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  1. Coronavirus Disease 2019 (COVID-19)

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

September 22, 2021: FDA authorizes Pfizer-BioNTech COVID-19 Vaccine booster dose for certain populations. View press release.

On August 23, 2021, the FDA 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 people 12 through 15, 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; and
  • 18 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

Information Last Updated
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

 

Pfizer-BioNTech Fact Sheets (English) and FAQs

Pfizer-BioNTech Regulatory Information

Information Date
Letter of Authorization (Reissued) September 22, 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 September 22, 2021
Advisory Committee Webcast 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 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

Fact Sheet Language
بيان حقائق للمتلقي القاح ومقدمي الرعاية
(June 25, 2021)
عربي (Arabic)
প্রাপক ও পরিচর্যাকািীদেি জন্য তথ্যপত্র
(June 25, 2021)
ইংরেজী (Bengali)
ကာကွယ်ဆေး လက်ခံရရှိသူများနှင့် စောင့်ရှောက်မှု ပေးသူများအတွက် သတင်းအချက်အလက် စာရွက်
(June 25, 2021)
မြန်မာ (Burmese)
ᎤᏙᎯᏳ ᎪᏪᎳᏅ ᎾᏍᎩᎾ ᏗᏂᏁᏍᎩ ᎠᎴ ᎤᎾᏓᎦᏎᏍᏗ ᏗᎾᏓᏍᏕᎵᏍᎩ
(June 25, 2021)
ᎩᎵᏏ (Cherokee)
接受者和护理者须知
(August 23, 2021)
中文 (Chinese, Simplified)
TAROPWEN AFFAT (IKA FACT SHEET) REN CHON ANGEI ME CHON TUMUN
(June 25, 2021)
Foosun Chuuk (Chuukese)
برگه اطالعات برای دریافت کنندگان و ارائه کنندگان مراقبت
(June 25, 2021)
فارسی (Farsi)
FICHE D'INFORMATION POUR LES BÉNÉFICIAIRES ET LES AIDANTS
(June 25, 2021)
Français (French)
MERKBLATT FÜR EMPFÄNGER UND BETREUER
(June 25, 2021)
Deutsch (German)
પ્રાપ્તકર્તાઓ અને કાળજી રાખનારા માટે ફેક્ટ શીટ
(June 25, 2021)
ગુજરાતી (Gujarati)
FEY ENFOMASYON POU MOUN K’AP RESEVWA AVEK MOUN K’AP BAY SWEN
(June 25, 2021)
Kreyòl Ayisyen (Haitian Creole)
प्राप्तकर्ताओं और देखभाल कर्ताओं के लिए तथ्य पत्र/फैक्ट शीट
(June 25, 2021)
हिन्दी (Hindi)
DAIM NTAWV QHIA TSEEB RAU COV NEEG TAU KEV PAB THIAB COV NEEG ZOV TU
(June 25, 2021)
Hmoob (Hmong)
SCHEDA INFORMATIVA PER RICEVENTI E ASSISTENTI
(June 25, 2021)
Italiano (Italian)
ワクチン接種を受ける人と介護従事者のためのファクトシート
(June 25, 2021)
日本 (Japanese)
បញ្ជីហេតុការណ៍សម្រាប់អ្នកទទួលនិងអ្នកថែរទាំ
(June 25, 2021)
ភាសាអង់គ្លេស (Khmer)
환자와 의료진을 위한 정보지
(August 23, 2021)
한국어 (Korean)
PEPA IN MEḶEḶE KO REMOOL ÑAN RO REJ LOLOORJAKE Ājmuur IM AENŌṂṂAN
(June 25, 2021)
Pālle (Marshallese)
Bich’į’ azláágo Aa’áhál yání Yaa’ áháyánígíí Yaa’áko nízin doo gi Bił Ííshjáán Alnééh
(June 25, 2021)
Bilagáanaa Bizaad jí (Navajo)
ARKUSZ INFORMACYJNY DLA OSÓB SZCZEPIONYCH I ICH OPIEKUNÓW
(June 25, 2021)
Polski (Polish)
FICHA TÉCNICA PARA RECEPTORES E CUIDADORES
(June 25, 2021)
Português (Portuguese)
ИНФОРМАЦИОННЫЙ БЮЛЛЕТЕНЬ ДЛЯ РЕЦИПИЕНТОВ И СПЕЦИАЛИСТОВ ПО УХОДУ
(June 25, 2021)
Русский (Russian)
XAASHIDA MACLUUMAADKA EE LOOGU TALAGALAY TALLAAL QAATAYAASHA IYO DARYEELAYAASHA
(June 25, 2021)
Soomaali (Somali)
HOJA INFORMATIVA PARA RECEPTORES Y PROVEDORES DE CUIDADO
(August 23, 2021)
Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT TAGAPAG-ALAGA
(August 23, 2021)
Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
(August 23, 2021)
Tiếng Việt (Vietnamese)
אינפאָרמאַציע בלאט פאר די וועלכע באקומען און פאר הילפער (גבאים)
(June 25, 2021)
אידיש (Yiddish)

 

 

 

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