On Oct. 31, 2022, Moderna announced that it had received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222 (Spikevax Bivalent Original/Omicron BA.4-5) in adults 18 years and older. Spikevax Bivalent Original/Omicron BA.4-5 contains 25 ﾵg of mRNA-1273 (Spikevax) and 25 ﾵg of a vaccine candidate targeting the Omicron variant BA.4-5. mRNA-1273.222 now joins Moderna’s BA.1 variant targeting vaccine, mRNA-1273.214, which was approved in Japan in September.

Moderna developed mRNA-1273.222 in accordance with U.S. FDA guidance to develop a BA.4-5-targeting bivalent vaccine. A Phase 2/3 trial for mRNA-1273.222 is currently underway. Takeda Pharmaceutical Co. Ltd. continues to provide distribution support for Spikevax Bivalent Original/Omicron BA.4-5 under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period.

Spikevax Bivalent Original/Omicron BA.4-5 is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. One 0.5 mL dose is provided intramuscularly.