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The Food and Drug Administration has made public drugmaker Moderna’s application for emergency authorization of its COVID-19 vaccine. NPR explores what researchers think of the application.
MARY LOUISE KELLY, HOST:
The first COVID-19 vaccine in the U.S. is about to get some company. The biotech firm Moderna has asked the Food and Drug Administration for emergency authorization for its vaccine. The FDA released its analysis of that vaccine today, providing the most detailed look yet at the Moderna vaccine. And the FDA’s conclusions point to a likely authorization later this week. Joining me is NPR science correspondent Joe Palca. He has been getting reaction from researchers. Hey, Joe.
JOE PALCA, BYLINE: Hey, Mary Louise.
KELLY: What kind of reaction are you hearing?
PALCA: Well, the ones I talked to were impressed. Here’s what Stacey Schultz-Cherry had to say. She’s a professor in the department of infectious diseases at St. Jude’s Children’s Research Hospital.
STACEY SCHULTZ-CHERRY: Overall, the safety looks good. The efficacy looks really good in the population they tested. So I’m excited.
PALCA: Moderna tested its vaccine in about 30,000 people. Half got two shots of the vaccine, half a placebo. Overall, protection was better than 94%, although not quite that good in people older than 65.
SCHULTZ-CHERRY: It did go down a little bit, but it still looks really good.
KELLY: Really good – we can hear she is excited. But Joe, what about side effects? I’m remembering people who got the other vaccine, the Pfizer BioNTech vaccine that the FDA authorized last week. They had some complaints about feeling lousy for a day or two afterward.
PALCA: Yeah, that’s definitely the case. And it’s the same for the Moderna vaccine. It’s a little hard to compare. They measure things a little bit differently. But it seemed as if the complaints were a bit louder and more frequent with the Moderna vaccine. But Jesse Goodman – he’s now at Georgetown University Medical Center, but he used to be the chief scientist at FDA. And he says it’s important to maintain perspective.
JESSE GOODMAN: You have to look at those reactions and the sore arm, the muscle aches, joint aches and weigh that and balance it with the fact that, you know, we’re preventing a disease that’s proving fatal for thousands of people every day.
KELLY: All right. Now, doctors keep stressing that if you have mild side effects, that means the vaccine is working. It’s in there. It’s doing its job. Joe, bring us back to Earth a little bit. If the FDA grants emergency authorization to this Moderna vaccine, we are not out of the woods yet.
PALCA: No, that’s the case. We are not out of the woods yet. For one thing, there’s not enough vaccine to go around. But think about it. The virus is not going away. I mean, even – it’s going to be around for several months to come and not just in this country. You have to realize this is a global problem. And until the globe has been effectively – been controlled around the world, it’s going to be everybody’s problem.
But Kirstin Lyke says even so, if you get the vaccine, you have to remember it’s not perfect. And you shouldn’t think a vaccine is a guarantee that you’re no longer at some risk. Lyke is a professor at the Center for Vaccine Development and Global Health at the University of Maryland in Baltimore.
KIRSTIN LYKE: This is one tool in your toolbox. You have social distancing. You have masks. You have PPE if you’re a health care worker. All of those you need to keep on using.
KELLY: And what is the timing here, Joe? When do we think the FDA will make a decision about whether to grant emergency use authorization or not to this Moderna vaccine?
PALCA: Well, as you said at the start, it could be later this week. Before they give an approval, they’ll talk with the VRBPAC. That’s the advisory committee made up of independent experts who will give them some thoughts about, you know, the package that Moderna has put together and FDA’s analysis of it.
They’ll be reminding the FDA – not that they need reminding – that they need to keep track of potential side effects. This vaccine has only been tried in a few tens of thousands of people, not millions. And so that’s important to keep track of. But it shouldn’t be too long after Thursday’s meeting.
KELLY: All right. The VRBPAC – that’s a new one for us to keep track of. NPR’s Joe Palca, thank you.
PALCA: You’re welcome.
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