Governance Organization

TOH – The Ottawa Hospital Academic Medical Organization

Project Title

TOH 21 – 001 – Mobile reporting of adverse events from a pandemic COVID-19 vaccine

Project Highlights

Adverse event reporting is a critical component of vaccine programs. The Canadian Vaccine Safety Network conducts surveillance of the seasonal influenza vaccine using a web portal (CANVAS). A mobile app has the opportunity to broaden the reach of this platform. We built an adverse event reporting module into the CANImmunize app and tested it prior to the roll-out of the pandemic vaccine. This project enrolled participants in a randomize control trial to compare the use of the CANImmunize app and the standard CANVAS reporting system for the flu vaccine safety survey. This study was conducted in 2020. Data analysis is ongoing and we plan to submit the manuscript before Christmas. 2485 individuals agreed to participate in the RCT (BC: n=1409, Ottawa n=999). 1196 participants were randomized to the CANVAS arm and 1212 to the CANImmunize arm. 1319 (54%) RCT participants completed their day 8 survey. The response rate was higher among CANVAS users (64%, n=767) compared to CANImmunize users (45%, n=552). Upon completion of the Day 8 survey, participants in both groups were sent a usability survey. 579 participants participated in the useability survey, with 194 CANImmunize and 385 CANVAS respondents, respectively. Ease of use ratings were higher for the CANVAS platform vs. CANImmunize, although usability was acceptable for both groups (strongly agreed or agreed: CANVAS vs. CANImmunize, 99% vs. 79.9%, respectively). CANVAS users agreed more frequently that this system made reporting AEFI easier (CANVAS vs. CANImmunize, 88.8% vs. 75.7% agreed or strongly agreed). Perceived Usefulness When asked about perceived usefulness, 69.9% (CANVAS 73.8%, CANImmunize 61.7%) of respondents thought it will make vaccines safer and 89.4% (CANVAS 91.4%, CANImmunize 85.4%) thought it could make it easier for public health to detect vaccine safety issues. The majority of participants felt it made reporting a vaccine side effect easier (84.5%; CANVAS 88.8%, CANImmunize 75.7%), using this system was a good idea (90.6%, CANVAS 93.2%, CANImmunize 85.3%) and would use it for additional vaccines (84.9%, CANVAS 85.9%, CANImmunize 82.8%) or the COVID-19 vaccine (91.7%, CANVAS 94.0%, CANImmunize 87.0%). Despite this, only 46.2% of participants who completed the survey reported it increased their confidence in vaccine safety (CANVAS 47.4%, CANimmunize 44.1%). Only 71.4% of users felt confident about data privacy and security, and confidence was higher among users of the CANVAS platform (CANVAS vs. CANImmunize: 77.7 vs. 58.5%). Spontaneous reports Spontaneous reports were available for CANImmunize users only. Thirteen participants submitted spontaneous reports, 1 of which was not considered complete. Six reports were for themselves, 7 were for a child. Five participants reported adverse events (n=3 injection site reactions; n=1 injection site reaction, fever, nausea vomiting, unwell, eye swelling, itching and redness, hives; n=1 nasal congestion, eye itching). Two of these were serious enough to miss activities or work, 1 of which was medically attended. The remaining reports did not report an AEFI and we suspect that these participants thought they were submitting their day 8 survey. Summary The data so far suggests that a mobile app platform is not superior to the standard CANVAS reporting platform for participant centered active surveillance. According to the technology acceptance model, technology must be easy to use, and useful in order for it to be accepted. From the users perspective, there appeared to be minimal benefit to using the app and the complexity of use may have made reporting harder. Therefore, we may see limited engagement if this was available publicly. Moving forward, instead of building a separate module into the app we will be building in a link to the CANVAS reporting platform to broaden availability without increasing complexity. This work has been supported by the Canadian Immunity Task Force for use of the 5-11 year old COVID-19 vaccine roll-out.


Virtual Health Care

Primary Project Lead for Contact

Kumanan Wilson


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