On May 22, 2023, Janssen Biotech, Inc. requested the voluntary withdrawal of the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and Janssen does not intend to update the strain composition of this vaccine to address emerging variants. On June 1, 2023, FDA revoked the EUA for this vaccine. Fact sheets are archived as of May 01, 2023 and Janssen does not intend to update.

 

For additional information, please visit: https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/janssen-covid-19-vaccine.

Report an Adverse Event

• Report an Adverse Event to FDA VAERS at www.vaers.hhs.gov/reportevent.html or call the FDA at 1-800-822-7967

• Report an Adverse Event to Janssen at 1-800-JANSSEN

Report a Product Quality Complaint

• Report a Product Quality Complaint to Janssen at 1-800-JANSSEN