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Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.

For nearly 11 months, we have all been learning to live and function in a state of uncertainty, adjusting to a “new normal” as the COVID-19 pandemic has drastically affected the way most of us live, and has also tragically claimed the lives of hundreds of thousands of Americans.

We recognize the urgent need for medical countermeasures to diagnose, treat, and prevent this novel virus and have been working diligently to facilitate their development and availability. In particular, the FDA has been working tirelessly with public and private sectors to facilitate the rapid development of COVID-19 vaccines without sacrificing our rigorous scientific standards for safety and effectiveness.

Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, is meeting to discuss the first request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH.

The FDA recognizes that transparency and dialogue are critical to building public confidence in COVID-19 vaccines. An open discussion with this committee—available for public viewing and with public input—about the totality of the scientific evidence regarding the safety and effectiveness of Pfizer and BioNTech’s vaccine will help ensure clear public understanding of...