In 2021, out of a total of approximately 20.5 million doses administered in Italy for all types of vaccines - excluding anti-COVID-19 vaccines - 18,060 reports were entered in the National Pharmacovigilance Network, of which 15,978 refer to suspected adverse events that occurred in 2021, with a rate of 78 reports per 100,000 doses administered. Reports reporting serious vaccine-related reactions were 3.6 per 100,000 doses.

The data are contained in the Report on Vaccines 2021 which describes the vaccine surveillance activities carried out in Italy by the Agency in collaboration with the Istituto Superiore di Sanità and with the Vaccinovigilance Group.

The Report does not include reports on anti-COVID-19 vaccines, which are the subject of dedicated publications.

The number of doses administered in 2021 is comparable to that of the previous year, but an overall increase in the reporting rate per dose administered is observed for all vaccines, attributable to active pharmacovigilance projects promoted by the Regions in collaboration with AIFA.

The contribution of these studies, from which 77.1% of reports come, mainly increased the fraction of reports relating to non-serious events. Even in the presence of greater attention to reporting, the rates of serious reports considered to be correlated to vaccination therefore do not undergo substantial changes compared to previous years and serious adverse events remain known and constant over time.

Among the suspected adverse reactions observed in 2021, no undesirable events emerged that could change the assessment of the benefit-risk ratio of the vaccines used. In fact, these are reactions already reported in the Summary of Product Characteristics and in the Package Leaflet of the vaccines authorised in Italy. Furthermore, no temporal or geographical clustering of reports was observed, worthy of further investigation.

In addition to the detailed analysis of suspected adverse reactions for each type of vaccine, the Report offers in-depth analysis with two focuses dedicated, respectively, to vaccinations in fragile populations and to vaccination against the papilloma virus and screening programmes for HPV-related lesions.