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Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Jan 2021

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Pfizer coronavirus jab has stopped 50% of infections - NOT just symptoms - Israeli study finds

Israel has given first dose of the Pfizer jab to almost 20 percent of its population Preliminary studies show that the vaccine cuts transmission, not just symptoms Expert warned initial studies not enough to conclude transmissions are stopped Data from hundreds of thousands of people offers extensive view of efficacy But experts have warned that people must stay vigilant despite having first dose Two other studies were also done, with varying results. One found the vaccine cuts infection risk by 60 percent, while another found it was cut by 33 percent Full 95 percent immunity is only achieved when a person is given second dose
14th Jan 2021 - Daily Mail

Future coronavirus vaccines may harness nanoparticles

A nanoparticle-based COVID-19 vaccine may be cheap, safe, and effective. Preclinical study suggests that a single dose of a nanoparticle-based vaccine could provide robust immunity. It may be easier to store and transport than currently available vaccines.
14th Jan 2021 - Medical News Today

Recovering from Covid gives similar level of protection to vaccine

People who recover from coronavirus have a similar level of protection against future infection as those who receive a Covid vaccine – at least for the first five months, research suggests. A Public Health England (PHE) study of more than 20,000 healthcare workers found that immunity acquired from an earlier Covid infection provided 83% protection against reinfection for at least 20 weeks. The findings show that while people are unlikely to become reinfected soon after their first infection, it is possible to catch the virus again and potentially spread it to others. “Overall I think this is good news,” said Prof Susan Hopkins, a senior medical adviser to PHE. “It allows people to feel that prior infection will protect them from future infections, but at the same time it is not complete protection, and therefore they still need to be careful when they are out and about.”
14th Jan 2021 - The Guardian

What should I know about COVID-19 vaccines if I'm pregnant?

What should I know about COVID-19 vaccines if I’m pregnant? Vaccination is likely the best way to prevent COVID-19 in pregnancy, when risks for severe illness and death from the virus are higher than usual. The American College of Obstetricians and Gynecologists says COVID-19 vaccinations should not be withheld from pregnant women and that women should discuss individual risks and benefits with their health care providers. The U.S. government’s emergency authorization for the Pfizer and Moderna vaccines being rolled out for priority groups doesn’t list pregnancy as a reason to withhold the shots.
14th Jan 2021 - The Independent

Blood plasma transfusions with high levels of COVID-19 antibodies reduced the number of patient deaths by 25%, Mayo Clinic study finds

Convalescent plasma infusions can help reduce the number of coronavirus deaths, a new study suggests. Researchers looked at people ill with COVID-19 who received blood plasma from recovered coronavirus patients. When given early enough, patients who received antibody-rich plasma had a one-quarter lower risk of death than those given plasma with low concentrations of COVID-19 antibodies. The team, from the Mayo Clinic, in Rochester, says the treatment could be a stopgap until enough people receive coronavirus vaccines for herd immunity to be achieved.
14th Jan 2021 - Daily Mail on MSN.com

COVID-19: How long are you protected for if you've already had coronavirus - and are you still a risk to others?

People who've had COVID are likely to be protected from reinfection for at least five months and have a similar defence to someone who's been vaccinated, according to a UK study. But does it mean those who have recovered are no longer a risk to others? And could the protection last any longer? Here's what you need to know.
14th Jan 2021 - Sky News

Lancaster scientists developing Covid-19 vaccine nasal spray

The researchers administered two doses of the vaccine via a nasal spray in animal trials which are the first stage in vaccine development. This elicited robust antibodies and T cell responses which were enough to be able to neutralize SARS-CoV-2. There was also a significant reduction in lung pathology, inflammation and clinical disease in the rodents who received the vaccine. The vaccine is based on a common poultry virus called the Newcastle Disease Virus (NDV), which can replicate in humans but is harmless. The scientists engineered NDV to produce the spike proteins of the SARS-CoV-2 virus which causes Covid-19, tricking the body into mounting an immune response against SARS-CoV-2.
14th Jan 2021 - Lancaster Guardian

Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine

After the administration of the first vaccine dose in 805 participants in cohorts 1 and 3 and after the second dose in cohort 1, the most frequent solicited adverse events were fatigue, headache, myalgia, and injection-site pain. The most frequent systemic adverse event was fever. Systemic adverse events were less common in cohort 3 than in cohort 1 and in those who received the low vaccine dose than in those who received the high dose. Reactogenicity was lower after the second dose. Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 224 to 354) and reached 100% by day 57 with a further increase in titers (GMT, 288 to 488), regardless of vaccine dose or age group. Titers remained stable until at least day 71. A second dose provided an increase in the titer by a factor of 2.6 to 2.9 (GMT, 827 to 1266). Spike-binding antibody responses were similar to neutralizing-antibody responses. On day 14, CD4+ T-cell responses were detected in 76 to 83% of the participants in cohort 1 and in 60 to 67% of those in cohort 3, with a clear skewing toward type 1 helper T cells. CD8+ T-cell responses were robust overall but lower in cohort 3.
14th Jan 2021 - nejm.org

Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19

Of the 3082 patients included in this analysis, death within 30 days after plasma transfusion occurred in 115 of 515 patients (22.3%) in the high-titer group, 549 of 2006 patients (27.4%) in the medium-titer group, and 166 of 561 patients (29.6%) in the low-titer group. The association of anti–SARS-CoV-2 antibody levels with the risk of death from Covid-19 was moderated by mechanical ventilation status. A lower risk of death within 30 days in the high-titer group than in the low-titer group was observed among patients who had not received mechanical ventilation before transfusion (relative risk, 0.66; 95% confidence interval [CI], 0.48 to 0.91), and no effect on the risk of death was observed among patients who had received mechanical ventilation (relative risk, 1.02; 95% CI, 0.78 to 1.32).
14th Jan 2021 - nejm.org

The Remaining COVID-19 Journey

I’m sure I wasn’t alone when I breathed a sigh of relief at the much ballyhooed arrival of COVID-19 vaccines at the end of 2020. We’re in the midst of a dark and grief-stricken pandemic winter, and the sooner the vaccine gets us to herd immunity—and, pray, a semblance of normalcy—the better. But the well-worn trope that life is a journey, and not a destination, has an epidemiological application as well. As of this writing, the U.S. just suffered a record-breaking day of thousands of fatalities caused by the novel coronavirus. So in the interim months while most Americans wait their chance to be vaccinated, our goal certainly must be to minimize deaths from COVID-19. In this issue’s cover story, Charles Schmidt takes a comprehensive look at the latest developments in clinical treatments for COVID-19 infection, many of which still need research to bolster their effectiveness
14th Jan 2021 - Scientific American

Past Covid-19 infection may provide 'months of immunity'

Most people who have had Covid-19 are protected from catching it again for at least five months, a study led by Public Health England shows. Past infection was linked to around a 83% lower risk of getting the virus, compared with those who had never had Covid-19, scientists found. But experts warn some people do catch Covid-19 again - and can infect others. And officials stress people should follow the stay-at-home rules - whether or not they have had the virus.
14th Jan 2021 - BBC News

WHO team arrives in China to investigate Covid origins as country sees new case spike

A team of World Health Organization (WHO) researchers have arrived in China to probe the origins of the Covid-19 pandemic - following months of political wrangling with President Xi Jinping’s government. A 10-member team has now landed in Wuhan to conduct a politically sensitive investigation into the origins of the pandemic, amid uncertainty about whether Beijing might try to prevent embarrassing discoveries. Scientists suspect the virus - that has killed 1.9 million people since late 2019 - jumped to humans from bats or other animals, most likely in China’s southwest.
14th Jan 2021 - ITV News

W.H.O. Finally Lands in China to Begin Tracing the Coronavirus

More than a year after a new coronavirus first emerged in China, a team of experts from the World Health Organization arrived on Thursday in the central city of Wuhan to begin hunting for its source. But in a sign of Beijing’s continuing efforts to control the investigation, the team of scientists and W.H.O. employees almost immediately ran into obstacles. Two scientists were unable to enter China at the last minute and remained in Singapore because they had tested positive for coronavirus antibodies, the W.H.O. said on Twitter. The Chinese authorities required the remaining 13 experts to undergo two weeks of quarantine in Wuhan, where the virus first emerged in late 2019.
14th Jan 2021 - The New York Times

J&J’s one-shot Covid vaccine is safe and generates promising immune response in early trial

J&J scientists randomly assigned healthy adults between the ages of 18 and 55 and those 65 and older to receive a high or low dose of its vaccine — called Ad26.COV2.S — or a placebo. Most of the volunteers produced detectable neutralizing antibodies, which researchers believe play an important role in defending cells against the virus, after 28 days, according to the trial data. By day 57, all volunteers had detectable antibodies, regardless of vaccine dose or age group, and remained stable for at least 71 days in the 18-to-55 age group.
14th Jan 2021 - CNBC

Regeneron inks big new coronavirus antibody supply deal worth up to $2.6B

Pharma companies worldwide scrambled to respond to the COVID-19 pandemic early last year, but so far only a few have advanced therapies and vaccines through to the market. Regeneron is one, and now the drugmaker's antibody cocktail could bring a multibillion-dollar windfall in 2021. After previously agreeing to supply the U.S. government with 300,000 doses of its antibody cocktail, Regeneron this week inked a much larger supply deal for up to 1.25 million doses. If the company is able to supply all doses, the deal will come out to $2.63 billion. Under the agreement, the government will pay Regeneron for any doses it’s able to produce by the end of June. The government can also purchase any additional doses past that point at its discretion.
14th Jan 2021 - FiercePharma

Marketing Moderna hitches a ride with Uber to boost vaccine confidence—and, of course, drive access

COVID-19 vaccine maker Moderna is looking for a lift from Uber—a collaboration lift, that is. The two companies say they're planning to work together to promote vaccine confidence and ease access to coronavirus shots. Early ideas include promoting vaccine safety on the Uber network and through in-app messages as well as incorporating Uber rides into the vaccination scheduling process. While those details are still in the works, the appeal of Uber as a partner for Moderna is not only its nationwide network and connections but also the diversity of its 1.2 million drivers. “Uber has broad access across the United States—its ride-sharing platform is used by Americans everywhere, and its drivers represent a wide variety of the population," Michael Mullette, Moderna's vice president of commercial operations in North America, said. "There’s a great opportunity for us to think about educating the population about how do you get immunized … but also how do you access credible information about vaccines."
14th Jan 2021 - FiercePharma

COVID: Turkey launches Chinese vaccine drive despite concerns

Turkish doctors and nurses rolled up their sleeves on Thursday as the nation of 83 million people launched a mass coronavirus vaccination drive with China’s Sinovac jab. Health Minister Fahrettin Koca received the first shot of CoronaVac live on television after formally approving the vaccine on Wednesday despite contradictory data about its efficacy rate. He was followed by Turkish President Recep Tayyip Erdogan, who received the vaccine at a hospital in Ankara, according to state-owned Anadolu news agency. Preliminary studies involving more than 7,000 volunteers in Turkey showed CoronaVac to be 91.25 percent effective. The shot, however, came under scrutiny from regulators after the latest data from Brazil showed it to be just more than 50 percent effective – slightly above the benchmark that the World Health Organization fixed for a vaccine to be effective for general use.
14th Jan 2021 - Al Jazeera English

Johnson & Johnson's COVID-19 vaccine production lags goals as data readout nears: NYT

Amid slower than expected rollouts for the Pfizer and Moderna COVID-19 vaccines in the U.S., Johnson & Johnson’s vaccine could serve as a key boost for the nationwide immunization push. But the pharma giant has fallen behind on its initial manufacturing goals, The New York Times reports, just as its first big data readout looms. Under J&J’s original $1 billion contract with Operation Warp Speed, the company was set to deliver 12 million vaccine doses by the end of February and 100 million by the end of June. Now, sources told the NYT, federal officials have been informed the company is behind its original manufacturing timeline. During a press briefing last week, Operation Warp Speed chief adviser Moncef Slaoui told reporters he thought the company would be able to deliver doses in the “single-digit” millions by the end of February, the NYT reports. J&J was “trying to make that number get as close to a double-digit number as possible, and then a larger number in March and a much larger number in April,” Slaoui added, as quoted by the newspaper.
13th Jan 2021 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Jan 2021

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Johnson & Johnson coronavirus vaccine generates immune response, few side effects, in early trials

Early stage trials of Johnson & Johnson's experimental coronavirus vaccine show it generated an immune response in nearly all volunteers, with minimal side-effects, after a single dose. The company expects to report details of more advanced trials later this month and is hoping to apply for authorization from the US Food and Drug Administration soon after. Researchers who tested the vaccine in a combined Phase 1-2 trial -- mostly meant to show safety -- found either one or two doses of the vaccine generated both antibody and T-cell responses against the coronavirus. The trials were not designed to show whether the vaccine protected people against either infection or symptoms of coronavirus -- that's what the ongoing Phase 3 trials are designed to do. Writing in the New England Journal of Medicine, an international team of researchers who tested the vaccine in around 800 volunteers said the early stage trials showed it was safe and probably should work.
13th Jan 2021 - CNN International

COVID-19 infection gives some immunity for at least five months, UK study finds

People who have had COVID-19 are highly likely to have immunity to it for at least five months but there is evidence that those with antibodies may still be able to carry and spread the virus, a UK study of healthcare workers has found. Preliminary findings by scientists at Public Health England (PHE) showed that reinfections in people who have COVID-19 antibodies from a past infection are rare - with only 44 cases found among 6,614 previously infected people in the study. But experts cautioned that the findings mean people who contracted the disease in the first wave of the pandemic in the early months of 2020 may now be vulnerable to catching it again. They also warned that people with so-called “natural immunity” - acquired through having had the infection - may still be able carry the SARS-CoV-2 coronavirus in their nose and throat, and could unwittingly pass it on.
14th Jan 2021 - Reuters

JPM: How did Pfizer up its COVID-19 vaccine capacity? 'Out of the box manufacturing,' CEO says

Pfizer partner BioNTech upped the pair’s 2021 COVID-19 output projection to 2 billion doses for 2021, up from a previous estimate of up from a previous estimate of 1.3 billion But how will the companies get there?
13th Jan 2021 - FiercePharma

COVID-19 vaccine dosing schedules should be adhered to, say stakeholders

In a collective flexing of muscles over the controversy of how and when to dose the new COVID-19 vaccines now appearing on global markets, the leading pharma and vaccine lobbying bodies have come out strongly in favor of using the products as indicated by manufacturers and the various medicine regulators that have approved their use, which so far has largely been on a conditional/emergency basis. In a joint statement issue this afternoon, the biopharmaceutical industry said it acknowledges the considerable challenges governments are facing to urgently address the enormous strain the pandemic is placing on healthcare systems, societies and economies. In light of the urgent need to reach as many people as possible with COVID-19 vaccines, there are emerging discussions regarding dosing strategies that may not be supported by the authorized labelling or published clinical data.
13th Jan 2021 - The Pharma Letter

J&J likely to seek EU approval for COVID-19 vaccine in February: lawmaker

Johnson & Johnson could deliver the first doses of its COVID-19 vaccine to Europe in April, an EU official told Reuters on Wednesday after a top lawmaker said the U.S. healthcare company was likely to seek EU regulatory approval in February. Clinical data on the vaccine has been assessed by the European Medicines Agency (EMA) since Dec. 1 under a rolling review to speed up possible approval. A senior EU official, who is involved in negotiations with vaccine makers and spoke on condition of anonymity, said the J&J shot could be available from April 1 in Europe. Earlier on Wednesday, an EU lawmaker said J&J could seek EU approval for its one-shot vaccine in February.
13th Jan 2021 - Reuters

Johnson & Johnson Expects Covid Vaccine Results Soon but Lags in Production

Johnson & Johnson expects to release critical results from its Covid-19 vaccine trial in as little as two weeks — a potential boon in the effort to protect Americans from the coronavirus — but most likely won’t be able to provide as many doses this spring as it promised the federal government because of unanticipated manufacturing delays. If the vaccine can strongly protect people against Covid-19, as some outside scientists expect, it would offer big advantages over the two vaccines authorized in the United States. Unlike those products, which require two doses, Johnson & Johnson’s could need just one, greatly simplifying logistics for local health departments and clinics struggling to get shots in arms. What’s more, its vaccine can stay stable in a refrigerator for months, whereas the others have to be frozen.
13th Jan 2021 - The New York Times

J&J COVID-19 vaccine on track for March rollout, still aims for 1 billion doses this year: executive

Johnson & Johnson is on track to roll out its single-shot coronavirus vaccine in March, and expects to have clear data on how effective it is by the end of this month or early February, the U.S. healthcare company's chief scientific officer said. Dr. Paul Stoffels in an interview on Tuesday also said J&J expects to meet its stated target of delivering 1 billion doses of its vaccine by the end of this year as the company ramps up production. Stoffels said it was premature to say how many doses would be available in March, presuming the company receives emergency authorization from the U.S. Food and Drug Administration. The New York Times reported earlier on Wednesday that J&J was experiencing manufacturing delays that would reduce the number of doses on hand initially.
13th Jan 2021 - Reuters on MSN.com

Stricter COVID-19 restrictions likely saved THOUSANDS of lives in European countries, study finds

European countries that had stricter mitigation measures against COVID-19 likely saved thousands of lives, a new study finds. Nations such as Serbia, Croatia and Bosnia and Herzegovina had closed schools and offices, limited gatherings and implemented stay-at-home orders before cases began rapidly spreading across the continent, the Centers of Disease Control and Prevention (CDC) revealed on Tuesday. Meanwhile countries such as the UK, Belarus and Luxembourg implanted few to no restrictions, allowing infections to spread relatively unchecked. What's more, the CDC found that sterner restrictions in most European countries could have led at least 74,000 fewer deaths - mostly in the UK, France and Spain.
13th Jan 2021 - Daily Mail

Sinovac: Brazil results show Chinese vaccine 50.4% effective

A coronavirus vaccine developed by China's Sinovac has been found to be 50.4% effective in Brazilian clinical trials, according to the latest results released by researchers. It shows the vaccine is significantly less effective than previous data suggested - barely over the 50% needed for regulatory approval. The Chinese vaccine is one of two that the Brazilian government has lined up. Brazil has been one of the countries worst affected by Covid-19. Sinovac, a Beijing-based biopharmaceutical company, is behind CoronaVac, an inactivated vaccine. It works by using killed viral particles to expose the body's immune system to the virus without risking a serious disease response.
13th Jan 2021 - BBC News

Are women with asthma at increased risk for severe COVID-19?

Although adults with asthma appear to have a reduced risk of severe COVID-19 compared with younger populations,1 women with asthma might represent a somewhat susceptible subgroup for severe COVID-19 requiring hospitalisation.2 A study by Atkins and colleagues established female sex as an independent risk factor for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) hospitalisation among patients with asthma in the UK.2 This study and three additional studies from Paris, France, Illinois, USA, and New York, NY, USA, report that 37–53% of all individuals hospitalised with SARS-CoV-2 were women.3, 4, 5 However, 56–71% of patients with asthma hospitalised for COVID-19 were women in these studies
13th Jan 2021 - The Lancet

Coronavirus UK: Lockdown is creating 'unprecedented' mental illness pandemic, experts warn

Mental health charity Mind's daily website views rose from 9,580 to 14,167. Its chief executive Paul Farmer warned there was a 'mental health pandemic.' YoungMinds' parents helpline has received calls about anxiety and depression. Britain was plunged into a third national lockdown by Boris Johnson last week
13th Jan 2021 - Daily Mail

COVID-19: Study suggests almost half of ICU staff have turned to alcohol or had suicidal thoughts

Almost half of intensive care workers have turned to alcohol or had suicidal thoughts during the coronavirus pandemic, a new study suggests. The research shows that 45% of ICU staff polled met the clinical threshold for at least one of the following: post-traumatic stress disorder (PTSD), severe anxiety or depression and problem drinking. One in eight (13%) said they had experienced frequent thoughts of "being better off dead" or hurting themselves within the past two weeks. The study, published in the Occupational Medicine journal, surveyed 709 healthcare workers from nine intensive care wards across England in June and July 2020, but has not yet been peer reviewed.
13th Jan 2021 - Sky News

AstraZeneca boss says two million weekly doses of vaccine will be delivered to NHS ‘imminently’

Two million doses of the Oxford/AstraZeneca jabs will “imminently” be delivered to the NHS a week as the vaccine roll-out is dramatically stepped up, a pharmaceutical boss said today. Tom Keith-Roach, president at AstraZeneca UK, said 1.1 million doses of the company’s Covid-19 jab had been released to date. He told the Commons science and technology committee: “We are scaling up very rapidly and this will happen imminently to releasing two million doses a week. “We’re absolutely on track to do that and therefore deliver tens of millions of doses in the first quarter of the year.
13th Jan 2021 - Evening Standard

German COVID-19 study finds concert halls are safe ‘at half capacity’

A German concert hall commissioned a study which found that – with the correct ventilation system – arts venues are theoretically ‘covid-safe’ at half audience capacity. Concert hall closures have been a heavy blow for musicians in Germany, the UK and in all countries shaken by the coronavirus pandemic. And while there has been government aid, it has rarely been enough to offset lost income from cancelled gigs. In the wake of ongoing closures in its region, in north Germany, the Dortmund Concert Hall decided to commission a study from scientific research organisation, the Fraunhofer Society, to investigate the spatial spread of aerosols and CO2 in a music venue. The study looks specifically at the risk of infection for audience members when attending concert halls and theatres.
12th Jan 2021 - Classic FM


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 13th Jan 2021

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Australia's chief medical officer defends AstraZeneca's Covid vaccine amid efficacy concerns

Australia’s chief medical officer Professor Paul Kelly and infectious diseases experts have defended securing 54m doses of a Covid-19 vaccine made by Oxford University and pharmaceutical company AstraZeneca, amid concerns the vaccine will not be effective enough to achieve herd immunity. The president of the Australian and New Zealand Society for Immunology, Prof Stephen Turner, told Nine media that Australia should halt the AstraZeneca vaccine rollout because it has “lower efficacy”. “You cannot rely on it to establish herd immunity,” he said. The head of the Western Australian branch of the Australian Medical Association, Dr Andrew Miller, who is an anaesthetist, echoed the comments to the Australian, saying: “We need to pause and look at what the outcomes are going to be before we take any further steps.”
13th Jan 2021 - The Guardian

Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. Approvals for injectable vaccines for COVID-19 are starting to build, but non-injectables like oral and intranasal vaccines could be required if the pandemic is to be fought across all areas of the globe, according to Wayne Channon, the UK firm’s chairman. “Non-injectables remove the need for health professional-led immunisation programmes, making widespread vaccine roll-outs quicker and easier and more affordable,” Channon told pharmaphorum.
12th Jan 2021 - pharmaphorum.com

How can countries stretch COVID vaccine supplies? Scientists are divided over dosing strategies

Amid skyrocketing coronavirus infections, some countries are attempting to stretch limited supplies of COVID-19 vaccines by reducing doses or changing vaccination schedules from those shown to be effective in clinical trials. But data are scarce on the impact of such measures, and scientists are split over whether they are worth the risks. “It might be fine,” says virologist Dan Barouch at Harvard Medical School in Boston, Massachusetts. “But we should stick with what’s been proven to work, because we want it to work. We don’t want to be creative for some unclear benefit and then have an unexpected problem.”
12th Jan 2021 - Nature.com

A simple Fitbit could detect Covid-19 days before symptoms appear

A Fitbit device may be able to give its wearer an early warning over a coronavirus infection before symptoms begin to appear. That’s the thesis from a group of researchers at Stanford University who are currently studying whether wearable technology could help fight the pandemic. Modern Fitbit devices (as well as similar gadgets made by Apple and Garmin) track heart rates and could indicate abnormalities that show up after infection. Although a Covid-19 victim may not show obvious symptoms – such as a cough or loss of smell – for up to five days there is a ‘presymptomatic’ period. During this phase, their body may give off signals that suggest they caught the virus.
12th Jan 2021 - Metro

Scientists try to understand COVID-19 variant

The coronavirus is changing and taking on new characteristics that can make it harder to fight. New variants found in South Africa and the UK are more contagious, and it's unclear if they are more deadly.
12th Jan 2021 - Deutsche Welle

Pfizer Says It Can Quickly Develop Vaccines for Covid-19 Variants

The Big Pharma company Pfizer is digging in for a long fight against Covid-19. In an interview on Tuesday morning, the company’s chief scientific officer, Mikael Dolsten, said that Pfizer (ticker: PFE) is working on a more stable formulation of its Covid-19 vaccine that will be easier to distribute, and is thinking through how to update the vaccine if new strains of the virus emerge that evade the current version. Dolsten said that the Covid-19 problem, and the problem of new coronaviruses in general, isn’t going away.
12th Jan 2021 - Barron's

Bacteria in your GUT 'affects Covid-19 severity'

South Korean study reviewed pre-existing research on role of gut microbiome Hong Kong-based scientists examined blood and stool samples from patients Both studies indicate a gut microbe imbalance is key in severe Covid-19
12th Jan 2021 - Daily Mail

Japan's Chugai soars nearly 6% after UK says its drug reduces hospital time for Covid patients

The U.K. government said patients receiving the drugs, typically used to treat rheumatoid arthritis, “left intensive care between 7 to 10 days earlier on average.” A government-funded clinical trial showed tocilizumab was among two drugs that “reduced the relative risk of death by 24% when administered to patients within 24 hours of entering intensive care.” Shares of Chugai closed 5.91% higher on Tuesday. Earlier in the session, Chugai’s stock soared as much as 16.26%.
12th Jan 2021 - CNBC

WHO experts to visit Wuhan in Covid-19 origins probe, says China

World Health Organisation experts will visit the city of Wuhan, where the coronavirus was first detected in late 2019, at the start of their investigation into the origins of the pandemic, China has said. Foreign Ministry spokesperson Zhao Lijian said the experts will arrive in Wuhan on Thursday. Other details of their schedule have not been announced and the central government's National Health Commission offered no further information. The visit has been expected for months. WHO chief Tedros Adhanom Ghebreyesus expressed frustration last week that arrangements were taking so long to finalise.
12th Jan 2021 - The Irish News

Third time's the charm? Brazil scales back efficacy claims for COVID-19 vaccine from China

A more detailed analysis that included trial participants who tested positive but had symptoms so mild they did not seek help found 167 cases of COVID-19 in the placebo group and 85 in people who received the vaccine, for an estimated efficacy of 50.34%. Even allowing for statistical uncertainties, that is considerably below the greater than 90% efficacies of three other already authorized COVID-19 vaccines. But Esper Kallas, a study investigator based at the University of São Paulo’s main campus who spoke at the press conference, notes that because definitions of a positive case have varied among trials, “There may not be an accurate comparability between the studies.” In the Brazil trial, the liberal definition of a case “put things to the most difficult test,” said Ricardo Palácios of Butantan, who served as the clinical director of the study. “It is like comparing someone who runs a kilometer on paved ground versus someone running 1 kilometer with obstacles.”
12th Jan 2021 - Science Magazine

US child COVID hospital rates vary widely by state, time

Rates of pediatric COVID-19 hospitalizations have varied dramatically across US states and more than tripled from May to November, raising concerns that specialized medical resources for children may not be available at the time and place they are needed, according to a research letter published yesterday in JAMA Pediatrics. A team led by researchers from the University of Minnesota in Minneapolis used state-level hospitalization data and US Census information to assess COVID-19 hospitalization trends among patients 19 years and younger in 22 states. From May 15 to Nov 15, 2020, a total of 301,102 Americans were hospitalized with COVID-19, 5,364 of them children. In mid-May, the average cumulative hospitalization rate per 100,000 children was 2.0, which increased to 7.2 by mid-November.
12th Jan 2021 - CIDRAP

Fierce JPM Week: Will the first COVID-19 vaccines deter future launches? Not at all, experts say

Typically in drug and vaccine development, first-to-market products command a big advantage that can deter follow-up products. Not so with COVID-19 vaccines, experts said Tuesday. There’s still plenty of need for new entrants. Even as the first COVID-19 vaccines from Pfizer-BioNTech, Moderna and AstraZeneca are deploying in the U.S. and other countries, more programs will need to succeed to vaccinate the entire world, Swati Gupta, Ph.D., vice president and head of emerging infectious diseases and scientific strategy at IAVI, said on a Fierce JPM Week panel. IAVI, a nonprofit research group, is partnered with Merck & Co. on an early-stage candidate based on the same technology used in Merck's Ebola vaccine. The ongoing COVID-19 vaccine launches will hopefully “help us to end the acute phase of the pandemic,” Gupta said, but, because COVID-19 is likely to become endemic, “we also need to plan for longer-term management of the disease.”
12th Jan 2021 - Fierce Pharma

JPM: Gilead's Veklury, now used in half of hospitalized U.S. COVID-19 patients, delivers multibillion-dollar revenue bump

Gilead Sciences unveiled a surprise Monday: It enjoyed a bigger-than-expected sales boost from COVID-19 therapy Veklury, better known as remdesivir. But what changed since October, when Gilead last predicted 2020 sales? Hospitalizations are up fourfold, for one—and Veklury use is way up, too. “One in two patients hospitalized now is treated with Veklury in the United States,” CEO Dan O’Day said during Gilead’s Monday presentation at the annual J.P. Morgan healthcare conference, noting that Veklury use in hospitalized COVID-19 patients is up from 30% in October to around 50% to 60% today.
12th Jan 2021 - FiercePharma

JPM: 'Very soon,' says Johnson & Johnson CEO as world waits for its COVID-19 vaccine data

Johnson & Johnson's one-dose COVID-19 vaccine regimen could jump-start an immunization push that's faltering in spite of the millions of doses Pfizer, BioNTech, AstraZeneca and Moderna are rolling out around the world. And the J&J shot is on the verge of its next big step forward. The pharma giant is in the “final stages” of data analysis for its phase 3 trial, CEO Alex Gorsky said Monday at the annual J.P. Morgan healthcare conference. The company hopes “to have that information very soon,” he added.
12th Jan 2021 - FiercePharma

JPM: Regeneron execs say 'it's a problem' how few COVID-19 patients are getting antibody treatments

To Regeneron, there’s no question about it: “We as a society have to do a much better job” of getting antibody therapies—such as the company’s own—to patients, R&D chief George Yancopoulos said Monday at the J.P. Morgan Healthcare Conference. Like Eli Lilly’s single-antibody treatment, Regeneron’s antibody cocktail bears an emergency use authorization in mild-to-moderate COVID-19 patients at least 12 years of age who aren't hospitalized but are at high risk of progressing to severe COVID-19. But while the treatments are available, they’re not seeing anywhere near the level of use they would be if all eligible patients were receiving them. And “it’s a problem,” Yancopoulos said. “Every day, there are hundreds of thousands of people getting infected that fit the profile where they could benefit from the antibody therapies. They could slow down very significantly the progression of these people into hospitals and into more severe states.
12th Jan 2021 - Fierce Pharma

Immunological characteristics govern the transition of COVID-19 to endemicity

We are currently faced with the question of how the CoV-2 severity may change in the years ahead. Our analysis of immunological and epidemiological data on endemic human coronaviruses (HCoVs) shows that infection-blocking immunity wanes rapidly, but disease-reducing immunity is long-lived. Our model, incorporating these components of immunity, recapitulates both the current severity of CoV-2 and the benign nature of HCoVs, suggesting that once the endemic phase is reached and primary exposure is in childhood, CoV-2 may be no more virulent than the common cold. We predict a different outcome for an emergent coronavirus that causes severe disease in children. These results reinforce the importance of behavioral containment during pandemic vaccine rollout, while prompting us to evaluate scenarios for continuing vaccination in the endemic phase.
11th Jan 2021 - Science Mag

Japan has found a new Covid variant. Here's how it compares to virus strains in the UK, South Africa

The identification of a new Covid variant comes as countries scramble to contain two other contagious strains that have emerged in the U.K. and South Africa. Public health experts have expressed concern the fresh strains could pose a threat to inoculation efforts. In recent weeks, optimism about the mass rollout of coronavirus vaccines appears to have been tempered by the resurgent rate of virus spread worldwide.
11th Jan 2021 - CNBC


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 12th Jan 2021

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Moderna says COVID-19 vaccine immunity to stay at least a year

Immunity from Moderna Inc’s COVID-19 vaccine should last at least a year, the company said on Monday at the J.P. Morgan Healthcare conference. The drugmaker said it was confident that the messenger RNA (mRNA) technology it used was well suited to deploy a vaccine based on the new variant of the coronavirus which has emerged in a handful of countries. The company’s vaccine, mRNA-1273, uses synthetic mRNA to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. Moderna said in December it would run tests to confirm the vaccine's activity against any strain.
12th Jan 2021 - Reuters on MSN.com

Vaccine makers prepare for game of Covid cat and mouse

Vaccine makers and medicine regulators are sketching out plans in case the mutating coronavirus turns vaccine development into a game of cat and mouse. Just weeks after leading manufacturers secured the first regulatory approvals, mutations in the virus have forced scientists to re-test their Covid-19 vaccines and prepare to tweak their formula should the shots prove less effective. At the same time, regulators are considering how they could fast-track new approvals and whether they could use the seasonal flu jab as a model to authorise revised versions without requiring long trials.
11th Jan 2021 - Financial Times

MEPs to view CureVac coronavirus vaccine contract on Tuesday

MEPs will be able to see the CureVac vaccine contract starting Tuesday, Health Commissioner Stella Kyriakides tweeted Monday. "Transparency & accountability are core EU values," she wrote, adding that she has been working with companies to make more information public: "More companies should follow this example." For months, the European Parliament has called for more transparency with the Commission's classified vaccine deals, while the Commission has countered it's up to the companies to release confidential information.
11th Jan 2021 - POLITICO.eu

BioNTech aims for 2 billion COVID-19 vaccine doses in 2021

Pfizer Inc’s partner BioNTech SE has boosted the 2021 delivery target for their COVID-19 vaccine to 2 billion doses, up from 1.3 billion previously, as they add new production lines and as more doses can be extracted per vial. Special syringes known as low dead space syringes allow for extraction of six vaccine doses from a standard vial, instead of the usual five, avoiding wasting unused liquid left in a syringe. That would result in 1 billion people getting the designated two-dose regimen, BioNTech said on Monday in a presentation for the annual JP Morgan healthcare conference being held virtually this year due to the coronavirus pandemic.
11th Jan 2021 - Reuters

Urgent call for 'lifesaving' blood donations from Scots recovered from Covid-19 to treat other patients

The plasma in the blood of those recently recovered from the virus contains antibodies which could save the life of another person. Those giving the donation must have been free of symptoms for four weeks, and feel completely fit and well. They are also asked to get in touch withing four months of recovery, as antibody levels reduce after that. The “convalescent plasma”, as it is known, will be used to treat patients in a major Covid-19 treatment trial called “RECOVERY”. If successful the treatment will be rolled out to hospitals across Scotland.
11th Jan 2021 - The Scotsman on MSN.com

Which US demographics are more likely to refuse a COVID-19 vaccine?

A new survey indicates that over 31% of individuals queried had no intention of getting vaccinated against infection with SARS-CoV-2. According to the same source, the groups most likely to reject a COVID-19 vaccine are Black people, women, and those with conservative political leanings. The researchers who led the survey emphasize that policymakers must find better ways of communicating with and reassuring the public about the effectiveness and safety of COVID-19 vaccines.
11th Jan 2021 - Medical News Today

India's quick nod to homegrown COVID-19 vaccine seeds doubt

As the director of a large hospital in the Indian state that has seen the country’s most coronavirus cases, Dr. S.P. Kalantri had been waiting for the day a vaccine would be approved and bring protection not only to his community but also himself. But now he has his doubts about getting the shots after India took a regulatory shortcut to approve a vaccine by Indian drugmaker Bharat Biotech before late clinical trials showed it was effective in preventing illness from coronavirus infections. “I’d rather wait and watch,” said Kalantri, who runs a hospital in Maharashtra state’s Wardha district.
11th Jan 2021 - Associated Press

Can you spread Covid-19 if you get the vaccine?

We know that the vaccines now available across the world will protect their recipients from getting sick with Covid-19. But while each vaccine authorized for public use can prevent well over 50% of cases (in Pfizer-BioNTech and Moderna‘s case, more than 90%), what we don’t know is whether they’ll also curb transmission of the SARS-CoV-2 virus. That question is answerable, though—and understanding vaccines’ effect on transmission will help determine when things can go back to whatever our new normal looks like.
11th Jan 2021 - Quartz

China's Efforts to Hide Covid Missteps in Wuhan

At a museum in Wuhan, China, a sprawling exhibition paints a stirring tale of how the city’s sacrifices in a brutal 76-day lockdown led to triumph over the coronavirus and, ultimately, rebirth. No costs appear to have been spared for the show, which features a hologram of medical staff members moving around a hospital room, heart-rending letters from frontline health workers and a replica of a mass quarantine site, complete with beds, miniature Chinese flags and toothbrush cups. But the exhibition is also striking for what is not included. There is no mention of the whistle-blowing role of Ai Fen, one of the first doctors to sound the alarm in Wuhan, where the virus is believed to have originated, or the decision by Zhang Yongzhen, a Shanghai doctor, to share its genome with the world against official orders.
11th Jan 2021 - The New York Times

COVID-19 tracker: BioNTech aims for 2B shot doses in 2021; It's time for the U.S. to 'reset' its vaccine rollout, Gottlieb says

Novavax tapped Baxter BioPharma Solutions to crank out its late-stage vaccine for European and British markets as Moderna started delivering its vaccine to the continent. Meanwhile, Merck KGaA bought out German mRNA manufacturer AmpTec as it looks to expand in the fast-growing field. Twenty-two Publix pharmacies will start offering pandemic shots in Florida.
11th Jan 2021 - FiercePharma

JPM: BioNTech hikes COVID-19 vaccine output to 2B doses in 2021—and plans a bigger label, too

With its Pfizer-partnered COVID-19 vaccine authorized in the U.S., Europe, the U.K. and a slate of other countries, German mRNA specialist BioNTech is wasting no time scaling up its 2021 pandemic ambitions—namely, 2 billion shots by year-end, plus a slate of new approvals and a temperature-stable formulation, too. BioNTech set its sights on producing 2 billion doses of its pandemic vaccine, now dubbed Comirnaty, this year, up from a previous estimate of 1.3 billion, CEO Uğur Şahin said at the virtual J.P. Morgan Healthcare Conference. That production boost will rely on six global manufacturing sites tapped in Pfizer and BioNTech’s alliance, including a facility in Marburg, Germany, that's expected to go live by the end of February, the company said. Besides tapping that site, which will have a 75 million-dose capacity, the company plans to call on new suppliers and CMOs, Sahin said.
11th Jan 2021 - FiercePharma

People with type 1 diabetes have a higher risk of dying from Covid-19. Why are they lower on CDC’s vaccine priority list?

Laura Woerner has diligently managed her type 1 diabetes since she was diagnosed at age 11. She’s remained vigilant about anything that might throw her blood sugar levels out of balance, and now, at 36, she has had two healthy pregnancies and avoided such severe complications of diabetes as limb neuropathy or eye disease. Woerner knows what she needs to do to maintain her health. What she doesn’t know is why the nation’s leading public health authority places people like her farther down the priority list for receiving Covid-19 vaccination than people with type 2 diabetes. As written now, the guidelines put her in with the rest of the U.S. population under age 65, despite research showing that people with type 1 diabetes are at just as high a risk of dying from Covid-19 as those with type 2, if not higher.
11th Jan 2021 - Stat News

States and hospitals: overhaul your vaccine plans with data before it’s too late

The first phase of the vaccine rollout, which is supposed to deliver shots to roughly 24 million health care workers and residents of long-term care facilities, has been stymied by poorly conceived distribution plans based on judgement calls. Without better use of sound science and data, vaccine plans for the next two phases of the rollout, which aim to inoculate nearly 180 million Americans, could descend into complete chaos. Most of the missteps so far stem from the same problem: prioritization decisions that ignore the science of risk assessment and leave too much to chance. From Stanford Medical Center’s reliance on a simplistic and arbitrary distribution plan that kicked front-line health care workers to the back of the line, to Massachusetts General Hospital’s use of an app that relied on workers to self-report their level of risk, to an Arizona county’s misplaced trust in a survey issued to health care workers, we’ve seen that the people who need the vaccine the most tend to get left behind when allocation decisions are made by faulty risk models or are up to the discretion of a handful of individuals, despite their best intentions.
11th Jan 2021 - Stat News

Covid research: Convalescent plasma trial paused as results poor

Scientists running REMAP-CAP trial have stopped enrolling Covid ICU patients Found 'no evidence' convalescent plasma therapy boosted their survival chance Will continue to test the antibody-rich plasma on people with moderate illness
11th Jan 2021 - Daily Mail


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Jan 2021

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Hong Kong fourth wave: sewage tests for coronavirus to be expanded, aim for ‘gold standard’

Pilot scheme by HKU experts helped uncover nine infections in two blocks. Mandatory testing will be triggered if sewage checks reveal two consecutive positive results or two positives over three days
10th Jan 2021 - South China Morning Post

New mutant strain of coronavirus is discovered in Japan

Unseen strain found in Japan after plane passengers tested positive. Four men and women, in their teens to 40s, were found to have the new strain. They had arrived at Haneda Airport in Tokyo from Brazil on Saturday, January 2. Japan's health and welfare department has reported the new discovery to WHO
10th Jan 2021 - Daily Mail

Jordan approves emergency use of China’s Sinopharm coronavirus vaccine

The country hopes to start its vaccination campaign in the coming days, with around 200,000 people having registered for inoculation. China’s Sinopharm says its vaccine is 79 per cent effective
9th Jan 2021 - South China Morning Post

WHO-led COVAX initiative secures contracts of 2 bln doses of COVID-19 vaccines: Tedros

COVAX, an international initiative for COVID-19 vaccines led by the World Health Organization (WHO), has secured contracts of 2 billion doses of vaccines, WHO Director-General Tedros Adhanom Ghebreyesus said on Friday.
9th Jan 2021 - The Star

Meet the Black female scientist at the forefront of COVID-19 vaccine development

When President Donald Trump paid a visit to the National Institutes of Health last March, the leads at the vaccine research center explained their life-saving mission. The key to that mission was a 34-year-old doctor named Dr. Kizzmekia Corbett. "I was just there telling the task force about the work that we've been doing," Corbett told "CBS This Morning: Saturday" co-host Michelle Miller. Two weeks after the visit, Corbett's team began the first stage of clinical trials. She said they took a lot of the knowledge they have gained in the last six years and applied it to a vaccine platform in collaboration with Moderna. The vaccine rolled out 10 months later. "The vaccine teaches the body how to fend off a virus, because it teaches the body how to look for the virus by basically just showing the body the spike protein of the virus" she explained. "The body then says 'Oh, we've seen this protein before. Let's go fight against it.' That's how it works."
9th Jan 2021 - CBS News

Covid-19: Breastfeeding women can have vaccine after guidance turnaround

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has revised its guidance so that pregnant and breastfeeding women can receive the covid-19 vaccine. Writing in BMJ Opinion, Helen Hare, an acute medicine trainee, and Kate Womersley, an academic foundation trainee, said that the change had come after strong pressure from campaigners, clinicians, and some of the women affected. The MHRA had previously recommended that breastfeeding women should not be given the vaccine, which Hare and Womersley said had been interpreted by NHS trusts as a blanket ban. But on 30 December the agency said that women who were breastfeeding could be given both the Pfizer-BioNTech vaccine and the Oxford-AstraZeneca vaccine
9th Jan 2021 - The BMJ

As Coronavirus Mutates, the World Stumbles Again to Respond

Doctors and nurses at a South African hospital group noticed an odd spike in the number of Covid-19 patients in their wards in late October. The government had slackened its lockdown grip, and springtime had brought more parties. But the numbers were growing too quickly to easily explain, prompting a distressing question. “Is this a different strain?” one hospital official asked in a group email in early November, raising the possibility that the virus had developed a dangerous mutation. That question touched off a high-stakes genetic investigation that began here in Durban on the Indian Ocean, tipped off researchers in Britain and is now taking place around the world. Scientists have discovered worrisome new variants of the virus, leading to border closures, quarantines and lockdowns, and dousing some of the enthusiasm that arrived with the vaccines.
9th Jan 2021 - New York Times

Another COVID-19 strain? White House warns of 'USA variant' of coronavirus

The White House task force for coronavirus has warned of a USA variant of COVID-19 that could be fuelling the already aggressive spread of the virus. This variant, the task force pointed out, is separate from the UK coronavirus variant that is touted to be 70 per cent more transmissible. According to CNN, reports sent by the task force warn of a possibility of a 'USA variant' of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the spring and summer surges. This acceleration suggests there may be a USA variant that has evolved here, in addition to the UK variant that is already spreading in our communities and maybe 50 per cent more transmissible," said the report.
9th Jan 2021 - Business Today

China to provide COVID-19 vaccines free of charge

China will provide COVID-19 vaccines free of charge once they become available to the general public, government authorities said on Saturday. National Health Commission official Zheng Zhongwei said that while manufacturing and transport of vaccines have costs, the government can provide vaccines for free to individuals.
9th Jan 2021 - Philippine Daily Inquirer

Third covid vaccine approved for use in UK after regulator decision

A third vaccine has been approved for use in the UK. The Medicines and Healthcare products Regulatory Agency has approved the Moderna coronavirus vaccine, the Department for Health has announced. The Government has ordered 17 million doses of the Moderna jab, but supplies will not delivered until the spring. Health Secretary Matt Hancock said: “This is further great news and another weapon in our arsenal to tame this awful disease. “We have already vaccinated nearly 1.5 million people across the UK and Moderna’s vaccine will allow us to accelerate our vaccination programme even further once doses become available from the spring.
9th Jan 2021 - Daily Record

Oxford/AstraZeneca to submit coronavirus vaccine for EU approval next week

The University of Oxford/AstraZeneca will submit their jointly-produced coronavirus vaccine to the European Medicines Agency next week — with a decision on approval for use across the bloc expected by the end of January. The EMA already has the drug-makers' phase 3 data as part of a rolling review, but the vaccine producers are yet to hand a formal submission for conditional marketing authorization from the EU regulator. "Possible conclusion — end of [January], depending on data and evaluation progress," the agency tweeted. The Commission would need to rubber stamp a recommendation from the EMA.
9th Jan 2021 - POLITICO.eu

SAGE warns people must still wear masks AFTER getting Covid vaccine

SPI-B, a sub-group of SAGE, warned some people would stop obeying rules. They said it was crucial that Government told people to continue to be strict. There is no proof that the vaccine will stop people from spreading the virus. Trials only looked at whether the jabs could prevent severe Covid-19
9th Jan 2021 - Daily Mail

'Care needed' after getting Covid vaccine

People who have had Covid vaccines are being warned to still take care. Vaccination has been shown to prevent severe infection, so even if people do catch the virus, they would be protected from getting seriously ill. The call comes as an NHS nurse working for the Hywel Dda University Health Board area said she contracted Covid-19 while waiting for her second dose. The health board said while the vaccine "reduces your chance of suffering", "no vaccine is 100% effective". The Pfizer-BioNtech vaccine, which started being rolled out in the UK last month, offers up to 95% protection against Covid-19 after a second dose.
9th Jan 2021 - BBC News

