And good morning everyone.
I’m delighted to be joined by Professor John Skerritt, the head of the TGA or the Therapeutic Goods Administration, the national medicines and vaccines regulator.
A number of things today. First, the TGA has approved the use of Pfizer as a COVID-19 booster for Australians 18 plus.
This is an important step, and it will mean that Australia will be one of the most highly vaccinated societies in the world, one of the most recently vaccinated communities in the world, and one of the first to receive a whole of population booster programme.
In particular, and John will go in more detail to both the decision and the processes, the TGA has approved Pfizer as an 18 plus booster and very importantly, and Professor Murphy, Professor Kelly, Professor Skerritt, ATAGI, and others have been at pains to point out that this is about additional protection, and that you remain fully vaccinated with two vaccines.
The next step is that ATAGI, the Australian Technical Advisory Group on Immunisation, will provide final advice - they have been working on an interim basis with the TGA. But subject to that ATAGI final advice, we intend to commence the General Population Booster Programme no later than 8 November.
And we have the supplies, we have the distribution mechanisms, we'll just work with the states, the GPs, the pharmacies, the Commonwealth vaccination clinics and the Indigenous vaccination clinics to ensure everything's in place, and we will commence aged care and disability as a priority.
This morning, I had a very constructive conversation with my Victorian counterpart, the State Health Minister Martin Foley, and Victoria, which of course has the most significant current outbreak will be looking to commence their aged care and disability support booster for those that are six months plus, since they've had their second dose in the imminent future.
So that's very constructive and I thank them for that.
And then finally, as I say it’s a universal booster, and so it's available for people who've had Pfizer, AstraZeneca or Moderna, although nobody who has had a second dose of Moderna would yet qualify, as that's been more recent.
But as people come to the six month plus time frame since their second dose, Pfizer will be available. John will set out other regulatory applications which are pending from different companies.
Then in terms of international travel, the Prime Minister has indicated that I've signed off on the Biosecurity Declaration Order, which means one very simple thing: from the first of November, double vaxxed Australians will be able to leave the country and return to the country.
And so fully vaccinated Australians will not require an exemption to depart Australia from 1 November. This is the first stage of our international reopening. Subsequently, we'll have a second stage focussing on students and critical workers.
We're also looking, as the Prime Minister has indicated, that early arrangements with Singapore and then we'll look at general travel for tourism and other purposes for people entering the, entering the country.
Also pleased to be able to report that, overnight, we've received our first shipment of Ronapreve, the combination monoclonal antibody therapy that will now be made available via the hospital process for treating patients with COVID-19.
And then finally, just in terms of the rollout, another 227,000 vaccinations yesterday. We're now at over 34.8 million doses. Very significantly, we've passed the 18 million first dose mark and we're at 87.4 million [sic], 87.4 per cent of Australian 16 plus who've had a first dose.
And in terms of second doses, we're at 15.4 million, 16 plus and 74.8 per cent. But just over one million Australians to come forward, to have their second dose, to achieve the 80 per cent double vaccinated rate.
So just over one million Australians to come forward to achieve the 80 per cent double vaccinated rate for the national average.
And then finally, the purpose of all of this is to protect the most vulnerable, our 70 plus population now has a 98.7 per cent first vaccination rate and over 88 per cent second vaccination rate.
I do particularly want to thank John and all of the officials at the TGA, and all of the officials and advisors at ATAGI for their work.
TGA, it's a marathon, not a sprint. John, just as a personal example, confessed to me this morning he hadn't been home to Victoria for six months - he's just been working through. And that's the sort of support we've had from our scientists and officials at the TGA, in the Health Department, and in the other departments, and also the personal staff – you know, our personal staff work phenomenal hours.
They're working until midnight last night; they're working from the earliest hours in the morning. And so, you know, it's been a great challenge as a nation, but we are immensely well served by those who are in public service.
Thanks, Minister. None of us joined the Health Department or the TGA expecting to have a pandemic.
It's been the most challenging period, but as far as importance to the health and welfare and the future of the Australian community, probably the most important work the team has ever done.
And as the Minister said, this is the result of a team effort. And no longer, no sooner does one marathon finish then another one starts.
