BNT162b2 Vaccine‐Associated Myo/Pericarditis in Adolescents: A Stratified Risk‐Benefit Analysis
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Abstract
ABSTRACT Objectives Establishing the rate of post-vaccination cardiac myocarditis in the 12-15 and 16-17-year-old population in the context of their COVID-19 hospitalization risk is critical for developing a vaccination recommendation framework that balances harms with benefits for this patient demographic. Design, Setting and Participants Using the Vaccine Adverse Event Reporting System (VAERS), this retrospective epidemiological assessment reviewed reports filed between January 1, 2021, and June 18, 2021, among adolescents ages 12-17 who received mRNA vaccination against COVID-19. Symptom search criteria included the words chest pain, myocarditis, pericarditis and myopericarditis to identify children with evidence of cardiac injury. The word troponin was a required element in the laboratory findings. Inclusion criteria were aligned with the CDC working case definition for probable myocarditis. Stratified cardiac adverse event (CAE) rates were reported for age, sex and vaccination dose number. A harm-benefit analysis was conducted using existing literature on COVID-19-related hospitalization risks in this demographic. Main outcome measures 1) Stratified rates of mRNA vaccine-related myocarditis in adolescents age 12-15 and 16-17; and 2) harm-benefit analysis of vaccine-related CAEs in relation to COVID-19 hospitalization risk. Results A total of 253 CAEs were identified. Rates per million following dose 2 among males were 162.2 (ages 12-15) and 93.0 (ages 16-17); among females, rates were 13.0 and 12.5 per million, respectively. For boys 12-15 without medical comorbidities receiving their second mRNA vaccination dose, the rate of CAE is 2.6 to 4.3 times higher than their 120-day COVID-19 hospitalization risk even at times of peak incidence such as during the delta wave (7-day hospitalizations 2.1/100k population). For boys 16-17 without medical comorbidities, the rate of CAE is 1.5 to 2.5 times higher at times of high weekly COVID-19 hospitalization. Conclusions Post-vaccination CAE rate was highest in young boys aged 12-15 following dose two. For boys 12-17 without medical comorbidities, the likelihood of post vaccination dose two CAE is 162.2 and 93.0/million respectively. This incidence exceeds their expected 120-day COVID-19 hospitalization rate at both moderate and high COVID-19 hospitalization incidence. Further research into the severity and long-term sequelae of post-vaccination CAE is warranted. Quantification of the benefits of the second vaccination dose and vaccination in addition to natural immunity in this demographic may be indicated to minimize harm.
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Spontaneous-reporting systems have registered serious adverse reactions including anaphylaxis (all COVID-19 vaccines), thrombocytopenia syndrome among premenopausal females (Janssen vaccine), and myocarditis and pericarditis among younger males (Pfizer and Moderna vaccines).
“reactions including anaphylaxis (all COVID-19 vaccines), thrombocytopenia syndrome among premenopausal females (Janssen vaccine), and myocarditis and pericarditis among younger males (Pfizer and Moderna vaccines). [19,20].”
From Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults (2022) · cites this paper as [20]
The Methods and Results (page not provided) describe VAERS reports of myocarditis and pericarditis in adolescents, predominantly males who received Pfizer-BioNTech vaccine. The Principal findings (page not provided) also discuss reported myocarditis rates after Moderna vaccination. The copy does not support the claims about anaphylaxis across all COVID-19 vaccines or thrombocytopenia syndrome among premenopausal Janssen recipients. (LLM, conf=0.88)
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The question: Types of research questions and how to develop them
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- Authors
- Krug, A., Stevenson, J., & Høeg, T. B.
- Affiliations
- Artemis Biomedical Communications, LLC Virginia Beach Virginia USA
- Sierra Nevada Memorial Hospital Foundation (US)
- University of California, Davis (US)
- Corresponding author
- Høeg, Tracy Beth
- Venue
- European Journal of Clinical Investigation
- Publisher
- Wiley
- Published
- 2022-03-04
- Volume
- 52
- Issue
- 5
- Pages
- e13759-e13759
- ISSN
- 0014-2972 (ISSN-L)
- 1365-2362
- PMC
- PMC9111575
- OpenAlex
- W4213140249
- Cited by
- 69
- References
- 50
- Citations by year
- 2025: 5 · 2024: 13 · 2023: 20 · 2022: 23 · 2021: 8
- FWCI
- 7.44
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Licence
- Locations
- European Journal of Clinical Investigation (publishedVersion)
- medRxiv (acceptedVersion, cc-by-nd)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Viral Infections and Immunology Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- BNT162b2, COVID-19 mRNA vaccine, adolescents, risk-benefit assessment, sex differences, prior SARS-CoV-2 infection, comorbidities, COVID-19 hospitalization, Omicron variant, Delta variant, VAERS
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, BNT162 Vaccine, Adolescent, Child, Female, Humans, Male, Pericarditis, RNA, Messenger
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