Summary
➡ The Australian court’s dismissal of a case has left important questions about DNA contamination and genetic risks unanswered. This has led to growing mistrust, especially as the government and health regulators have not openly addressed these issues. The government could be held responsible for any negative health effects due to approving products without fully understanding the risks. This article calls for transparency, accountability, and a commitment to public health, demanding justice for those who have suffered and ensuring such a situation does not happen again.
Transcript
Sample vials of Pfizer and Moderna, which have been sourced from Europe, Japan, the US, Canada and Australia, have all been deemed contaminated. Kevin McKernan, a former research director for the Human Genome Project, was the first scientist to detect billions of DNA fragments in the vials. The fragments originate from the circular DNA plasmid that was used in the manufacturing process. In Pfizer’s product, it included sequences related to the simian virus 40, or SV40. The presence of segments of SV40 is particularly concerning because it has a nuclear localization signal capable of facilitating the passage of these DNA fragments into the nucleus of cells, potentially leading to genetic disruptions and cancer.
David Speaker, a molecular virologist, was the first to confirm contamination in mRNA vials sourced from Australia. He found the Pfizer vials were contaminated at levels 350 times above the TGA accepted limit, while the Moderna vials were 200 times above the limit. Various major regulators such as the US FDA, Health Canada and Australia’s TGA have all denied that the presence of these DNA fragments pose any safety risk despite never having carried out any safety testing. Philip Buchholz, an expert in cancer genomics from the University of South It can increase a person’s risk of developing cancer or autoimmune diseases.
He testified before a South Carolina Senate hearing about his concerns. Preliminary testing by McKernan has indicated that the DNA fragments in Pfizer’s product can integrate into the genome of cells cultured in a lab. Now, studies are underway to assess whether the contaminating DNA fragments have been able to integrate into the genome of people who were vaccinated. This entire contamination scandal highlights the catastrophic failure in the regulatory process. The mRNA injections have always been referred to as vaccines, but the fact that they contain genetic material to prevent and treat disease means they meet the definition of gene therapies.
According to the Cleveland Clinic, in gene therapy, genetic material is delivered to your cells and changes how your cells produce proteins. That’s exactly how the mRNA injections are designed to work, and therefore should be thought of as gene therapies rather than vaccines. The genetic material is delivered to cells using a fatty substance called lipid nanoparticles. It protects the genetic material from being destroyed by enzymes and allows that material to be transfected or transferred into cells. Once inside the cells, the genetic material known as messenger RNA contains instructions for making spike protein, which exists on the surface of the SARS-CoV-2 virus.
Once people’s cells become factories for making spike protein, the body can mount an immune response, and that means the person will develop protective antibodies in preparation for when they confront the virus in the real world. Health authorities told the public that the lipid nanoparticles containing messenger RNA would remain mostly in the arm after injection and only last up to 48 hours. That would be true if it was natural messenger RNA, which is normally highly unstable and would degrade in the body as soon as it is injected. But in developing these vaccines, researchers worked out a way to modify the messenger RNA and stabilize it using genetic engineering techniques, which is why it’s sometimes referred to as modified RNA.
As a result, modified RNA doesn’t degrade quickly in the body as we were told. In fact, biodistribution studies in animals showed the modified RNA wrapped in lipid nanoparticles could travel throughout the body and deposit in tissues like the spleen, bone marrow, lungs, testes, and ovaries. The manufacturers never tested whether this was toxic to our genes or whether it might cause cancer. Nor did the regulators insist that the manufacturers carry out these tests before they were injected into humans. In turn, none of these uncertainties were ever communicated to people who received the injections, effectively denying them of informed consent and leaving them exposed to potential harms in the future.
Genotherapies have held great hope in treating or curing many different health conditions, including cancer, sickle cell disease, hemophilia, and cystic fibrosis. But the field has been plagued with setbacks after catastrophic reports of people dying or developing cancer due to mutations in their genome caused by the gene therapy itself. That’s why it’s imperative that these products undergo regular testing, strict regulatory compliance, and continuous quality control monitoring to ensure their safety and efficacy as is required by law. Regulatory scrutiny is not just important, it’s essential to safeguard public health. Compliance ensures that all safety standards and protocols are strictly followed, providing a layer of protection against the inherent risks of gene therapies.
