You are watching: Is the covid 19 vaccine fda approved
On August 23, 2021, the carolannpeacock.com approved the first 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 disease in individuals 16 years of age and older.
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 years of age and older, for the administration of a third dose in certain immunocompromised people, and for a single booster dose in people:
65 and older; 18 through 64 at high risk of severe COVID-19; and18 through 64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.Comirnaty Information
| Package Insert | August 23, 2021 |
| Summary Basis for Regulatory Action | August 23, 2021 |
| Approval Letter | August 23, 2021 |
| FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español) | August 23, 2021 |
| Fact Sheet for Healthcare Providers Administering Vaccine | September 22, 2021 |
| Fact Sheet for Recipients and Caregivers | September 22, 2021 |
| Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine | August 23, 2021 |
| Decision Memorandum | September 24, 2021 |
| Letter of Authorization (Reissued) | September 22, 2021 |
| Concurrence Letter | August 22, 2021 |
| Decision Memorandum | August 12, 2021 |
| Letter Granting EUA Amendment | May 19, 2021 |
| carolannpeacock.com 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 |
| carolannpeacock.com Decision Memorandum | December 11, 2020 |
| Advisory Committee Meeting Information | December 10, 2020 |
| Press Release | September 22, 2021 |
| Advisory Committee Webcast | September 17, 2021 |
| Press Release | August 23, 2021 |
| Press Release | August 12, 2021 |
| carolannpeacock.com 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 Pfizer-BioNTech Fact Sheet for Recipients and Caregivers
At this time, the carolannpeacock.com is able to provide translations of the Pfizer-BioNTech COVID-19 Vaccine Fact Sheets for Recipients and Caregivers in the languages below. If you have a special language request, please contact: carolannpeacock.comoma
| 接受者和护理者须知(September 22, 2021) | 中文 (Chinese, Simplified) |
| 환자와 의료진을 위한 정보지(September 22, 2021) | 한국어 (Korean) |
| HOJA INFORMATIVA PARA RECEPTORES Y PROVEDORES DE CUIDADO(September 22, 2021) | Español (Spanish) |
| FACT SHEET PARA SA MGA TATANGGAP AT TAGAPAG-ALAGA(September 22, 2021) | Tagalog (Tagalog) |
| TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC(September 22, 2021) | Tiếng Việt (Vietnamese) |
| QABUL QILUVCHILAR VA PARVARISH QILUVCHILAR UCHUN COMIRNATY(September 22, 2021) | Uzbeck (Uzbeck) |
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