ALI MOORE:
Well, should we be worried? No roll-out will start until the Therapeutic Goods Administration, which is the body responsible for giving the vaccine the go-ahead, does just that. John Skerritt, is the Deputy Secretary of the Department of Health; he's responsible for the TGA, that makes him the boss of the TGA. John Skerritt, good morning.
JOHN SKERRITT:
Good morning, Ali.
ALI MOORE:
I'll get you to take us through the vaccines that you're assessing in just a minute. But first, some broader questions to address the concern you just heard in that caller there. Does faster approval mean less safe approval?
JOHN SKERRITT:
No, it doesn't. I guess what's important to emphasise is that normally in an approval you might do things sequentially - you might have one team looking at, say, what it does in rats and mice before you go on to another team looking at what it does in humans and so forth. What we have done is actually assemble teams working at the same time. We've also, and much to the pain of my staff, had teams working weekends and throughout Christmas and New Year. And so, because we're working many hours a week, and because we've got many teams working in parallel to each other, and we're also working close with other major countries like Europe, like the FDA and so forth - look, we're not cutting any corners at all.
In fact, as you know, the criticism has been well why is Australia taking longer than say, the UK? The answer is, we're being exactly as thorough as for any other vaccine that is going to the market. We haven't had an emergency use or authorisation which is based on less data. We're looking at the same amount of data, in the same amount of thoroughness; it's just that our processes have been changed to enable us to get this vaccine on to the market as soon as we believe it's safe and effective.
ALI MOORE:
At the same time though, I guess, the point of those who are concerned is that it's a simple time period. So, you've got less time, that's one thing you can't speed up, is the impact over time. That is not of concern?
JOHN SKERRITT:
So, the first shots of these vaccines, the first two candidates we're looking at, went into people in, well, it would be quarter to mid-2020, so there's now a full six months or more experience with that first group of people. And indeed, it's remarkable for Australia to get a vaccine that has now been in somewhere between four I think and maybe six or seven million and as soon as you quote a number it changes by the day. But, because of a very significant roll-out under emergency provisions in the US and the UK, for example, for the Pfizer vaccine and in other countries, we've actually been able to monitor very closely any serious adversary actions. And so, we've seen for example that there are some people who have a condition - an allergic like condition, called anaphylaxis, the vaccine should be avoided in. But, the good news is that there haven't been any really serious adverse events other than that. So, we've actually had the experience of several million people in the northern hemisphere that we can reflect on, and we're talking to our equivalents in the northern hemisphere everyday about what they're finding.
ALI MOORE:
So, what exactly - given that you have got several million people, as you say, it's changing there are really rapid roll-outs across the world now, including in Asia - what is it that you're waiting for? What is it that you haven't got, that they've got? And I understand the emergency approvals, but does that imply that those that are getting it in the US or UK or Singapore or Israel or Canada are not getting it safely?
JOHN SKERRITT:
I wouldn't want to say they're not getting it safely. What we are getting is - and again, I heard your earlier caller - what we're getting is the full amount of information that we would get for a vaccine for a regulatory approval. Whereas, those countries have done this emergency authorisation, based on what we- what they're able to get at the time. So, we've been able to get more -
ALI MOORE:
[Talks over] So, what's the extra bit?
JOHN SKERRITT:
Well, we've been able to get more information, for example, on the stability of the vaccine. We've been able to get the clinical data analysed. We've had the extra two months of experience and that's, for example, where these anaphylactic reactions have been picked up and we now know there's certain people who should not, for example, receive the Pfizer vaccine. So, there are a number of additional things that Australia has had the ability to receive, because we are looking at making a decision in the next few weeks in January, as opposed to, say, at the beginning of December.
ALI MOORE:
So, what will you get in the next few weeks that you haven't got now?
JOHN SKERRITT:
So, in the next couple of weeks - and remember we're talk- today is 8 January and we're talking only about a few weeks' time until we anticipate being able to make a decision on the first vaccine - we're going to get the final information, so called risk management plan. This is the plan to manage any safety incidents, and that's being finalised with the company. We're finalising the information for doctors and those who'll be vaccinating about what populations and what groups to watch out for. We also, next week - a week from today - have a meeting of a very important expert committee; these are infectious disease experts from around the country, who independently will double check our work and provide advice on any gaps.
And again, this is the normal process for other vaccines because, as your caller indicated, it's all very good having a vaccine a month or two earlier, but, the most critical thing is for people to have confidence that this vaccine is being looked at in the same degree of scrutiny as any other vaccine. And that's why these steps, taking a couple of weeks extra, is so important because vaccines sitting in bottles in refrigerators are useless - it's vaccines that are in people's arms that avoid a disease, or avoid spread of the disease are what add(*) it.
