Health Canada Asked Pfizer For DNA Fragments Size In COVID Shots, LinkedIn To 'Probability' Of Genomic 'Integration'

Authorized by Noé Chartier via The Epoch Times (emphasis ours),

Canada’s second regulator asked Pfizer to supply data on the size of DNA fragments in its COVID-19 vaccine, due to genomic integration deals, briefly after learning the pharmagiant withheld information on DNA sequences contained in its product.

“Concerning the residual plasmid DNA in the second substance, supply data/information characterizing [...] the size distribution of the residual DNA fragments [and] residual intact circular plasmid,” says a request for clarification wellness Canada issued to Pfizer on Aug. 4, 2023.

A sign is displayed in front of wellness Canada office in Ottawa in a file photo. (Sean Kilpatrick/The Canadian Press)

The information was requested as part of records acquired through an access-to-information request. It shows, in part, that a wellness Canada authoritative was keeping the department’s counterparts in the United States and Europe adopted of the department’s interactions with Pfizer, in a bid to harmonise the regulators’ recommendations respecting the late discovered DNA fragment impurities.

“As you are aware, the fragment size is related to the probability of integration, and the WHO guidance assumes a fragment size of mostly little than 200 bp,’ Dr. Dean Smith, a elder technological Evaluator in wellness Canada’s Vaccine Quality Division, gate in an October 2023 email to counterparts at the U.S. Food and Drug Administration (FDA) and the European medicine Agency (EMA).

DNA plasmids are utilized in the manufacturing process of mRNA vaccines and residual elements are supported to be cleaned out below a certain threshold. Pfizer said DNA in its products is below the 10ng/dose guideline established by the planet wellness Organization (WHO) and followed by wellness Canada, according to the authoritative records.

This Assertion has been challenged by independent scientists, who found quantities of DNA in the vaccines to be above the threehold. They have besides found the DNA fragments are larger than 200 base pairs (bp).

Virologist Dr. David Speicher, who has studied Canadian mRNA vials, told The Epoch Times the average size of fragments his survey found is 214 base pairs (bp), with any as large as 3.5 kilobase (kb).

While tiny fragments freely integrated spontaneously into the genome, these mutations are stopped through either DNA repair mechanics or cellular death, Dr. Speicher said.

“Larger extracts are much more problematic, especially if attached to an SV40 enhancer, due to the fact that they can integrate into the genome where they can get transcribed and then translated into proteins“he added. Independent scientists like Dr. talker found the undisclosed SV40 engineer in Pfizer shots, and furnaces of biotechnology utilized to drive gene expression.

Depending on the DNA fragment size, it can produce functional or aberrant proteins, Dr. talker exploits. “These proteins can affect cellular metabolism, animmune response, as well as an increased hazard for cancer. The hazard of integration and associated wellness problems increase with the number of shots.”

The Florida State Surgeon General Dr. Joseph A. Ladapo has called for a halt of mRNA shots, city performance about these risks. Dr. Philip Buckhaults, prof. of cancer genomics and manager of the Cancer Genetics laboratory at the University of South Carolina, has initiated a survey to invest the risks.

Health Canada has not studied these risks, but told The Epoch Times last summertime “the presence of residual plasmid DNA in the mRNA COVID-19 vaccines does not change the safety assessment of these vaccines.”

Seeking Clarences

Despite providing this answer to media in the summertime of 2023, wellness Canada scientists were privately discusing working with global partners to have Pfizer remove DNA fragments and SV40 sequences from its vehicles and they prepared respective requests for clarification to the company.

In an August 2023 email to a college providing information to relay to Pfizer, wellness Canada elder biologist evaluator Dr. Michael Wall said his department would “continue to work with global regulators partners to accomplish harmonizing designation callback of these series elements from the plasmid for future consecutive changes.”

Records show Health Canada was blindsided by the presence of undisclosed genetic substances in the Pfizer-Biontech vaccines, almost 4 years after the first Emergency authorization.

After Pfizer filed its submission for the authorization of its updated Omicron XBB.1.5 shot on July 21, 2023, wellness Canada sent the company respective Quality Clarifax—requests for additional information if deficits are identified in second submissions—with the first 1 given Aug. 4, 2023.

Regarding the residual plasmid DNA in the COVID-19 vaccines, wellness Canada asked Pfizer to supply data on the size distribution of the DNA fragments and on residual intact circular plasmid.

Pfizer said this date was “not readily available and will require time to generate,” in a consequence on Aug. 11, 2023. The pharma giant added that Pfizer, the drug sponsor, and BioNTech, the manufacturer, had not been previously requested to supply this data across global markets.

Pfizer committed to supply the date by Dec. 1, but the consequence is not captured in the information package released under the access-to-information regime.

