Pfizer’s RSV Vaccine: Two Positive Votes Don’t Necessarily Add Up To AdComm Endorsement
Executive Summary
Pfizer got positive standalone votes on safety and efficacy for its RSV vaccine in older adults at a US FDA advisory committee, but only three advisors – a minority of the 12-member panel – endorsed both the safety and effectiveness of the firm’s candidate.
You may also be interested in...
Pfizer’s Maternal RSV Vaccine Quest May Hinge On FDA Advisors’ Views of Preterm Birth Data
A numerical – but not statistically significant – imbalance in preterm births was seen in two Pfizer studies of its RSV vaccine when given to pregnant people with the aim of protecting newborns.
GSK’s RSV Vaccine Prospects In Youngest Pediatric Patients Looks Unlikely Per US FDA Label
Arexvy is the first vaccine approved for the respiratory virus, but GSK's RSV program may lose out on a key population due to safety concerns for individuals younger than two. For Arexvy, CDC’s advisory committee could limit recommendation to 65 and up at June meeting.
Keeping Track: Showers Of Approvals In US FDA’s May Forecast
Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.