So, as the Minister indicated, the TGA last night - and again, I use the word last night pointedly because it is that nature of business, but after business hours - so last night, the TGA made the final approval of the booster dose of a vaccine.
It's for ages over 18 years, and it's over 18 years because that's the data from the clinical trials. And I'll come back and talk about the data on which the decision was made, because that's important part of the confidence that Australians need to have and should have in the thoroughness of a regulatory process.
And that means that anyone over 18 can receive a booster dose, and again the anyone will be subject to ATAGI advice. But we are not second guessing the ATAGI advice, but the TGA advice just says over 18, at least six months.
And again, it doesn't mean that everyone needs to front up on six months and one day. It's again at least six months after the completion of a COVID vaccine primary series.
It's the same dose administered in the same way as the first two shots of Pfizer. And importantly, it was approved to go as a third dose after completion of a primary course of any of the other ones.
And as the Minister said, no one will be six months after two Moderna’s yet, but there will be people who will be at six months after AstraZeneca’s in the coming months, and there are some people who are at six months after two Pfizer’s already.
The other thing that TGA did, you're aware of at early this month, the ATAGI recommended for people who were severely immunocompromised that they could get, it's not called a booster shot, but a third shot, because their immune systems don't respond as well to the first two vaccines, but they could get a third shot 28 days after.
In reviewing the clinical evidence that is now officially part of the product information or the official approval of a vaccine, and there's a range of immunocompromised conditions and that includes down to 12 years old.
So in that case, the children down to 12, if they're severely immunocompromised kiddies, a kid with cancer, or a kid who is having chemotherapy, a kid who may have had an organ transplant, or an adult, for that matter, various stem cell transplants or on certain medicines that suppress the immune system.
So there’s a defined list of conditions on the Health Department's website. So down to 12, that's for the severely immunocompromised kids, and over 18 for the wider population.
Now, as the Minister said, it is important to reinforce that two doses of each of the approved vaccine do provide excellent protection against serious illness, hospitalisation and death. And that’s not us saying it, there’s now more than a dozen global studies that reinforce that.
But we do know that boosters may give additional protection against mild COVID and they may have an impact on having transmission. And we do know that in the elderly, and people of various shades of immunocompromised that an additional dose is particularly valuable, and it may provide reassurance for frontline health workers.
Now, just in terms of numbers, we’re expecting that by January 1, there’ll be about 1.6 million people who will be six months or more after their courses. And again, because of the efforts of the Government, including additional procurement from overseas, there is more than enough vaccine in the system to cover that, should the advice come from ATAGI to do that.
I want to, before I finish, I just want to touch on data. So, we have a regulatory submission which was in people 18 and 85 years old showing that the vaccine were well tolerated. Some people had a little bit of swelling of the lymph nodes as you often get with the various viral infections, but they when away after a few days.
There was a big study done in Israel of over million people that showed, especially those over 60, their chance of becoming seriously ill and getting infected was very significantly reduced with the third dose booster, and that’s in the over 60s.
And there was some recent results, not yet in a, in a medical journal, but on a thousand subjects showing that a third dose booster actually increased vaccine efficacy to 96 per cent.
Now, I want to finish by foreshadowing a few things, as I said, my- the staff has got into the showers after the marathon, and I'm asking them to go back out onto the running track first thing in the morning.
And we, coincidently yesterday, received not the full application but most of it, but we still have more to get, from the Pfizer application for five to 11-year-olds, and we will look at the carefully. Some of you may be aware that overnight, in fact, I think 7:00AM this morning the announcement was made, I did have a staff member who was on the committee meeting all night. I hope he’s in bed now.
But the FDA announced that their advisory committee had endorsed, with no, no no votes, the application from Pfizer, five to 11 -year-olds. That works through their system, it involves FDA making a decision, and then the US Centre for Disease Control and Protection making a decision.
We also are working with other companies such as Moderna on potential boosters. Moderna have also indicated that they have assembled data on younger age groups as well.
And of course, Novavax have announced publicly that in the next fortnight, they expect to complete the submission of data to major regulators, and that may well include Australia.
And finally, those of you will also have seen, but we believe the November 1 launch date for the rapid antigen tests will be maintained. Major supermarket chains and convenience have announced that they will have stock available from that date.
