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Standing Committee on Health, Aged Care and Sport
05/02/2021
Approval processes for new drugs and novel medical technologies in Australia

COOK, Dr Jane, First Assistant Secretary, Health Products Regulation, Medicines Regulation Division, Department of Health

MURPHY, Dr Brendan, Secretary, Department of Health

PEGG, Dr Grant, Medical Officer, Health Products Regulation, Medicines Regulation Division, Department of Health

PEISLEY, Ms Hope, Assistant Secretary, COVID-19 Vaccine Taskforce, Department of Health

SKERRITT, Adjunct Professor John, Deputy Secretary, Health Products Regulation, Department of Health

Committee met at 12:30

CHAIR ( Mr Zimmerman ): I declare open the House standing committee on Health, Aged Care and Sport. I want to thank our witnesses for joining us today. This hearing has been called as part of our broader current inquiry to provide us with a specific opportunity—to some degree as a case study—to look at the process in relation to COVID vaccines that's being adopted by the federal government.

I need to go through the usual formalities, so I need to remind you that, whilst you are not required to give evidence under oath, this is considered a formal processing of the parliament and the giving of false or misleading evidence is a serious matter. In some cases it might be regarded as contempt of parliament—and the punishment is reading cover to cover all 180 submissions that have been made to our current inquiry!

Before we get underway, I might just take the liberty to, on behalf of, I'm sure, the whole committee, thank all of you, particularly Professor Murphy and Professor Skerritt, for the work that you've been doing over the last 12 months. I think all Australians have been in awe of the support and the professionalism of health officials at both the state and federal levels in tackling something that we've never experienced before. We see that obviously in the extraordinary success that Australia has had to date. It's not often that Health department officials become household names and celebrities, but you've achieved that and achieved that for good reason. Professor Murphy, I know that Professor Skerritt is trying to catch up with his role in those advertisements with those lab coats! But all Australians are exceptionally grateful for the work that you're doing. I know it's been a 24-hour seven-days-a-week exercise. On behalf of us all, thank you. And thank you for making the time available today.

I understand that you don't wish to make an opening statement, but I thought what we'd do today—and we have Professor Cheng after both of you coming in via teleconference—is focus, from a TGA perspective, on the approval and regulatory issues of the vaccines and the matters arising from that and then also, from Professor Murphy, the vaccination rollout program. Hopefully, this committee will not only educate us but educate the broader Australian community as well. As neither of you want to make opening statements, I might just invite you, Professor Skerritt, to quickly give us an update on where the TGA is at with assessing vaccines. We obviously know about the Pfizer vaccine, but, for example, can you tell us anything about when AstraZeneca will be approved and other vaccines that you will be looking at?

Dr Skerritt : Thank you for the opportunity to give an update. To frame the process before we get down to specific vaccines, the product approval and safety decision process of the TGA around individual vaccines, as it is for all medicines and devices, is independent of the elected government. Their decision-maker is actually one of our most senior, depending on the particular product, medical officers. Clearly, while there's a single decision-maker, it's very much a process that's not only worked through extensively internally using information and discussion with overseas regulators—I tried to count how many meetings we'd had with overseas regulators since the beginning of COVID and at 150 I lost count. It really is that number; the most recent one finished at half past midnight last night. While we don't always end up with the same decisions as the overseas regulators, it's very handy to have a professional scientific medical discussion about, for example, pregnancy, variance, the bigger issue of age groups and so forth.

Because of the fortunate situation Australia is in, the TGA was able to conduct a full review of COVID vaccines rather than provide an emergency authorisation. That was not only because we weren't in the unfortunate position of many Northern Hemisphere countries and also Central and southern America, Africa and other countries but, most importantly, because we believe that that was important for confidence in the vaccine. I've said on a number of occasions that it's not vaccines that will save lives and reduce the spread of COVID; it's actually vaccinations. Of course, one of the major factors that the broader public and healthcare professionals are looking at is confidence that the process hasn't been rushed. It certainly has been done in shorter than normal time, and that's by doing certain things in parallel. Sadly, we've got a lot of extremely hardworking colleagues and teams, including the teams that my colleagues Jane and Grant lead, but it hasn't been rushed and corners haven't been cut.

We've looked in detail at the very significant amount of data that sometimes can exceed 10,000 pages for each of these vaccines. But it is a different situation, and we've been able to give full provisional approval. That might sound like a contradiction in terms. It's provisional because there are things we don't know about these vaccines: most importantly, the duration of protection. While there's some promising data that's come out in the last few days, we also don't have information on the degree of protection from transmission as opposed to from serious disease. So those factors, as part of a provisional approval, are things that the company has to continue to report to us. Indeed, they also have to report both local and international safety data every month, so we have these additional conditions to keep a very close eye on the development as we gain more and more knowledge of safety and efficacy of the vaccines

In the process of looking at vaccine efficacy—that is not only the clinical trial data but also data on antibody and cellular immune responses in individuals—quality is a very important issue: whether a vaccine is manufactured with sufficient purity, avoiding small fragments and contaminants of DNA, protein, lipid or other things that would be contaminants. The challenge with the vaccine is also to make sure it's made consistently at different locations. When we come to talk about AstraZeneca, as I will in a minute, while we will make a regulatory decision about the international AstraZeneca vaccine, we actually then have to turn around and start work to look at the locally manufactured AstraZeneca vaccine to make sure that AstraZeneca vaccine made in Europe and AstraZeneca vaccine made in Melbourne are exactly the same and therefore will have the same protective effects.

Safety is a major part of it. Apart from all the data that's been submitted to us from the company, which goes much further than what you might see in academic papers like the Lancet or elsewhere—that's why it's tens of thousands of pages rather than tens of pages—we also have had the advantage in Australia of almost eight weeks experience in some overseas countries. The really encouraging thing is that the serious adverse events—the serious but rare ones—generally appear four, six or a maximum of eight weeks after the vaccination, if they appear at all. We're not getting those signals, to use the jargon, and that's great news. That's not to say that there's no need to do safety monitoring. When we presented before a committee in the other place last week, I made the estimate that we're probably 20 per cent of the way through our work, not 80 per cent of the way. The 80 per cent is the ongoing monitoring of safety as these vaccines are rolled out and also the safety of other vaccines.

To finally come to where we are with specific vaccines, Pfizer, as you know, has received a provisional approval and there was the excellent news yesterday that, as part of an option in the agreement with Pfizer, subject to the TGA approval, the government was able to successfully exercise its option for another 10 million doses, making 20 million doses available. For AstraZeneca, the advisory committee which advises our decision-makers—and this advisory committee brings in a whole lot of vaccine, immunological and consumer specialists and representatives—met on Wednesday afternoon. The final advice has been signed off by the committee, probably as we all sit here; it has been done, or it's very close.

Dr Cook : It's due at two o'clock.

Dr Skerritt : It's due at two o'clock—there you are; I've got a news update. That will then go to AstraZeneca for them to respond. There'll be a series of questions. I don't want to pre-empt that advice, because, at this stage, it's confidential. Although, we do publish the committee record when the final regulatory decision's made. In consultation with their international headquarters, the company will come back to us with responses to the questions. I'm hoping they'll do that in about a week, but the ball will be in their court—that's really up to the company. Obviously, our people will look at whether the responses we believe are adequate. At the time of a regulatory decision being made—and this is why transparency is so important—we will publish extensive information, not only for consumers but also for healthcare professionals, on how we made the decision, what we knew, what we don't know, where there's less information and where there are uncertainties. That's all a very important part of a transparency process, as are regular weekly updates on safety records and any other individual information about safety warnings about vaccines, such as, for example, the aged-care deaths in Norway, where subsequently there doesn't seem to be a cause and effect responsibility.

I can come back to safety later because that is a big part of our work in the questioning. To finalise on other vaccines: we have provisionally designated two other products. The companies come to us; they provide evidence that there's a significant breakthrough that is promising early evidence. The Novavax vaccine received its designation a couple of weeks ago, and that's one where the government has procured 51 million doses. The early clinical data from that is promising, but the stage 3 trials are only providing what they call their interim or initial report or readout. It'll be a month or two until they provide what they would see as final clinical data, and we would expect then that the final submission would be made to us. If I were to guess, I would say that we might receive that in April.

CHAIR: Do you think a final decision on AstraZeneca will be made this month?

