GSK announces U.S. CDC AdCom votes to recommend Arexvy in RSV prevention

GSK “announced that the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, voted in favour of recommending the use of Arexvy in adults aged 60 and older using shared clinical decision making. Shared clinical decision making empowers patients in consultation with their healthcare providers to determine whether RSV vaccination is appropriate for them. There are an estimated 55.8 million people aged 65 and older in the US who are at increased risk of RSV, a common, contagious virus that can lead to serious respiratory illness. RSV causes approximately 177,000 hospitalisations and an estimated 14,000 deaths in this age group in the US each year. For adults 60 and older, data suggest an increased risk for severe RSV infection that can lead to hospitalisation. Older adults, including those with underlying medical conditions*, such as chronic heart disease, chronic lung disease or diabetes, are at high risk of severe RSV illness and account for the majority of RSV hospitalisations. In making its recommendation, the ACIP considered evidence from the comprehensive data package supporting the vaccine, including in older adults with underlying medical conditions. This includes results from the first season of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, published in the New England Journal of Medicine in February 2023. During the ACIP meeting, GSK also presented data from the Northern Hemisphere second season of the trial, which remains ongoing to explore the effect of the vaccine over multiple seasons and the optimal timing for potential revaccination. These data will be submitted to the US Food and Drug Administration (FDA) for review. The ACIP recommendations will be forwarded to the director of the CDC and the US Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR) to advise healthcare providers on appropriate use of the vaccine.”