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Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective.
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.
Authors
- Alami, Abdallah, Alami A, School of Mathematics and Statistics, Carleton University, Ottawa, ON K1S 5B6, Canada.; McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, ON K1N 6N5, Canada.
- Villeneuve, Paul J, Villeneuve PJ, Department of Neuroscience, Faculty of Science, Carleton University, Ottawa, ON K1S 5B6, Canada.
- Farrell, Patrick J, Farrell PJ, School of Mathematics and Statistics, Carleton University, Ottawa, ON K1S 5B6, Canada.
- Mattison, Donald, Mattison D, School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON K1G 5Z3, Canada.; Risk Sciences International, Ottawa, ON K1P 5J6, Canada.; Arnold School of Public Health, University of South Carolina, Columbia, SC 29208, USA.
- Farhat, Nawal, Farhat N, School of Mathematics and Statistics, Carleton University, Ottawa, ON K1S 5B6, Canada.
- Haddad, Nisrine, Haddad N, School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON K1G 5Z3, Canada.
- Wilson, Kumanan, Wilson K, Department of Medicine, University of Ottawa, Ottawa, ON K1H 8M5, Canada.; Bruyère Research Institute, Ottawa, ON K1R 6M1, Canada.; Ottawa Hospital Research Institute, Ottawa, ON K1Y 4E9, Canada.
- Gravel, Christopher A, Gravel CA, School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON K1G 5Z3, Canada.; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC H3A 1Y7, Canada.; Department of Mathematics and Statistics, University of Ottawa, Ottawa, ON K1N 6N5, Canada.
- Crispo, James A G, Crispo JAG, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC V6T 1Z3, Canada.; Division of Human Sciences, NOSM University, Sudbury, ON P3E2C6, Canada.
- Perez-Lloret, Santiago, Perez-Lloret S, Consejo Nacional de Investigaciones CientÃficas y Técnicas (CONICET), Buenos Aires C1033AAJ, Argentina.; Observatorio de Salud Pública, Pontificia Universidad Católica Argentina, Buenos Aires C1107AAZ, Argentina.; Department of Physiology, Faculty of Medicine, University of Buenos Aires, Buenos Aires C1121ABG, Argentina.
- Krewski, Daniel, Krewski D, McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, ON K1N 6N5, Canada.; School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON K1G 5Z3, Canada.; Risk Sciences International, Ottawa, ON K1P 5J6, Canada.
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.
