COVID-19 vaccine safety, dueling efficacy standards, and representation of groups from racial and ethnic minorities to children drew focus Thursday at arguably the most watched FDA advisory committee meeting ever.
In less than a year, scientists around the world have rallied against COVID-19 and developed promising vaccines that could stem the pandemic. Concerns remain, however, and, against this backdrop, senior government experts took over Thursday to discuss vaccine safety and efficacy requirements, distribution plans and confidence.
It's up to the Food and Drug Administration to decide whether a COVID-19 vaccine is safe and effective enough for public distribution. Today, the agency convened a group of independent experts to offer advice on the way forward. NPR science correspondent Joe Palca has been listening in on that meeting, and he joins us now to talk about it. Hi, Joe.
JOE PALCA, BYLINE: Hi, Ari.
SHAPIRO: So I understand these committees are usually asked to provide advice about a specific product, but that's not the case with today's meeting. Explain what's happening.
The much-anticipated, nine-hour initial public meeting of FDA’s advisory committee on vaccines broached diversity in clinical trials, when placebo patients should get the real thing and how to counteract sinking public confidence in the government and vaccines.
This was the first of what will be a string of Vaccines and Related Biological Products Advisory Committee meetings, with future ones centered on specific shots.
The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.
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With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization (EUA) to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products.
COVID-19 has swept across the world, overwhelming healthcare systems and raising countless questions about how best to diagnose patients, treat infections, save lives, and contain the pandemic. In short order, researchers have launched randomized trials to uncover pharmacologic interventions that hold the promise of preventing or lessening the severity of the disease. But getting results takes time. And time was a luxury that doctors on the frontlines of the coronavirus fight could ill afford in the early months of the pandemic.
Powerful, illuminating and sobering—that’s the description from a research group summing up its initial listening sessions with front-line workers and minority groups about a vaccine.
Tasked with tapping key audiences to learn their questions and concerns about a COVID-19 vaccine—and determine how the FDA might best respond—the nonprofit Reagan-Udall Foundation for the FDA is currently in listening mode on the project, CEO Susan Winckler said.
As the race for an effective COVID-19 vaccine continues, the public will get inside look at one a crucial part of the Food and Drug Administration's decision-making process: the first meeting of its normally obscure advisory committee.
Never before has much attention been paid this small group of vaccine experts whose job is to advise the FDA on whether a new vaccine should be green lighted.
The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at that meeting.
