7.5.10 Canada‘s Vaccine Adverse Reactions Reporting System

Introduction

A robust vaccine adverse reaction reporting system in Canada is crucial to ensure the ongoing safety and efficacy of vaccines. The need for it was particularly acute during the COVID-19 pandemic since the pharmaceutical industry developed an injection that utilized novel technologies.

The basis of these injections was the mRNA technology, which had never before been deployed within the general population. As well, the development and testing of the Pfizer-BioNTech and Moderna COVID-19 injections were completed in less than one year, which is exceptionally rapid for a new type of medical treatment. The normal period of time for the development and testing of new biological drugs and vaccines is between five and ten years.

Furthermore, within that one year time period, not only was the scientific development of the vaccine completed but so was the development of the requisite mass manufacturing processes and facilities.

According to witnesses, a truncated testing of the laboratory-produced vaccines was carried out over a limited two-month test period, and no testing was carried out on the final product from the manufacturing facilities.

The requirement for the manufacturers to demonstrate objective proof of the safety and efficacy of the new product was waived by the Interim Authorization Order. On September 16, 2021, the Minister of Health issued an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. This Interim Order exempted the COVID-19 vaccines from Health Canada‘s normal review and approval process.

According to Dr. Peter McCullough, given the characteristics and functions of the mRNA vaccines, they should be classified as biologics, necessitating a significantly greater in-depth testing protocol than traditional vaccines due to the risk of adverse effects.

The Canadian public was never made aware of these issues.

On December 9, 2020, the Government of Canada issued a press release concerning Health Canada‘s authorization of the first COVID-19 genetic vaccine.

Here are relevant excerpts from it:

Thanks to advances in science and technology, and an unprecedented level of global cooperation, today, Canada reached a critical milestone in its fight against COVID-19 with the authorization of the first COVID-19 genetic vaccine.

Health Canada received Pfizer‘s submission on October 9, 2020 and after a thorough, independent review of the evidence, Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department‘s stringent safety, efficacy and quality requirements for use in Canada.

As part of its continued commitment to openness and transparency, Health Canada is publishing a number of documents related to this decision, including a high-level summary of the evidence that Health Canada reviewed to support the authorization of the vaccine. More detailed information will be available in the coming weeks, including a detailed scientific summary and the full clinical trial data package.

The press release goes on to insist that

Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place. Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified.

This section of the report examines the statement by the Government of Canada that they had “strong monitoring systems in place.“

Testimony Concerning Canada‘s Vaccine Adverse Reactions Reporting System

Although the discussion of this subject by its very nature is convoluted, it is not necessarily complex. To properly understand the issues surrounding Canada‘s vaccine adverse reactions reporting system, one must first understand why such a system was necessary in the case of the COVID-19 injections.

What follows is a discussion of the COVID-19 injections, the process by which they were approved, the evolving definitions used to justify their use, a description of the system that Health Canada told Canadians was in place, and a discussion of the actual system that was in place as described by witness testimony.

In the normal course of events, it is imperative that a rigorous reporting system be available to monitor the safety of any drug administered to the general population.

The “normal course of events“ would have included years of laboratory development; peer-reviewed, independent testing; monitoring of any and all adverse events in the various test groups over a number of years to guard against unknown long-term effects; and the proper classification of the new treatment based on the way it acts on and effects the body. Historically, this process takes between 5–10 years, and sometimes more, depending on the nature of the treatment being evaluated.

The safety and efficacy of any treatment must be proven to regulators based on a cost–risk–benefit analysis carried out on objective and independent evaluations prior to its approval for use.

These conditions were not met in the case of the COVID-19 injections.

The COVID-19 injections were exempted from the normal requirement of their objective proof of safety and efficacy, even though these mRNA-type injections had never before been used in the general population. In addition, regulatrs classified these treatments in such a way that they required less stringent criteria for their approval despite their novelty.

Witnesses testified that these injections should have been classified as a biologic treatment rather than a simple vaccine as well as that the actual definition of a vaccine was revised to include these new and unproven experimental injections.

The primary difference between a biologic and a traditional vaccine lies in their composition, manufacturing process, and mechanism of action. What follows is a breakdown of the distinction between them.

