PATRICIA KARVELAS:
Health authorities in Australia are resisting calls to pause the rollout of the AstraZeneca vaccine while a potential link to blood clots is investigated. Half a dozen European countries including Spain, France and Germany have temporarily stopped using the vaccine after around 40 people in the Netherlands developed blood clots. Experts say it’s unlikely the vaccine is to blame but Nationals Senator Matt Canavan says authorities should err on the side of caution.
[Excerpt]
MATT CANAVAN:
I don’t think all the capitals of Europe have been overtaken by anti-vaccine zealots. There’s obviously legitimate concerns here. And given that we’re a country where there is not really an imminent threat of coronavirus, I just don’t see how the risk of the vaccine outweighs- or is better, sorry, than suspending right now and seeing what evidence comes out from Europe.
[End of excerpt]
PATRICIA KARVELAS:
For more, we’re joined by Professor John Skerritt, the head of the Therapeutic Goods Administration. Welcome to the program.
JOHN SKERRITT:
Good evening Patricia.
PATRICIA KARVELAS:
Can you explain why these incidents of blood clots have been linked to the AstraZeneca vaccine?
JOHN SKERRITT:
Well, linked is probably too strong a word. What’s been found is that with people who’ve had vaccinations, there’s been reports of blood clots. The challenge is, of course, that blood clots are one of the most common medical problems that people have. In fact, at any one time in someone’s life, about eight per cent of Australians, eight per cent actually present to a doctor with a blood clotting disorder. And every day, at least 50 people, 50, five-zero, actually are diagnosed with VTE, the major form of deep vein thrombosis. So, this is a very common medical condition. And the same way that if you took, say, Richmond supporters, you would get a statistically high number of people with blood clots. Any group of Australians, especially older Australians, will have it. So, we’re not seeing cause and effect.
PATRICIA KARVELAS:
Okay. But significant nations are now saying they want to pause the vaccine rollout. Why are they doing it?
JOHN SKERRITT:
Well, interestingly, the European Medicines Agency, which is the overall European Union group who’ve looked at the vaccine, are not advising that the rollout be paused. These are individual countries who by law can make their own individual decisions. And similarly, the UK, which has actually got the real world experience of 11 million doses in people’s arms of this vaccine, have not found an increased prevalence of blood clots. And just in the last 24 hours, they’ve gone on their website and said people should still get the AstraZeneca COVID vaccine.
So, we don’t believe that the evidence is compelling. We believe that sadly there’ll be a wide range of medical conditions with people who’ve been vaccinated as well as people who’ve not been vaccinated. And that range will include anything from heart attacks through to atrial fibrillations through to immune conditions. Our role is to identify cause and effect. We’re working very closely with the Europeans on that, but we haven’t seen any plausible signals to show that there is- that this is a cause-and-effect situation. Now, we are still working close with the Europeans, but we haven’t seen anything that would give us a hint of a cause and effect.
PATRICIA KARVELAS:
Have European authorities then made a mistake, do you think, by pausing their rollout?
JOHN SKERRITT:
We believe that you've got to think long and hard before you pause a rollout of a vaccine, because in other countries where that's happened, there's been an almost irretrievable loss of confidence in the vaccine. So, for example, and I’ll use a small country in Samoa, a couple of years ago, there was an era where a vaccine was mixed up with a toxic substance and it killed two babies. Nothing to do with the vaccine. It was mixed up with a toxic substance. So, they paused the rollout of that vaccine for a while in Samoa. And what happened was that I think 81 people ended up dying of measles because people stopped going and getting the vaccinations. So, it often is- has major ramifications. It's not just a case of stopping on Monday and starting again a week later. If you pause the rollout of a vaccine, you've got to have really strong evidence to do so. And we don't believe we have that evidence at this stage.
PATRICIA KARVELAS:
I know you've just made the case for why pausing would be dangerous, but there's another side to this, and it was the one articulated today by Matt Canavan. I'm not endorsing the view, but I'm putting it to you - that Australia has had very few coronavirus cases, we've been incredibly successful at suppressing this to our enormous pride, of course. Why not pause our rollout just to be on the safe side?
JOHN SKERRITT:
Well, Australia has been in a fortunate position, and that's a credit to all Australians. But as we've seen in recent days with reports of community transmission, for example, in New South Wales, we are also very worried about the current situation in Queensland with the pressure from Papua New Guinea cases. We always remember the Papua New Guinea border is only a few kilometres away from Queensland, and we've seen an uptick in cases in Cairns and so forth from returning PNG people. And of course, we know that there is the intention to bring more Australians home. And we know that hotel quarantine is a point of some concern about potential exposure. So, we're not out of the woods. And as a result, it would be a major step backwards if the rollout was stopped without adequate evidence supporting stopping the rollout. We don't believe the evidence is there at this stage.
