The TGA is weighing up Australia’s first potential respiratory syncytial virus vaccine, while the US regulator has given preliminary approval to two vaccine candidates, as the RSV vaccine race tightens.  

GSK Australia lodged applied to the TGA for approval of protein-based vaccine Arexvy this year, following positive results from its phase III clinical trial. 

Findings published in The New England Journal of Medicine last month showed it was 83% effective in preventing respiratory syncytial virus (RSV)-related lower respiratory tract disease in over-60s compared with placebo — regardless of virus subtype.

The trial involving some 25,000 participants (mean age 70) also demonstrated vaccine efficacy of 94.1% against severe lower respiratory tract disease and 71.7% against RSV-related acute respiratory infection.