We've approved nine rapid tests to date and we have another few in advanced stages of review, working with the companies just to finalise things such as the instructions for using them.
Thanks very much.
I’ll start with Rachel and then work across.
Thanks, Minister. Firstly, you said the general population rollout for boosters will likely start on November 8, but aged and disability sectors will be prioritised.
Given ATAGI’s meeting today, could that rollout to aged care residents start as early as tomorrow? And secondly, how will the, booster shot be recorded on our vaccine certificate?
So, look, I won’t pre-empt ATAGI advice but they have worked very closely with the TGA. And so I'm quietly hope that, subject to their advice, on November 8 for the general population.
For aged care and disability, we already have sufficient support from ATAGI on the basis of their preliminary advice for that to commence. So that program, Victoria is looking to commence immediately.
Those that wish to provide self-vaccination, so there are a number of facilities and providers that do that. One example I’ve given previously is TLC. They are probably one of the leading providers with regards to self-vaccination.
They’re all preparing to do it. They do have to get consent from the residents or their resident's carers - so that process will determine it. But subject to the consent process in aged care, and those disability residents who had early vaccinations, they’re free to proceed and we’re facilitating the arrangement of those.
Second question? Apologies.
It was on how, how will our booster dose be recorded? Will it be part of our vaccination certificate? And will that be required for travellers?
No, it's not a required element. You are fully vaccinated at this, at this point in time, and then it will be, will be added to the immunisation register as is the, the ordinary course of events at the moment - you know, your flu vaccine, your children's National Immunisation Program, vaccinations and your, your doses as they arrive.
And so, that'll be recorded, be recorded on your immunisation register.
Do we have an idea of where, in what settings the rapid antigen test will be allowed? Have states indicated will they be able to replace people going to quarantine? Or be used to enter their borders?
And also, Minister, just on the booster. The original vaccine also wasn't initially compulsory, but over time certain professions were added to that list. Could that be the case for the booster?
So, I’ll speak very briefly on boosters and then turn to John on rapid antigen tests.
So, at this stage, there’s no plan or intention. And again, the Commonwealth has not been mandating other than in the aged care staff setting.
We’re, at the moment, we’re at 99.8 per cent, and I want to thank all of those staff for participating in that. And again, we’ll always follow the medical advice. So, I'll leave that to individual states or territories.
But the clear advice and the preliminary ATAGI advice, the advice from SCITAG, Professor Brendan Murphy's team as well as the TGA, is you are fully vaccinated. But the booster is, as John has set out, just that, it adds to, adds to protection.
On rapid antigen tests, firstly, there’s no constraints as to where they could be sold including online, convenience stores, petrol stations, anywhere. There are a few, few rules around the advertising of those tests.
So, they can be advertised but, for example, they can't say our test is better than their test.
So, there are controls and that’s usual for medicines and medical devices that comparative advertising and claiming- also for example, they can't claim to be diagnostic, you know, because it's a screening test and people who test positive should go and have a PCR gold standard test.
As far as the state and territories are concerned, they’re working out their own policies for rollout of those tests. For example, New South Wales Education has said they’re going to mainly target them for outbreak control, rather than testing every school child.
But now, the tests are here and some states and territories who indicated they’ll procure as well as the market, they will make decisions on how they rollout those tests.
Minister, on logistics of this, will there be reminder messages sent out to people that your six months has now passed or is it incumbent on you to do it?
And Professor Skerritt, can I ask you, is this three shots and you’re done? Or are you going to be getting, every six months, you’ll have to get another booster shot?
Do you want to start with that one, John?
Unfortunately, it was an issued with a crystal ball when I got this job.
Now, what– with other vaccines, and again, we don't have that experience with Messenger RNA vaccines, so, I don’t want to necessarily make a comparison. There are some vaccines whereby three shots gives you almost lifelong protection.
So, as I said when the vaccine was initially approved, when I, when I stood up with the Minister and the Prime Minister - it seems like a lifetime ago, but it was only in, in January, February - we didn't know about the duration of protection. And so, no one knows about the duration of protection post this booster.
The really good news is that a few months ago we were worried that we'd have to have quite different vaccines because the emergence of variants. But even with the severity of Delta and how predominant Delta has been globally, we haven't needed to change the booster.
So, unfortunately the answer is we’ll have to wait and see.
