Real-world effectiveness and safety of nirsevimab, RSV maternal vaccine and RSV vaccines for older adults: a living systematic review and meta-analysis.

While clinical trials showed good efficacy and safety, their restrictive inclusion criteria, small sample sizes and short follow-up limit generalisability.

虽然临床试验显示了良好的有效性和安全性，但其限制性的纳入标准、小样本量和短暂的随访限制了其普遍适用性。

We aimed to summarise real-world evidence on the effectiveness and safety of nirsevimab, RSV maternal vaccine and RSV vaccines for older adults.

我们旨在总结关于nirsevimab、RSV母亲疫苗和针对老年人的RSV疫苗在真实世界中的有效性和安全性的证据。

Methods

A living systematic reviewand meta-analysis, with 5 monthly updated searches in three databases was performed.

我们进行了一项活系统综述和荟萃分析，每月更新一次搜索，共在三个数据库中进行了五次更新搜索。

Eligible studies were published from 1 December 2022 to 10 March 2025.

符合资格的研究发表日期从2022年12月1日至2025年3月10日。

Meta-analyses for the effectiveness of nirsevimab and RSV vaccines were carried out using random-effects model.

使用随机效应模型对nirsevimab和呼吸道合胞病毒疫苗的有效性进行了荟萃分析。

Safety data were summarised narratively.

安全性数据以叙述性方式总结。

Results

A total of 50 publications, covering approximately 7.6 million people, were included.

共纳入了50篇文献，涵盖了大约760万人。

Nirsevimab showed 80.7% effectiveness (95% CI: 75.7% to 85.7%; seven studies) against RSV-related emergency department visits, 80.7% (95% CI: 76.1% to 85.2%; 17 studies) against hospital admissions and 75.6% (95% CI: 63.3% to 87.9%; eight studies) against intensive care unit admissions.

Nirsevimab对RSV相关急诊就诊的有效性为80.7%（95%置信区间：75.7%至85.7%；七项研究），对住院的有效性为80.7%（95%置信区间：76.1%至85.2%；17项研究），对重症监护病房（ICU）住院的有效性为75.6%（95%置信区间：63.3%至87.9%；八项研究）。

The effectiveness of RSV vaccines for older adults against RSV-related hospital admissions was 79.6% (95% CI: 73.8% to 85.3; three studies).

针对RSV相关住院，老年人使用的RSV疫苗的有效性为79.6%（95%置信区间：73.8%至85.3%；三项研究）。

No effectiveness data were available for RSV maternal vaccine.

目前尚无RSV母体疫苗的有效性数据。

No severe adverse events were reported for nirsevimab, while RSV vaccines in older adults had fewer than 10 Guillain-Barré syndrome cases per million doses.

目前尚未报告nirsevimab的严重不良事件，而老年RSV疫苗每百万剂中出现的吉兰-巴雷综合征病例少于10例。

No severe adverse events were reported for RSV maternal vaccine, although evidence was limited.

尽管证据有限，但未报告RSV母体疫苗的严重不良事件。

Conclusions

Our review demonstrated high effectiveness of nirsevimab in reducing RSV-related healthcare utilisation in infants and a favourable safety profile.

我们的综述显示，nirsevimab在减少婴儿RSV相关医疗利用方面具有很高的有效性，并且具有良好的安全性。

More evidence is needed for evaluating RSV vaccines in pregnant people and older adults.

需要更多证据来评估孕妇和老年人接种呼吸道合胞病毒疫苗的效果。

prospero_registration_number

CRD42025643585.

CRD42025643585。