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EU regulator authorizes use of Oxford-AstraZeneca COVID vaccine

Berlin — Regulators authorized AstraZeneca's coronavirus vaccine for use in adults throughout the European Union on Friday, amid criticism the bloc is not moving fast enough to vaccinate its population. The European Medicines Agency (EMA) licensed the vaccine to be used in people 18 and over, though concerns had been raised this week that not enough data exist to prove it works in older people.

, CBS News

Oxford-AstraZeneca vaccine approved for use in UK

The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday amid rising coronavirus cases. The UK has ordered 100 million doses - enough to vaccinate 50 million people. This would cover the entire population when combined with the full order of the Pfizer-BioNTech jab, Health Secretary Matt Hancock said.


UK expected to approve Oxford-AstraZeneca Covid vaccine this week

The coronavirus vaccine being developed by AstraZeneca and the University of Oxford is expected to be approved for use in the U.K. in coming days. The Financial Times reported Sunday that government officials confirmed that the Medicines and Healthcare products Regulatory Agency would imminently approve the vaccine, saying the announcement could come as soon as Tuesday. .


US sees record Covid-19 cases as CDC advisory group votes to recommend Moderna vaccine

Covid-19 continues to ravage the United States, even as a second coronavirus vaccine received a vote of recommendation from a committee at the US Centers for Disease Control and Prevention. The CDC's Advisory Committee on Immunization and Practices (ACIP) voted Saturday to recommend Moderna's vaccine candidate for people 18 and older, following the US Food and Drug Administration's decision a day earlier to authorize the vaccine for emergency use


In historic vote, mRNA vaccines go 2 and 0 as FDA experts unanimously back Moderna's Covid-19 vaccine

Come Saturday, the U.S. will likely have two Covid-19 vaccines. The FDA’s advisory committee on vaccines voted unanimously Thursday — with one abstention — to recommend an emergency use authorization for Moderna’s mRNA-based Covid-19 shot, setting the agency up to likely issue the EUA on Friday. The agency does not have to listen to the committee but usually does.


FDA Analysis Of Moderna COVID-19 Vaccine Finds It Effective And Safe

The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from drugmaker Moderna that supports the authorization of the company's vaccine for emergency use. The FDA's briefing document along with one from Moderna were posted two days before a group of experts will convene to advise the agency on whether to grant the vaccine emergency authorization for use, or EUA, during the pandemic.


FDA grants historic authorization to a Covid-19 vaccine, setting stage for rollout

The Food and Drug Administration on Friday issued an emergency authorization for a Covid-19 vaccine developed by Pfizer and its German partner, BioNTech, a seminal moment in the effort to curb a pandemic that has so far infected an estimated 16 million people and killed nearly 300,000 in the United States. “While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

, STAT News

FDA Panel Votes in Favor of Pfizer, BioNTech COVID-19 Vaccine

The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee has voted in favor of granting Emergency Use Authorization (EUA) to Pfizer and BioNTech’s mRNA-based vaccine BNT162b2 for the prevention of coronavirus disease 2019 (COVID-19). The panel voted 17 to 4 in favor of the vaccine for the prevention of COVID-19 in individuals 16 years of age and older.

, Monthly Prescribing Reference

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

One of the world’s leading vaccine manufacturers has suffered a major setback in its work to produce a Covid-19 vaccine. The problem will push the timeline for deployment of Sanofi Pasteur’s vaccine — if it is approved — from the first half of 2021 into the second half of the year, the company said Friday. The news is not just disappointing for Sanofi and its development partner, GlaxoSmithKline, which is providing an adjuvant used in the vaccine. The companies have contracts with multiple countries, including the United States and Britain, as well as the European Union.

, STAT News

F.D.A. Advisory Panel Gives Green Light to Pfizer Vaccine

Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week.

, New York Times

Pfizer coronavirus vaccine clears an FDA hurdle in U.S. as Britain begins administering doses

The Food and Drug Administration has confirmed the safety and efficacy of Pfizer’s coronavirus vaccine candidate. The review also found evidence that the vaccine — which is given in two doses, three weeks apart — began to protect people after the first dose.  The announcement came hours after Britain started administering the same vaccine, becoming the first Western nation to begin a mass effort to inoculate people against the coronavirus.

, Washington Post

Operation Warp Speed chief predicts coronavirus vaccines for all Americans by June

Over the next six months there will be enough coronavirus vaccine produced to immunize every American, Operation Warp Speed chief Moncef Slaoui is predicting.“Hopefully, by the middle of the year, I hope most Americans will have been immunized,” Slaoui, head of the Trump administration’s vaccine initiative, said at a Post Live event yesterday. “If enough people are immunized, we should have this pandemic under control in the second half of 2021.”

