Document ID: chunk:federal_register_of_legislation:F2022L00268:reg:6
Version: federal_register_of_legislation:F2022L00268
Segment Type: reg
Provision Reference: reg 6
Character Range: 1540–3928

6               Kind of injury, disease or death to which this Statement of Principles relates
(1)          This Statement of Principles is about vaccine-induced thrombotic thrombocytopaenia and death from vaccine-induced thrombotic thrombocytopaenia.
Meaning of vaccine-induced thrombotic thrombocytopaenia
(2)          For the purposes of this Statement of Principles, vaccine-induced thrombotic thrombocytopaenia means a disorder of coagulation in which there is formation of blood clots in the vascular system in association with a low platelet count, in a person with no exposure to heparin within the previous 30 days.
             Note 1: Vaccine-induced thrombotic thrombocytopaenia (VITT) is also known as vaccine-induced immune thrombotic thrombocytopaenia and thrombosis with thrombocytopaenia syndrome.
             Note 2: Platelet counts are typically below 150,000 per microlitre, but some patients with platelet levels within the normal range may have had, or later will have, a significant drop in platelet levels, or may have the diagnosis confirmed by the presence of other clinical features that are typical of vaccine-induced thrombotic thrombocytopaenia.
             Note 3: Thrombosis often occurs in locations which are unusual for other kinds of thrombotic disorders, including the cerebral venous sinuses, the portal vein and the splenic vein. Patients may concurrently or separately have thrombosis or embolism in more common locations, including venous thromboembolism (for example, deep vein thrombosis and pulmonary thromboembolism) and arterial thromboembolism (for example, acute myocardial infarction and ischaemic cerebrovascular accident).
             Note 4: The diagnosis of vaccine-induced thrombotic thrombocytopaenia is supported by evidence of thrombosis on imaging, elevated D-dimer levels, low fibrinogen levels, detection of antibodies against platelet factor 4–polyanion complexes or detection of platelet-activating antibodies on functional testing.
Death from vaccine-induced thrombotic thrombocytopaenia
(3)          For the purposes of this Statement of Principles, vaccine-induced thrombotic thrombocytopaenia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's vaccine-induced thrombotic thrombocytopaenia.
Note: terminal event is defined in the Schedule 1 – Dictionary.