LETTER: RNA & DNA Contamination in Covid Gene Therapies & LNP Placenta Barrier #plasmidgate #placentagate

Please use this letter in your neworks and audiences

The following letter has been drafted for use with any media or relevant audience that you, readers of this blog, feel should know about the issues contained within #plasmidgate and #placentagate.

PLEASE consider taking this letter and sending it to literally anyone you feel could benefit from its contents and/or act on it in any way to raise awareness, publicise, drive support to Kevin McKernan’s peer review, Sasha Latypova’s work or the European contaminant research, or Jikkyleak’s identification of possible fraud re safety and efficacy claims around LNPs and Covid gene therapies and fertility.

This situation requires that individuals do individual things that add up to meaningful collective action. That includes you using resources like this with any audience. Please act.

VST has begun sending this out but your involvement and networks are requested to demand answers through the force of increasing publicity and awareness.

Make no mistake, #plasmidgate and #placentagate could represent the largest, most egregious medical and scientific malpractice in the history of mankind, with unknown consequences on the human race. These are genetic medicines and we don’t know what’s in them or what they do, despite what we’ve been told.

---

Dear [NAME],

I write to draw your attention to two areas of major concern regarding Covid gene therapies. My hope is that you will examine these lines of inquiry. These issues comprise:

• RNA, DNA contamination of Covid gene therapies, detected by two independent lines of research, one ongoing #plasmidgate;

• The implications of the contamination on regulator activity and competence, and for patients and their informed consent;

• The scientific evidence of Lipid NanoParticle capability (inherently or by design) to get to and across the placental barrier, with demonstrable deleterious effects #placentagate;

• The potential meaning and outcome of combining all of the above in humans who have been injected with Covid gene therapies.

I stress what follows, while seemingly complex science, is absolutely fundamental to the work of all medical regulators in ICMRA and beyond. That the following exists and has been detected by two independent researchers is a potentially damning indictment of regulatory capability and regulators need to be made to investigate, address these issues and explain exactly how the situation arose. Provided McKernan's work can be backed up and confirmed, regulators must prove that genetic contamination is not present in Covid gene therapies. If they cannot, they must explain why these phenomena exist and how, then explain what the upstream causal factors are and the downstream implications are. Anything less is a dereliction of duty.

You should come to understand that the presence of these issues, if multiply confirmed, means that the regulators must either be knowingly allowing these products to contain variable and unspecified ingredients/contaminants, or they do not know because they are not monitoring, at the very least, the final production gene therapies before they were injected into citizens. 

Further, everything that follows comprises clear non-conformance to published regulatory specifications for the Covid gene therapies. This means, at the simple, base level, that the regulators’ published information (EUA/CMA/EPAR, info for health professionals, patient information leaflets) is inaccurate and therefore patients have been misinformed about what they have been injected with and the effects it should and could have on them.

#Plasmidgate - DNA, RNA & Protein Contamination in Covid Gene Therapies

In 2021, Sasha Latypova, Pharma & Medical Device R&D Senior Executive, performed VAERS analysis and "found in early 2021 from looking at VAERS adverse events by lot number - the manufacturing of the vials is “changed on the fly” and nobody is checking or enforcing any cGMP standards:". Latypova was provided with European research that separated RNA, DNA and protein from Covid gene therapy vials. RNA in the Pfizer vial did not conform to Pfizer's declared specifications; either too long or too short (fragmented) in nucleic acid sequence length. This research also detected the presence of DNA contamination that was orders of magnitude above regulator limits, and protein contamination.  According to her findings in regulatory documentation, regulators were aware of non-conformances but allowed it. RNA fragments can have toxic and carcinogenic effects. This research did not sequence the DNA found, so what it was was unknown.

Since February 2023, Kevin McKernan, expert in genomics and sequencing, is engaged in independent and ongoing analysis of vial content of the Moderna and Pfizer monovalent and bivalent gene therapies. He found RNA and DNA contamination that was again out of specification. He has used 9 different tests (assays) to characterise the contamination. In summary:

• All gene therapies contain RNA that is out of spec (both longer and fragments).

