Managing Individual Case Safety Reports (ICSRs) Following COVID-19 Vaccination Campaign

Background/Introduction: Early 2021, the COVID-19 vaccination campaign in the Netherlands started. The Netherlands Pharmacovigilance Centre Lareb had to deal with high volumes of ICSRs, to be processed and assessed in a short time span. This necessitated the development of a dedicated system to enable a near real-time vaccine monitoring. Objective/Aim: To describe the development of an infrastructure which allows processing and assessment of large volumes of ISCRs during the COVID-19 vaccination campaign in the Netherlands. Methods: A specific COVID vaccine web-based reporting form enabled collecting information on the vaccine administered, Adverse Events Following Immunisation (AEFIs) and other information needed for assessment and signal detection. Conditional questions were developed to collect high quality information on specific AEFIs. Preselected fields were mapped to corresponding ICH e2B(R3) fields in the ICSR management system. Where not known and with permission from the reporter, batch numbers were retrieved from the national vaccination registry (CIMS) maintained by RIVM. A fully automatic process for reports enabled handling of the majority of common and known reported AEFIs. All other ICSRs were triaged daily. We arranged a non-priority team that handled reports on most common AEFIs and reports we selected as non-priority; and a high-priority team, consisting of medical doctors and pharmacists with vaccine-expertise, for assessing more complex and also serious reports. The latter team was also responsible for signal detection. Results: Up to June 1st 2021, Lareb received 75.840 ICSRs. This is a reporting rate of approximately 1% of the total amounts of vaccines given in the Netherlands. Fully automatic processing was possible for 48.3% of all received ICSRs on daily basis, making these reports directly available for signal detection. After daily triage of all remaining incoming ICSRs, 4.7% is flagged as a high priority report. The other 47.0% of the non-priority reports could be handled within a few minutes by the assessor. Batch-numbers were added from CIMS in 79% of the retrieval in Q1. With this way of working, we managed processing all ICSRs for signal detection on a daily basis. 99,99% of the serious ICSRs was compliant with a 15 days timeframe for Eudravigilance. The nonserious reports were processed within five weeks (100% compliancy). Conclusion: A new approach which is highly technical supportive enabled to process about 5.000 report