EXCLUSIVE: Health Canada Official Deleted Scientist’s Note Saying mRNA Shots Have ‘High Level of Impurity’: Internal Emails

A senior Health Canada official removed mention of a “high level of impurity” in mRNA COVID-19 vaccines in an assessment done by a colleague for the department’s chief medical adviser, internal records show.

The assessment was meant as a brief on recent findings about the creation of unintended proteins by mRNA COVID-19 vaccines.

Two senior Health Canada (HC) officials, including the one with final authority on vaccine authorization, expressed concerns about the conclusions written by the HC scientist tasked with producing the assessment.

The assessment was meant as a brief on recent findings about the creation of unintended proteins by mRNA COVID-19 vaccines.

“I am very wary of the 4th bullet on impurities that Dr. [Agnes] Klein had put in,” HC Senior Advisor Poovadan Anoop wrote in a Dec. 14, 2023, email referring to the internal HC assessment written by Dr. Agnes V. Klein, a senior medical advisor with HC. Mr. Anoop’s email was addressed to his superior, Sophie Sommerer, director general of Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate (BRDD). The unit is responsible for approving vaccines.

The Epoch Times obtained the internal records through the access to information system.

The assessment had noted about 8 percent of the proteins produced by the mRNA shots were unintended or “frameshifted” proteins capable of evoking an immune response. Dr. Klein called it a “high level of impurity.”

“Does this mean with the impurity levels caused by frameshift, the vaccines would not pass muster, notwithstanding the fact that the translated proteins are not harmful,” Mr. Anoop asked in his email. He later told his superior that he “struck out” a paragraph drawn from the original assessment mentioning the “high level of impurity.”

The assessment and exchange began two days earlier, when Chief Medical Advisor Supriya Sharma tasked her staff to produce a “‘quick and dirty’” assessment on a research article by immunologist and public health researcher Dr. Jessica Rose posted on Substack. The chief medical advisor sought a review of the information and the “‘claims’ being made” in Dr. Rose’s analysis.

The lengthy scientific Substack post discussed the initial frameshifting discovery reported in the journal Nature on Dec. 6. Scientists found that the mRNA injections, which give instructions to the cells to create the SARS-CoV-2 virus’ spike protein to generate an immune response, also produce other unintended, or frameshifted proteins that are capable of evoking an immune response.

The researchers estimated that approximately 8 percent of the proteins generated by the mRNA shots are frameshifted.

Dr. Rose wrote in her Substack article that one of her concerns is that those “off-target proteins” are being produced in many people who received the COVID-19 shots and that this “may lead to autoimmunity and/or other problems.” Autoimmunity refers to the human immune system mounting a response against itself which can lead to disease states.

‘High Level of Impurity’

In her internal assessment, HC scientist Dr. Klein expanded further about the frameshifting being at about 8 percent.

“If one were to consider this as an impurity during manufacturing or part of an impurity that can develop during the uptake and metabolism of a drug, which does happen in other instances, one would have to consider this as a high level of impurity,” she wrote.

Dr. Klein added that impurities and metabolic deviations usually do not exceed 1 or 2 percent. In the event those levels are higher, this “must be investigated and justified,” she said.

“The fact that the frameshift does not exist with a DNA vaccine, may speak in favour of DNA vaccines and, overall maybe, against mRNA vaccines,” she added.

Despite raising those concerns, Dr. Klein said in the email containing her assessment to the senior officials that there is “nothing to worry about in this regard.”

An online biography for Dr. Klein says she is trained in medicine and public health and has 40 years of experience in the development and regulation of therapeutics. She also reportedly received “wide recognition and awards for her regulatory work.”

‘Made Changes’

It’s after Dr. Klein provided her input on frameshifting that Mr. Anoop sent his Dec. 14 email expressing concerns to his superior, Ms. Sommerer.

