Enhanced Surveillance of Italian Vaccinovigilance Group During COVID-19 Pandemic: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: The vaccinovigilance Italian group was established since 2014 (1), with members from AIFA, Italian National Institute of Health (ISS), Ministry of Health (MH), Pharmacovigilance Regional Centers (PVRC) and Regional Prevention (RP). Signal detection of vaccines, annual reports on vaccine surveillance and supporting documents for pharmacovigilance activity are the main core of the group activities (2). During pandemic, enhanced surveillance was conducted to better characterize safety profile of the new antiCOVID-19 vaccines. Objective: We reported the enhanced surveillance for anti-COVID19 vaccines, managed by the AIFA in collaboration with ISS, MH, PVRC and RP. Methods: Actions implemented for the enhanced surveillance daily control of the RNF and follow-up requests, periodic publication of reports, interactive graphs on web site updated monthly, meetings of signal detection for anti-COVID-19 vaccines on a monthly basis. Results: From the first month of the vaccination campaign (27/12/ 2020-26/01/2021) a report on the course of safety surveillance was made publicly available (3). Until 26/09/2022 the report was published on a monthly basis, then, considering the downward trend in report submission and the greater knowledge of the vaccine safety profile, we moved to a quarterly frequency. The 10th report is referred to an observation period of one year from the start of the vaccination campaign with 117.920 reports submitted to RNF and 108.530.987 administered doses. In this annual report, there are specific focuses developed with the contribution of the regions, tailored on reproductive health, pediatric population and adverse events of special interest such as anaphylaxis, Guillain Barre syndrome, myocarditis/ pericarditis, Bell paralysis and thrombosis with thrombocytopenia syndrome. The report was presented in live streaming on the AIFA YouTube channel. Regarding the signal detection within the group, it was performed monthly since September 2021;the work was distributed among regions on the basis of vaccines and MedDRA System Organ Class (SOC). As a result of the analysis two signals were validated by AIFA. The signal CLS-Elasomeran was confirmed by the lead member state and determined the update of the Product Information (4). Conclusion: Despite the high number of reports, coordination with the territory and continuous and enhanced surveillance, supported by an integrated group with different expertise (epidemiologist, pharmacist, medical doctors), have proved to be effective in safety monitoring of COVID vaccines.