Another censored study, but luckily, as Mathew Crawford put it, “The Wayback Machine seems to have caught a glimpse . . .”

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[Norm’s note: merely because I wanted to get this posted before too long, the reference section is a mess. When I make the time, I’ll clean it up. On the other hand, I’m sure a careful reader can navigate his way through that tangle. I’m on my way out the door. But as soon as I can, I’ll get to this.]

Source: The Wayback Machine

Hat tip: Mathew Crawford

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 1, Peter A. McCullough MD, MPH 1

https://doi.org/10.1016/j.cpcardiol.2021.101011

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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.

Keywords

SARS-CoV-2; COVID-19; myocarditis; VAERS; adverse events (AEs); COVID-19-Injection-Related Myocarditis (CIRM)

Background

Myocarditis is inflammation of the myocardium or ‘musculature’ of the heart. [1,2,3,4] The myocardium is made up of many cell types however the greatest mass of tissue is accounted for by cardiomyocytes. [4,5,6] Cardiomyocytes are the principal contractile cells and are supported by specialized conduction and stromal cell types. [4,5,6,7,8] Both systole and diastole are active processes that expend energetic resources of cardiomyocytes which are organized into myofibrils. [8,9,10] Myocarditis can manifest as sudden death, chest pain or heart failure. The symptoms of heart failure from myocarditis include effort intolerance, dyspnea, fatigue, and ankle swelling. [1,2,3,4,6,11,12,13] The cause is an inflammation of the heart muscle, often following a viral infection, but not exclusively so. The damaged muscle is prone to lethal cardiac arrythmias as well as having the potential to develop both right and left ventricular dysfunction (cardiomyopathy). [3,4,12,13]Myocarditis is a major risk for cardiac death among the young. [11] The high-risk age population for myocarditis is from puberty through early 30s, and it is the third leading cause of sudden cardiac death in children and young adults. 1 per 100,000 children per year are affected by myocarditis and it has been reported that 0.05% of all pediatric hospitalizations are for myocarditis. Between 0.5 and 3.5% of heart failure hospitalizations are due to myocarditis. Most cases of myocarditis are identified in young adults with males affected more often than females. [12,13,14,15,16]In the context of COVID-19 respiratory illness, there are a significant number of patients who are otherwise healthy experiencing heart-related complications, including myocarditis, but the majority of clinical reports and diagnoses claim cardiac injury based on ICU-related-related injury to the heart. [17,18,19,20,21,22,23,24,25] This is relevant in terms of contextualizing the potential risk of myocarditis from the COVID-19 products against COVID-19 itself and establishing a background rate of myocarditis in specific contexts. Cardiac injuries associated with COVID-19 respiratory illness reveal a set of parameters based on a combination of measurements of troponin levels, electrocardiogram (ECG/EKG), echocardiogram readings, cardiac magnetic resonance imaging (MRI) and clinical symptoms that are different from the clinical picture of vaccine-induced myocarditis. COVID-19-Injection-Related Myocarditis (CIRM) can be defined as the onset of clinical myocarditis that is temporally associated with COVID-19 mRNA or adenoviral DNA vaccine administration and in the absence of another known cause. CIRM presents with clinical symptoms (chest pain, effort intolerance) combined with excessively elevated troponin levels, EKG changes (diffuse ST segment elevation) and in some cases left and right ventricular dysfunction on echocardiography. In cases where the echocardiogram is unrevealing, cardiac MRI can detect changes in tissue characterization consistent with myocardial inflammation. [22,23,24,25,26,27]The Vaccine Adverse Event Reporting System (VAERS) was created and implemented in 1990 by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) to receive reports about adverse events that may be associated with vaccines. [28] The primary purpose for maintaining the database is to serve as an early warning or signaling system for adverse events not detected during pre-market testing. In addition, the National Childhood Vaccine Injury Act of 1986 (NCVIA) requires health care providers and vaccine manufacturers to report to the DHHS specific adverse events following the administration of those vaccines outlined in the Act.1 Under-reporting is a known and serious disadvantage of the VAERS system. [28,29,30]An Adverse Event (AE) is defined as any untoward or unfavorable medical occurrence in a human study participant, including any abnormal physical exam or laboratory finding, symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research. A serious or severe adverse event (SAE) is defined as any adverse event that results in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires, or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects or is another condition which investigators judge to represent significant hazards. [28,30,31] These classifications are based on the Code of Federal Regulations. The VAERS handbook states that approximately 15% of reported AEs are classified as severe. [28] Myocarditis qualifies as an SAE as it is often associated with hospitalization.The BNT162b2, mRNA-1273, 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) for use in individuals 16 years of age and older.2[32,33,34] Ultimately, the roll-out of COVID-19 injectable biologicals are actively being monitored, but all of the risks are not yet known. [16,17,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46]

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Aside

On account of a security conern . . .