Cuba to collaborate with Iran on coronavirus vaccine

Communist-run Cuba said late on Friday it had signed an accord with Iran to transfer the technology for its most advanced coronavirus vaccine candidate and carry out last-stage clinical trials of the shot in the Islamic Republic. The allies are both under fierce U.S. sanctions that exempt medicine yet often put foreign pharmaceutical companies off trading with them and as such they seek to be self-reliant. Both are also strapped for cash. Iran launched human trials of its first domestic COVID-19 vaccine candidate late last month, while Cuba has four candidates currently in human trials. Once its most advanced candidate, Soberana (Sovereign) 2, has completed Phase II trials which started on Dec. 22, it will be tested in Phase III trials in around 150,000 people in Havana, officials have said.
9th Jan 2021 - Ottawa Sun

China's COVID-19 vaccine found capable of neutralizing UK strain

China's COVID-19 vaccine is found capable of neutralizing the new strain of the novel coronavirus that was reported to be behind the rise in transmission of the disease in parts of the United Kingdom, senior health official said on Saturday. Zeng Yixin, vice-minister of the National Health Commission, said China's scientific community is paying close attention to the new variant and its effect on current vaccines as reports indicated that the new strain had arrived in China via imported cases. Scientists from the Institute of Laboratory Animal Sciences of the Chinese Academy of Medical Sciences and the Sun Yat-sen University in Guangdong province are already working on the issue, Zeng said during a news briefing held by the State Council Information Office.
9th Jan 2021 - China Daily

Most patients hospitalised with COVID-19 have at least 1 symptom 6 months after falling ill: Wuhan study

More than three quarters of COVID-19 patients have at least one ongoing symptom six months after initially becoming unwell, according to research published in The Lancet. The cohort study, looking at long-term effects of COVID-19 infection on people hospitalised in Wuhan, China, reveals that the most common symptom to persist is fatigue or muscle weakness (63% of patients), with patients also frequently experiencing sleep difficulties (26%). Anxiety or depression was reported among 23% of patients.
9th Jan 2021 - Medical Xpress

Scientists create first computational model of entire virus responsible for COVID-19

Researchers at the University of Chicago have created the first usable computational model of the entire virus responsible for COVID-19—and they are making this model widely available to help advance research during the pandemic. "If you can understand how a virus works, that's the first step towards stopping it," said Prof. Gregory Voth, whose team created the model published in Biophysical Journal. "Each thing you know about the virus's life cycle and composition is a vulnerability point where you can hit it."
8th Jan 2021 - Phys.Org

Three studies highlight low COVID risk of in-person school

In the first study, published today in Pediatrics, a team led by researchers at Duke University traced contacts of North Carolina students infected with COVID-19 in 11 school districts in the first 9 weeks of in-person instruction in the fall. In August 2020, 56 of 115 North Carolina school districts joined the ABC Science Collaborative to put in place specific public health measures to prevent COVID-19 transmission and share what they learn in the process. Superintendents reported primary and secondary cases by school and week of the quarter. The collaborative was developed by faculty at Duke University and the University of North Carolina at Chapel Hill
8th Jan 2021 - CIDRAP

mRNA latecomer CureVac recruits Bayer to speed COVID-19 vaccine to market

Compared with Moderna and the Pfizer-BioNTech partnership, which already have their COVID-19 vaccines authorized for emergency use, CureVac seems a little late to the mRNA race. But now, the biotech has signed a Big Pharma teammate to help accelerate development, boost manufacturing and prep for a possible launch. CureVac partnered up with German compatriot Bayer on its COVID-19 vaccine, CVnCOV, which just entered phase 3 testing three weeks ago. No financial details were provided. The two companies aim to leverage Bayer's expertise and operations to supply “hundreds of millions” doses of the mRNA shot once it’s approved. Along the way, Bayer will help with clinical development, manufacturing, regulatory affairs and commercialization.
8th Jan 2021 - Fierce Pharma

Pfizer, BioNTech COVID-19 vaccine works in more contagious coronavirus variants: study

Newly emerged variants of the novel coronavirus have sparked a key question: Will existing COVID-19 vaccines be less effective against them? But scientists have preliminary data showing that may not be the case, at least for Pfizer and BioNTech’s shot. Researchers from the University of Texas and Pfizer found that, in lab dishes, the vaccine was able to neutralize an engineered version of a variant, which bears an N501Y mutation in its spike protein. The finding was published in bioRxiv and hasn’t been peer-reviewed. Variants of coronavirus with this mutation were first discovered in the U.K. and South Africa and immediately grabbed global attention because they are more contagious.
8th Jan 2021 - Fierce Pharma

Roche's Actemra, Regeneron's Kevzara win U.K.'s favor in COVID-19 after study shows 24% drop in death risk

The question of whether seriously ill COVID-19 patients can benefit from anti-inflammatories like Roche’s Actemra and Sanofi and Regeneron’s Kevzara has dogged practitioners in the United States thanks to conflicting clinical trial results. The United Kingdom, on the other hand, has reached a definitive answer on the two drugs, both of which are IL-6 inhibitors: They significantly reduce the risk of death in COVID-19 patients needing intensive care, and they should be used to ease the pressure hospitals are now facing as the coronavirus pandemic continues to intensify, the country’s National Institute for Health Research (NIHR) said Thursday. The recommendation came after data from an NIHR-sponsored study showed that Actemra and Kevzara can cut hospital stays for COVID-19 patients admitted to intensive care by 10 days and can lower the risk of death by 24% in patients who receive either drug within a day of admission. That finding prompted the U.K. government to recommend to the National Health Service (NHS) that IL-6 inhibitors be rolled out for the treatment of COVID-19.
8th Jan 2021 - Fierce Pharma

Pfizer-BioNTech vaccine not affected by mutation seen in contagious coronavirus variant, study indicates

A mutation found in fast-spreading coronavirus variants does not negate the Covid-19 vaccine from Pfizer and BioNTech, researchers reported late Thursday. The result is positive, if expected, evidence that existing vaccines will be able to withstand some mutations to the SARS-CoV-2 coronavirus without losing efficacy. But experts noted that this vaccine and others will still need to be tested against other mutations of concern, and that the new study only looked at one key mutation contained in the variants, not the full variants. “We’re working on that part now” in additional studies, Philip Dormitzer, Pfizer’s vice president and chief scientific officer of viral vaccines, told STAT.
8th Jan 2021 - STAT News

Hawaiʻi To Receive $95 Million for COVID-19 Vaccine Distribution, Testing and Tracing

US Sen. Brian Schatz (D-HI) announced Hawai‘i will receive nearly $95 million in a new round of federal funding to support the state’s COVID-19 vaccine distribution, testing and contact tracing programs. The funding from the new COVID-19 relief package, which was signed into law in December, will also support COVID-19 surveillance, containment and other mitigation activities. “This money will go directly into making sure the vaccine gets into arms of Hawai‘i health care workers, seniors and everyone else as soon as possible, while also helping us stop the spread of the virus,” said Sen. Schatz, member of the Senate Appropriations Committee. “We will continue working to make sure our state has the resources it needs to vaccinate everybody and keep our communities safe.”
8th Jan 2021 - Maui Now

Most patients hospitalized for Covid-19 still have symptoms six months later, China study finds

Three-quarters of Covid-19 patients still have at least one symptom six months after first falling ill, researchers who followed hospital patients in China reported Friday. The new findings suggest symptoms linger longer and in a higher proportion of patients than previously thought. The largest and longest analysis to date of post-Covid recovery also warns that some patients’ antibody levels fell sharply, raising concern that while waiting for a return to full health, they could be reinfected with the coronavirus. Almost two-thirds of the patients said they were still suffering from fatigue and muscle weakness, the researchers wrote in The Lancet. A little over a quarter had difficulty sleeping, and a little under a quarter experienced anxiety and depression. Overall, more women than men reported lingering symptoms, and people whose disease was more severe had poorer lung health. Their median age was 57.
8th Jan 2021 - STAT News

Pfizer Says Its Covid Vaccine Works Against Key Mutation

Pfizer and BioNTech announced on Friday that their Covid vaccine is effective against one of the mutations present in the new contagious variants identified in Britain and South Africa. Independent experts said the findings were good news, but cautioned that each of those coronavirus variants has several other potentially dangerous mutations that have not yet been investigated. So it’s possible that one of those mutations affects how well the vaccine works. “It’s the first step in the right direction,” said Dr. John Brooks, the chief medical officer for the Centers for Disease Control Covid-19 emergency response. “I’m hoping that the additional work that comes out in the future will fall in line with that finding.”
8th Jan 2021 - The New York Times

Covid Deaths Lowered in Trial of Tocilizumab and Sarilumab

The British government on Friday issued new guidance encouraging health care providers to use two arthritis drugs to treat severely sick Covid-19 patients, following the release of promising data from a clinical trial that has not yet undergone formal scientific review. The findings in a new paper show that treatment regimens involving the drugs tocilizumab or sarilumab reduced the death rate among Covid patients in intensive care to about 27 percent, compared with 36 percent among patients who did not receive the drugs. Based on these results, about one death would be prevented for every 12 I.C.U. patients treated early with these drugs. All of the patients in the trial received the drugs within 24 hours of entering intensive care.
8th Jan 2021 - The New York Times

Covid-19: Lockdown needs to be stricter, scientists warn

Lockdown measures in England need to be stricter to achieve the same impact as the March shutdown, scientists advising the government have said. Prof Robert West said the current rules were "still allowing a lot of activity which is spreading the virus". Prof Susan Michie also said the spread of the new more infectious variant meant the restrictions were "too lax". The government said it had adapted its approach and taken "swift action" to try and stop the spread of the virus. The warnings come after ministers launched a new campaign urging people to act like they have the virus.
8th Jan 2021 - BBC News

An Extra-Contagious Coronavirus Variant Is In The US — But No One Knows How Widespread It Is

A new, highly contagious version of the coronavirus has arrived in the United States, but scientists have no way to track how widespread it is. The new variant, known as B.1.1.7, was first detected in the United Kingdom and, as of Friday, has cropped up in at least 45 other countries. That includes the US, where it has been reported in dozens of cases across at least eight states: California, Connecticut, Colorado, Georgia, Florida, Texas, Pennsylvania, and New York. This version of the virus does not appear to cause infections that are more severe or deadly, and the vaccines now slowly being distributed are still believed to be capable of fending it off.
8th Jan 2021 - BuzzFeed News

6 Months Later, Covid Survivors Plagued by Health Problems

For millions of coronavirus survivors, it’s an increasingly important question: How common, how serious and how long-lasting are the physical and mental aftereffects of Covid-19? A new study — believed to be the largest so far in which doctors evaluated patients six months after they became ill — suggests that many people will experience lingering problems like fatigue, insomnia, depression, anxiety or diminished lung function. The study of 1,733 coronavirus patients who were discharged from a hospital in Wuhan, China, the original epicenter of the pandemic, found that more than three-quarters of them had at least one symptom six months later.
8th Jan 2021 - The New York Times


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Jan 2021

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English health chief says people will get COVID booster shots after guidance change

The head of England’s National Health Service reassured people that they would get their second COVID vaccinations after some appointments were cancelled in order to prioritise giving out more initial doses of the shot. “People will get their second jabs (shots), whether that’s Pfizer or AstraZeneca,” said Simon Stevens, Chief Executive of the National Health Service (NHS), when asked by Reuters at a news conference about the change in guidance which delays second shots for most people to up to 12 weeks after the first dose. He added that the reprioritisation of shots would mean that twice as many people would be offered first doses of the vaccine over the next several weeks.
8th Jan 2021 - Reuters

Moderna's coronavirus vaccine likely prevents infection for 'a couple of YEARS,' CEO says

Moderna Inc CEO Stéphane Bancel said on Thursday the firm's coronavirus vaccine will likely protect for at least 'a couple of years.' He says this is because levels of antibodies against COVID-19 in humans decreases very slowly. Although more research is needed, Bancel said enough evidence shows there is no 'nightmare scenario' of the jab working for just a month or two. Bancel says the biotechnology company is currently working on research that will show it protects against the new variants from the UK and South Africa
8th Jan 2021 - Daily Mail

COVID-19 was circulating silently in Wuhan even after the city reported no cases

COVID-19 may have continued to spread silently in Wuhan, China, during the spring of 2020, even after official government tallies had suggested the coronavirus had been stamped out, a new study suggests. SARS-CoV-2, the virus that causes COVID-19, was first discovered in Wuhan in December 2019, and the city soon became the epicenter of what would become the COVID-19 pandemic. Cases peaked in Wuhan in February 2020 but soon declined rapidly, with just a few cases reported in late March. By early April, the city's lockdown had ended, and later that month, Wuhan was declared coronavirus-free.
7th Jan 2021 - Livescience.com

Look out, pharma. A 'tidal wave' of side effect reports is coming amid COVID-19 vaccine rollouts

With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace for a wave of side effect reports, experts say. And it won't just intensify adverse-event tracking,
7th Jan 2021 - FiercePharma

How Nine Covid-19 Vaccines Work

Researchers are testing 64 coronavirus vaccines in clinical trials on humans. Here are explanations about how nine of the leading vaccines work.
7th Jan 2021 - The New York Times

UAE starts trials of Russia's Sputnik V coronavirus vaccine as cases rise

Abu Dhabi has started Phase III clinical trials of Russia’s Sputnik V COVID-19 vaccine amid a surge in infections in the United Arab Emirates, Abu Dhabi’s media office said on Thursday. The human trial, announced in October before the recent rise in cases, is initially seeking up to 500 volunteers to be vaccinated at a hospital in the emirate of Abu Dhabi. Two doses of the vaccine will be given, 20 days apart, to volunteers, the statement said. The UAE is also conducting Phase III trials of a vaccine developed by China National Pharmaceutical Group (Sinopharm). The UAE has approved the vaccine and it is available for free to anybody who wants it, with priority given to more vulnerable individuals, according to the health ministry.
7th Jan 2021 - Reuters UK

CureVac teams up with Bayer to accelerate development of Covid vaccine

Germany’s CureVac has teamed up with the country’s largest pharmaceuticals company Bayer to accelerate the development and production of its Covid-19 vaccine. The Tübingen-based company, whose vaccine uses a similar technology to the ones developed by BioNTech and Moderna, said on Thursday it had entered into a collaboration and services agreement that would help it deliver several hundred million doses. CureVac, the oldest of the trio of companies working on messenger RNA technology to develop vaccines, was among the first to announce it was working on a product to deal with Sars-Cov-2, the virus that causes Covid-19. But it has since lagged far behind its competitors, both of which have already won authorisations in the US and EU.
7th Jan 2021 - Financial Times

UPDATE 1-Roche, Sanofi arthritis drugs reduce death rates among sickest COVID-19 patients

LONDON, Jan 7 (Reuters) - Treating critically ill COVID-19 patients with Roche’s Actemra or Sanofi’s Kevzara arthritis drugs significantly improves survival rates and reduces the amount of time patients need intensive care,
7th Jan 2021 - Reuters on MSN.com

Critically ill Covid-19 patients to receive new potentially life-saving drugs

Critically ill Covid-19 patients admitted to intensive care units across the UK will be able to receive new drugs that can “significantly” reduce the risk of death as well as time spent in hospital by up to 10 days. NHS patients will have access to tocilizumab and sarilumab – which are typically used to treat rheumatoid arthritis – under updated guidance due to be issued tomorrow by the Government and the NHS to Trusts across the UK. It comes after results from the Government-funded REMAP-CAP clinical trial showed that both drugs reduced the risk of mortality by 8.5% when administered to patients within a day of entering intensive care alongside a corticosteroid, such as dexamethasone.
7th Jan 2021 - ITV News

Coronavirus vaccine: Expert calls China's Sinopharm COVID-19 vaccine 'the most unsafe in the world'

Shanghai doctor Tao Lina claimed that Sinopharm's jab had 73 side effects. He described it as 'the most unsafe in the world' to his 4.8million followers. But the expert denied criticising the drug after his remarks were reported. He denounced foreign media outlets for 'twisting' and 'exploiting' his words
7th Jan 2021 - Daily Mail

Babraham Institute study of Oxford University’s Covid-19 vaccine underscores importance of second dose

A study involving mice suggests the second dose of Oxford University and AstraZeneca’s Covid-19 vaccine will be particularly important to generate an effective immune response in older people. Immunologists at the Babraham Institute studied the effect of age on the immune response to the vaccine. Their findings agreed with vaccine trial data, published in The Lancet, that showed two doses are required for younger and older people to have a similar immune response. Dr Michelle Linterman, a Babraham Institute group leader and lead on the research study, said: “As we get older, our immune system function declines and we become more vulnerable to infectious disease. “The current pandemic has highlighted how much of a health imbalance this can cause. This work has allowed us to analyse the immune system response to the vaccine at cellular resolution and learn more about how age affects this.”
7th Jan 2021 - Cambridge Independent

Covid-19: Stale air can transmit the coronavirus

A Cambridge doctor says he wants the government to do more to warn the public that infected air is a major source of transmission of Covid-19 and that ventilating rooms is just as important as washing hands. He warned that the need to open windows and ventilate indoor spaces to disperse the virus is not being publicised enough by the government when research shows eight out of ten cases are caused by breathing in infected air. And he says cloth masks offer only “minimal protection” against these tiny particles which can stay floating in the air.
7th Jan 2021 - Cambridge Independent

Increased socializing may have jeopardized lockdown benefit in England

Researchers in the UK report that much of the potential beneficial impact of the November 2020 English National lockdown on the coronavirus disease 2019 (COVID-19) epidemic was likely undermined in many areas due to increased socializing in the days running up to its implementation. They say that information leaked about the intended lockdown five days prior to its implementation led to increased socializing in areas that had been categorized as Tier 1 and tier 2 as part of the country’s three-tier system.
7th Jan 2021 - News-Medical.Net

Covid: New study claims five-day warning ruined last England lockdown

On September 21, the UK government’s Science Advisory Group for Emergencies (Sage) published a document calling for a national circuit-breaker lockdown to curb the steadily increasing cases of COVID. The Sage scientists warned that “not acting now to reduce cases will result in a very large epidemic with catastrophic consequences in terms of direct COVID-related deaths and the ability of the health service to meet needs”. Instead of heeding the warnings of their own scientists, the government instead solicited the fringe views of “experts” who advocated for controlling the effects of the virus with less restrictive measures, while shielding society’s most vulnerable.
7th Jan 2021 - Wales Online

How to mitigate the impact of a lockdown on mental health

The Covid-19 pandemic is impacting people's mental health. But what helps and hinders people in getting through a lockdown? A new study led by researchers at the University of Basel addressed this question using data from 78 countries across the world. The results hint at the pivots and hinges on which the individual's psyche rests in the pandemic. At the outset of the Covid-19 pandemic, little was known about the impact of population-wide governmental lockdowns. What was known was taken from restricted quarantines of small groups of people. "On the one hand, such drastic changes to daily routines can be detrimental to mental health," explains Professor Andrew Gloster from the University of Basel, co-leader of the study now published in PLOS One. "On the other hand, because the entire population was more or less equally affected during the lockdown, it remained unclear whether this impact would occur." To address this question, Gloster and his international colleagues conducted an online survey in 18 languages. Almost 10,000 people from 78 countries participated, giving information about their mental health and overall situation during the Covid-19 lockdown.
7th Jan 2021 - EurekAlert!

Sinovac’s Covid-19 Vaccine Is 78% Effective in Brazil Late-Stage Trials

China’s shot also gives 100% protection against severe cases of the disease, said Brazil’s Butantan Institute, raising hopes that it can be widely used in the developing world.
7th Jan 2021 - Wall Street Journal

Hang in there, Australia—we're in great shape, but we're only halfway through the COVID marathon

In the midst of the anxiety over the latest outbreaks in NSW and Victoria, it is easy to forget the wider context of Australia's privileged COVID position. Relative to most Western countries, some of which are losing someone to COVID every 60 seconds, we live in a largely COVID-free oasis. This puts us in an incredibly good position to carefully exit from the COVID crisis and manage a steady return to nationwide normality, without the suffering seen in other nations. But we have 12 months or so to go.
7th Jan 2021 - Medical Xpress

Third Covid vaccine set for UK approval next week but arrival delayed by Brexit

Covid-19: Patients urged to get vaccine as soon as they canBBC NewsAs cases spike, Europe mulls delaying 2nd coronavirus vaccine shotPOLITICO.euModerna's coronavirus vaccine likely prevents infection for 'a couple of YEARS,' CEO saysDaily MailModerna Covid vaccine approved by EUThe IndependentView Full coverage on Google News
7th Jan 2021 - The Guardian

Covid Vaccine Made by Chinese Company Sinovac Is Said to Be Effective

Sinovac Biotech has sold more than 300 million doses to the developing world, filling a gap left by Western countries. Brazilian officials said Thursday that a coronavirus vaccine made by a Chinese company was effective, bolstering the chances of approval for a second Chinese inoculation that could be rolled out in much of the developing world. Officials in the state of São Paulo, where a prominent medical research institute carried out a large study of the vaccine made by the Beijing-based Sinovac, said the inoculation had an efficacy rate of 78 percent.
7th Jan 2021 - The New York Times

Coronavirus vaccine Scotland: NHS advice for pregnant women

The NHS in Scotland has published guidance surrounding the coronavirus vaccine for pregnant women. As of January 3, 113,459 people in the country have received their first dose of the jab, according to Nicola Sturgeon. However, the risks to mums-to-be are still unknown, with the vaccine not yet been tested on pregnant women. According to NHS Inform, the vaccine is not recommended under a precautionary approach.
7th Jan 2021 - Glasgow Times


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Jan 2021

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Welsh researchers developing 'revolutionary' skin patch vaccine for coronavirus

Welsh researchers developing a 'revolutionary' skin patch vaccine for coronavirus say they hope to have a prototype ready as early as March. The body-worn patches - similar to those used by people aiming to give up smoking - are designed to break the skin barrier and deliver medicines in a less invasive way. Swansea University scientists say the world-first 'smart patches' will also be able to tell how effective the vaccine is for each recipient by measuring their body's response. Researchers say the patches could prove a cheaper and easier way of administering vaccines, and would be welcomed by those who dislike traditional hypodermic needles.
6th Jan 2021 - ITV News

COVID-19: Moderna vaccine approved by EU drugs regulator

Moderna's COVID-19 vaccine has been approved for use by the EU's drug regulator. The decision by the European Medicines Agency came on the same day as the Netherland's began administering its first doses against coronavirus. EMA executive director Emer Cooke said: "This vaccine provides us with another tool to overcome the current emergency." The decision, which must be rubber stamped by the EU's executive commission, came hours after nurse Sanna Elkadiri, 39, became the first person in the Netherlands to receive the Pfizer-BioNTech vaccine.
6th Jan 2021 - Sky News

COVID-19: Single vaccine dose leads to 'greater risk' from new coronavirus variants, South African experts warn

Britain is putting vulnerable people at risk from mutant variants of the coronavirus by delaying the second dose of the vaccine, according to South Africa's top adviser on immunisations. South Africa is suffering a sharp spike in cases, driven by a new variant that may reduce the effectiveness of vaccines. That threat has been underlined by new lab tests showing that antibodies may be at least 10 times less effective against the new variant, which is separate to the mutation that was originally identified in England.
6th Jan 2021 - Sky News

South African Covid variant may affect vaccine efficacy, warn scientists

The new coronavirus variant linked to a surge in Covid-19 cases in South Africa is not only more infectious than previous forms of the virus but could make some vaccines less effective. Scientists racing to understand the new strain said they still expected the current crop of approved vaccines to work but were worried that a specific mutation, also identified in a new variant in Brazil, could affect the way the virus responds.
6th Jan 2021 - Financial Times

Moderna COVID-19 vaccine approved in Europe, Dutch play catch-up

COVID-19 vaccine won regulatory approval in Europe on Wednesday and the Netherlands belatedly started its vaccination campaign as European countries accelerated a patchy drive to defeat the coronavirus pandemic.
6th Jan 2021 - Reuters

COVID-19: UK scientists develop first 'skin patch' coronavirus vaccine for those scared of needles

The device from experts at Swansea University is covered in tiny microneedles It would work like a nicotine patch and need to be worn on the arm for 24 hours It has been designed to monitor the body's response to the COVID-19 vaccine The concept could also be adapted to deliver vaccines against other diseases A working model will come before April, and commercial release within 3 years
6th Jan 2021 - Daily Mail

COVID-19: China blocks WHO team from entering country to study coronavirus origin

The head of the World Health Organisation has said he is "very disappointed" China has denied its experts access to investigating the origins of coronavirus. A ten-strong team of international scientists and virologists had been due to set off in early January as part of a long-awaited mission to probe early cases of coronavirus, first reported over a year ago in China's Wuhan province. But Chinese officials have not yet finalised the necessary permissions for the team to enter the country, despite the WHO having been talking with Chinese officials since July.
6th Jan 2021 - Sky News

WHO team investigating origins of Covid denied entry to China

A World Health Organisation (WHO) team due to investigate the origins of Covid in the Chinese city of Wuhan has been denied entry to the country. The WHO said the problem was a lack of visa clearances. The long-awaited probe was agreed upon by Beijing in December after many months of negotiations with the WHO. WHO Director-General Tedros Adhanom Ghebreyesus said he was "disappointed" Chinese officials have not finalised the permissions to allow a team of experts into China.
6th Jan 2021 - Evening Standard

Early convalescent plasma may lower risk of severe COVID in seniors

Plasma from recovered COVID-19 patients with high levels of antibodies appeared to delay or stop progression of illness in mildly ill older adults infected with the novel coronavirus, a study published today in the New England Journal of Medicine concluded. Researchers at Fundacion INFANT in Buenos Aires, Argentina, led the small randomized, controlled, double-blind trial of the effects of infusing convalescent plasma in 160 older adults within 72 hours of symptom onset from Jun 4 to Oct 25, 2020, half of whom received the treatment. The patients were either 75 years and older (88 [55%]), with or without underlying illnesses, or 65 to 74 years with at least one underlying condition (72 [45%]).
6th Jan 2021 - CIDRAP

Governors urged to ensure COVID vaccination as CDC addresses adverse events

Today in separate press conferences the Centers for Disease Control and Prevention (CDC) and members of Operation Warp Speed addressed the two major hurdles facing COVID-19 vaccination campaigns in the United States: slow distribution and safety concerns. Since the vaccines were approved for emergency use in mid-December, most states have focused on vaccinating the recommended top priority groups: healthcare workers and residents of long-term care facilities. But no states have yet to fully use their current allotment of vaccine. "We cannot let perfection be the enemy of good," said Department of Health and Human Services Director Alex Azar during an Operation Warp Speed media briefing on vaccine rollout. "Prioritized recommendations are simply recommendations, they should never stand in the way of getting shots in the arms."
6th Jan 2021 - CIDRAP

European officials OK Moderna vaccine for emergency use

The European Medicines Agency (EMA) today cleared Moderna's COVID-19 vaccine for emergency use, clearing the way for a second vaccine to be used in much of Europe, where the more transmissible B117 variant virus appears to be spreading quickly. In a statement today, the EMA said the vaccine is authorized for use in adults and provides another tool for battling the pandemic. In Ireland, hospitalizations have now topped the country's first peak, according to CNN. Tony Holohan, MBBS, MPH, chief medical officer of Ireland's health department, today warned that the country is in a serious phase of its surge and there is evidence of an increasing presence of the UK variant.
6th Jan 2021 - CIDRAP

Moderna scores COVID-19 vaccine backing in Europe, setting off another major vaccination push

Two weeks after European regulators endorsed Pfizer and BioNTech’s COVID-19 vaccine, a second shot is getting ready for a broad rollout in the region. Moderna scored regulatory support for its vaccine, enabling health officials to expand their vaccination push amid fresh lockdowns and increases in cases. The European Medicines Agency recommended a conditional marketing authorization for Moderna’s vaccine, and the European Commission signed off. The shot “provides us with another tool to overcome the current emergency,” EMA’s executive director Emer Cooke said in a statement. Europe has secured 160 million doses of the vaccine, and the first deliveries are set to begin next week.
6th Jan 2021 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 6th Jan 2021

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COVID-19 vaccine: FDA pushes back against delaying second dose as US officials, health experts weigh in on debate

The U.S. Food and Drug Administration weighed in on a debate over when the first and second doses of the COVID-19 vaccine should be administered. The FDA said in a statement there is no adequate scientific evidence that supports changing the authorized COVID-19 vaccine schedule or dosing. "Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19," the FDA said
5th Jan 2021 - USA Today

Italy to enter capital of ReiThera to support COVID vaccine development

Italy will invest in local biotech company ReiThera to support the development of its COVID-19 vaccine, a senior official said on Tuesday after the government called results of a Phase 1 trial encouraging. ReiThera is developing the vaccine with Germany’s Leukocare and Belgium’s Univercells and started talks with the European Union in September about supplying the bloc with doses. An initial trial involved 45 volunteers aged between 18 and 55. None of them showed serious side effects in the 28 days after the vaccination, said Giuseppe Ippolito, scientific director of Rome’s Lazzaro Spallanzani institute which conducted the tests.
5th Jan 2021 - Reuters India

FDA says changing coronavirus vaccine dosing could put 'public health at risk'

The Food and Drug Administration won't recommend altering the dose regimens of the two coronavirus vaccines currently authorized for emergency use in the U.S. without new clinical data, the agency said late Monday. In an unusual statement, commissioner Stephen Hahn and top agency official Peter Marks warned that changing the way the vaccines are used could put "public health at risk" because those immunized may falsely think they're protected from COVID-19. The vaccines from Moderna as well as partners Pfizer and BioNTech were proven to be 95% protective against symptomatic COVID-19 after two shots given a few weeks apart. Hahn and Marks' opposition comes after the leader of the White House's Operation Warp Speed effort, Moncef Slaoui, suggested using half-doses of Moderna's vaccine, citing study results indicating the immune response generated appeared equally strong in adults 18 to 55 years of age given doses half as strong as the one authorized.
5th Jan 2021 - BioPharma Dive

No sign S.Africa's COVID-19 variant more contagious than UK version -WHO

There is no indication that the coronavirus variant identified in South Africa is more transmissible than the one spreading fast in Britain, the World Health Organization's technical chief on COVID-19,
5th Jan 2021 - Reuters

WHO recommends two doses of Pfizer COVID-19 vaccine within 21-28 days

People should get two doses of the Pfizer and BioNTech vaccine within 21-28 days, the World Health Organization said on Tuesday, as many countries struggled to administer the jabs that can ward off the COVID-19 virus. Many are experiencing intensifying pressure on their health services due to surging coronavirus cases and the emergence of new variants that appear to spread more easily. Governments are introducing new lockdown measures to halt the spread while facing massive demand for vaccines which are seen as the best way out of the global health crisis. But with jabs in limited supply as production ramps up, the WHO has been examining how they can be used most effectively.
5th Jan 2021 - Reuters

Relief for cancer patients as study shows those with solid tumours have the same level of immune response to Covid-19 as healthy people

Charity Cancer research UK studied blood samples of 76 cancer patients Forty-one of these patients tested positive for Covid-19 and 35 were uninfected Reveals people with solid tumours respond in same way as non-cancer patients But also found people with blood cancer have a milder immune response
5th Jan 2021 - Daily Mail

Covid-19 in South Africa: Scientists seek to understand new variant

Scientists in South Africa say there is a "reasonable concern" that the new variant of Covid-19 sweeping across the country might prove to be more resistant to current vaccines being rolled out in the UK and elsewhere, and warn that it makes the need for a global roll-out of vaccines "even more critical". "It's a theoretical concern. A reasonable concern… that the South African variant might be more resistant," Prof Shabir Madhi, who has led trials for the Oxford-AstraZeneca vaccine in South Africa, told the BBC. Prof Madhi was responding to comments by the UK government and scientists. He said a definitive answer would probably come in a matter of weeks, with extensive testing already under way in South Africa.
5th Jan 2021 - BBC News

No data to support delay of second Covid vaccine dose, say Pfizer and BioNTech

BioNTech and Pfizer have warned against delaying the provision of a second dose of their vaccine, after the UK government adopted the strategy in an attempt to make the country’s supplies go further. Amid an escalation in Covid-19 cases across the four nations – driven in part by the new coronavirus variant – government health officials heeded calls to roll out initial supplies of the vaccines to as many people as possible, rather than holding back jabs to give second doses to those who have received the first.
5th Jan 2021 - The Independent

The Nigerian scientist sequencing new COVID strain as cases rise

A Nigerian scientist has spent the holiday season in his laboratory doing genetic sequencing to learn more about the country’s COVID-19 variant, as cases increase in the country. Virologist Sunday Omilabu says the information he gathers about the variant will help battle the spread of the disease in Nigeria, Africa’s most populous country with 196 million people. Nigeria has confirmed 89,163 COVID-19 cases, including 1,302 deaths, according to the figures released on Sunday by the Africa Centers for Disease Control and Prevention. “The variants discovered in the UK and South Africa, they are distantly different from the variants discovered in Nigeria,” said Omilabu, who said it is not unusual for viruses to mutate and cause variants. Nigeria is seeing more infections of COVID-19 but it is not yet certain if that is from the variant, said Omilabu, the director of the Centre for Human and Zoonotic Virology at the Lagos University College of Medicine and Teaching Hospital.
4th Jan 2021 - Al Jazeera English

Study: US COVID cases, deaths far higher than reported

An estimated 14.3% of the US population had antibodies against COVID-19 by mid-November 2020, suggesting that that the virus has infected vastly more people than reported—but still not enough to come close to the proportion needed for herd immunity, according to a study published today in JAMA Network Open. In the cross-sectional study, researchers from study sponsors Pfizer and Merck analyzed data from random community seroprevalence surveys and five such regional and national Centers for Disease Control and Prevention (CDC) surveys to estimate infection underreporting multipliers. Seroprevalence surveys reveal the proportion of a population that has antibodies against a certain disease, such as COVID-19.
5th Jan 2021 - CIDRAP

WHO experts weigh in on COVID-19 vaccine dose interval

The World Health Organization (WHO) vaccine advisory group today weighed in with recommendations for delivering the Pfizer-BioNTech vaccine, urging the vaccine doses be given 21 to 28 days apart in most circumstances, but in certain situations allowing for an interval of up to 6 weeks. The new guidance comes as countries rush to get their vaccination drives up and running as they face the prospect of wider circulation of more transmissible SARS-CoV-2 variants. It also comes just days after the WHO announced its first emergency use listing for a COVID-19 vaccine, the one from Pfizer-BioNTech.
5th Jan 2021 - CIDRAP

Not so fast: FDA warns of 'premature' changes to COVID-19 vaccine dosing in clash with Slaoui

Amid concerns over limited COVID-19 vaccine supplies, some have proposed tweaking the shots’ dosing to immunize more people. One suggestion came from none other than U.S. vaccine czar Moncef Slaoui, Ph.D. But the FDA’s stepping forward to dismiss the idea—at least for now. Any changes to currently authorized vaccine dosing regimens pose a “significant risk of placing public health at risk” and undermine “the historic vaccination efforts to protect the population from COVID-19,” FDA Commissioner Stephen Hahn, M.D., and Peter Marks, M.D., Ph.D., head of the agency’s biologics department, said in a statement Monday. The comment came on the heels of Operation Warp Speed chief Slaoui saying the vaccine task force is working with the FDA and Moderna to potentially reduce the company’s mRNA-1273 dose in half to stretch the supply.
5th Jan 2021 - Fierce Pharma

Moderna dials up low-end COVID-19 vaccine supply estimate, setting sights on 1B doses in 2021

Moderna Therapeutics is angling to surpass the hundreds of millions of COVID-19 vaccine doses it’s already pledged to governments worldwide. And, on Monday, the drugmaker signaled that it's inching toward that goal, dialing up its low-end manufacturing predictions for the year. Moderna has raised its base-case global production estimate from 500 million doses to 600 million doses this year. The supply bump comes as the company continues to invest and staff up, with a view to potentially hit 1 billion doses in 2021, Moderna said. The company will need those extra doses, too: It recently received expanded vaccine orders from the likes of Canada, the U.S. and the EU. The FDA in December cleared the shot for emergency use in Americans 18 years and older, with Health Canada following suit a week later.
5th Jan 2021 - FiercePharma

UK scientists question COVID-19 vaccine dosing delay

Five UK medical scientists have criticised a British government plan to delay giving second doses of COVID-19 vaccines by up to 12 weeks, saying proven dosing schedules should not be altered “without solid scientific support or evidence”. In an opinion piece published online in the BMJ British Medical Journal, the scientists said the plan was based on “assumptions” rather than scientific evidence or trial data. They also questioned the rationale behind prolonging the time between first and second doses. The scientists from the universities of Nottingham, Manchester and De Montfort wrote that suggestions by officials on the government’s Joint Committee on Vaccines and Immunization (JCVI) that the delay strategy was due to shortages of COVID-19 shots in the UK were “disputed by vaccine manufacturers”.
5th Jan 2021 - Reuters UK

Explainer-How safe is it to switch and space COVID-19 vaccine doses?

Britain and other nations are considering ways to stretch scarce supplies of COVID-19 vaccines, including by delaying second doses, reducing dose sizes and switching vaccine types between the first and second shots.
5th Jan 2021 - Reuters UK

Brazil scrambles to secure COVID vaccine from India

Brazil made a diplomatic push on Monday to guarantee an Indian-made shipment of British drugmaker AstraZeneca’s COVID-19 vaccine, hoping to avoid export restrictions that could delay immunisations during the world’s second-deadliest outbreak. In parallel, Brazil’s private clinics struck a preliminary deal for an alternative injection made by India’s Bharat Biotech despite a lack of public results from late-stage trials.
5th Jan 2021 - Al Jazeera English


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 5th Jan 2021

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BioNTech says no data to support delayed COVID-19 vaccine booster shot

Germany was weighing on Monday (Jan 4) whether to allow a delay in administering a second dose of the COVID-19 vaccine from BioNTech and Pfizer to make scarce supplies go further, after a similar move by Britain last week. Separately, Denmark approved on Monday a delay of up to six weeks between the first and second shots of the vaccine. In Berlin, the health ministry was seeking the view of an independent vaccination commission on whether to delay a second shot beyond a current 42-day maximum limit, according to a one-page document seen by Reuters on Monday.
5th Jan 2021 - Channel NewsAsia Singapore

Moderna raises production goal of its coronavirus vaccine from 500 to 600 million by the end of 2021

On Monday, Moderna Inc said it will produce a minimum of 600 million coronavirus vaccine doses in 2021. This is 20% higher that the 500 million doses the firm said it would be able to manufacture by year's end. So far, Moderna has distributed 18 million doses of the 200 million it has promised the federal government. The vaccine rollout in the U.S. has been very slow, with just 4.2 million people receiving shots, short of the 20 million the Trump administration hoped for
4th Jan 2021 - Daily Mail

Covaxin: Concern over 'rushed' approval for India Covid jab

Experts have raised concerns over India's emergency approval of a locally-produced coronavirus vaccine before the completion of trials. On Sunday, Delhi approved the vaccine - known as Covaxin - as well as the global AstraZeneca Oxford jab, which is also being manufactured in India. Prime Minister Narendra Modi touted the approval as a "game changer". The head of Bharat Biotech, which makes Covaxin, defended the approval process, but health experts warn it was rushed. It said that there were "intense concerns arising from the absence of the efficacy data" as well a lack of transparency that would "raise more questions than answers and likely will not reinforce faith in our scientific decision making bodies". The statement came after India's Drugs Controller General, VG Somani, insisted Covaxin was "safe and provides a robust immune response". He added the vaccines had been approved for restricted use in "public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains".
4th Jan 2021 - BBC News

Uproar after India's Covid-19 vaccine is approved before clinical trials end

India's indigenously produced Covid-19 vaccine is at the centre of a controversy after it was licensed with clinical trials for effectiveness still incomplete. Covaxin was granted emergency approval on Sunday (Jan 3) by the Indian drug regulator. Also getting the nod was AstraZeneca-Oxford University's Covishield, to be made in India by Serum Institute, the world's largest vaccine producer by volume. The decision to approve Covaxin, developed and manufactured by Hyderabad-based Bharat Biotech, triggered a row. The Indian health minister said it was granted permission for "restricted use in emergency situations" in the "larger public interest".
4th Jan 2021 - The Straits Times

South Africa testing whether vaccines work against its variant

Scientists in South Africa are urgently testing to see if the vaccines for COVID-19 will be effective against the country s variant virus. The genomic studies come as Britain’s health minister, Matt Hancock and other experts in the U.K. have said they worry that vaccines may not be effective against the South African variant. “This is the most pressing question facing us right now,” said Dr. Richard Lessells, an infectious diseases expert who is working on the country's genomic studies of the variant. “We are urgently doing experiments in the laboratory to test the variant," against the blood of people with antibodies and against the blood of people who have received vaccines, Lessells told The Associated Press Monday.
4th Jan 2021 - The Independent

TGA still waiting for 'further data' on AstraZeneca vaccine

Concerns over new coronavirus cases in Sydney and Melbourne look unlikely to prompt an accelerated approval and rollout of vaccines in Australia, with the local regulator still waiting on further data from AstraZeneca about its vaccine. The Oxford-AstraZeneca product is the only vaccine set to be made in Australia at this stage, with biotechnology giant CSL set to produce 50 million doses this year, subject to approvals. AstraZeneca has long hoped for approvals and rollout across the globe by the end of January, however, neither the Therapeutic Goods Administration (TGA) nor AstraZeneca have confirmed when they expect the process to be completed. The product was approved for use in the UK on December 30.
4th Jan 2021 - Sydney Morning Herald

Peer-reviewed data show high protection for leading COVID vaccines

The peer-reviewed data on both the Moderna and Pfizer/BioNTech COVID vaccines are in, demonstrating 94% to 95% protection from the disease. The phase 3 clinical trial results for the Moderna COVID-19 vaccine, mRNA-1273, and the Pfizer/BioNTech COVID-19 vaccine, BNT162b2 or Comirnaty, were published late last week in the New England Journal of Medicine (NEJM). When compared with placebos, Moderna's vaccine showed 94.1% efficacy (95% confidence interval [CI], 89.3% to 96.8%), and Pfizer's had 95.0% efficacy (95% CI, 90.3% to 97.6%). Both rates are for patients who received the two intended doses. Adverse events were uncommon in both studies.
4th Jan 2021 - CIDRAP

New death risks noted in nursing home residents with COVID-19

Older age, male sex, and physical and cognitive impairments were linked to higher death rates from any cause in 5,256 residents at 351 US nursing homes, according to a study published today in JAMA Internal Medicine. Led by researchers at Brown University, the cohort study involved mining the electronic health records, daily infection logs, and minimum data sets of resident assessments from a large chain of nursing homes in 25 states from Mar 16 to Sep 15, 2020. By 30 days after their first positive COVID-19 test result, 1,129 of the 5,256 residents (21%) had died from any cause.
4th Jan 2021 - CIDRAP

Scientists cast doubt on WHO’s China mission to find virus origin

In the coming days, bar any last-minute hitches, 10 renowned international scientists will check into Chinese hotel rooms for two weeks of quarantine. So will start the World Health Organisation (WHO) mission of foreign experts to investigate the coronavirus, a year after the first reports emerged of a mystery disease sweeping the central city of Wuhan. The stakes could not be higher in the hunt for the origins of the greatest public health challenge of our era, amid persistent warnings that the world needs to prepare for much more deadly pandemics. But the mystery has become even harder to solve. Beijing has delayed the arrival of the WHO team for months with a barrage of logistical demands and rules.
3rd Jan 2021 - The Times

Experts Debate Wisdom of Delaying Second COVID-19 Vaccine Dose

The two experts state that supply constraints, distribution bottlenecks, and hundreds of thousands of new infections daily prompted them to change their stance on administering COVID-19 vaccines according to the two-dose clinical trial regimen. Furthermore, they cite a study in the New England Journal of Medicine that suggests 80% to 90% efficacy for preventing SARS-CoV-2 infection following one dose of the Moderna vaccine. Not everyone agrees one dose is a good idea. "Clinical trials with specific schedules for vaccine dosing — that's the whole basis of the scientific evidence," Maria Elena Bottazzi, PhD, associate dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, Texas, told Medscape Medical News. After one dose "the immune system is learning, but it's not ideal. That's why you need the second dose," Bottazzi said. "I appreciate the urgency and the anxiety…but the data support [that] clinical efficacy requires two doses."
4th Jan 2021 - Medscape


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Timeline: India's coronavirus vaccine approved by drugs experts

India’s drugs regulator on Saturday recommended for emergency use a locally developed coronavirus vaccine called COVAXIN, which is expected to be a backup to the AstraZeneca/Oxford shot. Not much is known about the safety and efficacy of COVAXIN. The company says it has submitted all data to the drugs regulator. The head of India’s drugs regulator is expected to share details about it at a news conference on Sunday, when its formal approval is likely to be announced.
3rd Jan 2021 - Reuters

Wuhan: nearly 490,000 people could have had Covid, study finds

A Chinese study of coronavirus antibodies has found almost half a million people may have had Covid-19 in Wuhan, a number that is 10 times the official figure. According to the study of antibody prevalence, the infection rate was also far higher in Wuhan than surrounding areas, suggesting the virus had been well contained in the city where the outbreak first began. The study, conducted by the Chinese Center for Disease Control and Prevention (CDC), tested for antibodies in blood serum samples from around 34,000 people in Wuhan and other Hubei province cities, as well as the cities of Beijing and Shanghai and the provinces of Guangdong, Jiangsu, Sichuan and Liaoning.
2nd Jan 2021 - The Guardian

India's drug regulator approves AstraZeneca/Oxford vaccine: sources

India’s drug regulator on Friday approved a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, two sources with knowledge of the matter told Reuters. The decision clears the vaccine’s rollout in the world’s second-most populous country which, after the United States, has the highest number of COVID-19 infections. India wants to start administering the vaccine soon, most likely by Wednesday, said one of the sources, both of whom declined to be named ahead of an official announcement expected later in the day.
2nd Jan 2021 - Reuters

Pfizer and BioNTech to offer COVID vaccine to volunteers who got placebo

Pfizer Inc and its partner BioNTech Se plan to give volunteers who received a placebo in its COVID-19 vaccine trial an option to receive a first dose of the vaccine by March 1, 2021, while staying within the study. The trial's Vaccine Transition Option allows all participants aged 16 or older the choice to discover whether they were given the placebo, "and for participants who learn they received the placebo, to have the option to receive the investigational vaccine while staying in the study," the companies said on their website here for trial participants. The U.S. Food and Drug Administration and a panel of its outside advisers have expressed concerns over Pfizer’s “unblinding” plan, saying it could make it harder to continue collecting data on safety and effectiveness needed to win full FDA approval of the vaccine.
2nd Jan 2021 - Reuters

Russia ready to trial combined AstraZeneca, Sputnik V vaccine in Ukraine

Russia is ready to conduct clinical trials in Ukraine of a COVID-19 vaccine combining its Sputnik V with a vaccine developed by AstraZeneca together with Oxford University, the head of Russian Direct Investment Fund (RDIF) said on Saturday. Russia’s sovereign RDIF, which is marketing the Sputnik V vaccine abroad, announced in December trials to test a combination of the AstraZeneca vaccine with the Sputnik V shot to see if this can boost the efficacy of the British drugmaker’s vaccine.
2nd Jan 2021 - Reuters UK

1.8 mln doses of Sinovac COVID-19 vaccine arrive in Indonesia

A total of 1.8 million doses of COVID-19 vaccine made by the Chinese biopharmaceutical company Sinovac Biotech arrived in Indonesia on Thursday, according to Indonesian government officials. Foreign Minister Retno Marsudi said this is the second batch of the Sinovac vaccine delivery for Indonesia, and the first batch of 1.2 million doses arrived on Dec. 6. "With this arrival, it means that there are already 3 million doses of Sinovac vaccine in Indonesia," Marsudi told a virtual press conference. Health Minister Budi Gunadi Sadikin said vaccination is one of Indonesia's main strategies to fight the COVID-19 pandemic, adding, "It would take more than 12 months to complete the vaccination program, so we always keep up to health protocols."
1st Jan 2021 - Xinuhanet

