LIAM BARTLETT:
The newest vaccine has been given the green light. Already widely used in the United States, Australian arms are set to receive the Moderna vaccine, with the Government announcing the first 3 million doses will arrive next month and go straight to pharmacies. That's the good news, to make it nice and easy to get the jab - certainly no excuse. Now, our regulator, the Therapeutic Goods Administration, or the TGA, has approved Moderna for use in Australians aged 18 and over. Moderna of course, like Pfizer, is an mRNA vaccine, also delivered in two jabs, recommended to be administered some four weeks apart. The Head of the TGA here in Australia, Professor John Skerritt, joins us on the program this morning. Professor, good morning.
JOHN SKERRITT:
Good morning.
LIAM BARTLETT:
Professor, thanks for your time this morning. So your knowledge, to the TGA's knowledge are there any side effects associated with Moderna.
JOHN SKERRITT:
There are some mild side effects that people may get within the first day or two days, only a proportion of people, and they're usually sore arm; tiredness; some people may feel nauseous; some people may get shivers. But they're, they're very minor and they pass. There's a rare side effect that especially younger males get, affecting their heart, but again, in most cases those effects pass in a short period of time. And we've got very good at detecting them because of the roll out of Pfizer, which is a similar vaccine.
LIAM BARTLETT:
Right. But there are no other effects in terms of the blood clots we've heard about with the AZ vaccine, that sort of thing? There's a fair few of these have gone into the arms of Americans so far.
JOHN SKERRITT:
[Talks over] Well with- Yeah. So, so, the AZ blood clots are still extremely rare we've got to remember, and AZ remains a very good vaccine. But, the Moderna vaccine has gone into hundreds of millions of people worldwide - well- 140 million plus in the US - and so we're quite comfortable with the safety data we've got from the US and, as I said, there's very few serious effects.
LIAM BARTLETT:
Well, which brings me to the timing on this. Why has it taken the TGA so long to approve this? It was first given...
JOHN SKERRITT:
[Inaudible]…
LIAM BARTLETT: … the 20- 22 December last year, Professor, in America. And as you just pointed out, quite rightly, 140 million doses of this already delivered in the United States.
JOHN SKERRITT:
[Talks over] Yeah. That statement's totally wrong, with respect. This is the fastest approval TGA has ever done on any vaccine - we did it in 23 working days. So, the company only applied to TGA on the 8 July - that's when their submission was complete and accepted to us. In fact, we've been criticised for doing it in 23 days. The way we did it was people working nights and weekends, and working very closely with other countries on what they'd seen with the vaccine. So it certainly was not TGA taking a long time. As I said, if you only receive a submission in July, and you approve it on the 9 August, that's pretty damn quick.
LIAM BARTLETT:
I'm not criticising the quality of your work, per se. I'm asking why it takes that long when it's been in the system since the 22 December.
JOHN SKERRITT:
[Inaudible]…
LIAM BARTLETT:
We've got 140 million people overseas- What I'm essentially asking you, Professor, is why don't you, why don't you rely on the expertise of medical personnel who've already approved it in the United States? Is their science not as good as ours?
JOHN SKERRITT:
We work very closely with the US on- and indeed other countries, on all of these vaccines - in fact, we talk to them daily. But different countries, including the US- for example, the US has not approved AstraZeneca, so, different countries reach different decisions based on the data. And of course, you can only make a decision once you receive an application - we only received this application in July. So we received it. It's really important, absolutely critically important for Australia to have all the data on the vaccine.
And I'll give you an example that saves lives. So sadly, there's been a few deaths, a small number with AstraZeneca side effects. But the Australian experience is a lot better than the British experience. So, in England, and the UK more broadly, about 18 per cent of people who have the serious side effects from AstraZeneca have died. While every death is tragic, in Australia we've had 6 per cent. And so our safety track record, because we were able to build on information that we had at our own fingertips, has actually saved lives here in Australia. And that's why for all medicines and vaccines, it's important for us to have the information at our fingertips. But we work every day of the week with those other countries because we do work as a global group to identify safety and performance issues with all medicines and vaccines.
