The European Commission (EC) has authorised GSK’s Arexvy for active immunisation against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50 to 59 years.
The recombinant adjuvanted RSV vaccine is indicated for adults at increased disease risk.
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The vaccine has been available for adults over 60 years since June 2023.
People with heightened risk due to underlying medical conditions such as chronic obstructive pulmonary disease, asthma, heart failure and diabetes are eligible for the vaccine.
RSV is known to exacerbate existing medical conditions, potentially resulting in pneumonia, hospitalisation or even death.
The regulatory approval for the expanded age indication was supported by positive outcomes from a Phase III trial that evaluated the immune response and safety of the vaccine in the target age group, including those with certain underlying medical conditions.
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By GlobalDataGSK has also sought to extend the use of Arexvy to the same age group in other regions, including Japan.
Regulatory decisions in these geographies are currently under review.
In June 2024, the US Food and Drug Administration (FDA) expanded the age indication for GSK‘s Arexvy for adults aged 50 to 59 years at higher LRTD risk.
Further clinical trials are underway to assess the vaccine’s efficacy in adults aged 18 to 49 at increased risk, and immunocompromised adults aged 18 years and over, with results expected in 2024.
GSK chief scientific officer Tony Wood stated: “The approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50 to 59 who are at increased risk.
“RSV infection can have a significant impact on the health of older adults and particularly those with certain existing medical conditions, which can add pressure onto healthcare systems. As we enter the RSV season, we are pleased to be the first to deliver a vaccine to help protect more people in Europe from RSV-LRTD.”
