FDA authorizes Pfizer-BioNTech booster shots for older adolescents

The FDA on Thursday authorized booster doses of the Pfizer-BioNTech COVID-19 vaccine for children aged 16 and 17 years.

The amended emergency use authorization — which makes third doses of the vaccine available to older adolescents at least 6 months after their primary series — came 3 weeks after the FDA authorized booster shots of the Pfizer-BioNTech and Moderna vaccines for all adults.

“The Pfizer-BioNTech COVID-19 vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

Pfizer and BioNTech said this week that laboratory tests showed the vaccine “may not” offer sufficient protection against the omicron variant of SARS-CoV-2 but that a third dose neutralized the variant at levels comparable to two doses against the original virus strain.

“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group,” Marks said. “A single booster dose of the vaccine for those vaccinated at least 6 months prior will help provide continued protection against COVID-19 in this and older age groups.”

Older adults and others at high risk have been eligible for COVID-19 booster shots since September. Back then, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted not to issue a blanket recommendation for booster shots for everyone aged 16 years or older. Thursday’s authorization was not preceded by a meeting of the VRBPAC because, the FDA said, “the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of Pfizer’s EUA request, the FDA concluded that the request does not raise questions that would benefit from additional discussion by committee members.”

CDC Director Rochelle P. Walensky MD, MPH, signed off on recommending boosters for 16- and 17-year-olds — also without convening a meeting of her advisory committee, the Advisory Committee on Immunization Practices.

“CDC is strengthening its booster recommendations and encouraging everyone 16 and older to receive a booster shot,” Walensky said in a statement. “Although we don’t have all the answers on the omicron variant, initial data suggest that COVID-19 boosters help broaden and strengthen the protection against omicron and other variants. We know that COVID-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least 6 months post their initial Pfizer vaccination series.”

Acting FDA Commissioner Janet Woodcock, MD, said the news was welcome in anticipation of the winter holidays.

“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Woodcock said in the release. “With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”