2020年12月至2021 8月美国基于mRNA的新型冠状病毒疫苗接种后报告的心肌炎病例

要点

问：在美国接种基于mRNA的新型冠状病毒疫苗后，心肌炎的风险是什么？

结果在这项对全国被动报告系统中1626例心肌炎病例的描述性研究中，接种疫苗后7天内的粗略报告率超过了多个年龄和性别阶层的预期率。接种第二剂疫苗后，12至15岁的青少年男性（每百万剂BNT162b2疫苗70.7人）、16至17岁的青少年男子（每百万剂量BNT162b2疫苗105.9人）和18至24岁的年轻男子（每一百万剂BNT162 b2疫苗52.4人和mRNA-1273疫苗56.3人）心肌炎发病率最高。

根据美国的被动监测报告，接受基于mRNA的新型冠状病毒疫苗后的心肌炎风险在多个年龄层和性别层增加，在第二次接种剂量后，青少年男性和年轻男性心肌炎的风险最高。

摘要

预防新冠肺炎疫苗的重要性提供了明显的公共卫生益处，但疫苗接种也具有潜在风险。接种新冠肺炎疫苗后心肌炎的风险和结果尚不清楚。

目的描述美国新冠肺炎（COVID-19）mRNA疫苗接种后心肌炎的报告情况和报告率。

设计、设置和参与者对2020年12月至2021 8月接种基于mRNA的新型冠状病毒疫苗后向疫苗不良事件报告系统（VAERS）报告心肌炎的描述性研究192 405 美国有448名12岁以上的人；截至2021 9月30日，数据由VAERS处理。

接触BNT162b2（Pfizer BioNTech）或mRNA-1273（Moderna）疫苗接种。

对所有年龄组的VAERS心肌炎报告进行了裁决和总结。粗报告率是按年龄和性别阶层计算的。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病率。对于年龄小于30岁的患者，进行病历审查和临床医师访谈，以描述临床表现、诊断测试结果、治疗和早期结果。

192项结果 405 448人共接待354人 100 在研究期间，845份基于mRNA的新型冠状病毒疫苗，1991份向VAERS报告了心肌炎，其中1626份符合心肌炎病例定义。心肌炎患者的中位年龄为21岁（IQR，16-31岁），症状出现的中位时间为2天（IQR）。男性占报告性心肌炎病例的82%。新冠肺炎疫苗接种后7天内心肌炎病例的粗略报告率超过了多年龄层和性别层心肌炎的预期发病率。接种第二剂疫苗后，12至15岁的青少年男性（每百万剂BNT162b2疫苗接种70.7次）、16至17岁的青少年男子（每百万剂量BNT162b2疫苗接种105.9次）和18至24岁的年轻男子（每一百万剂BNT162 b2疫苗和mRNA-1273疫苗接种52.4次和56.3次）的心肌炎发病率最高。30岁以下的患者中有826例心肌炎，他们有详细的临床信息；在这些病例中，809例（98%）中有792例肌钙蛋白水平升高，794例（72%）中有569例心电图结果异常，312例中有223例心脏磁共振成像结果异常。约96%的人（784/813）住院，其中87%（577/661）出院后症状缓解。最常见的治疗方法是非甾体抗炎药（589/676；87%）。

结论和相关性根据美国被动监测报告，接受基于mRNA的新型冠状病毒疫苗后的心肌炎风险在多个年龄层和性别层增加，在第二次接种后最高

Original Investigation

January 25, 2022

Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021

Matthew E. Oster, MD, MPH1,2,3; David K. Shay, MD, MPH1; John R. Su, MD, PhD, MPH1; et alJulianne Gee, MPH1; C. Buddy Creech, MD, MPH4; Karen R. Broder, MD1; Kathryn Edwards, MD4; Jonathan H. Soslow, MD, MSCI4; Jeffrey M. Dendy, MD4; Elizabeth Schlaudecker, MD, MPH5; Sean M. Lang, MD5; Elizabeth D. Barnett, MD6; Frederick L. Ruberg, MD6; Michael J. Smith, MD, MSCE7; M. Jay Campbell, MD, MHA7; Renato D. Lopes, MD, PhD, MHS7; Laurence S. Sperling, MD1,2; Jane A. Baumblatt, MD8; Deborah L. Thompson, MD, MSPH8; Paige L. Marquez, MSPH1; Penelope Strid, MPH1; Jared Woo, MPH1; River Pugsley, PhD, MPH1; Sarah Reagan-Steiner, MD, MPH1; Frank DeStefano, MD, MPH1; Tom T. Shimabukuro, MD, MPH, MBA1

Author Affiliations Article Information

JAMA. 2022;327(4):331-340. doi:10.1001/jama.2021.24110

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Key Points

Question  What is the risk of myocarditis after mRNA-based COVID-19 vaccination in the US?

Findings  In this descriptive study of 1626 cases of myocarditis in a national passive reporting system, the crude reporting rates within 7 days after vaccination exceeded the expected rates across multiple age and sex strata. The rates of myocarditis cases 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).

Meaning  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.

Abstract

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.