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

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Covid Therapy News and Research: Brii Says 80% Cut of Hospitalization

Brii Biosciences Ltd. said additional results of a late-stage study of a Covid-19 therapy confirmed a significantly reduced risk of death and hospitalization. The topline data readout from the National Institutes of Health-sponsored trial showed combined hospitalization and death risk cut by 80% for “non-hospitalized Covid-19 patients at high risk of clinical progression,” the Chinese company said in a Hong Kong stock exchange filing Sunday. That’s was in line with a 78% reduction disclosed in August, based on an interim analysis. In-vitro testing data suggest the therapy is able to treat those with Covid-19 variants including delta, Brii said, while efforts are ongoing to determine effects against the emerging omicron variant.
5th Dec 2021 - Bloomberg

Lilly’s Covid-19 Antibody Treatment Authorized for Use in Children

Eli Lilly & Co.’s monoclonal antibody drug has been cleared for emergency use in children under the age of 12, the Food and Drug Administration said on Friday. The authorization is the first for an antibody drug to treat young children, including newborns, who have tested positive for Covid-19 or been exposed to the virus and who are at high risk of developing severe cases including hospitalization or death. “Now all patients at high risk of severe Covid-19, including children and newborn babies, have an option for treatment and post-exposure prevention,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. Children under one year of age who are exposed to the virus that causes Covid-19 may be at particularly high risk of severe disease, said Dr. Cavazzoni. She emphasized, however, that antibody drug treatment isn’t a substitute for vaccination, which is authorized for children five years of age and up.
5th Dec 2021 - The Wall Street Journal

Omicron Mutations Signal Vaccine Evasion, But Similar Symptoms

As fears of another global surge of Covid-19 cases send jitters through global markets, spur a new round of travel bans and cause Americans to rethink their holiday plans, scientists studying the omicron variant are getting the first hints of what’s in store for the months to come. The new variant’s mutations suggest that it is likely to evade the protections of vaccines to at least some extent, but that it is unlikely to cause more severe illness than previous versions of the coronavirus. These early hypotheses appear in line with real-world observations from places like South Africa, where infections have included the vaccinated and previously ill but appear so far largely mild.
5th Dec 2021 - Bloomberg

Omicron variant may have picked up a piece of common-cold virus

The Omicron variant of the virus that causes COVID-19 likely acquired at least one of its mutations by picking up a snippet of genetic material from another virus - possibly one that causes the common cold - present in the same infected cells, according to researchers. This genetic sequence does not appear in any earlier versions of the coronavirus, called SARS-CoV-2, but is ubiquitous in many other viruses including those that cause the common cold, and also in the human genome, researchers said.
4th Dec 2021 - Reuters

Omicron Cases at Norway Christmas Party Provide Clues on New Variant’s Spread

An Omicron outbreak at a Norwegian Christmas party is providing an early, if still anecdotal, data point on the ease through which the new variant spreads between vaccinated people, and how mild its symptoms at times can be. Before Scatec AS A, a Norway-based renewable-energy company, hosted the annual holiday party, it took all the major safety precautions, said Stian Tvede Karlsen, a company spokesman. Only vaccinated employees were invited. All had to take a rapid test the day before. The party, at Louise, an upscale Oslo restaurant serving seafood and Scandinavian fare, included about 120 people, several of whom had just returned from South Africa, where the company has a solar-panel project. More than half of those present have since tested positive for Covid-19, with at least 13 confirmed to have the new variant in what appears to be the world’s biggest Omicron outbreak outside southern Africa—and a glimpse into how it fares in a highly-vaccinated population.
4th Dec 2021 - The Wall Street Journal

Most Covid Vaccines Will Work as Boosters, Study Suggests

People looking for a booster shot of a Covid-19 vaccine probably don’t need to fret about what brand it is: Many combinations of shots are likely to provide strong protection, according to a large new study. In a comparison of seven different vaccine brands, British researchers found that most of them prompted a strong immune response, with the mRNA shots from Moderna and Pfizer-BioNTech eliciting the largest responses. The study was published on Thursday in The Lancet. These are welcome data for policymakers,” said Merryn Voysey, a statistician at the University of Oxford who was not involved in the study. “The most significant take-home message here is that there are a large number of excellent boosting options for third doses.”
3rd Dec 2021 - The New York Times

Key Omicron Findings May Be Known in Days, WHO Scientist Says

Urgent studies to understand how effective Covid vaccines are against omicron have begun in a global collaboration that may yield answers in a few days, a World Health Health Organization scientist said. Some 450 researchers around the world have begun work to isolate the highly mutated variant from patient specimens, grow it in the lab, verify its genomic sequence, and establish methods to test it in blood-plasma samples, said Ana-Maria Henao-Restrepo, who co-leads the WHO’s research and development blueprint for vaccines and innovations during outbreaks and pandemics.
3rd Dec 2021 - Bloomberg

How Scientists Race Against Omicron and Future Variants

What happens when two nasty Covid-19 variants get together and share their most effective mutations? Omicron and delta have brought us closer to the answer, says Peter White, a virologist at the University of New South Wales who warns of the inevitability of a new Covid-19 "super strain." He joined Stephanie Topp, a global public health expert at James Cook University in Townsville, Australia, and Bloomberg Opinion columnist David Fickling for a Twitter Spaces discussion on the implications of the newest coronavirus variant shaking up the world. Leading the conversation, which has been lightly edited for length and clarity, is Bloomberg Opinion columnist Anjani Trivedi.
3rd Dec 2021 - Bloomberg

WHO's top scientist says Omicron could displace Delta

The World Health Organization's chief scientist told the Reuters Next conference on Friday the Omicron variant could become dominant because it is highly transmissible, but that a different vaccine may not be needed. Soumya Swaminathan also said it was too early to say whether Omicron is milder than other variants of the coronavirus that causes COVID-19 and cast doubt over its origin, saying it was far from certain it emerged in southern Africa. "It is possible that it could become (the) dominant variant," Swaminathan said, adding that it was however impossible to predict. The Delta variant now accounts for 99% of infections globally, she said.
3rd Dec 2021 - Reuters

BioNTech CEO says vaccine upgrade on the cards, ready to move quickly

BioNTech should be able to adapt its coronavirus vaccine relatively quickly in response to the Omicron variant, and the next few weeks will show how urgently an upgrade is needed, its CEO Ugur Sahin told the Reuters Next conference on Friday. Sahin said people should continue to seek the established shot, developed with Pfizer as it very likely continues to protect against severe disease. "I believe in principle at a certain timepoint we will need a new vaccine against this new variant. The question is how urgent it needs to be available," Sahin said.
3rd Dec 2021 - Reuters

Slovakia's COVID-19 case record inflated by system glitch

Slovakia reported 15,278 new COVID-19 cases on Friday, the highest number in a single day since the pandemic broke out, but the Health Ministry said a technical issue inflated the number. "The reason for today's high number of positive test results is additional data, which did not pass from laboratories to the information system on Nov. 30," the ministry said. The ministry did not specify the actual number of cases detected on Thursday. The country of 5.5 million has 3,404 people hospitalised with the illness, including 630 in intensive care.
3rd Dec 2021 - Reuters

Valneva says no conclusions to be drawn on its COVID shot from UK booster study

French biotech firm Valneva said on Friday no conclusions should be drawn on the effectiveness of its COVID-19 vaccine by a British study, which found it was the only shot out of seven that offered no immunity boost when given to people previously immunized with Pfizer's vaccine. Shares in Valneva fell by up to 24% on Friday following the publication of results of Britain's COV-Boost study, which looked at the effectiveness of alternative vaccines as boosters for people who previously received Pfizer or AstraZeneca shots.
3rd Dec 2021 - Reuters

WHO chief scientist urges people not to panic over Omicron

The International Monetary Fund is likely to lower its global economic growth estimates due to the new Omicron variant of the coronavirus, the global lender's chief said at the Reuters Next conference on Friday in another sign of the turmoil unleashed by the ever-changing pandemic. Omicron has spread rapidly to at least 40 countries since it was first reported in South Africa last week, officials say, and many governments have tightened travel rules to try to keep it out
3rd Dec 2021 - Reuters

Omicron likely less severe due to vaccine, prior infection: India

India’s health ministry says the severity of COVID-19 disease from the Omicron variant in the country could be low due to vaccination and widespread exposure to the Delta variant that infected nearly 70 percent of the population by July. “Given the fast pace of vaccination in India and high exposure to Delta variant as evidenced by high seropositivity, the severity of the disease is anticipated to be low,” it said in a statement on Friday.
3rd Dec 2021 - Aljazeera.com

Germany: 1 in 100 infected with virus, health minister says

Germany's health minister said Friday that more than 1% of the population is currently infected with the coronavirus, and he called on citizens to get vaccinated if they haven't done so yet. The country confirmed 74,352 new daily COVID-19 cases and 390 additional deaths, figures published by the federal disease control agency showed . According to the Robert Koch Institute's calculations, some 925,800 people in Germany are considered actively infected with the virus.
3rd Dec 2021 - The Associated Press on MSN.com

‘The fire that’s here’: US is still battling delta variant

While all eyes are on the new and little-understood omicron variant that is popping up around the country, the delta form of the coronavirus isn’t finished wreaking havoc in the U.S., swamping hospitals with record numbers of patients in the Midwest and New England. “Omicron is a spark that’s on the horizon. Delta variant is the fire that’s here today,” said Dr. Nirav Shah, director of the state Center for Disease Control and Prevention in Maine, where an unprecedented 334 people were in the hospital with COVID-19 as of midweek. The U.S. recorded its first confirmed omicron infection on Wednesday, in a Californian who had been to South Africa, where the variant was first identified a week ago. Several more cases were reported Thursday — five in the New York City area and one each in Minnesota, Hawaii and Colorado — under circumstances suggesting the variant has begun spreading within the U.S.
3rd Dec 2021 - The Associated Press

WHO says measures used against delta should work for omicron

Measures used to counter the delta variant should remain the foundation for fighting the coronavirus pandemic, even in the face of the new omicron version of the virus, World Health Organization officials said Friday, while acknowledging that the travel restrictions imposed by some countries may buy time. While about three dozen countries worldwide have reported omicron infections, including India on Thursday, the numbers so far are small outside of South Africa, which is facing a rapid rise in COVID-19 cases and where the new variant may be becoming dominant. Still, much remains unclear about omicron, including whether it is more contagious, as some health authorities suspect, whether it makes people more seriously ill, or whether it can evade vaccine protection.
3rd Dec 2021 - The Associated Press

BioNTech CEO says likelihood of annual COVID-19 vaccines increasing

The likelihood that people will need to have an annual COVID-19 vaccine, similar to the influenza shot, is increasing, German company BioNTech, chief executive and co-founder Ugur Sahin told the Reuters Next conference on Friday.
3rd Dec 2021 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 3rd Dec 2021

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Italy approves Pfizer and BioNTech’s Covid-19 vaccine for children

The Italian Medicines Agency (AIFA) has approved the use of the Pfizer and BioNTech Covid-19 vaccine, Comirnaty, for children aged five to 11 years. The Covid-19 vaccine is approved to be administered in two doses at a gap of three weeks. The dosage for this age group is indicated to be a third of the authorised 30µg dose given to adults and adolescents. AIFA’s Technical Scientific Commission (CTS) noted that the vaccine showed a high efficacy level with no warning signals highlighted in terms of safety, according to the data submitted by the companies. The CTS stated that “although SARS-CoV-2 infection is certainly more benign in children, in some cases it can be associated with serious consequences, such as the risk of developing multisystem inflammatory syndrome (MIS-c), which may also require hospitalisation in intensive care.”
2nd Dec 2021 - Pharmaceutical Technology

New Covid-19 drug Sotrovimab that could be effective against the Omicron variant approved by regulators

The Medicines and Healthcare products Regulatory Agency has authorised the drug for use in people with mild to moderate Covid-19 symptoms but who are at a higher risk of developing severe disease. Work will now be done to see if the drug will be effective against the new Omicron strain,
2nd Dec 2021 - iNews

COVID-19: 'Trigger' behind extremely rare AstraZeneca vaccine blood clots may have been discovered

Scientists led by a team from Arizona State University and Cardiff University worked with AstraZeneca to investigate the causes of thrombosis with vaccine-induced immune thrombocytopenia (VITT). TTS, which involves the formation of blood clots, is a life-threatening condition seen in a very small number of people after receiving the Oxford-AstraZeneca or Johnson & Johnson vaccines. The scientists say they now believe they have identified how a protein in the blood is attracted to a key component of the vaccine.
2nd Dec 2021 - Sky News

Covid-19 variants may not evolve to be less dangerous, says Neil Ferguson

People should not assume that Covid will evolve to become a milder disease, a senior scientist has warned, adding that the threat posed by the Omicron coronavirus variant will not be clear until the end of December. Prof Neil Ferguson, head of the disease outbreak analysis and modelling group at Imperial College London, told MPs on Wednesday that while evolution would drive Covid to spread more easily the virus might not become less dangerous. “Most of the transmission has already happened by the time people get hospitalised,” Ferguson told the Commons science and technology committee. “The virus cares about replicating very fast within the respiratory tract and getting out into the environment. If that happens to kill somebody 10 days later the virus really doesn’t care.”
2nd Dec 2021 - The Guardian

Pfizer begins application for Canada's approval of COVID-19 pill

Pfizer Inc said it had started the real-time submission of its application seeking Health Canada's approval of its oral COVID-19 antiviral drug candidate. The pill, PF-07321332, is designed to block a key enzyme needed for the coronavirus to multiply. The move comes after the Canadian government announced that it was in advanced talks with Pfizer and Merck & Co Inc regarding a purchase agreement for their COVID-19 antiviral drugs, as the country attempts to control the spread of the Omicron coronavirus variant.
2nd Dec 2021 - Reuters

Cuba to upgrade homegrown COVID-19 vaccine to confront Omicron

Cuban health authorities said that researchers in the communist-run country are upgrading its homegrown COVID vaccines to ensure protection against the new Omicron variant. The Caribbean island nation, whose economy hinges on tourism, sharply eased entry requirements in mid-November following a successful inoculation drive with domestically developed vaccines. Both infections and deaths from COVID-19 have dropped off to 2% or less of their peaks, according to a Reuters tally.
2nd Dec 2021 - Reuters

S.African data suggests Omicron gets around some, not all immunity

The Omicron variant appears able to get around some immunity but vaccines should still offer protection against severe disease, according to the latest data from South Africa where it is fast overtaking Delta to become the dominant variant.
2nd Dec 2021 - Reuters

EU regulator begins real-time review of Valneva's COVID-19 shot

The European Union's drug regulator said on Thursday it had started a rolling review of the inactivated-virus COVID-19 vaccine from French biotech firm Valneva, weeks after the EU signed a deal with the company for supplies of the shot. The decision to start the real-time review was based on preliminary studies that suggest the vaccine, VLA2001, triggers an antibody response against the coronavirus, the European Medicines Agency (EMA) said.
2nd Dec 2021 - Reuters

China accelerating research into COVID-19 shots targeting Omicron -state media

China is accelerating research and development of COVID-19 vaccines targeting the Omicron variant, a health official said on Thursday, amid concerns among global scientists that it may spread more quickly than other strains. Mainland China has not detected any Omicron case yet. "We are rapidly pushing forward the research and development of Omicron-specific vaccines based on different technologies," Zheng Zhongwei, who heads a group tasked with COVID-19 vaccine development in China, told state broadcaster CCTV.
2nd Dec 2021 - Reuters

Britain approves GSK-Vir antibody-based COVID-19 treatment

Britain's drug regulator on Thursday approved GSK and Vir Biotechnology's antibody based COVID-19 treatment, Xevudy, for people with mild-to-moderate COVID-19 who are at high risk of developing severe disease. The approval comes as GSK separately announced the treatment has shown to work against the Omicron variant.
2nd Dec 2021 - Reuters

Severe COVID tied to high risk of death, mostly by other causes, within year

Survivors of severe COVID-19—especially those younger than 65 years—may be at more than twice the risk of dying within the next year than those who had mild or moderate illness or were never infected, finds a study today in Frontiers in Medicine. Another finding of the analysis of electronic health records of 13,638 patients who tested positive or negative for COVID-19 is that only 20% of those who had severe COVID-19 (requiring hospitalization) and died did so because of complications of their infection, such as abnormal blood clotting, respiratory failure, or cardiovascular problems. Rather, 80% were due to different reasons typically considered unrelated to COVID-19. "Since these deaths were not for a direct COVID-19 cause of death among these patients who have recovered from the initial episode of COVID-19, this data suggests that the biological insult from COVID-19 and physiological stress from COVID-19 is significant," wrote the University of Florida at Gainesville researchers.
2nd Dec 2021 - CIDRAP

Aspen Pharmacare, pursuing J&J vaccine license, aims to shore up local capacity and quash shot inequality in Africa

History is repeating for Aspen Pharmacare. Nearly 20 years ago, as Africa grappled with an HIV epidemic, Aspen pioneered the first generic antiretroviral on the continent. Now, it has a chance to do something similar with Johnson & Johnson's COVID-19 vaccine. This time, however, the South African drugmaker's contribution could be even more of a "game changer," thanks to the scope of the pandemic and the disproportionate toll it's taken on Africa, an Aspen executive told Fierce Pharma. Aspen earlier this week signed a nonbinding term sheet with two J&J subsidiaries in a bid to license and sell the company's single-dose COVID-19 vaccine in Africa. The potentially "monumental" agreement is big for two reasons, Stavros Nicolaou, Ph.D., group senior executive of strategic trade at Aspen Pharma Group, said in an interview.
2nd Dec 2021 - FiercePharma

Another fight for Covid long-haulers: having their pain acknowledged

After his second hospitalization for acute Covid-19, Tony Marks expected to get better. Then pain invaded the 54-year-old software executive’s arms and legs. At first, he felt like he was covered by deep bruises, although nothing was visible on his skin. These days, he told me, he feels like he’s being beaten repeatedly with a baseball bat. Pain is increasingly being recognized as a key feature of what is commonly called long Covid, in which symptoms persist after the acute phase of the viral infection ends. In a recent study from Italy, for example, one-third of Covid long-haulers had symptoms of fibromyalgia or widespread muscle or bone pain. Other research links Covid-19 to neuropathic pain — often described as burning, stabbing, or feeling like electrical shocks — that results from damage to the nervous system. Pain, which also includes headache, ranks among the top symptoms of long Covid in large longitudinal studies.
2nd Dec 2021 - STAT News

Some experts suggest Omicron variant may have evolved in an animal host

When Covid-19 variants arise, the accepted wisdom is that the constellation of mutations they contain developed in an immunocompromised person who contracted the virus and couldn’t shake the infection. But some scientists have an alternative theory for where the latest variant of concern, Omicron, may have acquired the unusual mutations that stud its spike protein. They speculate the virus could have evolved in another animal species. The theory goes that some type of animal, potentially rodents, was infected with the SARS-CoV-2 virus sometime in mid-2020. In this new species, the virus evolved, accumulating roughly 50 mutations on the spike protein before spilling back over into people.
2nd Dec 2021 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 2nd Dec 2021

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COVID-19: Most Omicron cases are 'mild' and there's no evidence to suggest vaccines may be less effective against the variant, says WHO official

Early indications suggest most Omicron coronavirus cases are "mild", an official at the World Health Organisation (WHO) has said. Speaking on behalf of the organisation, the official said there is no evidence to suggest the efficacy of vaccines has been reduced by the new strain - but did say some mutations of the virus indicate an increased risk of quicker transmission. They said more than 40 different mutations have been identified with the Omicron variant. The WHO official, quoted by Reuters, added there is still a lot unknown about the new strain.
1st Dec 2021 - Sky News

COVID-19: NERVTAG scientists 'can't rule out' Omicron causing biggest wave of infections yet that may overwhelm NHS

The Omicron variant could trigger a surge in COVID infections bigger than previous waves in the UK with a risk it may overwhelm the NHS, a key group of scientists have warned. Experts on the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), which advises the government, held an extraordinary meeting last week to consider the new COVID variant, known scientifically as B.1.1.529, following its detection in South Africa. According to a note of their meeting, which was observed by both a key Department of Health official and England's deputy chief medical officer Jonathan Van-Tam, the group concluded the introduction of Omicron to the UK "might have very serious consequences".
1st Dec 2021 - Sky News

Severe Covid infection doubles chances of dying in following year, study finds

Patients who survive severe Covid are more than twice as likely to die over the following year than those who remain uninfected or experience milder virus symptoms, a study says. The research, published in Frontiers in Medicine, suggests that serious coronavirus infections may significantly damage long-term health, showing the importance of vaccination. The increased risk of dying was greater for patients under 65, and only 20% of the severe Covid-19 patients who died did so because of typical Covid complications, such as respiratory failure.
1st Dec 2021 - The Guardian

Philippines says COVID variants highlight need for local vaccine development

New coronavirus variants highlight the need for countries to do their own research and development on COVID-19 vaccines, said a senior Philippines trade official, adding that people will only be safe once the whole world is vaccinated. The Philippines is looking to work with its trading partners on this as vaccine demand is unlikely to wane anytime soon, said Allan Gepty, assistant secretary at the Department of Trade and Industry in an interview at the Reuters Next conference. The new COVID-19 variants highlight that "we have to continue doing our respective research and development in this area because there is a truism that …no one is safe unless everyone is safe," said Gepty.
1st Dec 2021 - Reuters

BioNTech CEO says vaccine likely to protect against severe COVID from Omicron

BioNTech and Pfizer's COVID-19 vaccine will likely offer strong protection against any severe disease from the new Omicron virus variant, BioNTech's Chief Executive told Reuters, as the firm weighs the need to upgrade its commonly used shot. Lab tests are underway over the next two weeks to analyse the blood of people who had two or three doses of BioNTech's Comirnaty vaccine to see if antibodies found in that blood inactivate Omicron, shedding light on whether new vaccines are needed.
1st Dec 2021 - Reuters

Regeneron's COVID-19 antibody drug may be less effective against Omicron

Regeneron Pharmaceuticals Inc's COVID-19 antibody drug could be less effective against Omicron, it said on Tuesday, adding to fears about the efficacy of existing treatments after Moderna's top boss raised similar concerns about the company's vaccine. Global markets tumbled after comments from Moderna's chief executive officer rekindled worries that the variant may weigh on a nascent global economic recovery.
1st Dec 2021 - Reuters

U.S. FDA panel narrowly backs Merck's at-home COVID-19 pill

A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's (MRK.N) antiviral pill to treat COVID-19. If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency. Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.
1st Dec 2021 - Reuters

WHO members agree to start drafting global pandemic convention

Member states of the World Health Organization (WHO) have agreed to start drafting a global agreement to prevent and tackle the next global pandemic. Countries adopted a resolution on Wednesday at a special meeting in Geneva, launching the process that it is hoped should result in a new agreement on pandemics.
1st Dec 2021 - AlJazeera

Weak immune systems tied to more COVID-19 breakthrough infections

While COVID-19 breakthrough infections—cases after vaccination—are rare, fully vaccinated people with compromised immune systems have them three times more often than those with strong immune systems and have more severe illnesses, according to a real-world US study involving nearly 1.3 million people. In the retrospective study, published today in the Journal of Medical Economics, a team led by researchers from Pfizer analyzed the health records of 1,277,747 people aged 16 or older who had received two doses of the Pfizer/BioNTech COVID-19 vaccine from Dec 10, 2020, to Jul 8, 2021. The latter part of the study period included the emergence of the Delta (B1617.2) variant in the United States.
1st Dec 2021 - CIDRAP

Merck's COVID-19 antiviral narrowly clears FDA panel—but committee echos support for revoking nod in favor of superior option

Merck and Ridgeback’s recent report that its antiviral molnupiravir wasn’t nearly as effective as previously indicated put a damper on enthusiasm that a game-changing oral treatment for COVID-19 was near. It also drew questions at the FDA on whether to approve the pill on an emergency use basis at all. On Tuesday, an FDA advisory committee voted by the narrow margin of 13-10 to endorse the use of molnupiravir. The recommendation comes despite a host of concerns, including over the efficacy and safety of the antiviral medicine. “In my many years of chairing this committee, this is the first meeting that has gone over (its time limit), which I think speaks to the complexity of the issues,” said Lindsey Baden, M.D., of the Brigham and Women’s Hospital of Boston.
1st Dec 2021 - FiercePharma

A reason for optimism on Omicron: Our immune systems are not blank slates

The emergence of a new Covid-19 variant with a startlingly large constellation of mutations has countries around the world sounding alarms. While the concerns are understandable, experts in immunology say people need to remember a critical fact: Two years and 8 billion vaccine doses into the pandemic, many immune systems are no longer blank slates when it comes to SARS-CoV-2. The new SARS-2 variant, known as Omicron, may more easily sidestep some of the immunity of some vaccinated and previously infected people. But there’s good reason to think people who already have some immune protections may avoid the worst of what Covid infections can do to immunologically naïve people.
1st Dec 2021 - STAT News

Pfizer research head envisions a sprint to develop Omicron vaccine, if it’s needed

A top Pfizer executive says the company is hopeful that booster shots will provide sufficient protection against the Omicron variant — but has already envisioned a timeline for the development of a new vaccine if that’s not the case. Mikael Dolsten, Pfizer’s chief scientific officer, likened the company’s researchers to firefighters: They don’t know how serious the blaze will be, but need to prepare for the worst. And in this case, the worst would mean the need to develop new vaccines. “We do take the new variant of concern, Omicron, with seriousness,” Dolsten told STAT. “It can indeed be a potential new threatening wave … although we don’t know that yet. But we always start with being prepared for the worst.”
1st Dec 2021 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 1st Dec 2021

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Testing, vaccines, sequencing: experts call for multi-pronged approach to Omicron

As new cases of the Omicron coronavirus variant are uncovered across the globe and threaten to spread in America, US officials are reacting by urging vaccinations and boosters instead of imposing restrictions which have increasingly provoked political fights. But the US should quickly invest in other tools as well, experts said, including testing, genomic sequencing and surveillance, better communication, and a strong focus on global vaccine equity to prevent the emergence of new variants. All of that would prepare America better to deal with a variant that many experts suspect is probably already inside the country, even if undetected so far.
30th Nov 2021 - The Guardian

UAE approves Sputnik Light as universal booster shot against COVID-19 - RDIF

The United Arab Emirates has approved Russia's Sputnik Light vaccine as a universal booster shot against COVID-19, Russian sovereign wealth fund RDIF said on Tuesday. The Russian Direct Investment Fund, which markets the vaccine abroad, said Sputnik Light can be administered six months after the second dose of any other vaccine used in the United Arab Emirates.
30th Nov 2021 - Reuters

Becton confident its COVID-19 tests will detect Omicron variant

Becton Dickinson and Co (BDX.N) said on Tuesday it was confident that its COVID-19 tests would be able to detect the new coronavirus variant Omicron. The company sells a variety of tests for COVID-19, including antigen and PCR tests. In October, it started shipping at-home rapid COVID-19 tests in the United States that can confirm results using an entirely automated smartphone app. Becton also said it had conducted analyses of the variant using all available genome sequences from the Global Initiative on Sharing All Influenza Data (GISAID) — the largest database of novel coronavirus genome sequences in the world.
30th Nov 2021 - Reuters

Regeneron says its COVID-19 antibody drug could be less effective against Omicron

Regeneron Pharmaceuticals Inc's COVID-19 antibody drug could be less effective against Omicron, it said on Tuesday, adding to fears about the efficacy of existing treatments after Moderna's top boss raised similar concerns about the company's vaccine. Global markets tumbled after comments from Moderna's chief executive officer rekindled worries that the variant may weigh on a nascent global economic recovery.
30th Nov 2021 - Reuters

It is high time we start preparing for future pandemics

Five million lives worldwide have already been lost to COVID-19, and the World Health Organization Access to COVID-19 Tools Accelerator (WHO/ACT-A) grimly predict five million more lives will be lost to the disease in months to come. Alarmingly also, COVID-19 cases will swell from the 260 million confirmed so far to 460 million by the end of 2022. The damage from COVID-19 has been so catastrophic that, when the World Health Assembly (WHA) meets in a special session, starting November 29, its task is nothing less than preventing such a tragedy from re-occurring. The damage from COVID-19 has been so ruinous that we now need an internationally binding agreement to prevent future outbreaks from ever becoming pandemics again.
30th Nov 2021 - Aljazeera.com

Pfizer now expects to produce 80 mln courses of COVID-19 pill, CEO tells CNBC

Pfizer Inc now expects to manufacture 80 million treatment courses of its experimental COVID-19 antiviral drug, up from a previous forecast of 50 million, Chief Executive Officer Albert Bourla said in a CNBC interview on Monday. Earlier this month, Pfizer said it expects to manufacture 180,000 treatment courses by the end of this year and at least 50 million courses by the end of next year, including 21 million in the first half of 2022. "We can right now commit to 80 million doses ... thanks to our manufacturing machine," Bourla told CNBC.
30th Nov 2021 - Reuters

EU could approve shot against new Covid variant in 3-4 months

The EU drug regulator said on Tuesday it could approve vaccines adapted to target the Omicron variant of the coronavirus within three to four months if needed, but that existing shots would continue to provide protection. Speaking to the European Parliament, European Medicines Agency (EMA) executive director Emer Cooke said it was not known if drugmakers would need to tweak their vaccines to protect against Omicron, but the EMA was preparing for that possibility.
30th Nov 2021 - Reuters

U.S. FDA panel to weigh Merck's COVID-19 antiviral drug

A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's antiviral pill to treat COVID-19. If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency. Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.
30th Nov 2021 - Reuters

COVID-19 vaccine makers start work on Omicron-tailored shots

BioNTech, Moderna and Johnson & Johnson are working on vaccines that specifically target Omicron in case their existing shots are not effective against the new coronavirus variant, the companies said on Monday. The variant's emergence has triggered a strong global response as countries worried that it could spread fast even in vaccinated populations impose travel curbs and other restrictions. BioNTech SE said it had started work on a vaccine tailored to Omicron, along with partner Pfizer
30th Nov 2021 - Reuters

COVID-19 reinfection less likely to be severe; cardiac stress test useful for unexplained lingering breathlessness

Reinfections with the virus that causes COVID-19 are rarely severe, new findings suggest. Researchers in Qatar compared 1,304 individuals with a second SARS-CoV-2 infection with 6,520 people infected with the virus for the first time. The odds of developing severe disease were 88% lower for people with second infections, the researchers reported online on Wednesday in The New England Journal of Medicine.
30th Nov 2021 - Reuters

Celltrion signs COVID-19 antibody therapy supply deals with Europe

South Korean biotech company Celltrion's distribution arm has signed supply deals for its monoclonal antibody to treat COVID-19 with nine European countries, Celltrion Healthcare said on Tuesday. The European Commission earlier this month approved the company's antibody therapy Regkirona, granting marketing authorisation for adults with COVID-19 who are at increased risk of progressing to a severe condition. The first batch of 50,000 doses will be shipped to Europe this year and the company is in talks with 47 other nations including in Asia, Central and South America and the Middle East, Celltrion said in a statement.
30th Nov 2021 - Reuters

WHO warns that new virus variant poses 'very high' risk

The World Health Organization warned Monday that the global risk from the omicron variant is “very high” based on the early evidence, saying the mutated coronavirus could lead to surges with “severe consequences.” The assessment from the U.N. health agency, contained in a technical paper issued to member states, amounted to WHO’s strongest, most explicit warning yet about the new version that was first identified days ago by researchers in South Africa. It came as a widening circle of countries around the world reported cases of the variant and moved to slam their doors in an act-now-ask-questions-later approach while scientists race to figure out just how dangerous the mutant version might be. Japan announced it is barring entry to all foreign visitors, joining Israel in doing so. Morocco banned all incoming flights. Other countries, including the U.S. and members of the European Union, have moved to prohibit travelers arriving from southern Africa.
30th Nov 2021 - The Associated Press

US tracking of virus variants has improved after slow start

After a slow start, the United States has improved its surveillance system for tracking new coronavirus variants such as omicron, boosting its capacity by tens of thousands of samples per week since early this year. Viruses mutate constantly. To find and track new versions of the coronavirus, scientists analyze the genetic makeup of a portion of samples that test positive. They’re looking at the chemical letters of the virus’s genetic code to find new worrisome mutants, such as omicron, and to follow the spread of known variants, such as delta. It’s a global effort, but until recently the U.S. was contributing very little. With uncoordinated and scattershot testing, the U.S. was sequencing fewer than 1% of positive specimens earlier this year. Now, it is running those tests on 5% to 10% of samples. That’s more in line with what other nations have sequenced and shared with global disease trackers over the course of the pandemic.
30th Nov 2021 - The Associated Press

Final US hurdle for Merck’s COVID-19 pill: FDA panel review

A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. The Food and Drug Administration panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. “I see this as an incredibly difficult decision with many more questions than answers,” said panel chair Dr. Lindsey Baden of Harvard Medical School, who voted in favor of the drug. He said FDA would have to carefully tailor the drug’s use for patients who stand to benefit most.
30th Nov 2021 - The Associated Press


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 30th Nov 2021

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India's Bharat Biotech resumes exports of COVID-19 vaccine

Indian vaccine maker Bharat Biotech said on Monday it has resumed export of its COVID-19 shot, Covaxin, and has executed long-pending orders in November. The company also said exports to additional countries will commence from December, according to a statement it shared on Twitter. It was not immediately clear whether or not these exports were made under the global vaccine-sharing facility COVAX.
29th Nov 2021 - Reuters

Could the Omicron variant have been avoided? It could set back vaccine successes around the world

I am an epidemiologist working in global health, and have worked in the field of vaccines for nearly 15 years. While the scientific successes of Sars-CoV-2 vaccine development have been surreal, the inequity of the pandemic and access to vaccines has left me despondent. As Australia reaches almost 90% coverage for two doses of Covid-19 vaccination, it’s a success story worth celebrating. Covid-19 vaccination has already proved to be highly effective at dampening wide-scale community transmission in settings such as New South Wales, where a rapid rollout with high levels of first-dose coverage along with other public health measures helped with the bending of the curve. But the vast majority of low- and middle-income countries have only vaccinated a small proportion of their population. An analysis suggests that while 66% of people in high-income countries are fully vaccinated, only 2.5% of the population in low-income countries are fully protected.
29th Nov 2021 - The Guardian

COVID-19: How the spread of Omicron went from patient zero to all around the globe

The speed with which new variants of the COVID-19 virus spread around the world can leave governments scrambling to catch up. What is sometimes more remarkable is the speed with which those new variants are detected. It has taken barely two weeks from the initial testing of 'patient zero', before potentially the entire globe is readying itself to examine COVID test samples to see if they contain the Omicron variant. Patient zero, called n=1 or the index case by the scientific community, arrived at Hong Kong International Airport on 11 November, having flown in from South Africa via Doha in Qatar, on flight QR818.
29th Nov 2021 - Sky News

The new Omicron variant is a reminder that 'the virus is still in control' regardless of Covid-19 fatigue, medical professor says

The new Omicron variant might prompt a return to stricter Covid-19 measures if not enough people get vaccinated or boosted, health experts say. Omicron -- or the B.1.1.529 strain of novel coronavirus -- has already spurred international travel bans. The World Health Organization officially called it a "variant of concern" on Friday. The variant has not yet been detected in the US, the Centers for Disease Control and Prevention said in a Saturday update. "But it's fairly likely we'll see cases," said Dr. Francis Collins, director of the National Institutes of Health.
29th Nov 2021 - CNN

South Africa's Aspen in advanced talks over COVID-19 vaccine deal

Aspen Pharmacare is in advanced discussions over a potential licensing agreement to package the COVID-19 vaccine in South Africa, it said on Monday. The South African company did not mention the name of the company with which it was in talks, but in early September it said it was in talks with U.S. pharma giant Johnson & Johnson over a vaccine packaging licence. Aspen currently packages J&J's COVID-19 vaccine at its South African plant under contract, which means it does not have any pricing or distribution power over the product. The company currently produces 300 million COVID-19 vaccine doses annually under its J&J contract, which are then supplied across Africa. It plans to ramp up capacity to 1.3 billion doses by February 2024, Chief Executive Stephen Saad told Reuters in October
29th Nov 2021 - Reuters

BioNTech starts work on Omicron-specific vaccine

BioNTech SE said on Monday it had started work on a vaccine tailored to Omicron, the worrying new coronavirus variant detected in South Africa, though it was not yet clear if it would have to rework its established COVID-19 shot. The development of an adapted vaccine is part of the company's standard procedure for new variants, BioNTech, which makes vaccines together with Pfizer, said in a statement. "The first steps of developing a potential new vaccine overlap with the research necessary in order to evaluate whether a new shot will be needed," it added.
29th Nov 2021 - Reuters

Omicron poses very high global risk, world must prepare -WHO

The heavily mutated Omicron coronavirus variant is likely to spread internationally and poses a very high risk of infection surges that could have "severe consequences" in some places, the World Health Organization (WHO) said on Monday. No Omicron-linked deaths had yet been reported, though further research was needed to assess its potential to resist vaccines and immunity induced by previous infections, it added. Anticipating increased case numbers as the variant, first reported last week, spreads, the U.N. agency urged its 194 member states to accelerate vaccination of high-priority groups.
29th Nov 2021 - Reuters

Thermo Fisher says its COVID-19 tests accurately detects Omicron variant

Thermo Fisher Scientific Inc said on Monday its COVID-19 diagnostic tests can accurately detect the new coronavirus variant Omicron that has prompted several countries to shut their borders. The World Health Organisation (WHO) last week classified the Omicron variant as a SARS-CoV-2 "variant of concern," saying it may spread more quickly than other forms. Thermo Fisher's TaqPath COVID-19 assays can report accurate results even in the case where one of the gene targets is impacted by a mutation, the company said in a statement.
29th Nov 2021 - Reuters

Omicron brings COVID-19 vaccine inequity ‘home to roost’

The emergence of the new omicron variant and the world’s desperate and likely futile attempts to keep it at bay are reminders of what scientists have warned for months: The coronavirus will thrive as long as vast parts of the world lack vaccines. The hoarding of limited COVID-19 shots by rich countries — creating virtual vaccine deserts in many poorer ones — doesn’t just mean risk for the parts of the world seeing shortages; it threatens the entire globe. That’s because the more the disease spreads among unvaccinated populations, the more possibilities it has to mutate and potentially become more dangerous, prolonging the pandemic for everyone.
29th Nov 2021 - The Associated Press

Moderna says Omicron vaccine could be ready by early 2022

Moderna Inc. is having its best two-day rally in a year after the company said a new vaccine to fight the omicron strain of the coronavirus could be ready by early 2022 if required. The stock soared as much as 14% to the highest level in two months, after jumping 21% during Friday’s global risk-asset selloff, to reclaim its place as top performer on the S&P 500 year-to-date. The company mobilized hundreds of workers on Thanksgiving Day last Thursday in order to start work on omicron, Chief Medical Officer Paul Burton said over the weekend.
29th Nov 2021 - AlJazeera

Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback

The efficacy data for Pfizer’s oral COVID-19 drug now look so appealing that the Big Pharma company is boosting manufacturing capacity even before an expected emergency use authorization from the FDA. Pfizer now expects to make 80 million courses of COVID drug Paxlovid by the end of 2022, Pfizer CEO Albert Bourla told CNBC during a Monday interview. The company previously said it plans to have capacity to make 50 million courses.
29th Nov 2021 - FiercePharma

Pfizer, Moderna, J&J and AstraZeneca assess omicron's effect on their COVID-19 vaccines

With the new omicron strain fueling fear around the globe that the coronavirus is regaining momentum, makers of the world’s most successful vaccines are investigating whether they need to tweak their shots. Over the last few days, Moderna, Pfizer-BioNTech, Johnson & Johnson and AstraZeneca revealed plans to address the threat posed by omicron, which emerged in South Africa and recently was detected in Australia, Israel, Hong Kong and parts of Europe. On Friday, the World Health Organization classified omicron as a “variant of concern.” Each of the companies said it's testing an omicron-specific vaccine. Moderna said it could have a tweaked version of its shot ready early next year if necessary. In the case of the delta and beta variants, Moderna needed “60-90 days” to advance new candidates to clinical testing, it said in a release.
29th Nov 2021 - FiercePharma

With winter looming, cancer patients and doctors seek more Covid protection

Michele Nadeem-Baker is steeling herself for another winter. Diagnosed with chronic lymphocytic leukemia in 2012, she lives with an impaired immune system that even a third dose of Moderna’s Covid-19 vaccine may not be able to rouse. Living in Boston in November now that the weather has turned cold means an end to backyard dinners and a return to a world narrowed by fear of infection. “I am not alone in that feeling,” said Nadeem-Baker, a patient advocate who also spoke to STAT in June. “Everyone is dreading yet another winter in lockdown. Just because there are these third vaccinations, it doesn’t mean everyone is protected. There is still a part of the population that is not.”
29th Nov 2021 - STAT News

Scientists rapidly identified the Omicron variant. But firm answers about its impact could take weeks

The emergence of the Omicron variant of the coronavirus, with a suite of mutations that suggests it might be extra transmissible and be able to evade at least some immune protection, has the world eager for answers about what it means for the Covid-19 pandemic. But so much remains unknown largely because the variant appears to have been detected and publicized so quickly. With other variants, a matter of months passed between the time they were first documented until they were designated “variants of concern” — in some cases giving scientists more opportunity to understand them before they attracted widespread attention. With Omicron, initially identified as B.1.1.529, it all happened within about two weeks.
29th Nov 2021 - STAT News


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Botswana says 15 more cases of Omicron variant detected in country

Botswana's health minister Edwin Dikoloti said on Sunday the country had detected 15 more cases of the Omicron coronavirus variant, adding to the four confirmed cases it declared on Friday. The minister applauded its scientists for detecting the new variant in the country early, but stressed it did not emerge in Botswana as the four cases were found in people who travelled to the country on a diplomatic mission. He declined to comment on the nationalities of the four people saying the country "would not want to add to the seeming trend where the variant is stigmatised".
28th Nov 2021 - Reuters

S.African doctor says patients with Omicron variant have "very mild" symptoms

A South African doctor who was one of the first to suspect a different coronavirus strain among patients said on Sunday that symptoms of the Omicron variant were so far mild and could be treated at home. Dr. Angelique Coetzee, a private practitioner and chair of South African Medical Association, told Reuters that on Nov. 18 she noticed seven patients at her clinic who had symptoms different from the dominant Delta variant, albeit "very mild".
28th Nov 2021 - Reuters

