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Pfizer says children under 5 can get 3 low-dose versions of its COVID-19 vaccine


There's some potentially good news today for parents of very young children who want to vaccinate their kids against COVID-19. Pfizer and BioNTech say three doses of their pediatric vaccine appears to be safe and effective for children under 5. NPR health correspondent Rob Stein joins us now to discuss.

Good morning, Rob.

ROB STEIN, BYLINE: Good morning.

FADEL: So many parents of these very young children have been really anxious to get their kids vaccinated. What are the companies saying?

STEIN: Pfizer and BioNTech say a study involving more than 1,600 kids shows that three doses of a very low-dose version of their COVID-19 vaccine appears to safely trigger a response by the immune system that should be strong enough to protect children as young as 6 months old. And yeah, this would be very good news because right now there's no vaccine authorized for kids younger than 5. And many parents have been feeling very frustrated and angry about that...

FADEL: Right.

STEIN: ...Especially now that infections are rising again and no one's wearing masks anymore or taking other precautions to keep the virus from spreading. Officials had hoped to have a vaccine available for these kids by now. But in December, Pfizer and BioNTech reported that two doses didn't work, and so the companies were giving kids a third dose to see if that did the trick. Today they're saying, yes, it looks like it did.

FADEL: Did the company say whether these three doses actually protect kids from getting sick?

STEIN: Well, they say that very preliminary data indicate that three doses appears to be 80% effective against preventing symptomatic disease. And that's against the omicron variant, which would be very good news, since omicron is, you know, so much better at sticking around the immune system. But there's a big caveat about this. That 80% is based on just 10 kids who got sick only about a week after getting their third shot. So that's really not enough kids to reach any definitive conclusions.

I talked about this with Dr. Paul Offit at Children's Hospital of Philadelphia. He's a member of the Food and Drug Administration Committee that advises the agency on vaccines. He noted that the companies need at least 21 children who got COVID to reach any reliable conclusions.

PAUL OFFIT: I mean, 10 children - you're talking about 10 children. It's a small number, so it's really hard to comment or this as something more general since you don't know because the numbers are so small.

STEIN: That said, Offit says the immune response could be sufficient for the FDA to authorize the vaccine. The advisers will have to see all the data to know whether to recommend it. But other experts have been in touch with this morning say the results do look promising.

FADEL: Now, this isn't the only vaccine in development for babies and very young children that the FDA will consider, right?

STEIN: That's right. That's right. Moderna is asking the FDA to authorize two doses of its low-dose vaccine for kids younger than age 5 and has already submitted data that the company says shows the vaccine is safe and effective - 37% to 51% effective - protective against omicron.

FADEL: So what happens next now?

STEIN: Pfizer and BioNTech say they'll submit their data this week to the FDA, which has already scheduled a series of meetings of its advisers for next month to consider both Moderna's and the Pfizer/BioNTech pediatric vaccines. So, you know, the agency could finally authorize a COVID-19 vaccine for babies, toddlers and other very young children in June. The Centers for Disease Control and Prevention will also weigh in. But, you know, given how anxious so many parents are for a vaccine for these littlest kids, they will likely act quickly, and a vaccine could finally become available by early summer.

FADEL: NPR health correspondent Rob Stein. Thanks, Rob.

STEIN: Sure thing.

(SOUNDBITE OF MENISCUS' "HEAD RUSH") Transcript provided by NPR, Copyright NPR.

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