{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-108950","form_type":"8-K","ticker":"NVAX","cik":"0001000694","company_name":"NOVAVAX INC","filed_at":"2024-10-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:07.286534+00:00","generated_at":"2026-05-30T13:32:22.560627+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA places clinical hold on Novavax's combo COVID-flu and standalone flu vaccines after motor neuropathy SAE","bullets":["FDA placed clinical hold on Novavax's IND for CIC and standalone influenza vaccine candidates.","Hold triggered by spontaneous report of serious adverse event: motor neuropathy in a single Phase 2 participant.","Participant received vaccine Jan 2023; trial completed Jul 2023; SAE reported Sep 2024.","Clinical hold may delay initiation of Phase 3 immunogenicity trial for CIC and influenza vaccine.","COVID-19 IND for Novavax's COVID-19 vaccine is not impacted by the clinical hold."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-108950","json":"https://secwatch.observer/filing/0001104659-24-108950.json","markdown":"https://secwatch.observer/filing/0001104659-24-108950.md","text":"https://secwatch.observer/filing/0001104659-24-108950.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1000694/000110465924108950/0001104659-24-108950-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1000694/000110465924108950/tm2426249d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T13:32:22.560627+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"}