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- NCI-R-02- Item-1-0 | National Citizens Ar
VOLUME 1 Volume 1 Volume One contains the six section fo the report which outline the following sections: 1. Executive Summary 2. The Pandemic 3. National Citizens Inquiury 4. Objectives of the Inquiry 5. Procedures 6. Public Hearings Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
- NCI-R-02-Item-11-1 | National Citizens Ar
11. Transcripts Table of Contents VOLUME THREE Transcripts Introduction Opening Statements Witness Testimony About the Transcripts Page numbers have been included in the original transcripts to facilitate ease of reference and navigation for readers. Table of Contents Witness Transcripts 1 Truro, Nova Scotia Part 1 of 9 2 Day 1 5 Day 2 149 Day 3 329 Toronto, Ontario Part 2 of 9 521 Day 1 524 Day 2 678 Day 3 868 Winnipeg, Manitoba Part 3 of 9 1032 Day 1 1035 Day 2 1184 Day 3 1409 Saskatoon, Saskatchewan Part 4 of 9 1591 Day 1 1594 Day 2 1757 Day 3 1947 Red Deer, Alberta Part 5 of 9 2124 Day 1 2127 Day 2 2313 Day 3 2614 Vancouver, British Columbia Part 6 of 9 2796 Day 1 2799 Day 2 2965 Day 3 3139 Quebec City, Quebec Part 7 of 9 3309 Day 1 3312 Day 2 3476 Day 3 3681 Ottawa, Ontario Part 8 of 9 3873 Day 1 3876 Day 2 4049 Day 3 4249 Virtual Hearings Part 9 of 9 4576 Virtual Hearing 1 4577 Virtual Hearing 2 4627 Virtual Hearing 3 4646 1. Transcripts 11.1 Introduction The inclusion of full transcripts of each of the witnesses as part of the official record is an essential component of the Commission‘s work. These transcripts serve to preserve the firsthand accounts, opinions, experiences, and perspectives of those directly impacted by or involved in the issues under investigation. Process of Transcription: The transcription process involved the detailed recording of all verbal testimony given by the witnesses during the hearings. A team of volunteer transcribers, utilized both manual (human) or automated (AI-based) methods, as well as multi-levels of manual reviews to ensure accuracy and efficiency. Every word is documented in the transcript, preserving the tone and context of the testimony. Quality Assurance: Transcripts are carefully reviewed for accuracy. This may involve listening to the recorded testimony multiple times and correcting any errors. In some cases, unclear or disputed sections may be annotated within the transcript. Importance of Transcripts: The transcripts serve multiple purposes. They provide a permanent, verifiable record of the hearings. This is important for ensuring the transparency and accountability of the Commission‘s work. It also allows those who were not present at the hearings to access the information presented. Furthermore, transcripts can serve as a valuable resource for future research, policy development, and historical record. They ensure that the experiences and voices of the witnesses are preserved for posterity, contributing to our collective understanding of the issues investigated by the commission. In this way, the transcription process provides a meticulous, enduring account of the testimonies provided by the witnesses. It plays a vital role in preserving the evidence, upholding the integrity of the Commission‘s proceedings, and informing future generations. 11.2 Opening Statements We are proud to present full transcripts of the opening statements made at each of the eight hearings held across Canada as part of this Commission‘s proceedings. While these statements are not direct testimonies from witnesses, they hold significant value and form an integral part of our understanding of the proceedings. The opening statements set the tone for each hearing, encapsulating the mood, context, and undercurrents of the deliberations that followed. Delivered by key figures in the Commission, these remarks provide insights into the purpose, motivations, and aspirations of the Inquiry. They elucidate the themes that emerged in each hearing, illuminating the unique character and concerns of the various communities involved. These transcripts offer an opportunity for readers to delve into the emotions, reflections, and aspirations that framed each of the eight hearings. They capture the intensity, hope, and commitment that defined the opening moments of each session. Each opening statement is a call to attention and a pledge of dedication to the truth-seeking mandate of the Commission. The Commissioners have underscored the importance of these opening statements as part of the official record. Their inclusion reflects our commitment to preserving a complete and nuanced account of the proceedings. It is our hope that these transcripts will serve not only as a historical record but also as a source of insight and understanding for future generations as they reflect on this pivotal period in our national journey. With the availability of these opening statement transcripts, we invite you to immerse yourself in the spirit and resolve that catalyzed each hearing, deepening your understanding of the proceedings and the invaluable contributions made by all involved. 11.3 Witness Testimony We are honoured to present to you the complete transcripts of the testimonies provided by both lay and expert witnesses during the hearings of this Commission. These accounts form the heart of our proceedings, encapsulating a wealth of experience, knowledge, and insight that has been crucial to our understanding of the issues at hand. Lay witnesses—those individuals who have lived through the events under investigation—provide personal, firsthand accounts that breathe life into our understanding of these experiences. Their testimonies paint a vivid picture of the human impact of these events, revealing the deeply personal and often poignant realities that lay behind the facts and figures. These accounts provide an invaluable perspective that helps us appreciate the complexity and the human dimension of the issues we are exploring. Expert witnesses, on the other hand, provide a different yet equally valuable perspective. Drawn from various fields such as healthcare, education, law, and social sciences, these individuals offer insights grounded in extensive study, research, and professional experience. Their testimonies help us to understand the broader context, uncover underlying mechanisms, and explore potential solutions. Both types of testimonies—lay and expert—are integral to our investigation. Together, they offer a nuanced and multifaceted understanding of the subjects at hand. The dialogue between personal experience and professional expertise deepens our appreciation of the complexity of the issues under review, informing our deliberations and guiding our recommendations. The transcripts of these testimonies, painstakingly prepared by our dedicated volunteer transcription team, offer an accurate, detailed, and enduring record of these proceedings. They ensure that the voices heard during the hearings continue to resonate, informing and inspiring future discussions and decisions. As you explore these transcripts, we invite you to reflect on the diverse perspectives, experiences, and insights they represent. These are the voices that have shaped our work, and we hope they will also shape your understanding of the important issues that have been brought before this Commission. 11.4 About the Transcripts Our transcription volunteer team was a dedicated group of individuals who committed their time and expertise to support the essential work of this Commission. Their collective mission was to ensure the accurate and comprehensive documentation of each witness‘s testimony, preserving their stories and contributing to a deeper understanding of the issues at hand. This team was comprised of a diverse and skilled group, including both professional transcriptionists and individuals with strong listening and typing skills from various backgrounds. They were united by their shared dedication to accuracy, attention to detail, and respect for the content they handled. Our volunteers understood the importance of their role in this process. They were committed to translating the spoken word into text with the utmost care, maintaining the tone and intent of the original statement, and ensuring that every voice was accurately represented. Their work played a critical role in ensuring transparency, promoting accessibility, and preserving the historical record of these proceedings. Through their efforts, we maintained a thorough and lasting account of the testimonies presented to the Commission, contributing to our collective understanding and memory of these impactful events. In recognition of their dedication and important contributions, we extend our deepest gratitude to our volunteer transcription team. Their unwavering commitment to this task reflected the spirit of service, civic engagement, and commitment to truth that was central to the work of our Commission. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
- NCI-R-03-Item-6-1-3 | National Citizens Ar
6.1.3 International Health Regulations and Treaties Update 6.1.3 International Health Regulations and Treaties Update Recommendations Safeguarding Sovereignty and Autonomy Recommendation : Ensure National Oversight and Decision-Making Implementation : Establish a national review board comprising public health experts, legal advisors, and representatives from civil society to oversee and evaluate any WHO declarations and recommended measures before they are implemented domestically. This board should have the authority to approve, modify, or reject WHO recommendations based on national interests and contextual factors. Rationale : This approach requires that international directives are tailored to the specific needs and circumstances of Canada, preserving national sovereignty while participating in global health initiatives. Recommendation : Advocate for Clear and Specific Criteria for Emergency Declarations Implementation : Work with other WHO member states to refine the definition of a pandemic emergency within the IHR. Ensure that the criteria for declaring an emergency are specific, transparent, and based on robust scientific evidence and risk assessment. Rationale : Clear criteria will prevent the arbitrary or politically motivated declaration of emergencies and ensure that such declarations are based on concrete data and genuine public health threats. 2. Addressing Financial Burdens Recommendation : Negotiate Fair Contribution Frameworks Implementation : Engage in negotiations to establish a fair and proportional financial contribution framework for global health initiatives. Contributions should be based on each country’s GDP, public health expenditure, and capacity to contribute, thus ensuring that the financial burden is equitably distributed. Rationale : This ensures that wealthier nations like Canada contribute fairly without compromising their domestic health priorities and financial stability. Recommendation : Enhance Accountability and Transparency in Funding Utilization Implementation : Implement stringent accountability mechanisms to track and report on the utilization of funds contributed to global health initiatives. Regular audits and public disclosures should be mandatory. Rationale : Ensuring transparency in how funds are used will build trust and that contributions are used effectively and efficiently in achieving intended public health outcomes. 3. Protecting Civil Liberties Recommendation : Enact Strong Legal Safeguards Implementation : Develop and enact legal safeguards to protect civil liberties during public health emergencies. These should include strict criteria for the invocation of emergency powers, time limits on restrictive measures, regular reviews by independent judicial bodies, and the imposition of criminal penalties against the offending officials should violations be determined. Rationale : Protecting civil liberties ensures that public health measures do not lead to unnecessary or prolonged restrictions on personal freedoms and rights. Recommendation : Establish Independent Oversight Mechanisms Implementation : Create independent oversight bodies to monitor the use of emergency powers and public health measures. These bodies should include representatives from the judiciary, civil society, and human rights organizations. Rationale : Independent oversight will help prevent abuse of power and provide measures that are proportionate, necessary, and in line with human rights standards. 4. Ensuring Transparency and Accountability Recommendation : Promote Open and Inclusive Decision-Making Processes Implementation : Ensure that WHO decision-making processes are transparent and inclusive; involve a wide range of stakeholders; and include member states, public health experts, and civil society organizations. Regular public consultations and disclosures should be mandated. Rationale : Transparency and inclusivity in decision-making processes build trust where diverse perspectives are considered—leading to more balanced and effective public health policies. Recommendation : Strengthen Whistleblower Protections Implementation : Implement robust protections for whistleblowers who report on public health issues, corruption, or misuse of power within international health organizations and domestic health institutions. Rationale : Protecting whistleblowers encourages the reporting of wrongdoing and ensures that issues are addressed promptly, thereby maintaining the integrity of public health responses. 5. Balancing Global and Domestic Responsibilities Recommendation : Prioritize Domestic Public Health Needs Implementation : While contributing to global health initiatives, safeguard priority of public health needs. Establish clear guidelines for balancing international commitments with national health priorities. Rationale : Maintaining a balance between global responsibilities and domestic needs ensures that Canadians’ health and well being are not compromised while supporting global health efforts. Recommendation : Foster Global Partnerships and Collaborations Implementation : Develop partnerships with other countries and international organizations to share best practices, resources, and expertise. Participate in joint research and development initiatives to enhance global and national health capacities. Rationale : Collaborative efforts can lead to more effective and sustainable public health outcomes, benefiting both Canada and the global community. By implementing these recommendations, Canada can mitigate the risks associated with the proposed IHR amendments and the global pandemic treaty. These measures ensure that national sovereignty, financial stability, civil liberties, transparency, and accountability are upheld while contributing effectively to global public health efforts. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
- NCI-R-01-Item-1-9 | National Citizens Ar
