Therapeutic Goods Administration Adj, Professor John Skerritt interview on ABC Radio National on 2 December 2020

Read the transcript of Adj, Professor John Skerritt interview on ABC Radio National on 2 December 2020 about coronavirus (COVID-19)

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FRAN KELLY:

Hopes are rising that COVID-19 vaccines could be available in both the UK and the US before Christmas. In fact, Britain's talking about rolling theirs out from Monday. Vaccine maker Moderna is applying to US and European regulators for emergency rollouts to start within weeks, while Pfizer has already announced that its seeking fast track approvals for its own vaccine. America's infectious diseases expert, Dr Anthony Fauci, says these vaccines are safe and they work.

ANTHONY FAUCI:

The efficacy has been stunningly good. And when I see stunningly good, I mean, none of us would have expected to have seen a 94, 95 per cent efficacious vaccine with no significant severe adverse events.

FRAN KELLY:

Seal of approval there from Dr Anthony Fauci, the Director of the US National Institute of Allergy and Infectious Diseases. Here at home, progress is being made too, with the Therapeutic Goods Administration. The TGA giving the go ahead for two vaccine makers to apply for provisional approval here in Australia. Adjunct Professor John Skerritt is the Health Department's Deputy Secretary responsible for the TGA. John Skerritt, welcome to Breakfast.

JOHN SKERRITT:

Good morning, Fran.

FRAN KELLY:

The TGA has cleared the way for both the AstraZeneca and the Pfizer vaccines to apply for provisional approval. How soon could that- does that mean they could be rolled out?

JOHN SKERRITT:

Well, Fran, we actually have a third vaccine that we've given provisional determination to, from Janssen. So there's actually three candidates now. It will depend when we get all the data from them. But we're still very hopeful that vaccines will be able to be rolled out in Australia by the end of the first quarter in 2021.

FRAN KELLY:

Okay. When we talk about applying for provisional approval, what has to happen? What does the TGA have to be satisfied with before it gives it the all clear?

JOHN SKERRITT:

Well, it's the entirety of the evidence. So it's the safety, whether it works. In other words, whether it's efficacious, and also if it's manufactured consistently and to high quality. And we are still to receive a full clinical data from any of these companies, but we have interim data from each of them. And as Dr Fauci said, it's looking very promising.

FRAN KELLY:

Okay. But it's looking so promising that the US and Britain want to start vaccinating within days and weeks. And yet you're saying it’s likely to be March for Australians. Why?

JOHN SKERRITT:

I'm saying our approval will come either late January or February. It reflects the differences between the countries. They're not approvals of those two countries are talking about, they’re emergency use authorisations. And they're based- and they're really reflecting the desperate situation of those countries. We have to remember that on many days, day after day, the US is having more deaths than we've had in the whole year of a pandemic here in Australia. So it reflects the desperate situation of those countries. And these authorisations require the delivery of a vaccine to be very tightly and closely monitored. In Australia, we want to be able to give a approval to the vaccine so they can be used throughout the country through distribution in partnership with the states and territories.

FRAN KELLY:

Okay. So you want all the data, the US and the UK happy to go on interim data because basically they're desperate, they need to get going. Are you happy - as happy as Dr Fauci there, who describe the Pfizer and Moderna jabs as stunningly good - are you happy with what you've seen in terms of efficacy and safety? Do you have any questions?

JOHN SKERRITT:

We have certainly been impressed with the efficacy data. Now, efficacy is only one thing. One of the other big questions that no one has the answers to is whether these vaccines have a duration of six months, a year, five years, forever. And we'll have a better idea the longer we go with just how long protection is. But the efficacy data has been impressive, especially because these are new technologies.

FRAN KELLY:

But we won't be able to know how long the immunisation lasts, the protection lasts, or which lasts longer, which is better in those terms until we start rolling them out for some years, is that what you’re saying?

JOHN SKERRITT:

Exactly. And that's why Australia and most other countries have invested in several vaccine candidates. And that's also why there's another group of second and third generation vaccines already being developed. We've talked to over a dozen countries- a dozen companies who have developed a vaccine.

FRAN KELLY:

The AstraZeneca one was the first one that Australia said it's investing in, it’s the one in conjunction with Oxford Uni. And we've bought, I think is it 30 million jabs, I haven’t got that number quite to hand, but I think ...

JOHN SKERRITT:

We're manufacturing 30 million locally and we're importing almost four million.

FRAN KELLY:

Okay. Last week, when AstraZeneca announced their results so far, they said the vaccine was up to 90 per cent effective. But it's later become clear and acknowledged by AstraZeneca that that efficacy rate was when participants were given an initial half dose, followed by a full dose, which was actually by mistake and it was a small group. Are you concerned about that, that this information was presented in that way? Does that give you second thoughts or any doubts about the AstraZeneca jab and also about the effectiveness in comparison to the Pfizer and Moderna one?

