GSK Plc’s experimental gonorrhea vaccine got fast-track designation from U.S. regulators, putting the shot in position to become the first preventive for a common, often-undetected infection that’s gaining resistance to treatment.
The Food and Drug Administration status makes the drug eligible for a sped-up approval process, if an ongoing midstage trial shows it’s effective, the company said Tuesday. GSK learned of its status in April and plans to move the vaccine to final-stage testing in 2026, said Giulia Giordano, vaccine development leader for the project.
In 2020, some 82 million people worldwide caught gonorrhea, a sexually transmitted infection that can lead to complications including infertility. While some patients show early symptoms, such as pain or urethral discharge in men or vaginal discharge in women, many cases may be missed even as the disease does long-term damage.
