FDA Grants Fast Track Designation to Sanofi's Chlamydia Vaccine Candidate

The U.S. Food and Drug Administration (FDA) has granted fast track designation to Sanofi's mRNA vaccine candidate aimed at preventing chlamydia infections, a significant step in addressing a pressing public health need. The vaccine targets both primary genital tract infections and reinfections caused by Chlamydia trachomatis, the leading bacterial sexually transmitted infection worldwide. Following a promising preclinical program, Sanofi plans to initiate a Phase 1/2 randomized clinical trial to evaluate the vaccine's immunogenicity and safety in adults aged 18 to 29. This initiative is part of a collaboration with the Queensland government and several Australian universities. The company emphasizes that existing antibiotic treatments have not effectively controlled rising infection rates, underscoring the necessity for a preventive vaccine. Jean-François Toussaint, Global Head of Vaccines R&D, highlighted the importance of this vaccine, stating that millions are currently living with undiagnosed chlamydia, which can lead to severe long-term health issues if untreated.