FDA to weigh Pfizer’s COVID-19 booster application

The Food and Drug Administration announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for the administration of a third dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years old and older.

The meeting will be held on Sept. 17 from 8:30 a.m. to 3:45 p.m. ET.

The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.

[Read more: Pfizer's COVID-19 vaccine clears key hurdle]

In general, advisory committees include a Chair, members with scientific, medical and public health expertise, and a consumer and industry representative. Additional members with specific expertise may be added for individual meetings as needed.

The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube channel; the meeting will also be webcast on the FDA website.

Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation said, “The administration recently announced a plan to prepare for additional COVID-19 vaccine doses, or ‘boosters,’ this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses.

[Read more: Trial data shows Pfizer COVID-19 vaccine is 90% effective]

Marks continued, “The process for authorizing or approving the use of a booster dose of a COVID-19 vaccine involves each vaccine manufacturer submitting data pertaining to safety and effectiveness to the agency to support this use. The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making. Should the data received from other manufacturers raise unique questions that would benefit from the committee’s input, the agency intends to consider additional public discussions. 

“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines. The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner.”