GlaxoSmithKline Pharmaceutical Sdn Bhd (GSK) today announced that Arexvy (MAL24086007ARZ) has been approved in Malaysia for RSV, a common respiratory virus that can lead to serious negative clinical outcomes, such as lower respiratory tract disease (LRTD) and pneumonia in older adults. The RSV vaccine has been approved for older adults aged 60 and above in the country. This adjuvanted vaccine can transform efforts to reduce RSV’s burden on older adults, the healthcare system and society.
The approval is based on positive data from a phase III trial, where the vaccine demonstrated high overall vaccine efficacy of 82.6% against LRTD. vii 94.6% efficacy was observed against RSV-LRTD in adults with co-morbidities. Across multiple studies, the vaccine was generally well tolerated with an acceptable safety profile. Some adverse events observed were injection site pain, fatigue, myalgia, and headache. These were typically mild to moderate and lasting within a few days after vaccination.
Whilst, RSV is a disease of all ages, in 2019, the impact of RSV in adults aged 60 years and older is significant, resulting in over 470,000 hospitalisations and 33,000 deaths in high-income countries. Adults with underlying co-morbidities, including chronic obstructive pulmonary disease (COPD), asthma, diabetes, and chronic heart failure (CHF) are at high risk for severe RSV.
Since the COVID-19 pandemic, there has been an altered pattern of seasonal infections due to COVID-19 protection measures. Specifically in Malaysia, RSV infections occur all year round, with notable peaks typically occurring between July to August, as well as October to December.
Professor Dr Ahmad Izuanuddin Ismail, Deputy Director & Consultant, Respiratory Physician Hospital Al Sultan Abdullah Universiti Teknologi MARA (HASA UiTM) shared: “RSV can lead to severe outcomes especially among older adults with co-morbidities such as Asthma, COPD and chronic heart failure. iii They also have increased risk of hospitalization following the RSV infection. iii It is important for us to protect patients aged 60 and above with co-morbidities. In Malaysia, according to the 2023 National Health Morbidity Survey (NHMS), more than half a million adults live with four co-morbidities. vi Of these, 15.6% of the adult population have Diabetes. vi It is time we protect our older adults with underlying health conditions from RSV infection to enable them to lead a good quality of life especially in their golden age. By prioritizing the well-being of older adults, we can collectively foster a healthier and more vibrant society, ultimately enhancing the quality of life for all generations.”
Dr. Alap Gandhi, Country Medical Director of GlaxoSmithKline Pharmaceutical Sdn Bhd (GSK) Malaysia and Brunei said: “Today’s announcement is a major step forward from a public health perspective as it allows us to deliver an RSV vaccine in Malaysia to protect older adults. We look forward to working with various stakeholders to ensure those at high risk of severe RSV infection can access it.”