By Jeanne A. Rungby, Specialist.
Image by Vecteezy/Margarita Vias.
Both manufacturers and health authorities have failed in safety studies for COVID-19 mRNA products.
A group of highly specialized researchers has prepared a systematic review (Oldfield et al) of which studies should have been conducted prior to the approval of Pfizer's gene therapy-based so-called vaccines(1).
The report is brand new and published in the American Journal of Physicians and Surgeons (1). The report's findings confirm the concerns listed by NORTHgruppen, sent to the Prime Minister, the Minister of Health and the Danish Parliament on 25 November 2024(2).
Are we talking about vaccines?
The first problem the authors point out is that Pfizer and other manufacturers have been allowed to call this mRNA product “vaccines.” By using this trick (a redefinition of vaccines), they have been able to get the product approved without meeting the requirements that apply to gene therapy-based products. Vaccines are traditionally subject to more lenient regulations than other types of invasive medicine, including gene therapy.
However, there are a number of differences between traditional vaccines and this product. This is illustrated in the article's Table 1. It is clear that mRNA vaccines differ significantly from traditional vaccines.
The article then lists which studies should have been conducted preclinically:
Pharmacokinetic and pharmacodynamic studies of the spike protein (the active substance).
It was not carried out studies of what the body does with the encoded spike protein nor how the spike protein acts on tissues and organs. The spike protein produced by modRNA was already known to be toxic (poisonous) via natural SARS-CoV-2 infection. Therefore, health authorities should have put their foot down and demanded these studies be carried out.
In Pfizer/BioNTech's BNT162b2 Module 2.4. Non-clinical Overview,8, p. 17 it says:
Pharmacokinetic studies have not been performed with BNT162b2 and are generally not considered necessary to support the development and approval of vaccine products for infectious diseases (WHO, 2005; WHO, 2014).
The preclinical studies were thus designed to provide data that were insufficient for such a new type of "vaccine".
Why rats?
An important aspect of the preclinical studies is that they were conducted in rats. The species differences between rats and humans are too great for these studies to stand alone. It would be normal to conduct the studies in at least two species (a rodent and a non-rodent species); in this case, the other species would have been macaque primates (monkeys).
The selection of species used for these studies does not correlate with human physiology . Rats in nature are associated with at least 55 different pathogens that can be transmitted to humans; SARS-CoV-2 is not one of them. Therefore, their ACE2 receptors on their cells do not bind to the SARS-CoV-2 spike protein in rats, nor in mice, to which they are closely genetically related. It is therefore incomprehensible that Pfizer has chosen rats as the primary test animal and has not supplemented it with monkeys as a second test animal.
While rats are expected to produce neutralizing antibodies against the encoded spike protein, any potential toxic effects are likely to be due only to the LNPs (lipid nanoparticles) and not to the unbound spike protein . Specifically, they would not be expected to exhibit adverse effects associated with the spike protein as it does not bind to its ACE2 target (recipes). The most relevant rodent species would have been the Chinese golden hamster, which was not used. Knowledge of which experimental animals are closest to humans can reasonably be expected to be available to the approving health authorities.
An unresolved question that is not clear from the article is whether the preclinical studies on rats were conducted based on process 1 or process 2. Process 2 is the commercial process. More on this later.
Biodistribution studies are lacking
It has not been studied where the injected product ends up in the body , including which organs.
In Pfizer/BioNTech's BNT162b2 Module 2.5 Clinical Overview, section 2.5.2.2, Biopharmaceutical Studies, 23, p 27 is written:
Bioavailability and bioequivalence assessments are not relevant to vaccine antigenicity and have not been measured… Vaccine-induced activation of antigen-presenting cells occurs at the injection site (i.e., muscle).
Pfizer/BioNTech thus had no idea how much of the spike protein was formed in the body (in vivo) or where it subsequently distributes in the human body. Furthermore, Pfizer/BioNTech assumed that the modRNA vaccine is located at the injection site and concluded that there was no need to measure the spike protein in the blood.
This conclusion is incorrectly based on Pfizer/BioNTech's own biodistribution study data, which emerged after the FDA's emergency use authorization, which demonstrated that LNPs were distributed to a variety of tissues, likely mediated via the bloodstream.
Pfizer writes that:
Distribution to the liver is likely mediated by LNPs entering the bloodstream.
Therefore, both Pfizer/BioNTech and the FDA knew in advance that it was wrong to assume that spike protein production would be limited to the shoulder muscle .
