Questions and responses All Sessions January 17, 1994, to present

With regard to expenditures on alcohol, beer and cannabis products by government departments, agencies, the Governor General's office, the Office of the Prime Minister, and Cabinet, since January 1, 2020, and broken down by year, month and entity: (a) what was the total expenditure on alcohol and beer; and (b) what was the total expenditure on cannabis?

With regard to the Canada Health Transfer, since 2016 and broken down by year: (a) did the government impose any conditions in exchange for releasing the payments to any or all provinces or territories; and (b) if the answer to (a) is affirmative, what were the new conditions, broken down by year and by province or territory?

With regard to Canada’s involvement in the United Nations Fund for Population Activities (UNFPA): (a) which departments, agencies or other government entities work with, or have worked with, the UNFPA since 2016, and what is the nature of the work; (b) for each department, agency, or entity in (a), what were their main priorities and goals related to their participation in the UNFPA; (c) what have been the government’s active and inactive UNFPA programs since 2016; (d) what strategic planning is the government involved in, or aware of, regarding public health and 15-minute cities; and (e) what is the government’s understanding of how the UNFPA intersects with the Pan-Canadian Health Organization?

With regard to the Canada Border Services Agency (CBSA), Immigration, Refugees and Citizenship Canada, and the COVID-19 pandemic: (a) how many migrant workers entered Canada between (i) April 1, 2020, and October 31, 2020, (ii) April 1, 2021, and October 31, 2021, (iii) April 1, 2022, and October 31, 2022, broken down by province; (b) what are the details of the quarantine period, including (i) how many migrant workers were quarantined, per province, (ii) when they were quarantined, by month and year, (iii) the length of the quarantine period, (iv) who paid for their quarantine accommodations, (v) the overall cost to the government; (c) how many migrant workers received their COVID-19 vaccine in Canada upon their arrival in Canada between (i) April 1, 2020, and October 31, 2020, (ii) April 1, 2021, and October 31, 2021, (iii) April 1, 2022, and October 31, 2022, broken down by province; (d) in cases where the migrant worker was already COVID-19 vaccinated in his or her country of origin, did Canadian immigration authorities document the date of vaccination and the vaccine brand for migrant workers, and what is the data; (e) in cases where the migrant worker received an unapproved COVID-19 vaccine brand prior to entry, would they require receipt of a Canadian approved brand upon entry; (f) following COVID-19 immunization, how many migrant workers (i) sought medical attention, (ii) were determined too ill to work, (iii) were hospitalized, (iv) died while in Canada; (g) for each case in (f)(i) to (f)(iv), how many occurences were between (i) April 1, 2020, and October 31, 2020, (ii) April 1, 2021, and October 31, 2021, (iii) April 1, 2022, and October 31, 2022, broken down by province; (h) in cases where a migrant worker died following immunization, what were the causes of death; (i) with regard to persons in (h), were any autopsies performed on any deceased migrant workers; (j) if the answer to (i) is affirmative, how many autopsies were performed and what were the findings; (k) how many deceased bodies or their cremated remains were sent back to their country of origin between (i) April 1, 2020, and October 31, 2020, (ii) April 1, 2021, and October 31, 2021, (iii) April 1, 2022, and October 31, 2022; and (l) in cases where a migrant worker had an adverse event following their COVID-19 vaccination in Canada, would they qualify for Canada’s Vaccine Injury Support Program?

With regard to Health Canada’s review of the manufacturing data, quality control and safety of lipid nanoparticles (LNPs): (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 LNPs; (e) was any assessment of the LNP as a nanoparticle performed; (f) if the answer to (e) is affirmative, did this include an assessment of the PEG moiety; (g) was an assessment of the risk of complement activation-related pseudoallergy due to the PEG 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 Health Canada’s (HC) decision to approve the COVID-19 modRNA vaccines and the Prime Minister’s subsequent support for the vaccine mandates in the federal public sector and vaccine passports for travel purposes during the Covid-19 pandemic: (a) what is the immunological mechanism of action of the COVID-19 mRNA vaccines that enables them to stop the spread of SARS-CoV2; (b) what data supports the mechanism of action referred to in (a); (c) who or what agency provided the data and verified the data; (d) when was this data provided to (i) HC, (ii) the Prime Minister’s office; (e) what data did Pfizer and Moderna produce to HC that demonstrated (i) the period of time spike protein is produced in the body, (ii) where in the body the spike protein is produced; and (f) in relation to (e), what was the period of time Pfizer and Moderna tracked spike protein in their clinical studies?

