FDA greenlights first vaccine for RSV prevention in infants via active gestational immunization

The Food and Drug Administration announced its approval of Pfizer’s Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease and severe LRTD caused by respiratory syncytial virus in infants from birth through six months of age. FDA says Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy. The approval follows a clinical study that confirmed Abrysvo’s effectiveness to prevent LRTD and severe LRTD caused by RSV in infants born to individuals who were vaccinated during pregnancy.