| アブストラクト | AIMS: While some concerns about vaccination-related pericarditis and/or myocarditis have been raised, no published data are available on pericarditis and/or myocarditis with mRNA COVID-19 vaccines in the age group of adolescents, particularly 12-15 years. The objective of this study was to determine whether the risk of reporting pericarditis and/or myocarditis with mRNA COVID-19 vaccines varied according to dose of vaccination, age, sex, and type of pericarditis and/or myocarditis in adolescents between 12 and 17 years. METHODS AND RESULTS: We performed an observational study reviewing all reports of adolescents vaccinated with mRNA COVID-19 vaccines and recorded in VigiBase(R), the World Health Organization global database of individual case safety reports. We included all reports registered between 1 January 2021 and 14 September 2021. Reporting odds ratios (RORs) with their 95% confidence interval (CI) were calculated to estimate the risk of reporting pericarditis and/or myocarditis. Among 4942 reports with mRNA COVID-19 vaccines in adolescents, we identified 242 pericarditis and/or myocarditis. Compared with the first dose of mRNA COVID-19 vaccines, the second dose was associated with an increased risk of reporting pericarditis and/or myocarditis (ROR 4.95; 95% CI 3.14, 7.89). The risk of reporting pericarditis and/or myocarditis was 10 times higher in boys than in girls and no difference between the two types of vaccines could be demonstrated. CONCLUSION: This investigation including only adolescent data suggests for the first time that the second dose of mRNA COVID-19 vaccines increases the risk of reporting myocarditis/pericarditis compared with the first dose particularly in boys without significant difference between tozinameran and elasomeran. |
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| 投稿者 | Foltran, Deborah; Delmas, Clement; Flumian, Clara; De Paoli, Pierre; Salvo, Francesco; Gautier, Sophie; Drici, Milou-Daniel; Karsenty, Clement; Montastruc, Francois |
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| 組織名 | Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and;Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital (CHU), 37;Allees Jules Guesde, F-31000 Toulouse, France.;Team PEPSS (Pharmacologie En Population cohorteS et biobanqueS), Centre;d'Investigation Clinique 1436, Toulouse University Hospital, France.;Department of Cardiology, Faculty of Medicine, Toulouse University Hospital;(CHU), Toulouse, France.;INSERM U1219, Bordeaux Population Health, Team Pharmacoepidemiology, University;of Bordeaux, F-33000 Bordeaux, France.;Medical Pharmacology Unit, Public Health Division, Bordeaux University Hospital;(CHU), F-33000 Bordeaux, France.;Centre of Pharmacovigilance, Department of Clinical Pharmacology, Lille;University, Lille University Hospital, F-59045 Lille, France.;Department of Pharmacology and Pharmacovigilance, Pasteur Hospital Center of;Nice, Nice University Hospital, F-06001 Nice Cedex 01, France.;Pediatric Cardiology Unit, Children Hospital, CHU Toulouse, 330 Avenue de Grande;Bretagne TSA 70034, F-31059 Toulouse Cedex 9, France.;Institut Des Maladies Metaboliques et Cardiovasculaires, Universite de Toulouse,;INSERM U1048, I2MC, Toulouse, France. |
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