Members of the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will assemble on December 10 to discuss an emergency use authorization request for Pfizer, Inc.’s and BioNTech’s COVID-19 vaccine candidate.
The candidate made waves earlier this month, with trial data showing a nearly 95 percent efficacy rate against the disease. A major setback, however, is that it requires extremely cold temperatures for extended transport or storage.
“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible,” Dr. Stephen Hahn, FDA Commissioner, said. “A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19.”
During the review, background materials like the meeting agenda and committee roster will be made available to the public. Each meeting will include scientific and public health experts, as well as a consumer, industry, and the occasional patient representative. These experts and representatives act as advisors for the agency. In this regard, they are not the final voice on whether a vaccine candidate will receive an EUA, but they do inform the FDA’s decision.
The meeting itself will be live-streamed, and a notice with details of that meeting should be posted this week.