Abstract
Despite the well-recognized role of vaccines, coverage is far from optimal especially in children, representing a growing concern also in Italy. In order to reverse this emergency, the Italian Ministry approved in July 2017 the Law 119/2017, which renders mandatory and free of charge 10 vaccinations for patients aged 0–16. We aim to investigate the effects of the new Law 119/2017 on the reporting of adverse events following immunization related to mandatory vaccines into the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza – RNF). Therefore, we analyzed the spontaneous reports of suspected adverse events following immunization recorded in Campania Region (South of Italy) from December 1, 2016, to March 31, 2018. During the study period, 69 reports, covering 179 AEFIs, related to mandatory vaccines were sent to Campania Pharmacovigilance Regional Center. A substantial increase in AEFIs reporting was observed after the adoption of Law 119/2017. Out of 69 reports, 62% reported AEFIs that were considered as not serious and 78% had a favorable outcome. Out of 179 AEFIs, more than half referred to the following SOC: “general disorders and administration site conditions,” “nervous system disorders,” and “psychiatric disorders.” The highest number of reports came from patient/citizen. After the adoption of the Law 119/2017, there was an increase in the number of reports (18 before the adoption of the Law vs. 51 after). According to reported AEFIs during the entire period, no worrying safety data have emerged. In our opinion, the increase in the number of AEFIs’ reports should be related to the increase in vaccination coverage as well as to the intense debate that has followed the new Law. In this context, the continuous monitoring of vaccine safety and the fully implementation of vaccine–vigilance programs play a key role in achieving higher confidence in immunization programs and optimal vaccination coverage rate.
Highlights
It is worldwide recognized that vaccinations have represented one of the most important breakthrough for global health, leading to significant reductions in mortality and morbidity in the general population (Parretta et al, 2011; Pellegrino et al, 2015; World Health Organization, 2018)
Considering that the rate of ADRs’ reports may increase in response to media attention and increased public awareness (CDC, 2018), we aim to investigate the effects of the new Law 119/2017 on the reporting of AEFIs related to mandatory vaccines into the Italian National Pharmacovigilance Network (Rete Nazionale di Farmacovigilanza, RNF), coordinated by the Italian Medicines Agency (AIFA)
Along with the rapid increase in the coverage for compulsory vaccines registered in Campania Region after the adoption of the Law 119/2017, there was an increase in AEFIs’ reporting
Summary
It is worldwide recognized that vaccinations have represented one of the most important breakthrough for global health, leading to significant reductions in mortality and morbidity in the general population (Parretta et al, 2011; Pellegrino et al, 2015; World Health Organization, 2018). Despite their well-recognized role, coverage for highly recommended vaccines is far from optimal especially in children (Greenwood, 2014; World Health Organization, 2017), representing a growing concern in Italy. According to World Health Organization (WHO), the latter are defined as “any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine” (World Health Organization, 2012)
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