Colin Carrie on Questions Passed as Orders for Returns

With regard to Health Canada’s (HC) assessment of risks versus benefits for the COVID-19 vaccines: (a) did HC perform a formal analysis showing that the benefits of the COVID-19 vaccines outweigh the risks (i) at the time of interim order approval, (ii) at the time of authorization, under the amended Food and Drugs Regulation for September 2021, (iii) before the approval of each subsequent booster; (b) if the answer to (a) is affirmative, who performed the analysis and what were the results of the analysis, specifying the benefits and risks (i) at the time of interim order approval, (ii) at the time of authorization, under the amended Food and Drugs Regulation for September 2021, (iii) before the approval of each subsequent booster; (c) what specific scientific studies, real world data, and Canadian morbidity and mortality data were reviewed by HC to conclude the risks of the COVID-19 vaccines outweighed the risk of COVID-19 illness (i) at the time of interim order approval, (ii) at the time of authorization, under the amended Food and Drugs Regulation for September 2021, (iii) before the approval of each subsequent booster; (d) what were the risks that HC determined for the COVID-19 vaccines compared to the risks of the COVID-19 illness (i) stratified across age groups, (ii) for the immunocompromised, (iii) for seniors with two or more comorbidities, (iv) for pregnant and lactating women, and what were these results; (e) did HC use the Cleveland study entitled “Effectiveness of the Coronavirus Disease 2019 Bivalent Vaccine” by N. Shrestha et al to update their risk-benefit analysis of the current COVID-19 vaccine; (f) if the answer to (e) is negative, why not; (g) how were those individuals who received a COVID-19 vaccine classified as being “vaccinated” versus “unvaccinated” for the purposes of statistical analysis of clinical outcomes and vaccine efficacy by the following categories (i) less than two weeks after first dose of the primary series, (ii) between two weeks and three months after first dose of the primary series, (iii) less than two weeks after second dose of the primary series, (iv) more than two weeks after second dose of the primary series, (v) less than two weeks after any booster dose, (vi) more than six months after any booster dose; (h) would the response in (g) be influenced by brand of COVID-19 vaccine, and, if so, how; (i) for Canadian morbidity and mortality data presented to the Canadian public to illustrate the efficacy of the COVID-19 vaccines, how were the definitions from (g) and (h) used; and (j) what data supported the definitions of the vaccination status as defined in (g)?