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FDA Advisory Committee Member On Vote On Pfizer's Coronavirus Vaccine Authorization

AILSA CHANG, HOST:

An FDA advisory panel has voted to recommend emergency authorization for Pfizer's COVID-19 vaccine for patients 16 and older. The Food and Drug Administration typically follows the panel's advice, so it is possible vaccinations could begin within days. Dr. Cody Meissner from Tufts University School of Medicine was part of that panel, and he joins us now.

Welcome.

CODY MEISSNER: Thank you very much. It's a pleasure to be here.

CHANG: Well, it's a pleasure having you. So the specific question before the panel today was, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in people 16 years of age and older? How did you vote on that question?

MEISSNER: That's correct. That was the question, and the question received the majority of votes in favor. I voted...

CHANG: Seventeen.

MEISSNER: Yes. I voted to abstain because I was a little uncomfortable with the inclusion of 16- and 17-year-old adolescents in that request for authorization.

CHANG: Right. Let's talk about that because I know your specialty is pediatric. So what were the concerns you had about recommending emergency use authorization for this vaccine in younger people?

MEISSNER: Well, remember; this is an entirely new vaccine. As people, I think - most people are aware, it's a so-called messenger RNA vaccine. We've never had a vaccine that worked in this same manner. Now, the experience that Pfizer presented today - that is, their data from this trial - was just remarkable. This vaccine has been developed in a very short period of time, less than a year. And the efficacy trials have been conducted in a remarkably short period of time, and they've met the criteria that the FDA listed as necessary for an EUA. So from that standpoint, it's wonderful. There are more than 2,500 people dying during each day. Yesterday there were over 2,500.

CHANG: Yes.

MEISSNER: And there will be probably 50,000 deaths due to COVID-19 in the next year - I'm sorry; the next month.

CHANG: Right.

MEISSNER: So...

CHANG: Yet you still have concerns about this particular vaccine when it comes to younger kids, right?

MEISSNER: Yes. I think the issue is this. We were asked the question, does the benefit outweigh the risk? And for the older-age spectrum, clearly there's great risk. That's where most of the deaths, most of the hospitalizations, most of the ICU admissions are occurring. If you look at children...

CHANG: Yes.

MEISSNER: ...Particularly people under 20 years of age, they are getting infected. No question about it. But they're not getting sick.

CHANG: OK.

MEISSNER: They aren't symptomatic. And...

CHANG: So what would you need to know to feel comfortable about authorizing this vaccine in an emergency use situation for those kids?

MEISSNER: Yes. There were only 163 children who were included in this trial - or 163 adolescents 16 to 17 years old. And there were 44,000 people who were enrolled altogether. So it was a very small number. And about half of those 163 got placebo, and half got the vaccine. So we're talking about 80 16- and 17-year-old...

CHANG: Right.

MEISSNER: ...Children who received the vaccine. They're very unlikely to be hospitalized. They're very unlikely to be sick. And they're...

CHANG: So it sounds like you just needed more data. I'm sorry. We are - out of time. But the does that sum it up - that you just needed more data?

MEISSNER: I mean, it's a very important vaccine, and it's wonderful...

CHANG: OK.

MEISSNER: ...We've got it for older individuals.

CHANG: All right. Dr. Cody Meissner of Tufts University School of Medicine, thank you very much.

MEISSNER: Thank you. Transcript provided by NPR, Copyright NPR.