And on logistics?
So right now, what happens is that obviously it continues to roll out in exactly the same way. We have, the booster program is ready to go. We just now will work with the states and territories and with GPs. And so, it's just continuing on.
Thanks, Minister. Professor Skerritt, what do you think the timeline will be using the FDA as an indication for kids' approval in Australia? Is it weeks away?
Well, an incomplete application. It’s not in the full final format so it's not a legally binding application yet, and this is quite normal. Companies do test the waters with FDA before they even go to Europe, never mind Australia.
So we’re expecting to get a full application in the coming week or two. As I’ve said, our team has got out of the shower and started to look at this, having finished with boosters literally at 6 o'clock last night. It will depend on quality of data but only just starting to look at because they only got the data.
So, it will take a few weeks but I would hope that we get there by the end of November but it really does depend on when we get the full application from Pfizer, the complete version, and if there’s any issues.
We also have to remember that FDA has not approved it yet. Their committee recommendation is made public. They have to look at it and then the Centres for Disease Control have to look at it in early November.
Minister, so we're heading towards 80 per cent of the population being double dosed. Is there a target as to how many of that you expect to get a booster shot? Are there any estimates set?
And also, given that the booster shots will be rolled out first to aged care, disability, given that there were issues getting them into those settings for the first vaccine rollout, what sort of lessons have been learnt from that to make sure that there isn't any sort of delays in terms of supply or getting numbers up when the boosters are?
Sure. The first thing is we don't want to put limits on the number of people to have first doses, second doses, or booster doses. And we want to encourage every Australian that is eligible to continue to come forwards, to complete their primary course, and when they are due, six months plus, to come forward for their boosters.
So, we don't want to put any limits on that. We want to encourage every eligible Australian to do so.
Then, I think that's the critical thing there, in terms of aged care, we went through. We were able to make sure everybody was vaccinated. The principle challenge was supply.
We have full supply and we’re already in preparation and planning to roll out. This time, there’s only one shot that’s required and there is a sort of an unconstrained supply. So, that's important and it follows the six months plus and we’re in a very strong situation.
Thanks for your question.
Professor Skerritt, just on mixing and matching, the messaging until now has been don’t mix and match. Now you’re saying if you’ve had AZ, you can get Pfizer. So can you just run through why that's okay?
And just secondly as well, with pregnancy, Pfizer has been approved and it’s safe for women that are pregnant. Is it the same with the booster shoot?
And to you, Minister Hunt, you said you expect population-wide, so aged 18 and up. In the US and UK, they’ve got specific groups, it’s not population wide. So why is it going to be different here?
And also, one more. Sorry, from Melbourne. On the tennis, I know everyone wants to know about the tennis stars. Are you comfortable with unvaccinated tennis stars coming to Australia if they complete two weeks of quarantine?
I'll let John go first. You got a lot of value for your money in that.
Gee, I reckon.
So, you asked about pregnancy, and there's been a number of studies now published on pregnancy and pregnancy outcomes. I think it’s about five or so now.
It's usual that, as every week goes by, there’s probably 10 papers published in top shelf medical journals on these vaccines so, our body of knowledge increases. So, those five studies have shown that there’s no impact on pregnancies with these vaccines and they’re recommended for use.
And so, there’s no evidence to suggest that a booster should be any different there. So, it won't be, to use a medical word, contraindicated in pregnancy.
On mix and match, we were cautious. Again, back in, I think I was asked at Estimates in June, and we were cautious because there had only been one or two studies and very little clinical observation.
Again, there’s probably now dozens of studies to show that actually mixing and matching- so, for example two AstraZeneca’s and then a Pfizer or even one AstraZeneca and a Pfizer gives a really good immune response.
And so, regulators worldwide in almost November, the end of October, are a lot confident about the value of mix and match than we were in May or June.
So in terms of the whole population, that’s the approval. And we’ve followed the advice on the approval. Obviously we’ll await the final advice from ATAGI but they've been working very closely with the TGA throughout.
And there’s a lot of engagement there. So, subject to the ATAGI advice, we’re ready to proceed. Israel has commenced that. I know other countries are considering in moving towards. I'm not aware of any other country that has commenced but I remain to be corrected on that. But certainly, we know that Israel has commenced.