Biologics:

Biologics are medicinal products derived from living organisms such as proteins, nucleic acids, cells, or tissues. They can include monoclonal antibodies, recombinant proteins, hormones, growth factors, and gene therapies.

Biologics are manufactured using complex and highly regulated processes that involve living organisms or their components. These processes often require advanced biotechnology techniques, such as cell culture, recombinant DNA technology, or gene expression systems.

Biologics typically act by targeting specific molecules, receptors, or pathways in the body. They can modulate the immune system, inhibit or enhance specific cellular functions, or replace deficient proteins or cells.

The mRNA injections have all of these characteristics and therefore should have been treated and approved as biologics instead of as vaccines.

Traditional Vaccine:

Traditional vaccines are typically composed of weakened or inactivated forms of infectious agents, such as viruses or bacteria, or specific components derived from these pathogens. They may also contain adjuvants or additives to enhance the immune response.

Traditional vaccines are produced using well-established techniques, including viral or bacterial propagation, inactivation, attenuation, or extraction of specific components. Some vaccines are also produced using recombinant DNA technology.

The CDC previously had defined a vaccine as

A product that produces immunity therefore protecting the body from the disease. Vaccines are administered through needle injections, by mouth and by aerosol.

Key Differences:

Biologics are more complex in structure and have much more complex manufacturing processes compared to traditional vaccines.

Biologics often target specific molecules, pathways, or cells in the body, whereas vaccines primarily focus on generating an immune response against specific pathogens.

Compared to vaccines, biologics have a broader range of therapeutic applications beyond infectious diseases, which include treatments for cancer, autoimmune disorders, and genetic diseases. Vaccines, in contrast, primarily focus on preventing or treating infectious diseases.

Before the COVID-19 injections, biologics and vaccines followed distinct, separate regulatory pathways. Biologics are typically regulated as biological products, while vaccines have specific regulatory guidelines and requirements.

Vaccine Definition Changed

In the years leading up to the declaration of the COVID-19 pandemic, the CDC changed the definitions of immunization, vaccination and vaccine multiple times.

Here is a comparison of some of the changes in these definitions.

Traditional Definition of a Vaccine:

The traditional definition of a vaccine referred to a substance that contains weakened or inactivated forms of pathogens (viruses or bacteria) or specific components derived from them. The primary goal of traditional vaccines was to stimulate the immune system, leading to the production of antibodies and the development of immunological memory. This immune response provided protection against subsequent exposure to the actual infectious agent, thereby preventing disease.

In July 2014, the CDC provided the following definition of immunization, vaccination, and vaccine:

Immunization: The process by which a person or animal becomes protected against a disease. This term is often used interchangeably with vaccination or inoculation.

Vaccination: Injection of a killed or weakened infectious organism in order to prevent the disease.

Vaccine: A product that produces immunity therefore protecting the body from the disease. Vaccines are administered through needle injections, by mouth and by aerosol.

Revised Definition of a Vaccine:

The current definition of vaccine encompasses a broad range of technologies and mechanisms. It includes traditional vaccines as well as a variety of new, experimental treatments, which have no relation to what or how traditional vaccines are developed or affect the body. Presenting them to the public under the familiar and widely trusted definition of vaccine disguises their true experimental nature.

Experimental vaccine platforms in the revised definition include

1. Viral Vector Vaccines: These use a modified “harmless“ virus (the vector) to deliver genetic material from the target pathogen into cells, triggering an immune response.

2. mRNA Vaccines: These introduce a small piece of genetic material (messenger RNA) that encodes the production of a specific viral protein. This mRNA is taken up by cells, which then produce the viral protein, triggering an immune response.

3. Protein Subunit Vaccines: These contain specific proteins derived from the target pathogen, rather than the whole pathogen. These proteins can, by themselves, elicit an immune response.

4. DNA Vaccines: These introduce a small piece of DNA that encodes the production of specific proteins from a targeted pathogen. The cells take up the DNA and produce the viral protein, initiating an immune response.

5. Vector-based DNA/RNA Vaccines: These combine elements of Viral Vector and DNA/RNA technologies to deliver genetic material into cells for protein production and immune stimulation.