Omicron coronavirus variant travel bans may be too late, experts say

The Biden administration is focusing on booster shots as a key weapon in efforts to protect the nation against a potentially dangerous coronavirus variant even as the extent of the threat remains unclear, according to three senior administration officials familiar with the plans. A group of senior health officials had a call with South African scientists Sunday to understand the latest about the new variant and to help inform next steps, according to one of the senior administration officials, who, like the other two, spoke on the condition of anonymity to describe internal discussions.
28th Nov 2021 - The Washington Post

New Coronavirus Variant a ‘Serious Concern’ in South Africa

Scientists in South Africa are studying a recently identified new coronavirus variant of concern, stoking fears the country may face a potentially severe fourth wave that could spread internationally. The new discovery, called B.1.1.529 until a Greek letter is assigned to it by the World Health Organization, carries an unusually large number of mutations and is “clearly very different” from previous incarnations, Tulio de Oliveira, a bio-informatics professor who runs gene-sequencing institutions at two South African universities, said at a briefing on Thursday.
27th Nov 2021 - Bloomberg on MSN.com

Merck’s Covid-19 Pill Was 30% Effective in Final Analysis, Company Says

Merck and Ridgeback Biotherapeutics said a final analysis of their experimental Covid-19 pill found the drug less effective than an early look, prompting U.S. health regulators to continue a staff review of the drug’s application days before an outside panel meets. The Food and Drug Administration made public Friday their initial review of the drug’s application, including an analysis of clinical-trial data for the drug, molnupiravir. Agency staff said the drug was effective at reducing the risk of hospitalization and death, but they didn’t take a position on whether the agency should authorize the drug. The agency also said no major safety concerns turned up in late-stage testing. The FDA said it is still conducting its review of molnupiravir, after the companies told the agency earlier this week the pill was 30% effective in a final analysis of the late-stage study results. After taking an early look at results, the companies had reported in October that molnupiravir was 50% effective.
27th Nov 2021 - The Wall Street Journal

Omicron Coronavirus Variant Raises Questions Among Scientists

The fast-spreading Omicron coronavirus variant recently identified in South Africa has virologists and health authorities on edge because of its many mutations, but much about its infectiousness and virulence remains unknown. Scientists said some of the roughly 50 mutations on the new variant, called B.1.1.529, could potentially render it more transmissible or reduce vaccine effectiveness. But it will take time for virologists and infectious-disease researchers to study the variant’s spread and the potential impact on vaccines and therapeutics. “There are several aspects of concern here, but there are lots of unknowns,” Sharon Peacock, director of the Covid-19 Genetics U.K. Consortium, said at a press briefing on Friday. “It’s so important to stress how much we don’t know at the moment about this new variant.”
27th Nov 2021 - The Wall Street Journal

Omicron Identified as Covid-19 ‘Variant of Concern,’ Triggering Global Fears

A fast-spreading new strain of the coronavirus first detected in southern Africa is a global “variant of concern” and might pose a higher risk of people falling ill with Covid-19 for a second time, the World Health Organization said Friday, as governments around the globe restricted travel from the region. WHO said there was also preliminary evidence that the variant, which it named Omicron after the Greek letter, was more transmissible than the Delta variant that is currently dominant world-wide, and other virus strains. Health authorities in Belgium, Israel, Hong Kong and Botswana said they had detected first cases of the variant. Although scientists were still figuring out the exact effects of the variant’s many mutations, its discovery highlights the continued threat posed by an evolving virus to the world’s emergence from the pandemic. The travel restrictions imposed by many countries, including the U.S., raised fears that there could be further setbacks to the reopening of economic and social life, including in Western countries with high vaccination rates.
27th Nov 2021 - The Wall Street Journal

Belgium Confirms Case of New Virus Strain in Unvaccinated Traveler

Belgium said it has confirmed one case of a concerning new Covid-19 variant in someone who traveled from abroad. Health Minister Frank Vandenbroucke told reporters the variant was detected in an unvaccinated person who first tested positive for Covid-19 on Nov. 22. The new strain prompted the European Union on Friday to recommend suspending air travel from the region. Belgium also Friday ordered a new set of steps to combat the spiraling growth of Covid-19 cases, including a closure of nightclubs for three weeks and restricting privately organized parties.
27th Nov 2021 - Bloomberg

Scientists Racing to Decode Omicron as Defenses Buy Time

Travel bans and other snap defenses that countries threw up against omicron, the new Covid-19 variant, are buying time for scientists to answer key questions that could prevent another wave of deaths.
27th Nov 2021 - Bloomberg on MSN.com

BioNTech Expects Data on Vaccine Versus New Variant in Two Weeks

BioNTech SE has begun studying the new Covid-19 variant that has emerged in southern Africa and expects the first data from laboratory tests about how it interacts with its vaccine within two weeks. The lab data will shed light on whether the new variant, called B.1.1.529, can elude the vaccine it makes together with Pfizer Inc., the German biotech said on Friday. Pfizer and BioNTech put plans in place months ago to be able to ship a new version of their shot within 100 days if necessary, a BioNTech spokeswoman said. “We understand the concern of experts and have immediately initiated investigations,” BioNTech said in a statement.
26th Nov 2021 - Bloomberg

Covid-19 Variant: Scientists Race to Decode Omicron as Strain Threatens World

Travel bans and other snap defenses that countries threw up against omicron, the new Covid-19 variant, are buying time for scientists to answer key questions that could prevent another wave of deaths. Labs in Europe, the U.S. and Africa are preparing for tests to see how the new variant is likely to behave in people who’ve been vaccinated or previously infected. Real-world research will be important too, as health authorities monitor the outbreak in South Africa closely to find out how much more transmissible the new variant will be as it spreads and whether it’s more dangerous or deadly.
26th Nov 2021 - Bloomberg

Paris makes mask wearing outdoors mandatory at public gatherings

Paris has made the wearing of face masks outside mandatory again at public gatherings as the COVID-19 infection rate in the French capital soars, police said. The police prefecture said in a statement that masks will have to be worn for gathering in public spaces, at festivals and spectacles, on markets and when standing in line.
26th Nov 2021 - Reuters

61 travellers from South Africa in Netherlands positive for COVID-19 -authorities

Dutch health authorities said that 61 people who arrived in Amsterdam on two flights from South Africa on Friday tested positive for COVID-19, and they were conducting further testing early Saturday to see if any of the infections are with the recently discovered Omicron coronavirus variant. Around 600 passengers arrived at Amsterdam's Schiphol Airport on the two KLM flights on Friday and then faced hours of delays and testing due to concerns over the new virus variant.
26th Nov 2021 - Reuters

Merck's COVID-19 pill significantly less effective in new analysis

Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported. The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
26th Nov 2021 - Reuters

Pfizer/BioNTech, Moderna expect data on shot's protection against new COVID-19 variant soon

BioNTech SE said on Friday it expects more data on a worrying new coronavirus variant detected in South Africa within two weeks to help determine whether its vaccine produced with partner Pfizer Inc would have to be reworked. Pfizer and BioNTech said that if necessary they expect to be able to ship a new vaccine tailored to the emerging variant in approximately 100 days. "We understand the concern of experts and have immediately initiated investigations on variant B.1.1.529," BioNTech said in a statement when asked to comment. "We expect more data from the laboratory tests in two weeks at the latest. These data will provide more information about whether B.1.1.529 could be an escape variant that may require an adjustment of our vaccine if the variant spreads globally," it added.
26th Nov 2021 - Reuters

Israel warns of looming emergency after its first case of omicron, new COVID-19 variant

Israel Prime Minister Naftali Bennett said on Friday that the country is “on the threshold of an emergency situation” after it detected its first case of omicron, the new South African strain of coronavirus. The Israeli Health Ministry said it detected the new strain in a traveler who had returned from Malawi, and that it is investigating two other suspected cases, The Associated Press reported. Bennett said the new variant is more contagious and spreads more rapidly than the delta variant. He added that authorities are still gathering data on how effective the coronavirus vaccines will be against the variant.
26th Nov 2021 - The Hill

COVID-19: New variant officially named Omicron and Health Secretary Sajid Javid warns of 'huge international concern' as first case found in Europe

A worrying new COVID strain has been classified by the World Health Organisation as a "variant of concern" - its most serious level - and officially given the Greek name Omicron. The WHO said the variant, first detected in South Africa and previously known as B.1.1.529, "has a large number of mutations, some of which are concerning" and early evidence suggested an increased risk of reinfection compared to other strains. "This variant has been detected at faster rates than previous surges in infection, suggesting that this variant may have a growth advantage," the organisation added.
26th Nov 2021 - Sky News

Moderna Edges Pfizer in Study of Five Covid Vaccines

The Moderna Inc. and Russian Sputnik V Covid-19 vaccines both edged the version from Pfizer Inc. and BioNTech SE in effectiveness in a large-scale study of five different immunization shots conducted by Hungarian researchers. Moderna’s vaccine was 88.7% effective in protecting against coronavirus infection and 93.6% effective against Covid-related mortality, compared with 85.7% and 95.4%, respectively for Sputnik, according to the paper published Wednesday on the website of the Clinical Microbiology and Infection medical journal. Pfizer came in third with 83.3% and 90.6%, respectively. The research reviewed the effectiveness of five vaccines in people at least seven days after they received their second dose. Data from more than 3.7 million vaccinated people aged 16 and over were reviewed from January to June of this year.
26th Nov 2021 - Bloomberg


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South African scientists detect new virus variant amid spike

A new coronavirus variant has been detected in South Africa that scientists say is a concern because of its high number of mutations and rapid spread among young people in Gauteng, the country's most populous province, Health Minister Joe Phaahla announced Thursday. The coronavirus evolves as it spreads and many new variants, including those with worrying mutations, often just die out. Scientists monitor for possible changes that could be more transmissible or deadly, but sorting out whether new variants will have a public health impact can take time.
26th Nov 2021 - Associated Press on MSN.com

New 'Botswana' variant is most mutated version of Covid

A new variant of the coronavirus with a "constellation" of mutations has been identified in Botswana. Designated as B.1.1.529, scientists are still unclear whether existing antibodies would react well to the variant - which has 32 spike protein mutations. Tom Peacock, a virologist at Imperial College London, branded the mutations "really awful".
25th Nov 2021 - Economic Times

Africa Health Body Investigates New Covid Variant in South Africa

African health authorities plan to hold talks with their South African counterparts next week about a new coronavirus variant that has been found in the country. Data on the new variant is currently being analyzed and more information will be released after the meeting, Africa Centres for Disease Control and Prevention Director John Nkengasong said in a virtual briefing on Thursday. A new Covid-19 variant with a large number of mutations has emerged, with cases reported in Botswana, South Africa and Hong Kong, the Independent reported earlier. The B.1.1529, or so-called Botswana variant, is an offshoot of another variant called B.1.1., the London-based newspaper said.
25th Nov 2021 - Bloomberg

Novavax expected to be become fourth Covid vaccine available in UK

Pfizer, AstraZeneca, Moderna. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about two others. One is the vaccine developed by Janssen, approved in May, with doses due to be delivered by the end of this year, but the UK government is now planning to donate all 20m of them to developing countries, via the Covax initiative. The other is the Novavax jab; the government has ordered 60m doses and hundreds of British jobs depend on it. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks.
25th Nov 2021 - The Guardian

COVID-19: New coronavirus variant B.1.1.529 identified in Botswana as scientists play down concerns

A new variant of the coronavirus with a "constellation" of mutations has been identified in Botswana. Designated as B.1.1.529, scientists are still unclear whether existing antibodies would react well to the variant - which has 32 spike protein mutations. Tom Peacock, a virologist at Imperial College London, branded the mutations "really awful". Spike proteins are what viruses use to get into human cells, and some of the vaccines work by training the body to recognise the spikes and neutralise them. Mutations on the spike can therefore potentially prove problematic for mRNA doses, like Pfizer and Moderna. However, with only a handful of recorded cases - three in Botswana, six in South Africa and one in Hong Kong from someone who travelled from South Africa - scientists are hopeful that COVID cases caused by the new virus specimen will not be widespread.
25th Nov 2021 - Sky News

Australia will face a new wave of Covid-19 unless booster shot rates skyrocket, expert warns

Australia will face a new wave of COVID-19 cases similar to that currently being seen in Europe unless booster shot rates dramatically increase, a leading epidemiologist has warned. It comes as several European nations have reimposed restrictions and lockdowns after a spike in infections as the continent heads into winter. While case numbers were reducing in Australia as vaccination levels increase, infectious diseases expert Professor Raina MacIntyre said the country should heed the COVID situation overseas to avoid an identical situation next year.
25th Nov 2021 - Daily Mail

Reinfection from Covid-19 is rare, severe disease is even rarer, a study of people in Qatar finds

When people got reinfected with Covid-19, their odds of ending up in the hospital or dying were 90% lower than an initial Covid-19 infection, according to a new study. The study published Wednesday in the New England Journal of Medicine found that there were few confirmed reinfections among 353,326 people who got Covid-19 in Qatar, and the re-infections were rare and generally mild.
25th Nov 2021 - CNN

Pfizer sues departing employee it says stole COVID-19 vaccine secrets

Pfizer Inc has sued a longtime employee for allegedly stealing "scores" of confidential documents, including some related to its COVID-19 vaccine, as she prepared to jump to a competitor. In a complaint filed on Tuesday in San Diego federal court, Pfizer said Chun Xiao Li breached her confidentiality agreement by uploading more than 12,000 files without permission to her personal accounts and devices from her company-issued laptop. The alleged materials include a Sept. 24 "playbook" containing internal assessments and recommendations about the Pfizer/BioNTech COVID-19 vaccine, Pfizer's relationship with its German vaccine partner, and presentations related to cancer antibodies.
25th Nov 2021 - Reuters

Turkey's domestic COVID-19 vaccine applies for emergency authorisation

Turkey's domestically developed COVID-19 vaccine, Turkovac, has applied for emergency authorisation, Health Minister Fahrettin Koca said on Thursday, adding he hoped the shot would be available for use by year-end. Speaking at his ministry's budget debate in parliament, Koca said work on Turkovac was nearing completion, and added the shot would mark the first Phase III clinical research project to be fully carried out by Turkey. "I would like to share a piece of good news for our people: our domestic inactive COVID-19 vaccine Turkovac has applied for emergency authorisation as of today," Koca said.
25th Nov 2021 - Reuters

S.Africa detects new COVID-19 variant, implications not yet clear

South African scientists have detected a new COVID-19 variant in small numbers and are working to understand its potential implications, they said on Thursday. The variant - called B.1.1.529 - has a "very unusual constellation" of mutations, which are concerning because they could help it evade the body's immune response and make it more transmissible, scientists told reporters at a news conference. Early signs from diagnostic laboratories suggest the variant has rapidly increased in the most populated province of Gauteng and may already be present in the country's other eight provinces, they said.
25th Nov 2021 - Reuters

EU regulator gives go-ahead to first COVID shot for 5-11 year olds

The EU's drug regulator approved the use of Pfizer-BioNTech's COVID-19 vaccine for children between the ages of five and 11 on Thursday, paving the way for them to be given a first shot as Europe struggles with a surge in cases. The European Medicines Agency (EMA) recommended that Pfizer-BioNTech's vaccine, approved for European Union use in teenagers between 12 and 17 years old since May, be given as an injection in the upper arm in two 10 microgram doses, three weeks apart. Adult doses contain 30 micrograms.
25th Nov 2021 - Reuters

Did AstraZeneca Keep Britain Safer From Covid Than Europe?

Pascal Soriot knows how to make a headline. The AstraZeneca Plc chief executive officer gave a rare interview to the BBC to mark the opening of a billion-pound ($1.3 billion) research facility in Cambridge. But he couldn’t resist a little plug for his vaccine, too. “If you look at the U.K., there was a big peak of infections but not so many hospitalizations relative to Europe,” he said. His suggestion — made in dulcet tones and bracketed with the caveat that more research needs to be done — is that the AstraZeneca vaccine offers more longer-term effectiveness against serious illness than rival jabs produced by Pfizer Inc. and Moderna Inc. In other words, Britain’s homegrown jab is the reason the country is faring better with the latest Covid wave than Europe.
25th Nov 2021 - Bloomberg

UK raises alarm over new COVID variant which could beat vaccines

Britain on Thursday said it was concerned by a newly identified coronavirus variant spreading in South Africa that might make vaccines less effective and imperil progress made across the world in fighting the pandemic. The UK Health Security Agency said that the variant - called B.1.1.529 - has a spike protein that was dramatically different to the one in the original coronavirus that COVID-19 vaccines are based on. Officials characterise the variant, which has double the number of mutations as the currently dominant Delta variant, as the "worst one yet".
25th Nov 2021 - Reuters

Pfizer says former employee stole trade secrets on megablockbuster COVID-19 vaccine

Pfizer and other drugmakers go to great lengths to protect their proprietary information. When it comes to the world's best-selling pharmaceutical product, the company's BioNTech-partnered COVID-19 vaccine, Pfizer's defense of trade secrets carries even more weight. That's why the company is working to get a handle on information allegedly stolen by a "soon-to-be former employee." In a new lawsuit filed in California, published by Bloomberg, Pfizer says an employee, Chun Xaio Li, uploaded more than 12,000 files, including "confidential Pfizer documents," to a personal Google Drive account and to personal devices. The company says it "has yet to understand the full scope" of the alleged theft thanks to the "sheer number" of documents involved. The company's lawsuit focuses on the COVID-19 vaccine, Comirnaty, and two cancer monoclonal antibodies.
24th Nov 2021 - FiercePharma

Emotional toll of COVID-19 on health workers is vast, varied

In the US study, a team led by Duke University researchers surveyed 1,344 HCWs in 2020 about their emotional state before the availability of COVID-19 vaccines. They recruited HCWs via email and social media from Apr 24 to May 30 (phase 1) and Oct 24 to Nov 30 (phase 2). In phase 1 involved 335 survey respondents of whom 32.6% were 35 to 44 years old, 86% were women, and 87.8% were White. Phase 2 included 1,009 participants, of whom 38.1% were aged 35 to 44, 90.5% were women, and 93.7% were White. Respondents included nurses, physicians, advanced practice practitioners, and chaplains. The HCWs reported emotions related to changes in family, social life, and occupational function. They expressed fear of contracting COVID-19 and spreading the infection to family and friends, stigmatization, short-staffing, and inadequate personal protective equipment (PPE).
24th Nov 2021 - CIDRAP

Virus expert Trevor Bedford on annual Covid boosters and the inevitable next pandemic

In January 2020, computational biologist Trevor Bedford told STAT’s Helen Branswell about the then-new coronavirus: “If it’s not contained shortly, I think we are looking at a pandemic.” Talk about a prediction. Last week at the 2021 STAT Summit, Branswell again caught up with Bedford, a scientist at the Fred Hutchinson Cancer Research Center and an expert on viral evolution and epidemiology. They talked about the future of the coronavirus and antigenic drift (essentially, whether the virus mutates in ways that escape the protection generated by vaccines or earlier infections), as well as what’s in store for flu season, and what might lie ahead with the next pandemic.
24th Nov 2021 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Nov 2021

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Ecuador to administer COVID-19 booster shots to general population in 2022

Ecuador will administer booster shots against COVID-19 to the general population starting January 2022, the government said on Wednesday, acknowledging a rise in cases in the Amazon region due to difficulties in carrying out vaccinations.
25th Nov 2021 - Reuters

Novavax expected to be approved as fourth Covid vaccine in UK

Pfizer, AstraZeneca, Moderna. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about another jab, Novavax – even though the government has ordered 60m doses and hundreds of British jobs depend on it. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks. It will bring to an end what feels like a long wait compared with the speedy development and approval of the other jabs, including for those who took part in trials.
24th Nov 2021 - The Guardian

Canada gives full approval to J&J's single-shot COVID-19 vaccine

Johnson & Johnson said Canada gave full approval to its single-shot COVID-19 vaccine for people aged 18 years and older, making it the first full approval for the vaccine globally. The vaccine was previously authorised by the country under an interim order. Canada, which is reporting 2,563 infections on average each day and has administered at least 60,101,058 doses of COVID-19 vaccines so far, gave full approval to Moderna Inc and Pfizer Inc's coronavirus vaccines in September. The country authorised the use of Pfizer's COVID-19 vaccine for children aged 5 to 11 and a booster dose for people aged 18 years and older this month
24th Nov 2021 - Reuters

Russia's Putin took part in trials of nasal form of COVID vaccine

Russian President Vladimir Putin has been revaccinated against COVID-19, Russian news agencies quoted him as saying on Sunday. Putin said in June 2021 that he had been vaccinated with Sputnik V vaccine. "Today, on your recommendation and that of your colleagues, I got another vaccination, Sputnik Light. This is called revaccination," Putin said at a meeting with the deputy director of the Gamaleya Research Centre for Epidemiology and Microbiology, which developed both vaccines.
24th Nov 2021 - Reuters

UK PM Johnson: disappointing that Valneva COVID-19 shot did not gain approval

British Prime Minister Boris Johnson said on Wednesday he was disappointed that Valneva's COVID-19 vaccine had not gained approval in Britain, two months after the government cancelled a supply deal worth 1.4 billion euro ($1.57 billion) for the shot. Health minister Sajid Javid had said commercial considerations played into the decision, but added it was clear Valneva's shot would not be approved in Britain. His statement was later corrected to say that the shot had not gained approval and may not gain it. Valneva said in a statement it hoped for approval by the end of the year and was working with the Medicines and Healthcare products Regulatory Agency (MHRA), the independent medicines regulator.
24th Nov 2021 - Reuters

South Korea's Enzychem to make Indian drugmaker Cadila's COVID-19 shot

South Korea's Enzychem Lifesciences would make at least 80 million doses of India's homegrown DNA COVID-19 vaccine from Cadila Healthcare, the Indian drugmaker said on Wednesday. As part of the deal, Cadila will transfer the DNA vaccine technology to Enzychem, which will make and sell the vaccine, ZyCoV-D, within its territory under the Cadila trademark. Cadila will get license fees and royalty payments, the company said in a filing to stock exchanges.
24th Nov 2021 - Reuters

Bharat's COVID-19 shot 50% effective at height of India infections - small study

Bharat Biotech's vaccine was only 50% effective at preventing symptomatic COVID-19 in a high-risk population during a devastating second wave of infections in India this year, data gleaned from hospital workers showed. The real world study for Covaxin, conducted April 15-May 15, compares with a 77.8% effectiveness rate in a late-stage trial of more than 25,000 participants that was conducted November 2020 to January 2021. The new data analysed just over 1,000 COVID-19 cases with a test-negative control case group, matching by age and gender, according to the study which was published in the Lancet Infectious Diseases journal.
24th Nov 2021 - Reuters

China's Homegrown Virus Pill Could Offer a Pivot From Covid Zero

Where will newly developed Covid pills be needed the most? Rather than pandemic hot spots, it’ll be a place where the virus has yet to gain a sustained foothold: China. That’s the take from Tong Youzhi, chief executive officer at Kintor Pharmaceutical Ltd., a Chinese company working on just such a product. After successfully containing the virus with mass testing, surveillance and rigid border curbs, China is now uniquely vulnerable to the novel pathogen and needs access to effective treatments if outbreaks worsen. “China is a virgin land for the virus, with so few people exposed,” Tong said in an interview with Bloomberg News. “The urgency for effective Covid drugs is no less in China than elsewhere if we want to regain our pre-pandemic life.”
24th Nov 2021 - Bloomberg

African company works to replicate Moderna's COVID vaccine, without permission, to address unequal access

There are huge gaps in the availability of COVID-19 vaccines between different countries. Just 10% of people in Africa have received a single dose, compared to 63% across North America or 62% in Europe. CBS News correspondent Debora Patta found a start-up in South Africa that hopes to redress that imbalance by reverse engineering one of the major U.S.-made vaccines, making it easier to store, and then producing it independently. A pair of nondescript warehouses in a dusty part of Cape Town is the unlikely home of a medical revolution. Inside the airlocked, sterile rooms, Patta found a band of rebels in white lab coats who are passionate about using science to change the world.
24th Nov 2021 - CBS News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 24th Nov 2021

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Mexico eyes COVID-19 vaccine booster shots, especially for older adults

Mexico will analyze administering booster vaccine doses against COVID-19, especially for older people, President Andres Manuel Lopez Obrador said on Tuesday, softening his previous stance on the need for a third shot. Less than two months ago, Lopez Obrador had rejected suggestions that Mexico should administer a third vaccine shot, saying experts deemed it to be unnecessary. But his government has gradually opened the door to giving more people shots, including teenagers.
23rd Nov 2021 - Reuters

Covaxin Gave Lower Protection Amid India's Deadly Delta-Led Wave

Covaxin, one of the main vaccines used in India’s coronavirus immunization drive, provides only 50% protection against symptomatic Covid-19, according to a real-world study that suggests the shot is less effective than initially thought. As India was slammed by its second-major Covid wave earlier this year, researchers at the All India Institute of Medical Sciences in Delhi analyzed data from 2,714 of the hospital’s health workers who were showing signs of infection and underwent RT-PCR testing between April 15 and May 15, according to a study published in The Lancet Infectious Diseases journal. At the start of the country’s vaccination campaign in January, staff at AIIMS had exclusively been offered Covaxin, a shot co-developed by India’s state-funded health research agency and Bharat Biotech International Ltd.
23rd Nov 2021 - Bloomberg

Biden Covid Vaccine Booster Plan May Face Resistance From CDC Panel, FDA

Medical experts who advise U.S. regulators on vaccines are chafing at what they perceive as political interference in the review process by the Biden administration. Last month, the White House announced plans to begin distributing Covid-19 booster shots to Americans Sept. 20. However, the effort still needs the Food and Drug Administration and the Centers for Disease Control and Prevention to sign off. Members of a key panel that advises the CDC on vaccines have pushed back consideration of the plan to mid-September and said this week they were concerned that politics was getting ahead of the process. It’s “very frightening to me that health-care providers are trying to do the best job that they can, and are taking guidance from HHS and the White House,” said Helen Talbot, a Vanderbilt University professor of medicine and member of the CDC’s Advisory Committee on Immunization Practices, in a meeting Monday.
23rd Nov 2021 - Bloomberg

The real risk of heart inflammation to kids is from COVID-19—not the vaccine

Elizabeth Brown, a mother of two who lives outside Denver, Colorado, had a tough decision to make when childhood COVID-19 vaccines became available. Her five-year-old was born with a congenital heart defect that required a risky surgery when he was two years old to avoid a lifelong risk of heart inflammation from infection. But Brown also knew that after getting some COVID-19 vaccines, adolescent boys are at risk of developing myocarditis, a different kind of inflammation of the heart. ”To read about children with no cardiac history having myocarditis as a pediatric vaccine complication was scary,” Brown says. “There were a lot of inflammatory headlines from the media that preyed on a parent’s fear in terms of the vaccination and very little information readily available regarding the damage COVID can do.”
23rd Nov 2021 - National Geographic

AstraZeneca chief: Our coronavirus vaccine could protect older people longer than mRNA jabs

The head of AstraZeneca has suggested that the company’s adenovirus vaccine could provide longer-lasting protection against COVID-19 especially in older people than the mRNA vaccines from BioNTech/Pfizer and Moderna. French CEO Pascal Soriot said this could be a reason why the U.K. hasn’t experienced the same high levels of hospitalizations as Europe, where cases have surged in recent months. But he said more data was needed. “It's really interesting, when you look at the U.K., there was a big peak of infections, but not so many hospitalizations relative to Europe,” he told BBC Radio 4. “In the U.K., this vaccine was used to vaccinate older people whereas in Europe initially people thought the vaccine doesn't work in older people,” he said. The pharma chief suggested that this could be because AstraZeneca’s adenovirus vaccine provides a better T cell response than mRNA vaccines. “The antibody response is what drives the immediate reaction or defense of the body when you are attacked by the virus,” Soriot said. “And the T cell response takes a little longer to come in. But it's actually more durable; it lasts longer.” The pharma chief said AstraZeneca’s adenovirus COVID-19 vaccine “has been shown to stimulate T cells to a higher degree in older people.”
23rd Nov 2021 - POLITICO.eu

The FDA will soon decide on Merck's Covid-19 antiviral pill. It shows promise, but there are also concerns

In the fall of 2015, Dr. Mark Denison was preparing for a long drive home from Alabama after making a presentation at a scientific meeting when a colleague asked him to stick around for lunch and check out some data on a potential new drug. Denison said yes, and six years later, he's very glad he stayed. Denison's colleague, George Painter, is a "drug hunter" at Emory University in Atlanta. At lunch, he showed Denison lab results he'd obtained with a new antiviral compound, now known as molnupiravir. "It just knocked my socks off," said Denison, an infectious disease specialist at Vanderbilt University Medical Center. "With increasing concentrations of the drug, the virus's ability to grow just plummeted." Painter's lab looked at the effect molnupiravir had against the influenza virus and chikungunya, a virus that's spread by mosquitos. After the Alabama meeting, Painter sent some of the compound to Denison, who tried it in his lab against the virus that causes Middle East Respiratory Syndrome.
23rd Nov 2021 - CNN

Pfizer says its Covid vaccine is STILL 100% effective in children ages 12 to 15 four months after the second dose

Pfizer-BioNTech released data on Monday from a long-term analysis of their COVID-19 vaccine in kids aged 12 to 15. There were 30 confirmed symptomatic Covid cases in the placebo group compared to none in the vaccinated group Researchers say this equates to 100% efficacy at least four months after receiving the second dose. The vaccine is currently only fully approved for those aged 16 and older but the companies plan to apply for extended approval in the 12-15 age group soon
23rd Nov 2021 - Daily Mail

Vaccines Ward Off Severe Covid in U.S., Wane Against Infections

Covid-19 vaccines remain highly effective at keeping people alive and out of the hospital, but new U.S. data add further support to the argument that the shots aren’t preventing infections as much as they once did. Unvaccinated people were about five times more likely to test positive for the virus than the vaccinated in the week starting Sept. 26, down from about 15 times more likely in May, according to the latest age-adjusted data from the Centers for Disease Control and Prevention, which were updated Monday. The new figures come shortly after the CDC approved booster shots for all adults, and could provide additional support for third doses as the U.S. heads into its traditional winter virus season. Covid-19 cases are rising across many parts of the U.S., including the Midwest and Northeast. The CDC data isn’t adjusted for time since vaccination. That means that the earliest recipients of the vaccine -- mostly senior citizens and those with pre-existing conditions -- are possibly at even greater risk.
23rd Nov 2021 - Bloomberg

Covid antivirals could be pandemic game-changers. But Americans might struggle to access them

Antiviral drugs for treating Covid-19 have been hailed as a pandemic “game-changer” — a tool that could, perhaps, finally help life return to normal. But basic gaps in the U.S. health system could mean that two new treatments from Pfizer and Merck won’t make much of a difference after all. The companies’ treatments, which haven’t yet received emergency authorization, could make a Covid diagnosis dramatically less threatening. But in practice, before receiving the pills, patients may need to jump through a series of hoops that often prevent Americans from accessing care: Recognizing their symptoms, taking a test, getting a prescription from a clinician, and filling the prescription at a pharmacy. “Our routine medical systems are not really set up for this,” said Céline Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration. “These are medications that need to be started within three days of developing symptoms. It can take you longer than three days to get an appointment.”
23rd Nov 2021 - STAT News

COVID-19 tied to higher risk of stillbirth, maternal death

In the first study, the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team analyzed data from the Premier Healthcare Database Special COVID-19 Release, a large, hospital-based database from March 2020 to September 2021, a period that included the emergence and eventual dominance of Delta. Of all pregnant women in the database, 53.7% were White, 50.6% had private health insurance, 15.4% were obese, 11.2% had diabetes, 17.2% had high blood pressure, 1.8% had multiple-gestation pregnancy, 4.9% smoked, and 1.73% had COVID-19. The study authors noted that most of the women who tested positive for COVID-19 at delivery were likely unvaccinated. Among 1,249,634 deliveries at 736 hospitals, stillbirths were rare, at 0.65%, but the rate was 1.26% among 21,653 deliveries to pregnant COVID-19 patients, compared with 0.64% among 1,227,981 deliveries to non–COVID-19 patients. Stillbirths were defined as fetal deaths at 20 weeks' gestation or later.
22nd Nov 2021 - CIDRAP

Pfizer, BioNTech ace long-term test of their COVID vaccine in kids 12 to 15, setting up likely approval

Six months ago, Pfizer and BioNTech secured emergency use authorization for their COVID-19 vaccine in 12- to 15-year-olds. Now, the companies have provided long-term data that could bring a full approval in the age group. In a follow-up study of 2,228 children, the vaccine was 100% effective in preventing infection seven days to four months after the second dose. There were no serious safety concerns observed in those with at least six months of follow-up. With the results, the companies will file for full FDA approval in the age group. In August, the shot won an FDA nod in people 16 and older.
22nd Nov 2021 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 23rd Nov 2021

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‘Herd immunity’ more complex than reaching 70% vaccine rate, says Oregon health expert

With COVID cases declining and the vaccine rate reaching 73%, many Oregonians are wondering when they can drop their face masks. Health experts say: not until early next year, if not longer. The COVID-19 booster is now available to all adults in Oregon. The Oregon Health Authority made the announcement Saturday, a day after the Centers for Disease Control and Prevention announced similar federal guidelines. The news comes after a weeks-long decline in COVID cases across the state. Case numbers are about half what they were at the peak of the Delta surge in September, and COVID-related hospitalizations are down to about 400 patients. By contrast, there were 1,178 COVID patients in Oregon on Sept. 1. Nonetheless, state health officials say there’s still a long road ahead.
22nd Nov 2021 - OPB News

Pfizer's Covid vaccine was 100% effective in kids in longer-term study

Pfizer and BioNTech announced Monday that their Covid-19 vaccine was 100% efficacious in preventing infections in 12- to 15-year-olds, measured from seven days to four months after administration of the second dose of the vaccine. The companies said the new data — a longer-term analysis of a Phase 3 trial conducted in 2,228 participants — will form the basis of an application to the Food and Drug Administration for an extension of their Covid-19 vaccine license to cover youths in the age group.
22nd Nov 2021 - STAT

EU considers booster doses of J&J's COVID-19 vaccine

The European Medicines Agency says it is evaluating whether to authorize booster doses of Johnson & Johnson's single-shot COVID-19 vaccine. In a statement Monday, the EU drug regulator said it was considering an application from J&J to recommend booster doses of the J&J vaccine for adults 18 and over, at least two months after they were first immunized. Amid an explosive surge of new coronavirus infections across Europe the EMA said it expected to make a decision on this within weeks. The U.S. Food and Drug Administration gave the green light to J&J booster doses in October, both for people who initially received the J&J and vaccine and for people who got immunized with other vaccines.
22nd Nov 2021 - The Independent

Covid-19: UK will avoid European Delta surge due to vaccines and growing immunity, experts say

Coronavirus vaccinations may have prevented about 300,000 deaths in the UK, a leading scientist has claimed. Professor Sir Andrew Pollard, who helped create the Oxford/AstraZeneca vaccine, has hailed the success of the UK’s vaccination programme. He told the BBC’s Andrew Marr: “If we just look at the UK, the predictions last year were that there would be between 300,000 and 500,000 deaths. “And actually when you look at the data on lives saved so far this year, we’re actually not far off to actually think that that is the right number, that we might have been at around about 300,000 deaths by now without a vaccine.” He also said immunity is building in younger age groups due to high infection levels seen since the end of summer.
22nd Nov 2021 - iNews

Revealed: Over 600 babies born premature and needing critical care to mothers hospitalised by Covid-19

More than 600 babies have been born prematurely and needing critical care to mothers hospitalised by Covid-19, The Independent can reveal — as women are warned they are up to three times more likely to have an early birth with the virus. The figures, which cover 17 months of the pandemic, prompted calls for the government to make pregnant women of all ages eligible for Covid-19 booster jabs. Concern about pregnant women avoiding the vaccine has pushed chief medical officer Chris Whitty to urge mothers-to-be to get fully jabbed, with take-up rates in this group as low as 15 per cent last month.
22nd Nov 2021 - The Independent

Baidu in partnership with Sanofi to use its algorithm in mRNA vaccine, therapy development

Chinese tech giant Baidu Inc said on Monday it has licensed its algorithm for messenger RNA (mRNA) sequence to Sanofi SA for use in designing vaccine and therapeutic products, entering its first such commercial deal with a major global drugmaker. Sanofi had been one of the world's biggest vaccine makers before the pandemic, but the French firm was beaten by rivals BioNTech /Pfizer) and Moderna in developing mRNA shots against COVID-19. read more Sanofi stopped trials of its own mRNA COVID-19 shot in September, and is instead focusing on efforts with GlaxoSmithKline to bring another COVID-19 vaccine candidate to market based on the more conventional protein-based approach.
22nd Nov 2021 - Reuters

Germany promotes 'Rolls-Royce' Moderna shot to meet demand for COVID boosters

Germany will promote Moderna for Germans seeking booster shots as high demand for the BioNTech/Pfizer vaccine risks depleting stocks and derailing efforts to tame a fourth wave of the pandemic, Health Minister Jens Spahn said on Monday. Spahn warned during a news conference that some 16 million Moderna doses could expire in the first quarter of next year if unused, adding that some experts see Moderna as the "Rolls-Royce" of vaccines with BioNTech the "Mercedes". "Unfortunately the impression is we will insist on Moderna only to avoid the expiry of those vaccines in the first quarter of 2022," said Spahn.
22nd Nov 2021 - Reuters

Pfizer's COVID-19 vaccine trial data shows long-term efficacy in adolescents

Pfizer Inc said on Monday its COVID-19 vaccine provided strong long-term protection against the virus in a late-stage study conducted among adolescents aged 12 to 15 years. A two-dose series of the vaccine was 100% effective against COVID-19, measured seven days through over four months after the second dose, the company said. The long-term data will support planned submissions for full-regulatory approval of the vaccine in the age group in the United States and worldwide.
22nd Nov 2021 - Reuters

EU says decision on J&J COVID-19 vaccine booster dose 'within weeks'

The European Union's drug regulator said on Monday it was evaluating data on booster doses of the COVID-19 vaccine by Johnson & Johnson (JNJ.N) following an application, and a decision could come "within weeks" under a speedy review. The approval sought is for use of a booster dose of the single-shot vaccine, COVID-19 Vaccine Janssen, to be given at least two months after the first dose to people aged 18 years and older, the European Medicines Agency (EMA) said.
22nd Nov 2021 - Reuters

How COVID shots for kids help prevent dangerous new variants

Cadell Walker rushed to get her 9-year-old daughter Solome vaccinated against COVID-19 — not just to protect her but to help stop the coronavirus from spreading and spawning even more dangerous variants. “Love thy neighbor is something that we really do believe, and we want to be good community members and want to model that thinking for our daughter,” said the 40-year-old Louisville mom, who recently took Solome to a local middle school for her shot. “The only way to really beat COVID is for all of us collectively to work together for the greater good.” Scientists agree. Each infection — whether in an adult in Yemen or a kid in Kentucky — gives the virus another opportunity to mutate. Protecting a new, large chunk of the population anywhere in the world limits those opportunities.
22nd Nov 2021 - The Associated Press


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Nov 2021

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Pfizer to apply for EU authorization of its COVID pill on Friday

Pfizer plans to apply for a European authorisation of its experimental antiviral pill to treat COVID-19 on Friday, German weekly Wirtschaftswoche said, citing sources close to the European Medicines Agency (EMA) and the company. The paper also said that acting German health minister Jens Spahn plans to buy Pfizer's medicine. "The health ministry is in contact with Pfizer regarding a possible procurement of the antiviral drug Paxlovid," Wirtschaftswoche quoted a ministry's spokesperson as saying.
20th Nov 2021 - Reuters

China's BioKangtai begins first shipment of AstraZeneca's COVID-19 shot

AstraZeneca Plc's (AZN.L) COVID-19 vaccine partner in China, Shenzhen Kangtai Biological Products (BioKangtai) (300601.SZ), has begun its first shipment of the shot, sending more than four million doses to Indonesia, BioKangtai said on Friday. Including the first batch, BioKangtai plans to send over eight million doses of the China-made AstraZeneca shot, branded as KconecaVac, to Indonesia this month, Zhang Qian, general manager at BioKangtai's international affairs department, said in a video interview with local media.
20th Nov 2021 - Reuters

Market in China's Wuhan likely origin of COVID-19 outbreak - scientist

The first known COVID-19 case was a market vendor in the Chinese city of Wuhan, not an accountant who appeared to have no link to the market but whose case contributed to speculation the virus could have leaked from a lab, a U.S. researcher wrote in a commentary piece published on Thursday. The origin of the SARS-CoV-2 virus that causes COVID-19 remains a mystery and a major source of tension between China and the United States. The new analysis by the researcher does not provide a definitive answer to that question.
20th Nov 2021 - Reuters

Canada authorizes Pfizer Covid vaccine for ages 5-11

Canada on Friday became the latest country to authorize the Pfizer-BioNTech Covid-19 vaccine for children aged between five and 11-years-old. "After a thorough and independent scientific review of the evidence, the department has determined that the benefits of this vaccine for children between five and 11 years of age outweigh the risks," said an official statement from Health Canada. The decision follows an application by the companies submitted on October 18 after carrying out a clinical trial among thousands of children in this age group. The vaccine was found to be more than 90 percent effective at preventing Covid-19, and no serious side-effects were identified. It is dosed at 10 micrograms rather than the 30 micrograms used in older ages, and administered as two shots, three weeks apart.
20th Nov 2021 - FRANCE 24

Merck Covid pill backed for EU emergency use

The EU's drug watchdog on Friday backed Merck's anti-Covid pill for emergency use ahead of its formal authorisation and started reviewing Pfizer's antiviral treatment as cases soar across Europe. The two pills by the US pharma giants represent a potentially groundbreaking step in the fight against coronavirus as studies show they cut the risk of hospitalisation and death in high-risk patients. The European Medicines Agency (EMA) said that while the Merck pill was not yet approved, it had "issued advice" so that individual countries in the 27-nation EU could decide whether to use it in case of a surge in infections. "The medicine, which is currently not authorised in the EU, can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe Covid-19," the EMA said in a statement. "EMA issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorisation, for example in emergency use settings, in light of rising rates of infection and deaths due to Covid-19 across the EU."
20th Nov 2021 - RFI

CDC expands COVID booster jab eligibility to all US adults

The US Centers for Disease Control and Prevention (CDC) has expanded eligibility for COVID-19 booster jabs to all adults in the United States, move that paves the way for millions more Americans to receive additional protection against the virus. The CDC on Friday evening endorsed the advice of a health advisory panel, which earlier voted unanimously to recommend expanding booster eligibility to all Americans aged 18 and older who received their second dose of the Pfizer-BioNTech or Moderna vaccines at least six months earlier.
20th Nov 2021 - Aljazeera.com

Canada approves Pfizer-BioNTech jab for kids starting at age five

The vaccine is 90.7 percent effective at preventing COVID-19 in kids with no serious side effects, Health Canada said. Canada has approved the Pfizer-BioNTech coronavirus vaccine for children between the ages of five and 11. It’s the first jab to be approved for kids in that age group, Health Canada said on Friday, calling the move “a major milestone” in the fight against COVID-19. The vaccine was 90.7 percent effective at preventing COVID-19 in children five to 11 years of age, Health Canada said, and no serious side effects were identified. “After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks,” Health Canada said in a statement. Kids in Canada will receive two doses of the vaccine, at 10 micrograms each, to be taken three weeks apart. That is a lower dose than the 30 micrograms two-dose regimen authorised for people 12 years of age and older.
20th Nov 2021 - Aljazeera.com

Could this gene double your risk of dying from COVID-19?

