Abstract：
BACKGROUND: A new monoclonal antibody (nirsevimab; Beyfortus®) and a bivalent prefusion RSV vaccine (Abrysvo®) for maternal immunization have been approved recently. This is a modelling study to estimate the potential impact of different immunization programs with these products on RSV-bronchiolitis.
METHODS: Population-based real-world data from primary care and hospitalizations were considered. RSV bronchiolitis dynamics in absence of these immunization scenarios were explained by a multivariate age-structured Bayesian model. Then, the potential impact was simulated under different assumptions including the most recent clinical trial data. Differences in endpoints, populations, and timeframes between trials make the two products\' efficacy difficult to compare.
RESULTS: A seasonal with catch-up program, assuming a constant effectiveness of 79.5 % during the first 5 months followed by a linear decay to 0 by month 10 with nirsevimab, would prevent between 5121 and 8846 RSV bronchiolitis per 100,000 infants-years. Assuming 77.3 % effectiveness with the same decay, between 976 and 1686 RSV-hospitalizations per 100,000 infants-years could be prevented depending on the uptake. A year-round maternal immunization program, with 51 % of effectiveness during the first 6 months followed by a linear decay to 0 by month 10 would prevent between 3246 and 5606 RSV bronchiolitis cases per 100,000 infants-years. Assuming 56.9 % effectiveness with the same decay, between 713 and 1231 RSV-hospitalizations per 100,000 infants-years could be prevented.
CONCLUSIONS: Our results suggest that each strategy would effectively reduce RSV-bronchiolitis.
METHODS: Population-based real-world data from primary care and hospitalizations were considered. RSV bronchiolitis dynamics in absence of these immunization scenarios were explained by a multivariate age-structured Bayesian model. Then, the potential impact was simulated under different assumptions including the most recent clinical trial data. Differences in endpoints, populations, and timeframes between trials make the two products\' efficacy difficult to compare.
RESULTS: A seasonal with catch-up program, assuming a constant effectiveness of 79.5 % during the first 5 months followed by a linear decay to 0 by month 10 with nirsevimab, would prevent between 5121 and 8846 RSV bronchiolitis per 100,000 infants-years. Assuming 77.3 % effectiveness with the same decay, between 976 and 1686 RSV-hospitalizations per 100,000 infants-years could be prevented depending on the uptake. A year-round maternal immunization program, with 51 % of effectiveness during the first 6 months followed by a linear decay to 0 by month 10 would prevent between 3246 and 5606 RSV bronchiolitis cases per 100,000 infants-years. Assuming 56.9 % effectiveness with the same decay, between 713 and 1231 RSV-hospitalizations per 100,000 infants-years could be prevented.
CONCLUSIONS: Our results suggest that each strategy would effectively reduce RSV-bronchiolitis.
摘要：
背景：最近批准了一种用于母体免疫的新型单克隆抗体（nirsevimab;Beyfortus®）和二价融合前RSV疫苗（Abrysvo®）。这是一项建模研究，旨在评估使用这些产品的不同免疫程序对RSV-细支气管炎的潜在影响。
方法：考虑了来自初级保健和住院的基于人群的真实数据。在没有这些免疫方案的情况下，RSV细支气管炎动力学由多变量年龄结构贝叶斯模型解释。然后，我们在不同假设下模拟了潜在影响,包括最新的临床试验数据.端点的差异，人口,和试验之间的时间框架使两种产品的功效难以比较。
结果：季节性追赶计划，假设在前5个月中恒定的有效性为79.5%，然后在使用nirsevimab的第10个月时线性衰减为0，将预防每100,000名婴儿5121至8,846RSV毛细支气管炎。假设具有相同衰减的77.3%的有效性，每100,000名婴儿中976至16,86RSV住院治疗可以根据摄取情况进行预防.全年的孕产妇免疫计划，在前6个月期间有51%的有效性,然后在第10个月时线性衰减至0,将可预防每100,000个婴儿中的3,246至5,606例RSV毛细支气管炎病例.假设56.9%的有效性具有相同的衰减，可以预防每100,000名婴儿713至1231例RSV住院治疗.
结论：我们的结果表明，每种策略都可以有效减少RSV-细支气管炎。
方法：考虑了来自初级保健和住院的基于人群的真实数据。在没有这些免疫方案的情况下，RSV细支气管炎动力学由多变量年龄结构贝叶斯模型解释。然后，我们在不同假设下模拟了潜在影响,包括最新的临床试验数据.端点的差异，人口,和试验之间的时间框架使两种产品的功效难以比较。
结果：季节性追赶计划，假设在前5个月中恒定的有效性为79.5%，然后在使用nirsevimab的第10个月时线性衰减为0，将预防每100,000名婴儿5121至8,846RSV毛细支气管炎。假设具有相同衰减的77.3%的有效性，每100,000名婴儿中976至16,86RSV住院治疗可以根据摄取情况进行预防.全年的孕产妇免疫计划，在前6个月期间有51%的有效性,然后在第10个月时线性衰减至0,将可预防每100,000个婴儿中的3,246至5,606例RSV毛细支气管炎病例.假设56.9%的有效性具有相同的衰减，可以预防每100,000名婴儿713至1231例RSV住院治疗.
结论：我们的结果表明，每种策略都可以有效减少RSV-细支气管炎。
