Topics: Vaccine agreements and development; Manufacturing; Vaccine budget; Cold chain distribution network; Indemnity; Provisional determination and provisional approval; Private contracts; Expanding the Pfizer agreement; Expectation of an effective vaccination process being completed; Communications strategy;
I’m delighted to be here today at the Therapeutic Goods Administration to be joined by the head of the TGA, Professor John Skerritt.
He’s our nation’s regulator and chief with regards to medicines and vaccines. And we have good news.
We know that in a difficult world where the numbers have continued to increase – we’re now at over 51.2 million cases very sadly, globally, and over 1.25 million lives lost, and these numbers are increasing on average by over 500,000 cases.
And very, very sadly, we’re seeing over 7000 lives a day being lost on average, with cases accelerating.
So against that background, Australia is well placed and increasingly better placed in not just securing but approving an distributing vaccines.
In particular, I want to announce today the Therapeutic Goods Administration has given provisional determination for the first two vaccines. That is for the AstraZeneca vaccine and the Pfizer vaccine.
John will explain in more detail, but provisional determination means that a vaccine has been given a pre-approval before receiving a provisional approval.
It essentially expedites the process and brings critical medicines or vaccines to Australians at a faster rate than would otherwise be the case but with an absolute premium on safety.
We have already approved, through the regulatory process, and in particular the provisional process, Remdesivir.
That’s being provided in Australian hospitals to Australian patients. I spoke with the Deputy Chief Medical Officer, Dr Nick Coatsworth, immediately before joining you, and Nick confirmed that that approval, which was given in July, has led to a therapeutic medicine being made available to Australian patients in hospital.
As a government, we were able to secure the supplies at a time of global shortage, but as a regulator, John and his team were able to do the safety work and to make that provisional approval, which has led to Australian patients being given a medicine, which is of particular import for those who have serious complications from COVID-19.
Importantly, all of this came from the March 2018 reforms of establishing the two pathways of provisional and priority approvals.
We didn’t know which medicines, which conditions, which vaccines in the future would require provisional and priority approvals.
We did know that there would be circumstances that would occur.
This is the moment where the prior preparation has brought Australia to the point where we are using the regulatory changes and reforms that we put in place two years ago.
John, I want to thank you and your extraordinary team of regulators, scientists and we’ll join our scientists shortly – although, of course, we’ll pause at 11AM.
But to see them in action is to see some of Australia’s finest in action.
I’m also delighted to announce that the Government has secured, as part of its agreement with Pfizer, full cold chain logistics distribution for the Pfizer vaccine.
The Pfizer vaccine is what’s called an mRNA vaccine. We have 10 million units of that as part of a $134.8 million unit, four-vaccine strategy.
The world has never had an mRNA vaccine. It’s expected that it will require a cold chain of -70 degrees.
We have secured that cold chain for Australia. It’s well ahead of expectations. We are well ahead of schedule.
We are on track to deliver vaccines to Australians, commencing in March of 2021. And that is I think extremely important news.
So whilst, again, the advice from the National Incident Centre today is that we may well have another zero community transmission case day for Australia – they’re still waiting on two jurisdictions – we nevertheless have to be aware that we won’t be out of this until we have a nation which has had a full vaccination program.
But we are on track to deliver those vaccines.
We have secured already a national cold chain distribution program as part of the agreement with Pfizer.
And in addition, we now have the first two vaccines on the provisional determination pathway.
And I’ve been advised by John this morning that, not only are the other two vaccines that we’ve acquired expected to take part in that, but there are additional vaccines from around the world which are inquiring about using this breakthrough Australian regulatory process.
So, I’ll hand over to John to explain what he’s doing, working within Australia with the vaccine companies but also with international regulators. And then, secondly, we’d be happy to take any questions after that on this or other topics.
Thank you, Minister, and thank you, members of the media, for your interest.
So, what provisional determination means is that the condition for which the vaccine or medicine is treating is serious or life threatening, and clearly COVID is.
But there aren’t existing vaccines, and clearly, we don’t have existing vaccines.
And the initial data that we’ve seen and we’ve all become familiar with terms such as phase one, phase two, phase three trials.
So the data from the phase one and phase two trials, the early trials, has been very promising.
And in both cases, the two vaccines that we’ve given provisional determination to have met those criteria.
What it also means is it recognises that we’re going to learn more about the effectiveness of these vaccines as time goes on.
We still don’t know if these vaccines provide six months, 12 months, five years’ lifetime protection. No one in the world knows.
