The Italian Medicines Agency has published the fourteenth Report on the surveillance of anti-COVID-19 vaccines. The data collected and analysed concern reports of suspected adverse reactions recorded in the National Pharmacovigilance Network (RNF) in the two-year vaccination campaign, from 27 December 2020 to 26 December 2022, for the five vaccines in use.

During the period considered, 140,595 reports were received out of a total of 144,354,770 doses administered (reporting rate of 97 per 100,000 doses), of which 81.3% (n. 114,290) referred to non-serious events, such as pain at the injection site, fever, asthenia/tiredness, muscle aches.

Serious reports accounted for 18.7% of the total (n. 26,305), with a rate of 18 serious events per 100,000 doses administered.

During the two years of the vaccination campaign, Comirnaty was the most used vaccine in Italy (66.7%), followed by Spikevax (23.8%), Vaxzevria (8.4%), Jcovden (1.1%) and Nuvaxovid (0.03%). Reports by type of vaccine are distributed as follows: Comirnaty 66.2%, Vaxzevria 17.3%, Spikevax 15.1%, Jcovden 1.3%, Nuvaxovid 0.1%.

For all vaccines, the most reported adverse events, mostly non-serious and already resolved at the time of reporting, are fever, tiredness, headache, muscle/joint pain, pain at the injection site, chills and nausea, with no significant differences between the sexes. An in-depth study is dedicated to gender vaccine surveillance and the analysis by gender of reports of suspected adverse reactions from the anti-COVID-19 vaccine.

No significant changes are observed in the trend of reports related to the paediatric age group (5-16 years).

In consideration of the substantially stable trend of reports and in line with the approach of the various Regulatory Agencies at European level, from now on the data on reports of suspected adverse reactions to anti-COVID-19 vaccines will be included in the Report on post-marketing surveillance of all vaccines, published annually by AIFA.