ARI SHAPIRO, HOST:
Pfizer and BioNTech have announced good results from a trial of their COVID-19 vaccines in children aged 5 to 11 years old. They now plan to submit their findings to the FDA for review. There's been a surge in cases among children and a shaky start to a school year, with millions of unvaccinated kids back in the classroom.
NPR's Allison Aubrey joins us with the latest.
Hi, Allison.
ALLISON AUBREY, BYLINE: Good to be here, Ari.
SHAPIRO: Tell us what Pfizer and BioNTech are saying about the results of these trials.
AUBREY: The companies say the vaccine was safe, it was well tolerated, and it triggered a strong immune response. The children in the trial got a smaller dose, about a third of what's given to adults and older children, and the vaccine makers say the side effects are about the same as those seen in teens and young adults, such as a sore arm or muscle aches. In a statement from Pfizer today, Albert Bourla, the chairman and CEO of the company, said the trial results provide a foundation for seeking authorization of the vaccine for children 5 to 11 years old, and the company plans to submit them to the FDA with urgency, he said.
SHAPIRO: A foundation for seeking authorization - so what are the next steps to getting authorization?
AUBREY: Well, the FDA officials have said that they will let the data guide them here, and they hope to have pediatric COVID-19 vaccines available in the coming months, they say. I spoke to David Kimberlin, a pediatric infectious disease doctor at the University of Alabama at Birmingham. He also serves as a liaison from the American Academy of Pediatrics to the CDC's advisory committee. Here he is.
DAVID KIMBERLIN: Now, of course, it has to be authorized by the Food and Drug Administration first, and then it has to be recommended for use by the CDC's Advisory Committee on Immunization Practices. And it appears to me now that we're back on track for an October, maybe even mid to late October recommendation.
AUBREY: He says it's a very fluid situation, but certainly the FDA receiving data from Pfizer sets the process in motion.
SHAPIRO: And there's time pressure to get this done quickly, right? Haven't pediatricians been urging the FDA to move as fast as possible?
AUBREY: That's right. Both Pfizer and Moderna expanded their clinical trials in children, and this was done to ensure they could pick up on rare adverse events. Now these trials are ongoing. But back in August, as the delta variant fueled the surge in cases among children, the American Academy of Pediatrics said that delta had kind of changed the equation. Given the urgency, the group said the FDA should strongly consider authorizing vaccines based on data from the initial cohort, or the initial group of children. So, you know, there's some tension, Ari, between wanting to inoculate children against the virus as soon as possible, but also to make sure that the vaccine is safe and that the benefits do outweigh the risks. Dr. Kimberlin says the process is working, and advisers to the FDA will weigh in, and they will speak up if they see any concerns as they review the data.
KIMBERLIN: Parents can be, you know, really confident - if the authorization is made and the recommendation is made, they can be really confident that it was done right, that it was based on the data, that it was based on science.
AUBREY: And this comes amid a surge in cases in kids.
SHAPIRO: Not only a surge in cases, but also child hospitalizations are up, right?
AUBREY: That's right. I mean, most cases among kids are mild, but many pediatric clinics and ERs are full, especially in states that have been hardest hit by this surge. There are just so many cases among kids right now, Dr. Kimberlin says.
KIMBERLIN: A quarter of a million children every week over the last, you know, couple or three weeks being diagnosed with COVID - these are outpatient and inpatient, of course. But those numbers are unprecedented.
SHAPIRO: So that's the latest on vaccine shots for children. What about news that we might get this week on booster shots for adults? What's the latest there?
AUBREY: Sure. Well, the FDA is expected to announce a decision any time now, really, Ari, on a Pfizer booster. CDC advisers voted late last week in favor of boosters for people 65 and up and those at high risk. Now, the agency typically follows the advisers' guidance here, and the CDC's Advisory Committee on Immunization Practices is scheduled to meet this Wednesday. So we could hear a decision very soon, Ari.
SHAPIRO: That's NPR's Allison Aubrey with the latest on coronavirus vaccines.
Thanks, Allison.
AUBREY: Thank you, Ari. Transcript provided by NPR, Copyright NPR.
