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TGA Provisional Approval of Moderna COVID-19 vaccine to include 12-17 years age group

4 September 2021

The Therapeutic Goods Administration (TGA) has provisionally approved the use of the Moderna Australia Pty Ltd COVID-19 vaccine SPIKEVAX (elasomeran) in individuals 12 years and older. This decision follows the provisional approval granted by the TGA to Spikevax on 9 August 2021 for use in individuals aged 18 years and older.

The recommended dose and dose interval is the same as that for the adult population - two full doses given 28 days apart. Further information is available in the Product Information (PI)

Provisional approval for use in the 12-17 years age group has been made following careful evaluation of the available data supporting safety and efficacy. The vaccine has also received regulatory approval or authorisation in this age group in several jurisdictions, including the United Kingdom, Canada, the European Union and Switzerland.

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

The decision to provisionally approve the vaccine for use in this age group was 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 the decision to use SPIKEVAX in this age group, 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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