What that would mean is that Australia would be one of the first countries in the world to commence a whole population booster program.
So we would have one of the highest vaccination rates, one of the most recently vaccinated populations, and one of the first booster programs, which means that we will be one of the most protected countries in the world.
In terms of the tennis, pretty simple position. And that is, you can come in if you’re double vaccinated. If a state is seeking an exemption for somebody to come in for a workplace program or a similar event, and they are unvaccinated, they can come in if that state seeks it.
And they are subject, however, to the two weeks’ quarantine and that's without fear or favour. And so then it’s entirely a matter for the state or the state working with Tennis Australia. And if there’s a no jab, no play policy in Victoria, that's a matter for them to resolve.
So, you have to do quarantine if you haven't been vaccinated. If the state wishes to seek the exemption for the players, not any one particular player, then that would be granted at the Commonwealth level on a major events basis but it would require the full vaccination.
Jade and then Sarah.
Will you make changes to allow pharmacies to administer their Pfizer as a booster shoot?
And also a question for Professor Skerritt. Will the process for assessing Pfizer for children be any different to the process for assessing Pfizer in adults?
So the answer is yes. We will be making Pfizer available to pharmacies and we will be making Moderna available to those GPs that wish to put it in place, particularly in some rural areas or more remote areas.
There’s an interest in Moderna for GPs. But precisely because at this stage there hasn't been an application and approval for Moderna as a booster, for the pharmacies that are operating the programs, we want to make sure that that's available.
On the process for Pfizer, as soon as any medicine or vaccine is proposed for use or applied for use in children, you obviously need to dig even deeper and I'm saying even because we look at safety very thoroughly for every age group, but we dig in even deeper for children.
And so, the trial data for children will be on more kids than say, on the booster. The safety monitoring has been for a longer period. We’re not seeing red flags there, I should say, but it's very early days yet.
But yes, we- and the other thing is that the application - again this is public knowledge - for the children is for a third of the dose, because they believe once you’re under 11, a third of the dose is just as good as- so it’s 10 micrograms rather than 30 micrograms.
So in that way, the process for kids is different, but the nature of the data is the same. And so far, it looks okay. But as I’ve said, we’ve only had it for a day.
Just on kids now, five to 11 possibly being vaccinated, do you ever see a situation where it will be no jab, no play?
We’ve got that for other vaccinations for children. Now they’re going to be able to get a COVID jab. How do you see that evolving?
Sure. So, no plans or expectations at this point in time and I think that's likely to remain the case.
Given that international travel is opening up, will there be a point in time in the future were people will need their booster to travel overseas and return from overseas?
Secondly, if I may, we are obviously moving on to boosters but the UN has said that, you know, developed countries should be prioritised- helping vaccinate poorer countries. Has there been an update on vaccination our Pacific neighbours?
Sure. Let me start with the Pacific. We are committed to 60 million vaccines as well as half a million dollars of, half a billion dollars of funding on that front.
The AstraZeneca is, was done with the capacity to vaccinate the whole of the Australian population twice and we always knew that if we had a spare of vaccines, we would be able to share them. And Fiji has been, as an example, very significantly vaccinated with Australian made CSL produced AstraZeneca vaccine.
And so we will continue to supply. We’re going to complete- make sure we complete that contract even though we have been supplying with all we need for Australia to meet our first and second doses with AstraZeneca. Part of our duty to the region is to continue to provide that. And we are engaged literally every day through the Department of Foreign Affairs and Trade with regional countries.
I’d just add, Minister, it’s not just the supply, although obviously the supply is central. We are also very actively involved technically in helping those countries work out how to administer the vaccine, how to store them, how to report safety issues.
And also, looking at a broader range of vaccines. And I actually have a team of people funded by the Department of Foreign Affairs and Trade that is providing technical support underpinning these tens of millions of doses that we are providing in the region.
So just in terms of international travel and boosters, again, at this point in time- as we’ve said throughout the pandemic, we have to review everything as it progresses and as the science evolves.
But the advice we have is that you would remain fully vaccinated with the two vaccines, and we’ll continue to follow the international science, but that is the requirement for international travel.