No approval for Covaxin, expert panel seeks more data from Bharat Biotech

The Subject Expert Committee of the Central Drug Standard Control Organization on Friday has held that the data provided by Bharat Biotech for its coronavirus vaccine 'Covaxin' is not sufficient for granting it emergency use approval and has asked the company to provide more information
1st Jan 2021 - Times of India

Could a breathalyser help detect COVID-19? Indonesian scientists say they've developed one

Indonesian scientists have developed a simple breathalyser test that they say can electronically "smell' coronavirus and detect infection in under two minutes. The GeNose C-19 device uses artificial intelligence — in the form of an electronic nose — to analyse a breath sample and identify elements that are unique to COVID-19. The Indonesian Government last week granted a distribution permit for GeNose and hopes to roll out thousands of the devices by February. The aim is that this will increase mass testing of coronavirus at hospitals, airports, seaports and other public places in the world's fourth most populous country.
1st Jan 2021 - ABC News

Pfizer and BioNTech speed up timeline for offering Covid-19 vaccine to placebo volunteers

Pfizer and its partner BioNTech plan to offer their Covid-19 vaccine to any clinical trial volunteer who received placebo by March 1, several months earlier than initially planned. The decision represents the conclusion of a complex and public kabuki dance between the FDA, Pfizer, and vaccine volunteers, as well as with Moderna, which developed its own Covid-19 vaccine. The FDA and its advisers pushed hard for volunteers to remain on placebo as long as possible to gather more safety and efficacy data about the vaccines, while the companies argued volunteers should receive the vaccines sooner for both ethical and practical reasons.
1st Jan 2021 - STAT News

Indian regulators are pushed to release Covid-19 vaccine trial protocol

As Indian regulators consider emergency approval of a Covid-19 vaccine from the Serum Institute of India, consumer groups are urging authorities to release key documents amid concerns over transparency and adverse events. An independent panel of experts set by the Drug Controller General of India meets on Friday to consider the vaccine, which is the Serum Institute’s version of a shot originally co-developed by AstraZeneca and the University of Oxford. Consumer advocates, however, maintain Indian regulators should disclose more details before proceeding, especially since the Indian Council of Medical Research is providing support for a so-called bridging trial that is being conducted in the Indian population. Consumer groups are concerned that it is not clear whether the Serum Institute has submitted all safety and immunogenicity data from analyses of the bridging study to regulators
1st Jan 2021 - STAT News

Covid vaccine shortages will last months, Chris Whitty says

Vaccine shortages will be a problem for months, England’s chief medical officer warned last night as the government faced a revolt by GPs over cancelled second jabs for elderly patients. Chris Whitty and his counterparts from the other home nations made clear that struggles to get hold of supplies were likely to be the main reason why more people could not be vaccinated, and he defended a shift towards giving first doses. “Vaccine shortage is a reality that cannot be wished away,” he said in a letter to doctors. In England 786,000 people have had a first dose of the Pfizer vaccine, with 264,406 jabs in Christmas week. In the UK the total is 944,539.
1st Jan 2021 - The Times

BioNTech founders warn of vaccine supply gaps - Spiegel

BioNTech is working flat out with partner Pfizer to boost production of their COVID-19 vaccine, its founders said, warning there would be gaps in supply until other vaccines were rolled out. The German biotech startup has led the vaccine race but its shot has been slow to arrive in the European Union because of relatively late approval from the bloc’s health regulator and the small size of the order placed by Brussels. The delays in rolling out the home-grown vaccine have caused consternation in Germany, where some regions had to halt vaccinations within days of starting an inoculation drive.
1st Jan 2021 - Reuters UK

Different efficacy data for Chinese COVID-19 vaccine 'real and valid' - media

Different efficacy results for a Chinese COVID-19 vaccine released separately in China and in United Arab Emirates are both real and valid, an executive at China National Biotec Group (CNBG) told state media. China approved its first COVID-19 vaccine for general public use on Thursday, a shot developed by an affiliate to state-backed Sinopharm, after the developer said the vaccine showed 79.34% efficacy based on an interim analysis of late-stage clinical trials. That rate is lower than the 86% rate for the same vaccine reported by the United Arab Emirates on Dec. 9.
1st Jan 2021 - Reuters UK

AstraZeneca expects to supply two million doses of COVID-19 vaccine every week in UK - The Times

About two million doses of COVID-19 vaccine developed by Oxford University and AstraZeneca are set to be supplied every week by the middle of January in the United Kingdom, The Times reported. AstraZeneca expects to supply two million doses of the vaccine in total by next week, the newspaper reported, citing an unnamed member of the Oxford-AstraZeneca team. “The plan is then to build it up fairly rapidly - by the third week of January we should get to two million a week,” the report added.
1st Jan 2021 - Reuters UK

Pfizer’s COVID-19 vaccine expected to get EUA by January — FDA

The application for Emergency Use Authorization (EUA) of  American pharmaceutical firm Pfizer in the Philippines may be approved before the end of
31st Dec 2020 - Philippine Daily Inquirer

Pfizer warns there is NO proof its Covid jab works when doses are taken 12 weeks apart as UK regulator scraps 21-day rule in desperate attempt to get millions more vaccinated

Regulator now recommending jabs are given in two doses three months apart Originally Pfizer and Oxford jabs intended to be injected in space of four weeks Change in strategy is to cope with spiking Covid cases and hospitalisations
31st Dec 2020 - Daily Mail

WHO lists Pfizer-BioNTech COVID vaccine for emergency use

The World Health Organization has listed Pfizer-BioNTech’s COVID-19 vaccine for emergency use, a critical step that the United Nations health agency said aims to make the vaccine more readily available in developing nations. In a statement on Thursday, WHO said its validation of the vaccine – the first since the start of the pandemic – “opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine”.
31st Dec 2020 - Al Jazeera English

Covid vaccine advice to people with severe allergies changes after Oxford jab approval

Coronavirus vaccine advice to people with severe allergies has changed after today's approval of the Oxford jab. People with a history of "significant" allergic reactions to medicines, food or vaccines were advised they should not receive the Pfizer vaccine when it was approved earlier this month. However, professor Sir Munir Pirmohamed, chairman of the Commission on Human Medicines expert working group on Covid-19 vaccines, gave updated advice for those with allergies following the approval of the Oxford vaccine today. He said: "We've come to the recommendation people with a known history of reacting to any specific ingredients of vaccines should not have it, but people with allergies to other medicines or food can have the vaccine.
30th Dec 2020 - Mirror Online

Survey: COVID vaccine willingness waned since April

National survey results published yesterday in JAMA Network Open show that the number of people who say they are somewhat or very likely to seek COVID-19 vaccination fell from 74% to 56% from April to December, after press coverage of high effectiveness for two vaccines in phase 3 trials but before they were authorized for emergency use in the United States. The study results, published as a research letter, were based on biweekly, online, probability-based tracking surveys of 8,167 community-dwelling adult US participants in the Understanding America Study, led by researchers at the University of California, Los Angeles. Each survey prompted responses from 5,259 to 6,139 participants, with completion rates of 75% to 97%.
30th Dec 2020 - CIDRAP

Covid-19 Vaccine Made by AstraZeneca, Oxford Is Authorized by U.K.

The U.K. authorized a Covid-19 vaccine developed by the University of Oxford and AstraZeneca PLC, opening the door for distributing millions of doses in a country where a more infectious variant of the coronavirus has contributed to surging cases. British health officials also recommended a delay of as long as three months between both doses of the vaccine, guidance that also applies to the shot developed by Pfizer Inc. and BioNTech SE that the U.K. authorized earlier this month. The delay will allow inoculations to reach more people more quickly as the variant pushes new cases to records and hospitalizations soar. The green light represents the third emergency-use approval of a Western-developed vaccine this month and comes as cases rise sharply in Europe and the U.S., which reported its first confirmed case of the variant Tuesday. The Pfizer-BioNTech shot and one developed by Moderna Inc. have been cleared in the U.S.
30th Dec 2020 - Wall Street Journal


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Exclusive: Chile could greenlight AstraZeneca vaccine 'within days of US/UK approval, government says

AstraZeneca has filed data with Chilean regulators for the emergency roll-out of its COVID-19 vaccine in the country and could get a green light “weeks or even days” after approval by European or American regulators, the government’s point person for vaccine procurement told Reuters. The UK-based company has been conducting late-stage trials of its vaccine, developed with Oxford University, in Chile as well as in Brazil, the UK, the United States and South Africa. Chile has signed a deal to buy 14.4 million doses of the drug, an amount that would vaccinate half that number of people, or nearly 40% of the country’s population. Chile is already among the best-placed in the region for vaccine deals, with an agreement for 10 million doses from Pfizer BioNtech, 60 million doses over three years from China’s Sinovac and 7.6 million vaccine doses through the global vaccine distribution scheme COVAX.
30th Dec 2020 - Reuters UK

New coronavirus variant does not cause illness more severe than others -Public Health England study

A new variant of the novel coronavirus does not appear to cause more severe illness than other variants, according to a matched study bit.ly/2X7cLgp by Public Health England. Scientists say the new variant can spread more rapidly. It was found in England in mid December and led to other countries imposing travel restrictions to the United Kingdom. Several other countries have reported variants. Under the study, researchers compared 1,769 people infected with the new variant with 1,769 who had what they described as “wild-type” virus. The two groups were matched 1:1 on the basis of age, sex, area of residence and time of testing.
30th Dec 2020 - Reuters

COVID-19 vaccine: India may get most of Serum Institute's initial Covishield stockpile

Poonawalla says Covishield shows efficacy level of 95 per cent provided two shots are taken after a gap of 2-3 months; AstraZeneca will make that public with documentation soon, he adds
29th Dec 2020 - Business Today

Will COVID-19 vaccines work on the new coronavirus variant?

Will COVID-19 vaccines work on the new coronavirus variant? Experts believe so, but they're working to confirm that. A coronavirus variant in the United Kingdom has caused alarm because of the possibility that it might spread more easily. But even if that turns out to be true, experts say the COVID-19 vaccines being rolled out will likely still work on the variant. Dr. Anthony Fauci the top U.S. infectious disease expert, said data coming from Britain indicates the vaccines still will block the virus. But the U.S. also will do tests to be sure. Viruses often undergo small changes as they reproduce and move through a population. In fact, the slight modifications are how scientists track the spread of a virus from one place to another.
29th Dec 2020 - The Independent

Arcturus Therapeutics shares slide 55% after COVID vaccine data are deemed 'underwhelming'

Shares of biotech company Arcturus Therapeutics Holdings Inc. slid 55% Tuesday, as investors responded to results from a Phase 1/2 trial of its COVID-19 vaccine candidate that one analyst said were disappointing. San Diego–based Arcturus ARCT, -54.17% said late Monday that it has received approval from the Singapore Health Sciences Authority to move ahead with a Phase 2 study of its ARCT-021 vaccine candidate that will enroll up to 600 volunteers. The approval is based on Phase 1/2 trial data that showed the vaccine produced neutralizing antibodies after one dose although at lower levels than rival vaccine candidates. Arcturus is hoping its vaccine will not require a booster shot, making it easier to administer than vaccines that require two doses.
29th Dec 2020 - MarketWatch

Iran begins human trials of its homegrown Covid vaccine

The daughter of the man leading one of Iran’s most infamous religious foundations today became the first person in the country to test its homegrown coronavirus vaccine on Tuesday. Tayebeh Mokbher appeared in good health afterward. “I am happy not just because I'm the first person to receive the vaccine, but also that our country's science has advanced so much,” she said in a segment broadcast on state television immediately after she took a jab of Blessed Coviran, the country’s still-experimental coronavirus vaccine.
29th Dec 2020 - The Independent

Novavax launches late-stage US coronavirus vaccine trial

Novavax has begun a large late-stage study of its experimental COVID-19 vaccine in the U.S., the drug developer said on Monday, after delaying the trial twice due to issues in scaling up the manufacturing process. It will enroll up to 30,000 volunteers across about 115 sites in the United States and Mexico, with two-thirds of them receiving the shot 21 days apart and the rest getting placebo, the company said. Novavax lags behind other drugmakers in the global race for COVID-19 vaccine, with shots from Pfizer and Moderna authorized for emergency use in the United States.
29th Dec 2020 - Daily Mail

Consortium working with medical authorities on approval for Covid-19 rapid test

A consortium that includes medical diagnostics company Omega is working with the Medicines and Healthcare products Regulatory Agency (MHRA) to enable approval for its Covid-19 lateral flow antibody test. The Alva-based company is part of the consortium led by AIM-listed Abingdon Health developing the AbC-19 Rapid Test. Abingdon, which is York-based, said that while the UK's Department of Health and Social Care has first refusal of supplies of the test through a contract that runs to 14 February, it is also working on potential international distribution. The UK Rapid Test Consortium liaising with customers and regulatory authorities across a total of 27 international territories, to allow future use of the product outside of the UK.
29th Dec 2020 - Insider.co.uk

WHO warns Covid-19 pandemic is 'not necessarily the big one'

World Health Organization experts have warned that even though the coronavirus pandemic has been very severe, it is “not necessarily the big one”, and that the world will have to learn to live with Covid-19. The “destiny” of the virus is to become endemic, even as vaccines begin to be rolled out in the US and UK, says Professor David Heymann, the chair of the WHO’s strategic and technical advisory group for infectious hazards. “The world has hoped for herd immunity, that somehow transmission would be decreased if enough persons were immune,” he told the WHO’s final media briefing for 2020.
29th Dec 2020 - The Guardian

Pressure grows on Government to keep schools closed despite plans for military to help coronavirus testing of pupils

Military personnel will be drafted in to support coronavirus testing of school and college students in England if the Government withstands the growing pressure to delay the reopening of secondaries.
29th Dec 2020 - Evening Standard on MSN.com

Covid: UK faces 'catastrophe' without tougher action, warns scientist

A surge in coronavirus cases in the UK is of "extreme concern", a health boss says, as a record number of cases was reported for the second day running. On Tuesday, 53,135 new Covid cases were recorded as well as 414 more deaths within 28 days of a positive test. Not all data was reported in full over the Christmas period, leading to a lag in some data, but Public Health England said there had been a "real increase". The health secretary said the NHS was facing "unprecedented pressures". Ahead of an announcement on any changes to England's tier restrictions on Wednesday, Matt Hancock added in a tweet: "We must suppress this virus to protect our NHS & save lives until the vaccine can keep us safe."
29th Dec 2020 - BBC News

Study: Britain Must Vaccinate 2 Million a Week to Prevent Third COVID-19 Wave

Britain must vaccinate 2 million people a week to avoid a third wave of the coronavirus outbreak, a study by the London School of Hygiene and Tropical Medicine (LSHTM) has concluded. Britain has had more than 71,000 deaths from the coronavirus and has recorded more than 2.3 million cases of COVID-19 infections as of late Monday, according to Johns Hopkins University data. "The most stringent intervention scenario, with tier 4 [restrictions] England-wide and schools closed during January and 2 million individuals vaccinated per week, is the only scenario we considered which reduces peak ICU burden below the levels seen during the first wave," the study said.
29th Dec 2020 - Voice of America

UK needs tighter COVID rules to avert new 'catastrophe', epidemiologist warns

Britain reported 41,385 new COVID-19 cases on Monday, the highest number since testing became widely available in the middle of 2020, and hospitals have more COVID-19 patients than during the first wave of the pandemic in April. “We are entering a very dangerous new phase of the pandemic, and we’re going to need decisive early national action to prevent a catastrophe in January and February,” Andrew Hayward, professor of infectious disease epidemiology at University College London, told the BBC.
29th Dec 2020 - Reuters UK

Regeneron's COVID-19 antibody therapy shows promise in hospitalized patients

Regeneron Pharmaceuticals Inc said on Tuesday initial data from an ongoing study of its experimental antibody cocktail for use in hospitalized COVID-19 patients requiring low-flow oxygen show the therapy was sufficiently effective to warrant continuing the trial. The drugmaker said in September the cocktail, a combination of two antibodies casirivimab and imdevimab, reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients.
29th Dec 2020 - Reuters

AstraZeneca now has a 'winning formula' for its COVID-19 vaccine, CEO says

AstraZeneca's early COVID-19 trial data not only fell short of Pfizer and Moderna's expectation-beating stats, they raised a host of questions thanks to a dosing error in one group of trial patients. But with the U.K. suffering under a new viral strain and a quick vaccine approval expected, CEO Pascal Soriot says AZ has a new "winning formula." In the company's original phase 3 trial, patients given a half dose followed by a full dose a month later were better protected than those who received two full doses. Soriot has said the company will need to conduct a new trial for U.S. authorization, but across the pond, Sky News reports a U.K. nod could come this week.
28th Dec 2020 - Fierce Pharma

Study: COVID antibodies may fend off reinfection for 6 months

Few healthcare workers in the UK who recovered from COVID-19 and had immunoglobulin G (IgG) antibodies against the virus were reinfected over the next 6 months, according to a study published in the New England Journal of Medicine. The prospective, longitudinal cohort study involved measuring levels of IgG antibodies against the coronavirus's spike protein and nucleocapsid in symptomatic and asymptomatic healthcare workers at Oxford University Hospitals undergoing COVID-19 testing. Testing began Mar 27, and follow-up ended on Nov 30.
28th Dec 2020 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 29th Dec 2020

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Healthcare workers have 7 times the risk of severe COVID-19

A new study in the journal Occupational & Environmental Medicine examines the risks that “essential” and “nonessential” British workers will develop severe COVID-19. It suggests that healthcare workers are seven times more likely to develop severe cases of COVID-19 than people with “nonessential” roles.
28th Dec 2020 - Medical News Today

The breakthrough medicines that could change the course of Covid

It remains one of the most dramatically successful outcomes in the battle against Covid-19. A cheap treatment for inflammation was found to save lives of seriously ill patients while a trio of much-touted therapies were shown to have no effect. It is now estimated that the discovery of the effectiveness of the drug dexamethasone has saved around 650,000 lives across the world, according to Professor Martin Landray, a founder of the Recovery programme – the world’s largest randomised Covid-19 drugs trial – which revealed the medicine’s anti-Covid properties last summer
28th Dec 2020 - The Guardian

Teachers and key workers 'will be added to priority list when Oxford vaccine is approved' but SAGE expert warns even a million jabs a week WON'T curb Covid crisis by February

Teachers and key workers will be added to the vaccine priority list when the Oxford University/AstraZeneca jab is finally approved as the government bids to accelerate its roll-out plans, reports say. With approval for the Oxford Covid vaccine set to come as early as today, ministers are believed to be planning to overhaul the current order, which currently focuses on the elderly, vulnerable and care home employees as well as NHS staff. But Sir Jeremy Farrar, the director of the Wellcome Trust who advises Number 10's advisory panel SAGE, warned even if Britain hits one million coronavirus vaccinations a week, it will not curb the pandemic by February.
28th Dec 2020 - Daily Mail

Expert: Stay away from 'dangerous' unauthorized COVID-19 vaccines

A health expert warns the public to "stay away" from unauthorized COVID-19 vaccines amid the supposed presence of a Chinese-developed product in the country. "To take an unapproved, unregulated vaccine is very, very dangerous," Dr. Edsel Salvana of the Department of Health Technical Advisory Group said in a media forum on Sunday. "I urge everyone to stay away from those, kasi (because) you are literally putting your life at risk if you take unregulated medicine, especially COVID vaccine." During Saturday's meeting with the Inter-Agency Task Force and other health experts, President Rodrigo Duterte claimed that "many" citizens in the country have already been injected with China's Sinopharm vaccine. The Food and Drug Administration said raids have been conducted in Makati and Binondo, adding that no arrests have been made so far.
27th Dec 2020 - CNN Philippines

100million doses of Oxford coronavirus vaccine 'to be approved this week'

The groundbreaking Oxford vaccine is expected to be approved for use within days – giving Britain a massive New Year boost in the fight against coronavirus. There is growing optimism within the Government that the Medicines and Healthcare Regulatory Agency (MHRA) will give the green light to roll out the vaccine before the end of this week. Britain has pre-ordered 100 million doses of the drug, which has been developed by Oxford University with the help of the pharma giant AstraZeneca.
27th Dec 2020 - Daily Mail

Fauci: Up to 90% of population needs vaccine for herd immunity

"We all have to be honest and humble, nobody really knows for sure, but I think 70-85% for herd immunity for COVID-19 is a reasonable estimate," he said on CNN's "State of the Union" on Sunday. Fauci had previously told The New York Times it could take up to 90% of the US population to get vaccinated to reach herd immunity against the coronavirus. He clarified that the range he states are a "guesstimate," and that the goal was for 70 to 85 percent of the population to be vaccinated. This month, the US Food and Drug Administration authorized both Moderna and Pfizer and BioNTech's coronavirus vaccine for emergency use which have been rolled out across the country.
27th Dec 2020 - Business Insider

Global report: AstraZeneca chief believes Covid vaccine will work on variant strain

The head of the firm behind the Oxford Covid vaccine has said researchers believe the jab will be effective against the variant strain of the virus that was first found in the UK. AstraZeneca chief executive, Pascal Soriot, told the Sunday Times more tests were needed to be sure, but hailed the discovery of what he called a “winning formula” to improve the vaccine’s efficacy. As Spain, Sweden and Canada joined the growing list of countries to have reported cases of the more contagious variant, Soirot said: “So far, we think the vaccine should remain effective. But we can’t be sure, so we’re going to test that.”
27th Dec 2020 - The Guardian

Ten reasons we got Covid-19 vaccines so quickly without 'cutting corners'

Long before the Covid-19 crisis, there was an awareness that a pandemic of some sort was likely in the coming years and plans had already been made to tackle it. Governments, international agencies and foundations had been pooling resources. The international Coalition for Epidemic Preparedness Innovations (CEPI) was launched in 2017, and when Covid-19 arrived they were ready. In addition, several companies and academic institutions, notably including BioNTech, Moderna and the University of Oxford, had also been working on new technologies capable of generating vaccines from the genetic codes of infectious pathogens and cancers, and testing them for several years
27th Dec 2020 - The Guardian

China's Walvax to make COVID-19 vaccine candidate similar to AstraZeneca's - media

China's Walvax Biotechnology Co has started work on a plant to manufacture an early-stage coronavirus vaccine candidate similar to AstraZeneca PLC's product, state-backed media said on Sunday. Mass production for the proposed vaccine could begin in mid-2021, with an estimated capacity of 200 million doses a year, said Health Times, a paper run by the People's Daily. The treatment is based on a chimpanzee adenovirus to deliver materials that can trigger an immune response against the virus that causes COVID-19, a technique adopted in the candidate from AstraZeneca and Oxford University. The Chinese candidate, jointly developed by China's Tsinghua University and Tianjin Medical University, has not been tested on humans. The AstraZeneca-Oxford treatment is in final-stage large trials.
27th Dec 2020 - Reuters on MSN.com

Scientists call for UK lockdown after rapid spread of Covid-19 variant

Cases of the new variant Covid-19 virus were confirmed in several European countries on Saturday, including Spain, Sweden and Switzerland. All were linked to people who had arrived from the UK. Meanwhile, Japan has announced it is banning all new entries of foreign nationals from Monday following the discovery of the variant in travellers from the UK. The news came at the same time as a further six million people in east and south-east England had tier 4 conditions, England’s strictest Covid level, imposed on them on Boxing Day. Lockdowns were also introduced in Scotland and Northern Ireland. Around 24 million people in England, more than 40% of the population, are now living in tier 4, as pressure mounts for the whole country to be put in this category.
27th Dec 2020 - The Guardian

Covid-19 pandemic will not be the last: WHO chief

WHO director-general Tedros Adhanom Ghebreyesus said it was time to learn the lessons from the Covid-19 pandemic, The novel coronavirus has killed at least 1.75 million people and nearly 80 million cases have been recorded. The coronavirus crisis will not be the last pandemic, and attempts to improve human health are "doomed" without tackling climate change and animal welfare, the World Health Organization's chief said. Tedros Adhanom Ghebreyesus also condemned the "dangerously short-sighted" cycle of throwing cash at outbreaks but doing nothing to prepare for the next one, in a video message marking Sunday's first International Day of Epidemic Preparedness.
27th Dec 2020 - Mint

Cramped housing has helped fuel spread of Covid in England – study

Overcrowded housing has helped to spread Covid-19 in England and may have increased the number of deaths, according to research by the Health Foundation. People living in cramped conditions have been more exposed to the coronavirus and were less able to reduce their risk of infection because their homes were so small, the thinktank found. Overcrowding was a key reason why poorer people and those from ethnic minority backgrounds in particular had been disproportionately affected by the pandemic, it said.
27th Dec 2020 - The Guardian

New drug could offer 'instant immunity' against Covid-19

A new drug which could offer instant immunity against Covid-19 is being trialled by British scientists, it has been reported. The antibody therapy has been developed by University College London Hospitals (UCLH) and AstraZeneca - the pharmaceutical company that has, along with Oxford University, created a vaccine that is expected to be approved for use next week. But unlike a vaccine, the new drug would be given to someone who has been exposed to the virus, preventing them from going on to develop it.
26th Dec 2020 - Kent Online

Boston doctor has severe allergic reaction to Moderna COVID vaccine: NYT

A doctor in Boston with a shellfish allergy developed a severe allergic reaction after receiving Moderna’s coronavirus vaccine on Thursday, the New York Times reported on Friday, citing the doctor. Dr. Hossein Sadrzadeh, a geriatric oncology fellow at Boston Medical Center, said he had a severe reaction almost immediately after being vaccinated, feeling dizzy and with a racing heart, the NYT reported. It is the first severe reaction publicly linked to Moderna’s vaccine, which is in its first week of a nationwide rollout.
26th Dec 2020 - Reuters UK

Oxford Covid vaccine may become the first to get Indian regulator's nod for emergency use

The process of granting emergency use approval for Bharat Biotech's 'Covaxin' may take time as its phase 3 trials are still underway, while Pfizer is yet to make a presentation, say official sources.
26th Dec 2020 - Mint

UK scientists trial drug to prevent infection that leads to Covid

British scientists are trialling a new drug that could prevent someone who has been exposed to coronavirus from going on to develop the disease Covid-19, which experts say could save many lives. The antibody therapy would confer instant immunity against the disease and could be given as an emergency treatment to hospital inpatients and care home residents to help contain outbreaks.
25th Dec 2020 - The Guardian

Brazil says Sinovac vaccine over 50% effective but delays full results

Brazilian researchers said on Wednesday the COVID-19 vaccine developed by China's Sinovac Biotech is more than 50% effective based on trial data, but again withheld full results at the company's request, raising questions about transparency. Brazil is the first country to complete a late-stage trial of the vaccine, called CoronaVac, but a release of the results, first set for early December, has now been delayed three times. The latest delay is a blow to Beijing, which has been racing to catch up with Western drugmakers, and will add to criticism that Chinese vaccine makers have lacked transparency.
24th Dec 2020 - Nikkei Asia

Another new coronavirus strain found in Nigeria: Africa CDC

Africa’s top public health official said on Thursday that a new strain of the coronavirus has been found in Nigeria, the continent’s most populous country. As The Associated Press reports, John Nkengasong, head of the Africa Centers for Disease Control and Prevention, told reporters the new strain had been identified based on two or three genetic sequences, prompting an emergency meeting of officials this week. “It’s a separate lineage from the U.K. and South Africa,” said Nkengasong. “Give us some time ... it’s still very early.”
24th Dec 2020 - The Hill

U.K. variant puts spotlight on immunocompromised patients' role in the COVID-19 pandemic

In June, Ravindra Gupta, a virologist at the University of Cambridge, heard about a cancer patient who had come into a local hospital the month before with COVID-19 and was still shedding virus. The patient was being treated for a lymphoma that had relapsed and had been given rituximab, a drug that depletes antibody-producing B cells. That made it hard for him to shake the infection with SARS-CoV-2. Gupta, who studies how resistance to HIV drugs arises, became interested in the case and helped treat the patient, who died in August, 101 days after his COVID-19 diagnosis, despite being given the antiviral drug remdesivir and two rounds of plasma from recovered patients, which contained antibodies against the virus. When Gupta studied genome sequences from the coronavirus that infected the patient, he discovered that SARS-CoV-2 had acquired several mutations that might have allowed it to elude the antibodies.
23rd Dec 2020 - Science Magazine

Coronavirus Variant Is Indeed More Transmissible, New Study Suggests

A team of British scientists released a worrying study on Wednesday of the new coronavirus variant sweeping the United Kingdom. They warned that the variant is so contagious that new control measures, including closing down schools and universities, might be necessary. Even that may not be enough, they noted, saying, “It may be necessary to greatly accelerate vaccine rollout.” Nicholas Davies, the lead author of the study, said that the model should also serve as a warning to other countries where the variant may have already spread.
23rd Dec 2020 - New York Times

Asthma-style inhaler filled with powerful LLAMA antibodies could be used to treat patients with severe COVID-19

Camelids including llamas, camels and alpacas create nanobodies These are smaller and easier to engineer by experts than human antibodies Researchers found an nanobody called NIH-CoVnb-112 which binds to viral spike They write nanoodies 'have therapeutic, preventative, and diagnostic potential'
22nd Dec 2020 - Daily Mail


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Dec 2020

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EMA recommends conditional approval for Pfizer/BioNTech's COVID-19 vaccine

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting Pfizer/BioNTech’s COVID-19 vaccine a conditional marketing authorisation (CMA) in the EU. Earlier this month, the EMA announced that it had scheduled an ‘exceptional meeting’ of the CHMP on 21 December to review additional data for the Pfizer/BioNTech vaccine. Originally, a meeting had been planned for 29 December, but was brought forward as the vaccine gained emergency approvals in the US, UK and other countries.
21st Dec 2020 - PMLiVE

CureVac set to begin phase 3 COVID-19 vaccine study in healthcare workers

CureVac is set to launch a new phase 3 study of its COVID-19 vaccine in healthcare workers at the University Medical Center Mainz in Germany. The Tübingen, Germany-headquartered company expects to vaccinate the first participant in this phase 3 study on 22 December 2020.
21st Dec 2020 - PMLiVE

EU regulator meets to discuss approval of COVID-19 vaccine

The European Medicines Agency is meeting to consider approving a coronavirus vaccine developed by BioNTech and Pfizer that would be the first to be authorized for use in the European Union
21st Dec 2020 - The Independent

Regulator clears way for use of Pfizer COVID-19 vaccine in Europe

The European Union geared up to start mass vaccinations against COVID-19 just after Christmas after the shot developed by Pfizer and its German partner BioNTech cleared regulatory hurdles on Monday. European Union countries including Germany, France, Austria and Italy have said they plan to start vaccinations from Dec. 27 as Europe tries to catch up with the United States and Britain, where inoculations began earlier this month. Having secured a green light from the European Medicines Agency (EMA), the European Commission gave final approval on Monday evening to the EU’s first COVID-19 vaccine.
21st Dec 2020 - Reuters

Inside J&J's Latam COVID vaccine trial, a rush to recruit is followed by disappointment

Earlier this month, Johnson & Johnson abruptly called for an end to enrollment in its coronavirus vaccine trial and told scientists from six Latin American countries to wrap up their work within 48 hours, two researchers told Reuters. The halt was due to J&J’s decision, announced later on that same day on Dec. 9, to cap the number of participants at about 40,000 people globally, down from a previous plan for 60,000. The drugmaker said that a surge in coronavirus cases in the areas it was testing would give it enough data to vet the vaccine.
21st Dec 2020 - Reuters

Inside Oxford's coronavirus vaccine development | Art and design

From a small discovery to producing at scale, photojournalist David Levene documents the groundbreaking work of the scientists of Oxford University during the development of a vaccine which is now poised for approval by medicines regulators
21st Dec 2020 - The Guardian

NIH to Study Allergic Reactions Linked to Covid-19 Shots

The National Institutes of Health plans to begin a clinical trial that aims to help doctors “predict and manage” allergic reactions related to Pfizer Inc.’s Covid-19 vaccine. Moncef Slaoui, chief scientific adviser to Operation Warp Speed, said during a Monday news briefing that the aim of the trial, which will also study the Moderna Inc. shot just authorized for emergency use, will be to pinpoint why the incidents, known as anaphylaxis, are occurring. During the briefing, Slaoui also addressed a new variant of the virus seen in the U.K., saying it’s no more dangerous than other strains and that there is “no hard evidence” it is more transmissible. Getting the data to determine that, he said, will take weeks.
21st Dec 2020 - Bloomberg on MSN.com

Healthcare workers who breastfeed should be offered the covid-19 vaccine

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has advised that no breastfeeding woman should receive the Pfizer-BioNTech covid-19 vaccine. NHS Trusts have interpreted this as a blanket-ban. The decision disregards an individual’s particular level of exposure to the virus or her likelihood of developing a severe form of the disease. The MHRA’s stance, and associated restrictions around pregnancy, could undermine efforts to achieve high levels of vaccination, and worsen the UK’s already low breastfeeding rates. Breastfeeding women have been excluded from the Pfizer, AstraZeneca and Moderna vaccine trials. To date, no plausible biological mechanism for how an inactivated, recombinant vaccine would cause harm to a breastfed baby has been proposed. [1] However, any data gap leaves open a possibility of risk. Yet men who are trying to conceive can be vaccinated, even though no data exists about the vaccine’s effect on spermatogenesis. Regarding lactation, theoretical risk must be weighed against the established benefits of acquiring immunity to covid-19 and of continued breastfeeding.
21st Dec 2020 - The BMJ

300 Scientists Reveal how Boris Johnson has Locked Britain into a Cycle of Draconian Lockdowns

Without a common European public health roadmap, Britain and other European nations face the prospect of another devastating third COVID-19 wave in early 2021 necessitating a cycle of repeated lockdowns, a statement published in the top British medical journal, the Lancet, signed by 300 European scientists, has warned. The statement is authored by 20 top European public health experts working at some of the most prestigious scientific institutions across Europe on solutions to the pandemic, and continues to receive new signatories from verified scientists. It confirms that, if the UK Government had followed the scientific consensus on public health responses to the pandemic, Boris Johnson could have avoided cancelling Christmas. But the statement also warns that, without a unified continental strategy, “further waves of infection are to be expected, with consequential damage to health, society, jobs, and businesses”.
21st Dec 2020 - Byline Times

Report accuses Spain of abandoning elderly during pandemic

An Amnesty International report accuses Spanish health authorities of effectively abandoning residents of nursing homes during the COVID-19 pandemic. The report says people have even been denied access to hospital care. DW's Jan-Philipp Scholz reports
21st Dec 2020 - Deutsche Welle

France says vaccine ‘should work’ against new strain of Covid

French Health Minister Olivier Veran has said that current Covid-19 vaccines should work against a new strain of the virus, believed to originate in the South East and East of England. "In theory, there is no reason to think that the vaccine should not be effective," Mr Veran told Europe 1 radio on Monday. On 19 December, Prime Minister Boris Johnson imposed lockdown measures on over 16 million people in the newly created Tier 4, which is concentrated in the East and South East of England.
21st Dec 2020 - The Independent on MSN.com

An estimation of undetected COVID cases in France

The ongoing COVID-19 pandemic has stretched health-care systems, disrupted economies and frayed the fabric of societies around the globe. Nation states have responded differently to the crisis, and only a few countries have managed to achieve continued control of coronavirus transmission. Writing in Nature, Pullano et al.1 report their study of SARS-COV-2 infections in France during late spring and early summer of 2020. Their analysis came after the peak of the first wave of COVID-19 cases there, but before the increase again in the autumn, which led to a higher second wave of cases. The results offer some important lessons.
21st Dec 2020 - Nature.com

COVID-19: Government scientist warns we 'should be very concerned' about new strain

The rapid spread of a new strain of coronavirus is the "worst news" of the pandemic so far, a government scientist has told Sky News. Britons should be "very concerned" about the mutated strain of COVID-19 that is circulating in London and the South East, Professor Andrew Hayward of the government's New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) said. Stressing the importance of how much easier this strain passes from person-to-person, he said: "This is really terrible news in terms of the pandemic. "If the vaccine is the best news, this is the worst news we've had so far, and we really, really need to tighten down the hatches to stop the spread of this strain while vaccinating as many people as possible."
21st Dec 2020 - Sky News

BioNTech confident COVID-19 vaccine effective against new UK mutation

BioNTech Chief Executive Ugur Sahin said on Monday he was confident a COVID-19 vaccine co-developed by his company would be effective against a variant of the coronavirus that has emerged in Britain. He said on Bild TV that the German company would investigate the mutation in the coming days but that he viewed the matter with “with a degree of soberness”.
21st Dec 2020 - Reuters

What you need to know about the new variant of coronavirus in the UK

Many countries have closed their borders to people leaving the UK due to the rapid spread within the country of a new variant of the coronavirus that might be more transmissible. Meanwhile, South Africa is also reporting the spread of another new variant. Here’s what you need to know. What do we know about the new UK variant so far? B.1.1.7, as it’s known, has 17 mutations compared with the original SARS-CoV-2 virus first discovered in Wuhan, China, including eight that may change the shape of the outer spike protein. Many of these mutations have been found before, but to have so many in a single virus is unusual. It was first sequenced in the UK on 20 September, but only caught the attention of scientists on 8 December, when they were looking for reasons for the rapid growth of cases in southeast England. On 14 December, the UK’s health minister, Matt Hancock, told parliament that a new variant that seems to spread faster had been identified.
21st Dec 2020 - New Scientist


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Dec 2020

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Mutant coronavirus in the United Kingdom sets off alarms but its importance remains unclear

Scientists have never seen the virus acquire more than a dozen mutations seemingly at once. They think it happened during a long infection of a single patient that allowed SARS-CoV-2 to go through an extended period of fast evolution, with multiple variants competing for advantage. One reason to be concerned, Rambaut says, is that among the 17 are eight mutations in the gene that encodes the spike protein on the viral surface, two of which are particularly worrisome. One, called N501Y, has previously been shown to increase how tightly the protein binds to the ACE2 receptor, its entry point into human cells. The other, named 69-70del, leads to the loss of two amino acids in the spike protein and has been found in viruses that eluded the immune response in some immunocompromised patients.
20th Dec 2020 - Science Magazine

FDA authorizes Moderna coronavirus vaccine for emergency use across the US

The Food and Drug Administration (FDA) has authorized a vaccine developed by Moderna and federal researchers, the second Covid-19 vaccine to receive such approval for emergency use across the US. The vaccine’s emergency authorization brings the second drug to prevent Covid-19 to the American public within a week, and millions of doses are expected to begin immediate distribution to health workers and long-term care residents. Moderna’s vaccine is 94% effective at preventing Covid-19, and is authorized in adults 18 and older. The authorization comes after it was recommended by an FDA advisory panel of independent experts.
19th Dec 2020 - The Guardian

Pfizer/Biontech COVID-19 vaccine wins Swiss regulatory approval

Switzerland will start getting doses of COVID-19 vaccine from Pfizer and partner BioNTech within days after its drugs regulator authorised use of the jabs in what officials called the world’s first approval under a standard procedure. Two months after receiving the application, Swissmedic allowed the vaccine for people aged 16 and older after a rolling review of documents being submitted. That cleared the way for an initial delivery of just over 100,000 doses, which the army will put into deep-freeze storage and send to cantons to start inoculations of vulnerable people, including the elderly and those with medical conditions.
19th Dec 2020 - Reuters

COVID-19: Moderna coronavirus vaccine approved for emergency use in the US

Moderna's coronavirus vaccine has become the second to be approved for emergency use in the US. The country's Food and Drug Administration announced the authorisation a day after the agency's panel of outside experts backed the vaccine. The FDA based its decision on results from a late-stage study of 30,000 volunteers which found that the vaccine was nearly 95% effective at preventing illness from COVID-19. The study also said there were no serious safety concerns resulting from the vaccine's use, although possible side effects include sore arms, fever, fatigue and muscle aches.
19th Dec 2020 - Sky News

BioNTech, through Fosun deal, pledges 100M coronavirus vaccine doses for China

Pfizer and its German mRNA partner BioNTech have started racking up authorizations for their COVID-19 vaccine, with shots already going into patients' arms in countries like the U.K. and the U.S. Now, BioNTech has struck a deal to supply initial doses in China, where the vaccine is currently in mid-stage testing. BioNTech, through its arrangement with local drugmaker Shanghai Fosun, will supply Mainland China with an initial 100 million doses of its mRNA vaccine, BNT162, in 2021—should the shot pass muster with domestic regulators.
19th Dec 2020 - FiercePharma

Breastfeeding mothers will not be offered Covid vaccine, say regulators

Women’s rights and breastfeeding organisations are challenging government and NHS guidance that the groups say forces mothers to choose between feeding their infants in the way that they choose and protecting themselves from Covid by being vaccinated. The NHS website advises lactating mothers to wait until they have stopped breastfeeding before having the Covid-19 vaccine. It adds: “There’s no evidence it’s unsafe if you’re pregnant or breastfeeding. But more evidence is needed before you can be offered the vaccine.” The UK government website repeats the advice, saying it was “precautionary until additional evidence is available to support the use of this vaccine in pregnancy and breastfeeding”. There have been no trials of Covid vaccines on breastfeeding women.
19th Dec 2020 - The Guardian

Experts know more about the coronavirus vaccines than any other in history, surgeon general says

Great news emerged Sunday on the vaccine front, as a second Covid-19 vaccine will soon be available to some Americans. But for much of the US, the pandemic is raging out of control -- and will get worse before everyone can be vaccinated. In just the past week, more than 18,000 people died from Covid-19 in the US. Hospitals are filling up fast. And the US set a record Friday for the most Covid-19 infections reported in one day: 249,709, according to Johns Hopkins University.
19th Dec 2020 - CNN

CDC CONFIRMS six people have suffered adverse reactions to COVID vaccine

CDC confirms at least six have had adverse reactions to COVID-19 vaccine So far, some 272,000 shots of Pfizer-BioNTech vaccine have been given in US In Alaska, three health care workers needed medical attention after getting shot In Chicago suburb, hospital stopped inoculations after four had severe reaction FDA official says allergic reactions could be due to polyethylene glycol (PEG) PEG is a chemical compound present in both Pfizer and Moderna vaccines PEG is also found in laxatives as well as creams, ointments, and solvents In industrial use, PEG is also a binding agent that can be found in antifreeze FDA insists most Americans with allergies should be safe to get the vaccine
19th Dec 2020 - Daily Mail

Fever, aches from Pfizer, Moderna jabs aren’t dangerous but may be intense for some

This summer, Luke Hutchison, a Massachusetts Institute of Technology–educated computational biologist, volunteered for a trial of Moderna’s COVID-19 vaccine. After he got the second injection, his arm immediately swelled up to the size of a “goose egg,” Hutchison says. He can’t be sure he got the vaccine and not a placebo, but within a few hours, the healthy then-43-year-old was beset by bone and muscle aches and a 38.9°C fever that felt, he says, “unbearable.” “I started shaking. I had cold and hot rushes,” he says. “I was sitting by the phone all night long thinking: ‘Should I call 911?’” Hutchison’s symptoms resolved after 12 hours. But, he says, “Nobody prepared me for the severity of this.”
18th Dec 2020 - Science Mag

More people are getting COVID-19 twice, suggesting immunity wanes quickly in some

In late June, Sanne de Jong developed nausea, shortness of breath, sore muscles, and a runny nose. At first, she thought it might be lingering effects from her COVID-19 infection in the spring. De Jong, 22, had tested positive on 17 April and suffered mild symptoms for about 2 weeks. She tested negative on 2 May—just in time to say farewell to her dying grandmother—and returned to work as a nursing intern in a hospital in Rotterdam, the Netherlands. But when her symptoms re-emerged, her doctor suggested she get tested again. “A reinfection this soon would be peculiar, but not impossible,” she told De Jong, who by then had again lost her sense of smell and had abdominal pains and diarrhea.
18th Dec 2020 - Science Mag

Moderna’s Covid-19 vaccine becomes second to receive FDA approval

The US medicines regulator has authorised the use of Moderna’s Covid-19 vaccine on an emergency basis, making a second jab available and boosting supplies at a critical crunch point as several states complain they cannot secure enough shots. The second emergency use authorisation for a Covid-19 vaccine will mean that more than 5.9m Moderna shots will be delivered in the coming week. Moderna said about 20m doses would be delivered to the US government by the end of the year. In the first quarter of next year, the company now expected to have between 100m and 125m doses available, of which 85m-100m will be in the US.
18th Dec 2020 - The Financial Times

New 'more traditional' coronavirus vaccine by Valneva to be trialled

Bristol is among a select few locations to launch clinical trials for a new coronavirus vaccine candidate. Biotech company Valneva has developed the "more traditional" vaccine in West Lothian, Scotland, and is rolling out a UK trial at four testing sites. The vaccine will initially be tested on 150 participants across Bristol, Birmingham, Newcastle and Southampton, with University Hospitals Bristol and Weston NHS Foundation Trust hosting in Bristol. It is said to be the only vaccine candidate so far to use an inactive version of the virus, and if this early phase of testing is successful, it will progress to a much larger trial involving 4,000 people from April 2021. Bristol vaccine expert Adam Finn is chief investigator for the study, and said the first vaccinations will start on Monday (December 21).
18th Dec 2020 - Bristol Live

COVID vaccine is bonanza for digital supply chain tracking industry

Logistical hurdles are a significant risk for efforts to rapidly distribute COVID-19 vaccines, but they have resulted in booming business for companies such as private California-based Cloudleaf, Germany’s SAP SE and others that sell technology for monitoring shipments from factory freezer to shot in the arm. Cloudleaf, backed by Intel Capital, the venture arm of chipmaker Intel Corp, uses sensors attached to material containers to track the location, temperature, humidity, vibration and acceleration. The sensors send data to the cloud, where an artificial intelligence algorithm can predict if action is needed to prevent a product from becoming exposed to temperatures outside the recommended range, known as excursions.
18th Dec 2020 - Reuters UK

Oxford Covid-19 vaccine 'will be approved before new year'

The Oxford AstraZeneca Covid-19 vaccine is expected to be approved before the new year with vaccination to begin from the second week in January, the Telegraph reports.
18th Dec 2020 - The Scotsman

Pharma Moderna scores FDA authorization for its COVID-19 vaccine, adding key 2nd shot as nationwide campaign ramps up

When COVID-19 began spreading earlier this year, the prospect of coronavirus vaccines launching before year’s end seemed like the longest of long shots. Now, partly in thanks to the research partnership between the federal government and industry, the U.S. has its second authorized COVID-19 vaccine. The FDA on Friday evening cleared Moderna’s mRNA vaccine, mRNA-1273, for emergency use in people 18 years and older. The authorization allows the company and federal government to immediately distribute the shot nationwide; it comes a week after Pfizer and BioNTech's emergency vaccine nod. It also adds a key second option—and more vaccine supplies—amid the United States' nationwide vaccination push. Moderna has said it should be able to distribute 20 million doses in the U.S. by the end of the year, while Pfizer has pledged 25 million doses.
18th Dec 2020 - FiercePharma

Pfizer antes up on the feds' vaccine criticism, saying Warp Speed has everything it's asked for—and more

