On Sept. 29, 2022, Moderna announced that the European Medicines Agency (EMA) had accepted a variation for the evaluation of a 50 ﾵg booster dose of the Omicron-containing bivalent COVID booster candidate, mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) in adults 12 years and older.

Moderna filed the application based on preclinical findings for mRNA-1273.222 and results from the Phase II/III clinical trial of a bivalent booster shot targeting the Omicron BA.1 subvariant, mRNA-1273.214.

The latest submission comes after the company received approval for mRNA-1273.214 this month.

Moderna has so far obtained authorisations for Omicron-targeting bivalent booster vaccine in the US, Canada, Europe, Australia, South Korea, Switzerland, Japan, Singapore, Taiwan and the UK.

The company is also seeking regulatory approvals across the globe.