Valneva SE reported that the Phase 2 study VLA15‑221 of its Lyme disease vaccine candidate VLA15 produced positive final immunogenicity and safety data, including a robust anamnestic response six months after a third booster dose. The data confirm that antibody levels remained well above baseline across all six Lyme disease serotypes and all age groups, supporting the yearly vaccination strategy planned for the Phase 3 VALOR trial.
The safety profile was unchanged from earlier interim analyses, with no serious adverse events attributed to the vaccine and no concerns raised by the independent Data Monitoring Committee. The sustained antibody response after the third dose suggests that a single annual booster could provide durable protection, a key advantage for a disease that is expanding geographically and affecting an estimated 476,000 Americans and 132,000 Europeans each year.
Valneva’s financial performance in the first nine months of 2025 shows a mixed picture: total revenues rose 8.9% to €127.0 million, while the company posted a net loss of €65.2 million, compared with a €24.7 million profit in the same period of 2024. The revenue growth reflects stronger demand in core vaccine segments, but the loss is driven by increased R&D spend and one‑time restructuring charges associated with scaling the VLA15 program.
The positive Phase 2 results reinforce Valneva’s partnership with Pfizer, which is leading late‑stage development and commercialization. Subject to positive Phase 3 data, Pfizer plans to submit regulatory applications in 2026, positioning VLA15 as the first Lyme disease vaccine in the market. The market for Lyme disease treatment is projected to reach $1.6 billion by 2031, and a vaccine could capture a significant share of this growing opportunity.
Chief Medical Officer Dr. Juan Carlos Jaramillo said the final Phase 2 data confirm the potential benefits of booster doses across all age groups and bring the company closer to making the vaccine available. Market reaction was positive, with analysts noting the strong immunogenicity and safety profile as key drivers of investor confidence in Valneva’s pipeline.
Overall, the announcement marks a critical step toward regulatory approval and commercial launch, potentially transforming the Lyme disease prevention landscape and providing a new revenue stream for Valneva and its partner Pfizer.
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