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TGA provisionally approves Moderna's COVID-19 vaccine

9 August 2021

On 9 August 2021, the Therapeutic Goods Administration (TGA), part of the Department of Health, granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine - Spikevax (elasomeran) - making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.

This messenger RNA (mRNA) vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. It is recommended that the vaccine is given in two doses that are administered 28 days apart.

The Moderna COVID-19 vaccine has shown strong efficacy preventing symptomatic COVID-19 and severe COVID-19 in clinical trials. 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.

Provisional approval of this vaccine in Australia is subject to certain strict conditions, such as the requirement for Moderna Australia Pty Ltd to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Data to support the use of Moderna's COVID-19 vaccine in adolescents aged 12 to 17 years are currently under evaluation and no specific concerns have been identified to date. The TGA's decision on use in this age group will be announced separately.

The Australian Government has secured 25 million doses of Spikevax (elasomeran) to further diversify Australia's vaccine portfolio as well as provide access to a booster or variant vaccine should this be required in the future. The agreement includes the supply of 10 million doses of Spikevax (elasomeran) in 2021 and of 15 million doses of Moderna's updated variant booster vaccine in 2022. More information about Australia's vaccine agreements can be found on the Department of Health's Australia's Vaccine Agreements webpage.

Spikevax (elasomeran) is the second mRNA vaccine to receive provisional approval in Australia. mRNA vaccines use a synthetic genetic code called RNA to give our cells instructions about how to make the coronavirus' unique spike protein. When our body has made the protein encoded by the mRNA vaccine, it then recognises the spike protein as being foreign and launches an immune response against it. The RNA from the vaccine does not change, or interact, with our DNA in any way.

Australians can be confident that the TGA's review process of Spikevax (elasomeran) was rigorous. The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.

The TGA will continue to actively monitor the safety of Spikevax (elasomeran) and will not hesitate to take action if safety concerns are identified.

The TGA has published a series of regulatory documents that relate to this decision, including the Australian Public Assessment Report (AusPAR), Product Information and the decision summary, which provide details about the evidence that the TGA reviewed to support the provisional approval of the vaccine.

Further information on the COVID-19 vaccine rollout is available on the Department of Health website.

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