GSK has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) RSV vaccine for the 50-59 age group.
The vaccine is now approved for individuals in the age group who are at increased risk of severe respiratory syncytial virus (RSV) disease in Japan.
Arexvy, which has been approved since September 2023 for individuals aged 60 and older, now extends its coverage to adults aged 50–59 at increased risk. The latest approval is driven by positive results from a global Phase 3 trial, including data from four clinical sites in Japan.
The trial demonstrated that Arexvy provided non-inferior immunogenicity in adults aged 50-59 compared to those aged 60 and older. The safety and reactogenicity profiles were found to be consistent with results from the initial Phase 3 programme in adults aged 60 and older.
GSK’s RSV vaccine is now approved for high-risk adults aged 50-59 in 35 countries, including the US, with ongoing regulatory reviews in other regions.
GSK chief scientific officer Tony Wood said: “This approval reflects our ambition to protect people at increased risk from the severe consequences of RSV infection.
“Adults aged 50-59 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.”
The RSV vaccine contains recombinant RSV glycoprotein F in its prefusion conformation (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant.
The AS01 adjuvant system includes STIMULON QS-21, licensed from Antigenics, a subsidiary of Agenus. STIMULON is a trademark of SaponiQx, which is also a subsidiary of Agenus.
Recently, the vaccine was approved in Canada for preventing lower respiratory tract disease (LRTD) caused by RSV in adults aged 50-59 at increased risk.
