FDA Announces Advisory Meeting for Booster Dose of Pfizer-BioNTech Vaccine

The next VRBPAC meeting, which will be held in 2 weeks, is expected to address the Food and Drug Administration's (FDA) supplemental Biologics License Application (sBLA) for the booster dose of the BNT162b2 (Comirnaty) Pfizer-BioNTech vaccine that was submitted last week.

The 2 companies are seeking marketing and prescribing of a third booster dose of the vaccine for fully vaccinated individuals aged 16 years and older.

“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Research and Evaluation, said in a statement.

The submission included phase 3 clinical trial data involving 306 participants who received a third dose of the mRNA COVID-19 vaccine.

The companies just received full FDA approval for BNT162b2 on August 23, and made it the first COVID-19 vaccine approved in the US.

The VRBPAC meeting coincides with the Biden Administration’s plans to begin offering booster doses of the COVID-19 vaccines starting September 20.

“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,” Marks said in the same statement.

This meeting is instrumental in helping determine if the data shows evidence to support the booster and it is open to the public to view via a livestream on the FDA’s YouTube channel or through a webcast from the agency’s website.