American Academy of Pediatrics urges FDA to approve COVID vaccines for children under 12

As the U.S. continues inoculating adults and adolescents, questions remain about vaccinating the 48 million kids under the age of 12. With the delta variant raging, almost five times as many children are being hospitalized for COVID-19. The American Academy of Pediatrics has called on the FDA to pick up the pace. William Brangham discusses with Dr. Lee Beers, president of the academy.

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  • Judy Woodruff:

    The Biden administration rolled out new mandates last week to expand vaccination for more than 100 million more Americans.

    But questions remain about when one major population ineligible for the shot, and that is kids under the age of 12, will be able to get it.

    William Brangham looks at those concerns.

  • William Brangham:

    Judy, there are 48 million kids in America under the age of 12, but the timeline for a vaccine for those kids keeps changing.

    This summer, the FDA went back to manufacturers asking for expanded trials and more data. It's not clear when emergency authorization will actually happen. But with the Delta variant raging, almost five times as many children are now being hospitalized for COVID-19.

    The American Academy of Pediatrics has called on the FDA to pick up the pace.

    We talk now to Dr. Lee Beers. She is president of the Academy and also a pediatrician.

    Dr. Beers, great to have you on the "NewsHour."

    You wrote this letter on behalf of the Academy to the FDA saying, we have got to move quicker.

    Make the case. Why do you think that they need to speed up the process?

    Dr. Lee Beers, American Academy of Pediatrics: For any vaccine, medication, any kind of medical intervention, one of the things we always think about is the risk/benefit.

    And we need to make sure that the benefit of the vaccine or the medication or the therapeutic outweighs — the risk of that outweighs the risk of the illness. And what we have been seeing with COVID, we know, thankfully, COVID tends to be very mild in children, but some children can still get very sick. But low risk is not zero risk.

    And what we have seen with Delta is that Delta is so much more contagious that we're seeing many, many more children get sick. I often say a small percentage of a large number of children is a really large number of children.

    So, right now, we're seeing children get very sick. We see it in the numbers. We also see it in our pediatricians' offices, where we're hearing from pediatrician offices and hospitals all across the country that they're — that they're overwhelmed.

    And so, in our mind, actually, we have always thought that the vaccine is a really important tool in the toolbox for — to keep our youngest kids healthy. But now it's really getting particularly acute and particularly urgent.

  • William Brangham:

    In the letter that you all wrote to the FDA, you said that, if after two months of data, it looks like it's a viable vaccine for kids, let's approve it, vs. the six months that they seem to want.

    Can you explain the difference there?

  • Dr. Lee Beers:

    I think this is something, actually, that we all maybe have gotten familiar with in the final approval of the vaccine for adults.

    Emergency use authorization was given after two months and final approval after six months. And what we know from vaccine science and vaccine development really across the past 70 years is that we really — for a virus that's not a live virus, like this one is not, we have never seen a side effect that has occurred after the first six to eight weeks.

    So, we feel quite comfortable, actually, that a two-month monitoring period is adequate for making this decision about whether the vaccine is safe and effective. And we know that the Delta variant really is quite contagious. And so we're seeing a lot of kids get sick right now.

    And so those two things together really tell us that we feel like a two-month period is adequate.

  • William Brangham:

    We have seen some very rare complications with young — younger adults, younger males in particular, this myocarditis, the inflammation of the muscles of the heart.

    Do you worry, though, that, even if after two months, we don't — the FDA doesn't see anything really problematic, that there still might be some of those cases in children, and sick children, because of a vaccine in a hospital becomes wildfire in this media ecosystem that we live in, and that that could do much greater damage to the vaccine effort more broadly?

    Is that a fear that you have?

  • Dr. Lee Beers:

    It's a really important question, right, because we do want to be cautious.

    That's part of why we have these very structured and deliberate systems in place to make sure that our vaccines are safe. The one thing I always like to remind people is the fact that we're even having this discussion about a side effect that really is quite rare tells us that our vaccine monitoring systems are working the way they should.

    Of course, we take every side effect seriously. And what we have seen with the cases of myocarditis after the vaccine is that almost exclusively they are quite mild and do resolve their own.

    What we also know is that getting infected with COVID can cause myocarditis as well. And what we're seeing in those cases is that the risk of myocarditis with COVID infection is much greater than the risk that we're seeing with the vaccine and also the risk of myocarditis — or that the myocarditis that happens in kids after a covered infection can be much more severe.

  • William Brangham:

    We have seen some anecdotal reports of parents getting so-called off-label vaccinations for their children for COVID-19, I guess through doctors or clinics that are willing to do that.

    You guys have also been counseling against that as well.

  • Dr. Lee Beers:

    Yes, that's absolutely correct.

    Our FDA processes are in place for a reason. We want to make sure that we can be confident in our vaccine safety. And so it's really important to follow those processes.

    The also other pieces that we know from the clinical trials that actually the dosage in younger children of the vaccine is likely to be smaller. And so we really don't want children getting off-label vaccines. But it's — we want to make sure that the vaccine, when they get it, it's authorized and it's safe and effective.

  • William Brangham:

    All right, Dr. Lee Beers, president of the American Academy of Pediatrics, thank you so much for being here.

  • Dr. Lee Beers:

    Thank you so much for having me.

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