Switzerland Approves First Next-Generation Bivalent COVID-19 Booster Vaccine

Switzerland's regulatory authority has granted conditional approval for Moderna Inc's MRNA omicron-targeting bivalent booster vaccine for adults 18 years and older.
Spikevax bivalent is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.1).
Related: Moderna Plans US Application Submission For COVID-19 Omicron Adapted Booster 'Very Soon.'
The decision is based on clinical trial data from a Phase 2/3 trial, in which mRNA-1273.214 showed a superior neutralizing antibody response against omicron (BA.1) compared to the currently authorized 50 µg booster dose in previously uninfected participants.
A booster dose of Spikevax Bivalent Original/Omicron (mRNA-1273.214) increased neutralizing geometric mean titers (GMT) against omicron approximately 8-fold above baseline levels.
In addition, Spikevax Bivalent Original/Omicron (mRNA-1273.214) elicited higher neutralizing antibody titers against the omicron subvariants BA.4 and BA.5 when compared to Spikevax (mRNA-1273) regardless of prior infection status or age, including in those aged 65 and older.
Moderna is working with Swissmedic and the Government of Switzerland, intending to supply the product in early September.
Price Action: MRNA shares are up 0.90% at $137.96 on the last check Monday.
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