RAFAEL EPSTEIN:
Professor John Skerritt is the head of the Therapeutic Goods Administration, thanks for joining us again.
JOHN SKERRITT:
Yes, good afternoon, Raf. Always good to talk with you.
RAFAEL EPSTEIN:
Can you explain the decision around Moderna, please?
JOHN SKERRITT:
Yeah, so we actually have ticked the box, not almost ticked the box.
RAFAEL EPSTEIN:
Sorry.
JOHN SKERRITT:
So, yesterday- no, it's brand new news. So 24 hours ago, about this time yesterday, we issued an approval for the use of the Moderna vaccine in people over 18.
RAFAEL EPSTEIN:
What does that mean? Does that mean that they can just ship it in and you never look at that stuff again and they can send it out to every hospital? Do you have any more involvement?
JOHN SKERRITT:
We certainly have, as I was saying to the Prime Minister when we did the press conference, our work's 20 per cent done. Because we monitor the safety and also the quality of the vaccine through its whole life cycle. If it's on the market in Australia for one year or for 20 years - some of the vaccines we've had in Australia have been on the market for 50 years - we look at every batch of a vaccine, we test every batch of a vaccine. Or there are a few cases where some of the laboratory testing is done by labs we work with overseas but-
RAFAEL EPSTEIN:
[Interrupts] You test every batch?
JOHN SKERRITT:
Every batch and we also monitor very carefully the safety. So especially- no medicine or vaccine is, you know, 100 per cent free of adverse events. So we play a very significant role in monitoring adverse event reports to see if they are due to a vaccine, and if they are to have a role in modifying the advice as to who should receive that vaccine.
RAFAEL EPSTEIN:
If I can ask a cheeky question in some ways. Why do we need you? Like I mean, there are people in America, the Food and Drug Administration, they tick off on, I don't know, Pfizer or something. Why do we need to do it ourselves?
JOHN SKERRITT:
Well, a couple of reasons. Well, first of all, we're part of an international network. So even though we're much smaller than the Americans, we work together with them on a lot of medicines. And our people have a role in advising on their approvals as well, especially in the case of Americans for cancer medicine. So it's not that all the regulators duplicate each other's work in isolation. We work as a big network and in fact, almost every night of the week, because it is night time here in Australia, I've got staff talking to the Europeans, the Canadians, the Japanese, they're a bit more sociable in mere hours because of time zones. So it's really a network and especially as IT has improved, it's really become a virtual network of regulators.
Why do we still, at the end of the day, make an individual decision and want to have a copy of all the data here in Australia? It's been tremendously useful because when adverse events do appear, we can get on top of them earlier. We can adjust the clinical advice. And so if I can use a very dour statistic, but it's a very immediate one. With AstraZeneca, we know that there's a very rare serious adverse event and the number of deaths and very serious adverse events that have occurred in Australia, while there have been some tragic events, is much, much lower, for example, than in the UK. And the reason being is that we were able to get all the global information and get on very early to work out in Australia how to manage patients who might show any signs of side effects. So having all that information and making the final decision within the country actually saves lives.
RAFAEL EPSTEIN:
Which vaccines have you approved…
JOHN SKERRITT:
[Interrupts] So we've approved- for COVID?
RAFAEL EPSTEIN:
Well, no. I just want to know what you've approved for people under 18, because I know some indigenous kids and kids with medical conditions- so which vaccines have been approved for those under 18?
JOHN SKERRITT:
So the ones that are approved for under 18, so far it's the Pfizer. But Moderna has this application in front of us for under 18s and over the next three to four weeks, I'd say maximum, it depends on Moderna's response, we expect to make a decision. The Moderna data also looks pretty good for me under 18s but we've obviously got to go to our committee of experts and then back to the company. So barring big problems, I'm expecting that by the time Moderna lands in Australia, it may also be approved for the under 18s but I shouldn't pre-empt that decision.
