SUMMARY  

• On May 22, 2023, Janssen requested the voluntary withdrawal of the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. On June 1, 2023, the Food and Drug Administration (FDA) revoked the EUA for this vaccine.¹
• The last lots of the vaccine purchased by the United States (U.S.) Government expired on May 13, 2023.   
• The discontinuation and EUA withdrawal are not associated with concerns about the quality or safety of the Janssen COVID-19 Vaccine.
• Any unused COVID-19 vaccine or waste material should be disposed in compliance with local guidance.
• For inquiries about the status of Janssen COVID-19 Vaccine outside of the U.S., please visit https://www.janssen.com/covid-19-vaccine.
• For additional information, please visit http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/janssen-covid-19-vaccine.