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          FDA Statement on Vaccines and Related Biological Products Advisory Committee MeetingPress Announcements FDA Statement
  FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

      The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
  
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    PrintFor Immediate Release:
                  December 17, 2020
                 
                         Statement From:
         Stephen M. Hahn, M.D.            Commissioner of Food and Drugs - Food and Drug Administration
  
                                  ( December 2019 - January 2021 )
                                 
                                    
            Peter  Marks, M.D., PhD.            Director - Center for Biologics Evaluation and Research (CBER)
 

 

  Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

  Related Information
  
  Related Information
              COVID-19 Vaccines
	Emergency Use Authorization for Vaccines Explained
	Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
	Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry

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                                                                                  Content current as of:
      12/17/2020
               
               
Regulated Product(s)
		 BiologicsHealth Topic(s)
			  Infectious Disease
			    			       			    			       Coronavirus   

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