Okay, well, welcome, everybody. And I’m pleased to be joined by Professor John Skerritt, the head of the TGA.
And Australia has one of the highest childhood vaccination rates in the world already, but it can go higher, and we want it to go higher. And as part of that, I’m delighted to be able to announce that we now have a double green light for the Moderna children’s vaccine, and this will be for six- to 11-year-olds. It will be able to commence as of tomorrow.
And significantly, and Professor Skerritt will take you through this in more detail, the important thing is it’s the same formula. It’s half of the adult primary dose, but it’s the same as the adult booster dose.
So, we have Moderna in over 4,000 points of presence around the country, and that will make it very easy for parents. And individual pharmacies or general practices, state clinics, or Commonwealth clinics will indicate when they’ve completed their training, and they’re ready to commence.
But from a national perspective, the program will begin tomorrow on the availability of individual pharmacies, GPs, state, Commonwealth, or Indigenous clinics. And I think that’s a really important step forward.
In terms of the children’s vaccination program, we’re at 49.4 per cent. But interestingly, we have had tracking on the intention until recently. And the figures I was able to indicate yesterday, we’re at 67 per cent intention. But in the absolute latest figures, that has increased to a 76 per cent intention to have children vaccinated in the sentiment tracking of parents.
And so, this is an important indicator. It means that the will is there, the access is there, now we have to bring them together. And that’s where having, in addition to the Pfizer, which is available for five to 11s, the Moderna for six to 11s adds additional choice, additional options.
In particular, Moderna has been widely used in the pharmacies. And for families, if they ring ahead to their pharmacy, and the pharmacy is choosing to provide this option, then that will really be an important step forward.
The next thing is, in terms of the boosters, we're now past 11 million boosters. We're at 62.1 per cent of the eligible population. And so, Australians are stepping forward. They're being boosted with the Pfizer and the Moderna, and we want to encourage them to continue to do that.
At a national level, we have also now reached 96.2 per cent of first doses and 94.3 per cent of second doses. What does that mean? It means as those numbers come through, more people will be boosted.
We've seen an uptake of about 12,000 Novavax so far, well ahead of what we'd anticipated in this time frame. And so that's providing an additional option for people who, for whatever their circumstances, may not have been confident or may not have been able to have taken one of the other vaccine options that's available.
With that, I'd also note that we've now passed 53.5 million doses all up across the country, and we've also now passed 82 million units of PPE that have been distributed during the course of this year alone.
I mentioned yesterday; case numbers are down by 90 per cent, and we've seen commensurate declines of 55, 60, and two thirds in terms of hospitalisations, ICU and ventilation patients. So good progress, but more to be done.
And I want to thank Professor Skerritt and the TGA. They've just worked relentlessly for two years, whether it's been across standards for masks, vaccines, rapid antigen tests, PPE, all of the different elements, the treatments and the therapeutics that have helped to make up Australia's response.
Thank you very much, Minister.
And confirming that approval of the Moderna vaccine and the positive advice from ATAGI recommending that healthy children can have two doses eight weeks apart. If the children need to travel or if they are immunocompromised, they can have it as soon as three weeks apart. So, the TGA advice and approval is for at least the three weeks apart.
So, it's something we're particularly proud of. Despite very carefully and in depth reviewing the data on Moderna, having two cycles of external clinical advice, the TGA is actually the first major regulator in the world to approve Moderna for six to 11s.
And we did it in collaboration with other regulators such as Europe, and we do expect other global regulators to follow soon. But I make pains to make that point, because even as recently in last week's media, we were criticised for Australia being slow to approve vaccines.
And whether it's the approvals of the vaccines or whether it's our rollout through the percentage now vaccinated, or the rate of paediatric rollout and so forth, we're actually world leading. It's very easy to throw cheap shots, but we are the world's first regulator.
As the Minister said it, the Moderna approval is in six- to 11-year-olds, whereas the Pfizer one is five to 11. That's merely the data that we received from the clinical trials that was done. There's nothing to be read into that other than clearly if we get data on six to 11, that's what we have to review and consider.