JOHN SKERRITT:

Well, first of all, we saw the data, the two groups of people, and it's not unusual that paradoxically, a lower dose of a vaccine could be more effective. We've seen this with some of the other ten companies who have confidentially shared information with us - 90 per cent is higher than 60 per cent, obviously, but what will be of interest to us will be the protection in different groups of people. So, for example, it may be that for the elderly or for young frontline health care workers the protection is higher, or it may be a vaccine that is better at reducing transmission. And so, it’s all these things, not just one magic number, that is important to regulators.

FRAN KELLY:

So, the data you’re looking at from Pfizer, from Moderna, from AstraZeneca, is that test- is that telling you the results per group? Per age group, for instance?

JOHN SKERRITT:

In many cases they have what they call stratified the results by age group. One of the things that most companies have done with vaccine trials for COVID vaccines has tested a large number of older people, given they’re particularly susceptible to dying from the condition. But generally, we will look at the data for different age groups where it’s available, and that will affect what recommendations and approvals we give. So, if for example there’s no data for under-18s, we may not approve the vaccine for under-18s.

JOHN SKERRITT:

Explaining confidence in vaccines in what we do and what we don't know, and being transparent will be very important. We've seen that data; we were aware from the very outset that they got different results in the two groups of patients. We have not yet got the detailed information; we will get that in the coming weeks from AstraZeneca and our doctors and scientists will examine that data in detail. But we were aware from the outset that they were getting a different result with those two parts of the trial.

FRAN KELLY:

Okay. Could it give- make a rethink for the TGA in terms of the provisional determination?

JOHN SKERRITT:

No, it wouldn't make a rethink. As I said, we will look at…

FRAN KELLY:

[Talks Over] Why not?

JOHN SKERRITT:

Well, we will look at the data as we get it. And as I’ve said, a 60 per cent efficacy may still be very valuable in large groups of people. There, there are really three things that are important with any vaccine; its efficacy; its duration of protection; and obviously, the number of people who go and get vaccinated - they’re the three things that contribute to what we call herd immunity.

FRAN KELLY:

And just to be clear, the vaccines we're talking about, they are, as far as we know, the efficacy we're measuring is in terms of stopping people getting very sick – it's not stopping people being infectious, is it?

JOHN SKERRITT:

So, they're the headline data. And of course what we, as regulators, want to see is a more detailed scientific data which does pick up on the second thing. So, there's a whole lot of different measures. You could look at people not getting detectable infection, you could look at people not transmitting infection, you could also look at whether a vaccine stops asymptomatic people transmitting infection. They're all the sorts of things that, as we sit down and spend hours and days and weeks pouring over that data, that we'll work closely with the companies on. What we're getting at the moment from all the companies are very brief summaries by press release. But of course, there's tens of thousands of pages of information on each of these products that we will be reviewing.

FRAN KELLY:

Getting the vaccine approved is one thing, the rolling it out is another. How advanced are the plans to administer this vaccine across the country?

JOHN SKERRITT:

Quite advanced. Now, that will be in the hands of the Prime Minister and the Minister to announce the details. But as the Department of Health we've been working very closely, not only with the commercial sector, but with the states and territories. In fact, we recently stood up a whole divisional unit of the Health Department just to focus on the rollout of COVID vaccines. So, it’ll obviously depend which vaccine – we've heard already, for example, that the Pfizer vaccine requires dry ice storage, that's a very different situation from other vaccines that can be handled in a normal refrigerator situation. So-

FRAN KELLY:

[Talks over] And perhaps particularly problematic for a country like Australia, which has such vast distances and such hot temperatures at times?

JOHN SKERRITT:

Although, the dry ice storage is very technically advanced and, especially with the opening up of flights between states, it's possible to get things, you know, across the country within a day or so. And these dry ice storages can be replenished a couple of times.

FRAN KELLY:

Just finally and briefly, John, how long will it take, do you assess, to vaccinate the whole country?

JOHN SKERRITT:

The Government is talking about a, a need to get the country vaccinated through the course of calendar 2021 - obviously starting with priority groups such as health care workers and the old, and people who have other related illnesses.

FRAN KELLY:

And do you expect then that the ones we go with will be double jabs?

JOHN SKERRITT:

Most of the vaccines to date are being promoted as double jabs and that will be important - making sure that people do also follow up and have the second jab. And so, that will be part of the rollout conditions in order to monitor people that they come back either three or four weeks later, depending on the vaccine, for the second jab.

FRAN KELLY:

Yeah. It needs quite a sophisticated public health campaign, doesn't it?

JOHN SKERRITT:

[Talks over] It is, yeah.

FRAN KELLY:

John Skerritt, thank you very much for joining us and filling us in. And good luck with what's ahead.

JOHN SKERRITT:

Thanks very much, Fran. It's a huge challenge.

FRAN KELLY:

It certainly is. John Skerritt is Adjunct Professor and Deputy Secretary for Health Products Regulation at the Department of Health, Head of the Therapeutic Goods Association, the TGA.  

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