PDF file: 441-2163_pregnancy_and_lactation_part_2.pdf
OPQ ID: 441-2163
Session: 441
Question number: Q-2163
Sessional paper: Q-2163
Title: pregnancy and lactation, part 2
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: 10
Questions answered: 8
Percent responded: 80%
Referenced sources: Canada.ca, COVID-19 vaccines and treatments portal
Referenced links: https://covid-vaccine.canada.ca/, https://www.canada.ca/en/publichealth/services/immunization-vaccines/vaccination-pregnancy-covid-19.htmlHealth, https://covidvaccine.canada.ca/info/SBD1700495075939-comirnaty-omicron-xbb-1-5-en.html
Official link: https://www.google.com/search?q=Q-2163+ourcommons.ca
PDF URL: https://ivim.ca/foi/opq/r/441-2163_pregnancy_and_lactation_part_2.pdf
TXT URL: https://ivim.ca/foi/opq/r/441-2163.txt
Original filename: Q-2163_HC pregnancy and lactation, part 2.pdf
Local source path: C:\Users\Dmitry\Documents\CODES\OPQ-App\data-raw\OPQ\ALL OPQ TO DATE\2022\Q-2163_HC pregnancy and lactation, part 2.pdf
Machine extracted at: 2026-06-30 12:58:25

References / links:
- https://covid-vaccine.canada.ca/
- https://www.canada.ca/en/publichealth/services/immunization-vaccines/vaccination-pregnancy-covid-19.htmlHealth
- https://covidvaccine.canada.ca/info/SBD1700495075939-comirnaty-omicron-xbb-1-5-en.html
- Canada.ca
- COVID-19 vaccines and treatments portal

Machine notes:
(none)

Question text preview:
With regard to Health Canada’s COVID-19 vaccine safety monitoring and assessment for pregnant and lactating (P&L) women: (a) are observational trials and surveillance systems adequate to establish safety or must this be accomplished through randomized trials;
(b) were randomized control trials (RCTs) used to obtain approval and support safety claims in P&L women, and, if so, what are the details, including, the (i) name of the trial, (ii) date of the trial;
(c) did the trials in (b) (i) include all trimesters, (ii) include high risk pregnancies, (iii) include clinical and sub-clinical testing, (iv) include a trial group measured against a placebo control group, (v) include a control group which remained intact for multiple years to establish long term safety data, (vi) be sufficiently powered to detect common and rare side-effects;
(d) if the answer to (b) is negative, what trials were used to evaluate the safety in the P&L population prior to approval in this cohort, including the (i) trial name, (ii) trial date, (iii) analysis of the trial;
(e) did Health Canada (HC), the Public Health Agency of Canada, the National
Advisory Committee on Immunization or Canadian Institute for Health Information inform pregnant and lactating women of the Pfizer monograph “No data are available yet regarding the use of COMIRNATY Omicron XBB.1.5 during pregnancy” or “No data are available yet regarding the use of COMIRNATY Omicron XBB.1.5 during breast- feeding.
It is unknown whether COMIRNATY Omicron XBB.1.5 is excreted in human milk.
A risk to the newborns/infants cannot be excluded";
(f) if the answer to (e) is affirmative, how were pregnant and lactating women advised of the Pfizer safety data;
(g) what is HC’s scientific basis for claiming safety of the XBB.1.5 mRNA product in P&L women;
(h) what rigorous prospective studies, with active patient reporting and monitoring, is HC relying upon to support their safety claims in the P&L population for the use of Omicron XBB.1.5 product?