The potential public health impact of the respiratory syncytial virus prefusion F protein vaccine in people aged ≥60 years in Japan: results of a Markov model analysis

ABSTRACT

Background

Respiratory syncytial virus (RSV), a common respiratory pathogen, can lead to severe symptoms, especially in older adults (OA). A recently developed RSV prefusion F protein (RSVPreF3 OA) vaccine confers high protection against RSV lower respiratory tract disease (LRTD) over two full RSV seasons. The aim of this study was to assess the potential public health impact of RSVPreF3 OA vaccination in the Japanese OA population.

Research design and methods

A static Markov model was used to estimate the number of symptomatic RSV cases, hospitalizations and deaths in the Japanese population aged ≥ 60 years over a 3-year time horizon. Japan-specific RSV epidemiology and healthcare resource use parameters were used; vaccine efficacy was derived from a phase 3 randomized study (AReSVi-006, NCT04886596). Vaccination coverage was set to 50%.

Results

Without vaccination, >5 million RSV acute respiratory illness (ARI) would occur (2.5 million LRTD and 2.8 million upper respiratory tract infections) leading to ~ 3.5 million outpatient visits, >534,000 hospitalizations and ~ 25,500 RSV-related deaths over 3 years. Vaccination could prevent > 1 million RSV-ARI cases, 728,000 outpatient visits, 143,000 hospitalizations and 6,840 RSV-related deaths.

Conclusions

RSVPreF3 OA vaccination is projected to have a substantial public health impact by reducing RSV-related morbidity and mortality in the OA population.

Plain Language Summary

Respiratory syncytial virus (RSV) is one of the most frequent disease-causing agents that leads to common cold symptoms. In older adults, infection with RSV can result in severe complications including bronchitis/bronchiolitis, lung infection (pneumonia) and in rare cases death. Older people and people with chronic heart or lung disease are more likely to experience complications. We estimated that more than 5 million RSV cases occur in older adults (≥60 years) over a three-year period (1.8 million over one year). Many older adults (≥60 years) will see their treating physician because of an acute RSV infection or will be hospitalized.

Recently, a vaccine has been registered which protects older adults against RSV disease: the RSV prefusion F protein Older Adult (RSVPreF3 OA) vaccine. Vaccination with RSVPreF3 OA could prevent RSV infection in the older adult population and reduce the number of outpatient visits and hospitalizations; the impact is particularly high in Japan, where 35% of people are 60 years or older. We used a public health impact model to estimate how many RSV cases, hospitalizations and deaths could be prevented if 50% of people aged ≥ 60 years received the RSVPreF3 OA vaccine: We found that the vaccine could prevent about 1 million RSV infections, more than 728,000 outpatient visits, approximately 143,000 hospitalizations and 6,840 RSV-related deaths over a three-year period.

Adding RSVPreF3 OA vaccine to the national immunization program in Japan could protect older adults against RSV disease and reduce the burden on patients and the healthcare system.

KEYWORDS:

• Japan
• lower respiratory tract disease
• older adults
• public health impact
• respiratory syncytial virus (RSV)
• RSV prefusion F protein vaccine

Abbreviations

ARI	=	acute respiratory infection
DSA	=	deterministic sensitivity analysis
FDA	=	Food and Drug Administration
HCRU	=	healthcare resource use
LRTD	=	lower respiratory tract disease
NIP	=	national immunization program
NNV	=	number needed to vaccinate
RSV	=	respiratory syncytial virus
RSVPreF3 OA	=	RSV prefusion F protein-based vaccine for older adults
URTD	=	upper respiratory tract disease

Declaration of interest

A Mizukami, F Verelst, D Molnar and YF Ho are employed by GSK. F Verelst, D Molnar and Y Ho also hold shares in GSK. V Preckler was employed by and held shares in GSK during the study conduct. T Matsuki was employed and held shares by GSK during the study conduct and is currently employed by MSD. D Kurai received consulting fees from GSK in the context of this work. D Kurai also received consulting fees from GSK, Janssen Pharmaceutical K.K., Daiichi Sankyo Company, Limited and Asahi Kasei Pharma Corporation outside of this work and honoraria from GSK, Shionogi & Co., Ltd., Gilead Sciences, Janssen Pharmaceutical K.K., Taisho Pharmaceutical Co., Ltd., Kaken Pharmaceutical CO., LTD., AstraZeneca K.K., Kyorin Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd. and Alfresa Corporation outside of this work. D Kurai’s institution also received donation from Asahi Kasei Pharma Corporation, Maruishi Pharmaceutical. Co., Ltd., Shionogi & Co., Ltd. and Kyorin Pharmaceutical Co., Ltd. outside of this work and research funding from Daiichi Sankyo Company, Limited outside of this work. A Igarashi received payment from GSK for the conduct of this work and payments from Takeda Pharmaceuticals, Pfizer, Moderna and MSD, outside of this work. These authors declare no other financial and non-financial relationships and activities and no conflict of interest.

Reviewer disclosures

Peer reviewers on this manuscript have received honoraria for their review work. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.

Author contributions

All authors participated in the design or implementation or analysis, and interpretation of the study, and the development of this manuscript. All authors had full access to the results and gave final approval before submission.

Trademark

AS01 is a trademark owned by or licensed to GSK.

Previous presentations

JSVAC | 20–21 October 2023 |Shizuoka, Japan

Data availability statement

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Geolocation information

Japan.

Acknowledgments

The authors would like to thank Shoko Akiyama who provided support for the study. The authors would also like to thank Business & Decision Life Sciences Medical Communication Service Center for editorial assistance and manuscript coordination, on behalf of GSK. Katrin Spiegel provided medical writing support.

Additional information

Funding

This study was funded by GlaxoSmithKline Biologicals SA (GSK study identifier: VEO-000377). GlaxoSmithKline Biologicals SA was involved in all stages of study conduct, including analysis of the data. GlaxoSmithKline Biologicals SA also took charge of all costs associated with the development and publication of this manuscript.