BACKGROUND AND OBJECTIVES Respiratory syncytial virus (RSV) commonly causes hospitalization among US infants. A maternal vaccine preventing RSV in infants, RSV bivalent prefusion F maternal vaccine (RSVpreF), was approved by the US Food and Drug Administration and recommended by the Advisory Committee on Immunization Practices. Our objective was to evaluate the health benefits and cost-effectiveness of vaccinating pregnant persons in the United States using RSVpreF. METHODS We simulated RSV infection and disease with and without seasonal RSVpreF vaccination in half of the pregnant persons in the annual US birth cohort during weeks 32 through 36 of gestation. Model inputs came from peer-reviewed literature, Food and Drug Administration records, and epidemiological surveillance databases. The results are reported using a societal perspective in 2022 US dollars for a 1-year time frame, discounting future health outcomes and costs at 3%. Sensitivity and scenario analyses were performed. RESULTS Year-round maternal vaccination with RSVpreF would prevent 45 693 outpatient visits, 15 866 ED visits, and 7571 hospitalizations among infants each year. Vaccination had a societal incremental cost of $396 280 per quality-adjusted life-year (QALY) saved. Vaccination from September through January cost $163 513 per QALY saved. The most influential inputs were QALYs lost from RSV disease, the cost of the vaccine, and RSV-associated hospitalization costs; changes in these inputs yielded outcomes ranging from cost-saving to $800 000 per QALY saved. CONCLUSIONS Seasonal maternal RSV vaccination designed to prevent RSV lower respiratory tract infection in infants may be cost-effective, particularly if administered to pregnant persons immediately before or at the beginning of the RSV season.

中文翻译：

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孕产妇疫苗接种预防呼吸道合胞病毒病的成本效益。


背景和目标 呼吸道合胞病毒 （RSV） 通常会导致美国婴儿住院。一种预防婴儿 RSV 的母系疫苗，即 RSV 二价前融合 F 母体疫苗 （RSVpreF），已获得美国食品和药物管理局的批准，并得到免疫实践咨询委员会的推荐。我们的目的是评估使用 RSVpreF 为美国孕妇接种疫苗的健康益处和成本效益。方法 我们模拟了美国年度出生队列中一半孕妇在妊娠 32 至 36 周期间接种季节性 RSVpreF 疫苗的 RSV 感染和疾病。模型输入来自同行评审文献、食品和药物管理局记录以及流行病学监测数据库。结果以 2022 年美元为单位，以 1 年时间框架报告，将未来的健康结果和成本贴现 3%。进行了敏感性和情景分析。结果 全年孕产妇接种 RSVpreF 疫苗每年可预防婴儿门诊就诊 45 693 次、急诊就诊 15 866 次和住院 7571 次。疫苗接种每节省一个质量调整生命年 （QALY） 就会产生 396 280 美元的社会增量成本。从 9 月到 1 月的疫苗接种费用为每节省 QALY 163 513 美元。最有影响力的输入是 RSV 疾病造成的 QALYs 损失、疫苗费用和 RSV 相关住院费用;这些投入的变化产生的结果从节省成本到每节省 QALY 800 000 美元不等。结论 旨在预防婴儿 RSV 下呼吸道感染的季节性母体 RSV 疫苗接种可能具有成本效益，尤其是在 RSV 季节之前或开始时对孕妇进行接种时。