The Therapeutic Goods Administration (TGA) is 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.

TGA 18 October 2024

So opens the TGA report Addressing misinformation about excessive DNA in the mRNA vaccines. It is, for those of us aware of this issue, an understatement. The sheer volume and scope of misinformation, combined with relentless pressure from repeat offenders including members of the Australian parliament, more accurately suggests a campaign. A calculated campaign of misinformation designed to spread fear and intimidate the vaccine hesitant. Despite there being accepted means for discerning DNA residue in vaccines, two claims persist. Namely levels are hundreds of times greater than the accepted safe level, and that aggressive cancers will, and do, directly result.

Background

The original claim stems from a preprint paper by Kevin McKernan dated 11 April 2023. Amplitude, via the Australian anti-COVID vaccine lobby, was lent to this claim in July 2023. The legal guru behind all Australian court cases to challenge approval of COVID-19 vaccines, retired barrister Julian Gillespie, penned The Canaries in the Human DNA Mine. Falsely labelled “peer reviewed” by his anti-vaccine compatriots, it was published in the unabashedly anti-vaccine International Journal of Vaccine Theory, Practice, and Research. Gillespie also crafted the case material used by Dr. Julian Fidge, in what became known as the Fidge v Pfizer case in which Fidge was represented by Katie Ashby-Koppens of P. J. O’Brien and Associates. I summarised the unsuccessful case here, in April this year. Gillespie and Co. followed with a conspiratorial constitutional complaint against the presiding judge, Justice Helen Rofe. Then via a High Court writ they targeted Chief Justice Debra Mortimer for not accepting their complaint. Both complaints were lodged on behalf of Dr. Fidge

Around the same time, the outrage manufactured by the anti-vax lobby shifted from the claim in Fidge v Pfizer that mRNA vaccines were Genetically Modified Organisms (GMOs), to the claim that vast amounts of DNA were contaminating these vaccines. Julian Gillespie, who wants a COVID Royal Commission, publishes for his “good substack folk” regularly on DNA contamination. He claims to have commissioned Canadian molecular virologist Dr. David Speicher to pursue said contamination, ultimately announcing confirmation on 6 June. Speicher was not a surprise choice for Gillespie. He had published with McKernan, Jessica Rose, Maria Gutschi, and David Wiseman in Canada in October 2023, reaching the contamination conclusions Gillespie wants to hear about.

It bears stressing that Kevin McKernan’s preprints lost credibility long ago, when it became apparent the vials he tested were of unknown origin. More so, if origin is unknown then cold chain transport requirements are by default, breached. In October 2023, David Gorski referred to McKernan’s initial preprint as an “awful study” and follow up studies being “equally as bad”. Thus it is unsurprising further attempts were made to label COVID vaccines as DNA contaminated. The Global Vaccine Data Network provide an excellent refutation of what they call Plasmid-Gate. As a highly COVID-19 vaccinated nation, Australia is used in their piece as an example to debunk the claim of so-called “turbo cancers” resulting from COVID-19 vaccination. SBS recently reported that last year, biologist Phillip Buckhaults from the University of South Carolina spoke before a state panel postulating the possible consequences of DNA contamination. When his comments took flight on social media he quickly followed up on X with insistence that such a risk was “purely theoretical”. They further reported that:

Dr Paul Offit of the Children’s Hospital of Philadelphia said [DNA] fragments were “clinically and utterly harmless”.

“These DNA fragments would have to enter the cytoplasm, which is that part of the cell outside of the nucleus, and our cytoplasm hates foreign DNA,” Offit said. “It has innate immune mechanisms as well as enzymes to destroy foreign DNA.”

Also interested in supposed DNA contamination of mRNA vaccines are Senators Malcolm Roberts, Gerard Rennick, Ralph Babet, Alex Antic and Russell Broadbent. Rennick has pushed both the GMO and DNA contamination angle for well over a year. Broadbent remains vocal in parliament to this day, has congratulated Port Hedland Council for calling for an end to COVID vaccines and has furnished Australia’s PM with material on the matter. Broadbent raised his concerns in parliament on 18 November, and I recommend watching this 5 minute video of him speaking.

Another voice to echo Julian Gillespie, is erstwhile ABC journalist Maryanne Demasi. Perhaps her contribution is best summed up in the COVID vaccine conspiracy film she narrated, The Truth – About COVID-19 shots. Erroneously labeled a documentary, it was raved about by Gillespie. And understandably so, given that it includes all his favourite vaccine conspiracies, champions the case and complaints associated with Fidge v Pfizer and lists Gillespie as a source. Demasi also has a Substack account, and has kept her subscribers up to date with DNA contamination developments. In addition Demasi claims the TGA “hides from” reports of SIDS, post vaccination, the TGA and FDA ignored DNA contamination of the HPV vaccine Gardasil, and of course that the TGA response to the claim that mRNA vaccines exhibit DNA contamination, is wrong.

TGA Statements

The first TGA report on DNA contamination was, as stated, on 18 October. The position taken by the TGA is that the claims made about DNA contamination are mis-informative, as they “currently fall short of the scientific rigour expected in pharmaceutical testing”. The World Health Organisation (WHO) stipulate the limit for residual DNA as <10ng per dose. The TGA report cites five areas of concern.

• Selective reporting and method validation

Certain labs involved in testing have used fluorometry which can over-estimate DNA levels if the sample contains mRNA. This is because the dye used binds to both DNA and mRNA. In COVID-19 vaccines, stress the TGA, the former is present in minute amounts and the latter is comparatively abundant. The method also lacks validation as per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) [available here]. Put simply, the test must be recognised as doing what is claimed. More so, the requirements of specificity demand that results reveal levels of DNA without also measuring for mRNA. Finally, the physical reference materials were not adequately defined.

• Issues with samples

Initial studies used 2 or 3 vials which were past the use-by date and had previously been opened and used. This does not constitute a suitable sample. As mentioned above with McKernan, the provenance of vials is unknown. Thus source, location, temperature and custody is also unknown. The expected regulatory controls that should be in place to ensure the accuracy of results was lacking. Integrity of testing is a mere assumption and in this case results cannot be deemed reliable. Again reflecting the problems with McKernon’s study, there is no cold chain to speak of, much less that which is demanded by the TGA. Some did not have temperature loggers with them.

• Laboratory status

Accreditation of the laboratories is unknown and Good Manufacturing Practice (GMP) certification is not evident. The international standard ISO/IEC 17025 : General requirements for the competence of testing and calibration laboratories, does not appear to be met. Robust results associated with such accreditation cannot be assumed.

• Biotechnology medicines have been available since the 1980s

Apart from mRNA vaccines, recombinant proteins are used in many biotechnology products such as insulin, growth factors, cancer medicines, autoimmune therapies and other vaccines. After purification, residual DNA may be found in all products using DNA as a starting material. Strict guidelines control the final amount. Current techniques have been safe for over 40 years and the TGA continue to monitor residual DNA prior to approval. Manufacturing and test results for mRNA vaccines must be provided to the TGA, who have also independently tested 27 batches by qPCR to confirm residual DNA. They continue:

The quality limits ensure that there is less than 10 ng present per dose – or less than ten billionths of a gram in each dose. These limits are used by the TGA, the World Health Organization, the United States Food and Drug Administration and other international regulatory agencies.

• Residual DNA in Biotechnology Products – safety

No causal link between COVID-19 vaccines and cancer has been established by the TGA or any other regulator in the world. No evidence exists to support the claim that mRNA vaccines or biological medicines lead to integration of residual DNA into human DNA genome. This includes insulin, injected multiple times per day over a lifetime. Animal studies used 200 times the clinical dose of mRNA vaccines and revealed no adverse impacts on female and male fertility, foetal deaths, birth defects, or developmental delays. 13 billion COVID-19 vaccines have been administered globally. The safety profile is positive with benefits continuing to outweigh risks.

The response to the 18 October TGA report from vocal members of the anti-vaccine lobby was predictably aggressive with ongoing insistence that the TGA were refusing to “accept” the evidence of DNA contamination. On 7 November the TGA published Summary report of residual DNA and endotoxin on CoVID-19 mRNA vaccines conducted by TGA Laboratories [available here]. This report discusses the importance of batch release testing done on mRNA vaccines, Comirnaty (Pfizer) and Spikevax (Moderna). As of October 2024, 212 batches have been released by the TGA whilst 28 batches have been independently tested. Key findings are:

• Residual DNA Testing: The TGA Laboratories tested 28 batches of mRNA vaccines and confirmed that all batches complied with the World Health Organization recommended limit of up to 10 ng per dose. This confirmed the manufacturing process removes almost all DNA starting material and the vaccines are within the safe DNA residual limit. The quantitative PCR (qPCR) method was validated to ensure accuracy and reliability.
• Endotoxin Testing: Every batch of both mRNA vaccines released in Australia was tested for bacterial endotoxins using a validated Limulus amebocyte lysate (LAL) assay. Endotoxin was tested to a level of 5 Endotoxin Units (EU) per mL and all batches were below this level.
• The report concludes that the current mRNA manufacturing processes, as evaluated and approved by the TGA, effectively control levels of residual DNA and bacterial endotoxins to a safe level.

The Batch Release Assessment for COVID-19 vaccines may be accessed here. Methodology of testing and international requirements are explained in depth in the summary report. Regarding Moderna’s Spikevax, 13 batches were tested at the TGA Laboratories, all of which complied with WHO recommended residual DNA limit of <10ng/dose (Table 1). Regarding Pfizer’s Comirnaty, 15 batches were tested at the TGA Laboratories, all of which complied with WHO recommended residual DNA limit of <10ng/dose (Table 2).

The TGA conclude the summary report as follows:

All batches of mRNA vaccines tested for residual DNA content in the TGA Laboratories were found to comply with the WHO recommended limit for residual DNA of up to 10 ng per dose, consistent with the results reported by manufacturers.

Current mRNA manufacturing processes, as evaluated and approved by the TGA, include breakdown of plasmid DNA and additional purification strategies. These processes are effective in controlling levels of residual plasmid DNA to ensure compliance with residual DNA guidelines.

To date, all batches of Comirnaty and Spikevax released to the Australian market have been tested for bacterial endotoxin content by the TGA Laboratories. All batches were found to comply with the registered bacterial endotoxin limit for the particular product. This is consistent with the results reported by manufacturers as reviewed as part of the batch release process. The assay tests these products to the level of 5 EU/mL and every batch demonstrated levels below this limit.

Julian Gillespie has already promised he will have answers for the points raised by the TGA, and has even asked ChatGPT if Speicher’s methodology could have been improved by observing ICH Q2(R2). After uploading Speicher’s report. Chat replied that he appears to go beyond what ICH Q2(R2) covers and thus, his method couldn’t substantially be improved. Gillespie reckons this meant, “just like good and new and adaptive science strives to do, and David did do this .. he went beyond“.

Ah yes. We have a while to go on this topic it seems.