Canadian researchers studying effectiveness, safety of COVID-19 vaccines during pregnancy

The Government of Canada, through its COVID-19 Immunity Task Force (CITF) and Vaccine Surveillance Reference Group (VSRG), is investing approximately $1.3 million for two Canadian research teams to further evaluate vaccine safety and effectiveness in pregnant people. While pregnant or breastfeeding individuals were excluded from the initial mRNA and viral vector COVID-19 clinical trials, recent real-world evidence is showing that mRNA COVID-19 vaccines are safe during pregnancy. Additional research and surveillance of COVID-19 vaccination among pregnant and lactating populations is needed.

Results will be communicated regularly to public health officials to help inform decision making for ongoing COVID-19 vaccine administration programs in Canada. Individuals from anywhere in Canada who are currently pregnant or breastfeeding are invited to register to take part in the COVERED vaccine study. Participants do not have to have already received a COVID-19 vaccine, nor do they need to intend to receive the vaccine.

Researchers in British Columbia are launching a COVID-19 vaccine registry for pregnant and breastfeeding people across Canada called COVERED.

“We are asking pregnant and breastfeeding individuals in all 10 provinces and three territories to sign-up for the registry, after which they will be invited to fill out a survey,” says study lead researcher Dr. Deborah Money, Professor in the Department of Obstetrics and Gynecology at the University of British Columbia. “Through this registry and survey, we will monitor the safety of the various vaccines for those who are pregnant and breastfeeding. We will also study whether the vaccines are more effective – or less so – in this group. It is important that these data become available to pregnant and breastfeeding individuals so that they are able to make an informed choice about getting a COVID-19 vaccine.”

This project is being conducted in partnership with vaccine surveillance efforts across Canada, including the Canadian Vaccine Safety Network (CANVAS), a national platform which assesses vaccine safety during the implementation of vaccine campaigns across Canada.

This second study will link information collected from the Better Outcomes Registry & Network (BORN) Ontario Registry, which collects data from every baby born in Ontario, with the province’s vaccination registry from the Ontario Ministry of Health (COVaxON).

• This study will link information from the BORN Ontario Birth Registry, in which every baby born in Ontario is registered, with the province’s vaccination registry from the Ontario Ministry of Health (COVaxON).

• Researchers will monitor the health outcomes of mothers and their babies, comparing individuals who received a COVID-19 vaccine during pregnancy, or just before, with those who did not.

• The study will also assess the effectiveness of COVID-19 vaccination during pregnancy by looking at the number of people who subsequently get a lab-confirmed COVID-19 infection.

• Although the early evidence to date on COVID-19 vaccination in pregnant populations has not identified any safety concerns, it is critically important to monitor the health of mothers and babies following COVID-19 vaccination during pregnancy during this public health emergency. The findings from this study will help to fully inform pregnant people, their care providers, and public health policymakers.

“We will be monitoring the health of mothers and their babies, comparing individuals who received a COVID-19 vaccine during pregnancy, or just before, with those who did not,” explains study lead researcher Dr. Deshayne Fell, Scientist at the CHEO Research Institute and Associate Professor at the University of Ottawa. “We will also assess the effectiveness of COVID-19 vaccination during pregnancy by looking at the number of people who have been infected by SARS-COV-2, the virus that causes COVID-19.”

“Although early evidence to date on COVID-19 vaccination in pregnant populations has not identified any safety concerns, it is critically important to monitor the health of these individuals and their babies following COVID-19 vaccination,” says Dr. Scott Halperin, Co-Chair of the VSRG and Principal Investigator of the Canadian Research Immunization Network (CIRN). “The findings from this study will help to inform pregnant individuals, their care providers and public health policy-makers.”

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The Better Outcomes Registry & Network (BORN) Ontario is the province’s pregnancy, birth and childhood registry and network. By collecting, interpreting, sharing and rigorously protecting critical data about every birth in the province, BORN Ontario makes a positive and lasting contribution to the health of mothers, newborns, children and the citizens of Ontario. BORN Ontario is a provincial program of CHEO, a pediatric health and research centre based in Ottawa. http://www.bornontario.ca

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 PHAC and is supported by the CITF Secretariat. It is co-chaired by the leaders of NACI and 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/

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: http://www.covid19immunitytaskforce.ca