VALN - Valneva says late-stage lot-to-lot trial for chikungunya vaccine met main goal

Announcing topline results from its lot-to-lot trial for single-shot chikungunya vaccine candidate, VLA1553, Valneva (NASDAQ:VALN) said that the Phase 3 study met its primary endpoint. Results suggest that the three consecutively manufactured vaccine lots generated equivalent immune responses in terms of neutralizing antibody levels at Day 29 following the vaccination. Lot-to-lot consistency demonstrated in a trial is one of the criteria required for vaccine approval. In the 408-subject study involving those aged 18 to 45 years, all three lots indicated an immunogenicity and safety profile consistent with the pivotal Phase 3 study, the French biotech added. The lot-to-lot trial is advancing until the final six-month analysis, and the final results are expected in Q2 2022. “The lot-to-lot data will be part of our submission with the US Food and Drug Administration (FDA), which we plan to start in 2022,” Valneva (VALN) Chief Medical Officer Juan Carlos Jaramillo remarked. Read more about

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Valneva says late-stage lot-to-lot trial for chikungunya vaccine met main goal