Therapeutic Goods Administration Adj. Professor John Skerritt's interview on ABC Radio Melbourne on 20 January 2022

Read the transcript of Therapeutic Goods Administration Adj. Professor John Skerritt's interview on ABC Radio Melbourne on 20 January 2022.

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RAFAEL EPSTEIN: The Head of the Therapeutic Goods Administration, the TGA, is Professor John Skerritt. Good afternoon.

JOHN SKERRITT: Yes, good afternoon, Raf.

RAFAEL EPSTEIN: What precise use has Novavax been approved for?

JOHN SKERRITT: So Novavax has been approved, the same way as the other COVID vaccines, for vaccinating adults over 18. So the standard two courses of vaccination for prevention of COVID infection.

RAFAEL EPSTEIN: And why not for a booster or for kids yet?

JOHN SKERRIITT: Essentially, because they haven't applied for it. They're still gathering data on its use as a booster. There's been a few academic studies. And similarly, there are trials in kids, adolescents, and so forth, are still underway. But they have indicated that in the coming month or two, they will be applying for those users as well.

RAFAEL EPSTEIN: So you can't get it for a booster yet?

JOHN SKERRITT: No, because they haven't applied and the data is still being put together.

RAFAEL EPSTEIN: Novavax is, for reasons that I don't understand, the anti-vaxxer’s vaccination of choice. Do you get many emails about it?

JOHN SKERRITT: Oh, boy, do I. I've probably had a couple of hundred. And look, the rationale is that it is produced from- well, it is a protein-based vaccine, which is a longer standing technology. It’s still a vaccine that’s produced through biotechnology. It's produced by genetic engineering, and it's manufactured in insect cells. So it's not exactly something that you're directly taking from nature. But it is a protein technology, which has been around for a few more years.

RAFAEL EPSTEIN: [Interrupts] So it's an older technology, isn't it?

JOHN SKERRITT: It's an older technology, yes. And so maybe that's why some people feel, well, the technology has been around longer. But I would say that we've had many billions of AstraZeneca and messenger RNA vaccines administered globally now. I think we're up to over 9 billion I think 9.5 billion COVID vaccinations globally. So that's a very large amount of global experience with these newer technologies.

RAFAEL EPSTEIN: And just to spell it out, Professor Skerritt, the data you look at and whether or not it is safe, you’ve run the same ruler over Novavax you have over Pfizer, Moderna, and AstraZeneca?

JOHN SKERRITT: Yes. In fact, some would say we ran even a bigger ruler over. We took longer to approve Novavax, because they transferred their manufacturing site to what is the world's biggest vaccine manufacturing company, in the Serum Institute of India. But because they move the manufacturing site, we actually had to do a lot of work to make sure the vaccine made at the Serum Institute was all the same, for all intents and purposes, as the original vaccine made in the US, so...

RAFAEL EPSTEIN: [Interrupts] Right. So this is the reason a whole lot of countries have been slow with Novavax, because they shifted their base of manufacture?

JOHN SKERRITT: Yeah, so Novavax are a small company. Whereas you look at some of the drug companies that have things like AstraZeneca and Pfizer, they’ve been around for decades. In fact, some of those companies have roots almost a century old, maybe under different names. Whereas Novavax is quite a new company. This is one of their very first products to market. And so they had to establish partnerships for making many millions, in fact, billions of doses. And so they've had to form manufacturing partnerships across the world.

RAFAEL EPSTEIN: Professor John Skerritt is the Head of the Therapeutic Goods Administration, 1300-222-774 is the talkback phone number, of course. Professor Skerritt, that last – I don't know what it is – five per cent of adults who haven't had a jab, do you think it's going to come down a lot because of Novavax being approved?

JOHN SKERRITT: Look, it’s hard to tell. We’re at 95 per cent who have had a first vaccination, and that's absolutely fantastic. And I was with the Prime Minister and Premiers today at National Cabinet, and I think we're number was 93 nationally, we're up to for two doses. Now, of course, we're encouraging people to have a booster dose, especially with the Omicron variant. But we are told that- and we don't know whether it's an extra one per cent, an extra 0.5 percent. But even if we went from 93 per cent to 94 and 95 per cent fully vaccinated, when you think about it the other way, that's going from 7 per cent down to four or five, or even six per cent who are unvaccinated. And the lower we can get that unvaccinated figure, the better, not only for those folks, but also for their family, relatives, and friends.

RAFAEL EPSTEIN:  The massive supply chain issues that we now have with rapid antigen tests, your organisation only approved them for use, I think, from 1 November, early November. Anyway, could that have happened more quickly?

JOHN SKERRITT: It could have if it was the right thing to do, but it wasn't at the stage. So let me explain. We approved rapid antigen tests, the ones for supervised use, in particular situations, such as nursing homes and so forth, almost a year earlier than that. And so there were a lot of rapid antigen…

RAFAEL EPSTEIN: [Interrupts] That’s if a doctor or qualified persons using.

JOHN SKERRITT: Or, say, someone supervising a nursing home. But the ones for home use, we only put the information out in September, and they were able to be used from 1 November. But there's a very good reason why that was quite deliberate. And the reason is that home tests, rapid engine test for COVID, do not work well when you have a low amount of disease and you're wanting to do individual contact tracing. And Australia is not doing that now. Sadly, we've got much higher levels of disease. And apart from Western Australia, we’re no longer doing individual contact raising. You just couldn't with the sheer numbers of cases. Why is that so? And it's a little bit statistical-technical, but effectively, when you don't have much disease in Australia, compared with say the other countries, you get a very large number of false positives. Even every second test can give you the wrong results.

