HSA approves GSK's Arexvy, the world's first respiratory syncytial virus (RSV) vaccine for older adults [1]

· Arexvy has been approved by the Health Sciences Authority (HSA) of Singapore for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.^[2]
· Arexvy is 94.6% efficacious in preventing LRTD caused by RSV in older adults aged 60 years or over and with at least one underlying medical condition, such as cardiorespiratory and endocrine-metabolic (including asthma, COPD, diabetes, chronic heart failure, among others).^[8]
· Arexvy is the first RSV vaccine approved in Singapore.

SINGAPORE, May 16, 2024 /PRNewswire/ -- Arexvy has been approved by the Health Sciences Authority (HSA) of Singapore for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.^[2] The first respiratory syncytial virus (RSV) vaccine in the world^[1] and the first RSV vaccine approved in the country, Arexvy (recombinant, AS01E adjuvanted) further strengthens the company's portfolio of vaccines aimed to protect older adults in Singapore from a variety of infectious diseases.

"Our RSV vaccine has been over 60 years in the making^[3] – we are proud to bring this vaccine to the over one million older adults aged 60 years or above in Singapore^[4]. With our growing adult vaccine portfolio, we continue to deliver on our commitment to disease prevention in line with healthier ageing for the people of Singapore," said Raakhi Sippy, Vice President & General Manager, GSK Singapore.

In 2019, RSV infection accounted for an estimated 5.2 million cases of acute respiratory infection, 470,000 hospitalisations and 33,000 in-hospital deaths among adults 60 years of age or over in industrialised countries.^[5] In a four-year study in Singapore, one out of every 20 older adults aged 65 years or over has tested positive for RSV.^[6]

RSV is a common, contagious virus that affects the lungs and respiratory airways.^[7] The virus can affect all ages and could be often similar to other acute respiratory infections, like colds or influenza, including a blocked nose, cough, fatigue, fever, sore throat, runny nose, body aches and headache, and a test is needed to confirm a diagnosis.^[7] But the impact of RSV in those over 60 years of age is significant.^[6]

RSV among older adults aged 60 years or over and with an underlying medical condition could even be more serious.^[7] They have a greater risk of being hospitalised from RSV compared to those without these conditions.^[7] In this group of people, RSV can cause lower respiratory tract disease, which may lead to exacerbation of these underlying diseases, hospitalisation and death.^[7]GSK Asia House, Singapore

Data from the AReSVi-006 Phase III trial showed efficacy of 94.6% for Arexvy in preventing LRTD caused by RSV in older adults aged 60 years or over and with at least one underlying medical condition of interest, that includes cardiorespiratory and endocrine-metabolic (such as asthma, COPD, diabetes, congestive heart failure, among others).^[8] Overall, in adults aged 60 years or over, the vaccine demonstrated high vaccine efficacy of 82.6% against LRTD caused by RSV.^[8]

"People aged 60 years or over could be our parents, grandparents, uncles or aunts, whom we live with at home - and they could be exposed to RSV. By 2030, one in four Singaporeans are expected to be over 65 years of age.^[12] This indicates a large cohort who could be at risk for RSV. The downstream costs and burden on the healthcare system and economy will further increase as the population ages," said Dr. Stephanie Cinthu Stephen Ambrose, Country Medical Director, GSK Singapore.

"As we move towards being a 'super-aged' society, there is a clearer need to prioritise prevention of infectious diseases, like RSV, and keep our older adults healthy as they enjoy their golden years," Dr. Ambrose added.Representation of the respiratory syncytial virus (RSV Virus)

*About RSV in older adults, 60 years of age or over*

RSV is a common contagious virus affecting the lungs and breathing passages. For adults 60 and older, data suggest an increased risk for severe RSV infection that can lead to hospitalisation.^[7] Older adults are at high risk for severe disease due in part to age-related decline in immunity, and older adults with underlying conditions are at even greater risk for severe disease^[7]. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD)^[9], asthma^[14], diabetes^[10] and congestive heart failure^[11] and can lead to severe outcomes, such as pneumonia, hospitalisation, and death^[7].

*About GSK's Arexvy - Respiratory syncytial virus vaccine*

GSK's RSV older adult vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant.^[13]In Singapore, Arexvy is indicated to protect against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and over^[3]. The vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in Europe, Japan, UK, Canada, Australia, Hong Kong, Taiwan and several other countries and regions. Regulatory reviews in multiple countries are ongoing. The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.

*About AReSVi-006*

The AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial is a randomised, placebo-controlled, observer blind, multi-country trial to demonstrate the efficacy of a single dose of GSK's RSV vaccine in adults aged 60 years and above. 24,996 participants enrolled in the study from 17 countries, including UK, US, Australia and Japan.^[8]

*About GSK *

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at https://www.gsk.com/en-gb/locations/singapore/

*REFERENCES:*

[1]: FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine | FDA. 3 May 2023.

[2]. Singapore Local Prescribing Information for Arexvy PI version GDS02/IPI01(SI)

[3]. Blanco et al. "New Insights for Development of a Safe and Protective RSV Vaccine - PMC (nih.gov)." Hum Vaccin. 2010 October 27; 6(6): 482–492.

[4]. Data from Singapore Department of Statistics (DOS) website https://www.singstat.gov.sg/

[5]. Savic M et al. "Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: A systematic literature review and meta-analysis." Influenza Other Respi Viruses;2022;1–10.

[6]. Ang, Li Wei et al. "Characterisation of respiratory syncytial virus activity in children and adults presenting with acute respiratory illness at primary care clinics in Singapore, 2014-2018." Influenza and other respiratory viruses vol. 14,4 (2020): 412-419. doi:10.1111/irv.12730

[7]. CDC. "RSV in Older Adults and Adults with Chronic Medical Conditions." Centers for Disease Control and Prevention, 14 July 2023, www.cdc.gov/rsv/high-risk/older-adults.html. Accessed 30 Aug. 2023

[8]. Papi A et al. "Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults." N Engl J Med 2023;388(7):595–608.

[9]. Tseng HF et al. "Severe Morbidity and Short- and Mid- to Long-term Mortality in Older Adults Hospitalized with Respiratory Syncytial Virus Infection." J Infect Dis 2020;222:1298–310.

[10]. American Diabetes Association Professional Practice Committee. Diabetes Care 2024;47(Supplement_1):S1–S4

[11]: Branche AR et al. "Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017-2020." Clin Infect Dis 2022:74:1004–1011.

[12]. MOH Leads Review to Strengthen Caregiver Support for Seniors. October 2018. MOH | News Highlights

[13]. Leroux-Roels I et al. "Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial." J Infect Dis. 2023;227:761–772.

[14]. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2024. Updated May 2024. Available from: www.ginasthma.org