Colin Carrie on Questions on the Order Paper

With regard to Health Canada’s standards for safety and efficacy for the COVID-19 vaccines: (a) have any COVID-19 vaccines met the requirements of Section C.08.001(2) of the Food and Drug Regulations (2)(g) and (2)(h) for safety and efficacy; (b) has any COVID-19 designated drug or vaccine, approved under Section C.08.001(2.1) of the Food and Drug Regulations, subsequently met the standard for safety and efficacy as delineated in subsection (2)(g) and (2)(h) of Section C.08.001(2); (c) if the answer to (b) is negative, why not; (d) if a COVID-19 designated vaccine has not met (2)(g) and (2)(h) of C.08.001(2), which requires the sponsor to establish safety and efficacy, can the use of the terms “safe and effective” be applied to these vaccines; (e) if the answer to (d) is affirmative, what is the rationale; (f) with regard to the portal on the approval of COVID-19 vaccines for Comirnaty and available information for COMIRNATY - Submission control number 252736 on the Government of Canada's website, is the information for 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods available to the public under the transparency initiatives; (g) if the answer to (f) is negative, why not; (h) as the mRNA vaccines represent a new manufacturing platform, do they meet the requirements of Section C.04.015 of the Food and Drug Regulations; (i) if the answer to (h) is negative, why not; (j) have the Pfizer-BioNTech and Moderna vaccines been assigned to Group 2 Lot Evaluation Group as part of the Lot Release Program; and (k) if the answer to (j) is negative, why not?