本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.1059

摘要内容如下：

重要性

2023年1月，美国疾病控制和预防中心和美国食品和药物管理局指出，在接受辉瑞生物技术BNT162B2的65岁或以上的成年人中，缺血性中风的安全性值得关注。WT/OMI BA.4/BA.5 Covid-19二价疫苗。

目的

评估接种（1）任一品牌的Covid-19二价疫苗，（2）任一品牌的Covid-19二价疫苗加高剂量或佐剂流感疫苗（同时接种），以及（3）高剂量或佐剂流感疫苗后的卒中风险。

设计、设置和参与者

自我对照病例系列包括11001名65岁或以上的医疗保险受益人，他们在接种任一品牌的Covid-19二价疫苗后发生中风（在5397278名接种疫苗的个体中）。研究期间为2022年8月31日至2023年2月4日。

曝光

接受（1）任一品牌的Covid-19二价疫苗（一级）或（2）高剂量或佐剂流感疫苗（二级）。

主要成果和措施

接种疫苗后1至21天或22至42天风险窗与43至90天控制窗期间的卒中风险（非出血性卒中、短暂性脑缺血发作、非出血性卒中或短暂性脑缺血发作或出血性卒中的联合结局）。

结果

有5397278名医疗保险受益人接种了任一品牌的新冠肺炎二价疫苗（中位年龄74岁[IQR，70-80岁]；56%为妇女）。在接种任一品牌的Covid-19二价疫苗后发生卒中的11001名受益人中，在1至21天或22至42天的风险窗口期与43至90天的对照窗口期，任一品牌的Covid-19二价疫苗与非出血性卒中、短暂性脑缺血发作、非出血性卒中或短暂性脑缺血发作或出血性卒中的结局之间均无统计学显著关联（发病率比[IRR]范围为0.72-1.12）。在同时接种任一品牌的Covid-19二价疫苗和高剂量或佐剂流感疫苗后发生中风的4596名受益人中，在Pfizer-Biontech BNT162B2的22至42天风险窗口期内，疫苗接种与非出血性中风之间存在统计学上显著的关联；WT/OMI BA.4/BA.5 Covid-19二价疫苗（IRR，1.20[95%CI，1.01-1.42]；风险差异/100，000剂，3.13[95%CI，0.05-6.22]），以及接种Moderna mRNA-1273.222 Covid-19二价疫苗后1-21天风险窗口期内，疫苗接种与短暂性脑缺血发作之间的统计学显著相关性（IRR，1.35[95%CI，1.06-1.74]；风险差异/10万剂量，3.33[95%CI，0.46-6.20]）。在接种高剂量或含佐剂流感疫苗后发生卒中的21345名受益人中，在22至42天的风险窗期间，疫苗接种与非出血性卒中之间存在统计学上显著的关联（IRR，1.09[95%CI，1.02-1.17]；风险差异/10万剂，1.65[95%CI，0.43-2.87]）。

结论和相关性

在65岁或以上的医疗保险受益人中，在接种任何一种品牌的Covid-19二价疫苗后发生中风，没有证据表明在接种疫苗后的几天内中风的风险显著增加。

英文原文如下：

Abstracts

Importance  In January 2023, the US Centers for Disease Control and Prevention and the US Food and Drug Administration noted a safety concern for ischemic stroke among adults aged 65 years or older who received the Pfizer-BioNTech BNT162b2; WT/OMI BA.4/BA.5 COVID-19 bivalent vaccine.

Objective  To evaluate stroke risk after administration of (1) either brand of the COVID-19 bivalent vaccine, (2) either brand of the COVID-19 bivalent plus a high-dose or adjuvanted influenza vaccine on the same day (concomitant administration), and (3) a high-dose or adjuvanted influenza vaccine.

Design, Setting, and Participants  Self-controlled case series including 11 001 Medicare beneficiaries aged 65 years or older who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine (among 5 397 278 vaccinated individuals). The study period was August 31, 2022, through February 4, 2023.

Exposures  Receipt of (1) either brand of the COVID-19 bivalent vaccine (primary) or (2) a high-dose or adjuvanted influenza vaccine (secondary).

Main Outcomes and Measures  Stroke risk (nonhemorrhagic stroke, transient ischemic attack, combined outcome of nonhemorrhagic stroke or transient ischemic attack, or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day risk window after vaccination vs the 43- to 90-day control window.

Results  There were 5 397 278 Medicare beneficiaries who received either brand of the COVID-19 bivalent vaccine (median age, 74 years [IQR, 70-80 years]; 56% were women). Among the 11 001 beneficiaries who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine, there were no statistically significant associations between either brand of the COVID-19 bivalent vaccine and the outcomes of nonhemorrhagic stroke, transient ischemic attack, nonhemorrhagic stroke or transient ischemic attack, or hemorrhagic stroke during the 1- to 21-day or 22- to 42-day risk window vs the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12). Among the 4596 beneficiaries who experienced stroke after concomitant administration of either brand of the COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine, there was a statistically significant association between vaccination and nonhemorrhagic stroke during the 22- to 42-day risk window for the Pfizer-BioNTech BNT162b2; WT/OMI BA.4/BA.5 COVID-19 bivalent vaccine (IRR, 1.20 [95% CI, 1.01-1.42]; risk difference/100 000 doses, 3.13 [95% CI, 0.05-6.22]) and a statistically significant association between vaccination and transient ischemic attack during the 1- to 21-day risk window for the Moderna mRNA-1273.222 COVID-19 bivalent vaccine (IRR, 1.35 [95% CI, 1.06-1.74]; risk difference/100 000 doses, 3.33 [95% CI, 0.46-6.20]). Among the 21 345 beneficiaries who experienced stroke after administration of a high-dose or adjuvanted influenza vaccine, there was a statistically significant association between vaccination and nonhemorrhagic stroke during the 22- to 42-day risk window (IRR, 1.09 [95% CI, 1.02-1.17]; risk difference/100 000 doses, 1.65 [95% CI, 0.43-2.87]).

Conclusions and Relevance  Among Medicare beneficiaries aged 65 years or older who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine, there was no evidence of a significantly elevated risk for stroke during the days immediately after vaccination.

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