儿童免疫接种后不良事件的基于SMS的积极监测:VigiVax研究
Laura Augusta Gonella1, Francesca Moretti2, Annalisa Capuano3
1Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy.
Vaccines
|September 28, 2024
概括
基于短消息服务 (SMS) 的监控有效地捕捉了儿童免疫接种后的不良事件 (AEFI). 这种数字化方法提高了报告准确性,并证实了儿科疫苗接种的安全性.
科学领域:
- 药物监督 药物监督 药物监督
- 数字卫生技术数字卫生技术
- 儿科公共卫生 儿科公共卫生
背景情况:
- 免疫接种后不良事件自发报告系统 (AEFI) 报告不足.
- 传统的监测方法可能无法捕获疫苗安全信号的全部频谱.
- 数字技术为改善AEFI检测提供了潜在的解决方案.
研究的目的:
- 评估基于短信服务 (SMS) 的监控对幼儿AEFI检测的有效性.
- 在报告的完整性和及时性方面,将基于SMS的监控与传统方法进行比较.
- 通过使用现实世界的数据,评估儿科疫苗的安全性.
主要方法:
- 一项使用VigiVax软件的队列事件监测研究.
- 年龄在2岁以下的儿童的家长收到了关于AEFI疫苗接种后 (2021年3月至2022年5月) 的短信询问.
- 短信回复得到了验证,并与电子免疫注册表集成,并提交给意大利药监系统.
主要成果:
- 在254,160条发送的短信中,实现了28.2%的响应率.
- 8.3%的回答报告了AEFI,其中0.24%被归类为严重.
- 31份报告 (RR:6.86/100,000剂量) 可能与疫苗有关,其中包括11例MMRV疫苗接种后发烧发作.
结论:
- 与传统系统相比,基于SMS的监控显著改善了AEFI报告.
- 数字技术的整合增强了药物监管能力.
- 儿童接种疫苗显示出有利的风险概况,加强了公众的信心.
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