EMA validates Pfizer-Valneva Lyme vaccine application

The European Union — European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, a 6-valent OspA-based Lyme disease vaccine candidate co-developed by Pfizer and Valneva SE. The validation allows the EMA to begin its formal assessment of the application. The submission is supported by efficacy and safety data from the Phase 3 VALOR clinical trial, which enrolled 9,437 participants aged five years and older across the U.S., Canada, and Europe. The trial demonstrated efficacy of more than 70% in preventing Lyme disease, with no safety concerns identified. Currently, no approved human vaccines exist for Lyme disease. PF-07307405 targets the outer surface protein A of Borrelia burgdorferi and covers six OspA serotypes prevalent in North America and Europe. Pfizer and Valneva entered into a collaboration and license agreement in April 2020, with Pfizer holding exclusive manufacturing and commercialization rights upon regulatory approval. The EMA validation marks a significant milestone toward potentially bringing the first Lyme disease vaccine to Europe, where the disease affects more than 100,000 people annually.