Good morning everybody. I’m joined this morning by Professor John Skerritt, the head of the Therapeutic Goods Administration and I’m pleased to be able to report today with Professor Skerritt that the TGA has authorised two important new treatments for COVID-19 and one new vaccine.
That vaccine, the Novavax vaccine will now go to ATAGI for consideration over the course of next week, but it’s a very promising development. The first of two green lights has been given.
In terms of the two treatments, paxlovid and molnupiravir, paxlovid by Pfizer, molnupiravir by MSD. These are oral antivirals, and these two new oral antivirals mean that people will be able to have a course of treatment if prescribed by a doctor.
And that means that they won’t necessarily have to take them in hospitals such as the monoclonal antibodies, such as sotrovimab. It adds to our protection. And it will, in particular, focus on those that have mild to moderate symptoms but are at risk of severe disease.
So most particularly, elderly Australians, especially those in aged care. And between the two, there are 800,000 courses of treatment that are on order, and we are expecting the first of these courses to arrive within the coming weeks and they will be made available through prescription by GPs or in a hospital circumstance.
That’s a really important addition and I think a very important sign of hope and protection for the Australian public.
The second thing is that the TGA has approved the Novavax vaccine. John will take you through the details of that. We have 51 million units of Novavax that will be available.
Obviously we have a first dose national vaccination rate of 95.2 per cent. And we know that some people have waited for Novavax, and although we’ve encouraged everyone to proceed, we recognise that that’s a fact.
So hopefully this will encourage those people in that less than last 5 per cent to come forward. We want to have as many people come forward to be vaccinated.
The next stage is ATAGI, the Australian Technical Advisory Group on Immunisation, and subject to their approval, it will then be made available over the coming weeks, with supply coming in to the country and to be distributed through states and territories, general practices, and pharmacies that seek to order it. So that adds to the capacity.
The last thing that I want to do is to just briefly give you an update with regards to the vaccination program. Another day of over 300,000 doses yesterday, 332,000 doses, and we’ve now passed 47 million doses all up.
Very significantly, as I mentioned, the first dose rate of 95.2 per cent and a second dose rate of 92.8 per cent.
In relation to boosters, 245,000 boosters yesterday, which takes us above 5.8 million. And so we now have approximately 5.8 million boosters that have been delivered and they’re proceeding at well over 200,000 a day on the weekdays. And that’s at 58.7 per cent of the eligible population.
So, extraordinary rapid growth. I want to thank all our medical professionals, our vaccinators, everyone involved in the vaccination program, GPs and pharmacists, all of their staff, all of the states and territory and Commonwealth clinics and the Indigenous medical clinics.
And then, in relation to children, I’m really delighted. We will pass the half a million children’s mark. We’re at 492,000 doses delivered, and at about 10am this morning, we will have passed that mark of half a million for children, and that includes 56,000 yesterday.
So, only 10 days on from the commencement of the program, we’ve passed that half a million mark and we’re seeing very, very significant growth in children's protection.
So those are the critical things. The only other point that I want to make is that the GPs and pharmacies are collectively delivering over 250,000 doses a day.
So primary care is delivering 250,000 doses a day. It’s running at its highest levels throughout the course of the rollout, throughout the course of the pandemic. The states and territories I think yesterday delivered about 76,000 doses. They’ve had a capacity of up to 157,000.
So there are spaces available, in particular for boosters, for children, to come forward. If your GP currently has all of their spaces booked, please look at options within the state system. That's why they’ve opened up to allow people from three months in some states and territories, and that’s common sense given that they have additional capacity.
So, if you haven’t got the capacity to get a booking either through a local pharmacist or GP, please book through the state clinics. There are places available. Especially please keep bringing children forward and adding to those doses to the more than half a million that we will have reached by the time of this press conference.
Thank you, Minister. And good morning everyone.
I just want to flesh out a couple of things on both of the announcements. Some of the questions that we’ve had even prior to making the final regulatory decision in both cases may be of interest to the media.
What’s been made with the two oral treatments, of whether one is better than the other and why have two and so on and so forth.
