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  1. Coronavirus Disease 2019 (COVID-19)

Janssen COVID-19 Vaccine

April 23, 2021: The FDA amended the emergency use authorization of the Johnson & Johnson (Janssen) COVID-19 vaccine to include information about a very rare and serious type of blood clot in people who receive the vaccine. View frequently asked questions

Report vaccine side effects toll-free at 1-800-822-7967 or online to FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.


Emergency Use Authorization Status:
Authorized
Name:
Janssen COVID-19 Vaccine
Manufacturer:
Janssen Biotech Inc.,
a Janssen Pharmaceutical Company of Johnson & Johnson

Authorized Use

For the prevention of coronavirus disease 2019 (COVID-19) for individuals 18 years of age and older

Common Side Effects

The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects occurred within 1-2 days following vaccination and were mild to moderate in severity and lasted 1-2 days. Learn more.

Fact Sheets (English) and FAQs

Regulatory Information

Information Date
Concurrence Letter June 16, 2021
FDA Decision Memorandum Addendum June 15, 2021
Concurrence Letter June 15, 2021
FDA Decision Memorandum June 11, 2021
Letter of Authorization (Reissued) June 10, 2021
Concurrence Letter (concurring with the extension of the shelf-life of Janssen COVID-19 Vaccine stored at 2-8oC, from 3 months to 4.5 months) June 10, 2021
Letter Granting EUA Amendment April 23, 2021
Letter Granting EUA Amendment March 29, 2021
FDA Decision Memorandum February 27, 2021
Advisory Committee Meeting Information February 26, 2021

Media Materials and Webcasts

Information Date
Press Release April 23, 2021
Joint FDA and CDC Press Conference April 23, 2021
Joint CDC and FDA Statement April 13, 2021
Joint FDA and CDC Media Call April 13, 2021
Media Call February 27, 2021
Press Release February 27, 2021
Advisory Committee Meeting Webcast February 26, 2021

 

Translations of the Fact Sheet for Recipients and Caregivers

Fact Sheet Language
بيان حقائق لمتلقي ومقدمي الرعاية الصحية
(April 23, 2021)
عربي (Arabic)
প্রাপক এবং সেবাপ্রদানকারীদের জন্য তথ্য পত্র
(April 23, 2021)
ইংরেজী (Bengali)
ကာကွယ်ဆေး လက်ခံရရှိသူများနှင့် စောင့်ရှောက်မှု ပေးသူများအတွက် သတင်းအချက်အလက် စာရွက်
(April 23, 2021)
မြန်မာ (Burmese)
ᎤᏙᎯᏳ ᎪᏪᎳᏅ ᎾᏍᎩᎾ ᏗᏂᏁᏍᎩ ᎠᎴ ᎤᎾᏓᎦᏎᏍᏗ ᏗᎾᏓᏍᏕᎵᏍᎩ
(April 23, 2021)
ᎩᎵᏏ (Cherokee)
接受者和护理者须知
(April 23, 2021)
中文 (Chinese, Simplified)
TAROPWEN AFFAT (IKA FACT SHEET) REN CHON ANGEI ME CHON TUMUN
(April 23, 2021)
Foosun Chuuk (Chuukese)
برگه اطلاعات برای دریافت کنندگان و ارائه کنندگان مراقبت
(April 23, 2021)
فارسی (Farsi)
FICHE D'INFORMATION POUR LES BÉNÉFICIAIRES ET LES AIDANTS
(April 23, 2021)
Français (French)
MERKBLATT FÜR EMPFÄNGER UND BETREUER
(April 23, 2021)
Deutsch (German)
પ્રાપ્તિકર્તા અને સંભાળ રાખનારાઓ માટે તથ્ય શીટ
(April 23, 2021)
ગુજરાતી (Gujarati)
FEY ENFOMASYON POU MOUN K’AP RESEVWA AVEK MOUN K’AP BAY SWEN
(April 23, 2021)
Kreyòl Ayisyen (Haitian Creole)
प्राप्तकर्ताओं और देखभाल कर्ताओं के लिए तथ्य पत्र/फैक्ट शीट
(April 23, 2021)
हिन्दी (Hindi)
DAIM NTAWV QHIA TSEEB RAU COV NEEG TAU KEV PAB THIAB COV NEEG ZOV TU
(April 23, 2021)
Hmoob (Hmong)
SCHEDA INFORMATIVA PER RICEVENTI E ASSISTENTI
(April 23, 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
(April 23, 2021)
日本 (Japanese)
បញ្ជីហេតុការណ៍សម្រាប់អ្នកទទួលនិងអ្នកថែរទាំ
(April 23, 2021)
ភាសាអង់គ្លេស (Khmer)
환자와 의료진을 위한 정보지
(April 23, 2021)
한국어 (Korean)
PEBA IN KŌMEḶEḶE ÑAN RO REJ BŌK WĀ IM RO REJ LALE RO RE NAÑINMEJ
(April 23, 2021)
Pālle (Marshallese)
BAA ÁDAHWIILYÁNÍÍ DÓÓ BÁ ADAHAZT’I’ÍÍ NAALTSOOS BEE ÉÉHÓZINÍÍ ÁT’É
(April 23, 2021)
Bilagáanaa Bizaad jí (Navajo)
ARKUSZ INFORMACYJNY DLA OSÓB SZCZEPIONYCH I ICH OPIEKUNÓW
(April 23, 2021)
Polski (Polish)
FICHA TÉCNICA PARA BENEFICIÁRIOS E PROFISSIONAIS DE SAÚDE
(April 23, 2021)
Português (Portuguese)
ИНФОРМАЦИОННЫЙ БЮЛЛЕТЕНЬ ДЛЯ РЕЦИПИЕНТОВ И СПЕЦИАЛИСТОВ ПО УХОДУ
(April 23, 2021)
Русский (Russian)
XAASHIDA MACLUUMAADKA EE LOOGU TALAGALAY TALLAAL QAATAYAASHA IYO DARYEELAYAASHA
(April 23, 2021)
Soomaali (Somali)
HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO
(April 23, 2021)
Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA
(April 23, 2021)
Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
(April 23, 2021)
Tiếng Việt (Vietnamese)
אינפאָרמאַציע בלאט פאר די וועלכע באקומען די וואַקסין און פאר געהילפן (גבאים)
(April 23, 2021)
אידיש (Yiddish)
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