• Adults aged 60 and over with underlying co-morbidities are at high risk of developing severe infections from RSV
• Vaccine showed 82.6% overall vaccine efficacy against RSV-LRTD with 94.6% efficacy observed in adults with co-morbidities ^vii

KUALA LUMPUR, Malaysia, Sept. 25, 2024 /PRNewswire/ -- 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. ⁱ 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. ^vii 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. ^vii

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. ⁱⁱ 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. ^vii

Since the COVID-19 pandemic, there has been an altered pattern of seasonal infections due to COVID-19 protection measures. ^iv Specifically in Malaysia, RSV infections occur all year round, with notable peaks typically occurring between July to August, as well as October to December. ^v

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."

About GSK's RSV older adult vaccine

GSK's RSV older adult vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant. Across multiple trials, the vaccine candidate was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, and headache. These were typically mild to moderate and transient.

About RSV in adults

RSV is a common contagious virus affecting the lungs and breathing passages. ⁱ Until now, it was a concerning infectious disease outcomes. Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. ⁱⁱⁱ RSV can exacerbate conditions, including COPD, asthma, and CHF, and can lead to severe outcomes, such as pneumonia. ⁱ In 2019, RSV causes over 470,000 hospitalisations and 33,000 deaths in adults aged 60 years and older in high-income countries. ⁱⁱⁱ Adults with underlying conditions are more likely to seek medical advice and have higher hospitalisation rates than adults without these conditions.

About GSK

GSK is a global biopharma company with the ambition and purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people over the next 10 years. Our bold ambitions for patients are reflected in new commitments to growth and a step-change in performance. We have been operating in Malaysia for over 65 years, since starting our first operations in October 1958. In the last six decades, GSK Malaysia has grown substantially both in its infrastructure, business operations as well as talent base. Currently operating with over 400 employees spread across our two business entities - Pharmaceuticals & Vaccines and Business Service Centre. Find out more at Malaysia | GSK.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022, and when issued GSK's Q3 Results for 2022, and any impacts of the COVID-19 pandemic.

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