Mary Louise Kelly, American Academy Of Pediatrics, Lee Savio Beers discussed on All Things Considered
This is all things considered from NPR News. I'm Mary Louise Kelly in Washington and I'm Ailsa Chang in Los Angeles. 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. Thank you so much for having me here. Okay. 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? 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 A gin does de escalation. Where will then work backwards to younger and younger Children? And make sure that the vaccine and the doses that were giving are also safe and effective for younger Children? Because Children are not just like little adults? They there are real issues to figuring out how to vaccinate Children specifically. Yes, absolutely. Children are smaller. They have different physiology there at a different stage of their development, and we want to make sure that anything that we approved for them that's authorized for them is safe and effective. 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? So one of the things that we think about 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 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 way is the risk of the vaccine, um less than or greater than the risk of Covid infection. Two 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. 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? Our understanding from what we're hearing from the clinical trial sites and from the manufacturers is that their trials are are fully enrolled in that 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, um the safety and effectiveness of the vaccine and consider the risk benefit for Children. Okay, but the FDA wants Six months of data. Why is that? Can you explain that discrepancy? And how important is that discrepancy? Yes, absolutely, You know, And this is actually something that we've seen with the emergency use authorization of the vaccine and 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 that they could rely on the very strong safety data at two months, and the final approval came at six months, which is which is an important landmark. But but a cautious one and we we really believe that the same situation applies for Children. So we absolutely believe that that we have Enough data to determine the safety and efficacy of the vaccine for emergency use authorization in Children after two months. I'm curious because 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. We are hearing from pediatricians across the country that parents are interested in receiving the FDA vaccine. What we can call off label for their younger Children. We don't recommend that at the AP, and nor does the FDA or the C D. C 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. Lee Sabio Beers is a pediatrician and the president of the American Academy of Pediatrics. Thank you very much for joining us today. Well, thank you so much for having me here to help grasp day to day life in Afghanistan and how it's changing. One of the people we've been checking in with is Felipe Ribeiro. He runs the Afghanistan office of Doctors without Borders. First spoke with him on August 6th nine days before Kabul fell to the Taliban. And then he was describing the situation in Lashkargah, one of the cities where his medical teams operate as horrific daily bombings burn and shrapnel wounds, stray bullets flying around the hospital compound. When we checked back August 19th. It was a different scene. Much calmer. The Lashkar Gah hospital was full, but not all war injuries. They were delivering healthy babies again. Well, we have asked fully pay Ribeiro back to hear how it's going. Now that the U. S military is gone, and the Taliban have announced an interim government Hi there Good to speak with you again. Hello. Good to speak. You too. Tell me about Lashkar Gar and how it's going now. This is southern Afghanistan. What does your team say? How are they describing the situation today? The situation is very common in the south. I mean, it's basically very calm all over the place in English car guard but also in the rest of the country..