Moderna has obtained temporary authorisation from Swissmedic for its Omicron-targeting bivalent booster vaccine for Covid-19, Spikevax Bivalent Original/Omicron (mRNA-1273.214), for individuals aged 18 years and above.
The vaccine is indicated for active immunisation for the prevention of Covid-19.
It comprises 25µg mRNA-1273 (Spikevax) and 25µg of a vaccine candidate that acts on the Omicron variant of concern (BA.1).
The approval is based on findings from the Phase II/III clinical trial of the mRNA-1273.214 vaccine.
According to the study data, the trial met all primary endpoints.
In previously uninfected subjects, the bivalent vaccine showed a greater neutralising antibody response against Omicron (BA.1) versus the 50µg booster dose of Spikevax authorised presently.
In the trial, mRNA-1273.214 was found to be well tolerated with a reactogenicity and safety profile in line with the booster authorised presently.
With the latest authorisation, Switzerland became one of the first countries globally to approve this next-generation bivalent booster vaccine for Covid-19.
The company is collaborating with Swissmedic and the Government of Switzerland to supply the mRNA-1273.214 vaccine to people in the country by early September this year.
Moderna chief commercial officer Arpa Garay said: “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.
“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.”
Before this development, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional authorisation for this vaccine to adults aged 18 years and older.
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