LEON BYNER:
Well, you might have heard on 5AA news that Moderna's COVID-19 vaccine has been given provisional approval by the TGA and a million doses are set to arrive next month to be delivered through pharmacies, with a total of 10 million doses ordered by the beginning of next year.
Well, I caught up with the TGA's professor, and I think you'll be interested to know what he's had to say.
Professor Skerritt, good morning and thanks for coming on the programme today.
JOHN SKERRITT:
No problem, Leon.
LEON BYNER:
Now, how does Moderna differ from Pfizer and AstraZeneca?
JOHN SKERRITT:
Well, Moderna is more like Pfizer. Obviously, it's been independently developed by a separate company. It's a company, in this case, based just outside Boston in the US. But it's one of those messenger RNA vaccines. It doesn't alter your genes. But once vaccinated into the body, it produces the coronavirus proteins, and that means that it stimulates your immune system to protect you against viral infection. But it's very similar to the Pfizer vaccine, but obviously, developed in parallel, quite separately by a different company.
LEON BYNER:
It's new technology that's used to make drugs. Why has it been and become so successful to fight against COVID?
JOHN SKERRITT:
Well, the technology has been under development by a number of research institutes and by a number of companies for, the last couple of decades. But every year, we get better and better at it. No one knew that - if you'd asked me 12 or 18 months ago, no one knew that this technology was going to come up trumps.
And in fact, not only now does it seem to have potential for COVID, a whole lot of diseases, things like malaria, which it hasn't been possible - or HIV, that it hasn't been possible to develop vaccines against. And even treatments for cancer might be used for these messenger RNA type vaccines. So, it's really been one of the big success stories of medical research in the last few years.
LEON BYNER:
Yes, because we know that mRNA vaccines have never been used until the COVID crisis. And then many say, well, this is a leap of faith. What do you say to that?
JOHN SKERRITT:
Well, it's a leap - it's a leap of results. I think it would be rather cynical and ignoring the evidence, to call it faith. We have literally had hundreds of millions, in fact, I think it now might be getting towards billion or more, messenger RNA vaccines being used worldwide. It's at least hundreds of millions.
In fact, even Moderna has been used in over 100 million people in the US and the results are in. That real-world studies have shown that there are many fewer people getting sick with COVID once being vaccinated and even more importantly, many fewer people dying. And that's with both vaccines, AstraZeneca and the messenger RNA vaccine.
LEON BYNER:
Sure.
JOHN SKERRITT:
And so, it's not the leap of faith. This is real world evidence from hospitals.
LEON BYNER:
Can you take us through the checks and balances the TGA goes through before deciding if a drug is safe for human consumption? In this case, of course, jabs in arms.
JOHN SKERRITT:
Yeah. So, we do a lot of that and we have a large multidisciplinary team that works very, very hard on this. And we also work very closely with other countries. So, we look at all the data, of course, in rats and mice about - including pregnant rats and mice and other animals first of all, before we look at humans data, to make sure that there's no, for example, abortions or damage to foetuses and other, and other symptoms, because obviously, you can cut open a rat or a mouse and check that the liver and so forth hasn't been damaged.
So, we also then look at how well the vaccine's manufactured. And that's very important because it's important that the vaccine is made the same way every time.
LEON BYNER:
Why will pharmacists administer Moderna and not Pfizer at this point?
JOHN SKERRITT:
Well, one of the advantages of Moderna is that it actually can be stored at domestic refrigerator temperatures, or freezer temperatures, I should add, rather than the need to actually store it at ultra-cold temperatures while it's being shipped.
Now, we have found with Pfizer, it can be stored in freezer temperatures for up to a month, but Moderna seems to be able to be stored for very long periods. And so, for that reason, it made sense for pharmacists, for example, to have access to Moderna because of its more simple storage requirement.
LEON BYNER:
So, as a general rule here, because people ring us and say, oh, these vaccines are still in testing stage or they haven't really been properly checked and we've jumped a bit too early. What do you say to this?
JOHN SKERRITT:
Oh, look, anything but the truth. So, we're- look, we did the approval of Moderna, as I said, after a couple of hundred million doses have been administered in real- world human beings, not just in clinical trials. We also did the approval based on assessment of thousands of pages of evidence and also, with those individuals being followed for any adverse event.
So, this is not some experiment on a few dozen people. We have the data from hundreds of millions of real-world vaccinations that have been followed and looked at closely. So, I think that there is a very solid evidence base and a very solid safety base for what we've done with Moderna and indeed, with the other vaccines.
LEON BYNER:
Is it safe for pregnant women and especially young people too?
JOHN SKERRITT:
Well, there doesn't seem to be any concerns in pregnancy with these vaccines. And recently, the advice has changed. Clearly, it's always a discussion between the pregnant woman and her doctor on when and what to be vaccinated, and that applies for any medicine or vaccine when you're pregnant. But there don't seem to be any signals that are telling us that there's a problem with pregnancy.
LEON BYNER:
Alright.
JOHN SKERRITT:
As far as young people go, very recently the Moderna vaccine has been approved for people 12 to 17, as well as adults in the European Union and Switzerland. Just -and I say very recently, Switzerland was literally 12 hours ago, I think. We had that data and we're looking at the data for the 12- to 17-year-olds. And I'm expecting in the next three or four weeks, we'll reach a decision.
LEON BYNER:
Where's it manufactured?
JOHN SKERRITT:
It's manufactured in the US outside Boston, but Australia has secured security of supply for those doses you talked about earlier.
