(Dmytro “Henry” Aleksandrov, Headline USA) Big Pharma giants Pfizer wants the U.S. Food and Drug Administration to approve a first-of-its-kind vaccine that is reportedly supposed to protect infants from the respiratory syncytial virus, but only managed to pass half of it trial goals.
The Daily Wire reported that the Bivalent Prefusion F Vaccine is administered to expectant mothers during the second half of their pregnancy to protect infants against RSV.
The late-stage trial data showed that the experimental vaccine was 82% effective in preventing severe cases of the potentially deadly virus in infants 90 days after birth. However, the same trial data also showed that the numbers dropped to 69% efficacy in preventing severe infections up to 180 days after a baby is born. The new vaccine by Pfizer also failed to reduce non-severe illness in newborns.
According to Pfizer, the FDA accepted the pharmaceutical company’s license for application for the vaccine in February. The FDA will decide on its use by August.
“If approved, RSVF 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,” Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer of Vaccine Research & Development, said in February.
“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.”
The multi-billion company studied results in 3,570 infants for the study. During the 90-day time frame, Pfizer discovered that the babies whose mothers received the experimental vaccine contracted severe illness compared to 33 in the placebo group. The company also found out that, during the 180-day time frame, 19 infants whose moms were injected came down with severe illness compared to 62 in the placebo group.
