Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), has approved a key step towards the Pfizer COVID-19 vaccine being made available for use in children aged five to 11.
The TGA said on Wednesday it had granted a provisional determination to Pfizer Australia in relation to the vaccine.
It is currently provisionally approved only for use in people 12 years or older.
“The granting of this determination means that Pfizer is now eligible to apply to vary the provisional approval for the vaccine to include children aged five to 11 years,” the TGA said in a statement.
“This provisional determination is the first step in the process and does not mean that an application for variation has been made by the sponsor or that any such variation will be provisionally approved by the TGA.”
However, Pfizer will now need to submit comprehensive clinical data on trials done on the age group to gain approval.
Federal Health Minister Greg Hunt said the assessment would be done “very quickly” and had the potential to be completed in a matter of weeks.
However, he said the vaccine would also need to receive the green light from the technical advisory group ATAGI.
“It will be assessed very quickly,” he told 4BC radio.
“We are hoping they (Pfizer) bring it forward in the coming weeks.
“We’ve got the supply, and we’ve got the distribution mechanisms.”
Pfizer told AAP this week that the company had provided trial data to the U.S. regulator for initial review.
A trial of the two-dose vaccine involving 2268 children had come back with favourable safety and antibody responses.
The pharmaceutical giant is also running a study involving children aged six months up to five years, which should produce results by the end of this year.
