SCOTT SIMON, HOST:
It's what so many have been waiting for. The FDA late last night issued its first emergency-use authorization for a COVID-19 vaccine. And just today, Army General Gus Perna, who's leading Operation Warp Speed, announced that distribution of the two-shot vaccine is already underway.
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GUS PERNA: Make no mistake. Distribution has begun. Right now, boxes are being packed and loaded with vaccine, with emphasis on quality control.
SIMON: Containers shipping doses will start to move tomorrow. We'll get to how each state will deal with its allocated vaccines a bit later. But first, we're now joined by NPR science correspondent Joe Palca. Joe, thanks so much for being with us.
JOE PALCA, BYLINE: You're most welcome.
SIMON: It is not approval. It is authorization. Is that different from the way these things are normally done?
PALCA: Yeah, this is a big step. It's not an approval, as you say. It's a special category that was created so that in a pandemic, in a health emergency, products could be made available as soon as it was clear that their known benefits outweighed any known risks. And that's what they concluded in this case.
SIMON: And what information did the FDA draw from to make their decision to authorize?
PALCA: Well, the sponsors, Pfizer and BioNTech, did a study of 44,000 volunteers. Half got two shots of a vaccine. Half got two shots of a placebo. And then they waited to see who got sick with COVID disease. And the people who got sick in the trial were - almost 90%, 95% were in the group that got the placebo. So the suggestion is, of course, that the vaccine was protecting people. There were side effects from the vaccine. People complained about having a sore arm or sometimes feeling lousy like they were sick. But in a way, that's saying yes, your immune system is responding to the vaccine and preparing itself should the real virus ever come along. And these side effects were temporary.
SIMON: What's the best thinking now as to who should get the vaccine, even if it's months away, and who should avoid it?
PALCA: Well, the recommendation is for people older than 16. There was some discussion about whether that was justifiable from the data that was collected so far. But in a press conference this morning, FDA officials were saying, yes, we're confident that 16 is a safe age. I mean, they don't make recommendation about whether pregnant women or women who are breastfeeding should take it because, again, they just don't have a lot of data. There was a question about whether it was prudent not to recommend the vaccine for people who get severe allergic reactions to things because of what happened to a couple people who got the vaccine in the United Kingdom. But Peter Marks, who heads the division of FDA responsible for approving this vaccine, said the agency decided not to do that.
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PETER MARKS: We feel comfortable and that we're telling people that unless they've had a severe allergic reaction or one of its components, they can receive it.
PALCA: They just want to make sure that all the places that give out the vaccine have the medicines you need to take care of a severe reaction, should one occur.
SIMON: And a few more vaccines in the pipeline, right, Joe?
PALCA: That's right. Moderna has a vaccine very much like the Pfizer-BioNTech one, and that could be approved next week - as soon as next week.
SIMON: NPR's Joe Palca, thanks so much for being with us.
PALCA: You're welcome. Transcript provided by NPR, Copyright NPR.
