Myocarditis Adverse Events in VAERS By Chris Knight (Florida)
Dr Jessica Rose and Dr Peter McCullough have a new paper forthcoming examining myocarditis events, as reported in the US VAERS system for the recording of adverse vax effects. It was uncovered that myocarditis rates were significantly higher in youths between the ages of 13 to 23, with approximately 80 percent occurring in males. It only took eight weeks after the vax rollout for the 12-15-year-old age group, to produce 19 times the expected number of myocarditis cases in the vaccination volunteers relative to background myocarditis rates for this age group. Worse still, a 5-fold increase in myocarditis rate was observed after dose 2 as opposed to dose 1 in 15-year-old males. They conclude that these findings suggest a markedly higher risk for myocarditis after the Covid vax, than for other known vaccines.
“A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products Jessica Rose, PhD, MSc, BSc* and Peter A. McCullough.
https://jessica5b3.substack.com/p/a-report-on-myocarditis-adverse-events
“Abstract
Following the global rollout and administration of the Pfizer Inc./BioNTech BNT162b2 and Moderna mRNA-1273 vaccines on December 17, 2020, in the United States, and of the Janssen Ad26.COV2.S product on April 1st, 2021, in an unprecedented manner, hundreds of thousands of individuals have reported adverse events (AEs) using the Vaccine Adverse Events Reports System (VAERS). We used VAERS data to examine cardiac AEs, primarily myocarditis, reported following injection of the first or second dose of the COVID-19 injectable products. Myocarditis rates reported in VAERS were significantly higher in youths between the ages of 13 to 23 (p<0.0001) with ∼80% occurring in males. Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males. A total of 67% of all cases occurred with BNT162b2. Of the total myocarditis AE reports, 6 individuals died (1.1%) and of these, 2 were under 20 years of age - 1 was 13. These findings suggest a markedly higher risk for myocarditis subsequent to COVID-19 injectable product use than for other known vaccines, and this is well above known background rates for myocarditis. COVID-19 injectable products are novel and have a genetic, pathogenic mechanism of action causing uncontrolled expression of SARS-CoV-2 spike protein within human cells. When you combine this fact with the temporal relationship of AE occurrence and reporting, biological plausibility of cause and effect, and the fact that these data are internally and externally consistent with emerging sources of clinical data, it supports a conclusion that the COVID-19 biological products are deterministic for the myocarditis cases observed after injection.
Discussion
In the context of COVID-19, and according to Dr. Leslie Cooper, there are a significant number of patients who present clinically as healthy who are experiencing heart-related complications, including myocarditis. 72,17,18,19 There is a high risk of cardiac involvement both from COVID-19 infection and from COVID-19 injectable products and the risks of the latter must be further assessed and evaluated. Because of the spontaneous reporting of events to VAERS, we can assume that the cases reported thus far are not rare, but rather, just the tip of the iceberg. Again, under-reporting is a known and serious disadvantage of the VAERS system.28,29,30 The only way to understand how common myocarditis is after COVID-19 vaccination, is to perform a prospective cohort study where all vaccinated individuals undergo clinical assessment, ECG, and troponin measurement at regular intervals post-administration.
The fact that the VAERS reporting of myocarditis is 6X higher in 15-year-olds following dose 2 may be indicative of a cause-effect relationship. If we assume that following dose 1, a certain percentage of healthy young males who lack co-morbidities or co-factors experience cardiac-related AEs mild enough so as not to dissuade them from receiving dose 2 (ie: pallor, chest pain and shortness of breath, for example), then it is not difficult to imagine that they may have been experiencing symptoms of myocarditis. If a percentage of young males had experienced primary damage to the heart as a result of inflammation following dose 1, then dose 2 may have induced a much more noticeable clinical impact, or cardiac ‘insult’. In other words, these young males may receive a definitive diagnosis of myocarditis only following dose 2. What this implies, based on these assumptions, is that if there is a causal relationship then it might manifest with overlooked/unreported AEs following dose 1 and a diagnosis of myocarditis following dose 2. It is noteworthy that ‘Vaccine-induced myocarditis’ was in fact used as the descriptor by medical professionals as the reason for the myocarditis in the VAERS database.
