Abstract：
BACKGROUND: The potential association between bivalent COVID-19 vaccination and ischemic stroke remains uncertain, despite several studies conducted thus far.
OBJECTIVE: This study aimed to evaluate the risk of ischemic stroke following bivalent COVID-19 vaccination during the 2022-2023 season.
METHODS: A self-controlled case series study was conducted among members aged 12 years and older who experienced ischemic stroke between September 1, 2022, and March 31, 2023, in a large health care system. Ischemic strokes were identified using International Classification of Diseases, Tenth Revision codes in emergency departments and inpatient settings. Exposures were Pfizer-BioNTech or Moderna bivalent COVID-19 vaccination. Risk intervals were prespecified as 1-21 days and 1-42 days after bivalent vaccination; all non-risk-interval person-time served as the control interval. The incidence of ischemic stroke was compared in the risk interval and control interval using conditional Poisson regression. We conducted overall and subgroup analyses by age, history of SARS-CoV-2 infection, and coadministration of influenza vaccine. When an elevated risk was detected, we performed a chart review of ischemic strokes and analyzed the risk of chart-confirmed ischemic stroke.
RESULTS: With 4933 ischemic stroke events, we found no increased risk within the 21-day risk interval for the 2 vaccines and by subgroups. However, risk of ischemic stroke was elevated within the 42-day risk interval among individuals aged younger than 65 years with coadministration of Pfizer-BioNTech bivalent and influenza vaccines on the same day; the relative incidence (RI) was 2.13 (95% CI 1.01-4.46). Among those who also had a history of SARS-CoV-2 infection, the RI was 3.94 (95% CI 1.10-14.16). After chart review, the RIs were 2.34 (95% CI 0.97-5.65) and 4.27 (95% CI 0.97-18.85), respectively. Among individuals aged younger than 65 years who received Moderna bivalent vaccine and had a history of SARS-CoV-2 infection, the RI was 2.62 (95% CI 1.13-6.03) before chart review and 2.24 (95% CI 0.78-6.47) after chart review. Stratified analyses by sex did not show a significantly increased risk of ischemic stroke after bivalent vaccination.
CONCLUSIONS: While the point estimate for the risk of chart-confirmed ischemic stroke was elevated in a risk interval of 1-42 days among individuals younger than 65 years with coadministration of Pfizer-BioNTech bivalent and influenza vaccines on the same day and among individuals younger than 65 years who received Moderna bivalent vaccine and had a history of SARS-CoV-2 infection, the risk was not statistically significant. The potential association between bivalent vaccination and ischemic stroke in the 1-42-day analysis warrants further investigation among individuals younger than 65 years with influenza vaccine coadministration and prior SARS-CoV-2 infection. Furthermore, the findings on ischemic stroke risk after bivalent COVID-19 vaccination underscore the need to evaluate monovalent COVID-19 vaccine safety during the 2023-2024 season.
OBJECTIVE: This study aimed to evaluate the risk of ischemic stroke following bivalent COVID-19 vaccination during the 2022-2023 season.
METHODS: A self-controlled case series study was conducted among members aged 12 years and older who experienced ischemic stroke between September 1, 2022, and March 31, 2023, in a large health care system. Ischemic strokes were identified using International Classification of Diseases, Tenth Revision codes in emergency departments and inpatient settings. Exposures were Pfizer-BioNTech or Moderna bivalent COVID-19 vaccination. Risk intervals were prespecified as 1-21 days and 1-42 days after bivalent vaccination; all non-risk-interval person-time served as the control interval. The incidence of ischemic stroke was compared in the risk interval and control interval using conditional Poisson regression. We conducted overall and subgroup analyses by age, history of SARS-CoV-2 infection, and coadministration of influenza vaccine. When an elevated risk was detected, we performed a chart review of ischemic strokes and analyzed the risk of chart-confirmed ischemic stroke.
RESULTS: With 4933 ischemic stroke events, we found no increased risk within the 21-day risk interval for the 2 vaccines and by subgroups. However, risk of ischemic stroke was elevated within the 42-day risk interval among individuals aged younger than 65 years with coadministration of Pfizer-BioNTech bivalent and influenza vaccines on the same day; the relative incidence (RI) was 2.13 (95% CI 1.01-4.46). Among those who also had a history of SARS-CoV-2 infection, the RI was 3.94 (95% CI 1.10-14.16). After chart review, the RIs were 2.34 (95% CI 0.97-5.65) and 4.27 (95% CI 0.97-18.85), respectively. Among individuals aged younger than 65 years who received Moderna bivalent vaccine and had a history of SARS-CoV-2 infection, the RI was 2.62 (95% CI 1.13-6.03) before chart review and 2.24 (95% CI 0.78-6.47) after chart review. Stratified analyses by sex did not show a significantly increased risk of ischemic stroke after bivalent vaccination.
CONCLUSIONS: While the point estimate for the risk of chart-confirmed ischemic stroke was elevated in a risk interval of 1-42 days among individuals younger than 65 years with coadministration of Pfizer-BioNTech bivalent and influenza vaccines on the same day and among individuals younger than 65 years who received Moderna bivalent vaccine and had a history of SARS-CoV-2 infection, the risk was not statistically significant. The potential association between bivalent vaccination and ischemic stroke in the 1-42-day analysis warrants further investigation among individuals younger than 65 years with influenza vaccine coadministration and prior SARS-CoV-2 infection. Furthermore, the findings on ischemic stroke risk after bivalent COVID-19 vaccination underscore the need to evaluate monovalent COVID-19 vaccine safety during the 2023-2024 season.
