The U.S. Food and Drug Administration (FDA) approved Abrysvo, a Respiratory Syncytial Virus (RSV) vaccine, the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age. Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy. Abrysvo is administered as a single-dose injection into the muscle. RSV is the leading cause of infant hospitalization in the U.S. The Prescribing Information for Abrysvo includes a warning to inform that a numerical imbalance in preterm births in Abrysvo recipients (5.7%) occurred compared to those who received a placebo (4.7%). The warning informs healthcare providers that to avoid the potential risk of preterm birth with the use of Abrysvo before 32 weeks of gestation, administer Abrysvo as indicated in pregnant individuals at 32 through 36 weeks of gestational age.
