FDA Lowers Age Range for Pfizer Booster Shot

Adolescents ages 12-15 can now get a booster dose of Pfizer/BioNTech’s COVID-19 vaccine (Comirnaty) under emergency use authorization (EUA), the FDA said on Monday.

The agency also changed the interval for boosters shots of Pfizer’s vaccine in all individuals 12 and up to at least 5 months after the second dose (was previously 6 months), and allowed a third dose for certain immunocompromised children ages 5-11 at least 28 days after their two-dose primary series.

This comes about a month after the agency authorized a single-dose booster for teens ages 16 and 17.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research in a statement.

FDA cited real-world Israeli data from 6,300 individuals ages 12-15 who received a booster dose at least 5 months after their primary series, and no new safety concerns from a population of 4.1 million individuals in Israel ages 16 and up who have received booster doses.

Once again, the agency did not convene the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to support this decision.

The agency added that the “known and potential benefits” of a booster dose at 5 months “outweigh the known and potential risks.”

FDA also authorized a third dose of Pfizer’s vaccine for children ages 5-11 who underwent solid organ transplant or have another immunocompromising condition and who “may not respond adequately to the two-dose primary vaccination series.” Third doses are not authorized for all other children in this age group, the agency noted.

CDC’s Advisory Committee on Immunization Practices (ACIP), which was not convened when the EUA was expanded to 16- and 17-year-olds, is expected to convene later this week to discuss booster recommendations for this population, according to media reports.