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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Chinese Scientists Develop Mask That Detects Covid, Flu Exposure

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

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

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

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

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


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

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

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

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

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

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

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

WHO 'strongly advises against' use of two COVID treatments

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

EU regulator backs wider use of AstraZeneca COVID therapy

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

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

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

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

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

Moderna open to supplying COVID vaccines to China, CEO says

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

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

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

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

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

Japan Approves Pfizer and Moderna’s Omicron Boosters for Use

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

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

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


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

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

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

Scientists Found a New Antibody That Neutralizes All COVID Variants

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

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

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

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

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

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

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

Pandemic Readiness Lobby Draws In Biotech, Government Members

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

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

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

So Long to Anthony Fauci, Unlikely Avatar of Polarization

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

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

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

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

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


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

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

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

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

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

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

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

CDC vaccine advisers vote to recommend updated Covid-19 boosters

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

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

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

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

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

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

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

Taiwan approves Omicron-targeted Moderna COVID vaccine

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

CDC Panel Backs Moderna, Pfizer Covid Omicron Boosters

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


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

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Covid-19 Boosters Targeting Omicron Reviewed by CDC Advisers

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

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

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

EU drug agency recommends approval of Covid vaccine boosters for Omicron

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

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

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

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

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

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

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

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

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


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

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

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

Omicron Booster Shots Cleared by FDA to Fight Latest Covid Variants

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

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

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

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

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

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

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

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

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

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

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

Moderna sues Pfizer and BioNTech over COVID-19 vaccine

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

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

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

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

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

Vitamin D mediates crosstalk between COVID-19 and osteoporosis

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

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

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

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

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

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

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

Melbourne launches multimillion-dollar centre for pandemic treatments

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


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

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MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization

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

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

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

Japan OKs third Pfizer shot for children and AstraZeneca COVID treatment

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

MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization

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

Risk factors among pregnant and postpartum women with COVID-19

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

AstraZeneca gains first approval for Evusheld as COVID-19 treatment

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

The growing evidence that Covid-19 is leaving people sicker

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

Japan panel approves AstraZeneca's Evusheld COVID treatment

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

Swiss drugs regulator approves first bivalent Covid-19 booster

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

Moderna patent fight about feathers, not goose

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

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

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

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

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


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

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

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

COVID-19 mortality surveillance in Lebanon

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

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

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

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

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

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

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

Moderna sues Pfizer/BioNTech for patent infringement over COVID vaccine

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

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

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

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

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

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

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


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

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

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

Wait for Bharat's COVID-19 vaccine data continues

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

COVID Has Set Back Childhood Immunizations Worldwide

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

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

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

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

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

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

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

Severe COVID-19 increases risk of future cardiovascular events

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

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

Astudy by Clalit Health Services on the success of treating at-risk COVID-19 patients with the anti-viral drug Paxlovid has shown an impressive 81% reduction in the risk of death from complications of the virus and a 73% decrease in hospitalizations among those aged 65 and older, compared to a control group who did not want to take the medication.
25th Aug 2022 - MSN

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

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

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

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


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

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

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

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

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

Moderna seeks FDA EUA for Covid-19 booster vaccine

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

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

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

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

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

WHO advice on second booster doses for COVID-19

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

COVID-19 vaccine less sensitive to mutations developed in Sweden

A new generation of coronavirus vaccine is being developed by Swedish researchers from the Karolinska Institutet. The vaccine is being specifically designed to be less sensitive to mutations and better equipped for any future strains. The vaccine showed promising results in mice in a newly published study in EMBO Molecular Medicine, and the researchers now hope to be able to take it to safety studies on humans. Matti Sällberg, professor at the department of laboratory medicine, Karolinska Institutet said:“This is a new generation of corona vaccine.
24th Aug 2022 - Labiotech.eu

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

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

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

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

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

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


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

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EMA evaluating Skycovion COVID-19 vaccine

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

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

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

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

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

FDA authorizes Novavax's COVID-19 vaccine for teens

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

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

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

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

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

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

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

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

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

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

Pfizer Inc and BioNTech's vaccine was 73.2% effective in preventing COVID-19 among children aged 6 months through 4 years, new data from the companies showed on Tuesday, two months after the U.S. rollout of the shots began for that age group. The Pfizer-BioNTech, vaccine was authorized for children under 5 years of age in June, based on data that showed the vaccine generated a similar immune response as in older age groups
23rd Aug 2022 - Reuters


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

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

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

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

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

How Small Businesses Tapped Billions in Covid Relief

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

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

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

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

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

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

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

Scientists hope nasal vaccines will help halt Covid transmission

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

EMA evaluating Skycovion COVID-19 vaccine

EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.
22nd Aug 2022 - BioPharma-Reporter


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

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Chinese city swabs freshly caught seafood for Covid-19

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

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

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

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

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

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

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

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

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

WHO recommends Valneva's COVID vaccine

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

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

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


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

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

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

Moderna Names New CFO After Hasty Departure of Predecessor

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

Covid's Harmful Effects on the Brain Reverberate Years Later

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

AstraZeneca Hits Another Covid Hurdle in Slow Evusheld Rollout

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

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

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

Study links reduced myocardial blood flow and COVID-19

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

Time to Stop Using Ineffective Covid-19 Drugs

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

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

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


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

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Another tantalizing step closer to a universal flu vaccine

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

Regulators in Britain approve new COVID-19 vaccine booster

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

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

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

BCG vaccine can protect against Covid, new report finds

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

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

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

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

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

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

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

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

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

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

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

Higher risk of vein blood clots in COVID vs flu patients

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


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

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

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

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

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

Bharat Biotech says Phase 3 trial over, intranasal vaccine safe

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

From nasal vaccines to pills: the next defences against Covid

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

Covid-19: Southampton vaccine trial calls for pregnant women

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

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

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

How efficient is backward contact tracing in COVID-19?

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

The hunt for a universal Covid-19 vaccine

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

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

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


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

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UK Approves First Bivalent COVID-19 Booster Vaccine

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

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

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

Novavax seeks U.S. authorization for COVID vaccine booster

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

Bharat Biotech seeks approval for intranasal coronavirus vaccine

Bharat Biotech has submitted data from Phase 3 clinical trials of BBV154, its intranasal Covid vaccine candidate, to the drug regulator. It has sought approval both as a primary two-dose vaccine, and a heterologous booster shot. A heterologous booster implies that the third or subsequent dose of the vaccine is different from its primary dose. Typically, the primary dose comprises two shots. The Hyderabad-based company claimed that BBV154, which is stable at 2-8 degrees Celsius, is proven to be safe, well-tolerated and immunogenic in the subjects under controlled clinical trials. “Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract. These may provide the potential to reduce infection and transmission. Further studies are being planned,” the company noted on Monday.
15th Aug 2022 - Business Standard

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

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

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

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

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

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

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

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

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

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

Novavax seeks U.S. authorization for COVID vaccine booster

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

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

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

UK first to approve Omicron COVID shot with Moderna nod

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


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

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ONS data reveals significant decrease in COVID-19 antibodies

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

Ceapro and McMaster extend partnership to develop Covid-19 therapy

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

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

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

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

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

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

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

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

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

Pregnant Women Safe to Get Covid mRNA Vaccines, Study Shows

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

Striking Drop in Stress Hormone Predicts Long Covid in Study

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


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

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CDC Drops Quarantine Recommendation After Covid-19 Exposure

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

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

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

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

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

Universal vaccine needed to tackle future Covid waves, study suggests

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

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

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

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

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

COVID rebound is surprisingly common — even without Paxlovid

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

Ensovibep no better than placebo for hospitalised COVID-19 patients

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

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

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

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

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

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

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

Africa CDC hopeful Aspen will get COVID vaccine orders

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


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

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

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

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

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

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

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

Vaccine and drug development boosted by new CSIRO lab

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

Science Is Still in a Race Against the Coronavirus

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

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

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

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

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

Covid-19 vaccination in pregnancy

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

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

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

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

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

Long-COVID treatments: why the world is still waiting

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

Covid symptoms sufferers still have four months after catching virus revealed

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The long reach of long Covid

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

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

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

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

Shares of U.S. vaccine maker Novavax fell about 30% on Tuesday after it cut its annual revenue forecast by half over falling demand for its COVID-19 shot from low- and middle-income nations. Demand for its vaccine is also waning in the United States, where it was authorized for use among adults last month and was expected to be preferred by the skeptics of messenger RNA-based shots from Moderna Inc and Pfizer Inc
9th Aug 2022 - Reuters

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

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

Loss Of Smell Linked To Long Term Covid Cognitive Impairment

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


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

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

People with a stronger immune response to the coronaviruses that cause common cold-like symptoms may be better protected against covid-19, raising hopes that a pan-coronavirus vaccine could be achieved. Ricardo da Silva Antunes at La Jolla Institute for Immunology in California and his colleagues analysed blood samples collected from 32 people between 2016 and 2019, before covid-19 emerged. Multiple samples were taken from each person over six months to three years. The team wanted to see how the immune cells in these samples responded to four coronaviruses that cause common cold-like symptoms as well as the original SARS-CoV-2 strain, which emerged in Wuhan, China, at the end of 2019.
9th Aug 2022 - New Scientist

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

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

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

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

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

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

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

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

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

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

SyneuRx reveals results of COVID-19 candidate trial

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

Cellex drops patent case over Siemens COVID-19 tests

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

BioNTech expects Omicron-adapted vaccine deliveries as soon as October

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


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

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

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

80 fresh COVID-19 cases in Sikkim

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

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

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

Covid cases rise sharply, 446 infections recorded

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

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

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

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

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

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

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


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

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

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

Studies: 3 or 4 COVID vaccine doses protective against Omicron

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

South Africa reports first death causally linked to COVID vaccine

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

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

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

People vaccinated against Covid share common symptom after testing positive

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


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

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

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

Moderna Profit Falls Amid Charges for Unused Covid-19 Vaccines

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

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

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

Moderna's COVID vaccine approved for vulnerable young children

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

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

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

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

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

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

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

Moderna Sales Climb on Strong Demand for Covid-19 Vaccine

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

Gilead Boosts Sales Forecast on Demand for Covid-19 Drug

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

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

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

The curious case of the Covid-19 rebound

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

Moderna maintains vaccine sales view on lower COVAX orders

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

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

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

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

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

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

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

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

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


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

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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

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

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

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

Fewer pregnant women had severe COVID amid Omicron, after vaccination

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

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

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

People vaccinated against Covid share common symptom after testing positive

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

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

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

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

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

Life expectancy drops for Native Americans due to COVID-19

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

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

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

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

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

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

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

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

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

Covid-19: is omicron less lethal than delta?

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

Axcella long COVID treatment helps some patients in small trial

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


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

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Polio found in New York wastewater as state urges vaccinations

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

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

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

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

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

SK Bioscience eyes Europe as market for COVID-19 vaccine

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

COVID's deadly 'payback period'

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

AstraZeneca lifts revenue guidance on COVID treatment

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

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

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

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

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


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

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

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

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

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

CityU researchers invents accurate rapid COVID-19 antibody level test

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

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

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

In Rural America, Covid Hits Black and Hispanic People Hardest

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

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

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

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

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

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

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

COVID-19 Moderna vaccine induces significant antibody reactions among children

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

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

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

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

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

Pfizer profit beats estimates on higher demand for COVID products

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

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

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

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

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

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

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


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

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Novavax Covid-19 vaccine gets Australian TGA approval for adolescents

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

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

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

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

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

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

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

New studies bolster theory coronavirus emerged from the wild

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

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

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

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

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

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

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

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

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

Pfizer starts mid-stage trial for vaccine against Omicron subvariant

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

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

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

CDC to make monkeypox nationally notifiable condition

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


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

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

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

Monkeypox Proves Elusive Foe as WHO Sounds Alarm on Global Spread

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

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

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

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

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

COVID-19 antivirals may cut risk of hospitalization, death

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

Diabetes risk remains elevated three months after COVID-19 infection

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

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

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

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

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

Monkeypox Vaccine Maker Bavarian Nordic Considers 24-Hour Emergency Production

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

Pandemic Drinking Led to Thousands of UK Hospital Admissions, Deaths

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

Mysterious Hepatitis Cases in Children May Have Complex Cause

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

Getting Around After the Pandemic Will Be a Shared Exercise

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

Feds look ahead to next-generation COVID vaccines

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

China approves Genuine Biotech's HIV drug for COVID patients

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

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

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

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

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

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

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

Scientists identify how the coronavirus spike protein causes heart damage

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


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

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

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

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

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

WHO Chief Overrules Panel to Declare Monkeypox Global Emergency

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

COVID: Is the virus getting smarter?