Conflict of Interests for the Approval of Experimental Vaccines Interim Authorization of Covid-19 Vaccine Introduction The Commission received detailed information about the procedure through which "approval" for COVID-19 vaccines was granted in Canada. According to the testimony, the conventional evaluation and endorsement process for the COVID-19 vaccines was not adhered to by the Canadian Government. Instead, a new process was established whereby Health Canada "authorized" the Covid-19 vaccines under an Interim Order (which was later adopted as a permanent regulation). It is important to understand that the Covid-19 vaccines were never approved under the traditional approval process for drugs in Canada. Under the alternative authorization process, the necessity to establish the safety and efficacy of Covid-19 vaccines through an objective manner appears to have been set aside. Objectively and independently proving the safety and efficacy of any new drug before its introduction into the market is an essential cornerstone of responsible healthcare and public safety. This rigorous requirement serves as a critical safeguard for individuals' well- being, ensuring that potential risks are thoroughly assessed and weighed against the benefits. This principle becomes even more pivotal when the drug is intended for widespread use across all segments of the population. The blanket use of a drug, especially one like the Covid-19 vaccines, necessitates an unassailable foundation of evidence. Rigorous testing, transparent evaluation, and independent verification of safety and efficacy are fundamental to instilling trust among both healthcare professionals and the general public. This approach ensures that medical interventions are based on the most accurate and reliable information available. In the context of a global health crisis, these principles are vital to ensuring that public health measures are not only effective but also respectful of individuals' rights and dignity. It is imperative that all drugs proposed to be released to the public be objectively and independently proven to be both safe and effective. It is for this reason that strict proof of safety and efficacy have been required by our drug approval regulations. The need to prove both safety and efficacy take on particular importance for drugs intended for the entire population, including children and pregnant women. This approach forms the bedrock of responsible medical practice and contributes to a society that values health, science, and the dignity of each person. Testimony Concerning Interim Authorization of Covid-19 Vaccines The following vaccines were authorized by Health Canada under the Interim Order: Pfizer-BioNTech on December 9, 2020 for ages 16 and older, and May 5, 2021 for ages 12-15; Moderna on December 23, 2020 for ages 18 and over and August 27, 2021 for ages 12-17; AstraZeneca on February 26, 2021 for ages 18 and older, and Janssen (Johnson & Johnson) on March 5, 2021 for ages 18 and older. The Commission received testimony from two key witnesses, Shawn Buckley and Deanna McLeod, regarding the procedure through which the authorization of Covid-19 vaccines took place in Canada. The initial authorization of all Covid-19 vaccines was provided under a temporary, Interim Order, which exempted them from the traditional regulations that demand manufacturers to demonstrate objective evidence of safety and effectiveness. The result was that while chief medical officers across the country repeatedly assured Canadians that the Covid-19 vaccines were "safe and effective" - the general Canadian population had no understanding that their authorization process had not required objective proof of safety nor efficacy. Shawn Buckley The Political Approval of the Covid Vaccine: A Constitutional Lawyer's Perspective The normal regulatory process for approving a new drug in Canada is set out in Division 8 of Canada's Food and Drug Regulations (the "Regulations”). To receive approval for a new drug in Canada, the Regulations require evidence of both the drug's safety and effectiveness be demonstrated to the Minister of Health. Once evidence of safety and efficacy is provided, the Minister considers whether the benefits outweigh the risks. If evidence of safety and effectiveness has been provided that shows the benefits outweigh the risk, the Minister may grant market approval of a new drug. These first steps of demonstrating safety and effectiveness, before approval, are essential to ensuring that Canadians are not exposed to unknown risks in the name of unknown effectiveness. The Federal Government’s creation of the Interim Order required Health Canada to approve the Covid-19 vaccines without proof of either safety or of efficacy which resulted in millions of Canadians taking a new drug whose safety and effectiveness could not be known. The unfortunate result of authorizing the Covid-19 vaccines through the Interim Order (instead of under the traditional approval process under the Regulations) was revealed through NCI testimony – many Canadians were injured or killed, while at the same time the Covid-19 vaccine was revealed not to be effective in preventing infection and transmission nor reducing the severity of illness. The benefit of hindsight demonstrates clearly why the traditional tests under the Regulations are needed for all new drug approvals, and why Canada should not authorize drugs under Interim Orders, even in cases of public health emergencies. The Traditional Drug Approval Process The requirements that must be met to approve a new drug in Canada are found in C.08.002(2) of the Regulations. Of particular importance are high requirements for proof of both safety and efficacy. These are found as follows: C.08.002(2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following: detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended; substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended[.] Under the traditional approval process in the Regulations the first step is to establish the safety profile of the new drug and demonstrate to the Minister of Health that the drug is safe for use in the human population. The second step is to establish the new drug’s benefit profile, in other words, is it effective, does it work. The third step, although not specifically included in the regulation, is to evaluate the Risk / Benefit profile for the drug. In other words, the regulatory review has to establish that the benefits of using the drug outweigh the risk of using the drug. One cannot satisfy the requirement for a risk/benefit analysis without a complete understanding of the drug's safety and benefit profile. Interim Order: Importation, Sale and Advertising of Drugs in Relation to COVID-19 Instead of following the Regulations, on September 16, 2021, the Minister of Health made an Interim Order exempting all Covid-19 drugs (including Covid-19 vaccines) from the normal review and approval process. The Interim Order was made under section 30.1 of the Food and Drugs Act, R.S.C., 1985, c. F-27, which permits the Minister of Health to make an interim order that overrides normal regulations. The section reads: 30.1 (1) The Minister may make an interim order that contains any provision that may be contained in a regulation made under this Act if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. The term “significant risk” is not defined in the Act, nor is there any proportionality built into this section. Thus, there do not appear to be any legislative safeguards or guidelines for when this power to override is used by the Minister of Health. Under this broad power, the Minister made the Interim Order which, rather than requiring significant evidence of safety and efficacy of the Covid-19 vaccines as mandatory requirements for approval, only required the vaccine manufacturers to provide: 3(1) … sufficient information and material to enable the Minister to determine whether to issue the authorization, including … (o) the known information in relation to the quality, safety and effectiveness of the drug. By letting the Minister make a decision based on "known information" about safety and effectiveness, this allowed the Covid-19 vaccines to be authorized in advance of actual knowledge about their safety or effectiveness. The Interim Order attempted to make up for this by having manufacturers promise to do more follow-up research as follows: 3(2) If, at the time an application is initially submitted to the Minister, the applicant is unable to provide information or material referred to in any of paragraphs (1)(g) to (k) and (m) to (o) or that information or material is incomplete, the applicant must include in the initial part of the application a plan as to how and when they will provide the Minister with the missing information or material. However, as will be discussed further below, the Interim Order also prevented the Minister from revoking authorization once given, meaning that the Minister was absolved of the responsibility to protect the public if subsequent safety problems were discovered in the Covid-19 vaccines. It is vital to recognize that when the Interim Order was issued, the Minister of Health at the time had attended Lakehead University, graduating with a Bachelor of Arts, and had received a Master of Public Administration from the University of Victoria. To our understanding, the minister possessed no medical training credentials that we would consider pertinent to making the required determinations under the regulations. Approval of Covid-19 Vaccines was virtually guaranteed under the Interim Order Remarkably, the Interim Order effectively required Health Canada to authorize a Covid-19 vaccine for use in the Canadian population even in the absence of detailed evidence of safety and substantial evidence of efficacy. Section 5 of the Interim Order provides: The Minister must issue an authorization in respect of a Covid-19 drug if the following requirements are met: the applicant has submitted an application to the Minister that meets the requirements set out in subsection 3(1) or 4(2); the applicant has provided the Minister with all information or material, including samples, requested under subsection 13(1) in the time, form and manner specified under subsection 13(2); and the Minister has sufficient evidence to support the conclusion that the benefits associated with the drug outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the necessity of addressing the urgent public health need related to Covid-19. The test set out in (c) above is startling when compared to the traditional test for new drugs under the Regulations. Under the traditional test, evidence of safety and efficacy must be proven. Under the Interim Order, there only needs to be "evidence to support the conclusion" that the benefits outweigh the risks. This does not mean the Minister (i.e., Health Canada) has to be convinced and actually reach the conclusion. If the test was to convince Health Canada, the test would read: the Minister has sufficient evidence to conclude The difference in language is important. Under this test, it appears that a vaccine would have to be authorized as long as there was sufficient evidence to support an argument that the benefits outweighed the risks. In addition, the risk versus benefit test need not be robust, as the Minister is to "have regard" for the "uncertainties" of the benefits and risks. It is not clear how the Minister is expected to perform a risk versus benefit analysis when there is insufficient safety and efficacy evidence to determine true risks versus benefits. It is even more unclear how to perform a risk versus benefit analysis while "having regard to the uncertainties" of the risks versus benefits. Ultimately, the Interim Order reveals that the Minister's priority was the "necessity of addressing the urgent public health need related to Covid-19." The problem, of course, is that under this test, the government placed its perceived "urgent public health need" ahead of safety and efficacy of the Covid-19 vaccines. This appears to be what the Government of Canada actually did. Regardless of whether the need for a drug is urgent, this cannot override a proper assessment of safety, particularly when Canadians are under the impression that a drug has been proven safe. The NCI was not made aware of any public health authority in Canada cautioning Canadians that the vaccines had been authorized without the traditional need to prove their safety. Instead, the Government of Canada was under enormous pressure in the media to secure vaccines and make them available to Canadians. In response, it placed orders for millions of doses from the manufacturers. This placed the Government in a conflict of interest because it had purchased and imported unapproved vaccines while it waited for itself to approve the vaccines. The Interim Order appears to have been designed to ensure that the vaccines would have no problem in receiving authorization. As indicated above, in the traditional drug approval process, chances are not taken. If there is uncertainty about either safety or efficacy, the drug is not approved. There must be strict objective evidence of both safety and efficacy. It must also be objectively clear that the benefits outweigh the risks before a new drug is approved. It can only be objectively clear that the benefits of a drug outweigh the risks when the benefits and risks are objectively known. The test for Covid-19 vaccines abandoned this need for objective certainty. Instead of requiring objective proof of: safety; efficacy, and benefit outweighing risk. The Covid-19 vaccines were authorized under a subjective test which mandated that authorization must be granted if an argument could be made to support the conclusion that the benefits outweighed the risk. The question arises: what if there was evidence that went both ways? In other words, what if there was evidence that pointed towards greater benefits, but there was also evidence that pointed towards risks? Under the Interim Order, it seems the Minister must then take into account the subjective factors of: uncertainty and the urgent public health need for a vaccine. This cannot be an appropriate standard for approving a drug that the Government intends to administer to the entire population. It is difficult to conceive of a less-scientific test for drug authorization than that found in the Interim Order. The Interim Order also ensured that the authorization of a Covid-19 vaccine could not be revoked: due to evidence the vaccine was unsafe or not-effective; due to assessments the benefits did not outweigh the risks. This resulted from the fact that once a vaccine was authorized under the Interim Order, most of the Regulations did not apply, including C.08.006. This particular regulation is the safeguard that allows the Minister of Health to cancel a drug’s market authorization if evidence is uncovered that the drug is not safe. Instead, the Interim Order contained its own vague safeguards allowing for cancellation only in a few limited circumstances. The exclusion of the Minister’s normal powers to revoke authorization, and the reliance on more restricted revocation powers under the Interim Order means that Canadians could not have confidence that the Covid-19 vaccines would be pulled from the market if there was evidence that they were not safe. This situation persisted for roughly a year. Were the Covid-19 Vaccines Approved Without Safety or Efficacy Proof? In addition to the Interim Order, Health Canada created a document called "Guidance for market authorization requirements for Covid-19 vaccines." This document is intended to provide guidance to pharmaceutical companies applying for market authorization. As it must, it follows the new subjective test for the vaccines. For example, the current version includes: About market authorizations for a Covid-19 vaccine Health Canada will grant authorizations only if we determine that the benefits of the vaccine outweigh its potential risks. We will base our decision on