With regard to communication and meetings between the former Attorney General of Canada and the Chief Justice of Canada from January 2020 to June 2022, and the Office of the Prime Minister (PMO) and the Chief Justice of Canada during the same period: (a) how many times did the Attorney General and Chief Justice communicate with each other; (b) how many times did the PMO and Chief Justice communicate with each other; (c) what are the details of each communication in (a) and (b), including, the (i) date, (ii) subject, (iii) names of the people included in the communication, (iv) type of communication (e.g. email, phone, text, memorandum, messaging software, video conference, in person meeting, fax); (d) how many meetings occurred between (i) the Attorney General and the Chief Justice, (ii) the PMO and the Chief Justice; and (e) what are the details for each meeting in (d), including the (i) date, (ii) time, (iii) location, (iv) purpose of the meeting, (v) topics discussed in the meeting, (vi) meeting attendees, (vii) outcome of the meeting?

With regard to Health Canada’s (HC) and the Public Health Agency of Canada’s (PHAC) decision to withdraw the market authorization of and to destroy the COVID-19 XBB.1.5 vaccines and future assessment of upcoming mRNA vaccines: (a) are there material differences between the XBB.1.5 COVID-19 vaccines and the new 2024-2025 formulation beyond the mRNA coding for a different spike protein strain; (b) if (a) is affirmative, what are the differences; (c) if the answer to (a) is affirmative, how will Canadians processing claims against the vaccine manufacturers be able to prove their allegations when physical evidence is required and has been destroyed; (d) what is the estimated number of COVID-19 vaccine vials that will be destroyed, broken down by manufacturer (Pfizer, Moderna, AstraZeneca, others); (e) what is the estimated dollar cost to Canadians to destroy these vaccine products, per vaccine and in total; (f) what is the regulatory process for COVID-19 vaccines which resulted in a “contractual obligation for Health Canada to withdraw all XBB products from the market until a lot could be released and distributed in Canada” (Global news); (g) what is the contractual obligation in (f) and with whom; (h) will provinces be able to order any interim supply of the COVID-19 XBB vaccines and, if not, why not; (i) with respect to the statement made by Pfizer/BioNTech on October 20, 2023, found on page 56 of Access to Information and Privacy (ATIP) 2024-000097-2024-08-22, that Pfizer “would be open to discuss the outcome from the plasmid backbone modification evaluation with Health Canada”, does HC expect the removal of the SV40 sequences from the updated Pfizer/BioNTech COVID-19 vaccines for 2024-25; (j) is HC considering the assessment of future mRNA-based vaccines to continue under the Centre for Vaccines, Clinical Trials and Biostatistics or to be transferred to another Centre or Department within Biologic and Radiopharmaceutical Drugs Directorate or elsewhere, and, if so, what would be the criteria or rationale?

With regard to the government’s response to Order Paper Question Q-2741 relating to Statistics Canada (StatCan) and released data of provisional deaths and excess mortality during the time frames of June 13-27, 2022, July 4-18, 2022, and July 25-August 29, 2022: (a) what are the timeframe-matched denominators (i.e., the total number of individuals by vaccination status by dose and by age group) for each of the following vaccination status categories (i) COVID-19 cases following vaccination, (ii) COVID-19 cases in the unvaccinated, (iii) deaths following vaccination according to doses 1, 2 and 3, (iv) deaths in the unvaccinated; (b) what steps were taken to investigate the underlying reasons for this unusual finding of excess deaths in young persons; (c) why is there a discrepancy between the data that was released on the StatCan website for “other ill-defined and unspecified causes of mortality” in 2022 and the value provided in the government response to Order Paper Question Q-1115 for the same year and same category; and (d) what are the details of the memo drafted by the PCO in May 2021 which instructed recipients to skew statistics to minimize the impact of vaccine-related deaths or injuries, including (i) which agencies or entities and which specific officials received this memo, (ii) how did the agencies or entities carry out the PCO’s instructions vis-a-vis statistical skewing, (iii) who at each agency or entity signed off on the report of the data?

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)?

