GlaxoSmithKline (GSK) has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for its regulatory application to extend the indication of its respiratory syncytial virus (RSV) vaccine, Arexvy, for individuals aged 50 to 59 at increased risk.
The regulatory approval marks an expansion of the vaccine's use. It was previously authorised for senior citizens (aged 60 and above) in September 2023.
The decision by the MHLW is based on the Phase III trial outcomes, which demonstrated non-inferior immunogenicity in individuals aged 50 to 59 compared to those aged 60 and above.
The global trial included four clinical sites in Japan. Safety and reactogenicity profiles in the newly approved age group were consistent with the outcomes observed in the initial Phase III programme for older adults aged 60 and above.
Arexvy, the first RSV vaccine approved in the country for this age group, is currently authorised in the US and a further 35 countries.
The vaccine's active ingredient is a recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3), combined with GSK's AS01E adjuvant.
This adjuvant system includes STIMULON QS-21, licensed from Antigenics, a subsidiary of Agenus.
In November 2024, GSK secured approval for the vaccine in Canada for the prevention of lower respiratory tract disease caused by RSV in adults aged 50 to 59 at increased risk.
GSK chief scientific officer Tony Wood stated: "This approval reflects our ambition to protect people at increased risk from the severe consequences of RSV infection.
“Adults aged 50 to 59 with certain underlying medical conditions can face debilitating consequences from RSV, so we are pleased to offer those in Japan a vaccine for the first time.”