Firstly, I want to say that it's common and it’s an ideal situation in medicine, whether you’re treating cancer, whether you’re treating virus or whether you’re treating common things like diabetes, to have a selection of medicines because there will be times when one is indicated for certain groups of patients and one for another group of patients.
Both medicines in the clinical trials were very effective in reducing death. There were one or zero cases in the treatment arm, in the group of people treated with either medicines, compared with, I know in one case, there was eight or nine.
So, and that of course is the most important thing, especially as these medicines will be rolled out, including in aged care, where while we are sadly seeing some younger deaths, it’s still largely the older people if you look at the proportion of people who are dying of COVID even in the last month or so.
The second thing is that it's really important to realise that the medicine trials were done in different times, in different countries, with different amounts of COVID. So, it's a little bit like the Olympics. You don't know who is the best athlete until they come up head-to-head.
And so, because these drugs were tested at different times with different amounts of COVID around, we can't really say this one is so much better than the other. So both are important, and decisions will be made whether one of these oral treatments is the right things to use, or indeed another drug which we have procured a significant amount of and it’s proven extremely valuable called sotrovimab.
That’s also used, but as the Minister said, it requires intravenous application and therefore, it doesn't have the advantage of being able, say, being applied orally, for example, within residential aged care.
The final thing that doctors will have to be aware of with both medicines are that they’re not recommended in pregnancy or breastfeeding. Fortunately, not a common consideration in aged care.
But more to the point, one of the medicines, for example, Paxlovid does interact with a number of other drugs. And so, as it is the case for all prescribing of new medicines, it will be important for the doctor to look at what the individual is on, you know, what other medicines they’re on and that will also influence the decision about whether or not they’re an appropriate candidate for which one of these particular drugs.
So, interacting with drugs sounds academic, but it can have quite significant impacts. It can either mean that other drug is too high in your body and can become potentially toxic, or it could be too low, and say, a drug for epilepsy or a particular drug for your heart rhythm would not work effectively because of interference. Or it could mean that the amount of Paxlovid is not sufficient to manage COVID.
So, these drugs will require knowledge of the other medicines that an individual is on, and we’re just so fortunate to be able to have two very good medicines coming available at the same time.
I now want to briefly turn to Novavax, because as the Minister said, while we have extremely positive and very high vaccination rates, there are some individuals and we know that the Commonwealth has not mandated vaccination, notwithstanding the massive take-up of vaccination in this country.
We know there are some individuals who have been waiting for Novavax, and it’s great that it’s finally been approved.
We’ve had a lot of questions about the approval time for Novavax, and the way we’ve done all the COVID vaccines, in order to make their approval as fast as possible, is to do what we call a rolling review. We go back and forwards to the company with questions, rather than waiting for everything to be submitted to us picture perfect complete.
And so we, and the other regulators, and indeed of the OECD countries, after the European Union, we’re the second major regulator to approve the Novavax vaccine. There are some approvals in Asia, in Korea, in India, and the Philippines and Indonesia. But of the OECD aggregates, we are the second.
It’s approved as a ready-to-use vaccine, and it’s also approved in two doses, 21 days apart. And so that will also enable a fairly rapid completion of vaccination and, I guess, our dream is that we might turn our 95 per cent up to 98- 97 or 98 per cent in this country. Who knows?
The approval is for a primary course, in other words, the standard first two doses of vaccination. Now, I know there is interest in the potential for Novavax being used as a booster or even in adolescents or as a paediatric dose.
The company hasn’t yet submitted an application to us for that, but we’re talking to them and we’ve given an undertaking, as we do for all COVID vaccines, that as soon as we get that data, we will review it as an absolute top priority.
The clinical trial data for Novavax was quite impressive. Two separate large clinical trials, which have been published internationally, showing over 90 per cent efficacy against symptomatic infection.
No strong signals of adverse events, but again, as we do for every COVID vaccine, we have a large team of people focusing on potential adverse events, and whether, for example, the prescribing advice needs to be changed. And we’ll be working closely with those European countries that have also plans to roll out Novavax.
And finally, I want to remind people that our laboratories play an absolutely critical role with all vaccines. We test every batch of every vaccine, including the COVID vaccines that come into Australia, and no vaccine goes out to Australians unless if it passes our very strict, rigorous, and extensive laboratory testing, so Australians can have confidence in that.
