McKernan: DNA Contamination in Covid Shots #Plasmidgate

Kevin McKernan's discovered genetic material contaminants and it's off the charts

EDIT: They say imitation is the greatest form of flattery. This article that highlights Kevin McKernan's work and links it to regulatory documents and patient issues appears to have passed a form of peer review. It's been lifted in very significant part by @dragonfishy AKA Dr. Paul Oosterhuis, who's actually asking people to pay him for his 5 minute copy and paste job from this article that was written from scratch while literally scratching my head through McKernan's primary and complex research! The first time VST has been plagiarized. Our advice is to not buy a Paul a coffee. Give your money to the nearest homeless person instead.

This article aims to provide:

• a lay summary of the first (ongoing) research into the genetic content of Pfizer and Moderna Covid gene therapies;

• an outline of the potential ramifications, with reference to other research and context.

This is done in order to:

• increase awareness of the issues implicit and explicit to the research and increase its circulation and accessibility;

because the issues at the heart of the research are of fundamental importance. The detailed technical nature of the primary research is hard to penetrate and yet the lay person needs to understand its implications.

Kevin McKernan

Kevin McKernan is publishing primary scientific research direct to substack for peer review. Since mid February he has been sequencing the contents of the Pfizer and Moderna bivalent Covid gene therapies. This month, he’s shifted to Pfizer’s monovalent vaccine, which was the first Covid gene therapy Pfizer released. In short, his findings are bad, bad news.

https://twitter.com/Kevin_McKernan

McKernan is an established, accomplished scientist in the field of genomics who has expertise in genomic sequencing technologies. Read his company bio here. Early in the pandemic, McKernan was vocal and critical about the use of PCR testing for Covid in general. His substack is below.

McKernan’s initial findings

A key caveat stated by McKernan is the shelf-life of the products he analysed. In the case of the Pfizer monovalent test, the sample was dated 3/4/2022. McKernan acknowledges that the effect of shelf life is unknown and more analysis on samples with improved chain of custody and storage conditions are warranted. This is an important limitation, but it doesn’t automatically invalidate much, if any, of what follows.

1. RNA fragmentation is evident in both brands and all lots but is particularly notable in Pfizer vials. Surprisingly, mRNA products longer than the anticipated length of the mRNA were also observed in the bivalent vaccines. These longer fragments are note [sic] seen in Patel et al. with the monovalent vaccines.

   1. The presence of fragmented RNA and mRNA that is out of active ingredient specifications (“longer”) has been detected in bivalent product samples. How, why and to what effect are all open questions.

2. Two different expression vectors are found in the Moderna bivalent vaccines. Two different lots were sequenced and there may different background expression plasmids in each lot.

   1. “An expression vector, otherwise known as an expression construct, is usually a plasmid or virus designed for gene expression in cells. The vector is used to introduce a specific gene into a target cell, and can commandeer the cell's mechanism for protein synthesis to produce the protein encoded by the gene… Expression vectors are the basic tools in biotechnology for the production of proteins.” source

   2. McKernan’s investigative method has revealed the presence of genetic material (expression vectors) that are remnants of the mRNA manufacturing process.

3. Of interest, this Moderna vaccine vector sequence has 99.8% identical sequence to the plasmids discovered in Pseudomonas aeruginosa samples which were famously edited from NCBI after spike protein sequence was identified in them. At the time, there was a healthy debate regarding if these plasmids would remain at high copy number in their host without any antibiotic selective pressure.

   1. “A plasmid is an extrachromosomal DNA molecule that is physically separated from chromosomal DNA and can replicate independently. Plasmids naturally exist in bacterial cells, as well as some eukaryotes, and the genes carried in them often provide bacteria with genetic advantages such as antibiotic resistance. To design, modify or construct a plasmid one needs to understand the specific components that make up it and why each is important.” Source

   2. The genetic sequence of an expression vector in the Moderna vaccine is a 99.8% match to plasmid contaminants found in related research. Those plasmids are manmade, display antibiotic resistance and are potentially associated with the manufacturing process of the mRNA active substance of the Covid gene therapies.

