FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15
By edhat staff
Today, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include adolescents 12 through 15 years of age.
The FDA amended the emergency use authorization originally issued on Dec. 11, 2020, for administration in individuals 16 years of age and older.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D.
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. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older, according to the news release.
The FDA determined the vaccine has met the statutory criteria to amend the emergency authorization, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.
“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,” said 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 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 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.
Read the complete news release here.