The Australian Federal Court is being asked two questions: Is the COVID-19 vaccine correctly classified as a GMO; and if so, have Pfizer and Moderna broken the law?

The relevant definitions are applied in connection with products containing “LNP-modRNA complexes.”
Relevantly, the ‘LNP-modRNA complexes’ meet the definition of an organism, namely:
“organism” means any biological entity that is:
(a) viable; or
(b) capable of reproduction; or
(c) capable of transferring genetic material.
First, the LNP-modRNA complexes satisfy being ‘any biological entity’.
Second, the LNP-modRNA complexes do and are ‘capable of transferring genetic material’, insofar as the LNP encapsulating the modRNA is biodistributed throughout the human body and directly assists in transferring (transfecting) the modRNA across cell membranes and into the cytoplasm of cells of all organ types and classes, including brain, heart, kidneys, liver, testes, ovaries and unborn children. This encapsulation, transport and transfection by means of LNPs involves the physical ‘transfer of genetic material’ throughout the recipients’ bodies.
Having satisfied the above, it follows that:
“genetically modified organism” means:
(a) an organism that has been modified by gene technology;
Where:
“gene technology” means any technique for the modification of genes or other genetic material.
When a product meets the above definitions, a sponsor or manufacturer must first obtain a GMO licence for one or more of the following “dealings” under section 10 of the Act:
“deal with”, in relation to a GMO, means the following: (a) conduct experiments with the GMO;
(b) make, develop, produce or manufacture the GMO; (c) breed the GMO;
(d) propagate the GMO;
(e) use the GMO in the course of manufacture of a thing that is not the GMO;
(f) grow, raise or culture the GMO;
(g) import the GMO;
(h) transport the GMO;
(i) dispose of the GMO;
and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i).
The degree of genetic modifications involved in the creation of the modRNA is beyond doubt and well established. The finer details of the genetic modifications involved are a matter of evidence to be presented and explained to the court.
The above definitions are not controversial and can be found under EU law and similar GMO legislation that exists in many other countries.
Both Pfizer and Moderna have long been aware of these legal definitions but chose to ignore them when attempting to introduce their C19 products to the Australian market. Moreover, Australia’s Gene Technology Regulator may have ‘looked the other way’ when Pfizer and Moderna wanted to import and transport their products here.
AstraZeneca, on the other hand, did not seek to avoid its legal obligations and correctly applied for a GMO licence from the Australian Office of the Gene Technology Regulator (OGTR) before seeking provisional approval from the Australian TGA: see DIR 180.
‘Dealing’ with a GMO in Australia (as in most other jurisdictions) is a serious criminal offence: see section 32, section 33 and section 38 of the Gene Technology Act.
Pfizer and Moderna’s failure to obtain GMO licences in Australia before seeking provisional approval from the TGA means that both companies continue to commit the serious criminal offences described above. The TGA’s grant of provisional approval never cured these ongoing serious criminal offences.
The TGA should in fact have first consulted (under section 30C) with the OGTR about the LNP-modRNA before granting provisional approval. The TGA was instead deliberately blind to this issue.
Australia’s Gene Technology Regulator admits that the modRNA products are GMOs
Recently and fortunately, the above legal issues have been largely clarified following a critical admission by Australia’s Gene Technology Regulator, Dr Raj Bhula.
In February 2023, the Gene Technology Regulator told the Senate Community Affairs Legislation Committee in evidence:
“The mRNA Covid-19 vaccines did not involve any step of genetic modification.”
Ten months later, on 26 October 2023, the regulator gave evidence that was the exact opposite:
a) The modRNA products involve gene technology.
b) Gene technology is used to genetically modify the products.
c) Had this manufacturing step taken place in Australia, the products would have had to be regulated by the OGTR.
To be completely clear, Dr Bhula, Australia’s Gene Technology Regulator (on page 127), stated:
If the mRNA had actually been manufactured here — and it is correct that gene technology was used to modify the mRNA — then under the Gene Technology Act there would have been a requirement for approval for that manufacturing step.
With regard to — ‘there would have been a requirement for approval’ — under the Gene Technology Act there is ONLY ONE approval that Dr Bhula is talking about, namely the approval of a GMO licence.
To be clear, the Gene Technology Act and the OGTR regulate and approve ONLY ONE thing: GMOs.
As a consequence, the above answer is an implicit admission that Dr Bhula and the Committee (she refers to her advisers on the Gene Technology Technical Advisory Committee) have always understood and regarded the modRNA products as GMOs.
As a result, and with regard to the post-manufacture steps of importing and transporting GMOs into and around Australia (‘dealings’ under section 10 above), both Pfizer and Moderna were always required to apply for GMO licences from the OGTR, as import and transport are a further form of ‘dealing’ — the fact that the products are manufactured overseas is irrelevant to these subsequent forms of dealing involving import and transport — they are dealings that require GMO licences.
