jointly developed with German partner BioNTech SE, is currently available free of charge to people aged 12 and older in Japan, where it has been approved for use.
27th Oct 2021 - The Japan Times

Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom

Filing marks first protein-based COVID-19 vaccine submitted to MHRA for authorization. All modules required for regulatory review, including CMC data, are now complete. Submission based on Phase 3 data from ~45K patients demonstrating high efficacy and well-tolerated safety, including against variants Submissions to additional global regulatory authorities including EU, Canada and Australia expected soon
27th Oct 2021 - Business Insider

Merck strikes deal for global access to COVID-19 medication

US drugmaker Merck has announced a deal that could see generic versions of its experimental oral COVID-19 treatment for people infected with the disease widely distributed in poorer countries. The global Medicines Patent Pool (MPP), which is backed by the United Nations, said on Wednesday it had signed a voluntary licensing agreement with Merck to facilitate affordable worldwide access for its antiviral medicine molnupiravir.
27th Oct 2021 - Al Jazeera English

Nine in 10 UK adults likely to still have Covid-19 antibodies

Around nine in 10 adults in all parts of the UK continue to have Covid-19 antibodies, new figures suggest. The estimates range from 90.0% in Wales to 92.2% in England, with 90.8% for Northern Ireland and 91.3% for Scotland. The presence of coronavirus antibodies suggests someone has had the infection in the past or has been vaccinated. It takes between two and three weeks after infection or vaccination for the body to make enough antibodies to fight the virus.
27th Oct 2021 - Belfast Telegraph

Merck agrees to let other drug makers make its COVID pill

Pharmaceutical company Merck agreed to allow other drug makers to produce its COVID-19 pill, in a move aimed at helping millions of people in poorer countries get access to the potentially life-saving drug, a United Nations-backed public health organization said on Wednesday. The Medicines Patent Pool said in a statement that it had signed a voluntary licensing agreement for molnupiravir with Merck and its partner Ridgeback Biotherapeutics. The agreement will allow the Medicines Patent Pool to grant further licenses to qualified companies who are approved to make the drug. Neither drug maker will receive royalties under the agreement for as long as the World Health Organization deems COVID-19 to be global emergency. Molnupiravir is the first pill that has been shown to treat the disease.
27th Oct 2021 - The Associated Press

In a groundbreaking move, Merck and the Medicines Patent Pool ink a licensing deal for a Covid-19 pill

In a notable bid to widen access to Covid-19 remedies, Merck (MRK) has agreed to license its widely anticipated antiviral pill to the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide versions of the drug to 105 low and middle-income countries. The deal builds on a separate agreement that Merck made with eight generic companies that licensed the pill, which is called molnupiravir, in order to make knock-off copies for the same group of countries. The arrangement with the Medicines Patent Pool, however, means that still more manufacturers can now strike so-called sub-licensing deals, which would presumably increase availability more rapidly.
27th Oct 2021 - STAT News

3 takeaways from the emergence of the ‘Delta Plus’ coronavirus variant

Yet another version of the coronavirus is getting global attention, this one dubbed AY.4.2. It appears that it could be slightly more transmissible than the Delta variant — a marginal difference that experts say is more of a headache than a devastating gamechanger in the scope of the pandemic. Still, the emergence of AY.4.2 offers lessons about the ongoing evolution of the pathogen. AY.4.2 has caused some alarm because its prevalence is building up in the United Kingdom, where it’s even gained ground on the remarkably transmissible Delta variant. It now accounts for about 10% of sequenced virus samples in England. Scientists are still trying to determine what, if any, competitive advantage the newer form of the virus has over Delta, and there are a number of possible explanations for AY.4.2’s increasing frequency.
27th Oct 2021 - STAT News

WHO advisors say COVID-19 pandemic far from over

After reviewing the latest COVID-19 developments last week, the World Health Organization (WHO) emergency committee said the pandemic is far from over, though countries are making progress in rolling out vaccines and treatments. The group of outside advisors met on Oct 22 by video conference for the ninth time and unanimously agreed that the situation still warrants a public health emergency of international concern (PHEIC), which was declared on Jan 30, 2020. The group typically meets every 3 months or more often as needed.
26th Oct 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Oct 2021

View this newsletter in full

Australia drugs regulator approves booster doses of Pfizer COVID-19 vaccine

Australia's drugs regulator on Wednesday provisionally approved a booster dose of Pfizer Inc's COVID-19 vaccine for people above 18 years old as first-dose vaccination levels in the country's adult population neared 90%. The booster dose can be administered at least six months after the second shot, the Therapeutic Goods Administration (TGA) said in a statement. Further advice on the use of booster shots will be provided to the federal government soon by the country's vaccination technical advisory group, TGA said.
26th Oct 2021 - Reuters

Moderna Data Shows Covid-19 Vaccine Produced Strong Immune Response in 6- to 11-Year-Olds

Moderna Inc.’s Covid-19 vaccine was generally safe and induced the desired immune responses in children ages 6 to 11 in a clinical trial, according to the company. The Cambridge, Mass., company said Monday that it would submit the results to health regulators in the U.S., Europe and elsewhere in seeking authorization to widen the use of its shots to include this younger age group. The company announced the interim data in a press release, and results haven’t yet been published in a peer-reviewed medical journal. Moderna’s vaccine is currently authorized for use in adults 18 years and older in the U.S.
26th Oct 2021 - The Wall Street Journal

Opinion | Young Kids Should Get the Covid Vaccine. Here’s Why.

Vaccines to protect young children from Covid-19 are likely soon on their way. An advisory panel for the Food and Drug Administration voted overwhelmingly on Tuesday to recommend that the agency authorize the use of the Pfizer-BioNTech Covid-19 vaccine for those ages 5 to 11. Why do we need to vaccinate young children against Covid-19? It’s an understandable question. While many parents have anxiously awaited the opportunity to get their children vaccinated, others are hesitant. There are questions about side effects, as with any drug, especially considering the lower risk of severe disease for children with Covid-19 compared with that of adults. But just because Covid-19 is sickening and killing fewer children than adults does not mean that children are or have been free from risk.
26th Oct 2021 - The New York Times

Pfizer Says Lower-Dose Vaccine for Small Kids Could Also Work for Big Kids

Pfizer Inc.’s lower-dose Covid-19 vaccine for kids under 12 appears to offer protection across the board, company officials said, and the drug giant may look into offering lower doses for teens who now get the adult dose. A scientific advisory panel to the Food and Drug Administration is deliberating Tuesday on whether to recommend the vaccine, which Pfizer makes with partner BioNTech SE, for 5- to 11-year-olds. If cleared by regulators, it would make a Covid-19 vaccine available to all school-age children for the first time. The proposed pediatric dose is 10 micrograms, or a third of the adult Pfizer dose everyone 12 and older currently receives.
26th Oct 2021 - Bloomberg

Becton Dickinson begins selling new at-home rapid COVID-19 test

Becton Dickinson and Co has partnered with Amazon.com Inc to begin shipment of a new at-home rapid COVID-19 test that can confirm results using an entirely automated smartphone app. The BD Veritor At-Home COVID-19 Test, which was authorized by U.S. regulators in August, also automatically reports results to federal and state public health authorities. "One of the unique things about this test is that it's really the very first test to actually have an interpreted digital result," said Dave Hickey, president of Becton Dickinson's life sciences business.
26th Oct 2021 - Reuters on MSN.com

U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

An expert panel on Tuesday voted overwhelmingly to recommend the U.S. Food and Drug Administration authorize the Pfizer Inc (PFE.N) and BioNTech SE COVID-19 vaccine for children ages 5 to 11, saying the benefits of the shot outweigh the risks. An authorization for that age group would be would be an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning. The vaccine could be available to the younger age group as soon as next week. The FDA is not obligated to follow the advice of its outside experts, but usually does. The vote was 17 in favor with one abstention.
26th Oct 2021 - Reuters

FDA to debate authorizing Pfizer’s Covid vaccine for kids aged five to 11

Independent advisers for the US Food and Drug Administration (FDA) on Tuesday recommended the Pfizer-BioNTech Covid vaccine for children aged five to 11 – the first vaccine available for younger children in the US. Of 18 members, 17 voted yes and one abstained. Vaccines for children have been seen as crucial for protecting kids from the virus as well as slowing its spread, in addition to reducing the social and educational effects of school closing and attendance – and related economic concerns, such as caregivers’ ability to work. The advisers weighed the vaccine’s effectiveness, the social and physical effects of the pandemic, and the potential risk of rare side-effects like myocarditis, a type of heart inflammation. Data from Pfizer-BioNTech indicate the vaccine is 90.7% effective at preventing symptomatic illness among this age group.
26th Oct 2021 - The Guardian

S.Korea's GL Rapha certified to produce Sputnik COVID-19 vaccines

South Korean biotech firm GL Rapha has secured regulatory approval from Russia to produce and market the Sputnik family of coronavirus vaccines, the company and Russian sovereign fund RDIF said on Tuesday. The certification paves the way for the first overseas production of the shot to ease a supply shortage and allows GL Rapha to carry out the full production cycle, as opposed to other foreign manufacturers that rely on Russian-supplied ingredients. "This is the first time a foreign production partner of RDIF obtains a Russian GMP (good manufacturing practice) certificate," the two said in a joint statement.
26th Oct 2021 - Reuters

BioNTech to work with Senegal, Rwanda to make mRNA vaccines

Senegal and Rwanda have signed an agreement with German company BioNTech for the construction of its first start-to-finish factories to make messenger RNA vaccines in Africa. BioNTech, which developed the Pfizer-BioNTech COVID-19 vaccine, said Tuesday that construction will start in mid-2022. It is working with the Institut Pasteur in Dakar, Senegal’s capital, and the Rwandan government, a statement said. “State-of-the-art facilities like this will be life-savers and game-changers for Africa and could lead to millions of cutting-edge vaccines being made for Africans, by Africans in Africa,” said Matshidiso Moeti, the World Health Organization’s Regional Director for Africa.
26th Oct 2021 - The Associated Press

Indians await WHO nod for homegrown Covaxin shot to travel abroad

Stuck in a village in southern India for nine months and unable to return to his job in Saudi Arabia, Sugathan PR is hoping the World Health Organization (WHO) will approve the Indian COVID-19 shot Covaxin, paving the way for his trip back. Like Sugathan, millions of Indians have taken Covaxin and many have complained of travel struggles as the vaccine has not been recognised for international travel by several countries.
26th Oct 2021 - AlJazeera

BioNTech to start building mRNA vaccine manufacturing plant in Africa in mid-2022

BioNTech will construct a facility to make its mRNA vaccines in Africa in mid-2022 to scale up production of its COVID-19 jab for a continent that has been largely left behind in the global rollout of vaccines. Planning for the facility has been finalized and “initial assets” have been ordered, the German biotech said Tuesday. That timing sets the Pfizer partner up to potentially beat out Moderna in building the first mRNA vaccine manufacturing site on the continent. Moderna said it plans to pump $500 million into such a facility in Africa, but timing and location were kept under wraps earlier this month. "Mid-2022" is quite vague but at least puts pressure on the company to stick to a publicly disclosed time frame.
26th Oct 2021 - FiercePharma

How Moderna nearly lost the race to develop a Covid-19 vaccine

Moderna Inc. has emerged as a biotech power — and a household name — thanks to its success developing a Covid-19 vaccine. But that outcome hides what happened along the way: The company came perilously close to being the biggest loser in the race for a Covid-19 vaccine. At one point last year, Moderna CEO Stéphane Bancel was overcome with sadness because he thought he had blown the company’s opportunity to produce vaccines to help stop the pandemic. I spent 17 months investigating how the Covid-19 vaccines were developed. I spoke with more than three hundred scientists, academics, executives, government officials, investors, and others who made the Covid-19 vaccines possible. Though developing a safe and effective Covid-19 vaccine in a timeline that many called impossible was a monumental effort, the Moderna story is a stark reminder of how thin the line can be between success and failure.
26th Oct 2021 - Scientific Viewpoint

Moderna says its low-dose Covid vaccine works for kids 6 to 11

Moderna said Monday that a low dose of its Covid-19 vaccine is safe and appears to work in 6- to 11-year-olds, as the manufacturer joins its rival Pfizer in moving toward expanding shots to children. Pfizer’s kid-size vaccine doses are closer to widespread use. They are undergoing evaluation by the Food and Drug Administration for youngsters in nearly the same age group, 5 to 11, and could be available by early November. The company’s vaccine already is authorized for anyone 12 or older. Moderna hasn’t yet gotten the go-ahead to offer its vaccine to teens but is studying lower doses in younger children while it waits.
26th Oct 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Oct 2021

View this newsletter in full

WHO to consider granting EUL for Bharat Biotech's Covaxin on Tuesday

The World Health Organisation’s (WHO) technical advisory group will consider granting Emergency use listing (EUL) for Bharat Biotech's covid-19 vaccine Covaxin in a meeting scheduled on Tuesday. Soumya Swaminathan, Chief Scientist at WHO said that WHO’s goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere. “The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier," Swaminathan said in a recent tweet. If granted, the approval will hold importance of people in India vaccinated with covaxin as WHO’s approval will facilitate international travel for Indians who have received the home-made vaccine under India’s national covid vaccination programme. The delay has been impacting students and businessmen who want to travel to countries where a vaccination certificate for WHO-approved vaccines is mandatory. As on Monday over 11.70 crores doses of covaxin have been administered in India among different age group above 18. WHO’s EUL is a prerequisite for supplying vaccines under the Covax Facility, a multilateral initiative aimed at fostering global access to covid vaccines. If done, the approval, will also place Covaxin in an important spot in the world map as it can be given to more and more countries.
25th Oct 2021 - Mint

Covid Poses Bigger Risk of Brain Conditions Than Vaccines, Study Says

Covid-19 is more likely to cause rare neurological conditions than vaccines, according to a study published in the Nature Medicine journal. The study, led by the University of Oxford, analyzed the health records of 32 million people in England to identify the risks of developing rare brain conditions before and after testing positive for Covid, or receiving the first dose of either the Oxford-AstraZeneca Plc or Pfizer Inc.-BioNTech SE jabs. The researchers compared how often neurological complications occurred in set windows of time. While the vaccines were found to result in an increase of neurological complications, like Bell’s palsy and Guillain-Barré syndrome, the study found that contracting Covid presented an even bigger risk.
25th Oct 2021 - Bloomberg

EU regulator starts real-time review of Merck's COVID-19 pill

U.S. drugmaker Merck & Co Inc (MRK.N) said on Monday the European Union's drug regulator has initiated a real-time review of its experimental COVID-19 antiviral drug for adults. Under the procedure, also known as a "rolling review", the European Medicines Agency (EMA) would assess data as soon as it becomes available, instead of waiting for a formal application when all required information has been gathered. While vaccines are the main weapons against COVID-19, Merck's experimental pill molnupiravir could be a game-changer after studies showed it could halve the chances of dying or being hospitalised for those most at risk of contracting severe illness.
25th Oct 2021 - Reuters

Moderna says its COVID-19 vaccine protective, safe in young children

Moderna Inc said on Monday its COVID-19 vaccine generated a strong immune response in children aged six to 11 years and that it plans to submit the data to global regulators soon. Moderna said its two-dose vaccine generated virus-neutralizing antibodies in children and safety was comparable to what was previously seen in clinical trials of adolescents and adults. It cited interim data that has yet to be peer reviewed.
25th Oct 2021 - Reuters

Aussie scientist forced to crowd fund homegrown Covid vaccine

Dr Nikolai Petrovsky has been forced to hit GoFundMe to raise cash for Covax-19 It is the first synthetic protein vaccine for Covid to receive market authorisation It costs hundreds of thousands to gain TGA approval to release Covax locally Covax-19 showed strong protection against Delta in a Phase 3 clinical trial
25th Oct 2021 - Daily Mail

First vaccine dose could alleviate long Covid symptoms, study suggests

A first vaccine dose appears to alleviate symptoms in long Covid sufferers, a new study has suggested, although it is unclear whether this improvement lasts until a second dose. People aged 18 to 69 who had received a first dose were 12.8 per cent less likely to report that they were still experiencing persistent symptoms, according to experimental findings published by the Office for National Statistics (ONS). A second dose was associated with a further 8.8 per cent drop, with “statistical evidence” of a sustained improvement afterwards.
25th Oct 2021 - The Independent

Biological E hopes to roll out Covid vaccine Corbevax by Nov-end

Hyderabad-based Biological E Limited (BE) is expecting its coronavirus vaccine Corbevax to be rolled out by the end of November even as the city-based company is getting ready with 100 million doses for the launch, Mahima Datla, Managing Director, BE said today. While speaking to reporters on the sidelines of signing a financing agreement with US International Development Finance Corporation (DFC), Datla said currently the manufactured doses are being sent to Central Drugs Laboratory (CDL), Kasauli in Himachal Pradesh for regulatory testing.
25th Oct 2021 - Mint

Russia approves Sputnik V Covid-19 vaccination with flu shot

Sputnik V has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. The Health Ministry of Russia has reportedly granted approval for administering Covid-19 vaccine Sputnik V and flu shots simultaneously,
25th Oct 2021 - Pharmaceutical Technology

Rural areas, hit hard by COVID-19, lack access to new treatment trials

Three-quarters of rural Americans live more than an hour from the nearest site testing new treatments for COVID-19, research from the University of Virginia School of Medicine reveals. Overall, almost a third of Americans would have to travel more than 60 minutes to access new therapies as they are being tested. This geographic disparity limits access to COVID-19 clinical trials in many parts of the country that are being hit hardest by the latest wave of the pandemic. Native Americans and Alaska Natives are particularly affected, with more than 50% living more than 60 minutes from a trial site.
25th Oct 2021 - EurekAlert!

Doctors are often unaware of the only treatment for early Covid-19

On September 17, Mayra Arana made the phone call she says saved her life. Arana had been vaccinated against Covid-19, but she developed a breakthrough infection. She feared the virus might kill her, since her immune system is weak after years of treatment for leukemia. Arana's family physician in California told her there wasn't much she could do besides stay home and rest. At home, following her doctor's advice, Arana felt sicker by the hour. Her husband placed a pulse oximeter on her fingertip, and it showed her blood oxygen levels were dipping dangerously low.
25th Oct 2021 - CNN

India's Biological E., U.S. body finalise $50 mln COVID-19 shot financing deal

The United States and India's Biological E. Ltd said on Monday they had finalised a financing arrangement for $50 million to expand the vaccine maker's capacity to produce COVID-19 shots. The agreement was struck in March when leaders of the United States, Australia, Japan and India - the so-called "Quad" countries - met during a virtual summit. The United States had said it would work via its International Development Finance Corp to finance Biological E.'s efforts to produce at least 1 billion COVID-19 vaccine doses for India and developing countries by the end of 2022
25th Oct 2021 - Reuters India

S.Africa's Aspen aiming for 1.3 bln dose/year COVID-19 vaccine capacity by 2024

South Africa's Aspen Pharmacare is aiming to ramp up its COVID-19 vaccine manufacturing capacity to 1.3 billion doses a year by February 2024, up from annual output of around 250 million doses now, the company's CEO told Reuters. Aspen is doing the final stages of manufacturing for Johnson & Johnson's COVID-19 vaccine in a so-called "fill and finish" deal, but CEO Stephen Saad said in an interview that the companies were close to announcing a broader deal for Aspen to produce Johnson & Johnson's COVID-19 shot under licence.
25th Oct 2021 - Reuters

Fake, substandard vaccines and medicines spell trouble for controlling Covid-19

A notable rallying cry that emerged early during the Covid-19 pandemic was “flatten the curve.” It reflected the reality that hospitals lacked the resources, knowledge, and therapies to accommodate everyone in need. Nearly 18 months later, the situation around the globe is different. Clinicians have a better understanding of how to prevent Covid-19, and how treat people with severe cases of it. Vaccines have brought much-needed relief. But the picture is now being complicated by the emergence of substandard and falsified Covid-19 vaccines and medical products, which are becoming increasingly pervasive.
25th Oct 2021 - STAT News

Africa tries to end vaccine inequity by replicating its own

In a pair of Cape Town warehouses converted into a maze of airlocked sterile rooms, young scientists are assembling and calibrating the equipment needed to reverse engineer a coronavirus vaccine that has yet to reach South Africa and most of the world’s poorest people. The energy in the gleaming labs matches the urgency of their mission to narrow vaccine disparities. By working to replicate Moderna’s COVID-19 shot, the scientists are effectively making an end run around an industry that has vastly prioritized rich countries over poor in both sales and manufacturing. And they are doing it with unusual backing from the World Health Organization, which is coordinating a vaccine research, training and production hub in South Africa along with a related supply chain for critical raw materials. It’s a last-resort effort to make doses for people going without, and the intellectual property implications are still murky.
25th Oct 2021 - The Associated Press

EU medicines watchdog starts review of Merck COVID pill

The European Medicines Agency (EMA) – the European Union’s top medicines watchdog – has started a review of a potentially ground-breaking antiviral pill to treat COVID-19. The agency announced on Monday that it has launched a “rolling review” of molnupiravir, which was developed by United States pharmaceutical company Merck.
25th Oct 2021 - AlJazeera

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Oct 2021

View this newsletter in full

‘Darker skies and colder weather provide perfect conditions... for Covid-19 to thrive’

Joe Buglass tried 46 times to call his GP about booking a Covid booster jab last Wednesday. “The phone was just ringing and ringing,” he said. He had tried several times over the previous six weeks, since getting an NHS text message. “You click the link and it gives you the doctors’ surgery number,” he said. Buglass, who runs a property maintenance business in Newcastle, is clinically vulnerable because he donated a kidney. When he finally got through, he was told he was ringing the wrong people. Eventually, someone rang him back. “They told me that because the clinics were finishing this Sunday, they didn’t have any bookings for the next few weeks,” Buglass said. He was incredulous. “Where do I go from here?
24th Oct 2021 - The Guardian

Delta variant ‘descendant’ hits Israel – is it time to panic?

A new and potentially more transmittable version of the Delta variant has entered Israel just as the COVID infection rate has started to decline and the country prepares for flu season. Is the variant known as AY4.2 a reason to sound the alarms? According to the Health Ministry, a single case of AY4.2 was identified in Israel in an 11-year-old boy who recently returned from a trip to Moldova. The boy tested positive for coronavirus while in isolation, the ministry said, and so far, it does not appear that others were infected. However, with AY4.2 being as much as 10% to 15% more transmissible than its Delta grandparent, it is not unlikely that more cases are already in Israel and have just not yet been discovered, said Prof. Cyrille Cohen, head of the immunology lab at Bar-Ilan University.
24th Oct 2021 - The Jerusalem Post

South African Paediatric Association welcomes Covid-19 vaccines opening to young teens

To vaccinate or not? That is the question that parents of children from the age of 12 upwards are asking, now that the youngsters are eligible for Covid-19 jabs. Dr Joe Phaahla, the minister of health announced on Friday that children aged between 12 and 17, will be able to get the one dose of the Pfizer vaccine from Wednesday. He said the decision was taken following recommendations from the Ministerial Advisory Committee (MAC). “We believe that this will come in handy as the schools start their examinations, and for some that have already advanced towards concluding the academic year and studying to prepare for the next academic year,” he said. Those over the age of 18 get two shots of the Pfizer vaccine but the youngsters get a single jab as per recommendations from the South African Health Products Regulatory Authority (SAHPRA).
24th Oct 2021 - Independent Online

Pfizer jab 90% effective in kids

The Pfizer’s Covid-19 vaccine is more than 90 percent effective in preventing symptomatic disease among childen agred 5-to-11, the company said in a document released Friday, that put forward its case for authorisation. The new data was published on the website of the Food and Drug Administration, which has called an advisory panel of independent experts to meet Tuesday to vote on whether to green light the shot.
24th Oct 2021 - Bangalore Mirror

Vaccines alone will not end pandemic, warns WHO

The World Health Organization has warned that the vaccine alone will not be able to lift the world out of the pandemic. WHO Spokesperson Margaret Harris told Times Radio that the problem is focusing on one thing and that the vaccine isn't going to get us out of this. "We really have to do other measures," she said. Ms Harris said people "have got to be serious about not crowding". "We have still got to be looking at wearing the masks, when you're indoors particularly," she said. She added that the rest of the world must be vaccinated to stop new Covid variants from developing.
23rd Oct 2021 - RTE.ie

Here's Why Developing Countries Can Make mRNA Covid Vaccines

Across the developing world, hundreds of millions of people are unable to get a vaccine to protect themselves from the ravages of Covid-19, and millions of them have already become infected and died. Depending on wealthy nations to donate billions of doses is not working, public health experts say. The solution, many now believe, is for the countries to do something that the big American mRNA vaccine makers say is not feasible: Manufacture the gold-standard mRNA shots themselves.
23rd Oct 2021 - The New York Times

Why Some Healthcare Workers Would Rather Lose Their Jobs Than Get Vaccinated

The fact that these holdouts are healthcare workers makes them one of the most confounding challenges for the vaccination drive. Around one-third of the eligible population in the U.S. remains unvaccinated against Covid-19. Some of the vaccine holdouts, health officials believe, will ultimately be persuaded to get the shot—the so-called movable middle. Others might never be persuaded. Their resistance and potential influence threaten public-health efforts to defeat the virus, say epidemiologists and other health experts.
23rd Oct 2021 - The Wall Street Journal

FDA says benefits outweigh risks for Pfizer/BioNTech COVID-19 vaccine in children

Scientists at the U.S. Food and Drug Administration (FDA) said on Friday that the likely benefits of giving the Pfizer/BioNTech COVID-19 vaccine to 5 to 11 year olds clearly outweigh the risks of rare cases of heart inflammation. Earlier on Friday, the vaccine makers said their shot showed 90.7% efficacy against the coronavirus in a clinical trial of children 5 to 11 years old.
23rd Oct 2021 - Reuters

Sinovac added to S'pore national vaccination programme: 5 questions about the vaccine answered

The Sinovac Covid-19 vaccine will be included in the national vaccination programme to cater to individuals aged 18 years and above who are unable or unwilling to take the Pfizer-BioNTech or Moderna mRNA vaccines. The Ministry of Health said that three doses of the Sinovac vaccine will be required for a person to be considered fully vaccinated. The second dose should be taken 28 days after the first dose, while the third dose should be taken 90 days after the second dose.
23rd Oct 2021 - The Straits Times

Namibia to suspend use of Russian COVID-19 vaccine - ministry

Namibia will suspend its rollout of Russia's Sputnik V COVID-19 vaccine, its health ministry said on Saturday, days after the drugs regulator in neighbouring South Africa flagged concerns about its safety for people at risk of HIV. The Gamaleya Research Institute, which developed Sputnik V, said Namibia's decision was not based on any scientific evidence or research. South African regulator SAHPRA decided not to approve an emergency use application for Sputnik V for now because, it said, some studies suggested that administration of vaccines using the Adenovirus Type 5 vector - which Sputnik V does - was associated with higher susceptibility to HIV in men.
23rd Oct 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Oct 2021

View this newsletter in full

Pfizer-BioNTech Covid-19 Booster Shot Was 95.6% Effective in Large Trial, Companies Say

A third dose of the Covid-19 vaccine from Pfizer Inc.and BioNTech SE was found in a large study to be highly protective against symptomatic Covid-19, the companies said Thursday. Researchers found 109 cases of symptomatic Covid-19 among study subjects who received a placebo shot, compared with five cases in people who took the vaccine, resulting in 95.6% efficacy, the companies said. The additional dose was safe and tolerable, and consistent with what was known about the vaccine, the companies said. The study was carried out while the highly contagious Delta variant was prevalent, the companies said, suggesting the booster helps protect against the contagious strain.
22nd Oct 2021 - The Wall Street Journal

Pfizer vaccine 90% effective in warding off COVID in adolescents

The Pfizer vaccine is highly effective against preventing coronavirus in adolescents, a new Israeli study published overnight Wednesday in the New England Journal of Medicine showed. The research, which focused on youth between the ages of 12 and 18, was carried out by Clalit Health Services. It found that the vaccine was 90% effective against warding off infection and 93% effective against stopping symptomatic infection on days seven to 21 after the second dose, even against the Delta variant.
21st Oct 2021 - The Jerusalem Post

COVID vaccine makers brace for a variant worse than Delta

Pfizer’s chief executive, Albert Bourla, made a bold promise in June. Standing next to US President Joe Biden at a press conference in St Ives, UK, just before the G7 summit meeting, Bourla said that should the need arise for a new COVID-19 vaccine, his company could get one ready within 100 days. The need he was referring to is the possible emergence of an ‘escape variant’ — a dominant strain of SARS-CoV-2 that evades the fledgling immunity established through vaccines and previous infections. No such strain has yet been identified, but Pfizer and other leading COVID-19 vaccine makers are gearing up for that scenario. What does it take to be nimble enough to design and test an updated vaccine against an unknown viral strain, in record time? Nature spoke to three COVID-19 vaccine makers — Pfizer, Moderna and AstraZeneca — to find out exactly how they are preparing.
21st Oct 2021 - Nature

EU decision on Russia's Sputnik V shot 'impossible' this year - source

The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until at least the first quarter of 2022 because some data needed for the review is still missing, a source with knowledge of the matter said. "An EMA decision by the end of the year is now absolutely impossible," the source said, referring to the European Medicines Agency. If the required data is received by the end of November, "then the regulators may well decide in the first quarter of next year", he said.
21st Oct 2021 - Reuters

Schools should stay open as greatest risk of Covid transmission is in households, research finds

Despite Delta being more transmissible than earlier Covid-19 variants, in Australia few children and adolescents who get the virus have severe symptoms, and schools should only be closed under exceptional circumstances, a research analysis from the Murdoch Children’s Research Institute has found. However, the analysis reveals children and adolescents living with some pre-existing health conditions, including obesity, and those living in disadvantage, low socioeconomic communities or those with minority ethnic status have an increased risk of severe disease. The analysis also said ventilation is important and mental health surveillance is needed across both primary and secondary schools.
21st Oct 2021 - The Guardian

U.S. FDA clears Moderna, J&J COVID-19 boosters, backs use of different vaccine for boost

The U.S. Food and Drug Administration authorized booster doses of the COVID-19 vaccines from Moderna and Johnson & Johnson, and said Americans can choose a different shot from their original inoculation as a booster. That means all three vaccines authorized in the United States can also be given as boosters to some groups. "The availability of these authorized boosters is important for continued protection against COVID-19 disease," acting FDA Commissioner Janet Woodcock said in a statement. She noted that data suggests vaccine effectiveness may wane over time in some fully vaccinated people.
21st Oct 2021 - Reuters

Japan's Shionogi starts Phase II/III clinical trial for new COVID-19 vaccine

Japan' Shionogi & Co said it had started a Phase II/III clinical trial for its COVID-19 vaccine candidate. The trial for the recombinant protein-based vaccine will take place in Japan and follows a Phase I trial in the country, Shionogi said in a statement. The company will also prepare to conduct multiple trials globally, it said.
21st Oct 2021 - Reuters

UK adds nerve disorder as rare side-effect of AstraZeneca COVID-19 vaccine

The UK drug regulator added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), as a very rare side effect of the AstraZeneca COVID-19 vaccine, updates on the agency's website showed on Thursday. Medicines and Healthcare products Regulatory Agency's (MHRA) decision comes after the European medicines agency added GBS as a possible side-effect last month
21st Oct 2021 - Reuters

CDC Panel Endorses Moderna and J.&J. Boosters for Millions

In a sweeping victory for the Biden administration, the Centers for Disease Control and Prevention on Thursday endorsed booster shots of the Moderna and the Johnson & Johnson Covid-19 vaccines for tens of millions of Americans. The decision follows an agency endorsement last month of booster shots of the Pfizer-BioNTech vaccine and opens the door for many Americans to seek out a booster shot as early as Friday. The coronavirus vaccines “are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Rochelle Walensky, director of the C.D.C. said in a statement on Thursday night.
21st Oct 2021 - The New York Times

Pfizer-BioNTech report high efficacy of COVID boosters in study

Pfizer and its partner BioNTech have said data from a Phase III trial demonstrated high efficacy of a booster dose of their COVID-19 vaccine against the coronavirus, including the Delta variant. They said a trial of 10,000 participants aged 16 or older showed 95.6 percent effectiveness against the disease, during a period when the Delta strain was prevalent. The study also found that the booster shot had a favourable safety profile.
21st Oct 2021 - AlJazeera

Moderna, Johnson & Johnson COVID boosters nab FDA nods as agency backs 'mix-and-match' approach

The FDA has authorized a booster dose of Moderna's COVID-19 vaccine, allowing it to play catch up with the Pfizer-BioNTech shot, which scored a booster approval last month. The agency also blessed a second dose of the Johnson & Johnson vaccine. That nod applies to adults who have received one J&J shot two months prior. “The currently available data suggest waning immunity in some populations of fully vaccinated people,” FDA acting commissioner Janet Woodcock told reporters on Wednesday night. “The availability of these authorized boosters is important for continued protection against COVID-19.”
21st Oct 2021 - Fierce Pharma

Pfizer strong-armed governments in COVID-19 vaccine supply talks, report says

Pfizer is playing a leading role in producing vaccines against COVID-19, but new documents released by Public Citizen shine a light on the company's aggressive tactics when negotiating supply deals. In draft and final deals with the U.S., the U.K., Brazil and other countries, Pfizer retained rights to "silence" governments and "throttle supply" in an effort to "maximize profits" amid the world's "worst public health crisis in a century," Public Citizen concluded. For instance, in a deal with Brazil, Pfizer restricted the government from making “any public announcement concerning the existence, subject matter or terms of [the] Agreement” without a signoff from the drugmaker. Brazil also couldn't talk about the country's relationship with Pfizer without a signoff, Public Citizen said.
20th Oct 2021 - Fierce Pharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Oct 2021

View this newsletter in full

Gates Foundation to spend $120 mln to speed access to generics of Merck COVID-19 pill

The Bill & Melinda Gates Foundation said on Wednesday it would spend up to $120 million to kick-start development of generic versions of Merck & Co's (MRK.N) oral COVID-19 treatment to help ensure lower-income countries have equal access to the drug. The aim is to reduce the gap between when wealthy countries have access to the antiviral medicine, molnupiravir, and when the rest of the world can benefit from it. "To end this pandemic, we need to ensure that everyone, no matter where they live in the world, has access to life-saving health products," Melinda French Gates, co-chair of the Gates Foundation, said in a statement
20th Oct 2021 - Reuters

Poland to make COVID booster shots available to all adults

Poland is planning to make third doses of the coronavirus vaccine available to all adults "over the next few weeks", Prime Minister Mateusz Morawiecki said on Wednesday. "Those over 18 who had their last dose at least six months ago will be able to get another dose," Morawiecki said in a Facebook post. The country reported more than 5,000 daily new infections on Thursday for the first time since May amidst a surging fourth wave of the coronavirus pandemic.
20th Oct 2021 - Reuters

‘Vital’ at-home Covid pills could be given to vulnerable people this winter

Antiviral drugs that help to cut the risk of hospitalisation and death from Covid could be made available to vulnerable people this winter. It’s hoped the pills will be made available to the elderly and those with weakened immune systems who have recently tested positive for the virus or come into contact with an infected individual. Patients would take the drug at home, ideally before they fall ill. The antivirals, provided by Merck and Pfizer, have been secured in a government deal. But they will need to be approved for use by the UK’s medicines regulator before they are offered to patients via the NHS. Eddie Gray, chair of the antivirals taskforce, said the pills would help to support the NHS and the UK’s vaccination programme over the coming months, with infections and hospitalisations expected to further rise.
20th Oct 2021 - The Independent

Waning vaccine immunity helping drive up UK infections, suggesting herd immunity unreachable, say scientists

Waning immunity from vaccines is a key cause of rising infections – but it is not the only factor, scientists say. The number of new Covid infections recorded in the past week has increased by 16 per cent against a backdrop of falling immunity among those who received their second jab a few months or longer ago. A growing number of studies have found that immunity begins to fall within a few months, although jabs continue to provide good protection, especially from more severe cases.
20th Oct 2021 - iNews

South African regulator rejects Russia's COVID-19 vaccine

The South African drug regulator has rejected the Russia -made coronavirus vaccine Sputnik V, citing some safety concerns the manufacturer wasn't able to answer. The South African Health Products Regulatory Authority, or SAHPRA, said in a statement Tuesday that the request for Sputnik V to be authorized could “not be approved at this time,” referring to past failed HIV vaccines that used a similar technology. A late-stage study published in the journal Lancet last year in more than 20,000 participants found that Sputnik V was safe and about 91% effective in preventing people from becoming severely ill with COVID-19.
20th Oct 2021 - The Independent

Deaths among the double vaccinated: what is behind the Australian statistics?

On Tuesday, there were 356 Covid-19 patients being treated in intensive care wards throughout Australia. Of those, 25 were fully vaccinated. While the data points to the extraordinary efficacy of Covid-19 vaccines in preventing people from becoming severely unwell, being hospitalised and dying, it does raise the question: why do a small number of people become seriously ill and, in rare cases, die, despite being fully vaccinated? An intensive care unit staff specialist at Nepean hospital in Sydney, Dr Nhi Nguyen, said those who are fully vaccinated and die tend to have significant underlying health conditions. Being treated in intensive care, where people may be on a ventilator and unable to move, added to any existing frailty, especially in elderly people, she said.
20th Oct 2021 - The Guardian

Without Covid-19 jab, 'reinfection may occur every 16 months'

As Covid-19 infections surge in England, people are increasingly reporting catching Sars-CoV-2 for a second or even third time. New analysis has suggested that unvaccinated individuals should expect to be reinfected with Covid-19 every 16 months, on average. With winter approaching, scientists are warning that such reinfections could add to the burden on the NHS, some calling for the vaccination programme to be extended to all schoolchildren, including two doses for teenagers. “If you’ve got high-level prevalence, and frequent exposure to the virus, as you have in schools, you are going to see more and more people getting reinfected despite having been double vaccinated,” said Stephen Griffin, associate professor of virology at the University of Leeds.
20th Oct 2021 - The Guardian

Trials find no benefit of interferon, colchicine in COVID hospital patients

New clinical trials detail the failure of two COVID-19 treatments—a combination of interferon beta-1a and remdesivir and the drug colchicine—to reduce death by 28 days, length of hospital stay, or risk of requiring invasive mechanical ventilation or dying in hospitalized adults.
20th Oct 2021 - Scientific Viewpoint

Gates Foundation will provide $120 million to ensure generic production of Merck’s Covid-19 pill

As concern mounts over access to Covid-19 remedies, the Bill & Melinda Gates Foundation is committing up to $120 million to accelerate production of generic versions of an experimental Merck (MRK) pill to treat Covid-19 that would be available to dozens of low-income countries. But the effort was greeted with mixed reactions by patient advocates. The Gates Foundation plans to provide different types of incentives so that eight generic manufacturers, all of which have already signed voluntary licensing deals with Merck, will be positioned to produce a sufficient quantity of the drug, called molnupiravir, as quickly as possible. The goal is to convince the generic companies to ready their facilities rather than wait to gauge demand for the pill — which early data suggests could reduce hospitalizations and deaths — before ramping up.
20th Oct 2021 - STAT News

Sex of the fetus influences the mother’s response to Covid-19 infection, new research shows

In two studies published Tuesday in Science Translational Medicine, the Boston-based research teams found that pregnant and lactating women mount robust antibody responses to both vaccination and infection. The encouraging data also came with some twists that offer intriguing new clues to one of the pandemic’s enduring mysteries: why Covid-19 hits male adults, children, and infants harder than females. “What’s striking here is that the mothers who are carrying male babies have much lower levels of antibodies to the coronavirus,” said Akiko Iwasaki, a virologist and immunologist at Yale University who was not involved in the study. “What’s interesting about that is it means that the sex of the baby can dictate how the mother responds to a viral infection.”
20th Oct 2021 - STAT News

Covid Cases Are Soaring in Britain Again. Why?

Once again Britain has one of the highest rates of Covid infection anywhere. The U.K. just reported its biggest single day Covid case increase in three months and a 16% increase in confirmed cases in the week to Oct. 18. The government has warned of a bad winter. Even in the era of vaccines, the risks aren’t trivial. While deaths from Covid are now mercifully low, some of those who get infected will end up hospitalized. They will suffer, and occupy beds and health service resources that are already overstretched and coping with a gargantuan backlog of cases. Families will step in; productivity will be lost. Others will end up with Long Covid, whose symptoms last for weeks or months after the virus has cleared. High levels of infection will also increase the risk of new vaccine-resistant strains of the virus.
20th Oct 2021 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Oct 2021

View this newsletter in full

Pfizer/BioNTech COVID-19 vaccine highly protective in 12-18 age group - U.S. CDC study

The Pfizer Inc/BioNTech SE COVID-19 vaccine was 93% effective in preventing hospitalizations among those aged 12 to 18, according to an analysis released by the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday. The study was conducted between June and September, when the extremely contagious Delta variant of the coronavirus was predominant. Yet, the data from 19 pediatric hospitals showed that among the 179 patients who were hospitalized for COVID-19, 97% were unvaccinated, providing reassurance of the vaccine's efficacy.
19th Oct 2021 - Reuters

WHO defends delay in approving India’s Covaxin jab: ‘We are aware that many are waiting’

The World Health Organisation has defended its decision to delay the approval of India’s homemade coronavirus vaccine Covaxin and said that it cannot cut corners in its process. The international health body said that it was looking for “one additional piece of information” from Bharat Biotech, the Hyderabad-based company which created the vaccine. The vaccine, which was India’s first indigenously made Covid jab, is one of three currently being used in the country’s Covid-19 inoculation drive. India’s drugs control body had approved the restricted emergency use of Covaxin in January. It accounts for 11 per cent of the 980 million doses administered in the country so far.
19th Oct 2021 - The Independent

Oxford scientists working on new Covid vaccine to target Delta variant

A new and modified version of the Oxford vaccine is being developed to target the Delta coronavirus variant, The Independent understands. Early work has been started by members of Professor Dame Sarah Gilbert’s team at the University of Oxford – the same scientists behind the AstraZeneca jab first rolled out in January. A source told The Independent the new vaccine was being designed with the aim of “having something on the shelf ready to scale up – if it’s needed”. Although the UK’s vaccine programme was singled out as a success in a recent report which largely condemned the government for its handling of Covid-19, scientists have insisted there is still more to be done in better protecting the nation, with large pockets of the population and certain communities still not fully vaccinated.
19th Oct 2021 - The Independent

Atea plunges after COVID-19 treatment fails to help patients in study

Atea Pharmaceuticals Inc's experimental COVID-19 antiviral pill, being developed with Roche, failed to help patients with mild and moderate COVID-19 in a small study of mostly low-risk patients, driving the U.S. drugmaker's shares down more than 65% on Tuesday. The trial results puts Atea and Roche far behind U.S.-based Merck & Co Inc (MRK.N) in the race to a pill to treat COVID-19.
19th Oct 2021 - Reuters

Covid-19: New mutation of Delta variant under close watch in UK

Officials are keeping a close watch on a new descendant of the Delta variant of Covid that is causing a growing number of infections. Delta is the UK's dominant variant, but latest official data suggests 6% of Covid cases that have been genetically sequenced are of a new type. AY.4.2, which some are calling "Delta Plus", contains mutations that might give the virus survival advantages. Tests are under way to understand how much of a threat it may pose. Experts say it is unlikely to take off in a big way or escape current vaccines.
19th Oct 2021 - BBC News

US expected to authorize mix-and-match COVID booster shots

Federal regulators are expected to authorize the mixing and matching of COVID-19 booster doses this week in an effort to provide flexibility as the campaign for extra shots expands. The upcoming announcement by the Food and Drug Administration is likely to come along with authorization for boosters of the Moderna and Johnson & Johnson shots and follows the OK for a third dose for the Pfizer vaccine for many Americans last month. The move was previewed Tuesday by a U.S. health official familiar with the matter who was not authorized to speak publicly ahead of the announcement. The FDA was expected to say that using the same brand for a booster was still preferable, especially for the mRNA vaccines from Pfizer and Moderna that have proved most effective against the coronavirus. The agency was still finalizing guidance for the single-shot J&J vaccine.
19th Oct 2021 - The Associated Press

Does getting the flu with COVID double your risk of death?

Globally, an estimated 290,000 to 650,000 people typically die each year from seasonal flu. Last year, however, was different. The northern hemisphere winter of 2020-21 saw some of the lowest recorded flu death rates. Scientists believe this was mainly due to restrictions put in place at the height of the COVID-19 pandemic, most notably less mixing of people in indoor spaces, social distancing, mask wearing and hand washing. Many countries, including the United Kingdom, also saw record numbers of people come forward for the flu vaccine during this time – motivated in part by fears of contracting COVID and flu at the same time. The result was fewer flu cases, hospitalisations, and deaths compared with previous flu seasons. But as most of the developed world is now fully vaccinated against COVID, and governments are focused on reversing some of the economic damage of the pandemic, many social distancing measures have been lifted. In England alone, despite nearly 40,000 new cases of COVID per day, almost all protective measures to reduce the risk of transmission of the disease have been lifted.
19th Oct 2021 - The Guardian

Atea’s antiviral pill fails to clear Covid-19, forcing a re-think

Atea Pharmaceuticals said Tuesday that its antiviral pill for Covid-19 failed to combat the virus in a mid-stage trial, leading the company to delay its pivotal study by a year. The disappointing news follows a far more hopeful October update from Merck, whose similar antiviral reduced the chances that patients newly diagnosed with Covid-19 would be hospitalized by about 50% in a Phase 3 study. There is a desperate need for treatments for early Covid that can be taken as pills. Current treatments, such as remdesivir and monoclonal antibodies, are generally given intravenously or as injections, and are difficult to distribute to large numbers of people. The hope is that pills to treat Covid could be given widely in order to prevent infected people from progressing to severe disease, hospitalization, or death.
19th Oct 2021 - STAT News

Mix-and-Match Covid Boosters: Why They Just Might Work

Immunizations typically consist of two or more doses of the same vaccine. The Moderna vaccine, for example, is administered in two identical shots of mRNA, separated by four weeks. A double dose can create much more protection against a disease than a single shot. The first dose causes the immune system’s B cells to make antibodies against a pathogen. Other immune cells, called T cells, develop the ability to recognize and kill infected cells. The second shot amplifies that response. The B cells and T cells dedicated to fighting the virus multiply into much bigger numbers. They also develop more potent attackers against the enemy.
19th Oct 2021 - The New York Times

Why COVID boosters weren’t tweaked to better match variants

Pharma FDA delays decision on Moderna's COVID-19 vaccine in 12-17 age group because of myocarditis concerns: WSJ

After reports in four Nordic countries of the heart inflammation condition myocarditis, the FDA has delayed a decision on the Moderna COVID-19 shot for kids between the ages of 12 to 17, The Wall Street Journal reports. This month the shot was closing in on a nod, the newspaper reports, but now officials are taking a closer look at the vaccine's safety profile. The move comes after four countries—Denmark, Finland, Norway and Sweden—recommended against use of the Moderna shot by those under the age of 30. Some countries have said that young people should instead get the Pfizer vaccine. The concerns could lead the Pfizer shot to become the vaccine of choice for kids in that age group in the U.S. The company won FDA authorization for the 12 to 15 age group in May and has steered largely clear of myocarditis concerns in recent weeks. More than 12 million people ages 12 to 17 in the United States have received the Pfizer vaccine, according to the CDC.
18th Oct 2021 - FiercePharma

Pfizer, Moderna will rake in a combined $93 billion next year on COVID-19 vaccine sales: report

If you think Pfizer-BioNTech and Moderna are making a fortune on COVID-19 vaccine sales this year, just wait for 2022. The messenger RNA shot producers are projected to break the bank next year, generating combined sales of $93.2 billion, nearly twice the amount they are expected to rake in this year, says Airfinity. The health data analytics group puts total market sales for COVID-19 vaccines in 2022 at $124 billion, according to data seen by The Financial Times. Pfizer vaccine sales will reach $54.5 billion in 2022 and Moderna’s will hit $38.7 billion, Airfinity predicts. The estimates blow the consensus figures of $23.6 billion for Pfizer and $20 billion for Moderna out of the water.
18th Oct 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Oct 2021

View this newsletter in full

US to Consider Boosting J&J Vaccines With Pfizer or Moderna Shots, Fauci Says

President Joe Biden’s chief medical adviser said he expects U.S. regulators to consider whether people who got the one-dose Johnson & Johnson vaccine should get an mRNA shot against Covid-19 as a booster. “If you boost people who have originally received J&J with either Moderna or Pfizer, the level of antibodies that you induce in them is much higher than if you boost them with the original J&J,” Anthony Fauci said on ABC’s “This Week” on Sunday. “But the data of boosting the J&J first dose with a J&J second dose is based on clinical data,” he said. “So what’s going to happen is that the FDA is going to look at all those data, look at the comparison, and make a determination of what they will authorize.”
18th Oct 2021 - Bloomberg

U.K. Covid Surge Sparks Call for Probe Into Delta Plus Mutation

Former U.S. Food and Drug Administration Commissioner Scott Gottlieb called for “urgent research” into a mutation of the delta variant -- known as delta plus -- following a surge in Covid-19 cases in the U.K. “We need urgent research to figure out if this delta plus is more transmissible, has partial immune evasion,” Gottlieb said in a tweet. “There’s no clear indication that it’s considerably more transmissible, but we should work to more quickly characterize these and other new variants. We have the tools.”
18th Oct 2021 - Bloomberg

Covid-19 news: Valneva reports positive results from vaccine trial

A covid-19 vaccine made by Valneva produced stronger antibody responses and fewer side effects than the Oxford/AstraZeneca vaccine in a clinical trial, the French company has announced. The trial included more than 4600 participants in the UK, who were randomly allocated one of the two vaccines, while delta was the predominant coronavirus variant in circulation. The rate of covid-19 cases was similar in the two groups and no participants developed severe illness from covid-19. Valneva’s experimental vaccine, VLA2001, consists of inactivated whole virus particles, in combination with two adjuvants – drugs given to augment the immune response. “This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe and North America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic,” said Adam Finn at the University of Bristol, UK, chief investigator for the trial, in a press release.
18th Oct 2021 - New Scientist

Why COVID boosters weren't tweaked to better match variants

More COVID-19 booster shots may be on the way -- but when it’s your turn, you’ll get an extra dose of the original vaccine, not one updated to better match the extra-contagious delta variant. And that has some experts wondering if the booster campaign is a bit of a missed opportunity to target delta and its likely descendants. “Don’t we want to match the new strains that are most likely to circulate as closely as possible?” Dr. Cody Meissner of Tufts Medical Center, an adviser to the Food and Drug Administration, challenged Pfizer scientists recently. “I don’t quite understand why this is not delta because that’s what we’re facing right now,” fellow adviser Dr. Patrick Moore of the University of Pittsburgh said last week as government experts debated whether it’s time for Moderna boosters. He wondered if such a switch would be particularly useful to block mild infection.
18th Oct 2021 - The Associated Press

What Scientists Know About the Risk of Breakthrough Deaths

The death of former Secretary of State Colin L. Powell on Monday from complications of Covid-19 has provided fuel for vaccine skeptics and opponents, who immediately seized on the news that Mr. Powell had been vaccinated to stoke doubts about the effectiveness of the vaccines. But Mr. Powell’s immune system had most likely been weakened by multiple myeloma, a cancer of white blood cells. Both the disease and the treatment can make people more susceptible to infections. His age, 84, may also have increased his risk, scientists said. Mr. Powell received his second dose of the Pfizer-BioNTech vaccine in February, said Peggy Cifrino, his longtime aide. He had been scheduled for a booster last week but fell ill before he received it, she said.
18th Oct 2021 - The New York Times

Valneva reports positive results from Covid-19 vaccine trial

French pharmaceutical firm Valneva – whose UK contract for vaccines was cancelled last month – has reported positive results from its Covid-19 trial. Last month, the UK Government scrapped a deal for Valneva’s Covid-19 vaccine, with the firm saying the UK Government had served notice over allegations of a breach of the agreement, which Valneva “strenuously” denied. The UK had about 100 million doses on order and Prime Minister Boris Johnson visited Valneva’s Scottish manufacturing site in Livingston in January.
18th Oct 2021 - Belfast Telegraph

The WHO is letting down long Covid patients

It is unclear why the WHO definition snubs and does not embrace the term “long Covid”. The term was coined by patients who also refer to themselves as long-haulers. These patients-advocates-researchers galvanized attention around the existence of this disease and brought long Covid to the spotlight. In a short few months, they created a formidable patient-led advocacy and research movement that changed the arc of medical history. They were the first to survey their membership and catalogue the broad array of clinical problems caused by Covid-19. Their contributions will go down in the annals of history as an important inflection point.
18th Oct 2021 - The Guardian

South Africa regulator not authorising Russian COVID-19 vaccine for now

South Africa's drugs regulator said on Monday that it was not approving an emergency use application for Russia's Sputnik V COVID-19 shot for now, citing concerns about its safety for people at risk of HIV.
18th Oct 2021 - Reuters

WHO expects more information from India's Bharat Biotech for its COVID-19 vaccine

The World Health Organization on Monday asked for further data from India's Bharat Biotech to consider the company's request for an emergency-use listing for its COVID-19 shot, saying the WHO could not "cut corners" in making a decision. Bharat Biotech, which developed Covaxin with an Indian state research body, started sharing data with the WHO from early July. The vaccine was given emergency-use authorisation in India in January even before the completion of a late-stage trial, which later found the shot to be 78% efficacious.
18th Oct 2021 - Reuters

Doctor who advocated Covid-19 therapy including ivermectin applied for patent on same unproven treatment

A Sydney gastroenterologist who has been enthusiastically promoting an unapproved Covid-19 treatment, including to Australian politicians and general practitioners, has filed a patent in the US for the same treatment, allowing him to commercialise and profit from it, if approved. Prof Thomas Borody has been quoted in medical newsletters and publications, and in news outlets including the Financial Review, the Daily Telegraph and the Australian, promoting what he describes as a “triple therapy protocol” to treat and cure Covid-19. The protocol involves a combination of the anti-parasitic drug ivermectin, zinc and the antibiotic doxycycline. In December 2020 Borody filed a patent in the US for therapeutic combinations of drugs, including a combination of ivermectin, an antibiotic and zinc. Patenting a treatment means the owner of the patent is allowed to exclusively manufacture, market and profit from the drug until the patent expires, usually after 20 years.
18th Oct 2021 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Oct 2021

View this newsletter in full

CDC data: Unvaccinated 11 times more likely to die from COVID-19 than fully vaccinated | TheHill

Unvaccinated people have an 11 times higher risk of dying from COVID-19 than fully vaccinated people, according to new data posted by the Centers for Disease Control and Prevention (CDC). The data run through August and are from 16 health departments representing about 30 percent of the U.S. population, the CDC said. In addition, the data show that unvaccinated people have a six times higher chance of testing positive for COVID-19 than fully vaccinated people do.
17th Oct 2021 - The Hill

Will New Covid Treatments Be as Elusive for Poor Countries as Vaccines?

Nearly a year after the first Covid-19 vaccination campaigns began, the vast majority of the shots have gone to people in wealthy nations, with no clear path toward resolving the disparity. News this month that an antiviral medication had proved effective against the coronavirus in a large clinical trial has brought new hope of a turning point in the pandemic: a not-too-distant future when a simple pill could keep infected people from dying or falling severely ill. The drug, molnupiravir, made by Merck, is easy to distribute and can be taken at home. The trial results showed it halved the risk of hospitalization and death among high-risk people early in their infections.
17th Oct 2021 - The New York Times

Studies show that mask-wearing reduces Covid-19 outbreaks in schools

New studies by the Centers for Disease Control and Prevention (CDC) show that US counties with masking policies in place in their schools have a lower risk of Covid-19 outbreaks compared to counties that do not have masking policies. The United States-based research assessed the impact of masking in schools on new Covid-19 cases in learners from kindergarten to grade 12 across the country. The CDC examined the difference between paediatric Covid-19 case rates in schools with and without school mask requirements. The researchers used data from 1 July to 4 September 2021. The researchers developed inclusion criteria that the schools had to meet to be part of the study. This included a valid school start date in districts with known school mask requirements, a uniform mask requirement for all learners and at least three weeks with seven full days of case data after the beginning of the school year.
16th Oct 2021 - News24

South Africa just hit 20 million vaccinations. Here is how that compares globally.

