RAFAEL EPSTEIN:
The AstraZeneca vaccine for coronavirus is the backbone of the Federal Government’s vaccine rollout. The issue is that in Europe they have pressed paused in any number of countries. So should we be worried here? John Skerritt is the head of the Therapeutic Goods Administration. The TGA sign off on every drug that comes into the country and especially something like a vaccine. John Skerritt, thanks for joining us.
JOHN SKERRITT:
Yes, good afternoon Raf. Good to speak with you again.
RAFAEL EPSTEIN:
Should people be worried about the AstraZeneca vaccine?
JOHN SKERRITT:
We don’t believe there’s any evidence for cause and effect. So one of the challenges with blood clots is sadly they’re much more common than people realise. So every day in Australia, 50 people – five zero – are diagnosed by their doctor as having various blood clotting diseases of the sort that you’ve talked about. And at any stage in people’s lifetime, 8 per cent of people, so again you know one in twelve, one in thirteen, will have a blood clotting episode. So this is a very common medical condition and just the same way that people who may have any medicine or any vaccine could coincidentally have blood clots, we haven’t seen any evidence that we believe suggests its cause and effect.
RAFAEL EPSTEIN:
So why are they pressing pause in Europe?
JOHN SKERRITT:
Well, the European- actually to correct you, the European Medicines Agency, which is the vaccines regulator, actually has not paused. Some individual countries have the legal powers to decide to pause within their own countries. And so some of those countries have taken what we believe is a very, maybe excessively, risk-averse approach. But the Europeans as a whole-
RAFAEL EPSTEIN:
[Interrupts] Can I interrupt, John Skerritt? And only because- I mean, I'm actually a big supporter of the idea that vaccines are a good idea. However, don’t you have a significant public relations problem? You've got a significant number of countries, Germany, France, Spain, Italy, Ireland, the Netherlands, Norway, Denmark, they have pressed pause on the vaccine for which you say there is no evidence of a problem. That's a problem in and of itself, isn't it?
JOHN SKERRITT:
It's a public relations issue. But we need to remember that the country that has used this vaccine most thoroughly, the UK in 11 million doses, has not detected any issues. And this is the same vaccine from the same company. And so the biggest experience globally of this vaccine is with the UK. And they have, as recently as 24 hours ago, have said it's not been confirmed that the reports are caused by the vaccine. People should still go - and I'm quoting from their website - should still go and get their COVID vaccine when asked to do so.
RAFAEL EPSTEIN:
Do you get a chance to ask those governments why they’ve pressed pause?
JOHN SKERRITT:
Yes. And so we work very closely with the European Medicines Agency and they in turn involve those partner governments. And those governments have taken the view, well, gee, we'll just pause. Many of them actually don't have much of this vaccine being rolled out, they’re using other vaccines. And so they've taken the view, well, let's pause and we'll do more investigation. There's a very big problem if you pause roll out of a vaccine programme, you actually can lose people forever. So, for example, in Samoa, two children died, two babies died after vaccination. It turned out that the vaccine had been mixed with a poison rather than with saline, salt water. What happened was that people stopped getting vaccinated against the measles in Samoa. And even though it’s a little country, 81 people died of measles, a totally vaccine preventable disease.
RAFAEL EPSTEIN:
Yes.
JOHN SKERRITT:
And so you pause a vaccine programme only when you've got extremely strong evidence that there's a problem going on. And we just don't have any cause and effect evidence that this vaccine- now, that's not to say we're not taking this extremely seriously. We are working literally day and night with the Europeans, their big committee that has all the top experts on vaccine safety in Europe is meeting Thursday Europe time. And we'll be tuned in to those discussions and so we will know if there's any new evidence. But we just don't have any evidence that there's a cause and effect here.
RAFAEL EPSTEIN:
Can I ask you to address one texter? Tracey sent this to us earlier. What does it mean for those of us who've had clots before? I'm all for the vaccination but this makes me worried. What would you say to her?
JOHN SKERRITT:
We don't believe that there's any evidence that this vaccine stimulates clots. And so the thing known as contraindications, which are the medical reasons why in medicine or vaccine shouldn't be given. And having had clots previously, especially if they've been medically treated with anticoagulants and so forth, is not a reason not to have the AstraZeneca or Pfizer vaccines.
RAFAEL EPSTEIN:
If we had other vaccine options, would we be pausing? Would that change your decision on this vaccine?
