Novavax Submits Application to EMA for Updated 2024-2025 COVID-19 Vaccine

Novavax, Inc., a prominent player in the field of protein-based vaccines, has announced a significant regulatory filing with the European Medicines Agency (EMA). The company has sought a type II variation for the Marketing Authorization of its JN.1 COVID-19 vaccine (NVX-CoV2705) to include individuals aged 12 and above. This move aligns with guidelines from both the EMA and the World Health Organization (WHO) to target the JN.1 lineage in the upcoming fall vaccination season.

John C. Jacobs, President and CEO of Novavax, emphasized the company's commitment to providing a protein-based alternative to mRNA vaccines in European markets this fall. He stated that their updated COVID-19 vaccine is effective against currently circulating strains, including KP.2 and KP.3.

Nonclinical studies have shown that the JN.1 vaccine can induce broad neutralization responses to JN.1 lineage viruses, including those with F456L and R346T mutations, as well as "FLiRT" and "FLuQE" variants. The vaccine also elicits polyfunctional, Th1-biased CD4+ T cell responses to a variety of JN.1 lineage variants. The JN.1 COVID-19 vaccine specifically targets the "parent strain" of both KP.2 and KP.3.

Novavax plans to make its vaccine available in unit-dose vials for immediate distribution in the European Union, contingent upon approval. The company has also submitted applications to the U.S. Food and Drug Administration (FDA) and is in communication with other regulatory authorities worldwide for the authorization or approval of the JN.1 COVID-19 vaccine.

The NVX-CoV2705 vaccine represents an updated version of Novavax's earlier COVID-19 vaccine prototype (NVX-CoV2373), designed to target the JN.1 variant. This protein-based vaccine is developed by replicating the surface spike protein of the SARS-CoV-2 virus, which causes COVID-19. Novavax employs its unique recombinant nanoparticle technology to create a non-infectious spike protein that acts as an antigen, priming the immune system to recognize the virus. The immune response is further enhanced by Novavax's Matrix-M adjuvant. The vaccine is available as a ready-to-use liquid formulation and can be stored at temperatures ranging from 2° to 8°C, facilitating its distribution through existing vaccine supply chains.

Novavax's Matrix-M adjuvant plays a crucial role in amplifying the immune response. This patented saponin-based adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes, resulting in a broader and more durable immune response.

Novavax, Inc. is dedicated to improving global health through the discovery, development, and commercialization of innovative vaccines designed to protect against serious infectious diseases. Based in Gaithersburg, Maryland, the company's differentiated vaccine platform combines a recombinant protein approach with innovative nanoparticle technology and the Matrix-M adjuvant to boost the immune response. Novavax's portfolio includes its COVID-19 vaccine and a pipeline that features a combined COVID-19 and influenza vaccine. Additionally, the company's adjuvant is used in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine.

As Novavax continues to advance its vaccine technology, it remains focused on addressing the evolving challenges posed by infectious diseases, thereby contributing to global public health initiatives.