the evidence provided on the vaccine's safety, quality and efficacy. For vaccines relying on the modified requirements in C.08.002 (2.1) of the Food and Drug Regulations, the risk- benefit analysis weighs the uncertainties about a potential vaccine against the public health need for a vaccine at the time of the decision. Modified requirements for Covid-19 drugs make it possible for initial authorization, based on early data, while the manufacturer continues working on developing a vaccine. We will use terms and conditions to manage uncertainties or risk mitigation measures related to the vaccine in the context of public health. The NCI heard testimony that the Health Canada employee who authorized all of the Covid-19 vaccines swore an Affidavit for a lawsuit for Federal Court File No. T-145-22 in which she described the basis of Health Canada's authorization of the Pfizer/ BioNTech and Moderna vaccines. Instead of setting out the evidence relied on in support of the authorization, she simply parrots the words of the test. In the case of Pfizer/ BioNTech, she stated that Health Canada reviewed "quality (chemistry and manufacturing), non-clinical (pharmacology and toxicology), and clinical (immunogenicity, safety, and efficacy) information" and then concluded that "the evidence supports the conclusion that the benefits associated with the Pfizer.BioNTech COVID.19 Vaccine outweigh the risks, having regard to a shorter term (median of 2 months) follow up of safety and efficacy at authorization, and the necessity of addressing the urgent public need related to COVID.19." In the case of Moderna, she stated similarly that: "the evidence supported the conclusion that the benefits associated with the Moderna COVID.19 Vaccine outweighed the risks, having regard to a shorter term (median of 2 months) follow up of safety and efficacy at authorization, and the necessity of addressing the urgent public health need related to COVID.19." Notably, what she does not cite in support of the vaccine authorization is: objective proof of safety; objective proof of efficacy, and objective proof that the benefits outweigh the risks. Based on testimony to the NCI, and without further evidence from Health Canada, we cannot conclude that Health Canada properly evaluated the safety and efficacy of the Covid-19 vaccines before authorization. To the contrary, the authorization of the vaccines appears to have been all but pre-assured by the creation of the Interim Order. The Interim Order Has Become Permanent The Interim Order can only last for a maximum of one year. The Interim Order, therefore, was replaced on March 18, 2021, with permanent regulations that codify the subjective authorization test discussed above. The only notable change between the test in the Interim Order and the new permanent regulation is that the "public health need" that needs to be addressed is no longer described as urgent. Recall that the Interim Order required an examination of risks and benefits, while: “having regard to “the necessity of addressing the urgent public health need related to Covid-19" Now the test simply requires Health Canada to give consideration to “the public health need related to Covid-19.” Thus, under the permanent test, Health Canada no longer has to be swayed by urgency, but simply by the public health need related to Covid-19. In this way, it seems that so long as Covid-19 is a circulating virus, Health Canada must authorize any vaccine for which there is an argument to support the conclusion that its benefits outweigh its risks. In effect, we fear that there will never be a need for Covid-19 vaccine manufacturers to prove safety or efficacy of their products. On a positive note, the NCI heard that the Minister's ability to revoke authorization of Covid-19 vaccines is now subject to the same regular rules as other drugs that are approved for the market. It does beg the question, however, of why was that particular rule modified for Covid-19 vaccines in the first place? Conflict of Interests for the Approval of Experimental Vaccines Canada normally prohibits drugs from being imported into Canada unless they have been approved by Health Canada for use in humans. Despite this, the Interim Order allowed unapproved and unauthorized Covid-19 vaccines to be imported into Canada as long as the Canadian Government was the purchaser. This was called pre-positioning in the Interim Order, and later in the Regulations codifying the Interim Order. The rationale was to assist Canada in expediting its response to the perceived Covid-19 crisis, by pre-purchasing and distributing the vaccines so they would be ready as soon as they were authorized. However, this created a tremendous conflict of interest. Once the vaccines were purchased, imported and ready for distribution, the Government of Canada would have suffered significant political blowback if it was unable to authorize them. Thus, it needed to authorize the Covid-19 vaccines, and it needed to do it quickly. The Government of Canada essentially put itself in charge of authorizing a drug that it had spent millions of public dollars on, had promised publicly on many occasions, and that it wanted to administer to every Canadian citizen. The authorization of the Covid-19 vaccines was all but guaranteed. The Government of Canada ordered the vaccines, imported them, created new regulations to authorize them, and then took significant measures to convince and coerce every Canadian to take multiple doses. The political stakes were high, and the federal government had every motivation to get the vaccines authorized, regardless of their actual efficacy or safety. There was no opportunity for sober second thought. There was no impartial oversight. The entire authorization process appears to have been "gamed" for one result, and one result only: authorization of vaccines for every Canadian, including children. Once the federal Government made mass-vaccination its priority, it should no longer have been solely responsible for their authorization. Timing of the Interim Order The timing of the Interim Order is also curious and coincident. Notably, the September 16, 2020 Interim Order was created just two weeks before AstraZeneca's authorization application was filed with Health Canada, and just three weeks before Pfizer filed on October 8, 2020. Since the authorization applications were made under the Interim Order, they would have been structured to meet the requirements of the Interim Order. Perhaps an authorization application is a standard document, however, the NCI suspects that it would be difficult for a company to prepare a detailed authorization application without knowing what the authorization requirements were going to be. For this reason, there are further questions that need to be answered about how the applications could have been filed so quickly in a manner that satisfied the subjective test, and whether there was participation in creating, or knowledge of the contents of, the test in advance. Phase Three Trial Data Alleged Manipulation of Data Deana McLeod Insights into Covid Vaccine Approval and Trials Deana McLeod's testimony has raised important concerns about the means and methods used in testing Covid-19 vaccines. Her testimony primarily centred on potential conflicts of interest and biases within the teams responsible for conducting and reporting Phase Three test data, which was submitted to Health Canada. Additionally, McLeod shed light on Pfizer's historical legal issues and the broader issue of potential conflicts of interest within the regulatory and approval sector. Her testimony echoed Mr. Shawn Buckley's prior statement that objective tests demonstrating safety and efficacy were omitted from these products. Financial incentives at various stages of the testing and authorization process were also discussed, prompting the need for a thorough examination of motivations. McLeod's testimony serves as a reminder of the importance of transparency, objectivity, and independence in the testing and approval of medical products, especially when it concerns a global health crisis. The potential for conflicts of interest and biases within such a critical process can erode public trust and compromise the credibility of the regulatory framework. The reference to Pfizer's past legal issues underscores the necessity for scrutinizing the track record of pharmaceutical companies involved in the development of vaccines or drugs. The public has a right to be informed about any potential historical shortcomings or ethical concerns that might impact the reliability of the products in question. The removal of objective safety and efficacy tests from the products raises alarming questions about the standards applied to these vaccines. Rigorous testing is the cornerstone of any vaccine's credibility and the foundation of public trust. Omitting such tests potentially undermines the credibility of the entire testing and approval process. The mention of financial motivations at various levels of testing and approval emphasizes the need for greater transparency and accountability within the industry. The potential for financial incentives to influence decision-making is a cause for concern and demands further investigation to ensure that public health is prioritized over financial gain. Lastly, the allusion to Statistics Canada data provided during the testimony highlights the need for comprehensive, reliable, and complete data when assessing the impact of any medical intervention. It is crucial to base decisions on thorough and unbiased information to ensure the well-being of the population. In conclusion, Deana McLeod's testimony raises vital questions about the processes, motivations, and ethics involved in Covid-19 vaccine testing and authorization. This testimony underscores the necessity for transparent, objective, and unbiased approaches in these critical endeavours. The concerns raised must prompt a broader discussion about regulatory practices, industry accountability, and the integrity of medical interventions in the interest of public health and safety. Conclusions There appeared to be a disconnect between Health Canada messaging concerning vaccine approval and the actual test used for authorization. As indicated above, safety, efficacy and whether the benefits of the vaccines outweighed the risks did not need to be proven under the Interim Authorization process employed by Health Canada. Despite the novel nature of the vaccines – in particular those using mRNA – the pharmaceutical companies did not have to objectively prove their safety and efficacy. It should be noted that the special authorization process created under the Interim Order was not mandatory, and pharmaceutical companies still had the option to apply for approval under the regular test which required objective proof of safety, efficacy and cost/ benefit. The pharmaceutical companies did not choose to objectively prove safety, efficacy and cost/benefit. They chose to apply under the Interim Order test, and regulators did not require it of them. Of great concern is the disconnect between Health Canada's public messaging about the Covid-19 vaccines as safe and effective when the regulatory authorization process clearly does not require these be objectively demonstrated. Health Canada continues to message to the public that the regular drug approval requirements of safety and efficacy were met. For example, at the top of Health Canada’s website page for the Pfizer vaccine, Health Canada states: All Covid-19 vaccines authorized in Canada are proven safe, effective and of high quality [emphasis in the original]. Recommendations Newly implemented revisions to the Food and Drug Regulations related to the authorization of Covid-19 vaccines must be rescinded as they permanently exempt Covid-19 vaccines from the requirements to objectively prove the Safety or Efficacy as required under the Food and Drug Regulations. The current use of Covid-19 vaccines in Canada that were authorized under the revised provisions of the Interim Order and the newly revised Food and Drug Regulations, should be stopped immediately. A full judicial investigation of the process under which the Covid-19 vaccinations were authorized in Canada must be carried out. Criminal liability, if discovered, may be dealt with under existing Canadian law. All documentation concerning the authorization process and information provided to the regulatory agencies by the manufacturers should be made publicly available. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
- NCI-R-02-Item-7-5 | National Citizens Ar
7.5 HEALTH 7.5 Health Introduction This section of the report is based on the testimony of more than 60 expert witnesses and dozens of citizens who have struggled with many health issues caused by health measures ranging from lockdowns, mask mandates, and vaccine mandates. Emerging, from an overall assessment of the bulk of the testimonies, is a trend describing the evolution of most of the witnesses, at varying pace, of their respective understanding of this very complex and confusing COVID-19 pandemic health crisis. Whether it was expert witnesses or regular citizens, many were unaware of what was unfolding gradually, then suddenly, they came to appreciate that something odd was going on. These informed individuals are still a fringe, yet there is a rapidly growing minority that are relentlessly sharing their understanding of the bizarre health crisis that we experienced. Because of their habitual trust in the institutions, very few had detected the actual situation earlier on: the absurdity of the proposed non-pharmaceutical interventions (NPIs) along with the suppression of early treatment on baseless grounds. Consensus grew with hundreds of thousands of people acknowledging in hindsight the absurdity of the pandemic management. Measures enacted by the government had massive collateral damage and hardly any demonstrated benefits. These measures were supported and presented to the public by a very powerful propaganda campaign. However, to this day, the majority of the population still believe that the NPIs were effective and vaccination was the only way out of the pandemic. Disseminating the truth to the public will be a challenging endeavour. Unless individuals are willing to question the fundamental objectives of what the pandemic truly entailed and the reasoning behind altering established pandemic management plans to embark on an unprecedented and massive social engineering experiment, they will struggle to recognize the disastrous outcomes resulting from the mishandling of this crisis. Only by addressing these issues can we initiate the essential process of rectification. List of Witnesses In preparing this commentary, the authors relied on the following list of witnesses: Lt. Col. David Redman An expert on emergency preparedness, he testified on Canada‘s deviation from strategic pandemic response. (Red Deer: April 27, 2023) Dean Beaudry He spoke about risk management and COVID-19 policies. (Red Deer: April 26, 2023) David Leis An expert on public policy, he gave testimony on public policy during the pandemic. (Winnipeg: April 15, 2023) Dr. Natalie Björklund-Gordon An expert in epidemiology and genetics, she revealed flaws in the COVID response. (Winnipeg: April 14, 2023) Michel Chossudovsky An economics professor and director of the Centre for Research on Globalization, he reviewed the social and economic global collapse. (Québec