Deputy Chief Medical Officer Professor Michael Kidd and Therapeutic Goods Administration Adj, Professor John Skerritt’s press conference about COVID-19 – 4 September 2021

Read the transcript of Deputy Chief Medical Officer Professor Michael Kidd and Therapeutic Goods Administration Adj, Professor John Skerritt’s press conference on provisional approval of the Moderna COVID-19 vaccine and coronavirus on 4 September 2021.

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JOHN SKERRITT:

Well, good afternoon everyone. I'm pleased to announce today that the TGA has provided provisional approval to the Moderna COVID-19 vaccine, also known as Spikevax, for those in the 12-17-year-old age group. That follows on from the approval in the adult age group which we gave on 9 August 2021. The review was split, so we looked at the data for the adult group first, and its approval, as I indicated, was completed three weeks ago. And then we looked at the data on the adolescents, the teenage group more recently.

The recommended doses for the adolescent group is the same as the adult group, it's the same dose and it's given in the same way, and it's given four weeks apart, or 28 days apart. Now, regulatory approval for the Moderna vaccine has also been granted in the UK, Canada, the European Union and Switzerland. And our advice not only utilised the reflections of several of those countries, but also the external advice from the advisory committee on vaccines. And they are an independent committee of community and clinical medical experts.

Now, there's full data on the considerations available on our website, so there's further information on www.tga.gov.au. And the approval was based on evidence of strong ability for these vaccines to raise just as good, if not a little bit stronger, immunological response against COVID in this age group, as it does in young adults and older groups. The committee also looked at evidence on a very rare set of conditions called myocarditis and pericarditis. This seems to be associated with these messenger RNA vaccines. Now, the Moderna vaccine is a messenger RNA vaccine like the Pfizer one. And based on the experience of hundreds of thousands- hundreds of millions, I should say, of doses given overseas, it appears that while this condition is rare and tends to occur more often in younger men, it's generally transient, most condition- most of it resolves during rest. Some patients do require observation and treatment in hospital. But when you look at the overall benefits versus the risks, the benefits significantly exceed, so, it's yet another step in Australia's campaign to vaccinate the nation.

So, the other thing I'd like to talk briefly about is the work that follows on the announcements from the Prime Minister, of Australia obtaining doses from Singapore and more recently, just yesterday, the Prime Minister announced obtaining 4 million doses of vaccine from the United Kingdom. And these are dose swaps because at present, those countries have more vaccine than they need right now, and then later, when Australia has an abundance supplies of vaccine, we will be able to return vaccines because, as people know, we have purchased many more vaccines than we need for basic coverage of the population. And for that reason we're able to help countries in the region, who are poorer than us but also we're able to engage in doses swaps later on.

I want to give a callout particularly to the staff in the TGA laboratories. Staff have worked almost every weekend over the last year, first of all testing facemasks, and now more recently a different group of staff in the labs are testing these vaccines. So as we are standing here on a rainy Saturday in Canberra, we have a team of staff, socially distanced in the white lab coats, testing the vaccine from Singapore. The vaccine from Singapore landed in Sydney late on Thursday night, a truck took it down on Friday morning, and ever since it arrived in the middle of the day yesterday, our staff have been testing those Singaporean doses. That's just an extra set of checks that nothing happened during transit, and that the vaccine is of high quality and safe for the Australian public. I'm hoping that all going well, those tests will be finished late tomorrow, and then the process of rolling out the Singapore vaccine to Australians who need it, to add to the existing vaccine purchases can commence.

Now, from the UK, the Prime Minister announced a purchase of 4 million vaccines, and the first lot of those vaccines will be arriving on two separate flights during the course of this weekend, they'll be arriving late tomorrow into Sydney. One is coming on special charter flight, and one is coming together with repatriated Australians coming via Perth.

