JOE O’BRIEN:
And John Skerritt is the Deputy Secretary of the Health Products Regulation Group at the Therapeutic Goods Administration, and he joins us now from Canberra. John Skerritt, good morning. Before we get to the regulatory process here in Australia, just want to hear your reaction to this news that in the midst of this terrible pandemic, an apparently credible vaccine has been developed and approved by a reputable national regulator in this time frame.
JOHN SKERRITT:
Good morning, Joe. We actually met with the UK and the FDA and Europe and the other regulators last night to learn more in detail. We were aware that this was likely over the last couple of weeks. I do want to emphasise one thing, this is not an approval of a vaccine by the UK, it's an emergency use authorisation. Now, while that might sound like splitting hairs, the UK has gone to pains to emphasise that they’re still evaluating data in-depth and still do not have complete data on this vaccine. But because of a critical situation in the UK, they have authorised it for emergency use.
JOE O’BRIEN:
All right. And so just broadly then, your reaction to the fact that this has been developed in this time frame amidst this terrible pandemic.
JOHN SKERRITT:
Well, we’ve also been working closely with the other regulators and this particular company, Pfizer. There's been a number of vaccines, about four or five, that are quite advanced and have been developed in a very short period of time. The reason why they’ve been able to be developed in a short time is, and it's an overused word, the unprecedented amount of funding - billions of dollars have enabled steps to be done in parallel rather than in sequence.
JOE O’BRIEN:
So it's pretty extraordinary that we have got to this stage so soon?
JOHN SKERRITT:
It's remarkable, and also does reflect the technology. With these Messenger RNA vaccines, you don't have to wait to manufacturer large quantities of protein in fermenters - that can take months and months in itself. The manufacturer and scale-up is much quicker.
JOE O’BRIEN:
So what stage is the Pfizer vaccine at in the regulatory process here in Australia? And are there any implications for that process with the announcement from the UK overnight?
JOHN SKERRITT:
Well we’re sharing data, and they’re sharing data with us - the UK - and the Americans, depending on the quality of the data, are likely to, again, with their serious situation, make a similar emergency use decision just before Christmas, and they will all share that data with us.
It certainly helps us in our evaluation, but as a nation we’ve decided that these products should have a full regulatory approval. As it turns out, it will be a matter of maybe one to two months behind the UK and the US, but it will enable us to have looked at the data in more detail and to have more data in front of us.
JOE O’BRIEN:
And so if there is no difference in the information that the British authorities have and what you have about the Pfizer vaccine now, why will it the still take some time in Australia when it's already approved for use in the UK?
JOHN SKERRITT:
Well, I want to again correct you, it is not approved for use in the UK - it has what's known as an emergency authorisation. There's more than five pages that the British Cabinet is in the process of signing off of very specific conditions around who it can be used with, how it's going to be referred, how it's going to be extremely closely monitored. In Australia when we roll out the vaccine we want to it be rolled out broadly so that it's able to be used in the priority groups and then more widely in the community. That is also what the British have in mind early next year, but at the moment this is an interim step, it’s a authorisation, it’s not an approval.
JOE O’BRIEN:
Yeah, right. Okay. So what more information will Australia get by the likely time of approval here? For emergency use - approval that the British don't have now?
JOHN SKERRITT:
So what we will have, and it will depend when the company gives us the full information, but assuming we get the full information and then in the first couple of months of 2021 we’re able to do a full approval - we'll have data with more individuals than the British have, in fact, we'll also have the benefit of its experience over the next few weeks in elderly British patients and in front-line British health workers. We'll also have long-term safety data; we’ll have a couple more months of experience of whether there’s any serious reactions with this vaccine; and, we'll also know more about how it can be manufactured very consistently. At the moment, the British have only approved certain batches - they haven't given broad approval to the vaccine manufactured in an ongoing sense.
