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Features of inflammatory heart reactions following mRNA COVID-19 vaccination at a global level

dc.rights.licenseopenen_US
dc.contributor.authorCHOUCHANA, Laurent
dc.contributor.authorBLET, Alice
dc.contributor.authorAL-KHALAF, Mohammad
dc.contributor.authorKAFIL, Tahir S.
dc.contributor.authorNAIR, Girish
dc.contributor.authorROBBLEE, James
dc.contributor.authorDRICI, Milou Daniel
dc.contributor.authorVALNET-RABIER, Marie Blanche
dc.contributor.authorMICALLEF, Joelle
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSALVO, Francesco
dc.contributor.authorTRELUYER, Jean Marc
dc.contributor.authorLIU, Peter P.
dc.date.accessioned2022-01-19T14:36:46Z
dc.date.available2022-01-19T14:36:46Z
dc.date.issued2021-12-03
dc.identifier.issn1532-6535 (Electronic) 0009-9236 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/124437
dc.description.abstractEnMyocarditis and pericarditis may constitute adverse reactions of mRNA COVID-19 vaccines. This study aimed to document these reactions and to assess the association with patient sex and age. This is as an observational retrospective study using a case-non-case design (also called disproportionality study) on inflammatory heart reactions reported with mRNA COVID-19 vaccines within the WHO global safety database (VigiBase), up to June 30(th) 2021. Results are expressed using reporting odds-ratios (ROR) and their 95% confidence interval (95%CI). Of 716,576 reports related to mRNA COVID-19 vaccines, 2277 were cases of inflammatory heart reactions, including 1241 (55%) myocarditis and 851 (37%) pericarditis. The main age group was 18-29 years (704, 31%), and mostly males (1555, 68%). Pericarditis onset was delayed compared to myocarditis with a median time to onset of 8 [3-21] vs. 3 [2-6] days, respectively (p=0.001). Regarding myocarditis, an important disproportionate reporting was observed in adolescents (ROR, 22.3 [19.2-25.9]) and in 18-29 years old (ROR, 6.6 [5.9-7.5]) compared to older patients, as well as in males (ROR, 9.4 [8.3-10.6]). Reporting rate of myocarditis was increased in young adults and adolescents. Inflammatory heart reactions may rarely occur shortly following mRNA COVID-19 vaccination. Although an important disproportionate reporting of myocarditis was observed among adolescents and young adults, particularly in males, reporting rates support a very rare risk, that does not seem to compromise the largely positive benefit-risk balance of these vaccines. Furthermore, this study confirmed the value of disproportionality analyses for estimation of relative risks among subgroups of patients.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.title.enFeatures of inflammatory heart reactions following mRNA COVID-19 vaccination at a global level
dc.typeArticle de revueen_US
dc.identifier.doi10.1002/cpt.2499en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34860360en_US
bordeaux.journalClinical Pharmacology and Therapeuticsen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.teamAHEAD_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDCanadian Institutes of Health Researchen_US
bordeaux.identifier.funderIDHeart and Stroke Foundation of Canadaen_US
bordeaux.identifier.funderIDGenome Canadaen_US
bordeaux.identifier.funderIDUniversity of Ottawaen_US
hal.identifierhal-03534754
hal.version1
hal.date.transferred2022-01-19T14:36:51Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Clinical%20Pharmacology%20and%20Therapeutics&rft.date=2021-12-03&rft.eissn=1532-6535%20(Electronic)%200009-9236%20(Linking)&rft.issn=1532-6535%20(Electronic)%200009-9236%20(Linking)&rft.au=CHOUCHANA,%20Laurent&BLET,%20Alice&AL-KHALAF,%20Mohammad&KAFIL,%20Tahir%20S.&NAIR,%20Girish&rft.genre=article


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