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
  • Single booster dose at least two months after completing primary vaccination with the vaccine
  • Heterologous (or “mix and match”) single booster dose following completion of primary vaccination with a different available COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination. View COVID-19 vaccine booster eligibility.

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) and FAQs

Regulatory Information

Media Materials and Webcasts

 

Translations of the Fact Sheet for Recipients and Caregivers