16- And 17-Year-Olds Are Now Eligible for Pfizer COVID-19 Booster

Federal regulators on Thursday authorized and recommended the Pfizer-BioNTech’s COVID-19 booster shot for 16- and 17-year-olds.

The decision came a day after Pfizer released new data indicating that booster shots may be critical for bolstering the level of virus-fighting antibodies necessary to ward off the Omicron variant. Officials from the Food and Drug Administration (FDA) said that increasing the uptake of booster shots can help minimize the spread of the Delta and Omicron variants during the upcoming holidays.

“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a statement.

As with adults, 16- and 17-year-olds can receive a booster shot of the Pfizer vaccine six months or more after the second dose. The Moderna and Johnson & Johnson boosters are not yet authorized for people younger than 18.

“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups,” he added.

The FDA weighed the safety and efficacy of a single booster shot based on a clinical study including about 200 participants aged 18 to 55, as well as real-world data. The agency said that based on the data presented by Pfizer, the benefits of expanding booster eligibility to 16- and 17-year-olds outweigh the risk of adverse outcomes like myocarditis, or heart inflammation.

The FDA did not hold a meeting of its advisory committee to discuss the decision, saying it had already extensively reviewed data on boosters when it authorized the shots for all U.S. adults in November. Pfizer’s request for Emergency Use Authorization did “not raise questions that would benefit from additional discussion by committee members," the FDA said.

With rising cases of the Omicron variant, the Centers for Disease Control and Prevention strengthened its language on booster recommendations, saying that all eligible adults should get a booster shot.

About 56% of Americans aged 16-17 are fully vaccinated against COVID-19. About 30% of this age group, or 2.5 million people, finished their primary series six months ago and now eligible to receive a booster.

"Although we don’t have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants," CDC Director Rochelle Walensky said in a statement. "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 six months post their initial Pfizer vaccination series."