This was confirmed in a subsequent tissue distribution study in rats with an LNP-formulated luciferase-encoding modRNA (not the mRNA vaccine itself) with exactly the same lipid composition as BNT162b2. The cholesterol in the LNP was radiolabeled, and the signal was then measured in a variety of organs up to (only) 48 hours after administration.
Based on the biodistribution results above, it can be concluded that if Pfizer's mRNA vaccine (BNT162b2) were administered instead of the surrogate, spike protein production would likely also occur in the liver, adrenal glands, spleen, ovaries, and other sites. Although the distribution of the spike protein itself was not studied, it is expected to be extensive, as the spike protein has easy access to the bloodstream.
LNPs select certain tissue types and transport into the cell, making it necessary to measure the effects of the LNPs, the mRNA, and the spike protein separately.
Therefore, biodistribution studies should measure the distribution of each of these components separately and simultaneously, as there is not always a correlation between where lipid nanoparticles are found in the body and where and how much spike protein is produced. These studies were not performed.
There have also been no studies showing risks and toxicity from the accumulation of lipid nanoparticles. It is unclear how the body gets rid of these lipid nanoparticles.
Since lipid nanoparticles have adjuvant-like activities, there was a need for a thorough safety and immunological assessment and probably a longer follow-up on side effects compared to what is required in the WHO guidelines for vaccines from 2005. Furthermore, only about 1-2% of the lipid nanoparticles result in successful transfer to cells, leading to the production of spike protein. It is therefore not fully known how the remaining lipid nanoparticles are used in the body.
Other toxicological studies:
Studies of genotoxicity and carcinogenicity mean that one investigates whether the substance poses a risk of changing human genes and whether it can provoke cancer.
The Pfizer/BioNTech non-clinical summary document, section 2.4.4.4., Genotoxicity,8, p. 29 states:
Genotoxicity studies are not planned for BNT162b2, as the components of the vaccine construct are lipids and RNA and are not expected to have genotoxic potential.
And again, in section 2.4.4.5. Carcinogenicity, the document says:
Carcinogenicity studies have not been conducted with BNT162b2, as the components of the vaccine construct are lipids and RNA and are not expected to have carcinogenic or tumorigenic potential. Carcinogenicity testing is generally not considered necessary to support the development and approval of vaccine products for infectious diseases.
Although BNT162b2 may not be expected to have genotoxic or carcinogenic potential, the encoded spike protein that is produced does. Therefore, these studies should have been carried out. They were not.
Studies for reproductive and developmental toxicity must clarify whether the substance has an impact on the ability to have children and on the development of these children.
These studies were conducted on Wistar HanTM rats, a rodent species that is completely unsuitable for toxicological studies in relation to human physiology. A more relevant species should have been chosen for toxicity studies on developing rat pups.
A study of the distribution of the spike protein in the tissues of both the mother and the offspring would have provided very important information on the suitability of BNT162b2 for administration to pregnant women and lactating mothers. This was not performed. Furthermore, male rats were not studied and data on male fertility are unknown.
Endotoxin
The article does not mention endotoxin, a very potent toxin that is the remnants of cell walls (lipopolysaccharides) from the coli bacteria used to produce mRNA “vaccines” in the commercial process. Endotoxins are known to cause anaphylactic shock, which is fatal if not treated immediately. It is not stated anywhere whether the authorities have ensured and controlled that the product is free of endotoxins.
Clinical studies.
The article by Oldfield et al notes that, since BNT162b2 is not a traditional vaccine, the pharmacokinetics of the encoded spike protein (i.e., the viral antigen) should have been determined as part of a phase I, dose-escalation clinical trial (dose-response study) . This was never investigated. A full pharmacokinetic profile would show the variation in the levels of spike protein produced between individuals. Unfortunately, the variation remains unknown.
In addition, side effects could have been correlated with spike protein concentrations in the blood. These are basic studies to understand the safety of modRNA vaccines.
Security:
From December 1, 2020 to February 28, 2021, a 3-month period, 1223 deaths were recorded in Pfizer’s own documents , which were released by judgment. Such a high mortality rate after medical intervention would have resulted in any other drug being taken off the market immediately. Therefore, one must ask: Why were the mRNA vaccines allowed to be used?
The outcome for 9,400 people is classified as “unknown.” How many of them died? There were also 6,876 people whose ages could not be determined. How many of the 11,361 who had not recovered at the time of this initial report subsequently died? Was it simply poor documentation, or is there another explanation? Regardless, such shortcomings in the documentation of a regulated study should have been investigated further and the results documented.