City: May 13, 2023) James Corbett An investigative reporter, he unveiled the global pandemic treaty and WHO‘s expanding authority. (Ottawa: May 18, 2023) Dr. Jérôme Sainton A medical doctor, he analyzed the risk–benefit of vaccines. (Québec City: May 13, 2023) Christian Leray A media specialist, he denounced the lack of transparency during COVID-19 pandemic. (Québec City: May 11, 2023) Dr. Jeff Wilson A PhD in public health, he discussed the proper outbreak response. (Ottawa: May 19, 2023) Louise MacDonald She broke down the misleading government data on vaccine statistics. (Ottawa: May 17, 2023) Dr. Stephen Malthouse He gave a physician‘s perspective to challenging COVID policies. (Ottawa: May 17, 2023) Dr. Robert Malone An expert in mRNA technology, he spoke about 5th-generation warfare. (Toronto: March 30, 2023) Dr. Steven Pelech He discussed the science behind viruses and mRNA vaccines. (Vancouver: May 3, 2023) William Munroe A population analyst, he provided insight into COVID death statistics. (Vancouver: May 2, 2023) Dr. Jonathan J. Couey A neurobiologist, he gave a presentation on coronavirus, PCR testing, and pathogenesis. (Red Deer: April 28, 2023) Dr. Keren Epstein-Gilboa An expert in developmental psychology, she gave a presentation on the impacts of the COVID measures on children. (Ottawa: May 18, 2023) Prof. Douglas Allen An economics professor, he analyzed lockdown measures from a risk–benefit perspective. (Vancouver: May 4, 2023) Dr. Greg Passey An expert in post-traumatic stress disorder, he spoke about narrative shaping and psychological damage from lockdowns. (Vancouver: May 3, 2023) Dr. Matthew Cockle He discussed the conflicts of interest in global health research funding organizations. (Vancouver: May 2, 2023) Joseph Bourgault He spoke on concerning CO2 levels in paper masks. (Saskatoon: April 20, 2023) Irvin Studin He spoke on the impact of school closures on children‘s education. (Toronto: April 1, 2023) Lynette Tremblay She shared her heart-wrenching experience during lockdowns. (Québec City: April 12, 2023) Navid Sadikali An expert in medical imaging, he explored pandemic rationale and the limitations of COVID injections. (Ottawa: May 19, 2023) Dr. David Speicher He highlighted issues with PCR testing and COVID data. (Ottawa: May 18, 2023) Madison Peake She gave a personal account of the lockdowns‘ psychological toll. (Ottawa: Day May 17, 2023) Kim Hunter She discussed the detrimental effects of masking on children. (Vancouver: May 3, 2023) Ryan Orydzuk He discussed occupational health and safety considerations. (Saskatoon: April 21, 2023) James Lunney He explored the vital role of vitamin D for optimum health. (Ottawa: May 19, 2023) Dr. Francis Christian He testified on the censorship of physicians, such as he and Dr. Paul Marik. (Saskatoon: April 20, 2023) Alan Cassels He spoke about the UBC therapeutics initiative and provided a critical pharmaceutical analysis. (Vancouver: May 2, 2023) Bryan Baraniski He spoke about alternative medication. (Saskatoon: April 20, 2023) Charles Hooper He discussed the facts and fiction of ivermectin. (Winnipeg: April 14, 2023) Dr. Barry Bregar He discussed the unnecessary fear, suppressed treatments, and vaccine dangers. (Québec City: May 12, 2023) Dr. Daniel Nagase He discussed the unjust treatment of patients and doctors during COVID. (Ottawa May 19, 2023) Melanie Alexander She shared the story of her husband‘s medical mistreatment during COVID. (Ottawa: May 19, 2023) Dr. Edward Leyton He spoke of the influence of medical regulatory boards and ivermectin therapy. (Ottawa: May 18, 2023) Dr. Peter McCullough He discussed a study into the autopsy results of vaccine injury deaths. (NCI Virtual Testimony: July 19, 2023) Dr. Justin Chin He unveiled the truth regarding adverse reactions and the vaccine rollout. (Red Deer: April 27, 2023) Prof. Denis Rancourt He presented findings on all-cause excess deaths in Canada during the pandemic. (NCI Virtual Testimony: June 28, 2023) Prof. Patrick Provost An infectious disease specialist, he spoke about concerns with mRNA technology. (Québec City: May 13, 2023) Prof. Christian Linard He discussed concerns about the potential risks and adverse effects of the mRNA vaccine, including its long-term impact on human health. (Québec City: May 11, 2023) Vincent Cantin He testified about his severe vaccine injury. (Québec City: May 13, 2023) Dr. René Lavigueur A family doctor, he shared his expert perspective on COVID-19 vaccine side effects. (Québec City: May 12, 2023) Dr. Sabine Hazan A microbiome expert, she testified about effective therapies for COVID-19. (Québec City: May 12, 2023) Évelyne Therrien She testified about her severe vaccine injury. (Québec City: May 12, 2023) Christine Cotton She revealed flaws in Pfizer‘s clinical trials. (Québec City: May 12, 2023) Dr. Hélène Banoun She discussed mRNA vaccines and their side effects. (Québec City: May 12, 2023) Carole Avoine She testified about her severe vaccine injury. (Québec City: May 12, 2023) olleen Brandse She testified about her severe vaccine injury. (Toronto: April 1, 2023) Prof. Denis Rancourt He presented findings regarding excess deaths during COVID pandemic. (Québec City: May 11, 2023) Caroline Foucault She testified about her severe vaccine injury. (Québec City: May 11, 2023) Josée Belleville She was a victim of vaccination obligations and discrimination in the army. (Québec City: May 11, 2023) Prof. Christian Perronne He spoke on attacks, WHO infiltration, and the dangers of the COVID-19 injection. (Québec City: May 11, 2023) Prof. Jean-Marc Sabatier He testified about the COVID virus and vaccine triggers. (Québec City: May 11, 2023) Pierre Chaillot He testified on the misuse of statistics during COVID-19. (Québec City: May 11, 2023) Prof. Didier Raoult He testified on the evolution of the COVID virus, treatments, and the vaccine. (Québec City: May 11, 2023) Mélissa Sansfaçon She testified about her severe vaccine injury. (Québec City: May 11, 2023) Scarlett Martyn A paramedic, she spoke about the impact of vaccine mandates. (Toronto: April 1, 2023) Kimberly Warren She testified about her vaccine injury and severe kidney problems. (Ottawa: May 19, 2023) Aidan Coulter He testified about his personal experiences as an unvaccinated student. (Ottawa: May 19, 2023) Pascal Najadi He discussed the global implications regarding Swiss authorities and the enforcement of COVID vaccines. (Ottawa: May 19, 2023) Dr. Chris Shoemaker He unveiled the risks and dangers of the COVID-19 vaccine. (Ottawa: May 19, 2023) Maurice Gatien He provided historical context for what‘s happening and his work defending the vaccine injured. (Ottawa: May 18, 2023) Laurier Mantil A letter carrier, she discussed balancing pregnancy and safety. (Ottawa: May 18, 2023) Capt. Scott Routly He gave a pilot‘s perspective on navigating vaccine mandates. (Ottawa: May 18, 2023) Jean-Philippe Chabot A former CBC employee, he gave insights into navigating his vaccine status disclosure. (Ottawa: May 18, 2023) Samantha Monaghan She testified on the tragic loss of her son after a blood transfusion. (Ottawa: May 18, 2023) M Tisir Otahbachi He shared his story of vaccine injury and what followed in the healthcare system. (Ottawa: May 17, 2023) Mallory Flank A former paramedic, she shared her devastating vaccine injury story. (Ottawa: May 17, 2023) Sheila Lewis She gave her heartbreaking story of her life-saving transplant being withdrawn. (Ottawa: May 17, 2023) Camille Mitchell A pharmacist, she testified on vaccine mandates in healthcare. (Vancouver: May 4, 2023) Shawn Mulldoon He testified about his severe vaccine injury. (Vancouver: May 4, 2023) Paul Hollyoak A coast guard rescue specialist, he testified about his severe vaccine injury. (Vancouver: May 4, 2023) Wayne Llewellyn He testified about his struggles against vaccine mandates. (Vancouver: May 4, 2023) Zoran Boskovic He shared his experience of losing his job due to vaccine mandates. (Vancouver: May 4, 2023) Ted Kuntz He testified on Canada‘s lack of safety, efficacy, and Informed Consent for childhood vaccines. (Vancouver: May 4, 2023) Kristen Ditzel She testified about her severe vaccine injury. (Vancouver: May 4, 2023) Patricia Leidl She testified about her severe vaccine injury. (Vancouver: May 4, 2023) Dr. Ben Sutherland He discussed the consequences of vaccine mandates. (Vancouver: May 3, 2023) Lisa Bernard She testified on vaccine injury and the impact of lockdowns on patient care and mental health. (Vancouver: May 3, 2023) Dr. Charles Hoffe He testified on natural immunity and COVID vaccine health issues. (Vancouver: May 3, 2023) James Jones He spoke about the tragic consequences of the vaccine mandates and workplace bullying. (Vancouver: May 3, 2023) Edward Dowd He discussed the alarming data behind increased death and disabilities. (Vancouver: May 3, 2023) Dr. Chris Shaw A neuroscientist, he discussed his insights into the future of the vaccinated. (Vancouver: May 2, 2023) Deanna McLeod She testified about the COVID vaccine approval and trials. (Vancouver: May 2, 2023) Serena Steven A former nurse, she testified on vaccine-related injuries. (Vancouver: May 2, 2023) Philip Davidson A public service employee, he discussed job loss due to vaccine mandate. (Vancouver: May 2, 2023) Vanessa Rocchio She testified regarding COVID-19 genetic vaccine injury and cardiac damage. (Vancouver: May 2, 2023) Jennifer Curry She testified about her severe vaccine injury. (Red Deer: April 28, 2023) Dr. Eric Payne A pediatrician, he testified on the dangers of COVID-19 vaccines for children. (Red Deer: May 28, 2023) Dr. Misha Susoeff A dentist, he discussed third-party Informed Consent. (Red Deer: May 28, 2023) Judy Soroka She spoke of struggles with the vaccine mandate and medical treatment. (Red Deer: April 26, 2023) Dr. Gregory Chan He spoke of his experience in healthcare during the COVID-19 genetic vaccine rollout. (Red Deer: April 26, 2023) Dr. Christopher Flowers He testified regarding the clinical trial data reported by Pfizer. (Saskatoon: April 22, 2023) Dr. Maria Gutschi She gave a presentation as a pharmacist and regulatory specialist. (Saskatoon: April 21, 2023) Steve Kirsch He placed bets on “The Science” and discussed the statistics on vaccine data. (Saskatoon: May 20, 2023) Deanna McLeod She testified about vaccine development and the changes to health safety regulations. (Winnipeg: April 13, 2023) Michael MacIver An embalmer, he spoke about funeral industry abnormalities. (Winnipeg: April 13, 2023) Dr. Jay Bhattacharya He spoke on the principles of the Great Barrington Declaration. (Winnipeg: April 13, 2023) Dr. Jessica Rose She gave an in-depth presentation about VAERS data on COVID-19 vaccines. (Winnipeg: April 13, 2023) Dr. Joseph Fraiman He shared his experience in the USA during COVID 2020. (Truro: March 17, 2023) Dr. Mark Trozzi An ER physician, he gave a powerful testimony on mRNA vaccines. (Toronto: April 1, 2023) Laura Jeffery A licensed funeral director, she spoke about post-vaccine embalming. (Toronto: March 31, 2023) Dr. Laura Braden She addressed the natural origin of COVID and mRNA vaccines. (Truro: March 18, 2023) Dr. Patrick Phillips A medical doctor, he had his medical licence suspended by the College of Physicians and Surgeons of Ontario (as of May 2022 in relation to his communications on social media) (Truro: March 16, 2023) Dr. William Makis An oncologist, he spoke about vaccine mandates and Informed Consent. (NCI Virtual Testimony: September 18, 2023) Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
- NCI-R-04-Item-4-7-1 | National Citizens Ar
4.7.1 mRNA Vaccines, Public Health, and Safety Concerns 4.7 mRNA Vaccines, Public Health, and Safety Concerns 4.7.1 Reference to the Original NCI Report The original NCI report titled Inquiry into the Appropriateness and Efficacy of the COVID-19 Response in Canada (November 28, 2023) examined vaccine safety as a critical element of its findings. The testimonies of Dr. Byram Bridle, Dr. Paul Thomas, and Dr. Jessica Rose during the NCI Vancouver Hearings expand on these concerns, with a focus on mRNA vaccine technology, its safety, and broader public health implications. Introduction The development and roll-out of mRNA vaccines during the COVID-19 event marked a significant milestone in vaccine technology. However, the rapid adoption of this new platform also introduced a range of safety, regulatory, and public health challenges. The Vancouver NCI hearings provided a platform for expert witnesses to critically evaluate the risks associated with mRNA vaccines, focusing on their safety, efficacy, and the broader implications for public health. Their testimonies highlighted the need for a thorough reassessment of the oversight and implementation of mRNA vaccine programs in Canada. Witnesses, including Dr. Byram Bridle, Dr. Paul Thomas, and Dr. Jessica Rose, raised critical concerns about the safety of mRNA vaccines, particularly for vulnerable populations such as children, pregnant women, and individuals with pre-existing health conditions. Central themes of their testimonies included inadequate safety testing, regulatory failures, and alarming trends in adverse event reporting. They also emphasized systemic issues related to the transparency and accountability of public health institutions, pointing to significant gaps in how mRNA vaccines are assessed and monitored. A major area of focus was the safety of mRNA vaccine components, such as lipid nanoparticles (LNPs) and aluminum adjuvants, which are integral to the vaccine's delivery and efficacy. Witnesses warned about the potential bio-distribution and persistence of these components in the body, raising concerns about their impact on vital organs, including the brain, liver, and reproductive system. Compounding these concerns were findings of DNA contamination, in vaccine vials, which included SV40 fragments, known to promote cancer, that exceeded established safety thresholds. The testimonies also brought attention to troubling trends in adverse event reporting. Data from the Vaccine Adverse Event Reporting System (VAERS) revealed a dramatic surge in reported adverse events following the introduction of mRNA vaccines. Witnesses pointed to inconsistencies in safety monitoring and quality control, which undermined confidence in the safety of these vaccines. Regulatory agencies’ reliance on manufacturer supplied data, without adequate external oversight, was identified as a critical flaw in the system. The hearings underscored the need for a more cautious and evidence-based approach to mRNA vaccine policies, particularly for children and pregnant women. Witnesses advocated for independent oversight, enhanced safety testing, and improved regulatory accountability, plus an outright moratorium on their use in all populations. They also highlighted the broader public health implications of eroding trust in vaccination programs, which could have lasting consequences for future public health initiatives. This section synthesizes the testimonies presented during the NCI Vancouver Hearings, offering a comprehensive examination of the risks associated with mRNA vaccines and the systemic challenges in their oversight. By addressing these issues, the findings presented in this section aim to support meaningful reforms that prioritize public safety, rebuild trust, and ensure the transparency and accountability of vaccination programs in Canada. Discussion of Witness Testimonies Dr. Byram Bridle