title: Ongoing pharmacovigilance on vaccines.
abstract: Vaccines have peculiar characteristics as well as their surveillance. Specific requirements, needs and challenges for the vaccine vigilance are discussed in the perspective to improve the whole system in order to guarantee a safer vaccine use and the keeping of the public confidence in vaccinations. Key elements for the routine safety monitoring, new regulations and some available tools are taken into account. Finally, the Italian experience is shortly described.
authors.affiliation: Italian Medicines Agency, Pharmacovigilance Office, Italy. Electronic address: c.santuccio@aifa.gov.it.
authors.forename: Carmela
authors.initials: C
authors.lastname: Santuccio
authors.affiliation: Italian Medicines Agency, Pharmacovigilance Office, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Trotta
authors.affiliation: Italian Medicines Agency, Pharmacovigilance Office, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Felicetti
mesh_terms: D006801:Humans; D007558:Italy; D007880:Legislation, Drug; D060735:Pharmacovigilance; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: AEFI; Pharmacovigilance; Safety monitoring; Vaccine surveillance; Vaccine vigilance; Vaccines