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Apologies for taking the site down, but something came up that struck me as possibly concerning, and it may yet be an issue. Consequently, I preemptively obliterated the site, and will slowly recover what I can in terms of posts over the coming weeks. It will take some time, however, since I’ll be away most days over the next month or so. I don’t think it was anything malicious but something that I myself may have done inadvertently. I hope not to have inconvenienced too may people in terms of links and references. On the other hand, if the issue crops up again, I may have to scrap this site entirely and start over again. We shall see.

Aye!

–N

Why are we vaccinating children against COVID-19? — Ronald N. Kostoff et al. | ScienceDirect

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Source: ScienceDirect

https://doi.org/10.1016/j.toxrep.2021.08.010

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Why are we vaccinating children against COVID-19?

Ronald N.Kostoff, DanielaCalina, DarjaKanduc, Michael B.Briggs, PanayiotisVlachoyiannopoulos, Andrey A.Svistunov, AristidisTsatsakis

Highlights

Bulk of COVID-19 per capita deaths occur in elderly with high comorbidities.
Per capita COVID-19 deaths are negligible in children.
Clinical trials for these inoculations were very short-term.
Clinical trials did not address long-term effects most relevant to children.
High post-inoculation deaths reported in VAERS (very short-term).

Abstract

This article examines issues related to COVID-19 inoculations for children. The bulk of the official COVID-19-attributed deaths per capita occur in the elderly with high comorbidities, and the COVID-19 attributed deaths per capita are negligible in children. The bulk of the normalized post-inoculation deaths also occur in the elderly with high comorbidities, while the normalized post-inoculation deaths are small, but not negligible, in children. Clinical trials for these inoculations were very short-term (a few months), had samples not representative of the total population, and for adolescents/children, had poor predictive power because of their small size. Further, the clinical trials did not address changes in biomarkers that could serve as early warning indicators of elevated predisposition to serious diseases. Most importantly, the clinical trials did not address long-term effects that, if serious, would be borne by children/adolescents for potentially decades.

A novel best-case scenario cost-benefit analysis showed very conservatively that there are five times the number of deaths attributable to each inoculation vs those attributable to COVID-19 in the most vulnerable 65+ demographic. The risk of death from COVID-19 decreases drastically as age decreases, and the longer-term effects of the inoculations on lower age groups will increase their risk-benefit ratio, perhaps substantially.

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The simple and clear reasons why I won’t get vaccinated against COVID-19 — Jacques Pollini | Agoravox: le média citoyen

Source: Agoravox: le média citoyen (French to English online translation)

by Jacques Pollini (his website)
Monday, December 21, 2020

People around the world are debating whether they are going to get vaccinated against COVID-19. Is this a debate or a trench warfare? It seems that we are in the second situation. How do we get out of this? How can we finally establish a dialogue that allows everyone to leave their entrenchment and make an informed choice? It seems to me that in order to break the deadlock, we have to realize that two separate but related issues arise: the issue of vaccine efficacy and safety, which is a scientific issue, and trust in decision-makers, which is a political issue.

For the first question, only a few handfuls of individuals can answer. An ordinary citizen does not have the technical skills to judge whether COVID-19 vaccines will be effective and harmless or not. Our choice can therefore only be based on the answer we give to the second question, that is, our confidence in our decision-makers.

This is a particularly acute issue because the technology used in these vaccines is new. These are RNA vaccines, i.e. fragments of genetic code will be injected into our bodies, with the goal that viral proteins encoded by this RNA are produced by our body’s cells, triggering an immune response (Ulmer et al. 2012).

This technology raises many questions, including the risk of RNA fragments in vaccines being transcribed into DNA and integrated into our genome(Velot 2020). The integration of foreign genetic code with host cell DNA is a common occurrence, as evidenced by the fact that human DNA contains inherited virus sequences. Researchers have already discovered human chimeric RNA/SARS-CoV-2, suggesting that fragments of SARS-CoV-2 RNA (the virus that transmits COVID-19) have been transcribed and integrated into human cell DNA (Zhang et al. 2020). This risk associated with RNA vaccines is therefore not something new.

One thing is new, however. In nature, the integration of fragments of foreign genetic codes into the human genome is not related to human intent. It is the result of chance or natural necessities, while with vaccination it becomes possible to choose which code to inject and on which population to inject it. The RNA vaccine, and gene therapies more generally, make it possible to intentionally modify the human genetic code. Engineering is entering a new era in which it no longer deals only with the transformation of the human environment, but can focus on human nature, on our genetic identity. This is where the fundamental shift lies and it raises ethical issues that are overlooked in the ongoing debates on vaccines.

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