Early in 2023, genomics scientist Kevin McKernan made an accidental discovery. While running an experiment in his Boston lab, McKernan used some vials of mRNA Pfizer and Moderna Covid vaccines as controls. He was ‘shocked’ to find that they were allegedly contaminated with tiny fragments of plasmid DNA.
McKernan, who has 25 years’ experience in his field, ran the experiment again, confirming that the vials contained up to, in his opinion, 18-70 times more DNA contamination than the legal limits allowed by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
In particular, McKernan was alarmed to find the presence of an SV40 promoter in the Pfizer vaccine vials. This is a sequence that is, ‘…used to drive DNA into the nucleus, especially in gene therapies,’ McKernan explains. This is something that regulatory agencies around the world have specifically said is not possible with the mRNA vaccines.
Knowing that the contamination had not been disclosed by the manufacturers during the regulatory process, McKernan raised the alarm, posting his findings to Twitter (now X) and Substack with a call-out to other scientists to see if they could replicate his findings.
Other scientists soon confirmed McKernan’s findings, though the amount of DNA contamination was variable, suggesting inconsistency of vial contents depending on batch lots. One of these scientists was cancer genomics expert Dr Phillip Buckhaults, who is a proponent of the mRNA platform and has received the Pfizer Covid vaccine himself.
In September of this year, Dr Buckhaults shared his findings in South Carolina Senate hearing. ‘I’m kind of alarmed about this DNA being in the vaccine – it’s different from RNA, because it can be permanent,’ he told those present.
‘There is a very real hazard,’ he said, that the contaminant DNA fragments will integrate with a person’s genome and become a ‘permanent fixture of the cell’ leading to autoimmune problems and cancers in some people who have had the vaccinations. He also noted that these genome changes can ‘last for generations’.
Dr Buckhaults alleges that the presence of high levels of contaminant DNA in the mRNA vaccines ‘may be causing some of the rare but serious side effects, like death from cardiac arrest’. He added, ‘I think this is a real serious regulatory oversight that happened at the federal level.’
Dr Buckhaults’ concerns are shared by McKernan, who presented his findings to the FDA in June. At the time of writing, McKernan had not received any response from the FDA on the matter. Dr Buckhaults said in the Senate hearing that he had emailed his findings to the FDA, but he had not received a response either.
In Australia, the Therapeutic Goods Administration (TGA) maintains that Covid vaccines cannot alter a person’s DNA. A spokesperson for the TGA stated, ‘The mRNA in the vaccines does not enter the nucleus of cells and is not integrated into the human genome. Thus, the mRNA does not cause genetic damage or affect the offspring of vaccinated individuals.’
They also said, ‘All batches of Covid vaccines distributed to Australians have been tested for the presence of contaminants including residual DNA template levels.’
However, a legal case filed in the Australian Federal Court in July of this year alleges that the TGA is not the appropriate regulator of COVID mRNA vaccines because, under the Gene Technology Act (2000) definition, DNA contamination is a genetically modified organism (GMO).
The plaintiff, Victorian doctor and pharmacist Dr Julian Fidge, is seeking an injunction to stop Pfizer and Moderna from distributing their mRNA Covid vaccines because they never obtained a license from the Office of the Gene Technology Regulator (OGTR), which is the agency that oversees all GMO related products.
The TGA did not require tests for genotoxicity or carcinogenicity before providing provisional approval and, eventually, full registration of both the Moderna and Pfizer Covid vaccines. OGTR guidance strongly suggests such tests should be undertaken where there exists a risk of harm to human health.
McKernan, who provided expert advice on the case, agrees that the DNA contamination in the mRNA vaccines fits the Australian legal definition of a GMO. But there is also a second component of the mRNA vaccines that fits the definition.
That’s the mRNA itself, which is actually modified RNA wrapped in lipid nanoparticles (LNPs). The case argues that this ‘LNP-mod-RNA complex’ falls under the legal definition of a GMO and that, like the DNA contamination, it has the capacity to enter the cell nucleus and integrate into the human genome.
There is already at least one peer-reviewed scientific paper demonstrating that the Pfizer Covid vaccine mRNA can enter the human liver cell line and reverse transcribe into DNA in vitro (meaning in a lab dish).
Other studies cited in the case materials show the presence of spike protein mRNA in the nucleus of human cells, and evidence that acquired immune traits pass down to the offspring of mice pre-exposed to the Covid vaccine mRNA-LNP platform. This is suggestive that, once in the nucleus, the vaccine mRNA can be transferred and integrated with chromosomal DNA.
Taking both the LNP-mod-RNA complexes and the recently discovered DNA contamination present in the mRNA Covid vaccines, acting solicitor Katie Ashby Koppens says, ‘Every single person who has been injected with these products has received a GMO that has not been through the expert regulatory process in this country.’ She adds, ‘The human genome could be changed permanently, and no one was informed.’
Now, McKernan, Dr Buckhaults and other scientists are calling for urgent research to test whether the DNA contamination is lingering in the cells of mRNA vaccinated people, and whether the human genome has in fact been altered by mRNA Covid vaccines.