, Washington Post

Moderna to seek FDA emergency use authorization based on further trial results

Moderna released new data Monday morning that strengthens the case for its COVID-19 vaccine. It concludes the vaccine is 94 percent effective – and strongly protects against serious illness. Based on these latest findings, the company plans to submit an application for emergency use authorization to the Food and Drug Administration today.


AstraZeneca’s COVID-19 Vaccine Boasts Strong Results with Up to 90% Efficacy

AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90% ... One dosing regimen was given at a half dose and demonstrated 90% efficacy, followed by a full dose at least one month apart. Another dosing regimen demonstrated 62% efficacy when given two full doses at least one month apart. The combined analysis showed average efficacy of 70%.

, Biospace

Pfizer and BioNTech will seek regulatory clearance of their coronavirus vaccine

Pfizer and its German partner BioNTech announced they plan to file Friday for emergency authorization of their coronavirus vaccine, a landmark moment and a signal that a powerful tool to help control the pandemic could begin to be available by mid- to late December. The filing will move the race to its next, deliberative phase — a weeks-long process in which the Food and Drug Administration scrutinizes the data and determine if the vaccine is safe and effective.

, Washington Post

Four reasons for encouragement based on Pfizer’s Covid-19 vaccine results

The article explains why early indications of success for Pfizer's COVID vaccine is also good news for its competitors, many of which base their development efforts on similar mRNA platforms. One impediment (but not a deal breaker) is the need for a cold chain to protect the fragile mRNA molecules. 

, STAT New

Vaccine Research & Developmeng

A very good tutorial comparing traditional vaccine development, manufacturong, and distribution methods and timelines with an accelerated process without compromising safety or ethical integrity

, Johns Hopkins Coronavirus Resource Center

The Secretive and Essential Work to Find a Vaccine

Sanjay Gupta explores what a DSMB (Data Safety & Monitoring Board) does in getting an inside look at the data from a clinical trial, including ones on vaccines. In a double-blind trial, neither the subjects volunteering for it nor the investigators know who is getting active vaccine or placebo. But the DSMB keeps an eye on safety, adverse events, and even if a vaccine is working so well that a trial should be stopped early.


Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant

A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board  would be convened. Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details. 

, STAT News

Hope for Vaccine Before Election Dims as Regulators Assert Power

Top officials in charge of making sure that a safe and effective Covid-19 vaccine is swiftly delivered to the American people waved caution flags on Tuesday, all but assuring that a shot won’t be widely available by Election Day. The Food and Drug Administration has been working for months to hammer out clear standards for vaccines seeking to be fast-tracked to market. The process has placed the agency at odds with the White House, which has wanted to get a shot approved by the time Americans head to the polls on Nov. 3.

, Bloomberg News

White House cited drug companies’ objections in overruling FDA’s vaccine standards

The White House blocks more rigorous FDA standards for emergency use authorization of a coronavirus vaccine, hoping to achieve a (dubious) political win in getting a vaccine approved before Nov. 3. But will an already skeptical public see it as a win, and will they lose continue to lose confidence in the safety or efficacy of suchg a vaccine? A political win (if that) may really be a public health loss.

, Politico

Covid-19 Vaccine Trials Need Only a Fraction of People to Get Sick

Just 150 or so of the 30,000 or more subjects enrolled in U.S. trials conducted by Pfizer, AstraZeneca, Moderna and Johnson & Johnson need to be infected and show symptoms to provide the data to assess the vaccines, according to a Wall Street Journal review of researchers’ plans.

, Wall Street Journal

Novavax launches Phase III trial of Covid-19 vaccine in UK

The study is designed to recruit up to 10,000 participants aged 18 to 84 years, with and without relevant comorbidities, over the coming four to six weeks. It is intended to involve at least 25% of subjects aged above 65 years, and also prioritise groups most impacted by Covid-19, including racial and ethnic minorities.

, Clinical Trials Arena

Johnson & Johnson's coronavirus vaccine is fourth to begin Phase 3 trials in the United States

Trials for the single-dose vaccine will include up to 60,000 adult participants at nearly 215 sites in the US and internationally.  While the other vaccine candidates require two doses, Johnson & Johnson's candidate will be studied as a single-dose vaccine, which should expedite results Chief Scientific Officer Dr. Paul Stoffels said on a call with reporters.


WSJ NEWS EXCLUSIVE:  CDC Advisory Panel to Delay Vote on Initial Covid-19 Vaccine Roll-Out

The Advisory Committee on Immunization Practices may wait until government authorizes specific vaccine or vaccines before voting on prioritization plan for recipients. The group of external medical experts that advises the Centers for Disease Control and Prevention was initially expected to vote at a meeting Tuesday on a plan to give priority to initial doses of any Covid-19 vaccine that passes muster in clinical trials.

