Australian children aged five to 11 could receive the Pfizer vaccine against Covid as soon as 10 January, following provisional approval by the country's drugs regulator.
The Therapeutic Goods Administration (TGA) green light, announced by the federal health minister, Greg Hunt, on Sunday will likely be followed by an independent recommendation from the Australian Technical Advisory Group on Immunisation (Atagi) to use the vaccine in that age group.
Hunt told reporters the provisional approval was "about keeping our kids safe, keeping our families safe, keeping all Australians safe".
"From 10 January, Australian children will have access to Pfizer vaccines, and it is recommended for children right across Australia," he said in Melbourne.
Hunt said the TGA was also considering children's doses of Moderna, the other mRNA vaccine, and will form a view on that "in the coming weeks".
The head of the TGA, Prof John Skerritt, said the Pfizer vaccine had been "extensively clinically tested" including a trial of 2,500 children aged five to 11.
"The response of the body, the immune response, was identical to that in young adults," he said.
Skerritt said the children's Pfizer was the "same vaccine" but "formulated differently for children" - using one-third of an adult dose.
"It will be in a different colour, it will be in a vial that will have an orange cap to distinguish it from the adult ones, which are grey or purple."
Skerritt said there were 2.3m Australian children in the five to 11 age group and currently one-fifth of all Covid cases were in the under-12 group. That "may actually be higher for the Omicron variant", he said.
Skerritt said while "most kids" got a mild infection from Covid, about one in 3,000 developed a multi-system inflammatory condition and "can end up being very sick for months".
After a slow start due to inadequate supplies of Pfizer and the blood clot warning applied to AstraZeneca, Australia's vaccination program has recovered to world-leading rates.
Hunt said 92.8% of Australians aged 16 and over have now had a first dose of a Covid-19 vaccine and 88% were double-dosed.
Since vaccinations were opened to the 12 to 15 age group in September, more than three quarters (76.7%) in that cohort have received a first dose while two-thirds (67.8%) have had two doses.
Despite the improvement, Indigenous Australians still lag others in their rates of vaccination.
Hunt said on Sunday the addition of children aged five to 11 to the vaccine program should not change the national reopening plan which was based on vaccination targets in the adult population.
