The fatal blood clotting suffered by a woman in NSW is “likely” linked to the AstraZeneca COVID-19 vaccine she received, Australia’s medical regulator has announced.
The revelation came in a statement late on Friday night from the Therapeutic Goods Administration (TGA).
The TGA’s Vaccine Safety Investigation Group (VSIG) met on Friday and concluded the blood clotting in the 48-year-old woman’s arteries and veins, as well as her low platelet count, was “likely to be linked to vaccination”.
She was vaccinated with the AstraZeneca shot on 8 April and admitted to hospital four days later, where she died.
The review of the woman’s death was complicated by her underlying medical conditions, including diabetes, and “some atypical features”, the TGA’s statement said.
It said “anti-PFA antibodies” – which activate platelets, and have been found in almost all other internationally reported blood clot cases – were also absent.
“Despite the atypical clinical features and the negative antibody test, 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 statement said.
This is the third report of a case of the rare blood clotting disorder linked to the AstraZeneca vaccine in Australia and the first death. The other two cases are being treated in hospital and have been recovering well.
Last Thursday, adults in Australians under the age of 50 were warned off receiving the AstraZeneca shot, with Pfizer becoming the preferred vaccine for that demographic.
The TGA said the woman who died was vaccinated before authorities made the decision later that day, it said in its Friday statement.
Laboratory tests from the woman are still pending and an autopsy will be conducted next week.
“Given this is an atypical presentation, should the test results and autopsy provide an alternative causation, VSIG would review their decision,” the TGA said.
TGA chief John Skerritt said this week that blood clotting associated with the AstraZeneca vaccine was so rare that “your chances of winning the lotto are much higher”, with the regulator’s Friday statement saying the three cases in Australia so far equated to a frequency of one in 295,000.
Earlier on Friday, Chief Medical Officer Paul Kelly urged people to continue to get vaccinated, saying the benefits far outweighed any harm.
He said he had read one unpublished overseas study that suggested COVID-19 brought a risk of blood clotting itself.