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Community Affairs Legislation Committee
06/04/2022
Estimates
HEALTH PORTFOLIO
Department of Health

Department of Health

[09:04]

CHAIR: We now welcome Senator the Hon. Anne Ruston, representing the Minister for Health and Aged Care and the Minister for Senior Australians and Aged Care Services. I also welcome the Secretary of the Department of Health, Dr Brendan Murphy, and officers from the department. Minister or Secretary, would either of you like to make an opening statement?

Dr Murphy : No, Chair, but Professor Kelly has a brief opening statement on the changing posture in COVID management since that's going to be very relevant to today's discussion.

CHAIR: Thank you. Professor Kelly.

Prof. Kelly: Thank you for allowing me to have the opportunity to make an opening statement. That will be circulated to the secretariat shortly. As this committee would be aware, the national cabinet met last month and agreed to take a nationally consistent approach to managing both the COVID-19 pandemic and the likely co-circulation of influenza over this year's winter season. The approach agreed by the national cabinet is aimed at minimising the health impacts whilst also supporting the economy. Although it is difficult to predict the scale in which this likely co-circulation may occur, national cabinet's approach assumed the possibility of significant outbreaks of both COVID-19 and influenza in the coming months, essentially a worst-case scenario.

The Australian Health Protection Principal Committee, the AHPPC, which I chair, subsequently met face to face for the first time in a year to discuss the outcomes of the national cabinet meeting. I'd like to put on record that the discussions at that meeting were both open and collegial and, pleasingly, there was a very strong commitment to national consistency.

As Australia enters the final phase of the national plan to respond to COVID-19 and as we start to live with the virus, the 2022 winter season may well present challenges to health systems, healthcare providers, aged-care and disability care residents, communities and the economy.

I can report to the committee that, despite the current increase in the COVID-19 numbers which is related to the BA.2 variant, Australia's health systems are coping well. Despite the continuing cases, mainly in younger people—children, adolescents and their parents—the common operating picture has remained green; that is, the report we receive and circulate publicly every week on the health sector preparedness and its response to COVID.

Increasingly, the predominance of the omicron BA.2 variant of concern, resurgence of omicron BA.1 and the emergence of a new COVID-19 variant are all possible scenarios in the coming months. Again, I would like to reassure the committee that, as a country, we are very well prepared to respond to any of these scenarios.

Work is well underway in all states and territories, supported by the Commonwealth, to prepare our healthcare system for the likely co-circulation of COVID-19 and influenza. The AHPPC is currently finalising its advice about how to implement the approach agreed by national cabinet. But the general principle will be to move away from reducing COVID-19 transmission to protecting people at higher risk of developing severe disease, essentially reducing harm. The focus will be on supporting normal community functions and minimising disruptions to our health system and society.

Why are we changing this approach? The reason is that we are at a vastly different space to where we were at the start of the pandemic. Our extremely high vaccination rates, particularly for people aged 65 and over, coupled with the recent availability of effective treatments, mean that we can shift the focus away from reducing transmission to minimising harm from COVID in our most at-risk populations, for instance, the elderly and those with underlying health conditions.

As part of this shift in focus it is important that everyone continues to do all the good things that we have done to combat the spread of COVID-19, because many of those will also assist with preventing flu transmission. That means continuing to observe safe hygiene practices, getting tested and isolating if you have symptoms, and making sure that you remain up to date with your COVID-19 vaccination, getting a booster and a winter booster when you become eligible.

I would like to turn now to the uncomfortable but important topic of COVID-19 associated deaths. At the outset I want to acknowledge that every death statistic is actually a person, and they all have families, friends and loved ones. For those friends, loved ones and families, this is always a difficult time. I am very mindful of the sensitivities associated with citing death data, but the reality is that the lives of many thousands of Australians have been saved because of the measures that were put in place to respond to the pandemic. This is an indisputable fact.

If we look back to early 2020—if people remember—many other countries around the world, including Italy, the UK and the US, had overwhelmed healthcare systems and extremely high levels of death. As a personal anecdote, my sister lives in a small village in Italy. She has experienced through the multiple waves that Italy has had in that small village the terrible toll in death in that small village, to the point where the bells in the church signifying yet another funeral sometimes go all day from dawn until dusk. We have not seen that in Australia, and I have no expectation that we will see that in Australia.

Of course, as we all know, back then in 2020 there were no vaccines against COVID-19, nor were there effective treatments that exist today. We need to move away now from counting the number of people who die from COVID-19 on any one day towards a concept known as excess deaths. In simple terms, this can be seen as the difference between the number of people you would expect to die over a given period of time—for example, a year—as a result of a particular event, such as a pandemic, and the actual number of deaths recorded from all causes. On this metric Australia has performed extremely well throughout the COVID-19 pandemic. Were it not for the measures that we put in place, from closing our international borders to social distancing, mask-wearing et cetera, tens of thousands of additional Australians would have died from COVID-19.

According to the Lancet journal, one of the premier medical journals in the world, Australia was one of just five countries—the others being Iceland, New Zealand, Singapore and Taiwan—to record what is called a negative excess mortality rate due to COVID-19 in 2020-21. What that means is that in Australia, along with those other four countries, fewer people died of COVID-19 in 2020-21 than was expected. Again, although every death from COVID-19 is a sad event for family and friends and as a country, this is an outcome we should acknowledge.

While there may be challenges ahead, I see no reason why, even with the easing of restrictions we are now enjoying, the strong position in Australia is likely to change over the winter months.

I would again like to stress that the best protection a person can have against COVID-19 and the flu is vaccination. More than 95 per cent of the eligible population in Australia have had two doses of COVID-19 vaccine, as General Frewen reported on Friday. Almost 70 per cent have had a booster. For over-65s—the more vulnerable age group—the news is even more remarkable: extremely high rates of booster vaccines and now, from Monday this week, the availability of a winter dose, a fourth dose, for most in that age group.

Australia ranks fifth among OECD countries for both people who are fully vaccinated and the vaccination of children five to 11. Australians in vulnerable populations are now able to receive their free flu vaccination through the National Immunisation Program. I would encourage those people to make a booking as soon as possible and, if possible, to get their winter COVID-19 booster at the same time if they are eligible and haven't yet received it.

Just finally, hot off the press from another of our premier medical journals, the New England Journal of Medicine yesterday published real-world information from Israel showing the effectiveness of a fourth dose in older people—3.5 times more protection against severe disease in that elderly age group. I encourage anyone who is now eligible for that fourth dose or winter dose to go ahead and get it as soon as possible.

[09:14]

CHAIR: Thank you very much for that. That has been tabled and circulated so everyone's got a copy of it. The first item on our schedule for the day is whole-of-portfolio and corporate matters. My understanding is that there probably aren't any questions to be fielded in that area, so we might move straight on to outcome 1 with regard to health protection and emergency response regulation and the immunisation programs. There's also TGA and Office of the Gene Technology Regulator. We will move straight on to that. I give Senator Grogan the call.

Senator GROGAN: Just picking up on the OECD numbers you were talking about, when we met on Friday you took on notice where Australia ranked in terms of booster doses in the OECD. Do you have that figure?

Lt Gen. Frewen : As to the figure that the OECD uses, we are currently ranked 22nd in the OECD. But I will highlight that the figure doesn't compare comparable systems. It's sort of an apples and oranges approach because each country has a slightly different set of requirements around how it applies the boosters—different age categories, different frequency and the like. We also started the booster rollout a bit later than many of the countries that are currently rated above us, so we think we will move up those rankings. What is most important right now is that, regarding our most vulnerable—our over-70s—almost 90 per cent of over-70s have already had their booster. In aged-care residential facilities, where our most vulnerable are, over 94 per cent of people have had their boosters. In the over-60s we're at around 85 per cent. In the over-50s we're even in the 80th percentile as well. So in the most vulnerable cohorts for boosters, I think we're very well-advanced.

Senator GROGAN: We're fifth in terms of the OECD, in terms of two doses administered?

Lt Ge n. Frewen : Yes.

Senator GROGAN: And 22nd in terms of booster?

Lt Gen. Frewen : Yes.

Senator GROGAN: That's quite a gap.

Lt Gen. Frewen : Originally, we were much lower down the OECD rankings for two doses. As our rollout has proceeded, we've climbed right to the heights. I think we will see that through the booster program as well. As I've said, in the eligible percentiles, for which we don't have the comparative analysis, we're in the 90th percentile range for the over-70s.

Senator GROGAN: We're effectively behind because our rollout was so much slower?

Lt Gen. Frewen : In terms of when we started our booster program, we did start later than some of those other countries who had started their rollout earlier than us.

S enator Ruston: It's probably worth clarifying here that somebody becomes eligible for a booster at a certain period of time after they've had their second dose. I think what Lieutenant General Frewen is saying is that we are on track for the very high rate of vaccinations, including boosters. It's moving along as it should do. I don't think there's anything negative about this. I think this is a very good story, in that we are on track to make sure that Australians are receiving their boosters at the time that they are due and reasonably should be taking their boosters. There is no problem with the booster rollout.

Senator GROGAN: It's just that our initial vaccination program was slower than many other countries, so we started lower down that ranking, and we've built to five in the double vaxxed.

Dr Murphy : It was only slow, Senator, because we waited for the full TGA approval of all of our vaccines. We didn't start with emergency use authorisation because we were in a very good epidemiological situation. We took the decision that we would get full TGA registration, and go through the full assessment process. Countries like the US and the UK, because people were dying every day, had to use emergency use, but we went through the full assessment process of a vaccine. That was a deliberate decision to start later. I think we saw with the AstraZeneca vaccine that we were able to pick up some of the issues with it and modify them earlier. It was a deliberate decision to do it carefully and differently.

Senator GROGAN: I think that does tie in to what Professor Kelly was saying, in the sense that there were people dying, and each of those individual deaths is a tragedy.

Dr Murphy : Correct.

Senator GROGAN: So, sure, we may not have had quite as many people dying as in other countries, but I don't think we should dismiss it as being an irrelevant point.

Senator Ruston: Senator, having listened to the comment that the secretary just made, I don't think anybody is dismissing any death in this country. Obviously, every death is a tragedy, and these people have worked tirelessly for the last two years to make sure that they balanced everything so that they could keep all Australians as safe as possible. I would suggest, on behalf of the officials, that I would take offence at thinking we were in any way dismissing a death.

Senator GROGAN: No. Professor Kelly gave a very good summary earlier this morning. I think some of the government decisions about where we were going with the rollout of the booster and the ability to obtain the vaccinations made us slower in rolling out the protections than we should have been.

Dr Murphy : I would dispute that, Senator. As I said, we made a deliberate decision to take a full and careful regulatory assessment of every vaccine. We didn't start giving any vaccines under emergency use with the minimal data. We waited until we had proper data and our TGA process went through. That's why we started in February, when December and November were when the US and the UK started. But they started because at that time they had thousands of people dying every day. At the time we had very few deaths. We had very good disease control at the time of the commencement of the vaccine rollout.

Senator GROGAN: I think it's been well documented that our ability to obtain various vaccines, PPE et cetera was slower than would have been ideal to roll out; hence the coining of the term 'strollout'.

Dr Murphy : We reject that term, absolutely. There was plentiful AstraZeneca vaccine, which was our main vaccine, and we purchased that on the basis that we had local, plentiful supply. There was clearly an issue with the restriction in the use of AstraZeneca vaccine that did lead to a period when we had to bring forward some more mRNA vaccines, which we did. But the planning, under the guidance of Scientific and Technical Advisory Group, was focused very much on getting a plentiful and redundant supply of locally produced vaccines, which we did. Sure, the AstraZeneca issue was a bit of a curve ball in the rollout, but we compensated for that and pivoted.

Senator GROGAN: On a side point, there's been some commentary about the AstraZeneca vaccine waning faster than some of the others in terms of its ability to protect. Do you have a sense of that? I read it in the paper, and it piqued my interest this morning. Could you give us any further information?

Dr Skerritt: The vaccines are all a little bit different in how they stimulate the immune system to protect against COVID. The antibody response to the AstraZeneca vaccine, two doses without a booster, does drop off faster than the antibody response to the Messenger RNA vaccines. However, some other studies have shown that the other arm of the immune system—the cellular immune system, T cells and memory cells—actually seem to be maintained better with the AstraZeneca vaccine than the Messenger RNA vaccine. It's not just about antibodies in protecting you from COVID. There are several parts of the immune system, and some vaccines are stronger at one part and other vaccines are stronger against others. This is why, of course, we're encouraging people to have a booster. Two AstraZenecas followed by a Messenger RNA booster is actually a very good pathway towards protection from serious disease or death.

Senator GROGAN: Thank you. How many Australians are overdue for their booster?

Lt Gen. Frewen : We have 2.14 million people who are overdue for their booster. That's about 11.2 per cent of the eligible people.

Senator GROGAN: How many of those are over 65 or immunocompromised that haven't—

Lt Gen. Frewen : I'd have to take that on notice, Senator, but I can reiterate what I said before. In terms of boosters, in the over-50s, 82.9 per cent of people have had their boosters. In the over-60s, 86.5 per cent of people have had their boosters. In terms of the over-70s, 88.9 per cent of people have had their boosters. In residential aged-care facilities, 94.2 per cent of residents have had their boosters. Booster take-up rates in the over-60s are very strong.

Senator GROGAN: Where's the discrepancy? Who's not taking it up? We talked last week about—

Lt Gen. Frewen : It's the under 40s that are over-represented there.

Senator GROGAN: Why do you think that is?

Lt Gen. Frewen : There is a range of reasons that we've spoken to before, Senator. I think there are both elements of some confusion and elements of some complacency around the rollout in those age groups. People are no longer as fearful of omicron as they were with previous variants. People have had it and have moved on, and thought, 'No big deal; why bother getting a booster?' Some people are still confused about, when they get it, if they've had COVID. There's a myriad of reasons.

Senator GROGAN: We talked a little bit about the booster campaign on Friday. How is that targeting that particular element of the population that seem to be slower to come on board?

Lt Gen. Frewen : In the broad sense, those ads are really about reminding that age cohort that their social life, fitness routines, their businesses and all of those things are underpinned by the maximum possible take-up of vaccines, including boosters. I can get our communications person to speak to that in more detail, if you'd like, Senator.

Senator Ruston: The point here, though, is that this is a choice for Australians. Certainly, we are not going to force Australians to have a booster. Clearly, we want to make sure that they have the information so that they understand the benefits to themselves, their families, their communities and their employment of being protected from COVID.

CHAIR: Senator Rennick has the call.

Senator RENNICK: Is the Office of the Gene Technology Regulator here?

Dr Murphy : We've got Dr Bhula here, Senator Rennick.

Senator RENNICK: Just as a starter, I thought I'd ask: what exactly is the role of the Office of the Gene Technology Regulator, and how do you work with the TGA with medicines and drugs that involve gene technology?

Dr Bhula : Thank you for your question, Senator. The Office of the Gene Technology Regulator is responsible for authorising all activities with genetically modified organisms and some of the techniques that go with developing genetically modified organisms. In terms of our interface with the TGA, we are responsible for the authorisation of research activities. Most of our research stakeholders involve hospitals, clinical settings and universities. The other side of it which is not TGA related is to do with agricultural cropping and genetically modified crops.

With the TGA, there is a little bit of overlap in terms of commercial therapeutic GM products, but that's something that we're working through in terms of streamlining, through the third review of the gene technology scheme, and a number of recommendations in that review.

Senator RENNIC K: I note that obviously the COVID vaccines had gene technology in them. What role did the Office of the Gene Technology Regulator play in reviewing the safety of those vaccines?

Dr Bhula : We don't actually review the safety or the efficacy of any therapeutic product. That's the role of the Therapeutic Goods Administration. Our role in terms of the risk assessment is limited to looking at the containment of the genetically modified organism. With most of the vaccines being an AAV, a virus, within the vaccine we look at the people that are working with and administering the vaccine. If it's imported, we look at the authorisations for import, storage, transport and disposal. Our role in terms of the assessment is fairly limited, to just looking at the environmental risks and making sure that the GMO has been handled correctly through all of the stages up to administration into a patient.

Senator RENNICK: My concern is that, given these vaccines have used gene technology for the first time, there's a gap in the regulation of the gene technology. And I ask that because we put in a freedom of information a few months ago about the genotoxicity of the vaccine, and the reply that the TGA gave back was that they hadn't reviewed documents relating to the genotoxicity. Professor Skerritt said last week that may be commercial-in-confidence. I would have a problem with that if that was the case because safety data shouldn't be commercial-in-confidence at all. What I want to know is: who's responsible for the safety of gene-coded products, medical products?

Dr Bhula : To go back to the start of your question, a number of vaccines that contain genetically modified organisms have been registered through the OGTR for a number of years, not so much in terms of human vaccines but a lot of them for animal vaccines. A number of vaccines have been approved for vector control so treatment of malaria, Ross River virus, dengue and that kind of thing. This is not new to the Office of Gene Technology Regulator.

Senator RENNICK: With that in mind—

Dr Bhula : Coming back to the genotoxicity question, that's entirely a question for the TGA.

Senator RENNICK: I'll wait for Professor Skerritt to come up. In regard to the trial of Pfizer, the initial biodistribution studies were done on animals, and those biodistribution studies showed that lipid nanoparticles went to a lot of the organs in the body; they didn't just sit, say, in the deltoid muscle. Secondly, they didn't use the active ingredients in the test. They used siRNAs instead of the actual mRNA-indicated spike protein. I'm curious to know: were any trials done on animals prior to the rollout of the vaccine on biodistribution studies in human beings with the active ingredient mRNA?

Dr Bhula : I'll just clarify for you that the mRNA vaccines are not required to be regulated through the Office of the Gene Technology Regulator.

Senator RENNICK: That's fine. That's why I've asked Professor Skerritt. My confusion is where the responsibility lies as well. If it is the TGA, that's fine.

Dr Skerritt : The dose of the lipids in the vaccine is below the threshold that internationally is assessed for genotoxicity and carcinogenicity. These lipids are commonly used in a range of other human therapeutics and even at higher levels there isn't evidence of—

Senator RENNICK: I accept that. But the lipids carry the active ingredient, which is the mRNA.

Dr Skerritt : Correct, yes.

Senator RENNICK: There are two issues. That's fine. I'm not saying the lipids themselves are toxic. Some people suggest that, and we can have that discussion another day. My first concern is the distribution of the lipids and nanoparticles throughout the body because they are carrying the active ingredient which is the mRNA—

Dr Skerritt : And they are distributed through a range of parts of the body, as are lipids that you have if you had a sausage or a steak for breakfast.

