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Journal Articles The Lancet Regional Health - Europe Year : 2022

Hyper inflammatory syndrome following COVID-19 mRNA vaccine in children: A national post-authorization pharmacovigilance study

1 Hôpital Robert Debré
2 CHU Sainte Justine [Montréal]
3 ACTIV - Association Clinique et Thérapeutique Infantile du Val de Marne
4 ECEVE (U1123 / UMR_S_1123) - Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables
5 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
6 BPH - Bordeaux population health
7 CHU Bordeaux
8 Santé publique France - French National Public Health Agency [Saint-Maurice, France]
9 HUS - Les Hôpitaux Universitaires de Strasbourg
10 CHU Marseille
11 INS - Institut de Neurosciences des Systèmes
12 CHI Créteil
13 IMRB - Institut Mondor de Recherche Biomédicale
14 HFME - Hôpital Femme Mère Enfant [CHU - HCL]
15 PI3 - Physiopathologie de l'immunodépression associée aux réponses inflammatoires systémiques / Pathophysiology of Injury-induced Immunosuppression
16 Hôpital Necker - Enfants Malades [AP-HP]
17 RAISE - Centre de Référence pour les Maladies Rhumatologiques Auto-Immunes et Systémiques [CHU Necker]
18 Imagine - U1163 - Imagine - Institut des maladies génétiques (IHU)
19 TIMONE - Hôpital de la Timone [CHU - APHM]
20 MMG - Marseille medical genetics - Centre de génétique médicale de Marseille
21 EA_7323 - Evaluation thérapeutique et pharmacologie périnatale et pédiatrique
22 CHV - Centre Hospitalier de Versailles André Mignot
23 CeRéMAIA - Hôpital André Mignot - Centre de Référence des Maladies Auto-Inflammatoires et des Amyloses [CH Versailles]
24 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
25 Université Paris-Saclay
26 CH de Saint-Malo [Broussais]
27 Hôpital Jean Verdier [AP-HP]
28 IHU Liryc - Institut de rythmologie et modélisation cardiaque [Pessac]
29 CRCTB - Centre de recherche Cardio-Thoracique de Bordeaux [Bordeaux]
30 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
31 CRESS (U1153 / UMR_A 1125) - Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques
32 CIC Nantes - Centre d’Investigation Clinique de Nantes
33 CRC (UMR_S_1138 / U1138) - Centre de Recherche des Cordeliers
34 CIRI - Centre International de Recherche en Infectiologie
35 RAISE - Centre de référence des rhumatismes inflammatoires et maladies auto-immunes systémiques rares de l’enfant / National Referee Centre for Rheumatic and AutoImmune and Systemic Diseases in Children [Lyon]

Abstract

BACKGROUND: 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. METHODS: 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(th), 2021 and January 1(st), 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: ESPID Fellowship Award; Grandir-Fonds de Solidarité Pour L'enfance.
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hal-03696532 , version 1 (16-06-2022)

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Naim Ouldali, Haleh Bagheri, Francesco Salvo, Denise Antona, Antoine Pariente, et al.. Hyper inflammatory syndrome following COVID-19 mRNA vaccine in children: A national post-authorization pharmacovigilance study. The Lancet Regional Health - Europe, 2022, 17, ⟨10.1016/j.lanepe.2022.100393⟩. ⟨hal-03696532⟩
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