On Friday, South Africa reached 20 million administered doses of Covid-19 vaccine. Somewhat over a quarter of the adult population is fully vaccinated for the coronavirus. Globally, more than 6.6 billion doses have now been administered, and the proportion of the world population fully vaccinated is fast approaching 40%.
16th Oct 2021 - Business Insider South Africa

Slightly more than half of migrant workers in Jurong dorm vaccinated or have verified status, says MOM

Fifty-five per cent of the migrant workers at Westlite Jalan Tukang dormitory have verified their vaccination status or have been vaccinated against COVID-19 as of Saturday (Oct 16), the Ministry of Manpower (MOM) said. The remaining 45 per cent are pending verification or have yet to receive a Pandemic Special Access Route (PSAR) or World Health Organization Emergency Use Listing Procedure (WHO EUL) vaccine, said MOM in a statement on Saturday. The two PSAR-approved vaccines are the ones made by Pfizer-BioNTech and Moderna. These are also among the WHO EUL vaccines, which include AstraZeneca, Johnson & Johnson, Sinopharm, Sinovac and Covishield.
16th Oct 2021 - CNA

Songkhla adopts stricter Covid screening

Authorities in Songkhla have toughened screening measures in areas adjacent to the three southernmost border provinces in hopes of bringing down stubbornly high rates of Covid-19 infections. People travelling from Pattani, Yala and Narathiwat will have to show proof of coronavirus vaccination, negative test results or other documents if they wish to enter Songkhla, governor Jetsada Jittarat said on Saturday. Songkhla on Saturday reported 621 new coronavirus cases, the third highest in the country behind Bangkok (1,077) and Yala (664). The new infections raised the cumulative provincial total to 39,296, with deaths at 171. The number of daily infections in Songkhla has been between 400 and 600 a day, which is partially a reflection of high levels of mass testing by health workers in many areas.
16th Oct 2021 - Bangkok Post

Second J&J COVID shot gets expert backing; FDA looking at lowering age for Pfizer booster

Outside advisers to the U.S. Food and Drug Administration on Friday unanimously recommended the agency authorize a second shot of Johnson & Johnson's COVID-19 vaccine for all recipients of the one-dose inoculation. The agency is also considering lowering the recommended age for booster shots of the Pfizer/BioNTech vaccine to people as young as 40, FDA official Dr. Peter Marks told the advisory panel. The FDA's Vaccines and Related Biological Products Advisory Committee backed the shots for all J&J recipients aged 18 and older at least two months after their first dose.
15th Oct 2021 - Reuters

New fungus stalks Covid-recovered

After mucormycosis (black fungus), another fungal infection has been detected in four Covid-recovered patients in Pune in the last three months, raising concerns among the health fraternity. Prabhakar* (66) complained of mild fever and severe lower back pain a month after recovering from COVID-19. He was initially treated conservatively with muscle relaxants and non-steroidal anti-inflammatory drugs without relief. An MRI scan revealed severe infection-led bone damage to the spinal disc spaces called spondylodiscitis. A bone biopsy and culture grew aspergillus species — a type of mold (fungus).
15th Oct 2021 - Times of India

90,000 US Covid deaths could have been prevented by vaccines in 4 months, 2 leading nonprofits estimate

About 90,000 Covid-19 deaths in the US between June and September were preventable, two US nonprofits say. In September, 49,000 deaths could have been avoided if more adults got a Covid-19 shot, they said. The Kaiser Family Foundation and the Peterson Center on Healthcare cited a tracker that uses CDC data.
14th Oct 2021 - Business Insider South Africa

Expert panel recommends approving Covaxin for kids

The central drug regulator’s expert panel has recommended granting marketing authorisation with certain conditions to Bharat Biotech's Covaxin for restricted emergency use in children and adolescents in the age group of 2 to 18 years old.
13th Oct 2021 - Times of India

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Oct 2021

View this newsletter in full

Moderna Booster Shot Backed by FDA Advisory Panel

Vaccine experts advising the Food and Drug Administration voted 19 to 0 Thursday to recommend authorization of an extra dose of Moderna Inc.’s MRNA 3.23% Covid-19 shot, a key step in making booster doses available to millions more people. A vaccine-advisory panel voted in favor of giving a Moderna booster shot at least six months after the second dose, to adults 65 years and older, as well as adults under 65 who are at high risk of severe Covid-19 or serious complications because of their jobs, living conditions or underlying medical conditions.
14th Oct 2021 - The Wall Street Journal

FDA Panel Backs Moderna Booster for Older, High-Risk People

Booster shots of Moderna Inc.’s Covid-19 vaccine should be given to older people and those at high risk of the disease, advisers to U.S. regulators said. Additional doses of the two-shot messenger RNA vaccine should be offered to people 65 and older, along with adults 18 and older who are at high risk for medical or occupational reasons, the Food and Drug Administration’s vaccine advisory panel said Thursday in a unanimous, 19-0 vote. The booster, which is half the original dose, should be given at least six months after the initial inoculation, the panel said. Moderna shares gained as much as 4.9% in Thursday afternoon trading in New York.
14th Oct 2021 - Bloomberg

FDA advisers back Moderna COVID-19 booster shots for older and high-risk people

A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Thursday to recommend booster shots of Moderna's COVID-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus. If the FDA signs off on Moderna's booster, the U.S. Centers for Disease Control and Prevention will make specific recommendations on who should get the shots. CDC advisers are scheduled to meet next week.
14th Oct 2021 - Reuters

FDA vaccine advisers are meeting to consider Moderna Covid-19 vaccine boosters

Vaccine advisers to the US Food and Drug Administration voted unanimously Thursday to recommend emergency use authorization of a booster dose of Moderna's Covid-19 vaccine. The FDA's Vaccines and Related Biological Products Advisory Committee agreed use of a booster dose would be safe and effective in some people six months out from their primary series. But some were clearly reluctant. Moderna had asked for emergency use authorization for a half dose of its vaccine to be used as a booster for certain people.
14th Oct 2021 - CNN

Hungary will receive technology to produce Sputnik V COVID-19 vaccine -foreign minister

Hungary will receive technology this year to produce Russia's Sputnik V COVID-19 vaccine at a Hungarian plant currently under construction, Foreign Minister Peter Szijjarto said in Moscow on Thursday according to a foreign ministry statement. This would be the first concrete step towards making the vaccine in the European Union, even though it is not yet approved in the bloc. The Sputnik V vaccine, widely used in Russia and approved for use in more than 70 countries, is still undergoing a review by the World Health Organization (WHO) and the European Medicines Agency.
14th Oct 2021 - Reuters

J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study

People who got Johnson & Johnson Inc’s COVID-19 vaccine as a first shot had a stronger immune response when boosted with vaccines from Pfizer Inc/BioNTech SE or Moderna Inc, a study run by the National Institutes of Health showed on Wednesday. The study, which is preliminary and hasn't been peer reviewed, is the latest challenge to J&J's efforts to use its COVID-19 vaccine as a booster in the United States. The study, which included more than 450 adults who received initial shots from Pfizer, Moderna, or Johnson & Johnson, showed that "mixing and matching" booster shots of different types is safe in adults. Moderna's and Pfizer's vaccines are based on messenger RNA while J&J's uses viral vector technology.
14th Oct 2021 - Reuters

EU starts real-time review of AstraZeneca COVID-19 antibody cocktail

Europe's drug regulator said on Thursday it had started a real-time review of AstraZeneca's antibody-based COVID-19 therapy, the first protective shot other than vaccines against coronavirus. The decision by the human medicines committee of the European Medicines Agency (EMA) to begin the rolling review was based on early results from clinical studies, the regulator said. It did not say when a conclusion was expected. The move to start a real-time review, so called because data is evaluated as it is made available, came roughly a week after the Anglo-Swedish drugmaker sought emergency approval from U.S. authorities.
14th Oct 2021 - Reuters

COVID-19: New WHO team may be 'last chance' to understand origins of coronavirus

A newly formed World Health Organisation (WHO) team may be "our last chance" to understand the origins of coronavirus, the body's top emergency expert has said. The WHO has named 26 proposed members of its Scientific Advisory Group on the Origins of Novel Pathogens (SAGO), to determine the origins of coronavirus. Maria Van Kerkhove, WHO technical lead on COVID-19, said she hoped there would be further WHO-led international missions to China to encourage the country to cooperate.
14th Oct 2021 - Sky News

What’s the latest advice on the type of mask I should wear?

What’s the latest advice on the type of mask I should wear? It depends on your situation, but health officials say it should cover your nose and mouth, and fit snugly so there aren’t any gaps on the sides of your face. The U.S. Centers for Disease Control and Prevention also says to pick masks with two or more layers and a nose wire to prevent air from leaking out the top. It suggests holding your mask up to check if it blocks light, which means the fabric will probably filter out more particles. If you want added protection, experts also suggest wearing two masks or pairing them with a mask fitter to ensure they don’t leave any gaps.
14th Oct 2021 - Reuters

China warns against ‘manipulation’ of WHO virus probe

China’s Foreign Ministry on Thursday warned against what it called possible “political manipulation” of a renewed probe by the World Health Organization into the origins of the coronavirus, while saying it would support the international body’s efforts. The WHO on Wednesday released a proposed list of 25 experts to advise it on next steps in the search for the virus’ origins after its earlier efforts were attacked for going too easy on China, where the first human cases were detected in late 2019. Beijing was accused of withholding raw data on early cases during a visit by a WHO team in February and has since resisted calls for further investigation, saying the U.S. and others were politicizing the matter.
14th Oct 2021 - The Associated Press

COMMENTARY: What can masks do? Part 1: The science behind COVID-19 protection

Confusion continues to abound over the effectiveness of masks to protect people from COVID-19, and recent news stories touting imperfect studies are only compounding the situation. First, there was confusion and then intransigence about the modes of transmission, with the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) insisting for many months after SARS-CoV-2 emerged that the virus was transmitted only by large droplets or hand contact. Only fairly recently did those agencies finally recognize that inhalation of small infectious particles in the air ("aerosols") is a more important mode of transmission. That was followed by substantial misinformation and misunderstanding about the role of cloth face coverings, surgical masks, and respirators in preventing SARS-CoV-2 spread. Then we had misunderstandings and poor messaging about the efficacy of different interventions, the effectiveness of one intervention versus another, and why interventions should be considered in a particular order or hierarchy.
14th Oct 2021 - CIDRAP

The hidden cost of Covid-19: years of life lost among the young

Body counts appear to support the common perception that Covid-19 does its worst damage among the old and vulnerable. But body counts mask another reality, and focusing on them is skewing policy decisions and individual choices. There’s no question that deaths were most common among old and vulnerable individuals early in the pandemic. Some politicians and academics have used death rates to conclude that the pandemic’s toll has been largely confined to the elderly and sick, and that widespread mitigation measures such as mask and vaccine mandates are unjustified. We looked at Covid-related deaths through a different lens — years of life lost — which revealed a very different picture about the burden of illness than deaths alone.
14th Oct 2021 - CIDRAP

Tracking the FDA advisory panel meeting on Moderna’s Covid vaccine booster

With people who received the Pfizer-BioNTech Covid-19 vaccine already in the process of getting booster shots, attention is shifting this week to what to do with people who received one of the two other vaccines in use in the U.S., the two-dose Moderna vaccine and the one-shot Johnson & Johnson product. Members of the Food and Drug Administration’s vaccine expert panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), are meeting today to discuss Moderna’s application for a booster shot for its product and again Friday to discuss the J&J application. The Biden administration has made it clear that it wants to boost all Americans who have been vaccinated, suggesting they should receive an additional jab six months or later after the last dose in their original vaccine regimen. Though the World Health Organization has asked wealthy countries to hold off on using boosters to make more vaccine available to low-income countries, and some experts have argued most people don’t currently need boosters, the administration has been unswerving on this policy.
14th Oct 2021 - STAT News

WHO says approval for Russia’s Sputnik V vaccine ‘still on hold’

The World Health Organization has said the Emergency Use Listing process for Russia’s Sputnik V COVID-19 vaccine was on hold pending some missing data and legal procedures, which the UN body hopes will be “sorted out quite soon”. “We are working almost on a daily basis with the ministry of health in Russia to address the remaining issues to be fulfilled by the Russian Direct Investment Fund,” Mariangela Simao, WHO assistant director-general for access to medicines and health products, said on Wednesday. Simao said that as soon as an agreement was reached, the WHO will reopen the case and assess data that was submitted, even though it was “still incomplete” and resume manufacturing site inspections in Russia. “All submissions that we have, they are addressed the same way,” she said and did not specify a timeline for when the listing process could be completed.
13th Oct 2021 - AlJazeera

Most COVID-19 survivors have symptoms 6 months on, review finds

A systematic review of 57 studies involving more than 250,000 COVID-19 survivors reveals that 54% still had at least one symptom 6 months or more after initial diagnosis or release from the hospital. In the review, published today in JAMA Network Open, a team led by Hershey (Pennsylvania) Medical Center researchers searched the literature from December 2019 through March 2021 for studies on persistent COVID-19–related symptoms diagnosed using lab results, radiologic findings, or clinical signs or symptoms at or after 1 month.
13th Oct 2021 - CIDRAP

Moderna criticized for COVID-19 vaccine strategy putting once feel-good success story in jeopardy

Since it was approved 10 months ago, the Moderna COVID-19 vaccine has enjoyed a relatively unfettered run on its way to being considered one of the world’s two elite shots. But while COVID vaccine rival and pharmaceutical goliath Pfizer has faced a demanding spotlight, biotech Moderna has skipped along under the radar, avoiding scrutiny and gaining favor as a feel-good, success story. But that’s starting to change. With evidence mounting that other vaccine producers have made their shots more readily available to poorer countries, the shine is wearing off the Boston-based company. And with Tuesday’s revelation to the Associated Press that Moderna has no intention of sharing its mRNA vaccine formula with the rest of the world, the company has taken another public relations hit.
13th Oct 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Oct 2021

View this newsletter in full

J. & J. Recipients May Be Helped More by Other Brands’ Booster, Study Says

People who received a Johnson & Johnson coronavirus vaccine may be better off with a booster shot from Moderna or Pfizer-BioNTech, according to preliminary data from a federal clinical trial published on Wednesday. That finding, along with a mixed review of Johnson & Johnson’s booster data from the Food and Drug Administration released earlier in the day, could lead to a heated debate about whether and how to offer additional shots to the 15 million Americans who have received the single-dose vaccine. The agency’s panel of vaccine advisers will meet on Friday and vote on whether to recommend that the agency authorize the company’s application for boosters for recipients of its vaccine.
13th Oct 2021 - The New York Times

Covid-19 Vaccine Effects on Death Rates Differ by Country, Why?

It’s one of the great puzzles of the pandemic. Most developed economies are now highly vaccinated with some of the most effective shots on offer, so why are the latest Covid-19 outbreaks more deadly in some places than in others? While it’s clear vaccines led to a drop in fatalities during the most recent delta variant-driven waves compared with earlier bouts with the virus, some countries saw deaths fall to a greater degree than others, an outcome scientists still don’t have answers for. Countries like Germany, Denmark and the U.K. have seen Covid deaths fall to roughly a tenth of previous peaks, according to Bloomberg calculations using data compiled by Johns Hopkins University. In Israel, Greece and the U.S., fatalities fell but remained more than half of the previous peaks.
13th Oct 2021 - Bloomberg

Fifth death in Scotland due to Covid-19 vaccine complications is recorded

A further person has died in Scotland due to underlying adverse effects from the Covid-19 vaccine. The National Records of Scotland has confirmed that the fifth person in the country has now died as a result of complications stemming from receiving the jab. The statistics also show that 4.2 million people had been given the first dose of the vaccine as of September 30. A total of 11,262 have now died from the virus in Scotland, it added. The latest data shows that during the week of October 4-10, 126 registered fatalities included the cause was Covid-19 on their death certificate, a decrease of 17 on the previous week.
13th Oct 2021 - Edinburgh Live

Do COVID vaccines prevent transmission of the virus?

But do vaccines actually limit the spread of the virus? A large study, not yet peer-reviewed, led by a team at Oxford University and looking specifically at the Delta variant has shown that both the Pfizer and AstraZeneca vaccines do indeed reduce transmission of the disease. The study looked at almost 150,000 contacts who were traced from nearly 100,000 initial cases of COVID. The initial COVID-positive cases contained a mix of vaccinated and unvaccinated people and the aim was not only to see which groups were most likely to pass on the virus, but also which of the Pfizer or AstraZeneca vaccines were most effective in reducing transmission.
13th Oct 2021 - Al Jazeera English

BRIEF—Russia recommends RA drug olokizumab for COVID-19 of any severity

The Russian Ministry of Health has issued the 12th version of the Temporary guidelines for the prevention, diagnosis and treatment of COVID-19. This time the expert analysis resulted in a significant expansion of olokizumab usage in clinical practice. Olokizumab is the first in Russia novel genetically engineered biological drug developed by R-Pharm, one of the country’s leading biotechs. In the new document, olokizumab is additionally included in treatment regimens for mild and critical COVID-19 patients in hospital setting.
13th Oct 2021 - The Pharma Letter

Russia to test COVID-19 vaccine in form of nasal spray

Russia will test a nasal spray form of its Sputnik V vaccine against COVID-19 among adult volunteers, according to a state document published on Tuesday, as the country struggles to rein in rising numbers of infections and deaths. read more Russia was quick to develop and launch its Sputnik vaccine when the coronavirus pandemic struck last year, but take-up has been slow, with many Russians citing distrust of the authorities and fear of new medical products. The nasal spray is to be applied in two doses in a clinic in St Petersburg, according to the document published on the state register of medicines, which did not provide the planned timing of the clinical tests.
13th Oct 2021 - Reuters

China to test thousands of Wuhan blood samples in Covid-19 probe

China is preparing to test tens of thousands of blood bank samples from the city of Wuhan as part of a probe into the origins of Covid-19, according to a Chinese official. The move comes amid increasing calls for transparency over the emergence of the virus. The store of up to 200,000 samples, including those from the closing months of 2019 were pinpointed in February this year by the World Health Organization's panel of investigators as a possible source of key information that could help determine when and where the virus first crossed into humans. The samples are kept in the Wuhan Blood Center, and are thought to span 2019, providing real-time tissue samples from a wide swathe of the population in the Chinese city where SARS-CoV-2 is thought to have first infected humans.
13th Oct 2021 - CNN

Panama approves Pfizer COVID-19 booster for high-risk people

Panama has approved a booster dose of Pfizer Inc's (PFE.N) COVID-19 vaccine for high-risk people, including healthcare workers, bedridden patients, nursing home residents and people over 55, health officials said on Tuesday. The Central American country has reported 469,440 COVID-19 infections since the start of the pandemic and 7,275 deaths. More than 5.5 million vaccine doses have been administered since January, covering most of the eligible population. "We have decided to begin the process of applying a booster shot to the population with the Pfizer vaccine, starting tomorrow in public and private hospitals," Health Minister Luis Sucre said.
13th Oct 2021 - Reuters

FDA says Moderna does not meet all criteria for Covid-19 boosters

Scientists at the US Food and Drug Administration said that Moderna has not met all of the agency’s criteria to support use of booster doses of its Covid-19 vaccine, possibly because the efficacy of the shot’s first two doses has remained strong. FDA staff said in documents that data for Moderna’s vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high. The documents were released on Tuesday ahead of a meeting later this week of the FDA’s outside expert advisers to discuss booster doses of the vaccine.
13th Oct 2021 - The Independent

Watch: Merck’s Covid pill could transform treatment. Here’s how it works

Earlier this month, study results showed that molnupiravir, Merck’s investigational antiviral pill, cut hospitalization rates of Covid-19 patients by about half. Molnupiravir is the first oral treatment that has shown promise in treating Covid-19. Another antiviral, remdesivir, can only be administered intravenously. “Having an oral option will be a big change,” said Benjamin Gewurz, associate director of the Ph.D. program in virology at Harvard Medical School. “Some people could just take a pill rather than having an IV or injection of some sort. And that’s what would be a huge, huge advance.”
13th Oct 2021 - Stat News

WHO advisers recommend 3rd COVID vaccine dose for highest-risk groups

The group, called the Strategic Advisory Group of Experts (SAGE), said people in the immunocompromised groups should be offered an additional dose in the vaccine series, since they are less likely to respond adequately to vaccination with the standard series and are at high risk for severe disease. WHO leaders have previously urged countries to postpone broader use of booster doses to free up more vaccine for countries that had much less access to supplies. SAGE said its third-dose recommendation applies to all vaccines that the WHO has approved for emergency use. They include Pfizer-BioNTech, AstraZeneca-Oxford, Johnson & Johnson, Moderna, Sinopharm, and Sinovac. For Sinopharm and Sinovac, two inactivated vaccines from China, SAGE said a third dose should be offered to people ages 60 and older as part of an extended primary series. It added that a third dose of a different vaccine could be considered, based on vaccine supply and access. However, SAGE urged countries to prioritize 2-dose coverage in that age group, then administer third doses, starting with the oldest age groups.
12th Oct 2021 - CIDRAP

FDA scientists neutral on Moderna Covid-19 vaccine booster ahead of key meeting

Food and Drug Administration scientists did not take a clear position as to whether the agency should authorize booster doses of the Moderna Covid-19 vaccine in documents released Tuesday. Posted ahead of a two-day meeting convened by the FDA on booster shots of both the Moderna and Johnson & Johnson vaccines, the documents laid out the case for authorizing Moderna’s proposed booster — a half dose of the existing vaccine — but also noted that data so far make it unclear that the third dose is needed. “Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not,” FDA scientists wrote in a briefing document. However, they wrote, current data suggest that Covid vaccines that are available in the U.S. still protect against severe Covid-19 disease and death.
12th Oct 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Oct 2021

View this newsletter in full

FDA Staff Don’t Take Position on Moderna Covid-19 Booster

Food and Drug Administration staffers didn’t take a firm stance on Moderna Inc.’s application for a booster dose, indicating there may not be sufficient data to support the extra dose. FDA staff, after reviewing a drugmaker’s application, often weigh whether it should be given a go-ahead. But they also didn’t take a position on Pfizer Inc.’s booster request, later granted. FDA staff reviews are part of the normal process before the agency makes a decision whether to clear a product. In documents made public Tuesday, FDA staff simply restated Moderna’s request and analyzed Moderna’s study data. The extra dose of Moderna’s vaccine appeared to be safe and work well, but the staff said its benefit would depend on how much the protection from the primary series has waned.
12th Oct 2021 - The Wall Street Journal

Moderna Argues to FDA for Half-Dose of Vaccine as Booster

In documents released Tuesday morning, Moderna argued that the Food and Drug Administration should authorize a half-dose of its coronavirus vaccine as a booster shot for recipients at least six months after the second dose, citing evidence that the vaccine’s potency against infection wanes over time. The agency noted in its own analysis that, overall, available data show Moderna and the other vaccines “still afford protection against severe Covid-19 disease and death in the United States.” Moderna cited the rate of breakthrough infections, “real world evidence of reduced effectiveness against the Delta variant,” and falling levels of neutralizing antibodies from its vaccine six to eight months after a second dose. The company said its clinical trial studies showed that a third injection boosted antibody levels — one measure of the immune system’s response — higher than what they had been before the second dose.
12th Oct 2021 - The New York Times

Rapid Covid Tests Can Beat Pandemic: Harvard's Michael Mina

The 37-year-old epidemiologist, immunologist, and physician says it didn’t have to be this way: Workplaces, schools, event spaces, and more that have been desolate for better than a year could have stayed open—and safely—with a technology that’s been here all along. Mina has been an early and tireless champion of inexpensive, do-it-yourself SARS-CoV-2 antigen tests that can return a positive or negative result in about 15 minutes, arguing for their wider deployment in op-ed articles, on Twitter, and in conversations with health authorities.
12th Oct 2021 - Bloomberg

CureVac drops COVID-19 vaccine, pins hope on next-generation shots

CureVac NV said on Tuesday it will give up on its first-generation COVID-19 vaccine candidate and instead focus on collaborating with GSK to develop improved mRNA vaccine technology. The German biotechnology company's shares were off about 8% after earlier plunging as much as 13%, hitting their lowest since going public in August last year. CureVac said it would abandon its application for approval from the European Medicines Agency for its first COVID-19 vaccine candidate, CVnCoV, after late-stage trials delivered disappointing results in June with 47% efficacy.
12th Oct 2021 - Reuters

Moderna, J&J push for COVID-19 vaccine boosters ahead of FDA meeting

Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong. FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.
12th Oct 2021 - Reuters

Covid study linking vaccines to rare side effect of myocarditis was wrong, researchers admit

A research study that linked a very rare side effect to the Covid-19 mRNA vaccines has been withdrawn by researchers after they made a major mathematical error. The Canadian study attracted headlines after it suggested there was a 1 in 1,000 risk of people developing myocarditis or inflammation of the heart after receiving the Moderna or Pfizer/BioNTech vaccines. But the paper’s conclusions were wrong, and the calculation flawed. The numbers used by the researchers, from the Ottawa Heart Institute, underestimated the amount of vaccines delivered in Ottawa over a two-month period with the result being 25 times smaller than the true figure. They had initially based their estimate on a total of 32,379 vaccines doses and 32 cases of myocarditis, when in reality more than 854,000 doses had been given between June 1 to July 31. The study’s findings have been used by anti-vaccination websites and social media accounts in Britain, the United States and Canada.
12th Oct 2021 - The Independent

AZ’s long-acting antibody combo shows benefit in COVID-19 trial

AstraZeneca has announced positive results from a Phase III trial evaluating its long-acting antibody (LAAB) combination AZD7442 in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. In the Phase III TACKLE trial, a total of 90% of participants enrolled were from populations with a high-risk of progressing to severe COVID-19, including individuals with co-morbidities. The late-stage trial hit its primary endpoint, with AZD7442 600 mg given by intramuscular injections (IM) reducing the risk of developing severe COVID-19 or death from any cause by 50% compared to placebo in outpatients who had been symptomatic for seven days or less.
12th Oct 2021 - PharmaTimes

AstraZeneca's long-acting antibody combination treats and prevents COVID-19

Positive high-level results from the TACKLE Phase III COVID-19 treatment trial have shown that AstraZeneca’s AZD7442, a long-acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. On 5 October 2021, the company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19. A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.
12th Oct 2021 - Pharmafield

Merck aims to double supply of Covid-19 antiviral pill on rising demand

Merck plans to double manufacturing capacity for its antiviral pill to treat Covid-19 next year as governments scramble to procure a treatment that a late-stage trial showed cuts hospital admission and death rates in half. The mounting demand for Merck’s drug, the first oral treatment shown to prevent severe disease in vulnerable people with coronavirus, is a sign that it could trigger the same kind of worldwide rush faced by makers of early Covid-19 vaccines. Merck, which this week asked US regulators to authorise use of the drug called molnupiravir, told the Financial Times it had secured deals with Singapore, New Zealand, Australia and South Korea to supply doses in the past week and is in talks with several other governments.
12th Oct 2021 - Financial Times

A primer on what we know about mixing and matching Covid vaccines

Later this week an expert committee that advises the Centers for Disease Control and Prevention will hear about the results of a clinical trial that could influence how Covid vaccines are used in this country at some point in the future. The trial, conducted by the National Institute of Allergy and Infectious Diseases, is a so-called mix-and-match trial, testing the Covid vaccines authorized in the U.S. in combinations with each other. The goal of the trial was to see whether using a different vaccine as a booster shot improves protection. So does getting a dose of Pfizer vaccine after getting a single dose of Johnson & Johnson’s vaccine trigger production of more antibodies than a second dose of the J&J would? Are the messenger RNA vaccines made by Pfizer and Moderna virtually interchangeable, or does switching even there produce a broader set of immune responses?
12th Oct 2021 - Stat News

COVID infects all ages in family equally, but immunity plays a role

Two new studies explore the risk of SARS-CoV-2 transmission among household members, one finding that children and adults are at similar risk and one showing that COVID-19–naïve family members' risk was 45% to 97% lower, depending on the number of members immune through infection or full vaccination.
11th Oct 2021 - Scientific Viewpoint

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Oct 2021

View this newsletter in full

French study of over 22m people finds vaccines cut severe Covid risk by 90%

Vaccination reduces the risk of dying or being hospitalised with Covid-19 by 90%, a French study of 22.6 million people over the age of 50 has found. The research published on Monday also found that vaccines appear to protect against the worst effects of the most prevalent virus strain, the Delta variant. “This means that those who are vaccinated are nine times less at risk of being hospitalised or dying from Covid-19 than those who have not been vaccinated,” the epidemiologist Mahmoud Zureik, who oversaw the research, told Agence France-Presse. The study – the largest of its kind so far – was carried out by Epi-Phare a scientific group set up by France’s health system, its national health insurance fund, l’Assurance Maladie (CNAM), and the country’s ANSM medicines agency.
11th Oct 2021 - The Guardian

AstraZeneca antibody cocktail trials show it can halve risk of severe disease, prevent, treat Covid

AstraZeneca's antibody drug cut the risk of severe Covid-19 by at least 50% in a late stage study, the company announced on Monday. The injection, called AZD7442, contains two different antibodies developed from the the blood of people who previously contracted Covid-19. It's the drug first of its kind shown to both prevent and treat Covid-19 in late-stage trials, the company said in a press release. The company has already requested Food and Drug Administration (FDA) approval to use AZD7442 to prevent Covid-19, after late-stage trial results in August showed it reduced the risk of Covid-19 with symptoms by 77%.
11th Oct 2021 - Business Insider

Monoclonal antibody from AstraZeneca lowers risk for serious COVID-19, company says

An experimental drug developed by AstraZeneca reduces the risk for serious illness or death from COVID-19, company officials announced Monday. The drug, a combination of two monoclonal antibodies called AZD7442, lowers the risk of severe COVID-19 or death by 50% in people who have had symptoms for seven days or less, data from a clinical trial showed. Monoclonal antibodies are lab-created proteins modeled on those produced by the immune system to fight off infections. AZD7442 is delivered via injection and both prevents serious illness and treats its symptoms, the company said..
11th Oct 2021 - UPI.com

WHO experts back booster jabs for people with weak immune systems

The World Health Organization (WHO) on Monday recommended that immunocompromised people be given an additional dose of Covid-19 vaccine, due to their higher risk of breakthrough infections after standard immunisation. The Strategic Advisory Group of Experts on immunisation said the additional dose should be offered “as part of an extended primary series since these individuals are less likely to respond adequately to vaccination following a standard primary vaccine series and are at high risk of severe Covid-19 disease”. WHO vaccine director Kate O’Brien, referring to people with lower immunity due to other conditions, told a news briefing: “The recommendation is for a third vaccination, an additional vaccination in the primary series and again that is based on the evidence showing that the immunogenicity and evidence on breakthrough infections is highly disproportionately represented by those people.”
11th Oct 2021 - South China Morning Post

New Clues Emerge About Whether Vaccines Can Help Fight Long Covid

Millions of people suffer from symptoms of long Covid, doctors estimate. Now, early research is offering some clues about whether vaccinations might help. When the vaccines first came out, some people who had suffered from debilitating symptoms for months after their initial Covid-19 infections told their doctors they felt better after getting vaccinated. The response intrigued scientists. Now, emerging research suggests that vaccines may help reduce symptoms in some people. Other recent research indicates that vaccination can reduce the likelihood of developing long-term Covid-19 symptoms in the first place.
11th Oct 2021 - The Wall Street Journal

Merck Asks F.D.A. for Emergency Approval of Covid Pill

Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid. Clearance for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used. The Biden administration is preparing for an authorization that could come within weeks; the pill would likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors’ practices, senior administration officials said.
11th Oct 2021 - The New York Times

Merck Covid-19 Pill: Emergency Use Authorization Sought for Molnupiravir

Merck & Co. and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the U.S. for molnupiravir, moving the pill closer to becoming the first oral antiviral treatment for Covid-19. An application was submitted with the Food and Drug Administration for molnupiravir to treat mild-to-moderate Covid-19 in adults at risk of developing a severe illness that may require hospitalization, the companies said in a statement Monday. Submissions to regulatory authorities worldwide are expected in the coming months after an interim analysis of clinical trial data found it cut the risk of hospitalization for such patients by half.
11th Oct 2021 - Bloomberg

Merck seeks first U.S. authorization for COVID-19 pill

Merck & Co Inc said on Monday it has applied for U.S. emergency use authorization for its drug to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease. An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home. The treatment, molnupiravir, cut the rate of hospitalization and death by 50% in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease, according to data released earlier this month.
11th Oct 2021 - Reuters

COVID-19 vaccine trial participants to be offered additional doses

The government has announced the COVID-19 vaccine clinical trial participants in England will be offered additional approved vaccine for international travel to countries which currently only accept vaccination records with approved for deployment COVID-19 jabs. Although the UK recognises those who are in COVID-19 vaccine trials as fully vaccinated for the purpose of certification, most other countries do not currently recognise clinical trial volunteers who have not had a vaccine that is approved for deployment. As such, the government will now offer these volunteers two additional doses of an approved vaccine, allowing them to gain the necessary certification status to travel abroad with more ease.
11th Oct 2021 - PharmaTimes

Brii Biosciences files EUA with US FDA for Covid-19 combination therapy

Brii Biosciences has filled an emergency use authorization (EUA) application with the US Food and Drug Administration (FDA) for its combination therapy, BRII-196/BRII-198, to treat Covid-19 patients. BRII-196/BRII-198 is a SARS-CoV-2 neutralising monoclonal antibody combination therapy, which is intended to treat non-hospitalised Covid-19 patients at high risk of clinical progression to severe disease. The EUA submission is based on the positive Phase III results obtained from the ACTIV-2 clinical trial that was announced in August.
11th Oct 2021 - Pharmaceutical Technology

INOVIO Gets Approval To Conduct Phase 3 Trial Of COVID-19 DNA Vaccine Candidate,INO-4800 In Colombia

INOVIO said Monday that it has received authorization from Colombia's INVIMA to conduct the phase 3 segment of the company's global Phase 2/3 trial, INNOVATE in Colombia, for INO-4800, its DNA vaccine candidate for COVID-19. The company noted that it is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries in Latin America, Asia, and Africa.
11th Oct 2021 - Business Insider

Merck seeks first U.S. authorization for COVID-19 tablet

Japan's Chugai files to expand use of COVID-19 antibody drug

Japan's Chugai Pharmaceutical Co said on Monday it has applied to regulators to expand the use of an antibody treatment for COVID-19 to also allow for preventative care. Japanese regulators approved an antibody cocktail known as Ronapreve as a treatment for COVID-19 in July. The latest filing seeks to use the drug as both a prophylaxis for COVID-19 and as treatment of asymptomatic cases, Chugai said in a release.
11th Oct 2021 - Reuters

New antibody treatment ‘both prevents and treats Covid-19’

An antibody treatment developed by pharmaceutical giant AstraZeneca has shown its ability to both prevent and treat Covid-19, according to new data. AstraZeneca submitted a request to the US Food and Drug Administration (FDA) last week for emergency use authorisation for AZD7442, which is made up of two antibodies, as a preventative treatment. In new data released on Monday morning from its Tackle trial, AstraZeneca showed AZD7442 was effective in preventing severe disease in non-hospitalised patients with mild to moderate coronavirus, when compared with a placebo. Most of the 903 people in the trial were at high risk of progression to severe Covid-19, including those with multiple health conditions.
11th Oct 2021 - Evening Standard

Doctors claim Brazil hospitals gave dodgy COVID-19 care

Irene Castilho didn’t even have a day to grieve after her husband died of COVID-19. She was sick, too, coughing and struggling to breathe; he was barely gone when she started using his oxygen mask. The same day, on March 22, she was admitted to a hospital in Sao Paulo. The 71-year-old had followed doctors’ instructions to the letter – dutifully taking her doses of hydroxychloroquine. She also took ivermectin and a battery of anti-inflammatories and vitamins in the so-called “COVID kit” that her health care company, Prevent Senior, mailed to her home. Still, her condition had deteriorated. At the hospital, Castilho received dialysis and was intubated. When physicians consulted Castilho’s daughters about giving her flutamide — a drug typically used for prostate cancer – they declined, worried about possible side effects for their mother who recently had liver cancer.
11th Oct 2021 - The Associated Press

AstraZeneca says drug helps cut risk of severe COVID

Drugmaker AstraZeneca said that its COVID-19 antibodies’ cocktail has helped cut the risk of severe disease or deaths in a late-stage study. The pharma company announced the results on Monday, marking a boost in its effort to develop coronavirus medicines beyond vaccines. The drug, a mix of two antibodies called AZD7442, reduced the risk of severe COVID-19 or death by 50 percent in non-hospitalised patients who have had symptoms for seven days or fewer, meeting the main goal of the study. AstraZeneca’s therapy, delivered via injection, is the first of its kind to show promise as a preventive medicine and as a treatment for COVID-19 following multiple trials. It is designed to protect people who do not have a strong enough immune response to vaccines.
11th Oct 2021 - AlJazeera

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Oct 2021

View this newsletter in full

7% of Israel’s serious COVID cases had three vaccine shots

Some 7% of Israel’s serious and critical COVID-19 cases were vaccinated with three shots of the coronavirus vaccine, according to data released Friday morning by the Health Ministry. However, the number of new daily cases is declining and the government voted to roll out the Green Class outline in several green cities on Sunday to help keep children out of isolation. “I cannot say that 7% is a lot,” Health Minister Director-General Prof. Nachman Ash told The Jerusalem Post. “The vaccine, even the third shot, does not work at 100%. It is 95% effective.”
9th Oct 2021 - The Jerusalem Post

Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

Moderna, whose coronavirus vaccine appears to be the world’s best defense against Covid-19, has been supplying its shots almost exclusively to wealthy nations, keeping poorer countries waiting and earning billions in profit. After developing a breakthrough vaccine with the financial and scientific support of the U.S. government, Moderna has shipped a greater share of its doses to wealthy countries than any other vaccine manufacturer, according to Airfinity, a data firm that tracks vaccine shipments. About one million doses of Moderna’s vaccine have gone to countries that the World Bank classifies as low income. By contrast, 8.4 million Pfizer doses and about 25 million single-shot Johnson & Johnson doses have gone to those countries.
9th Oct 2021 - The New York Times

Novel vaccine strategy protects mice from COVID-19 and 4 related coronaviruses

The three marketed COVID-19 shots have validated the effectiveness of two vaccination technologies, mRNA and viral vector delivery. But the vaccines—from Pfizer/BioNTech, Moderna and Johnson & Johnson—only protect against SARS-CoV-2, the coronavirus that sparked the pandemic. So a team of researchers in Japan set out to develop a universal coronavirus vaccine in the hopes of preventing future pandemics. Scientists at Osaka University engineered antibodies that prevented SARS-CoV-2 from infecting healthy cells in mice, they reported in the Journal of Experimental Medicine. They were also effective against SARS-CoV-1, which caused a small outbreak in the early 2000s, and three coronaviruses found in pangolins and bats, they said. The experimental vaccination approach exploits the biology of the SARS-CoV-2 spike protein, which shuttles the virus into human cells by binding to a cell surface receptor called ACE2. The spike protein’s receptor-binding domain has a “head” region that facilitates that binding as well as a “core” region. While the head of each type of coronavirus is distinctive, the core regions are virtually identical.
9th Oct 2021 - FierceBiotech

Pregnant women with symptomatic COVID-19 have an increased risk of emergency deliveries

Pregnant women who contract symptomatic cases of COVID-19 are much more likely to suffer emergency complications or have babies who need intensive care, a new study suggests. Researchers from the University of Texas Medical Branch, Galveston, Texas, looked at more than 100 mothers-to-be who were diagnosed with the virus. More than half of pregnant women who developed symptoms had emergency deliveries compared to about four in 10 women without symptoms. Additionally, babies born to symptomatic mothers were more likely to need respiratory support or be admitted to neonatal intensive care units (NICUs).
9th Oct 2021 - Daily Mail on MSN.com

With more Covid-19 booster shots on the horizon, one expert says mixing and matching doses may be an effective approach

Amid the growing prospect of more Covid-19 booster shots becoming available, an expert has suggested that some people could receive a dose of a different vaccine from the one they initially received. "I hope that when the FDA and CDC review data around Moderna and Johnson & Johnson that they will allow a mix-and-match approach," CNN medical analyst Dr. Leana Wen said Friday. Vaccine advisers for the US Food and Drug Administration will meet October 14 and 15 to discuss applications for booster doses from Moderna and J&J's vaccine arm Janssen. And on October 20 and 21, vaccine experts with the US Centers for Disease Control and Prevention are slated to discuss the same course of action.
9th Oct 2021 - CNN

Merck drug less effective against moderate COVID -India regulatory source

Merck & Co's experimental antiviral drug molnupiravir has not shown "significant efficacy" against moderate COVID-19, a source with the Drug Controller General of India said. Aurobindo Pharma Ltd wants to discontinue a late-stage trial of molnupiravir in moderate COVID-19 patients, the regulator's expert committee said on Friday. "There is no significant efficacy against moderate COVID and the effective efficacy is towards mild cases," the source said on condition of anonymity due to the sensitive nature of the discussions.
9th Oct 2021 - Reuters

Iceland Joins Nordic Peers in Halting Moderna Covid Vaccinations

Iceland is joining its Nordic peers in halting inoculations with Moderna Inc.’s Spikevax shot on concern over side effects. The Moderna jab, which has mostly been used in Iceland for second doses, won’t be used until more information over its safety has been collected, the chief epidemiologist said on Friday. Sweden, Denmark and Finland have this week suspended the jabs for younger people because of the risk of heart inflammation as a potential side effect. Norway said men under 30 should consider choosing the Pfizer Inc.’s and BioNTech SE’s rival vaccine, and the other Nordic nations also recommended that as an alternative. Both vaccinations use messenger RNA technology to prompt an immune reaction.
9th Oct 2021 - Bloomberg

Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19

Two Indian drugmakers have requested permission to end late-stage trials of their generic versions of Merck & Co's promising experimental oral antiviral drug molnupiravir to treat moderate COVID-19, a week after Merck said its own trial had succeeded for mild-to-moderate patients. Merck earlier this year suspended its own development of molnupiravir as a treatment for hospitalized COVID-19 patients since many of them have reached a phase of the disease that is too late for an antiviral drug to provide much help.
9th Oct 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Oct 2021

View this newsletter in full

Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11

Pfizer and BioNTech said on Thursday morning that they had asked federal regulators to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States. The companies have said they were submitting data supporting the change to the Food and Drug Administration. The agency has promised to move quickly on the request and has tentatively scheduled a meeting on Oct. 26 to consider it. A ruling is expected between Halloween and Thanksgiving. “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against Covid-19,” Pfizer said on Thursday.
7th Oct 2021 - The New York Times

Covid Protection Wanes Months After Second Shot, Studies Show

Immunity provided by the Covid-19 vaccine from partners Pfizer Inc. and BioNTech SE weakens significantly within months, with men having less protection than women, according to research that supports the use of booster doses. Protective antibodies decreased continuously during the six months after the administration of the second dose of the vaccine, according to a study of about 5,000 Israeli health workers, published Wednesday in the New England Journal of Medicine. The levels fell first at a sharp pace and later at a more moderate one. Researchers worldwide are trying to identify the critical threshold of antibodies needed to prevent coronavirus infection, severe illness and death, said Gili Regev-Yochay, one of the authors of the study.
7th Oct 2021 - Bloomberg

Heart Damage Plagues Covid Survivors a Year After Infection, Study Shows

Heart damage from Covid-19 extends well beyond the disease’s initial stages, according to a study that found even people who were never sick enough to need hospitalization are in danger of developing heart failure and deadly blood clots a year later. Heart disease and stroke are already the leading causes of death worldwide. The increased likelihood of lethal heart complications in Covid survivors -- who number in the hundreds of millions globally -- will add to its devastation, according to the study, which is under consideration for publication by a Nature journal. “The aftereffects of Covid-19 are substantial,” said Ziyad Al-Aly, director of the clinical epidemiology center at the Veterans Affairs St. Louis Health Care System in Missouri, who led the research. “Governments and health systems must wake up to the reality that Covid will cast a tall shadow in the form of long Covid, and has devastating consequences. I am concerned that we are not taking this seriously enough.”
7th Oct 2021 - Bloomberg

Germany recommends booster shots for over 70s

Germany's vaccination authority, STIKO, recommended COVID-19 vaccine booster shots for people older than 70 on Thursday. All residents of care homes, as well as workers who come into direct contact with them, should also be offered a third vaccine dose, the body said. The same was also recommended for medical workers in direct contact with patients. STIKO gave its recommendation on the grounds that vaccine protection "declines over time, particularly in terms of preventing asymptomatic and mild infections." Previously booster shots had only be recommended in Germany for people with a weakened immune system.
7th Oct 2021 - DW (English)

Pfizer officially asks the FDA to authorize its COVID vaccine for kids aged 5-11

Pfizer and BioNTech are officially asking the Biden administration to authorize the use of their COVID-19 vaccine for children ages 5 to 11. Pfizer tweeted on Thursday that the companies had submitted their formal request for Emergency Use Authorization of the vaccine to the Food and Drug Administration. "With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," the pharmaceutical giant said.
7th Oct 2021 - NPR

Long Covid officially defined for first time - with three top symptoms listed

Long Covid has finally been given its own definition by the World Health Organisation as more than a million in the UK are said to be battling the condition. The condition has remained one of the most mysterious aspects of the virus as the list of symptoms continued to baffle medics. The WHO has sought to come up with clinical analysis of the symptoms as it formally says Long Covid is a "post-Covid condition". Common symptoms officially include fatigue, shortness of breath, cognitive dysfunction
7th Oct 2021 - The Mirror

Pfizer vaccine for children may be ready by Thanksgiving -White House adviser

Pfizer Inc's new vaccine for children aged five to 11 could be ready as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on Thursday. The Food and Drug Administration has scheduled time to review the Pfizer/BionNTech application for emergency use with its advisory panel at the end of October, to be followed by recommendations from the Centers for Disease Control and Prevention, Zients told CNN.
7th Oct 2021 - Reuters

Pfizer, BioNTech ask U.S. regulators to OK COVID-19 vaccine for kids

Pfizer Inc and BioNTech said on Thursday they had asked U.S. regulators to approve emergency use of their COVID-19 vaccine for children aged from five to 11, Pfizer said in a post on Twitter.
7th Oct 2021 - Reuters on MSN.com

Covid vaccination on top of past coronavirus infection 'gives greater protection'

Previous Covid-19 infection gives double jabbed people greater protection, new research suggests. According to the Zoe study, past Covid infection together with being fully vaccinated increases an individual’s protection against the virus to as much as 94%.
7th Oct 2021 - The Scotsman

Pfizer study to vaccinate whole Brazilian town against COVID-19

Pfizer Inc will study the effectiveness of its vaccine against COVID-19 by inoculating the entire population over the age of 12 in a town in southern Brazil, the company said on Wednesday. The study will be conducted in Toledo, population 143,000, in the west of Parana state, together with Brazil's National Vaccination Program, local health authorities, a hospital and a federal university. Pfizer, which developed the vaccine with German partner BioNTech SE , said the purpose was to study transmission of the coronavirus in a "real-life scenario" after the population has been vaccinated.
7th Oct 2021 - Reuters

Long COVID: More than one million people report ongoing coronavirus symptoms, ONS data shows

More than one million people living in the UK are experiencing the after-effects of COVID-19 following infection, according to the Office for National Statistics. It is the largest monthly increase - up from 970,000 in the previous ONS survey - with 1.1 million people in private households reporting having long COVID during the four weeks to 5 September. Long COVID is defined as symptoms which last for more than four weeks after individuals first suspect they are infected, and are not explained by something else.
7th Oct 2021 - Sky News

Seven people may have brought Covid-19 into NI, experts say

Seven people who were exposed to Covid-19 but had neither symptoms nor were infectious may have brought the virus into Northern Ireland on 1 March 2020. Researchers at Queen's University Belfast suggest it took about 9.6 days for someone exposed to Covid to develop symptoms and become infectious. They said a symptomatic patient could spread the disease for nine days. Experts from the school of mathematics and physics used modelling to reach their conclusions. Dr Gabor Kiss, who led the research, said the number seven was significant because while this seems a small number, the consequences demonstrate "just how infectious Covid-19 is".
7th Oct 2021 - BBC News

Pfizer asks US to allow COVID shots for kids ages 5 to 11

Parents tired of worrying about classroom outbreaks and sick of telling their elementary school-age children no to sleepovers and family gatherings felt a wave of relief Thursday when Pfizer asked the U.S. government to authorize its COVID-19 vaccine for youngsters ages 5 to 11. If regulators give the go-ahead, reduced-dose kids’ shots could begin within a matter of weeks. That could bring many families a step closer to being done with remote learning, virus scares and repeated school shutdowns and quarantines.
7th Oct 2021 - The Associated Press

Merck's molnupiravir will be a blockbuster drug during pandemic. What about endemic COVID-19?

After showing a 50% reduction in the risk of hospitalization or death, Merck & Co.’s molnupiravir looks on track to secure an FDA emergency use authorization and become a blockbuster earner during the pandemic. But what kind of longer-term market will the drug face once COVID-19 makes the likely shift from pandemic to endemic? After showing a 50% reduction in the risk of hospitalization or death, Merck & Co.’s molnupiravir looks on track to secure an FDA emergency use authorization and become a blockbuster earner during the pandemic. But what kind of longer-term market will the drug face once COVID-19 makes the likely shift from pandemic to endemic?
7th Oct 2021 - FiercePharma

Flu shots and Moderna's COVID-19 booster can be given during the same doctor's visit, Sanofi study finds

With the arrival of autumn and warnings of a potential “twindemic,” many are prioritizing vaccinations with more urgency this year. Thursday, Sanofi provided timely data that show elderly people can take care of their COVID-19 booster and flu inoculation needs in one stop. Interim results from co-administration of Sanofi’s Fluzone high-dose quadrivalent vaccine and a Moderna COVID-19 booster in the same doctor’s visit show that both provide similar immunogenicity responses—in addition to comparable safety and tolerability profiles—to when they are provided individually.
7th Oct 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Oct 2021

View this newsletter in full

Booster shot improves immune response of chemotherapy patients; post-COVID depression helped by widely used drugs

A new study helps quantify the improved protection against COVID-19 achieved with a third booster dose of the vaccine from Pfizer Inc (PFE.N) and BioNTech SE in cancer patients who are undergoing chemotherapy. "Chemotherapy can weaken the ability of cancer patients to fight off infections and to respond appropriately to vaccines," said Deepta Bhattacharya of the University of Arizona College of Medicine, coauthor of the study reported in Nature Medicine. Her team studied 53 patients receiving chemotherapy for solid-tumor cancers who received two shots of the vaccine. Almost all of the subjects had an immune response after vaccination. But "the magnitude of these responses was worse than in people without cancer in almost every metric that we measured," Bhattacharya said. "In all likelihood, this leaves cancer patients more susceptible to infection and COVID-19 than healthy vaccinated people." The researchers were able to bring back 20 of the study participants for a third vaccine dose, to see if immune responses would improve.
7th Oct 2021 - Reuters

FDA Is Reviewing Data on Mixing and Matching Boosters, Fauci Says

A study of adults who received booster doses of different Covid-19 vaccines than their original shots has been completed, Fauci said in an interview on Bloomberg Television’s “Balance of Power with David Westin,” and the data have been presented to the U.S. Food and Drug Administration. The National Institutes of Health study looked at the safety, immunogenicity and efficacy of mixing and matching of the three U.S. authorized vaccines for booster purposes. The vaccine from partners Pfizer Inc. and BioNTech SE has been cleared as a booster for vulnerable people, such as the elderly and immunocompromised. Next up for the FDA and the Centers for Disease Control and Prevention is consideration of boosters from Moderna Inc. and Johnson & Johnson.
6th Oct 2021 - Bloomberg on MSN.com

Sweden Halts Moderna's Covid Vaccine for People Aged 30 or Under

Sweden and Denmark decided to halt vaccinations with Moderna Inc.’s Covid-19 shot for younger people because of potential side effects. The Swedish health authority Wednesday cited new data on the increased risk of heart inflammation as a reason for the pause for those aged 30 and under. Denmark will stop giving the shot to those younger than 18. Moderna shares fell as much as 5.3% in New York trading. “We are monitoring the situation closely and are acting rapidly to ensure that Covid-19 vaccinations are constantly as safe as possible, while also providing protection,” said Anders Tegnell, Sweden’s chief epidemiologist.
6th Oct 2021 - Bloomberg

Italy says mRNA COVID jab effectiveness stable after 7 months, but not for all

Seven months after the second dose, there is no reduction in the efficacy of COVID-19 mRNA vaccines in the general population in Italy, while a slight decline is seen for some specific groups, the National Health Institute (ISS) said on Wednesday. The report led by ISS and the health ministry examined data up to Aug. 29 from more than 29 million people who had received two doses of an mRNA vaccine such as those produced by Pfizer and Moderna. It said that in the general population, effectiveness against infection after seven months remained at 89%, while against hospitalisation and death, this time six months after the second dose, it remained at 96% and 99% respectively.
6th Oct 2021 - Reuters

Sweden pauses use of Moderna COVID vaccine, cites rare side effects

Sweden will pause the use of Moderna's COVID-19 vaccine for people born 1991 and later after reports of possible rare side effects, such as myocarditis, the Swedish health agency said on Wednesday. "The Swedish Public Health Agency has decided to suspend the use of Moderna's vaccine Spikevax, for everyone born 1991 and later, for precautionary reasons," it said in a statement. "The cause is signals of an increased risk of side effects such as myocarditis and pericarditis. However, the risk of being affected is very small," it said.
6th Oct 2021 - Reuters on MSN.com

Scancell Doses First Subject in Coronavirus Vaccine Trial

Scancell Holdings PLC said Tuesday that it has dosed its first subject in its clinical trial for its Scov1 and Scov2 vaccine candidates, which aim to protect against all Covid-19 variants of concern. The biopharmaceutical company said that the first patient was dosed in South Africa as part of the program dubbed Covidity, and the candidate was administered using the PharmJet needle-free injection system. The objectives of the first part of the trial are to assess the safety and immunogenicity of Scov1 and Scov2, which target the original virus and variant viruses respectively, in healthy, non-vaccinated subjects.
6th Oct 2021 - MarketWatch

Merck says deal signed with Singapore on COVID-19 antiviral pill

Merck announced on Wednesday a supply and purchase agreement that will provide Singapore with access to its experimental oral COVID-19 antiviral drug, the latest Asian country to try to snap up supplies. Molnupiravir is designed to introduce errors into the genetic code of the virus and would be the first oral antiviral medication for COVID-19. Merck is seeking approval by the United States Food and Drug Administration for the pill.Singapore's health ministry did not immediately respond to a request for confirmation of the Merck agreement.
6th Oct 2021 - Reuters

Long COVID may affect almost 37% of COVID-19 patients

Individuals with long COVID exhibit lingering symptoms, such as fatigue and brain fog, that persist beyond the typical recovery period of 3–4 weeks after the symptom onset. A recent study assessed the incidence of long COVID symptoms using data extracted from de-identified electronic health records. The study found that more than one in three individuals experienced long COVID symptoms 3–6 months after receiving a COVID-19 diagnosis. The study also reports that women, older adults, and individuals with severe illness during the initial phase of a SARS-CoV-2 infection had an increased likelihood of experiencing long COVID symptoms.
6th Oct 2021 - Medical News Today

Australia's Ellume recalls some COVID-19 test kits over false positives

Australian diagnostic test maker Ellume has recalled some lots of its COVID-19 home test, saying they may show false-positive results due to a recently identified manufacturing issue. The company said of the 427,000 tests that were affected, it had recalled about 195,000 tests as they were unused. "Ellume has investigated the issue, identified the root cause and implemented additional controls," the company told Reuters on Wednesday.
6th Oct 2021 - Reuters

UAE authorises Sputnik Light COVID-19 vaccine -Russia's RDIF

The United Arab Emirates has authorised the Russia-developed one-shot Sputnik Light as both a standalone COVID-19 vaccine and a booster shot, Russia's sovereign fund RDIF said on Wednesday.
6th Oct 2021 - Reuters

Swindon site to produce Covid-19 vaccines, PM says

Doses of the Pfizer Covid-19 vaccine are to be made in Swindon, Prime Minister Boris Johnson has announced. It will be made at the Thermo Fisher Scientific site and production is expected to start in 2022. The firm already makes the vaccine at its facility in Monza, Italy. A statement from Pfizer said that regulatory approval, transfer of technology and on-site development work means production cannot immediately begin. It added: "The support from Thermo Fisher - one of more than 20 contract manufacturers across four continents that are - or will be - helping manufacture the vaccine is an example of our efforts to deliver the vaccine to people around the world as quickly as possible."
6th Oct 2021 - BBC News

Covid-19 reinfection rate remains low, analysis shows

The rate of Covid-19 reinfections “remains low”, according to new analysis. When people do get infected for a second time, the virus is much less likely to cause serious illness, according to the Office for National Statistics (ONS). Reinfections become more likely as time goes on, the analysis suggested. It also highlighted how some people are more likely to be reinfected than others. Kara Steel, senior statistician for the Covid-19 Infection Survey, said: “The analysis shows that the estimated number of Covid-19 reinfections in the UK remains low.
6th Oct 2021 - Evening Standard

Cloth vs N95: Which coronavirus mask should you wear?

