FDA advisory committee met and approved intent to authorize the Pfizer COVID-19 vaccine
The U.S. Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, met 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, announced the FDA.
US Health Secretary Alex Azar announced this morning on Good Morning America that “The FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine. So in the next couple of days, probably, as we work to negotiate with Pfizer the information doctors need to prescribe it appropriately, we should be seeing the authorization of this first vaccine.” He also noted that the FDA will provide a Fact Sheet for physicians that will warn of allergic reactions.
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 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 FDA’s career staff – made up of physicians, biologists, chemists, epidemiologists, statisticians and other professionals – have 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 FDA’s 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.
Thursday’s 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 FDA’s career officials in the Center for Biologics Evaluation and Research.
After the VRBPAC meeting, FDA career staff will take the committee’s 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.