Dr Skerritt : There are two decisions on AstraZeneca. We're expecting that the decision on the AstraZeneca approval for the global vaccine should be made in mid-February. As I've indicated, by close of business tonight, the company will have the letter; they'll then have to spend the course of next week responding to it. So that would take us on a mid-February trajectory. We won't have the full application on the locally manufactured AstraZeneca vaccine until mid-March, and our staff will turn that around within days. The final vaccine that's been provisionally designated is Janssen or Johnson & Johnson. We are getting some data on that, but clearly there's no agreement for the procurement of that and their intentions as yet are not clear. Of course, Australia has an option on vaccines within the Covax Facility, and that's another 25 million doses. There's a smorgasbord of different vaccines at different stages of development.

CHAIR: I'm not sure whether this is for Professor Skerritt or Professor Murphy. In relation to the vaccine rollout, am I right in saying that people will be prohibited from having two different types of vaccines at least during the initial stages?

Dr Murphy : At the moment, the best clinical advice is that you should have two doses of the same vaccine. As we speak, there's a trial that's starting in the UK looking at whether there is an influence of having a first dose of one and a second dose of the other, and see what sort of protection. But, at the moment, the Pfizer vaccine is registered for two doses of the same vaccine. In the absence of any other data, I would expect the AstraZeneca vaccine will also be registered in that way. In other countries, they've just been given the first dose because they're in such extreme circumstances; we are planning not to give anyone a first dose until we are sure that we have enough doses in reserve to give them the second dose at whatever time frame is recommended by the TGA registration.

CHAIR: In terms of the choice of vaccine dispensed to an individual, how much capacity will an individual have to determine which vaccine they would prefer? Secondly, if you look at the availability of those vaccines and the schedule we have for the rollout, are there particular parts of the Australian community that will be offered the Pfizer vaccine but not AstraZeneca? For example, is there any concern about giving over 65s AstraZeneca, which might mean that they are only offered the Pfizer vaccine?

Dr Murphy : I'll start with that last point first. I think that will obviously depend on the TGA registration decision. I think it's really important to note that there is no evidence of the AstraZeneca vaccine that it is not effective for older people; it's simply that there is a paucity of trial data. There's quite good laboratory data to suggest it produces a good immune response. And the practical experience that we're seeing in the UK, where it's been given to older people, suggests that it is effective and it's preventing transmission, in some preliminary data. I don't want to pre-empt the TGA decision, but if the TGA does register it for all age groups there would probably be a cautionary note that for the over-65s there's more data coming and we'd expect that data in several weeks time. A huge American trial will be published in late March, perhaps early April.

It's very important to note that whilst we have 20 million doses of Pfizer we are dependent on international supply of Pfizer. We're working with them to get a—we've got a good prediction of early supply and we'll get the Pfizer vaccine as the first vaccine we'll get, hopefully later this month, and we will be able to start—hopefully—before the end of this month. Everything is on track to support that. But the biggest supply we will have in these critical first few months is the locally produced AstraZeneca vaccine. The Pfizer vaccine will be rolling out progressively over the year and we will target the Pfizer vaccine, because it's the first one we get, to our highest priority population—that is, quarantine and border workers, and very exposed frontline healthcare workers like ED, emergency and aged care. As we get the AstraZeneca vaccine coming in, we will roll it out more broadly and in a broader range of things. In the main, people will not be given a choice. It will be what is available at their centre, in their profile and their risk group.

I think it's really important to note that, whilst they're in the early phase 3 trials, there was some suggestion that the AstraZeneca wasn't quite as effective at disease prevention as Pfizer. Our view, our gut view, is that the AstraZeneca vaccine is an extremely good vaccine. It was very effective at preventing COVID disease and extremely effective at preventing severe disease, and we're getting more and more data on it. I happen to be over 65 and I'm going to have the AstraZeneca vaccine. It's got a lot of advantages. It's made locally, we'll have plentiful supply and it doesn't have the cold-chain storage difficulties that the Pfizer vaccine has. So we've got two great vaccines. The most important thing we have to do is vaccinate our population as quickly as we can get access to vaccines.

CHAIR: Can I just clarify? Obviously, in the early stages, when Pfizer's the only one onshore, in the first initial weeks it's going to be the Pfizer vaccine that's given to people. But when you have a ramp up of both supplies, apart from locality and whether you can access the Pfizer through those more regulated distribution centres because of the storage conditions and so on, what other criteria would be used to determine whether you were offered a Pfizer vaccine or an AstraZeneca vaccine? Will there be anything in particular?

Dr Murphy : Obviously, this will be an iterative process as we determine supply chain, but each vaccination centre will only distribute one type of vaccine. The Pfizer centres will be run by the states and territories, and Pfizer will also be distributed by the Commonwealth to aged-care facilities through a specific workforce. So we would expect the majority of the Pfizer vaccine, given our current volume projections, to go to aged-care residents and disability-care residents and their staff, frontline healthcare workers, border workers and quarantine workers. Now that we have more Pfizer vaccine, depending on when we get it, we may be able to broaden that access through the state-run Pfizer clinics, but the majority of the general population will be getting AstraZeneca, through GP respiratory clinics, state-run mass vaccination clinics and, eventually, from pharmacies and GP surgeries.

It is a moving feast. Pfizer will give us more advice in the coming weeks about what their supply chain and delivery is, but I would be very strongly of the view that the most important thing is for people, when it's their turn, to get vaccinated. There are two good vaccines, and the most critical thing is for us to get the population vaccinated as soon as possible. I don't know whether Ms Peisley, who's living this issue of distribution, would want to add anything or correct anything I've said?

Ms Peisley : Not at all. Thank you, Professor Murphy, and thank you, Chair. As Professor Murphy's outlined, we are working to ensure that we can have these vaccines in as many locations as we possibly can. Over the last week we have invited a range of healthcare providers to express their interest in being part of the rollout. We've invited general practice to come forward. We've invited pharmacy to come forward, GP respiratory clinics, Aboriginal community controlled health organisations. The idea is that we have information come back from those locations to ensure that we've got equity and coverage across the country for rollout. The worst thing that could happen is that we have an oversupply in one area and not in another, so we need to ensure that we've equity coverage so that people can be accessing the vaccine as soon as it's available to them.

CHAIR: Just one last quick question from me before I move to the deputy chair to follow that up. There was a newspaper report earlier this week about the potential role of nurses in dispensing at GP clinics and other places and concern that there might be delays if people have to see a GP first when nurses have been experienced at distributing vaccines in the past. Is there any consideration of allowing nurses to dispense without necessarily involving a GP?

Dr Murphy : We're working through the model in the general practice clinics. Clearly the nurses will be delivering many of the vaccines. I'm a doctor. I'd prefer a nurse to give me a vaccine!

CHAIR: That's my experience too!

Dr Murphy : This is an environment where—

CHAIR: You wouldn't want Dr Freelander's shaky hands delivering it!

Dr Murphy : This is an environment where we want to have a high level of clinical governance and control over it, so we do want these GP vaccination clinics to be clearly under medical supervision and, if people have questions, to have a doctor there to answer the questions. We're developing that model. Nurse vaccinators are the backbone of our vaccination workforce and they will be used.

CHAIR: I will hand over to Dr Freelander.

Dr FREELANDER: Thanks very much. I'd like to reiterate the chair's comments about all of you and the work that you're doing. I think that Australia's done very well because people are cooperating with what they're supposed to be doing. The major reason for that is that way that you have all communicated what needs to be done, so I think we should all be very grateful to you all for that and so I thank you. I've got a whole range of questions and I hope I don't make you go over ground that you've probably gone over 10 times before—

CHAIR: Of course we'd encourage short answers as well.

Dr Murphy : We're well experienced with your Senate colleagues!

CHAIR: We're far nicer!

Dr FREELANDER: I'm correct in saying aren't I that everyone will be assigned a risk group and the vaccination will then be rolled out according to that risk group? Am I right in saying that?

Dr Murphy : Initially we'll be fairly detailed in our risk group, so phase 1a and phase 1b are very clearly defined risk groups. Once we get into phase 2 we'll largely be using age as the risk because the single biggest risk of severe COVID disease is age. We won't be dividing occupations and things very much after 1a and 1b. Then it'll be by age cap cohorts.

