新冠肺炎疫苗安全监测中接种疫苗后特定不良事件的预期发生率。

Expected Rates of Select Adverse Events After Immunization for Coronavirus Disease 2019 Vaccine Safety Monitoring.

机构信息

CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GeorgiaUSA.

出版信息

J Infect Dis. 2022 May 4;225(9):1569-1574. doi: 10.1093/infdis/jiab628.

Abstract

Using meta-analytic methods, we calculated expected rates of 20 potential adverse events of special interest (AESI) that would occur after coronavirus disease 2019 (COVID-19) vaccination within 1-, 7-, and 42-day intervals without causal associations. Based on these expected rates, if 10 000 000 persons are vaccinated, (1) 0.5, 3.7, and 22.5 Guillain-Barre syndrome cases, (2) 0.3, 2.4, and 14.3 myopericarditis cases, (3) and 236.5, 1655.5, and 9932.8 all-cause deaths would occur coincidentally within 1, 7, and 42 days postvaccination, respectively. Expected rates of potential AESI can contextualize events associated temporally with immunization, aid in safety signal detection, guide COVID-19 vaccine health communications, and inform COVID-19 vaccine benefit-risk assessments.

摘要

我们使用荟萃分析方法计算了新冠肺炎(COVID-19)疫苗接种后 1、7 和 42 天内无因果关联的 20 种特殊关注不良事件(AESI)的预期发生率。基于这些预期发生率,如果有 1000 万人接种疫苗,(1)分别会有 0.5、3.7 和 22.5 例格林-巴利综合征病例,(2)分别会有 0.3、2.4 和 14.3 例心肌炎病例,(3)分别会有 236.5、1655.5 和 9932.8 例全因死亡病例在接种后 1、7 和 42 天内巧合发生。潜在 AESI 的预期发生率可以使与免疫接种相关的事件具有背景意义,有助于安全信号检测,指导 COVID-19 疫苗健康传播,并为 COVID-19 疫苗的获益-风险评估提供信息。

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