AEFIs active surveillance projects as vaccinovigilance traineeship: Puglia (Italy) experience

Abstract

Abstract Surveillance of Adverse Events Following Immunization (AEFIs) is a crucial part of vaccination strategies because the most important concern of “No-vax group” is the safety of vaccination. According to UE laws, in Italy a passive surveillance system of AEFIs is established by law and managed by National Drug Authority (AIFA) and Regional Health Governments. The performance of surveillance system is different in the 21 Italian Regions and in some Region, such as Puglia, the AEFIs reporting rate has been, for several years, lower than National figure. The implementation of AEFIs active surveillance projects could increase the performance of AEFIs surveillance system, also after the end of the project. In Puglia, since 2017, May to 2018, November, an active surveillance of AEFIs has been established, focused on MMRV vaccine. In this study, we analysed the AEFIs general picture in Puglia in 2016 and 2019, before and after active surveillance project. The source of data is the AIFA database; data were reported as number of AEFI and rate for Puglia population (reporting rate RR). The AEFIs were classified as serious, not serious and unclassifiable and causality assessment was performed according to WHO recommendations. The number of AEFIs detected by the passive surveillance system is 91 for 2016 (RR 2,2 per 100.000 people), and 168 for 2019 (RR 4,2 per 100.000 people). The percentage of serious AEFIs was 23.1% (21/91) in 2016 and 31% (52/168) in 2019 and unclassifiable AEFIs were 22% (20/91) in 2016 and 0 in 2019. The percentage of serious AEFIs for which the result of causality assessment was “consistent” is 23,8% (5/21) in 2016 and 55,8% (29/52) in 2019. The experience of AEFIs active surveillance project increase the performance of AEFIs surveillance system. From 2016 (pre-project time) to 2019 (post-project time) the number of AEFIs detected was doubled, the number of unclassifiable AEFIs (proxy of poor reliability of the system) was reduced to zero. Key messages AEFIs passive surveillance system could be affected by underreporting and lack of quality. The AEFIs active surveillance project are an important occasion of traineeship for vaccinovigilance system, that could increase the sensibility and the reliability.