Janssen COVID-19 Vaccine
Janssen COVID-19 Vaccine is available under EUA to prevent COVID-19 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. For these individuals, the Janssen COVID-19 vaccine is authorized as a:
- Single primary vaccination dose
- First booster dose in certain individuals 18 years of age and older at least two months after completing primary vaccination with an authorized or approved COVID-19 vaccine
On February 27, 2021, FDA issued an EUA for the Janssen COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older.
On May 5, 2022, the U.S. Food and Drug Administration limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
- 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) in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
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)
Information | Last Updated |
---|---|
Fact Sheet for Healthcare Providers Administering Vaccine | March 13, 2023 |
Fact Sheet for Recipients and Caregivers | March 13, 2023 |
Regulatory Information (Emergency Use Authorization)
Federal Register Notices
Title | Date |
---|---|
Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability | May 27, 2021 |
Translations of the Fact Sheet for Recipients and Caregivers
接受者和护理者须知 (May 5, 2022) |
中文 (Chinese, Simplified) |
환자와 의료진을 위한 정보지 (May 5, 2022) |
한국어 (Korean) |
HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO (May 5, 2022) |
Español (Spanish) |
FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA (May 5, 2022) |
Tagalog (Tagalog) |
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC (May 5, 2022) |
Tiếng Việt (Vietnamese) |