Rajan Sharma

Maurice Raycroft

Oscar Haffen Lamm

Samir Devani

Simon Scholes

Suzanne van Voorthuizen

Vamil Divan

Damien Choplain

Maury Raycroft

Sebastian Vandishot

- Valneva SE announced **positive Phase 2 safety and immunogenicity data** for its Lyme disease vaccine candidate, **VLA15**, showing a **strong immune response** and **no safety concerns** after a third yearly booster dose in children and adults.  **[1836564_0001836564-25-000014_valnevapr09-03x2025.htm:0]** 
- VLA15 is the **most clinically advanced** Lyme disease vaccine candidate, with **two Phase 3 trials nearing completion**.  **[1836564_0001836564-25-000014_valnevapr09-03x2025.htm:0]** **[1836564_0001836564-25-000014_valnevapr09-03x2025.htm:1]** 
- Subject to positive data, Valneva's partner, Pfizer, aims to submit regulatory applications (BLA to U.S. FDA and MAA to European EMA) in **2026**.  **[1836564_0001836564-25-000014_valnevapr09-03x2025.htm:0]** 
- There are **currently no approved human vaccines for Lyme disease**, which affects an estimated **476,000 people in the U.S.** and **132,000 cases in Europe annually**.  **[1836564_0001836564-25-000014_valnevapr09-03x2025.htm:0]** **[1836564_0001836564-25-000014_valnevapr09-03x2025.htm:2]**

Valneva Reports Positive Phase 2 Results for Lyme Disease Vaccine Candidate

- The **FDA has suspended the license for Valneva's Chikungunya vaccine, IXCHIQ®**, in the U.S., effective immediately, requiring the company to **stop shipping and selling the vaccine** in the country.  **[1836564_0001836564-25-000011_valnevapr8-25x2025.htm:0]** 
- The suspension is based on **four new reports of serious adverse events (SAEs)** consistent with chikungunya-like illness, which occurred outside the United States.  **[1836564_0001836564-25-000011_valnevapr8-25x2025.htm:0]** 
- Valneva is **evaluating the potential financial impact** of a permanent withdrawal of the IXCHIQ® license in the U.S. but is **not modifying its revenue guidance** at this time.  **[1836564_0001836564-25-000011_valnevapr8-25x2025.htm:0]** 
- In the first half of 2025, IXCHIQ® sales contributed **€7.5 million** to Valneva's **€91 million total product sales**.  **[1836564_0001836564-25-000011_valnevapr8-25x2025.htm:0]**

Valneva announces FDA suspension of Chikungunya vaccine license in US

- The **U.S. Food and Drug Administration (FDA)** has **suspended** Valneva's chikungunya vaccine, **IXCHIQ**, license in the United States, requiring a halt to all shipping and sales.  **[1836564_10ba305178da43c780091165b7412f63]** 
- This suspension follows reports of **four new serious adverse events** consistent with chikungunya-like illness, including cases among elderly individuals and one hospitalization.  **[1836564_10ba305178da43c780091165b7412f63]** 
- In the **first half of 2025**, sales of IXCHIQ contributed **7.5 million euros** to Valneva's total product sales of **91 million euros**.  **[1836564_10ba305178da43c780091165b7412f63]** 
- Valneva is investigating the cases and assessing the potential financial impact of a permanent withdrawal but has **not changed its revenue guidance**.  **[1836564_10ba305178da43c780091165b7412f63]**

Valneva Chikungunya Vaccine License Suspended in U.S.

Valneva (VALN)