World's first RSV vaccine approves

The Food and Drug Administration has approved the first-ever respiratory syncytial virus (RSV) vaccine, Arexvy, developed by GSK. The single-dose shot is designed to protect people aged 60 and older from lower respiratory tract disease caused by RSV, a highly contagious virus that can be severe in older people and young children. The vaccine has been shown to reduce the risk of severe RSV-associated LRTD by 94% and RSV-associated LRTD by 83%, according to data from a clinical trial. The vaccine is expected to be available to eligible seniors in the US before the RSV season, which begins in the autumn.

About Arexvy (respiratory syncytial virus vaccine, adjuvanted)

Respiratory syncytial virus (RSV) vaccine, adjuvanted, which is developed by GlaxoSmithKline (GSK), contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant. It is indicated for the prevention of RSV-LRTD in individuals 60 years of age and older in the US, and is not yet approved anywhere else in the world. The proposed trade name is subject to regulatory approval outside the US. Clinical trials are ongoing to expand the population who may benefit from RSV vaccination into adults aged 50-59, with results expected in 2023. The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc.

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RSV in adults:

Respiratory syncytial virus (RSV) is a contagious virus that affects the lungs and respiratory system. Older adults are at high risk of severe disease due to age-related decline in immunity, particularly those with underlying conditions like chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure. RSV can worsen these conditions and result in severe outcomes, including pneumonia, hospitalization, and death. In the US, approximately 177,000 adults aged 65 and older are hospitalized each year due to RSV, with an estimated 14,000 cases resulting in death. Data suggest that adults 60 and older are at increased risk for severe RSV infection leading to hospitalization, especially those with underlying conditions.