A panel of outside advisers to the U.S. Food and Drug Administration (FDA) voted to endorse a vaccine from Pfizer for respiratory syncytial virus (RSV) on Tuesday.
The majority vote to endorse Pfizer’s product brings it closer to potentially becoming the first approved vaccine for RSV for older adults in the United States. The FDA had granted priority review to Pfizer’s application for the vaccine in December 2022.
Unlike typical past vaccine recommendations, the 12 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) were not unanimous in their vote for Pfizer’s product, called Abrysvo (RSVPreF).
For two questions (pdf) on whether Pfizer’s data in a clinical study it conducted were enough to support the safety and efficacy of the vaccine to prevent lower respiratory tract disease caused by RSV in those 60 years or older, the panel voted 7–4 in favor of the drug, with one abstaining member….