JOHN SKERRITT:
No. Australia does have other vaccine options. We have the Pfizer vaccine and we have the Novavax vaccine coming along. But to repeat myself, we just do not have plausible evidence that there is a cause and effect relationship. And the word plausibility is important here because it's hard to see from a biological or immunological mechanism how having a vaccine against COVID could actually cause- could directly cause a blood clot. With certain medicines you can say, well, yes, that affects the blood’s clotting mechanisms in the blood plasma. But there isn't a clear, plausible mechanism, some people have speculated, but there isn't a clear mechanism that would plausibly show why this particular vaccine would cause blood clots. And plausibility, as well as drilling down and looking at all the individual cases- so what we're doing together with the Europeans are looking at all these cases that have been reported in Europe. What we also don't know is whether these cases are more or less than what normally happens.
RAFAEL EPSTEIN:
In that normal background.
JOHN SKERRITT:
Yeah, well, as I said, in Australia, the background is 17,000 people a year, 50 people a day get diagnosed by their GP or in an emergency department in a hospital as having blood clots and sometimes they’re fatal blood clots. It's the first time anyone's ever had a clot, they die. They get in the emergency department, sadly. And so what we haven't got any evidence is that the background rate has increased. And in the UK- why we are really questioning this one is that in the UK, once you've now done 11 million people, that's an awful lot of people who have had this vaccine and we would have seen an increase in the background rate, and we just haven't.
RAFAEL EPSTEIN:
So you talk a lot about plausibility. Is it plausible, then, for two members of the Government, Craig Kelly and Matt Canavan, to question the rollout? Is that a plausible thing for them to do?
JOHN SKERRITT:
Look, individual government and opposition members will say what they want. It is concerning if this lowers public confidence in the vaccines. And I would encourage…
RAFAEL EPSTEIN:
[Interrupts] Do you think they are going to lower confidence?
JOHN SKERRITT:
It's hard to say. I'd encourage your listeners to listen to the medical experts, the infectious disease experts, the vaccinologists. And as recently as the last 48 to 72 hours on this issue of the European pauses and the blood clots, we've had numbers of Australia's top medical experts line up and essentially say, don't stop the roll out in Australia. It doesn't appear to be any cause and effect. Sadly, a lot of people [Indistinct].
RAFAEL EPSTEIN:
[Talks over] Well, those politicians make your job harder, don't they? There aren't significant experts saying this is a problem, but you have two members of Government. Clive Palmer's, I think, now letter dropping a similar sort of material. That makes your job very difficult, doesn't it?
JOHN SKERRITT:
There's a lot of factors that make the job of a regulator difficult, Raf. It's not a job for the faint hearted.
RAFAEL EPSTEIN:
Okay. Is there any significant data you're receiving yet on how the vaccines we will get affect transmission? There's a lot on it stopping serious disease and admitted to hospital. Are you getting any big data on transmission?
JOHN SKERRITT:
We’re starting to get good data. There's some studies, especially from Israel, on transmission, which- they’ve mainly use the Pfizer one, that's just the one that they contracted, and it's showing some positive results about transmission. I'd say we're still a month or two away from being able to make definitive statements, but we're really strongly encouraged by the Israeli data. There's also data from the UK and both England and Scotland where both vaccines have been used. And of course, they looked at transmission between health care workers. And again, there’s some really positive but preliminary signs there. So we're actually quite excited. We didn't want to overstate transmission. The first objective is to reduce serious disease and death, but it's starting to look encouraging about transmission. But it'll be a little while until we’ll be able to make black and white statements.
RAFAEL EPSTEIN:
There are tons of vaccines out there. Has there been any approach to you from either the Government or CSL for them to be making another vaccine once they've done- I think it's 50 million or 40 million doses they're going to produce of the AstraZeneca one. Has there been any moves for a different vaccine to be produced here?
JOHN SKERRITT:
Well, CSL are working very closely and very- they're working round the clock, too, very hard on 50 million doses. It's easy to say, but that's an awful lot of work to produce 50 million doses of a new product. And we're working literally with them on a daily basis on that. And so that's fully occupying their focus in the coming weeks and months. At a broader level, scientists and bureaucrats, and others, are looking at the possibility of whether Australia has a vaccine manufacturing capability for a wider range of vaccines. That's an open question. The world has been really impressed with these messenger RNA vaccines. That have never been successfully developed for any human disease. And for the fact that the first two to come to market have been so successful and so efficacious is really a plus. And so there could be a whole lot of diseases like AIDS and malaria, and tuberculosis, even though that's a bacterial disease. But other viral diseases and- for which it's been really hard to develop vaccines. And so we are excited about this. But it's a major investment.
