The TGA has provisionally approved Moderna's mRNA COVID-19 vaccine with the federal government saying it expects that the first one million doses will be delivered in the second half of September.
It is the fourth COVID-19 vaccine granted provisional approval by the TGA, following those developed by Pfizer, AstraZeneca and Janssen.
The regulator approved the vaccine - SPIKEVAX (elasomeran) - for the prevention of COVID-19 in people 18 years of age and older. It said the vaccine is given in two doses that are administered 28 days apart.
In announcing the approval, Prime Minister Scott Morrison said the first one million doses scheduled for delivery in September will be administered through community pharmacies. He also said the government then expects three million doses to be delivered in each of October, November and December.
Under the agreement, Australia will also receive an additional 15 million doses of the company's future vaccines targeting new variants of COVID-19.
The public stated and definitive delivery schedule for a vaccine experiencing production issues outside the US has put the onus on the company. It enables the government to shift blame to the company if there is any delay in the delivery.
Moderna has reported production issues at its facilities outside the US. The company recently delayed the delivery of vaccine doses to South Korea. The country has a contract for 40 million doses of the Moderna vaccine with around 1.1 million delivered at the end of July.
"The Moderna COVID-19 vaccine has shown strong efficacy preventing symptomatic COVID-19 and severe COVID-19 in clinical trials," said the TGA in a statement announcing its approval.
"The vaccine has also received regulatory approval or emergency authorisation in several countries and is being widely used in the United Kingdom, Canada, the European Union, the United States, Switzerland and Singapore."
The regulator said the approval is subject to certain conditions, including a requirement for Moderna to continue providing information on longer-term efficacy and safety from ongoing clinical trials and post-market assessment. It also said it is currently evaluating data supporting the use of Moderna's vaccine in adolescents aged 12 to 17 years and "no specific concerns have been identified to date."
"The TGA’s decision on use in this age group will be announced separately," it said.
Pharmacy national president Trent Twomey said its members are ready to further help build momentum in the vaccination rollout.
“We welcome this action by the Therapeutic Goods Administration and look forward to Moderna approval for Australians aged 12 years and over, before it becomes available in pharmacies in about six weeks’ time,” said Mr Twomey.
“We need to have it approved for adolescents from the get-go. There is ample data to answer both safety and efficacy questions,” he said.