By Chris Wack
Moderna Inc. said Thursday that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization for Spikevax bivalent Original/Omicron BA.1.
The company's next-generation Spikevax bivalent Original/Omicron BA.1 vaccine candidate contains mRNA-1273 and targets the Omicron variant of concern.
Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of mRNA-1273.214 as a booster dose for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals 12 years of age and older, who have previously received at least a primary vaccination course against Covid-19.
The decision from the CHMP 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 when compared to the currently authorized 50 microgram booster dose of Spikevax in previously uninfected participants.
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