Pfizer, the pharmaceutical titan, is now trying to strongarm the FDA in approving a new first-of-its-kind vaccine that is trying to protect infants from the respiratory syncytial virus (RSV), despite data from the trials showing that the new vaccine outright failed to meet one of the two main goals set out for it.
Developed by Pfizer, the Bivalent Prefusion F Vaccine is given to expectant mothers throughout the late stages of their pregnancy in order to try and pass along protection against RSV to the unborn children. As found in the data of the late-stage trials, the highly experimental vaccine was roughly 82% effective at preventing severe cases of the highly dangerous virus for infants 90 days after birth, but the efficacy plummeted to 69% for preventing severe infections up to 180 days after a baby is born. This new Pfizer shot also totally failed to reach the second goal set for itself of dropping non-severe illness in newborns, explained a report from Reuters.
The U.S. Food and Drug Administration (FDA) chose to accept Pfizer’s license for the application of the vaccine back in February, as reported by the pharmaceutical titan, and the agency is now slated to give final judgment on its use by as late as August.
“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,” explained Pfizer’s senior vice president and chief scientific officer of Vaccine Research & Development, Annaliesa Anderson, back in a February 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.”
Pfizer looked into the results for 3,570 total infants for this study. Throughout the 90-day time period, a total of sex of the babies whose mothers had been dosed with the vaccine jab contracted severe forms of the illness when compared to 33 out of the placebo group, and throughout the 180-day time period, 19 babies whose mothers were dose with the vaccine came down with severe illness, a statistic compared to the 62 found from the placebo group.
A report from Reuters explained that Pfizer officially released the initial trial results of the new vaccine late last year, and the info was being reviewed by regulators in the U.S. and Europe.