Dr FREELANDER: I'm sure it probably has, but perhaps you could explain, but has consideration been given to how we can get to disadvantaged groups—people who are living on the streets, people in rural and remote communities, people who are from overseas et cetera?

Dr Murphy : On the latter point I think it's important to note that the government has announced the vaccine will be made available free of charge and delivered free to any person in Australia, so that includes people on visas that don't allow them access to Medicare. We are working through the mechanisms of doing that. I think Ms Peisley might comment on the work we're doing. We're doing extensive work with Aboriginal controlled organisations, with cultural and linguistically diverse populations. We have employed a surge workforce of over 500 people to initially go into aged care and disability care but also then to go to areas where there's market failure. Maybe you could provide some more information on that?

Ms Peisley : Yes. We recognise that, whilst we're working with states and territories around implementation in their jurisdiction, there will also be a need to look at some of the specific populations that you've touched on and that Professor Murphy touched on as well. We're giving consideration to what the rollout might look like in Aboriginal and Torres Strait Islander communities and for people for whom English might not be their first language. We are mindful about being able to ensure that we're targeting the message to everyone so that they're aware of when they'll be eligible and when they can receive the vaccine.

Dr FREELANDER: On Christmas Eve, Accenture was described as the data partner. Was there an open tender for that?

Ms Peisley : There was a procurement process. I'm sorry I don't have the complete details about that—

Dr FREELANDER: Could you take that on notice?

Ms Peisley : but I'm certainly happy to take that on notice. We have engaged Accenture to work with the Australian government, as we have with a range of other partners, to help us with our role with respect to the data collection.

Dr Murphy : [Inaudible] the process, and we can provide details on notice.

Dr FREELANDER: Brilliant. I'm just a little concerned about them describing it as a single portal for entry of vaccinations.

Dr Murphy : There's a bit more maturity on that. We do want a single point of community access. There was initially consideration for a single national booking system. We have matured the model somewhat now because some of the states and territories have established booking systems for their clinics. Some of the big GP respiratory clinics and other general practices have booking systems. There will be a single web portal for people to find out when they're eligible and where they might get vaccines. It might direct them to a booking system that's operated by someone else or, in the absence of that, it may offer them an opportunity to book. That's being developed. It won't be rolled out in phase 1a because they're all state-run clinics, targeted people and aged care. There won't be a single point of potential failure, if that's what you're concerned about.

Dr FREELANDER: Yes.

CHAIR: Have there been learnings from the US system in that regard?

Dr Murphy : I think we've learnt a lot from the US and the UK. The most important thing we've learnt is that, given that we've had the luxury of planning time, because we're waiting for our rigorous registration processes to be completed, we can put in so much more logistics planning than they had the opportunity to. They really had to just roll out and 'build the plane as it was flying'. Ms Peisley and her colleagues have been 'building a plane' since before Christmas.

Dr FREELANDER: Thanks for that. I have a couple of logistical questions. Do we have enough syringes?

Dr Murphy : Again, Ms Peisley can answer that.

Ms Peisley : Yes, we do. With the procurement of vaccines themselves, we've also been working to procure a range of what we call consumables. That's essentially syringes, needles and other things that might be needed in the delivery of the vaccination program. The Commonwealth has procured a large supply of those and we'll continue to monitor those supplies.

Dr FREELANDER: Are the vaccine phials multidose phials or single-dose phials?

Ms Peisley : They're multidose phials.

Dr Murphy : This is a significant cause of risk anxiety on our part. We have recently completed a vaccination education program at the Australian College of Nursing. It is running and it's several hours long. Nobody will be allowed to administer a vaccine unless they've completed that course. It is a significant risk because nobody in Australia who gives vaccines at the moment is experienced with multidose phials. We're all experienced with prefilled syringes that come ready to give. In other countries where multidose phials have been used, some of the adverse events from vaccination have occurred due to errors in diluting and storage. That also presents a risk. Once you've opened a phial, you've got to give all the doses, so we want to make sure that any vaccination clinic is equipped to deliver the volume and make sure they use all the stock that they have.

Dr FREELANDER: The Pfizer vaccine is stored at minus 70 degrees. We're not going to be injecting something at minus 70 degrees. Do the logistics include that it has to thaw out on site and then be given?

Dr Murphy : Yes. It's reconstituted, thawed out. Then it has a shelf life whilst it's reconstituted and thawed and it's been tested for stability.

Dr Skerritt : I would just add that it was actually part of the regulatory review process to check both the explanation for how it has to be thawed out onsite and stored post-thawing, and the scientific data—that it didn't just break down immediately after being thawed—was robust and rigorous. Part of the TGA's review was much broader than the clinical aspect; it was also looking at the logistics of thawing and the data that actually supported how long it could be stored once thawed.

Dr FREELANDER: I have one last question for this round. Professor Skerritt, there has been a lot of talk about treatments other than immunisation—

CHAIR: Really!

Dr FREELANDER: has there been any approval for the use of hydroxychloroquine or ivermectin for the treatment of COVID-19?

Dr Skerritt : None of the comparable OECD regulators have provided regulatory approval for hydroxychloroquine or ivermectin as treatments. There are still some trials going on for both drugs. There were a number of early trials, but more rigorous, controlled, randomised-controlled trials undertaken in the top medical centres didn't, unfortunately, support some of the early optimism. That's why at the moment, the national evidence taskforce does not recommend the use of hydroxychloroquine. The evidence is not there for ivermectin. There's some evidence in vitro, but the actual concentrations that you might use in a test tube in a laboratory were actually a fair bit higher. There is research going on globally. I think you've raised an important point that, if we look at the management of viruses, some viruses such as HIV/AIDS and hep C have actually required a therapeutics approach rather than a vaccine approach. I do believe therapeutics will have an important role in COVID, especially if it becomes endemic, and they will complement the use of vaccines for prevention. The development of therapeutics has been slower than we would have liked although, in this country, we approved Remdesivir on label and also the steroids used off label—dexamethasone and others.

Dr FREELANDER: Great. Thank you very much.

CHAIR: I want to follow up the question that Dr Freelander's asked about the distribution. Have you looked at wastage rates from the distribution of vaccines? How will you manage that? Have you got any projections as to what the wastage rates might be?

Dr Murphy : We are very focussed on this as an issue because these resources, particularly, are really precious. Again, Ms Peisley's team is setting a range of parameters and KPIs. We're going to have very, very good data systems, much better than we have for our ordinary, national immunisation programs. We want to be able to track every phial and every dose and make sure that we have real-time reports on wastage. Frankly, if a clinic has an unacceptable wastage rate, they may no longer be a clinic. It's a really important issue for us. Ms Peisley, do you want to comment further?

Ms Peisley : This goes to Professor Murphy's point earlier about training and why that's so crucial, because, in this country, we don't have many multidose phial presentations—certainly, this will be the first in quite some time. So it's important that we train people in the use of multidose phials so they can extract every single dose from the phial and make sure that an effective dose is given to each person. We do have a range of training programs in place, in particular relating to not only multidose phials, but also the slightly different presentations of each of the vaccines we've got. You alluded to the Pfizer vaccine—it has different cold storage requirements that are distinct from the AstraZeneca vaccine. So that's why training is so important. It's why data systems are so important so that we can track and trace every dose.

Dr FREELANDER: Sorry, could I just ask an additional question? How many doses per phial?

Ms Peisley : I understand the Pfizer vaccine has six doses per phial.

Dr Skerritt : It might be valuable for the community to hear from Dr Pegg about the work that was done literally over the last couple of days on the Pfizer approval, to be able to get that additional dose approved.

Dr Pegg : The original Pfizer application was for five doses per phial, which was the same product that was rolled out around the world. Subsequent to that, large jurisdictions like the United States and Europe made some variations to those authorisations to enable a sixth dose, because it's common in manufacturing procedures to overfill phials. But, in Australia, to make such a change, we require certain information from the company as part of our robust process. So towards the end, actually, of the evaluation process we were given that information, and we're able to ensure that six doses per phial was the approved product for Australia, which is obviously crucial for that extra dose.

