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FDA Panel Will Weigh Benefits, Risks Of Pfizer's COVID-19 Vaccine

DAVID GREENE, HOST:

Sad to report, we have now seen the highest daily death toll from COVID-19 so far. Yesterday, more than 3,100 people died in the United States, a stunning number. And that is why today's FDA meeting is so very important. The federal drug administration and experts will be weighing the benefits and risks of Pfizer's COVID-19 vaccine for emergency use here in the United States. This is an important step that could pave the way for approving the vaccine in short order.

NPR science correspondent Richard Harris has been following all of this. Richard, good morning.

RICHARD HARRIS, BYLINE: Good morning, David.

GREENE: So fit this meeting into the context of this whole process of at some point, hopefully soon, getting this vaccine approved.

HARRIS: Right. The Food and Drug Administration has a longstanding practice of using advisory committees like this to weigh in on drug approvals. The idea is to get input largely from academic scientists who have an opportunity to raise questions and to do a quick independent evaluation. On Tuesday, the FDA released its recommendations along with an information packet from Pfizer, and that will be the basis of this daylong discussion. The FDA has built a case that this vaccine should be authorized for emergency use.

GREENE: OK. And that's obviously the hope - that they don't find anything unexpectedly wrong here. So how will this all play out today? What's the approval process?

HARRIS: The meeting is scheduled to run all day, and streaming video is available for anyone who really wants to get into the weeds. It's part of the government's effort to be as transparent as possible about approving this product so people have confidence in the process. Friday, the chair of this advisory committee, Dr. Arnold Monto, was at a meeting where he talked about the process.

(SOUNDBITE OF ARCHIVED RECORDING)

ARNOLD MONTO: It's not being done in a way that is any different than review for regular licensure except for the timeline.

HARRIS: The whole FDA review process has been compressed as much as possible in order to get to a conclusion as quickly as possible.

GREENE: So you and other journalists, obviously, have been reporting on what we know so far about this vaccine. It's looked very promising. What exactly are the experts considering today before they can reach a conclusion?

HARRIS: Well, the panel is mainly supposed to review the two biggest questions - is this vaccine safe, and is it effective? Here's Dr. Monto again speaking last week.

(SOUNDBITE OF ARCHIVED RECORDING)

MONTO: Unless there are surprises, there will not be an issue in terms of efficacy.

HARRIS: The FDA says it's 95% effective across a wide variety of ages, as well as races and gender. The committee will also hear about some related issues, such as about plans for monitoring people long term after they've received the vaccine.

GREENE: So when it comes to safety, we heard about these two people who got the vaccine in Britain, and they had a pretty bad reaction. And Britain is now advising people with severe allergic reactions to hold off on being vaccinated. Is any of that a concern that this advisory committee might really take seriously and which could hold things up here?

HARRIS: Well, they will certainly look into that, I'm sure. You're referring to two medical workers who knew they were at very high risk for an allergic reaction. And, in fact, they managed that OK. Side effects are an important part of this process, though. And from the briefing materials involving tests in about 40,000 volunteers, we know that a majority of people who get this vaccine do have some kind of reaction, ranging from soreness at the injection site to headaches, achy joints and so on. But there was nothing really serious in that. And, you know, that's similar to what people get from other vaccines like the shingles shots.

Now, people with a history of severe allergic reactions, like those people in Britain, were actually excluded from the study because officials know the vaccines can actually trigger those.

GREENE: How quickly could approval happen if all goes well?

HARRIS: Well, it could happen quite quickly. Committees like this usually vote at the end of the day, and the FDA then spends a bit more time mulling its decision. But Norman Baylor, a former FDA vaccine official, say a snap decision isn't impossible. He says here's one scenario if the advisory committee's vote is unanimous.

NORMAN BAYLOR: FDA huddles immediately. They could make a determination rapidly that, yep, this is good to go.

HARRIS: And if there is a rapid decision, the first doses of this vaccine could get into people's arms within days.

GREENE: All right. That's the hope.

NPR science correspondent Richard Harris. Thanks so much.

HARRIS: Sure. Anytime. Transcript provided by NPR, Copyright NPR.