In 2020, out of a total of about 20 million doses administered in Italy for all types of vaccines, there were 17.9 reports of adverse reaction in every 100,000 administered doses. The reporting rate was equal to 606 reports in every 1,000,000 inhabitants, a sharp decline compared with recent years. Reports of serious vaccine-related reactions were 1.9 in every 100,000 doses.

These data can be found in the 2020 Vaccine Report, published by AIFA. The report describes the vaccine surveillance activities carried out in Italy by the Italian Medicines Agency (AIFA) in collaboration with the Italian National Institute of Health (Istituto Superiore di Sanità) and the Vaccine Signal Analysis Working Group.

The reporting rates (ratio between signals and exposure data) could be calculated thanks to the information on the number of vaccine doses administered in 2020 provided by the Ministry of Health in collaboration with the Regions.

Among the suspected adverse reactions observed in 2020, there were no adverse events that could change the benefit/risk assessment of the vaccines used. All suspected adverse reactions observed are known and had already been reported in the product information of the vaccines authorised in Italy. Moreover, no groupings, temporal or geographical clusters of reports referring to specific batches were observed, suggesting potential quality defects of the medicinal product.

Compared with 2019, a decrease in the reporting rate for administered doses was observed for all vaccines, together with a concurrent reduction in the reporting rates of serious vaccine-related adverse reactions. This trend is likely to be attributed to a lower access to vaccination in 2020 because of the pandemic, which is reflected in a reduced number of administered doses, nearly 3 million less than 2019.

In addition to a detailed analysis of suspected adverse reactions for each single type of vaccine, the Report also contains a detailed overview of vaccination in adolescents and in migrants.

Reports of adverse reactions concerning COVID-19 vaccines are excluded from the scope of this Report since these are covered by dedicated reports already published by AIFA, given that the COVID-19 vaccination campaign was launched on 27 December 2020 with the “Vaccine Day” and officially begun on 31 December 2020.

Published on: 14 March 2022
Last updated on: 15 March 2022