The Janssen COVID-19 vaccine is authorized for use under an EUA for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 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. The Janssen COVID-19 Vaccine is a suspension for intramuscular injection. Primary Vaccination The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL). Booster Dose A first booster dose (0.5 mL) of Janssen COVID-19 Vaccine may be administered at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine.

For the most recent Fact Sheets, please see www.janssencovid19vaccine.com. For information on clinical trials that are testing the use of the Janssen COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov.

For COVID-19 Vaccine policies for pregnant and lactating people worldwide, please see, Pregnancy and Lactation Positions by Country for the Johnson & Johnson Vaccine (Janssen)