Australian GP sues Pfizer and Moderna over unapproved GMOs in mRNA Covid vaccines

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.”

The case alleges that Pfizer and Moderna did not apply for a licence for their mRNA Covid vaccines from the Office of the Gene Technology Regulator, Australia

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.”

(click here to view tweet)

Human genome could be permanently altered

The GMO nature of the LNP-mRNA 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). 

Other studies cited in the case materials show the presence of spike protein 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.”

The human genome could be permanently altered

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.”

Dr Julian Fidge, image supplied

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.”

Left: Katie Ashby-Koppens of PJ O’Brien & Associates, Right: Julian Gillespie

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.”

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.”

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* Correction 3 August 2023: An earlier version of this article said, “Additional studies are cited in the case materials showing the presence of Covid vaccine mRNA in the nucleus of human cells…” This has been amended to, “Other studies cited in the case materials show the presence of spike protein mRNA in the nucleus of human cells.”