The new, revised definition includes various technologies that trigger an immune response, generate immunological memory, and thereby confer protection against specific pathogens. It includes treatments and delivery methods that are new and experimental and had never before been used on the general population, at least in theory.

At the time these treatments were introduced to the general public, there had been no long-term studies to determine the risk they posed.

During the pandemic, the CDC changed and revised the definition of these terms on the fly, adjusting the definition of vaccine in order to include the COVID-19 injections, thereby justifying their introduction despite the lack of long-term safety data.

To illustrate how relevant definitions have changed, the CDC provided the following definition of immunization, vaccination and vaccine in July 2014:

Immunization: The process by which a person or animal becomes protected against a disease. This term is often used interchangeably with vaccination or inoculation.

Vaccination: Injection of a killed or weakened infectious organism in order to prevent the disease.

Vaccine: A product that produces immunity therefore protecting the body from the disease. Vaccines are administered through needle injections, by mouth, and by aerosol.

From May 16, 2018 to September 1, 2021 the CDC used the following definition for immunity, vaccine, vaccination and immunization:

Immunity: Protection from an infectious disease. If you are immune to a disease, you can be exposed to it without becoming infected.

Vaccine: A product that stimulates a person‘s immune system to produce immunity to a specific disease, protecting the person from that disease. Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.

Vaccination: The act of introducing a vaccine into the body to produce immunity to a specific disease.

Immunization: A process by which a person becomes protected against a disease through vaccination. This term is often used interchangeably with vaccination or inoculation.

This was later revised to the following:

Immunity: Protection from an infectious disease. If you are immune to a disease, you can be exposed to it without becoming infected.

Vaccine: A preparation that is used to stimulate the body‘s immune response against diseases. Vaccines are usually administered through needle injections, but some can be administered by mouth or sprayed into the nose.

Vaccination: The act of introducing a vaccine into the body to produce protection from a specific disease.

Immunization: A process by which a person becomes protected against a disease through vaccination. This term is often used interchangeably with vaccination or inoculation.

Rather than ensuring that a novel treatment could satisfy the definition of what a vaccine can do, the CDC adjusted the definition of vaccine, tailoring it to suit new technologies developed and promoted by the pharmaceutical industry, which the CDC is supposed to regulate.

The definition of these terms was revised dozens of times between 2014 and 2023.

The revised definitions have blurred the lines between biologics and vaccines. Drugs that can now be called vaccines, like those based on viral vectors or mRNA technology, exhibit characteristics of both traditional vaccines and biologics. The distinction lies in their composition, manufacturing, and mechanism of action.

The above discussion demonstrates how the process that led to the manufacture and development of the COVID-19 vaccines was unlike any drug development or approval process ever before undertaken.

The COVID-19 vaccines were based on novel technologies, which had never been used in the general population before; the process of development and testing was shortened from 5–10 years to a year or less; the key requirements of the approval process related to safety and efficacy were set aside; long term testing on population groups approximating the general population were never done; and the very definition of what the drugs were and supposed to do, kept changing.

These and many other issues contributed to an unprecedented level of risk and uncertainty with these new drugs.

The need to have a robust safety monitoring system was extreme.

Safety issues related to the development, manufacturing, and distribution of prescription drugs can arise from various technological, manufacturing, and distribution factors. Here are some key areas where safety concerns may arise:

Technological Issues:

1. Formulation and Stability: Inadequate understanding of the drug‘s chemical properties or formulation can lead to stability issues, resulting in reduced efficacy or potential safety risks.

2. Drug–Device Interactions: If a drug requires specialized delivery devices or technologies, compatibility issues between the drug and the device can arise, affecting drug effectiveness and patient safety.

3. Nanotechnology and Biologics: Advancements in nanotechnology and biologics have introduced complex manufacturing processes and potential safety concerns due to their unique characteristics and potential interactions with the human body.

Manufacturing Issues:

1. Contamination and Cross-Contamination: Improper handling or contamination during the manufacturing process can introduce impurities, foreign substances, or microbial contaminants, compromising the drug‘s safety and quality.

