Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel

被引:461
作者
Mevorach, D. [1 ,2 ,3 ]
Anis, E. [7 ,10 ]
Cedar, N. [10 ]
Bromberg, M. [13 ,17 ]
Haas, E. J. [10 ,19 ]
Nadir, E. [10 ,14 ]
Olsha-Castell, S. [11 ]
Arad, D. [11 ]
Hasin, T. [8 ]
Levi, N. [8 ]
Asleh, R. [4 ]
Amir, O. [4 ,15 ,16 ]
Meir, K. [5 ]
Cohen, D. [6 ]
Dichtiar, R. [13 ]
Novick, D. [13 ]
Hershkovitz, Y. [13 ]
Dagan, R. [19 ]
Leitersdorf, I [12 ]
Ben-Ami, R. [18 ]
Miskin, I [9 ,14 ]
Saliba, W. [20 ]
Muhsen, K. [17 ]
Levi, Y. [13 ]
Green, M. S. [21 ]
Keinan-Boker, L. [13 ,21 ]
Alroy-Preis, S. [13 ]
机构
[1] Hadassah Hebrew Univ Med Ctr, Jerusalem, Israel
[2] Hadassah Med Ctr, Dept Internal Med B, Div Immunol Rheumatol, Jerusalem, Israel
[3] Hadassah Med Ctr, Inst Translat Med, Jerusalem, Israel
[4] Hadassah Med Ctr, Dept Cardiol, Jerusalem, Israel
[5] Hadassah Med Ctr, Dept Pathol, Jerusalem, Israel
[6] Hadassah Med Ctr, Dept Radiol, Jerusalem, Israel
[7] Hebrew Univ Jerusalem, Fac Med, Braun Sch Publ Hlth, Jerusalem, Israel
[8] Hebrew Univ Jerusalem, Fac Med, Jesselson Integrated Heart Ctr, Shaare Zedek Med Ctr, Jerusalem, Israel
[9] Hebrew Univ Jerusalem, Fac Med, Dept Family Med, Jerusalem, Israel
[10] Div Epidemiol, Jerusalem, Israel
[11] Div Patient Safety, Jerusalem, Israel
[12] Div Med, Jerusalem, Israel
[13] Israeli Minist Hlth, Jerusalem, Israel
[14] Clalit Hlth Serv, Jerusalem, Israel
[15] Bar Ilan Univ, Israel Ctr Dis Control, Ramat Gan, Israel
[16] Bar Ilan Univ, Azrieli Fac Med, Ramat Gan, Israel
[17] Tel Aviv Univ, Dept Epidemiol & Prevent Med, Sch Publ Hlth, Tel Aviv, Israel
[18] Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, Tel Aviv, Israel
[19] Ben Gurion Univ Negev, Beer Sheva, Israel
[20] Technion Israel Inst Technol, Lady Davis Carmel Med Ctr, Dept Community Med & Epidemiol, Haifa, Israel
[21] Univ Haifa, Sch Publ Hlth, Haifa, Israel
关键词
D O I
10.1056/NEJMoa2109730
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Myocarditis after BNT162b2 Vaccine in Israel In an Israeli Ministry of Health database, 136 definite or probable cases of myocarditis were detected among 5 million vaccinated persons. The rate ratio after two doses as compared with unvaccinated persons was 2.35, with the highest risk among male recipients between the ages of 16 and 19 years. Background 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. Methods 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. Results 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. Conclusions 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.
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页码:2140 / 2149
页数:10
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