Japan approved partial change to a NDA for Omicron-targeting bivalent booster COVID-19 vaccine

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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.

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Source: Moderna
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