Moderna says Japan regulator has approved partial change to NDA for its omicron-targeting COVID booster

Moderna Inc. said Monday the Japanese regulator has approved a partial change to its new drug application for its omicron-targeting COVID booster, MRNA-1273.214. The approval from the Ministry of Health, Labour and Welfare is based on data from a Phase 2/3 trial in which the booster met all primary endpoints, including superior neutralizing antibody response against omicron compared to the currently approved dose of Spikevax in previously uninfected trial participants. It increased neutralizing antibodies by about eightfold above baseline levels and showed higher antibodies against BA.4 and BA.5, the two variants that are now dominant, compared with Spikevax. Moderna has now received authorization decisions for its omicron-targeting booster in the U.S. Australia, Canada, Europe, Switzerland, South Korea, Taiwan and the U.K. Shares were flat premarket but are down 34% in the year to date, while the S&P 500 has fallen 15%.

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