Therapeutic Goods Administration Adj. Professor John Skerritt's interview on Sky News First Edition on 10 August 2021

Read the transcript of Therapeutic Goods Administration Adj. Professor interview on Sky News First Edition on 10 August 2021 about COVID-19 vaccines.

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PETER STEFANOVIC:           

The Moderna vaccine has been given the green light by the nation's medicines regulator, opening the door for the vaccine's use by September. Joining me live now is Professor John Skerritt from the Therapeutic Goods Administration. Professor, thanks for your time this morning.

As we know, Moderna had been approved in the US last December, it was approved in the UK in January. It's now August here. What took us so long?

JOHN SKERRITT:                  

Well, it didn't take us very long at all. In fact, this is the fastest vaccine approval we've ever done. We only received a complete application last month, on the 8th of July. So, we approved it in 32 calendar days. Now, the fact is we were able to do it so fast because we did work closely with the other countries, including on their real-world experience with the vaccine. But it's the fastest approval we've ever done.

PETER STEFANOVIC:           

Yeah. But why, but why that delay? Why so far behind the US and the UK? Was- is that a problem with the order itself, not so much your okay?

JOHN SKERRITT:                  

Not so much with the ordering. It's a commercial decision from Moderna when they put the application in. And they were basically flat out with their applications in other countries and so, we only got the complete application in July. But we have benefitted from the real-world experience when it comes to safety and efficacy from other countries.

PETER STEFANOVIC:           

And how does it compare to, you know, your AstraZenecas and your Pfizers that are in play here?

JOHN SKERRITT:                 

Well, it's a similar vaccine to Pfizer. It was developed totally independently of Pfizer and you always get greater confidence in science and medicine when two totally separate developments can yield a very successful result. So, it's a messenger RNA vaccine, doesn't change your genes or anything like that. But after vaccination, it produces a non-infectious form of the protein that has triggered COVID. And that protein, actually, the body makes an immune response to and therefore, if you are exposed to COVID, you get protection. So, it's very similar in terms of how it works to Pfizer, but it was developed independently by a different company.

PETER STEFANOVIC:           

And how well does it protect against Delta and other mutant strains?

JOHN SKERRITT:                  

The data looks good. There seems to be a good level of protection against the other strains. Having said that, both Moderna and a number of the other companies are developing variant-specific vaccines to make sure that as these variants evolve, that we're still well protected. But one of the really exciting things about Moderna is they have six months' experience on real-world protection and it seems to be 93 per cent against getting infected. But more importantly, 98 to 100 per cent against getting hospitalised or dying. So, that's really good news. Six months out from being vaccinated, but you're still very protected.

PETER STEFANOVIC:           

And do you think it's likely that Moderna wanting to test its vaccine on babies as young as six months here, it will eventually happen in Australia. Do you have a timeframe on when that is likely to be approved?

JOHN SKERRITT:                  

Look, Moderna made a broad announcement that they are looking at doing this and many companies are testing in babies and young children. Now, obviously safety is paramount as soon as you test a medicine or a vaccine. But a lot of vaccines are tested in babies and young children, particularly flu vaccines. For many years, there's been trials of flu vaccines in babies and young children.

We don't know whether they want to do trials in Australia. We haven't had an application from them yet. And if they do, obviously we'll talk about with them about all the safety controls. But it may well be they run these trials in the US and work together with our colleagues at the US FDA.

PETER STEFANOVIC:           

Okay. So even if that happens, it could be a long way off. Just finally, Professor, rapid antigen testing, when -again, the question of timelines, when do you think this could be available in homes?

JOHN SKERRITT:                  

So, at the moment, there's a number of companies both in aged care and the Commonwealth Bank and a number of other businesses, including mining, fly in, fly out workers, they're using rapid antigen testing. But they're doing it under supervision because it's really important that you take a good sample. We all know those of us who have had COVID tests that it's not very pleasant. And so, the risk of taking a sample that isn't as good as you need to to actually get the virus where it is, the risk of interpreting the test results incorrectly and most importantly, the risk of the data not going into a central system.

If you have a PCR test at the moment - and my spouse, for example, had one last week, it goes immediately into a state or territory system and you're notified, positive or negative. There isn't a system built yet for these rapid antigen tests for immediate notification. So, we're working over coming months with the governments, we're working with the companies who actually have commercialised these tests. There's 23 of them available already and many of them in use, to enable their wider use, for example, potentially in pharmacies and at home. But there have to be a few systems built first.

PETER STEFANOVIC:           

And so, we're deep into next year, I'm guessing, here?

JOHN SKERRITT:                  

I really don't know. It could be the end of this year. I mean, things are moving fast and our team is working very hard. What we have stood up is a team to advise and assist anyone, for example, a company or if it's a travel organisation or an airline or a bus company or whatever. Anyone who wants to use these tests, with the current rules and guidelines, we're happy to support them as are some of the business groups in Australia, because rapid testing isn't a replacement for PCR testing, but it's a useful adjunct to it. And we do want testing to be as broad as possible, but it also has to be reliable.

PETER STEFANOVIC:           

Yeah, I mean, I would have just thought it'd be handy to have one at home like they do in America. If you wake up one morning and you're feeling not too bad, you've got a slight sniffle, you know, and do it yourself, I would have thought that that would be okay.

JOHN SKERRITT:                  

Yeah, yeah. But, as I said, the challenges we have in Australia are these tests aren't as reliable. So, they give you false positive and false negative answers. And we have to have a way of managing that, let's say you get a positive test, you're immediately taken off to have a PCR test, the gold standard, reliable test, or if you get a negative test, the message is clear that that doesn't mean you're negative forever.

And so, it's really building the systems. And the difference between Australia and the UK and the US is that even in places like western Sydney, the prevalence of COVID, thank God, is so much lower. And especially when the prevalence is lower, the reliability of these tests does go down.

PETER STEFANOVIC:           

Okay. Professor John Skerritt, we're out of time, but appreciate your time this morning. Talk to you again soon.

JOHN SKERRITT:                  

Thank you very much.

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