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Moderna Applies For FDA Emergency Use Authorization For Coronavirus Vaccine


Today, the drug company Moderna asked the Food and Drug Administration to clear its experimental COVID-19 vaccine for emergency use. The company's case for approval is bolstered by new data showing that the vaccine appears to be remarkably effective. The FDA's decision could come in a matter of weeks. Joining us with the latest is NPR science correspondent Richard Harris.

Hi, Richard.


SHAPIRO: Let's start with that new data. We heard a couple of weeks ago that the Moderna vaccine looked promising. What's the update on that?

HARRIS: That's right. You know, the previous hopeful announcement was based on data from about 100 volunteers who got sick with COVID-19 out of some 30,000 who volunteered to get either the vaccine or a placebo. And now another 100 or so people have gotten sick. And the vast majority of those people are in the placebo shot group, not the real shot group, which means, really, the real shot's working well. Moderna president Dr. Stephen Hoge says that's exactly what they've been hoping for.

STEPHEN HOGE: We really want to stop this thing cold and provide a durable protection against the disease.

HARRIS: The vaccine is 94% effective, they say, which is about the same as other - the other vaccine that's under FDA review, and that's the product by Pfizer and its German partner BioNTech.

SHAPIRO: What's been the reaction since Moderna announced those latest results this morning?

HARRIS: Well, of course, people want to see the actual data. But on the face of it, it seems like really good news. I talked to Dr. Bob Wachter, who is the chair of the Department of Medicine at the University of California, San Francisco. He was especially happy to see that nobody who got the vaccine in the Moderna study got seriously ill.

BOB WACHTER: And it really is a game-changer if it turns out that these vaccines not only prevent cases of COVID but essentially bring to zero the number of people that are going to get super sick.

HARRIS: And Ari, you know, Pfizer reported a similar pattern for its vaccine, so that's really hopeful. Now, I should say, we don't know whether these vaccines actually prevent the spread of COVID-19, but that is not essential for stopping the pandemic. If vulnerable people are vaccinated, they can't get sick. And once enough people are vaccinated, the pandemic will stop killing hundreds or thousands of people a day, as it's doing right now. A vaccine that stops transmission could end the pandemic sooner. That's true. But, you know, a highly effective vaccine is really what's most important. That is, as long as people step up to get it.

SHAPIRO: Richard, while it feels like this has been the longest year in memory, let's remember that nobody even knew this coronavirus existed a year ago. So this must be record time to develop a vaccine, right?

HARRIS: There's no question about that. The Moderna vaccine is based on a snippet of genetic material from the virus. And you know, once scientists learned that genetic sequence back in January, they were off to the races to produce this experimental vaccine. Wachter is increasingly optimistic that the vaccine will successfully bring the pandemic under control.

WACHTER: I don't think we had a Plan B. As you well know, you know, we've been trying with HIV for 30 years, and we don't have an effective vaccine. It was not a slam dunk that we were going to find vaccines that worked.

HARRIS: And part of the successful strategy here was not only jumpstarting the science but, you know, also producing millions of doses of the vaccine with taxpayer dollars and setting up a distribution system so if the vaccine did work, health experts could start using it quickly.

WACHTER: It's a remarkable testament to the science. But I have to say, as someone who's been very critical of the administration, on this one, they got it right.

SHAPIRO: I'm sure everybody's anxious to know when this would be available. So what's the next step for the FDA now that it has the application?

HARRIS: Yeah, the FDA's job is to look at both the effectiveness and the safety of new drugs. And safety is especially important when it comes to a product that will be given to many millions of healthy people. So Moderna has been tracking people who got the vaccine. Some report aches and pains, you know, sore arms and a malaise that can last a day or so. But, you know, Dr. Hoge says, so far, it seems that - to have about the same side effects as other vaccines.

HOGE: Hopefully - again, fingers crossed - that continues to play out. It's important to note we're still collecting safety data. We will follow the participants on this study for two whole years to make sure that we have long-term safety and efficacy data on it. But so far, so good.

SHAPIRO: But people don't have to wait two years for the vaccine to be available. What is the timeline?

HARRIS: Right. Right. After the FDA staff scientists have had a few weeks to reanalyze all this data, they'll bring it to an advisory committee to discuss the application in a public session. Moderna expects that to be around December 17, so the FDA's decision could come pretty quickly right after that.

SHAPIRO: That's NPR science correspondent Richard Harris.

Thank you.

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

Award-winning journalist Richard Harris has reported on a wide range of topics in science, medicine and the environment since he joined NPR in 1986. In early 2014, his focus shifted from an emphasis on climate change and the environment to biomedical research.
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