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

Children are one step closer to qualifying for the COVID-19 vaccine after the Food and Drug Administration allowed emergency use of the Pfizer vaccine for children aged 5-11.



Elsa Chang, Host:

The Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine for children under 5 years of age. The decision came just three days after an independent advisory panel backed the permit. Twenty-eight million children are ready to become eligible. But shots will not be available yet. NPR’s Selena Simons-Duffin is here to explain. Hey, Selena.

Selena Siemens-Daphne, Byline: Hello, Elsa.

Chang: Well, then what exactly did the FDA say?

Siemens-Daphne: In its press release, the FDA said that based on the combined evidence, the benefits of this vaccine far outweigh the risks for the 5- to 11-year-old age group. Therefore, the composition of this vaccine is slightly different. This is a low dose – 10 micrograms instead of the 30 microgram dose used for teens and adults. This is a two shot series with an interval of 21 days. And data submitted to the FDA shows that the vaccine was safe and 90.7% effective in preventing COVID-19.

Chang: Very good.

Siemens Daphne: But as you said, it’s not over yet. You …

Chang: Why not?

(Laughter)

Siemens-Daphne: The next step in the process before the vaccine becomes available in pediatricians’ offices and pharmacies is a meeting of the advisory panel at the CDC next Tuesday.

Chang: Ah. Ok ok ok Can you just explain, like, what is the difference between all these advisory groups? There seem to be a lot of advisory groups all the time.

Siemens Daphne: You’re not the only one asking me that.

Chang: (laughs)

Siemens-Daphne: So I think in a way it’s the FDA’s job to review what and what the CDC’s job is to think about. So the FDA has become part of the process. The CDC’s external scientific advisers will now consider exactly who the vaccine should be prescribed for – all children of this age, with only a few specific risk factors. And they will also consider things like how the vaccination of this group will affect the spread of the community and school barriers. And then they will vote. Finally, CDC Director Rochelle Valensky will make an official recommendation. And if everything goes according to plan, then the rollout will begin. And the Biden administration is actively planning it. He says the shots should be available soon after the CDC’s green light.

Chang: All right. Well, I know you’re talking to a lot of pediatricians when you’re reporting on this. What exactly are they telling you?

Siemens Daphne: All right. So although it seems that cases are declining and children of this age have only mild symptoms of COVID, the pediatricians I am talking to seem to have a lot on board with children getting vaccinated as soon as possible. There are more. Dr. Tina Tan is a pediatrician at Northwestern and Lori Children’s Hospital, and here’s what she’s telling her parents.

Tina Tan: My point is that they shouldn’t wait. I mean, we have COVID going on in the community. It doesn’t matter where you live in the United States and children can get delta and get very sick. And you can’t predict in a normal healthy child who will get very sick and who won’t.

Chang: Wait. So how many children have become very ill? Like, what are the numbers?

Siemens Daphne: Well, more than 8,000 children this age have been hospitalized with COVID-19, and about 100 have died. And you know, with a total of 700,000 deaths in the United States, that may not seem like much, but in the context of the diseases that kill children, it’s one of a kind. That’s more than the number of children who die of the flu each year. Dr. Ibukun Kalu is a pediatrician and infectious disease specialist at Duke University, and she says that in her world, the relatively few children who become seriously ill with COVID are not the only ones.

Abukin Kalu: We see a child who is in the hospital, in the ICU, or a child who dies from it. And this is someone’s child. So if we can do something to stop a case, I’m in favor of it.

Chang: But a lot of parents still don’t have questions? ‘Because I saw the recent poll suggest one-third of parents – only one-third of parents will vaccinate their children immediately.

Siemens Daphne: Yes, that’s right. And Kalu says the polls are with the parents she is talking to. Some are really dumb. Some are totally against it. But many parents are still unsure, and have questions. She is going to consider her options this weekend and next week, and she suggests contacting a reputable medical professional to help you think about it.

Chang: This is NPR’s Selena Siemens-Daphne. Thank you, Selena.

Siemens Daphne: Thanks.

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