{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-068875","form_type":"8-K","ticker":"NVAX","cik":"0001000694","company_name":"NOVAVAX INC","filed_at":"2024-06-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:16.784221+00:00","generated_at":"2026-06-01T05:47:01.952969+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Novavax FDA sets PDUFA date April 2025 for COVID vaccine BLA; plans EUA sales for 2024-2025","bullets":["FDA completed BLA filing review; PDUFA goal date set for April 2025 for COVID-19 vaccine.","Company to sell COVID-19 vaccine under EUA for 2024-2025 season in U.S.","Plans to initiate pivotal Phase 3 trial for COVID-Influenza Combination (CIC) in H2 2024.","Targeting updated single-dose vial COVID vaccine for 2024-2025 season; possible combo vaccine launch in 2026.","Continuing global restructuring and cost reduction plan to manage cash flow."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-068875","json":"https://secwatch.observer/filing/0001104659-24-068875.json","markdown":"https://secwatch.observer/filing/0001104659-24-068875.md","text":"https://secwatch.observer/filing/0001104659-24-068875.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1000694/000110465924068875/0001104659-24-068875-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1000694/000110465924068875/tm2416490d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T05:47:01.952969+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"}