Mask wearing has been a hotly debated topic, but most scientists agree that face coverings do help reduce the spread of the coronavirus, though the degree to which they do so depends on the quality of the masks themselves. Because about one in three people who have COVID-19 display no symptoms at all, widespread use of masks remains important. A study which reviewed the evidence on mask wearing found in favour of widespread mask use by infected people as a way to help reduce community transmission, concluding that the available evidence suggests that near-universal adoption of any face covering at all, in combination with complementary public health measures, could successfully reduce the community spread of COVID. Models suggest that public mask wearing is most effective at reducing the spread of the virus when compliance is high.
6th Oct 2021 - AlJazeera

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Oct 2021

View this newsletter in full

Long Covid Symptoms May Be Caused by Micro Clots, Scientists Say

Some of the symptoms of so-called long-covid, the ailments that can persist for months after a Covid-19 infection, may be caused by inflammatory molecules trapped inside tiny blood clots, a scientist at South Africa’s Stellenbosch University said. High levels of inflammatory molecules were found in micro clots in blood samples from people with long-covid, Resia Pretorius, a researcher at the university, said in a statement on Monday. The molecules contained fibrinogen, a clotting protein, and alpha(2)-antiplasmin, which prevents the breakdown of blood clots, she said. These “might be the cause of some of the lingering symptoms experienced by individuals with long-covid,” the university said in the statement. This “provides further evidence that Covid-19, and now long-covid, have significant cardiovascular and clotting pathologies.”
5th Oct 2021 - Bloomberg

Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, study shows

The effectiveness of the Pfizer Inc/BioNTech SE vaccine in preventing infection by the coronavirus dropped to 47% from 88% six months after the second dose, according to data published on Monday that U.S. health agencies considered when deciding on the need for booster shots. The data, which was published in the Lancet medical journal, had been previously released in August ahead of peer review. The analysis showed that the vaccine's effectiveness in preventing hospitalization and death remained high at 90% for at least six months, even against the highly contagious Delta variant of the coronavirus.
5th Oct 2021 - Reuters

Spain approves COVID booster shot for over 70s

Spain on Tuesday approved administering of third doses of the Pfizer and Moderna vaccines, which are based on the same messenger RNA technology, for people aged 70 or over, the health ministry said. Spain has fully vaccinated around 78% of its population, and authorised the booster shot from six months after people receive their second jab, the ministry said in a statement. The campaign to administer the boosters will begin at the end of October. The country had already authorised booster shots for cancer patients, nursing home residents and other vulnerable groups.
5th Oct 2021 - Reuters

Johnson & Johnson seeks emergency authorization from FDA for coronavirus booster shot

Johnson & Johnson asked the Food and Drug Administration on Tuesday to grant emergency use authorization for a booster dose of its single-shot coronavirus vaccine. The action is part of an effort by Biden administration officials to provide increased protection against covid-19, the disease caused by the coronavirus, which has claimed more than 700,000 lives in the United States. Johnson & Johnson “is asking the FDA to look at our data and agree with us that we have enough data to support a boost” for people 18 and older, said Mathai Mammen, global head of research and development for the Janssen Pharmaceuticals division of Johnson & Johnson.
5th Oct 2021 - The Washington Post

CHMP positive option for Pfizer-BioNTech COVID-19 vaccine in the EU

Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the administration of the Pfizer-BioNTech COVID-19 vaccine as a booster shot six months after the second dose. CHMP, part of the EMA, has approved the use of the booster jab for individuals over the age of 18. Following the CHMP positive opinion, the European Commission (EC) will make a final decision on its update to the vaccine’s current Conditional Marketing Authorisation in the EU. In the clinical trial data provided by Pfizer and BioNTech, the COVID-19 vaccine, Comirnaty, was found to elicit significantly higher neutralising antibody titers against SARS-CoV-2, and protection from both the Beta and Delta variants of the disease.
5th Oct 2021 - PharmaTimes

Merck and Ridgeback Biotherapeutics’ Oral Antiviral COVID-19 Treatment Reduces Risk of Hospitalization or Death by 50%

Merck, known as MSD outside of the United States and Canada, and Ridgeback Therapeutics announced on Oct. 1st, 2021, that their investigational oral antiviral medicine molnupiravir significantly reduced severe outcomes associated with COVID-19. According to a planned interim analysis, molnupiravir reduced the risk of hospitalization or death by 50% in non-hospitalized adult COVID-19 patients with mild-to-moderate symptoms. According to a company press release, 7.3% of patients who received molnupiravir (28/385) were either hospitalized or died through Day 29 of the study. Conversely, 14.1% of patients given placebo (53/377) were either hospitalized or died as a result of COVID-19 through Day 29. Additionally, no patients that were given molnupiravir died, whereas eight of those given the placebo did.
5th Oct 2021 - PharmTech

COVID-19: AstraZeneca requests emergency authoritisation in US or drug that reduces risk of developing coronavirus symptoms by 77%

AstraZeneca has requested US authorisation for emergency use of its new treatment to prevent COVID-19 in people who have a lessened response to vaccines because of a weakened immune system. The drugmaker included data in its filing with the Food and Drug Administration from a late-stage trial showing the jab reduced the risk of people developing any coronavirus symptoms by 77%. The antibody therapy, called AZD7442, could be used to protect people who do not have a strong enough immune response to COVID vaccines, or as a booster for those such as military personnel, AstraZeneca said.
5th Oct 2021 - Sky News

COVID-19: Pfizer-BioNTech vaccine effectiveness wanes to 47% against infection after six months

Two doses of the Pfizer-BioNTech vaccine are 90% effective against COVID-19 hospitalisation for at least six months but only 47% effective against infection after that period, according to a new study. The peer-reviewed analysis of the coronavirus jab, published in The Lancet, also found that reductions in the vaccine's effectiveness against COVID-19 infection was due to this waning over time rather than the Delta variant escaping protection. Researchers analysed the electronic health records of 3,426,957 people who had received the Pfizer-BioNTech vaccine as part of the study, 5.4% of which (184,041) belonged to people who were infected and 6.6% (12,130) of those which were hospitalised.
5th Oct 2021 - Sky News

J&J seeks US clearance for COVID-19 vaccine booster doses

Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans. J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company’s one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators. Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity.
5th Oct 2021 - The Associated Press

EU regulator OKs Pfizer vaccine booster for 18 and older

The European Union’s drug regulator gave its backing Monday to administering booster shots of the Pfizer-BioNTech COVID-19 vaccine for people 18 and older. The European Medicines Agency said the booster doses “may be considered at least 6 months after the second dose for people aged 18 years and older.” The agency’s human medicines committee issued the recommendation after studying data for the Pfizer vaccine that showed a rise in antibody levels following boosters given around 6 months after the second dose in people from 18 to 55 years old. The agency also said it supports giving a third dose of either the Pfizer-BioNTech or the Moderna vaccine to people with severely weakened immune systems at least 28 days after their second shot.
5th Oct 2021 - The Associated Press

Merck's molnupiravir will be 'complementary, but not a competitor' to COVID-19 vaccines: analyst

What do Merck’s eye-opening data, recently released for its antiviral molnupiravir on high-risk COVID-19 patients, mean for manufacturers of vaccines? Analysts from the ODDO BHF financial services group see little impact in the short and intermediate term. Even though inoculation rates are low in most lesser developed countries, ODDO says it’s unlikely that countries will shift away from vaccination campaigns to focus primarily on treating high-risk patients with COVID. This is the case despite trial data showing molnupiravir providing a 50% reduction in the hospitalization rate and a 100% reduction in the death rate among patients within five days of symptomatic illness. “The impact on vaccine manufacturers such as Moderna should be limited,” ODDO wrote in a report to investors. “We believe that molnupiravir can be complementary to the COVID-19 vaccine but not a competitor.”
5th Oct 2021 - FiercePharma

Why U.S. pandemic management has failed: lack of attention to America’s epidemic engines

Few U.S. journalists, politicians, or public health officials expressed any extraordinary concern when reports of a novel respiratory virus began to emerge out of China in late 2019 and early 2020. After all, the U.S. had just ranked number one among 195 countries in the 2019 Global Health Security Index — the first major comparative assessment of national capacity to prevent, detect, and respond to infectious disease outbreaks. Experts believed the wealthiest large nation on earth to be well-prepared to weather whatever might come its way. Now, nearly two years since the first documented cases of Covid-19 appeared in Wuhan, more than 700,000 U.S. residents have been killed by a pandemic during which U.S. public health management has been among the world’s worst. Despite American wealth, monopolization of the global vaccine supply, and unparalleled spending on medical care, SARS-CoV-2 has decimated U.S. communities — especially those of color and lower incomes. Repeated policy failures have paved the way for the virus to rapidly replicate, mutate, and fuel deadly outbreaks not just inside this country but worldwide.
5th Oct 2021 - STAT News

What we know — and don’t know — about Merck’s new Covid-19 pill

The announcement that a pill from Merck and partner Ridgeback Biotherapeutics kept Covid patients out of the hospital made headlines and moved stocks late last week. But as is so often true when data are released by press release, there are still many questions left unanswered. Doctors are excited about the medicine, molnupiravir, because a regimen of pills, even one that involves taking several pills twice a day for five days, should be far easier to deliver to patients than current antiviral Covid-19 treatments, which must be given intravenously. But it’s still unclear how widely this treatment will be used. There will also be debate among financial analysts at investment banks regarding exactly how many billions of dollars in sales the new drug will generate.
4th Oct 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Oct 2021

View this newsletter in full

EU regulator backs Pfizer vaccine booster for all adults after 6 months

Europe’s drugs regulator on Monday advised that healthy adults can receive a third, booster dose of the BioNTech/Pfizer COVID-19 vaccine six months after the second dose. The European Medicines Agency’s medicines committee said the recommendation was based on data from a study of 18 to 55-year-olds, showing an increase in antibodies after a third shot. Data has shown that immunity wanes with the vaccines currently in use, and appears to wane more quickly with the BioNTech/Pfizer jab. The EMA also said that people with severely weakened immune systems may be given a booster dose of either the BioNTech/Pfizer or Moderna jabs just 28 days after their second dose. While there is no direct evidence linking antibody levels to stronger protection in those with weakened immune systems, “it is expected that the extra dose would increase protection at least in some patients,” the EMA said.
4th Oct 2021 - POLITICO Europe

Covid-19 Treatment News: What Drugs, Medicines Are Available for Coronavirus?

In the battle against the Covid-19 pandemic, vaccines have emerged as the weapon of choice. Prevention of disease is always preferable to treatment, and in this case, vaccines have proven far more targeted and effective than the few Covid therapies that have emerged so far. Several, including some that received emergency-use authorization from regulators, have lost favor or been discarded as the struggle goes on to understand the coronavirus that causes Covid and how it impacts cells, tissues and ultimately the human body. While the list of disappointments is long, some treatments have been shown to work, although more research is needed to provide effective therapy for severely ill patients.
4th Oct 2021 - Bloomberg

Pfizer, Moderna Boosters Win EU Approval for Vulnerable

A European Union advisory committee endorsed extra shots of Pfizer Inc.’s Covid-19 vaccine for all adults, as well as extra doses of Moderna Inc.’s for those with severely weakened immune systems. Those ages 18 and older can get a third dose of the Pfizer vaccine, developed with BioNTech SE, at least six months after their second shot, the European Medicines Agency said in a statement Monday. For the immunocompromised, extra doses of Pfizer or Moderna can be given at least 28 days after the second. The recommendation on the Pfizer shot is slightly broader than in the U.S., where it’s been recommended for those ages 65 or older, those in long-term health-care facilities and those ages 50 to 64 with underlying medical conditions. “Studies showed that an extra dose of these vaccines increased the ability to produce antibodies against the virus that causes Covid-19 in organ transplant patients with weakened immune systems,” the EMA said. “It is expected that the extra dose would increase protection at least in some patients.”
4th Oct 2021 - Bloomberg

Israel requires COVID-19 booster shots for stricter "green pass"

Israel on Sunday piled pressure on its vaccinated citizens to get a booster shot by making only those who received their third dose of the COVID-19 vaccine eligible for a "green pass" allowing entry to restaurants, gyms and many other venues. Israel was an early adopter of Pfizer/BioNtech booster shots -- administering them to members of risk groups in July and by the end of August to anyone above the age of 12. Its campaign is being watched closely by other countries. The new green pass is being issued to those who received three shots or recently recovered from COVID-19, replacing a previous system that required just two shots. It raises the bar for what the government considers full immunization
4th Oct 2021 - Reuters

Covid-19 vaccines, declining antibodies and the immune memory

Countries around the world are considering or already rolling out Covid-19 vaccine booster shots amid reports of waning immunity and breakthrough infections. As debate rages over boosters, some are asking why they might be necessary so soon after vaccination, when there should still be immune memory. Vaccines work to “train” the body to fight a specific pathogen, using inactive or weakened parts of it, or a blueprint of it, to prompt an immune system response. The body then produces antibodies, but also white blood cells known as memory cells. When the antibodies gradually level off, the memory cells remain and swing into action when faced with the real pathogen – a process known as memory response.
4th Oct 2021 - South China Morning Post

Coronavirus: BioNTech CEO says new vaccine will be needed in 2022

The CEO of BioNTech, the company that paired with Pfizer to develop a COVID-19 vaccine, told The Financial Times on Sunday that a new vaccine formula will probably be needed by the middle of next year, as new variants to the virus are likely to emerge. Ugur Sahin, who co-founded BioNTech, said that the variants seen now are not so different from the original virus as to evade the protection that the current vaccine offers. However, Sahin warns that new variants will emerge that will be able to evade vaccines and booster shots. “This year [a different vaccine] is completely unneeded,” he said. “But, by mid-next year, it could be a different situation.”
4th Oct 2021 - KIRO Seattle

To Prevent the Next Pandemic, Scientists Seek One Vaccine for Many Coronaviruses

Kayvon Modjarrad is out to win the war against this pandemic—and the next one. An emerging-infectious-diseases researcher with the U.S. Army, Dr. Modjarrad is pursuing a vaccine to protect against a range of coronaviruses that cause disease in humans—including Covid-19 variants that might elude today’s vaccines. The goal is to prevent the next new one from spreading around the globe. Such a shot might even stop coronaviruses that cause some common colds. His research team is one of roughly 20 groups around the world working on so-called universal, or pan-coronavirus, vaccines: shots that would block many related viruses at once, including ones that have yet to infect anyone. After years of battling Ebola, Zika, H1N1 pandemic flu and other new pathogens, Dr. Modjarrad and other emerging-disease experts say they want to have a vaccine in hand to blunt the next new pathogen to come along, whatever it may be.
4th Oct 2021 - The Wall Street Journal

Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot

Johnson & Johnson is planning to ask federal regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least the elderly and other high-risk groups need more protection. Federal officials have become increasingly worried that the more than 15 million Americans who received the Johnson & Johnson vaccine face too much risk of severe Covid-19. The Food and Drug Administration on Friday scheduled a meeting on Oct. 15 of its expert advisory committee to discuss whether to grant emergency use authorization of a booster shot of Johnson & Johnson’s vaccine. That is part of a broader effort by the government to shore up the protection provided by all three vaccines. Regulators last month authorized a booster shot for many recipients of Pfizer-BioNTech’s vaccine and are contemplating doing the same this month for recipients of Moderna’s.
4th Oct 2021 - The New York Times

Largest COVID-19 PCR provider announces expansion of ‘cube’ labs

The UK’s largest laboratory diagnostics company, Randox, has announced a nationwide expansion of ten new adaptive ‘cube’ laboratories across Great Britain, with facilities that provide a rapid and cost-effective model to expand laboratory provision.
4th Oct 2021 - PharmaTimes

Pregnant Women Benefit from Getting the COVID-19 Vaccination

The number of women who were pregnant and also hospitalized for COVID-19 increased from 10% to 15% in late August 2021 and early September 2021, which is more than double the percentages of a year earlier, results of a study posted in the American Journal of Obstetrics and Gynecology show. "If they are exposed and infected, they run a higher risk of severe illness from this most recent Delta variant," Emily Adhikari, MD, medical director of perinatal infectious diseases at Parkland Health and Hospital System, said in a statement. "Pregnant women should get immunized as soon as possible." Investigators found that these findings are the first objective evidence of the number and severity of illness in pregnant individuals alongside the spike in the Delta variant.
4th Oct 2021 - Pharmacy Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Oct 2021

View this newsletter in full

Covid-19: Immunosuppressed to be offered booster jab 'shortly'

People who are immunosuppressed in Northern Ireland will be notified shortly about receiving a third dose of the vaccine. The Department of Health told BBC News NI those classed as immunosuppressed have now been identified. "They will be receiving a letter shortly advising them to book online to receive the third dose," it said. "Those identified by GPs will be given a letter advising them to receive a third dose at a community pharmacy." Vaccine experts recommended on 1 September that those affected should be given the extra dose to give them fuller protection.
3rd Oct 2021 - BBC News

Merck says experimental pill cuts worst effects of COVID-19

Drugmaker Merck said Friday If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.
2nd Oct 2021 - San Francisco Chronicle

Merck says COVID-19 pill cuts risk of death, hospitalization

In a potential leap forward in the global fight against the pandemic, drugmaker Merck said Friday that its experimental pill for people sick with COVID-19 reduced hospitalizations and deaths by half. If cleared by regulators, it would be the first pill shown to treat COVID-19, adding a whole new, easy-to-use weapon to an arsenal that already includes the vaccine. The company said it will soon ask health officials in the U.S. and around the world to authorize the pill’s use. A decision from the U.S. Food and Drug Administration could come within weeks after that, and the drug, if it gets the OK, could be distributed quickly soon afterward.
2nd Oct 2021 - The Associated Press

Merck Pill Intended to Be Covid-19’s Tamiflu Succeeds in Key Study

Drug jointly developed by Merck with Ridgeback Biotherapeutics cut risk of hospitalization or death by 50% in early look at progress. Merck & Co. and its partner Ridgeback Biotherapeutics LP said their experimental Covid-19 pill helped prevent high-risk people early in the course of the disease in a pivotal study from becoming seriously ill and dying, a big step toward providing the pandemic’s first easy-to-use, at-home treatment. The pill cut the risk of hospitalization or death in study subjects with mild to moderate Covid-19 by about 50%, the companies said Friday. The drug, called molnupiravir, was performing so well in its late-stage trial that Merck and Ridgeback said they stopped enrolling subjects after discussions with the U.S. Food and Drug Administration.
2nd Oct 2021 - The Wall Street Journal

F.D.A. Panel to Weigh Pfizer Shots for Children, Boosters for Moderna and Johnson & Johnson Recipients

The Food and Drug Administration on Friday scheduled three days of public meetings with its panel of independent vaccine experts for later this month, as the agency prepares to make high-profile decisions on whether to authorize emergency use of the Pfizer-BioNTech vaccine for children ages 5 to 11 and booster shots for adult recipients of the Moderna and Johnson & Johnson vaccines. The F.D.A. typically issues its decisions within a few days of advisory committee meetings, during which members discuss safety and efficacy data. The timing of the upcoming meetings indicates that the agency intends to move quickly to decide whether to authorize both the booster and children’s shots.
2nd Oct 2021 - The New York Times

Is the Coronavirus Getting Better at Airborne Transmission?

Newer variants of the coronavirus like Alpha and Delta are highly contagious, infecting far more people than the original virus. Two new studies offer a possible explanation: The virus is evolving to spread more efficiently through air. The realization that the coronavirus is airborne indoors transformed efforts to contain the pandemic last year, igniting fiery debates about masks, social distancing and ventilation in public spaces. Most researchers now agree that the coronavirus is mostly transmitted through large droplets that quickly sink to the floor and through much smaller ones, called aerosols, that can float over longer distances indoors and settle directly into the lungs, where the virus is most harmful.
2nd Oct 2021 - New York Times

Flu's Return Will Shape the Pandemic's Impact in Coming Months

Charting the course of the pandemic during the coming months is likely to involve a more traditional winter nuisance: the flu. As countries from Italy to Canada lift restrictions, travel resumes and colder temperatures set in, influenza will probably start circulating as well. That’s after measures to thwart Covid-19 such as masks and ventilation kept the flu at bay for the past year and a half. Efforts have already been under way to lessen the potential strain on health systems dealing with both illnesses. A U.K. study released late Thursday showed that it’s safe for people to get Covid and flu shots at the same time, which might help increase vaccine uptake and cut down on appointments as the country rolls out booster doses.
1st Oct 2021 - Bloomberg

FDA advisory panel to discuss J&J, Moderna booster shots this month

An advisory panel of experts to the U.S. drug regulator will hold meetings this month to review data on Pfizer Inc's COVID-19 vaccine in young children, and whether to clear booster doses of Moderna and Johnson & Johnson's vaccines. The U.S. Food and Drug Administration's announcement on Friday comes as health authorities seek to mitigate a potential surge of cases this fall, with schools already open nationwide. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel will hold a meeting on Oct. 14 to discuss a booster dose of Moderna vaccine, and Johnson & Johnson on Oct. 15.
1st Oct 2021 - Reuters

Britain's antiviral chief hints at interest in Merck COVID-19 pill

The chair of Britain's antivirals taskforce declined to comment directly about talks over Merck & Co Inc's (MRK.N) experimental oral COVID-19 drug molnupiravir, but hinted at Britain's interest in buying the potential breakthrough pill. Taskforce chair Eddie Gray was speaking to reporters after interim clinical trial results published on Thursday showed molnupiravir reduced the chance of hospitalisation or death for patients at risk of severe disease by about 50%. "We are involved in looking closely at all of the options available, but we're really not in a position to give out the details around specific conversations at this moment in time," he told a briefing about molnupiravir after the results were published, which was also attended by a Merck representative.
1st Oct 2021 - Reuters

J&J's one-shot COVID vaccine is linked to ANOTHER blood clotting condition by EU regulators

The European Medicines Agency (EMA) on Friday found a possible link between. Johnson & Johnson's COVID-19 vaccine and venous thromboembolism (VTE). VTE is a condition in which a blood clot forms in a deep vein, usually in a leg, arm or groin, and may travel to the lungs causing a blockage of the blood supply. It could cause possible life-threatening consequences, especially to seniors. The agency is recommending that the condition be listed as a rare side effect. It also recommends that immune thrombocytopenia (ITP) be listed as a side effect of the J&J vaccine and AstraZeneca's vaccine. ITP is a bleeding disorder which sees sufferers' bodies mistakenly attack their own platelets
1st Oct 2021 - Daily Mail

US, UK adults report pandemic-related distress, disruptions

Yesterday in JAMA Network Open, Johns Hopkins University and University of California Los Angeles researchers analyzed self-reported health and psychological status among nationally representative survey respondents worried about eviction or foreclosure in November 2020. Among 1,218 study respondents, 128 (12%) reported that they were behind on rent or mortgage payments or didn't know if they could afford the next payment. Just over half (51%) of all participants were women, 46% were 30 to 54 years old, 45% were 55 and older, 69% were White, and 13% each were Black or Hispanic. Of the 128 housing-insecure respondents, 42 (34%) said they were behind on rent or mortgage payments, 55 (38%) said they had little to no confidence that they could afford the next payment, and 31 (28%) reported both. Of all participants, 46% reported moderate to severe psychological distress, and 18% said they were in fair to poor health. Respondents with unstable housing reported more distress (57% vs 45% in housing-secure participants) and poorer health (30% vs 16%).
1st Oct 2021 - CIDRAP

Moderna report says 'human error' to blame for contamination found in 3 vaccine lots from Rovi plant

Five weeks after Japan suspended the use of three lots of the Moderna COVID-19 vaccine, the company and its Japanese distributor Takeda have concluded that “human error” caused the presence of metallic particles in vials. The errors occurred at a Rovi manufacturing plant in Spain, which released three vaccine lots after a fourth lot from the same production series failed an inspection. The fourth and fifth lots from the series were held back, Moderna explained in the 16-page report. Rovi made Moderna aware of the foreign matter when it was discovered. But Rovi incorrectly attributed the contamination to a “vial breakage event,” which happened after the first three lots had been completed.
1st Oct 2021 - FiercePharma

Merck’s antiviral pill reduces hospitalization of Covid patients, a possible game-changer for treatment

An investigational antiviral pill reduced the chances that patients newly diagnosed with Covid-19 would be hospitalized by about 50%, a finding that could give doctors a desperately needed new way to treat the sick, the drug maker Merck announced Friday. A five-day course of molnupiravir, developed by Merck and Ridgeback Biotherapeutics, reduced both hospitalization and death compared to a placebo. In the placebo group, 53 patients, or 14.1%, were hospitalized or died. For those who received the drug, 28, or 7.3%, were hospitalized or died. A simple oral medication to help treat Covid-19 has been an elusive goal since the start of the pandemic. Other drugs, including Gilead’s remdesivir, have also been shown to reduce hospitalizations if given early in the course of disease, but must be given intravenously.
1st Oct 2021 - STAT News

More U.S. parents are willing to vaccinate their children, a survey finds.

A new survey found that more parents were willing to vaccinate their children in mid-September than were willing to do so in July, a shift that coincided with schools reopening in the middle of a wave of hospitalizations and deaths caused by the highly contagious Delta. The latest monthly survey about vaccine attitudes by the Kaiser Family Foundation also found that about one in four U.S. parents reported that a child of theirs had to quarantine at home because of a possible exposure to Covid-19 since the beginning of the school year. That is even as two-thirds of parents say they feel that their school is taking appropriate measures to contain the spread of the coronavirus.
30th Sep 2021 - The New York Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Oct 2021

View this newsletter in full

Coronavirus: Giving children two vaccine doses could prevent thousands of long COVID cases, study suggests

Thousands of long COVID cases in children could be prevented if they are given two vaccine doses, a study suggests. Children between 12 and 15 in the UK are now being offered a single dose of the Pfizer jab to cut their chance of catching the disease and passing it on. But a new study looked at 12-17-year-olds getting both shots and concluded the benefits outweighed the risks "unless case rates are sustainably low". The research, in the Journal of the Royal Society of Medicine, examined rates of hospital admissions, intensive care support, and death among children in England with the virus.
30th Sep 2021 - Sky News

NRx reports positive safety data of Zyesami from Phase III Covid-19 trial

NRx Pharmaceuticals has reported the latest positive safety data from the Phase III ACTIV-3b Critical Care trial of its experimental product, Zyesami (aviptadil) for Covid-19. Sponsored by the National Institutes of Health, the randomised, placebo-controlled ACTIV-3b trial is analysing Zyesami and remdesivir (Veklury) as monotherapy and in combination in hospitalised Covid-19 patients with acute respiratory failure. It enrolled subjects who need high-flow supplemental oxygen delivered by nasal cannula, mechanical ventilation or extracorporeal membrane oxygenation.
30th Sep 2021 - Pharmaceutical Technology

AstraZeneca COVID-19 vaccine shows 74% efficacy in large U.S. trial

AstraZeneca Plc's COVID-19 vaccine demonstrated 74% efficacy at preventing symptomatic disease, a figure that increased to 83.5% in people aged 65 and older, according to long-awaited results of the company's U.S. clinical trial published on Wednesday. Overall efficacy of 74% was lower than the interim 79% figure reported by the British drugmaker in March, a result AstraZeneca revised days later to 76% after a rare public rebuke from health officials that the figure was based on "outdated information.
30th Sep 2021 - Reuters

New Study Finds More Than A Third Of COVID-19 Patients Have Symptoms Months Later

Symptoms of COVID-19 persist or recur months after diagnosis for more than a third of all people who get the illness, a new study finds, potentially pushing the number of so-called long COVID cases higher than previously thought. In the study published Tuesday in the journal PLOS Medicine, researchers found that about 36% of those studied still reported COVID-like symptoms three and six months after diagnosis. Most previous studies have estimated lingering post-COVID symptoms in 10% to 30% of patients. The study, led by University of Oxford scientists in the United Kingdom, searched anonymized data from millions of electronic health records, primarily in the United States, to identify a study group of 273,618 patients with COVID-19 and 114,449 patients with influenza as a control.
30th Sep 2021 - NPR

What Science Knows Now About the Risk of Covid-19 Transmission on Planes

Fliers have yearned for reliable data on the risks of air travel since the pandemic began. Recent research on Covid-19 transmission on flights suggests that airlines could adopt new policies to better protect their passengers. Scientists have found a sharp increase in possible spread during in-flight meal service when everyone has masks off. They’ve also learned more about the importance of precautions during boarding and deplaning. The chances of viral spread aboard planes remain very low. But papers published in medical journals suggest they may not be as low as suggested earlier in the pandemic. “It’s still, at this point, safe to travel if you take proper precautions,” says Mark Gendreau, chief medical officer at Beverly Hospital near Boston and an expert in aviation medicine. “I do think it could be safer.”
30th Sep 2021 - The Wall Street Journal

Am I fully vaccinated without a COVID-19 vaccine booster?

Am I fully vaccinated without a COVID-19 vaccine booster? Yes, people who got a two-dose vaccine or the single-dose Johnson & Johnson shot are considered fully vaccinated — even without a booster. The U.S. Centers for Disease Control and Prevention says you're fully vaccinated two weeks after receiving a second dose of the Pfizer or Moderna vaccine, or one dose of the J&J. The vaccines offer strong protection against serious illness. But U.S. health officials now recommend boosters for some people at higher risk for severe illness from COVID-19 based on evidence that protection against milder disease can wane, especially among older adults.
30th Sep 2021 - The Independent

Regeneron's COVID-19 antibody cocktail pads case for saving lives in hospitalized patients as FDA decision nears

REGEN-COV, a combination of casirivimab and imdevimab, reduced the risk of death by 36% over placebo at Day 29 in hospitalized COVID-19 patients who didn’t require high-flow oxygen or mechanical ventilation when entering the trial, Regeneron unveiled at IDWeek 2021. All patients also received standard-of-care treatments. Regeneron already has a request under FDA review to expand REGEN-COV’s emergency use authorization to cover hospital settings. The two-drug combo is currently authorized for treating certain outpatients and as a post-exposure prophylaxis method to prevent the development of symptomatic COVID-19 in high-risk individuals. The 36% improvement didn’t meet the statistical significance bar. An early stop of the phase 2/3 trial thanks to slow enrollment was partly to blame. The efficacy data came from nearly 1,200 patients, just over a third of the trial size originally planned.
30th Sep 2021 - FiercePharma

Angola Resumes Restrictions as Covid Turns Deadlier Than Malaria

Angola will again close the country’s beaches and other leisure and public-gathering facilities from Oct. 1, a month after they were opened, following a spike in Covid-19 infections. From Oct. 15, access to public services will be subject to proof of vaccination or a negative test. Nearly all citizens 18 years or older will be required to get vaccinated, including pregnant women, state minister Adao de Almeida said in Luanda late Thursday. Angola recorded 14,549 infections and 558 deaths during September. That’s a higher number of deaths than those caused by malaria for first time, health minister Silvia Lutucuta said without providing details for malaria, which is widespread in the nation.
30th Sep 2021 - Bloomberg

Two studies tie long COVID-19 to severe initial illness

Today, in JAMA Network Open, Chinese researchers describe "long COVID" symptoms of fatigue, sweating, chest tightness, anxiety, and muscle pain among 2,433 COVID-19 survivors released from one of two hospitals in Wuhan, China, from Feb 12 to Apr 10, 2020. The team conducted phone interviews and chronic obstructive pulmonary disease (COPD) assessment tests (CATs) with the patients from Mar 1 to Mar 20, 2021. Among 2,433 patients, median age was 60 years, 49.5% were men, 27.9% had survived severe COVID-19, 29.3% had high blood pressure, 45.0% reported having at least one persistent symptom, and 15.8% reported at least three symptoms. The most common symptoms were fatigue (27.7%), sweating (16.9%), chest tightness (13.0%), anxiety (10.4%), and muscle pain (7.9%). While cough, anorexia, and shortness of breath decreased over the year since hospital release, several new symptoms appeared, including heart palpitations (4.2%), swelling of the lower limbs (1.4%), and changes in taste (1.4%) and smell (1.3%).
29th Sep 2021 - CIDRAP

CDC urges COVID-19 vaccination in pregnancy

The Centers for Disease Control and Prevention (CDC) released an official health advisory, encouraging COVID-19 vaccination for pregnant and lactating Americans, as well as those considering pregnancy. According to CDC data, only 3% of pregnant women have been vaccinated against COVID-19, and vaccination rates vary markedly by race and ethnicity. Pregnant Asian Americans have the highest coverage (45.7%), while only 15.6% of Black pregnant women are vaccinated. "Pregnancy can be both a special time and also a stressful time—and pregnancy during a pandemic is an added concern for families," said CDC Director Rochelle Walensky, MD, MPH. "I strongly encourage those who are pregnant or considering pregnancy to talk with their healthcare provider about the protective benefits of the COVID-19 vaccine to keep their babies and themselves safe."
29th Sep 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Sep 2021

View this newsletter in full

Covid: 37% of people have symptoms six months after infection

One in three people infected with coronavirus will experience at least one symptom of long Covid, a new study suggests. Much of the existing research into the condition – a mixture of symptoms reported by people often months after they were originally ill with Covid-19 – has been based either on self-reported symptoms or small studies. Now researchers at the University of Oxford, the National Institute for Health Research (NIHR) and the Oxford Health Biomedical Research Centre (BRC) have shed fresh light on the scale of the problem after studying more than 270,000 people recovering from coronavirus in the US. They found 37% of patients had at least one long Covid symptom diagnosed three to six months after infection. The most common symptoms were breathing problems, abdominal symptoms, fatigue, pain and anxiety or depression.
29th Sep 2021 - The Guardian

Coronavirus can transform pancreas cell function; certain genes may protect an infected person's spouse

Coronavirus transforms pancreas cell function - When the coronavirus infects cells, it not only impairs their activity but can also change their function, new findings suggest. For example, when insulin-producing beta cells in the pancreas become infected with the virus, they not only produce much less insulin than usual, but also start to produce glucose and digestive enzymes, which is not their job, researchers found. "We call this a change of cell fate," said study leader Dr. Shuibing Chen, who described the work in a presentation on Tuesday at the annual meeting of the European Association for the Study of Diabetes, held virtually this year. It is not clear whether the changes are long-lasting, or if they might be reversible, the researchers noted earlier in a report published in Cell Metabolism. Chen noted that some COVID-19 survivors have developed diabetes shortly after infection. "It is definitely worth investigating the rate of new-onset diabetes patients in this COVID-19 pandemic," she said in a statement. Her team has been experimenting with the coronavirus in clusters of cells engineered to create mini-organs, or organoids, that resemble the lungs, liver, intestines, heart and nervous system. Their findings suggest loss of cell fate/function may be happening in lung tissues as well, Chen, from Weill Cornell Medicine in New York, told Reuters.
29th Sep 2021 - Reuters

Merck says research shows its COVID-19 pill works against variants

Laboratory studies show that Merck & Co's experimental oral COVID-19 antiviral drug, molnupiravir, is likely to be effective against known variants of the coronavirus, including the dominant, highly transmissible Delta, the company said on Wednesday. Since molnupiravir does not target the spike protein of the virus - the target of all current COVID-19 vaccines - which defines the differences between the variants, the drug should be equally effective as the virus continues to evolve, said Jay Grobler, head of infectious disease and vaccines at Merck. Molnupiravir instead targets the viral polymerase, an enzyme needed for the virus to make copies of itself. It is designed to work by introducing errors into the genetic code of the virus.
29th Sep 2021 - Reuters on MSN.com

EU to decide on Pfizer booster on Oct. 4 - document

The EU's drugs regulator will decide on Monday whether to approve Pfizer's COVID-19 booster vaccine, but it is unlikely to give precise guidance on who should receive it, according to an internal document and two officials. If the European Medicines Agency (EMA) gives its backing for the jab, the 27-member block would join the United States, Britain and Israel which have already received the green light to deploy boosters, even though there is no consensus among scientists that they are necessary.
29th Sep 2021 - Reuters

Covid-19 Cases Improving in 47 of 50 States

The U.S. recovery from the latest Covid-19 wave is taking hold across the country, with cases dropping or poised to start falling in the vast majority of states. In 47 states plus the nation’s capital, a measure of average new infections from one newly infected person is below the key level of 1, signaling that cases are expected to decline, according to covidestim, a modeling project with contributers from Yale School of Public Health, Harvard’s T.H. Chan School of Public Health and Stanford Medicine.
29th Sep 2021 - Bloomberg

Too slow Sanofi calls time on coronavirus vaccine program

As rivals entrench their lead in the coronavirus vaccine market, French vaccines giant Sanofi has finally called time on its COVID-19 vaccine development programme, arguing there is not room now for a fresh vaccine in a highly active vaccine market place.
29th Sep 2021 - The Pharma Letter

NIAID awards approximately $36.3 million to fuel vaccine research for coronaviruses

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants. The awards are intended to fuel vaccine research for a diverse family of coronaviruses, with a primary focus on potential pandemic-causing coronaviruses, such as SARS-CoV-2. The new awards are funded by NIAID's Division of Microbiology and Infectious Diseases and its Division of Allergy, Immunology, and Transplantation through the Emergency Awards Notice of Special Interest (NOSI) on Pa.n-Coronavirus Vaccine Development Program Projects. The notice was issued in November 2020 while many SARS-CoV-2 vaccines were still under development because a critical need remained for prophylactic vaccines offering broad protective immunity against other coronaviruses, such as Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV).
29th Sep 2021 - News-Medical.Net

Sanofi reports positive Phase I/II interim trial data of Covid-19 vaccine

Sanofi has reported positive interim results from a Phase I/II clinical trial of its messenger ribonucleic acid (mRNA)-based Covid-19 vaccine candidate. These results establish the potential of the lately acquired mRNA and lipid nanoparticle (LNP) platform from Translate Bio and also back Sanofi’s mRNA strategy. According to the preliminary data from the trial, neutralising antibody seroconversion defined as a four-times rise compared to baseline was observed in 91% to 100% of trial subjects two weeks after the second vaccine dose. This trend was noted across all the three dosages tested, Sanofi said. Furthermore, no safety concerns were reported while the tolerability profile was in line with that of other unmodified mRNA Covid-19 vaccines. Sanofi Pasteur Research and Development (R&D) global head Jean-Francois Toussaint said: “We have made an impressive move just nine months after the worldwide proof of concept of mRNA vaccines and only 17 since we started this first mRNA vaccine project.
29th Sep 2021 - Pharmaceutical Technology

COVID-19: Vitamin A nasal drops to be trialled to help restore smell loss

A 12-week trial will look at whether nasal drops can help those who lost their sense of smell after having COVID-19. The "Apollo trial" will treat people who have experienced a loss of smell or altered sense of smell because of coronavirus using vitamin A nasal drops. The University of East Anglia (UEA) said research from Germany has shown the potential benefit of the vitamin, and its team "will explore how this treatment works to help repair tissues in the nose damaged by viruses". They hope the trial "could one day help improve the lives of millions around the world who suffer from smell loss, by returning their fifth sense".
29th Sep 2021 - Sky News

Algeria to start Sinovac COVID-19 vaccine production Wednesday

Algeria will start production of COVID-19 vaccine Sinovac in partnership with China on Wednesday with the aim of meeting domestic demand and exporting the surplus, the prime minister's office said on Tuesday. The government has said production capacity will stand at 1 million, 2 million and 3 million doses in October, November and December respectively, before reaching 5 million doses per month from January. The North African country has been importing vaccines, mainly Sinovac, since the coronavirus pandemic began in March 2020.
29th Sep 2021 - Reuters

Some may have ‘protective version of gene which resists severe Covid-19’ – study

Some people possess a version of a gene which can potentially restrain the virus which causes Covid-19, a study has indicated. The findings offer an explanation for why some people have better natural defences against serious Sars-CoV-2 infection, say scientists. Scientists suggest antiviral responses are better in people who have a more protective “prenylated” version of the OAS1 gene, while others have a version which fails to detect the virus. But if new variants learn to evade the protection offered by the prenylated gene they could become “substantially more pathogenic and transmissible in unvaccinated populations”, say experts.
29th Sep 2021 - Evening Standard

At least one long-term symptom seen in 37% of COVID-19 patients -study

At least one long-term COVID-19 symptom was found in 37% of patients three to six months after they were infected by the virus, a large study from Oxford University and the National Institute for Health Research showed on Wednesday. The most common symptoms included breathing problems, fatigue, pain and anxiety, Oxford University said, after investigating symptoms in over 270,000 people recovering from COVID-19. The symptoms were more frequent among people who had been previously hospitalised with COVID-19 and were slightly more common among women, according to the study.
29th Sep 2021 - Reuters

How COVID-19 can damage all five senses

Considering how sick he was, Michael Goldsmith seemed like one of the lucky ones, because he survived. After becoming severely ill with COVID-19 in March 2020, he spent 22 days on a ventilator in the ICU. Fortunately, Goldsmith’s condition improved, and he was moved to an intermediate level of care in the hospital as he recovered. That’s when he began to realise he had lost most of his hearing in his left ear. “Anything I did hear had to be loud, and then it sounded like Charlie Brown’s teacher,” says Goldsmith, now 35, referencing the nonsensical noises the teacher made in the popular cartoon show. He also had a static sound in that ear that turned out to be tinnitus. After he fully recovered from the infection and went back to his home in Bergenfield, New Jersey, the IT security analyst and father of two saw one doctor after another, seeking relief for his hearing problems. He tried several different prescription medicines, and still he was no better off.
29th Sep 2021 - National Geographic UK

Pfizer vaccine for kids may not be available until November

Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children but the shots may not be available until November. The company said Tuesday it provided health regulators with data from a recent study of its vaccine in children 5 to 11 years old. Officials had said previously they would file an application with the FDA to authorize use in the coming weeks. Once the company files its application, U.S. regulators and public health officials will review the evidence and consult with their advisory committees in public meetings to determine if the shots are safe and effective enough to recommend use.
29th Sep 2021 - The Associated Press

A new study points to the power of wearables to predict even presymptomatic infections, suggesting use one day against Covid-19

A new study that infected willing participants with common cold and flu viruses provides the most rigorous evidence yet that wearable health monitors could predict infections, even before a person starts experiencing symptoms. If the wearables can similarly predict infections in real-world conditions, the technology could add to existing disease surveillance and testing methods. But unresolved issues with standardizing wearables and testing them on diverse populations raise questions about their immediate utility. The new study, published Wednesday in JAMA Network Open, took aim at a research problem that has plagued other efforts to study wearables as infection detectors: small sample size. In two previous studies that looked at wearable devices like Apple Watches and Fitbits, tens of thousands of enrolled individuals corresponded to around 50 cases of Covid-19. In these studies and similar ones, it wasn’t clear when infected people first contracted the virus, further constraining the possibility of making predictions.
29th Sep 2021 - STAT News

Side effect rates from a third Covid-19 vaccine dose similar to those after second shot, early data indicate

People who’ve received a third dose of a Covid-19 vaccine are reporting rates of side effects similar to those after the second dose, according to data released Tuesday by the Centers for Disease Control and Prevention. The new report, published in the Morbidity and Mortality Weekly Report, relies on submissions from thousands of people who received third shots of the mRNA vaccines from Pfizer-BioNTech and Moderna after such doses were authorized for people with compromised immune systems. People submitted their reactions to v-safe, the CDC’s smartphone-based surveillance network. Among more than 12,500 people who completed surveys after each shot, 79.4% of people reported local reactions (including itching, pain, or redness at the injection site), while 74.1% reported systemic reactions (mostly fatigue, muscle aches, and headaches), typically the day after the shot. That compared to 77.6% and 76.5% of the people who reported local or systemic reactions, respectively, after their second shot.
28th Sep 2021 - STAT News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Sep 2021

View this newsletter in full

Sanofi Ends a Covid-19 Vaccine Effort, Saying Market Is Already Well Served

Sanofi SA won’t proceed with the development of one of its experimental Covid-19 vaccines, saying it didn’t make sense to go forward in an already-crowded market. The decision comes despite promising early results for the shot. The French healthcare giant said Tuesday that the vaccine—a so-called mRNA shot that uses the same technology as shots developed by Pfizer Inc. and Moderna Inc. —produced neutralizing antibodies against the virus in early-stage clinical trials. But it said it had decided not to proceed with larger studies, called Phase 3 trials, which would be required to win regulatory approval. Thomas Triomphe, head of Sanofi’s vaccine business, said it didn’t make sense to pursue the mRNA vaccine when the market was already well served. Instead, Sanofi will pivot its mRNA research efforts toward other infectious diseases. It is already conducting early-stage clinical trials on an experimental mRNA shot against flu.
28th Sep 2021 - The Wall Street Journal

South Africa, Oxfam call for fairer trade rules in response to pandemic

South Africa's president and the head of Oxfam heaped pressure on World Trade Organization members and manufacturers to allow fairer access to COVID-19 vaccines on Tuesday, including through a waiver on intellectual property rights. At a WTO public event on trade and COVID-19 also attended by German vaccine maker BioNTech, Cyril Ramaphosa said a waiver on patents was needed to save millions of lives during the pandemic,
28th Sep 2021 - Reuters

FOCUS-COVID-19 pill developers aim to top Merck, Pfizer efforts

As Merck & Co and Pfizer Inc prepare to report clinical trial results for experimental COVID-19 antiviral pills, rivals are lining up with what they hope will prove to be more potent and convenient oral treatments of their own. Enanta Pharmaceuticals, Pardes Biosciences, Japan's Shionogi & Co Ltd and Novartis AG said they have designed antivirals that specifically target the coronavirus while aiming to avoid potential shortcomings such as the need for multiple pills per day or known safety issues. Infectious disease experts stressed that preventing COVID-19 through wide use of vaccines remains the best way to control the pandemic. But they said the disease is here to stay and more convenient treatments are needed
28th Sep 2021 - YAHOO!Finance

Brazil to give COVID-19 booster shots to people over 60 years old

Brazil will provide COVID-19 vaccine booster shots to all its people over 60-years-old, Health Minister Marcelo Queiroga said on Tuesday. Queiroga said in a tweet that the decision comes in line with progress in the country's vaccination program. About 7 million Brazilians could get the booster shot under these conditions, he said. Brazil had already started giving booster shots to people over 70-years-old and healthcare workers. According to Health Ministry data, about 600,000 booster shots have been administered up to now.
28th Sep 2021 - Reuters

Pfizer submits data for COVID-19 vaccine use in younger kids

Pfizer Inc and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in 5-11 year olds and said they would make a formal request to U.S. regulators for emergency use in the coming weeks. The U.S. Food and Drug Administration said earlier this month it would look to complete its data review for this age group as quickly as possible, likely in a matter of weeks rather than months. That could mean an authorization of the shot for children by the end of October, sources have told Reuters.
28th Sep 2021 - Reuters

India allows Serum Institute to enrol 7-11 year olds in COVID-19 vaccine trial

India's drug regulator on Tuesday allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its trial of U.S. drugmaker Novavax's COVID-19 vaccine, as the country prepares to protect children from the novel coronavirus. The South Asian nation has already administered more than 870 million doses to adults among its population of nearly 1.4 billion.
28th Sep 2021 - Reuters

Early data shows ButanVac vaccine induces potent immune response

Developed by the Sao Paulo-based Butantan Biological Institute, the ButanVac coronavirus vaccine showed " an acceptable safety profile and potent immunogenicity" in clinical trials held in Thailand. The study showed that there were "no vaccine-related serious adverse events." The vaccine is also being tested in Brazil and Vietnam, but trial data from the two countries have not been made available so far.
28th Sep 2021 - The Brazilian Report

Half of young people willing to get Covid jab - study

Half of children and young people aged nine to 18 are willing or eager to be vaccinated against Covid, a large survey in England suggests. It is one of the first polls to ask pupils, rather than parents, their views on teenage Covid jabs. Carried out during the summer term, the responses from more than 27,000 students at 180 schools reveal half would opt to get protected. More than a third were undecided and just over one in 10 would decline. The findings, published in the journal EClinicalMedicine, were carried out before the UK recommended all children aged 12 to 15 should be offered one dose of the Pfizer/BioNTech Covid jab.
28th Sep 2021 - BBC News

COVID-19 pill developers aim to top Merck, Pfizer efforts

A pill to treat Covid-19: 'We're talking about a return to, maybe, normal life'

Within a day of testing positive for covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, was having trouble breathing, symptoms serious enough to send her to the emergency room. When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: "I thought, 'I hope to God we don't wind up on ventilators. We have children. Who's going to raise these kids?" But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutch cancer research center that's part of an international effort to test an antiviral treatment that could halt covid early in its course.
28th Sep 2021 - CNN

Pfizer/BioNTech submit initial data on Covid-19 vaccine for people ages 5 to 11 to FDA, but aren't seeking EUA yet

Pfizer and BioNTech said Tuesday they have submitted Covid-19 vaccine data on children ages 5 to 11 to the US Food and Drug Administration for initial review, but are not yet seeking emergency use authorization. A formal submission to request EUA for the vaccine is expected to follow in the coming weeks, the companies said in a statement. Submissions to the European Medicines Agency and other regulatory authorities are also planned, they said. This is the first submission of data to the FDA for a Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.
28th Sep 2021 - CNN

Pfizer Submits Favorable Initial Data To The FDA On Kids' COVID-19 Vaccine Trial

Pfizer and BioNTech are another step closer to seeking authorization for young children to receive the COVID-19 coronavirus vaccine, submitting data to the Food and Drug Administration that shows a "robust" antibody response and "favorable" safety outcomes in kids ages 5 to 11 who received the two-dose regimen in clinical trials. The companies plan to submit a formal request for emergency-use authorization of the vaccine for that age range "in the coming weeks," they said Tuesday. News of the data submission comes a week after Pfizer announced promising results from the trials, which have been closely watched by parents eager to protect their children from the coronavirus. COVID-19 has now killed more than 690,000 people in the U.S., with millions more sickened by the disease.
28th Sep 2021 - NPR

Smokers up to 80% more likely to be admitted to hospital with Covid, study says

Smokers are 60%-80% more likely to be admitted to hospital with Covid-19 and also more likely to die from the disease, data suggests. A study, which pooled observational and genetic data on smoking and Covid-19 to strengthen the evidence base, contradicts research published at the start of the pandemic suggesting that smoking might help to protect against the virus. This was later retracted after it was discovered that some of the paper’s authors had financial links to the tobacco industry.
28th Sep 2021 - The Guardian

Sanofi ditches mRNA COVID-19 vaccine after rivals' success

Sanofi is dropping plans for its own mRNA-based COVID-19 vaccine because of the dominance achieved by BioNTech-Pfizer and Moderna in using the technology to fight the pandemic, the company said on Tuesday. The move highlights the challenges of competing in particular with pioneer BioNTech, which rose from obscurity through its alliance with pharma major Pfizer last year. They have delivered close to 1.5 billion doses so far to become the Western world's largest COVID-19 vaccine maker.
28th Sep 2021 - Reuters

COVID-19: One in 10 secondary school pupils with coronavirus suffered ongoing symptoms, ONS research finds

More than one in 10 secondary school students and over a third of school staff who have had COVID-19 have suffered ongoing symptoms, new research has found. Staff and pupils commonly reported weakness and tiredness, while staff were more likely to experience shortness of breath, according to a small study of schools in England. The Office of National Statistics (ONS) estimates that 35.7% of staff and 12.3% of students, who previously tested positive for COVID-19, reported experiencing ongoing symptoms more than a month after contracting the virus.
28th Sep 2021 - Sky News

Covid-19 may stay with us forever

The major problem is that the rise of more infectious strains of Sars-CoV-2 have quashed hopes of herd immunity, even in countries with high vaccine uptake. Scientists such as Francois Balloux, who directs the UCL Genetics Institute, say that this outcome was inevitable as soon as Covid-19 became a truly global pandemic. “I believe the opportunity for global eradication was gone very, very early in the pandemic,” says Balloux. “You can eliminate it locally, but as long as there’s a focus somewhere in the world, whether that’s Iran, Afghanistan, Somalia, it will eventually come back. As of February 2020, it was clear that elimination would not be possible.”
28th Sep 2021 - Wired.co.uk

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Sep 2021

View this newsletter in full

EU reviewing data on Moderna's COVID-19 booster shot

Pfizer Inc said on Monday it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus. The drugmaker and its rivals, including U.S.-based Merck & Co Inc and Swiss pharmaceutical Roche Holding AG, have been racing to develop an easy-to-administer antiviral pill for COVID-19
27th Sep 2021 - Reuters

Pfizer begins study of oral drug for prevention of COVID-19

Covid: New Delta mutation found in Italy can be beaten by vaccines, study suggests

An outbreak of a new strain of coronavirus among card-playing pensioners in northern Italy suggests it may not threaten vaccines as much as scientists fear. Public health chiefs are monitoring the strain – a combination of the highly infectious Delta variant and the E484K mutation associated with vaccine evasion – which has been identified in 19 people in the UK and a further 99 around the world. The strain is not yet a variant of concern due to the small numbers, but scientists are concerned it could take off as more people are vaccinated, which creates conditions for strains that can dodge vaccines.
27th Sep 2021 - iNews

Alberta's former chief medical officer of health calls for 'urgent' COVID-19 change

Alberta Premier Jason Kenney rejected calls for a "hard lockdown" during an appearance on a radio program Sunday, the same day that his province's former top doctor signed a letter calling for immediate "firebreak" measures to deal with surging cases of COVID-19. Kenney told radio host Roy Green that a lockdown would make "no sense for the 80 per cent of the population that is vaccinated," who he said are much less likely to transmit the disease and are far less likely to be hospitalized. He also said the roughly 20 per cent who aren't vaccinated and are behind the surge in cases are less likely to follow public health measures. Dr. James Talbot, Alberta's former chief medical officer of health, co-wrote a letter to the province's new health minister, Jason Copping, strongly recommending additional measures in the province, as the pandemic's fourth wave continues to strain hospital capacity.
27th Sep 2021 - CBC.ca

Covid-19: Aussie doctors reveal why your next vaccination shot is going up your nose

Scientists are working on a nasal spray vaccine for Covid-19. 'You are 11 times more likely to die from Covid if you are unvaccinated.' The nose and mouth are the doorways to getting the virus. Getting vaccinated significantly reduces the risk of being infected
27th Sep 2021 - Daily Mail

Japan approves GSK's Sotrovimab COVID-19 antibody treatment

Japan has approved GlaxoSmithKline and Vir Biotechnology's Sotrovimab as an antibody treatment for coronavirus, Health Minister Norihisa Tamura said on Monday. The antibody treatment is for mild to moderate COVID-19 cases which do not require oxygen supplementation, GSK said when it applied for fast-track approval this month.
27th Sep 2021 - Reuters

Small study shows antibody growth from AstraZeneca, Sputnik Light COVID-19 vaccine mix

A small-scale clinical study of the combined use of the AstraZeneca and Sputnik Light vaccines against COVID-19 has shown strong antibody growth in a majority of the study's participants, the Russian Direct Investment Fund said on Monday. The data was collected from 20 people who took part in a 100-person study in Azerbaijan that began in February. They first received the AstraZeneca shot followed by the one-dose Russian-made Sputnik Light shot 29 days later, RDIF said.
27th Sep 2021 - Reuters

Covid-19: England sees biggest fall in life expectancy since records began in wake of pandemic

The covid-19 pandemic led to the biggest year-on-year drop in life expectancy in England since statistics were first collected in 1981, Public Health England has said. In 2020, the agency said that “the very high level” of excess deaths because of the pandemic caused life expectancy in England to fall 1.3 years for men to 78.7 and 0.9 years for women to 82.7. This was the lowest life expectancy in England for both sexes since 2011. Not all countries have reported life expectancy data for 2020 yet. But of those that have, PHE noted that Italy, Poland, and Spain experienced similar decreases in life expectancy to England in 2020, while France had a smaller decrease. Germany had little or no relative excess mortality in men or women. The US and Poland had the highest relative excess mortality in 2020, in both men and women.
27th Sep 2021 - The BMJ

COVID-19: Llama nanobodies may offer new treatment

Although vaccines are highly effective in preventing COVID-19, scientists still need to identify better treatments for the disease. Some scientists are investigating whether llama-derived antibodies might be a useful treatment approach. A recent study has shown that so-called nanobodies that scientists harvested from a llama reduced SARS-CoV-2 viral load in Syrian hamsters.
27th Sep 2021 - Medical News Today

Venezuelan academy of medicine expresses concern over use of Cuban vaccine

Venezuela’s National Academy of Medicine on Monday expressed concern over the use of Cuba’s Abdala coronavirus vaccine due to a lack of scientific research on its safety and efficacy. Cuba said on Saturday it had exported the three-shot vaccine for the first time, sending an initial shipment to Vietnam as part of a contract to supply five million doses to the Southeast Asian country. The government of Venezuelan President Nicolas Maduro has so far been relying on the Russian Sputnik V and the Chinese Sinopharm vaccines, and in recent months received its first shipment of doses via the global COVAX program.
27th Sep 2021 - Reuters

WHO backs Regeneron drug for COVID-19, urges action on price

The World Health Organisation (WHO) has added the Regeneron antibody drug cocktail – casirivimab and imdevimab – to its list of treatments for people with COVID-19, urging the manufacturer to reduce the price and ensure equitable distribution. Clinical studies showed the drug combination was effective in patients who were not severely ill but at high risk of being admitted to hospital with COVID-19, or those with severe cases of the disease and no existing antibodies, the WHO said in a statement on Friday.
24th Sep 2021 - AlJazeera

WHO adds new recommendation for COVID-19 monoclonal antibody combo

The WHO's conditional recommendation for the monoclonal antibody cocktail, which consists of casirimivab and imdevimab, applies to patients with nonsevere COVID-19 who are at high risk for hospitalization and for people who have severe and critical infections who have no antibodies to SARS-COV-2. In November, the US Food and Drug Administration issued an emergency use authorization for the drug combination for adults and kids ages 12 and older who have mild- to moderate COVID-19. The combination is administered through intravenous (IV) infusion or injection. It made headlines when it was used to treat former President Donald Trump's COVID-19 infection. Demand for the treatment has been skyrocketing in US hot spots such as Florida, where officials have opened state-run centers to deliver the treatment. As a result, the Biden administration recently took steps to address shortages by taking over distribution and buying 1.4 million more doses. In the United States, the drug costs about $1,250 per dose and is covered by the federal government.
24th Sep 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Sep 2021

View this newsletter in full

Behind Covid-19 Booster Authorization Were Disagreements on Evidence, Broad Access

The Biden administration publicly touted its plan to roll out Covid-19 boosters to almost all the fully vaccinated during the week of Sept. 20, saying data from Israel supported the approach. Yet behind the scenes, federal regulators tasked with clearing boosters and recommending who should get them were locked in a pitched battle over whether the data supported the plan, according to people familiar with the matter. Some regulators argued that only certain vulnerable groups such as seniors needed an additional shot and that the decision-making timeline was too rushed, the people said. The dissenters also bristled at the Biden administration’s declaration, in August, that boosters would be widely available if authorized by the Food and Drug Administration and recommended by the Centers for Disease Control and Prevention, arguing it put pressure on the agencies to follow the announced course, the people said.
25th Sep 2021 - The Wall Street Journal

Since Covid-19 Hit, Research on Viruses Has Exploded. Is it Safe?