2. Quality Control and Assurance: Insufficient quality control measures or inadequate adherence to Good Manufacturing Practices (GMP) can lead to inconsistencies in drug potency, purity, or dosage, posing risks to patients.

3. Scale-up Challenges: Transitioning from laboratory-scale production to commercial-scale manufacturing may introduce unforeseen safety issues if the process is not properly optimized or validated.

Distribution Issues:

1. Counterfeit Drugs: Illegitimate or counterfeit drugs can enter the distribution chain, potentially lacking active ingredients, containing harmful substances, or having incorrect labelling, leading to patient harm.

2. Storage and Transportation: Inadequate storage conditions, temperature excursions, or mishandling during transportation can compromise drug integrity and efficacy, impacting patient safety.

3. Supply Chain Integrity: Complex global supply chains increase the risk of drug diversion, unauthorized tampering, or substitution, compromising the safety and authenticity of the medication.

Post-Marketing Surveillance:

1. Adverse Drug Reactions (ADR): Even after thorough premarket clinical trials, some adverse reactions may only emerge once a drug is widely used. Robust post-marketing surveillance systems are crucial for detecting and monitoring ADRs to ensure timely intervention and patient safety.

2. Labelling and Risk Communication: Inaccurate or insufficient drug labelling, which include warnings, contraindications, and precautions, can lead to improper use, misunderstandings, or increased safety risks for patients and healthcare providers.

To address these safety issues, regulatory bodies like Health Canada are tasked with establishing and enforcing stringent regulations and guidelines.

Pharmaceutical companies are also responsible for implementing quality management systems, conducting thorough risk assessments, and continuously monitoring and improving their manufacturing processes to ensure drug safety.

Collaborative efforts between regulatory agencies, manufacturers, healthcare professionals, and the public are essential to minimize safety risks associated with prescription drugs and ensure the highest possible level of patient safety throughout the drug development, manufacturing, and distribution lifecycle.

The most important part of a safety monitoring system must engage areas of society which will be subjected to the new drug. This includes patients, healthcare providers, pharmacies, regulators, and the manufacturers themselves.

Following are the goals of a functioning adverse events monitoring system:

Safety Monitoring: Vaccines undergo testing before they are approved for public use, but monitoring their safety post-approval is equally important. A reporting system allows healthcare professionals and individuals to report any adverse reactions they observe after vaccination.

By collecting and analyzing this data, health authorities can identify potential safety concerns, evaluate the risks versus benefits, and take necessary actions to protect the population.

Early Detection of all Side Effects: In a completely new drug based on a never-before-implemented technology utilizing a highly complex manufacturings process, it is impossible to predict before-hand exactly what level and types of adverse events may occur in the diverse general population. A comprehensive reporting system helps identify and investigate all side effects that may not have been detected during the initial clinical trials due to limited sample sizes. Early detection enables swift responses, which includes further investigation, changes in vaccination strategies, or updates to vaccine recommendations.

This is especially important for COVID-19 injections as no mid-term or long-term testing was carried out prior to approval for use in the general population.

Building Public Trust: Transparent and effective monitoring of vaccine adverse reactions helps build public trust in vaccination programs. When people have confidence that their concerns are being acknowledged, investigated, and acted upon, they are more likely to participate in adverse events reporting efforts. A robust reporting system assures the public that their safety is a priority and that the healthcare system is committed to addressing any potential risks associated with vaccines.

Data-driven Decision Making: Accurate and timely reporting of adverse reactions provides valuable data for decision-making processes. Health authorities can analyze the reported cases to understand the characteristics of adverse reactions, such as their frequency, severity, demographics, and potential risk factors. This data can inform vaccine recommendations, guide public health policies, and support regulatory decisions regarding vaccine safety.

Continuous Vaccine Improvement: A reporting system facilitates continuous monitoring and improvement of vaccines. By collecting information on adverse reactions, health authorities can identify patterns, assess the effectiveness of existing vaccines, and guide the development of future vaccines. This knowledge helps researchers and manufacturers make necessary adjustments to vaccines to enhance their safety profiles and minimize potential side effects.