By February 2021, both Pfizer/BioNTech and the FDA were already aware that the product was associated with significant dangers. Vaccine-related adverse events were documented in VAERS at an alarming rate. But COVID-19 modRNA vaccines are still being touted as highly effective by public authorities, who are urging as many people as possible to be vaccinated with the latest booster vaccines. In the meantime, these authorities are accepting a higher death rate than would otherwise be tolerated by any other vaccine or medicine. This death rate is accepted as “collateral damage” in the service of a good cause. But is the assumption that COVID-19 modRNA vaccines are highly effective even correct? There are two points to consider.
1. Is there conclusive evidence that the COVID-19 modRNA vaccines stopped the spread of infection and saved lives, i.e. do the potential benefits outweigh the known risks?
2. Were there alternative medicines that are safe, effective, and readily available for treating patients infected with COVID-19?
Efficiency
The first clinical trials based on Process 1 were all stopped early and had serious flaws in offering the control group the vaccine after only a few months. The unblinding of placebo patients to receive the vaccine was criticized by researchers due to the loss of future reliable data, especially in the elderly. This unblinding “will set a de facto standard for all future vaccine trials.”
Therefore, in the absence of randomized clinical trials with sufficient power, it is impossible to definitively demonstrate that COVID-19 modRNA vaccines are effective in reducing the endpoint of mild COVID-19 disease. There has been no prospective, double-blind, randomized, placebo-controlled trial of COVID-19 vaccination that has shown a reduction in hospitalizations and deaths.
In this context, a recent study by Andersson et al should be mentioned, in which it is claimed that last year (2023) they found a 58 percent comparative effect of the Covid-19 vaccine on the risk of hospitalization and a 75 percent effect in relation to death(5). The comparison group is called "non-recipients", which could lead to the belief that the comparison is with unvaccinated people (placebo).
On the other hand, it is a comparison between the group that received the 5th or 6th COVID-19 booster vaccine compared to those who had already received at least 4 Covid-19 injections a year or more ago. The authors (from SSI) have therefore deliberately chosen to compare with a group that has been documented(6) to have reached the phase that implies a negative effect; that is, a group with a weakened immune system, and therefore an increased risk of Covid-19. Another thing that has conveniently been omitted from the study by Anderson et al (3) regarding the studied group is the period from the injection to one week onwards, when most deaths and serious early side effects traditionally occur. This is perceived as data manipulation in order to reach conclusions that can justify a political decision that the authorities continue to give these COVID-19 gene therapy-based vaccines to people over 65 years of age, immunocompromised and pregnant women.
Likewise, no valid non-randomized study controlling for early multidrug therapy, natural immunity, and progressively milder strains of SARS-CoV-2 has shown that vaccination was associated with reductions in the endpoint, COVID-19 disease. . Furthermore, how can efficacy be demonstrated when it is now known that these vaccines do not prevent transmission or occurrence of the disease? Finally, the available studies showed that any theoretical protective effect of vaccination lasted less than six months (1, 6).
Alternative safe and effective treatments for COVID-19
On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech's COVID-19 vaccine for distribution in the United States.
“For the FDA to issue an EUA, there must be no suitable, approved, and available alternative to the candidate product for the diagnosis, prevention, or treatment of the disease or condition.”
However, early in the COVID-19 pandemic, there was overwhelming evidence that Ivermectin (IVM) and hydroxychloroquine (HCQ)-based multidrug protocols were active agents when used early against COVID-19. Yet, government and medical literature demonized off-label drug treatment of COVID-19 patients in favor of COVID-19 modRNA vaccines.
There were several randomized control trials that were poorly designed and conducted, and yet these results were widely cited by the media and government policy recommendations as evidence that IVM was ineffective against COVID-19.
IVM has been on the market for more than 40 years with more than 4 billion treatments, and it has been shown to be safe (see Table 4). However, treatments with repurposed drugs like IVM were even banned by government authorities for the treatment of COVID-19, and more toxic and unproven treatments like remdesivir and COVID-19 modRNA vaccines used under EUA were promoted instead.
Supervision:
Monitoring mRNA vaccines is the responsibility of regulatory authorities. The alarm signals for these products have been unbelievably ignored.
The current situation
Although the mortality rate from COVID-19 has decreased significantly, people are still encouraged to stay up to date with their COVID-19 modRNA vaccine booster shots. Another issue is that “long COVID” and “vaccine injury” have very similar clinical appearances, and the adverse effects of the COVID-19 modRNA vaccines continue to accumulate. Short-term adverse effects associated with the spike protein include, but are not limited to: myocarditis, other inflammatory conditions, autoimmune disease, blood clots, neurological disease, multiorgan failure and vaccine-related cases of long COVID (1)
DNA
The article by Oldfield et al mentions the issue of contamination with genetically modified DNA in vaccines, which makes studies on the genotoxic and carcinogenic potential of these products particularly relevant.
