Colin Carrie on Questions Passed as Orders for Returns

With regard to Health Canada's (HC) approval of the Pfizer COVID-19 mRNA vaccine (BNT162b2): (a) was HC aware that the World Health Organization's internationally accepted guidelines for vaccine evaluation, published in 2005 and 2014, are only applicable to traditional vaccines that contain immunogenic substances and adjuvants, and, if not, why not; (b) if the answer to (a) is affirmative, why did HC not require the use of a guidance document applicable to non-traditional COVID-19 mRNA vaccines that are based instead on gene therapy, such as BNT162b2; (c) did the non-clinical pharmacokinetic studies, which also evaluated the biodistribution of the BNT162b2 (V9) lipid nano-particle (LNP) formulation, reported by Pfizer, show extensive off-target biodistribution to major organs in rodents; (d) if the answer to (c) is affirmative, did HC consider the non-clinical biodistribution data to be a major safety concern, and, if not, why not; (e) were clinical pharmacokinetic studies on the biodistribution of the vaccine-encoded spike protein included in the regulatory submission, and, if not, why not; (f) were clinical studies on appropriate biomarkers (e.g. troponin-1 as an indicator for heart damage, C-reactive protein for inflammation) associated with possible vaccine adverse effects related to spike protein in the blood circulation, included in the regulatory submission, and, if not, why not; (g) were clinical studies on the variability of vaccine-generated spike protein concentration between different vaccine recipients for different lots of the COVID-19 mRNA vaccines administered included in the regulatory submission, and, if not, why not; (h) did HC request that relevant genotoxicity and carcinogenicity studies on the vaccine-generated spike protein, as the active component, be included in the regulatory submission, and, if not, why not; (i) why did HC find as acceptable non-clinical studies of vaccine safety using Wistar Han rats; (j) why did HC find as acceptable toxicology studies on the vaccine-generated spike protein that did not also use a non-rodent species; (k) why did HC find as acceptable toxicology studies that did not use a relevant rodent species, such as the Chinese golden hamster, to examine toxic effects of the vaccine-generated spike protein; (l) why did HC not request toxicology studies using Chinese golden hamsters to examine the distribution of vaccine-generated spike protein in the specific tissues of both the mother and the pups to gather information as to whether BNT162b2 is suitable to administer to pregnant women and mothers who are breastfeeding, for more trustworthy clinical data; (m) was HC aware that Table 1 in the Module 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports, submitted by Pfizer, states that there were 1,223 deaths over a 3-month period, from December 1, 2020 to February 28, 2021; (n) if the answer to (m) is affirmative, why did HC not recommend that COVID-19 mRNA vaccines be immediately taken off the market on the basis of the high mortality rate following drug administration; (o) has HC investigated the flaws in the documentation of Pfizer's regulated study, as shown in Table 1 of the aforementioned report, which classified the case outcomes of 9,400 people as "unknown," and which indicated that the age of 6,876 cases could not be determined, and, if not, why not; (p) how does HC justify its position that there is no special COVID-19 vaccine hazard for humans based on conventional studies of repeat dose toxicity, when not even immune-histochemistry staining for the vaccine-encoded spike protein was performed with any relevant species; and (q) how does HC view the real-world effectiveness of the COVID-19 mRNA vaccines in reducing viral transmission, when considering peer-reviewed studies that document similar peak loads of viable SARS-CoV-2 virus in the upper airway of fully vaccinated infected individuals and unvaccinated infected individuals, as well as reports of vaccine-induced immune suppression, indicated by reduced production of viral N-protein antibodies following breakthrough infection?