Senator RENNICK: Yes.

Dr Skerritt : And the lipids are hydrolyzed, destroyed by the body fairly rapidly, as are dietary lipids.

Senator RENNICK: You accept that these lipids and nanoparticles carrying the mRNA can go to other organs in the body? Let's say the heart, for example?

Dr Skerritt : They can go around the body, but no evidence of any ill effects.

Senator RENNICK: There was no evidence that the heart cells, for example, didn't take up lipids or nanoparticles carrying the mRNA and then the heart cells didn't start expressing a spike protein, thus inducing the immune system to start attacking heart muscles?

Dr Skerritt : There is some evidence that the rare situation of myocarditis, a known adverse effect—rare but known—does have a potential basis in an immune reaction affecting the heart. And we do know that any medicine is distributed around the body but then rapidly broken down. So there's still a lot of both fundamental and clinical research going on to look at the mechanism of myocarditis in response to the mRNA vaccines. But one of the other questions, of course, with anything that is rare is: why do those individuals have that event? Why is it more prevalent with particular ages? For example, young children seem to have extremely low case of myocarditis. There seems to be a peak around in young men and older adolescents. So there might be a testosterone relationship as a male. All that research is actively underway, but clinical—

Senator RENNICK: And this is my point: why hadn't this research been done prior to—

Dr Skerritt : If you'd wanted a couple of million people in Australia potentially hospitalised and killed from COVID, you could have had that, because this research takes a couple of years to do.

Senator RENNICK: Well—

Dr Skerritt : Sorry, if I can finish my answer. In order to understand these things it would have been another year or two or three until these vaccines would have been released. I think Professor Kelly eloquently described the impact of vaccines in this country. There is always going to be research on issues that emerge.

Senator RENNICK: And that's a separate issue.

Dr Skerritt : And, of course, myocarditis—

Senator RENNICK: I'm not talking about the risks of COVID here. I'm talking about the risks of the vaccine and there is quality assurance that needs to be complied with. I should also ask—

Dr Skerritt : No, the two are totally connected.

Senator RENNICK: I accept that. If you want to look at the actual risk-reward benefits to younger people, there are a lot of younger people that have had severe vaccine injuries that are going to impact them for the rest of their lives. The relative risk to young people of taking a vaccine—

Dr Skerritt : I disagree—

Senator RENNICK: Like myocarditis—

Dr Skerritt : I disagree with your assertion.

CHAIR: Let the question be asked and the question answered and then we'll clarify it.

Dr Skerritt : That would be good.

Senator RENNICK: I want to come back to why were there no studies done on humans of the biodistribution of the lipid nanoparticles with the active ingredient. They use a benign enzyme. They didn't actually use the spike protein.

Dr Skerritt : We will consult on what information we can provide from the dossiers. Remember, we have received over 200,000 pages of information on the Pfizer vaccine. Some of it is commercial-in-confidence, some is not. Again, there's a formal process where we can identify what information can be received. So I'm not going to categorically say there were no such studies done.

Senator RENNICK: I must say, now you've said there are hundreds of thousands of pages—

Dr Skerritt : About 220,000.

Senator RENNICK: In the freedom of information request you said no data was available whatsoever. You're contradicting yourself, No. 1. No. 2, I struggle with the concept that safety data should ever be commercial-in-confidence. We are looking at the lives—

Dr Skerritt : That's not a TGA decision. It's the law of the land when commercial-in-confidence information is submitted.

Senator RENNICK: Okay—

Dr Skerritt : Sorry, if I can finish my answer. I believe the FOI request was slightly different. We can go into the detail but, as you know, when departments or officials get an FOI request they obviously have to address the terms of the FOI request, and if it's not specific enough we go back to the requester and say, 'Can you be a bit more specific? What do you want?'

Se nator RENNICK: That freedom of information request was very specific. That was specific right down to the level of the biochemistry that was taking place. So I don't see how you could say that. But let's move on from that anyway. This is now the next question: the spike protein produced by the vaccine is not the same spike protein produced by the virus, is it? We've got two proline insertions. We've got three stop codons instead of one. We've got the use of pseudogenes and we've also got the use of a long chain of Genecia's, a nuclear-type of the mRNA—

Dr Skerritt : Poly-A sites are common at the end of messenger RNAs.

Senator RENNICK: I realise that. But you've added another 70. So there have been another 70 or so added. As you said the other day, that was to increase the stability of the spike protein.

Dr Skerritt : It increases the stability, but the additional stop codons also prevent any risk of translation beyond the length of the desired piece of mRNA—sorry, I'm getting a little bit biochemical here—that turns into the spike protein. So it's actually put in as an additional safety measure to create these additional stop codons.

Senator RENNICK: So there is no stop codon—

Dr Skerritt : There's no evidence the stop codons read through to that, and that's why there are two. In fact even in Australia the TGA labs do in vitro translation assays to confirm the identity of a product.

Senator RENNICK: So in vitro, as in a laboratory?

Dr Skerritt : In vitro is the only way that you can assess in a laboratory whether a piece of mRNA makes a piece of protein that you want it to do. Then you get the bit of protein and you make sure it's the right size and the right identity.

Senator RENNICK: You have measured that the created spike protein has got the same molecular weight as the virus?

Dr Skerritt : It will have a slightly different molecular weight because of the position of the stop codons and the use of pseudogenes, the additional uracil, which is one of the four bases of messenger RNA. So it is very similar and it is as expected and as provided. In the 220,000 pages of information we get on these vaccines, we get an awful lot of technical information on how they assess this product, what checks and balances they have put in to make sure that it is an appropriate spike protein that is translated, to use the technical word. And our laboratories then spend a lot of time with a team of people—we have 105 people roughly in our laboratories—replicating what Pfizer or AstraZeneca or any other company has given us. We don't just take their laboratory testing stuff as gospel. We actually have people with white lab coats who do this stuff to repeat and replicate their work.

Senator RENNICK: Thank you. What do the proline insertions do to the actual spike protein?

Dr Skerritt : We believe there's not a functional change as far as immunogenicity and as far as behaviour are concerned. Sometimes proline residue is used to stabilise what's known as the tertiary structure and sometimes even a quaternary structure, in other words, the three dimensional structure—now I do feel like I'm giving a biochemistry lecture—of the actual spike protein, because you want the body's immune system to recognise the spike protein that's been translated, converted from the messenger RNA into a protein. You want the body to recognise it in the same way that the body would recognise the virus protein if you were infected with the virus. That's one of the tricks of a good vaccine. It's got to look like the disease but it's not got to cause the disease.

Senator RENNICK: Then tell me this: what is the off switch for the production of the spike protein by mRNA?

Dr Skerritt : The off switch for translation—in other words, conversion—of the messenger RNA protein is actually the fact that there is a stop codon and, in this case, a couple of stop codons.

Senator RENNICK: But then you've now got a spike protein sitting within a cell, right? Does the cell express that spike protein or not?

Dr Skerritt : The translation of proteins occurs on ribosomes, not in the nucleus of the cell.

Senator RENNICK: I realise that. I know that.

Dr Skerritt : You had asserted earlier in other fora it was nuclear uptake. But our bodies translate proteins. As we're all sitting here we're probably translating tens of thousands of proteins at a time. So that happens in the cytoplasm on bodies known as ribosomes.

Senator RENNICK: I know that. Then the spike protein gets expressed out of the cell, does it not, because you've got to wait for the killer T cells?

Dr Skerritt : No, it's both B cells and T cells.

Senator RENNICK: The B cells are going to get the antibodies. The T cells are going to get the cells, right? So you've now got a toxic cell, right, that has—

Dr Skerritt : It's not a toxic cell, it's reacting to—

Senator RENNICK: It's producing a spike protein?

Dr Skerritt : Yes.

Senator RENNICK: But that's—

Dr Skerritt : But your B cells and T cells as you sit here are reacting against foreign proteins and other foreign substances.

Senator RENNICK: In the blood?

Dr Skerritt : Otherwise we'd all die within days to bacteria—

Senator RENNICK: Can you stop interrupting me and actually answer my question.

CHAIR: Final question.

Senator RENNICK: Sorry, Chair, but he's not actually answering my questions.

Senator Ruston: Chair, could I just make the point that I think Senator Rennick is suggesting that the official is interrupting him. I think he probably should look in the mirror. He is doing a fair bit of interrupting.

Senator RENNICK: Chair, he's not answering the question. That's the problem.

Senator Ruston: But he is answering the question. You may not like his answer but he is answering the question.

Senator RENNICK: No, he's not answering the question, which is: what then kills the cell that is producing the spike protein?

Dr Skerritt : Remember, it's the messenger RNA that's translated into protein which is a spike protein. Messenger RNAs are inherently unstable. In fact, that's why the Pfizer and Moderna vaccines require this little lipid coat, this little lipid nanoparticle.

Senator RENNICK: I understand that.

Dr Skerritt : Therefore, the messenger RNAs get digested by what are known as nucleases within the cells. They break down in a matter of minutes to hours inside the cell. Therefore it's done its work. It's made a little bit of spike protein. That then goes to the immune cells to create a response analogous to being infected. But the bottom line is messenger RNA is unstable. And so it does break down.

Senator RENNICK: I was given 48 hours as the half-life of mRNA.

Dr Skerritt : No, it depends very much on the messenger RNA. I'm happy to provide you with a review on half-life of mRNA. I don't believe it's 48 hours across the board.

Senator RENNICK: But in that 48 hours there's going to be an enormous amount of spike protein produced, isn't there?

Dr Skerritt : Not an enormous amount because, remember, the amounts of vaccine of messenger RNA are in the microgram level. So the idea is to introduce sufficient spike protein to activate the immune system so that it mimics a COVID infection so that your B cells and T cells can start to mount an immune response to protect the person from catching COVID.

Senator RENNICK: So before the immune system kicks in, how far will those spike proteins travel throughout the body?

Dr Skerritt : They will travel throughout the circulation, as will other foreign proteins, until they are trapped by the immune system.

Senator RENNICK: How much damage will they do before they are trapped by the immune system?

Dr Skerritt : No evidence of damage. You seem to be indicating that these are little arrows that are piercing holes in things. The protein by itself does not cause damage.

Senator RENNICK: I am going off the fact that 118,000 adverse events have been reported. There's a safety signal there; there's a massive red flag. A normal flu vaccine will report a couple of hundred adverse events a year off 11 or 12 million doses, and yet here we are with 118,000.

Dr Skerritt : No. We have talked before about the difference between an adverse event report and a known adverse event agreed in the product information. There is certainly an order of magnitude of fewer adverse events that are acknowledged in the product information. They are recognised to be adverse events following assessment of all those reports by global regulators. So there are not 118,000 known adverse events from messenger RNA vaccines.

CHAIR: Senator Roberts.

Senator ROBERTS: Thank you all for attending today. I would like to table a portion of the transcript from the previous session, on 16 February. There are 15 copies here. The latest available TGA DAEN report from your website dated 24 March, 2022 says that there are 801 deaths, 11 of which are attributed to COVID-19 vaccines—so there are 801 deaths reported by doctors. So according to the TGA, 801 deaths doctors have reported as being due to COVID-19 vaccination. Doctors reported them. The TGA then steps in and reviews these doctor-certified reports and says that there are only 11 deaths attributable to the COVID-19 vaccines. How many of the 790 cases have been reviewed and closed, and how many are still under review?

Dr Skerritt : Firstly, your assertion is not factually correct. Doctors have not said these 800-and-something deaths are due to COVID vaccination.

Senator ROBERTS: They have reported that.

Dr Skerritt : There have been reports. As we have said before in this place, doctors will often provide a report and then say in the report, 'We don't believe it's due to the vaccination'. In a majority of jurisdictions, a majority of states and territories, there is a requirement for the state and territory health systems and their doctors to report deaths that are temporarily associated—in other words, injection one day, someone has a heart attack a week later. But in many of those cases the doctors indicate that they don't believe there is a link. So I think it's highly misleading to say that the doctors say these deaths are due to a COVID vaccine. Having said that, as we have indicated, we review all deaths in these reports and we follow up for further information, including with coroners where coroners' reports are done for post-mortems, with the state and territory systems. These deaths are generally in health facilities, so there have been post-mortems and there is a thorough medical history on them. If there is something unusual and there is a possibility that it could be associated with a vaccine, we convene an independent—by 'independent', not departmental staff—expert group of relevant doctors to evaluate whether there is likely causality, and we use World Health Organization protocols. These approaches are used by regulators globally.

Senator ROBERTS: How many of the 790 cases have been reviewed and closed and how many are still under review?

Dr Skerritt : I would have to take that on notice at the current time. But the overwhelming majority have been. It's just that obviously it is a figure that changes by the hour.

Senator ROBERTS: That's fine; I am happy for you to take that on notice. Of any outstanding reported deaths, some could be deaths related to COVID-19 vaccination. Do you have a time frame for when the TGA adjudication will be completed?

Dr Skerritt : Our part is relatively fast once we have all the required information. But let's use a hypothetical of someone who has a vaccination on Tuesday and has a heart attack on Friday; they're in a hospital in Perth, and the WA health system reports it. This is a hypothetical. We obviously require the information from a post-mortem that may have been done: that person had, say, AstraZeneca and was it a major thrombosis or thrombocytopenia in their brain? It also requires post-mortems to be done. It may then require a coroner's report to be done. So the timing at which we can close a case and then, if we need to, refer it to this expert committee does depend on when we get the information from the hospital system, the post-mortem and all that. Otherwise you are working in the dark. So it is really important to have that objective information by the professional people who carry out post-mortems, and if need be, if it has been referred to the coroner, the advice from the coroner. Again, that is their professional role: to determine cause of death.

Senator ROBERTS: So it is variable. How long did the TGA reviews take per death?

Dr Skerritt : It is an iterative thing. If we have a death report we'll come back and say, 'It says "headache" in the report; can we get information on whether they had a bleed in the brain?' The hospital may respond within hours, or they may say, 'We've got the brain in the freezer'—this is a bit gory—and 'we'll have to look at the brain in a post-mortem sense'. Sometimes it can take weeks if they then have to do those laboratory and other forensic tests. Once we get the information, we move as quickly as possible. We also move as quickly as possible to report any reports of deaths. For example, the very first reported death, which was in April last year, I think we reported within 24 to 48 hours of the group concluding that it was associated. We do so in our weekly updates. Fortunately, there have been no confirmed deaths due to vaccination this year. There have also been no confirmed cases due to thrombosis or thrombocytopenia this year.

Senator ROBERTS: Australians, our constituents, want to know who is accountable for this process. Who decides whether the death was a COVID-19 vaccine death and who certifies that this is the case?

Dr Skerritt : If it is due to vaccination, it is the role of the Therapeutic Goods Administration as the safety regulator, but acting on the advice of this external panel, and with the commitment and responsibility of publishing weekly safety updates, which report this information.

Senator ROBERTS: You are the head of the TGA, so it is your responsibility?

Dr Skerritt : Yes.

Senator ROBERTS: So you're accountable?

Dr Skerritt : Yes.

Senator ROBERTS: Who is on the expert committee?

Dr Skerritt : There is no fixed expert committee. It's important to emphasise this: if, say, the death was due to some neurological condition, we have a large number of neurologists. It's not a standing committee, so there is no fixed membership. If it is a cardiac thing, we'll have cardiologists and we'll have cardiac pathologists. There are so many subspecialties in medicine these days. The composition of each panel is different because we want the best scientific and clinical expertise.

Senator ROBERTS: I've asked you, Professor Skerritt, about the questions raised at previous Senate estimates rounds. Referring to the transcript of 16 February, Senate estimates, down the bottom you will see that you have twice failed to deliver what you have promised. We asked first in October, and we had a six-week deadline for that.

Dr Skerritt : You asked for what in October?

Senator ROBERTS: The process by which deaths reported by doctors are reviewed by the TGA.

Dr Skerritt : We've provided to the government every response to every question on notice.

Senator ROBERTS: Then, Minister, who in the government is responsible? Professor Skerritt, I asked you again on 16 February, four months after the first request in October: 'Could we have that process in writing?' and you said: 'I believe it has been provided, but we can provide it again.' I said: 'We haven't received it' and you said: 'We can provide it to you.' They are categorical. It seems to me, Minister, that the head of the Therapeutic Goods Administration is saying he has provided it to the government. But the government hasn't provided it to us.

Dr Skerritt : I can't comment on the process following that. If you wish to write to me, please write to me and I can provide—

Senator ROBERTS: Professor Skerritt, we have asked you twice. Once we were put on notice and last February, just two months ago, you told us personally you would get it to us. This is the first I have heard about having to write to you about it.

Dr Skerritt : I don't deliver responses to you directly, Senator.

Senator ROBERTS: Then I ask the government: what has interceded? We have not got the material from the TGA.

CHAIR: Do we have a question on notice number that we are talking about?

Senator ROBERTS: Yes, we do.

CHAIR: That would be handy to have so that we can ask somebody to check that.

Senator ROBERTS: Question No.14: details of how a decision of death due to COVID vaccination is made.

CHAIR: What was the question on notice number? Do you know?

Senator ROBERTS: That was back in October; I don't know that one.

Senator Ruston: Senator, we'll take what you have just requested on notice and get you an answer because it seems to me that there is a bit of a misunderstanding here.

Senator ROBERTS: Twice.

Senator Ruston: Adjunct Professor Skerritt has indicated he will provide what you have requested. So we will endeavour during a break to be able to get to the bottom of that, and respond to you today.

CHAIR: I'm sure somebody who is listening to us at the moment will be able to follow that up for us.

Senator RENNICK: Minister, can you follow up my questions from October, too? I have lots of questions outstanding.

Senator Ruston: I will certainly have a look at that.

Senator ROBERTS: Yes, we have a huge number outstanding. Currently there are 61 of 136 questions on notice outstanding from the last Senate estimates; that is around 45 per cent of the questions we've asked. We have asked a lot of questions, but that is our right. We do it not only for ourselves but on behalf of our constituents. Forty-five per cent of the questions have not been answered.

Senator Ruston: If you could leave that with me, Senator, I'll respond to the committee as soon as I am able.

Senator ROBERTS: If vaccine-injured people are from identifiable subgroups, say due to specific health conditions, why did you not proactively allow medical exemptions for these groups; for example, those with comorbidities?

Dr Skerritt : Therapeutic Goods Administration is not involved in the provision of vaccine exemptions.

