Dean Allison on Questions on the Order Paper

With regard to Health Canada's (HC) review into the presence of SV40 and other DNA elements in the Pfizer COVID-19 vaccine: (a) what were HC’s concerns regarding "SV40 enhancer-promoter sequence and other non-essential sequences in Pfizer's plasmid for their COVID-19 vaccines" as noted in email correspondences between HC, European Medicines Agency (EMA) and the Food and Drug Administration officials in August 2023 prior to an ad-hoc Cluster meeting held on August 24, 2023; (b) what did HC ask of Pfizer to mitigate the concerns in (a), and what was Pfizer's response; (c) did HC's experts review Kevin McKernan's et al. study entitled “Sequencing of bivalent Moderna and Pfizer mRNA Vaccines reveals Nanogram to Microgram Quantities of Expression Vector dsDNA per Dose”; (d) if the answer to (c) is affirmative, (i) what were HC's summary conclusions, (ii) how did HC respond to those conclusions; (e) is HC still of the position that "there is no peer-reviewed scientific literature suggesting that the SV40 promoter-enhancer itself or the other non-functional elements pose a risk to human health"; (f) if the answer to (e) is negative, what key peer-reviewed scientific literature did HC consider noteworthy; (g) is HC aware of the ability of the SV40 promoter-enhancer to bind to P53 as demonstrated by Drayman et al.; (h) if the answer to (g) is affirmative, (i) was the risk communicated to Pfizer, (ii) what was Pfizer's response; (i) if the answer to (g) is negative, will HC perform a risk analysis to human health; (j) is HC aware of the ability of the SV40 enhancer to act as a nuclear targeting sequence as demonstrated by Dean DA, Dean BS, Muller S, Smith LC. in their study entitled “Sequence Requirements for Plasmid Nuclear Import”; (k) if the answer to (j) is affirmative, was the risk communicated to Pfizer and a response requested; (I) if the answer to (j) is negative, will HC perform an independent risk analysis to human health; (m) if Pfizer's vaccine did not contain unsafe or unexpected plasmid sequences, such as SV40 promoter-enhancer, then why, on August 29, 2023, did Michael Wall state in an email to Tong Wu, "Health Canada will continue to work with international regulatory partners to achieve harmonisation regarding removal of these sequence elements from the plasmid for future strain changes"; (n) what are the "sequence elements" to which Michael Wall was referring; (o) regarding an email, on October 12, 2023, from an EMA colleague to Dr. Dean Smith at HC, which stated "We are going to discuss the matter of SV40 with Pfizer-BioNtech as well as these alleged high level of DNA in vaccines coming from these external parties. Have you taken any action? What would be your perspective?", (i) what action was taken or will be taken to address the "alleged high level of DNA" referenced in the email, (ii) has any action been taken to date, and, if so, what; (p) has HC informed (i) the Public Health Agency of Canada, (ii) Dr. Howard Njoo, (iii) Dr. Theresa Tam, (iv) Dr. Supriya Sharma, (v) the National Advisory Committee on Immunization, (vi) any or all of the provincial or territorial Chief Medical Officers, of the presence of the SV40 enhancer-promoter and DNA fragments; (q) if the answers to (p)(i) to (p)(vi) are affirmative, what were their individual responses; (r) if the answers to (p)(i) to (p)(vi) are negative, why or why not; (s) what risk assessment did HC perform to determine that SV40 promoter-enhancer is safe in an mRNA vaccine within the unique LNP delivery system; (t) what other Canadian vaccines contain SV40 promoter-enhancer sequence; and (u) what is HC's policy about SV40 promoter-enhancer being in any vaccine product?