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
Media Materials and Webcasts
| Information | Date |
|---|---|
| Press Release | May 5, 2022 |
| Press Release | October 20, 2021 |
| Media Call | October 20, 2021 |
| Advisory Committee Meeting Webcast | October 15, 2021 |
| 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
| 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) |