RAFAEL EPSTEIN:
Has there been any approaches about- so the Johnson & Johnson one, like the AstraZeneca one? I think the MRNA one you mentioned, Pfizer, is that sort of technology- has anybody done any of those preliminary conversations with the TGA about developing- about producing more vaccines here?
JOHN SKERRITT:
We've had a number of conversations with companies, including about local manufacture of products. They’re commercial decisions. And in nature of that, I'm not able to disclose particular company names but there is potential interest in local manufacture of vaccines. We have the primary objective of getting vaccines out into Australians, and so the fact that CSL is manufacturing so many vaccines does give us a degree of security. But we also are securing the supply chains, not only for Australia, but we have a responsibility to the Pacific and South East Asia as well. And we're working very closely to make sure that they have access to enough vaccines during 2021.
RAFAEL EPSTEIN:
Do you think we should send something like 5000 doses to PNG?
JOHN SKERRITT:
Well, again, the PNG situation is quite serious. Some of the testing has indicated that a very significant proportion of those tests have come up positive. And so the Government will have more to say about this in the coming days, but it's been an active area of focus for both we within the Health Department, and I’m wearing my wider Health Department hat, as well as the Cabinet and the Health Minister in the last few days. [Indistinct].
RAFAEL EPSTEIN:
[Interrupts] Do they have to ask- forgive me. Do they have to ask you if they're going to send – 5000 is the number, because that's a number of health care people in PNG – would they need to ask your approval at the TGA for that?
JOHN SKERRITT:
No. What is required for vaccine to be used in Papua New Guinea is actually our equivalent in PNG to actually give its approval. Now, we've been part of a program that's run for the last three or four years in building their regulatory system. You can imagine, like a lot of poor countries, they don't have a very well developed or well-resourced regulatory system. And we've been working closely with them, cooperating, training, teaching, mentoring, and so forth. And we've talked to the Papua New Guineans three times in the last 24 hours about working with them on various vaccines to help speed up access in Papua New Guinea. And that's an important part of our regional responsibility. We're fortunate that we're not doing it from scratch. We have well-established first name relationships. We're able to pick up the mobile phone and talk to them. And so we will be working closely with Papua New Guinea in the weeks and months to come.
RAFAEL EPSTEIN:
Just a final clarification, there is some significant data, I think, to suggest that the AstraZeneca vaccine isn't as effective – still effective, but not as effective - with the variants first identified in Brazil and South Africa. Can a doctor talk about that with their patient?
JOHN SKERRITT:
In a doctor- well, first of all, the variant data is still an incomplete map. And so it's not as if we've got a complete picture of the efficacy against every variant for every vaccine. But you are right in that for example, in South Africa, for mild and moderately ill patients, the AstraZeneca vaccine wasn't as effective against the South African variant as it, say, was against the British variant. So what we're doing is essentially not stopping those conversations between doctors and their patients. Doctors and patients can talk to each other about different alternatives. The evidence, the data. What the controls are, because vaccines are prescription medicines, is your corner pharmacy can't put out an ad on the radio, commercial radio, of course, and say that: we have Pfizer. It's better, use Pfizer or whatever.
RAFAEL EPSTEIN:
[Interrupts] Sure. But can a doctor, say, do a newspaper interview or a radio interview about it?
JOHN SKERRITT:
If a doctor is doing a radio interview and talking about studies that say, have been published in top medical journals, they can. What the doctor cannot say is I am prescribing this because it's better and the other one has more side effects and so on. So it's a thin line, and we've worked together with the Melbourne-based Head of a College of General Practitioners and the Australian Medical Association to clarify what can and can't be said. Because in Australia, unlike the US, thank god, we don't permit public advertising of prescription medicines.
RAFAEL EPSTEIN:
It’s a good thing. Thank you for your time. Thanks for your work.
JOHN SKERRITT:
Thanks. Good talking with you, Raf.
RAFAEL EPSTEIN:
John Skerritt is the Head of the Therapeutic Goods Administration.
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