In Australia, the classification for what defines a genetically modified organism, or GMO, is based on the Gene Technology Act 2000, which defines a GMO as any biological entity capable of transferring genetic material that has been created through recombinant technology. The formulation of lipid nanoparticles with modified RNA designed to be transferred into cells also aligns with the legal definition of a GMO. Australia has always had a rigorous testing and regulatory approval process to ensure the safety of human gene therapies, but when it came to the COVID-19 injections, the normal safeguards in regulation were disregarded.
In Senate hearings, it was revealed that neither Pfizer nor Moderna sought approval to use their products from Australia’s Office of the Gene Technology Regulator. Interestingly, however, AstraZeneca did adhere to the strict regulatory framework outlined in the Gene Technology Act for its COVID vaccine. It applied for and obtained a GMO license, which involved a comprehensive risk assessment and months of public consultation. And it was this critical step that Pfizer and Moderna managed to bypass. The TGA denies these products contain GMOs, calling it misinformation. However, numerous scientists and lawyers agree the COVID mRNA injections fulfill the legal definition to be classified as GMO products under Australian law.
In fact, the injections also meet the criteria under GMO laws in England, South Africa and the European Union and satisfy FDA guidance in the US for being understood as gene therapies involving GMOs. The GMO case known as Dr. Julian Fidge versus Pfizer and Moderna was devised by former barrister Julian Gillespie and was brought by the Federal Court of Australia by Katie Ashby-Coppins of PJ O’Brien’s and Associates, acting for Dr. Julian Fidge. Fidge alleged that Pfizer and Moderna failed to seek the necessary GMO regulatory approval and GMO licenses as per the Gene Technology Act 2000 and therefore filed for an injunction to prevent the manufacturers from distributing their mRNA products in Australia.
It was argued that failing to obtain GMO licenses constituted a significant breach of regulatory compliance, possibly amounting to serious criminal acts. Essentially, Pfizer and Moderna were allowed to bypass crucial safety assessments and public consultations, as well as avoiding a thorough risk assessment that would have evaluated the potential serious negative effects such as risks of altering a person’s genome or increasing the potential for triggering diseases like cancer. And the fact that AstraZeneca complied with Australian GMO laws, while Pfizer and Moderna did not, raises serious legal questions about the integrity of the regulatory approval process in Australia.
We know that Pfizer met with the Office of the Gene Technology Regulator in late 2020, which may have been when they were given the green light to bypass the GMO licensing process and proceed directly to the TGA for provisional approval. This alleged illegal circumvention of established regulatory protocols undermines the very principles and laws designed to protect public health and ensure the safety of medical interventions. Unfortunately, the GMO case of Pfizer versus Pfizer and Moderna was dismissed by Justice Helen Roeth in the Federal Court in March 2024, after she ruled that Dr.
Pfizer lacked the legal standing, meaning that he was not aggrieved by the failure of Pfizer and Moderna to obtain GMO licenses. Upon closer scrutiny, public records showed that before Judge Roeth was appointed as Federal Court Judge in 2021, she provided legal counsel for Pfizer on at least five occasions between 2003 and 2006. Justice Roeth also has extended family ties to pharmaceutical fortune and professional ties in the field of medical research. These prior relationships were not disclosed during the proceedings, representing a serious conflict of interest and raises questions about why Judge Roeth did not recuse herself from presiding over the case.
For judges are duty bound to disclose any potential or perceived conflicts of interest, to maintain the integrity of the judicial process, and failure to do so undermines public confidence in the fairness and impartiality of the judiciary. Subsequently, a complaint to Chief Justice Deborah Mortimer has now been lodged by solicitors PJ O’Brien and associates on behalf of Dr. Julian Fidge. It requests an investigation into Judge Roeth’s decision to dismiss his case and asks that it be heard again by a new judge with no conflicts of interest. The dismissal has also left the substantive issues of the case unanswered and prevented the court from evaluating critical evidence, including the high levels of contamination and the potential long-term genetic risks.
