The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer vaccine as safe and effective for use among Australian children aged five to 11-years-old.
Subject to final approvals, the Australian Government expects to start rolling out the vaccine to children from January 10 next year.
The vaccine dose approved by the TGA for children aged 5 to 11 is the same safe and effective vaccine used for other age cohorts, however is one-third the dose approved for those aged 12 and over.
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Health Minister Greg Hunt said a batch testing team and a TGA team "will be working right through Christmas, right through the New Year" ahead of the provisional rollout date.
"The message for Australians is very clear… Australian children will have access to Pfizer vaccines and it is recommended for children right across Australia," Mr Hunt said.
"It is about keeping our kids safe, keeping our families safe, keeping all Australians safe."
Prime Minister Scott Morrison said there was plenty of supply and that distribution plans had already been arranged with the states and territories.
"There's plenty of vaccines, there's plenty of opportunities to go and have them," he said.
Mr Morrison said state-run vaccination clinics would continue to operate and that "lots of engagement" with state and territory agencies had occurred to get the roll out "ready to go".
He said parents would have the choice to get their children vaccinated before they returned to school in 2022.
The government expects to receive ATAGI's recommendations on how to incorporate this safe and effective vaccine into the nation's COVID-19 vaccination program over the coming weeks.
Subject to advice from ATAGI, vaccinating the approximately 2.3 million children aged five to 11 in Australia will build on the rapid uptake of vaccination among children aged 12 to 15.
In just 11 weeks, more than 76.6 per cent of this group have had at least one dose of vaccine, with 67.5 per cent having completed their two-dose course of vaccination.
Across the country, 87.9 per cent of Australians aged 16 or over are fully vaccinated. More than 92.8 per cent have had at least one dose of COVID-19 vaccine.
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The TGA's provisional approval of the Pfizer vaccine for five to 11-year-olds was based on a careful evaluation of available data to support its safety and efficacy among this age group.
The vaccine dose approved by the TGA for children aged 5 to 11 is the same safe and effective vaccine used for other age cohorts, however is one-third the dose approved for those aged 12 and over.
The Pfizer vaccine for 5 to 11-year-olds will be distributed to vaccine providers in different packaging to the vaccine approved for people 12 and over, and will be clearly differentiated by being dispensed from orange-capped vials instead of grey or purple capped vials.
As with other age groups, the use of this vaccine in children aged 5-11 years should be given in two doses at least three weeks apart.
TGA Deputy Secretary Professor John Skerritt said the vaccine has been extensively 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," he said.
"The response of the body, the immune response, was identical to that in young adults."
Professor Skerritt said health authorities are confident in the safety of the vaccine.
"More recently, there's actually been results published in one of the world's top three medical journals, the top American medical journal, the New England Journal of Medicine.
"In that journal, the result showed that 91 per cent vaccine efficacy.
"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."
Planning underway
The government said significant planning work has already been undertaken involving the COVID-19 Vaccines Taskforce, the states and territories primary health professionals in relation to how the vaccination rollout will be extended to children in this age group.
It is expected the vaccines would initially be made available through general practices Aboriginal Health Services, community pharmacies and state and territory clinics.
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"The Commonwealth government will continue to work closely with vaccine providers and states and territories as a priority to provide the opportunity for children aged five to 11 to receive a first dose of this COVID-19 vaccine in the lead up to and in parallel with school returning in 2022," a government spokesperson said.
"The government has an agreement in place with Pfizer to receive sufficient supply of the paediatric vaccine for the entire population of children aged five to 11 in Australia.
"The first shipment of children's doses are due to arrive in Australia by early January and will undergo the same rigorous batch testing processes in the TGA laboratories as other batches of COVID-19 vaccines."
The TGA is also currently evaluating an application from Moderna for its COVID-19 vaccine to be used in Australia for children aged six to 11 and the government already has supply deals in place to make it available should it be approved by the TGA and recommended by ATAGI.
This two-step TGA and ATAGI assessment and approval process is the same rigorous process followed for all COVID-19 vaccine approvals in Australia.
