GlaxoSmithKline Pharmaceutical Sdn Bhd (GSK)  announced the approval of Arexvy (MAL24086007ARZ) in Malaysia, a groundbreaking vaccine developed to protect older adults from respiratory syncytial virus (RSV), a common respiratory infection that can lead to severe health outcomes, including lower respiratory tract disease (LRTD) and pneumonia. The vaccine is now available for adults aged 60 and above, particularly those with underlying co-morbidities such as asthma, chronic obstructive pulmonary disease (COPD), diabetes, and chronic heart failure (CHF), who are at high risk for severe RSV-related infections.

Addressing Unmet Needs in Older Adults with Co-morbidities
In Malaysia, RSV infections present a significant year-round challenge, with peaks in the July-August and October-December periods. This vaccine comes at a crucial time, offering older adults vital protection against severe RSV outcomes, especially those living with chronic conditions. Recent data from the 2023 National Health Morbidity Survey (NHMS) shows that over half a million adults in Malaysia live with four or more co-morbidities, heightening their vulnerability to serious infections like RSV.

The approval of Arexvy is supported by robust data from a Phase III clinical trial, demonstrating 82.6% overall efficacy against RSV-LRTD and an even higher efficacy of 94.6% in adults with co-morbidities. The vaccine has proven well-tolerated, with mild to moderate side effects such as injection site pain, fatigue, and headache, which typically resolve within a few days.

Expert Insights
Professor Dr. Ahmad Izuanuddin Ismail, Deputy Director & Consultant Respiratory Physician at Hospital Al Sultan Abdullah Universiti Teknologi MARA (HASA UiTM), emphasized the importance of protecting vulnerable older adults: "RSV can cause severe health impacts, particularly among those with co-morbidities like COPD, asthma, and CHF. By prioritizing vaccinations for these at-risk groups, we can significantly reduce hospitalizations and improve their quality of life in their golden years."

A Major Milestone for Public Health
Dr. Alap Gandhi, Country Medical Director of GSK Malaysia and Brunei, expressed the significance of this approval: "Today’s announcement marks a major step forward in protecting older adults from RSV infections. We look forward to collaborating with healthcare stakeholders to ensure those most vulnerable can access this critical vaccine."