---
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"
generated_at: "2026-05-30T01:28:42.964524+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Novavax's COVID-flu combo and standalone flu vaccines

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-116593
- JSON: https://secwatch.observer/filing/0001104659-24-116593.json
- Plain text: https://secwatch.observer/filing/0001104659-24-116593.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.