Novavax Applies to FDA for 2024-2025 Protein-based COVID-19 Vaccine

Novavax, Inc., a global leader in protein-based vaccine development, has recently submitted an amendment to its Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA). This amendment is for its updated JN.1 COVID-19 vaccine, NVX-CoV2705, intended for individuals aged 12 and older. This submission aligns with the global guidelines from the FDA, the European Medicines Agency (EMA), and the World Health Organization (WHO), all of which recommend targeting the JN.1 lineage for the upcoming vaccination season.

The updated JN.1 vaccine by Novavax demonstrates broad cross-neutralizing antibodies against various variant strains, including KP.2 and KP.3. This suggests the vaccine's potential to offer protection against forward drift variants. Recent discussions at the FDA's Vaccines and Related Biological Products Advisory Committee highlighted the public health benefits of targeting the JN.1 strain, which is the progenitor of the most common currently circulating variants.

John C. Jacobs, President and CEO of Novavax, emphasized the company's commitment to providing a protein-based COVID-19 vaccine option at the start of the vaccination season. He noted that research indicates offering vaccine choices, combined with healthcare provider recommendations, could enhance vaccination rates.

Nonclinical data show that the JN.1 vaccine induces broad neutralization responses against JN.1 lineage viruses, including those with F456L and R346T mutations, and other variants like "FLiRT" and "FLuQE." The vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to various JN.1 lineage variants. This highlights the vaccine's potential efficacy in targeting the parent strain of KP.2 and KP.3.

Novavax plans to have its vaccine doses ready for distribution in the U.S. by mid-August. Following FDA authorization and a recommendation from the U.S. Centers for Disease Control and Prevention (CDC), the company is prepared to deliver the vaccine promptly. Additionally, Novavax is collaborating with global regulatory authorities to secure authorizations or approvals for its JN.1 COVID-19 vaccine.

The NVX-CoV2705 is an updated formulation of Novavax's prototype COVID-19 vaccine, NVX-CoV2373, specifically designed to target the JN.1 variant. This protein-based vaccine uses copies of the SARS-CoV-2 surface spike protein to prime the immune system. Novavax's proprietary Matrix-M adjuvant enhances and broadens this immune response. The vaccine is a ready-to-use liquid formulation, stored at temperatures between 2° to 8°C, leveraging existing vaccine supply and cold chain infrastructure.

The Matrix-M adjuvant, a saponin-based technology, significantly enhances the immune response by stimulating antigen-presenting cells at the injection site and improving antigen presentation in local lymph nodes. This adjuvant technology is integral to the vaccine's efficacy and durability.

Novavax, headquartered in Gaithersburg, Maryland, focuses on discovering, developing, and commercializing innovative vaccines to combat serious infectious diseases. The company's vaccine platform combines a recombinant protein approach with advanced nanoparticle technology and the Matrix-M adjuvant. Novavax’s portfolio includes its COVID-19 vaccine, with ongoing development for a combined COVID-19 and influenza vaccine. Moreover, its adjuvant is utilized in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine.

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