Questions and responses 45th Parliament, 1st session May 26, 2025, to present

With regard to Health Canada, the Public Health Agency of Canada and the National Advisory Committee on Immunization and their statement, “the benefits of the COVID-19 vaccines outweigh the risks”: (a) what are the benefits of the COVID-19 vaccines, broken down by (i) benefit, (ii) supporting studies or documents and their published date, (iii) start and end dates of the benefit analysis, (iv) name and title of those who analyzed the benefit; (b) what are the risks of the COVID-19 vaccines, broken down by (i) risk, (ii) supporting studies or documents and their published dates, (iii) date on which the risk was identified, (iv) start and end dates of the risk analysis, (v) name and title of those who analyzed the risk; (c) was a risk and benefit analysis performed for each COVID-19 vaccine product; (d) if the answer to (c) is affirmative, (i) what are the start and end dates of each analysis, (ii) what are the differences between the product analysis results; (e) was a separate risk and benefit analysis performed for (i) various age groups, (ii) genders, (iii) pregnant women, (iv) the immunocompromised, (v) First Nations and Indigenous populations; (f) if the answer to (e) is affirmative, for each group in (e), what are the (i) start and end dates for each analysis performed, (ii) name and title of those who performed them; (g) was a risk and benefit analysis performed for Canadians who were previously infected with COVID-19; and (h) if the answer to (g) is affirmative, for each analysis performed, what (i) was the start date, (ii) was the end date, (iii) were the conclusions of the analysis?

With regard to Health Canada’s review of the manufacturing data, quality control and safety of lipid nanoparticles in the mRNA COVID-19 vaccines, including all versions of Moderna’s SpikeVax, Pfizer-BioNTech’s Comirnaty and the boosters, and Onpattro (Patisaran): (a) was the purity of the starting materials for the lipids, such as residual halogenated solvents and elements, including metals, assessed for mutagenic risk in accordance with established norms and guidelines, and, if so, what were the results, and, if not, why not; (b) was the total amount of observed impurities assessed for mutagenic risk, and, if so, what were the results, and, if not, why not; (c) were any individual element impurities considered mutagenic; (d) if the answer to (c) is affirmative, was this assessed with respect to multiple doses and with respect to the nature of transfection of the lipid nanoparticles; (e) was any assessment of the lipid nanoparticle as a nanoparticle performed; (f) if the answer to (e) is affirmative, did this include an assessment of the polyethylene glycol moiety; (g) was an assessment of the risk of complement activation-related pseudoallergy due to the polyethylene glycol moiety performed, and, if so, what were the results, and, if not, why not; and (h) were any complement-related assays requested from the manufacturer, and, if not, why not?

With regard to the recommendations in Health Canada’s publication through the National Advisory Committee on Immunization titled, “Vaccination and pregnancy: COVID-19”: (a) how do these recommendations differ from the May 27, 2025, announcement by the United States of America’s Health and Human Services, stating the COVID-19 vaccine would no longer be included in the Centers for Disease Control and Prevention’s recommended immunization schedule for healthy pregnant women and healthy children (herein referred to as “cohort”) citing “mixed data” on booster safety and efficacy for pregnant women while seeking stricter clinical trials for vaccine approvals in healthy individuals under 65; (b) did communications occur, related to the Health and Human Services announcement, between Health Canada, the National Advisory Committee on Immunization or the Public Health Agency of Canada and (i) Health and Human Services, (ii) the United States of America’s Food and Drug Administration, (iii) the United States’Centers for Disease Control and Prevention, (iv) the United Kingdom’s Medicines & Healthcare products Regulatory Agency, (v) the European Medical Agency; (c) if the answer to (b) is affirmative, what (i) were the dates of the communications, (ii) were the modes of communications, (iii) were the names and titles of people included in the communications, (iv) was the outcome; (d) to Health Canada's knowledge, did the Medicines & Healthcare products Regulatory Agency or the European Medical Agency agree with Health Canada’s recommendations for the administration of the COVID-19 vaccine to this cohort; (e) does Health Canada, the National Advisory Committee on Immunization or the Public Health Agency of Canada have mixed data regarding booster safety and efficacy of the COVID-19 vaccine in this cohort, and, if so, how does this impact the risk-benefit analysis; (f) is Health Canada , the Public Health Agency of Canada or the National Advisory Committee on Immunization including the same or different data than the United States of America’s Health and Human Services, Food and Drug Administration, and Centers for Disease Control and Prevention in the decision to continue recommending the COVID-19 vaccines for this cohort; (g) what clinical trials or data is Health Canada, the National Advisory Committee on Immunization and the Public Health Agency of Canada including in their decision that gives them confidence to continue recommending these vaccines that differs from the United States of America’s Health and Human Services, the Food and Drug Administration, and the Centers for Disease Control and Prevention; (h) is Health Canada planning to request stricter clinical trials for vaccine approvals in healthy individuals under 65 in the future, and, if not, why not; (i) if the answer to (h) is affirmative, what additional vaccine clinical trial requirements will be needed for approval; (j) are there plans to change the recommendations with respect to the COVID-19 vaccine in this cohort; and (k) if the answer to (j) is affirmative, when will these recommendations be announced, and what will they include?

With regard to COVID-19 mRNA vaccine safety and efficacy: (a) has Health Canada reviewed the peer-reviewed, published scientific article by Hulscher N, Alexander P E., Amerling R, Gessling H, Hodkinson R, Makis W et al. titled “A Systematic Review Of Autopsy Findings In Deaths After COVID-19 Vaccination”, Science, Public Health Policy and the Law. 2024 Nov 17; v5.2019-2024; (b) what is Health Canada’s assessment of the study referred to in (a); (c) which department or agency makes the final determination about causality when a family member makes a vaccine injury death claim through the Vaccine Injury Support Program; (d) how many death claims relating to the COVID-19 vaccines have been made to the Vaccine Injury Support Program to date; (e) how many death claims relating to the COVID-19 vaccines have been accepted as being causally related; (f) how many death claims relating to the COVID-19 vaccines have been paid through the Vaccine Injury Support Program and what is that total amount paid out; (g) is an autopsy required in the case of a vaccine injury death claim; (h) if the answer to (f) is affirmative, what specialized immunohistochemistry is required to prove causation in the event of an mRNA vaccine injury death; (i) has Health Canada considered mandating autopsies with appropriate immunohistochemistry staining for sudden deaths; and (j) for the years 2019 to 2024, what is the excess all-cause mortality, broken down by year and reason for mortality?