Senator ROBERTS: Well, who the hell is? We have had so many doctors and nurses tell us personally that it is almost impossible to get an exemption. I know of someone who got his first shot and then had a severe reaction to it and was required by his employer to have a second shot. We have heard this so many times.

Dr Murphy : The Chair of ATAGI will be here at 10 o'clock. ATAGI is responsible for determining the conditions where vaccines are contraindicated: a very small list of conditions. The Chair of ATAGI would be happy to answer that, I think, when he comes.

Senator ROBERTS: Thank you.

CHAIR: There is something General Frewen mentioned earlier in regard to the provision of vaccinations early on that I want to clarify: did Australia receive vaccinations at the earliest possible opportunity, or was there a delay?

Dr Murphy : I'll answer that. It is important to go back. The Scientific and Technical Advisory Group focused very much on the provision of locally produced vaccines. In every country in the world pretty much the earliest vaccines that were available were those produced locally. We focused very much on the University of Queensland vaccine and the AstraZeneca. We had the AstraZeneca vaccine available as soon as the regulatory process was completed. The Pfizer vaccine we bought as a backstop. We knew from Pfizer that we wouldn't be able to get it any earlier than they were able to provide it because they had all these sovereign restrictions, like in the US it was only being made available locally. Pfizer were only able to offer us that initial 10 million doses when we approached them in late 2020. We got those doses as soon as possible. Pfizer were not able to deliver us any earlier doses than they delivered. The AstraZeneca vaccine, which was our major vaccine, was available in large quantities as soon as the regulatory process was finished. There was no capacity to get any more Pfizer any earlier.

CHAIR: So there were no other options at that point?

Dr Murphy : There were no other options. Moderna wasn't available outside of the US until April or May of last year.

CHAIR: Is that a sovereign issue as well?

Dr Murphy : That was very much a sovereign issue. It was initially only manufactured in the US and President Trump required none of those vaccines to leave the US. That is why our strong focus on locally produced vaccines was paramount. AstraZeneca has been an incredibly successful vaccine: it did vaccinate the vast majority of our most vulnerable population and has saved thousands of lives. And we made it locally, here.

CHAIR: The one that's been announced recently in Victoria—what type of vaccine is that?

Dr Murphy : The Victorian plant is Moderna. Moderna will be setting up an mRNA vaccine plant. It's not just for COVID vaccines; they are doing work on influenza vaccines, mRNA influenza vaccines, and a range of other vaccines. It is basically bringing that mRNA vaccine technology to the Southern Hemisphere for the first time.

CHAIR: Will that be able to provide enough for Australia going forward?

Dr Murphy : Absolutely. We have already ordered more than enough COVID-19 vaccines for this year and next year, so we've got plentiful forward orders. In fact, we have distributed well over 25 million doses to our Pacific neighbours through DFAT. We've got plenty of vaccines for this year. In fact, General Frewen can tell you just how many vaccines are sitting in fridges waiting for those 40-year-olds to come and get their boosters. There's plenty of vaccines for this year and next year. From 2024, when the Moderna plant comes online, that will produce whatever we need for routine vaccines, any potential pandemic vaccines, any new variant vaccines and potentially some influenza vaccines as well.

CHAIR: Excellent. Thank you.

Senator ROBERTS: Chair, can I just ask something that I forgot to ask before I noted it rather than interrupt Professor Skerritt? You mentioned that, of the reports that you received from doctors about deaths, some explicitly say it's not due to the vaccine. Are you aware, and what are you doing about the fact that we have been told by a number of doctors that they are afraid to report vaccine deaths? Are you aware of that and what are you doing about it?

Dr Skerritt: I'm not aware of that and any doctor or individual, or even you on behalf of a constituent, with the relevant information can report a vaccine adverse event. It doesn't have to be a death; it can be a sore arm. Any individual can report directly to us.

Senat or ROBERTS: Do you do any auditing to make sure that process is being followed or that you're getting reasonably accurate numbers?

Dr Skerritt: As I've indicated, the reporting is two things: firstly, it's mandatory within a majority of the states but not all states; although, quite interestingly, the state that is the most active in reporting adverse events through the health system is Victoria. It's not one where in law it's written down; it's just seen as part of their medical practice. There is no force of law that says if Dr X out in the suburbs sees an adverse event that they must report it. Reporting of adverse events is not mandatory in Australia and it would require this place to change the Therapeutic Goods Act.

Prof. Kelly: Senator, I feel I need to say something here. There's been over 11 billion doses of vaccine given around the world: 11 billion doses. The risk-benefit profile of all of the vaccines that are in common use and the ones certainly that the TGA has regulated here in Australia is overwhelmingly in favour of benefit. There is no conspiracy here.

Senator ROBERTS: Can we have the numbers on that, please?

Prof. Kelly: Eleven billion doses have been used. We would have seen problems in 11 billion episodes of doses if they were there.

Senator ROBERTS: Why did you use the word 'conspiracy', because in my experience most of these kinds of derailments are due to incompetence or gutlessness in terms of not looking at the figures? I'm not accusing you of either of those. I'm just saying that's my experience. But you raised the word 'conspiracy'.

Prof. Kelly: I did raise the word 'conspiracy', Senator—

Senator ROBERTS: Are you aware that some doctors here and overseas have done the research and they say that as few as one per cent of adverse events are being reported? Some are saying as few as 10 per cent. So you multiply the deaths due to the vaccine, you multiply the adverse events due to the vaccines, on one estimate by a hundred, or on another estimate by 10.

Dr Skerritt: Senator, we don't believe that's a relevant comparison—

Senator ROBERTS: You don't believe it, but that's what doctors are telling me.

CHAIR : Senator Roberts, please let the witness respond.

Prof. Kelly: I'll pass to John in a moment but, just to be clear, I'm not accusing anyone of conspiracy here. But there are conspiracy theories around, and I think we have all heard them. They have particularly affected some of the more vulnerable parts of our population—and I'm referring here to Aboriginal and Torres Strait Islander communities—in a way that has caused harm. I feel it's my role as the Chief Medical Officer to look at that from the Australian perspective. I'll let Professor Skerritt answer about the issues you've raised in terms of reporting. We do know there is underreporting of a range of matters in many countries. In relation to the reasons that the statistics you and Senator Rennick have both mentioned about the number of reports the TGA has looked at—it is an extraordinary number—the vast majority, almost all of those, have been shown to have another explanation. And that is not hiding things; that is totally transparent. The TGA reports on this every week regularly. That's why I mentioned that word but, to be clear, I'm not saying that—

CHAIR: Senator Grogan.

Dr Skerritt: Just to explain, I agree that for some other medicines you might only have 10 or five per cent of adverse events reported. For the COVID vaccines, to use that cliched word, there's been an unprecedented communication approach to doctors, hospitals, health systems and the public about coming forward with adverse events. We want people to report adverse events. There's been a lot of awareness. For example, among the doctor networks we have a videoconference that was every two weeks—and there are other videoconferences that are held even more frequently—and it's now every four weeks. In fact, there's another one tomorrow. That has the heads of the AMA, the heads of the College of General Practitioners and many leading doctor and communication groups. Again, one of the consistent messages is 'report adverse events even if you don't think that there's a likelihood of them being associated'. I would say that for the COVID vaccines there's greater awareness than there ever has been for any other medical product.

The states and territories, as I've said, either have mandatory adverse event reporting for vaccines or they have pretty well organised systems, such as in Victoria. There's been a tremendous investment in what we call stimulated and active reporting. Through AusVaxSafety, a proportion of people who get vaccinated get SMSs at regular times and are contacted. So you're not requiring them to say, 'Gee, I don't feel well; it's an adverse event'. They're asked and followed up: 'Do you have any ill feelings, any adverse events? How are you going?' Taken together, I think we have probably the most comprehensive picture of safety of these products than we have had for any medical product ever on the market in Australia.

Senator ROBERTS: Professor Skerritt, I'd urge you to have a look at the systems for reporting, because I've had a number of reputable, credible doctors tell me that they are aware of adverse events not reported because AHPRA is intimidating doctors—

Dr Skerritt: Hold on—

Senator ROBERTS: And, Professor Kelly, if I could just mention that the word 'conspiracy' used to be used quite a bit in the past for exactly that, vague claims. But the word 'conspiracy' now is used as a defence to ridicule someone who's raising a genuine issue. That is quite often when I see the word 'conspiracy'. It's used to deflect. That's why I blew up about that.

Dr Skerritt: Frankly, AHPRA wouldn't know if a doctor reported an adverse event to us. The name of a reporting doctor is anonymous and confidential. They cannot take action; so how on earth could AHPRA sanction a doctor who reported an adverse event to the TGA? They wouldn't know.

Senator R OBERTS: Well, how can we get AHPRA here and ask them directly, because they're away from our scope? They were taken away from our scope, I understand, in 2017. They're giving edicts to doctors in this country and doctors are looking me in the face in massive groups—groups of 40 or more—in suburbs in Brisbane telling me that they've lost their doctor-patient relationship. They have to abide by health directives, and AHPRA is doing that.

Dr Skerritt: Senator, I simply do not believe that AHPRA has told doctors not to report adverse events.

Senator ROBERTS: Really?

Dr Skerritt: I'd believe a flat earth policy before that.

Senator ROBERTS: How do we get AHPRA here?

CHAIR: Senator Roberts has jumped in after I was about to hand to Senator Grogan before.

Senator ROBERTS: Chair, how do we get AHPRA here, because they're not accountable to the representative—

CHAIR: We have tried that before and that's a separate issue. We're not going to discuss that right now. We've taken that to the government before. Senator Ciccone.

Senator CICCONE: Thank you very much, Chair. I've got a couple of questions about our winter preparedness. Has there been any case of COVID with the new variant—I think it's XE—that's been detected here in Australia?

Prof. Kelly: Thank you for the question, Senator. We have a very strong process of monitoring the arrival of variants here in Australia. We get a weekly report from a group called 'Austracker'. It compiles all of the public health and other laboratory information in Australia. As part of that it also monitors the international situation. Before I specifically answer the question, I just want to point out that, similar to what Professor Skerritt has been talking about, we know much more about this virus than we know about any other virus in history. These small variations we've seen continue to be small variations of the original virus that was first found in China in late 2019. For example, the delta virus had 133 different slight variations before it has kind of disappeared now. We haven't seen a delta virus in that report since late December or early January.

We have three main strains of the omicron virus—three sort of branches, if you like—and from those branches various twigs come, and we will continue to see twigs. XA, XB, XC, XD, XE—these are just the way viruses change over time. We have a very good international and local way of monitoring these things. Clearly, the most important thing is: does it mean anything in terms of clinical presentation? Is it more transmissible? Is it more severe? The particular one you've mentioned has been found in some countries but, as far as I'm aware, it is not here yet. There is a lag of a few weeks so it possibly could be here, but there's no evidence of that associated with any change in the way we should be dealing with the virus.

Senator CICCONE: I appreciate your answer. Could you just clarify for me: which variants are currently in Australia at the moment? Are you also able to provide a breakdown of the proportion of infections as well that they make up?

Prof. Kelly: I tried to give a bit of background there. We don't know the whole genome sequencing of every single virus in Australia. At the moment there are hundreds of thousands of people who are active cases. We only have a small proportion of those that are having the whole genome sequencing, so I can't give a 100 per cent answer to that. But we are seeing thousands of whole genome sequencing done every week. Delta was the circulating virus until the end of last year or early this year. omicron, the original omicron—otherwise known as BA.1—as we know, came at the end of November and that dominated for a while. We have seen some BA.1.1, but not a lot. BA.2 is the one that's rapidly overtaken the BA.1 strain. In most jurisdictions in Australia now well over 80 per cent are BA.2. They are the ones that are mostly in hospital, ICU et cetera.

Senator CICCONE: You can take it on notice, but I'd appreciate any other information you can provide the committee in terms of those different variants in Australia.

Prof. Kelly: I'll take that on notice, Senator.

Senator CICCONE: I guess, as part of the health measures, the Commonwealth has extended the concessional rapid antigen tests until the end of July in partnership with the states. I understand the Commonwealth has also purchased, I think, six months worth of supply of PPE for aged care and for disability requirements. Is that right?

Dr Murphy : That's correct. We're pre-deploying PPE into every residential care facility, so they have a pre-deployment stock available should they need it.

Senator CICCONE: Have any aged-care and disability homes received this allocation of PPE yet?

D r Murphy : I'll get Mrs Norris to respond.

Mrs Norris : We have started to roll out the winter prep pre-deployments to aged-care facilities. As of 5 April, we have deployed 142 preventative packs across Western Australia, the Northern Territory, Tasmania and South Australia.

Senator CICCONE: How many was that again?

Mrs Norris : 142, and there'll be upcoming deliveries across April. We hope to finish the first rollout by mid-May.

Senator CICCONE: What will the PPE contain?

Mrs Norris : Packs are made up of five different sizes according to the size of the RACF, the facility. It contains gloves, gowns, face shields, goggles, waste bags and masks—N95s and surgicals.

Senator CICCONE: Will there be multiple replacements of this PPE to the facilities or is this just a one-off drop to the facility?

Mrs Norris : Facilities will have a one-off deployment at the beginning of the winter season. When they go into outbreak they'll be able to apply for additional packs throughout the season.

S enator CICCONE: How do they apply for that?

Mrs Norris : It's through our online portal that's being established at the moment. They'll be able to go in and advise what pack size they need.

Senator CICCONE: And that's how aged-care and disability facilities could request the PPE?

Mrs Norris : For aged-care facilities, not the disability sector at this stage.

Senator CICCONE: So how do aged-care and disability facilities request the PPE? Is it through that portal?

Mrs Norris : For aged care it is through the portal and for the disability sector it's through the Living with COVID Package and also through DSS, who have set up their own arrangements.

Senator CICCONE: If a facility is running low, is there a way for them to request more PPE from the department?

Mrs Norris : The PPE deliveries are for outbreak sites. If they go into outbreak, they're able to request additional PPE. If they've run out during that time and have used their first winter pack, they're able to request a smaller pack size to get them through the period before we can get them their larger pack.

Senator CICCONE: What's the threshold for an outbreak? Do you have to hit so many cases at the facility?

Mrs Norris : I would have to check with my aged-care colleagues. It's numbers of outbreaks within a particular facility, based on the size of the facility. I don't have that detail.

Senator CICCONE: It's what's the definition of an 'outbreak', I guess.

Mrs Norris : Yes. I'd have to ask my aged-care colleagues about that.

Senator CICCONE: Can you take it on notice?

Mrs Norris : Yes.

Senator CICCONE: Thank you.

Se nator GROGAN: Are you tracking the reinfection rates of COVID-19?

Prof. Kelly: It sounds like an easy question, but it's not. The main reason is that, with the increase in the volume of cases, those very detailed discussions that were happening—the famous contact-tracing exercises that were happening during 2020 and 2021 and, as I reported in my opening statement, they were very successful in protecting Australia—are no longer happening in most cases; some are. There would be some information, but it's not routinely reported from the states and territories to the Commonwealth. I would suggest that, in most cases, it is not actually requested. So I can't answer that question.

Senator GROGAN: In terms of the cases that are being reported, we are watching quite a lot of people around these parts—I've had two exposure notifications while we've been sitting here—dropping off the back of the last number of days of estimates. Say I was to catch COVID tomorrow, would I be required to report it to anyone?

Prof. Kelly: Yes. Depending on where you are, if you do a rapid antigen test, some jurisdictions, not all, require that is the law: you would actually report that to the local jurisdiction. Of course, if you had a PCR test, that would be automatically the case, even through a private laboratory or the state and territory situation.

Senator GROGAN: Potentially, we're in a situation where people would do a RAT test, it comes up positive and they go, 'I don't feel too bad; I'll just stay home, isolate and tell anyone I was hanging out with that they should go and get a test.' They then test negative, maybe they don't report it to the state, and we would not know that they had the virus. I suppose it's the same with the reinfection, because it's not a question that we would ask.

Prof. Kelly: That's correct. Going back to reinfection, we do know that, with the omicron wave, one of the reasons why it was so large, not only here but in most other countries in the rest of the world, was because there was an immune-escape element of that. Coming back to Senator Ciccone's question, there was an immune-escape component of that omicron—all of those that I mentioned—which allowed reinfection to happen. Going to your point about that, yes, there is no doubt that there are people in Australia now with COVID that we are not aware of. It ties also back to my original statement earlier that we're moving away from counting every case and focusing on that more vulnerable population, vulnerable to harm from the virus. The issue that my colleague Mrs Norris has just talked about, in terms of aged-care protection through winter, is part of that. The provision of treatments is part of that. The provision of rapid antigen tests in vulnerable settings like disability and aged care is part of that. We're really focusing on those people who are more likely to need treatments or where it's more likely to lead to severe infection rather than 'let's find every case' in the whole population. That is a change. It's a change that we've worked through deliberately and on the best medical advice that we have.

Senator GROGAN: With the reinfection cases, if you had a PCR to determine the first time you had it and then you had a PCR to determine the second time, there would be a data capture there, potentially?

Prof. Kelly: Yes, there would be, because all of those, at least at the state level, are recorded and would be able to be linked. We are continuing to work with the states and territories to allow a more national picture of that sort of thing to be done. There will be other colleagues here who could talk more about some of those projects that we're doing, linking, for example, vaccination status and residence; previous infection would be part of that, potentially.

Senator RENNICK: Professor Kelly, I noticed that you mentioned the words 'conspiracy theory' before. I want to bring your mind back to 2020, when, on 16 March, you mentioned that Australia might have 50,000 to 150,000 deaths; then Professor Brendan Murphy said, within a month, to a Senate COVID hearing, that the response had avoided 14,000 deaths; and then we've got a response from a professor from the University of Melbourne who predicted 25,000 to 55,000 deaths. If you're going to start casting aspersions about our questions, I don't think it's appropriate, given that the modelling has been very variable, to say the least, in regard to the COVID response. I'll jump off that. I wanted to make that as a comment.

I want to go back to the relative risk. I have the number of deaths here by decadal group. So far, since the outbreak of COVID, between the ages of 10 and 19, we've had two deaths out of 360,000 cases—this is up to 31 March and is off the Australian government website—and 16 deaths between 20 and 29. I'll stick to that 20-year period there. I know that the two teenagers had pre-existing comorbidities. How can you justify that the vaccine rollout is safe for younger children, when there's such a low rate of injury in those age groups for COVID but there's a much higher rate of vaccine injury?