Thanks. I’ll go back to the Minister.
Thanks very much, John. We’ll start with those in the room, I think. Jen?
Professor, molnupiravir has been proven to be less effective than in previous studies, I think it’s down to 30 per cent in reducing severe symptoms. Do the risks really outweigh the benefit for the Australian? Can you list the side effects please?
But also, Minister, how much will the pills cost per course, will they be added to the PBS?
So to answer the question about molnupiravir. Firstly, the main group for which molnupiravir is not recommended, as out of an abundance of caution, those pregnant and those wanting to become pregnant, and indeed, we encourage their partners to use contraception both during and after the use.
So, because there hasn’t been testing, common with many drugs, hasn’t been tested during pregnancy, and some antivirals are recommended not to be used in pregnancy.
You mention the difference in efficacy. I go back to the fact that we haven’t the Olympic athletic competition here. We haven’t had a back-to-back comparison of the two drugs. And also, we do know that molnupiravir, I think with only one patient, and we don’t whether they had other conditions, it was very effective in reducing death.
So while some of the published studies show a lower efficacy, I think that there will be a number of patients who will be very suitable for molnupiravir and for whom they cannot take Paxlovid because of the other drugs they’re taking. So it’s really important to have both in our armoury.
Yeah. And so to Jen’s question. The drugs will be free. They’ll be available, although subject to prescription by a general practice or in the hospital environment.
And if it’s your GP that’s prescribing, it will be available from pharmacists. So, simple and easy, subject to the gateway of a GP, focussing on both the need, the efficacy, and the safety elements.
Nour Haydar please.
Thanks, Minister. Yesterday, the Prime Minister strongly denied that the Government was redirecting, or requisitioning, rapid antigen tests, but we’re still receiving reports from businesses who are being told that by suppliers and wholesalers.
Can you explain why that might be happening, and does the Government have the power to requisition rapid antigen tests for the national stockpile, and has the Government drawn on that power yet?
No, we have not done that. We are not doing that, and I have asked my Department overnight to refer any of these cases to the ACCC.
It is simply false, misleading, and untrue. So there are some suppliers who, frankly, have overpromised. They have overpromised to Federal, state, and to community or private purchasers.
But where those claims are being made, we are referring them to the ACCC at my request. They are simply plain false. It’s not something we’re doing. It’s not something we’re going to do.
But I would make this point that we’ve now received over 6.1 million tests and provided them to aged care. We’ve also provided the first of our rapid antigen tests to the state system, and we are seeing, in particular, improvements through the state system.
Just a local example, a friend of my daughter’s this morning had a test. She just let our family know and, interestingly, it took her 30 minutes at the Frankston Hospital Centre, they’ve done an amazing job testing.
They provided her with a rapid antigen test based on her description of her circumstances. And so that is making its way through the state system.
We provided 6.1 million to Commonwealth and we are seeing more supplies coming in. The International Freight Assistance Mechanism where we use defence, transport, and logistic support, to work with the private sector and the states is expected to see 50 million units arrive in Australia over the coming weeks for Commonwealth, state, and community purposes.
If I can go to Andrew, please.
So just on Novavax. You were saying, Professor Skerritt, that there might be a large number of people waiting for Novavax. Who does the TGA, or for the Government, envisage that these people are in, sort of, waiting for Novavax given that we’re at 95 per cent first does.
There’s 51 million doses of Novavax coming in, so is it anticipated that this’ll work pretty much alongside Moderna and Pfizer?
And just on the oral treatments. The TGA was saying in a statement that these treatments aren’t a substitute for vaccines, but down the line, you know, in a couple of years for instance, does the TGA kind of envisage that oral treatments might be used more so than, say, vaccines rather than people going back for, you know, fourth, fifth, however many booster doses might be needed for COVID?
To start with your question on Novavax. You’ve obviously got to ask individuals, or groups of individuals, what their motivations are.
There are some individuals, and there’s even social media groups, who have, for whatever reason, been worried about new technology even though the foundational technology for messenger RNA vaccines such as Pfizer and Moderna, and for Adenovirus vaccines such as AstraZeneca, have been around for some years.
