TGA provisional determination for Moderna’s COVID-19 bivalent booster dose vaccine

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The TGA has granted a provisional determination to Moderna’s bivalent COVID-19 vaccine candidate.

The vaccine, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4/BA.5 (elasomeran and davesomeran), comprises mRNA for both the original and Omicron BA.4/5 strains. It is proposed for use as a booster to prevent COVID-19.

The provisional determination means Moderna can apply for provisional registration of the bivalent vaccine. The company has six months to submit a registration application.

The regulator said that if an application for provisional registration is made, Moderna must also submit data from human clinical trials before any decision to provisionally approve the product can be made. 

On 29 August 2022, the TGA provisionally approved a separate Moderna bivalent COVID-19 vaccine, comprising the comprising mRNA for the original and Omicron BA.1 strains (elasomeran/imelasomeran or SPIKEVAX Bivalent Original/Omicron) for use as a booster dose in adults.