SAEFVIC, Infection and Immunity, Murdoch Children's Research Institute, Parkville, Victoria, Australia
The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
BMJ Paediatr Open. 2022 Jun;6(1). doi: 10.1136/bmjpo-2022-001472.
COVID-19 mRNA vaccine-associated myocarditis has previously been described; however specific features in the adolescent population are currently not well understood.
To describe myocarditis adverse events following immunisation reported following any COVID-19 mRNA vaccines in the adolescent population in Victoria, Australia.
Statewide, population-based study.
Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) is the vaccine-safety service for Victoria, Australia.
All SAEFVIC reports of myocarditis and myopericarditis in 12-17-year-old COVID-19 mRNA vaccinees submitted between 22 February 2021 and 22 February 2022, as well as accompanying diagnostic investigation results where available, were assessed using Brighton Collaboration criteria for diagnostic certainty.
Any mRNA COVID-19 vaccine.
MAIN OUTCOMES/MMEASURE: Confirmed myocarditis as per Brighton Collaboration criteria (levels 1-3).
Clinical review demonstrated definitive (Brighton level 1) or probable (level 2) diagnoses in 75 cases. Confirmed myocarditis reporting rates were 8.3 per 100 000 doses in this age group. Cases were predominantly male (n=62, 82.7%) and post dose 2 (n=61, 81.3%). Rates peaked in the 16-17-year-old age group and were higher in males than females (17.7 vs 3.9 per 100 000, p=<0.001).The most common presenting symptoms were chest pain, dyspnoea and palpitations. A large majority of cases who had a cardiac MRI had abnormalities (n=33, 91.7%). Females were more likely to have ongoing clinical symptoms at 1-month follow-up (p=0.02).
Accurate evaluation and confirmation of episodes of COVID-19 mRNA vaccine-associated myocarditis enabled understanding of clinical phenotypes in the adolescent age group. Any potential vaccination and safety surveillance policies needs to consider age and gender differences.
先前已描述过与 COVID-19 mRNA 疫苗相关的心肌炎；然而，目前对于青少年人群中的具体特征尚不完全清楚。
描述澳大利亚维多利亚州青少年人群中接种任何 COVID-19 mRNA 疫苗后发生的心肌炎不良事件。
全州范围内的基于人群的研究。
接种后社区不良事件监测（SAEFVIC）是澳大利亚维多利亚州的疫苗安全服务。
2021 年 2 月 22 日至 2022 年 2 月 22 日期间，SAEFVIC 报告的 12-17 岁 COVID-19 mRNA 疫苗接种者中所有心肌炎和心肌心包炎病例，以及可用的伴随诊断检查结果，均采用布莱顿合作组织的诊断确定性标准进行评估。
任何 mRNA COVID-19 疫苗。
主要结果/措施：根据布莱顿合作组织标准（1-3 级）确定的确诊心肌炎。
临床审查显示 75 例病例为明确（布莱顿 1 级）或可能（2 级）诊断。该年龄组的确诊心肌炎报告率为每 10 万剂 8.3 例。病例主要为男性（n=62，82.7%）和第 2 剂后（n=61，81.3%）。发病率在 16-17 岁年龄组达到高峰，且男性发病率高于女性（每 100000 人分别为 17.7 和 3.9，p<0.001）。最常见的首发症状是胸痛、呼吸困难和心悸。大多数接受心脏 MRI 的病例均有异常（n=33，91.7%）。在 1 个月随访时，女性更有可能持续出现临床症状（p=0.02）。
准确评估和确认 COVID-19 mRNA 疫苗相关心肌炎发作有助于了解青少年人群中的临床表型。任何潜在的疫苗接种和安全监测政策都需要考虑年龄和性别差异。
