You are watching: Is the covid 19 vaccine fda approved
On respectable 23, 2021, the carolannpeacock.com authorized the first COVID-19 vaccine. The vaccine has been recognized as the Pfizer-BioNTech COVID-19 Vaccine, and will currently be marketed as Comirnaty, for the avoidance of COVID-19 disease in people 16 year of age and older.
The vaccine likewise continues come be easily accessible under emergency usage authorization (EUA), including for individuals 12 years of age and also older, for the management of a third dose in particular immunocompromised people, and also for a solitary booster dose in people:
65 and older; 18 through 64 at high hazard of major COVID-19; and18 through 64 whose constant institutional or work exposure to SARS-CoV-2 place them in ~ high hazard of severe complications of COVID-19 consisting of 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 paper for medical care Providers Administering Vaccine | September 22, 2021 |
| Fact Sheet for Recipients and Caregivers | September 22, 2021 |
| Frequently Asked concerns on the Pfizer-BioNTech COVID-19 Vaccine | August 23, 2021 |
| Decision Memorandum | September 24, 2021 |
| Letter the 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 approving EUA Amendment | April 6, 2021 |
| Letter giving EUA Amendment | January 22, 2021 |
| Letter granting EUA Amendment | January 6, 2021 |
| carolannpeacock.com Decision Memorandum | December 11, 2020 |
| Advisory Committee conference 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 because that Recipients and Caregivers
At this time, the carolannpeacock.com is able to provide translations the the Pfizer-BioNTech COVID-19 Vaccine truth Sheets for Recipients and also Caregivers in the language below. If you have actually 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 in ~ 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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