What to expect from the official COVID-19 vaccine committee

The group, mostly doctors and researchers, also includes a member of the public.

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.

With the pandemic still raging and a potential vaccine in sight, Thursday will be the first of many FDA Advisory Committee hearings that will give the public an inside look at the highly technical discussions around benchmarks for safety and effectiveness.

At this point, there isn't enough data for the committee to discuss the specifics of the individual vaccines that have progressed to late-stage trials. But for many, this meeting reflects a reassuring return to normalcy in a breakneck scientific race that has, at times, appeared vulnerable to political influence.

The FDA, for example, only recently clarified that it would require at least two months of safety data, effectively quashing President Donald Trump's desire to see an authorized vaccine before the Nov. 3 election.

"They drew a line," said Paul Offit, a committee member and a professor of pediatrics from the Children's Hospital of Philadelphia. "I thought that was the first example recently of the FDA standing up for itself."

In response to concerns that the Trump administration, leading up to the election, is pushing the FDA to rush the vaccine process, officials including FDA Commissioner Stephen Hahn and National Institute of Allergy and Infectious Diseases Director Anthony Fauci repeatedly have pointed to the panel as a safeguard to ensure decisions are made based on science, not politics.

The Thursday meeting, Offit added, is likely to be a free-ranging scientific discussion about safety and effectiveness parameters. The FDA is facing several crucial questions:

  • What specific criteria will be used to decide whether a COVID-19 vaccine should be given emergency authorization for certain high-risk groups?
  • How will follow-up safety data be collected after that?
  • What processes should be in place to seek final, full approval?
  • Over the next few months, the FDA will be leaning on this committee -- an independent group beholden to prioritizing public health -- for recommendations. And although those recommendations aren't binding, the FDA usually follows them.

    FDA employees don't sit on the committee, which is an independent group of more than a dozen doctors, statisticians and academics with special expertise in vaccines. At least one member is a member of the public -- not a doctor or a scientist -- and there's usually at one representative from the pharmaceutical industry, although they don't typically get a vote.

  • Often, the Committee members are expected to vote on specific questions posed by the FDA. But because Thursday's meeting is more likely to be a "free-ranging discussion," continued Offit, "I would be surprised if this was a vote on anything."

    The Committee members will hear from representatives from various government agencies, including the FDA, National Institutes of Health, the Centers for Disease Control and Prevention, and the Biomedical Advanced Research and Development Authority, commonly called BARDA.

    The Reagan-Udall Foundation, a non-profit group, will present on the pressing problem of vaccine hesitancy in the United States, as many Americans have expressed a growing reluctance to receive a COVID-19 vaccine after it's authorized.

    The latter half of the all-day meeting will be an opportunity for the public to comment, and open discussions among committee members.

    The committee plans to hold individual meetings for each vaccine the FDA intends to authorize, the first of which will be discussions involving Pfizer and Moderna, both of which have said they could be ready to ask for FDA for approval by the end of 2020.

    ABC News' Stephanie Ebbs contribute to this report.

    Over the next few months, the FDA will be leaning on this committee -- an independent group beholden to prioritizing public health -- for recommendations. And although those recommendations aren't binding, the FDA usually follows them.

    FDA employees don't sit on the committee, which is an independent group of more than a dozen doctors, statisticians and academics with special expertise in vaccines. At least one member is a member of the public -- not a doctor or a scientist -- and there's usually at one representative from the pharmaceutical industry, although they don't typically get a vote.

    Often, the Committee members are expected to vote on specific questions posed by the FDA. But because Thursday's meeting is more likely to be a "free-ranging discussion," continued Offit, "I would be surprised if this was a vote on anything."

    The Committee members will hear from representatives from various government agencies, including the FDA, National Institutes of Health, the Centers for Disease Control and Prevention, and the Biomedical Advanced Research and Development Authority, commonly called BARDA.

    The Reagan-Udall Foundation, a non-profit group, will present on the pressing problem of vaccine hesitancy in the United States, as many Americans have expressed a growing reluctance to receive a COVID-19 vaccine after it's authorized.

    The latter half of the all-day meeting will be an opportunity for the public to comment, and open discussions among committee members.

    The committee plans to hold individual meetings for each vaccine the FDA intends to authorize, the first of which will be discussions involving Pfizer and Moderna, both of which have said they could be ready to ask for FDA for approval by the end of 2020.

    ABC News' Stephanie Ebbs contribute to this report.

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