The Therapeutic Goods Administration has announced it is investigating a potential link between the AstraZeneca vaccine and a rare clotting disorder, after a 44-year-old man was admitted to hospital with blood clots after receiving the vaccine.
On Friday Australia’s acting chief medical officer, Prof Michael Kidd, told reporters that health authorities were taking this case “very seriously”.
“One case of this clotting disorder has been recorded in Australia overnight and we are taking this very seriously.
“It is currently being investigated by the Therapeutic Goods Administration and a meeting will be held tomorrow of the TGA vaccine safety investigation group, which will examine this report and determine whether it could be linked to the AstraZeneca vaccine.”
The man received the vaccine on 22 March and days later he presented at Melbourne’s Box Hill hospital suffering from a fever and abdominal pain. He was found to have abdominal clots with a low platelet count.
Although authorities are concerned at the developments, Kidd maintained that there was still no confirmed link between the vaccine and the blood clotting.
“Investigators have not at this time confirmed a causal link with the Covid-19 AstraZeneca vaccine but investigations are ongoing.”
Kidd’s briefing came after the Australian Health Protection Principal Committee, along with the Australian Technical Advisory Group on Immunisation (Atagi) discussed the case at a prescheduled meeting on Friday.
However, while similar cases have led to the suspension of the AstraZeneca vaccine in other countries, he said that investigations were ongoing into the link between the disorder and the vaccine.
“Atagi, in conjunction with our independent regulator, the TGA, have been monitoring reports from overseas of these possible clotting disorders occurring four to 20 days after vaccination, including the condition known as central venous spine thrombosis, and closely engaged with colleagues in these discussions.”
The TGA updated its guidance on the AstraZeneca jab last month, saying there had been no proven link between the vaccine and the development of blood clots.
It followed a European Medicines Agency review into clotting cases that found the vaccine was not associated with an increase in the overall risk of blood clots and that the benefits outweighed risks of side-effects.
Atagi met earlier this week to discuss the issue but made no changes to its guidance on the vaccine.
The World Health Organization has also backed the vaccine, while AstraZeneca has previously said that 17 million people in the EU and UK have received the vaccine and the number of cases of blood clots reported “is lower than the hundreds of cases that would be expected among the general population”.
But a number of other countries have taken steps to partially suspend the rollout of the vaccine in the wake of similar clotting cases.
On Wednesday, German health authorities in Berlin and Munich suspended the rollout of the AstraZeneca vaccine for those under the age of 60 following new concerns around rare blood clotting. It came after the country’s medical regulator announced receiving 31 reports of blood clots in recipients of the vaccine. Nine of those people died.
A day earlier, Canada made a similar move due to the same concerns, halting the rollout for people under age 55.
Canada’s National Advisory Committee on Immunisation cited data from the European agency that suggested the risk of blood clots following the vaccine was potentially one in 100,000. The data suggested women under age 55 were most at risk.
The vice-president of the Australian Medical Association, Chris Moy, said the low case numbers meant “there’s a lot of work to try to work out if this is a real association or purely chance”.
“As such at the moment, there’s no sort of change in the advice, because the overall benefit, clearly in Europe, the benefit is greater than any potential risk,” he told the ABC.
“That’s what we need to do in Australia right now. We need to go through the processes calmly and trying to work out if this is real, or if it’s chance, just like by luck, and if it is real, what is the overall benefit versus the risk of any of the vaccine – both at an individual and population level.”
More than 541,700 people have been vaccinated across Australia, with about 115,000 of those delivered in Victoria as of Friday morning. The vast majority of Australia’s vaccine supplies are made up by the AstraZeneca shot, which is being produced in Australia by local manufacturer CSL.