And why is it 450,000 out 4 million? Well, it's a simple reason, because the vaccines are packaged in dry ice. And for safety reasons, no airplanes can carry more than a couple of hundred thousand doses worth at one time, because of the dry ice present. There are limits governed by international regulation on the amount of dry ice you can carry. So what it means is the vaccine from the UK will come to Australia in rolling waves. Our laboratories will also batch release it, and look at all the documentation. And we've already started to review the documentation. And I want to give a special call out to our corresponding partners in the US, the regulator, the MHRA, who have collaborated with us around the clock over the last few days on sharing us with that documentation. So we'll get that vaccine in waves over the next few weeks. And that also aligns with the ability of the system to roll out. But having 4 million extra vaccines from the UK and a half a million extra vaccines from Singapore is absolutely fantastic news.

I'll now turn to my colleague, Professor Michael Kidd.

MICHAEL KIDD:

Thank you, Professor Skerritt. So the approval of the Moderna vaccine for those aged 12 to 17 years by the TGA is great news. And the first doses, as Professor Skerritt has said of Moderna, will be arriving later this month. The government will now be waiting the advice of the independent Australian Technical Advisory Group on Immunisation, ATAGI, on how the approval of the Moderna vaccine for the 12 to 17-year-olds should be incorporated into our national COVID-19 vaccine rollout. And this advice is expected to be received this week. It follows the government accepting ATAGI's advice that the Pfizer vaccine be administered to adolescents aged 12 to 15 years, and bookings for that age group to receive the Pfizer vaccine will be opening on 13 September. There's very significant preparatory work, which has been undertaken by Operation COVID Shield on how the rollout will be expanded to include the Moderna vaccine. And the first doses of the Moderna vaccine will be made available through community pharmacies and also through workplace vaccination clinics. As Professor Skerritt has said, we have been advised that the first shipments of over 450,000 doses of the Pfizer vaccine from the UK have been loaded, and they'll be arriving in Australia over the weekend.

We've now had more than 20.6 million vaccine doses administered to people right across Australia. More than 62 per cent of the eligible population aged 16 and above is now protected with a first dose of a COVID-19 vaccine. And over 37 per cent of the eligible population have had a second dose. In the last seven days, we've had more than 1.9 million doses of COVID-19 vaccines administered to people right across Australia. And my thanks to everybody who has turned up to get vaccinated, but also to the people who are doing the vaccines across the country. Importantly, we now have more than 88.8 per cent of people aged 70 and above who are protected with a first dose of a COVID-19 vaccine, and 66.3 per cent of those age 70 and above are now fully vaccinated. We have 1.7 million more vaccines to go in the over-16s until we have 70 per cent of the eligible population having received a first dose of a COVID-19 vaccine, and 3.7 million until we have 80 per cent of people having received a first dose of a COVID-19 vaccine. So please keep getting vaccinated. The one thing we can all do right across the country to tackle COVID -9 is to go out and receive the vaccine. And if you've had your first dose, please make sure that you also get your second dose of the COVID-19 vaccine, so you have that sustained high level of protection against the virus.

If you have any questions about the vaccine, please talk to your trusted health care professionals. To your general practitioner, to your pharmacist, to the nurse in your local practise, to the people working in your state and territory hub, to the Aboriginal health workers if you attend an Aboriginal community controlled health organisation. These are the people who can tell you about the vaccines and about the vaccine rollout. As you know, this week, millions of Australians aged 16 to 39 have become eligible to start receiving the Pfizer vaccine. And I encourage everybody aged 16 to 39 to go on to the vaccine eligibility checker and make a booking for the first dose of your COVID-19 vaccine. While we have a number of vaccines now approved in Australia, do not wait for one or the other. The best vaccine is the one that is available to you right now. So please come forward and get vaccinated.

Professor Skerritt and I are very happy to take any questions. I think on the phone we have Tom?

QUESTION:

Just one for Professor Skerritt if possible. The UK's vaccine advisory body has declined to recommend vaccines to 12- to 15-year-olds, saying the benefits are only marginally greater than the risks. What do you make of that advice from that body, particularly given the Moderna approval for that?

