FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents
The U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.
The authorization caps weeks of anticipation among parents, who have been grappling with how to conduct their lives when only the adults in a household are immunized. It removes an obstacle to school reopenings by reducing the threat of transmission in classrooms, and affords millions of adolescents the opportunity to attend summer camps, sleepovers and get-togethers with friends.
The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.
The F.D.A.’s go-ahead is not the final hurdle. An advisory committee of the Centers for Disease Control and Prevention is expected to meet shortly to review the data and make recommendations for the vaccine’s use in 12- to 15-year-olds. If the committee endorses the vaccine for that age group, as expected, immunizations in theory could begin immediately. Clinical trials have shown that these children may safely receive the dose already available for adults.