Expansion of VigiFlow® Network to a Third Level for Post- Marketing Surveillance of COVID-19 Vaccines in Iraq: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: During the COVID-19 vaccines deployment into health institutions (hospitals, primary public health centers (PPHCs));there was a great need to establish a robust pharmacovigilance system to follow the COVID-19 vaccines safety. Integrating both EPI and Iraqi pharmacovigilance center (IPC) systems at different levels to enforce the documentation, share COVID-19 adverse events following immunization (AEFIs), and effectively communicate safety information was crucial. Objective: Describe the steps taken to introduce a third level of the VigiFlow network at the level of hospitals and public health districts (PHDs). Methods: The VigiFlow network was expanded to include not only the 18 regional centers, but also the hospitals where the COVID-19 vaccines were deployed and the PHDs that are connected to the PPHCs. In order to integrate the proposed system for monitoring AEFIs of COVID-19 vaccines;the EPI manager at each Directorate of Health, granted access to the regional center database (VigiFlow). Likewise, national EPI representatives would also have access to the national database at the ministry level (IPC). At the IPC level, the pool of data from all over the country will be available for analysis, signal detection, and decision-making. Induction training program was performed in collaboration with the WHO and EPI. An Arabic manual for using VigiFlow for AEFIs was distributed to users. UMC educational videos on how to use the VigiFlow were translated into Arabic and shared with all participants to facilitate the use of the VigiFlow. A special guideline document was created with simple and comprehensive explanations of the AEFI reporting form(s) and how to transfer the information from the paper form to the VigiFlow system. pharmacovigilance officer at the national center was assigned the mission of supporting all the VigiFlow users across the country. Results: The results showed that 56% of the total COVID-19 vaccine VigiFlow AEFI reports were received through 3rd level VigiFlow organization users. Around 30% were active and sent more than 10 reports per year, representing 33.3% of hospitals and 29% of PHDs. Only 12% of these organizations shared more than 100 reports. The highest number of reports shared in one month was 905 AEFIs reports during August 2021. During December 2021, the highest number of 3rd level VigiFlow organizations sharing AEFIs reports in a single month was 35. Conclusion: The VigiFlow system was successfully used as a national COVID-19 vaccine AEFIs database, with hospitals and public health districts serving as third level.