The technology on which Novavax is made is an older technology, it uses a protein. And so I would have had literally several hundred emails from individuals and groups who have said, for whatever reason, we’d like to have a protein vaccine.
And so I don’t know whether it’s 50,000, 100,000, a million, or whatever, individuals. I don’t think anyone knows, but there are some individuals and this just gives them further choice.
It also, and this will be subject to decisions and discussions with countries in the region, it also provides another avenue of potential vaccine donation. I mean, Australia has really had a leadership role in Asia-Pacific through, not only its donations but also its technical support through the TGA and with vaccinations through Foreign Affairs vaccine donations. We really have helped, and the vaccination rates in places like Fiji have really been impressive.
To answer your question about not a substitute for vaccination. We do not want people to feel that if they can pop a pill they do not need to be vaccinated, because for all infectious diseases for decades, prevention has been better than cure, to put it that way.
However, we realise that even some individuals, maybe because of their weaker immune response or age or whatever, may still become ill with COVID if they’re vaccinated.
The same way with some other diseases, and so in this case, having a treatment is also beneficial even if you are vaccinated.
None of us has a crystal ball for the future and we simply don’t know whether, on one hand, three vaccinations for COVID will be enough, or whether it will be part of the annual cycle as we have, for example, with our flu shots every autumn.
Again, the same way there are oral treatments for flu that help with certain individuals who catch the flu, we do believe these treatments will be important in the long term as a complement to vaccination rather than as a substitute.
Thanks, Minister. The Health Department data that was revealed in the last, kind of, five days about disability and vaccination suggested that in regional areas the rates of double-dose vaccination were around 50 per cent in numerous places.
So, what’s being done to change that? They were supposed to be the top priority, and we’re hearing it’s a combination now of people feeling abandoned and isolated, and spending a lot of money trying to get rapid antigen tests in the thousands of dollars.
Well, so our disability vaccination rates around the country are at almost 88 per cent, and we do know that there’s been different take-up around the country.
Access has not been an issue because there’s universal access to vaccines. That’s clearly the case right around the country. And so, one of the things that we have (INAUDIBLE) why we publish that data, was to highlight that in some areas, you can have information which is provided which is not supportive of vaccination.
We saw that in the Indigenous communities, and we did immense work to overcome those barriers and to lift our Indigenous rates now to above the 80 per cent mark, to approximately 81 per cent. And that's been through that process of revisiting, revisiting, revisiting, and providing support and comfort using leaders, using trusted sources.
That’s the same with the disability community, where we’re at an approximately 88 per cent vaccination rate, but there are those and you can have clusters where there is a view that develops within a small community that may cast doubt on vaccination.
So, we’re working with states, with territories, with disability groups, and with local areas to focus on that. That is precisely why that data was published, so as in particular, to encourage those local actions.
Access, universal. But hesitancy, you can have pockets of it, as you do in the broader community – we know that there are some areas that have lower vaccination rates, Byron Bay is an example. But equally within the disability community, a view can develop.
So that's why we’ve published that, that's why we’re focusing really on those specific areas, on trying to build that confidence and lift that access.
Thanks, Minister. I've got a couple of questions on RATs, and I might start with one for Professor Skerritt. So, Professor, you previously said the TGA can't formally make an approval decision on RATs until you get a signal from the Government. Just wondering when you got that signal?
And Minister, regarding the free RATs being distributed through pharmacies from the 24th, how much will the Government give pharmacies per test?
And also, do you mind just giving us a bit of, whatever you can, on the Novavax rollout for people who want to get it? When they can get it, where they can go, that kind of thing?
Well, I’ll start with the discussion about RATs, and so I should remind you that the first rapid antigen tests were actually approved back in 2020, and in early and mid-2021 there were a number of businesses, and also within aged care, into the spring of 2021, using point-of-care supervised RAT testing.
I guess, Fi, the question you’re asking is about the timeframe of approval of the home tests for RATs, and that was an ongoing discussion, so there was no sort of trigger moment other than looking at the point of the pandemic.
So I really need to emphasise something, and if you wish, I can actually share some of these studies because they’ve been published. Where Australia was in, say, and you can pick any point of time, but let's say where Australia was in Easter of 2021, or even where Australia was in September 2021 or October 2021, even though we still had a lot of Delta around, it was, by global standards, very low.
