加强接种 SARS-CoV-2 mRNA 疫苗与青少年和青年成年人心肌炎：一项北欧队列研究。

Booster vaccination with SARS-CoV-2 mRNA vaccines and myocarditis in adolescents and young adults: a Nordic cohort study.

机构信息

Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen, Denmark.

Department of Drug Design and Pharmacology, Pharmacovigilance Research Center, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.

出版信息

Eur Heart J. 2024 Apr 14;45(15):1327-1335. doi: 10.1093/eurheartj/ehae056.

DOI:10.1093/eurheartj/ehae056

PMID:38365960

Abstract

BACKGROUND AND AIMS

The SARS-CoV-2 mRNA vaccines are associated with an increased risk of myocarditis. This association appears to be strongest in male adolescents and younger males and after the second dose. The aim was to evaluate the risk of myocarditis following SARS-CoV-2 mRNA booster vaccination in 12-to-39-year-olds.

METHODS

A multinational cohort study was conducted using nationwide register data in Denmark, Finland, Norway, and Sweden and comprising all 8.9 million individuals residing in each of the four countries. Participants were followed for an inpatient diagnosis of myocarditis. In each of the four countries, Poisson regression was used to estimate adjusted incidence rate ratios (IRRs) of myocarditis comparing vaccination schedules, with associated 95% confidence intervals (CIs). Country-specific results were combined in meta-analyses.

RESULTS

A total of 8.9 million residents were followed for 12 271 861 person-years and 1533 cases of myocarditis were identified. In 12-to-39-year-old males, the 28-day acute risk period following the third dose of BNT162b2 or mRNA-1273 was associated with an increased incidence rate of myocarditis compared to the post-acute risk period 28 days or more after the second dose [IRR 2.08 (95% CI 1.31-3.33) and 8.89 (2.26-35.03), respectively]. For females, the corresponding IRR was only estimable for BNT162b2, 3.99 (0.41-38.64). The corresponding absolute risks following the third dose of BNT162b2 and mRNA-1273 in males were 0.86 (95% CI 0.53-1.32) and 1.95 (0.53-4.99) myocarditis events within 28 days per 100 000 individuals vaccinated, respectively. In females, the corresponding absolute risks following the third dose of BNT162b2 were 0.15 (0.04-0.39) events per 100 000 individuals vaccinated. No deaths occurred within 30 days of vaccine-related cases.

CONCLUSIONS

The results suggest that a booster dose is associated with increased myocarditis risk in adolescents and young adults. However, the absolute risk of myocarditis following booster vaccination is low.

摘要

背景与目的

SARS-CoV-2 mRNA 疫苗与心肌炎风险增加相关。这种关联似乎在男性青少年和年轻男性中最强，并且在第二剂之后。目的是评估 12 至 39 岁人群接受 SARS-CoV-2 mRNA 加强疫苗接种后的心肌炎风险。

方法

这项多国队列研究使用丹麦、芬兰、挪威和瑞典的全国登记数据进行，包括每个国家的 890 万居民。参与者因心肌炎住院接受诊断。在每个国家，都使用泊松回归来估计比较接种方案的心肌炎调整发病率比值（IRR），并伴有 95%置信区间（CI）。在荟萃分析中结合了各国的结果。

结果

共有 890 万居民随访了 12271861 人年，发现了 1533 例心肌炎病例。在 12 至 39 岁的男性中，与第二剂后 28 天的急性风险期相比，第三剂 BNT162b2 或 mRNA-1273 后 28 天或更久的急性风险期与心肌炎的发生率增加相关[IRR 分别为 2.08（95%CI 1.31-3.33）和 8.89（2.26-35.03）]。对于女性，BNT162b2 的相应 IRR 仅可估计，为 3.99（0.41-38.64）。在男性中，接种 BNT162b2 和 mRNA-1273 后第三剂的相应绝对风险分别为每 100000 名接种者 0.86（95%CI 0.53-1.32）和 1.95（0.53-4.99）的心肌炎事件。在女性中，接种 BNT162b2 后第三剂的相应绝对风险为每 100000 名接种者 0.15（0.04-0.39）的心肌炎事件。在疫苗相关病例发生后 30 天内没有死亡。