JOE O’BRIEN:
Yeah. And so what is the risk then now for the British giving approval for emergency use while they don't have that information from the remainder of the trials that Australia will have access to?
JOHN SKERRITT:
There are some risks. They know less about how effective it is. They certainly know less about how long the effects of the vaccine will last. And they will know less than Australia will know in a couple of months' time about whether there are potential adverse events. But we need to be mindful of the fact that in every two days in England - sorry, in the UK - in every two days they have as many COVID cases as we have had all year. And sadly, the UK has had almost 60,000 deaths - we’ve had, I think its 908, so they’ve had 65 times as many deaths as we have.
So the situation is very much an emergency in the UK and I can understand totally why they are moving earlier, even with the greater uncertainty.
JOE O’BRIEN:
What are the other vaccines at the same advanced stage in the regulatory process here in Australia? I think there are two of them?
JOHN SKERRITT:
Well, TGA’s- Yeah. TGA has actually given provisional designation, which means that we’ve seen promising early data to three vaccines. And the other two are the Oxford-AstraZeneca vaccine, and also one from Janssen, Johnson & Johnson. We also have been talking with more than a dozen other companies with vaccines in various stages of development.
JOE O’BRIEN:
And based on the UK decision overnight, do you think it's highly likely that the Pfizer vaccine would be the first available in Australia, if it passes the remaining trials?
JOHN SKERRITT:
There are three companies who have given us data and have made submissions. What they’re called are rolling submissions, because we don't have the complete final safety and efficacy and even some of the complete final stability data from any of the companies. So look, it's a three-horse race at the moment, and any one of those three companies could be the first one to get to the finishing line.
JOE O’BRIEN:
So how soon is it likely that any of those will be rolled out here if you are satisfied with the remainder of the results?
JOHN SKERRITT:
Well, we have to get the full data from the individual companies. And why they can't say you’ll get it on December 5 or whatever is because they’re still collating the data from the clinical trials which depend on infection rates. And as you know, the infection rates go up and down in different trials and in different countries day-to-day. But based on current projections, we'll receive final data for some of these products in December, and we'll be then hoping that late January into February we'll, if all goes well, have a regulatory approval. The government's committed, based on the vaccine's passing regulatory approval, for us to, as a nation, to be able to start rolling out vaccines by the end of the first quarter of 2021.
JOE O’BRIEN:
And so that’s around March. So what are the challenges distributing the Pfizer vaccine here in Australia, taking into account it has to be stored at such a low temperature?
JOHN SKERRITT:
There are challenges, and as I’ve said in other media, Pfizer have developed some very sophisticated eskies - most Australians will identify with what eskies are. These don't just keep your beer cold, they keep the vaccine down at dry ice temperature and they’re able to be refilled twice. Now we’ve got domestic borders opening up and more domestic air travel between the States and Territories, we believe that even the dry ice vaccine can be distributed. But certainly there are more challenges with distribution of any product that requires dry ice compared with something that's refrigerator temperature.
JOE O’BRIEN:
Yeah. And so is that feasible to be used in say, for example, in remote Aboriginal communities?
JOHN SKERRITT:
That waits to be seen. It will obviously depend how, how remote. If it was say a community in Katherine, which is only a couple of hundred kilometres from Darwin, it would be quite feasible. If it's a community that's only accessible from a multi-day road trip, it would be more challenging. But the dry ice is designed to last 10 and maybe even longer days – 10 to 14, and as I’ve indicated it can be refilled a couple of times. And I think we can get anywhere in Australia in under 10 days, and indeed under a couple of days. So there are certainly logistic challenges, but they’re not impossible challenges.
JOE O’BRIEN:
And what planning has already gone into logistics here in Australia surrounding the rollout?
JOHN SKERRITT:
Tremendous. There's a team of about 50 people who are stood up to work together with companies who are specialists in logistics. And the minister and the Prime Minister will be announcing more information on rollout in the coming days and weeks. But there's been a tremendous amount of planning within our Department of Health.
