The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent – A Perspective


Part One continues below, from the April 2020 print issue…

Correlation Does Not Imply Causality, But…

“Both the epidemics of type 1 diabetes and metabolic syndrome correlate with an increase in immunization.”39

The consumption of organic food increased at the same time many chronic childhood illnesses increased in the US, and no one would argue that organic produce has caused that increase; but when there are known poisons applied to the population at the same time as the plethora of chronic childhood illnesses increases, logic would call out the poisons in question before pointing the finger at organic fruits and vegetables.

When vaccines were found contaminated with glass fragments made by one manufacturer, the FDA just accepted that the contamination would pose no risk because the manufacturer said so; and the FDA ignored it. Curiously, they are not ignoring the issue of retroviral contamination of vaccines and have launched an investigation into this danger that is not disclosed to those who will get vaccinated. So, from the FDA website: “These latent, or ‘quiet,’ viruses pose a potential threat, since they might become active under vaccine manufacturing conditions.”40

That is an interesting admission that the FDA doesn’t actually know what level of threat these quiet viruses pose, given they did absolutely nothing when well over 98 million people were given the cancer-causing Simian Virus 40 (SV40) via the polio vaccine. A thorough review of the iatrogenic transmission of pathogenic agents via vaccine is beyond the scope here, but the facts are readily available to those willing to observe what the FDA did in the case of the rotavirus vaccines.

Two new genetically engineered oral rotavirus vaccines entered the vaccine marketplace in 2006 and 2008, respectively: RotaTeq, a pentavalent (five-strain) bovine-human reassortant rotavirus vaccine made by Merck, and Rotarix, a live-attenuated single-human-strain rotavirus vaccine manufactured by GlaxoSmithKline (GSK). Although pre-licensure trials found no evidence of an association between the two vaccines and intussusception, post-licensure monitoring later indicated a statistically significant increased risk of intussusception events for all rotavirus vaccines.41 The FDA merely instructed Merck, in 2013, and GSK, in 2014, to update their labeling and prescribing information to include brief statements about increased intussusception risks but otherwise allowed the two vaccines to remain on the market.

Meanwhile, the governmental safety systems, oft purported to be rigorous, that ushered the two rotavirus vaccines to market failed to detect an additional and highly concerning problem, which an academic research team “unexpectedly”42 identified in 2010. While conducting “a novel, highly sensitive analysis not routinely used for adventitious agent screening,” the researchers discovered that RotaTeq and Rotarix were contaminated with DNA from two porcine circoviruses—type 1 (in Rotarix) and both type 1 and 2 (in RotaTeq). Both GSK and Merck later confirmed these findings. The porcine circovirus 2 pathogen is associated with severe wasting and immunodeficiency in pigs.

Although the dangers from these viruses are unknown, horizontal gene transfer—the direct uptake and incorporation of genetic material from unrelated species—is a clear risk of genetically engineered vaccines.43 Unlike chemical pollutants, nucleic acids are infectious and can invade cells and genomes, multiplying, mutating, and recombining indefinitely. Potential hazards of horizontal gene transfer include generation of new disease-causing viruses and bacteria (or reactivation of dormant viruses); spread of drug and antibiotic resistance genes among viral and bacterial pathogens; and random insertion into genomes of cells resulting in cancer.

Of great concern, outside of regulatory circles, is research demonstrating that the pathogenic potential of Porcine Circovirus-2 to cause an AIDS-like disease in pigs is unleashed when there is simultaneous vaccine-induced immune system activation.44

At a 2010 meeting convened by the FDA to discuss this contamination, a GSK executive went so far as to concede, “evolving technologies can lead to new findings that were not known at the time of licensure.” The contamination of vaccine with viruses that can potentially cause cancer decades after vaccination, as the SV40 virus seems to have done, is downplayed as a “manufacturing quality issue” and swept under the rug. The space under that proverbial rug is crowded with one vaccine controversy after another, from the vaccine trials for the so-called Spanish flu epidemic (1918) that seems to have been the result of a botched military vaccine experiment that went on to cost over 100 million lives, the notorious Cutter incident that left many crippled and some dead, as a result of vaccine-induced polio (1955), and the transmission of the cancerous SV40 virus to almost 100 million, just to name three.  Nonetheless, the GSK researchers45 expressed little worry, having framed the presence of the viral DNA in their vaccine as a simple manufacturing issue rather than a safety risk.