• The DNA contamination comprises "expression vector plasmids", which are remnants of the gene therapy manufacturing process, and are genetically active i.e. they are "replication competent" in mammalian and bacterial cells, capable of producing copies of themselves in vivo, with unknown but hypothetical effects.

• The amount of this contamination is "orders of magnitude" above specific limits set by the EMA ("dsDNA contamination levels are 100 fold higher and imply trillions of DNA molecules per dose.").

• The EMA had a prior appreciation of the need to set limits on DNA contamination, although why and how those limits were set for these products is not stated in documentation Latypova or McKernan have seen. This demonstrates regulatory concern about such contamination that precedes product roll out.

• These plasmids are made of double strand DNA (dsDNA). Injecting dsDNA into humans (in a DNA vaccine, for example) is known to produce a human immune Type 1 Interferon response via STING. This means that regardless of why the contamination is there, some form of undocumented immune response could be triggered in patients by the dsDNA alone.

• The plasmids have been engineered with specific characteristics including coding for spike protein and antibiotic resistance to neomycin and kanamycin.

• The plasmids contain genetic code for SV40 promoter, with some being engineered with that code occurring twice. SV40 promoter makes the plasmid more capable of gene expression i.e. producing proteins that have some effect, and doubling SV40 increases gene expression capability further.

• The detected "SV40 promoter with 72bps indel" is a "nuclear localization signal" that means either the plasmid or one of its expressed proteins can be transported into host cell nuclei, where the host DNA is found, creating an open question of whether host DNA interaction will occur and to what effect e.g. integration with human DNA.

• The plasmids also contain the genetic code for spike protein. Combine the plasmid's capability to express spike protein with one or two SV40 promoters, and that could be a powerful source of spike protein production in vivo additional to that intended by the gene therapy's in-spec mRNA payload, in a totally uncontrolled way for unknown duration.

Potential effects of plasmid contamination in vivo

• Simply injecting humans with dsDNA could trigger the inherent, unintended STING immune response involving cytokines, to unknown degree given the level of dsDNA contamination.

• Out-of-spec mRNA contamination could have unknown effect, possibly carcinogenic based on prior knowledge of mRNA and micro RNA (miRNA).

• The LNP component of the gene therapies has the potential to encapsulate the dsDNA contamination just like it is intended to encapsulate the mRNA payload. If this happens, dsDNA contamination would be delivered in vivo in the same way as the mRNA payload i.e.  hidden from the immune system, throughout the entire body, into cells where they can replicate and interact at the nuclear level i.e. with access to the human genome.

• Manufacturer animal biodistribution studies show that the LNPs can get literally anywhere in the body, thereby delivering their payload (mRNA or dsDNA) to cells of all tissue types, including into the intestine, where gut microbiome bacteria reside.

• Should the dsDNA plasmids access gut bacteria, they are capable of entering (transfecting) those bacteria and potentially replicating 50 - 300 copies of themselves in the gut.

• The plasmids are antibiotic resistant, with unknown effect. There is an open question of whether they could contribute to general antibiotic resistance in humans, globally.

• The plasmids can transfect human cells via delivery while encapsulated in LNP wrappers or possibly by virtue of their massive number having replicated in bacteria, leading to bactofection, wherein some of the body's cells try to kill plasmid-infected bacteria by engulfing them. This process can result in plasmids transfecting the human cells that engulfed the bacteria.

• All of the above, combined with the plasmid's capability to code for spike protein, possibly enhanced by the SV40 promoter, means that in vivo spike protein production could be significantly increased in quantity and extended in duration, well outside of any originally intended limits. Research has demonstrated in vivo spike production continuing for over six weeks and possibly months.