JOHN SKERRITT:

Thank you, Tom. We're well aware of the advice from the UK. In fact, we work very closely with the advisory body. That's not the regulator. It's actually the body that advises on prioritisation, and their role, the JCVI as they're called, are focussing only on the health grounds. And so it's true, that as we know, while sadly there have been some younger people quite ill with COVID, by and large, the impacts of COVID infection on the younger people, especially teenagers, are much more mild than impacts on the middle aged and the elderly. And so at the moment the UK JCVI has said, let's just focus the 12- to 15-year-old vaccinations on those with other health things, such as heart problems, such as diabetes and so forth.

However, they also have said that they realise that there's broader issues like children missing school, like the social impact of families being unable to have their children go through all the normal things that children do as adolescents. And so the UK ministers and the Prime Minister are actually doing a review, together with the UK Chief Medical Officers, and there's four countries in the UK, so there's four Chief Medical Officers, on whether the broader educational and social issues should also be taken into account. So we may hear a different decision coming from the UK in the coming week.

MICHAEL KIDD:

Thank you, Tom. I think we also have to Fiona on the phone

JOHN SKERRITT: Ah yes, Fiona.

QUESTION:

Hi there. Thanks for this. I'm just wondering with Moderna- with the news on Moderna, what will- what [indistinct] will this [indistinct] from the timeline for the rollout amongst children?

JOHN SKERRITT:

Well, as I said, ATAGI is still to consider the rollout amongst adolescents. But Moderna vaccines are due to come into Australia in the latter part of September, so not only will we have 4 million additional Pfizer on top of the amounts of Pfizer we had originally planned to have, but Australia has an agreement with Moderna to provide 10 million doses between now and Christmas. So that's a million in the latter half of September, then 3 million in each of October, November and December. So Australia should have abundant supplies of Pfizer and Moderna vaccine, and also AstraZeneca vaccine in the months to come.

QUESTION:

Would that mean that all kids will be able to get a jab this year?

JOHN SKERRITT:

That will be dependent on the advice of ATAGI. ATAGI have already indicated that Pfizer is able to be applied- administered to two kids over 12. Their deliberations this week will be on Moderna. But there will be abundant supplies of those vaccines available in Australia. The prioritisation is also dependent on the individual state and territory approaches towards vaccinating different groups of people.

QUESTION:

A couple of follow ups. So Professor Robert Boyd has said to me this morning that Australia should actually be focussing on vaccinating countries in our region ahead of 12 to 15-year-olds, because of the extent risk posed by a new variant. You know, the so-called Omega variant or Lambda variant, if you like, of developing in a country such as Indonesia or Papua New Guinea. What's your response to that?

JOHN SKERRITT:

So we're doing a tremendous amount of work, both directly in collaboration with the Department of Foreign Affairs and Trade. And again, my team- I have a team of a couple of dozen people who support the regional vaccination efforts. And so we are supporting the safety systems and the regulatory approval system. So I'm delighted to announce that just this week, the Australian AstraZeneca vaccine was approved for use in Indonesia. We worked hand in hand with our Indonesian counterpart, sharing information on them, answering their questions. The first shipment of AstraZeneca is arrived in Indonesia. So up to 20 million doses of vaccine will be donated by Australia to Indonesia. We're also working very closely with the Asian Development Bank, who have more than AUD $10 billion, a tremendous amount of money, to provide in financing to countries in the region to purchase and rollout vaccines. So Australia is really occupying a leadership role in the region on making sure vaccines get out to those countries as soon as possible. So we need not be in an either or situation.

QUESTION:

Can I just clarify. You said 20 million just then, Professor. The announced figure thus far is 2.5 million. So is Australia actually looking to do more?

JOHN SKERRITT:

Over the coming period, there will be 20 million doses of AstraZeneca applied in the region. At the moment, the allocations obviously depend on need, depend on the state of the pandemic. And so Australia, for example, has been working very closely with Fiji. And most of the vaccine that has gone - and Fiji has some very impressive vaccination rates - almost all, in fact, of the vaccine that has gone to Fiji has come from Australian donations. So we're not saying this country gets so much now, this country gets so much now, because we've got to look at the course of a pandemic in those countries, and also their access to vaccine from other countries.

