EMA Validates Marketing Authorization Application for Pfizer and Valneva's Lyme Disease Vaccine Candidate

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate developed by Pfizer and Valneva. This validation formally initiates the centralized review procedure for the vaccine, which is based on promising efficacy data from the Phase 3 VALOR clinical trial. The trial showed over 70% efficacy in preventing Lyme disease in individuals aged five years and older, with the vaccine being well-tolerated and no safety concerns identified.