FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine
A milestone in the development of COVID-19 vaccines will take place Thursday when the Food and Drug Administration will ask a panel of experts for advice on how to evaluate the vaccines.
NOEL KING, HOST:
There are several COVID-19 vaccines in development. But before they are approved, they have to be safe. It's the FDA's job to ensure that. Today an FDA advisory panel is meeting for the first time about the coronavirus vaccine. It'll be making recommendations based not on politically motivated timetables, but on data.
Sydney Lupkin covers the pharmaceutical industry for NPR. Good morning, Sydney.
SYDNEY LUPKIN, BYLINE: Good morning.
KING: So what is the deal with this FDA panel? Who's on it? What are they going to be doing?
LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. Most often, these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today's meeting of the committee that looks at vaccines is going to be a little different.
LUPKIN: Like everything else in this pandemic, it's a bit unusual. The big difference is that the committee isn't going to be sifting through data for a specific coronavirus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children's Hospital of Philadelphia.
PAUL OFFIT: How robust should safety data be? How long, for example, after the first or second dose should patients be followed or participants be followed for any possible safety issue?
LUPKIN: They'll be discussing FDA's existing guidance to companies, which includes some of that information. They'll also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA usually heeds the advice of these committees, but it doesn't have to.
KING: So since there's no vaccine to review, I would think that in ordinary times, we would not know about this meeting. It would not be news at all. It's very clear that the FDA wants to make public that this is happening. Why do they want to do that?
LUPKIN: Well, I mean, it gives the American public a window into the process. There's been so much discussion around whether the FDA will put politics ahead of science. So it's important to see what's going on. And the FDA has questions that it wants answers to. Here's Dr. Miles Braun, a former FDA epidemiologist.
MILES BRAUN: There is a level of humility that the FDA is coming to its advisers with. And I think that's a good thing. And if they find out they've missed some important things, they'll address those.
LUPKIN: Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in. Diana Zuckerman is the president of the National Center for Health Research, an advocacy group slated to speak.
DIANA ZUCKERMAN: We've seen the guidance of what they're telling companies they're supposed to be studying. Frankly, they're not very stringent, so we are concerned about them.
LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. She also questions whether the study approach the FDA suggested to manufacturers is long enough to assess vaccine safety.
KING: Hmm. So then how does this meeting set up for next steps in the process of reviewing a vaccine?
LUPKIN: This is the first of several advisory committee meetings expected through the fall and winter. The same committee will meet again to evaluate individual vaccines. Instead of full approval, however, vaccine-makers will be seeking a truncated version called emergency use authorization. Here's Dr. Offit again.
OFFIT: The rules here are a little looser in terms of what you would demand in terms of safety or demand in terms of effectiveness of the vaccine.
LUPKIN: Remember, these vaccines will be given to millions and millions of otherwise healthy people, so making sure they're safe is really important.
KING: And so when do we find out more about the leading vaccines?
LUPKIN: Pfizer and Moderna, the front-runners, are expected to have their data ready as soon as November. So once they submit it to the FDA, the public meetings could happen really quickly.
KING: Sydney Lupkin, NPR's pharmaceuticals correspondent.
LUPKIN: Thank you. Transcript provided by NPR, Copyright NPR.
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