I’m delighted to be able to announce today, that the Therapeutic Goods Administration, Australia's medical regulator, has approved access for five to 11-year-olds to the Pfizer vaccine.
They have made a careful, thorough assessment, determined that it is safe and effective and that it is in the interests of children and Australians for children five to 11 to be vaccinated.
This is the first of four critical steps that focused on the safety and effectiveness of vaccinating children, the first is the TGA approval.
The second is the recommendation of ATAGI. We are expecting that in the coming weeks. ATAGI is the Australian technical advisory group on immunisation
The third, then, is training in relation to the use of the Pfizer vaccine in paediatric cases or for children five to 11, and then finally it’s the batch testing, which is done by the TGA.
Our batch testing team, our TGA team, will be working right through Christmas, right through the new year and a provisional expectation at this stage is that we have been able to bring forward the commencement of the paediatric doses or the children's doses to 10 January.
That’s our provisional date, but the message for Australians is very clear. From 10 January, Australian children will have access to Pfizer vaccines, and it is recommended for children right across Australia. It is about keeping our kids safe, keeping our families safe, keeping all Australians safe.
In terms of the vaccination program, that continues to go from strength to strength. At the moment we are at over 39.6 million doses in Australia. We are now 92.8 per cent first doses and 88 per cent second doses.
Just to look at what has happened with our 12 to 15 year olds, if I could focus for a moment, we are at 76.7 per cent more than three quarters of 12 to 15 year olds who really, over a matter of just beyond 11 weeks, have already had a first dose. And more than two-thirds of 12 to 15 year olds, 67.8 per cent, of 12 to 15 year olds, are already double dosed.
So Australian teenagers have stepped forward to be vaccinated. I know my own son is in that category, and he went down to the pharmacy. He had his vaccinations there at Mount Martha, had the Moderna, in his case.
This is the children's dose of Pfizer, the children's Moderna is also being considered by the TGA and they’ll form a view that based on the data in the coming weeks. There are plenty of vaccines, plenty of options for every Australian child between five to 11 to be vaccinated.
And we want to thank all of those people, who have stepped forward, been vaccinated so far, and to continue to urge Australians to join that 92.8 per cent of 16 plus to join the over 76.7 per cent of 12 to 15 year olds. And this is your chance to protect your children, protect your family, and help protect Australians.
With that, I’ll invite Professor Skerritt.
Thank you, Minister, and good morning everyone. As the Minister said, TGA has provisionally approved the Pfizer COVID-19 vaccine for five to eleven-year olds.
And I just want to talk a little bit about the vaccine itself. It’s the same actual vaccine molecule, although it’s formulated differently for children. It’ll be in a different colour cap, it’ll be in a vial that will have an orange cap to distinguish it from the adult ones, which are grey or purple.
It’s one-third the dose, because like medicines, often with vaccines you get off with the smaller dose for younger children. So, it’s one-third the dose.
It has extensively been clinically tested. It was tested in a trial of almost 2500 children aged five to 11. And in that trial, over 1500 received a vaccine. And the response of the body, the immune response was identical to that in the young adults.
So, more recently, there’s actually been results published in the world- one of the world’s top three medical journal, the top American medical journal, the New England Journal of Medicine. And in that journal, the results show that 91 per cent efficacy. So, the efficacy is essentially the same in adults, as it is in this group. So, we’re confident in the performance.
There were no safety signals, as we call them, no safety problems identified in those trials. The children had some of the same things that adults get, tiredness, sore arms, headache, and so forth. But these tended to be brief and fairly short lived. So, we’re confident in the safety of this.
We join a number of other countries, although we are one of the first. So, the United States has now been rolling out this vaccine for about three weeks. Canada is starting its rollout the Europeans have given a recommendation, and the Israelis have also approved it.
I just want to talk a little bit, because we’re often asked, well, why vaccinate kids? Because kids do not get, generally, as sick as adults. But, I emphasise the word generally.
Now, there’s 2.3 million kids in this age group, and some rather sobering statistics. A bit over a fifth of all cases of COVID are actually in the under 12’s. And, indeed, some of the earlier data with Omicron suggests that that may actually be higher for Omicron variant.
