Beyond Negative Evidence on COVID Vaccines

Civil Defense Perspectives January 2024 (vol. 39 #1)

The finding of DNA fragments in COVID-19 mRNA vaccines, by standard laboratory methods by professional researchers, has created a great stir. It is actual affirmative evidence of potential danger—but only a first step (tinyurl.com/3af6xf3t).       The scientists, principally Kevin McKernan and Phillip Buckhaults, Ph.D., carefully divulged the limitations of their work, including the small number of vaccine samples and lack of a chain of custody, and emphasized the need for further research.

The reports do not come from the Ivy League or from eminent scientists or from NEJM. Dr. Buckhaults has not yet published his findings, but provided oral testimony before the South Carolina Senate.  McKernan, who has an undergraduate degree in biology, is the founder of Medicinal Genomics, a company that markets test kits and genomics-related services to the cannabis,  hemp, and mushroom industries (tinyurl.com/3ns3ywny). Dr. Buckhaults is a professor in the College of Pharmacy at the University of South Carolina.

The work is under attack, and the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) deny that the “small” quantities of DNA fragments are a problem. The FDA sets a regulatory threshold for residual DNA, and the tested samples reportedly exceeded this. An EMA spokesperson said the agency was not “aware of scientific evidence showing that the…residual DNA that may be present in vaccine batches could integrate into the DNA of vaccinated individuals” (ibid.). And “there isn’t evidence to date that the vaccines cause cancer or have led to an increase in cancer” (ibid.).

Florida Surgeon General Joseph Ladapo, M.D., Ph.D., “slams the FDA for failing to follow its own requirements for testing whether or not the DNA has integrated into the human genome” (http://tinyurl.com/ahecn9fm). Dr. Ladapo has called for mRNA COVID-19 vaccines to be taken off the market. That brings to one the number of public health officials making such a recommendation, and of the number of elected officials (Gov. Ron DeSantis) who have appointed someone with that opinion. However, Mary Talley Bowden, M.D., states that “we now have 65 candidates and 47 elected officials…from 25 states publicly stating the COVID shots must be pulled off the market,” with 17,000 physicians publicly standing behind them (http://tinyurl.com/bdhf9kc5).

Why Is There DNA in the Vaccines?

 DNA is required to code for mRNA. But it is supposed to be removed in the final stages of manufacturing. The Pfizer vaccine used in the clinical trials used a DNA template created by a polymerase chain reaction (PCR) (Process 1). In scaling up the manufacturing to make millions of doses, Pfizer substituted a cheaper process, using plasmid DNA replicated in bacterial cells. Plasmids are small circular, double-stranded pieces of DNA that can be found naturally within bacterial cells, or can be produced artificially to serve as vectors in procedures used in genetic engineering. This cruder but faster method (Process 2) was said by manufacturer and regulators to yield “similar product.”

“Out of an abundance of caution,” the level of residual DNA is to be minimized through careful purification steps during vaccine production, and every vaccine lot is to be carefully tested for the residual level. Regulators claim that vaccines with higher-than-accepted levels are not supposed to be released for public distribution. They seemed to have missed some.

Manufacturers and regulators assert that any leftover plasmid DNA is biologically inert. Integration of isolated fragments of foreign DNA into the human genome is a very rare and complex event that requires several factors and steps to occur. Humans, like other vertebrates, are exposed to fragments of foreign DNA entering their gastrointestinal tracts and even bloodstream. However, organisms did not previously encounter DNA fragments packed into a protective lipid layer and deeply injected rather than being ingested or entering via a superficial wound.

The DNA contaminants include the promoter sequence from the genome of the SV40 virus (not the virus itself). SV40 is known to cause malignancies. Use of the SV40 promoter sequence is common practice in developing vaccines, including the influenza and hepatitis shots that have been administered globally for decades. The promoter is necessary for initiating the transcription of the desired RNA (http://tinyurl.com/43xx86mf).

Is It Adulteration?

It is not clear how much the manufacturers disclosed to regulators about the possible DNA contamination, and how much the agencies glossed over as a “routine matter.”

Is the level of contamination so high and so dangerous that it may meet the legal standard for “adulteration” as defined by the 21 U.S. Code § 351, “Adulterated drugs and devices”? If so, the vaccine may be subject to recall, seizure, and banning. In addition, unequivocally proving the adulteration of the vaccines may enable piercing the shield of legal immunity from liability afforded to COVD-19 vaccine manufacturers under the PREP Act. However, the evidence so far produced is not nearly sufficient.

An unemotional critical appraisal of the evidence concerning internal and internal validity and generalizability concludes that the “current DNA plasmid contamination theory represents an important major step on the long road leading to finding the truth about COVID-19 vaccines.”

Key Questions Raised

Professor Buckhaults, who is very hopeful about miraculous advances from mRNA technology, expressed concern that the plasmid DNA could cause rare but serious side effects such as cardiac arrest or autoimmune diseases. The strong claim that the plasmid DNA can integrate into the human genome and cause mutations or sustained autoimmune attacks is a significant assertion coming from a mainstream academician. “Twenty Greek soldiers wandering around outside the walls of Troy are not a big deal,” he said. “Twenty Greek soldiers packed inside a large wooden horse [such as lipid nanoparticles enabling the DNA to penetrate into the cell nucleus] are a different matter.”

We must ask: Why in the era of the heightened risk aversion (leading to mass lockdowns, mask mandates, shoe removal at airport security, etc.) is such an enormously risky method of vaccine production even allowed?” 


