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As U.S. COVID deaths drop, FDA panel reviews data on vaccines for children

NOEL KING, HOST:

OK, we're going to go now to the latest on the coronavirus. Some good news in the U.S. - hospitalizations and deaths from COVID are falling. And this week, FDA advisers will review data on a vaccine for kids ages 5 to 11. Pfizer is going to present its data on its vaccine to the FDA this week.

NPR's Allison Aubrey is following this one. Good morning, Allison.

ALLISON AUBREY, BYLINE: Good morning, Noel.

KING: So it's a big week. What's going on?

AUBREY: Well, a committee of advisers is scheduled to meet tomorrow. They will review data submitted to the agency by vaccine-maker Pfizer. The company's clinical trial data for more than 2,000 children found the vaccine is about 91% effective against symptomatic infection. And now FDA scientists who have analyzed the data concluded over the weekend that the vaccine's benefit in preventing hospitalizations and deaths would likely outweigh any risks of potential side effects. So the agency's analysis supports authorization.

I spoke to Dr. David Kimberlin. He's a pediatrician at the University of Alabama at Birmingham.

DAVID KIMBERLIN: Having this vaccine available for 5- to 11-year-olds is not only going to protect the child but also protect the child's loved ones. You know, we've already lost over 500 children to this virus. Now with this likely authorization, I really think we're going to have a tool to be able to prevent that.

AUBREY: The FDA could deliberate swiftly after its advisory committee meets tomorrow.

KING: If the FDA authorizes the vaccine for kids, can parents go running down to the pharmacy right away, get it done?

AUBREY: Not immediately. Pharmacies won't just take the adult vaccine and give it to kids. Pfizer has made a new product, which is one-third the dose - enough to be effective but also chosen to minimize side effects. The kids vaccine will come in different packaging - in orange vials - so as not to be confused with the adult version. And these will need to be distributed out. Pharmacies will offer it, as will many pediatricians in their offices.

I spoke to pediatrician Lee Savio Beers. She's president of the American Academy of Pediatrics. She points out that the CDC will weigh in with recommendations, too.

LEE SAVIO BEERS: It does appear that there is plenty of vaccine supply available, but I think also for parents to know that it won't be an instantaneous as soon as the vaccine is recommended by the CDC. You know, it may be a day or two or three before everything is really fully up and running.

AUBREY: The same goes for other locations that will offer vaccines to kids, including pharmacies. So if authorized, early November is likely when 5- to 11-year-olds can begin to be vaccinated.

KING: Early November, OK. In the meantime, millions of adults are eligible for booster shots. And a lot of people are asking whether they need to get the same brand of booster shot as they got when they took the vaccine initially. What's the decision there?

AUBREY: People do not need to be boosted with the same vaccine they received for the first two doses. It's possible for people who got the J&J vaccine to be boosted with one of the two mRNA vaccines. There's some data to suggest that the mix-and-match approach with J&J can kind of boost antibodies to a greater extent. But the message coming from lots of experts I talked to following this closely is that all of the vaccines are effective. So mix and match could be more about convenience. You know, if you go to the pharmacy and they have only Pfizer or only Moderna, you can get the one they have. CDC Director Rochelle Walensky said Friday that the agency will not weigh in with specific advice on which one to pick.

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ROCHELLE WALENSKY: We will not articulate a preference. My understanding is that most people will have done largely well with the initial vaccine that they got. There may be some people who might prefer another vaccine over the one that they received, and the current CDC recommendations now make that possible.

AUBREY: To the extent there are some differences of opinion among doctors, it's because the science doesn't really clearly point to an optimal choice. Dr. Walensky stressed that all the vaccines are effective.

KING: All of them are effective, but if a person decides they want a particular brand, will the pharmacy give them what they want?

AUBREY: You know, it may vary. A CVS spokesperson told me, if you want to specify, you should schedule in advance to ensure it's available. CVS says, at this time, participating pharmacies offer either Pfizer or Moderna, depending on the location, not both - so best to inquire before if you have a preference. You know, this was one justification for the mix-and-match authorization - not so much to suggest that one vaccine is better than the other but just to make it more convenient. If you show up at the pharmacy for a booster, you can receive whichever brand is available.

KING: OK, so it makes the logistics a little bit easier - maybe even a lot easier.

AUBREY: Absolutely.

KING: What about booster shots? So older people and people with certain conditions are eligible at this point. Is that going to expand to include more people anytime soon?

AUBREY: It is possible. Dr. Walensky said they are actively looking at whether immunity is trailing off in other age groups. It's been reported that the FDA is actively looking at whether people 40 and up should be eligible for a booster. Dr. Walensky spoke at a White House briefing on Friday about this.

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WALENSKY: We are following the data in real time. And we are looking at its ongoing efficacy, as well as its potential for waning in our other age groups. And we will update our recommendations as soon as we have more data.

AUBREY: It could be that after the agencies get through the process of determining authorization and recommendations for younger children, they could look at boosters for these other age groups.

KING: OK. So Sunday is Halloween, and then after that we are pretty much headed full-on into Thanksgiving, Christmas...

AUBREY: Yes.

KING: ...New Year's - the holiday season. Right. What's the CDC saying about the holidays this year?

AUBREY: Well, beginning with Halloween, it is not lost on Dr. Walensky that kids absolutely love this holiday.

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WALENSKY: I would say, put on those costumes, stay outside and enjoy your trick-or-treating.

AUBREY: So good for kids to mask up if they're indoors with a crowd - most kids are used to this by now. As for Thanksgiving and beyond, with so many people eager to celebrate with friends and family, she says the more people who are vaccinated in your group, the safer the gathering will be. As of now, about 78% of people 12 and up in the U.S. have had at least one shot.

KING: NPR's Allison Aubrey. Thanks, Allison.

AUBREY: Thank you, Noel.

(SOUNDBITE OF STAN FOREBEE'S "INTROSPECTION") Transcript provided by NPR, Copyright NPR.