TGA grants provisional determination to Moderna’s COVID-19 bivalent (Original plus Omicron BA.4/BA.5) booster dose vaccine

On 28 September 2022, the Therapeutic Goods Administration (TGA) granted a provisional determination to Moderna Australia Pty Ltd’s bivalent COVID-19 vaccine candidate: elasomeran and davesomeran (SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4/BA.5). The vaccine comprises mRNA for both the original and Omicron BA.4/5 strains and is for proposed use as a booster for active immunisation to prevent COVID-19.

The new provisional determination means that Moderna Australia Pty Ltd is now able to apply for provisional registration of this bivalent vaccine. Granting of the provisional determination precedes the provisional registration application and does not guarantee approval. Moderna has six months during which time a registration application must be submitted.

If an application for provisional registration is made, Moderna must also submit data from human clinical trials to the TGA before any decision to provisionally approve the product could be made. This is a legal requirement for the provisional approval of any vaccine or any other medicine in Australia.

Note that 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. Initial analysis showed that this bivalent vaccine generated a higher immune response against sub-variants BA.4 and BA.5 than the original SPIKEVAX vaccine.

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