Coronavirus infections are surging as the virus evolves, becoming "too clever", according to the World Health Organisation's special envoy on COVID-19, David Nabarro. With figures suggesting nearly three million people in the UK are still unvaccinated, what can be done to encourage those people to get their jabs, and is the virus becoming too smart for our vaccines to keep up? On the Sky News Daily with Niall Paterson, the WHO's Mr Nabarro explains why it's still important to keep protected from coronavirus, and vaccination champion Wendy Francis-White shares her experience helping to get jabs in the arms of those who are vaccine hesitant.
24th Jul 2022 - Sky News

Two symptoms that mean you should 'assume you have Covid', professor says

Article reports that a professor has warned people over two symptoms that probably mean they have Covid. With free tests stopped for the majority in April, it is harder for people to spot they have the virus. Omicron BA.5 is now the dominant Covid strain, accounting for approximately 79% of UK cases as of July 18. Professor Tim Spector, who heads up the ZOE Health Study, said people should assume they do have coronavirus if they wake up with a sore throat and fatigue, despite getting a good night's sleep, The Mirror reports. Professor Spector tweeted: "Twice as many covid cases as common colds currently- the ratio has never been so high. Symptoms much the same except generally more fatigue and sore throat - so best to assume it’s Covid!
23rd Jul 2022 - Birmingham Live

COVID Virus May Tunnel through Nanotubes from Nose to Brain

SARS-CoV-2, though, may have come up with an ingenious work-around. It may completely do away with the molecular maneuverings needed to attach to and unlock a cell membrane. Instead it wields a blunt instrument in the form of nanotube “bridges”—cylinders constructed of the common protein actin that are no more than a few tens of nanometers in diameter. These tunneling nanotubes extend across cell-to-cell gaps to penetrate a neighbor and give viral particles a direct route into COVID-impervious tissue. Researchers at the Pasteur Institute in Paris demonstrated the prospects for a nanotube-mediated cell crossing in a study in a lab dish that now needs to be confirmed in infected human patients.
23rd Jul 2022 - Scientific American

Children who suffer four symptoms could develop Long Covid, study finds

Children who show at least four symptoms are most at risk of suffering from Long Covid, according to new research. The international study found the most common symptoms to be fatigue or weakness, cough, difficulty breathing or shortness of breath. Researchers also found hospitalisations for 48 or more hours and being aged 14 or older are other aggravating factors. These findings could help identify vulnerable individuals who are more susceptible to Long Covid. Lead author Professor Stephen Freedman of the University of Calgary, Alberta, Canada, explained: "We found in some children, illness with Covid-19 is associated with reporting persistent symptoms after three months. Our results suggest appropriate guidance and follow-up are needed, especially for children at high risk for Long Covid."
23rd Jul 2022 - Daily Record

There's a new COVID-19 Omicron subvariant, so what is BA.2.75 and why are some people calling it 'Centaurus'?

Since the COVID-19 pandemic first began, many have become desensitised to these next few words: There's a new Omicron subvariant. BA.2.75 was first detected in India in early May. Since then, it's been found in Europe and the United States. The chief scientist with the World Health Organization (WHO), Soumya Swaminathan, said BA.2.75 appeared to have mutated in a way that could indicate "major immune escape". However, Dr Swaminathan says there isn't enough data to know how severe its impact will be. Here's what we know so far:
23rd Jul 2022 - ABC News

WHO Declares Monkeypox a Global Health Emergency

The World Health Organization has declared that monkeypox is a public-health emergency of international concern as global case numbers surpass 16,000. This is the first time the WHO has declared a global health emergency since the start of the Covid-19 pandemic in January 2020. The WHO’s director-general, Dr. Tedros Adhanom Ghebreyesus, said the emergency committee believes the risk is moderate globally, except in the European region where it assesses the risk as high.
23rd Jul 2022 - The Wall Street Journal

‘Covid is not going to go away’: Australia will require public health measures for foreseeable future, say experts

In May 2021, Australia’s chief medical officer, Prof Paul Kelly, described how Covid vaccines were our “ticket out of the pandemic”. Vaccination, he said, would give Australians “a life with more certainty”. More than one year later, Australia’s Covid-19 vaccination rate is among the highest in the world. Yet daily deaths from the virus remain in the double-digits. Hospitals are overwhelmed, aged care homes and the most vulnerable are struggling with outbreaks, and there is again debate about whether more social restrictions, including mask mandates, are needed to curb virus spread. Infectious diseases expert and director of the Doherty Institute, Prof Sharon Lewin, said: “Last year, I definitely did not think we would be in this position.”
22nd Jul 2022 - The Guardian

New study estimates how many children will get long Covid

An international study estimates the prevalence of long Covid in children to be anywhere from 5% to 10% — a figure that's far lower than estimates of long Covid in more than a third of adults. The findings, published Friday in the journal JAMA Network Open, also suggested that several factors could predict which children with Covid may have ongoing symptoms or develop new ones in the 90 days following infection. Those include having seven or more symptoms during the initial phase of illness and hospitalization for more than two days. Age was also a factor: Long-term symptoms were more prevalent in children 14 years and older.
22nd Jul 2022 - NBC News

WHO Prioritizes Health Care Workers And Older Populations in Latest COVID-19 Vaccination Strategy Update

After missing the target to vaccinate 70% of people in every country against COVID by July 2022, WHO’s new vaccine strategy prioritises 100% coverage for health workers and older people – but admits that every country will have to decide for itself. The World Health Organization has published an update to the Global COVID-19 Vaccination Strategy that preserves its 70% global vaccination target and 100% vaccination targets for health care workers and older populations, but acknowledges that countries will still need to determine their ‘context-specific targets’ for their own COVID-19 national vaccination programmes.
22nd Jul 2022 - Health Policy Watch


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

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Antigen tests show more than 20,000 new Covid infections per day

The country registered 23 more Covid-19 fatalities and 2,607 new cases admitted to hospital during the previous 24 hours, the Public Health Ministry announced on Thursday morning, but government data showed an average of more than 20,000 positive antigen tests over the past week.
21st Jul 2022 - Bangkok Post on MSN.com

COVID-19 Vaccine Linked to Short-Term Changes in Menstrual Cycle Length, Study Suggests

A new study shows that women may experience short-term changes in their menstrual cycles after COVID-19 vaccination. The researchers found that these changes were associated with all COVID-19 vaccine types.
21st Jul 2022 - Prevention

CDC endorses more traditional Novavax COVID shot for adults

U.S. adults who haven’t gotten any COVID-19 shots yet should consider a new option from Novavax -- a more traditional kind of vaccine, health officials said Tuesday. Regulators authorized the nation’s first so-called protein vaccine against COVID-19 last week, but the final hurdle was a recommendation from the Centers for Disease Control and Prevention. “If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Dr. Rochelle Walensky, CDC’s director, said in a statement, endorsing an earlier decision from an influential advisory panel.
21st Jul 2022 - Associated Press

COVID-19 tied to new-onset, short-term heart disease, diabetes

COVID-19 patients are six times more likely than uninfected people to develop cardiovascular disease (CVD) and nearly twice as likely to receive a new diabetes diagnosis, but the risk begins to recede at 5 weeks and 12 weeks, respectively, concludes a UK study published yesterday in PLOS Medicine.
20th Jul 2022 - CIDRAP

BLOOM Shionogi Covid Pill Xocova Fails to Win Japan Panel Backing

Shionogi & Co.’s experimental Covid-19 treatment Xocova failed to win the backing of health experts in Japan who said there wasn’t enough data to show the medicine’s efficacy. The panel members didn’t recommend that Japan’s health ministry authorize emergency use of the therapy as there was a need to continue discussion on it, Hiroshi Kiyota, chairman of the expert committee said in a briefing Wednesday. The health ministry relies on the panel’s decision to give the approval.
20th Jul 2022 - Bloomberg


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

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With COVID and influenza on the rise, how worried should pregnant women be?

When Alix Mellor fell ill with COVID, she cycled through the full gambit of symptoms: coughing throughout the night, soaring temperatures and unforgiving physical fatigue. But it was the thing she couldn't feel that really made her worry. Days into the infection and 34 weeks pregnant, she noticed her baby was uncharacteristically still. "I called the midwives and they said to come into the hospital and they did some fetal monitoring to make sure the baby is OK," the Melbourne mother says. "It was in my mind that it's not just about me, it's about the baby." It was the second time in three weeks the Melbourne mother had found herself at the hospital with a respiratory illness. The first was with a nasty bout of influenza which saw her hospitalised for four days with a "really high pulse rate". Women who test positive for COVID while pregnant have a higher risk of hospitalisation and ventilation than those who aren't pregnant and are also at greater risk of premature birth and stillbirth. It's a similar situation for the flu, which can be deadly for expectant mothers.
20th Jul 2022 - ABC News

CDC endorses more traditional Novavax COVID shot for adults

U.S. adults who haven’t gotten any COVID-19 shots yet should consider a new option from Novavax -- a more traditional kind of vaccine, health officials said Tuesday. Regulators authorized the nation’s first so-called protein vaccine against COVID-19 last week, but the final hurdle was a recommendation from the Centers for Disease Control and Prevention. “If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Dr. Rochelle Walensky, CDC’s director, said in a statement, endorsing an earlier decision from an influential advisory panel.
20th Jul 2022 - The Associated Press

Weekly tests dropped for unvaccinated state employees

Minnesota state government employees who are unvaccinated for COVID-19 are no longer required to take weekly tests for the virus in order to stay in the workplace. The requirement that went into effect in September 2021 meant thousands of employees took tests each week. Those that didn’t comply were subjected to suspensions or other discipline. A state official said the requirement was rescinded because of the evolving nature of the virus. “Whereas it was common to have broad, uniform precautionary measures earlier in the pandemic, the pandemic is at a point where public health COVID-19 risk assessments and precautions are now more dependent upon the specific circumstances of individuals and communities,” said Patrick Hogan, Department of Minnesota Management and Budget spokesman.
20th Jul 2022 - The Associated Press

As BA.5 Spreads, How Long Will a Prior Covid-19 Infection Protect You?

If you have had Covid-19, how long can you expect to be protected from another infection? Doctors say the window between infections might be shrinking, fueled in part by the immune-evading Omicron BA.5 subvariant, although researchers are still gathering data. The U.S. Centers for Disease Control and Prevention has long set 90 days as its window for what counts as a new Covid-19 infection—meaning that symptoms or positive Covid tests within 90 days of a prior infection have been considered the same infection. Getting reinfected sooner has always been possible but uncommon. Now, reinfections are happening more often and can occur closer in time, say infectious-disease specialists and epidemiologists. They cite the march of new subvariants emerging and circulating simultaneously as well as BA.5’s ability to evade immune protections. In addition, doctors note, people are taking fewer precautions, such as masking indoors or avoiding large gatherings.
20th Jul 2022 - The Wall Street Journal

Novavax Covid Shot for Adults Gains CDC Advisers' Backing

Novavax Inc.’s shares surged after its Covid-19 vaccine won backing from a panel of US public health advisers, a crucial step in providing officials with another tool against the virus as cases start to rise again. The 12-member panel of outside experts convened by the Centers for Disease Control and Prevention voted unanimously to recommend the shots for adults. CDC Director Rochelle Walensky signed off on the advice from the Advisory Committee on Immunization Practices, which allows the shot to finally go into arms. The stock gained 12% at the close of New York trading Tuesday.
20th Jul 2022 - Bloomberg

Shionogi Covid Pill Xocova Fails to Win Japan's Panel Backing

Shionogi & Co.’s experimental Covid-19 treatment Xocova failed to win the backing of health experts in Japan who said there wasn’t enough data to show the medicine’s efficacy. The panel members didn’t recommend that Japan’s health ministry authorize emergency use of the therapy as there was a need to continue discussion on it, Hiroshi Kiyota, chairman of the expert committee said in a briefing Wednesday. The health ministry relies on the panel’s decision to give the approval.
20th Jul 2022 - Bloomberg


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

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More (mostly mild) side effects when flu vaccine given with COVID booster

Self-reported data from nearly 1 million Americans show an 8% to 11% higher rate of mostly mild systemic adverse events after simultaneous seasonal flu vaccine and mRNA COVID-19 booster (third) doses than with the COVID-19 booster alone. In the study, published today in JAMA Network Open, the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team and Emory University analyzed rates of systemic adverse events among 981,099 Americans aged 12 years and older in the week after either simultaneous flu and COVID-19 booster doses or the booster alone from Sep 22, 2021, to May 1, 2022. Volunteers responded to at least one health survey through the CDC's smartphone-based v-safe monitoring system during the study period.
17th Jul 2022 - Cidrap.umn.edu

A riskier approach to new vaccines will pay off

The UK has been hit by three consecutive waves of Omicron variants, each one appearing in a matter of weeks. If a future variant proves much more dangerous, we will not have much time to brace for impact. So what can be done? The answer: develop better vaccines. The simplest approach is, as with flu, to try to predict where the virus will be four to six months ahead, and to make booster doses accordingly. That looks feasible. After scaling up to meet demand for vaccines in 2021, the world has “unprecedented production capacity”, says Rasmus Bech Hansen, founder of Airfinity, a health analytics company — enough to produce another 8bn doses this year. But better, if we can figure out how to do it, is to make a vaccine that targets all Sars-Cov-2 variants, or a wider family of coronaviruses including Sars or, even more ambitiously, all coronaviruses.
15th Jul 2022 - Financial Times

COVID-19 has become 'too clever for us' and can 'break past' our protection, WHO official says

WHO special envoy David Nabarro told Sky News on Thursday that the reason for a surge in new COVID-19 cases globally is because the virus "changed yet again, and it's become too clever for us." "This virus is capable of constantly evolving and changing," he told the outlet. "It can break past our immune defenses, and that's why the numbers are going up." Nabarro told Sky that taking precautions against the virus, like ensuring people are up to date on their COVID-19 vaccination shots, is still important to keep others safe.
15th Jul 2022 - Business Insider on MSN.com

FDA delays decision on BeiGene's cancer drug on China COVID curbs

China-based drug developer BeiGene said on Thursday the U.S. Food and Drug Administration has delayed a decision on its cancer drug as COVID-19 curbs in the country prevented the regulator from conducting inspections. The FDA was expected to decide on the drug, tislelizumab, by July 12 but has now delayed its move until the inspections are complete, the company said. The delay makes BeiGene the latest China-based company for which the FDA has cited pandemic travel restrictions as an issue following similar problems with Hutchmed Ltd , as well as U.S.-based Coherus BioSciences Inc (CHRS.O) and its Chinese partner Shanghai Junshi Biosciences Co Ltd
15th Jul 2022 - Reuters