I'll just put one other question to you because it ties in. What is an acceptable injury rate, noting the reported adverse events? This is to Professor Kelly, because I take it that Professor Skerritt reports to you, so you need to be monitoring his performance in terms of reviewing drugs. Professor Skerritt said on John Laws in August last year that there would be a serious rate of about one in a million. We're now at a higher rate, higher than one in 200, so that's out by a factor of 5,000. What's your acceptable rate of injury and how do you justify relative risk for younger people, where there's a much higher rate of vaccine injury compared to serious consequences from COVID?

Prof. Kelly: Thanks, Senator Rennick. Just to be very clear, we are always open to and, as Professor Skerritt has already mentioned, absolutely encourage reporting, and every report is taken seriously; so that is beyond doubt. Also, Professor Skerritt doesn't report to me; he reports to the secretary. We are colleagues.

Senator RENNICK: My apologies.

Prof. Kelly: I used to report to him. We're close colleagues and we talk a lot. I'll pass to him as the expert in this area and the one who is absolutely responsible for the safety monitoring.

Senator RENNICK: Let's go to Dr Murphy: (1) I want to know what you consider to be an acceptable rate of injury, and (2) how you can justify the relative risk for younger people where there's been such a low rate of serious consequence from COVID compared to adverse injuries from the vaccine. I've spoken to tens of mothers of teenagers who have had to take their children to hospital. How do you justify that: the relative risk and the acceptable rate of injury?

Dr Murphy : The risk-benefit is clearly in favour of vaccination. There may be very few deaths in young people, but there are other consequences of COVID. There's the—

Senator RENNICK: Can you quote some figures, instead of just saying—

Dr Murphy : Yes. Professor Skerritt has all of the figures.

Dr Skerritt: I think there's a bit of an exercise in 'Skerritt avoidance', Senator. We do have figures on risk and benefits. For example, multisystem inflammatory disease, which is not long COVID but a separate characteristic, affects about one in 3,000 children who are infected with COVID, and that can actually be debilitating for many months. There is, again, also long COVID. There's the impact on transmission to other family members and there is still the impact on families and social issues of children who are infected and, therefore, will be ill for a period. I don't think that it should be characterised in deaths. Actually, I was wrong; the rate was lower. I said back in August that the death rate from these vaccines appears to be about one in a million.

Senator RENNICK: No, the injury rate. You said the severe—

Dr Skerritt: No, I did not say that; no, I did not. I said last year that the death rate was about one in a million.

Senator RENNICK: You didn't. I'm going to come back to you on that.

Dr Skerritt: Okay, please do, because I will go back to my publicly available weekly adverse event reports, which do show, obviously, a rate of adverse events greater than one in a million. I think it would be crazy for anyone to say that an adverse event is one in a million; I said a death rate. Actually, I was wrong because we are now—General Frewen, I think, can correct my figure—at about 54 million doses.

Lt Gen. Frewen : We are at 56.6 million doses.

Dr Skerritt: Okay. I'm always a week or two out of date. Out of 56 million doses, we have 11 deaths. That's actually one in five million, so I was wrong; it has ended up being far less than one in a million.

Dr Murphy : Senator Rennick, if you want, the Chair of ATAGI, Professor Crawford, who is a paediatrician, is here, and he lives his day with children and the risk-benefit of vaccination. If you wish to pursue this issue further, we can bring him to the table.

Senator RENNICK: Hang on; let's just finish this off. I've got the quote here. It is:

As you know, there's a very rare chance of side effects with both vaccines but these are a few in a million.

That is from the health government website.

Dr Skerritt: Okay. We will look at the context of that statement and the time at which it was made. But, clearly, as a senior official, I would—

Senator RENNICK: So it's much higher—

Dr Skerritt: Clearly, as a senior official, I wouldn't have made a statement that contradicts a report that I clear every week. I clear the weekly vaccine safety report, so I wouldn't have made a statement that conflicts with it.

Senator RENNICK: You did; it's right here on the website.

Dr Skerritt: Senator, we need to see the context of that. I think that is only fair and reasonable.

Senator RENNICK: Yes, okay. I'll read it to you. It says, 'So for 99.99999 per cent of the people'—that's one in a million—'these are very safe vaccines'. You said that. It's on the record. It's on health.gov.au. You can Google 'Professor Skerritt and John Laws' and it will come up. As for the multisystem inflammatory syndrome, you're saying one in 3,000. If we go back and look at the numbers here, 360,000 teenagers divided by 3,000 is 120. That's 120 children who would get multi-inflammatory disease. We have many more than 120 teenagers who have reported serious adverse events from the vaccines.

Dr Skerritt: Again, I think we need to look at the actual numbers of cases. If you look at, say, myocarditis cases from vaccines, as of 27 March, across all ages, we have a total of 589.

Senator RENNICK: That's more than—

Dr Skerritt: Hold on; I said all ages, not teenagers. The number for teenagers is somewhat lower. I'd also add that, if I had to choose between MISC and myocarditis as a teenager, I'd choose myocarditis any day because the overwhelming majority of those myocarditis cases are resolvable in a few days, and we are doing long-term follow-up; whereas, if you go to the clinical literature on MISC, it's something that is debilitating for months.

Senator RENNICK: I'm glad you raise that because I'll raise Faith Ranson. She's a 16-year-old girl from Tasmania who's been debilitated for months as well. She's finding it difficult to get a proper diagnosis. She's been gaslighted. So it's not just myocarditis that these teenagers are suffering from; they're suffering from functional neurological disorders or neurological disorders and having other issues as well. So you can't just narrow it down to one adverse event and imply that's the only side effect.

Dr Skerritt: Senator, as you know, we do not talk about individual cases, especially of minors but not even of adults. There are neurological adverse events that have been attributed to the AstraZeneca vaccine; however, diffuse neurological adverse events are not a recognised side effect of the Pfizer vaccine.

Senator RENNICK: From a trial? Actually, I'll dispute that as well because it's in the post-marketing—

Dr Skerritt: No, post-marketing, not a trial.

Senator RENNICK: No; that was from real life. So you're happy to take it from real life when it suits you but not now.

Dr Skerritt: No, we're happy to take studies that are assessed through doctors, through the state health systems, in conjunction with experts in the field, and that also have been assessed globally by other regulators and in the refereed international medical literature; in other words—

Sena tor RENNICK: Excuse me; that contradicts what ATAGI told me last year, when you approved the vaccine for children between five and 11, and you were more than happy to take the anecdotal stories or passive surveillance of the five million to six million children who took the Pfizer vaccine in the States. So what is it?

Dr Skerritt: But that's not a contradiction—

Senator RENNICK: Sometimes you say that you want a clinical study and at other times you don't.

Dr Skerritt: That's not a contradiction whatsoever. A very important part of post-market monitoring for a medicine or a vaccine is what is known as passive reports. These are people who, through their health systems or as individuals, report adverse events. Those adverse events, like in Australia, have been analysed. Again we've used the phrase 'one in a million' a lot. The latest data from the US Centres for Disease Control and Prevention on serious adverse events in children is down to about the one-in-a-million level. The rate of adverse events in children has proven to be actually lower than in adults.

Prof. Kelly: We have an actual paediatrician online who, every day, actually sees actual children with COVID. I really think we should hear from Professor Crawford.

Senator R ENNICK: I talk to people about adverse events every day from five in the morning until 11 at night.

CHAIR: Senator Rennick, I think we might ask Professor Crawford whether he would like to contribute.

Prof. Crawford : I think it's important to have this discussion around the risk-benefit. Certainly from the paediatric side, ATAGI continues to meet weekly and does get updates from the TGA, from John Skerritt's colleagues, in terms of the adverse events that we're seeing in the post-marketing surveillance. I think it is important to sort of divide our program into the different age groups. For the five-to-11 age group, at the start of our program in January we did recommend the interval of eight weeks in monitoring very closely for any myocarditis and pericarditis cases in that age group. There have been very few to date, acknowledging that we are now rolling out those second doses. So we're monitoring closely but we haven't seen a high level of reporting of heart issues in that age group. In terms of the adolescent age group, I agree that it's again important to think about the risk-benefit, in terms of both severe COVID that ends up in hospital and also the multisystem inflammatory syndrome which peaks actually around nine years of age and goes down to four or five, as well as something called Kawasaki disease which is in the same spectrum, as well as into the teenage years. Definitely having vaccination protects you from both those conditions.

There are quite a few adolescents in the ICU. I'm a paediatrician now talking as a clinician at the Royal Children's Hospital in Melbourne. We did see a number of adolescents admitted to our intensive care unit with significant severe COVID with the delta wave. We know that, by having vaccination, the risk of being hospitalised is dramatically reduced. We do acknowledge that there are very few deaths in this age group with COVID but that doesn't mean that there's not morbidity in terms of coming into hospital. It's the same with the younger age groups. We are seeing some croup now with COVID, some of which does need intensive care management and therapy. So this is not an insignificant illness in a number of children, as well as obviously having some being hospitalised with milder symptoms, as well as having it circulating in the community. I think it is really important to keep considering the number of cases that are presenting with regard to a more severe disease, and that will vary by the different age groups.

Going to the topic of adverse events, we are also involved in monitoring adverse events in those age groups. Indeed, I agree that we need to monitor and take that seriously and have those updates from the TGA, and any changes in the program or recommendations will come on the basis of that evidence which is also being followed up closely with our international colleagues. So there's lots of reporting coming out of both the United States and Israel, who obviously are a little bit ahead of us in terms of the number of doses and age groups that they've administered to. We're very supportive of the ongoing program with that risk-benefit analysis. I'll pause there.

CHAIR: Are there any further questions, Senator Rennick, for Professor Crawford?

Senator RENNICK: Not really. You've given a good description there and I appreciate that, but I didn't get hard numbers. I've got one in 3,000, which equates to about 120 teenagers, and probably about, say, 90 children, if they get it. But again I say that number is less than the number of serious adverse events reported. We know that because, in the freedom of information that came out on 17 December last year, I think there were about, off the top of my head, 300 or 400 serious adverse events in teenagers.

CHAIR: I'm just going to see whether Senator Antic has a question or two.

Senator ANTIC: I've got a few questions. This one is probably to Professor Skerritt. Recently the US Supreme Court, I think, forced Pfizer to release documents regarding adverse events from 1 December 2020 through to 28 February 2021. A whole lot of data came out of that. But one that struck me was that there were 274 adverse events relating to pregnancy, including 23 spontaneous abortions. Why is it that the TGA still recommends pregnant women get vaccinated, even though these vaccines are responsible for the deaths of 23—

Dr Skerritt: Senator, I—

Senator ANTIC: I haven't finished—unborn children? Thank you.

Dr Skerritt: I disagree with your assumption.

Senator ANTIC: You disagree with that fact?

Dr Skerritt: It is not a fact. You are misinterpreting causality here. There are several studies, and I'm happy to provide them on notice. In fact, there was even a study published overnight which looked at the first trimester in detail and foetal imaging. That has shown that there is no impact of these vaccines on pregnancy outcomes, either miscarriages or foetal development; so no—

Senator ANTIC: You are disputing that data?

Dr Skerritt: I'm sorry?

Senator ANTIC: You're disputing Pfizer's data on that?

Dr Skerritt: You are misinterpreting Pfizer's data.

Senator ANTIC: You're disputing what I'm saying?

Dr Skerritt: I am disputing your interpretation because it is wrong.

Senator ANTIC: So what is the statistic for pregnant women?

Dr Skerritt: It depends on the range and the stage of pregnancies—and there are various figures, anywhere between 10 and 15 per cent, even up to 20 per cent in some studies—which, from conception, do not go through to completion in perfectly healthy women. So we know that—

Senator ANTIC: They were natural events, were they?

Dr Skerritt: Yes. So we know that—

Senator ANTIC: Thank you. That's fine.

Dr Skerritt: Sorry, can I have one or two more sentences? We know that, sadly, women lose babies, especially early in the piece and sometimes, very sadly, late in the piece. There is no difference in the rate of miscarriage, spontaneous abortion and foetal abnormalities between those vaccinated and those unvaccinated. I'm happy to provide, on notice, at least six or seven studies.

Senator ANTIC: Does the TGA—

Prof. Kelly: Perhaps I could just add to that. It's very clear, as we've been talking throughout, that the benefit of vaccination in that exact same group people who have caught COVID and have led to all of the outcomes—

Senator ANTIC: What's the benefit, the myocarditis or the pericarditis? What's the benefit?

Prof. Kelly: No. We're talking about pregnancy, we're talking about stillbirth, we're talking about premature birth and we're talking about pregnant women ending up—

Senator ANTIC: Should pregnant women be forced to take a vaccine when they don't want to?

CHAIR: Senator Antic, please don't speak over the witness.

Prof. Kelly: We're seeing pregnant women being admitted to intensive care and even, in some circumstances, the death of pregnant women. So it's talking about the benefit and the risk. That is the way we always look at all therapeutic goods but particularly vaccinations. As I said before, there are no vaccinations in the history of this process that have been as well documented or as examined in that regard throughout the world—

Senator ANTIC: That's not quite true, is it?

Prof. Kelly: It is now, with 11 billion, now almost 12 billion, doses being put through. With respect, we always absolutely want to hear about the risks but we need to balance that with the benefits. That's what ATAGI does on a daily basis. Every week I work with them and talk to Professor Crawford about that matter.

Senator ANTIC: We've got to get through this because we're running out of time. Given that this data has now been made available and more tranches of documents are being released, does the TGA reject all that Pfizer data?

Dr Skerritt: No. We accept it and we acknowledge it. We actually have that data. Again that data is of reports. If a woman gets vaccinated on Tuesday and, sadly, has a miscarriage the following Wednesday, it is reported in that dataset. But the same woman could have had a cappuccino. So the main issue is—

Senator ANTIC: So it's coffee that is giving people myocarditis?

Dr Skerritt: The main issue is to see whether there is a difference in the rates, and there is not, and to see whether there is any causality by our very sophisticated—

Senator ANTIC: Has this data caused the TGA to amend its advice in any way about taking the Pfizer vaccines?

Dr Skerritt: No, it has not, because these are facts that we had already.

Senator ANTIC: Thank you. I've got a different line of questions, and these might be for the department more broadly. As it stands right now, I understand that, if you're an Australian citizen or a permanent resident, you can't leave Australia unless you're fully vaccinated and yet foreign citizens are able to leave at any time. What is the rationale behind this? What is the science behind this? Is this not more the sort of thing that we'd see in communist North Korea—stopping citizens leaving our country?

Prof. Kelly: I think Senator Rennick asked me the same question last week and I gave the answer: there has been a change in the biosecurity arrangements. It is now, under the Biosecurity Act, a requirement of anyone leaving Australia, regardless of their visa status, to provide evidence of vaccination, if asked by an official.

Senator ANTIC: Why?

Prof. Kelly: That is under the biosecurity legislation. It was a decision of government.

Senator ANTIC: I'm asking you why that is a requirement. Somebody can answer that question surely.

Prof. Kelly: Yes. I provided advice to the minister to make that decision.

Senator ANTIC: What was that advice?

Prof. Kelly: The advice, in relation to people exiting Australia, was in relation to our obligations under the International Health Regulations for protecting other countries. We have—

Senator ANTIC: Just on that, what is the science behind that decision, given that we know—I think we would all accept this—that transmission is irrelevant? When vaccinated you are effectively as infectious as you were if you were not vaccinated.

Prof. Kelly: That's not a true statement.

Senator ANTIC: That is a true statement. That's agreed to by almost all experts.

Prof. Kelly: It's not a true statement.

Senator ANTIC: What degree of benefit are you given by vaccination, in terms of dampening down your transmission, for want of a better way of putting it?

Prof. Kelly: There is evidence about that and I can provide it on notice.

Senator ANTIC: But how much? Is it one per cent, is it two per cent?

Prof. Kelly: I'll provide that on notice.

Senator ANTIC: No; you can tell me right now.

CHAIR: Senator Antic, the witness has agreed to provide it on notice.

Senator ANTIC: How can we not know the answer to that right now?

CHAIR: Please do not harass the witnesses.

Senator ANTIC: Australian citizens are being stopped from going overseas for this. It should be a fairly simple question.

Prof. Kelly: I'll provide that information on notice.

Senator ANTIC: I'm going to finish up then—because this hasn't been very helpful—with a very simple question for the department. It is one which has troubled me for a great deal of time with the bureaucracy here. Can someone please provide me with a definition of what a woman is? Department of Health, can you give me the definition of a man and the definition of a woman—anyone? It's basic stuff. Professor Murphy?

Dr Murphy : I think there are a variety of definitions and I think—

Senator ANTIC: Just a simple one.

Dr Mur phy : Perhaps to give a more fulsome answer, we should take that on notice.

Senator ANTIC: You're going to take on notice the question of what a woman is.

Dr Murphy : It's a very contested space at the moment. There are obviously biological definitions—

Senator ANTIC: It's not just 'a woman who is born a woman'—

Dr Murphy : but there are definitions in terms of how people identify themselves. We're happy to provide our working definitions on those.

Senator ANTIC: I've only been here for two years and that's the best thing I've seen thus far. Thank you so much.

Senator Ruston: Senator, I'm sure that they can get you a definition—

Senator ANTIC: A definition of a woman? Thank you, Minister.

Senator Ruston: I'm sure that they can and I'm sure that we will.

Senator ANTIC: I look forward to it.

Senator RENNICK: Chair, perhaps I can correct the record regarding the number of serious adverse events. This was reported by the TGA on 17 December, freedom information 35-20. It says that the number of serious adverse events—this is 'serious' and not all adverse events; it's what the TGA class as serious—for persons under 18 was 346. That includes people between 12 and 18 because, until 17 December, children under 12 weren't getting the vaccine. If we go back to our 360,000 people at 31 March and take one in 3,000, that's 120 with multi-inflammatory disease. Then if we times that by 60 per cent, that's 72. So we're—

Dr Skerritt: Senator, can I suggest—

Senator RENNI CK: Hang on; I haven't finished yet. So we're looking at about 70 people in that age group with multi-inflammatory disease, those 346 serious, but not all, adverse events reported in teenagers.

Dr Skerritt: You're comparing apples with oranges—

Senator RENNICK: I'm not. I'm talking about relative risk here. This is data from your own agency.

Dr Skerritt: I suggest that we provide you with the number of serious adverse events for those under 12. Given the rollout, as you've agreed, has started for that group, and that's the group that you've expressed greatest concern with, we'll provide you with that figure as well.

Senator RENNICK: You can. But I want to talk about what we've got in front of us now. I don't want you deflecting.

