FDA advisers endorse Novavax COVID vaccine : Shots - Health News Advisers to the Food and Drug Administration overwhelmingly voted to recommend that it authorize Novavax's two-dose vaccine against COVID-19.

Advisers to the FDA back Novavax COVID vaccine

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MARY LOUISE KELLY, HOST:

Another COVID-19 vaccine just inched much closer to becoming available in the U.S. A key federal advisory committee today recommended the Food and Drug Administration authorize the vaccine.

Let's bring in NPR health correspondent Rob Stein. Hey, Rob.

ROB STEIN, BYLINE: Hey, Mary Louise.

KELLY: OK, so this new COVID vaccine has now won the endorsement of this FDA committee. And this vaccine is different from the ones we've already got because - why, remind me?

STEIN: Yes, that's absolutely right. And what makes it different from the other vaccine is that it uses a much more conventional approach to stimulate the immune system. You probably remember the Moderna and Pfizer-BioNTech vaccines inject genetic code for making a protein from the virus into the body. This vaccine, which is made by a company called Novavax, injects a version of that protein itself. And the vaccine also uses a substance designed to fire up the immune system even more, known as an adjuvant. It's made from the bark of a tree that grows in South America.

The vaccine's already been used pretty widely in other countries. Today, that FDA advisory committee voted overwhelmingly to recommend the agency authorize the Nova (ph) vaccine for anyone ages 18 and older after concluding that two shots three weeks apart appear to work just about as well as the Moderna and Pfizer-BioNTech vaccines. Now, the vaccine may cause a swelling of the heart in rare cases - that's also occurred in some people getting the other vaccines - but that link remains unclear, and the FDA advisors concluded the potential benefits of the Nova vaccine outweigh any risks.

KELLY: Although I'm still trying to figure out - if the committee thinks the Novavax vaccine appears to be on par, workabout (ph), as well with the vaccines we already have, is the advantage here that people who haven't been persuaded to get the vaccines already out there might try this new one?

STEIN: Bingo. You hit it right - the nail right on the head, Mary Louise. The thinking is this vaccine could entice some of those people who still haven't gotten vaccinated to finally get protected. You know, about one-third of people who are eligible are not fully vaccinated, which is a big reason why hundreds of people are still dying every day from COVID-19.

The Nova vaccine could be used by people who can't take the Moderna or Pfizer-BioNTech vaccines for some reason - like, you know, maybe they're prone to severe allergic reactions. And there's also the hope that it might be more acceptable to people who are nervous about the new genetic technology Moderna and Pfizer-BioNTech use or believe some of the misinformation about those vaccines, even though the FDA has found both of those vaccines to be safe and effective. Here's how Dr. Peter Marks from the FDA put it at the start of today's daylong hearing.

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PETER MARKS: We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do.

STEIN: Now, of course, it remains to be seen just how many people might be swayed by the availability of the Novavax vaccine. And, you know, some committee members today expressed skepticism that many would be.

Another big open question is how well it works against the omicron variant, which wasn't circulating when the vaccine was tested. Several committee members expressed frustration that the company didn't provide any data about that.

KELLY: And real quick, Rob - just a few seconds - what happens now?

STEIN: Well, the FDA has to decide whether to accept the advisory committee's recommendation and authorize the vaccine. The agency doesn't have to, but it usually does.

KELLY: All right. NPR health correspondent Rob Stein. Thanks, Rob.

STEIN: Sure thing, Mary Louise.

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