A copy of the complaint against Justice Roeth has been circulated to all sitting MPs and senators in the Australian Parliament. Under Section 72 of the Constitution, if there is any potential misbehavior of a judge, the Parliament can investigate and may remove the judge if misbehavior is proven. The reluctance of the Australian Department of Health and of the Office of the Gene Technology Regulator to acknowledge and address the issue of DNA contamination openly and transparently only adds to the growing mistrust. Gillespie and Ashby Coppens have also presented this evidence to the Commonwealth Director of Public Prosecutions and the Australian Attorney General, both of whom have remained silent concerning the allegations of serious criminal conduct.
The potential liability to the Government is substantial. By approving these products without adequately evaluating the consequences of DNA contamination means the Government may be held accountable for any adverse health outcomes. This liability could extend to regulatory bodies like the TGA and the Office of the Gene Technology Regulator for failing to uphold safety standards and protect public health. The phrase safe and effective was a mantra used by health bureaucrats and politicians, but it was clear from the outset these injections were rushed through clinical trials as part of Operation Warp Speed. The TGA only offered provisional approval, which by definition means there are limited data on safety, especially in the medium and long term.
The lack of transparency about what was known and unknown has raised serious questions. Politicians and health authorities asserted that getting jabbed would keep the community safe because it would prevent infection and transmission. Only later was it revealed to the public that the manufacturers never even tested for transmission in the trials. Authorities nonetheless charged ahead with policies to mandate the injections based on a false premise. Several studies now demonstrate the extent of societal and individual harms caused by mandates, and notable politicians have begun apologizing for the harsh policy. Authorities also claimed the mRNA injections were 95% effective at preventing serious disease and death, but this was misleading.
Not only was there no decrease in deaths in the pivotal trials, the 95% statistic for preventing infection was based on a relative risk reduction. The absolute risk reduction, which is more relevant to the individual, was only about 1%. The claim that there was a pandemic of the unvaccinated was also false. Throughout 2021 and 2022, data showed vaccinated individuals were being infected and hospitalized at significantly higher rates than those who were unvaccinated. Fear mongering was a feature of the nightly news. Doctors claimed young children were at significant risk of serious COVID-19, but the data actually showed that young healthy children had an almost zero risk of serious disease.
Authorities and professional societies also maintained that COVID injections were safe for use during pregnancy and breastfeeding. However, this advice lacked evidence. Pregnant and breastfeeding women were excluded from the pivotal clinical trials, and when Pfizer finally commenced these trials, they were abandoned due to a lack of participation. But this didn’t dampen the enthusiasm of authorities who continued to provide baseless safety assurances to women during their most vulnerable time. The veil of deception has been lifted, revealing a stark reality. The Pfizer and Moderna injections, far from the conventional immunisations they were portrayed to be, are more like gene therapies that carry grave risks.
Millions of Australians have been unwittingly subjected to experimental gene-based injections, and it appears our regulators have been complicit in failing to carry out the most basic duty of protecting the public. Every Australian has the right to be fully informed, but the true extent of harm has been kept secret, and Australians were denied the information necessary for giving legally valid informed consent to receive these injections. Government officers and regulatory bodies who ignored red flags, bypassed crucial safety protocols, and silenced critical voices must be brought to justice. We stand at a crossroads.
Families who’ve lost loved ones, and the large numbers of Australians who’ve died must not be forgotten. The path forward demands transparency, accountability, and an unwavering commitment to safeguarding public health. The voices of those injured must be heard, their experiences validated, and their suffering acknowledged. This is a call to action, a demand for justice, and a pledge to ensure that such a travesty never happens again. Let this be the moment we rise together, informed and resolute, to reclaim our health, our safety standards, and our trust in those responsible for keeping guard over the safety of therapeutic goods.
For the sake of our future and the generations to come, we must not rest until every truth is uncovered, every wrong is righted, and those responsible are made to answer for what has been done. [tr:trw].
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