   3. In short, this indicates the presence of the genetic manufacturing tools used to make the mRNA, in the Moderna product.

4. The EMA set limits for dsDNA contamination at less than 330ng/mg RNA. This is roughly 1 part per 3,030 mRNA molecules. It is not clear how they set these standards… The sequencing evidence we now have on hand confirms that most of this DNA is in-fact the expression plasmid DNA, complete with spike protein, SV40 mammalian expression promoters, aminoglycoside antibiotic resistance and high copy origins of replication that are compatible with both mammalian expression and bacterial amplification.

   1. dsDNA (double strand DNA) is what makes up the discovered plasmids, and a limit for it in the products was set by the EMA but how is unknown.

   2. “Artificial plasmids are widely used as vectors in molecular cloning, serving to drive the replication of recombinant DNA sequences within host organisms. In the laboratory, plasmids may be introduced into a cell via transformation.” Source

5. The vectors contain mammalian promoters, bacterial origins of replication in addition to the neomycin and kanamycin resistance genes. Circular plasmids like this are used for stable transfection and continued expression of genes in mammalian cells with the strong SV40 promoter.

   1. The contaminant is therefore the plasmids, which have bacterial origins (their manufacture employed E. Coli), can replicate and interact in mammalian and bacterial cells, and are resistant to neomycin and kanamycin antibiotics (used in fighting gut infections).

6. A quick estimate… equates to 1 vector for every 3,000 mRNAs. The Pfizer vials have an order of magnitude higher rates of contamination. This is consistent with the fragment analysis having more off-target peaks.

   1. McKernan has found contaminants in Moderna and Pfizer monovalent and bivalent gene therapy samples.

   2. McKernan initially estimated the ratio of contamination to desired, specified mRNA active ingredient in the Moderna shot as 1 DNA molecule to 3000 RNA molecules, and flagged that the Pfizer samples are an order of magnitude beyond this contamination level (1:350).

7. This is unequivocal evidence that the contaminating vector sequence is double stranded DNA and not RNA.

   1. McKernan confirms that the genetic material contaminant is DNA, and therefore cannot be some form of corruption of the final active mRNA ingredient.

This is a lot to take in. McKernan’s papers are dense and technical. Let’s simplify what points 1 - 7 mean so far.

The manufacturing process for the mRNA active substance (payload) of the Covid gene therapies involves growing engineered E. Coli bacteria that contains circular dsDNA plasmids. Those plasmids are the expression vectors from which the mRNA active substance is derived. The plasmids are in themselves replication competent i.e. they have the innate capability to enter (transfect) a host mammalian cell and replicate there, but are also able to transfect bacterial cells and replicate between 50 and 300 copies of themselves. The engineered plasmid’s genetic sequence contains code for spike protein and so its replication could itself produce spike protein under certain circumstances. Furthermore, these plasmids display antibiotic resistance as an artefact of their design and production, which becomes relevant later. So, if a host was injected with these plasmids (in this case as an unwanted contaminant), they could replicate inside the host’s cells. If the replication conditions were appropriate, spike protein could be generated in the host, in addition to any spike protein that was generated by the separate mRNA payload (the intended method of action of the Covid gene therapies). It is not clear as yet whether these plasmids, if replicating inside other bacterial cells, would produce spike protein. Again, this becomes important later.

As a fundamental base concept outside of Covid gene therapies, dsDNA is employed in DNA vaccine technology. Injecting someone with a dsDNA vaccine induces a human immune response via stimulator of Interferon genes (STING), although the exact reasons why and how are not fully known.

Let’s recap and combine what McKernan has found with what he knows from broader research.

• The shots contain dsDNA (circular and linearized) plasmid contaminants that are replication competent in human cells and bacterial cells, antibiotic resistant and carry the spike protein coding.

• Moderna samples were initially estimated to conform to the EMA’s contaminant limit (1:3000). Pfizer’s did not, by an order of magnitude (1:350).

