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.
Write to Chris Wack at chris.wack@wsj.com
