Respiratory syncytial virus (RSV) is a significant cause of lower respiratory tract disease (LRTD) in adults, particularly those with underlying health conditions. GSK has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approval of GSK’s RSV vaccine, Arexvy, to include adults aged 50-59 at increased risk for respiratory syncytial virus disease. This recommendation, a notable milestone, marks the first time CHMP has suggested this age group for an RSV vaccine, signaling a crucial step towards the extension of the marketing authorization by the European Commission, with a final decision expected by September 2024.
Arexvy, a recombinant adjuvanted RSV vaccine, has been approved in Europe since June 2023 for adults aged 60 and above for preventing RSV-LRTD. Expanding this approval to include adults aged 50-59 at increased risk would significantly impact public health. Adults with chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes are particularly vulnerable to severe consequences from respiratory syncytial virus infections. These conditions can be exacerbated by RSV, leading to pneumonia, hospitalization, or even death.
The CHMP’s recommendation underscores the vaccine’s potential to provide significant public health benefits by preventing RSV-related LRTD in a broader age range. This expansion is particularly important given the increased vulnerability of adults with underlying health conditions who face heightened risks from RSV infections.
In conclusion, the positive CHMP opinion on expanding the approval of GSK’s Arexvy to include adults aged 50-59 at increased risk represents a significant advancement in the fight against respiratory syncytial virus. This decision, pending final approval by the European Commission, highlights the importance of addressing the needs of at-risk populations and underscores the ongoing efforts to improve public health outcomes through vaccination. With regulatory reviews ongoing in multiple countries, Arexvy continues to pave the way for broader protection against RSV, reinforcing GSK’s commitment to innovation and patient care. As the final decision from the European Commission approaches, the potential impact of this expanded approval on public health and the well-being of at-risk adults in Europe is immense.
Resource: Glaxo Smith Kline, July 29, 2024

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