As the Minister said, it's a half dose of that used in adults, and it's actually the same dose used in boosters. And there’s a convenience factor in that a GP or a pharmacy, or a vaccination centre can use exactly the same vials for Moderna for the children, for boosters, and for the adults.
And as the Minister said, the training packages are being rolled out. It does bring an extra 1,600 sites nationally. There's 1,600 sites, some GPS and a lot of pharmacies who are set up to do Moderna, but not Pfizer.
So, it means that mum and dad can have their boosters and they can bring their primary school aged kids to have their jabs all in one go.
I just want to remind people of the importance of vaccination of children, because there's been a lot of talk saying: well, kids don't get very sick with COVID. You know, why are we exposing them unnecessarily?
And while the numbers are still being reviewed because of things like coroners and post-mortems, we believe in Australia there have been at least six deaths of children with COVID, a number more hospitalisations. And now somewhere between 150,000 and 200,000 children under 10 have caught COVID in Australia.
So that's a very significant impact. And also, the impact on transmission to parents and grandparents and so forth. There's also a serious condition that between 40 and 50 children in Australia have called multisystem inflammatory syndrome, and it's not long COVID. It's additional to long COVID and separate the long COVID. And these kids can be sick for months.
So, I get a little bit grumpy when people say COVID doesn't affect kids, it's just like having a cold. Luckily for many kids, it is fairly minor. But try telling that to the parents of those children who have become sick. So that's really important to emphasise that kids can get sick.
The other thing that we're very heartened by; now, of course, in Australia, there's been quite significant experience with 12 to 17s. We've had over 3.5 million doses. And of the Pfizer, we've already had about 1.1, going to 1.2 million doses in the under-12s.
The safety record of both the messenger RNA vaccines is quite impressive. Sure, there’s short-term reactions, and some kids end up having to, you know, go to bed early or have a sore arm or a headache or feel a bit of muscle pain. But the bottom line is that those effects are generally short term and self-limiting.
We know that there's been a very rare syndrome called myocarditis, an inflammation of a heart, in older teenagers and young adults. Even in the older and teenagers and young adults, it's quite rare.
You're looking at three, four, five for any age of cases per 100,000. And even for boys after the second dose, it's 10 to 13 per 100,000. So, it's still very rare. You've got to be unlucky one in ten- one in 20,000 if you present it a different way.
But really encouraging messages that in Australia, we have no reports that have been confirmed from our analysis of myocarditis in children under 12.
And the Americans who started the rollout of the paediatric vaccines in mid-November, when they did an aggregate analysis of their data, they have had a few reports, but it's like one in a million.
And we think that the hypothesis is it may be associated with puberty and sex hormones. And so, the safety profile of the vaccines, while impressive overall, is even more impressive for children pre-puberty.
And I know that as a parent, safety quite correctly is something that people will always think of. But we have tremendous experience now, both here and globally, and we can be very reassured.
Finally, I just want to mention two things: the importance of keeping up to date with that third vaccination, particularly with Omicron, and sadly, in Australia, we've now had more than two million people this year who have caught COVID and again heading towards about 2.7 million overall.
And we are concerned that many Australians are not taking up the opportunity to have that third dose of vaccine, despite overwhelming evidence that it does significantly reduce the risk of serious infection. And the challenge is that COVID reinfections can and do occur.
Now the statistics are coming through, and if you're asymptomatic or you have mild symptoms, it's probably an underreporting. But at least data from the UK shows about one in 24 people, at least who have had COVID will catch it again, and there's some recent data from other countries that are supporting that figure at about one in 20 to one in 30.
The message is you can have your booster shot or your third shot, as we call it, as soon as you recover from COVID. And we certainly encourage people to have it within four months of recovering from COVID, because any additional immunity you might get from having caught COVID does wear off.
So, my message is: if you've had COVID, don't lull yourself into a false sense of security. That third dose is important. Have it as soon as you recover. Talk to your healthcare professional.
