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

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.
  • Photo via Wikimedia Commons

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