, Wall Street Journal

AstraZeneca Sees Oxford Vaccine Possible by End of Year, Despite Setback

AstraZeneca PLC’s chief executive said a Covid-19 vaccine it is developing with the University of Oxford could still be ready by the end of the year, despite the company pausing late-stage trials after a participant in the U.K. developed an unexplained illness.

, Wall Street Journal

Pfizer's Latest Stealthy Move Could Help It Win the Coronavirus Vaccine Race

With multiple SARS-CoV-2 vaccines in testing, Pfizer may be betting that positioning itself to prevail in the long run will be a better strategy than necessarily being first to market. With multiple vaccine candiates in its portfolio, one may emerge later as more efficacious than what comes first. 

, The Motley Fool

'Mind-bogglingly complex': Here's what we know about how COVID vaccine will be distributed when it's approved

"It's just incredible. I think the vaccine supply chain is one of the most mind-bogglingly complex supply chains ever built." -- Johns Hopkins professor of operations management. It will involve which vaccine(s) to use, production, cold chain, the CDC, middle men, decisions on whom to vaccine first, how/where to administer it, storage, shelf life, injection supplies, PPE, record keeping for a second shot, and more.

, USA Today

WSJ NEWS EXCLUSIVE: Covid-19 Vaccine Developers Prepare Joint Pledge on Safety, Standards

Several drug makers developing Covid-19 vaccines plan to issue a public pledge not to seek government approval until the shots have proven to be safe and effective, an unusual joint move among rivals that comes as they work to address concerns over a rush to mass vaccination. A draft of the joint statement, still being finalized by companies including Pfizer Inc., Johnson & Johnson and Moderna Inc. and reviewed by The Wall Street Journal, commits to making the safety and well-being of vaccinated people the companies’ priority. The vaccine makers would also pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in the manufacturing processes.

, Wall Street Journal

Top Adviser To Operation Warp Speed Calls An October Vaccine 'Extremely Unlikely'

In separate interviews Thursday with NPR, the chief scientific adviser to the Trump administration's vaccine development effort and the former director of the CDC's office of public health preparedness cautioned that an effective vaccine is likely still months away ... “I'm very optimistic about a vaccine and potentially more than one vaccine," Dr. Ali Khan said. But the notion that one may be ready in October was "super optimistic," he said.


AstraZeneca starts 30K-subject U.S. phase 3 COVID-19 vaccine trial

Phase 3 trial in U.S. should show how this population reacts to vaccine. Since the trial primary endpoint is event-driven (sufficient number of infections), completion of the trial depends on the level of viral transmission. 

, Fierce Biotech

Covid-19 Vaccines: What’s Coming and When?

Some 170 Covid-19 vaccines are in development around the world, according to the World Health Organization. Now, a handful are starting or nearing the final stage of testing. Depending on the results, some companies say their vaccines could be greenlighted for use as soon as this year.

, Wall Street Journal

F.D.A. Chief Highlights Circumstances for Early Vaccine Approval

Dr. Stephen M. Hahn, who has been under pressure from the White House to speed coronavirus treatments, said in a newspaper interview that his agency would be willing to approve a coronavirus vaccine before Phase 3 clinical trials were complete if the agency found it “appropriate” to do so.

, New York Times

Plan to expand global access to Covid-19 vaccines nears fish-or-cut-bait moment

The deadline is fast approaching for less wealthy countries to commit to purchasing COVID vaccines through the COVAX facility when available, now that wealthy countries (US, UK, Japan, Canada, Australia, and others) have already signed bilateral contracts with manufacturers to buy millions of doses for themselves.


Moderna Says Covid-19 Vaccine Shows Signs of Working in Older Adults

Moderna Inc. said Wednesday its experimental coronavirus vaccine induced immune responses in people aged 56 years and older that were comparable to those seen in younger adults in a small study, a promising sign for a vulnerable age group. The 20 subjects received the dose level of the Moderna vaccine that has been advanced to a late-stage, Phase 3 study.

, Wall Street Journal

Operation Warp Speed Accelerated Vaccine Process

Infographic: The U.S. Department of Defense, a participant in Operation Warp Speed to develop a vaccine against COVID-19, outlines an ambitious timeline to deliver 300 million doses of a safe and effective vaccine by January 1, 2021.

, U.S. Department of Defense

Novavax coronavirus vaccine candidate begins Phase 2 trials

Novavax on Monday announced it would proceed with Phase 2 clinical trials to determine if its coronavirus vaccine candidate showed positive results for patients. Its move to begin the second phase of study comes just weeks after reporting that its vaccine showed promising signs in early trials. 

