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Swissmedic Authorizes Moderna’s Omicron-targeting Bivalent Booster Candidate, mRNA-1273.214

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Swissmedic Authorizes Moderna’s Omicron-targeting Bivalent Booster Candidate, mRNA-1273.214 | Pharmtech Focus

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic has granted temporary authorization for the use of Moderna’s Omicron-targeting bivalent booster vaccine, Spikevax Bivalent Original/Omicron (mRNA-1273.214) for active immunization to prevent SARS-CoV-2 virus-induced Coronavirus-2019 disease for individuals aged 18 years and older. Spikevax Bivalent Original/Omicron 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).

“We are delighted to receive authorization from Swissmedic for our next-generation bivalent vaccine, mRNA-1273.214. This is another example of Switzerland’s continued leadership in helping to end the COVID-19 pandemic,” said Arpa Garay, Chief Commercial Officer at Moderna. “Moderna is proud to play a key role in helping to protect the people of Switzerland from the ongoing threat that COVID-19 represents to global public health.”

The decision from Swissmedic is based on clinical trial data from a Phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to the currently authorized 50 µg booster dose of Spikevax (mRNA-1273) 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. mRNA-1273.214 was generally well tolerated, with a reactogenicity and safety profile consistent with the currently authorized booster.

Moderna is working with Swissmedic and the Government of Switzerland to make Spikevax Bivalent Original/Omicron available to people in Switzerland, with the aim of supplying product in early September. Moderna has received approval for mRNA-1273.214 in the UK and has completed regulatory submissions for the next-generation vaccine worldwide.

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