Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection.
Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection.
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DOI：
10.1038/s41591-021-01630-0
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发表时间：
2022-03
期刊：
影响因子：
82.9
通讯作者：
Hippisley-Cox J
中科院分区：
文献类型：
--
作者：
Patone M;Mei XW;Handunnetthi L;Dixon S;Zaccardi F;Shankar-Hari M;Watkinson P;Khunti K;Harnden A;Coupland CAC;Channon KM;Mills NL;Sheikh A;Hippisley-Cox J
尽管在2019冠状病毒病（COVID-19）疫苗试验中未观察到心肌炎和心包炎作为不良事件，但在普通人群中接种疫苗后有大量疑似病例的报告。我们对2020年12月1日至2021年8月24日期间在英格兰接种COVID-19疫苗的16岁或以上人群进行了一项自我对照病例系列研究，以调查腺病毒感染后1-28天内因心肌炎、心包炎和心律失常住院或死亡的情况（ChAdOx 1，n = 20，615，911）或基于信使RNA（BNT 162 b2，n = 16，993，389; mRNA-1273，n = 1，006，191）的疫苗或严重急性呼吸综合征冠状病毒2（SARS-CoV-2）阳性检测（n = 3，028，867）。我们发现，在接种后1-28天内，以及SARS-CoV-2阳性检测后，第一剂ChAdOx 1和BNT 162 b2疫苗以及第一剂和第二剂mRNA-1273疫苗的心肌炎风险增加。我们估计还有两个（95%置信区间（CI）0，3），1（95% CI 0，2）和6（95% CI 2.8）分别接种ChAdOx 1、BNT 162 b2和mRNA-1273的每100万人在首次接种后28天和额外接种后10天内的心肌炎事件在第二剂mRNA-1273后的28天内，每100万接种疫苗的人中发生心肌炎事件（95%CI 7，11）。相比之下，在SARS-CoV-2阳性检测后的28天内，每100万名患者中有40例（95% CI 38，41）心肌炎事件。我们还观察到SARS-CoV-2检测阳性后心包炎和心律失常的风险增加。除了第二剂mRNA-1273后心律失常风险增加外，在任何COVID-19疫苗中均未观察到类似的相关性。按年龄进行的亚组分析显示，与两种mRNA疫苗相关的心肌炎风险增加仅存在于40岁以下的人群中。使用来自3800多万16岁及以上人群的个体患者水平数据的自我对照病例系列显示，在接受第一剂ChAdOx 1，BNT 162 b2和mRNA-1273疫苗后一周内心肌炎的风险增加，在第二剂mRNA疫苗后进一步增加。SARS-CoV-2感染与更大的心肌炎、心包炎和心律失常风险相关。
Although myocarditis and pericarditis were not observed as adverse events in coronavirus disease 2019 (COVID-19) vaccine trials, there have been numerous reports of suspected cases following vaccination in the general population. We undertook a self-controlled case series study of people aged 16 or older vaccinated for COVID-19 in England between 1 December 2020 and 24 August 2021 to investigate hospital admission or death from myocarditis, pericarditis and cardiac arrhythmias in the 1–28 days following adenovirus (ChAdOx1, n = 20,615,911) or messenger RNA-based (BNT162b2, n = 16,993,389; mRNA-1273, n = 1,006,191) vaccines or a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (n = 3,028,867). We found increased risks of myocarditis associated with the first dose of ChAdOx1 and BNT162b2 vaccines and the first and second doses of the mRNA-1273 vaccine over the 1–28 days postvaccination period, and after a SARS-CoV-2 positive test. We estimated an extra two (95% confidence interval (CI) 0, 3), one (95% CI 0, 2) and six (95% CI 2, 8) myocarditis events per 1 million people vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, respectively, in the 28 days following a first dose and an extra ten (95% CI 7, 11) myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. This compares with an extra 40 (95% CI 38, 41) myocarditis events per 1 million patients in the 28 days following a SARS-CoV-2 positive test. We also observed increased risks of pericarditis and cardiac arrhythmias following a positive SARS-CoV-2 test. Similar associations were not observed with any of the COVID-19 vaccines, apart from an increased risk of arrhythmia following a second dose of mRNA-1273. Subgroup analyses by age showed the increased risk of myocarditis associated with the two mRNA vaccines was present only in those younger than 40. A self-controlled case series using individual-patient-level data from over 38 million people aged 16 years and over, reveals an increased risk of myocarditis within a week of receiving a first dose of ChAdOx1, BNT162b2 and mRNA-1273 vaccines, which was further increased after a second dose of either mRNA vaccine. SARS-CoV-2 infection was associated with even greater risk of myocarditis, as well as pericarditis and cardiac arrhythmia.
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DOI：
10.1097/ede.0b013e3181d61eeb
发表时间：
2010-05
期刊：
Epidemiology (Cambridge, Mass.)
影响因子：
--
作者：
Lipsitch M;Tchetgen Tchetgen E;Cohen T
通讯作者：
Cohen T
影响因子：
37.8
作者：
Bozkurt, Biykem;Kamat, Ishan;Hotez, Peter J.
通讯作者：
Hotez, Peter J.
影响因子：
37.8
作者：
Kociol, Robb D.;Cooper, Leslie T.;Vardeny, Orly
通讯作者：
Vardeny, Orly
影响因子：
2
作者：
Fonseca-Rodriguez, Osvaldo;Connolly, Anne-Marie Fors;Farrington, Paddy
通讯作者：
Farrington, Paddy
影响因子：
9.3
作者：
De Michieli, Laura;Ola, Olatunde;Sandoval, Yader
通讯作者：
Sandoval, Yader