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.
“Clinical trials are critical” in the battle against the global COVID-19 pandemic, Amy Abernathy, principal deputy commissioner and acting CIO of the U.S. Food and Drug Administration (FDA), told attendees of the Veeva R&D and Quality Summit on Tuesday (October 13).
I’m delighted to be with you today for this important meeting of the Global Coalition for Regulatory Science Research. I only wish that we could be together in person.
I want to thank Bill Slikker and his co-chair of the Scientific Program Committee, Marta Hugas, for their hard work in putting this event together.
The importance of the issues you are addressing here is magnified in the context of the current public health emergency we are dealing with.
