Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
On 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 |
LOUTEL 