Pfizer, Biontech seek Japan regulatory approval of COVID shot for young children

Pfizer Inc and BioNTech SE have sought approval from Japan's health ministry for use of their COVID-19 vaccine for use in children aged six months to four years, the companies said in a statement on Thursday. The filing follows approval last month by U.S. regulators for Moderna Inc's two-dose vaccine and the Pfizer-BioNTech three-shot regimen for children in the same age group.
15th Jul 2022 - Reuters

Canada clears Moderna's COVID vaccine for children under 5

Canada on Thursday authorized Moderna Inc's COVID-19 vaccine for babies as young as 6 months old, making it the country's first vaccine against coronavirus for children under 5, Health Canada said. Canada had been offering Moderna's Spikevax vaccine to children above 5 since March, and the latest authorization means some 1.7 million more children are now eligible for inoculation against COVID, according to Health Canada.
15th Jul 2022 - Reuters

EU adds severe allergies as side effect of Novavax COVID vaccine

The European Medicines Agency on Thursday identified severe allergic reactions as potential side effects of Novavax Inc's (NVAX.O) COVID-19 vaccine. The vaccine was authorized by U.S. regulators on Wednesday, and its product label in the United States warns against administering the shot to people with a history of allergic reactions to any components of the shot. Shares of Novavax fell 20.3% to $55.72 in morning trading, along with the broader market and other COVID-19 vaccine makers. Novavax shares are usually volatile.
15th Jul 2022 - Reuters

From AstraZeneca to Novavax: Serum Institute wins FDA nod to supply new COVID shot to US from India

With an FDA authorization for Novavax’s Nuvaxovid, Serum Institute of India (SII) has scored the go-ahead to finally supply a COVID-19 vaccine to the U.S. Wednesday’s emergency use authorization for Novavax’s recombinant protein-based vaccine means SII is able to supply the shot, also known as Covovax, to the U.S. from India. SII has been producing AstraZeneca’s Vaxzevria, but that adenovirus-vectored vaccine isn’t available in the U.S. The Novavax green light now makes SII the first Indian drugmaker to produce a COVID shot for the U.S. market.
15th Jul 2022 - FiercePharma

UK weekly COVID-19 infections rise, booster jab programme announced

An estimated 3.5 million people in Britain had COVID-19 in the latest week of available data, the Office for National Statistics (ONS) said on Friday, up nearly 30% on the 2.7 million recorded in the previous week. Separately, the government announced that a new COVID booster jab programme would begin later this year. "The percentage of people testing positive for coronavirus (COVID-19) continued to increase across the UK," the ONS said. "These increases were likely caused by increases in infections compatible with Omicron variants BA.4 and BA.5."
15th Jul 2022 - Reuters

FDA green-lights Novavax vaccine as COVID-19 levels rise

The FDA's approval allows distribution of the vaccine to begin, but before health providers can administer it, the Centers for Disease Control and Prevention (CDC) must recommend it. The CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to discuss the topic on Jul 19. In its announcement, the FDA said the vaccine is approved for use as a two-dose primary series in adults (ages 18 and older). The vaccine is made on a more traditional platform, which officials hope will sway more people to become immunized. The vaccine contains the SARS-CoV-2 spike protein produced in insect calls and contains the Matrix-M adjuvant as an immune booster. The FDA's announcement yesterday came more than a month after its vaccine advisory board recommended EUA approval. Earlier this week, the Biden administration announced the purchase of 3.2 million Novavax doses.
14th Jul 2022 - CIDRAP


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

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Health Canada approves first COVID-19 vaccine for youngest kids

Canada's drug regulator approved Moderna's COVID-19 vaccine for infants and preschoolers Thursday, making it the first vaccine approved for that age group in the country. Health Canada now says the Moderna vaccine can be given to young children between the ages of six months and five years old in doses one-quarter the size of that approved for adults. “After a thorough and independent scientific review of the evidence, the department has determined that the vaccine is safe and effective at preventing COVID-19 in children between 6 months and 5 years of age,” the department said in a statement.
14th Jul 2022 - CTV News

Alnylam accuses Pfizer, Moderna of infringing a second patent

Alnylam is adding more fuel to the fire in its infringement lawsuits against Pfizer and Moderna, claiming both companies violated a patent that was just granted to the company on Tuesday. The fight is over mRNA technology Pfizer and Moderna used in developing their respective COVID-19 vaccines, Alnylam says. Alnylam originally filed lawsuits against each in March. On Tuesday in lawsuits filed in U.S. district court in Delaware, Alnylam said that its newly granted patent covers a specific class of lipid nanoparticles (LNPs) and how they are manufactured. LPLs deliver genetic material into cells.
14th Jul 2022 - FiercePharma

FDA delays decision on BeiGene's cancer drug on China COVID curbs

China-based drug developer BeiGene said on Thursday the U.S. Food and Drug Administration (FDA) has delayed a decision on its cancer drug as COVID-19 curbs in the country prevented the regulator from conducting inspections. The FDA was expected to decide on the drug, tislelizumab, by July 12 but has now delayed its move until the inspections are complete, the company said. The delay makes BeiGene the latest China-based company for which the FDA has cited pandemic travel restrictions as an issue following similar problems with Hutchmed Ltd , as well as U.S.-based Coherus BioSciences Inc and its Chinese partner Shanghai Junshi Biosciences Co Ltd
14th Jul 2022 - Reuters

AstraZeneca says COVID vaccine as effective as mRNA shots in review

AstraZeneca said on Wednesday a review of real-world data showed its COVID-19 vaccine provided equally effective protection against hospitalisation and death after two doses as with current mRNA shots from Pfizer and Moderna
14th Jul 2022 - Reuters

Pfizer, Biontech seek Japan regulatory approval of COVID shot for young children

Pfizer Inc and BioNTech SE have sought approval from Japan's health ministry for use of their COVID-19 vaccine for use in children aged six months to four years, the companies said in a statement on Thursday. The filing follows approval last month by U.S. regulators for Moderna Inc's two-dose vaccine and the Pfizer-BioNTech three-shot regimen for children in the same age group. The majority of COVID vaccinations in Japan have used the Pfizer vaccine, authorised by regulators for children aged five to 11 in January
14th Jul 2022 - Reuters

WHO Panel Advises Against Generic Antidepressant to Treat Covid

A generic antidepressant and a gout medicine that garnered some popularity as Covid-19 treatments shouldn’t be used for mild infection because there’s no evidence they help, according to a panel of experts advising the World Health Organization. The drugs, fluvoxamine and colchicine, could potentially cause harm, the group of experts said in the BMJ medical journal Thursday. The panel didn’t give advice for severe illness, saying there was a lack of data.
14th Jul 2022 - Bloomberg

How long after exposure you can test positive and early signs to look for

Covid rates are continuing to increase, and more and more people are testing positive across the UK. The Zoe Health Study produced data this week showing that there were over 350,000 daily Covid cases – a new record for the UK. Professor Tim Spector, Zoe scientific co-founder and lead scientist on the Zoe Health Study, said: “Covid is still rampant in the population. “So much so that if you have any cold-like symptoms at the moment it’s nearly twice as likely to be Covid as a cold. “Even if people have had a past infection and are fully vaccinated, people are still catching it.” Here’s everything you need to know about how quickly you will show symptoms.
14th Jul 2022 - iNews

Study: Kids have stronger COVID-19 antibody response than adults

A new prospective study of 252 families with members diagnosed as having mild COVID-19 in Italy finds that, while all age-groups had detectable SARS-CoV-2 antibodies up to 1 year after infection, children—especially those younger than 3 years—had higher antibody levels than adults at all intervals tested. In the study, published today in JAMA Network Open, a team led by University of Padua researchers enrolled 902 unvaccinated patients at a COVID follow-up clinic from Apr 1, 2020, to Aug 31, 2021. Families were included in the study if they had children younger than 15 years and at least one member who had tested positive for COVID-19 at least 4 weeks earlier.
13th Jul 2022 - CIDRAP

Novavax, at long last, clinches FDA emergency nod for protein-based COVID shot

The U.S. FDA gave the all-clear to Novavax’s adjuvanted, protein-based shot, teeing up the nation’s fourth pandemic prophylactic behind those from Pfizer-BioNTech, Moderna and Johnson & Johnson. The FDA’s emergency use authorization covers the prevention of COVID-19 caused by SARS-CoV-2 among adults ages 18 and up. The company aims to file a full biologics license application by year-end and figures it will be the last COVID vaccine player blessed with an emergency nod, Novavax’s John Trizzino, executive vice president, chief commercial officer and chief business officer, told Fierce Biotech at this year’s BIO International Convention.
13th Jul 2022 - Fierce Pharma


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

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FDA Authorizes Novavax’s Covid-19 Vaccine

U.S. health regulators have authorized the use of Novavax Inc.’s Covid-19 vaccine, providing a new option that works differently than the two leading vaccines, but at a time when overall demand for vaccines and boosters is low. The Food and Drug Administration said Wednesday that adults 18 years and older may receive Novavax’s vaccine. The Novavax vaccine, given as two doses three weeks apart, could become available soon if the Centers for Disease Control and Prevention signs off in the coming days. The authorization gives adults “another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency-use authorization,” FDA Commissioner Robert M. Califf said.
14th Jul 2022 - The Wall Street Journal

Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines

AstraZeneca’s (AZ) COVID-19 vaccine, Vaxzevria, and the available mRNA COVID-19 vaccines provide ‘equally effective’ protection against hospitalisation and death, an expert review of data from 79 real-world studies has revealed. Infectious disease experts from Asia reviewed data from the VIEW-hub database on vaccine use and impact, developed by John Hopkins Bloomberg School of Public Health and the International Vaccine Access Center. The findings from the study were reported by Expert Review of Vaccines. The findings shows that Vaxzevria and the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines offer an ‘equivalent degree’ of protection against hospitalisation (91-93%) and death (91-93%) following two doses, regardless of age.
13th Jul 2022 - PMLiVE

Covid vaccine 66 per cent less effective at preventing infection than it was just two months ago, expert says

Covid cases have hit record levels in the UK, yet the vaccine is less effective at preventing infection than at any time since it was introduced, according to a leading virus modeller. The degree of protection a jab gives against getting a Covid infection has tumbled from about 30 per cent two months ago to about 10 per cent today, according to Professor Karl Friston, of University College London. This is largely because the new dominant Omicron subvariants, BA.4 and BA.5, are much better at evading immunity built up by vaccinations than their predecessor, BA.2, he says.
13th Jul 2022 - iNews

How long after catching Covid can you become reinfected and when should you get your booster?

People may become reinfected with Covid-19 as early as 28 days after recovering from the virus, according to the latest advice from the Australian Health Protection Principal Committee. Previously, reinfection was defined as a case occurring more than 12 weeks after an initial infection. The committee said the Omicron subvariants BA.4 and BA.5 “are associated with increased immune escape and we are likely to see rates of reinfection rise among those who have previously been infected with an earlier Covid-19 variant, and those who are up to date with their vaccinations”.
13th Jul 2022 - The Guardian

Covid-19: Researchers face wait for patient level data from Pfizer and Moderna vaccine trials

Independent researchers looking to obtain patient level data from the Pfizer and Moderna covid-19 vaccine trials may have to wait longer. In status reports filed recently with the US federal trials registry (clinicaltrials.gov) between February and May, both companies extended the dates by which the trials will be completed, Pfizer by nine months, from 15 May 2023 to 8 February 2024. Moderna’s expected completion date is delayed from 27 October to 29 December 2022. Pfizer indicated in its trial protocol that individual participant data would be made available two years after study completion.1 Now that the date has been pushed back, Pfizer will entertain and review requests “when the study is complete and all planned analyses have been performed,” said the company’s senior director of global media relations, Jerica Pitts. Luis Carlos Saiz, a researcher at the Innovation and Organisation Unit of the Navarre Regional Health Service, Spain, said that access to raw patient data was important for researchers because “it is key to build trust in health policies and to protect citizens from potential vested interests.”
13th Jul 2022 - The BMJ

Pfizer, Moderna COVID-19 vaccines infringe new Alnylam patent, lawsuits say

Alnylam Pharmaceuticals Inc escalated its patent fight with Pfizer Inc and Moderna Inc over their COVID-19 vaccines on Tuesday, accusing the companies in Delaware federal court of infringing a newly obtained patent. The lawsuits said the vaccines' messenger-RNA delivery systems violate an Alnylam patent on lipid nanoparticle (LNP) technology for delivering genetic material into human cells. The U.S. Patent and Trademark Office issued the patent the same day Alnylam filed the complaints.
13th Jul 2022 - Reuters

Adapted, two-strain vaccines to lift COVID protection - EU official

Adapted versions of established mRNA COVID-19 vaccines that address two variants in one shot will soon offer people better protection than vaccines that are now available, a European health official said on Wednesday. Moderna and the BioNTech-Pfizer alliance are working on vaccines based on a combination of the original Wuhan virus and an Omicron subvariant. Referred to as bivalent shots, these are planned for use in the autumn vaccination campaign.
13th Jul 2022 - Reuters


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What is the long-term protection against COVID-19?

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is known to cause many clinical manifestations. The protection conferred by prior infection or vaccination against infection over the long term is poorly understood. A new paper in Immunological Reviews describes the immunologic parameters associated with protection from COVID-19.
12th Jul 2022 - News-Medical.Net

Australia's CSIRO develops machine learning tool that spots emerging COVID-19 variants

CSIRO did not mention how they developed the AI tool called VariantSpark but it was used to analyse around 10,000 COVID-19 samples in a new study, whose findings were published in the peer-reviewed journal Computational and Structural Biotechnology Journal. The researchers worked with both Intel and ACT-based cloud system provider RONIN on the said study. According to a media release, VariantSpark can provide hourly updates, enabling the quick sharing of information with public health decision-makers and helping hospitals prepare for potential increases in admissions.
12th Jul 2022 - Healthcare IT News

Nitric oxide boosts oxygen in pregnant women with COVID-19 pneumonia

Inhaled high-dose nitric oxide (INO200) safely shortened time on supplemental oxygen and hospital stays among pregnant women diagnosed as having severe bilateral COVID-19 pneumonia, suggests a new study led by Massachusetts General Hospital (MGH) researchers. COVID-19 pneumonia is an especially dire diagnosis for pregnant women because it can rapidly lower oxygen in the blood and body tissues, requiring hospital admission and cardiopulmonary support, first author Carlo Valsecchi, MD, said in an MGH news release. "Pregnant women are three times more likely to need intensive care unit admission, mechanical ventilation, or advanced life support, and four times more likely to die," he said. "They also face a greater risk of obstetric complications such as preeclampsia, preterm delivery, and stillbirth."
12th Jul 2022 - CIDRAP

Development of a multiomics model for identification of predictive biomarkers for COVID-19 severity: a retrospective cohort study

COVID-19 is a multi-system disorder with high variability in clinical outcomes among patients who are admitted to hospital. Although some cytokines such as interleukin (IL)-6 are believed to be associated with severity, there are no early biomarkers that can reliably predict patients who are more likely to have adverse outcomes. Thus, it is crucial to discover predictive markers of serious complications.
12th Jul 2022 - The Lancet

White House urges COVID boosters to protect against spreading BA.5 subvariant

BA.5 is estimated to account for 65% of the coronavirus variants circulating in the United States as of last week, said Rochelle Walensky, the director of the U.S. Centers for Disease Control and Prevention (CDC). Officials urged people who are 50 years old or older to get a booster shot and said that would not prevent them from getting another "bivalent" booster designed to fend off Omicron more specifically later this year.
12th Jul 2022 - Reuters

Moderna unveils positive data on new booster candidate

Just a few weeks after the FDA recommended that COVID-19 vaccine manufactures tweak their boosters to zero in on the omicron BA.4 and BA.5 subvariants, Moderna has unveiled promising new data for its prospect. On Monday, the mRNA specialist said its omicron-containing bivalent booster elicited higher neutralizing antibody responses compared with the current booster. After one month, trial participants who received the bivalent booster had BA.4 and BA.5 neutralizing antibodies that were 1.69 times higher than those who received the original booster, the company said.
11th Jul 2022 - FiercePharma


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Moderna Is Developing Two Different Omicron-Targeting Booster Shots

Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries. The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week. In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.
11th Jul 2022 - The Wall Street Journal

Future Covid Variants Can Be Predicted by AI, Startup Claims

As pharmaceutical companies struggle to keep up with the rapidly mutating coronavirus, a startup in Cambridge, Mass., says it can help them by using artificial intelligence to predict future variants. Apriori Bio models the ways a virus might change and predicts how it will behave. The company says it’s harnessing that information to design “variant-proof” vaccines and treatments that can fight current and future strains—and provide an early warning to governments, sort of like a hurricane alert, to guide the public-health response. After honing its technology, called Octavia, for more than two years, the fledgling company is formally launching with $50 million in funding from Flagship Pioneering Inc., the incubator behind Moderna Inc.
11th Jul 2022 - Bloomberg

Italy to start administering second COVID booster to over-60s

Italy will soon start its campaign to administer a second COVID-19 booster to everyone aged over 60, the health minister said on Monday, after receiving a green light from European Union health agencies.
11th Jul 2022 - Reuters

Moderna to advance two Omicron vaccine candidates against newer variants

Moderna Inc said on Monday it was advancing two Omicron vaccine candidates for the fall, one designed against the BA.1 variant and another against the BA.4 and BA.5. Vaccine makers including Moderna and rival Pfizer Inc are developing updated vaccines to target the fast-spreading Omicron subvariants BA.4 and BA.5, which have gained a foothold in the United States over recent weeks. Moderna said its decision to develop the bivalent vaccines was based on different market preferences for shots against the subvariants.
11th Jul 2022 - Reuters

US FDA approves Pfizer-BioNTech’s Covid-19 vaccine for adolescents

The US Food and Drug Administration (FDA) has granted approval for Pfizer and BioNTech’s Supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for adolescents aged 12 to 15 years. Earlier, the regulatory agency granted emergency use authorization (EUA) for the use of the vaccine in this age group and so far over nine million adolescents of this age have received the initial vaccine regimen. Comirnaty is the first Covid-19 vaccine to obtain FDA approval for use in adolescents. The FDA granted approval based on findings from a Phase III clinical trial in 2,260 subjects aged 12 to 15 years.
11th Jul 2022 - Pharmaceutical Technology

BioNTech, Pfizer ask EU to authorize 3-dose COVID-19 vaccine for kids over 6 months

BioNTech and Pfizer Friday announced they had submitted data to the European Medicines Agency backing their three-dose COVID-19 vaccine for children aged 6 months to less than 5 years. The announcement follows the U.S. Food and Drug Administration granting emergency use authorization for the same schedule in its youngest kids on June 17. The three-dose regimen includes a much lower dose than what's given to adults. BioNTech and Pfizer say that the data from the trial, which enrolled over 10,000 children, indicates the three doses in young children elicited a strong immune response and has a favorable safety profile. Adverse reactions were generally less frequent in this age group compared to children aged between 5 and 12. As such, the companies want the EU to expand its conditional marketing authorization to include the youngest children.
11th Jul 2022 - POLITICO

Scared of needles? Inhalable COVID-19 vaccine shows promise in new study

An inhalable COVID-19 vaccine has shown great promise in protecting the lungs against the coronavirus in a new study. Researchers from the US’ North Carolina State University created the inhalable vaccine that is shelf-stable at room temperature for up to three months and specifically works to target the lungs and can be self-administrated through an inhaler.
11th Jul 2022 - Al Arabiya English

4th COVID-19 vaccine effectively protects elderly against Omicron -study

The fourth dose of the coronavirus vaccine is effective in protecting the elderly against the Omicron variant and lowers their risk of death by 72% compared to those who received only three doses, according to a new study conducted by Tel Aviv University and Ben-Gurion University of the Negev in collaboration with the Health Ministry. The study, published in the peer-reviewed JAMA Internal Medicine journal, found that elderly recipients of the fourth dose were 34% more protected against infection than those who received only the third dose at four months previously. Recipients of the fourth dose were also 64-67% less likely to be hospitalized for mild to moderate and severe illness.
11th Jul 2022 - The Jerusalem Post

Moderna's Noubar Afeyan on the race to create a Covid vaccine

Moderna's Noubar Afeyan on the race to create a Covid vaccine with the Financial Times health team
11th Jul 2022 - Financial Times

Could a universal coronavirus vaccine be the silver bullet that ends this pandemic—and the next?

First-generation vaccines were not the panacea hoped for in COVID-19’s early days. Nor did herd immunity swoop in and save the day. Could a so-called “pan-coronavirus” vaccine be the long-awaited silver bullet that ends the COVID pandemic—and the next one, too? Answer: It’s complicated. “The term pan-coronavirus vaccine needs an asterisk next to it,” Dr. Stuart Ray, vice chair of medicine for data integrity and analytics at Johns Hopkins’ Department of Medicine, told Fortune.
11th Jul 2022 - Fortune

CEPI provides $30m to advance novel coronavirus vaccine

The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with a consortium of research and technological institutions to fund the development of a novel vaccine to provide protection against COVID-19, as well other SARS-like Betacoronaviruses.
11th Jul 2022 - European Pharmaceutical Review

Hologic Announces Two New Respiratory Assays for the Detection of COVID-19, Flu A, Flu B and RSV

Hologic, Inc. announced that it is now offering its Panther Fusion ® SARS-CoV-2/Flu A/B/RSV assay and its Novodiag ® RESP-4 molecular diagnostic test for sale in the European Union in time for the northern hemisphere’s respiratory viral season. Both assays detect and differentiate four of the most prevalent respiratory viruses that can present with similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), influenza B (Flu B) and respiratory syncytial virus (RSV). The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a high-performance cartridge-based assay that runs on the fully automated high-throughput Panther Fusion system. The test uses nasopharyngeal swab samples.
11th Jul 2022 - The Associated Press

Study reveals sex-based differences in the clinical outcomes of COVID-19 in the US

In a recent study posted to the Research Square* preprint server, researchers investigated sex-based differences among coronavirus disease 2019 (COVID-19) patients in the United States (US). Studies have reported greater severity and fatality associated with COVID-19 among men compared to women across the globe; however, the mechanisms for sex-based differences in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are not clear. Previous research observations indicate that researchers must consider the patients’ sex as an important variable for COVID-19 data interpretation.
11th Jul 2022 - News-Medical.Net

BioNTech, Pfizer ask EU to authorize 3-dose COVID-19 vaccine for kids over 6 months

BioNTech and Pfizer Friday announced they had submitted data to the European Medicines Agency backing their three-dose COVID-19 vaccine for children aged 6 months to less than 5 years. The announcement follows the U.S. Food and Drug Administration granting emergency use authorization for the same schedule in its youngest kids on June 17. The three-dose regimen includes a much lower dose than what's given to adults. BioNTech and Pfizer say that the data from the trial, which enrolled over 10,000 children, indicates the three doses in young children elicited a strong immune response and has a favorable safety profile. Adverse reactions were generally less frequent in this age group compared to children aged between 5 and 12. As such, the companies want the EU to expand its conditional marketing authorization to include the youngest children.
11th Jul 2022 - POLITICO Europe

ECDC and EMA update recommendations on additional booster doses of COVID-19 vaccines

The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) are recommending that second booster doses of COVID-19 vaccines be considered for people between 60 and 79 years old and people with medical conditions putting them at high risk of severe disease.
11th Jul 2022 - ECDC.Europa.eu


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Pfizer, BioNTech Get Full FDA Approval for Covid Vaccine for Teens

Pfizer Inc. and BioNTech SE gained full US regulatory approval for their Covid-19 vaccine for teens 12 to 15 years old, a milestone that will allow the companies to continue to market it to adolescents after the pandemic. The vaccine partners earlier got formal approval for their Covid vaccine for teens 16 and older. In a statement on Friday, the companies said the US Food and Drug Administration approved their supplemental application to extend that approval to younger adolescents. The shot first went into play when it received emergency use authorization, a temporary clearance for use during the pandemic, for the age group. For full approval, the companies submitted additional information to the FDA, including six months of follow-up data after the two-dose regimen was complete in recipients.
10th Jul 2022 - Bloomberg

South Africa’s Afrigen to collaborate with US researchers on mRNA vaccines

South African biotech company Afrigen will collaborate with researchers from the US National Institutes of Health on the development of the next generation of mRNA vaccines and drugs as part of an attempt to expand global access to innovative medicines.
8th Jul 2022 - The Financial Times

Covid-19: FDA authorises pharmacists to prescribe Paxlovid

The US Food and Drug Administration (FDA) has authorised licensed pharmacists to prescribe Pfizer’s oral antiviral drug Paxlovid (nirmatrelvir and ritonavir) to eligible patients who have tested positive for covid-19, subject to some limitations. The FDA’s action on 6 July, a revision of the emergency use authorisation, will make the drug more widely available to people with covid-19, particularly in rural and poor areas. About 90% of the US population lives within five miles of a pharmacy, according to the American Pharmacists Association. Until now, only doctors, nurses, and physician assistants could prescribe Paxlovid. The drug is approved for treatment of mild to moderate covid-19 in adults and children aged 12 or older who weigh at least 40 kg and are at high risk for progression to severe covid-19, including hospital admission or death. Those who report a positive home test on either a rapid antigen diagnostic test or a polymerase chain reaction test are eligible for Paxlovid without further testing.
8th Jul 2022 - The BMJ

South Africa's Afrigen partners with U.S. on mRNA vaccine research

South Africa's Afrigen Biologics Limited said on Friday that it will collaborate with U.S. government researchers to develop mRNA vaccines and therapeutics. The agreement will enable the sharing of scientific expertise, technical skills and materials with the U.S. National Institutes of Health (NIH) to help Afrigen produce mRNA vaccines against COVID-19 and other diseases, said the Cape Town-based biotech start-up.
8th Jul 2022 - Reuters

EU drugs regulator open to COVID boosters that target older Omicron offshoots

The European Medicines Agency (EMA) is open to using next generation COVID-19 vaccines that target older offshoots of the Omicron variant this fall, an official said on Thursday, amid a rise in cases due to new Omicron subvariants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, vaccine effectiveness has taken a hit as the virus has evolved. The EMA expects new COVID vaccine boosters to be approved by September.
8th Jul 2022 - Reuters


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'All-in-one' coronavirus vaccine gets backing from CEPI

A new type of vaccine - which could provide broad protection against a variety of SARS-like betacoronaviruses, including SARS-CoV-2 variants - has received backing of up to $30m from CEPI.
7th Jul 2022 - BioPharma-Reporter.com

COVID-19 vaccination with bacterial peptide conjugated to receptor-binding domain elicits potent immune response

In a recent study published in the iScience journal, researchers assessed the efficiency of immunization with a bacterial peptide conjugated to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain against SARS-CoV-2 infection. Overall, the study findings showed that the CPD-RBD vaccination elicited a potent immune response and also protected against the severe symptoms associated with COVID-19.
7th Jul 2022 - News-Medical.Net

Brii Bio introduces Covid-19 combination therapy in China

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The company developed these antibodies in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.
7th Jul 2022 - Pharmaceutical Technology

Exothera to support process development of Turkish company's COVID-19 vaccine

Turkey based Vaccizone has chosen Belgian CDMO, Exothera, to fast-track process development of its COVID-19 vaccine for European clinical trials.
7th Jul 2022 - BioPharma-Reporter.com

COVID-19 and brain damage explained

The authors suggested that antibody-triggered cytotoxicity targeting the endothelial cells probably led to neuroinflammation, vascular leakage, platelet aggregation, and neuronal damage. Overall, the study findings illustrated that immune complexes accompanying complement activation damaging the microvasculature were the primary cause of blood-brain barrier collapse, microthromboses, perivascular inflammation, and neuronal damage in SARS-CoV-2 patients. The authors proposed that these events largely influenced the neurological symptoms found in acute COVID-19 and probably in long-COVID. Importantly, the current findings indicated the need for therapeutic modalities targeting the development of the immune complex.
7th Jul 2022 - News-Medical.Net

Africa CDC says it has signed MOU with Pfizer for COVID pill

Africa's top public health body said on Thursday it had signed a memorandum of understanding with Pfizer for countries on the continent to receive supplies of the Paxlovid pill to treat COVID-19. Data from a mid-to-late stage study in November last year showed the antiviral medication was nearly 90% effective in preventing hospitalisations and deaths compared to a placebo, in adults at high risk of severe illness.
7th Jul 2022 - Reuters

Wastewater study technique finds virus variants sooner; many patients are using meds affected by Paxlovid

With just a very small amount of raw sewage and a new analysis technique, researchers can determine the genetic mixture of SARS-CoV-2 variants in the community and detect new variants up to 14 days before they start showing up on patients' nasal swabs, according to a new report. Tests of a new method for wastewater genomic surveillance at the University of California, San Diego campus from November 2020 to September 2021 detected the Epsilon, Alpha and Delta variants "earlier and more consistently than clinical samples, and identified multiple instances of virus spread" that were not detected with traditional monitoring, researchers reported on Thursday in Nature.
7th Jul 2022 - Reuters

New Covid variants threaten China’s mRNA vaccine hopes

China is making progress in efforts to develop a homegrown messenger RNA Covid-19 vaccine, but experts warn that it risks being outpaced by rapid mutations of the Omicron coronavirus variant. Beijing’s refusal to approve foreign jabs, and the limited effectiveness of the more traditional inactivated vaccines available from domestic companies, mean an mRNA vaccine is widely seen as essential to any shift away from President Xi Jinping’s economically costly zero-Covid policy.
7th Jul 2022 - Financial Times


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Study: COVID would have killed 58% more Americans without vaccines

A new study estimates that COVID-19 vaccinations averted 58% of U.S. deaths that could have occurred in a hypothetical scenario in which no inoculations existed. Published Wednesday in JAMA Network Open, the modeling study concludes that COVID-19 vaccinations prevented 27 million infections, 1.6 million hospitalizations and 235,000 deaths among U.S. adults from December 2020 to September 2021. However, the study cautions that it relied on “incomplete national data” from multiple health records due to the lack of a national database and the “limitations of current methods” for measuring vaccine effectiveness.
6th Jul 2022 - Washington Times

EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in June this year.
6th Jul 2022 - Pharmaceutical Technology

COVID in California: Reinfection heightens risk of other health problems, study finds

A new type of vaccine protects against a variety of betacoronaviruses including the one that caused the COVID-19 pandemic and COVID’s variants, in mice and monkeys, a Caltech study found. Betacoronaviruses are a subset of coronaviruses that infect humans and animals. The study, published in the journal Science on Tuesday, from researchers in the laboratory of Caltech’s Pamela Bjorkman, professor of biology and bioengineering, found that the new vaccine is broadly protective. It works by presenting the immune system with spike protein pieces from SARS-CoV-2 and seven other SARS-like betacoronaviruses, attached to a protein nanoparticle structure, to induce production of cross-reactive antibodies, Caltech said.
6th Jul 2022 - San Francisco Chronicle

COVID-19 vaccination activates antibodies targeting parts of virus spike protein shared between coronaviruses

"Our theory is that there is actually memory from previous common cold coronavirus encounters, and when you get the vaccine for SARS-CoV-2, the vaccine reawakens some of those memories. Then you see this early response which is basically just a rapid memory response to what you've already seen," Altin said. "With time, the immune system can reshape those responses more in the direction of the pandemic virus."
6th Jul 2022 - Medical Xpress

Research highlights importance of designing effective COVID vaccine allocation strategies

In a recent study posted to the medRxiv* pre-print server, researchers at the University of Melbourne used a modified Susceptible, Exposed, Infectious, and Recovered (SEIR) mathematical model to examine the impact of different vaccine mechanisms and disease characteristics on a population comprised of individuals at high and low risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The study highlighted the significance of devising effective coronavirus disease 2019 (COVID-19) vaccine allocation strategies before the onset of the pandemic or the beginning of viral transmission at the community level.
6th Jul 2022 - News-Medical.Net

Two or 3 vaccine doses may cut risk of long COVID

An observational study of Italian healthcare workers infected with SARS-CoV-2 who didn't require hospitalization suggests a link between two or three doses of vaccine and a lower prevalence of long COVID. In the modeling study, published late last week in JAMA, researchers in Milan studied 2,560 workers at nine healthcare facilities from March 2020 to April 2022. All healthcare workers were mandated to receive three doses of the Pfizer/BioNTech mRNA COVID-19 vaccine in 2021. And all were screened for COVID-19 once a week or every 2 weeks and when they developed symptoms or were exposed to the virus.
6th Jul 2022 - CIDRAP

Estimates of long Covid are startlingly high. Here’s how to understand them

It’s important to remember that long Covid is an evolving umbrella term for an array of symptoms that vary in both number and degree. Some housebound people are assailed by brain fog that completely robs them of concentration, while others find memory aids help them get through their workdays. Some former athletes can’t complete a 6-minute walk test, while others can gradually return to activity if they monitor their heart rate. Long Covid clinics that adapt techniques from rehabilitation medicine see people eventually get better. In a world transitioning away from bustling downtowns to hybrid work-from-home status, we may not see who’s missing.
6th Jul 2022 - STAT News

Pharmacists Can Prescribe Pfizer's Covid Pill Under FDA Order

Pharmacists will be permitted to prescribe Pfizer Inc.’s Paxlovid under a move by US regulators aimed at providing prompt access to the widely used Covid treatment. State-licensed pharmacists can prescribe Paxlovid to eligible patients, subject to certain limitations to assure appropriate treatment, the Food and Drug Administration said Wednesday in a statement. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients,” Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, said in the statement.
6th Jul 2022 - Bloomberg


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The Health Risks of Getting Covid-19 a Second (or Third) Time

Covid-19 reinfections can bring some new risks of serious medical problems, hospitalization and death, a new study has found. Protection provided by vaccines and prior infection has greatly improved Covid outcomes since the pandemic’s early days, and reinfections are typically less severe than initial ones. Yet each new infection carries a risk of medical problems, including hospitalization, death and long Covid, according to preliminary data from a study of patients in the Veterans Affairs health system. This is a timely finding, doctors say, as more-infectious Omicron subvariants BA.4 and BA.5 proliferate and are expected to make reinfections more common.
5th Jul 2022 - The Wall Street Journal

Health Ministry approves COVID-19 vaccine for infants

Health Ministry Director General Professor Nachman Ash has approved the administration of Moderna's Pfizer-BioNTech's COVID-19 vaccines for infants and children ages six months to five years. Though the approval applies to all children in the above age group, the Health Ministry has not issued a general recommendation for the vaccine. The vaccines were approved last month by the US Food and Drug Administration (FDA), and later the same month by the Israeli Health Ministry's Staff for the Management of Pandemics.
5th Jul 2022 - Arutz Sheva

Oxford University Takes Aim at Future Pandemics After Covid Vaccine

The University of Oxford, one of the first to cross the finish line with a Covid-19 vaccine, is shifting its focus to health threats that could trigger the next pandemic. Oxford’s Pandemic Sciences Institute, launched Tuesday, aims to reduce the risks posed by infectious diseases by improving data collection, strengthening surveillance and helping to create vaccines and other countermeasures. Oxford said the organization will seek to learn from the response to Covid and take advantage of the university’s research and global partnerships. But it will have to bring in additional funds to carry out its mission.
5th Jul 2022 - Bloomberg

Spectacular success of mRNA COVID-19 vaccines just a glimpse of their full potential

The "spectacular" success of mRNA (messenger ribonucleic acid) vaccine technology against SARS-CoV-2 provides "just a glimpse of their full potential", according to the authors of a Perspective published by the Medical Journal of Australia today. Asymptomatic individuals constitute 16–38% of the SARS-CoV-2 infected population which increases the difficulty of identifying infected individuals. The lack of convenient and sensitive tests to detect the virus in all individuals is continuing to limit global response to the pandemic. Predominantly, SARS-CoV-2 is detected through RT-PCR (real-time reverse transcription polymerase chain reaction) on swab samples collected from the nose and throat. However, these tests require long detection times, high costs, specialized equipment and medical personnel, and are not feasible in areas where resources are limited.
5th Jul 2022 - Medical Xpress

Skin Patch Test Detects COVID-19 in Under Three Minutes

A rapid and reliable skin-patch test can now detect the COVID-19 virus, and potentially other infectious agents in under three minutes, without the need to draw blood. This convenience overcomes a current challenge in identifying infected individuals who are averse to blood tests and could help restrict the spread of the pandemic. The details of the new test were published on July 1, 2022, in an article in the journal Scientific Reports titled, “Anti‑SARS‑CoV‑2 IgM/IgG antibodies detection using a patch sensor containing porous microneedles and a paper‑based immunoassay.”
5th Jul 2022 - Genetic Engineering & Biotechnology News

The Health Risks of Getting Covid-19 a Second (or Third) Time

Covid-19 reinfections can bring some new risks of serious medical problems, hospitalization and death, a new study has found. Protection provided by vaccines and prior infection has greatly improved Covid outcomes since the pandemic’s early days, and reinfections are typically less severe than initial ones. Yet each new infection carries a risk of medical problems, including hospitalization, death and long Covid, according to preliminary data from a study of patients in the Veterans Affairs health system. This is a timely finding, doctors say, as more-infectious Omicron subvariants BA.4 and BA.5 proliferate and are expected to make reinfections more common.
5th Jul 2022 - The Wall Street Journal

CureVac files patent lawsuit in Germany against BioNTech

CureVac has filed a patent lawsuit in Germany against BioNTech over its use of mRNA technology, marking one of the first known cases of a company going to court amid the fierce competition to develop a vaccine against the coronavirus. The German-based biotech company is seeking "fair compensation" from BioNTech and two subsidiaries for infringement of its intellectual property rights, it said on Tuesday.
5th Jul 2022 - Reuters

New Covid subvariants BA.4 and BA.5 are the most contagious yet – and driving Australia’s third Omicron wave

Australia is heading for its third Omicron wave in the coming weeks, as BA.4 and BA.5 become the dominant Covid strains. BA.4 and BA.5 are more infectious than previous Covid variants and subvariants, and are better able to evade immunity from vaccines and previous infections. So we’re likely to see a rise in case numbers. So what are BA.4 and BA.5? And what can we expect in this next phase of the pandemic?
5th Jul 2022 - The Guardian

BA.5 Subvariant Drives Majority of Recent Covid-19 Cases

The highly contagious Omicron BA.5 subvariant has taken over as the dominant version of the virus causing new Covid-19 cases in the U.S., the latest federal data show. BA.5 represented nearly 54% of U.S. cases in the week ended July 2, the Centers for Disease Control and Prevention estimated Tuesday. It surpassed BA.2.12.1, the version of Omicron partly responsible for a persistent springtime surge in cases, which is now estimated to represent closer to one in four cases. Another version known as BA.4, which is closely related to BA.5, and also ramped up recently, represents nearly 17% of cases, the CDC estimates.
5th Jul 2022 - The Wall Street Journal


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Long COVID: 'Viral reservoir' of spike protein may explain long-term symptoms

Researchers investigated the antigens of SARS-CoV-2—the virus that causes COVID-19—present in blood plasma samples collected from individuals with long COVID and typical COVID-19 infection. They found that one particular SARS-CoV-2 antigen—the spike protein—was present in the blood of a majority of long COVID patients, up to a year after they were first diagnosed with COVID-19. In patients with typical COVID-19 infection, however, the spike protein was not detected. This finding provides evidence for the hypothesis that SARS-CoV-2 can persist in the body through viral reservoirs, where it continues to release spike protein and trigger inflammation.
4th Jul 2022 - Medical News Today

Hong Kong's Lee Sees No Immediate Need for Mass Covid Testing

Hong Kong’s new Chief Executive John Lee said there is no immediate need for a universal compulsory Covid testing campaign in the city but stressed that there needs to be a reduction in the number of daily infections, which are at the highest level since April. Lee, appearing on a program broadcast by TVB on Sunday, shed more light on his Covid agenda for the first time since being sworn in as chief executive on Friday by Chinese President Xi Jinping, who was also in the city to celebrate the 25th anniversary of its return to Chinese rule. Hong Kong should carry out more laboratory nucleic acid testing for Covid because it’s a reliable way to detect infections, but this would not expand into a universal compulsory testing campaign for now,
4th Jul 2022 - Bloomberg

Covid Shots Are Coming. Will They Be Too Late?

