• The Moderna COVID-19 vaccine is one step closer to rolling out in Australia after the Therapeutic Goods Administration (TGA) granted it provisional registration.
• The measure is the first step towards full TGA approval, and Moderna is expected to sign up “shortly”.
• The news comes as Australia plans to phase out the AstraZeneca vaccine by the end of the year.
• Visit Business Insider Australia’s homepage for more stories.

Australia is one step closer to having three COVID-19 vaccines approved for use in the national rollout, after the Therapeutic Goods Administration cleared the way for Moderna to seek an official sign-off for its mRNA jab.

But if the formulation gains approval, it is likely to become one of just two vaccines widely offered around Australia at the end of 2021, thanks to the Health Department’s new plan to turn away from the AstraZeneca vaccine.

In a Thursday announcement, Australia’s medicines watchdog granted Moderna a ‘provisional determination’, meaning the door is now open for the US biomedical firm to register its formulation on the Australian Register of Therapeutic Goods.

“It is anticipated that Moderna will submit an application for provisional registration shortly,” the TGA said.

Provisional registration is the first step to fully-fledged approval, as the jab will be subjected to rigorous safety and efficacy testing by the TGA before it is administered across the country.

Moderna has been widely utilised in nations like the United States, where health authorities have deemed the formulation safe and effective at preventing both symptomatic and asymptomatic COVID-19 infections.

Australia has already ordered 25 million doses of the Moderna formulation, and the new National Vaccination Allocation Horizons document, released Wednesday, suggests between 87,500 and 125,000 of those doses could be administered each week from September this year.

The Moderna jab is likely to be administered in primary care settings only, the document states, with the number of doses provided each week reaching as much as 614,600 a week between October and December.

The same document suggests the Moderna vaccine will be used to pick up some of the slack left by the AstraZeneca vaccine, which will largely be phased out over the course of the year.

Despite originally forming a cornerstone of Australia’s vaccine rollout plan, The Australian Technical Advisory Group on Immunisation last week recommended the AstraZeneca formulation only be used for those aged sixty and over, due to its links to an vanishingly rare blood clotting side effect.

The National Vaccination Allocation Horizons document suggests AstraZeneca usage will taper off to the end of the year as the immunisation rate in those aged over 60 increases. By October, it is expected AstraZeneca doses will be made available to state and primary care immunisation centres by request only.

The Pfizer vaccine, the first rolled out in Australia, will continue to be utilised. The paper forecasts as many as 2.3 million doses of the Pfizer formulation will be administered in state and primary care settings each week in the final months of the year.

The document makes no mention of Novavax, which signed a deal to provide Australia with 51 million doses, but has been hit by significant production delays.

News of both Moderna’s provisional registration and the National Vaccination Allocation Horizon roadmap come as Australia’s vaccine rollout falls well behind its original and revised schedule.

As of Wednesday, just under seven million COVID-19 vaccine doses have been administered nationwide.

As flagged by the 2021-2022 federal budget, the federal government’s most recent goal is to open vaccine access to every Australian by the end of the year.

Rolling the Moderna jab into Australia’s vaccine mix seems likely to support that effort.

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