AILSA CHANG, HOST:
You have heard a lot about booster shots lately. Are they needed? When will they be approved? And who will actually get them? But there are still tens of millions of people in this country who aren't even eligible for a first vaccine shot. We're talking about children 11 years old and younger. The vaccine still is not authorized for them. And Dr. Francis Collins, the director of the National Institutes of Health, told NPR last month that he doesn't see a vaccine for kids coming before the end of this year. That timeline has prompted organizations like the American Academy of Pediatrics to urge the Food and Drug Administration to accelerate its authorization process.
Lee Savio Beers is a pediatrician and the president of the American Academy of Pediatrics. She joins us now. Welcome.
LEE SAVIO BEERS: Thank you so much for having me here.
CHANG: OK, so before we get to this letter that you wrote, which urged the FDA to speed up approval of the vaccine for children, can you just explain very briefly for us, why is this taking so long in the first place?
SAVIO BEERS: So I think one of the most important things to emphasize here is that the FDA authorization and approval process really is in place to make sure that when vaccines or any therapeutics, actually, are available, that they're safe and effective. And what we know in vaccine development for children is that we are appropriately more cautious. Typically, vaccine development will start with adults, and then we do what's called age and dose deescalation, where we'll then work backwards to younger and younger children and make sure that the vaccine and the doses that we're giving are also safe and effective for younger children.
CHANG: Right - 'cause children are not just, like, little adults. There are real issues to figuring out how to vaccinate children specifically.
SAVIO BEERS: Yes, absolutely. Children are smaller. They have different physiology. They're at a different stage of their development. And we want to make sure that anything that we approve for them that's authorized for them is safe and effective.
CHANG: Well, then let's turn to the letter that you wrote to the FDA. In this letter, you say that, quote, "in our view, the rise of the delta variant changes the risk-benefit analysis for authorizing vaccines in children."
Can you explain, what is that risk-benefit analysis in general?
SAVIO BEERS: So one of the things that we think about, you know, every vaccine, every medication has a potential side effect. And so does the risk outweigh the important benefit that this particular therapeutic can bring? So, for example, we know that COVID-19 can be an incredibly serious illness, so it's important to make sure that we protect against that. Now, we also know that for younger children, the risk of severe COVID infection is less. And so what we have to do is weigh, is the risk of the vaccine less than or greater than the risk of COVID infection to children? And I think it's very clear to us that the risk of COVID in children far outweighs any potential risk of the vaccine.
CHANG: And just to be clear, in this letter that you wrote, you argue that the FDA will have, very soon, the data it will need to authorize the vaccine for children, right? Can you just explain, what is that data that the FDA will have quite soon?
SAVIO BEERS: Our understanding from what we're hearing from the clinical trial sites and from the manufacturers is that their trials are fully enrolled and that the - at least one of the manufacturers expects to have data available to submit to the FDA, hopefully by the end of September, perhaps early in October. And so what that means is that once that data is submitted, the FDA will have a chance to look at it to determine the safety and effectiveness of the vaccine and consider the risk-benefit for children.
CHANG: OK, but the FDA wants six months of data. Why is that? Can you explain that discrepancy? And how important is that discrepancy?
SAVIO BEERS: Yes, absolutely. You know, and this is actually something that we've seen with the emergency use authorization of the vaccine in adults. The emergency use authorization came after two months because the FDA really felt and believed that the benefit of approving the vaccine because of the public health emergency was great enough that they could rely on the very strong safety data at two months. And the final approval came at six months, which is an important landmark but a cautious one. And we really believe that the same situation applies for children. So we absolutely believe that we have enough data to determine the safety and efficacy of the vaccine for emergency use authorization in children after two months.
CHANG: I'm curious 'cause you're a pediatrician. Are you seeing parents coming into your office and asking you to go ahead and just vaccinate their children, regardless of what the FDA eventually decides?
SAVIO BEERS: We are hearing from pediatricians across the country that parents are interested in receiving the FDA vaccine what we call off-label for their younger children. We don't recommend that at the AAP and nor does the FDA or the CDC. And the reason for that is that it is important to look at the data from the trials. It is important to make sure that we have approved and authorized the right, safe and effective dose for children. And what we know of the trials is that the dose for younger children is likely to be less than that for - of adults.
CHANG: Lee Savio Beers is a pediatrician and the president of the American Academy of Pediatrics.
Thank you very much for joining us today.
SAVIO BEERS: Well, thank you so much for having me here. Transcript provided by NPR, Copyright NPR.
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