New Extensive Independent Study: mRNA Vaccines and Myocarditis.

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Myocarditis after SARS-CoV-2 infection and COVID-19 vaccination: Epidemiology, outcomes, and new perspectives

ABSTRACT

Myocarditis, typically manifesting as myopericarditis, is among the serious cardiac consequences observed over the course of the COVID-19 pandemic. We performed a comprehensive, evidence-based literature synthesis of  findings from clinical trial data reanalysis, post-marketing surveillance, large observational studies, and other diverse research sources that help shed light on the phenomenon of myocarditis post SARS-CoV-2 infection versus COVID-19 vaccine-induced myocarditis. Our conclusions refute several claims previously made by public health agencies and professional associations, namely the following: (1) the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Omicron infections have caused more cases of myocarditis than the COVID-19 mRNA immunizations; (2) mRNA vaccine-induced myocarditis is typically mild, transient, and rare, with no long-term sequelae; and (3) the risk-benefit calculus favors continued use of these products despite evidence of more iatrogenic cases. We address each of these misconceptions by applying a combination of epidemiological, clinical, and immunological perspectives. We urge governments to remove the COVID-19 mRNA products from the market due to the well-documented risk of myocardial damage, a risk that is strongest for younger males (<40 years old).

CONCLUSIONS

Myocarditis remains one of the most significant cardiac adverse events linked to the COVID-19 mRNA vaccines manufactured by Pfizer and Moderna. This review critically evaluated the relationship between mRNA vaccines and myocarditis using evidence from reanalysis of clinical trials, post marketing data, prospective cardiac-monitoring studies, and large observational studies. Despite consistent safety signals showing a relatively high risk of myocarditis and its sequelae in younger age groups, public health authorities have defended the continued use of these products with claims that myocarditis from SARS-CoV-2 infections, including Omicron, is more frequent; that vaccine-related myocarditis is rare, mild, and transient (without long term sequelae); and that the benefits outweigh the risks. However, our critique, grounded in epidemiological, clinical, and immunological evidence, challenges these assertions. e combination of low risk of severe COVID-19 and a higher likelihood of mRNA vaccine-related myocarditis in younger people makes it difficult to rationalize a policy of ongoing mRNA vaccines in this population. The theoretical absolute benefit of COVID-19 mRNA vaccination is largely contingent on an individual’s baseline risk of severe COVID-19 disease, prior natural immunity, current SARS-CoV-2 and access to early ambulatory treatment protocols. For healthy individuals under the age of 20, 30, or 40, the upper bound of absolute benefits has consistently been negligible across all strains, often approaching zero. Furthermore, no robust studies to date have reliably established a benefit of the COVID-19 vaccination in infants, children and young adults. Even relatively rare safety signals (on a population-wide basis) can substantially alter the overall risk-benefit analysis in younger populations. The analyses by Krug et al., and Bourdon et al., both substantiate an unfavorable risk-benefit calculus. Specifically, for young males, the risk associated with COVID-19 mRNA vaccine-related myocarditis following the second dose exceeds the potential upper-bound reduction in severe COVID-19 outcomes. This underscores the critical need for age- and risk-stratified evaluations to better inform public health policy and to ensure that the harms do not consistently outweigh the theoretical benefits. Given the substantial evidence presented here concerning cardiotoxicity and serious cardiac events in younger generations, we strongly recommend the immediate withdrawal of COVID-19 mRNA products from the market.

PDF link:

https://cardiovascular-research-and-innovation.reseaprojournals.com/archive_files/Myocarditis after SARS-CoV-2 infection and COVID-19 vaccination Epidemiology, outcomes, and new perspectives.pdf

 

 

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