US Centers for Disease Control and Prevention, Atlanta, Georgia.
School of Medicine, Emory University, Atlanta, Georgia.
JAMA. 2022 Jan 25;327(4):331-340. doi: 10.1001/jama.2021.24110.
IMPORTANCE: Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear. OBJECTIVE: To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US. DESIGN, SETTING, AND PARTICIPANTS: Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021. EXPOSURES: Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna). MAIN OUTCOMES AND MEASURES: Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes. RESULTS: Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%). CONCLUSIONS AND RELEVANCE: Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.
重要性:接种 COVID-19 疫苗具有明显的公共卫生益处,但接种疫苗也存在潜在风险。COVID-19 疫苗接种后心肌炎的风险和结果尚不清楚。 目的:描述美国 mRNA 新冠疫苗接种后心肌炎的报告和报告率。 设计、设置和参与者:描述性研究,对美国 12 岁以上的 192405448 名个体在 2020 年 12 月至 2021 年 8 月期间接种 mRNA 新冠疫苗后向疫苗不良事件报告系统(VAERS)报告的心肌炎病例;截至 2021 年 9 月 30 日,VAERS 对数据进行了处理。 暴露:接种 BNT162b2(辉瑞-生物技术)或 mRNA-1273(莫德纳)。 主要结果和措施:VAERS 对心肌炎病例进行了裁决和总结,涵盖所有年龄组。根据年龄和性别分层计算了粗报告率。使用 2017-2019 年的索赔数据计算了预期的心肌炎发生率。对于年龄小于 30 岁的人群,进行了病历回顾和临床医生访谈,以描述临床表现、诊断试验结果、治疗和早期结果。 结果:在研究期间,192405448 名接受了 354100845 剂 mRNA 新冠疫苗的人中,有 1991 份心肌炎报告提交给 VAERS,其中 1626 份符合心肌炎的病例定义。在患有心肌炎的患者中,中位年龄为 21 岁(IQR,16-31 岁),症状出现的中位时间为 2 天(IQR,1-3 天)。在报告心肌炎的病例中,男性占 82%,报告了性别。COVID-19 疫苗接种后 7 天内心肌炎的粗报告率超过了多个年龄和性别分层的预期心肌炎发生率。在 12 至 15 岁的青少年男性、16 至 17 岁的青少年男性和 18 至 24 岁的年轻男性中,第二剂疫苗接种后心肌炎的发生率最高(BNT162b2 疫苗每百万剂 70.7 例,BNT162b2 疫苗和 mRNA-1273 疫苗每百万剂分别为 105.9 和 52.4-56.3 例)。在年龄小于 30 岁且有详细临床信息的 826 例心肌炎患者中,其中 792 例(809 例的 98%)肌钙蛋白水平升高,569 例(794 例的 72%)心电图结果异常,223 例(312 例的 72%)心脏磁共振成像结果异常。大约 96%(784/813)的患者住院,其中 87%(577/661)的患者在出院时症状缓解。最常见的治疗方法是非甾体抗炎药(589/676;87%)。 结论和相关性:基于美国的被动监测报告,mRNA 新冠疫苗接种后心肌炎的风险在多个年龄和性别分层中增加,在青少年男性和年轻男性中第二剂疫苗接种后最高。在考虑 COVID-19 疫苗接种的益处时,应考虑到这一风险。
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