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FDA Immunization Panel Assesses Moderna's Application For Its COVID-19 Vaccine

AILSA CHANG, HOST:

An independent panel of experts met today to help the Food and Drug Administration decide whether a second COVID-19 vaccine should be made available to the public. Well, after nearly eight hours of discussion, the panel gave the FDA a thumbs up on the vaccine made by the biotech company Moderna. NPR science correspondent Joe Palca listened in all day on the panel's deliberations and joins us now. Hey, Joe.

JOE PALCA, BYLINE: Hey, Ailsa.

CHANG: So (laughter) it feels a little bit like deja vu. I mean, you and I were just talking last week - same thing - meeting of experts weighing in on the vaccine made by Pfizer and BioNTech. Tell us about today's discussion.

PALCA: Yeah, it does all feel very familiar. It's the same panel and the same issue. Should the FDA grant an emergency use authorization to a vaccine? This time it's a vaccine made by Moderna, and it's very similar to the vaccine made by Pfizer and BioNTech. To be precise, the committee was asked to vote on one question. Here's FDA's Doran Fink reading the question.

(SOUNDBITE OF ARCHIVED RECORDING)

DORAN FINK: Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 vaccine outweigh its risks for use in individuals 18 years of age and older?

PALCA: So the difference was - well, there were two differences. One was the word Moderna for Pfizer. Did you catch the other one?

CHANG: Age - 18 years instead of 16.

PALCA: Yes.

CHANG: (Laughter).

PALCA: Bing, bing. Yes, you got it. That's perfect.

CHANG: (Laughter) OK, well, what was the breakdown of the vote today?

PALCA: Yeah, it was 20 to nothing, with one abstention. And the panel did have questions for the Moderna representatives at the meeting. One was whether the vaccine worked as well in people older than 65 as it did in people younger. And some of the data made it seem like, well, maybe not. But Jacqueline Miller, a senior vice president at Moderna, said the numbers in older adults weren't as large. They didn't have as many cases, so there was more variability.

(SOUNDBITE OF ARCHIVED RECORDING)

JACQUELINE MILLER: Our view is actually that the efficacy in the elderly is indeed consistent with the efficacy in the overall population.

PALCA: So as they gather more data, that difference, they expect, will become smaller and it will be shown to be effective in older people as well - or as effective.

CHANG: OK. Well, what about side effects? I mean, did the issue of severe allergic reactions come up? I understand that there have been - what? - two cases now of people who had allergic reactions with the Pfizer vaccine.

PALCA: Yeah, two in this country. Well, David Martin is Moderna vice president for pharmacovigilance, which is the person who watches out for severe side effects. And he says there there were no cases of anaphylaxis immediately following vaccination among the 15,000 people who got the vaccine.

(SOUNDBITE OF ARCHIVED RECORDING)

DAVID MARTIN: It's important to note the participants with a history of anaphylaxis, urticaria or other significant hypersensitivity were not excluded from study 301

PALCA: Now, 301 was this big trial they did. And the reason he brought that up is that they were giving the vaccine to people who had severe reactions to other things, just not the vaccine. So they didn't see any in the vaccine either.

CHANG: OK. So besides severe allergic reaction to the vaccines, were there any other concerns that the panel had to discuss today?

PALCA: Yeah. There's a question about how long the vaccine will work for, whether people will be still able to get infected and pass the disease on even if they don't get sick, and they're worried about people dropping out of studies that are currently still all going on. So it's a question.

CHANG: And what happens next in the process now?

PALCA: Well, the FDA makes a decision about granting this emergency use authorization. For the Pfizer vaccine, the decision was the very next day. And I have to say, I don't think anyone would be terribly surprised if the same thing happened this time.

CHANG: All right. Well, that's NPR's Joe Palca. Thank you, Joe.

PALCA: You're so welcome. Transcript provided by NPR, Copyright NPR.

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