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

On 17 February, the Therapeutic Goods Administration (TGA) granted provisional approval to Moderna’s bivalent COVID-19 vaccine: elasomeran and davesomeran (SPIKEVAX Bivalent Original/Omicron BA.4-5) for use as a booster dose in individuals aged 12 years and older. 

This is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that has been provisionally approved by the TGA and follows provisional approval of Pfizer’s COMIRNATY BIVALENT Omicron BA.4/BA.5 COVID-19 vaccine on 20 January 2023. 

The TGA carefully considered data from an ongoing Phase II/III study, which showed that the vaccine elicited a superior neutralising antibody response against the Omicron BA.4/BA.5 strain compared to the original (monovalent) SPIKEVAX vaccine. The vaccine also elicited a good neutralising antibody response against a number of other currently circulating and emerging variants.

Evidence from extensive use in Canada, Europe, Japan and the US over recent months has also shown that this booster provides clear reductions in hospitalisation and death. Additionally, the US Centers for Disease Control (CDC) has reported that early safety findings found that this vaccine has a similar safety profile to the original SPIKEVAX booster.

The decision to approve SPIKEVAX Bivalent Original/Omicron BA.4-5 was informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields and including consumer representation. The potential use of this vaccine in the national COVID-19 vaccination program is still to be determined. The Australian Technical Advisory Group on Immunisation (ATAGI) will provide advice to the Government on these matters in coming weeks.

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