TORONTO – Moderna, Inc, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, has announced that it has initiated the filing of a rolling New Drug Submission (NDS) to Health Canada for its updated monovalent COVID-19 vaccine, SPIKEVAX® XBB.1.5 (mRNA1273.815) 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.“As the COVID-19 virus evolves, so must the vaccines. An updated vaccine will ensure Canadians have the most current and effective option to keep them protected. We have initiated our submission with Health Canada and, pending approval, will be ready to supply an XBB monovalent vaccine in time for the fall,” said Patricia Gauthier, President and GM, Moderna Canada.
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
