RICHARD GLOVER:
Well, in the UK, an ebullient Boris Johnson has been declaring the beginning of the end to the COVID crisis, announcing emergency use approval of the Pfizer vaccine, with the first jabs being given as early as next week.
[EXCERPT]
BORIS JOHNSON:
They’ve used the virus itself to perform a kind of biological jujitsu to turn the virus on itself in the form of a vaccine in an idea that I think was pioneered in this country by Edward Jenner in 1796.
[END EXCERPT]
RICHARD GLOVER:
There you go, Boris Johnson being very Boris Johnson. In America, there's also talk of an early rollout as the number of infections and deaths continues its sharp increase in that country. So, what's the process here? And what's the difference between this emergency use approval that the British have given and the sort of full-on approval that we are looking at? John Skerritt is Deputy Secretary at the Department of Health and the person responsible for the Therapeutic Goods Administration, who get to- the ruler over these vaccine candidates. And John joins us on the line. John, good afternoon.
JOHN SKERRITT:
Yes, good afternoon, Richard.
RICHARD GLOVER:
When we say it's been given emergency authorisation in the UK, what does that mean?
JOHN SKERRITT:
Well, it's just that. It reflects the fact that sadly, in the UK, every day, they have… well, in two days, they have as many people diagnosed with COVID as we've had the whole year, and they've had over 59,000 deaths compared with 908 I think the latest number is in Australia. So the situation in the UK and of course, in the US are much, much- sadly more dire than we have in Australia. So what they've done is realise that they only have incomplete data and that's why it's called an emergency use authorisation. But given the seriousness of the situation there, they're going to allow its limited use in aged care homes under very close supervision and with many pages of rules and guidelines as to how it will be used. They do plan to do what Australia does and actually look at a full approval in the coming month or two or three.
RICHARD GLOVER:
So- it's under- from your scientific mind, it's understandable that they've done this early approval, this emergency approval, with all the conditions that you mentioned while we are holding on. Both the speed- the differential speed is understandable given the situation. Is that what you're saying?
JOHN SKERRITT:
That's what I'm saying, that they are in an emergency situation with their massive numbers, as is the US, and that's why they’ve made the decision to take what is a greater risk to go earlier when there isn't as much safety data and there's not as much known about how well or how long these vaccines work in different groups of people. But if Australia is in the same situation, it may well have been a decision that our government would have made, too.
RICHARD GLOVER:
Okay. So, a reasonable risk, but one which we're not forced to take, thank goodness.
JOHN SKERRITT:
One we're not forced to take, thank goodness. So by the time that we will be receiving more data and over the period of December and January, looking at that data- we've started to look at the data already, I should say. So, we've had data for several weeks now, incomplete data. But when we get more data, we'll know more about the safety, how well it works, what populations, does it stop transmission versus reduce the symptoms and severity of disease. But these are all the things that have to be looked at. How well is it manufactured? And can you make it the same way at the same quality every time? Who should it- who is it most effective with? These are all the things that tens of thousands of pages of documentation will reveal over the next few weeks and between now and late January, early February, we hope.
RICHARD GLOVER:
And of course, it’s not only one it, is it? There’s the Pfizer vaccine but there's about four others that you're looking at pretty seriously.
JOHN SKERRITT:
Exactly. Well, we're currently looking at three, but we've had discussions with over a dozen other vaccine developers who are at early stages of development. And first of all, this was done to spread the risk when we didn't know whether these vaccines would even work at all. Now we've got promising results that suggests they- that so far, all the ones that have reported are working and that's beyond our wildest expectations. But we still don't know whether one vaccine might give lifelong protection, whereas another one might only give a year or two. And we also don't know whether, for example, certain vaccines are more suitable for pregnant women.
RICHARD GLOVER:
Could it be, in the end when March or April rolls around and there's vaccines available, that individual strands will be able to choose? Someone might say: look, I'd like the Pfizer vaccine. Others might say: well, that RNA technology they're using is a little bit newer, so I’ll go for the Oxford vaccine. Would that be available to people?
JOHN SKERRITT:
Look, that'll be a matter of the policy that individual states and territories will work with. And again, we haven't got full data from any individual company yet. And so, I was asked earlier today which one of the three or four will come through first, and I said: it's like watching the Melbourne Cup after the first 100 yards, you don't know. So, it'll depend whether we have one, two, three or four vaccines available. But it will also depend on the best medical advice. If, for example, one vaccine is a lot better for young, generally fit health workers in preventing spread and another vaccine seems to be a lot better in preventing elderly people get very sick and or dying, then in a way, the medical advice might steer people towards different vaccines.
RICHARD GLOVER:
There's also the issue, isn't there, that the Pfizer vaccine, even though the results are very good – and this is the one that Boris Johnson is talking about – it does require transportation at low temperatures, which might make it more complex to roll out.
JOHN SKERRITT:
Yeah, it’s is another factor. I mean, Australians are very familiar with Eskies and these are Eskies at dry ice temperatures. So, it does have additional issues with rolling it out. It doesn't make its use in rural areas impossible, but it is an added complication over some of the others. And like many things in the world, there are advantages and disadvantages with each of these vaccines.
RICHARD GLOVER:
John Skerritt is here, Deputy Secretary of the Department of Health, responsible for the TGA. John, when we were talking to people like you, scientists like you at the beginning of the pandemic, a lot of people were cautioning us and saying: look, don't get above your- ahead yourself. It might take years to get a vaccine. Maybe we'll never get a vaccine. Have you been surprised by the idea that in early December, or middle December, there'll be people in the UK rolling their sleeves up?
