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

For Immediate Release: December 10, 2020 Statement From:

Statement Author

Leadership Role

Commissioner of Food and Drugs - Food and Drug Administration

Espaol

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 FDAs 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 committeeavailable for public viewing and with public inputabout the totality of the scientific evidence regarding the safety and effectiveness of Pfizer and BioNTechs vaccine will help ensure clear public understanding of the scientific data and information that the FDA evaluates to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19.

The FDAs career staffmade up of physicians, biologists, chemists, epidemiologists, statisticians and other professionalshave been working around the clock to thoroughly evaluate the data and information in the EUA request, for this potential COVID-19 vaccine, in a comprehensive and science-based manner. I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it.

The FDA is considered the "gold standard" regulator of medical products. The process that the FDA uses to review is respected worldwide because of a well-established history that the FDA has among the most rigorous and accurate review processes globally. Normally, the review process for vaccines studied in tens of thousands of people takes months.

Even though the process has been expedited in association with the review of this EUA, the FDAs expert review staff has reviewed thousands of pages of technical information. These data include, but are not limited to clinical trial data, non-clinical data on the development of the vaccine in the lab, and manufacturing data on how the vaccine is made. FDA career officials have been reviewing the data and information ahead of the public advisory committee meeting to ensure a robust discussion with the independent experts.

Todays meeting is an important step in the process allowing outside scientific experts an opportunity to provide valuable advice and input for the agency to consider as part of its final review. Importantly, final decisions about whether to authorize a vaccine for emergency use will be made by FDAs career officials in the Center for Biologics Evaluation and Research.

After the VRBPAC meeting, FDA career staff will take the committees input into account as they continue their review of the EUA request to determine whether it has met the standards for safety and effectiveness for issuance of an EUA, as well as refine the instructions for use and the informational materials to be provided to those receiving the vaccine.

In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process. However, they know that they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect.

The whole of the FDAmyself includedremains committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, Americans can have trust and confidence in receiving the vaccine for their families and themselves.

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 nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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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...