And we also don’t know what populations they’re suitable for yet.
So that information comes through in the months and years even after a vaccine is approved.
But the companies are not rushing these vaccines to us in that there’s a requirement to have several months of safety.
So even though, for example, Pfizer have the early and very promising clinical data, they’re not going to be submitting that data to us or other regulators until probably about three weeks’ time when we’ve actually got further safety, a longer period of time since people have been vaccinated.
When we get that data, we’ll look at the data jointly with other countries.
So, currently we actually co-lead the group of international regulators. It’s just a coincidence. Australia is actually the current vice chair.
And we work very closely, through endless late night Zoom teleconferences and video conferences, with those other regulators.
So we’ll reach a shared view of how safe they are and how efficacious they are.
We’ll exchange information if we have any queries or questions.
And we’ll also not provide an approval for those products until we’re confident that they meet the requirements of efficacy and safety, notwithstanding the tremendous demand of the Australian public.
When will that be? Well, obviously it depends on when we get the clinical data.
But already we’ve got early data from these companies. We’ve got data on how our products are being manufactured.
We’ve got data on their effects in animals. There’s often animal models that are very similar to humans in terms of reaction to coronavirus.
And we’re looking at that data already. So we’re not waiting until we get the full lot of data.
But I’m hoping that, all going well, that by, say, the end of January, we’ll be in the position to be able to give the first couple of vaccines an approval.
And these aren’t the only two; as I’ve said, there’s at least a dozen companies that we’ve already been meeting with and discussing in depth.
For example, we’ve got another meeting later today with those companies, because we actually expect there’ll be need for a number of vaccines to cover the market, and to cover different groups of patients.
I’ll leave it at that, and happy with the Minister to take any questions.
Minister, on the Pfizer drug, presumably it can’t be manufactured here, it’s going to be imported. Do we have the capacity to make it here?
10 million doesn’t sound like a lot for a population of 25 million.
But secondly, on that cold chain distribution network your talking about. If it needs to be maintained at a temperature of -70, presumably, it can’t be sent to the local GP to be administered – are there going to be central areas where people need to go to, to get this drug?
So, firstly, we actually have 134.8 million units of vaccines that have been acquired.
And we followed the advice of the Medical Expert Panel – led by obviously Professor Brendan Murphy and Professor Paul Kelly.
The panel’s view was that it was very important for Australia to have a mixture of mRNA, which has never been produced anywhere in the world, there has never been an mRNA vaccine, and we are at the front of the queue for the first mRNA vaccine.
There are other candidates in that space, but this was judged to be the one that was most advanced and most likely to be successful, also with the best chance of a full cold chain logistics distribution.
Now, in relation to that, the agreement with Pfizer includes that full distribution channel.
But the capacity to then provide and distribute also includes the ability to do that with general practises.
So, our distribution process, which goes to the National Cabinet this week, includes hospitals, respiratory clinics and general practises, and that’s subject to the final views of the Medical Expert Panel, which is then adopted by the National Cabinet.
So, we have not just enough for the entire Australian population, we have enough for the entire Australian population three times over.
Because we not only have 134.8 million units of directly acquired vaccines – 10 million from Pfizer, 40 million from Novavax, 51 million from the University of Queensland CSL, and 33.8 million from AstraZeneca and Oxford – but we also have, on top of that, an additional 25.5 million unit allocation as part of what’s called the International COVAX Facility.
So, we have enough, not just for the Australian population, but for the Australian population three times over.
It sounds very expensive the cold chain distribution network and the drug itself, so how much per dose will taxpayers be (inaudible)?
So, what we’ve done is we’ve provisioned all up $3.2 billion dollars for the entire purchasing arrangements, with regards to the 134.8 million units.
And so, that’s what we’ve done, and we’ve been very upfront; 1.7 billion for the first two vaccines and then an additional 1.5 billion for the second two vaccines.
But in terms of investment, there are few investments that any Australian government has ever made with a higher return on investment.
Minister, can I just ask a question about the budget and the indemnity element with vaccines?
Does that apply to the Pfizer vaccine, an indemnity element?
So, what we’ve done is we have put in place, as is common around the world, an indemnity to make sure that if there were any outcomes which were not regarded as being safe for the Australian population, then all governments around the world, on our advice, are accepting that given the circumstances.
But our protection is this man, and this building, and this place, that we have the strongest regulatory regime in the world to protect Australians.
And unless it’s safe, unless it’s independently determined by the regulator to be safe, then it won’t be provided.
