European Commission Approves Pfizer's ABRYSVO Vaccine for RSV

The European Commission has granted marketing authorization for Pfizer's ABRYSVO vaccine, designed to protect against respiratory syncytial virus (RSV). The approval covers protection for infants through maternal immunization during pregnancy and for adults aged 60 years and older.

ABRYSVO is the first RSV vaccine approved in the EU for both older adults and for immunizing pregnant individuals to help protect their infants from birth through six months of age. The authorization is valid across all 27 EU member states, plus Iceland, Liechtenstein, and Norway.

The decision follows positive opinions from the Committee for Medicinal Products for Human Use (CHMP) and is based on findings from two Phase 3 clinical trials: RENOIR, which assessed the vaccine's efficacy and safety in adults 60 and older, and MATISSE, which evaluated the impact of maternal immunization on infant protection against RSV-induced lower respiratory tract disease.

RSV is a common and contagious virus that can cause severe respiratory illness. In the EU, RSV is associated with approximately 245,000 yearly hospital admissions in children under five, with most cases occurring in infants. Among adults 60 and older, RSV leads to over 270,000 hospitalizations and around 20,000 deaths annually.