Valneva SE reported strong immune responses after a third yearly booster dose of Lyme disease vaccine candidate, VLA15. The anamnestic antibody response was significant across all six serotypes, with no safety concerns observed in any age group. The vaccine has advanced to Phase 3 trials with approximately 476,000 cases of Lyme disease diagnosed annually in the U.S. and 132,000 in Europe. Pfizer aims to submit a Biologics License Application (BLA) to the FDA and Marketing Authorization Application (MAA) to the EMA in 2026. The vaccine has shown high seroconversion rates and favorable safety profiles, moving closer to availability for adults and children in Lyme-endemic areas. A strong immune response was observed in children and adults after receiving the third yearly booster dose, with a significant antibody response across all six serotypes. No safety concerns were reported by the independent Data Monitoring Committee, aligning with previous booster results. The medical need for a Lyme disease vaccine is increasing as the disease spreads geographically. Valneva SE, a specialty vaccine company, is developing prophylactic vaccines for infectious diseases, including a Lyme disease vaccine candidate in advanced clinical development in partnership with Pfizer. Vaccine revenues support ongoing research and development efforts. A study found a strong immune response in children and adults after receiving a third yearly booster dose. The response included significant anamnestic antibody response across all six serotypes. The independent Data Monitoring Committee reported no safety concerns in any age group, consistent with previous booster results.

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