In providing his response, Mr. Anoop referenced a news piece published in Science Magazine on the same day (Dec. 6, 2023) Nature published its ground-breaking article on mRNA frameshifting.

“I read the Science article for my own interest and have made changes in this summary (as opposed to the report provided by Dr. Klein) to make the message clear,” Mr. Anoop wrote above a bullet-point form summary drawn from Dr. Klein’s assessment. The Science article plays down concerns and is titled “mRNA vaccines may make unintended proteins, but there’s no evidence of harm.” It asserts in its opening that COVID-19 vaccines “saved millions of lives.”

According to his LinkedIn profile, Mr. Anoop has a master’s in microbiology and biotechnology, and his government experience is in risk management and compliance.

Ms. Sommerer, the head of BRDD, responded to Mr. Anoop on Dec. 20 and echoed his concerns about Dr. Klein’s assessment. Ms. Sommerer has a master’s in biology and has worked in policy for Health Canada since 2010, according to her LinkedIn profile.

“I’m a little concerned about the overall conclusions below re. concern about manufacturing and impurities of mRNA vaccines,” she wrote without elaborating. She then tasked Mr. Anoop to check whether Dr. Sean Li, a Health Canada research scientist, had commented on the conclusion.

Ms. Sommerer also asked whether the BRDD had “standard lines” on whether or how it considers articles in scientific literature. She then wrote: “We need to remind everyone that the company is expected to monitor the safety of their vaccines and report to HC if they identify any potential signals.” The “company” refers to vaccine manufacturers.

Health Canada has previously told The Epoch Times, on the matter of the undisclosed presence of the Simian Virus 40 enhancer sequence in the mRNA shots, that it does not conduct its own investigations and rather relies on material submitted by pharmaceutical companies. The material is then reviewed by HC.

After receiving Ms. Sommerer’s email expressing discontent with Dr. Klein’s conclusion, Mr. Anoop told another senior Health Canada official that he had “dumbed down” Dr. Klein’s input and also flagged Ms. Sommerer’s comments expressing her dissatisfaction with it.

Mr. Anoop then emailed Dr. Michael Rosu-Myles, the director of the Health Canada’s Centre for Oncology, Radiopharmaceuticals and Research. “I know you also have a line on how we consider literature articles – we need to say that we consider only those articles that are under the scope of review and regulatory requirements,” Mr. Anoop said, suggesting the issues about frameshifting fall outside the literature that Health Canada typically considers in its regulatory role.

Dr. Rosu-Myles replied to Mr. Anoop the next day, on Dec. 21, providing input from Dr. Sean Li, a Health Canada research scientist with a background in virology and immunology.

‘Less Optimal’

Dr. Li, who is also an adjunct professor at the University of Ottawa’s Department of Biochemistry, Microbiology and Immunology, wrote to his colleagues that the issue “may not be a big concern at this point,” pointing to mRNA vaccines having gone through “vigorous testing in pre-clinical and clinical studies with respect to safety and toxicity.” He also added that frameshifting happens rather often in normal cells.

Nevertheless, Dr. Li did not completely dismiss concerns. “These unwanted proteins, while we cannot absolutely [original emphasis] excuse any possible ‘undesirable’ effects to our cell proliferation or toxicity, they are often be cleaned up by degradation [sic],” he said.

“Apparently, the mRNA vaccines had generated a just bit [sic] more than the cells could mop out,” the research scientist said, adding there is “no evidence” suggesting that the antibodies resulting from the frameshift are harmful.

Dr. Li also commented on the 8 percent frameshifting figure, saying that if the figure were independently confirmed, it would “likely be thought as being less optimal.”

“It would need a rather marked conformation change in a regular mRNA to be prone to such relatively high level of frameshift.”

‘Struck Out’

On Dec. 22, Senior Advisor Anoop sent to Director General Sommerer what appears to be a final draft assessment on frameshifting, drawing on the inputs from Dr. Klein, Dr. Li, and Dr. Rosu-Myles.

