---
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"
generated_at: "2026-05-30T13:32:22.560627+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA places clinical hold on Novavax's combo COVID-flu and standalone flu vaccines after motor neuropathy SAE

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-108950
- JSON: https://secwatch.observer/filing/0001104659-24-108950.json
- Plain text: https://secwatch.observer/filing/0001104659-24-108950.txt

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