With regard to Health Canada’s (HC) approval of the modRNA COVID-19 vaccines manufactured by Pfizer and Moderna and distributed throughout Canada, its mechanism of action and the elements of which they are comprised: (a) how many copies of the modRNA molecule are in a single dose, for both the Pfizer and Moderna products, (i) for adults, (ii) for children; (b) how many copies of the antigen are in a single adult dose of Novavax; (c) if there is a significant numerical difference between the answers for (a) and (b), does this affect the immunological response; (d) how many copies of dsDNA are found in a single 30 microliter adult dose of (i) Pfizer’s product, (ii) Moderna’s product; (e) was a request made to Pfizer-BioNTech and Moderna regarding the DNA size distribution in the vaccine and, if so, (i) what proportion of the total DNA quantity were under 200bp, (ii) what was the average, range and standard deviation; (f) what is the function of the modRNA; (g) what is the function of the lipid nanoparticles (LNPs); (h) what is the specific role(s) of N1-methyl-pseudouridine as used in the modRNA of the vaccines; (i) what safety data was available to HC at the time of approval and is currently available, regarding any and repeat exposure to the following in human cells (i.e., safety, efficacy, toxicity): (i) large amounts of N1-methyl-pseudouridine, (ii) dsRNA, (iii) cytosolic DNA, (iv) lipid nanoparticles; (j) with regard to the research underpinning (g), has a risk assessment been performed of the LNPs separately from that of the drug product for safety, toxicity; (k) does HC have any degradation data for the modRNA in the vaccines and, if so, what does the data show; (l) what is the duration of action of modRNA from the COVID-19 mRNA in the body and how was that measured; (m) in what cells and organs is spike protein most likely to be produced in the body; (n) in which cell types and tissues does the modRNA remain for the longest period of time and second longest period of time, and what are the time periods; (o) for what period of time does a person injected with modRNA produce spike protein; (p) is the production of spike protein dependent on cell type; (q) is there a known correlation between the amount of modRNA in the vaccine and the amount of spike protein produced by the cells; (r) has HC performed a risk assessment on the immunological, toxicological and carcinogenicity of the spike protein and, if so, what was the analysis, and, if not, why weren't these risk assessments considered necessary; (s) if production of spike protein antigen is prolonged for greater than three to five days, does prolonged exposure lead to ongoing production of antibodies; (t) if the answer to (s) is negative, will a study or investigation be undertaken to determine this; (u) if the answer to (s) is affirmative, and if antibodies are the indicator of immunity, why does efficacy wane with time when the antigen production is prolonged; (v) has the purity of the modRNA contained in the COVID-19 vaccines been determined; (w) if the answer to (v) is affirmative, what is the present accepted limit of fragmented and truncated modRNA; (x) if the answer to (v) is negative, why hasn’t the purity of the modRNA been established; (y) if production of spike protein expression is prolonged for more than three to five days, are there harmful sequelae to prolonged exposure; and (z) if the answer to (y) is affirmative, what are those harmful sequelae?

With regard to the government’s response to the COVID-19 pandemic and its reliance on the National Advisory Committee on Immunization (NACI) for their “independent, expert advice” (source: Order Paper question Q-2554): (a) in 2020 and 2021, what specific studies demonstrated that the COVID-19 vaccines would prevent (i) all, (ii) any, transmission of SARS-CoV-2; (b) what specific studies demonstrated that the COVID-19 vaccines were ineffective or would not completely prevent transmission of SARS-CoV-2; (c) in 2020 and 2021, what specific data was provided by the manufacturers of the approved COVID-19 vaccines in Canada that demonstrated that the COVID-19 vaccines were effective in preventing transmission of SARS-CoV-2; (d) with respect to informed consent in 2021, how was the uncertainty or “unknown” evidence around “the effectiveness against virus transmission, and long-term effectiveness against infection and severe disease” communicated to the Canadian public and medical professionals administering the vaccines; (e) without certainty that the vaccine would prevent transmission, what was the rationale provided to the Office of the Prime Minister from the Public Health Agency of Canada, Health Canada or NACI in support of the following measures in relation to only unvaccinated healthy individuals presenting with no symptoms (i) PCR testing before entering the country, (ii) quarantining individuals before entering the country, (iii) showing one’s vaccine status through a vaccine passport, (iv) preventing their travelling on federally-regulated transportation; (f) who advised the Office of the Prime Minister about the uncertainty of the COVID-19 vaccines with respect to its inability to prevent transmission of SARS-CoV2 and when; (g) what was the source of the messaging used by (i) the Chief Public Health Officer, (ii) the Deputy Chief Public Health officer, (iii) the Chief Medical Officer of Health Canada, (iv) the Minister of Health, (v) the Prime Minister, (vi) other government or public health officials, to state that COVID-19 vaccination would protect others, implying it stopped viral transmission; and (h) who approved the messaging in (g)?

