Pfizer and Valneva Report Partial Discontinuation of Patient Evaluation in P-III Clinical Trial for VLA15 to Treat Lyme Disease
- Pfizer has discontinued the evaluation of 50% of the patients with Lyme disease enrolled in the P-III clinical trial (VALOR) that analyses the safety, efficacy & immunogenicity of VLA15
- The discontinuation was marked following the violations of GCP at certain clinical trial sites run by a third-party trial site operator. The clinical trials remain ongoing as Pfizer continues to enroll new patients at those sites
- VLA15 is a Lyme disease vaccine candidate that blocks the outer surface protein A (OspA) of the bacteria causing Lyme disease, Borrelia burgdorferi, thereby inhibiting its ability to leave the tick & infect humans. Pfizer expects to submit a BLA to the US FDA & an MAA to the EMA for VLA15 by 2025
Ref: Globenewswire | Image: Valneva
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