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Group Of Independent Experts To Advise FDA On Coronavirus Vaccine Approval

ARI SHAPIRO, HOST:

It's up to the Food and Drug Administration to decide whether a COVID-19 vaccine is safe and effective enough for public distribution. Today, the agency convened a group of independent experts to offer advice on the way forward. NPR science correspondent Joe Palca has been listening in on that meeting, and he joins us now to talk about it. Hi, Joe.

JOE PALCA, BYLINE: Hi, Ari.

SHAPIRO: So I understand these committees are usually asked to provide advice about a specific product, but that's not the case with today's meeting. Explain what's happening.

PALCA: Well, yes, there are a lot of things that are different this go-around. And I think probably we all know that the speed at which this COVID-19 vaccine has been developed and tested and brought and possibly brought to market is kind of remarkable. So I think the agency is very keen to say, look, we're doing things appropriately, and we're checking with experts as we always do, and it's not something we're going to do without, you know - without checking with the people to vet what we're doing. And we're not going to let politics get in the way, and this is a way of doing that.

SHAPIRO: So what are some of the issues that the committee was asked to address?

PALCA: Well, a large part of the day is focused on a question about what to do if the Food and Drug Administration offers one of the vaccines in emergency use authorization. I'm sure you've heard about that. It's a way of making something available before it's been formally approved. That's because the EUA requires less data and less proof. But they're trying to say, look, we're still going to be sure it's safe, and we're going to be sure it's effective. And it could be very useful in controlling this public health emergency.

SHAPIRO: And if a vaccine does get this emergency authorization, what happens then to all of the other vaccine studies that are still going on?

PALCA: Well, that's - that turns out to be a really difficult question because under normal circumstances, if something is shown to work, it's then no longer ethically appropriate to give them a placebo because that would be putting them at a risk that other people would say they're not necessarily - they shouldn't be exposed to. But the FDA is saying in this case, well, no, this isn't an approval that we're thinking about giving to the - to one of the vaccine candidates. It's an emergency use authorization. And that means there's still a lot of data that we'd like to get.

But they understand that a lot of people in the trial might say, well, hold on a minute. I'm going to - I might bail out of this because I don't want to be in a trial where I'm getting a placebo and I could get a vaccine that's available. So it's a real conundrum. And I think there's going to - this committee is going to have a lot of advice about what to do to deal with that.

SHAPIRO: There's been so much talk about the need for vaccine testing to include minority populations because this disease so disproportionately affects Black, Latino and other people of color. Did that come up today?

PALCA: Oh, yes. And I would say also that earlier today, Pfizer, which is one of the companies that's closest to having a vaccine ready to be evaluated, said that it had 29% minority enrollment in its studies, and Moderna says it had 37%. So the companies are taking pains to say, yes, we're considering these populations, and we're trying to show them that we're testing our vaccine in their populations.

But the Reagan-Udall Foundation, which is an independent foundation associated with the Food and Drug Administration, has been conducting interviews with people, and they clearly show that there's a lot of concern. Is this vaccine going to work for my community? Are you taking appropriate precautions? Are you going too fast? Is it going to be safe? And so there's a tough hill to climb to get people to take this vaccine, even if the FDA gives it some sort of approval.

SHAPIRO: NPR science correspondent Joe Palca, thanks a lot.

PALCA: You're welcome.

(SOUNDBITE TORTOISE'S "TEN-DAY INTERVAL") Transcript provided by NPR, Copyright NPR.