• The plasmids are an undesired artefact of the industrial manufacturing process of the mRNA payload, which raises questions about the manufacturing process quality control, assurance and oversight, specifically around purification of the mRNA payload from the engineered E.Coli and the plasmids they contain.

• The formulation of the Covid gene therapies comprises the LNP components, the mRNA payload and the dsDNA plasmid contaminant.

• At working temperature, the LNP components self-form into “lipid wrappers” that encapsulate, protect and deliver the mRNA, but have the potential capability to do the same for the dsDNA plasmid contaminant.

• The host/patient could be receiving a combination of:

  • mRNA payload with a capacity to produce an intended amount of spike protein; plus

  • an unintended and unknown amount of dsDNA plasmid with a capability to radically replicate itself inside the host’s cells and also inside bacterial cells inside the host’s own gut microbiome, should the plasmids make it into the host gut.

• Per available manufacturer biodistribution studies, it is now known that LNPs build up in the intestines over the observed initial 48 hours post injection, implying that should LNPs encapsulate the dsDNA plasmid contaminant, the LNPs will carry it into the host gut and provide access to the bacteria there.

• Should this occur, the host could experience a radical increase of plasmid burden as it replicates in the gut, with unknown effect. In order to stop the replication, a logical step would involve using antibiotics to kill the plasmids and the host bacteria in the gut. Trouble is, the plasmid is antibiotic resistant by design and may survive (“the selection of neomycin and kanamycin resistant bacteria in the gut microbiome”).

McKernan concludes his first paper thusly:

These are potent contaminants in the vaccines being administered to children. Billions of these contaminants per injection is likely an under estimate of their the entire burden as these plasmids can self replicate in bacterial hosts. Multiple studies have demonstrated prolonged vaccine mRNA clearance. This could be the result of the m1Ψ in the mRNA or the transfection or transformation of DNA based expression vectors. The introduction of billions of antibiotic resistance genes in high copy replication competent plasmids should evoke concerns over accelerating global antibiotic resistance.

Contaminant estimation and circular versus linearized plasmids

McKernan found evidence of circular and linearized plasmid contaminants, the fundamental difference between the two being that linearized plasmids are replication competent to a lesser degree i.e. they produce fewer copies of themselves.

Edit via Kevin McKernan:

We don’t yet have good quants on how much of this DNA is linear or circular and at the moment the transformation efficiency is very low.

Regarding low transformation efficiency, “transformation efficiency refers to the ability of a cell to take up and incorporate exogenous DNA, such as plasmids, during a process called transformation. The efficiency of transformation is typically measured as the number of transformants (cells that have taken up the exogenous DNA) per microgram of DNA added to the cells. A higher transformation efficiency means that more cells are able to take up the DNA, and a lower efficiency means that fewer cells are able to do so.”

So, at present, it McKernan states that the plasmid DNA has a low ability to be taken up by host cells.

He also acknowledged that the investigative methods employed inherently suppressed the amplification and therefore the quantification of the amount of DNA in samples. This led him to suspect that his estimates of 1:3000 and 1:350 DNA to RNA were likely an underestimate, which he has confirmed.

Using qPCR and electrophoresis, we demonstrate the dsDNA contamination levels are 100 fold higher and imply trillions of DNA molecules per dose. The DNA contamination ranges from 8.19-11.3 ng/ul with 23-55ng/ul of mRNA. This equates to 20-35% of the nucleic acid in each vaccine being expression vector. This is several orders of magnitude over the the EMAs limit of 330ng/mg.

Edit via Kevin McKernan:

The 20-35% comes from the Agilent tape station and we suspect a small % of that is replication competent. The second method of sequencing found a SV40 72bp indel that is a nuclear localization signal. That’s likely a bigger deal than the low transformation efficiency.

The sequencing method employed drove this 20-35% figure. Finding a “SV40 72bp indel” suggests that gene expression capability of the plasmid is enhanced i.e. it has greater capability to produce (express) protein or other gene product. mRNA would be one such product. McKernan states:

Circular plasmids like this are used for stable transfection and continued expression of genes in mammalian cells with the strong SV40 promoter. This could lead to prolonged spike expression in patients injected with these constructs.

