EMA has just published the new product information leaflet for Astrazeneca Covid-19 vaccine after investigations of thrombosis rare cases reported.
In the section 4.4 Special warnings and precautions for use has been added the following:
Thrombocytopenia and coagulation disorders
A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has
been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. This includes
severe cases presenting as venous thrombosis, including unusual sites such as cerebral venous sinus
thrombosis, mesenteric vein thrombosis, as well as arterial thrombosis, concomitant with thrombocytopenia.
The majority of these cases occurred within the first seven to fourteen days following vaccination and occurred in women under 55 years of age, however this may reflect the increased use of the vaccine in this population. Some cases had a fatal outcome.
Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or
thrombocytopenia. Those vaccinated should be instructed to seek immediate medical attention if they
develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain
following vaccination. Additionally, anyone with neurological symptoms including severe or
persistent headaches or blurred vision after vaccination, or who experiences skin bruising (petechia)
beyond the site of vaccination after a few days, should seek prompt medical attention.
It must be noted that no linking has been correctly introduced about contraceptive pill usage.
For Dr. Pier Maria Fornasari thrombocytopenia is the result of thrombi platelet consumption and the clinical picture resembles Trombotic Thrombocytopenic Purpura, where a congenital defect of ADAMTS13 enzyme is present. A congenital defect of ADAMTS13 is concetrated in Norway as recently published.
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