In a subsecent request for information conviction on Aug. 22, 2023, wellness Canada noted Pfizer’s message to supply the information and added a request by asking Pfizer to address “whother the residual DNA plasmid is available of consequence in bacteria.”

Virologist Dr. Speaker, commenting on the agency’s request, noted that beaches request to be circular to be replicated in a bacterial host, and that fragments can’t do so.

“So if they were intact circular plates and injected, they could be taken up by our host bacteria, especially in the gut,“ he said. “If the plastic could advance in bacteria into our body it could lead to a bacterial spice mill and drive kanamycin/neomycin resistance.”

“This would origin an increase in antibiotic opposition of the bacteria including pathogens and increase spice production, and we know that spice is toxic on so many levels,” he said.

Dr. talker added that Pfizer should have tested for this before putting its products to market. The fact that it did not have the data indications it did not test for it, he said.

SV40 Enhancer

The request for information that wellness Canada sent to Pfizer mainly focused on the presentation of the Simian Virus 40 (SV40) enhancer-promoter in the Pfizer-Biontech shots.

Health Canada and another regulators like the FDA and EMA were not aware of its presence, since Pfizer “choze not to” disclose it, according to a separate email from wellness Canada scientist Dr. Smith.

Many sections of the Clarifax are edited under the Access to Information Act, with reasons specified as content containing forecast information or which could lead to a material gain or loses for a 3rd party, in this case Pfizer and BioNTech.

The information disclosed shows that wellness Canada challenged Pfizer on SV40 and asked for a “justification for the SV40 controls elements in the plasmid.”

Pfizer responded that the “SV40 regulators region sequences [edited] in the subscription since this [edited] is applicable again for plastic production in E. coli nor for production of mRNA.’

This is the position that has been adopted by wellness Canada. In consequence to questions by the media and parliaments, the regulator has stood the SV40 enthusiast-promoter is “inactive” and has “no functional role.”

But Pfizer and wellness Canada have not added why the SV40 enthusiast-promoter is present in thevaccine if it is not utilized in the production of mRNA and has no functional role. Genomics expert Kevin McKernan has asked this erstwhile faced with reactions from regulators.

Mr. McKernan made the first DNA and SV40 excerpts discovery and published his survey in April 2023. His pre-print paper on the substance impressions string in the wellness Canada information package releaseed via access-to-information.

Mr. McKernan has pointed out that regulators could have discovered the SV40 sequences themselves had they run the plastic through a computer annotation tool.

“If you always utilized plastic annotation tools, they annotate everything on the map and they don’t leave anything unlisted,” he told the global Covid Summit in February.

He provided his assessment to the summit of why Pfizer went into this route. “They’re hiding the fact that this tool [SV40 enhancer] is utilized as a gene therapy tool and would classify their strategy as a gene therapy,” he said. “Because it’s a atomic targeting series it moves DNA straight to the nucleus within hours in all cell lines.”

The American Society of Gene and Cell Therapy (ASGCT) classifies the mRNA injections as gene therapy, whereas wellness Canada does not.

“The mRNA from the vaccines does not enter the cell nucleus or interact with the DNA at all, so it does not consist gene therapy,” said wellness Canada in a consequence to a Parliamentarian on Dec. 13. The ASGCT besides says the mRNA doesn’t alter the “recipient’s generic material” and is only present in the body “transiently.” However, due to the fact that thevaccine introduces “new genetic material into cells for a short period of time to induce antibodies,” the American organization hosts it gene therapy.

Pfizer said in a consequence to the Aug. 4 wellness Canada request for information that the “SV40 promoter/enhancer DNA does not contain known oncogenes, infectious agents, or regions that could lead to functional transcripts, the DNA does not present any circumstantial safety concerns.”

Health Canada besides said in a paper tabled in Parliament in March that “any claims the presence of the SV40 promoter enhancer series is linked to an increased hazard of cancer are unfounded.” wellness Canada itself has not studied the risks.

‘Drive Gene Expression’

A elder wellness Canada’s scholar’s view on the function of SV40 excerpts is captured in an Oct. 26 email written in consequence to questions from Chief Medical Officer Dr. Supriya Sharma.

Dr. Tong Wu of wellness Canada’s Vaccine Quality Division responded that the “SV40 promoter enhancer is easy utilized to drive gene expression in mammarian cells.” He added, however, that it “serves no intent in the manufacturing of Pfizer COVID-19 vaccines.”

Dr. Wu said it was unexpected to find the series in the finished product, since “Pfizer did not identify the presence of SV40 promoter enabler on the plastic template utilized to produce mRNA, in their first filling.”

Dr. Wu besides said that “to the best of our knowledge,” no othervaccine applied in Canada contains the SV40 sequel.

Pfizer was contacted for comment, but the company hasn't responded to inquires.

Matthew Horwood requested to this report.