ALI MOORE:
Of course though, there are plenty of people who have the opposite view to our caller yesterday. And that is particularly with this new highly virulent strain that is already in the country, albeit in hotel quarantine, although now in one cleaner who works in quarantine. People are worried, and you know yourself a lot can change in a few weeks. So, many people think, well, they're getting it overseas, millions have got it, why can't we? What are the chances you're not going to approve it? And if you don't, do we just not get vaccinated?
JOHN SKERRITT:
Look, I'm not going to speculate on whether an approval is or isn't going to be made. It's a little bit like saying, and the final result is such and such in a football game at half or three quarter time.
ALI MOORE:
Is it really that uncertain? I mean, the Prime Minister's come out and told us we're-
JOHN SKERRITT:
[Interrupts] It's highly likely that the vaccine will be approved, and the question is whether there are particular conditions that are put on. There will be some conditions for sure, because nobody in the world knows, for example, how long these vaccines last in terms of their protection from the disease. But, some encouraging data just out overnight that suggests that the immune system is still fighting coronavirus eight months after the initial infection. But, because no one in the world has had these vaccines for one, two, three, four or five years, we don't know how long, for example, the vaccines last. And so, that's the sort of information that we'll be requiring companies and others to report back to us, for us to analyse to work out whether people have to be re-vaccinated, or whether this is a one shot that'll last many, many years. So, there's a lot of unknowns still.
ALI MOORE:
[Talks over] Gosh, if it's only eight months, we could actually be starting again before we're finished.
JOHN SKERRITT:
Well, we simply don't know that, and that's why not only at this stage many countries, including Australia, are buying several vaccines. But, there's another 20 or 30 vaccines that are seriously through commercial development, and going through commercial development. And we're talking to- we've talked to at least 15 or 16 developers of other vaccines because it may be that, while these first vaccines attracted so much media, it could be that vaccine number six or seven actually turns out to be the best of all.
So it's a continuous development program, and just about every major pharmaceutical company and many major academic and research institutes are developing vaccines, because - whether it's the percentage of the population covered; whether they're more effective in kids; whether they're more effective at working with asymptomatic people; or whether for example, they provide lifelong protection; we simply don't know those answers. And that's why it's worth the while to not only develop vaccines one and two, but to work on vaccines three to 20.
ALI MOORE:
We're talking, of course, one and two, the Pfizer vaccine and the Oxford-AstraZeneca vaccine.
JOHN SKERRITT:
[Talks over] Correct.
ALI MOORE:
You're listening to John Skerritt, who's the head of the Therapeutic Goods Administration. John Skerritt, the question that everyone has after the one of safety is, will these vaccines actually stop you from getting it? Or just minimise how you respond to it? And once- if you have been vaccinated, can you still transmit it to others?
JOHN SKERRITT:
So they're questions that are obviously exercising a lot of our focus, and also the focus of overseas regulators, and we don't have black and white answers to that - I'd be misleading you to say that. Generally, though, there's a relationship that if the vaccine prevents or decreases the severity of disease, usually there- it means that the transmissibility is decreased. But we simply don't know, and it may be some months for any of the vaccines until we have clear information as to prevent asymptomatic transmission. And that's why, as other people in public health have been saying, it's- vaccines are part of the armoury, we're still going to have to socially distance. We're still going to [indistinct]...
ALI MOORE:
[Talks over] We need hotel quarantine as well.
JOHN SKERRITT:
… hand hygiene. Quarantine will play an important role. Now, we're all hoping that sometime in the future - and hopefully not a decade, hopefully a year or two in the future - life will be a lot more like it used to look. But we have to be absolutely crystal clear that the day a vaccine arrives, the world does not go back to 2018 or 2019. So we're going to have to continue to keep our wits about us and have these other forms of keeping us COVID safe.
ALI MOORE:
You say that we don't know if it prevents asymptomatic transmission, but you also said we've had it in people since sort of either the third quarter or the halfway through last year, so that's six to eight months. Surely there must be some indicator from that as to whether people who were vac-
JOHN SKERRITT:
[Interrupts] There are. So the people who have been- there isn't evidence that people have been vaccinated who have recourse COVID. There's a small number of cases people where have been naturally infected with COVID who appear to have caught COVID again, although there's a degree of argument out there as to whether some people have kept the original virus in their system and never really got rid of it.
But what we haven't seen is evidence of people who've been vaccinated who've caught it again. This is the sort of data that does accumulate, but generally, if we can get a vaccine out there that prevents the severity of the condition, it usually follows that some of the other measures do align. But there's only a very small number of vaccines that totally eliminate transmission of disease and so vaccines are always one part of the public health response to any contagious disease.
