继 Pfizer Inc./BioNTech BNT162b2 和 Moderna mRNA-1273 疫苗于 2020 年 12 月 17 日在美国以及 Janssen Ad26.COV2.S 产品于 4 月 1日在全球推出和管理之后2021 年,以前所未有的方式,数十万人使用疫苗不良事件报告系统 (VAERS) 报告了不良事件 (AE)。我们使用 VAERS 数据来检查在注射第一剂或第二剂 COVID-19 可注射产品后报告的心脏 AE,主要是心肌炎。VAERS 报告的心肌炎发生率在 13 至 23 岁的青年中显着较高(p<0.0001),约 80% 发生在男性中。在向 12-15 岁年龄组公开发售 COVID-19 产品后的 8 周内,我们发现疫苗接种志愿者的心肌炎病例数是该年龄组背景心肌炎发病率的 19 倍。此外,在 15 岁男性中,与第 1 剂相比,第 2 剂的心肌炎发病率增加了 5 倍。总共 67% 的病例发生在 BNT162b2 中。在所有心肌炎 AE 报告中,有 6 人死亡 (1.1%),其中 2 人在 20 岁以下 - 1 人为 13 岁。这些发现表明,使用 COVID-19 注射产品后发生心肌炎的风险明显高于其他人已知的疫苗,这远高于已知的心肌炎背景率。COVID-19 可注射产品是新颖的,具有遗传、致病作用机制,导致 SARS-CoV-2 刺突蛋白在人体细胞内不受控制地表达。当您将此事实与 AE 发生和报告的时间关系、因果关系的生物学合理性以及这些数据在内部和外部与新出现的临床数据来源一致这一事实相结合时,
Following the global rollout and administration of the Pfizer Inc./BioNTech BNT162b2 and Moderna mRNA-1273 vaccines on December 17, 2020, in the United States, and of the Janssen Ad26.COV2.S product on April 1st, 2021, in an unprecedented manner, hundreds of thousands of individuals have reported adverse events (AEs) using the Vaccine Adverse Events Reports System (VAERS). We used VAERS data to examine cardiac AEs, primarily myocarditis, reported following injection of the first or second dose of the COVID-19 injectable products. Myocarditis rates reported in VAERS were significantly higher in youths between the ages of 13 to 23 (p<0.0001) with ∼80% occurring in males. Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males. A total of 67% of all cases occurred with BNT162b2. Of the total myocarditis AE reports, 6 individuals died (1.1%) and of these, 2 were under 20 years of age - 1 was 13. These findings suggest a markedly higher risk for myocarditis subsequent to COVID-19 injectable product use than for other known vaccines, and this is well above known background rates for myocarditis. COVID-19 injectable products are novel and have a genetic, pathogenic mechanism of action causing uncontrolled expression of SARS-CoV-2 spike protein within human cells. When you combine this fact with the temporal relationship of AE occurrence and reporting, biological plausibility of cause and effect, and the fact that these data are internally and externally consistent with emerging sources of clinical data, it supports a conclusion that the COVID-19 biological products are deterministic for the myocarditis cases observed after injection.