Federal Health Minister Greg Hunt announced on Sunday that the Therapeutic Goods Administration, Australia's medical regulator, had 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,” he said.
Mr Hunt said the approval was the first of four critical steps.
The next is a recommendation from the Australian Technical Advisory Group on Immunisation, which is expected within weeks.
“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,” Mr Hunt said.
“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.”
TGA head Professor John Skerritt said the provisional approval followed extensive testing.
“It has extensively been clinically tested. It was tested in a trial of almost 2500 children aged five to 11,” he said.
“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.”
Prof Skerritt said while young children predominantly got a milder disease and were less prone to hospitalisation, one in 3000 who got COVID-19 ended up with an 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,” he said.
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