FDA Authorizes Pfizer-BioNTech Booster for 12- to 15-Year-Olds

U.S. health regulators cleared use of a Covid-19 booster from Pfizer Inc. PFE -3.38% and BioNTech SE BNTX -6.26% in adolescents 12 to 15 years old, expanding access to an extra dose that could bolster the fight against the Omicron variant.

The U.S. Food and Drug Administration permitted the additional doses to be given at least five months after the adolescents received their second shot. The agency also cleared boosters for certain children with compromised immune systems age 5 to 11.

Health authorities have been urging people to get a booster, citing early research indicating it is needed to maintain strong protection against Omicron.

The FDA has authorized the Pfizer-BioNTech booster for people as young as 16 years old.

Yet the agency hadn’t cleared the extra dose for younger adolescents, who have been able to get vaccinated for more than six months, the time when some studies indicate people’s antibody levels drop.