GSK plc announced that the US Food and Drug Administration (FDA) has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine (NgG). The vaccine candidate is currently in an ongoing phase II trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults, 18 to 50 years of age, considered at risk of gonorrhoea. Fast Track designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with unmet medical needs.
Gonorrhoea is the second most prevalent bacterial sexually transmitted infection (STI) worldwide, with an estimated 82 million new cases globally each year. In the US, rates of reported gonorrhoea have increased 118% from 2009 to 2021, resulting in 710,151 cases being reported to the US Centers for Disease Control and Prevention (CDC) in 2021.
Phil Dormitzer, global head of vaccines R&D, GSK, said:
