---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-050226"
form_type: "8-K"
ticker: "NVAX"
cik: "0001000694"
company_name: "NOVAVAX INC"
filed_at: "2025-05-19T23:59:59+00:00"
generated_at: "2026-05-21T00:56:56.113661+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Novavax receives FDA approval for Nuvaxovid COVID-19 vaccine; triggers $175M Sanofi milestone

## Summary
- FDA approves BLA for Nuvaxovid for COVID-19 in adults 65+ and high-risk individuals 12-64.
- Approval triggers $175M milestone payment from Sanofi under May 2024 Collaboration and License Agreement.
- FDA requests new Phase 4 postmarketing efficacy trial in 50-64 age group without high-risk conditions; Novavax working with Sanofi on funding.
- Novavax reiterates FY2025 R&D+SG&A guidance of $475-525M; projects ~$350M for FY2026 and ~$250M for FY2027.
- Expects commercial delivery of 2025-2026 COVID-19 vaccine formula in US this Fall with Sanofi, pending VRBPAC recommendation May 22.

## SEC filing metadata
- accession: 0001104659-25-050226
- form_type: 8-K
- ticker: NVAX
- cik: 0001000694
- company_name: NOVAVAX INC
- filed_at: 2025-05-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1000694/000110465925050226/0001104659-25-050226-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1000694/000110465925050226/tm2515521d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-050226
- JSON: https://secwatch.observer/filing/0001104659-25-050226.json
- Plain text: https://secwatch.observer/filing/0001104659-25-050226.txt

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