Pfizer and Valneva announced the European Medicines Agency (EMA) validated their Marketing Authorization Application for VLA15, an investigational Lyme disease vaccine. The validation confirms the application is complete. It begins the formal review process for potential approval in the European Union.
The submission represents a significant step for the first potential human vaccine for Lyme disease. Lyme disease is the most common vector-borne illness in the Northern Hemisphere. Positive data from the Phase 3 VALOR clinical trial in individuals aged five and older supports the application. If approved, Pfizer will commercialize the vaccine.