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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

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.

Additional Resources:

• Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement
• 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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