Department of Health Management and Policy, School of Public Health.
Susan B. Meister Child Health Evaluation and Research Center (CHEAR), University of Michigan, Ann Arbor, Michigan.
Pediatrics. 2024 Dec 1;154(6). doi: 10.1542/peds.2024-066481.
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.
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.
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.
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.
呼吸道合胞病毒（RSV）常导致美国婴儿住院。一种预防婴儿 RSV 的母体疫苗，即 RSV 二价融合前 F 母体疫苗（RSVpreF），已获得美国食品和药物管理局的批准，并被免疫实践咨询委员会推荐。我们的目标是评估在美国孕妇中使用 RSVpreF 进行疫苗接种的健康效益和成本效益。
我们在妊娠第 32 周到第 36 周期间，对每年美国出生队列中一半的孕妇进行了 RSV 感染和疾病的模拟，同时进行了季节性 RSVpreF 疫苗接种和不进行季节性 RSVpreF 疫苗接种。模型输入来自同行评议文献、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，从社会角度报告了为期 1 年的情况，对未来的健康结果和成本按 3%进行贴现。进行了敏感性和情景分析。
每年对孕妇进行 RSVpreF 疫苗接种将预防每年 45693 次门诊就诊、15866 次急诊就诊和 7571 次住院治疗。疫苗接种的社会增量成本为每获得 1 个质量调整生命年（QALY）节省 396280 美元。从 9 月到 1 月的疫苗接种每节省 1 个 QALY 的成本为 163513 美元。最具影响力的输入是 RSV 疾病导致的 QALYs 丧失、疫苗成本和 RSV 相关住院费用；这些输入的变化产生的结果从节省成本到每 QALY 节省 80 万美元不等。
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，特别是如果在 RSV 季节之前或开始时立即为孕妇接种疫苗。