Dr MARTIN: I want to express my gratitude also for your commitment and service during this incredibly difficult time. I'm sure you've been working above and beyond what would normally be expected of you. So thank you. My questions are in relation to uptake and, if uptake is lower than expected, what strategies are going to be put in place. In particular, my question is about the line of thinking—and I did ask this when we met the other day—around the transparency of information, the openness around the risks. The immunisation schedule for children up to four years is not necessarily consistent between states and territories; there are slight variations. We don't have the same strategy in place, in the sense that we don't share as much information, or it's not as accessible to parents. It's fairly basic information for your average mum and dad, who are encouraged to complete the blue book for their child. I'm wondering about the psychology around that and if there is data that suggests that having such transparency and information about associated risks will actually increase uptake of the vaccine. That's one question.

My other question is in relation to the Pfizer vaccine being given at least 21 days apart. Is there a critical window? What is the latest possible date for the vaccine to be still effective? What if we don't have compliance for the second dosage? What if people don't come back for the second dosage? What strategies are going to be put in place to ensure that we do have follow-up for the second dosage?

Dr Murphy : Those are really good questions. We love psychology. We are spending well over $23 million, I think, on a comms campaign, which is in three phases. The first phase is to get people confident about the registration process. They feature gentlemen in white coats and other people to assure people that our registration processes are as rigorous as anywhere in the world. Then there will be other phases that will deal with all of those issues. We've taken the approach with our previous immunisation campaigns which we have run in the past—Ms Peisley was very involved in those—that, as you said, the best way to get to people is not to badger them; it's to give them the facts and to be absolutely transparent. That's why the TGA puts everything on its website. So it's put a statement on its website about the Norwegian aged-care associated deaths. We will be publishing all of the data that we get if there are reported adverse events, and, in this communications campaign, we will be having social media, television, internet, and access to information, and we'll continually update that as we go. I might get Ms Peisley to add further, and the TGA to comment on the 21-day issue. I think the issue is that, if you've gone longer than 20 days, it's almost certainly very beneficial to have your second dose. And we would not stop someone having it, even if it were two or three months later. But the way we're structuring our program and the incentives we have built into it is that it'll be in the interests of the clinic that gives you the first dose to contact you and bring you back for the second dose. Certainly in the general practices, they get an extra bonus if they bring people back for the second dose. And that's been a deliberate strategy.

CHAIR: Just to clarify, there's no plan to go down the UK path of deliberately delaying the second dose, is there?

Dr Murphy : No, but we don't have a registration decision on the interval between the AstraZeneca doses yet.

CHAIR: But there's no plan for Pfizer or—

Dr Skerritt : For the broader community, having their vaccinations at a GP—individuals have a special relationship with their GP. I know if my GP says: 'Hey, John, I need you to come in; I need to talk to you,' I tend to jump. Some groups are part of a so-called active surveillance campaign, which is part of the safety monitoring. It will check whether individuals have had immediate reactions after vaccination, or perhaps longer-term reactions. But, frankly, one of the most valuable parts of the active surveillance campaign is actually the reminder factor, to remind individuals to go back and have their second shot.

Ms Peisley : That's why the passage of legislation that we saw yesterday about mandating reporting to the Australian Immunisation Register will be so incredibly important. It's a critical platform to facilitate the recall of people for their second dose within the time frame that's required. It will then be something that, as Dr Skerritt talked about, gives practitioners an opportunity to recall their patients, based on the register information. Going to Dr Murphy's point around communications, the Australian government has taken a view across other immunisation programs—and this one is certainly no exception—that we provide evidence based advice to allow people to review the evidence for themselves. We provide it in a range of formats.

Dr MARTIN: That's the question I have about informed consent. For the average Australian who can't interpret research, because they don't necessarily have the research skills to be able to, are we relying on our GPs to translate that information?

Ms Peisley : Information will be provided in a range of formats. It's incredibly important, as you say, to provide information to health professionals so they are able to have that conversation with their routine patients or other people that might be considering vaccination. It's also important to provide information to parents and carers who might be considering vaccination for themselves or for others that are within their care. So it's important that the communications activities that we have underway provide information to a range of different audiences and in a range of different languages. We heard yesterday that the materials will be translated into over 63 different languages, and we know that's a really critical thing for people for whom English is not their first language.

Dr MARTIN: That's very important for my seat, Reid. I was very happy to hear that.

CHAIR: We know that, in this day and age, it's possible for rumours and theories to run riot very quickly through social media and other platforms. You only have to watch one of your press conferences and see the comments on Facebook to see that happening. Do you have some sort of ready response team monitoring whether a particular theory which might be detrimental to the vaccination program is taking hold?

Ms Peisley : Our communications team does that, and we do other things which monitor sentiment. That's why we have communication plans in place. We also need those plans to be flexible enough to pivot to whatever the issue of the day is and whatever it might be that we need to respond to in terms of the sentiment we see coming forward, so we can continue to provide that evidence based advice based on the information that we see coming forward.

CHAIR: Thank you.

Dr Skerritt : We are also part of a global network of regulators. If some conspiracy theory comes out of the US—of course, there have never been any conspiracy theories from the US, but if by some rare hope one came out—we get flagged through the international group of regulators, and that gives us a chance to start to think how we might address those issues if they land in Australia.

CHAIR: Yes, home of the brave and the conspiracy. Ms McBride.

Ms McBRIDE: I echo the comments of others in thanking the team that we have and the work that they're doing on behalf of all Australians. I have a question about the hubs that have been announced—in my state of New South Wales, for instance—and what the outreach will be, particularly in phase 1. In the community that I represent, one in five people are aged over 65 and the second biggest employer is the health sector. I'm really keen to know what the logistics are or what plans are in place for outreach, firstly to frontline workers but also to people in aged care and disability care. Hornsby and Newcastle have been announced as hospital hubs, but none on the Central Coast have been announced to date.

Dr Murphy : The first hubs are very limited. There will be more hubs coming out later, but, initially, we don't want to open more hubs than we have vaccines. We've done those initial hubs in partnership with the states and territories. Those initial hubs will be very focused on a highly select group—so the quarantine and border workers and some of the most exposed frontline healthcare workers. By the time we get to phase 1B there'll be other state run centres and some other Commonwealth centres open, and other healthcare workers will have access to vaccines from there. In terms of aged and disability care, we are going into those facilities. We've procured a workforce of over 500. We will be going in in in-reach teams and offering vaccines to aged-care and disability care workers. In some states and territories where they have public sector aged care they have chosen to do that themselves, but we will be providing that as an in-reach service for the great majority of aged-care and disability care facilities.

Ms Peisley : Those hubs will be available in, as we've indicated, a number of limited locations initially and then potentially more locations over time. It's important that those hubs will be used as locations to draw vaccine from—to use for in-reach workforces, as you've described, for aged and disability care both for our residents and workers in those locations. So, whilst there might not necessarily be a Pfizer hub in every location, there will be opportunities to use those hubs to draw vaccine from, using our distribution partners to facilitate that.

Ms McBRIDE: May I just ask a follow-up question. If you're a frontline health worker and you're in a community like mine, where the hubs are an hour away, what how would that work? Would there be in-reach? What are the logistics for that sort of scenario?

Dr Murphy : In phase 1A we're only talking about a very select group of frontline healthcare workers—emergency department, intensive care, people working in COVID wards. NSW Health will be planning how those hubs will be used to vaccinate the small number of those workers who are not close to a hub. I think that that planning is underway.

Ms Peisley : It is. We continue to work with the states and territories on what that looks like in each of their locations; for instance, the delivery in New South Wales will look very different to the delivery in the Northern Territory. There may be other issues that need to be overcome in terms of distance and storage requirements. So we continue to work with each jurisdiction through the nuances particular to their state and territory delivery, knowing that we've got a national program to work from.

Dr Murphy : It's critically important. In the first few weeks, in the first hubs, the most important thing they will be doing is vaccinating the hotel quarantine workers and the border workers, because that is our highest risk point at the moment.

Dr FREELANDER: Can I follow-up: they will be getting the Pfizer—

Dr Murphy : Because it's the first one we have.

Dr FREELANDER: So the Pfizer vaccine will not be delivered by GPs?

Dr Murphy : The Pfizer vaccine will not be delivered by GPs, no.

Dr FREELANDER: Thank you.

Dr ALLEN: For the record, there are three aims of the vaccine: prevent severe disease, prevent any disease and prevent transmission. There's been a lot of media commentary, particularly journalists, talking about the comparison between Pfizer and AstraZeneca with regard to preventing any disease. For the record, could one of you please indicate to us what the comparator is between AstraZeneca and Pfizer for preventing serious disease?

