The official stop arrives. The vaccine anti-Covid in AstraZeneca it is «contraindicated in subjects who have presented thrombotic thrombocytopenic syndrome (TTS) following previous vaccination with Vaxzevria». This was specified by the Italian Medicines Agency Aifa, providing “updates on the points that emerged from the assessment of the risk 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 ( for example, hematologists, coagulation specialists) to diagnose and treat this condition “.
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Still, «subjects diagnosed with thrombocytopenia arising within 3 weeks of vaccination with Vaxzevria – adds Aifa – must be actively evaluated for signs of thrombosis. Likewise, subjects who present with thrombosis within 3 weeks of vaccination should 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 il 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 manifestation includes severe cases presenting as venous thrombosis, even at unusual sites of onset, such as the thrombosis cerebral venous sinus thrombosis and splanchnic venous thrombosis, as well as arterial thrombosis in conjunction with thrombocytopenia. Some cases have had a fatal outcome. Most of these cases occurred in the first 3 weeks after vaccination and mainly occurred in women under the age of 60 ».
“Healthcare professionals must 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 convulsions after vaccination or bruising (petechia) in a site other than that of the vaccination after a few days, should immediately consult a doctor. “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”.