RAFAEL EPSTEIN:
And I think it's 12 plus at the moment for Pfizer, is that correct?
JOHN SKERRITT:
So for Pfizer, it's 12 to 17. Is the approval. Now, again, like everything, Australia is prioritising which groups get that vaccine. And so the advice is that in the 12 to 17-year-old range, it's essentially kids that are at higher risk, the same way we had adults in the initial rollout who were at higher risk, rather than all kids. And the debate is still open about the relative merits of vaccinating all children and teenagers versus those at high risk.
RAFAEL EPSTEIN:
Has anybody - Pfizer, the AstraZeneca or Moderna - have any of them asked you to approve their vaccine for kids under 12?
JOHN SKERRITT:
No one has submitted an application for kids under 12. Now, in some countries, there's clinical trials going on in younger kids. Now especially with younger kids, safety is paramount and you're wanting to make sure that the risks of those vaccines, you know, are not significant and the benefits are significant. And that's the same say with flu vaccines. So most flu vaccines start their life by being approved in adults but as you know, we routinely vaccinate young children for the flu because they can get very ill. And so we are looking at trials overseas. No one has yet applied in Australia for kids under 12.
RAFAEL EPSTEIN:
But you'd expect that, wouldn't you? You'd expect those applications?
JOHN SKERRITT:
I will expect in the coming months that we will receive applications for kids under 12 and we'll look very closely at the safety data.
RAFAEL EPSTEIN:
Is it quicker if you've already approved it for, say, the over 12s? Is it- does it mean it's a simpler, quicker process for the under 12s?
JOHN SKERRITT:
Oh, it is, because- yes, you're looking specifically at how well it works in those kids under 12 and you're looking at the safety data for the kids under 12. You're not looking, for example, at how it's manufactured because it's the exact same thing.
RAFAEL EPSTEIN:
Professor John Skerritt is with us, he is the head of the Therapeutic Goods Administration. Professor, I don't want to engage too much with misinformation, but I do want to engage with, I guess, vaccine hesitancy. Some people might think the vaccine hasn't been around that long, how do I know it's going to be any good? Can you just give an overview? The vaccines you've approved for COVID and the trials that those drugs have gone through, how do they compare to previous vaccines?
JOHN SKERRITT:
Well, you're right that the timeframes are being compressed. But the numbers of patients actually involved in the clinical trials before approval were actually very large as far as clinical trials go, many more, for example, than, say, cancer drugs or heart drugs or even trials of a flu vaccine. So the clinical trials typically had 20, 30, 40,000 people in these trials, and they also were conducted in environments where there was a lot of natural infection. Sometimes with vaccines, you might develop a vaccine for a condition and then that infection doesn't come along. So the real world experience of the trials is very significant and I guess what's more so - and this is where Australia does benefit in a way from being a few months behind as far as the drug companies coming to us - so Moderna went to the Americans in October, November last year with their initial submission. We only received their final submission in 8 July this year. So big difference, but it means that 140 million Americans have had this Moderna vaccine, some of them now for eight and nine months. And so we've been able to look at the experience and adverse events, which are rare with this product, but also the tremendous of it to protect people from getting sick or hospitalised or dying with COVID. So we can benefit from experience, it's a bit like the McDonald's hamburgers when you have millions sold and millions consumed, but we've been able to benefit from hundreds of millions of people globally having had these vaccines.
And getting- and there's a lot of real world evidence that even though sometimes people can still get mild COVID after they've been vaccinated, you only have to look sadly at the difference between Sydney and in terms of aged-care deaths with the current outbreak up there, and what we all had in Melbourne last year. Now last year, we didn't have a vaccine in this time last year. And in Sydney, even though there are some deaths and every death's tragic, we haven't had the 30, 40, 50, 60 some days largely in aged-care. And that's because of vaccination. It's preventing people from getting seriously ill and dying.
RAFAEL EPSTEIN:
So in some ways, these are the most tested vaccines, are they? Compared to any other vaccine?
