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 prompted by a scientific paper on Substack that analyzed recent findings in another article published in the journal Nature that said mRNA vaccines may prompt cells to produce unintended proteins.
Two senior Health Canada (HC) officials, including the one with final authority on vaccine authorization, expressed concerns about one of the points noted by the HC scientist tasked with producing the assessment.
“I am very wary of the 4th bullet on impurities that Dr. [Agnes] Klein had put in,” HC senior adviser 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 and Dr. Klein’s 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 an access-to-information request.
The assessment had noted the findings in the Nature article, published Dec. 6, that about 8 percent of the proteins produced by the mRNA shots were unintended, or “frameshifted,” proteins capable of evoking “off-target cellular immune responses.” Dr. Klein called it a “high level of impurity.”
In his Dec. 14 email to his superior, Mr. Anoop asked: “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.” In a subsequent email to her, he would tell her that he “struck out a bullet” from the assessment mentioning the “high level of impurity.”
The Nature article 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 a decent percentage of 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 its own healthy cells and tissues, which can lead to disease.
‘High Level of Impurity’
In her internal assessment, HC scientist Dr. Klein expanded on her thoughts on 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 said impurities and metabolic deviations usually do not exceed 1 or 2 percent, and levels that are higher “must be investigated and justified.”
“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 those concerns, Dr. Klein said in her Dec. 13 email accompanying her assessment document that there is “nothing to worry about in this regard.”
‘Made Changes’
It was after Dr. Klein provided her input on frameshifting that Mr. Anoop sent his Dec. 14 email expressing concerns to his superior Ms. Sommerer.“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 his bullet-point summary drawn from Dr. Klein’s assessment.
The Science article plays down concerns. Titled “mRNA vaccines may make unintended proteins, but there’s no evidence of harm,” its opening paragraph says that COVID-19 vaccines “saved millions of lives.”
“I’m a little concerned about the overall conclusions below re. concern about manufacturing and impurities of mRNA vaccines,” she wrote without elaborating. She asked Mr. Anoop to check whether Dr. Sean Li, an HC research scientist with BRDD, had commented on the conclusion. Dr. Li is with BRDD’s Centre for Oncology, Radiopharmaceuticals and Research.
Ms. Sommerer also asked if the BRDD has “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.
After receiving Ms. Sommerer’s email expressing discontent with Dr. Klein’s conclusion, Mr. Anoop forwarded the email trail to Dr. Michael Rosu-Myles, director of the BRDD centre where Dr. Li resides, stating that he had “dumbed down” Dr. Klein’s input and also flagged Ms. Sommerer’s comments expressing her concern.
Mr. Anoop also told Dr. Rosu-Myles, “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,” suggesting that the frameshifting issues fall outside the literature HC typically considers in its regulatory role.
‘Less Optimal’
Dr. Li, also an adjunct professor at the University of Ottawa Faculty of Medicine’s Department of Biochemistry, Microbiology and Immunology, wrote to his colleagues that the issue “may not be a big concern at this point.” He pointed to mRNA vaccines having gone through “vigorous testing in pre-clinical and clinical studies with respect to safety or toxicity.” He added that frameshifting “happens rather often in the normal cells.”“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 by other groups, 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 Mr. Anoop sent to director general Ms. Sommerer what appears to be a final draft assessment on frameshifting, drawing on the inputs from Dr. Klein, Dr. Li, and Dr. Rosu-Myles, with two bullets more than the original five but with one bullet struck out.“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 bullets produced by Mr. Anoop does not contain the concerns raised by Dr. Li about mRNA conformity issues and the “relatively high level of frameshift.”
One of the two new bullets consisted of wording from Dr. Li’s assessment about how there “may not be a big concern at this point.” The other new bullet summarized comments from Dr. Rosu-Myles’s Dec. 21 email and Ms. Sommerer’s Dec. 20 email about vaccine companies’ responsibilities.
It says vaccine makers are expected to monitor their products and report safety signals to HC and that 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 adviser Dr. Sharma was not included in the records obtained via the access-to-information request. Health Canada has told The Epoch Times after the initial publication of this report that a final assessment was never sent to Dr. Sharma. Asked why that is, the department did not answer.
The Epoch Times also asked Health Canada whether it has contacted Pfizer-BioNTech and Moderna to discuss the frameshifting issue but it did not answer.
Autoimmunity
Reached by email, Dr. Jessica Rose, author of the Substack article that the chief medical adviser 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 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.”
Dr. David Wiseman, lead author of the commentary, 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.”
In a study published last year in the journal 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.”