Overview of Testimony Dr Bridle is a widely published expert in the fields of immunology, Virology and Vaccinology and has conducted extensive grant-funded research into vaccines, including for COVID-19. His review of the preclinical and clinical research data concerning the mRNA vaccines developed for COVID-19 led him to very serious concerns about the validity of the data on effectiveness and safety. As a result of expressing those concerns, he has suffered significant damage to his career and professional reputation. His concerns are summarized below. Pfizer COVID-19 Vaccine structure safety concerns The vaccine is composed of Lipid Nanoparticles (LNPs) within which viral mRNA coding for the viral spike protein (S protein) is enclosed. This technology enables insertion of the mRNA into mammalian cells which then coerces the cell’s own protein synthesis mechanisms to produce spike protein which is subsequently expressed on the cell surface. Polyethylene Glycol (PEG) is also included in the vaccine to enhance systemic bio-distribution. LNPs are toxic and may cause anaphylaxis, especially following repeated exposure, as occurs with repeated vaccine boosters. The spike protein produced following vaccination is itself a noxious substance especially when forming complexes with S protein antibodies and is responsible for many of the clinical features of COVID-19 infection. There is also evidence that ‘misreading’ of the vaccine mRNA may produce variant S proteins whose effects are unpredictable. The vaccines have also been shown to contaminated with viral DNA though the possible consequences of this have not been adequately researched. The most recent iteration of the vaccine technology has added an enzyme which promotes replication of the delivered mRNA and this has now entered clinical use in Japan. Bio-distribution Concerns Although the public were informed that “the vaccine stays at the injection site” the initial rodent studies done by Pfizer show that this is not the case. Only approximately 20% of the vaccine components stay at the injection site. The remainder is widely distributed in many tissues and organs, including the kidneys and adrenals, lungs and skin. The LNPs readily pass the blood-brain barrier and spike protein (S protein) has been demonstrated in the brain. A further concern is that the data from the initial studies presented to the regulatory bodies in Japan and the Food and Drug Administration in the USA were manipulated in a way that minimized evidence of widespread distribution of the vaccine components. This manipulation included cropping of images of test animals to exclude evidence of vaccine components concentrated away from the injection site. Many peer-reviewed studies are now available confirming the wide distribution of the vaccine components in human tissues and organs. Bio-persistence Concerns The FDA said that studies in animals showed the vaccine ingredients returned to normal levels in the body after 9 days. But the actual data tells a different story. While the levels did go down, they hadn’t fully returned to normal by day 9. Also, the data combined results from both male and female animals. When researchers looked at males and females separately, they found something important: in male animals, the vaccine ingredients were decreasing (though still not quite back to normal), but in female animals, the levels were still going up in almost every organ all the way to the end of the study. Peer-reviewed studies are now available which show persistence of S protein in widespread tissues for many months and sometimes at alarmingly high concentrations. Clinical Data in Humans Pfizer’s own initial published statements say that the vaccine is indicated to prevent COVID-19 infection. This has subsequently been altered to state that “The vaccine may contribute to protection against COVID-19.” Pfizer has not made any claims that the vaccine could reduce the severity of infections, though public health authorities have publicly made that claim. The first clinical trials were conducted in young healthy volunteers and did show a “small but statistically significant protective effect against infection.” This group however is at minimal risk from COVID-19 and the trial results do not necessarily imply effectiveness in a roll-out to the general population. Pfizer itself has acknowledged a higher reporting of 7.3% fatal outcomes in vaccinated frail, elderly patients compared to the general population. Data from the Ministry of Health in British Columbia comparing patients given the COVID-19 vaccine versus historical data for the influenza vaccine show that adverse events were 11 times higher following COVID-19 vaccination, severe adverse events were 16 times higher, hospitalizations were 14 times higher and deaths were 28 times higher per dose . Concerns About Pregnant and Lactating Women In response to a question tabled in the Canadian Parliament by the Member for Yorkton-Melville asking “What is Health Canada’s scientific basis for claiming safety of the vaccine in pregnant and lactating women?”, Health Canada eventually responded that it “had not approved any safety claims with respect to pregnant and lactating women.” Pfizer’s own product monograph also states clearly that “safety has not been established in pregnant and lactating women.” Despite this, Federal and Provincial officials, including the Ontario Minister of Health, have continued to claim otherwise and encouraged vaccine usage in this patient group. Before authorization was granted for use of the COVID-19 vaccine in pregnant and lactating women, a number of such patients were treated (some did not know they were pregnant and some were treated erroneously). A study of this group has shown that 25% of the mothers and 25% of children reported side-effects from the vaccine, and 50% of the reported side effects were “severe.” Data from the BC Ministry of Health show that serious side-effects in women following COVID-19 vaccination were 18 times higher than those following influenza vaccinations. Concerns About “Shedding” Following vaccination, viral mRNA or mRNA fragments have been shown to occur in breast milk, faeces and urine. There is increasing evidence that shedding may also occur from skin and saliva and possibly respiratory droplets. The clinical significance of this is unclear and more research needs to done urgently to identify any harms. There is also concern that the new technology of self replicating mRNA vaccines may lead to increased levels and persistence of shedding. Dr Bridle’s Conclusions mRNA injections should be completely suspended in the light of the available data. Incorrect information and advice about the COVID-19 vaccines produced by health authorities means that true informed consent is not possible. Given the experience with COVID-19 injection policies, it is likely that the data supporting the authorization of a wide range of other vaccines should be carefully reviewed. The health consequences of mRNA vaccines may be chronic and increase over time and this will require diligent monitoring. Key Points from Testimony: Bio-distribution Issues: Contrary to claims that vaccine components remain localized at the injection site, Pfizer’s preclinical studies revealed that only 20% stayed at the injection site, while 80% distributed across various organs, including the brain, liver, and reproductive organs. Bio-persistence: Vaccine components persisted far longer in the body than the nine day baseline initially reported. Differences in male and female metabolism further complicate the understanding of vaccine safety. Adverse Events Data: Data from British Columbia indicated that adverse event rates following COVID-19 vaccination were up to 28 times higher than those for influenza vaccines. Safety for Pregnant Women: Despite limited safety data for pregnant and lactating women, mRNA vaccines were widely recommended for this group, leading to reports of elevated adverse outcomes. Dr. Paul Thomas Overview of Testimony Dr. Paul Thomas, a Board Certified Paediatrician and Addiction Medicine Specialist, testified about the health outcomes associated with vaccination practices. His “vaccine friendly" approach allowed parents to adopt modified schedules, and his research examined differences in health outcomes between vaccinated and unvaccinated children. He later came to the collusion that he could not recommend any vaccines for children. Key Points from Testimony: Health Outcomes Study: Dr. Thomas’s peer reviewed research found lower rates of asthma, ADHD, and behavioural issues in unvaccinated children compared to vaccinated counterparts. Aluminum Adjuvants: He criticized the presence of aluminum in vaccines, highlighting that doses often exceeded FDA safety limits for infants. Correlation with SIDS: Dr. Thomas referenced peer-reviewed studies indicating that 97% of Sudden Infant Death Syndrome (SIDS) cases occurred within 10 days of vaccination. Adverse Event Data: VAERS data showed an exponential increase in reported adverse events following the introduction of COVID-19 vaccines, with higher rates of hospitalizations and deaths. Dr. Jessica Rose Overview of Testimony Dr. Jessica Rose, a computational biologist with expertise in vaccine adverse event analysis, presented detailed insights into systemic flaws in the reporting and oversight of mRNA vaccine safety. Key Points from Testimony: DNA Contamination in Vaccine Vials: Testing revealed DNA contamination exceeding WHO standards, including the presence of SV40 fragments, a known cancer-promoting agent. VAERS Trends: Annual adverse event reports surged from 39,000 pre-COVID to over 750,000 in the first year of the mRNA vaccine roll-out. Deaths per 1,000,000 doses were 70 times higher for COVID-19 injections compared to influenza vaccines. Risks to Children: VAERS data for children aged 0-17 showed disproportionately high rates of adverse events, particularly in the 12-17 age group. Priya Sall Overview of Testimony Priya Sall testified about her experience as a vaccine-injured young person, discussing the health challenges she faced after receiving COVID-19 vaccinations. Her testimony focused on the physical toll, the medical response she received, and her call for other young people to come forward with similar experiences. Key Points Pre-Vaccine Health and Disability: Sall was born prematurely at 25 weeks, weighing only two pounds. Due to her premature birth, she was diagnosed with cerebral palsy (level three) and a vision impairment. She used a walker for mobility outside her home but was able to walk indoors independently. These conditions existed prior to receiving the COVID-19 vaccine. Health Complications Following Vaccination: Sall reported experiencing severe adverse effects following the COVID-19 vaccine, including seizures. Her father called emergency services after her third seizure, and she was taken to the hospital. While in the hospital, she underwent blood work and basic medical assessments, but she was not admitted for extended care. She was told she would receive an EEG to investigate potential neurological damage, but it took three months before she was able to get the necessary medical equipment for testing. Call for Awareness and Advocacy: Sall encouraged other young people who believe they were injured by vaccines to come forward and share their stories. She warned parents and young individuals to be skeptical of mainstream news narratives, arguing that misinformation could have life-threatening consequences. She cited the case of Sean Hartman, a 16-year old who allegedly died after receiving a COVID-19 vaccine in order to play hockey, using his story as a cautionary example. She expressed support for legal actions against pharmaceutical companies and government agencies, hoping that lawsuits would set a precedent for accountability. Priya Sall’s testimony highlights the challenges faced by individuals who report vaccine injuries, particularly in accessing medical care and recognition. Her case underscores concerns about medical responsiveness, long wait times for neurological assessments, and the emotional and physical toll of adverse effects. She positioned her experience within a broader call for advocacy, urging others to come forward and pushing for legal and systemic accountability. Discussion and Analysis of Issues Raised by the Witnesses Challenges in Ensuring Vaccine Safety The testimonies of Dr. Byram Bridle, Dr. Paul Thomas, and Dr. Jessica Rose collectively raised significant concerns about the safety and oversight of mRNA vaccines. Dr. Bridle’s testimony on bio-distribution and bio-persistence issues challenged initial assurances about the localized nature of vaccine components, suggesting that their systemic spread could have long-term health implications. This lack of clear and transparent data about the distribution of vaccine components underscores a critical gap in regulatory oversight, particularly as it relates to vulnerable populations such as pregnant women. Dr. Thomas reinforced these concerns by highlighting systemic weaknesses in vaccine testing and safety standards, including the use of aluminum adjuvants that exceed safety thresholds for infants. His findings also linked vaccination policies to increased risks of chronic illnesses and adverse reactions, emphasizing the need for rigorous pre-approval testing and continuous post-marketing surveillance. Dr. Rose’s analysis of VAERS data pointed to a sharp increase in adverse event reporting following the introduction of COVID-19 vaccines. The presence of DNA contamination in vaccine vials raised additional red flags about the manufacturing and quality control processes. The testimony of all three experts underscores a failure to ensure vaccine safety through adequate testing, transparent data-sharing, and regulatory accountability. Systemic Regulatory and Reporting Failures Dr. Rose’s VAERS analysis revealed systemic issues in adverse event reporting and follow-up. The exponential rise in adverse event reports, moving from 39,000 annually pre-COVID to over 750,000 during the first year of mRNA vaccine roll-out, suggests a significant underestimation of vaccine related risks. Regulatory agencies’ apparent lack of urgency in responding to these signals undermines public trust and raises ethical questions about vaccine promotion without robust safety evaluations. Both Dr. Bridle and Dr. Rose emphasized the need for independent oversight of regulatory bodies to address conflicts of interest and ensure unbiased monitoring of vaccine safety. The current reliance on manufacturers’ data without rigorous external review compromises the credibility of public health decisions, leaving gaps in accountability and transparency. Risks to Vulnerable Populations All three witnesses highlighted the disproportionate risks posed by mRNA vaccines to vulnerable groups, including children, pregnant women, and individuals with pre-existing health conditions. Dr. Bridle expressed alarm about the promotion of vaccines to pregnant women despite insufficient safety data, while Dr. Rose’s VAERS analysis showed elevated adverse event rates among children, particularly in the 12-17 age group. Dr. Thomas’s testimony expanded on the risks associated with current vaccination policies, particularly for infants and young children exposed to aluminum adjuvants and other vaccine components. His findings linked vaccination schedules to an increased prevalence of conditions like asthma, ADHD, and behavioural issues, calling for a more cautious approach to pediatric vaccination. The recurring theme across all testimonies is the failure of public health authorities to adopt a precautionary approach, instead prioritizing mass vaccination strategies without fully understanding the risks to vulnerable populations. Erosion of Public Trust in Health Systems The testimonies underscored the erosion of public trust in health institutions, fuelled by a lack of transparency, inadequate public consultation, and insufficient accountability. Dr. Bridle’s revelations about bio-distribution and bio-persistence contradicted public health messaging, raising questions about the credibility of regulatory agencies. Dr. Rose’s identification of contamination issues further undermined confidence in vaccine manufacturing processes. Public trust is foundational to effective public health strategies, and the failure to address safety concerns or respond to adverse event signals has significant implications for future vaccination campaigns. Witnesses consistently called for greater transparency, independent monitoring, and open communication to rebuild trust and ensure the safety of future public health initiatives. Conclusion The testimonies of Dr. Bridle, Dr. Thomas, and Dr. Rose underscore profound concerns about the safety of mRNA vaccines, the integrity of regulatory systems, and the ethics of public health practices. Their findings highlight significant gaps in oversight, transparency, and accountability, necessitating immediate action to rebuild public trust in Canada’s healthcare system. Recommendations Suspend mRNA Vaccine Roll-out: Implement an immediate moratorium on mRNA vaccines until independent safety verification is conducted. 