U.S. FDA Authorizes mRNA COVID-19 Vaccine for Adolescents

The U.S. Food and Drug Administration 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 stated in a press release on May 10, 2021, it had amended the EUA originally issued on Dec. 11, 2020, for administration in individuals 16 years of age and older.

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA. This vaccine's known and potential benefits in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population. 

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D., in a media statement.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

From March 1, 2020, through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC).

Children and adolescents generally have a milder COVID-19 disease course as compared to adults.

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” commented Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“With science guiding our evaluation and decision-making process, the FDA can assure the public and the medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”

The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and 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 EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The issuance of a EUA is not an FDA Approval (licensure) of an experimental vaccine.