An unknown portion of these dsDNA contaminants are replication competent plasmids that can transform E.coli with a simple 20 second 42C heat shock treatment… It is unlikely these plasmids will express spike protein in non-laboratory modified E.coli as the ribosomal signals in the vaccine mRNA are designed for mammalian translation. The T7 promoter is known to leak in mammalian cell lines and some laboratory E.coli genotypes but is not expected to leak in wild type E.coli. This may enable mRNA to be expressed from these plasmids in mammalian cells but unless the plasmids are integrated into the human genome, they are unlikely to be replicated to high copy number.

On the one hand, the plasmids are designed to replicate in mammalian cells and therefore unlikely to produce spike protein in bacterial cells that have not been appropriately engineered. By VST’s reading, this suggests that plasmids transfecting gut bacteria will replicate themselves but not trigger spike protein production at that point.

On the other hand, if the plasmids transfect human cells, they may result in the production of mRNA that codes for spike protein. So, by VST’s reading, either mRNA that codes for spike protein could be expressed, or spike protein itself could be expressed. Either way, that’s additional spike protein burden on top of what was actually intended by the shot’s mRNA payload.

But, there’s more.

While bacteria are unlikely to express this spike protein, bacteria can replicate this plasmid and serve as a bactofection source for introduction of these mammalian expression plasmids to human cells.

If the plasmid replicates only itself in the gut bacteria and does not directly express spike protein there in the gut bacteria cells, the host is still burdened with increasing amounts of plasmids that can still transfect the host’s own mammalian cells. A process by which this can be achieved is bactofection:

Bacteria-mediated transfer of plasmid DNA into mammalian cells (bactofection) is a potent approach to express plasmid-encoded heterologous proteins (protein antigens, toxins or enzymes) in a large set of different cell types.

dsDNA’s potential effects inside mammalian cells

Jan 2022 Alden et al “show that BNT162b2 mRNA is reverse transcribed intracellularly into DNA in as fast as 6 h upon BNT162b2 exposure.”. In other words, this study demonstrated that Pfizer’s mRNA payload could, through a process known as LINE-1 Reverse Transcription, integrate with human DNA in human liver cancer cells. That work was done in vitro, and did not directly mean that the result would certainly occur in vivo in normal human liver or other cells.

McKernan’s identification of the plasmid contamination and his re-evaluation of the massive quantity of contamination per shot leads him to suspect that the LINE-1 RT process may not be necessary for the plasmid dsDNA to integrate with human host DNA. Hypothetically, there is so much contaminant dsDNA in the shots that this genetic integration may happen by other means, for example sheer contamination quantity:

The vaccines are providing trillions of dsDNAs… With these levels of contamination, RT activity from LINE-1 is not a prerequisite for genome integration. These data cannot inform on genome integration and further IRB reviewed deep sequencing work is required to address rare mosaic integration events in patients. Regardless of these hypothetical concerns, the dsDNA contamination exceeds the EMA specifications by several orders of magnitude and further scrutiny should be applied to the endotoxin levels and dsRNA levels in these vaccines.

Even if the dsDNA reverse transcription and integration with the human genome does not occur, McKernan flags concerns around potential endotoxin levels in the form of lipopolysaccharides (LPS).

Endotoxins, also called LPS, are the component of the outer membrane of gram-negative bacteria and are released into the circulation upon disruption of the intact bacteria (death, cell lysis). Endotoxin is commonly found everywhere in our environment and it is the most significant pyrogen in parenteral drugs and medical devices. Endotoxins are also present in the digestive system. Their presence in the blood stream may cause septic reactions with a variety of symptoms such as fever, hypotension, nausea, shivering and shock. High concentrations can lead to serious complications such as disseminated intravascular coagulation (DIC), endotoxin shock and adult respiratory distress syndrome (ARDS).