2. Enhance Regulatory Oversight: Establish independent bodies to monitor vaccine safety and adverse events. Enforce stricter production standards to minimize contamination risks. 3. Improve Data Collection and Transparency: Mandate public reporting of all adverse events and ensure VAERS data is regularly updated and accessible. Conduct independent audits of vaccine trial data. Mandate publication of vaccine trials data. 4. Reevaluate Vaccine Policies: Promote informed consent by providing clear, accurate information on vaccine risks and benefits. Develop alternative public health strategies to reduce reliance on mass vaccination. 5. Support Research and Accountability: Fund long-term studies on the effects of mRNA injections. Hold manufacturers and regulatory agencies accountable for safety violations and data omissions. By implementing these recommendations, Canada can prioritize public safety and restore confidence in its healthcare systems. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
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5.1.7 Structural Importance of Schools in Society 5.1.7 Structural Importance of Schools in Society Recommendations Prioritize Schools in Crisis Response: Treat schools as essential services, ensuring they remain operational during crisis. Develop contingency plans to enable safe in-person or hybrid learning models. 2. Strengthen School-Based Health and Social Programs: Expand mental health resources and other support services within schools. Schools should not be used as platforms for public health initiatives such as vaccinations and health screenings. Health care and education should be separate. 3. Promote Civic and Social Engagement in Curricula: Integrate activities and lessons focused on civic responsibility and community engagement. Create opportunities for students to engage in collaborative projects that emphasize teamwork and social impact. 4. Enhance Community Involvement in Schools: Foster partnerships between schools, local organizations, families, and health providers to build robust support networks. Encourage community participation in school boards. 5. Develop Resilient Educational Policies: Advocate for federal and provincial policies that ensure educational continuity during emergencies. Include provisions for rapid deployment of digital resources and equitable access to technology for remote learning. 6. Implement Feedback Mechanisms for Policy Assessment: Establish systems to monitor the effectiveness of crisis response policies in education. Use data-driven insights to refine strategies and improve resilience over time. By reinforcing the role of schools as foundational institutions in times of crisis, these recommendations aim to ensure educational continuity, protect student well-being, and strengthen community ties. Prioritizing in-person learning, separating education from public health mandates, and embedding civic values into curricula will foster resilience, stability, and a deeper sense of connection between schools and the communities they serve. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
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6.2.2 The Effects of Sustained Propaganda and Terror 6.2.2 The Effects of Sustained Propaganda and Terror Recommendations Renate Lindeman’s testimony underscores the significant fear and anxiety experienced by many Canadians due to the COVID-19 pandemic and the accompanying public health measures. To address these concerns and prevent similar issues in the future, the following recommendations are proposed: Strengthening Legal Protections for Vulnerable Individuals Recommendation : Enact Robust Legal Safeguards Implementation : Introduce legislation that explicitly protects the rights of individuals with disabilities and other vulnerable populations. Assure that these protections cover medical decisions, including vaccination, and prevent any form of forced medical intervention. Rationale : Legal safeguards will protect the rights and autonomy of vulnerable individuals from coercive measures. Recommendation : Discontinue all Euthanasia and Assisted Dying Programs 2. Promoting Transparency and Accountability in Public Health Measures Recommendation : Ensure Transparent Decision-Making Processes Implementation : Require public health authorities to provide clear, evidence-based justifications for all public health measures. Hold regular public briefings and publish detailed reports on the rationale behind decisions. Rationale : Transparency in decision-making will build public trust and confirm measures are based on sound scientific evidence. Recommendation : Establish Independent Review Panels Implementation : Create independent review panels to assess and provide feedback on public health policies and their implementation. These panels should include experts from various fields, including ethics, law, and public health. Rationale : Independent review panels will ensure that public health measures are scrutinized and held to high ethical standards. 3. Enhancing Public Communication and Education Recommendation : Develop Comprehensive Public Education Campaigns Implementation : Launch public education campaigns to inform citizens about their rights, the importance of Informed Consent, and the ethical principles guiding public health measures. These campaigns should use multiple platforms to reach diverse audiences. Rationale : Educating the public will empower individuals to make informed decisions and understand the measures being implemented. Recommendation : Foster Open Dialogue and Community Engagement Implementation : Organize forums, town halls, and online platforms for open dialogue between public health officials and the community. Encourage feedback and address concerns transparently. Rationale : Open dialogue will help address public concerns, reduce fear, and build a collaborative relationship between the community and public health authorities. 4. Protecting Parental Rights and Child Welfare Recommendation : Uphold Parental Rights in Medical Decisions Implementation : Parents must have the final say in medical decisions affecting their children, especially regarding vaccinations and other medical treatments. Provide clear guidelines to protect these rights. Rationale : Upholding parental rights ensures that families can make decisions that are in the best interests of their children. Recommendation : Provide Support for Families with Special Needs Children Implementation : Increase support services for families with special needs children, including financial assistance, healthcare resources, and educational support. Ensure that these services are accessible and responsive to their needs. Rationale : Supporting families with special needs children will help them navigate public health measures without additional stress and anxiety. 5. Addressing and Mitigating Historical Parallels Recommendation : Acknowledge and Learn from Historical Mistakes Implementation : Publicly acknowledge historical events like the Nazi T4 program so that current and future public health policies do not repeat similar mistakes. Incorporate lessons from history into public health training and policy development. Rationale : Learning from history helps prevent the repetition of past injustices and ensures that public health measures are ethical and just. Recommendation : Implement Ethical Guidelines for Public Health Measures Implementation : Develop and enforce strict ethical guidelines for all public health measures. These guidelines would prioritize individual rights, Informed Consent, and the protection of vulnerable populations. Rationale : Ethical guidelines will safeguard against abuses and ensure that public health measures respect human rights and dignity. Addressing the concerns felt by Renate Lindeman and many other Canadians requires a multifaceted approach that prioritizes legal protections, transparency, public education, and ethical public health practices. By implementing these recommendations, Canada can rebuild trust in public institutions, protect vulnerable populations, and provide future public health measures that are both effective and respectful of individual rights. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
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9. Transcripts Intentionally left blank Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
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Conclusions Interim Authorization of Covid-19 Vaccine Introduction The Commission received detailed information about the procedure through which "approval" for COVID-19 vaccines was granted in Canada. According to the testimony, the conventional evaluation and endorsement process for the COVID-19 vaccines was not adhered to by the Canadian Government. Instead, a new process was established whereby Health Canada "authorized" the Covid-19 vaccines under an Interim Order (which was later adopted as a permanent regulation). It is important to understand that the Covid-19 vaccines were never approved under the traditional approval process for drugs in Canada. Under the alternative authorization process, the necessity to establish the safety and efficacy of Covid-19 vaccines through an objective manner appears to have been set aside. Objectively and independently proving the safety and efficacy of any new drug before its introduction into the market is an essential cornerstone of responsible healthcare and public safety. This rigorous requirement serves as a critical safeguard for individuals' well- being, ensuring that potential risks are thoroughly assessed and weighed against the benefits. This principle becomes even more pivotal when the drug is intended for widespread use across all segments of the population. The blanket use of a drug, especially one like the Covid-19 vaccines, necessitates an unassailable foundation of evidence. Rigorous testing, transparent evaluation, and independent verification of safety and efficacy are fundamental to instilling trust among both healthcare professionals and the general public. This approach ensures that medical interventions are based on the most accurate and reliable information available. In the context of a global health crisis, these principles are vital to ensuring that public health measures are not only effective but also respectful of individuals' rights and dignity. It is imperative that all drugs proposed to be released to the public be objectively and independently proven to be both safe and effective. It is for this reason that strict proof of safety and efficacy have been required by our drug approval regulations. The need to prove both safety and efficacy take on particular importance for drugs intended for the entire population, including children and pregnant women. This approach forms the bedrock of responsible medical practice and contributes to a society that values health, science, and the dignity of each person. Testimony Concerning Interim Authorization of Covid-19 Vaccines The following vaccines were authorized by Health Canada under the Interim Order: Pfizer-BioNTech on December 9, 2020 for ages 16 and older, and May 5, 2021 for ages 12-15; Moderna on December 23, 2020 for ages 18 and over and August 27, 2021 for ages 12-17; AstraZeneca on February 26, 2021 for ages 18 and older, and Janssen (Johnson & Johnson) on March 5, 2021 for ages 18 and older. The Commission received testimony from two key witnesses, Shawn Buckley and Deanna McLeod, regarding the procedure through which the authorization of Covid-19 vaccines took place in Canada. The initial authorization of all Covid-19 vaccines was provided under a temporary, Interim Order, which exempted them from the traditional regulations that demand manufacturers to demonstrate objective evidence of safety and effectiveness. The result was that while chief medical officers across the country repeatedly assured Canadians that the Covid-19 vaccines were "safe and effective" - the general Canadian population had no understanding that their authorization process had not required objective proof of safety nor efficacy. Shawn Buckley The Political Approval of the Covid Vaccine: A Constitutional Lawyer's Perspective The normal regulatory process for approving a new drug in Canada is set out in Division 8 of Canada's Food and Drug Regulations (the "Regulations”). To receive approval for a new drug in Canada, the Regulations require evidence of both the drug's safety and effectiveness be demonstrated to the Minister of Health. Once evidence of safety and efficacy is provided, the Minister considers whether the benefits outweigh the risks. If evidence of safety and effectiveness has been provided that shows the benefits outweigh the risk, the Minister may grant market approval of a new drug. These first steps of demonstrating safety and effectiveness, before approval, are essential to ensuring that Canadians are not exposed to unknown risks in the name of unknown effectiveness. The Federal Government’s creation of the Interim Order required Health Canada to approve the Covid-19 vaccines without proof of either safety or of efficacy which resulted in millions of Canadians taking a new drug whose safety and effectiveness could not be known. The unfortunate result of authorizing the Covid-19 vaccines through the Interim Order (instead of under the traditional approval process under the Regulations) was revealed through NCI testimony – many Canadians were injured or killed, while at the same time the Covid-19 vaccine was revealed not to be effective in preventing infection and transmission nor reducing the severity of illness. The benefit of hindsight demonstrates clearly why the