GSK announced that the FDA 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 gonorrhea. 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.
Gonorrhea 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 gonorrhea 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: “We welcome the FDA's decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae infection. 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 Organisation.”
Antimicrobial resistance (AMR) to gonorrhea has increased over the past 80 years, rendering many classes of antibiotics used to treat the disease ineffective. Vaccines can play a critical role in the fight against AMR by helping prevent bacterial, viral and other infections. At this time, there are no gonorrhea vaccines approved anywhere in the world.
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