Takada Keisuke, Taguchi Kazuaki, Samura Masaru, Igarashi Yuki, Okamoto Yuko, Enoki Yuki, Tanikawa Koji, Matsumoto Kazuaki
Division of Pharmacodynamics, Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan; Department of Pharmacy, Yokohama General Hospital, 2201-5 Kuroganecho, Aoba-ku, Yokohama City, Kanagawa, 225-0025, Japan.
Division of Pharmacodynamics, Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan.
J Infect Chemother. 2025 Jan;31(1):102485. doi: 10.1016/j.jiac.2024.07.025. Epub 2024 Aug 3.
The association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines and myocarditis/pericarditis in the Japanese population has not been systematically investigated. This study was aimed at clarifying the association between SARS-CoV-2 mRNA vaccines (BNT162b2 and mRNA-1273) and myocarditis/pericarditis as well as influencing factors by using the Japanese Adverse Drug Event Report database.
Reporting odds ratios (RORs) and 95 % confidence intervals (95 % CIs) for the association between the vaccines and myocarditis/pericarditis were calculated using data from the database (April 2004-December 2023). Age, sex, onset time, and outcomes in symptomatic patients were evaluated.
The total number of reports was 880,999 (myocarditis: 1846; pericarditis: 761). The adverse events associated with the vaccines included myocarditis (919 cases) and pericarditis (321 cases), with the ROR [95 % CIs] being significant for both (myocarditis: 30.51 [27.82-33.45], pericarditis: 21.99 [19.03-25.40]). Furthermore, the ROR [95 % CIs] of BNT162b2 and mRNA-1273 were 15.64 [14.15-17.28] and 54.23 [48.13-61.10], respectively, for myocarditis, and 15.78 [13.52-18.42] and 27.03 [21.58-33.87], respectively, for pericarditis. Furthermore, most cases were ≤30 years or male. The period from vaccination to onset was ≤8 days, corresponding to early failure type based on analysis using the Weibull distribution. Outcomes were recovery or remission for most cases; however, they were severe or caused death in some cases.
In the Japanese population, SARS-CoV-2 mRNA vaccination was significantly associated with the onset of myocarditis/pericarditis. The influencing factors included age of ≤30 years and male. Furthermore, although most adverse events occurred early after vaccination, overall outcomes were good.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）mRNA疫苗与日本人群中心肌炎/心包炎之间的关联尚未得到系统研究。本研究旨在利用日本药品不良事件报告数据库，阐明SARS-CoV-2 mRNA疫苗（BNT162b2和mRNA-1273）与心肌炎/心包炎之间的关联以及影响因素。
使用数据库（2004年4月至2023年12月）中的数据计算疫苗与心肌炎/心包炎之间关联的报告比值比（ROR）和95%置信区间（95%CI）。对有症状患者的年龄、性别、发病时间和结局进行评估。
报告总数为880,999份（心肌炎：1846例；心包炎：761例）。与疫苗相关的不良事件包括心肌炎（919例）和心包炎（321例），两者的ROR[95%CI]均具有统计学意义（心肌炎：30.51[27.82 - 33.45]，心包炎：21.99[19.03 - 25.40]）。此外，BNT162b2和mRNA-1273对于心肌炎的ROR[95%CI]分别为15.64[14.15 - 17.28]和54.23[48.13 - 61.10]，对于心包炎的ROR[95%CI]分别为15.78[13.52 - 18.42]和27.03[21.58 - 33.87]。此外，大多数病例年龄≤30岁或为男性。从接种疫苗到发病的时间≤8天，根据使用威布尔分布的分析，这属于早期失效类型。大多数病例的结局为恢复或缓解；然而，在某些情况下病情严重或导致死亡。
在日本人群中，SARS-CoV-2 mRNA疫苗接种与心肌炎/心包炎的发病显著相关。影响因素包括年龄≤30岁和男性。此外，尽管大多数不良事件在接种疫苗后早期发生，但总体结局良好。
