An expert medical panel has confirmed a second case of a rare clotting disorder has occurred in a patient in Australia after receiving the AstraZeneca COVID-19 vaccine.
The new case was in a woman in her 40s from Western Australia and WA Health Minister Roger Cook said she is in a stable condition in intensive care in Royal Darwin Hospital.
She received the vaccine in mid-March in regional WA. About a fortnight later she went to a regional hospital and was then transferred to Darwin.
The vaccine safety investigation group, which advises the Therapeutic Goods Administration, met on Monday evening and concluded the case of thrombosis with thrombocytopenia was likely to be linked to vaccination.
“There have been about 700,000 doses of AstraZeneca COVID-19 vaccine administered in Australia to date, so while numbers are small, two cases of the thrombosis with thrombocytopenia syndrome equates to a frequency of 1 in 350,000,” the TGA said in a statement.
TGA head Professor John Skerrit said there were no other cases of this rare condition being investigated by the medical expert groups at the moment, but he encouraged doctors and hospitals to report any suspicious side effects.
“We are encouraging as many doctors and as many clinics to report anything suspicious, and we will do the detective work,” he said.
Professor Skerrit said the UK had found the risk of the clotting side effect was one in 250,000, so in Australia so far it was lower but either way it remained rare.
“That’s an extremely remote and unlikely event,” he said. “As I’ve said before, your chances of winning lotto are much, much higher.”
The vaccine safety panel found the case of the rare side effect in the WA woman was similar to those in the UK and Europe. The thrombosis with thrombocytopenia syndrome includes blood clots, a low blood platelet count, and blood test results similar to other cases of the syndrome.
Professor Kelly said it was important to remember COVID-19 remains a major risk around the world, and the AstraZeneca vaccine remained highly effective at preventing death and severe illness.
“We have had few people who have already been exposed to the virus or are currently protected by vaccination,” he said in a statement published online.
“This means we remain at risk if there is an outbreak, and every outbreak can put our most vulnerable people — especially older Australians — at risk of severe illness and death. For this reason, the vaccine is even more important.”
Professor Kelly urged Australians to get vaccinated when their time came.
“Take the vaccine you are offered. It is safe and effective,” he said.
Health Minister Greg Hunt said on Tuesday the vaccine program with AstraZeneca for Australians aged over 50 continues, and more than 56,000 doses of Pfizer and AstraZeneca vaccines were administered on Monday.
“Vaccinations save lives, vaccinations protect lives,” he said.
“Vaccinations are a fundamental part of the capacity for each individual to protect themselves, but also to play their part in protecting everyone else in Australia.”
Opposition health spokesman Mark Butler said the new case of clotting showed the importance of having as many vaccine options as possible.
“We’ve been saying for many months now, Australia needed more vaccine options on the table,” he said on Tuesday morning.
“Here in Australia we don’t have those backup options and as a result our rollout – already way behind schedule – has been completely run off the roads.”
The first case of the rare side effect was confirmed on Good Friday, in a 44-year-old Victorian man.
Last week the Australian Technical Advisory Group on Immunisation updated its advice on COVID-19 vaccine in response to its review of increasing data about the serious condition, saying the Pfizer vaccine was now preferred for people under the age of 50.
The government signed a new agreement with Pfizer in response, with Australia set to receive a further 20 million doses of that vaccine before the end of the year.
The AstraZeneca vaccine was set to be the cornerstone of the nation’s vaccination program, with CSL producing 50 million doses in Australia.
The government has conceded the rollout must be “recalibrated”, abandoning the goal of having all Australians who wanted a vaccine immunised by the end of October.
Prime Minister Scott Morrison said on Monday the focus now was on ensuring the vulnerable and elderly as well as critical frontline workers were vaccinated before the worst of the winter months.
“We hope to be able to move into the balance of the population as we get into the second half of the year,” he said.
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Rachel Clun is a federal political reporter at The Sydney Morning Herald and The Age, covering health.
Daile Cross is the Deputy Editor of WAtoday.