During phase III clinical trials for the mRNA COVID-19 products, safety was assessed based on a maximum observation period of 6 months. This is not adequate to assess long-term safety outcomes as it is a requirement, even in an accelerated timeline setting, to spend up to 9 months in Phase III trials.8 The typical timeline is up to 10 years for safety and efficacy assessment.47,48 There are many examples of biological product recalls historically. In 2010, rotavirus vaccines licensed in the U.S were found to contain Porcine circovirus (PCV) type 1 and were subsequently suspended. In 2009, an increased risk of narcolepsy was found following vaccination with a monovalent H1N1 influenza vaccine that was used in several European countries during the H1N1 influenza pandemic. Between 2005 and 2008, a meningococcal vaccine was suspected to cause Guillain-Barré Syndrome (GBS). In 1998, a vaccine designed to prevent rotavirus gastroenteritis was associated with childhood intussusception after being vaccinated. Also in 1998, a hepatitis B vaccine product was linked to multiple sclerosis (MS).49 It is also vital to address that pregnant woman were in the exclusion criteria list for the Phase III trials (ref: NCT04368728) and thus it is unclear how a safety assessment can be made for pregnant women when the products were only tested for 6 months.50 In this context, it is worth reiterating that BNT162b2, mRNA-1273, and the Ad26.COV2.S products have not been approved or licensed by the U.S. Food and Drug Administration (FDA), having been authorized instead for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19), and was originally meant for use in individuals 16 years of age and older.32,33,34 mRNA platforms have never before been implemented for use in human subjects on a global scale in the context of viruses and it has recently been shown that the spike protein itself systemically traffics inducing damage within cells, at the cell surface, and through circulation with endothelial damage and thrombosis.44,45 It is unknown which cells and organs are seeded with mRNA, the cellular half-life of the products, duration of spike protein production, reverse transcription, future regulation, and ultimate disposal of mRNA technology.51,52 Safety is always a point of relevance with regards to new biological agents and given these new findings, it would be prudent to pay particular attention to the AEs being reported to the VAERS system in the context of these experimental products with known dangerous mechanisms of action. When evidence of harm appears, we need to follow the evidence and immediately take steps to mitigate risks.
Based on this study, the risk of suffering myocarditis subsequent to injection with the mRNA-based products is low with an average of 4 individuals suffering myocarditis per million fully injected. However, the Israeli Ministry of Health recently announced that approximately 1 in 4,500 men ages 16 to 24 who received BNT162b2 developed myocarditis.46 This rate is much higher than the rate estimated based on VAERS data and could reflect variation in reporting. Nonetheless, the risk is higher for the young with an average of 28 12-15-year-olds succumbing to myocarditis per million fully immunized. Discerning between ICU-related mild cardiac injury with SARS-CoV-2 respiratory infection and myocarditis in the context of COVID-19 and the injectable biologicals is important. In establishing background rates of myocarditis in the context of both COVID-19 and injection-associated cardiac injuries, it is vital to ensure that true myocarditis is ensuing for diagnostic purposes. This can be achieved by definitively quantifying the levels of markers for myocarditis such as troponin (I and T), EKG/echocardiograms, and detecting deviations in ST and T waves, PR and QT intervals and T wave inversion. Changes the overall area under the curve for cardiac troponin, reductions in left ventricular ejection fraction, and changes in tissue characterization by cardiac MRI can also be used as diagnostic quantifiers to aid in discerning between CIRM and ICU-related cardiac injuries. As a general rule, the ICU cardiac injury described in COVID-19 illness is subclinical and largely reflected by a minor elevation of cardiac troponin, whereas CIRM is characterized by a clinical syndrome often warranting hospitalization, dramatic ECG changes, and very large elevations of cardiac troponin that are sustained over time.53,54,55,56,57,58,87
It is vital to recall that children have a negligible risk for COVID-19 respiratory illness, and yet they are a high-risk group for myocarditis with vaccination. Newly-published evidence of Vaccine-Induced Autoimmune Myocarditis,58 demonstrates the risks of myocarditis associated with vaccination.87,88,89,92,93,94,95 Despite this, a recent CDC report (May 31, 2021) claimed no danger signal was detectable from the VAERS AE data in the context of myocarditis and as such, they continue to support administration of these products into children 12 years of age and older despite reports of myocarditis and pericarditis in youth in temporal proximity to dose administration.94
It possible that vaccine-induced myocarditis is amplified by prior infection and pathogenic priming. Higher uptake of genetic material in some younger individuals who have been previously recovered from COVID-19 and were vaccinated, may partially explain why some individuals suffer from CIRM and others do not. Nevertheless, the background rate for children aged 12-15 has been established outside of the COVID-19 context and the rates in the context of CIRM are 19 times higher than the expected value.
