Pfizer, BioNTech Seek Authorization for COVID-19 Vaccinations in Teens

Pfizer and BioNTech have requested a revised Emergency Use Authorization for their COVID-19 vaccine, allowing its use in adolescents 12 to 15 years old.

Currently, the two-dose regimen is authorized by the FDA for individuals 16 years and older.

The move follows the drugmakers’ recent announcement that the vaccine demonstrated 100 percent efficacy in a phase 3 trial in 2,260 adolescents (DID, April 1).

The vaccine also elicited strong antibody responses and was well-tolerated, and all individuals in the study will be followed up with for two years after receiving their second dose, the companies said.

Pfizer and BioNTech said they plan to submit similar request to the European Medicines Agency and other global regulators “in coming days.”