FDA approves Novavax's Nuvaxovid 2025-2026 COVID-19 vaccine for high-risk populations

NOVAVAX INC

Approved for adults 65+ and high-risk individuals 12-64; only protein-based non-mRNA COVID-19 vaccine available in U.S. for 2025-2026 season.
Shelf life extended from 3 to 6 months for the 2025-2026 formula.
FDA requires two postmarketing studies: a Phase 3 safety/immunogenicity study and a Phase 4 placebo-controlled trial on post-COVID vaccination syndrome.
Sanofi to lead commercialization; Novavax receives tiered royalties on sales.
Clinical data show JN.1 strain induces immunity against multiple JN.1 lineage variants including NB.1.8.1 and XEC.

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