---
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"
generated_at: "2026-06-01T05:47:01.952969+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Novavax FDA sets PDUFA date April 2025 for COVID vaccine BLA; plans EUA sales for 2024-2025

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-068875
- JSON: https://secwatch.observer/filing/0001104659-24-068875.json
- Plain text: https://secwatch.observer/filing/0001104659-24-068875.txt

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