Roseann Renouf, 77, has grown tired of the current generation of coronavirus shots. Having “never been one for a lot of vaccination,” she decided to forgo the latest round of boosters after watching vaccinated friends contract Covid-19, even though the doses offer a critical extra layer of protection. “It’s just taking another same booster,” Ms. Renouf, a retired nurse anesthetist from Fort Worth, said. “They haven’t done anything different with them to cover new variants.” But her gripe about the Covid vaccines may soon be settled. American regulators committed last week to updating the 2020 vaccine recipes for this fall’s booster campaign with new formulas meant to defend against the ultra-contagious Omicron subvariants, offering Ms. Renouf and other holdouts a fresh reason to change their minds.
4th Jul 2022 - The New York Times

Oxford Biomedica, AstraZeneca enter new deal for Covid-19 vaccine

Oxford Biomedica has entered a new three-year Master Services & Development Agreement to potentially manufacture AstraZeneca UK’s Covid-19 vaccines in the future. The latest deal is an extension of an original Master Supply and Development Agreement signed by the parties in September 2020. Under the initial deal, the production of Covid-19 vaccines at the Oxbox facility of Oxford Biomedica is anticipated to conclude in the last quarter of this year. As per this agreement, AstraZeneca had agreed to make an upfront payment of $18.1m (£15m) to Oxford Biomedica as a capacity reservation fee.
4th Jul 2022 - Pharmaceutical Technology

Paxlovid remains effective in those vaccinated against COVID-19

Israeli researchers have found that paxlovid use in those at risk of COVID-19 progression remains effective even in fully vaccinated patients. The effectiveness of the anti-viral drug paxlovid in preventing the progression of COVID-19 remains even in those who have been adequately vaccinated against the virus according to the results of a real-world study by Israeli researchers. Paxlovid consists of nirmatrelivir, a protease inhibitor against COVID-19 and ritonavir, which reduces the in vivo metabolism of nirmatrelivir. The published data for the drug (the EPIC-HR trial) suggested that treatment of symptomatic COVID-19 in patients at risk of progression to severe disease, results in an 89% lower risk compared to placebo. Nevertheless, the study was undertaken before omicron became the main circulating variant and therefore the generalisability of the study’s findings are potentially limited.
4th Jul 2022 - Hospital Healthcare Europe

Omicron-specific COVID shots could increase protection as boosters, European Medicines Agency says

Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday. Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
4th Jul 2022 - Reuters

'Two doses are no longer enough': Canadians required to get COVID shot every nine months

Canadians will be required to get a booster shot every nine months for the foreseeable future, Health Minister Jean-Yves Duclos told reporters. So if you thought you were fully vaccinated, think again. Duclos said that the previous definitions of “fully vaccinated” makes no sense, explaining that it’s more important that shots are “up to date” and whether or not a person has “received a vaccination in the last nine months.” He added, “We will never be fully vaccinated against COVID-19,” according to Blacklock’s Reporter. Duclos was asked if he was preparing Canadians for the return of vaccine mandates in the fall, he reportedly replied, “We must continue to fight against COVID.”
4th Jul 2022 - Toronto Sun

COVID vaccines prevented poor outcomes in people of all sizes

COVID-19 vaccination protected people of all body sizes from hospitalization and death—although vaccinated people with a low or high body mass index (BMI) were at greater risk, according to a study of adults in England published yesterday in The Lancet Diabetes & Endocrinology. University of Oxford researchers led the study, which involved 9,171,524 adult primary care patients in England with available body mass index (BMI) data from Dec 8, 2020 (when the COVID-19 vaccine first became available in the United Kingdom), to Nov 17, 2021. Average patient age was 52 years, and average BMI was 26.7 kilograms per meter squared (kg/m2) (overweight).
1st Jul 2022 - CIDRAP

Oxford Biomedica signs up for 3 more years of making AstraZeneca COVID shots⁠—on an 'as needed basis'

There was a time—not so long ago—when COVID-19 vaccine manufacturers couldn’t produce doses fast enough. But that was then, and this is now: Friday, when Oxford Biomedica revealed an extension of its contract with AstraZeneca through 2025, the deal was to make shots on an “as needed basis,” the company said. This comes just nine months after Oxford announced a 50 million pound sterling ($68 million) investment from the over-strapped Serum Institute of India to increase its ability to manufacture COVID vaccines for AZ at its Oxbox facility.
1st Jul 2022 - FiercePharma


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

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Study determines ideal COVID19 vaccine type, timing during pregnancy

Since the COVID-19 vaccine rollout, data has indicated that inoculation during pregnancy can help to protect both the mother and baby. New research collaboratively conducted at Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH), published in the peer-reviewed Nature Communications, looked further into the extent of this protection by examining which vaccine is most effective, and when.
1st Jul 2022 - The Jerusalem Post

COVID-19 vaccination for children aged 5–11 years

When considering risks, post-implementation studies have found BNT162b2 to be safe in children aged 5–11 years.17 Importantly, the small but serious risk of vaccine-induced myocarditis appears to be much lower in children aged 5–11 years (reporting rate of 2·2 cases per million doses) than in adolescents or young adults.17 Implementation of a large-scale immunisation programme, however, comes with both financial and opportunity costs—for example, diversion of health-care staff and resources could potentially affect the provision of other crucial health-care services, such as routine childhood immunisation programmes. Clinicians and parents must balance the relatively small risks of severe disease outcomes with the relatively small risks that accompany vaccination in children aged 5–11 years. Although many countries continue to actively recommend COVID-19 vaccination for children aged 5–11 years, some countries, such as Sweden, have advised against vaccinating healthy 5–11 year-olds,18 whereas others, such as Norway, have made the vaccine available should parents wish to vaccinate their children.19 With the US Food and Drug Administration authorisation of use of COVID-19 vaccines in children younger than 5 years,20 the same dilemmas are likely to resurface, although with even more marginal risk–benefit ratios. In particular, considering that the global population has been living through the pandemic for more than 2 years and has been exposed to multiple waves of different SARS-CoV-2 variants, governments, policy makers, and clinicians need to urgently address the added value of vaccination—be it primary or boosters—for protection against severe disease outcomes in children who have already been infected by the virus. Above all, public messaging of the risks and benefits of vaccinating children against COVID-19 needs to be clear to encourage public confidence in vaccines and trust in those advocating for vaccination to prevent other, more serious diseases.
1st Jul 2022 - The Lancet

Pfizer seeks approval from US FDA for Covid-19 treatment

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally. Due to the oral form, the therapy can be prescribed in the early infection stage to avert severe illness. Paxlovid received emergency use authorization to treat mild-to-moderate Covid-19 in adults and paediatric patients aged 12 years and above who are at increased disease progression risk.
1st Jul 2022 - Pharmaceutical Technology

Two-week break from methotrexate may boost Covid-19 vaccine effect

A two-week break from taking methotrexate after a Covid-19 booster vaccine can help improve its effectiveness, a UK trial has suggested. Analysis of immune responses in 127 participants who were randomly allocated to suspend methotrexate use for two weeks and 127 to continue using it as usual, showed such a difference that researchers stopped the trial early. At four weeks and 12 weeks after the Covid-19 jab, participants’ spike-antibody levels were more than two-fold higher in the paused methotrexate group compared with those who continued to take the drug. Reporting in The Lancet Respiratory Medicine, the researcher also found a worsening of disease control at week four in those who had stopped taking methotrexate but that it had normalised by week 12. Overall, there was no impact on quality of life or general health, suggesting the approach could be useful for more than a million people in the UK who take the immune-suppressing drug for inflammatory conditions.
1st Jul 2022 - Pulse Today

Modified mRNA COVID shots could increase protection as boosters - EMA

Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday. Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
1st Jul 2022 - Reuters

Oxford Biomedica signs new deal to make AstraZeneca COVID shot

Britain's Oxford Biomedica said on Friday it had signed a new three-year agreement to potentially make AstraZeneca's COVID-19 vaccine beyond 2022, but no volumes were defined in an indication of waning demand for the shot. Cell and gene therapy firm Oxford Biomedica said in April that it had manufactured more than 100 million doses of AstraZeneca's vaccine since their partnership began in September 2020. Commitments under the deal are scheduled to end this year.
1st Jul 2022 - Reuters

US FDA wants COVID boosters targeting Omicron BA.4, BA.5 subvariants

The U.S. Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants of the coronavirus. If authorized, the changes would mark the first major retooling of COVID vaccines, but also could slow their rollout as the FDA has recommended a design somewhat different from what the companies had already tested and started producing.
1st Jul 2022 - Reuters

Omicron-specific COVID shots could increase protection as boosters - EMA

Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday. Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants. While the existing coronavirus vaccines continue to provide good protection against hospitalisation and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
1st Jul 2022 - Reuters

Oxford Biomedica (LON:OXB) Signs Covid Vaccine Deal With AstraZeneca

Oxford Biomedica Plc has signed a three-year agreement with AstraZeneca Plc to manufacture the UK drug giant’s Covid-19 vaccine on an as-needed basis. The agreement is an extension of the original supply and development agreement signed between the two companies in September 2020, as the coronavirus swept around the world, according to a statement Friday. Oxford Biomedica stock was up more than 3% in early trading in London.
1st Jul 2022 - Bloomberg


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

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Fair Pharma Scorecard shows industry has a long way to go for COVID-19 products

How has the pharma industry weighed human rights during its marketing of COVID-19 drugs and vaccines? That’s what the Pharmaceutical Accountability Foundation (PAF) sought to answer, and the results might not be what the industry wants to hear. For its Fair Pharma Scorecard project, PAF ranked 26 companies involved in selling COVID-19 drugs, vaccine and diagnostics based on their compliance with 19 human rights principles. Not one company complied with all the criteria, and most "still need to take big steps" to make their products accessible and affordable, PAF said. In general, PAF noticed a weariness toward knowledge sharing, iffy transparency levels and differences between various products at the same companies. For example, Pfizer's compliance with the criteria scored at 65% for its oral antiviral Paxlovid and 50% for its vaccine.
30th Jun 2022 - FiercePharma

Fauci says he believes Paxlovid kept him out of the hospital, even though he tested positive again.

“Paxlovid did what it was supposed to do,” Dr. Fauci, 81, said in an interview, saying that he believed that the treatment, made by Pfizer, kept him out of the hospital when he first tested positive for the virus on June 15. He added that he thought the drug also reduced the severity of his initial symptoms. One thing Paxlovid could not do was keep Dr. Fauci from missing his daughter’s wedding. It went on without him in New Orleans two Saturdays ago, when he was sidelined with his initial infection. He participated remotely. Dr. Fauci has been vaccinated against Covid and has received two booster doses. His experience with Paxlovid adds to a growing body of anecdotal evidence about patients whose Covid symptoms improved after they took Paxlovid, and who even tested negative, only to have symptoms occur again a few days later. That is exactly what happened to him, Dr. Fauci said; he recently tested positive again after three days of negative tests.
30th Jun 2022 - The New York Times

Pfizer Seeks FDA’s Full Approval for Paxlovid Covid-19 Pill

Pfizer Inc. has asked the Food and Drug Administration to grant full approval of its Covid-19 antiviral pill, a step toward allowing the drugmaker to sell the drug commercially. Pfizer said Thursday that it had filed the submission. The FDA typically has 60 days to accept the application and up to 10 months to conduct a review before issuing a decision. To date, Pfizer has been selling the drug, called Paxlovid, to the federal government under an authorization for emergency use. The federal government has then been directing the pills’ distribution.
30th Jun 2022 - The Wall Street Journal

A 14-year-old tiger died after contracting Covid-19 in an Ohio zoo, officials say

A tiger at an Ohio zoo died of health complications caused by Covid-19, officials said Wednesday. The 14-year-old Amur tiger, Jupiter, died Sunday after developing pneumonia caused by the virus, the Columbus Zoo and Aquarium said in a statement. Jupiter was undergoing long-term treatment for chronic underlying illnesses, which made him more susceptible to the virus, the zoo said. Jupiter's care team reported last week that he had been "acting ill." He wasn't interested in eating or interacting with his keepers and was reluctant to move or stand, according to the statement. After Jupiter was anesthetized for examination, results suggested he may have been suffering from an infection, and treatment began.
30th Jun 2022 - CNN

Covid-19: Canada outperformed comparable nations in pandemic response, study reports

Canada performed better than the majority of G10 countries in its response to the first two years of the covid-19 pandemic, a study has concluded. A paper published in the Canadian Medical Association Journal concluded that Canadians were better vaccinated than comparable western countries, with fewer infections, fewer covid deaths, and lower mortality from all causes. Researchers from the University of Toronto, some of whom are members of Ontario’s covid-19 science advisory board, linked the country’s lower death rate to the persistence of its social restrictions and the relative lack of antivaccine sentiment. The study compared responses from the 11 countries in the G10, comprising Canada, Belgium, France, Germany, Italy, Japan, the Netherlands, Sweden, Switzerland, the UK, and the US. Japan was an extreme outlier, with by far the fewest deaths and infections despite having the oldest population and imposing the mildest restrictions.
30th Jun 2022 - The BMJ

S.Korea authorises AstraZeneca COVID therapy Evusheld for vulnerable people

South Korea on Thursday authorised AstraZeneca PLC's antibody-based therapy for preventing COVID-19 infection in people with a poor immune response, increasing its options as it works to ease the pandemic burden on the healthcare system. The Ministry of Food and Drug Safety granted emergency use authorisation for 20,000 doses of Evusheld for individuals aged 12 years and older who have not been exposed to the coronavirus.
30th Jun 2022 - Reuters

Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid

Pfizer Inc said on Thursday it is seeking full U.S. approval for its oral COVID-19 antiviral treatment Paxlovid, which is currently available under an emergency use authorization (EUA). Pfizer said it submitted a New Drug Application for Paxlovid to the Food and Drug Administration for the treatment of COVID-19 in vaccinated and unvaccinated people at high risk of progression to severe illness.
30th Jun 2022 - Reuters

NYC to Offer Pfizer's Covid Drug at Mobile Test-to-Treat Sites

New York City will start offering Pfizer Inc.’s Covid antiviral Paxlovid at “first of its kind” mobile test-to-treat sites across the city, providing immediate treatment for those who test positive for the virus. Initially, mobile sites will be stationed outside of pharmacies in Inwood, South Ozone Park and the East Bronx, and will expand to 30 locations by the end of July, Manhattan’s Borough President Mark Levine said on Twitter Thursday. People who test positive for Covid and qualify for Paxlovid will be able to get a prescription on-the-spot, which they can take to a nearby pharmacy to pick up the drug. By the end of the summer, officials plan to bypass pharmacies entirely, offering Paxlovid directly through the mobile sites.
30th Jun 2022 - Bloomberg

Maternal deaths climbed 33% during COVID-19

Maternal deaths in the first months of the COVID-19 pandemic increased 33%—and even higher in Black and Hispanic women—according to data from the National Center for Health Statistics (NCHS) published yesterday in a study in JAMA Network Open. That rate compares with an overall 22% COVID-related excess death rate during the study period, according to two researchers from the University of Maryland (UMD) and Boston University (BU), who conducted the study. They defined maternal mortality as deaths during pregnancy or just after birth.
29th Jun 2022 - CIDRAP

COVID-19 tracker: Pfizer seeks full approval for Paxlovid

After running six months on an emergency use authorization for Paxlovid, Pfizer is now seeking a full FDA approval for the COVID antiviral in patients who are at high risk for progression to severe illness regardless of their vaccination status. When taken within five days of symptom onset, Paxlovid cut the risk of hospitalization or death from any cause by 86% in non-hospitalized, high-risk patients, according to final results from the phase 2/3 EPIC-HR study. Pfizer's application package also includes data from the EPIC-SR study, which didn't hit its goal in vaccinated patients with, and unvaccinated patients without, risk factors for severe COVID.
29th Jun 2022 - FiercePharma

FDA: Don’t rush a move to change the Covid-19 vaccine composition

On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2 to approve the use later this year of Covid-19 vaccines based on an Omicron variant sequence. One of us (P.A.O.) was among those voting “no.” It is possible these vaccines will be two-component designs that also include the current version. Will Americans soon be better protected against Covid-19? The Covid-19 vaccines currently authorized for use in the U.S. are all based on the sequence of the original SARS-CoV-2 virus, which was obtained early in 2020. The virus has evolved over the past 30 months, creating variants that are either more infectious, or harder to counter by vaccination, or both
29th Jun 2022 - STAT News


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

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Doctors treat first UK patient in Covid ‘super donor’ blood trial

Doctors have treated the first UK patient in a reopened clinical trial that will explore whether blood plasma from “super donors” can help fight Covid in those with weakened immune systems. Super donors produce exceptionally high levels of antibodies after infection and vaccination, and there are hopes that transfusions of their blood plasma can wipe out the virus in people whose own immune systems are compromised. While two landmark trials known as Recovery and Remap-Cap found that convalescent plasma from people who recovered from Covid did not benefit other patients, a closer look at the Remap-Cap data showed that plasma with the highest levels of antibodies might help the immunosuppressed. The findings prompted doctors to reopen the plasma arm of the Remap-Cap trial to investigate specifically whether donated plasma with extremely high levels of antibodies can save the lives of people with weakened immune systems and reduce the amount of time they spend in intensive care.
30th Jun 2022 - The Guardian

How the UK’s rising Covid cases compare to other countries

The UK is facing its fifth wave of Covid infections, experts have warned, as cases hit 1.8m in the latest weekly figures, a 23 per cent climb week-on-week. More worryingly, hospital admissions have increased 31 per cent, climbing at a higher rate than the last Omicron revival back in March.
30th Jun 2022 - The Independent

Coronavirus vaccines should be updated for fall, FDA advisers say

It’s time to update coronavirus vaccines to better match the variants currently driving the pandemic, outside experts told the Food and Drug Administration on Tuesday. The independent scientists and physicians endorsed an updated omicron vaccine by a 19-2 vote. Despite the overwhelming agreement that it is time to change the vaccine, many experts said they felt frustrated and hamstrung by the need to make a decision quickly to prepare for fall with limited data.
29th Jun 2022 - The Washington Post

BioNTech, Pfizer to start testing universal vaccine for coronaviruses

Germany's BioNTech, Pfizer's partner in COVID-19 vaccines, said the two companies would start tests on humans of next-generation shots that protect against a wide variety of coronaviruses in the second half of the year. Their experimental work on shots that go beyond the current approach include T-cell-enhancing shots, designed to primarily protect against severe disease if the virus becomes more dangerous, and pan-coronavirus shots that protect against the broader family of viruses and its mutations.
29th Jun 2022 - Reuters

S.Korea approves first domestically developed COVID vaccine

South Korea approved its first domestically developed COVID-19 vaccine, manufactured by SK bioscience Co Ltd, for general public use following positive clinical data, authorities said on Wednesday. The SKYCovione vaccine was authorised for a two-dose regimen on people aged 18 or older, with shots given four weeks apart, according to the Ministry of Food and Drug Safety. In a phase III clinical trial of 4,037 adults, SKYCovione induced neutralizing antibody responses against the SARS-CoV-2 parental strain, SK bioscience said in a statement.
29th Jun 2022 - Reuters

U.S. FDA advisers recommend change to COVID vaccine composition for fall

Advisers to the U.S. Food and Drug Administration on Tuesday recommended a change in the design of COVID-19 booster shots this fall in order to combat more recently circulating variants of the coronavirus. The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-2 that the next wave of COVID booster shots should include a component that targets the Omicron variant of the coronavirus.
29th Jun 2022 - Reuters

Covid: Face masks brought back at Nottinghamshire hospital sites

Face masks have been reintroduced at some Nottinghamshire hospitals just two weeks after they were dropped. Mask policy had been relaxed in all but high-risk areas of Sherwood Forest Hospitals' three sites as part of a phased return to pre-pandemic policies. But a rise in covid cases among staff and patients at King's Mill, Newark and Mansfield Community hospitals has led to the decision being reversed. Bosses said they would keep face mask and visiting requirements under review.
29th Jun 2022 - BBC News

FDA advisers call for Omicron update for COVID boosters

The Food and Drug Administration (FDA) outside advisory committee today recommended that new booster shot versions include an Omicron variant component, as newer subvariants expand their footprint and the nation faces an uncertain fall and winter with the virus. In its weekly update today, the Centers for Disease Control and Prevention (CDC) said the proportion of BA.4 and BA.5 subvariants increased sharply last week, mainly due to BA.5.
28th Jun 2022 - CIDRAP


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

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Korea's First Home-Grown COVID-19 Vaccine To Speed Hub Ambitions

Only one last step remains before the approval of South Korea’s first home-grown COVID-19 vaccine as SK Bioscience’s SKYCovione (GBP510) receives positive assessments from review committees. Any nod, which could happen this week, would mark a milestone for the country's ambitions of becoming a global vaccine hub.
28th Jun 2022 - Pink Sheet

Rare heart-related side effects higher with Moderna COVID vaccine

Though both complications were rare, data from Ontario show higher rates of myocarditis and pericarditis with the Moderna COVID-19 vaccine than with the Pfizer-BioNTech vaccine, but the rates were lower for both vaccines if the spacing between receiving two doses was extended, according to a study late last week in JAMA Network Open. Myocarditis is an inflammation of the heart muscle, and pericarditis involves swelling of the thin membrane around the heart.
28th Jun 2022 - CIDRAP

Indias first indigenous mRNA vaccine likely to be available soon

Soon India may have its first indigenous mRNA vaccine that is stable at 2-8 degrees Celsius as the expert panel advising the Central Drugs Standards Control Organisation (CDSCO) has green-signalled Gennova Biopharma's mRNA vaccine candidate for Covid19. The Subject Expert Committee (SEC) has recommended granting the Emergency Use Authorisation (EUA) to the country's first mRNA-based Covid-19 vaccine in a meeting held on Friday, according to reports. Now, the Drugs Controller General of India (DCGI) will take a final call on granting the final approval.
28th Jun 2022 - Business Standard

COVID was twice as deadly in poorer countries

Early in the COVID-19 pandemic, the risk of dying from the disease was roughly twice as high for people living in lower-income countries as for those in rich nations, a study reports. The research, published in BMJ Global Health in May1, is one of a growing number of studies to reveal COVID-19’s massive burden in lower-income countries. Data from early in the pandemic suggested that death and infection rates in poor countries were relatively low compared with those in rich ones. But recent evidence paints a very different picture, says Madhukar Pai, an infectious- disease epidemiologist at McGill University in Montreal, Canada. “This paper is one among many that illustrate that the biggest impact of this pandemic has been on low- and middle-income countries,” says Pai.
28th Jun 2022 - Nature.com

In 1st year of pandemic, COVID vaccines saved 20M lives

Based on official data on COVID-19 deaths, the authors estimated that vaccinations prevented 14.4 million deaths in 185 countries and territories during the one-year study duration. Based on excess mortality estimates, they observed that vaccinations halved the potential global death toll and averted around 19.8 million deaths in a year. The latter represents the true extent of the first year of the pandemic, showing a global reduction of 63% in total deaths due to vaccination.
28th Jun 2022 - News-Medical.Net

Fast-evolving COVID variants complicate vaccine updates

As countries brace for another Omicron wave driven by the variants BA.4 and BA.5, calls to update COVID-19 vaccines are growing louder. Existing vaccines based on the version of the virus SARS-CoV-2 that emerged in Wuhan, China, in late 2019 are a poor match to current Omicron strains. As a result, the vaccines now offer only short-lived protection from infection — although they seem to be holding up against severe disease. This week, an advisory panel to the US Food and Drug Administration (FDA) will meet to discuss whether COVID-19 vaccines should be updated — and what the upgraded vaccines should look like.
28th Jun 2022 - Nature.com

EnGeneIC’s second generation COVID-19 vaccine protects against all variants

The world’s first COVID-19 vaccine to offer immunity against all variants is one step closer. Clinical trials have shown the novel vaccine works by stimulating a completely different immune pathway from other vaccines, producing “high affinity” antibodies that neutralise all COVID-19 variants. Australian Biopharma company EnGeneIC is currently conducting trials of its groundbreaking vaccine in Sydney and Melbourne. Thirty-two healthy participants received two doses, three weeks apart. Of those, 27 have passed the 28-day safety assessment with no side effects. Critically, they all have high affinity antibodies capable of neutralising all COVID-19 mutants, including Omicron.
28th Jun 2022 - The Associated Press

How do I know if I've had COVID-19, and what else can antibody blood tests tell us about past infection?

Antibody blood tests can tell you if you've had COVID-19, but there are some caveats. COVID-19 antibodies naturally dwindle over time, so if they turn up in your blood test, their levels can't tell you exactly how long ago you were infected — just that you were infected sometime in the past few months. "We think now [the test] is a useful marker of fairly recent infection, as opposed to whether you've ever been infected," Dr Machalek says.
28th Jun 2022 - ABC News

Majority of secondary school children have Covid-19 antibodies, says new data

Nearly all secondary school-age children have Covid-19 antibodies, according to new data. Data from the School Infection Survey, which was released on Monday, revealed that numbers of primary school parents who would be "unlikely" to vaccinate their children has increased. The news comes as levels of Covid continue to rise in the UK, with new cases likely due to variants of the Omicron strain. In the last week, an estimated 1.7million people are reported to have had the virus, up 23% from 1.4 million the previous week.
28th Jun 2022 - Daily Record

COVID-19 fattens up our body's cells to help fuel its viral takeover, study suggests

Researchers tried using weight-loss drugs and other fat-targeting compounds to try to stop the virus in cell culture. The new study comes as infections rose in all four UK nations, with about 1.7 million having the virus last week.
28th Jun 2022 - Sky News

Improving COVID-19 vaccine immunogenicity by interrupting methotrexate treatment

In summary, this important study shows that a 2-week interruption of methotrexate after booster COVID-19 vaccination results in increased immunogenicity compared with no interruption among patients with several immune-mediated inflammatory diseases. Although this finding adds to the evidence base to support interruption of methotrexate after vaccination, a shared decision process is needed to weigh the possible benefit of optimising protection from COVID-19 and the possible risk of underlying disease flare.
28th Jun 2022 - The Lancet

U.S. FDA will decide on redesigned COVID vaccines by early July

U.S. regulators plan to decide by early July whether to change the design of COVID-19 vaccines this fall in order to combat more recent variants of the coronavirus, with hopes of launching a booster campaign by October, a top Food and Drug Administration official said on Tuesday. "The better the match of the vaccines to the circulating strain we believe may correspond to improve vaccine effectiveness, and potentially to a better durability of protection," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said at a meeting of outside expert advisers to the agency.
28th Jun 2022 - Reuters

Are Updated Booster Shots Coming?