Dr Murphy : The data we have—it is fairly limited; I'll get Professor Skerritt to follow up—is that both were very effective at preventing disease and extremely effective at preventing severe disease. Numbers in the trials were small, but we are very confident that they will both be effective at preventing the sort of serious disease that will end up in hospitalisation. Whilst the initial data on all the vaccines is relatively limited, the data we're getting out of the UK now is suggesting that both vaccines are indeed effective at preventing severe disease. There's some interesting data in that the AstraZeneca vaccine seems to be effective at preventing asymptomatic transmission. That's not published yet—it's preprint data—but that is quite exciting.

We really have no good data on the efficacy of preventing transmission of either of the vaccines. It is highly speculative and too early to talk about whether one or the other would be better at getting herd immunity. Our aim at the moment, as you said, is absolutely to protect our population against getting clinically severe disease. That's the aim at the moment. Herd immunity remains a longer-term goal for us and for the rest of the world. Professor Skerritt, would you like to add anything?

Dr Skerritt : I think you've answered it. Even the World Health Organization has stated that it's unlikely that any major economy will have herd immunity during 2021. The response is not dependent on herd immunity. It's an objective to have but protection against severe disease will help us to resume our normal activities and daily lives in a COVID-safe way. Again, efficacy numbers can be overplayed. These are data from different arms of a clinical trial. As Professor Murphy said, it's only part of the overall picture; the most important thing is actually the number of people who get vaccinated.

Then the other things that affect the quality of the vaccine response—whether it leads to herd immunity or not—are, of course, things such as the duration of immune protection, which we don't know. So far, from antibody and other tests, it's suggesting that some of these are lasting the full eight months or more, but we don't know whether that's one year, five years or forever. Then, of course, there are issues of variance and protection against variance. There are also issues relating to the range of protection against transmission, ranging from asymptomatic through to transmission of people who have clinically-obvious disease. I think it's a little bit like football scores; the focus of the media on numbers has actually not been all that productive.

Dr ALLEN: Just to clarify: as public health experts of course you're interested in transmission because of the impact on the ability to have discussions and make decisions about lifting restrictions and allowing Australians to go back to normal life. The ability to prevent disease is important from a public health point of view, but for Joe Blow, sitting and working out which vaccine he may or may not get to prevent him—for all intents and purposes—from dying from COVID or getting a serious disease that might result in his death, does it matter which vaccine he gets?

Dr Skerritt : Precisely. The message is that if you get vaccinated your chances of not getting very ill and ending up in hospital or worse, especially if you're older than 60, 70 or 80—because we know that morbidity and mortality dramatically increases above 60, and even further above 70 and 80—is significantly reduced. The message for younger and fitter people—those in their 20s who may only very rarely get sick—is to get vaccinated because the promising early data on transmission shows that vaccination might help protect your grandmother, great aunt or someone who's immunocompromised and is unable to take the vaccine. You're doing it for the community.

Dr ALLEN: I'll take that question a further step: I think Australians have been very pleased with the public health response led by your team, Professor Brendan Murphy, with regard to aggressively supressing the virus so that we've had time to more formally assess these vaccines and also to get our ducks in a row to roll them out. For those who might say: 'Why not wait longer? Why rush into this?' what would you say to them, knowing the information we have with regard to the pandemic raging overseas and knowing that we have measures in place that are containing it here? What would you say to them about what the impact on Australia would be and on its ability to interact with the rest of the world if we did not roll out the vaccine for, say, one year?

Dr Murphy : I think that would be a very, very foolish thing to do because, whilst we are in a good position, whilst the rest of the world is full of COVID it's a precarious position. We are committed to bringing Australians home. We have to bring people, freight and vital equipment into the country. As we've seen, while hotel quarantine has been incredibly effective, one per cent of the people coming back into this country develop COVID. No system is absolutely perfect and we are always at risk of other waves. We manage them very well. We've seen just recently with small breaches of hotel quarantine that the risk appetite in the states and territories is such that very extreme measures are often taken for short periods of time. They are very disruptive, and we want to get to a position where, if the population is vaccinated, we might get small outbreaks and we might not be so worried. We might be able to contain them without having to do such extreme measures, and then, progressively, as we get more and more people vaccinated and more evidence on transmission, we may be much more relaxed about opening borders and stopping hotel quarantine. So, progressively, as the data emerges and the population is vaccinated, we will be on a path to relax these measures. The nirvana is clearly returning to full international travel. I keep getting asked 'When?' and I say—

CHAIR: 'It's on my list!'

Dr Skerritt : And I say, 'We don't know.' But, progressively, it's likely that we'll be able to relax our public health response measures over the second half of this year, including measures relating to travel. There is so much still to be known about the efficacy of the vaccines, but it would be a very, very foolish thing to not be vaccinated now, because we are in the position of knowing that these people are the best regulators in the world. I am absolutely confident to roll up my sleeve and get one of the vaccines. I'll be getting the AstraZeneca vaccine, and I think that it would be a very foolish thing to not have confidence in what we've done. We've done the full regulatory process. They're good vaccines; both of them are good. We want to get our population vaccinated and protected and start this journey to a normal life again.

CHAIR: I might ask a follow-up to that on a slightly different angle. There are some that have said, 'Why don't we wait longer just to see if there are any other unforeseen consequences that we don't know about?' When the vaccine has been in the process of being rolled out now for months and months overseas, is there any evidence that waiting would see the exposure of problems that aren't already known?

Dr Skerritt : As I indicated earlier, most rare but serious adverse events, which we call adverse events of special interest; there's always a euphemism, such as neurological conditions or Guillain-Barre and other syndromes or rare diseases of a cardiac or nervous system—the history across all sorts of vaccines is that most of those appear four, six or, at most, eight weeks after a population is exposed to a vaccine or after medical trials. I might suggest Dr Cook, who's actually a medicine safety specialist, to enlarge on the history of when we've picked up serious adverse events and the time frames.

Dr Cook : Most of those neurological events of concerns—Guillain-Barre is one of the common concerns and transverse myelitis is another—usually occur four to eight weeks later. Obviously they occur in the population anyway because they are associated with a whole range of idiopathic or infections or other conditions. Often the difficulty is determining whether it's vaccine related or something that coincidentally occurred for that person at that time. There's been no evidence where it's been rolled out in the US or the UK to date that there's been any increase in those. Because they are the sorts of things that we are interested in, the regulators there are monitoring that through their adverse events systems as well as probably looking at linked data to see if there are increases in hospitals and that sort of thing.

CHAIR: In short, if major problems were expected to arise, we would have seen that by now?

Dr Cook : I would have expected to have seen something reported to date if that had occurred. People would be looking for it. If you're a person in a hospital, you would be looking—'I'm seeing more cases of GBS or more cases of this. Did the person have the vaccine? I'm going to report it.' There's sort of a hypervigilance in a way looking for those things, and we haven't had any evidence that those are being picked up. Here we will certainly ensure that we are looking for that. We'll be encouraging doctors to specifically look for it and patients to report when they get unusual things. The difficulty, obviously, of the system is the time lag. It's very easy to say, 'I've got a sore arm and I had my vaccine yesterday.' It's more difficult to work out: 'I've got this thing now. Could it be the vaccine?' I suppose it's reinforcing with our healthcare professionals and the public to just be vigilant and to report.

CHAIR: So the barmy army have been very good canaries in the coal mine for us!

Dr ALLEN: Just to sort of finalise that part of my questioning, would it be fair to say that the primary goal, whether you're young or old, is to protect yourself and the community against serious disease because then we can get back to work quicker?

Dr Murphy : That's the primary goal at the moment. The subgoal is that we think it'll help significantly prevent transmission, and that's worth doing too.

Dr ALLEN: But if this were not something that killed people, is it likely we would have would have shutdowns or lockdowns that we are having?

Dr Murphy : No, I think the public health response would be much less risk averse.

Dr FREELANDER: Am I right in saying that until we start immunising children, we're not going to get herd immunity no matter what?

