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.

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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