GMOs

Australian GP Sues Pfizer and Moderna Over Unapproved GMOs in mRNA Covid vaccines

1 August 2023

4.7 MINS

The human genome could be permanently altered.

A Victorian doctor and pharmacist is seeking an injunction from the Federal Court of Australia to stop Pfizer and Moderna from distributing their mRNA Covid vaccines.

Dr Julian Fidge alleges that both the monovalent and bivalent vaccines contain genetically modified organisms (GMOs), for which Pfizer and Moderna did not obtain the appropriate licence.

It is a serious criminal offence under the Gene Technology Act 2000 to sell or distribute GMO products in Australia without approval from the Office of the Gene Technology Regulator (OGTR). However, Pfizer and Moderna only sought approvals for their Covid vaccine products from the Therapeutic Goods Administration (TGA), which is not authorised to approve GMO products in Australia.

The TGA did not require tests for genotoxicity or carcinogenicity before providing provisional approval and, in the case of Moderna’s SPIKEVAX, full registration. These tests would be required for GMO product approval by the OGTR.

This has significant safety implications, says legal counsel on the court case, Julian Gillespie.

“By failing to apply for the appropriate licences from the Office of the Gene Technology Regulator, Pfizer and Moderna avoided very serious risk assessment questions and processes that are necessary to determine the safety of these products.”

GMO products, not normal vaccines

The case, which is the first of its kind in Australia, argues that there are not one, but two GMO components in the mRNA Covid vaccines.

The first is the LNP-mRNA complexes. Remember the talk about the synthetic (modified) mRNA being delivered in lipid nanoparticles, and how this was one of the major technological advances that enabled the development of these vaccines? That’s what we’re referring to here.

The case argues that decades of scientific research show that LNP-mRNA complexes are GMOs that have the capacity to integrate into the human genome.

The second GMO component named in the case is synthetic DNA contamination.

In tests conducted on the mRNA monovalents and bivalents, genomics expert Kevin McKernan found dangerously excessive levels of DNA contamination — anywhere between 18-70 times above legal limits. McKernan’s findings are now being verified by other scientists.

Says instructing solicitor, Katie Ashby-Koppens of PJ O’Brien & Associates,

“The case is super simple. These products are GMOs by mechanism, and by contamination.”

Human genome could be permanently altered

The GMO nature of the LNP-modRNA complexes, coupled with McKernan’s findings of DNA contamination in the mRNA Covid vaccines, may have profound consequences, for Australia and for the world.

There is already at least one peer-reviewed scientific paper demonstrating that the Pfizer Covid vaccine mRNA is able to enter the human liver cell line and reverse transcribe into DNA in vitro (meaning in a lab dish).

Additional studies are cited in the case materials showing the presence of Covid vaccine mRNA in the nucleus of human cells, and evidence that acquired immune traits pass down to the offspring of mice pre-exposed to the Covid vaccine mRNA-LNP platform. This is suggestive that, once in the nucleus, the vaccine mRNA can be transferred and integrated with chromosomal DNA.

“Every single person who has been injected with these products has received a GMO that has not been through the expert regulatory process in this country,” says Ashby-Koppens. “The human genome could be changed permanently, and no one was informed.”

mRNA Covid-19 vaccines should never have been approved

Like most Australians, Dr Fidge, who is 60 years old, rolled up his sleeve when the Covid vaccines first became available.

“I’ve been vaccinated with these mRNA Covid-19 vaccines, and I’ve vaccinated thousands of patients, including my own children,” says Dr Fidge, who currently practices as a GP in Wangaratta. “But I have since become very concerned about the unregulated GMOs in these products, especially in the form of synthetic DNA contamination.”

Now, Dr Fidge says his children won’t be receiving any more doses of the vaccines. “I think the Therapeutic Goods Administration has made a terrible mistake in approving the mRNA Covid-19 vaccines, particularly for use in children,” says Dr Fidge.

“I hope that the mRNA Covid-19 vaccines will be suspended immediately until they’ve been assessed by the Office of the Gene Technology Regulator.”

Regulators failed to act

Dr Fidge and the legal team believe that Moderna and Pfizer knew that their products contained GMOs. Moreover, the regulators were both notified of the GMO content in 2022, but did not take action.

“We took this case on because neither of the appropriate regulators were doing anything about it,” says Ashby-Koppens.

“The Therapeutic Goods Administration and Office of the Gene Technology Regulator were both put on notice in 2022 that these products contain GMOs and they have failed to act. It has been left to citizens to do what the Australian Government won’t do.”

The case notes that AstraZeneca did seek a GMO license from the OGTR prior to seeking provisional approval from the TGA for its Vaxzevria product.

Gillespie, who has just published a peer-reviewed paper titled The Canaries in the Human DNA Mine, says,

“There is forty years of established science in this area, where we must now unfortunately assume the DNA of Australians receiving these drugs has been permanently altered and also that of their offspring.

“This is devastating and will have far-reaching adverse health consequences never before seen. This is exactly what the Gene Technology Act 2000 was put in place to prevent.”

Medical professionals call for investigation

The Australian Medical Professionals Society (AMPS) is now calling for Australia’s medical and scientific colleges and associations to investigate the allegations of unapproved GMOs in Pfizer and Moderna’s mRNA Covid vaccines.

In January of this year, Cardiologist and President of AMPS, Dr Christopher Neil, wrote to the Secretary of the Department of Health, Professor Brendan Murphy, raising concerns about the potential for mRNA from Covid vaccines to be reverse transcribed.

The letter referenced the aforementioned study in which Swedish researchers demonstrated in vitro reverse transcription of the Pfizer Covid vaccine mRNA into DNA.