JOHN SKERRITT:
[Talks over] Well, in some ways you could say they are. Now the flu vaccine, of course, has been around for years, but, of course, it's different versions because the flu changes every year. There's other vaccines like measles, mumps, and rubella, and diphtheria, and tetanus that have been around for years, and have been in many, many children. But just the sheer number of people who are getting these COVID vaccines gives us the ability- and the fact that we can capture data so well now compared with 20 or 30 years ago, really means in some ways some of these vaccines are the most tested.
RAFAEL EPSTEIN:
I want to ask an explicit question about AstraZeneca. Are you confident that it's safe to sell and use in this country?
JOHN SKERRITT:
We are confident that the benefits significantly exceed the risks. Now, any medicine - and that can even include Panadol - any medicine, any vaccine has a certain amount of rare side effects. And there are rare side effects, and with AstraZeneca - as indeed there are rare side effects with Pfizer and indeed any other vaccine outside the COVID area - we have to get on to those rare side effects early. We have to give the best clinical management to the patients who have those rare side effects. But if we didn't have AstraZeneca, we wouldn't be talking about two, three, four or five deaths in Sydney at the moment. If AstraZeneca hadn't been vaccinated in New South Wales, we'd be talking about deaths in their dozens every day.
RAFAEL EPSTEIN:
Can you explain- just the Moderna vaccine, the dose is a lot bigger, I think, than the Pfizer. Is that correct? And I wonder why that is?
JOHN SKERRITT:
It's about double. It's still 100 micrograms, which is not much. It's basically the way it's put inside as it comes in this little fatty coating called a lipid(*) bilayer(*), and that's just a technical way of getting the mRNA into your body without it being destroyed, because you need it to get into your body to make the protein of COVID, which isn't infectious, but that turns on the immune system to fight rule COVID when you do potentially encounter the virus. And so it just so happens that their recipe has a bit more material in it than the Pfizer recipe. But that doesn't mean it gives more side effects. The-
RAFAEL EPSTEIN:
[Interrupts} Oh no, I just was curious about why it's bigger. Yeah.
JOHN SKERRITT:
[Talks over][Indistinct] the side effect profile quite low. Well, it's just for the recipe that they've used to coat the messenger RNA so it isn't destroyed by the body. It's also a little bit different in terms of its storage and maybe that extra coating and so forth means it doesn't have to come out on dry ice. It can come out of freezer temperatures.
RAFAEL EPSTEIN:
[Talks over] No, it's a regular fridge. If I-
JOHN SKERRITT:
[Interrupts] Regular freezer. Yeah.
RAFAEL EPSTEIN:
If I can just go through a few other rapid questions. We don't get you too often in, but I know your time is short. Firstly, Novavax is the other big contributor to our vaccine effort. Is that going to be approved soon?
JOHN SKERRITT:
So, Novavax is being positioned very much as a booster type vaccine. We're sure, but we don't know whether it's sort of 12 months, 18 months or 24 month intervals. But we know that Australians, the same way we get our flu vaccine every year, we don't know whether it'll be every two years or every year or whatever for COVID. But Novavax is being positioned as a booster vaccine because it's often good to use a different vaccine as a booster, and its characteristics mean it'll be a pretty good booster from variants. We are still waiting on- we've got a lot of their data. We've been busy reviewing it, we're still waiting on some, but we may not get for a few more weeks, but we're confident that it will arrive by the end of the year when we need it, and potentially when doctors and government turn their eyes towards when certain Australians might need boosters.
RAFAEL EPSTEIN:
And I don't know if you know the answer, but there's some speculation that people might be getting Pfizer or Moderna as a booster, quote booster. Would they- would that have a separate application for approval to you? Or is the booster- is that word not really correct? You're just getting another dose of an already approved vaccine. Is it a different drug?
