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Did the New Italian Law on Mandatory Vaccines Affect Adverse Event Following Immunization's Reporting? A Pharmacovigilance Study in Southern Italy.


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,

SUBMITTER: Scavone C 

PROVIDER: S-EPMC6131571 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature