TGA rejects concerns over DNA fragments found in mRNA vaccines
But the public has had enough, calling out the regulator for its hypocrisy and lack of transparency.
After an article about the discovery of residual DNA in the Gardasil HPV vaccine, and multiple calls this month for the Prime Minister to “immediately suspend” the covid-19 mRNA vaccines, the Australian drug regulator has responded.
The Therapeutic Goods Administration (TGA) released a statement “addressing misinformation about excessive DNA in the mRNA vaccines.”
But, within hours of posting on X, the TGA was met with a torrent of public outrage, calling out the regulator for its hypocrisy and lack of transparency.
The irony is that I’ve been chasing responses from the TGA for months and endured long delays, obfuscation and utter disregard, only to see the regulator now claim that residual DNA in the covid-19 vaccines has all been ‘misinformation.’
The TGA said it is “not the case” that covid-19 mRNA vaccines are “contaminated with excessive levels of DNA,” and that reports online “are based on studies that currently fall short of the scientific rigor expected in pharmaceutical testing.”
“To date,” the regulator wrote, “the TGA has also independently tested 27 batches of COVID-19 mRNA vaccines by qPCR to confirm the residual DNA concentration in the final product. The vaccines met the required limits for residual DNA.”
But attempts to obtain these data have failed.
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.”
“It’s time for regulators to restore public trust and release the data,” said David Wiseman, a research bioscientist in medical product development. “Until then, why should we inject anyone, especially children, with a vaccine without disclosing these, and other kinds of data?”
The TGA has been presented with compelling evidence from multiple, highly regarded scientists who’ve also made their methods public for independent scrutiny, but the agency insists the findings are unverified.
Phillip Buckhaults, a cancer genomics expert at the University of South Carolina, is one of the scientists conducting these studies and he told me that he wanted other regulators to replicate his findings.
“Many want to just discredit the methodology - I went overboard with my methodology so that anybody can see how I did it,” he remarked frustrated by regulators downplaying legitimate concerns.
In fact, the methods used by the TGA to measure residual DNA appear to be inadequate.
Kevin McKernan, the genomics expert who first discovered residual DNA in the mRNA vaccines, has called out the regulator for applying methods that are likely to under-estimate levels by 100 times.
The TGA is only performing an assay for the Kanamycin resistance gene or “Kan R gene” on the plasmid DNA – but because the plasmid has been digested into billions of pieces during the manufacturing process, the chances of actually finding the gene, are remote.
Put simply, it would be like trying to catch a mosquito with chicken wire.
The TGA also raised doubts about the integrity of samples tested because some had been used or opened, and risked outside (exogenous) DNA contamination.
Buckhaults was aware of these concerns, so he sourced unopened vials from 2023 and still found residual DNA that exceeded the permissible threshold, albeit lower than previous counts.
The TGA said that vaccine vials had to be shipped via ‘cold chain’ where the temperature is kept within a specified range and monitored during transportation.
But DNA is relatively stable and doesn’t require such careful storage, which is why forensic experts can extract DNA from dried blood after extended periods.
Conversely, the mRNA is less stable, which is why there was panic in 2020 about a shortage of ultra-cold freezers required to transport the vaccines across the country.
In fact, it was the TGA that decided it was no longer necessary to store and transport the mRNA vaccines at ‘ultra-freezing’ temperatures based on RNA stability data, which the agency insisted on keeping secret.
As indicated in my recent article about the residual DNA in the Gardasil HPV vaccine, regulators have known since the 1980s that products developed with recombinant technology are ‘expected’ to contain ‘small quantities’ of DNA remaining after processing and purification.
And they have always maintained it does not pose a risk to vaccine recipients.
The TGA says it follows international standards and permits 10 nanograms of residual DNA per dose. That threshold is based on historic experiments involving free or ‘naked DNA’ but in the case of mRNA vaccines, the residual DNA is not naked.
Lipid nanoparticles (fat globules), which encapsulate the mRNA, also capture the residual DNA in the vaccine, and purposefully ferry the genetic material straight into cells – a process called transfection.
As some readers may have read recently, lipid nanoparticles are not ‘essential’ for transfection.
My fellow substacker Dr Ah Kahn Syed expertly argued that residual DNA can enter cells, aided by other transfection agents in vaccines such as aluminium adjuvants or additives such as polysorbate, which can make cells more permeable.
The TGA maintains that “there has been no evidence of mRNA vaccines or biological medicines used in Australia resulting in integration of residual DNA into human DNA genome.”
But the plain truth is that the TGA has not looked. You cannot find, if you do not look.
It also claims that to date, “neither the TGA nor any international regulator has established a causal link between COVID-19 vaccines and any type of cancer.”
But the regulator did not demand any carcinogenicity or genotoxicity studies before the products were deployed on the population. And when asked for its post-marketing monitoring data on cancer rates, it denied the request.
Lastly, the TGA says it “constantly reviews the latest scientific evidence about the safety of vaccines.”
But when the TGA was asked to provide details about its investigation into the reported deaths following covid-19 vaccination, it turned a blind eye.
If the TGA wants to restore any semblance of public trust, it should release its data and put the story to rest.
The regulator simply cannot rely on the mantra that because there have been “more than 13 billion vaccine doses given worldwide” it must mean the vaccine is “safe and effective.”
UPDATE: OCT 20, 2024
Russell Broadbent, Member for Monash, who sent a letter co-signed by 52 academics, doctors and legal experts, urging the PM to “immediately suspend” the mRNA vaccines, has now published a Supplement to the Scientific Summary of Dr David Speicher, to address the recent TGA response.
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Another excellent article Maryanne. At the last count there were around a thousand comments on the TGA's tweet and every single one was negative. There has to be a tipping point where the TGA actually bother to reach out to "the other side" for help. Otherwise they are essentially admitting to knowingly committing criminal malfeasance. There is no justification for this level of head burying.
I can also reveal that they have a number of serious FOIAs in process that they are currently obfuscating or refusing and we even have an example of the TGA attempting to influence the requestor to retract their FOIA.
It should also be noted that the Australian people voted on a petition to parliament in September 2021 to release all documents for public funded medicines. The response from the health minister was that this is provided via FOI. The government is showing its contempt for the people with these responses.
The petition link is here for reference https://www.aph.gov.au/e-petitions/petition/EN3179 and the response here https://epetitions.aph.gov.au/api/ministerialresponse/download/EN3179
So Tony Lawyer from Tasmania replaced John Skerritt last year as Boss of TGA. Skerritt new life reported in your revolving doors article is now a board member alongside international big pharma colleagues from Pfizer Australia pty ltd, Merck etc on MEDICINES AUSTRALIA- lobbyist and big political donor (3rd largest at $244k in 2023)
Lawler is supposed to have clinical governance experience and been on the Australian Commission on Safety and quality in health care - DNA fragments in a provisionally approved mRNA VAX should be right up his street. Maybe that dratted funding by big pharma model interfered
Will we ever get independent Australian therapeutic goods evaluation.