U.S. officials took aim at Pfizer’s COVID-19 vaccine manufacturing process at a press conference Wednesday, suggesting the drugmaker had, at last, divulged production hiccups that could scupper efforts to get millions of shots into patients’ arms by year-end. But Pfizer sees things very differently—and it made those thoughts clear in a Thursday statement. “Pfizer is not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed," the drugmaker said. In fact, it said, millions of doses are sitting in warehouses, ready for shipment whenever the government calls for them. And Pfizer board member and ex-FDA chief Scott Gottlieb, M.D., pitched his take Friday morning, speculating the government may have “throttled” Pfizer’s orders to make way for a looming Moderna rollout.
18th Dec 2020 - FiercePharma

FDA authorizes Moderna COVID vaccine for emergency use

The Food and Drug Administration (FDA) last night issued an emergency use authorization (EUA) for the Moderna COVID-19 vaccine, bringing a second vaccine to the United States' battle against the pandemic and making it the first country to have two authorized vaccines that come with clear and compelling efficacy data. The formal announcement follows the Dec 17 recommendation of the FDA independent expert panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC). And it allows shipping to begin for use in people ages 18 and older. Federal officials have said they expect to ship 5.9 million Moderna doses to states next week.
18th Dec 2020 - CIDRAP

Antibody cocktail treatments show some benefit in 2 COVID studies

Two studies published yesterday in the New England Journal of Medicine discuss outcomes in COVID-19 patients given monoclonal antibody treatments, one showing that tocilizumab lowered the odds of needing mechanical ventilation and death but did not improve survival, and the other finding that REGN-COV2 lowered viral load—particularly in patients whose immune response hadn't yet been triggered or had a high viral load at baseline. Most benefit in moderate
18th Dec 2020 - CIDRAP

A side-by-side comparison of the Pfizer/BioNTech and Moderna vaccines

In an ideal world, a pandemic vaccine could be delivered in a single shot, so supplies could be stretched to cover a lot of people. It would trigger no side effect more significant than a sore arm. And it would be easy to ship and store. Unfortunately, this is not an ideal world — not yet, anyway. For now, the good news is that the United States has two Covid-19 vaccines that have been shown to be highly effective.
18th Dec 2020 - STAT News

Moderna becomes second Covid-19 vaccine to receive FDA approval

The US medicines regulator has authorised the use of Moderna’s Covid-19 vaccine on an emergency basis, making a second jab available and boosting supplies at a critical crunch point as several states complain they cannot secure enough shots. The second emergency use authorisation for a Covid-19 vaccine will mean that more than 5.9m Moderna shots will be delivered in the coming week. Moderna said about 20m doses would be delivered to the US government by the end of the year. In the first quarter of next year, the company now expected to have between 100m and 125m doses available, of which 85m-100m will be in the US.
18th Dec 2020 - The Financial Times

Fairbanks clinician is third Alaskan with adverse reaction to COVID-19 vaccine

A Fairbanks clinician suffered anaphylactic symptoms after being given the Pfizer Inc coronavirus vaccine, a hospital said on Friday, becoming the third Alaska health care worker to suffer an adverse reaction to the new drug.
18th Dec 2020 - Reuters on MSN.com

Canada regulator expects to complete Moderna COVID-19 vaccine approval in coming weeks

Canadian health regulator said it expects to complete the review on Moderna Inc's coronavirus vaccine in the coming weeks after the U.S. Food and Drug Administration approved its emergency use on Friday. "There is still information and data to be provided by Moderna for review," the regulator said in a statement. Health Canada said it cannot provide a definite timeline for the vaccine approval but expects the process to be completed in the coming weeks.
18th Dec 2020 - Reuters on MSN.com

Peter Roderick: Transparency in approving covid-19 vaccines

Transparency is generally regarded as essential for public trust in medicines, and likely to lead to better decision-making. Yet lack of transparency has been a hallmark of the regulation of medicines. Modest improvements have been made over the last decade, but the spotlight is being shone again on how the regulatory system operates as approvals are being given or considered for several covid-19 vaccines. In the US, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held live-streamed public meetings to discuss the issue generally on 22 October 2020, and specifically for the Pfizer/BioNTech vaccine, with an FDA analysis, on 10 December ahead of the FDA’s decision. That meeting voted 17/4, and one abstention, in favour of emergency use approval, which was issued the next day. A further meeting is scheduled pre-licensure for the Moderna vaccine on 17 December. As the FDA head, Stephen M. Hahn has said, “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines”.
17th Dec 2020 - The BMJ


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Dec 2020

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Early data show two doses of Oxford/AstraZeneca vaccine provoked good immune response

Oxford University’s COVID-19 vaccine candidate has a better immune response when a two full-dose regime is used rather than a full-dose followed by a half-dose booster, the university said on Thursday, citing data from early trials. The developers of the vaccine candidate, which has been licensed to pharmaceuticals company AstraZeneca, have already published later stage trial results showing higher efficacy when a half dose is followed by a full dose, compared to a two full-dose regime. However, more work needs to be done to affirm that result. The latest details from the Phase I and 2 clinical trials released on Thursday made no reference to the half-dose/full-dose regime, which Oxford has said had been “unplanned” but approved by regulators.
17th Dec 2020 - Reuters UK

Iceland’s Herd Immunity Plan Likely Impacted by Vaccine Delay

Iceland’s plan to achieve herd immunity already by the end of March will likely be impacted by production delays at Covid-19 vaccine supplier Pfizer, the country’s chief epidemiologist warned Thursday. Earlier this month, the Health Ministry said it wanted to vaccinate 75% of Icelanders born in 2005 or earlier by the end of the first quarter. But according to Thorolfiur Gudnason, that target won’t be achieved until the end of next year. “We finally have a clear picture of the vaccine shipment from Pfizer,” Gudnason said. “Because of the producers’ shortage of raw materials, the production will be delayed, so it is clear we will get less than we anticipated,” he said during a briefing in Reykjavik.
17th Dec 2020 - Bloomberg

Pfizer Says No Vaccine Shipments Have Been Delayed

Pfizer Inc. pushed back on claims it is experiencing problems producing its Covid-19 vaccine, as the company and the federal government continued to try to reach a deal that would eventually double the number of doses available for the U.S.’s vast immunization effort. Moncef Slaoui, the chief scientific adviser to Operation Warp Speed, said in an interview on Thursday that the U.S. is close to a deal for another 100 million doses of the vaccine Pfizer developed in partnership with BioNTech SE. Through the agreement, Pfizer would deliver the additional supply in the second quarter of 2021, Slaoui said.
17th Dec 2020 - Bloomberg

Pfizer says not facing production issues with COVID-19 vaccine

Pfizer Inc said on Thursday it was not facing any production issues with its COVID-19 vaccine, a day after U.S. officials pointed to challenges with the company’s manufacturing. The company said it was confident in its ability to deliver up to 50 million doses globally this year and up to 1.3 billion next year. “No shipments containing the vaccine are on hold or delayed. This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. Government to the locations specified by them,” Pfizer said in a statement.
17th Dec 2020 - Reuters

Oxford Covid-19 vaccine stimulates broad antibody and T cell functions – study

The University of Oxford’s coronavirus vaccine stimulates broad antibody and T cell responses, published trial results show. Researchers published further data from phase one/two clinical trials of the ChAdOx1 nCoV-19 Covid-19 vaccine, showing the evidence for the decision to move to a two-dose regimen in ongoing phase three trials. The data also shows how the vaccine, developed with AstraZeneca, induces broad antibody and T cell functions. Previous studies have shown that in order to develop any vaccine against SARS-CoV-2 coronavirus, two key elements of the immune system need to be activated. These are neutralising antibodies against the coronavirus spike protein which is likely to be critically important in protecting against the disease, as well as robust T cell responses.
17th Dec 2020 - The Irish News

HHS Secretary Azar says Pfizer keeps government at 'arm's length' on Covid vaccine manufacturing

Health and Human Services Secretary Alex Azar said Thursday he’d like “more visibility” into Pfizer’s Covid vaccine manufacturing, adding Pfizer has kept the federal government at “arm’s length.” Unlike other drugmakers, Pfizer did not accept federal funding to help develop or manufacture its vaccine. But Azar said he would like to see that relationship change. “We’re working with Pfizer. We’re very optimistic that we’ll secure additional quantities in the second quarter, but they’re going to need help from us on their manufacturing.”
17th Dec 2020 - CNBC

Moderna's Covid vaccine data weighed by US regulator

A panel of scientific experts has endorsed Moderna’s Covid-19 vaccine, paving the way for it to become the second jab to receive emergency authorisation for use in the US by the end of the week. All but one of the 21-member panel voted that the available evidence indicated the vaccine’s benefits outweighed its risks for people aged 18 and older, with one member abstaining. The Food and Drug Administration could announce an emergency use authorisation by the end of the week. The FDA granted the first EUA for a coronavirus vaccine to Pfizer and BioNTech last week.
17th Dec 2020 - Financial Times

COVID-19 is THE leading cause of death in the U.S., study finds

Researchers looked at daily coronavirus death rates and compared them with mortality rates of the leading causes of death from March to October 2018 Between November 1 and December 13, the seven-day rolling average for daily COVID-19 deaths tripled from 826 to 2,430. Seven-day rolling average mortality rates for heart disease and cancer are 1,700 deaths per day and 1,600 deaths per day, respectively. This means coronavirus claims 1.4 times as many lives as heart disease and 1.5 times as many as lives as cancer
17th Dec 2020 - Daily Mail

NICE: Not enough evidence to recommend vitamin D solely to prevent Covid-19

There is not enough evidence to support taking vitamin D solely to treat or prevent Covid-19, a rapid review of clinical evidence has concluded. The review, carried out by NICE, Public Health England and the Scientific Advisory Committee on Nutrition, was ordered by health secretary Matt Hancock following reports of links between vitamin D deficiency and severe Covid-19. Anticipating the results, Mr Hancock already announced that millions of vulnerable people in England would receive free supplies of Vitamin D for the winter. But the guidance, published today, advises healthcare professionals ‘not to offer vitamin D supplements to people solely to [prevent or treat] Covid-19, except as part of a clinical trial’.
17th Dec 2020 - Pulse

Devices Used In COVID-19 Treatment Can Give Errors For Patients With Dark Skin

The common fingertip devices that measures oxygen in the blood can sometimes give misleading readings in people with dark skin, according to a report Wednesday in The New England Journal of Medicine. These devices, called pulse oximeters, are increasingly finding their way into people's homes, because of the COVID-19 pandemic. So, this is not just a concern for medical personnel using professional-grade devices. Dr. Michael Sjoding and colleagues at the University of Michigan hospital in Ann Arbor came across this issue this year when they received an influx of COVID-19 patients from Detroit's overflowing hospitals. Many of these patients are Black. Sjoding noticed something odd about results from the fingertip device used throughout hospitals.
17th Dec 2020 - NPR

Chinese scientist behind Wuhan lockdown gets Nature magazine top 10 accolade

Zhang Yongzhen, publisher of the genome sequence for the pathogen, also recognised as one of the people who ‘helped shape science’ in 2020. WHO chief Tedros Adhanom Ghebreyesus, New Zealand’s Prime Minister Jacinda Ardern and America’s top infectious disease expert Anthony Fauci also honoured.
17th Dec 2020 - South China Morning Post

FDA says Pfizer coronavirus vaccine contains extra doses, expanding nation’s supply

The Food and Drug Administration said Wednesday that pharmacists can draw additional doses from vials of the Pfizer coronavirus vaccine, potentially expanding the country’s supply by millions of doses as the Trump administration negotiates with Pfizer to speed up the next round of vaccine deliveries. The government’s existing supply of the first authorized vaccine can be stretched further after pharmacists began to notice that vials contain more than the expected five doses. The FDA is in touch with Pfizer about how to handle this issue, the agency said. In the meantime, regulators say those extra doses from a single vial can be used.
17th Dec 2020 - The Washington Post

India's indigenous coronavirus vaccine 'Covaxin' shows the robust immune response in its 1st phase clinical trials

India's indigenous coronavirus vaccine, Covaxin, has shown to generate a robust immune response in its first phase clinical trials. A detailed immunogenicity response of the first phase trials of the vaccine has been declared by the manufacturers. Covaxin, jointly developed by Hyderabad based Bharat Biotech and ICMR has been found to be safe generating no serious adverse effects in people of all dose groups as per the results of the first phase clinical trials. ICMR has informed that the vaccine can be stored at 2-degree and 8-degree centigrade temperatures which also make it compatible with the National Immunization plan. Covaxin is one among the three coronavirus vaccine candidates being considered for emergency use authorisation in India by the Drug regulator. It is currently in its third and last phase of clinical trials with nearly 26 thousand volunteers in the age group of 18 and 55.
17th Dec 2020 - The Hans India

Is COVID-19 really improving pharma's reputation? Takeda survey says not so much

Thinking pharma might earn a halo with its COVID-19 work? Not so fast, Takeda says. Its recent U.K. study finds only an incremental boost in positive consumer sentiment. Only 17% of adults surveyed in October agreed that their perception of the pharma industry has improved during the pandemic, while the majority (54%) said their opinion hasn't changed. Ipsos MORI fielded the study with adults in the U.K. and also with healthcare professionals. “Whilst there might be this perception it’s improved, there’s actually a lot of work to do to get down to the general public to change their perceptions,” Jon Neal, Takeda managing director in the U.K. and Ireland, said.
17th Dec 2020 - FiercePharma

Did the FDA understaff its review of the Pfizer/BioNTech vaccine?

In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do. The FDA’s authorization last week followed similar authorizations in the United Kingdom and Canada. But the FDA’s decision is particularly important because of its reputation for being the international “gold standard” in regulatory rigor.
17th Dec 2020 - Stat News

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials: reports

Ever since Pfizer was pegged to participate in the U.S. government’s Warp Speed effort to get COVID-19 vaccines to market, the company has made it quite clear it did not need to take any federal money to develop the vaccine. But did that refusal of R&D funding contribute to Pfizer’s inability to manufacture more doses of its mRNA vaccine for the U.S. market? Pfizer could provide more than the 100 million doses it promised in its original contract with the U.S. government in the first half of next year—but only if Trump administration officials demand that suppliers of raw materials quickly fulfill the company’s orders. And CEO Albert Bourla, Ph.D., is calling on the government to use the Defense Production Act to do just that.
16th Dec 2020 - FiercePharma

BioNTech, through Fosun deal, pledges 100M coronavirus vaccine doses for China

Pfizer and its German mRNA partner BioNTech have started racking up authorizations for their COVID-19 vaccine, with shots already going into patients' arms in countries like the U.K. and the U.S. Now, BioNTech has struck a deal to supply initial doses in China, where the vaccine is currently in mid-stage testing. BioNTech, through its arrangement with local drugmaker Shanghai Fosun, will supply Mainland China with an initial 100 million doses of its mRNA vaccine, BNT162, in 2021—should the shot pass muster with domestic regulators. BioNTech will source the doses from its production facilities in Germany, the company said in a release.
16th Dec 2020 - FiercePharma

COVID 5 times deadlier than flu for hospital patients, study finds

Compared with patients with seasonal flu, hospitalized COVID-19 patients face an increased need for ventilation and intensive care, longer hospital stays, more complications, and nearly five times the risk of death, according to a US study published yesterday in BMJ. The study, led by researchers from the VA Saint Louis Health Care System, mined the US Department of Veterans Affairs medical records database to compare the outcomes of 3,641 COVID-19 patients hospitalized from Feb 1 to Jun 17 with those of 12,676 hospitalized with the flu from 2017 to 2019.
16th Dec 2020 - CIDRAP

Pfizer decision to turn off temperature sensors forced scramble to ensure Covid-19 vaccines kept ultra-cold

A last-minute snafu this fall threatened to disrupt the smooth rollout of the first Covid-19 vaccine approved in the United States, according to industry officials. At issue was how to monitor the temperature of the ultra-cold storage containers being used to distribute vials of the vaccine developed by Pfizer and its partner BioNTech. Pfizer, the officials told STAT, planned to disconnect temperature-monitoring sensors on the containers once they were delivered to health care providers — though many of the providers needed to use the boxes to store the vials for up to 30 days. Without the monitoring systems, providers would have no way of knowing if the vials had thawed prematurely, rendering the vaccine unusable.
16th Dec 2020 - Stat News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Dec 2020

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Some vaccine doses kept too cold, Pfizer having manufacturing issues, U.S. officials say

The first days of Pfizer Inc’s COVID-19 vaccine rollout have seen unexpected hitches including some vaccines being stored at excessively cold temperatures and Pfizer reporting potential challenges in its vaccine production, U.S. officials said on a Wednesday press call. At least two trays of COVID-19 vaccine doses delivered in California needed to be replaced after their storage temperatures dipped below minus 80 Celsius (minus 112 Fahrenheit), U.S. Army General Gustave Perna said on the call. Pfizer’s vaccines, made with partner BioNTech SE, are supposed to be kept at around minus 70C. Officials are investigating whether storing the vaccines at excessively cold temperatures poses a safety or efficacy risk, he said. Pfizer also has reported some production issues, U.S. Secretary of Health and Human Services Alex Azar said.
17th Dec 2020 - Reuters UK

AstraZeneca jab would speed up UK vaccine rollout - medical chief

The coronavirus vaccine developed by AstraZeneca and Oxford University would significantly accelerate the roll-out of vaccines in Britain if it is approved by regulators, the country’s Chief Medical Officer Chris Whitty said. “If AZ comes through, if there aren’t any last-minute hitches, it will speed up very substantially the period before we can actually get to the point ... when those in the highest-risk groups ... can all be vaccinated,” he told reporters.
17th Dec 2020 - Reuters UK

FDA experts back safety and efficacy of Moderna’s COVID-19 vaccine

A briefing document published by the US Food and Drug Administration (FDA) has confirmed the safety and efficacy of Moderna’s mRNA-based COVID-19 vaccine, paving the way for a potential approval soon. The document, published ahead of tomorrow's FDA’s Vaccines and Related Biological Products Advisory Committee Meeting, confirmed that the vaccine has a 94.1% efficacy rate, supporting Moderna’s own findings. The FDA analysis found that although the mRNA-1273 vaccine caused some common adverse reactions, including injection site pain, fatigue, headache, muscle/joint pain and chills, serious adverse reactions occurred in 0.2% to 9.7% of participants.
16th Dec 2020 - PMLive.com

EU fast-tracks review of Pfizer/BioNTech COVID-19 vaccine

The European Medicines Agency (EMA) has scheduled an ‘exceptional meeting’ of its Committee for Medicinal Products for Human Use (CHMP) on 21 December to review additional data for Pfizer/BioNTech’s COVID-19 vaccine. The move to bring the review forward comes after the vaccine, BNT162b2, gained approval in the US last week and earlier this month in the UK. The meeting was originally scheduled for 29 December, and the EMA added that this meeting will still take place if needed, but that the CHMP is hoping to conclude the review on 21 December, if possible.
16th Dec 2020 - PMLive.com

EU could give final approval for Pfizer COVID-19 vaccine on Dec. 23

The European Union could give final approval for the Pfizer-BioNTech COVID-19 vaccine as early as Dec. 23, a senior Commission official said on Wednesday, only two days after a possible green light from the bloc’s regulator. Under EU rules, the European Medicines Agency (EMA) recommends the approval of new medicines and vaccines, but the final decision to allow them onto the market is made by the EU executive Commission after consultation with EU governments. The EMA said on Tuesday it could issue a recommendation on the Pfizer-BioNTech vaccine on Dec. 21..
16th Dec 2020 - Reuters

Cigarette giant BAT’s coronavirus vaccine gets approval for human trials

A coronavirus vaccine being developed by cigarette giant British American Tobacco (BAT) is launching human trials after receiving regulatory approval. The UK-based manufacturer of Benson & Hedges and Lucky Strike said America’s Food and Drug Administration (FDA) has given the green light for clinical tests involving 180 adult volunteers, with results expected in the middle of 2021. The vaccine has been developed by BAT’s biotechnology division, Kentucky BioProcessing (KBP), which has previously worked on a treatment for Ebola and is also developing a seasonal flu vaccine.
16th Dec 2020 - Evening Standard

COVID-19: Valneva begins clinical trials for new coronavirus vaccine in UK

Clinical trials have begun in the UK for a new COVID-19 vaccine being developed in Scotland. The UK government has pre-ordered 60 million doses of the Valneva candidate, which is being developed at the French biotech company's facility in Livingston, West Lothian. It is being tested on 150 volunteers at four National Institute for Health Research (NIHR) testing sites in Birmingham, Bristol, Newcastle and Southampton.
16th Dec 2020 - Sky News

FDA approves first over-the-counter Covid-19 test

The US Food and Drug Administration has authorised emergency use of the first over-the-counter, self-testing Covid-19 antigen kit, which can produce results within 20 minutes. The test, which was developed by Australia's Ellume,
16th Dec 2020 - The Financial Times

An app could catch 98.5% of all Covid-19 infections. Why isn't it available?

The world wasn’t prepared for the Covid-19 pandemic – and it still isn’t. Critical shortages of personal protective equipment and ventilators continue to put medical professionals and patients at unnecessary risk. Meanwhile, long wait times for test results contribute to viral spread. Yet throughout this year, promising scientific innovations have been developed that could help reduce deaths until everyone can get the vaccine. So why aren’t they available?
16th Dec 2020 - The Guardian

Covid-19 Vaccine Trial Volunteers Note Occasional Harsh Side Effects

Jocelyn Edwards wasn’t sure she got Moderna Inc.’s experimental Covid-19 vaccine or a placebo when she received her first of two doses in August. Hours after the second shot, she said she was sure it was the genuine article. “I woke up around midnight freezing,” said the 68-year-old retired nurse. “For the next 24 hours I had intense chills, serious neck pain, headache, all my joints were aching.” She had a fever that peaked at 102.4 and poured out so much sweat that she lost 3 pounds, she said. The following day she woke up and felt fine. Ms. Edwards, like the other 30,000 volunteers who took part in Phase 3 clinical trials for Moderna’s Covid-19 vaccine, wasn’t told whether she got the vaccine or a placebo. However, she said a trial researcher attributed her symptoms to her body mounting a strong immune response to what was most likely the vaccine. “It’s better having 36 hours of feeling really rough than getting Covid,” she said.
16th Dec 2020 - The Wall Street Journal

Rapid Covid-19 home test developed in Australia approved for emergency use in US

A rapid, over-the-counter Covid-19 test developed by Australian firm Ellume has been given emergency approval in the United States. The US Food and Drug Administration (FDA) approved the Brisbane-based company’s 20-minute Covid-19 Home Test on Tuesday as the US battles the virus that has infected 16.5 million people and killed more than 300,000 people in the country. The agency approved a prescription coronavirus test last month, but an over-the-counter product will make it easier to ramp up testing.
16th Dec 2020 - The Guardian

UK medical journals call for Christmas Covid rules to be reversed

Plans to relax Covid restrictions at Christmas must be reversed or many lives risk being lost, according to a rare joint editorial from two of the UK’s most eminent medical journals. That call was echoed by the head of the hospital doctors’ union, who described the government’s plans as “kamikaze”. Keir Starmer, the Labour leader, also urged Boris Johnson to reconsider the restrictions in a letter to the prime minister on Tuesday afternoon. The British Medical Journal and Health Service Journal said the government could no longer claim to be protecting the NHS if it went ahead with its “rash” plans to allow households to mix indoors over Christmas. “We believe the government is about to blunder into another major error that will cost many lives,” it says.
16th Dec 2020 - The Guardian

A pandemic atlas: Italy becomes Europe's viral epicenter

On the morning of Feb. 20, Dr. Annalisa Malara went to work at the public hospital in tiny Codogno, Italy, and broke protocol by ordering up a coronavirus test for a patient. In so doing, she confirmed that Europe’s coronavirus outbreak was under way. Malara’s intuition — to test a 38-year-old Italian marathoner who hadn’t traveled to China or been in contact with a known positive case — sounded the alarm to Italy and the rest of the world: The virus had not only arrived in the West but was circulating locally. Italy would go on to become the epicenter of COVID-19 in Europe and a cautionary tale of what happens when a health care system in even one of the wealthiest parts of the world collapses under the weight of the pandemic sick and dead.
16th Dec 2020 - Associated Press

STUDY: 10% of Spain has been infected with COVID-19 as two Andalucia provinces revealed among least affected

Just under 10% of the Spanish population have been infected with COVID-19 since the start of the pandemic, a study has found.  The fourth round of the ENE-COVID national Serprevalence Study estimates that 4.7m people (9.9%) have already caught the disease. Around half of these were infected during the first wave and the other half during the second wave, said the report prepared by the ministry of Health, the Carlos III Health Institute and National Institute of Statistics.
16th Dec 2020 - Olive Press

Brazilian Health Regulator Says Chinese Authorities Have Not Been Transparent About Covid-19 Vaccine

China’s ‘vaccine diplomacy’ efforts hit a snag on Monday as Brazilian health regulator Anvisa said that Chinese health authorities had not been transparent about their experimental Covid-19 vaccines, one of which is currently being tested in Sao Paulo. Anvisa which is assessing the CoronaVac shot developed by China’s Sinovac Biotech said that Brazil was the “international leader” in the evaluation process for the experimental vaccine, Reuters reported. The health regulator noted that while the vaccine has had an emergency use authorization in China since June, the country’s authorities have not been transparent about the criteria used for granting this authorization.
16th Dec 2020 - Forbes

Pandemic atlas: NZ was envy of the world as nations ran the gamut in their response

The nations of the world ran the gamut in their responses to the Covid-19 pandemic — sometimes veering from strict to lax measures in the course of just a few months, and vice versa. A look at the state of the pandemic around the globe
16th Dec 2020 - 1News

COVID: WHO urges Europeans to wear masks during Christmas

Germany will begin coronavirus vaccinations on December 27 with elderly care home residents, Health Minister Jens Spahn announced Wednesday, with the European Union aiming for all 27 member states to begin on the same day. In a statement, Germany's 16 state-level health ministers said Spahn had announced "the expected approval and supply of the BioNTech vaccine" with distribution beginning shortly before year's end. As Germany holds the EU's rotating presidency, that could mean December 27 will be the start date for all member countries. Also Wednesday. French Prime Minister Jean Castex said that France could begin vaccinations "in the last week of December" if "all conditions are met".
16th Dec 2020 - Medical Express

WHO research team expected to travel to Wuhan to investigate coronavirus origin

A World Health Organization research mission to China is expected to arrive in Wuhan next month to investigate how the novel coronavirus jumped from animals to humans, and whether it emerged earlier or in a different place than originally thought. Fabian Leendertz, a biologist at Germany’s Robert Koch Institute and a member of the WHO’s 10-person mission team, told the Associated Press they will be working with Chinese scientists for four to five weeks. Most scientists think the virus Sars-Cov-2 began in animals in China, most likely bats, before jumping to humans. Cases were first discovered in the city of Wuhan in late December 2019, linked to a seafood market. More than 73.4 million people have since been diagnosed with the virus, and 1.63 million have died.
16th Dec 2020 - The Guardian

U.S. vaccine campaign grows as COVID-19 kills 2,500-plus Americans daily

The United States on Thursday expanded its campaign to deliver COVID-19 vaccine shots into the arms of doctors and nurses on the frontlines of a pandemic that has killed more than 2,500 Americans a day, even as a major winter storm threatened to slow progress on the East Coast.
16th Dec 2020 - Reuters UK

US says Pfizer vaccine production may face challenges

US officials are working with Pfizer Inc to help maximize production capacity for its COVID-19 vaccine after the drugmaker told them it may be facing production challenges, US Secretary of Health and Human Services Alex Azar said in a Wednesday press call. Pfizer did not immediately respond to a request for comment, but its Chief Executive Albert Bourla told CNBC earlier this week the company was asking the US government to use the Defense Production Act to relieve some “critical supply limitations,” particularly in some components. He did not provide further details on the areas of shortage.
16th Dec 2020 - AlJazeera

Experts propose steps to promote, distribute COVID vaccine

Two commentaries published yesterday in JAMA and a University of Michigan news release offer ideas from behavioral science and other fields to boost COVID-19 vaccine uptake in the United States and discuss the ethics of continuing placebo arms in trials of coronavirus vaccines already proven effective. The first commentary, by Kevin Volpp, MD, PhD, and Alison Buttenheim, PhD, MBA, of the University of Pennsylvania at Philadelphia, and George Loewenstein, PhD, of Carnegie Mellon University, tackled the problem of Americans' hesitancy to take a COVID-19 vaccine.
15th Dec 2020 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Dec 2020

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Britain to spend $5 billion on vaccines and bear liability, watchdog says

Britain has agreed to spend 3.7 billion pounds ($4.93 billion) on COVID-19 vaccines and in most cases will bear the liability if claims are made against the pharmaceutical firms involved, the National Audit Office (NAO) said on Wednesday. The government has agreed supply deals for 357 million doses of seven different candidate shots, but has not gone into detail about how much it has spent or indemnity agreements, citing commercial confidentiality around the contracts. The NAO said the business ministry had signed firm deals for five of the candidates, including the Pfizer/BioNTech shot which has already been approved and is being rolled out, as well as those developed by Oxford/AstraZeneca, France’s Valneva, Novavax and Moderna. Britain also has deals in principle for Sanofi/GlaxoSmithKline’s shot as well as Johnson & Johnson’s candidate.
16th Dec 2020 - Reuters UK

Valneva to start clinical trials of COVID-19 vaccine candidate in UK

French pharmaceutical firm Valneva will start the first clinical trials of its COVID-19 vaccine candidate at four sites in England, Britain’s business ministry said on Wednesday. The Phase I and Phase II trials involve 150 volunteers in Bristol, Birmingham, Southampton and Newcastle, and will be designed to show whether the vaccine is safe and produces an immune response. If these are successful, larger trials are planned for April 2021 to determine efficacy. There are four other vaccine candidates undergoing clinical trials in the United Kingdom.
16th Dec 2020 - Reuters

Peru says negotiations to secure Sinopharm vaccine 'well advanced'

Negotiations between Peru and China’s Sinopharm to purchase COVID-19 vaccines are “well advanced,” the government said on Tuesday, as the hard-hit Andean nation scrambles to lock down supplies to combat the virus. The announcement comes just days after local authorities temporarily suspended a 12,000 participant trial for the Chinese firm´s vaccine after a volunteer fell ill. The case is still under investigation. “The negotiations with ... Sinopharm are well advanced, with {only} minor details to be verified,” Peruvian Foreign Minister Elizabeth Astete told a legislative commission.
16th Dec 2020 - Reuters

Ethnic minorities more likely than Irish to get Covid-19

Ethic minorities are more likely to contract Covid-19 than white Irish people while Eastern Europeans are most likely to suffer job losses amid the pandemic, research has found. The study found that those of black or black-Irish ethnicity, Asian ethnicity, and particularly Irish Travellers were over-represented in Covid-19 cases compared with their proportion in the total population. Those of Asian ethnicity were 2.3 times as likely to contract Covid-19 as white Irish people; black people were 1.9 times as likely; and Irish Travelers 2.6 times as likely.
15th Dec 2020 - The Times

FDA Clears First At-Home, Over-the-Counter Covid-19 Test

The first Covid-19 test that can be performed entirely at home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription. While availability will be limited initially, the new test and others in development could make virus screenings as accessible as over-the-counter pregnancy tests in the U.S. for the first time. The advance follows months of criticism that the Food and Drug Administration has been too slow to approve rapid home tests for the virus. Manufactured by East Brisbane, Australia-based Ellume, the self-administered, single-use nasal swab test is small enough to fit in the palm of a person’s hand. It detects proteins on the virus’s surface in 15 minutes and delivers results to an app.
15th Dec 2020 - Bloomberg

US regulator deems Moderna’s Covid-19 vaccine ‘highly effective’

The US regulator has found Moderna’s coronavirus vaccine to be safe and “highly effective”, clearing the way for a second jab to receive emergency use authorisation later this week. The US Food and Drug Administration report on Moderna’s vaccine trials on Tuesday suggested that immunity starts about 10 days after the first of two injections, much like the one made by Pfizer and BioNTech, which received emergency use authorisation last week. A second approval could significantly expand access to Covid-19 vaccines in the US, where the pandemic has now killed more than 300,000 people, according to Johns Hopkins University data. While the US government has been offering to help Pfizer expand manufacturing capacity, it secured another pre-order for 100m Moderna vaccines last week, bringing its total to 200m.
15th Dec 2020 - The Financial Times

Why India's doctors differ on Covid-19 plasma therapy

Desperate calls for blood plasma to treat Covid-19 patients continue to appear on India's social media platforms even as doctors have mixed views about the experimental therapy. When people have Covid-19 or other viral diseases, their immune system responds by creating antibodies, which attack the virus. Over time the antibodies build up and can be found in plasma - the liquid portion of the blood. India's health authorities, like many around the world, have allowed the use of plasma to treat severely ill patients as Covid-19 continues to claim lives. The therapy also requires the consent of patients and their families.
15th Dec 2020 - BBC

New coronavirus strain spreading in U.K. has key mutations, scientists say

British scientists are trying to establish whether the rapid spread in southern England of a new variant of the virus that causes COVID-19 is linked to key mutations they have detected in the strain, they said on Tuesday. The mutations include changes to the important "spike" protein that the SARS-CoV-2 coronavirus uses to infect human cells, a group of scientists tracking the genetics of the virus said, but it is not yet clear whether these are making it more infectious. "Efforts are under way to confirm whether or not any of these mutations are contributing to increased transmission," the scientists, from the COVID-19 Genomics UK (COG-UK) Consortium, said in a statement.
15th Dec 2020 - CTV News

Covid: Christmas coronavirus rules easing 'makes no sense'

The Christmas relaxation of lockdown rules "makes no sense" as Covid-19 cases continue to rise in Wales, doctors have warned. The Welsh Intensive Care Society also wants an "urgent" lockdown across Wales before Christmas, warning critical care would be unable to cope without urgent action. It comes after the number of positive Covid-19 tests passed 100,000 in Wales. Wales' health minister Vaughan Gething has said "nothing is off the table". But Mr Gething fears people would "make up their own rules" if meeting up over Christmas was banned.
15th Dec 2020 - BBC

EU regulator brings forward Covid vaccine ruling after German pressure

The EU drug regulator has brought forward its ruling on the Pfizer/BioNTech Covid vaccine after Germany made it clear it wanted approval before Christmas. The Amsterdam-based European Medicines Agency’s announcement that it will meet on 21 December instead of 29 December to decide whether to authorise the shot followed a growing backlash from desperate EU countries, with the German health minister, Jens Spahn, saying that the agency risked losing the trust of EU citizens if it did not act fast. “The goal is to get approval before Christmas,” he told a press conference in Berlin. “We want to start vaccinating in Germany before the end of the year.” Italy’s health minister, Roberto Speranza, said he hoped the EMA “will be able to approve the Pfizer BioNTech vaccine ahead of schedule”.
15th Dec 2020 - The Guardian

Hotel quarantine ventilation may have triggered coronavirus cluster that sent SA into lockdown

South Australia's public health chief says poor ventilation, not security breaches, at an Adelaide quarantine hotel may have triggered the coronavirus cluster that sent the state into lockdown last month. Chief Public Health Officer Nicola Spurrier said a review of CCTV vision from the Peppers Waymouth Hotel found no "significant breaches of infection control". South Australia's medi-hotel system came under intense scrutiny after it was linked to the Parafield cluster, which was identified last month.
15th Dec 2020 - ABC News

New coronavirus strain spreading in UK has key mutations, scientists say

British scientists are trying to establish whether the rapid spread in southern England of a new variant of the virus that causes COVID-19 is linked to key mutations they have detected in the strain, they said on Tuesday. The mutations include changes to the important “spike” protein that the SARS-CoV-2 coronavirus uses to infect human cells, a group of scientists tracking the genetics of the virus said, but it is not yet clear whether these are making it more infectious. "Efforts are under way to confirm whether or not any of these mutations are contributing to increased transmission," the scientists, from the COVID-19 Genomics UK (COG-UK) Consortium, said in a statement
15th Dec 2020 - Reuters UK

COVID-19 cases skyrocket in Brazil with no vaccination start date

Even in the private healthcare centres, 98 percent of the COVID-19 intensive care beds had been occupied for two consecutive weeks, said the Association of Private Hospitals of Rio state. The number jumped from 81 percent to 98 percent during the first week of December. Brazilian President Jair Bolsonaro has been at odds with health officials over how to respond to the pandemic. Bolsonaro has consistently downplayed the novel coronavirus as a “little flu” and said on Thursday Brazil was at the “tail end of the pandemic”.
15th Dec 2020 - AlJazeera

Pfizer/BioNTech weren't alone: Moderna COVID-19 vaccine data targeted in EMA cyberattack

Looks like Pfizer and BioNTech’s COVID-19 vaccine was not the sole target of a recent cyberattack at the European Medicines Agency. Moderna said Monday that documents from its pre-submission discussions with EMA about its shot, mRNA-1273, were “unlawfully accessed” by hackers, citing a notification from the agency. The attackers didn't obtain personal information about trial participants, Moderna said. The company's EMA submission didn’t include any data identifying individuals in the study.
15th Dec 2020 - FiercePharma

‘I haven’t even told my wife’: Inside the frantic and secretive sprint to name the Covid-19 vaccines

The United States has a Covid-19 vaccine, the result of science carried out at breakneck speed. Now, whether the country knows it or not, it’s awaiting the results of another whirlwind effort: one to come up with brand names for products that will literally change the world. Naming a vaccine is almost always a matter of threading semantic needles, branding experts said, where the goal is to evoke positive vibes without irking the world’s ever more conservative regulatory bodies. And it takes time. The process of christening a new medicine typically involves about two years of semiotic labor. But in 2020, just as drug companies collapsed their standard development timelines to fight a global pandemic, the naming process has been condensed into a six-month sprint, said Scott Piergrossi​, president of operations and communications at the Miami-based Brand Institute, which has worked on Covid-19 vaccine naming projects. (Citing the confidentiality of client agreements, Piergrossi​ wouldn’t say which ones.)
15th Dec 2020 - Stat News

FDA scientists endorse Moderna Covid-19 vaccine, as documents provide new hints on efficacy

Scientists at the Food and Drug Administration endorsed the Covid-19 vaccine developed by Moderna as safe and efficacious on Tuesday, one day after the first doses of a competing vaccine from Pfizer and BioNTech were delivered across the United States. The FDA reviewers said that the two-dose vaccine “was highly effective” in preventing symptomatic Covid-19 from occurring “at least 14 days after the receipt of the second dose.” Vaccine-related side effects, such as aches and pains, appeared more severe than with the Pfizer/BioNTech vaccine, though such comparisons should be made with caution and are in no way expected to slow the clearance of the vaccine or present major concerns. There was also preliminary evidence that the vaccine has some efficacy after one dose, and that it prevents asymptomatic Covid-19 cases — those that occur without a person ever feeling ill
15th Dec 2020 - Stat News

Australia's initial vaccine rollout unlikely to stop Covid transmission, study finds

It is unlikely that the first generation of Covid-19 vaccines rolled out in Australia in 2021 will prevent virus transmission, making ongoing high levels of testing, strong contact tracing, isolation, and quarantine crucial, a review commissioned by the Australian Academy of Health and Medical Sciences has found. The academy comprises more than 400 senior researchers, and the review outlines steps for Australia’s pandemic response into the new year. It was authored by the director of the Marie Bashir Institute for Infectious Diseases Prof Tania Sorrell and University of Queensland immunologist Prof Ian Frazer.
14th Dec 2020 - The Guardian

BAME groups hit by Covid 'triple whammy', official UK study finds

Black and minority ethnic groups suffered a “triple whammy of threats” to their mental health, incomes and life expectancy that left them more vulnerable to the coronavirus pandemic when it took hold earlier this year, according to the UK government’s official statistics body. Research from the Office for National Statistics into the wellbeing of different ethnic groups in the UK showed that 27% of people from black backgrounds reported in April finding it difficult to make financial ends meet, compared with fewer than 10% among most white groups.
14th Dec 2020 - The Guardian

Study finds no link between COVID-19, Guillain-Barré syndrome

A large epidemiologic study in the United Kingdom today finds no association between COVID-19 and Guillain-Barré syndrome (GBS), an autoimmune condition linked to other bacterial and viral infections. GBS is a rare neurologic disease that attacks the peripheral nervous system—typically the feet, hands, and limbs—causing numbness, weakness, pain, and occasionally, fatal paralysis or permanent neurological effects. The most common trigger for GBS is infection with Campylobacter jejuni, a bacterial strain that causes gastroenteritis, or infection of the digestive tract.
14th Dec 2020 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 15th Dec 2020

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COVID-19 Changed Science Forever

In fall of 2019, exactly zero scientists were studying COVID‑19, because no one knew the disease existed. The coronavirus that causes it, SARS‑CoV‑2, had only recently jumped into humans and had been neither identified nor named. But by the end of March 2020, it had spread to more than 170 countries, sickened more than 750,000 people, and triggered the biggest pivot in the history of modern science. Thousands of researchers dropped whatever intellectual puzzles had previously consumed their curiosity and began working on the pandemic instead. In mere months, science became thoroughly COVID-ized.
14th Dec 2020 - The Atlantic

CureVac starts late-phase clinical trial of COVID-19 vaccine

CureVac has begun a phase 2b/3 clinical trial of its COVID-19 vaccine candidate CVnCoV. The study will enroll 36,500 participants in Europe and Latin America with a view to generating data to support approval of the mRNA vaccine next year. BioNTech, working with Pfizer, and Moderna have validated the concept of using mRNA to provide protection against SARS-CoV-2, rapidly delivering stellar efficacy results that set a high bar for the rest of the field. CureVac has taken a slightly different approach to mRNA vaccines, choosing to use the potency of untranslated regions to optimize the RNA rather than make chemical modifications. The approach has created a candidate that triggers immune responses at a 12-µg dose, compared to the 100 µg used by Moderna. That will enable CureVac to make more doses of the vaccine. CureVac is also aiming to trigger balanced immune responses.
14th Dec 2020 - FierceBiotech

Scientists pinpoint genes common among people with severe coronavirus infections

Certain gene variants are linked to severe coronavirus infections, according to a team of scientists in Europe who studied the genomes of 2,200 critically ill covid-19 patients. Their results provide robust support that genetic makeup plays a role in the potentially fatal illness experienced by some people infected by the coronavirus. Diving into people’s DNA is an approach that could help answer one of the pandemic’s biggest mysteries: Why do some people have mild coronavirus cases, or no symptoms at all, while others rapidly fall ill and die? Evidence is clear that older age and underlying conditions are risk factors for increased covid-19 severity. But genetic predispositions to runaway inflammation or other harmful immune responses could also contribute to worse disease.
14th Dec 2020 - The Washington Post

Covid: How different ethnic groups have been affected by the pandemic

Most people in the UK have said they experienced a worsening of their mental health between 2019 and April 2020, according to the Office for National Statistics (ONS). The ONS has analysed data from different ethnic groups in the UK just before the Covid-19 pandemic and in April this year, when the UK was in a full national lockdown. Data from the ONS reveals most ethnic groups have suffered in society in the past year - whether that is financially or mentally - through stress or lack of sleep and loneliness.
14th Dec 2020 - ITV News

Why many countries failed at COVID contact-tracing — but some got it right

Across the Western world, countries have floundered with this most basic public-health procedure. In England, tracers fail to get in touch with one in eight people who test positive for COVID-19; 18% of those who are reached provide no details for close contacts. In some regions of the United States, more than half of people who test positive provide no details of contacts when asked. These statistics come not from the first wave of COVID-19, but from November, long after initial lockdowns gave countries time to develop better contact-tracing systems. The reasons for the failures are complex and systemic. Antiquated technology and underfunded health-care systems have proved ill-equipped to respond. Wealthy nations have struggled to hire enough contact-tracers, marshal them efficiently or make sure that people do self-isolate when infected or that they quarantine when a close contact has the disease. And overstretched contact-tracers have been met with distrust by people wary both of health authorities and of the technologies being deployed to fight the pandemic. Meanwhile, researchers who are keen to draw lessons from contact-tracing operations are stymied by a dearth of data.
14th Dec 2020 - Nature.com

CSL 'optimistic' on vaccine delivery as AstraZeneca provides data to regulators

CSL's chief scientific officer Andrew Nash says Australia has a range of options in place when it comes to COVID vaccines even if the Oxford/AstraZeneca project were to hit regulatory hurdles. The axing of the local University of Queensland vaccine candidate last Friday puts the ASX-listed biotech's focus squarely on the Oxford/AstraZeneca vaccine, for which it has committed to make 50 million doses. While CSL has started the production process it must wait for AstraZeneca to secure regulatory approval of the product before it can be deployed.
14th Dec 2020 - The Sydney Morning Herald

Almost 50 Brits to be given experimental nasal spray Covid-19 vaccine next month

New York company Codagenix said human studies to begin first week of January Codagenix says its computer-edited virus is 1,000 times slower than real thing Given via a nasal spray, in the same way the influenza jab is given to children
14th Dec 2020 - Daily Mail

'I will not be the test dummy': Nursing home residents and staff are reluctant to get COVID vaccine

US nursing home residents account for nearly 40% of nation's death toll Some families and nurses fear those in 'fragile health' could be put at risk by the Pfizer/BioNTech vaccine, and claim it has been 'rushed.' 'I will not be the test dummy,' said one respondent to survey by National Association of Health Care Assistants. Others are keen for 'light at the end of the tunnel' that could allow them to rejoin children and grandchildren. In on-going study of 44,000 people, U.S. Food and Drug Administration found vaccine safe and more than 90% effective, including the elderly. Experts say 70% of the population need to receive vaccine for it to be successful. Some experts blame Trump administration for undermining faith in science. Authorities are investigating reports in UK of several health workers with a history of severe allergies suffering from side effects after receiving the vaccine
14th Dec 2020 - Daily Mail

Moderna will ship nearly 6 million doses of its coronavirus vaccine as soon as it gets FDA approval

Moderna Inc's first shipment of its coronavirus vaccine to the U.S. will include nearly six million doses. The jabs will be sent to 3,285 locations across the country via FedEx and UPS. In a briefing on Monday, Gen Gustave Perna said a reserve has been set aside, but he didn't disclose the exact amount, The FDA's advisory committee will meet on Thursday to discuss whether or not recommend approving Moderna's vaccine. If approved this week, the first Americans will likely not get immunized before December 21
14th Dec 2020 - Daily Mail


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 14th Dec 2020

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Pfizer’s Covid-19 Vaccine: Distribution, Side Effects and Everything You Need to Know

Pfizer Inc. and partner BioNTech SE received authorization from the Food and Drug Administration on Friday to begin distributing their Covid-19 vaccine. As the shot goes into use across the U.S., here’s what we know and don’t know. Who is authorized to receive the vaccine? The FDA authorized the vaccine to be administered to people 16 and older to prevent Covid-19.
13th Dec 2020 - The Wall Street Journal

Bahrain approves Chinese COVID-19 vaccine for use

Bahrain said Sunday it approved the use of a Chinese coronavirus vaccine, following its earlier approval of a vaccine made by Pfizer and its German partner BioNTech. Separately, Kuwait has granted emergency use for the Pfizer vaccine. Bahrain's state-run news agency said the Sinopharm vaccine would be available in the island kingdom off the coast of Saudi Arabia in the Persian Gulf. It offered few details though on study results of the vaccine, in line with the United Arab Emirates, which last week announced the vaccine was 86% effective.
13th Dec 2020 - ABC News

Covid vaccine: Four Pfizer trial participants developed facial paralysis, FDA says

