Who are the nerdy virologists leading the U.S. Covid vaccine race
How is the race for anti Covid vaccines in the US going? The in-depth study of the Politico magazine
As the race for the first coronavirus vaccines is about to make the final curve, a dark but influential group of Food and Drug Administration consultants is emerging as the crucial arbiter.
The team of scientists, academics, doctors, and federal health officials will review data on the safety and efficacy of each coronavirus vaccine candidate, and make a critical recommendation to the FDA on whether to give the green light or shelve.
Even if its decisions are not binding, the group of experts has assumed enormous importance, with its first meeting on the coronavirus next October 22 – writes Politico.
President Donald Trump has repeatedly said an injection could come before election day – and accused the FDA of hindering progress. Meanwhile, the agency is trying to hold the line on new stricter standards to authorize the emergency use of any vaccine, and safety concerns have paused late-stage trials of two of the four candidates for the vaccine.
The political context, and the collapse of public confidence in the vaccine race, could make the first meeting of the Vaccine Advisory Committee one of the most popular in FDA history.
" This is a group of nerdy virologists sitting at the table, " said Paul Offit, a vaccine expert at the University of Pennsylvania who sits on the panel and co-developed the rotavirus injection. “ You don't see many situation comedies about a group of fun-loving virologists and epidemiologists. There will be a reason “.
Nonetheless, the FDA is preparing to have tens of thousands of people tune in to the initial panel meeting. Such meetings typically attract an online audience of just 100-1,500 people, an FDA spokesperson said.
A single vaccine is not expected to be ready for review by October 22. But the advisory group is on standby to discuss the merits of each injection as drug makers file applications for FDA clearance or approval – making the group a major player in the crucial final months of the U.S. vaccine push.
“ We don't work for the government, nor do we work for the industry. We just have to go there and look at the data, ”Offit said.
The 20-member committee is a mix of doctors, statisticians, vaccine and infectious disease experts along with two pharmaceutical company representatives and a consumer representative, in this case a lawyer. A group of five are from the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health, but the rest work outside the government.
While the FDA is not required to follow the advice of its advisory committees, it typically does. Commissioner Stephen Hahn and other agency officials, including vaccines head Peter Marks, have repeatedly pointed to the October 22 vaccine meeting as evidence that the agency is driven by science and data, not politics.
" It is critical that the FDA makes the public aware of our expectations on data requirements in support of safety and efficacy, " he tweeted Thursday with a link to the upcoming meeting, adding that a discussion between external scientific and public health experts will help. the public to understand the vaccine review process.
The most important question on the table – and the topic of recent controversies between the FDA and the White House – is when a vaccine manufacturer can declare their injection safe and effective. Committee members also told POLITICO that they expect to discuss the diversity in volunteer enrollment and the impact that emergency clearance could have on ongoing trials for other injections.
" We want to assure the American people that the process and review for Covid-19 vaccine development will be as open and transparent as possible, " said Marks, director of the Center for Biologics Evaluation and Research, in a statement to POLITICO.
While a specific vaccine is not up for discussion for October 22, the discussion about enrollment, safety follow-up, and the bar for efficacy could have implications for all manufacturers in late stage trials.
Pfizer, considered a pioneering company as it operates through Phase III trials, told POLITICO last week that it does not plan to present the data before the meeting. AstraZeneca and Johnson & Johnson, two other manufacturers in the final stages of trials, have paused studies due to severe side effects in one patient. AstraZeneca, which announced the suspension in September, has not yet resumed its studies in the United States.
Manufacturers have refused to promise to archive within a set amount of time, noting that their speed will be dictated by the data they collect – and unforeseen factors, such as suspending a studio for safety reasons, could slow them down.
The FDA also reinforced its expectations for vaccine manufacturers earlier this month, saying that each must follow at least half of the participants in their Phase III trials for two months before applying for a license to use the vaccine. emergency. The new standards have virtually closed the window to any company that applied before election day, prompting the president to accuse career scientists of hindering progress for political reasons.
An FDA spokesperson said the committee's full list, including possible temporary replacements, will be released 48 hours before the October 22 meeting.
The advisory committee will likely discuss how assigning a vaccine with an emergency clearance could make it harder for other companies to find participants for clinical trials of their injections.
Another hot topic is whether the trials enrolled sufficiently diverse groups of participants. The coronavirus has disproportionately infected, hospitalized and killed black and Latino populations, but the two groups have historically been underrepresented in studies.
(Extract from the foreign press review by Epr )
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/mondo/vaccino-stati-uniti-chi-sono-i-virologi/ on Sat, 17 Oct 2020 07:30:47 +0000.