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          Emergency Use Authorization for Vaccines to Prevent COVID-19Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Emergency Use Authorization for Vaccines to Prevent COVID-19
					Guidance for Industry
		
		March 2022


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2020-D-1137
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research


This guidance is intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance before that date. For further information, refer to 85 FR 15417, March 13, 2023, and https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19.


FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.  This document supersedes the guidance of the same title issued in May 2021 (which superseded the guidance of the same title issued October 2020 and reissued February 2021).


 
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						All written comments should be identified with this document's docket number: FDA-2020-D-1137.



  
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                                                                                  Content current as of:
      03/13/2023
         
                  
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