For Kim Marty, senior data manager at VEC, one of the biggest challenges was ensuring the success of the study in the face of unprecedented enrollment. Kim Marty, senior data manager, Center for Vaccine Evaluation. Credit: BC Children’s Hospital Research Institute “This study was done very quickly and we ended up enrolling over 1.8 million participants. No one in the world had ever used the REDCap data platform to the capacity that we did,” he says. The Vaccine Evaluation Center (VEC) is Canada’s first academic center for independent vaccine research and an international leader in vaccinology research. Marty’s data management team at 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’s IT department to address technical challenges. He was still 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 is ongoing as six-month-olds to four-year-olds are now being vaccinated. She is proud that her team—with the enthusiastic help of her partners—has been able to provide weekly safety reports to the Public Health Service of Canada, the Canadian Immunity Task Force on COVID-19, provincial stakeholders and study investigators, as well as weekly study summaries for the CANVAS-COVID study results website. “This study was done very quickly and we ended up enrolling over 1.8 million participants,” said Kim Marty The study provided real-time, real-time evidence 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 showed that COVID-19 mRNA vaccines are safe for use in pregnancy – providing much-needed reassurance to concerned expectant parents. “In the early stages of the COVID-19 vaccine rollout, there was low vaccine uptake among pregnant women due to concerns about data availability and vaccine safety,” says Dr. Manish Sadarangani, VEC director 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 involve about 50,000 participants. This is less than 3 percent of the current enrollment in the CANVAS-COVID study. VEC experts had completed preliminary work on a pandemic preparedness plan when COVID-19 struck. Context from influenza vaccine surveillance studies, pandemic planning, and Marty’s 30 years of data management experience at VEC helped them spring into action. With so many studies related to COVID-19 starting at once, with ever-changing public health guidelines and new developments, it was sometimes overwhelming for Marty’s team. As for monitoring the vaccine’s side effects, the team expected more time. The first vaccine for COVID-19 was expected to be approved by June 2021, and then this date kept moving earlier – from April, February, 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. This meant putting in long hours to be ready on time. The first project was released on December 23, 2020. The hours were similar to those recorded when the H1N1, or swine flu, pandemic swept across Canada from the southern US in 2009 with high hospitalization rates among 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 procedures and processes she and her team developed remain a key part of the pandemic preparedness plan for the Canadian Immunization Research Network. 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 only 19 awards given to the university’s more than 16,000 employees.
Hard work is worth it
Marty says the hectic times are worth it because the VEC is a great place to work and she values her mission to lead high-quality, independent vaccine research to inform safe, effective and reliable immunization programs for all. “The research we do is very important, which makes me fight to complete it and contribute to knowledge and decision-making,” said Kim Marty “I’m very proud of VEC, the work we do and our approach to being objective evaluators,” says Marty. “The research we do is really important, which makes me fight to complete 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.
