Health Canada Responds to MP’s Questions on SV40 DNA Sequence in Pfizer Vaccine

The agency says the SV40 DNA sequence is a residual fragment in Pfizer’s COVID vaccines that is ‘inactive’ and has ‘no functional role.’

A health-care worker prepares a dose Pfizer/BioNTech COVID-19 vaccine at the Michener Institute in Toronto on Dec.14, 2020. Carlos Osorio/AFP via Getty Images

Health Canada has responded to a Conservative MP’s questions about a Simian Virus 40 (SV40) DNA sequence found in COVID-19 vaccines by continuing to assert the shots are safe.

MP Colin Carrie had submitted a series of questions on Oct. 27, a week after The Epoch Times published an article revealing that Health Canada had only recently become aware of the SV40 promotor-enhancer’s presence in the COVID-19 vaccines from Pfizer-BioNTech.

Some scientists say the DNA sequence has the potential to cause cancer, while others say it poses little to no threat.

In the Inquiry of Ministry tabled on Dec. 13, 2023, Health Canada responded that the SV40 promoter enhancer sequence was found to be a residual DNA fragment in the Pfizer COVID-19 vaccine.

“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,” the agency said.

Health Canada told The Epoch Times that while it expected sponsors to identify “any biologically functional DNA sequences within a plasmid (such as an SV40 enhancer) at the time of submission,” sponsors like Pfizer were only able to do so after scientists Kevin McKernan and Dr. Phillip J. Buckhaults revealed its presence in early 2023.

Following Health Canada’s confirmation, the European Medical Agency and the United States Food and Drug Administration (FDA) also acknowledged that the SV40 promoter-enhancer is present in the Pfizer COVID-19 injection.

The two scientists have expressed concern that the SV40 sequence—typically used as an enhancer to drive gene transcription during the vaccine manufacturing process—could inadvertently cause cancer in humans, a hypothesis that Health Canada has dismissed as “unfounded.”

Health Canada has declined to provide 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.

In his Inquiry of Ministry, Mr. Carrie also asked Health Canada if it had considered labelling the products as gene therapies. The agency responded that it did not because the shots cannot modify genes.

“Gene therapy involves the use of genes as medicine to treat genetic disease where the faulty gene is fixed, replaced, or supplemented with a healthy gene so that it can function normally,” said Health Canada. “The new gene has to enter the cell nucleus. The mRNA from the vaccines does not enter the cell nucleus or interact with the DNA at all, so it does not constitute gene therapy.”

The American Society of Gene and Cell Therapy (ASGCT) has said it classifies the mRNA injections as gene therapy because “the vaccine introduces new genetic material into cells for a short period of time to induce antibodies.” The organization also called the U.S. FDA’s approval of the Pfizer COVID-19 vaccine in December 2020 a “significant milestone for the field of gene and cell therapy.”

A study from the European Review for Medical and Pharmacological Sciences, published in December 2023, also found that when examining genomes in blood cells of people vaccinated for COVID-19, there was DNA altered with the genetic code of the Pfizer COVID-19 vaccine.

Plasmid DNA

Mr. Carrie also asked about the presence of plasmid DNA fragments in Pfizer COVID-19 vaccines, as well as the “amount of acceptable residual DNA per vaccine dose and the method used to measure it.” Mr. McKernan and Dr. Buckhaults had also revealed plasmid DNA in the COVID-19 vaccines, which is used in the manufacturing of mRNA vaccines but is supposed to be removed to meet a threshold set by health regulatory agencies before the final product is released for distribution.

Mr. McKernan had found the amount of DNA in the vaccines to be potentially 18 to 70 times higher than the limits set by one regulatory agency, and warned they could potentially integrate into the human genome.

Health Canada responded to Mr. Carrie’s question by saying it was aware of the presence of “residual plasmid DNA” in the vaccines, but that it was below its established limit of 10 nanograms per human dose.

“This is in line with the World Health Organization’s recommendation concerning residual DNA in biological drugs, and consistent with the quality limits of other international regulators,” the agency added.

When asked by Mr. Carrie if it would inform Canadians about the “adulteration of these products” by the SV40 sequence and the presence of plasmid DNA in order to “ensure fully informed consent,” Health Canada answered that it sets “high quality standards and requirements for manufacturers to follow,” which included detailed information about the vaccine manufacturing process.

“In the manufacture of any vaccine, it is expected that there may be variabilities or residual elements that are part of the standard manufacturing process,” Health Canada said, adding that it has strict quality limits and controls in place to ensure they are safe and that any residual fragments are inactive.

“All versions of the Pfizer and Moderna vaccines that have been marketed in Canada continue to meet the strict quality standards required by Health Canada. Health Canada takes immediate action should any marketed vaccine product be found to be non-compliant with regulatory standards in Canada.”