LISA MILLAR:
Let's return to Australia's vaccine rollout now. And the Therapeutic Goods Administration is standing firm on its decision to give the AstraZeneca vaccine the full approval despite a list of European countries suspending their rollout over concerns of blood clotting. The head of the TGA, Dr John Skerritt joins us now from Canberra.
Good morning, Dr Skerritt, welcome to News Breakfast.
JOHN SKERRITT:
Good morning.
LISA MILLAR:
Anything that you have heard over the last 24 hours that has made you change your mind about Australia's approach to AstraZeneca at the moment?
JOHN SKERRITT:
No, it hasn't. In fact, we were on several- several of us were on video conferences until almost midnight last night with about 15 or 16 countries. And it's quite clear that the largest countries this have rolled out the vaccine - the UK with 11 million doses where they haven't seen any problems, and even some left-field countries such as Saudi Arabia who have rolled out a million doses and have quite a sophisticated monitoring system - have not seen any problems. The problems seem to have been limited to reports in Denmark, Germany and perhaps Norway, and it's important to emphasise that Europe as a whole, the European medicines regulator, is still strongly promoting that the rollout should continue.
LISA MILLAR:
But isn't the European Medicines Agency the one we're waiting for, for this emergency report? They actually haven't delivered that yet, have they?
JOHN SKERRITT:
So we talk with them last night and, yes, there is a committee meeting tomorrow night Australian time, tomorrow European time, which is looking at more of the evidence. We did a preliminary look at the evidence last night, and while we are working very closely on this, we don't have any signals that would tell us it's appropriate to stop vaccinating in Australia.
LISA MILLAR:
All right. And the- what do you think is behind them being so cautious? Because the different reports, I mean, I've just been reading just in the last couple of hours, we're getting reports from France that they're concerned now about another wave of coronavirus. So the pressure on them to be vaccinating people must be enormous. Therefore, you would read into that that the decision to pause the vaccinations is a big one for them to take.
JOHN SKERRITT:
It is a big one for them to take, and I guess the question is best posed to them. Individual countries in Europe can make their sovereign decisions to pause a vaccination program, notwithstanding there are large numbers of cases. But again it's important that countries that have the most experience with these vaccines - and of course the UK stands out here - have not seen these cases and have found this vaccine to be very safe and efficacious. And so the overwhelming majority of evidence, we're not talking about a vaccine that has only gone into a thousand or 10,000 people, it's gone into almost 20 million people by now, at least 17 million and perhaps up to 20. And so these are a few small users of the vaccine in the scheme of things.
LISA MILLAR:
Can I ask you about the Johnson & Johnson vaccine, which is just the one shot vaccine?
JOHN SKERRITT:
Sure.
LISA MILLAR:
We don't have a deal with Johnson & Johnson, but I know the TGA is looking into it because you're checking it out in case a deal might be done in the future. How is progress being made on that and what are your thoughts about that vaccine as a possible one for Australia?
JOHN SKERRITT:
Well, again as you mentioned, it will be up to commercial negotiations between J&J and the Government on whether or not the Government purchases it. Our role is to look at safety, efficacy and how well it's manufactured. We're working very closely on data we're getting from Johnson & Johnson. It's looking pretty good so far. We hope that before the end of April, we'd be able to make a decision. Why so long? Because we still don't have data from J&J. We may not get some of it until around about Easter, but we are quite confident that by the end of April we'll be able to make a regulatory decision on it. It's looking positive, but, of course, we got to wait until we have all the data and make a decision on all the data.
LISA MILLAR:
And the benefit of that one, of course, it is the single shot.
I just want to finish with a question on another issue, Dr Skerritt, which is the growing push to get psychedelic drugs cleared for mental health treatment. I know the TGA last month put out an interim decision on this, and the answer was no. What might change the TGA's mind about this? Are you considering it still?
JOHN SKERRITT:
We are still considering it because there's a second round of consultation. Now, I want to emphasise that in a number of states, such as Victoria, psychedelic drugs can be used under supervision in clinical trials and in experimental trials. So, it's not that there's a ban on their use in Australia. What we don't have in Australia yet, as for any other medicine, is the complete package of evidence that shows that they're safe and effective. There's some really promising early data, as there are for a lot of medicines, but in being a responsible regulator, we've got to wait until we got the overwhelming evidence that these products are safe and effective. And I'm really hopeful that in the coming months or perhaps the coming year or so, we will get that data and then as soon as we get that data, we'll be delighted to look at it and make a decision. So it's not a case that we believe that these things don't work, it's just that the trials are still underway.
LISA MILLAR:
All right. Dr John Skerritt, from the TGA, thank you for your time this morning.
JOHN SKERRITT:
Thanks very much.
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