Cheryl Gallant on Questions on the Order Paper

With regard to Health Canada's (HC) signing of the contract with Pfizer on October 26, 2020, and the subsequent release of the Pfizer mRNA COVID-19 vaccine to the Canadian public: (a) was HC aware of a presentation made to the Vaccines and Related Biological Products Advisory Committee on October 22, 2020, where Dr. Steve Anderson at the US Food and Drug Administration's Center for Biologics Evaluation and Research, presented "Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness"; (b) if the answer to (a) is affirmative, did HC review the presentation deck, specifically slide #16, which identified a working list of 22 "possible adverse event outcomes", including acute myocardial infarction, stroke, myocarditis, pericarditis and death; (c) if the answer to (a) is negative, at what point did HC become aware of this presentation material or these serious adverse events of special interest; (d) once HC was in possession of this information, where and when did HC publish this list of 22 "possible adverse event outcomes" for the purpose of informing (i) the general public, (ii) medical physicians and hospitals, (iii) the media; (e) how did HC plan to independently and actively monitor these 22 "possible adverse event outcomes"; (f) did the initial Pfizer monograph posted on HC's website on December 9, 2020, and the ones posted thereafter identify any of these 22 "possible adverse event outcomes"; (g) when Pfizer vaccines were first being administered in early 2021, did HC require the sponsor to include a package insert in each mRNA vaccine vial containing a fully printed monograph of the product's ingredients and side effects including the identified 22 "possible adverse event outcomes" for both the consumer and the health professional to ensure full, informed consent; (h) if the answer to (g) is negative, (i) why was this not required, (ii) how was full, informed consent achieved at the time of vaccination; (i) did HC plan to actively monitor and publish the 1,291 "serious adverse events (SAEs) of special interest" which were contained in the Appendix of Pfizer's report of April 30, 2021, entitled "5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021" to ensure medical awareness of these potential SAEs; (j) if the answer to (i) is affirmative, (i) how were the SAEs monitored, (ii) what information was gathered; and (k) if the answer to (i) is negative, why are the 1,291 SAEs of special interest being monitored by the US Food and Drug Administration and not by HC?