Moderna Says Japan Approved Partial Change To NDA For Its Omicron Booster

Moderna, Inc. (MRNA) on Monday said Ministry of Health, Labour and Welfare (MHLW) in Japan has approved a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, MRNA-1273.214.

The approval from the MHLW is based on data from a Phase 2/3 study, in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron when compared to the currently authorized booster dose of Spikevax in previously uninfected participants.

A booster dose of MRNA-1273.214 increased neutralizing antibodies against Omicron by 8-fold above baseline levels, and showed higher antibody titers against the Omicron subvariants BA.4 and BA.5 when compared to Spikevax.

Moderna has already received authorization decisions for Omicron-targeting bivalent boosters in the United States, Australia, Canada, Europe, Switzerland, South Korea, Taiwan, and the UK to date and has completed regulatory submissions worldwide.

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