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Moderna edges toward FDA emergency use authorization for pediatric COVID-19 vaccine


There is potentially some very good news today for parents of young kids who have been anxious to get their children vaccinated. Moderna says a pediatric version of its COVID-19 vaccine appears to be safe and effective. NPR health correspondent Rob Stein joins us now. Hey, Rob.


SUMMERS: All right, Rob, so who exactly would this vaccine be for?

STEIN: Yeah. So Moderna has been testing lower dose versions of its vaccine for kids of all ages. But it's parents of kids younger than age 5 who might be most excited about this. That's because anyone age 5 and older can already get the Pfizer-BioNTech vaccine. But Pfizer's vaccine hasn't really worked so far for kids this age. So many parents have been frustrated, especially now that everyone is taking off their masks. But Moderna announced today that a pediatric version of its vaccine appears to be safe and can protect kids ages as young as 6 months old.

SUMMERS: That is potentially a big deal. Rob, how strong is the evidence here?

STEIN: That's a very good question. Unfortunately, all we really know about this so far is what Moderna put out in a news release this morning. First of all, Moderna says doctors didn't see any signs of any serious side effects when they gave thousands of kids two doses of the company's vaccine at one-quarter of the dose that adults get. And the company says this low-dose formulation looks like it was high enough to stimulate the immune system just as well as the adult version. Moderna says it generated levels of neutralizing antibodies equivalent to what protects adults. I talked about this with Dr. Yvonne Maldonado. She's a Stanford pediatrician who advises the American Academy of Pediatrics. She says this is really good news for lots of parents.

YVONNE MALDONADO: It's been difficult. And most heartbreaking, I think, are the children who are immunocompromised who have other underlying conditions, who can't be vaccinated yet. And so it will be a welcome opportunity for families to vaccinate their young children as they have been able to do for their older kids.

STEIN: But, you know, there are still lots of questions about all this.

SUMMERS: What sorts of questions are there?

STEIN: Well, you know, Moderna also says the vaccine was only about 40% effective against the omicron variant in terms of protecting the kids against catching the virus and getting mildly or moderately ill. That's not unexpected since the adult vaccine doesn't work as well against omicron either, but it's not great. So the company says it plans to test a third dose, a booster, to see if that helps. And while the immune response should be enough to do the most important thing, you know, keep kids from getting seriously ill, that hasn't actually been proven yet. And even if it does, you know, no one knows really how long that protection might last. I talked about this with Dr. Jesse Goodman. He's a former top FDA scientist who's now at Georgetown University.

JESSE GOODMAN: I would say these are promising results. It's not a home run because it doesn't eliminate most infections, but it's promising.

STEIN: Goodman also says Moderna's study wasn't big enough to totally rule out any side effects, you know, like a rare heart inflammation that sometimes occurs among younger men.

SUMMERS: All right, Rob, so where do we go from here? What happens next?

STEIN: Moderna plans to formally ask the FDA for emergency authorization within weeks. The FDA would probably convene outside advisers to put the company's case under a microscope and decide whether or not to recommend a go-ahead. If it does, the CDC would then weigh in. All that could happen pretty fast. And Pfizer's expected to announce the results of a third dose of its pediatric vaccine soon, too. But these shots have to be given three or four weeks apart and then probably followed by a third shot months later. So it'll probably take time to get all these little ones fully vaccinated. And the big question is, how much of a demand will there really be at this point?

SUMMERS: Rob, in the few seconds we have left, what do we know about that?

STEIN: You know, many parents clearly can't wait to vaccinate their kids, but it's already been hard to convince most to vaccinate their older kids; less than a third have done it. And with the omicron surge waning, there may be even less a sense of urgency for many, especially since kids don't tend to get that sick.

SUMMERS: NPR health correspondent Rob Stein, thank you.

STEIN: Sure thing. Transcript provided by NPR, Copyright NPR.

Rob Stein is a correspondent and senior editor on NPR's science desk.