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  1. Coronavirus (COVID-19) | CBER-Regulated Biologics

Janssen COVID-19 Vaccine

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 they do 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.

Emergency Use Authorization Status:
Revoked (June 1, 2023)
Janssen COVID-19 Vaccine
Janssen Biotech Inc.,
a Janssen Pharmaceutical Company of Johnson & Johnson


Fact Sheets (English)

Regulatory Information (Emergency Use Authorization)

Information Date
Review Memorandum June 1, 2023
Revocation of EUA 27205 June 1, 2023
Letter of Authorization (Reissued) March 13, 2023

Federal Register Notices



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