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Five new cases of blood clots likely linked to AstraZeneca


Anastasia Tsirtsakis


6/05/2021 4:10:30 PM

But evidence indicates the benefits of the vaccine still outweigh the risks, according to the TGA.

AstraZeneca vaccine vial.
Australia has recorded 11 cases of thrombosis with thrombocytopenia syndrome out of about 1.4 million doses of AstraZeneca administered to date.

The Therapeutic Goods Administration (TGA) has confirmed five people are being treated for thrombosis with thrombocytopenia syndrome (TTS) after receiving the AstraZeneca COVID vaccine.
 
According to TGA head Professor John Skerritt, the regulator received 44 reports of blood clotting in people who had received the vaccine in the past week, of which five have a ‘likely’ link.
 
‘They are in a 74-year-old man, a 51-year-old woman in Victoria, a 66-year-old man in Queensland, a 64-year-old woman from Western Australia and a 70-year-old man in Tasmania,’ he said on Thursday.
 
‘But if you stop back and think about who is now getting the AstraZeneca vaccine, it is only, with a few rare exceptions … people over 50.
 
‘So it is obvious that future cases will be in the over-50s.’
 
All five people have been hospitalised, with the Queensland man currently being treated in intensive care.
 
People aged 50–70 became eligible to receive the AstraZeneca vaccine on Monday, after the National Cabinet agreed last month to bring the start date forward for over-50s as part of a recalibration of the vaccination strategy.
 
The move was sparked after reports of an increased risk of TTS in people under 50 led the Australian Technical Advisory Group on Immunisation (ATAGI) to recommend Pfizer as the preferred vaccine for that age group, while AstraZeneca is now being prioritised for older cohorts.
 
Out of close to 1.4 million doses of AstraZeneca that have been administered in Australia, 11 people have developed TTS, with one fatality that is currently under investigation by the coroner.
 
Professor Skerritt said that a number of those who developed the rare syndrome had ‘quite serious and significant underlying health conditions’.
 
He also noted that people with pre-existing clotting conditions did not appear to be at an increased risk of developing TTS.
 
‘The adverse event remains very rare. It remains at a frequency that’s similar to that reported by other countries using AstraZeneca vaccine,’ Professor Skerritt said.
 
Tasmania’s Acting Director of Public Health Dr Scott McKeown said the state’s Department of Health has convened an expert alert advisory panel to review the case of the 70-year-old man who developed the syndrome.
 
‘I want to reassure Tasmanians that vaccination remains the best way to protect against severe illness and death from COVID-19 and is a core element of the pandemic response,’ he said.
 
‘Australian immunisation experts report that the overall rate of this rare syndrome is about six per million people vaccinated.’
 
Professor Skerritt also sought to reassure Australians, saying that based on the medical evidence the benefit of the vaccine for over-50s still ‘very significantly exceeds the risks’.
 
‘Sadly, we see that Australia is not immune from community transmission and we’re certainly not immune from cases coming in through hotel quarantine,’ he said.
 
‘Remember that the risk of serious illness or death [from COVID] dramatically increases by every 10 years of age once you turn 50, and by being vaccinated we’re not only protecting ourselves, but we are also protecting our loved ones.’
 
AstraZeneca acknowledged the new clotting cases in a statement, and said it will continue to ‘support regulators in Australia and overseas’.
 
‘Tens of millions of people have now received our vaccine across the globe,’ the statement reads.
 
‘The extensive body of data from two large clinical datasets and real-world evidence demonstrate its effectiveness, reaffirming the role the vaccine can play during this public health crisis.
 
‘Our global commitment remains to play an important role in addressing the current global health emergency posed by COVID-19 by providing a safe and effective vaccine, at no profit during the pandemic.’
 
Next week Australia is set to see its biggest distribution of COVID vaccinations, with a 157% increase.
 
GPs were informed on Wednesday that their vaccine supply would be scaled up by 100 doses per week, effective immediately.
 
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Dr Robert William Micallef   7/05/2021 6:51:03 AM

The TGA’s claim of benefit outweighing risk seems to be out of keeping with the data and the incidence of covid in the Australian community. I would suggest it is not until 70 and over that there is a net benefit for this vaccine.