RAFAEL EPSTEIN: [Interrupts] Sure. Can I interrupt, Professor? Only because if had approved them earlier, maybe we could have ordered them earlier. If we'd ordered them earlier, we'd have more. There's no regret about not approving them earlier?

JOHN SKERRITT: Well, as I said, we provided guidance that the approvals would start during October, to be effective from 1 November. Actually, during the month of November, there was – it sounds amazing to say this now – there was a surplus of rapid antigen test. So there were some pharmacies and so forth that were even putting them on sale, because they actually weren't selling very well. Now, no one knew about Omicron coming along. 1 November, no one has heard of Omicron. It was a first [indistinct]…

RAFAEL EPSTEIN: [Interrupts] But a lot of people were warning we’d need more of them. The AMA and the aged care industry, they were saying, before you approve them, we need more of them.

JOHN SKERRITT: And so there were companies that were obviously responding to the demand, and some had more than others. But our role, at least from the TGA, wasn't in terms of ordering volumes. The other thing I'd emphasise is we've actually approved more rapid antigen test from the US FDA, even though they’re the world's biggest regulator. We actually have now approved 23 home tests, and I think 43 point of care test, the ones I was talking about that nursing homes and so forth can use. So in the US for example, it's only, I think about 15, 16, 17. So we've actually approved more tests here in Australia than the Americans. And I think we've approved twice as many as the Canadians.

RAFAEL EPSTEIN: 0437-774-774 is the text message number. I'll get to those texts soon. Professor Skerritt’s the Head of the Therapeutic Goods Administration. They approve drugs and medical devices that are approved for use in this country. Professor, I think you said just before, but when we don't have much disease, every second RAT test gives you the wrong result.


RAFAEL EPSTEIN: Do you think we're still getting a lot of incorrect results?

JOHN SKERRITT: No, I think - so there's two types of incorrect results you can get with a test. You can get a false positive where you and the people around you, and the system thinks that you're with COVID, that you're infected. Now when there's not many infections around, such as for most of last year, and even at the peak of infections, and I say this as a Victorian, even at the peak of infections, by global standards, even Melbourne had a lower rate of cases. Not so now, but when we were having a couple hundred a day, by global standards, that was small all for a city of several million. And so when you've only got a couple hundred cases a day, every second positive test is actually a false positive. However, when you start to have a situation when you've got over 1000, and maybe even over 10,000 a day in a city, and getting up to 50,000 to 100,000 in the country, you can be pretty sure that 99 per cent of those tests, if they're positive, they're genuinely positive, and you have COVID. And that actually makes the use of rapid test totally different, and that's why we're fully behind rapid test being used to screen for COVID for diagnosing the disease. That wouldn't have worked a year ago, or even six months ago, or even at the beginning of November, but it does work now. They do give some false negative results if in the very early stages of infection [indistinct]…

RAFAEL EPSTEIN: [Interrupts] Well, very early on and very late on, too, isn't it? Like if you had it at seven days ago or something, you cannot pick it up.

JOHN SKERRITT: Late on is not as important for infecting others, because it's at the early stages where you may get the infection and infect others, but the rapid tests. So the message is if you are symptomatic, often you'll still be encouraged to go and have that PCR test, just to be sure.

RAFAEL EPSTEIN: And why'd you put that ranking of the RAT test on your TGA website? What's that for? How should people use that?

JOHN SKERRITT: Well, it's based on - at the moment, again, I'd say any RAT test that's approved by TGA is worthwhile using. But we have data which shows that they perform differently, that some of them are more sensitive than others. And so they’re all- they all have passed muster. We wouldn't approve them if they weren't sensitive enough. But some are very high sensitive, sensitivity, and some are high sensitivity, and others are acceptable sensitivity. So that's why we put the three groups of them in the interest of transparency. But we would encourage people, especially at the moment, that any of the RAT tests will be suitable. It's just the very high sensitivity ones will perhaps detect the disease earlier on.

RAFAEL EPSTEIN: And if you could actually buy one – though I don't know anybody who can – but if you could buy one, which brand would you buy?

JOHN SKERRITT: I'm not going to advocate brands, but I will mention that in Sandringham and in Brighton last weekend, we were able to buy rapid antigen tests, lining up like everyone else.

RAFAEL EPSTEIN: [Interrupts] Alright. Chemist or supermarket? What was it?

JOHN SKERRITT: I won’t mention the names of businesses. One was a supermarket, but one was a pharmacy.

RAFAEL EPSTEIN: There you go.

JOHN SKERRITT: So twice on Saturday, we were able to buy some RAT tests.

RAFAEL EPSTEIN: How many of you got at home?

JOHN SKERRIT: Four [laughs].

RAFAEL EPSTEIN: Yeah, right. It’s okay, that’s not bad. That's not bad, doing better than most. Thanks so much for your time and for your work.

JOHN SKERRITT: Okay, Thanks very much, Raf.

RAFAEL EPSTEIN: Professor John Skerritt’s the Head of the Therapeutic Goods Administration.


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