FDA advisers meet this week on the future of COVID-19 vaccines（在线收听）

FDA advisers meet this week on the future of COVID-19 vaccines

Transcript

FDA advisers meet Wednesday on the future of COVID vaccines. A fall booster push may be in works. And data is expected this month on vaccine efficacy in kids younger than five.

RACHEL MARTIN, HOST:

Advisers to the Food and Drug Administration meet this week to talk about the future of COVID boosters. Since many Americans haven't even gotten a first booster, the policymakers have to figure out how to persuade people to get another shot. The FDA also expects more data to roll in from vaccine trials in kids under the age of 6. But will it be convincing enough to win authorization and sway parents? NPR's Allison Aubrey is with us this morning. Hey, Allison.

ALLISON AUBREY, BYLINE: Good morning, Rachel.

MARTIN: Sounds like FDA advisers have a full plate.

AUBREY: That's right. There are just a lot of unanswered questions about where to go from here with vaccines. The agency has already given the green light for a second booster for people 50 and up. But when should they get it? And should they hold out for a variant-specific booster, the type being tested now? Will everyone be encouraged to get a COVID shot every year, maybe every fall? Many scientists say we're headed in that direction. Josh Sharfstein is a former FDA official and public health professor at Johns Hopkins University. He says there are just a lot of questions.

JOSH SHARFSTEIN: I really think it's going to be increasingly important for there to be more information from the experts at FDA about how they're thinking of these key questions. And I think this advisory committee meeting is the right step.

AUBREY: The goal is to gain the trust of people, he says, and show that there is a long-term strategy.

MARTIN: So you mentioned this, Allison. People over the age of 50 can now get this second booster. But what is the best way for folks to think about that choice?

AUBREY: I think two key factors to consider are age and overall health. A person in their 50s who is healthy is at lower risk of serious illness than someone the same age who has a bunch of underlying conditions. Bottom line - risk increases kind of incrementally with age. Dr. Robert Wachter of the University of California at San Francisco says when he thought about his own decision, he told me the answer was clear.

ROBERT WACHTER: You know, I'm 64, pretty healthy, but the evidence is clear that six months out from my first booster, the effectiveness of that booster has waned considerably. And now there's quite good evidence that another booster will decrease the probability I'll get infected and also decrease the probability that I'll die.

AUBREY: That's a lot of potential benefit, he says. But bottom line - the older the person, the stronger the case for another booster now.

MARTIN: OK. Well, let me ask this because millions of people in the U.S. have had recent COVID infections, myself included...

AUBREY: Are you positive now? You just got it?

MARTIN: I currently am positive. We're at the tail end, and I don't have symptoms anymore, but it sort of lingers in your body for a while.

AUBREY: So you're feeling OK?

MARTIN: I'm feeling fine. But the question really is, you know, if I'm eligible - I'm not over 50 yet, but when I become eligible for another booster, do I need to get it? Because aren't I supposed to have, like, this new immunity because I've had COVID?

AUBREY: Right. Well, a recent infection can certainly help boost immunity and protect you after you've been infected, at least in the short term, you know, not in the long term. So Dr. Wachter says - you know, his take is that it may make sense for people in this situation with having recent infections to hold off.

WACHTER: So if you've had three shots and you had an omicron infection sometime between December and now, I would say stick. I think you're probably in a similar immunologic state as if you got your second booster. So that group, I think it's reasonable to wait.

AUBREY: Now, no one knows what's ahead. I mean, right now, the BA.2 variant, which has been problematic in the U.K. and Europe, has led to a bit of an uptick here in the U.S. in about a dozen states or so over the last couple weeks, including in New York and Massachusetts. But big picture, nationwide - cases, hospitalizations and deaths all continue to decline.

MARTIN: Nevertheless, I mean, we celebrate this, but there's always some uncertainty, right?

AUBREY: You know, the virus just likes to throw curveballs, so it's never certain. But the consensus among all the infectious disease experts I talk to is that a big surge is very unlikely now, simply because, as a nation, we've built up so much immunity through vaccines and through the big winter omicron wave. There is, however, a concern for next fall when outbreaks or a surge could be more likely as people move indoors. That's what we've seen the last two falls and winters. Again, this has some people wondering about the timing of a booster since the protection from a booster can be short lived. I talked to Dr. Yvonne Maldonado - she's a pediatrician and researcher at Stanford - about this timing conundrum.

YVONNE MALDONADO: And the question is, do I get a booster soon? And, you know, by September, will I need another booster for the fall? Or should I wait as long as possible and get a booster that might help me through a potential fall surge? I do think that a second booster at some point could be useful for most people. I'm just not sure everyone needs one right this minute.

AUBREY: Eventually, she says, boosters may also be recommended for children. Right now, elementary school-aged kids are authorized for two shots, the 5-to-11-year-olds.

MARTIN: Indeed. But let's talk about the young ones because there's still all those parents who are like, when can I vaccinate my baby and my toddler?

AUBREY: That's right. There is a lot expected to happen over the next several weeks. Moderna is expected to give the FDA data from its trial in kids under the age of 6 to evaluate. The company has indicated that the vaccine was about 38% effective at preventing infection in kids 2 to 6, about 44% in younger kids 6 months to 2 years. Now, this might not sound great, but at this point, preventing infection is not as important as preventing severe disease. And the company has said no severe cases of COVID were seen in these children. Now, there's some debate about whether this data is going to be good enough. So Dr. Maldonado says all eyes are on the FDA now.

MALDONADO: We don't have a perfect set of vaccines yet. Given the options that we have, I think FDA is going to say let's not make the perfect the enemy of the good. Do we have a safe vaccine? Absolutely.

AUBREY: And given vaccines have been very effective in preventing serious illness in older kids, there's momentum to get something approved for the younger ones. The FDA will also likely review data from Pfizer, which extended its trial to test a third dose in young children. The company has said it will have the third dose protection data this month.

MARTIN: NPR's Allison Aubrey. Thanks, Allison. We appreciate it.

AUBREY: Thank you, Rachel.