September 22, 2021: authorizes Pfizer-BioNTech COVID-19 Vaccine booster sheep for specific populations. View push release.

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On respectable 23, 2021, the 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

InformationLast Updated
Package InsertAugust 23, 2021
Summary Basis for Regulatory ActionAugust 23, 2021
Approval LetterAugust 23, 2021
FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español)August 23, 2021

InformationLast Updated
Fact paper for medical care Providers Administering VaccineSeptember 22, 2021
Fact Sheet for Recipients and CaregiversSeptember 22, 2021
Frequently Asked concerns on the Pfizer-BioNTech COVID-19 VaccineAugust 23, 2021

Decision MemorandumSeptember 24, 2021
Letter the Authorization (Reissued)September 22, 2021
Concurrence LetterAugust 22, 2021
Decision MemorandumAugust 12, 2021
Letter granting EUA AmendmentMay 19, 2021 Decision MemorandumMay 10, 2021
Letter approving EUA AmendmentApril 6, 2021
Letter giving EUA AmendmentJanuary 22, 2021
Letter granting EUA AmendmentJanuary 6, 2021 Decision Memorandum December 11, 2020
Advisory Committee conference InformationDecember 10, 2020

Press ReleaseSeptember 22, 2021
Advisory Committee WebcastSeptember 17, 2021
Press ReleaseAugust 23, 2021
Press ReleaseAugust 12, 2021 In BriefMay 19, 2021
Press ReleaseMay 10, 2021
Press ConferenceMay 10, 2021
Press ReleaseFebruary 25, 2021
Press ReleaseDecember 11, 2020
Press ConferenceDecember 11, 2020
Advisory Committee WebcastDecember 10, 2020

Translations of the Pfizer-BioNTech fact Sheet because that Recipients and Caregivers

At this time, the 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
Fact SheetLanguage
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)
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)

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