Dr Murphy : There are lots of models around that. It depends on the efficacy of the vaccines at preventing transmission. But it's quite possible that to get that proper definition of herd immunity, you may need to vaccinate children. Children, we know, don't get the disease very often. Some of them do get it—particularly teenagers seem to be able to transmit it. Little children seem to not get it very commonly. But it's quite likely that, for the world to get full herd immunity, you may need to have children vaccinated. Again, none of the vaccines are registered for children at the moment, but that might change.

Dr ALLEN: But the difference between a condition that is a flu-like condition and one that's going to kill you is quite dramatic, and the impact it has on our restrictive behaviours is quite dramatic. But also isn't it true that the reservoir for COVID is between 20 and 30 year olds?

Dr Murphy : Yes.

Dr ALLEN: So getting vaccine uptake in that group of people, which is different from the flu—

Dr Murphy : The young adults are the spreaders, absolutely.

Dr Skerritt : And emphasising the benefits to that group. Unfortunately, as you get into the 30-year-olds, the studies show that more vaccine hesitants, anti-vaxxers and vaccine doubters tend to be in the late 20s and 30s cohort. So that's why the messages need to be targeted towards those groups. Even though they may not get all that sick, we've got to think of their community responsibilities not only in their own family but more broadly.

Dr ALLEN: I have some technical questions, but I'll wait for the next round of questions.

Ms BELL: Thank you, everyone, for being here today and for your collective service to the nation. Australians are very grateful. Obviously, while keeping Australians safe from a health point of view is the primary goal, Professor Murphy, you touched on the nirvana of getting back to normal when it comes to freedom of movement. Could I ask you to expand on what you think might happen, firstly, domestically with border closures and COVID hotspots and, secondly, with international movement between countries and what that might look like. I won't ask you for a time line.

Dr Murphy : Thank you. I would hope that state border closures will be a thing of the past soon. Once we have the vast majority of the vulnerable population vaccinated, I would hope that the state and territory health officials would feel sufficiently relaxed to be able to tolerate small outbreaks. They have all shown that they're really good now at contact tracing and controlling outbreaks. Hopefully we'll see very much, much less of that early in the vaccination course. The other thing is that once we've vaccinated the quarantine workers and the border workers, if, as we expect, the vaccines have an effect on transmission, we'll be much less likely to see these quarantine breach single cases or small outbreaks. My hope is that in coming weeks we might get to free and stable transport across the country and access across the country.

As for international borders, I just find it hard to—I've been caught out before by making predictions, but I think we just don't know. What I've said on a number of occasions is that I think with international borders, there certainly wouldn't be any change likely in the next three months or until the middle of the year. I think from the from the second half of this year, as we get more and more data on the vaccines, as we see what's happening in other countries, as we see how well our population is protected, we would probably start to take the health advice from AHPPC and look at whether we can make that the border restrictions less onerous, whether we can open up more green zones, whether we can make a move, perhaps, to home isolation from some countries and then eventually move, over the course of this year, to progressively relaxing restrictions. I think the very famous Dr Fauci said the other day—he seems a very happy man—

CHAIR: Happy since 20 January, for some reason!

Dr Murphy : that he thought early next year would be when the US would be back to free and normal international travel. I don't want to make a prediction, but I think progressively over the second half of this year we should see a trajectory towards normality—my best guess.

Ms BELL: Further to that, how do you think, specifically, it will impact on social distancing? You mentioned earlier that social distancing will remain. That has an impact on mass gatherings, outdoor gatherings, events, those sorts of things. Do you think that once we have the population vaccinated they will be able to resume?

Dr Murphy : Absolutely. I think there'll, again, be progressive staged relaxation in those measures. The last things to go will probably be QR codes and tracking people and it may take us a while before we shake hands again. I would imagine, when we've got a well-vaccinated population, particularly the vulnerable people, I can't see why we wouldn't be looking at returning crowds to events and stadiums and the like. The success of Australia's COVID response is because all of our governments have taken the health advice, at every stage, and they will continue to do that as the pandemic evolves, as vaccination evolves. All of our governments are very keen to relax things, and once the health experts at AHPPC agree to that they will do it. But I think that will happen.

Mr ZAPPIA: Thank you very much to each of you for all of the work you're doing; I think it's fantastic. I do have several questions but I'll ask two or three very brief ones. Firstly, where is the Pfizer vaccine that we will be getting manufactured and when will the stocks first arrive? Secondly, will the vaccine be effective on all of the different strains that have so far been identified? Thirdly, and I think you've answered this but I just want clarification, once a person is vaccinated are they still likely to be a carrier and a transmitter?

Dr Skerritt : To answer your last question first, because we've had a lot of discussion about that recently, the ideal is that not only would the vaccines reduce serious or even less serious illness but they'd also hinder transmission. There's a little bit of preliminary evidence emerging in the scientific literature, but there seems to be an impact on transmission. But it'll be a couple more months until the evidence is firm enough to be able to make statements about transmission.

Onto your issues, specifically, about the Pfizer vaccine, the Australian source of Pfizer vaccines being manufactured in Belgium—that's where it comes from—it's actually a complex manufacture. Like so many modern medicines and vaccines, things are not made in one place at one city. There's one step where copies of a DNA are made. It's an RNA vaccine, which is basically a photocopy of the DNA in what they call transcription, to make messenger. Then it's put inside little balls of lipid, of fat; otherwise, it would break down before it would be vaccinated. That's all done in different places, globally. Some of that technology comes from the US. This is why the discussions right across the global supply chain are important.

We are expecting this vaccine to land in the country in the next couple of weeks. We don't have a date that the plane is leaving yet, but there's nothing to give us the view that we won't be having the vaccine arriving in the country this month and people being vaccinated.

Dr Murphy : Our target is to vaccinate people before the end of this month.

Mr ZAPPIA: Have there been any concerns raised, in respect to pregnancy and the use of the vaccine?

Dr Skerritt : Again, it's more a lack of data rather than any evidence of miscarriages and the like. Different groups are adopting different approaches. In the information to doctors, which we call the product information, we're having to say that there wasn't evidence for the use of this vaccine in pregnancy. Some clinical groups are recommending that, if you're not in a high-risk or high-exposure group and if you're pregnant, you hold off until you have the kid. However, there are the examples of the US and the UK, where you've got a number of pregnant healthcare workers and both systems are under such strain. If you took every pregnant doctor and nurse out of the UK at the moment and told them to stay at home for nine months, you'd put the system even under more stress. So in those countries it's an individual informed consent decision, but, after having a discussion with their vaccinator, they're keeping registries to monitor how well those folks are going following vaccination. There hasn't been any evidence—and I'll check with Dr Cook that my statement is correct—of ill effects in pregnancy. It was more that, in clinical trials, it's normal to exclude pregnant people.

Dr Cook : Yes, that's correct. They're excluded. Although there would have been some who would have become pregnant, they would have been monitored. As far as I'm aware, there's been no evidence of any harm. But I suppose it's a precautionary principle, and then it's a decision for the clinician and the patient based on their risk.

Dr Cook : Let me add that there hasn't been any evidence in the number of studies either, which is also part of the usual clinical development. So that's good.

CHAIR: I was going to ask this before: is it fair to say that this vaccine rollout will be the largest public health undertaking that's ever happened in Australia?

Dr Murphy : I think it's probably the largest logistical public health challenge. We have a huge team of people focusing on this—lots of industry partners and a very complex partnership with the states, territories and health professionals. It is absolutely huge. I think it's properly worth saying that, despite all of our wonderful planning and systems, there will be hiccups. We should expect them, but we've got all sorts of mitigations and really good governance structures around it. But it is huge, yes.

CHAIR: To give us a feel for it, when it ramps up to its full peak, how many people are we talking about being vaccinated a day—tens of thousands?

Ms Peisley : It really depends. Certainly we're planning for all contingencies, and we've talked about estimates that we'd like to reach at different points along the way. Those estimates and the forecasting are based on dose availability and registration, but we're planning for each and every scenario and making sure that we've got vaccines available to meet the needs of the people who'd like to come forward at the time.

CHAIR: Do you model the capacity so you can say that the system can actually cope with vaccinating X number per day if there are that many vaccines available?

Ms Peisley : We model a range of scenarios in terms of making sure that we've got doses getting into each and every location that we've got available to us. We need to have in place those systems and processes to be able to track and trace doses, because we will need to make sure that people can make appointments and that clinics can be planned around those people coming forward. We touched on earlier the use of multidose phials. We've got very low tolerance for wastage, so we need to align people coming forward with the dose availability to make sure that we are—

CHAIR: I'm not trying to pin you to a number, but, if everything is going well, what is the type of capacity you think Australia will have at its peak for daily doses?

