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Clare L Cutland¹, Kimberley Gutu², Jessica Ann Yun¹

¹Wits African Leadership in Vaccinology Expertise (Wits-Alive), School of Pathology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.

|July 5, 2025

概括

尽管存在数据挑战,但在非洲国家建立积极的疫苗安全监测是可行的. 这对于监测低收入和中等收入国家 (LMICs) 的COVID-19疫苗安全性至关重要.

科学领域:

全球健康全球健康
疫苗学疫苗学疫苗学
公共卫生监督公共卫生监督

背景情况:

疫苗安全监测存在重大差距,特别是在低收入和中等收入国家 (LMICs),由于资源限制.
挑战包括纸质记录,缺乏独特的患者标识符,有限的电子数据捕获和临床审查员的短缺.
这份报告详细介绍了在九个非洲国家开展的两项活性疫苗安全监测研究.

研究的目的:

建立和评估非洲LMICs的活跃疫苗安全监测系统.
监测参与国家的COVID-19疫苗的安全性.
评估在资源有限的环境中识别特殊兴趣的不良事件 (AESI) 的可行性.

主要方法:

进行了两项基于医院的哨戒主动监测研究:主动COVID-19疫苗安全监测 (ACVaSS) 和南非COVID-19疫苗安全监测研究 (SA-CVSS).
具有预先选择的AESI症状的患者在知情同意的情况下被录取.
布莱顿协作案例定义被用来对AESI进行分类.

主要成果:

在18个月内,超过6万名患者进行了查,超过12,700名患者被录取.
尽管纸质记录存在挑战,但确定AESI并估计它们与疫苗接种状况的关联是可行的.
这些研究成功地在LMIC医疗保健机构建立了监测平台.

结论:

主动疫苗安全监测哨戒站点在LMICs中是可以实现的.
缺乏数字医疗记录显著阻碍了数据的可访问性和可用性.
优先考虑这些系统的开发,资金和维护对于确保疫苗在推出后的安全性至关重要.

关键词:

积极的疫苗安全监测活动.药物监督药物监督药物监督

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