FDA Advisory Committee Considers Authorization For Pfizer's COVID-19 Vaccine
AILSA CHANG, HOST:
A COVID-19 vaccine may soon roll out to millions of Americans. The Food and Drug Administration is considering granting emergency authorization to a vaccine made by Pfizer and BioNTech. A group of independent experts met today to help the FDA make its decision, and NPR's Joe Palca has been listening in on that advisory committee meeting and joins us now.
JOE PALCA, BYLINE: Hey, Ailsa.
CHANG: So how would you characterize the committee's advice today?
PALCA: Well, it's been a long day. And I have to tell you, right at this exact moment, they are starting to have a vote on whether to approve the decision that the FDA has to make about awarding what's called an emergency use authorization to Pfizer. They've been asked to vote on whether or not it should be given to people 16 years of age and older. And that seems to be a sticking point because some people on the committee aren't comfortable with that. But I would say that most of the discussion so far has been positive.
And the thing you have to understand about what's going on today is that if it were a drug, you know, people would be OK, all right, well, maybe it might cause some side effects, but you're sick, and you want to get better. With a vaccine, you're giving it to healthy people, and you don't want to give them something that might, might, might, you know, cause them some problem.
CHANG: Yeah. I mean, that's a totally reasonable concern. So remind us what we do know so far about this vaccine.
PALCA: Well, it has been tested fairly extensively. It's been tested in 40,000 people. Half got the vaccine. Half got the placebo. They got two shots 21 days apart. And the results showed that it was 95% effective in preventing illness. And they also found out that there were side effects. They were not severe, but they were real - headache, chills, feeling lousy, aches and pains. And so this is, you know, something that people would certainly live with if they were confident that it was going to prevent them from dying from a dreadful disease.
CHANG: Sure. Absolutely. So what were some of the questions that the committee members had about the vaccine today?
PALCA: Well, as I mentioned, there's not a lot of data about 16 and 17-year-olds. And so there was a concern about whether it's appropriate to make a decision about whether to offer the vaccine to them. There was also a lot of discussion about whether it's - there's not much advice to give to pregnant women about whether or not to take the vaccine. And there's also the question about this business of the severe allergic reaction that people - two people in the U.K. had after getting the vaccine. That was unexpected. They didn't have anything like that during the course of this study. And so it's something that FDA wants to look at some more.
CHANG: So a lot of stuff that we do know about this vaccine so far comes from this study that you keep referencing, this large - what? - 40,000-person study. And I'm just wondering, what happens to the participants in that study now?
PALCA: Well, that was another big discussion issue. I mean, you've asked people to take a vaccine or a placebo, and now you're going to go back to them if this emergency use is authorized and say, well, we think you should not find out yet whether you get the vaccine or not - I mean, whether you should - we don't want to take this business called blinding away so that - you know, so that they won't know whether they got the vaccine or the placebo because that gives them more information from the study. So there's a question because some people feel, well, if you've got something that works, you ought to give it to people.
And I can tell you right now that the committee did just vote, and they voted in favor of granting the emergency use authorization. It wasn't unanimous, but it was lopsided in favor.
CHANG: And there you go. That is NPR's science correspondent Joe Palca.
Thank you, Joe.
PALCA: You're welcome.
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