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Today, the 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 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. “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. 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.
Additional Resources:
 The FDA is scheduled to hold a virtual press conference to discuss the authorization of the Pfizer COVID-19 vaccine for use in adolescents.
As part of the FDA’s commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDA’s YouTube page. Acting FDA Commissioner, Janet Woodcock, M.D., and Director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D. will be taking questions.
When: Mon., May 10, 7 p.m. ET
The FDA's Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast.
During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
About Us
The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders. We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living.
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