Coronavirus image courtesy of CDC
An independent panel advising FDA is sharing its perspective on the approval process for COVID-19 vaccine.
Much of the virtual Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is focused on the complexities of the pandemic and regulatory best practices.
The optic of an independent panel of scientists discussing the prospect of safe and effective vaccines for the novel coronavirus marked a turning point for the FDA. For months, the agency has pledged its support to carefully weigh vaccine efficacy data. But concerns that the development COVID-19 vaccines is being rushed have diminished the agency’s authority. A number of states are devising independent safety reviews of vaccine candidates, according to Politico.
The publicly accessible meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is also discussing its proposals for authorizing and licensing vaccines for the novel coronavirus.
The meeting is the first for VRBPAC, with a series of others likely to follow in the coming months. FDA expects tens of thousands of people to attend the panel’s first meeting.
FDA has allotted extra time to the daylong meeting to allow public comments.
The stakes are high for the FDA. With COVID-19 infections rapidly spreading throughout much of the U.S., the agency also must contend with growing public skepticism regarding its vaccine approval process.
Peter Marks, who heads the agency’s Center for Biologics Evaluation and Research, said FDA hopes to improve public confidence by making the VRBPAC meeting public.
FDA has organized similar science advisory committees to VRBPAC since 1979, but it is rare for such meetings to achieve public prominence. Such advisory groups advise on everything from annual flu vaccines to peripheral and central nervous system drugs.
The group, composed of academics and physicians, will advise the FDA on how to approve COVID-19 vaccine candidates. “It’s a group of nerdy virologists sitting around,” Paul Offit, a pediatrician and vaccine expert who sits on the panel, told Politico.
The sole pharma industry representative, Paula Annunziato of Merck, will not vote on VRBPAC’s suggestions.
In recent months, a gulf has opened up between the White House and FDA. President Trump has promised the rapid availability of various COVID-19 treatments, while the regulatory agency has mostly taken a more reserved approach. President Trump, a former vaccine skeptic, has recently embraced vaccines as an effective way to stem outbreaks of measles and, more recently, COVID-19.
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