Moderna vaccine granted provisional TGA approval for use in Australia

Prime Minister Scott Morrison says 10 million Moderna vaccines will arrive by the end of the year. Picture: Keegan Carroll
Prime Minister Scott Morrison says 10 million Moderna vaccines will arrive by the end of the year. Picture: Keegan Carroll

A new COVID-19 vaccine will be available to Australians next month after the Moderna jab was given the green light in Australia.

The Therapeutic Goods Administration on Monday granted the vaccine provisional approval for use in Australia for people aged 18 or above, with 1 million doses to be sent to pharmacies in September.

The US-made Moderna will complement the AstraZeneca and Pfizer jabs already being administered across Australia. It will require two doses only 28 days apart.

Australia has ordered a total of 25 million Moderna doses, and Prime Minister Scott Morrison on Monday said 10 million were expected to arrive by the end of the year.

"We'll have it in our hands and we will have the jabs in our arms starting next month. This is our plan to ensure that we get Australia to where we need to get to this year," he said.

"We have more Pfizer, we have more AstraZeneca. Now, we have Moderna."

The prime minister revealed 3 million doses would arrive each month between October and December, while the remaining 15 million would be delivered throughout 2022.

But international supply chains have been stretched, as South Korea revealed its expected Moderna intake this month had been more than halved from 8.5 million doses.

And after the early stages of Australia's rollout were plagued by Pfizer under-supply, Health Minister Greg Hunt insisted his expectations had been confirmed in recent days.

Moderna's COVID-19 vaccine has been granted provisional approval by the Therapeutic Goods Administration. Picture: Getty Images

Moderna's COVID-19 vaccine has been granted provisional approval by the Therapeutic Goods Administration. Picture: Getty Images

"As late as the weekend, the advice from Moderna to me directly was that we're expecting 1 million in the second half of September," he said.

"We are constantly, with all of our suppliers, checking and pushing to bring forward. That advice was provided over the weekend."

Mr Hunt claimed, with an uptick in Pfizer arrivals, the government would administer 2 million doses this week. He said there were 676 pharmacies ready to administer vaccines this week, rising to over 2500 in a fortnight.

Moderna was already widely administered across the globe, having been granted approval in over 60 countries, and has shown signs of long-term efficacy.

The TGA's John Skerritt said that included a 93 per cent protection against infection, a near-total protection against serious disease, and 100 per cent effectiveness against death.

"It is exciting to see such sustained activity of that vaccine six months [later]," he said.

Only 28 days are needed between the first and second Moderna doses.

The TGA confirmed work was also under way to assess the vaccine's effectiveness in the 12-to-17 age range, and "no specific concerns have been identified to date".

The EU's medicine agency approved Moderna for anyone aged 12 or over last month.

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"The data on the teenagers does look good and we should be able to make a decision again convening the expert advisory committee within the next three or four weeks on an application for use in 12 and over," Professor Skerritt said.

Moderna was also interested in testing its efficacy in children as young as six months, but Prof Skerritt confirmed there was no application to run a trial including children in Australia.

Labor health spokesman Mark Butler hoped the development would accelerate Australia's sluggish rollout, but accused the government of complacency throughout the negotiation period.

"We welcome that arrival, we've been calling for it for months and months now. But Scott Morrison was too slow to act consistently, with his approach all along [being] that this vaccine rollout was not a race," he said.

Australia's vaccine rollout was significantly dented by ATAGI advice against administering the AstraZeneca jab to people aged under 60 where possible.

AstraZeneca had been set to make up the bulk of the national rollout, and was the only jab set to be produced onshore.

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This story Moderna vaccine granted TGA approval first appeared on The Canberra Times.

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