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Cost-Effectiveness Analysis of the mRNA-1345 RSV Vaccine for Adults in the United States: Clinical and Economic Value

Hicks, K.; Xiao, Z.; Fust, K.; Kohli, M.; Paret, K.; Zhang, W.; del Pilar Martin Matos, M.; Joshi, K.; Ghaswalla, P.

2025-08-05 infectious diseases
10.1101/2025.08.01.25332812 medRxiv
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BackgroundThe clinical and economic burden of respiratory syncytial virus (RSV) is significant; millions of patients seek medical care due to RSV infections each year. Recently approved vaccines offer an important opportunity to reduce this burden in populations that are at high risk due to certain medical conditions or older age. This study evaluates the public health impact and cost-effectiveness of vaccination with mRNA-1345 against RSV in adults. MethodsA static decision-analytic model was developed to estimate the public health impact and cost-effectiveness of vaccinating high-risk adults aged 18-59 years and all adults aged [≥] 60 years in the 5-year period following vaccination against RSV with a single dose of mRNA-1345 in the United States (US). RSV vaccination rates in the analysis were assumed to be equal to 2019-2020 influenza season vaccination rates. Vaccine effectiveness against RSV-related acute respiratory disease and RSV-associated lower respiratory tract infection over time was modeled using nonlinear waning curves that reflect clinical trial data. ResultsAccording to the model, vaccinating the high-risk adult US population aged 18-59 years and all US adults aged [≥] 60 years with mRNA-1345 would avert over 280,000 hospitalizations, 19,000 deaths, and result in about 244,000 quality-adjusted life-years gained compared with an unvaccinated population over a 5-year period. Vaccination costs approximately $23.2 billion and reduces direct and indirect costs by $10.8 billion and $13.3 billion, respectively, resulting in net savings of more than $810 million from a societal perspective, making vaccination with mRNA-1345 in this population cost saving. ConclusionsVaccination with mRNA-1345 is a cost-saving strategy for the prevention of RSV in high-risk and older US adults and has the potential for substantial public health impact. KEY SUMMARY POINTSO_ST_ABSWhy carry out this study? (1-2 bullets)C_ST_ABSO_LIThe clinical and economic burden of respiratory syncytial virus (RSV) in high-risk and older adults is significant C_LIO_LIThe mRNA-1345 RSV vaccine has been approved in adults aged [≥] 60 years in 2024 and high-risk adults 18-59 years old in 2025, but the potential clinical benefit and cost-effectiveness of RSV vaccination has not been established. C_LI What did the study ask?/What was the hypothesis of the study? (1 bullet)O_LIThe study objective was to examine the public health impact and cost-effectiveness of RSV vaccination with mRNA-1345 compared with no vaccination in high-risk adults aged 18-59 years and all adults aged [≥] 60 years in the United States (US) in the 5-year period following vaccination. C_LI What were the study outcomes/conclusions? (1 bullet point)O_LIVaccination with mRNA-1345 results in 280,000 fewer hospitalizations, over 19,000 fewer deaths, and over $810 million in economic savings from a societal perspective compared with not vaccinating against RSV over a 5-year period. C_LI What has been learned from the study? (1-2 bullets)O_LIThese analyses suggest the mRNA-1345 vaccine is a cost-saving strategy for the prevention of RSV in US adults across age groups and has the potential for substantial public health impact. C_LIO_LIOur findings may inform clinical and policy decision-making regarding the value of RSV vaccination in adults and support efforts to expand access among younger high-risk populations. C_LI PLAIN LANGUAGE SUMMARYRespiratory syncytial virus (RSV) is a common virus that causes lung infections. It can be especially dangerous for older adults and people with health conditions like asthma, heart disease, or diabetes. Each year, RSV causes many hospital stays and even deaths in the United States. A new vaccine called mRNA-1345 was recently approved to protect adults aged 60 and older, and high-risk adults aged 18-59. This study looked at whether giving the vaccine to these groups would help prevent RSV infections and save money. Researchers used a mathematical model to compare what might happen over 5 years with and without the vaccine. They found that the vaccine could prevent over 280,000 hospital stays and more than 19,000 deaths. Even though the vaccine costs money, it would save more than $800 million by reducing medical bills and helping people stay healthy and working. RSV can place a heavy burden on individuals and the healthcare system. This study shows that the mRNA-1345 vaccine could protect the most vulnerable adults while also being a valuable investment for society.

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