Posted by Michael Wonder on 28 Apr 2022
TGA grants provisional determination for the Moderna bivalent COVID-19 vaccine "Spikevax Bivalent Zero/Omicron"
28 April 2022 - On 27 April 2022, the TGA granted a provisional determination to Moderna in relation to its bivalent COVID-19 vaccine, elasomeran/elasomeran 0-omicron (Spikevax Bivalent Zero/Omicron).
Currently, Moderna has provisional approval for its COVID-19 vaccine, Spikevax, for use in individuals aged 6 years and older. This mRNA vaccine (mRNA-1273) is based on the original ("wild type") SARS-CoV-2 spike glycoprotein.
With the emergence of COVID-19 variants of concern, Moderna has developed a bivalent vaccine that includes the mRNA sequence encoding the spike protein of the Omicron variant of concern and the same mRNA-1273 backbone as in the original Spikevax vaccine.