Ms Peisley : I think we've talked about some of the doses as being four million across the period, and certainly we've indicated that by October we hope to be able to reach everyone who'd like to come forward for a vaccine.

Dr Murphy : Initially, when we had more certainty over the international suppliers, we had a target of close to four million by the end of March. As the Prime Minister said, that's likely to be more into middle April now because of the restrictions in supply of international doses. The single most important thing that I think we've done is have onshore production of a vaccine. So once that—

CHAIR: That's still quite extraordinary, because four million is basically a million a week.

Dr Murphy : It could be at that level, but I think we're very wary about making predictions. That's the sort of level that they presume they can potentially deliver at. As Ms Peisley said, we will scale up the sites of vaccinations according to what we've got. We'll have plans, and we'll just bring centres online—we do not want to have a centre that doesn't have enough vaccines to do a good day's vaccinations. So we'll scale it up. We're very wary about quoting exact numbers, but I think it's reasonable to say that our aspirational target is into April—by the middle of April we hope to try and get to four million. But we don't want to be held to that, because we want to make sure that we do everything safely and properly and carefully.

CHAIR: We now have been able to see the rollout in some other countries. In some places it's been shambolic. In other places—Israel seems to be the world leader at this stage. Is there anything that you've observed from overseas which has led you to change what we're planning to do in Australia, or that you've found educative as to what to do better or what not to do?

Dr Murphy : Israel's a very interesting case study, because it's a very small geographic area—

CHAIR: I wasn't just referring to Israel.

Dr Murphy : with a high population and a very well-distributed health system, so they had a lot of the structures and systems in place. And it's not a federation, obviously; it's one country. I think that the demography of Israel is well suited to a rapid rollout. One of the things that we have learnt from the UK and the US is, particularly, to do that logistics planning before you start—to try and ship before you've thought that through and done all of the time lines and the various charts of where things can go and what and what could go wrong, to get the data systems in place early. I don't know whether you would like to comment, Ms Peisley.

Ms Peisley : We do continue to watch it overseas. We're in a very fortunate position here that we can learn from different locations. That's been enormously helpful for us. I think the planning and logistical exercise, whilst we rely very heavily on our colleagues from a regulatory perspective, we then need to translate that into a logistical exercise. So, having the luxury of time, I guess, to be able to make those plans, to work with our state and territory colleagues, and to make sure that we can take an approach where we target those first priority groups and first doses around looking at the areas in which people are at greater risk of severe disease or coming into contact with severe disease. I think taking a different view about making sure that we only have one vaccine in one location is also something that will be crucial. Looking at being able to train the workforce that we've got to be able to deliver the program, as well, has been something that we've been able to look at from other countries.

CHAIR: Dr Freelander, I might just quickly give you the chair.

ACTING CHAIR ( Dr Freelander ): If you've had COVID-19, should you be immunised?

Dr Murphy : I think the answer is that it's probably safe to be immunised. There's no evidence—you haven't put it in as a contraindication?

Dr Skerritt : Correct me if I'm wrong, Grant or Jane, but there was no contraindication in the regulatory decision?

Dr Cook : Some of the clinical trials had rather large percentages of people who already had COVID.

ACTING CHAIR: So the answer is probably yes.

Dr Cook : Yes.

Dr Pegg : That's certainly become an increasing feature of future trials, because, of course, there are going to be more people who are seropositive or have had COVID-19 previously. There's no there's been no requirement in the clinical studies or, indeed, for the approved vaccine to have a COVID test.

ACTING CHAIR: It's often been said that the best immunisation for COVID-19 is not around as yet, but are we actively looking at other vaccines, like the Janssen one that's a single dose? I've heard the Sputnik Russian one's supposed to be good.

Dr Skerritt : We're actively looking at two things. There's a committee which Brendan chairs and we are observers on. It's got some of the best vaccine and immunology people in the country, who advise the government on procurement. That's the so-called SITAG committee. Separately, but related to that, there are companies and researchers and company-research partnerships. We've made it quite clear that the TGA is very willing and quite interested—more than quite interested—to engage with them as early as possible and to talk with them. I think we've talked to about another dozen on top of the household-name companies. Some of these, in a couple of cases, haven't even got the first vaccination into a human being. In other cases, they're not far behind companies like Novavax and Janssen. There are a range of second-, third- and fourth-generation technologies. The most well-known is Janssen, who are promoting a vaccine based on a single vaccination. There are a couple of other companies looking at nasal vaccines for people who are needle shy. Although their current trials weren't all that good as far as efficacy, there's even a company looking at an oral vaccine that you can swallow. There are different technologies. There are DNA based vaccines and, of course, there are other technologies looking at room temperature-stable or refrigerator-stable vaccines. There are also vaccines that are provided in a dried form but are just reconstituted on the spot.

One of the signals that there is a view that second-, third- and fourth-generation vaccines—and, of course, the other cluster of second-generation vaccines will be ones against variants, but I'll put them to one side—is a sheer investment by pharma and researchers in this. Most of the pharma companies have major multi-hundred-million dollar plus research and development, and translation programmes. When I really want to upset my colleagues, I say, 'Yes, we're doing no. 2 at the moment, and we've probably got another seven, eight, nine, 10 of these to do in the next two years.' The basis on which those vaccines will be available—there'll only be a limited number selected for Commonwealth procurement—is something for the future to unravel. But I expect we will have several vaccines going through our system in the next 18 to 24 months.

Dr FREELANDER: Dr Murphy, we've committed to helping our Pacific neighbours. When are we going to start rolling out vaccines to them, and will it predominantly be the AstraZeneca?

Dr Murphy : Obviously, AstraZeneca and then, later, Novavax, are the likely ones. DFAT have invested over half a billion dollars in a vaccine for the Pacific and they're doing some advance planning with the Pacific countries at the moment. Obviously, our priority is to start our local vaccination first, but, once we've got spare supplies—I don't know whether John would like to take this.

Dr Skerritt : I might. I actually come from a development background, so it's a personal as well as a professional interest. I was the deputy head of part of Australia's overseas aid program for 10 years, in a previous life. The department, through the TGA, is heavily involved. Our first priority—and I've said this to DFAT, and they get it—is the Australian rollout. We're also heavily involved—in fact, we're recruiting 17 positions at the moment—in supporting technical advice to both South-East Asia and the Pacific in the rollout and selection of vaccines, the regulatory issues and helping those countries develop safety systems. A country like Tonga essentially doesn't have a formalised medicine vaccine safety system. That's going to be really important for confidence. If you have two women in a village who miscarry two days after having the vaccine, you could lose whole villages and potentially half a country out of a vaccination system. We saw that in Samoa with the measles vaccine recently. In South-East Asia, the nature of our assistance will be different. They don't need us to build a vaccine safety system for them, but, for example, the Indonesians have never seen a messenger RNA vaccine before, and they want high-level technical, scientific help with those vaccines. We have a $10 million plus program, which builds on another $15 million program, working with about 20 countries to provide that technical backup.

As far as what vaccines, there are really two or three broad ways countries can access vaccines; I'm talking about countries in the region. Firstly, Australian-approved vaccines—and it may well be that, later in the year, there will be sufficient supplies so that some of the CSL manufactured AstraZeneca can go offshore as a donation to those countries. The second thing is that the government, through DFAT, is also funding procurement that will essentially cover the full population of East Timor, Papua New Guinea and all the Pacific islands, and will cover a percentage of the population—and that percentage is a lower percentage targeted at vulnerable groups—in countries like Indonesia, Vietnam, Cambodia, Laos, Myanmar, we hope, and the Philippines. That's the procurement side. And that isn't just the Australian vaccines. One of our roles is technical help. Let's say one of those countries does want to get Sputnik and, for whatever reason, Indonesia gets a really good deal on Sputnik. They can come to us for technical help, even though Australia may not get Sputnik, in what they have to look at in reviewing the quality and performance of a Sputnik vaccine.

