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          Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 VaccinesPress Announcements FDA News Release
  Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

  
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    PrintFor Immediate Release:
                  August 28, 2020
 

 

  The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.

**“The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to address the general development of COVID-19 vaccines on October 22nd. The agency is also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate,” said FDA Commissioner Stephen M. Hahn, M.D. “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible. A discussion with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding regarding clinical development of these vaccines indicated to prevent COVID-19 and the data needed to facilitate their authorization or licensure. It is critical for people to see FDA’s expectations for data to support safety and effectiveness.”**

The meeting will be held on Oct. 22, 2020, from 10:00 a.m. ET to 5:00 p.m. ET via webcast. The FDA intends to make background material available to the public, including the meeting agenda and Committee roster, no later than two business days before the meeting. In general, advisory committees include a Chair, several members, plus a consumer, industry and sometimes a patient representative. Additional experts with special knowledge may be added for individual meetings as needed. Although the committees provide advice to the agency, final decisions are made by the FDA.

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
              Coronavirus Disease 2019 (COVID-19)
	Vaccines and Related Biological Products Advisory Committee
	Development and Licensure of Vaccines to Prevent COVID-19
	Advisory Committee Calendar
	JAMA: Unwavering Regulatory Safeguards for COVID-19 Vaccines

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                                                                                  Content current as of:
      08/28/2020
               
               
Regulated Product(s)
		 BiologicsHealth Topic(s)
			  Infectious Disease
			    			       			    			       Coronavirus   

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