Moderna COVID-19 vaccine granted ‘provisional determination’ by Therapeutic Goods Administration

The Moderna coronavirus vaccine is one step closer to being approved in Australia, paving the way for AstraZeneca to be phased out in coming months.

The Therapeutic Goods Administration has granted a provisional determination to the company, which the Federal Government has contracted to provide 25 million doses.

Modelling released by the National COVID Vaccine Taskforce yesterday showed the group recommended to get the AstraZeneca jab — people over 60 — was approaching full vaccination.

Under 60s are not recommended to get the AstraZeneca jab because of blood clotting risks, with updated advice recommending they get an mRNA vaccine like Pfizer or Moderna.

Health Minister Greg Hunt announced changes to the vaccine rollout last week, with AstraZeneca no longer recommended for people in their 50s after a number of clotting events in that aged group and the death of a 52-year-old woman.

The new vaccine will be available for Australians aged 12 and over, and given in two doses 28 days apart.

“The granting of a provisional determination means that the TGA has made a decision that Moderna is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods,” the TGA said in a statement.

“Provisional determination is the first step in the process. It is anticipated that Moderna will submit an application for provisional registration shortly. Importantly, registration and supply in Australia will only commence should the vaccine be approved as safe and effective by the TGA.”

The Federal Government’s contract with Moderna includes the supply of 10 million doses in 2021 and of 15 million doses of Moderna's updated variant booster vaccine in 2022.

It will compliment the Pfizer doses, which will start being rolled out by GPs alongside Federal Government-run vaccination sites.

WA is expected to receive a minimum 3.2 million doses of Pfizer by the end of the year, and up to 4.3 million.

With AAP