FDA Says Vaccines For Kids Under 12 Expected By Midwinter

Emergency approval for Covid-19 vaccines in children under 12 could come in early to midwinter, a Food and Drug Administration (FDA) official said Thursday. The move could bring relief to many parents who have been unable to vaccinate their children. The agency hopes to then move quickly to full approval of the vaccine for this age group.

One sticking point for some families who remain hesitant, the official said, is that the vaccines currently in use are administered under emergency use authorization and have not been given full approval by the FDA. Full approval, if it comes quickly after the emergency round, could alleviate that concern. Covid-19 vaccines have only been authorized for people ages 12 and up in the U.S., and none has received full approval yet.

Both Moderna and Pfizer-BioNTech launched trials of their Covid-19 vaccines for kids under 12 in March. Results are expected in the fall, and it will take FDA officials time to review the drug companies’ applications. The agency is asking for four to six months of safety follow-up data for kids under age 12, the FDA official said. Just two months of follow-up data were required for the clinical trials in adults, which could make the process of granting full approval easier.

So far, only Pfizer-BioNTech has applied for full licensure of its vaccine for adults 18 and up. The FDA official said granting full approval for adults is the agency’s highest priority. Pfizer said in a statement that it anticipates results on its clinical trials in kids ages 5 to 11 sometime in September and then could apply for emergency use authorization. “Data for kids 2 and under 5 could arrive soon after that,” the company said, adding that results on kids ages 6 months up to 2 years may not be released until October or November.

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— Acyn (@Acyn) July 15, 2021

Dr. Buddy Creech, one of the primary researchers for the Moderna KidCOVE clinical trials, which includes children as young as 6 months, predicted a rollout of pediatric data similar to Pfizer’s.

“I can’t imagine, except maybe for the 6- to 11-year-olds, that we’re going to have too much data before the late fall,” Creech, also a pediatric infectious disease expert and director of the Vanderbilt Vaccine Research Program at the Vanderbilt University Medical Center in Nashville, Tennessee, said. Results on kids 5 years old and younger may take longer, he added. “There is still a lot of work left to be done.”