The U.S. Food and Drug Administration (FDA) has authorized Pfizer's bivalent RSV prefusion F (RSVpreF) vaccine, ABRYSVO, for wider use in protecting people 18 to 59 years of age who are more susceptible to RSV-related lower respiratory tract disease. ABRYSVO now provides the widest RSV vaccine indication for adults, having previously only been authorized for use in people 60 years of age and older and for maternal vaccination to protect babies. The MONeT Phase 3 clinical study, which evaluated safety, immunogenicity, and tolerability in high-risk people with chronic illnesses like obesity, diabetes, and COPD, served as the foundation for this latest approval.
ABRYSVO, which is unadjuvanted and bivalent, provides comprehensive protection against both major RSV subgroups, RSV-A and RSV-B, by targeting the RSV fusion protein in its prefusion state. With this approval, Pfizer becomes the only company with an RSV vaccine indicated for multiple high-risk groups, including older adults, pregnant individuals, and younger adults with chronic conditions. Pfizer’s commitment to health extends globally, with ABRYSVO authorized in several countries and maternal immunization recommendations in place across Europe. This development aligns with Pfizer’s mission to leverage scientific innovation to meet global healthcare needs, improve access, and enhance disease prevention.
