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. .
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
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.
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.
The FDA today released its internal review of the Pfizer/BioNTech request for emergency use approval of their COVID-19 vaccine. The document reveals that the vaccine met all efficacy and safety milestones set by the agency and strongly suggests the vaccine will be approved by the review committee. Remarkably, no major surprises or concerns were identified. This is unusual for such a large and comprehensive (44,000 people) data set. However, there were a few insights that had not previously been made known. Most make the data, if anything, more compelling.
An industrial and systems engineer explains how a vaccine will get from a manufacturer into your arm: the cold chain, facilities capable of handling it, information systems for tracking product and vaccine recipients, and policy decisions, including equity.
Most vaccine development data will go through Fauci before it reaches the FDA for vaccine approval, except for Pfizer's data. The NIAID will determine if the data is ready for prime time.
Win one for science and rationality: The FDA prevails over White House effort to block FDA guidance on stricter requirements for coronavirus vaccine approval
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.
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.
He who is last may later be first. Expertise in clinical trials, scaling up production on a commercial scale, and distribution of vaccine -- and "substantial muscle memory of doing that" -- may beat first-out-of-the-box.
How did a lead investigator working with one of the major COVID vaccine developers become chair of the FDA's vaccine advisory committee in the first place? Without ascribing any ill intent or motive to her, it just seems very tone deaf. Doesn't the U.S. have enough qualified experts to chair the committee so as not to commit such a blunder?
Bill Gates highlights several missteps in the federal government's reposnse to the COVID-19 pandemic: "You know, this has been a mismanaged situation every step of the way," Gates told STAT News.
With very little information about the one recent serious adverse effect in the AstraZeneca vaccine trial, NIH scientists are circumspect regarding the safey of the vaccine -- not to say that it may not be safe, but they need more information before being assured that the trial should proceed in the U.S.
The IDSA urges the FDA to approve and license any vaccine based on completed phase 3 trials and not through an Emergency Use Authorization. However, if the FDA issues an EUA, the IDSA urges it to use both internal and independent external experts to review full safety and efficacy data.
The emergency-use authorization, expected Sunday, would come after preliminary studies supported the benefits of the antibody-rich plasma taken from recovered Covid-19 patients
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.
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.
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.
The article argues for adherence to existing structures for drug/vaccine development in the quest for a SARS-CoV-2 vaccine. "...consent is not suficient for the justification of additional risk," the author asserts.
“Allergic reactions to vaccines are rare but...not unheard of, and they’re seen for most vaccines,” says Jason Schwartz, an assistant professor of health policy at the Yale School of Public Health and co-chair of the Connecticut COVID-19 Vaccine Advisory Group’s Science Subcommittee. While these events need to be taken seriously and investigated, he says, “I wouldn’t anticipate [them], based on what we know right now, substantially changing or slowing the rollout of these vaccines.”
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.
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.
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.”
CDC director Robert Redfield told "The Daily Briefing" that a vaccine would initially be made available "in a hierarchical way" with priority going to "nursing home residents and then some combination of health care providers and individuals at high risk for a poor outcome."
An industrial and systems engineer explains how a vaccine will get from a manufacturer into your arm: the cold chain, facilities capable of handling it, information systems for tracking product and vaccine recipients, and policy decisions, including equity.
A very good tutorial comparing traditional vaccine development, manufacturong, and distribution methods and timelines with an accelerated process without compromising safety or ethical integrity
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.
The WHO plan is to vaccinate some people in all countries, not everyone in some countries. Funding will come from middle- and upper-income countries. 170 countries will participate in the distribution plan. The U.S is not one of them. A pandemic by definition is a widespread disease, in this case, a global one.
A podcast with editors of NEJM covering how COVID-19 vaccines are being developed, discussing a recent setback of one case of a possibe neurological adverse effect, and then talking about vaccine global deployment -- how and to whom first.
"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.
The Trump administration said it will not join Covax, a global effort to develop, manufacture and equitably distribute a coronavirus vaccine, in part because the World Health Organization is involved, with potential implications for U.S. and global public health as well as the global economy.
Ezekiel Emanuel, MD, PhD, of the University of Pennsylvania's Perelman School of Medicine, Department of Medical Ethics and Health Policy, discusses logistics, policy, & ethis of COVID vaccine distribution (at 15:28-25:58; Recorded August 19, 2020)
Ezekiel Emanuel, chair of Medical Ethics & Health Policy at the University of Pennsylvania, believes a COVID vaccine will need to be given to people who have the highest risk of transmitting the virus, who are not necessarily front-line health care workers.
The HHS said the contract, which includes an option to distribute vaccines in the event of a pandemic, was awarded to McKesson as part of a competitive bidding process in 2016.
Even if the most optimistic projections hold true and a Covid-19 vaccine is cleared for U.S. use in November, the vast majority of Americans won’t be able to get the shots until spring or summer next year at the earliest.
The article focuses on identifying "key ethical, empirical, and methodological gaps, related to COVID-19 vaccine uptake, that require urgent attention by both researchers and funders" -- gaps that it says exist in Operation Warp Speed. "If we build it, they will come" is probably not a valid assumption. Or as Jonathan Mann, former head of the WHO global AIDS program, once said about a potential AIDS vaccine, a vaccine in a bottle on a shelf will do no one any good.
As manufacturers around the world race to develop Covid-19 vaccines, a parallel effort has begun to figure out who in the United States should get them first — and how those doses should be distributed.
[PODCAST] The FDA's Peter Marks, MD, PhD talks with JAMA Editor Howard Bauchner, MD on vaccine progress as of Oct. 5 and prospects for pre-election interference in the FDA approval process.
Two bioethicists explore the ethics, legal aspects, and what knowledge may be gained or lost when scientists self-administer untested products developed as COVID-19 vaccines.
A vaccine approved based on administering it to 76 volunteers? More mainstream vaccine developers are planning phase 3 trials involving ~30,000. But no Russian trial results or protocols for phase 3 trials have been published.
How public health officials may use Youtube videos to increase awareness and interest in COVID-19 vaccine, demonstrate to the public the safety and effectiveness of the vaccine(s), and make informed decisions about vaccine uptake.
Dr. Anthony Fauci says he would "settle" for a Covid-19 vaccine that is 70% to 75% effective, but that this incomplete protection, coupled with the fact that many Americans say they will not get a coronavirus vaccine, makes it "unlikely" that the US will achieve sufficient levels of immunity to quell the outbreak.
Less than half of the population would need to be immune to COVID-19 to develop "herd immunity" to the virus, according to an analysis published Tuesday by the journal Science.The modeling study found that herd immunity potentially could be achieved with about 43 percent of the population being immune, as opposed to the 60 percent estimate derived from previous models.