JOHN SKERRITT:
In a strict sense, they may want to come and modify their application, but it's not black and white. We'll obviously look at the efficacy of these products as boosters. And one of the big debates about boosters at the moment is whether you need to use a different vaccine with a different composition against variants. It's likely that people who may have had AstraZeneca will get Pfizer, Moderna or Novavax as a booster.
RAFAEL EPSTEIN:
Why do you think that's likely? I'm very keen to have one of each personally, because I've had AstraZeneca and I'd love one of the other. Why do you think that's likely?
JOHN SKERRITT:
I say likely, and it's nothing to do with adverse events. It's actually because of the- there's a little thing called an adenovirus vector that is in the AstraZeneca vaccines. And some of the experience overseas has been that if you keep on giving that same cocktail over and over again, the response isn't as strong. And you've actually got to go to something different to get a good booster response. But there's still a lot of work [indistinct].
RAFAEL EPSTEIN:
[Talks over] And would you need to approve- is that your job to approve someone like me getting a booster with an mRNA vaccine, or is that someone else's job?
JOHN SKERRITT:
It's a joint thing. So we certainly are there at the table. But the role of boost- of everyone now at ATAGI, which is- provides more specific and detailed clinical advice on, say, which groups are preferred for which vaccines. It may well be their recommendations on boosters that will emerge in the coming months. But we are at the meetings and we provide technical input. So while there's all these different organisations and committees and so forth, there's a pretty tight knit vaccine committee- sorry, vaccine community in Australia and everyone works together. We're too small a country not to do that.
RAFAEL EPSTEIN:
A personal reflection, professor, how do you feel about the way vaccines are now discussed because some people know heaps, others recycle misinformation. How does that make you feel?
JOHN SKERRITT:
Oh, look. We respect the fact that getting vaccinated is a- it's not mandatory in this country. It's an individual decision. I do, but- and, yes, there's still a lot of misinformation. And sadly, I get some days, dozens, other days, two or three, quite either poorly informed or frankly, abusive and threatening emails about vaccines. And that's just comes with the job. But it is- no one is mandating that people be vaccinated other than very narrow groups such as aged-care workers. And you can understand the reasons for that. But the average person on the street does not have a gun held to their head telling them they have to be vaccinated. But I think the tide has turned in that, whether it's Melbourne with lockdown number six or sadly, what's happening in Brisbane, or even a state like Queensland that have been pretty complacent because frankly, they've had a pretty good run. I think attitudes, there's been a wake-up call, if I could use a cliche, and attitudes to the vaccination are changing. And when you see that the line ups now in Sydney and so forth to go and get vaccinated, well, sure, it's under very challenging times, but at least people realise that if we're going to get back to anything that's vaguely like our lifestyle two years ago, and we're going to protect our friends, family and relatives and even people we've never met, getting vaccinated is absolutely central.
RAFAEL EPSTEIN:
Do you remember the first time you went to your local pool?
JOHN SKERRITT:
Oh, yes, I was warned about this. Yes. Now I'm- now I was originally a Sydney boy, even though I live between Canberra and Melbourne now, but I remember it well.
RAFAEL EPSTEIN:
Where was it? What suburb?
JOHN SKERRITT:
It was in the suburb of Epping and it was a pool called Dence Park. Now, the joke that was really funny to all the eight and nine year olds was that it was spelt the D-E-N-C-E, but everyone thought it was the D-E-N-S-E because of the little toddlers who forgot to go to the bathroom before they got in the pool and made the pool dense.
RAFAEL EPSTEIN:
That's quite disgusting, but a delightful note to end on. Thanks for your time.
JOHN SKERRITT:
Yes. Okay, thanks, Ralph.
RAFAEL EPSTEIN:
Professor John Skerritt, he's the head of the Therapeutic Goods Administration. As he mentioned, they're different to- you've probably heard of ATAGI, the Technical and Advisory Group on Immunisations. They're different, different group. They say Pfizer preferred under 60. AstraZeneca preferred over 60. Different group. The Therapeutic Goods Administration to say yes or no to every drug and medical device that comes into the country.
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