Rose Jessica, Hulscher Nicolas, McCullough Peter A
Independent Researcher, Ontario, Canada.
University of Michigan School of Public Health, 1415 Washington Heights, Ann Arbor, MI 48109, USA.
Ther Adv Drug Saf. 2024 Jan 27;15:20420986241226566. doi: 10.1177/20420986241226566. eCollection 2024.
Following the roll-out of the Pfizer-BioNTech BNT162b2, Moderna mRNA-1273, and Janssen Ad26.COV2.S coronavirus disease 2019 (COVID-19) injections in the United States, millions of individuals have reported adverse events (AEs) using the vaccine adverse events reports system (VAERS). The objective of this analysis is to describe the myocarditis data in VAERS and the COVID-19 vaccines as potential determinants of myocarditis.
We used VAERS data to examine the frequency of reporting myocarditis since the beginning of the mass vaccination campaign and compared this with historical values in VAERS and COVID-19 vaccine administration data from the Our World in Data database. We examined myocarditis reports in VAERS in the context of sex, age, and dose. Statistical analysis was done using the Student's test to determine statistically significant differences between ages among myocarditis adverse events (AEs) and the chi-square test to determine relationships between categorical variables with statistical significance.
We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years. This represented a 2500% increase in the absolute number of reports in the first year of the campaign when comparing historical values prior to 2021. Demographic data revealed that myocarditis occurred most in youths (50%) and males (69%). A total of 76% of cases resulted in emergency care and hospitalization. Of the total myocarditis reports, 92 individuals died (3%). Myocarditis was more likely after dose 2 ( < 0.00001) and individuals less than 30 years of age were more likely than individuals older than 30 to acquire myocarditis ( < 0.00001).
COVID-19 vaccination is strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death. Further investigation into the underlying mechanisms of COVID-19 vaccine-induced myocarditis is imperative to create effective mitigation strategies and ensure the safety of COVID-19 vaccination programs across populations.
在美国推出辉瑞 - 生物科技公司的BNT162b2、莫德纳公司的mRNA - 1273和杨森公司的Ad26.COV2.S新型冠状病毒肺炎（COVID - 19）疫苗后，数以百万计的人通过疫苗不良事件报告系统（VAERS）报告了不良事件（AE）。本分析的目的是描述VAERS中关于心肌炎的数据以及COVID - 19疫苗作为心肌炎潜在决定因素的情况。
我们使用VAERS数据来检查自大规模疫苗接种运动开始以来心肌炎的报告频率，并将其与VAERS中的历史值以及来自“Our World in Data”数据库的COVID - 19疫苗接种数据进行比较。我们在性别、年龄和剂量的背景下检查了VAERS中的心肌炎报告。使用学生检验进行统计分析以确定心肌炎不良事件（AE）各年龄组之间的统计学显著差异，并使用卡方检验确定具有统计学意义的分类变量之间的关系。
我们发现2021年COVID - 19疫苗接种后VAERS中心肌炎报告数量比过去30年所有疫苗报告数量总和的平均值高出223倍。与2021年之前的历史值相比，这代表了接种运动第一年报告绝对数量增加了2500%。人口统计学数据显示，心肌炎在年轻人（50%）和男性（69%）中最为常见。共有76%的病例导致了紧急护理和住院治疗。在所有心肌炎报告中，92人死亡（3%）。接种第二剂后发生心肌炎的可能性更大（<0.00001），并且年龄小于30岁的个体比30岁以上的个体更容易患心肌炎（<0.00001）。
COVID - 19疫苗接种与心肌炎这一严重不良安全信号密切相关，尤其是在儿童和年轻人中，会导致住院和死亡。必须进一步调查COVID - 19疫苗诱导心肌炎的潜在机制，以制定有效的缓解策略，并确保COVID - 19疫苗接种计划在人群中的安全性。
