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Advisory Panel Recommends FDA Approve Johnson & Johnson Vaccine For Emergency Use

SCOTT SIMON, HOST:

Millions of Americans are desperate to get vaccinated. But right now, there simply aren't enough vaccines to go around. But there's some good news. Yesterday, an independent advisory committee to the Food and Drug Administration endorsed the Johnson & Johnson vaccine.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED PERSON: Dr. Montoya, Dr. Chatterjee, yes. Dr. Fuller, yes.

SIMON: The committee voted 22 to 0 in favor. And that opens the way for the FDA to authorize its emergency use. NPR's Joe Palca was listening to the committee deliberations. Joe, thanks so much for being with us.

JOE PALCA, BYLINE: You're very welcome.

SIMON: And what did the committee base its decision on?

PALCA: Well, the committee heard from scientists both at the company and the FDA. And they were both looking at the data that came from several studies, the most important of which was a large 40,000-person efficacy study that was carried out in the United States, South Africa and six Latin American countries.

I guess the good news is that the company and the FDA by and large agreed with their analysis. The key findings were that the vaccine had 66% efficacy against moderate to severe disease overall, 72% if you just look at the data coming from the United States, and 85% efficacy against more serious disease. This was basically keeping people out of the hospital, and that number held up across all countries.

SIMON: Which sounds encouraging, but don't the vaccines from Pfizer and Moderna have better numbers?

PALCA: Yeah. Those numbers were closer to 95% efficacy. But you have to keep in mind a few things. First of all, those studies were done before these new variants started popping up. And it's possible - and laboratory results suggest that it is possible - that they won't work quite as well against the new variants. The other thing is that this vaccine did work in South Africa, where there is a variant that people are very worried about circulating. And that's good news. And the other really important thing is that this is a vaccine that can be given in one dose. So from a logistical standpoint, you come in, you get the thing, you're done. And public health officials would be very happy to have that as a tool in their arsenal when they're trying to control a pandemic.

SIMON: So what happens next?

PALCA: Well, what happens next is that the Food and Drug Administration decides whether to grant this emergency use authorization. And that will allow the vaccine to be distributed. Then the question is, how much vaccine is there? And that's been a bit of an issue. The company said in testimony earlier this week that they had 4 million doses ready to go out the door. They have 20 million doses they think they'll be able to provide by the end of March and 100 million by the end of June. And keep in mind that each dose is one person vaccinated. So, you know, it's a one-to-one thing.

SIMON: Joe, we've been hearing some of the vaccines out there right now might have to be modified because of the new coronavirus variants that are spreading. Does that mean the companies will have to do another study of 40,000 people if they modify the vaccines?

PALCA: No. That's something the FDA has thought about. They issued guidance earlier this week. They have said that they will be satisfied with much smaller studies just to make sure that the vaccines are safe. They'll be particularly eager to see that the same techniques were used to create the vaccines. And they'll be looking at laboratory data that will help convince them that a modified vaccine will work as well as the original vaccine.

SIMON: NPR's Joe Palca, thanks so much.

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