摘要：
背景：二价COVID-19疫苗接种与缺血性卒中之间的潜在关联仍不确定，尽管到目前为止进行了几项研究。
目的：本研究旨在评估2022-2023年期间二价COVID-19疫苗接种后缺血性卒中的风险。
方法：在一个大型医疗保健系统中，对年龄在2022年9月1日至2023年3月31日期间发生缺血性卒中的12岁及以上成员进行了一项自我对照病例系列研究。使用国际疾病分类法确定缺血性中风，急诊科和住院设置的第十次修订代码。暴露是辉瑞生物技术公司或Moderna二价COVID-19疫苗接种。疫苗接种后，风险间隔预设为1-21天和1-42天；所有非风险间隔的人时间作为对照间隔。使用条件泊松回归在风险区间和对照区间比较缺血性卒中的发生率。我们按年龄进行了总体和亚组分析，SARS-CoV-2感染史，和流感疫苗的共同管理。当检测到高风险时，我们对缺血性卒中进行了图表回顾,并分析了图表证实的缺血性卒中的风险.
结果：4933例缺血性卒中事件，我们发现,在21天的风险区间内,2种疫苗和不同亚组的风险均未增加.然而,在年龄小于65岁的个体中,在同一天同时服用Pfizer-BioNTech二价疫苗和流感疫苗的42天风险间隔内,缺血性卒中的风险升高;相对发病率(RI)为2.13(95%CI1.01~4.46).在那些也有SARS-CoV-2感染史的人中，RI为3.94（95%CI1.10-14.16）。经过图表审查，RIs为2.34(95%CI0.97-5.65)和4.27(95%CI0.97-18.85)，分别。在65岁以下接受过Moderna二价疫苗并有SARS-CoV-2感染史的人群中，图表审查前RI为2.62(95%CI1.13-6.03),图表审查后RI为2.24(95%CI0.78-6.47).按性别进行的分层分析未显示二价疫苗接种后缺血性中风的风险显着增加。
结论：虽然在65岁以下同时服用辉瑞-BioNTech二价疫苗和流感疫苗的个体中，以及在65岁以下接受Moderna二价疫苗并有SARS-CoV-2感染史的个体中，经图表证实的缺血性卒中风险的点估计值在1-42天的风险间隔内升高。风险无统计学意义.在1-42天的分析中，二价疫苗接种与缺血性卒中之间的潜在关联值得在65岁以下的合并接种流感疫苗和先前感染SARS-CoV-2的个体中进行进一步调查。此外，双价COVID-19疫苗接种后缺血性卒中风险的研究结果强调了在2023-2024年期间评估单价COVID-19疫苗安全性的必要性.
目的：本研究旨在评估2022-2023年期间二价COVID-19疫苗接种后缺血性卒中的风险。
方法：在一个大型医疗保健系统中，对年龄在2022年9月1日至2023年3月31日期间发生缺血性卒中的12岁及以上成员进行了一项自我对照病例系列研究。使用国际疾病分类法确定缺血性中风，急诊科和住院设置的第十次修订代码。暴露是辉瑞生物技术公司或Moderna二价COVID-19疫苗接种。疫苗接种后，风险间隔预设为1-21天和1-42天；所有非风险间隔的人时间作为对照间隔。使用条件泊松回归在风险区间和对照区间比较缺血性卒中的发生率。我们按年龄进行了总体和亚组分析，SARS-CoV-2感染史，和流感疫苗的共同管理。当检测到高风险时，我们对缺血性卒中进行了图表回顾,并分析了图表证实的缺血性卒中的风险.
结果：4933例缺血性卒中事件，我们发现,在21天的风险区间内,2种疫苗和不同亚组的风险均未增加.然而,在年龄小于65岁的个体中,在同一天同时服用Pfizer-BioNTech二价疫苗和流感疫苗的42天风险间隔内,缺血性卒中的风险升高;相对发病率(RI)为2.13(95%CI1.01~4.46).在那些也有SARS-CoV-2感染史的人中，RI为3.94（95%CI1.10-14.16）。经过图表审查，RIs为2.34(95%CI0.97-5.65)和4.27(95%CI0.97-18.85)，分别。在65岁以下接受过Moderna二价疫苗并有SARS-CoV-2感染史的人群中，图表审查前RI为2.62(95%CI1.13-6.03),图表审查后RI为2.24(95%CI0.78-6.47).按性别进行的分层分析未显示二价疫苗接种后缺血性中风的风险显着增加。
结论：虽然在65岁以下同时服用辉瑞-BioNTech二价疫苗和流感疫苗的个体中，以及在65岁以下接受Moderna二价疫苗并有SARS-CoV-2感染史的个体中，经图表证实的缺血性卒中风险的点估计值在1-42天的风险间隔内升高。风险无统计学意义.在1-42天的分析中，二价疫苗接种与缺血性卒中之间的潜在关联值得在65岁以下的合并接种流感疫苗和先前感染SARS-CoV-2的个体中进行进一步调查。此外，双价COVID-19疫苗接种后缺血性卒中风险的研究结果强调了在2023-2024年期间评估单价COVID-19疫苗安全性的必要性.