With regard to Health Canada’s standards for safety and efficacy for the COVID-19 vaccines: (a) have any COVID-19 vaccines met the requirements of Section C.08.001(2) of the Food and Drug Regulations (2)(g) and (2)(h) for safety and efficacy; (b) has any COVID-19 designated drug or vaccine, approved under Section C.08.001(2.1) of the Food and Drug Regulations, subsequently met the standard for safety and efficacy as delineated in subsection (2)(g) and (2)(h) of Section C.08.001(2); (c) if the answer to (b) is negative, why not; (d) if a COVID-19 designated vaccine has not met (2)(g) and (2)(h) of C.08.001(2), which requires the sponsor to establish safety and efficacy, can the use of the terms “safe and effective” be applied to these vaccines; (e) if the answer to (d) is affirmative, what is the rationale; (f) with regard to the portal on the approval of COVID-19 vaccines for Comirnaty and available information for COMIRNATY - Submission control number 252736 on the Government of Canada's website, is the information for 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods available to the public under the transparency initiatives; (g) if the answer to (f) is negative, why not; (h) as the mRNA vaccines represent a new manufacturing platform, do they meet the requirements of Section C.04.015 of the Food and Drug Regulations; (i) if the answer to (h) is negative, why not; (j) have the Pfizer-BioNTech and Moderna vaccines been assigned to Group 2 Lot Evaluation Group as part of the Lot Release Program; and (k) if the answer to (j) is negative, why not?

With regard to Health Canada (HC) and the initial Pfizer-BioNTech mRNA product and approval process thereof: (a) did HC ask Pfizer to conduct genotoxicity studies to rule out insertional mutagenesis with DNA contamination; (b) if the answer to (a) is negative, why not; (c) what are the dangers with respect to insertional mutagenesis; (d) in the context of the mRNA vaccine, what is the purpose of the lipid nanoparticle (LNP) delivery system; (e) in the context of the mRNA vaccine manufacturing process, (i) what is the purpose of the SV40 enhancer-promoter-ori sequence, (ii) does it include a 72 base pair Nuclear Targeting Sequences (NTS), (iii) if the answer to (ii) is affirmative, what is the purpose of an NTS; (f) with regard to the plasmid map used in the production of the modified mRNA, (i) on what date did the manufacturer provide the map to HC, (ii) what gene annotation was provided; (g) in relation to (f), did the map contain an SV40 promoter-enhancer sequence and a reverse open reading frame; (h) if no plasmid map was received, why did HC not ask for one; (i) according to the response to Order Paper question Q-2266, “There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine,” as part of the residual DNA testing and measurement, (i) what quantity of DNA fragments and SV40 enhancer-promoter fragments per dose were found in the Pfizer product, (ii) who provided the data to HC, (iii) when was this data provided to HC, (iv) is HC aware that the EMA reported a very large variance with respect to the residual DNA levels in the bulk mRNA and that the SV40 enhancer in the promotor sequence is 72 base pairs, (v) if the answers to (i) and (iv) are affirmative, what was HC’s appraisal of this information, (vi) what analytical techniques did the manufacturer rely upon to quantify the amount of RNA and the amount of DNA, (vii) do these quantities meet the “strict limits and controls for the presence of these residual fragments” and what are those limits; (j) as part of HC’s requirements for lot release testing, has HC independently confirmed the quantity of residual DNA and SV40 sequences in the Pfizer-BioNTech product; (k) if the answer to (j) is affirmative, (i) which laboratory and chief scientist provided this independent testing, (ii) what were the amounts recorded, (iii) were these different than those amounts provided by the manufacturer; (l) if the answer to (j) is negative, why was independent testing not completed; (m) is HC aware that Pfizer deliberately removed the SV40 enhancer sequence when reporting the annotated plasmid; and (n) according to HC's response to Order Paper question Q-2266, “The SV40 promoter enhancer sequence… is inactive, has no functional role, and was measured to be consistently below the limit," (i) who provided HC with this assessment, (ii) is there evidence that the SV40 promoter binds to the P53 tumor suppressor gene and affects DNA repair mechanisms, (iii) if the answer to (ii) is affirmative, what are the risks to the health of Canadians as a result?

