The Italian Medicines Agency has published the fourth Pharmacovigilance Report on COVID-19 vaccines. The data collected and analyzed concern reports of suspected adverse reactions registered in the National Network of
Pharmacovigilance between 27 December 2020 and 26 April 2021 for the four vaccines in use in the current vaccination campaign.
In the period considered, 56,110 reports were received out of a total of 18,148,394 doses administered (report rate of 309 per 100,000 doses), of which 91% refer to non-serious events, which resolve completely, such as injection site pain, fever, asthenia/fatigue, muscle aches. As reported in previous Reports, the reported events mainly occur on the same day of vaccination or the day after (85% of cases).
Serious reports correspond to 8.6% of the total, with a rate of 27 serious events per 100,000 administered doses, regardless of the type of vaccine, the dose (first or second) and the possible causal role of vaccination.
Most of the reports are related to the Comirnaty vaccine (75%), so far the most used in the vaccination campaign (70.9% of the administered doses), and only to a lesser extent to the Vaxzevria vaccine (22%) and to the Moderna vaccine (3%), while there were no reports relating to COVID-19 Janssen vaccine (0.1% of administered doses) in the period considered.
The evaluation of Italian cases of intracranial and atypical venous thrombosis in subjects vaccinated with Vaxzevria is in line with the conclusions of the European Medicines Agency procedure. In Italy, until 26 April 2021, they have been included in the National Pharmacovigilance Network 29 reports of intracranial venous thrombosis and 5 cases of venous thrombosis in an atypical site. Most of these events (22 cases, 65%) involved women with a mean age of about 48 years and only in 1/3 of the cases men (12 cases, 35%) with a mean age of about 52 years. The median time to onset was approximately 8 days after administration of the 1st dose of Vaxzevria vaccine.
The in-depth study of these reports at a national level is conducted with the support of a "Working Group for the assessment of thrombotic risks from anti-COVID-19 vaccines", made up of some of the leading national experts in thrombosis and haemostasis.
The Report can be consulted on the AIFA website on the Pharmacovigilance on COVID-19 vaccines page accessible from the "Correlated links" box
AIFA – Published on: 10 May 2021
