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The FDA delays considering the Pfizer COVID vaccine for kids under age 5

ADRIAN FLORIDO, HOST:

In a surprise move, the Food and Drug Administration today postponed considering authorization for a pediatric version of the Pfizer-BioNTech COVID-19 vaccine for children under 5.

NPR health correspondent Rob Stein joins us now. Hi, Rob.

ROB STEIN, BYLINE: Hey there, Adrian.

FLORIDO: A lot of parents of very young children have been anxiously awaiting a vaccine for their kids, but now it looks like they're going to have to wait a little longer. What happened?

STEIN: Yeah, you know, this is another whiplash moment in the long, twisted road to getting a vaccine for kids younger than 5. The FDA announced it was delaying considering the vaccine for these kids to get more data. It's a huge surprise.

The FDA had scheduled a meeting of its outside advisers to consider the vaccine next Tuesday and was expected to release more details today. And the White House had even already started planning to ship the vaccine by the end of the month. But instead, the FDA suddenly put everything on hold again.

FLORIDO: Can you remind us what led up to this?

STEIN: Yeah, so, you know, the companies picked a very low dose for their vaccine for these really little kids to minimize the side effects. But right before Christmas, the companies announced that those two low dose shots only seemed to generate enough antibodies in kids ages 6 months old to 23 months old, not for those ages 2, 3 and 4. So the company started giving kids a third shot to see if that worked.

But last week, the FDA surprised everyone by taking the highly unusual step of asking the companies to apply for authorization for the two-shot regimen in the meantime. The idea was to get the ball rolling and let parents start vaccinating their kids so they'd be ready for that third shot when the data hopefully finally showed that it worked. That was unprecedented and raised a lot of eyebrows.

FLORIDO: And how did the FDA explain this turnaround?

STEIN: You know, the FDA says new data had recently emerged from the company's study that made the agency realize it needed to allow more time to see more evidence from that third dose. During a briefing for reporters, the FDA's Dr. Peter Marks said so many more kids are catching the virus because of the omicron overground surge that it was enabling the companies to collect more data more quickly, including data beyond just how good the vaccine is at producing antibodies.

(SOUNDBITE OF ARCHIVED RECORDING)

PETER MARKS: We realize now in data that came in very rapidly because of the large number of cases of omicron that at this time, it makes sense for us to wait until we have the data from the evaluation of a third dose before taking action.

STEIN: Pfizer says it should have that additional data by April.

FLORIDO: What's the reaction to this, Rob?

STEIN: Well, you know, it's not hard to imagine that a lot of parents are going to be really disappointed. You know, many had been feeling left behind and frustrated that they couldn't vaccinate their kids. And Dr. Marks talked about that today.

(SOUNDBITE OF ARCHIVED RECORDING)

MARKS: For those parents who really feel this, we empathize with them because I suspect that they're not only concerned about the current situation, even though there's a drop in cases, but they're concerned about future variants that could potentially come along.

STEIN: But, you know, many experts that I've been in touch with say they think this is probably a good move. It was kind of questionable to ask parents to give their kids two shots of a vaccine just in the hope that a third shot may work. But there is concern that all the back and forth may spook some parents. You know, it's already been hard to convince most parents to vaccinate even older kids.

Here's Dr. Celine Gounder, an infectious disease expert at New York University who has advised the administration.

CELINE GOUNDER: I just don't know anymore. I feel like they keep shooting themselves in the foot by making it so confusing.

STEIN: But, you know, Dr. Gounder stresses that she's confident that in the end, the FDA will only authorize a vaccine if it is safe and effective. But, you know, parents are just going to have to wait, you know, maybe a couple more months to find out whether that's going to be available for them for their younger kids.

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

STEIN: You bet. Transcript provided by NPR, Copyright NPR.

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