The TGA is it a Guardian of Australia's Health or Aiding Pharmaceutical Profits over Public Safety

The TGA claims to protect Australians, but by ignoring dangerous levels of DNA contamination in COVID-19 vaccines, it appears to prioritize pharmaceutical profits over public health and safety.

The Therapeutic Goods Administration (TGA), Australia's primary regulator for ensuring the safety of therapeutic goods, has come under severe criticism for its apparent failure to safeguard public health in its oversight of COVID-19 vaccines. In particular, the TGA’s handling of alarming evidence regarding DNA contamination in mRNA vaccines has raised serious ethical and scientific concerns, casting doubt on whether it is truly acting in the best interest of Australians—or in the interests of pharmaceutical giants like Pfizer and Moderna.

TGA’s Dismissal of DNA Contamination Claims: A Deflection of Responsibility

In its October 2024 media release, the TGA addressed widespread concerns about DNA contamination in mRNA COVID-19 vaccines, labeling these reports as “misinformation.” The agency stated, “We are aware of misinformation in recent media and online reports that claim the COVID-19 mRNA vaccines are contaminated with excessive levels of DNA. This is not the case.” The TGA went on to dismiss the findings of independent laboratories that revealed dangerous levels of DNA contamination in the vaccines, claiming these studies lacked the necessary scientific rigor.

Either the TGA denies freedom of information (FOI) requests or returns them mostly redacted, often saying it won’t disclose data because “it is considered to be commercial in confidence by the Sponsors.” From Maryanne Demasi’s substack Click the picture to link to her substack.

However, such an outright dismissal fails to consider the detailed and methodical research conducted by independent experts, including Dr. David Speicher, whose findings provide substantial evidence of contamination far exceeding acceptable safety thresholds. Contrary to the TGA's reassurances, Dr. Speicher’s report revealed that DNA contamination in Pfizer’s COVID-19 vaccines exceeded the TGA's own regulatory limit of 10 ng/dose by up to 145 times. This contamination included not only residual plasmid DNA but also the SV40 promoter, a sequence known for facilitating genomic integration—an alarming risk that the TGA has completely ignored.

Scientific Rigor vs. Regulatory Capture: The Role of the TGA

The TGA’s response to these concerns highlights a deeper issue: its close relationship with the pharmaceutical companies it is meant to regulate. Vaccine manufacturers, including Pfizer and Moderna, provide much of the data that the TGA uses to approve and monitor vaccine safety. This dependency creates an inherent conflict of interest, raising critical questions about the TGA’s objectivity.

British Medical Jounrnal Report June 2022: TGA had the highest proportion of its budget funded by the drug industry. “One must ask; how on earth can they be expected to be objective?”

Dr. Speicher’s report underscores this point by revealing how thoroughly his research was conducted, despite the TGA's claims of methodological flaws. His tests used both Qubit® fluorometry and quantitative PCR (qPCR), ensuring accuracy and repeatability. Results showed that the total DNA in Pfizer vaccine samples ranged from 434 ng/dose to 2,803 ng/dose—far exceeding the TGA's limit of 10 ng/dose. These findings were not only consistent across multiple batches but also confirmed the presence of SV40 promoter-enhancer-ori, a sequence not disclosed to regulators and known to promote nuclear localization, increasing the risk of genomic integration.

The TGA’s dismissal of such scientifically sound findings reflects a troubling pattern of regulatory capture, where the agency, rather than acting as a watchdog for public health, has become an enabler of pharmaceutical profit.

DNA Contamination and the Risk of Genomic Integration

The presence of the SV40 promoter in Pfizer’s vaccines raises profound concerns about long-term health risks, especially genomic integration. As Dr. Speicher’s report highlights, even small quantities of DNA fragments containing the SV40 promoter can penetrate the cell nucleus and integrate into the human genome. A 1999 study by Dean et al. demonstrated that as few as 3 to 10 fragments of DNA containing the SV40 enhancer, when introduced into non-dividing cells, can facilitate genomic integration, which significantly increases the risk of cancer and other mutagenic events.

Dr. Speicher’s findings are particularly troubling because the DNA loads found in Pfizer vaccine samples are among the highest reported globally. Despite this, the TGA has made no effort to address these potential risks, instead continuing to assert the safety of vaccines based on incomplete assessments that ignore the possibility of cumulative harm from multiple doses and the genomic effects of SV40 sequences.

Port Hedland: A Case Study in Public Concern

The October 2024 Special Council Meeting in Port Hedland serves as a microcosm of the growing public distrust in the TGA and its handling of vaccine safety. At the meeting, independent experts, including Dr. Speicher, presented evidence that DNA contamination in Pfizer and Moderna vaccines far exceeded safe limits, with up to 145 times the regulatory threshold in some cases. Community members shared powerful testimonies about the sudden and aggressive health complications they witnessed following vaccination, including cancer and unexplained deaths.

One resident, John Ashenden, emotionally recounted the loss of a friend to aggressive cancer only weeks after receiving the Pfizer vaccine. His story echoed those of many others in the community, who have observed a disturbing rise in adverse events since the vaccine rollout. The testimonies were further supported by scientific data, including reports of genomic integration risks and contamination levels that make the TGA’s reassurances ring hollow.

Sharon Van, a local funeral director, added to the chorus of concern, noting a sharp rise in deaths, particularly within the Aboriginal community, which she believes was disproportionately pressured into receiving vaccines. The personal toll of these stories—coupled with the mounting scientific evidence—demands immediate regulatory accountability and transparency, neither of which the TGA has yet provided.

The TGA’s Deflection of Responsibility and the Need for Accountability

Despite these serious concerns, the TGA continues to downplay the risks, focusing on selectively critiquing the methodologies of independent laboratories while ignoring the real-world consequences of its regulatory failures. Rather than investigate legitimate scientific findings, the TGA has chosen to protect the pharmaceutical industry from scrutiny, undermining the trust that Australians should be able to place in their health regulators.

The TGA’s insistence that the “benefits of vaccines outweigh the risks” becomes increasingly untenable in light of the overwhelming evidence provided by Dr. Speicher and others. The long-term risks posed by DNA contamination, particularly the potential for genomic integration, have not been fully explored or addressed, leaving the public at risk. Moreover, the cumulative effect of multiple doses of contaminated vaccines could amplify these risks, a factor that has been notably absent from the TGA’s safety assessments.

Conclusion: The TGA Must Answer for Its Failures

The Therapeutic Goods Administration’s handling of DNA contamination in COVID-19 mRNA vaccines reflects a profound failure of regulatory oversight. By dismissing credible, independent scientific evidence and prioritizing the interests of pharmaceutical companies, the TGA has endangered the health of Australians. The presence of the SV40 promoter in Pfizer vaccines, along with contamination levels far exceeding safety limits, demands immediate investigation and transparency—something the TGA has thus far refused to provide.

As the outcry from communities like Port Hedland grows louder, the TGA must acknowledge its failings and take concrete steps to restore public trust. This begins with a full and independent review of vaccine safety data, including the risks posed by DNA contamination and genomic integration. Anything less would be a betrayal of the public trust and a continuation of the TGA’s abdication of its responsibility to protect the health of Australians.

It is time for the TGA to stop deflecting and start addressing the serious risks that have been exposed. The future of public health in Australia depends on it.