FDA advisers agree maternal RSV vaccine protects infants, but are divided on its safety
A committee of advisers to the U.S. Food and Drug Administration (FDA) yesterday voted unanimously that a vaccine from Pfizer, given as an injection during pregnancy, is efficacious at protecting infants from severe respiratory syncytial virus (RSV) disease during the first 6 months of life. If approved by the agency, the vaccine would be a major advance against a disease that is the leading cause of hospitalization of U.S. infants. But troubled by side effect data from Pfizer’s trials and by another big drugmaker’s abandonment of a similar vaccine given during pregnancy, the panel split on the question of the vaccine’s safety, with multiple members concerned that it may increase the rate of premature births. GlaxoSmithKline (GSK) last year stopped a late-stage clinical trial of its RSV vaccine in pregnant people over an elevated risk of premature birth...