Laboratories around the globe increasingly are experimenting with emerging viruses, sometimes giving them new capabilities, as they seek to identify dangerous ones and find ways to combat them. While the goal is to protect health, some of the projects carry the chance of a misstep that could unleash an epidemic, some scientists say. Experiments in the U.S. are reviewed in advance by researchers’ institutions or government funders, but risky projects can go forward without being subjected to the highest level of scrutiny, especially in some other countries. Some scientists and officials in the Biden administration are pushing for more oversight, globally, of risky bioresearch. One focus is laboratory work that enhances a pathogen or endows it with new properties—sometimes called “gain-of-function” research—which is often done to assess its potential to infect humans.
25th Sep 2021 - The Wall Street Journal

Schools without mask mandate 3.5 times more likely to have COVID-19 outbreaks: CDC study

A Centers for Disease Control and Prevention (CDC) study found that schools in two Arizona counties that didn’t require universal masking were 3.5 times more likely to endure COVID-19 outbreaks than schools with mask mandates. Out of the 191 schools in Maricopa and Pima counties that experienced outbreaks by the end of August, 59.2 percent did not have a mask requirement, compared to 8.4 percent that required masks from the start of the school year. Almost a third of outbreaks occurred in schools that implemented mask mandates after the school year began.
25th Sep 2021 - The Hill

Pfizer in talks over full license for COVID-19 vaccine in Singapore

Pfizer Inc is in discussions with Singapore's Health Sciences Authority regarding obtaining a full license application for its COVID-19 vaccine, the company said in response to a query from Reuters. Pfizer-BioNTech's COVID-19 vaccine has interim authorisation under the pandemic special access route in Singapore. The U.S. Food and Drug Administration granted full approval to the vaccine last month. Kenneth Mak, Singapore's director of medical services, said in a briefing on Friday Pfizer and Moderna had not submitted applications for full registration to authorities.
25th Sep 2021 - Reuters

Even Mild Cases of COVID May Leave a Mark on the Brain

With more than 18 months of the pandemic in the rearview mirror, researchers have been steadily gathering new and important insights into the effects of COVID-19 on the body and brain. These findings are raising concerns about the long-term impacts that the coronavirus might have on biological processes such as aging. As a cognitive neuroscientist, my past research has focused on understanding how normal brain changes related to aging affect people’s ability to think and move – particularly in middle age and beyond. But as more evidence came in showing that COVID-19 could affect the body and brain for months or longer following infection, my research team became interested in exploring how it might also impact the natural process of aging.
25th Sep 2021 - Scientific American

It Took Years to Reach Vaccine Warp Speed

The story begins on Sept. 18, 2001—a week after 9/11—when the New York Post, NBC News and other media organizations received letters containing military-grade anthrax bacteria. Three weeks later, similar letters arrived at the offices of Sens. Tom Daschle and Patrick Leahy. Congress responded to this very direct threat by enacting the Bioterrorism Act of 2002, the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006. That last law established the Biomedical Advanced Research and Development Authority, or Barda, an agency within the Department of Health and Human Services. Barda reports to the HHS’s assistant secretary of preparedness and response (the position Dr. Kadlec held during the Trump administration). Its mission is to facilitate the development of new medical products that would enable preparedness and respond to threats.
24th Sep 2021 - The Wall Street Journal

A daily pill to treat Covid could be just months away, scientists say

Within a day of testing positive for Covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, was having trouble breathing, symptoms serious enough to send her to the emergency room. When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: “I thought: ‘I hope to God we don’t wind up on ventilators. We have children. Who’s going to raise these kids?’” But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutchinson Cancer Research Center that’s part of an international effort to test an antiviral treatment that could halt Covid early in its course.
24th Sep 2021 - NBC News

Children, covid-19, and India's looming third wave

Makepeace Sitlhou reports on how covid-19 has affected children in India, and how the authorities are making plans to improve provision of care In September 2020, 15 year old Well Done Boy Marbaniang was brought to hospital in Shillong, India, with fever, cough, and breathing difficulties. He was immediately put on non-invasive ventilation and given intravenous fluids, but just five and a half hours after his admission, Marbaniang died. He was the first child to die of covid-19 in Meghalaya. The northeastern state had the highest case fatality rate (8.3%) in India during the first wave of covid-19, and one of the highest rates of positive test results (7-8% against the national average of 2.5%) during the second wave. Around 22% of total infections through to August were in under 18s.
24th Sep 2021 - The BMJ

C.D.C. Chief Overrules Agency Panel and Endorses Pfizer Boosters for Frontline Workers

The director of the Centers for Disease Control and Prevention on Friday overruled a recommendation by an agency advisory panel that had refused to endorse booster shots of the Pfizer-BioNTech Covid vaccine for frontline workers. It was a highly unusual move for the director, Dr. Rochelle Walensky, but aligned C.D.C. policy with the Food and Drug Administration’s endorsements over her own agency’s advisers. The C.D.C.’s Advisory Committee on Immunization Practices on Thursday recommended the boosters for a wide range of Americans, including tens of millions of older adults and younger people at high risk for the disease. But they excluded health care workers, teachers and others whose jobs put them at risk. That put their recommendations at odds with the F.D.A.’s authorization of booster shots for all adults with a high occupational risk.
24th Sep 2021 - The New York Times

Biden tells 60 million Americans to get booster shots after CDC director overruled advisers

Biden urged Americans over 65 and with certain medical conditions or jobs to get booster shots. 'I'll be getting my booster shot,' said Biden, 78. Frontline workers and those with medical conditions like diabetes are encouraged to get jabs under new CDC guidance. CDC Director Rochelle Walensky intervened to expand eligibility
24th Sep 2021 - Daily Mail

Moderna CEO Stéphane Bancel says vaccines can end pandemic in one year

Moderna’s chief executive says that the coronavirus pandemic could be over in a year and that a boost in production will mean enough vaccines for “everyone on this Earth” by then. More booster shots should be available, too, to some extent, and even babies will be able to get vaccines, Stéphane Bancel told a Swiss newspaper in an interview published Thursday. Asked whether that could spell “a return to normal” next year, he replied: “As of today, in a year, I assume.” With the vaccine industry as a whole expanding production, “enough doses should be available by the middle of next year so that everyone on this Earth can be vaccinated,” the French billionaire said.
23rd Sep 2021 - The Washington Post

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Sep 2021

View this newsletter in full

Does My Mask Protect Me if Nobody Else Is Wearing One?

There is also plenty of evidence showing that masks protect the wearer even when others around them are mask-free. The amount of protection depends on the quality of the mask and how well it fits. During a hotel outbreak in Switzerland, for instance, several employees and a guest who tested positive for the coronavirus were wearing only face shields (with no masks); those who wore masks were not infected. And a Tennessee study found that communities with mask mandates had lower hospitalization rates than areas where masks weren’t required.
23rd Sep 2021 - The New York Times

Covid-19 Vaccines Can Be Updated for the Delta Variant. Here’s How.

Scientists are working to develop shots that would target the Delta variant specifically. The mRNA platform behind some vaccines might make this process relatively straightforward, according to Matthew Johnson, senior director of product development at the Duke Human Vaccine Institute. Vaccines work by exposing the body to a harmless version or portion of a virus. This teaches our immune systems to recognize and fight the real virus if our bodies become infected with it. The mRNA-based vaccines developed for Covid-19—including the two made by Moderna Inc. and by Pfizer Inc. and partner BioNTech SE —rely on the outer spike proteins of the new coronavirus to prime our immune defenses. Spike proteins stud the outer surface of the virus and help it latch onto and infect healthy cells.
23rd Sep 2021 - The Wall Street Journal

Novavax applies to WHO for emergency listing of COVID-19 vaccine

Novavax and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing of Novavax's COVID-19 vaccine, potentially clearing the way for the shot to ship to many poorer countries, the company said on Thursday. Novavax has been prioritizing regulatory submissions to low- and middle-income countries after falling behind in the race for authorization in the United States and Europe, which have already vaccinated most of their residents.
23rd Sep 2021 - Reuters

EU drugs regulator says to decide on Pfizer vaccine booster in early October

The European Medicines Agency (EMA) aims to decide in early October whether to endorse a third dose of the Pfizer-BioNTech, COVID-19 vaccine to be given half a year after the initial two-shot course, saying breakthrough infections added some urgency to its review. "The outcome of this evaluation is expected in early October, unless supplementary information is needed," EMA's head of vaccines strategy, Marco Cavaleri, told a press briefing on Thursday. Cavaleri's statement confirmed a Reuters report earlier in the day on EMA's expected review time on the matter
23rd Sep 2021 - Reuters

The Vaccinated Aren't ‘Just as Likely’ to Spread COVID

For many fully vaccinated Americans, the Delta surge spoiled what should’ve been a glorious summer. Those who had cast their masks aside months ago were asked to dust them off. Many are still taking no chances. Some have even returned to all the same precautions they took before getting their shots, including avoiding the company of other fully vaccinated people.
23rd Sep 2021 - The Atlantic

Coronavirus unlikely to become more deadly because it’s run out of ‘places to go’, says Oxford jab creator

Covid is unlikely to mutate into a deadlier, vaccine-evading, variant because it’s run out of “places to go” , the creator of the Oxford jab has said. Dame Sarah Gilbert said coronavirus is likely to become less severe in its effects. Speaking at a Royal Society of Medicine webinar on Wednesday, she said: “We normally see that viruses become less virulent as they circulate more easily and there is no reason to think we will have a more virulent version of Sars-CoV-2.” Dame Sarah said that some variations were to be expected but predicted that coronavirus would eventually become like the flu virus, saying: “What tends to happen over time is there’s just a slow drift, that’s what happens with flu viruses. You see small changes accumulating over a period of time and then we have the opportunity to react to that.”
23rd Sep 2021 - The Independent

Oxford researchers find Llama antibodies have “significant potential” as potent Covid-19 treatment

A unique type of tiny antibody produced by llamas could provide a new frontline treatment against Covid-19 that can be taken by patients as a simple nasal spray. Research led by scientists at the Rosalind Franklin Institute in Oxford has shown that nanobodies – a smaller, simple form of antibody generated by llamas and camels – can effectively target the SARS-CoV-2 virus that causes Covid-19. They found that short chains of the molecules, which can be produced in large quantities in the laboratory, significantly reduced signs of the Covid-19 disease when administered to infected animals. The nanobodies, which bind tightly to the SARS-CoV-2 virus, neutralising it in cell culture, could provide a cheaper and easier to use alternative to human antibodies taken from patients who have recovered from Covid-19.
23rd Sep 2021 - ITV News

Beijing Wantai plans large trial for nasal spray COVID-19 vaccine candidate

Chinese vaccine developer Beijing Wantai Biological Pharmacy Enterprise plans to start a large trial for its nasal spray-based COVID-19 vaccine candidate next month, a clinical trial registration record showed. The company aims to recruit 40,000 adult participants for the Phase III clinical trial, according to an entry posted on the Chinese Clinical Trial Registry on Wednesday
23rd Sep 2021 - Reuters

New Zealand's strategy to eliminate Covid-19 faces defeat by Delta strain, admits health chief

New Zealand’s strategy to eliminate the coronavirus may have been defeated by the Delta strain, the country’s health chief has conceded. With the country’s largest city, Auckland, in lockdown since mid-August, the health director-general Dr Ashley Bloomfield has warned that the nation may not return to zero Covid-19 cases. Jacinda Ardern, the prime minister, has previously committed to elimination of the virus despite the view of her Australian counterpart, Scott Morrison, that this goal was “absurd”.
23rd Sep 2021 - The Times

Valneva expands trials on COVID-19 vaccine candidate

French vaccine maker Valneva (VLS.PA) is expanding trials of a COVID-19 vaccine candidate called VLA2001, and remains in talks with the European Commission over a potential contract, the company said on Thursday. Valneva shares plunged 42% after Britain said on Sept 13 that it cancelled its contract for about 100 million doses of the vaccine the company is developing, partly over concerns about when it would win approval for use.
23rd Sep 2021 - Reuters

Covid-19: Abnormalities in the womb detected among pregnant women even after they tested negative

Analysis of 115 women in the UK, Canada and France who gave birth over the last 18 months showed far more physical abnormalities in the placenta than doctors would expect to see in a pre-2020 pregnancy. The pandemic is taking a physical toll on pregnant women – even if they do not catch Covid-19, a small international study suggests. Analysis of 115 women in the UK, Canada and France who gave birth over the last 18 months showed far more physical abnormalities in the placenta than doctors would expect to see in a pre-pandemic pregnancy. Rates of problems with the placenta, the baby’s support system in the womb, tripled among expectant mothers with Covid-19 but doubled even among those who tested negative, suggesting the changes can be caused by the sheer stress of the pandemic as well as the virus itself.
23rd Sep 2021 - iNews

Heart inflammation after COVID-19 vaccine: Are boys at higher risk?

A new, non-peer-reviewed study concluded that healthy boys aged 12–17 years had a higher hospitalization rate due to heart inflammation after their second mRNA COVID-19 vaccination than the expected hospitalization rate for COVID-19 in that age group. A non-peer-reviewed study reports on scientific research that other experts in the field have not evaluated before publication; it should not guide clinical decision-making. In the case of this paper, there are several issues with the data that the researchers used, which limits the accuracy and applicability of the study’s findings. A CDC analysis of reports of heart inflammation after COVID-19 vaccines is currently under review at a major peer-reviewed journal.
23rd Sep 2021 - Medical News Today

‘Covid-19 will become like common cold’ by next spring, say experts who claim worst of pandemic is over

Covid-19 could soon resemble the common cold as the virus weakens and people’s immunity is boosted by vaccines and exposure, two leading experts have said. Professor Sir John Bell, regius professor of medicine at Oxford University, has claimed the coronavirus could become like a cold by as soon as next spring. He also claimed the UK “is over the worst” of the pandemic and things “should be fine” once winter has passed.
23rd Sep 2021 - iNews

‘I Know Who Caused Covid-19’ review – the global blame game

t’s not surprising that Covid-19 has made people angry: their lives have become disrupted in unimaginable ways. People have lost family members to the disease, or suffered for months with long Covid. With the restrictions needed to keep health services afloat, small businesses have gone under, city centres have been shuttered and people have spent months without seeing loved ones. Basic freedoms that we took for granted were taken away in order to stop the spread of a dangerous virus. The questions of where it came from, and just who is responsible for all this devastation and loss, have assumed outsize importance.
23rd Sep 2021 - The Guardian

EU drugs regulator to decide on Pfizer vaccine booster in early October

The European Medicines Agency aims to decide in early October whether to endorse a third dose of the Pfizer-BioNTech, COVID-19 vaccine to be given half a year after the initial two-shot course, saying breakthrough infections added some urgency to its review. "The outcome of this evaluation is expected in early October, unless supplementary information is needed," EMA's head of vaccines strategy, Marco Cavaleri, told a press briefing.
23rd Sep 2021 - Reuters

U.S. CDC advisers back COVID-19 booster shots for those 65 and older, not for high-risk workers

A U.S. Centers for Disease Control and Prevention (CDC) advisory panel on Thursday recommended a booster shot of the Pfizer and BioNTech COVID-19 vaccine for Americans aged 65 and older and some adults with underlying medical conditions that put them at risk of severe disease.
23rd Sep 2021 - Reuters

4DMedical lung imagery sheds more light on 'long COVID' effects

The scans by 4DMedical allow physicians to detect areas of high and low lung ventilation using existing equipment in hospitals, said founder and Chief Executive Andreas Fouras. The 'four dimensions' refers to the scan's ability to measure the phases of breath as it passes into and out of the lungs. "It takes a short video sequence. We use about 20 seconds worth of video sequence of the patient just breathing naturally," said Fouras. "From that video sequence, we're able to mathematically calculate the motion and then the airflow everywhere around the lungs."
23rd Sep 2021 - Reuters

EU drugs regulator to decide on Pfizer vaccine booster in early October

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Sep 2021

View this newsletter in full

Moderna vs. Pfizer: Both Knockouts, but One Seems to Have the Edge

Roughly 221 million doses of the Pfizer-BioNTech vaccine have been dispensed thus far in the United States, compared with about 150 million doses of Moderna’s vaccine. In a half-dozen studies published over the past few weeks, Moderna’s vaccine appeared to be more protective than the Pfizer-BioNTech vaccine in the months after immunization. The latest such study, published on Wednesday in The New England Journal of Medicine, evaluated the real-world effectiveness of the vaccines at preventing symptomatic illness in about 5,000 health care workers in 25 states. The study found that the Pfizer-BioNTech vaccine had an effectiveness of 88.8 percent, compared with Moderna’s 96.3 percent.
22nd Sep 2021 - The New York Times

Pfizer Study of Covid-19 Vaccine in Pregnant Women Delayed by Slow Enrollment

Changing guidelines and the possibility of being given a placebo made the trial unappealing to some expectant mothers. fizer closed enrollment at many U.S. sites this summer, after fewer than expected numbers of subjects entered the study, researchers say. The slow enrollment was driven by revised guidelines from government and physician groups that recommend pregnant women receive the shots based on new real-world research, according to trial-site researchers. They also say increased vaccine supply made a trial that included the possibility of being given a placebo instead of a vaccine unappealing to expectant mothers and raised questions about the ethics of seeking volunteers.
22nd Sep 2021 - The Wall Street Journal

Coronavirus: China seeks to develop next-gen vaccines amid trial complications

A lack of international cooperation to compare vaccines will make it more difficult for China to come up with convincing data for future vaccines using new technologies or targeting new variants of Covid-19, although China is not alone, experts said. China is developing several second generation vaccines using either inactivated vaccine technology, mRNA or protein subunit technologies. It is also developing first generation vaccines using mRNA technology. China needed to conduct phase 3 clinical trials for its early first generation vaccines overseas because there were not enough Covid-19 cases domestically. However, finding places for clinical trials for second generation vaccines, which target specific variants or a broad spectrum of variants, has become increasingly difficult because it would be considered unethical to deliver placebos in controlled trials where transmissions are high, particularly as other vaccines are available.
22nd Sep 2021 - South China Morning Post

Covishield: UK recognises Covid jab after India outcry

The UK government has amended its foreign travel guidance to clarify that the Indian-made version of the AstraZeneca vaccine is an approved jab. But it is not clear whether people from India can travel to the UK without having to self-isolate for 10 days. The UK's refusal to recognise Covishield had triggered a firestorm of protests in India. With more than 721 million doses administered so far, Covishield is India's primary vaccine. On Tuesday, India described the rule as "discriminatory" and asked the UK to stop requiring fully-vaccinated Indians to self-isolate on arrival. At present, India is not listed as a country where people are recognised as fully vaccinated even if they've had both doses of an approved jab.
22nd Sep 2021 - BBC News

Llama antibodies have 'significant potential' for Covid-19 treatment

Tiny antibodies produced by llamas could provide a new frontline treatment against coronavirus in the form of a nasal spray, research suggests. Scientists at the Rosalind Franklin Institute have found that the nanobodies – a smaller, simple form of antibody generated by llamas and camels – can effectively target the Sars-CoV-2 virus that causes Covid-19. Short chains of the molecules, which can be produced in large quantities in the laboratory, significantly reduced signs of Covid-19 when given to infected animal models, according to the study. The nanobodies bind tightly to the virus, neutralising it in the laboratory, and could provide a cheaper and easier alternative to human antibodies taken from recovered from Covid-19 patients.
22nd Sep 2021 - Metro.co.uk

Between Covid-19 and the flu, health care professionals are bracing themselves for the winter ahead, expert says

The current pace in Covid-19 vaccinations is the slowest it has been since July, according to data released Wednesday from the Centers for Disease Control and Prevention. The latest data comes as flu season is around the corner, which could increase death tolls and put more of a strain on hospitals that are already struggling with an influx of patients and depleted resources. More than 312,000 people have initiated the vaccination process -- or getting their first shot -- over the last week, CDC data shows. That's a 7% drop from last week and a 35% drop from the previous month. An average of 742,703 doses are being administered each day and about 182 million people, or 54.9%, of the US population, are fully vaccinated, the data shows. That leaves 71 million people, or 25.1% of the population, who are not vaccinated
22nd Sep 2021 - CNN

Covid-19 vaccines for teenagers: conversations and consent

On 13 September, the UK chief medical officers recommended that all 12-15 year olds be offered a single dose of Pfizer-BioNTech covid-19 vaccine.1 This followed a previous recommendation by the Joint Committee on Vaccination and Immunisation2 not to offer covid-19 vaccines to healthy 12-15 year olds. The UK now joins a growing list of countries offering vaccination to those aged 12 and over, but it is providing only one dose rather than the two given in other countries because of concerns about rare side effects such as heart inflammation. The health benefits of covid-19 vaccination are small in this age group since covid-19 infection is not a serious threat to their health.5 However, the chief medical officers’ decision was influenced by the wider benefit of reducing further disruption to education. Parents are understandably concerned about vaccine safety. It’s not yet clear how schools and healthcare professionals will cope with delivering up to 2.6 million covid-19 vaccines, answering parents’ questions,6 and supporting teenagers to make informed decisions.
22nd Sep 2021 - The BMJ

CDC panel tackles who needs booster shot of COVID vaccine

An influential panel of advisers to the Centers for the Disease Control and Prevention grappled Wednesday with the question of which Americans should get COVID-19 booster shots, with some members wondering if the decision should be put off for a month in hopes of more evidence. The doubts and uncertainties suggested yet again that the matter of whether to dispense extra doses to shore up Americans’ protection against the coronavirus is more complicated scientifically than the Biden administration may have realized when it outlined plans a month ago for an across-the-board rollout of boosters. The rollout was supposed to have begun this week.
22nd Sep 2021 - The Associated Press

Has the Delta variant changed the symptoms of COVID-19?

It has been said many times that the arrival of the Delta variant of the coronavirus has changed the course of the pandemic. It is more transmissible than previous variants and has quickly become the dominant variant across the world. And because the vaccines are less effective against it, although still effective enough, it has brought the need for booster shots to the forefront of the debate. A new study has shown that the symptoms that the infection presents have also changed. According to the World Health Organization, the most common symptoms of COVID are...
22nd Sep 2021 - AlJazeera

Trials begin on Covid booster jab hoped to protect against new variants

The first trials have begun of a Covid booster jab that it is hoped will offer good protection against a wide range of variants, researchers have revealed. Covid jabs currently used in the UK trigger an immune response towards the coronavirus spike protein, which helps the virus get into human cells. However, different variants of the coronavirus have different mutations in this protein, meaning a vaccine that works well against one variant may not be as effective against another. The team behind the new booster jab hope to get around this problem by triggering an immune response towards the spike and non-spike proteins of the coronavirus.
21st Sep 2021 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Sep 2021

View this newsletter in full

J&J Says Covid-19 Vaccine Booster Two Months After First Shot Increases Protection

Johnson & Johnson said a booster dose of its Covid-19 vaccine administered two months after the first shot increased protection against symptomatic illness in trial participants, as federal regulators evaluate data for the country’s strategy for rolling out boosters. Data released Tuesday from a late-stage clinical trial showed that study participants in 10 countries including the U.S. who received a second dose of the company’s vaccine two months after the first had 75% protection against symptomatic Covid-19. Participants in the U.S. had 94% protection against the illness. J&J didn’t explain the reason for the difference in efficacy rates.
21st Sep 2021 - The Wall Street Journal

J&J says second shot boosts protection for moderate-severe COVID-19 to 94%

Johnson & Johnson said Tuesday a second shot of its COVID-19 vaccine given about two months after the first increased its effectiveness to 94% in the United States against moderate to severe forms of the disease.
21st Sep 2021 - Reuters on MSN.com

Johnson & Johnson Says Its Booster Shot Provides Increased Protection From COVID-19

People who receive a Johnson & Johnson COVID-19 vaccine booster shot are better protected against the coronavirus for a longer period of time, according to the pharmaceutical company's latest trial results. The one-dose Johnson & Johnson vaccine has been found to be 66% protective against moderate and severe disease overall worldwide and 72% protective against such cases in the U.S. But when a person receives a booster shot two months after getting the pharmaceutical company's one-dose vaccine, the protection against COVID-19 increased to 94%. A booster shot at six months provided a 12-fold increase in antibodies.
21st Sep 2021 - NPR

Covid-19: Monoclonal antibody treatment to be rolled out to hospital patients with no antibody response

Eligible patients with covid-19 in UK hospitals who have not mounted an antibody response against SARS-CoV-2 will be offered the monoclonal antibody treatment ronapreve from this week, the government has announced. The drug is a combination of two monoclonal antibodies (casirivimab and imdevimab), which work by binding to two different sites on the SARS-CoV-2 spike protein and neutralising the virus’s ability to infect cells. It was the first neutralising antibody drug specifically designed to treat covid-19 approved by the Medicines and Healthcare Products Regulatory Agency (in August 2021). Ronapreve will be administered to patients without antibodies—who must be either aged 50 or over, or aged 12 to 49 and considered to be immunocompromised—through a drip. The government said it had secured enough supply for NHS patients across the four nations and that antibody testing will be used to determine which patients are eligible.
21st Sep 2021 - The BMJ

Trials begin on new vaccine to fight Covid-19 variants

Trials are under way in Manchester of a new jab to fight Covid-19 variants in the hope it can offer longer-lasting immunity than current vaccines. Initially involving participants aged 60 and over, its creators hope the new drug – GRT-R910 – can boost the immune response of first-generation Covid-19 vaccines to a wide array of variants of Sars-Cov-2, which cause Covid-19. First to receive the trial jabs were retired NHS nurse Helen Clarke, 64, and her husband Andrew, 63, from Bolton, Greater Manchester. Mrs Clarke said: “I used to work in the NHS and had been involved in research as a nurse in the past.
21st Sep 2021 - Evening Standard

Covid-19: How is vaccination affecting hospital admissions and deaths?

An analysis of UK data from the National Immunisation Management Service (NIMS) and the Coronavirus Clinical Information Network (CO-CIN),1 endorsed by the UK Scientific and Advisory Group for Emergencies (SAGE),2 shows that of 40 000 patients with covid-19 who were admitted to hospital between December 2020 and July 2021 a total of 33 496 (84%) had not been vaccinated. It found that 5198 (13%) of these patients had received their first vaccine and 1274 (3%) their second. A total of 611 patients with previous covid-19 (reinfection) were not included in the analysis.
21st Sep 2021 - The BMJ

HSJ Patient Safety Awards 2021: Covid-19 Infection Prevention and Control Award

Northern Care Alliance Group: Covid-19 Rapid Antigen Testing Using LFDs in Emergency Departments to Aid Infection Prevention & Control – Northern Care Alliance at the Vanguard. During the second wave of the pandemic, demand for PCR testing exceeded capacity and adversely affected patient management. At that time (November 2020), UK policy did not support deployment of lateral flow devices for covid. Northern Care Alliance NHS Group introduced LFD for patients needing admission through emergency departments. An LFD (SD Biosensor) was introduced in the ED by pathology. Significant improvement in patient flow and reduction in nosocomial transmissions was a testimony to its clinical utility. The alliance presented at the National Virology Cell meeting and by late December 2020, the government launched its use for all ED admissions.
21st Sep 2021 - Health Service Journal

Brazil and Argentina tapped to make mRNA vaccines in Latin America

The Pan American Health Organization has selected two biomedical centers in Argentina and Brazil as regional hubs to develop and produce mRNA-based vaccines to fight COVID-19 in Latin America, the regional health agency said on Tuesday. The idea is to tap existing manufacturing capacities to help transfer vaccine technology developed by Moderna in the United States to a region badly hit by the coronavirus and still without access to enough vaccines.
21st Sep 2021 - Reuters

J&J: Booster dose of its COVID shot prompts strong response

J&J said in statement that an extra dose — given either two months or six months after the initial shot — revved up protection. The results haven’t yet been published or vetted by other scientists. The J&J vaccine was considered an important tool in fighting the pandemic because it requires only one shot. But even as rollout began in the U.S. and elsewhere, the company already was running a global test of whether a two-dose course might be more effective — the second dose given 56 days after the first. That two-dose approach was 75% effective globally at preventing moderate to severe COVID-19, and 95% effective in the U.S. alone, the company reported — a difference likely due to which variants were circulating in different countries during the months long study.
21st Sep 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Sep 2021

View this newsletter in full

Regulators could OK Pfizer boosters for older Americans this week

U.S. regulators could authorize a booster shot of the Pfizer Inc/BioNTech SE COVID-19 vaccine for older and some high-risk Americans early this week in time for the government to roll them out by Friday. The Food and Drug Administration is expected to give the nod to the third shots for at least this group before advisers to the U.S. Centers for Disease Control and Prevention are due to meet on Wednesday. The CDC panel will discuss more precise recommendations for how to administer the shots.
20th Sep 2021 - Reuters

Pfizer, BioNTech Say Covid-19 Vaccine Is Safe for Children Aged 5 to 11

The companies said the Covid-19 vaccine generated levels of antibodies that were similar to those of younger adults. Pfizer will seek emergency use authorization in the U.S. as early as the end of the month.
20th Sep 2021 - The Wall Street Journal

Covid Vaccine for Kids Age 5-11 Likely Available by Halloween, Fauci Says

The U.S. death toll from the Covid-19 pandemic surpassed the number of fatalities in the 1918 influenza pandemic, a milestone many experts say was avoidable after the arrival of vaccines. The White House announced the most sweeping change to U.S. travel policies in months, widening the gap in rules between vaccinated people -- who will see curbs relaxed -- and the unvaccinated. Ther regulations will replace existing bans on foreigners’ travel to the U.S. from certain regions, including Europe. Pfizer Inc. and partner BioNTech SE said their vaccine was safe and produced strong antibody responses in younger children in a large-scale trial. The shot may be available by the end of next month, Anthony Fauci said.
20th Sep 2021 - Bloomberg

Pfizer Vaccine Safe for 5 to 11 Year Olds, Large Trial Finds

Pfizer Inc. and partner BioNTech SE said their Covid-19 vaccine was safe and produced strong antibody responses in children ages 5 to 11 in a large-scale trial, findings that could pave the way to begin vaccinating grade-school kids within months. The long-awaited results offer one of the first looks at how well a Covid vaccine could work for younger children. Pressure to immunize kids has been on the climb in the U.S., where a new school year has started just as the delta variant is fueling a surge in cases.
20th Sep 2021 - Bloomberg

Though lagging behind, Israel’s COVID-19 jab hopes to ‘find its place in market’

Nearly two years after the emergence of the COVID-19 pandemic, Israel may soon finally see its own homegrown vaccine become commercially available. The jab will be a very late newcomer — lagging behind the first wave of COVID vaccines by almost a year — but its backers believe that it will find its rightful place in the global vaccine market, and may even prove in the long run to be more effective than existing jabs against coronavirus variants. These beliefs were offered this month by Dr. Jonathan Javitt, chairman of NRx Pharmaceuticals, the American-Israeli clinical-stage pharmaceutical company tapped two months ago by the Israeli Defense Ministry to manufacture and market the country’s vaccine developed by the government-run Israel Institute for Biological Research (IIBR) in Ness Ziona.
20th Sep 2021 - The Times of Israel

COVID-19: Pfizer-BioNTech vaccine trial for children aged under 12 shows 'robust immune response'

A Pfizer-BioNTech COVID-19 vaccine trial for children aged between five and 11 has produced "positive results" and has shown a "robust immune response", the two firms have said. They said the results are the first to emerge from any vaccine trial for children aged below 12 and would "provide a strong foundation" for seeking the authorisation of its potential rollout across the world. Pfizer and BioNTech said the data will be submitted to health regulatory bodies and that they believe the trial provides a "great opportunity" to prevent COVID-19 in younger age groups.
20th Sep 2021 - Sky News

Cambodia bat researchers on mission to track origin of COVID-19

Researchers are collecting samples from bats in northern Cambodia in a bid to understand the coronavirus pandemic, returning to a region where a very similar virus was found in the animals a decade ago. Two samples from horseshoe bats were collected in 2010 in Stung Treng province near Laos and kept in freezers at the Institut Pasteur du Cambodge (IPC) in Phnom Penh. Tests done on them last year revealed a close relative to the coronavirus that has killed more than 4.6 million people worldwide.
20th Sep 2021 - Reuters

COVID-19 antibody drug Ronapreve rolled out to vulnerable patients

Thousands of vulnerable NHS patients in hospital due to COVID-19 are set to benefit from a ground-breaking new antibody treatment Ronapreve. The drug is the first neutralising antibody medicine specifically designed to treat COVID-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK. Ronapreve, a combination of two monoclonal antibodies, will be targeted initially at those in hospital who have not mounted an antibody response against COVID-19. This includes people who are immunocompromised, for example those with certain cancers or autoimmune diseases, and therefore have difficulty building up an antibody response to the virus, either through being exposed to COVID-19 or from vaccination.
20th Sep 2021 - Pharmafield

Key data on U.S. J&J, Moderna COVID-19 boosters weeks away, Fauci says

Data needed to determine the advisability of booster shots of the Moderna Inc and Johnson & Johnson COVID-19 vaccines is just weeks away, President Joe Biden's chief medical adviser, Dr. Anthony Fauci, said on Sunday. Health officials signaled they expected boosters would ultimately be recommended for a broad swath of the population, but urged Americans not to seek booster doses until they have FDA approval. "We recommend that people wait until you get to the point where you fall into the category where it's recommended," he told CNN.
20th Sep 2021 - Reuters

Winter is coming, again: What to expect from Covid-19 in the new season

“We’re experiencing a new virus, a newly emerged pathogen, and we’re trying to fight it with new tools that we don’t have a lot of experience with,” he said. “And we’re dealing with unpredictable human behavior … which is a very important factor as well, and environmental factors that may influence the severity of Covid outbreaks and how well it transmits.” “There’s a lot of moving parts,” said Duchin, who is also an infectious diseases professor at the University of Washington. Among them: the questions of when Covid vaccines will be approved for use in children and what percentage of parents will agree to vaccinate their kids. While the crystal ball may be cloudy, who can resist taking a peek? Let’s talk about some things we might face in the months ahead.
20th Sep 2021 - STAT News

The search for antivirals for covid-19

Antivirals are one of the most sought after, yet missing, tools to control SARS-COV-2. Chris Stokel-Walker asks what was learnt from a similar search nearly 20 years ago Antiviral drugs are among the most researched tools for treating covid-19. They either prevent a virus entering a host cell or prevent it from being able to replicate once it is inside. And yet, over 18 months into the pandemic, finding ones that are effective against SARS-CoV-2 has proved challenging. Remdesivir was an early frontrunner—and many governments were desperate enough to grant it emergency use approval despite limited evidence. Those early hopes were ultimately dashed when major studies, notably the World Health Organization’s Solidarity trial, found it to be ineffective at preventing death (although it did help patients already recovering do so marginally faster). Doctors in Japan have treated covid-19 patients with favipiravir, an influenza antiviral, but the drug has previously been linked to birth defects
20th Sep 2021 - The BMJ

Pfizer Covid-19 vaccine generates robust antibody response in children, without serious safety issues, company says

Pfizer and its partner BioNTech said Monday that they would file for authorization of their Covid-19 vaccine for use in children after clinical trial results showed encouraging antibody levels in volunteers and side effects similar to those in teens and young adults. The pediatric study, in children ages 5 to 11, is the first to disclose results in young children. It used a lower dose of the vaccine than the one currently being administered, because earlier studies showed that the adult dose could cause more side effects. Adults receive two 30 microgram doses of the vaccine three weeks apart. In school-aged children, this was lowered to 10 micrograms.
20th Sep 2021 - STAT News

‘I felt this huge relief’: how antibody injections could free the immunosuppressed under Covid

But as with so many other simple pleasures in the age of Covid-19, nothing is that simple for Brown. The 47-year-old Missouri resident takes immunosuppressant medication for lupus. Consequently, her body has mounted virtually no antibody response to the coronavirus vaccine – leaving her in persistent peril. Brown is among the estimated 3% of American adults who have immunosuppression, including transplant recipients and people with cancer and autoimmune disorders such as lupus.
19th Sep 2021 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Sep 2021

View this newsletter in full

Fauci Says More Data Likely to Support Broader U.S. Booster Plan

President Joe Biden’s chief medical adviser said booster shots for more of the U.S. population remain a possibility soon, as additional data on the still-widening outbreak come in. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, spoke two days after an advisory panel to the U.S. Food and Drug Administration rejected a national rollout of boosters for all ages, approving them only for people 65 and older and those who are medically vulnerable. “The story is not over because more and more data is coming in and will be coming in,” Fauci said Sunday on ABC’s “This Week.”
19th Sep 2021 - Bloomberg

COVID-19: Top scientist says ministers should have improved PCR testing system rather than 'abandoning it entirely'

A top scientist who advises the government says ministers should have improved the COVID testing system for international travel rather than "abandoning it entirely". Professor Stephen Reicher, a member of the Scientific Pandemic Insights Group on Behaviours, which feeds into the Scientific Advisory Group for Emergencies (SAGE), said the removal of the need for a PCR COVID test will impact on the UK's ability to spot dangerous infections coming into the UK.
19th Sep 2021 - Sky News

Fauci: FDA vote against Covid booster shots ‘not the end of the story’

A decision not to recommend third-shot booster vaccinations for most Americans is “not the end of the story”, White House chief medical adviser Dr Anthony Fauci insisted on Sunday, two days after a scientific panel appeared to turn the Biden administration’s plan for combating coronavirus on its head. Fauci also said he did not believe a million coronavirus deaths in the US was an inevitability, despite the Delta variant-fuelled surge that last week brought the grim milestone of one in 500 Americans having fallen victim to the pandemic. The near-unanimous vote on Friday by scientific advisers to the US Food and Drug Administration (FDA) to recommend against a routine third shot of the Pfizer vaccine was seen as a rebuke to Joe Biden, who announced the “third jab strategy” as a main plank of his six-pronged anti-Covid plan.
19th Sep 2021 - The Guardian

Bats in Laos Caves Harbor Closest Relatives to Covid-19 Virus

Bats dwelling in limestone caves in northern Laos were found to carry coronaviruses that share a key feature with SARS-CoV-2, moving scientists closer to pinpointing the cause of Covid-19. Researchers at France’s Pasteur Institute and the University of Laos looked for viruses similar to the one that causes Covid among hundreds of horseshoe bats. They found three with closely matched receptor binding domains -- the part of the coronavirus’s spike protein used to bind to human ACE-2, the enzyme it targets to cause an infection. The finding, reported in a paper released Friday that’s under consideration for publication by a Nature journal, shows that viruses closely related to SARS-CoV-2 exist in nature, including in several Rhinolophus, or horseshoe bat, species.
19th Sep 2021 - Bloomberg

Vietnam approves Abdala vaccine as president visits Cuba

Vietnam has approved Cuba's Abdala vaccine for use against the new coronavirus, the government said, as the Southeast Asian country is battling its worst outbreak. Abdala becomes the eighth COVID-19 vaccine approved for use in Vietnam, which has one of the lowest vaccination rates in the region, with only 6.3% of its 98 million people having received at least two shots. The announcement came hours after President Nguyen Xuan Phuc left Hanoi for an official visit to Havana.
18th Sep 2021 - Reuters

Children should know about tiny risk from Covid vaccine, insist experts

Children need to understand the tiny potential risk of life-threatening heart problems before having a coronavirus vaccine, key government advisers are urging. Professor Adam Finn, a member of the Joint Committee on Vaccination and Immunisation, says that in normal times, the vaccine would not have been recommended for widespread use in children until the long-term consequences of rare side effects had been fully investigated. Parents are justified in waiting until the risks are clearer before getting their teenagers vaccinated and the NHS needs to spell out the uncertainty over long-term effects better, he argues. He fears that if some children eventually suffer lifelong health risks without being told of known concerns, trust in other vaccination programmes and wider government health advice will suffer
18th Sep 2021 - The Times

FDA advisers recommend COVID boosters for 65 and older after rejecting broad approval

Advisers to the U.S. Food and Drug Administration voted to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval. The panel also recommended that the FDA include healthcare workers and others at high risk of occupational exposure to the virus that causes COVID-19, such as teachers. Despite the narrowed scope of the proposed authorization, the panel's recommendation would cover most Americans who got their shots in the earliest stages of the U.S. vaccination campaign.
18th Sep 2021 - Reuters

COVID-19: QCovid tool's new algorithm identifies those most at-risk from coronavirus after vaccination

A tool to calculate a person's risk from COVID-19 has been updated to include who could be susceptible to serious complications, even if they have been fully vaccinated. It found that the elderly, men and people from certain ethnic minorities were most likely to end up in hospital or die due to the coronavirus. Last year, the team behind the QCovid tool used data from more than 6 million people to design an algorithm which could predict COVID outcomes. Now, the analysis of 6.9 million people who received two shots of the vaccine allows for a prediction of who may be more susceptible even after their inoculations.
18th Sep 2021 - Sky News

COVID-19: Trial will see if children need second jab - with 12 to 16-year-olds getting different combinations in study

Youngsters aged 12-16 are to be offered a mix of coronavirus vaccines in a new trial to determine whether children need a second jab and if so which type would be most effective. It comes after health leaders approved first doses of the Pfizer vaccine for over-12s on Monday. Researchers from the University of Oxford are carrying out the trial which will analyse how the participants respond to various combinations. Those involved in the study will all receive a full dose of the Pfizer jab initially.
17th Sep 2021 - Sky News

South Korea approves Celltrion's COVID-19 treatment for use

South Korea approved Celltrion's antibody COVID-19 treatment for infected adults in high-risk groups or those with severe symptoms. Phase III clinical trials showed that the treatment significantly reduced deterioration of COVID-19 symptoms to severe levels and shortened recovery, the Ministry of Food and Drug Safety said in a statement. The treatment lowered the rate of high-risk patients developing severe symptoms by 72% and shortened recovery by 4.12 days, the ministry said.
17th Sep 2021 - Reuters

How COVID-19 hybrid immunity could be a potential pandemic game-changer

With the FDA gearing up to decide if all Americans need booster shots, some researchers are pointing to preliminary data suggesting that mixing different vaccines could offer an even stronger immune boost. For now, data is too sparse to support a mix-and-match strategy, experts say. But scientists are learning more about just how strong the immune response can be for someone who has previously been infected with COVID-19 then gets the vaccine -- a phenomenon called "hybrid immunity." "The best thing we can hope for is that three vaccine doses will emulate the super immune response, found among those previously infected with the virus," said Dr. Paul Goepfert, an infectious disease physician and director of the Alabama Vaccine Research Clinic. "This [type of immunity] will protect against variants in the future."
17th Sep 2021 - ABC news

Investigating COVID-19's hidden death toll

The official COVID-19 mortality count in the United States has surpassed 660,000, but inaccuracies in cause of death reports hide the true impact of the pandemic. Researchers at Boston University and the University of Pennsylvania recently explored healthcare factors at the county level that explained why 20% of excess deaths in 2020 were due to COVID-19. Their study found that most of these excess deaths occurred in areas affected by racial and social injustices.
17th Sep 2021 - Medical News Today

Covid-19: How Native Americans led the way in the US vaccination effort

Data from the US CDC show that Native American groups—American Indians and Alaska Natives—have consistently had the best vaccination records since covid-19 vaccination in the US began in early 2021. The CDC’s daily tracker for 13 September showed that 47.5% of American Indians and Alaska Natives were fully vaccinated.1 This compared with 41.8% of Asians, 37.8% of white Americans, and 29.9% of African Americans. The American Indian/Alaska Native group has maintained its lead since the beginning of vaccination in the first dose category as well. Community leaders ascribe this success to two things: first, the US government’s decision to allow Native American communities to control vaccine distribution; and second, traditional ethnic values including respect for elders, “community first” philosophies, and a willingness to trust science—so long as it’s presented by community members themselves.
17th Sep 2021 - The BMJ

Experts, COVID vaccine firms detail ways to scale up fair distribution

After a meeting with vaccine company executives, a multilateral group dedicated to improving global access to COVID-19 vaccines called on countries and manufacturers to urgently take several steps to ensure that 40% of the population in all countries is vaccinated by the end of the year. In other global developments, UNICEF urged countries to reopen schools as soon as possible to avoid further impacts on kids and economies.
16th Sep 2021 - CIDRAP

Studies show good COVID booster effect, waning 2nd-dose protection

Several new studies on the Pfizer/BioNTech mRNA COVID-19 vaccine describe good effectiveness against the Delta (B1617.2) variant after a booster dose and high but waning protection against infection and severe illness 6 months after the second dose. Other, much smaller, studies demonstrated the safety of third mRNA vaccine doses. And a new British study on waning two-dose effectiveness coincides with the recent decision by UK officials to recommend booster doses.
16th Sep 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Sep 2021

View this newsletter in full

British study to test mixed COVID-19 vaccine dose schedules in children

A British study will look into the immune responses of children to mixed schedules of different COVID-19 vaccines as officials try to determine the best approach to second doses in adolescents given a small risk of heart inflammation. Children aged 12-15 in Britain will be vaccinated from next week, while those aged 16-17 have been eligible for shots since August.
17th Sep 2021 - Reuters UK

COVID-19 booster vaccine campaign begins in England

England launched its COVID-19 booster vaccination campaign on Thursday, the National Health Service (NHS) said, after officials and the government gave the go-ahead for the programme earlier in the week. British Prime Minister Boris Johnson on Tuesday outlined how the booster programme for over-50s and other priority groups will form a key plank of his plan to navigate the winter without further coronavirus lockdowns
16th Sep 2021 - Reuters

Pfizer and Moderna say Covid-19 vaccine protection wanes over time

Pfizer and Moderna said protection from their Covid-19 vaccines can wane over time, as the US drug regulator prepares to consider whether to approve a booster programme. Ahead of a crucial meeting of the Food and Drug Administration vaccines advisory committee on Friday to discuss its booster proposal, Pfizer on Wednesday submitted a study by Kaiser Permanente Southern California suggesting that vaccine efficacy wanes over time naturally, “irrespective of variant”, rather than as a consequence of the Delta coronavirus strain evading its jab.
16th Sep 2021 - The Financial Times

WHO Suspends Sputnik V Approval Process Over Manufacturing Breaches

The World Health Organization (WHO) has suspended its approval process for Russia’s Sputnik V coronavirus vaccine, pending a fresh inspection of at least one Russian factory manufacturing the shot. Speaking at a press briefing of the Pan American Health Organization, a regional branch of the WHO, Assistant Director Jarbas Barbosa said Russia’s bid for emergency authorization had been put on hold after a number of manufacturing infringements were uncovered during a WHO inspection in Russia in May.
16th Sep 2021 - The Moscow Times

Indonesia aims to become a global vaccine manufacturing hub

Health Minister Budi Gunadi Sadikin said the country is well placed to join South. Africa in being one of the WHO’s vaccine ‘technology transfer hubs.’ He said Indonesian pharmaceutical companies are also in talks with vaccine manufacturers and developers
16th Sep 2021 - South China Morning Post

US to buy additional doses of Lilly’s Covid-19 antibody therapies

The US Government is to purchase additional doses of Eli Lilly’s neutralising antibody therapies authorised for emergency use to treat Covid-19. As per the deal, Lilly will deliver 388,000 doses of etesevimab to complement doses of bamlanivimab already purchased by the US government.
16th Sep 2021 - Pharmaceutical Technology

Researchers examine the persistent effects of COVID-19 on vascular function of young adults

In a first-of-its-kind study, researchers have examined the persistent effects of SARS-CoV-2 infection on the vascular function of otherwise healthy young adults. The research, published in the American Journal of Physiology-Heart and Circulatory Physiology, was chosen as an APSselect article for September. “It is intriguing that those with persistent [COVID-19] symptoms exhibited peripheral vascular dysfunction, whereas those who were asymptomatic at the time of testing had similar macrovascular and microvascular vasodilation to controls.”
16th Sep 2021 - News Medical

Menstrual changes after covid-19 vaccination

Common side effects of covid-19 vaccination listed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) include a sore arm, fever, fatigue, and myalgia. Changes to periods and unexpected vaginal bleeding are not listed, but primary care clinicians and those working in reproductive health are increasingly approached by people who have experienced these events shortly after vaccination. More than 30 000 reports of these events had been made to MHRA’s yellow card surveillance scheme for adverse drug reactions by 2 September 2021, across all covid-19 vaccines currently offered.
16th Sep 2021 - The BMJ

Analysis: Hospital strain to test UK's vaccine-based winter COVID plan

British Prime Minister Boris Johnson is hoping to get through winter without any more coronavirus lockdowns, but doctors and scientists warn that relying largely on vaccines without other measures could put unsustainable pressure on hospitals. Britain has recorded one of the highest COVID death tolls in the world for its population size and one of the deepest recessions of wealthy nations as a result of the pandemic, but also has one of the world's highest vaccination rates.
16th Sep 2021 - Reuters UK

Can kids be harmed wearing masks to protect against COVID?

