Australia’s drugs regulator has determined the death of a 48-year-old diabetic woman who developed blood clots after receiving the AstraZeneca vaccine was “likely” linked to the jab.
Following a meeting of Australia’s Vaccine Safety Investigation Group on Friday the Therapeutic Goods Administration said experts had concluded the NSW woman’s death four days after receiving the vaccination was likely linked to the jab.
“In the absence of an alternative cause for the clinical syndrome, VSIG believed that a causative link to vaccination should be assumed at this time,” the TGA said in a statement.
The case is the third instance of the rare blood clotting disease linked to the vaccine in Australia but the first death. In its statement, the TGA said the case had been “complicated by the patient’s underlying medical conditions, including diabetes, some other medical conditions as well as some atypical features”.
“In relation to this case, VSIG agreed that the case was consistent with causal association to immunisation although for this patient, anti-PF4 antibodies were absent,” the TGA said.
Anti-PF4 antibodies which activate platelets have been found in almost all other cases reported internationally of blood clots with thrombocytopenia associated with the AstraZeneca vaccine.
The TGA said despite the atypical clinical features and the negative antibody test a causative link to vaccination should be assumed.
Authorities said the woman had received the AstraZeneca vaccine on 8 April, prior to the government’s announcement that the Pfizer vaccine was preferred for patients under 50 years old.
Authorities, including the prime minister, Scott Morrison, had earlier called for people not to jump to conclusions about the case, stressing that clotting events associated with the vaccine remained extremely rare and that the benefits of the vaccine outweighed the risks.
In its Friday night statement, the TGA said there had been at least 885,000 doses of the AstraZeneca vaccine administered in Australia so far, meaning the three cases of rare blood clotting equated to a frequency of one in 295,000 cases.
The UK regulator, the Medicines and Healthcare products Regulatory Agency, has concluded from its review of cases in the UK that the overall risk of the rare blood clots was approximately one in 250,000.
“The TGA is carefully reviewing all Australian reports of blood clots following the AstraZeneca vaccine and are requesting further information from reporters, where needed, to identify any further possible cases of [the clotting disease],” the regulator said.
“The overall number of reports received for blood clots following vaccination so far has been no higher than the expected background rate for the more common type of blood clots in Australia. These can occur in around 50 Australians every day separate to vaccination and are not related to the very rare TTS clotting disorder.”
Earlier this week, the TGA said a second case of a rare blood clot syndrome in Australia was “likely” to be linked to the AstraZeneca vaccine. The case came after a 44-year old Melbourne man also developed the syndrome earlier in April.
The TGA said those first two cases remained in hospital but were recovering well.