QUESTION:

To pick up on Fiona's question earlier about all kids possibly being able to get the - all kids over 12, I should say - get the jab by the end of the year. Can you just provide a little bit of extra clarity? And then further to that, what is the Federal Government doing? Is it working with the state on a ventilation plan in school? Daniel Andrews touched on this yesterday, but there clearly needs to be a national plan, not just a state by state piecemeal plan.

MICHAEL KIDD:

Thank you. So, as we said, the aim is to have everybody who is eligible to receive a vaccine against COVID-19 by the end of this year. And obviously, depending on the ATAGI advice, that also includes children age 12 and above. I will leave the question about ventilation plans for education to the National Cabinet.

QUESTION:

Federal Health Department's not discussed it, or?

MICHAEL KIDD:

Thank you. Well, the AHPPC, of course, has discussed infection control in schools and in many other areas, but we'll leave decisions about what happens in the Education Department to the Education Departments. Thank you. Thank you, everybody. Oh, sorry.

QUESTION:

Is there any more clarity- you talked about, I think it's 450,000 doses coming in on the flights. How long will it take, given the limitations of dry ice that Professor Skerritt referred to, for all 4 million to come in? Is it going to take 10 weeks? Is it going to take four weeks?

JOHN SKERRITT:

So this is happening during the course of the month of September. And given that we already have the additional vaccine from Singapore, and given that there is obviously, even though we've had a massive ramping up of vaccinations, and I think in these challenging times, it's something we can all be excited about, there is obviously limited capacity to administer vaccines. So it's quite prudent and sensible that these vaccines come in different waves during the month of September. Now we're working with the British. In fact, we're- essentially, one of the planes is a charter flight. It's almost offering for what you could call a shuttle service. It's going to go back and forwards to London, to Sydney, and London and Sydney, and London and Sydney. So we're expecting during the course of September that almost all, if not all - but that will depend on flight schedules and it will depend on the British - of that vaccine will arrive in Australia.

QUESTION:

One more question, Professor, on the efficacy of the Pfizer vaccine. There are pre-print studies, at the very least that shows it starts to decline after about six months. Now, people in Phase 1A, the first people in Australia get their jobs, Pfizer, that was February and March. When you get to the six-month-old point, we're talking about late September, early October. What is the roadmap for boosters, particularly amongst people who are immunocompromised, who've had organ transplants, those sorts of things?

JOHN SKERRITT:

So it starts to decline at six months. There is still quite high levels of protection at six months. And the role of boosters is being discussed by regulators and groups internationally. So, for example, on 17 September, the USFDA and the Centre for Disease Control have a major meeting to determine the role of boosters within the US. And of course, they started their vaccination program a bit earlier. So I expect that boosters will come in at some stage.

But we - and also the vaccine implementation groups such as ATAGI - are very closely looking to see what the Americans are doing, given they have so many more patient individuals who have been vaccinated. And we will look closely at their guidance. It may well be for immunocompromised and other individuals are boosted first, but they're the sorts of discussions that are going to happen in a very large meeting on the 17th, which many of us will listen into.

QUETSION:

Professor Robert Boyd and Professor Jamie Triccas have both said to me that the people who are immune compromised, even more so than people who are in aged care, who are also in that 1A cohort, they really need to - we as a country need to be starting revaccinate or given them a third dose by the end of this year. Is there a roadmap perhaps for that?

JOHN SKERRITT:

This is something that ATAGI is, and I do attend many of the ATAGI meetings. This is something that ATAGI is closely engaged in. It's something that the Europeans are closely looking at. And it's a key part of the US consideration. So during the course of the next few weeks, the role of booster's firstly and secondly, whether they should start with people who are immunocompromised will be looked at, and then there'll be announcements following that time. But people can be assured that even though the vaccine efficacy drops off a bit after six months or so, it is still providing good protection even after six months.

MICHAEL KIDD: 

Thank you, everyone.

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