‘Turning point’: World’s first RSV vax approved
GSK's Arexvy vaccine is 83% effective at preventing lower respiratory tract disease in over-60s, its phase III trial suggests.
The world’s first respiratory syncytial virus vaccine has been approved by the US medicines regulator for older adults.
Approval of GSK’s protein-based vaccine, dubbed Arexvy, followed phase III trial results showing 83% efficacy in preventing respiratory syncytial virus (RSV)-associated lower respiratory tract disease, compared with placebo.
The study involving 25,000 patients (mean age 70) also demonstrated that a single dose had an efficacy of 94% against severe lower respiratory tract disease, and 72% against acute respiratory infection.
Arexvy was deemed equally effective in the 60-69 and 70-79 age groups, as well as in those with comorbidities, including COPD and chronic heart failure.
