Dr. Joseph Ladapo says the study found the number of DNA molecules per vaccine dose exceeds the guidelines set forth by the FDA and the WHO.
Florida’s Surgeon General is warning against using mRNA COVID-19 vaccines amid concern about potential links to cancer, citing a Canadian study that found the presence of DNA fragments within Pfizer and Moderna vaccines.
In a Jan. 3
statement explaining his rationale, Dr. Joseph Ladapo included a link to
Canadian pre-print study which discovered billions of DNA molecules per vaccine dose, which exceeds the guidelines set forth by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO).
“DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients,” said Dr. Ladapo.
He also cited a 2007 FDA report that said DNA integration could theoretically impact oncogenes—the genes that can transform a healthy cell into a cancerous cell.
“If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings,” he said.
Dr. Ladapo sent a
letter to the United States Food and Drug Administration (FDA) and Centers for Disease Control and Prevention on Dec. 6, regarding the COVID-19 vaccine safety assessments and the discovery of billions of DNA fragments per dose in the vaccines. Plasmid DNA is used in the manufacturing of mRNA vaccines and is supposed to have a level below the threshold set by health regulatory agencies before the final product is released for distribution.
The FDA provided a
response on Dec. 14 with no evidence that DNA integration assessments had been conducted, instead pointing to genotoxicity studies—studies that Dr. Ladapo said are “inadequate assessments for DNA integration risk.”
The FDA said it is “confident in the quality, safety, and effectiveness of the COVID-19 vaccines based on a thorough assessment of the manufacturing process.”
Plasmid DNA
The lead author of the Canadian study, molecular virologist and clinical epidemiologist Dr. David Speicher from the University of Guelph, said Dr. Ladapo’s statement is “encouraging” and “courageous.” It’s an “honour to know that our study was instrumental in making that decision,” he told The Epoch Times.“The SV40 enhancer-promoter in the Pfizer vaccines is a risk for genomic integration as well as interfering with the p53 gene (the guardian of the genome). Both could drive an increase risk for cancer,” he said in an email.
Dr. Speicher noted his study confirmed previous reports by microbiologist Kevin McKernan and professor of cancer genomics Dr. Philip Buckhaults, who examined COVID-19 mRNA products and found residual plasmid DNA.
Mr. McKernan, who contributed with Dr. Speicher on the Canadian pre-print, previously found the amount of DNA in the vaccines to be potentially 18 to 70 times higher than the
limits set by the European Medicines Agency.
Health Canada says it was aware of the presence of residual plasmid DNA in the vaccines as a “process-related impurity during review and prior to the authorization of the mRNA COVID-19 vaccines.”
The agency said while it could not fully review the testing methods used by the manufacturer, given that they are proprietary information, “the methods used for measuring residual DNA fragments were appropriately validated by the manufacturer and evaluated as fit for purpose by Health Canada.”
SV40 Promoter
Dr. Ladapo also cited concerns with the Simian Virus 40 (SV40) promoter/enhancer DNA present in the COVID-19 vaccines, claiming it may pose a “unique and heightened risk of DNA integration into human cells.” He said the FDA’s response on the matter “obfuscated the difference between the SV40 promoter/enhancer and SV40 proteins, two elements that are distinct.”The SV40 virus was previously removed from polio vaccines in the late 1950s and early 1960s due to concerns about its link to cancer. The SV40 promoter, which uses a small piece from the virus, is present in Pfizer COVID-19 vaccines to amplify the mRNA.
Health Canada
said while it expected all sponsors to identify any “biologically functional DNA sequences within a plasmid” when they submit drugs to be reviewed, Pfizer did not explicitly identify the SV40 sequence. The agency said that the fragment is “inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators,” adding that the risk/benefit profile ”continues to support the use of the Pfizer-BioNTech vaccine.”
Health Canada also dismissed concerns about the SV40 promoter inadvertently causing cancer, calling the worries “unfounded.” The agency has
declined to provide the Epoch Times with its risk assessment to support its statement, as well as examples of studies assessing the risk of cancer in vaccines related to the SV40 sequence.
Editor’s note: This article was updated on Jan. 5 to add comments from David Speicher, the Canadian study’s lead author.
