FDA grants fast track designation to chlamydia vaccine candidate
Ella Day | March 28, 2025 | News story | Research and Development | FDA, Infections and infestations, Sanofi, chlamydia, vaccination
The US Food and Drug Association (FDA) has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection.
The chlamydia vaccine candidate has been designed to protect against primary genital tract infection and reinfection caused by the bacterium Chlamydia trachomatis.
Sanofi is an international pharma and healthcare company, providing vaccination and treatment services. It is planning a phase 1/2 clinical study aiming to evaluate the immunogenicity and safety of the chlamydia vaccine candidate. Due to start in the next few days, it will be a randomised study and will take place in adults aged 18 to 29 years.
Infection can contribute to pelvic inflammatory diseases in women, with consequences for developing infertility and pregnancy complications. There were 129 million worldwide cases of chlamydia among adults (15 to 49 years old) in 2020, with the highest rates of infection among adolescents and young adults.
Although chlamydia can be treated with antibiotics when diagnosed, over 80% of chlamydia cases are asymptomatic, posing significant risk of unrecognised infections, leading to untreated cases and unintentional transmission.
Sanofi’s global head of vaccines research and development, Jean-François Toussaint, commented: “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 programme we aim to make chlamydia a preventable disease through vaccination.”
Ella Day
28/3/25
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