JOE O’BRIEN:
And have you already set out the order of who will be vaccinated first?
JOHN SKERRITT:
A committee which provides advice is still finalising that. But not surprisingly, the initial public statements from the Australian government indicate that the aged and frail, front-line health care workers, and also people who have what we call co-morbidities - other serious conditions like asthma, heart disease, and so forth. And then certain people in critical roles and occupations - just what the critical occupations are, the government has announced that more analysis and more work is being done. But the aim is that during the course of 2021, the vaccines will be available to all Australia. But clearly we need to get into the priority populations first.
JOE O’BRIEN:
Yes. And in the UK the military is involved he setting up a mass vaccination centre on a sports field in Bristol, I think it is. Will we see that kind of thing here in Australia?
JOHN SKERRITT:
We're fairly advanced in logistics, and certainly the military has had a role in things such as the bushfires and so forth. At this stage, the military isn't planned to play a major role in the rollout, but we are working together with well-established state and territory infrastructure. And my colleagues have been talking on a daily, probably an hourly basis, with the states and territory health departments about how these individual vaccines will be rolled out within the states and territories. Because, don't forget, in Australia the states and territories have the major responsibility for delivery of on-the-ground healthcare services.
JOE O’BRIEN:
So, would it more likely be confined to hospitals and GPs and teams going into aged care facilities and things like that?
JOHN SKERRITT:
Again, the Government will soon announce the who, and why and where withal, but certainly all the groups you mentioned will be involved. But there will be additional involvement and, again, it may well differ between states and territories because the nature of the health systems and their structure and the who, does what does differ between states and territories.
JOE O’BRIEN:
And what are the advantages of the other vaccines that you’ve mentioned being considered in Australia? And is it likely that there will eventually be a variety of vaccines distributed?
JOHN SKERRITT:
Well, the Government hedged their bets - and it wasn't just the Australian Government, every government- every major government globally has purchased a range of vaccines - and that was really because three, four, five, six months ago, no one knew which of those particular vaccines may be effective. Now, we’ve had an incredible stroke of good fortune and good science, in that several vaccines have come up with fairly impressive results.
But we don't know, for example, whether certain vaccines may be associated with more things like headaches and fainting and fatigue, and other adverse events - what we call reactogenicity, we also don’t know which vaccines will have a longer lasting effect at this stage. And so, it may be that one or two of the types of vaccines last for many years and others may last for a shorter period of protection. And that's why I think it was quite clever that most governments, including our own, invested in a range of vaccines rather than putting all their eggs in one basket.
JOE O’BRIEN:
And so, you're pretty confident all of Australia will be vaccinated by the end of next year?
JOHN SKERRITT:
That has- that’s been the public statement of government. Now, clearly there's a few things that have to happen before that, and the very first one is that companies have to come with data, and the data on safety efficacy, how well they work, and the quality, has to meet our very strict standards. But assuming they do meet our strict standards early in the year, the aim is that there should be vaccines rolled out throughout 2021.
There will still be people needing to be vaccinated after that, that's certain, but the Government is committed to try to have vaccines rolled out across the country by the end of next year for all people. But clearly with priority groups having access from March onwards.
JOE O’BRIEN:
And this is, as you mentioned before, this is all happening at an extraordinary pace when you consider what's happened over history with- when you consider how health organisations around the world have approached pandemics. Do you have any reservations about how fast this is all happening?
JOHN SKERRITT:
It's important to communicate why it's been able to be done so quickly. And as I said, the biggest reason is just the sheer amount of money that's been thrown at this - this has been the biggest investment in medical product development in the world's history; billions and billions of dollars. And what it's meant is that companies and researchers have been able to do things at the same time, rather than in a sequence.
Because generally so many vaccines and medicines don't reach for market, they fail halfway through the process. People do one step at a time one after the other, because that's best for commercial financial risk. But here, governments have said, we will pay X hundred [audio skip] dollars, even if- to manufacture vaccines, even if a vaccine doesn't work. They're taking the risk here, and that's been a phenomenon globally.
