RSV vaccine for pregnant women protects their newborns but is it ready for US sale?

By LAURAN NEERGAARD
AP Medical Writer

WASHINGTON (AP) — Federal health advisers are debating a first-of-its-kind RSV vaccine to protect newborns by immunizing their moms late in pregnancy. The virus fills hospitals with wheezing babies each winter. Pfizer’s research shows a late-pregnancy shot is 82% effective at preventing severe RSV in the infants’ first months of life. Food and Drug Administration scientists say it appears safe but have some questions about premature birth. The agency recently approved a different RSV vaccine for older adults, the world’s first made by rival GSK. FDA will consider recommendations from Thursday’s advisory panel in deciding the fate of Pfizer’s maternal vaccine.