Incidence of ischemic stroke after COVID-19 bivalent booster vaccination in an integrated health system

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-10-22 DOI:10.1016/j.vaccine.2024.126440

Katie A. Sharff , Thomas K. Tandy , Paul F. Lewis , Eric S. Johnson

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引用次数: 0

Abstract

We conducted a retrospective cohort study of Kaiser Permanente Northwest patients 18 years and older who were vaccinated with the COVID-19 bivalent vaccine between September 1, 2022 and March 1, 2023. We replicated the Vaccine Safety Datalink (VSD) rapid cycle analysis protocol to identify cases of ischemic stroke or transient ischemic attack (TIA) in the 21 days following vaccination using ICD-10-CM diagnosis codes in the primary position. The incidence of ischemic stroke or TIA was 34.3 per 100,000 (95 % CI, 17.7–59.9) in patients 65 years or older who received the bivalent Pfizer vaccine. Although a safety signal was detected in this study, further investigation is warranted to validate an association between COVID-19 vaccination and risk of ischemic stroke. Replication of the VSD case definition confirmed the exceptionally high positive predictive value in identifying ischemic stroke or TIA within 21 days of Pfizer bivalent vaccination in individuals 65 years and older. Two physician adjudication with chart review and confirmation of ischemic stroke cases allowed accurate absolute incidence estimates of stroke per 100,000 vaccine recipients and is helpful in calculation of net benefit for policy recommendations and shared decision-making.

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在一个综合医疗系统中接种 COVID-19 二价强化疫苗后缺血性中风的发病率。

我们对 2022 年 9 月 1 日至 2023 年 3 月 1 日期间接种 COVID-19 二价疫苗的 18 岁及以上西北凯撒医疗集团患者进行了一项回顾性队列研究。我们复制了疫苗安全数据链接 (VSD) 快速周期分析方案，使用 ICD-10-CM 诊断代码在主要位置识别接种疫苗后 21 天内的缺血性中风或短暂性脑缺血发作 (TIA) 病例。在接种二价辉瑞疫苗的 65 岁及以上患者中，缺血性中风或 TIA 的发病率为每 10 万人中有 34.3 例（95 % CI，17.7-59.9）。虽然本研究发现了一个安全信号，但仍需进一步调查以验证接种 COVID-19 疫苗与缺血性中风风险之间的关联。对 VSD 病例定义的复制证实了在 65 岁及以上人群中接种辉瑞二价疫苗后 21 天内发现缺血性中风或 TIA 的阳性预测值非常高。两名医生通过病历审查和缺血性中风病例确认进行判定，可准确估算出每 10 万名疫苗接种者中风的绝对发病率，有助于计算净获益以提出政策建议和共同决策。

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

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.