LEON BYNER:
And when is this going to be available?
JOHN SKERRITT:
Well, next month. Clearly the exact dates, discussions between government and the company, and I know the Minister was talking to the head of Moderna just on the weekend about that.
LEON BYNER:
Who gets the shot, the Moderna shot?
JOHN SKERRITT:
The prioritisation will be determined together with the states and territories and GPs and pharmacies. And as you know, we're in a pretty dynamic situation. Adelaide, fortunately, is looking good at the moment, but, of course, we've got a long road ahead of us in Sydney and also in Victoria and Queensland. And so, our department's working together with the state and territory governments, with the general practitioners, with the pharmacists in each of those states, and it'll be moved around according to the relative priority. As I said, the plan is for Moderna to go into a lot of pharmacies, but it may not be limited to pharmacies.
LEON BYNER:
Alright. So common side effects one might expect?
JOHN SKERRITT:
The common side effects are similar to those of Pfizer. You can feel nauseous after the shots. You can have a sore arm; you can feel tired. You can maybe feel a little bit shaky and fevery. But those side effects all seem to go away after 24 or 48 hours.
LEON BYNER:
So what do you say to those who are terribly trepidatious about having this shot?
JOHN SKERRITT:
Well, I would say think about what we've got to do, both as individuals, and as a society, to move on from COVID. This has probably been the biggest impact on any of our lives. You know, it's a bit like our parents or our grandparents' generation who remember World War 2.
LEON BYNER:
Yes.
JOHN SKERRITT:
This is probably our World War 2 so- or World War 3, except it's against the virus.
LEON BYNER:
Sure.
JOHN SKERRITT:
And so really, if we are to move on, vaccination is absolutely central globally and within Australia to getting out of a pandemic and returning to normal life. And we can show that vaccination has saved lives, many, many lives. If you look at Sydney at the moment, if you do a comparison with Melbourne, there were many people, sadly, dying in aged care in Melbourne at the peak of the Victorian pandemic. We haven't seen that in Sydney because of the power of vaccination. So vaccination is absolutely central.
LEON BYNER:
Now, does Moderna, the vaccine, require two doses?
JOHN SKERRITT:
Yes, it does. There is a bit of a difference with Pfizer in that the trials suggest that they work well four weeks apart. So a lot of people who get Pfizer, get it three weeks apart, although frankly, that's not in black and white. Pfizer works very well if it's given six weeks apart too. But Moderna is given as two shots, four weeks apart normally.
LEON BYNER:
Are we going to need booster shots for this?
JOHN SKERRITT:
Everyone would love to know the answer to that, including us. The good news with the Moderna is that it is still highly effective, 93 per cent, against catching the infection six months out. There's some very recent studies on that, and more importantly, almost fully effective against death or hospitalisation. But very few vaccines provide lifelong protection.
If you think of a flu vaccine, we all have to go and get booster shots each year because two reasons. Firstly, it wears off; and secondly, the flu strains change every year. We know there's changing strains with COVID and of course- but we don't know about the duration of protection. So I expect we'll need booster shots, but whether it's in 12 months or two years or 18 months after each vaccination, no one knows the answer to that yet.
LEON BYNER:
Just for the record, because people often ring up and say this is somewhat of an experiment. I think there's been a lot of work put into this, is there not?
JOHN SKERRITT:
Well there's been a tremendous amount of work on development of a vaccine, but also, regulators globally have looked at this vaccine very carefully. Now, we actually approved this vaccine 32 days after getting the full application. Now, I didn't say working days because sadly, my staff have been working seven days a week on this. But we're able to do so in 32 days because we had worked together with all the other big regulators globally. So it's not just Australian minds looking at the data; it's got Europeans, it's got Americans, Canadians and so forth, and we've been talking to them very regularly about what they've found. So I think we've had some of the best medical scientists and regulatory scientists look at this data and we're pretty confident this is a very good vaccine.
LEON BYNER:
So can most people have it? There'd be some of course who've got issues that maybe the doctor would say, no, best you don't.
JOHN SKERRITT:
Very rarely. So there is a rare issue with both the Pfizer and Moderna on a heart inflammation. A lin- [indistinct] of a lining of the heart called pericarditis or the muscle in the middle of the heart called myocarditis. And that's a rare side effect from which could actually affects some younger people, but as I say, it is rare. And if you suffer from that condition, a doctor may say: look, you're better off having AstraZeneca. But all that information is in the public leaflets that go to the people who do the vaccinations and also the background information going to the doctors, and we're being quite transparent that if you have this very rare heart inflammation, you might be recommended to have AstraZeneca. But this is rare.
LEON BYNER:
So there is a substantial difference between the vaccinations?
JOHN SKERRITT:
Well, the difference between, say, AstraZeneca and Pfizer in terms of some of the groups who may be more suited to one and the other. And as you know, AstraZeneca is- Pfizer, I should say, is preferred to those under 60. Although, in a pandemic outbreak situation like Sydney, where the importance is to get everyone vaccinated, being vaccinated is much more important than your choice of vaccines for most people. And not only in the Sydney situation, but Australia, the message is, if you can get the vaccine, go and get it, not only for you, but also for your family.
LEON BYNER:
Professor Skerritt, thank you for sharing the time to talk to South Australia today.
JOHN SKERRITT:
Good talking to you, Leon.
LEON BYNER:
That's Adjunct Professor Tom Skerritt [sic], giving you all the information.
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