Can kids be harmed wearing masks to protect against COVID? No, there is no scientific evidence showing masks cause harm to kids’ health despite baseless claims suggesting otherwise. The claims are circulating on social media and elsewhere just as virus outbreaks are hitting many reopened U.S. schools — particularly those without mask mandates. Among the unfounded arguments: Masks can foster germs if they become moist or cause unhealthy levels of carbon dioxide. But experts say washing masks routinely keeps them safe and clean.
16th Sep 2021 - The Associated Press

FDA strikes cautious tone ahead of vaccine booster meeting

Influential government advisers will debate Friday if there’s enough proof that a booster dose of Pfizer’s COVID-19 vaccine is safe and effective — the first step toward deciding which Americans need one and when. The Food and Drug Administration on Wednesday posted much of the evidence its advisory panel will consider. The agency struck a decidedly neutral tone on the rationale for boosters — an unusual and careful approach that’s all the more striking after President Joe Biden and his top health advisers trumpeted a booster campaign they hoped to begin next week.
16th Sep 2021 - The Associated Press

As Pfizer's booster AdComm nears, FDA staffers say COVID vaccines are already working as intended

Ahead of the FDA's advisory meeting to review Pfizer's COVID-19 booster application, agency staffers voiced skepticism about the need to quickly roll out follow-up shots. As it stands, authorized vaccines are doing their job, the staffers said. In briefing documents ahead of Friday's meeting, FDA reviewers said that while "some observational studies" suggest the efficacy of Pfizer two-dose vaccine wanes over time, overall data "indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States." The FDA's Vaccines and Related Biological Products Advisory Committee plans to review the data Friday and make recommendations to the agency. The White House has said it plans to start giving COVID-19 booster doses during the week of Sept. 20, pending regulatory nods.
16th Sep 2021 - FiercePharma

Study: Farmworkers at 4 times risk of COVID-19

A study today in JAMA Network Open that found quadruple the risk of COVID-19 in California farmworkers reveals risk factors for current or previous SARS-CoV-2 infection in the group, including outdoor work exposures, crowded living conditions, and high body mass index (BMI). A team led by University of California at Berkeley researchers analyzed the data of 1,107 adult farmworkers undergoing testing for COVID-19 infection and immunoglobulin G (IgG) antibodies at federally qualified community clinics and community sites in the Salinas Valley from Jul 16 to Nov 30, 2020.
16th Sep 2021 - CIDRAP

Almost 90% of all 16-24 year olds now have Covid antibodies, official data suggests

Between 87 and 89 per cent of youngsters across the UK have Covid antibodies This suggests they have some protection against the virus from infection or jab Antibody positivity is 'increasing steadily across all four UK countries', ONS said
16th Sep 2021 - Daily Mail

No-fridge coronavirus vaccine looks promising: study

A team based at University of California, San Diego is working on a coronavirus vaccine that doesn’t need to be refrigerated. They grew plant and bacteria viruses and attached a piece of the spike protein from the SARS-CoV-2 virus. In tests with mice, the vaccine led to high levels of neutralizing antibodies.
15th Sep 2021 - The Hill

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Sep 2021

View this newsletter in full

CDC Advisers Set Meeting for Next Week on Covid Booster Shots

Advisers to the Centers for Disease Control and Prevention will hold a two-day meeting next week to discuss booster shots for Covid-19 vaccines. The Advisory Committee on Immunization Practices posted notice of the meeting, which will be held Sept. 22-23, on its website on Wednesday. The panel of outside experts advises the CDC on how best to administer new vaccines.
15th Sep 2021 - Bloomberg

Why the Delta Variant Is Giving More Children Covid

Covid-19 cases among children are surging across the world amid delta-fueled outbreaks, spurring hospitalizations and raising concern about the risk of severe illness and persistent “long hauler” symptoms. It’s also prompted questions about the safety of schools.
15th Sep 2021 - Bloomberg

Booster Dose Slashes Rates of Covid Infection in Israeli Study

A third dose of the Pfizer Inc.-BioNTech SE Covid vaccine can dramatically reduce rates of Covid-related illness in people 60 and older, according to data from a short-term study in Israel. Starting 12 days after the extra dose, confirmed infection rates were 11 times lower in the booster group compared with a group that got the standard two doses, the analysis released Wednesday by the New England Journal of Medicine found. Rates of severe illness were almost 20 times lower in the booster group.
15th Sep 2021 - Bloomberg

Pfizer (PFE) Says Covid-19 Vaccine Efficacy Erodes Over Time

Pfizer Inc. said that data from the U.S. and Israel suggest that the efficacy of its Covid-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants. The company detailed the data in a presentation it will deliver to a meeting of outside advisers to the Food and Drug Administration on Friday. The panel is expected to make recommendations for whether more Americans should receive booster shots.
15th Sep 2021 - Bloomberg

FDA Says Covid-19 Vaccines Remain Effective Without Boosters

The Food and Drug Administration said vaccines cleared in the U.S. currently provide sufficient protection against severe disease and death from Covid-19 without additional doses, potentially complicating the Biden administration’s deliberations over the need for booster shots. The FDA released the findings Wednesday in a report analyzing data submitted by Pfizer Inc. and BioNTech SE as part of their request for authorization for their vaccine to be given as a booster shot in people 16 years and older. An outside panel of scientific advisers will review the FDA report on Friday, along with a companion analysis from Pfizer and other information, as part of a discussion over who needs booster shots and when.
15th Sep 2021 - Wall Street Journal

Russia's Sputnik V vaccine shows 97.2% COVID-19 efficacy in Belarus - RDIF

Russia's Sputnik V vaccine has demonstrated 97.2% efficacy against COVID-19 during the vaccination campaign in Belarus, Russia's RDIF sovereign wealth fund said on Wednesday.
15th Sep 2021 - Reuters

Single-Dose Sputnik Light Approved For Phase 3 Bridging Trials In India

The single-dose COVID-19 vaccine Sputnik Light received approval from the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) today to conduct phase 3 bridging trials in India.Last year, Hyderabad-based Dr Reddy's Laboratories had partnered with the Russian Direct Investment Fund (RDIF) to conduct phase 3 trials of the vaccine. After the company submitted safety, immunogenicity and efficacy data, the SEC granted permission for conducting the trials in India, a statement by the Central Drugs Standard Control Organisation said.
15th Sep 2021 - NDTV

CureVac scales back mRNA manufacturing for coronavirus vaccine

CureVac, the German biotech once seen as a leading mRNA vaccine developer alongside Moderna and Pfizer, on Tuesday said it will scale back manufacturing plans for its coronavirus shot in Europe. The company attributed the downsizing to "reduced short-term peak demand for vaccines following the first wave of the pandemic vaccination efforts" as well as "corresponding changes in the demand of its first-generation COVID-19 vaccine candidate." As a result, manufacturing contracts with Wacker and Celonic will be terminated. Other manufacturing agreements with Rentschler Biopharma and Novartis are not affected. CureVac is still awaiting a decision from the European Medicines Agency on approval of its first-generation vaccine. Last month, the company reportedly dropped plans to seek a clearance in the U.S. from the Food and Drug Administration.
15th Sep 2021 - BioPharma Dive

U.S. buys additional doses of Eli Lilly, Regeneron COVID-19 therapy

Eli Lilly and Company said on Wednesday the U.S. government bought 388,000 additional doses of its COVID-19 antibody therapy, as infections surge due to the fast-spreading Delta variant. The news comes after Regeneron Pharmaceuticals Inc said late on Tuesday the U.S. government was buying 1.4 million additional doses of its COVID-19 antibody cocktail, REGEN-COV.
15th Sep 2021 - Reuters

Covid-19: Boys are more at risk of myocarditis after vaccination than of hospital admission for covid

The risk of 12-15 year old healthy boys experiencing cardiac adverse events such as myocarditis after their second dose of the Pfizer and BioNTech vaccine is around four times adolescents’ risk of being admitted to hospital as a result of infection with SARS-CoV-2, a preprint study has found. The retrospective study, which has not yet been peer reviewed, used the US vaccine adverse reporting system (VAERS) to identify the rate of post-vaccination myocarditis among 12-15 and 16-17 year olds between January and June 2021 after the second dose of the Pfizer-BioNTech vaccine. The researchers concluded that the rate of cardiac adverse events after the second dose exceeded the expected rate of 120 day covid-19 hospital admission at both a moderate (August 2021) and a high (January 2021) incidence of SARS-CoV-2 infection.
15th Sep 2021 - The BMJ

U.K. Sidelines Homegrown Astra Vaccine in mRNA Booster Push

Britain will roll out a Covid vaccine booster campaign next week in which the homegrown shot from AstraZeneca Plc and the University of Oxford will hardly feature at all. Instead, the U.K. government is relying on shots from Pfizer Inc. and Moderna Inc., both based on messenger RNA technology, and only offering Astra in cases where people can’t have an mRNA vaccine. AstraZeneca’s vaccine, one of the first to be developed, has grappled with safety concerns over potential side effects, including blood clotting. Though the U.S. has not cleared it for use, it’s been widely employed in Britain and many other countries, often to inoculate older adults.
14th Sep 2021 - Bloomberg

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Sep 2021

View this newsletter in full

Emergent to make Providence Therapeutics' potential COVID-19 vaccine

Emergent BioSolutions Inc signed a five-year agreement with Canadian biotechnology company Providence Therapeutics to develop and manufacture its COVID-19 vaccine candidate for about $90 million.
14th Sep 2021 - Reuters

CureVac slashes COVID-19 vaccine production plans

German biotech firm CureVac said on Tuesday it cancelled contract manufacturing deals for its experimental COVID-19 vaccine with two prospective partners, after rivals with approved shots have boosted production. Agreements with Celonic Group of Switzerland and Germany's Wacker would be terminated but existing production deals with Rentschler Biopharma and Novartis would remain unchanged, CureVac said in a statement. CureVac fell far behind rivals BioNTech, a partner of Pfizer, and Moderna, in trying to develop an mRNA-based COVID-19 vaccine.
14th Sep 2021 - Reuters on MSN.com

COVID-19: Deputy Chief Medical Officer says winter could be ‘bumpy at times’

Deputy Chief Medical Officer, Professor Jonathan Van-Tam says booster vaccines will be offered to people aged 50 and over, those in care homes, and frontline health and social care workers in order to manage what could be a ‘bumpy winter’ for the UK
14th Sep 2021 - Sky News

83% of stem cell recipients produce antibodies after 2 COVID-19 vaccine doses

Stem cell transplant recipients with cancers like leukemia had an antibody response rate of 83% to the second dose of the Pfizer/BioNTech mRNA COVID-19 vaccine, with almost two-thirds having very strong responses, an observational, single-center study today in JAMA Network Open finds. Researchers from Nantes University Hospital in France studied 117 coronavirus-naïve adults who received a donor stem cell transplant for the treatment of hematologic cancer and were given two doses of the Pfizer COVID-19 vaccine from Jan 20 to Apr 17. The median interval between the two doses was 22 days.
14th Sep 2021 - CIDRAP

A conversation with Bill Gates on how public health has fared in the midst of the pandemic

The foundation’s 2021 Goalkeepers report, published late Monday, shows an additional 10 million children around the globe didn’t get key childhood vaccines this past year, because of public health service disruptions. Another 31 million people were pushed into extreme poverty by the pandemic. And employment among women is expected to remain 13 million jobs lower around the world this year than it was in 2019.
14th Sep 2021 - CIDRAP

WHO-backed vaccine hub for Africa to copy Moderna COVID-19 shot

Efforts to develop an African base for COVID-19 vaccine production will focus on trying to replicate Moderna’s shot, but a lack of progress in talks with the US company mean the project will take time, a senior World Health Organization (WHO) official has said. The drive to produce vaccines in Africa is designed to help more developing countries access COVID-19 shots after rich nations bought up most of this year’s supply.
14th Sep 2021 - AlJazeera

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Sep 2021

View this newsletter in full

UK Canceling $1.7 Billion Vaccine Contract With Valneva Is a Bizarre Rug-Pull

The U.K. had poured millions of pounds into Valneva’s Scottish factory, secured an extra 40 million vaccine doses on top of the 60 million it had already agreed to buy, and boasted about the vaccine’s potential as a booster in the autumn. The fact that Valneva was headquartered in France, whose vaccine rollout was off to a dire start and where zero doses had been procured, was the ultimate punchline. Now the U.K. seems to have shot itself in the foot, rather than in the arm. The government is abruptly canceling its supply contract, having found Valneva in breach of its obligations without specifying how — something Valneva is contesting, though without giving more details.
13th Sep 2021 - Bloomberg

Covid-19: Single Pfizer jab recommended for 12 to 15-year-olds

The UK’s four Chief Medical Officers have recommended all children aged 12-15 should be vaccinated against Covid. They have agreed that children of those ages should be given one dose of the Pfizer vaccine to help prevent education being disrupted. A final decision on rollout will be taken by ministers in the four nations of the UK.
13th Sep 2021 - BBC News

UK scraps Covid-19 vaccine deal with French firm Valneva

French vaccine maker Valneva says the UK government has scrapped a deal for its Covid-19 vaccine. The UK had about 100 million doses on order, after it increased its request by 40 million in February. The firm said that the UK government served notice over allegations of a breach of the agreement, which it "strenuously denies". The government said the decision would have no impact on vaccine supply in the UK. "The comments from the company will not have any impact on our vaccine supply and did not form any part of our vaccine rollout in autumn and winter," a spokesperson for Prime Minister Boris Johnson said.
13th Sep 2021 - BBC News

Fully vaccinated people account for 1.2% of England’s Covid-19 deaths

People who were fully vaccinated accounted for just 1.2% of all deaths involving Covid-19 in England in the first seven months of this year. The figures, published by the Office for National Statistics (ONS), have been seized on as proof of the success of the vaccine programme. The figures show a total of 51,281 deaths involving Covid-19 in England between 2 January and 2 July, of which 38,964 were of unvaccinated people.
13th Sep 2021 - The Guardian

Departing FDA officials say it's too soon for COVID-19 boosters as White House plans rollout next week

Does the general U.S. population need COVID-19 boosters? A group of renowned global health experts, including two key departing vaccine authorities at the FDA, don't think so. Even with the wave of delta variant-driven coronavirus cases in the U.S., the authorized vaccines appear to be staving off severe infections, according to a paper published in The Lancet. The group of authors includes top officials with the World Health Organization. The paper stands in stark contrast to the Biden administration’s own booster shot plan, which some have criticized for jumping ahead of federal regulators. The White House has been planning to roll out the extra doses to the general population as early as next week following the FDA’s meeting on Friday to discuss Pfizer’s application for an extra shot.
13th Sep 2021 - FiercePharma

FDA vaccine regulators argue against Covid-19 vaccine boosters in new international review

A group of international experts — including, notably, two outgoing Food and Drug Administration vaccine regulators — argues in a new paper against offering Covid-19 vaccine boosters to the general population. The paper, published Monday in the Lancet, is based on a review of available data about the durability of vaccine protection. That it was co-authored by Marion Gruber and Phil Krause, two veteran FDA officials who have been leading the agency’s review of Covid-19 vaccine applications, amounts to a strikingly direct rebuff to the Biden administration as it lays plans for booster shots. Gruber and Krause announced last month they would be leaving the agency this fall.
13th Sep 2021 - STAT News

Most People Don’t Need Covid Vaccine Booster, Scientists Say

Governments would be better served to focus on immunizing the unvaccinated and to wait for more data on which boosters would be most effective and at what doses, the authors, who included two prominent U.S. Food and Drug Administration experts, argued in the medical journal The Lancet. They based their assessment on a wide range of real-world observational studies as well as data from clinical trials.
13th Sep 2021 - Bloomberg

Australia buys additional 1 mln doses of Moderna's COVID-19 vaccine

Australia has purchased an additional 1 million doses of Moderna's COVID-19 vaccine from the European Union, Prime Minister Scott Morrison said, as the country accelerates its inoculation programme to fight record high infections. The purchase is a boost for Australia's A$2 trillion ($1.5 trillion) economy, which is at risk of slipping into its second recession in as many years as a result of lockdowns of the country's two most populous cities, Sydney and Melbourne
12th Sep 2021 - Reuters

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Sep 2021

View this newsletter in full

Israel Is Preparing for Possible Fourth Covid Vaccine Dose

Israel is making preparations to ensure it has sufficient vaccine supply in case a fourth round of Covid-19 shots is needed, the country’s top health official said on Sunday. “We don’t know when it will happen; I hope very much that it won’t be within six months, like this time, and that the third dose will last for longer,” Health Ministry Director General Nachman Ash said in an interview with Radio 103FM. Israel, which has mainly used the Pfizer Inc.-BioNTech SE vaccine, has so far inoculated about 2.8 million people with a third dose after beginning a drive to administer booster shots in August. Health officials have said the effects of the initial Covid-19 shots weaken five months after inoculation, making boosters necessary.
12th Sep 2021 - Bloomberg

Oxford Covid jab faces effectively being withdrawn from Britain's vaccine rollout

Research suggests combining two different vaccines provides better protection Medical regulator ruled AstraZeneca cannot be used for third doses in this way Majority of third doses given out this autumn and winter are likely to be Pfizer
11th Sep 2021 - Daily Mail

Unvaccinated People 11 Times as Likely to Die From Covid-19

As the Delta variant became dominant in the U.S. this summer, data showed that unvaccinated Americans were 4.6 times as likely to be infected, 10 times as likely to be hospitalized and 11 times as likely to die from Covid-19 than vaccinated people. In a trio of studies released Friday underscoring the effectiveness of Covid-19 vaccines even against the highly contagious Delta variant, the Centers for Disease Control and Prevention examined Covid-19 outcomes among patients who visited emergency departments, urgent care centers and veterans’ hospitals. One study that tracked patients at five Veterans Affairs Medical Centers across the country between Feb. 1 and Aug. 6 found that mRNA vaccines were 87% effective at preventing Covid-19 associated hospitalization, including during the Delta surge. The study found that effectiveness dropped to 80% for patients over the age of 65, while for younger patients, the vaccines were 95% effective.
11th Sep 2021 - The Wall Street Journal

CDC study: Unvaccinated 11 times more likely to die from Covid-19

People who are not vaccinated against Covid-19 were 11 times more likely to die of the disease and 10 times more likely to be hospitalized with the disease, a study published on Friday by the US Centers for Disease Control and Prevention shows. The study looked at 600,000 Covid-19 cases in 13 states from April through mid-July. "The bottom line is this: We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of Covid-19," CDC Director Dr. Rochelle Walensky said Friday.
10th Sep 2021 - CNN

Brazil Moves Away from Chinese Covid-19 Vaccine

Brazil, a major buyer of China’s CoronaVac shot and a poster child for Beijing’s efforts at vaccine diplomacy, is making a speedy retreat from the Covid-19 vaccine as concerns grow over its efficacy against the Delta variant and other vaccines become more readily available. Brazil’s federal government has halted negotiations over additional doses of Sinovac’s vaccine, CoronaVac, spokespeople for the government and its local producer, the Butantan Institute, told The Wall Street Journal. The government has also said it won’t recommend use of CoronaVac for a third booster shot.
11th Sep 2021 - The Wall Street Journal

FDA Again Warns Parents Not to Get Children Under 12 Vaccinated Yet

The U.S. Food and Drug Administration is “working around the clock” to make Covid vaccines available to young children, it said in a statement on Friday. In the meantime, however, the agency urged parents not to seek out the shots for children who are under 12, and therefore not yet eligible for vaccination. The agency said that it hoped vaccines would be available for young children “in the coming months,” but that it could not offer a more specific timeline. However, once it has applications from the vaccine manufacturers in hand, it will “be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” Dr. Janet Woodcock, the acting F.D.A. commissioner, and Dr. Peter Marks, of the agency’s Center for Biologics Research and Evaluation, said in the statement.
11th Sep 2021 - The New York Times

Vietnam approves Hayat-Vax coronavirus vaccine for emergency use

Vietnam has approved the Hayat-Vax coronavirus vaccine for emergency use, the seventh to be endorsed in the country.
11th Sep 2021 - Reuters

S.Africa's regulator approves Pfizer COVID-19 shot for children 12 and up

South Africa's health regulator has approved Pfizer's COVID-19 vaccine for use by children aged 12 and older, paving the way for the government to offer vaccinations to teenagers. The South African Health Products Authority (SAPHRA) said the decision came after a review of updated safety and efficacy information submitted in March this year. After a bumpy start, South Africa's vaccination campaign has ramped up in recent months with a solid supply of shots secured and just over 12% of its more than 60 million people vaccinated. That puts the country well ahead of others on the continent.
11th Sep 2021 - Reuters

South Africa vaccinates children in test of China’s Sinovac jab

The global study is to enroll 2,000 participants in South Africa while 12,000 others will be taking part in Kenya, the Philippines, Chile and Malaysia.
11th Sep 2021 - Al Jazeera English

Some Vaccines Last a Lifetime. Here’s Why Covid-19 Shots Don’t.

Why don’t Covid-19 vaccinations last longer? Measles shots are good for life, chickenpox immunizations protect for 10 to 20 years, and tetanus jabs last a decade or more. But U.S. officials are weighing whether to authorize Covid-19 boosters for vaccinated adults as soon as six months after the initial inoculation. The goal of a vaccine is to provide the protection afforded by natural infection, but without the risk of serious illness or death. “A really good vaccine makes it so someone does not get infected even if they are exposed to the virus,” said Rustom Antia, a biology professor at Emory University who studies immune responses. “But not all vaccines are ideal.”
11th Sep 2021 - The Wall Street Journal

Covid-19: Hospital may cease giving patient ivermectin, US court rules, as prescriptions soar

An Ohio judge has overturned an earlier court order that forced a hospital to treat a covid-19 patient with the antiparasitic drug ivermectin, popularised by US conservative media. West Chester Hospital was ordered to administer the unproved drug by a county judge on 23 August, after Julie Smith sued on behalf of her husband, Jeffrey Smith, who has been in intensive care since 15 July and on a ventilator since 1 August. Julie Smith launched her lawsuit after the hospital declined to fill a prescription she had obtained from Fred Wagshul, one of three doctors who last year founded the Front Line COVID-19 Critical Care Alliance (FLCCCA), a group that has spread claims of ivermectin’s efficacy against the coronavirus.
11th Sep 2021 - The BMJ

More US studies show COVID vaccines protect from serious illness

The United States Centers for Disease Control and Prevention (CDC) has presented data showing unvaccinated people are four-and-a-half times more likely to contract COVID-19 and 11 times more likely to die from it than those fully vaccinated. In a White House COVID-19 briefing on Friday, CDC Director Dr Rochelle Walensky said the data shows “vaccination works and will protect us from the severe complications of COVID-19”.
11th Sep 2021 - Al Jazeera English

Pfizer to seek approval for vaccine in children 5 and over

Pfizer and BioNTech announced this week that it will soon seek approval from global regulators for use of its coronavirus vaccine in children ages 5 and over. The vaccine makers said in an interview published on Friday that they are looking to produce smaller doses of the vaccine for younger children. “We will be presenting the results from our study on five- to 11-year-olds to authorities around the world in the coming weeks,” Ozlem Tureci, the co-founder of BioNTech and its chief medical officer, told German news outlet Der Spiegel.
11th Sep 2021 - The Hill

Unvaccinated Americans Are 11 Times More Likely to Die of Covid, C.D.C. Reports

Three studies that drew data from different U.S. regions evaluated the protective power of the vaccines. One looked at more than 600,000 virus cases in 13 states, representing about one quarter of the U.S. population, between April and July, and concluded that individuals who were not fully vaccinated were far more susceptible to infection and death from the virus. They were 4.5 times more likely than vaccinated individuals to become infected, 10 times more likely to be hospitalized, and 11 times more likely to die from the coronavirus, the study found.
10th Sep 2021 - The New York Times

Scientists' egos are key barrier to progress, says Covid vaccine pioneer

Scientists would make swifter progress in solving the world’s problems if they learned to put their egos aside and collaborate better, according to the leading researcher behind the Pfizer/BioNTech Covid vaccine. Prof Katalin Karikó, the senior vice-president for RNA protein replacement therapies at BioNTech in Germany, endured decades of scepticism over her work and was demoted and finally kicked out of her lab while developing the technology that made the Pfizer and Moderna vaccines possible.
10th Sep 2021 - The Guardian

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Sep 2021

View this newsletter in full

Massive numbers of new COVID–19 infections, not vaccines, are the main driver of new coronavirus variants

It’s natural to wonder if highly effective COVID-19 vaccines are leading to the emergence of variants that evade the vaccine – like dark peppered moths evaded birds that hunted them. But with just under 40% of people in the world having received a dose of a vaccine – only 2% in low-income countries – and nearly a million new infections occurring globally every day, the emergence of new, more contagious variants, like delta, is being driven by uncontrolled transmission, not vaccines.
9th Sep 2021 - The Conversation

Novavax developing joint COVID/flu vaccine

Vaccine manufacturer Novavax has announced it is developing a joint COVID-19/flu shot that is currently in the trial stage. Novavax already manufactures flu shots and a COVID-19 vaccine, which has not yet been approved for public use in Australia. However, the government has placed an order for 51 million doses.
9th Sep 2021 - 9News

Co-inventor of mRNA shots sets sights on pan-coronavirus vaccine

Drew Weissman's decades of research helped pave the way for mRNA Covid-19 vaccines, but the scientist isn't resting on his laurels. The University of Pennsylvania immunologist, who on Thursday shared the $3 million 2022 Breakthrough Prize in Life Sciences with his longtime collaborator Katalin Kariko, is now spearheading efforts to design a new vaccine against all coronaviruses. The Silicon Valley-backed award honors major discoveries with the highest cash amounts in science.
9th Sep 2021 - FRANCE 24

Risk of severe breakthrough Covid-19 higher for seniors and people with underlying conditions

For fully vaccinated Americans, the risk of being hospitalized or dying from Covid-19 is low -- much lower than the risk for unvaccinated people. But in those rare cases when a fully vaccinated person gets infected, data suggests it's older adults and those with multiple underlying medical conditions who are most at risk of serious illness. As of August 30, the US Centers for Disease Control and Prevention has received reports of 12,908 severe breakthrough cases of Covid-19 among fully vaccinated people that resulted in hospitalization or death. For the more than 173 million people who were fully vaccinated by that date, that represents a less than a 1 in 13,000 chance of experiencing a severe breakthrough case of Covid-19.
9th Sep 2021 - CNN

U.S. FDA declines emergency use approval for Humanigen's COVID-19 drug

The U.S. Food and Drug Administration declined Humanigen Inc's request for emergency use authorization (EUA) of its lenzilumab drug to treat newly hospitalized COVID-19 patients, the company said on Thursday. "In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19," the company said in a statement.
9th Sep 2021 - Reuters

Trial of Covid-19 vaccine and flu jab combined to begin in Australia on 640 healthy residents

Vaccine developer Novavax will trial a combined flu and Covid-19 vaccination. The tests in Australia will include 640 healthy adults aged between 50-70. Who have previously been infected or received a Covid jab at least 8 weeks prior. Novavax said that flu and Covid combination vaccines will combat new variants
9th Sep 2021 - Daily Mail

Moderna developing single-dose booster shot for COVID-19 and flu

Moderna Inc said on Thursday it is developing a single vaccine that combines a booster dose against COVID-19 with its experimental flu shot. The company hopes to eventually add vaccines it is working on for respiratory syncytial virus (RSV) and other respiratory diseases as an annual shot. "We believe this is a very large opportunity that is ahead of us, if we could bring to market a high efficacy pan-respiratory annual booster," Moderna Chief Executive Officer Stéphane Bancel said during a presentation to update investors on its drugs in development.
9th Sep 2021 - Reuters

Covid-19: More than 60 frontline UK healthcare workers took their own life at the beginning of the pandemic

The Laura Hyde Foundation is calling for 999 workers to sound their sirens at 9am on 9 September in remembrance of their colleagues. More than 60 frontline healthcare workers died of suicide at the beginning of the Covid-19 pandemic, i can reveal. Among the 64 deaths in the first six months of 2020, which included nurses, midwives and paramedics, more than a quarter were newly-qualified workers. The Laura Hyde Foundation (LHF) – a mental health charity for the emergency services – which requested the statistics from the Office for National Statistics (ONS), said the figures were “deeply disturbing”.
9th Sep 2021 - iNews

Risk of contracting Covid-19 on flights is 0.1%, claims new research

The risk of exposure to Covid-19 on a flight where every passenger has tested negative is less than 0.1 per cent, according to new research. The new peer-reviewed study used data from nearly 10,000 air travellers on Delta’s Covid-tested flight corridors between New York’s JFK, Atlanta and Italy’s Fiumicino airports to conclude that a single molecular test performed within 72 hours of departure could significantly decrease the rate of people infected onboard a commercial aircraft. The research, conducted by the Georgia Department of Health and Mayo Clinic in conjunction with Delta airlines, states that infection rates on Covid-19 tested flights constituted 0.5 per cent, or five in 10,000 passengers, compared with 1.1 percent, or one in 100 people, in the community.
9th Sep 2021 - The Independent

Can kids get ‘long COVID’ after coronavirus infections?

Can kids get “long COVID” after coronavirus infections? Yes, but studies indicate they’re less likely than adults to be affected by symptoms that persist, recur or begin a month or more after infection. Estimates vary on how often the symptoms known as long COVID-19 occur in kids. A recently published U.K. study found about 4% of young children and teens had symptoms more than a month after getting infected. Fatigue, headaches and loss of smell were among the most common complaints and most were gone by two months. Coughing, chest pain and brain fog are among other long-term symptoms sometimes found in kids, and can occur even after mild infections or no initial symptoms.
9th Sep 2021 - The Conversation

AstraZeneca's COVID-19 shot joins the list of vaccines flagged for rare Guillain-Barre syndrome

Two months after the FDA flagged Johnson & Johnson’s COVID-19 vaccine for the rare nerve disorder Guillain-Barre syndrome (GBS) Europe’s drug regulator has done the same for AstraZeneca’s COVID shot. The European Medicines Agency will now list GBS as a possible and “very rare” side effect of Vaxzevria, which is administered as a two-dose regimen. Of the 592 million doses of the vaccine administered worldwide through the end of July, 833 cases of the nerve-damaging condition were reported. Both are adenovirus-based vaccines, as opposed to the mRNA shots offered by Moderna and Pfizer/BioNTech. The J&J and AZ vaccines also have been linked to very rare cases of blood clots that occur alongside bleeding.
9th Sep 2021 - FiercePharma

How the Delta variant’s remarkable ability to replicate threw new twists into the Covid-19 pandemic

One of the key reasons the Delta variant has ignited new surges of Covid-19 infections across the United States is its remarkable ability to make copies of itself. That skill has helped make Delta far more transmissible than any other iteration of the coronavirus seen thus far. But its replication prowess could also be at the heart of the other twists Delta has thrown into the pandemic, including the increase in breakthrough infections with the variant and why it potentially causes severe Covid-19 more often. Delta’s breakneck proliferation isn’t its only trick tied to the increase in infections — and symptomatic infections — in people who’ve been vaccinated.
9th Sep 2021 - STAT News

Study says Alpha variant doubled COVID cases in Israeli kids

The SARS-CoV-2 Alpha (B117) variant spread faster and more efficiently than previous strains among children 9 years and younger in Israel in late 2020 and early 2021, even amid the concurrent immunization of adults against COVID-19, according to an observational study yesterday in JAMA Network Open. A team led by a researcher at Schneider Children's Medical Center of Israel in Petah Tikva compared the publicly available daily data of 21,615 children who tested positive for COVID-19 from Aug 1 to Oct 2, 2020, with those of 50,811 children who tested positive from Dec 3, 2020, to Feb 3, 2021. The researchers adjusted weekly incidence rates according to the number of COVID-19 tests performed.
8th Sep 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Sep 2021

View this newsletter in full

W.H.O. Warns of Dire Threat of Covid During Pregnancy in Latin America

The coronavirus pandemic could “wipe away 20 years of hard-fought gains” in reducing maternal mortality in Latin America and the Caribbean, and countries in the region should prioritize those who are pregnant and those who have recently given birth in their vaccination campaigns, officials at the World Health Organization warned on Wednesday. “So far, more than 270,000 pregnant women have become sick with Covid in the Americas and more than 2,600 of them — or 1 percent of those infected — have died from the virus,” Dr. Carissa F. Etienne, the director of the Pan American Health Organization, a division of the W.H.O., said at a news conference.
9th Sep 2021 - The New York Times

Novavax begins early-stage trial for flu-Covid combo vaccine

Vaccine developer Novavax Inc said today it has initiated an early-stage study to test its combined flu and Covid-19 vaccine. The trial, to be conducted in Australia, will enrol 640 healthy adults between the ages of 50 and 70 years and who have either been previously infected with the coronavirus or given an authorized Covid-19 vaccine at least eight weeks prior to the study.
8th Sep 2021 - Free Malaysia Today

Countries should prioritize pregnant, breastfeeding women for COVID-19 shots -PAHO

Countries in the Americas should prioritize pregnant and lactating women in distribution of COVID-19 shots, the Pan American Health Organization (PAHO) said on Wednesday, hailing the ability of the vaccines to protect women and their babies. "PAHO recommends that all pregnant women after their first trimester, as well as those who are breastfeeding, receive the COVID-19 vaccine," PAHO Director Dr. Carissa Etienne said during the organization's weekly virtual briefing.
8th Sep 2021 - Reuters

EU lists rare nerve disorder as possible side-effect of AstraZeneca COVID-19 vaccine

Europe's medicines regulator has added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome, as a possible side-effect of AstraZeneca's COVID-19 vaccine, regular safety updates from the watchdog showed on Wednesday. The European Medicines Agency said a causal relationship between GBS and the AstraZeneca shot, known as Vaxzevria, was a "at least a reasonable possibility" after 833 cases of GBS were reported out of 592 million doses of the vaccine given worldwide by July 31.
8th Sep 2021 - Reuters

Ireland to give COVID-19 vaccine booster shot to over-80s

Ireland will give COVID-19 vaccine booster shots to elderly people who were fully vaccinated at least six months ago, the health ministry said on Wednesday. People over the age of 80 and those over 65 living in long-term residential care facilities will receive a booster dose of a vaccine such as those made by Pfizer or Moderna, irrespective of what vaccine they received initially, the ministry said in a statement.
8th Sep 2021 - Reuters

Covid booster vaccines to be approved in 'next few days' as work is 'almost done'

A Covid booster vaccine rollout is set to be recommended by the government's advisors in the 'next few days' as the work is 'almost done', the Health Secretary has declared. Sajid Javid said he expected the Joint Committee on Vaccination and Immunisation to imminently spell out exactly who should get a third dose of the vaccine, how, and in what order. JCVI experts have spent months studying how boosters should be rolled out - including whether different vaccine brands can be 'mixed and matched', and whether the flu jab should be given at the same time.
8th Sep 2021 - The Mirror

Vietnam to mix Moderna and Pfizer-BioNTech COVID-19 vaccines - media

Vietnam's health ministry will offer the coronavirus vaccine jointly developed by Pfizer and BioNTech as a second dose option for people first inoculated with the Moderna vaccine, state media reported on Wednesday. The ministry had approved the mixed regimen, which is due to low supplies of the Moderna vaccine. Both vaccines are of the Messenger RNA (mRNA) type.
8th Sep 2021 - Reuters

Takeda to deliver Novavax’s Covid-19 vaccine doses to Japan

Takeda plans to supply the vaccine doses earlier next year on obtaining approval from the country’s MHLW. The Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) has agreed to procure 150 million doses of Novavax’s Covid-19 vaccine candidate produced by Takeda Pharmaceutical in the country on obtaining approval.
8th Sep 2021 - Pharmaceutical Technology

Schools don't need to see a big uptick in Covid-19 cases if they follow these measures, Fauci says

Surging Covid-19 cases -- and the increasing proportion reported in children -- are causing many health experts to worry about the outlook as the school year gets underway across the entire country. But Dr. Anthony Fauci said there shouldn't be a big uptick "if we do it right." "We've gotta get the school system masked in addition to surrounding the children with vaccinated people," said the director of the National Institute of Allergy and Infectious Diseases. "That's the solution."
8th Sep 2021 - CNN

Novavax begins early-stage trial for combined influenza/COVID-19 vaccine

Vaccine developer Novavax Inc said on Wednesday it has initiated an early-stage study to test its combined flu and COVID-19 vaccine. The trial, to be conducted in Australia, will enroll 640 healthy adults between the ages of 50 and 70 years and who have either been previously infected with the coronavirus or given an authorized COVID-19 vaccine at least eight weeks prior to the study.
8th Sep 2021 - Reuters

UK's Exscientia, Gates Foundation partner to develop variant-resistant COVID-19 drugs

The Bill & Melinda Gates Foundation would make a $35 million equity investment in privately owned Exscientia Ltd to fund the development of antiviral drugs including for the coronavirus, the Oxford-based drug developer said on Wednesday. Exscientia will make a matching contribution and lead the development of up to five therapeutics, which are ready to enter human trials. The program will initially focus on agents against the SARS-CoV-2 and its variants as well as other coronaviruses.
8th Sep 2021 - Reuters

Moderna taps National Resilience's new Canadian manufacturing site for COVID-19 vaccine production duties

Fresh off National Resilience's acquisition of a new, state-of-the-art manufacturing site in Ontario, the fledgling CDMO is putting it to the test with a high-profile partnership. Moderna has tapped National Resilience, founded in November last year, to manufacture mRNA vaccine substance at Resilience’s newly acquired facility in Mississauga, Canada. While sparse on details, Moderna said the substance made at the plant will be delivered globally. The partnership marks Moderna’s most recent foray into Canada and comes as the biotech faces a vaccine contamination scandal in Japan. In late August, Japanese pharma Takeda, which distributes Moderna’s shot in the country, said it suspended three lots—or about 1.63 million doses—after finding tiny black specks in the vials.
8th Sep 2021 - FiercePharma

Moderna turns to biotech startup to ramp up Covid vaccine manufacturing

Moderna will turn to a biotech startup, National Resilience, to manufacture additional doses of its Covid-19 vaccine. Moderna had previously said it would manufacture 800 million to 1 billion doses of its Covid-19 vaccine in 2021, ramping up to 3 billion doses in 2022. A person familiar with the company said the collaboration might result in hundreds of millions more doses. Currently, the vaccine is given as a two-dose series, though Moderna has said at least some patients may need a third dose given many months later. National Resilience will manufacture mRNA to produce the Moderna Covid-19 vaccine at its facility in Mississauga, Ontario, for worldwide distribution. The company is headquartered in San Diego and Cambridge, Mass.
8th Sep 2021 - STAT News

Efforts grow to stamp out use of parasite drug for COVID-19

Health experts and medical groups are pushing to stamp out the growing use of a decades-old parasite drug to treat COVID-19, warning that it can cause harmful side effects and that there’s little evidence it helps. With a fourth wave of infections, more Americans are turning to ivermectin, a cheap drug used to kill worms and other parasites in humans and animals.
7th Sep 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Sep 2021

View this newsletter in full

Covid in Scotland: 'I'm double-vaccinated but can't show the proof'

A woman who was vaccinated in England and Scotland says she cannot get an accurate vaccination certificate because of issues with data-sharing across health services. Maura McGoldrick, 21, received her first dose in London and her second in Glasgow, where she lives. However, her vaccination record only shows her having received one dose. The fourth-year student at the University of Edinburgh is concerned others may be similarly affected.
7th Sep 2021 - BBC News

Vaccine makers should supply shots for trials to help spur sector -CEPI

New vaccine trials need established shots for control group-CEPI. Warns against development "standstill" amid lack of vaccines. Companies, countries need to spare 10s of thousands of doses
7th Sep 2021 - Reuters

Third person dies in Japan after taking contaminated Moderna coronavirus vaccine

A third man has died in Japan after receiving an injection from one of three batches of Moderna vaccines since identified as contaminated, though authorities say no causal link has yet been found. The 49-year-old man had his second shot on 11 August and died the following day. His only known health issue was an allergy to buckwheat, the health ministry said on Monday. As with the previous two deaths, the ministry said it had yet to establish if the latest fatality was linked to the vaccine.
7th Sep 2021 - The Guardian

EMA begins analysis of Pfizer-BioNTech’s Covid-19 booster shot data

The European Medicines Agency (EMA) has commenced evaluation of an application submitted by Pfizer and BioNTech seeking an update to conditional marketing authorization (CMA) for the use of a booster shot of their Covid-19 vaccine, Comirnaty. A messenger ribonucleic acid (mRNA) vaccine, Comirnaty was granted a CMA by the European Commission in December last year. The third or booster shot is intended to be administered six months after the second dose in individuals aged 16 years or above, Pfizer noted.
7th Sep 2021 - Pharmaceutical Technology

Japan picks three COVID-19 drug candidates to get research funds

Japan has selected three candidates for COVID-19 treatments to receive subsidies for clinical trials, the health ministry said on Tuesday. The drugs are AstraZeneca Plc's antibody treatment AZD7442, Shionogi & Co's protease inhibitor S-217622, and Fujifilm Holding Corp's antiviral favipiravir, known commercially as Avigan.
7th Sep 2021 - Reuters

Indonesia approves J&J, Cansino COVID-19 vaccines for emergency use

Indonesia has approved the single-dose COVID-19 vaccines produced by Janssen Pharmaceutical Companies, part of Johnson & Johnson, and China's CanSino Biological Inc for emergency use, the country's food and drug agency said in a statement on Tuesday.
7th Sep 2021 - Reuters

New Studies Find Evidence Of 'Superhuman' Immunity To COVID-19 In Some Individuals

Some scientists have called it "superhuman immunity" or "bulletproof." But immunologist Shane Crotty prefers "hybrid immunity." "Overall, hybrid immunity to SARS-CoV-2 appears to be impressively potent," Crotty wrote in commentary in Science back in June. No matter what you call it, this type of immunity offers much-needed good news in what seems like an endless array of bad news regarding COVID-19. Over the past several months, a series of studies has found that some people mount an extraordinarily powerful immune response against SARS-CoV-2, the coronavirus that causes the disease COVID-19.
7th Sep 2021 - NPR

COVID-19: release approved vaccines for trials of new ones

Scientists must develop the next generation of COVID-19 vaccines now, if the world is to meet the challenge of SARS-CoV-2 variants and reduce vaccine inequity by increasing global supply. This can be done only if comparator COVID-19 vaccines — those that have already been approved — are available to support clinical trials. Such comparator vaccines are almost impossible to secure; governments, developers and manufacturers must find a solution to unlock supplies. So far, COVID-19 vaccines have received approval on the basis of data from unvaccinated participants in placebo-controlled efficacy trials. These trials become increasingly difficult to carry out as the number of people who are immunized rises. Comparator vaccines, essentially replacing placebos, are therefore needed for trials that assess whether new candidate vaccines provide comparable levels of protection, including against emerging variants.
7th Sep 2021 - Nature.com

How the risk of side effects could change with Covid-19 vaccine boosters

Additional doses of Covid-19 vaccines are likely rolling out in the United States later this year. It raises the question: What will the side effects from a booster shot look like? Is there a higher or lower risk of an adverse event, compared to the earlier regimens? Overall, the Covid-19 vaccines are overwhelmingly safe and remarkably effective. But as the shots went into millions of arms starting late last year, researchers uncovered a handful of sometimes serious side effects, which were so exceedingly rare that the clinical trials that led to the shots’ authorizations — even with tens of thousands of participants — couldn’t capture them.
7th Sep 2021 - STAT News

What we know about the new C.1.2 coronavirus variant

While much of the world’s focus has been on the Delta variant of coronavirus, a new variant has been identified in South Africa. Currently referred to as the C.1.2 variant, it is yet to be called a variant of interest or concern by the World Health Organization (WHO), but is drawing the attention of scientists due to the number and types of mutations it contains and the speed at which the mutations have occurred.
7th Sep 2021 - AlJazeera

After Moderna contamination mess, Takeda strikes deal with Japan to supply Novavax COVID-19 vaccines

As Moderna faces questions about contaminants found in its COVID-19 vaccines in Japan, the company’s distribution partner in the country, Takeda, is moving forward on its plans with another COVID vaccine developer. On Monday, Takeda said the Japanese government has agreed to purchase 150 million doses of the Novavax shot that it will produce. Takeda and Novavax previously struck a licensing and production deal covering the country. The Novavax shot remains in development, and the partners aim to start the rollout in Japan early next year. The government's purchasing agreement is subject to regulatory approvals.
7th Sep 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Sep 2021

View this newsletter in full

Why a Covid-19 Vaccine for Children Is Taking So Long

Researchers testing shots in children face serious challenges, starting with making the lower dose under study
6th Sep 2021 - The Wall Street Journal

South African Scientists Say New Covid Variant Slows Its Spread

South African scientists said a new variant, with a concerning number of mutations, spread at a slower rate last month than in July. The so-called C.1.2 variant accounted for just 1.5% of all virus samples sequenced in the country in August compared with 2.2% in July, according to the Network for Genomic Surveillance South Africa. The variant, first identified in South Africa, has been found in a number of countries including the Democratic Republic of Congo, Mauritius, Portugal, New Zealand and Switzerland.
6th Sep 2021 - Bloomberg

Chilean health regulator approves CoronaVac use among children over age 6

The Chilean health regulator on Monday approved the COVID-19 vaccine produced by China's Sinovac Biotech Ltd for use in children over 6 years of age, allowing more people to be included in the country's rapid inoculation campaign.
6th Sep 2021 - Reuters

Sinovac booster shot reverses drop in antibody activities against Delta-study

A booster dose of Sinovac Biotech's COVID-19 vaccine reversed a decline in antibody activities against the Delta variant, a study showed, easing some concerns about its longer-term immune response to the highly contagious strain of the virus. The study comes amid concerns about the Chinese vaccine's efficacy against Delta, which has become the dominant variant globally and is driving a surge in new infections even in the most vaccinated countries.
6th Sep 2021 - Reuters

Brazil suspends use of millions of doses of China's Sinovac coronavirus vaccine

Brazil’s health regulator suspended the use of just over 12.1 million doses of the coronavirus vaccine manufactured by China’s Sinovac after learning that vials containing the shots were filled at an unauthorized production base. The suspension is for 90 days as an investigation is carried out, said Anvisa, the regulator, which announced the decision in a statement Saturday. The Butantan Institute, a Sao Paulo biomedical center that has partnered with Sinovac to fill the vaccine for local usage, notified Anvisa about the irregularity the prior day, the agency said.
6th Sep 2021 - The Washington Post

Denmark cancels tender for domestic coronavirus vaccine production

Denmark has cancelled its previously announced plans for a public tender to establish a national COVID-19 vaccine production facility as it bets on a vaccine already under development by a Danish firm, the Business Ministry said on Monday. Prime Minister Mette Frederiksen announced in April that Denmark aimed to produce COVID-19 mRNA-vaccines by 2022, and that a tendering process would be initiated within a few weeks.
6th Sep 2021 - Reuters

China’s Sinopharm seeks to develop its own mRNA Covid vaccine

Sinopharm is developing a homegrown messenger RNA inoculation for Covid-19, becoming one of the first big Chinese pharmaceutical groups to pursue the technology to combat the disease. The state-owned pharma group’s move comes as concerns grow over the efficacy of conventional inactivated virus vaccines, which have dominated the rollout in China. Certain studies have shown the jabs produce fewer antibodies compared with mRNA shots. Inactivated vaccines, such as Sinopharm’s existing Covid vaccine, use dead viral particles to produce an immune response, while mRNA jabs contain genetic instructions that tell cells to make viral proteins that prime the immune system.
6th Sep 2021 - Financial Times

NHS ‘ready to go’ with Covid jab booster programme, says vaccines minister

The NHS’s vaccine booster programme is “ready to go” and only waiting for scientists to sign off on plans for third jabs, the vaccines minister has said. Speaking in the House of Commons, Nadhim Zahawi, said getting booster vaccines into people’s arms would be a major part of ending the pandemic for good.
6th Sep 2021 - The Independent

Spread of Delta variant driven by immune escape and greater infectivity – study

The coronavirus Delta variant, which has become dominant in a number of countries including the UK, most likely spreads through its ability to evade antibodies and its increased infectivity, researchers have said. As the virus replicates, errors in its genetic make-up cause it to mutate. Some mutations make it more transmissible or more infectious, some help it evade the immune response, potentially making vaccines less effective, while others have little effect.
6th Sep 2021 - Evening Standard

EU watchdog studying data on Pfizer COVID-19 vaccine booster dose

Europe's medicines regulator said on Monday it was evaluating data on a booster dose for Pfizer/BioNTech's COVID-19 vaccine, to be given six months after the second dose in people 16 years of age and older.
6th Sep 2021 - Reuters

Sinovac booster shot reverses drop in antibody activities against Delta-study

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Sep 2021

View this newsletter in full

Israel to present COVID-19 booster shot data to FDA experts

Israel this month will present data from an extensive rollout of COVID-19 vaccine booster shots to the U.S. Food and Drug Administration, which is weighing White House plans to begin a booster drive in the United States. Sharon Alroy-Preis, head of public health at Israel's Health Ministry, said the ministry had been asked by the U.S. Food and Drug Administration (FDA) to brief its advisors at a Sept. 17 meeting.
5th Sep 2021 - Reuters

What Vaccinated People Need to Know About Breakthrough Infections

If you’re vaccinated, you should think about a number of variables, including your overall health, where you live and the risks you take.
5th Sep 2021 - The New York Times

FDA Pushes for Moderna Booster Shot Data in Weighing Dose

U.S. health regulators are seeking additional coronavirus booster shot data from Moderna Inc., as the Biden administration expects to begin a widespread booster campaign this month with only the Pfizer Inc.-BioNTech vaccine, people familiar with the matter say. Moderna announced Friday that it had “completed” its submission of data to the Food and Drug Administration for authorization of boosters. The FDA has been seeking more data as Moderna’s submission rolled in, the people added.
4th Sep 2021 - Bloomberg

‘Far too early’ for South African C.1.2 virus variant to cause concern

It is too early to say if the new variant of COVID-19 spotted in South Africa will become a major player in the pandemic – or fizzle out like many variants spotted before. Known as C.1.2, the variant has attracted panicked headlines around Australia and the world due to its collection of mutations, some of which it shares with other variants of concern.
4th Sep 2021 - Sydney Morning Herald

Everything we know about the mu variant, the latest coronavirus mutation

On Monday the World Health Organization (WHO) officially labeled the mu variant as a "variant of interest," a designation that indicates a need for further study about possible dangers while falling short of the more serious classification, "variant of concern." Variants of concern are regarded as a top priority because they are more immunity-resistant, contagious or deadly than other strains. Currently the WHO considers four strains to meet those criteria: alpha, beta, gamma and delta (the variant most prevalent in the United States).
4th Sep 2021 - Salon

AstraZeneca reaches settlement with EU on COVID-19 vaccine delivery

Settlement brings doses delivered to 300 million as agreed. Agreement will also end pending litigation in Brussels. Capped rebates on vaccine will apply if doses are delayed. Doses will go to EU-laggards in uptake ranking, COVAX facility
3rd Sep 2021 - Reuters

EU reviewing risk of rare inflammation after COVID-19 vaccinations

Europe's medicines regulator said on Friday it was reviewing if COVID-19 vaccines caused a risk of a rare inflammatory condition, following a report of a case with Pfizer/BioNTech's shot. The safety panel of the European Medicines Agency is looking into Multisystem Inflammatory Syndrome (MIS) after the condition was reported in a 17-year-old male in Denmark, the agency said.
3rd Sep 2021 - Reuters

Australia approves highly effective Moderna Covid-19 jab for children aged 12 to 17

Australia's medical regulator approves American Moderna jab for all over 12s Medical regulator boss said the jab was 98% effective against severe disease One million doses will arrive in September and 10million by the end of the year In 2022 Australia will receive 15 million of Moderna's 'updated' variant boosters The move helps nation reach 70 per cent vaccination rate to end lockdowns
3rd Sep 2021 - Daily Mail

U.S. COVID-19 booster shot campaign to start with only Pfizer - source

A White House plan to offer COVID-19 booster shots will most likely start this month only with the vaccine made by Pfizer Inc and BioNTech, a narrower initiative than anticipated, a source familiar with the matter said on Friday. President Joe Biden had expected to launch a campaign to administer 100 million booster shots on Sept. 20. But U.S. vaccine makers other than Pfizer have lagged in seeking authorization of an additional dose.
3rd Sep 2021 - Reuters

Moderna seeks EU authorization for COVID-19 vaccine booster dose

Moderna Inc said on Friday it had asked the EU drugs regulator for conditional approval of a booster shot of its COVID-19 vaccine at a 50 microgram dose.
3rd Sep 2021 - Reuters

Analysis: Are COVID boosters needed? FDA vaccine advisers wrestle with a thorny issue

The debate will likely be heated following the Biden Administration's announcement last month - before the experts could weigh in - that the U.S. plans to start booster doses Sept. 20 if regulators approve them. The White House move usurped the normal process in which the FDA and the U.S. Centers for Disease Control and Prevention make these sort of science-based decisions, according to interviews with six current and former FDA scientists and CDC advisory panel members.
3rd Sep 2021 - Reuters on MSN.com

A new COVID-19 variant called Mu that might be able to evade immunity from vaccines has been detected in almost every US state

A new COVID-19 variant called Mu might be able to evade the immunity people get from vaccines, Insider reported. The Mu variant has been detected in 47 US states and the District of Columbia, according to data from Outbreak.info. Only Nebraska, Vermont, and South Dakota are yet to detect a case, the data says.
3rd Sep 2021 - Business Insider on MSN.com

Fauci says he's 'keeping a very close eye on' new COVID-19 variant

The variant, labelled “mu,” has been detected in 39 countries in South America and Europe. “We certainly are aware of the mu variant. We’re keeping a very close eye on it,” Anthony Fauci said. “We don’t consider it an immediate threat right now,” he added.
3rd Sep 2021 - The Hill

One Vaccine Makes More Antibodies Than Another. Does it Matter?

Ten months ago, the results of large clinical trials appeared almost too good to be true: Two messenger RNA vaccines reduced symptomatic Covid-19 cases by more than 90% in almost every group that got them. Now, subtle differences between the Pfizer Inc.-BioNTech SE and Moderna Inc. vaccines are emerging across patient groups over time. One small U.S. study found waning levels of antibodies with Pfizer’s vaccine, particularly in an older group of people. And a larger study from Belgium found that Moderna’s shot may generate more antibodies than Pfizer’s.
3rd Sep 2021 - Bloomberg

No Mu variant detected in Philippines so far — genome center

The Philippines has not yet detected the presence of the new coronavirus variant known as “Mu,” the country’s genome center said on Friday. “We went back to our database, we have sequenced more than 12,000 [samples]…We have not yet detected Mu variant in the Philippines,” Philippine Genome Center Executive Director Cynthia Saloma said in a briefing.
3rd Sep 2021 - Philstar.com

Moderna vaccine approved for children 12 years and older, in line with Pfizer vaccine

Moderna's COVID-19 vaccine has been approved by Australian health authorities for children as young as 12. The vaccine was already approved for adults 18 and over, and the Therapeutic Goods Administration has now extended that approval down to teenagers. It brings the vaccine into line with the extremely similar Pfizer vaccine. Both are based on MRNA technology.
3rd Sep 2021 - ABC News

mRNA COVID vaccines not tied to serious side effects

Lilly's COVID-19 antibody combo cleared for nationwide use as feds say it can tackle the dominant delta variant

That didn't take long. Only a few days after Eli Lilly's COVID-19 antibody combo of bamlanivimab and etesevimab made its return to more than 20 states, federal officials are resuming distribution nationwide. In a Thursday alert, officials said Lilly's drug "can be used in all U.S. states, territories, and jurisdictions" based on data about variants circulating nationwide. Since Eli Lilly's combo is expected to be effective against the delta variant—and because that variant is now dominant in the United States—officials are ready to again endorse the drugs.
3rd Sep 2021 - FiercePharma

The White House wants $65 billion for an ‘Apollo’-style pandemic preparedness program

The Biden administration on Friday unveiled a sweeping new biosecurity plan, outlining a $65 billion proposal to remake the nation’s pandemic preparedness infrastructure in the wake of Covid-19. The new spending would represent one of the largest investments in public health in American history: During a press briefing, Eric Lander, the White House science adviser, likened the proposal to the Apollo program of the late 1960s. The immense funding boost would target programs aimed at developing and manufacturing vaccines, treatments, and tests more quickly. It would also provide new money for laboratory capacity, viral detection mechanisms, and early warning systems.
3rd Sep 2021 - STAT News

Crowded U.S. Jails Drove Millions Of COVID-19 Cases, A New Study Says

If the U.S. had done more to reduce its incarceration rate, it could have prevented millions of COVID-19 cases. That's the conclusion of researchers who conducted what they say is the first study to link mass incarceration rates to pandemic vulnerability. Many of those preventable cases, they add, occurred in communities of color. The U.S. jail and prison system acts as an epidemic engine, according to the study from researchers at Northwestern University and the World Bank. That engine is driven by a massive number of people who, despite some counties' efforts to trim jail populations, have been cycling between cramped detention facilities and their home communities.
2nd Sep 2021 - NPR

Covid Survivors More Likely to Have Kidney Problems, Study Finds

Since the beginning of the pandemic, doctors have found that people who become very ill with Covid-19 often experience kidney problems, not just the lung impairments that are the hallmark of the illness. Now, a large study suggests that kidney issues can last for months after patients recover from the initial infection, and may lead to a serious lifelong reduction of kidney function in some patients.
1st Sep 2021 - The New York Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Feb 2021

View this newsletter in full

China approves two more COVID-19 vaccines for wider use

China approved two more COVID-19 vaccines for wider use Thursday, adding to its growing arsenal of shots. The National Medical Products Administration gave conditional approval to a vaccine from CanSino Biologics and a second one from state-owned Sinopharm. Both are already being used among select groups of people under an emergency use authorization. China now has four vaccines to immunize its population. CanSino said its one-shot vaccine candidate is 65.28% effective 28 days after the dose is given. It can be stored at 2 degrees to 8 degrees Celsius, “making it more accessible especially to the regions with underserved public health,” it said in a statement.
25th Feb 2021 - The Independent

COVID-19: One in seven people now have coronavirus antibodies as vaccine rollout continues

One person in seven has antibodies against COVID-19, with the vaccine starting to add to the population's immunity, according to new research. Blood tests on more than 154,000 people across England showed that between 26 January and 8 February,
25th Feb 2021 - Sky News

Pfizer’s Covid-19 vaccine is 92% effective at preventing serious illness, Israeli study says

Ninety-two per cent of recipients of the Pfizer vaccine have been protected from developing severe symptoms of Covid-19, the most comprehensive study of the jab has found. The study, published in The New England Journal of Medicine, was based on data from 1.2 million patients of Israel’s largest healthcare provider, half of whom had received the Pfizer-BioNTech vaccine. It was conducted by doctors and researchers led by Professor Ran Balicer, of Israel’s Clalit Health Services, along with a team of senior researchers from Harvard University, and is the largest study of its kind.
25th Feb 2021 - The Times

California coronavirus variant is resistant to antibodies, but vaccines should still work

Early studies show the coronavirus variant that’s spreading widely across California is somewhat resistant to antibodies that fight off infection, but the vaccines still should offer plenty of protection, infectious disease experts say. Antibodies generated by the vaccines, or by previous coronavirus infection, were two to four times stronger against earlier versions of the virus compared to the new variant, scientists at UCSF found in laboratory studies. They released preliminary results this week.
25th Feb 2021 - San Francisco Chronicle

First universal coronavirus vaccine will start human trials this year

The coronavirus sweeping around the world isn’t the first to make the leap into humans and it won’t be the last. Vaccines against SARS-CoV-2 were developed in record time and are performing well. But now we urgently need a different kind of vaccine, say scientists: one that will protect us against other coronaviruses, even those we haven’t met yet.
25th Feb 2021 - New Scientist

How would COVID-19 vaccine makers adapt to variants?

