U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. News & Events
  3. FDA Newsroom
  4. Press Announcements
  5. FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
  1. Press Announcements

FDA Statement

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

The following is attributed to Acting Commissioner Janet Woodcock, M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research

For Immediate Release:
Statement From:
Janet Woodcock, M.D.

Peter Marks, M.D., PhD.
Director - Center for Biologics Evaluation and Research (CBER)

Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. 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 our federal partners involved in vaccine allocation and distribution 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

###


Inquiries

Media:
FDA Office of Media Affairs
301-796-4540
Consumer:
888-INFO-FDA

Back to Top