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

GSK plc  announced that the Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the use of RSV vaccines including GSK’s Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care. This expands on ACIP’s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older.

A systematic review of studies in the US shows that RSV is estimated to cause 42,000 hospitalisations each year in adults aged 50-64 years old. Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation, or death.

In making its recommendation, the ACIP considered positive results from a phase III trial [NCT05590403] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions compared to older adults aged 60 years and above where efficacy has been demonstrated after a single dose of GSK’s RSV vaccine. (see citation).

Tony Wood, Chief Scientific Officer, GSK: “We are pleased with ACIP's recommendation to expand the benefits of RSV immunisation to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus. RSV can have a significant impact for those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination.”

See citation- M. Ferguson et al .Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age. Clini Infect Dis 2024, 79:1074 doi: 10.1093/cid/ciae364.