Provisional approval for Moderna's COVID-19 bivalent Spikevax in Australia

20 February 2023

Australian medicines regulator the Therapeutic Goods Administration (TGA) has granted provisional approval to US messenger RNA (mRNA) specialist Moderna’s (Nasdaq: MRNA) 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 (NYSE: PFE) Comirnaty bivalent Omicron BA.4/BA.5 COVID-19 vaccine on January 20, 2023.

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

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