But all the advice to date is that the vaccines are proving not only to be safe, but that the effectiveness is beyond our earlier expectations.
I have full confidence in Professor Skerritt, but just on the exposure to taxpayers, are we talking about hundreds of millions of dollars, or billions of dollars?
Look, our expectation is that there’s unlikely to be any exposure to taxpayers.
But in terms of the indemnity element, how much you pay?
Well, it’s a case of, if there were harm, then we would deal with it.
Very interesting thing. This administration, the Therapeutic Goods Administration, came about because Australia didn’t have what America had in the early 1960s with thalidomide.
We have just, as a government, become the first Australian government on our watch and in our time to compensate those thalidomide victims.
And that was a real article of personal faith, and John was a passionate supporter of it.
So, our expectation is that it’s never going to be required. Our responsibility is to make sure that every Australian is protected.
So, there’s no figure, because there’s no contingent liability at this space.
But if it were ever required, then as a government, we would do what previous governments never did with thalidomide, but which we have done. So, we’ve just shown our bona fides.
Professor Skerritt, just a question about the approval process; so what’s the expected timeframe on the TGA being in a position to decide whether a vaccine that’s been given provisional determination, is then given provision approval?
So, obviously it waits until we have all the data.
As I indicated, this is unusual in that normally you’d get all the data at once.
But because of the urgency of the situation, we realise we’ve already got the data on what it does in rats and mice, and ferrets and so forth, we’ve already got the data on its manufacturing, we’ve already got the data on its analyses and so forth, but we don’t have a full set of clinical data.
And Pfizer, for example, the CEO said, well, end of November, beginning of December; AstraZeneca, probably December.
Once we get that, we will go as fast as possible. And while many of you will be relaxing on the beach, sadly, many of my staff will be here in this building looking at that data.
But an optimistic message would be January.
I think the Minister’s statement that by March Australians will be vaccinated is not overly optimistic; I think it’s quite accurate.
So, we are hoping that once we get the data, if it comes in early December, by late January we’ll be in a position.
But it’ll obviously also depend on how many questions there are, and issues, whether there’s issues that we and, say, other regulators in Canada and the US and England and all that raise with the data.
So, it’s a little bit hard until you see how good and complete it is. But that’s why we’ve been having a number of meetings with the company.
While I’ve got the podium, I’d also want to mention the cold chain issue.
Equally, with their very intensive effort on development of vaccine itself, Pfizer have done some really clever work on what are – I guess Australians will call them eskies – they’re very sophisticated eskies in which require dry ice, and they actually last for 14 days and they can be filled, refilled twice.
So, without the need to connect to electricity or anything like that, these eskies, with the two refills, gives you a month and a half of cold chain protection.
And even in a country the size of Australia, you can get anywhere much quicker than that.
And of course, with flights opening up as borders are coming down, it’s actually easier to get urgent medical products around the country now.
Can I ask you about that, Professor Skerritt? Because some airlines have raised concerns about the amount of dry ice in aircraft, and the capacity to carry.
There are, there are – and as someone who formerly shipped vaccines and antibiotics via dry ice around the world in a previous job – there are limitations, you can only carry so much dry ice.
But that’s why, for example, with the announcement that as of 23 November, instead of one or two flights a day between Sydney and Melbourne we’ll be back to having dozens.
That’s actually why the opening of the domestic borders will really help the distribution here.
Can I also ask you, sorry, one more question?
Just about the provisional determination. When you made that decision, was it prior to finding out about the 90 per cent efficiency?
It certainly was. What we made the determination on, apart from the requirements about it filling a gap, was the initial clinical results that showed that it produced long lasting antibodies and other so-called cellular T cell responses.
And so it was based on the earlier trials, the so-called phase one and phase two.
The 90 per cent result is based on an early analysis of what they call the final phase – the phase three trials.
Just talking about these sophisticated eskies; how many do you anticipate we’d need? How many doses could be carried? And how would it all work? Will it slow down the process?
No. In fact what we’ve got, because it’s a smaller carrying capacity, or smaller unit, they can be distributed widely – and that in fact goes to the very first question, which was a great question, that we can therefore distribute to general practices, to 147 respiratory at clinics, to hospitals because our hospital workers will be very important, to aged care centres.
And so what that does is it gives us the capacity to speed up rather than slow down because instead of having to vaccinate in major centres where you may have queues and delays, but also some of the risks of large groups of people together, what we have looked for is multiple points of distribution.