Right. Thanks very much, John. Happy to take questions. If we can start on the left-hand side of the room as you're looking at the at the stage, please. And if you just identify yourself and let's begin.
Minister, you mentioned yesterday that there would be a task force about doing school vaccination drives for COVID. When would you expect a school-based vaccine program to begin for COVID?
And is there any target about where you would hope the vaccine rate for children would be should that program get up? And would that be just primary schools? Or would high schools be a part of that as well?
Sure. So, Professor Julie Leask is leading the work, one of Australia's great immunology experts, and in particular on vaccine programs and vaccination of children. She's working with the Commonwealth and the states.
We've obviously been working through COVIDShield with the states now for many months, and that's led to the rapid rollout of children's vaccination.
Our rate is one of the highest in the world, but we think it can and should go higher. Through the program, I've not put either a ceiling or a floor on the numbers, and that's hopefully helped us continue to drive up and up and up as we've gone to the 96 per cent rate for adults.
With children's vaccination programs, we're encouraging all states and territories to undertake this. They know how to do it. They're good at it. They do have additional capacity now that the pressure has come off in the state clinics.
And so those state clinics, and I know talking with some of the immunisers when I had my daughter vaccinated in a state clinic with her 16-year-old booster just a few weekends ago, they were saying they were keen to operate in the schools.
So, some programs have begun in some states where they're doing some school in-reach. But we'd like to see that program provided universally across the country, through the states, to the schools on the time frame that best suits them, but ultimately as quickly as possible.
Rob Scott from 7NEWS. Two questions, if I may.
The Productivity Commission will examine the merits of unpaid leave allocations for all workers who need to care for an older relative or friend at home. How important do you think that is, and do you think it should be implemented? What's your stance on that?
And secondly, in Melbourne, primary school aged kids in years three to six are still being told they have to wear masks while most other people aren’t. What do you think of that?
So first, in terms of the Productivity Commission, this is exactly why we have an independent productivity commission. So respectfully, I’ll not pre-empt them.
But we had the Productivity Commission review into mental health and that played a huge role in framing our national mental health plan and suicide prevention plan.
So, what I would do is point to the way in which we responded to the last major Productivity Commission review into health.
In terms of masks for primary school aged kids in grades three to six, Victoria, I respect has taken a different path to, as I understand, the position in New South Wales and Queensland, for example, and I know for many parents, this will be difficult.
So, I'll leave that as a matter for Victoria. But the fastest way out is to have a school-based vaccination program. And if this is about vaccination rates, which, as I say, are some of the highest in the world, then the best way to turbo charge those school-based vaccination rates is with a school-based program.
A couple of questions for Professor Skerritt, actually. Are you considering Novavax as a booster shot at the moment?
And secondly, I'm hearing a lot of concern from parents about the lack of long-term safety data for vaccines. I know you've spoken about it before, but could you just go through those concerns again, please?
Well, firstly, Novavax as a booster and also for children, we have been talking very closely to Novavax as leadership here in Australia, and more broadly.
We are expecting to receive initial data. They have put out data by press release, but we don't regulate by press release. We're expecting to receive initial data from them next week.
They expect to provide the final data during the month of March, and I can't predict whether that’s middle or end. We will look at that as a priority as we have, and I mentioned the priority we took from Moderna. So, during March, I'm expecting to get that data and we will review it as soon as possible.
On longer term safety data, I think it's important to emphasise two things. Firstly, if rare but serious adverse events occur with vaccines, and this is almost a statement for every single vaccine, they tend to appear within one to two to five to six weeks after vaccination.
That's different from medicines, because remember, with the vaccine, you have a single one, two or three shots, whereas a medicine, you take it every day, many of them, and it could be a cumulative effect.
We now have had vaccinations in this country for over a year. We celebrated the first anniversary about earlier this week, and we've had vaccinations globally since late 2020, and indeed, I think we've now crossed 11 billion shots globally, maybe heading towards 12.
