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  1. Coronavirus Disease 2019 (COVID-19)

Pfizer-BioNTech COVID-19 Vaccine

On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. On May 10, 2021, the FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.


Emergency Use Authorization Status:
Authorized
Name:
Pfizer-BioNTech COVID-19 Vaccine
Manufacturer:
Pfizer Inc.

Authorized Use

For the prevention of 2019 coronavirus disease (COVID-19) for individuals 12 years of age and older

Common Side Effects

The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. Learn more.

Fact Sheets (English) and FAQs

Regulatory Information

Media Materials and Webcasts

Information Date
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 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
(May 10, 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
(June 25, 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
(June 25, 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
(May 10, 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
(June 25, 2021)
Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT TAGAPAG-ALAGA
(June 25, 2021)
Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
(June 25, 2021)
Tiếng Việt (Vietnamese)
אינפאָרמאַציע בלאט פאר די וועלכע באקומען און פאר הילפער (גבאים)
(June 25, 2021)
אידיש (Yiddish)

 

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