{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-084049","form_type":"8-K","ticker":"NVAX","cik":"0001000694","company_name":"NOVAVAX INC","filed_at":"2025-08-27T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.099928+00:00","generated_at":"2026-05-17T09:36:14.092405+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA approves Novavax's Nuvaxovid 2025-2026 COVID-19 vaccine for high-risk populations","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-084049","json":"https://secwatch.observer/filing/0001104659-25-084049.json","markdown":"https://secwatch.observer/filing/0001104659-25-084049.md","text":"https://secwatch.observer/filing/0001104659-25-084049.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1000694/000110465925084049/0001104659-25-084049-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1000694/000110465925084049/tm2524511d2_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T09:36:14.092405+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}