The Italian Medicines Agency has published the ninth Pharmacovigilance Report on COVID-19 vaccines. The data collected and analyzed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 September 2021 for the four vaccines in use in the current vaccination campaign.
In the period considered, 101.110 reports were received out of a total of 84.010.605 doses administered (reporting rate of 120 per 100.000 doses), of which 85,4% referred to non-serious events, such as pain at the injection site, fever , asthenia / fatigue, muscle aches.
Serious reports correspond to 14,4% of the total, with a rate of 17 serious events per 100.000 doses administered. As reported in previous Reports, regardless of the vaccine, dose and type of event, the reaction occurred in most cases (about 76%) on the same day of vaccination or the next day and only more rarely beyond 48 hours. .
Comirnaty is currently the most used vaccine in the Italian vaccination campaign (71,2%), followed by Vaxzevria (14,5%), Spikevax (12,5%) and COVID-19 Vaccino Janssen (1,8%). In line with previous Reports, the distribution of reports by type of vaccine is similar to that of administrations (Comirnaty 68%, Vaxzevria 22%, Spikevax 9%, COVID-19 vaccine Janssen 1%).
For all vaccines, the most reported adverse events are fever, fatigue, headache, muscle / joint pain, local reaction or pain at the injection site, chills and nausea.
In relation to the so-called heterologous vaccinations to people under 60 who had received Vaxzevria as the first dose, 262 reports were received, out of a total of 644.428 administrations (the second dose concerned Comirnaty in 76% of cases and Spikevax in 24%) , with a reporting rate of 40 for every 100.000 doses administered.
In the age group between 12 and 19 years, as of 26/09/2021, 1.358 reports of suspected adverse event were received out of a total of 5.623.932 doses administered, with a reporting rate of 24 adverse events per 100.000 doses administered. The distribution by type of adverse events is not substantially different from that observed for all other age groups.
With regard to the administration of the third dose, which began in September, only one report was made, compared to approximately 46.000 doses administered.
Given the stability of the reporting trend for the various COVID-19 vaccines, the Surveillance Report will no longer be published monthly but rather quarterly. On the other hand, the interactive graphs available on the AIFA website remain monthly.