JOHN SKERRITT:
It is beyond many people's expectations. And where scientists and companies have been remarkably lucky and also clever is that most of the vaccines are based around a particular part of a virus called the spike, the spike protein or the genes that make the spike. And it happens to be, but that was a very clever decision to target the vaccines, because the vaccines that work on this spike seem to be working. But the other thing, of course, is just the sheer amount of money that's gone into this, the billions and billions of dollars. I don't know of any other medical endeavour that has ever had such a huge dollar investment. And what that’s been able to do is for companies, underwritten by government, to be able to do several steps of a process at once. Normally, they do one step, see if it works, before they spend another 20 or 50 million dollars. Governments worldwide have underwritten the risk of doing several things at once. And when you do five things in parallel rather than sequentially, that's why these vaccines have come to the market so much quicker.
RICHARD GLOVER:
Yes, it's great I mean, assuming it all works out, it's a great triumph for science, isn't it? John Skerritt…
JOHN SKERRITT:
[Interrupts] Well, let’s wait and see.
RICHARD GLOVER:
Yeah. Let's wait and see. Can you run us through the timing? So, we've got people rolling up their sleeves, as I say, in Britain perhaps next week. We'll get that data as it comes in in December, and I suppose in early January. Does it really it- will it really take until March for us to be getting a vaccine that people in Britain are getting pretty much now?
JOHN SKERRITT:
Well, we've got to see whether it's as good as its claiming to be. As I said, the British are taking quite an understandable decision to go with less data than we will have. So by, say, late January, early February, we'll actually have a lot more data than the British have now. So, we'll also see not only how well it's worked for five, six, seven, eight months after the first people were injected with it instead of three or four months, but we'll also have greater data on if there's any safety issues. So, for example, it shouldn't be used with people with multiple sclerosis or certain diseases. And we'll also know a lot more about how long the effect of the vaccine lasts. And so, by getting more complete data, because of the very lucky situation Australia is in as a country, means that we'll be able to target its use better. And of course, the date that TGA will be able to make a decision depends on when we get this complete data, but we're still on track for a decision to be made in very early 2021.
RICHARD GLOVER:
By which you mean maybe the end of February?
JOHN SKERRITT:
Well, it will depend. It could be the end of January. It could be end of February. A lot will depend on when we get some of this more complete data. But very soon after, we will make our decision. The Government will commence rolling it out. And Government has used the term March, but of course, there are steps that have to happen. And that's a similar timeframe for a rollout in a lot of the rest of the world. And again, we want to make sure that the rollout of this vaccine is a success and we know as much as possible about who it works best in, for example, before it's rolled out. And in Australia, we are- while everyone wants the economy to open up and travel and all those sorts of things, we're in a very fortunate situation to be able to actually have the time, a few more weeks to look at that data.
RICHARD GLOVER:
Okay, so a balancing act between, yes, our desire to open up on one hand, but every week you wait, you get a bit more data, and that's a good thing in terms of the successful rollout.
JOHN SKERRITT:
Yes. And Richard, I should also add that it doesn't stop even when the first person is vaccinated. One of the important roles that we will have, together with the health care fraternity and together with individuals who are vaccinated, is keeping an eye on any untoward adverse events. As a vaccine is rolled out, we'll know more about how long lasting the effects are and whether there are better vaccines, as we talked about earlier, for different groups of patients. And so, we will be monitoring this vaccine for as long as it's on the market. We've got vaccines in Australia that have been on the market for 50 years and we're still monitoring the safety and performance.
RICHARD GLOVER:
And just finally, I know this is not particularly a TGA decision, but obviously they'll have to be a queue, an orderly queue formed. I noticed in Britain, number one is the nursing home residents and their carers. They'll be absolutely front of the pack for the vaccine next week, says Boris Johnson. The Government will organise that sort of hierarchy here, too, I suppose.
JOHN SKERRITT:
Yeah. So the Government, the Cabinet, and also the National Cabinet through the Prime Minister, did announce, not surprisingly, that aged care workers, frontline health care workers are the top priority for vaccination. The Government is still considering, I guess, what is the relevant priority for other groups of people. And that will also be interacted with who the vaccines work best in.
RICHARD GLOVER:
All right. So, o’ lucky country that not only have, you know, staring down the- for the most part, staring down COVID, has not only been great in itself, it's also afforded us this opportunity to wait a little bit before we take- before we approve the vaccine.
JOHN SKERRITT:
Well, wait is one word. We're actually very busy waiting. I made a comment today at another interview that sadly, most of us won't be on the beach this summer. We'll be working away and we'll be looking at a lot of data about the performance of the vaccine and its safety, and understanding which populations it works best in. So, it will be time well spent, those extra few weeks, in getting a really good understanding of which vaccine should be used in which people.
RICHARD GLOVER:
Okay. But I'll think about rolling up my sleeve in about March, something like that?
JOHN SKERRITT:
[Laughs] It depends where you come in the priority list, but I don't know where radio announcers come.
RICHARD GLOVER:
Yes, but elderly asthmatics, John, come on. Be a bit gentle with me. [Laughs] Thank you very much for your time this afternoon.
JOHN SKERRITT:
Okay, good talking with you, Richard.
RICHARD GLOVER:
That was John Skerritt, who is the Deputy Secretary of the Department of Health and the man responsible for the health products regulation group at the Therapeutic Goods Administration. Understandable decision, he says, by the UK to rush through an emergency approval for the Pfizer vaccine with all the paperwork and controls that he mentioned. But for us, because of our numbers, we are lucky enough to be able to wait and see some of that British data. This is a bit tongue in cheek, but I think it’s kind of right in a way.
Contact
