On August 30, Moderna announced that the Australian Therapeutic Goods Administration (TGA) has approved the marketing of the new crown booster vaccine mRNA-1273.214 for adults 18 years of age and older.
mRNA-1273.214 is a 2-in-1 bivalent vaccine against the original strain, Omicron variant BA.4/5 and BA.1 subtypes simultaneously.
The approval is based on positive data from a Phase II/III clinical trial, with mRNA-1273.214 meeting all primary endpoints. The results showed that mRNA-1273.214 had a better neutralizing antibody response to Omicron BA.1. In subjects who were seronegative at baseline, the geometric mean neutralizing titers for Omicron at the mRNA-1273.214 booster dose increased approximately 8-fold from baseline. In addition, mRNA-1273.214 produced potent neutralizing antibody responses to both Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273).
The reactogenicity and safety profile of mRNA-1273.214 is consistent with the currently licensed Spikevax (mRNA-1273) booster.
Moderna Chief Commercial Officer Alpa Garret said: “We are delighted that the TGA has approved the bivalent vaccine mRNA-1273.214. Australia has become one of the first countries in the world to approve a vaccine containing Omicron, underscoring Australia’s role in the fight against COVID-19 Continued leadership is an important step in helping protect the Australian people from the ongoing threat to global public health from COVID-19.”