PDF file: 441-2162_DART_studies_International_Council_for_Harmonisation_of_Technical_Reqts_phil.pdf
OPQ ID: 441-2162
Session: 441
Question number: Q-2162
Sessional paper: Q-2162
Title: DART studies & International Council for Harmonisation of Technical Req'ts, phil
Short description: 
Topic: vaccines
Identified concern: 
Keywords: 
Agencies: HC, PHAC, NACI
Date asked: 2023-12-13
Date tabled: 
Submitted by: Mrs. Wagantall (Yorkton—Melville)
Reply by: Minister of Health
Responded by: the Honourable Mark Holland
Pages: 4
Status: not processed
Alert: yellow
Questions asked: 7
Questions answered: 4
Percent responded: 57%
Referenced sources: Canada.ca
Referenced links: https://covidvaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf•, https://covidvaccine.canada.ca/info/SBD00510-comirnaty-en.html•, https://covid-vaccine.canada.ca/info/pdf/covid-19vaccine-moderna-pm-en.pdfX, https://covidvaccine.canada.ca/info/SBD00511-spikevax-en.htmlIt
Official link: https://www.google.com/search?q=Q-2162+ourcommons.ca
PDF URL: https://ivim.ca/foi/opq/r/441-2162_DART_studies_International_Council_for_Harmonisation_of_Technical_Reqts_phil.pdf
TXT URL: https://ivim.ca/foi/opq/r/441-2162.txt
Original filename: Q-2162_HC, DART studies & International Council for Harmonisation of Technical Req'ts, phil.pdf
Local source path: C:\Users\Dmitry\Documents\CODES\OPQ-App\data-raw\OPQ\ALL OPQ TO DATE\2022\Q-2162_HC, DART studies & International Council for Harmonisation of Technical Req'ts, phil.pdf
Machine extracted at: 2026-06-30 12:58:25

References / links:
- https://covidvaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf•
- https://covidvaccine.canada.ca/info/SBD00510-comirnaty-en.html•
- https://covid-vaccine.canada.ca/info/pdf/covid-19vaccine-moderna-pm-en.pdfX
- https://covidvaccine.canada.ca/info/SBD00511-spikevax-en.htmlIt
- Canada.ca

Machine notes:
(none)

Question text preview:
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?