© 2021
background_fid.jpg
Play Live Radio
Next Up:
0:00
0:00
Available On Air Stations

The FDA Is Looking At The Benefits Of Booster Shots And Vaccinating Kids Under Age 12

AUDIE CORNISH, HOST:

NPR has confirmed that leaders of two federal health agencies want the White House to rethink its plans to roll out COVID-19 vaccine boosters to the general public later this month. The FDA is also waiting for data from pediatric trials before it can determine whether COVID vaccines could be authorized for children under the age of 12. NPR's Allison Aubrey has the latest on this reporting.

And, Allison, I want to start with the first thing we mentioned. The administration's top COVID advisers basically made a splash last month when they, like, announced this plan to offer booster shots to the general public. And they even had a hard date - September 20. Is that plan changing?

ALLISON AUBREY, BYLINE: Yeah, it seems to be. On Wednesday, Dr. Peter Marks, a senior FDA official, reiterated that the process for authorizing the use of a booster dose involves each vaccine manufacturer submitting data on safety and on effectiveness. So far, the agency is evaluating data submitted by Pfizer. That's in progress but not yet finished. And today, as first reported by The New York Times and confirmed by NPR, health officials within the CDC and FDA have advised the White House to kind of scale back the booster plan for now because they may not have all the information they need by late September, Audie. Acting FDA Commissioner Janet Woodcock said in an interview with WebMD they don't have all the safety data yet.

(SOUNDBITE OF ARCHIVED RECORDING)

JANET WOODCOCK: Those studies have been completed and should be available to the FDA soon.

AUBREY: So the message coming from the FDA is, you know, we're on it, but this process takes time.

CORNISH: What is the evidence at this point that a booster dose could be beneficial?

AUBREY: Well, in a White House briefing yesterday, Dr. Anthony Fauci presented data from Israel supporting a booster in adults 60 and older. The study looked at more than a million people who had received a third shot of the Pfizer vaccine, and it showed a significant reduction in the risk of infection and severe disease.

(SOUNDBITE OF ARCHIVED RECORDING)

ANTHONY FAUCI: There's no doubt from the dramatic data from the Israeli study that the boosts that are being now done there and contemplated here support very strongly the rationale for such an approach.

AUBREY: But, again, Audie, the FDA still needs to review safety and efficacy data from the vaccine makers.

CORNISH: The other question out there is, of course, about children because the number of cases is rising - right? - in that population.

AUBREY: Yes.

CORNISH: Parents want to know when might vaccines be available for kids under the age of 12.

AUBREY: Right. Well, again, this is pending FDA review, but Pfizer has said it expects to have enough data later this fall to support an emergency use authorization for its vaccine in children ages 5 to 11. It's a similar timeline for Moderna. I spoke to the company about what they're seeing so far in their pediatric trials, which have been expanded recently to be able to pick up any adverse reactions to the vaccine. Here's Dr. Jacqueline Miller, a senior vice president at Moderna.

JACQUELINE MILLER: The safety profile so far is really comparable to the adults, and so far, no safety concerns. And then for the moment, we're targeting at the end of the year for the 6- to 11-year-olds and early next year for the 6-month-olds to 6-year-olds.

CORNISH: Allison, what does the FDA say about that?

AUBREY: Well, acting Commissioner Woodcock has said that she certainly hope so. She says the agency completely understands the urgency and why parents are asking. But, again, they need to see the data, and some of the studies are still ongoing.

CORNISH: That's NPR's Allison Aubrey.

Thank you.

AUBREY: Thank you, Audie. Transcript provided by NPR, Copyright NPR.