traditional tests under the Regulations are needed for all new drug approvals, and why Canada should not authorize drugs under Interim Orders, even in cases of public health emergencies. The Traditional Drug Approval Process The requirements that must be met to approve a new drug in Canada are found in C.08.002(2) of the Regulations. Of particular importance are high requirements for proof of both safety and efficacy. These are found as follows: C.08.002(2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following: detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended; substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended[.] Under the traditional approval process in the Regulations the first step is to establish the safety profile of the new drug and demonstrate to the Minister of Health that the drug is safe for use in the human population. The second step is to establish the new drug’s benefit profile, in other words, is it effective, does it work. The third step, although not specifically included in the regulation, is to evaluate the Risk / Benefit profile for the drug. In other words, the regulatory review has to establish that the benefits of using the drug outweigh the risk of using the drug. One cannot satisfy the requirement for a risk/benefit analysis without a complete understanding of the drug's safety and benefit profile. Interim Order: Importation, Sale and Advertising of Drugs in Relation to COVID-19 Instead of following the Regulations, on September 16, 2021, the Minister of Health made an Interim Order exempting all Covid-19 drugs (including Covid-19 vaccines) from the normal review and approval process. The Interim Order was made under section 30.1 of the Food and Drugs Act, R.S.C., 1985, c. F-27, which permits the Minister of Health to make an interim order that overrides normal regulations. The section reads: 30.1 (1) The Minister may make an interim order that contains any provision that may be contained in a regulation made under this Act if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. The term “significant risk” is not defined in the Act, nor is there any proportionality built into this section. Thus, there do not appear to be any legislative safeguards or guidelines for when this power to override is used by the Minister of Health. Under this broad power, the Minister made the Interim Order which, rather than requiring significant evidence of safety and efficacy of the Covid-19 vaccines as mandatory requirements for approval, only required the vaccine manufacturers to provide: 3(1) … sufficient information and material to enable the Minister to determine whether to issue the authorization, including … (o) the known information in relation to the quality, safety and effectiveness of the drug. By letting the Minister make a decision based on "known information" about safety and effectiveness, this allowed the Covid-19 vaccines to be authorized in advance of actual knowledge about their safety or effectiveness. The Interim Order attempted to make up for this by having manufacturers promise to do more follow-up research as follows: 3(2) If, at the time an application is initially submitted to the Minister, the applicant is unable to provide information or material referred to in any of paragraphs (1)(g) to (k) and (m) to (o) or that information or material is incomplete, the applicant must include in the initial part of the application a plan as to how and when they will provide the Minister with the missing information or material. However, as will be discussed further below, the Interim Order also prevented the Minister from revoking authorization once given, meaning that the Minister was absolved of the responsibility to protect the public if subsequent safety problems were discovered in the Covid-19 vaccines. It is vital to recognize that when the Interim Order was issued, the Minister of Health at the time had attended Lakehead University, graduating with a Bachelor of Arts, and had received a Master of Public Administration from the University of Victoria. To our understanding, the minister possessed no medical training credentials that we would consider pertinent to making the required determinations under the regulations. Approval of Covid-19 Vaccines was virtually guaranteed under the Interim Order Remarkably, the Interim Order effectively required Health Canada to authorize a Covid-19 vaccine for use in the Canadian population even in the absence of detailed evidence of safety and substantial evidence of efficacy. Section 5 of the Interim Order provides: The Minister must issue an authorization in respect of a Covid-19 drug if the following requirements are met: the applicant has submitted an application to the Minister that meets the requirements set out in subsection 3(1) or 4(2); the applicant has provided the Minister with all information or material, including samples, requested under subsection 13(1) in the time, form and manner specified under subsection 13(2); and the Minister has sufficient evidence to support the conclusion that the benefits associated with the drug outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the necessity of addressing the urgent public health need related to Covid-19. The test set out in (c) above is startling when compared to the traditional test for new drugs under the Regulations. Under the traditional test, evidence of safety and efficacy must be proven. Under the Interim Order, there only needs to be "evidence to support the conclusion" that the benefits outweigh the risks. This does not mean the Minister (i.e., Health Canada) has to be convinced and actually reach the conclusion. If the test was to convince Health Canada, the test would read: the Minister has sufficient evidence to conclude The difference in language is important. Under this test, it appears that a vaccine would have to be authorized as long as there was sufficient evidence to support an argument that the benefits outweighed the risks. In addition, the risk versus benefit test need not be robust, as the Minister is to "have regard" for the "uncertainties" of the benefits and risks. It is not clear how the Minister is expected to perform a risk versus benefit analysis when there is insufficient safety and efficacy evidence to determine true risks versus benefits. It is even more unclear how to perform a risk versus benefit analysis while "having regard to the uncertainties" of the risks versus benefits. Ultimately, the Interim Order reveals that the Minister's priority was the "necessity of addressing the urgent public health need related to Covid-19." The problem, of course, is that under this test, the government placed its perceived "urgent public health need" ahead of safety and efficacy of the Covid-19 vaccines. This appears to be what the Government of Canada actually did. Regardless of whether the need for a drug is urgent, this cannot override a proper assessment of safety, particularly when Canadians are under the impression that a drug has been proven safe. The NCI was not made aware of any public health authority in Canada cautioning Canadians that the vaccines had been authorized without the traditional need to prove their safety. Instead, the Government of Canada was under enormous pressure in the media to secure vaccines and make them available to Canadians. In response, it placed orders for millions of doses from the manufacturers. This placed the Government in a conflict of interest because it had purchased and imported unapproved vaccines while it waited for itself to approve the vaccines. The Interim Order appears to have been designed to ensure that the vaccines would have no problem in receiving authorization. As indicated above, in the traditional drug approval process, chances are not taken. If there is uncertainty about either safety or efficacy, the drug is not approved. There must be strict objective evidence of both safety and efficacy. It must also be objectively clear that the benefits outweigh the risks before a new drug is approved. It can only be objectively clear that the benefits of a drug outweigh the risks when the benefits and risks are objectively known. The test for Covid-19 vaccines abandoned this need for objective certainty. Instead of requiring objective proof of: safety; efficacy, and benefit outweighing risk. The Covid-19 vaccines were authorized under a subjective test which mandated that authorization must be granted if an argument could be made to support the conclusion that the benefits outweighed the risk. The question arises: what if there was evidence that went both ways? In other words, what if there was evidence that pointed towards greater benefits, but there was also evidence that pointed towards risks? Under the Interim Order, it seems the Minister must then take into account the subjective factors of: uncertainty and the urgent public health need for a vaccine. This cannot be an appropriate standard for approving a drug that the Government intends to administer to the entire population. It is difficult to conceive of a less-scientific test for drug authorization than that found in the Interim Order. The Interim Order also ensured that the authorization of a Covid-19 vaccine could not be revoked: due to evidence the vaccine was unsafe or not-effective; due to assessments the benefits did not outweigh the risks. This resulted from the fact that once a vaccine was authorized under the Interim Order, most of the Regulations did not apply, including C.08.006. This particular regulation is the safeguard that allows the Minister of Health to cancel a drug’s market authorization if evidence is uncovered that the drug is not safe. Instead, the Interim Order contained its own vague safeguards allowing for cancellation only in a few limited circumstances. The exclusion of the Minister’s normal powers to revoke authorization, and the reliance on more restricted revocation powers under the Interim Order means that Canadians could not have confidence that the Covid-19 vaccines would be pulled from the market if there was evidence that they were not safe. This situation persisted for roughly a year. Were the Covid-19 Vaccines Approved Without Safety or Efficacy Proof? In addition to the Interim Order, Health Canada created a document called "Guidance for market authorization requirements for Covid-19 vaccines." This document is intended to provide guidance to pharmaceutical companies applying for market authorization. As it must, it follows the new subjective test for the vaccines. For example, the current version includes: About market authorizations for a Covid-19 vaccine Health Canada will grant authorizations only if we determine that the benefits of the vaccine outweigh its potential risks. We will base our decision on the evidence provided on the vaccine's safety, quality and efficacy. For vaccines relying on the modified requirements in C.08.002 (2.1) of the Food and Drug Regulations, the risk- benefit analysis weighs the uncertainties about a potential vaccine against the public health need for a vaccine at the time of the decision. Modified requirements for Covid-19 drugs make it possible for initial authorization, based on early data, while the manufacturer continues working on developing a vaccine. We will use terms and conditions to manage uncertainties or risk mitigation measures related to the vaccine in the context of public health. The NCI heard testimony that the Health Canada employee who authorized all of the Covid-19 vaccines swore an Affidavit for a lawsuit for Federal Court File No. T-145-22 in which she described the basis of Health Canada's authorization of the Pfizer/ BioNTech and Moderna vaccines. Instead of setting out the evidence relied on in support of the authorization, she simply parrots the words of the test. In the case of Pfizer/ BioNTech, she stated that Health Canada reviewed "quality (chemistry and manufacturing), non-clinical (pharmacology and toxicology), and clinical (immunogenicity, safety, and efficacy) information" and then concluded that "the evidence supports the conclusion that the benefits associated with the Pfizer.BioNTech COVID.19 Vaccine outweigh the risks, having regard to a shorter term (median of 2 months) follow up of safety and efficacy at authorization, and the necessity of addressing the urgent public need related to COVID.19." In the case of Moderna, she stated similarly that: "the evidence supported the conclusion that the benefits associated with the Moderna COVID.19 Vaccine outweighed the risks, having regard to a shorter term (median of 2 months) follow up of safety and efficacy at authorization, and the necessity of addressing the urgent public health need related to COVID.19." Notably, what she does not cite in support of the vaccine authorization is: objective proof of safety; objective proof of efficacy, and objective proof that the benefits outweigh the risks. Based on testimony to the NCI, and without further evidence from Health Canada, we cannot conclude that Health Canada properly evaluated the safety and efficacy of the Covid-19 vaccines before authorization. To the contrary, the authorization of the vaccines appears to have been all but pre-assured by the creation of the Interim Order. The Interim Order Has Become Permanent The Interim Order can only last for a maximum of one year. The Interim Order, therefore, was replaced on March 18, 2021, with permanent regulations that codify the subjective authorization test discussed above. The only notable change between the test in the Interim Order and the new permanent regulation is that the "public health need" that needs to be addressed is no longer described as urgent. Recall that the Interim Order required an examination of risks and benefits, while: “having regard to “the necessity of addressing the urgent public health need related to Covid-19" Now the test simply requires Health Canada to give consideration to “the public health need related to Covid-19.” Thus, under the permanent test, Health Canada no longer has to be swayed by urgency, but simply by the public health need related to Covid-19. In this way, it seems that so long as Covid-19 is a circulating virus, Health Canada must authorize any vaccine for which there is an argument to support the conclusion that its benefits outweigh its risks. In effect, we fear that there will never be a need for Covid-19 vaccine manufacturers to prove safety or efficacy of their products. On a positive note, the NCI heard that the Minister's ability to revoke authorization of Covid-19 vaccines is now subject to the same regular rules as other drugs that are approved for the market. It does beg the question, however, of why was that particular rule modified for Covid-19 vaccines in the first place? Conflict of Interests for the Approval of Experimental Vaccines Canada normally prohibits drugs from being imported into Canada unless they have been approved by Health Canada for use in humans. Despite this, the Interim Order allowed unapproved and unauthorized Covid-19 vaccines to be imported into Canada as long as the Canadian Government was the purchaser. This was called pre-positioning in the Interim Order, and later in the Regulations codifying the Interim Order. The rationale was to assist Canada in expediting its response to the perceived Covid-19 crisis, by pre-purchasing and distributing the vaccines so they would be ready as soon as they were authorized. However, this created a tremendous