Dr Skerritt: No, no.

Senator RENNICK: What we've got in front of us now is 346 serious adverse events in teenagers as at 17 December.

Dr Skerritt: As I said earlier, that includes things like myocarditis, where someone may be affected by it by—

Senator REN NICK: For life. So this defines someone with life-debilitating—

Dr Skerritt: Wrong, myocarditis is not a lifelong affliction—

Senator RENNICK: No. This is under 'serious'. This is under 'serious adverse events'.

Dr Skerritt: Yes. Myocarditis, even if it affects a kid for 36 hours, is included as a serious adverse event. As has been indicated by Professor Crawford, who deals with children, including in intensive care, every day, the multisystem inflammatory disorder lasts for months.

CHAIR: Senator Rennick, please let the witness finish his answer.

Senator RENNICK: I've got 346 here from the vaccine versus 120 for multisystem inflammatory disease. The numbers speak for themselves.

Dr Skerritt: No, they don't, because on any day a 48-hour adverse event would be less—

Senator RENNICK: Less chance?

Dr Skerritt: Sorry, would have less medical impact than something that lasts for many months.

Senator RENNICK: The definition of a serious adverse event is that it's ongoing. If it were only 48 hours, it wouldn't be classed as that.

Dr Skerritt: No, no—

Senator RENNICK: That's your own definition. I've read—

Dr Skerritt: We record things like myocarditis as a serious adverse event, even though the experience is, in the overwhelming majority of the cases, that it is lasting a few days in these individuals.

Senator RENNICK: You're misleading here. It is not. A serious adverse event is ongoing. That's why it's classified serious. I'll leave it at that because—

Dr Skerritt: Again, in that 346, we included those myocarditis cases which range in severity but are confirmed as myocarditis for a short period of time.

Senator RENNICK: Any form of myocarditis is severe; don't downplay it.

Dr Skerritt: You've just contradicted yourself because you've said at one stage that myocarditis shouldn't be included as a severe adverse event unless it lasts for some months or is ongoing.

Senator RENNICK: It shouldn't be included as—

Dr Skerritt: And then you've said that it is severe. But I'm happy to give you those figures for the under-12s.

Senator GROGAN: Have any additional winter vaccine booster doses been administered yet, the fourth lot?

Lt Gen. Frewen : We commenced on the 4th, just a few days ago. There are two elements to this. A number of fourth doses have been administered to the immunocompromised, where their initial course was three doses, as opposed to two. So when they had their booster they have had four doses. When we started the program more than 100,000 doses had already been administered. Two days ago we administered 6,600 winter doses and yesterday we administered 7,700 winter doses. The total number of people in the over-65 category who have had a winter dose now is just over 60,000, and the number of Indigenous 50-plus people is 1,696. They are the details we have so far.

Senator GROGAN: On Friday we discussed the in-reach, the EOI, that you've done for aged-care facilities. How many aged-care facilities have taken up that offer so far, bearing in mind that some of them won't take up that offer because they have their own separate arrangements?

Lt Gen. Frewen : I might pass to Ms Blewitt for the detail on this.

Ms Blewitt : We have had 139 expressions of interest at this stage.

Senator GROGAN: Out of how many facilities?

Ms Blewitt : A bit over 2,500 facilities.

Senator GROGAN: You did give me the other number the other day.

Ms Blewitt : Yes.

Senator GROGAN: When do you think you'll start entering those facilities?

Ms Blewitt : Normally, the process is that we allocate them to what we call a VAPP, a vaccine administration service provider, and we've done that mapping already. Once we have done that, the vaccine administrator will contact the service and make arrangements with them. The facility itself has to get consent and organise administrative things and logistics. We are starting to schedule what that would look like.

Senator GROGAN: Do you have a sense of when that might be, bearing in mind that there are those processes?

Ms Blewitt : Starting?

Senator GROGAN: Yes.

Ms Blewitt : I do not know whether there are any scheduled this week. Let me check.

Dr Hart : Of those 139, 76 are for when the residents will be eligible during April for their winter dose. So they will be prioritised. We don't have the actual schedule yet because we are still working through with the vaccine providers. As Ms Blewitt said, they will work with the facility to make sure that it is convenient and works for them, but those 76 will be the ones we prioritise and for which in-reach will be provided in the first instance.

Ms Blew itt : As James said, 76 out of the 139 are eligible in April. Of those 139, 46 would be eligible in May, and 17 in June. That is just from those expressions of interest.

Senator GROGAN: When will you have people on the ground in those 76 priority facilities?

Dr Hart : We don't have the exact schedule lined up yet but, as Ms Blewitt has said, it is an arrangement to be sorted out between the vaccine provider and what is convenient with the aged-care facility. There's no capacity issue from our perspective. We have plenty of vaccine providers, so we can make that happen as soon as the arrangements, such as consent and all those sorts of issues, are worked through. So I imagine that in the coming weeks we would see on-the-ground vaccinations occurring in those facilities.

Senator GROGAN: Have those vaccine providers been contracted?

Ms Blewitt : Yes.

Senator GROGAN: Can you provide us with a list of who is providing those services?

Ms Blewitt : Yes. It's available on the Health website, but I can send it to you. You may recall—I might have mentioned it on Friday; I'm just trying to remember my evidence—that we went out and did a whole-of-government panel arrangement, and 82 providers have been found suitable across that program.

Senator GROGAN: And that is published on your website?

Ms Blewitt : Published on the website.

Senator GROGAN: We did speak on Friday again about the fact that a number of the facilities have an arrangement in place with a local provider anyway, so they probably won't be responding to your EOI. They'll probably be organising their own scenario with their existing structures. Do you have a way of tracking that? If a provider is going to fall through the cracks, do you have a way of identifying that?

Ms Blewitt : The process we have set up is that we've got the PHNs involved and encouraged the RACFs, the residential aged-care facilities, to make arrangements with the PHN. Those PHNs can also facilitate the primary-care provider arrangement, so we are relying on that. In addition, we're making some changes to the My Aged Care portal, which you would probably be familiar with, where we will require mandatory reporting from the facilities of who have been vaccinated.

Senator GROGAN: Did you say 'mandatory reporting'?

Ms Blewitt : Yes. We have done that previously on the first and second doses and the booster arrangement, and we'll introduce the same arrangement with the winter, so we can then track that. Similarly to what we're doing with the booster dose arrangement now, where we've had facilities and we've tracked with the My Aged Care portal, where there has been considered a lower number of vaccinations, it allows us to actively contact those facilities and offer them a second round of in-reach. The booster dose at the moment is often for workers as well as residential facilities. We've had about 750 of those RACFs and we've done a second in-reach under the booster program because we've tracked where they are, in terms of the number of people who have actually had vaccinations. So we'll do a similar arrangement for the winter dose.

Senator GROGAN: Do you have an expected completion date for this round of boosters? Now that you've referenced the people who you know are eligible in April, May and June, how far out do you think this will roll?

Ms Blewitt : In the residential aged-care facilities—Dr Hart can probably share with you the eligibility—I suspect at the end of June. So the residential aged-care facilities will be rolling out in about April, May and June; I expect that to be done then.

Dr Hart : As Ms Blewitt has said, there's no defined end date, as such. As Ms Blewitt was saying, in terms of the booster rollout, we've continued to go back and do follow-up visits, and through that close to 12,000 extra residents have been vaccinated with their booster as well. As the requests come in, we'll prioritise them and continue to roll out. We'll do follow-up visits as well, especially when we get the mandatory reporting in place, and we'll have a clear picture of whether there are any gaps and make sure we close those gaps as well. As you pointed out rightly, in terms of primary care, that's available at any stage and at any point as well too. That will continue to roll on as a combined effort.

Senat or GROGAN: As you're tracking the second booster, will you also be tracking at the same time who is and who isn't getting the flu shot?

Ms Blewitt : The flu is not part of the vaccine rollout.

Senator GROGAN: No, but strong advice has been issued for some time to get that.

Dr Murphy : There's a legal requirement now for them to be recorded in the immunisation register, so we'll be able to get a very accurate reporting of the flu vaccination uptake for every citizen. It is now legally required for all vaccine requirements to enter flu vaccination in the immunisation register, so that will be something we can follow.

Senator GROGAN: Will the data around the boosters be added to the vaccination summary reporting?

Ms Blewitt : Yes. I mentioned on Friday that we're looking at doing that.

Senator GROGAN: I have a question about the government commitment last year to 15 million doses of the vaccine being provided to the Pacific and Timor Leste; I think that was a commitment. Those 15 million doses were to be provided by the middle of 2022. How many of those have been delivered so far?

Lt Gen. Frewen : There has been a commitment for 60 million doses to be delivered.

Senator GROGAN: There was a press release.

Lt Gen. Frewen : Yes. There is up to 60 million doses by the end of 2022 and 20 million of those are underway. There will be another 20 million later this year. An additional 20 million are being financed through a partnership with UNICEF. So, it's 60 million doses overall by the end of this year. Presently, we have provided around 25 million doses, 16 million of which have been a direct donation through DFAT to countries; the other is through that UNICEF arrangement. All of this is ongoing. In terms of the Pacific—these are indicative; there is a list of countries—we have done over a million doses to Fiji, over 350,000 doses to the Solomon Islands and over 777,000 doses to Timor Leste. Into the broader region—this is an indicative list—we've done over eight million doses to Indonesia, 700,000 doses to the Philippines and over 4.2 million doses to Vietnam, as examples.

Ms Blewitt : The general has read out our domestic contribution, which is at 16.3. On the DFAT site, you will find—it's public information—a figure of 25.267. That will give you some slightly higher numbers because that takes in the additional 20 million doses through the arrangement with DFAT and UNICEF. For the example in Timor Leste it is more than a million doses, taking into account the contribution we have made from our domestic supply as well as the additional from DFAT. That is public information on the DFAT site.

Senator GROGAN: So those 15 million that were specifically targeted, as announced by the minister back in July 2021, were 15 million to our closest partners in the Pacific and Timor Leste by mid-2022. There's a sense that, while some of those contributions are going well, some of them are going quite slowly. So it was that very specific one I was after.

Dr Hart : Yes. In the domestic direct donations through DFAT into the Pacific and our near region, 16.2 million doses have already been delivered.

Senator GROGAN: Thank you.

Proceedings suspended from 10:58 to 11:18

CHAIR: We will now resume and continue on with outcome 1, programs 1.8 and 1.9, Therapeutic Goods Association and the Office of Gene Technology Regulator, noting that ATAGI is also online, if there are any questions. We'll go to Senator Roberts.

Senator ROBERTS: My questions are for TGA. Did your office obtain de-identified clinical patient data from the COVID-19 vaccine trials; and did that data form your decision on the vaccine, or did you just accept what the manufacturer said?

Dr Skerritt : The long-established process is that we receive an aggregate submission, looking at the analyses of patient data. Then, during the review, our clinicians review that data carefully. Also, there is our advisory committee for medicines, which is composed of eminent clinicians across various disciplines, and we go back and ask a series of questions of the company. Of the global regulators, only the US Food and Drug Administration obtains individual patient data as a course of practice.

Senator ROBERTS: So the answer is 'no'.

Dr Skerritt : We do not obtain individual patient data. We're simply not resourced to do so.

Senator ROBERTS: That's fine. I just needed the answer. The TGA, with all of its resources, didn't take the opportunity to review approximately 44,000 records from the vaccine testing, yet you approved it to inject into millions of Australians.

Dr Skerritt : I don't agree that we didn't take the opportunity to review the results of the trials. We spent many person months—in fact, probably several person years, if you aggregate the size of the team of clinicians and others—looking at that data. We looked at that data of the 44,000 people in the trials very carefully.

Senator ROBERTS: What clinical testing was done in Australia on the COVID-19 vaccines?

Dr Skerritt : There were some vaccines that have had early stage trials done in Australia, but it is not a requirement that medicine or vaccines are clinically trialled in Australia. If it were a requirement, we'd have far fewer medicines and vaccines on the market. We look for trials done in comparable populations. We assume a trial done on an American is going to be transferable to the Australian population. However, if there are trial groups missing—for example, we have a lot of Australians of Asian descent—we'll look at that in the trial data too.

Senator ROBERTS: So you also assume then that a trial by an American pharmaceutical company done on Americans is just acceptable.

Dr Skerritt : We don't assume that it's just acceptable. As I've mentioned, the total amount of data for Pfizer is over 220,000 pages. That would fill many pallets of paper if it were deposited in the middle of this room. We scrutinise and review that data at extreme lengths. We spend thousands of man and woman hours reviewing that data.

Senator ROBERTS: But no testing here.

Dr Skerritt : We test the vaccine here in our laboratories. As I mentioned earlier, we have about 105 laboratory staff.

Senator ROBERTS: Are those tests to make sure that the controlled batches comply with the current batches in this country? Are they actually testing the vaccine for its efficacy and for its safety?

Dr Skerritt : The tests relate to safety because they check the vaccine's composition—they check that there are no contaminants in it—and they check that it is in line with the requirements of the vaccine.

Senator ROBERTS: So you're not testing the vaccine's efficacy, safety or risk.

Dr Skerritt : We are looking at safety in a post-market sense. The data for efficacy and safety comes from clinical trials that are being conducted globally. I would add that the same approach is accepted by all the world's major regulators, including Europe. The European Medicines Agency, which regulates for the European Union, does not require trials to be done within Europe.

Senator ROBERTS: Are you aware that there are major concerns about the FDA processes in America and many of the health agencies in America being completely tainted by pharmaceutical companies—

Dr Skerr itt : TGA makes independent sovereign evaluations of vaccines. This government expressly rejected a possibility of TGA automatically accepting US FDA decisions. The government position—it was accepted in this place, when a bill went through the House—was for TGA to continue to make its own sovereign decisions, and we don't always make the same decisions as FDA around medicines and drugs.

Senator ROBERTS: And you rely upon various committees—

Dr Skerritt : Yes, we do.

Senator ROBERTS: for approval of different types of drugs, including vaccines?

Dr Skerritt : We rely on them for advice. We have an active advisory committee for vaccines and an advisory committee for medicines, for example, that look at the treatments.

Senator ROBERTS: Have you assessed that committee's composition for conflicts of interest?

Dr Skerritt : Very much so.

Senator ROBERTS: Can we get a copy of that?

Dr Skerritt : There would be individual personal information. I don't think it's appropriate to say, 'Dr So-and-so was X,' but we could explain the process and we could explain those candidates who were not considered.

Senator ROBERTS: Yes, please.

Dr Skerritt : So, within those constraints, of course, you would be very welcome to it, because it is absolutely important that the people on the committees do not have a conflict of interest.

Senator ROBERTS: I agree.

Dr Skerritt : It would corrupt the process otherwise.

Senator ROBERTS: This is my last question on this topic before I move on to the second one. Were the COVID-19 vaccines ever tested on zero- to four-year-olds; and could you please provide a copy of the data to prove that the vaccine is safe for young children and babies?

Dr Skerritt : The vaccines are not approved for zero to four-year-olds. They have not been approved in this country or by any major global regulator. There is an approval in China for a Chinese-made vaccine, I think, down to age three. When I look at the US, Canada, Australia, Japan and Europe, they are not approved in that age group.

Senator ROBERTS: When will they be approved?

Dr Skerritt : It depends on the date that it's submitted to us and whether it's acceptable.

Senator ROBERTS: Are you expecting it at any time in the next three months, before the new parliament comes in?

Dr Skerritt : I can't predict that. We may receive an application mid-year, but it is really dependent on the completion of trials and on the quality of the data.

Senator ROBERTS: Let's move on then to the next topic. Can a COVID-19 vaccine enter and affect human DNA? A Swedish study—I'm going to table this—has demonstrated that it could. The paper, which is being distributed, at section 4 states:

At this stage, we do not know if DNA reverse transcribed from BNT162b2 is integrated into the cell genome.

So they're acknowledging that. The fact is that the Australian government may have not independently confirmed whether it does or not. So the question is: have you done so; have you kept us safe?

Dr Skerritt : We are familiar with this paper. It is actually quite widely discredited in the medical community for a number of reasons. Firstly, reverse transcriptase of the type required are not commonly found within cells or not commonly found within the nucleus; and, if this were plausible, you would argue, as I mentioned earlier, probably all of us sitting here have 20,000 genes and 20,000 mRNAs that are making various proteins at any one time and you'd have all those proteins clogging up the nucleus. The second issue is that the amount of messenger RNA used in this study was not at physiological levels; it was a very high level of messenger RNA. This paper was published in a second- or third-tier journal and it has been fairly widely discredited. Again, I'm happy to provide a bit more information on what experts in the field have said about this particular study.

Senator ROBERTS: I'd welcome that. But my question was not whether the paper was good or not. The question is: has the Australian government independently confirmed whether the material does transcribe or not? So my question was: have you done that; and have you kept us safe from any possibility of that?

Dr Skerritt : We do not believe that it can plausibly—

Senator ROBERTS: So that's a belief.

Dr Skerritt : The scientific evidence does not show—

Senator ROBERTS: Could we see that scientific evidence, please?

Dr Skerritt : Yes.

Senator ROBERTS: Please take that on notice.

Dr Skerritt : I'll take that on notice, yes.

Senator ROBERTS: Secondly, did the TGA issue authorisations solely based upon the basis of the manufacturer's data?

Dr Skerritt : Which vaccine are you talking about?

Senator ROBERTS: Pfizer.

Dr Skerritt : Every medical product is reviewed on the basis of a submission that a company or other sponsor makes. In every case, there are many questions—in the case of one of the COVID vaccines, I think the questions numbered in the hundreds—where we go back and request further data. We also look at data from studies. If a vaccine is, for example, already on the market—as Professor Murphy mentioned for AstraZeneca and Pfizer—for use overseas, we look at that data. The process is that the data does come from the organisation that submits it, but we don't take it at face value. We drive pharmaceutical companies crazy by asking them dozens and quite often hundreds of questions and ask for more things.

Senator ROBERTS: Why did the TGA just refer to the manufacturer data and take their word for it? I know that you just said—

Dr Skerritt : As I said, we don't take their word for it; otherwise we'd just be a rubber stamp and you might as well not bother having a TGA.

Senator ROBERTS: That's my concern.

Dr Skerritt : We are not a rubber stamp. What do those people do all day? I think it's fair to say that, at the time we were reviewing the vaccines, we had teams of people working seven days a week, so they were extremely busy reviewing hundreds of thousands of pages of data. They are very highly qualified people.

