U.S. Moves Closer To A Regulatory Approved COVID-19 Vaccine

Dec 8, 2020
Originally published on December 8, 2020 8:44 am
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DAVID GREENE, HOST:

This morning, people in the U.K. began receiving doses of a new COVID-19 vaccine. So how close are we here in the United States? Well, this morning, we saw one important step. The FDA released materials for a committee of independent experts who will evaluate this vaccine. This is the vaccine made by the pharmaceutical giant Pfizer and the German biotech company BioNTech. And we have NPR's Joe Palca joining us this morning. Good morning, Joe.

JOE PALCA, BYLINE: Good morning, David.

GREENE: OK, so one big question. One of the - these - the reasons for optimism is, as we've been reporting, that this Pfizer vaccine is 95% effective at preventing COVID-19. Do these materials get into that question? Do they back that up?

PALCA: Oh, yes. These are actually the - this is the stuff that the FDA will use - the information that the FDA will use to make a decision about whether to grant this emergency use authorization and allow people to get access to this vaccine. You know, it's interesting because so far, what we've seen from the company has been press releases, one or two pages saying how effective it is. And 95% percent effective is what they've been saying. And this - these documents all back that up completely. I mean, it's a very robust - they like that word, robust, in science. It's a very strong and seemingly very reliable measurement.

GREENE: Well, are there any surprises in here that sort of caught you off guard?

PALCA: Well, not so much off guard. But, you know, one of the things that's kind of interesting is this is a vaccine that's given in two doses. And the results are based - this 95% efficacy is based on the two-dose approach. But the vaccine was - they were able to look at numbers that say, well, how effective is it for just a single dose? - which would be better, in fact, for a public health point of view because you'd have that many more doses that you could hand out. And in that case, it was more than 80% effective. Now, obviously, that's not as good as 90% or 95% effective. But if you're thinking about addressing a public health crisis, 80% successful effective vaccine was - is a pretty good mark. So it's just something to think about. I don't know whether that's going to turn out to be important or not, but that's one of the things that jumped out at me.

GREENE: Oh, interesting. Ideally, the - obviously, you want the two doses but interesting numbers there telling us about that single dose. Well, can you tell me, Joe, I mean, what is this process? We have these materials now. Then we're going to have this committee of outside experts. What is the FDA actually asking of this committee?

PALCA: Well, this is a big decision. I mean, you're talking about giving a vaccine to, you know, arguably 300 million people or more in this country and possibly billions around the globe. Not necessarily - they won't all get this vaccine, but a lot of people. And these are otherwise healthy people that don't have any risk from anything that's related to a vaccine unless they get it. So the idea is, well, let's make sure that this really is safe and really is doing what we need both to protect people and, importantly, to bring this epidemic under control because this is an emergency use authorization, not a license to use it forever. And once the emergency is over, the company will have to get the vaccine licensed officially to be able to use it more broadly.

GREENE: So what will the FDA then do once they get this advice from this committee?

PALCA: Well, the committee will say - will vote whether they think this is worthy of an emergency use authorization. And then the FDA will go back and look at the comments that they received and decide, you know, whether they agree - if the committee says, yes, we approve. But it's really hard to predict because this isn't the way vaccines are usually approved or licensed or allowed to be put out in the market. Norman Baylor is president and CEO of Biologics Consulting and a former director of the FDA's Office of Vaccine Research and Review.

NORMAN BAYLOR: Just let me remind you that this has never been done before, so this is the first time. So there is no norm.

GREENE: Going into new territory. All right. NPR's Joe Palca. Thanks, Joe.

PALCA: You bet. Transcript provided by NPR, Copyright NPR.