Over the last two years, cancer genomic experts have raised concerns about the presence of residual DNA fragments in the mRNA COVID-19 vaccines, saying that it has the potential to increase the risk of developing cancer.
This mirrors the concerns raised several years ago about the safety of the Gardasil human papillomavirus (HPV) vaccine, manufactured by Merck & Co.
In 2011, Sin Hang Lee, a pathologist and 30-year veteran in DNA analysis, made the startling discovery of synthetic DNA fragments in several vials.
“I was shocked to find DNA fragments in the HPV vaccine because DNA is not supposed to be there,” Lee recalls.
“They use DNA to make the vaccine, but then it is supposed to be chopped up and removed in the manufacturing process,” he said.
Lee, an internationally recognized expert in molecular gene detection, carefully documented his findings in a report that was sent to the U.S. Food and Drug Administration (FDA) for review.
The FDA investigated.
On Sept. 23, 2011, the FDA’s Center for Biological Evaluation and Research (CEBR) responded by saying it had evaluated the concerns in Lee’s report, and determined that the Gardasil vaccine was “safe and effective.”
The FDA did acknowledge that Lee found residual DNA in the vaccine, but said it was “expected” and “inevitable” in products that are manufactured using recombinant technology.
The agency also said it remained confident that the residual DNA was “not a risk to vaccine recipients.”
“The presence of residual DNA is not a safety factor as defined by US regulations, and is not required to be included in Gardasil’s labeling,” wrote the FDA.
The following month (Oct. 21, 2011) the FDA quietly updated its website to reflect the presence of DNA fragments in the vaccine, assuring the public there was “no safety risk.”
“It was really disappointing,” said Lee.
“The FDA claimed that the presence of DNA fragments was not a problem without showing any studies to prove it had been investigated or that it was safe,” he added.
The European Medicines Agency was also notified of the problem and its response was the same, stating, “the presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients.”
The following year, Sin Hang Lee published his findings in the Journal of Inorganic Biochemistry.
An accidental discovery
HPV is a virus primarily transmitted through sexual contact and is the main cause of cervical cancer. Authorities have predicted the widespread use of the HPV vaccine will “eliminate” cervical cancer by 2030.
In 2006, when Gardasil was first approved, Merck assured the FDA there was no HPV DNA in the vaccine. But this was challenged when Lee found HPV DNA in someone who had never been exposed to the HPV virus.
It all began when a 13-year-old girl from Toronto developed acute juvenile rheumatoid arthritis within days of receiving her third dose of Gardasil. A battery of tests revealed the young girl tested positive for HPV DNA in her blood by PCR.
It was a mystery to her doctors because she was sexually naïve and had never been exposed to the virus.
Her parents wondered if the viral DNA in her blood could have originated from the Gardasil vaccine itself. They reached out to an advocacy group that organized for vials of the Gardasil vaccine to be tested.
Lee received 13 vials from nine different countries and found every single one of them contained fragments of HPV DNA.
In 2012, Lee testified at a coronial inquest into the death of 18-year-old New Zealander Jasmine Renata, who died unexpectedly in her sleep, six months after receiving her third Gardasil injection.
Post-mortem tissue samples were sent to Lee for testing. The blood and spleen were positive for HPV DNA, which Lee said, was not the result of a natural HPV infection.
“It’s not ‘natural’ HPV DNA and its detection six months after injection is not normal,” he told the inquest, though he could not say with certainty if the vaccine caused her death.
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Measuring residual DNA in Gardasil
Since the 1980s, a number of studies have raised potential safety concerns about residual DNA in vaccines and viewed the fragments as “impurities” that needed to be eliminated.
But the permissible limit of residual DNA in vaccines has significantly increased.
In 1985, the FDA set an upper limit of 10 picograms per dose. In 1987, the World Health Organization increased its recommended limit to 100 picograms and then increased it again to 10 nanograms (i.e., 100 times higher) — a limit now adopted by the FDA.
Lee says it’s difficult to quantify the levels in Gardasil though, because the HPV DNA is tightly bound to the aluminium adjuvant (AAHS) and forms an insoluble precipitate.
“My expertise is being able to detect the HPV L1 gene DNA in the insoluble precipitate, as well as the soluble DNA in the solution, using a technique called nested PCR with Sanger sequencing for confirmation,” explained Lee.
Genomics expert Kevin McKernan, who was the first to discover residual DNA in Pfizer’s COVID-19 vaccine, attests to Lee’s expertise. He agreed that the FDA’s permissible limit of 10 nanograms is futile in this case.
“That’s the trick the FDA is playing with the guidelines,” said McKernan. “When you go to measure the residual DNA, you’ll miss the majority of it because it is all bound up to the aluminum adjuvant.”
“The 10 nanogram limit they’ve come up with is just smoke and mirrors. They say if it’s below that, then they don’t care, but here you have something that hides the DNA in aluminum, and they just whistle past the graveyard,” said McKernan.
Potential risks of HPV DNA in Gardasil
Based on Lee’s post-mortem analyzes, we know that HPV DNA fragments in the Gardasil vaccine find their way to blood, brain and spleen after injection into the deltoid muscle of the arm. But what are the consequences?
Innate immune system theory
Lee suggests the HPV DNA fragments in the vaccine are taken up by immune cells such as macrophages, and then travel through the lymphatic system where they deposit in various tissues throughout the body.
It is theorized that here, the HPV DNA which is tightly bound to the aluminum adjuvant and does not break down easily, can cause chronic immune-inflammatory reactions that lead to autoimmune conditions in some people.
Incidentally, Merck is facing multiple lawsuits by people who claim they developed autoimmune conditions such as postural orthostatic tachycardia syndrome (POTS), neurological issues or premature ovarian failure from Gardasil.
Genome integration theory
Another theoretical risk is if residual fragments of HPV DNA in the vaccine enter cells and integrate with the host DNA.
This has been the concern with the residual DNA fragments found in COVID-19 mRNA vaccines, where lipid nanoparticles ferry the mRNA — along with residual DNA fragments — into the host cell and potentially integrate into the human genome.
Phillip Buckhaults, a cancer genomics expert at the University of South Carolina, testified before a Senate Committee about his concerns that fragments of foreign DNA in the COVID-19 mRNA vaccines can insert themselves into a person’s genome and become a “permanent fixture of the cell.”
At this stage, there is no evidence this occurs with Gardasil and no studies have ever been conducted to see if fragments of HPV DNA in the Gardasil vaccine can integrate into the genome and disrupt vital genes.
Also, it would require the presence of a “transfection agent” in the vaccine i.e. something that enables exogenous genetic material (DNA or RNA) to enter human cells. Some studies suggest that adjuvants themselves can act as transfection agents.
Whatever the case, the discovery of HPV DNA fragments in Gardasil and their detection in post-mortem tissues sometime after vaccination raises important questions about the safety testing of residual DNA fragments in all vaccines developed with recombinant technology.
Originally published on Maryanne Demasi’s Substack page.
