TGA provisionally approves Moderna’s new bivalent COVID-19 vaccine


The TGA has granted provisional approval to Moderna’s bivalent COVID-19 vaccine, SPIKEVAX (elasomeran and davesomeran), for use as a booster dose in individuals aged 12 years and older.

The regulator said that this is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that it has been provisionally approved. It follows the 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," said the regulator.

"The vaccine also elicited a good neutralising antibody response against a number of other currently circulating and emerging variants."

The TGA said 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," it said.