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                Coronavirus (COVID-19) | CBER-Regulated Biologics

Coronavirus (COVID-19) | CBER-Regulated Biologics Home
          Vaccines, Blood & Biologics
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          Coronavirus (COVID-19) | CBER-Regulated Biologics
          Janssen COVID-19 VaccineCoronavirus (COVID-19) | CBER-Regulated Biologics Janssen COVID-19 Vaccine
  
  	
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    PrintFact Sheets Fact Sheet Translations Información sobre las vacunas para el COVID-19

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)
	Name:
	Janssen COVID-19 Vaccine
	Manufacturer:
	Janssen Biotech Inc.,
	a Janssen Pharmaceutical Company of Johnson & Johnson



Fact Sheets (English)

Information
			Last UpdatedFact Sheet for Healthcare Providers Administering Vaccine
			March 13, 2023Fact Sheet for Recipients and Caregivers
			March 13, 2023

Regulatory Information (Emergency Use Authorization)

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

Federal Register Notices

Title
			DateAuthorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability
			May 27, 2021

                                                                                  Content current as of:
      06/02/2023
              
              
Regulated Product(s)
		 BiologicsHealth Topic(s)
			  Infectious Disease
			    			       			    			       CoronavirusCoronavirus (COVID-19) | CBER-Regulated Biologics
 
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