Department of Internal Medicine B, Lady Davis Carmel Medical Center, Haifa, Israel.
Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Eur J Neurol. 2023 Dec;30(12):3868-3876. doi: 10.1111/ene.16025. Epub 2023 Aug 13.
Existing data regarding the link between COVID-19 vaccine and myasthenia gravis (MG) are scarce. We aimed to assess the association between Pfizer-BioNTech vaccine with both new-onset MG and MG exacerbation.
For the first aim, we conducted a nested case-control study in a cohort of 3,052,467 adults, without a diagnosis of MG, from the largest healthcare provider in Israel. Subjects were followed from January 1, 2021 until June 30, 2022 for the occurrence of MG. Ten randomly selected controls were matched to each case of new-onset MG on age and sex. For the second aim, a nested case-control study was conducted in a cohort of 1446 MG patients. Four randomly selected MG patients (controls) were matched to each case of MG exacerbation. Exposure to COVID-19 vaccine in the prior 4 weeks was assessed in cases and controls.
Overall, 332 patients had new-onset MG and were matched with 3320 controls. Multivariable conditional logistic regression models showed that the odds ratio (OR) for new-onset MG, associated with COVID-19 vaccine, was 1.14 (95% CI 0.73-1.78). The results were consistent in sensitivity analysis that used more stringent criteria to define MG. Overall, 62 patients with MG exacerbation were matched to 248 MG controls. The multivariable OR for MG exacerbation, associated with COVID-19 vaccine, was 1.35 (95% CI 0.37-4.89). All results were similar when the prior exposure to COVID-19 vaccine was extended to 8 weeks.
This study suggests that Pfizer-BioNTech vaccine is not associated with increased risk of new-onset nor exacerbation of MG.
关于 COVID-19 疫苗与重症肌无力(MG)之间联系的现有数据较少。我们旨在评估辉瑞-生物科技疫苗与新发 MG 和 MG 恶化之间的关联。
为了实现第一个目标,我们在以色列最大的医疗保健提供者的 3052467 名成年人队列中进行了一项嵌套病例对照研究,这些成年人没有 MG 诊断。从 2021 年 1 月 1 日到 2022 年 6 月 30 日,对 MG 的发生进行了随访。对于新发 MG,每例病例均与年龄和性别相匹配的 10 名随机选择的对照相匹配。对于第二个目标,在 1446 名 MG 患者队列中进行了一项嵌套病例对照研究。每例 MG 恶化病例均与 4 名随机选择的 MG 患者(对照)相匹配。评估了病例和对照者在 4 周内 COVID-19 疫苗的暴露情况。
共有 332 名患者出现新发 MG,并与 3320 名对照相匹配。多变量条件逻辑回归模型显示,与 COVID-19 疫苗相关的新发 MG 的优势比(OR)为 1.14(95% CI 0.73-1.78)。在使用更严格的标准定义 MG 的敏感性分析中,结果是一致的。共有 62 名 MG 恶化患者与 248 名 MG 对照相匹配。与 COVID-19 疫苗相关的 MG 恶化的多变量 OR 为 1.35(95% CI 0.37-4.89)。当 COVID-19 疫苗的既往暴露时间延长至 8 周时,所有结果均相似。
本研究表明,辉瑞-生物科技疫苗与新发 MG 或 MG 恶化的风险增加无关。