Prof Murphy dismissed these concerns, replying,

“You have… incorrectly stated that mRNA vaccines are gene therapies — they are not under the legislative framework which governs the TGA and OGTR. mRNA vaccines do not enter the cell nucleus or interact with DNA and it is misleading to characterise them in this way.”

GMOs

Letter to AMPS from Prof Brendan Murphy, Secretary of the Department of Health, 16 Jan 2023

However, Prof Murphy provided no supporting documentation for this claim, nor did he include a rebuttal of the findings in the study referenced by AMPS.

Dr Neil says that in light of the precautionary principle and the medical maxim of ‘first do no harm’, the GMO allegations cannot be ignored and must be investigated.

“Our members view this as the minimum due diligence required in order to comply with both the spirit and the letter of the law,” says Dr Neil.

“Health professionals and scientists alike have ethical and professional responsibilities to inform the public when agencies of the State have possibly fallen into error, and those errors place at risk the health and lives of the population, and that of future generations.

“If these allegations are true, this is unprecedented and represents a clear and present threat to the integrity of human DNA everywhere these products have been deployed.”

___

Originally published at Dystopian Down Under. Photo by Daniel Dan.

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2 Comments

  1. Stephen Lewin 1 August 2023 at 9:21 am - Reply

    Thanks Rebekah for a very very informative article which contains research and observations that deserves a full response from authorities

  2. Kim Beazley 1 August 2023 at 3:29 pm - Reply

    There is so much in this article (which I’ve found is not much more than a cut and paste from other articles available online) which is not as it seems.

    The first is the actual claim by Dr Fidge in the case against Pfizer and Moderna, on the basis that the mRNA particle within the lipid nanoparticle, the active ingredient in the vaccine, is really a GMO (Genetically Modified Organism). But it is nothing of the sort.

    The case is being raised on the basis that, as a GMO, Pfizer and Moderna have breached the Gene Technology Act 2000. But when you read what the Act says (http://classic.austlii.edu.au/au/legis/cth/consol_act/gta2000162/s10.html#environment), you see it’s no such thing, as a GMO is defined as:

    ” (a) an organism that has been modified by gene technology; or

    (b) an organism that has inherited particular traits from an organism (the initial organism ), being traits that occurred in the initial organism because of gene technology; or

    (c) anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms”

    As the spike protein is NOT an organism by any definition of the word, then what this doctor is committing is a category error. It’s apples and oranges. In fact, the article itself gives the correct definition: “synthetic (modified) mRNA being delivered in lipid nanoparticles”. If it is “synthetic” and “modified”, how can it possibly be classified as an organism?

    And we cannot rule out the possibility that he’s knowingly equivocating in the hope that a judge or magistrate doesn’t understand the difference.

    Coincidentally, I went for my annual skin check today, and my skin specialist, who originally trained as an immunologist, when I told her about this GMO claim, she looked at me quizzically, and then laughed!

    But it’s after the “GMO” claim that we find the real purpose of the case, which arises from the highly dubious and thoroughly refuted claim of Dr Kevin McKernan that the mRNA vaccines may alter our DNA and cause cancer.

    But Dr David Gorski, at https://www.respectfulinsolence.com/2023/06/06/return-of-the-revenge-of-vaccines-permanently-alter-your-dna/ goes into great detail in a very long article outlining why McKernan, “from a molecular biology standpoint” is being “profoundly dishonest”, and he sums up this way:

    “The bottom line is that Kevin McKernan is using his knowledge of genomics to frighting people about the mRNA-based COVID-19 vaccines. What he is claiming, while not as implausible as homeopathy, is pretty damned implausible, and he shows no evidence that any of the mechanisms that he’s trying to scare you with are operative with respect to the Pfizer or Moderna COVID-19 vaccines, other than that he’s detected small amounts of plasmid DNA contamination, likely leftover from the manufacturing process. He has not shown that this DNA can get into the nucleus, much less integrate into the genome and “permanently alter your DNA.” His invocation of increased permeability of the nuclear membrane during cell division is nothing more than more handwaving, particularly given that the vast majority of the cells that take up the LNPs do not replicate. While I like to think that people like McKernan are speaking out of ignorance rather than deception (i.e., spreading misinformation rather than disinformation), McKernan should know better, given his training and expertise.”

    Then the article makes this claim:

    “The TGA did not require tests for genotoxicity or carcinogenicity before providing provisional approval and, in the case of Moderna’s SPIKEVAX, full registration. These tests would be required for GMO product approval by the OGTR.”

    But there’s a reason for that, and primarily it’s the aforementioned fact that they are not GMO’s. But the UK Government website at https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine gives more details on why you wouldn’t test for those:

    “No genotoxicity studies are planned for BNT162b2, as the components of all vaccine constructs are lipids and RNA that are not expected to have genotoxic potential…Carcinogenicity studies with BNT162b2 have not been conducted as the components of all vaccine constructs are lipids and RNA that are not expected to have carcinogenic or tumorigenic potential. Carcinogenicity testing is generally not considered necessary to support the development and licensure of vaccine products for infectious diseases.”

    Finally there’s this:

    “There is already at least one peer-reviewed scientific paper demonstrating that the Pfizer Covid vaccine mRNA is able to enter the human liver cell line and reverse transcribe into DNA in vitro (meaning in a lab dish).”

    In vitro testing in no way replicates what occurs “in vivo” (in our bodies), and the claims raised here are incorrect, as explained at https://healthfeedback.org/claimreview/study-lund-university-didnt-show-covid-19-mrna-vaccines-change-dna-epoch-times/.

    In short, the case being brought is so obviously egregious, without merit and therefore pointless.

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