A Pharmacoepidemiological Approach For Evaluating The Risk Of Myocarditis And Pericarditis Following Mrna COVID-19 Vaccination

Abstract

ObjectivesThis thesis evaluates the risk of myocarditis and pericarditis (myo/pericarditis) post-mRNA COVID-19 vaccination. MethodsThree complementary approaches were employed: disproportionality analysis using Vaccine Adverse Event Reporting System (VAERS) for early safety signals, analysis of observed-to-expected reporting rates, and a systematic review and meta-analysis comparing the rate of myo/pericarditis among vaccinated relative to unvaccinated individuals. ResultsAnalysis of VAERS and observed-to-expected reporting rates identified a signal for myo/pericarditis following mRNA COVID-19 vaccination, predominantly in young males post second doses. The meta-analysis further corroborated the findings, indicating a higher risk in those who received mRNA COVID-19 vaccinations compared to unvaccinated individuals in the absence of COVID-19 infection. ConclusionThe multi-faceted approach adopted in this study indicates a potential risk of myo/pericarditis following mRNA COVID-19 vaccination. However, further research is needed to explore co-factors, genetic predisposition, and risks in special populations, to inform public health decisions and shape vaccine recommendations.