Negative Evidence: COVID Vaccine and Cancer

Cancer is probably the most feared diagnosis. Elaborate and costly precautions are taken to prevent even tiny theoretical risks, if they involve “chemicals” or radiation. New therapeutic agents including vaccines were subject to meticulous pre-marketing testing and post-marketing surveillance for potential carcinogenesis.

Shockingly, a careless exception from those prudent safety measures has been made for the novel mRNA COVID-19 vaccines. Despite the flood of concerns about the increase of the rate and severity of cancers in vaccinated individuals, no serious investigation into the many possible mechanisms of cancer induction was initiated by the authorities or mainstream academic medicine. That counterintuitive lack of logically expected research efforts constitutes “negative evidence.”

Anti-cancer initiatives have always been met with enthusiastic bipartisan support—until now. Instead, legitimate concerns about COVID-vaccine-caused malignancies have been carelessly dismissed by academicians and regulators.

The unexpected lack of concern about the cancer risk can only be understood in the context of the serious political divide in the U.S. The narrative of the “progressives” has an extremely favorable view of COVID-19 vaccines—and the vaccine manufacturers are generous donors to progressive causes. This narrative has been proclaimed as the default national standard because the progressive bloc has full control over the powerful governmental agencies controlling vaccine approval and cancer surveillance (FDA and CDC), academia (the traditional source of expertise on cancer), and the legacy press.

Despite the substantial power advantage of the vaccine proponents, the vaccine-skeptical camp consisting mostly of non-progressives has refused to accept the default narrative of vaccine safety. This is a stalemate—not a victory of vaccine skeptics, but still a considerable and very telling success of common sense over the vested-interest-driven partisan dogma and politicized science.

This issue has highlighted the corruption of medical science by rampant politicization, leading to increasing public distrust. A few dissident, underfunded scientists cannot solve the problem. Understanding the complex issues of carcinogenesis requires modern sophisticated laboratories with well-trained staff, who have the means to organize cancer-oriented pharmacovigilance registries to collect and analyze the large amount of data related to COVID-19 vaccine-related cancer risks. The required thorough reform of academia looks impossible at present, but needs to be the goal of steadfast medical freedom activism (https://jpands.org/vol28no1/orient.pdf).


A Genomic ‘Calling Card’?

Might it be possible to establish causality for some adverse effects, such as autoimmune disease or cancer, associated with mRNA vaccines? Prof. Buckhaults recommended that patients suffering such events should have the DNA in their stem cells sequenced, looking for integration of plasmid DNA, which is one theoretical mechanism. This should be undertaken, he said, by many different laboratories to establish trustworthiness. If genomic integration is occurring, it is critically important to remove fragments of plasmid DNA if the potential of mRNA technology is to be realized. The research needs to be encouraged, and the barriers that currently exist need to be removed. Knowledge of this issue needs to be part of informed consent (see p 1).

COVID-19 Vaccines and Blood Clots

The Johnson & Johnson “one and you’re done” COVID-19 vaccine, nicknamed the “clot shot,” is no longer available in the U.S. But all of the novel vaccines can cause abnormalities in blood clotting (https://jpands.org/vol27no4/orient.pdf).

There are well-recognized theoretical mechanisms that explain why this can be caused by mRNA vaccines. The SARS-CoV-2 spike protein is a common denominator, and COVID-19 itself also causes clots. These can be microthrombi, which obstruct small blood vessels, or macrothrombi, which can cause pulmonary emboli or strokes. An especially tragic case is that of a young woman who took the shot to be allowed to go to nursing school and ended up with quadruple amputations.

There is compelling negative evidence that mainstream medicine is actively covering up knowledge about those adverse reactions and their mechanisms, to the grave detriment of patients, …who are denied the information necessary to give proper informed consent (ibid.).

AstraZeneca is being sued in the UK by a man who suffered a severe stroke and blindness, and another claim is to be launched later by 80 people who claim to have been injured. The company said: “Regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects” (http://tinyurl.com/3f9uew3d).

COVID Vaccines and Sudden Death

Millions of people watched Damar Hamlin collapse on the football field. People have noticed that a lot of athletes have been collapsing on the field, and a high percentage of them die. In addition, there are a lot of obituaries for young, apparently healthy people who died suddenly or unexpectedly. Is sudden death occurring more commonly, or is it just getting more attention in the days of social media (http://tinyurl.com/4tvc94ez)?

Sudden death is not a new or novel phenomenon. The first recorded sudden death took place in ancient Egypt between 2625-2475 B.C. Hippocrates described sudden cardiac death in his Aphorisms II. In 19th century, British physiologist John A. MacWilliam proposed the electrophysiological hypothesis as the most likely explanation of sudden death (tinyurl.com/4j4uejcu).

Some vaccine skeptics discredited themselves by presenting sudden death as a de novo phenomenon—it clearly is not. Sudden deaths likely account for 15–20% of deaths in Western countries. But is it increasing in the vaccinated? Vaccine status is generally not reported. An increased risk of sudden death is clearly not an acceptable tradeoff for a reduction in the current risk of COVID-19 disease. The staggering paucity of efforts to investigate the link is negative evidence suggesting a cover-up (https://jpands.org/vol28no2/orient.pdf).

COVID Vaccines and Neurologic Disorders

Numerous pathogenetic mechanisms for mRNA vaccines to cause neurologic damage include the spike protein itself and the lipid nanoparticle delivery mechanisms. Academic neurologists do not deny the worrisome side effects, but instead minimize their significance, to manipulate the risk/benefit ratio of the vaccines to favor massive vaccination campaigns. Rigorous investigations are needed to answer questions about these devastating effects (https://jpands.org/vol28no3/orient.pdf).

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