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FDA to share data on how effective the Pfizer vaccine is for kids under 5


Parents of young kids waiting for a vaccine, it's getting closer. Today we will all find out how well the Pfizer-BioNTech COVID-19 vaccine works in children 6 months to 4 years old. NPR has learned that the companies have gathered additional data to support their request for this authorization. The Food and Drug Administration is expected to release that data today.

We've got NPR health correspondent Rob Stein with us. Hey, Rob.


MARTIN: I know friends of mine with young kids have felt so left out of all the celebration of the vaccines. They're just living like they did in 2020 because their children haven't yet been able to be vaccinated. So we're getting closer?

STEIN: Yeah. Yeah. You know, that's right. The vaccine so far had only been authorized for kids ages 5 and older. So, you know, like you said, lots of parents of those younger kids have been kind of holding their breath waiting for when they might finally be able to vaccinate their kids, too. But then Pfizer and BioNTech discovered that two shots of a low-dose version of their vaccine only seem to work in kids ages 6 months to 23 months old. It did not look like it would protect those ages 2, 3 and 4. So the company started giving kids a third shot to see if that would do the trick. The results from that third shot aren't due until next month, so everyone thought we'd have to keep waiting.


STEIN: But then last week, the FDA and the company surprised everyone. The FDA asked the companies to apply for authorization for the vaccine anyway. The idea is that parents could start vaccinating their kids so they'll be ready for that third shot when the data hopefully shows that it works.

MARTIN: But that seems unusual, right? They're asking for approval for a vaccine series before they know if it is actually effective.

STEIN: Yeah. Yeah. That's right. You know, it's a really unorthodox strategy - maybe unprecedented, you know, to say the least. And it's triggered a big debate about whether this is really the way to do this. So lots of people are waiting to get a better look at the evidence that companies have to, you know - about whether to go this way.

MARTIN: Yeah. So what is this additional data?

STEIN: The companies continued gathering data about the kids who had just gotten the two shots, including through when the omicron variant surged and lots of kids caught the virus. Now, that's obviously bad for all the kids who got sick, but it gave the companies and the FDA a chance to get a glimpse at whether the two-dose low-dose vaccine might be protecting kids. And according to someone familiar with at least an early look at that data, it suggests the vaccine may cut the risk of getting sick from the virus by about half. Now, there are some big caveats about all this. One is that it's based on kids who got infected at the end of the delta surge and in the beginning of the omicron surge. So it's unclear how well it really works against omicron, which is what really matters, obviously, at this point. And there just may not be enough evidence to really know how strong that protection is.

MARTIN: So considering the fast track of all this, what's been the reaction?

STEIN: Yeah. It's really mixed. You know, on the one hand, some are saying, you know, this strategy makes sense because, you know, the supercontagious omicron variant is still spreading fast, and some kids are still getting really sick. We're in a pandemic. So extraordinary times call for extraordinary measures. And it looks like the vaccine is very safe. Others say, hold on a minute here. You really want parents to give their kids two shots of a vaccine that may or may not work when the omicron surge is fading fast? And this could backfire, you know, by spooking parents by taking this approach. So it's already been really hard to convince many parents to vaccinate their kids.

MARTIN: So the next thing we should look towards is this big meeting Tuesday?

STEIN: Yeah. Tuesday these outside FDA advisers are going to get together, and they're going to review all the data. And in anticipation of that, the FDA is expected to release the details of the company's data today, along with the FDA's analysis. So we should get a better look at how strong the case really is later today. And if those FDA advisers are satisfied and the agency authorizes the vaccine...


STEIN: ...An independent CDC committee will then vote whether or not to recommend it.

MARTIN: Rob Stein, we appreciate it.

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

Rachel Martin is a host of Morning Edition, as well as NPR's morning news podcast Up First.
Rob Stein is a correspondent and senior editor on NPR's science desk.

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