Moderna announced that it has submitted a regulatory application to the European Medicines Agency, or EMA, for its updated COVID-19 vaccine encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2. “The application is based on guidance from the European Centre for Disease Prevention and Control and the EMA, which recommended that COVID-19 vaccines be updated to a monovalent XBB.1.5 composition. This aligns with other regulators and global public health agencies recommending a monovalent XBB.1.5 composition. Additionally, Moderna has generated preliminary clinical data of its monovalent XBB.1.5 vaccine candidate showing an immune response against XBB descendent sublineages such as XBB.1.5, XBB.1.16, and XBB.2.3.2. Moderna is in the process of submitting data to regulators worldwide to advance its updated COVID-19 vaccine in time for the autumn/winter vaccination season and has recently filed with the U.S. Food & Drug Administration, Health Canada, and other health authorities,” the company stated.
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