Pfizer submits data on children’s COVID vaccine

(Gray News) - Pfizer and BioNTech announced Tuesday that the companies have submitted COVID-19 vaccine testing data to the Food and Drug Administration in hopes of getting approval for use on children 5-11 years old.

The companies said they received positive results from the trial on Sept. 20, which included 2,268 young participants.

Pfizer said the vaccine “demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen.”

For now, Pfizer’s vaccine is only approved for use in people 12 and older, though the companies will make a formal request for an emergency use authorization for use in children in the coming weeks.

The FDA is expected to take several weeks combing through the data before possibly issuing an emergency use authorization.

According to the American Academy of Pediatrics, more than a quarter of all COVID-19 cases reported nationwide are now in children, increasing the urgency to get kids protected.

“I wouldn’t be so cavalier about this virus. We know that this virus has long-term consequences in a lot of people who contract it, including children,” said Dr. Scott Gottlieb, a former FDA commissioner.

Even when a vaccine becomes available, a difficult task lies ahead in getting children vaccinated.

Less than half of eligible U.S. adolescents are fully vaccinated against COVID-19, according to an analysis of CDC data. They’ve been eligible since May.