New documents have revealed that four participants in the Pfizer coronavirus vaccine trial developed Bell's palsy - a condition that causes a temporary weakness or paralysis of the muscles in the face. The patients were taking part in the US vaccine trial, which included 38,000 participants. The Bell’s palsy is believed to be unrelated to the vaccine, with cases in the trial occurring at the same rate as in the general population. A document by the FDA said: “Among non-serious unsolicited adverse events, there was a numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group, though the four cases in the vaccine group do not represent a frequency above that expected in the general population.”
13th Dec 2020 - The Mirror on MSN.com

Fears over safety of Chinese coronavirus vaccines

China has already vaccinated more than a million people, even though its experimental vaccines have yet to be proven to work — or be safe. It has done this by offering vaccines that are still in their testing stage for emergency use. Initially, they were given to employees of state-owned enterprises who were being sent abroad, and frontline healthcare workers. In October, clinics in one province began allowing people to register and receive an unapproved vaccine at a cost of £46 for a double dose. People were reported to have travelled hundreds of miles for a shot at immunity. China has been doing all this without official regulatory approval. Instead, it has given people experimental vaccines under an emergency programme launched in July. This approach runs counter to that of many western countries, where experts have said that complete testing is necessary. Furthermore, Chinese companies have not released any data on their vaccines’ safety or efficacy.
12th Dec 2020 - The Times

Mexico approves emergency use of Pfizer coronavirus vaccine

The Mexican government’s medical safety commission approved the emergency use of the Pfizer-BioNTech coronavirus vaccine Friday, making Mexico the fourth country to do so. Assistant Health Secretary Hugo López-Gatell said Mexico's approval came after Britain, Canada and Bahrain. Mexico is set to receive 250,000 doses of the vaccine, enough for 125,000 people, because each person requires two shots. López-Gatell has said that front-line health workers will get the shots first.
12th Dec 2020 - The Independent

Coronavirus: Where to get the COVID-19 Sinopharm vaccine in the UAE

The United Arab Emirates released a list on Friday of all the locations where residents and nationals can receive the Sinopharm COVID-19 vaccine. Residents across the UAE will now be able to volunteer to be vaccinated, after Abu Dhabi’s voluntary vaccination campaign was extended to include Dubai and the UAE’s five other emirates this week. The vaccine, which was developed by China’s state-owned Sinopharm, was approved after it showed 86 percent efficacy in trials, according to regulators.
12th Dec 2020 - AlArabiya

U.S. FDA authorizes Pfizer COVID-19 vaccine for emergency use

The U.S. Food and Drug Administration said it authorized the use of Pfizer Inc's COVID-19 vaccine on Friday, with the first inoculations expected within days, marking a turning point in the United States where the pandemic has killed more than 292,
12th Dec 2020 - Reuters

Coronavirus vaccine: Minority groups and the very ill given priority

GPs who run short of vaccine for patients aged over 80 have been told to prioritise elderly people from ethnic minorities and those who have severe underlying health conditions. The first vaccines are set to be given by GPs on Tuesday from about 280 sites. They have been told to start contacting patients, who can expect to hear about appointments today and tomorrow. However, there is concern that dozens of practices have opted out of the programme, citing a lack of resources and fears that other patient care might be affected by the focus on Covid-19. In NHS guidance, those not taking part have been told to co-operate with local health chiefs to ensure their patients still have access to the vaccine.
12th Dec 2020 - The Times

GSK/Sanofi Covid vaccine delayed until end of next year

A coronavirus vaccine being developed by GlaxoSmithKline and its French partner, Sanofi, will be delayed until the end of next year after trials revealed it failed to produce a strong immune response in older people. The drug companies hoped to have regulatory approval for the candidate vaccine in the first half of 2021, but interim results from a phase 1/2 trial showed an “insufficient” response in the over-50s, the age group most vulnerable to severe Covid-19. The results released on Friday are a stark reminder that despite a flurry of positive results from vaccines produced by Pfizer/BioNTech, NIH/Moderna and Oxford University/AstraZeneca, developing effective vaccines at speed is no simple task.
12th Dec 2020 - The Guardian

J&J cuts size of Covid-19 vaccine study due to prevalence of disease

Johnson & Johnson is cutting the size of its pivotal U.S. Covid-19 vaccine trial — the only major study testing a single dose of a Covid vaccine — from 60,000 volunteers to 40,000 volunteers. The change is being made possible by the fact that Covid-19 is so pervasive across the country, according to a person familiar with the matter. The more virus there is in the U.S., the more likely it is that participants will be exposed to it, meaning researchers will be able to reach conclusions based on a smaller trial. Changing the size of the study does not indicate that results will come on a different timetable, or anything about whether they will be positive or negative
12th Dec 2020 - STAT

Engineers develop mini Covid vaccine factory that can create 30,000 doses a day

British engineers have invented a miniature Covid-19 vaccine factory that can make 30,000 doses a day. Experts at King’s College London designed it to manufacture vaccines such as the Pfizer/BioNTech inoculation. It could end the logistical problems of delivering the frozen vaccine from factories on the continent to UK communities. Plans are on track to submit the game-changing “factory in a box” technology for regulatory approval by as early as March. It is estimated that 60 of the devices could make enough doses to immunise the nation in a matter of weeks. The innovative machine was designed by Professor Makatsoris Harris.
12th Dec 2020 - Mirror Online

Oxford Covid vaccine could leave people unprotected despite being vaccinated, expert warns

With coronavirus cases around the world now at over 68 million, scientists have been working around the clock to develop a vaccine. A vaccine developed at the University of Oxford was initially tipped as the front runner in the fight against Covid-19. Yesterday, the results of the Oxford vaccine’s Phase III trial were announced, showing an overall vaccine efficacy of 70.4%. However, the efficacy was found it increase to 90% when participants were given a low first dose, followed by a larger second dose of the vaccine. While this suggests that giving a low first dose could be the best way to roll out the vaccine, one expert has warned that this tactic runs the risk of leaving people unprotected between doses.
12th Dec 2020 - Mirror Online

Boston Biogen conference of 175 people led to 300,000 infections across the world

A strategy meeting of 175 senior managers at Biogen Inc was held at the Boston Marriott Long Wharf Hotel in late February. In a recent study of 772 patients, researchers found one distinct strain in more than one-third of patients linked back to the conference. The strain was found in at least 29 states, including Florida, North Carolina and Indiana, and countries such as Australia, Slovakia, Sweden At least 99 people at the meeting tested positive for COVID-19 and researchers now believe the conference is responsible for up to 330,000 global infections
11th Dec 2020 - Daily Mail

Five key genes linked to severe COVID-19 found, suggesting drug targets

Five key genes are linked with the most severe form of COVID-19, scientists said on Friday, in research that also pointed to several existing drugs that could be repurposed to treat people who risk getting critically ill with the pandemic disease. Researchers who studied the DNA of 2,700 COVID-19 patients in 208 intensive care units across Britain found that five genes involving in two molecular processes - antiviral immunity and lung inflammation - were central to many severe cases. “Our results immediately highlight which drugs should be at the top of the list for clinical testing,” said Kenneth Baillie, an academic consultant in critical care medicine at Edinburgh University who co-led the research.
11th Dec 2020 - Reuters

Nigeria warned of possible new COVID-19 wave, authorities eye vaccine in early 2021

Nigeria may be on the verge of a second wave of COVID-19 infections, the health minister warned on Thursday, as another official said the country expects to roll out a vaccine by April next year. Osagie Ehanire, speaking at a news conference in the capital Abuja, said 1,843 cases were recorded last week compared with 1,235 two weeks before that. “We may just be on the verge of a second wave of this pandemic,” he said. His comments came a day after South Africa said it had officially entered a second wave.
11th Dec 2020 - Reuters

Covid: Trials to test combination of Oxford and Sputnik vaccines

UK and Russian scientists are teaming up to trial a combination of the Oxford-AstraZeneca and Sputnik V vaccines to see if protection against Covid-19 can be improved. Mixing two similar vaccines could lead to a better immune response in people. The trials, to be held in Russia, will involve over-18s, although it's not clear how many people will be involved. Oxford recently published results showing their jab was safe and effective in trials on people. The researchers are still collecting data on the effectiveness of the vaccine in older age groups while waiting for approval from the UK regulator, the MHRA. AstraZeneca said it was exploring combinations of different adenovirus vaccines to find out whether mixing them leads to a better immune response and, therefore, greater protection.
11th Dec 2020 - BBC

Sanofi suffers major setback in development of a Covid-19 vaccine

One of the world’s leading vaccine manufacturers has suffered a major setback in its work to produce a Covid-19 vaccine. The problem will push the timeline for deployment of Sanofi Pasteur’s vaccine — if it is approved — from the first half of 2021 into the second half of the year, the company said Friday. The news is not just disappointing for Sanofi and its development partner, GlaxoSmithKline, which is providing an adjuvant used in the vaccine. The companies have contracts with multiple countries, including the United States and Britain, as well as the European Union. Sanofi had hoped to start a Phase 3 trial of the vaccine this month and had projected it could produce 100 million doses of vaccine in 2020, and 1 billion doses in 2021.
11th Dec 2020 - STAT

World Trade council fails to act on proposal to waive IP rights to Covid-19 drugs and vaccines

In a widely anticipated meeting, a World Trade Organization council failed to act on a controversial proposal to temporarily waive some provisions in a trade agreement governing intellectual property rights, which would make Covid-19 medical products more easily accessible, especially by low-income countries. During the closed-door session, which took place on Thursday, several wealthy nations reiterated arguments that patent rights do not create barriers to wider access and affordability. The U.S., for instance, suggested a more targeted approach in which a license could be granted to a generic manufacturer to make a specific product for distribution in certain countries.
11th Dec 2020 - STAT

US offers to help increase production of Pfizer/BioNTech Covid vaccine

The US government is offering to help increase production of the Pfizer/BioNTech Covid-19 vaccine, as it tries to secure another 100m doses of the jab that regulators are reviewing. Operation Warp Speed, the government programme to accelerate the development of a vaccine, is trying to double its pre-order of doses, after soaring demand has led to a shortage, according to people familiar with the matter. Operation Warp Speed is trying to help Pfizer obtain more raw materials and equipment under the Defense Production Act to ensure it can produce the extra doses by June 2021, according to one of the people.
11th Dec 2020 - Financial Times

Australia Scraps Covid-19 Vaccine That Produced H.I.V. False Positives

Australia on Friday canceled a roughly $750 million plan for a large order of a locally developed coronavirus vaccine after the inoculation produced false positive test results for H.I.V. in some volunteers participating in a trial study. Of the dozens of coronavirus vaccines being tested worldwide, the Australian one was the first to be abandoned. While its developers said the experimental vaccine had appeared to be safe and effective, the false positives risked undermining trust in the effort to vaccinate the public. Prime Minister Scott Morrison on Friday said that his government would compensate for the loss of 51 million doses it had planned to buy from the Australian consortium in part by increasing orders of vaccines made by AstraZeneca and Novavax. The government has said it plans to begin inoculating citizens by March
11th Dec 2020 - The New York Times

Peru suspends Sinopharm COVID-19 vaccine trial after 'adverse event'

Peru suspended trials for China’s Sinopharm COVID-19 vaccine due to a “serious adverse event” that occurred with one of the volunteers for the study, the Peruvian government said in a statement on Saturday. The health ministry said the event is “under investigation to determine if it is related to the vaccine or if there is another explanation.”
11th Dec 2020 - Canoe.com

Covid vaccine: GlaxoSmithKline's jab found to be ineffective in huge blow for British firm

An experimental Covid-19 vaccine developed by Britain's GlaxoSmithKline and Sanofi has been found to show an 'insufficient immune response' in clinical trial results, in a blow to efforts to fight the pandemic. The two companies said they planned to launch another study next year, hoping to come up with a more effective vaccine by the end of 2021. The results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults. Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur, said: “We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data.
11th Dec 2020 - Mirror Online

No cases of allergic reactions recorded during Pfizer's COVID-19 vaccine trial - company executive

There were no cases of severe allergic reactions to Pfizer Inc and partner BioNTech SE’s COVID-19 vaccine candidate during clinical trials, a Pfizer executive said at a regulatory conference on Friday. A late-stage trial testing the potential vaccine excluded participants who had a prior history of severe allergic reactions to any vaccine or to the constituents of Pfizer/BioNTech vaccine, said Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development. “We’ve not had any anaphylactic episodes related to the vaccine,” Gruber said during a panel meeting of independent advisers to the U.S. Centers for Disease Control and Prevention.
11th Dec 2020 - Reuters

F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away

The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days. The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.
11th Dec 2020 - The New York Times

Covid vaccine: GlaxoSmithKline's jab found to be ineffective in huge blow for British firm

An experimental Covid-19 vaccine developed by Britain's GlaxoSmithKline and Sanofi has been found to show an 'insufficient immune response' in clinical trial results, in a blow to efforts to fight the pandemic. The two companies said they planned to launch another study next year, hoping to come up with a more effective vaccine by the end of 2021. The results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults. Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur, said: “We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data.
11th Dec 2020 - MSN.com

AstraZeneca to trial combination with Russian COVID-19 vaccine

Pharmaceutical giant AstraZeneca’s Russian branch has said it would use part of Russia’s homemade Sputnik V vaccine in further clinical trials, a major sign of recognition for a jab that has been viewed with scepticism by the West. Russia was one of the first countries to announce the development of a coronavirus vaccine, which it named Sputnik V after the Soviet-era satellite. While the jab is yet to complete its third and final phase of testing involving some 40,000 volunteers, its developers have said interim trial results showed 95 percent efficacy. “Today we announce a clinical trial programme to assess the safety and immunogenicity of a combination of AZD1222, developed by AstraZeneca and Oxford University, and Sputnik V, developed by Russian Gamaleya Research institute,” AstraZeneca said in a statement published on its website in English and Russian on Friday.
11th Dec 2020 - AlJazeera

Growing concerns over COVID-19 vaccine distribution

There are growing concerns that African countries won't receive enough doses and that there is not enough capacity for a roll-out. This is despite the WHO's COVAX initiative to ensure access of lower income countries like Malawi to COVID-19 vaccines.
10th Dec 2020 - Deutsche Welle

Oxford COVID-vaccine paper highlights lingering unknowns about results

The first formally published results from a large clinical trial of a COVID-19 vaccine — which scientists hope could be among the cheapest and easiest to distribute around the world — suggest that the vaccine is safe and effective. But the data also highlight a number of lingering unknowns, including questions about the most effective dosing regimen and how well it works in older adults. The vaccine, developed by the University of Oxford, UK, and the pharmaceutical firm AstraZeneca in Cambridge, UK, has been closely watched, in part because it is likely to be simpler to distribute than the two RNA-based vaccines from companies Pfizer and Moderna, which need to be stored at low temperatures. The Oxford team is also now the first of these three leading COVID-vaccine developers to publish results from its phase III trials in a peer-reviewed journal — so far, the findings have been disseminated only through press releases.
8th Dec 2020 - Nature.com

Ultra-cold freezing presents next challenge in Covid vaccine race

Demand for ultra-cold storage freezers has spiked as governments and manufacturers prepare to ship Covid-19 vaccines around the world and along the so-called last mile to those most vulnerable to the disease. Unique characteristics of the two leading Covid-19 vaccines mean they both have to be transported frozen. The shot developed by US biotech Moderna, currently under regulatory review in the US and the EU, can survive for six months at minus 20C, the temperature of a standard domestic freezer. The vaccine developed by Pfizer and Germany’s BioNTech, approved for use in the UK this month, must, in contrast, be transported at minus 70C.
7th Dec 2020 - Financial Times


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 11th Dec 2020

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Biogen conference in Boston likely linked to 330,000 COVID-19 cases worldwide, researchers say

It likely took just one of the 175 people gathered in February at a Biogen conference at the Boston Marriott Long Wharf hotel to ignite a COVID-19 wildfire. Within a week, attendees began falling ill. More than 99 would ultimately test positive. By then, many of them had hopped aboard planes to head home or even attend other conferences. And the spread only exploded from there. Researchers now believe roughly 330,000 COVID-19 cases across the nation and around the world can be traced back to the two-day Boston conference, according to a new study published Thursday in the journal Science. The study estimates some 96,360 of the cases with a genetic link to the Biogen conference were discovered in Florida, several hundred miles from the waterfront lobby and banquet rooms in Boston that served as the perfect incubator for an eager virus to multiply.
11th Dec 2020 - The Boston Globe on MSN.com

How does Oxford University’s coronavirus vaccine work and how is it different to Pfizer and Moderna’s?

Results showing the effectiveness of the University of Oxford's coronavirus vaccine are expected to be released in the coming weeks. In the meantime, phase two trial data released on Thursday suggested the jab produces a strong immune response in older adults. And according to the researchers, volunteers in the trial demonstrated similar immune responses across all three age groups (18-55, 56-69, and 70 and over).
10th Dec 2020 - Evening Standard

Moderna begins study of COVID-19 vaccine in adolescents

Moderna Inc said on Thursday it had dosed the first participants in a mid-to-late stage study testing its COVID-19 vaccine candidate in adolescents aged 12 to less than 18, and aims for data ahead of the 2021 school year. The trial will enroll 3,000 healthy participants in the United States and will assess the safety and effectiveness of two doses of the company’s vaccine candidate, mRNA-1273, given 28 days apart. Moderna has submitted applications seeking emergency use authorization (EUA) in the United States and EU after full results from a late-stage study showed the vaccine was 94.1% effective in adults with no serious safety concerns. Rival Pfizer/BioNTech have also sought EUA after their coronavirus vaccine’s two-dose regimen proved 95% effective against COVID-19 and had no major safety issues.
10th Dec 2020 - PharmaLive

COVID-19 vaccine not advised for women who are pregnant or breastfeeding

The new Pfizer-BioNTech COVID-19 vaccine has “not yet been assessed in pregnancy”, according to Public Health England.
10th Dec 2020 - The News Letter

Brazil health regulator sets rules for COVID-19 vaccine emergency use

Brazil’s health regulator Anvisa decided on Thursday to allow temporary emergency use authorizations for COVID-19 vaccines and set rules for companies to apply for the option that did not exist in the country now facing the world’s third worst coronavirus outbreak. The decision will potentially allow emergency use of vaccines that are being tested in Brazil by AstraZeneca, Pfizer Inc, Johnson & Johnson’s pharmaceutical subsidiary Janssen, and China’s Sinovac Biotech.
10th Dec 2020 - Reuters

Coronavirus vaccine: Expert addresses Warfarin concerns

Patients who take blood thinning drugs for heart problems have been reassured that the Covid-19 vaccine should not cause adverse effects if their condition is stable. Anti-coagulant treatments including Warfarin are prescribed to patients at increased risk of strokes or those who have a metal heart valve or those with conditions including Atrial Fibrillation. Like most vaccines, the coronavirus vaccine is injected into the muscle of the upper arm and may bleedmore than injections that are given under the skin but less than those that are administered into a vein.
10th Dec 2020 - heraldscotland.com

U.S. FDA advisory panel meets on Pfizer's coronavirus vaccine

Pfizer Inc said on Thursday it planned to file for full U.S. approval of its experimental coronavirus vaccine by April next year, even as the vaccine awaits emergency use authorization by the U.S. Food and Drug Administration. The remarks were made by Pfizer executive William Gruber at a meeting of independent U.S. FDA advisers that are weighing emergency authorization of the vaccine made by Pfizer and German partner BioNTech SE.
10th Dec 2020 - Reuters

Saudi registers Pfizer COVID-19 vaccine for import, use - SPA

Health authorities in Saudi Arabia have registered the Pfizer-BioNTech COVID-19 vaccine for import and use in the country, state news agency SPA said on Thursday. Saudi Arabia’s Food and Drug Agency registered the vaccine. Procedures necessary for its import and use will begin, the statement said.
10th Dec 2020 - Reuters

Nigeria Plans to Approve Covid-19 Vaccine Early Next Year

Nigeria expects to license by April one of the vaccines under development globally for Covid-19, the West African nation’s drugs regulator said. “We are looking at the end of the first quarter of next year or the beginning of the second quarter” to approve a shot for use in Nigeria, National Agency for Food and Drug Administration and Control Director-General Mojisola Adeyeye said in an interview on Wednesday.
10th Dec 2020 - Bloomberg

The Coronavirus Vaccines Were Developed in Record Speed. Now, the Hard Part.

Dr. Walensky’s study found that the most important factor in a given vaccine’s success is not necessarily how well that vaccine works. It’s everything else: how quickly and strategically the vaccine is distributed across the country, how well received it is and whether people continue to abide by other edicts, like mask wearing and physical distancing. “We find that factors related to implementation will contribute more to the success of vaccination programs than a vaccine’s efficacy as determined in clinical trials,” Dr. Walensky and her co-authors wrote.
10th Dec 2020 - The New York Times

EU regulator rejects need for emergency authorization of coronavirus vaccine

The head of the European Medicines Agency is standing by the EU's decision to wait for a conditional marketing authorization (CMA) before using coronavirus vaccines on the public. "While speed is of the essence, safety is our No. 1 priority," Emer Cooke, the agency's new executive director, told the European Parliament's health committee today. "These vaccines will be given to millions of people in the EU, and we are keenly aware of the huge responsibility we have to get these recommendations right to protect the European population." She noted the agency is "aware of" the decisions by the U.K. and Canada to approve the BioNTech/Pfizer vaccine with the faster process of an emergency authorization. The U.S. could follow suit later today.
10th Dec 2020 - POLITICO.eu

Covid vaccine from China's Sinopharm is 86% effective, says UAE

The United Arab Emirates, the first foreign country to approve a Covid-19 vaccine developed by Chinese state-owned pharmaceutical group Sinopharm, said it had 86 per cent efficacy, according to interim results of a phase 3 trial. The announcement is a boost for Beijing’s ambitions to establish its pharmaceutical companies as global leaders in developing and distributing vaccines and comes after the release of final stage results from western frontrunners Pfizer/BioNTech, Moderna and AstraZeneca/Oxford. Chinese developers were forced to carry out phase 3 trials overseas because the virus is now almost fully under control in China.
10th Dec 2020 - Financial Times

Novavax Covid vaccine trial recruits in Oxfordshire

People in Oxfordshire are among volunteers recruited for another promising Covid vaccine. US biotech company Novavax is running trials in Oxford as part of more than 15,203 participants recruited across the UK. It is the largest double blind, placebo-controlled Covid-19 vaccine trial to be undertaken in the country so far. It comes as the first Pfizer vaccinations against coronavirus were carried out in the city this week and new analysis of the Oxford University candidate showed it was 'safe and effective'.
10th Dec 2020 - Oxford Mail

Three groups of people urged to avoid the coronavirus vaccine

Three types of people who have been urged not to have the coronavirus vaccine have been revealed as hospital innoculations continue. The news of three groups unable to be vaccinated come as England's Chief Medical Officer attempts to dispel anti-vax myths. Professor Chris Whitty has said he will take any Covid-19 vaccine offered to him, adding it is a "society" and "political" decision as to when restrictions are lifted. England's chief medical officer told MPs he would be keen to have a jab to protect himself, as the NHS vaccination programme continues across the UK.
10th Dec 2020 - Birmingham Post

Even people with moderate cases of Covid-19 can suffer STROKES and seizures, study suggests

Moderate cases of Covid-19 which do not require treatment in intensive care can still lead to strokes and seizures, according to a new study. Researchers looked at the cases of 921 people who were admitted to a hospital in Boston, Massachusetts, between April and July. Seventy-four had both Covid-19 and also underwent a neurologic examination. The study reveals symptoms such as stroke and seizures as well as inflammation may be more common than previously believed, irrespective of Covid-19 severity.
10th Dec 2020 - Daily Mail on MSN.com

Covid-19: The mask-wearing US city that bucked the trend

A major factor in the decision was keeping the university - South Dakota State - open for teaching and therefore retaining the large student population during the autumn, adds Mr McMacken. The requirements for mask use were brought in by the city of Brookings but they don't apply across the entire county of the same name. Our data is for the county, not the city, so it has its limitations. Brookings County now has the lowest infection rate out of the five most populous South Dakota counties.
10th Dec 2020 - BBC

Could England have avoided second lockdown by sticking to tiers?

ENGLAND didn’t need a second lockdown because daily covid-19 cases were already peaking under previously imposed regional restrictions, according to a researcher leading a popular symptom-tracking app. “It was unnecessary, if you looked at the latest data on the curves,” says Tim Spector at King’s College London, who oversees the Covid Symptom Study. Other researchers disagree, however....
10th Dec 2020 - New Scientist

Air pollution roars back in parts of UK, raising Covid fears

Air pollution in many towns and cities across the UK now exceeds pre-pandemic levels, exacerbating the risk of Covid-19 and putting the health of millions of people at risk. A study published on Thursday says that although air quality improved dramatically in the first half of the year as the country went into lockdown, pollution now meets or exceeds pre-Covid levels in 80% of the 49 cities and large towns that were analysed. There is growing evidence that exposure to toxic air increases the risks from Covid-19 and the authors of the study say their findings underscore the need for local councils to do more to reduce car use and improve air quality by prioritising walking and cycling.
10th Dec 2020 - The Guardian

New study shows boy, 4, had Covid in Italy in November 2019

Researchers say an Italian boy tested positive for coronavirus in November 2019 – a revelation which has dramatic implications for the timeline of when the virus was spreading. The Covid-19 outbreak was first reported in Wuhan, China, in December last year – although Chinese authorities now admit there were cases dating back to November, amid global scepticism about whether the country has been open about what it knew and when. The study in Italy adds to evidence that the virus may have been spreading far earlier than initially thought and even around Europe in autumn 2019 – months before the first official Italian case in February 2020.
10th Dec 2020 - Metro.co.uk

Covid Pandemic: How South Korea Contained the Coronavirus Without Lockdowns

Park Young Joon was worried that South Korea could lose control. As director for epidemiological investigations at the Korea Disease Control and Prevention Agency, he’d been dispatched to Daegu, a city of 2.5 million in the south, to deal with an urgent situation. A rash of novel coronavirus cases had just emerged among members of the Shincheonji Church of Jesus, an obscure and secretive religious group whose services involve close physical contact. The first congregant tested positive on Feb. 17, becoming South Korea’s 31st Covid-19 patient. Soon the number of new daily cases was in double digits, then triple—evidence that an exponential outbreak was in progress. “I remember seeing the triple-digit cases,” Park says, speaking through a translator, “and thinking to myself that this must be what people mean when they use the word ‘surge.’ 
10th Dec 2020 - Bloomberg

How kids’ immune systems can evade COVID

Young children account for only a small percentage of COVID-19 infections1 — a trend that has puzzled scientists. Now, a growing body of evidence suggests why: kids’ immune systems seem better equipped to eliminate SARS-CoV-2 than are adults’. “Children are very much adapted to respond — and very well equipped to respond — to new viruses,” says Donna Farber, an immunologist at Columbia University in New York City. Even when they are infected with SARS-CoV-2, children are most likely to experience mild or asymptomatic illness2.
10th Dec 2020 - Nature

U.S. FDA advisers overwhelmingly back authorizing Pfizer COVID-19 vaccine

A panel of outside advisers to the U.S. Food and Drug Administration on Thursday voted overwhelmingly to endorse emergency use of Pfizer’s coronavirus vaccine, paving the way for the agency to authorize the shot for a nation that has lost more than 285,000 lives to COVID-19. The FDA is widely expected to authorize emergency use in days. Distribution and inoculations in the United States are expected to begin almost immediately thereafter. The committee voted 17-4 that the known benefits of the vaccine outweighed the risks of taking the shot for individuals 16 and older, with 1 member of the panel abstaining. “This is a historic moment,” Eric Dickson, chief executive of UMass Memorial Health Care, who was not on the advisory panel, said after the vote. He called the vaccine from Pfizer and German partner BioNTech “the best solution to get us out of our current situation and help us save lives.”
10th Dec 2020 - Reuters

'We should have been much tougher' : Sturgeon admits mistakes in Scotland's pandemic response as studies show travel caused second wave

First Minister Nicola Sturgeon has acknowledged mistakes “will have been made” in Scotland’s response to the Covid-19 pandemic, as a new report shows the country was close to eliminating the virus during the first lockdown, but national and international travel re-seeded it.
9th Dec 2020 - The Scotsman

South Korea study shows how coronavirus spreads indoors

The study — adding to a growing body of evidence on airborne transmission of the virus — highlighted how South Korea’s meticulous and often invasive contact tracing regime has enabled researchers to closely track how the virus moves through populations. “In this outbreak, the distances between infector and infected persons were ... farther than the generally accepted 2 meter [6.6-foot] droplet transmission range,” the study’s authors wrote. “The guidelines on quarantine and epidemiological investigation must be updated to reflect these factors for control and prevention of COVID-19.”
9th Dec 2020 - Los Angeles Times


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India says it may approve vaccine in weeks, outlines plan

India’s Health Ministry has announced that some COVID-19 vaccines are likely to receive licenses in the next few weeks and outlined an initial plan to immunize 300 million people. Health officials said Tuesday that three vaccine companies have applied for early approval for emergency use in India: Serum Institute of India, which has been licensed to manufacture the AstraZeneca vaccine, Pfizer Inc., and Indian manufacturer Bharat Biotech. “Some of them may get licensed in the next few weeks,” federal Health Secretary Rajesh Bhushan said.
10th Dec 2020 - The Washington Post

UK medicine regulator says people with anaphylaxis risk should not take Pfizer/BioNTech vaccine

The UK’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy warning about the shot. “Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine. A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine,” said June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA). Earlier it had warned that people with a “significant allergic reaction” to those things should not take the shot, without specifying anaphylaxis.
10th Dec 2020 - Reuters

UK investigates possible allergic reactions to COVID-19 shot

U.K. regulators say people who have a “significant history’’ of allergic reactions shouldn’t receive the new Pfizer/BioNTech vaccine while they investigate two adverse reactions that occurred on the first day of the country’s mass vaccination program
9th Dec 2020 - The Independent

Chinese Covid-19 vaccine has 86% efficacy, UAE says

The United Arab Emirates said a Chinese coronavirus vaccine tested in the federation of sheikhdoms has 86% efficacy, in a statement that provided few details but marked the first public release of information on the performance of the shot. The announcement brought yet another contender into the worldwide race for a vaccine to end the pandemic, a scientific effort in which China and Russia are competing with western firms to develop an effective inoculation.
9th Dec 2020 - The Guardian

'Very inconsistent': Allergic reaction by 2 in UK to COVID-19 vaccine puzzles researchers

Two British people with severe allergies apparently had allergic reactions to Pfizer/BioNTech's COVID-19 vaccine, raising questions about whether it is safe for people with preexisting allergies. In response, British regulators advised those with severe allergies to avoid the vaccine. It was not immediately clear what triggered the allergic reactions. Unlike some vaccines, in the Pfizer/BioNTech vaccine there are no preservatives or egg products, which have been known to trigger reactions with other types of vaccines.
9th Dec 2020 - USA Today

Canada Authorizes Covid-19 Vaccine From Pfizer and BioNTech

Canada became the third country to authorize use of the Covid-19 vaccine produced by Pfizer Inc. and BioNTech SE, racing ahead of the U.S. Food and Drug Administration and Europe’s main regulator to approve shots for its most vulnerable citizens. Canada will now begin its immunization rollout as early as next week—a daunting challenge for a sparsely populated country with the world’s second-largest territory. The country is on schedule to begin inoculations next week, with a portfolio of vaccine candidates that it argues is among the most diverse among large economies.
9th Dec 2020 - The Wall Street Journal

Canada health regulator approves Pfizer’s COVID-19 vaccine.

Canada’s health regulator approved Pfizer’s COVID-19 vaccine Wednesday, days ahead of possible approval in the United States, and said it hopes to start giving the shots next week. The vaccine made by U.S. drugmaker Pfizer and Germany’s BioNTech vaccine already has been authorized for use by the United Kingdom and Bahrain, and officials have said they expect the U.S. authorization within days. “This a momentous occasion,” said Dr. Supriya Sharma, chief medical adviser at Health Canada. “The geek in me is amazed. No one would have thought, even when we looked back at the first discovery of the virus, that less than a year later we would be authorizing and distributing a vaccine.”
9th Dec 2020 - Associated Press

Sinovac: What do we know about China's Covid-19 vaccine?

As the global race to produce a Covid-19 vaccine continues, China appears to have made huge strides, with one of its vaccine front-runners, Sinovac, already making its way abroad. Shipments of Beijing-based biopharmaceutical company Sinovac's Covid-19 vaccine CoronaVac have arrived in Indonesia in preparation for a mass vaccination campaign, with another 1.8m doses due to arrive by January. But the vaccine is yet to finish its late-stage trials, which begs the question: what exactly do we know about this Chinese vaccine?
9th Dec 2020 - BBC

Covid-19 vaccine: Allergy warning over new jab

People with a history of significant allergic reactions should not have the Pfizer/BioNTech Covid jab, regulators say. It came after two NHS workers had allergic reactions on Tuesday. The advice applies to those who have had reactions to medicines, food or vaccines, the Medicines and Healthcare products Regulatory Agency said. The two people had a reaction shortly after having the new jab, had treatment and are both fine now. They are understood to have had an anaphylactoid reaction, which tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure. This is not the same as anaphylaxis which can be fatal. Both NHS workers have a history of serious allergies and carry adrenaline pens around with them.
9th Dec 2020 - BBC

UK healthcare workers seven times more likely to develop severe coronavirus during first lockdown, study finds

Those working on the front lines against coronavirus during the UK’s first lockdown were up to seven times more likely to become severely infected, new research suggests. A University of Glasgow-led study of more than 120,000 employees aged 49 to 64 indicated that those in healthcare roles were seven times more likely to be hospitalised or killed with the virus. And those with jobs in the social care and transport sectors were found to be twice as likely to suffer such outcomes, which the researchers said emphasises the need to ensure that key workers are adequately protected against infection.
9th Dec 2020 - The Independent

Significant increase in depression seen among children during first UK lockdown

The first lockdown led to a significant increase in symptoms of depression among children, highlighting the unintended consequences of school closures, according to a new study from the University of Cambridge. In response to the COVID-19 pandemic, the UK Government implemented a national "lockdown" involving school closures and social distancing. There has been widespread concern that these measures would negatively impact child and adolescent mental health. To date, however, there is relatively little direct evidence of this. The most direct way of measuring the association between the onset of lockdown and children's mental health is to follow the same individuals over a length of time and look for changes - so-called 'longitudinal' changes.
9th Dec 2020 - EurekAlert!

China's government-made coronavirus vaccine 'is 86% effective' and has been approved for use by the UAE after clinical trials - but scientists behind it have yet to publicly ...

Vaccine from state-owned company Sinophar is one of four made by China UAE officials today claim the phase three trials show it is 86% effective No data on the vaccine has yet been publicly released despite its approval Vaccine is a weakened form of virus and UAE has been running trials since July Dubai ruler Sheikh Mohammed bin Rashid Al-Maktoum received an unnamed jab and reports claim so too has North Korea leader Kim Jong Un
9th Dec 2020 - Daily Mail

To defeat Covid-19, we must acknowledge the fear it engenders

My career as a hospital epidemiologist has been based on science and evidence, which I believed to be the touchstones of my work. But Covid-19 has taught me that fear — gut-wrenching, all-consuming fear, like the fear of dying from a horrific respiratory virus — can be much more powerful than science. We can’t conquer this fear unless we acknowledge and respect it. I’m no stranger to my work keeping me awake at night. In pre-pandemic times, I sometimes lost sleep over issues like a spike in staph infections in a particular intensive care unit
9th Dec 2020 - STAT News

Pharma Pfizer’s COVID vaccine data raise some flags, analysts say, but not enough to scuttle an FDA nod

When the FDA released a 53-page briefing document on Pfizer’s COVID-19 mRNA vaccine candidate yesterday, most readers zeroed in on the shot’s high efficacy in a wide range of demographic groups. Wall Street analysts dug a bit deeper. Their conclusion? A few red flags in the FDA documents will likely generate some discussion at Thursday's advisory panel meeting, but not enough alarm to scuttle an emergency authorization.
9th Dec 2020 - FiercePharma

UK warns people with serious allergies to avoid Pfizer vaccine after two adverse reactions

Britain’s medicine regulator warned people with significant allergies not to get Pfizer-BioNTech’s COVID-19 vaccine after two people suffered adverse reactions, but was set to give more detailed guidance on Wednesday based on reviews of those cases.
9th Dec 2020 - Reuters

EU agency in charge of COVID-19 vaccine approval says it was hacked

The European Medicines Agency (EMA), the EU regulatory body in charge of approving COVID-19 vaccines, said today it was the victim of a cyber-attack. In a short two-paragraph statement posted on its website today, the agency discloses the security breach but said it couldn't disclose any details about the intrusion due to an ongoing investigation. EMA is currently in the process of reviewing applications for two COVID-19 vaccines, one from US pharma giant Moderna, and a second developed in a collaboration between BioNTech and Pfizer.
9th Dec 2020 - ZDNet

Warning after two NHS workers have allergic reaction to Pfizer/BioNTech Covid vaccine

People with a history of “significant” allergic reactions have been told not to take the Pfizer/BioNTech Covid-19 vaccine after two NHS workers who received the jab had “adverse" reactions. NHS England confirmed that two staff members who were administered doses on Tuesday – on the first day of the mass vaccination programme – suffered an allergic reaction. Both staff members have a significant history of allergic reactions, to the extent where they need to carry an adrenaline auto-injector with them, it is understood.
9th Dec 2020 - Evening Standard

Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say

U.S. drugmaker Pfizer and its German partner BioNTech said on Wednesday that documents related to development of their COVID-19 vaccine had been "unlawfully accessed" in a cyberattack on Europe's medicines regulator. The European Medicines Agency (EMA), which assesses medicines and vaccines for the European Union, said hours earlier it had been targeted in a cyberattack. It gave no further details. Pfizer and BioNTech said they did not believe any personal data of trial participants had been compromised and EMA "has assured us that the cyber attack will have no impact on the timeline for its review."
9th Dec 2020 - Reuters

Pfizer's first shipment of its coronavirus vaccine will include 2.9 million doses upon FDA approval

Pfizer Inc's first shipment of its vaccine to the US will include 2.9 million doses and another shipment 21 days later with the same amount. The jabs will be going to 636 locations, mostly large health-care systems with enough storage capacity. Gen Gustave Perna said he has set aside a reserve of 500,000 doses from the total supply of 6.4 million available to the US. At an Operation Warp Speed briefing on Wednesday, HHS Secretary Alex Azar said he'd be willing to get vaccinated publicly The team said they have not considered who would receive the very first vaccine or where. The FDA will meet Thursday and Friday - and are expected to approve the vaccine by the end of the week
9th Dec 2020 - Daily Mail

Don't mix Sputnik vaccine with alcohol, says Russian official. Some recoil

A health official’s warning that anyone getting vaccinated against COVID-19 with Russia’s Sputnik V vaccine should give up alcohol for almost two months has caused a backlash among some Russians who call the request unreasonable. Anna Popova, head of the consumer health watchdog, told the Komsomolskaya Pravda radio station on Tuesday that people should stop drinking alcohol at least two weeks before getting the first of two injections. They should continue to abstain for a further 42 days, she advised.
9th Dec 2020 - Reuters


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AstraZeneca Covid-19 Vaccine Trial Data Underscore Safety, Range of Efficacy

Peer-reviewed data from late-stage human trials of a Covid-19 vaccine developed by the University of Oxford and AstraZeneca PLC reaffirmed the shot’s strong safety results and provided some additional evidence that halving the first of two doses of the shot boosts its effectiveness. AstraZeneca and Oxford said the data gave them confidence to ask the U.K. and other countries for emergency-use authorization of the vaccine, but said regulators will have to decide which dosing regimen to approve. Last month, AstraZeneca and Oxford said trial data showed the vaccine was between 62% and 90% effective, but that the higher results were observed in a small subset of the wider trial.
8th Dec 2020 - The Wall Street Journal

Inovio sets new timeline for its experimental Covid-19 vaccine

Plymouth Meeting's Inovio Pharmaceuticals provides an updated timeline for its experimental Covid-19 vaccine and says it expects to play an important role in the battle against the coronavirus. On Monday, Inovio began phase-II testing of its DNA-based Covid-19 vaccine candidate, INO-4800.
8th Dec 2020 - The Business Journals

Studies suggest AstraZeneca COVID-19 vaccine safe, effective

New results on a possible COVID-19 vaccine from Oxford University and AstraZeneca suggest it is safe and about 70% effective, but questions remain about how well it may help protect those over 55 — a key concern for a vaccine that health officials hope to rely on around the world because of its low cost, availability and ease of use. Still, experts say the vaccine seems likely to be approved, despite some confusion in the results and lower levels of protection than what some other vaccine candidates have shown.
8th Dec 2020 - ABC News

Oxford-Astra COVID-19 vaccine shows average 70.4% efficacy in pooled study

AstraZeneca and Oxford University have more work to do to confirm whether their COVID-19 vaccine can be 90% effective, peer-reviewed data published in The Lancet showed on Tuesday, potentially slowing its eventual rollout in the fight against the pandemic. Once seen as the frontrunner in the development of a vaccine against the coronavirus crisis, the British team was overtaken by U.S. drugmaker Pfizer, whose shots - with a success rate of around 95% - were administered to UK pensioners on Tuesday in a world-first hailed as V-Day. Detailed results from the AstraZeneca/Oxford trials have been eagerly awaited after some scientists criticised a lack of information in their initial announcement last month.
8th Dec 2020 - Reuters

FDA Review Of Pfizer Vaccine Data Confirms Protection Against Covid-19 Infection

“There are so many amazing facts in here,” Akiko Iwasaki, an immunology professor at Yale said in a tweet about her review of the materials. Including, she continued, that “[p]eople who received the Pfizer vaccine are protected from Covid-19 as early as 12 to 13 days post first dose.” These materials will be used by the FDA this Thursday at a meeting of the regulatory body’s Vaccines and Related Biological Products Advisory Committee, which will use them to determine whether to grant an EUA. That decision could come as early as Thursday and, if granted, would mean that administration of the vaccine could begin in the United States. The two companies have already received similar authorization from the United Kingdom, where the first doses of the vaccine to the general population were administered Tuesday.
8th Dec 2020 - Forbes

AstraZeneca reaffirms COVID-19 vaccine data after experts question results from manufacturing error; shown to be 70% effective

Data on a candidate COVID-19 vaccine made by AstraZeneca and Oxford University are strong enough to present to regulators in the U.K., Europe and elsewhere around the world, the collaborators said Tuesday, but they don’t expect approval from the U.S. without more data from American volunteers. The team presented their data Tuesday in the medical journal, The Lancet, the first late-stage trial information to be published under peer review, with careful independent analysis.
8th Dec 2020 - USA Today

Oxford Covid-19 vaccine has good safety record and efficacy – study

Interim results from pooled studies show the vaccine was 70.4% effective, on average, in preventing coronavirus after two doses were given. For people given two full doses of the jab in one study, the vaccine was 62.1% effective. In a study where people received a half dose followed by a full dose, the vaccine was 90% effective. The overall efficacy of 70.4% is based on 11,636 volunteers across the United Kingdom and Brazil, and combined across three groups of people vaccinated. But on a day when the NHS started rolling out the Pfizer/BioNTech vaccine in older people, health staff and care home workers, the Oxford researchers said more detail is required on how effective their vaccine is in older adults.
8th Dec 2020 - Aberdeen Evening Express

Biden's Covid-19 Task Force Needs Behavioral Scientists

By now it’s clear that bringing the pandemic under control will require a range of actions that can persuade people opposed to wearing masks, socially distancing, or getting vaccinated to change their behaviors. For this reason, President-elect Joseph Biden should add to his Covid-19 task force social and behavioral scientists who have the expertise to design and apply such interventions.
8th Dec 2020 - Harvard Business Review

Could Slovakia's mass testing programme work in England?