https://www.sciencedirect.com/topics/chemistry/endotoxin

Pyrogens are fever-causing agents. Endotoxin is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria, like E. coli (see image). Endotoxin is a lipopolysaccharide or LPS. LPS [comprises] the lipid A portion… The lipid A portion of LPS is the cause of the molecule’s endotoxin activity. While lipid A does not directly harm any tissue, the immune cells of humans and animals alike see it as an indicator for the presence of bacteria. Thus, these cells stimulate a response that is meant to fend off the unwelcome intruders. An injectable healthcare product such as a vaccine or intravenous solution must be sterile or free of live bacteria, but the manufacturing process to kill any bacteria can result in release of LPS or endotoxin into the product. Just as with a bacterial infection or sepsis, if sufficient endotoxin gets into our blood stream or spinal fluid we can develop fever, shock, and organ failure. In extreme cases, it can even result in death.

https://www.horseshoecrab.org/med/endotoxin.html

EDIT via Kevin McKernan:

The presence of E.coli based plasmids is a canary for Lipopolysaccharide (LPS or endotoxin) contamination. Whenever you see high levels of plasmid contamination derived from gram negative bacteria like E.coli, you should expect high levels of endotoxin contamination. Injecting endotoxin can lead to anaphylaxis and toxic shock syndrome.

McKernan’s concern about endotoxins stems from the use of gram negative bacteria E. coli in the manufacturing process. He assumes that because the plasmid contamination is present, the LPS endotoxin is likely to be present as well:

I should clarify where I think the LPS is coming from. Pharma uses these plasmids to brew up lots of E.coli that amplify the plasmids. They have to purify these plasmids out of the e.coli and that process is prone to LPS contamination.

VST’s understanding, with clarification direct from McKernan, is that given the level of plasmid contamination, the potential for associated attendant LPS contamination warrants further investigation given its potential toxicity.

To sum up:

• 20-35% of the shot contents is dsDNA plasmid contaminant that is replication competent in human and bacterial cells.

• The plasmids, through multiple means including possible integration with human DNA, could effectively extend host spike production in the body for an indeterminate and unintended length of time.

• The plasmid’s antibiotic resistance makes it hard to remove from the gut and could exacerbate general antibiotic resistance in humans to neomycin and kanamycin.

• The levels of contaminant exceed EMA limits.

• The EMA was aware of the contaminant risk and set limits, although why and how is unclear. This means the EMA was aware of potential dsDNA presence and risk before the gene therapies were in widespread use.

• The plasmids have the effect of turning the human host into a breeding ground for plasmids and, in turn, mRNA that may contain the spike coding, thereby adding to the overall spike protein burden.

• Edit: The presence of the plasmids suggests that endotoxin LPS levels should be investigated due to the potential for poisoning that can be harmful or fatal.

• These phenomenon raise serious questions of the overall manufacturing QC, QA, and regulatory oversight process, globally.

• The sheer volume of contamination could drive host genome integration of dsDNA with unknown effects over unknown timeframes.

Complex corollaries and systemic effects

McKernan’s research gives us a glimpse of the incredibly complex, systemic effects of the Covid gene therapies. In the context of the scale, speed and justification for the global rollout, this beggars belief. Furthermore, this work is being done privately and independently, with no support from regulators or manufacturers, and has not been done before. This means that there is either the wilful neglect of these areas of systemic research into genetic treatments or a wilful tolerance of or even intent to deploy products with known and unknown genetic effects on the human race. Again, this is yet another example of the potentially monumental failures of the Covid gene therapy development and roll out process.

As McKernan states, these products and these identified issues have been injected into children. mRNA payload has now been detected in breastmilk and blood, meaning that it is potentially transferrable via breastfeeding (see claims that the products are safe and effective for women) and via blood transfusion.

We also need to determine whether the mRNA, contaminants and spike protein are present in any bodily secretion, any of which would constitute what is crudely referred to in lay circles as “shedding” of some form. If such phenomena are detected at significant levels such that transfer of any of the materials can confer an effect on the recipient, this would be another example of undeclared effects on the population in general. In extremis, this could even constitute evidence of what has been called a “self spreading vaccine”.

