Also known as: severe RSV disease
The European Commission approved Enflonsia for prevention of RSV lower respiratory tract disease in infants during their first RSV season. Merck also reported new Phase 3 SMART data showing generally consistent second-season safety in high-risk children under 2 years old.
GSK's RSV vaccine Arexvy received expanded FDA approval to cover all high-risk adults, adding approximately 21 million Americans under 50 to the eligible population and matching competitor approvals from Pfizer and Moderna.
Merck announced positive second RSV season findings from the Phase 3 SMART trial evaluating ENFLONSIA (clesrovimab) in infants and children under 2 years at increased risk for severe RSV disease, showing consistent safety and antibody levels similar to healthy infants.
