The Impact of Mobile Apps for Spontaneous Reporting: Experience from COVID-19 Vaccines Safety Surveillance

Introduction: Web reporting is mandatory in Europe, but in the surveillance of COVID-19 vaccines specific web forms or apps were developed in several EU member states [1]. In UK for example, a native app for reporting was introduced in 2015. In Germany, a specific native app (SafeVac) was introduced in 2021, associated to an active surveillance project. In both countries a modified web form for covid-19 vaccines is present. In Italy no different web form or app for covid-19 vaccines-AEFI reporting were developed. In the Italian Veneto region, a progressive web app (Vigicovid) was developed and added to the Italian web form (Vigifarmaco) from February 2021. Objective: To investigate the impact of Apps on spontaneous reporting for COVID-19 vaccines in these three countries in 2021. Methods: The reports from UK and Germany in the period JanuaryDecember 2021 were analyzed in VigiBase, the WHO global database of reported potential side effects of medicinal products, developed and maintained by Uppsala Monitoring Centre. Reports from the Apps were identified through the national country code. Reports in Veneto Region were analyzed in the regional database in the period February-December 2021. Reports sent from the Veneto vaccination registry through a direct link to spontaneous reporting database were excluded. Results: In 2021 UK submitted 450,819 AEFIs (56% serious, 85% from patients) to VigiBase, out of which 13,834 (3%) via the App (56% serious). In the same period Germany submitted 176,063 AEFIs (18% serious, 94% from patients) to VigiBase, 13,043 (7%) of which were sent via SafeVac (6% serious). Patients also contributed to Appreporting (86% in the UK vs 85% on the global level and 100% vs 94% on the global level) in UK and Germany, respectively. During the study period February 2021-December 2021 VigiBase received 10,885 (15% serious, 48% from patients) AEFI reports from the Veneto region, 4,568 (42%) of which submitted by App Vigicovid (10% serious) with 2,634 (58%) reports submitted by citizens. Conclusion: The Apps developed in UK and Germany had a limited impact on spontaneous reporting in comparison to the usual reporting (with specific web forms). The progressive web app Vigicovid had a more relevant impact, particularly among citizens.