On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. On May 10, 2021, the FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
- Emergency Use Authorization Status:
- Pfizer-BioNTech COVID-19 Vaccine
- Pfizer Inc.
For the prevention of 2019 coronavirus disease (COVID-19) for individuals 12 years of age and older
Common Side Effects
The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. Learn more.
|Letter of Authorization||English|
|Letter Granting EUA Amendment (01/06/2021)||English|
|Letter Granting EUA Amendment (01/22/2021)||English|
|Letter Granting EUA Amendment (04/06/2021)||English|
|Fact Sheet for Healthcare Providers Administering Vaccine||English|
|Fact Sheet for Recipients and Caregivers||English|
|FDA Decision Memorandum||English|
|Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine||English|
|Press Release (12/11/2020)||English|
|Press Release (05/10/2021)||English|
|12/10/2020 Advisory Committee Meeting Information||English|
Translations of the Fact Sheet for Recipients and Caregivers