Novavax COVID-19 Vaccine Targeting JN.1 Authorized for Emergency Use in the U.S.
Key Insights
The FDA has granted Emergency Use Authorization (EUA) for Novavax's updated COVID-19 (search) vaccine (NVX-CoV2705) for individuals aged 12 and older.
The updated vaccine targets the JN.1 variant and demonstrates cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3 and LB.1.
The CDC has recommended the use of 2024-2025 COVID-19 (search) vaccines, including Novavax's, for individuals six months and older, regardless of specific viral strains.
Novavax has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its updated COVID-19 (search) vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705), for active immunization to prevent COVID-19 in individuals aged 12 and older. This authorization allows for the immediate distribution and administration of the vaccine across the United States.
The Novavax COVID-19 (search) Vaccine, Adjuvanted (2024-2025 Formula) is included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024.
Targeting JN.1 Variant
The updated Novavax vaccine is designed to target the JN.1 variant, which is a parent strain of currently circulating variants. Non-clinical data submitted to the FDA demonstrated that the vaccine exhibits robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1. This broad cross-reactivity is expected to provide protection against a range of emerging SARS-CoV-2 (search) variants.
John C. Jacobs, President and Chief Executive Officer of Novavax, stated, "Our updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1."
Availability and Distribution
Following the Center for Biologics Evaluation and Research release of vaccine batches, pre-filled syringes of the vaccine will be available in thousands of locations, including retail and independent pharmacies and regional grocers, ensuring widespread access for consumers across the country.
Clinical Considerations
The EUA is based on non-clinical data demonstrating the vaccine's cross-reactivity against the JN.1 variant and its related lineages. Clinical trials of Novavax's prototype COVID-19 (search) vaccine (NVX-CoV2373) have identified common adverse reactions, including headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.
Important Safety Information
The Novavax COVID-19 (search) Vaccine, Adjuvanted (2024-2025 Formula) is contraindicated for individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any of its components. Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration. Clinical trial data indicates increased risks of myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted. Syncope (fainting) may occur in association with administration of injectable vaccines. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted. The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
About NVX-CoV2705
NVX-CoV2705 is an updated version of Novavax's prototype COVID-19 (search) 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 (search) 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.