As Canada began to roll out vaccines against COVID-19, the Vaccine Evaluation Center (VEC) supported by UBC and the BC Children’s Hospital Research Institute quickly mobilized to control the safety and side effects of vaccines with the launch of the CANVAS-COVID study.
For Kim Marty, VEC’s senior data manager, one of the biggest challenges was ensuring the success of the study in the face of unprecedented enrollment.
Kim Marty, Senior Data Manager, Vaccine Evaluation Center. Credit: BC Children’s Hospital Research Institute
“This study scaled up very quickly, and we ended up enrolling over 1.8 million participants. No one in the world had ever used the REDCap data platform in the capacity that we did,” he says.
The Vaccine Evaluation Center (VEC) is Canada’s premier academic center for independent vaccine research and an international leader in vaccine research. Marty’s data management team at the VEC helps design study databases and maintain data quality control. They worked more closely than ever with the medical school’s digital solutions team and the BC Children’s Hospital Research Institute IT department to address the technical challenges. They were even in contact with REDCap headquarters at Vanderbilt University in Nashville.
“We ended up merging 70 databases to complete the first phase of the CANVAS-COVID project,” says Marty, noting that the study continues while children aged six months to four years are being vaccinated.
She is proud that her team, with the enthusiastic help of collaborators, has been able to provide weekly safety reports to the Public Health Agency of Canada, the Canadian COVID-19 Immunity Task Force, stakeholders provincial and study researchers, as well as weekly study summaries on the CANVAS-COVID Study Results Web Page.
“This study scaled up very quickly and we ended up enrolling more than 1.8 million participants.” Kim Marty
The study has provided real-time, real-world evidence to show that COVID-19 vaccines are safe, helping to inform public policy decisions and vaccination campaigns. A recent paper by the team, published in The Lancet Infectious Diseases, clearly demonstrated that COVID-19 mRNA vaccines are safe to use during pregnancy, providing much-needed reassurance to worried parents-to-be .
“In the early stages of the COVID-19 vaccine launch, there was low uptake of the vaccine among pregnant women due to concerns about data availability and vaccine safety,” says Dr Manish Sadarangani, director of the VEC and associate professor of pediatrics at UBC. . “This study adds to the growing body of evidence that COVID-19 mRNA vaccines are safe during pregnancy.”
How the previous pandemic prepared the team for COVID-19
The VEC has studied the safety of the flu vaccine every year for the past decade, but those studies include approximately 50,000 participants. That’s less than three percent of current enrollment in the CANVAS-COVID study.
VEC experts had completed preliminary work on a pandemic preparedness plan when COVID-19 struck. The framework of influenza vaccine surveillance studies, pandemic planning, and Marty’s 30 years of data management experience at the VEC helped them move into action.
With so many studies related to COVID-19 starting at the same time, with ever-changing public health guidelines and new developments, it was sometimes overwhelming for Marty’s team.
When it came to monitoring the vaccine’s side effects, the team hoped to have more time. The first COVID-19 vaccine was expected to be approved in June 2021, and then that date kept moving earlier: from April to February, from January to December 2020.
“We thought we had another six months to work on our data management systems,” says Marty, “but then we realized we had to be ready before Christmas. That meant putting in a lot of long hours to be ready in time. The first project was launched on December 23, 2020.”
The hours were similar to those recorded when the H1N1 pandemic, or swine flu, swept into Canada from the southern United States in 2009 with high hospitalization rates in young children.
Marty worked around the clock to ensure that data from half a dozen simultaneous clinical trials of new vaccines could be collected and analyzed quickly to stop swine flu. The processes and procedures she and her team developed remain a core part of the Canadian Immunization Research Network’s pandemic preparedness plan.
In 2019, UBC President Santa Ono cited this H1N1 pandemic work when he presented Marty with the President’s Staff Award for Creativity and Innovation, one of 19 awards given to the more than 16,000 employees of the university
Hard work pays off
Marty says the busy times are worth it because the VEC is a great place to work and values its mission to lead high-quality, independent vaccine research to inform safe, effective and trusted immunization programs for all.
“The research we do is very important, which makes me strive to do it and contribute to knowledge and decision-making.” Kim Marty
“I’m very proud of VEC, the work we do and our approach to being an objective evaluator,” says Marty.
“The research we do is very important, which makes me strive to do it and contribute to knowledge and decision-making.”
The Vaccine Evaluation Center is jointly supported by UBC and the BC Children’s Hospital Research Institute. A version of this story originally appeared on the BCCHR website.