---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-031099"
form_type: "8-K"
ticker: "NVAX"
cik: "0001000694"
company_name: "NOVAVAX INC"
filed_at: "2025-04-02T23:59:59+00:00"
generated_at: "2026-05-23T23:05:02.258089+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Novavax says FDA missed PDUFA deadline for COVID-19 vaccine BLA; still awaiting decision

## Summary
- FDA's April 1 PDUFA date passed; no official decision received as of April 2, 2025.
- Novavax completed all FDA information requests and believes BLA is ready for approval.
- Phase 3 data cited showing vaccine is safe and effective for COVID-19 prevention.
- Company positions its vaccine as an attractive alternative to mRNA COVID-19 vaccines in U.S.

## SEC filing metadata
- accession: 0001104659-25-031099
- form_type: 8-K
- ticker: NVAX
- cik: 0001000694
- company_name: NOVAVAX INC
- filed_at: 2025-04-02T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1000694/000110465925031099/0001104659-25-031099-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1000694/000110465925031099/tm2511339d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-031099
- JSON: https://secwatch.observer/filing/0001104659-25-031099.json
- Plain text: https://secwatch.observer/filing/0001104659-25-031099.txt

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