Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, announced that it has filed for authorization with Health Canada for its 2024-2025 Formula COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. The submission follows the National Advisory Committee on Immunization (NACI) guidance to use the latest selected strain and the guidance from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and World Health Organization (WHO).1-4
Nonclinical data have demonstrated that Novavax’s updated COVID-19 vaccine induces broad neutralization responses to JN.1 lineage viruses, including those containing the F456L and R346T mutations, to „FLiRT“ variants and to „FLuQE“ variants such as KP.3.4-6 Novavax’s vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a wide range of JN.1 lineage variants.4 These responses indicate that Novavax’s vaccine technology induces broadly neutralizing responses against multiple variant strains, including responses to circulating forward drift variants.
Novavax intends to have its vaccine available in Canada for immediate release post-authorization, should public health programs choose to provide this option. Novavax has filed with the U.S. FDA and EMA, and is working with other regulatory authorities globally on authorization or approval of its updated COVID-19 vaccine.
NVX-CoV2705 is an updated version of Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax’s unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax’s Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.
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