Features of inflammatory heart reactions following mRNA COVID-19 vaccination at a global level
| dc.rights.license | open | en_US |
| dc.contributor.author | CHOUCHANA, Laurent | |
| dc.contributor.author | BLET, Alice | |
| dc.contributor.author | AL-KHALAF, Mohammad | |
| dc.contributor.author | KAFIL, Tahir S. | |
| dc.contributor.author | NAIR, Girish | |
| dc.contributor.author | ROBBLEE, James | |
| dc.contributor.author | DRICI, Milou Daniel | |
| dc.contributor.author | VALNET-RABIER, Marie Blanche | |
| dc.contributor.author | MICALLEF, Joelle | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | SALVO, Francesco | |
| dc.contributor.author | TRELUYER, Jean Marc | |
| dc.contributor.author | LIU, Peter P. | |
| dc.date.accessioned | 2022-01-19T14:36:46Z | |
| dc.date.available | 2022-01-19T14:36:46Z | |
| dc.date.issued | 2021-12-03 | |
| dc.identifier.issn | 1532-6535 (Electronic) 0009-9236 (Linking) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/124437 | |
| dc.description.abstractEn | Myocarditis 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.iso | EN | en_US |
| dc.rights | Attribution-NonCommercial-NoDerivs 3.0 United States | * |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/us/ | * |
| dc.title.en | Features of inflammatory heart reactions following mRNA COVID-19 vaccination at a global level | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1002/cpt.2499 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 34860360 | en_US |
| bordeaux.journal | Clinical Pharmacology and Therapeutics | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.team | PharmacoEpi-Drugs | en_US |
| bordeaux.team | AHEAD_BPH | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| bordeaux.identifier.funderID | Canadian Institutes of Health Research | en_US |
| bordeaux.identifier.funderID | Heart and Stroke Foundation of Canada | en_US |
| bordeaux.identifier.funderID | Genome Canada | en_US |
| bordeaux.identifier.funderID | University of Ottawa | en_US |
| hal.identifier | hal-03534754 | |
| hal.version | 1 | |
| hal.date.transferred | 2022-01-19T14:36:51Z | |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_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 |
