In our country, vaccinovigilance relies on a solid network that involves the collaboration of various national and regional institutions (such as the Istituto Superiore di Sanità and the Vaccine Signal Analysis Working Group) coordinated by AIFA for the collection of reports of suspected adverse reactions to vaccines and their management in the real context.
Post-marketing monitoring of vaccine safety is of paramount importance: it helps to provide transparent and up-to-date information on vaccine safety and control activities, conducted at global and national level.
The AIFA Vaccines Report aims to describe the vaccine pharmacovigilance activities conducted in Italy on an annual or biennial basis, provides information on the Italian vaccinovigilance system and the pharmacovigilance activities carried out in Italy. This involves the monitoring and evaluation of reports of suspected vaccine reactions, whether spontaneous (passive pharmacovigilance) or prompted by independent studies (active pharmacovigilance).
In 2019, out of more than 23 million doses administered in Italy for all vaccine types, there were only 22 reports of adverse reactions per 100,000 doses and only 2.9 serious reports per 100,000 doses are related to a vaccination. The adverse reactions observed correspond to events already known and therefore already reported in the product information of vaccines authorised in Italy (hyperpyrexia, allergic reactions, etc.).
Reporting rates were calculated from data on the number of vaccine doses administered in 2019 and provided by the Health Prevention Directorate General of the Ministry of Health in cooperation with the Regions.
It is noteworthy that from the analysis of national data no new safety issues have emerged for vaccinesi.e. no information was received that would change the benefit-risk ratio for the various types of vaccines currently used, thus confirming their safety.
In addition to the in-depth analysis of suspected adverse reactions per vaccine type, as every year, the Report devotes a focus to influenza vaccines and offers some insights that, in this edition, concern the 2019/2020 influenza season in Italy, vaccinations in adults and the impact of COVID-19 on routine vaccinations.
Here is the link to download the report
https://www.aifa.gov.it/web/guest/-/rapporto-vaccini-2019
