Update: The FDA approved the vaccine for prevention of RSV in newborns on Aug. 21, 2023.
Pfizer’s vaccine designed to be given during pregnancy to prevent RSV in newborns received the backing of an FDA panel on Thursday.
While the Food and Drug Administration is not bound by the Vaccines and Related Biological Products Advisory Committee’s endorsement, it likely will follow it when it takes up the matter in August.
Earlier this month the FDA approved an RSV vaccine for adults 60 and older.
The Pfizer vaccine, RSVpreF, is designed to protect infants from birth to six months by being administered to pregnant individuals.
The FDA panel voted unanimously on the effectiveness of the vaccine and 10 to 4 on its safety based on data from the Phase 3 clinical trial. Some committee members were concerned that giving the vaccine at the same time as others could limit their effectiveness and there was some evidence that those vaccinated might be more likely to deliver their baby prematurely, NPR reported.
The Pfizer vaccine is also under consideration for protecting people 60 and older and the company says it intends to begin clinical trials for healthy children ages 2-5; children 5-18 with underlying medical conditions; high-risk adults 18-60.
If approved in August for pregnant patients, it will be the first RSV vaccine available to protect infants.
“If approved, our RSV vaccine candidate has the potential to be the first maternal immunization vaccine to help protect infants at first breath through their first six months of life from this potentially serious infection.” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.
The contents of this feature are not provided or reviewed by NPWH.