Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) on Wednesday reported positive final Phase 2 immunogenicity and safety results for its Lyme disease vaccine candidate, VLA15.

The study showed strong anamnestic immune responses and antibody levels remaining well above baseline six months after a third yearly booster across all age groups and serotypes.

No safety concerns were identified by the independent Data Monitoring Committee in any age group, confirming a favourable safety profile.

Results support the three-dose primary vaccination schedule with a yearly booster prior to each Lyme season, consistent with the Phase 3 VALOR trial protocol.

Pfizer (NYSE:PFE) and Valneva are collaborating on VLA15's development and commercialisation, with Pfizer planning to submit a Biologics License Application to the FDA and a Marketing Authorisation Application to the EMA in 2026, subject to positive Phase 3 data.

VLA15 remains the most advanced human Lyme disease vaccine candidate, addressing an unmet need in the United States and Europe, where hundreds of thousands of cases are reported annually.