FDA sets date for COVID-19 vaccine booster meeting

 

The Food and Drug Administration (FDA) announced that its Vaccines and Related Biological Products Advisory Committee (VRBAC) will meet on Sep 17 to discuss COVID-19 vaccine third doses and specifically address the Pfizer-BioNTech supplemental Biologics License Application for administration of a third dose of that vaccine.

Last month, the White House announced—contingent on FDA approval and recommendation—that Americans would be eligible for a third dose of mRNA vaccine 8 months after they completed the initial two-dose series.

“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Research and Evaluation, in the FDA announcement. “The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner.”

The meeting will be livestreamed on the agency’s YouTube channel.

In the announcement, the FDA noted, “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.”

 

 

read the full story