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Pfizer-BioNTech seek FDA authorization for 2nd COVID booster for older adults

A MARTINEZ, HOST:

Numbers from the CDC show nearly 67% of fully vaccinated people over the age of 65 have gotten a booster shot. Pfizer and BioNTech want the FDA to authorize yet another one for that age group. NPR health correspondent Rob Stein says the idea is to bolster waning immunity.

ROB STEIN, BYLINE: It's become clear that the protection people get from three shots fades over time, especially against catching the virus. And that's especially true with omicron, which is better at evading the immune system than earlier versions of the virus. Now, you know, three shots still do a very good job of keeping most people from getting so sick they end up in a hospital or die, but there has been rising concern about those who are the most vulnerable, like the elderly. They tend to have weaker immune systems to start with, so some other countries have started giving older people yet another booster.

MARTINEZ: So what do you think? I mean, is the FDA likely to authorize another booster?

STEIN: You know, it really depends on how strong a case the agency thinks the companies are making. It's based on two studies from Israel that have produced some evidence that a fourth shot could help pump the immune system back up and restore some protection against getting seriously ill. I talked about this with Dr. Eric Topol at Scripps Research. He's convinced there's enough evidence to warrant another round of boosters.

ERIC TOPOL: We need to move on this because there are a large number of people who have lost their protection against severe illness from omicron and future variants.

STEIN: So Topol thinks it's urgent to start making another booster available to the elderly, especially in case omicron starts to surge again or another dangerous variant emerges.

MARTINEZ: But not everyone is as convinced as Dr. Topol.

STEIN: Yeah, that's right. That's right. Many experts I've been talking with basically say it may still be just too premature to start another round of boosters. They say the Israeli data is far from a slam dunk that another shot is necessarily needed and would necessarily help. Here's Dr. Jesse Goodman. He's a former FDA chief scientist who's now at Georgetown University.

JESSE GOODMAN: I think you'd want to have really convincing evidence that a second booster was needed and beneficial, and we just don't have that yet. I don't think we know that a booster will not ultimately be required generally, but I think we're just not there yet.

STEIN: And some experts I talked to say the country should focus instead on getting the millions of people who are still not vaccinated at all to get their shots and get boosters into the arms of the millions of vaccinated people who still haven't gotten their third shots. You know, only about two-thirds of those age 65 and older have gotten their third shots, their boosters.

MARTINEZ: All right, Rob, so what happens now?

STEIN: The FDA will consider the request and make a decision. You know, the agency could ask a committee of outside advisers to give advice, but it doesn't necessarily have to. And one possibility is that the FDA authorizes the fourth shot and then leaves it up to the CDC about whether to recommend it or, you know, just have it ready for whenever the evidence becomes clear it's really needed. The FDA is, however, planning to convene outside advisers next month to consider where we go from here with the vaccines more generally, including whether we need a broader booster campaign, perhaps in the fall, that would include younger people, too. They may also discuss whether those shots should be annual or, you know, the same vaccine or something else, like a vaccine targeted specifically at variants or maybe at, you know, protecting people against all coronaviruses.

MARTINEZ: That's NPR health correspondent Rob Stein. Rob, thanks a lot.

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

Rachel Martin is a host of Morning Edition, as well as NPR's morning news podcast Up First.
Rob Stein is a correspondent and senior editor on NPR's science desk.