It doesn’t end there

The implications of McKernan’s research doesn’t end here. There’s more to be considered. Let’s think about what was expected and communicated about these products from the point of view of patients.

The expected content of Pfizer’s monovalent Covid gene therapy

We’ll focus on the UK’s MHRA regulatory regime for Pfizer and documentation therein to illustrate the expected and communicated ingredients of the Covid gene therapy.

The supposed ingredients of Pfizer’s monovalent Covid gene therapy can be found in multiple places, including:

1. manufacturer regulatory submissions e. trial documentation;

2. manufacturer supply contracts.

3. regulatory analysis and approval documentation e.g. EUAs or CMAs*;

4. manufacturer package inserts*;

5. regulator patient information leaflets*;

*These documents are, by definition, publicly available.

As is shown in the Pfizer FDA FOIA case, manufacturer regulatory submissions are not public. Manufacturers retain full commercial ownership over all clinical trial data and can potentially withhold various forms of data from the regulators, who are dependent upon the manufacturer to answer questions to the point that the regulator’s curiosity on a given matter is satisfied. An example of data withheld includes the Pfizer Biodistribution study. This was requested by the Japanese regulator but not by US, UK and European regulators.

Supply contracts are completely confidential but some have been partially leaked.

Here’s the MHRA’s main page for Regulatory approval of Pfizer/BioNTech vaccine for COVID-19.

Here is an archived version of “Package leaflet: Information for the recipient COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection tozinameran” listed last updated 12/2021. It states:

What COVID-19 mRNA Vaccine BNT162b2 contains

The active substance is tozinameran.

After dilution, the vial contains 6 doses, of 0.3 mL with 30 micrograms tozinameran each.

This vaccine contains polyethylene glycol/macrogol (PEG) as part of ALC-0159

The other ingredients are:

• ALC-0315 = (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate),

• ALC-0159 = 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, - 1,2-Distearoyl-sn-glycero-3-phosphocholine,

• cholesterol,

• potassium chloride,

• potassium dihydrogen phosphate,

• sodium chloride,

• disodium hydrogen phosphate dihydrate,

• sucrose

• water for injections

This ingredients list specifies the proprietary ingredients tozinameran, ALC-0315 and ALC-0159. Tozinameran is the proprietary name for the mRNA payload that contains the spike protein coding instructions that are delivered to the patient’s ribosomes. ALC-031 and 0159 are components of the synthetic Lipid Nanoparticle wrapper that protects the tozinameran payload and enable transfection.

No other ingredients are implied anywhere in this patient information leaflet. No quality control specifications are indicated, including the possibility or tolerance of contamination of any kind.

The MHRA’s Information for Healthcare Professionals on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174) contains the same ingredients list (“6.1 List of Excipients”) and the following:

Tozinameran is highly purified single-stranded, 5’-capped messenger RNA (mRNA) produced by cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.

But again, this document does not mention any possibility of contamination or additional genetic material.

The MHRA’s Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection lists and describes the above ingredients. In section II.2 ACTIVE SUBSTANCE, specific verbiage covers tozinameran and aspects of its manufacture (my bold):

…Overall, production of the active substance from the designated starting materials has been adequately described and appropriate in-process controls and adequate starting material specifications are applied.

The starting materials are adenosine triphosphate, cytidine triphosphate, guanosine triphosphate, modified uridine triphosphate, 5’ Cap and the DNA template from which the RNA is transcribed. The DNA template from which the RNA is transcribed is critical for the fidelity of the mRNA.

The manufacture of the DNA template has been described. It is manufactured through fermentation in an established and well-controlled Escherichia coli cell line, extracted and purified. The specifications controlling the quality of the DNA template are satisfactory. Batch data for the DNA template have been supplied for several batches for which an acceptable level of batch to batch consistency is observed. The genealogy of the finished product can be traced back to the batch of originating DNA template. The in vitro enzymatic RNA transcription process has been adequately described. The 5’cap and poly(A) tail are co-transcribed with the S1S2 spike protein codon.