A recent study shows increased myocardial ACE-2 expression in individuals with ‘basic heart failure disease’ indicating an intrinsic susceptibility of the heart to SARS-CoV-2 infection and worse prognosis.55 Another study in Hypertension from 2008 claims that cardiac over-expression of ACE-2 exerts protective influence on the heart during myocardial infarction by preserving left ventricular wall motion and contractility, and by attenuating LV wall thinning.56 However, we postulate the pathogenesis of CIRM must be much different with isolated production of spike protein over a sustained period of time and expression of the cell surface of cardiomyocytes, which would be considerably different than virion replication. The implications are the ACE-2 expression probably plays a smaller role in vaccine-induced myocardial injury and it has been noted by the co-author that the latter is more highly-associated with maintained elevated troponin levels. [unpublished clinical findings]
Additional information may be gleaned from routine EKG readings and cardiac troponin measurement in volunteers post-injection. It is unknown if in-situ production or perfusion with blood carrying spike protein are the major mechanisms by which CIRM is initiated. Once, damaged, inflammation in the myocardium may last for weeks or months after the original insult is removed.55,58 The exact mechanisms of action for induction and progression of CIRM needs to be elucidated to ensure improved and safer products for the future.
The clinical implications of acute myocarditis in younger individuals as a result of uncontrolled production of the SARS-CoV-2 spike protein within cardiac myocytes and cardiac support cells is unknown. If myocarditis has developed after the first injection, then second administrations and boosters should be avoided. Sustained elevations of cardiac troponin, reduction in left and right ventricular function, large areas of inflammation or scar on imaging, and cardiac arrhythmias all portend a poor prognosis for the development of heart failure and cardiac death. Because the duration of action of genetic material coding for spike protein is unknown, follow-up with cardiology consultation is advised in all cases and repeat imaging and biomarkers is wise. Empiric treatment with renin-angiotensin system inhibitors and evidence-based beta-blockers is advised for those at risk for or with manifest left ventricular dysfunction.
Conclusions
These data are derived from a rushed, non-FDA-approved, ongoing investigational product roll-out, and our conclusions are thus limited by the information at hand. In addition to the 12-15-year-old age group data being very early, it is vital to acknowledge that these reports represent a fraction of the actual total. Thus, due to both the problems of under-reporting and the known lag in report processing, this analysis reveals a strong signal from the VAERS data that the risk of suffering CIRM – especially males is unacceptably high. Again, children are not a high-risk group for COVID-19 respiratory illness, and yet they are the high-risk group for CIRM.
Efficacy of these products needs to be assessed by immunological assays and long-term studies are required, while safety needs to be evaluated by rigorous clinical, laboratory and imaging assessments of severe reported adverse events such as CIRM. Autopsies should be done in cases of cardiovascular-related deaths temporally associated with COVID-19 injectables. It is reasonable to use the precautionary principle in this particular setting since an alarming number of reports are coming from young males between the ages of 12 and 15. Boys of these ages should be carefully monitored for warning signs of myocarditis which many may pass off such as pallor, chest pain, shortness of breath or lethargy, following dose 1 with the aim of seeking prompt evaluation and avoiding dose 2.
Effective multidrug therapy is available for rare case of serious COVID-19 respiratory illness in the forms of antivirals, immunomodulators, and anthrombotics.59,60,61,62,63,64,65,66,67,68,69,70,71,72 The combination of a low IFR in children indicating effective and robust immune responses73,74,75,76,77,78,79,80,81,82,83, and the ability to treat with medical therapy, should the need arise, bodes well for clinical outcomes in children69,70,71,72.
As part of any risk/benefit analysis which must be completed in the context of experimental products, the points herein must be considered before a decision can be made pertaining to agreeing to 2-dose injections of these experimental COVID-19 products, especially into children and by no means, should parental consent be waived under any circumstances to avoid children volunteering for injections with products that do not have proven safety or efficacy.
Future work may include on-site clinical observations of Troponin, BNP, galectin-3, ST2, IL-6 and D-dimer levels to corroborate temporal effects of onset of myocarditis following injections with particular COVID-19 products. Delineation between COVID-19 respiratory infection with mild ICU-related cardiac injury and true CIRM using these and other clinical diagnostic markers would be incredibly useful for clinicians and should become the standard for differential diagnosis of suspected CIRM. Correcting the inherent limitations of the VAERS dataset must be a priority as part of future studies. Incomplete VAERS dataset field entries describing prior COVID-19 infection and diagnostic tests such as cardiac MRIs in individuals diagnosed with myocarditis, for example, would make this particular study even more potent. However, despite these limitations, and the limitation of using the VAERS dataset for studies like this one, the usable sample sizes have good statistical power. Ultimately, it remains vital to share the results herein to allow true pharmacovigilance to take place.”
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