On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

Janssen COVID-19 Vaccine is available under EUA as a single primary vaccination dose in individuals 18 years of age and older and as a single booster dose in people 18 years of age and older.

The Janssen COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) booster dose following completion of primary vaccination with a different available COVID-19 vaccine. For example, Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Janssen COVID-19 Vaccine.

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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

Media Materials and Webcasts

 

Translations of the Fact Sheet for Recipients and Caregivers