• Mon. Oct 25th, 2021

AstraZeneca, Aifa: “In Italy 34 rare thrombosis after vaccine”

Byeditorial

May 10, 2021

In Italy, up to now, 29 reports of intracranial venous thrombosis and 5 cases of atypical venous thrombosis, reported after the administration of the anti-Covid Vaxzevria vaccine by AstraZeneca, have been 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 a third of cases about men (12 cases, 35%) with an average age of about 52 years old. The mean time to onset was approximately 8 days after the first dose was administered. This is what emerges from the fourth Pharmacovigilance Report on Covid-19 vaccines published by the Italian Medicines Agency, relating to reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 April. “The evaluation of the Italian cases of intracranial and atypical venous thrombosis in subjects vaccinated with Vaxzevria – observes Aifa in a note – is in line with the conclusions of the procedure of the European Medicines Agency”. Vaccines and adverse reactions Between 27 December 2020 and 26 April 2021 for the four vaccines in use in the current vaccination campaign, 56,110 reports were received out of a total of 18,148,394 doses administered (with a reporting rate of 309 per 100,000 doses), of which 91% refer to non-serious events, which resolve completely, such as pain at the injection site, fever, asthenia / fatigue, muscle aches. This is what emerges from the fourth Pharmacovigilance Report on Covid-19 vaccines published by the Italian Medicines Agency, relating to reports of suspected adverse reactions registered in the National Pharmacovigilance Network. they occur mostly on the same day of vaccination or the day after (85% of cases). Most of the reports are related to Pfizer / BioNTech’s Comirnaty * vaccine (75%), so far the most used in the vaccination campaign (70.9% of administered doses), and only to a lesser extent to AstraZeneca’s Vaxzevria * vaccine (22 %) and the Moderna vaccine (3%), while there are no reports relating to Covid-19 Vaccine Janssen, J&J (0.1% of the doses administered) in the period considered. recalls Aifa – it 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.