With regard to Health Canada (HC), the Public Health Agency of Canada (PHAC) or the National Advisory Committee on Immunization (NACI) and the COVID-19 vaccines: (a) when did the (i) Chief Public Health Officer, (ii) Deputy Chief Public Health Officer, (iii) Chief Medical Officer at Health Canada, (iv) Minister of Health at the time, become aware that the COVID-19 vaccines did not prevent transmission of SARS CoV-2; (b) when were any of the federal health agencies in Canada made aware of this information and by who; (c) when was the information described in (a) delivered to (i) the Office of the Prime Minister, (ii) the Privy Council, (iii) the Cabinet, (iv) the members of the House of Commons; (d) what federal entity, ministry or minister first initiated the concept of “COVID-19 vaccine passports”; (e) on what date did the federal government implement vaccine passports for (i) federal employees, (ii) travel restrictions for all unvaccinated Canadians; (f) in 2021 and 2022, did any personnel from HC, PHAC or NACI engage with or share information about the vaccines’ inability to stop transmission of SARS-CoV-2 with any person involved with (i) the World Health Organization’s Strategic Group of Experts, (ii) Vaccines Together, (iii) the International Vaccine Institute, (iv) Dr. Hanna Nohynek, the World Health Organization’s Chair of Strategic Group of Experts on Immunization; and (g) if the answers to (f)(i) through to (f)(iv) are affirmative, what were the summaries of those discussions or correspondences in relation to the transmission question and the validity of vaccine passports?

With regard to Health Canada’s (HC) approach when they suspect that a vaccine manufacturer has potentially adulterated their own product without appropriate disclosure to HC: (a) how does HC confirm that the potential adulteration exists; (b) does HC procure independent labs to assess the potential adulteration; (c) what measures are available to HC to ensure safety to Canadians and the environment in the event of a deception or adulteration of a therapeutic product under the Food and Drugs Act; (d) regarding the Pfizer/BioNTech mRNA vaccine, were any measures taken under the Food and Drugs Act or under any contract or other regulation with regard to the discovery in July 2023 of the SV40 enhancer/promoter sequences well after the full authorization of this vaccine; (e) if the answer to (d) is affirmative, what measures were taken; (f) if the answer to (d) is negative, why weren’t measures taken; and (g) if the answer to (d) is negative, are measures being planned?

With regard to Health Canada’s approval of the COVID-19 modRNA vaccines (modified with N1-methylpseudouridine) for pregnant women: (a) what specific research data supported the claims that (i) this product may be safely administered at any stage of pregnancy, (ii) this product protects pregnant women from SARS-CoV-2 infection and severe disease, (iii) the vaccinated mother is less likely to transmit SARS-CoV-2 to her newborn after delivery compared to an unvaccinated mother, (iv) the modRNA vaccine, and consequently the spike protein, do not excrete into breast milk, (v) the modRNA, and consequently the spike protein, do not cross the placental barrier, (vi) all modRNA is destroyed in the human body within about two days, (vii) there is no possibility that the modRNA vaccine contents will enter the cell nucleus and modify the human genome; (b) with respect to the claims in (a), has Heath Canada modified these claims based on updated scientific research, and if so, which claims and how; (c) what is the real-world data indicating that this product presents no safety concerns for the pregnant woman or the developing fetus or newborn; (d) what is the quantitative threshold for a concerning safety signal for these cohorts; (e) how has the monograph for the COVID-19 modRNA vaccines been updated in relation to pregnancy and lactation to convey this safety research data; and (f) when were these updates made?