LIAM BARTLETT:
And speaking of that, Professor, if I can just flick back for a moment, because we've had lots of calls to the program about this, about people who want to travel back to see relatives in the United Kingdom. And the AstraZeneca, our AstraZeneca vaccine still not recognised by UK authorities - only the British version. When will that change?
JOHN SKERRITT:
So, we're working very closely, not just us as the regulator but also through our Foreign Affairs Department, and the Immigration Department. We're working on the recognition of Australian vaccines, and there's a rebranding of a vaccine. And we are also talking to the heads of those other agencies and working government to government. So, of course at the moment travel internationally is limited, but we're aware of the importance of recognition of each other's vaccine. So it's an active area of work between governments.
LIAM BARTLETT:
When do you expect that to change?
JOHN SKERRITT:
I think it will start to change country by country. An important thing also is Australia recognising overseas vaccines for incoming travel. So for example, in Asia and the Pacific, there are a number of vaccines that we have not looked at. And so we're also providing advice to governments on some of the other vaccines that haven't come to Australia. So it's a reciprocal thing, and that [indistinct]…
LIAM BARTLETT:
Yes. But, but help me understand this reciprocation. Because we take the vaccine from England, from the UK, from Oxford.
JOHN SKERRITT:
Yep.
LIAM BARTLETT:
So we make it here under licence, and yet our version is not recognised in turn by the UK. How is that possible?
JOHN SKERRITT:
Because the reason why it does require the UK to recognise it is to look at the manufacturing data in Melbourne. So vaccines are a little bit like Christmas cakes in that you might have the same recipe, but if you make them at different sites they come out differently. We believe the Melbourne vaccine is identical to vaccine manufactured in Europe, or the US, or whatever, but we are working together with the British regulator and other regulators in Europe to provide that data. And- but the decision will be theirs. They decide who comes into their borders. But I am expecting it will be a positive decision.
LIAM BARTLETT:
And when are you expecting that decision?
JOHN SKERRITT:
It will be in the coming months. But again, it is up to the UK Government.
LIAM BARTLETT:
Well, its bureaucrat to bureaucrat, so we can wait for months and months.
JOHN SKERRITT:
Well, it could be minister to minister. I know it is an area that is being discussed at ministerial level between the two countries.
LIAM BARTLETT:
And just finally, Professor, when we talk about safety, that word safety - what liability does the TGA carry if something does go wrong with these things?
JOHN SKERRITT:
So the Government, as you may be aware, has a indemnity scheme that's being developed so that doctors can provide, and pharmacists can provide these vaccinations with confidence. It's a shared responsibility, but Government will underwrite that, together with the ability of individuals to retain their so-called common law rights to, to seek retribution through the courts. But, but the actual scheme is being fleshed out as we speak.
LIAM BARTLETT:
So at the moment, if something goes wrong, you do what? You just go to the GP and they claim on their insurance.
JOHN SKERRITT:
So there's a range of schemes. There's GPM insurance, but it will be retrospective. And so even though the details, as I say, there are meetings underway even today and tomorrow with the peak medical organisations, and with the governments of the states and territories about the scheme. But even if the scheme is only formally announced in the coming weeks, it will be retrospective to date of approval of those vaccines.
So if someone has been one of these rare cases who has suffered, they will be able to make the claim even if their side effects occurred a few months ago. And, and what's next on your list?
JOHN SKERRITT:
Well, we'll be certainly-
LIAM BARTLETT:
[Interrupts] What's, what's on the, the number one on the hit list in terms of approval? What are you working on at the moment?
JOHN SKERRITT:
Well we're certainly, we're certainly busy, even though I said we managed to get Moderna through in 32 days. There are variants of vaccines and, and we're talking- we've talked to well over a dozen other vaccine companies. We don't announce those discussions at this stage because they're commercial until they put in, in confidence, until they put in a formal application.
But a real focus of what we're doing at the moment are on treatments. Because while vaccines are really central to the response, the medicines will also be important for, for COVID-19. And there's some exciting medicines, about six or seven of them coming through the system, and we're starting - in some cases, we're almost finished - the review of particular medicines. And I'm expecting in the next couple of weeks we'll be announcing decisions on the first couple of those medicines.
LIAM BARTLETT:
Look forward to it. Professor Skerritt, thank you very much for your time this morning.
JOHN SKERRITT:
Thank you for your time, Liam.
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