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) from Pfizer and Valneva for their 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate, PF-07307405. This validation marks the beginning of the EMA's formal assessment of the application. The submission is supported by efficacy and safety data from the Phase III VALOR clinical trial, which demonstrated over 70% efficacy in preventing Lyme disease in participants aged five years and older. If approved, this vaccine would be the first of its kind for human use.