Soon after the pandemic began, we knew that certain groups of people are more at risk of dying from COVID-19 than others. It was immediately clear that those with specific underlying health conditions such as diabetes and cardiovascular disease were at increased risk, but slowly it became evident that certain ethnic groups were also being disproportionately affected. Social factors have played an important role in why these groups have been more affected than others, but genetics may also play a part. Scientists at Oxford University have now identified a version of a gene that may be associated with doubling the risk of respiratory failure from COVID, and it could go some way to explaining why people from particular backgrounds are more likely to die from the virus. The study’s authors said that their work identifying the gene was extremely difficult because it wasn’t merely the presence of the gene they were looking for, but whether it was switched “on”, making it more high risk.
20th Nov 2021 - Al Jazeera English

How will the COVID pandemic affect flu season?

Countries in the Northern Hemisphere are facing an unpredictable winter as COVID-19 continues to spread during the flu season, experts have warned. Last year, when governments recommended a range of protective measures such as mask-wearing, social distancing and lockdowns to slow COVID-19 infections, the number of influenza cases dropped dramatically compared with the seasonal average. According to the European Centre for Disease Prevention and Control (ECDC) about 20 percent of the population catches the flu each year, but that figure fell by more than 99 percent in 2020-21. There were no hospitalised cases nor fatalities reported from influenza last season. Cases this year have remained low, according to the World Health Organization (WHO), but with COVID restrictions being lifted in many parts of the world, children back in school, and the coronavirus continuing to spread, experts are urging people to remain cautious. An uptick of influenza cases could burden health systems already facing difficulties due to outbreaks of COVID-19
20th Nov 2021 - Aljazeera.com

FDA official explains decision on 'simplified' booster shots

The U.S. government’s booster campaign got a lot simpler Friday after Food and Drug Administration officials authorized extra shots of Pfizer and Moderna COVID-19 vaccines for all adults. It replaces a complicated system in which eligibility was based on age, health conditions and other factors. “It’s simplified things, I think significantly over the situation that we had in place previously,” FDA’s vaccine chief Dr. Peter Marks told The Associated Press. The FDA action comes after months of debate among experts over whether everyone 18 and older should get an extra shot for protection.
20th Nov 2021 - The Associated Press

Research links COVID-19 in pregnancy with stillbirths

Pregnant women with COVID-19 face increased chances for stillbirths compared with uninfected women, and that risk spiked to four times higher after the delta variant emerged, new government data show. The federal Centers for Disease Control and Prevention released a report Friday that examined 1.2 million deliveries in 736 hospitals nationwide from March 2020 through September 2021. Stillbirths were rare overall, totaling 8,154 among all deliveries. But the researchers found that for women with COVID-19, about 1 in 80 deliveries resulted in stillbirth. Among the uninfected, it was 1 in 155. Among those with COVID-19, stillbirths were more common in people with chronic high blood pressure and other complications, including those in intensive care or on breathing machines.
20th Nov 2021 - The Associated Press

US opens COVID boosters to all adults, urges them for 50+

The U.S. on Friday opened COVID-19 booster shots to all adults and took the extra step of urging people 50 and older to seek one, aiming to ward off a winter surge as coronavirus cases rise even before millions of Americans travel for the holidays. Until now, Americans faced a confusing list of who was eligible for a booster that varied by age, their health and which kind of vaccine they got first. The Food and Drug Administration authorized changes to Pfizer and Moderna boosters to make it easier. Under the new rules, anyone 18 or older can choose either a Pfizer or Moderna booster six months after their last dose. For anyone who got the single-dose Johnson & Johnson vaccine, the wait already was just two months. And people can mix-and-match boosters from any company.
20th Nov 2021 - The Associated Press

Fauci overwhelmed by calls after journal published mistake over beagle experiments | TheHill

The nation's top infectious disease expert Anthony Fauci has been inundated with calls following a mistake in a scientific journal claiming that the National Institute of Allergy and Infectious Diseases (NIAID) was funding experimental research on beagles. The calls were so frequent that Fauci's assistant stopped answering the phone for two weeks in October, The Washington Post reported Friday. He received 3,600 phone calls in 36 hours. “The constant harassment in the form of ridiculous accusations and outright lies makes doing my job and that of my staff of fighting the covid-19 pandemic all the more difficult,” Fauci told the Post. “This attack on me, which clearly has political overtones to a nonpolitical scientist, I feel, is dangerous to the entire field of science and [shows] how people try to intimidate scientists.”
20th Nov 2021 - The Hill

Pfizer-BioNTech, Moderna Covid-19 Boosters for All Adults Backed by FDA, CDC

Booster shots from Pfizer Inc and partner BioNTech and Moderna Inc. MRNA will be available to all adults after the Centers for Disease Control and Prevention endorsed the extra doses for people at least six months after their second shot. The signoff Friday by CDC Director Rochelle Walensky will lead to a significant widening of the U.S. booster campaign that health officials hope will remove confusion and offer people more protection ahead of holiday gatherings and travel as new daily Covid-19 cases are beginning to rise again. “Booster shots have demonstrated the ability to safely increase people’s protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays,” Dr. Walensky said.
20th Nov 2021 - The Wall Street Journal

Merck’s Covid Pill Can Be Used to Treat Adults, EU Regulator Says

Merck & Co.’s antiviral pill for Covid-19 can be used to treat adults in the European Union, the bloc’s drug regulator said, giving countries another weapon to use as a fourth wave of the pandemic sweeps the continent. Merck’s Lagevrio pill, known generically as molnupiravir, is still under review and hasn’t been formally authorized for sale. But until then, it can be used to treat adults who don’t need oxygen therapy and face an increased risk of developing severe Covid, the European Medicines Agency’s human medicines committee said on Friday. National authorities may decide to use the pill in emergency settings “in light of rising rates of infection and deaths due to Covid-19 across the EU,” the regulator said. Austria imposed a nationwide lockdown on Friday, and German authorities said they wouldn’t rule out a similar move, as cases rise and intensive care facilities fill up.
20th Nov 2021 - Bloomberg

Delta variant dangerous during pregnancy, CDC reports say

Once the delta variant took hold in the United States, pregnant individuals and their fetuses or babies faced increased risks from coronavirus infections, according to two new reports released Friday by the Centers for Disease Control and Prevention. One report found that 15 pregnant patients died of covid-related causes between March 2020 and early October, including nine who died after delta became the most prominent strain. All but one of the women who died had underlying health conditions, and none had been fully vaccinated. The second report found that the risk of stillbirth increased about fourfold for women with covid-19 as delta surged. The reports’ authors emphasize the importance of preventive measures including vaccination, which the CDC recommends for pregnant people. Only about 30 percent of pregnant Americans are vaccinated, a rate far lower than the population as a whole.
20th Nov 2021 - The Washington Post

Hong Kong Approves Sinovac Vaccine for Children Ages 3-17

Hong Kong approved lowering the age of eligibility for the Covid-19 vaccine from China’s Sinovac Biotech Ltd. to three years old, down from 18 years old. The city’s Secretary for Food and Health said adolescents from 12-to-17 years will be accorded priority to receive the vaccine, “with a view to extending to children of a younger age group at a later stage,” according to a statement on Saturday. Experts serving on panels for the Centre for Health Protection had earlier backed the new age limit. The expansion of the eligible population comes as Hong Kong’s immunization campaign hits a wall. Vaccine hesitancy is ripe especially among the elderly population, many of whom refuse to even get one dose. Since the effort began in February, about 60% of residents have been fully vaccinated, according to Bloomberg’s Vaccine Tracker.
20th Nov 2021 - Bloomberg

EU recommends Merck COVID-19 pill for adults at risk of severe illness

The European Union's drug regulator on Friday advised that an experimental COVID-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening. The European Medicines Agency (EMA) said the pill, developed along with Ridgeback Biotherapeutics, should be taken twice a day for five days, but advised against use during pregnancy for in women who plan to get pregnant.
20th Nov 2021 - Reuters

U.S. expands COVID-19 booster eligibility to all adults

U.S. regulators expanded eligibility for booster shots of COVID-19 vaccines to all adults on Friday, allowing millions more Americans to get additional protection against the virus amid a recent rise in infections. The director of the Centers for Disease Control and Prevention, Rochelle Walensky, signed off on the expanded eligibility on Friday evening after the U.S. Food and Drug Administration broadened its authorization of booster doses to all adults who had received their second shot of either the Pfizer/BioNTech or Moderna Inc vaccine at least six months prior.
20th Nov 2021 - Reuters

Hong Kong Approves Sinovac Vaccine for Children Ages 3-17

The city’s Secretary for Food and Health said adolescents from 12-to-17 years will be accorded priority to receive the vaccine, “with a view to extending to children of a younger age group at a later stage,” according to a statement on Saturday. Experts serving on panels for the Centre for Health Protection had earlier backed the new age limit. The expansion of the eligible population comes as Hong Kong’s immunization campaign hits a wall. Vaccine hesitancy is ripe especially among the elderly population, many of whom refuse to even get one dose. Since the effort began in February, about 60% of residents have been fully vaccinated, according to Bloomberg’s Vaccine Tracker. That compares with over 80% in Singapore, its rival financial hub in Asia.
20th Nov 2021 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Nov 2021

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Canada to authorize use of Pfizer's COVID-19 vaccine for children -source

Canada will announce as expected on Friday it is authorizing the use of Pfizer Inc's COVID-19 vaccine for children aged 5 to 11, a government source said on Thursday. The decision will make it the first shot for young children in Canada. Officials had made clear for weeks that the decision would be favorable, noting that incidences of COVID-19 are now highest in those under 12. Prime Minister Justin Trudeau said last month that Ottawa had signed a deal with Pfizer to quickly receive 2.9 million doses of the vaccine once it was approved.
18th Nov 2021 - Reuters

‘Zero-Covid is not going to happen’: experts predict a steep rise in US cases this winter

A steep rise in Covid-19 cases in Europe should serve as a warning that the US could also see significant increases in coronavirus cases this winter, particularly in the nation’s colder regions, scientists say. However, there is more cause for optimism as America enters its second pandemic winter, even in the face of likely rises in cases. Evidence shows vaccine-conferred protection against hospitalization and death remains high several months after inoculation, vaccines for children older than five can reduce Covid transmission, and new antiviral medications hold the promise of making Covid-19 a treatable disease.
18th Nov 2021 - The Guardian

AstraZeneca's antibody drug over 80% effective at preventing Covid, trial shows

The data showed that patients given a single injection of the antibody treatment were 83% less likely to develop symptomatic cases of the coronavirus than participants who were given a placebo. Around 2% of the world’s population is thought to be at risk of not responding well to Covid-19 vaccines, according to AstraZeneca. In a separate trial, patients with mild-to-moderate Covid-19 who were given one dose of AZD7442 within three days of developing symptoms had their risk of developing severe disease reduced by 88%.
18th Nov 2021 - CNBC

Pfizer, U.S. ink $5.29 deal over possible COVID-19 treatment

The U.S. government will pay drugmaker Pfizer $5.29 billion for 10 million treatment courses of its potential COVID-19 treatment if regulators approve it. Pfizer asked the Food and Drug Administration on Tuesday to authorize the experimental pill, which has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The FDA is already reviewing a competing pill from Merck and will hold a public meeting on it later this month. The price for Pfizer’s potential treatment amounts to about $529 per course. The U.S. has already agreed to pay roughly $700 per course of Merck’s drug for about 1.7 million treatments.
18th Nov 2021 - The Independent

Moderna seeks U.S. authorization of COVID-19 booster shots for all adults

Moderna Inc said on Wednesday it had applied with the U.S. Food and Drug Administration for authorization of its COVID-19 booster vaccine for all adults aged 18 and older. The FDA has cleared booster shots of COVID-19 vaccines for people who are immunocompromised, those aged 65 and older and for individuals at high risk of severe disease or who are regularly exposed to the virus. Moderna is seeking authorization for a 50-microgram booster dose, half the strength of its original vaccine given in two shots about four weeks apart.
18th Nov 2021 - Reuters

UK study suggests Delta subvariant less likely to cause symptoms

A subvariant of Delta that is growing in Britain is less likely to lead to symptomatic COVID-19 infection, a coronavirus prevalence survey found, adding that overall cases had dropped from a peak in October. The Imperial College London REACT-1 study, released on Thursday, found that the subvariant, known as AY.4.2, had grown to be nearly 12% of samples sequenced, but only a third had "classic" COVID symptoms, compared with nearly a half of those with the currently dominant Delta lineage AY.4. Two-thirds of people with AY.4.2 had "any" symptom, compared with more than three-quarters with AY.4.
18th Nov 2021 - Reuters

Pfizer signs $5.3 billion U.S. deal to supply COVID-19 antiviral pills

Pfizer Inc said the U.S. government would pay $5.29 billion for 10 million courses of its experimental COVID-19 antiviral drug, as the country rushes to secure promising oral treatments for the disease. The deal is for around twice as many treatment courses as Merck & Co Inc has agreed to supply the United States under its contract. The price for the Pfizer pill is nearly 25%lower at roughly $530 per course, compared with about $700 for Merck's.
18th Nov 2021 - Reuters

AstraZeneca's preventative COVID-19 shot shown to work longer-term

AstraZeneca cemented its lead in bringing a preventative COVID-19 shot to market, saying its antibody cocktail offered 83% protection over six months, providing another possible weapon in the fight against the pandemic. The therapy, called AZD7442 or Evusheld, had previously been shown to confer 77% protection against symptomatic illness after three months, in an earlier readout of the late-stage PROVENT trial in August.
18th Nov 2021 - Reuters

EU assesses GSK-Vir COVID-19 antibody therapy for authorisation

European health regulator said on Thursday it was assessing a marketing authorisation application for GSK-Vir Biotechnology's, monoclonal antibody treatment for COVID-19 and could give its opinion within two months. The drug, sotrovimab, branded as Xevudy was already under a speedy review by the European Medicines Agency (EMA), and GSK's application makes the drug the fourth application currently under EU lenses for the treatment of COVID-19.
18th Nov 2021 - Reuters

Antibody protection after mild COVID-19 may not last; an estimated 100 mln people have had long COVID

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review. Antibody protection from mild COVID-19 may not last Nearly everyone who had a mild case of COVID-19 still has antibodies to the coronavirus a year later, but that might not protect them from new variants, a small study suggests. Among 43 Australians who dealt with mild COVID-19 early in the pandemic, 90% still had antibodies 12 months later.
18th Nov 2021 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Nov 2021

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Moderna seeks U.S. authorization of COVID-19 booster shots for all adults

Moderna Inc said on Wednesday it had applied with the U.S. Food and Drug Administration for authorization of its COVID-19 booster vaccine for all adults aged 18 and older. The FDA has cleared booster shots of COVID-19 vaccines for people who are immunocompromised, those aged 65 and older and for individuals at high risk of severe disease or who are regularly exposed to the virus. Moderna is seeking authorization for a 50-microgram booster dose, half the strength of its original vaccine given in two shots about four weeks apart. The filing comes a week after Pfizer Inc applied for a similar clearance for the booster doses of the vaccine it has developed with German partner BioNTech.
18th Nov 2021 - Yahoo News UK

Atrial fibrillation significantly increases a person’s risk of serious complications and death from COVID-19

A new study from researchers at Intermountain Healthcare in Salt Lake City finds that patients with atrial fibrillation, the most common type of heart arrhythmia in adults, are at significantly higher risk to experience serious complications from COVID-19 illness. The study found that patients with a history of atrial fibrillation who have COVID-19 illness are not only more likely to need hospitalization, ICU and ventilator support, but nearly 62% more likely to suffer a major cardiovascular event, such as a heart failure hospitalization, and 40% more likely to die than individuals who don’t have a history of atrial fibrillation.
17th Nov 2021 - EurekAlert!

FDA promises quick review of Pfizer booster for all adults, CDC meets Friday

The U.S. Food and Drug Administration (FDA) said on Tuesday it would review Pfizer Inc's request to authorize booster doses of COVID-19 vaccine in all adults "as expeditiously as possible," with the New York Times reporting that the regulatory nod could come as soon as Thursday.
17th Nov 2021 - Reuters

Pfizer files for U.S. authorization of promising COVID-19 antiviral pill

Pfizer Inc said on Tuesday it is seeking U.S. authorization of its experimental antiviral COVID-19 pill that cut the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial. Pfizer said it completed submission of its application for emergency use authorization of the drug, Paxlovid, with the U.S. Food and Drug Administration, including data from the drugmaker's clinical trial.
17th Nov 2021 - Reuters

Philippines approves emergency use of Novavax COVID-19 vaccine

The Philippines has approved the emergency use of a COVID-19 vaccine by Novavax Inc, its food and drug agency chief said on Wednesday, the ninth vaccine approved in the Southeast Asian country. The nanoparticle vaccine, under the brand name Covovax, will be manufactured by Serum Institute of India, and is approved for use on adults 18 and above, the agency's chief Rolando Enrique Domingo told a public briefing. Covovax, which had efficacy of 89.7% in clinical trials, will be administered in two doses not less than 21 days apart, Domingo added.
17th Nov 2021 - Reuters

EU regulator expects decision on Novavax COVID-19 shot in weeks

The European Union's drug regulator said on Wednesday it could decide on Novavax's COVID-19 vaccine approval "within weeks" if the data it has received from the drugmaker was sufficient to prove the shot's effectiveness. The protein-based vaccine, branded Nuvaxovid, has been under a rolling review since February, the European Medicines Agency (EMA) said. Such reviews allow for a speedy approval.
17th Nov 2021 - Reuters

Roche walks away from Atea partnership to develop COVID-19 pill

Roche Holding AG has ended a partnership with Atea Pharmaceuticals Inc to jointly develop a COVID-19 antiviral pill, the Swiss drugmaker said on Tuesday, a month after the drug failed to help patients in a small study. Boston-based Atea's shares fell 11% to $10.08 in extended trading, set to add to the 72% slump this year. Many companies are racing to develop an oral pill as it can be taken as an early at-home treatment to help prevent COVID-19 hospitalizations and deaths, a promising new weapon in the fight against the pandemic.
17th Nov 2021 - Reuters

U.S. secures GSK-Vir COVID-19 antibody therapy doses worth $1 bln

The United States has signed contracts worth about $1 billion for doses of the antibody-based COVID-19 treatment from Britain's GSK and U.S.-based Vir Biotechnology, as countries seek to secure promising options beyond vaccines. The drugmakers said on Wednesday the U.S. orders bring the total number of doses to be supplied to more than 750,000 globally, without specifying how many doses of the treatment, sotrovimab, the U.S. government had signed up for.
17th Nov 2021 - Reuters

COVID-19: More infectious variant of Delta virus accounts for 1 in 10 COVID cases in England

Professor Paul Elliott, director of the REACT programme at Imperial College London, said the strain "seems to be less symptomatic" than the original Delta virus - adding this is a "good thing" as it "may be spreading less far in distance" when people are coughing.
17th Nov 2021 - Sky News

Could this gene double your risk of dying from COVID-19?

Soon after the pandemic began, we knew that certain groups of people are more at risk of dying from COVID-19 than others. It was immediately clear that those with specific underlying health conditions such as diabetes and cardiovascular disease were at increased risk, but slowly it became evident that certain ethnic groups were also being disproportionately affected. Social factors have played an important role in why these groups have been more affected than others, but genetics may also play a part. Scientists at Oxford University have now identified a version of a gene that may be associated with doubling the risk of respiratory failure from COVID, and it could go some way to explaining why people from particular backgrounds are more likely to die from the virus. The study’s authors said that their work identifying the gene was extremely difficult because it wasn’t merely the presence of the gene they were looking for, but whether it was switched “on”, making it more high risk.
17th Nov 2021 - AlJazeera

GlaxoSmithKline and Vir finally score $1B supply deal for COVID antibody—6 months after FDA nod

It was a long time coming but GlaxoSmithKline and Vir Biotechnology have finally secured a supply deal with the United States for their COVID-19 antibody treatment—six months after it scored an FDA emergency authorization. The U.S. will pay $1 billion to expand access to sotrovimab throughout the country. While the green light for sotrovimab—known commercially as Xevudy—came in May, the therapy has been available in more than half of the states in the U.S., which were free to make separate deals to acquire it. GSK said it will supply the contracted doses by Dec. 17. There is an option for the U.S. to purchase additional doses by March 2022. GSK did not reveal how many doses are included in the agreement but said it has now secured contracts to sell more than 750,000 doses worldwide. Japan, Australia and Canada are among the countries that have inked supply deals for sovrotimab.
17th Nov 2021 - FiercePharma

Johnson and Johnson’s new vaccines leader talks Covid-19, pipeline plans, and ‘a golden opportunity’ for clinical trials

There’s a changing of the guard at Janssen, Johnson & Johnson’s vaccines division. In June, the company announced that Penny Heaton, formerly the founding CEO of the Bill and Melinda Gates Medical Research Institute, was joining Janssen as the global therapeutic area head for vaccines, taking over from Johan Van Hoof, who retires at the end of 2021. Heaton’s CV shows her chops. She also previously worked for Merck, Novartis, and Novavax, and earlier in her career at the Centers for Disease Control and Prevention. As she faces her first J&J Pharma Day on Wednesday — actually a two-day event for analysts — STAT caught up to Heaton to ask her about her plans for Janssen’s vaccines division. We discussed the company’s Covid-19 vaccine, made with an adenovirus 26 delivery system that is also used in its Ebola vaccine, which has been licensed in Europe. We also talked about Janssen’s promising vaccine to protect adults against respiratory syncytial virus or RSV, now in a Phase 3 clinical trial, and other things in its pipeline.
17th Nov 2021 - STAT News

With 128 Covid vaccines in clinical development, we don’t know if the approved/authorized ones are the best ones

Pfizer/BioNTech. Moderna. Johnson & Johnson. AstraZeneca. These are the marquee names that spring to mind when you think of the vaccine companies at the forefront of the global fight against Covid-19. And for good reason: together they have manufactured the majority of the estimated 7 billion-plus Covid vaccine doses administered to date around the world. But as regulators in the U.S., Europe, and around the world mull the most responsible way to expand vaccine eligibility to an even larger share of their populations — including to younger children, as the Food and Drug Administration (FDA) and Centers for Disease Control (CDC) have done this month by greenlighting Pfizer’s vaccine for kids 5 to 11 years of age — it’s time to confront an uncomfortable reality: The global health community still doesn’t know which of the hundreds of Covid vaccines currently in clinical and preclinical development are truly “the best.” That’s a shortcoming governments and the global health system need to address if they are to ensure that the next pandemic doesn’t knock the world on its heels to the extent the novel coronavirus has done.
17th Nov 2021 - STAT News

Pfizer agrees to allow generic versions of its COVID pill

Pharmaceutical giant Pfizer has signed a deal enabling the production and supply of its experimental COVID anti-viral drug in dozens of lower- and middle-income countries. The agreement between the US company and the UN-backed international public health group Medical Patent Pool (MPP) would allow producers to manufacture and supply generic versions of the drug in 95 countries without the threat of patent infringement.
16th Nov 2021 - Aljazeera.com


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 17th Nov 2021

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Pfizer Asks F.D.A. to Authorize Covid Pill For Unvaccinated People

Pfizer has applied to the Food and Drug Administration to authorize its antiviral pill to treat unvaccinated people with Covid-19 who are at high risk of becoming severely ill, the company said on Tuesday. The drug, which will be sold under the brand name Paxlovid, could become available within weeks if authorization is granted. It is meant to be dispensed by pharmacies and taken at home. Paxlovid is the second antiviral pill to show effectiveness against Covid, in a new class of treatments for the disease that are expected to reach far more patients than other drugs that are typically given by infusion.
16th Nov 2021 - The New York Times

Pfizer Submits Covid-19 Pill for FDA Authorization

Pfizer Inc. said it asked U.S. health regulators to authorize its oral Covid-19 drug for use in high-risk patients, putting the pill on a path that could make it available for people to take at home by the end of the year. Clearance from the U.S. Food and Drug Administration would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease. “There is an urgent need for lifesaving treatment options,” Pfizer Chief Executive Albert Bourla said Thursday. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”
16th Nov 2021 - The Wall Street Journal

Why Impact of 'Long Covid' Could Outlast the Pandemic

Millions of people who have gotten Covid-19 and survived are finding that a full recovery can be frustratingly elusive. Weeks or even months after seemingly recovering from even a mild case, many patients still confront a wide range of health problems. As researchers try to measure the duration and depth of what’s being called “long Covid,” specialized, post–acute Covid clinics are opening to handle the patients. The scale of the pandemic and persistence of some of Covid’s disabling effects mean the economic pain and drain on health resources could continue well after the contagion ends.
16th Nov 2021 - Bloomberg

NHS boss Amanda Pritchard reveals health service is preparing a yearly Covid booster programme

Amanda Pritchard said the NHS is putting plans in place for yearly booster jabs JCVI recommended booster programme should be extended to all over-40s Ms Pritchard urged people to take up vaccination invitations 'as soon as possible'
16th Nov 2021 - Daily Mail

Three doses of COVID-19 mRNA vaccination safe in high-risk populations

Earlier reports have suggested the high effectiveness of messenger ribonucleic acid (mRNA) coronavirus disease (COVID-19) vaccines at preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, their efficacy against mild COVID-19 disease appears to wane over time. Thus, the need for additional/booster vaccine doses is being contemplated. This retrospective study included adults within the Mayo Clinic Enterprise who were vaccinated with three doses of United States Food and Drug Administration (FDA)-approved mRNA-based COVID-19 vaccines from December 1, 2020, to October 17, 2021. Participants received the first two doses of BNT162b2 or mRNA-1273 according to the emergency use authorization (EUA) protocol. The study participants were administered a third dose of the same vaccine type as the original two doses at least 28 days after the second dose. All subjects were followed up for at least 14 days after their third vaccine dose.
16th Nov 2021 - News-Medical.Net

More than 10,000 Australians have filed coronavirus vaccine injury claims

Taxpayers are facing a hefty bill for rare but significant coronavirus vaccine injuries, with at least 10,000 people planning to claim under the federal government’s no-fault indemnity scheme. Services Australia is building an online portal, to be launched next month, for uncapped claims above $5000 from those who suffered injury and loss of income due to their COVID-19 vaccine, with compensation for medical costs and lost wages to be paid by the government.
16th Nov 2021 - Sydney Morning Herald

Researchers find way to filter coronavirus particles out of the air

A study by researchers suggests that air filters can remove almost all airborne traces of COVID-19. The findings by the University of Cambridge and Addenbrooke's Hospital could not only improve the safety of "surge wards" but also opens up the possibility of setting standards for cleaner air to reduce the risk of indoor transmission. With fears growing of another potential wave this winter, the discovery could allow hospitals to better manage their repurposed "surge wards" which can often lack the ability to change the air with a high frequency.
16th Nov 2021 - Sky News

Jabs have given us a tactical advantage over Covid-19 – squandering it now would be reckless in the extreme

Now the spectre of Christmas cancelled is raised, an attempt to jolt millions out of complacency and into action. In other European countries – notably Austria, Netherlands, France, Italy and Germany – Covid-19 infections are climbing. Here in Britain, we have relied on high vaccination rates to keep hospitalisations and deaths low, even when infections have spiked. Squandering that tactical advantage over Covid-19 would be reckless in the extreme. From next week, booster jabs will be offered to eight million over-40s. Third doses cut the risk of infection by more than 80 per cent. So far the middle-aged are not coming forward in the numbers needed. While three-quarters of eligible over-70s have had their booster, just half of those in their 50s have taken up the offer.
16th Nov 2021 - iNews

How food can help recovery from Covid-19

Eating advice for people recovering from Covid-19 is now available online. The Recovery Knowledge Hub, external, launched by the University of Plymouth, asks people about their current diet and offers tips and ideas to improve it. The hub is aimed at everyone who wants advice, from the public to professionals and it is free, said the university. "Eating the right diet is crucial to keep well physically and mentally, and a key part of recovery from Covid-19 is to make sure your diet is healthy," said Mary Hickson, professor in dietetics at the university.
16th Nov 2021 - BBC News

COVID-19: Boosters not only replenish immunity against transmission but lift it too, new data shows

These two types of protection - against transmission and against severe disease - are both very important, but they are also quite different. Just because a particular vaccine is good at one thing doesn't necessarily mean it's equally good at the other thing. Just because a particular vaccine's effectiveness at preventing transmission is waning doesn't necessarily mean its effectiveness at preventing serious disease is diminishing at the same rate. I say all of this not just because the two types of protection are often conflated (though they are) but because keeping this distinction under your hat is quite important when navigating all the data around COVID and vaccines.
16th Nov 2021 - Sky News

Moderna says EU to donate over 70 mln doses of its COVID-19 vaccine

Moderna Inc said it signed an agreement that enables European Union and European Economic Area countries to donate over 70 million doses of its COVID-19 vaccine to the COVAX vaccine sharing scheme for low-and-middle income countries.
16th Nov 2021 - Reuters

AstraZeneca-Oxford COVID-19 vaccine supply hits two billion doses

Two billion doses of the AstraZeneca-Oxford University COVID-19 vaccine have been supplied worldwide, the Anglo-Swedish drugmaker and its partner said on Tuesday, in just under a year since its first approval. The shot, which is the biggest contributor to the COVAX vaccine sharing scheme backed by the World Health Organization, is being made in 15 countries for supply to more than 170 countries, London-listed AstraZeneca and Oxford University said in a joint statement. AstraZeneca in June last year signed on India's Serum Institute, the world's biggest manufacturer of vaccines by volume, to help double the vaccine's manufacturing capacity to two billion doses.
16th Nov 2021 - Reuters

Pfizer to allow generic versions of its COVID pill in 95 countries

Pfizer Inc said it will allow generic manufacturers to supply its experimental antiviral COVID-19 pill to 95 low- and middle-income countries through a licensing agreement with international public health group Medicines Patent Pool (MPP). The voluntary licensing agreement between Pfizer and the MPP will allow the UN-backed group to grant sub-licences to qualified generic drug manufacturers to make their own versions of PF-07321332. Pfizer will sell the pills it manufactures under the brand name Paxlovid.
16th Nov 2021 - Reuters

Racial disparities in kids’ vaccinations are hard to track

The rollout of COVID-19 shots for elementary-age children has exposed another blind spot in the nation’s efforts to address pandemic inequalities: Health systems have released little data on the racial breakdown of youth vaccinations, and community leaders fear that Black and Latino kids are falling behind. Only a handful of states have made public data on COVID-19 vaccinations by race and age, and the federal Centers for Disease Control and Prevention does not compile racial breakdowns either. Despite the lack of hard data, public health officials and medical professionals are mindful of disparities and have been reaching out to communities of color to overcome vaccine hesitancy. That includes going into schools, messaging in other languages, deploying mobile vaccine units and emphasizing to skeptical parents that the shots are safe and powerfully effective.
16th Nov 2021 - The Associated Press

Pfizer, like Merck, inks deal to license COVID-19 pill and boost global supply

With its highly anticipated COVID-19 oral treatment seemingly on a fast track to approval, Pfizer already is lining it up to be manufactured as a generic by countries in need. Under an agreement with the Medicines Patent Pool (MPP), Pfizer will license Paxlovid to facilitate affordable global access. The deal will allow sub-licensees to supply 95 countries that account for 53% of the world's population, Pfizer said. The arrangement mirrors the one made by Merck and Ridgeback with the MPP three weeks ago, allowing for needy countries to manufacture those drugmakers' COVID-19 pill molnupiravir. Molnupiravir also is expected to be endorsed by the FDA in the coming weeks. Both deals are contingent upon regulatory authorizations or approvals. An FDA advisory group will meet on Nov. 30 to discuss Merck's application for molnupiravir.
16th Nov 2021 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 16th Nov 2021

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U.K. Expands Covid-19 Booster Program to People in Their 40s

The U.K. is expanding its Covid-19 booster program to younger people as the country seeks to head off another wave of infections this winter. A third vaccine dose will be available to people aged 40 to 49 starting six months after their second shot, the government said Monday. Previously, only those over 50 and other vulnerable groups were eligible. So far, more than 12 million people have received a booster. The government is also recommending a second shot of the Pfizer Inc.-BioNTech SE vaccine for 16 and 17-year-olds. That inoculation will be given at least 12 weeks after the initial dose or a Covid infection, whichever is later.
15th Nov 2021 - Bloomberg

Novavax: SK Bioscience Submits BLA For COVID-19 Vaccine Candidate, NVX-CoV2373, To South Korea' MFDS

Novavax Inc. (NVAX) said that SK bioscience has summited a biologics license application for NVX-CoV2373, the first protein-based COVID-19 vaccine candidate, to South Korea's Ministry of Food and Drug Safety. NVX-CoV2373 is Novavax' recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant. In collaboration with Novavax, SK bioscience initiated the rolling submission process for NVX-CoV2373 to South Korea's Ministry of Food and Drug Safety in April of this year. The completion of a BLA submission to the agency marks the final review stage for authorization of NVX-CoV2373 in Korea.
15th Nov 2021 - Business Insider

Spain's Hipra gets green light for Phase II COVID vaccine trials

Spain's medicines agency has authorised Catalonia-based pharmaceutical group Hipra to test a COVID-19 vaccine it is developing on more than 1,000 volunteers, Prime Minister Pedro Sanchez said on Monday. Hipra will carry out the so-called Phase II trial - the second stage of a three-round trial process - on volunteers at 10 hospitals around Spain, Sanchez said. Speaking at an event to present how European Union recovery funds will be channelled into health investments, Sanchez described the vaccine development as "extraordinary news".
15th Nov 2021 - Reuters

Why two emergency physicians’ kids took part in the Pfizer vaccine trials

Cue the collective sigh of relief from many parents across the country. While the Pfizer-BioNTech Covid-19 vaccine has been available for children ages 12 and up since mid-September, as of now 28 million even younger school-age children between the ages of 5 and 11 are eligible to receive it. As an emergency medicine physician and a parent, that reassures me. As a member of the global community, it gives me hope we’ll soon return to some level of normalcy. I acknowledge the personal decision of some parents who don’t want their kids to be vaccinated. Yet as someone whose own children were part of the vaccine’s clinical trials, I feel compelled to share the story of why my wife and I felt confident making that decision with them, and what vaccinating younger children will mean for the fate of the pandemic.
15th Nov 2021 - STAT News

8 lingering questions about the new Covid pills from Merck and Pfizer

The past two months have brought extremely good news in the fight against Covid-19. Two different oral treatments have proved effective at both preventing people newly diagnosed with Covid-19 from entering the hospital and from dying. “We’re accelerating our path out of this pandemic,” President Biden said after data on the second Covid pill became available. The wide availability of oral drugs could make Covid-19 less lethal, making it less risky for people to return to in-person work and to their normal lives. The first results, from Merck and Ridgeback Therapeutics, were released in October and will be considered by an advisory panel to the Food and Drug Administration in December. That could lead to an emergency use authorization in the U.S. by the end of the year. That drug, molnupiravir, reduced hospitalizations by 50% and prevented deaths entirely a large randomized clinical trial when it was given within five days of when symptoms began. The pill is given as a five-day course during which patients take a total of 40 pills.
15th Nov 2021 - STAT News

Non-White race tied to higher risk for COVID infection, severity

A US meta-analysis and systematic review of data on 4.3 million patients analyzed in 68 cohort and cross-sectional studies shows that, relative to White people, Black, Hispanic, and Asian populations were at higher risk for COVID-19 infection and admission to an intensive care unit (ICU) but were less likely to die of the disease. The study, published yesterday in JAMA Network Open, was designed to uncover the link between socioeconomic determinants of health and racial disparities in COVID-19 outcomes. A team led by University of California at San Diego researchers searched for COVID-19 studies that included data on race and rates of infection, disease severity, and socioeconomic status published from Jan 1, 2020, to Jan 6, 2021, well before the more transmissible Delta (B1617.2) variant was predominant in the United States.
12th Nov 2021 - CIDRAP

GlaxoSmithKline, Vir target emergency authorization for intramuscular COVID-19 antibody drug with new trial win

GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody drug sotrovimab already bears an FDA emergency use authorization (EUA) as an infusion. Now, the pair hopes to win the same status for an intramuscular formulation. The latest plan comes as a phase 3 trial showed sotrovimab, also known as Xevudy, delivered similar efficacy between intramuscular and intravenous administration routes in nonhospitalized mild to moderate COVID patients who are at high risk of disease progression. The IM administration group recorded a 2.7% rate of progression to hospitalization for over 24 hours or death through Day 29 of the trial versus 1.3% in the IV arm, the two companies reported Friday from the COMET-TAIL study. The adjusted difference of 1.07% falls within the noninferiority bar GSK and Vir previously set with the FDA.
12th Nov 2021 - FiercePharma

Late to the party: Europe on the verge of approving Roche and Celltrion antibodies for COVID

Nearly a full year after the U.S. gave Regeneron’s antibody cocktail for COVID-19 patients emergency authorization, Europe is on the verge of approving the monoclonal antibody duo. The European Medicines Agency's (EMA's) committee for human medicines also has recommended another antibody treatment for approval, Celltrion’s regdanvimab. The EMA's Committee for Medicinal Products for Human Use has passed the recommendations to the European Commission for approval. The Regeneron cocktail of casirivimab and imdevimab, which is marketed outside of the U.S. by Roche and known commercially as Ronapreve, is recommended for COVID-19 patients who do not require supplemental oxygen and are at risk to progress to a severe form of the disease. It also is recommended for use as post-exposure prophylaxis. While the recommendations cover all adults, they also include adolescents 12 years or older weighing at least 40 kilograms, or roughly 88 pounds.
12th Nov 2021 - FiercePharma


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

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Bahrain authorizes AstraZeneca's anti-COVID drug for emergency use

Bahrain has approved the emergency use of AstraZeneca's (AZN.L) anti-COVID drug Evusheld, the state news agency reported on Sunday. Bahrain has become the first country to authorize the drug, which will be limited to adults who suffer from immunodeficiency or who are taking immunosuppressants, as well as individuals with occupations that put them at risk of transmission, the news agency said.
15th Nov 2021 - Reuters

More than 10,000 COVID-19 booster breakthroughs - cause for concern?