How would COVID-19 vaccine makers adapt to variants? By tweaking their vaccines, a process that should be easier than coming up with the original shots. Viruses constantly mutate as they spread, and most changes aren't significant. First-generation COVID-19 vaccines appear to be working against today's variants, but makers already are taking steps to update their recipes if health authorities decide that's needed.
25th Feb 2021 - The Independent

Pfizer and BioNTech Studying Third Covid-19 Vaccine Dose to Fight New Strains

Pfizer Inc. and BioNTech SE have begun a study testing in people whether the companies’ Covid-19 shot can provide protection against emerging strains of the coronavirus. The companies said Thursday they have started the small study to see whether a third dose of their authorized Covid-19 vaccine would increase its effectiveness against new variants, such as the strain first identified in South Africa. The approach differs from that of Moderna Inc., which said Wednesday it had made a new vaccine targeting the strain found in South Africa and shipped doses to U.S. government researchers for human testing.
25th Feb 2021 - Wall Street Journal

GSK narrows focus on elderly in trial to treat pneumonia from COVID-19

GlaxoSmithKline will extend a trial testing an experimental rheumatoid arthritis drug on patients suffering from pneumonia related to COVID-19 to focus on the elderly as it seeks to firm up encouraging findings so far.
25th Feb 2021 - Reuters

Moderna sees $18.4 billion in sales from COVID-19 vaccine in 2021

Moderna Inc said on Thursday it was expecting sales of $18.4 billion from its coronavirus vaccine this year, putting it on the path to post a profit for the first time since its formation in 2010. Moderna and Pfizer Inc are the only drugmakers whose vaccines have been cleared for emergency use against COVID-19 in the United States so far. Pfizer earlier this month forecast $15 billion in its share of sales from the COVID-19 vaccine it developed jointly with partner BioNTech.
25th Feb 2021 - Reuters

England minorities: Higher COVID-19 cases, fewer vaccinated

England’s ethnic minority communities have higher levels of COVID-19 infections and lower levels of vaccine acceptance than other groups, according to a new study that highlights how the pandemic is worsening health inequalities. The study found that 92% of people across England either have received or would accept a vaccine. But that figure dropped to 87.6% for Asians and 72.5% for Blacks, according to the study released Thursday by Imperial College London. Researchers also found that most people of all age groups produced disease-fighting antibodies after two doses of the Pfizer-BioNTech vaccine.
25th Feb 2021 - The Independent

AZ to divert COVID-19 vaccines from global supply chain to meet EU target -

AstraZeneca has said it will be able to meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping up the supply from its global production network. The company released a statement saying it will meet the EU’s targets by using its global supply chain to make up for any shortfall in Europe, where it is struggling to get production up to speed. It released the statement following a Reuters report citing a European official, directly involved with talks over vaccine supply, stating less than half of the 180 million doses ordered will be delivered in the second quarter.
25th Feb 2021 - pharmaphorum

Experimental arthritis drug could prevent severe Covid-19 in over 70s, study finds

An experimental drug usually used to treat arthritis could help prevent severe coronavirus symptoms in those most at risk from the disease, a study has suggested. Otilimab was found to have a potential clinical benefit in treating the severe lung disease associated with Covid-19.
25th Feb 2021 - Wales Online

Moderna begins studying potential COVID-19 vaccine booster targeting variant first detected in South Africa

Drug manufacturer Moderna says it will begin testing a variant-specific version of its COVID-19 vaccine that would target the B1351 variant first detected in South Africa. The company has previously reported that its original two-dose vaccine — already approved for use in Canada — appears to provide protection against the B117 variant first detected in the U.K., as well as the B1351 variant, though its own research suggests it may be less effective against the latter. The company says it will study the B1351 variant-specific vaccine both as a potential booster to the original COVID-19 vaccine and as a standalone for people who have not yet received a vaccine at all.
25th Feb 2021 - CBC.ca

Why global Covid infections have plummeted

One explanation for the stubbornly high number of infections in Brazil is the role played by new variants, which can spread quickly across the population without a strict lockdown in place to contain them. Similarly in the UK, the B.1.1.7 variant spread rapidly before the current lockdown. Despite recent success in tackling the virus, scientists emphasised that all countries remained vulnerable to surges in new cases. “Any rapid relaxation of protective measures could produce spikes in infection rates,” said Ted Cohen, professor of infectious disease epidemiology at Yale University. “There are large pools of susceptible individuals still at risk.”
25th Feb 2021 - Financial Times

China approves two COVID-19 vaccines from Sinopharm's affiliate, CanSino

China's medical products regulator said on Thursday that it had approved two more COVID-19 vaccines for public use, raising the number of domestically produced vaccines that can be used in China to four. The two newly cleared vaccines are made by CanSino Biologics Inc (CanSinoBIO) and Wuhan Institute of Biological Products, an affiliate of China National Pharmaceutical Group (Sinopharm). They join a vaccine from Sinovac Biotech approved earlier this month, and another from Sinopharm's Beijing unit approved last year. Prior to formal approval for wider public use by the National Medical Products Administration, millions of doses of the two Sinopharm vaccines and Sinovac shot had been administered in China's vaccination program.
25th Feb 2021 - Reuters on MSN.com

China’s death rates didn’t rise overall at start of pandemic, study finds

In the first three months of 2020, mortality rates in Wuhan were 56 per cent higher than estimates based on average in previous years. But elsewhere they were lower than expected, which researchers said may be related to behavioural changes during lockdown
25th Feb 2021 - South China Morning Post

In boost for COVID-19 battle, Pfizer vaccine found 94% effective in real world

The first big real-world study of the Pfizer/BioNTech vaccine to be independently reviewed shows the shot is highly effective at preventing COVID-19, in a potentially landmark moment for countries desperate to end lockdowns and reopen economies. Up until now, most data on the efficacy of COVID-19 vaccines has come under controlled conditions in clinical trials, leaving an element of uncertainty over how results would translate into the real world with its unpredictable variables. The research in Israel – two months into one of the world’s fastest rollouts, providing a rich source of data – showed two doses of the Pfizer shot cut symptomatic COVID-19 cases by 94% across all age groups, and severe illnesses by nearly as much.
25th Feb 2021 - EURACTIV

Three-shot combo? Pfizer, BioNTech roll COVID-19 booster trial as real world data back first vaccine

As Pfizer and BioNTech start testing whether a third dose of their COVID-19 shot can help fend off new coronavirus variants, a massive real-world study has confirmed that its first, two-dose regimen is 94% effective. The third-dose study now underway will gauge the effects of that follow-up dose on circulating and new COVID-19 virus variants. At the same time, the companies are in talks with the FDA and EMA about studying a new booster specifically designed to tackle new variants. They're hoping to validate "future modified mRNA vaccines with a regulatory pathway similar to what is currently in place for flu vaccines,” according to a press release.
25th Feb 2021 - FiercePharma

Researchers find worrying new coronavirus variant in New York City

Two separate teams of researchers said this week they have found a worrying new coronavirus variant in New York City and elsewhere in the Northeast that carries mutations that help it evade the body's natural immune response -- as well as the effects of monoclonal antibody treatments. Genomics researchers have named the variant B.1.526. It appears in people affected in diverse neighborhoods of New York City, they said, and is "scattered in the Northeast." One of the mutations in this variant is the same concerning change found in the variant first seen in South Africa and known as B.1.351. It appears to evade, somewhat, the body's response to vaccines, as well. And it's becoming more common.
25th Feb 2021 - CNN

BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

All persons who were newly vaccinated during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic Covid-19, Covid-19–related hospitalization, severe illness, and death. We estimated vaccine effectiveness for each outcome as one minus the risk ratio, using the Kaplan–Meier estimator.
24th Feb 2021 - nejm.org

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Feb 2021

View this newsletter in full

COVID-19 variant spreading in New York City has mutation that may weaken effect of vaccines

B.1.526 variant first appeared in samples collected in New York City in November It now accounts for about 27 percent of viral sequences in databases used by scientists. Scientists have identified two versions of the B.1.526 variant, which are lumped together for now. One of the B.1.526 variants has the E484K mutation which scientists believe help the virus partially avoid the vaccine effects. The other has the S477N mutation which may optimize the binding process with human cells to possibly increase infection rates
25th Feb 2021 - Daily Mail

FDA says Johnson & Johnson’s single-dose shot protects against COVID-19

Johnson & Johnson’s single-dose vaccine offers strong protection against severe COVID-19, according to an analysis by U.S. regulators Wednesday that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic. The Food and Drug Administration’s scientists confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness. The agency also said J&J’s shot — one that could help speed vaccinations by requiring just one dose instead of two — is safe to use.
24th Feb 2021 - PBS

Covid-19 can survive on clothing for up to THREE DAYS - with polyester garments sustaining the virus the longest, scientists warn

Coronaviruses similar to Covid-19 can survive on clothing for up to three days, according to new research. Research carried out by De Montfort University (DMU) in Leicester looked at how a coronavirus behaves on three fabrics commonly used in the healthcare industry. Polyester enables the virus to survive at infectious levels for up to 72 hours, whereas it dies within 24 hours on 100 per cent cotton.
24th Feb 2021 - Daily Mail

Sanofi and GSK start new study of COVID-19 vaccine

Sanofi and GlaxoSmithKline (GSK) have announced the initiation of a new Phase II study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate. If results of the study are positive, the Phase III study will start this year in Q2, with the vaccine expected to be available later in the year in Q4. In parallel to the new Phase II study and recognising the global emergence of new SARS-CoV-2 variants and their potential impact on vaccine efficacy, Sanofi has commenced development work against new variants which will be used to inform the next stages of the Sanofi/GSK development programme.
24th Feb 2021 - Pharmafield

Johnson & Johnson’s single-dose vaccine ‘protects against Covid-19’

Johnson & Johnson's single-dose vaccine protects against Covid, according to an analysis by US regulators. The vaccine is about 66 per cent effective overall at preventing moderate to severe Covid-19, a report on Wednesday by the Food and Drug Administration confirmed. It will now go forward to a panel of FDA experts who will debate if the evidence is strong enough to recommend the vaccine. The FDA is expected to make a final decision within days.
24th Feb 2021 - Evening Standard

Covid-19: First doses of vaccines in Scotland led to a substantial fall in hospital admissions

Rollout of the Pfizer BioNTech and Oxford AstraZeneca vaccines has led to a substantial fall in severe covid-19 cases requiring hospital admission in Scotland, suggest the results of the first study to report on the impact of the UK’s vaccination strategy.1 - The results, available as a preprint, showed that four weeks after the first doses of the Pfizer BioNTech and Oxford AstraZeneca vaccines were administered the risk of hospitalisation from covid-19 fell by up to 85% (95% confidence interval 76 to 91) and 94% (95% CI 73 to 99), respectively.
24th Feb 2021 - The BMJ

China's bid to stop Wuhan COVID-19 spread cut deaths from other causes: study

The number of deaths in China - excluding the coronavirus epicentre of Wuhan - fell slightly during the first three months of 2020, suggesting efforts to control the spread of COVID-19 reduced fatalities from other causes, a new study showed. Researchers from the University of Oxford and the Chinese Center for Disease Control and Prevention (CDC) analysed official death registry data from Jan. 1 to March 31 last year for changes in overall and cause-specific deaths. The death rate in Wuhan, the central Chinese city where the SARS-CoV-2 coronavirus was first identified, stood at 1,147 per 100,000 over the period, 56% higher than expected, they found in the study published on Wednesday by BMJ, the journal of the British Medical Association.
24th Feb 2021 - Yahoo News Singapore

Real-world trial of Pfizer COVID vaccine finds high 2-dose, good 1-dose protection

A large observational, real-world study from Israel estimates that the Pfizer/BioNTech COVID-19 vaccine is 46% effective at preventing infection 14 to 20 days after the first dose and 92% 7 days after the second dose, backing the results of an earlier randomized, controlled trial, according to a study today in the New England Journal of Medicine (NEJM). A single dose, however, was 74% effective against COVID-related hospitalization and 72% effective at preventing death.
24th Feb 2021 - CIDRAP

US ready to distribute J&J COVID vaccine, White House says

Today leaders of the White House COVID-19 response team said they are ready to distribute Johnson & Johnson's COVID-19 vaccine when and if the Food and Drug Administration (FDA) issues an emergency use authorization (EUA)—which could come as early as this weekend. "We are doing the work so if the EUA is granted we will waste no time in getting life-saving vaccines into the arms of Americans," said Jeff Zients, the Biden administration's COVID-19 czar during today’s press conference on response efforts.
24th Feb 2021 - CIDRAP

Moderna sends COVID-19 booster shot for NIH testing as it hikes production targets past 2B doses

Moderna on Wednesday said it's now on track to produce 700 million vaccine doses this year, and it's still aiming for 1 billion at the high end. Last year, the company had said 500 million would be its minimum output this year, and it ratcheted up that minimum to 600 million in January. And for 2022, the biotech is planning for 1.4 billion doses—or perhaps even 2 billion, depending on the dose required for booster shots targeting new variants. The company has shipped a booster candidate to the National Institutes of Health for testing, according to Wednesday's statement; it's targeted specifically at the South Africa variant now worrying public health experts.
24th Feb 2021 - FiercePharma

Mission Possible: Pfizer and BioNTech star in their own vaccine discovery movie

The movie-length product placement is a behind-the-scenes look at Comirnaty, the now-authorized coronavirus shot Pfizer developed and produced in concert with its partner BioNTech. Pfizer provided the National Geographic's scientific storytellers “unprecedented access” to the vaccine's development, said Sally Susman, Pfizer executive VP and chief of corporate affairs, said. “This film is riveting and suspenseful,” Susman said in a media backgrounder from Disney Advertising Sales, the Disney group that oversees National Geographic’s CreativeWorks branded content studio, which created the film. “It is a testament to all of our employees and partners across the biopharmaceutical industry who have put in the long hours of tireless dedication and sacrifice, often working away from their families."
24th Feb 2021 - FiercePharma

Moderna ready to test version of Covid-19 vaccine aimed at worrisome variant

Moderna is pressing forward with a modified version of its Covid-19 vaccine meant to protect against an emerging strain of the virus, the company said Wednesday, planning to start a clinical trial as soon as regulators give the green light. Laboratory tests have suggested that Moderna’s authorized vaccine confers less protection against the variant, known as B.1.351, than it does against other strains. Pfizer has reported similar findings with its vaccine, and human trials conducted by Johnson & Johnson and Novavax suggest vaccines designed for the original strain of SARS-CoV-2 are less effective against B.1.351 as well. Moderna said it is seeking to test the novel vaccine on its own and as a combined shot with its current vaccine. It also plans to test whether giving a booster of the current vaccine on its own will give enhanced protection against new variants of the virus that causes Covid-19.
24th Feb 2021 - STAT News

Pfizer-BioNTech vaccine performs as well in the real world as in clinical trials, new study concludes

Pfizer and BioNTech’s Covid-19 vaccine performed as well in the real world as it did in the clinical trial that led to its use, a large study conducted in Israel concluded. The study, published Wednesday in the New England Journal of Medicine, is the largest to date assessing the effectiveness of the vaccine, comparing all illness, severe illness, and hospitalizations as well as deaths between 600,000 pairs of vaccinated and unvaccinated people. That a vaccine will perform as well in the real world as it does in the highly controlled setting of a clinical trial is not a given, noted senior author Ran Balicer, director of the Clalit Research Institute of Israel.
24th Feb 2021 - STAT News

FDA scientists endorse J&J’s Covid vaccine, as new data shed light on efficacy

Scientists at the Food and Drug Administration said Wednesday that the single-shot Covid-19 vaccine developed by Johnson & Johnson is effective and prevents hospitalizations from the disease. Johnson & Johnson also revealed new, encouraging data showing the vaccine may do a better-than-expected job at protecting patients against new variants of the virus that causes disease. At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.
24th Feb 2021 - STAT News

Moderna to begin clinical trials of a booster shot to protect against the South African variant

Moderna says it has shipped boosters shots of its COVID-19 vaccine, designed to protect against the South African variant, to the NIH for clinical trials. A study found Moderna's two-dose regimen had a six-fold decrease in antibody response against the variant that other common versions of the virus. Several studies suggest have suggested the variant, known as B.1.351, is more resistant to existing vaccines than other variants of the coronavirus. In the U.S., there are 46 confirmed cases of the variant across 14 states. It comes as Moderna announced it is raising its expected global vaccine production for 2021 from 600 million to 700 million
24th Feb 2021 - Daily Mail

Brits could get their Covid vaccine in a PILL in future, Oxford University says

Professor Sarah Gilbert said team were exploring new ways to deliver vaccine Also looking at whether it could be given via a nasal spray, like flu sometimes is It could help alleviate supply issues that have hindered rollouts internationally
24th Feb 2021 - Daily Mail

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Feb 2021

View this newsletter in full

Drug supply chain issues aren't going away, report says

The first chapter of the ninth edition of ASHP's pharmacy forecast, which was released earlier this month, is called, "The Certainty of Uncertainty for a Global Supply Chain." Written by Erin Fox, PharmD, and Aaron Kesselheim, MD, JD, MPH, the section reflects on responses to an ASHP survey from 272 experts in health-system pharmacy. Allocation guides, a push for domestic supply chains, manufacturing quality scrutiny, and more were all topics the panelists thought would be highly relevant for the next 5 years, and the authors agree. "With a global pandemic and continuing uncertainty regarding the stability and quality of the medication supply chain, health-system pharmacists must be prepared for significant disruptions to 'normal' healthcare delivery, including disruption of medication procurement," they write.
24th Feb 2021 - CIDRAP

Sanofi and GSK begin new study of their COVID-19 vaccine

The new Phase II study will involve 720 volunteers aged 18 years and over, and will include equal numbers of adults aged 18 to 59 years and those 60 years and above. The study will test three different antigen doses with a fixed dose of adjuvant in the total study population, at sites in the US, Honduras and Panama. Sanofi/GSK said in a statement that results of the Phase II trial will inform the Phase III protocol, adding that if data from the new trial is positive, a global late-stage trial could begin in the second quarter of 2021. Depending on the outcome of the potential Phase III trial, regulatory submissions for the vaccine could be expected in the second half of 2021, with the vaccine likely to then be available in Q4 2021 if approved.
23rd Feb 2021 - PharmaTimes

Sanofi to provide manufacturing support to Johnson & Johnson for their COVID-19 vaccine to help address global supply demands

Sanofi has entered into an agreement with Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson, under which Sanofi will support manufacturing of Janssen´s COVID-19 vaccine in order to address the COVID-19 pandemic and supply needs. Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization for its single-dose Janssen COVID-19 vaccine candidate and an application for conditional marketing authorisation to the European Medicines Agency.
23rd Feb 2021 - PharmiWeb

Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints

Sanofi and GlaxoSmithKline on Monday announced the start of a Phase 2 study testing a new version of the experimental coronavirus vaccine the two partners have been developing. The 720-volunteer mid-stage study begins roughly two months after the partners disclosed weaker than expected results for their first vaccine candidate. Sanofi and GSK are evaluating a "refined antigen formulation" in the new trial, and could start Phase 3 testing in the second quarter if results are positive, they said in a statement. If all goes well, Sanofi and GSK hope to bring a vaccine to market by the fourth quarter of 2021. But that outcome would still represent a six-to-nine month delay from previous estimates, a significant setback for a program that was promised up to $2.1 billion in funding from the U.S. government. Multiple coronavirus vaccines are already available, and others could arrive later this year.
23rd Feb 2021 - BioPharma Dive

Covid-19 could become disease of the poor and persist in some areas of UK, expert warns

Dr Mike Tildesley, reader in mathematical modelling of infectious diseases at the University of Warwick and member of the Government advisory group SPI-M, said that he was "concerned" that the virus might persist particular parts of the country. Asked on BBC Radio 4's Today programme whether Covid-19 could remain a "disease of the deprived", he said: "This is a real concern actually for me and I know a number of other scientists have raised this, that we may end up in a situation where we have the 'vaccine rich' and as it were, who are able to access the vaccine who have taken up the vaccine and are at much lower risk.
23rd Feb 2021 - Mirror Online

Fauci: Vaccinated people shouldn't dine indoors or go to the theater quite yet

Dr. Anthony Fauci cautions against indoor dining and theatergoing even for those fully vaccinated. The number of coronavirus cases in the US remains high. He said it'd be safer to gather indoors again as more people get vaccinated and COVID-19 cases drop.
23rd Feb 2021 - Business Insider

Covid-19: Vaccine success drives England's lockdown exit

Siren study - The Pfizer and BioNTech covid-19 vaccine is at least 70% effective against symptomatic and asymptomatic infection 21 days after the first dose and at least 85% seven days after the second dose, shows a UK study of healthcare workers. The Siren study previously investigated the effect of prior infection on protection against reinfection but has now been amended to investigate vaccine effectiveness. The first results following this update have looked at the eight weeks after the first Pfizer-BioNTech vaccine dose.
23rd Feb 2021 - The BMJ

Italy 'misled WHO on pandemic readiness' weeks before Covid outbreak

Italy allegedly misled the World Health Organization (WHO) on its readiness to face a pandemic less than three weeks before the country’s first locally transmitted coronavirus case was confirmed. Each year, countries bound by the International Health Regulations (IHR) – an international treaty to combat the global spread of disease – are required to file a self-assessment report to the WHO on the status of their preparedness for a health emergency.
23rd Feb 2021 - The Guardian

Heads of COVID vaccine firms promise dose ramp-up

Today during a House Committee on Energy & Commerce hearing, chief executives from Pfizer, Moderna, Johnson & Johnson, AstraZeneca, and Novovax addressed US lawmakers for the first time since July 2020 on the production of vaccines and when Americans could expect more doses. According to Richard Nettles, MD, vice president of US medical affairs for Johnson & Johnson's Janssen division, his company will be able to immediately ship vaccine doses upon a Food and Drug Administration (FDA) emergency use authorization (EUA). An FDA advisory board meets on Feb 26 to consider granting an EUA to Johnson & Johnson.
23rd Feb 2021 - CIDRAP

Adults with Down syndrome 3 times more likely to die of COVID, study finds

Adults older than 40 with Down syndrome are about three times more likely to die of COVID-19 than the rest of the population, pointing to the need to prioritize coronavirus vaccination to this group, a study published yesterday in the Lancet's EClinicalMedicine has found. A team led by Emory University researchers conducted the international online survey of the clinicians or caregivers of 1,046 patients with Down syndrome diagnosed as having COVID-19 from April to November 2020.
23rd Feb 2021 - CIDRAP

COVAX vaccine begins shipping from India facility

The World Health Organization's (WHO's) South East Asia office said on Twitter today that the first batches rolled out from India's Serum Institute in Pune. The move comes a week after the WHO listed versions of the AstraZeneca-Oxford vaccine made in India and South Korea for emergency use, which paves the way for the vaccine to be distributed by the COVAX program. The vaccines required two separate reviews and approvals, because they are made in two different facilities.
23rd Feb 2021 - CIDRAP

Pfizer, Moderna and J&J tout supercharged COVID-19 vaccine output, eyeing nearly 140 million new doses by March

Pfizer, which has been shipping 4 million to 5 million doses per week, plans to increase that to 13 million a week by mid-March, according to executive testimony planned for Tuesday morning's hearing before the House Energy and Commerce Committee's oversight arm. J&J, which reportedly had just 2 million doses in stock last week, should be able to ship 20 million by March 31—provided it wins FDA authorization as expected, Richard Nettles, M.D., vice president of U.S. medical affairs at Janssen’s infectious diseases and vaccines unit, said in his testimony. The shot is up for an FDA panel review later this week. And Moderna, which already doubled its monthly deliveries to the feds this year and has so far supplied 45 million doses of its mRNA vaccine, aims to double monthly deliveries again by April, president Stephen Hoge's testimony states.
23rd Feb 2021 - FiercePharma

Pfizer eyes higher prices for COVID-19 vaccine after the pandemic wanes: exec, analyst

Amid the high-stakes fight against COVID-19, a company at the forefront of the vaccine effort is laying plans to hike prices after the crisis. A top Pfizer exec said the drugmaker aims to charge more after the "pandemic pricing environment," and an influential analyst says the company could be eying prices 3 to 4 times higher. On an earnings call earlier this month, CFO Frank D’Amelio said that “obviously,” the company is “going to get more on price” after the “pandemic pricing environment." He was speaking in response to Bank of America Merrill Lynch analyst Jason Zemansky, who asked the management team about how profit margins for the program could change over time.
23rd Feb 2021 - FiercePharma

UK, US to achieve herd immunity in 2021, but not EU: Report

The United States and the United Kingdom are on course to achieve herd immunity against COVID-19 by the end of 2021 given the speed of their mass vaccination programmes, but key European Union nations are not, according to a new report. The German database firm Statista studied the number of COVID-19 vaccines that were given on a daily basis, using recent data from local health authorities of each country.
23rd Feb 2021 - FiercePharma

Not to be sniffed at: Agony of post-COVID-19 loss of smell

The doctor slid a miniature camera into the patient’s right nostril, making her whole nose glow red with its bright miniature light. “Tickles a bit, eh?” he asked as he rummaged around her nasal passages, the discomfort causing tears to well in her eyes and roll down her cheeks. The patient, Gabriella Forgione, wasn’t complaining. The 25-year-old pharmacy worker was happy to be prodded and poked at the hospital in Nice, in southern France, to advance her increasingly pressing quest to recover her sense of smell. Along with her sense of taste, it suddenly vanished when she fell ill with COVID-19 in November, and neither has returned.
23rd Feb 2021 - The Associated Press

UK data: COVID-19 vaccines sharply cut hospitalizations

Two U.K. studies released Monday showed that COVID-19 vaccination programs are contributing to a sharp drop in hospitalizations, boosting hopes that the shots will work as well in the real world as they have in carefully controlled studies. Preliminary results from a study in Scotland found that the Pfizer-BioNTech vaccine reduced hospital admissions by up to 85% four weeks after the first dose, while the Oxford-AstraZeneca shot cut admissions by up to 94%. In England, preliminary data from a study of health care workers showed that the Pfizer vaccine reduced the risk of catching COVID-19 by 70% after one dose, a figure that rose to 85% after the second.
22nd Feb 2021 - The Associated Press

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Feb 2021

View this newsletter in full

‘Extremely promising’: 1st dose of COVID vaccine cuts illness

Data from two separate studies published in the UK, one in England and another in Scotland, have shown vaccines against COVID-19 are effective in cutting disease transmission and hospitalisations starting from the first dose. Analysis from Public Health England (PHE) published on Monday shows that the vaccine manufactured by Pfizer-BioNTech reduces the risk of catching infection by more than 70 percent after the first dose. That risk is reduced by 85 percent after a second dose.
23rd Feb 2021 - Al Jazeera English

Novavax vaccine could be approved by JUNE - bringing another 100 million doses of COVID-19 vaccine to the US after drug company announced its final stage clinical trial in ...

Novavax has now enrolled 30,000 people in the US and Mexico to its shot trial Its CEO told Reuters last month it could deliver doses to the US by June if all goes well in its trials. The vaccine was shown to be 89.3% effective and works nearly as well against the UK variant in tests in Britain. But the shot is about 50% less effective against the South African variant. US has a contract for 100 million doses of Novavax's COVID-19 vaccine. It would likely be the fourth shot authorized in the US, assuming Johnson & Johnson's vaccine gets greenlit by the FDA this week
22nd Feb 2021 - Daily Mail

Covid-19 Pfizer vaccine cuts chance of hospitalisation for elderly by 75% after one jab, research finds

One dose of the Pfizer vaccine slashes the chances of being admitted to hospital with Covid by at least 75 per cent among over-80s, real-world data from Public Health England (PHE) has found.Dr Mary Ramsay, head of immunisation at PHE, said this was at the “lower end of the estimate” and the drop in hospital admissions and deaths was thought to be even more profound. Another study found that the Pfizer/BioNTech jab also offered a high degree of protection for younger age groups.
22nd Feb 2021 - i on MSN.com

COVID-19: Vaccine rollout linked to 85% and 94% drop in coronavirus hospital admissions in Scotland, study shows

The COVID-19 vaccines being used in the UK could reduce a person's risk of being admitted to hospital by as much as 94% four weeks after the first dose, new data suggests. Experts examined coronavirus hospital admissions in Scotland among people who have had their first jab and compared them to those who had not yet received a vaccine.
22nd Feb 2021 - Sky News

Why this week's FDA meeting on J&J's coronavirus vaccine will be important

This Friday, a group of vaccine and infectious disease experts will assemble virtually to discuss whether the Food and Drug Administration should clear Johnson & Johnson's coronavirus vaccine for emergency use. The meeting, convened by the FDA, is likely one of the last steps in the agency's review of J&J's shot. The regulator held similar meetings to review study results from Pfizer and Moderna and, each time, authorized the companies' vaccines the very next day. The advisers are expected to support emergency use of J&J's vaccine, as they did for Pfizer's and Moderna's. But Friday's meeting will be important viewing nonetheless, as the experts are likely to debate emerging issues like protection against new virus variants. The meeting will be broadcast through an FDA conference system as well as on Youtube. BioPharma Dive will be covering live.
22nd Feb 2021 - BioPharma Dive

Sanofi and GSK start test of upgraded coronavirus vaccine after first version disappoints

U.K. Data Trove Shows Vaccine Program Cuts Covid-19 Hospitalizations, Deaths

A single shot of the vaccine produced by Pfizer led to a 57% reduction in cases of Covid-19 in people of age 80 and over, rising to 88% after a second dose, according to preliminary data from the U.K.
22nd Feb 2021 - Wall Street Journal

Clinical trials offer new hope for Covid-19 treatment

Clinical trials are taking place at the Great Western Hospital with the aim of finding more effective ways to treat patients with coronavirus. Operating department practitioner Helen Langton explains how her team approaches patients and families to get their consent.
22nd Feb 2021 - BBC News

COVID-19 survivors may only need one vaccine dose, study finds

Researchers looked at blood samples of 10 people previously infected with coronavirus who received one shot of the Pfizer-BioNTech or Moderna vaccine COVID-19 survivors had boosted levels of immune system cells and a 1,000-fold increase in levels of neutralizing antibodies. The levels were enough to neutralize both the original strain of the virus and the South African variant that is more highly contagious. Dr Anthony Fauci said the data is 'impressive' and that - if it holds up - health officials may consider letting survivors get one dose
22nd Feb 2021 - Daily Mail

Blood thinners may protect against COVID-19 complications

A new study has found that administering heparin-based blood thinners to patients with COVID-19 in the first 24 hours of hospital admission reduced the risk of death. The researchers observed a 27% reduced risk of 30-day mortality among patients who received blood thinners. Severe bleeding that required a blood transfusion occurred in 4.6% of patients and was not significantly linked with early intervention to prevent coagulation.
22nd Feb 2021 - Medical News Today

This UK lockdown must be the last. Here's how we can achieve that

As the UK has yo-yoed in and out of multiple lockdowns, restrictions have harmed people’s livelihoods, businesses, mental and physical health, and their quality of life. In the first and second lockdowns, these restrictions proved insufficient to permanently drive down the prevalence of Covid-19. This time, we have been promised that all adults will have received their first vaccine dose by July – but its level of effectiveness, coupled with the potential emergence of new strains of the virus, means the vaccine rollout will not be a complete solution to the pandemic.
22nd Feb 2021 - The Guardian

Delaying 2nd AstraZeneca COVID shot may boost efficacy

A single dose of the AstraZeneca/Oxford vaccine offered 76% protection against COVID-19 for 3 months, at which time administering the second dose resulted in up to 47% greater protection than giving it at 6 weeks, according to a study published late last week in the Lancet. The pooled post-hoc exploratory analysis of four randomized, controlled trials led by researchers from Oxford University involved 17,178 adults in the United Kingdom, Brazil, and South Africa from Apr 23 to Dec 6, 2020. The study also examined the effect of one versus two doses of the vaccine in reducing community spread of COVID-19 and the protection conferred by a low dose followed by a standard dose versus two standard doses.
22nd Feb 2021 - CIDRAP

AstraZeneca's Indian COVID-19 vaccine partner told to prioritize local supplies: CEO

Low- and middle-income countries banking on doses of AstraZeneca’s COVID-19 vaccine from Serum Institute of India may have to wait a bit longer, the Indian shot maker’s CEO said over the weekend. The same goes for Europe, where officials have reportedly considered importing supplies from the world's largest vaccine maker by doses. Serum Institute has been told to prioritize supplies for India first as the country hustles to vaccinate 300 million people, or a fifth of its population, by August. The move could signal delays for other countries waiting on orders of AstraZeneca’s adenovirus shot, which Serum Institute is cranking out on license under the name Covishield.
22nd Feb 2021 - FiercePharma

After Pfizer deal, Sanofi offers a hand to Johnson & Johnson for COVID-19 vaccine production

Sanofi hasn't abandoned its COVID-19 vaccine hopes despite a setback in the high-stakes race, but as it moves two different shots forward, it's also pitching in to make doses for its usual rivals. The drugmaker on Monday inked a manufacturing tie-up with Johnson & Johnson to help produce that company’s vaccine in Europe. The deal follows a separate agreement for Sanofi to turn out 100 million doses of the Pfizer-BioNTech vaccine for Europe this year. When J&J's one-dose-and-done vaccine scores an authorization, Sanofi will give the company access to its plant in Marcy l’Etoile, France. Workers there will formulate the J&J vaccine and fill vials, and the site will turn out around 12 million doses per month, Sanofi said. The deal “demonstrates Sanofi’s ongoing commitment to the collective effort to ending this crisis as quickly as possible,” CEO Paul Hudson said in a statement.
22nd Feb 2021 - FiercePharma

US: South African COVID strain found in New York state resident

The first case of a fast-spreading coronavirus variant from South Africa has been discovered in a resident of the US state of New York, Governor Andrew Cuomo said. Cuomo said on Sunday the case, a person from Nassau County, was detected at the Opentrons Labworks Inc’s Pandemic Response Lab. The mutated strain of the coronavirus, which was first detected in South Africa, was first discovered in the US last month.
22nd Feb 2021 - Al Jazeera English

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Feb 2021

View this newsletter in full

Pfizer vaccine ‘highly effective’ in reducing coronavirus transmission, study suggests

New data from Israel suggests vaccine is 89.4 per cent effective at preventing infections, whether symptomatic or not
21st Feb 2021 - The Independent

Continent’s medics boycott Oxford jab as Europe talks down efficacy

Europe’s faltering immunisation programme has been hit by a boycott of the Oxford-AstraZeneca vaccine by medical staff concerned about its side effects and doubtful of its efficacy against new variants of Covid-19. Health workers in France and elsewhere in the EU are declining the Anglo-Swedish vaccine, increasingly portrayed in European media as a cheap and inferior alternative to the mRNA jabs made by Pfizer-BioNTech and Moderna.
22nd Feb 2021 - The Times

Pfizer-BioNTech Shot Stops Covid Spread, Israeli Study Shows

The Pfizer Inc. and BioNTech SE Covid-19 vaccine appeared to stop the vast majority of recipients in Israel becoming infected, providing the first real-world indication that the immunization will curb transmission of the coronavirus. The vaccine, which was rolled out in a national immunization program that began Dec. 20, was 89.4% effective at preventing laboratory-confirmed infections, according to a copy of a draft publication that was posted on Twitter and confirmed by a person familiar with the work. The companies and Israel’s Health Ministry worked together on the preliminary observational analysis, which has not yet been peer-reviewed.
22nd Feb 2021 - Bloomberg

The ticket to a return of clubs, gigs and football matches? Five-minute coronavirus test made in the UK is touted as 'game-changer' in unlocking live events

Yorkshire firm Avacta have developed a new super-fast lateral flow Covid test Understood to be in last test stage at Government top-secret Porton Down lab The test's developers say it is more accurate and faster than the US devices It is hoped that 5-minute rapid testing will be used on admission to large events
21st Feb 2021 - The Times

Sage expert calls for children to get Covid jab as schools set to reopen

Pressure is mounting on the government to prove it is safe for children to return to the classroom before it reopens schools, as one of the UK government’s scientific advisers warned that the plan could lead to a resurgence of coronavirus. In a last-minute plea before Boris Johnson announces on Monday details of plans to reopen schools in England on 8 March, unions, experts and some opposition MPs, have demanded the publication of scientific evidence informing the government’s decision.
21st Feb 2021 - The Guardian

The inside story of how the Oxford vaccine was made and the team behind it

How an email to a scientist in her pyjamas began an astonishing story — the creation of a groundbreaking vaccine in less than 12 months. Over the past year Andrew Pollard, director of the Oxford Vaccine Group, has been tackling a daunting a mission: to develop a life-saving vaccine against Covid-19. It involved “logistics, teamwork and resilience”, he says. Approval of the vaccine for use in the UK, which was granted on December 30, was in some ways the summit denied him on Everest in 1994 when hw was part of the group that just fell short.
21st Feb 2021 - The Times

Pfizer, Moderna vaccines have reduced effectiveness against South African variant, studies show

President Biden hesitated in giving a specific timeline for when every American will be able to get a vaccine and when the country will be able to return to normalcy. During a visit to the Pfizer vaccine manufacturing facility in Michigan on Friday, the president said he wanted to be “straight” with the American people and explained that issues such as weather events, emerging virus mutations and manufacturing delays could pose significant challenges to the vaccination process.
20th Feb 2021 - The Washington Post

Pfizer and BioNTech Coronavirus Vaccine Effective After 1 Dose, Can Last 2 Weeks in Standard Freezer, Separate Research Shows

On Friday, Pfizer and BioNTech announced that they have submitted new data about their BNT162b2 vaccine to the Food and Drug Administration. With this submission, the two companies hope that the FDA will update the emergency use authorization (EUA) it has granted the vaccine. The new data indicates that Pfizer and BioNTech's BNT162b2 can be kept for as long as two weeks at temperatures common to pharmaceutical freezers and refrigerators, as opposed to the constant ultra-low temperature storage it initially seemed to necessitate.
20th Feb 2021 - The Motley Fool

Russia approves 3rd coronavirus vaccine before late-stage trials begin, PM says

Russia on Saturday approved a third coronavirus vaccine for domestic use, Prime Minister Mikhail Mishustin said on state TV, though large-scale clinical trials of the shot, labeled CoviVac and produced by the Chumakov Centre, have yet to begin. Russia has already approved two COVID-19 vaccines, including the Sputnik V shot, developed by Moscow’s Gamaleya Institute, following a similar approach of granting approval before seeing any late-stage trial results.
20th Feb 2021 - Global News

How Google search data can predict COVID-19 outbreaks

New research finds that online searches can accurately predict regional increases and decreases in COVID-19 cases. Certain types of searches reveal the activities in which people plan to engage. The search volume for outside-the-home vs. stay-at-home activities forecasts the number of COVID-19 diagnoses 10–14 days later.
20th Feb 2021 - Medical News Today

Association between mental illness and COVID-19 in South Korea

In their nationwide cohort study, Seung Won Lee and colleagues suggest that patients with a severe mental illness had a slightly higher risk for severe clinical outcomes of COVID-19.1 Although the authors classified region of residence into urban and rural categories to adjust for potential confounding, the high number of COVID-19 cases in Daegu (the fourth most populous city in South Korea) indicates that bias could remain due to uncontrolled confounding as a result of regional differences.
20th Feb 2021 - The Lancet

Italian doctors remember night that ushered in Europe's first COVID-19 lockdown

A year ago, Laura Ricevuti and Annalisa Malara, both doctors at Codogno hospital in Italy, had a hunch that something was different about a patient in the intensive care ward. Their decision to take matters into their own hands wound up triggering a national emergency - they had identified the first case of COVID-19 in the area that would become Europe’s first lockdown zone. A previously healthy 38-year-old man, now known as Mattia, his first name, or “patient one”, had gone to the hospital with a high fever, cough and shortness of breath on Feb. 18, 2020. He refused to be admitted so was given antibiotics and went home.
20th Feb 2021 - Reuters

Elon Musk Got 4,000 SpaceX Workers to Join a Covid-19 Study. Here’s What He Learned.

To monitor the prevalence of the virus among SpaceX workers nationwide, Mr. Musk and the rocket company’s top medical executive worked with doctors and academic researchers to build an antibody-testing program. More than 4,000 SpaceX workers volunteered for monthly blood tests. This week the group published its findings, which suggest that a certain threshold of antibodies might provide people lasting protection against the virus. Mr. Musk is listed as a co-author of the peer-reviewed study, which appears in the journal Nature Communications. “People can have antibodies, but it doesn’t mean they are going to be immune” to Covid-19, said Galit Alter, a co-author of the study who is a member of the Ragon Institute of MGH, MIT and Harvard. Individuals who experienced fewer, milder Covid-19 symptoms generated fewer antibodies and were therefore less likely to meet the threshold for longer-term immunity, the study found.
20th Feb 2021 - The Wall Street Journal

Mental anguish in COVID-19 survivors, young US adults

A research letter by Italian investigators published yesterday in JAMA Psychiatry details a study of 381 patients in Rome who had sought emergency care for COVID-19 and were given a psychiatric assessment 1 to 4 months after recovery, from Apr 21 to Oct 15, 2020. One-hundred-fifteen of 381 patients (30.2%) were diagnosed as having PTSD, while 17.3% had depression, 7.0% had generalized anxiety disorder, 0.7% were hypomanic, and 0.2% were psychotic. Women made up 55.7% of the PTSD diagnoses, and patients with PTSD reported higher rates of a history of psychiatric disorders (34.8%) and delirium or agitation when ill (16.5%) and the persistence of more than three coronavirus-related symptoms after recovery from infection (62.6%).
19th Feb 2021 - CIDRAP

To get ahead of variants, Covid-19 drug makers use evolutionary biology as a guide

Before becoming a Covid-19 drug, each candidate was just a tiny fragment of someone’s immune system, part of a swarm of Y-shaped proteins unleashed to try to keep the coronavirus from invading more cells. If the person recovered, these antibodies might end up in a blood sample in a lab. Some proved more effective than others. Yet even as researchers pinpointed the best of the bunch as possible medications, they knew their power could wane: What worked against the coronavirus as it was last year could falter as the pathogen evolved.
19th Feb 2021 - Stat News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Feb 2021

View this newsletter in full

Zambia study casts doubt on the assumption that COVID-19 skipped Africa

A new study concluding out of Lusaka, Zambia last summer has found that as many as 19% (almost 1 in 5) of recently-deceased people tested positive for COVID-19. A new Boston University School of Public Health (BUSPH) study in Lusaka, Zambia's capital, challenges the common belief that Africa somehow "dodged" the COVID-19 pandemic. The findings indicate that low numbers of reported infections and deaths across Africa may simply be from lack of testing, with the coronavirus taking a terrible but invisible toll on the continent. Published in The BMJ, the study found that at least 15% and as many as 19% of recently-deceased people arriving at Lusaka's main morgue over the summer had the coronavirus, peaking at 31% in July. Despite most having had COVID symptoms, few were tested before death.
19th Feb 2021 - News-Medical.net

Japan finds more than 90 cases of new COVID-19 virus strain: media

Japanese health authorities have found more than 90 cases of a new strain of the COVID-19 virus, the Mainichi newspaper reported on Friday. The variant is believed to have come from overseas but is different from strains that originated in Britain and South Africa, according to the report which cited Japan’s National Institute of Infectious Diseases. Japan has reported 151 cases of variants from Britain, South Africa and Brazil, according to the health ministry. The nation has had more than 400,000 cases of COVID-19 with 7,194 fatalities.
19th Feb 2021 - Reuters

Pfizer to test COVID-19 vaccine engineered for South African variant

A top Pfizer Inc scientist said on Thursday the company is in intensive discussions with regulators to test a booster shot version of its coronavirus vaccine specifically targeted for a highly contagious variant that is spreading widely in South Africa and elsewhere. A laboratory study released on Wednesday suggested that the South African virus variant may reduce protective antibodies elicited by the Pfizer/BioNTech vaccine by two-thirds, but it is not clear how much that reduces the shot's effectiveness against this version of the pathogen. Phil Dormitzer, one of Pfizer's top viral vaccine scientists and a co-author of the study, said in an interview he believes the current vaccine is highly likely to still protect against the concerning variant first discovered in South Africa. "A level of neutralizing antibodies that may be on the order of between a third and a half the level of neutralizing antibodies you see against the original virus does not mean you have only a third to half of the protection level, you may well have full protection," he said.
18th Feb 2021 - The Jerusalem Post

Pfizer says South African coronavirus variant could reduce efficacy of vaccine by two-thirds

The South African coronavirus variant may reduce protection from the Pfizer vaccine by two-thirds, according to a new laboratory study from Pfizer and BioNTech. Though it is not clear if the shot is effective against the mutation, the study did find the vaccine is still able to neutralise the virus – and there isn’t real-world evidence from human trials yet that the vaccine is ineffective against the variant. But the companies are still making investments and talking to regulators about developing an updated version of their mRNA vaccine or a booster shot, if needed.
18th Feb 2021 - Metro

Zambia study casts doubt on the assumption that COVID-19 skipped Africa

Covid: Johnson & Johnson's vaccine may actually be TWO doses

Johnson & Johnson's one-dose COVID-19 vaccine was hailed as a way to increase supply and more quickly vaccinate the U.S. population But on Thursday, Andy Slavitt, the White House senior advisor on COVID-19 response, said the company is testing the effectiveness of its shot with a booster It's unclear whether this will delay the vaccine being approved by the U.S. Food and Drug Administration for emergency use authorization Worldwide, J&J's was 66% effective at preventing COVID-19 illness, including 72% effective in the U.S., but just 57% effective in South Africa
18th Feb 2021 - Daily Mail

Pfizer coronavirus vaccine may be less likely to protect against South African variant

The Pfizer vaccine may be less likely to protect against infection from the South African variant than other strains, a laboratory study has found, although experts believe that it should still stop severe illness. Blood taken from people who received the vaccine produced two thirds fewer neutralising antibodies against a virus with the key South African mutations compared with the previous variant.
18th Feb 2021 - The Times

These Doctors Want to Pick Their Covid-19 Vaccine, Fearing Reactions, Lower Efficacy

Health-worker unions in Europe say thousands of their members refuse to take one of the three Covid-19 vaccines available in the region because of concerns over efficacy and reports of side effects, the latest setback for the continent’s slow vaccine rollout. Organizations representing health professionals across Europe said this week that doctors and nurses shouldn’t be forced to take the vaccine developed by AstraZeneca PLC because it was shown to offer less robust protection against Covid-19 than the other two currently authorized in the European Union. They also expressed concern over reports that the AstraZeneca vaccine appeared to cause stronger reactions in recipients.
18th Feb 2021 - Wall Street Journal

Covid: Ethnicity vaccine gaps in over-70s

Black and mixed heritage people in their 70s are being vaccinated against Covid-19 at much lower rates than white people, GP records suggest. And fewer Bangladeshi and Pakistani people had been jabbed by 11 February. This follows data from earlier in the vaccination programme showing similar gaps among the over-80s. A discrepancy was not seen in the over-70s at that point, but this is most likely because very few were being vaccinated at that stage. The findings come from a study called OpenSafely, run by the University of Oxford and the London School of Hygiene and Tropical Medicine. The team has access to completely anonymised medical records covering 40% of GP practices in England.
18th Feb 2021 - BBC News

More than half of South Africans infected by Covid-19, says insurer

More than half the population of South Africa may have been infected by Covid-19, the head of the country’s largest health insurer has said. The nation of 58 million people has been hit by a huge second wave of infections after a new and more contagious variant raced through the population. South Africa has recorded nearly half of the Covid-19 deaths and a third of cases in Africa, although rates of testing are limited in many countries.
18th Feb 2021 - The Times

Delayed Second Dose versus Standard Regimen for Covid-19 Vaccination

Case Vignette - You chair the Governor’s task force on rollout of the Covid-19 vaccine. Given concerns about the limited availability of the two-dose mRNA vaccine, you have been asked to weigh in on the debate regarding the most effective use of the currently available doses. Should people who have already received a first dose of vaccine have their second dose delayed by a number of months until there is a greater supply, so that more people can receive a first dose? Or should those who have gotten the first dose receive the second dose according to the standard schedule, 3 to 4 weeks after the first dose, as recommended by the Food and Drug Administration (FDA)? You must consider the benefits and risks of the two approaches, on both individual and population levels, and decide what to recommend to the task force.
18th Feb 2021 - nejm.org

How have COVID-19 pandemic school closures impacted the health of children globally?

As the current coronavirus disease 2019 (COVID-19) continues to challenge public health, most recently by the emergence of new variants of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), schools in many regions of the world continue to be largely closed. It has been estimated that from March to May 2020, this affected up to 1.5 billion children and young people (CYP). A new study by researchers in the US and the UK explores the damage caused by school closures to educational progress, health, and well-being in CYP globally. Surprisingly, the damage appears to be far less than was originally thought. The team has released their findings on the medRxiv* preprint server.
18th Feb 2021 - News-Medical.Net

Associations between feelings/behaviors during COVID-19 pandemic lockdown and depression/anxiety after lockdown in a sample of Chinese children and adolescents.

