Questions and responses 44th Parliament, 1st session November 22, 2021, to January 6, 2025

With regard to COVID-19 vaccines procured by the government: (a) what are the government's estimates regarding how many vaccine doses were not administered; and (b) what is the breakdown of (a) by reason (expired, wasted, improperly stored, etc.) and by vaccine manufacturer (Moderna, Pfizer, etc.)?

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 COVID-19 vaccines, including boosters, purchased by the government for delivery in 2023: (a) how many doses did the government procure for an expected delivery in 2023; and (b) of the doses in (a), how many does the government project will be (i) administered to Canadians, (ii) donated to foreign countries, (iii) discarded?

With regard to COVID-19 vaccine doses procured by the government, and broken down by manufacturer (Pfizer, Moderna, etc.): (a) how many doses obtained by the government have been delivered to Canada but have yet to be administered as of June 15, 2022; (b) how many doses are set to be delivered between June 15, 2022, and the end of September 2022; (c) of the doses currently on hand in (a), how many are set to expire each month until the entire batch is expired; and (d) of the doses scheduled to be delivered in (b), when are those doses scheduled to expire?

With regard to COVID-19 vaccine doses procured by the government, broken down by manufacturer (Pfizer, Moderna, etc.): (a) how many doses obtained by the government have been delivered to Canada but have yet to be administered as of October 27, 2022; (b) how many doses are set to be delivered between October 27, 2022, and the end of January 2023; (c) of the doses currently on hand in (a), how many are set to expire each month until the entire batch is expired; and (d) of the doses scheduled to be delivered in (b), when are those doses scheduled to expire?

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 (HC) and the Public Health Agency of Canada (PHAC): (a) what do HC and PHAC know about the origins of COVID-19; and (b) how and when was the knowledge in (a) obtained?

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 government approval of the mixing and matching of COVID-19 vaccines (heterologous vaccination): (a) what data did the manufacturers of the Pfizer, Moderna and AstraZeneca COVID-19 vaccines have with respect to mixing their products with other COVID-19 vaccine products; (b) in mid-2021, when Health Canada (HC), the Public Health Agency of Canada (PHAC) and the National Advisory Committee on Immunization (NACI) were recommending mixing vaccines to Canadians, what did the Pfizer, Moderna and AstraZeneca COVID-19 vaccine monographs recommend at that same time; (c) what scientific rationale did HC, the PHAC and the NACI have for heterologous vaccination, broken down by (i) Pfizer mRNA vaccine and Moderna mRNA vaccine, (ii) mRNA vaccine and adenovirus vaccine; (d) what advice or instruction did the government receive from the World Health Organization’s Chief Scientist, Dr. Soumy Swaminathan, regarding the safety and efficacy of this approach in July 2021; (e) with respect to the advice in (d), did HC follow that advice and, if not, why not; (f) what data regarding the safety and risks of heterologous vaccination in Canadians (i) did the PHAC, the NACI or HC have at the time mixing was recommended, (ii) does the PHAC, the NACI or HC have currently; (g) with respect to the Canadian study related to the mixing and matching of COVID-19 vaccines, when will the results of the MOSAIC trials (CT24) NCT04894435 sponsored by the Canadian Immunization Research Network become available; (h) with respect to the study in (g), what are the interim results; and (i) with respect to the study in (g), what are the final results, if anything?

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 COVID-19 mRNA vaccine safety and efficacy: (a) has Health Canada (HC) 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) if HC has reviewed the study in (a) what is their assessment; (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 (VISP); (d) how many death claims relating to the COVID-19 vaccines have been made to date through the VISP; (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 out through the VISP and what is that total amount paid out; (g) is an autopsy required in the case of a vaccine injury death claim; (h) if (f) is affirmative, what specialized immunohistochemistry (IHC) is required to prove causation in the event of an mRNA vaccine injury death; and (i) has HC considered mandating autopsies with appropriate IHC staining for sudden deaths?

With regard to Health Canada’s (HC) approval of mRNA vaccines for pregnant and lactating women, and children, youth, and adults of reproductive age: (a) what is the cause of the reported menstrual irregularities in vaccinated women; (b) what is the safety data on any single exposure and repeated exposure to lipid nanoparticles (LNP) for (i) pregnant women, (ii) unborn fetuses; (c) do LNPs, spike protein encoding mRNA, or spike protein pass through the placenta; (d) if the answer to (c) is affirmative, does this present a safety concern to the unborn fetus, and how was this determined; (e) where are LNPs, mRNA, or spike protein distributed in the fetus; (f) what are the potential genetic effects of the COVID-19 vaccine with respect to the epigenetic effects on germ cells; (g) what are the specific references confirming that mRNA is not integrated into the genome or genetic material of the oocyte or the sperm; (h) how, and for how long, does HC actively monitor or plan to actively monitor the impact of the dose-dependent effect of the vaccine on future fertility in (i) vaccinated women and men of child-bearing age, (ii) vaccinated children, (iii) children exposed in utero to the COVID-19 vaccines following maternal injection; (i) does HC actively monitor or plan to actively monitor the adverse effects of the mRNA vaccination, and for how long, in the (i) pregnant mother, (ii) fetus; (j) if the answer to (i) is affirmative, does this or will this include miscarriages, uterine deaths, possible illnesses and birth malformations; (k) with respect to studies analyzing various components and products of COVID-19 vaccination, including spike protein, what have been the findings comparing placental tissue and breast milk from vaccinated and non-vaccinated mothers, and what are the specific references; (l) based on available research and real-world data, what updated written guidance has HC provided to provinces and territories regarding information which is given to pregnant women prior to and after vaccination, their doctors (neonatal doctors, paediatricians, fertility doctors, obstetricians), other medical staff (including midwives), and vaccinators with respect to (i) the potential adverse events to monitor post-injection, (ii) their duty to report adverse events and where; and (m) does the guidance in (l) include the updated mRNA vaccine monographs and where to find them?