The UK’s response to the covid-19 pandemic has, on any measure, been unimpressive. In a recent assessment of G7 countries, it came out second worst in the cumulative number of deaths in relation to population, just behind Italy. It was worst in terms of the contraction of the economy. These facts were well known. What was new, and surprising, was that it had achieved these unenviable positions despite spending far more than most of the other countries. Using a measure based on the core budget deficit, it spent 80% more than the average among these industrialized countries, beaten only by Canada. Faced with this predicament, it is understandable that ministers would look elsewhere for ideas. At first it was Sweden, with Downing Street seeking advice from its chief epidemiologist, Anders Tegnell. Sweden’s refusal to adopt the stringent measures imposed elsewhere had obvious attractions for a party committed to individual freedom, with ministers who had spent many years criticizing the “nanny state.” Unfortunately, as the evidence from Stockholm accumulated, revealing a magnitude of economic decline similar to that in its locked down neighbours, but at a much higher cost in lives, the attraction waned, finally evaporating when the second wave, which advocates for the Swedish model predicted would not happen, became apparent.
8th Dec 2020 - The BMJ

Lockdowns work, says former AHS head who helped bring Australia's COVID cases under control

The first president of Alberta Health Services says Australia's strict lockdown shows it's possible to reach zero COVID-19 cases. He would know, as one of the authors of the report that guided the country's restrictions. "We eliminated the virus. The feeling of relief and celebration, how proud we were that we'd done it, after 110 days of lockdown, was immense … and we're going back to normal. Since last night, I can have 30 people, I think, in my house, if I want to," Stephen Duckett said, speaking to CBC News from Melbourne. "The evidence is that there's no conflict between what's right for the economy, what's right for people's health … people in hospital don't spend money." The health economist was hired as AHS's first president and CEO in 2009 — but shortly after his appointment, the province cut the newly created agency's budget by $1 billion. He left in 2010.
8th Dec 2020 - CBC.ca

Sinovac vaccine shows up to 97 per cent efficacy in early trials, Bio Farma says

Indonesia's state-owned pharmaceutical company Bio Farma said on Tuesday that interim data on trials it was conducting on vaccines produced by the Chinese company Sinovac showed up to 97 per cent efficacy. "Our clinical trial team found, within one month, that the interim data shows up to 97 per cent for its efficacy," said Iwan Setiawan, a spokesman for Bio Farma, at a news conference.
8th Dec 2020 - The Sydney Morning Herald

FDA staffers sing Pfizer/BioNTech COVID shot's praises ahead of key committee meeting

The FDA has released its internal review documents ahead of the closely watched COVID-19 vaccine advisory committee meeting scheduled for Thursday—and they bode well for Pfizer and partner BioNTech's prospects for securing a quick emergency use authorization (EUA). The FDA meeting briefing, published (PDF) on Tuesday, confirmed the efficacy and safety profile of Pfizer and BioNTech’s BNT162b2, reiterating that the shot was 95% effective at preventing COVID-19 after two doses with no serious safety concerns.
8th Dec 2020 - FiercePharma

Not enough Pfizer vaccine doses? Blame the feds, not the company: reports

Just as thousands of Brits were lining up to get Pfizer’s mRNA COVID-19 vaccine yesterday, a troubling question emerged in the U.S.: Did the United States government fail to lock in enough doses of the vaccine to ensure a broad and quick rollout here? The short answer appears to be yes. And reviewers were full of praise for the vaccine’s clinical program. BNT162b2’s development has “ensured the highest compliance and quality standards while progressing expeditiously” to address the pandemic, the agency wrote in its executive summary. Statistical analysis suggests the vaccine’s true efficacy is at least 90.3% with a possibility of hitting as high as 97.5%. Notably, the efficacy was consistently high at 94.7% for participants at 65 years of age or older. And even in those with underlying conditions who are considered at risk of developing serious COVID cases, the vaccine’s efficacy stood strong at 95.3%.
8th Dec 2020 - FiercePharma

Sinovac snags $515M investment to double COVID-19 vaccine capacity as phase 3 readout nears

As the various COVID-19 vaccines move closer to the finish line, their developers have been raising money from investors or through advance government purchases to ramp up manufacturing. Now, a Chinese company has done the same for its candidate. Sinovac Biotech netted $515 million in investment from local firm Sino Biopharmaceutical, which in exchange gets a 15.03% stake in Sinovac Life Sciences, a subsidiary of the Nasdaq-listed vaccine specialist. The money will help fund development, manufacturing and new production capacity for Sinovac’s COVID-19 vaccine candidate, CoronaVac, as well as other activities, Sinovac said Monday. Currently, Sinovac can make 300 million doses of CoronaVac a year. But the company hopes to finish building another production facility by the end of 2020 to boost annual capacity to 600 million doses, with the potential to expand output even further in the future. CoronaVac, an inactivated shot, is one of the front-running COVID-19 vaccines. It's actually been used in China in a secretive emergency use program. Meanwhile, it's undergoing phase 3 trials in Brazil, Chile, Turkey and Indonesia, with supply deals in place with these countries.
8th Dec 2020 - FiercePharma

Phase 3 trials show AstraZeneca COVID vaccine has up to 90% efficacy

The first full peer-reviewed results of phase 3 trials of the COVID-19 vaccine developed by AstraZeneca and Oxford University show that it is safe and up to 90% effective in preventing infection, supporting regulatory submissions for emergency use. The interim analysis, published today in The Lancet, identified no severe coronavirus disease or hospitalizations in pooled results from the 11,636 adults vaccinated in the United Kingdom and Brazil. Of the 11,636 adults, 131 (1.1%) had symptomatic COVID-19 more than 14 days after the second vaccine dose, including 30 of 5,807 (0.5%) in the COVID-19 vaccine group and 101 of 5,829 (1.7%) in the control group, indicating a vaccine efficacy of 70%
8th Dec 2020 - CIDRAP

FDA documents show Pfizer COVID vaccine protects after 1 dose

Food and Drug Administration (FDA) documents posted in advance of advisory group consideration of emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine revealed promising new findings, including strong protection after the first dose and protection in groups at risk for disease complications. The good news comes on the same day immunization with the vaccine began with much fanfare in the United Kingdom, where a 90-year-old woman who lives in Coventry was the first to receive it outside of a vaccine trial.
8th Dec 2020 - CIDRAP

FDA scientists endorse ‘highly effective’ Pfizer/BioNTech Covid-19 vaccine ahead of key panel

Scientists at the Food and Drug Administration endorsed the efficacy and safety of the Covid-19 vaccine from Pfizer and BioNTech in detailed documents released Tuesday, setting the stage for an emergency authorization as early as this week. The documents are a prelude to a Thursday meeting of outside experts, which is likely the final step before the FDA grants an emergency use authorization, or EUA. The FDA reviewers state that the two-dose vaccine was “highly effective” in preventing symptomatic Covid-19, and that the data “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.” The data also suggest that the two-dose vaccine may begin preventing some Covid-19 cases after the first dose.
8th Dec 2020 - STAT News

Detailed data on AstraZeneca-Oxford Covid-19 vaccine show it has moderate efficacy

The Covid-19 vaccine being developed by the University of Oxford and AstraZeneca appears to have moderate efficacy in preventing symptomatic illness, and may significantly reduce hospitalization from the disease, data from four clinical trials of the vaccine reveal. The highly anticipated publication of the data, released Tuesday in The Lancet, also point to some signals that deserve further exploration — the possibility of protection after a single dose and the suggestion that at least one dosing regimen may have led to a decrease the number of asymptomatic infections.
8th Dec 2020 - STAT News

Densely packed BAME communities in England bear brunt of Covid-19

Some of England’s most ethnically diverse areas have suffered up to four times more coronavirus infections than mostly white neighbourhoods only a few miles away, a Guardian analysis reveals, as health experts said the UK had paid the price for failing to tackle structural racism. A study of England’s 10 worst-hit council areas found huge disparities in the effect of Covid-19 on residents living alongside one another, with densely packed Black, Asian and minority ethnic (BAME) communities bearing the brunt of the pandemic. In Blackburn with Darwen, which has experienced the UK’s highest coronavirus cases per capita, the contrast between neighbouring areas is stark. One in 10 people have had the virus in Bastwell, where 85.7% of residents come from a BAME background – four times higher than a neighbourhood five miles away where only 2% of people are non-white.
7th Dec 2020 - The Guardian

Turkey’s domestic COVID-19 vaccine set for next stage of human trials

Officials say the Phase 1 human trials of ERUCOV-VAC developed at Erciyes University in central Turkey will conclude on Dec. 14. and that Phase 2 may begin two days later. If the vaccine is proven to be effective, it will be added to Turkey's growing arsenal of vaccines to put an end to the coronavirus outbreak in the country. Turkey announced it had received a shipment of the Chinese vaccine earlier. Ahmet Inal, deputy director of the university's research center where trials are being conducted, says they had 44 volunteers for the first phase, and they were planning to inoculate some 200 volunteers in the second phase. He noted that they have already received more than 100 volunteer applications.
6th Dec 2020 - Daily Sabah


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 8th Dec 2020

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COVID-19: Scientific breakthrough in monitoring infections through wastewater

Scientists have achieved a breakthrough in sampling wastewater to detect changes in COVID-19 infections within large communities. The new method is capable of identifying the coronavirus within wastewater samples and tracking whether infection rates are growing or shrinking. Wastewater is a "robust source" of COVID-19, according to researchers, because infected people shed the virus in their stool, meaning large amounts of virus particles are flushed down the toilet.
8th Dec 2020 - Sky News

Chinese drugmaker gets $500m boost to push Covid-19 vaccine

Chinese pharmaceutical company Sinovac has secured a $515m cash injection, as one of the country’s leading vaccine hopefuls looks to increase production and distribution of its Covid-19 vaccine once final-stage testing is concluded. Sino Biopharmaceutical, a Hong Kong-listed generic drugs group, said on Monday it had acquired a 15 per cent stake in Sinovac Life Sciences, the subsidiary of Sinovac that has developed a Covid-19 vaccine undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile. Sinovac’s vaccine — alongside two other candidates developed by state-run group Sinopharm — is a Chinese frontrunner to be sold worldwide.
7th Dec 2020 - The Financial Times

Years of research laid groundwork for speedy COVID-19 shots

How could scientists race out COVID-19 vaccines so fast without cutting corners? A head start helped -- over a decade of behind-the-scenes research that had new vaccine technology poised for a challenge just as the coronavirus erupted. “The speed is a reflection of years of work that went before,” Dr. Anthony Fauci the top U.S. infectious disease expert, told The Associated Press. “That’s what the public has to understand.” Creating vaccines and having results from rigorous studies less than a year after the world discovered a never-before-seen disease is incredible, cutting years off normal development. But the two U.S. frontrunners are made in a way that promises speedier development may become the norm -- especially if they prove to work long-term as well as early testing suggests.
7th Dec 2020 - The Independent

Dr Fauci warns that coronavirus shots will take WEEKS to lower COVID-19 death rates as US Surgeon General begs Americans to 'hold on a little longer because vaccines are coming'

FDA regulators will meet to decide if Pfizer's coronavirus vaccine is ready to be used in the general public on December 10. If it gets emergency approval, it could be rolled out as early as this week. But the shot is given in two doses, injected 21 days apart, and doesn't become protective until about 7-10 days after the second dose. Dr Anthony Fauci warned there will be a delay between the first rollout of the vaccines and a decline in deaths, said he can 'guarantee' it will come
7th Dec 2020 - Daily Mail

Prototype blood test detects people who will develop severe Covid-19

Test detects whether our immune systems are gearing up to fight SARS-CoV-2 It assesses levels of two molecules in the blood linked with our immune response People with low levels of these molecules could be at risk of more severe Covid Scientists say the test could be important during the wait for vaccines to roll out
7th Dec 2020 - Daily Mail

We still need Covid-19 treatments as well as vaccines

It’s a Friday morning in October and Charlotte Summers has been up since the crack of dawn. As a leading expert in respiratory and intensive care medicines, she is one of the clinical researchers responsible for advising on the UK’s national treatment guidelines for Covid-19. But overnight, results of a trial by the World Health Organisation have been published concluding that remdesivir – an antiviral drug global leaders once pinned high hopes on – has “little or no effect” on patient survival.
7th Dec 2020 - Wired.co.uk

WHO looks at giving Covid-19 to healthy people to speed up vaccine trials

The World Health Organization is holding discussions on Monday about the feasibility of trials in which healthy young volunteers are deliberately infected with coronavirus to hasten vaccine development – amid questions over whether they should go ahead given the promising data from the frontrunner vaccine candidates. Some scientists have reservations about exposing volunteers to a virus for which there is no cure, although there are treatments that can help patients. However, proponents argue that the risks of Covid-19 to the young and healthy are minimal, and the benefits to society are high.
7th Dec 2020 - The Guardian

UK could suffer a 'severe' third wave of Covid in January if we 'take our foot off the pedal', SAGE scientist warns

Professor Andrew Hayward warned that the pandemic is still not over today He said it would be 'sad' for cases to surge following the Christmas period Covid-19 vaccine is a ray of hope for ending pandemic in the next few months
7th Dec 2020 - Daily Mail

1.2M doses of China-made COVID vaccine arrive in Indonesia

Indonesia’s government said 1.2 million doses of a COVID-19 vaccine developed by China-based biopharmaceutical company Sinovac Biotech arrived in the country late Sunday. President Joko Widodo said in a televised address that another 1.8 million doses of the vaccine are expected to arrive in early January. “We are very grateful, thank God, the vaccine is now available so that we can immediately curb the spread of the COVID-19 disease,” Widodo said. The government is still waiting for millions of other doses of the Sinovac vaccine to arrive in the form of raw materials that will be further processed by state-owned pharmaceutical holding company PT Bio Farma.
7th Dec 2020 - Associated Press

The 12.39am email that triggered Australia's response to COVID-19

Epidemiologist Professor Jodie McVernon was in the Qantas lounge at Canberra airport on the evening of February 3, when she took an urgent call from Brendan Murphy, then the Commonwealth’s chief medical officer. McVernon had for days been "obsessively" tracking information on the mysterious new virus seeping out of Wuhan, China. Murphy had a fresh task for her. "Your Prime Minister needs a projection, a future scenario, in 48 hours," he told her. McVernon’s colleague, mathematical biologist Professor James McCaw, was also on the road when he received the same news. The two long-time collaborators had little more than two days to get a brief to the federal government’s National Security Committee – a first stab at how the alarming new threat might evolve. It was a curtain-raiser to what would prove to be the most destructive pandemic to sweep the world since the Spanish flu 100 years before.
7th Dec 2020 - The Sydney Morning Herald

Covid-19: 300 fewer people died during lockdown, despite less access to healthcare - Ministry of Health

Three hundred fewer people died during the Covid-19 lockdown compared to recent years, even as thousands of patient appointments were cancelled and GPs closed their doors to all but the most urgent cases. The Ministry of Health has published a report examining the impact of Covid-19 on hospital and general practice activity, which was reduced to all but the most essential services during lockdown to contain the virus, and how any changes effected patient health. As expected it showed a drastic reduction in people in hospital, with 40,000 fewer people discharged from hospital in April alone, the peak of the lockdown. Planned care in hospitals halved in April and the data shows this reduction, as well as a reduction in emergency care, disproportionately effected Māori and Pasific people.
7th Dec 2020 - Stuff.co.nz

A whistleblower says the FDA isn’t properly regulating vaccine facilities

While much attention has been given to approving a COVID-19 vaccine, there's been little paid to the facilities where many vaccines are manufactured. A recent investigation in Vanity Fair features a former FDA inspector turned whistleblower who says that the FDA is not doing its job. Vanity Fair Contributing Editor Katherine Eban, the author of the piece, joins Hari Sreenivasan to discuss.
7th Dec 2020 - PBS.org

A new report adds to the evidence of a coronavirus coverup in China

The truth about the origin of the coronavirus in China a year ago remains shrouded in mystery. It is not known where the virus came from, nor how it infected humans. But after people started getting sick, it is evident that the scope of the outbreak was hidden from the Chinese people and from the rest of the world. A report by Nick Paton Walsh of CNN on Dec. 1 adds to evidence of a coverup, an authoritarian system in action. CNN obtained 117 pages of internal records from the Hubei Provincial Center for Disease Control and Prevention containing tallies of cases and deaths far greater than those provided to the public and the world by the Chinese government. Wuhan is the capital and largest city of Hubei province.
6th Dec 2020 - The Washington Post

Diabetes drug linked to lower COVID-19 death rate in women

A Lancet Healthy Longevity study yesterday found that metformin—a common, generic type 2 diabetes medication used to manage blood sugar levels—is associated with significantly lower COVID-19 death risk in women, but not in men. Severe COVID-19 outcomes for people with diabetes have been widely observed, including greater risk of intensive care unit admission, intubation for mechanical ventilation, and death, possibly related to less effective glycemic, or blood sugar, control in these patients. This retrospective cohort study of 6,256 people with type 2 diabetes or obesity hospitalized for COVID-19 from Jan 1 to Jun 7 was a collaboration between the University of Minnesota Medical School and UnitedHealth Group (UHG)—a for-profit managed healthcare company based in Minnesota.
4th Dec 2020 - CIDRAP

WHO hails COVID vaccine progress, urges nations to double down on mitigation

At a media briefing today, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said decisions by country leaders in the coming days will set the course for the virus in the short term and influence when the pandemic will eventually end. He said though vaccine progress brings hope, the WHO is worried about a growing perception that the pandemic is over. "The truth is that at present, many places are witnessing very high transmission of the virus, which is putting enormous pressure on hospitals, intensive care units and health workers," he said.
4th Dec 2020 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 7th Dec 2020

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Research into Covid-19 dog detectors begins

Dogs could be used in the fight against Covid-19 – by being trained to sniff out infected people. Researchers in Australia have begun to train 14 dogs in a feasibility study, and the animals could become part of the screening process for incoming visitors if successful. Studies have previously shown dogs can detect particular odours – known as volatile organic compounds (VOCs) – which are produced by humans when they are suffering with a viral infection. Dr Anne-Lise Chaber of the University of Adelaide’s School of Animal and Veterinary Sciences said the current training – in Adelaide and at the Australian Border Force’s National Detector Dog Programme Facility – will test the accuracy of dogs detecting VOCs in sweat samples from people infected with coronavirus.
6th Dec 2020 - MSN.com

The vaccine miracle: how scientists waged the battle against Covid-19

In the early afternoon of 3 January this year, a small metal box was delivered to the Shanghai Public Health Clinical Centre addressed to virus expert Prof Zhang Yongzhen. Inside, packed in dry ice, were swabs from a patient who was suffering from a novel, occasionally fatal respiratory illness that was sweeping the city of Wuhan. Exactly what was causing terrifying rises in case numbers, medical authorities wanted to know? And how was the disease being spread? Zhang and his colleagues set to work. For the next 48 hours, virtually non-stop, he and his team used advanced sequencing machines to unravel the RNA – the genetic building blocks – of the virus which they believed was responsible for the outbreak. Decoding the 28,000 letters of this RNA – which acts as letters of DNA do in a human – would give a precise indication of the new pathogen’s nature and behaviour.
6th Dec 2020 - The Guardian

Covid test-and-trace: Is backwards contact tracing the way forward?

Contact tracing is about detective work - and there are different ways to do it. If a person tests positive, forward contact tracing means finding all the people they could have passed the virus on to, and asking them to self-isolate. For backwards contact tracing, the aim is to find who gave the virus to the person who tested positive. The theory is that if they have already passed on the virus, they're more likely to have infected other people as well, because of how superspreading works. Then their contacts are found, and asked to self-isolate, too. If the effort is just on going forward, then "potentially a lot of cases won't have infected people", said Dr Adam Kucharski, of the London School of Hygiene and Tropical Medicine. The result is a big part of the outbreak will be missed, he says. But because cases are often linked to superspreading events, going backwards could pick up infections that might otherwise be missed
6th Dec 2020 - BBC

New Zealand Covid minister urges patience in wait for vaccine approval

New Zealand’s Covid-19 minister has called for patience in the country’s vaccine roll-out programme, saying he was unlikely to follow the UK in using emergency provisions to fast-track approval. Covid-19 minister Chris Hipkins said: “We are in a slightly different position to other countries who are using emergency provisions to approve the vaccine, and in many cases those countries are doing that because they are suffering hugely from Covid, with thousands of people dying every day.”
6th Dec 2020 - The Guardian on MSN.com

COVID-19 reinfections likely as antibody counts fall: WHO

The World Health Organization (WHO) confirmed that new data suggest individuals who were once infected with COVID-19 can be susceptible to secondary infections as antibodies die off. “We have seen the number of people infected continue to grow, but we’re also seeing data emerge that protection may not be lifelong, and therefore we may see reinfections begin to occur,” Mike Ryan, executive director of the WHO’s health emergencies program, said per CNBC. “So the question is: What are the levels of protection in society?” Researchers at the WHO are now working to determine how long antibodies in response to COVID-19 last in the human system.
6th Dec 2020 - The Hill

Coronavirus | Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country. Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain. The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources said.
6th Dec 2020 - The Hindu

Indonesia receives first COVID-19 vaccine from China's Sinovac

Indonesia received its first shipment of coronavirus vaccine from China on Sunday (Dec 6), President Joko Widodo said, as the government prepares a mass inoculation programme. Jokowi, as the president is widely known, said in an online briefing that the country received 1.2 million doses from China's Sinovac Biotech, a vaccine Indonesia has been testing since August. He added that the government plans to receive another 1.8 million doses in early January. Late-stage trials of the Sinovac vaccine are also under way in Brazil and Turkey, with interim results on efficiency from Brazil expected by mid-December. Indonesia is also expected this month to receive shipments of raw materials to produce 15 million doses and materials for 30 million doses next month, the president said.
6th Dec 2020 - CNA

Bahrain becomes second country to approve Pfizer COVID-19 vaccine

Bahrain said it had approved the emergency use of a COVID-19 vaccine developed by Pfizer and German partner BioNTech. The approval on Friday makes Bahrain the second country in the world to grant an emergency use authorisation for the vaccine, the Bahraini national news agency BNA reported.
5th Dec 2020 - AlJazeera

Wuhan lockdown diarist Fang Fang on writing to preserve the truth

Chinese novelist Fang Fang was in a funk when she decided to become the unofficial chronicler of life under coronavirus-induced lockdown in Wuhan, the city in central China where the virus was first discovered in December 2019. At 10am on January 23, the government largely cut off the city’s 11 million inhabitants from the rest of the world. Fang Fang, the pen name of Wang Fang, one of China’s most celebrated writers, has lived in Wuhan since early childhood. The travel restrictions looked at the time like a drastic step. Across China, a population haunted by the Sars epidemic of 2003 cancelled Lunar New Year plans and began to obsess over this new public health crisis.
5th Dec 2020 - Financial Times

'76 Days' review: Inside Wuhan hospitals during COVID-19

The first minutes of the experiential COVID-19 documentary “76 Days” are claustrophobic and disorienting — a feeling not unlike your first trip to the grocery store while wearing a mask. But it gets better. In the controlled chaos of a hospital’s corridors, everyone is sheathed head to toe in PPE. We see a woman screaming to say goodbye to her father and having to be restrained. A crowd bangs on a door pleading to be let in as the hospital staff reassures them that they will all be admitted if they only remain patient.
5th Dec 2020 - Los Angeles Times

CDC urges 'universal mask use' indoors for the first time in U.S.

The CDC suggested the universal use of face masks in a new report on Friday. The agency said proper face masks should be worn anywhere outside of an individuals' home. Report said the US has reached a 'phase of high-level transmission' amid the winter weather, holiday seasons and flu season. President-elect Joe Biden announced he will ask Americans to wear face masks for up to 100 days when inaugurated. Covid-19 deaths and hospitalizations have increased across the country. CDC said national forecasts predicted between 9,500 and 19,500 new Covid-19 deaths will be counted during the week ending December 26
5th Dec 2020 - Daily Mail

WHO pulled report on Italy’s ‘chaotic’ first response to Covid-19

Italy’s response to the Covid-19 pandemic was “improvised” and “chaotic” according to a World Health Organisation report that was taken down from the body’s website just hours after publication in May. The assessment titled “An unprecedented challenge, Italy’s first response to Covid-19” was completed by a group of pan-European WHO scientists led by Venice-based Francesco Zambon. It was published on the WHO’s website on May 13, including an introduction written by Europe’s WHO director, Hans Kluge, but was removed the next day. The WHO issued no public statement at the time to indicate that it had withdrawn the report or explain why. According to the 102-page document, seen by the Financial Times, Italy’s decentralised approach to public health policy, as well as delays in testing and tracing potential Covid-19 infections, contributed to worsening the outcome of the first phase of the pandemic.
5th Dec 2020 - The Financial Times

Deadly COVID-19 outbreaks in two long-term care facilities could be linked to Washington state wedding, officials say | TheHill

A Washington state wedding last month that hosted more than 300 people may now be linked to deadly coronavirus outbreaks at two long-term care facilities, officials said Friday. The Nov. 7 wedding at a private location near Ritzville, Wash., first gained attention when nearly 40 attendees from the neighboring Grant County had tested positive for COVID-19 within 10 days of the event. Washington state health guidelines at the time limited wedding ceremonies to 30 people. The Grant County Health District is now saying that staff at two long-term care facilities who attended the wedding, which has been labeled by officials as a “super-spreader” event, contracted the virus. According to ABC News, health officials said that the staff members worked while they were contagious, before they were aware that they were carrying the infection.
5th Dec 2020 - The Hill

Britain gets ready for roll-out of Pfizer's COVID-19 vaccine this week

Britain is preparing to become the first country to roll out the Pfizer/BioNTech COVID-19 vaccine this week, initially making the shot available at hospitals before distributing stocks to doctors’ clinics, the government said on Sunday. The first doses are set to be administered on Tuesday, with the National Health Service (NHS) giving top priority to vaccinating the over-80s, frontline healthcare workers and care home staff and residents. Britain gave emergency use approval for the vaccine developed by Pfizer and BioNTech last week - jumping ahead in the global race to begin the most crucial mass inoculation programme in history. In total, Britain has ordered 40 million doses - enough to vaccinate 20 million people in the country of 67 million.
5th Dec 2020 - Reuters

To roll out Covid-19 vaccines, vaccinate everyone in several hot zones

Dear CEOs of Pfizer, Moderna, and AstraZeneca, Thank you for rapidly mobilizing your scientific resources and your vaccine clinical trial networks. (We also thank Operation Warp Speed and others for organizing and underwriting your efforts to tame Covid-19.) Your vaccines are on the brink of crossing the finish line of approval, but the confusion surrounding the presidential transition has brought great uncertainty to the distribution plan.
5th Dec 2020 - STAT

Covid-19: Care home vaccinations to start 'within two weeks'

The coronavirus vaccine will "definitely" be ready to go into care homes in the next two weeks, the medicines regulator has said. The Medicines and Healthcare products Regulatory Agency (MHRA) said it has approved the way doses will be distributed to homes. But it means care home residents and staff may not be the first to receive jabs, despite being the top priority. Vaccinations are expected to begin at 50 hospital hubs in England on Tuesday. NHS England also says GP-run vaccination centres will be up and running from 14 December and are expected to start inviting in patients aged over 80. Because of how the vaccine doses are packed, the regulator needs to approve the way in which they are broken down into smaller consignments for distribution to care homes, while ensuring that the vaccine stays at very cold temperatures.
4th Dec 2020 - BBC

COVID-19 immunity 'could last three months after infection or vaccination'

People who receive a COVID-19 vaccination may have immunity for 90 days, the government’s scientific advisers have said. In a paper considered by the Scientific Advisory Group for Emergencies (SAGE), which also looked into the much-discussed concept of immunity certificates, the experts say that the length of immunity from "natural infection or vaccination is currently not known". However, they say that "waning immunity" is believed to partly cause other coronaviruses to reinfect after one to two years.
4th Dec 2020 - Sky News

Blood Tests Of Immune Response May Be Key To Future COVID-19 Vaccine Development : Shots - Health News

News today from Harvard's Center for Virology and Vaccine Research may help solve a problem that future COVID-19 manufacturers are sure to face: how to make sure that new and potentially better vaccines actually work without doing extremely large and expensive studies. Writing in the journal Nature, the researchers show that a certain class of antibodies in a monkey's blood predicted protection from COVID-19. If that hold true for humans, a relative simple blood test may show whether an experimental vaccine is working. Here's the dilemma: Once a vaccine is approved, it's unethical to test it against a placebo. Approving new vaccine would require researchers to compare two vaccines against each other, instead of having a vaccine and a placebo--which would take a lot more people than the 30,000 for the initial trials.
4th Dec 2020 - NPR

Multidose COVID-19 vaccines will test state tracking systems

When the COVID-19 vaccine becomes available in the United States, officials’ first challenge is getting the people in the door for their shots. Then, they’ll have a second problem: making sure they come back again to get a second dose of the same vaccine. With two two-dose vaccines headed for authorization, the logistical challenges of a vaccination program are only magnified. “You don’t want to have someone get the first dose of one brand of vaccine, and a second dose of another,” says Ben Moscovitch, project director of health information technology at The Pew Charitable Trusts. Assuming the Food and Drug Administration authorizes the vaccines after they review the data later this month, states will start to receive shipments of the Pfizer and BioNTech vaccine on December 15th, and the Moderna vaccine on December 22nd. From there, it’s up to states to distribute the vaccines. Both take two doses, given a few weeks apart, and both could be circulating at the same time. And that’s just the two front-runners. Other multidose vaccines are still in the development pipeline.
4th Dec 2020 - The Verge

Claims and counterclaims over alleged adverse reaction in covid-19 vaccine in India

The Indian manufacturer of the Oxford-AstraZeneca candidate vaccine against covid-19 (the Serum Institute of India) has threatened to claim Rs1bn (£10m; €11.2m; $13m) in damages from a clinical trial volunteer who alleges he developed a neurological illness after receiving the vaccine and has claimed Rs50m compensation. The Serum Institute of India, which is also conducting a clinical trial to assess the vaccine’s safety and immunogenicity in India, has said that the volunteer’s claim is “malicious and misconceived” because he was specifically informed by the medical team that the complications he suffered were independent of the trial. Indian health officials said on 1 December—over six weeks after the volunteer reported the illness—that probes by the institutional ethics committee, the data safety monitoring board, and India’s drug regulatory authority had found no correlation between the serious adverse event and the vaccine. Balram Bhargava, India’s department of health research secretary and director general of the Indian Council of Medical Research, said: “The initial causality assessment findings did not necessitate the stoppage of the trial.”
4th Dec 2020 - The BMJ

Moscow key workers register for jabs of Russian-made COVID-19 vaccine

Muscovites from high-risk groups such as healthcare workers began registering for jabs of a Russian-made COVID-19 vaccine on Friday, two days after President Vladimir Putin called for large-scale vaccinations. Sputnik V, one of two Russian-made vaccines to have received regulatory approval in Russia despite clinical trials being incomplete, requires two injections. Interim trials showed it is 92% effective at protecting people from COVID-19. Mass testing for the second Russian vaccine, EpiVacCorona, began on Monday. The online registration service allows Moscow residents in specified high-risk jobs and aged between 18 and 60 to book free vaccination appointments at 70 points around the city, starting from Saturday, the mayor’s website said.
4th Dec 2020 - Reuters UK

Moderna CEO confident of producing 500 million COVID-19 vaccine doses in 2021

Moderna Inc will be able to produce 500 million doses of its COVID-19 vaccine in 2021, Chief Executive Officer Stéphane Bancel said on Friday. The company has submitted applications seeking emergency use authorization in the United States and the European Union after full results from a late-stage study showed the vaccine was 94.1% effective with no serious safety concerns. “For 500 million, I am very comfortable we are gonna get there (2021),” Bancel said at the Nasdaq Investor Conference.
4th Dec 2020 - Reuters UK

Researchers hunt for clues in our blood to discover COVID-19 vaccines of the future

As these vaccines near the finish line, scientists will face a predicament: Successful authorization of the first vaccines will make it difficult, if not impossible, to continue to study COVID-19 vaccines of the future. Now, a group of researchers say they are zeroing in on a possible solution. By studying monkeys, they say they've identified a clue in our immune systems -- a signature that could show if a vaccine is working. If their results pan out in humans, the findings could help researchers side-step the need for massive, phase 3, placebo-controlled clinical trials, like the ones that are being conducted today for the current COVID-19 vaccines.
4th Dec 2020 - ABC News

Eceptionist launches self-service COVID-19 vaccine management tool

Global health care software provider Eceptionist has launched a new web-based solution to help private and public organizations manage COVID-19 vaccine distribution. Dubbed VaxManager, the software as a service (SAAS) solution alleviates the administrative burden of managing COVID tests, flu shots, and other vaccines when they become available. VaxManager incorporates an organization's COVID guidelines into a test/vaccine request workflow to automatically screen and prioritize vaccine and test requests, the company said. The mobile-friendly platform also includes a self-registration and self-request portal for patients to ensure quick and easy onboarding. Automated appointment reminders, follow-up notifications, and post-testing and post-vaccine information make the software highly reliable and relevant for patients.
4th Dec 2020 - IT PRO

Norway to use three vaccines to stop COVID-19 from early 2021

Norway plans to use the three vaccines developed by Moderna, AstraZeneca, Pfizer and BioNTech in its first push to inoculate its population against COVID-19, Norway’s health minister said on Friday. In the first quarter of 2021, Oslo expects to receive a total of 2.5 million doses, covering 1.25 million people - or 23% of the population, pending approval of the vaccines from European regulators. The doses would roughly cover the 1.3 million people in Norway who are considered in risk groups, Health Minister Bent Hoeie said, while the 340,000 health personnel in contact with patients would have to wait.
4th Dec 2020 - Reuters

Fortune or foresight? AstraZeneca and Oxford's stories clash on COVID-19 vaccine

The discrepancy, reported for the first time by Reuters, centres on the regimen administered to a smaller group of volunteers in the late-stage trials, of half a dose followed by a full dose. This diverged from the original plan of two full doses, given to the majority of participants. The half-dose pattern was found to be 90% effective, versus the 62% success rate of the two-full-dose main study, based on interim data. AstraZeneca’s research chief told Reuters 10 days ago, when interim trial data was released, the half-dose was given inadvertently as a first shot to some trial participants, and emerged as a stroke of fortune - “serendipity” - that scientists expertly harnessed.
3rd Dec 2020 - Reuters UK

China's COVID-19 Vaccine Development and Availability

China’s COVID-19 vaccines expected to be rolled out soon; bulk manufactured and exported in 2021. China could likely mass inoculate citizens in any outbreak that crosses a certain threshold; country expected to develop herd immunity over longer term. Sinovac vaccine (in limited roll-out) costs RMB 400.
3rd Dec 2020 - China Briefing

Pfizer chairman: We're not sure if someone can transmit virus after vaccination | TheHill

Pfizer chairman Albert Bourla told Dateline host Lester Holt that the pharmaceutical company was “not certain” if the vaccine prevented the coronavirus from being transmitted, saying, “This is something that needs to be examined.” In a prime-time special titled “Race for a Vaccine” set to air Thursday, Holt questioned Bourla and other individuals involved in the development and distribution of the medicine. In November, Pfizer announced that its vaccine candidate had been shown to be more than 90 percent effective at preventing COVID-19 and has applied for emergency use authorization from the Food and Drug Administration (FDA).
3rd Dec 2020 - The Hill


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Dec 2020

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Turkey announces vaccination plan for Chinese CoronaVac

Turkey’s health minister has announced a plan to start using an experimental Chinese COVID-19 vaccine later this month amid a surge in infections and deaths. Fahrettin Koca had previously announced an agreement with China’s Sinovac Biotech for 50 million doses of CoronaVac, which is currently in late-stage trials. Koca said in a statement late on Wednesday the first shipment of the vaccine will arrive in Turkey after December 11. The minister said early use authorisation would be granted after Turkish labs confirm the shots are safe and after assessment of initial results from the latest trials. “If developments continue positively as we expect, Turkey would be among the first countries in the world to begin vaccinations in the early phase,” Koca said.
4th Dec 2020 - AlJazeera

How UK approved BioNTech/Pfizer vaccine ahead of EU

Since October, when the first data from the BioNTech/Pfizer trial became available, scientists and clinicians at the UK Medicines and Healthcare products Regulatory Agency, or MHRA, had “worked round the clock” to review more than 1,000 pages of information, according to June Raine, the agency’s chief executive. Normally each stage of a clinical trial must be completed before the next stage begins, but the BioNTech/Pfizer trial had been adapted by the companies to allow the different trial stages to “overlap”, Ms Raine said. The MHRA then undertook a rolling review of the data, she said, to allow for the assessment of the vaccine “in the shortest time possible”.
4th Dec 2020 - Financial Times

Public trust vital for Covid-19 vaccine programmes, says WHO

The WHO has urged European countries to prepare for vaccinations against Covid-19, stressing that community acceptance will be crucial to the success of the health programmes. More than 200 Covid vaccines are under development, some of which have already completed phase 3 clinical trials with an efficacy rate of more than 90%. This week the UK became the first country to approve the Pfizer/BioNTech vaccine against Covid-19. The UK’s Medicines and Healthcare products Regulatory Agency is also reviewing vaccines from the US company Moderna and the Oxford University/AstraZeneca team.
3rd Dec 2020 - The Guardian

Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results

At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.
3rd Dec 2020 - nejm.org

Covid-19 vaccine: First jabs 'could cut 99% of deaths' - Jonathan Van-Tam

Up to 99% of Covid-19 hospitalisations and deaths could be avoided with the first wave of vaccinations, England's deputy chief medical officer Prof Jonathan Van-Tam has said. Speaking to BBC News, he said that would be possible if everyone on the first priority list took the vaccine and it was highly effective. He said it was key to go "as fast" and at the "highest volume" as possible. But he acknowledged there would need to be some flexibility in the list. On Wednesday the UK became the first country in the world to approve the Pfizer/BioNTech vaccine for use. The BBC understands that some of the first delivery of the Pfizer vaccine is travelling via the Eurotunnel to the UK on Thursday.
3rd Dec 2020 - BBC

Italy curbs Christmas travel to avoid virus 'third wave'

Italy on Thursday announced national travel restrictions for the Christmas holidays designed to limit the spread of COVID-19 in the European country first hit by the pandemic. The new rules, together with an existing curfew and other regulations already in place, seek to curb circulation throughout the country during the festive period by limiting the number of gatherings. Earlier this year, a punishing lockdown of all Italy's 60 million residents helped bring the outbreak under control, but the government is trying to avoid missteps made over the summer after the lockdown lifted, when the return of vacationers fuelled a new rise in cases.
3rd Dec 2020 - Medical Xpress

Inside China's response to COVID

Since SARS-CoV-2 was first reported in China almost a year ago, policymakers have swung the weight of the state’s resources towards developing a vaccine. Their approach, alongside similar efforts in other countries, has thrown a spotlight on immunology, epidemiology and virology, bringing increased funding, prestige and public interest. Conversations with Chinese immunologists, policymakers and funders — including some who asked not to be named so they could speak more freely — reveal a complex picture of science mixed with international politics. Scientists, drug developers and research institutions are racing to tackle the virus. But some are concerned about the cost of rapid progress, and the incentives that have been created for companies and researchers to rush their work.
3rd Dec 2020 - Nature.com

How is China beating covid-19 and are the reported numbers reliable?

As the second wave of the covid-19 pandemic worsens across the northern hemisphere, life has largely returned to normal in the country where the virus first made its mark. Restaurants and markets in Chinese cities are bustling, as are tourist sites and cinemas. In Wuhan, where a lockdown in late January first shocked and then became a precedent for the rest of the world, recent months have seen packed concerts, food festivals and pool parties.
3rd Dec 2020 - New Scientist

'Corners weren't cut': WHO doctor says that Covid-19 vaccines were not rushed

World Health Organisation (WHO) spokesperson Dr Margaret Harris has said that Covid-19 vaccines have not been rushed. The science that was needed to develop them was already there from the time of Sars and Murs. “Corners haven’t been cut,” she told RTÉ radio’s Morning Ireland. The regulatory authorities were kept up to date during the development process so they were able to move swiftly on seeing the final data.
3rd Dec 2020 - Irish Examiner

Incomplete data stalls Swiss authorisation of Covid-19 vaccines

Switzerland’s medical regulator Swissmedic says it lacks the necessary information to sign off on three different coronavirus vaccines ordered by the government. The regulator said important data on safety, efficacy and quality are still missing. It has reached out to the manufacturers, who provided data from their studies. “We lack data on the effectiveness of the clinical trials and on the important subgroups that participated in these large studies,” said Claus Bolte, head of the authorisation division at Swissmedic, at a press briefing on Tuesday organised by the Federal Office of Public Health. For example, Swissmedic wants to know about the pre-existing illnesses of the people who took part in these studies. According to the regulator, acceptance of such rapidly developed vaccines requires a high degree of trust in manufacturers and approving authorities. It is therefore important to examine very closely the effects on different groups of people.
3rd Dec 2020 - Swissinfo.ch

Bill Gates warns the next five months will be 'pretty grim' for US - as he vows to immediately take a COVID-19 vaccine and officials say Americans will be given vaccination cards to show they've had the shots

Bill Gates said the next five months look 'pretty grim' for the United States unless COVID-19 stops surging across the country. The billionaire philanthropist said things could likely return to normal by the spring if Americans doubled down on public health measures now. He also vowed to immediately take a COVID-19 vaccine once it's available to him. It comes as health officials revealed yesterday that Americans will likely be armed with a COVID-19 vaccine card to keep track of the shots.
3rd Dec 2020 - Daily Mail

Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain Obstacles

When Pfizer Inc. said last month it expects to ship half the Covid-19 vaccines it had originally planned for this year, the decision highlighted the challenges drug makers face in rapidly building supply chains to meet the high demand. “Scaling up the raw material supply chain took longer than expected,” a company spokeswoman said. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”
3rd Dec 2020 - The Wall Street Journal

Moderna plans to test COVID-19 vaccine on children

Moderna is planning to test the effects of its COVID-19 vaccine on children. Its study will include administering two doses of the vaccine within 28 days to 3,000 children aged 12 to 17. Earlier this week, the United Kingdom became the first country to grant emergency use to the Pfizer-BioNTech coronavirus vaccine, raising hopes that an end to the global pandemic, which has seen almost 65 million people infected and nearly 1.5 million deaths, might be in sight. Moderna, an American firm, said this week it would apply to United States and European regulators to grant emergency use of its COVID-19 vaccine after further evidence confirmed the efficacy of its jab stood at more than 94 percent. Neither vaccines can be injected in children and pregnant women.
3rd Dec 2020 - AlJazeera


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Dec 2020

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These Covid-19 Vaccines Are Safe, Right?

Sam Fazeli, a Bloomberg Opinion contributor who covers the pharmaceutical industry for Bloomberg Intelligence, answered questions about the safety of new Covid-19 vaccines that are set to win approval for broad use in the U.S., Europe and elsewhere as early as this month. The conversation has been edited and condensed.
2nd Dec 2020 - Bloomberg

Covid-19: Pfizer/BioNTech vaccine judged safe for use in UK from next week

The UK has become the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine, paving the way for mass vaccination. Britain's medicines regulator, the MHRA, says the jab, which offers up to 95% protection against Covid-19 illness, is safe to be rolled out. The first doses are already on their way to the UK, with 800,000 due in the coming days, Pfizer said. Health Secretary Matt Hancock said the NHS will contact people about jabs. Elderly people in care homes and care home staff have been placed top of the priority list, followed by over-80s and health and care staff. But because hospitals already have the facilities to store the vaccine at -70C, as required, the very first vaccinations are likely to take place there - for care home staff, NHS staff and patients - so none of the vaccine is wasted. A further 648 deaths within 28 days of a positive Covid-19 test were recorded in the UK on Wednesday, with another 16,170 cases reported.
2nd Dec 2020 - BBC

U.K. Authorizes Pfizer, BioNTech’s Covid-19 Vaccine for Emergency Use

The U.K. became the first Western nation to grant emergency-use authorization for a Covid-19 vaccine, clearing a shot developed by Pfizer Inc. of the U.S. and BioNTech SE of Germany to be distributed in limited numbers within days. The two-shot vaccine is also being reviewed by the Food and Drug Administration in the U.S., where a similar authorization could come later this month and a rollout before the end of the year. The U.K. green light on Wednesday punctuates a monthslong sprint by the two drugmakers, which teamed up earlier this year and then pulled ahead of two other Western pharmaceutical companies, each with its own promising shot. Vaccines typically take years to bring to market.
2nd Dec 2020 - The Wall Street Journal

Have countries led by women coped better with Covid-19?

Eight months ago, the tooth fairy flitted into New Zealand politics. During a national address, the country’s premier Jacinda Ardern declared that, although she was placing the population into a tight lockdown to combat Covid-19, “We do consider both the tooth fairy and the Easter bunny to be essential workers.” The video of her speech went viral. Was this just a piece of political theatre? Perhaps. But the humour, care and humanity it showed raise an intriguing question: have female leaders been better at rallying their voters to combat the pandemic than men?
2nd Dec 2020 - The Financial Times

Beware fake coronavirus vaccines, says Interpol

Interpol has issued a global alert to law enforcement agencies around the world warning them that organised crime networks may try to sell fake Covid-19 vaccines or steal real supplies. The global police coordination agency, based in France, said on Wednesday it had issued an orange alert to police forces in its 194 member states warning them to prepare for vaccines to be targeted both physically and online.
2nd Dec 2020 - The Guardian

C.D.C. Recommends That Nursing Homes and Health Workers Get Vaccines First

An independent panel advising the Centers for Disease Control and Prevention voted Tuesday to recommend that residents and employees of nursing homes and similar facilities be the first people in the United States to receive coronavirus vaccines, along with health care workers who are especially at risk of being exposed to the virus. The panel, the Advisory Committee on Immunization Practices, voted 13 to 1 during an emergency meeting to make the recommendation. The director of the C.D.C., Dr. Robert R. Redfield, is expected to decide by Wednesday whether to accept it as the agency’s formal guidance to states as they prepare to start giving people the shots as soon as two weeks from now.
2nd Dec 2020 - The New York Times

U.K. approves Pfizer-BioNTech vaccine for rollout from 'next week'

The U.K. on Wednesday became the first Western country to approve a COVID-19 vaccine for general use as it announced a rollout of Pfizer-BioNTech’s drug from next week. “The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s Covid-19 vaccine for use,” the department of health said in a statement. “The vaccine will be made available across the UK from next week,” the statement said. Priority groups will include care home residents, health and care staff, the elderly and the clinically extremely vulnerable.
2nd Dec 2020 - The Japan Times

New research: Mass screening finds over 300 asymptomatic cases in Wuhan

The mass testing project took place over two weeks at the end of May - after the city's stringent lockdown was lifted in April. The study found no 'variable' virus in the asymptomative cases, and the close contacts of these positive asymptomatic cases did not test positive.
2nd Dec 2020 - The Indian Express

China ‘gives North Korea’s Kim Jong-un and family experimental Covid vaccine’

North Korean leader Kim Jong-un, his family and several top-ranking officials in his administration have been provided with an experimental coronavirus vaccine by China, an analyst has claimed. “Kim Jong-un and multiple other high-ranking officials within the Kim family and leadership network have been vaccinated for coronavirus within the last two to three weeks thanks to a vaccine candidate supplied by the Chinese government,” said Harry Kazianis, a North Korea expert who works at the Washington-based think tank Center for the National Interest. He revealed the information in an article on news outlet 19FortyFive, citing two unidentified Japanese intelligence sources. But the intelligence sources did not reveal the name of the company whose experimental vaccine was administered to the North Korean leader and his officials.
2nd Dec 2020 - The Independent

UK becomes first country to approve Pfizer/BioNTech's Covid-19 vaccine, first shots roll out next week

The United Kingdom has become the first Western nation to authorize a Covid-19 vaccine, a landmark moment in the coronavirus pandemic that paves the way for the first doses to be rolled out across the country next week. "Help is on the way," Health Secretary Matt Hancock announced Wednesday morning, after UK regulators granted emergency authorization for a vaccine made by US pharmaceutical giant Pfizer and its German partner BioNTech. A final analysis of the Phase 3 trial of the vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer said last month
2nd Dec 2020 - CNN

Pfizer/BioNTech vaccine authorised for use in the UK

People in care homes may be first in UK to get authorised Pfizer/BioNTech vaccine The UK government has become the first in the world to give the Pfizer/BioNTech covid-19 vaccine temporary authorisation for emergency use. The UK has pre-ordered 40 million doses – enough for 20 million people at most, as it is a two-shot vaccine – and will start to vaccinate people possibly as early as next week. To distribute the vaccine, Pfizer has designed special cardboard boxes that can be packed with dry ice, enabling the vaccine doses to be kept at -70°C during transport. They can then be stored in a normal fridge for up to five days. This afternoon the Joint Committee on Vaccinations and Immunisations (JCVI) released its advice on who will receive priority for the vaccine. It recommended that priority be given first to care home residents and their carers, then to frontline health and social care workers and people aged 80 and over. People 75 and over will be next, followed by those aged 70 and above and people who are clinically extremely vulnerable. The vaccine will not be given to pregnant women or to most children under 16, because there is no safety data for these groups.
2nd Dec 2020 - New Scientist

Coronavirus: UK approves Pfizer-BioNTech vaccine, to roll out next week

Britain on Wednesday said it had approved the Pfizer-BioNTech vaccine for use and that it will be rolled out from next week. "The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech's COVID-19 vaccine for use," the government said. "The vaccine will be made available across the UK from next week." The move makes Britain one of the first countries to begin the process of vaccinating its population as it tries to curb the COVID-19 outbreak. Prime Minister Boris Johnson said COVID-19 vaccines will "allow us to reclaim our lives."
2nd Dec 2020 - Deutsche Welle

Researchers determine how the SARS-CoV-2 virus hijacks and rapidly causes damage to human lung cells

In a multi-group collaborative involving the National Emerging Infectious Disease Laboratories (NEIDL), the Center for Regenerative Medicine (CReM), and the Center for Network Systems Biology (CNSB), scientists have reported the first map of the molecular responses of human lung cells to infection by SARS-CoV-2. By combining bioengineered human alveolar cells with sophisticated, highly precise mass spectrometry technology, Boston University School of Medicine (BUSM) researchers have identified host proteins and pathways in lung cells whose levels change upon infection by the SARS-CoV-2, providing insights into disease pathology and new therapeutic targets to block COVID-19.
2nd Dec 2020 - Phys.org

Largest Clinical Trial in Africa to Treat COVID-19 Cases is Launched in 13 Countries

African countries and an international network of research institutions, including the Swiss Tropical and Public Health Institute (Swiss TPH), have joined forces to launch the largest COVID-19 clinical trial in mild-to-moderate outpatients in Africa. The ANTICOV clinical trial aims to respond to the urgent need to identify treatments that can be used to treat mild and moderate cases of COVID-19 early and prevent spikes in hospitalisation that could overwhelm fragile and already overburdened health systems in Africa.
24th Nov 2020 - Swiss Tropical Public Health Institute

AstraZeneca U.S. COVID-19 vaccine trial results likely in late-Jan, says health official

AstraZeneca Plc will likely get results of its U.S. COVID-19 vaccine trial in late-January and could potentially file for an emergency authorization, the chief adviser for the U.S. government’s Operation Warp Speed program said on Wednesday. The British drugmaker and Oxford University have already published interim efficacy results from their UK trial in November, but the results have raised questions among scientists. The company said the vaccine could be 90% effective when given as a half dose followed by a full dose, based on a relatively small number of volunteers, while overall effectiveness was around 70%. Speaking at a U.S. Department of Health and Human Services meeting, OWS chief adviser Moncef Slaoui said the large set of contrasting data coming out from the UK and Brazil trials may not be enough to ensure the vaccine receives the U.S. Food and Drug Administration’s emergency use authorization.
2nd Dec 2020 - Reuters UK

Medical journal editorial refutes WHO finding on Gilead's remdesivir for COVID-19

An editorial in the influential New England Journal of Medicine cites problems with a World Health Organization (WHO) study that found Gilead Sciences Inc’s antiviral remdesivir failed to improve COVID-19 survival, and said it does not refute trials that demonstrated benefits of the drug in treating the illness. The editorial, by David Harrington at the Harvard T.H. Chan School of Public Health, infectious disease specialist Dr. Lindsey Baden and Brown University biostatistician Joseph Hogan, was published on Wednesday along with the WHO study. They noted that the trial called Solidarity, which looked at four drugs, was conducted in 30 countries ranging from Switzerland and Germany to Iran and Kenya, leading to inconsistencies in the data collected.
2nd Dec 2020 - Reuters

COVID-19 Vaccines Make Some Health Care Workers Wary : Shots - Health News

Health care workers are expected to be first in line to be offered a COVID-19 vaccine when one is available. It makes sense: Getting a safe, effective vaccine would help keep them and their patients healthy. Seeing doctors, nurses and medical aides getting COVID-19 vaccines would also set an example for the community. But the speed of COVID-19 vaccine development, along with concerns about political interference with the process, has left some health care workers on the fence about COVID-19 vaccines. So many health care workers are expressing concerns and anxiety about getting COVID-19 vaccines that the Centers for Disease Control and Prevention says addressing hesitancy in this group is a top priority. A CDC survey, shared at a public meeting of its vaccine advisory committee on Nov. 23, found that 63% of health care workers polled in recent months said they would get a COVID-19 vaccine.
1st Dec 2020 - NPR


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Dec 2020

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Health-care workers and nursing home residents should be the first to get coronavirus vaccines, CDC advisory group says

The first doses of a coronavirus vaccine should be given to an estimated 21 million health-care workers and 3 million residents and staff of nursing homes and other long-term care facilities, a federal advisory panel recommended Tuesday afternoon. These groups were deemed the highest priority by the Advisory Committee on Immunization Practices, because the vaccine will initially be in extremely short supply after it is cleared by federal regulators. Health-care personnel are a top priority because of their exposure to the virus and their critical role of keeping the nation’s hospitals and clinics functioning. Residents and employees of long-term care facilities were prioritized because they account for nearly 40 percent of deaths from covid-19, the disease caused by the coronavirus.
2nd Dec 2020 - The Washington Post

EU Commission to authorise COVID-19 vaccines days after regulatory approval

The European Commission is likely to give the final authorisation for the roll-out of COVID-19 vaccines days after the EU drug regulator approves them, a spokesman for the EU executive said on Tuesday. The European Medicines Agency (EMA) said earlier on Tuesday it planned to decide whether to approve the vaccine being developed by Pfizer and BioNTech by Dec 29, and by Jan. 12 on the shot being developed by Moderna. “It’s probably a matter of days. The goal is to do it rapidly,” the spokesman told a news conference, adding the exact date depended on the EMA’s possible authorisations.
1st Dec 2020 - Reuters

Pfizer, Moderna Request Covid-19 Vaccine Authorization in Europe

Pfizer Inc. partner BioNTech and U.S. drugmaker Moderna Inc. both applied for their coronavirus vaccines to be approved in the European Union, the EU’s chief medicines regulator said Tuesday, with officials expected to make a decision on at least one of the vaccines by the end of the month. The announcement brings hope that the EU will soon be able to start vaccinating its 448 million people against a disease that has done some of its earliest and worst damage on the continent.
1st Dec 2020 - The Wall Street Journal

Leaked documents show China lied about Covid-19 case totals and mishandled pandemic

China underreported Covid-19 numbers by more than half as it downplayed the severity of the virus and their failure to quickly diagnose cases in the early stages of the pandemic, according to leaked documents. A series of revelations in 117 pages of internal documents from the Hubei Provincial Centre for Disease Control and Prevention, obtained by CNN, shows how the Chinese Communist Party withheld vital information as the world grappled to contain the rapidly spreading virus. On 10 February, China publicly reported 2,478 new confirmed cases while privately documenting 5,918 new cases – a 139 per cent difference. On 17 February, China publicly reported new deaths in Hubei province, where the pandemic is believed to have originated in Wuhan, at 93 while privately reporting 196 – a difference of more than double.
1st Dec 2020 - The Independent

Covid-19: Lung damage 'identified' in study

Researchers made a mathematical model to find the daily disease growth rate European nations took 9 days to bring in lockdown from first death, on average In nine days, epidemic size grows by a factor of ten, the researchers say
1st Dec 2020 - BBC

Britain DID lockdown too late in March: UK's coronavirus epidemic grew five times more than the European average between first the Covid death and the start of lockdown, study ...

