- Switzerland's regulatory authority has granted conditional approval for Moderna Inc's (NASDAQ: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.
- Photo via Wikimedia Commons
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