The Italian Medicines Agency (AIFA) today published the 2018 Vaccines Report on the institutional portal, which summarizes the post-marketing surveillance activities on vaccines conducted in Italy in 2018.
Compared to previous reports, this year it was possible, for the calculation of reporting rates (ratio between the number of reports and exposure data), the doses actually administered at national level, provided by the Ministry of Health and the Departments of Prevention of Regions and Autonomous Provinces. This made it possible to calculate the general reporting rates and the serious adverse reactions that could be correlated for doses administered nationwide.
Overall, out of a total of approximately 18 million doses administered in Italy in 2018 for all types of vaccines, 31 reports were made per 100.000 doses, which correspond to approximately 12 reports per 100.000 inhabitants. The reporting rate for correlated serious adverse reactions is 3 events per 100.000 doses. The reported correlable reactions are all known and therefore already reported in the product information of the vaccines authorized in Italy. The growing trend in the number of suspected adverse reactions is indicative of an increasing attention to vaccinovigilance by both health professionals and citizens.
From the analysis of national data, no information emerged that could influence the benefit-risk ratio for the various types of vaccine currently used, thus confirming their safety. In addition to an in-depth analysis of suspected adverse reactions for each type of vaccine, as every year, a focus was dedicated to anti-flu vaccines and some in-depth studies that, in this edition, concern international vaccinations for travelers and the recommended vaccinations in pregnancy.