The Hon. Greg Hunt MP
Minister for Health and Aged Care
17 April 2021
Topics: Thrombosis/thrombocytopenia, Australia vaccine rollout.
Thank you for joining us this morning. I’m accompanied by Professor John Skerritt, the head of the Therapeutic Goods Administration.
As Australians will know, the TGA’s vaccine and investigation group, or what’s known as VSIG, met late yesterday, and concluded that a recently recorded case of Thrombosis, or blood clots in the arteries and veins with thrombocytopenia. Which is a low platelet count condition in a 48-year-old New South Wales woman, is likely to have been linked to vaccination.
And so, we know, very sadly and agonisingly for the family that this woman passed in hospital. So we extend our deepest and most profound condolences and sympathy to the family.
We know that this is the third case that has been likely linked to this condition in Australia. I believe the first two have been confirmed and this one is in the likely assessment at this stage.
Significantly, the woman was vaccinated on the morning of 8 April, prior to the decision by the Australian Technical Advisory Group on Immunisation, and the announcement by the Government that the Pfizer vaccine was preferred for patients under 50 years of age.
So, obviously going forward, some important things are the Government will ask ATAGI to ensure continuous review, continuous review, of all of the vaccines in terms of their safety and their efficacy. That work is already conducted by the Therapeutic Goods Administration, but continuous review is exactly why we have prioritised safety above all else.
There were, during January and February, some who had differing views on the question of conducting a full and thorough safety and regulatory process through the TGA, I think that clearly was something that was the right thing to do. Throughout the course of the pandemic we have followed the medical advice and we will continue to do that.
And sometimes that leads to very difficult and hard decisions. But we will continue to follow that medical advice because, ultimately, that is the greatest protection for Australians.
In a pandemic that, daily, produces challenges and heartaches and tragedies, the medical advice remains the paramount guiding light for Australia and for Australians.
And that underpins the vaccination program, the program which has now seen over 1.4 million Australians vaccinated and over 885,000 with AstraZeneca.Later figures will be available this afternoon, and will be posted once we have today’s figures.
But I will invite Professor Skerritt to address the facts of the case, the process of the TGA, and the next steps forward. These are, I think, important questions to give Australians an understanding of all of the safety steps where are two principal guiding lights throughout the pandemic and the vaccination program have been safety and following the medical advice.
Thank you, Minister, and good morning, everyone.
Before I start I, on behalf of our department and also the TGA, I want to extend our sincerest condolences to the family of the lady who died in hospital recently.
As the Minister is indicated, the Vaccine Safety Investigation Group concluded that the case was likely linked to the vaccine. And it’s the third case of a report of thrombosis with thrombocytopenia from this vaccine.
That means the prevalence in Australia is similar to that reported in the UK. So, the UK has reported about four or five cases per million. This is about one in 300,000 for the Australian situation.
Now, clearly, we can’t describe to many issues relating to the lady’s clinical conditions for reasons of personal privacy. But as the Minister indicated, she was isolated before the decision and the announcement by Government that the Pfizer vaccine was preferred over 50.
The case was particularly complicated to make a call on because the lady had a number of underlying medical conditions. And one of thing is that has distinguished almost all, but not every, almost all cases of this unusual, rare condition, and it is a very rare condition, one in 300,000 or so from our experience in Australia, is that there were these antibodies that normally cause the platelets to drop down in their number. These antibodies were missing in her case.
So, it was an atypical case. And this issue is being further examined. Again, there is a further review of patient’s underlying mental conditions. There’s a further review of other blood tests and samples that were taken, of course, from clinical investigations.
And also, the New South Wales coroner has announced, again, for all cases associated with unexpected death to do with the medicine of vaccine or accident or misadventure, there will be an inquest, so more come out during the inquest.
The autopsy we expect will be performed early next week and that may also reveal further information. If either the tests or the autopsy show alternative signals coming through, the VSIG committee will meet again to review the results.
So, I just want to emphasise that there is comprehensive information available from health professionals, and also for patients, on how to identify these very rare signals of what is a very rare syndrome.
And also for doctors advising what to do if they suspect their patient may have such a case. We do have cases, because of the widespread information on safety issues to do with vaccines in general, we do have a significant number of cases of all sorts of things such as blood clotting, such as other conditions reported to us, and we have a team working around the clock looking at those.
But at the moment, the evidence is that we don’t have other cases like this in front of us. But, of course, things can change day by day.
But these remain a very rare number of conditions, a very rare condition. And, again, the current advice of the Therapeutic Goods Administration and of ATAGI is that the balance of risk versus benefit, the balance of benefit is positive, particularly for those over 50.
Because the very sobering statistic that even though Australia has been protected from COVID, and having 910 deaths, 910 sad and tragic deaths, that 99.5% of those deaths are in the over 50s so the risk and implications of becoming seriously ill or dying from COVID is so much greater for over 50s and that is why authorities are continuing to encourage vaccinations in those populations. Thank you.
