LUKE GRANT: Big news in the world of health in Australia, the national drug regulator, the Therapeutic Goods Administration has approved the Novavax vaccine as well as two oral treatments for vulnerable patients with COVID-19. I’ve been telling you about one of them, it comes from America, it's been really successful there. Not for everyone, but for some. On the line, the adjunct Professor John Skerritt, the head of the TGA. Professor, welcome to Drive, I hope you’re well.
JOHN SKERRITT: Yes, good afternoon Luke.
LUKE GRANT: Tell me about today's news. Novavax first off, it's been on the horizon for some time but it's been, is the term conditionally approved, today John?
JOHN SKERRITT: Provisionally approved. It means that, for example, we don't have evidence whether its duration of protection against COVID is six months, 12 months or five years. And so because of those sort of uncertainties, it's called provisional approval.
LUKE GRANT: Okay. So how soon, if you know the answer to this, perhaps it's in a different area, but have we got stocks of this to be rolled out now? Is that available for people or not?
JOHN SKERRITT: It has to come into Australia but today I've met with General Frewen, who manages the vaccine rollout, and also indeed with the Prime Minister and members of national cabinet. And we're expecting in the coming weeks, not-too-distant future that it'll land on our shores and be available through GPs and pharmacies who opt into providing Novavax.
LUKE GRANT: Right. And is there batch-testing when it comes here, it gets further tested, or once it’s here it can be given to people?
JOHN SKERRITT: Listeners can be confident the TGA actually tests every single batch of vaccine. And that doesn't matter whether it's this new one or whether it's Pfizer that we’ve now had for 12 months this coming week since it first arrived in Australia and was approved. So we test every batch of vaccine. It's a lot of work, but it basically- if anything, it holds it up by a couple of days because we put a big staff in who work long hours to test it.
LUKE GRANT: Gee, that's refreshing for listeners because I think John maybe unfairly, a lot of people think that that process can take weeks and weeks. So once you approve it which does take time, because you want to be sure, once you approve it, it's only each batch that you test for a couple days, and then it's available.
JOHN SKERRITT: Exactly. So the batch testing, obviously if there's a few funny results it might take three or four days but generally the batch testing takes two days or less. But it doesn't mean we cut corners, it just means that we literally run tests overnight, and we have a team of people working on each batch.
LUKE GRANT: Perhaps I should have asked you this as well at the beginning. When it's approved, that is a vaccine approved in the US and the UK, why don't we as some people have over the journey suggested, if they say it's okay, we say it's okay. What extra things do we do here?
JOHN SKERRITT: Well, we work very close with those countries. In fact, we talk to them almost every single day of the week. But every single country, every major country in the world makes its own independent decision and often it's because populations are different, the needs of that group. So for example, if a country has bought up a lot of vaccine and they want to target it towards, say, youth and people who are in the military, that might be different from the Australian situation. But the reason we've been able to approve these vaccines, is that we do so much of a work jointly with the other countries, but we reach our own independent decision. That also makes it easier because we have all the safety data, so if any problems arise we can tackle it earlier. And as listeners will know, sadly, there was a condition with the AstraZeneca vaccine. But we had far fewer people get seriously ill or dying from that in Australia because we had all the data at our fingertips.
LUKE GRANT: Yes, I think that was a bit to do with this is not a race, but that's a different conversation. Just on Novavax. I'm taking you everywhere John. I hope I'm not going to make it too hard for you, but I'm sure I'm not. But Novavax, is it a booster shot? Will it be offered for anyone not yet vaccinated? I guess there's two shots there, or even a smaller dose which children. Where are you on all of those?
JOHN SKERRITT: Well, we've always got to be responsive to what data we receive from the company and its trial. So the trials of the kiddies and also the trials of the boosters are still underway. But as soon as we get that data from Novavax we’ll look at it very quickly as a priority and reach a decision. But the current approval is for an initial vaccination. Now we've got a really good rate of vaccination now in Australia, but anything short of 100 per cent means that there are people who are very, very exposed. And for the unvaccinated, it's not just about them, it's about the little old lady they might stand behind in a supermarket queue. It might be their aunty, it might be their grandmother, it might be their children, it might be their friends.
LUKE GRANT: Yeah.
JOHN SKERRITT: So we've got 93 per cent almost over 16 years old double vaccinated in this country but it does mean there’s seven per cent who aren't. And even if, say, two per cent of that seven per cent are interested in taking Novavax, well that will continue our journey towards mastering COVID in this country.
LUKE GRANT: Yeah, got you. You also approved today Pfizer’s Paxlovid which I've read a bit about from America. And there's a Merck Sharp treatment as well. Can you tell me about those briefly?
JOHN SKERRITT: Okay, now about the two treatments, they’re the first two oral treatments for COVID. So to date, there have been some treatments that you can go to the hospital and get. But apart from the fact that our tremendously busy colleagues in the hospital system it means that they’ve got to put people in for putting it in an intravenous treatment in so it's takes nurse and doctor time. Plus, they’re complicated and very expensive. These two treatments can actually be used orally in the outpatient situation. So for example, they could be used in residential aged care, or they could be used at home by people who we want to stop- you know, if you have a serious respiratory or heart condition, and they're identified as high risk or they’re immunosuppressed, we want to stop them getting really ill and getting sick and potentially dying. So, these two drugs from the two different companies, they work different ways but they're both really useful additions to the current set of drugs we have in our fight against COVID.
