A Message from EEOC Chair Charlotte A. Burrows for Transgender Day of Remembrance (November 20, 2021)
November 20, 2021HEALTHCARE EMPLOYERS
December 22, 2021On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 12 years of age and older at least five months after completing a primary series of the vaccine.
The Pfizer-BioNTech COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Moderna and Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.
On February 11, 2022, in consultation with FDA, CDC updated the emergency use instructions to provide information about the primary, additional, and booster doses of the Pfizer COVID-19 vaccines in certain individuals.
Comirnaty Information
| Information | Last Updated |
|---|---|
| Package Insert (purple cap) | December 2021 |
| Package Insert (gray cap) | December 2021 |
| Approval Letter | August 23, 2021 |
| Supplement Approval Letter | December 16, 2021 |
| Summary Basis for Regulatory Action | November 8, 2021 |
| FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español) | February 2, 2022 |
| CDC-issued Emergency Use Instructions (updated) | February 11, 2022 |
Pfizer-BioNTech Fact Sheets (English) and FAQs
| Fact Sheet / FAQs | Vaccine Recipient Group | Last Updated |
|---|---|---|
| For Healthcare Providers | 12 years of age and older, purple cap (must dilute) | January 31, 2022 |
| For Healthcare Providers | 12 years of age and older, gray cap (no dilution) | January 31, 2022 |
| For Healthcare Providers | 5 – 11 years of age, orange cap (must dilute) | January 3, 2022 |
| For Recipients and Caregivers | 12 years of age and older | January 31, 2022 |
| For Recipients and Caregivers | 5 – 11 years of age | January 3, 2022 |
| Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine | All | February 16, 2022 |
Pfizer-BioNTech Regulatory Information
| Information | Date |
|---|---|
| Letter Granting EUA Amendment | January 31, 2022 |
| Decision Memorandum Addendum | January 6, 2021 |
| Decision Memorandum | December 30, 2021 |
| Letter of Authorization (Reissued) | January 3, 2022 |
| Decision Memorandum | December 8, 2021 |
| Decision Memorandum Addendum | November 19, 2021 |
| Decision Memorandum | November 19, 2021 |
| Decision Memorandum | October 29, 2021 |
| Advisory Committee Meeting Information | October 26, 2021 |
| Decision Memorandum | October 20, 2021 |
| Decision Memorandum | September 24, 2021 |
| Advisory Committee Meeting Information | September 17, 2021 |
| Letter Granting EUA Amendment | September 1, 2021 |
| Concurrence Letter | August 22, 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 | January 3, 2022 |
| Press Release | November 19, 2021 |
| Press Release | October 29, 2021 |
| Press ConferenceExternal Link Disclaimer | October 29, 2021 |
| Advisory Committee WebcastExternal Link Disclaimer | October 26, 2021 |
| Press Release | October 20, 2021 |
| Media CallExternal Link Disclaimer | October 20, 2021 |
| Press Release | September 22, 2021 |
| Advisory Committee WebcastExternal Link Disclaimer | September 17, 2021 |
| Press Release | August 23, 2021 |
| Press Release | August 12, 2021 |
| FDA In Brief | May 19, 2021 |
| Press Release | May 10, 2021 |
| Press ConferenceExternal Link Disclaimer | May 10, 2021 |
| Press Release | February 25, 2021 |
| Press Release | December 11, 2020 |
| Press ConferenceExternal Link Disclaimer | December 11, 2020 |
| Advisory Committee WebcastExternal Link Disclaimer | December 10, 2020 |