Ongoing pharmacovigilance on vaccines

Carmela Santuccio; Francesco Trotta; Patrizia Felicetti

doi:10.1016/j.phrs.2014.10.011

Ongoing pharmacovigilance on vaccines

Pharmacol Res. 2015 Feb:92:2-5. doi: 10.1016/j.phrs.2014.10.011. Epub 2014 Nov 10.

Authors

Carmela Santuccio¹, Francesco Trotta², Patrizia Felicetti²

Affiliations

¹ Italian Medicines Agency, Pharmacovigilance Office, Italy. Electronic address: c.santuccio@aifa.gov.it.
² Italian Medicines Agency, Pharmacovigilance Office, Italy.

PMID: 25447592
DOI: 10.1016/j.phrs.2014.10.011

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.

Keywords: AEFI; Pharmacovigilance; Safety monitoring; Vaccine surveillance; Vaccine vigilance; Vaccines.

Publication types

Review

MeSH terms

Humans
Italy
Legislation, Drug
Pharmacovigilance
Vaccines / adverse effects*

Substances

Vaccines