The Pfizer vaccines were not evaluated for preventing infection, but rather symptomatic or severe disease and death. And when it comes to these statistics at least for now, the vaccines seem to be doing their job. The percentage of people testing positive for the virus has declined from an aveage of more than 5% to just 0.56%. And hospitalisations have gone down too, hitting only 200 people on Friday with 20% of the patients in only a mild condition.
13th Nov 2021 - The Jerusalem Post

Covaxin, India’s homegrown COVID jab, ‘highly efficacious’: Study

Covaxin, the first COVID-19 vaccine developed in India, is “highly efficacious” and presents no safety concerns, according to a study published in the medical journal Lancet. Covaxin gained emergency approval from the World Health Organization last week, the eighth jab to be given the green light by the health body. The vaccine has already been cleared for use in 17 countries. Known by the code BBV152, Covaxin is an inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The WHO has described it as “extremely suitable for low- and middle-income countries due to easy storage requirements”. Some of the other approved vaccines must be stored at very low temperatures, which throws up logistical and cost problems.
12th Nov 2021 - Al Jazeera English

The Valneva COVID-19 vaccine: Why it might be a game-changer

French pharmaceutical company Valneva is throwing its hat into the vaccine ring, but it has a vaccine with a difference. Rather than induce an immune response that targets just the spike protein of the coronavirus, the Valneva vaccine, also known as VLA2001, stimulates an immune response to the entire virus, and that might just give it an edge over its competitors. It is different in that it uses the tried and tested method of taking the whole of the coronavirus and inactivating it so that it can no longer cause illness. It then combines with an adjuvant, a substance that helps it enter human cells effectively.
12th Nov 2021 - Al Jazeera English

WHO eyes meeting to set guidelines on COVID-19 pills

World Health Organization (WHO) officials said on Friday they were hoping to convene a meeting soon to set guidelines on the use of COVID-19 antiviral pills, saying they offered "very attractive" new prospects for clinical care. Britain became the first country to approve one of the potentially game-changing pills earlier this month. Janet Diaz, the WHO's top official for clinical care responses, said that a meeting of its guidelines development group would consider the question of COVID pills in a forthcoming meeting in three weeks. Another WHO official Mike Ryan said preliminary findings on the pills was "very, very welcome", adding that a "careful process" was not required before the therapies should be expanded more broadly.
12th Nov 2021 - Reuters

GSK-Vir COVID-19 antibody works as shot in the arm as well as infusion

Britain's GSK and partner Vir said on Friday their antibody-based COVID-19 drug was shown in a trial to work as well when given as a shot in the arm awhen administered via the standard infusion, potentially offering more convenience. GSK said it would now speak to global regulators, including the U.S. Food and Drug Administration, about potential approval for the new method of administration, known as intramuscular injection, which can be carried out by family doctors and spare patients a trip to hospital.
12th Nov 2021 - Reuters

Patients with Covid history contributing to diabetes case burden, says hospital

Experts at the hospital said inflammatory reactions after Covid could include, hypoxia, weakness, weight loss, hair loss, myocarditis, thyroid and diabetes which is being reported as one of the most common diseases.
12th Nov 2021 - Hindustan Times


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

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Covid Pills May Save Lives, But They Won’t End the Pandemic

The promise of new Covid-19 pills from Pfizer Inc. and Merck & Co. gives rise to the hopeful question: Is this how the pandemic ends? The best answer anyone can muster is “maybe.” No matter how effective the antiviral pills are, it will be months before we can say we’re near the end. The pills have been shown in studies to substantially reduce the chances that a high-risk, unvaccinated person with Covid will need hospitalization. The results rightly raised hopes. Pfizer’s drug was 89% effective, and Merck’s succeeded in about 50% of patients—potentially powerful scientific breakthroughs
11th Nov 2021 - Bloomberg

EU regulator backs COVID-19 drugs from Regeneron-Roche, Celltrion

Europe's drug regulator has recommended two COVID-19 antibody therapies - one from American-Swiss partners Regeneron-Roche and another from South Korea's Celltrion, as the region builds up its defence against surging cases. Approval by the European Commission would mark the first for any COVID-19 treatment on the continent since Gilead's remdesivir last year. Reuters reported earlier this week that the European Medicines Agency's (EMA) endorsement of the two drugs was imminent.
11th Nov 2021 - Reuters

EU regulator endorses COVID-19 drugs from Regeneron-Roche, Celltrion

Europe's drug regulator has recommended two COVID-19 antibody therapies - one from American-Swiss partners Regeneron-Roche and another from South Korea's Celltrion, as the region builds up its defence against surging cases. Approval by the European Commission would mark the first for any COVID-19 treatment on the continent since Gilead's remdesivir last year. Reuters reported earlier this week that the European Medicines Agency's (EMA) endorsement of the two drugs was imminent
11th Nov 2021 - Reuters

India could approve Covid pill in matter of days

Antiviral drug Molnupiravir, used for treating mild to moderate Covid-19 infections, is set to enter the Indian markets within days, an official confirmed on Wednesday. Manufactured by US drug companies Merck, Sharp and Dohme, Molnupiravir is among the first proven drugs to effectively treat the viral contagion and was originally developed to treat flu. It can be taken as a pill instead of injection or intravenous administration. It could likely enter the Indian pharmaceutical markets “within days” after receiving Emergency Use Authorisation, Dr Ram Vishwakarma,
11th Nov 2021 - The Independent

Moderna COVID-19 vaccine patent dispute headed to court, U.S. NIH head says

U.S. National Institutes of Health scientists played "a major role" in developing Moderna Inc's COVID-19 vaccine and the agency intends to defend its claim as co-owner of patents on the shot, NIH Director Dr. Francis Collins told Reuters on Wednesday. In a story first reported by the New York Times on Tuesday, Moderna excluded three NIH scientists as co-inventors of a central patent for the company's multibillion-dollar COVID-19 vaccine in its application filed in July.
11th Nov 2021 - Reuters

Moderna applies for COVID-19 booster shot approval from Japan's health ministry -NHK

Moderna Inc applied for approval from Japan's health ministry on Wednesday to use their COVID-19 vaccines for booster shots, broadcaster NHK reported on Thursday. Japan plans to start administering booster shots from December this year, and has already approved the use of Pfizer COVID-19 vaccines for a third round of vaccinations on Thursday. If approved, Moderna's vaccine would become the second to be approved for booster shots in Japan.
11th Nov 2021 - Reuters

Ellume's COVID-19 home test recall most serious, FDA says

The U.S. Food and Drug Administration classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker removed some of its tests from the market last month. Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall. A 'false positive' indicates that a person has the virus when they actually do not.
11th Nov 2021 - Reuters

UK researchers identify T-cell targets for future COVID vaccines

British researchers said on Wednesday they had identified proteins in the coronavirus that are recognised by T-cells of people who are exposed to the virus but resist infection, possibly providing a new target for vaccine developers. Immunity against COVID-19 is a complex picture, and while there is evidence of waning antibody levels six months after vaccination, T-cells are also believed to play a vital role in providing protection. The University College London (UCL) researchers examined 731 health workers in two London hospitals during the first wave of the COVID-19 pandemic, and found that many had not tested positive despite likely exposure to the original coronavirus.
11th Nov 2021 - Reuters

Moderna offers COVID-19 shot at $7 to African Union - Africa CDC head

Moderna Inc has offered to sell its COVID-19 vaccines to the African Union at $7 a shot, head of the Africa Centres for Disease Control John Nkengasong said on Thursday, half the price paid by the United States earlier in the year. It is also a substantial discount to what other buyers like the European Union have agreed this year, part of a broader trend for drugmakers to sell at lower prices to lower income countries. "I am happy to say that a dose of the Moderna vaccine will be $7. That is what is being offered to us," Nkengasong told a weekly virtual media briefing.
11th Nov 2021 - Reuters

Israel pandemic advisory panel backs COVID vaccine for young children

Israel's pandemic advisory board on Wednesday backed administering Pfizer's and BioNTech's COVID-19 vaccine to children age 5-11, health officials said, as a fourth wave of infections subsides nationwide. The Health Ministry is widely expected to accept the panel's recommendation and begin rolling out the shots this month. The U.S. Food and Drug Administration has granted emergency use authorization of the vaccine for the age group at a 10-microgram dose.
11th Nov 2021 - Reuters

Diabetes problem makes Africa more vulernable to COVID-19 death, says WHO

Death rates from COVID-19 infections are much higher in patients with diabetes in Africa, where the number of people with diabetes is growing rapidly, the World Health Organization said on Thursday. A WHO analysis of data from 13 African countries found a 10.2% case fatality rate in COVID-19 patients with diabetes, compared with 2.5% for COVID-19 patients overall. "COVID-19 is delivering a clear message: fighting the diabetes epidemic in Africa is in many ways as critical as the battle against the current pandemic," said Matshidiso Moeti, WHO Regional Director for Africa, in a statement.
11th Nov 2021 - Reuters

Sleep apnea linked to COVID-19 outcomes

Sleep apnea tied to severe COVID-19 - The risk of severe illness from COVID-19 is higher in people with obstructive sleep apnea and other breathing problems that cause oxygen levels to drop during sleep, researchers say. They tracked 5,402 adults with these problems and found that roughly a third of them eventually tested posted for the coronavirus. While periodic episodes of not-breathing while asleep - leading to low oxygen levels, or hypoxia - did not increase people's chances of being infected, sleep-related hypoxia did increase infected patients' odds of needing to be hospitalized or dying from COVID-19, Drs. Cinthya Pena Orbea and Reena Mehra of the Cleveland Clinic and colleagues reported on Wednesday in JAMA Network Open. It is not clear if treatments that improve sleep apnea, such as CPAP machines that push air into patients' airways during sleep, would also reduce the risk of severe COVID-19, said Pena Orbea and Mehra.
11th Nov 2021 - Reuters

EU authorizes 2 medicines for people at risk of severe COVID

The European Medicines Agency has recommended the authorization of two new medicines against the coronavirus for people at risk of severe disease. In a statement on Thursday, the EU drug regulator said it had concluded that the monoclonal antibody treatments — a combination of casirivimab and imdevimab, and the drug regdanvimab — have both been proven to significantly reduce the risk of hospitalization and death in patients vulnerable to serious COVID-19. The EMA described the safety profile of both medicines as “favorable,” and said that despite a small number of side effects, “the medicines’ benefits are greater than their risks.” The drug combination of casirivimab and imdevimab is made by Roche; it was granted an emergency use license by the U.S. Food and Drug Administration last November.
11th Nov 2021 - The Associated Press

Merck inks yet another $1B-plus supply deal for COVID pill, this time with Japan

Merck & Co.'s positive data for oral COVID-19 antiviral molnupiravir continue to pay off in a big way. Wednesday, just a day after unveiling a $1 billion sale order to the U.S., the company disclosed another major supply deal. Japan has agreed to pay Merck and partner Ridgeback Therapeutics $1.2 billion for 1.6 million courses of the drug, or $750 per course. The deal is contingent on the antiviral winning an authorization or approval from Japan’s Pharmaceuticals and Medical Devices Agency. The deal comes a day after Merck said the U.S. government agreed to purchase another 1.4 million courses of the drug for $1 billion. Together with an earlier purchase, the order brings the United States' total supply purchase to 3.1 million courses at a cost of $2.2 billion.
11th Nov 2021 - FiercePharma


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

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Next generation of Covid vaccines should target different part of virus, study says

A vaccine targeting Covid's replication proteins could knock all coronaviruses. Study found some NHS staff who tested negative had T cells against the virus. Current vaccines mainly target the spike protein to trigger antibody response
10th Nov 2021 - Daily Mail

Pfizer, BioNTech Ask FDA to Expand Covid-19 Booster Use to All Adults

Pfizer Inc. and partner BioNTech asked U.S. health regulators to expand the authorization of their Covid-19 booster to people as young as 18 years old, as the government explores expanding access to extra doses. The application opens the door for authorization of the extra dose potentially before the end of the year, which could provide millions of people with another layer of security as winter drives many indoors where the risk of transmission is higher. The Food and Drug Administration in September cleared a third dose of the Pfizer-BioNTech vaccine for adults who are 65 years and older or are at risk of severe disease and death, including because of their jobs or where they live.
10th Nov 2021 - The Wall Street Journal

Two Million Ellume Covid Tests Recalled on False Positive Risk

Ellume Ltd. is recalling 2.2 million at-home Covid-19 tests because they risk returning false positives, the U.S. Food and Drug Administration said. The regulator classified the action on Wednesday as a class I recall, the most serious kind, saying it has received 35 reports of false positives from the test made by the Australian company. Incorrect results could lead a person to wrongly receive Covid-19 treatments or isolate when they don’t need to, the FDA said. “The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false positive result,” a company spokesperson said in an email. “We have and will continue to work diligently to ensure test accuracy, in all cases.”
10th Nov 2021 - Bloomberg

U.S. Spending $650 Million to Expand Rapid Confirmatory Testing

The U.S. will spend $650 million to increase production and access to rapid diagnostic tests that can confirm the results of at-home screening, part of an effort to quickly identify and treat people with Covid-19. Peope who buy over-the-counter rapid antigen tests at pharmacies may need confirmatory testing to verify the accuracy of the result, the U.S. Department of Health and Human Services said Wednesday in a statement. The funds will help ensure such tests are readily available across the country and can provide results quickly, the agency said. The investment follows the Biden administration’s commitment of more than $3 billion for rapid home tests that may need confirmation. The earlier funding aimed to quadruple the amount of rapid home tests available in the U.S. by December, to about 200 million a month.
10th Nov 2021 - Bloomberg

French company Valneva wins deal with European Commission over COVID-19 vaccines

French vaccines company Valneva's share price jumped more than 20% on Wednesday after it won European Commission approval for a deal under which it would supply up to 60 million doses of its COVID-19 vaccine candidate over two years. The eighth such deal by the European Union's executive body in the fight against rising infections is a welcome boost for Valneva as it negotiates what has been a bumpy road for its COVID-19 vaccine. "The Valneva vaccine adds another option to our broad portfolio, once it is proven to be safe and effective by the European Medicines Agency (EMA)," EU health commissioner Stella Kyriakides said.
10th Nov 2021 - Reuters

Israeli MRI study finds heart damage from COVID-19 vaccine is rare and mild

A study conducted by Beilinson Hospital in Petah Tikva, using a detailed scanning technique to examine patients with symptoms of a heart muscle condition after receiving a COVID-19 vaccine, found that damage was rare, mild, and expected to heal. The study used cardiac magnetic resonance imaging on patients diagnosed with myocarditis, a weakening of the heart muscles that has been found in a few patients after they were inoculated. A link has been seen in recent months between coronavirus vaccines using mRNA technology and very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart).
10th Nov 2021 - The Times of Israel

Pfizer asks FDA for broader authorization of vaccine booster

Pfizer and its German partner, BioNTech, on Tuesday asked the Food and Drug Administration to authorize a booster dose of its coronavirus vaccine for people 18 and older. The FDA could clear the request by the end of the month, according to health officials who spoke on the condition of anonymity because they were not authorized to discuss the issue. The officials are concerned about studies showing waning vaccine protection, as well as increased infections in parts of the United States. Currently, the government recommends the Pfizer-BioNTech booster vaccine for people 65 and older and those 18 to 64 who are at high risk of covid-19, the disease caused by the virus, because of underlying medical conditions or potential exposures at work or in their living situation.
10th Nov 2021 - The Washington Post

COVID-19 tests may be more accurate in the afternoon

A new study finds that the accuracy of reverse transcription-polymerase chain reaction (RT-PCR) COVID-19 tests follows a daily pattern. The highest number of accurate positive results occur with midafternoon tests, while evening tests increase the number of false positives. The study also suggests that midafternoon is the time of day at which both symptomatic and asymptomatic individuals are most likely to pass on the SARS-CoV-2 virus to others.
10th Nov 2021 - Medical News Today

Germany recommends only Biontech/Pfizer vaccine for under-30s

Panel recommends only Biontech/Pfizer for under-30s. Makes similar recommendation for pregnant women. More heart inflammation cases with Moderna jab-data. Germany sees record number of COVID cases for third day
10th Nov 2021 - Reuters

Vietnam approves India's COVID-19 vaccine Covaxin

Vietnam has approved India's Covaxin vaccine for emergency use, the ninth to be endorsed in the country, the country's health ministry said on Wednesday. The government said in July it was seeking to secure 15 million doses of the Covaxin vaccine made by Bharat Biotech.
10th Nov 2021 - Reuters

BioNTech CEO says new COVID pills unlikely to dent vaccination uptake

The Chief Executive of COVID-19 vaccine pioneer BioNTech said he does not expect for now that new oral treatments against the viral infection would considerably reduce demand for vaccines. Oral antiviral pills from Merck & Co and Pfizer Inc have been shown to significantly blunt the worst outcomes of COVID-19. I really don’t believe that it will have a huge impact on the vaccination rate in future but we have to monitor the field," BioNTech CEO Ugur Sahin told an analyst call
10th Nov 2021 - Reuters

Pfizer seeks FDA nod for COVID vaccine boosters for U.S. adults

Pfizer Inc and BioNTech on Tuesday requested the U.S. Food and Drug Administration (FDA) to authorize booster doses of their COVID-19 vaccine in all adults, presenting recent data showing the shot would help prevent disease across ages. Over the past several months, the FDA has authorized Pfizer's boosters for people who are immunocompromised, those who are aged 65 and above, all people at high risk of severe disease, and people who are regularly exposed to the virus.
10th Nov 2021 - Reuters

EU to decide on Moderna's COVID-19 shot for younger kids in two months

The European Union's drug regulator expects to decide in about two months on whether to allow the use of Moderna's COVID-19 vaccine in children aged six to 11 years, it said on Wednesday, after the U.S. drugmaker sought approval. "The current timeline for evaluation foresees an opinion in approximately 2 months, unless supplementary information or analysis is needed," the European Medicines Agency (EMA) said in a statement.
10th Nov 2021 - Reuters

Long COVID symptoms may have causes other than SARS-CoV-2

A French study finds that, of 20 persistent physical symptoms reported by adults who said they had recovered from COVID-19, only 1 was linked to SARS-CoV-2 infection, as indicated by the presence of antibodies to the virus. The researchers, however, said that the results don't discount the presence of symptoms but rather underscore the importance of considering all possible causes in addition to COVID-19, such as other diseases, anxiety, or deconditioning related to the pandemic but not the virus itself. The study, published yesterday in JAMA Internal Medicine, involved analysis of blood samples from 26,823 adult participants who reported recovering from COVID-19.
10th Nov 2021 - CIDRAP

Moderna, U.S. clash in patent dispute over origins of COVID-19 vaccine: report

The public/private partnership between the U.S. government and Moderna to quickly develop a COVID-19 vaccine has been lauded as a feel-good success story—and a blueprint for future health crises. But less than a year after Moderna gained FDA authorization for its vaccine, its marriage with the feds is on the rocks. The company has done little appease the Biden administration’s call to make the vaccine available to poor countries, and now a much bigger battle over patent rights is brewing, The New York Times reports. The issue surrounds a July filing by Moderna with the U.S. Patent and Trademark Office which claims that it invented the vaccine. Meanwhile, the NIH says that three of its scientists created key elements of the shot.
10th Nov 2021 - Fierce Pharma

AstraZeneca creates unit to handle its COVID-19 vaccines, antibody treatments

As AstraZeneca suffered a series of missteps in the development, manufacture and distribution of its COVID-19 vaccine, other companies surged ahead in the race to provide shots to the world. Was AstraZeneca ill equipped for the monumental task? With the creation of a new unit responsible for COVID-19 treatments, including vaccines and antibodies, the company is attempting to better manage its response to the pandemic. Iskra Reic, a senior executive who heads up the company’s operations in Europe and Canada, will take control of the division, allowing CEO Pascal Soriot to manage the company’s bread-and-butter business. The new unit will have R&D, manufacturing, commercial and medical branches.
10th Nov 2021 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 10th Nov 2021

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Pfizer to apply for COVID vaccine use in Brazil for children 5-11 years

Pfizer Inc plans to seek Brazil's authorization to use its COVID-19 vaccine in children aged 5 to 11 years, the country's health regulator Anvisa said on Tuesday after a meeting with the U.S. company. Pfizer representatives met with Anvisa to present technical data ahead of a formal submission of its request, the regulator said in a statement. The dose for children aged 5 to 11 years will be lower than the dose for children over the age of 12 due to a new formula developed by the company, Anvisa said.
10th Nov 2021 - Reuters

U.S. government to buy $1 billion worth of Merck's COVID-19 pill

The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc and partner Ridgeback Biotherapeutics, the companies said on Tuesday. The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more. That brings the total secured courses to 3.1 million and worth $2.2 billion. Merck said the government has the right to buy 2 million more courses as part of the contract.
9th Nov 2021 - Reuters

EXCLUSIVE Amid spike in cases, EU to shortly approve first COVID antibody drugs - sources

The European Union drugs regulator is set to authorise the use of two monoclonal antibodies to treat COVID-19 patients in coming days, two EU sources told Reuters, in its first approvals of such therapies.
9th Nov 2021 - Reuters on MSN.com

Bangladesh's Beximco to sell first generic version of Merck COVID-19 pill

A Bangladeshi drugmaker will soon begin selling the world's first generic version of Merck's COVID-19 pill, molnupiravir, which has been touted as a potential game-changer in the fight against the pandemic. Beximco Pharmaceuticals will first sell generic molnupiravir in Bangladesh before considering exports based on global regulatory approvals, it said on Tuesday. The generic version has received emergency use authorisation from Bangladesh's drug regulators.
9th Nov 2021 - Reuters

Covid-19 drove deaths up 16% in OECD countries and hit mental health, too, report finds

The Covid-19 pandemic caused a 16% rise in expected deaths among the 38 members of the Organization for Economic Cooperation and Development, hitting overall life expectancy in 24 out of 30 members, the organization said Tuesday. Life expectancy fell the most in Spain and the United States, the group said, with the United States losing 1.6 years of life per capita on average over the year and a half of the pandemic so far, and Spain losing 1.5 years, the OECD said. "COVID 19 contributed, directly and indirectly, to a 16% increase in the expected number of deaths in 2020 and the first half of 2021 across OECD countries," the group said in its report.
9th Nov 2021 - CNN

COVID-19: Pfizer antiviral pill could be available 'early in 2022' if approved

An antiviral pill to treat COVID-19 should - subject to regulatory approval - be available early next year, the UK boss of Pfizer has told Sky News. The US drugs giant announced last week that the pill had been shown to cut the risk of hospitalisation or death from the virus by 89% and Britain has already ordered 250,000 courses of the treatment.
9th Nov 2021 - Sky News

India to buy 10 mln doses of Zydus Cadila's COVID-19 shot at about $4 each

French health authorities said on Monday the number of people hospitalised because of COVID-19 went up by 156 over the past 24 hours, the highest daily rise since Aug. 23, to reach a one-month peak of 6,865. The number of patients in intensive care units (ICUs) for the disease increased by 40 to 1,141, a ninth rise in 10 days. President Emmanuel Macron will speak to the nation on Tuesday about the resurgence of COVID-19 infections as well as his economic reform programme
9th Nov 2021 - Reuters India

Analysis: COVID-19 pills are coming, but no substitute for vaccines, disease experts say

Oral antiviral pills from Merck & Co and Pfizer Inc have been shown to significantly blunt the worst outcomes of COVID-19 if taken early enough, but doctors warn vaccine hesitant people not to confuse the benefit of the treatments with prevention afforded by vaccines. While 72% of American adults have gotten a first shot of the vaccine, according to a Kaiser Family Foundation poll, the pace of vaccination has slowed, as political partisanship in the United States divides views on the value and safety of vaccines against the coronavirus.
9th Nov 2021 - Reuters

AstraZeneca's COVID-19 antibody cocktail clears first step for registration in Australia

AstraZeneca's antibody cocktail against COVID-19 received its first nod for registration in Australia, the country's medical regulatory body said on Tuesday. The Therapeutic Goods Administration said it granted provisional determination to the Anglo-Swedish drugmaker last week for its antibody cocktail, EVUSHELD, the first protective shot other than vaccines against COVID-19. The regulator said the provisional determination is the first step in the process, adding that it now expects AstraZeneca to submit an application for provisional registration shortly.
9th Nov 2021 - Reuters

Amid spike in cases, EU to shortly approve first COVID antibody drugs - sources

EMA to approve Regeneron-Roche cocktail of monoclonal antibodies. EU agency to authorise also Celltrion's antibody therapy. Full marketing authorisations expected this week - source
9th Nov 2021 - Reuters

U.S. FDA lifts clinical hold on Inovio's COVID-19 vaccine trial

Inovio Pharmaceuticals Inc said on Tuesday the U.S. Food and Drug Administration (FDA) had lifted a partial clinical hold on late-stage trial of its COVID-19 vaccine within the country. Inovio said it now has the authorization to proceed with the trial after 14 months, sending its shares up 4.6% before the bell. The FDA last year in September put the final-stage trial on hold as it sought more information from the company, including details on a delivery device used to inject genetic material into cells.
9th Nov 2021 - Reuters

French health authority advises against Moderna COVID-19 vaccine for under 30s

France's public health authority has recommended people under 30 be given Pfizer's Comirnaty COVID-19 vaccine when available instead of Moderna Inc's Spikevax jab, which carried comparatively higher risks of heart-related problems. The Haute Autorite de Sante, which does not have legal power to ban or licence drugs but acts as an advisor to the French health sector, cited "very rare" risks linked to Myocarditis, a heart disease, that had shown up in recent data on the Moderna vaccine and in a French study published on Monday.
9th Nov 2021 - Reuters

U.S. government to buy $1 billion more worth of Merck's COVID-19 pill

The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc (MRK.N) and partner Ridgeback Biotherapeutics, the companies said on Tuesday. The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more. That brings the total secured courses to 3.1 million and worth $2.2 billion. Merck said the government has the right to buy 2 million more courses as part of the contract
9th Nov 2021 - Reuters

Australia's NSW says unvaccinated 16 times more likely to die from COVID-19

Unvaccinated people are 16 times more likely to end up in intensive care units or die from COVID-19, Australia's New South Wales state said in a report, with officials urging people to get inoculated as Australia begins to live with the coronavirus. The data from New South Wales (NSW) health department out late on Monday showed only 11% of people out of 412 who died from the Delta outbreak over four months through early October were fully vaccinated. The average age of those deaths was 82. Only around 3% of people in intensive care units had two doses, while more than 63% of the 61,800 cases detected between June 16 and Oct. 7 were unvaccinated.
9th Nov 2021 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 9th Nov 2021

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'This is far worse than January – the vaccine hasn't saved us this time'

“We should all be rated inadequate.” The call HSJ received on Sunday lunchtime from one of the most respected chief executives in the NHS carried an air of desperation.
8th Nov 2021 - Health Service Journal

PM urges people to take booster vaccine with more than 10 million having extra jab

Boris Johnson has urged people to get their booster vaccine as it emerged more than 10 million people have had the top-up jab. Government figures showed a combined total of 10,062,704 booster and third doses have been delivered with a day-on-day rise of 409,663. The Prime Minister tweeted : “An amazing 10 million people across the UK have already come forward for their booster. “We know vaccine immunity wanes over time, so boosters are vital in keeping you and your loved ones protected through the winter.
8th Nov 2021 - Evening Standard

Indonesia reviewing Merck COVID-19 pill, up to 1 mln doses targeted

Indonesia is reviewing a COVID-19 experimental antiviral pill produced by Merck & Co Inc for domestic use, its food and drug agency chief said on Monday, ahead of a possible purchase of up to 1 million doses next month. Britain is the first country to have approved the pill, named molnupiravir, which Merck last month said halved the chance of hospitalisation or death in patients at risk for severe illness. The United States, Malaysia, South Korea, Singapore, Thailand and the Philippines are among countries interested in buying molnupiravir.
8th Nov 2021 - Reuters

Pfizer could seek broad clearance for COVID-19 vaccine boosters this week - Washington Post

Pfizer and German partner BioNTech are expected to seek authorization for their COVID-19 vaccine booster shot for people aged 18 and above as soon as this week, Washington Post reported on Monday, citing officials familiar with the situation. The U.S. Food and Drug Administration (FDA) in September authorized the extra shot for those aged 65 and above, people at high risk of severe disease, and others regularly exposed to the virus.
8th Nov 2021 - Reuters

Covid-19 and pools, lakes, beaches: Is it safe to swim?

Health agencies have stated that the coronavirus cannot be transmitted through water. However, when at the beach and public pools – especially in indoor settings – you still need to exercise Covid protocols. This is because infected people can still pass on the virus through respiratory droplets or aerosols.
8th Nov 2021 - News24

What's behind the recent rise in Covid-19 deaths in S'pore? Here are some facts you may not know

Every death means the passing of a loved one - a father, mother, brother or sister - a relative or a friend. Yet, as Singapore transits to treating Covid-19 as an endemic disease, we need to speak frankly about deaths from the disease. The commentary by Professor Teo Yik Ying in The Straits Times on Aug 13 presented the possibility that as Singapore opens up, just like the United States, Israel, Britain and many European countries have done, the number of deaths here will go up, especially among the unvaccinated, as it has done elsewhere. Since then, the overall national vaccination rate has risen to 86 per cent. Vaccination rates among seniors have also increased substantially, making Singapore one of the most highly vaccinated countries in the world. We have also rolled out vaccine boosters, which have strengthened the protection against severe disease by at least 10 times, on top of the protection conferred by two doses.
8th Nov 2021 - The Straits Times

A win for health security

What is inside a tube can be the matter of life and death. Scientists carefully transfer each patient's sample into a microplate and put it in an automated box-shaped extraction instrument. After processing it for 10 minutes, it isolates ribonucleic acid (RNA) from coronavirus cells for an RT-PCR test. The coronavirus looks like a spiky ball. Many structural proteins surround its RNA, which houses genes. After health workers swab samples, they send them to scientists. RT-PCR testing looks at the genetic code of the virus by extracting and then amplifying it until SARS-CoV-2 is detectable. In the past, RNA extraction kits were imported, but the coronavirus pandemic has led to an increase in demand and price surges. But for the first time, the National Science and Technology Development Agency (NSTDA) has unveiled homegrown RNA extraction kits for commercial use.
8th Nov 2021 - Bangkok Post

Regeneron says antibody cocktail reduces risk of contracting Covid by 80% for at least 8 MONTHS

Regeneron says its antibody cocktail REGEN-COV reduces the risk of contracting COVID-19 by 81.6% two to eight months after it is administered. During this period, seven people in the treatment group developed Covid compared to 38 in the placebo group. None of the people given the cocktail were hospitalized with the virus compared to five who received a placebo. The drug was authorized last year as a treatment for COVID-19 but has since been expanded so it can be used as a prophylactic
8th Nov 2021 - Daily Mail

What we know about Pfizer’s ‘first of its kind’ Covid-19 antiviral pill What we know about Pfizer’s ‘first of its kind’ Covid-19 antiviral pill

PFIZER’S experimental Covid-19 pill was found to significantly reduce the risk of hospitalisation or death by 89%, in high-risk adults who have been exposed to the virus. The company announced at the weekend that, based on an interim analysis of Phase two and three clinical trials, the pill could be prescribed as an at-home treatment to help reduce illness severity, hospitalisations, and deaths. The drug, Paxlovid, is taken orally as soon as the first symptoms of Covid-19 appear, to avoid serious forms of the illness or hospitalisation. “If approved or authorised, Paxlovid, which originated in Pfizer’s laboratories, would be the first oral antiviral of its kind, a specifically designed Sars-CoV-2-3CL protease inhibitor,” said the company in a press release.
8th Nov 2021 - iol.co.za

Regeneron's antibody cocktail can protect against COVID-19 for up to 8 months, giving hope to the immunocompromised

People with compromised immune systems who are unable to develop adequate responses to vaccines may soon have an option to protect against COVID-19. A phase 3 trial of Regeneron’s antibody cocktail showed the treatment reduced the risk of infection by 81.6% over a period of two to eight months. Results previously reported in the New England Journal of Medicine from the same trial showed that REGEN-COV reduced the risk of infection by 81.4% during the first month after administration. “These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines, including people who are immunocompromised,” Myron Cohen, M.D., a University of North Carolina professor who leads the monoclonal antibody efforts for the NIH-sponsored COVID prevention network, said in a statement.
8th Nov 2021 - FiercePharma

Not all Covid waves look the same. Here’s a snapshot of the Delta surge

At first, Joyce Dombrouski thought it might just be some kind of blip. Maybe it was Montana’s summer tourists. But then, at one point this August, St. Patrick Hospital in Missoula had 30-plus Covid inpatients — “and we thought 30, a year ago, was a horrific number,” said Dombrouski, the chief executive of Providence Montana. It just kept growing. Three or four admissions a day, then five or six, then seven. The hospital was nearing capacity. There were more Covid patients in the ICU than the team had seen before, and they tended to be younger now. “Our median age has dropped to the mid-40s, and at the start of the pandemic, it was between 70 to 80,” Dombrouski went on. Then, her team got a call from Oklahoma, three wide western states away, asking if St. Patrick could take a transfer patient.
8th Nov 2021 - STAT News

Antibody levels not the only immunity marker: 5 takeaways from Covid-19 press conference on Nov 8

On Monday (Nov 8), the Singaporean multi-ministry task force tackling Covid-19 here held a press conference to announce further developments in Singapore's fight against the virus. 5 Takeaways from the eveny....
8th Nov 2021 - Straits Times

Sajid Javid says 'get Covid booster jabs to prevent restrictions over Christmas'

The Health Secretary has urged people to get booster jabs in order to prevent a return of restrictions over the approaching Christmas period. Sajid Javid thanked those who’ve already had their vaccines and said it is “not too late” for those who’ve yet to have a first and second jab to come forward. Sajid Javid has urged anyone who is eligible to come forward and receive their Covid booster and flu vaccines in the run up to Christmas. The Government is encouraging people to ‘top up’ their protection against Covid with winter approaching, as immunity from the vaccines starts to decrease after six months, especially for the elderly and vulnerable.
7th Nov 2021 - Yorkshire Post


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

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Novavax to complete data submission to FDA by end of the year for authorization of its coronavirus vaccine

The biotechnology company Novavax plans to submit complete data to the US Food and Drug Administration soon for possible emergency use authorization of its coronavirus vaccine, CEO Stanley Erck told CNN in a phone interview Friday.
6th Nov 2021 - CNN

Pfizer Says Covid-19 Pill Is 89% Effective in Preliminary Assessment

Pfizer Inc. said a preliminary look at study results found that its experimental pill was highly effective at preventing people at high risk of severe Covid-19 from needing hospitalization or dying, the latest encouraging performance for an early virus treatment. The company’s drug cut the risk of hospitalization or death in study subjects with mild to moderate Covid-19 by about 89% if they took the pill within three days of diagnosis, Pfizer said Friday. The drug, called Paxlovid, was also found to be generally safe and well-tolerated in the early look at ongoing study results, the company said.
6th Nov 2021 - The Wall Street Journal

Autopsies on More Covid Victims Needed to Understand Virus, Scientists Say

In an air-locked chamber in the world’s largest research hospital, Daniel Chertow and a half-dozen doctors and scientists clad in astronaut-inspired protective gear are carrying out a microscopic search inside a 26-year-old man. The patient went to the hospital with chest pain in spring 2020. He didn’t have typical Covid-19 symptoms, but Chertow wants to study him as part of a broader mission to understand where in the body the coronavirus goes and what it does in each of those places. If you’re a Covid case in Chertow’s emerging pathogens lab, you’re not there for treatment; you’re the subject of an autopsy.
6th Nov 2021 - Bloomberg

Pfizer Results Open Door to New Chapter for Covid Treatments

The world needs an easy-to-take Covid-19 treatment. Pfizer Inc.’s and Merck & Co. Inc.’s Covid pills may be just that. But questions remain about how well they will work in the real world, how safe they are and whether they will need to be taken in drug cocktails rather than alone. Pfizer’s Covid pill results were hailed as remarkable Friday, the drug reduced the risk of hospitalization or death by 89% in patients. It follows a successful Covid pill trial from rival Merck in October and both drugmakers are now working to get regulatory authorization. That’s left even the most skeptical doctors and scientists cheering the moment as a feat for drug development and a possible turning point in the pandemic.“Just stunning,” Ashish Jha, dean of the Brown University School of Public Health, said in a tweet about the results. He added that the “implications of effective therapeutics for ending the pandemic are very, very large.”
6th Nov 2021 - Bloomberg

Oral vaccines and novel tech: CEPI announces grants for 'variant-proof' COVID-19 vaccine development

CEPI, the Coalition for Epidemic Preparedness Innovations, has announced the first funding awards under a $200m program to advance development of vaccines against SARS-CoV-2 variants and other betacoronaviruses.
5th Nov 2021 - BioPharma-Reporter.com

U.S. cancels multimillion-dollar deal with coronavirus vaccine maker whose plant ruined Johnson & Johnson doses

The federal government has canceled a deal worth $628 million with Emergent BioSolutions, the Maryland-based vaccine manufacturer that was a vanguard of the Trump administration’s program to rapidly produce vaccines to counter the coronavirus pandemic. The company disclosed the development on Thursday in a conference call discussing its latest financial results. The cancellation comes after Emergent’s manufacturing facilities in Baltimore were found to have produced millions of contaminated vaccine doses this spring, prompting a months-long shutdown. Emergent will forgo about $180 million due to the contract’s termination, the company said. As part of its coronavirus efforts, the federal government had invested in building additional capacity at two of the firm’s sites.
5th Nov 2021 - The Washington Post

Is the debate over the origin of Covid-19 still worth having?

The ongoing rhetoric from Republican politicians about the origin of Covid-19 accomplishes nothing other than further polarizing U.S. society. The available public records show that the work done at the Wuhan Institute of Virology using U.S. government funds could not have created SARS-CoV-2, The most recent lab-leak related controversy has centered on grant-related paperwork violations. The scientific community has also been riven by unpleasant disputes. Allegations have been made that lab-leak opponents must have conflicts of interest, however nebulous. One positive outcome is that lab-leak theory has refocused the world’s virologists on an important scientific topic: gain-of-function research.
5th Nov 2021 - STAT News

COVID-19 vaccines more protective than 'natural' immunity

A previous infection with SARS-CoV-2 and COVID-19 vaccination can provide immunity and protection against future illness. A new study has compared the level of immunity afforded by a previous infection with the protection provided by a COVID-19 vaccine. The results suggest that COVID-19 mRNA vaccines are around five times more effective at preventing hospitalization than a previous infection.
5th Nov 2021 - Medical News Today

Novavax completes process for WHO emergency use approval of COVID-19 vaccine

Vaccine developer Novavax Inc said on Thursday it has completed the submission process for emergency use listing of its COVID-19 vaccine candidate with the World Health Organization. The company submitted to the health agency all modules required for the evaluation of NVX-CoV2373, its protein-based COVID-19 vaccine, days after receiving its first emergency use authorization from Indonesia. "The first authorization of the COVID-19 vaccine... will fill a vital need for Indonesia, which is the fourth most populous nation on earth and continues to work to procure sufficient vaccine for its population," Chief Executive Stanley Erck said during an investor call.
5th Nov 2021 - Reuters

White House says it is still committed to finding COVID's origin

The White House said on Thursday that understanding the origins of COVID-19 remains a key focus of Biden administration and that they will continue pushing for answers. "It's incredibly important for us to get to the bottom of this," said spokesperson Karine Jean-Pierre. "Time is of the essence" and the U.S. and its partners will continue to fight for transparency from China.
5th Nov 2021 - Reuters

Gene linked to doubling risk of COVID-19 death found by UK scientists

British scientists have identified a version of a gene that may be associated with double the risk of lung failure from COVID-19, a finding that provides new insights into why some people are more susceptible than othersto severe illness and which opens possibilities for targeted medicine. The high-risk genetic variant is in a chromosome region that is also tied to double the risk of death in COVID-19 patients under age 60. Around 60% of people with South Asian ancestry carry the high-risk version of the gene, researchers at Oxford University said on Friday, adding the discovery may partly explain the high number of deaths seen in some British communities, and the devastation wrought by COVID-19 in the Indian subcontinent.
5th Nov 2021 - Reuters


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

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UK Approves Merck Covid Drug Molnupiravir to Fill In Where Vaccines Can't

The U.K. was the first country to approve a Covid-19 vaccine; it has now become the first to approve an at-home treatment for Covid. On Thursday, the medicines regulator, MHRA, green-lit the antiviral drug molnupiravir, produced by Ridgeback Biotherapeutics and Merck & Co. and shown in trials to halve the risk of hospitalization or death in those with mild to moderate disease. Health Secretary Sajid Javid called it a “historic day for our country.” For once that might not be an overstatement. Beyond Britain, the new drug should be a reminder of the importance of antivirals in the fight against this and future pandemics. The molnupiravir approval couldn’t be timelier. Britain has had a stubbornly high Covid infection rate. Although the most recent wave has not led to a marked increase in deaths from the virus, hospitals face a gargantuan backlog of delayed procedures, Covid wards are fuller than is comfortable and there are worries that a bad flu season could tip an overstretched health service into deeper crisis.
4th Nov 2021 - Bloomberg

Oxford Scientists Find Gene That Doubles Risk of Dying From Covid-19

Scientists identified a specific gene that doubles the risk of respiratory failure from Covid-19 and may go some way to explaining why some ethnic groups are more susceptible to severe disease than others. Researchers from the University of Oxford found that a higher-risk version of the gene most likely prevents the cells lining airways and the lungs from responding to the virus properly. About 60% of people with South Asian ancestry carry this version of the gene, compared with 15% of people with European heritage, according to the study published Thursday. The findings help explain why higher rates of hospitalization and death may have been seen in certain communities and on the Indian subcontinent. The authors cautioned that the gene cannot be used as a sole explanation as many other factors, such as socioeconomic conditions, play a role. Despite a significant impact from the virus to people with Afro-Caribbean ancestry, only 2% carry the higher-risk genotype. People with the gene, known as LZTFL1, would particularly benefit from vaccination, which remains the best method of protection, the authors said. The findings raise the possibility of research into treatments specific to patients with this gene, though no tailored drugs are currently available.
4th Nov 2021 - Bloomberg

Britain approves Merck's oral COVID-19 pill in world first

Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19 antiviral oral pill jointly developed by Merck and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic.
4th Nov 2021 - Reuters

AstraZeneca pulls request for Swiss approval of COVID shot

AstraZeneca said Thursday that it is withdrawing its application for approval of its COVID-19 vaccine in Switzerland because the country's medical regulator wanted to restrict its use to people over age 50. Switzerland has cleared the BioNTech-Pfizer, Moderna and Johnson & Johnson vaccines for use. However, national medical regulator Swissmedic hadn't yet granted marketing authorization for the AstraZeneca vaccine.
4th Nov 2021 - ABC News

Indian home-grown Covid-19 shot wins WHO emergency use approval

The World Health Organization (WHO) said on Wednesday that it has granted approval for Indian drugmaker Bharat Biotech's home-grown Covid-19 vaccine for emergency use listing, paving the way for it to be accepted as a valid vaccine in many poor countries. The WHO tweeted that its technical advisory group had ruled that benefits of the shot, known as Covaxin, significantly outweighed the risks and that it met WHO standards for protection against Covid-19. The decision had been delayed as the advisory group sought additional clarifications from Bharat Biotech before conducting a final risk-benefit assessment for the vaccine's global use. WHO's Strategic Advisory Group of Experts on Immunization also recommended Covaxin's use in two doses, with an interval of four weeks, in age groups 18 and above. These recommendations are in line with the company's guidance.
4th Nov 2021 - CNN

COVID-19: 'Millions of years lost' and life expectancy cut short around the world

More than 28 million "extra years of life" have been lost during the coronavirus pandemic, a new study has found. By comparing the lives cut short by COVID-19 and the estimated normal life spans of those who died, researchers, led by a team at Oxford University, calculated that millions of years of life have been lost from premature deaths. The findings also follow a significant fall in life expectancy around the globe. The new research assessed the toll of the pandemic on 37 countries, including England and Wales.
4th Nov 2021 - Sky News

No decrease in effectiveness if COVID-19 jab and flu vaccine is taken together - WHO

People can get inoculated against COVID-19 and the seasonal influenza at the same time without compromising the vaccines' effectiveness, a World Health Organization official said on Thursday. "Anybody can get both the vaccines together - there is no decrease in effectiveness of either of the vaccines when given together at one point of time," Siddhartha Datta, the WHO Europe's regional adviser for vaccines, told a news briefing.
4th Nov 2021 - Reuters

EU regulator reviewing data on AstraZeneca COVID-19 booster shots

The European Union's drug regulator said on Thursday it was in discussions with AstraZeneca (AZN.L) over possible authorisation of booster doses of the drugmaker's COVID-19 vaccine, after it already gave the green light to mRNA booster shots. "AstraZeneca is submitting data to us. Actually today they submitted a new package of data that could support an extension to use the booster," the European Medicines Agency's head of vaccines strategy, Marco Cavaleri, said at a briefing. "We will be discussing with them whether this data could be sufficient for (authorisation) or whether we need more evidence," Cavaleri added.
4th Nov 2021 - Reuters

Factbox: Countries rush to buy Merck's experimental COVID-19 pill

While the drug's approval in the United States is still pending, Britain on Thursday became the first country in the world to approve the pill. Last week the company reached a deal with the United Nations-backed Medicines Patent Pool that will allow more companies to manufacture generic versions of the pill with a royalty-free licence applying to 105 low- and middle-income countries. So far Merck has agreed to license the drug to several India-based generic drugmakers.
4th Nov 2021 - Reuters

Europe faces real threat of COVID-19 resurgence, WHO Europe head says

European countries must work harder to prevent the coronavirus spreading further as deaths and new cases surge, the World Health Organization's Europe head said on Thursday. Current transmission rates in 53 European countries are of "grave concern" and new cases are nearing record levels, exacerbated by the more transmissible Delta variant of the virus, the WHO's Hans Kluge told a media briefing. "We must change our tactics, from reacting to surges of COVID-19, to preventing them from happening in the first place,"
4th Nov 2021 - Reuters

Britain approves Merck's COVID-19 pill in world first

Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19 antiviral pill jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic. Britain's Medicines and Healthcare products Regulatory Agency (MHRA) recommended the drug, molnupiravir, for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease. It will be administered as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, the regulator said, citing clinical data
4th Nov 2021 - Reuters

UK authorizes Merck antiviral pill, 1st shown to treat COVID

Britain granted conditional authorization on Thursday to the first pill shown to successfully treat COVID-19 so far. It also is the first country to OK the treatment from drugmaker Merck, although it wasn’t immediately clear how quickly the pill would be available. The pill was licensed for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug, known molnupiravir, twice a day for five days. An antiviral pill that reduces symptoms and speeds recovery could prove groundbreaking, easing caseloads on hospitals and helping to curb outbreaks in poorer countries with fragile health systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
4th Nov 2021 - The Associated Press

Are COVID-19 boosters the same as the original vaccines?

Are COVID-19 boosters the same as the original vaccines? Yes, COVID-19 boosters use the same recipe as the original shots, despite the emergence of the more contagious delta variant. The vaccines weren’t tweaked to better match delta because they’re still working well. The vaccines work by training your body to recognize and fight the spike protein that coats the coronavirus and helps it invade the body’s cells. Delta’s mutations fortunately weren’t different enough to escape detection. The increased protection you might get from a booster adjusted to better match the delta or other variants would be marginal, says Dr. Paul Goepfert, director of the Alabama Vaccine Research Clinic at the University of Alabama at Birmingham.
4th Nov 2021 - The Associated Press

Real-world study shows J&J COVID-19 vaccine 74% effective

The Johnson & Johnson (J&J) adenovirus-based COVID-19 vaccine is 74% effective in preventing SARS-CoV-2 infection even amid phases of high Alpha (B117) and Delta (B1617.2) variant circulation, according to the preliminary findings of a real-world US study yesterday in JAMA Network Open. The comparative-effectiveness study, led by researchers from nference, a Massachusetts software company affiliated with Janssen, maker of the J&J vaccine, involved mining the Mayo Clinic electronic health records (EHRs) of 8,889 vaccinated and 88,898 matched unvaccinated adults living in 1 of 15 states from Feb 27 to Jul 22, 2021. The EHRs were from the multistate Mayo Clinic Health System. Men made up roughly half of both groups of patients, with a mean age of 52.4 years in the vaccinated group and 51.7 in the unvaccinated group.
4th Nov 2021 - CIDRAP

Shipping delays, supply chain expansions ding Moderna's COVID-19 vaccine business

Moderna has been biotech’s biggest growth story in 2021, but the company’s rate of expansion slowed considerably in recent months as shipping delays and a supply chain scale-up took a toll. In the third quarter, the mRNA biotech delivered 208 million COVID-19 vaccine doses worldwide, a figure Chief Financial Officer David Meline called a “relatively modest” increase from the 199 million doses it delivered in the second quarter. What’s behind the slowdown? Moderna shipped more doses internationally in the third quarter than in prior periods. Those shipments required “longer delivery lead times” than its earlier doses, the company said, leading to export delays. “Our supply chain became more complex, with increased deliveries” to various countries around the world, CEO Stéphane Bancel said on a conference call Thursday. Moderna has been charging lower prices to many of the recently added countries, Bancel added.
4th Nov 2021 - FiercePharma

Merck and Ridgeback's COVID-19 oral antiviral molnupiravir joins the pandemic response with U.K. nod

Since the start of the pandemic, even as vaccines and monoclonal antibodies made their way onto the market, an authorized oral antiviral therapy evaded the global response. Not anymore. Merck & Co. and Ridgeback Therapeutics' molnupiravir has scored its first authorization in the world. U.K. Regulators signed off on the oral antiviral for adults who've had a positive COVID-19 test and who have at least one risk factor. The country's Medicines and Healthcare products Regulatory Agency green-lit the drug based on an interim analysis from the phase 3 Move-Out trial. The study showed the med, given at 800 mg twice daily, reduced the risk of hospitalization or death by about 50% in adult patients who were not hospitalized or vaccinated. For the study, the mild-to-moderate patients had symptom onset within five days of randomization, and they also had at least one risk factor. Ahead of the authorization, the U.K. government inked a deal to purchase 480,000 courses from Merck. In the U.K., the drug will be marketed as Lagevrio.
4th Nov 2021 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 4th Nov 2021

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Court Rules Against Religious Exemption for New York Healthcare Workers’ Vaccine Mandate

A federal appellate court sided with New York officials Friday and removed a temporary injunction that had allowed healthcare workers to seek religious exemptions to the state’s Covid-19 vaccination mandate. Three judges of the U.S. Court of Appeals for the Second Circuit ruled against plaintiffs in two cases brought by healthcare workers who said New York’s mandate violated their Christian beliefs. The state required all workers in hospitals and nursing homes to receive at least one dose of Covid-19 vaccine by Sept. 27 or face termination. Similar cases have been brought challenging vaccination mandates in other states, and legal experts have said the questions they raise could end up before the U.S. Supreme Court.
3rd Nov 2021 - The Wall Street Journal

Analysis: Wide array of opponents prepare to fight Biden vaccine mandate

The country's first national COVID-19 vaccine mandate, expected to be unveiled by the Biden administration this week, is likely to unleash a frenzied legal battle that will hinge on a rarely used law and questions over federal power and authority over healthcare. States, companies, trade groups, civil liberty advocates and religious organizations are expected to rush to court with demands to stop the mandate in its tracks. Two dozen Republican state attorneys general have already vowed to use "every legal option" to fight the mandate and 40 Republican lawmakers said on Wednesday they were preparing their own challenge.
3rd Nov 2021 - Reuters

Antibodies in breast milk provide extra benefit to babies; vaccine protection varies among immunocompromised

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review. Mothers' COVID-19 antibodies provide unexpected benefit. COVID-19 antibodies passed from infected mothers to their breastfeeding newborns provide more benefit to the baby than researchers expected to see, according to a report published on Wednesday in JAMA Network Open.
3rd Nov 2021 - Reuters

U.S. rolls out COVID-19 vaccine for young children, ending long wait for some parents

Seven-year-old Gael Coreas stuck out his left arm fearlessly to receive his first COVID-19 shot at a health clinic in the nation's capital on Wednesday, wincing briefly as cameras flashed to capture the moment. Coreas was in the first cohort of young children to be inoculated as the United States on Wednesday began administering the COVID-19 vaccine to children ages 5 to 11, the latest group to become eligible for the shots that provide protection against the illness to recipients and those around them.
3rd Nov 2021 - Reuters

Saudi approves Pfizer's COVID-19 vaccine for age group 5-11

The Saudi Food and Drug Authority said on Wednesday it had given its approval to use Pfizer's COVID-19 vaccine for those between five and eleven years of age. The authority added in a statement its decision was "based on data provided by the company, which showed the vaccine met the special regulatory requirements".
3rd Nov 2021 - Reuters

JCVI failed to back youth Covid jabs despite favourable modelling

The government’s independent vaccine advisers recommended against Covid shots for healthy teenagers despite considering evidence that the jabs would reduce infections, hospitalisations and some deaths in the age group. Modelling reviewed by the Joint Committee on Vaccination and Immunisation (JCVI) in June showed that fully vaccinating 80% of 12- to 17-year-olds would lead to “large reductions” in infections and a “substantial reduction” in hospitalisations in the age group. The modelling from the University of Warwick was considered alongside calculations from Public Health England that found vaccinating healthy young people in an overlapping age group – those aged 15 to 19 – could reduce intensive care admissions and prevent two deaths per million in the teenagers receiving the shots.
3rd Nov 2021 - The Guardian

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports. In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.
3rd Nov 2021 - The BMJ

Research confirms impact of Covid-19 on doctors’ mental health

The Covid-19 crisis triggered high levels of anxiety and depression among doctors in the UK, Italy and Spain, a new study has found. The research of 5,000 survey responses, across the three countries, found Italian doctors were most likely to have suffered during the crisis last year. The study, published in the peer-reviewed journal PLOS ONE, measured the mental wellbeing of doctors in Catalonia (Spain), Italy and the UK during June, November and December 2020.
3rd Nov 2021 - The Independent

Covid-19 virus does not infect human brain cells, new study suggests

The virus that causes Covid-19 does not infect human brain cells, according to a study published in the journal Cell. The findings will raise hopes that the damage caused by Sars-CoV-2 might be more superficial and reversible than previously feared. The study contradicts earlier research that suggested the virus infects neurons in the membrane that lines the upper recesses of the nose. This membrane, called the olfactory mucosa, is where the virus first lands when it is inhaled. Within it are olfactory sensory neurons (OSNs), which are responsible for initiating smell sensations. They are tightly entwined with a kind of support cell called sustentacular cells.
3rd Nov 2021 - The Guardian

Sputnik Light produces strong level of antibodies against COVID-19 - early-stage trial

Russia's one-dose Sputnik Light vaccine had a good safety profile and induced strong immune responses especially in people who had already encountered COVID-19, according to the results of phase I and II trials published in The Lancet medical journal. The vaccine, a single-dose version of the two-dose Sputnik V vaccine unveiled last year, has already entered later phases of studies and is widely used in Russia, but the publication of the early research in a top Western journal is a milestone as Russia moves towards making Sputnik Light its main vaccine for export.
3rd Nov 2021 - Reuters

Lilly pulls COVID-19 treatment from EU review while U.S. stocks up

Eli Lilly has retracted a request for European Union approval of its antibody-based treatment for COVID-19, citing a lack of demand from EU member states as the bloc focuses on other suppliers. The European Medicines Agency (EMA) said on Tuesday it had ended its rolling review of a cocktail of two monoclonal antibodies known as etesevimab and bamlanivimab after the U.S.-based drugmaker withdrew from the process.
3rd Nov 2021 - Reuters

Indian home-grown COVID-19 shot wins WHO emergency use approval

The World Health Organization (WHO) said on Wednesday that it has granted approval for Indian drugmaker Bharat Biotech's home-grown COVID-19 vaccine for emergency use listing, paving the way for it to be accepted as a valid vaccine in many poor countries. The WHO tweeted that its technical advisory group had ruled that benefits of the shot, known as Covaxin, significantly outweighed the risks and that it met WHO standards for protection against COVID-19.
3rd Nov 2021 - Reuters India

Factbox: Countries rush to buy Merck experimental COVID-19 pill

Merck has signed eight deals to sell more than a total of 2 million courses of its experimental COVID-19 pill molnupiravir to governments around the world as countries scramble to tame the virus. It has applied for approval in the United States and said it can make 10 million courses in 2021. Last week the company reached a deal with the United Nations-backed Medicines Patent Pool that will allow more companies to manufacture generic versions of the pill with a royalty-free license applying to 105 low- and middle-income countries. So far Merck has agreed to license the drug to several India-based generic drugmakers.
3rd Nov 2021 - Reuters

Analysis: Country by country, scientists eye beginning of an end to the COVID-19 pandemic

As the devastating Delta variant surge eases in many regions of the world, scientists are charting when, and where, COVID-19 will transition to an endemic disease in 2022 and beyond, according to Reuters interviews with over a dozen leading disease experts. They expect that the first countries to emerge from the pandemic will have had some combination of high rates of vaccination and natural immunity among people who were infected with the coronavirus, such as the United States, the UK, Portugal and India. But they warn that SARS-CoV-2 remains an unpredictable virus that is mutating as it spreads through unvaccinated populations.
3rd Nov 2021 - Reuters

College football didn't fuel COVID-19 spread among players, study suggests

COVID-19 didn't appear to spread efficiently within and among teams competing in the fall 2020 Southeastern Conference (SEC) college football season, finds an observational study published late last week in JAMA Network Open. The study, led by a Texas A&M University researcher, analyzed close contacts (within 6 feet) among opposing players during official games and COVID-19 athlete testing data from Sep 26 to Dec 19, 2020. At that time, cases were surging, but the more transmissible Delta (B1617.2) SARS-CoV-2 variant had not yet been identified in the United States. This may limit the findings' generalizability to pandemic phases since the emergence of Delta.
3rd Nov 2021 - CIDRAP

Molnupiravir: another Covid-19 treatment, another opportunity to recognize inequity

The Covid-19 pandemic has disproportionately affected communities of color and those with lower socioeconomic means, two groups that overlap to a significant extent in the U.S. Merck’s submission of molnupiravir, its oral antiviral drug, to the Food and Drug Administration for emergency use authorization will only heighten inequities wrought by the pandemic. Merck and others have touted this drug as a game-changer. Although the data from randomized controlled trials have not been made available for review, the press release claims that a five day course of molnupiravir is associated with a 6.8% absolute reduction in hospitalization or death in patients with moderate Covid-19 not requiring hospitalization when the drug is taken within five days of the onset of symptoms.
3rd Nov 2021 - STAT News


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Pfizer Covid Vaccine for Kids Ages 5-11 Gets CDC Advisers' Backing

Younger children across the U.S. are now eligible to receive Pfizer Inc.’s Covid-19 vaccine, after the head of the Centers for Disease Control and Prevention granted the final clearance needed for shots to begin. CDC Director Rochelle Walensky recommended the vaccine for children from 5 to 11 years old. The decision ushers in a new phase in the U.S. pandemic response, widening access to vaccines to some 28 million more people at the same time that Americans who received shots earlier in the pandemic are lining up for booster doses.
2nd Nov 2021 - Bloomberg

Pfizer/BioNTech booster vaccine reduces COVID-19 hospitalisations

International researchers have identified that the Pfizer/BioNTech booster vaccine is highly effective at reducing COVID-19 hospitalisations. Experts from the Clalit Research Institute and Harvard University have collaborated to investigate the efficacy of the Pfizer/BioNTech BNT162B2 booster vaccine against the Delta variant of SARS-CoV-2, discovering that it lowers hospitalisations from the disease. The study, based in Israel, utilised one of the world’s largest integrated health record databases, illuminating the effectiveness of a third “booster” dose of the BNT162B2 vaccine in a nationwide mass-vaccination setting. The investigation was partly funded by the recently announced Ivan and Francesca Berkowitz Family Living Laboratory.
2nd Nov 2021 - Health Europa

CDC advisers discuss Covid-19 vaccines for kids

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is meeting to discuss Pfizer's Covid-19 vaccine for children ages 5 to 11. Follow here for the latest news updates.
2nd Nov 2021 - CNN

Indonesia is first country to authorize Novavax Covid-19 vaccine

Biotechnology company Novavax said Monday that Indonesia has given the world's first emergency use authorization for its Covid-19 vaccine, which uses a different technology than currently used shots. The vaccine doesn't require the extremely cold storage temperatures that some other vaccines need, which could allow it to play an important role in increasing supplies in poorer countries around the world.
2nd Nov 2021 - NBC News

Singapore may see 2,000 Covid-19 deaths each year, minister says

Singapore could see as many 2,000 Covid-19 deaths annually over time, a minister said on Monday as the country battles its biggest surge in infections. At 0.2% Singapore's Covid-19 case fatality rate is similar to the rate of deaths from pneumonia before the pandemic struck, said Janil Puthucheary, a senior minister of state in parliament. It is also lower than other countries where cases surged before vaccination, he said. "But it does mean that over time, the absolute number of deaths from Covid-19 will rise despite the best possible medical care," he said. "We could have perhaps 2,000 deaths per year from Covid-19."
2nd Nov 2021 - CNN

AstraZeneca increases COVID-19 vaccine supply to Thailand after row

AstraZeneca Plc provided Thailand 10.5 million doses of its COVID-19 vaccine last month, the firm said on Tuesday, months after an official said the government was considering curbing exports from its local plant because of lower supplies. Thailand had been pushing for 10 million doses each month to be able to fight back against coronavirus infections in the country of about 66 million people. James Teague, managing director of AstraZeneca Thailand, said that the company had increased batchwise vaccine production by a fifth at its plant, from 580,000 doses to on average 700,000.
2nd Nov 2021 - Reuters

Austrian army dogs join growing global pack of COVID-sniffers

Austria's army has successfully trained two dogs to sniff out COVID-19, it said on Tuesday, adding to a mass of evidence that dogs can be deployed to identify carriers of the virus. Trials across the world from Thailand to Britain have found dogs can use their powerful sense of smell to detect the coronavirus with a high degree of accuracy, suggesting they could be regularly deployed as an additional line of safety at large events and border entry points. Airports in Finland and Chile began deploying dogs to screen arrivals for COVID-19 last year.
2nd Nov 2021 - Reuters

U.S. buys more doses of Lilly's COVID-19 treatment for $1.29 bln

Eli Lilly and Co said on Tuesday that the U.S. government bought 614,000 additional doses of its COVID-19 antibody therapy for $1.29 billion. The U.S. Food and Drug Administration in September revised its emergency use authorization for the company's cocktail, bamlanivimab and etesevimab, to include for use in patients who have been exposed to the virus and are at high risk for progression to severe disease. Under the deal, Lilly will supply a minimum of 400,000 doses of its treatment by Dec. 31 and the rest by Jan. 31. The new purchase is estimated to add $840 million to the company's 2021 revenue forecast and about 25 cents of additional earnings per share, Lilly said.
2nd Nov 2021 - Reuters

Two UK COVID test makers pull devices due to new review

Two producers of COVID-19 tests in Britain said on Tuesday they had pulled some of their tests from the market after a new review system came into force, which has not yet granted approval for their previously accepted products. Avacta said under the new system suppliers of COVID-19 tests had to submit information regarding their products for desktop review if they wished to remain on sale in Britain. It said it had submitted its information ahead of the Sept. 1 deadline and was still waiting for a response.
2nd Nov 2021 - Reuters

CDC panel debates: Should all school kids get COVID vaccine?

Should all school-age kids get Pfizer’s pediatric COVID-19 vaccine? That’s the question before an influential government advisory panel Tuesday. The Food and Drug Administration has authorized emergency use of kid-size doses for children ages 5 to 11. But the Centers for Disease Control and Prevention also must sign off before widespread vaccinations begin in that age group. CDC’s advisers are weighing who will get the most benefit as they deliberate whether to recommend the shots for up to 28 million more children, or perhaps only for those most vulnerable to serious illness. Their recommendation goes to the CDC’s director, Dr. Rochelle Walensky, for the final say. “Today is a monumental day in the course of this pandemic,” Walensky told the advisory panel Tuesday.
2nd Nov 2021 - The Associated Press

COVID: Medical experts step up after dismissing menstrual changes

After her first Pfizer vaccine five months ago, Dahye Yim, 30, noticed something different with her menstrual cycle.Unusually heavier and with more physical symptoms such as a migraine, she went online to see if other women had experienced post-vaccine cyclical changes. She uncovered similar stories but failed to find scientifically-backed information on possible short-term vaccine side effects. The South Korean national, a PhD student based between London and Berlin, told Al Jazeera: “After I received my second dose in September, I noticed a lump under my armpit and I was able to find out very easily that this was a side effect that was nothing to worry about. This helped me calm down.
2nd Nov 2021 - Scientific American


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COVID vaccine for younger kids already being packed, shipped

Anticipating a green light from vaccine advisers, the Biden administration is assembling and shipping millions of COVID-19 shots for children ages 5-11, the White House said Monday. The first could go into kids’ arms by midweek. “We are not waiting on the operations and logistics,” said coronavirus coordinator Jeff Zients. By vaccinating children, the U.S. hopes to head off another coronavirus wave during the cold-weather months when people spend more time indoors and respiratory illnesses can spread more easily. Cases have been declining for weeks, but the virus has repeatedly shown its ability to stage a comeback and more easily transmissible mutations are a persistent threat.
1st Nov 2021 - The Associated Press

New Delta coronavirus subvariant AY.4.2: What we know so far

Health officials and scientists are closely tracking a new mutation of the coronavirus amid concerns that it could be more transmissible than the original strain. A subvariant of the Delta variant of the virus labelled AY.
1st Nov 2021 - Al Jazeera English on MSN.com

Moderna Confirms FDA Delayed Covid-19 Vaccine in Adolescents to Review Myocarditis Risk

The Food and Drug Administration is delaying a decision on Moderna Inc.’s MRNA application to authorize use of its Covid-19 vaccine in adolescents to assess whether the shot leads to a heightened risk of myocarditis, the company said. The FDA notified Moderna on Friday evening that an analysis may not be completed until January of next year while the agency reviews recent international data on the risk of myocarditis after vaccination, the company said Sunday. The Wall Street Journal reported earlier this month that the FDA was delaying a decision on Moderna’s application for authorization in 12- to 17-year-olds after several Nordic countries limited use due to myocarditis reports.
1st Nov 2021 - The Wall Street Journal

Novavax Covid-19 Vaccine Gets First Authorization, in Indonesia

Indonesia became the first country to authorize the use of a Covid-19 vaccine developed by Novavax Inc. and manufactured by the Serum Institute of India.Novavax said Monday that Indonesia’s drug regulator cleared use of the new vaccine, called Covovax, in adults 18 years and older. The decision shows that, despite receiving substantial financial support from the U.S. government, the Novavax vaccine will be used in other countries first. Novavax said it expected additional countries to authorize the vaccine in coming weeks and months.
1st Nov 2021 - The Wall Street Journal

Novavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says

Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within "weeks," its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia. Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.
1st Nov 2021 - Reuters

Americans who received the one-dose Johnson & Johnson COVID-19 vaccine were 3.5 times as likely to develop rare blood clots compared to the general population, study finds

Recipients of the J&J COVID-19 vaccine are 3.5 times as likely to develop a rare, deadly, blood clotting condition than the general population, a new study finds. Researchers found that 8.5 J&J recipients developed the clots for every 100,000 person years, compared to only 2.5 out of the general population. Researchers found that women between aged 30 and 64 were most at risk of developing the clotting. Authorization of the vaccine was paused for ten days during April due to concerns of the blood clotting developing in women. Cerebral venous sinus thrombosis, or CVST, is a dangerous condition that can cause a person to suffer stroke, or even die
1st Nov 2021 - Daily Mail

COVID-19 News: Indonesia Grants Emergency Use To Novavax Vaccine

Indonesia granted emergency use authorization to Novavax Inc.'s COVID-19 vaccine on Monday, paving the way for other countries to allow the vaccine for emergency use as well.
1st Nov 2021 - International Business Times

Infertility is not a risk with Covid-19 vaccines for kids

It's among parents' top worries around kids getting vaccinated against Covid-19: Could the vaccine somehow impair their child's future fertility? A survey released by the Kaiser Family Foundation last week found that 66% of parents of 5- to 11-year-olds worried that vaccines might negatively impact children's fertility later on. Doctors and public health officials are united in assuring parents this is not a concern. "Unfounded claims linking COVID-19 vaccines to infertility have been scientifically disproven," the American Academy of Pediatrics -- which represents doctors who specialize in treating children -- says in a statement on its website.
1st Nov 2021 - CNN

Risk of Covid-19 death '32 times greater' if unvaccinated than if double-jabbed

The risk of death involving Covid-19 is 32 times greater in unvaccinated people than in people who have received both doses, new research suggests. Mortality rates for coronavirus deaths were found to be “consistently lower” for those who had had both jabs compared with those who had had one or no vaccinations, according to the Office for National Statistics (ONS). The research used age-standardised mortality rates, which take into account differences in age structure and population size, to allow comparisons between vaccination groups.
1st Nov 2021 - Belfast Telegraph

Breast milk shown to protect newborn babies against Covid-19

Newborn babies could have extra protection against Covid-19 by drinking their mother's breast milk, a new study has shown. Researchers at Swansea University and the University of Aberdeen found the ACE2 protein, which is commonly found in breast milk, acts as a "decoy" for the virus, trapping it in biological fluids and preventing it from infecting cells. The study may go some way to understanding why newborn babies are relatively protected against coronavirus and its harms when compared to older age groups.
1st Nov 2021 - Wales Online


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Moderna Told FDA Needs More Time to Assess Vaccine for Teenagers

Moderna Inc. said it was notified that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company’s Emergency Use Authorization request for its Covid vaccine kids aged 12 to 17 years old.
31st Oct 2021 - Bloomberg

Takeda eyeing early 2022 rollout of Novavax's COVID-19 shot in Japan - CEO

Takeda Pharmaceutical Co, the Japanese partner for Novavax Inc's COVID-19 vaccine, is preparing to seek regulatory approval for a roll out in Japan early next year, its top executive said on Friday. Novavax delayed filing for U.S. approval to the end of this year, and Politico reported this month that the Maryland-based company has faced production and quality problems. The drugmaker filed for conditional authorisation to British regulators on Wednesday and with Australia's Therapeutic Goods Administration on Friday
30th Oct 2021 - Reuters

Seniors 70 and older, front-line health workers, people who got 2 AZ doses can be offered boosters, NACI says

Canada's National Advisory Committee on Immunization (NACI) is recommending COVID-19 booster shots for all adults 80 years of age and older, and is also opening the door for certain other groups who may be at increased risk of lowered protection over time since their initial vaccinations. "Populations at highest risk of waning protection following their primary series and at highest risk of severe COVID-19 illness should be offered a booster dose of an mRNA COVID-19 vaccine at least six months after completing their primary series," NACI's new guidance released Friday said, noting that seniors 80 years and older "should" be offered a booster shot.
30th Oct 2021 - CBC.ca

Booster shot now advised for Canadians who received two shots of AstraZeneca vaccine

The National Advisory Committee on Immunization has expanded eligibility guidelines for booster shots of COVID-19 vaccines. Canada’s expert panel on COVID-19 vaccines is recommending boosters for people who received two doses of AstraZeneca or one dose of the Janssen vaccine, regardless of age, and frontline health workers who were vaccinated with mRNA shots that were spaced less than 28 days apart.
30th Oct 2021 - National Post

Covaxin approvals delay: Be transparent

Prime Minister Narendra Modi highlighted India’s contribution to the fight against coronavirus disease (Covid-19) during his intervention at the first G20 session on Saturday, foreign secretary Harsh Vardhan Shringla said. The top diplomat told a press briefing that PM Modi mentioned India’s medical supplies to over 150 countries as he spoke about the country’s vision of ‘One Earth, One Health’ for a collaborative approach in combating the pandemic. Speaking at the Group of 20 Leaders’ Summit in Rome, the prime minister conveyed that India is ready to produce 5 billion Covid-19 vaccine doses by 2022 end which will be available for the world. PM Modi invited G20 countries to make India their partner in economic recovery and supply chain diversification. “He also brought out the fact that despite challenges of the pandemic, India continued to be a trusted partner in the context of reliable supply chains,” Shringla told the special briefing in Rome.
30th Oct 2021 - Hindustan Times

Needle-free vaccine patches coming soon, say researchers and makers

Effective vaccines, without a needle: Since the start of the Covid-19 pandemic, researchers have doubled down on efforts to create patches that deliver life-saving drugs painlessly to the skin, a development that could revolutionise medicine. The technique could help save children's tears at doctors' offices, and help people who have a phobia of syringes. Beyond that, skin patches could assist with distribution efforts, because they don't have cold-chain requirements - and might even heighten vaccine efficacy. A new mouse study in the area, published in the journal Science Advances, showed promising results. The Australian-US team used patches measuring one square centimetre that were dotted with more than 5,000 microscopic spikes, "so tiny you can't actually see them," David Muller, a virologist at the University of Queensland and co-author of the paper, told AFP.
30th Oct 2021 - The Straits Times

COVID-19: US intelligence agencies admit the true origins of coronavirus may never be known

US spy agencies have admitted that the true origins of COVID-19 may never be known. The Office of the US Director of National Intelligence (ODNI) said on Friday that theories involving transmission from animals or a leak from a lab were plausible. However, the office added that analysts could not agree which was more likely or if any firm conclusion could be made at all. They did, however, dismiss suggestions that the virus originated as a bioweapon, saying backers of this theory "do not have direct access to the Wuhan Institute of Virology".
30th Oct 2021 - Sky News

Study of Hospitalized Covid-19 Patients Shows Vaccination Is Better Guard Than Prior Infection

Covid-19 was over five times more common among hospitalized people who were unvaccinated and had a previous infection, compared with those who were fully vaccinated and hadn’t had Covid-19 before, a study published by the Centers for Disease Control and Prevention found. The report, released Friday and written by scientists from the federal agency as well as hospitals across the U.S., adds to the body of research suggesting that vaccines provide stronger protection against the coronavirus than prior-infection immunity. Research into immunity to Covid-19 has been limited in part by the short window of time in which the virus has been circulating and vaccines have been in use. Few clinical studies of patients who have recovered from Covid-19 have been conducted, compared with the more robust body of clinical research into the vaccines, making it hard to reach definitive conclusions about the nature of immunity provided by prior infection.
29th Oct 2021 - The Wall Street Journal

Pfizer-BioNTech Covid-19 Vaccine Authorized for Young Children by FDA

The Covid-19 vaccine from Pfizer Inc. PFE 1.30% and BioNTech SE BNTX -1.85% was authorized for use in children as young as 5 years old, the first shot that federal health regulators have permitted for them in the U.S. The decision by the Food and Drug Administration on Friday for children age 5 to 11 paves the way for one of the last remaining groups in the U.S. to get vaccinated against Covid-19, probably starting within days. The shot works safely, the FDA said. Once the Centers for Disease Control and Prevention gives its signoff, expected within days, the young children can begin getting their first dose. The children will be given two shots three weeks apart, the same schedule as adults and adolescents, although each shot will contain one-third of the dosage.
29th Oct 2021 - The Wall Street Journal

Canada says decision on allowing Pfizer's COVID-19 vaccine for children still weeks away

A Canadian decision on whether to approve Pfizer Inc’s COVID-19 vaccine for those aged 5 to 11 will not come before mid- to end-November, a senior official said on Friday. “I think we’re still at least a few weeks away from a final decision ... we’ve received some additional information just this past week that we’rem looking through,” Supriya Sharma, the federal health ministry’s chief medical adviser, told a briefing.
29th Oct 2021 - Reuters

Moderna to supply 56.5 mln more doses of its COVID-19 shot to vaccine alliance GAVI

Moderna Inc announced a pact with the GAVI vaccine alliance to supply a further 56.5 million doses of its COVID-19 vaccine in the second quarter of next year to low- and middle-income countries. The vaccine maker said the doses will be in addition to an earlier commitment to supply 60 million doses in the second quarter of 2022 to GAVI, which co-leads the COVAX facility for equitable distribution of COVID-19 shots around the world. The COVAX facility, backed by the World Health Organization and GAVI, has delivered some 400 million COVID-19 vaccine doses to more than 140 low- and middle-income countries, but several countries run the risk of failing to meet WHO's target of 40% vaccination coverage by year-end
29th Oct 2021 - Reuters

Malaysia to buy Pfizer Covid-19 vaccine for children aged 5 to 11

Malaysia said on Friday (Oct 29) it would proceed with the procurement of the Pfizer and BioNTech Covid-19 vaccine for children, following a United States expert panel's recommendation for the shot to be authorised for those aged five to 11. A panel of advisers to the US Food and Drug Administration voted on Tuesday to recommend the authorisation, saying the benefits of the vaccine outweigh the risks. The agency's decision is still pending. Malaysia's Health Minister Khairy Jamaluddin said on Twitter that other options, such as the vaccine made by China's Sinovac BioTech, would also be considered to ensure schools can reopen safely. About 62 per cent of teenagers aged between 12 and 17 in the South-east Asian country are fully vaccinated, government statistics showed on Friday.
29th Oct 2021 - The Straits Times

Egypt receives 3rd batch of J&J COVID-19 vaccine on Monday

The Cairo International Airport will receive a third batch of Johnson & Johnson (J&J) COVID-19 vaccine on Monday, said the Egyptian Ministry of Health on Saturday. The third batch of 1,058,000 doses is part of the ministry’s plan to offer varieties of anti-Coronavirus vaccines, especially for travelers, the ministry added. The shipment will be distributed to vaccination centers allocated for travelers. The shipment arrived in Egypt as part of the initiative reached between the African Vaccine Acquisition Trust (AVAT) and UNICEF for the African Union countries. On September 4, 2021, Egypt received the second batch of 525,600 J&J doses, while the first patch of Johnson & Johnson Vaccine against coronavirus was given to Egypt on August 9, 2021. The first batch included 21,600 doses.
23rd Oct 2021 - Egypt Today


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Israel Needs More Jabs, Tourist Safeguards to Avoid Fifth Covid Wave

Israel must do more to break down vaccine resistance and implement tougher safeguards as foreign tourists start returning next month, or risk a fifth Covid-19 wave, public health experts are warning. The increasingly urgent calls will be closely monitored worldwide as Israel has often been ahead of the curve in handling the coronavirus, from sweeping restrictions and vaccine programs to renewed outbreaks as its economy reopened. It’s in the vanguard again with the world’s first widespread booster program, which dramatically brought down a surge in cases generated by the delta variant, but it’s being warned of another critical juncture ahead.
28th Oct 2021 - Bloomberg

Delta Variant Is Spread by Vaccinated and Unvaccinated People Alike, Study Shows

People inoculated against Covid-19 are just as likely to spread the delta variant of the virus to contacts in their household as those who haven’t had shots, according to new research. In a yearlong study of 621 people in the U.K. with mild Covid-19, scientists found that their peak viral load was similar regardless of vaccination status, according to a paper published Thursday in The Lancet Infectious Diseases medical journal. The analysis also found that 25% of vaccinated household contacts still contracted the disease from an index case, while 38% of those who hadn’t had shots became infected.
28th Oct 2021 - Bloomberg

UK study finds vaccinated people easily transmit Delta variant in households

The Delta coronavirus variant can transmit easily from vaccinated people to their household contacts, a British study found on Thursday, although contacts were less likely to get infected if they were vaccinated themselves. The Imperial College London study illustrates how the highly transmissible Delta variant can spread even in a vaccinated population. The researchers underlined that did not weaken the argument for vaccination as the best way of reducing serious illness from COVID-19 and said booster shots were required.
28th Oct 2021 - Reuters

WHO says seeks more data from Merck on COVID anti-viral, from Bharat on vaccine

The World Health Organization (WHO) said on Thursday that it was seeking further data from Merck on its experimental new antiviral COVID-19 pill and hoped to issue guidance in coming weeks regarding its use for mild and moderate cases. "This is a drug that we are currently evaluating and we met with Merck on Friday to discuss data from their current clinical trials that are under way in other countries," WHO expert Maria van Kerkhove told a news conference where she was asked about Merck's molnupiravir, developed with Ridgeback Biotherapeutics.
28th Oct 2021 - Reuters

Covid-19: global vaccine production is a mess and shortages are down to more than just hoarding

In March 2021 drug manufacturers predicted that 12 billion doses of covid-19 vaccine, enough to fully immunise at least 70% of the world’s population, could be manufactured by the end of the year.1 That assessment was confirmed in September in a report by the International Federation of Pharmaceutical Manufacturers and Associations,2 though it also warned that “most doses in the production queue are already allocated” to high income countries. At the time of writing, only 1.3% of people in low income countries have received their jabs. Seventy countries have yet to vaccinate 10% of their populations, and 30 countries—including much of Africa—have vaccinated fewer than 2%.3 In Latin America, only one in four of the population has received a dose of covid vaccine.
28th Oct 2021 - The BMJ

Sixty million vaccine doses to be made on Teesside if regulator gives approval

Sixty million doses of the Novavax coronavirus vaccine will be produced on Teesside if approval is given by the UK's medicine regulator. The manufacturer has submitted final data on the vaccine to the Medicine and Healthcare products Regulatory Authority (MHRA) - and anticipates a "positive decision". If successful, it would mean all 60 million doses of the vaccine Britain has ordered would be produced by Fujifilm in Billingham. Stanley Erck, Novavax president, said: "This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based Covid-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus." According to the results of a phase three trial, announced in March, the jab offers 100% protection against severe disease, including all hospital admission and death.
28th Oct 2021 - ITV News

90 per cent of people in Delhi have antibodies against Covid-19, says sero survey

More than 90 per cent of people in India’s capital city have developed antibodies against the coronavirus, according to a latest serological survey. A Delhi government official told the media: “We have found Covid antibodies in more than 90 per cent of the samples collected during the sixth round of the survey.” However, the official cautioned that “we cannot say Delhi has achieved herd immunity despite such a high level of seroprevalence.” Experts say this high level of seroprevalence indicates that Delhi might not suffer any devastating Covid waves anytime soon. But it all depends on whether any other variant of the virus emerges in the city, they cautioned.
28th Oct 2021 - The Independent

Cheap antidepressant shows promise treating early COVID-19

The pill, called fluvoxamine, would cost $4 for a course of COVID-19 treatment. By comparison, antibody IV treatments cost about $2,000 and Merck s experimental antiviral pill for COVID-19 is about $700 per course. Some experts predict various treatments eventually will be used in combination to fight the coronavirus. Researchers tested the antidepressant in nearly 1,500 Brazilians recently infected with coronavirus who were at risk of severe illness because of other health problems, such as diabetes. About half took the antidepressant at home for 10 days, the rest got dummy pills. They were tracked for four weeks to see who landed in the hospital or spent extended time in an emergency room when hospitals were full.
28th Oct 2021 - The Independent

India's Optimus Pharma seeks approval to produce generic Merck COVID-19 pill

Indian bulk drugs manufacturer Optimus Pharma is seeking domestic regulatory approval to produce a generic version of Merck & Co's oral COVID-19 treatment molnupiravir, the company's top executive told Reuters on Thursday. If granted emergency use approval, the company could scale up production to 80 million capsules a month and is targeting a price of 40 cents per capsule, said D. Srinivasa Reddy, managing director at the Hyderabad-based company.
28th Oct 2021 - Reuters

EU set to produce over 3.5 billion COVID vaccine doses in 2022 - chief executive

The European Union will produce more than 3.5 billion doses of COVID-19 vaccines next year, the head of the bloc's excutive, European Commission President Ursula von der Leyen, said on Thursday. She added that the majority of these vaccines will be shipped abroad.
28th Oct 2021 - Reuters

U.S. CDC panel to discuss COVID-19 shots for younger kids on Nov. 2

An advisory panel of the U.S. Centers for Disease Control and Prevention will meet on Nov. 2 to discuss the use of COVID-19 vaccines in children aged between 5 and 11 years. Advisors to the U.S. Food and Drug Administration had on Tuesday voted overwhelmingly to recommend that the regulator authorize Pfizer and BioNTech's vaccine for younger children.
28th Oct 2021 - Reuters

Pfizer gets U.S. contract for 50 mln COVID-19 vaccine doses for kids

Pfizer Inc and BioNTech SE said on Thursday they expect to deliver 50 million more doses of their COVID-19 vaccine to the U.S. government by April-end, as the country prepares to vaccinate children. The move comes after a panel of outside advisers to the U.S. Food and Drug Administration voted on Tuesday to recommend its authorization for the vaccine in children aged 5 to 11. The agency's decision on the vaccine for the age group is awaited. If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention's (CDC) advisory panel, the companies said they expect to then begin shipping the vaccine immediately, in 10 microgram pediatric doses, as directed by the U.S. government.
28th Oct 2021 - Reuters

Merck sees up to $7 billion in sales of COVID-19 drug through end of 2022

Merck & Co Inc on Thursday said its experimental COVID-19 drug could bring in between $5 billion and $7 billion in sales through the end of next year, assuming it gains U.S. authorization in December. Merck's shares rose more than 4% to $84.88 in early trading. The antiviral drug, molnupiravir, has been closely watched since Merck earlier this month reported data that showed it could halve the chances of dying or being hospitalized for those most at risk of developing severe COVID-19 when given early in the illness.
28th Oct 2021 - Reuters

Israel expected to recognize Russia’s Sputnik V coronavirus vaccine

Israel will likely allow tourists vaccinated with Russia’s Sputnik V coronavirus vaccine to enter Israel next month, The Jerusalem Post has confirmed. The news comes only days after Prime Minister Naftali Bennett met with Russian President Vladimir Putin, and less than a week after an announcement by the Prime Minister’s Office that only travelers inoculated with a vaccine recognized by the US Food and Drug Administration, the European Medicines Agency or the World Health Organization would be able to enter the country. Sputnik V is not approved by any of these bodies.
27th Oct 2021 - The Jerusalem Post

Study: Nearly all severely allergic people tolerate COVID vaccines

While healthcare workers at a Boston healthcare system with severe allergies reported more reactions after receiving a COVID-19 mRNA vaccine, nearly all were able to safely complete the series, according to an observational study yesterday in JAMA Network Open. Researchers at Mass General Brigham and Harvard Medical School mined the electronic health records of 52,998 employees, of whom 97.6% received both doses of vaccine, and 0.9% reported a history of high-risk allergy. The study period was Dec 14, 2020, to Feb 1, 2021. Participants completed a prevaccination allergy risk assessment and at least one postvaccination symptom survey during the 3 days after vaccination.
27th Oct 2021 - CIDRAP

FDA panel recommends Pfizer's COVID-19 vaccine for kids, setting it up for approval

The Pfizer-BioNTech mRNA COVID-19 vaccine is one step closer to winning FDA approval for use in children. But a rousing debate as to whether inoculating kids would reduce transmission of the virus, coupled with some hesitancy from parents, is raising questions about how the approval will impact demand for the shot. A positive recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday set the vaccine up for a green light in the coming days. The panel voted 17-0, with one abstention, to extend the vaccine to kids between the ages of 5 and 11. It would become the first to be approved in the United States for this age group, which includes 28 million kids. The Pfizer dosage for children is one-third the size of that for those age 12 and older. The second of the two-shot series can be administered three weeks after the first.
27th Oct 2021 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 28th Oct 2021

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Breakthrough infections can lead to long COVID; genes may explain critical illness in young, healthy adults

