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.
On October 20, 2021, the FDA authorized a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older. Also on October 20, 2021, the FDA authorized the use of a heterologous (or “mix and match”) booster dose for currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. Therefore, Janssen COVID-19 Vaccine recipients 18 years of age and older may receive a single booster dose of Janssen COVID-19 Vaccine, Moderna COVID-19 Vaccine (half dose) or Pfizer-BioNTech COVID-19 Vaccine at least two months after receiving their Janssen COVID-19 Vaccine primary vaccination.
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
Information | Last Updated |
---|---|
Fact Sheet for Healthcare Providers Administering Vaccine | October 20, 2021 |
Fact Sheet for Recipients and Caregivers | October 20, 2021 |
Frequently Asked Questions on the Janssen COVID-19 Vaccine | April 27, 2021 |
Regulatory Information
Media Materials and Webcasts
Information | Date |
---|---|
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 (October 20, 2021) |
中文 (Chinese, Simplified) |
환자와 의료진을 위한 정보지 (October 20, 2021) |
한국어 (Korean) |
HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO (October 20, 2021) |
Español (Spanish) |
FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA (October 20, 2021) |
Tagalog (Tagalog) |
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC (October 20, 2021) |
Tiếng Việt (Vietnamese) |