Japan

RSV Vaccination for Older Adults in Japan

RSV is increasingly recognized as a significant respiratory pathogen causing severe illness in older adults in Japan. Global RSV vaccines (Arexvy, Abrysvo, mRESVIA) have shown robust efficacy against lower respiratory tract disease and hospitalization in adults aged 60 and older. Japan’s aging population (29% aged 65+) faces increased risk from RSV infection, amplifying demand for effective preventive interventions.⁶

Experts forecast that RSV vaccines will become part of seasonal adult immunization campaigns similar to influenza and COVID-19 vaccines. The concept of “forced seasonality” could emerge, requiring healthcare providers in Japan to manage more clustered vaccination schedules across respiratory viruses.

Japan’s immunization policy landscape, focusing on vaccine equity and life-course coverage, is expected to prioritize RSV vaccination among older adults, particularly those at higher risk with chronic conditions.

Japan has made significant strides in RSV adult immunization with the approval of Arexvy, the first respiratory syncytial virus vaccine available in Japan for adults. Arexvy, an adjuvanted recombinant RSV prefusion F glycoprotein vaccine developed by GSK, received regulatory approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) in September 2023 for adults aged 60 and older for the prevention of RSV disease.⁷

In late 2024, the indication for Arexvy was expanded to include adults aged 50–59 who are at increased risk of severe RSV disease due to underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure.⁸ This regulatory expansion was supported by positive results from a global Phase III trial—

including four clinical sites in Japan—that demonstrated non-inferior immunogenicity and comparable safety of the vaccine in the 50–59 age group compared to older adults.

Further advancing RSV vaccine use, as of mid-2025, Japan’s MHLW has accepted a regulatory application to expand Arexvy’s use to adults aged 18–49 at increased risk of severe RSV disease, pending approval.⁹ If authorized, this would make Arexvy the first RSV vaccine available for this younger adult at-risk population in Japan, broadening protection across adult age groups.

RSV remains a major respiratory pathogen impacting millions annually worldwide, with older adults and those with comorbidities facing increased risk of severe outcomes, including pneumonia, hospitalization, and death.¹⁰ Japan’s aging population (29% aged 65+) is particularly vulnerable to RSV, emphasizing the importance of integrating RSV vaccination into adult immunization programs.¹¹

Arexvy’s approval and ongoing label expansion mark critical steps in Japan’s efforts to reduce RSV disease burden in adults through vaccination supported by robust clinical evidence. As Japan continues to incorporate new adult vaccines into its healthcare system, RSV vaccine rollout focusing on higher-risk adult populations is expected to contribute significantly to respiratory disease prevention.

This first phase of our work focuses on RSV. Additional disease areas will be added as the dataset and analysis continue to expand.