The FDA took the unusual step Thursday in opening to the public a routine meeting with an advisory group that’s weighing in on approving the coronavirus vaccine as the agency battles public concerns about its safety as well as political pressure from President Donald Trump to approve it before the Nov. 3 election.
The Vaccines and Related Biological Products Advisory Committee, an outside group of researchers and physicians who are advising the Food and Drug Administration on whether to approve a Covid-19 vaccine, debated the standards needed to ensure a Covid-19 vaccine is safe and effective in a meeting broadcast on YouTube and C-SPAN. Those are key questions among medical experts who worry the U.S. will approve a vaccine before it has been adequately tested.
Officials at the meeting Thursday said the public forum was “critical” to build public trust and confidence in the development of potential vaccines, which are being developed in record time. FDA officials promised that any vaccine would undergo rigorous testing before being distributed to the public.
“Vaccine development can be expedited. However, I want to stress that it cannot, and must not, be rushed,” said Dr. Marion Gruber, director of FDA’s Office of Vaccines Research and Review, adding the agency would not lower its standards.
Trump has pushed the FDA to approve a drug in time to distribute by the Nov. 3 election — a daunting task even his closest advisors have said is near impossible.
“I think we should have it before the election, but frankly the politics gets involved and that’s okay. They want to play their games, it’s going to be right after the election,” Trump said in a video he posted on Twitter on Oct. 7. “The FDA has acted as quickly as they’ve ever acted in history. There’s never been a time, and no president’s ever pushed them like I’ve pushed them either, to be honest.”
The agency is approving drugs “in a matter of weeks” that used to take years, he added.
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Four drugmakers backed by the U.S. are still conducting their late-stage trials, and medical experts don’t expect to see trial data needed for FDA authorization until later this month at the earliest.
Because of the pandemic, U.S. health officials and researchers have been accelerating the development of vaccine candidates by investing in multiple stages of research even though doing so could be for naught if the vaccine ends up not being effective or safe.
The FDA, under pressure from the White House, has faced skepticism from medical experts that the vaccine approval