Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Dec 10, 2020
Date Accepted: Mar 12, 2021
Post-Marketing Safety Monitoring of Vaccines Using a Mobile Health App: Feasibility in the Case of Influenza Immunization
ABSTRACT
Background:
For the safety monitoring of vaccinations post-licensure, reports of adverse events after immunization (AEFI) are crucial. New technologies, such as digital mobile appslications (apps) can be used as an active approach to capture these events. We therefore conducted a feasibility study among recipients of influenza vaccination using an app for assessment of the reporting of adverse events after immunization. Objectives To determine factors influencing the adherence, correct usage of a specific newly developed app for individuals to report adverse events following immunization for three months using regular reminder functions and to identify determinants for AEFI occurrence and define reported AEFI types. Methods We developed the app (SafeVac) and offered it to recipients of influenza vaccination in three occupational settings in fall 2018. In this prospective longitudinal feasibility study, data on AEFI were generated through SafeVac for three months. Using logistic and Cox regression, we assessed associations between app–-adherence, correct app–-entry, AEFI and sociodemographic parameters.
Objective:
To determine factors influencing the adherence, correct usage of a specific newly developed app for individuals to report adverse events following immunization for three months using regular reminder functions and to identify determinants for AEFI occurrence and define reported AEFI types.
Methods:
We developed the app (SafeVac) and offered it to recipients of influenza vaccination in three occupational settings in fall 2018. In this prospective longitudinal feasibility study, data on AEFI were generated through SafeVac for three months. Using logistic and Cox regression, we assessed associations between app–-adherence, correct app–-entry, AEFI and sociodemographic parameters.
Results:
Of 337 individuals, who logged into SafeVac 207 (61%) used the app throughout three–month period. App–usage adherence was negatively associated with female sex (OR: 0.47; CI: 0.25, 0.91) and correct app–entry was negatively associated with older age (OR :0.96, CI: 0.93; 0.99) and lower education (OR: 0.31, CI: 0.13; 0.76). AEFI occurrence was associated with female sex (OR: 1.41, CI: 1.01, 1.96) and negatively with older age (OR: 0.98, CI: 0.97, 0.99). The most common AEFI reported were injection site pain (106/337), pain in extremity (103/337), fatigue/asthenia (73/337).
Conclusions:
Digital AEFI reporting was feasible with SafeVac and generated plausible results for this observation period and setting. Studies directly comparing SafeVac with conventional passive reporting schemes could determine whether such digital approaches improve completeness, timeliness and sensitivity of vaccine vigilance. Further studies have to evaluate if these results are transferable to other vaccinations and populations and if an introduction of such a tool have influence on vaccination readiness and therefore vaccine safety.
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