(Aug. 25, 2023) – On Aug. 21, the Food and Drug Administration expanded approval of Pfizer's Abrysvo (respiratory syncytial virus vaccine), to include 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. Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy and is administered as a single-dose intramuscular injection. The FDA previously approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older. In infants and children, the risk of RSV-associated LRTD is highest during the first year of life.
According to the Centers for Disease Control and Prevention, RSV is the leading cause of infant hospitalization in the U.S. The safety and effectiveness of Abrysvo for immunization of pregnant individuals to prevent LRTD and severe LRTD caused by RSV in infants from birth through six months of age was evaluated in ongoing, randomized, placebo-controlled international clinical studies. Among approximately 3,500 pregnant individuals who received Abrysvo, compared to approximately 3,500 pregnant individuals who received placebo, Abrysvo reduced the risk of severe LRTD by 81.8 percent within 90 days after birth, and 69.4 percent within 180 days after birth. For more information, see the FDA announcement and the Abrysvo prescribing information.
--Karen Braman