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FDA Clears First Vaccine for Newborn Protection Against RSV

The US FDA has approved Pfizer’s vaccine to protect newborns from respiratory syncytial virus (RSV), a common and hospitalization-causing illness. The vaccine, named Abrysvo, is administered to pregnant mothers in their late stages and provides protection for infants up to six months old. In a trial involving over 7,000 pregnant individuals and infants, the vaccine significantly reduced the need for doctor visits or hospitalization.

RSV, a major cause of infant and elderly hospitalizations, is most severe during winter. The recent RSV season was unusually harsh. The FDA’s Dr. Peter Marks stated that infants are highly vulnerable to severe RSV and this approval gives healthcare providers an option to protect them.

After decades of research, there are now multiple RSV protection options, including a new antibody shot for all newborns and vaccines for older age groups. Pfizer’s Abrysvo approval is seen as a milestone for scientific and public health advancement.

Pfizer claims maternal vaccination could prevent thousands of hospitalizations and doctor visits each year. However, the vaccine, given at 32-36 weeks of gestation, doesn’t provide long-term defense. Its effectiveness diminishes with time: three months post-birth, it’s 82% effective against severe RSV, dropping to 69% at six months.

Earlier in the year, FDA advisers endorsed the vaccine’s effectiveness and safety, despite a slightly higher preterm birth rate in babies born to vaccinated mothers. Pfizer plans a large post-market safety study, analyzing commercial data to assess safety and effectiveness. The vaccine is also being studied in higher-risk age groups.