FDA official hopeful younger kids can get shots this year

The Food and Drug Administration’s vaccine chief said Friday the agency will rapidly evaluate COVID-19 vaccinations for younger children as soon as it gets the needed data — and won't cut corners.

Dr. Peter Marks told The Associated Press he is “very, very hopeful” that vaccinations for 5- to 11-year-olds will be underway by year’s end. Maybe sooner: One company, Pfizer, is expected to turn over its study results by the end of September, and Marks say the agency hopefully could analyze them “in a matter of weeks.”

In the U.S., anyone 12 and older is eligible for COVID-19 vaccines. But with schools reopening and the delta variant causing more infections among kids, many parents are anxiously wondering when younger children can get the shots.

Pfizer’s German partner BioNTech told weekly Der Spiegel Friday that it was on track “in the coming weeks” to seek approval of the companies' COVID-19 vaccine for 5- to 11-year-olds. Moderna, which makes a second U.S. vaccine, told investors this week to expect its data on that age group by year’s end. Both companies also are testing their vaccines down to age 6 months, but those results will come later.

FDA’s Marks spoke with the AP Friday about the steps involved in clearing pediatric vaccines. The conversation has been edited for clarity and length.

Q: Many parents had hoped for vaccines for children under 12 by the time schools reopened. Why is it taking so long?

A: Before you can actually approve something in an age range, you actually have to study in that age range. ... Children under the age of 12, they’re not little adults, they’re not. And so one does actually have to study this and even change perhaps the dose that’s being given — and in fact, that’s had to happen, change the dose.

We have to then be able to look at the...