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TGA paves way for under-fives vaccine

Australia is a step closer to having COVID-19 vaccinations for children aged six months to five years, with Pfizer approved to submit an application with the medical regulator.

The Therapeutic Goods Administration has granted a provisional determination to Pfizer, which would allow the pharmaceutical giant to apply to extend vaccine use to the younger cohort.

Currently, the Pfizer vaccine has been approved for those aged five and over but there has been talk of extending its use to younger children, after US regulators recently approved a similar move.

A spokesman for the TGA said the provisional determination was the first step.

“The TGA considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data and the seriousness of the COVID-19 pandemic,” he said.

“Approval and potential supply in Australia would only commence should the vaccine be approved as safe and effective by the TGA and recommended for administration to this age group by ATAGI.”

The Moderna vaccine for children under five is already being considered for approval by the administration.

Health Minister Mark Butler did not want to put an exact timeframe on when a rollout of the pediatric vaccine would be approved.

“The TGA will take the time it needs to take, that’s always been our approach, it was the former government’s approach,” he told reporters in Canberra.

“I’m happy with however long they take to do the job properly.”

Mr Butler said discussions had taken place with Moderna and Pfizer to make sure vaccines were ready to be distributed once they were formally approved.

However, the health minister said it was too early to predict what the take-up rate might be.

“We have a great track record in this country of up-to-five immunisations generally,” he said.

“What the take up will be by parents of under fives is a little unknown, we’ll be considering what support and information we provide to parents about this.”

The TGA said the determination did not mean Pfizer had yet submitted an application, or that it had been approved; only that it had been allowed to apply for expanded use.

Australia is on track to record its 10,000th death from the virus within days.

NSW, Victoria and Queensland together recorded 50 fatalities in the latest 24-hour reporting period, as the national toll rose to 9897.

NSW Health is warning of a rise in cases this winter as new sub-variants take over, making people vulnerable to a second dose.

The BA.2 sub-lineage remains the dominant variant. However, it is expected BA.4 and BA.5 will soon become so and are likely to be associated with an increase in infections.

Meanwhile, vaccinations are no longer mandatory in Queensland for visitors to hospitals, aged care facilities, disability accommodation and jails.

Workers in high-risk settings such as early childhood, primary and secondary education, prisons, youth detention centres, and airports are also exempt, unless required by employers to be vaccinated.


NSW: 11,504 cases, 23 deaths, 1534 in hospital with 37 in ICU

Victoria: 9926 cases, 17 deaths, 465 in hospital with 21 in ICU

Tasmania: 1268 cases, two deaths, 44 in hospital with three in ICU

SA: 3129 cases, no deaths, 237 in hospital with eight in ICU

WA: 5548 cases, seven deaths, 219 in hospital with 11 in ICU

Queensland: 5286 cases, 10 deaths, 631 in hospital with14 in ICU

ACT: 1250 cases, one death, 122 in hospital with two in ICU

Northern Territory: 354 cases, no deaths, 15 in hospital with two in ICU.

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