February 22, 2023 – Pfizer’s RSV vaccine is being reviewed by the FDA on an expedited basis, with a verdict expected this summer. If approved, this would be the first vaccine to protect against RSV.
The single-dose vaccine is given to expectant mothers in the second or third trimester of their pregnancy and is designed to protect infants against RSV in the first six months of their life. Data from Pfizer’s clinical trial found that the vaccine was 82% effective at preventing severe disease from RSV in newborns during the first 90 days of life. After those 90 days, the shot was still 70% effective over the first six months.
“If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer in a press release. “We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants.”