Thank you. I might start with those on the telephone and then those in the room, if that’s alright.
I think, James Campbell?
Professor, could you just go back to what you are saying about the underlying medical conditions and the antibodies?
Are you saying that, in relation to the deceased, that she had a condition that would have, had it have been checked for alerted people to the fact she was at more danger of a reaction to the vaccine? Or are you saying that the underlying medical conditions that made it more likely that she would have had this reaction.
In which case, the application would be that the chances of someone having this reaction who was otherwise healthy would be much, much lower than the one to 300,000 that you’re talking about?
No, we’re not drawing that conclusion, James.
All I’m indicating is that the investigations, and also the ability to attribute cause and effect are complicated by the fact that this individual had some underlying medical conditions which we won’t talk about because of privacy reasons.
We’re not saying that they necessarily put her any greater rest of this adverse event. The only conditions that appear to put people at this increased risk is the very rare symptom of heparin induced thrombocytopenia which is quite a rare condition. And also previous cases of thrombosis and thymocytapenia, which is rare.
So, clotting editions, or thrombosis, are actually quite common in Australia. I think there’s something like 50 diagnoses every day. People with clotting conditions are not told not to take a vaccine. They’re not contraindicated, in other words.
So we’re just saying that the range of issues that are still under investigation complicated the panel and the TGA reaching that conclusion.
I think James was also asking about the negative test.
Oh, the negative test. Sorry. You also asked about the negative PF4, as we call it, test.
The PF4 test is positive in almost all, but not 100 per cent of people throughout Europe. And of course, they’ve had a couple of hundred people because they’ve had many, many million doses administered. And in Europe, most people have that positive.
This patient, it also is complicated by the fact that she came back negative even on retesting. And so this is a most unusual case as far as its clinical profile, and that’s why it certainly hasn’t been closed. And as we get further information, we will reconvene the panel to talk about further information as needed.
Great. If I may go to Naveen.
Just a question, both of you can have a look at this. An event like this could be a big blow to vaccine hesitancy. How concerned how are you about that?
And how important is it that the message that this candidate is overwhelmingly safe be spread out into communities which don’t speak English as a first language?
So the Chief Medical Officer, Professor Paul Kelly, directly addressed this yesterday.
And Professor Kelly’s message to the nation is that vaccines are overwhelmingly safe, effective, recommended that- in a world with some days now over 800,000 cases, the risk and threat to Australia, not from within the disease, within our borders, but from possible incursion at some time, remains real.
To see those global case numbers rise above 800,000 on some days and 700,000 on many days at the moment reminds us that we are in a safe and fortunate position. But that cannot be presumed or guaranteed. And that’s why vaccination remains so important.
And we have put the medical advice and safety above all else, and we will continue to do that. That’s our pledge, to put the medical advice and safety above all else. And that’s why we’ve asked ATAGI to put in place continuous review. And I do thank Australians for continuing to come forward in large numbers for vaccination. And by tomorrow we’ll have the weekly update and they’ll be able to provide those figures. Today, of course, we’re focussing on this case. And obviously our deepest sympathies to the woman and her family.
If I might turn to Lizzie.
Yes, good morning, Minister. Quick question, does this at all change the strategy of the rollout at all? Or is it just, continue on as normal?
No. So the strategy will continue to be advised by the Australian Technical Advisory Group on Immunisation, the Therapeutic Goods Administration. Obviously, National Cabinet is looking at some of the options beginning Monday.
But it’ll be a continuous process which the Prime Minister has set in place with the premiers and chief ministers. But the medical advice remains. If medical advice changes, as it has with regards to decisions about the borders with China and then subsequently other countries.
As it did with the University of Queensland vaccine. And as it did only just over a week ago with regards to the difficult, but important decision with regards to Pfizer being the preferred vaccine for under 50s. Then we’ll follow it.
That advice is under constant review at our request. But as both the Chief Medical Officer yesterday and as Professor Skerritt has said again today, the balance for Australians is very clearly in terms of vaccinations.
Ultimately, it’s a global pandemic. The numbers are rising again to extraordinary levels. And in other parts of the world, there is agony and hardship on a societal wide basis. And so ultimately, these vaccinations will be fundamental to protecting the nation as a whole.
Our Olympians. Are they getting vaccinated?
So that’s under consideration. We’ve received a request in the last 48 hours, and that one of the items that National Cabinet is considering is the option for people who are travelling on national- critical national business to be vaccinated in 1B of the critical workers phase.
So that will be considered over the course of the coming week. There’s not been a decision, but it’s an appropriate question. We sure want to see our Olympians get to the Olympics and we certainly want to see that their safe. I won’t pre-empt anything, but go ahead. You’ve been very patient.
Just one on a study published by the Lancet Publication this week.
This might be John.
About airborne transmissions. So, it’s called, described as overwhelming evidence that coronavirus transmission is airborne. Has Australia reviewed this evidence? And will it have any impact on how we respond?
Well, we are looking at, many of us have become avid readers of The Lancet and the other top medical journals.
