AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices | GSK Stock News

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Apr 16, 2025
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  • GSK's AREXVY vaccine recommended by ACIP for high-risk adults aged 50-59.
  • Targets 13 million adults in the US with conditions like COPD, asthma, diabetes, and heart disease.
  • RSV causes an estimated 42,000 hospitalizations annually in adults aged 50-64 in the US.

GSK's AREXVY (GSK, Financial) has received a positive recommendation from the US Advisory Committee on Immunization Practices (ACIP) for use in adults aged 50-59 who are at increased risk for severe respiratory syncytial virus (RSV) disease. This recommendation builds upon earlier guidance established in June 2024, which advocated for the vaccination of high-risk individuals aged 60-74 and all adults over 75.

The ACIP's recommendation is set to benefit more than 13 million American adults in the specified age group who are contending with underlying health conditions such as chronic obstructive pulmonary disease (COPD), asthma, diabetes, and heart disease, as well as those residing in care facilities. RSV poses a significant health threat, contributing to approximately 42,000 hospitalizations each year in adults aged 50-64 within the US.

This decision follows the successful completion of a phase III clinical trial that demonstrated the vaccine's efficacy and safety for this younger demographic. While this recommendation has been made, it awaits final approval. Once affirmed, the guidelines will be published to assist healthcare providers in the vaccination process and to inform insurance coverage decisions.

GSK's AREXVY vaccine, indicated for the prevention of lower respiratory tract disease caused by RSV, is currently approved for individuals aged 60 and over and those aged 50-59 at increased risk, in various countries including the US, EU, and Japan. This expansion in indication aims to address an unmet medical need by offering protection to a younger, more vulnerable population.

The expansion of the AREXVY vaccine's eligible population represents a significant advancement in public health strategy, targeting a group at elevated risk for severe outcomes from RSV. This aligns with a broader trend towards addressing RSV's impact across the adult lifespan and underscores a strategic focus on high-risk groups to optimize healthcare resource allocation.

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