So Australia was a low-prevalence country. Sadly, we're not at the moment, but we were back then, by an order of magnitude. And if you use widespread use of RAT- home tests, when you’ve got low disease prevalence, only about 50 per cent of the results are actually correct.
And so, back in 2021, we were at a time where it was important to contact trace every individual, and we were able to do so with the numbers. And that was really important as the vaccination rollout was still continuing for the first two doses.
So in a low-vaccinated, or still being vaccinated community, with low disease prevalence, self-use of RATs actually can lead to a lot of false results. A very different situation now, the RAT test you have with the pressure and frequency of Omicron we have now, means that you can be confident that if you RAT is positive, you’ve almost certainly got COVID.
So, I guess the main message is, it was an ongoing discussion, and it was driven by the levels of vaccination, the levels of disease and community, and the importance of individual contact tracing.
Even now, we see that individual contact tracing, individual venue notifications is still happening in WA, because they’re at a disease situation where a lot of the eastern states were several months ago.
But, of course, here in Canberra, and in Melbourne and in Sydney and in Brisbane, and more broadly in the east, we’re now no longer talking about individuals and individual venues, just because of the numbers of cases that we have with Omicron.
Great. And now, just in relation to the Pensioners Program. The Pensioners Program will begin as of 24 January.
I should be very clear that it will depend on the individual supply that’s available in any particular outlet or pharmacy.
The agreed rate is $10 per rapid antigen test. It’s free for the 6.6 million participants but that’s the fee that was agreed, and there’s the standard handling fee as well, which pertains to the packages.
Then, in relation to Novavax, the COVID Shield team is working now with general practices, with pharmacies, and with state clinics and Commonwealth clinics. They’ll take orders, and hopefully it will be available in as many of those as possible.
It will be a matter for the individual suppliers, or practices, pharmacies, state clinics, to make it available. But we do have significant quantities that will be coming, will be made available, and we want to lift as many of those people who haven't yet been vaccinated into the vaccinated groups.
And whilst our advice has been that, and remains, that the vaccines we have had are appropriate to vaccinate the entire population, we do recognise that, just as the TGA has had many approaches, as a Government, we’ve had many approaches from people who wanted Novavax, and our general practices and pharmacies have also indicated that as well.
I was having a discussion RACGP recently, and they indicated that many of their members had had many approaches from the remaining people who had yet to be vaccinated seeking Novavax. So this should provide the extra option. Hopefully it will give more people more protection, and if you protect one, you help protect all.
And there’s one other person who’s come into the room please?
Minister, thank you. On schools, it’s going to be debated at National Cabinet again today, the plan to get kids back into the classroom. Given we don't have enough RATs in the country at the moment, do you think it’s wise, this potential plan, for children who are asymptomatic to be using two tests or so a week, going forward?
So, that’s a discussion which has been led by the states through National Cabinet, in conjunction with the Department of Prime Minister and Cabinet.
It’s medical advice, and medical advice will work with the states on providing confidence to parents and to students, and it would be up to the states to provide that supply if that were a decision they went down and a path they went down and a decision they took.
But the Commonwealth is going to work with them, and we are supportive that if they do that, and have that supply, then we’ll be assisting them. But that final plan’s being considered precisely on the grounds that you discussed, in terms of the availability and the medical recommendations.
And one of the things I think that is really important here, and I think Professor Skerritt set it out very clearly, following that medical advice has meant that we’ve had one of the most accurate testing regimes in the world.
I mentioned before, the London School of Hygiene and Tropical Medicine had identified Australia's testing regime as one of the (INAUDIBLE) world. That, in turn, has allowed for contact tracing.
That, in turn has been one of the fundamentals of why we have a system with approximately one twentieth of the rate of loss of life of the UK on a per-capita basis, and one twenty-fifth of the rate of loss of life of the United States, as an example. Or, to put it another way, roughly 45,000 lives saved in Australia compared with those jurisdictions.
And so, that process has actually saved lives. And I’m hearing some commentary now which, unfortunately, is not cognisant, not aware of that massive amount of human life saved. Saved one life is incredibly important.
