Current Report Articles
FDA Recommends Approval of Vaccine to Prevent RSV in Infants through Maternal Immunization
Immunize (May 26, 2023) – On May 18, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee voted to recommend the FDA approve Pfizer's respiratory syncytial virus prefusion F vaccine candidate for maternal immunization in the third trimester to prevent RSV in infants from birth up to six months of age. The committee voted 14 to zero on effectiveness and ten to four on safety. The vaccine candidate is currently under FDA review for the prevention of medically attended lower respiratory tract disease and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. The FDA's decision on the potential approval of RSVpreF for the prevention of MA-LRTD and severe MA-LRTD caused by RSV in infants by active immunization of pregnant individuals is expected in August 2023.
--Karen Braman