Pharmaceutical giant Pfizer is seeking FDA approval for a first-of-its-kind vaccine aimed at protecting infants from the respiratory syncytial virus (RSV), but trial data shows the shot failed to meet one of its two main goals.
The Bivalent Prefusion F Vaccine developed by Pfizer is administered to expectant mothers during the second half of their pregnancy to protect infants against RSV. According to the late-stage trial data, the experimental vaccine was 82% effective in preventing severe cases of the potentially deadly virus in infants 90 days after birth, but that dropped to 69% efficacy in preventing severe infections up to 180 days after a baby is born. The Pfizer shot also failed to meet its second goal of reducing non-severe illness in newborns, Reuters reported.
The U.S. Food and Drug Administration (FDA) accepted Pfizer’s license for application for the vaccine in February, according to the pharmaceutical company, and the agency will decide on its use by 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,” said Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer of Vaccine Research & Development, 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.”
Pfizer studied results in 3,570 infants for the study. During the 90-day time frame, six of the babies whose mothers received the vaccine contracted severe illness compared to 33 in the placebo group, and during the 180-day time frame, 19 infants whose moms were injected came down with severe illness compared to 62 in the placebo group.
Pfizer released the initial trial results of the new vaccine last November, and those results are still being reviewed by regulators in the U.S. and Europe, Reuters reported.
Up to 80,000 children younger than 5 in the U.S. are hospitalized as a result of RSV infections every year, according to the Centers for Disease Control and Prevention (CDC). Between 100-300 children under five die from the virus each year.
Pfizer faced heavy criticism earlier this year after a man identified as Jordon Walker — the company’s director of research and development, strategic operations — told Project Veritas in a hidden camera sting that Pfizer considered mutating SARS-COV-2 through “directed evolution” to develop new vaccines. Pfizer denied that it conducts gain-of-function research after the Project Veritas video attracted over 20 million views.
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A second video dump from Project Veritas showed Walker admitting that Pfizer’s COVID vaccine could affect female fertility.