接种COVID-19疫苗后的死亡风险:一个自我控制的病例系列研究研究
Stanley Xu1, Lina S Sy2, Vennis Hong2
1Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States; Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA, United States.
Vaccine
|February 22, 2024
概括
接种COVID-19疫苗并没有显示出因任何原因或心脏事件导致死亡的风险增加. 这项研究分析了美国初级COVID-19疫苗系列后的死亡率,没有发现任何重大安全问题.
科学领域:
- 流行病学 流行病学
- 疫苗安全研究 疫苗安全研究
- 公共卫生 公共卫生
背景情况:
- 之前关于COVID-19疫苗接种和死亡风险的研究有潜在的残留混.
- 修改自控案例系列 (SCCS) 设计用于减轻偏差.
- 该研究重点关注非COVID-19死亡率,全因死亡率和特定的心脏相关死亡结果.
研究的目的:
- 在初级COVID-19疫苗接种后评估非COVID-19死亡风险.
- 评估COVID-19疫苗接种后所有原因死亡的风险.
- 为了检查COVID-19疫苗接种后四种心脏相关死亡结果的风险.
主要方法:
- 利用修改后的SCCS设计分析了2020年12月至2021年8月的8个疫苗安全数据链站点的死亡.
- 在初级COVID-19疫苗系列 (Pfizer-BioNTech,Moderna,Janssen) 后,针对各种死亡结果计算出相对发病率 (RI).
- 经过季节性调整,使用日历月份,并将未接种疫苗的个人纳入分析,具有初级 (28天) 和二级 (14天) 风险间隔.
主要成果:
- 对于Pfizer-BioNTech和Moderna疫苗,所有原因和非COVID-19死亡率的相对发病率低于1,置信区间不包括1.
- 对于Moderna,两个与心脏相关的死亡率估计具有置信区间,包括1 (RI=0.78-0.80) 在特定子组的第二剂后14天.
- 对于詹森疫苗,心脏相关死亡的相对发病率在0.68-0.98之间,置信区间包括1.
结论:
- 经过修改的SCCS设计,考虑到时间趋势,在初级COVID-19疫苗接种后没有发现非COVID-19死亡率或所有原因死亡率的风险增加.
- 在接受美国三种主要COVID-19疫苗的人群中,没有发现四种特定的心脏相关死亡结果的风险增加.
- 这些发现支持关于死亡风险的初级COVID-19疫苗系列的安全性.
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