The European Commission has amended the marketing authorization for Pfizer’s ABRYSVO, expanding its use to individuals aged 18 through 59 years for the prevention of lower respiratory tract disease caused by respiratory syncytial virus. Previously approved for those aged 60 and older, ABRYSVO now holds the broadest RSV vaccine indication in the European Union. The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use and is based on the pivotal Phase 3 MONeT trial, which demonstrated the vaccine’s safety, tolerability, and immune response in adults with certain chronic conditions. The authorization, which also supports maternal immunization to protect infants up to six months of age, covers all EU member states as well as Iceland, Liechtenstein, and Norway.
Alexandre de Germay, Pfizer’s Chief International Commercial Officer and Executive Vice President, stated, “We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease, a common respiratory virus with symptoms that can be severe or even life-threatening.” ABRYSVO is a bivalent, unadjuvanted vaccine designed to offer protection against both major RSV subgroups. The vaccine had already secured approvals in the United States for different age groups and maternal immunization. Pfizer’s expanded indication for ABRYSVO in the EU aims to significantly reduce the burden of RSV across broader segments of the population in upcoming respiratory seasons.
