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FDA Considers Johnson & Johnson COVID-19 Vaccine For Emergency Use Authorization

AUDIE CORNISH, HOST:

The number of confirmed COVID-19 cases in the U.S. has ticked up in recent days according to the Centers for Disease Control and Prevention. And that adds urgency to a decision the Food and Drug Administration will soon make - whether to authorize Johnson & Johnson's COVID-19 vaccine so it can be rolled out to help slow the pandemic. The FDA has asked a committee of independent experts to weigh in before it makes a decision. That committee voted late today in favor of authorization. NPR's Joe Palca listened to the all-day meeting. He's back to talk about it. And bring us up to speed as to what happened today, Joe. Who's on this committee, and what exactly were they voting on?

JOE PALCA, BYLINE: Well, it's a committee made up of experts in a variety of scientific and medical fields, all of which, of course, are related to vaccines. And as for what they were being asked to vote on, here's the FDA's Maria Allende.

(SOUNDBITE OF ARCHIVED RECORDING)

MARIA ALLENDE: Based on the totality of scientific evidence available, do the benefits of Janssen COVID-19 vaccine outweigh its risks for use in individuals 18 years of age and older?

PALCA: Janssen is the vaccine division of Johnson & Johnson.

CORNISH: Was the vote unanimous?

PALCA: Yes. In fact, it was - 22 to nothing. That's not to say there weren't some questions. I mean, they listened to data. They listened to presentations from the company. They listened to presentations from the Food and Drug Administration. They listened to presentations from the CDC about how vaccines that have already been rolled out are working and whether there are any side effects that have been detected. And so some of the questions that they had for the sponsor, Janssen, related to whether or not this vaccine was going to work in everyone. But in the end, they were convinced that it would work well enough in enough people.

CORNISH: Where did the evidence the committee considered - where did it come from?

PALCA: Well, they were mostly looking at results from a study of about 40,000 people that were - was conducted in Latin America, South Africa and the United States. And the results were positive. They were 60% efficacy overall if you look at moderate to severe COVID disease. If you just look at the data coming from the U.S., it was 72% efficacy for moderate to severe disease. If you look at diseases that were more serious or people that wound up going into the hospital, the efficacy went up, in some cases to 85% or more as a sign of efficacy. And that's significant because what you want to do with a vaccine is prevent hospitalization and death.

CORNISH: In the meantime, how many doses are ready to be shipped?

PALCA: Well, one thing I should say is that this is a vaccine that only requires a single dose per person. And so if the EUA is awarded, there'll be 4 million doses right away, according to the company, 20 million by the end of March and 100 million by the end of June. And we should know whether the EUA is given within a few - maybe even this weekend.

CORNISH: That's NPR's Joe Palca. Joe, thank you.

PALCA: You're welcome. Transcript provided by NPR, Copyright NPR.