Investigational Gonorrhea Vaccine Gets FDA’s Fast Track Designation

The Food and Drug Administration (FDA) has granted Fast Track designation to GSK’s investigational vaccine for the prevention of Neisseria gonorrhoeae infection.

The vaccine candidate is being investigated in a phase 2 study (ClinicalTrials.gov Identifier: NCT05630859) in healthy adults 18 to 50 years of age who are considered at risk of gonorrhea. 

“We welcome the FDA’s decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae infection,” said Phil Dormitzer, Global Head of Vaccines R&D, GSK. “With a high and growing incidence, gonorrhea is a major concern for sexual and reproductive health around the globe. This designation recognizes the potential for a vaccine that could help protect millions of people across the world against the serious health consequences of infection with a bacterium that is considered a ‘high priority’ pathogen by the World Health Organization.”

According to the Centers for Disease Control and Prevention (CDC), there were 710,151 cases of gonorrhea reported to the CDC in 2021. Between 2009 and 2021, the rates of reported gonorrhea increased 118%.

The FDA’s Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments.