Canadian Library FOI Record.

CDN LBRY REF #:   110-HC-2023-Q-2163    

CATEGORY:   OPQ   

STATUS:   Agency Completed Request

PROVINCE:   All 

AGENCY:   Federal Govt
AGENCY NAME:   Canada – Minister Of Health

AGENCY FOI NUMBER:  HC-2023-Q-2163

FOI SEARCH DATES.

FROM:  January 1, 2024  

TO:        January 1, 2024
RELATED WEBSITES:   

INTENT OF FOI REQUEST:   

Summary: To find out what data / approvals ensured the Covid-19 vaccines were determined to be safe for Pregnant and Lactating women. Were they adequate? Many questions about clinical trials, placebo, informed consent, patient reporting, etc.
KEY SENTENCE: Health Canada has not approved any safety claims with regard to pregnant and lactating women.
This response is “The Official Statement from the Minister of Health” – this is important because he would have had to sign off on seeing this information to know that there is nothing to say that these are safe for pregnant and lactating women. This is important for people to know.

CONCLUSIONS DRAWN:   

There is little to no confirmations from the manufacturers nor Health Canada.
Key details provided:
(b) None of the COVID-19 vaccine manufacturers sought indications for use in pregnant or lactating women or submitted RCTs in pregnant/lactating women for regulatory evaluation. The Product Monographs included statements about the uncertainties related to pregnancy and lactation.
(c) As indicated above, there were no RCTs in pregnant/lactating women submitted for regulatory evaluation as the vaccine sponsors did not seek an indication for use in pregnant and lactating women.
(d) As indicated in the specific Product Monographs, it is noted that the safety and efficacy of these vaccines in pregnant women have not yet been established. No indication for use in pregnant or lactating women was sought by the vaccine sponsors or authorized by Health Canada.
(e) As noted in the Product Monograph, the safety and efficacy of Comirnaty in pregnant women have not yet been established.
(h) Health Canada has not approved any safety claims with regard to pregnant and lactating women.