Sanofi Secures FDA Fast Track Designation for its Chlamydia Prevention mRNA Vaccine

The U.S. Food and Drug Administration (FDA) has granted fast track designation to Sanofi’s mRNA vaccine candidate for chlamydia prevention. The designation recognizes the vaccine’s potential to address a significant public health need. The vaccine candidate aims to protect against initial and recurrent genital tract infections caused by Chlamydia trachomatis, the leading cause of bacterial sexually transmitted infections worldwide.

Phase 1/2 Trial to Assess Safety and Immunogenicity of Chlamydia Vaccine

The fast track pathway accelerates the development and review of drugs for medical conditions with unmet needs. It provides pharmaceutical companies with benefits such as more frequent FDA meetings and expedited review processes. After a successful preclinical program, Sanofi plans to initiate a Phase 1/2 randomized clinical trial to assess the immunogenicity and safety of its chlamydia vaccine candidate in adults aged 18 to 29. The study is set to begin in the coming days.

Sanofi is developing the vaccine in collaboration with the Queensland government, Griffith University, and the University of Queensland in Australia. The company has described the preclinical program as “promising”.

Jean-François Toussaint, Global Head of Vaccines R&D, stated, “Millions of people currently live with undiagnosed chlamydia, including asymptomatic infection that can also cause severe long-term health effects if left untreated. Antibiotics to treat chlamydia have not been successful in controlling rising infection rates. With our program we aim to make chlamydia a preventable disease through vaccination.”

Global Chlamydia Infections Estimated at 128.5 Million in 2020

Chlamydia, a sexually transmitted infection caused by the bacterium Chlamydia trachomatis, affects both men and women and can be effectively treated with antibiotics. Early treatment prevents long-term complications, but if left untreated, chlamydia can lead to serious health issues, including pelvic inflammatory disease, infertility, and ectopic pregnancy. It can also increase the risk of acquiring or transmitting HIV and other sexually transmitted infections.

In 2020, an estimated 128.5 million new cases of Chlamydia trachomatis infection occurred globally among adults aged 15 to 49. The prevalence was estimated at 4.0% in women and 2.5% in men within this age group.

The U.S. FDA, the United Kingdom, and the European Medicines Agency (EMA) have not approved any vaccines for preventing chlamydia infections. Currently, chlamydia infections are treated with antibiotics such as azithromycin or doxycycline, which effectively clear the infection. However, reinfection is common, and untreated cases can lead to serious complications, including infertility and pelvic inflammatory disease. Sanofi’s investigational mRNA vaccine aims to provide protection against both initial and recurrent Chlamydia trachomatis infections, potentially reducing the global burden of the disease and its associated health risks.

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Denisse Sandoval