Dean Allison on Questions on the Order Paper

With respect to Health Canada's (HC) review into the presence of SV40 and other DNA elements in the Pfizer COVID-19 vaccine: (a) in July 2023, what was the basis for an Issue Analysis Summary (IAS) for the SV40 promoter agreed to by Drs Co Pham, Tong Wu and Michael Wall; (b) in July 2023, what was the rationale for HC to submit #1 Clarifax request to Pfizer and (i) what was the outcome of this request, (ii) did the response from the sponsor to #1 Quality Clarifax address all of HC's questions and concerns, and, if negative, what was missing, (iii) did Pfizer provide a complete justification for the SV40 sequences, (iv) did Pfizer provide an updated fully annotated table of functional elements of the plasmid, (v) did Pfizer include non-functional elements of the plasmid in the annotated table specifically addressing any unexpected open reading frames and other sequence elements, (vi) if the answer to (iii), (iv) and (v) is affirmative, what were the results, (vii) if the answer to (iii), (iv) and (v) is negative, what was HC's response; (c) with respect to the quantitative assay used to measure the residual DNA in order to confirm the presence of the SV40 promoter-enhancer, did HC confirm with Pfizer (i) the amplicon size used, (ii) the appropriateness of the primers used; (d) if the answer to (c) is affirmative, what was Pfizer's response; (e) if the answer to (c) is negative, has HC independently verified the total amounts of residual DNA, the appropriateness of the primers, and the amplicon size used by Pfizer to measure the residual DNA in the XBB.1.5 vials; (f) with respect to Pfizer's response in #1, #2 and #3 Quality Clarifaxes, did Pfizer provide the requested information on the fragment size analysis by December 1, 2023; (g) if the answer to (f) is affirmative, what were the results; (h) if the answer to (f) is negative, what was HC's response; (i) concerning the residual plasmid DNA in the drug substance, (i) did Pfizer provide the requested information on the characterization of residual circular DNA plasmid by December 1, 2023, (ii) did Pfizer provide the requested information on the risk of replication in bacterial cells by December 1, 2023, (iii) did HC at any time request information on the risk of replication in mammalian cells; (j) if the answer to (i)(i), (i)(ii) and (i)(iii) is affirmative, what were the results; (k) if the answer to (i)(i), (i)(ii), and (i)(iii) is negative, what was HC's response; (I) did HC request that Pfizer repeat the analyses for fragment size distribution and residual DNA for any of Pfizer COVID-19 vaccines (i.e., original or bivalent); (m) if the answer to (l) is affirmative, what were the findings; (n) if the answer to (l) is negative, why not; (o) did HC independently verify the quantity of residual DNA, the size distribution and the presence of SV40 sequences in the XBB.1.5. vaccine, or any other COVID-19 vaccine submitted by Pfizer for review; (p) at any time, did Pfizer ever suggest that the regulatory sequence elements in question were functional with respect to the manufacturing process, and, if so, what was the function; (q) at any time, did Plizer ever suggest that regulatory sequence elements in question were functional following inoculation into humans; and (r) if the answer to (p) is affirmative, what and when did Pfizer inform HC?