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FDA advisors recommend the Novavax COVID vaccine

STEVE INSKEEP, HOST:

The United States is close to approving another COVID-19 vaccine. A Food and Drug Administration advisory committee recommended that the agency authorize it. NPR health correspondent Rob Stein told us this vaccine works differently than others.

ROB STEIN, BYLINE: It's what's known as a protein subunit vaccine because it works by injecting a protein from the virus along with a substance called an adjuvant, which kind of turbocharges the immune reaction to that protein. And a study involving about 30,000 people found two shots of the vaccine three weeks apart was about 90% effective at protecting people against COVID-19.

INSKEEP: Isn't that about the same as the vaccines we already have?

STEIN: Yeah, you're right. This Novavax vaccine looks like it probably works just about as well as the Moderna and the Pfizer-BioNTech injections. But the Novavax vaccine works in an entirely different way. It uses that much more traditional approach, a strategy that's been used for decades to make many other vaccines. So the hope is that it just may make it more appealing to some of the millions of people who still haven't gotten vaccinated, you know, people who just don't like the idea of using the brand-new mRNA technology that the Moderna and Pfizer-BioNTech vaccines use. Those vaccines inject genetic coding that turns cells its little factories that churn out a protein from the virus, and that makes some people nervous and has been the fodder for lots of misinformation that has made some people avoid getting vaccinated. Now, the FDA says the Moderna and Pfizer-BioNTech vaccines are very safe, but here's how Dr. Peter Marks from the FDA put it during a daylong meeting of the agency's outside advisers yesterday.

(SOUNDBITE OF ARCHIVED RECORDING)

PETER MARKS: A protein-based alternative may be more comfortable for some in terms of their acceptance of vaccine.

STEIN: Now, some experts are skeptical that this distinction will make much of a difference. And there are still some questions about the Novavax vaccine. It may cause the same kind of rare inflammation of the heart that sometimes occurs in people who get the Moderna and Pfizer-BioNTech vaccines. Here's Dr. Arthur Reingold from the University of California, Berkeley, one of the FDA's advisers who endorsed the vaccine at the meeting.

(SOUNDBITE OF ARCHIVED RECORDING)

ARTHUR REINGOLD: I'm hoping to be proven wrong and that there are large numbers of people who sign up for this vaccine who wouldn't take an mRNA vaccine, but count me as skeptical about that.

STEIN: It's also unclear how well the Novavax vaccine works against the omicron variant, since that strain wasn't circulating when the vaccine was tested. Several omicron subvariants are now dominant in the U.S., including two that are now on the rise that are even better at dodging the immune system.

INSKEEP: OK, I guess we don't have final-final approval then for this new Novavax vaccine. What happens next?

STEIN: That's right. That's right. The FDA will now have to decide whether to go along with the advisory committee's recommendation and authorize the vaccine. It doesn't have to, but it usually does. And if the FDA does greenlight the Novavax vaccine, the Centers for Disease Control and Prevention will weigh in with recommendations about how best to use it. We'll also have to see how much of this vaccine will actually become available. One of the reasons this vaccine wasn't authorized sooner was the company has had problems ramping up production. But another role this vaccine might be able to play is as a booster. The federal government's planning another big booster campaign in the fall to try to protect people against another potential surge next winter, and the Novavax vaccine might end up being one of the options for that.

INSKEEP: Rob, thanks very much for your reporting.

STEIN: Sure thing. It's always a pleasure, Steve.

INSKEEP: That's NPR's Rob Stein. Transcript provided by NPR, Copyright NPR.

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Rob Stein is a correspondent and senior editor on NPR's science desk.