Covid: Aifa, no AstraZeneca vaccine in case of rare thrombosis after first dose

Milan, June 3 (beraking latest news Salute) – AstraZeneca’s anti-Covid vaccine is “contraindicated in individuals who have experienced thrombotic thrombocytopenic syndrome (TTS) following previous vaccination with Vaxzevria *”. This was specified by the Italian drug agency Aifa, providing “updates on the points that emerged from the assessment of the risk of onset of thrombosis in combination with thrombocytopenia”.

“TTS requires specialized clinical management – underlines the national regulatory body, in an Information Note addressed to doctors and health professionals, agreed with the European regulatory authorities – Health professionals must consult the applicable guidelines and / or consult specialists ( eg, hematologists, coagulation specialists) to diagnose and treat this condition “. Furthermore, “subjects diagnosed with thrombocytopenia within 3 weeks of vaccination with Vaxzevria – adds Aifa – must be actively evaluated for signs of thrombosis. Similarly, subjects who present thrombosis within 3 weeks of vaccination must be evaluated for thrombocytopenia “.

“Vaxzevria is indicated for active immunization in the prevention of Covid-19, a disease caused by the Sars-CoV-2 virus, in subjects aged 18 or over – reads the information with which Aifa has updated the AstraZeneca Covid Vaccine Summary of Product Characteristics (CPR) – A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely after vaccination with Vaxzevria. This includes severe cases presenting as venous thrombosis, including at unusual sites of onset, such as cerebral venous sinus thrombosis and splanchnic venous thrombosis, as well as arterial thrombosis in conjunction with thrombocytopenia. Some cases have been fatal. Most of these cases have occurred in the first 3 weeks following vaccination and mainly occurred in women under the age of 60 “.

“Healthcare professionals should pay attention to the signs and symptoms of thromboembolism and / or thrombocytopenia – recommends the agency – Vaccinated subjects should be instructed to consult a doctor immediately if they develop symptoms such as shortness of breath, chest pain, leg swelling, pain in the legs, persistent abdominal pain after vaccination. In addition, anyone who experiences neurological symptoms including severe or persistent headache, blurred vision, confusion or seizures after vaccination, or bruising (petechia) at a different site from the vaccination site after a few days, should consult a doctor immediately “.

“Healthcare professionals must report any suspected adverse reactions associated with the use of Vaxzevria in accordance with the national spontaneous reporting system”, concludes Aifa, highlighting “the importance of reporting the name of the vaccine product and the details of the batch”.