EMA Validates Marketing Application for Lyme Disease Vaccine by Pfizer and Valneva

The European Medicines Agency (EMA) has endorsed the Marketing Authorization Application for a Lyme disease vaccine candidate developed by Pfizer and Valneva. The validation marks a significant step for PF-07307405, their 6-valent OspA-based vaccine, which showed over 70% efficacy in the Phase 3 VALOR trial involving individuals aged five and older. The vaccine demonstrated a favorable safety profile, with no significant concerns reported.

Lyme disease is the most prevalent vector-borne illness in Europe, impacting over 100,000 yearly. The vaccine targets the Borrelia burgdorferi bacterium. The application for regulatory assessment is a collaborative effort by Pfizer and Valneva, promoting a new protective measure against Lyme Disease.