Pfizer-BioNTech COVID-19 Vaccine
August 18, 2021: FDA supports the Administration’s work to plan for the deployment of additional vaccine doses, or boosters, this fall. FDA will undertake an independent scientific evaluation of the safety and effectiveness of boosters for each vaccine. View joint statement.
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. On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. On August 12, 2021, the FDA amended the Pfizer-BioNTech COVID-19 Vaccine EUA to allow for an additional dose to be given to certain immunocompromised individuals. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
- Emergency Use Authorization Status:
- Authorized
- Name:
- Pfizer-BioNTech COVID-19 Vaccine
- Manufacturer:
- Pfizer Inc.
Authorized Use
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.
Fact Sheets (English) and FAQs
| Information | Last Updated |
|---|---|
| Fact Sheet for Healthcare Providers Administering Vaccine | August 12, 2021 |
| Fact Sheet for Recipients and Caregivers | August 12, 2021 |
| Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine | August 12, 2021 |
Regulatory Information
| Information | Date |
|---|---|
| Letter of Authorization (Reissued) | August 12, 2021 |
| Decision Memorandum | August 12, 2021 |
| Letter Granting EUA Amendment | May 19, 2021 |
| FDA Decision Memorandum | May 10, 2021 |
| Letter Granting EUA Amendment | April 6, 2021 |
| Letter Granting EUA Amendment | January 22, 2021 |
| Letter Granting EUA Amendment | January 6, 2021 |
| FDA Decision Memorandum | December 11, 2020 |
| Advisory Committee Meeting Information | December 10, 2020 |
Media Materials and Webcasts
| Information | Date |
|---|---|
| Press Release | August 12, 2021 |
| FDA In Brief | May 19, 2021 |
| Press Release | May 10, 2021 |
| Press Conference | May 10, 2021 |
| Press Release | February 25, 2021 |
| Press Release | December 11, 2020 |
| Press Conference | December 11, 2020 |
| Advisory Committee Webcast | December 10, 2020 |
Translations of the Fact Sheet for Recipients and Caregivers