Researchers made a mathematical model to find the daily disease growth rate European nations took 9 days to bring in lockdown from first death, on average In nine days, epidemic size grows by a factor of ten, the researchers say
1st Dec 2020 - Daily Mail

Germany says coronavirus vaccine will be safe

The same rigorous approval standards are being applied to the coronavirus vaccine candidates as for other medicines, Germany’s science minister has said, adding that any approved jab will be voluntary. Anja Karliczek said the key to gaining widespread public support for the immunisation is ensuring the same standards are applied across the board. Authorities will educate the public about any possible side effects that could occur after vaccination, including headaches, localised pain and fever. Vaccination against the virus will not be mandatory, Ms Karliczek said. The rapid pace of the vaccines’ development is down to huge efforts by scientists, as well as early funding and experience from previous vaccines, Marylyn Addo, a doctor at Hamburg's UKE hospital who is working in vaccine trials, said.
1st Dec 2020 - The Independent

UEA study shows Chinese asymptomatic Covid-19 cases were not infectious

Researchers from Norwich have found a mass screening programme of more than 10 million people in the Chinese city of Wuhan identified 300 asymptomatic Covid-19 cases - but none were infectious. But the University of East Anglia scientists stressed the findings do not show people who have coronavirus, but no symptoms, cannot pass on the virus. Mass testing took place over two weeks at the end of May – after the city’s stringent lockdown was lifted in April. The study found no ‘viable’ virus in the asymptomatic cases and their close contacts did not test positive. Prof Fujian Song, from UEA’s Norwich Medical School, said: “The virus cultures indicated no viable virus in the identified asymptomatic cases. This means that these people were not likely to infect anyone else.”
1st Dec 2020 - Eastern Daily Press

Analysis: COVID-19 worsens Europe's inequalities in yet another way - the fertility gap

“It’s time to become a mum,” was the push-notification hundreds of Portuguese women received on their cell phones last month. The text, sent by a private hospital in Lisbon trying to drum up clients for its maternity unit, caused outrage on social media, with some women saying that the middle of a pandemic and recession is the worst possible time to have a baby. Evidence suggests the coronavirus is deterring would-be parents from conceiving in most of Europe, but especially in the southern countries - from Italy to Greece - where safety nets are weakest and the birth rate was already in strong decline.
1st Dec 2020 - Reuters

Deliver a safe, effective COVID-19 vaccine in less than a year? Impossible. Meet Moncef Slaoui.

In 2009, a flu pandemic was racing across the world when a venture capital firm that backs health care companies held its annual retreat. The meeting was a who's who of pharmaceutical and biotechnology executives – the top leaders of the top companies in the world.
1st Dec 2020 - MSN.com

Europe’s medical agency eyes safety of two COVID-19 vaccines

The European Medicines Agency has said it would convene a meeting on December 29 to decide if there is enough data about the safety and efficacy of the COVID-19 vaccine developed by Pfizer and BioNTech for it to be approved. The agency also said on Tuesday it could decide as early as January 12 whether to approve an experimental COVID-19 vaccine developed by Moderna Inc.
1st Dec 2020 - AlJazeera

Novavax expects delayed U.S. COVID-19 vaccine trial to start in coming weeks

Novavax Inc on Monday pushed back the start of a U.S.-based, late-stage trial for its experimental COVID-19 vaccine for the second time and now expects it to begin in the coming weeks instead of November. While the U.S. trial has been hampered by issues in scaling up the vaccine’s manufacturing, Novavax has a late-stage study underway in the UK which finished enrollment on Monday. Shares of the U.S.-based company were up 10% in late-afternoon trading. The U.S. trial delay was not meaningful and it could provide more information into Novavax’s “second-generation” vaccine that already lags behind larger rivals, said Cantor Fitzgerald analyst Charles Duncan.
30th Nov 2020 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Dec 2020

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'No-swab' coronavirus test from OptiGene highly sensitive, UK says

A type of COVID-19 test that can be taken without the need for a nose or throat swab has been found to be highly effective in identifying infectious cases, including for people not showing symptoms, the British government said on Tuesday. The RT-LAMP tests, made by privately-held British company OptiGene, have been studied in a pilot programme in the southern English city of Southampton, where they were used to test some health service staff as well as 55,000 people connected to the local university. “We’ve shown through carefully conducted studies that the OptiGene LAMP test is fast, reliable and easy to use, and dependent on testing format can work directly with saliva samples as well as with swabs,” said Sue Hill, chief scientific officer for England in the National Health Service’s Test and Trace programme.
1st Dec 2020 - Reuters UK

Moderna Soars on Plans to Seek Clearance for Covid Vaccine

FDA advisory panel to review data on Dec. 17, agency says - Vaccine was 94.1% effective in final analysis of 196 cases. Moderna Inc. requested clearance for its coronavirus vaccine in the U.S. after a new analysis showed the vaccine was highly effective in preventing Covid-19, with no serious safety problems. A Moderna spokesman said in a text message late afternoon Monday that its application for an emergency use authorization for its Covid shot had been delivered to the U.S. Food and Drug Administration. Earlier, the company had said in a statement it would seek clearance on Monday in both the U.S. and Europe.
30th Nov 2020 - Bloomberg

Moderna to Ask Health Regulators to Authorize Its Covid-19 Vaccine

Moderna said it would ask U.S. and European health regulators Monday to authorize use of its Covid-19 vaccine, after it was shown to be 94.1% effective in a full analysis of a pivotal study. The timing keeps the vaccine on track to become possibly the second to go into use in the U.S. by year’s end—after one already under regulatory review from Pfizer Inc. and BioNTech SE —with inoculation available to the general public likely in spring or summer. Moderna said some doses also could become available in Europe in December. In the 30,000-person trial, 196 subjects developed Covid-19 with symptoms after receiving either the vaccine or a placebo, Moderna said. Of those, 185 had taken a placebo, while only 11 had gotten the vaccine, indicating it protects against the disease.
30th Nov 2020 - The Wall Street Journal

Moderna's Covid-19 vaccine is 94.1% effective in final results

CNBC’s Meg Tirrell reports on the latest efficacy data from Moderna’s coronavirus vaccine.
30th Nov 2020 - CNBC

Moderna becomes second company to request emergency FDA authorization for COVID-19 vaccine candidate

Biotech company Moderna applied Monday for an emergency use authorization from the U.S. Food and Drug Administration after receiving more good news about the safety and effectiveness of its candidate COVID-19 vaccine. Moderna will be the second vaccine maker to request authorization from the federal government after similarly positive results for Pfizer and its German collaborator BioNTech's candidate vaccine. Moderna's latest findings, according to a company press release, showed that of 196 people in the clinical trial who caught COVID-19, 185 of them had received the placebo, while only 11 received the active vaccine. That works out to an effectiveness rate above 94%.
30th Nov 2020 - USA Today

Moderna to seek FDA emergency authorization after COVID-19 vaccine shows 94% efficacy in final analysis

Moderna announced Monday it will ask the Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 vaccine, making it the second company, after Pfizer, to seek EUA for a COVID-19 vaccine in the United States. Pfizer's public FDA hearing -- a crucial step in the authorization process -- is scheduled for Dec. 10, and the FDA could make its official authorization decision shortly thereafter. In an early morning press release, Moderna announced that its FDA hearing will be held a week later, on Dec. 17. Moderna also announced its coronavirus vaccine is more than 94% effective, according to the final analysis of its massive Phase 3 trial.
30th Nov 2020 - ABC

Perthshire professor calls on public to treat COVID-19 with "the seriousness it deserves"

In a video message, Professor James Chalmers said the virus is unpredictable in how it will affect people and “so dangerous because it can change very, very quickly.”
30th Nov 2020 - Daily Record

Federal system for tracking hospital beds and COVID-19 patients provides questionable data

In mid-November, as the United States set records for newly diagnosed COVID-19 cases day after day, the hospital situation in one hard-hit state, Wisconsin, looked concerning but not yet urgent by one crucial measure. The main pandemic data tracking system run by the Department of Health and Human Services (HHS), dubbed HHS Protect, reported that on 16 November, 71% of the state’s hospital beds were filled. Wisconsin officials who rely on the data to support and advise their increasingly strained hospitals might have concluded they had some margin left. Yet a different federal COVID-19 data system painted a much more dire picture for the same day, reporting 91% of Wisconsin’s hospital beds were filled. That day was no outlier. A Science examination of HHS Protect and confidential federal documents found the HHS data for three important values in Wisconsin hospitals—beds filled, intensive care unit (ICU) beds filled, and inpatients with COVID-19—often diverge dramatically from those collected by the other federal source, from state-supplied data, and from the apparent reality on the ground.
30th Nov 2020 - Science Magazine

UEA study shows Chinese asymptomatic Covid-19 cases were not infectious

Researchers from Norwich have found a mass screening programme of more than 10 million people in the Chinese city of Wuhan identified 300 asymptomatic Covid-19 cases - but none were infectious. But the University of East Anglia scientists stressed the findings do not show people who have coronavirus, but no symptoms, cannot pass on the virus. Mass testing took place over two weeks at the end of May – after the city’s stringent lockdown was lifted in April. The study found no ‘viable’ virus in the asymptomatic cases and their close contacts did not test positive. Prof Fujian Song, from UEA’s Norwich Medical School, said: “The virus cultures indicated no viable virus in the identified asymptomatic cases. This means that these people were not likely to infect anyone else.”
30th Nov 2020 - Norwich Evening News

Coronavirus: Dr Anthony Fauci praises Australia's handling of crisis

Australia praised for its handling of the coronavirus pandemic by a top doctor. Dr Anthony Fauci applauded Australia's use of lockdowns to suppress the spread. Dr Fauci raised fears that the worst may be yet to come in the United States. He said Australia's uniform public health measures also helped control the virus
30th Nov 2020 - Daily Mail

Russia begins mass trials of second coronavirus vaccine

Russia plans to begin mass trials of its second coronavirus vaccine, EpiVacCorona, on people aged over 18 on Monday, the RIA news agency cited the consumer health watchdog Rospotrebnadzor as saying. EpiVacCorona, which is being developed by Siberia’s Vector Institute, was authorised this month to carry out trials on 150 volunteers over 60 and 3,000 volunteers over 18, the watchdog has said.
30th Nov 2020 - Reuters UK

'Absolutely remarkable': No one who got Moderna's vaccine in trial developed severe COVID-19

Continuing the spate of stunning news about COVID-19 vaccines, the biotech company Moderna announced the final results of the 30,000-person efficacy trial for its candidate in a press release today: Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago. More impressive still, Moderna’s candidate had 100% efficacy against severe disease. There were zero such COVID-19 cases among those vaccinated, but 30 in the placebo group. The company today plans to file a request for emergency use authorization (EUA) for its vaccine with the U.S. Food and Drug Administration (FDA), and is also seeking a similar green light from the European Medicines Agency.
30th Nov 2020 - Science Magazine

Moderna files for U.S. vaccine authorization, will seek EU nod

Moderna Inc said on Monday it has applied for U.S. emergency authorization for its COVID-19 vaccine after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns. The U.S. Food and Drug Administration said an advisory committee would meet to discuss the request on Dec. 17, making Moderna’s candidate the second highly effective vaccine likely to receive U.S. regulatory backing and a potential roll out this year. A shot developed by Pfizer Inc and BioNTech SE that was 95% effective in its pivotal trial is set to be reviewed by a panel of outside experts a week earlier. The FDA will decide on the emergency use authorizations (EUA)after the advisers make their recommendations.
30th Nov 2020 - Reuters UK

Singapore studies COVID-19 pregnancy puzzle after baby born with antibodies

Doctors are studying the impact of COVID-19 on pregnant women and their unborn babies in Singapore, where an infant delivered by an infected mother earlier this month had antibodies against the virus but did not carry the disease. The ongoing study among the city-state’s public hospitals adds to international efforts to better understand whether the infection or antibodies can be transferred during pregnancy, and if the latter offers an effective shield against the virus. The World Health Organisation says while some pregnant women have an increased risk of developing severe COVID-19, it is not yet known whether an infected pregnant woman can pass the virus to her foetus or baby during pregnancy or delivery.
30th Nov 2020 - Reuters

Global pandemic has led to chronic loneliness in young people, study finds

The global pandemic has caused chronic loneliness and social isolation in young people. Adolescents are also reporting high levels of anxiety about their future in terms of the impact of Covid-19 on their education, careers and family life. A major new global UNESCO study on the toll Covid-19 has had on young people is being spearheaded by NUI Galway, Professor Pat Dolan. Professor Dolan, Director of the UNESCO Child and Family Research Centre at NUI Galway is leading the research project with over 100 countries taking part. It is among the first global studies to have adopted the Youth As Researchers model.
30th Nov 2020 - Irish Independent

Covid Vaccines: 5 Things An Actual Scientist Wants Anti-Vaxxers To Know

And the recent flurry of positive news around vaccines has inevitably focused some of this misguided energy into the supposed harms and risks associated with inoculation, once again fuelling the anti-vax movement that began in the 1990s. Most of the concerns raised are old and already debunked news, repackaged for the social media age and propagated by non-experts. So HuffPost UK asked an actual expert, UCL medicine cell biologist Dr Jennifer Rohn, to help debunk the 2020 version of a 1990s phenomenon...
30th Nov 2020 - Huffington Post UK

Moderna asking US, European regulators to OK its virus shots

Moderna Inc. said Monday it was asking U.S. and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection — intensifying the race to begin limited vaccinations as the coronavirus rampage worsens. Multiple vaccine candidates must succeed for the world to stamp out the pandemic, which has been on the upswing in the U.S. and Europe. U.S. hospitals have been stretched to the limit as the nation has seen more than 160,000 new cases per day and more than 1,400 daily deaths. Since first emerging nearly a year ago in China, the virus has killed more than 1.4 million people worldwide.
30th Nov 2020 - AP

India investigates alleged AstraZeneca vaccine ‘adverse reaction’

The Indian Council of Medical Research (ICMR) is assisting an inquiry into an alleged adverse reaction during AstraZeneca’s COVID-19 vaccine trial but has found no reason to recommend halting it, a senior official at the regulator said. A 40-year-old man said in a complaint seen by Reuters news agency that he had suffered serious “neurological and psychological” symptoms after receiving the vaccine in a trial being run by the British drugmaker’s partner, the Serum Institute of India (SII). “There was no immediate cause of concern at this stage,” Samiran Panda, head of Epidemiology and Communicable Diseases at the ICMR, the research body involved in trials, told Reuters. “It doesn’t mean that long term assessment will not happen, it is still happening. I am aware of the activity,” Panda said. AstraZeneca did not respond to a request for comment. Law firm NGR Prasad & R Rajaram Advocates sent the complaint by the unnamed volunteer, who is seeking 50 million rupees ($676,288) in compensation and a suspension of testing, manufacturing and distribution of the vaccine, to ICMR, SII, AstraZeneca and the Drugs Controller General of India.
30th Nov 2020 - AlJazeera


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Nov 2020

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Singaporean mother gives birth to baby with COVID-19 antibodies

A Singaporean woman who was pregnant when she was infected with coronavirus in March has reportedly given birth to a baby with antibodies against the disease, offering a new clue as to whether the infection can be transferred from mother to child. The baby, who was was born this month, does not have COVID-19 but has the virus antibodies, the Straits Times newspaper reported on Sunday, citing the mother.
30th Nov 2020 - AlJazeera

Breakingviews - AstraZeneca’s messaging warrants a review, too

In the current environment, careful communication is critical. As many as 40% of Americans are unwilling to take a Covid-19 vaccine, according to an October Gallup poll. Although drug giants have vowed not to profit from coronavirus jabs during the pandemic, the speed of the vaccine rollouts itself breeds wariness. Things will get even more awkward if AstraZeneca’s new review finds its vaccine is less useful than assumed. Investors will be watching, too. AstraZeneca’s shares have fallen nearly 5% since it revealed its results on Monday. Big Pharma valuations are based on the ability to deliver new blockbuster drugs and developing a track record for delivering on your pledges is an integral part of the mix. AstraZeneca should bear that in mind when it gets the results of its latest review back.
30th Nov 2020 - Reuters UK

UK secures two million more doses of Moderna's COVID-19 vaccine

Britain has secured two million doses of Moderna Inc’s COVID-19 vaccine candidate, to be available in Europe as early as the spring, the government said on Sunday, in addition to the 5 million doses it secured from the U.S. company two weeks ago. The new deal came a day after Prime Minister Boris Johnson named Nadhim Zahawi, a junior business minister, to be minister responsible for the deployment of COVID-19 vaccines. Britain now has access to enough doses of Moderna’s vaccine candidate for around 3.5 million people. Overall, it has access to 357 million doses of vaccines from seven developers, according to government statement.
29th Nov 2020 - Reuters UK

CDC panel meets Tuesday to vote on COVID-19 vaccine priority

A panel of U.S. advisers will meet Tuesday to vote on how scarce, initial supplies of a COVID-19 vaccine will be given out once one has been approved. Experts have proposed giving the vaccine to health workers first. High priority also may be given to workers in essential industries, people with certain medical conditions and people age 65 and older. Tuesday's meeting is for the Advisory Committee on Immunization Practices, a group established by the Centers for Disease Control and Prevention. The panel of experts recommends who to vaccinate and when -- advice that the government almost always follows. Pfizer and its German partner BioNTech have asked the Food and Drug Administration to allow emergency use of its COVID-19 vaccine candidate. Moderna Inc. is expected to also seek emergency use of its vaccine soon.
28th Nov 2020 - The Independent

UK regulator set to approve Covid-19 vaccine next week

The UK is poised to become the first western country to approve a Covid-19 vaccine, with the independent regulator set to grant approval within days. Deliveries of the vaccine developed by BioNTech and Pfizer would begin within hours of the authorisation, according to government officials. The first injections could take place from December 7. The UK has ordered 40m doses of the two-shot product, which preliminary data found to be more than 95 per cent effective in preventing disease. Vaccines would normally be authorised by the European Medicines Agency until the end of the Brexit transition on December 31. However the UK’s Medicines and Healthcare Products Regulatory Agency has the power to temporarily authorise products, in cases of urgent public need.
28th Nov 2020 - The Financial Times

GPs step up in 2020 to tackle Covid-19

After the toughest year ever for general practice, Nicola Merrifield reflects on how GPs have stood up to be counted. This year’s battle with Covid-19, has meant GPs have had to be more dedicated and adaptable than ever. They have taken on new ways of remote working and run outdoor or socially distanced clinics, often with smaller teams due to staff self-isolating. There has also been a monumental effort to maintain normal services as far as possible, at a time when GP numbers continue to fall – down by 1.2% on last year, with 334 fewer full-time-equivalent GPs in England, according to the latest official NHS data from September.
28th Nov 2020 - Pulse

SAGE says UK coronavirus cases may double in Christmas lockdown ease

SPI-M-O group warned of massive surges in infections as a result of Christmas This would be because people will mix with those they would not normally see Britons will be able to meet with others from up to three different households
28th Nov 2020 - Daily Mail

Why Oxford's Covid-19 vaccine could do more for the world than other shots

In the days since Oxford University and AstraZeneca unveiled the results of the partnership's Phase 3 Covid-19 vaccine trials, a growing number of questions have emerged. The stated 70% average efficacy was significantly lower than the 94.5% to 95% reported by the other two leading candidates, Moderna and Pfizer. Yet this vaccine could still prove to be more valuable for the world than the other two in the coming months. If the questions over its results are answered and it receives approval, it may lead the way in providing vaccine coverage in poorer countries where it is urgently needed.
28th Nov 2020 - CNN

Covid 19: Redcar rapid testing rolled out amid mass testing talks

Rapid Covid tests will be introduced in an area previously dropped from the mass testing programme. Redcar Council has received 10,000 lateral flow tests, which are able to produce results in under half an hour. A pilot to offer tests to Redcar's 36,000 residents did not go ahead and now the authority is in talks over the cost of reintroducing it. Councillor Steve Kay said the 10,000 rapid tests would help protect the "most vulnerable". All councils in the Tees Valley have been offered the opportunity for residents to take part in mass testing.
28th Nov 2020 - BBC

Covid-19: Mass testing a 'distraction' from vaccine rollout - health leaders

Mass testing plans in England threaten to be a "distraction" from other priorities such as the rollout of a vaccine, health leaders have warned. The PM has said mass community testing, as seen in Liverpool, will be offered to all areas in tier three after lockdown ends. But experts have questioned whether this is possible due to the "enormous" resources it requires. The government said it will work with local authorities to support plans. In a joint statement, the Faculty of Public Health and the Association of Directors of Public Health said improving NHS Test and Trace must remain the top focus for testing.
28th Nov 2020 - BBC

Covid vaccine trials did NOT monitor whether participants took other steps to prevent infection like wearing masks and social distancing

A participant in Pfizer's coronavirus vaccine trials told Business Insider that the firm did not monitor the participants behavior if they didn't feel sick. Moderna also did not specify how to behave or track data on the participants' actions during its trial It was left up to individuals to wear masks or socially distance - behaviors that are estimated to reduce the risk of spreading or catching COVID-19.
27th Nov 2020 - Daily Mail

Europe coronavirus: Second wave began in Spain before spreading via tourists, study suggests

Europe was hit hard by a coronavirus second wave that saw cases rise faster than on any other continent. Scientists have identified a new viral strain they believe is to blame for much of the wave, which first emerged among fruit pickers in northern Spain before being passed to tourists as borders reopened. Tourists took the new strain home, where it spread like wildfire among local communites as rules were relaxed. Strain now accounts for up to 70 per cent of cases in Switzerland, Ireland, and the UK, and is 'prevalent' in Norway, Latvia, the Netherlands, and France
27th Nov 2020 - Daily Mail

Suspected North Korean hackers targeted COVID vaccine maker AstraZeneca - sources

Suspected North Korean hackers have tried to break into the systems of British drugmaker AstraZeneca in recent weeks, two people with knowledge of the matter told Reuters, as the company races to deploy its vaccine for the COVID-19 virus. The hackers posed as recruiters on networking site LinkedIn and WhatsApp to approach AstraZeneca staff with fake job offers, the sources said. They then sent documents purporting to be job descriptions that were laced with malicious code designed to gain access to a victim’s computer. The hacking attempts targeted a “broad set of people” including staff working on COVID-19 research, said one of the sources, but are not thought to have been successful.
27th Nov 2020 - Reuters UK

Why Covid-19 patients with diabetes or heart disease are more likely to die

Researchers studied the role of cholesterol in coronavirus infection. Found the presence of high cholesterol is linked to increased infection of cells. Believed the coronavirus binds to cholesterol and hijacks a lift to the cell surface Once here it can then easily attach to ACE2, the receptor which allows the virus into human cells
27th Nov 2020 - Daily Mail

More than 1,300 wrongly told they have Covid after Test and Trace lab error

More than 1,300 people were wrongly told they had coronavirus due to a lab error with the government’s Test and Trace service. The Department of Health and Social Care (DHSC) said 1,311 people who took a test from 19-23 November across the UK were incorrectly told they received a positive result. It said there was an issue with a batch of testing chemicals which meant their results were void. A DHSC spokesman said: “Swift action is being taken to notify those affected and they are being asked to take another test, and to continue to self-isolate if they have symptoms. This laboratory error was an isolated incident and is being fully investigated to ensure this does not happen again.” The DHSC did not comment on whether the error affected regionalinfection rate figures.
27th Nov 2020 - The Guardian

Chief Medical Officer dodges giving AstraZeneca jab his full backing as the company reveals it will run a NEW Oxford vaccine trial because NO ONE who got accidental low dose that had 90% success rate was aged over 55

Chris Whitty refused to back the injection when asked about controversial data Vaccine scrutinised after it was found to be 70 per cent effective on average But it is but 90% effective with low-dose jab followed by standard booster jab This higher result, based on a sub-group of 2,700 people, was met with concern It came when it emerged that no one in the group was reportedly aged over 55
26th Nov 2020 - Daily Mail

Type O blood linked to lower COVID risk, taking Vitamin D unlikely to help

The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.
27th Nov 2020 - Reuters UK

WHO warns countries with falling COVID cases to stay alert

Even if countries see a fall in coronavirus cases, they need to stay vigilant, Maria Van Kerkhove, the World Health Organization’s technical lead for COVID-19, said on Friday. “What we don’t want to see is situations where you are moving from lockdown to bringing (the virus) under control to another lockdown,” she told a virtual briefing in Geneva. Nearly 61 million people have been reported to be infected by the coronavirus globally and 1.4 million have died, according to a Reuters tally. “It is in our power to keep transmission low,” she said. “We have seen dozens of countries show us that it can be brought under control and kept under control.”
27th Nov 2020 - Reuters

Does the AstraZeneca Vaccine Also Stop Covid Transmission?

Vaccines can prevent symptoms, but some can also keep people from spreading infection. That’s critical, and no one knows if the new vaccines do it.
25th Nov 2020 - WIRED


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Nov 2020

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Covaxx inks supply deals worth $2.8B in lead-up to coronavirus vaccine midstage trials

While some of the leading players in the race for a COVID-19 vaccine are racing toward the finish line, a range of smaller challengers is still hoping to carve out a market niche in the coming months. One of those, New York's Covaxx, is rolling out its first swath of supply deals—and touting its shot's logistics advantage. Covaxx has inked a trio of deals with three South American nations to provide up to 140 million doses of its COVID-19 vaccine at a price tag of $2.8 billion as the drugmaker prepares to enter phase 2/3 testing later this year. Brazil, Ecuador and Peru have all signed on to receive Covaxx's shot, dubbed UB-612, pending regulatory approval. Covaxx is ramping up production to produce 100 million doses in the first half of 2021 and then make a massive leap to churn out 1 billion doses by the end of the year.
25th Nov 2020 - FiercePharma

Britain asks regulator to assess Oxford/AstraZeneca COVID-19 vaccine

Britain on Friday asked its medicine regulator to assess Oxford University and AstraZeneca’s COVID-19 vaccine candidate for temporary supply, a step towards beginning a roll-out before the end of the year. AstraZeneca expects 4 million doses to be available in Britain by the end of next month, and health minister Hancock is targeting the roll-out to begin before Christmas. “We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards,” Hancock said in a statement. “This letter is an important step towards deploying a vaccine as quickly as safely possible.”
27th Nov 2020 - Reuters

Volunteers discuss side-effects after receiving Moderna and Pfizer Covid-19 vaccines

Volunteers who received two of the potential coronavirus vaccines in the US have spoken out about the side-effects they experienced following their jabs. This month, Moderna and Pfizer announced their vaccine candidates had been tested to 94.5 per cent and 95 per cent efficacy respectively. Jennifer Haller, who was injected on 16 March with Moderna’s experimental vaccine in Seattle, told WVPI-TV she only experienced mild side-effects as a result. "I had two doses of the vaccine four weeks apart,” she told the broadcaster. “Each time my arm was pretty sore the next day but besides that I personally didn't experience any other side effects." Ms Haller was the first person to receive a shot of Moderna’s candidate at the Kaiser Permanente Washington Health Research Institute as part of the first human trial of a vaccine to prevent the virus.
26th Nov 2020 - The Independent on MSN.com

AstraZeneca CEO says co likely to run new global trial on COVID-19 vaccine - Bloomberg News

AstraZeneca is likely to run an additional global trial to assess the efficacy of its COVID-19 vaccine, its chief executive Pascal Soriot was quoted as saying on Thursday after questions over the results from its late-stage study. Instead of adding the trial arm to an ongoing U.S. process, a new study would be run to evaluate a lower dosage that performed better than a full amount in AstraZeneca's studies, Soriot was quoted as saying in a Bloomberg News report. "Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study," Soriot was quoted as saying.
26th Nov 2020 - Reuters on MSN.com

Africa CDC sees COVID-19 vaccinations in 2nd quarter of 2021

Vaccinations against COVID-19 in Africa might not start until the second quarter of next year, the continent's top public health official said Thursday, adding that it will be “extremely dangerous” if more developed parts of the world vaccinate themselves and then restrict travel to people with proof of a vaccination. The director of the Africa Centers for Disease Control and Prevention, John Nkengasong, told reporters that “I have seen how Africa is neglected when drugs are available” in the past. And he warned that “it’s clear the second wave (of infections) is here on the continent” of 1.3 billion people. Africa last week surpassed 2 million confirmed coronavirus infections.
26th Nov 2020 - ABC

AstraZeneca will likely re-test its COVID-19 vaccine, CEO says after admitting an error in the first trial that led to skewed results

The UK pharmaceutical company AstraZeneca is likely to run a second global trial to assess its COVID-19 vaccine's efficacy, its CEO told Bloomberg News on Thursday. AstraZeneca and the University of Oxford announced Monday that preliminary results indicated their two-dose vaccine could be up to 90% effective at preventing COVID-19. But the team later said an error in the trial left some participants with half-doses instead of full doses. Experts said that error cast doubt on the validity of the efficacy rate and warranted further study.
26th Nov 2020 - Business Insider

Could Covid-19 Cause Your Teeth to Fall Out?

Earlier this month, Farah Khemili popped a wintergreen breath mint in her mouth and noticed a strange sensation: a bottom tooth wiggling against her tongue. Ms. Khemili, 43, of Voorheesville, N.Y., had never lost an adult tooth. She touched the tooth to confirm it was loose, initially thinking the problem might be the mint. The next day, the tooth flew out of her mouth and into her hand. There was neither blood nor pain. Ms. Khemili survived a bout with Covid-19 this spring, and has joined an online support group as she has endured a slew of symptoms experienced by many other “long haulers”: brain fog, muscle aches and nerve pain.
26th Nov 2020 - The New York Times

AstraZeneca manufacturing error clouds vaccine study results

AstraZeneca and Oxford University have acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine. A statement describing the error on Wednesday came days after the company and the university described the shots as "highly effective" and made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected. In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90 per cent effective. In the group that got two full doses, the vaccine appeared to be 62 per cent effective. Combined, the drugmakers said the vaccine appeared to be 70 per cent effective.
26th Nov 2020 - National Herald

Covid-19: African Union in talks with China and Russia over vaccine |

The Africa Centres for Disease Control and Prevention and the African Union announced they have been in talks with China and Russia over the possibility of vaccine partnerships to ensure that Africa is not left behind when vaccines become available. This was disclosed by John Nkengasong, Africa CDC Chief, at the Bloomberg Invest Africa online conference.
26th Nov 2020 - Nairametrics

Coronavirus lockdowns contributing to faster deterioration in dementia patients, research finds

Forced into lockdowns to prevent the spread of coronavirus, families of people with dementia have been left heartbroken that being isolated appears to have contributed to the deterioration of their loved ones. For Verity Jausnik, coronavirus restrictions meant she was unable to spend quality time with her elderly mother, Vivien "Viv" Russell. Ms Russell, 72, has lived with early onset dementia for a decade but an accelerated deterioration of her condition during the lockdown of her aged care home has meant she has lost her ability to remember her family, particularly her grandchildren.
26th Nov 2020 - ABC News

Scientists ask to see evidence behind relaxing UK's Christmas Covid rules

Ministers are facing calls to publish scientific advice on the relaxing of Covid-19 rules over Christmas amid warnings that a single infectious guest could infect a third of those at a household gathering. Under rules revealed by the prime minister on Tuesday, up to three households can form a “bubble” for five days over Christmas. It prompted some scientists to speak out, warning that mixing will inevitably lead to an increase in infections come the new year, leading to deaths. Some said the government should have put greater emphasis on the dangers and potential control measures. Now experts have called for the government to release advice given by the Scientific Advisory Group for Emergencies (Sage).
26th Nov 2020 - The Guardian

Doubts raised over AstraZeneca-Oxford vaccine data

Disquiet is growing over the way that Oxford university and AstraZeneca have handled the early readout from trials of their coronavirus vaccine, which much of the developing world may rely on to emerge from the pandemic. The results were hailed a success for showing an average efficacy of 70 per cent — a figure reached by pooling the results from cohorts on two different dosing regimens. One set of participants received two identical doses a month apart, while the other group received a half-dose, and then a full dose. The efficacy for the first, larger group was 62 per cent. In the second subgroup, it was 90 per cent. It has emerged that administration of the half-dose started with a mistake. It was then given to a smaller number of participants than those who received two full doses, making the discovery of its greater effectiveness look like a lucky break.
26th Nov 2020 - Financial Times

Untested, untraced: how three-quarters of Covid contacts slip through cracks

Statistics show how ‘world-beating’ tracing scheme fails to follow up on Covid-19 cases at every step. It was in May that Boris Johnson promised the UK would have a “world-beating” test-and-trace operation in place within weeks. “Our test-and-trace system is as good as, or better than, any other system anywhere in the world,” he doubled down in July. But nearly half a year after the system was established, thousands of Covid-19 cases still go undetected each week, leaving severe lockdown restrictions as the only option to prevent hospitals across the country from collapsing. The Guardian has analysed the latest figures on the performance of test and trace to show how people at risk of spreading the virus go missing at every step of the process.
26th Nov 2020 - The Guardian

NHS Test and Trace misses 40% of contacts in a week - just above all-time low

The widely criticised NHS Test and Trace system is still failing to reach two in five coronavirus contacts and remains near a record low, new figures show. Of the 347,575 close contacts of someone who has tested positive in the week to November 18, only 60.3% were reached and told to self-isolate. This is down slightly from 60.7% in the previous week, and is also just above the all-time low of 60.1% for the week to October 14. It is well below the 80% target. Positive Covid-19 cases in England fell 9% in the latest week, the first week-on-week drop since the summer. For cases managed by local health protection teams, 99.0% of contacts were reached and asked to self-isolate in the week to November 18.
26th Nov 2020 - Daily Mirror

Antibody testing likely undercounts the number of people who have had COVID-19: More than 25% of infected health care workers had NO signs of it in their blood work 60 days later

CDC researchers found that 6% of more than 3,000 health care workers they tested had antibodies to coronavirus. Within 60 days, when they were retested 28% of the health care workers had antibody levels so low that they could no longer be detected. Researchers warn this suggests that using antibody testing likely undercounts how many people have had COVID-19 and that plasma has a short shelf life
26th Nov 2020 - Daily Mail

Analysis: Questions over AstraZeneca's COVID-19 vaccine data risk delaying approval

Days after grabbing headlines with its COVID-19 “vaccine for the world”, AstraZeneca is facing tricky questions about its success rate that some experts say could hinder its chances of getting speedy U.S. and EU regulatory approval. Several scientists have raised doubts about the robustness of results showing the shot was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose. “All we have to go on is a limited data release,” said Peter Openshaw, a professor of experimental medicine at Imperial College London. “We have to wait for the full data and to see how the regulators view the results,” he said, adding that U.S. and European regulators “might possibly take a different view” from each other.
26th Nov 2020 - Reuters UK

Feds on COVID-19 mRNA vaccine distribution: Pfizer's dry runs predict a 'very doable process'

What will it take to distribute the first 6.4 million doses of Pfizer’s COVID-19 mRNA vaccine, if all goes according to plan and they ship in mid-December? Alex Azar, secretary of health and human services, acknowledged during a press conference Tuesday that the logistics—which include the need for ultra-cold storage—will be far from easy. But Azar and two other top officials running the government’s Operation Warp Speed effort to speed COVID-19 vaccine distribution did their best to boost the public’s confidence. The FDA has scheduled a meeting to review Pfizer’s vaccine on December 10, and if it’s authorized as expected, it could start shipping within 24 hours, Azar said. In addition to speeding the vaccine to healthcare workers, “CVS Health has said they expect to be vaccinating residents of nursing homes, one of the top priority groups, within 48 hours of FDA authorization,” he said.
25th Nov 2020 - FiercePharma

CureVac ties up Wacker to churn out more than 100M doses of mRNA coronavirus vaccine

Riding a wave of interest in mRNA-based vaccines, Germany's CureVac is looking to rapidly drive manufacturing of its own shot candidate. After announcing a plan to bring more partners on board, CureVac has knotted the first of those deals to the tune of 100 million doses. CureVac has tagged German chemical company Wacker to churn out drug substance for its mRNA-based COVID-19 vaccine with the goal of adding 100 million doses per year to the biotech's stockpile, the partners said this week. Wacker will produce those doses at its Amsterdam facility starting in the first half of 2021, the companies said. The firm plans to "ramp up" its manufacturing capacity to meet that demand and is prepared to expand in the future to add more doses.
25th Nov 2020 - FiercePharma

Less than 10% of Americans had COVID by September, study finds

Large-scale seroprevalence studies conducted over the summer show that, through September, less than 1 in 10 of Americans had evidence of previous coronavirus infection, researchers from the Centers for Disease Control and Prevention (CDC) reported yesterday in JAMA Internal Medicine. In the nationwide seroprevalence survey, researchers from the CDC's COVID-19 Response Team tested blood serum samples from people in 50 states, the District of Columbia, and Puerto Rico during four periods from July through September, looking for the presence of detectable antibodies for SARS-CoV-2, (the virus that causes COVID-19.
25th Nov 2020 - CIDRAP

What the biopharma industry is doing to build confidence in Covid-19 vaccines

Over the last few weeks, the United States has surpassed 100,000 Covid-19 cases a day and reached the staggering milestone of 10 million cases. This is both sobering and humbling. While there has been encouraging news about progress in the development of Covid-19 vaccines, making sure that Americans have confidence in these vaccines is crucial to helping bend the curve of infections and getting us back to some semblance of normalcy. According to researchers writing in The Lancet, we will need a majority of Americans to have the confidence to get vaccinated for Covid-19 vaccines to be effective in moving the U.S. toward population-level control of viral spread. As Anthony Fauci has noted, “If you have a vaccine that is highly effective and not enough people get vaccinated, you’re not going to realize the full, important effect of having a vaccine.”
25th Nov 2020 - STAT News

Studies find no COVID benefit for preventive hydroxychloroquine or for convalescent plasma

Two studies published yesterday in the New England Journal of Medicine found that two once-promising but largely discredited COVID-19 treatments —hydroxychloroquine and convalescent plasma—didn't prevent infection or lead to clinical improvement. 'No compelling data' - The first study, an open-label trial led by researchers at Hospital Germans Trias i Pujol in Barcelona, Spain, involved randomly assigning clusters of healthy adults with high-risk, close-contact exposure to a COVID-19 patient to either 800 milligrams (mg) of hydroxychloroquine followed by 6 days of 400-mg doses or usual care.
25th Nov 2020 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Nov 2020

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I'm a medical writer who just got vaccinated against COVID-19, maybe. You can still join the clinical trial.

