FDA to Decide Whether to Extend Pfizer’s COVID-19 Vaccine EUA to Young Children

Pfizer and BioNTech have filed for FDA authorization of their COVID-19 vaccine for inoculating children aged five to 11 years and the agency’s vaccine advisory panel will take up the matter at its previously scheduled meeting on Oct. 26 to consider the request.

The companies jointly announced early yesterday via Twitter that they are seeking the extended Emergency Use Authorization, citing the need to stem ever-increasing COVID-19 infections among young children.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort,” the companies said.

According to the American Academy of Pediatrics (AAP), children younger than 18 years have thus far comprised 16.2 percent of the total cases. But for the week ending Sept. 30, children made up 26.7 percent of reported weekly COVID-19 cases.

“As of Sept. 30, nearly 5.9 million children have tested positive for COVID-19 since the onset of the pandemic,” the AAP said, adding that the “number of new child COVID cases remains exceptionally high.”

Pfizer is submitting favorable topline data from its recently announced phase 2/3 study of 4,600 children aged six months to 11 years. The study included 2,268 children aged five to 11 years, who received a two-dose regimen of 10 micrograms, 21 days apart. The vaccine showed a “favorable safety profile” and strong immunologic response in the group, the company said.

“The antibody responses in the participants … were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30-microgram doses. The 10-microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children five to 11 years of age.,” Pfizer said, adding that “these are the first results from a pivotal trial of a COVID-19 vaccine in this age group.”

Last month, the FDA’s Vaccines and Related Biological Products Advisory Committee rejected recommending the agency’s approval of a booster dose of the Pfizer vaccine for the general population who have already received the two-dose inoculation  (DID, Sept. 20). — Michele G. Sullivan