The persistent syndrome of COVID-19 after-effects known as long COVID can develop after "breakthrough" infections in vaccinated people, a new study shows. Researchers at Oxford University in the UK reviewed data on nearly 20,000 U.S. COVID-19 patients, half of whom had been vaccinated. Compared to unvaccinated patients, people who were fully vaccinated - and in particular those under age 60 - did have lower risks for death and serious complications such as lung failure, need for mechanical ventilation, ICU admission, life-threatening blood clots, seizures, and psychosis. "On the other hand," the research team reported on medRxiv on Tuesday ahead of peer review, "previous vaccination does not appear to protect against several previously documented outcomes of COVID-19 such as long COVID features, arrhythmia, joint pain, Type 2 diabetes, liver disease, sleep disorders, and mood and anxiety disorders."
28th Oct 2021 - Reuters

Flu jabs may aid COVID-19 patients who need surgery

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review. Flu-vaccinated COVID-19 patients have easier surgeries. COVID-19 patients who require surgery appear to face fewer complications if they have previously been vaccinated against the flu, new data suggest. In a preliminary study that has not yet undergone peer review, researchers analyzed outcomes after various types of surgery on nearly 44,000 COVID-19 patients worldwide, half of whom had received a flu vaccine in the previous six months
27th Oct 2021 - Reuters

Novavax Covid vaccine submitted to UK regulator for approval

The final data on the Novavax Covid vaccine has been submitted to the UK regulator for approval. The firm behind the vaccine said it anticipates a "positive decision" following the completion of its rolling regulatory submission to the Medicines and Healthcare products Regulatory Agency (MHRA). More than 15,000 people took part in the phase 3 Novavax trial at various hospital sites across the UK. Novavax said its application for conditional marketing authorisation (CMA) marks the first submission for authorisation of a protein-based coronavirus vaccine in the UK.
27th Oct 2021 - Evening Standard

Pfizer to seek Japan approval for children's COVID-19 vaccinations

U.S. pharmaceutical giant Pfizer Inc. is in talks with Japan to apply for approval to administer its COVID-19 vaccine to children aged 5 to 11, sources close to the matter said Wednesday. The revelation came a day after a U.S. Food and Drug Administration (FDA) panel of independent experts voted in favor of issuing emergency use authorization for the vaccine to be administered to children in that age group. If submitted, Japan’s Ministry of Health, Labor and Welfare plans to promptly review the application, according to the sources. Pfizer’s COVID-19 vaccine, jointly developed with German partner BioNTech SE, is currently available free of charge to people aged 12 and older in Japan, where it has been approved for use.
27th Oct 2021 - The Japan Times

Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom

Filing marks first protein-based COVID-19 vaccine submitted to MHRA for authorization. All modules required for regulatory review, including CMC data, are now complete. Submission based on Phase 3 data from ~45K patients demonstrating high efficacy and well-tolerated safety, including against variants Submissions to additional global regulatory authorities including EU, Canada and Australia expected soon
27th Oct 2021 - Business Insider

Merck strikes deal for global access to COVID-19 medication

US drugmaker Merck has announced a deal that could see generic versions of its experimental oral COVID-19 treatment for people infected with the disease widely distributed in poorer countries. The global Medicines Patent Pool (MPP), which is backed by the United Nations, said on Wednesday it had signed a voluntary licensing agreement with Merck to facilitate affordable worldwide access for its antiviral medicine molnupiravir.
27th Oct 2021 - Al Jazeera English

Nine in 10 UK adults likely to still have Covid-19 antibodies

Around nine in 10 adults in all parts of the UK continue to have Covid-19 antibodies, new figures suggest. The estimates range from 90.0% in Wales to 92.2% in England, with 90.8% for Northern Ireland and 91.3% for Scotland. The presence of coronavirus antibodies suggests someone has had the infection in the past or has been vaccinated. It takes between two and three weeks after infection or vaccination for the body to make enough antibodies to fight the virus.
27th Oct 2021 - Belfast Telegraph

Merck agrees to let other drug makers make its COVID pill

Pharmaceutical company Merck agreed to allow other drug makers to produce its COVID-19 pill, in a move aimed at helping millions of people in poorer countries get access to the potentially life-saving drug, a United Nations-backed public health organization said on Wednesday. The Medicines Patent Pool said in a statement that it had signed a voluntary licensing agreement for molnupiravir with Merck and its partner Ridgeback Biotherapeutics. The agreement will allow the Medicines Patent Pool to grant further licenses to qualified companies who are approved to make the drug. Neither drug maker will receive royalties under the agreement for as long as the World Health Organization deems COVID-19 to be global emergency. Molnupiravir is the first pill that has been shown to treat the disease.
27th Oct 2021 - The Associated Press

In a groundbreaking move, Merck and the Medicines Patent Pool ink a licensing deal for a Covid-19 pill

In a notable bid to widen access to Covid-19 remedies, Merck (MRK) has agreed to license its widely anticipated antiviral pill to the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide versions of the drug to 105 low and middle-income countries. The deal builds on a separate agreement that Merck made with eight generic companies that licensed the pill, which is called molnupiravir, in order to make knock-off copies for the same group of countries. The arrangement with the Medicines Patent Pool, however, means that still more manufacturers can now strike so-called sub-licensing deals, which would presumably increase availability more rapidly.
27th Oct 2021 - STAT News

3 takeaways from the emergence of the ‘Delta Plus’ coronavirus variant

Yet another version of the coronavirus is getting global attention, this one dubbed AY.4.2. It appears that it could be slightly more transmissible than the Delta variant — a marginal difference that experts say is more of a headache than a devastating gamechanger in the scope of the pandemic. Still, the emergence of AY.4.2 offers lessons about the ongoing evolution of the pathogen. AY.4.2 has caused some alarm because its prevalence is building up in the United Kingdom, where it’s even gained ground on the remarkably transmissible Delta variant. It now accounts for about 10% of sequenced virus samples in England. Scientists are still trying to determine what, if any, competitive advantage the newer form of the virus has over Delta, and there are a number of possible explanations for AY.4.2’s increasing frequency.
27th Oct 2021 - STAT News

WHO advisors say COVID-19 pandemic far from over

After reviewing the latest COVID-19 developments last week, the World Health Organization (WHO) emergency committee said the pandemic is far from over, though countries are making progress in rolling out vaccines and treatments. The group of outside advisors met on Oct 22 by video conference for the ninth time and unanimously agreed that the situation still warrants a public health emergency of international concern (PHEIC), which was declared on Jan 30, 2020. The group typically meets every 3 months or more often as needed.
26th Oct 2021 - CIDRAP


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 27th Oct 2021

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Australia drugs regulator approves booster doses of Pfizer COVID-19 vaccine

Australia's drugs regulator on Wednesday provisionally approved a booster dose of Pfizer Inc's COVID-19 vaccine for people above 18 years old as first-dose vaccination levels in the country's adult population neared 90%. The booster dose can be administered at least six months after the second shot, the Therapeutic Goods Administration (TGA) said in a statement. Further advice on the use of booster shots will be provided to the federal government soon by the country's vaccination technical advisory group, TGA said.
26th Oct 2021 - Reuters

Moderna Data Shows Covid-19 Vaccine Produced Strong Immune Response in 6- to 11-Year-Olds

Moderna Inc.’s Covid-19 vaccine was generally safe and induced the desired immune responses in children ages 6 to 11 in a clinical trial, according to the company. The Cambridge, Mass., company said Monday that it would submit the results to health regulators in the U.S., Europe and elsewhere in seeking authorization to widen the use of its shots to include this younger age group. The company announced the interim data in a press release, and results haven’t yet been published in a peer-reviewed medical journal. Moderna’s vaccine is currently authorized for use in adults 18 years and older in the U.S.
26th Oct 2021 - The Wall Street Journal

Opinion | Young Kids Should Get the Covid Vaccine. Here’s Why.

Vaccines to protect young children from Covid-19 are likely soon on their way. An advisory panel for the Food and Drug Administration voted overwhelmingly on Tuesday to recommend that the agency authorize the use of the Pfizer-BioNTech Covid-19 vaccine for those ages 5 to 11. Why do we need to vaccinate young children against Covid-19? It’s an understandable question. While many parents have anxiously awaited the opportunity to get their children vaccinated, others are hesitant. There are questions about side effects, as with any drug, especially considering the lower risk of severe disease for children with Covid-19 compared with that of adults. But just because Covid-19 is sickening and killing fewer children than adults does not mean that children are or have been free from risk.
26th Oct 2021 - The New York Times

Pfizer Says Lower-Dose Vaccine for Small Kids Could Also Work for Big Kids

Pfizer Inc.’s lower-dose Covid-19 vaccine for kids under 12 appears to offer protection across the board, company officials said, and the drug giant may look into offering lower doses for teens who now get the adult dose. A scientific advisory panel to the Food and Drug Administration is deliberating Tuesday on whether to recommend the vaccine, which Pfizer makes with partner BioNTech SE, for 5- to 11-year-olds. If cleared by regulators, it would make a Covid-19 vaccine available to all school-age children for the first time. The proposed pediatric dose is 10 micrograms, or a third of the adult Pfizer dose everyone 12 and older currently receives.
26th Oct 2021 - Bloomberg

Becton Dickinson begins selling new at-home rapid COVID-19 test

Becton Dickinson and Co has partnered with Amazon.com Inc to begin shipment of a new at-home rapid COVID-19 test that can confirm results using an entirely automated smartphone app. The BD Veritor At-Home COVID-19 Test, which was authorized by U.S. regulators in August, also automatically reports results to federal and state public health authorities. "One of the unique things about this test is that it's really the very first test to actually have an interpreted digital result," said Dave Hickey, president of Becton Dickinson's life sciences business.
26th Oct 2021 - Reuters on MSN.com

U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

An expert panel on Tuesday voted overwhelmingly to recommend the U.S. Food and Drug Administration authorize the Pfizer Inc (PFE.N) and BioNTech SE COVID-19 vaccine for children ages 5 to 11, saying the benefits of the shot outweigh the risks. An authorization for that age group would be would be an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning. The vaccine could be available to the younger age group as soon as next week. The FDA is not obligated to follow the advice of its outside experts, but usually does. The vote was 17 in favor with one abstention.
26th Oct 2021 - Reuters

FDA to debate authorizing Pfizer’s Covid vaccine for kids aged five to 11

Independent advisers for the US Food and Drug Administration (FDA) on Tuesday recommended the Pfizer-BioNTech Covid vaccine for children aged five to 11 – the first vaccine available for younger children in the US. Of 18 members, 17 voted yes and one abstained. Vaccines for children have been seen as crucial for protecting kids from the virus as well as slowing its spread, in addition to reducing the social and educational effects of school closing and attendance – and related economic concerns, such as caregivers’ ability to work. The advisers weighed the vaccine’s effectiveness, the social and physical effects of the pandemic, and the potential risk of rare side-effects like myocarditis, a type of heart inflammation. Data from Pfizer-BioNTech indicate the vaccine is 90.7% effective at preventing symptomatic illness among this age group.
26th Oct 2021 - The Guardian

S.Korea's GL Rapha certified to produce Sputnik COVID-19 vaccines

South Korean biotech firm GL Rapha has secured regulatory approval from Russia to produce and market the Sputnik family of coronavirus vaccines, the company and Russian sovereign fund RDIF said on Tuesday. The certification paves the way for the first overseas production of the shot to ease a supply shortage and allows GL Rapha to carry out the full production cycle, as opposed to other foreign manufacturers that rely on Russian-supplied ingredients. "This is the first time a foreign production partner of RDIF obtains a Russian GMP (good manufacturing practice) certificate," the two said in a joint statement.
26th Oct 2021 - Reuters

BioNTech to work with Senegal, Rwanda to make mRNA vaccines

Senegal and Rwanda have signed an agreement with German company BioNTech for the construction of its first start-to-finish factories to make messenger RNA vaccines in Africa. BioNTech, which developed the Pfizer-BioNTech COVID-19 vaccine, said Tuesday that construction will start in mid-2022. It is working with the Institut Pasteur in Dakar, Senegal’s capital, and the Rwandan government, a statement said. “State-of-the-art facilities like this will be life-savers and game-changers for Africa and could lead to millions of cutting-edge vaccines being made for Africans, by Africans in Africa,” said Matshidiso Moeti, the World Health Organization’s Regional Director for Africa.
26th Oct 2021 - The Associated Press

Indians await WHO nod for homegrown Covaxin shot to travel abroad

Stuck in a village in southern India for nine months and unable to return to his job in Saudi Arabia, Sugathan PR is hoping the World Health Organization (WHO) will approve the Indian COVID-19 shot Covaxin, paving the way for his trip back. Like Sugathan, millions of Indians have taken Covaxin and many have complained of travel struggles as the vaccine has not been recognised for international travel by several countries.
26th Oct 2021 - AlJazeera

BioNTech to start building mRNA vaccine manufacturing plant in Africa in mid-2022

BioNTech will construct a facility to make its mRNA vaccines in Africa in mid-2022 to scale up production of its COVID-19 jab for a continent that has been largely left behind in the global rollout of vaccines. Planning for the facility has been finalized and “initial assets” have been ordered, the German biotech said Tuesday. That timing sets the Pfizer partner up to potentially beat out Moderna in building the first mRNA vaccine manufacturing site on the continent. Moderna said it plans to pump $500 million into such a facility in Africa, but timing and location were kept under wraps earlier this month. "Mid-2022" is quite vague but at least puts pressure on the company to stick to a publicly disclosed time frame.
26th Oct 2021 - FiercePharma

How Moderna nearly lost the race to develop a Covid-19 vaccine

Moderna Inc. has emerged as a biotech power — and a household name — thanks to its success developing a Covid-19 vaccine. But that outcome hides what happened along the way: The company came perilously close to being the biggest loser in the race for a Covid-19 vaccine. At one point last year, Moderna CEO Stéphane Bancel was overcome with sadness because he thought he had blown the company’s opportunity to produce vaccines to help stop the pandemic. I spent 17 months investigating how the Covid-19 vaccines were developed. I spoke with more than three hundred scientists, academics, executives, government officials, investors, and others who made the Covid-19 vaccines possible. Though developing a safe and effective Covid-19 vaccine in a timeline that many called impossible was a monumental effort, the Moderna story is a stark reminder of how thin the line can be between success and failure.
26th Oct 2021 - Scientific Viewpoint

Moderna says its low-dose Covid vaccine works for kids 6 to 11

Moderna said Monday that a low dose of its Covid-19 vaccine is safe and appears to work in 6- to 11-year-olds, as the manufacturer joins its rival Pfizer in moving toward expanding shots to children. Pfizer’s kid-size vaccine doses are closer to widespread use. They are undergoing evaluation by the Food and Drug Administration for youngsters in nearly the same age group, 5 to 11, and could be available by early November. The company’s vaccine already is authorized for anyone 12 or older. Moderna hasn’t yet gotten the go-ahead to offer its vaccine to teens but is studying lower doses in younger children while it waits.
26th Oct 2021 - STAT News


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 26th Oct 2021

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WHO to consider granting EUL for Bharat Biotech's Covaxin on Tuesday

The World Health Organisation’s (WHO) technical advisory group will consider granting Emergency use listing (EUL) for Bharat Biotech's covid-19 vaccine Covaxin in a meeting scheduled on Tuesday. Soumya Swaminathan, Chief Scientist at WHO said that WHO’s goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere. “The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier," Swaminathan said in a recent tweet. If granted, the approval will hold importance of people in India vaccinated with covaxin as WHO’s approval will facilitate international travel for Indians who have received the home-made vaccine under India’s national covid vaccination programme. The delay has been impacting students and businessmen who want to travel to countries where a vaccination certificate for WHO-approved vaccines is mandatory. As on Monday over 11.70 crores doses of covaxin have been administered in India among different age group above 18. WHO’s EUL is a prerequisite for supplying vaccines under the Covax Facility, a multilateral initiative aimed at fostering global access to covid vaccines. If done, the approval, will also place Covaxin in an important spot in the world map as it can be given to more and more countries.
25th Oct 2021 - Mint

Covid Poses Bigger Risk of Brain Conditions Than Vaccines, Study Says

Covid-19 is more likely to cause rare neurological conditions than vaccines, according to a study published in the Nature Medicine journal. The study, led by the University of Oxford, analyzed the health records of 32 million people in England to identify the risks of developing rare brain conditions before and after testing positive for Covid, or receiving the first dose of either the Oxford-AstraZeneca Plc or Pfizer Inc.-BioNTech SE jabs. The researchers compared how often neurological complications occurred in set windows of time. While the vaccines were found to result in an increase of neurological complications, like Bell’s palsy and Guillain-Barré syndrome, the study found that contracting Covid presented an even bigger risk.
25th Oct 2021 - Bloomberg

EU regulator starts real-time review of Merck's COVID-19 pill

U.S. drugmaker Merck & Co Inc (MRK.N) said on Monday the European Union's drug regulator has initiated a real-time review of its experimental COVID-19 antiviral drug for adults. Under the procedure, also known as a "rolling review", the European Medicines Agency (EMA) would assess data as soon as it becomes available, instead of waiting for a formal application when all required information has been gathered. While vaccines are the main weapons against COVID-19, Merck's experimental pill molnupiravir could be a game-changer after studies showed it could halve the chances of dying or being hospitalised for those most at risk of contracting severe illness.
25th Oct 2021 - Reuters

Moderna says its COVID-19 vaccine protective, safe in young children

Moderna Inc said on Monday its COVID-19 vaccine generated a strong immune response in children aged six to 11 years and that it plans to submit the data to global regulators soon. Moderna said its two-dose vaccine generated virus-neutralizing antibodies in children and safety was comparable to what was previously seen in clinical trials of adolescents and adults. It cited interim data that has yet to be peer reviewed.
25th Oct 2021 - Reuters

Aussie scientist forced to crowd fund homegrown Covid vaccine

Dr Nikolai Petrovsky has been forced to hit GoFundMe to raise cash for Covax-19 It is the first synthetic protein vaccine for Covid to receive market authorisation It costs hundreds of thousands to gain TGA approval to release Covax locally Covax-19 showed strong protection against Delta in a Phase 3 clinical trial
25th Oct 2021 - Daily Mail

First vaccine dose could alleviate long Covid symptoms, study suggests

A first vaccine dose appears to alleviate symptoms in long Covid sufferers, a new study has suggested, although it is unclear whether this improvement lasts until a second dose. People aged 18 to 69 who had received a first dose were 12.8 per cent less likely to report that they were still experiencing persistent symptoms, according to experimental findings published by the Office for National Statistics (ONS). A second dose was associated with a further 8.8 per cent drop, with “statistical evidence” of a sustained improvement afterwards.
25th Oct 2021 - The Independent

Biological E hopes to roll out Covid vaccine Corbevax by Nov-end

Hyderabad-based Biological E Limited (BE) is expecting its coronavirus vaccine Corbevax to be rolled out by the end of November even as the city-based company is getting ready with 100 million doses for the launch, Mahima Datla, Managing Director, BE said today. While speaking to reporters on the sidelines of signing a financing agreement with US International Development Finance Corporation (DFC), Datla said currently the manufactured doses are being sent to Central Drugs Laboratory (CDL), Kasauli in Himachal Pradesh for regulatory testing.
25th Oct 2021 - Mint

Russia approves Sputnik V Covid-19 vaccination with flu shot

Sputnik V has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. The Health Ministry of Russia has reportedly granted approval for administering Covid-19 vaccine Sputnik V and flu shots simultaneously,
25th Oct 2021 - Pharmaceutical Technology

Rural areas, hit hard by COVID-19, lack access to new treatment trials

Three-quarters of rural Americans live more than an hour from the nearest site testing new treatments for COVID-19, research from the University of Virginia School of Medicine reveals. Overall, almost a third of Americans would have to travel more than 60 minutes to access new therapies as they are being tested. This geographic disparity limits access to COVID-19 clinical trials in many parts of the country that are being hit hardest by the latest wave of the pandemic. Native Americans and Alaska Natives are particularly affected, with more than 50% living more than 60 minutes from a trial site.
25th Oct 2021 - EurekAlert!

Doctors are often unaware of the only treatment for early Covid-19

On September 17, Mayra Arana made the phone call she says saved her life. Arana had been vaccinated against Covid-19, but she developed a breakthrough infection. She feared the virus might kill her, since her immune system is weak after years of treatment for leukemia. Arana's family physician in California told her there wasn't much she could do besides stay home and rest. At home, following her doctor's advice, Arana felt sicker by the hour. Her husband placed a pulse oximeter on her fingertip, and it showed her blood oxygen levels were dipping dangerously low.
25th Oct 2021 - CNN

India's Biological E., U.S. body finalise $50 mln COVID-19 shot financing deal

The United States and India's Biological E. Ltd said on Monday they had finalised a financing arrangement for $50 million to expand the vaccine maker's capacity to produce COVID-19 shots. The agreement was struck in March when leaders of the United States, Australia, Japan and India - the so-called "Quad" countries - met during a virtual summit. The United States had said it would work via its International Development Finance Corp to finance Biological E.'s efforts to produce at least 1 billion COVID-19 vaccine doses for India and developing countries by the end of 2022
25th Oct 2021 - Reuters India

S.Africa's Aspen aiming for 1.3 bln dose/year COVID-19 vaccine capacity by 2024

South Africa's Aspen Pharmacare is aiming to ramp up its COVID-19 vaccine manufacturing capacity to 1.3 billion doses a year by February 2024, up from annual output of around 250 million doses now, the company's CEO told Reuters. Aspen is doing the final stages of manufacturing for Johnson & Johnson's COVID-19 vaccine in a so-called "fill and finish" deal, but CEO Stephen Saad said in an interview that the companies were close to announcing a broader deal for Aspen to produce Johnson & Johnson's COVID-19 shot under licence.
25th Oct 2021 - Reuters

Fake, substandard vaccines and medicines spell trouble for controlling Covid-19

A notable rallying cry that emerged early during the Covid-19 pandemic was “flatten the curve.” It reflected the reality that hospitals lacked the resources, knowledge, and therapies to accommodate everyone in need. Nearly 18 months later, the situation around the globe is different. Clinicians have a better understanding of how to prevent Covid-19, and how treat people with severe cases of it. Vaccines have brought much-needed relief. But the picture is now being complicated by the emergence of substandard and falsified Covid-19 vaccines and medical products, which are becoming increasingly pervasive.
25th Oct 2021 - STAT News

Africa tries to end vaccine inequity by replicating its own

In a pair of Cape Town warehouses converted into a maze of airlocked sterile rooms, young scientists are assembling and calibrating the equipment needed to reverse engineer a coronavirus vaccine that has yet to reach South Africa and most of the world’s poorest people. The energy in the gleaming labs matches the urgency of their mission to narrow vaccine disparities. By working to replicate Moderna’s COVID-19 shot, the scientists are effectively making an end run around an industry that has vastly prioritized rich countries over poor in both sales and manufacturing. And they are doing it with unusual backing from the World Health Organization, which is coordinating a vaccine research, training and production hub in South Africa along with a related supply chain for critical raw materials. It’s a last-resort effort to make doses for people going without, and the intellectual property implications are still murky.
25th Oct 2021 - The Associated Press

EU medicines watchdog starts review of Merck COVID pill

The European Medicines Agency (EMA) – the European Union’s top medicines watchdog – has started a review of a potentially ground-breaking antiviral pill to treat COVID-19. The agency announced on Monday that it has launched a “rolling review” of molnupiravir, which was developed by United States pharmaceutical company Merck.
25th Oct 2021 - AlJazeera


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 25th Oct 2021

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‘Darker skies and colder weather provide perfect conditions... for Covid-19 to thrive’

Joe Buglass tried 46 times to call his GP about booking a Covid booster jab last Wednesday. “The phone was just ringing and ringing,” he said. He had tried several times over the previous six weeks, since getting an NHS text message. “You click the link and it gives you the doctors’ surgery number,” he said. Buglass, who runs a property maintenance business in Newcastle, is clinically vulnerable because he donated a kidney. When he finally got through, he was told he was ringing the wrong people. Eventually, someone rang him back. “They told me that because the clinics were finishing this Sunday, they didn’t have any bookings for the next few weeks,” Buglass said. He was incredulous. “Where do I go from here?
24th Oct 2021 - The Guardian

Delta variant ‘descendant’ hits Israel – is it time to panic?

A new and potentially more transmittable version of the Delta variant has entered Israel just as the COVID infection rate has started to decline and the country prepares for flu season. Is the variant known as AY4.2 a reason to sound the alarms? According to the Health Ministry, a single case of AY4.2 was identified in Israel in an 11-year-old boy who recently returned from a trip to Moldova. The boy tested positive for coronavirus while in isolation, the ministry said, and so far, it does not appear that others were infected. However, with AY4.2 being as much as 10% to 15% more transmissible than its Delta grandparent, it is not unlikely that more cases are already in Israel and have just not yet been discovered, said Prof. Cyrille Cohen, head of the immunology lab at Bar-Ilan University.
24th Oct 2021 - The Jerusalem Post

South African Paediatric Association welcomes Covid-19 vaccines opening to young teens

To vaccinate or not? That is the question that parents of children from the age of 12 upwards are asking, now that the youngsters are eligible for Covid-19 jabs. Dr Joe Phaahla, the minister of health announced on Friday that children aged between 12 and 17, will be able to get the one dose of the Pfizer vaccine from Wednesday. He said the decision was taken following recommendations from the Ministerial Advisory Committee (MAC). “We believe that this will come in handy as the schools start their examinations, and for some that have already advanced towards concluding the academic year and studying to prepare for the next academic year,” he said. Those over the age of 18 get two shots of the Pfizer vaccine but the youngsters get a single jab as per recommendations from the South African Health Products Regulatory Authority (SAHPRA).
24th Oct 2021 - Independent Online

Pfizer jab 90% effective in kids

The Pfizer’s Covid-19 vaccine is more than 90 percent effective in preventing symptomatic disease among childen agred 5-to-11, the company said in a document released Friday, that put forward its case for authorisation. The new data was published on the website of the Food and Drug Administration, which has called an advisory panel of independent experts to meet Tuesday to vote on whether to green light the shot.
24th Oct 2021 - Bangalore Mirror

Vaccines alone will not end pandemic, warns WHO

The World Health Organization has warned that the vaccine alone will not be able to lift the world out of the pandemic. WHO Spokesperson Margaret Harris told Times Radio that the problem is focusing on one thing and that the vaccine isn't going to get us out of this. "We really have to do other measures," she said. Ms Harris said people "have got to be serious about not crowding". "We have still got to be looking at wearing the masks, when you're indoors particularly," she said. She added that the rest of the world must be vaccinated to stop new Covid variants from developing.
23rd Oct 2021 - RTE.ie

Here's Why Developing Countries Can Make mRNA Covid Vaccines

Across the developing world, hundreds of millions of people are unable to get a vaccine to protect themselves from the ravages of Covid-19, and millions of them have already become infected and died. Depending on wealthy nations to donate billions of doses is not working, public health experts say. The solution, many now believe, is for the countries to do something that the big American mRNA vaccine makers say is not feasible: Manufacture the gold-standard mRNA shots themselves.
23rd Oct 2021 - The New York Times

Why Some Healthcare Workers Would Rather Lose Their Jobs Than Get Vaccinated

The fact that these holdouts are healthcare workers makes them one of the most confounding challenges for the vaccination drive. Around one-third of the eligible population in the U.S. remains unvaccinated against Covid-19. Some of the vaccine holdouts, health officials believe, will ultimately be persuaded to get the shot—the so-called movable middle. Others might never be persuaded. Their resistance and potential influence threaten public-health efforts to defeat the virus, say epidemiologists and other health experts.
23rd Oct 2021 - The Wall Street Journal

FDA says benefits outweigh risks for Pfizer/BioNTech COVID-19 vaccine in children

Scientists at the U.S. Food and Drug Administration (FDA) said on Friday that the likely benefits of giving the Pfizer/BioNTech COVID-19 vaccine to 5 to 11 year olds clearly outweigh the risks of rare cases of heart inflammation. Earlier on Friday, the vaccine makers said their shot showed 90.7% efficacy against the coronavirus in a clinical trial of children 5 to 11 years old.
23rd Oct 2021 - Reuters

Sinovac added to S'pore national vaccination programme: 5 questions about the vaccine answered

The Sinovac Covid-19 vaccine will be included in the national vaccination programme to cater to individuals aged 18 years and above who are unable or unwilling to take the Pfizer-BioNTech or Moderna mRNA vaccines. The Ministry of Health said that three doses of the Sinovac vaccine will be required for a person to be considered fully vaccinated. The second dose should be taken 28 days after the first dose, while the third dose should be taken 90 days after the second dose.
23rd Oct 2021 - The Straits Times

Namibia to suspend use of Russian COVID-19 vaccine - ministry

Namibia will suspend its rollout of Russia's Sputnik V COVID-19 vaccine, its health ministry said on Saturday, days after the drugs regulator in neighbouring South Africa flagged concerns about its safety for people at risk of HIV. The Gamaleya Research Institute, which developed Sputnik V, said Namibia's decision was not based on any scientific evidence or research. South African regulator SAHPRA decided not to approve an emergency use application for Sputnik V for now because, it said, some studies suggested that administration of vaccines using the Adenovirus Type 5 vector - which Sputnik V does - was associated with higher susceptibility to HIV in men.
23rd Oct 2021 - Reuters


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 22nd Oct 2021

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Pfizer-BioNTech Covid-19 Booster Shot Was 95.6% Effective in Large Trial, Companies Say

A third dose of the Covid-19 vaccine from Pfizer Inc.and BioNTech SE was found in a large study to be highly protective against symptomatic Covid-19, the companies said Thursday. Researchers found 109 cases of symptomatic Covid-19 among study subjects who received a placebo shot, compared with five cases in people who took the vaccine, resulting in 95.6% efficacy, the companies said. The additional dose was safe and tolerable, and consistent with what was known about the vaccine, the companies said. The study was carried out while the highly contagious Delta variant was prevalent, the companies said, suggesting the booster helps protect against the contagious strain.
22nd Oct 2021 - The Wall Street Journal

Pfizer vaccine 90% effective in warding off COVID in adolescents

The Pfizer vaccine is highly effective against preventing coronavirus in adolescents, a new Israeli study published overnight Wednesday in the New England Journal of Medicine showed. The research, which focused on youth between the ages of 12 and 18, was carried out by Clalit Health Services. It found that the vaccine was 90% effective against warding off infection and 93% effective against stopping symptomatic infection on days seven to 21 after the second dose, even against the Delta variant.
21st Oct 2021 - The Jerusalem Post

COVID vaccine makers brace for a variant worse than Delta

Pfizer’s chief executive, Albert Bourla, made a bold promise in June. Standing next to US President Joe Biden at a press conference in St Ives, UK, just before the G7 summit meeting, Bourla said that should the need arise for a new COVID-19 vaccine, his company could get one ready within 100 days. The need he was referring to is the possible emergence of an ‘escape variant’ — a dominant strain of SARS-CoV-2 that evades the fledgling immunity established through vaccines and previous infections. No such strain has yet been identified, but Pfizer and other leading COVID-19 vaccine makers are gearing up for that scenario. What does it take to be nimble enough to design and test an updated vaccine against an unknown viral strain, in record time? Nature spoke to three COVID-19 vaccine makers — Pfizer, Moderna and AstraZeneca — to find out exactly how they are preparing.
21st Oct 2021 - Nature

EU decision on Russia's Sputnik V shot 'impossible' this year - source

The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until at least the first quarter of 2022 because some data needed for the review is still missing, a source with knowledge of the matter said. "An EMA decision by the end of the year is now absolutely impossible," the source said, referring to the European Medicines Agency. If the required data is received by the end of November, "then the regulators may well decide in the first quarter of next year", he said.
21st Oct 2021 - Reuters

Schools should stay open as greatest risk of Covid transmission is in households, research finds

Despite Delta being more transmissible than earlier Covid-19 variants, in Australia few children and adolescents who get the virus have severe symptoms, and schools should only be closed under exceptional circumstances, a research analysis from the Murdoch Children’s Research Institute has found. However, the analysis reveals children and adolescents living with some pre-existing health conditions, including obesity, and those living in disadvantage, low socioeconomic communities or those with minority ethnic status have an increased risk of severe disease. The analysis also said ventilation is important and mental health surveillance is needed across both primary and secondary schools.
21st Oct 2021 - The Guardian

U.S. FDA clears Moderna, J&J COVID-19 boosters, backs use of different vaccine for boost

The U.S. Food and Drug Administration authorized booster doses of the COVID-19 vaccines from Moderna and Johnson & Johnson, and said Americans can choose a different shot from their original inoculation as a booster. That means all three vaccines authorized in the United States can also be given as boosters to some groups. "The availability of these authorized boosters is important for continued protection against COVID-19 disease," acting FDA Commissioner Janet Woodcock said in a statement. She noted that data suggests vaccine effectiveness may wane over time in some fully vaccinated people.
21st Oct 2021 - Reuters

Japan's Shionogi starts Phase II/III clinical trial for new COVID-19 vaccine

Japan' Shionogi & Co said it had started a Phase II/III clinical trial for its COVID-19 vaccine candidate. The trial for the recombinant protein-based vaccine will take place in Japan and follows a Phase I trial in the country, Shionogi said in a statement. The company will also prepare to conduct multiple trials globally, it said.
21st Oct 2021 - Reuters

UK adds nerve disorder as rare side-effect of AstraZeneca COVID-19 vaccine

The UK drug regulator added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), as a very rare side effect of the AstraZeneca COVID-19 vaccine, updates on the agency's website showed on Thursday. Medicines and Healthcare products Regulatory Agency's (MHRA) decision comes after the European medicines agency added GBS as a possible side-effect last month
21st Oct 2021 - Reuters

CDC Panel Endorses Moderna and J.&J. Boosters for Millions

In a sweeping victory for the Biden administration, the Centers for Disease Control and Prevention on Thursday endorsed booster shots of the Moderna and the Johnson & Johnson Covid-19 vaccines for tens of millions of Americans. The decision follows an agency endorsement last month of booster shots of the Pfizer-BioNTech vaccine and opens the door for many Americans to seek out a booster shot as early as Friday. The coronavirus vaccines “are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Rochelle Walensky, director of the C.D.C. said in a statement on Thursday night.
21st Oct 2021 - The New York Times

Pfizer-BioNTech report high efficacy of COVID boosters in study

Pfizer and its partner BioNTech have said data from a Phase III trial demonstrated high efficacy of a booster dose of their COVID-19 vaccine against the coronavirus, including the Delta variant. They said a trial of 10,000 participants aged 16 or older showed 95.6 percent effectiveness against the disease, during a period when the Delta strain was prevalent. The study also found that the booster shot had a favourable safety profile.
21st Oct 2021 - AlJazeera

Moderna, Johnson & Johnson COVID boosters nab FDA nods as agency backs 'mix-and-match' approach

The FDA has authorized a booster dose of Moderna's COVID-19 vaccine, allowing it to play catch up with the Pfizer-BioNTech shot, which scored a booster approval last month. The agency also blessed a second dose of the Johnson & Johnson vaccine. That nod applies to adults who have received one J&J shot two months prior. “The currently available data suggest waning immunity in some populations of fully vaccinated people,” FDA acting commissioner Janet Woodcock told reporters on Wednesday night. “The availability of these authorized boosters is important for continued protection against COVID-19.”
21st Oct 2021 - Fierce Pharma

Pfizer strong-armed governments in COVID-19 vaccine supply talks, report says

Pfizer is playing a leading role in producing vaccines against COVID-19, but new documents released by Public Citizen shine a light on the company's aggressive tactics when negotiating supply deals. In draft and final deals with the U.S., the U.K., Brazil and other countries, Pfizer retained rights to "silence" governments and "throttle supply" in an effort to "maximize profits" amid the world's "worst public health crisis in a century," Public Citizen concluded. For instance, in a deal with Brazil, Pfizer restricted the government from making “any public announcement concerning the existence, subject matter or terms of [the] Agreement” without a signoff from the drugmaker. Brazil also couldn't talk about the country's relationship with Pfizer without a signoff, Public Citizen said.
20th Oct 2021 - Fierce Pharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 21st Oct 2021

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Gates Foundation to spend $120 mln to speed access to generics of Merck COVID-19 pill

The Bill & Melinda Gates Foundation said on Wednesday it would spend up to $120 million to kick-start development of generic versions of Merck & Co's (MRK.N) oral COVID-19 treatment to help ensure lower-income countries have equal access to the drug. The aim is to reduce the gap between when wealthy countries have access to the antiviral medicine, molnupiravir, and when the rest of the world can benefit from it. "To end this pandemic, we need to ensure that everyone, no matter where they live in the world, has access to life-saving health products," Melinda French Gates, co-chair of the Gates Foundation, said in a statement
20th Oct 2021 - Reuters

Poland to make COVID booster shots available to all adults

Poland is planning to make third doses of the coronavirus vaccine available to all adults "over the next few weeks", Prime Minister Mateusz Morawiecki said on Wednesday. "Those over 18 who had their last dose at least six months ago will be able to get another dose," Morawiecki said in a Facebook post. The country reported more than 5,000 daily new infections on Thursday for the first time since May amidst a surging fourth wave of the coronavirus pandemic.
20th Oct 2021 - Reuters

‘Vital’ at-home Covid pills could be given to vulnerable people this winter

Antiviral drugs that help to cut the risk of hospitalisation and death from Covid could be made available to vulnerable people this winter. It’s hoped the pills will be made available to the elderly and those with weakened immune systems who have recently tested positive for the virus or come into contact with an infected individual. Patients would take the drug at home, ideally before they fall ill. The antivirals, provided by Merck and Pfizer, have been secured in a government deal. But they will need to be approved for use by the UK’s medicines regulator before they are offered to patients via the NHS. Eddie Gray, chair of the antivirals taskforce, said the pills would help to support the NHS and the UK’s vaccination programme over the coming months, with infections and hospitalisations expected to further rise.
20th Oct 2021 - The Independent

Waning vaccine immunity helping drive up UK infections, suggesting herd immunity unreachable, say scientists

Waning immunity from vaccines is a key cause of rising infections – but it is not the only factor, scientists say. The number of new Covid infections recorded in the past week has increased by 16 per cent against a backdrop of falling immunity among those who received their second jab a few months or longer ago. A growing number of studies have found that immunity begins to fall within a few months, although jabs continue to provide good protection, especially from more severe cases.
20th Oct 2021 - iNews

South African regulator rejects Russia's COVID-19 vaccine

The South African drug regulator has rejected the Russia -made coronavirus vaccine Sputnik V, citing some safety concerns the manufacturer wasn't able to answer. The South African Health Products Regulatory Authority, or SAHPRA, said in a statement Tuesday that the request for Sputnik V to be authorized could “not be approved at this time,” referring to past failed HIV vaccines that used a similar technology. A late-stage study published in the journal Lancet last year in more than 20,000 participants found that Sputnik V was safe and about 91% effective in preventing people from becoming severely ill with COVID-19.
20th Oct 2021 - The Independent

Deaths among the double vaccinated: what is behind the Australian statistics?

On Tuesday, there were 356 Covid-19 patients being treated in intensive care wards throughout Australia. Of those, 25 were fully vaccinated. While the data points to the extraordinary efficacy of Covid-19 vaccines in preventing people from becoming severely unwell, being hospitalised and dying, it does raise the question: why do a small number of people become seriously ill and, in rare cases, die, despite being fully vaccinated? An intensive care unit staff specialist at Nepean hospital in Sydney, Dr Nhi Nguyen, said those who are fully vaccinated and die tend to have significant underlying health conditions. Being treated in intensive care, where people may be on a ventilator and unable to move, added to any existing frailty, especially in elderly people, she said.
20th Oct 2021 - The Guardian

Without Covid-19 jab, 'reinfection may occur every 16 months'

As Covid-19 infections surge in England, people are increasingly reporting catching Sars-CoV-2 for a second or even third time. New analysis has suggested that unvaccinated individuals should expect to be reinfected with Covid-19 every 16 months, on average. With winter approaching, scientists are warning that such reinfections could add to the burden on the NHS, some calling for the vaccination programme to be extended to all schoolchildren, including two doses for teenagers. “If you’ve got high-level prevalence, and frequent exposure to the virus, as you have in schools, you are going to see more and more people getting reinfected despite having been double vaccinated,” said Stephen Griffin, associate professor of virology at the University of Leeds.
20th Oct 2021 - The Guardian

Trials find no benefit of interferon, colchicine in COVID hospital patients

New clinical trials detail the failure of two COVID-19 treatments—a combination of interferon beta-1a and remdesivir and the drug colchicine—to reduce death by 28 days, length of hospital stay, or risk of requiring invasive mechanical ventilation or dying in hospitalized adults.
20th Oct 2021 - Scientific Viewpoint

Gates Foundation will provide $120 million to ensure generic production of Merck’s Covid-19 pill

As concern mounts over access to Covid-19 remedies, the Bill & Melinda Gates Foundation is committing up to $120 million to accelerate production of generic versions of an experimental Merck (MRK) pill to treat Covid-19 that would be available to dozens of low-income countries. But the effort was greeted with mixed reactions by patient advocates. The Gates Foundation plans to provide different types of incentives so that eight generic manufacturers, all of which have already signed voluntary licensing deals with Merck, will be positioned to produce a sufficient quantity of the drug, called molnupiravir, as quickly as possible. The goal is to convince the generic companies to ready their facilities rather than wait to gauge demand for the pill — which early data suggests could reduce hospitalizations and deaths — before ramping up.
20th Oct 2021 - STAT News

Sex of the fetus influences the mother’s response to Covid-19 infection, new research shows

In two studies published Tuesday in Science Translational Medicine, the Boston-based research teams found that pregnant and lactating women mount robust antibody responses to both vaccination and infection. The encouraging data also came with some twists that offer intriguing new clues to one of the pandemic’s enduring mysteries: why Covid-19 hits male adults, children, and infants harder than females. “What’s striking here is that the mothers who are carrying male babies have much lower levels of antibodies to the coronavirus,” said Akiko Iwasaki, a virologist and immunologist at Yale University who was not involved in the study. “What’s interesting about that is it means that the sex of the baby can dictate how the mother responds to a viral infection.”
20th Oct 2021 - STAT News

Covid Cases Are Soaring in Britain Again. Why?