Tomorrow will be a big day for the future of U.S. coronavirus vaccines: A panel of independent advisers to the F.D.A. will recommend whether to update the existing vaccines to take aim at a version of the virus in the Omicron family. The advisory panel also will probably split between those who believe a fall booster will be broadly necessary and those who would limit additional shots to high-risk individuals. The policy may depend on funding and resources. “It’s very clear we’re not going to have enough vaccines for every adult who wants one,” said Dr. Ashish Jha, the White House coordinator for the pandemic response.
27th Jun 2022 - The New York Times

AstraZeneca launches first Evusheld DTC, but without full approval it comes with a different feel

AstraZeneca launched the first ever COVID drug DTC for its prevention antibody, Evusheld, and it’s one of the most unusual and unique commercials you will see this year. The ad, which is set up more as a public health announcement (though is heavily branded), has a very different feel from most traditional pharma DTCs. There are no bright colors or emotional beats. You won’t find someone roller skating around a park, for instance, or someone running with their dog. What you get instead is just one narrator, standing in a bland, empty, white office space, laying out informatively how Evusheld works, who it’s for and, instead of waiting for the end of the ad, explaining many of the potential side effects in the middle of the video.
24th Jun 2022 - FiercePharma


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

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Epstein-Barr may play a role in some long COVID; coronavirus can impair blood sugar processing by organs

Among 280 patients with SARS-CoV-2 infections, including 208 with long COVID, researchers found that at four months after diagnosis, fatigue and problems with thinking and reasoning were more common in study participants with immune cells in their blood showing signs of recent EBV reactivation. These signs of reactivation were not linked with other long COVID findings such as gastrointestinal or heart and lung problems, however. And EBV itself was not found in patients' blood, which suggests any reactivation likely is transient and happens during acute COVID-19, Dr. Timothy Henrich of the University of California, San Francisco and colleagues reported on medRxiv ahead of peer review.
28th Jun 2022 - Reuters

Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine

Pfizer and BioNTech have shared positive results from a phase 2/3 trial of two Omicron-adapted COVID-19 vaccine candidates. The data shows that a booster dose of both Omicron-adapted vaccines gave a considerably higher immune response against Omicron BA.1, compared to Pfizer/BioNTech’s current COVID-19 vaccine. The phase 2/3 trial involved 1,234 participants aged 56 and older. One month after receiving a booster dose, the Omicron-adapted monovalent candidates significantly increased protection against Omicron BA.1, showing a 13.5 and 19.6-fold increase above pre-booster dose levels. One vaccine is monovalent and the other is bivalent, made up from a combination of the Pfizer/BioNTech COVID-19 vaccine and a vaccine candidate designed to target the spike protein of the Omicron BA.1 variant.
27th Jun 2022 - PMLiVE

EMA recommends Novavax COVID vaccine for adolescents

EU Reporter publishes articles from a variety of outside sources which express a wide range of viewpoints. The positions taken in these articles are not necessarily those of EU Reporter.
27th Jun 2022 - EU Reporter

China's first mRNA vaccine is close — will that solve its COVID woes?

China is getting closer to approving its first mRNA vaccine to protect people against COVID-19. In a small clinical trial, the Chinese vaccine candidate triggered a stronger antibody response in vaccinated adults when given as a booster shot than did a jab containing inactivated SARS-CoV-2, the vaccine platform that the country has mostly relied on so far. The experimental jab, called ArCoV, is a strong candidate to become China’s first approved mRNA vaccine. But what it would mean for the government’s handling of the pandemic is hard to know, say researchers. A highly effective mRNA vaccine would reduce the chances of widespread serious infections that could overwhelm hospitals. However, it is unlikely to bring an end to the country’s strict ‘zero COVID’ strategy, which uses mass testing and lockdowns to quash all infections.
27th Jun 2022 - Nature.com

F.D.A. May Move Toward Updating Vaccines

A panel of independent experts advising the Food and Drug Administration is set to recommend on Tuesday whether to update existing Covid-19 vaccines to target a newer version of the coronavirus in a booster shot that Americans could get in the fall. The federal government is hoping to improve the vaccine to better boost people’s immunity before a likely resurgence of the virus this winter. But to move that quickly, it may need to abandon the lengthy human trials that have been used to test coronavirus vaccines over the past two years in favor of a faster process that relies more on laboratory tests and animal trials. The most recent trials with human volunteers have taken five months, even using relatively small groups. But the virus is evolving so quickly that new vaccine formulations are out of date before such trials are even finished.
27th Jun 2022 - The New York Times

Long Covid 2: supporting the mental and physical needs of patients

Long Covid is a multi-system condition affecting both the body and the mind that occurs in some people as a lingering consequence of a Covid-19 infection (Maxwell et al, 2022). As described in our first article in this series, symptoms are diverse and many post-Covid-19 sequelae present as undifferentiated symptoms not apparent on routine investigation (Maxwell et al, 2022). This can contribute to patients’ symptoms not always being taken seriously by health professionals. Lack of clarity over the mechanisms for long Covid means opinion can be polarised, with some practitioners believing all symptoms are physical and others that they are purely psychological. In truth, there is ample evidence that long Covid is a combination of physical and mental symptoms, many of which are undifferentiated and common in established physical and psychological conditions. Individual prognosis for individuals is hard to assess, with some people recovering within months but others still having problems after two years.
27th Jun 2022 - Nursing Times

BioNTtech in conflict with regulator over new COVID vaccine approval - WAS

The launch of German drugmaker BioNTech's vaccine adapted to the Omicron coronavirus variant may be delayed due to a disagreement with the regulator over the approval process, the Welt Am Sonntag (WAS) newspaper reported on Saturday. The regulator should still decide by the end of June whether or not to approve the new vaccine but BioNTech Chief Executive Ugur Sahin does not plan to submit any new clinical trials, WAS reported, citing the Financial Times.
27th Jun 2022 - Reuters

Sinovac's COVID-19 vaccine conditionally registered in South Africa

China's Sinovac Biotech said on Saturday that South Africa's health products regulator has granted conditional registration to its coronavirus vaccine CoronaVac for people aged 18 and above.
27th Jun 2022 - Reuters

China's Clover says its COVID booster shot candidate lifts antibody against Omicron

China's Clover Biopharmaceuticals said on Monday a booster shot of its COVID-19 vaccine candidate significantly increased antibody response against the Omicron coronavirus variant from levels seen after two primary shots. A third dose of its vaccine candidate SCB-2019 resulted in a 19-fold increase in neutralising antibody levels against the Omicron BA.2 subvariant from pre-booster levels, Clover said in a filing to the Hong Kong stock exchange.
27th Jun 2022 - Reuters

US grapples with whether to modify COVID vaccine for fall

U.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match recent changes of the shape-shifting coronavirus. Moderna and Pfizer have tested updated shots against the super-contagious omicron variant, and advisers to the Food and Drug Administration will debate Tuesday if it’s time to make a switch — setting the stage for similar moves by other countries. “This is science at its toughest,” FDA vaccine chief Dr. Peter Marks told The Associated Press, adding that a final decision is expected within days of the advisory panel’s recommendation.
27th Jun 2022 - The Associated Press

FDA panel to advise on whether — and how — Covid vaccines should be updated

The Food and Drug Administration faces an important decision in coming days — whether to instruct companies that make Covid-19 vaccines to update the viral strain or strains of SARS-CoV-2 those products target. It seems almost a given that the FDA will tell manufacturers that it is time to change the composition of Covid vaccines, with an eye to a rollout of updated vaccines to be administered in the autumn. But how and to what are questions that still need answering. The agency is seeking the advice of its independent panel of vaccine experts, the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, to help it decide how, in the words of senior FDA official Peter Marks, to predict the future. VRBPAC meets Tuesday to discuss the issue.
27th Jun 2022 - STAT News

Pfizer says its Omicron-containing boosters outperform current vaccine

Pfizer said Saturday that using new versions of its Covid-19 vaccine as boosters led to a superior antibody response against the Omicron variant compared to its current shot. The results in some ways mirror those released by Moderna earlier this month. Data from both companies will be evaluated on Tuesday by a panel of experts convened by the Food and Drug Administration in the hopes of deciding what strains of the SARS-Cov-2 virus should be included in booster shots for the fall. Companies will need lead time to manufacture doses of new vaccines if it is decided they are needed.
26th Jun 2022 - STAT News


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

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Pfizer’s Omicron-Targeting Covid-19 Vaccines Generate Stronger Immune Response

Federal health authorities are trying to decide whether to stick with the current shots for a fall vaccination campaign or use a tweaked version. Studies have found that the current vaccines don’t work as well against Omicron as they did against earlier strains. “Based on these data, we believe we have two very strong Omicron-modified candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” Pfizer Chief Executive Albert Bourla said. The study didn’t measure whether and how well the shots reduced the risk of Covid-19. Pfizer and BioNTech announced the results by news release. The findings haven’t been published in a peer-reviewed medical journal. Omicron is the most recent strain of the virus to come to predominate in the U.S. and many other countries.
26th Jun 2022 - The Wall Street Journal

Australia struggles against vaccine fatigue as it battles flu outbreak

Australia is battling its first serious influenza outbreak since the start of the Covid-19 pandemic, leaving the authorities struggling to persuade a vaccine-weary public to get flu shots. Official data showed there were 65,770 flu cases in May - more than double the month's previous record set during a severe outbreak in 2019. But the numbers have been rapidly increasing. According to the federal government's influenza surveillance system, there were 147,155 cases of flu recorded from Jan 1 to June 19 this year. Of these, 55,101 or more than one third occurred from June 5. There have been 54 flu-related deaths.
26th Jun 2022 - The Straits Times

Expert on why you need your covid booster jab now to keep safe this winter

England’s leading NHS medic is urging those eligible for a spring booster but yet to come forward to take up the offer as soon as possible as a quarter of a million reminders go out before the end of the month. The largest and fastest vaccination programme in NHS history has now invited everyone eligible for a spring booster and more than four in five people have already had their jab. The NHS has invited more than five million people in total to get their spring booster in line with JCVI guidance as part of the world-leading NHS Covid-19 vaccination programme. It is urging anyone yet to come forward for a spring dose to do so as soon as practically possible. More than four million people and around 86% of those aged 75 and over have already had their spring dose. Those who are eligible include older adult care home residents, people aged 75 and over and those who are immunosuppressed.
25th Jun 2022 - Daily Post Wales

GSK announces that COVID-19 vaccine candidate is effective at preventing Omicron infection

The Europen companies GSK and Sanofi have partnered for a COVID-19 vaccine candidate that is 72% effective at preventing infection from the Omicron variant. The companies are hoping their shot can join the Pfizer, Moderna and Novavax vaccines in becoming available for the long-term fight against Covid. It comes as U.S. regulators face widespread criticism after the controversial approval of jabs for children six months to four year old. It comes as Covid case figures have stabilized at 99,984 per day in the U.S., but deaths have jumped 20% over the past week to 385 daily
25th Jun 2022 - Daily Mail

Greece Under Fire for Recommending 2nd COVID-19 Booster for 30+

Greek authorities’ decision to recommend a second COVID-19 booster shot for individuals over thirty was criticized by a leading health specialist on Friday. The current recommendation for a second booster shot for people aged 30 to 59 who do not belong to the vulnerable groups “is not accompanied by the necessary documentation,” Elias Mossialos, Professor of Health Policy at the London School of Economics and Political Science (LSE), has posted on Facebook. Greece’s National Vaccination Committee reiterated a “strong recommendation” that those aged 60 and over get a second booster shot. Appointments for that age category have been available since early April this year.
25th Jun 2022 - Greek Reporter

The next COVID booster shots will likely be updated for Omicron

COVID-19 vaccines this fall are likely to be based on the Omicron variant of the coronavirus rather than the original strain, although some experts suggest they may only offer significant benefits for older and immunocompromised people. Moderna, Pfizer and Novavax have been testing vaccines based on the first BA.1 Omicron variant that became dominant last winter, driving a massive surge in infections. On Wednesday, Moderna said its updated vaccine worked well against more recent Omicron subvariants, and that it was moving forward with plans to ask regulators for approval. Vaccines that can bridge the gap between the original version of coronavirus and the Omicron variant would likely be “far, far better” for the fall, according to Trevor Bedford, a biologist at the University of Washington who has closely tracked mutations of the SARS-coV-2 virus.
25th Jun 2022 - Edmonton Journal

Global impact of the first year of COVID-19 vaccination: a mathematical modelling study

COVID-19 vaccination has substantially altered the course of the pandemic, saving tens of millions of lives globally. However, inadequate access to vaccines in low-income countries has limited the impact in these settings, reinforcing the need for global vaccine equity and coverage.
25th Jun 2022 - The Lancet

Sanofi-GSK Covid vaccine found effective against Omicron

Sanofi and GlaxoSmithKline have reported promising results from trials of their Covid-19 vaccine, which has proved to be particularly effective against the Omicron strain of coronavirus. The vaccine targets the original and the Beta strains of coronavirus but was also tested against the more recent Omicron variant. When used as a first dose, it demonstrated a 64.7 per cent efficacy rate against symptomatic infection overall in adults, and was 72 per cent effective against infections caused by Omicron. The vaccine was safe and well-tolerated in a trial of 13,000 people
25th Jun 2022 - Financial Times

WHO says over 900 probable cases of acute hepatitis reported in children

Thirty-three countries have reported 920 probable cases of severe acute hepatitis in children so far, a jump of 270 from May, the World Health Organization (WHO) said on Friday. The WHO said that the European Region accounted for half the probable cases, including 267 from the United Kingdom, while a third of the probable cases were from the United States. Health authorities globally have been investigating the mysterious rise in severe cases of hepatitis - or liver inflammation – in young children. The outbreak was first reported in April in Britain and has since then hit dozens of other countries.
25th Jun 2022 - Reuters