Pfizer Seeks FDA Approval Of First Vaccine To Protect Infants By Injecting Pregnant Mothers. Late-Stage Trial Failed To Meet One Of Two Goals.

The pharmaceutical giant Pfizer is seeking FDA approval for a groundbreaking vaccine that aims to protect infants from the respiratory syncytial virus (RSV) by administering the shot to pregnant mothers during the second half of their pregnancy. The Bivalent Prefusion F Vaccine is claimed to be the world’s first vaccine for newborns. However, the latest trial showed mixed results.

According to the late-stage trial data published in the New England Journal of Medicine, the vaccine demonstrated 82% efficacy in preventing RSV’s severe cases in infants, 90 days after birth. However, the efficacy rate dropped to 69% in preventing severe infections up to 180 days after delivery. The vaccine also failed in its second trial goal of reducing non-severe illness in newborns.

The US Food and Drug Administration (FDA) has already accepted Pfizer’s license for application, and the agency will decide on the vaccine’s use by August this year.

The RSV virus puts 80,000 under-five-year-old children in the US every year hospitalized, and between 100 and 300 die.

In addition, earlier this year, Pfizer faced criticism after being accused of considering “directed evolution” to develop new vaccines, but the company denied it conducted gain-of-function research.

Project Veritas also released a video of the company’s director of research and development, strategic operations, admitting that Pfizer’s Covid vaccine could affect female fertility.

Overall, the new vaccine offers hope for infants who are vulnerable to respiratory infections. Still, its real-world effects remain unclear until the vaccine gains FDA approval and is adopted by healthcare providers worldwide.