VIRGINIA TRIOLI:
But as part of that discussion, we originally did want to get Adjunct Professor, John Skerritt, who's the Deputy Secretary of the Therapeutic Goods Administration, otherwise known as the TGA, which is the approval process for drugs that come to market here in the country. We wanted to get him in that conversation too, because he's the one who can talk to you about the regulatory regimes we have in place, what vaccines and other drugs go through before they're able to be administered and prescribed here in Australia. And I'm delighted to say that he has time for you this morning. John Skerritt, really good to talk to you. Good morning.
JOHN SKERRITT:
Yes. Good morning, Virginia, and it's been an extremely busy week, of course.
VIRGINIA TRIOLI:
Of course it has been. And your busyness is not going to end anytime soon, John Skerritt.
JOHN SKERRITT:
Sadly not.
VIRGINIA TRIOLI:
[Laughs] Well, sadly I guess, in one term, but kind of happily in the other, in that we now have the rollout, which is a great thing.
JOHN SKERRITT:
And we also have some fantastic results coming in from overseas …
VIRGINIA TRIOLI:
[Talks over] Yes, let's talk about that first, actually, you're right. Out of Israel, in particular, I think you're referring to, is that right?
JOHN SKERRITT:
Well, not just Israel. There's some really excellent results on both the AstraZeneca vaccine and the Pfizer vaccine coming from Scotland and also from England. So, three separate countries, separate independent studies all showing that both vaccines are performing really well. And I know a lot has been made about whether one vaccine is better than other, but ironically, in the Scottish data, the AstraZeneca came up 10 points higher. And I've said many times, there's not really a difference between 80 and 90 per cent in these sorts of trials, I mean, both are excellent results. But the AstraZeneca one has reduced the risk of hospitalisation by 94 per cent, and this is real world data with over a million people vaccinated in Scotland. The Pfizer reduced it by 85. Again, an excellent result.
VIRGINIA TRIOLI:
Well, that's fantastic. So just briefly take us through the results, the headlines as you see them, from the results that have landed on your desk overnight?
JOHN SKERRITT:
So, from Scotland they have looked at everyone vaccinated until about a week and a half ago, and they've done 1.1 million vaccinations. And they found that, as I said, the AstraZeneca reduce the risk of hospitalisation almost completely, 94 per cent and Pfizer by 85 per cent. And the good news is that was held by both groups, because I know there's also been some comments about AstraZeneca and older people, but both vaccines reduced by more than 80 per cent hospitalisation in those over 80. So, that's the Scottish result.
The British result is similarly outstanding. The good news on the British result, and it was- the stuff they've published from England, Public Health England, which is part of a government. And their real world analysis so far is on Pfizer, but they've told us that there's similar and promising results with AstraZeneca. Their results there is it's starting to show that it is impacting on transmission, because that was one of the big things we didn't know.
VIRGINIA TRIOLI:
Absolutely. So what do we know about transmission?
JOHN SKERRITT:
Well, what they did in England is they actually tested even people who weren't sick. These were health care workers, and so the question is, if you're vaccinated as a health care worker, is a vaccine, apart from preventing you getting seriously ill, is a vaccine stopping transmission? And so, they tested even healthy health care workers and it showed that the vaccine presented both what's called a symptomatic infection, when you get the symptoms, and asymptomatic infection, where, as we know, especially with younger people, a lot of people who catch COVID don't get ill, but there's always a chance of them passing the disease on.
VIRGINIA TRIOLI:
That's right.
JOHN SKERRITT:
And the result in England actually showed that it was actually impacting on transmission, and that's a fantastic result.
VIRGINIA TRIOLI:
So when you say impacting on transmission, is it drastically reducing the likelihood of transmission?
JOHN SKERRITT:
Drastically reducing. Now, the results are early. But even a single dose appears to reduce the risk of catching infection by over 70 per cent. And once you have your two shots - and remember, with Pfizer, at least in Australia, we're encouraging people to have those two shots three weeks apart - more than 85 per cent reduction in the risk of catching infection. And so, that's fantastic news.
VIRGINIA TRIOLI:
One thing I just want to clarify, because the benchmark we seem to be using here, particularly in relation to that comparison you've talked about with the Pfizer- sorry, with the AstraZeneca, is as effective as the Pfizer one. You use the phrase there, hospitalisation. We've been using the phrase, you know, the onset of serious illness. Is that the same thing?
JOHN SKERRITT:
Look, they're essentially the same. If you are seriously ill with COVID, you would be hospitalised. Hospitalisation is something that can be measured easily through admission records, and when you've got 1.14 million test cases, it's better than a doctor saying, are they seriously ill or only moderately ill? If they've been admitted to hospital, it's a yes, no measure. So, that's why the most objective measure here was actually hospitalisation. But it's really the same thing as serious illness, because there are a number of COVID cases, including those that were treated in Australia, where people don't have to go into hospital, they can stay at home.
VIRGINIA TRIOLI:
Well, that's really interesting. John Skerritt is with you. Adjunct Professor John Skerritt, Deputy Secretary of the Therapeutic Goods Administration. We've had many questions, they were asked and answered, I think, the other day. But I reckon it's always worth revisiting this. John Skerritt, because these vaccines went through a more accelerated process than probably any other vaccine that's been brought to market before, does it follow logically that some steps have either been skipped, missed or compressed in time, that maybe it's not been tested as much as a vaccine in the past?