The position regarding overseas production put forward by Dr Bhula is unsustainable in law, being conduct that is further aggravated by the Gene Technology Regulator, and the OGTR continues to ignore the science that has been provided to the OGTR by an Australian law firm seeking to inform the OGTR and its advisory body, the Gene Technology Technical Advisory Committee (GTTAC), specifically showing that the LNP-modRNA complexes are involved in:
Nuclear localisation (entry into the nucleus): Sattar et al. 2022.
Once in the nucleus, reverse transcription: Aldén et al. 2022.
Reverse transcription involving genomic integration and inheritance in offspring: Qin et al. 2022.
The above papers demonstrate modes of action consistent with the worst possible threats to genomic (natural) DNA that GMO legislation is designed to protect the public from being exposed to.
Both Pfizer and Moderna, by virtue of their declared expertise, are by law understood to have known all of the above.
In the event that both companies now seek to claim that it was an oversight, that is no excuse. Under criminal law, both companies have also been ‘reckless’ and/or ‘negligent’ in investigating and correctly verifying the above legal definitions, and the subsequent peer-reviewed articles confirming the destructive effects of their products on the human genome. Where recklessness and/or negligence is shown by experts in a field, those experts are taken always to have had “knowledge” of their conduct.
In short, Pfizer and Moderna always knew that their C19 products are or contain genetically modified organisms.
Pfizer and Moderna’s C19 products are grossly contaminated with another GMO
The above is compounded by the recent discovery by genomics expert Kevin McKernan of dangerously excessive DNA cell-substrate contamination. This discovery has now been independently verified by other internationally recognised laboratories using different vials, proving gross, pre-existing and ongoing global supply contamination of Pfizer and Moderna. Recently Canada also confirmed mass DNA contamination in 27 vials.
The synthetic DNA (modDNA) contamination is somewhere between 188–509 times above legal limits.
This contamination is, however, far worse than anticipated by outdated regulations, as the modDNA is also encapsulated in LNPs, ensuring biodistribution throughout human bodies and transfection into cells of all major organ types, including the brain, heart, ovaries, testes, liver, spleen, eyes and unborn children.
For the purposes of the Gene Technology Act, this excessive contamination also meets the legal definitions to be properly regarded as genetically modified organisms and perhaps the worst type of GMO, as genomic integration with chromosomal DNA does not require reverse transcription, and some of this modDNA (from Pfizer) has the potential to become ‘replication competent’ (self-replicating) in certain individuals known to be infected with SV40-related viruses.
Conversely, and as a strict matter of law, both Pfizer and Moderna were required to hold GMO licences in order to ‘deal with’ their LNP-modDNA contamination in Australia, even though any organisation responsible for such a licence (the OGTR in this case) would never permit any product in their country that contains this type of GMO contamination. This type of GMO contamination changes the course of humanity and what it means to be human.
In these proceedings the applicant (Dr Julian Fidge), together with the legal team that discovered and created the proceedings (Julian Gillespie and Katie Ashby-Koppens), now seeks to put the above facts before the court.
In the event that the court follows and accepts the evidence that the respondents’ products contain GMOs, and both are found to be committing ongoing serious criminal offences by dealing with GMOs in Australia without a licence, the court should feel compelled to issue an injunction under paragraph 147 restraining Pfizer and Moderna from further dealings in Australia, a result that would also require the cessation of any further use of the Pfizer and Moderna C19 products in Australia.
The documents below begin to detail the above facts further:
Letter to the Registrar, Federal Court of Australia, Re Urgency (sealed)
original application (sealed – to be amended to correct paragraphs 4(c) and (d) to instead refer to 4.ai – iii. and 4.bi – ii NOT 5.ai – iii. and 5.bi – ii)
Letter of demand, Pfizer – served 4 July 2023 (response – denies GMO allegations – failed to address modDNA contamination)
Letter of demand, Moderna – served 4 July 2023 (no response/reply)
Letter of demand, TGA – delivered 4 July 2023 (no response/reply)
Letter of demand, OGTR – delivered 4 July 2023 (no response/reply)
Criminal brief of information and evidence
As described above, the conduct of Pfizer and Moderna involves the commission of ongoing serious criminal offences.
The same team of Katie Ashby-Koppens, Julian Gillespie, together with lawyer Peter Fam, also prepared a criminal Brief of Information & Evidence in connection with Pfizer and Moderna’s criminal conduct, which Brief was presented to the Australian Federal Police (AFP) and, under a letter from Senator Gerard Rennick, was also presented to Australia’s Attorney-General Mark Dreyfus.
Without proper explanation, the AFP suddenly terminated any further action on the Brief.
To date the Attorney-General has not responded to Senator Rennick.
In light of the clear admissions by the Gene Technology Regulator above that the Pfizer and Moderna products are GMOs, the AFP and the Attorney-General now have little choice but to refer the criminal brief to the Commonwealth Director of Public Prosecutions (CDPP) to bring criminal charges against Pfizer and Moderna.
However, after the AG has failed to respond, it appears reluctant to take this proper course, so on 4 December 2023 a revised and simplified criminal Brief was presented directly to Australia’s CDPP, Raelene Sharp KC.