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Japan has become the 36th country to approve GSK’s respiratory syncytial virus (RSV) vaccine (Arexvy) for use in adults aged 50-59 years at increased risk.

This comes only 14 months after the country’s regulatory authorities approved the vaccine’s use in those above 60 years of age for prevention of the virus.

The approval for this new age group is based on data from a phase III clinical trial conducted across 4 sites in Japan which found that use of Arexvy in individuals aged 50-59 years elicited comparable immunogenicity to that seen in those over 60 years old.

Effectively achieving non-inferior efficacy between the two cohorts.

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Annually, an estimated 64 million people are affected by RSV, a widespread infectious virus that affects the lungs and breathing airways. Adults who have specific underlying medical disorders, weakened immune systems, or advanced age may be more susceptible to RSV disease.

An RSV infection can cause serious consequences like pneumonia, hospitalization, and death, as well as worsen existing illnesses like COPD, asthma, and chronic heart failure.

"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." 

 

Tony Wood, Chief Scientific Officer at GSK.

The 50-59 at-risk population's safety and reactogenicity were in line with the findings of the first phase III program for persons 60 years of age and older.

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