Global Collaboration: Adverse reaction reporting systems also contribute to international collaboration and information sharing. By participating in global networks, Canada can share its data and benefit from the experiences and knowledge of other countries. This collaboration strengthens global vaccine safety monitoring efforts and enables the identification of potential adverse events that may be specific to certain populations or regions.

The need for a robust vaccine adverse reaction reporting system in Canada is essential for monitoring vaccine safety, detecting all side effects, building public trust, making data-driven decisions, improving vaccines, and facilitating global collaboration. It serves as a critical tool in ensuring the ongoing success of vaccination programs and protecting the health of the population.

What the Adverse Events Monitoring System was Supposed to Be

In Canada, vaccine safety monitoring is supposed to be conducted through various mechanisms and systems. Below are some key components of vaccine safety monitoring in Canada:

1. Canadian Adverse Events Following Immunization Surveillance System (CAEFISS):

• CAEFISS is also known as the Canadian Immunization Monitoring Program.

• Active (IMPACT) is a national surveillance program for monitoring adverse events following immunization (AEFIs) in children. It collects AEFI data from 12 pediatric tertiary care centres across Canada and analyzes the data to identify patterns, trends, and potential safety signals related to vaccines.

1. Vaccine Adverse Event Reporting System (VAERS) United States:

• VAERS is a national passive surveillance system that allows healthcare providers, vaccine manufacturers, and the public to voluntarily report adverse events following immunization.

• It serves as an important tool for detecting and monitoring potential safety concerns associated with vaccines.

1. Provincial and Territorial Vaccine Safety Surveillance:

• Each Canadian province and territory has its own vaccine safety surveillance system, which monitor and investigate adverse events related to vaccines administered within their jurisdictions.

• These systems contribute to the overall vaccine safety monitoring efforts in Canada.

1. Vaccine Safety Research and Studies:

• Canadian researchers conduct studies and research projects to investigate vaccine safety concerns, assess the effectiveness of vaccines, and monitor long-term safety outcomes.

  • These studies often involve collaborations with academic institutions, healthcare providers, and government agencies.

1. Collaboration with International Vaccine Safety Networks:

• Canada actively participates in international collaborations and networks, such as the World Health Organization‘s Global Vaccine Safety Initiative and the Vaccine Safety Datalink in the United States.

• These collaborations facilitate the exchange of information, including the sharing of best practices, and joint investigations of vaccine safety issues.

1. Regulatory Oversight and Post-Market Surveillance:

• Health Canada, the federal regulatory agency, oversees the approval and ongoing monitoring of vaccines.

• Health Canada conducts post-market surveillance activities to monitor the safety of vaccines after they are approved and distributed.

• It collaborates with provincial and territorial health authorities, healthcare professionals, and other stakeholders to ensure comprehensive vaccine safety monitoring.

1. Adverse Event Following Immunization (AEFI) Reporting:

• Healthcare providers are responsible for reporting any adverse events following immunization to the local public health authorities or relevant surveillance systems.

• Timely and accurate reporting of AEFIs is crucial for monitoring and investigating potential safety concerns.

Through these mechanisms, Health Canada claims to ensure continuous vaccine safety monitoring, early detection of potential adverse events, and prompt response to emerging safety concerns.

Health Canada also claims that their regular data analysis, collaboration, research, and regulatory oversight play significant roles in maintaining a robust vaccine safety monitoring system in the country.

The system described above, certainly sounds like the robust safety monitoring system that Health Canada reassured Canadians that they had in place to protect Canadians.

The reality of the system on the ground, as described by the testimony of witnesses, was that of a broken, impossible to use system, with gate-keepers who prevented accurate and timely reporting of adverse events.

The Broken Monitoring System Canadians Got

The entire adverse events reporting and monitoring system has a fatal flaw: it relies only on reports of adverse events received by healthcare professionals. Furthermore, these reports were discouraged, hindered, and rejected by local public health officers, and healthcare professionals were punished for reporting adverse events.

Patient Reporting of Adverse Events

Patients are not able to directly report adverse events to the CAEFISS reporting system. These reports must be funnelled through the healthcare providers.