conflict of interest. Once the vaccines were purchased, imported and ready for distribution, the Government of Canada would have suffered significant political blowback if it was unable to authorize them. Thus, it needed to authorize the Covid-19 vaccines, and it needed to do it quickly. The Government of Canada essentially put itself in charge of authorizing a drug that it had spent millions of public dollars on, had promised publicly on many occasions, and that it wanted to administer to every Canadian citizen. The authorization of the Covid-19 vaccines was all but guaranteed. The Government of Canada ordered the vaccines, imported them, created new regulations to authorize them, and then took significant measures to convince and coerce every Canadian to take multiple doses. The political stakes were high, and the federal government had every motivation to get the vaccines authorized, regardless of their actual efficacy or safety. There was no opportunity for sober second thought. There was no impartial oversight. The entire authorization process appears to have been "gamed" for one result, and one result only: authorization of vaccines for every Canadian, including children. Once the federal Government made mass-vaccination its priority, it should no longer have been solely responsible for their authorization. Timing of the Interim Order The timing of the Interim Order is also curious and coincident. Notably, the September 16, 2020 Interim Order was created just two weeks before AstraZeneca's authorization application was filed with Health Canada, and just three weeks before Pfizer filed on October 8, 2020. Since the authorization applications were made under the Interim Order, they would have been structured to meet the requirements of the Interim Order. Perhaps an authorization application is a standard document, however, the NCI suspects that it would be difficult for a company to prepare a detailed authorization application without knowing what the authorization requirements were going to be. For this reason, there are further questions that need to be answered about how the applications could have been filed so quickly in a manner that satisfied the subjective test, and whether there was participation in creating, or knowledge of the contents of, the test in advance. Phase Three Trial Data Alleged Manipulation of Data Deana McLeod Insights into Covid Vaccine Approval and Trials Deana McLeod's testimony has raised important concerns about the means and methods used in testing Covid-19 vaccines. Her testimony primarily centred on potential conflicts of interest and biases within the teams responsible for conducting and reporting Phase Three test data, which was submitted to Health Canada. Additionally, McLeod shed light on Pfizer's historical legal issues and the broader issue of potential conflicts of interest within the regulatory and approval sector. Her testimony echoed Mr. Shawn Buckley's prior statement that objective tests demonstrating safety and efficacy were omitted from these products. Financial incentives at various stages of the testing and authorization process were also discussed, prompting the need for a thorough examination of motivations. McLeod's testimony serves as a reminder of the importance of transparency, objectivity, and independence in the testing and approval of medical products, especially when it concerns a global health crisis. The potential for conflicts of interest and biases within such a critical process can erode public trust and compromise the credibility of the regulatory framework. The reference to Pfizer's past legal issues underscores the necessity for scrutinizing the track record of pharmaceutical companies involved in the development of vaccines or drugs. The public has a right to be informed about any potential historical shortcomings or ethical concerns that might impact the reliability of the products in question. The removal of objective safety and efficacy tests from the products raises alarming questions about the standards applied to these vaccines. Rigorous testing is the cornerstone of any vaccine's credibility and the foundation of public trust. Omitting such tests potentially undermines the credibility of the entire testing and approval process. The mention of financial motivations at various levels of testing and approval emphasizes the need for greater transparency and accountability within the industry. The potential for financial incentives to influence decision-making is a cause for concern and demands further investigation to ensure that public health is prioritized over financial gain. Lastly, the allusion to Statistics Canada data provided during the testimony highlights the need for comprehensive, reliable, and complete data when assessing the impact of any medical intervention. It is crucial to base decisions on thorough and unbiased information to ensure the well-being of the population. In conclusion, Deana McLeod's testimony raises vital questions about the processes, motivations, and ethics involved in Covid-19 vaccine testing and authorization. This testimony underscores the necessity for transparent, objective, and unbiased approaches in these critical endeavours. The concerns raised must prompt a broader discussion about regulatory practices, industry accountability, and the integrity of medical interventions in the interest of public health and safety. Conclusions There appeared to be a disconnect between Health Canada messaging concerning vaccine approval and the actual test used for authorization. As indicated above, safety, efficacy and whether the benefits of the vaccines outweighed the risks did not need to be proven under the Interim Authorization process employed by Health Canada. Despite the novel nature of the vaccines – in particular those using mRNA – the pharmaceutical companies did not have to objectively prove their safety and efficacy. It should be noted that the special authorization process created under the Interim Order was not mandatory, and pharmaceutical companies still had the option to apply for approval under the regular test which required objective proof of safety, efficacy and cost/ benefit. The pharmaceutical companies did not choose to objectively prove safety, efficacy and cost/benefit. They chose to apply under the Interim Order test, and regulators did not require it of them. Of great concern is the disconnect between Health Canada's public messaging about the Covid-19 vaccines as safe and effective when the regulatory authorization process clearly does not require these be objectively demonstrated. Health Canada continues to message to the public that the regular drug approval requirements of safety and efficacy were met. For example, at the top of Health Canada’s website page for the Pfizer vaccine, Health Canada states: All Covid-19 vaccines authorized in Canada are proven safe, effective and of high quality [emphasis in the original]. Recommendations Newly implemented revisions to the Food and Drug Regulations related to the authorization of Covid-19 vaccines must be rescinded as they permanently exempt Covid-19 vaccines from the requirements to objectively prove the Safety or Efficacy as required under the Food and Drug Regulations. The current use of Covid-19 vaccines in Canada that were authorized under the revised provisions of the Interim Order and the newly revised Food and Drug Regulations, should be stopped immediately. A full judicial investigation of the process under which the Covid-19 vaccinations were authorized in Canada must be carried out. Criminal liability, if discovered, may be dealt with under existing Canadian law. All documentation concerning the authorization process and information provided to the regulatory agencies by the manufacturers should be made publicly available. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
- NCI-R-03-Item-6-4-2 | National Citizens Ar
6.4.2 Adverse Reactions and Reporting Issues 6.4.2 Adverse Reactions and Reporting Issues Recommendations The Regina testimonies and the 2023 NCI Report collectively underscore the need for significant improvements in the adverse event reporting systems: Immediately Discontinuing Use of mRNA vaccines. Enhance Healthcare Provider Education: Educate and encourage healthcare providers to report adverse events without fear of reprisal. Improve Reporting Systems: Make reporting systems more accessible and user-friendly for both healthcare providers and patients. Increase Transparency: Ensure transparent communication about the risks of vaccines, including the acknowledgment and investigation of adverse events. Conduct Comprehensive Studies: Perform mid-term and long-term studies on vaccine safety to better understand the potential risks associated with all vaccines. Promote Public Engagement: Engage the public in reporting adverse events and educate them about the importance of reporting. These steps are essential to address the gaps identified in the Regina testimonies and the 2023 NCI Report and to ensure a robust system for monitoring vaccine side effects and protecting public health. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.
- NCI-R-03-Item5-4-2 | National Citizens Ar
5.4.2 Adverse Reactions and Reporting Issues 5.4.2 Adverse Reactions and Reporting Issues Introduction The testimonies from the recent NCI hearings in Regina brought to light significant concerns regarding adverse reactions to the COVID-19 vaccines and issues with the reporting systems. These issues are critical because they highlight potential gaps in our understanding of vaccine safety and the effectiveness of the systems in place to monitor and address these concerns. The November 28, 2023 NCI Report corroborates these concerns with substantial evidence. Testimonies on Adverse Reactions and Reporting Issues Dr. Jessica Rose Findings : Dr. Rose’s analysis of the VAERS data indicated a significant underreporting of adverse events. She stated that VAERS, being a voluntary system, underreports actual adverse events by a factor of 31 times. This means that the actual number of adverse events would be much higher than reported. Comparative Data : According to Dr. Rose, adverse events related to the COVID-19 vaccines were approximately 116 times higher than those related to influenza vaccines. Specifically, the COVID-19 vaccine resulted in 25 times more adverse effects per million injections and about 70 times more deaths per million injections when compared to influenza vaccines. Cancer Rates : Dr. Rose emphasized an increase in cancer incidence potentially related to DNA and RNA contamination in the vaccines during the manufacturing process. This contamination has been confirmed by several independent laboratories. The inclusion of SV40, a known cancer-causing agent, was particularly concerning. Dr. Pierre Kory Findings : Dr. Kory’s testimony highlighted the resistance to early treatment options like ivermectin and how the focus was shifted toward promoting vaccines despite emerging safety signals. He pointed out the significant censorship and discrediting of alternative treatments and early adverse event reporting. Dr. Robert Chandler Adverse Reactions in Women : Dr. Chandler presented data indicating that 72 per cent of adverse reactions were found in women, with 16 per cent involving the reproductive system. This raises significant concerns about the impact of the vaccines on women’s health, particularly regarding fertility and pregnancy outcomes. Live Birth Rates : He noted a significant drop in live births following vaccination that suggests a potential link between vaccination and reproductive health issues. General Issues with Reporting Systems (From the November 2023 NCI Report) Healthcare Provider Reluctance : Many testimonies, including those from Dr. Gregory Chan and Dr. Charles Hoffe, indicated that healthcare providers faced obstacles in reporting adverse events. These included technical difficulties with reporting systems, lack of response from public health authorities, and fear of professional repercussions. Patient Reports Dismissed : Patients’ adverse reactions were often dismissed by healthcare providers. For instance, Nurse Angela Taylor experienced a severe reaction that was not reported, and Kristin Ditzel’s adverse reaction was not acknowledged as being related to the vaccine. Corroborating Evidence from the 2023 NCI Report The 2023 NCI Report provides detailed evidence supporting these testimonies: Underreporting and System Failures Fatal Flaws in Reporting Systems : The 2023 Report highlighted the flaws in the adverse event reporting systems, particularly their reliance on healthcare professionals to report events. Many healthcare workers were discouraged from reporting, and some faced professional risks for doing so. Broken Monitoring System : The 2023 NCI Report described a “broken, impossible to use system,“ where accurate and timely reporting of adverse events was hindered by gatekeepers and administrative obstacles. Data Analysis and Early Detection Importance of Robust Systems : The 2023 Report emphasized the need for comprehensive and user-friendly reporting systems to detect and respond to all potential side effects, especially for novel vaccines using unprecedented technology. Lack of Mid- and Long-Term Testing : It was noted that no mid-term or long-term testing was conducted prior to the approval of COVID-19 vaccines, which makes post-market surveillance critical for identifying adverse effects that were not evident in initial trials. Public Trust and Data Transparency Building Public Trust : Transparent and effective monitoring of vaccine adverse reactions is crucial for maintaining public trust. The 2023 NCI Report stressed that the lack of transparency and the dismissal of adverse events contributed to growing public distrust in the vaccination program. Recommendations The Regina testimonies and the 2023 NCI Report collectively underscore the need for significant improvements in the adverse event reporting systems: Immediately Discontinuing Use of mRNA vaccines. Enhance Healthcare Provider Education: Educate and encourage healthcare providers to report adverse events without fear of reprisal. Improve Reporting Systems: Make reporting systems more accessible and user-friendly for both healthcare providers and patients. Increase Transparency: Ensure transparent communication about the risks of vaccines, including the acknowledgment and investigation of adverse events. Conduct Comprehensive Studies: Perform mid-term and long-term studies on vaccine safety to better understand the potential risks associated with all vaccines. Promote Public Engagement: Engage the public in reporting adverse events and educate them about the importance of reporting. These steps are essential to address the gaps identified in the Regina testimonies and the 2023 NCI Report and to ensure a robust system for monitoring vaccine side effects and protecting public health. Report Content Reader Page 📄 Note to Readers The content presented on this page has been adapted for online viewing and navigation. Due to formatting limitations within the web display system, certain elements—such as layout, spacing, and visual structure—may differ slightly from the original report. For the complete and fully formatted version, we encourage you to download the official PDF available on the Report Information page. The PDF reflects the report exactly as it was originally written and published.