Earlier this week, the drug company AstraZeneca announced that its vaccine was highly effective against COVID-19. That’s great news for society. We now have three vaccines against the disease that are getting closer to winning approval. It also was good news for me. I think. Maybe. I hope. At some point in my adult life, I developed an obsession with numbers — especially the kind that might reveal the odds of something happening, such as who will win the presidential election. Or whether the Packers should go for it on fourth and three. Or what my chances are of dying of COVID-19.
25th Nov 2020 - USA Today

New Covid-19 Vaccines Stir Hope for the World’s Poor

With three Western vaccines showing promising effectiveness and a coalition of international health agencies gaining traction, there is cautious optimism in the scramble to secure some doses for the world’s poorest countries. Promising trial results inspire optimism in the developing world, which could yet become a reservoir for the virus for years to come if this issue is not addressed
25th Nov 2020 - The Wall Street Journal

Blood tests for Covid-19 could be made 'up to 100,000 times more sensitive' by using nanodiamonds

Exclusive: Pregnancy test-like sticks are currently being trialled for Covid-19. But they, like the widely-used HIV equivalent, use gold nanoparticles. A red line is made to indicate a positive result when gold particles stick to virus. But using glowing nanodiamonds instead of gold particles gives a stronger signal and is also much more sensitive
25th Nov 2020 - Daily Mail

Tier 1 had 'little impact' on Covid-19 transmission, study suggests

Researchers analysed how well the UK Government’s tiers worked in England, before the second national lockdown came into effect. Tier 1 restrictions were largely inadequate and Tier 2 rules were only effective in around half of local authority areas, according to the University of East Anglia study. Tier 3 restrictions seemed to be effective in most areas, the research which has not yet been peer-reviewed found. However, the researchers say the real problem lies with regions not being allocated to the most appropriate tier swiftly enough.
25th Nov 2020 - Aberdeen Evening Express

A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19

The analysis included 2314 healthy contacts of 672 index case patients with Covid-19 who were identified between March 17 and April 28, 2020. A total of 1116 contacts were randomly assigned to receive hydroxychloroquine and 1198 to receive usual care. Results were similar in the hydroxychloroquine and usual-care groups with respect to the incidence of PCR-confirmed, symptomatic Covid-19 (5.7% and 6.2%, respectively; risk ratio, 0.86 [95% confidence interval, 0.52 to 1.42]). In addition, hydroxychloroquine was not associated with a lower incidence of SARS-CoV-2 transmission than usual care (18.7% and 17.8%, respectively). The incidence of adverse events was higher in the hydroxychloroquine group than in the usual-care group (56.1% vs. 5.9%), but no treatment-related serious adverse events were reported.
25th Nov 2020 - nejm.org

After dosing mix-up, latest COVID-19 vaccine success comes with big question mark

Some evidence suggests that slowly escalating the dose of a vaccine more closely mimics a natural viral infection, leading to a more robust immune response. “It’s not really mechanistically pinned down exactly how it works,” Hill says. Because the different dosing schemes likely led to different immune responses, Hill says researchers have a chance to suss out the mechanism by comparing vaccinated participants’ antibody and T cell levels. The 62% efficacy, he says, “is a blessing in disguise.” But Moore says the low-dose prime group resulted in too few cases to be confident in its results. “Was that a real, statistically robust 90%?” he asks.
25th Nov 2020 - Science Magazine

Researchers Say 90% Of Recent Coronavirus Sequences In U.K. Came From Spain

The U.K is on its second lockdown, and scientists say most sequences of new cases are from a coronavirus strain that originated in Spain — which British tourists brought home from summer vacations.
25th Nov 2020 - NPR

Young people's anxiety levels doubled during lockdown: Study

New research adds to a growing body of evidence that young people's anxiety levels doubled during Covid-19 lockdown. The study, published in the British Journal of Psychiatry, revealed that the number of young people with anxiety doubled from 13 per cent to 24 per cent, during the early stages of the Covid-19 pandemic and lockdown.
25th Nov 2020 - The Times of India

Gender-based violence was predictable, and preventable, fallout of lockdown

The National Commission for Women sounded an alarm in early April that domestic violence cases had spiked in just the first week of the Covid-19 lockdown, as had distress calls. This was echoed by the UN Secretary-General who used the term 'shadow pandemic.' Since then, across the world, police, shelters and helplines have confirmed that although the incidence of domestic violence was always higher than we would like to admit, ther was an alarming increase in its frequenct during the panemic.
25th Nov 2020 - The Indian Express

AstraZeneca Faces Difficult Questions About Its Vaccine After Admitting Mistake

Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures have eroded confidence.
25th Nov 2020 - The New York Times

First round of US lockdowns cost about $6million for each death that was avoided, study finds

Study looked at cost of government-ordered shutdowns from March to May. Found that lockdowns saved 29,000 lives at a total cost of $169 billion. Costs included job losses and declines in companies' market value. Study comes as states impose new restrictions and virus surges
25th Nov 2020 - Daily Mail

China stepping up virus testing on imported food packaging

China is stepping up virus inspections on imported food packaging as cooler weather brings new waves of coronavirus infections in several overseas countries, Chinese officials said Wednesday. Packaging is “not exempt” from carrying the virus, deputy director of the National Food Safety Risk Assessment Center Li Ning told reporters. While the coronavirus positivity rate for tests on packages was just 0.48 per 10,000, that proportion is increasing along with the number of tests being conducted, Li said. She said the virus could “to some extent” be passed to humans from packaging, although neither Li or any other official at Wednesday’s news conference mentioned any such confirmed cases.
25th Nov 2020 - The Associated Press

How Iceland hammered COVID with science

Driving along Reykjavik’s windswept roads on a cold March morning, Kári Stefánsson turned up the radio. The World Health Organization had just announced that an estimated 3.4% of people infected with SARS-CoV-2 would die — a shockingly high fatality rate, some 30 times larger than that for seasonal influenza. There was a problem with that estimate, however: it was based on reported cases of COVID-19, rather than all cases, including mild and asymptomatic infections. “I couldn’t figure out how they could calculate it out without knowing the spread of the virus,” recalls Stefánsson, who is the founder and chief executive of deCODE genetics, a human-genomics company in Reykjavik. He became convinced that making sense of the epidemic, and protecting the people of Iceland from it, would require a sweeping scientific response.
25th Nov 2020 - Nature.com

World scrambles for vaccine deals as COVID infections near 60 million

Countries around the world agonised over new coronavirus curbs ahead of Christmas and other holidays as global infections approached 60 million on Wednesday and U.S. officials pleaded with Americans to stay home over Thanksgiving. The holiday weekend is expected to fuel a surge of infections in the United States, which leads the world with soaring COVID-19 infections and the daily toll on Tuesday climbing above 2,000, the highest 24-hour tally since early May. “All the Thanksgiving travel ensures no one will catch us, either,” said Dr. Tatiana Prowell of the Johns Hopkins School of Medicine. “The U.S. ‘each person for himself’ mindset is killing hundreds of thousands of us. Devastating to watch,” Prowell said on Twitter.
25th Nov 2020 - Reuters UK

Sinopharm applies for approval from China to launch vaccine: state media

Chinese pharmaceutical giant files for regulatory approval, according to Xinhua Finance. China National Biotec Group executive says data review is not complete but Sinopharm chairman says vaccines are protective and safe
25th Nov 2020 - South China Morning Post


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Nov 2020

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How viruses like Covid trick us into spending more time socialising

Can viruses such as the one that causes Covid-19 attack our brains and change our behaviour — thereby prolonging an outbreak? That’s the suggestion from U.S. researchers who say that the coronavirus may be manipulating the behaviour of infected people, sometimes even before they show symptoms, so they become more sociable. In fact, such behaviour-changing effects of viruses — so-called behavioural host manipulation — are not new, and have previously been reported for the flu and rabies viruses, among others.
24th Nov 2020 - Daily Mail

Wealth of data to help understand Covid-19 spread 'not being utilised'

The UK is trailing behind other countries in making use of data to better understand the spread and economic impact of the coronavirus, a team of researchers have said. Aggregated and anonymised data from mobile networks on how people move around and payment transaction data already gathered by companies are just some of the ways that could help give a more accurate picture of the pandemic at national and local levels, the Data Readiness: Lessons from an Emergency report suggests.
24th Nov 2020 - Aberdeen Evening Express

Russia says its Sputnik V Covid-19 vaccine is up to 95% effective

A coronavirus vaccine developed by Russia is up to 95% effective at stopping people developing Covid-19 symptoms, according to its developers. Second interim data from the Sputnik V vaccine appears to provide 91.4% protection 28 days after the first dose and the researchers say the figure is as high as 95% 42 days after the first dose.
24th Nov 2020 - Aberdeen Evening Express

Coronavirus vaccine rollout to start second week of December, CDC director says

CDC Director Dr Robert Redfield said he sees the firsts coronavirus vaccine doses being rolled out the second week of December. HHS officials also announced Tuesday that 6.4 million doses of Pfizer's shot would be released in their first distribution once it gets emergency approval. The FDA's advisory committee will meet to discuss whether to give emergency use authorization to Pfizer's vaccine on December 10. Operation Warp Speed says it is ready to roll a vaccine within 24 hours of its emergency approval. Speaking on Fox's The Daily Briefing, Dr Redfield also said that household gatherings are fueling the latest surge in coronavirus cases. Health and Human Services Secretary also said Tuesday that states will have the 'final say' who should be first priority to get vaccinated.
24th Nov 2020 - Daily Mail

Oxford–AstraZeneca COVID vaccine works — but scientists have questions

Early data indicate that the Oxford–AstraZeneca jab is effective, but dose makes a difference. Plus, the scientific dilemma posed by emergency vaccine approvals, and an AI that sums up papers in a sentence.
24th Nov 2020 - Nature.com

Bill Gates: 'Almost all' coronavirus vaccines will work by February

Bill Gates is feeling optimistic about coronavirus vaccine development. The first two vaccine candidates likely to receive FDA authorization, one from Pfizer and the other from Moderna, appear to be 95 percent effective against the virus. But the Microsoft co-founder and co-founder of the Bill & Melinda Gates Foundation also has high hopes for vaccines that haven't yet made big headlines, including those developed by AstraZeneca, Johnson & Johnson and Novavax. "Almost all the vaccines will work and with very high efficacy levels," Gates told CNN's Fareed Zakaria in an interview on Sunday. "I'm optimistic that by February it's very likely that they'll all prove very efficacious and safe."
24th Nov 2020 - CNET

Politics, Science and the Remarkable Race for a Coronavirus Vaccine

The call was tense, the message discouraging. Moncef Slaoui, the head of the Trump administration’s effort to quickly produce a vaccine for the coronavirus, was on the phone at 6 p.m. on Aug. 25 to tell the upstart biotech firm Moderna that it had to slow the final stage of testing its vaccine in humans. Moderna’s chief executive, Stéphane Bancel, a French biochemical engineer, recognized the implication. In the race to quell the pandemic, he said, “every day mattered.” Now his company, which had yet to bring a single product to market, faced a delay of up to three weeks. Pfizer, the global pharmaceutical giant that was busy testing a similar vaccine candidate and promising initial results by October, would take the obvious lead.
24th Nov 2020 - The New York Times

Plasma from recovered patients shows little benefit in those hospitalized with COVID-19: study

Using blood plasma from COVID-19 survivors to treat patients with severe pneumonia caused by the novel coronavirus showed little benefit, according to data released on Tuesday from a clinical trial in Argentina. The therapy know as convalescent plasma, which delivers antibodies from COVID-19 survivors to infected people, did not significantly improve patients’ health status or reduce their risk of dying from the disease any better than a placebo, the study published in The New England Journal of Medicine found. Despite limited evidence of its efficacy, convalescent plasma, which U.S. President Donald Trump touted in August as a “historic breakthrough,” has been frequently given to patients in the United States.
24th Nov 2020 - Reuters UK

U.S. officials plan to release 6.4 mln COVID-19 vaccine doses in first distribution

U.S. officials said on Tuesday they plan to release 6.4 million COVID-19 vaccine doses nationwide in an initial distribution after the first one is cleared by regulators for emergency use. Officials from the government’s Operation Warp Speed program told reporters that states and other jurisdictions had been informed on Friday of their estimated vaccine allocations in the first shipments so they can begin planning for how to best distribute it to their high-risk populations. The officials had previously said they anticipate 40 million doses will be distributed by year end, a number they reiterated on Tuesday.
24th Nov 2020 - Reuters

COVID vaccination is the government’s ‘national commitment’: Modi

Indian Prime Minister Narendra Modi says providing the coronavirus vaccine is his government’s “national commitment”, and that the safety of all citizens will be assured. “Each State and stakeholder has to work as a team to ensure that this mission is systematic, smooth and a sustained effort,” Modi said during a meeting with state chief ministers on the COVID-19 situation in which he told them national efforts would be in coordination with state governments.
24th Nov 2020 - AlJazeera

AstraZeneca shares fall after efficacy findings for Covid-19 vaccine

AstraZeneca shares fell after the drugmaker announced efficacy results for its Covid-19 vaccine that were below those reported by rivals Pfizer/BioNTech and Moderna. The shares ended the day 3.8% lower at £80. Results from the phase 3 trial showed the vaccine developed with the University of Oxford can protect 70.4% of people from becoming ill and, in a surprise result, up to 90% if a lower first dose is used. This is lower than the 95% efficacy reported for vaccines developed by the US drugmaker Pfizer and the German biotech BioNTech, and the US biotech Moderna. Analysts said the AstraZeneca/Oxford results left some unanswered questions.
23rd Nov 2020 - The Guardian

AstraZeneca COVID vaccine latest to show high efficacy

In interim late-stage study findings, Oxford University today announced that the COVID-19 vaccine it is developing with AstraZeneca is highly effective, bringing the world promising news for the third time this month about a pandemic vaccine candidate. The latest vaccine news comes as COVID-19 levels surge in the United States and Europe, with fears that illness levels could jump again after Thanksgiving and Christmas holiday gatherings.
23rd Nov 2020 - CIDRAP

3rd major COVID-19 vaccine shown to be effective and cheaper

Drugmaker AstraZeneca said Monday that late-stage trials showed its COVID-19 vaccine is highly effective, buoying the prospects of a relatively cheap, easy-to-store product that may become the vaccine of choice for the developing world. The results are based on an interim analysis of trials in the U.K. and Brazil of a vaccine developed by Oxford University and manufactured by AstraZeneca. No hospitalizations or severe cases of COVID-19 were reported in those receiving the vaccine.
23rd Nov 2020 - The Associated Press


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Nov 2020

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New Zealand study details COVID-19 spread on long-haul flight despite tests

A recent case study details COVID-19 transmission on a New Zealand long-haul flight, even with negative pre-departure testing results and social distancing requirements. The 12-page report, released by New Zealand health officials last weekFriday, follows a cluster of coronavirus cases linked to one passenger traveling on an 18-hour flight from Dubai to New Zealand in September. Though the traveler tested negative with a PCR test before the flight, researchers concluded that "at least four in-flight transmission events of SARS-CoV-2 likely took place" as the pre-symptomatic yet contagious person infected at least four others. SARS-CoV-2 is the virus that causes COVID-19.
23rd Nov 2020 - USA Today

AstraZeneca-Oxford Covid-19 Vaccine Up to 90% Effective in Late-Stage Trials

AstraZeneca PLC and the University of Oxford added their vaccine candidate to a growing list of shots showing promising effectiveness against Covid-19—setting in motion disparate regulatory and distribution tracks that executives and researchers hope will result in the start of widespread vaccinations by the end of the year. AstraZeneca and Oxford said their vaccine was as much as 90% effective in preventing the infection without serious side effects in large clinical trials, though they said the vaccine’s efficacy is up to 90% in late stage trials
23rd Nov 2020 - The Wall Street Journal

AstraZeneca: COVID-19 vaccine shown to be 'highly effective'

Drugmaker AstraZeneca said Monday that late-stage trials showed its COVID-19 vaccine is highly effective, buoying the prospects of a relatively cheap, easy-to-store product that may become the vaccine of choice for the developing world. The results are based on an interim analysis of trials in the U.K. and Brazil of a vaccine developed by Oxford University and manufactured by AstraZeneca. No hospitalizations or severe cases of COVID-19 were reported in those receiving the vaccine. AstraZeneca is the third major drug company to report late-stage data for a potential COVID-19 vaccine as the world waits for scientific breakthroughs that will end a pandemic that has pummeled the world economy and led to 1.4 million deaths. But unlike the others, the Oxford-AstraZeneca vaccine doesn’t have to be stored at freezer temperatures, making it potentially easier to distribute, especially in developing countries.
23rd Nov 2020 - ABCNews.go

AstraZeneca says COVID-19 'vaccine for the world' can be 90% effective

AstraZeneca said on Monday its COVID-19 vaccine was 70% effective in pivotal trials and could be up to 90% effective, giving the world’s fight against the global pandemic a third new weapon that can be cheaper to make, easier to distribute and faster to scale-up than rivals.
23rd Nov 2020 - Reuters

Oxford-AstraZeneca COVID-19 vaccine is up to 90% effective

Oxford-AstraZeneca has announced its COVID-19 vaccine is up to 90% effective US already has a deal to purchase 300 million doses for $1.2 billion. The British drugmaker is the third major drug company to report late-stage results for a potential COVID-19 vaccine. Pfizer and Moderna last week reported preliminary results from late-stage trials showing their vaccines were almost 95% effective. Unlike its rivals, however, the AstraZeneca vaccine doesn't have to be stored at ultra-cold temperatures, which makes it easier to distribute
23rd Nov 2020 - Daily Mail

Bill Gates: 'almost all' Covid-19 vaccines will work by February 2021

Bill Gates has been a polarising figure during the coronavirus pandemic, but now the billionaire philanthropist has reason to be hopeful. Speaking to CNN, Gates explained how he felt ‘almost all’ of the coronavirus vaccines in development will be ready by February next year. The first two vaccines expected to be granted FDA approval in the US are the ones developed by Pfizer and Moderna. But Gates says the others in development – from the likes of AstraZeneca, Johnson & Johnson and Novavax – will also be successful. ‘Almost all the vaccines will work and with very high efficacy levels,’ Gates told CNN’s Fareed Zakaria.
23rd Nov 2020 - Metro.co.uk

Covid-19 pandemic: Merkel 'worried' about vaccines for poor countries

Germany's chancellor has raised concerns about the world's poorest securing access to Covid-19 vaccines. Angela Merkel was speaking at a G20 summit which saw leaders promise a fair distribution of jabs. But Mrs Merkel warned progress was slow, saying she would raise the matter with global vaccine alliance GAVI. "We will now speak with GAVI about when these negotiations will begin because I am somewhat worried that nothing has been done on that yet," she said.
23rd Nov 2020 - BBC

Covid-19: Daily coronavirus test plan to cut contacts' 14-day self-isolation

Daily coronavirus tests will be offered to close contacts of people who have tested positive in England, as a way to reduce the current 14-day quarantine. Prime Minister Boris Johnson said people will be offered tests every day for a week - and they will not need to isolate unless they test positive. He also said rapid tests will allow every care home resident to have up to two visitors tested twice a week. Labour welcomed increased testing but raised concerns over test-and-trace. The chairman of the Independent Care Group which represents independent care homes, Mike Padgham, said the government was being "rather ambitious".
23rd Nov 2020 - BBC

AstraZeneca says COVID-19 'vaccine for the world' can be 90% effective

AstraZeneca said on Monday its COVID-19 vaccine was 70% effective in pivotal trials and could be up to 90% effective, giving the world’s fight against the global pandemic a third new weapon that can be cheaper to make, easier to distribute and faster to scale-up than rivals.
23rd Nov 2020 - Reuters UK

Decades of work, and half a dose of fortune, drove Oxford vaccine success

It took Oxford University’s brightest minds decades of work to give them the expertise to develop a COVID-19 vaccine. In the end, it was a momentary error - and a dose of good fortune - that carried them over the line. The Oxford vaccinologists were exhilarated on Monday when drugmaker AstraZeneca, with whom they developed the shot, announced that it could be around 90% effective, citing data from late-stage trials. “It can only happen if extraordinary support is provided,” Adrian Hill, director of Oxford University’s Jenner Institute which developed the shot, told Reuters. “We had pretty well the whole institute in Oxford working on this vaccine.” While skill and hard work drove development, AstraZeneca said it was a minor mistake that made the team realise how they could significantly boost the shot’s success rate, to as much as 90% from around 60%: by administering a half dose, followed by a full dose a month later. The Oxford vaccinologists were exhilarated on Monday when drugmaker AstraZeneca, with whom they developed the shot, announced that it could be around 90% effective, citing data from late-stage trials. “It can only happen if extraordinary support is provided,” Adrian Hill, director of Oxford University’s Jenner Institute which developed the shot, told Reuters. “We had pretty well the whole institute in Oxford working on this vaccine.”
23rd Nov 2020 - Reuters UK

Health experts in B.C. divided over merits of severe Australian-style lockdown

Former Vancouverite Graham Barron can really appreciate what freedom feels like. Barron lives in Melbourne, Australia, with his wife and two young children. For nearly three months beginning in August, they endured one of the world's most severe lockdowns. "It was really hard," Barron said. "It was difficult to be at home all the time." Overnight curfews were put in place. Residents could only leave home for an hour at a time, and only within five kilometres. Masks had to be worn everywhere.
22nd Nov 2020 - CBC.ca

COVID-19 vaccines: How do the Moderna, Pfizer and Oxford coronavirus jab candidates compare?

Three trials of vaccines that will be available to the UK have all reported they are around 90% effective in late stage trials. The University of Oxford/AstraZeneca vaccine announced its phase three results on 23 November. It was the final of the three, with Pfizer/BioNTech the first to announce its results, followed a week later by Moderna, but that vaccine is still in trials.
20th Nov 2020 - Sky News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Nov 2020

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In Dr. Fauci's words: Why Americans shouldn't fear a COVID-19 vaccine authorized by the FDA

Public confidence in the vaccine approval process is key to beating the pandemic, Dr. Anthony Fauci emphasized to the USA TODAY Editorial Board.
22nd Nov 2020 - USA Today

Regeneron's COVID-19 antibody treatment given to Trump is given emergency clearance by the FDA

The experimental drug was given to Trump during his stay in Walter Reed FDA said the cocktail should be given to treat mild to moderate COVID cases Regeneron said the drug has the greatest benefit early on in treatment
22nd Nov 2020 - Daily Mail

Experimental drug given to Trump to treat covid-19 wins FDA clearance

The Food and Drug Administration on Saturday granted emergency authorization to the experimental antibody treatment given to President Trump last month when he developed covid-19, the disease caused by the novel coronavirus. The drug, made by Regeneron Pharmaceuticals, is designed to prevent infected people from developing severe illness. Instead of waiting for the body to develop its own protective immune response, the drug imitates the body’s natural defenses. It is the second drug of this type — called a monoclonal antibody — to be cleared for treating covid-19. The FDA authorized Eli Lilly & Co.’s drug on Nov. 9.
22nd Nov 2020 - The Washington Post

A Look At COVID-19 Vaccine Development Progress

The race to develop COVID-19 vaccines is moving swiftly, both nationally and internationally. But challenges remain when it comes to distributing vaccines around the world. This week, the nation passed the milestone of 250,000 deaths from COVID-19 - a quarter of a million lives lost to a pandemic that continues to rage from coast to coast across the country. But even amid the warnings of a dark winter ahead and the CDC strongly recommending that Americans stay home for Thanksgiving next week, there is hope.
22nd Nov 2020 - NPR

Why the race to find Covid-19 vaccines is far from over

While everyone celebrated this month’s news that not one but two experimental vaccines against Covid-19 have proved at least 90% effective at preventing disease in late-stage clinical trials, research into understanding how the Sars-CoV-2 virus, which causes Covid-19, interacts with the human immune system never paused. There are plenty of questions still to answer about the Pfizer/BioNTech and Moderna vaccines: how well will they protect the elderly, for example, and how long for? Which aspects of the immune response that they elicit are protective and which aren’t? Can even better results be achieved, with vaccines that target different parts of the immune system?
22nd Nov 2020 - The Guardian

Remdesivir: don't use drug Trump took for Covid-19, WHO says

Remdesivir, one of the drugs Donald Trump took when he developed Covid-19, should not be used in hospitals because there is no evidence it works, the World Health Organization has advised. The US president was an enthusiastic proponent of the drug, to the point where he boasted in July that he had bought up the world’s entire stock for Americans. The WHO’s guidelines committee, however, has said Covid patients may be better off without it. The WHO issued what it calls a “living guideline”, which can be updated as evidence comes in, largely as a result of a Solidarity trial it led in several countries. Solidarity allocated patients randomly to several drugs including remdesivir and found that those who took it were no more likely to survive severe Covid than those who did not.
21st Nov 2020 - The Guardian

Trials For AstraZeneca's Covid-19 Treatment Set To Begin In UK

The UK will be the first country to begin clinical trials of a new coronavirus antibody treatment developed by drugs giant AstraZeneca aimed at people with a weakened immune system who cannot be vaccinated. A participant in Wakefield, West Yorkshire, will be the first in the world to receive the pharmaceutical company’s new “antibody cocktail” as part of the trial to test whether it will prevent Covid-19 for up to year. The clinical trial programme will recruit 5,000 participants, which includes 1,000 people from nine sites in the UK. The aim of the trial is to evaluate the safety and effectiveness of a combination of two long-acting monoclonal antibodies – man-made proteins that act like natural human antibodies in the immune system.
21st Nov 2020 - ITV News

Covid-19 carriers 'most infectious earlier on'

People are most likely to pass on coronavirus within the first five days of having symptoms, an extensive study suggests. The research indicates patients had the highest levels of virus early on in their illness and "live" virus, capable of replicating, was found up to nine days after symptoms began. UK scientists say their study emphasises early isolation is critical to stopping spread. The work appears in the Lancet Microbe.
21st Nov 2020 - BBC

Covid-19: Alternative jab trialled and antibodies 'last at least six months'

1. Jab for people who cannot be vaccinated trialled - For those without functioning immune systems, a possible alternative to a vaccine is entering its final stage of trials. It is hoped the jab could provide at least six months' protection for those unable to receive vaccines.
21st Nov 2020 - BBC

GPs will not deliver bulk of Covid-19 vaccines given this year, says Hancock

GPs will not be required to deliver the majority of Covid-19 vaccinations that are administered this year, the health secretary has confirmed. In today’s Downing Street press briefing Matt Hancock said mass vaccination centres would deliver the bulk of the programme next month – and GPs would take a more prominent role in 2021. The health secretary also confirmed the MHRA has been asked to assess the Pfizer vaccine, representing the final step before the vaccination programme can begin. Deputy chief medical officer Professor Jonathan Van-Tam said at the briefing that the speed of rollout depended on manufacturing and regulatory constraints. He said: ‘It’s in the hands of the manufacturers and the regulatory agencies around how quickly batches can be released for use if they are authorised.’
21st Nov 2020 - Pulse

Moderna's Covid vaccine offers vindication of its unconventional approach

When Stéphane Bancel took the top job at Moderna 10 years ago, he warned his wife the business had only a 5 per cent chance of success. The Boston-based biotech was trying to invent a new generation of medicines based on an unproved genetic engineering technique and, instead of investing in drugs one by one, was aiming to raise record amounts of money to build a platform that would work to develop the entire class of new products. Thanks to the biggest public health crisis in a generation, it now looks likely that Moderna will win approval for the first product created by this approach three or four years ahead of schedule, after early data published this week showed its Covid-19 vaccine to be almost 95 per cent effective.
21st Nov 2020 - Financial Times

Pfizer applies for emergency vaccine approval as U.S. cases reach new high

Pfizer and its German partner BioNTech on Friday became the first companies to seek emergency authorization for a coronavirus vaccine in the United States, a landmark moment and a signal that a powerful tool to help control the pandemic could begin to be available by late December. Conditions around the country remain dire: The United States reported a record high of more than 196,000 new coronavirus cases on Friday and is likely to cross 12 million cases nationwide on Saturday, six days after surpassing 11 million.
21st Nov 2020 - The Washington Post

Wealthy nations urged to give portion of Covid vaccine as 'humanitarian buffer'

Public health groups are lobbying countries to commit a portion of their Covid-19 vaccine supplies to a “humanitarian buffer” that would be used to inoculate people living in rebel-held territories, those in asylum-seeker camps and others unlikely to receive vaccinations from their governments. The emergency stockpile is intended to act as a safety net to ensure the global effort to end the Covid-19 pandemic is not sabotaged by governments using vaccines as bargaining chip with restive populations, or simply denying it to some marginalised groups. “In Syria there are a lot of internally displaced people who might end up in areas not controlled by the government, or they might be considered to be anti-government or pro-revolution,” said Alain Alsalhani, a vaccine pharmacist who works with Médecins Sans Frontières.
21st Nov 2020 - The Guardian

Pfizer, BioNTech submit emergency authorization request to FDA Friday for COVID-19 vaccine

Pfizer and partner BioNTech announced they have submitted a request on Friday to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate. "It is with great pride and joy, and even a little relief, but I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA's hands," Dr. Albert Bourla, chairman and CEO of Pfizer, said in a video statement Friday afternoon. "This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day."
20th Nov 2020 - ABCNews.go.com

People with coronavirus ‘most likely to be highly infectious in first week after showing symptoms’

People infected with coronavirus are most likely to be highly infectious in the first week after symptoms appear, research has found. Genetic material of Sars-CoV-2, the virus that causes Covid-19, may still be detected in respiratory or stool samples for several weeks after infection. However, no live virus was found in any type of sample collected beyond nine days of symptoms starting, the study found. Researchers said people with the virus are mostly likely to be highly infectious for five days after symptom onset. The review published in The Lancet Microbe suggested people infected with Sars-CoV-2 are most likely to be highly infectious in the first week after symptom onset.
20th Nov 2020 - Evening Standard

Almost a million people have been given an experimental Chinese coronavirus vaccine, pharmaceutical giant claims

Almost a million people have been given an experimental coronavirus vaccine developed by Sinopharm as part of an emergency-use program authorized by Beijing, the Chinese pharmaceutical giant's chairman said. No serious adverse effects have been reported from vaccine recipients so far, Sinopharm said Wednesday in an article on social media platform WeChat, citing Chairman Liu Jingzhen. "In emergency use, we now have used it on nearly a million people. We have not received any reports of serious adverse reaction, and only a few have some mild symptoms," Liu said.
20th Nov 2020 - CNN

COVID-19: Pfizer requests emergency authorisation for coronavirus vaccine in US

Pfizer and BioNTech are submitting an emergency authorisation request in the US which could allow its coronavirus vaccine to be used to treat high-risk populations in the country by mid-December. The UK has already ordered enough of the vaccine to treat 20 million people but it has not yet been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).
20th Nov 2020 - Sky News

Covid: Jab for people who cannot be vaccinated trialled

A possible alternative to a vaccine, for people without functioning immune systems, is entering its final stage of trials. The injection was developed using antibodies - made by the immune system to fight infection - produced by a single Covid patient in the US. It is hoped it could provide at least six months' protection for patients who cannot receive vaccines. Trials involving 1,000 UK participants begin in Manchester on Saturday. A further 4,000 people are involved in the trial globally, which is being organised by pharmaceutical giant AstraZeneca. Participants will be given either an injection containing two different Covid-19 antibodies, which have been specially engineered to last longer in the body - or a placebo.
20th Nov 2020 - BBC

Scientists race to find 'warm' Covid vaccine to solve issue of cold storage

News that one of the potential coronavirus vaccines had at least a 90% efficacy rate was a “victory for science”, said K Srinath Reddy, a cardiologist and president of the Public Health Foundation of India. But it meant little to his country’s 1.3 billion citizens. “For us, the Pfizer vaccine is more of a scientific curiosity than a practical possibility,” Reddy said. The need to store the Pfizer/BioNTech vaccine at at least -70C(-94F), with its required cold-chain infrastructure, puts it out of the reach of up to two-thirds of the world’s population, including swathes of south Asia, Africa and even rural parts of the US and South America, according to German logistics company DHL.
20th Nov 2020 - The Guardian

EU regulator ‘hopeful’ about coronavirus vaccine approval by year-end

Amid rising cases and second-wave lockdowns, Europe might have a coronavirus vaccine authorized to use before the end of 2020. Speaking during POLITICO’s Health Care Summit Wednesday, the head of the European Medicines Agency (EMA), Emer Cooke, said she’s “hopeful” that the agency will have an opinion about whether to authorize a coronavirus vaccine made by Pfizer and BioNTech by the end of the year. Cooke’s comments followed breaking news that the companies found their vaccine to be 95 percent effective after completing a full review of their ongoing large-scale Phase 3 clinical trial.
20th Nov 2020 - POLITICO.eu

Covid-19: A 'step forward' in vaccine roll-out plans and infections levelling off

The UK government has formally asked the Medicines and Healthcare products Regulatory Agency to assess the Pfizer-BioNTech vaccine, one of the frontrunners in the race for a coronavirus cure. Health Secretary Matt Hancock said it was "another important step forward" and that, if approved, it would be available across the NHS for free across all of the UK. He said the UK has contributed more than any other country towards researching a vaccine, something he said the country should be proud of. It follows Pfizer and BioNTech seeking emergency authorisation for the vaccine in the US.
20th Nov 2020 - BBC

Health staff, care homes and over 80s to get Covid vaccine first

Frontline health workers, care home residents and staff and over 80s will be first to get a coronavirus vaccine in Scotland. Next in line will be over 65s and younger people with underlying health conditions likely to badly affected by the virus. More than one million people in Scotland could be vaccinated by the end of January, the health secretary Jeane Freeman told parliament on Thursday. Everyone aged over 18 – around 4.4m people – will eventually be offered the protection from Covid-19, with rollout possibly starting from the first week of December if a vaccine is approved by then.
20th Nov 2020 - STV News

NHS worker first volunteer in stage-three coronavirus vaccine trial

An NHS worker has become the very first person to be recruited for the final stage of a coronavirus vaccine trial. Claire Cole is the first person in the world to give consent to participate in phase-three of a trial to test the safety and efficacy of a coronavirus vaccine developed by Janssen Pharmaceutical Companies of Johnson & Johnson. Cole, head of research delivery at Manchester University, is one of 6,000 volunteers in the UK and 30,000 worldwide who are being recruited for the study, which will take place at 17 National Institute for Health Research sites in the UK, including one in Manchester.
20th Nov 2020 - The Independent

Covid-19 news: NHS drafts plan to vaccinate adults in England by April

A draft of NHS England’s plan for the roll-out of a coronavirus vaccine aims for widespread vaccination of all willing adults in England by early April, if sufficient doses and other crucial supplies are available. Under NHS England’s draft covid-19 vaccine deployment programme, which was outlined in a leaked document dated 13 November seen by HSJ, most doses of the potential vaccine would be administered between early January and mid-March, at a rate of between 4 and 5 million each week.
20th Nov 2020 - New Scientist

Is Inovio Back in the Coronavirus Vaccine Race?

Inovio Pharmaceuticals investors can breathe a little easier this week after the U.S. Food and Drug Administration lifted a partial clinical hold on the planned phase 2 study of the company's investigational coronavirus vaccine. The biotech can now move forward with that part of the trial. Adding to the good news, Inovio said the U.S. Department of Defense will fund the phase 2 and phase 3 trials. Inovio shares, down 34% since the announcement of the partial hold in late September, jumped nearly 15% in one trading session. So does this mean Inovio is back as one of the main players in the coronavirus race? Well, it's clear the hold set the company behind from a timeline perspective. But rapidity isn't everything in this race. Let's take a closer look at where Inovio stands right now.
20th Nov 2020 - Motley Fool

A Global Covid Vaccine Heist

Breakthroughs on vaccines and new treatments are finally offering the world a path to end the Covid-19 pandemic. They’re a tribute to private U.S. corporate innovation, but now developing countries led by India and South Africa are making a damaging bid to waive patent protections for these life-saving advances. The attempt will surface Friday when these countries offer a resolution at the World Trade Organization meeting to waive patent protections for Covid vaccines, therapies and other technologies. They say this is needed to ensure poor countries have equal access, but their effort would harm everyone, including the poor.
20th Nov 2020 - The Wall Street Journal

First batch of coronavirus vaccine ready in Australia by New Year's Day

The AstraZeneca vaccine, which is being produced by biotechnology giant CSL, is on track to be ready by December 28 but will need to be tested in various clinical trials.
20th Nov 2020 - Daily Mail on MSN.com

MMR jab could help protect people from coronavirus until a vaccine is ready, study finds

The MMR jab could be used to slow the spread of Covid-19 while Britons are gradually inoculated with vaccines being developed for the virus, a study suggests. Researchers have found that people who had had the measles-mumps-rubella vaccine as a child suffered far less severe symptoms of Covid – in many cases having mild symptoms or not symptoms at all. “The study found a statistically significant inverse relationship between the level of mumps antibodies and Covid-19. This indicates that there is a relationship that warrants further investigation,” said Professor David Hurley, of the University of Georgia. “If it has the ultimate benefit of preventing infection from Covid-19, preventing the spread of Covid-19, reducing the severity of it, or a combination of any or all of those, it is a very high reward low risk ratio intervention. It would be prudent to vaccinate [people of all ages],” he said.
20th Nov 2020 - iNews

Lockdowns could be avoided if 95% of people wore masks, says WHO

Lockdowns could be avoided if everyone followed health measures such as wearing masks, the World Health Organization's top Europe official said at a Thursday news briefing. WHO Europe's Regional Director Hans Kluge stressed that lockdowns should be a "last resort," and urged the public to follow guidance to help to prevent deaths. He said that if 95% of people wore masks, instead of the current 60%, "lockdowns would not be needed" -- although he added that mask use was not a "panacea" and needed to be combined with other measures. "If we all do our share, lockdowns are avoidable," Kluge said.
19th Nov 2020 - CNN

A nasal spray that can protect against Covid-19 is now ‘ready for use in humans

A nasal spray that can provide effective protection against Covid-19 is now ready for use in humans, according to researchers. The spray has been developed by scientists at the University of Birmingham and is formulated using compounds already widely approved by regulatory bodies in the UK, Europe and the US.
19th Nov 2020 - The Scotsman

Oxford vaccine produces strong response in older adults, early data reveals

Hopes have been raised that the UK could produce a successful coronavirus vaccine after data from the University of Oxford showed its jab provokes a strong immune response in older people. The ChAdOx1 nCov-2019 vaccine, developed with pharmaceutical giant AstraZeneca, has been shown to trigger a robust immune response in healthy adults aged 56-69 and people over 70. Phase two data, published in The Lancet, suggests one of the groups most vulnerable to serious illness and death from Covid-19 could build immunity, researchers say.
19th Nov 2020 - The National

Childhood vaccine linked to less severe COVID-19, cigarette smoke raises risk

The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.
19th Nov 2020 - Reuters

One in three elderly Covid-19 patients are delirious, study finds

817 Covid-19 patients over the age of 65 in hospital were in the study Had an average age of 78 and 226 (28 per cent) were diagnosed as delirius 84 (37 per cent) did not have any typical Covid-19 symptoms
19th Nov 2020 - Daily Mail


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Nov 2020

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Oxford COVID-19 trial will look at interim Phase III data after 53 infections: investigator

Oxford University will start an initial analysis of data from its late-stage trial of the experimental COVID-19 vaccine it is developing with AstraZeneca after 53 infections among its volunteers, the study’s chief investigator said on Thursday. The Oxford Vaccine Group’s director, Andrew Pollard, said in a media briefing there were “lots of cases” of infections in its Phase III trial in Britain, Brazil and South Africa. The first two sets of interim data from vaccine trials from Pfizer and BioNTech last week and Moderna on Monday were released after more than 90 infections among volunteers. Pfizer had planned to publish initial data after about 60 infections, but it exceeded its target after the big jump in infections recently in the United States.
19th Nov 2020 - Reuters

A gym trainer exposed 50 athletes to Covid-19, but no one else got sick because of a ventilation redesign

A Virginia gym owner thought she had a nightmare scenario on her hands when she learned that 50 athletes were potentially exposed to Covid-19 particles by one of the gym's coaches. But not a single member ended up contracting the virus, thanks to the extra safety precautions and ventilation measures she put in place. Velvet Minnick, 44, is the owner and head coach at 460 Fitness in Blacksburg, Virginia. Like many gym owners across the nation, she was forced to shut down the facility in March due to coronavirus. They rented out equipment and held Zoom classes, but it wasn't long before members were burned out. As the state entered Phase 2 of reopening in June, Minnick was allowed to have athletes back inside her facility. She knew one member, however, who could help her get people back while keeping them safe.
19th Nov 2020 - CNN

The known unknowns of T cell immunity to COVID-19

The broad clinical spectrum of COVID-19 indicates widespread intraindividual differences in the host immune defense against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The underlying cause of disease heterogeneity is probably multifactorial. However, a rapid early host response is likely critical to generate control of SARS-CoV-2 viremia before spread to the lower respiratory tract and onset of damaging hyperinflammation. In this regard, the literature is full of examples where functional T cell responses can provide early control of acute viral infections, including SARS-CoV and MERS-CoV (1, 2). Although multiple studies have indicated that T cells play a role in the early immune response to SARS-CoV-2 and can generate a functional memory pool, there are still multiple unanswered questions in the field (Box 1). Here, we summarize and speculate on a specific set of questions related to T cell immunity against respiratory viral infections, with a focus on COVID-19 severity, immunity, long-term consequences, and vaccination
19th Nov 2020 - Science

Covid-19 mink variants discovered in humans in seven countries

Seven countries are now reporting mink-related Sars-CoV-2 mutations in humans, according to new scientific analysis. The mutations are identified as Covid-19 mink variants as they have repeatedly been found in mink and now in humans as well. Uncertainty around the implications of the discovery of a Covid-19 mink variant in humans led Denmark, the world’s largest mink fur producer, to launch a nationwide cull earlier this month. The cull was sparked by research from Denmark’s public health body, the Statens Serum Institut (SSI), which showed that a mink variant called C5 was harder for antibodies to neutralise and posed a potential threat to vaccine efficacy.
19th Nov 2020 - The Guardian

Covid: Oxford vaccine shows 'encouraging' immune response in older adults

The Oxford coronavirus vaccine shows a strong immune response in adults in their 60s and 70s, raising hopes that it can protect age groups most at risk from the virus. Researchers say the Lancet phase two findings, based on 560 healthy adult volunteers, are "encouraging". They are also testing whether the vaccine stops people developing Covid-19 in larger, phase three trials. Early results from this crucial stage are expected in the coming weeks. Three vaccines - Pfizer-BioNTech, Sputnik and Moderna - have already reported good preliminary data from phase three trials, with one suggesting 94% of over-65s could be protected from Covid-19.
19th Nov 2020 - BBC

Anti-COVID-19 nasal spray 'ready for use in humans'

A nasal spray that can provide effective protection against the COVID-19 virus has been developed by researchers at the University of Birmingham, using materials already cleared for use in humans. A team in the University’s Healthcare Technologies Institute formulated the spray using compounds already widely approved by regulatory bodies in the UK, Europe and the US. The materials are already widely used in medical devices, medicines and even food products.
19th Nov 2020 - University of Birmingham

Arthritis drug effective in treating sickest COVID-19 patients | Imperial News

Critically ill COVID-19 patients treated with an arthritis drug are significantly more likely to have improved outcomes, a study has found. The early findings, which are yet to be published, come from the REMAP-CAP trial, led by Imperial College London and the Intensive Care National Audit & Research Centre (ICNARC) in the UK and Utrecht University in Europe. The trial evaluates the effect of treatments on a combination of survival and length of time patients need support in an intensive care unit (ICU).
19th Nov 2020 - Imperial College London

Lockdowns could be avoided if 95% of people wore masks, says WHO

Lockdowns could be avoided if everyone followed health measures such as wearing masks, the World Health Organization's top Europe official said at a Thursday news briefing. WHO Europe's Regional Director Hans Kluge stressed that lockdowns should be a "last resort," and urged the public to follow guidance to help to prevent deaths. He said that if 95% of people wore masks, instead of the current 60%, "lockdowns would not be needed" -- although he added that mask use was not a "panacea" and needed to be combined with other measures. "If we all do our share, lockdowns are avoidable," Kluge said.
19th Nov 2020 - CNN

Coronavirus vaccines: China's Sinopharm claims it has given vaccine to nearly one million people

Sinopharm's chairman said there were no reports of 'serious adverse reactions' He said doses had been given out through China's emergency-use programme He boasted his firm 'is leading the world in all aspects' of coronavirus vaccines Comes after jabs from Pfizer and Moderna were revealed to be 95% effective Oxford University's jab is also found to be 'safe' in people of all ages by a study
19th Nov 2020 - Daily Mail

Social connections with COVID-19–affected areas increase compliance with mobility restrictions

We study the role of social connections in compliance of U.S. households with mobility restrictions imposed in response to the coronavirus disease 2019 (COVID-19) pandemic, using aggregated and anonymized Facebook data on social connections and mobile phone data for measuring social distancing at the county level. Relative to the average restriction efficacy, a county with one-SD more social connections with China and Italy—the first countries with major COVID-19 outbreaks—has a nearly 50% higher compliance with mobility restrictions. By contrast, social connections of counties with less-educated populations, a higher Trump vote share, and a higher fraction of climate change deniers show decreased compliance with mobility restrictions. Our analysis suggests that social connections are conduits of information about the pandemic and an economically important factor affecting compliance with, and impact of, mobility restrictions.
19th Nov 2020 - Science Advances

SA Covid lockdown: experts doubt state suffering 'particularly sneaky strain'

South Australian premier Steven Marshall has said part of the reason for the state’s sudden and strict six-day lockdown is that the state is facing “particularly sneaky strain” of Covid-19 [SARS-CoV-2]. “[It’s a] highly contagious strain … and if we don’t get on top of that very, very quickly it will get away from us and that will be disastrous for us in South Australia,” he said on Thursday. “We have a particularly difficult strain of the disease, which is showing no symptoms for people who become infected. The other thing that we know is that the incubation period for this particular strain is very short, and it can be down to 24 hours.”
19th Nov 2020 - The Guardian

Larry Brilliant Says We’ll Beat Covid—After We Go Through Hell

DICKENSIAN. That’s a term that rolled off epidemiologist Larry Brilliant’s tongue when I spoke to him in one more marathon interview this past weekend. He was not referring to the horrific descriptions of human suffering in the celebrated 19th century novelist’s works—though as we speak, the near-term picture he paints of our pandemic crisis does have images, of bodies stacked in refrigeration vans, that are, well, Dickensian. Instead, he is referencing the opening line of A Tale of Two Cities: “It was the best of times, it was the worst of times …”
19th Nov 2020 - Wired UK

Arthritis drug offers hope for severely ill Covid patients

Scientists have found that a drug used to fight rheumatoid arthritis leads to significantly improved outcomes for severely ill Covid-19 patients, the latest breakthrough in the search for a potential treatment. Tocilizumab, an immunosuppressant drug, was found to be so effective in randomised controlled clinical trials involving 303 patients, that the researchers have been told to stop recruiting people to the “no treatment group”. It is the first immune-modulating drug found to have an effect on outcomes of hospitalised Covid-19 patients, adding to positive results from the cheap and plentiful steroid dexamethasone, and the antiviral drug remdesivir.
19th Nov 2020 - Financial Times

Oxford Covid vaccine trial confirms encouraging results for the elderly

The coronavirus vaccine under development by Oxford university and AstraZeneca has elicited a strong immune response and been shown to be safe in older adults, a group at disproportionate risk of developing severe Covid-19. In phase 2 trial results published in The Lancet, researchers said the vaccine had fewer adverse effects in older people than in younger adults, and that it produced a similar immune response in both groups. The Financial Times first reported on the promising data last month. Testing of the Oxford-AstraZeneca vaccine is at an earlier stage than work on vaccines from Moderna and Pfizer-BioNTech, which trials suggest could protect about 95 per cent of people from infection.
19th Nov 2020 - Financial Times

WHO advises against Gilead's remdesivir for all hospitalised COVID-19 patients

Gilead’s drug remdesivir is not recommended for patients hospitalised with COVID-19, regardless of how ill they are, as there is no evidence it improves survival or reduces the need for ventilation, a World Health Organization panel said on Friday.
19th Nov 2020 - Reuters

Eli Lilly drug gets FDA nod for emergency use with remdesivir to treat COVID-19

The U.S. Food and Drug Administration on Thursday approved the emergency use of Eli Lilly and Co’s arthritis drug, baricitinib, in combination with Gilead Sciences Inc’s remdesivir, to treat COVID-19 patients. Baricitinib, sold under the brand name of Olumiant, is an FDA-approved oral medication to treat moderately-to-severely active rheumatoid arthritis. The approval was based on a review of the data from a clinical trial of hospitalized COVID-19 patients sponsored by the National Institute of Allergy and Infectious Diseases.
19th Nov 2020 - Reuters

More people are getting COVID-19 twice, suggesting immunity wanes quickly in some

In late June, Sanne de Jong developed nausea, shortness of breath, sore muscles, and a runny nose. At first, she thought it might be lingering effects from her COVID-19 infection in the spring. De Jong, 22, had tested positive on 17 April and suffered mild symptoms for about 2 weeks. She tested negative on 2 May—just in time to say farewell to her dying grandmother—and returned to work as a nursing intern in a hospital in Rotterdam, the Netherlands. But when her symptoms re-emerged, her doctor suggested she get tested again. “A reinfection this soon would be peculiar, but not impossible,” she told De Jong, who by then had again lost her sense of smell and had abdominal pains and diarrhea.
18th Nov 2020 - Science Magazine


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Nov 2020

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Cipla launches 'Covi-G' for COVID-19 rapid antibody detection

Cipla Limited today announced that it signed a licensing agreement with a Belgium-based firm, Multi G for the distribution of their COVID-19 Rapid Antibody test kit, across most Emerging markets and Europe. This licencing agreement is part of Cipla's efforts to enhance global access to life- saving treatments and diagnostic infrastructure for patients in need. As part of this agreement, Cipla will be responsible for distribution of the COVID-19 rapid antibody kit that will be manufactured by MultiG. It is marketed under the brand name 'Covi-G',this was among the earliest Antibody kits to declare CE-compliance and is awaiting approval by ICH country regulators. It has been commercialised in 20+ countries already, with sensitivity and specificity exceeding 92%. It tests for both IgM and IgG antibodies, using a single-prick blood test using of the test result indicator visual interpretation. The kit gives results within 10 minutes.
18th Nov 2020 - PR Newswire.com

Pfizer’s Covid-19 Vaccine 95% Effective in Final Results, Company to Seek Approval Within Days

Pfizer Inc. said it will ask health regulators to authorize its experimental Covid-19 vaccine within days, after reporting the shot was 95% effective in its pivotal study and showed signs of being safe. The company’s plans, announced Wednesday, mean the shot is on track to go into distribution by the end of the year, if the regulators permit.
18th Nov 2020 - The Wall Street Journal

Pfizer ends its COVID-19 vaccine trial with a 95% success rate

Pfizer Inc PFE.N and BioNTech 22UAy.DE could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday. The vaccine’s efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people. The U.S. Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.
18th Nov 2020 - Reuters

Pfizer Covid-19 vaccine has 95% efficacy and is safe, further analysis shows

The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin. The news will excite scientists, public health experts and politici