Colin Carrie on Questions on the Order Paper

With regard to Health Canada (HC) and the initial Pfizer-BioNTech mRNA product and approval process thereof: (a) did HC ask Pfizer to conduct genotoxicity studies to rule out insertional mutagenesis with DNA contamination; (b) if the answer to (a) is negative, why not; (c) what are the dangers with respect to insertional mutagenesis; (d) in the context of the mRNA vaccine, what is the purpose of the lipid nanoparticle (LNP) delivery system; (e) in the context of the mRNA vaccine manufacturing process, (i) what is the purpose of the SV40 enhancer-promoter-ori sequence, (ii) does it include a 72 base pair Nuclear Targeting Sequences (NTS), (iii) if the answer to (ii) is affirmative, what is the purpose of an NTS; (f) with regard to the plasmid map used in the production of the modified mRNA, (i) on what date did the manufacturer provide the map to HC, (ii) what gene annotation was provided; (g) in relation to (f), did the map contain an SV40 promoter-enhancer sequence and a reverse open reading frame; (h) if no plasmid map was received, why did HC not ask for one; (i) according to the response to Order Paper question Q-2266, “There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine,” as part of the residual DNA testing and measurement, (i) what quantity of DNA fragments and SV40 enhancer-promoter fragments per dose were found in the Pfizer product, (ii) who provided the data to HC, (iii) when was this data provided to HC, (iv) is HC aware that the EMA reported a very large variance with respect to the residual DNA levels in the bulk mRNA and that the SV40 enhancer in the promotor sequence is 72 base pairs, (v) if the answers to (i) and (iv) are affirmative, what was HC’s appraisal of this information, (vi) what analytical techniques did the manufacturer rely upon to quantify the amount of RNA and the amount of DNA, (vii) do these quantities meet the “strict limits and controls for the presence of these residual fragments” and what are those limits; (j) as part of HC’s requirements for lot release testing, has HC independently confirmed the quantity of residual DNA and SV40 sequences in the Pfizer-BioNTech product; (k) if the answer to (j) is affirmative, (i) which laboratory and chief scientist provided this independent testing, (ii) what were the amounts recorded, (iii) were these different than those amounts provided by the manufacturer; (l) if the answer to (j) is negative, why was independent testing not completed; (m) is HC aware that Pfizer deliberately removed the SV40 enhancer sequence when reporting the annotated plasmid; and (n) according to HC's response to Order Paper question Q-2266, “The SV40 promoter enhancer sequence… is inactive, has no functional role, and was measured to be consistently below the limit," (i) who provided HC with this assessment, (ii) is there evidence that the SV40 promoter binds to the P53 tumor suppressor gene and affects DNA repair mechanisms, (iii) if the answer to (ii) is affirmative, what are the risks to the health of Canadians as a result?