EMA Validates Pfizer and Valneva's Lyme Disease Vaccine Application

What happened

The European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for PF-07307405, a 6-valent OspA-based Lyme disease vaccine candidate developed by Pfizer and Valneva. The application is based on Phase 3 VALOR trial results showing efficacy of more than 70% and good tolerability in participants aged five years and older.

Why it matters

This is the first vaccine of its kind for Europe. Lyme disease is the most common vector-borne illness in Europe, affecting over 100,000 people annually. The vaccine aims to provide protection against serious complications affecting the skin, joints, nervous system, and heart.