TGA provisionally approves Moderna’s COVID-19 vaccine for use as a booster dose in individuals 12 years and older

On 19 October 2022, the Therapeutic Goods Administration (TGA) provisionally approved Moderna's COVID-19 vaccine, SPIKEVAX (elasomeran), for use as a booster dose in individuals aged 12 years and older.

This mRNA vaccine is already provisionally approved for immunisation to prevent COVID 19 in individuals aged 6 months and older and as a booster dose for adults aged 18 years and older.

In making this decision, the TGA carefully considered data from an ongoing clinical study. The booster phase of the study, which included over 1,300 participants aged 12 to 17 years, demonstrated that the immune response to the booster was similar to that seen in young adults aged 18 to 25 years. The safety profile in individuals aged 12 to 17 years was similar to that seen in young adults with no new safety concerns.

The decision to provisionally approve the vaccine was informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation. The Australian Public Assessment Report (AusPAR) for this decision will be published in the coming days.

The Government's decision on the use of this vaccine in this age group will be informed by advice from the Australian Technical Advisory Group on Immunisation (ATAGI).

Contact for members of the media:

• Email: news@health.gov.au
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