So, our under 12’s who are currently unvaccinated, do catch COVID. Now, while most kids to get a fairly mild infection, and only a limited number end up in ICU, which is great, there are bigger impacts. Unfortunately, about one in 3000 of the kids who get COVID, actually end up with this funny immunological condition called Multi-System Inflammatory Condition.
And those kids can end up being very sick for months. It’s not the same as long COVID, but it has some things in common. And it has a whole range of symptoms, where the kid is just not well, and that’s one of the things we’re protecting against by vaccinating children.
One of the other things, of course, is the ability for kids to live a normal life. I couldn’t imagine, if I was a young kid, who, of having had two years of interrupted school, not being able to play sport, and all the normal social things, catching up with friends.
And so, the effects on social and educational and sporting and physical development of these kids, has been affected by COVID. And the ability to vaccinate those kids so that they can return to those activities, their parents can be confident they can return to those activities is a real step ahead.
We do know that kids often transmit the virus back to their families. About two-thirds do. And at a lower rate, they also transmit the virus within the broader school context.
So, just to finish, the TGA approval is for vaccination at least three weeks apart. We await the ATAGI advice. One of the key things that ATAGI will look at is the gap between the two doses, because there’s been some emerging decisions in places like Canada that are suggesting that children should be done two months apart or eight weeks apart to get a stronger immune response.
And so, that is why both the TGA decision and the ATAGI advice are very important for Government. Thanks very much.
Thanks very much to John, and I’ll start, if I may, with those on the telephone and then come to the room.
Thanks, Minister. I’m just wondering how confident are you that ATAGI will recommend that all five to 11 year olds get the jab from 10 January?
Or could say it be limited to kids that are immunocompromised first?
So, obviously ATAGI is independent and they’ve operated in a genuinely independent way, with our full and total support.
But the early advice is they’ve been working in parallel with the TGA throughout and there are no red flags, and so our expectation is that they are set to approve following the TGA.
But again, they will operate independently and we are expecting that advice in the coming weeks. But we have set a provisional 10 January date based on the preliminary advice so far.
Good morning, Minister. Just two questions. Firstly, given that we saw a push particular from Queensland to have all children to be able to have access to the jab initially, now that it has been announced, do you believe they may hold off opening state borders until our first kids hit 80 per cent as well?
There is no reason for that. The Doherty modelling was set out very clearly on the 80 per cent rates for double dosed across the country for 16 plus.
And what we have seen now is that in terms of the 12 to 15 year olds, we’ve now had an extra 1.8 million vaccinations over and above the Doherty modelling.
The Doherty modelling was based on an 80 per cent national rate for double dosed and didn't include 12 to 15 year olds.
So, in addition to the Doherty modelling as I say, approximately 1.8 million extra doses, and the Doherty modelling was based on the 80 per cent.
We’re now at 88 per cent double dosed for 16 plus. So, Australia is well ahead of the Doherty benchmarks and the Doherty expectations.
So, there should be no reason for this to be anything other than providing additional impetus to reuniting Australians.
Just my second question, sorry Minister. Sorry.
Senator Sam McMahon has been accused of throwing punches at a party function at the party’s general director. When will Government MP’s and Senator’s stop behaving badly?
I apologise, I’m not aware of this incident, and so it’s not appropriate to comment on that.
I do know, of course, there was a very egregious incident in the Senate, this week. Senator Lydia Thorpe from the Victorian Greens made comments which were deeply offensive and vile in relation to Senator Holly Hughes, so I think it’s incumbent on all of us, everywhere, to ensure the best behaviours and be role models.
I hadn’t heard, until your question, of the claims so it wouldn’t be appropriate of me to comment on those.
Clare, from the Daily Telegraph.
Thanks, Minister. The World Health Organisation has warned that it will still be many weeks before we have an understanding of the infectiousness and rate of severe disease that Omicron might cause.
Is that going to cause problems for the government’s temporary pause on reopening international borders for some visa holders from December 15, if we’re not going to have the answers to some of the questions that were the reason for that pause?
And also, just with the 5 to 11 year olds being vaccinated, does that factor into how Australia will manage Omicron? Is it more likely to pursue reopening if we know that that protection for younger children is coming?
