GSK’s RSV Vaccine gains expanded approval in Japan for at-risk adults aged 50-59

UK—Global pharmaceutical leader GSK has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expanded use of its respiratory syncytial virus (RSV) vaccine, Arexvy.

This approval extends the vaccine’s indication to include adults aged 50-59 who are at increased risk of severe RSV-related illness. 

Previously, Arexvy was approved in Japan for adults aged 60 and above to prevent RSV-related disease, with the initial authorization granted in September 2023.

The latest decision marks a significant milestone in expanding protection to a broader age group with underlying health risks. 

RSV is a highly contagious virus that affects the lungs and respiratory system, impacting approximately 64 million people worldwide each year.

While RSV can affect people of all ages, adults with certain medical conditions, weakened immune systems, or those of advanced age are more vulnerable to severe outcomes.

These include complications such as pneumonia, exacerbation of chronic conditions like COPD and asthma, hospitalization, and even death. 

Commenting on the approval, Tony Wood, Chief Scientific Officer at GSK, emphasized the importance of safeguarding vulnerable populations.

He noted that adults aged 50-59 with underlying health conditions often face debilitating consequences from RSV.

“We are pleased to offer this vaccine to at-risk individuals in Japan for the first time,” he stated. 

The expanded approval is based on data from a global Phase III clinical trial, which included four sites in Japan.

The study demonstrated that the vaccine provided comparable immunogenicity—meaning the ability to stimulate an immune response—in adults aged 50-59 at increased risk of severe RSV compared to those aged 60 and older.

Additionally, the safety and tolerability of the vaccine in this age group were consistent with earlier findings in older adults. 

Globally, Arexvy has been approved for at-risk adults aged 50–59 in 35 countries, including the United States. Regulatory reviews are ongoing in other regions.

However, despite the vaccine’s potential, GSK recently noted that its overall vaccine sales might decline this year due to reduced demand for Shingrix in the U.S. and China, along with lower-than-expected RSV vaccine sales in the U.S. during the third quarter.

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