A three-part model for the self-controlled case series design to estimate and characterize adverse event risk in an overlapping risk period after multiple vaccines: application to ischemic stroke following Pfizer-BioNTech bivalent COVID-19 vaccine and influenza vaccine.

IF 5 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Stanley Xu, Lina S Sy, Xuan Huang, Vennis Hong, Bing Han, Katia J Bruxvoort, Bruno Lewin, Kimberly J Holmquist, Lei Qian
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引用次数: 0

Abstract

This study proposes a three-part model to assess and characterize the risk of serious adverse events (SAEs) when two vaccines are administered on the same day or in close proximity within a self-controlled case series framework. Simulations showed that the three-part model yielded unbiased relative incidences (RIs) after each vaccination and during the overlapping risk period, while censoring follow-up at dose 2 reduced estimation precision but produced unbiased point estimates. Assuming positive multiplicative and positive additive effects, including the overlapping risk period in the first risk interval overestimated the RI after the first dose by 6.0%-26.0%, while including it in the second overestimated the second RI by 7.3%-34.0%. Overall analysis using the three-part model found no increased ischemic stroke risk 42 days after Pfizer-BioNTech bivalent COVID-19 vaccination or after influenza vaccination or during the overlapping risk period among Kaiser Permanente Southern California members <65 years. Among those with a prior-year history of SARS-CoV-2 infection, the overlapping period showed a significantly increased risk (RI=2.74 [95% confidence intervals, 1.07-7.07]), indicating both positive multiplicative and additive effects. Further research is needed to validate these ischemic stroke findings with chart review confirmation and to apply the model to other vaccination scenarios.

一种自我控制病例系列设计的三部分模型,用于评估和表征多种疫苗接种后重叠风险期的不良事件风险:辉瑞- biontech二价COVID-19疫苗和流感疫苗在缺血性卒中中的应用。
本研究提出了一个由三部分组成的模型,以评估和描述在同一天或在自我控制的病例系列框架内近距离接种两种疫苗时发生严重不良事件(sae)的风险。模拟表明,该三部分模型在每次接种疫苗后和重叠风险期产生无偏的相对发病率(RIs),而在剂量2时审查随访降低了估计精度,但产生了无偏的点估计。假设正乘法和正加性效应,包括第一个风险区间的重叠风险期,高估了第一次剂量后的RI 6.0%-26.0%,而将其纳入第二个风险区间,则高估了第二次RI 7.3%-34.0%。使用三部分模型的总体分析发现,在Kaiser Permanente南加州会员中,接种辉瑞- biontech二价COVID-19疫苗后42天或流感疫苗后或重叠风险期,缺血性卒中风险没有增加
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
American journal of epidemiology
American journal of epidemiology 医学-公共卫生、环境卫生与职业卫生
CiteScore
7.40
自引率
4.00%
发文量
221
审稿时长
3-6 weeks
期刊介绍: The American Journal of Epidemiology is the oldest and one of the premier epidemiologic journals devoted to the publication of empirical research findings, opinion pieces, and methodological developments in the field of epidemiologic research. It is a peer-reviewed journal aimed at both fellow epidemiologists and those who use epidemiologic data, including public health workers and clinicians.
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