According to Health Canada:

CAEFISS reports are submitted by public health authorities in provinces and territories, who in turn receive them from local public health units. Provincial and territorial authorities also receive reports from federal authorities that provide immunization within their jurisdiction, including:

• the RCMP,

• Indigenous Services Canada, and

• Correctional Service Canada.

Most of these reports are generated by nurses, physicians, or pharmacists who provide immunizations or who care for individuals with AEFIs. AEFIs received by National Defence and the Canadian Armed Forces are reported directly to PHAC.

Several witnesses testified that healthcare providers would outright deny or even refuse to consider claims of adverse reactions.

Concerns from patients related to adverse reactions were played down or dismissed by doctors, despite the fact that since the mRNA vaccines were a new technology, healthcare professionals could never have known, for certain, what issues might present in patients.

Based on the incredibly fast and unique method that was used to approve both the vaccines and their manufacturing processes, it was highly possible that even if the basic technology of these novel vaccines was safe, any variety of adverse events might occur as a result of the manufacturing, distribution, handling, or injection of these drugs.

It is unbelievable that healthcare workers would simply dismiss patient claims when considering the dozens of mechanisms and potential issues with these drugs.

Some witnesses reported that when they had experienced an adverse reaction to the injection, their own doctors told them they would not report it as an adverse reaction due to fear of reprisal or ridicule.

Nurse Angela Taylor described how she had experienced a severe reaction to the COVID-19 Injection. Doctors not only refused to report the event but also tried to coerce her into taking a 2nd and 3rd injection.

Kristin Ditzel experienced a severe reaction to the injection within 25 minutes of receiving the shot but was told her reaction was not due to the vaccine..

Healthcare Workers Reporting of Adverse Events

Many physicians testified that they had been prevented from or punished for reporting adverse reactions to the COVID-19 injections.

Dr. Patrick Phillips testified that he had reported five adverse events due to vaccine and the public health officer had rejected all of them, without explanation. A complaint to the regulator against Dr. Phillips was made due to the submission of these adverse event reports. The public health officer did not actually see any of the patients.

Dr. Patrick Provost testified that none of his five vaccine adverse events (VAES) to the mRNA-LPN injection were reported by his treating endocrinologist. One reaction was an exacerbation of his type-1 diabetes that he managed to control himself by fine-tuning his insulin dosing. Not only did his endocrinologist refuse to the report his VAEs, but he also refused to provide him an exemption for his second dose, arguing that the issue with complication of his type-1 diabetes was now under control with proper dosing of insulin.

When Patrick managed to find a healthcare worker who reported his VAEs to the INSPQ (Institut national de santé publique du Québec), he was told by a nurse from the INSPQ, that some of his VAEs were not going to be recorded as they happened six weeks after vaccination, which is the accepted window for traditional vaccines.

Dr. Provost then did a large retrospective analysis of VAEs as monitored by patients‘ modifications to their drug prescriptions. In his study, published in the peer-reviewed journal IJVTPR (International Journal of Vaccine Theory, Practice, and Research) on January 2023, he discovered that the six weeks’ window is too short as 75 per cent of VAEs occurred after six weeks

In a second study published in IJVTPR, based on two cases studies of unreported VAEs, he identified up to 40 obstacles of reporting VAEs properly. He also showed that underreporting of VAEs is really the blind spot of the COVID-19 vaccination campaign. Dr. Provost said that we knew before the COVID-19 vaccination that the underreporting factor was at least 10, but we now realized that it‘s more than 40–100.

Dr. Dion Davidson testified that he had difficulty trying to fill out the online form to report to the adverse events reporting system. He indicated that making a report would take upwards of 45 minutes to do, so most healthcare workers would not do it.

Testimony from first responders detailed that the type of calls for help changed significantly once the vaccines were rolled out to the public and that no reporting of those events as adverse reactions to the COVID-19 injections was carried out.

Dr. Chong Wong testified that he told one of his patients that she should not take any more COVID-19 injections, after she developed blood-clots following the first injection. The patient had been contacted by and told by the public health nurse to take the second shot despite the adverse reaction. The public health nurse had not actually seen the patient or Doctor Wong prior to her giving this advice to the patient.

