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Advisers vote on whether FDA should authorize Pfizer COVID vaccine for kids


Children as young as 5 may soon be able to get vaccinated against COVID-19. Today an FDA panel voted overwhelmingly in favor of Pfizer and BioNTech's application to give a lower dose of its vaccine to children ages 5 to 11. The vote came after a daylong public meeting. NPR's Selena Simmons-Duffin was watching it and is here to tell us what happened.

Hi, Selena.


MCCAMMON: OK, so tell us specifically. What did the panel vote on today?

SIMMONS-DUFFIN: So the scientists were considering the question, do the benefits of vaccinating this age group outweigh the risks? And as you said, the question was overwhelmingly approved. There were 17 yes votes and one abstention. The scientists on the panel came to that conclusion after lots of presentations from Pfizer and federal scientists. They looked at the context of the pandemic, the risk of COVID-19 for these kids but also the impact to the broader community along with concerns about school disruptions. And they also reviewed data from Pfizer's clinical trial of more than 2,000 children. And that found the vaccine, which was given as a third of the adult dose, was about 91% effective against symptomatic COVID-19 with no serious safety concerns - no cases of myocarditis or anaphylaxis, for instance.

MCCAMMON: So you've been listening to the discussion today, Selena. What were some of the highlights?

SIMMONS-DUFFIN: Well, the action really came at the end. After all the presentations and public comments, there was a lively discussion among the voting members. Some of the advisers floated the idea of only authorizing this vaccine for certain children or families. Here's Dr. James Hildreth of Meharry Medical College.


JAMES HILDRETH: I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children to achieve that just seems a bit much for me. So I'm having some challenges with this one.

SIMMONS-DUFFIN: Others responded it's hard to know who would really be at higher risk. And that might not capture kids who, for instance, are healthy themselves but live with vulnerable adults. Dr. Amanda Cohn, who works for CDC and is a voting member of this FDA panel, made these comments.


AMANDA COHN: When I look at this question, it is pretty clear to me that the benefits do outweigh the risk when I hear about children who are being put in the ICU who are having long-term outcomes after their COVID and children are dying.

SIMMONS-DUFFIN: In the end, nearly all the advisers agreed that the benefits do outweigh the risks, including Dr. Hildreth, who explained why he voted yes after all.


HILDRETH: I want to make sure that the children who really need this vaccine, primarily the Black and brown children in our country, get the vaccine.

MCCAMMON: OK, but this isn't a done deal yet, right? I mean, where are we in this process?

SIMMONS-DUFFIN: Right. So now we're waiting for FDA, the agency itself. So it will likely agree with the advisory group - but we never know - and grant the emergency use authorization. Ideally, that would happen before early next week. That's when CDC's advisory panel meets to cast its vote and, last, CDC Director Rochelle Walensky gives the final green light. And that's when these pediatric shots would start to go out to pediatricians' offices and pharmacies. Experts say that will take a few days. So, you know, this step is done, but there are still a few more steps to come before kids would be able to start getting these vaccines.

MCCAMMON: NPR's Selena Simmons-Duffin, thank you.

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

NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

Selena Simmons-Duffin reports on health policy for NPR.