The suspected adverse reactions reported are in line with the information already present in the summary of the product characteristics of the vaccines and the analyzes conducted on the data acquired to date confirm their safety profile.

The Italian Medicines Agency has published the first Pharmacovigilance Report on COVID-19 vaccines, which will take place monthly. The data collected and analyzed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 January 2021 for vaccines in use in the current vaccination campaign: Comirnaty di Pfizer / BioNTech (authorized since 22/12 / 2020 and used from 27/12/2020) and COVID-19 Modern Vaccine (authorized from 07/01/2021 and used from 14/01/2021).

The reports mainly concern the first dose of the Comirnaty vaccine (99%), which was the most used and only to a lesser extent the Moderna vaccine (1%).

In the period considered, 7.337 reports were received out of a total of 1.564.090 doses administered (reporting rate of 469 per 100.000 doses), of which 92,4% referred to non-serious events, such as pain at the injection site, fever, asthenia / fatigue, muscle aches. Headache, paraesthesia, dizziness, drowsiness and taste disturbances were also observed with Comirnaty, while nausea and abdominal pains were observed with the Moderna vaccine.

Less frequent are other local reactions and widespread joint pain. As expected, fever was reported more frequently after the second dose than after the first.

The reported events mostly occur on the same day of vaccination or the day after (85% of cases).

Of the 7,6% of reports classified as "serious", for which the causal link with vaccines is being assessed, three out of four did not require specific intervention in the hospital setting.

During the period, 13 deaths occurred in the hours following vaccination were also reported which, in the more detailed and complete reports of data, were not related to vaccination and are largely attributable to the basic conditions of the vaccinated person.

The analyzes conducted on the data acquired up to now therefore confirm a good safety profile of these two mRNA vaccines. The large number of reports does not imply that unexpected criticalities have emerged, but it is an indication of the high capacity of the pharmacovigilance system to monitor safety.

First AIFA report on the surveillance of COVID-19 vaccines

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