“I struck out a bullet as that seems to be leaping to a pronouncement when you consider what Michael [Dr. Rosu-Myles] indicates in his/Sean Li’s assessment,” wrote Mr. Anoop.

The struck-out paragraph is the one taken from Dr. Klein’s assessment mentioning the “high level of impurity.”

Notably, the summary produced by Mr. Anoop also does not contain the concerns raised by Dr. Li about mRNA conformity issues and the “relatively high level of frameshift.”

The summary concludes by saying that vaccine makers are expected to monitor their products and report safety signals to HC. It says the department has “sufficient processes in place to evaluate product risk prior to authorization” and to “continue to identify safety issues that may arise post-authorization.”

The final assessment sent to Chief Medical Advisor Sharma was not included in the records obtained via access to information. The Epoch Times asked Health Canada that it be provided and also asked whether Pfizer-BioNTech and Moderna were contacted to discuss the frameshifting issue. A response was not obtained by publication time.

Pfizer-BioNTech and Moderna have not been returning inquiries from The Epoch Times. Science Magazine said Pfizer did not directly comment on frameshifting when contacted, but instead said its vaccines have a “positive benefit-risk profile.”

Autoimmunity

Reached by email, Dr. Jessica Rose, the author of the scientific Substack article the Chief Medical Officer had questions about, provided her analysis of the internal HC records on frameshifting. Regarding Dr. Li’s comment that there is “no evidence” suggesting that the antibodies derived from frameshifting are harmful, she said this indicates there is a lack of understanding of the function of antibodies.

“This is NOT about ‘antibodies being harmful,’” she said. “This is about unforeseen, inappropriate induction of potent immune responses that can lead to autoimmune conditions that can be life-altering at best, and life-threatening at worst.”

Autoimmune diseases linked to COVID-19 vaccination have been reported in recent scientific literature.

In July, scientists wrote in the journal Autoimmunity Reviews there is “growing evidence” suggesting that COVID-19 vaccination “may cause new-onset autoimmune diseases.” The authors, however, mention the causal relationship remains to be demonstrated.

In a commentary pre-print in response to the Nature article, Dr. Rose and other scientists wrote that the findings are “sufficient cause for regulators to conduct full risk assessments of past or future harms that may have ensued.”

Dr. David Wiseman, the lead author of the paper, expressed concerns about what Health Canada is doing about the issue. “What efforts is HC doing to identify and characterize the frameshift proteins and to determine their toxicity?” he said in an email to The Epoch Times.

Meanwhile, Dr. Philip Oldfield, who has over three decades of experience specializing in the bioanalysis of protein/nucleic acid therapeutics and regulatory affairs, told The Epoch Times in an interview that he “totally agrees” with HC scientist Dr. Klein’s assessment that 8 percent frameshifting is a high level of impurity. But he counterpointed that the rest of the 92 percent, which is the SARS-CoV-2 spike protein, “does most of the damage.”

Dr. Oldfield said the amount of spike protein produced by mRNA in the body and the biodistribution is still unknown, a fact recognized by Health Canada. “Now with the frameshifting issue, it’s even more imperative to know what you’re producing and where it goes,” he said.

Health Canada says in information recently tabled in Parliament that “biodistribution data identified no cause of concern as the spike protein is expressed transiently.” Meanwhile peer-reviewed scientific literature shows that the spike protein can end up anywhere in the body and stay there for prolonged periods.

In a study published last year in European Review for Medical and Pharmacological Sciences, Italian scientists noted finding the viral spike protein in the blood serum of patients two months after vaccination.

After looking at the internal HC records on frameshifting, Dr. Oldfied said he noted a “lack of objectivity” and a deliberate attempt to “play it down.”

“They basically tried to find as much information in order to debunk the fact that it might be serious,” he says. “It doesn’t give me confidence that they’re there to make us safe.”