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Third death linked to AstraZeneca
The recent death of a 61-year-old WA woman was likely linked to the vaccine, TGA confirms: ‘Lack of strong evidence for other causes.’
A total of 76 cases of thrombocytopenia syndrome have so far been detected in five million doses of AstraZeneca in Australia. (Image: AAP)
The Therapeutic Goods Administration (TGA) is closely monitoring reports of immune thrombocytopenic purpura (ITP) following the June death of a woman in Western Australia after she received the AstraZeneca COVID vaccine.
‘An external vaccine safety investigation group (VSIG) of clinical experts and consumer representatives, convened on 2 July 2021, concluded that the woman’s death was likely linked to the vaccine,’ the TGA announced in its latest weekly safety report.
‘This was based on the lack of strong evidence for other causes and the occurrence of the event being within a plausible time period after vaccination.’
While the woman had experienced a recent viral illness that ‘could have theoretically caused ITP’, it was determined the ‘unusual severity’ of the event made the vaccine the most likely cause.
ITP causes low blood platelet levels. It is described as ‘a rare autoimmune disorder in which a person’s blood doesn’t clot properly because the immune system destroys the blood-clotting platelets’.
While the association between ITP and AstraZeneca is still being investigated, the TGA said preliminary findings from a recent Scottish study estimate the risk of the disorder to be about one case per 100,000 doses of the vaccine.
‘To 4 July 2021, the TGA has received 36 reports of suspected ITP,’ the regulator said. ‘The TGA continues to investigate this issue and we will report more information when it is known.’
Elsewhere in the safety report, the TGA said seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia syndrome (TTS) likely linked to AstraZeneca.
‘This brings the total number of cases of TTS to 76 out of five million doses to date,’ the TGA said.
The regulator also reported an average of 4.4 adverse events per 1000 doses of vaccines – AstraZeneca and Pfizer – to 4 July. The most common side effects are ‘are predictable and have been observed with vaccines generally’, and include headache, muscle pain, fever, chills, nausea and injection-site reactions.
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