• The plasmids have the potential to enter the nucleus of human cells and integrate with human DNA. It has been experimentally shown in vitro that the mRNA payload can do this in human liver cancer cells via a process called LINE-1 reverse transcription. That experiment does not necessarily mean it will happen in vivo in other non-cancer human cells, but that research warrants further studies. However, McKernan points out that when dsDNA contamination is present in sufficiently large quantity, it can potentially integrate with human DNA by sheer force of contamination i.e. without the LINE-1 RT process being employed, which gives rise to the question of whether this is happening in humans and to what effects.

Possible endotoxin presence

All of the above, in McKernan's view, is a result of the manufacturing process that employ engineered E. coli bacteria in which the dsDNA plasmids are grown. The plasmids are a DNA template from which the mRNA active ingredients of the Covid gene therapies are derived. Thus, the quality ("fidelity") of the plasmids are fundamental to the quality of the mRNA payload (paraphrasing MHRA). The production process should extract the plasmids from the E. Coli bacteria, derive the mRNA payload and then purify the mRNA.

What he has detected is production plasmids from the manufacturing process that have not been removed, suggesting inadequate purification. It is his natural and informed suspicion that the presence of plasmids suggests the hypothetical  presence of another related substance that inherently occurs as a result of extracting plasmids from a gram negative bacteria such as E. coli. When such bacteria are destroyed - say in the act of plasmid extraction - an endotoxin, lipopolysaccharide (LPS), is released. LPS, when injected into humans, can cause significant deleterious effects including anaphylaxis and can therefore be harmful or fatal.

That the plasmid contamination is present is a flag for possible LPS contamination, and in McKernan's view this also needs to be properly investigated. At worst, Covid gene therapies could contain LPS at levels that alone causes harm or possible death. Numerous documented cases of anaphylaxis have been recorded and anaphylaxis is formally recognised as being caused in some people by the Covid gene therapies. Hypothetically, it could be that some batches that triggered anaphylaxis did so in whole or part because of LPS levels.

QC, QA, oversight and monitoring

All of the above begs questions of the entire, global Quality Control, Quality Assurance, regulatory oversight and monitoring of the Covid gene therapies. In short, if these processes were in place effectively, then products that contained anything other than the ingredients specified in regulatory and manufacturer patient information and package inserts would not be released to the market and injected into humans.

Misinformed patients, informed consent and liability

Patients have not been told about the possible presence of contamination or ingredients other than listed in information provided to them, nor have the possible effects of such been explained. The risks and probabilities of this have not been explained. Thus, patient informed consent may have been impacted to the extent that true informed consent could never have been given.

If regulators knew of possible contamination with genetic material and set limits for it, conformant presence of such material could be considered "an ingredient", which could, even in limited amounts, have some effect on the patient. No such possible genetic contaminant was declared on the regulatory or manufacturer patient information, and no side-effects or risks associated were expressly listed beyond side-effects associated with the declared ingredients. From documentation currently available, it would appear that clinical trials of the products did not include researching the effects of mRNA, miRNA or dsDNA contamination on humans specifically, even though it was a concern known to the regulators, who took specific decisions around limits, but appear to have failed to police those limits.

Thus, there are questions about liability that flow from the manufacturer, through governments to the regulator and any of its agents, including doctors, nurses and vaccinator staff.

Infant and child exposure

The products investigated in the above manner have been used to inject infants and children. That there is a possibility of their exposure to this contaminant should be cause for great concern. 

#Placentagate

The general claim of manufacturers, governments and regulators has been that the Covid gene therapies are safe and effective for women, pregnant or otherwise, and infants and children. This claim has been made despite a lack of evidence proving the claim. Lack of evidence of harm due to no clinical trials or investigation into potential or actual harm is not proof of safety i.e. absence of evidence is not evidence of absence.

It has been scientifically demonstrated in Pfizer animal studies that LNPs employed in Covid gene therapies biodistribute throughout the entire body and all investigated cell types, accreting over the observed 48-hour time period. Notably, this accretion occurred in the brain, liver and ovaries. The ovarian accretion was very high. The ovary is not designed to remove contaminants.

