Pfizer and Valneva said the European Medicines Agency has validated the Marketing Authorization Application (MAA) for PF-07307405, their investigational Lyme disease vaccine candidate, allowing the regulator to begin reviewing the filing. The submission is backed by Phase 3 VALOR data showing efficacy of more than 70% in preventing Lyme disease in people aged five years and older, while the vaccine was well tolerated and no safety concerns were identified. The companies said the candidate could become the first approved human Lyme disease vaccine, a notable step for Europe where Lyme disease affects more than 100,000 people each year and where more than 200 million people live in risk areas. PF-07307405 is a 6-valent OspA-based vaccine candidate that targets six Borrelia serotypes and is designed to block transmission from infected ticks during feeding.