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Swiss regulator grants temporary authorization for Moderna bivalent COVID booster for adults age 18 and older

Moderna Inc. said Monday the Swiss regulator has granted temporary authorization to its bivalent omicron-targeting COVID booster for use in adults aged 18 and older. “Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains 25 ug of mRNA-1273 (Spikevax) and 25 ug of a vaccine candidate targeting the Omicron variant of concern (BA.1),” the company said in a statement. Swissmedic made the decision based on data from a Phase 2/3 trial showing the booster increased neutralizing antibodies against omicron roughly 8-fold above baseline levels, it added. It also produced higher neutralizing antibody titers against BA.4 and BA.5, which has become the dominant subvariant globally, according to the World Health Organization. Moderna is working to get product to Switzerland by early September. Moderna shares were down 0.6% premarket, and have fallen 46% in the year to date, while the S&P 500 has fallen 11%.

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