Health Canada has claimed mRNA COVID-19 vaccine supplier Pfizer made a conscious decision not to inform institutions jabs contain Simian Virus 40 (SV40) DNA sequence. SV40 is an “emerging human pathogen” that “induces cancer,” according to the US National Institutes of Health (NIH) and the US Food and Drugs Administration (FDA). The sequence was linked to cancer after it was discovered in patients who had received the Polio vaccine in the late 1950s. It was promptly removed from the treatment. “DNA integration could theoretically impact a human’s oncogenes, the genes which can transform a healthy cell into a cancerous cell,” the FDA wrote in 2007. Pfizer, alongside governments — including Prime Minister Justin Trudeau and the Liberal party — urged the public to consume the vaccine, stating the procedure is “safe and effective.” The Epoch Times this week published screenshots of emails from a top Public Health Agency of Canada (PHAC) official confirming Pfizer was aware of the contamination but neglected to inform regulators, such as PHAC. International regulators such as the FDA and the European Medicines Agency (EMA) had the same experience of Pfizer withholding the important detail, according to access to information requests obtained by the publication. Yet the FDA said January 3 it had not identified any “safety concerns related to the sequence of, or amount of, residual DNA,” per the New York Times.Two weeks after PHAC confirmed the presence of SV40, which had been made public through the work of US scientists Dr. Kevin McKernan and Dr. Phillip J. Buckhaults in April 2023, the agency’s Dean Smith, a senior scientific evaluator in the Vaccine Quality Division, wrote an August 23 2023 email to an FDA colleague regarding certain “questions coming to agencies.”“I understand that there have been internal discussions at CBER (Center for Biologics Evaluation and Research) regarding the (presence) of an SV40 enhancer/promoter sequence, noting that its presence is unrelated to the purpose of the Pfizer’s plasmid as a transcription template for their mRNA COVID-19 vaccine,” wrote Smith. “Pfizer has communicated to us recently, that they apparently chose not to mention this information to EMA, FDA or HC at the time of their initial or subsequent submissions.”.The agency was willing to confirm the presence of SV40 only after McKernan and Buckhaults, who warned the plasmid DNA could affect the human genome, raised the issue publicly. McKernan, whose field of expertise is genomics, discovered the quantity of DNA (SV40) in the mRNA shots was higher than the threshold set by regulatory agencies. Health Canada in October confirmed with the Epoch Times the DNA plasmid, which is allegedly used to amplify the mRNA technology, is found in the vaccines. The agency, however, claimed it doesn’t mean the vaccines aren’t safe, because the body breaks it down. Now that it's been made known publicly (through McKernan and Buckhaults), it is “possible for Health Canada to confirm the presence of the enhancer based on the plasmid DNA sequence submitted by Pfizer against the published SV40 enhancer sequence,” wrote PHAC.“Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid (such as an SV40 enhancer) at the time of submission. Although the full DNA sequence of the Pfizer plasmid was provided at the time of initial filing, the sponsor did not specifically identify the SV40 sequence."“The residual plasmid DNA is present in the final product as DNA fragments, due to the enzyme digestion step in the downstream process,” the email response from Health Canada added. “As such, the original risk benefit analysis that supported the initial approval of the Pfizer vaccine continues to be valid.” “Health Canada does not rely on the conclusions provided by vaccine manufacturers. Health Canada conducts an in-depth independent review of the required evidence provided by the manufacturer to ensure that our high standards for safety, efficacy and quality are met.”.In 2007, the FDA published “guidance on regulatory limits for DNA vaccines”, according to the Florida Health website, outlining “important considerations for vaccines that use novel methods of delivery regarding DNA integration.” “DNA integration may result in chromosomal instability” and “affect unintended parts of the body including blood, heart, brain, liver, kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, and the site of administration and subcutis at injection site," the FDA found. “The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk of DNA integration into human cells." In 2022 Pfizer grossed US$37.8 billion for the mRNA COVID-19 vaccines, per data published in 2023 by CNBC, an increase of 3% from 2021. In October 2023, the US Securities and Exchange Commission noted the pharmaceutical giant's projected revenues for 2023 had been revised due to COVID-related sales tapering off.
