Myocarditis and pericarditis post-mRNA covid-19 vaccination: insights from a pharmacovigilance perspective

• Autores: Alami, Abdallah; Villeneuve, Paul J.; Farrell, Patrick J.; Mattison, Donald; Farhat, Nawal; Haddad, Nisrine; Wilson, Kumanan; Gravel, Christopher A.; Crispo, James A. G.; Pérez Lloret, Santiago; Krewski, Daniel
• Año de publicación: 2023
• Idioma: inglés
• Tipo de recurso: artículo
• Fuente: Journal of Clinical Medicine. Vol.12, No.15, 4971, 2023
• Materia: MIOCARDITIS; PERICARDITIS; FARMACOVIGILANCIA; COVID-19; VACUNACION
• Institución: Pontificia Universidad Católica Argentina

Fil: Alami, Abdallah. Carleton University. School of Mathematics and Statistics; Canadá
Fil: Alami, Abdallah. University of Ottawa. McLaughlin Centre for Population Health Risk Assessment; Canadá
Fil: Villeneuve, Paul J. Carleton University. Faculty of Science. Department of Neuroscience; Canadá
Fil: Farrell, Patrick J. Carleton University. School of Mathematics and Statistics; Canadá
Fil: Mattison, Donald. University of Ottawa. School of Epidemiology and Public Health; Canadá
Fil: Mattison, Donald. Risk Sciences International; Canadá
Fil: Mattison, Donald. University of South Carolina. Arnold School of Public Health; Estados Unidos
Fil: Farhat, Nawal. Carleton University. School of Mathematics and Statistics; Canadá
Fil: Haddad, Nisrine. University of Ottawa. Public Health; Canadá
Fil: Haddad, Nisrine. University of Ottawa. School of Epidemiology; Canadá
Fil: Wilson, Kumanan. University of Ottawa. Department of Medicine; Canadá
Fil: Wilson, Kumanan. Bruyère Research Institute; Canadá
Fil: Wilson, Kumanan. Ottawa Hospital Research Institute; Canadá
Fil: Gravel, Christopher A. University of Ottawa. Public Health; Canadá
Fil: Gravel, Christopher A. University of Ottawa. School of Epidemiology; Canadá
Fil: Gravel, Christopher A. University of Ottawa. Department of Mathematics and Statistics; Canadá
Fil: Gravel, Christopher A. McGill University. Biostatistics and Occupational Health. Department of Epidemiology;Canadá
Fil: Crispo, James A. G. University of British Columbia.Faculty of Pharmaceutical Sciences; Canadá
Fil: Crispo, James A. G. University of Northern Ontario School of Medicine. Division of Human Sciences; Canadá
Fil: Pérez Lloret, Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Pérez Lloret, Santiago. Pontificia Universidad Católica Argentina. Observatorio de Salud Pública; Argentina
Fil: Pérez Lloret, Santiago. Universidad de Buenos Aires. Facultad de Medicina. Departamento de Fisiología; Argentina
Fil: Krewski, Daniel. University of Ottawa. McLaughlin Centre for Population Health Risk Assessment; Canadá
Fil: Krewski, Daniel. University of Ottawa. School of Epidemiology and Public Health; Canadá
Fil: Krewski, Daniel. Risk Sciences International; Canadá
Abstract: Concerns remain regarding the rare cardiovascular adverse events, myocarditis and pericarditis (myo/pericarditis), particularly in younger individuals following mRNA COVID-19 vaccination. Our study aimed to comprehensively assess potential safety signals related to these cardiac events following the primary and booster doses, with a specific focus on younger populations, including children as young as 6 months of age. Using the Vaccine Adverse Events Reporting System (VAERS), the United States national passive surveillance system, we conducted a retrospective pharmacovigilance study analyzing spontaneous reports of myo/pericarditis. We employed both frequentist and Bayesian methods and conducted subgroup analyses by age, sex, and vaccine dose. We observed a higher reporting rate of myo/pericarditis following the primary vaccine series, particularly in males and mainly after the second dose. However, booster doses demonstrated a lower number of reported cases, with no significant signals detected after the fourth or fifth doses. In children and young adults, we observed notable age and sex differences in the reporting of myo/pericarditis cases. Males in the 12–17 and 18–24-year-old age groups had the highest number of cases, with significant signals for both males and females after the second dose. We also identified an increased reporting for a spectrum of cardiovascular symptoms such as chest pain and dyspnea, which increased with age, and were reported more frequently than myo/pericarditis. The present study identified signals of myo/pericarditis and related cardiovascular symptoms after mRNA COVID-19 vaccination, especially among children and adolescents. These findings underline the importance for continued vaccine surveillance and the need for further studies to confirm these results and to determine their clinical implications in public health decision-making, especially for younger populations.