FDA Approves Arexvy (respiratory syncytial virus vaccine, adjuvanted) Respiratory Syncytial Virus (RSV) Vaccine for Older Adults
GSK has announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world.
RSV is a common, contagious virus that can lead to potentially serious respiratory illness. It causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in the US, in adults aged 65 years and older each year. Older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at increased risk of severe RSV illness and drive the majority of RSV hospitalizations.
The vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to moderate and transient.
In June 2023, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the US. The vaccine will be available for older adults before the 2023/24 RSV season, which typically starts ahead of the winter months.