Cathay Wagantall on Questions on the Order Paper

With regard to Health Canada’s use of preclinical manufacturer’s data for authorizing COVID-19 vaccines: (a) did Health Canada (HC), the Public Health Agency of Canada (PHAC) and the National Advisory Committee on Immunization (NACI) follow The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards; (b) were Developmental and Reproductive Toxicity (DART) guidelines required to be met for the determination of safety for either the Pfizer or the Moderna products for pregnant and lactating mothers; (c) if the answer to (b) is affirmative, (i) did the animal studies assess any effects within a complete reproductive cycle from conception to the reproductive capacity of the next generation, (ii) did the animal studies evaluate long term outcomes in offspring, (iii) were any fetal or offspring abnormalities detected, (iv) what fetal or offspring abnormalities were detected, (v) what is the significance of the fetal or offspring abnormalities in defining safety, (vi) were any adverse events observed in the mothers, (vii) what is the significance of adverse events observed in the mothers for human safety, (viii) was decreased fertility detected in the first or second generation, (ix) were biodistribution studies conducted in the pregnant animals and their fetuses, (x) were alternate routes of exposure studied in the animals including through mating with a vaccinated male or transmammary routes; (d) if the answer to (b) is negative, what requirements needed to be met with respect to DART prior to the interim order approval and after the interim approval?