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FDA extends emergency use authorization of COVID vaccine for kids ages 5-11

AILSA CHANG, HOST:

The Food and Drug Administration has authorized the Pfizer-BioNTech COVID-19 vaccine for children as young as 5 years old. The decision comes just three days after an independent advisory panel strongly supported the authorization. Twenty-eight million children are set to become eligible. But shots will not become available just yet. NPR's Selena Simmons-Duffin is here to explain. Hey, Selena.

SELENA SIMMONS-DUFFIN, BYLINE: Hi, Ailsa.

CHANG: All right, so what exactly did the FDA say, then?

SIMMONS-DUFFIN: In its press release, FDA said that based on the totality of the evidence, the benefits of this vaccine for the 5- to 11-year-old age group outweigh the risks. So the formulation of this vaccine is slightly different. It's a lower dose - 10 micrograms instead of the 30-microgram dose that's used for teenagers and adults. It is a two-shot series given 21 days apart. And data submitted to the FDA showed the vaccine was safe and 90.7% effective in preventing COVID-19.

CHANG: Great.

SIMMONS-DUFFIN: But as you said, it is not over yet. So...

CHANG: Why not?

(LAUGHTER)

SIMMONS-DUFFIN: The next step in the process before the vaccine can be available at pediatricians offices and pharmacies is a meeting of an advisory panel to the CDC next Tuesday.

CHANG: Ah. OK, OK, OK. Can you just explain, like, what is the difference between all of these advisory groups? It seems like there are a lot of advisory groups all the time.

SIMMONS-DUFFIN: You are not the only person to ask me this.

CHANG: (Laughter).

SIMMONS-DUFFIN: So I kind of think of it as FDA's job to evaluate the what and CDC's job to think about the who. So the FDA part of the process is done. Now CDC's outside science advisers will consider who should this vaccine be recommended for exactly - all children in this age group, only certain children with certain risk factors? And they'll also consider things like the impact that vaccinating this group will have on community spread and school disruptions. And then they'll take a vote. Finally, CDC Director Rochelle Walensky will make an official recommendation. And if all goes according to plan, then the rollout will begin. And the Biden administration has been actively planning this. They say shots should be available pretty quickly after CDC's greenlight.

CHANG: OK. Well, I know that you've been talking to a lot of pediatricians while you've been reporting on this. What exactly are they telling you?

SIMMONS-DUFFIN: Right. So even though cases seem to be going down and kids in this age group tend to only have mild symptoms from COVID, pediatricians that I've been talking to seem to be very much on board with vaccinating kids as soon as possible. Dr. Tina Tan is a pediatric infectious disease physician at Northwestern and Lurie Children's Hospital, and here's what she's saying to parents.

TINA TAN: My position on this is they should not wait. I mean, we continue to have COVID in the community. It doesn't matter where you live in the U.S. And kids can get delta and can get quite sick from it. And you cannot predict in a normal healthy child who's going to get very sick and who's not.

CHANG: Wait. So how many kids have gotten very sick? Like, what are the numbers like?

SIMMONS-DUFFIN: Well, more than 8,000 kids in this age group have been hospitalized with COVID-19, and nearly 100 have died. And in the scope of, you know, 700,000 deaths in the U.S. overall, that might not sound like a lot, but in the context of illnesses that kill kids, it's kind of up there. It's more than the number of kids who die from flu each year. Dr. Ibukun Kalu is a pediatrician and infectious disease specialist at Duke University, and she says in her world, those relatively few kids who do get severely ill from COVID aren't just numbers.

IBUKUN KALU: We see the kid that ends up in the hospital, in the ICU, or the kid that passes away from this. And that's someone's child. So if there's anything we can do to prevent even one case, I'm in favor of it.

CHANG: But don't, like, a lot of parents still have questions? 'Cause I saw that recent polling suggests about a third of parents - only about a third of parents will get their kids vaccinated right away.

SIMMONS-DUFFIN: Yeah, that's right. And Kalu says that polling tracks with parents she's talking with. Some are really gung-ho. Some are absolutely against it. But a lot of parents just aren't sure yet, and they have questions. They're going to be weighing their options this weekend and next week, and she suggests connecting with a trusted medical professional to help think it all through.

CHANG: That is NPR's Selena Simmons-Duffin. Thank you, Selena.

SIMMONS-DUFFIN: Thank you. Transcript provided by NPR, Copyright NPR.

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