Coronavirus: Second blood clots case likely linked to AZ jab: TGA

The Therapeutic Goods Administration has concluded that a case of blood clots in a WA woman is likely linked to the AstraZeneca vaccine.

The Therapeutic Goods Administration is reviewing all cases of blood clots that have occurred following the AstraZeneca vaccine as a second case of rare thrombosis associated with low platelet count was confirmed in a woman aged in her 40s.

The TGA revealed that its vaccine safety investigation group had concluded the woman’s case was most likely related to the ­AstraZeneca vaccine.

The woman experienced a brain haemorrhage in outback Western Australia and initially was treated in Kununurra Hospital before being transferred to the Royal Darwin Hospital for surgery. She is in a stable condition.

According to medical sources, doctors did not realise until early this month that the woman had received the vaccine two weeks before she experienced cerebral clotting. Her case was then reported to the TGA, which began an investigation.

The new case emerged as US health agencies called for an immediate pause in the use of the Johnson & Johnson single-dose coronavirus vaccine after reports of six cases of blood clots within two weeks of vaccination.

All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalised in critical condition, the officials said.

“Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution,” the FDA said on Twitter.

Seven million people in the US have received the Johnson & Johnson jabs, while nine million more doses have been shipped out to the country.

In Australia, the TGA’s vaccine safety investigation group met on Monday evening and reviewed the woman’s case, with her diagnosis complicated by ambiguous scan and blood test results. “The VSIG meeting reviewed the case in detail, and assessed the case using an internationally accepted method to rate the level of certainty of a link between the event and vaccine,” the TGA said in a statement.

“The panel concluded that the case is similar to cases seen in ­Europe and the United Kingdom of a rare clotting disorder, referred to as thrombosis with thrombocytopenia syndrome, because it ­included significant venous thrombosis (blood clots in the veins), thrombocytopenia (low blood platelet count) and blood test results consistent with other cases of TTS (notably, elevated D-dimer and antibodies to platelet factor 4). Diagnosis was complicated by some ambiguous imaging findings and the need to run additional confirmatory blood tests.”

TGA head John Skerritt said the chance of experiencing the rare blood clotting disorder dubbed vaccine-induced thrombocytopenia and thrombosis remained extremely small in Australia at odds of about one in 350,000.

“That’s an extremely remote and unlikely event,” he said. “It’s a very rare finding. Your chances of winning Lotto are much, much, much higher.”

There have been about 700,000 doses of AstraZeneca vaccine delivered in Australia so far and two cases of VITT. The first occurred in a 44-year-old man on Good Friday. The rate of rare blood clots following the ­AstraZeneca vaccine in Australia is broadly in line with the inter­national experience.

Additional reporting: Jess Malcolm