Lack of ‘Straight Answers’ From Health Canada on COVID Vaccines Is Concerning, Tory MP Says

A sign is displayed in front of Health Canada headquarters in Ottawa on Jan. 3, 2014. The Canadian Press/Sean Kilpatrick

A Conservative MP trying to get answers about the COVID-19 vaccines has received only partial responses from Health Canada, including to questions about the presence of a Simian Virus 40 DNA sequence in the Pfizer-BioNTech product.

“Canadians were looking for straight answers during the pandemic in order to make important informed decisions, not only about their health, but the health of their kids,” Tory MP Colin Carrie told The Epoch Times in an interview. “When they give you these word salads back, what I’m concerned about is Canadians’ trust in our institutions.”

Mr. Carrie filed his second order paper with the government on Feb. 5 to obtain answers about the Simian Virus 40 (SV40) enhancer sequence in Pfizer’s mRNA shot. Health Canada responded on March 22.

The MP had questioned whether Health Canada had asked Pfizer about the safety of the SV40 sequence or how it knows the SV40 fragments are inactive and have no functional roles in mRNA vaccines. He was following up on Health Canada’s response in December to his previous SV40-related questions.

The regulator did not directly answer, nor did it say whether it had itself verified the amount of “SV40 enhancer promoter sequence and SV40 poly(A)tail signal sequence” in the shots.

Health Canada’s response in December suggests it doesn’t perform tests on its own, but rather relies on manufacturer data.

“It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies,” said Health Canada.

The regulator also stressed that the whole SV40 virus is not present in Pfizer’s COVID-19 vaccine, only a sequence or fragment.

Undisclosed Presence

Pfizer had not disclosed the presence of the SV40 sequence to government regulators like Health Canada, as The Epoch Times first reported in October.

Health Canada says Pfizer confirmed the presence of the SV40 sequences on Aug. 9 after the regulator had sent clarification requests during its review of Pfizer’s submission for its COMIRNATY Omicron XBB.1.5 shot. That is almost three years after Pfizer’s product targeting the initial SARS-CoV-2 variant was authorized in late 2020.

Health Canada spokesperson Anna Madison told The Epoch Times her department sent clarification requests on Aug. 4 and Aug 22. She said the requests and responses received cannot be disclosed because they contain proprietary information.

The Epoch Times began making inquiries with Health Canada about DNA contamination a few weeks earlier, on July 17, and about SV40 on July 19. In response, Health Canada said Pfizer had not identified the SV40 sequence but that Health Canada was able to confirm its presence after American scientists Kevin McKernan and Dr. Philip Buckhaults publicized the issue.

Health Canada has since taken the position that the SV40 enhancer, which it calls a “residual DNA fragment,” is “inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators.”

“Residual elements that are part of the standard manufacturing process” of any vaccine “may remain,” it said.

“There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine,” it said.

‘Risk of DNA Contaminants’

That view has been questioned by some scientists, including the one who made the initial DNA discovery in April 2023.

Mr. McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project, found the amount of DNA in the vaccines to be higher than the guidelines set by the European Medicines Agency and the U.S. Food and Drug Administration.

Mr. McKernan’s findings have been replicated by other scientists, including in a Canadian study led by Dr. David Speicher published in October.

The SV40 enhancer is used in the manufacturing process as a component of the plasmid to amplify the mRNA.

Concerns are that the leftover DNA from the process, encased into lipid nanoparticles, could enter the cell nucleus and modify the human genome through integration and/or promote the development of cancers.

Conservative MP Colin Carrie rises in the House of Commons in Ottawa on May 6, 2016. The Canadian Press/Adrian Wyld

Mr. Carrie asked Health Canada for its “official position with respect to the increased risk of DNA contaminants getting into human cells, including the cell nucleus, when encapsuled in liposomes, as is the case with the mRNA vaccines.”

Health Canada responded that Pfizer-BioNTech’s vaccine is safe and effective, repeating previous statements from its response about the SV40 fragment being non-functional and below the regulatory threshold.

The regulator also added, unprompted, that “any claims that the presence of the SV40 promoter enhancer sequence is linked to an increased risk of cancer are unfounded.”

Dr. Buckhaults, a professor of cancer genomics and director of the Cancer Genetics Lab at the University of South Carolina, previously told The Epoch Times the “little piece” of SV40 DNA poses a small but “non-zero future cancer risk, same as all the other DNA sequences” found in the shots. The scientist announced in late January he would begin research to discover if there is genomic integration of the vaccine mRNA.

Integration

Mr. Carrie asked Health Canada about the integration issue after the regulator said in December that mRNA products cannot modify genes.

“The mRNA from the vaccines does not enter the cell nucleus or interact with the DNA at all,” wrote Health Canada.

Mr. Carrie followed up by asking how Health Canada had “confirmed with certitude there is no genetic integration (i.e. in vivo transfection into the nucleus of human cells) of DNA plasmid fragments, which may or may not contain SV40 sequences.”

Health Canada did not respond directly and instead referred to a previous answer that didn’t contain information about potential integration per se but shoots down cancer concerns.

In-vitro DNA integration of mRNA vaccines via reverse transcription was previously demonstrated by Swedish scientists in a study published in February 2022.

Mr. McKernan stated in his April 2023 pre-print on the presence of DNA in mRNA vaccines that his work has not shown evidence of genomic integration. However, he said the reverse transcription process for integration would not be necessary to achieve integration “given the dsDNA levels in these vaccines.”

Mr. Carrie also asked Health Canada if the previously undisclosed presence of SV40 sequences “or any other adulteration” such as reverse open reading frames (ORF) violates the terms of contracts with manufacturers. Open reading frames are spans of DNA sequence that have the potential to be translated into a protein.

“Publicly undisclosed presence of residual SV40 sequences would not violate the terms and conditions of the Pfizer contracts, as the presence of residual SV40 sequences do not change the benefit-risk ratio for this vaccine,” said Health Canada.

Frameshifting

Along with DNA contamination issues, recent research indicates mRNA injections, which coach the cells to produce the SARS-CoV-2 spike protein, may generate approximately 8 percent of unintended additional proteins. This process is called frameshifting.

The Epoch Times previously reported that Health Canada officials deleted a comment from an in-house scientist saying that amount constitutes a “high level of impurity,” in an assessment on frameshifting destined for chief medical adviser Dr. Supriya Sharma.

Some scientists are concerned the production of intended proteins could cause autoimmune diseases.

Frameshifting could lead to the “inappropriate induction of potent immune responses that can lead to autoimmune conditions that can be life-altering at best, and life-threatening at worst,” immunologist and public health researcher Dr. Jessica Rose previously told The Epoch Times.

Meanwhile a news article published in Science magazine discussing the discovery has downplayed concerns, saying there’s no evidence of harm.

Informed Consent

MP Colin Carrie, who served as parliamentary secretary to the health minister from 2008 to 2013 under the Stephen Harper government, said these various issues with the vaccines raise concerns about informed consent and Health Canada’s role as regulator.

He says Canadians “still don’t even have full disclosure with respect to what’s in these mRNA products and the potential adverse events, so where is the informed consent?”

The MP, a former chiropractor, suggested that Health Canada would normally pull a natural health product off the market if it found something not disclosed by the manufacturer.

Had the presence of the SV40 sequence in the injections been disclosed, “you might have had a different uptake” by Canadians, he said.

Matthew Horwood contributed to this report.