Once again Britain has one of the highest rates of Covid infection anywhere. The U.K. just reported its biggest single day Covid case increase in three months and a 16% increase in confirmed cases in the week to Oct. 18. The government has warned of a bad winter. Even in the era of vaccines, the risks aren’t trivial. While deaths from Covid are now mercifully low, some of those who get infected will end up hospitalized. They will suffer, and occupy beds and health service resources that are already overstretched and coping with a gargantuan backlog of cases. Families will step in; productivity will be lost. Others will end up with Long Covid, whose symptoms last for weeks or months after the virus has cleared. High levels of infection will also increase the risk of new vaccine-resistant strains of the virus.
20th Oct 2021 - Bloomberg


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 20th Oct 2021

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Pfizer/BioNTech COVID-19 vaccine highly protective in 12-18 age group - U.S. CDC study

The Pfizer Inc/BioNTech SE COVID-19 vaccine was 93% effective in preventing hospitalizations among those aged 12 to 18, according to an analysis released by the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday. The study was conducted between June and September, when the extremely contagious Delta variant of the coronavirus was predominant. Yet, the data from 19 pediatric hospitals showed that among the 179 patients who were hospitalized for COVID-19, 97% were unvaccinated, providing reassurance of the vaccine's efficacy.
19th Oct 2021 - Reuters

WHO defends delay in approving India’s Covaxin jab: ‘We are aware that many are waiting’

The World Health Organisation has defended its decision to delay the approval of India’s homemade coronavirus vaccine Covaxin and said that it cannot cut corners in its process. The international health body said that it was looking for “one additional piece of information” from Bharat Biotech, the Hyderabad-based company which created the vaccine. The vaccine, which was India’s first indigenously made Covid jab, is one of three currently being used in the country’s Covid-19 inoculation drive. India’s drugs control body had approved the restricted emergency use of Covaxin in January. It accounts for 11 per cent of the 980 million doses administered in the country so far.
19th Oct 2021 - The Independent

Oxford scientists working on new Covid vaccine to target Delta variant

A new and modified version of the Oxford vaccine is being developed to target the Delta coronavirus variant, The Independent understands. Early work has been started by members of Professor Dame Sarah Gilbert’s team at the University of Oxford – the same scientists behind the AstraZeneca jab first rolled out in January. A source told The Independent the new vaccine was being designed with the aim of “having something on the shelf ready to scale up – if it’s needed”. Although the UK’s vaccine programme was singled out as a success in a recent report which largely condemned the government for its handling of Covid-19, scientists have insisted there is still more to be done in better protecting the nation, with large pockets of the population and certain communities still not fully vaccinated.
19th Oct 2021 - The Independent

Atea plunges after COVID-19 treatment fails to help patients in study

Atea Pharmaceuticals Inc's experimental COVID-19 antiviral pill, being developed with Roche, failed to help patients with mild and moderate COVID-19 in a small study of mostly low-risk patients, driving the U.S. drugmaker's shares down more than 65% on Tuesday. The trial results puts Atea and Roche far behind U.S.-based Merck & Co Inc (MRK.N) in the race to a pill to treat COVID-19.
19th Oct 2021 - Reuters

Covid-19: New mutation of Delta variant under close watch in UK

Officials are keeping a close watch on a new descendant of the Delta variant of Covid that is causing a growing number of infections. Delta is the UK's dominant variant, but latest official data suggests 6% of Covid cases that have been genetically sequenced are of a new type. AY.4.2, which some are calling "Delta Plus", contains mutations that might give the virus survival advantages. Tests are under way to understand how much of a threat it may pose. Experts say it is unlikely to take off in a big way or escape current vaccines.
19th Oct 2021 - BBC News

US expected to authorize mix-and-match COVID booster shots

Federal regulators are expected to authorize the mixing and matching of COVID-19 booster doses this week in an effort to provide flexibility as the campaign for extra shots expands. The upcoming announcement by the Food and Drug Administration is likely to come along with authorization for boosters of the Moderna and Johnson & Johnson shots and follows the OK for a third dose for the Pfizer vaccine for many Americans last month. The move was previewed Tuesday by a U.S. health official familiar with the matter who was not authorized to speak publicly ahead of the announcement. The FDA was expected to say that using the same brand for a booster was still preferable, especially for the mRNA vaccines from Pfizer and Moderna that have proved most effective against the coronavirus. The agency was still finalizing guidance for the single-shot J&J vaccine.
19th Oct 2021 - The Associated Press

Does getting the flu with COVID double your risk of death?

Globally, an estimated 290,000 to 650,000 people typically die each year from seasonal flu. Last year, however, was different. The northern hemisphere winter of 2020-21 saw some of the lowest recorded flu death rates. Scientists believe this was mainly due to restrictions put in place at the height of the COVID-19 pandemic, most notably less mixing of people in indoor spaces, social distancing, mask wearing and hand washing. Many countries, including the United Kingdom, also saw record numbers of people come forward for the flu vaccine during this time – motivated in part by fears of contracting COVID and flu at the same time. The result was fewer flu cases, hospitalisations, and deaths compared with previous flu seasons. But as most of the developed world is now fully vaccinated against COVID, and governments are focused on reversing some of the economic damage of the pandemic, many social distancing measures have been lifted. In England alone, despite nearly 40,000 new cases of COVID per day, almost all protective measures to reduce the risk of transmission of the disease have been lifted.
19th Oct 2021 - The Guardian

Atea’s antiviral pill fails to clear Covid-19, forcing a re-think

Atea Pharmaceuticals said Tuesday that its antiviral pill for Covid-19 failed to combat the virus in a mid-stage trial, leading the company to delay its pivotal study by a year. The disappointing news follows a far more hopeful October update from Merck, whose similar antiviral reduced the chances that patients newly diagnosed with Covid-19 would be hospitalized by about 50% in a Phase 3 study. There is a desperate need for treatments for early Covid that can be taken as pills. Current treatments, such as remdesivir and monoclonal antibodies, are generally given intravenously or as injections, and are difficult to distribute to large numbers of people. The hope is that pills to treat Covid could be given widely in order to prevent infected people from progressing to severe disease, hospitalization, or death.
19th Oct 2021 - STAT News

Mix-and-Match Covid Boosters: Why They Just Might Work

Immunizations typically consist of two or more doses of the same vaccine. The Moderna vaccine, for example, is administered in two identical shots of mRNA, separated by four weeks. A double dose can create much more protection against a disease than a single shot. The first dose causes the immune system’s B cells to make antibodies against a pathogen. Other immune cells, called T cells, develop the ability to recognize and kill infected cells. The second shot amplifies that response. The B cells and T cells dedicated to fighting the virus multiply into much bigger numbers. They also develop more potent attackers against the enemy.
19th Oct 2021 - The New York Times

Why COVID boosters weren’t tweaked to better match variants

More COVID-19 booster shots may be on the way -- but when it’s your turn, you’ll get an extra dose of the original vaccine, not one updated to better match the extra-contagious delta variant. And that has some experts wondering if the booster campaign is a bit of a missed opportunity to target delta and its likely descendants. “Don’t we want to match the new strains that are most likely to circulate as closely as possible?” Dr. Cody Meissner of Tufts Medical Center, an adviser to the Food and Drug Administration, challenged Pfizer scientists recently.
18th Oct 2021 - The Associated Press

Pharma FDA delays decision on Moderna's COVID-19 vaccine in 12-17 age group because of myocarditis concerns: WSJ

After reports in four Nordic countries of the heart inflammation condition myocarditis, the FDA has delayed a decision on the Moderna COVID-19 shot for kids between the ages of 12 to 17, The Wall Street Journal reports. This month the shot was closing in on a nod, the newspaper reports, but now officials are taking a closer look at the vaccine's safety profile. The move comes after four countries—Denmark, Finland, Norway and Sweden—recommended against use of the Moderna shot by those under the age of 30. Some countries have said that young people should instead get the Pfizer vaccine. The concerns could lead the Pfizer shot to become the vaccine of choice for kids in that age group in the U.S. The company won FDA authorization for the 12 to 15 age group in May and has steered largely clear of myocarditis concerns in recent weeks. More than 12 million people ages 12 to 17 in the United States have received the Pfizer vaccine, according to the CDC.
18th Oct 2021 - FiercePharma

Pfizer, Moderna will rake in a combined $93 billion next year on COVID-19 vaccine sales: report

If you think Pfizer-BioNTech and Moderna are making a fortune on COVID-19 vaccine sales this year, just wait for 2022. The messenger RNA shot producers are projected to break the bank next year, generating combined sales of $93.2 billion, nearly twice the amount they are expected to rake in this year, says Airfinity. The health data analytics group puts total market sales for COVID-19 vaccines in 2022 at $124 billion, according to data seen by The Financial Times. Pfizer vaccine sales will reach $54.5 billion in 2022 and Moderna’s will hit $38.7 billion, Airfinity predicts. The estimates blow the consensus figures of $23.6 billion for Pfizer and $20 billion for Moderna out of the water.
18th Oct 2021 - FiercePharma


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 19th Oct 2021

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US to Consider Boosting J&J Vaccines With Pfizer or Moderna Shots, Fauci Says

President Joe Biden’s chief medical adviser said he expects U.S. regulators to consider whether people who got the one-dose Johnson & Johnson vaccine should get an mRNA shot against Covid-19 as a booster. “If you boost people who have originally received J&J with either Moderna or Pfizer, the level of antibodies that you induce in them is much higher than if you boost them with the original J&J,” Anthony Fauci said on ABC’s “This Week” on Sunday. “But the data of boosting the J&J first dose with a J&J second dose is based on clinical data,” he said. “So what’s going to happen is that the FDA is going to look at all those data, look at the comparison, and make a determination of what they will authorize.”
18th Oct 2021 - Bloomberg

U.K. Covid Surge Sparks Call for Probe Into Delta Plus Mutation

Former U.S. Food and Drug Administration Commissioner Scott Gottlieb called for “urgent research” into a mutation of the delta variant -- known as delta plus -- following a surge in Covid-19 cases in the U.K. “We need urgent research to figure out if this delta plus is more transmissible, has partial immune evasion,” Gottlieb said in a tweet. “There’s no clear indication that it’s considerably more transmissible, but we should work to more quickly characterize these and other new variants. We have the tools.”
18th Oct 2021 - Bloomberg

Covid-19 news: Valneva reports positive results from vaccine trial

A covid-19 vaccine made by Valneva produced stronger antibody responses and fewer side effects than the Oxford/AstraZeneca vaccine in a clinical trial, the French company has announced. The trial included more than 4600 participants in the UK, who were randomly allocated one of the two vaccines, while delta was the predominant coronavirus variant in circulation. The rate of covid-19 cases was similar in the two groups and no participants developed severe illness from covid-19. Valneva’s experimental vaccine, VLA2001, consists of inactivated whole virus particles, in combination with two adjuvants – drugs given to augment the immune response. “This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe and North America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic,” said Adam Finn at the University of Bristol, UK, chief investigator for the trial, in a press release.
18th Oct 2021 - New Scientist

Why COVID boosters weren't tweaked to better match variants

More COVID-19 booster shots may be on the way -- but when it’s your turn, you’ll get an extra dose of the original vaccine, not one updated to better match the extra-contagious delta variant. And that has some experts wondering if the booster campaign is a bit of a missed opportunity to target delta and its likely descendants. “Don’t we want to match the new strains that are most likely to circulate as closely as possible?” Dr. Cody Meissner of Tufts Medical Center, an adviser to the Food and Drug Administration, challenged Pfizer scientists recently. “I don’t quite understand why this is not delta because that’s what we’re facing right now,” fellow adviser Dr. Patrick Moore of the University of Pittsburgh said last week as government experts debated whether it’s time for Moderna boosters. He wondered if such a switch would be particularly useful to block mild infection.
18th Oct 2021 - The Associated Press

What Scientists Know About the Risk of Breakthrough Deaths

The death of former Secretary of State Colin L. Powell on Monday from complications of Covid-19 has provided fuel for vaccine skeptics and opponents, who immediately seized on the news that Mr. Powell had been vaccinated to stoke doubts about the effectiveness of the vaccines. But Mr. Powell’s immune system had most likely been weakened by multiple myeloma, a cancer of white blood cells. Both the disease and the treatment can make people more susceptible to infections. His age, 84, may also have increased his risk, scientists said. Mr. Powell received his second dose of the Pfizer-BioNTech vaccine in February, said Peggy Cifrino, his longtime aide. He had been scheduled for a booster last week but fell ill before he received it, she said.
18th Oct 2021 - The New York Times

Valneva reports positive results from Covid-19 vaccine trial

French pharmaceutical firm Valneva – whose UK contract for vaccines was cancelled last month – has reported positive results from its Covid-19 trial. Last month, the UK Government scrapped a deal for Valneva’s Covid-19 vaccine, with the firm saying the UK Government had served notice over allegations of a breach of the agreement, which Valneva “strenuously” denied. The UK had about 100 million doses on order and Prime Minister Boris Johnson visited Valneva’s Scottish manufacturing site in Livingston in January.
18th Oct 2021 - Belfast Telegraph

The WHO is letting down long Covid patients

It is unclear why the WHO definition snubs and does not embrace the term “long Covid”. The term was coined by patients who also refer to themselves as long-haulers. These patients-advocates-researchers galvanized attention around the existence of this disease and brought long Covid to the spotlight. In a short few months, they created a formidable patient-led advocacy and research movement that changed the arc of medical history. They were the first to survey their membership and catalogue the broad array of clinical problems caused by Covid-19. Their contributions will go down in the annals of history as an important inflection point.
18th Oct 2021 - The Guardian

South Africa regulator not authorising Russian COVID-19 vaccine for now

South Africa's drugs regulator said on Monday that it was not approving an emergency use application for Russia's Sputnik V COVID-19 shot for now, citing concerns about its safety for people at risk of HIV.
18th Oct 2021 - Reuters

WHO expects more information from India's Bharat Biotech for its COVID-19 vaccine

The World Health Organization on Monday asked for further data from India's Bharat Biotech to consider the company's request for an emergency-use listing for its COVID-19 shot, saying the WHO could not "cut corners" in making a decision. Bharat Biotech, which developed Covaxin with an Indian state research body, started sharing data with the WHO from early July. The vaccine was given emergency-use authorisation in India in January even before the completion of a late-stage trial, which later found the shot to be 78% efficacious.
18th Oct 2021 - Reuters

Doctor who advocated Covid-19 therapy including ivermectin applied for patent on same unproven treatment

A Sydney gastroenterologist who has been enthusiastically promoting an unapproved Covid-19 treatment, including to Australian politicians and general practitioners, has filed a patent in the US for the same treatment, allowing him to commercialise and profit from it, if approved. Prof Thomas Borody has been quoted in medical newsletters and publications, and in news outlets including the Financial Review, the Daily Telegraph and the Australian, promoting what he describes as a “triple therapy protocol” to treat and cure Covid-19. The protocol involves a combination of the anti-parasitic drug ivermectin, zinc and the antibiotic doxycycline. In December 2020 Borody filed a patent in the US for therapeutic combinations of drugs, including a combination of ivermectin, an antibiotic and zinc. Patenting a treatment means the owner of the patent is allowed to exclusively manufacture, market and profit from the drug until the patent expires, usually after 20 years.
18th Oct 2021 - The Guardian


Scientific Viewpoint - COVID-19 Lockdown Exit Analysis - 18th Oct 2021

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CDC data: Unvaccinated 11 times more likely to die from COVID-19 than fully vaccinated | TheHill

Unvaccinated people have an 11 times higher risk of dying from COVID-19 than fully vaccinated people, according to new data posted by the Centers for Disease Control and Prevention (CDC). The data run through August and are from 16 health departments representing about 30 percent of the U.S. population, the CDC said. In addition, the data show that unvaccinated people have a six times higher chance of testing positive for COVID-19 than fully vaccinated people do.
17th Oct 2021 - The Hill

Will New Covid Treatments Be as Elusive for Poor Countries as Vaccines?

Nearly a year after the first Covid-19 vaccination campaigns began, the vast majority of the shots have gone to people in wealthy nations, with no clear path toward resolving the disparity. News this month that an antiviral medication had proved effective against the coronavirus in a large clinical trial has brought new hope of a turning point in the pandemic: a not-too-distant future when a simple pill could keep infected people from dying or falling severely ill. The drug, molnupiravir, made by Merck, is easy to distribute and can be taken at home. The trial results showed it halved the risk of hospitalization and death among high-risk people early in their infections.
17th Oct 2021 - The New York Times

Studies show that mask-wearing reduces Covid-19 outbreaks in schools

New studies by the Centers for Disease Control and Prevention (CDC) show that US counties with masking policies in place in their schools have a lower risk of Covid-19 outbreaks compared to counties that do not have masking policies. The United States-based research assessed the impact of masking in schools on new Covid-19 cases in learners from kindergarten to grade 12 across the country. The CDC examined the difference between paediatric Covid-19 case rates in schools with and without school mask requirements. The researchers used data from 1 July to 4 September 2021. The researchers developed inclusion criteria that the schools had to meet to be part of the study. This included a valid school start date in districts with known school mask requirements, a uniform mask requirement for all learners and at least three weeks with seven full days of case data after the beginning of the school year.
16th Oct 2021 - News24

South Africa just hit 20 million vaccinations. Here is how that compares globally.

On Friday, South Africa reached 20 million administered doses of Covid-19 vaccine. Somewhat over a quarter of the adult population is fully vaccinated for the coronavirus. Globally, more than 6.6 billion doses have now been administered, and the proportion of the world population fully vaccinated is fast approaching 40%.
16th Oct 2021 - Business Insider South Africa

Slightly more than half of migrant workers in Jurong dorm vaccinated or have verified status, says MOM

Fifty-five per cent of the migrant workers at Westlite Jalan Tukang dormitory have verified their vaccination status or have been vaccinated against COVID-19 as of Saturday (Oct 16), the Ministry of Manpower (MOM) said. The remaining 45 per cent are pending verification or have yet to receive a Pandemic Special Access Route (PSAR) or World Health Organization Emergency Use Listing Procedure (WHO EUL) vaccine, said MOM in a statement on Saturday. The two PSAR-approved vaccines are the ones made by Pfizer-BioNTech and Moderna. These are also among the WHO EUL vaccines, which include AstraZeneca, Johnson & Johnson, Sinopharm, Sinovac and Covishield.
16th Oct 2021 - CNA

Songkhla adopts stricter Covid screening

Authorities in Songkhla have toughened screening measures in areas adjacent to the three southernmost border provinces in hopes of bringing down stubbornly high rates of Covid-19 infections. People travelling from Pattani, Yala and Narathiwat will have to show proof of coronavirus vaccination, negative test results or other documents if they wish to enter Songkhla, governor Jetsada Jittarat said on Saturday. Songkhla on Saturday reported 621 new coronavirus cases, the third highest in the country behind Bangkok (1,077) and Yala (664). The new infections raised the cumulative provincial total to 39,296, with deaths at 171. The number of daily infections in Songkhla has been between 400 and 600 a day, which is partially a reflection of high levels of mass testing by health workers in many areas.
16th Oct 2021 - Bangkok Post

Second J&J COVID shot gets expert backing; FDA looking at lowering age for Pfizer booster

Outside advisers to the U.S. Food and Drug Administration on Friday unanimously recommended the agency authorize a second shot of Johnson & Johnson's COVID-19 vaccine for all recipients of the one-dose inoculation. The agency is also considering lowering the recommended age for booster shots of the Pfizer/BioNTech vaccine to people as young as 40, FDA official Dr. Peter Marks told the advisory panel. The FDA's Vaccines and Related Biological Products Advisory Committee backed the shots for all J&J recipients aged 18 and older at least two months after their first dose.
15th Oct 2021 - Reuters

New fungus stalks Covid-recovered

After mucormycosis (black fungus), another fungal infection has been detected in four Covid-recovered patients in Pune in the last three months, raising concerns among the health fraternity. Prabhakar* (66) complained of mild fever and severe lower back pain a month after recovering from COVID-19. He was initially treated conservatively with muscle relaxants and non-steroidal anti-inflammatory drugs without relief. An MRI scan revealed severe infection-led bone damage to the spinal disc spaces called spondylodiscitis. A bone biopsy and culture grew aspergillus species — a type of mold (fungus).
15th Oct 2021 - Times of India

90,000 US Covid deaths could have been prevented by vaccines in 4 months, 2 leading nonprofits estimate

About 90,000 Covid-19 deaths in the US between June and September were preventable, two US nonprofits say. In September, 49,000 deaths could have been avoided if more adults got a Covid-19 shot, they said. The Kaiser Family Foundation and the Peterson Center on Healthcare cited a tracker that uses CDC data.
14th Oct 2021 - Business Insider South Africa

Expert panel recommends approving Covaxin for kids

The central drug regulator’s expert panel has recommended granting marketing authorisation with certain conditions to Bharat Biotech's Covaxin for restricted emergency use in children and adolescents in the age group of 2 to 18 years old.
13th Oct 2021 - Times of India


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

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Moderna Booster Shot Backed by FDA Advisory Panel

Vaccine experts advising the Food and Drug Administration voted 19 to 0 Thursday to recommend authorization of an extra dose of Moderna Inc.’s MRNA 3.23% Covid-19 shot, a key step in making booster doses available to millions more people. A vaccine-advisory panel voted in favor of giving a Moderna booster shot at least six months after the second dose, to adults 65 years and older, as well as adults under 65 who are at high risk of severe Covid-19 or serious complications because of their jobs, living conditions or underlying medical conditions.
14th Oct 2021 - The Wall Street Journal

FDA Panel Backs Moderna Booster for Older, High-Risk People

Booster shots of Moderna Inc.’s Covid-19 vaccine should be given to older people and those at high risk of the disease, advisers to U.S. regulators said. Additional doses of the two-shot messenger RNA vaccine should be offered to people 65 and older, along with adults 18 and older who are at high risk for medical or occupational reasons, the Food and Drug Administration’s vaccine advisory panel said Thursday in a unanimous, 19-0 vote. The booster, which is half the original dose, should be given at least six months after the initial inoculation, the panel said. Moderna shares gained as much as 4.9% in Thursday afternoon trading in New York.
14th Oct 2021 - Bloomberg

FDA advisers back Moderna COVID-19 booster shots for older and high-risk people

A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Thursday to recommend booster shots of Moderna's COVID-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus. If the FDA signs off on Moderna's booster, the U.S. Centers for Disease Control and Prevention will make specific recommendations on who should get the shots. CDC advisers are scheduled to meet next week.
14th Oct 2021 - Reuters

FDA vaccine advisers are meeting to consider Moderna Covid-19 vaccine boosters

Vaccine advisers to the US Food and Drug Administration voted unanimously Thursday to recommend emergency use authorization of a booster dose of Moderna's Covid-19 vaccine. The FDA's Vaccines and Related Biological Products Advisory Committee agreed use of a booster dose would be safe and effective in some people six months out from their primary series. But some were clearly reluctant. Moderna had asked for emergency use authorization for a half dose of its vaccine to be used as a booster for certain people.
14th Oct 2021 - CNN

Hungary will receive technology to produce Sputnik V COVID-19 vaccine -foreign minister

Hungary will receive technology this year to produce Russia's Sputnik V COVID-19 vaccine at a Hungarian plant currently under construction, Foreign Minister Peter Szijjarto said in Moscow on Thursday according to a foreign ministry statement. This would be the first concrete step towards making the vaccine in the European Union, even though it is not yet approved in the bloc. The Sputnik V vaccine, widely used in Russia and approved for use in more than 70 countries, is still undergoing a review by the World Health Organization (WHO) and the European Medicines Agency.
14th Oct 2021 - Reuters

J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study

People who got Johnson & Johnson Inc’s COVID-19 vaccine as a first shot had a stronger immune response when boosted with vaccines from Pfizer Inc/BioNTech SE or Moderna Inc, a study run by the National Institutes of Health showed on Wednesday. The study, which is preliminary and hasn't been peer reviewed, is the latest challenge to J&J's efforts to use its COVID-19 vaccine as a booster in the United States. The study, which included more than 450 adults who received initial shots from Pfizer, Moderna, or Johnson & Johnson, showed that "mixing and matching" booster shots of different types is safe in adults. Moderna's and Pfizer's vaccines are based on messenger RNA while J&J's uses viral vector technology.
14th Oct 2021 - Reuters

EU starts real-time review of AstraZeneca COVID-19 antibody cocktail

Europe's drug regulator said on Thursday it had started a real-time review of AstraZeneca's antibody-based COVID-19 therapy, the first protective shot other than vaccines against coronavirus. The decision by the human medicines committee of the European Medicines Agency (EMA) to begin the rolling review was based on early results from clinical studies, the regulator said. It did not say when a conclusion was expected. The move to start a real-time review, so called because data is evaluated as it is made available, came roughly a week after the Anglo-Swedish drugmaker sought emergency approval from U.S. authorities.
14th Oct 2021 - Reuters

COVID-19: New WHO team may be 'last chance' to understand origins of coronavirus

A newly formed World Health Organisation (WHO) team may be "our last chance" to understand the origins of coronavirus, the body's top emergency expert has said. The WHO has named 26 proposed members of its Scientific Advisory Group on the Origins of Novel Pathogens (SAGO), to determine the origins of coronavirus. Maria Van Kerkhove, WHO technical lead on COVID-19, said she hoped there would be further WHO-led international missions to China to encourage the country to cooperate.
14th Oct 2021 - Sky News

What’s the latest advice on the type of mask I should wear?

What’s the latest advice on the type of mask I should wear? It depends on your situation, but health officials say it should cover your nose and mouth, and fit snugly so there aren’t any gaps on the sides of your face. The U.S. Centers for Disease Control and Prevention also says to pick masks with two or more layers and a nose wire to prevent air from leaking out the top. It suggests holding your mask up to check if it blocks light, which means the fabric will probably filter out more particles. If you want added protection, experts also suggest wearing two masks or pairing them with a mask fitter to ensure they don’t leave any gaps.
14th Oct 2021 - Reuters

China warns against ‘manipulation’ of WHO virus probe

China’s Foreign Ministry on Thursday warned against what it called possible “political manipulation” of a renewed probe by the World Health Organization into the origins of the coronavirus, while saying it would support the international body’s efforts. The WHO on Wednesday released a proposed list of 25 experts to advise it on next steps in the search for the virus’ origins after its earlier efforts were attacked for going too easy on China, where the first human cases were detected in late 2019. Beijing was accused of withholding raw data on early cases during a visit by a WHO team in February and has since resisted calls for further investigation, saying the U.S. and others were politicizing the matter.
14th Oct 2021 - The Associated Press

COMMENTARY: What can masks do? Part 1: The science behind COVID-19 protection

Confusion continues to abound over the effectiveness of masks to protect people from COVID-19, and recent news stories touting imperfect studies are only compounding the situation. First, there was confusion and then intransigence about the modes of transmission, with the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) insisting for many months after SARS-CoV-2 emerged that the virus was transmitted only by large droplets or hand contact. Only fairly recently did those agencies finally recognize that inhalation of small infectious particles in the air ("aerosols") is a more important mode of transmission. That was followed by substantial misinformation and misunderstanding about the role of cloth face coverings, surgical masks, and respirators in preventing SARS-CoV-2 spread. Then we had misunderstandings and poor messaging about the efficacy of different interventions, the effectiveness of one intervention versus another, and why interventions should be considered in a particular order or hierarchy.
14th Oct 2021 - CIDRAP

The hidden cost of Covid-19: years of life lost among the young

Body counts appear to support the common perception that Covid-19 does its worst damage among the old and vulnerable. But body counts mask another reality, and focusing on them is skewing policy decisions and individual choices. There’s no question that deaths were most common among old and vulnerable individuals early in the pandemic. Some politicians and academics have used death rates to conclude that the pandemic’s toll has been largely confined to the elderly and sick, and that widespread mitigation measures such as mask and vaccine mandates are unjustified. We looked at Covid-related deaths through a different lens — years of life lost — which revealed a very different picture about the burden of illness than deaths alone.
14th Oct 2021 - CIDRAP

Tracking the FDA advisory panel meeting on Moderna’s Covid vaccine booster

With people who received the Pfizer-BioNTech Covid-19 vaccine already in the process of getting booster shots, attention is shifting this week to what to do with people who received one of the two other vaccines in use in the U.S., the two-dose Moderna vaccine and the one-shot Johnson & Johnson product. Members of the Food and Drug Administration’s vaccine expert panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), are meeting today to discuss Moderna’s application for a booster shot for its product and again Friday to discuss the J&J application. The Biden administration has made it clear that it wants to boost all Americans who have been vaccinated, suggesting they should receive an additional jab six months or later after the last dose in their original vaccine regimen. Though the World Health Organization has asked wealthy countries to hold off on using boosters to make more vaccine available to low-income countries, and some experts have argued most people don’t currently need boosters, the administration has been unswerving on this policy.
14th Oct 2021 - STAT News

WHO says approval for Russia’s Sputnik V vaccine ‘still on hold’

The World Health Organization has said the Emergency Use Listing process for Russia’s Sputnik V COVID-19 vaccine was on hold pending some missing data and legal procedures, which the UN body hopes will be “sorted out quite soon”. “We are working almost on a daily basis with the ministry of health in Russia to address the remaining issues to be fulfilled by the Russian Direct Investment Fund,” Mariangela Simao, WHO assistant director-general for access to medicines and health products, said on Wednesday. Simao said that as soon as an agreement was reached, the WHO will reopen the case and assess data that was submitted, even though it was “still incomplete” and resume manufacturing site inspections in Russia. “All submissions that we have, they are addressed the same way,” she said and did not specify a timeline for when the listing process could be completed.
13th Oct 2021 - AlJazeera

Most COVID-19 survivors have symptoms 6 months on, review finds

A systematic review of 57 studies involving more than 250,000 COVID-19 survivors reveals that 54% still had at least one symptom 6 months or more after initial diagnosis or release from the hospital. In the review, published today in JAMA Network Open, a team led by Hershey (Pennsylvania) Medical Center researchers searched the literature from December 2019 through March 2021 for studies on persistent COVID-19–related symptoms diagnosed using lab results, radiologic findings, or clinical signs or symptoms at or after 1 month.
13th Oct 2021 - CIDRAP

Moderna criticized for COVID-19 vaccine strategy putting once feel-good success story in jeopardy

Since it was approved 10 months ago, the Moderna COVID-19 vaccine has enjoyed a relatively unfettered run on its way to being considered one of the world’s two elite shots. But while COVID vaccine rival and pharmaceutical goliath Pfizer has faced a demanding spotlight, biotech Moderna has skipped along under the radar, avoiding scrutiny and gaining favor as a feel-good, success story. But that’s starting to change. With evidence mounting that other vaccine producers have made their shots more readily available to poorer countries, the shine is wearing off the Boston-based company. And with Tuesday’s revelation to the Associated Press that Moderna has no intention of sharing its mRNA vaccine formula with the rest of the world, the company has taken another public relations hit.
13th Oct 2021 - FiercePharma


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J. & J. Recipients May Be Helped More by Other Brands’ Booster, Study Says

People who received a Johnson & Johnson coronavirus vaccine may be better off with a booster shot from Moderna or Pfizer-BioNTech, according to preliminary data from a federal clinical trial published on Wednesday. That finding, along with a mixed review of Johnson & Johnson’s booster data from the Food and Drug Administration released earlier in the day, could lead to a heated debate about whether and how to offer additional shots to the 15 million Americans who have received the single-dose vaccine. The agency’s panel of vaccine advisers will meet on Friday and vote on whether to recommend that the agency authorize the company’s application for boosters for recipients of its vaccine.
13th Oct 2021 - The New York Times

Covid-19 Vaccine Effects on Death Rates Differ by Country, Why?

It’s one of the great puzzles of the pandemic. Most developed economies are now highly vaccinated with some of the most effective shots on offer, so why are the latest Covid-19 outbreaks more deadly in some places than in others? While it’s clear vaccines led to a drop in fatalities during the most recent delta variant-driven waves compared with earlier bouts with the virus, some countries saw deaths fall to a greater degree than others, an outcome scientists still don’t have answers for. Countries like Germany, Denmark and the U.K. have seen Covid deaths fall to roughly a tenth of previous peaks, according to Bloomberg calculations using data compiled by Johns Hopkins University. In Israel, Greece and the U.S., fatalities fell but remained more than half of the previous peaks.
13th Oct 2021 - Bloomberg

Fifth death in Scotland due to Covid-19 vaccine complications is recorded

A further person has died in Scotland due to underlying adverse effects from the Covid-19 vaccine. The National Records of Scotland has confirmed that the fifth person in the country has now died as a result of complications stemming from receiving the jab. The statistics also show that 4.2 million people had been given the first dose of the vaccine as of September 30. A total of 11,262 have now died from the virus in Scotland, it added. The latest data shows that during the week of October 4-10, 126 registered fatalities included the cause was Covid-19 on their death certificate, a decrease of 17 on the previous week.
13th Oct 2021 - Edinburgh Live

Do COVID vaccines prevent transmission of the virus?

But do vaccines actually limit the spread of the virus? A large study, not yet peer-reviewed, led by a team at Oxford University and looking specifically at the Delta variant has shown that both the Pfizer and AstraZeneca vaccines do indeed reduce transmission of the disease. The study looked at almost 150,000 contacts who were traced from nearly 100,000 initial cases of COVID. The initial COVID-positive cases contained a mix of vaccinated and unvaccinated people and the aim was not only to see which groups were most likely to pass on the virus, but also which of the Pfizer or AstraZeneca vaccines were most effective in reducing transmission.
13th Oct 2021 - Al Jazeera English

BRIEF—Russia recommends RA drug olokizumab for COVID-19 of any severity

The Russian Ministry of Health has issued the 12th version of the Temporary guidelines for the prevention, diagnosis and treatment of COVID-19. This time the expert analysis resulted in a significant expansion of olokizumab usage in clinical practice. Olokizumab is the first in Russia novel genetically engineered biological drug developed by R-Pharm, one of the country’s leading biotechs. In the new document, olokizumab is additionally included in treatment regimens for mild and critical COVID-19 patients in hospital setting.
13th Oct 2021 - The Pharma Letter

Russia to test COVID-19 vaccine in form of nasal spray

Russia will test a nasal spray form of its Sputnik V vaccine against COVID-19 among adult volunteers, according to a state document published on Tuesday, as the country struggles to rein in rising numbers of infections and deaths. read more Russia was quick to develop and launch its Sputnik vaccine when the coronavirus pandemic struck last year, but take-up has been slow, with many Russians citing distrust of the authorities and fear of new medical products. The nasal spray is to be applied in two doses in a clinic in St Petersburg, according to the document published on the state register of medicines, which did not provide the planned timing of the clinical tests.
13th Oct 2021 - Reuters

China to test thousands of Wuhan blood samples in Covid-19 probe

China is preparing to test tens of thousands of blood bank samples from the city of Wuhan as part of a probe into the origins of Covid-19, according to a Chinese official. The move comes amid increasing calls for transparency over the emergence of the virus. The store of up to 200,000 samples, including those from the closing months of 2019 were pinpointed in February this year by the World Health Organization's panel of investigators as a possible source of key information that could help determine when and where the virus first crossed into humans. The samples are kept in the Wuhan Blood Center, and are thought to span 2019, providing real-time tissue samples from a wide swathe of the population in the Chinese city where SARS-CoV-2 is thought to have first infected humans.
13th Oct 2021 - CNN

Panama approves Pfizer COVID-19 booster for high-risk people

Panama has approved a booster dose of Pfizer Inc's (PFE.N) COVID-19 vaccine for high-risk people, including healthcare workers, bedridden patients, nursing home residents and people over 55, health officials said on Tuesday. The Central American country has reported 469,440 COVID-19 infections since the start of the pandemic and 7,275 deaths. More than 5.5 million vaccine doses have been administered since January, covering most of the eligible population. "We have decided to begin the process of applying a booster shot to the population with the Pfizer vaccine, starting tomorrow in public and private hospitals," Health Minister Luis Sucre said.
13th Oct 2021 - Reuters

FDA says Moderna does not meet all criteria for Covid-19 boosters

Scientists at the US Food and Drug Administration said that Moderna has not met all of the agency’s criteria to support use of booster doses of its Covid-19 vaccine, possibly because the efficacy of the shot’s first two doses has remained strong. FDA staff said in documents that data for Moderna’s vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high. The documents were released on Tuesday ahead of a meeting later this week of the FDA’s outside expert advisers to discuss booster doses of the vaccine.
13th Oct 2021 - The Independent

Watch: Merck’s Covid pill could transform treatment. Here’s how it works

Earlier this month, study results showed that molnupiravir, Merck’s investigational antiviral pill, cut hospitalization rates of Covid-19 patients by about half. Molnupiravir is the first oral treatment that has shown promise in treating Covid-19. Another antiviral, remdesivir, can only be administered intravenously. “Having an oral option will be a big change,” said Benjamin Gewurz, associate director of the Ph.D. program in virology at Harvard Medical School. “Some people could just take a pill rather than having an IV or injection of some sort. And that’s what would be a huge, huge advance.”
13th Oct 2021 - Stat News

WHO advisers recommend 3rd COVID vaccine dose for highest-risk groups

The group, called the Strategic Advisory Group of Experts (SAGE), said people in the immunocompromised groups should be offered an additional dose in the vaccine series, since they are less likely to respond adequately to vaccination with the standard series and are at high risk for severe disease. WHO leaders have previously urged countries to postpone broader use of booster doses to free up more vaccine for countries that had much less access to supplies. SAGE said its third-dose recommendation applies to all vaccines that the WHO has approved for emergency use. They include Pfizer-BioNTech, AstraZeneca-Oxford, Johnson & Johnson, Moderna, Sinopharm, and Sinovac. For Sinopharm and Sinovac, two inactivated vaccines from China, SAGE said a third dose should be offered to people ages 60 and older as part of an extended primary series. It added that a third dose of a different vaccine could be considered, based on vaccine supply and access. However, SAGE urged countries to prioritize 2-dose coverage in that age group, then administer third doses, starting with the oldest age groups.
12th Oct 2021 - CIDRAP

FDA scientists neutral on Moderna Covid-19 vaccine booster ahead of key meeting

Food and Drug Administration scientists did not take a clear position as to whether the agency should authorize booster doses of the Moderna Covid-19 vaccine in documents released Tuesday. Posted ahead of a two-day meeting convened by the FDA on booster shots of both the Moderna and Johnson & Johnson vaccines, the documents laid out the case for authorizing Moderna’s proposed booster — a half dose of the existing vaccine — but also noted that data so far make it unclear that the third dose is needed. “Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not,” FDA scientists wrote in a briefing document. However, they wrote, current data suggest that Covid vaccines that are available in the U.S. still protect against severe Covid-19 disease and death.
12th Oct 2021 - STAT News


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

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FDA Staff Don’t Take Position on Moderna Covid-19 Booster

Food and Drug Administration staffers didn’t take a firm stance on Moderna Inc.’s application for a booster dose, indicating there may not be sufficient data to support the extra dose. FDA staff, after reviewing a drugmaker’s application, often weigh whether it should be given a go-ahead. But they also didn’t take a position on Pfizer Inc.’s booster request, later granted. FDA staff reviews are part of the normal process before the agency makes a decision whether to clear a product. In documents made public Tuesday, FDA staff simply restated Moderna’s request and analyzed Moderna’s study data. The extra dose of Moderna’s vaccine appeared to be safe and work well, but the staff said its benefit would depend on how much the protection from the primary series has waned.
12th Oct 2021 - The Wall Street Journal

Moderna Argues to FDA for Half-Dose of Vaccine as Booster

In documents released Tuesday morning, Moderna argued that the Food and Drug Administration should authorize a half-dose of its coronavirus vaccine as a booster shot for recipients at least six months after the second dose, citing evidence that the vaccine’s potency against infection wanes over time. The agency noted in its own analysis that, overall, available data show Moderna and the other vaccines “still afford protection against severe Covid-19 disease and death in the United States.” Moderna cited the rate of breakthrough infections, “real world evidence of reduced effectiveness against the Delta variant,” and falling levels of neutralizing antibodies from its vaccine six to eight months after a second dose. The company said its clinical trial studies showed that a third injection boosted antibody levels — one measure of the immune system’s response — higher than what they had been before the second dose.
12th Oct 2021 - The New York Times

Rapid Covid Tests Can Beat Pandemic: Harvard's Michael Mina

The 37-year-old epidemiologist, immunologist, and physician says it didn’t have to be this way: Workplaces, schools, event spaces, and more that have been desolate for better than a year could have stayed open—and safely—with a technology that’s been here all along. Mina has been an early and tireless champion of inexpensive, do-it-yourself SARS-CoV-2 antigen tests that can return a positive or negative result in about 15 minutes, arguing for their wider deployment in op-ed articles, on Twitter, and in conversations with health authorities.
12th Oct 2021 - Bloomberg

CureVac drops COVID-19 vaccine, pins hope on next-generation shots

CureVac NV said on Tuesday it will give up on its first-generation COVID-19 vaccine candidate and instead focus on collaborating with GSK to develop improved mRNA vaccine technology. The German biotechnology company's shares were off about 8% after earlier plunging as much as 13%, hitting their lowest since going public in August last year. CureVac said it would abandon its application for approval from the European Medicines Agency for its first COVID-19 vaccine candidate, CVnCoV, after late-stage trials delivered disappointing results in June with 47% efficacy.
12th Oct 2021 - Reuters

Moderna, J&J push for COVID-19 vaccine boosters ahead of FDA meeting

Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong. FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.
12th Oct 2021 - Reuters

Covid study linking vaccines to rare side effect of myocarditis was wrong, researchers admit

A research study that linked a very rare side effect to the Covid-19 mRNA vaccines has been withdrawn by researchers after they made a major mathematical error. The Canadian study attracted headlines after it suggested there was a 1 in 1,000 risk of people developing myocarditis or inflammation of the heart after receiving the Moderna or Pfizer/BioNTech vaccines. But the paper’s conclusions were wrong, and the calculation flawed. The numbers used by the researchers, from the Ottawa Heart Institute, underestimated the amount of vaccines delivered in Ottawa over a two-month period with the result being 25 times smaller than the true figure. They had initially based their estimate on a total of 32,379 vaccines doses and 32 cases of myocarditis, when in reality more than 854,000 doses had been given between June 1 to July 31. The study’s findings have been used by anti-vaccination websites and social media accounts in Britain, the United States and Canada.
12th Oct 2021 - The Independent

