Kitano Taito, Salmon Daniel A, Dudley Matthew Z, Saldanha Ian J, Thompson David A, Engineer Lilly
Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, United States.
Department of Pediatrics, Nara Prefecture General Medical Center, Nara 630-8054, Japan.
Epidemiol Rev. 2025 Jan 10;47(1):1-11. doi: 10.1093/epirev/mxae007.
Although COVID-19 vaccines are generally very safe, the risks of myocarditis and pericarditis after receiving an messenger RNA (mRNA) vaccine have been established, with the highest risk in young men. Most systematic reviews and meta-analyses of the risk of myocarditis or pericarditis have included passive surveillance data, which is subject to reporting errors. Accurate measures of age-, sex-, and vaccine dose- and type-specific risks are crucial for assessment of the benefits and risks of the vaccination. A systematic review and meta-analysis of the risks of myocarditis and pericarditis attributable COVID-19 vaccines were conducted, stratified by age groups, sex, vaccine type, and vaccine dose. Five electronic databases and gray literature sources were searched on November 21, 2023. Article about studies that compared a COVID-19-vaccinated group with an unvaccinated group or time period (eg, self-controlled) were included. Passive surveillance data were excluded. Meta-analyses were conducted using random-effects models. A total of 4030 records were identified; ultimately, 17 articles were included in this review. Compared with unvaccinated groups or unvaccinated time periods, the highest attributable risk of myocarditis or pericarditis was observed after the second dose in boys aged 12-17 years (10.18 per 100 000 doses [95% CI, 0.50-19.87]) of the BNT162b2 vaccine and in young men aged 18-24 years (attributable risk, 20.02 per 100 000 doses [95% CI, 10.47-29.57]) for the mRNA-1273 vaccine. The stratified results based on active surveillance data provide the most accurate available estimates of the risks of myocarditis and pericarditis attributable to specific COVID-19 vaccinations for specific populations. Trial registration: International Prospective Register of Systematic Reviews (PROSPERO) Identifier: CRD42023443343.
尽管新冠病毒疫苗总体上非常安全，但接种信使核糖核酸（mRNA）疫苗后发生心肌炎和心包炎的风险已得到确认，在年轻男性中风险最高。大多数关于心肌炎或心包炎风险的系统评价和荟萃分析纳入了被动监测数据，而这类数据存在报告误差。准确衡量年龄、性别、疫苗剂量和类型特异性风险对于评估疫苗接种的利弊至关重要。我们开展了一项关于新冠病毒疫苗所致心肌炎和心包炎风险的系统评价和荟萃分析，并按年龄组、性别、疫苗类型和疫苗剂量进行分层。2023年11月21日检索了五个电子数据库和灰色文献来源。纳入了比较接种新冠病毒疫苗组与未接种疫苗组或时间段（如自身对照）的研究文章。排除被动监测数据。使用随机效应模型进行荟萃分析。共识别出4030条记录；最终，本评价纳入了17篇文章。与未接种疫苗组或未接种疫苗时间段相比，12至17岁男孩接种BNT162b2疫苗第二剂后心肌炎或心包炎的最高归因风险为每10万剂10.18例（95%CI，0.50 - 19.87），18至24岁年轻男性接种mRNA - 1273疫苗后为每10万剂20.02例（95%CI，10.47 - 29.57）。基于主动监测数据的分层结果为特定人群中特定新冠病毒疫苗所致心肌炎和心包炎风险提供了最准确的现有估计。试验注册：国际系统评价前瞻性注册库（PROSPERO）标识符：CRD42023443343。
