Liguori Valerio, Zinzi Alessia, Gaio Mario, Riccardi Consiglia, Di Costanzo Luigi, Gargano Francesca, Carpentieri Claudia, D'Elia Maria, Bernardi Francesca Futura, Trama Ugo, Capuano Annalisa, Rafaniello Concetta
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.
Section of Pharmacology "L. Donatelli", Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.
Pharmaceuticals (Basel). 2023 Aug 30;16(9):1231. doi: 10.3390/ph16091231.
Multisystem inflammatory syndrome in children (MIS-c) is an uncommon, but serious, inflammatory response that occurs after SARS-CoV-2 infection. As time went by, MIS-c was also reported as a potential adverse event following COVID-19 vaccination. A descriptive analysis was performed of Individual Case Safety Reports (ICSRs) associated with anti COVID-19 vaccines and related to the pediatric population from 2020 to 2022. The present pharmacovigilance study aimed to describe cases of MIS-c following COVID-19 vaccination, stratified by sex, reported in the Vaccine Adverse Events Reporting System (VAERS) and meeting the Brighton Collaboration criteria for case definition. We assessed all suspected cases through the case definition and classification of the Brighton Collaboration Group, and only definitive, probable, and possible cases were included in the analysis. The Reporting Odds Ratio (ROR) with 95% Confidence Interval (CI) was computed to assess if males have a lower/higher probability of reporting ICSRs with MIS-c compared with females. Overall, we found 79 cases of potentially reported MIS-c following vaccination. This study demonstrated that MIS-c following vaccination was more commonly reported for male subjects with a median age of 10 years (IQR 10.0-11.4), especially after the first dose of anti COVID-19 vaccines with a median time to onset of 27 days. Even so, the rate of occurrence of MIS-c following anti COVID-19 vaccines is lower (0.12/100,000 vaccinated subjects; 95% CI, 0.12-0.13). Overall, all ICSRs were serious and caused or prolonged hospitalization. Finally, disproportionality analysis showed that males had a higher reporting probability of MIS-c compared with females following immunization with mRNA COVID-19 vaccines. Since only a few years of marketing are available, further data from real-life contexts are needed.
儿童多系统炎症综合征（MIS-c）是一种在感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）后发生的罕见但严重的炎症反应。随着时间的推移，MIS-c也被报告为接种2019冠状病毒病（COVID-19）疫苗后的一种潜在不良事件。对2020年至2022年与抗COVID-19疫苗相关且涉及儿科人群的个体病例安全报告（ICSR）进行了描述性分析。本药物警戒研究旨在描述接种COVID-19疫苗后符合布莱顿协作组病例定义标准、按性别分层的MIS-c病例。我们通过布莱顿协作组的病例定义和分类评估了所有疑似病例，分析仅纳入确诊、很可能和可能病例。计算了具有95%置信区间（CI）的报告比值比（ROR），以评估与女性相比，男性报告MIS-c的ICSR的概率是更低还是更高。总体而言，我们发现了79例接种疫苗后潜在报告的MIS-c病例。这项研究表明，接种疫苗后MIS-c更常见于中位年龄为10岁（四分位间距10.0 - 11.4）的男性受试者，尤其是在接种第一剂抗COVID-19疫苗后，中位发病时间为27天。即便如此，抗COVID-19疫苗接种后MIS-c的发生率较低（0.12/100,000接种者；95% CI，0.12 - 0.13）。总体而言，所有ICSR均为严重不良事件，导致或延长了住院时间。最后，不成比例分析表明，与女性相比，男性在接种mRNA COVID-19疫苗后报告MIS-c的概率更高。由于该疫苗上市时间仅数年，还需要来自实际情况的更多数据。