LUKE GRANT: Right.
JOHN SKERRITT: And they're not a substitute for vaccination…
LUKE GRANT: Of course.
JOHN SKERRITT:…but they'll be an additional treatment for people who get ill, vaccinated or unvaccinated.
LUKE GRANT: And I assume it's the same thing. We've got to get supplies of these and you've got to batch test them. When will they be available for the doctors and the like to prescribe?
JOHN SKERRITT: Okay. Because they’re medicines, we don't have to batch test them because the way- the challenge with vaccines is it it’s very easy for a vaccine to not be the same as a previous batch. It's a bit like Grandma's Christmas cake. Medicines, on the other hand, unless if something goes terribly wrong, tend to be made much more consistently. So, we don't have to wait for these to be batch-testing. I can tell you that discussions with the company about putting these two medicines on aeroplanes to Australia in the coming days have been had, and I'm expecting them to turn up very soon.
LUKE GRANT: Outstanding. I'm speaking to Adjunct Professor John Skerritt, head of the TGA here in Australia. John, if I can just briefly ask you about rapid antigen your tests.
JOHN SKERRITT: Yeah, sure.
LUKE GRANT: I think you've- the TGA has approved 22. They're obviously in short supply and I know that-
JOHN SKERRITT: [Interrupts] 23.
LUKE GRANT: 23, yay. And I know there are-
JOHN SKERRITT: 23 ones for home use, Luke. We’ve also approved over 40 that can be used, for example, in aged care, in workplace situations. So, there's quite a large number approved. In fact, we've actually approved a wider number of these tests than the US has, speaking about other countries.
LUKE GRANT: That's intriguing. I didn't realise that. So we're certainly- in a comparative sense with America and other countries, we’re certainly not dragging the chain. But John, I have to tell you that there's been a couple of manufacturers and a couple of importers who have indicated to me in interviews up till this point that the process here in getting them approved is slow. You're the best person to respond to that. What do you think?
JOHN SKERRITT: Thank you asking that.
LUKE GRANT: It's a pleasure.
JOHN SKERRITT: Well it isn’t slow. If you give us all the data, we're doing them in 72 hours. I wouldn't call that slow when you-
LUKE GRANT: [Talks over] Hang on. Hang on. That's extraordinary. So if you've got all the data, you approve them in, what, three days?
JOHN SKERRITT: Three to five, but often towards the three, but we've got to get all the data. And what's really been, frankly, misleading, if you don't mind me saying that, Luke…
LUKE GRANT: No.
JOHN SKERRITT: …is a number of companies- it’s a bit like you need seven chapters of a book, and they’ve given us chapter 1 and 2 in November. And we said: sorry, you've got to give us the others. And it's clearly spelled out what the six or seven things they have to give us. And we wait and we wait and we wait. And in fact, without naming names, two of the companies that have been really noisy have actually asked us twice for extensions to give us that information. Now, you can imagine what that does to my blood pressure when I hear them on the radio or TV saying they're waiting on us. So, as soon as we get everything, it's a matter of days.
LUKE GRANT: John, I'm so glad we had this conversation.
JOHN SKERRITT: So am I.
LUKE GRANT: As a side comment, you would be the best person in the country to know the ideal medication for your blood pressure, just saying. But you’re right-
JOHN SKERRITT: [Talks over] Well, I’ve needed a lot of it. And look, I want to also say, you know…
LUKE GRANT: Yes.
JOHN SKERRITT: …public servants and bureaucrats get beaten up a lot. But I actually said to the team: look, sorry, guys, I know it's summer, but do you mind? Normally they take a week of their holidays between Christmas and new Year. I had them back here on Boxing Day. And I had people coming back from long service leave, you know, who had it planned for months and months, you know, long service leave…
LUKE GRANT: Yeah.
JOHN SKERRITT:…And they actually came back from a coast to help out. So, it's really frustrating when you hear people say: look, we're waiting on those guys for months. That's why we are turning around in a matter of few days because they're such a dedicated team.
LUKE GRANT: John, I'm so glad that we have the opportunity to said that straight. Thank you for all you're doing and your team. I don't think anyone has any doubt that you have everyone in Australia's best interests at heart. And to hear you calling staff back and depriving them, for now, because of the very important work you do, of those few days speaks volumes of all those people in health, not just doctors and nurses, the people working in your sector…
JOHN SKERRITT:Look, I know.
LUKE GRANT: …and we thank you for all you're doing.
JOHN SKERRITT: No, and look, it's not about me; it's about those colleagues. And I know I've taken away from their valuable family time, but I've got people here by the hundred who are just so committed, as other doctors and nurses, to beating COVID.
LUKE GRANT: Brilliant. Thanks.
JOHN SKERRITT: And they’re doing it by what we do, and they're so committed.
LUKE GRANT: Yeah. Hopefully we'll talk again, John. I really appreciate your time, and thank you for all that information. It’s so important. Thank you.
JOHN SKERRITT: Okay. Anytime, Luke.
LUKE GRANT: Good on you. Well, there he is, Professor John Skerritt, Adjunct Professor John Skerritt, the head of the TGA. He's ahead of the joint. Now, I’m going to tell you as a broadcaster, I’ve spoken to people who say the TGA’s too bloody slow, Luke. And I now have an opportunity to go back to them and say: have you given them chapters 1, 2 and 3? And where are the others? Or is- you know, we can work through this. They’re approving these things in three days. Wow. A really important conversation.
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