, The Hill

COVID-19 vaccine tracker

Candidate vaccines by sponsor, trial phase, institution, & funding as of 13 August (click green "Study Design & Details" box to see those items)

, Regulatory Affairs Professionals Society (RAPS)

Putin says Russia has approved 'world first' Covid-19 vaccine. But questions over its safety remain

READY, FIRE, AIM! Russian vaccine gets approval as phase 3 trials start only this week. "I know that it works quite effectively, it forms a stable immunity." -- Putin. (Is that like "a very stable genius"?) Antibodies are one thing, but poven prevention of disease is the important criterion. Political pressure to rush approval could sully other vaccines if testing goes south.


Johnson & Johnson reaches deal with U.S. for 100 million doses of coronavirus vaccine at more than $1 billion

The company’s experimental vaccine is currently in early-stage human trials and is expected to begin late-stage human trials in September. The deal gives the U.S. the option to order an additional 200 million doses. The U.S. had previously awarded J&J $456 million to develop its vaccine earlier this year. J&J said its goal is to supply more than 1 billion doses globally through 2021


Russia plans mass vaccination campaign in October

Reuters, citing anonymous sources, said Russia's first potential vaccine would be approved by regulators this month.  However, some experts are concerned at Russia's fast-track approach.


US promises $2.1B to Sanofi, GSK in latest coronavirus vaccine deal

Sanofi and GlaxoSmithKline will get up to $2.1 billion from the U.S. government to help test, manufacture, and, potentially deliver their experimental shot.  The companies expect to begin a Phase 1/2 study of their candidate in September, followed quickly by a Phase 3 trial before the end of the year.

, BioPharma Dive

Single-shot COVID-19 vaccine proves successful with primates

A single-shot vaccine for COVID-19 has proven successful in tests on primates and could begin phase 3 trials as early as September. The results of the tests on the vaccine, developed at Beth Israel Deaconess Medical Center in collaboration with Johnson & Johnson, showed that it promoted creation of protective antibodies and built on the team’s previous results. It is published in the journal Nature.

, Harvard Gazette

Vaccines may arrive in record time, but the virus has been faster

Scientists have created candidate vaccines with astonishing speed, compressing scientific efforts that usually take years into months. But the leader of a key drug trial said Tuesday that the blistering research pace has nonetheless been too slow to catch the coronavirus

, Harvard Gazette

FDA Insight: Vaccines for COVID-19, Part 2

Podcast and transcript: FDA's Dr. Peter Marks explains Operation Warp Speed and how it intends to speed up COVID-19 vaccine development without sacrificing assurances of safety and efficacy.

, U.S> Food and Drug Administration

Comment: Next-generation vaccine platforms for COVID-19

An overview of classic vaccine technologies and next-generation vaccine platforms, which will accelerate COVID-19 vaccine development and development of vaccines to future infectious threats.

, Nature Materials

Top COVID-19 vaccine makers say safe, effective and low-cost candidates possible by early 2021

Top vaccine makers predict a vaccine or vaccines may be available as early as the beginning of 2021 and at least two pledged doses will be free or low-cost for all Americans. Speaking before a House subcommittee Tuesday, executives from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer said their goal is to have effective vaccines available as soon as possible while following all safety and regulatory guidelines. 

, USA Today

Decades of research on an HIV vaccine boosts the bid for one against coronavirus

Those decades of research into HIV have taught scientists an enormous amount about the immune system, honed vaccine technologies now being repurposed against the coronavirus and created a worldwide infrastructure of clinical trial networks that can be pivoted from HIV to the pathogen that causes the disease covid-19.

, Washington Post

Coronavirus vaccines latest updates

Of the 21 vaccine candidates listed by the WHO in clinical trial stages, the vaccine candidates by Chinese company Sinovac, China National Pharmaceutical Group (Sinopharm) and Oxford University-AstraZeneca are undergoing Phase III tests ,,,  GlaxoSmithKline (GSK), which is already working with Sanofi on a shot, has partnered with Canadian biopharmaceutical firm Medicago to develop and manufacture a plant-based adjuvanted Covid-19 vaccine candidate.

, The Indian Express

'At War Time Speed', China Leads COVID-19 Vaccine Race

SEOUL/SINGAPORE (Reuters) - China is forging ahead in the race to develop a vaccine to help control the COVID-19 pandemic, with Sinovac Biotech's experimental vaccine set to become the country's second and the world's third to enter final stage testing later this month.

, Reuters

Novavax Announces $1.6 Billion Funding from Operation Warp Speed

Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate, as early as late 2020.

, Novavax press release

Coronavirus Vaccine Enters Human Testing in U.S.

Researchers at the New York University Grossman School of Medicine in Manhattan and the University of Maryland School of Medicine in Baltimore said Tuesday they began injecting people with the first of four vaccine candidates from Pfizer and Germany’s BioNTech.

, Wall Street Journal

How Long Will a Vaccine Really Take?

But if there was any time to fast-track a vaccine, it is now. So Times Opinion asked vaccine experts how we could condense the timeline and get a vaccine in the next few months instead of years.Here’s how we might achieve the impossible.

, New York Times