Health Canada has claimed mRNA COVID-19 vaccine supplier Pfizer made a conscious decision not to inform institutions jabs contain Simian Virus 40 (SV40) DNA sequence. SV40 is an “emerging human pathogen” that “induces cancer,” according to the US National Institutes of Health (NIH) and the US Food and Drugs Administration (FDA). The sequence was linked to cancer after it was discovered in patients who had received the Polio vaccine in the late 1950s. It was promptly removed from the treatment. “DNA integration could theoretically impact a human’s oncogenes, the genes which can transform a healthy cell into a cancerous cell,” the FDA wrote in 2007. Pfizer, alongside governments — including Prime Minister Justin Trudeau and the Liberal party — urged the public to consume the vaccine, stating the procedure is “safe and effective.” The Epoch Times this week published screenshots of emails from a top Public Health Agency of Canada (PHAC) official confirming Pfizer was aware of the contamination but neglected to inform regulators, such as PHAC. International regulators such as the FDA and the European Medicines Agency (EMA) had the same experience of Pfizer withholding the important detail, according to access to information requests obtained by the publication. Yet the FDA said January 3 it had not identified any “safety concerns related to the sequence of, or amount of, residual DNA,” per the New York Times.Two weeks after PHAC confirmed the presence of SV40, which had been made public through the work of US scientists Dr. Kevin McKernan and Dr. Phillip J. Buckhaults in April 2023, the agency’s Dean Smith, a senior scientific evaluator in the Vaccine Quality Division, wrote an August 23 2023 email to an FDA colleague regarding certain “questions coming to agencies.”“I understand that there have been internal discussions at CBER (Center for Biologics Evaluation and Research) regarding the (presence) of an SV40 enhancer/promoter sequence, noting that its presence is unrelated to the purpose of the Pfizer’s plasmid as a transcription template for their mRNA COVID-19 vaccine,” wrote Smith. “Pfizer has communicated to us recently, that they apparently chose not to mention this information to EMA, FDA or HC at the time of their initial or subsequent submissions.”.The agency was willing to confirm the presence of SV40 only after McKernan and Buckhaults, who warned the plasmid DNA could affect the human genome, raised the issue publicly. McKernan, whose field of expertise is genomics, discovered the quantity of DNA (SV40) in the mRNA shots was higher than the threshold set by regulatory agencies. Health Canada in October confirmed with the Epoch Times the DNA plasmid, which is allegedly used to amplify the mRNA technology, is found in the vaccines. The agency, however, claimed it doesn’t mean the vaccines aren’t safe, because the body breaks it down. Now that it's been made known publicly (through McKernan and Buckhaults), it is “possible for Health Canada to confirm the presence of the enhancer based on the plasmid DNA sequence submitted by Pfizer against the published SV40 enhancer sequence,” wrote PHAC.“Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid (such as an SV40 enhancer) at the time of submission. Although the full DNA sequence of the Pfizer plasmid was provided at the time of initial filing, the sponsor did not specifically identify the SV40 sequence."“The residual plasmid DNA is present in the final product as DNA fragments, due to the enzyme digestion step in the downstream process,” the email response from Health Canada added. “As such, the original risk benefit analysis that supported the initial approval of the Pfizer vaccine continues to be valid.” “Health Canada does not rely on the conclusions provided by vaccine manufacturers. Health Canada conducts an in-depth independent review of the required evidence provided by the manufacturer to ensure that our high standards for safety, efficacy and quality are met.”.In 2007, the FDA published “guidance on regulatory limits for DNA vaccines”, according to the Florida Health website, outlining “important considerations for vaccines that use novel methods of delivery regarding DNA integration.” “DNA integration may result in chromosomal instability” and “affect unintended parts of the body including blood, heart, brain, liver, kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, and the site of administration and subcutis at injection site," the FDA found. “The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk of DNA integration into human cells." In 2022 Pfizer grossed US$37.8 billion for the mRNA COVID-19 vaccines, per data published in 2023 by CNBC, an increase of 3% from 2021. In October 2023, the US Securities and Exchange Commission noted the pharmaceutical giant's projected revenues for 2023 had been revised due to COVID-related sales tapering off.