Canada Special Immunization Clinic Network Mobilized in $800K Study to Track COVID-19 Vaccine Adverse Events

Canada Special Immunization Clinic Network Mobilized in $800K Study to Track COVID-19 Vaccine Adverse Events

The Canadian government’s COVID-19 Immunity Task Force (CITF) and Vaccine Surveillance Reference Group (VSRG) announced an $800,000 investment as part of a quest to better understand how to improve Canada’s identification and response to the adverse events people may experience following COVID-19 vaccination across 10 provinces. This is an extension of an existing vaccine safety initiative that was set up to offer public health information about adverse events following immunization for all vaccines authorized for use in adults and children in the nation. The funding propels a study forward, allowing a more methodical and systematic tracking of adverse events associated with the COVID-19 vaccines authorized in Canada. TrialSite applauds the effort.

Recognition of Problems

Although it may not seem like big news, this announcement is tacit recognition of mounting safety reports associated with vaccines that at least in America, are still considered investigational—that is, they are not formally approved or registered but authorized under emergency use in the nation to the south. 

In Canada, Dr. Karina Top, Principal Investigator (PI) for this initiative as well as lead investigator of the Canadian Immunization Research Network’s (CIRN) Special Immunization Clinic (SIC) Network, which conducts the study, commented, “While the benefits of the COVID-19 vaccination continue to outweigh the risks, when a patient develops an unexpected or serious adverse event that requires medical attention, it is important we determine the possible role of the vaccine and the safety of giving future vaccine doses to this specific person or to people with similar adverse events.”

Dr. Top continued, “We will share our results with public health authorities and healthcare providers to help them address possible safety concerns and inform COVID-19 vaccine recommendations for people who have had an adverse event.”

The results of this research will be reported on a regular basis to federal and provincial/territorial public health authorities and advisory committees.

Careful Language

The pressure to vaccinate everyone over 12 is fierce and the social, collectivist group think that results, prodded by a confluence of government, industry, and academic, can blur clear and concise thinking on important matters. Of course, it makes sense to have a surveillance study like this—it’s to be applauded. But the investigators involved must be mindful of each and every word uttered.

Dr. Scott Halperin, the Vaccine Surveillance Reference Group (VSRG) Co-Chair, is a case in point. He also serves as co-investigator on this study and PI of CIRN. Dr. Halperin declared, “The COVID-19 vaccines authorized by Health Canada have been incredibly safe, especially considering the millions of people worldwide who have received a vaccine and the small number of adverse events to date.” He continued, “That said, vaccine safety surveillance is extremely important. We must systematically document and follow up with patients who experience a medically significant or unexpected adverse event. This information is needed to ensure patients receive appropriate care and recommendations on future vaccinations. The findings also help public health officials make important decisions regarding vaccines, when necessary.“ The point is, if there wasn’t an issue then this study probably wouldn’t be necessary. 

Dr. Alice Aiken, serving Dalhousie University as Vice President Research and Innovation went on the record, “There has never been a more critical time to collect real-time evidence to inform practice, policy and decision making.”  She went on to praise Dr. Top for her important work.

The SIC Network

The SIC Network was established in 2013, and now has 17 sites covering 10 provinces. The network also has international links to align with international standards, and to incorporate global evidence into the Canadian context. To be included in the study, patients who experience an adverse event following COVID-19 vaccination can be referred to the SIC Network by a healthcare provider for further assessment. This may include a detailed medical history, additional investigations such as allergy skin testing, and treatment such as supervised re-vaccination for any allergic reactions. The SIC Network may also coordinate referrals to other specialists to help confirm the diagnosis.

About the Canadian Immunization Research Network (CIRN)

The Canadian Immunization Research Network (CIRN) is a national network of key vaccine researchers who develop, and test methodologies related to the evaluation of vaccines as they pertain to safety, immunogenicity and effectiveness, and program implementation and evaluation. CIRN’s objective is to further strengthen Canada’s research capacity, evidence base and expertise in the field of immunization and vaccines for vaccine-preventable diseases. A ‘network of networks,’ CIRN plays a pivotal role in mentoring early-career researchers, recruiting new investigators, providing opportunities for trainees, and delivering meaningful engagement of stakeholders at all research stages.

CIRN is made up of the following 8 networks: the Canadian National Vaccine Safety Network (CANVAS); the Clinical Trials Network (CTN); the Serious Outcomes Surveillance Network (SOS); the Special Immunization Clinic Network (SIC); the Provincial Collaborative Network (PCN); the Social Sciences and Humanities Network (SSHN); the Modeling and Economics Research Network (ModERN); and the Reference Laboratory Network (RLN).

The SIC Network was established in 2013 to standardize and improve the care of patients with adverse events following immunization and determine the risks of an adverse event recurring with future vaccinations.