JOHN SKERRITT:
There's actually two parts of this. So in the development of the vaccines, this was probably the biggest investment in medical development, medical research and development that I would say the world has ever seen. Full stop. In terms of thousands, if not hundreds of thousands of scientists and company people, and billions, not millions, but billions of dollars.
Now, there are some things we don't know about these vaccines that we often will know about other vaccines by now. And the biggest thing is whether these vaccines provide protection for one year, five years, lifetime. That's the main thing we don't know. But the preliminary data is out at eight or nine months, is looking pretty good, that there's protection. But that's not the same as five years. That's the main thing we don't know. But as far as the rest of it, and especially the evaluation, we in Australia were just as thorough as for any vaccine. The way we did it faster was have multiple teams of people working in parallel rather than sequentially. And sadly, we had a lot of people who have been working seven days a week on this stuff for months.
VIRGINIA TRIOLI:
Yes, but at least they've been part of one of the most important moments in their lives, in our lives.
JOHN SKERRITT:
Yes, when I cheer them up, and it's hard to cheer up tired staff, but our staff have been fantastic. And when I cheer them up, I say you are probably doing the most important thing you will do in your whole career now.
VIRGINIA TRIOLI:
Well, that's one heck of a pep talk, I reckon, and that's what they want to hear. Where's the Novavax approval at?
JOHN SKERRITT:
So it's still rolling out its phase three, the final large set of trials. One of the things about vaccine trials is that they're what doctors and regulators call event driven. Now that's jargon, but what it means is that you have to wait until a certain number of unvaccinated people in the so-called placebo arm - where people have had another vaccine or a shot of saline, but not the coronavirus vaccine - a certain number of them get ill with coronavirus, are positively diagnosed with coronavirus. And that's the events that they're talking about. So in a way, the length of the trials is determined by external factors. And if, fortunately, the numbers of cases go down as they have in the US - even though we've passed the sad milestone of half a million deaths just earlier this week - if the numbers of cases go down in a particular area because of social distancing and all the other measures, hand sanitisation, it takes a bit longer to get up to, say, 90 or 100 cases or whatever the predetermined cut-off is in the trials for the so-called placebo arm. So what I'm saying is there's not a black and white date where we will be adamant we'll have the data. We've received a regulatory submission. We have the data from them. But it's what we call a rolling submission because we get bits and pieces of data as it comes along. It may well be- it could be April, but it could be May, May or June or even later and it just depends on that. There's also manufacturing, because the challenge with a vaccine is making it the same way every time. And that vaccine is a really interesting one. It's made of insect cells.
VIRGINIA TRIOLI:
Wow. I didn't know that. Insect cells.
JOHN SKERRITT:
Yes. So the way- so it's actually a protein, but it's a copy of the protein of the virus, but it's not infectious. And the genes are actually put into insect cells. And so there are ways of growing insect cells up in incubators. So you don't have to go and catch the moths to go and do this. But it's actually the cells from a particular insect that are grown in incubators. And again, the company is rolling out a whole lot of manufacturing sites throughout the world. So getting the manufacturing consistent is also part of the development of a vaccine.
VIRGINIA TRIOLI:
I have to let you go, and I'm keen to hear from Jane Norman, who's joining you next with our political wrap of the week. But just finally, this very, very precious vaccine that the world is waiting for, that countries are fighting over in order to get their hands on, we have just learnt that there's been a, I'm afraid, a bit of a stuff up with the vaccine rollout. It seems that a batch of injections have spoilt at an aged care centre in Werribee. Just wondering what your response to that is, John Skerritt?
JOHN SKERRITT:
So in the rollout, we're looking at that, and clearly there's protocols because of the sheer value of the vaccine. So in the approval, there's actually very clear instructions about the handling of the vaccine, how long particular vaccines can go outside being on dry ice or outside of the fridge. It's a little bit like your milk container. How long once you open the vaccine, you can put it back in the fridge. And frankly, one of the advantages of the AstraZeneca vaccine is that it can go back in the fridge once it's been opened for a limited period of time. But the rollout team, which is a separate team, is actually looking at any of these glitches. Now, human nature is such that we will have a few small glitches, but the fewer the better.
VIRGINIA TRIOLI:
Okay. It is a bit of a loss of this precious thing, though, to learn that it's been spoilt.
JOHN SKERRITT:
And it's something that the team is looking at, whether there has been what we call a breach of cold chain.
VIRGINIA TRIOLI:
Okay, so you're aware of the spoilage, are you, John Skerritt?
JOHN SKERRITT:
I am.
VIRGINIA TRIOLI:
Yeah. Okay. Do you know when took place exactly?
JOHN SKERRITT:
No, I don't know the details. As I say, that's a separate team within the Department of Health. But they are working- I do know they're working closely with all of the states and territories to minimise incidents such as this.
VIRGINIA TRIOLI:
Really good to talk to you, John Skerritt. Thank you for your time. Good luck.
JOHN SKERRITT:
Okay, thanks very much.
VIRGINIA TRIOLI:
John Skerritt there, Deputy Secretary of the Therapeutic Goods Administration.
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