FACTBOX-What Australia's first vaccine nod means for national rollout

by Reuters
Monday, 25 January 2021 04:45 GMT

SYDNEY, Jan 25 (Reuters) - Australia has taken a cautious approach to approving coronavirus vaccines, a sharp contrast to the rapid, emergency rollouts seen in nations harder hit by the pandemic.

On Monday, the country's Therapeutic Goods Administration (TGA) gave provisional approval for the vaccine produced by Pfizer Inc and partner BioNTech SE with the first shots expected in late February.

Here's what the approval means for Australia's vaccination plan:

*WHAT ARE THE ARRANGEMENTS FOR A VACCINE?

Australia has taken a diversified approach to COVID-19 vaccines, with 140 million shots initially on order -- enough for several times the population -- to ensure flexibility.

The country has 53 million doses of AstraZeneca's Oxford vaccine on order, of which 50 million will be made domestically by CSL.

It also has 10 million doses ordered from Pfizer-BioNTech, enough for five million people since it requires two shots.

Australia has an arrangement for 51 million doses of an offshore-manufactured vaccine still being trialled by Novavax Inc.

An earlier order for 51 million doses of a vaccine developed by Australia's University of Queensland, which was to be produced by CSL, was scrapped in December after trials showed it could interfere with HIV diagnosis.

*WHY THE LAG?

Australian authorities say most vaccine approvals globally have been on an emergency basis, meaning manufacturers must still commit to handing over safety and efficacy data to regulators once rolled out.

While other countries began issuing emergency approvals in December, Australian officials argue very low local community transmissions mean it can afford to wait until it has enough trial data before approving any vaccines for domestic use.

*WHAT'S THE LATEST WITH APPROVALS?

The Pfizer-BioNTech product is the first COVID-19 vaccine to receive approval for use in Australia. The provisional nod is a more comprehensive approval than those issued for emergency use and means the product can be sold for two years.

The TGA says the approval means Australians can be confident that the review process "was rigorous and of the highest standard."

The Australian government expects the TGA to give approval for the AstraZeneca vaccine in the next few weeks, ahead of a rollout that's expected to start in March.

The Pfizer approval means a rescheduling of Australia's original vaccine plan.

The country initially committed to underwriting a domestic manufacturing plant for biopharmaceutical giant CSL Ltd to make tens of millions of doses of AstraZeneca's "Oxford" vaccine.

But that vaccine hasn't received domestic approval yet, leaving a limited order of the Pfizer product, enough for a fifth of the country's 25 million people, to get the programme started.

*WHAT IS AUSTRALIA'S EXPOSURE TO GLOBAL SUPPLY SHORTAGES AND SHIPPING DELAYS?

Australia says it has been assured delivery of its Pfizer vaccines before rollout begins in late February.

Health Minister Greg Hunt says the government has been notified by AstraZeneca that it is managing a "supply shock" globally, and this will delay delivery of its 3 million offshore-produced doses.

He says Australia will bring forward delivery of its 50 million domestically manufactured AstraZeneca doses, ensuring the programme is unaffected.

*WHAT HAPPENS NOW?

The government has said it wants 80,000 people vaccinated per week. The vaccine is approved for everyone over the age of 16 although a final priority list is still being drawn up and authorities expect to work with hospitals and general practitioners to co-ordinate a rollout.

Health Secretary Brendan Murphy says there is not enough data available to determine the vaccine's safety for pregnant women so authorities will use a "best guess" about whether to administer it to them. For elderly and frail patients, "very careful clinical" decisions would be needed, Murphy said.

(Reporting by Byron Kaye; Editing by Sam Holmes)

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