GSK plc has disclosed that Japan’s Ministry of Health, Labour and Welfare (MHLW) authorized a regulatory application to broaden the use of Arexvy, the recombinant adjuvanted RSV vaccine, to include adults between 50-59 who are at a higher risk of severe RSV disease. Since September 2023, Japan has sanctioned GSK’s RSV vaccine for individuals aged 60 and above to prevent RSV disease.
GSK’s Chief Scientific Officer, Tony Wood, remarked, “This approval aligns with our goal to safeguard those at increased risk from the severe effects of RSV infection. Adults aged 50-59 with specific underlying health concerns can suffer grave consequences from RSV; hence, we’re thrilled to introduce this vaccine to Japan for the first time.”
RSV, a prevalent infectious virus, primarily targets the lungs and respiratory tract, affecting around 64 million individuals worldwide every year. Certain underlying health issues, compromised immune systems, or advanced age can elevate an adult’s risk of RSV disease. RSV infection might intensify conditions such as COPD, asthma, and chronic heart failure, potentially resulting in severe outcomes like pneumonia, hospitalization, or death.
This approval for expanded use is bolstered by results from a global phase III trial, which included four clinical sites in Japan. The trial demonstrated equivalent immunogenicity in high-risk adults aged 50-59 compared to adults aged 60 and above for RSV lower respiratory tract disease. The safety and side effect profile in the 50-59 age group remained consistent with the initial phase III results for older adults.
Currently, GSK’s RSV vaccine has secured approval for usage among at-risk adults aged 50-59 across 35 nations, including the USA, with numerous regulatory assessments ongoing elsewhere.
The vaccine, Arexvy, featuring adjuvanted recombinant technology, incorporates recombinant RSV glycoprotein F stabilized in its prefusion form (RSVPreF3), paired with GSK’s AS01E adjuvant.
In September 2023, the MHLW confirmed GSK’s RSV vaccine for preventing the disease among adults 60 and above in Japan. Usage should follow official guidelines, and an adequate immune response may not develop in every vaccinated individual.
GSK utilizes the AS01 adjuvant system, which includes STIMULON QS-21, an adjuvant licensed from Antigenics Inc., a division of Agenus Inc. STIMULON is a registered trademark of SaponiQx Inc., under the Agenus umbrella.
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