That's one of the largest data sets, to sound like a scientist, on safety that we've ever had on any vaccine. And we know that there's some rare things, like the rare clotting syndrome with AstraZeneca, like the rare, in Australia, certainly, and in the US, non-fatal myocarditis syndromes.
So, I think that’s a very commanding dataset, when you’ve had more than 10 billion, heading towards 12 billion doses.
So, I do push back when people say: look, we need five years of experience. Because the other thing, it’s a bit counterintuitive. How do you get five years of experience if you’re not rolling out a vaccine?
And we would’ve been in a lot worse place if we’d said: well, we’ve got COVID, we’ve got these vaccines, but we’re not going to use them for a few years.
What sort of consultations and preparations are being made with the AEC ahead of the election to keep it COVID-safe? Will we see things like special polling stations and is there a concern that cases might increase around that time as we start to head into winter?
Sure, so two things. I think it’s a really good question, thank you.
Firstly, the Special Minister of State, Ben Morton, is leading that process. So, I know that the AEC is planning for this.
But we saw a dress rehearsal, as it were, with the New South Wales by-elections conducted very carefully.
We know that in Australia there is a widespread use of both pre-polls and postal votes. And that has accounted for, in some electorates, up to half of the vote, and I know it was in my own electorate of Flinders.
And so, it’s likely that the nature of pre-polling and postal voting will spread out the load, rather than having large, concentrated crowds. And people have learned to distance, they’ve learned to keep space. Australians are now very prepared and well versed in the processes.
So, the AEC is making sure that conditions are as suitable as possible. And then, the best protection, of course, is the booster, exactly as Professor Skerritt set out.
So, the more people who are boosted, the better. And at this stage we’ve had over 62 per cent of Australians, so approaching two-thirds of Australians and those numbers are still increasing by well over 100,000 every day in terms of just the boosters alone, and I think that’s a very important thing.
And for those that haven’t been vaccinated, if you’ve been waiting for Novavax, Novavax is here, and please join all of those other Australians that have had their vaccines.
Thanks, Minister. Just a couple for Professor Skerritt.
Just the reporting in the last few days that the FDA is looking at potentially authorising a fourth dose of COVID. Is the TGA looking at that? How does that work? Do you kind of just look at what the rest of the world is doing?
And secondly, if I may, I asked the Minister about this yesterday, Sinopharm is a recognised vaccine by the TGA in people under 59, but people over 59, it’s not.
And there are some overseas who have got two doses, or maybe actually turned 60 in the time they’ve been overseas who now can’t get back into Australia. Is the TGA reviewing that or what are we doing?
Ok, so on the first point, nationally, we are looking at, and this is a broader effort across the Health Department and together with Ministers and government we are looking at Australia as we move into the flu season in winter.
We are aware that the last two years, because of masks and perhaps because of isolation from the rest of the world, we’ve had fairly extremely low flu numbers, and that’s not going to continue forever.
So, flu and COVID as we move into winter is something that is being looked at. And whether vulnerable populations would require a fourth dose, especially if they were boosted in November, December 2021, or into January 2022.
So, there’s a lot of active thinking and planning going on there, and that’s good. It’s only the middle of February now, but we realise as we get to March and April, we have to have clear positions on that.
With the data on Sinopharm, the level of protection for those over 60, from the data that we were given, was just too low to be confident.
Now, of course, is it not a bar for people to travel into Australia. There are arrangements for quarantine and so forth for those who have not had a recognised or approved series of vaccinations.
We continue to work with Sinopharm, and indeed other companies, as other Chinese vaccine manufacturers. And we approach them for the data; we look at data in the published clinical literature, but we can’t create data from thin air.
So, we’re continuing to chase those companies as well as to look at the international literature. But at the moment, the reason for Sinopharm above-60s was merely because the protection levels were not adequate.
Okay. Next please.
I’m Steph Dalzell from ABC News.