It is a serious failure on the part of the regulatory authorities to turn a blind eye to Pfizer's shift of manufacturing process from the “clinical trial process 1” to the “commercial process 2.” These 2 processes are substantially and significantly different.
The approvals and information for vaccinees are based on the clinical trials based on process 1.
On the other hand, it is the commercial process 2, which takes place by cultivating E-coli bacteria with recombinant plasmid DNA, which is given to a large part of the world's population, that has made the contamination with recombinant plasmid DNA from the manufacturing process possible.
The Danish Medicines Agency has responded to the inquiry as follows (case number 2024024182) on 12 August 2024(7):
· That there are no placebo-controlled randomized clinical studies in humans with material from process 2 for Cormirnaty.
· That no objection was raised by the Danish Medicines Agency when Pfizer switched from process 1 to process 2.
This is a clear admission of a failure in the regulatory process(7).
In the NORTHgruppen lay summary, which was submitted to ministers of state and health on 25 November 2024 in 13 countries in Europe (3), the problems of process 2 are presented as follows:
» The DNA identified in the vials is artificial and foreign genetic material, copied and amplified in E. coli bacteria and used as a template to produce the mRNA encoding the Spike protein. However, this DNA should have been degraded and effectively removed from the mRNA component before encapsulating purified mRNA into LNPs. Critically, the artificial plasmid DNA contains sequences that allow the DNA to be copied in both bacteria and, in the case of Pfizer's vaccine; in human cells, posing a significant but completely unnecessary health risk.
Dr. David Speicher, an independent researcher from the University of Guelph, Canada, measured the amount of DNA in three vials of COVID-19 modified mRNA products retrieved from refrigerated facilities of registered Australian healthcare professionals.
Dr. Speicher found that all vials contained measurable levels of residual plasmid DNA, exceeding the regulatory limit of 10 ng/dose set by the WHO by 7.8-145 times.
Dr. Speicher also confirmed the presence of a specific DNA sequence from Simian Virus 40 (SV40) in the Pfizer vaccine. This piece of DNA (known as the SV40 promoter-enhancer) was not declared to regulatory authorities as part of the vaccine manufacturing process.
If Pfizer had declared this component in their manufacturing process, it is likely that it would have led to greater scrutiny, as SV40 virus is associated with cancer and the SV40 promoter-enhancer itself has potent biological activity.
Therefore, the presence of this sequence in the Pfizer product poses a much more serious risk than the presence of simply too much DNA.
This SV40 promoter-enhancer is typically used in genetic engineering or gene therapy. When this DNA crosses the cell membrane, as would happen in an LNP, this SV40 enhancer sequence can target the associated DNA to the cell nucleus, where it can cause changes in the human DNA .
In short: the SV40 enhancer increases the likelihood of modification of the human genome.
The summary also states:
» Dr. Speicher's findings corroborate multiple studies that also identified the SV40 enhancer sequence in the DNA of Pfizer's products. The risks associated with these undeclared components in the COVID-19 modified mRNA products have not been investigated and have not been disclosed to recipients. This is inexcusable.
It is not a question of whether residual plasmid DNA in LNPs integrates into the DNA of human cells, but how often it happens and how bad the effects are.
It should be noted that DNA integration is not required to induce cancer-associated pathways. The genetic risks to humans who have received these products, as well as their offspring, are unknown. There is an urgent need for scientific studies to determine the risks of gene-based mRNA therapy to humans.
Regulatory authorities on the possibility of integration.
The Danish Medicines Agency, on behalf of the Minister of Health, has admitted that the DNA plasmid used in Pfizer's vaccine contains a very small "slice" of an SV40 virus. They claim that it is unlikely that these sequences will pose a risk of cancer development or be able to cause damage to human DNA. According to the Danish Medicines Agency, there is no risk of inheritance to the next generation.
This response from the Danish Medicines Agency (4) is almost identical to responses from other drug authorities around the world, including the response from the United States Food and Drug Administration (FDA) to Florida State Surgeon General Dr. Joseph Ladapo, who in January of this year called for a halt to the use of modified mRNA vaccines until safety is proven, after the FDA could not provide a satisfactory explanation for the DNA contamination.
This lack of concern on the part of the authorities is deeply worrying, and the fact that the authorities have not prosecuted the manufacturers for not disclosing all the sequences used in the production of their products casts a further, very dark shadow over the lack of impartiality of the regulatory authorities.
Safe and effective vaccines cannot be produced if authorities do not act in the public interest.