Senator ROBERTS: My concern is that there have been so many contradictions, so many reversals of data, so many denials, so many orders, so many instructions and so many absurdities throughout this whole period of COVID, and I'd call it a 'mismanagement'.

Dr Skerritt : That's your assertion.

Senator ROBERTS: That is my assertion. There have been so many absurdities and so many contradictions. We've got one state contradicting another state and we've got one state contradicting itself over a period of weeks. We've got so many of these that people are rightly very, very suspicious and concerned.

Dr Skerritt : I would also add the fact that Australia, of course, has a very high vaccination rate and, while there are some individuals who are suspicious or concerned about the data, the massive majority of Australians have chosen to become vaccinated. I'd also add that there is one national medicines regulator who has the role of looking at the safety, efficacy and quality of vaccines.

Senator ROBERTS: My next question is from many constituents, and I'd like to table these, please. I'm not tabling the questions; I'm tabling a handout, listing reports and scientific publications on the toxicity of graphene oxide to living organisms.

Dr Skerritt : Yes, it's toxic.

Senator ROBERTS: My constituents have asked me to ask you about a recent UK study, which has formed the basis of criminal charges in that country due to the presence of compounds, including graphene oxide, in COVID-19 vaccines. Graphene oxide is not on the ingredients list. Have you tested specifically for graphene oxide or other unlisted chemicals in the COVID-19 vaccines?

Dr Skerritt : We and other regulators globally have assessed the vaccines. There is no graphene oxide in any of the vaccines.

Senator ROBERTS: Have you tested?

Dr Skerritt : I would have to take that on notice, but we have no evidence. We do—

Senator ROBERTS: You have no evidence, but have you tested for that?

Dr Skerritt : I said I'd have to take that on notice. But I am absolutely confident that there is no graphene oxide in vaccines. Why on earth would you put it in there?

Senator ROBERTS: That's what people are wanting to know.

Dr Skerritt: Yes, why on earth would you do that?

Senator ROBERTS: We were talking about—

Dr Skerritt: It sounds like some conspiracy theory again, Senator.

Senator ROBERTS: That's usually used as a term to ridicule the person asking the question.

Dr Skerritt: It is, yes; and I'm using it that way. To think that someone—it is not directed at you, Senator—would put graphene oxide into a vaccine would amount to a conspiracy theory.

Senator ROBERTS: We may have some interesting material for you at the next Senate estimates.

Dr Skerritt: Thank you, Senator.

Senator ROBERTS: You've already explained that graphene oxide is toxic to humans.

Dr Skerritt: Yes.

Senator ROBERTS: With respect to Professor Kelly's response to Senator Rennick's questions about people wanting to go overseas being denied going overseas because of our global commitments, I've heard that so many times, Minister, including from the previous leader in the Senate, Senator Cormann. In answer to my request for data as to why we're complying with UN requirements and UN policies, I am told it is because we have to comply with our global commitments. Am I to understand that the omicron variant entered Australia at a time when only vaccinated people were allowed into the country?

Prof. Kelly: That's correct, Senator.

Senator ROBERTS: Thank you. That's all from me right now. I'll come back with ATAGI.

CHAIR: We will go to Senator Grogan next.

Senator GROGAN: What additional regulation of vaping products is the department exploring as part of the National Tobacco Strategy?

Dr Skerritt: I won't talk about the strategy writ large, but, as you're aware, additional regulation about vaping products was introduced effective 1 October last year, wherein all people, for a nicotine-containing vaping product, require a doctor's prescription. The intent there was to limit its recreational use, because vaping is harmful, for individuals to have the best discussion you can have, in wanting to give up smoking, as a discussion with your doctor or other health professional, and, of course, to limit or prevent children and adolescents getting access to vaping. There are people illegally importing the product. We have a major exercise underway with the Australian Border Force.

Senator GROGAN: Minister, you may be able to help me with this one. Are you aware of who signed in to Parliament House during the February sittings, from the 7th to 18th, the Australian Taxpayers Alliance and Legalised Vaping Australia lobbyist Brian Marlow?

Senator Ruston: I would have no idea, Senator.

Senator GROGAN: It was a period when lobbyists weren't allowed in the building. I think that he was here for some meetings, but I'm concerned about what that sign-in process was. No idea?

Senator Ruston: No, Senator. Obviously, I'm sure there is some process of recording who signed who into this place, but I have no idea.

Senator RENNIC K: My question is for ATAGI. Why is ATAGI making rules around mandates in regard to exemptions when the federal government have stated on a number of occasions that they don't believe in mandates?

Prof. Crawford : ATAGI provides advice to government around the use of the COVID-19 vaccines and what the recommendations are to be up-to-date for vaccination. We've not been involved in the decisions around mandates or been asked to provide recommendations to government around mandates; that's not under the remit of ATAGI.

Senator RENNICK: State governments often use the ATAGI exemption guidelines as their basis for mandates, as do employers. I know you may not be directly involved with the mandates, but by giving exemptions and setting the criteria—and very narrow criteria, too, I might add—we have scenarios whereby people have a severe reaction to the first vaccine jab, get injured, are too scared to get a second jab, and go back to their employer. The employer says, 'You've got to get a second jab or you lose your job.' In the end they lose their health and their job.

Prof. Crawford : ATAGI provides advice around medical exemptions, which is not just for COVID-19 vaccines; it's also around other vaccines that may be recommended in childhood. There is some advice around that. That includes essentially a temporary exemption in the setting of a reaction to a vaccine, as you allude to, as well as the interval post having had an infection, in terms of the time line for recommending consideration of revaccination. But it's very much about the individual clinician and that individual going to them to discuss the medical exemption, and there are criteria around how that form is signed. ATAGI does provide advice that goes into that form, but how that is directed goes back very much to the physician that's managing that individual.

Senator RENNICK: Why do ATAGI give temporary exemptions? At the end of the day, if you've had an adverse reaction to a vaccine, what's to say in 12 months time you're not going to have the same reaction, assuming it's the same chemicals in the vaccine and it's the same person? I can't, for the life of me, understand why you're only making it temporary, because there are people out there who are terrified of having to go back and get a vaccine. They know they've got to face up to that day if they want to keep their job, if they want to see their grandparents, or something like that. For the life of me, I cannot understand the science behind a temporary exemption where someone has been injured prior. If they have a reaction, they have a reaction.

Prof. Crawford : In terms of that exemption, it's often in a setting of acute medical illness. If someone has an acute, major medical illness and is unwell, they may also have a temporary exemption to their vaccination at that time point. It's about giving them time to recover from that event and then having that one-on-one discussion. I think it very much goes back to that individual and a discussion with their physician. It may be their primary care general practitioner or their specialist that's involved in managing their underlying medical condition, but I think it's best that those discussions happen at that individual level. That guidance is just directing clinicians to allow them to have that discussion. Someone may have recovered from that illness. They may want to reconsider vaccination within that window, and they need to have that discussion, depending on the example—

Senator RENNICK: I totally agree with you; the discussion should be with the doctor, and hence my point: why is it that ATAGI are defining those exemptions? And they are very narrow. That's the point: They may have a reaction, and who knows what the adverse event may be? But many of these adverse events don't fall within the categories defined by ATAGI. As you've just said, they should talk to their doctor, which I totally agree with. It should be about the right of the individual in consultation with their doctor. Why is ATAGI overriding that? You may not yourself be overriding it, but employers and state governments are using those exemptions set by ATAGI to justify why they do what they do.

Prof. Crawford : In terms of the interpretation, that needs to go to the groups that are doing that. Again, the individual discussion is very much around what's occurred with that individual, what's happened in terms of that reaction, and the discussion around the reaction as it occurred. You can give another temporary exemption to that individual, if indicated. In terms of the conditions that it's assigned to, it is very much looking at the reports that have come in from the TGA. What are the adverse events recognised with the vaccine and which is the window for those exemptions to continue? Again, ATAGI is constantly reviewing the evidence base around that and providing advice on the basis of that evidence as it emerges and changes.

Senator RENNICK: If someone has a reaction on day one, what's to say they won't have the same reaction? They may recover, whether it takes two weeks or three months. What's to say they won't have the same reaction in 12 months time?

Prof. Crawford : That again goes back to that individual discussion. Wearing my other hat, I see patients with reactions in clinic. Some of them may have clearly had an allergic reaction. They may be concerned that they had an immediate reaction to a vaccine. It doesn't necessarily mean that the vaccine has definitely triggered it, and it may be that it's okay to reconsider an alternative platform in a vaccine. We have multiple vaccines now being made in different ways. It may be that a different type of vaccine may be applicable to that individual. It's really about coming back to that individual discussion. Reaction may have occurred on day one, but there may be an alternative that could be considered in that four-to-six month interval for that individual to still be protected. The aim of the immunisation recommendation is to protect individuals from severe disease.

Senator RENNICK: That's the thing. But the alternative may be that it's not in their best interest to take another vaccine at all, and you're not giving them that option.

Prof. Crawford : The advice is around the medical exemption. In terms of having other vaccines, we're not forcing or having that pushed onto individuals through the advice. We're very much just giving guidance for clinicians around those exemptions. I have to come back to that individual—

Senator RENNICK: But the problem with that is that doctors rely on that guidance and they use that as an excuse. I'll quote one person that contacted me, a constituent, who said that she got a four-month exemption and when she went back for another exemption the doctor wouldn't give it to her. He said, 'I'll only give you one exemption.' She was then faced with this problem of having to go back into anaphylactic shock on the second shot. We just can't have these cruel and unnecessary measures coming from our own governments.

Dr Murphy : I can't believe a doctor would not—if someone had an anaphylactic reaction the first time—

Senator RENNICK: I have been told numerous times, Dr Murphy, that people have had anaphylactic shocks and they have been told by their doctors to go and get their second shot in emergency, so that they're already there in the hospital.

Senator Ruston: Senator Rennick, the anecdotal evidence that has been provided here by you is very serious. It makes it very difficult for the officials to be able to respond when you're just saying this is something that somebody has told you. If you actually have evidence that you can provide—obviously, we can't do it in session because we don't want to names. But if you are able to provide the names and the details of the people who have provided you with this information and the name of the doctor who has allegedly done what you're saying, I think they're very serious matters and they should be followed up. But prosecuting it here when we're just talking about somebody saying something makes it—

Senator RENNICK: I'm using it as an example, Minister.

Senator Ruston: The problem is, Senator Rennick, that the example you are using is very serious. To suggest that a doctor would actually put somebody knowingly at this kind of risk is something that needs—

Senator RENNICK: That's fine.

Senator Ruston: If you could provide us with the names and the doctors—

Senator RENNICK: I'll get the names and addresses; don't worry about that.

Senator Ruston: And the situations to allow the officials to be able to look at it, I think that would be fair.

Senator RENNICK: Minister Ruston, I'm more than happy to do that. I will get that data; no problem. I've got another question. Let's move on to natural immunity. Prior to Christmas, natural immunity exemptions were given for six months, if you had COVID and recovered. In late January ATAGI changed that to four months. What is the science behind natural immunity in terms of changing the exemption period? I think that originally it was three months, back in November; it got changed to six, and it's back to four. I don't want to quote particular studies, but there are plenty of anecdotal studies out there that suggest natural immunity lasts for much longer. There's the argument to say that, if you've recovered from COVID once, you'll recover again. Yet again, why isn't natural immunity being recognised as a much longer term form of protection and why is ATAGI changing the rules around natural immunity?

Prof. Crawford : Thanks for the question. The recommendation to move from six months to four months came at the end of last year. Essentially, in late November-December we were obtaining evidence that if you'd had a previous delta infection, which was our main variant of concern circulating towards the end of last year, you weren't well protected from omicron. Those that had the infection in, say, October-November were not going to be protected in February-March from omicron, which was becoming the emerging wave. Rather than waiting for six months, which from November would have taken you to May—so not even now would you be recommended a vaccine dose—we recommended shortening that interval to four months. Now that we're in a position where omicron is clearly the main variant circulating, that is currently being reviewed by ATAGI. Again ATAGI continues to meet weekly to review emerging evidence both in terms of the epidemiology and in terms of the vaccine, and reviewing the time lines and interval. This is a common question. It is a good question and it is something that ATAGI is reviewing. As we come to those deliberations, the government will provide that advice.

Prof. Kelly: I understand, Senator, that some epidemiological evidence from Israel in particular is the opposite of your contention there, that actually natural immunity in general does not last, and it does not last as long as particularly three doses of vaccine. This is the sort of evidence that Professor Crawford has been talking about.

Senator RENNICK: I'd argue that a lot of people in Israel have had multiple boosters, but we'll leave that to one side. Last question: if you have recovered from COVID, what's to say that you won't recover from COVID again? Why can't people say, 'I've recovered once. Why do I have to take a vaccine every three months in order to keep up my protection?'

Prof. Crawford : Again, this is related to the interaction between both vaccination and wild-type infection. Clearly, until the omicron variant, we didn't have such widespread circulation of the virus. We know there are some sero-surveys now going on, particularly through the blood bank and other places, to try and understand how much of the population has been exposed. That will impact on our deliberations around the timing of vaccines. We do agree that it would be good to get to a place where we weren't having to think about vaccines at such a frequent level, but we really have to wait and see how things progress. Again, watching international experience, seeing what's happening in different countries and their recommendations will hopefully take us to a place where we can set the vaccines in terms of the number that are required and the time lines. But, to be honest, we're just not quite there yet. It's very much a matter of watch, wait and see. I totally appreciate that we're likely to be coming to a place where we understand the timing of the vaccines and that duration, in the setting of both infection and multiple doses. For the majority now, it's three doses, with some now having a fourth winter dose.

CHAIR: I've got a few quick questions that I'd like to ask. I'm not sure whom I'll need to ask the questions of. They are in regard to the vaccination policy for the Australian Electoral Commission for the temporary workforce for the election.

Prof. Kelly: Sorry, could you repeat the question?

CHAIR: It's not actually a question yet. I'll ask it now. I understand the AEC is actually requiring all of their 100,000 temporary staff to be vaccinated. Did they actually seek advice from you on that prior to requesting that?

Prof. Kelly: My understanding of that—of course the AEC is an independent body to an extent and we have been working with them closely—is that my colleague, Professor Michael Kidd, who may be online, would be able to give some further information?

Prof. Kidd : The question, I understand is about the advice that we provided about the vaccination of the workforce working in the polling booths. That's correct?

CHAIR: That's right. There are 100,000 or so temporary staff that will be required to have had vaccinations.

Prof. Kidd : That's right. We have been meeting regularly with the Australian Electoral Commissioner and his staff throughout the pandemic in relation to the by-elections and also in preparation for the federal election. We provide advice, as Professor Kelly indicated. We don't, of course, dictate what the Electoral Commission should be doing. We have provided recommendations about the vaccination of all the people working in the polling centres as well as other public health measures to protect those people. Obviously the responsibilities, the occupational health and safety responsibilities for the people working in the polling stations are the responsibility of the commission.

CHAIR: You've said you met with them regularly. How long ago, or when was the advice first requested and provided?

Prof. Kidd : I'd have to take on notice when the actual meetings have been held. People from the department—I and, previously Dr Catherine Kelaher—have been meeting probably each month over the past six months or so, and we've had previous meetings as well. We've also had the Electoral Commission come and speak to the Australian Health Protection Principal Committee to talk about the arrangements in each of the states and territories during the federal election.

CHAIR: Have you met with them recently? Has that advice been updated with the omicron variant and so on? That obviously has made an impact.

Prof. Kidd : Yes, absolutely. We have met with them since the rise of the omicron variant. We'll be meeting with the commissioner again tomorrow.

CHAIR: Do you think it is necessary that a mandatory vaccination policy for AEC staff be maintained?

Prof. Kidd : As I mentioned, this obviously is a decision of the commissioner, who is responsible for the health and wellbeing of the people working in the polling stations.

CHAIR: I understand that the Biosecurity Emergency Determination, obviously which it is issued under, will not be renewed after 17 April 2022. What impact will that have on the validity of a blanket vaccination policy? Would that impact?

Prof. Kidd : I may refer that back to Professor Kelly if that's okay.

Prof. Kelly: The question is about the change in posture of the Biosecurity Act determination. If I may, I might slightly correct the record from what I said previously to a question from Senator Roberts. There are a number of changes in relation to the Biosecurity Act. Previously unvaccinated Australians were allowed to come into the country but needed to quarantine. I just wanted to clarify that previous answer.

Senator ROBERTS: But the vaccinated were allowed to just come in.

Prof. Kelly: The vaccinated were allowed to just come in, without quarantine, yes. Your question, Chair—apologies—is that specifically in relation to the AEC posture?

Dr Skerritt: The Biosecurity Act.

Prof. Kelly: I'm not sure that it really changes things. There are changes coming in on 18 April in terms of the end of the emergency period but there remain some elements of the Biosecurity Act in relation to non-emergency powers. But I don't think any of them actually relate specifically to this matter. I think at a state and territory level, though, there are many of the states and territories that do rely on their emergency periods continuing. Some of those mandating elements may well lapse, I understand. But that's really a matter for the states and territories.

CHAIR: At the moment the only mandating vaccinations are required for aged care and healthcare, is that correct?

Prof. Kelly: That's correct. That's not related to the biosecurity period. That was a decision made by National Cabinet on the basis of advice from the AHPPC specifically related to those very highly vulnerable populations.

CHAIR: So the AEC need to have direction but obviously, from what Professor Kidd said, there will actually be a meeting tomorrow. I'm assuming that they will be provided with relevant advice at that meeting. Obviously the task of hiring 100,000 people in the next few weeks will be unenviable anyway.

Prof. Kelly: It's tricky. But as Professor Kidd said, we've been very clear with them about the advice and the pros and cons of vaccination. Ultimately the AEC, amongst its various other important functions, is an employer of those 100,000 people with the legal responsibility under work health and safety laws which they need to take into account. It's up to them to make that decision.

CHAIR: We'll hear after tomorrow what the outcome is. Thank you very much for that.

Senator ROBERTS: Chair, can I ask questions of ATAGI?

CHAIR: I'm concerned that we've just had an influx of senators into the room and if they're expecting to ask questions. We're due to finish this section at 12.15 and we've already gone an extra hour over it. Just so that you know, I will be stopping at 12.15. I'm now going to Senator Roberts.

Senator ROBERTS: Thank you. Let's get through this quickly then. I'd like to table this. My questions are for ATAGI, because that's where I was directed by the gentleman at the table now. It's in regard to AHPRA. This is from their website. I've also got another page from their website which I'm not tabling, but I'm happy to do so, if needed. Dr Crawford, are you there?