PATRICIA KARVELAS:
Are you worried that the comments from the National senator I just mentioned, Matt Canavan, could increase public distrust of vaccines?
JOHN SKERRITT:
That's really a matter for the Parliament. At the end of the day, confidence in vaccines is a very important thing. And I think that those who are in a position of public authority do need to reflect on their comments. But really, I'll leave that to Mr Canavan to work out whether his comments were appropriate or not.
PATRICIA KARVELAS:
How solid is the evidence that the AstraZeneca vaccine is less effective against mutant strains of the virus?
JOHN SKERRITT:
The evidence is variable, and indeed we are concerned about the mutants for all vaccines. So for example, Pfizer, even though it hit the market here first, is still- the clinical trials about whether or not it works well, for example, against the South African variants are still underway. So the evidence is not complete that one particular vaccine is across the board better than another against all the variants. What we are doing is introducing rapid regulatory approaches so that if there is an update – and these companies are updating the vaccines all the time to tailor them for variants or a range of variants; it’s what we call a multivalent vaccine – we'll be able to not have to wait ‘til large scale clinical trials. Because why we approve the flu vaccine, for example, which chan- the flu virus changes all the time, is actually by using blood cells and antibodies in the blood to demonstrate that it should work against the flu. So what we're confident about is that new vaccines for variants, if needed, will come out very soon in the coming months, and that the regulatory review will not require lengthy clinical trials as long as the technology is the same as that used in the original vaccine. So we've been doing a lot of work with our global partners, other regulators like FDA, the Europeans, the Canadians, the Japanese, on how to rapidly mobilise for these variants. But we simply don't have the complete information about which vaccines are effective against which variants yet.
PATRICIA KARVELAS:
But if proper standardised trials show it is less effective, then would Australians be justified, then, in waiting until another type of vaccine is available?
JOHN SKERRITT:
No, because the most important thing is that these vaccines, even against variants, have essentially been shown to protect against serious disease, illness and death. And so while a vaccine- for example, the South African trial showed for mild and moderate disease that the AstraZeneca one was not as effective against the South African variant for mild and moderate disease, that doesn't mean that these vaccines do not provide good protection against serious disease. And frankly, even if you are, for example, travelling to South Africa or Brazil or the variant becomes embedded in Australia, there's a possibility of getting a booster with a vaccine, say, at Christmas time or early next year or even maybe earlier than that against a variant. So there's no sense in saying, well, I'm going to wait a year until the next variant comes along and I get a vaccine. What we don't know is whether COVID vaccines will have to be given to individuals every year, like the flu vaccine, or whether it will be once in a lifetime or every three or five years. We simply don't know that yet, but-
PATRICIA KARVELAS:
[Interrupts] When are we going to know?
JOHN SKERRITT:
Well, the data, as scientists and regulators always say, the data is accumulating by the day. I suspect that there will be a need to provide boosters for some of these variants. But I think it'll be a year or so until there's a widespread consensus as to whether this will become an annual vaccination campaign or whether it's something you might have to have every three or five years or whatever. But having said that, I for one would much rather have an annual jab in the arm against COVID than facing the risk of catching COVID-19.
PATRICIA KARVELAS:
Look, I couldn't agree more personally. When is Australia expected to have access to the Novavax vaccine?
JOHN SKERRITT:
So we were just talking with them, and in fact, I'm meeting again with them this coming Monday, the CEO of the Australian part of the company. The Novavax one is coming along okay, although the clinical trials – the early results have been very promising – but the clinical trials will not be complete for another one or two months. Why the timeline about the completeness is a bit vague is it depends on how many cases of natural infection the people in the overseas trials get. So that's really a little bit in the lap of the gods.
PATRICIA KARVELAS:
Just wondering if you have a view on what should happen with PNG. Obviously, they're facing what looks like an emergency in relation to the spread of COVID-19. Should we be sharing some of our stockpile with them?
JOHN SKERRITT:
Look, I won’t pre-empt announcements that are likely to be made by the Prime Minister. I can say this is an issue that has addressed the focus of government, both officials and also ministers and the Prime Minister, in great depth in the last four or five days. And I'm expecting that a quite detailed plan will be announced shortly. But that's all I can say, Patricia.
PATRICIA KARVELAS:
Okay. You've given us a sort of hint there. Thank you so much for your time.
JOHN SKERRITT:
Okay. Thank you, Patricia.
PATRICIA KARVELAS:
Professor John Skerritt is the head of the Therapeutic Goods Administration.
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