It is noted that the operating parameters for this process span a wide range however this does not raise any immediate concerns for the batch under review. Full scale validation data for RNA transcription demonstrates consistency and repeatability of the process operation and is accepted as qualifying the process operated at its target set points. The manufacturer has performed a comparability assessment of drug substance batches used in the clinical trial programme and batches representative of the subsequent manufacturing changes occurring during product development, such as introduction of new manufacturing sites, manufacturing process changes and increase in batch scale, including full scale validation batches.

The drug substance batch release data for essential parameters that control the quality of the active RNA and several extended characterisation test parameters were considered. These data demonstrate consistency between the drug substance described for this application and those used in the pivotal clinical study. Analytical procedure methods have been described and are considered appropriately qualified to control this batch in the context of a batch specific approval.

The shelf-life for BNT162b2 RNA (drug substance) has been provided and is satisfactory in relation to the cadence of drug substance to drug product manufacture.

As highlighted, the mRNA active ingredient of the Comirnaty gene therapy comes from the production of a DNA template that is grown inside an E. Coli strain, from which the desired mRNA is derived, extracted and purified. This entire section implies that nothing but the desired active substance is taken from this manufacturing process.

Let us assume that the MHRA’s end-to-end regulation of design, manufacture, and deployment of the product adequately controls Pfizer's processes (despite McKernan’s findings to the contrary).

Pfizer Supply Contracts

VST wrote about the leaked Brazilian Pfizer supply contract here. The head of Pfizer Brazil testified that the supply contract terms were common across 110 countries. Although that leaked supply contract is clearly only one of multiple documents (Specifications being mentioned and likely of great interest and relevance to this article), it still provides insight into the restrictions under which the MHRA’s regulatory activity takes place.

Within the scope of this contract, Pfizer only warranted that “at the time of delivery, the Product complies in a material manner with the relevant Specifications”. In the absence of the detail of the Specifications, the express acceptance of a product with unknown efficacy means it could be possible that Pfizer is only contracted to supply a product made of the specified ingredients in a specified way (Good Manufacturing Process) that meets the Specification, but has no specified performance. On the other hand, the Specification could have contained performance criteria tied to trial results around efficacy, for example. Without the Specification we won't know.

Brazil has only 24 hours from time of receipt to exercise its ability to reject detectably defective product. This requires that Brazil has the ability to identify defects of any kind in that timeframe. What if some of those defects only manifest once administered in a subject? Therefore if Brazil can really only reject product on its limited ability to find product defects prior to administration within 24 hours e.g. damaged packaging, identifiable ingredient or consistency problems, cold chain breaches etc, this right to reject is extremely constrained.

Assuming the same terms apply to the UK for a given batch, the MHRA has 24 hours from formal receipt to inspect any aspect of the product and identify shortcomings. In the case of the content, the MHRA would have to have greater knowledge and specifications of the composition of the product, including genetic information, than is linked in the referenced documents above to be able to sequence and analyse batch samples against a detailed specification that is not described in the MHRA EPAR document. The regulator would need to be inspecting vial content in a manner similar to McKernan in order to detect dsDNA contamination.

Regulatory and medical context affecting patient informed consent

McKernan’s first paper Deep sequencing of the Moderna and Pfizer bivalent vaccines identifies contamination of expression vectors designed for plasmid amplification in bacteria contains an extensive overview of fundamental and compounding issues in the safety and efficacy of the Covid gene therapies. A lay summary follows.

First, McKernan lays out the current state of play with the Covid gene therapies.

1. Despite regulatory authorisation of the gene therapies, the EMA and TGA found evidence of manufacturing and quality flaws, described as “fidelity problems”. Note, the MHRA stated “The DNA template from which the RNA is transcribed is critical for the fidelity of the mRNA”. This is a reference to the expression vectors (plasmids).

