ACIP recommends GSK’s Arexvy for 50-59 year olds with risk factors

USA—GSK plc has announced that the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has voted unanimously to recommend the use of respiratory syncytial virus (RSV) vaccines. 

These vaccines includes  GSK’s Arexvy, for adults aged 50 to 59 who are at increased risk for severe RSV-associated lower respiratory tract disease (LRTD).

This decision marks a significant expansion of the current vaccination guidelines, which previously focused on adults aged 60 and above, particularly those at higher risk and all adults aged 75 and older.

The ACIP’s new recommendation comes just months after the U.S. Food and Drug Administration (FDA) broadened the approval of Arexvy to include adults in the 50-59 age group who have underlying health conditions that put them at higher risk for severe RSV disease.

These conditions include chronic obstructive pulmonary disease (COPD), asthma, diabetes, heart disease, obesity, and immunocompromising conditions, as well as residency in long-term care facilities.

RSV is a highly contagious virus that can cause mild, cold-like symptoms in healthy individuals but can lead to severe illness, hospitalization, or even death in those with chronic health problems.

 According to the CDC, each year in the U.S., RSV is responsible for an estimated 15,000 to 20,000 hospitalizations among adults aged 50 to 59, with the highest risk seen in people who have the aforementioned underlying conditions.

 A broader systematic review suggests that the number of hospitalizations in adults aged 50 to 64 may be as high as 42,000 annually, likely due to under-detection in some cases.

RSV infection can worsen existing health problems, such as triggering asthma attacks, exacerbating COPD, or leading to complications like pneumonia and heart failure.

This can result in increased hospitalizations and, in severe cases, death, especially among those with chronic illnesses.

Tony Wood, Chief Scientific Officer at GSK, expressed satisfaction with the ACIP’s decision, noting that this move could benefit more than 13 million adults in the U.S. aged 50-59 who are at increased risk for severe RSV outcomes.

 He emphasized RSV’s significant impact on individuals with underlying medical conditions and highlighted the importance of expanding vaccine protection to this broader group.

The ACIP’s recommendation was informed by positive results from a phase III clinical trial, which evaluated the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at higher risk due to underlying conditions.

The trial demonstrated that the vaccine is effective after a single dose, similar to results seen in older adults.

It is important to note that while the ACIP has voted in favor of this expanded recommendation, it is not yet final.

The recommendation will undergo further review and, once approved, will be published in the CDC’s Morbidity and Mortality Weekly Report.

This publication will provide guidance to healthcare providers on the appropriate use of the vaccine and inform insurance coverage decisions.

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