Moderna has initiated the filing of a rolling New Drug Submission to Health Canada for its updated monovalent COVID-19 vaccine, SPIKEVAX XBB.1.5 targeting the omicron subvariant XBB.1.5 of SARS-CoV-2. This follows Moderna’s submission to the U.S. Food and Drug Administration for authorization. This is in alignment with 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. The company is prepared to deliver updated COVID-19 vaccines in time for the fall vaccination season.
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