Thanks Minister. Just moving away from vaccines for a moment if I can, health groups, both national and international, are calling for more ambitious climate targets to protect Australians health saying they want to see health explicitly outlined in our climate commitments.
Does Australia's emissions reduction plan do enough to address the health risks associated with climate change and how much was health involved in developing that plan?
So the answer is, in my view, yes, it is a very important consideration and it was well considered. I was deeply engaged. The Department of Health was engaged. I was involved not just as a cabinet minister, but through the preliminary discussions.
Obviously, I have the current hat, but I had a previous hat having helped develop and lead Australia's position for the previous, for the previous international pledging conference, the Paris conference.
So health was deeply engaged and I'm very thankful to the Prime Minister and to Angus Taylor, the Minister for Emissions Reduction and Energy, for that, as well as industry.
And look, let me give you my personal view on this. This is a very significant moment in Australia, and it's a significant moment for a number of reasons.
One is it builds on what we did in Paris. In Paris, and some of you will have been in this room in 2015 when we announced it with then Prime Minister Tony Abbott and with Julie Bishop, and to go from minus 5 to minus 26 to minus 28 was a major step.
And many doubted that we'd be able to achieve 2020's Kyoto 2 target, let alone the Paris target. We've roared past 2020 and we did that without an electricity tax.
We're going to clearly meet and significantly beat our 2030 targets with the revised projections, and now we've committed to net zero.
And we were cautious in doing that because we didn't want to make a pledge which would either damage jobs or drive up electricity prices. But once we were able to see that pathway, Angus followed that same careful process of having worked it through. And so I'm really proud of the next evolution.
I think it's good for health. I think it protects jobs, and I think it's a great thing that Australia is playing this leading role.
The other thing I’ll mention, when you think of it as India over 80 per cent increase since 2005, China over 70 per cent increase, South Korea over 30 per cent increase. Canada is a minus 1 per cent decrease since 2005, New Zealand minus four. You have Japan and the US about 7 and 13 [sic -7% OECD, -10% Japan], I believe – I stand to be corrected. And then Australia and the EU are at minus 20.8 and minus 21, so we're almost identical in our reductions to the EU.
We are right at the global forefront of reducing emissions.
Josh? Sorry, that was, I'd been waiting my chance to say that.
Just two quick ones, one on the rapid tests. Will they only be available for purchase or will they be available for free at some point, like in the UK? And if not, why not?
And I guess on the boosters as well; as you've both said, after two doses, you're fully vaccinated. I think some people might ask, what's the point then of getting a third one? Is it just a peace of mind sort of thing?
Or will there be, I guess, at some point your full vaccination status kind of expires or runs out or something?
Sure. Do you want to go to the point of boosters?
I can do the booster one, if you want to the rapid test one, Minister.
So, while we've emphasised that two vaccinations is considered fully vaccinated, whether it be for entry to domestic venues or for international travel.
There's no doubt that there is some waning, albeit slower than perhaps some of the pundits have called it, there is some waning of the immune response, especially in people over 60, especially with those who have immunocompromises.
And so in those populations in particular, but again, if someone in the general population may- six, seven, eight, nine, 10 months later be getting a booster to just give them absolute coverage, not only against serious illness, but also against mild illness and transmission.
And those two things, while not life threatening, are very important for the economy and for returning to pre-COVID life.
So, the trick to the booster is in the name. It's a booster. It's an Olympic year - Citius, Altius, Fortius; faster, higher, stronger. It's additional protection over and above. Sorry, I've really taken to freelancing now.
But, you know, the booster is all about the name. It's perfectly titled. Extra protection. In terms of rapid antigen testing, the critical thing here is that currently we have trials which are underway where we've been providing support in aged care and we have suppliers which have been made available to certain critical user groups through the National Medical Stockpile.
But we're making it generally available and we'll let that market develop. And for those that have got the critical needs, we've been able to provide them.
It's not a replacement for the PCR, as John has been at pains to rightly point out. It's an additional support and an additional screening tool rather than a pure diagnostic tool. So they do serve those two different purposes.
I'll just finish with saying another important milestone today in terms of Australia's vaccination program, and the boosters will mean that we will be one of the most highly vaccinated societies, one of the most recently vaccinated societies. And as a consequence, one of the best protected societies in the world.
Take care everybody. Thank you.