Moderna files for FDA authorization for updated COVID-19 vaccine

Moderna “announced that it has completed submission of a regulatory application to the U.S. Food and Drug Administration for its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2. The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition. This is in alignment with other regulators and global public health agencies who have likewise recommended a monovalent XBB composition. At the recent VRBPAC, Moderna was the only company to submit preliminary clinical data comparing monovalent and bivalent vaccines and showing robust human immune responses across multiple XBB descendent sublineages such as XBB.1.5, XBB.1.16 and XBB.2.3.2.”