FDA Panel Recommends Approval of First Maternal RSV Vaccine

If approved, the vaccine would be administered during pregnancy to protect infants from RSV, a common respiratory virus and leading cause of hospitalization in babies under 6 months.
In clinical trials, the vaccine was 82% effective at preventing severe RSV in infants during the first 3 months of life and 69% effective during the first 6 months.
Some panel members expressed concerns about a slightly higher rate of premature births in the vaccinated group but agreed the data supported the vaccine's safety.
The vaccine is made by Pfizer and would be the first approved to guard against RSV by vaccinating pregnant women.
The FDA is expected to make a final decision on approval by late August.