Professor Skerritt, I also have two questions for you, keeping with the theme. Just firstly, can you give us an update on where we’re at for vaccines for six-months to four-years, noting that Pfizer’s applied in the US?
And just secondly, when Novavax was made available you were kind of hoping that that might boost the overall vaccination rate, have you seen that materialise?
Well, I think to answer your second question first, the Minister’s already quoted some encouraging statistics of people coming forward, and I think particularly in Western Australia there’s been good uptake of Novavax.
So, you know, whether it nudges, you know, 95 to 96 or 97, or 94 to 95 to 96, we don’t know. It’s widely available, but we are seeing that there are people who are coming forward for Novavax who had chosen, for whatever reason, not to be vaccinated earlier and that’s encouraging.
On the under-four-years-old, FDA has actually put on ice, I think is the best way to say, their review of the data. They were going to have a committee meeting last week to look at it. But it is clear that especially for certain ages in that band, there's the need for either a third dose or a higher dose than that used by Pfizer.
And so, Pfizer are now conducting some further trials, so we're not expecting that FDA will complete their review for a couple of months now.
Again, it's up to the company, but I'm not expecting that other regulators, including us, will get submissions for the under-fives until well after Easter.
Minister, the Aged Care Royal Commission recommended the Federal Government should consult with the aged care industry to come up with a joint position on the work value case in the Fair Work Commission.
Unions and providers did that but said that the Health Department was invited to attend but declined.
At what responsibility do you take for the workforce crisis in aged care, given the Health Department wasn't even in the room to hear what the industry needed in terms of support in that case?
Well, with great respect, I've been part of discussions. Richard Colbeck has been part of discussions. There have been multiple discussions, so that statement is incorrect in terms of our engagement with unions, in terms of our engagement with providers. And that's ongoing.
We meet weekly with them, we discuss workforce and we're providing all of the material which the Fair Work Commission has been seeking.
The other thing is this of course, we've put in place $17.7 billion of response to the Royal Commission at last year's budget and another $600 million at the economic update, or what's known as MYEFO, the Mid-Year Economic Fiscal Outlook in December.
So, all up $18.3 billion of response to the Royal Commission. And we've gone from a position of $13 billion to more than doubling the annual investment in aged care.
So, we're, you know, increasing that support continuously. We are looking forwards to change what's known as the Australian National Aged Care Classification System, which will bring the additional care minutes up to 200 per person. And that will lead to a further very significant investment of over $3 billion in care needs and therefore payments for staff.
In terms of the staffing, we’ve provided (INAUDIBLE) of surge support across a variety of different sources. We’ve brought in returning and retired staff who’ve come back. We’ve assisted with the ADF, and we’ve been able to invoke the private hospitals guarantee to assist.
At this stage, the number of positive staff, the latest data I have is 1,558 which is well below one per cent of the workforce. And so, we’re working every day with individual providers to ensure that they have adequate staffing.
And we’re meeting in a formal way every week with providers and with staff to look at the systemic positions. So, it’s been probably the thing that we’ve spent the most time on right across the pandemic.
The statement that the health department declined to attend those consultations, that comes from aged care providers and unions’ joint statement in the Fair Work Commission work value case. Are you saying that they misled about the extent of consultation about whether you would join that case?
What I can say is that we’ve had multiple discussions.
Now, as to whether it’s a particular meeting in a particular place, I can tell you we’ve had multiple discussions in relation to staffing, workforce, Fair Work Commission, I can say this because I’ve had discussions myself about Fair Work Commission in the roundtables that we’ve held.
And so, there are multiple channels on a daily basis, on a weekly basis, and continuously.
So, I can’t speak to that particular submission because that’s one from those people. But I can say this is something we’ve engaged on, and indeed we have engaged specifically and appropriately with the Fair Work Commission.
And it’s appropriate for them to make their own submission, and I think everybody has (INAUDIBLE) on that front.
