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

The European Medicines Agency (EMA) has officially begun its assessment of Pfizer and Valneva's 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate, PF-07307405, after validating the Marketing Authorization Application (MAA). Phase 3 clinical trials demonstrated an efficacy rate of over 70% in individuals aged five years and older. This marks a significant step towards a potential first approved vaccine for Lyme disease, a prevalent tick-borne illness in Europe.