The second thing is, is that we’ve- this is not our first coronavirus-type infection, and so we have been able to leap-frog based on some expertise that globally was obtained with things like SARS, MERS in the Middle East, and even some learnings from the influenza pandemic of 2009. And so, that has been a major thing.
And finally, development of vaccines has been the number one research priority of very many top-line global research facilities - it's been the big thing in medical research this year. So, when you put hundreds of thousands of the world's best experts, billions of dollars, and take the risk to be able to- commercial risk, to be able to do things at the same time rather than do something, wait and see how it goes commercially before you spend another $100 million, they're the reasons why these vaccines have been able to be developed in a period of under a year rather than five or 10 years.
JOE O’BRIEN:
And taking that all into account, will you be able to give any guarantees with vaccines in Australia that there won't be any long-term side effects that we just don't know about yet, considering how fast this has all happened?
JOHN SKERRITT:
No regulator or public health physician would guarantee that any medicine or vaccine will be free of side effects. What's really important for us to do with long-term and serious side effects is actually - and we have a team of over a dozen doctors and pharm- and supplemented by scientists and pharmacists, disease detectives – but actually their role is to look to see whether there's cause and effect.
Because, sadly, once you vaccinate a million people or 10 million people or 25 million people, just by coincidence you're going to have a number of those people have strokes, a number of those people have heart attacks. Because you take any room full - a very big room - full of a million people, statistically a certain number of people will have serious health themes.
What our role is to do, is to actually determine cause and effect, and whether there's what we call a signal coming from that vaccine, or whether it was, sadly, other reasons why that person had a stroke or developed multiple sclerosis. And that's the role of regulators.
The other thing is that we're only a population of 25 million, and we're working as a global network of regulators across the billions of people who will be vaccinated to get better understanding as soon as possible of potential rare or very rare adverse events.
JOE O’BRIEN:
And just before I let you go, John Skerritt, because I know you're a busy man. What- just give us an insight of what is was like to be in that meeting last night with the key global players on this front, at this critical moment in the pandemic?
JOHN SKERRITT:
Well, Australia is actually- it just so happened we're actually the Vice Chair of this group of regulators, even though Australia on the global stage is number 12, number 13 economy, we're actually Vice Chair. So, we have direct access to the heads of the British regulator, the heads of Europe, the heads of the American regulator, the heads of the Canadian regulator. We talk daily by email and over the phone and by endless Skype meetings almost every second or third day; so it's an extremely close working relationship. And that gives us confidence, that even if something rare happens in a country of 250 million or 300 million like the US, we'll get that information within hours. And so, this has really also been an unprecedented - to use that cliche - example of global cooperation.
JOE O’BRIEN:
And what was the optimism like in that meeting last night?
JOHN SKERRITT:
We're optimistic but cautious. Regulators by their nature are cautious, and this is why the British were at pains to emphasise that this is not a full approval of that product, and they're still looking at data and they’ll still look at more data as it comes. It may well be the British are in a position to do a full approval of the Pfizer vaccine in February or March, but they were at pains to emphasise that because of the very, very serious and extremely sad situation - many of us here in Australia have friends and relatives in the UK, almost every second person does.
It's a very critical and serious situation, they're at pains to say that's why they're doing the emergency authorisation, but they're still continuing the review of the data. But there is a sense of optimism.
Clearly, you’ve got to go further than company press releases. We do have much more data, and the data does seem to back up the optimism in those press releases. But we still don't know a lot about these vaccines, such as whether people will have to be given booster shots every year, or whether, for example, like mumps vaccines and so forth they last longer.
JOE O’BRIEN:
And it’s still some way to go, but so much optimism out there. John Skerritt, thanks so much for making time to talk to us this morning.
JOHN SKERRITT:
Thanks very much.
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