Just a question for Professor Skerritt. Just pulling on all the other questions, you’ve spoken about the data from Novavax you’re expecting in March; you’re looking at fourth doses. Just in terms of COVID vaccines or testing or anything, what is under consideration that you still haven’t ticked off yet with the TGA?
Well, there’s what’s known as provisional designation where we get a request, and we can approve that they can make a future submission.
So, there’s the Australian-made vaccine, the COVAX from Professor Petrovsky, that we’re expecting to get data soon.
We also have vaccines from a couple of international companies that we’re expecting to receive submissions from. And of course, we continue to review a number of treatments.
Rapid antigen tests are an active area of work, even though we now have, if you include the point-of-care and self-tests, we now have almost 50 approved.
A particular area of interest there are tests that will do both COVID and flu, because it will be important especially in some cases such as with the elderly, to work out whether, say, an elderly and frail person suffering significant respiratory symptoms, because there is a similarity in some ways, is actually infected with COVID or flu, because obviously it affects whether they get one of the COVID treatments, or there are also flu treatments.
So, as the Minister said, we’re not exactly resting in our laurels. It’s still going to be a very, very busy year, 2022.
Great. And then up the back, please?
Professor Skerritt, the use of rapid tests is keeping the economy open, getting people back to school. Is part of the weakness of the system the clinical data backing up the effectiveness of the rapid tests, and is it correct that the TGA is relying on the data provided by the manufacturers rather than completing their own reviews of the effectiveness?
No, look, we do both. And of course, I should mention we have a significant team of expert professionals in this area, so we don't rubberstamp and just believe everything we're told by manufacturers, much to their frustration.
We have a team of people with many years’ experience and looking at rapid tests for all sorts of things who scrutinise the data very carefully and ask a lot of questions.
We also look at other international experience on those tests. We are working together with the Doherty Institute on a process of post-market validation of some of those tests.
So as the weeks go by, we will be increasingly going through each of those rapid tests that are on the market and checking that the manufacturers claims are also met.
So, it's what we call pre-market, where we scrutinise the data carefully, and post-market validation where we actually take these tests in the laboratory. You might ask, saying, well, why didn't we do all the post-market validation beforehand?
Well, it would have led to delay of two to three months before any of the rapid tests were available in the Australian market and no regulator globally went through a process.
The FDA are doing a similar thing, and we're exchanging information with FDA. They've also got the National Institutes of Health working on testing the tests.
Is it possible that some tests could be removed from market after the (INAUDIBLE)?
Yes. I mean, if the test clearly hadn’t met what they said the test did, we’ll take regulatory action which could range from either downgrading the specificity and sensitivity data through to withdraw from a market.
I wouldn't want to pre-empt that because we'll obviously look at that as we come. I think the Minister had a comment.
So, just two things. Firstly, I think that in terms of best practice, the combination of doing the data review and doing the validation sits at the absolute highest levels of global best practice.
And last time I spoke with John about this. Australia had actually, through the TGA, approved more tests than the FDA counterpart in the US.
But the other thing is, an interesting example, Tom, is that, and that the TGA looked at some of the manufacturer's data in relation to the Innova product. This was subject to a Class 1 recall, risk of serious illness, injury or death in the United States. And it's still yet to be approved.
It's the very test which Mr Albanese was referring to, I think quite irresponsibly. In Australia, it's marketed under the rapid test and track brand, and he was talking about hundreds of millions that could be brought into Australia immediately. It didn't meet the TGA standards.
And for the Leader of the Opposition to be spruiking a test which has not met the TGA standards, which has not met the FDA standards, was, I think, utterly irresponsible.
Having said that, I think today is another important day where the TGA and ATAGI have done their work, have shown a vaccine that has met the standards.
It's safe, it's effective, it can help protect children, and I am delighted today that what we have is the Moderna vaccine that will be available as of tomorrow, depending on the circumstances of the particular vaccination clinic for 6 to 11-year-olds.
And if your child hasn't been vaccinated, this is another important opportunity. And if you haven't had your booster or your first or second dose, please continue to come forward.
Thanks very much, everybody.