The full lay summary with sources can be read in reference no. 2.
Since the rollout of the COVID-19 vaccine in 2021, there has been a large increase in morbidity and mortality due to malignant neoplasms.(1) According to Oldfield et al, there are several mechanisms that can explain the observed association between the vaccine and the risk of oncogenesis, including the SV40 enhancer found in the Pfizer/BioNTech COVID-19 modRNA vaccines.
Preliminary work conducted in Germany has found evidence of genomic integration of the entire COVID-19 vaccine spike DNA into the genome at chromosomes 9 and 12. Therefore, integration into the human genome is possible, and the integration may well be found in cells of a vaccinated person. Furthermore, the SV40 promoter can bind to the p53 tumor suppressor gene (the guardian of the genome) and potentially inactivate p53, providing another mechanism for increased cancer risk.
The study by Oldfield et al states that some scientific publications associate cancer and other diseases exclusively with COVID-19 infection. In these publications, the authors had not considered the possibility that the vaccines could also be responsible for these pathologies, since the presence of the spike protein is common to both. Due to incomplete data from randomized and observational studies, it may be difficult to distinguish between adverse effects of the COVID-19 vaccines and complications after COVID-19. However, since it is possible that the spike protein produced by both the virus and the vaccine is responsible for these pathologies, it is prudent to accept that both are potentially responsible for these increases in cancer.
Immune tolerance to SARS-CoV-2 infection occurs when a person has been exposed to the spike protein over a prolonged period of time after multiple boosters of the COVID-19 modRNA vaccine. The consequences of this are repeated and more severe SARS-CoV-2 infections. The mRNA used in these vaccines is modified to increase mRNA stability, This allows the spike protein to be generated over a longer period of time. This can have serious consequences, especially if a person has a weakened immune system or is immunotolerant.
Circulating vaccine-generated spike protein can cause a variety of well-documented vaccine-related harms(1).
Summary:
· COVID-19 mRNA was defined as a vaccine, even though it was a gene therapy-based product, which opened the door to significantly relaxed regulatory requirements.
· The effect of the final product itself, the spike protein, in the body was never studied in either humans or experimental animals. Nor were dose-response studies for spike protein conducted.
· The manufacturers used the wrong test animals, rats, in the preclinical trials, even though it is well known that their physiology is significantly different from humans, including the receptors to which the spike protein binds.
· No studies were conducted on which organs the product would reach before the emergency approval (the conditional approval) was granted. Pfizer knew that the product would not stay in the shoulder muscle.
· No studies were conducted on the potential toxic effects of lipid nanoparticles, nor how they are cleared from the body.
· No studies were conducted on possible changes in the human genome and risk of cancer.
· Reproduction studies were conducted on pregnant female rats, which cannot be compared to humans. Offspring were not properly studied.
· The process change was ignored after approval was given.
· residual DNA contamination, as a result of process changes, was not investigated with the correct methods and therefore underestimated.
· Severely inadequate monitoring of side effects in the monitoring centers. Alarm signals were ignored.
Conclusion.
The studies that Pfizer/BioNTech provided to the FDA and other regulatory authorities were fundamentally flawed and inadequate.
Various drug regulatory authorities and authorities did not carry out the required checks.
The monitoring of these conditionally/emergency approved products failed, with countless red flags being ignored.
For any other drug, the application would have been considered incomplete and most likely rejected. Therefore, at a minimum, a moratorium (temporary stop) should be imposed on the use of the Pfizer/BioNTech COVID-19 vaccines and boosters, but ideally, they should be removed from the market and their use in humans should be stopped. It should be the responsibility of the pharmaceutical industry, not independent researchers, to determine whether a medical intervention is safe.
Based on Pfizer/BioNTech's data, the safety of their COVID-19 anti-RNA vaccine has not been proven.
References
1. Journal of American Physicians and Surgeons Volume 29 Number 4 Winter 2024: Pfizer/BioNTech's COVID-19 modRNA Vaccines: Dangerous Genetic Mechanism of Action. Released before Sufficient Preclinical Testing. Philip R. Oldfield, D.Phil.; L. Maria Gutschi, B.Sc .Phm, Pharm.D.; Peter A. McCullough, MD, MPH; David J. Speicher, Ph.D. https://jpands.org/vol29no4/oldfield.pdf
2. NORTHgroup Lay summary:
and
6. https://www.medrxiv.org/content/10.1101/2021.12.20.21267966v3.full.pdf?fbclid=IwAR1OROghCFpb9mmkJjvG1esNezO mdUoEZHTvsFXXotnV0Jr6XRImpzWaMT4
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