The U.S. FDA approved Pfizer’s ABRYSVO (respiratory syncytial virus vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant women at 32 through 36 weeks gestational age. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains.

The FDA’s decision is based on data from the Phase 3 clinical trial MATISSE, designed to evaluate the efficacy, safety, and immunogenicity of the vaccine against LRTD and severe LRTD due to RSV in infants born to healthy individuals vaccinated during pregnancy.

RSV is a contagious virus and a common cause of respiratory illness worldwide. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.