Prof. Kelly: He is. But an AHPRA question may not be relevant to ATAGI. Ask your question and we will see.

Senator ROBERTS: I'll ask the question of everyone then. This is on ATAGI and national boards, a position statement from AHPRA. It goes back to 9 March 2021, right from the start, pre-vaccine:

While some health practitioners may have a conscientious objection to COVID-19 vaccination, all practitioners, including students on placement, must comply with local employer, health service or health department policies, procedures and guidelines relating to COVID-19 vaccination … National Boards regulate individual practitioners and not health services or state and territory health departments.

Down at the bottom of this notice it says:

Any promotion of anti-vaccination statements or health advice which contradicts the best available scientific evidence or seeks to actively undermine the national immunisation program (including via social media) is not supported by National Boards—

and the doctors read this—

and may be in breach of the codes of conduct and subject to investigation and possible regulatory action.

That was very, very clear. Then there's a social media guideline, which I won't go through now.

Is anyone aware of John Larter, who is an experienced paramedic who took a vocal stand against mandatory vaccination in his industry—against mandatory vaccination? AHPRA moved swiftly on him and Larter told the media that he was not even given an official reason for his suspension when it happened.

Ros Nealon-Cook is a psychologist who took it upon herself to warn Australians on social media of the severe and widespread harm being caused to child development and mental health by prolonged lockdowns. She was instantly suspended for her trouble.

The more concerning one—these are all of concern—is the one in August 2021. The COVID Medical Network published an open letter titled "First Do No Harm". The COVID Medical Network's open letter did not list any authors; so AHPRA went to the Australian Securities and Investments Commission, ASIC, and found out the names of the three directors of the COVID Medical Network. Two were doctors, and their medical licences were immediately suspended.

The COVID Medical Network was formed in 2020 to provide the public with informed, evidence-based advice concerning lockdowns and other matters that differs from the government and its bureaucratic instruments. The organisation runs a weekly videoconference that is tuned in to by hundreds of Australian health professionals.

One of the doctors who was suspended, Robert Brennan, was given written reasons for his instant termination. AHPRA accused him of spreading 'medical misinformation' via the COVID Medical Network open letter because—these are the words that AHPRA used—'the content of both the letter and the video are contrary to New South Wales public health orders'. I'll say that again: 'the content of the letter and the video are contrary to New South Wales public health orders in force at the time and have the potential to undermine public health strategies by potentially influencing medical practitioners and the community not to be vaccinated'.

Then they go on, AHPRA, to say:

It is not our role to evaluate the scientific validity of the letter. Our concern is that the letter strongly argued a highly polarised position contrary to the public health order.

In other words, the position argued by Dr Brennan and the COVID Medical Network might be scientifically correct and the position of the Australian government scientifically incorrect but as far as AHPRA is concerned the crime lies in contradicting the government's position.

CHAIR: Senator Roberts, do you have a question?

S enator ROBERTS: Yes, I do. Why is AHPRA allowed to do this and what are you doing to make sure AHPRA is held accountable, because they are not, as far as I know, to the parliament?

Dr Murphy : AHPRA is a creature of all governments; so it's a creature of all the state and territory governments and the Commonwealth government. And it has a range of boards of experts. There's a medical board and there are boards of nursing and para-medicine. I think the message really is in that final statement that said that promotion of statements or advice that contradicts the best available scientific evidence or seeks to actively undermine the national immunisation program have been determined by AHPRA and by its expert boards as being unprofessional conduct, and we would support that contention by AHPRA.

Senator ROBERTS: Can I get access to that evidence from AHPRA?

Dr Murphy : What evidence?

Senator ROBERTS: That it's the best scientific evidence.

Dr Murphy : I think the best—

Senator ROBERTS: There is so much—

Dr Murphy : I think Professor Skerritt has been giving the best scientific evidence all morning about the benefit of vaccination. I think there are scientific standards that are well established in the literature—

Senator ROBERTS: Can I get the evidence, not statements and opinions about the evidence? Can I get the evidence?

Dr Murphy : We can give you lots of evidence.

Senator ROBERTS: No, no. Can I get AHPRA's evidence they're touting? Remember, Dr Murphy, it's not only what might be scientific; it is also about the contradiction of the public health statement.

Dr Murphy : If you would like to provide that information to us we can investigate it, on notice, and go back to AHPRA and understand what your—

Senator ROBERTS: Provide what to you, this information?

Dr Murphy : Yes.

Senator ROBERTS: Okay.

Dr Murphy : If you can provide it to us we can follow it up.

Senator ROBERTS: Final question—

CHAIR: Senator Roberts, I am just conscious of time because I have got four other senators now wanting to ask questions.

Senator ROBERTS: I'd like to know why ATAGI is not here in person. Also I'd like to know—

Dr Murphy : Professor Crawford is here online. He is actually based in Melbourne.

Senator ROBERTS: Thank you. That's all I needed to know. I'd like to know the relationship, Dr Murphy, between the boards, AHPRA and the AHPPC. And the final question: 'public health' is quite often used these days in America and in Australia as a catch-all for the community. That's why orders are given and people are supposed to follow them. But 'public health' is a nonsense. It's not an entity. The primary public health goes back to the primary relationship between a doctor and a patient. In this country now are you aware that there is not a relationship between many doctors and their patients because the doctor has got a puppet-master behind him telling him what he can or cannot say?

Dr Murphy : The individual relationship between a doctor and his patient is sacrosanct and AHPRA would not have any problem with a doctor having—

Senator ROBERTS: Dr Murphy, they have.

Dr Murphy : AHPRA would not have a problem—

Senator ROBERTS: They have.

Dr Murphy : with a doctor having an individual discussion with his or her patients around vaccination.

Senator ROBERTS: So—

CHAIR: Senator Roberts!

Dr Murphy : What this is talking about is the public promotion of misinformed and wrong scientific evidence. That's what they're concerned about: bringing the profession into disrepute and undermining public confidence.

Senator ROBERTS: What I'm talking about is—

CHAIR: Senator Roberts, your time has expired now.

Senator ROBERTS: Just one minute.

CHAIR: Senator Roberts!

Senator ROBERTS: What I'm very concerned about is doctors who are telling me personally that they cannot give advice because AHPRA is sitting behind them. What they are getting is a public health dictate when they go to their doctor, not advice.

Dr Murphy : If you can provide evidence of that—

Senator ROBERTS: Yes, I will.

Dr Murphy : we are happy to investigate it.

Senator ROBERTS: Whom do I provide it to?

Prof. Kelly: I'm very happy to provide a definition of public health, as a public health physician. It is actually a recognised AHPRA profession, and I and others in the department have that. I would refer to my opening statement about the definition of a public health physician, what he does and how that works. It's about protecting the population at the population level and preventing death at the population level. That is not in any way to take away the importance, absolute vital importance, of an individual doctor/individual patient relationship. It's a different part of the profession.

CHAIR: Thank you.

Senator GROGAN: Going back to vaping, I am aware of five contracts for the vaping campaign: with Mediabrands Australia, Carers Australia, Ninti One, the Ethnic Communities Council and NACCHO. What is the campaign going to be and when is it going to go live?

Dr Skerritt : Those campaigns, in many cases, are completed. We are very proud of them. We realised that cigarette smoking and vaping are often associated with groups of a lower socioeconomic class. As a category, there is a strong correlation in terms of smoking rates and SES status. There is a disproportionate level of smoking among Aboriginal and Torres Strait Islanders and in some ethnic communities. It is variable, depending on the ethnic community, but in some ethnic backgrounds the rates of smoking often reflect the rate of smoking in the countries where they and their parents or their families and friends may have come from. Before the changes were introduced in October and in the first few months of their introduction we thought it important, for those dealing daily with patients from an Aboriginal or a very low SES background, to explain what the changes were, and then to explain to those patients, together with their doctor, that if they want to try vaping as a means of smoking cessation, this is how you go about it. That was essentially theme of each of those campaigns.

With Carers Australia, again that was a way into the caring and disabled community; Ninti One with Aboriginal and Torres Strait Islanders; FECCA with the ethnic communities; and NACCHO with a different group of Aboriginal and Torres Strait Islander health professionals. We have done some evaluation together with them. They were fairly modest contracts.

Senator GROGAN: Yes. I think the total value of them was $465,000.

Dr Skerritt : Only a couple of hundred thousand. We worked with the senior executives of the organisations. They co-invested their time into the campaigns. You only have to talk to most Aboriginal and Torres Strait Islander health professionals and they say, 'If we can reduce smoking rates, it's a really high priority.' So they were delighted to partner with us. We provided some small funding to help organise things like webinars and so forth. We will probably do a similar thing again.

Senator GROGAN: Are all of those completed now?

Dr Skerritt : There are still a few bits and pieces. Obviously, to use the communications term, the collateral, the information for webinars, for posters, is still available. If you go to the Aboriginal Health Service, that information will be available to them. So some of those things are durable. You sometimes have to do these things several times. I do intend for the life of this group, or other groups that identify themselves as having access to a group who are resistant smokers, that we will fund similar communications and education campaigns. We are very proud of them.

Senator GROGAN: Thank you.

Senator ABETZ: On vaping, as it were, with the new regulation there is still a degree of uncertainty. Can I have an explanation as to why nine questions remain unanswered from the October estimates?

Dr Skerritt : I can't answer that.

Senator ABETZ: Can you please take it on notice?

Dr Skerritt : We've fully answered them on time and they are in the system somewhere.

Senator ABETZ: Can you please take that on notice?

Dr Skerritt : We can.

Senator ABETZ: The draft consultation of the National Tobacco Strategy 2022-2030 does not mention the Therapeutic Goods Administration's role in the regulation of nicotine vaping products for smoking cessation. Is that an oversight?

Ms Rishniw : It is not an oversight. The National Tobacco Strategy is a strategy that is out for consultation. It has been developed by the Commonwealth and the states and territories. It looks at a range of measures in terms of how we get to the target of reducing smoking rates by 10 per cent by 2025.

Senator ABETZ: Are we still in denial that vaping is a good methodology in relation to that, as witnessed by so many people who come to my office, and who speak about it publicly?

Ms Rishniw : The government has introduced a range of measures looking at smoking cessation, one of which includes vaping.

Senator ABETZ: But why isn't that then in the draft consultation strategy?

Ms Rishniw : It is a strategy that has been drafted with all states and territories and Health.

Senator ABETZ: I know that.

Ms Rishniw : There are a range of cessation—

Senator ABETZ: That doesn't explain why vaping is not included in the draft strategy. Please answer the question.

Ms Rishniw : There is a range of cessation mechanisms in the strategy.

Senator ABETZ: Yes, but vaping is not.

Ms Rishniw : Vaping is just one of a range of cessation measures. The government has made a number of commitments to that, which include working with the Cancer Council of Victoria and with the TGA.

Senator ABETZ: We acknowledge that vaping is a cessation methodology. So in that circumstance, please explain why it is not in the draft strategy for 2022 to 2030?

Ms Rishniw : The strategy includes a range of cessation measures.

Senator ABETZ: Why isn't vaping in there? You have acknowledged that it is a cessation methodology; so why isn't it in the strategy?

Ms Rishniw : It is one of the measures that is part of a cessation program, Senator.

Senator ABETZ: But it is not in the draft consultation strategy, is it?

Ms Rishniw : I don't have the strategy in front of me. The strategy refers to a range of mechanisms.

Senator ABETZ: Yes. Yet again, is vaping part of that range? My advice is that it isn't. I want an explanation why vaping is not in that strategy.

Dr M urphy : Vaping is, as Ms Rishniw said, one of the means for assisting people to cease smoking—

Senator ABETZ: which is a welcome acknowledgment, from my point of view, finally.

Dr Murphy : It is. But our concern with vaping is more that it's being used and promoted as a new addiction and for people who aren't currently smoking. That's why we've been dealing with that.

Senator ABETZ: Yes, but my discussions here have at all times been about vaping as an assistance to reducing smoking.

Dr Murphy : It is taken up and we have strategies for GPs to prescribe vaping in a medically controlled frame. But the strategy is dealing with other approaches for smoking. Ms Street might want to comment on that.

Senator ABETZ: Time is, unfortunately, of the essence. Given the relatively low uptake of temporary MBS services for nicotine and smoking cessation counselling since 1 October—12,000 as I understand it, as at 31 January—when taken as a portion of the estimated 500,000 users of nicotine vaping products, does the department agree that more needs to be done to educate vapers and smokers and health professionals about the scheduling of nicotine vaping products for smoking cessation? It has not exactly been a hit, has it?

Ms Rishniw : The MBS items and the take-up of the MBS items Ms Shakespeare might comment on, but in terms of the range of cessation strategies, vaping is considered one of the mechanisms. It looks at a range of education mechanisms that we have in place with the Cancer Council of Victoria, with GPs and making sure that we've looked at a range of cessation mechanisms before you get to a vaping MBS item.

Senator ABETZ: With respect, I understand all that. I am talking about the uptake of 12,000 from about 500,000 users. By anybody's analysis, since October, which is about six months, that's a pretty low uptake if we are genuinely concerned, as I am, to reduce the rate of smoking in this country and improve health outcomes.

Ms Rishniw : We're equally concerned about reducing the rate of smoking across the country, and the government has committed to very clear targets in the prevention strategy and through the tobacco strategy. As I say, there are a range of mechanisms to reduce smoking. The provision of MBS services for vaping as one of the mechanisms is one measure in a range of mechanisms we use.

Senator ABETZ: Yes. I am specifically asking about vaping where there has been, on any analysis of the figures, a clear failure. On notice: would the Department of Health provide copies of all relevant information and training resources provided to GPs, psychiatrists and pharmacists about TGO110 and the scheduling of nicotine vaping products for smoking cessation, including the communication channels used to distribute these resources; that is, web, email, direct mail, et cetera? Then a final question: how many pharmacies are registered in Tasmania to prescribe vaping products? If so, what is the number?

Dr Skerritt: Pharmacists dispense, not prescribe; we are not in North Queensland.

Senator ABETZ: Thank you for that correction.

Dr Skerritt : To answer your question, people in Tasmania can obtain vaping products through an online pharmacy and overseas with the relevant personal import scheme approvals and an Australian doctor's prescription. We do not carry, because that's regulated under state law, oversight.

Senator ABETZ: You don't have any oversight at all?

Dr Skerritt : No. As I indicated in the last estimates, we don't have any oversight of the Tasmanian state system. The minister had written to his colleagues questioning whether Tasmania wanted to continue with their separate licensing; the Tasmanian government responded to say that they did. Many other states and territories have removed separate state and territory licences.

Senator ABETZ: I would have thought if you had a genuine interest in it you might have asked as to how many have taken it up. But you haven't. I fully accept that.

Dr Skerritt : We can find out for you.

Senator ABETZ: If you could, please. Thank you.

Senator PATRICK: I want to ask some questions about vaccine providers and the Vaccine Administration Partners Program Panel. There is a range of different entities: Aspen Medical, AusMed Health, the Vauxhall Super Clinic. It looks like someone is keen to help. Ms Blewitt, this is your area of expertise?

Ms Blewitt : Yes; let's see if I can help you.

Senator PATRICK: In terms of the vaccines delivered, have all of the entities on the panel list been contracted to do so?

Ms Blewitt : So the services secured?

Senato r PATRICK: Yes.

Ms Blewitt : No. Currently 82 have been registered; 27 of those have secured what we call enterprise orders, so that would be individual businesses that have secured the services of those vaccine providers. Let me check.

Senator PATRICK: Do you have any details about the performance of those providers? I am particularly interested in—I'll pick Aspen Medical—how much money they have been paid and how many vaccines they have administered?

Ms Blewitt : I don't have that information. But what I do know is when we allocate a vaccine provider, whether it be Aspen, HCA, or whatever, we do have reporting requirements. When we allocate them, for example to a residential aged-care facility, as part of that, in terms of administering doses they are required to report to us in terms of when they are done, how many they have done, how many doses we have provided with them, how many they didn't use—that sort of thing.

Senator PATRICK: The information I am interested in—I am happy for you to take this on notice—is the total cost paid to the provider for the provision of a service and the number of vaccines they have delivered as a function of that.

Ms Blewitt : I would have to take that on notice and do some analysis. Senator, I remember that you asked me a similar sort of question at one of the hearings before. It is complex in the sense that it is not a one-for-one. So when we ran the whole-of-government panel arrangement—I'm sure you're familiar with these sorts of arrangements—providers put in their price. That price will reflect on where they are delivering those services, the number of teams—there's a whole heap of metrics in there.

Se nator PATRICK: I understand there is complexity in that simple approach. You might find that someone in a remote location has a higher cost.

Ms Blewitt : Correct.

Senator PATRICK: That might be something you can visualise just in the name of the provider.

Ms Blewitt : Let me take it on notice. We'll have a look and see if we can get you some ranges.

Senator PATRICK: I am happy for you to put some caveats around it. I would like it for each of the providers that you have.

Ms Blewitt : That we have already secured, yes.

Senator PATRICK: I don't think it's commercial information in the context. I can walk into any shop and work out what the price of a drug is and make a choice. I wouldn't think that would be information in confidence.

Ms Blewitt : Leave it with me. We'll take it on notice and I'll see if I can get some ranges.

Senator PATRICK: Particularly in the circumstances where there are those variations associated with it. At least that gives me a guideline to perhaps come back and ask further questions. Thank you.

CHAIR: Thank you very much. One final senator to ask questions. Senator Smith.

Senator DEAN SMITH: Just briefly, Dr Murphy, I just want to go back a step. Why is it that AHPRA does not appear before estimates when in your early evidence you said it's a construct of state and Commonwealth government?

Dr Murphy : We have sought advice on that before. It is not a Commonwealth entity, as such. The state and territories and the Commonwealth are a party to it, but the way it was constructed is that it is not seen as a Commonwealth agency. We have no problem with AHPRA attending. We have explored that with AHPRA. They have attended many Senate inquiries voluntarily, including the recent inquiry into general practice. The advice we have been given is that at estimates it needs to be a Commonwealth entity. That was the advice we've been provided. We're happy to re-explore that. Personally, we would have no problem with AHPRA being here, but we have looked at it and we're advised that the convention is that to attend estimates you have to be a Commonwealth entity or a Commonwealth agency. For example, ATAGI is a committee of the Commonwealth government and it appears. We'd be happy to explore that further. The department has no problem with it, but that has been the protocol we've been advised.

