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

Naim Ouldali 1, 2, 3, 4 Haleh Bagheri 5 Francesco Salvo 6, 7 Denise Antona 8 Antoine Pariente 6 Claire Leblanc 1 Martine Tebacher 9 Joelle Micallef 10, 11 Corinne Levy 3, 12, 13 Robert Cohen 3, 12, 13 Etienne Javouhey 14, 15 Brigitte Bader-Meunier 16, 17, 18 Caroline Ovaert 19, 20 Sylvain Renolleau 16, 21 Veronique Hentgen 22, 23 Isabelle Kone-Paut 23, 24, 25 Nina Deschamps 26 Loic de Pontual 27 Xavier Iriart 7, 28, 29 Christelle Gras-Le Guen 30, 31, 32 Francois Angoulvant 1, 33 Alexandre Belot 14, 34, 35 
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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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, Elsevier, 2022, 17, ⟨10.1016/j.lanepe.2022.100393⟩. ⟨hal-03696532⟩

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