FDA Expands Approval of GSK’s RSV Vaccine to Include At-Risk Adults Aged 50-59

1. Expanded FDA Approval: The FDA has granted approval for GSK's Arexvy RSV vaccine for use in adults aged 50-59 with underlying health conditions, marking the first time an RSV vaccine has been approved for this age group.
2. At-Risk Population: Approximately 13 million adults in the US aged 50-59 have medical conditions that increase their risk of severe RSV outcomes, including chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes.
3. Safety Profile: The safety profile of Arexvy in adults aged 50-59 is consistent with that in older adults, with fewer than 10% experiencing adverse reactions, primarily injection site pain, fatigue, muscle ache, and headache.
4. Efficacy: A single dose of Arexvy elicited an immune response in adults aged 50-59 that was not inferior to that observed in individuals 60 and above, with efficacy rates of 83% against lower respiratory tract disease and 94% against severe disease.
5. Future Trials: GSK is planning trials to evaluate the vaccine's safety and immunogenicity in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over, with data expected in the second half of 2024.