{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-116593","form_type":"8-K","ticker":"NVAX","cik":"0001000694","company_name":"NOVAVAX INC","filed_at":"2024-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:07.287688+00:00","generated_at":"2026-05-30T01:28:42.964524+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA lifts clinical hold on Novavax's COVID-flu combo and standalone flu vaccines","bullets":["FDA removed clinical hold on Novavax's IND for CIC and stand-alone influenza candidates on Nov 11.","Hold was placed Oct 16 due to a serious adverse event (motor neuropathy, later ALS) in a Phase 2 participant.","Novavax provided additional data confirming the event was not related to the vaccine.","FDA cleared Novavax to begin enrollment in the planned Phase 3 trial for both vaccine candidates.","Novavax will work with investigators to resume trial activities as quickly as possible."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-116593","json":"https://secwatch.observer/filing/0001104659-24-116593.json","markdown":"https://secwatch.observer/filing/0001104659-24-116593.md","text":"https://secwatch.observer/filing/0001104659-24-116593.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1000694/000110465924116593/0001104659-24-116593-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1000694/000110465924116593/tm2428029d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T01:28:42.964524+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"}