ALI MOORE:
In the UK, authorities are extending the time between the two doses of the Pfizer vaccine from three weeks to 12 weeks, and they're doing that because obviously they're in an emergency situation and they need to increase supply. Will we do that too to hasten the roll out?
JOHN SKERRITT:
Again, that's part of a final decision. But at this stage, there's not a sense that we need to do that in Australia. And even in countries like the US, and we've got to remember - this is a pretty sobering statistic, in the US the number of deaths due to COVID is greater than the populations of Geelong and Bendigo combined, I mean, that's a pretty sobering statistic. But even against that number, the US has made a decision and they've put an announcement out in the last 48 hours that they're not going to extend the gap in vaccinations for Pfizer or Moderna vaccines up to a couple of months, because they want to follow what was tested in clinical trials. So it would not normally be usual to change that. But the British have because, sadly, the situation is just so dire there. Remember more than 2 per cent of people in the whole country have now contracted COVID - that's a frightening statistic.
ALI MOORE:
It is indeed. So does that mean that any TGA approval will also govern that gap? That that will be up to you to say, yes, we approve this vaccine but only with two doses over this period?
JOHN SKERRITT:
So that will be the official approval. There's an interaction between what is in the regulatory approval, and then what guidance is put out to doctors and nurses and vaccinating groups. And that's where another group, who actually have a lot of overlap and we work closely with them, called ATAGI is involved. So there's an interaction between what we agree to approve in a regulatory sense, and then the priority for roll out, the priority population groups, and the advice on dosing. But at this stage, it's not anticipated that Australia would go to a two or three month gap between doses because we believe the current data is not sufficient to support that.
ALI MOORE:
Do you have any understanding of how the vaccines will affect this new strain of the virus? And indeed any, we know it's going to continue to mutate, any new strains that we will have in the future?
JOHN SKERRITT:
Well, viruses mutate all the time, generally at different rates. And the rate of mutation, of course, is a reason why we all need to front up every autumn and have a new shot of the flu vaccine because it mutates very quickly, the flu.
Coronavirus, the COVID-19, does mutate and it's been mutating all along. There's two mutations, of course, that are of particular interest at the moment because they seem to have increased its transmissibility, and that is a concern. To date, the data seems to suggest the vaccines will be effective against those mutations, but obviously that's something very much front of mind- not only for the companies and the public health people, but also the regulators. But the data today seems to indicate that they should be effective. And that's mainly data that you can do at the test tube level, because we actually know what the changes to the structure of these mutants is if you're using modern DNA techniques.
ALI MOORE:
John Skerritt, just before I let you go, just to clarify, the ones that you are looking at. You're looking at the Pfizer/BioNTech, and you're looking at the Oxford-AstraZeneca. Are they both on the same path? Or is the Pfizer one likely to be approved within weeks and Oxford a little later?
JOHN SKERRITT:
We're expecting to approve the Pfizer one during the course of this month, and that's obviously subject to the advice of this expert group I've just mentioned. It is ahead of the AstraZeneca one by a period of a few weeks. But as I said before, we've been talking to a dozen or so other companies. Now, some of those companies and research groups have only just started clinical trials, and so it would be the end of 2021 before you'd expect the product to come to a regulator for approval. Others have already done thousands or even in some cases tens of thousands.
So this is, to use a cliché, a marathon, not a sprint. It will be important for us to work on the AstraZeneca and Pfizer vaccines in the next couple of months in intense detail. But for example, next week we're having a long meeting with another company who is fairly well advanced. And we've be meeting with a dozen or more other companies on and off over the last seven or eight months already on their vaccine development.
ALI MOORE:
Wouldn't you prioritise the Oxford one though? Only because it's far easier to move around, it doesn't have that minus 70 degrees requirement. And we can also, as I understand it, produce it here. CSL has a licence to so do.
JOHN SKERRITT:
So, Ali, there are a lot of advantages to the AstraZeneca one, and it's not a case of prioritising one over the other - we have separate teams who are working on both. And so there's one team of doctors and scientists and regulatory specialists working on Pfizer vaccine, there's another team working with the AstraZeneca vaccine. We do expect Pfizer will come to the finish line first, but it's not a case of one team having to do it at the expense of the other team.
ALI MOORE:
Well, John Skerritt, we very much appreciate your time. We know you're busy. We do want you to get back to assessing those [laughs].
JOHN SKERRITT:
I'll get back to work.
ALI MOORE:
Get back to work. But yeah look, thanks for explaining it to us and clearing up some of those questions that we had. It's very much appreciated.
JOHN SKERRITT:
Thanks very much, Ali. And good morning to listeners.
ALI MOORE:
John Skerritt there. He's the Deputy Secretary of the Department of Health. He's responsible for the Therapeutic Goods Administration, which means he's the boss of the TGA, and it's the TGA that gives the yea or nay to the vaccines.
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