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Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, 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.
Spikevax bivalent Original/Omicron is indicated for active immunization to prevent SARS-CoV-2 virus-induced Coronavirus-2019 disease for individuals aged 18 years and older.
In over 10 years since its inception, Moderna has transformed from a science research-stage company advancing programmes in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.
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