The Therapeutic Goods Administration (TGA) has finally released its much-anticipated data on the levels of residual DNA in Comirnaty (Pfizer) and Spikevax (Moderna) COVID-19 vaccines.
The findings were meant to end months of speculation surrounding the safety of the mRNA vaccines, but instead they have raised more questions than answers.
After independent testing found excessive levels of residual DNA in vaccine batches from the U.S., Canada, Australia and Germany, experts have been concerned the products could increase the risk of cancer.
In September, Australian Prime Minister Anthony Albanese was urged to “immediately suspend” the vaccines and adopt a “precautionary approach” in lieu of further safety testing.
But the prime minister dismissed the concerns, pointing to the TGA’s webpage that claims it is all “misinformation.”
The TGA denied there were excessive levels of residual DNA in the vaccines and said it had independently tested multiple batches that “met the required limits for residual DNA.”
But the TGA did not present those data — until now.
They tested 13 batches of Moderna’s product and 15 batches of Pfizer’s product. The level of residual DNA ranged from 0.04 to 5.56 nanograms (ng) per dose.
The report concluded that all 28 batches “complied with the World Health Organization recommended limit of up to 10 ng per dose.”
However, several concerns remain.
FIRST, the TGA confirmed that “residual DNA testing commenced in late 2023 using samples of all batches available for distribution within Australia at that time.”
That means the TGA did not investigate this issue until it was raised as a concern by the public, and by this time, the majority of Australians had already received two or three doses.
SECOND, the expiration dates on the batches ranged from Dec. 5, 2023, to Sept. 30, 2025.
None of the batches tested by the TGA were registered prior to 2023 and therefore did not represent those batches used to inoculate the majority of Australians.
Independent scientists have already determined that recent batches contain less residual DNA than earlier batches.
Philip Buckhaults, a cancer genome expert and professor at the University of South Carolina found Pfizer vials from 2023 had about 10 times less residual DNA than vials from 2020.
THIRD, the TGA used methods that were likely to “under-estimate levels by 100 times,” according to Kevin McKernan, the genomics expert who first blew the lid off this scandal last year.
It used quantitative PCR (qPCR) to find a small gene (Kan R gene) on the starting plasmid DNA which, once digested by enzymes into a billion pieces, is like trying to find the proverbial needle in the haystack.
FOURTH, the TGA does not address the clinical safety of having even small amounts of plasmid DNA in the products.
The 10 ng threshold was established for traditional vaccines that do not use “transfecting agents” like lipid nanoparticles, which encapsulate genetic material and ferry it inside cells.
The fact is, there are still no data on the clinical safety of even small amounts of exogenous plasmid DNA getting inside cells (or to the nucleus) with the help of lipid nanoparticles. And none of the regulators demanded carcinogenicity or genotoxicity studies prior to approving the products.
The TGA was asked to confirm if it had done any safety testing of residual plasmid DNA in the context of lipid nanoparticles, but the agency said the question was “complex” and that it could take “up to 20 working days to receive a response.”
NB: All batches were also tested for bacterial endotoxin content by the TGA Laboratories and found to comply with the allowed limits.
Originally published on Maryanne Demasi’s Substack page.