Minister, there’s also reports today about a potential of private contracts with vaccines and people queue jumping. Is that a possibility?
So, John, I’ll let you explain the private processes.
So, the government has formed agreements with four companies.
We live in a free market economy, and the same way there’s medicines that aren’t on the PBS and you can go to your doctor and get them prescribed and occasionally they’ll say, look, this is $100, but I think it’s better for you than the PBS one at 40.
There’s nothing stopping companies, as long as they have the TGA approval, to put that vaccine on the market in Australia.
And there’s already some private vaccines in other areas of treating diseases.
So it- the products would require TGA approval.
We already have the priority designation for the AstraZeneca and the Pfizer, so we won’t be doing the private vaccines at the expense of the four vaccines that the Government’s procured.
But if, say, after we’ve done those two, if another company came along that wasn’t part of a procurement thing, we would assess.
We have no limit on the number of vaccines that we will be assessing, although obviously the more we do the busier it makes.
And we will also be working with countries in our region, together with the program that Minister Payne and Minister Hunt announced recently, and the Prime Minister.
So we will expect, over next 12 months, to probably be looking at a dozen different vaccines, including some private ones.
So you’ve secured the 10 million doses at Pfizer, for example, so that wouldn’t mean that I – not as a health worker, or a vulnerable person – that would mean I could then purchase a Pfizer vaccine?
Not one of those 10 million.
So Minister, now with these vaccines, how long do you think it would be for an effective vaccination process to being completed for Australia?
We want to see all Australians have the option of being vaccinated during the course of 2021.
Our distribution process is set up to achieve that.
What we’re seeing is that in all four vaccines, we have arrivals throughout the course of the year, different times commencing.
The first vaccines from AstraZeneca are likely to be available, but subject to clinical approvals and data and regulatory approvals – they’re likely to be available as of January.
But the expectation is the approval process which John has set out, will mean that by March for example, both they and the Pfizer vaccines are likely to then be administered, beginning with the population of priority being the health workers, and the elderly, and the aged care workers.
Very common sense, I don’t think there’s any dispute about that, and then making it available progressively to the general population.
So Australians can look forward to a return to a reasonably normal life by the end of next year?
Well, we’d like to see Australia back to a COVID-normal by Christmas, and then we’d like to see Australia at a place where we are as fully vaccinated as people choose, because it will be voluntary, by the end of 2021.
Of course, we see the numbers globally and the world will have these challenges, and so we have to make sure there’s vaccinations in Australia, but we want to encourage global vaccination programs, which is why we’re taking our lead and we’ve allocated $500 million to support vaccination in the Pacific and in our region.
So we’re taking care of Australians, but we’re also seeking to be good international citizens.
Has this Government got an advertising or communications plan in the works for when the vaccination’s approved?
Yes, absolutely. That’s still being developed because it will depend on which vaccines and when.
But again, I’m setting the expectations on the basis of best available advice for commencing in March.
But what we want to do is, in a way, what we did with the Immunisation: Get the Facts campaign, which was led by the great Ian Frazer, and that’s about providing knowledge, but also confidence in terms of safety.
One thing I would say is Australians are great vaccinators.
We’ve just had 17 million Australians have flu vaccines this year, up from eight to 11 to 13 to 17 million vaccinations over the last four years.
And we’ve just, even through COVID – and this has been one of my great surprises of this year – we’ve seen our five-year-old vaccination rates increase successively through the June quarter and September quarters, both to record levels.
We’re now at 94.9 per cent for five-year-old, general population rates and 97 per cent.
So we’re confident that Australians will take it up and take it up in very large numbers because they’re- it’s an amazing population, the Australian population, as we’ve seen through COVID, and as we’ve seen through vaccination.
But our job is to provide exactly that confidence, information and advice.
I appreciate you said that Australia’s secured 134 million doses, looking at other suppliers. But just looking at Pfizer, are you interested in getting more than the 10 million doses already secured?
We’ll continue to be guided by the medical expert panel.
The one thing I would very strongly counsel against is putting all the eggs in one basket.
The advice from John, from Professor Murphy, from Professor Kelly, from ATAGI which is the technical advisory group on immunisation, right from the outset is you must have a broad distribution because different vaccines will not only operate in ways that are different, they might apply to different age cohorts or differing degrees of chronic disease within the community.
So it’s absolutely critical to have a variety of vaccines, and what we’ve done is followed the medical advice in terms of which vaccines and how much of each, and we have options in all for contracts to have additional vaccines if more are required.
Okay. Thank you very much.