GSK’s Arexvy vaccine for RSV is approved for Malaysian seniors

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GlaxoSmithKline (GSK) announced that Arexvy (MAL24086007ARZ) has been approved in Malaysia for RSV (respiratory syncytial virus). The RSV vaccine has been approved for older adults aged 60 and above.

First identified in humans in 1956, RSV is a common respiratory virus that affects all ages. While younger and healthier people may fully recover from an infection, it can be particularly devastating for those aged over 60 and those with underlying co-morbidities.

In Malaysia, the estimated case fatality rate in older adults is between 9% to 11%

RSV infection and fatality rates in Malaysia — Professor Dr Ahmad Izuanuddin Ismail presenting infection and fatality estimates

Locally, the estimated annual incidence of RSV in adults aged 65 years and older is 142.3 – 294.3 per 100,000 Malaysians, with fatality estimated at 9% – 11%. Specifically in Malaysia, RSV infections occur all year round, with notable peaks typically occurring between July to August, as well as October to December.

In adults over 60, an infection can lead to serious negative effects, such as lower respiratory tract disease (LRTD) and pneumonia. Adults with underlying co-morbidities, including chronic obstructive pulmonary disease (COPD), asthma, diabetes, and chronic heart failure (CHF) are also at high risk for severe RSV.

Professor Dr Ahmad Izuanuddin Ismail, Deputy Director & Consultant, Respiratory Physician Hospital Al Sultan Abdullah Universiti Teknologi MARA (HASA UiTM) shared:

“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. Of these, 15.6% of the adult population have Diabetes.”

Arexvy is the first RSV vaccine in the world

Dr. Alap Gandhi, Country Medical Director of GSK Malaysian and Brunei

Named as one of the top 200 inventions of 2023 by Time Magazine, the vaccine is the only safeguard against RSV, which has no specific treatment.

The vaccine’s approval is based on positive data from a phase III trial, where the vaccine demonstrated high overall vaccine efficacy of 82.6% against LRTD. Meanwhile, 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 side events observed were injection site pain, fatigue, myalgia, and headache. These were typically mild to moderate and lasting within a few days after vaccination. The vaccine is single-dose, and only meant for those aged 60 and above.

Arexvy will be available in October, and you can visit your healthcare provider for more information.