Internal Emails Reveal Health Canada Official Deleted Scientist’s Note on High Level of Impurity in mRNA Shots

A high-ranking official at Health Canada eliminated reference to a “high level of impurity” in mRNA COVID-19 vaccines in an assessment intended for Canada’s Chief Medical Advisor, internal documents reveal.

The assessment was supposed to summarize recent discoveries regarding the generation of unintended proteins by mRNA COVID-19 vaccines.

Two senior officials from Health Canada raised concerns about the conclusions presented by the HC scientist responsible for compiling the assessment, including the one with the final approval authority for vaccine authorization.

“I am cautious about the 4th bullet addressing impurities that Dr. [Agnes] Klein included,” wrote HC Senior Advisor Poovadan Anoop in a Dec. 14, 2023, email about the internal HC assessment prepared by Dr. Agnes V. Klein, a senior medical advisor at HC. Anoop’s email was directed to his superior, Sophie Sommerer, director general of the Health Canada Biologic and Radiopharmaceutical Drugs Directorate (BRDD), the unit responsible for vaccine approvals.

The Epoch Times acquired the internal documents through the access to information system.

The assessment highlighted that around 8 percent of the proteins generated by the mRNA vaccines were unintended or “frameshifted” proteins capable of stimulating an immune response. Dr. Klein described this as a “high level of impurity.”

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Mr. Anoop raised a question about whether the impurity levels due to frameshift could prevent the vaccines from meeting quality standards, despite the non-harmful nature of the translated proteins. He later informed his superior that he removed a paragraph from the initial assessment referencing the “high level of impurity.”

The detailed scientific piece on Substack discussed the initial frameshifting discovery documented in the journal Nature on Dec. 6. Researchers observed that the mRNA injections, which instruct cells to produce the SARS-CoV-2 virus’ spike protein to prompt an immune response, also generate other unintended, or frameshifted proteins capable of provoking an immune response.

The scientists estimated that approximately 8 percent of the proteins synthesized by the mRNA vaccines are frameshifted.

Dr. Rose expressed concerns in her Substack article that these “off-target proteins” are being produced in many recipients of the COVID-19 shots and could potentially lead to autoimmunity and other issues. Autoimmunity refers to the immune system attacking the body itself, leading to disease conditions.

‘High Level of Impurity’

In her internal assessment, HC scientist Dr. Klein further elaborated on the frameshifting being around 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 mentioned that impurities and metabolic deviations generally do not exceed 1 to 2 percent. If those levels are higher, it “must be investigated and justified,” she noted.

“The fact that the frameshift does not occur with a DNA vaccine might favor DNA vaccines and, overall maybe, against mRNA vaccines,” she added.

Despite expressing these concerns, Dr. Klein stated in the email transmitting her assessment to the senior officials that there is “nothing to worry about in this regard.”

“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,” wrote Mr. Anoop above a summary in bullet-point form drawn from Dr. Klein’s assessment. The Science article downplays concerns with a title stating “mRNA vaccines may make unintended proteins, but there’s no evidence of harm.” It begins by asserting that COVID-19 vaccines have “saved millions of lives.”

As per his LinkedIn profile, Mr. Anoop holds a master’s in microbiology and biotechnology, specializing in risk management and compliance in government settings.

“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 confirm if Dr. Sean Li, a Health Canada research scientist, had shared thoughts on the conclusion.

Ms. Sommerer also inquired about the existence of “standard lines” at BRDD concerning the consideration of scientific literature articles and whether certain criteria determine their relevance for regulatory purposes. She emphasized, “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 term “company” refers to vaccine manufacturers.

Following the receipt of Ms. Sommerer’s email expressing dissatisfaction with Dr. Klein’s conclusion, Mr. Anoop communicated with another senior Health Canada official, stating that he “dumbed down” Dr. Klein’s input and highlighted Ms. Sommerer’s indications of discontent.

Mr. Anoop subsequently emailed Dr. Michael Rosu-Myles, the director of 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 that the concerns regarding frameshifting fall beyond the scope of literature considered by Health Canada in its regulatory capacity.

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

‘Less Optimal’

Dr. Li, who also serves as an adjunct professor at the Department of Biochemistry, Microbiology, and Immunology at the University of Ottawa, conveyed to his colleagues that the issue “may not be a big concern at this point,” highlighting the extensive testing of mRNA vaccines in pre-clinical and clinical studies pertaining to safety and toxicity. He also noted that frameshifting is a common occurrence in normal cells.

However, Dr. Li did not completely dismiss concerns. “These unwanted proteins, while 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 stated.

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

Dr. Li also addressed the 8 percent frameshifting figure, suggesting that if independently verified, it would likely be considered “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 forwarded to Director General Sommerer what appears to be a final assessment on frameshifting, incorporating feedback 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,” noted Mr. Anoop.

The paragraph that was struck out is the one derived from Dr. Klein’s assessment referencing the “high level of impurity.”

Notably, the summary provided by Mr. Anoop no longer contains the concerns raised by Dr. Li regarding mRNA compliance issues and the “relatively high level of frameshift.”

The summary concludes by stating that manufacturers of vaccines are tasked with monitoring the safety of their products and reporting any safety signals to HC. It affirms that the department has “adequate processes in place to evaluate product risk before authorization” and to “continue addressing safety issues that may arise post-authorization.”

The final assessment sent to Chief Medical Advisor Sharma was not included in the records obtained through access to information. The Epoch Times requested its availability from Health Canada and also inquired whether Pfizer-BioNTech and Moderna were approached to discuss the frameshifting concern. A response was not received by the time of publication.

Pfizer-BioNTech and Moderna have not been responding to inquiries from The Epoch Times. Science Magazine stated that when contacted, Pfizer did not specifically address frameshifting concerns but emphasized that its vaccines have a “positive benefit-risk profile.”

Autoimmunity

Responding via email, Dr. Jessica Rose, the author of the scientific Substack article of interest to the Chief Medical Officer, provided her analysis of the internal HC records on frameshifting. Regarding Dr. Li’s statement that there is “no evidence” suggesting that antibodies resulting from frameshifting are harmful, she explained this indicates a lack of understanding of antibody function.

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

Dr. David Wiseman, the lead author of the Nature article, expressed concerns about the actions taken by Health Canada regarding the issue. “What steps is HC taking to identify and characterize the frameshift proteins and assess their toxicity?” he inquired in an email to The Epoch Times.

Meanwhile, Dr. Philip Oldfield, with over thirty years of experience focusing on bioanalysis of protein/nucleic acid therapeutics and regulatory matters, shared with The Epoch Times in an interview that he “wholeheartedly agrees” with HC scientist Dr. Klein’s assessment that 8 percent frameshifting represents a high level of impurity. However, he countered by stating that the remaining 92 percent, which is the SARS-CoV-2 spike protein, “causes most of the damage.”