Dr. Gregory Chan further stated that as of May 2021, he and his colleagues could not use the federal reporting system, so he started to use the Alberta provincial system, Adverse Events Following Immunization (AEFI).

Dr. Gregory Chan testified that he could not navigate the provincial reporting site and could not actually make reports on the website. He finally printed the forms and filled them out manually. He had made 56 reports of adverse reactions due to the COVID-19 injections. He reported that of the 56 reports, he received no acknowledgment from public health on approximately half of them; of the second half of the 56 reports, six were accepted into the system, six were rejected, and nine have not been addressed.

Of the 28 reports acknowledged by Alberta Health, public health advised 16 of them to get the next injection, despite not having actually seen any of these patients.

Dr. Chan reviewed the online criteria systems as set out by Alberta Health and confirmed his 56 reports qualified as adverse reactions as defined by the website.

Dr. Chan further testified that as of May 2021, he and his colleagues could not use the federal reporting system. He reported that five months into the rollout of the vaccines, the CAEFISS system was frustrating as it went from link to link resulting in him having to print off a form to complete by hand.

Dr. Justin Chin testified that both patients and doctors were failing to identify adverse events caused by COVID-19 vaccinations.

Nurse Serena Steven experienced a severe adverse reaction within one hour of receiving the injection, was sent home from the emergency room, and no report of the adverse event was made by medical staff.

Dr. Charles Hoffe noticed significant issues in his patients and sent a private email to 18 of his colleagues questioning if any of them were seeing any of these issues. One of these 18 doctors sent the email to the regional health authorities, who called him in for a meeting; he was told that he was putting patients at risk by questioning the injections.

A complaint was filed with the College of Physicians and Surgeons, and he was told not to discuss any of this with any of his colleagues. He was directed to pose any future questions to the public health officer. Dr. Hoffe noted significant neurological issues in his long-time patients, so he sent a letter to the medical health officer asking for assistance. There was no response, and his letter was forwarded by the public health officer to the College of Physicians and Surgeons as a new complaint against him.

Dr. Hoffe was referred to a vaccine safety specialist who claimed that Dr. Hoffe's observations were incorrect, although she had not seen any of his patients. He was told he should make an adverse reactions report but that these reports would not trigger an investigation.

Dr. Rene Lavigueur testified that if he told the truth about adverse reactions, he was in conflict with public health and at risk of losing his licence. He said he was being forced to simply follow orders. He filled out 16 adverse events reports, but everyone else was too afraid to do it or to even speak about it. He had patients come to him to say their regular doctor had refused to report their adverse events.

Dr. Lavigueur stated that the public health officials were evaluating the reports of COVID-19 vaccine injuries based on checklists that that had been developed with regard to traditional vaccine reactions, failing to understand that COVID-19 injections were not traditional vaccines.

Conclusions

Based on the high level of risk associated with the development, manufacture, and distribution of the novel COVID-19 injections, it was extremely important that any reporting system was designed to collect and examine all reports of alleged vaccine injuries.

Such a system would have to be open to everyone who is affected by the vaccines, including patients, and the system would have to be readily available and easy to interact with.

Healthcare professionals should have been encouraged to report their findings, and all reports should have been entered into the overall system without filtering by frontline staff or public health officials.

The adverse events reporting system, with the exception of the pediatric system, is not only based on a passive reporting model, but healthcare providers were also actively being discouraged from making these reports. Some physicians were reprimanded by their regulators, and others lost their jobs or lost their licence for reporting adverse events.

The system utilized to report adverse events due to COVID-19 injections has failed for a wide range of reasons: some are functional shortcomings in the system; other reasons include willful dismissal of the data and an unwillingness to acknowledge that the initial expectations and analysis were in error. More specifically the problems include:

Underreporting: Like many passive surveillance systems, the adverse event reporting system relies on healthcare professionals voluntarily reporting AEFIs. Underreporting remains a challenge, leading to potential gaps in data and an incomplete understanding of vaccine safety profiles.

Based on the testimony of many witnesses, doctors were actively discouraged and punished for reporting adverse events.