And The Lancet, I would say, has done in the world of service. Normally, you have to subscribe to The Lancet, but they took the decision very early on to make all these articles available to everyone that wants them.
So the issue of airborne transmission and the issue of transmission of COVID is a fundamental way of preventing a return to outbreaks of infection and so forth.
And so it certainly underpins the fact that even as we move to increase the number of people vaccinated in the community, measures like mask wearing where you can’t socially distance and measures like socially distancing as we are at this press conference today, will continue to be important.
But we are looking at that recent study from The Lancet.
And I might just add one thing at a policy level, the work of the medical expert panel or the group of Commonwealth and state chief health officers has taken cautions on the basis that this could well be the case in the hotel quarantine programme.
So the hotel quarantine programmes have been revised continuously in the same way that there’s continuous review on vaccines by ATAGI, the hotel quarantine programmes have been.
And what you’ve seen is increasingly tight outcomes from the hotel quarantines, coupled with the vaccination of the hotel quarantine workers. And that’s reducing the number of cases without ever making an absolute guarantee that it’s reducing the number of cases that come out.
Same positions are also being applied within hospitals. I’ve seen within the state hospitals in what are called red zones, zones that could be COVID positive, just the extraordinary level of protection that’s been put in place.
So this is important. And again, we have continuous review of what are called the clinical guidelines.
Thank you. I know you said there’s continuous review by the medical authorities. But, is it your expectation that ATAGI may revise its advice on the AstraZeneca, based on this recent case?
And, separately, do you expect the GP might be rolling out the Pfizer vaccine later at this stage of the rollout? Is that something that’s on the cards?
Sure. So I certainly wouldn’t ever presume what ATAGI may or may not say. Our advice to them has been very clear, and that is; we want you, our medical experts, to give us your honest, frank, fearless advice.
And if you do that, and even if it’s a difficult conclusion for us, as we did only just over a week ago in ensuring that Pfizer became the preferred vaccine for under 50s, we will take it. We will adopt and implement that medical advice. And that’s been our guiding light along with safety. So they have an ongoing role. I respectfully wouldn’t presume what the deliberations might be, but they basically follow the evidence.
When the evidence from Europe and the UK firmed up that there was a developing syndrome, they acted immediately. There had been over 20 million vaccinations with Pfizer at that time, and with AstraZeneca at that time in the United Kingdom. And yet a vastly smaller number in Australia. And one possible case at that time, they acted, they advised, we acted immediately. And that will continue to be the pathway.
With regards to future rollout, that’s under consideration through the National Cabinet process. But to give Australians a sense that obviously, as we continue with the over 70s and in the over 50s with the current rollout and then move to Pfizer for the under 50s, although there’s continuing use of the current doses for Pfizer for the under 50s, as well as those in residential aged care.
That will expand during the course of the year, and increase very significantly during the last quarter. And so there will be a push in the last quarter of the year to have as many Australians as possible vaccinated with the available Pfizer for those that aren’t in a position because of age to take up the AstraZeneca.
But it will be available for everybody who remains unvaccinated at that time. GPs remain an option. And indeed, I’ve spoken with the AMA and the College of General Practise. There’ll clearly be a mass vaccination component.
The process for that begins on Monday under the Prime Minister’s guidance through the National Cabinet. But GPs are also beginning to put forward proposals through the AMA and the College of General Practise.
So I expect that some, and indeed we hope that many, will be available and engage in that. The reason they’re able to do that is because the TGA has revised the refrigeration requirements for Pfizer.
If I may, Pat.
Minister, any words you’d like to share on the passing of Andrew Peacock?
Yes, I had the privilege of knowing Andrew Peacock. He was responsible for my first job in parliament. He helped recruit me when I was a young student studying in the United States.
And so he’s been one of the greats of Australian parliamentary life. And he wasn’t just a politician. He was a true parliamentarian.
He loved the parliament. He loved the notion of freedom. He loved the concept of each Australian being their best selves. So, to Andrew and his family. It’s a life to be celebrated as well as a loss to be mourned.
But above all else, I hope that in the midst of all the sadness, his friends and his family can celebrate one of the truly great Australian lives.
Thank you very much, everybody.
I have one more.
Sorry. Just quickly. Yesterday, the United Nations made an interim binding on Australia, potentially be in breach of its human rights, or the UN human rights charter by not allowing Australians back.
Does the government consider that finding? Are you confident that Australia is within it’s.
So I’ll leave the legal and diplomatic questions to the Attorney and the Foreign Minister. Our goal is very clear. To bring as many Australians home as early as possible.
And we’ve seen hundreds of thousands of Australians come home through the hotel quarantine system. We welcome the fact that Victoria has reopened its hotel quarantine system, and that will allow more Australians to come home earlier.
New South Wales has been the backbone of it, but Queensland and Western Australia and others have all played a very significant part. But the reopening in Victoria, I think, will help address that problem, and it will mean more Australians home, earlier.
Thank you very much, everybody.