FDA expected to authorize Pfizer-BioNTech booster shots for 12- to 15-year-olds by early next week

The Food and Drug Administration is expected by early next week to authorize booster shots of the Pfizer-BioNTech coronavirus vaccine for 12- to 15-year-olds, according to two people familiar with the FDA’s plan.

Some FDA officials had originally hoped to authorize a third dose of the Pfizer-BioNTech vaccine this week but faced scheduling challenges related to the holidays, according to the people with knowledge of the agency’s plan who spoke on the condition of anonymity to describe developing actions.

The FDA decision would then be reviewed by vaccine advisers at the Centers for Disease Control and Prevention, and that agency’s top official this week vowed to move quickly on recommending the booster shots if the CDC’s advisers concurred with FDA.

“Of course, the CDC will swiftly follow as soon as we hear from them, and I’m hoping to have that in the days to weeks ahead,” CDC Director Rochelle Walensky said Wednesday on CNN.

Federal officials, public health experts and a growing number of parents have raised concerns that younger adolescents have been left disproportionately vulnerable to the fast-spreading omicron variant compared with other populations.

[US children hospitalized with COVID in near-record numbers]

Older teenagers are already eligible for boosters, and younger children have more recently received their initial vaccine doses, which means they probably have retained more immune protection than children who were vaccinated earlier.

The omicron variant also has been linked to a rapid increase in pediatric hospitalizations this month.

The FDA’s plan was first reported by the New York Times.

The FDA declined to comment.

Pfizer referred questions about the timing of booster shot authorization to the agency.

“As the booster is already authorized for 16 and over, we are confident regulators are making every effort to look for ways to preserve a high level of protection against the virus across broad populations,” Jerica Pitts, a Pfizer spokeswoman, wrote in an email.

Biden administration officials have urged Americans to get booster shots to raise their immune protection against the omicron variant, which has been shown to evade antibodies conferred by prior infections or months-old vaccinations.

About 45% of the population age 18 and older has received a vaccine booster, White House coronavirus coordinator Jeffrey Zients said at a news briefing Wednesday.

“But as the doctors continually emphasize: Everybody who is eligible should go get boosted as soon as possible,” Zients added.

Expanding booster eligibility to more children would “be much welcomed news, but it will have limited impact on the current omicron surge,” said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. He has warned that the fast-spreading omicron variant will challenge the nation’s health system.

“By the time we could put in place vaccination locations and get kids scheduled, together with delayed improving immunity, [the omicron] surge is likely over,” Osterholm said.