Experts support the FDA authorization of COVID vaccines for youngest children : Shots - Health News A committee of experts voted unanimously to recommend that the Food and Drug Administration authorize COVID-19 vaccines from Moderna and Pfizer-BioNTech for children as young as 6-months-old.

Advisers to the FDA back COVID vaccines for the youngest children

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The first COVID-19 vaccines for very young children took another crucial step forward today. A pivotal Food and Drug Administration advisory committee recommended that the agency authorize two vaccines for children younger than age 5. The FDA is expected to do that quickly.

And NPR health correspondent Rob Stein joins us with the details. Hi, Rob.


SHAPIRO: Looks like it's finally happening. Parents of babies, toddlers and other very young kids - looks like they're about to be able to get vaccines to protect those children. Tell us more about what happened today.

STEIN: Yeah, Ari. You know, it's been a very long journey getting here, including a very long day today. A committee of independent advisers sifted through reams of scientific data and quizzed FDA and company scientists about how well the vaccines work and any possible risks. Dr. Peter Marks from the FDA set the stage by trying to dispel the perception that COVID-19 doesn't pose a big risk for young children.

PETER MARKS: We have to be careful that we don't become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important. Each child that's lost essentially fractures a family.

STEIN: And in the end, the committee voted unanimously that no serious side effects outweigh the potential benefits. Here's Dr. Jay Portnoy from Children's Mercy Hospital in Kansas City.

JAY PORTNOY: There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them a choice to have the vaccine if they want to.

STEIN: Especially with even more contagious omicron subvariants spreading fast, so few people wearing masks anymore and kids heading off to summer camps and vacations.

SHAPIRO: So I said the recommendation is that the agency authorize two vaccines. Explain the difference between them. What are they?

STEIN: Yeah, that's right. One is a new formulation of Moderna's vaccine that contains just one quarter of the dose that adults get given in two shots spaced a month apart. The other is a very low dose version of the Pfizer/BioNTech vaccine that contains just 1/10 the dose that adults get. It's three shots given over three months. Both vaccines look like they stimulate the immune system just as well as the shots that have protected older kids and young adults from getting seriously ill.

Some data suggest the Pfizer/BioNTech vaccine may work better at protecting against getting sick at all, but that's really still kind of iffy. The Moderna vaccine does appear more likely to cause fevers, which can be a real problem in little kids, but usually aren't. Another big question is, how long will the protection from each vaccine last?

But overall, many parents are just thrilled. Here's what Jessica Herring of Upper Marlboro, Md., said to me right after the vote. She's desperate to vaccinate her 2-year-old son, Glenn.

JESSICA HERRING: I feel incredibly relieved. And I know it allows myself and other parents like me to finally breathe a huge sigh of relief.

SHAPIRO: Yeah. You can really hear that emotion in her voice. How are parents going to decide which vaccine to get for their kids?

STEIN: It could get kind of tricky. They'll have to weigh all those possible differences. You know, and I've talked to several parents about this in the last week or so who say they want Moderna because it will let them vaccinate their kids in a month instead of three, like Andrew Betts of Falls Church, Va., who has a 4-year-old daughter named Stella and a 2-year-old son named Leo.

ANDREW BETTS: I've seen a lot of reports of places only getting Pfizer, which is incredibly frustrating. If that's the only thing I can get on Day 1, then I don't want to do that. I want the Moderna.

STEIN: But, you know, Ari, it became clear during today's meeting that the Moderna vaccine will probably eventually need a third shot, too. So parents should consider that when making a decision.

SHAPIRO: Are there any other hurdles remaining for approval here?

STEIN: Yeah. The Centers for Disease Control and Prevention will weigh in on Saturday with its own recommendations. But if things go as expected, pediatricians, hospitals, clinics, pharmacies should be able to start vaccinating kids younger than age 5 for the first time beginning next Tuesday.

SHAPIRO: That is NPR health correspondent Rob Stein. Thanks for bringing us the good news.

STEIN: Sure thing, Ari.

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