2. McKernan points out that it is impossible for a patient to give adequately informed consent if the treatment is “poorly characterized” i.e. its ingredients, quality, positive and/or negative effects and overall risk benefit are improperly understood and explained. Per the MHRA’s own documentation, if the treatment doesn’t work as advertised, contains undeclared ingredients (or contaminants) or confers undisclosed risks, informed consent goes out the window.

3. The association of hitherto undeclared risk of myocarditis and pericarditis are examples of undisclosed risk affecting the overall safety and efficacy of the treatment. Many patients took these products with no knowledge of the myocarditis/pericarditis risks. Their decision making would have been impacted by this, had they known beforehand.

4. Negative effects of the treatment may be exacerbated by its delivery method, notably the widespread practise of unaspirated injection that increases the risk of unintended and undesirable intravenous injection into a blood vessel.

5. These risks must be accurately weighed against those presented by the virus and the infection, which is shown to be below an infection fatality rate of 0.5% based on published infection and death numbers using questionable official data.

6. Natural immunity that results from recovery from infection is known and admitted to being more effective than any immunity conferred by the treatment.

7. The kind of immunity the treatment confers must be considered. These treatments follow a narrow-epitope strategy i.e. they trigger an immune response that focuses on just a highly specific part (an antigen) of the virus, of which an epitope is a subunit of the larger antigen.

8. A narrow-epitope strategy results in the virus easily mutating such that subsequent variants evade the narrow and highly specific immune response, leaving the patient vulnerable to further infection by new variants. Boosters do nothing to address this, especially since boosters are not reformulated and patients have received multiple same-formulation boosters so far.

9. Ongoing analysis suggests that patient’s overall immune system capability is actually being degraded. The patient is being effectively coerced into a cycle of taking more boosters to compensate, erroneously, for this treatment-induced degradation. Thus, the patient enters a positive feedback cycle where their overall immune system capability continues to be further degraded. This totally undermines informed consent because they are being told to take more treatment under false pretences e.g.:

   1. “Australia is now 96% vaccinated (16+ 2 Doses) and the hospitals are enriched above 96% for vaccinated patients. Excess mortality in Australia is higher post vaccination than during the pre-vaccination pandemic.”

10. Pfizer, for example, has wilfully misrepresented its treatment’s Risk Reduction by presenting Relative Risk Reduction instead of Absolute Risk Reduction, thereby violating FDA policy.

11. Quality control is seriously inadequate, to the point that McKernan states the fidelity of these treatments has not been proven. This is a fundamental problem given that the treatment design and manufacturing process is error prone. The sheer number of mRNA particles that are delivered in a single dose means that the amount of faulty (fragmented) mRNA particles can be huge and confer practically unknown risks, before one accounts for the dsDNA contaminant that McKernan states exceeds EMA limits by orders of magnitude.

12. Because quality/fidelity assurance of the treatments are inadequate, there are ambiguities about what exactly patients are being injected with. It cannot be assumed that malformed mRNA is absent or present in harmless quantities, and no safety testing around the effects of erroneous or contaminant genetic material has been conducted.

This is one massive unexploded bombshell

Take everything you’ve read here, take a step back and a deep breath.

Pending certain confirmation of McKernan’s work, here’s the simplest way of summarising what we are looking at:

Patients have literally no idea what they were injected with, what it will actually do to them over any time frame, and why they were allowed to be placed in this position.

Under these circumstances and against the regulators’ own patient information, the guidance given to patients and the claims made about safety and efficacy, patient informed consent could not really have existed.

There are two very simple reasons why this could be the case:

1. The regulators did not know what was actually in the production batches of the monovalent or bivalent shots because they did not perform any kind of effective analysis on them.

2. They knew what was in the shots and did nothing.

In both cases, the regulators and everyone operating under their authority peddled the lie that the shots only contained the ingredients listed in the regulatory and manufacturer information, and falsely claimed that the shots were safe and effective.

In light of McKernan’s work, the only thing that can be said that would be true is “we don’t know if the shots are safe, and our claims of efficacy are shown to be untrue by data that was produced in the phase 3 clinical trial and since.”