Approvals

US regulators have granted a fast track designation to Sanofi’s mRNA chlamydia vaccine, putting it in line for development benefits and an expedited review.

The pharma company will next run a phase 1/2 clinical study to evaluate the immunogenicity and safety of the vaccine candidate in adults aged 18 to 29 years.

Sanofi’s global head of vaccines research and development Jean-François Toussaint 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 programme we aim to make chlamydia a preventable disease through vaccination.”

The Fast Track designation from the Food and Drug Administration (FDA) is handed to drugs that treat serious conditions and fill an unmet medical need. 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.

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.

Sanofi’s vaccine aims to protect against primary genital tract infection and reinfection caused by the bacterium Chlamydia trachomatis.

Meanwhile, the FDA has granted marketing authorisation to the first home test for three sexually transmitted infections (STIs).

Visby Medical’s Women’s Sexual Health Test covers chlamydia, gonorrhoea and trichomoniasis, is available without a prescription and can be performed entirely at home. It is intended for those with or without symptoms and delivers results in around 30 minutes.

Courtney Lias, director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, said: “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.”