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박재유Jaeyu Park

경희대학교

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J. Med. Virol., Jun 2024, 96 (6) | https://doi.org/10.1002/jmv.29693 Global estimates on the reports of vaccine-associated myocarditis and pericarditis from 1969 to 2023: Findings with critical reanalysis from the WHO pharmacovigilance database

Sooji Lee ^1,2, Hyesu Jo^2,3, Hyeri Lee ^2,3, Hayeon Lee ^2,4, Jinseok Lee ⁴, Hyeon Jin Kim ^2,3, Jiseung Kang ^5,6, Louis Jacob ^7,8,9, Lee Smith ¹⁰, Masoud Rahmati ^11,12,13, Guillermo F López Sánchez ¹⁴, Elena Dragioti ^15,16, Hongki Jeon ¹⁷, Jin-Man Cho ¹⁷, Yujin Choi ^2,18, Jaeyu Park^2,3, Selin Woo ², Dong Keon Yon^1,2,3,19

¹Department of Medicine, Kyung Hee University College of Medicine, Seoul, South Korea.

²Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.

³Department of Regulatory Science, Kyung Hee University, Seoul, South Korea.

⁴Department of Biomedical Engineering, Kyung Hee University, Yongin, South Korea.

⁵Division of Sleep Medicine, Harvard Medical School, Boston, Massachusetts, USA.

⁶Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

⁷Research and Development Unit, Parc Sanitari Sant Joan de Déu, CIBERSAM, ISCIII, Barcelona, Spain.

⁸Department of Physical Medicine and Rehabilitation, Lariboisière-Fernand Widal Hospital, AP-HP, Université Paris Cité, Paris, France.

⁹Epidemiology of Ageing and Neurodegenerative Diseases (EpiAgeing), Inserm U1153, Université Paris Cité, Paris, France.

¹⁰Centre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK.

¹¹CEReSS-Health Service Research and Quality of Life Center, Assistance Publique Des Hôpitaux de Marseille, Aix-Marseille University, Marseille, France.

¹²Department of Physical Education and Sport Sciences, Faculty of Literature and Human Sciences, Lorestan University, Khoramabad, Iran.

¹³Department of Physical Education and Sport Sciences, Faculty of Literature and Humanities, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.

¹⁴Division of Preventive Medicine and Public Health, Department of Public Health Sciences, School of Medicine, University of Murcia, Murcia, Spain.

¹⁵Pain and Rehabilitation Centre, and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.

¹⁶Research Laboratory Psychology of Patients, Families, and Health Professionals, Department of Nursing, School of Health Sciences, University of Ioannina, Ioannina, Greece.

¹⁷Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.

¹⁸Department of Korean Medicine, Kyung Hee University College of Korean Medicine, Seoul, South Korea.

¹⁹Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.

Sooji Lee, Hyesu Jo, and Hayeon Lee contributed equally to this study as co-first authors.

Correspondence : Jaeyu Park, Selin Woo, and Dong Keon Yon

Abstract

Due to the limitation of previous studies examining adverse reports of myocarditis and pericarditis associated with vaccines other than the COVID-19 vaccine, there are challenges in establishing a comprehensive understanding of vaccine safety on a global scale. Hence, the objective of this study was to examine the worldwide burden of vaccine-associated pericarditis and myocarditis and the vaccines associated with these indications. This study utilized the World Health Organization international pharmacovigilance database, from which records of vaccine-associated pericarditis and myocarditis between 1969 and 2023 were extracted (over 130 million reports). We calculated global reporting counts, reported odds ratios (RORs), and information components (ICs) to discern the association between 19 vaccines and the occurrence of pericarditis and myocarditis across 156 countries and territories. We identified 49 096 reports (male, n = 30 013) of vaccine-associated pericarditis and myocarditis among 73 590 reports of all-cause pericarditis and myocarditis. There has been a significant increase in reports of vaccine-related cardiac adverse events over time, with a noteworthy surge observed after 2020, attributed to cases of pericarditis associated with COVID-19 mRNA vaccines. Smallpox vaccines were associated with most pericarditis and myocarditis reports (ROR: 73.68 [95% CI, 67.79-80.10]; IC [IC _0.25]: 6.05 [5.91]), followed by COVID-19 mRNA vaccine (37.77 [37.00-38.56]; 3.07 [3.05]), anthrax vaccine (25.54 [22.37-29.16]; 4.58 [4.35]), typhoid vaccine (6.17 [5.16-7.38]; 2.59 [2.29]), encephalitis vaccine (2.00 [1.48-2.71]; 0.99 [0.47]), influenza vaccine (1.87 [1.71-2.04]; 0.90 [0.75]), and Ad5-vectored COVID-19 vaccine (1.40 [1.34-1.46]; 0.46 [0.39]). Concerning age and sex-specific risks, reports of vaccine-associated pericarditis and myocarditis were more prevalent among males and in older age groups. The age group between 12 and 17 years exhibited significant sex disproportion. Most of these adverse events had a short time to onset (median time: 1 day) and fatality rate was 0.44%. Our analysis of global data revealed an increase in pericarditis and myocarditis reports associated with vaccines, particularly live vaccines like smallpox and anthrax, notably in young males. While these adverse events are generally rare and mild, caution is warranted, especially for healthcare workers, due to potential myocardial injury-related in-hospital mortality. Further study with validated reporting is crucial to enhance accuracy in evaluating the correlation between vaccines and cardiac conditions for preventive measures.

논문정보

형식Research article
게재일2024년 06월 (BRIC 등록일 2024-06-12)
연구진국내(교신)+국외 연구진
분야 바이오·의료융합 > 바이오·의료융합 기타

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