FDA Expected to Clear Pfizer Boosters for 12-15-Year-Olds Monday

(Reuters) -
Brendan Lo (13) receives a dose of the Pfizer-BioNTech vaccine in New Hyde Park, New York. (REUTERS/Shannon Stapleton/File Photo)

The Food and Drug Administration plans on Monday to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for 12- to 15-year-olds, the New York Times reported on Thursday, citing people familiar with FDA deliberations.

U.S. regulators also plan to cut the time gap for both adolescents and adults to get a booster shot of Pfizer’s vaccine to five months after a second dose, from the current six months, the newspaper reported.

The FDA declined to comment on the report.

A booster dose for 12- to 15-year-olds could be an important tool for millions of children in the face of rising cases fueled by Omicron. The variant is able to evade some of the protection offered by two doses of the Pfizer-BioNTech vaccine, according to early data from lab studies.

But booster doses of the Pfizer-BioNTech and Moderna vaccines appear to be protective against Omicron, also according to lab studies.

The rapidly spreading variant has led to thousands of new COVID-19 hospitalizations among U.S. children in recent weeks, raising new concerns about how the many unvaccinated Americans under the age of 18 will fare in the new surge.

U.S. Centers for Disease Control and Prevention director Rochelle Walensky, in an interview with CNN on Wednesday, said the agency could take a call on the third COVID-19 vaccine dose for children aged 12-15 “in the days to weeks ahead”.

NYT reported that the CDC’s vaccine advisory committee plans to meet by the middle of next week to vote on whether to recommend the changes.

While U.S. officials have said vaccinations protect against serious illness and death from Omicron, some children aged 12-15 are now more than six months out from their earlier inoculations.