Senator DEAN SMITH: Well, I'd argue that because AHPRA has appeared at a number of Senate committees there is a high level of interest and demand for scrutiny over a variety of activities that AHPRA is undertaking. Many of us know that from our own experiences, having had representations from constituents in the medical profession and others. If that advice back to the committee from you could find a way in which AHPRA does appear at estimates, that would be most favourable.

Dr Murphy : I think the essential nature of estimates—the Senate would obviously be much more expert than I am on that—is to examine the business of government and the expenditure of appropriations of the Commonwealth government.

Senator DEAN SMITH: I understand that.

Dr Murphy : That is not what AHPRA would normally fall into, but we are very happy to re-examine it. We have examined it in the past and the advice was that they can appear before all sorts of other Senate inquiries but not estimates.

Senator DEAN SMITH: Dr Murphy, where there's a will there's a way, and I heard you talk about a will.

Senator PATRICK: Do you have a Commonwealth official embedded specifically in AHPRA who could be called before estimates?

Dr Murphy : No, we don't.

Senator Ruston: Senator Smith, I take the point you're making, but I think what the secretary is saying is that it actually sits within the responsibility of the Senate more generally to make a determination in relation to this. It's not a matter for the secretary or for AHPRA to be making it.

Senator DEAN SMITH: Given that the secretary has fielded lots of questions in regards to AHPRA, I think that the Senate coming to a view about the advice or reflections of Dr Murphy would be most valuable; so I would like to see that.

Senator Ruston: All I'm saying, Senator, is that if this committee, formed as an estimates committee, as opposed to another committee, wanted AHPRA to come to a hearing—

CHAIR: We have tried.

Senator Ruston: then we probably should have sought to do it through—

CHAIR: We have tried and we have had the response that—

Senator DEAN SMITH: If the government doesn't have a problem and the secretary doesn't have a problem and there's no sort of legal impediment in regards to how Senate estimates are constructed then at the next estimates we welcome AHPRA very warmly.

CHAIR: I think we need to look into that. I know the secretary has definitely tried to approach them to have them appear and has—

Senator DEAN SMITH: The fundamental point is that senators believe there's not enough scrutiny applied to AHPRA and they're looking at every possible avenue to apply a high level of scrutiny to AHPRA and its practices.

Senator Ruston: I would also note that they have appeared before standing committees, but I take on board your—

Senator DEAN SMITH: Yes, that point has been made; that's right. But standing committees are not the same as estimates.

Senator Ruston: Senator, I was in the middle of making a statement and you interrupted me. I said that they have appeared before standing committees, but I take on board the messaging. It's quite clear from here that there is a desire for them to appear before this committee. I'm happy for that matter to be prosecuted, to see if there is a way that we can do it.

Senator DEAN S MITH: If the government has no opposition, that would be good to get on the record.

Senator Ruston: I don't think we do.

CHAIR: We'll follow that up before the next estimates.

Senator DEAN SMITH: Thank you.

CHAIR: That brings us to the end of programs 1.8 and 1.9. We are a few minutes behind time.

Ms Blewitt : Could I just update some of my evidence to Senator Grogan's question before about the scheduling of the residential aged-care facilities? I have checked with the team, so I can give you a bit more information. Is that okay?

CHAIR: Yes, definitely.

Ms Blewitt : Thank you. I have been able to confirm that for the residential aged-care facilities, for the winter dose rollout, in April we have allocated 578 facilities to VAP—vaccine administration providers—663 in May, 793 in June and 399 in July. Those numbers reflect the eligibility, recognising that when we did the booster program we completed our InReach at the beginning of February. You may recall that I mentioned in my earlier evidence that we went back and did a second round for 750 of those. I just thought it was useful to update that.

[12:21]

CHAIR: That's very helpful. Thank you. We will now move on to outcome 1, programs 1.1 to 1.7, including the National Rural Health Commissioner and the National Blood Authority. We are releasing the Australian Institute of Health and Welfare. We've had clarification that there will be no questions for them, and they have been advised. I will start with Senator Grogan.

Senato r GROGAN: I am going to start with the 10-year primary health care plan. I think we're all aware that it's never been harder or more expensive to see a GP. I just want to take you to the college of GPs' reaction to the budget last Tuesday in relation to the 10-year plan. I quote:

Tonight's budget simply did not live up to expectations on the 10-year plan. This is very frustrating given the time, resources, and effort we and many other health groups have put in over several years.

The consultation on this plan started in October 2019; is that correct?

Ms Rishniw : It started two years ago. I think Mr Cotterell will have the exact timing, but that sounds about right.

Senator GROGAN: And the public consultation closed in November 2021?

Ms Rishniw : Yes. There was an extensive consultation process with a range of different groups and a steering committee that included the RACGP, the AMA and a range of other stakeholders.

Senator GRO GAN: I think that's actually the college of GPs' point; that they've invested an awful lot of time and had expectations that this budget might deliver some funding to follow through on some of that. They went on to say:

The Federal Government has failed to provide much-needed funding to support vulnerable patient groups, including those with chronic and complex disease, and deliver on what is needed to ensure a strong future for primary healthcare in Australia.

So my question is: Minister Ruston, after nine long years in government, what's the plan for a strong future for primary health care in Australia?

Senator Ruston: The 10-year plan that is in place outlines this government's commitment to health care going forward. Obviously, everybody is entitled to their response to these things, and I respect that. I will not accept at all that the federal government has not made massive investments in health care across a range of different areas, whether it be the listing of PBS medicines, whether it be the support that's been provided to the states and territories to assist them in their response to COVID, the increase in their level of hospital funding and the measures that were in the budget. There has been a massive investment. No government has spent more on health care. No government has spent more on mental health care. No government has spent more on listing PBS medicines. I will not accept the fact that this government has in any way faltered in its commitment to the provision of health care to Australians and the support that it gives to states and territories, particularly around the support to hospitals and the health care that's delivered through the states and territories.

Dr Murphy : Ms Rishniw might identify some of the investments in the budget.

Senator GROGAN: So why do you think that the college of GPs is so upset then?

Senator Ruston: Obviously, everybody puts forward measures that they would like to have in the budget. Clearly, there were probably measures that they wanted in the budget that weren't there. I'm the representing minister here and I don't have the level of detail to go into prosecuting the particular specifics of the comments that were made by that organisation. I just wanted to be very clear around the investment that this government has made in health care across the board. I will not accept the fact that this government has not made, singly, the largest investment in health care for Australians of any government ever.

Senator GROGAN: If we go to the GP scenario, we know that the situation for seeing GPs, access to GPs, particularly in rural and remote areas, is becoming worse and worse. I can certainly talk to that for South Australia. The Senate conducted an inquiry. The draft report, or interim report, has been released. I accept that money has been put into various things, but what is the 10-year plan going to do to make it easier for Australians to see a GP? We are hearing over and again about the ability to get an appointment and that the cost of an appointment is escalating. We are seeing this particularly outside of the metro areas, even though things are ticking up in the metro areas as well.

Senator Ruston: I'll get Ms Rishniw to provide you with the more detailed stuff, but if you're talking about the regional workforce, we absolutely recognise that getting GPs into rural and regional areas is something that we are very keen to do, which is why there was $99.3 million in the budget to make sure that there were an additional 80 Commonwealth supported medical places that are targeted specifically to rural and regional areas. There's been a lot of work done around universities that are outside of the metropolitan area training GPs because we know that, if somebody is training in the country, they're much more likely to stay in the country. But there are other things that we've done: deregulating MRIs so that people are able to get access to MRIs in rural and regional areas, and renewed and expanded investment in the Royal Flying Doctor Service. There continues to be investment in rural and regional health. We will continue to make sure that rural and regional Australia is recognised in our health investment. To suggest that there is nothing going on I think is misleading the record.

Ms Rishniw : If I could add some detail in terms of the investment both through this budget and the broader 10-year primary reform care plan? The 10-year reform plan, as you mentioned, has gone through a range of consultation. I'll note that both the AMA and the RACGP and a lot of peak bodies, ACRRM, RDAA, NACCHO, all came out in support of the consultation and the final draft. It's a 10-year plan for reform. It goes to people-centred care and a modern future-focused health system. Over the last two years there's been over $1.7 billion invested in primary care that really builds the underpinning for the plan. The most—

Senator GROGAN : I hear all that.

Ms Rishniw : The most significant reform is telehealth.

Senator GROGAN: I hear all that and I read all the announcements. But what we are seeing on the ground is a reduction in GPs. We've been hearing some horrendous stories through—

Dr Murphy : We're not seeing a reduction in GPs, Senator.

Senator GROGAN: If I can just finish. We've heard some horrendous stories, through the senate inquiry, of the situation people are facing. I spend a deal of time out in the electorate of Grey, in rural and remote areas of South Australia. The stories we are hearing out there because the GPs are just leaving—there's a GP there who has been trying to retire for years and has not done so because he knows there's no-one to replace him. He's going to retire at the end of this year because he cannot keep going, and there is no-one to replace him. The concern is that you've got a plan that you've spent a couple of years developing, but we are facing a crisis. You've said there are 80 medical places for rural doctors. Have you done the analysis of what's needed? Is that going to solve the scenario that we are facing?

Ms Rishniw : I might turn to Ms Shakespeare, who is online. We put forward a comprehensive rural health strategy, and there is a range of measures in this budget, as the minister has alluded to. Ms Shakespeare is online, and she can talk about the specific measures in terms of regional and rural GP access.

Senator GROGAN: In responding to that, can you focus on when we are going to see it on the ground and when it is going to make a difference. Obviously, an additional 80 places—it's going to take some considerable time to provide boots on the ground.

Dr Murphy : Just before Ms Shakespeare starts, I would say that, whilst we absolutely accept that there are rural towns that have doctor shortages, the data supports that there has been an increase in the number of GPs over time in every modified Monash area. So the strategies that we put in place under the Stronger Rural Health Strategy are working, but there are a lot of strategies to get GPs and medical students to train in the bush. These 80 places are built on a range of pre-existing strategies that Ms Shakespeare can outline.

Senator Ruston: The other thing, Chair, is that we actually have a rural health plan recognising the issues that have just been outlined by the secretary, which I am happy to table. The fact is that we are about to go to an election, and I haven't seen any plan that would target rural health from the other side.

Senator GROGAN: You are the government! You have been the government for nine years.

Senator Ruston: We have a rural health plan. Senator, I don't interrupt you and I won't interrupt you, and I spoke the same courtesy. But we do have a rural health plan which I am more than happy to table here so that members of the committee can see the fact that we have absolutely understood that there are challenges in rural and regional areas. We have done things over the past two years, particularly in relation to COVID. The massive new investment in telehealth services is something that has been of great benefit to rural and regional communities. I'm recognising the fact that we do need to do more to make sure that we're supporting people who live in the country with health services. I totally acknowledge that, and that's why I'm happy to table our rural health plan.

CHAIR: Ms Shakespeare, I think, was going to add to that.

Senator GROGAN: Yes, particularly in terms of when these strategies are going to bear fruit.

Ms Shakespeare : I probably should just set out some of the statistics about the GP workforce. It grew from 34,811 across the country in 2015-16 to 38,388 GPs in 2021. That growth is not just in metropolitan areas. As the secretary said, we have seen growth across all modified Monash categories. If we look at GP FTE per 100,000 population, we are seeing growth in GP numbers. So I think the statistics show that some of these investments, through the Stronger Rural Health Strategy, are already bearing fruit.

I also think it's important to look at Medicare rebate information and the benefits that are paid for GP services. We were quite concerned at the beginning of the pandemic, when we had lockdowns, that people were going to stop seeing their doctors, but we have seen extraordinary growth in the number of GP services non-referred attendances and the benefits paid for those under Medicare. In 2019-20, GP non-referred attendances were reimbursed to the tune of $8.3 billion in Medicare rebates. In 2020-21, that increased to $8.8 billion. That is growth of 5.8 per cent. We don't have a full year of data for Medicare rebates paid for GP non-referred attendances for the current financial year. For the year-to-date data, we are seeing growth of around nine per cent. So we have more benefits being paid for primary care under Medicare.

We've got more primary care doctors. We certainly need to make sure that we're addressing local shortages. To date, we've had more than $1 billion invested under the Stronger Rural Health Strategy. It started off in 2018-19 with a $550 million package. There was another $123 million invested in the budget last year and around $300 million this year. There were further investments at MYEFO for programs to support HECS-HELP debt reimbursement for rural doctors and nurse practitioners. There has been a lot of additional work to recruit and retain doctors and other health practitioners in rural areas, and the data is indicating that it is having an impact. Of course, there's always more work to be done.

Senator GROGAN: I appreciate that your data might be telling you it is having an impact. Maybe it is having an impact in some places, but not in South Australia. We are seeing further decline in remote and rural areas, which is highly problematic. Recommendation 1 of the interim report from the Senate inquiry states that the federal government should further investigate the provision and distribution of general practitioners in rural and regional Australia. Do you have any intention to undertake that recommendation?

CHAIR: I doubt that they've read this report, so I doubt that it's—

Senator GROGAN: They may have looked at it, at the very least.

Ms S hakespeare : It was tabled in the last couple of days.

Dr Murphy : That was a major tenet of the National Medical Workforce Strategy. It's very much a part of our National Medical Workforce Strategy, which has been signed off by all governments recently. It is very much around dealing with the distribution of doctors into general practice versus other specialties, which is quite distorted. We've got too many of many specialties in the big cities and not enough people going into general practice. More particularly, we need all of those strategies to get doctors generally, and GPs specifically, into rural and regional areas. That is probably the biggest part of the National Medical Workforce Strategy, and we are already implementing that.

Senator GROGAN: The distribution is one of the critical challenges here—and the increasing number of trainee doctors choosing to go into specialisations and such like, and the reduction in those going into general practice. Could you talk to us about the workforce strategy and the idea of reassessing that distribution piece.

Dr Murphy : We'll be working with the state and territory hospitals, which are run by the state and territory health departments. They train most of the non-GP specialists because they are a service workforce in the hospital. I used to be the CEO of a hospital and I had six orthopaedic registrars because I had 100 orthopaedics beds. We don't need six new orthopaedic surgeons in Melbourne. So we have to work with the colleges. The colleges, and the states and territories, have all bought into this strategy to reduce the number of training positions for those specialties that we don't need. For example, we've already got agreement with the College for Emergency Medicine to do that. We're working with the heart surgeons society in order to reduce the number of trainees in cardiac surgery; we just don't need them. And then we have to replace that service workforce in the hospitals with a different type of medical workforce and marry that with the increased opportunities we provide every year to train people in general practice. And we need to make general practice attractive, particularly in the bush, by giving opportunities for medical students to study, train and have experience in rural general practice. Rural general practice is one of the most rewarding medical experiences but a lot of these young doctors don't actually see it. So we have a range of strategies to get long doctors out and have a six-month period, which the Commonwealth pays for, to immerse themselves in general practice. Frankly, if the other colleges are not training as many people, more will choose to go into general practice.

Senator GROGAN: That's great to hear. Another point we keep hearing about is the availability of housing and child care for doctors who are considering a placement in a rural or remote area. I have spoken to a lot of them out through the Iron Triangle and beyond. Being there 24/7, being constantly on call, cuts out a whole bunch of doctors from doing that. If they have caring responsibilities, if they have children, particularly if they don't have a partner who is staying home minding the children and taking responsibility for the family, it is really hard for them and they can't commit to what's required. Being a lone doctor on call 24/7 and with limiting housing opportunities—we've seen local councils purchase houses for doctors to tempt them to come. That is a radical measure.

Dr Murphy : What you're talking about is that model of the sole doctor in a country town who buys a practice, survives on that practice and is fully on call. Those wonderful 75-year-old GPs who have been doing that for 30 or 40 years are retiring, and young doctors are not prepared to do that. Ms Shakespeare can talk about a lot of the innovative models of care we're doing. We're looking at piloting practices which, in a number of towns, might bring doctors together. We are looking at innovative employment models. We might use a model where we pool Medicare income and state and territory hospital income to provide a salaried position that doctors can come in and out of. We have to look at new models of operation for rural general practice, particularly in those very small towns. Ms Shakespeare can tell us—

Senator GROGAN: I appreciate that offer but I'm very conscious of time. The chair will be giving me a shove any second now!

CHAIR: One more question!

Dr Murphy : We're as passionate about this as you are, Senator. The pressing issue for primary care is rural general practice.

Senator GROGAN: Absolutely; I couldn't agree with you more. But what are we doing right now for that chronic shortage that we are seeing?

Dr Murphy : Ms Shakespeare can give you some examples.

Ms Shakespeare : There've been some specific things done in South Australia recently in the way of 19(2) exemptions for remote locations to allow doctors to work across both primary care and hospitals. I think it would also be useful if I got Mr Rocks to go through some of the registrar training information about South Australia at the moment.

Senator GROGAN: I'm not talking specifically about South Australia; I'm just talking about my experience in terms of the people I have directly spoken to. Could we take that on notice? I can feel the time pressure!

CHAIR: I'm a hard chair! I might also touch on recruitment in regional and rural areas. Is support being provided for recruitment and retention for individual practices?

Ms Shakespeare : Yes. The Workforce Incentive Program operates at the practice level and through incentives to individual doctors. There are incentive payments available through that program. We also support practices with the recruitment and retention of doctors. It is not purely limited to doctors but there is a big focus on that through rural workforce agencies. I think we have between $25 million and $30 million a year supporting rural workforce agencies to support practices right across Australia. Some specific programs are being run through primary health networks in particular locations that have been experiencing difficulty in recruiting and retraining doctors.

CHAIR: Are there any situations where local GPs working in the community also work within their local hospitals, to complement the two areas?

Ms Shakespeare : Yes. We have the ability to issue exemptions under section 19(2) of the Health Insurance Act, which normally prevents a doctor who is employed under a publicly funded program—whether it is state government or Commonwealth government—from also billing Medicare for their services. We have a series of COAG 19(2) exemptions, which is a program to allow doctors to provide primary care services from rural and remote public hospitals. We're also increasingly using those 19(2) exemptions for flexible employment models which are more community based—so some of our innovative employment trials in New South Wales, in particular, allow a doctor to be paid a salary as well as bill services to Medicare where they are operating not out of the public hospital but out of a GP practice.

CHAIR: Is that just a trial at this stage, or is it something that has been embedded in the system across the country?

Ms Shakespeare : It certainly been embedded in the system for the COAG 19(2) exemptions. That's a longstanding program. The trials around the more innovative models in New South Wales are still trials.

CHAIR: Excellent.