US FDA grants fast track designation to Sanofi’s mRNA vaccine candidate for prevention of chlamydia infection

The US Food and Drug Administration (FDA) has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the potential of the vaccine candidate to address a serious condition and address an unmet public health need.

The chlamydia vaccine candidate has been designed to protect against primary genital tract infection and reinfection by the bacterium Chlamydia trachomatis. Following a promising pre-clinical programme, Sanofi is planning a phase 1/2 randomized, clinical study designed to evaluate the immunogenicity and safety of the chlamydia vaccine candidate in adults aged 18 to 29 years. The study is due to start in coming days.

Jean-François Toussaint, global head of vaccines R&D, said: “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.”

Chlamydia, caused by the bacterium Chlamydia trachomatis, is a common bacterial infection of the reproductive tract with consequences for developing infertility and pregnancy complications. In 2020, there were 129 million worldwide cases of chlamydia among adults (15-49 years old), 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, meaning there is a significant risk that infections go unrecognized, leading to untreated cases and unintentional transmission. Programmes that have been put in place to prevent infection rates from rising have proven insufficient, highlighting the urgent public health need for a vaccine.

The development of this vaccine candidate is part of the Translational Science Hub, a partnership with the Queensland Government, Griffith University, and the University of Queensland, connecting world-class researchers in Queensland, Australia, with Sanofi scientists in France and the US.

Sanofi is an innovative global healthcare company, driven by one purpose: the company chase the miracles of science to improve people’s lives.

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