Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021
Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021
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DOI：
10.1001/jama.2021.24110
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发表时间：
2022-01-25
影响因子：
120.7
通讯作者：
Shimabukuro, Tom T.
中科院分区：
文献类型：
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作者：
Oster, Matthew E.;Shay, David K.;Shimabukuro, Tom T.
重要性接种COVID-19疫苗可带来明确的公共卫生益处，但疫苗接种也存在潜在风险。COVID-19疫苗接种后心肌炎的风险和结果尚不清楚。目的描述美国基于mRNA的COVID-19疫苗接种后心肌炎的报告和报告率。设计，环境，和参与者描述性研究的报告心肌炎的疫苗不良事件报告系统（VAERS）发生后，基于mRNA的COVID-19。2020年12月至2021年8月期间，美国192 405 448名12岁以上的人接种了19种疫苗;数据由VAERS处理到9月30日，2021.暴露BNT 162 b2疫苗接种（Pfizer-BioNTech）或mRNA-1273（Moderna）。主要结果和测量对所有年龄组的VAERS心肌炎报告进行裁定和总结。按年龄和性别分层计算粗报告率。使用2017-2019年索赔数据计算了按年龄和性别划分的心肌炎预期发生率。对于年龄小于30岁的人，进行医疗记录审查和临床医生访谈，以描述临床表现，诊断测试结果，治疗和早期结局。结果在研究期间，192405448人接受了总计354100845种基于mRNA的COVID-19疫苗，有1991例心肌炎报告至VAERS，其中1626例符合心肌炎的病例定义。在心肌炎患者中，中位年龄为21岁（IQR，16-31岁），症状发作的中位时间为2天（IQR，1-3天）。男性占报告性别的心肌炎病例的82%。COVID-19疫苗接种后7天内心肌炎病例的粗报告率超过了多个年龄和性别分层的预期心肌炎率。在12至15岁的青少年男性中，接种第二剂疫苗后心肌炎的发生率最高（每百万剂BNT 162 b2疫苗中有70.7例），16至17岁的青少年男性（每百万剂BNT 162 b2疫苗105.9例），以及18至24岁的年轻男性（BNT 162 b2疫苗和mRNA-1273疫苗分别为每百万剂52.4和56.3）。在30岁以下的患者中，有826例心肌炎病例有详细的临床信息;其中，792/809例（98%）肌钙蛋白水平升高，569/794例（72%）心电图结果异常，223/312例（72%）心脏磁共振成像结果异常。约96%的患者（784/813）住院治疗，其中87%（577/661）的患者出院时症状缓解。最常见的治疗是非甾体抗炎药（589/676; 87%）。结论和相关性基于美国的被动监测报告，在多个年龄和性别分层中，接种基于mRNA的COVID-19疫苗后心肌炎的风险增加，在青少年男性和年轻男性中，第二次接种疫苗后风险最高。这种风险应在COVID-19疫苗接种的益处的背景下加以考虑。
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 dinical presentation, diagnostic test results, treatment, and early outcomes.RESULTS Among 192405 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.