Upgrade of Croatian ADR e-Reporting System for COVID-19 Prospective Cohort Event Monitoring (ACCESS Project): An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: Building on the lessons learnt from 2009 H1N1 pandemic, in order to prepare EU network for monitoring of COVID-19 vaccines, ACCESS project (vACcine Covid-19 monitoring readinESS, VAC4eu.org) was funded in May 2020 by the European Medicines Agency (EMA). It was designed to ensure infrastructure for effective monitoring of COVID-19 vaccines. The Croatian Agency for Medicinal Products and Medical Devices (HALMED) saw this as an opportunity to upgrade existing ADR e-reporting system (OPeN) and set up post-marketing active surveillance of adverse drug reactions (ADRs). Objective: To upgrade existing OPeN system to prospectively collect data about Adverse Events Following Immunisation (AEFIs) against COVID-19 in near real-time. Methods: For the purpose of data collection defined by the ACCESS protocol, OPeN system has been upgraded to incorporate an informed consent, survey tool, survey data report, direct reporting of AEFI reports, when applicable, and their transmission to EudraVigilance.To participate in the study an user account needs to created and consent given. Study participants access the system via the appropriate link. The system is protected by a firewall and Secure Sockets Layer (SSL) protocol. Data protection has been established for both internal and external users. Results: The first phase of the OPeN upgrade started in November 2020 and finished in February 2021. The inclusion of participants in the Croatian study began on 12 February 2021. In the first phase, only healthcare professionals could participate, but the variation in pro- tocol allowed that from April 2021 all vaccinated people could be included. With second phase of upgrade, we were able to include additional questions on relevant medical history, pregnancy, 3rd and booster vaccine dose. 374 vaccinees were recruited in the period from start until the end of April 2022. Almost all vaccinees were adults. Majority were female (77%), and average age was 38 years-old (SD 10, CI ± 1). Total of 303 AEFI reports were collected, of which 97% were non-serious. Conclusion: The OPeN system has shown a wide upgradeability and HALMED was able to establish a system of post-marketing active surveillance in very short time frame as addition to our routine pharmacovigilance activities. However, throughout this process we have identified several issues time consuming multi-step registration process, not enough user friendly interface and insufficient promotion of the OPeN system. Nevertheless, since this was the first time HALMED performed prospective safety monitoring by using a web- based tool we find results encouraging for future activities.