The U.S. Food and Drug Administration (FDA) will not recall Pfizer’s COVID-19 vaccine after a previously undisclosed oncogenic DNA sequence was identified in the company’s vaccine.
In an email to The Epoch Times, an FDA spokesperson said the agency isn’t required to remove Pfizer’s COVID-19 vaccine, or other COVID-19 vaccines, from the market.
“With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified,” the spokesperson said. “With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective.”
The FDA did not provide evidence to support its position, The Epoch Times reported. The news outlet asked the FDA 10 questions about the discovery of the Simian Virus 40 (SV40) DNA sequence found in Pfizer’s vaccine.
The polyomavirus simian virus 40 (SV40) is an oncogenic DNA virus known to induce brain and bone cancers, malignant mesothelioma, and lymphomas. The virus was initially derived from monkey kidney cell cultures used to make polio vaccines. According to the Centers for Disease Control and Prevention (CDC), 10% to 30% of polio vaccines, or 98 million doses, administered in the U.S. were contaminated with the SV40 virus.
SV40 is often used as an enhancer sequence in vaccines because it’s part of the plasmid used to replicate vaccine mRNA.
A plasmid is a small, extrachromosomal DNA molecule within a cell often found in bacteria or other microscopic organisms that are physically separated from chromosomal DNA and can replicate independently. Scientists use recombinant DNA methods to splice genes into a plasmid. When the plasmid copies itself, it also makes copies of the inserted gene.
Persuasive evidence has shown increased rates of ependymomas, osteogenic sarcomas, other bone tumors, and mesothelioma among those exposed to SV40 through contaminated polio vaccines.
Several foreign agencies, including Health Canada, have confirmed Pfizer’s COVID-19 vaccine contains the cancer-causing DNA sequence and that Pfizer did not inform regulators, but scientists Kevin McKernan and Dr. Phillip Buckhaults were the first to identify plasmid DNA in the shots and warned it could potentially alter the human genome.
According to Dr. Patrick Provost, a professor in the Department of Microbiology, Infectious Diseases and Immunology at the Faculty of Medicine at Laval University, the danger of the SV40 enhancers present in the vaccine is their possible integration into a cell’s DNA genome.
“All it takes is a single integration at the wrong place in a single cell to initiate a cancerous process and kill a person,” Provost said.
The SV40 enhancer could still be in the final product if the plasmid DNA is not sufficiently degraded by DNases that cut large DNA pieces into smaller ones.
Considering the average length of the degraded DNA fragments found by Buckhaults was 100 base pairs, and the SV40 enhancer sequence is only 72 base pairs long, the chance of finding an intact, fully functional SV40 enhancer sequence in mRNA vaccines is “relatively high, certainly not negligible.”
It is also possible that DNA fragments in the vaccines could encapsulate lipid nanoparticles, which could deliver SV40 directly into human cells.
Some experts suggest Pfizer’s failure to disclose the presence of SV40 to regulators and vaccine recipients constitutes willful misconduct—an exception to Pfizer’s blanket immunity from lawsuits.