CANBERRA, AAP – Pharmaceutical giant Pfizer has taken the first steps to have its COVID-19 vaccine approved in Australia for children aged five to 12.
But Health Minister Greg Hunt says there is still some work to be done for Pfizer to get the “double green light”.
A Pfizer spokeswoman told AAP trial results had shown a favourable safety profile and robust antibody response for two doses of its vaccine.
The data has gone to United States regulators for initial review. A formal submission for emergency use authorisation, along with submissions to other regulatory authorities, are planned in the coming weeks.
Pfizer has applied to Australia’s Therapeutic Goods Administration for a provisional determination, which will allow formal application for inclusion of the five to 11-year-old age group.
As well, a study covering children aged six months to five years old is expected to report back before the end of the year.
Mr Hunt said Australia had secured enough doses to vaccinate five to 12-year-olds if approval is granted.
But he noted it would need the approval of both the TGA, in terms of safety and efficacy, as well as the Australian Technical Advisory Group on Immunisation about use.
“Our approach has always been that we see this as a double green light,” Mr Hunt said.
Australia’s vaccination rollout continues to motor ahead after a sluggish start, with more than two million doses administered in the past week.
Mr Hunt said all states and territories had enough vaccine supply to meet demand for the next month.
“My understanding is that there’s spare capacity for bookings in every state and territory,” he said.
Despite fears jab rates may taper off, the program is maintaining pace with almost 83 per cent of over-16s having received at least one dose.
About 1.3 million doses are needed to lift second-jab coverage from 63.4 to 70 per cent.
More than 53 per cent of children aged 12 to 15 have received a first jab just four weeks after the age cohort was added to the rollout.
There remains pockets of concern with Western Australia and Queensland trailing the nation, and the Northern Territory losing momentum.
The NT is struggling with vaccine hesitancy, fuelled by misinformation.
Local cases in Victoria fell for a second consecutive day, with 1466 new coronavirus infections and eight deaths.
Another 360 people tested positive and five people died in NSW.
There were 28 new cases in Canberra, which will exit lockdown on Friday.