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

dc.rights.licenseopenen_US
dc.contributor.authorOULDALI, Naim
dc.contributor.authorBAGHERI, Haleh
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSALVO, Francesco
dc.contributor.authorANTONA, Denise
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorPARIENTE, Antoine
dc.contributor.authorLEBLANC, Claire
dc.contributor.authorTEBACHER, Martine
dc.contributor.authorMICALLEF, Joelle
dc.contributor.authorLEVY, Corinne
dc.contributor.authorCOHEN, Robert
dc.contributor.authorJAVOUHEY, Etienne
dc.contributor.authorBADER-MEUNIER, Brigitte
dc.contributor.authorOVAERT, Caroline
dc.contributor.authorRENOLLEAU, Sylvain
dc.contributor.authorHENTGEN, Veronique
dc.contributor.authorKONE-PAUT, Isabelle
dc.contributor.authorDESCHAMPS, Nina
dc.contributor.authorDE PONTUAL, Loic
dc.contributor.authorIRIART, Xavier
dc.contributor.authorGRAS-LE GUEN, Christelle
dc.contributor.authorANGOULVANT, Francois
dc.contributor.authorBELOT, Alexandre
dc.date.accessioned2022-06-14T13:50:20Z
dc.date.available2022-06-14T13:50:20Z
dc.date.issued2022-06
dc.identifier.issn2666-7762 (Electronic) 2666-7762 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/140210
dc.description.abstractEnBACKGROUND: 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.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enCOVID-19 mRNA vaccine
dc.subject.enBNT162b2
dc.subject.enMultisystem inflammatory syndrome in children
dc.subject.enHyper-inflammatory syndrome
dc.subject.enChild
dc.subject.enSARS-COV-2
dc.title.enHyper inflammatory syndrome following COVID-19 mRNA vaccine in children: A national post-authorization pharmacovigilance study
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.lanepe.2022.100393en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed35505833en_US
bordeaux.journalThe Lancet Regional Health - Europeen_US
bordeaux.volume17en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamAHEAD_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDEuropean Society for Paediatric Infectious Diseasesen_US
hal.identifierhal-03696532
hal.version1
hal.date.transferred2022-06-16T07:27:57Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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