TGA responds to COVID vaccine contamination claims raised at Port Hedland council meeting

The Australian Therapeutic Goods Administration has rubbished claims of DNA contamination raised at a Town of Port Hedland council meeting in October. In a statement released on October 18, the TGA labelled the claims as “misinformation” and said all COVID-19 vaccines approved in Australia had been rigorously assessed and meet the TGA’s standards for safety, quality and efficacy. “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 statement said. “These reports are based on studies conducted by a small number of laboratories that have attempted to investigate the amount of DNA in COVID-19 vaccines. “While the TGA welcomes and constantly reviews the latest scientific evidence about the safety of vaccines and other biotechnology products, these recent studies fail to apply the required scientific rigour expected in pharmaceutical testing. “As such, the results are not robust or reliable and are creating confusion and concern regarding the safety of vaccines.” Councillor Adrian McRae, who tabled the motion, labelled the TGA’s response as “arrogant” and “insulting”. “As expected, the TGA has done a complete misdirect and has both refused to answer our questions or address our concerns,” he said. “Rather than use science to disprove what we now all-but know to be true, the TGA is relying on outdated science and back information that does not address the concerns and the now many times replicated science that has been bought forth recently by Dr David Speicher PhD, among several other eminent scientists around the world. “Note to TGA: gaslighting, name-calling and ad hominem will no longer work on an increasingly aware Australian public. Falling on your swords might be your best option at this point.” Despite Cr McRae’s assertion, the TGA addressed many of the claims in the statement. The TGA raised several concerns about recent reports such as Dr Speicher’s, pointing out issues such as selective reporting, inadequate validation methods and problematic sample handling. One major issue involved the use of fluorometry to measure DNA levels in COVID-19 vaccines, which overestimates DNA due to the presence of mRNA. The TGA said the fluorescent dye binds to both DNA and mRNA, leading to inaccurate results. According to the TGA, this method doesn’t meet the stringent requirements for pharmaceutical testing. Moreover, some studies used only a limited number of vials — sometimes just three — which were often past their expiration date, had been opened previously or were stored improperly without maintaining the required “cold chain” conditions necessary for vaccine safety and efficacy. The exact origin of these samples was also unclear to the TGA, leaving gaps in crucial information like their storage history and handling conditions. The TGA said every batch of mRNA vaccines released in Australia had met regulatory standards for residual DNA concentration. It said it had independently tested 27 batches using qPCR and confirmed all met the required limits. Tthe TGA questioned the accreditation of the laboratories involved in the studies mentioned, saying there was no evidence those labs held Good Manufacturing Practice certification, which is necessary for conducting pharmaceutical testing. The TGA emphasised that neither they nor any other international health regulators had found any link between COVID-19 vaccines and cancer. No evidence supported claims that residual DNA from mRNA vaccines integrates into human DNA. This is consistent with findings from other biological medicines used in Australia, including insulin. Animal studies, where doses up to 200 times the clinical amount were tested, showed no adverse effects on fertility, fetal development or birth outcomes. The TGA said that with more than 13 billion doses of COVID-19 vaccines administered globally, the safety profile of these vaccines remained strong across all age groups and their benefits far outweighed any potential risks.