European Medicines Agency Validates Marketing Application for Pfizer-Valneva Lyme Disease Vaccine Candidate

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, Pfizer and Valneva's 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate. This validation initiates the formal assessment process for the vaccine, which demonstrated over 70% efficacy in the Phase 3 VALOR clinical trial and was well tolerated with no identified safety concerns.