With regard to COVID-19 vaccines thrown away due to spoilage or expiration: what was the available national wastage rate between May 1, 2021, and April 21, 2022, including the (i) percentage of doses wasted, (ii) number of doses wasted, (iii) number of doses administered?

With regard to government statistics on injuries caused by COVID-19 vaccines: (a) what is the number of vaccine-related injuries reported to date, in total, and broken down by level of severity and type of injury; and (b) what is the breakdown of (a) by vaccine and manufacturer?

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 the COVID-19 vaccine doses procured by the government: (a) how many doses purchased are known to have (i) been lost or stolen, (ii) expired, broken down by manufacturer; and (b) what are the details of each instance where doses were lost or stolen, including, for each, the (i) date, (ii) number of doses, (iii) manufacturer, (iv) location, (v) incident summary?

With regard to COVID-19 transmission within Canada: (a) how many Canadians are known to have contracted COVID-19 while on a domestic flight (i) between July 1, 2020, and July 1, 2021, (ii) between July 1, 2021, and October 29, 2021, (iii) between October 30, 2021, and November 29, 2021, (iv) since November 30, 2021; (b) how many Canadians are known to have contracted COVID-19 while in an airport (i) between July 1, 2020, and July 1, 2021, (ii) between July 1, 2021, and October 29, 2021, (iii) between October 30, 2021, and November 29, 2021, (iv) since November 30, 2021; (c) how many Canadians are known to have contracted COVID-19 while on a VIA Rail train (i) between July 1, 2020, and July 1, 2021, (ii) between July 1, 2021, and October 29, 2021, (iii) between October 30, 2021, and November 29, 2021, (iv) since November 30, 2021; and (d) how many Canadians are known to have contracted COVID-19 while in a VIA Rail train station (i) between July 1, 2020, and July 1, 2021, (ii) between July 1, 2021, and October 29, 2021, (iii) between October 30, 2021, and November 29, 2021, (iv) since November 30, 2021?

With regard to the statement in the government’s response to Order Paper question Q-3082, that “$132,168 was spent in 2021-22 to plan and deliver a social media influencer campaign to help people in Canada make an informed decision about COVID-19 vaccines”: (a) which influencers were paid as part of this campaign; (b) how much was each influencer paid, broken down by influencer; (c) what is the itemized breakdown of how the $132,168 was spent; and (d) for 2020-21, what are the details of the campaign, including (i) how much money was spent, (ii) which influencers were paid as part of this campaign, (iii) how much was each influencer paid, broken down by influencer, (iv) what is the itemized breakdown of how the $132,168 was spent?

With regard to communications sponsored by the government during the COVID-19 pandemic: (a) which individual or agency developed the “Pregnancy, childbirth and caring for a newborn during the COVID-19 pandemic” communication which was first published on July 13, 2021, and last updated on October 25, 2023; (b) who provided the final approval of the communication in (a) and when; (c) which individual or agency developed the narrative for the video titled “Are there any ingredients in the COVID-19 vaccines that I should be concerned about”, narrated by Dr. Ayesha Raza, family physician and women’s health specialist, about the ingredients of the COVID-19 vaccine and how long these vaccines stay in the body, i.e., “they leave the body shortly after vaccination”; (d) who provided the final approval of the communication in (c) and when; (e) which individual or agency developed the narrative for the video titled “Can the COVID-19 vaccines affect fertility”, narrated by Dr. Darine El-Chaâr, maternal fetal medicine specialist at the Ottawa Hospital, and sponsored by the government; (f) who provided the final approval of the communication in (e) and when; (g) on December 23, 2021, which individual or agency developed the advice to Canadians about the interchangeability of vaccines found on the government's website, titled “COVID-19 vaccine: Canadian Immunization Guide, For health professionals, Notice”; and (h) who provided the final approval of the communication in (g) and when?

With regard to the ArriveCAN application: (a) how much money did the government spend developing the application; (b) what is the itemized breakdown of all expenditures related to (a); (c) how much has been spent to date maintaining, updating, or promoting the application; (d) how much money did Shared Services Canada spend to initially develop this application; (e) what is the itemized breakdown of all expenditures related to (d); (f) what are the details of all contracts signed by the government related to the application in any way, including, for each (i) the vendor, (ii) the date, (iii) the value, (iv) the start and end dates, if applicable, (v) the description of goods or services provided, (vi) whether the contract was sole-sourced or awarded through a competitive bidding process; and (g) what is the total cumulative cost (i) incurred to date, (ii) budgeted related to the application?