PDF file: 441-2154_pregnancy_and_lactation_part_1_susan_and_deanna.pdf
OPQ ID: 441-2154
Session: 441
Question number: Q-2154
Sessional paper: Q-2154
Title: pregnancy and lactation part 1, susan and deanna
Short description: 
Topic: vaccines
Identified concern: 
Keywords: 
Agencies: HC, PHAC, NACI
Date asked: 2023-12-12
Date tabled: 
Submitted by: Mr. Falk (Provencher)
Reply by: Minister of Health
Responded by: the Honourable Mark Holland
Pages: 4
Status: not processed
Alert: yellow
Questions asked: 8
Questions answered: 6
Percent responded: 75%
Referenced sources: Canada.ca
Referenced links: (none extracted)
Official link: https://www.google.com/search?q=Q-2154+ourcommons.ca
PDF URL: https://ivim.ca/foi/opq/r/441-2154_pregnancy_and_lactation_part_1_susan_and_deanna.pdf
TXT URL: https://ivim.ca/foi/opq/r/441-2154.txt
Original filename: Q-2154_HC, pregnancy and lactation part 1, susan and deanna.pdf
Local source path: C:\Users\Dmitry\Documents\CODES\OPQ-App\data-raw\OPQ\ALL OPQ TO DATE\2022\Q-2154_HC, pregnancy and lactation part 1, susan and deanna.pdf
Machine extracted at: 2026-06-30 12:58:25

References / links:
- Canada.ca

Machine notes:
(none)

Question text preview:
With regard to Health Canada monitoring Pfizer's COVID-19 vaccine: (a) did Health Canada (HC), the Public Health Agency of Canada
(PHAC), the National Advisory Committee on Immunization (NACI) or Canadian Institute for Health Information (CIHI) receive the report entitled Pregnancy and Lactation, Cumulative Review from Pharmacovigilance Database, dated April 20, 2021, or an equivalent document;
(b) if the answer to (a) is affirmative, what are the details, including the (i) date HC, PHAC, NACI or CIHI received a report outlining clinical data any period from the time of drug product development to the end of the first six months of the roll out, (ii) report name, (iii) percentage of pregnant women who reported adverse events, (iv) percentage of lactating women who reported adverse events in themselves and their newborns;
(c) what is HC's analysis of the document in (a) relative to, (i) premature deliveries, (ii) miscarriages, (iii) spontaneous abortions,
(iv) stillbirths, (v) maternal deaths, (vi) the percentage of pregnant women who reported adverse events, (vii) the percentage of lactating women who reported adverse events in themselves or their newborns;
(d) if the answer to (a) is negative does HC, PHAC, NACI or CIHI plan to request this report or equivalent report from Pfizer;
(e) with respect to passive surveillance, what is the established threshold for conditions listed in (c) (i) to (v) for withdrawing approval for this population;
(f) for institutions who met the continuous review of global vaccine safety surveillance rule which showed no evidence of any adverse pregnancy or neonatal outcomes associated with COVID-19 vaccination, what are the (i) institution names, (ii) links, (iii) supporting document names?