Ouldali Naïm, Bagheri Haleh, Salvo Francesco, Antona Denise, Pariente Antoine, Leblanc Claire, Tebacher Martine, Micallef Joëlle, Levy Corinne, Cohen Robert, Javouhey Etienne, Bader-Meunier Brigitte, Ovaert Caroline, Renolleau Sylvain, Hentgen Veronique, Kone-Paut Isabelle, Deschamps Nina, De Pontual Loïc, Iriart Xavier, Guen Christelle Gras-Le, Angoulvant François, Belot Alexandre
Assistance Publique-Hôpitaux de Paris, Department of general paediatrics, paediatric infectious disease and internal medicine, Robert Debré university hospital, Université de Paris, Paris, France.
Infectious Diseases Division, CHU Sainte Justine - Montreal University, Montreal, Quebec, Canada.
Lancet Reg Health Eur. 2022 Jun;17:100393. doi: 10.1016/j.lanepe.2022.100393. Epub 2022 Apr 29.
Multisystem inflammatory syndrome in children (MIS-C) is the most severe clinical entity associated with pediatric SARS-CoV-2 infection with a putative role of the spike protein into the immune system activation. Whether COVID-19 mRNA vaccine can induce this complication in children is unknown. We aimed to assess the risk of hyper-inflammatory syndrome following COVID-19 mRNA vaccine in children.
We conducted a post-authorization national population-based surveillance using the French enhanced pharmacovigilance surveillance system for COVID-19 vaccines. All cases of suspected hyper-inflammatory syndrome following COVID-19 mRNA vaccine in 12-17-year-old children between June 15, 2021 and January 1, 2022, were reported. Cases were reviewed according to WHO criteria for MIS-C. The reporting rate of this syndrome was compared to the MIS-C rate per 1,000,000 12-17-year-old children infected by SARS-CoV-2.
Up to January 2022, 8,113,058 COVID-19 mRNA vaccine doses were administered to 4,079,234 12-17-year-old children. Among them, 12 presented a hyper-inflammatory syndrome with multisystemic involvement. Main clinical features included male predominance (10/12, 83%), cardiac involvement (10/12, 83%), digestive symptoms (10/12, 83%), coagulopathy (7/12, 58%), cytolytic hepatitis (6/12, 50%), and shock (5/12, 42%). 4/12 (33%) required intensive care unit transfer, and 3/12 (25%) hemodynamic support. All cases recovered. In eight cases, no evidence of previous SARS-CoV-2 infection was found. The reporting rate was 1.5 (95%CI [0.8; 2.6]) per 1,000,000 doses injected, i.e. 2.9 (95%CI [1.5; 5.1]) per 1,000,000 12-17-year-old vaccinated children. As a comparison, 113 MIS-C (95%CI [95; 135]) occurred per 1,000,000 12-17-year-old children infected by SARS-CoV-2.
Very few cases of hyper-inflammatory syndrome with multi-organ involvement occurred following COVID-19 mRNA vaccine in 12-17-year-old children. The low reporting rate of this syndrome, compared to the rate of post-SARS-CoV-2 MIS-C in the same age-group, largely supports the vaccination in a context of an important circulation of SARS-CoV-2.
ESPID Fellowship Award; Grandir-Fonds de Solidarité Pour L'enfance.
儿童多系统炎症综合征（MIS-C）是与儿童感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）相关的最严重临床实体，刺突蛋白在免疫系统激活中可能发挥作用。2019冠状病毒病（COVID-19）信使核糖核酸（mRNA）疫苗是否会在儿童中引发这种并发症尚不清楚。我们旨在评估儿童接种COVID-19 mRNA疫苗后发生高炎症综合征的风险。
我们利用法国加强的COVID-19疫苗药物警戒监测系统开展了一项基于全国人群的上市后监测。报告了2021年6月15日至2022年1月1日期间12至17岁儿童接种COVID-19 mRNA疫苗后疑似高炎症综合征的所有病例。根据世界卫生组织（WHO）的MIS-C标准对病例进行审查。将该综合征的报告率与每100万例感染SARS-CoV-2的12至17岁儿童中的MIS-C发病率进行比较。
截至2022年1月，4079234名12至17岁儿童接种了8113058剂COVID-19 mRNA疫苗。其中，12例出现多系统受累的高炎症综合征。主要临床特征包括男性居多（12例中的10例，83%）、心脏受累（12例中的10例，83%）、消化系统症状（12例中的10例，83%）、凝血病（12例中的7例，58%）、细胞溶解性肝炎（12例中的6例，50%）和休克（12例中的5例，42%）。12例中有4例（33%）需要转入重症监护病房，12例中有3例（25%）需要血流动力学支持。所有病例均康复。8例病例中未发现既往感染SARS-CoV-2的证据。报告率为每注射100万剂1.5例（95%置信区间[0.8；2.6]），即每100万例接种疫苗的12至17岁儿童中2.9例（95%置信区间[1.5；5.1]）。作为比较，每100万例感染SARS-CoV-2的12至17岁儿童中发生113例MIS-C（95%置信区间[95；135]）。
12至17岁儿童接种COVID-19 mRNA疫苗后，很少发生多器官受累的高炎症综合征。与同年龄组SARS-CoV-2感染后MIS-C的发病率相比，该综合征的低报告率在很大程度上支持在SARS-CoV-2广泛传播的背景下进行疫苗接种。
欧洲儿科感染病学会（ESPID）奖学金；儿童成长团结基金。