Children and adolescents may be more susceptible to mental disorders due to COVID-19 pandemic than adults. This study aimed to identify correlated factors for depression/anxiety among children and adolescents after COVID-19 pandemic lockdown. An online survey by cluster sampling was conducted after lockdown in 5175 Chinese children and adolescents with informed consents from their parents. The 9-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder scales with 10-point cutoff were used to measure depression and anxiety, separately. Stepwise logistic regression was conducted. Stata 15.1 Version was used.
18th Feb 2021 - Physician's Weekly

English lockdown reducing COVID-19 infections but prevalence still high, study finds

England’s third national COVID-19 lockdown is helping to reduce infections, a study found on Thursday, but the prevalence of cases remains high as Prime Minister Boris Johnson eyes a cautious route to re-opening the economy. Johnson is due to set out a roadmap out of the lockdown, which began on January 5, on Monday, and has said that it will be a cautious and prudent approach. The study, known as REACT-1 and led by researchers at Imperial College London, found that national prevalence was two thirds lower between Feb 4 and 13 than it had been in the previous survey that covered Jan 6-22.
18th Feb 2021 - Reuters

Thai-developed COVID vaccine to proceed to human trials

Thailand’s second domestically developed vaccine will soon undergo human trials, officials say, adding that the plan was to produce up to five million doses by the end of the year. The vaccine, developed by Thailand’s Chulalongkorn University, had been successful in trials on mice and monkeys and is due to be tested on humans in late April or early May, Kiat Ruxrungtham of the Chula Vaccine Research Center said on Thursday. “By year-end, we should have a production capacity of one to five million doses annually,” Kiat told a news conference, adding this could later rise to about 20 million doses per year. The announcement comes amid criticism that Thailand’s vaccine strategy has been slow and overly reliant on AstraZeneca shots being produced by local manufacturer Siam Bioscience, which owned by the country’s king. The Thai-developed “ChulaCov19” vaccines are initially being produced in California, but will be produced locally in later stages by Thai company Bionet Asia, Kiat said.
18th Feb 2021 - AlJazeera

Pfizer, Moderna vaccines may be less effective against B1351 variant

Both the Pfizer/BioNTech and the Moderna COVID-19 vaccines may be less effective against the B1351 variant first identified in South Africa, although the latter vaccine could offer good protection against the B117 variant first seen in the United Kingdom, according to two letters published yesterday in the New England Journal of Medicine. In the letter on the Pfizer/BioNTech BNT162b2 coronavirus vaccine, a team led by scientists from the University of Texas Medical Branch in Galveston made three recombinant viruses with different mutations using a SARS-CoV-2 isolate from January 2020. Using 20 serum samples collected from 15 participants in a 2020 trial of the vaccine 2 to 4 weeks after their second dose, they tested the samples' ability to neutralize the 2020 strain and all variants, including B1351 and B117.
18th Feb 2021 - CIDRAP

Vitamin D not effective in moderate to severe COVID, study finds

Less than a week after JAMA Network Open published a small study showing zinc and vitamin C were not associated with improved mild COVID-19 infections, a 240-person JAMA study also found that a single dose of vitamin D did not have any significant effect on moderate to severe COVID-19 infections. The study, published yesterday by Igor Murai, PhD, a Sao Paul rheumatologist, and colleagues, reported that hospital stay was a median 7.0 days for both those in the intervention and the placebo group, and while there were differences up to 8.4 percentage points across in-hospital mortality, intensive care unit (ICU) admission, and mechanical ventilation needs, they were all statistically not significant.
18th Feb 2021 - CIDRAP

UK COVID-19 swab study highlights lockdown impact

The latest results from an ongoing study from Imperial College London to track COVID-19 patterns in Britain show that infections have fallen by more than two-thirds since January, likely due to lockdowns. In other global developments, the World Health Organization announced a new battle plan against COVID-19. The research team based at Imperial College London, part of the REACT program, has been using home-based swab tests to tracking virus spread, and their latest results from a preprint study include 85,000 people who were tested between Feb 4 and Feb 13. Infections fell across the country, with steeper drops in London and the South East, and more modest declines in Yorkshire and Humber. Prevalence dipped across all ages at a similar level, suggesting that the pattern is due to the lockdown, rather than vaccination. However, they warned that infections are still high, at about 1 in 200 people, with the highest levels seen in young people ages 5 to 12 and those ages 18 to 24 years old.
18th Feb 2021 - CIDRAP

Novavax, coronavirus shot data in hand, strikes an eye-popping supply deal with global vaccine consortium

COVID-19 vaccine maker Novavax has at times flown under the radar as some of the world's leading drugmakers dominated headlines and raced toward rollouts. But an eye-popping new supply deal with international players is sure to turn heads. Novavax on Thursday unveiled a memorandum of understanding with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of its coronavirus vaccine candidate to COVAX, a global effort to ensure equitable vaccine distribution. The Serum Institute of India will help produce doses under a prior deal between that company and Gavi. The deal will support work by Gavi, the Coalition for Epidemic Preparedness Innovations and the World Health Organization to distribute doses in every country worldwide.
18th Feb 2021 - Fierce Pharma

Bring on the boosters: Studies show Pfizer, Moderna COVID vaccines are less potent against aggressive variant

In early January, researchers from the University of Texas and Pfizer published a preprint study suggesting that Pfizer’s COVID-19 vaccine could protect against a mutation discovered in the U.K. and South Africa. Two weeks later, though, news emerged that Pfizer and its partner BioNTech were working on booster shots to protect against new variants. Now there’s more evidence that Pfizer’s vaccine—as well as the other authorized mRNA vaccine from Moderna—will need to be updated to fend off aggressive new variants of COVID-19. The data are raising concerns among some analysts of "breakthrough" cases of COVID-19, even in vaccinated people, and the potential for more lockdowns this summer. In a letter published in the New England Journal of Medicine Wednesday, Pfizer and the University of Texas said a lab study showed the vaccine was about two-thirds less potent against the South African variant of COVID-19 than it was against the original virus.
18th Feb 2021 - Fierce Pharma

Pfizer study another worry for South Africa's vaccine rollout

Scientists will meet on Thursday to advise South Africa’s government on its next steps after a study suggested the dominant local coronavirus variant may reduce protective antibodies from Pfizer’s COVID-19 vaccine by two-thirds. The laboratory study, published in the New England Journal of Medicine, is another worry for the country hardest-hit by the pandemic on the African continent after it placed AstraZeneca vaccinations on hold earlier this month. Although its implications on the real-world efficacy of Pfizer’s vaccine are not yet clear, the study comes after clinical trial data on the AstraZeneca, Johnson & Johnson (J&J) and Novavax vaccines showed reduced efficacy against the more contagious 501Y.V2 variant, first identified late last year.
18th Feb 2021 - Reuters

How covid-19 testing is developing and its future

An HSJ and Siemens Healthineers roundtable discussed how the covid-19 testing regime has developed to date, how it will need to evolve further to consistently reach the right person with the right test at the right time, and what its likely legacy will be for the diagnostics sphere as a whole. The words “testing” and “game changer” have frequently been seen together in the months since the pandemic began. Boris Johnson initially applied the phrase to antibody testing and then in September to rapid mass testing of asymptomatic individuals, which he suggested could offer a route to renewed social gatherings even pre-widespread vaccination. But away from such high profile proclamations, how has covid-19 testing actually developed? And how could and should it develop in the longer term?
17th Feb 2021 - Health Service Journal

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Feb 2021

View this newsletter in full

Pfizer says South African variant could significantly reduce vaccine protection

A laboratory study suggests that the South African variant of the coronavirus may reduce antibody protection from the Pfizer Inc/BioNTech SE vaccine by two-thirds, and it is not clear if the shot will be effective against the mutation, the companies said on Wednesday.
18th Feb 2021 - Reuters

Senate panel endorses bill seeking P500M indemnification fund for COVID-19 vaccine side effects

The Senate Finance Committee has endorsed for plenary approval a measure that would ensure availability of national funds to compensate Filipinos in case they die or experience serious side effects after receiving COVID-19 shots. Senator Sonny Angara, who serves as the chair of the panel, sponsored Bill No. 2057 or the proposed COVID-19 Vaccination Program Act of 2021 on Tuesday. It consolidated the bills related to COVID-19 vaccines filed by other lawmakers. Under the bill, ₱500 million will be provided for the COVID-19 National Indemnity Fund. The money will be sourced from the contingent fund of the national budget. State insurance agency PhilHealth was tasked to oversee its administration. A special task group composed of medical and vaccine experts will conduct post-vaccination monitoring of patients.
17th Feb 2021 - CNN Philippines

Study Investigates COVID-19 in Pregnant Patients with Rheumatologic Disease

A new study has found that among patients with rheumatologic disease, pregnancy is not associated with increased self-reported COVID-19, but is associated with a shorter duration of COVID-19 symptoms and a higher prevalence of loss of smell or taste. The study, by researchers from Hospital for Special Surgery (HSS), in New York City, appears online first in the journal Arthritis Care & Research.
17th Feb 2021 - Associated Press

Experts say India's Covid-19 'human barricade' to keep cases under control

With falling rates of Covid-19 infection in India and surveys suggesting nearly 300 million people may already have antibodies, some experts believe the worst of the disease has passed, despite a recent uptick in two hard-hit states. "There is a human barricade for the virus," said Bhramar Mukherjee, an epidemiologist at the University of Michigan, who with a team of researchers, has been modeling the trajectory of the outbreak in India. "By the end of March, we should see a very slow, steady decline (in cases)," she added. Cases that were rising by nearly 100,000 a day in September are now growing at just 10,000 a day. And India's official number of total infections, which was projected to surpass that of the United States in late 2020, now stands at 11 million, well behind the US tally of about 28 million.
17th Feb 2021 - Hindustan Times

‘India’s COVID-19 infections grossly underestimated’

India’s southern state of Karnataka alone may have had 31.5 million cases of COVID-19 or nearly 95 times greater than have been reported, says a new study that puts a question mark on the 10 million plus cases reported for the whole country so far. Published this month in the Journal of the American Medical Association, the study is based on data collected from a representative sample of households in 20 districts of Karnataka, home to 70 million of India’s 1.3 billion people. As of Monday, 15 February, according to Worldometers, India had recorded 10,916,589 cases of COVID-19, second only to the US with 28,261,470 cases. Brazil came in third with 9,834,513 cases.
17th Feb 2021 - SciDev

Lockdown may have boosted well-being for some

A study of people who care for children finds that COVID-19 lockdowns have provided some unexpected benefits. Survey respondents report four areas of personal growth that have been given an opportunity to flourish when busy lives were interrupted. People reported positive changes in their family relationships, spiritual well-being, and more. The study suggests ways we may emerge from the pandemic strengthened by the experience.
17th Feb 2021 - Medical News Today

Covid-19: World's first human trials given green light in UK

Healthy, young volunteers will be infected with coronavirus to test vaccines and treatments in the world's first Covid-19 "human challenge" study, which will take place in the UK. The study, which has received ethics approval, will start in the next few weeks and recruit 90 people aged 18-30. They will be exposed to the virus in a safe and controlled environment while medics monitor their health. The UK has given doses of a Covid vaccine to more than 15 million people. Human challenge studies have played a vital role in pushing the development of treatments for a number of diseases, including malaria, typhoid, cholera and flu.
17th Feb 2021 - BBC News

‘NHS workers will need help to manage the trauma of the pandemic’

There’s no doubt some occupational groups have had a particularly tough time, especially NHS workers. Many NHS staff have dealt with inordinate numbers of critically ill patients. Some have been trying to provide care in a far from ideal situation, knowing that doing so will lead to poor outcomes for their patients. This is having an impact on their mental health. My recent study of staff working in critical care during the pandemic showed they report more than twice the rate of probable post-traumatic stress disorder (PTSD) found in military veterans who’ve recently experienced combat. While the situations may be different, there might be some lessons we can learn from studied of PTSD in military veterans to help NHS workers cope during the pandemic.
17th Feb 2021 - Nursing Notes

Contact tracing alone has little impact on curbing Covid spread, report finds

Contact tracing alone has a marginal impact on Covid transmission, curbing the spread of the disease by just 2% to 5%, official estimates show. The figures come after Dido Harding, who heads the government’s £22bn test-and-trace programme in England, suggested it was set to substantially reduce the spread of coronavirus this spring. Newly published data behind that assertion shows the vast majority of the impact of test and trace is down to people self-isolating. An army of contact tracers has been hired to track down close contacts of those who test positive for Covid, and ask them to self-isolate. The contact tracers also remind people of the need to quarantine after a positive test.
17th Feb 2021 - The Guardian

Pregnancy tied to estimated 70% higher COVID-19 rate

Pregnant women in Washington state were infected with COVID-19 at a 70% higher rate than others of similar ages, with nonwhite women shouldering a disproportionate burden, according to a study published yesterday in the American Journal of Obstetrics & Gynecology. Noting that population-based estimates of coronavirus infections in pregnancy are unreliable due to incomplete recording of pregnancy status or inclusion of only hospitalized patients, a team led by researchers from the University of Washington in Seattle analyzed data from 240 pregnant COVID-19 patients at 35 healthcare systems, capturing 61% of the state's annual births, from Mar 1 to Jun 30, 2020.
17th Feb 2021 - CIDRAP

FDA could reject AstraZeneca’s COVID vaccine on efficacy and manufacturing shortfalls: analyst

It was bad enough when a study released last week concluded that AstraZeneca’s COVID-19 vaccine was largely ineffective against the aggressive B.1.351 variant that recently emerged in South Africa. Now, analysts are wondering whether inconsistent manufacturing of the vaccine for the clinical trials may have muddied the results—concerns that could give the FDA pause when considering the vaccine for emergency use. That was the conclusion of a note SVB Leerink analysts sent to clients Wednesday, in which they laid out both the bear and bull cases for FDA authorization of AstraZeneca’s COVID vaccine. The bottom line? The bear case is worrisome, they said. One major concern SVB Leerink cited is that AstraZeneca is manufacturing its vaccine on a “distributed” basis, meaning it’s not centralized, but spread over multiple sites and contract partners. The material used to make the vaccine for the South Africa trial came from a company in India, and it’s not clear where it was manufactured or whether the results from that trial truly reflect the properties of the vaccine that’s being developed for the U.S.
17th Feb 2021 - FiercePharma

Pfizer, Moderna pledge more mRNA vaccine doses to Europe after AZ supply concerns

After a coronavirus vaccine supply feud between top officials in Europe and COVID-19 vaccine player AstraZeneca, officials there are doubling down on their purchase of an alternative technology. This week, the bloc finalized the purchase of 350 million additional mRNA vaccine doses. Pfizer and BioNTech struck a deal with the European Commission to supply 200 million more doses of their mRNA-based COVID-19 vaccine, Corminaty, to the European Union, with the option to sell an additional 100 million doses at a later date. The move comes after a factory upgrade in Belgium prompted the companies to temporarily reduce shipments with an eye on delivering "significantly more" doses in the second quarter. The sale comes on top of 300 million Comirnaty doses the partners sold to the EU in November, bringing the bloc's total order up to 500 million shots. The new 200-million-dose tranche will be rolled out in 2021, with some 75 million doses pegged for delivery in the second quarter.
17th Feb 2021 - Scientific Viewpoint

In lab experiment, Pfizer-BioNTech vaccine less potent against coronavirus variant

The Pfizer-BioNTech Covid-19 vaccine loses some potency against the coronavirus variant that first appeared in South Africa, researchers reported Wednesday, based on lab experiments. What the findings mean for how well the vaccine will protect real people from the variant, called B.1.351, is hard to tell. But clinical data from three other vaccines — those from AstraZeneca, Novavax, and Johnson & Johnson — have already shown the shots are not as powerful at blocking symptomatic Covid-19 cases caused by B.1.351 as by other forms of the virus. In the new study, which was published Wednesday in the New England Journal of Medicine, researchers from Pfizer, BioNTech, and the University of Texas Medical Branch examined how well blood taken from people who had received the companies’ shot fought off a virus engineered to have the key mutations found in B.1.351. They reported that there was about a two-thirds drop in neutralization power against the variant compared to other forms of the SARS-CoV-2 coronavirus.
17th Feb 2021 - STAT News

The myth of ‘good’ and ‘bad’ Covid vaccines: Why false perceptions overlook facts, and could breed resentment

Mike Ryan, the World Health Organization’s health emergencies director, had a conversation recently with his mother, the kind that lots of public health people are having these days, much to their dismay. Ryan’s mother was concerned about one of the Covid-19 vaccines in use in Ireland, where she lives. The one made by AstraZeneca. Clinical trials had shown the vaccine offered protection against the disease, but less than the vaccine made by Moderna or the one made by Pfizer and BioNTech. Ryan’s mother was worried the vaccine might not be good enough.
17th Feb 2021 - STAT News

Lab studies suggest Pfizer, Moderna vaccines can protect against coronavirus variant

A new report published in the New England Journal of Medicine on Wednesday suggests that Pfizer-BioNTech's Covid-19 vaccine can protect people against concerning new coronavirus variants, including one first seen in South Africa called B.1.351. For the study, researchers at Pfizer and the University of Texas Medical Branch genetically engineered versions of the virus to carry some of the mutations found in B.1.351. They tested them against blood samples taken from 15 people who had received two doses of the Pfizer/BioNTech vaccine as part of a clinical trial. While the blood serum samples produced less neutralizing antibody activity, it was still enough to neutralize the virus, they wrote in a letter to the journal. This is in line with other studies. And it's well within what is seen with other viruses, one of the researchers said.
17th Feb 2021 - CNN

South Africa launches vaccine roll-out with Johnson & Johnson jab

South Africa has kicked off its vaccination campaign against COVID-19 by injecting healthcare workers with the shot developed by Johnson & Johnson as part of an observational study. The first healthcare worker was inoculated at 1pm (11:00 GMT) on Wednesday at the Khayelitsha District Hospital in Cape Town, following the arrival of 80,000 vaccine doses at Johannesburg’s international airport the night before. President Cyril Ramaphosa, along with Health Minister Zweli Mkhize and Deputy Health Minister Joe Phaahla, were also among the first to be vaccinated. “This day marks a milestone for South Africa. Finally, the vaccines are here, and they are being administered,” Ramaphosa told reporters as he sought to allay any fears among South Africans sceptical about an inoculation drive that has been hit by delays and the spread of misinformation. “I’d like to invite South Africans to take this up so that we can all be safe and we can all be healthy.”
17th Feb 2021 - Al Jazeera English

Exclusive: Two variants have merged into heavily mutated coronavirus

Two variants of the SARS-CoV-2 coronavirus that causes covid-19 have combined their genomes to form a heavily mutated hybrid version of the virus. The “recombination” event was discovered in a virus sample in California, provoking warnings that we may be poised to enter a new phase of the pandemic. The hybrid virus is the result of recombination of the highly transmissible B.1.1.7 variant discovered in the UK and the B.1.429 variant that originated in California and which may be responsible for a recent wave of cases in Los Angeles because it carries a mutation making it resistant to some antibodies. The recombinant was discovered by Bette Korber at the Los Alamos National Laboratory in New Mexico, who told a meeting organised by the New York Academy of Sciences on 2 February that she had seen “pretty clear” evidence of it in her database of US viral genomes.
16th Feb 2021 - New Scientist

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Feb 2021

View this newsletter in full

Call for nurses to join Covid-19 vaccine side effects study

Nurses and other health professionals from the UK are being encouraged to take part in a safety study of the Oxford/AstraZeneca Covid-19 vaccine in order to tackle possible side effects. They are also being asked to urge patients to sign up to the study,
16th Feb 2021 - Nursing Times

Bristol children as young as six can take part in Oxford University coronavirus vaccine trial

Bristol has been selected as one of four locations to take part in a world-first coronavirus vaccine trial for children. The University of Oxford study will recruit up to 300 child volunteers nationally, aged between six and 17 years old, to investigate if the current Oxford-AstraZeneca vaccine is effective in protecting children. As well as the Oxford site, three partner sites in London, Southampton and at Bristol Royal Hospital for Children will run the trial. It launched today (Monday, February 15) and the first vaccinations are expected to commence later this month. Recruitment for Bristol's is open to all BS postcodes via the trial website, which states that participants from Black, Asian and minority ethnic groups are "particularly welcome" to take part. The length of the study is one year and participants will be asked to attend five visits, with anyone under the age of 16 requiring parental consent.
16th Feb 2021 - Bristol Live

My Teens Are Coronavirus Vaccine Guinea Pigs

The day after my teenagers got their first shots in the Moderna Covid vaccine trial, I found my 13-year-old daughter, Zoe, sprawled out in bed during a distance-learning art class. Under a pile of blankets, she said she had chills. My heart skipped a beat. Any other time I would have worried about her missing school or Nordic ski practice, but this time I was elated when her temperature peaked at 100.5 degrees. A fever meant she was probably reacting to a real mRNA vaccine, and not a placebo. Maybe she’d won the vaccine lottery! When Pfizer and Moderna were granted emergency authorization to license their vaccines in December, the shots were approved for people as young as 16 and 18, respectively. But in order to end the pandemic, many experts said that younger children will need to be vaccinated.
16th Feb 2021 - The New York Times

North Korean hackers attempted to steal Pfizer coronavirus vaccine

South Korea's National Intelligence Service claim North Korea tried stealing data The NIS claim hackers targeted vaccine manufacturer Pfizer to steal information North Korea has continuously claimed it has not had a single Covid-19 case Last month it was reported North Korea was starting to develop its own vaccine
16th Feb 2021 - Daily Mail

Covid vaccine impact revealed in over-80s blood tests

England's vaccination programme is starting to pay off, with the over-80s age group now the most likely to test positive for coronavirus antibodies, Office for National Statistics testing suggests. Blood tests reveal more over-80s than any other age group in England are showing signs of some immunity against Covid infection. This comes as Covid deaths have fallen. But overall, deaths are still 40% above the five-year average.
16th Feb 2021 - BBC News

Why the three biggest vaccine makers failed on Covid-19

As pharmaceutical companies raced to develop Covid-19 vaccines, crossing the finishing line in record time, the world’s three biggest vaccine makers were also-rans. GlaxoSmithKline, Merck and Sanofi are now left playing catch-up, after upstarts including Moderna and BioNTech demonstrated their mastery of new technologies that will shape the industry for years to come. New Jersey-based Merck recently dropped its vaccine development programme completely, while Paris-based Sanofi and the UK’s GSK are having to redo an early-stage trial of the jab they are jointly developing, after a dosing mistake.
16th Feb 2021 - The Financial Times

Covid-19 could cause potentially dangerous 'nodules' on patients' EYEBALLS due to inflammation triggered by the virus, scientists warn

From a dry cough to a high fever, coronavirus is known to be linked to a range of unpleasant symptoms. Now, a new study has revealed another potential side effect - nodules on the eyeballs. Researchers have warned that coronavirus infection may trigger inflammation of the eyeballs and lead to the formation of mysterious nodules at the back of the organ. Experts do not yet know what causes these nodules or the impact they have on a patient's long-term health. However, a study of 129 French patients who had severe Covid-19 and underwent MRI scans revealed nine of them (seven per cent) suffered abnormalities.
16th Feb 2021 - Daily Mail on MSN.com

GPs could offer common asthma drug as early Covid-19 intervention

A common asthma drug, Budesonide, which could be given by GP surgeries as an early community intervention, has been found to reduce Covid-19 symptoms. In a small trial at the University of Oxford, the steroid inhaler was given seven days after the onset of Covid-19 symptoms and appeared to significantly reduce the need for critical care. The researchers also reported persistent symptoms, seen after 28 days, were reduced with the asthma drug. The study, which has yet to be peer-reviewed, involved 146 people who had tested positive for Covid-19, half of whom were given 800 mg of Budesonide twice a day and the other half received the usual care.
16th Feb 2021 - Pulse Today

SA asks Serum Institute to take back 1 million vaccine doses — report

SA has asked the Serum Institute of India to take back the one million Covid-19 vaccine doses the company had sent in early February, The Economic Times reported on Tuesday, a week after the country said it will put on hold use of AstraZeneca's shot in its vaccination programme. Serum Institute of India, which is producing AstraZeneca's shot, has emerged as a key vaccine supplier. One million doses of the Covid-19 vaccine landed in SA last week and another 500,000 were due to arrive in the next few weeks. The company did not immediately respond to a Reuters request for comment.
16th Feb 2021 - TimesLIVE

Novavax signs deal with SK Bioscience for 40 mln vaccine doses for S. Korea

U.S. drug developer Novavax Inc said on Monday it has signed a license agreement with South Korea manufacturer SK Bioscience to produce 40 million doses of its COVID-19 vaccine for South Korea. “Concurrently, SK Bioscience has finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021,” Novavax said in a statement https://bit.ly/37eMKB2.
16th Feb 2021 - Financial Post

WHO authorizes AstraZeneca's COVID vaccine for emergency use

The World Health Organization has granted an emergency authorization to AstraZeneca’s coronavirus vaccine, a move that should allow the U.N. agency’s partners to ship millions of doses to countries as part of a U.N.-backed program to tame the pandemic. In a statement Monday, the WHO said it was clearing the AstraZeneca vaccines made by the Serum Institute of India and South Korea’s AstraZeneca-SKBio. The WHO’s green light for the AstraZeneca vaccine is only the second one the U.N. health agency has issued after authorizing the Pfizer-BioNTech vaccine in December. Monday’s announcement should trigger the delivery of hundreds of millions of doses to countries that have signed up for the U.N.-backed COVAX effort, which aims to deliver vaccines to the world’s most vulnerable people.
16th Feb 2021 - Associated Press

Another new coronavirus variant seen in the UK

Scientists have identified another new variant of coronavirus in the UK with some potentially troubling mutations. B.1.525 appears similar to the South African variant which prompted door-to-door tests in areas where it has been found. Researchers from Edinburgh University have found 38 cases so far - 2 in Wales and 36 in England - in samples dating back to December. It has been seen in other countries, including Denmark, Nigeria and the US. UK experts are studying it to understand what risk it poses. It is too soon to say if it should be added to the UK's list of "variants of concern" and whether mass testing for it should happen. So, for now, it is a "variant under investigation".
16th Feb 2021 - BBC News

Brazil says Amazon COVID-19 variant three times more contagious

A coronavirus variant identified in the Brazilian Amazon may be three times more contagious but early analysis suggests vaccines are still effective against it, the country’s health minister said on Thursday, without providing evidence for the claims. Under pressure as the variant hammers the jungle city of Manaus with a devastating second wave of infections, Health Minister Eduardo Pazuello sought to reassure legislators that the surge of recent months was unexpected but coming under control.
12th Feb 2021 - Al Jazeera English

COVID-19: Scientists identify new coronavirus variant with potentially concerning mutations

Scientists have identified another new coronavirus variant in the UK which has potentially concerning mutations. B.1.525, the new variant, contains a genetic change called E484K which is also found in the Brazilian and South African variants. Public Health England (PHE) has said there is no evidence that the mutations in the new variant make the virus more transmissible or cause severe disease. Laboratory studies have shown that viruses with the E484K mutation can escape human defences, making them more efficient at evading natural and vaccine-triggered immunity
16th Feb 2021 - BBC News

Fauci wins $1 million Israeli prize for 'defending science'

The Dan David Foundation, which is based at Tel Aviv University, said on Monday that Fauci has won the prize for “courageously defending science in the face of uninformed opposition during the challenging COVID crisis,” the Seattle Times reported. “As the COVID-19 pandemic unraveled, [Fauci] leveraged his considerable communication skills to address people gripped by fear and anxiety and worked relentlessly to inform individuals in the United States and elsewhere about the public health measures essential for containing the pandemic’s spread,” the foundation’s awards committee said.
16th Feb 2021 - The Hill

Initial sky-high UK in-hospital COVID death rate fell sharply

The in-hospital death rate among adult COVID-19 patients in England early in the pandemic was 31% but declined significantly over time, with older age, male sex, low socioeconomic status, Asian or mixed ethnicity, and underlying conditions signaling poor outcomes, according to a retrospective, observational study published yesterday in The Lancet Respiratory Medicine. A team led by a researcher from University College London used the National Health Service Hospital Episode Statistics administrative dataset to estimate in-hospital deaths and contributing factors among 91,541 COVID-19 patients at 500 hospitals from Mar 1 to May 31, 2020.
16th Feb 2021 - CIDRAP

U.K. inspects AstraZeneca vaccine partner's India manufacturing, setting stage for supply boost

AstraZeneca set up a globetrotting supply network for its COVID-19 vaccine to deliver doses around the world, but it hasn't tapped regional producers to ease delivery shortfalls elsewhere. But that could change—and soon. British regulators are inspecting one of the drugmaker's biggest production partners, Serum Institute of India, which signed on to manufacture AstraZeneca's shot for its home country and other global markets. Sources close to the matter told Reuters about the manufacturing audit. A green light from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) could clear the way for AstraZeneca to import the India-made shots to the U.K. and EU, which has struggled to beef up vaccine supplies after AZ said it would cut first-quarter deliveries last month.
16th Feb 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Feb 2021

View this newsletter in full

Next coronavirus vaccines may be drops, pills or printed on demand

The race to develop vaccines against covid-19 got off to a flyer, but with dangerous new virus variants, stark inequalities in access to vaccines and few vaccination options for children, the world still needs all hands on deck. Last week, a virtual meeting run by the New York Academy of Sciences called The Quest for a COVID-19 Vaccine showcased the most promising new candidates. So far, all approved covid-19 vaccines have been injectable. Another option is a nose drop, says Robert Coleman, CEO of biotech company Codagenix, in Farmingdale, New York.
15th Feb 2021 - New Scientist

Countries already using Pfizer coronavirus vaccine include UK, US, Canada and Singapore

As Australia takes delivery of its first shipment of coronavirus vaccines, at least 44 countries have already begun inoculating their citizens using the Pfizer-BioNTech shot, World Health Organization data shows. Dozens of other countries have also begun mass inoculations, but they have started early without WHO approval. The Pfizer shot is the only vaccine with WHO emergency approval so far. The countries using the vaccine are mostly located in Europe, with Canada, the United States, Chile, Singapore and some Middle Eastern countries also securing doses.
15th Feb 2021 - ABC News

Pan-European consortium seeks big pharma partner for COVID-19 shot

A pan-European consortium developing a COVID-19 vaccine is in talks with big pharma to support the late-stage development of its shot and ramp up manufacturing, the head of German biotech firm Leukocare told Reuters. Leukocare is working with Italy’s ReiThera and Belgium’s Univercells on a vaccine based on a so-called non-replicating adenoviral vector, the same technology that AstraZeneca and Johnson & Johnson have used. Chief Executive Michael Scholl said the companies were talking to potential big pharma partners about whether they could provide additional manufacturing capacity, as well as help to advance their candidate through Phase III clinical trials.
15th Feb 2021 - Reuters

Wearing a face mask can reduce your risk of severe Covid-19: Humidity inside coverings limits the spread of the virus to the lungs leading to milder infection, study shows

NIH researchers assessed humidity of a space before and after wearing a mask. Masks increase humidity by between 38 and 90 per cent compared to maskless. This leads to hydrated air being inhaled by the person wearing the mask. This helps the respiratory tract to clear out the virus in the mucus and prevent it reaching the lungs
15th Feb 2021 - Daily Mail

COVID-19 shots might be tweaked if variants get worse

The makers of COVID-19 vaccines are figuring out how to tweak their recipes against worrisome virus mutations — and regulators are looking to flu as a blueprint if and when the shots need an update. “It’s not really something you can sort of flip a switch, do overnight,” cautioned Richard Webby, who directs a World Health Organization flu center from St. Jude Children’s Research Hospital. Viruses mutate constantly and it takes just the right combination of particular mutations to escape vaccination. But studies are raising concern that first-generation COVID-19 vaccines don’t work as well against a mutant that first emerged in South Africa as they do against other versions circulating around the world.
15th Feb 2021 - The Independent

Covid-19: Vaccine as good in 'real world' as in trial in Israel

More data from Israel's vaccination programme is suggesting the Pfizer jab prevents 94% of symptomatic infections. This indicates the vaccine is performing just as well in a larger population as it did in the clinical trials. It is proving highly effective at preventing illness and severe disease among all age groups, according to public health doctor Prof Hagai Levine. "High vaccination coverage of the most susceptible groups" was key, he said. Israel's largest health fund Clalit looked at positive tests in 600,000 vaccinated people and the same number of unvaccinated people, matched by age and health status. It found 94% fewer infections among the vaccinated group. This was based on test results in people's medical records, usually taken if they had symptoms or were a close contact of someone who had tested positive. And the vaccine prevented almost all cases of serious illness. This pattern was the same in all age groups - including the over-70s, who may have been under-represented in clinical trials.
15th Feb 2021 - BBC News

The search for new Covid drugs — and a researcher’s reason for optimism

David Fajgenbaum is a physician and scientist at the University of Pennsylvania. He is best known for his personal battle against Castleman Disease, which nearly killed him before he discovered a treatment that saved his life. Now, however, Fajgenbaum’s research lab at Penn is now working to catalog and analyze drugs that might prove effective against Covid-19. He recently joined STAT’s podcast, “The Readout LOUD,” to discuss that work and more. Excerpts of the conversation are below, lightly edited for clarity.
15th Feb 2021 - Stat News

WHO approves AstraZeneca/Oxford COVID-19 vaccine for emergency use

The World Health Organization (WHO) on Monday listed AstraZeneca and Oxford University’s COVID-19 vaccine for emergency use, widening access to the relatively inexpensive shot in the developing world. “We now have all the pieces in place for the rapid distribution of vaccines. But we still need to scale up production,” Tedros Adhanom Ghebreyesus, WHO Director-General, told a news briefing. “We continue to call for COVID19 vaccine developers to submit their dossiers to WHO for review at the same time as they submit them to regulators in high-income countries,” he said. A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
15th Feb 2021 - Reuters

How effective is a single vaccine dose against Covid-19?

The cases are already beginning to emerge. When 85-year-old Colin Horseman was admitted to Doncaster Royal Infirmary in late December, it was for a suspected kidney infection. But not long afterwards he caught Covid-19 – at the time, roughly one in four people in hospital with the virus had acquired it there. He developed severe symptoms and was eventually put on a ventilator. A few days later, he died. At first glance, Horseman's situation may seem fairly typical, though no less tragic for it. After all, at least 84,767 people have now succumbed to the disease in the UK alone at the time of writing. But, as his son recently explained in a local newspaper, less than three weeks earlier he had been among the first people in the world to receive the initial dose of a Covid-19 vaccine – the Pfizer-BioNTech version. He was due to receive the second dose two days prior to his death.
15th Feb 2021 - BBC News

Is it safe for pregnant women to have a COVID-19 vaccine?

Last week, my sister who is an NHS dentist, told me she was going to get her first dose of the COVID-19 vaccine. While we spoke on the phone, she said she was a little apprehensive about getting it. When I asked her why she said two of the dental nurses at her surgery were not getting theirs as they both saw messages on WhatsApp that said the vaccine would make them infertile. I told my sister it was complete nonsense and that there was no evidence to suggest this was true; she subsequently went to get vaccinated, but the nurses did not. Sadly, I am hearing from many young people who are hesitant to take the COVID vaccine due to misinformation they have come across around fertility – so let me address this issue head-on.
15th Feb 2021 - Al Jazeera English

COVID-19: Oxford vaccine creator calls for donations to help people in poorer countries receive a jab

The co-creator of the Oxford vaccine has called on people to give money to support coronavirus vaccination in poorer countries. Professor Sarah Gilbert is backing a new campaign launching today, which asks people in the UK to give money to the World Health Organisation COVID-19 relief fund when they receive the date for their coronavirus vaccination. "We produced and developed the Oxford vaccine as a vaccine for the world," Professor Gilbert said about the campaign, which is called Arm in Arm. "We are happy to support a new initiative to get COVID vaccines to as many people as possible."
14th Feb 2021 - Sky News

WHO green-lights AstraZeneca COVID vaccine for urgent use

The World Health Organization (WHO) today announced that the AstraZeneca-Oxford COVID-19 vaccine made in two different countries is listed for emergency use, clearing the final hurdle for doses to be distributed by the COVAX program. In other developments, WHO officials said multiple factors are probably responsible for a drop in global cases, and the European Centre for Disease Prevention and Control (ECDC) said in its latest risk assessment that countries are seeing an increase in the number and proportion of SARS-CoV-2 variants.
14th Feb 2021 - CIDRAP

Coronavirus China: WHO scientist says virus was 'widespread' in December

Peter Embarek, lead WHO researcher in Wuhan, has revealed virus was circulating 'widely' in December 2019. He also revealed 13 variants were found among early cases, suggesting disease was in humans for some time. Embarek stopped short of saying disease was circulating before December, but called for further research Comes less than a week after Embarek told a press conference in China that there is no evidence the virus was circulating 'in Wuhan or elsewhere' before December
14th Feb 2021 - Daily Mail

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Feb 2021

View this newsletter in full

Lifelong immunity hope for Covid-19 vaccine

Trials of coronavirus vaccines for children as young as five are set to begin within days, laying the groundwork for a childhood immunisation programme that could protect people from Covid-19 for most of their lives. AstraZeneca started recruiting British children for a paediatric trial, with the first vaccines to be given by the end of the month. Pfizer is close to beginning a similar global trial. If successful they could pave the way for a vaccine programme on the model of measles or polio, in which a series of jabs early in life provide immunity lasting decades. A booster programme might be needed for the elderly. Professor Sarah Gilbert, chief investigator on the Oxford team behind the AstraZeneca vaccine, believes such a programme could reduce the consequence of Covid infection for most healthy adults to those of a cold
14th Feb 2021 - The Times

China hits back after US expresses 'deep concerns' over WHO Covid-19 report

China has fired back at the US over allegations from the White House that Beijing withheld some information about the coronavirus outbreak from World Health Organization investigators. The White House on Saturday called on China to make data from the earliest days of the Covid-19 outbreak available, saying it had “deep concerns” about the way the findings of the WHO’s Covid-19 report were communicated. China responded with a statement from its Washington embassy on Sunday, saying the US had already gravely damaged international cooperation on Covid-19 and was now “pointing fingers at other countries who have been faithfully supporting the WHO and at the WHO itself”.
14th Feb 2021 - The Guardian

Covid-19 may not have started in China, says WHO expert

The virus which causes Covid-19 may not have emerged in China, a World Health Organisation (WHO) scientist has suggested. Professor John Watson, who was part of the WHO team that travelled to China to investigate the origins of the pandemic, said the virus’s leap from animals to humans may have occurred outside the country’s borders. He told BBC One’s The Andrew Marr Show that the pandemic most likely started with an infection in an “animal reservoir” which was then passed on to humans through an “intermediate host”. Asked if he was sure the virus emerged in China, Prof Watson, who previously served as England’s deputy chief medical officer until 2017, said “no”.
14th Feb 2021 - Wales Online

COVID-19: Vaccines giving 67% protection after three weeks, large-scale research shows

One dose of a COVID-19 vaccine gives 67% protection after three weeks, a leading epidemiologist has said. Professor Tim Spector of King's College London, who runs the ZOE COVID-19 surveillance app, said data collected from 50,000 users vaccinated with either the Pfizer or Oxford/AstraZeneca jab showed one dose gave 46% protection after two weeks, rising to 67% after three to six weeks. The app uses information submitted by more than four million users across the world to predict and track coronavirus infections across the UK and other countries
14th Feb 2021 - Sky News

Double masking can block 92% of infectious particles, CDC says

Double masking can significantly improve protection, new data from the US Centers for Disease Control and Prevention shows. Researchers found that layering a cloth mask over a medical procedural mask, such as a disposable blue surgical mask, can block 92.5% of potentially infectious particles from escaping by creating a tighter fit and eliminating leakage. "These experimental data reinforce CDC's prior guidance that everyone 2 years of age or older should wear a mask when in public and around others in the home not living with you," CDC Director Dr. Rochelle Walensky, told a White House briefing.
14th Feb 2021 - CNN

UK’s ‘Professor Lockdown’ hopeful there will be no further lockdowns

Britain's "Professor Lockdown" says the U.K. is on track to start loosening restrictions next month — and that he's optimistic there will be no need for further lockdowns in the year ahead. Professor Neil Ferguson of Imperial College London said the spread of the so-called U.K.-variant "has set us back a lot" but that he is hopeful following weeks of tough restrictions that primary schools at least will be able to reopen in early March. "We're in a better place than I might have anticipated a month ago," he told POLITICO's Westminster Insider podcast. "The lockdown has really driven down cases quite fast. They’re basically halving about every 17 days at the moment or so, and that means in a month's time — the prime minister's talked about potentially reopening schools, we might have some bandwidth to do that, at least primary schools. And if we continue to see then a continued decline without large outbreaks, then perhaps starting to relax other aspects of society the following month."
14th Feb 2021 - POLITICO.eu

7 Virus Variants Found in U.S. Carrying the Same Mutation

In a study posted on Sunday, a team of researchers reported seven growing lineages of the novel coronavirus, spotted in states across the country. All of them have evolved a mutation in the same genetic letter. “There’s clearly something going on with this mutation,” said Jeremy Kamil, a virologist at Louisiana State University Health Sciences Center Shreveport and a co-author of the new study. It’s unclear whether it makes the variants more contagious. But because the mutation appears in a gene that influences how the virus enters human cells, the scientists are highly suspicious. “I think there’s a clear signature of an evolutionary benefit,” Dr. Kamil said.
14th Feb 2021 - The New York Times

COVID-19: Previously-infected people only need one vaccine shot, say French experts

France's top health authority has recommended that people who've had coronavirus only get one vaccine dose. Those who have recovered from the virus have built an immune response similar to that brought on by a vaccine, said the High Authority of Health (HAS). It said a single shot would "play the role of reminding" the person's body how to fight the infection. The vaccines approved by the European Union - made by Moderna, Pfizer and AstraZeneca - all stipulate two doses with a gap inbetween to achieve maximum protection.
13th Feb 2021 - Sky News

Coronavirus: Oxford-AstraZeneca vaccine trial to begin in February for children

A trial to test how well the Oxford-AstraZeneca coronavirus vaccine works in children is set to begin. Around 300 volunteers will take part in the trial, which will start at the end of February. The scientists want to see how well the vaccine works in children aged between six and 17 years old. Currently there are no plans to vaccinate children in the UK, but so far more than 14 million people have received one of the approved vaccines for coronavirus.
13th Feb 2021 - BBC News

AstraZeneca teams with IDT Biologika to speed coronavirus vaccine output in EU

AstraZeneca is teaming up with German CDMO IDT Biologika to quickly speed output of finished COVID-19 vaccine doses. And their pact doesn't stop with this pandemic. To address Europe's "immediate vaccination needs during the pandemic," the companies agreed to work together to speed output of finished AZ doses by the second quarter of this year, AstraZeneca said Wednesday. Their newly expanded deal has a broader goal as well—helping secure "Europe’s future vaccine supply independence" through combined investments in new capacity at IDT Biologika's Dessau, Germany, manufacturing site.
13th Feb 2021 - FiercePharma

After failing to deliver, AstraZeneca rethinks EU coronavirus vaccine supply chain

AstraZeneca is scrambling to find more manufacturers to produce its coronavirus vaccine in Europe after the drugmaker’s bet on a limited number of sites fell short. By the end of January, only one continental plant — located in Seneffe in Belgium — was authorized to manufacture the drug substance for the vaccine coveted by governments across Europe, alongside two sites in the U.K. and U.S. After announcing the company would be unable to deliver nearly two-thirds of the 100 million doses it promised the EU by the end of March, AstraZeneca CEO Pascal Soriot initially pointed the finger at the Belgian plant, now owned by U.S. company Thermo Fisher Scientific.
13th Feb 2021 - POLITICO.eu

White House cites ‘deep concerns’ about WHO COVID-19 report, demands early data from China

The White House on Saturday called on China to make available data from the earliest days of the COVID-19 outbreak, saying it has “deep concerns” about the way the findings of the World Health Organization’s COVID-19 report were communicated. White House national security adviser Jake Sullivan said in a statement that it is imperative that the report be independent and free from “alteration by the Chinese government”, echoing concerns raised by the administration of former President Donald Trump, who also moved to quit the WHO over the issue.
13th Feb 2021 - The Globe and Mail

Covid-19 pandemic: China 'refused to give data' to WHO team

China refused to hand over key data to the World Health Organization (WHO) team investigating the origins of Covid-19, one of its members has said. Microbiologist Dominic Dwyer told Reuters, the Wall St Journal and the New York Times the team requested raw patient data from early cases, what he called "standard practice". He said they only received a summary. China has not responded to the allegation but has previously insisted it was transparent with the WHO. The US has urged China to make available data from the earliest stages of the outbreak, saying it has "deep concerns" about the WHO report.
13th Feb 2021 - BBC News

Zinc, vitamin C show no effect for COVID-19 in small study

Consuming high doses of zinc and ascorbic acid (vitamin C) was not associated with improvement in COVID-19 infections, according to a small study published today in JAMA Network Open. In a 214-person, open-label experiment with COVID outpatients in Ohio and Florida, those who received one or both supplements had similar symptom-reduction periods as those who received standard of care. Over the years, scientific studies have not conclusively shown that either supplement can help overcome illnesses such as the common cold. Since the pandemic began, however, both supplements have seen an increased market owing to people's belief that they can give the immune system a boost. The New York Times reported zinc sales of $134 million, and USA Today found that vitamin C sales reached $209 million during the first half of 2020, up 76% compared with 2019.
13th Feb 2021 - CIDRAP

Oxford University to test COVID-19 vaccine response among children for first time

The University of Oxford has launched a study to assess the safety and immune response of the COVID-19 vaccine it has developed with AstraZeneca Plc in children for the first time, it said on Saturday. The new mid-stage trial will determine whether the vaccine is effective on people between the ages of 6 and 17, according to an emailed statement from the university. Around 300 volunteers will be enrolled and first inoculations are expected this month, Oxford said. The two-dose Oxford/AstraZeneca vaccine has been hailed as a ‘vaccine for the world’ because it is cheaper and easier to distribute than some rivals.
13th Feb 2021 - Reuters

All hypotheses on Covid-19 origins still being investigated, says WHO boss

The World Health Organization says it has not ruled out any theory on the origins of the coronavirus pandemic, despite one top official earlier this week appearing to dismiss the idea it had escaped from a laboratory. Speaking at a briefing on Friday, Dr Tedros Adhanom Ghebreyesus, director-general of the WHO, said a summary report from the organization’s team sent to Wuhan to investigate the origins of the virus should be published next week, with a full report coming soon after. But he confirmed that while the scientists made progress in understanding the circumstances around the outbreak in Wuhan in late 2019, more work was needed on all of the potential routes the virus may have taken into the human population.
13th Feb 2021 - The Guardian

Statins 'cut risk of Covid death': Study finds cholesterol drugs taken by eight million Britons reduce chance of dying to virus by 43% in hospital patients

Statins tackle 'bad' blood cholesterol and they are used by eight million Britons A study has now found giving statins to Covid patients can reduce death risk The study was a review of 12 other studies into the effectiveness of statins in cutting mortality from coronavirus
13th Feb 2021 - Daily Mail

Virus variant first detected in the U.K. has been deadlier, study confirms

Scientists had already determined that the variant of the novel coronavirus first detected in the fall in the United Kingdom — known as B.1.1.7. because of its molecular makeup — was probably 30 to 70 percent more transmissible than the typical version of the virus causing covid-19. They also knew, based on preliminary data, that the variant appeared to be relatively more deadly for the growing number of people catching it. U.K. scientists now say the variant is probably 30 to 70 percent more deadly, based on a follow-up study by the government released Friday that assessed a larger sample size of covid-19 patients and also found a higher rate of hospitalization.
13th Feb 2021 - The Washington Post

England's current lockdown could be the last, says Neil Ferguson

The scientist whose data modelling led to the first UK lockdown has expressed hope that the current lockdown could be the last. Prof Neil Ferguson, who advises the government as part of the New and Emerging Respiratory Virus Threats advisory group (Nervtag), said the nation was “in a better place than I might have anticipated a month ago”. He told Politico’s Westminster Insider podcast: “The lockdown has really driven down cases quite fast. They’re basically halving about every 17 days at the moment or so, and that means in a month’s time – the prime minister’s talked about potentially reopening schools – we might have some bandwidth to do that, at least primary schools. “And if we continue to see then a continued decline without large outbreaks, then perhaps starting to relax other aspects of society the following month.”
12th Feb 2021 - The Guardian

New COVID variant with 5 mutations identified in California

A new SARS-CoV-2 variant, CAL.20C, has been detected in southern California amid a surge in local infections and is spreading through and beyond the United States, according to a research letter published in JAMA. Researchers at Cedars-Sinai Medical Center (CSMC) in Los Angeles analyzed COVID-19 strains before and after the surge in cases in southern California in October 2020. Before October, most coronavirus strains there originated from the 20C clade (group of viruses evolved from the same ancestor), which emerged in New York via Europe in the early stages of the pandemic. "SARS-CoV-2 will be with the global population for some time and has clearly shown its tendency toward rapid antigenic variation, providing a 'wake-up call' that a sustained effort to develop a pan-SARS-CoV-2 vaccine is warranted," the authors said.
12th Feb 2021 - CIDRAP

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Feb 2021

View this newsletter in full

Manitoba agrees to purchase 2M doses of Providence Therapeutics coronavirus vaccine

The Manitoba government has committed to buy two million doses of a made-in-Canada COVID-19 vaccine currently under clinical trial. Premier Brian Pallister announced the purchase of the Providence Therapeutics COVID-19 vaccine at a Thursday morning press conference. “With today’s announcement we’re taking a big step … to creating a secure, stable supply of Canadian-made COVID vaccines,” Pallister said. A human trial for the prospective vaccine was started in Toronto in late January. In a release Jan. 26 Providence said the vaccine, dubbed PTX-COVID19-B, is a messenger RNA (mRNA) vaccine, and is the first fully-made in Canada vaccine to reach the human clinical trial stage.
11th Feb 2021 - Global News

Bolivia signs deal with China´s Sinopharm for coronavirus vaccine

Bolivia said on Thursday it had inked an agreement with China´s Sinopharm locking in an initial supply of half a million doses of the company´s vaccine against coronavirus by the end of February. Bolivian President Luis Arce said China’s President Xi Jinping had agreed to sell Bolivia 400,000 doses and had donated another 100,000 doses to the South American nation, among the poorest in the region. Bolivia has been rocked by political and social upheaval since contested elections in 2019 saw longtime president Evo Morales leave office. It has lagged behind wealthier regional neighbors in securing bilateral vaccine supply deals. The Andean nation has since signed agreements with Russia for its Sputnik V vaccine and India’s Serum Institute for AstraZeneca’s COVID-19 shot. It has also signed a deal with the World Health Organization-backed COVAX initiative.
11th Feb 2021 - Reuters

Does the coronavirus vaccine work on Bristol's variant? This is what Public Health England says

Public Health England has shared a reassuring statement about Bristol's coronavirus variant in relation to vaccines. Several experts have raised doubts about the mutation present in this particular 'variant of concern', as experiments suggest it might make antibodies less effective in attacking the infection. Speaking to ITV last night (Wednesday, February 10), a member of the Scientific Advisory Group for Emergencies said the variant "may be able to re-infect people who’ve been previously infected or who’ve been previously vaccinated". However, Public Health England (PHE) remains optimistic about the efficacy of current vaccines - at least in the primary aim of preventing serious illness and death.Speaking to ITV last night (Wednesday, February 10), a member of the Scientific Advisory Group for Emergencies said the variant "may be able to re-infect people who’ve been previously infected or who’ve been previously vaccinated". However, Public Health England (PHE) remains optimistic about the efficacy of current vaccines - at least in the primary aim of preventing serious illness and death.
11th Feb 2021 - Bristol Live

AstraZeneca Plans to Double Covid-19 Vaccine Output

AstraZeneca PLC said it was fixing problems with the manufacturing of its Covid-19 vaccine and expects to roughly double monthly production to 200 million doses by April, as it seeks to move past a rocky start to the shot’s rollout. The Anglo-Swedish drugmaker reported strong full-year earnings and forecast increased 2021 earnings growth. The forecast doesn’t factor in sales of the pandemic vaccine it developed alongside the University of Oxford.
11th Feb 2021 - Wall Street Journal

CDC: people who have received two Covid-19 vaccine doses can skip quarantine

People who have received the full course of Covid-19 vaccines can skip the standard 14-day quarantine after exposure to someone with the infection as long as they remain asymptomatic, US public health officials advised. The Centers for Disease Control and Prevention (CDC) said late on Wednesday the vaccines have been shown to prevent symptomatic Covid-19, thought to play a greater role in the transmission of the virus than asymptomatic disease. “Individual and societal benefits of avoiding unnecessary quarantine may outweigh the potential but unknown risk of transmission (among vaccinated individuals),” the CDC said.
11th Feb 2021 - The Guardian

Roche arthritis drug reduces COVID-19 deaths in trial in hospitalised patients

Roche's arthritis drug tocilizumab cuts the risk of death among patients hospitalised with severe COVID-19, also shortening the time to recovery and reducing the need for mechanical ventilation, results of a large trial showed on Thursday.
11th Feb 2021 - Nasdaq

When will kids be able to get COVID-19 vaccines?

Students as young as first grade might be able to get vaccinated against COVID-19 by September, White House chief medical adviser Dr. Anthony Fauci predicted in an interview published by ProPublica on Thursday. Fauci cited clinical trials now underway in the U.S. from vaccine developers Pfizer and Moderna to test the safety and efficacy of the doses in children. He had said previously that the Food and Drug Administration might allow for vaccinations in American children "by the time we get to the late spring and early summer." So far, except for a handful of errors, the nationwide vaccine rollout has not included children.
11th Feb 2021 - CBS News

Pfizer says it expects data on COVID-19 vaccines for children in 'early part of 2021'

Pfizer says it has completed enrollment of its clinical trial of 12-to-15 year olds and believes it will have data in 'the early part of 2021.' Moderna is still recruiting children for its trial if 12-to-18 year olds and says it expects to have preliminary data 'around mid-year 2021.' Neither company has yet started pediatric trials testing their coronavirus vaccines in those aged 11 and younger Dr Anthony Fauci says he believes children as young as first graders may be able to receive COVID-19 vaccines by the school year start in September. But pediatricians believe studies are moving too slowly and that not immunizing children threatens herd immunity and increases the risk of variants spreading
11th Feb 2021 - Daily Mail

Government ordered to investigate link between PPE shortages and NHS COVID-19 deaths

A report by the House of Commons public accounts committee (PAC) highlighted concerns among frontline staff that guidance did not specify a high enough level of PPE to properly protect them against infection, while some supplies were substandard or insect-infected. Black, Asian and minority ethnic (BAME) staff were more likely to report experiencing PPE shortages or feeling pressured to work without adequate protection - over twice as many BAME doctors reported experiencing PPE shortages compared with white colleagues. The BMA has urged the government to learn from ‘these terrible shortcomings’ and listen to the experiences of frontline workers during the first wave of the pandemic to ensure that healthcare workers are properly protected in the future.
11th Feb 2021 - GP online

COVID-19 linked with new set of symptoms, according to study of over a million people

Chills, loss of appetite, headache and muscle aches could be a sign of COVID-19 infection, according to new findings. Based on swab tests and questionnaires taken from June up until last month as part of Imperial College London's REACT study of over one million people, those with the above symptoms were more likely to test positive for the virus. This is in addition to the "classic" symptoms of COVID-19 already included in NHS guidance, which are: - Fever - New persistent cough - Loss of sense of smell and/or taste
11th Feb 2021 - Sky News

Bristol Covid-19 variant: Experts monitor new mutation

A new coronavirus variant found in Bristol may be able to infect people who have already had Covid-19 or who have been vaccinated. But experts said jabs will still protect against people becoming seriously ill with the disease. The Bristol variant contains the E484K mutation also found in the South African and Brazilian variants. Health officials in the city say getting as many people vaccinated as possible is key. The Bristol variant has been defined by the New and Emerging Respiratory Virus Threats Advisory Group (Nervtag) as the Kent variant with the E484K mutation. Laboratory studies have shown that viruses with that mutation are able to escape human defences, making them more efficient at evading natural and vaccine-triggered immunity.
11th Feb 2021 - BBC News

'More than 40% of people suffer trauma following Covid-19′

Many people suffer trauma with symptoms such as flashbacks after catching Covid-19, even if they did not require clinical assistance or hospitalisation, a study has found. The Imperial College London and University of Southampton study, published on Tuesday, looked at 13,049 people with experience of coronavirus.
11th Feb 2021 - Pulse Today

COVID-19: AstraZeneca on course to roll out jab for new variants by autumn

AstraZeneca has said it is on course to roll out a coronavirus vaccine that is effective against new variants by the autumn. The company, which has produced a COVID-19 vaccine alongside University of Oxford, said clinical trials for the next generation of jab would commence in the spring.
11th Feb 2021 - Sky News

Is It Safe to Delay a Second COVID Vaccine Dose?

