Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel.
Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel.
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DOI：
10.1056/nejmoa2109730
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发表时间：
2021-12-02
期刊：
影响因子：
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通讯作者：
Alroy-Preis S
中科院分区：
文献类型：
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作者：
Mevorach D;Anis E;Cedar N;Bromberg M;Haas EJ;Nadir E;Olsha-Castell S;Arad D;Hasin T;Levi N;Asleh R;Amir O;Meir K;Cohen D;Dichtiar R;Novick D;Hershkovitz Y;Dagan R;Leitersdorf I;Ben-Ami R;Miskin I;Saliba W;Muhsen K;Levi Y;Green MS;Keinan-Boker L;Alroy-Preis S
截至2021年5月31日，约有510万以色列人在接种两剂BNT162b2信使RNA疫苗（辉瑞-BioNTech）后，已对2019冠状病毒病（Covid-19）进行了全面免疫接种。在不良事件监测期间出现心肌炎的早期报告后，以色列卫生部启动了积极监测。我们回顾性审查了2020年12月20日至2021年5月31日期间获得的关于所有心肌炎病例的数据，并使用布莱顿协作定义对信息进行分类。我们通过计算第一剂和第二剂疫苗接种后发生率的风险差异来分析心肌炎的发生（间隔21天）;通过计算首次给药后21天内和第二次给药后30天内的预测发生率与预期发生率的标准化发生率比，与诊断确定性无关;并通过计算第二次接种后30天与未接种者相比的比率。在304名有心肌炎症状的人中，21人接受了替代诊断。在其余283例病例中，142例发生在接种BNT162b2疫苗后;其中136例诊断为明确或可能。129名受者（95%）的临床表现被判定为轻度; 1例暴发性病例是致命的。第一剂和第二剂之间的总体风险差异为1.76/100，000人（95%置信区间[CI]，1.33至2.19），其中16至19岁男性受试者之间的差异最大（差异为13.73/100，000人; 95% CI，8.11至19.46）。与基于历史数据的预期发生率相比，标准化发生率比为5.34（95% CI，4.48 - 6.40），在16 - 19岁男性受试者中第二次给药后最高（13.60; 95% CI，9.30 - 19.20）。与未接种者相比，完全接种者第二剂疫苗接种后30天的比率为2.35（95% CI，1.10 - 5.02）; 16 - 19岁男性接种者的比率再次最高（8.96; 95% CI，4.50 - 17.83），比率为1/6637。心肌炎的发病率虽然较低，但在接种BNT162b2疫苗后增加，特别是在年轻男性接种者中接种第二剂疫苗后。接种疫苗后心肌炎的临床表现通常是轻微的。
Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance. We retrospectively reviewed data obtained from December 20, 2020, to May 31, 2021, regarding all cases of myocarditis and categorized the information using the Brighton Collaboration definition. We analyzed the occurrence of myocarditis by computing the risk difference for the comparison of the incidence after the first and second vaccine doses (21 days apart); by calculating the standardized incidence ratio of the observed-to-expected incidence within 21 days after the first dose and 30 days after the second dose, independent of certainty of diagnosis; and by calculating the rate ratio 30 days after the second dose as compared with unvaccinated persons. Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637. The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.