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  1. Coronavirus Disease 2019 (COVID-19)

Janssen COVID-19 Vaccine

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). On April 23, 2021, the FDA amended the EUA to include information about a very rare and serious type of blood clot in people who receive the vaccine. 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
FDA Decision Memorandum Addendum September 14, 2021
Concurrence Letter September 14, 2021
FDA Decision Memorandum Addendum September 8, 2021
Concurrence Letter September 8, 2021
Letter Granting EUA Amendment August 30, 2021
Concurrence Letter (shelf life extension to 6 months) July 28, 2021
FDA Decision Memorandum Addendum July 13, 2021
Concurrence Letter  July 13, 2021
Letter Granting EUA Amendment July 12, 2021
Concurrence Letter (Reissued) July 2, 2021
Concurrence Letter (Reissued) July 2, 2021
Concurrence Letter July 2, 2021
FDA Decision Memorandum Addendum July 1, 2021
FDA Decision Memorandum Addendum 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
(July 12, 2021)
عربي (Arabic)
প্রাপক এবং সেবাপ্রদানকারীদের জন্য তথ্য পত্র
(July 12, 2021)
ইংরেজী (Bengali)
ကာကွယ်ဆေး လက်ခံရရှိသူများနှင့် စောင့်ရှောက်မှု ပေးသူများအတွက် သတင်းအချက်အလက် စာရွက်
(July 12, 2021)
မြန်မာ (Burmese)
ᎤᏙᎯᏳ ᎪᏪᎳᏅ ᎾᏍᎩᎾ ᏗᏂᏁᏍᎩ ᎠᎴ ᎤᎾᏓᎦᏎᏍᏗ ᏗᎾᏓᏍᏕᎵᏍᎩ
(July 12, 2021)
ᎩᎵᏏ (Cherokee)
接受者和护理者须知
(July 12, 2021)
中文 (Chinese, Simplified)
TAROPWEN AFFAT (IKA FACT SHEET) REN CHON ANGEI ME CHON TUMUN
(July 12, 2021)
Foosun Chuuk (Chuukese)
برگه اطلاعات برای دریافت کنندگان و ارائه کنندگان مراقبت
(July 12, 2021)
فارسی (Farsi)
FICHE D'INFORMATION POUR LES BÉNÉFICIAIRES ET LES AIDANTS
(July 12, 2021)
Français (French)
MERKBLATT FÜR EMPFÄNGER UND BETREUER
(July 12, 2021)
Deutsch (German)
પ્રાપ્તિકર્તા અને સંભાળ રાખનારાઓ માટે તથ્ય શીટ
(July 12, 2021)
ગુજરાતી (Gujarati)
FEY ENFOMASYON POU MOUN K’AP RESEVWA AVEK MOUN K’AP BAY SWEN
(July 12, 2021)
Kreyòl Ayisyen (Haitian Creole)
प्राप्तकर्ताओं और देखभाल कर्ताओं के लिए तथ्य पत्र/फैक्ट शीट
(July 12, 2021)
हिन्दी (Hindi)
DAIM NTAWV QHIA TSEEB RAU COV NEEG TAU KEV PAB THIAB COV NEEG ZOV TU
(July 12, 2021)
Hmoob (Hmong)
SCHEDA INFORMATIVA PER RICEVENTI E ASSISTENTI
(July 12, 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
(July 12, 2021)
日本 (Japanese)
បញ្ជីហេតុការណ៍សម្រាប់អ្នកទទួលនិងអ្នកថែរទាំ
(July 12, 2021)
ភាសាអង់គ្លេស (Khmer)
환자와 의료진을 위한 정보지
(July 12, 2021)
한국어 (Korean)
PEBA IN KŌMEḶEḶE ÑAN RO REJ BŌK WĀ IM RO REJ LALE RO RE NAÑINMEJ
(July 12, 2021)
Pālle (Marshallese)
BAA ÁDAHWIILYÁNÍÍ DÓÓ BÁ ADAHAZT’I’ÍÍ NAALTSOOS BEE ÉÉHÓZINÍÍ ÁT’É
(July 12, 2021)
Bilagáanaa Bizaad jí (Navajo)
ARKUSZ INFORMACYJNY DLA OSÓB SZCZEPIONYCH I ICH OPIEKUNÓW
(July 12, 2021)
Polski (Polish)
FICHA TÉCNICA PARA BENEFICIÁRIOS E PROFISSIONAIS DE SAÚDE
(July 12, 2021)
Português (Portuguese)
ИНФОРМАЦИОННЫЙ БЮЛЛЕТЕНЬ ДЛЯ РЕЦИПИЕНТОВ И СПЕЦИАЛИСТОВ ПО УХОДУ
(July 12, 2021)
Русский (Russian)
XAASHIDA MACLUUMAADKA EE LOOGU TALAGALAY TALLAAL QAATAYAASHA IYO DARYEELAYAASHA
(July 12, 2021)
Soomaali (Somali)
HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO
(July 12, 2021)
Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA
(July 12, 2021)
Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
(July 12, 2021)
Tiếng Việt (Vietnamese)
אינפאָרמאַציע בלאט פאר די וועלכע באקומען די וואַקסין און פאר געהילפן (גבאים)
(July 12, 2021)
אידיש (Yiddish)
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