Advisers to the FDA back COVID vaccines for the youngest children

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WASHINGTON, D.C. (NPR) — A committee of advisers to the Food and Drug Administration voted unanimously to recommend that the agency authorize COVID-19 vaccines from Moderna and Pfizer-BioNTech for children as young as 6 months.

The committee’s recommendations, in a pair of 21-0 votes, pave the way for the FDA to make COVID-19 vaccines available to immunize the last group of people to become eligible for them. The agency is expected to authorize the vaccines soon.

“I feel incredibly relieved,” said Jessica Herring, 33, of Upper Marlboro, Md., who has been waiting to vaccine her 2-year-old son, Glenn. “Young children can finally have some protection beyond isolation and the actions of other people. It allows myself and other parents like me to finally breath a huge sigh of relief.”

On Friday and Saturday, a committee of expert advisers to the Centers for Disease Control and Prevention is scheduled to meet and make recommendations about use of the vaccines. Then, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, will weigh in with a statement on their use.

If, as expected, she endorses them, the way would then be clear for vaccination of the youngest children to begin as soon as Tuesday.

While the risk of death and serious COVID-19 illness is lower for young children than people in older age groups, several committee members and a top FDA official said that authorization of vaccines that could protect young people from the worst outcomes would be worthwhile.

In remarks as the beginning of the day’s deliberations, Dr. Peter Marks, the FDA’s top vaccine official said that as of May 28 there had been 442 deaths from COVID-19 reported for children under 4 years old. “We are dealing with an issue where I think we have to be careful we don’t become numb to pediatric deaths because of the overwhelming number of older deaths here,” he said. “Every life is important. And a vaccine-preventable death [is one] we would like to do something about.”

The expert committee found that the benefits of the Moderna COVID-19 vaccine given as two shots four weeks apart outweigh its risks for use in infants and children 6 months through 5 years of age.

The advisers also voted in favor of the Pfizer-BioNTech COVID-19 vaccine for infants and children 6 months through 4 years of age. That vaccine is given as three shots. The first two are given three weeks apart. The third dose is given eight weeks after the second shot.

Pfizer revised its vaccination protocol during its clinical trial to include a third dose after two doses didn’t prompt a strong immune response in children ages 2 to under 5-years-old.

Rob Stein contributed to this report.

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A child receives the Pfizer BioNTech COVID-19 vaccine at the Fairfax County Government Center in Annandale, Va.
A child receives the Pfizer BioNTech COVID-19 vaccine at the Fairfax County Government Center in Annandale, Va., in November 2021. A committee of advisers to the Food and Drug Administration recommended Wednesday that the agency expand authorization of COVID-19 vaccines to children as young as 6-months-old. [Chip Somodevilla | Getty Images]

Transcript :


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. Transcript provided by NPR, Copyright NPR.