- Arexvy's approval will help protect adults 60 years of age and older in
- RSV causes an estimated 63,000 hospitalisations and 4,500 in-hospital deaths in adults 60 years of age and older in
- The approval - the first in
RSV is a common, contagious respiratory virus2 that causes an estimated 470,000 hospitalisations and 33,000 deaths each year in adults 60 years of age and older in industrialised countries, including approximately 63,000 hospitalisations and 4,500 deaths in Japan.3 Its impact on healthcare systems may further increase as the population ages. Those with underlying medical conditions, such as chronic heart disease, chronic lung disease or diabetes, account for the majority of RSV hospitalisations.4
The approval has been granted based on data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III vaccine efficacy trial, published in the
The vaccine was generally well tolerated. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache and arthralgia. These were generally mild to moderate and transient.
This is the fifth major regulatory approval for Arexvy, building on approvals from the
Respiratory syncytial virus vaccine, adjuvanted, contains recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK's proprietary AS01E adjuvant.
The MHLW has approved Arexvy for the prevention of RSV (respiratory syncytial virus) disease for adults aged 60 years and above. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Arexvy, the trade name approved in the US, EU/EEA,
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from
This is a randomised, placebo-controlled, observer-blind, multi-country phase III trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 vaccine in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries. Initial results were published in the
About respiratory syncytial virus (RSV) in adults
RSV is a common contagious virus affecting the lungs and breathing passages. Older adults are at high risk for severe disease. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death. Each year, RSV causes over 470,000 hospitalisations and 33,000 in-hospital deaths in adults 60 years of age and older in industrialised countries, including approximately 63,000 hospitalisations and 4,500 deaths in
Please refer to the updated Product Information (PI) for important dosage, administration, and safety information in
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 gsk.com.
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 under Item 3.D 'Risk factors" in the company's Annual Report on Form 20-F for 2022, and Q2 Results for 2023 and any impacts of the COVID-19 pandemic.
 Statistics Bureau Home Page/Population Estimates Monthly Report
 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", in Influenza Other Respir Viruses 2023;17(1):e13031. doi.org/10.1111/irv.13031
 Tseng HF, Sy LS, Ackerson B, et al., "Severe morbidity and short- and mid- to long-term mortality in older adults hospitalized with respiratory syncytial virus infection" in J Infect Dis. 2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361
(C) 2023 M2 COMMUNICATIONS, source