To have set up to 45,000 in comparison to those jurisdictions and 30,000 by comparison with the OECD is about literally saving families, communities and the equivalent of townships worth of lives.
And so, that system has been fundamental. Now, as we’ve moved to a less severe but broader scale system, we now move to a much broader testing regime.
And I think over on the right hand side in the front, please?
Thanks, Minister. Just for complete clarity, can you and Professor Skerritt say that there’s been no requisitioning, no seizures, no redirection, nothing on rapid tests purchased for private sector customers?
And are the companies who are telling their customers that the Federal Government has taken stuff for the medical stockpile, are they lying? Are they having it on?
No. They’re lying. And that’s why I am reporting them to the ACCC.
And we’ve heard that in relation to claims between states where companies have made those statements and we’ve followed that through and so it’s absolutely (INAUDIBLE).
And I’ve got to point this out, there are people in the market you will make statements and make promises and then not be able to deliver. And what we’re seeing is that, whether it is Commonwealth, state or territories, or community or private sector, that some suppliers have overcommitted and not been able to deliver.
And that can be any one of those groups to whom they’re not delivering. And there are different reasons and excuses put out.
The truth is there’s a global spike in demand. And that’s having an impact, not just in Australia, but the world. But as a consequence of these false claims, I have asked my Department to report them where we are aware of them to the ACCC.
I was going to add, sorry with the delay, Minister. I mean obviously, there’s a lot of demand for RATs and companies, quite frankly, want to do the right thing and serve that demand, and someone of them also obviously make a lot of money when they can.
We have had a lot of trouble with companies making false claims that, for example, they’ve even submitted applications to us when they haven’t even put in an application for approval.
And one thing I’m very proud of is we’ve actually, at least last time I looked at the data, TGA has approved more rapid antigen tests than FDA despite the fact that they’re 15 times bigger than us.
So, we’ve been working all through the Christmas and New Year period, looking at and approving RATs when we have the data.
But we’re getting a lot of false claims, oh well, we’re waiting for TGA to approve this product and they haven't even submitted either no data or they’ve submitted some of the data.
We’ve also, and again, the police are looking into this so I won't comment further in any detail, we’ve had comments, we’ve had issues of falsified letters of approval that companies can say: look here, I’ve got the letter saying that this product is approved by the TGA.
And it’s an out and out forgery. So unfortunately, while we’ve got a lot of companies doing some really good work, getting product out there into the supply chains, there are some who clearly are doing the wrong thing.
Can I go back, sorry, to the pills? You said it’s not recommended for pregnant women.
No. Neither is recommended.
And it will be used mainly in aged care. So can you tell me what the target age group is for both of these pills?
So, the priorities are being worked out in conjunction with the National Clinical Evidence Taskforce and working with the various sectors.
So, over the coming days that’s being done, there is a view that aged care will be one of the top priority groups. Obviously, because that’s where we’re seeing fatalities and we do know that some of our frailest members of our community are in residential aged care.
I don’t know if the Minister wants to wants to add to that.
I’ll just say this Jen; vulnerability is the principal concern which is driving the use of these medicines.
They are designed for those people who are at risk of moving with COVID from mild to moderate symptoms to severe. And so, therefore, in the vast majority of cases it won’t apply to people but that’s why having a medical practitioner assess.
And it could be somebody who is younger, who’s immune-compromised but we do know that those most likely to face the journey from a mild to moderate illness to a severe one are those that are older.
And the older you are and the more frail you are, the more likely it is that you’ll develop a severe illness, which has been the case with all of the different strains and variants of COVID throughout.
So, this is about new hope and new protection. The final clinical evidence guidelines will be released very shortly, but the TGA has approved and we’re expecting the first of these to arrive in the country shortly.
With that, I’ll finish and I just want to say to all Australians again, thank you very much for coming forward. If you haven’t been boosted yet, please come forward. If you haven't had your first or second dose, please come forward.
And finally, if you have not had your child vaccinated, there are many, many places available within state clinics, GPs and pharmacies, many of them are vaccinating to their maximum capacity. But there are lots of places that are coming available in those but if you can't get one of those, please go and look at the state or territory website and bring your child forward.
Thank you very much everybody. Take care.