The second dose of the AstraZeneca vaccine should not be given in case of thrombosis after the first dose. The clarification of the AIFA, which officially certifies the line to follow, also contains detailed references to the symptoms that must be carefully evaluated.
The AstraZeneca anti-Covid vaccine, recommended in Italy for the over 60s, is “contraindicated in subjects who have presented thrombotic thrombocytopenic syndrome (TTS) following the previous vaccination with Vaxzevria”, specifies the Italian drug agency Aifa, providing ” updates on the points emerging from the risk assessment 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 “.
The vaccine, Aifa recalls, is indicated for active immunization in the prevention of Covid-19, a disease caused by the coronavirus in individuals aged 18 or over. “A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely after vaccination with Vaxzevria”, also underlines the national regulatory body, in an information note addressed to doctors and health professionals, agreed with the authorities European regulations.
“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 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 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 vaccine product name and batch details”.