U.S. Poised to Approve Pfizer-BioNTech COVID-19 Vaccine

The FDA advisory panel met yesterday to review trial vaccine data.

December 11, 2020

WASHINGTON—Yesterday, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) 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.

During the meeting, federal officials indicated that the FDA, along with other federal agencies, would keep a close eye on COVID-19 vaccines to monitor length of immunity and other factors, according to an FDA advisory panel, the Wall Street Journal reports.

Nancy Messonnier, a senior official at the U.S. Centers for Disease Control and Prevention (CDC), said the CDC, FDA and U.S. Department of Defense would have “active surveillance” of health-care workers and long-term care facility residents to watch the immunization effects. Researchers will contact trial participants via text.

“We really need people to sign on to this system to provide us with the best data possible,” she said.

“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,” said FDA Commissioner Stephen M. Hahn, M.D., in prepared remarks.

“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.”

Meanwhile, the question about who would get the first vaccines has yet to be solved. This week, NACS joined more than 75 health, business and other organizations in the newly formed COVID-19 Vaccine Education and Equity Project to support COVID-19 vaccination, and in particular, to emphasize that the U.S. Food and Drug Administration (FDA) is the gold standard to ensure that authorized and approved COVID-19 vaccines are safe and effective. 

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