• Vaccini, Magrini (Aifa): "In the summer we will have 30 million doses per month"

  • Aifa: 100 deaths have been reported, one has a connection with vaccine

  • Aifa, serious reactions to the vaccine are 36 out of 100 thousand injected doses

  • Magrini (Aifa): "A necessary break, but nothing changes for us"

  • Covid, PalĂą (Aifa): "With a new government clear change of pace"

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10 May 2021 The Italian Medicines Agency has published the fourth 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 April 2021 for the four vaccines in use in the current vaccination campaign.



In the period considered, Aifa said, 56,110 reports were received out of a total of 18,148,394 doses administered (reporting 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 occur predominantly on the same day of vaccination or the next day (85% of cases).



Serious reports correspond to 8.6% of the total, with a rate of 27 serious events per 100,000 doses administered, regardless of the type of vaccine, the dose (first or second) and the possible causal role of the 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 doses administered), and only to a lesser extent to the Vaxzevria vaccine (22%) and the Moderna vaccine (3 %), while there are no reports of Covid-19 Vaccine Janssen in the period considered (0.1% of the doses administered).



In Italy 34 rare thrombosis cases after Vaxzevria vaccine (formerly AstraZeneca)

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, up to 26 April, 29 reports of intracranial venous thrombosis and 5 cases of atypical venous thrombosis were included in the National Pharmacovigilance Network. Most of these events (22 cases, 65%) involved women with an average age of about 48 years and only in about 1/3 of cases men (12 cases, 35%) with an average age of about 52 years old. The mean time to onset was approximately 8 days after administration of the 1st dose of the Vaxzevria vaccine. The investigation at national level of these reports is conducted with the support of a "Working group for the evaluation of thrombotic risks from anti-Covid-19 vaccines ", made up of some of the leading national experts in thrombosis and haemostasis.


The fourth #AIFA Report on the surveillance of #vaccines # COVID19 is online


👉https: //t.co/Rp7vUztaQw pic.twitter.com/eZjk05Kjgo

- AIFA (@Aifa_official) May 10, 2021