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FDA Considers Emergency Authorization For Johnson & Johnson Vaccine

RACHEL MARTIN, HOST:

The Food and Drug Administration is getting ready to authorize a third COVID-19 vaccine for emergency use in the U.S. This could happen as early as today. This vaccine is from pharmaceutical giant Johnson & Johnson. But unlike the other two vaccines - the ones from Pfizer and Moderna - this one only needs a single dose to be effective. We've got NPR science correspondent Joe Palca with us this morning. Hi, Joe.

JOE PALCA, BYLINE: Morning, Rachel.

MARTIN: So you and I talked earlier this week after this important assessment had been done about this Johnson & Johnson vaccine. Remind us; what is the effectiveness rate for this one?

PALCA: Well, it's good. It's about 66% effective in preventing moderate to severe disease and 85% protective against more serious disease and keeping people out of the hospital and death. So that's good. Now, this may not sound as good as the Moderna and Pfizer vaccines. They were closer to 95% effective. But those vaccines were tested before some of these new variants started circulating. And preventing 85% of severe disease is really good since that's the goal - is keeping people out of the hospital.

Public health officials are also very happy to have a vaccine they only have to give once, and that's the case with the Johnson & Johnson vaccine. This is how Anthony Fauci, chief medical adviser to the president, put it on NBC's "Today" show.

(SOUNDBITE OF TV SHOW, "TODAY")

ANTHONY FAUCI: To have them come in and be in the mix with the other two is nothing but good news.

MARTIN: So before it gets in the mix, it's got to get authorized. And there's this advisory board that has to give its approval, and that's what's happening today, right? And this is standard practice.

PALCA: Exactly. Standard practice - yes, more or less. This committee is not a requirement, but it is something that the FDA said from the beginning, look; we're going to be as transparent as we possibly can; we don't want anybody think we're rushing these vaccines onto the market before we know they're safe and effective. So we're going to have this VRBPAC meeting. I'm sure you know that VRBPAC stands for the Vaccines and Related Biological Products Advisory Committee.

MARTIN: VRBPAC, yeah.

PALCA: But it's made of scientists and doctors with a variety of specializations related to vaccines. But VRBPAC will chew on the evidence that Johnson & Johnson has collected and give its opinion to FDA. And before the meeting, the FDA provides a committee with analysis of Johnson & Johnson's vaccine, and that's what we talked about earlier this week. Bruce Gellin, president of the global immunization at the Sabin Vaccine Institute, has looked over that analysis.

BRUCE GELLIN: I didn't see anything in it that I would think is going to be a showstopper for VRBPAC to want to recommend that FDA act on for an EUA.

PALCA: And that EUA stands for emergency use authorization. So Gellin is predicting that VRBPAC will give the vaccine a thumbs-up.

MARTIN: All right. VRBPAC will give the thumbs-up to the EUA. I'm learning so much from you, Joe - so many acronyms.

PALCA: (Laughter) Yup.

MARTIN: So how many doses is Johnson & Johnson going be able to supply if they do get the green light here?

PALCA: Well, in congressional testimony on Tuesday, Johnson & Johnson executives said they had about 4 million doses of the vaccine - would be available in the U.S. if an emergency use authorization comes through. They think they'll have 20 million doses by the end of March, and the company could deliver a hundred million doses by the end of June. And remember; each dose is a complete shot. You don't need a second dose.

MARTIN: Right. And this decision could be rendered today or in coming days. NPR's Joe Palca. Thank you, as always, Joe.

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