Novavax 2024-2025 Formula COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

Core Points - Novavax's COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has received Emergency Use Authorization (EUA) from the FDA for individuals aged 12 and older [1][4] - The vaccine is the only protein-based option available in the U.S. for preventing COVID-19 in the specified age group [1] - Pre-filled syringes of the vaccine will be available in thousands of locations across the U.S., including pharmacies and regional grocers [2][3] Vaccine Details - The updated vaccine targets the JN.1 variant, which is the parent strain of currently circulating variants, and has shown robust cross-reactivity against various JN.1 lineage viruses [3][10] - The EUA was based on non-clinical data demonstrating protection and cross-reactivity against JN.1 and its lineage viruses [3] - The vaccine is formulated using Novavax's Matrix-M™ adjuvant, which enhances the immune response [10][11] Regulatory and Safety Information - The vaccine has not been fully approved or licensed by the FDA but is authorized for emergency use [4] - The EUA will remain effective for the duration of the COVID-19 EUA declaration unless revoked sooner [5] - Contraindications include a known history of severe allergic reactions to any component of the vaccine [7] Adverse Reactions - Common adverse reactions reported in clinical trials include headache, nausea, muscle pain, joint pain, and fatigue [3][9] - Management protocols for potential allergic reactions and other adverse events are in place [8]