Dr FREELANDER: And then we'll fund a percentage of—

Dr Skerritt : What vaccines the country buys are in accordance with the principles of what's known as the Paris Declaration, which is self-determination. Australia will not jump in and say, 'You must not buy that vaccine.' We will give our technical advice saying, 'Hey, we've got worries with that' or 'That looks pretty good,' and we'll offer to help in their review. But the countries will be able to make sovereign decisions.

Dr Murphy : It's probably worth mentioning the COVAX.

Dr Skerritt : Finally, the third route—thanks, Brendan—of access to these vaccines offshore is what's known as a COVAX facility. That's a facility, firstly, through which Australia can purchase. It's an option to purchase that developed countries like Australia have, and we can purchase up to 25 million doses. But it's different for other countries in the region, depending on their development status; so the poorest countries will get access to a certain number of those vaccines 'for free'. Again, why we're having to hire 17 extra people is that some of those COVAX vaccines may not ever come to Australia. The Moderna vaccine may or may not come to Australia, but it may well be that Vietnam or the Philippines wants to procure that one. Again, we'll work with the Philippines's regulatory equivalent of us in reviewing the Moderna vaccine.

Dr Murphy : We've invested in COVAX, in their development arm, as well. We made a very substantial investment in supporting the Pacific.

CHAIR: I'm conscious of time; technically, we've only got four minutes left, so we might have one very quick question each.

Dr MARTIN: We talked about pregnancy before. Is there any data for any of the vaccines at this point about potential side effects for people with chronic conditions. In particular, is there any risk group or chronic condition that should probably avoid vaccination at this point?

Dr Cook : I'm not aware of anything specific—and I actually have the product information in front of me—of where there have been any particular contraindications. The only contraindication is hypersensitivity, which is a reasonable one, and we have seen that there have been some serious hypersensitivity reactions. There are some special warnings. I think there was some concern about whether or not the efficacy might be lower in immunosuppressed individuals, so people who either had an immunosuppressive condition or were being treated for a condition with immunosuppressants. They seem to be the two major areas. For people who have autoimmune conditions, there often are concerns around vaccines. They haven't said anything specific, but that is certainly an area we would be looking at. I think, at the end of the day, it becomes a decision between you and your clinician about your risk. If you're immunosuppressed, you probably do not want to get COVID.

Dr MARTIN: Yes.

Dr Cook : They're the only specific ones that I can see in the Pfizer vaccine. Obviously, I don't have access to the AstraZeneca product information, but there will be similar information in the product information for a specific population. Certainly, it always seems to be around the immunosuppressed and the autoimmune that we have concerns and where we would be focusing our monitoring and, I'm sure, where other regulators already have focused their monitoring.

Dr Murphy : It's important to know that none of the vaccines that we're getting have no live virus in them, so there's not a risk like there is with some live-virus vaccines where immunosuppressed people are at risk of getting—

Dr Cook : I would be encouraging people to get the vaccine. In some of the studies for the vaccines that were done in South Africa, a lot of those had HIV, and there certainly was nothing different in that population that emerged.

CHAIR: Ms McBride, do you have another question?

Ms McBRIDE: Yes, I have a question in relation to pharmacists and the participation of pharmacies in, I understand, phase 2 of the rollout. From what we covered earlier, I know expressions of interest were sent to GP practices as well as to pharmacies last weekend. Is there an early update on where that's up to at the moment? Given their footprint across Australia, community pharmacies and pharmacists are going to be critical in the rollout to the wider population.

Dr Murphy : I think it's probably too early to get—the EOI has just opened on it. I don't have any current data on the response. We know that a number of pharmacies are responding, as a number of GP practices have responded. I think we are setting some fairly stringent conditions for a pharmacy to set up vaccination. We will review those as we get more and more experience with the vaccines over time. But to be able to be a vaccination clinic—again, it's not like the flu vaccine. We've got to be able to deliver no wastage, have the right facility and have all the right support structures. Mr Peisley and her team have done a lot of work to define that. We expect a strong response from pharmacists, as we've had from GPs, but I don't have any data on that.

Dr ALLEN: My question is with regard to the marketplace. Firstly, has any thought been given to an evolution of the black market with regard to vaccines? Secondly, congratulations on having a diversified vaccine portfolio, particularly when we don't know—the three aspects are severe disease, prevention of disease and prevention of transmission. But, going forward, it could be that we have to administer this vaccine on an annual basis to a whole population, and it will be extraordinarily expensive, so, from a market based point of view, I think having a diversified portfolio is also very sensible. Would you be able to make some comments around that?

Dr Skerritt : I'm your black market man! One of our responsibilities, for better or for worse, under the Therapeutic Goods Act that we administer is black market medicines and vaccines. Indeed, there was a massive and sad number of black market tests, masks, medicines and antivirals of all different sorts that were claimed to cure it. We had over a thousand cases, just to give you an idea of scale. We had teams, many of whom are ex-ASIO or ex-police working on this. We work very closely with Border Force. They refer to us anything that's suss that they pick up that comes through. 'Suss' is a technical term.

On vaccines, it's a bit different. Yes, you can go onto the web and find crazy ads saying that for four bucks you can get your Pfizer vaccine now. We do, however, have to be aware of the fact that the government, especially with the extension of the availability announced yesterday, has been at pains to say, 'You can get this for free.' So it's not a case of saying, 'Look, normally it'd cost you $200 to get this, but we can sell it to you for $50.' In that way, the black market will be a bit disempowered. There will, as we heard from a Canadian case recently, potentially be people wanting to be queue jumpers. If you're a fit 30-year-old but you're very worried about getting sick, you might want to get this thing in February. We are very carefully watching promotion. We're taking action where we can trace it to an Australian address. If it's a web address in Russia, we can't touch it because it's offshore. But if it's onshore, we're doing close monitoring of black market promotion, and we're also getting referrals to us from Border Force. So far, it hasn't been a significant issue, but we've also been doing a fair bit of intelligence work into the likely potential sources and groups. I shouldn't name countries, but the Chinese diaspora have been a bit of a risk in some of the other black market activities around COVID medicines and masks and tests. We're also spreading that message, or an educational sense, that there's no need to go and try to get your vaccine on the black market.

Mr ZAPPIA: Once you get vaccinated, will you have to be vaccinated in, say, 12 months time?

Dr Skerritt : If you know the answer to that, could you tell us! That's the $64 billion question. And that, of course, is one of the primary questions that people following this epidemic are asking. We hope not. There are two possibilities: either the current vaccines don't provide long-term protection per se, or there is antigenic or virus strain drift. It'll possibly be a combination of both. So it may well be you'll have to have Pfizer mark II in 12 months time because the virus, whether it's the South Africa, Brazil or UK strain, will have changed enough that you'll need a more efficacious boost in 12 months time. Or it could just be the inherent characteristics of a vaccine for a disease that you need to be boosted in 12 months time. That's another reason why these discussions with companies about second-, third- and fourth-generation vaccines are very important.

Mr ZAPPIA: Thank you.

CHAIR: The last question is from Ms Bell.

Ms BELL: Thank you very much, Chair. I'll make it very quick. Professor Murphy, you stated a couple of times today how important the domestic manufacture of COVID-19 vaccines is. Can you discuss any incentives given to industry here in Australia to manufacture those vaccines domestically?

Dr Murphy : There was a commercial agreement between the government and CSL to technology-transfer the AstraZeneca vaccine. CSL are being paid for their work, as is AstraZeneca. There was a commercial-in-confidence discussion. CSL are being appropriately paid for the work they're doing. The government recently announced we have a long-term commitment with CSL's vaccine subsidiary Seqirus for long-term investment in a new vaccine manufacturing plant, initially for flu vaccines but also for antivenenes and Q fever vaccine. There's a very longstanding commercial relationship where we provide incentives and support for CSL, and that's been extended for a prolonged period. Finally, there's been a lot of talk about whether mRNA vaccines are perhaps the new horizon on vaccines. The minister for industry is commissioning some work to see what the potential is for onshore manufacturing—probably not in the short term but in the longer term—of mRNA vaccines in the future.

CHAIR: I thank all of you for your participation today. Hopefully we were a bit more pleasant than our Senate colleagues! We always are—

Dr Skerritt : No!

CHAIR: Dr Skerritt, she won't be invited back, which will probably be a blessing! If anyone took any questions on notice, if they could provide them to the secretariat by 26 February it would be much appreciated. We really do value your time today, but, more importantly, everything you're doing for the nation. Thank you for being with us.