Are Unforeseen Outcomes Inevitable?

Shortly after the GSK discovery, FDA recommended that physicians temporarily suspend use of Rotarix and switch to RotaTeq,46 but when Merck’s vaccine was found to contain similar contaminants, FDA reversed course and allowed continued use of both. Instead of calling for new safety studies and completing a new risk-benefit analysis (taking into consideration that mortality from rotavirus disease in the US is very low), the FDA once again reassured the public that the benefits of rotavirus vaccination outweighed any “hypothetical” health risks of viral contamination. The agency’s sole follow-up action was to rubber-stamp updates to the Merck and GSK package inserts to “reflect the presence of Porcine Circovirus Type-1 and -2 DNA in the vaccine[s].”

SV40 is “occasionally” finding its way into the vaccine even today.47 Why is this being tolerated? How can the benefits outweigh the risks when, in addition to the proven risks, the scientific evidence reveals multitudes of under-appreciated risks? There is persuasive evidence that SV40 is present in human ependymomas, choroid plexus tumors, bone tumors, and mesotheliomas. A 2002 Institute of Medicine report cited strong biological evidence that SV40 can transform normal cells into malignant cells. Whether the porcine circovirus contamination that afflicts the two current—and highly engineered—rotavirus vaccines will turn out to have insidious long-term health effects remains an unanswered question.

Gatti and Montanari48 revealed, for the first time, that vaccines had more than aluminum salts adjuvants, polysorbate-80, and other inorganic chemicals in them; they also harbored stainless steel, tungsten, copper, mercury and rare elements that probably shouldn’t be injected directly into the human body, but what do regulators do with this information?

Gatti was about to testify in a parliament enquiry on vaccine damages when her lab was raided by police and all their research materials confiscated. They had crossed the line by finding nano-contamination in random vaccines, Gatti and Montanari revealed, for the first time, what no one knew – information that could potentially make the public question the safety of vaccines. That kind of revelation is just not “allowed to exist.”  Take this one step farther and those who question vaccine safety are not “allowed to exist.”

But assume, for the sake of argument, that vaccines are generally safe, they still will have unintended consequences. From the article, “Vaccination can drive an increase in frequencies of antibiotic resistance among nonvaccine serotypes of Streptococcus pneumoniae”49:

The bacterial pathogen Streptococcus pneumoniae is a major public health concern, being responsible for more than 1.5 million deaths annually through pneumonia, meningitis, and septicemia. Available vaccines target only a subset of serotypes, so vaccination is often accompanied by a rise in the frequency of nonvaccine serotypes. Epidemiological studies suggest that such a change in serotype frequencies is often coupled with an increase of antibiotic resistance among nonvaccine serotypes…we find that vaccination can result in a rapid increase in the frequency of preexisting resistant variants of nonvaccine serotypes due to the removal of competition from vaccine serotypes.49

The pneumococcal vaccine is not the only vaccine that has the potential to increase strains not covered in the vaccine that are much more problematic than the strain covered by the vaccine—for example, the HPV and Hib vaccines. If this were about science and in the interest of public safety, then the use of the vaccine would be suspended until this issue was sorted out.

In 2006, researchers wrote in the Journal of Toxicology and Environmental Health45:

Genetically modified (GM) viruses and genetically engineered virus-vector vaccines possess significant unpredictability and a number of inherent harmful potential hazards… Horizontal transfer of genes… is well established. New hybrid virus progenies resulting from genetic recombination between genetically engineered vaccine viruses and their naturally occurring relatives may possess totally unpredictable characteristics with regard to host preferences and disease-causing potentials.

There is inadequate knowledge to define either the probability of unintended events or the consequences of genetic modifications. (emphasis added)

Though this was 12 years ago, little has changed even as the technology has advanced. Today pharma has several different types of GM vaccines in production and in development. But what happens when foreign DNA is inserted into the human body is an evolving mystery. Will it trigger undesirable changes in human cells or tissues? Will it combine or exchange genetic material with human DNA? Will it transfer to future generations? No one knows if no one is looking.

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