Colin Carrie on Questions on the Order Paper

With regard to Health Canada’s (HC) approval of the Pfizer/BioNTech COVID-19 vaccines: (a) did Pfizer disclose that Process 1 vaccine formula was used during the original trial to obtain their safety and efficacy data while Process 2 was invoked following the Interim Order to massively upscale production of vaccine doses whereby DNA was cloned into a bacterial plasmid vector for amplification in Escherichia coli (E. coli) before linearization with the possibility of potential residual DNA; (b) was HC aware of the quantum of linearized DNA fragments present in each dose of the Pfizer vaccine prior to releasing the vaccine to Canadians, and, if so, what was the amount of acceptable residual DNA per vaccine dose and the method used to measure it; (c) if the response to (b) is negative, has HC since confirmed the quantum of linearized DNA per vaccine dose per mRNA manufacturer, and, if so, what method was used; (d) do the risks of residual DNA meet HC’s standards for transfected foreign DNA; (e) did Pfizer and BioNTech disclose to HC the presence of the Simian Virus 40 (SV40) promoter-enhancer-ori used to amplify the production of Spike mRNA in the DNA plasmid used to produce the mRNA; (f) has HC confirmed the presence of SV40 sequences in the Pfizer vaccine, and, if so, is the amount of SV40 within safe limits and how was it tested; (g) if the response to (f) is negative, when and who will conduct the study to confirm the presence of SV40 and by what method; (h) how were contaminants and impurities addressed throughout the regulatory process for both Pfizer/BioNTech and Moderna products; (i) are further studies planned to investigate how these contaminants and impurities will impact human subjects given transfection for both products, and, if so, who will conduct the investigation and when will it be conducted; (j) is HC considering regulating these products as gene therapy products; and (k) how does HC plan to inform those Canadians who received the mRNA products about the adulteration of these products, specifically SV40 in Pfizer and heightened levels of DNA plasmids in both Pfizer and Moderna products, to ensure fully informed consent?