About Dalhousie University

Dalhousie University is Atlantic Canada’s leading research-intensive university. Located in the heart of Halifax, Nova Scotia, with an Agricultural Campus in Truro/Bible Hill, Dalhousie is a truly national and international university, with more than half of the university’s 20,000-plus students coming from outside the province. Dal’s 6,000 faculty and staff foster a diverse, purpose-driven community, one that spans 13 faculties and conducts more than $194 million in research annually. Part of a cluster identified as one of the world’s top international centers in ocean research, the university proudly celebrated its 200th anniversary in 2018.

About the Vaccine Surveillance Reference Group (VSRG)

The Vaccine Surveillance Reference Group (VSRG) supports the monitoring of the safety and effectiveness of COVID-19 vaccines in Canada. It is a consortium of Canadian organizations – the Public Health Agency of Canada (PHAC), the Canadian Research Immunization Network (CIRN), the National Advisory Committee on Immunization (NACI), and the COVID-19 Immunity Task Force (CITF) – working collaboratively to pool expertise on vaccine surveillance. The VSRG reports to the Public Health Agency of Canada (PHAC) and is supported by the COVID-19 Immunity Task Force (CITF) Secretariat. It is co-chaired by the leaders of the National Advisory Committee on Immunization (NACI) and the Canadian Immunization Research Network (CIRN). Among its responsibilities, the VSRG, through the CITF Executive Committee, makes recommendations to PHAC on funding research teams that can address important aspects of the immune response, safety, and effectiveness of COVID-19 vaccines with public health relevance and with attention to all priority groups. For more information visit: covid19immunitytaskforce.ca/vaccine-surveillance-reference-group-vsrg/

About the COVID Immunity Task Force (CITF)

The Government of Canada established the COVID-19 Immunity Task Force in late April 2020. The Task Force is overseen by a Leadership Group of volunteers that includes leading Canadian scientists and experts from universities and healthcare facilities across Canada who are focused on understanding the nature of immunity arising from the novel coronavirus that causes COVID-19. To that end, the CITF is supporting numerous studies to determine the extent of SARS-CoV-2 infection in Canada (in the general population as well as in specific communities and priority populations), understand the nature of immunity following infection, develop improved antibody testing methods, and help monitor the effectiveness and safety of vaccines as they are rolled out across Canada. The Task Force and its Secretariat work closely with a range of partners, including governments, public health agencies, institutions, health organizations, research teams, other task forces, and engage communities and stakeholders. Most recently, the Task Force has been asked to support vaccine surveillance, effectiveness and safety as part of its overall objective to generate data and ideas that inform interventions aimed at slowing—and ultimately stopping—the spread of SARS-CoV-2 in Canada. For more information visit: www.covid19immunitytaskforce.ca

Lead Research/Investigator

Dr. Karina Top, Principal Investigator (PI) for this initiative as well as lead investigator of the Canadian Immunization Research Network’s (CIRN) Special Immunization Clinic (SIC) Network, Associate Professor, Department of Pediatrics and Community Health and Epidemiology, Dalhousie University, Investigator at Canadian Center for Vaccinology

Call to Action: Want to refer a patient in Canada to this network—visit https://cirnetwork.ca/sic-network-patient-referrals/ to find the site closest to you. In addition, for information on reports of side effects following COVID-19 vaccination, refer to https://health-infobase.canada.ca/covid-19/vaccine-safety/summary.html.

Responses

  1. COVID-19 vaccines and Aviation Medical Certificate holders
    Date modified: 2020-12-10 – While Transport Canada Civil Aviation Medicine [TC CAM] places no restrictions or limitations on vaccines [experimental COVID-19 vaccines would surely constitute medical trials] approved by Health Canada, it remains the general position of TC CAM that participation in medical trials is not considered compatible with aviation medical certification [needed to validate pilot’s (aviation) licenses].
    https://tc.canada.ca/en/aviation/medical-fitness-aviation/covid-19-vaccines-aviation-medical-certificate-holders

    March 25, 2021 – See: AIR-AIRMANSHIP – Paragraph 3.13 Immunization https://tc.canada.ca/sites/default/files/2021-03/aim_2021-1_access_e.pdf

    August 31, 2020 – “The Prime Minister, Justin Trudeau, today announced that agreements to procure millions of doses of experimental COVID‑19 vaccines.”
    https://pm.gc.ca/en/news/news-releases/2020/08/31/new-measures-ensure-supply-future-vaccines-and-therapies-against

    The ‘experimental COVID-19 vaccines’ were first administered to the Canadian public (TORONTO & QUEBEC), on Monday, December 14, 2020

    [mine] EMPHASIS supplied

  2. Good luck… We attempted to report an adverse event in Ontario, Canada. We called the clinic we typically go to, none of the nurses or the doctor there even knew the tracking system existed. We then called the public health unit, again, the person that answered the phone had no idea what we were talking about. It was as if all of these people were bewildered at the notion of adverse events even happening from a vaccine… Finally, after being transferred 2 or 3 times, we managed to get to a woman who at least was aware of the system. She said she would note our adverse event in her personal notes… and if she, personally, noticed a pattern, she may submit it to the tracking system.

    In case anyone is wondering why our system in Canada is so grossly underused and underreporting, presumably, this is why. Along with the incredible downward pressure by government and media to even admit there are adverse events.