接种COVID-19疫苗后的血栓栓塞事件:一项意大利回顾性真实世界的安全研究
Francesca Futura Bernardi1, Annamaria Mascolo2,3, Marina Sarno4
1Directorate-General for Health Protection, Campania Region, 80143 Naples, Italy.
Vaccines
|October 28, 2023
概括
现实世界的数据显示,病毒载体COVID-19疫苗,特别是牛津-阿斯特拉泽内卡的病毒载体COVID-19疫苗的血栓栓塞事件报告较高. 这项研究将牛津-阿斯特拉泽内卡疫苗的风险与其他COVID-19疫苗进行了比较,发现血栓栓塞病例中暴露的可能性增加.
科学领域:
- 药物监督 药物监督 药物监督
- 疫苗安全问题 疫苗安全问题
- 流行病学 流行病学
背景情况:
- 现实世界的安全性研究对于评估COVID-19疫苗接种后的血栓栓塞风险至关重要.
- 数以百万计的人已经接种了COVID-19疫苗,需要持续的安全监测.
- 对比不同类型的疫苗,比如牛津-阿斯特拉泽内卡与其他疫苗,对公共卫生至关重要.
研究的目的:
- 为了估计COVID-19疫苗接种后血栓栓塞事件的发生率.
- 为了比较牛津-阿斯特拉泽内卡疫苗与其他COVID-19疫苗在血栓栓塞事件方面的安全性.
- 分析与这些事件相关的特定疫苗暴露报告率和概率.
主要方法:
- 使用意大利药监局 (RNF) 和坎帕尼亚地区卫生 (SINFONIA) 数据库进行的回顾性现实安全研究.
- 从2021年12月27日到2022年9月27日提取的数据,涵盖COVID-19疫苗接种和血栓塞栓事件.
- 每10,000剂量计算的报告率 (RR) 和比较牛津-阿斯特拉泽内卡与其他疫苗的几率比率 (OR).
主要成果:
- 接种了超过1260万剂疫苗; 瑞-生物科技是最常见的 (65.05%).
- 牛津-阿斯特拉泽内卡 (4.62) 和詹森 (3.45) 疫苗观察到较高的血栓栓塞事件报告率 (RR).
- 与Pfizer-BioNTech (OR:6.06) 和Moderna (OR:6.46) 相比,血栓栓塞的病例显示了之前牛津-阿斯特拉塞内卡暴露的几率显著更高.
结论:
- 病毒载体疫苗 (Oxford-AstraZeneca,Janssen) 与更高的血栓栓塞事件报告有关.
- 与mRNA疫苗 (Pfizer-BioNTech,Moderna) 相比,在经历血栓栓塞事件的人群中,注意到牛津-阿斯特拉泽内卡暴露的可能性增加.
- 调查结果强调了在现实环境中对疫苗特定安全性监测的重要性.
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