So, two things there. Firstly, in relation to Omicron, I was briefed this morning by both the Chief Medical Officer Professor Paul Kelly and the Deputy Chief Medical Officer Michael Kidd.
At this point there are 15 cases that have been identified in Australia. Others are under investigation. I believe there are 41 countries, on our latest advice, that have identified the variant.
So we continue to focus on that information. We’re reviewing, daily and weekly, the travel restrictions. There are no plans to change the current proposals, but our message is very clear: safety and medical advice first. That’s been our approach throughout the pandemic, and that will continue to be the approach.
So if the medical advice changes, then we change the rules in accordance with that. But as of this morning there was no change in that advice and no change in that timeframe, from my discussions with the Chief Medical Officer and the Deputy Chief Medical Officer.
In terms of vaccinations, I think what the 5 to 11 year olds does is it increases our confidence, it increases protection in the nation, and I think they’re very important.
I will ask Professor Skerritt, who’s been involved with the South African briefings, I think he’s had extensive engagement with the international bodies and South Africa, for his preliminary advice in relation to what we know and what we don’t know.
I think it’s very important to be upfront about that with regards to the three variables that flow from the Omicron.
Thank you, Minister. So, with Omicron, clearly the greatest experience is in South Africa, although as the Minister said now over 40 countries worldwide have reported it.
Early indications are that it provides a milder course of disease, although usually there’s about a two week lag to work out whether there are going to be cases of hospitalisation and severe disease. So that’s why the lead-up period to Christmas and exercising caution is so important.
The other thing that obviously we’re looking at is, firstly, how well vaccines work against Omicron. There are certain tests you can do with cells and antibodies isolated from vaccinated individuals.
So, already in Australia we’re growing that vaccine, as it is grown up in laboratories in a number of other countries, and those laboratory grown versions of Omicron can be used to test how well the vaccines are and give us an indication of the level of protection.
Now, companies have said that they are ready to develop and are starting to design new vaccines for Omicron. But I remind people that if we go back six months ago with Delta, or even seven or eight when it first appeared in India, we thought we might need a new vaccine for Delta, and the good news was that the current vaccines, notwithstanding how widespread and how severe the outbreak was, the current vaccines held us in good stead. So it’s really a safety measure that these companies are developing vaccines.
The other things are obviously checking for treatments, and there’s a range of treatments that are approved or currently being evaluated. And also the tests, such as the rapid antigen test.
So the work never stops, and when a new variant comes we have to check everything. But we’re quietly optimistic, but I think it is important to be cautious, and emphasise we’ll know a lot more in the next seven to 14 to 21 days.
Thank you. I might come to those in the room now.
Professor, can I ask, with this provisional approval, is Omicron a consideration?
We looked at the data, which was against people with Delta, and some Alpha and other variants. So clearly when the clinical trials were done of this vaccine, a few months ago, Omicron hadn’t been anticipated.
I mean viruses, and this is nothing special with COVID, in fact, the flu virus actually mutates faster than COVID and we have a new flu vaccine composition each year. So this is how viruses act in the real world.
So, Omicron is a consideration as far as the importance of vaccinating a broader population. But, as I indicated earlier, issues such as getting kids back to sport, getting kids to be confident for their parents to send them back to school every day, getting kids to be in a position where they don’t accidentally infect their families, they were the important considerations.
And of course this symptom of multi-system inflammatory disease that unfortunately some young kids have for months after, even if they recover from the initial infection. So, they were the main considerations, I guess Omicron is an additional one.
What makes you think this is the best option for this cohort?
Well, this particular vaccine for the 5 to 11 year olds.
Well, the Pfizer vaccine and the messenger RNA vaccines in general have proven to really be a miracle of science. And it sounded blasé, but I actually put it up there with the lunar landing in 1969 as one of the most dramatic scientific advances that we have done in the last half a century.
The fact that we were able to take this technology, no one 18 months ago knew whether or not these messenger RNA vaccines would work, and they’ve been outstandingly successful.
And so we’re confident, from the data we have, that they’ll be just as effective in this young age group as they are in teenagers and adults.
Professor, you’ve spoken a little bit about the extensive research that’s gone into this. But there is a lot of hesitancy still amongst parents not wanting to get their children vaccinated.
What would you say to parents who are hesitant?
