AstraZeneza virus vaccine approval nears

Rebecca Gredley
·2-min read

Officials are expecting the AstraZeneca coronavirus vaccine to receive approval by the middle of February.

Therapeutic Goods Administration head John Skerritt said Australian regulators were sending AstraZeneca a series of questions about its vaccine, with the company expected to respond within two weeks.

Approval will be given based on the information provided.

Professor Skerrit said the focus would then be on locally manufacturing the vaccine, with authorities hoping that approval is complete by mid-March.

He said Australia had benefited from watching vaccination rollouts in the UK and the US, as any rare but severe reactions occur about four to eight weeks after someone has had the medicine.

There's been no evidence of any events, Professor Skerritt said.

Australia's approval process for the coronavirus vaccine has taken centre stage at a parliamentary inquiry on Friday, after Health Minister Greg Hunt initiated it last August.

The government is acutely aware of the unprecedented public interest in the coronavirus vaccine's development and approvals.

Australia has secured more than 150 million doses of various vaccines.

That includes almost 54 million doses of the AstraZeneca vaccine, with the vast majority to be manufactured in Melbourne, and more than 51 million from Novavax.

The federal government this week struck a deal for 10 million more doses of the Pfizer vaccine, doubling the supply.

Clinical trials have found it 95 per cent effective after two shots, with the first Australians on track to receive the drug later this month.

Elderly and vulnerable people will be the first to receive the jab along with frontline health, border and quarantine workers, with the aim of vaccinating most Australians by October.

Authorities are working on a website where all Australian can check when they're eligible for the vaccine and where they can get it.

Department of Health boss Brendan Murphy said Australia has had the luxury of planning, unlike the UK and the US.

"They really had to just roll out and build the plane as it was flying."

The Pfizer vaccine comes in vials with six doses.

Medical workers have to undertake specific training for multi-dose vials before being allowed to administer the jab.

Clinics will have to make sure they have enough patients in order to use each full vial, to ensure doses aren't wasted.

Officials will track wastage and if a clinic has high rates, they may not be allowed to continue providing coronavirus vaccines.

Novavax has announced the start of a "rolling review process" for the authorisation of its vaccine by agencies in Europe, the UK, US and Canada as it completes phase three trials in the UK and US.

Deputy Opposition Leader Richard Marles is reluctant to praise government efforts in sealing vaccine deals.

"There hasn't been a vaccine - no one has been vaccinated yet - so the proof is going to be in the pudding down the road," he told Nine.