Other research has shown that LNPs not necessarily of the specific type employed in Covid gene therapies have the ability, either innately or by design, to get to and through the placenta and placental barrier and into trophoblasts, for the express delivery of mRNA payloads there. These structures are inherently fundamental to embryo implantation and development. It may be the case that Covid gene therapy LNPs have this innate or deliberate placental affinity. The accretion of them in the ovary and designed capability to transfect all human cells makes this a possibility. Some research claims this LNP mRNA delivery has been done with "no toxicity" but this claim has been called into question by @Jikkyleaks, an anonymous scientist involved in close scrutiny of scientific matters across the pandemic. Jikkyleak's investigation into LNP research and claims, as they relate to fertility, are encapsulated within #Placentagate (see article below for lay primer and further links) and reveal potential deliberate obfuscation of evidence refuting the "no toxicity" claim in the very research papers making that claim.

Further Jikkyleaks demonstrates that agents within the scientific community who constitute "pharma's go-to on fertility" have nepotistic links and vested interests amongst each other and traceable funding and publishing relationships that all add up to potential conflicts of and vested interests.

This situation alone begs the question of what effect the LNPs and intended mRNA payload in Covid gene therapies has on women, pregnancy, embryos, foetuses and children. Literally no human research on these specific questions was done prior to the roll out, and this is expressly stated by regulators in public documentation. Phase 3 clinical trials into aspects of these areas of enquiry were only initiated well after roll out had begun. By their nature, human fertility testing takes more than a decade if it seeks to look at the longitudinal effect on both first and second generation offspring.

Now consider the possible questions around LNPs carrying unintended and unstudied out-of-specification mRNA, miRNA and dsDNA to the the ovary, the placenta, the embryo and foetus.

Combine #Plasmidgate with #Placentagate

If we now consider the integration of all of the above, we are faced with numerous possibilities and unanswered questions around the net effect on humans and their offspring, of the Covid gene therapies.

What is warranted by the above?

I suggest that the issues described here warrant:

• urgent further experimental investigation into the content of production vials of all Covid gene therapies to verify McKernan et al's findings. McKernan seeks precisely greater involvement and active peer review of his work. He has made fully available, for low cost, all the means to independently verify his work.

• publicity of his work to make the population aware in order to drive public demand for answers to the questions raised.

• direct challenge of all global medical regulators and pharma manufacturers in order to demand answers to the myriad questions and proof supporting all answers.

What you can do

Please consider:

• examining the above yourself and, should you feel the above is valid, using your platform to inform your audiences of the concerns raised, implications and calls for action.

• contacting Kevin McKernan and Sasha Latypova directly, with a view to giving either or both a chance to provide an in-depth, lay accessible explanation of all of the above.

• factoring the above into your work on medical regulators' and manufacturers' roles in Covid and the Covid gene therapies, specifically challenging them with the above and demanding answers.

• consider activating your audiences around the above to directly pressure manufacturers and regulators for answers.

These issues represent potentially the most egregious shortcomings in medicine in the history of mankind precisely because the products are genetic in nature, have the hitherto undisclosed ability to biodistribute throughout the body, and have the potential for unknown, complex effects. That genetic contamination of the kind described above has been detected in such scale amplifies all of these issues by potential orders of magnitude.

For an hour long conversation between Jessica Rose and Kevin McKernan on this topic, which provides a relatively easy start point, see this interview:

https://rumble.com/v2ekgwu-contamination-of-mrna-covid-products.html

For further detailed information and access to full sourcing of all of the issues described herein, please start with the following articles which were written for lay audiences.

https://veryslowthinking.substack.com/p/mckernan-dna-contamination-in-covid

https://veryslowthinking.substack.com/p/latypova-dna-contamination-in-shots

https://veryslowthinking.substack.com/p/placentagate

Contacts

@kevin_mckernan

Kevin.McKernan at medicinalgenomics.com
https://anandamide.substack.com/

Sasha Latypova

https://sashalatypova.substack.com/p/kevin-mckernan-reports-on-plasmidgate?autoPlay=true

@sasha_latypova

@jikkyleaks