Well, Australia has a tremendous track record, and the Minister’s spoken about it often, of vaccinating our children. We have one of the highest paediatric vaccination rates in the world, I think it’s correct to say, Minister.
And it’s something we’re proud of. Now, vaccination for these age groups is not mandatory. Parents will make their own decision on behalf of the children. But they can rest assured that this vaccine is not only being thoroughly used in the world, we also have the advantage of being a few weeks behind, not many weeks, the US.
Already in the US, it’s been rolled out in some millions of children, and I was talking to the number two at FDA just the other day, and they’re not seeing any red flags.
So we have that as confidence, but of course it’s an individual decision that parents will make on behalf of their family.
Professor, is there any consideration to the time frame for booster shots for this cohort?
For children? Well, early days yet. So, the first issue that will have to be considered, as I alluded to, is the gap between vaccinations for young children. And then, secondly, there’s no real data yet on how well, or how rapidly or slowly, the immune response decays, to use the word.
So, we know, for example, with Pfizer and that’s why- and Moderna and AstraZeneca, we know with all vaccines that in the over 60s and over 70s the immune response does drop off a bit faster than in middle aged or younger adults.
Obviously before a booster was looked at for kids, you’d want to see whether or not the immune response persists. It may well be that it’s more persistent in younger kids, we don’t know yet.
But generally the immune system does drop off the older you get. So, that’s the sort of work that will keep us very busy in 2022.
Just in regards to boosters, is there any sort of update or any additional information you can give us around looking at Moderna for a booster shot?
So, we’re actively looking at Moderna, we have essentially finished our evaluation of Moderna. We’ve gone back to the company and the usual process, of course is we look at it, we go to our committee, they always, as committees of experts have and we want them to, they’ll always have some questions and comments.
They’re now with Moderna. So we’re hopeful that Moderna will come back to us in the coming days and a decision will be able to be made about the Moderna booster. But as I say, the ball is in Moderna’s court.
So, the simple answer on boosters, and then I’ll just refer to vaccines over the course of the coming months to give you that sense of where we’re heading.
The decision on the Moderna boosters awaiting now only the final response from the company, is likely within the coming days. That could provide, if it’s approved, another additional option for Australians, and I think that’s very, very heartening.
The next thing is, in terms of our vaccines, for example if there were paediatric boosters required, because of the depth of contracts we have, we are in a position to meet all of the needs under all of the scenarios in Australia.
We have 51 million Novavax that are available, subject to approval, we have 60 million Pfizer that are available during the course of 2022 if, for example, there was a third dose for children, a fourth dose for everybody.
We’ve prepared for those scenarios. We have another 15 million Moderna that are coming, and paediatric Moderna are also being considered.
So as you think through the approvals to come, there’s firstly, the Moderna boosters, secondly the paediatric or 6 to 11-year-old in the case of Moderna, children’s vaccines, and then there’s Novavax, and they’re all just following the evidence as quickly as possible, but subject to safety being the number one priority.
So, I will say this: our TGA never stops, and I’m thankful, John, to you and your staff, and apologetic about the fact that so many people will have to work through Christmas on the batch testing.
But I will say to Australians that precisely because the TGA never stops working, we are in a position to bring forward and make children’s vaccines available, as we’ve done with all other vaccines, and achieve the extraordinary rate of 92.8 per cent vaccination in Australia.
We would urge all parents to give their children the opportunity to be vaccinated, and vaccinated as early as possible. This is an important step in protecting Australia’s children.
Thank you very much.
Excuse me, Minister, just one other question. There are exclusions being put in place at the moment for some children who aren’t vaccinated in the 12-year-old and above.
Would you expect that to be the case with 5 to 11s if they’re not vaccinated?
We’d hope that everybody has access to schools and to community events. So that’s a matter for states and territories. But above all else, our job is to make the vaccines available and to encourage parents to vaccinate.
As John said, we have one of the highest paediatric vaccination rates in the world. Our five-year-old rate at the moment is over 95 per cent for our National Immunisation Program vaccines.
I won’t make a prediction with regards to the COVID vaccines, but I will say they’re safe and they’re effective, and we’d encourage as many parents as possible to bring their children forward to be vaccinated. Thanks a lot.