接种MPox () 疫苗后的不良反应:来自荷兰和全球不良事件报告系统的概述
Meiwen van der Boom1, Florence van Hunsel1
1Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
British journal of clinical pharmacology
|June 21, 2023
概括
在荷兰接种疫苗后的不良事件大多是轻微的注射部位反应. 安全概况与产品信息一致,这表明在实践中安全概况有利.
科学领域:
- 免疫学 免疫学 免疫学
- 公共卫生 公共卫生
- 药物监督 药物监督 药物监督
背景情况:
- 由于MPox病毒的全球传播,荷兰需要针对高风险人群开展疫苗接种活动.
- 了解MPox疫苗的安全概况对于公共卫生战略和疫苗信心至关重要.
研究的目的:
- 描述荷兰对疫疫苗接种报告的免疫接种后不良事件 (AEFI).
- 根据自发的AEFI报告,评估疫苗的真实安全概况.
主要方法:
- 数据来自荷兰药监中心Lareb自发报告系统.
- 根据世界卫生组织数据库,在2022年接种小天花或天花疫苗后的全球AEFI数据被审查.
主要成果:
- 在荷兰,截至2022年11月15日,已收到148份个案安全报告 (ICSR),其中1.4%报告严重结果.
- 在全球范围内,2022年报告了2205例ICSR,其中5.9%表明严重反应.
- 在两个数据库中常见的AEFI包括注射部位反应和一般系统反应.
结论:
- 荷兰和全球数据库中的疫苗AEFI模式与制造商的产品信息保持一致.
- 报告的不良事件主要是注射部位的非严重反应和全身反应性.
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