With regard to Health Canada’s approval of mRNA vaccine products: (a) can Health Canada definitively exclude the possibility that undesirable effects to human cells and tissues (e.g. cell proliferation, toxicity) may be caused by conceivable mechanisms of action, such as (i) the creation of aberrant proteins by means of ribosomal frameshifting, (ii) the concomitant injection of residual DNA plasmid fragments, which, according to Speicher et al., are known to exceed by 188 to 509 fold the guideline limits for residual DNA that the United States Food and Drug Administration and the World Health Organization set at 10 ng/dose when measured by fluorometry, and the subsequent transfection of these fragments into the cell’s nucleus with the help of the lipid nanoparticles (LNPs), (iii) the concomitant injection of other contaminants such as double-stranded RNA or fragmented RNA, (iv) the presence of abnormally high levels of IgG4 antibodies due to repeated vaccination, (v) the concomitant injection of bacterial endotoxins previously detected in Pfizer and Moderna vials, which may also be transfected via LNPs, (vi) the potential for reverse transcriptase of mRNA into DNA, (vii) the presence of SV40 promoter/enhancer DNA as an additional contaminant that could transfect the cell and integrate into the genome, (viii) the LNP-facilitated entry of mRNA and spike protein across the blood-brain barrier, across the placenta, into breast milk, and into organs and tissues, particularly of the heart, bone marrow and brain; (b) when considering the mechanisms of action in (a), can Health Canada definitively exclude the possibility that any combination of two or more of these mechanisms may cause undesirable effects of cell proliferation or toxicity; (c) has Health Canada completed a risk-benefit assessment in relation to (i) each of these singular mechanisms of action, (ii) the combination of any of the mechanisms listed in (a); (d) if the answer to (c) is affirmative, what is the risk-benefit assessment; (e) if the answer to (c) is negative, why has Health Canada not completed a risk-benefit assessment; and (f) did Health Canada set new safety limits for levels of residual DNA in the presence of a lipid nanoparticle delivery system in an mRNA vaccine product?

With regard to the government authorization of mRNA COVID-19 vaccines: (a) when did Health Canada (HC), the Public Health Agency of Canada (PHAC), and the National Advisory Committee on Immunization (NACI), receive documentation from Pfizer acknowledging the presence of SV40 enhancer promoter sequence and SV40 poly(A)tail signal sequence in their vaccine BNT162b2; (b) with respect to the documentation related to (a), (i) how can the documentation be accessed, (ii) when was it received by HC, PHAC and NACI, (iii) was this documentation obtained before or after the BNT162b2 vaccine was authorized; (c) has HC asked Pfizer about the safety of the SV40 enhancer promoter sequence and SV40 poly(A)tail signal sequence in their vaccine, and, if not, why not; (d) if the answer to (c) is affirmative, what are the risk analyses that Pfizer did, if any, regarding these SV40 sequences; (e) what amount of SV40 sequences is considered safe (i) in a single Pfizer mRNA vaccine dose for distinct age groups, (ii) for repeated vaccine injections over time per each age group considered; (f) what were HC’s regulatory guidelines surrounding SV40 sequences in a vaccine prior to 2019; (g) what are the current (relevant for the period of 2019-2024) regulatory guidelines surrounding SV40 sequences in a conventional vaccine and in an mRNA vaccine; (h) how does HC know the SV40 fragments are inactive and have no functional role in mRNA vaccines; (i) has HC verified the amount of SV40 enhancer promoter sequence and SV40 poly(A)tail signal sequence in any of the Pfizer or Moderna mRNA vaccines, including the Pfizer XBB, and, if not, why not; (j) if the answer to (i) is affirmative, what was the outcome of this verification and how was this verification done; (k) what is HC’s official position with respect to the increased risk of DNA contaminants getting into human cells, including the cell nucleus, when encapsuled in liposomes, as is the case with the mRNA vaccines; (l) how has HC confirmed with certitude there is no genetic integration (i.e. in vivo transfection into the nucleus of human cells) of DNA plasmid fragments, which may or may not contain SV40 sequences, as found in either mRNA vaccine; (m) does the publicly undisclosed presence of SV40 sequences or any other adulteration (e.g. reverse open reading frames [ORF]) violate the terms and conditions of the Pfizer and Moderna contracts, and, if not, why not; and (n) if the answer to (m) is affirmative, what are the consequences?

With regard to Health Canada’s authorization of COVID-19 vaccines, at the time of approval through the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in 2021: (a) was there evidence that the vaccines stopped people from transmitting the virus to others and, if (i) affirmative, what is the evidence, (ii) negative, what is the evidence for public messaging suggesting that herd immunity was achievable through mass vaccination; (b) why was the early initiative to track seroconversion of Canadians against SARS CoV 2 abandoned and the task force for this dissolved; and (c) why was naturally-acquired immunity not considered an appropriate form of immunity against SARS-CoV-2?