Vaccine shortages and distribution delays are hampering efforts to curb the SARS-CoV-2 pandemic. So some scientists have suggested postponing the second shots of two-dose vaccines to make more available for people to get their first doses. The original recommended interval was 21 days between doses for the Pfizer vaccine and 28 days for the Moderna shots, the two currently authorized in the U.S. Now the U.S. Centers for Disease Control and Prevention has updated its guidance to say that people can wait up to 42 days between doses, though the agency still advises individuals to stick to the initial schedule. And developers of the University of Oxford–AstraZeneca vaccine—which is authorized for use in the U.K.—suggest even longer stretches are possible, saying their shot performs better when its doses are spaced 12 weeks apart.
11th Feb 2021 - Scientific American

AstraZeneca working to adapt Covid-19 vaccine to new strains

AstraZeneca said Thursday it's working with the University of Oxford to adapt its COVID-19 vaccine to protect against new strains of the virus as public health officials raise concerns about mutations that may make the virus more resistant to existing vaccines. The Anglo-Swedish drugmaker worked with Oxford to develop one of the first COVID-19 vaccines authorized for widespread use. AstraZeneca said it hopes to cut the time needed to produce large amounts of any new vaccine to between six and nine months.
11th Feb 2021 - Business Standard

C.D.C. Urges Better Masking for Increased Virus Protection

Wearing a mask — any mask — reduces the risk of infection with the coronavirus, but wearing a more tightly fitted surgical mask, or layering a cloth mask atop a surgical mask, can vastly increase protections to the wearer and others, the Centers for Disease Control and Prevention reported on Wednesday. New research by the agency shows that transmission of the virus can be reduced by up to 96.5 percent if both an infected individual and an uninfected individual wear tightly fitted surgical masks or a cloth-and-surgical-mask combination.
11th Feb 2021 - The New York Times

Long Covid: The illness wreaking havoc behind the pandemic

Coronavirus has been dominating the headlines for a year – but behind the grim death statistics and hospital admissions, a related illness has been quietly wreaking havoc on the lives of thousands of Scots. Long Covid, or post-covid syndrome, has been described by some as the “pandemic behind the pandemic”. Research is in its infancy and there is no clear treatment or cure. The post-viral condition affects people who fell ill with coronavirus, but did not make a full recovery within three months.
11th Feb 2021 - STV News

Kent Covid variant mutation must be taken seriously, warns UK scientist

The Kent variant of the coronavirus with a key mutation that enables the South African variant to escape some of the vaccines used against it must be taken very seriously in the UK, according to a leading microbiologist. Prof Ravi Gupta of the Cambridge Institute for Therapeutic Immunology and Infectious Diseases, who is a member of the government’s scientific advisory body Nervtag, warned that the mutated variant, at the moment causing just 21 known cases, should be treated with as much concern as the South African variant. The Kent variant B117, which spreads twice as fast as the original coronavirus, is now dominant in the UK and is present in many countries around the world. But Public Health England has identified 21 cases of B117 that also have the E484K mutation: 14 in the Bristol region, four in Greater Manchester and three elsewhere. E484K is the change to the spike protein in South Africa that scientists believe is chiefly responsible for vaccines triggering a lower antibody response to infection.
11th Feb 2021 - The Guardian

CDC alters COVID-19 quarantine guidance for vaccine recipients

If you have received two doses of the COVID-19 vaccine and are exposed to someone with the virus, you no longer have to quarantine for 14 days as long as you remain free of symptoms, according to new recommendations issued by the Centers for Disease Control and Prevention (CDC). Because the vaccines prevent symptomatic COVID-19 infections, and symptomatic people are thought to be more contagious, the CDC said the risk of unnecessary quarantine outweighs the potential unknown risk of transmission among vaccinated people.
11th Feb 2021 - CIDRAP

Tocilizumab cuts death rate in severe COVID-19, study finds

Hospitalized COVID-19 patients given the anti-inflammatory monoclonal antibody tocilizumab were less likely to die or require invasive mechanical ventilation, according to preliminary results of the UK RECOVERY trial posted today on the medRxiv preprint server. Led by University of Oxford researchers, the ongoing Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial involved assigning 4,116 severely ill coronavirus patients to receive either intravenous tocilizumab, a rheumatoid arthritis drug, or usual care. Most (82%) of the participants also received a systemic corticosteroid such as dexamethasone.
11th Feb 2021 - CIDRAP

Merck canned its own COVID-19 vaccines. Now, it's in talks to manufacture other companies' shots

After Merck & Co. got off to a late start in the COVID-19 vaccine race and made an early exit, the drug giant is in talks to aid the global vaccine manufacturing effort. The drugmaker is “actively involved” in discussions with governments, health agencies and other pharmaceutical companies to “identify the areas of pandemic response where we can play a role, including potential support for production of authorized vaccines," a spokesman said via email. News of the talks comes about two weeks after Merck abandoned both its coronavirus vaccine candidates—one it acquired through its Themis buyout and the other it was studying in partnership with IAVI. Merck said the two shots had produced immune responses weaker than those prompted by natural infections as well as by other COVID-19 vaccines.
11th Feb 2021 - FiercePharma

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Feb 2021

View this newsletter in full

Single dose of Pfizer vaccine shows signs of success in UK

Official data from the UK’s vaccination campaign show that a single dose of the BioNTech/Pfizer jab offers good protection against Covid-19, boosting the government’s approach of extending the gap between doses. Although not enough evidence is available to draw definitive conclusions about the impact of the vaccination campaign on deaths and hospitalisations, several people with access to government data said indications showed it was reducing cases in the groups prioritised to receive the jab.
11th Feb 2021 - Financial Times

A lone infection may have changed the course of the pandemic

In each warm body it infects, the virus behind Covid-19 has the potential to change. It can become more deadly, more transmissible or more resistant to the vaccines on which we are all pinning so much hope. Mercifully, the biology of Sars-CoV-2 means that such changes happen slowly and almost always fail to catch on. But mutations, like pandemics, are a numbers game. Every new person infected provides another opportunity for the virus to adopt a new form. So far, Sars-CoV-2 has infected at least 106 million people worldwide and taken on many thousands of mutations. Most of those changes are slow and inconsequential – evolutionary dead ends that nobody will ever realise existed. But, in some people, the virus hits the jackpot.
11th Feb 2021 - Wired.co.uk

Pfizer/BioNTech vaccine could reduce Covid-19 viral load - what it means

New data gathered by researchers in Israel suggests that the Pfizer/BioNTech Covid vaccine is reducing the viral load of the virus. Israel has already vaccinated around one in three residents, after beginning its vaccine deployment program on 20 December. According to a paper which was published on Monday (8 Feb), positive test results of patients aged 60 and over had up to 60 per cent smaller viral loads on the swab, compared to the 40 to 59 age group. The paper explains that this is because, by this point, at least 14 days have passed since more than 75 per cent of the over-60s age group received their first dose, in comparison to the 25 per cent of 40 to 60 year olds.
10th Feb 2021 - The Scotsman on MSN.com

Teva Is in Discussions to Help Make Covid-19 Vaccines, CEO Says

Teva Pharmaceutical Industries Ltd. is in talks with Covid-19 vaccine makers about helping to produce and distribute shots as demand rises for immunizations. The generic drug giant is offering to dedicate its manufacturing capacity in the U.S., Europe and beyond to aid with mass-immunization efforts geared at combating the pandemic, Chief Executive Officer Kare Schultz said Wednesday. “We have a large, worldwide network of manufacturing capabilities,” from creating underlying drug substances to putting solutions into sterile vials, known as the fill-finish process, he said in an interview. “There are a limited number of facilities that can do this kind of manufacturing, and it takes time to build them.”
10th Feb 2021 - Bloomberg on MSN.com

Coronaviruses linked to Covid-19 circulating in bats and pangolins in Southeast Asia, study finds

Coronaviruses similar to that which causes Covid-19 may be circulating in bats and pangolins in Southeast Asia, a study has found. In a breakthrough that provides clues for those investigating the origin of the pandemic, scientists said high levels of neutralising antibodies against coronaviruses were present in the animals in Thailand. A team from Singapore’s Duke-NUS Medical School found SARS-CoV-2 – the virus that causes Covid-19 – neutralising antibodies in Rhinolophus bats in a Thai cave and in a pangolin at a wildlife checkpoint in the south of the country. The findings, published in the journal Nature Communications, indicate more coronaviruses are likely to be discovered across Southeast Asia, which has a large and diverse bat population, the researchers said. Such viruses have now been found across a wide expanse measuring 4,800 km, from Japan and China to Thailand.
10th Feb 2021 - The Independent

Study Links Four New Symptoms To Covid-19 Infection, Including Headaches And Loss Of Appetite

In a study of more than 1 million people in England between June 2020 and January 2021, researchers identified chills, loss of appetite, headaches and muscle aches as additional symptoms linked with having Covid-19. Some symptoms vary by age, with headaches most reported in children and teens (between 5-17 years old), who are less likely to report “classic” Covid-19 symptoms, and adults over 55 reporting appetite loss.
10th Feb 2021 - Forbes

CDC study finds two masks are better than one vs. COVID-19

US government researchers have found wearing two masks was better than one when preventing the spread of Covid-19, according to a Centres for Disease Control and Prevention (CDC) study. In a lab experiment, two artificial heads were placed six feet from each other and studied on how many coronavirus-sized particles were expelled and inhalled while wearing a variety of face coverings. Researchers found that wearing one mask, either cloth or surgical, prevented 40 per cent of incoming droplets from being breathed in. When adding a surgical mask underneath a cloth mask, 80 per cent of incoming droplets were stopped.
10th Feb 2021 - The Independent

AstraZeneca to build new Covid-19 vaccine facility in Germany

AstraZeneca has unveiled plans to build a new Covid-19 vaccine manufacturing facility in partnership with IDT Biologika at the German firm’s Dessau site, in a move aiming to speed up production and defuse a row with the EU over vaccine supply.
10th Feb 2021 - The Guardian on MSN.com

Covid-19: Sports equipment presents 'low risk'

The risk of coronavirus transmission from sharing sports equipment is "lower than once thought", a study suggests. Researchers, led by Liverpool School of Tropical Medicine, applied live virus particles to nine types of sports equipment and a control material. They concluded it "seems unlikely" that sports balls and accessories are a major cause for transmission. Prime Minister Boris Johnson said last June that cricket balls are a "natural vector" of coronavirus. The Strike study found the virus was least transferrable on absorbent materials like cricket gloves and tennis balls, compared with non-porous equipment like racing saddles and rugby balls.
10th Feb 2021 - BBC News

David Oliver: Mistruths and misunderstandings about covid-19 death numbers

I want to set the record straight about some serious misinformation surrounding covid-19 death certification and mortality statistics. I will paraphrase some of the claims that I have heard repeatedly in the media: “People are not dying from, but with, covid-19.” “Deaths classified as from covid-19 result from largely false positive polymerase chain reaction (PCR) test results,” “deaths are mostly from other causes and underlying conditions,” “death numbers are grossly inflated,” “there is no excess mortality compared with other years or months,” and this is “no different from a normal flu season.” Let’s see, shall we? According to the Office for National Statistics (ONS), the total number of deaths with covid-19 recorded on the death certificate in England and Wales has now passed 100 000. The government’s daily press releases, however, report “deaths within 28 days of a positive test result”—a definition repeated faithfully by broadcast and print journalists and on social media. This approach probably under-recognises the real number of deaths from covid-19 by around 20%.
10th Feb 2021 - The BMJ

In Spain, patients with serious conditions left out of AstraZeneca early vaccination

The Covid vaccine made by AstraZeneca will for now only be administered to essential workers in Spain, including teachers, law enforcement officers, firefighters and members of the armed forces – but not supermarket workers. Although the treatment has been approved by European authorities for anyone over the age of 18, the Spanish government is taking a conservative approach: first it ruled out people over 80 years of age, then it further reduced the target group to those under 55. And on Tuesday, a committee of experts advising the National Healthcare System established that individuals under 55 with certain pre-existing medical conditions will also be left out, at least during the initial phase.
10th Feb 2021 - EL PAÍS in English

Japan suffers rise in female suicides during Covid-19 pandemic

A much-anticipated inquiry into the origins of the coronavirus pandemic wrapped up its mission in China on Tuesday with no breakthrough discovery, as investigators ruled out a theory that Covid-19 came from a lab while failing to identify which animal may have passed it to humans. It remains unclear which species first transmitted Covid-19 to humans, said Liang Wannian, who headed up the Chinese contingent of an inquiry carried out jointly with World Health Organization experts. The WHO mission -- which China repeatedly delayed -- was dogged by fears of a whitewash, with the US demanding a "robust" probe into the origins of the pandemic in late 2019, and China firing back with a warning not to "politicise" the investigation. During the closely monitored mission, which included a visit to an exhibition celebrating China's recovery, reporters were largely kept at arm's length from the experts.
10th Feb 2021 - Financial Times

Covid origins still a mystery as WHO-China probe ends

Vaccine vs variant: Promising data in Israel's race to defeat pandemic

Israel’s swift vaccination rollout has made it the largest real-world study of Pfizer Inc’s COVID-19 vaccine. Results are trickling in, and they are promising. More than half of eligible Israelis - about 3.5 million people - have now been fully or partially vaccinated. Older and at-risk groups, the first to be inoculated, are seeing a dramatic drop in illnesses. Among the first fully-vaccinated group there was a 53% reduction in new cases, a 39% decline in hospitalizations and a 31% drop in severe illnesses from mid-January until Feb. 6, said Eran Segal, data scientist at the Weizmann Institute of Science in Rehovot, Israel.
10th Feb 2021 - Reuters UK

Ohio underreported as many as 4,000 COVID-19 deaths

Ohio will add as many as 4,000 previously unreported COVID-19 deaths to the state's tally during the next week after the Ohio Department of Health discovered reporting errors dating back to October. Most of these deaths occurred in November and December, the agency said in a news release, already the deadliest two months of the pandemic with 1,574 and 2,859 deaths, respectively. The correction will result in a few days of higher-than-average death totals, the agency warned. The actual date of death will be reflected on the state's coronavirus dashboard.
10th Feb 2021 - Cincinnati Enquirer on MSN.com

WHO recommends use of Oxford/AstraZeneca vaccine for all adults

The World Health Organization has recommended the Oxford/AstraZeneca coronavirus vaccine for use worldwide by all adults, including the elderly, in a boost for the jab after a series of setbacks. The WHO’s Strategic Advisory Group of Experts on Immunization (Sage) said the vaccine could be used by all people over the age of 18 in all countries, including places such as South Africa where the circulation of new variants had raised some concerns over its efficacy. Some countries, such as France and Sweden, have restricted use of the shot to younger adults, citing a lack of sufficient trial data for the elderly, but WHO officials stressed on Wednesday that not all nations had a choice of which vaccine to use.
10th Feb 2021 - Financial Times

AstraZeneca agrees German manufacturing deal to fill vaccine gap

AstraZeneca has enlisted German drug manufacturer IDT Biologika to help boost production of its Covid-19 vaccine and tackle supply shortages in Europe. Relations between the EU and AstraZeneca deteriorated after the pharma group announced last month that it would fall far short on its promise to deliver the bloc at least 100m doses of the vaccine, developed with Oxford university, in the first quarter. AstraZeneca has since revised its first-quarter delivery forecast up from 31m to 40m doses, and announced that it would expand manufacturing capacity in Europe.
10th Feb 2021 - Financial Times

Did we underestimate Russia’s vaccine?

Not long ago, talk of the Russian-made coronavirus vaccine provoked mockery. “There’s no way in hell the U.S. tries this on monkeys, let alone people,” a Trump administration official told CNN in August, referring to initial reports about Russia’s development of the Sputnik V drug — which bypassed traditional steps in testing before its release. Even at home, where a history of political opacity and bureaucratic incompetence has left a lingering distrust of authority, many ordinary Russians shied away from getting the jab once it was made available to the public in December.
10th Feb 2021 - Washington Post

Feds focus on mask upgrades, COVID-19 vaccine sites

Today the Centers for Disease Control and Prevention (CDC) released new data showing the fit of face masks—both cloth and surgical—can significantly reduce COVID-19 transmission, by as much as 96.5% if both infected and uninfected people wear them properly. "What we know now is everyone needs to be wearing a mask when they are in public or inside with people from outside their households," said Rochelle Walensky, MD, director of the CDC during a press briefing today.
10th Feb 2021 - CIDRAP

WHO advisors recommend AstraZeneca COVID vaccine for emergency use

The World Health Organization (WHO) vaccine advisory group today recommended the AstraZeneca-Oxford vaccine for emergency use, a key development that clears the way for lower- and middle-income countries to receive their first deliveries from the COVAX program. In other global developments, the WHO said in a weekly update that overall cases and deaths show more signs of decline, a promising development, though cases are rising in some nations and more countries are reporting the detection of variant SARS-CoV-2 viruses.
10th Feb 2021 - CIDRAP

COVID deaths 3 times higher in nursing homes with more non-white residents

Residents of US nursing homes with more than 40% non-white residents died of COVID-19 at 3.3 times the rate of those of those with higher proportions of white residents, a study today in JAMA Network Open shows. Using the Nursing Home COVID-19 Public File from the Centers for Medicare & Medicaid Services, University of Chicago researchers found that nursing homes with the lowest shares of white residents reported a mean of 5.6 deaths, compared with 1.7 in those with the highest proportions, as of Sep 13, 2020.
10th Feb 2021 - CIDRAP

BioNTech gets rolling with mRNA production at former Novartis site in Marburg

BioNTech, under pressure with its COVID-19 vaccine partner Pfizer to manufacture as many doses as possible this year, has started production at a former Novartis site it acquired in Germany. The drugmaker has started making messenger RNA at the site, kicking off the manufacturing process for its Pfizer-partnered COVID-19 vaccine. BioNTech expects to produce up to 250 million doses of its vaccine there in the first half of 2021, and up to 750 million doses annually when the site is fully online. The first vaccines produced there will be ready in early April, BioNTech said.
10th Feb 2021 - FiercePharma

Eli Lilly scores FDA nod for COVID-19 antibody cocktail, aims to make 1M doses by midyear

Two weeks after Eli Lilly unveiled data showing its COVID-19 antibody cocktail of bamlanivimab and etesevimab slashed the risk of death and hospitalization for high-risk patients, the cocktail has won its emergency FDA authorization. Tuesday, the FDA authorized the combo for patients who have mild to moderate cases of COVID-19 but are at high risk of progressing to severe disease. The company and its manufacturing partner Amgen aim to produce up to 1 million doses of the cocktail by the middle of the year. In the trial of more than 1,000 high-risk patients with newly diagnosed COVID-19, just 11 patients who received the bamlanivimab-etesevimab combo were hospitalized and none died. That compared with 36 hospitalizations and 10 deaths among placebo patients, which translates into a 70% reduction in the risk of a COVID-19 hospitalization or death.
10th Feb 2021 - FiercePharma

Could a Single Vaccine Work Against All Coronaviruses?

The invention of Covid-19 vaccines will be remembered as a milestone in the history of medicine, creating in a matter of months what had before taken up to a decade. But Dr. Kayvon Modjarrad, the director of Emerging Infectious Diseases Branch at Walter Reed Army Institute of Research in Silver Spring, Md., isn’t satisfied. “That’s not fast enough,” he said. More than 2.3 million people around the world have died, and many countries will not have full access to the vaccines for another year or two: “Fast — truly fast — is having it there on day one.”
9th Feb 2021 - The New York Times

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Feb 2021

View this newsletter in full

Are two masks better than one?

When it comes to protecting yourself against new coronavirus variants, two masks may be better than one. A number of politicians, including Vice President Kamala Harris and Senator Mitt Romney, have been spotted doubling up on face masks, and top infectious disease expert Anthony Fauci has recommended that everyday Americans do the same. As part of our #AskReuters Twitter chat series, Reuters gathered a group of health experts to answer questions about the coronavirus, including what they consider the “right” way to wear face coverings.
10th Feb 2021 - Reuters

Eli Lilly's antibody combination receives FDA emergency use authorization for COVID-19

Eli Lilly’s combination antibody therapy to fight COVID-19 has been granted emergency use authorization by the U.S. Food and Drug Administration, Lilly said on Tuesday. Lilly’s combination therapy of two antibodies, bamlanivimab and etesevimab, helped cut the risk of hospitalization and death in COVID-19 patients by 70%, data from a late-stage trial showed in January. Lilly said the therapy will be available immediately.
10th Feb 2021 - Reuters

Covid-19 vaccines will turn virus into ‘the sniffles’, says Oxford professor

Inoculation could turn coronavirus into “the sniffles” even if it cannot stop variants causing illness, according to a vaccine expert. Professor Andrew Pollard, head of the Oxford Vaccine Group, which conducts studies of new and improved vaccines, told MPs that he believed vaccines would have a “huge impact on transmission” of the variants that had been identified in the Britain.
9th Feb 2021 - The Times

China's CanSino single-dose COVID-19 vaccine co-developed by Beijing's top military bio-warfare expert 'shows 65.7 per cent efficacy'

A single-dose COVID-19 vaccine developed by Chinese firm CanSino Biologics and a team led by Beijing's top military bio-warfare expert is reported to show 65.7 per cent efficacy in preventing symptomatic cases. The drug also demonstrated a 90.98 per cent success rate in stopping severe disease in an interim analysis of global trials, according to Pakistan's health minister who posted the figures on Monday. Chen Wei, a Major General of China's People's Liberation Army, headed a team of scientists from the Chinese military to work on the inoculation with CanSino Biologics (CanSinoBIO), a biotechnology company based in Tianjin and listed on Hong Kong Stock Exchange.
9th Feb 2021 - Daily Mail on MSN.com

Firm producing Novavax coronavirus vaccine outlines 'strong pipeline' of potential Covid partners

A firm chosen to manufacture millions of doses of coronavirus vaccines says it has a “strong pipeline” of companies that want to work with it in the battle against the pandemic. Teesside firm Fujifilm Diosynth Biotechnologies has recently been contracted to manufacture 60m doses of the Novavax vaccine at its Billingham site. Now it has released accounts for the year ending March 31 2020 which show that operating profit rose £900,000 to £23m even as revenues fell by 9% to £114.2m. The year saw the company invest in its facilities while it added almost 80 new employees to its headcount. In the accounts, the company said: “This result has been driven by a sustained demand for batch manufacture across the small scale, large scale and mammalian sectors and analytical services which continues to grow from strength to strength. “As the company continues to grow it has seen an increase in operational fixed costs to support this growth, however, the company continues to benefit from research and development expenditure credit which has offset this increase.”
9th Feb 2021 - Business Live

India says J&J interested in making COVID-19 vaccine in country

Johnson & Johnson is interested in manufacturing its COVID-19 vaccine in India, a government official told a news conference on Tuesday. India also currently has no concern over the efficacy of the AstraZeneca vaccine that is being used in the country’s massive inoculation campaign, Vinod Kumar Paul said.
9th Feb 2021 - Reuters

Common asthma medicine cuts need for COVID-19 hospitalization - Oxford study

A commonly used asthma treatment appears to reduce the need for hospitalizations as well as recovery time for COVID-19 patients if given within seven days of symptoms appearing, researchers at the University of Oxford said on Tuesday. The findings were made following a mid-stage study of the steroid budesonide, sold as Pulmicort by AstraZeneca Plc and also used for treating smoker's lung. The 28-day study of 146 patients suggested that inhaled budesonide reduced the risk of urgent care or hospitalization by 90% when compared with usual care, Oxford University said. Researchers said the trial was inspired by the fact that patients with chronic respiratory disease, who are often prescribed inhaled steroids, were significantly under-represented among hospitalized COVID-19 patients during early days of the pandemic.
9th Feb 2021 - Reuters on MSN.com

‘Covid-19 is wrecking people’s mental health’

The effects of the coronavirus pandemic is destroying our ability to connect with friends and family, disrupting our routines and consequently damaging our mental health, a professor of psychology has said. “If you had designed a disease that was specifically figured out to wreck our mental health, Covid would be it,” Prof Laurie Santos told BBC Hardtalk’s Stephen Sackur. Humans hate uncertainty, but the pandemic is seeing constantly changing lockdowns and a continued flux about when things will improve, all of which is bad for our mental health, she explained.
9th Feb 2021 - BBC News

WHO investigation into Covid-19 origins offers no quick answers

The press conference given by the World Health Organization’s investigative team in Wuhan is unlikely to silence the most conspiratorial of the conspiracy theorists who took their lead from the fever dreams of the former Trump administration. Indeed, the first and very partial findings in what was always going to be a long and drawn-out process have not told us much we did not already know about the origins of the coronavirus pandemic. Except, that is, to confirm what has long been a broadly held scientific consensus: that the virus did not escape from a Wuhan laboratory as suggested by Donald Trump’s allies and their cheerleaders.
9th Feb 2021 - The Guardian

New research to study whether Covid-19 causes strokes

A new research study will investigate reports that Covid-19 is causing life-threatening strokes. The study is being funded by the Stroke Association following what they described as "worrying" reports Covid-19 may increase the risk of having a stroke, using health data from patients across the UK. Data analysts will compare stroke in patients who have tested positive for the virus with those without it, along with characteristics including age, sex, ethnicity and geography to confirm who is most at risk. Research director at the Stroke Association Dr Rubina Ahmed said they're worried Covid-19 may lead to more strokes. In Northern Ireland, there are around 4,000 strokes every year. There are currently 39,000 stroke survivors.
9th Feb 2021 - Belfast Telegraph

Covid-19: How the UK’s gene-sequencing labs could track every single case and help stop new variants

In the debate about how quickly to reopen the UK after the current lockdown, there are broadly two camps: those – including many Conservative backbenchers – who want the restrictions removed at pace in order to restart the economy, and those who lean towards a “zero Covid” strategy which would aim at the complete elimination of coronavirus from Britain. Much will depend on the progress of the vaccination roll-out, and the extent to which vaccines are shown to cut both serious illness and the transmission of the virus. And border controls – including those being set out by Matt Hancock on Tuesday – will continue to be part of the UK’s defences against Covid-19 for the rest of this year at least.
9th Feb 2021 - iNews

COVID-19: 'Extremely unlikely' coronavirus came from Wuhan lab as evidence points to 'intermediary species'

It is "extremely unlikely" the novel coronavirus came from a laboratory incident in China, according to a joint mission investigating the origins of the pandemic. Investigators believe the most likely cause of the initial outbreak was the virus jumping from an "intermediary host species" to humans. It means future investigations will not focus on a laboratory incident as a potential cause of the outbreak. An international team of World Health Organisation (WHO) scientists, working with experts in China, has been researching how the COVID-19 pandemic began.
9th Feb 2021 - Sky News

COVID-19: NHS Test and Trace app has prevented 600,000 cases, study suggests

As many as 600,000 coronavirus cases have been prevented as a result of the NHS COVID-19 app, new research suggests. Scientists at The Alan Turing Institute and Oxford University found that for every 1% increase in app users, the number of infections falls by up to 2.3%. The analysis, which is yet to be peer-reviewed, is based on data gathered in between the app launching in September and the end of last year. "The impact of the app could be increased by more people using it," said Professor Christophe Fraser at the University of Oxford.
9th Feb 2021 - Sky News

Britain could be trapped in lockdown cycles for 'several YEARS', top SAGE scientist warns

Prof Sir Ian Boyd said UK could be stuck in 'control and release for long time.' Threw support behind longer lockdown to stop more variants from spawning. Several other SAGE scientists came out in favour of extending current curbs
9th Feb 2021 - Daily Mail

Study to examine psychological impact of lockdown

A new study looking at the psychological impact of Covid-19 restrictions and lockdowns is under way at Dundalk IT. The study is being led by University College London and is being carried out in 23 countries, including Ireland, the UK, Australia, USA, Italy, Poland, Portugal, Turkey and Norway. Researchers say there is no research on how lockdown during a pandemic, involving restrictions to freedom of movement, is perceived by the general population.
9th Feb 2021 - RTE Online

Vaccines Aren't the Only Thing We Need to Safely Reopen

The recent surge of positive COVID-19 vaccine developments has sent waves of relief throughout a pandemic-weary world. However, no matter how effective these vaccines are, they will not be enough to end this global pandemic—and for many of the world’s most vulnerable communities, they won’t arrive fast enough. The Moderna and Pfizer vaccines were developed in record time. However, these announcements highlight significant challenges: delivering two-dose vaccines with stringent cold-chain requirements to almost eight billion people, many of whom reside in communities with underfunded and strained health systems, is no small feat. Even if we address the logistical challenges, the reality is that it takes time and funding to deliver vaccines, treatments and tests that reach everyone in need. It is a sobering reminder that when lifesaving antiretrovirals were introduced for HIV-positive people, it took seven years before the medicine reached the poorest communities. And during that time, millions of people died, and millions more were infected, and the HIV pandemic continued to grow.
9th Feb 2021 - Scientific American

WHO team: Coronavirus unlikely to have leaked from Chinese lab

The coronavirus is unlikely to have leaked from a Chinese lab and is more likely to have jumped to humans from an animal, a World Health Organization team has concluded, an expert said Tuesday as the group wrapped up a visit to explore the origins of the virus. The Wuhan Institute of Virology in central China has collected extensive virus samples, leading to allegations that it may have caused the original outbreak by leaking the virus into the surrounding community. China has strongly rejected that possibility and has promoted other theories for the virus’s origins. The WHO team that visited Wuhan, where the first cases of COVID-19 were discovered in December 2019, is considering several theories for how the disease first ended up in humans, leading to a pandemic that has now killed more than 2.3 million people worldwide.
9th Feb 2021 - POLITICO

Top scientists including US Covid expert Anthony Fauci call for double-masking to slash the spread of coronavirus but experts say claim it works better than one is not 'grounded in science'

Dr Anthony Fauci said it was 'common sense' to wear two masks at the same time But other experts have cautioned there is no 'strong evidence' for this Face masks stop Covid-19 from spreading by blocking infected droplets
9th Feb 2021 - Daily Mail

China probe says SARS-CoV-2 jump from go-between host most likely

Representatives from China and an international joint mission team led by the World Health Organization (WHO) today in Wuhan detailed the results of a 2-week probe into the zoonotic source of the outbreaks, which didn't reveal a definitive source but did shed new light on the events. At the nearly 3-hour briefing, officials laid out four main theories, some of them less likely possibilities. The 10-person joint mission team has been in China since Jan 14 and followed investigation terms that a WHO advance team fleshed out with the country over the summer.
9th Feb 2021 - CIDRAP

Pfizer/BioNTech vaccine reducing viral load, data from Israel suggests

Data from researchers in Israel, which has inoculated swathes of its population, suggests the Pfizer/BioNTech vaccine is reducing viral load, a key signal that the intervention could diminish the spread of Covid-19. Evidence that the coronavirus vaccines being deployed globally are dramatically effective in reducing severe disease and death in symptomatic Covid-19 is abundant. But a big question remains unanswered: can they thwart transmission, in other words stop people from passing on the virus? Preventing the spread of infection is key to reducing the risk of more variants emerging and to achieving herd immunity, scientists say. People with higher viral load tend to be more infectious and are more likely to suffer from severe disease.
9th Feb 2021 - The Guardian

It’s not the ‘British variant.’ It’s B.1.1.7

When President Trump referred to the “Chinese virus,” the media were quick to point out problems with this terminology, lambasting it as xenophobic and racist. But as new variants appear, some media outlets are doing the same thing: talk of the “British,” “Brazilian,” and “South African” Covid-19 variants abounds. Even scientific journals are using this terminology. But labeling viral variants by their geographic origin is incorrect. Just as the “China virus” should be called SARS-CoV-2 or the novel coronavirus, so too should new variants be described by their proper nomenclature: B.1.1.7, not “U.K. variant” and P.1, not the “Brazilian variant.”
9th Feb 2021 - Stat News

A Q&A with WHO’s emergencies chief on Covid-19, why he’s hopeful, and when normalcy might return

This time last year, Mike Ryan, head of the World Health Organization’s health emergencies program, was strenuously urging the world to try to contain the new virus that was spreading in and from China. The world, he said, had the necessary tools: contact tracing, isolation, and quarantine. “There’s enough evidence to suggest that this virus can still be contained,” he told STAT in an interview for a story published Feb. 1, 2020. The world didn’t move swiftly enough to put SARS-CoV-2 “back in the box,” to borrow an expression sometimes used by scientists to describe viral containment. More than 100 million people around the globe have been infected with Covid-19, and more than 2.3 million people have died.
9th Feb 2021 - Stat News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Feb 2021

View this newsletter in full

China's CanSino Coronavirus Vaccine Shows 65.7% Efficacy

CanSino Biologics Inc.’s experimental coronavirus shot has an efficacy rate of 65.7% at preventing symptomatic cases based on an analysis from late-stage trials, making it the latest vaccine candidate to show some protection against Covid-19. The shot co-developed by the Chinese military and the Tianjin-based biotech company proved effective against symptomatic Covid-19, based on a multi-country analysis first posted on Twitter by Faisal Sultan, Pakistan’s health adviser, on Monday. CanSino later forwarded Sultan’s announcement in a statement. The final stage trail included 30,000 participants and was also 90.98% effective in preventing severe disease, Sultan said. A vaccine needs to afford at least a 50% protection rate to be considered effective, as mandated by the world’s leading drug regulators and the World Health Organization.
8th Feb 2021 - Bloomberg

China approves Sinovac's coronavirus vaccine -

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme. More than 31 million doses have been administered, mainly targeting groups at higher infection risks, while a fourth experimental vaccine from CanSino Biologics has been given to military personnel. Brazilian clinical trial results published last month showed the vaccine, dubbed Coronavac, is just over 50% effective.
8th Feb 2021 - pharmaphorum

More medical breakthroughs on the way thanks to BioNTech coronavirus vaccine

Saving the world was, for Dr Katalin Kariko, always a sideline. After a busy year producing the world’s first, and currently most effective, coronavirus vaccine, she is keen to return to the day job. “We have very important projects, and many of them were pushed aside due to the pandemic,” she says. Patients, she adds, are waiting. Those projects — from personalised cancer medicine to curing allergies — have arguably become more important due to what she has done in the past 12 months. Because, today, a lot more people think they will actually work. In January 2020, Kariko was one of the team at BioNTech, a German pharmaceutical company. They had a technology that they thought could make a fast and simple vaccine.
8th Feb 2021 - The Times

Covid: Scientists developing vaccine boosters to tackle variants

Scientists are developing booster jabs to tackle Covid-19 variants, a health minister says, amid concerns about the Oxford-AstraZeneca vaccine's efficacy against the South Africa strain. The vaccine provides good protection against the dominant 'Kent' variant in the UK. But a small study suggests it offers "minimal protection" against mild disease from the South Africa variant. Some 147 cases of this variant have been found in the UK. Health minister Edward Argar said the government was anticipating that an annual jab could be required to combat variants of coronavirus. He also said there was "no evidence" the Oxford-AstraZeneca vaccine was not effective at preventing severe illness from the South African variant, which scientists have warned could become more widespread in the UK.
8th Feb 2021 - BBC News

New variants raise worry about COVID-19 virus reinfections

Evidence is mounting that having COVID-19 may not protect against getting infected again with some of the new variants. People also can get second infections with earlier versions of the coronavirus if they mounted a weak defense the first time, new research suggests. How long immunity lasts from natural infection is one of the big questions in the pandemic. Scientists still think reinfections are fairly rare and usually less serious than initial ones, but recent developments around the world have raised concerns. In South Africa, a vaccine study found new infections with a variant in 2% of people who previously had an earlier version of the virus.
8th Feb 2021 - The Independent

Astra Zeneca and Pfizer Covid-19 vaccines are effective and saving lives says NI Chief Medical Officer

Northern Ireland’s Chief Medical Officer has given his full backing to Northern Ireland’s Covid-19 vaccine programme and said: “They are protecting people from Covid-19 - and saving lives.” Dr Michael McBride was responding to differing reports on the effectiveness of the vaccines, in particular AstraZeneca’s. But he urged people to be confident in the vaccines being rolled out in Northern Ireland right now and urged everyone eligible for the shot, to have it. Dr McBride said: “The AstraZeneca and Pfizer-BioNTech vaccines are protecting people from Covid-19 - and saving lives.
8th Feb 2021 - Belfast Live

Web searches could help detect Covid-19 outbreaks early, study says

Using symptom-related searches through Google could allow experts to predict a peak in cases on average 17 days in advance, a group from University College London (UCL) said. Analysing internet search activity is already used to track and understand the seasonal flu. Using data on Covid-19 web searches in a similar way alongside more established approaches could improve public health surveillance methods. “Adding to previous research that has showcased the utility of online search activity in modelling infectious diseases such as influenza, this study provides a new set of tools that can be used to track Covid-19,” said lead author Dr Vasileios Lampos.
8th Feb 2021 - Aberdeen Evening Express

Cambridge firms underpin game-changing lateral flow test for Covid-19

Two Cambridge-based biotechnology companies have been instrumental in the development of a game-changing platform for lateral flow (LF) tests that could be vital in the fight against Covid-19. Large-scale Covid-19 antibody screenings with high specificity and sensitivity, such as the LF test, could provide public health authorities with reliable data to monitor the impact of regional and national lockdown restrictions and provide evidence of antibody generation after vaccine immunisations. The platform is underpinned by Activotec, a laboratory equipment supplier based in Comberton, while Excivion is developing novel vaccines from St John’s Innovation Centre.
8th Feb 2021 - Cambridge Independent

Vaccines Alone Are Not Enough to Beat COVID

The world’s attention is rightly focused on news of COVID-19 vaccine updates, from eligibility to supply. But we will make a critical error if we ignore the need for treatments as well as vaccines. Vaccines may not reach everyone for many years. Vaccines will not protect everyone. And as infection surges threaten to overwhelm hospitals and nursing homes, immediate remedies are needed. So, it is vitally important we continue to research treatments to limit and cure COVID-19. Consider the flu, which is targeted annually with widely available and effective vaccines. But since no vaccine is perfect, there remains a significant need for flu therapies such as Tamiflu and Relenza because these drugs prevent hospitalizations and save lives. We need Tamiflu-like and Relenza-like drugs for COVID-19.
8th Feb 2021 - Scientific American

COVID-19: Shape-shifting coronavirus is knocking the confidence of scientists

Another half a million or so people will today bare their shoulder and have a vaccine against COVID-19. It's a triumph of science and logistics. But will it end the pandemic? Just a few weeks ago the answer would have been an unqualified "yes". But the evolving virus has knocked the confidence of many scientists.
8th Feb 2021 - Sky News

Scientists to US: Act now to leash virulent COVID variant

The B117 SARS-CoV-2 variant, identified in 33 states thus far, will dominate other strains in the coming weeks, triggering major COVID-19 surges such as those seen in Portugal and the United Kingdom—unless the United States immediately scales up surveillance and mitigation efforts, according to a study published yesterday on the preprint server medRxiv. A team led by scientists from the Scripps Research Institute sequenced SARS-CoV-2 genomes from 10 states using US COVID-19 testing facilities to track the emergence and spread of B117, the more transmissible and lethal variant that was first discovered in the United Kingdom in September and likely introduced to the United States during holiday travel.
8th Feb 2021 - CIDRAP

South Africa pauses AstraZeneca vaccine rollout amid variant COVID questions

South Africa recently received 1 million doses of AstraZeneca-Oxford COVID-19 vaccine and was poised to start vaccinating healthcare workers, but yesterday, health officials announced a pause for the rollout to investigate early findings that it offered little protection against mild-to-moderate disease caused by the B1351 variant strain that's dominant in the country. New questions about the vaccine come as World Health Organization (WHO) advisers this week consider it for emergency use listing, which if approved, would pave the way for lower income countries to receive their first doses though the COVAX program. The first shipments through COVAX depend on 350 million doses of AstraZeneca-Oxford vaccine.
8th Feb 2021 - CIDRAP

Pfizer to nearly halve COVID-19 vaccine production timeline, sterile injectables VP says

With an upsized production goal of 2 billion COVID-19 vaccine doses this year, Pfizer and its German partner BioNTech aren’t resting on their laurels now that their shot, Comirnaty, has emergency nods in the U.S., Europe and beyond. As the companies continue to build out capacity, manufacturing efficiency is getting its own boost, Pfizer revealed. The time it takes the company to produce a COVID-19 vaccine batch could soon be cut from 110 days to an average of just 60, Chaz Calitri, vice president of sterile injectables, told USA Today. “We call this ‘Project Light Speed,’ and it’s called that for a reason,” he said. “Just in the last month, we’ve doubled output.” One element teed up for acceleration is DNA production—the first step in Pfizer’s vaccine manufacturing process, Calitri explained. Making that DNA originally took 16 days, but the process will soon take just nine or 10 days, he said.
8th Feb 2021 - FiercePharma

India's Cadila saddled with more COVID-19 vaccine orders than it can fill

Demand outpacing COVID-19 vaccine supplies has already been a problem for players with authorized products, including Pfizer and AstraZeneca. But an Indian drugmaker known for its generics is reporting similar issues over a shot still kicking around the clinic. Cadila Healthcare, also known as Zydus Cadila, has more orders for its plasmid DNA-based COVID-19 vaccine, ZyCoV-D, than it can make—and so far, it's still on the hunt for partners to hit a production target of 200 million doses, Indian outlet Moneycontrol reports. "We have always believed that this (DNA) platform offers the most safe and efficacious way of handling such a large pandemic and we are very happy to see the strong response we are getting from different countries," Sharvil Patel, managing director of Cadila Healthcare, said, according to Moneycontrol.
8th Feb 2021 - FiercePharma

Covid-19: The E484K mutation and the risks it poses

What do we know about the E484K mutation? The E484K mutation is not a new variant in itself, it’s a mutation which occurs in different variants and has already been found in the South African (B.1.351) and Brazilian (B.1.1.28) variants. The mutation is in the spike protein and appears to have an impact on the body’s immune response and, possibly, vaccine efficacy. On 1 February, Public Health England (PHE) announced that the Covid-19 Genomics (COG-UK) consortium had identified this same E484K mutation in 11 samples carrying the UK variant B.1.1.7 (sometimes called the Kent variant), after analysing 214 159 sequences. Where has it been identified in the UK? PHE confirmed to The BMJ that they have now identified 11 cases of the UK B1.1.7 variant carrying the E484K mutation around the Bristol area and 40 cases of the original SARS-C0V-2 virus carrying the same E484K mutation in the Liverpool area. Public health officials are carrying out enhanced contact tracing, additional laboratory analysis, and testing in these areas. Is this mutation something to worry about? E484K is called an escape mutation because it helps the virus slip past the body’s immune defences. Ravindra Gupta at the University of Cambridge and colleagues have confirmed that the new B.1.1.7 plus E484K variant substantially increases the amount of serum antibody needed to prevent infection of cells.2 We already know that the B.1.1.7 variant is more transmissible so a combination of a faster spreading virus that is also better at evading immunity is worrying—if it isn’t stopped it would outcompete the older B.1.1.7 variant.
5th Feb 2021 - BMJ

AstraZeneca, Oxford race to update COVID-19 vaccine as study flags weak action against variant

It didn’t take long before a morale boost for AstraZeneca’s COVID-19 vaccine was overshadowed by disappointment over its waned protection against a newly emerged coronavirus variant. A new study has found AZ’s COVID-19 shot offered “minimal protection” against mild to moderate disease caused by the B.1.351 variant, which was first identified in South Africa, the University of Oxford, the original developer of the vaccine, said Sunday. The finding has prompted the pair to update their vaccine, dubbed AZD1222, to target variants of the coronavirus with mutations similar to B.1.351. In the meantime, South African authorities have halted rollout of the vaccine as they try to figure out the best way forward.
8th Feb 2021 - FiercePharma

‘What other variants might be out there?’ An expert on viral evolution on what’s happening with coronavirus mutations

Variants” is the latest term to leap from the infectious disease lexicon to the general public as a result of the coronavirus, as the effects of mutations on transmission and vaccines have emerged as top global concerns. But researchers like Emma Hodcroft, a molecular epidemiologist at the University of Bern, have been looking out for genetic changes to the SARS-CoV-2 coronavirus since the beginning of the pandemic. The virus, like any virus, has picked up mutations as it spread, but it’s only been in the past few months that it has been altered in ways that could dramatically shift the dynamics of the Covid-19 pandemic.
8th Feb 2021 - Stat News

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Feb 2021

View this newsletter in full

Oxford vaccine offers ‘limited’ protection against South Africa variant, study finds

AstraZeneca and the University of Oxford have said their vaccine has been found to provide only limited protection against mild and moderate disease caused by the South African variant of Covid-19 in early data from a small trial. However, Oxford vaccine researchers say a version ofthe jab that works against news variants should be available by the autumn. The study, which has not been peer-reviewed, was conducted by South Africa's University of the Witwatersrand and Oxford University. It analysed the E484K mutation in more than 2,000 people, with most of the participants considered young and healthy.
8th Feb 2021 - The Independent

Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase

Pfizer expects to nearly cut in half the amount of time it takes to produce a batch of COVID-19 vaccine from 110 days to an average of 60 as it makes the process more efficient and production is built out, the company told USA TODAY. As the nation revs up its vaccination programs, the increase could help relieve bottlenecks caused by vaccine shortages. "We call this 'Project Light Speed,' and it's called that for a reason," said Chaz Calitri, Pfizer's vice president for operations for sterile injectables, who runs the company's plant in Kalamazoo, Michigan. "Just in the last month we've doubled output."
7th Feb 2021 - USA TODAY on MSN.com

Vaccine strategy needs rethink after resistant variants emerge, say scientists

Leading vaccine scientists are calling for a rethink of the goals of vaccination programmes, saying that herd immunity through vaccination is unlikely to be possible because of the emergence of variants like that in South Africa. The comments came as the University of Oxford and AstraZeneca acknowledged that their vaccine will not protect people against mild to moderate Covid illness caused by the South African variant. The Oxford vaccine is the mainstay of the UK’s immunisation programme and vitally important around the world because of its low cost and ease of use. The findings came from a study involving more than 2,000 people in South Africa. They followed results from two vaccines, from Novavax and Janssen, which were trialled there in recent months and were found to have much reduced protection against the variant – at about 60%. Pfizer/BioNTech and Moderna have also said the variant affects the efficacy of their vaccines, although on the basis of lab studies only.
7th Feb 2021 - The Guardian

Coronavirus Vaccine Nasal Spray Offers Hope To Needle Phobics

While most of the nation pins its hope on the coronavirus vaccine as a route out of the pandemic, Michelle Turner has mixed emotions. As a science teacher in a secondary school, Turner knows she has a rational brain. But put her in the same room as someone holding a needle and she admits all logic goes out the window as she has a total meltdown. “The moment a needle comes anywhere near me, I just flip my lid and start screaming, flinching, swearing and kicking out. It is like an out-of-body experience,” she tells HuffPost UK. Her needle phobia has only got worse with time. ”When I was pregnant with my daughter, it got to the point where the midwife said it was completely unethical to try and take blood from someone who got so distressed,” says Turner, 35, who lives in Barrow-in-Furness, Cumbria.
6th Feb 2021 - HuffPost UK

China Approves Second Coronavirus Vaccine for Public Use

Sinovac Biotech Ltd. received regulatory approval from Chinese authorities for its coronavirus vaccine to be used by the general public in the country’s second such authorization. The conditional approval was announced by the National Medical Products Administration on Saturday. Sinovac earlier said the protective efficacy of its vaccine, CoronaVac, met World Health Organization and China regulatory standards 14 days after the completion of two shots. With the approval, the vaccine can be administered to the general population following one developed by state-owned China National Biotec Group Co. which got permission in December. The Chinese regulator had endorsed CoronaVac for emergency use in July.
6th Feb 2021 - Bloomberg

Could the climate crisis have played a role in the emergence of Covid-19?

Scientists have identified a “possible role” for the climate crisis in the origins of the Covid-19 pandemic. Covid-19 was first recorded in the Chinese city of Wuhan. However, it is not yet clear exactly how the virus emerged. Researchers suspect that the virus initially “spilled over” from bats to humans through an unknown intermediary animal, possibly a pangolin. A study published today finds that changing climate conditions could be linked to a greater diversity of bat species in Yunnan, a province of southwestern China, and its surrounding regions. Early research suggests that the virus causing Covid-19, which is called SARS-CoV-2, could have arisen in this area.
6th Feb 2021 - The Independent

Scientists helping to 'second guess' future mutations of Covid-19 to create new vaccines

Scientists are helping to “second guess” future mutations of coronavirus in order to create new potential vaccines, the chairman of the UK Vaccine Taskforce has said. Asked whether it was possible to produce a vaccine that was comprehensive at tackling new mutations, Clive Dix told BBC Radio 4’s Today: “Yes, absolutely. “The UK is properly at the forefront of surveying all of these variants. “We have actually sequenced nearly 50% of all the virus that has been sequenced in this pandemic at the Sanger centre in Cambridge.
6th Feb 2021 - Wales Online

What's the risk of dying from a fast-spreading COVID-19 variant?

The news is sobering, but complicated. Scientists have released the data behind a British government warning last week that the fast-spreading SARS-CoV-2 variant B.1.1.7 increases the risk of dying from COVID-19 compared with previous variants. But some scientists caution that the latest study — like the government warning — is preliminary and still does not indicate whether the variant is more deadly or is just spreading faster and so reaching greater numbers of vulnerable people. The latest findings are concerning, but to draw conclusions, “more work needs to be done”, says Muge Cevik, a public-health researcher at the University of St Andrews, who is based in Edinburgh, UK.
6th Feb 2021 - Nature

China approves Sinovac Biotech COVID-19 vaccine for general public use

Sinovac Biotech said on Saturday that its unit’s COVID-19 vaccine has been approved for use by the general public by China’s medical products regulator. It marks the second vaccine approved for public use in China, after one developed by a Beijing institute affiliated with state-owned China National Pharmaceutical Group (Sinopharm) was approved in December. Both vaccines, as well as a third candidate from Sinopharm, have already been used in China’s vaccination program which has administered over 31 million doses, mainly targeting groups at higher infection risk. A fourth candidate from CanSino Biologics is being used among military personnel.
6th Feb 2021 - Reuters

COVID-19: Vaccines against new variants should be ready by October

Vaccines specifically designed to tackle new variants of coronavirus should be ready to be rolled out by October, according to the team behind the Oxford University/AstraZeneca jab. Professor Andrew Pollard, director of the Oxford vaccine group, said work on designing a new jab could be a quick process. Studies have shown that variants of COVID-19 that have the E484K mutation could reduce the efficacy of vaccines, but they are still expected to provide good protection against illness and severe disease. The mutation is present in the variant first identified in South Africa, with more than 100 cases of that variant detected in the UK so far. E484K has also been found in Bristol in the variant first recorded in Kent, and in Liverpool in a new variant on the original strain of coronavirus that first came to the UK.
6th Feb 2021 - Sky News

Covid-19: Avoid 'setting dates' for lifting lockdown, scientist warns

The UK government should avoid "setting dates" for when to lift lockdown and instead react to changing circumstances, a scientist has warned. Prof Graham Medley, a member of the Scientific Advisory Group for Emergencies, said leaders should not be "driven by a calendar". Meanwhile, the government has said all over-50s should be vaccinated by May. And a senior Conservative MP has told the BBC that Downing Street should be "looking to open up" society. Sir Graham Brady, who leads the 1922 Committee of Conservative Party backbenchers, cited the falling infection level and success of the vaccine rollout, telling the BBC the situation was "optimistic".
5th Feb 2021 - BBC News

Putin's Once-Scorned Vaccine Is Now a Favorite in Pandemic Fight

President Vladimir Putin’s announcement in August that Russia had cleared the world’s first Covid-19 vaccine for use before it even completed safety trials sparked skepticism worldwide. Now he may reap diplomatic dividends as Russia basks in arguably its biggest scientific breakthrough since the Soviet era. Countries are lining up for supplies of Sputnik V after peer-reviewed results published in The Lancet medical journal this week showed the Russian vaccine protects against the deadly virus about as well as U.S. and European shots, and far more effectively than Chinese rivals.
5th Feb 2021 - Bloomberg

COVID-19: a heavy toll on health-care workers

The COVID-19 pandemic has challenged and, in many cases, exceeded the capacity of hospitals and intensive care units (ICUs) worldwide. Health-care workers have continued to provide care for patients despite exhaustion, personal risk of infection, fear of transmission to family members, illness or death of friends and colleagues, and the loss of many patients. Sadly, health-care workers have also faced many additional—often avoidable—sources of stress and anxiety, and long shifts combined with unprecedented population restrictions, including personal isolation, have affected individuals' ability to cope.
5th Feb 2021 - The Lancet

Moderna sets sights on $200M vaccine factory in Seoul: report

With supply contracts for 50 million COVID-19 vaccine doses in Japan and 40 million in South Korea, Moderna has already made a push into the Asian market. Now, it's laying out plans for a factory all its own in the region. The Cambridge, Massachusetts-based drugmaker is in talks with the South Korean government to invest $200 million into a vaccine production plant in the country, Park Young-sun, a former government minister involved in the plans, told the Asia Business Daily, Reuters reports. Moderna is eager to push into the region, she added.
5th Feb 2021 - FiercePharma

No need 'to start at square one': FDA plans to lay out a speedy path for COVID-19 vaccines, drugs against variants

New coronavirus variants have prompted COVID-19 vaccine makers to start developing updates to their existing offerings. To speed their journey to a pandemic-fatigued public, the FDA says it’s developing expedited review rules for the follow-up shots. The FDA’s working on guidance for the types of data needed to support changes to COVID-19 vaccines. The new rules would provide for “streamlined clinical programs” that can demonstrate an immune response to new variants and “can be executed quickly,” FDA’s acting commissioner, Janet Woodcock, said in a statement Thursday. The draft plan could come in two to three weeks, Politico reported, citing four people familiar with the agency’s internal discussions.
5th Feb 2021 - FiercePharma

Talking Europe - 'Promising' signs for Covid-19 vaccines' efficiency against mutant strains: EMA head

As the EU's 27 member states scramble to contain the spread of new "mutant" strains of the Covid-19 virus, the head of the European Medicines Agency, Emer Cooke, tells FRANCE 24 that there are "promising" results from early studies into how well existing vaccines work against the new variants. The so-called "UK variant", otherwise known as strain B.1.1.7, transmits more easily from person to person and there are predictions that it will become the dominant strain within weeks. EMA Executive Director Emer Cooke says that ongoing preliminary studies look "promising" – and that the EMA has asked vaccine producers to plan studies to prove their results "conclusively". Meanwhile, a growing list of European states are casting doubt on the efficacy, in people aged over 65, of the vaccine developed by Oxford University and AstraZeneca – one of the three authorised vaccines in the EU.
5th Feb 2021 - FRANCE 24

Pfizer withdraws COVID-19 vaccine emergency use bid in India | TheHill

Pfizer has removed its bid for emergency approval of its coronavirus vaccine in India, citing additional information needed by the country’s drug regulator, the pharmaceutical company confirmed to The Hill. The decision, first reported by Reuters on Friday, came after a Wednesday meeting with India’s Central Drugs Standard Control Organization. “Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” Pfizer said in a statement shared with The Hill. The company added that it “will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future.”
5th Feb 2021 - The Hill

Sinovac says COVID-19 vaccine effective in preventing hospitalization, death

China’s Sinovac Biotech on Friday said late-stage trial data of its COVID-19 vaccine from Brazil and Turkey showed it prevented hospitalization and death in COVID-19 patients, but had a much lower efficacy rate in blocking infections. The 12,396-person trial found the CoronaVac vaccine was 100% effective in preventing COVID-19 sufferers from being hospitalized or dying and 83.7% effective in avoiding cases that required any medical treatment, but only 50.65% effective at keeping people from getting infected, according to a statement. The trials evaluated the efficacy of the two-shot vaccine candidate 14 days after inoculation of participants, including healthcare workers who treat COVID-19 patients.
5th Feb 2021 - Reuters

Coronavirus: Irish government 'right' on over 70s vaccine plan

The Irish government has made the "right decision" by not using the Oxford-AstraZeneca Covid-19 vaccine on people aged over 70, an immunologist has said. Prof Kingston Mills from Trinity College Dublin said data was "limited" on its efficacy in the older population. The Irish government said over 70s will receive the Pfizer or Moderna vaccines. However, it has warned the rollout for this age group "may well be slower". On Thursday, Tánaiste (Irish deputy prime minister) Leo Varadkar told the Dáil (Irish parliament) the same number of vaccines will be administered, with a faster rollout for healthcare workers and some other groups who will receive AstraZeneca doses.
5th Feb 2021 - BBC News

UK coronavirus variant found in 74% of Slovak cases; country to open some schools

The UK coronavirus variant, more infectious than the previously dominant strain, has taken over as the main cause of new COVID-19 cases in Slovakia, Prime Minister Igor Matovic said on Friday. The central European country of 5.5 million has struggled to bring down daily cases despite lockdown measures and widespread testing, which is required for people to go out including to work. Hospitals have been strained, with 3,560 coronavirus patients on Thursday. Matovic told a news conference the government had checked all positive samples of PCR laboratory tests taken in the country on Wednesday and results showed 74% were the UK variant, a touch above the 71% in partial findings he had reported earlier on Friday.
5th Feb 2021 - Reuters

Johnson & Johnson asks FDA to authorize its Covid-19 vaccine

Johnson & Johnson officially asked the US Food and Drug Administration for an emergency use authorization of its Covid-19 vaccine Thursday, taking forward the possibility of a third coronavirus vaccine for the US market. "Today's submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic," Dr. Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, said in a statement.
5th Feb 2021 - CNN

COVID-19: Oxford/AstraZeneca vaccine has 'similar effect' against Kent variant, researchers find

The Oxford/AstraZeneca vaccine remains effective against the coronavirus variant first detected in Kent and the South East, researchers have found. The researchers who developed the jab say it has a similar efficacy against the variant compared to the original COVID-19 strain it was tested against. Professor Andrew Pollard, a chief investigator on the Oxford vaccine trial, said the new data suggests "the vaccine not only protects against the original pandemic virus, but also protects against the novel variant, B.1.1.7".
5th Feb 2021 - Sky News

Pregnant women ‘should be included in Covid-19 vaccine trials’

Pregnant women should be included in coronavirus vaccine trials, experts have urged, as those in priority groups wrestle with whether or not to have the jab. Doctors are considering emerging evidence that pregnant women may face greater risks from Covid-19, although they are not at present a priority group. Professor Lucy Chappell, spokeswoman for the Royal College of Obstetricians and Gynaecologists (RCOG), said that it was not asking for this status to change but that it would discuss any risk with the Joint Committee on Vaccination and Immunisation
5th Feb 2021 - The Times

Newsletter Archive

2022

2021

2020

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Nov 2022

New coronavirus at 'particular risk' of jumping to humans discovered in Chinese bats

Blood clot drug totally ineffective as post-Covid treatment, research finds

COVID-19 SeroHub, an online repository of SARS-CoV-2 seroprevalence studies in the United States | Scientific Data

Bivalent Covid Boosters Give Some Protection in CDC Study, But Not Much

Is Covid-19 an Endemic Disease and What Does It Mean for the World?

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Nov 2022

COVID-19 vaccine developed in Thailand can be stored in refrigerator for three months

Over two thirds of first-wave Covid infections led to long Covid, finds study

Safety of the fourth COVID-19 BNT162b2 mRNA (second booster) vaccine: a prospective and retrospective cohort study

Who Is Dying from COVID Now, and Why

Covid Drug Treatments Aren't Keeping Up With Virus Mutations

Novavax Nuvaxovid COVID-19 Vaccine Receives Expanded Authorization in Canada as a Booster in Adults

Job strain and burnout in Spanish nurses during the COVID-19: resilience as a protective factor in a cross-sectional study

Stanford researchers launch first study on long-COVID treatment with Pfizer's Paxlovid

‘We’re not ready’: threat of Covid exit wave stymies China’s reopening

Masks mandated in NSW hospitals as COVID-19 cases rise in Australia's fourth wave

COVID variants BQ.1/BQ.1.1 make up nearly half of U.S. cases - CDC

Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1

Hong Kong Eases Covid Restrictions, Only Requires 2 PCR Testing for Arrivals

Moderna's Omicron shots shows better immune response than original COVID vaccine

China Unveils 20 Measures to Guide Easing of Xi Jinping's Covid Zero Policy

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Nov 2022

COVID-19 and diabetes — where are we now?

COVID vaccines: “We flew the aeroplane while we were still building it”

Africa CDC Saving Lives and Livelihoods Initiative Expands Implementation in Southern Africa – Africa CDC

Africa CDC commends China over partnership in vaccine manufacturing

‘It’s becoming a contortionist’: New COVID-19 subvariants drive wave of infections

Sanofi, GSK score late win with EU COVID booster approval

Three quarters of UK long COVID sufferers working less -survey

Repeat COVID is riskier than first infection, study finds

European regulator recommends Pfizer's Omicron booster for children

Novavax says Omicron shot shows strong immune response as second booster

UK approves Pfizer-BioNTech's COVID booster targeting Omicron BA.4/5

Covid's Drag on the Workforce Proves Persistent. 'It Sets Us Back.'

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Nov 2022

COVID variants BQ.1/BQ.1.1 make up 35% of U.S. cases

U.S. faces pandemic crossroads with Covid deaths still too high and new omicron variants emerging, Fauci says

Sweden against giving EU-approved COVID jab to under-30s

China Agrees to Approve BioNTech's Covid-19 Vaccine for Foreigners, German Chancellor Says

Factbox: What are the new BQ.1 and BQ.1.1 coronavirus variants, and why it matters

UK researchers cure man with persistent Covid for over a year

Could a nose spray a day keep COVID away?

'A silent killer' -- COVID-19 shown to trigger inflammation in the brain

Vaxzevria receives full Marketing Authorisation in the EU for the prevention of COVID-19

Everything You Need to Know About the UK's Covid Booster Plan

China rolls out first inhalable COVID vaccine

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 31st Oct 2022

Scientists identify in humans neutralising antibody to Omicron variants

XBB Symptoms: 10 Nightmare COVID-19 Variant Illness Warning Signs

BQ omicron variant: Will cases spike in the US like they did in Europe?

EU regulator recommends adding heavy periods to side effects of mRNA COVID shots

U.S. government to test Pfizer's Paxlovid for long COVID

Two new Covid strains designated by UK health agency

People who caught mild Covid had increased risk of blood clots, British study finds

Possible RSV, Covid-19 and Flu Collision Has Doctors Worried. What to Know.

Covid’s Heart Effects: Infections Raise Clotting, Death Risks in Large Study

Omicron mutates again: What we know about 3 new subvariants

New Covid Boosters Aren't Better Than Old Ones, Study Finds

COVID disrupted measles vaccinations in Africa and now cases are surging

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Oct 2022

Doctors say Covid symptom has 'disappeared' from most common list as UK infection rates rise again

WHO official warns COVID-19 pandemic "not yet over"

Covid-19 Vaccines Should Be Among Regular Immunizations, CDC Advisers Say

U.S. CDC advisers approve adding COVID shots to vaccine schedules

Omicron subvariants reflect a 'viral evolution on steroids'

FDA Authorizes Novavax Covid-19 Shot as Booster for Adults

Novavax Covid Booster Wins US Emergency Authorization

U.S. FDA authorizes Novavax's COVID vaccine as booster for adults

U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults

Addiction drug shows promise lifting long COVID brain fog, fatigue

Pfizer (PFE) Says Omicron Booster Vaccine Lifts Antibodies Against New Variants

Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Oct 2022

Between rolling natural disasters and COVID, Australia's economy is experiencing a shift from shock to persistent problem

More information sought on Omicron XBB cases among passengers arriving in Hong Kong from Thailand

Scientists identify gene that may generate a higher immune response to Covid vaccine