Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital (CHU), 37 Allées Jules Guesde, F-31000 Toulouse, France.
Team PEPSS (Pharmacologie En Population cohorteS et biobanqueS), Centre d'Investigation Clinique 1436, Toulouse University Hospital, France.
Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):99-103. doi: 10.1093/ehjqcco/qcab090.
While some concerns about vaccination-related pericarditis and/or myocarditis have been raised, no published data are available on pericarditis and/or myocarditis with mRNA COVID-19 vaccines in the age group of adolescents, particularly 12-15 years. The objective of this study was to determine whether the risk of reporting pericarditis and/or myocarditis with mRNA COVID-19 vaccines varied according to dose of vaccination, age, sex, and type of pericarditis and/or myocarditis in adolescents between 12 and 17 years.
We performed an observational study reviewing all reports of adolescents vaccinated with mRNA COVID-19 vaccines and recorded in VigiBase®, the World Health Organization global database of individual case safety reports. We included all reports registered between 1 January 2021 and 14 September 2021. Reporting odds ratios (RORs) with their 95% confidence interval (CI) were calculated to estimate the risk of reporting pericarditis and/or myocarditis. Among 4942 reports with mRNA COVID-19 vaccines in adolescents, we identified 242 pericarditis and/or myocarditis. Compared with the first dose of mRNA COVID-19 vaccines, the second dose was associated with an increased risk of reporting pericarditis and/or myocarditis (ROR 4.95; 95% CI 3.14, 7.89). The risk of reporting pericarditis and/or myocarditis was 10 times higher in boys than in girls and no difference between the two types of vaccines could be demonstrated.
This investigation including only adolescent data suggests for the first time that the second dose of mRNA COVID-19 vaccines increases the risk of reporting myocarditis/pericarditis compared with the first dose particularly in boys without significant difference between tozinameran and elasomeran.
虽然人们对疫苗相关的心包炎和/或心肌炎提出了一些担忧,但目前尚无关于青少年(尤其是 12-15 岁)接种 mRNA COVID-19 疫苗后发生心包炎和/或心肌炎的发表数据。本研究的目的是确定在 12 至 17 岁的青少年中,mRNA COVID-19 疫苗接种的心包炎和/或心肌炎报告风险是否因接种剂量、年龄、性别以及心包炎和/或心肌炎的类型而异。
我们进行了一项观察性研究,回顾了所有在世界卫生组织全球个体病例安全报告数据库 VigiBase®中记录的青少年接种 mRNA COVID-19 疫苗后出现的心包炎和/或心肌炎报告。我们纳入了 2021 年 1 月 1 日至 2021 年 9 月 14 日期间登记的所有报告。计算报告比值比(ROR)及其 95%置信区间(CI)以估计报告心包炎和/或心肌炎的风险。在 4942 例青少年接种 mRNA COVID-19 疫苗的报告中,我们发现 242 例心包炎和/或心肌炎。与接种 mRNA COVID-19 疫苗的第一剂相比,第二剂与报告心包炎和/或心肌炎的风险增加相关(ROR 4.95;95%CI 3.14,7.89)。男孩报告心包炎和/或心肌炎的风险是女孩的 10 倍,且无法证明两种疫苗之间存在差异。
本项仅纳入青少年数据的研究首次表明,与第一剂相比,mRNA COVID-19 疫苗的第二剂增加了报告心肌炎/心包炎的风险,特别是在男孩中,而托珠单抗和埃洛莫单抗之间无显著差异。