Canadian researchers to study best approaches to possible adverse events following COVID-19 vaccination

The Government of Canada, through its COVID-19 Immunity Task Force (CITF) and Vaccine Surveillance Reference Group (VSRG), is investing approximately $800,000 for a study that aims to further improve Canada’s identification and response to adverse events people may experience following COVID-19 vaccination across 10 provinces. This study is an extension of an existing vaccine safety program that provides important public health information about adverse events following immunization (AEFI) for all vaccines authorized for use in adults and children.

“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,” explains Dr. Karina Top, Principal Investigator (PI) of the project and lead investigator of the Canadian Immunization Research Network’s (CIRN) Special Immunization Clinic (SIC) Network, which is conducting the study. Dr. Top is also an Associate Professor in the Department of Pediatrics and Community Health and Epidemiology at Dalhousie University and an investigator at the Canadian Center for Vaccinology.

“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,” explains Dr. Top.

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.

“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,” says VSRG Co-Chair Dr. Scott Halperin, who is also a co-investigator on the study and PI of CIRN. “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.”

“There has never been a more critical time to collect real-time evidence to inform practice, policy, and decision making,” says Dr. Alice Aiken, Vice President Research and Innovation at Dalhousie University. “We are very proud of Dr. Karina Top and the important work she is doing to ensure that the vaccines we are using are safe and effective, and to help stop the spread of COVID-19.”

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

If you are a physician looking to refer a patient, please 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.

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 centres 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 engages 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

Media contacts:
To speak to one of the study researchers:
Olivia Kwiecien
Program Communications, Canadian Immunization Research Network (CIRN)
Oliviam.kwiecien@iwk.nshealth.ca

To speak to a member of the CITF/VSRG:
media@covid19immunitytaskforce.ca
Rebecca Burns, Cell: +1.438.871.8763
Caroline Phaneuf, Cell: +1.514.444.4532