Representativeness: The data collected by the system primarily came from a very limited number of healthcare professionals who had the courage to report. This data cannot be expected to fully capture adverse events experienced by the broader population.

Data Quality and Standardization: Ensuring consistent data collection methods and standardized reporting is essential to improve data quality and comparability. Efforts should be made to streamline data collection and harmonize reporting practices across different sites.

Vaccine Hesitancy and Misinformation: Instead of listening to what doctors and patients were reporting, public health officials decided to categorize many of these injuries as being related to vaccine hesitancy and misinformation, which impacted reporting rates and the overall perception of vaccine safety.

Timeliness: Prompt reporting and analysis of AEFIs are crucial for timely identification and response to potential safety concerns. Ensuring efficient data collection, analysis, and dissemination of findings is needed to address delays and improve the timeliness of vaccine safety monitoring.

Recommendations

To improve the vaccine adverse reactions reporting system, several recommendations must be considered:

A. Enhance Healthcare Provider Education and Awareness:

• Provide comprehensive education and training to healthcare providers on the importance of adverse event reporting, including the recognition and reporting of vaccine-related adverse events.

• Streamline the reporting process to make it more user-friendly and efficient.

• Provide mandatory ongoing education of public health officials to provide insights into the risks associated with novel drug implementation so that they understand the difference between traditional vaccine-type medications and new biologic medications.

• Ensure that on the release of any new drug that all parties involved with the administration or monitoring are fully aware of the actual nature of the drugs under consideration. Some of the shortfalls in the system during COVID-19 had to do with a lack of understanding concerning the nature of these injections.

• Provide re-education for colleges of physicians and surgeons across Canada on the principle behind procedures required and the importance of the adverse event monitoring system.

B. Promote Public Awareness and Engagement:

• Launch public awareness campaigns to educate the general public about the importance of reporting vaccine adverse events.

• Provide accessible information on how and where to report adverse events, emphasizing the role individuals play in vaccine safety monitoring.

• Provide a portal through which patients can directly report their alleged vaccine injuries to the system.

• Encourage vaccine recipients and caregivers to report any adverse events they observe following vaccination.

C. Improve Reporting Infrastructure:

• Develop user-friendly online reporting platforms or mobile applications to simplify and streamline the reporting process for healthcare providers and the public.

• Ensure reporting mechanisms are easily accessible, with clear instructions and options for reporting adverse events, including user-friendly interfaces and multilingual support.

D. Implement Active Surveillance Systems:

• Augment passive surveillance systems with active surveillance components to actively identify and monitor adverse events, especially rare or serious events that may be missed through passive reporting alone.

• Augment passive surveillance systems with active surveillance components to actively identify and monitor patient complaints and trends or patterns of patient complaints following a drug rollout.

• Implement proactive strategies, such as automated electronic health record data mining, to identify potential safety signals and conduct targeted investigations.

E. Strengthen Collaboration and Data Sharing:

• Foster collaboration between different stakeholders, including healthcare providers, public health agencies, vaccine manufacturers, and research institutions, to facilitate seamless data sharing and exchange of information.

• Immediately end the practice of public health officials directly contacting patients and advising them to undertake medical procedures contrary to the attending physician‘s instructions.

• Enhance integration between national and international vaccine safety networks to leverage collective expertise, share best practices, and collaborate on investigations of global vaccine safety concerns.

F. Ensure Timely Analysis and Communication of Findings:

• Prioritize timely analysis of reported adverse events to identify potential safety signals promptly.

• Ensure that those evaluating the data are capable of recognizing and analyzing the data, despite their professional biases.

• Ensure clear and transparent communication of findings to healthcare providers, the public, and other relevant stakeholders, while considering the balance between timely communication and the need for thorough investigation.

G. Continuous Evaluation and Improvement:

• Regularly assess the performance and effectiveness of the reporting system, including feedback from healthcare providers, the public, and other stakeholders, to identify areas for improvement.

• Incorporate advancements in technology and data analytics to enhance the efficiency and accuracy of adverse event reporting and analysis.

By implementing these recommendations, the vaccine adverse reporting system can become more robust, efficient, and responsive, leading to improved vaccine safety monitoring and better protection of public health.