FDA Approves Pfizer's RSV Vaccine for Infants Given to Pregnant Individuals

The U.S. Food and Drug Administration (FDA) has approved Pfizer's ABRYSVO™ vaccine for the prevention of medically attended lower respiratory tract illness (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants. The vaccine is administered through active immunization of pregnant individuals between 32 and 36 weeks of gestational age, providing protection to infants from birth up to six months old.

This approval marks the first and only maternal vaccine available in the U.S. to help protect newborns from RSV at birth through their first six months of life. The decision was based on data from the pivotal Phase 3 clinical trial, MATISSE, which involved over 7,000 pregnant individuals and their infants, totaling more than 14,000 participants. The study demonstrated a favorable safety and efficacy profile for the unadjuvanted, bivalent vaccine.

RSV is a common and contagious virus that can cause severe respiratory illness, particularly in young infants. In the United States, an estimated 500,000 to 600,000 infants experience LRTD due to RSV annually, making it a leading cause of hospitalization for children under one year of age.

Pfizer's ABRYSVO is designed to protect against both RSV A and B strains. The company also has an existing RSV vaccine approved for older adults.