# Valneva

Type: Company (VALN)

Source: Biotech Intelligence Brief — https://getbiobrief.com/entity/valneva
Canonical HTML page: https://getbiobrief.com/entity/valneva

## Timeline

- **2027**: Potential Launch — Anticipated commercial availability following regulatory approval and CDC recommendation.
- **2026-Q4**: Regulatory Filing — Expected submission of Biologics License Application (BLA) to the FDA.
- **2026-04**: Pfizer-Valneva regulatory submission planned — Pfizer and Valneva announce they intend to file for approval of their Lyme disease vaccine candidate this spring, according to KFF Health News.
- **2026-03-25**: Efficacy Results — Trial data shows over 70% efficacy against Lyme disease in endemic regions.
- **2022-08-01**: Phase 3 Initiation — Pfizer and Valneva launch the VALOR Phase 3 clinical trial for VLA15.
- **2002-02**: LYMErix withdrawn from market — Citing low demand, lawsuits alleging side effects, and mounting public mistrust, the manufacturer pulls the vaccine only three years after launch.
- **1998-12**: FDA approves LYMErix — SmithKline Beecham (now GSK) receives approval for the first Lyme disease vaccine, aimed at preventing the tick-borne illness.

## Recent coverage (3 stories)

### Pfizer-Valneva Lyme Vaccine Targets 476K Annual Cases, But Uptake Uncertain
2026-08-07 07:55:48 · Sentiment: Neutral · Impact: 5/10 · Sources: 2

Pfizer and Valneva’s planned regulatory submission for a new Lyme disease vaccine enters a market haunted by the failure of LYMErix and amplified vaccine skepticism, challenging the blockbuster potential of a shot aimed at 476,000 annual U.S. cases.
Full story: https://getbiobrief.com/story/pfizer-valneva-lyme-vaccine-bio-2026

### Pfizer's Lyme Vaccine Shows Over 70% Efficacy in Pivotal Phase 3 Trial
2026-03-25 02:03:00 · Sentiment: Positive · Impact: 7/10 · Sources: 2

Pfizer and Valneva have reported positive Phase 3 results for their Lyme disease vaccine candidate, VLA15, demonstrating an efficacy rate exceeding 70%. This development marks a significant milestone in addressing the growing public health threat of tick-borne illnesses, potentially offering the first preventative vaccine for the disease in over two decades.
Full story: https://getbiobrief.com/story/pfizer-lyme-disease-vaccine-phase-3-results

### Chikungunya Transmission Risk Expands Across Europe Amid Climate Shift
2026-02-19 12:54:45 · Sentiment: Negative · Impact: 7/10 · Sources: 2

A landmark study reveals that the excruciating tropical disease Chikungunya is now capable of local transmission across most of Europe. Driven by the northward migration of the Aedes albopictus mosquito, this shift creates an urgent demand for vaccines and diagnostic infrastructure in previously unaffected regions.
Full story: https://getbiobrief.com/story/chikungunya-transmission-risk-europe-pharma-impact

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This page is a machine-readable summary. Sentiment measures the directional read of each development for this entity, not the tone of the reporting; impact weights consequence, not syndication reach. See https://getbiobrief.com/guides/methodology for the full editorial methodology.