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          Development and Licensure of Vaccines to Prevent COVID-19Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Development and Licensure of Vaccines to Prevent COVID-19
					Guidance for Industry
		
		October 2023


	Download the  Final Guidance Document 

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


FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  FDA is committed to providing timely guidance to support the response to COVID-19.

The recommendations described in the guidance are expected to assist the Agency and sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19 and reflect the Agency’s current thinking on this issue.

Related Information

Developing and Manufacturing Drugs Including Biologics


 
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					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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						All written comments should be identified with this document's docket number: FDA-2020-D-1137.



  
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          Office of Communication, Outreach and Development (OCOD)
				    		    	
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                                                                                  Content current as of:
      10/19/2023
         
                  
Regulated Product(s)
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			  VaccinesHealth Topic(s)
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			    			       			    			       CoronavirusSearch for FDA Guidance Documents

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