AZ’s long-acting antibody combo shows benefit in COVID-19 trial

AstraZeneca has announced positive results from a Phase III trial evaluating its long-acting antibody (LAAB) combination AZD7442 in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. In the Phase III TACKLE trial, a total of 90% of participants enrolled were from populations with a high-risk of progressing to severe COVID-19, including individuals with co-morbidities. The late-stage trial hit its primary endpoint, with AZD7442 600 mg given by intramuscular injections (IM) reducing the risk of developing severe COVID-19 or death from any cause by 50% compared to placebo in outpatients who had been symptomatic for seven days or less.
12th Oct 2021 - PharmaTimes

AstraZeneca's long-acting antibody combination treats and prevents COVID-19

Positive high-level results from the TACKLE Phase III COVID-19 treatment trial have shown that AstraZeneca’s AZD7442, a long-acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. On 5 October 2021, the company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19. A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.
12th Oct 2021 - Pharmafield

Merck aims to double supply of Covid-19 antiviral pill on rising demand

Merck plans to double manufacturing capacity for its antiviral pill to treat Covid-19 next year as governments scramble to procure a treatment that a late-stage trial showed cuts hospital admission and death rates in half. The mounting demand for Merck’s drug, the first oral treatment shown to prevent severe disease in vulnerable people with coronavirus, is a sign that it could trigger the same kind of worldwide rush faced by makers of early Covid-19 vaccines. Merck, which this week asked US regulators to authorise use of the drug called molnupiravir, told the Financial Times it had secured deals with Singapore, New Zealand, Australia and South Korea to supply doses in the past week and is in talks with several other governments.
12th Oct 2021 - Financial Times

A primer on what we know about mixing and matching Covid vaccines

Later this week an expert committee that advises the Centers for Disease Control and Prevention will hear about the results of a clinical trial that could influence how Covid vaccines are used in this country at some point in the future. The trial, conducted by the National Institute of Allergy and Infectious Diseases, is a so-called mix-and-match trial, testing the Covid vaccines authorized in the U.S. in combinations with each other. The goal of the trial was to see whether using a different vaccine as a booster shot improves protection. So does getting a dose of Pfizer vaccine after getting a single dose of Johnson & Johnson’s vaccine trigger production of more antibodies than a second dose of the J&J would? Are the messenger RNA vaccines made by Pfizer and Moderna virtually interchangeable, or does switching even there produce a broader set of immune responses?
12th Oct 2021 - Stat News

COVID infects all ages in family equally, but immunity plays a role

Two new studies explore the risk of SARS-CoV-2 transmission among household members, one finding that children and adults are at similar risk and one showing that COVID-19–naïve family members' risk was 45% to 97% lower, depending on the number of members immune through infection or full vaccination.
11th Oct 2021 - Scientific Viewpoint


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French study of over 22m people finds vaccines cut severe Covid risk by 90%

Vaccination reduces the risk of dying or being hospitalised with Covid-19 by 90%, a French study of 22.6 million people over the age of 50 has found. The research published on Monday also found that vaccines appear to protect against the worst effects of the most prevalent virus strain, the Delta variant. “This means that those who are vaccinated are nine times less at risk of being hospitalised or dying from Covid-19 than those who have not been vaccinated,” the epidemiologist Mahmoud Zureik, who oversaw the research, told Agence France-Presse. The study – the largest of its kind so far – was carried out by Epi-Phare a scientific group set up by France’s health system, its national health insurance fund, l’Assurance Maladie (CNAM), and the country’s ANSM medicines agency.
11th Oct 2021 - The Guardian

AstraZeneca antibody cocktail trials show it can halve risk of severe disease, prevent, treat Covid

AstraZeneca's antibody drug cut the risk of severe Covid-19 by at least 50% in a late stage study, the company announced on Monday. The injection, called AZD7442, contains two different antibodies developed from the the blood of people who previously contracted Covid-19. It's the drug first of its kind shown to both prevent and treat Covid-19 in late-stage trials, the company said in a press release. The company has already requested Food and Drug Administration (FDA) approval to use AZD7442 to prevent Covid-19, after late-stage trial results in August showed it reduced the risk of Covid-19 with symptoms by 77%.
11th Oct 2021 - Business Insider

Monoclonal antibody from AstraZeneca lowers risk for serious COVID-19, company says

An experimental drug developed by AstraZeneca reduces the risk for serious illness or death from COVID-19, company officials announced Monday. The drug, a combination of two monoclonal antibodies called AZD7442, lowers the risk of severe COVID-19 or death by 50% in people who have had symptoms for seven days or less, data from a clinical trial showed. Monoclonal antibodies are lab-created proteins modeled on those produced by the immune system to fight off infections. AZD7442 is delivered via injection and both prevents serious illness and treats its symptoms, the company said..
11th Oct 2021 - UPI.com

WHO experts back booster jabs for people with weak immune systems

The World Health Organization (WHO) on Monday recommended that immunocompromised people be given an additional dose of Covid-19 vaccine, due to their higher risk of breakthrough infections after standard immunisation. The Strategic Advisory Group of Experts on immunisation said the additional dose should be offered “as part of an extended primary series since these individuals are less likely to respond adequately to vaccination following a standard primary vaccine series and are at high risk of severe Covid-19 disease”. WHO vaccine director Kate O’Brien, referring to people with lower immunity due to other conditions, told a news briefing: “The recommendation is for a third vaccination, an additional vaccination in the primary series and again that is based on the evidence showing that the immunogenicity and evidence on breakthrough infections is highly disproportionately represented by those people.”
11th Oct 2021 - South China Morning Post

New Clues Emerge About Whether Vaccines Can Help Fight Long Covid

Millions of people suffer from symptoms of long Covid, doctors estimate. Now, early research is offering some clues about whether vaccinations might help. When the vaccines first came out, some people who had suffered from debilitating symptoms for months after their initial Covid-19 infections told their doctors they felt better after getting vaccinated. The response intrigued scientists. Now, emerging research suggests that vaccines may help reduce symptoms in some people. Other recent research indicates that vaccination can reduce the likelihood of developing long-term Covid-19 symptoms in the first place.
11th Oct 2021 - The Wall Street Journal

Merck Asks F.D.A. for Emergency Approval of Covid Pill

Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid. Clearance for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used. The Biden administration is preparing for an authorization that could come within weeks; the pill would likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors’ practices, senior administration officials said.
11th Oct 2021 - The New York Times

Merck Covid-19 Pill: Emergency Use Authorization Sought for Molnupiravir

Merck & Co. and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the U.S. for molnupiravir, moving the pill closer to becoming the first oral antiviral treatment for Covid-19. An application was submitted with the Food and Drug Administration for molnupiravir to treat mild-to-moderate Covid-19 in adults at risk of developing a severe illness that may require hospitalization, the companies said in a statement Monday. Submissions to regulatory authorities worldwide are expected in the coming months after an interim analysis of clinical trial data found it cut the risk of hospitalization for such patients by half.
11th Oct 2021 - Bloomberg

Merck seeks first U.S. authorization for COVID-19 pill

Merck & Co Inc said on Monday it has applied for U.S. emergency use authorization for its drug to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease. An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home. The treatment, molnupiravir, cut the rate of hospitalization and death by 50% in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease, according to data released earlier this month.
11th Oct 2021 - Reuters

COVID-19 vaccine trial participants to be offered additional doses

The government has announced the COVID-19 vaccine clinical trial participants in England will be offered additional approved vaccine for international travel to countries which currently only accept vaccination records with approved for deployment COVID-19 jabs. Although the UK recognises those who are in COVID-19 vaccine trials as fully vaccinated for the purpose of certification, most other countries do not currently recognise clinical trial volunteers who have not had a vaccine that is approved for deployment. As such, the government will now offer these volunteers two additional doses of an approved vaccine, allowing them to gain the necessary certification status to travel abroad with more ease.
11th Oct 2021 - PharmaTimes

Brii Biosciences files EUA with US FDA for Covid-19 combination therapy

Brii Biosciences has filled an emergency use authorization (EUA) application with the US Food and Drug Administration (FDA) for its combination therapy, BRII-196/BRII-198, to treat Covid-19 patients. BRII-196/BRII-198 is a SARS-CoV-2 neutralising monoclonal antibody combination therapy, which is intended to treat non-hospitalised Covid-19 patients at high risk of clinical progression to severe disease. The EUA submission is based on the positive Phase III results obtained from the ACTIV-2 clinical trial that was announced in August.
11th Oct 2021 - Pharmaceutical Technology

INOVIO Gets Approval To Conduct Phase 3 Trial Of COVID-19 DNA Vaccine Candidate,INO-4800 In Colombia

INOVIO said Monday that it has received authorization from Colombia's INVIMA to conduct the phase 3 segment of the company's global Phase 2/3 trial, INNOVATE in Colombia, for INO-4800, its DNA vaccine candidate for COVID-19. The company noted that it is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries in Latin America, Asia, and Africa.
11th Oct 2021 - Business Insider

Merck seeks first U.S. authorization for COVID-19 tablet

Merck & Co Inc said on Monday it has applied for U.S. emergency use authorization for its drug to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease. An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home.
11th Oct 2021 - Reuters

Japan's Chugai files to expand use of COVID-19 antibody drug

Japan's Chugai Pharmaceutical Co said on Monday it has applied to regulators to expand the use of an antibody treatment for COVID-19 to also allow for preventative care. Japanese regulators approved an antibody cocktail known as Ronapreve as a treatment for COVID-19 in July. The latest filing seeks to use the drug as both a prophylaxis for COVID-19 and as treatment of asymptomatic cases, Chugai said in a release.
11th Oct 2021 - Reuters

New antibody treatment ‘both prevents and treats Covid-19’

An antibody treatment developed by pharmaceutical giant AstraZeneca has shown its ability to both prevent and treat Covid-19, according to new data. AstraZeneca submitted a request to the US Food and Drug Administration (FDA) last week for emergency use authorisation for AZD7442, which is made up of two antibodies, as a preventative treatment. In new data released on Monday morning from its Tackle trial, AstraZeneca showed AZD7442 was effective in preventing severe disease in non-hospitalised patients with mild to moderate coronavirus, when compared with a placebo. Most of the 903 people in the trial were at high risk of progression to severe Covid-19, including those with multiple health conditions.
11th Oct 2021 - Evening Standard

Doctors claim Brazil hospitals gave dodgy COVID-19 care

Irene Castilho didn’t even have a day to grieve after her husband died of COVID-19. She was sick, too, coughing and struggling to breathe; he was barely gone when she started using his oxygen mask. The same day, on March 22, she was admitted to a hospital in Sao Paulo. The 71-year-old had followed doctors’ instructions to the letter – dutifully taking her doses of hydroxychloroquine. She also took ivermectin and a battery of anti-inflammatories and vitamins in the so-called “COVID kit” that her health care company, Prevent Senior, mailed to her home. Still, her condition had deteriorated. At the hospital, Castilho received dialysis and was intubated. When physicians consulted Castilho’s daughters about giving her flutamide — a drug typically used for prostate cancer – they declined, worried about possible side effects for their mother who recently had liver cancer.
11th Oct 2021 - The Associated Press

AstraZeneca says drug helps cut risk of severe COVID

Drugmaker AstraZeneca said that its COVID-19 antibodies’ cocktail has helped cut the risk of severe disease or deaths in a late-stage study. The pharma company announced the results on Monday, marking a boost in its effort to develop coronavirus medicines beyond vaccines. The drug, a mix of two antibodies called AZD7442, reduced the risk of severe COVID-19 or death by 50 percent in non-hospitalised patients who have had symptoms for seven days or fewer, meeting the main goal of the study. AstraZeneca’s therapy, delivered via injection, is the first of its kind to show promise as a preventive medicine and as a treatment for COVID-19 following multiple trials. It is designed to protect people who do not have a strong enough immune response to vaccines.
11th Oct 2021 - AlJazeera


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

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7% of Israel’s serious COVID cases had three vaccine shots

Some 7% of Israel’s serious and critical COVID-19 cases were vaccinated with three shots of the coronavirus vaccine, according to data released Friday morning by the Health Ministry. However, the number of new daily cases is declining and the government voted to roll out the Green Class outline in several green cities on Sunday to help keep children out of isolation. “I cannot say that 7% is a lot,” Health Minister Director-General Prof. Nachman Ash told The Jerusalem Post. “The vaccine, even the third shot, does not work at 100%. It is 95% effective.”
9th Oct 2021 - The Jerusalem Post

Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

Moderna, whose coronavirus vaccine appears to be the world’s best defense against Covid-19, has been supplying its shots almost exclusively to wealthy nations, keeping poorer countries waiting and earning billions in profit. After developing a breakthrough vaccine with the financial and scientific support of the U.S. government, Moderna has shipped a greater share of its doses to wealthy countries than any other vaccine manufacturer, according to Airfinity, a data firm that tracks vaccine shipments. About one million doses of Moderna’s vaccine have gone to countries that the World Bank classifies as low income. By contrast, 8.4 million Pfizer doses and about 25 million single-shot Johnson & Johnson doses have gone to those countries.
9th Oct 2021 - The New York Times

Novel vaccine strategy protects mice from COVID-19 and 4 related coronaviruses

The three marketed COVID-19 shots have validated the effectiveness of two vaccination technologies, mRNA and viral vector delivery. But the vaccines—from Pfizer/BioNTech, Moderna and Johnson & Johnson—only protect against SARS-CoV-2, the coronavirus that sparked the pandemic. So a team of researchers in Japan set out to develop a universal coronavirus vaccine in the hopes of preventing future pandemics. Scientists at Osaka University engineered antibodies that prevented SARS-CoV-2 from infecting healthy cells in mice, they reported in the Journal of Experimental Medicine. They were also effective against SARS-CoV-1, which caused a small outbreak in the early 2000s, and three coronaviruses found in pangolins and bats, they said. The experimental vaccination approach exploits the biology of the SARS-CoV-2 spike protein, which shuttles the virus into human cells by binding to a cell surface receptor called ACE2. The spike protein’s receptor-binding domain has a “head” region that facilitates that binding as well as a “core” region. While the head of each type of coronavirus is distinctive, the core regions are virtually identical.
9th Oct 2021 - FierceBiotech

Pregnant women with symptomatic COVID-19 have an increased risk of emergency deliveries

Pregnant women who contract symptomatic cases of COVID-19 are much more likely to suffer emergency complications or have babies who need intensive care, a new study suggests. Researchers from the University of Texas Medical Branch, Galveston, Texas, looked at more than 100 mothers-to-be who were diagnosed with the virus. More than half of pregnant women who developed symptoms had emergency deliveries compared to about four in 10 women without symptoms. Additionally, babies born to symptomatic mothers were more likely to need respiratory support or be admitted to neonatal intensive care units (NICUs).
9th Oct 2021 - Daily Mail on MSN.com

With more Covid-19 booster shots on the horizon, one expert says mixing and matching doses may be an effective approach

Amid the growing prospect of more Covid-19 booster shots becoming available, an expert has suggested that some people could receive a dose of a different vaccine from the one they initially received. "I hope that when the FDA and CDC review data around Moderna and Johnson & Johnson that they will allow a mix-and-match approach," CNN medical analyst Dr. Leana Wen said Friday. Vaccine advisers for the US Food and Drug Administration will meet October 14 and 15 to discuss applications for booster doses from Moderna and J&J's vaccine arm Janssen. And on October 20 and 21, vaccine experts with the US Centers for Disease Control and Prevention are slated to discuss the same course of action.
9th Oct 2021 - CNN

Merck drug less effective against moderate COVID -India regulatory source

Merck & Co's experimental antiviral drug molnupiravir has not shown "significant efficacy" against moderate COVID-19, a source with the Drug Controller General of India said. Aurobindo Pharma Ltd wants to discontinue a late-stage trial of molnupiravir in moderate COVID-19 patients, the regulator's expert committee said on Friday. "There is no significant efficacy against moderate COVID and the effective efficacy is towards mild cases," the source said on condition of anonymity due to the sensitive nature of the discussions.
9th Oct 2021 - Reuters

Iceland Joins Nordic Peers in Halting Moderna Covid Vaccinations

Iceland is joining its Nordic peers in halting inoculations with Moderna Inc.’s Spikevax shot on concern over side effects. The Moderna jab, which has mostly been used in Iceland for second doses, won’t be used until more information over its safety has been collected, the chief epidemiologist said on Friday. Sweden, Denmark and Finland have this week suspended the jabs for younger people because of the risk of heart inflammation as a potential side effect. Norway said men under 30 should consider choosing the Pfizer Inc.’s and BioNTech SE’s rival vaccine, and the other Nordic nations also recommended that as an alternative. Both vaccinations use messenger RNA technology to prompt an immune reaction.
9th Oct 2021 - Bloomberg

Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19

Two Indian drugmakers have requested permission to end late-stage trials of their generic versions of Merck & Co's promising experimental oral antiviral drug molnupiravir to treat moderate COVID-19, a week after Merck said its own trial had succeeded for mild-to-moderate patients. Merck earlier this year suspended its own development of molnupiravir as a treatment for hospitalized COVID-19 patients since many of them have reached a phase of the disease that is too late for an antiviral drug to provide much help.
9th Oct 2021 - Reuters


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Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11

Pfizer and BioNTech said on Thursday morning that they had asked federal regulators to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States. The companies have said they were submitting data supporting the change to the Food and Drug Administration. The agency has promised to move quickly on the request and has tentatively scheduled a meeting on Oct. 26 to consider it. A ruling is expected between Halloween and Thanksgiving. “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against Covid-19,” Pfizer said on Thursday.
7th Oct 2021 - The New York Times

Covid Protection Wanes Months After Second Shot, Studies Show

Immunity provided by the Covid-19 vaccine from partners Pfizer Inc. and BioNTech SE weakens significantly within months, with men having less protection than women, according to research that supports the use of booster doses. Protective antibodies decreased continuously during the six months after the administration of the second dose of the vaccine, according to a study of about 5,000 Israeli health workers, published Wednesday in the New England Journal of Medicine. The levels fell first at a sharp pace and later at a more moderate one. Researchers worldwide are trying to identify the critical threshold of antibodies needed to prevent coronavirus infection, severe illness and death, said Gili Regev-Yochay, one of the authors of the study.
7th Oct 2021 - Bloomberg

Heart Damage Plagues Covid Survivors a Year After Infection, Study Shows

Heart damage from Covid-19 extends well beyond the disease’s initial stages, according to a study that found even people who were never sick enough to need hospitalization are in danger of developing heart failure and deadly blood clots a year later. Heart disease and stroke are already the leading causes of death worldwide. The increased likelihood of lethal heart complications in Covid survivors -- who number in the hundreds of millions globally -- will add to its devastation, according to the study, which is under consideration for publication by a Nature journal. “The aftereffects of Covid-19 are substantial,” said Ziyad Al-Aly, director of the clinical epidemiology center at the Veterans Affairs St. Louis Health Care System in Missouri, who led the research. “Governments and health systems must wake up to the reality that Covid will cast a tall shadow in the form of long Covid, and has devastating consequences. I am concerned that we are not taking this seriously enough.”
7th Oct 2021 - Bloomberg

Germany recommends booster shots for over 70s

Germany's vaccination authority, STIKO, recommended COVID-19 vaccine booster shots for people older than 70 on Thursday. All residents of care homes, as well as workers who come into direct contact with them, should also be offered a third vaccine dose, the body said. The same was also recommended for medical workers in direct contact with patients. STIKO gave its recommendation on the grounds that vaccine protection "declines over time, particularly in terms of preventing asymptomatic and mild infections." Previously booster shots had only be recommended in Germany for people with a weakened immune system.
7th Oct 2021 - DW (English)

Pfizer officially asks the FDA to authorize its COVID vaccine for kids aged 5-11

Pfizer and BioNTech are officially asking the Biden administration to authorize the use of their COVID-19 vaccine for children ages 5 to 11. Pfizer tweeted on Thursday that the companies had submitted their formal request for Emergency Use Authorization of the vaccine to the Food and Drug Administration. "With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," the pharmaceutical giant said.
7th Oct 2021 - NPR

Long Covid officially defined for first time - with three top symptoms listed

Long Covid has finally been given its own definition by the World Health Organisation as more than a million in the UK are said to be battling the condition. The condition has remained one of the most mysterious aspects of the virus as the list of symptoms continued to baffle medics. The WHO has sought to come up with clinical analysis of the symptoms as it formally says Long Covid is a "post-Covid condition". Common symptoms officially include fatigue, shortness of breath, cognitive dysfunction
7th Oct 2021 - The Mirror

Pfizer vaccine for children may be ready by Thanksgiving -White House adviser

Pfizer Inc's new vaccine for children aged five to 11 could be ready as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on Thursday. The Food and Drug Administration has scheduled time to review the Pfizer/BionNTech application for emergency use with its advisory panel at the end of October, to be followed by recommendations from the Centers for Disease Control and Prevention, Zients told CNN.
7th Oct 2021 - Reuters

Pfizer, BioNTech ask U.S. regulators to OK COVID-19 vaccine for kids

Pfizer Inc and BioNTech said on Thursday they had asked U.S. regulators to approve emergency use of their COVID-19 vaccine for children aged from five to 11, Pfizer said in a post on Twitter.
7th Oct 2021 - Reuters on MSN.com

Covid vaccination on top of past coronavirus infection 'gives greater protection'

Previous Covid-19 infection gives double jabbed people greater protection, new research suggests. According to the Zoe study, past Covid infection together with being fully vaccinated increases an individual’s protection against the virus to as much as 94%.
7th Oct 2021 - The Scotsman

Pfizer study to vaccinate whole Brazilian town against COVID-19

Pfizer Inc will study the effectiveness of its vaccine against COVID-19 by inoculating the entire population over the age of 12 in a town in southern Brazil, the company said on Wednesday. The study will be conducted in Toledo, population 143,000, in the west of Parana state, together with Brazil's National Vaccination Program, local health authorities, a hospital and a federal university. Pfizer, which developed the vaccine with German partner BioNTech SE , said the purpose was to study transmission of the coronavirus in a "real-life scenario" after the population has been vaccinated.
7th Oct 2021 - Reuters

Long COVID: More than one million people report ongoing coronavirus symptoms, ONS data shows

More than one million people living in the UK are experiencing the after-effects of COVID-19 following infection, according to the Office for National Statistics. It is the largest monthly increase - up from 970,000 in the previous ONS survey - with 1.1 million people in private households reporting having long COVID during the four weeks to 5 September. Long COVID is defined as symptoms which last for more than four weeks after individuals first suspect they are infected, and are not explained by something else.
7th Oct 2021 - Sky News

Seven people may have brought Covid-19 into NI, experts say

Seven people who were exposed to Covid-19 but had neither symptoms nor were infectious may have brought the virus into Northern Ireland on 1 March 2020. Researchers at Queen's University Belfast suggest it took about 9.6 days for someone exposed to Covid to develop symptoms and become infectious. They said a symptomatic patient could spread the disease for nine days. Experts from the school of mathematics and physics used modelling to reach their conclusions. Dr Gabor Kiss, who led the research, said the number seven was significant because while this seems a small number, the consequences demonstrate "just how infectious Covid-19 is".
7th Oct 2021 - BBC News

Pfizer asks US to allow COVID shots for kids ages 5 to 11

Parents tired of worrying about classroom outbreaks and sick of telling their elementary school-age children no to sleepovers and family gatherings felt a wave of relief Thursday when Pfizer asked the U.S. government to authorize its COVID-19 vaccine for youngsters ages 5 to 11. If regulators give the go-ahead, reduced-dose kids’ shots could begin within a matter of weeks. That could bring many families a step closer to being done with remote learning, virus scares and repeated school shutdowns and quarantines.
7th Oct 2021 - The Associated Press

Merck's molnupiravir will be a blockbuster drug during pandemic. What about endemic COVID-19?

After showing a 50% reduction in the risk of hospitalization or death, Merck & Co.’s molnupiravir looks on track to secure an FDA emergency use authorization and become a blockbuster earner during the pandemic. But what kind of longer-term market will the drug face once COVID-19 makes the likely shift from pandemic to endemic? After showing a 50% reduction in the risk of hospitalization or death, Merck & Co.’s molnupiravir looks on track to secure an FDA emergency use authorization and become a blockbuster earner during the pandemic. But what kind of longer-term market will the drug face once COVID-19 makes the likely shift from pandemic to endemic?
7th Oct 2021 - FiercePharma

Flu shots and Moderna's COVID-19 booster can be given during the same doctor's visit, Sanofi study finds

With the arrival of autumn and warnings of a potential “twindemic,” many are prioritizing vaccinations with more urgency this year. Thursday, Sanofi provided timely data that show elderly people can take care of their COVID-19 booster and flu inoculation needs in one stop. Interim results from co-administration of Sanofi’s Fluzone high-dose quadrivalent vaccine and a Moderna COVID-19 booster in the same doctor’s visit show that both provide similar immunogenicity responses—in addition to comparable safety and tolerability profiles—to when they are provided individually.
7th Oct 2021 - FiercePharma


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

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Booster shot improves immune response of chemotherapy patients; post-COVID depression helped by widely used drugs

A new study helps quantify the improved protection against COVID-19 achieved with a third booster dose of the vaccine from Pfizer Inc (PFE.N) and BioNTech SE in cancer patients who are undergoing chemotherapy. "Chemotherapy can weaken the ability of cancer patients to fight off infections and to respond appropriately to vaccines," said Deepta Bhattacharya of the University of Arizona College of Medicine, coauthor of the study reported in Nature Medicine. Her team studied 53 patients receiving chemotherapy for solid-tumor cancers who received two shots of the vaccine. Almost all of the subjects had an immune response after vaccination. But "the magnitude of these responses was worse than in people without cancer in almost every metric that we measured," Bhattacharya said. "In all likelihood, this leaves cancer patients more susceptible to infection and COVID-19 than healthy vaccinated people." The researchers were able to bring back 20 of the study participants for a third vaccine dose, to see if immune responses would improve.
7th Oct 2021 - Reuters

FDA Is Reviewing Data on Mixing and Matching Boosters, Fauci Says

A study of adults who received booster doses of different Covid-19 vaccines than their original shots has been completed, Fauci said in an interview on Bloomberg Television’s “Balance of Power with David Westin,” and the data have been presented to the U.S. Food and Drug Administration. The National Institutes of Health study looked at the safety, immunogenicity and efficacy of mixing and matching of the three U.S. authorized vaccines for booster purposes. The vaccine from partners Pfizer Inc. and BioNTech SE has been cleared as a booster for vulnerable people, such as the elderly and immunocompromised. Next up for the FDA and the Centers for Disease Control and Prevention is consideration of boosters from Moderna Inc. and Johnson & Johnson.
6th Oct 2021 - Bloomberg on MSN.com

Sweden Halts Moderna's Covid Vaccine for People Aged 30 or Under

Sweden and Denmark decided to halt vaccinations with Moderna Inc.’s Covid-19 shot for younger people because of potential side effects. The Swedish health authority Wednesday cited new data on the increased risk of heart inflammation as a reason for the pause for those aged 30 and under. Denmark will stop giving the shot to those younger than 18. Moderna shares fell as much as 5.3% in New York trading. “We are monitoring the situation closely and are acting rapidly to ensure that Covid-19 vaccinations are constantly as safe as possible, while also providing protection,” said Anders Tegnell, Sweden’s chief epidemiologist.
6th Oct 2021 - Bloomberg

Italy says mRNA COVID jab effectiveness stable after 7 months, but not for all

Seven months after the second dose, there is no reduction in the efficacy of COVID-19 mRNA vaccines in the general population in Italy, while a slight decline is seen for some specific groups, the National Health Institute (ISS) said on Wednesday. The report led by ISS and the health ministry examined data up to Aug. 29 from more than 29 million people who had received two doses of an mRNA vaccine such as those produced by Pfizer and Moderna. It said that in the general population, effectiveness against infection after seven months remained at 89%, while against hospitalisation and death, this time six months after the second dose, it remained at 96% and 99% respectively.
6th Oct 2021 - Reuters

Sweden pauses use of Moderna COVID vaccine, cites rare side effects

Sweden will pause the use of Moderna's COVID-19 vaccine for people born 1991 and later after reports of possible rare side effects, such as myocarditis, the Swedish health agency said on Wednesday. "The Swedish Public Health Agency has decided to suspend the use of Moderna's vaccine Spikevax, for everyone born 1991 and later, for precautionary reasons," it said in a statement. "The cause is signals of an increased risk of side effects such as myocarditis and pericarditis. However, the risk of being affected is very small," it said.
6th Oct 2021 - Reuters on MSN.com

Scancell Doses First Subject in Coronavirus Vaccine Trial

Scancell Holdings PLC said Tuesday that it has dosed its first subject in its clinical trial for its Scov1 and Scov2 vaccine candidates, which aim to protect against all Covid-19 variants of concern. The biopharmaceutical company said that the first patient was dosed in South Africa as part of the program dubbed Covidity, and the candidate was administered using the PharmJet needle-free injection system. The objectives of the first part of the trial are to assess the safety and immunogenicity of Scov1 and Scov2, which target the original virus and variant viruses respectively, in healthy, non-vaccinated subjects.
6th Oct 2021 - MarketWatch

Merck says deal signed with Singapore on COVID-19 antiviral pill

Merck announced on Wednesday a supply and purchase agreement that will provide Singapore with access to its experimental oral COVID-19 antiviral drug, the latest Asian country to try to snap up supplies. Molnupiravir is designed to introduce errors into the genetic code of the virus and would be the first oral antiviral medication for COVID-19. Merck is seeking approval by the United States Food and Drug Administration for the pill.Singapore's health ministry did not immediately respond to a request for confirmation of the Merck agreement.
6th Oct 2021 - Reuters

Long COVID may affect almost 37% of COVID-19 patients

Individuals with long COVID exhibit lingering symptoms, such as fatigue and brain fog, that persist beyond the typical recovery period of 3–4 weeks after the symptom onset. A recent study assessed the incidence of long COVID symptoms using data extracted from de-identified electronic health records. The study found that more than one in three individuals experienced long COVID symptoms 3–6 months after receiving a COVID-19 diagnosis. The study also reports that women, older adults, and individuals with severe illness during the initial phase of a SARS-CoV-2 infection had an increased likelihood of experiencing long COVID symptoms.
6th Oct 2021 - Medical News Today

Australia's Ellume recalls some COVID-19 test kits over false positives

Australian diagnostic test maker Ellume has recalled some lots of its COVID-19 home test, saying they may show false-positive results due to a recently identified manufacturing issue. The company said of the 427,000 tests that were affected, it had recalled about 195,000 tests as they were unused. "Ellume has investigated the issue, identified the root cause and implemented additional controls," the company told Reuters on Wednesday.
6th Oct 2021 - Reuters

UAE authorises Sputnik Light COVID-19 vaccine -Russia's RDIF

The United Arab Emirates has authorised the Russia-developed one-shot Sputnik Light as both a standalone COVID-19 vaccine and a booster shot, Russia's sovereign fund RDIF said on Wednesday.
6th Oct 2021 - Reuters

Swindon site to produce Covid-19 vaccines, PM says

Doses of the Pfizer Covid-19 vaccine are to be made in Swindon, Prime Minister Boris Johnson has announced. It will be made at the Thermo Fisher Scientific site and production is expected to start in 2022. The firm already makes the vaccine at its facility in Monza, Italy. A statement from Pfizer said that regulatory approval, transfer of technology and on-site development work means production cannot immediately begin. It added: "The support from Thermo Fisher - one of more than 20 contract manufacturers across four continents that are - or will be - helping manufacture the vaccine is an example of our efforts to deliver the vaccine to people around the world as quickly as possible."
6th Oct 2021 - BBC News

Covid-19 reinfection rate remains low, analysis shows

The rate of Covid-19 reinfections “remains low”, according to new analysis. When people do get infected for a second time, the virus is much less likely to cause serious illness, according to the Office for National Statistics (ONS). Reinfections become more likely as time goes on, the analysis suggested. It also highlighted how some people are more likely to be reinfected than others. Kara Steel, senior statistician for the Covid-19 Infection Survey, said: “The analysis shows that the estimated number of Covid-19 reinfections in the UK remains low.
6th Oct 2021 - Evening Standard

Cloth vs N95: Which coronavirus mask should you wear?

Mask wearing has been a hotly debated topic, but most scientists agree that face coverings do help reduce the spread of the coronavirus, though the degree to which they do so depends on the quality of the masks themselves. Because about one in three people who have COVID-19 display no symptoms at all, widespread use of masks remains important. A study which reviewed the evidence on mask wearing found in favour of widespread mask use by infected people as a way to help reduce community transmission, concluding that the available evidence suggests that near-universal adoption of any face covering at all, in combination with complementary public health measures, could successfully reduce the community spread of COVID. Models suggest that public mask wearing is most effective at reducing the spread of the virus when compliance is high.
6th Oct 2021 - AlJazeera


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

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Long Covid Symptoms May Be Caused by Micro Clots, Scientists Say

Some of the symptoms of so-called long-covid, the ailments that can persist for months after a Covid-19 infection, may be caused by inflammatory molecules trapped inside tiny blood clots, a scientist at South Africa’s Stellenbosch University said. High levels of inflammatory molecules were found in micro clots in blood samples from people with long-covid, Resia Pretorius, a researcher at the university, said in a statement on Monday. The molecules contained fibrinogen, a clotting protein, and alpha(2)-antiplasmin, which prevents the breakdown of blood clots, she said. These “might be the cause of some of the lingering symptoms experienced by individuals with long-covid,” the university said in the statement. This “provides further evidence that Covid-19, and now long-covid, have significant cardiovascular and clotting pathologies.”
5th Oct 2021 - Bloomberg

Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, study shows

The effectiveness of the Pfizer Inc/BioNTech SE vaccine in preventing infection by the coronavirus dropped to 47% from 88% six months after the second dose, according to data published on Monday that U.S. health agencies considered when deciding on the need for booster shots. The data, which was published in the Lancet medical journal, had been previously released in August ahead of peer review. The analysis showed that the vaccine's effectiveness in preventing hospitalization and death remained high at 90% for at least six months, even against the highly contagious Delta variant of the coronavirus.
5th Oct 2021 - Reuters

Spain approves COVID booster shot for over 70s

Spain on Tuesday approved administering of third doses of the Pfizer and Moderna vaccines, which are based on the same messenger RNA technology, for people aged 70 or over, the health ministry said. Spain has fully vaccinated around 78% of its population, and authorised the booster shot from six months after people receive their second jab, the ministry said in a statement. The campaign to administer the boosters will begin at the end of October. The country had already authorised booster shots for cancer patients, nursing home residents and other vulnerable groups.
5th Oct 2021 - Reuters

Johnson & Johnson seeks emergency authorization from FDA for coronavirus booster shot

Johnson & Johnson asked the Food and Drug Administration on Tuesday to grant emergency use authorization for a booster dose of its single-shot coronavirus vaccine. The action is part of an effort by Biden administration officials to provide increased protection against covid-19, the disease caused by the coronavirus, which has claimed more than 700,000 lives in the United States. Johnson & Johnson “is asking the FDA to look at our data and agree with us that we have enough data to support a boost” for people 18 and older, said Mathai Mammen, global head of research and development for the Janssen Pharmaceuticals division of Johnson & Johnson.
5th Oct 2021 - The Washington Post

CHMP positive option for Pfizer-BioNTech COVID-19 vaccine in the EU

Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the administration of the Pfizer-BioNTech COVID-19 vaccine as a booster shot six months after the second dose. CHMP, part of the EMA, has approved the use of the booster jab for individuals over the age of 18. Following the CHMP positive opinion, the European Commission (EC) will make a final decision on its update to the vaccine’s current Conditional Marketing Authorisation in the EU. In the clinical trial data provided by Pfizer and BioNTech, the COVID-19 vaccine, Comirnaty, was found to elicit significantly higher neutralising antibody titers against SARS-CoV-2, and protection from both the Beta and Delta variants of the disease.
5th Oct 2021 - PharmaTimes

Merck and Ridgeback Biotherapeutics’ Oral Antiviral COVID-19 Treatment Reduces Risk of Hospitalization or Death by 50%

Merck, known as MSD outside of the United States and Canada, and Ridgeback Therapeutics announced on Oct. 1st, 2021, that their investigational oral antiviral medicine molnupiravir significantly reduced severe outcomes associated with COVID-19. According to a planned interim analysis, molnupiravir reduced the risk of hospitalization or death by 50% in non-hospitalized adult COVID-19 patients with mild-to-moderate symptoms. According to a company press release, 7.3% of patients who received molnupiravir (28/385) were either hospitalized or died through Day 29 of the study. Conversely, 14.1% of patients given placebo (53/377) were either hospitalized or died as a result of COVID-19 through Day 29. Additionally, no patients that were given molnupiravir died, whereas eight of those given the placebo did.
5th Oct 2021 - PharmTech

COVID-19: AstraZeneca requests emergency authoritisation in US or drug that reduces risk of developing coronavirus symptoms by 77%

AstraZeneca has requested US authorisation for emergency use of its new treatment to prevent COVID-19 in people who have a lessened response to vaccines because of a weakened immune system. The drugmaker included data in its filing with the Food and Drug Administration from a late-stage trial showing the jab reduced the risk of people developing any coronavirus symptoms by 77%. The antibody therapy, called AZD7442, could be used to protect people who do not have a strong enough immune response to COVID vaccines, or as a booster for those such as military personnel, AstraZeneca said.
5th Oct 2021 - Sky News

COVID-19: Pfizer-BioNTech vaccine effectiveness wanes to 47% against infection after six months

Two doses of the Pfizer-BioNTech vaccine are 90% effective against COVID-19 hospitalisation for at least six months but only 47% effective against infection after that period, according to a new study. The peer-reviewed analysis of the coronavirus jab, published in The Lancet, also found that reductions in the vaccine's effectiveness against COVID-19 infection was due to this waning over time rather than the Delta variant escaping protection. Researchers analysed the electronic health records of 3,426,957 people who had received the Pfizer-BioNTech vaccine as part of the study, 5.4% of which (184,041) belonged to people who were infected and 6.6% (12,130) of those which were hospitalised.
5th Oct 2021 - Sky News

J&J seeks US clearance for COVID-19 vaccine booster doses

Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans. J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company’s one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators. Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity.
5th Oct 2021 - The Associated Press

EU regulator OKs Pfizer vaccine booster for 18 and older

The European Union’s drug regulator gave its backing Monday to administering booster shots of the Pfizer-BioNTech COVID-19 vaccine for people 18 and older. The European Medicines Agency said the booster doses “may be considered at least 6 months after the second dose for people aged 18 years and older.” The agency’s human medicines committee issued the recommendation after studying data for the Pfizer vaccine that showed a rise in antibody levels following boosters given around 6 months after the second dose in people from 18 to 55 years old. The agency also said it supports giving a third dose of either the Pfizer-BioNTech or the Moderna vaccine to people with severely weakened immune systems at least 28 days after their second shot.
5th Oct 2021 - The Associated Press

Merck's molnupiravir will be 'complementary, but not a competitor' to COVID-19 vaccines: analyst

What do Merck’s eye-opening data, recently released for its antiviral molnupiravir on high-risk COVID-19 patients, mean for manufacturers of vaccines? Analysts from the ODDO BHF financial services group see little impact in the short and intermediate term. Even though inoculation rates are low in most lesser developed countries, ODDO says it’s unlikely that countries will shift away from vaccination campaigns to focus primarily on treating high-risk patients with COVID. This is the case despite trial data showing molnupiravir providing a 50% reduction in the hospitalization rate and a 100% reduction in the death rate among patients within five days of symptomatic illness. “The impact on vaccine manufacturers such as Moderna should be limited,” ODDO wrote in a report to investors. “We believe that molnupiravir can be complementary to the COVID-19 vaccine but not a competitor.”
5th Oct 2021 - FiercePharma

Why U.S. pandemic management has failed: lack of attention to America’s epidemic engines

Few U.S. journalists, politicians, or public health officials expressed any extraordinary concern when reports of a novel respiratory virus began to emerge out of China in late 2019 and early 2020. After all, the U.S. had just ranked number one among 195 countries in the 2019 Global Health Security Index — the first major comparative assessment of national capacity to prevent, detect, and respond to infectious disease outbreaks. Experts believed the wealthiest large nation on earth to be well-prepared to weather whatever might come its way. Now, nearly two years since the first documented cases of Covid-19 appeared in Wuhan, more than 700,000 U.S. residents have been killed by a pandemic during which U.S. public health management has been among the world’s worst. Despite American wealth, monopolization of the global vaccine supply, and unparalleled spending on medical care, SARS-CoV-2 has decimated U.S. communities — especially those of color and lower incomes. Repeated policy failures have paved the way for the virus to rapidly replicate, mutate, and fuel deadly outbreaks not just inside this country but worldwide.
5th Oct 2021 - STAT News

What we know — and don’t know — about Merck’s new Covid-19 pill

The announcement that a pill from Merck and partner Ridgeback Biotherapeutics kept Covid patients out of the hospital made headlines and moved stocks late last week. But as is so often true when data are released by press release, there are still many questions left unanswered. Doctors are excited about the medicine, molnupiravir, because a regimen of pills, even one that involves taking several pills twice a day for five days, should be far easier to deliver to patients than current antiviral Covid-19 treatments, which must be given intravenously. But it’s still unclear how widely this treatment will be used. There will also be debate among financial analysts at investment banks regarding exactly how many billions of dollars in sales the new drug will generate.
4th Oct 2021 - STAT News


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

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EU regulator backs Pfizer vaccine booster for all adults after 6 months

Europe’s drugs regulator on Monday advised that healthy adults can receive a third, booster dose of the BioNTech/Pfizer COVID-19 vaccine six months after the second dose. The European Medicines Agency’s medicines committee said the recommendation was based on data from a study of 18 to 55-year-olds, showing an increase in antibodies after a third shot. Data has shown that immunity wanes with the vaccines currently in use, and appears to wane more quickly with the BioNTech/Pfizer jab. The EMA also said that people with severely weakened immune systems may be given a booster dose of either the BioNTech/Pfizer or Moderna jabs just 28 days after their second dose. While there is no direct evidence linking antibody levels to stronger protection in those with weakened immune systems, “it is expected that the extra dose would increase protection at least in some patients,” the EMA said.
4th Oct 2021 - POLITICO Europe

Covid-19 Treatment News: What Drugs, Medicines Are Available for Coronavirus?

In the battle against the Covid-19 pandemic, vaccines have emerged as the weapon of choice. Prevention of disease is always preferable to treatment, and in this case, vaccines have proven far more