GSK’s novel gonorrhoea vaccine gains Fast Track designation from FDA
As gonorrhoea is the second most prevalent sexually transmitted infection (STI) worldwide, with around 82 million new cases globally each year, the acceleration of vaccine development though the Designation will allow a large percentage of the global population access to an increasingly prevalent drug.
As well as cases in the US increasing 118% from 2009 to 2021, antimicrobial resistance (AMR) to gonorrhoea has also increased over the last 80 years, meaning many antibiotics used against it are now ineffective. With this in mind, vaccines against the STI could help prevent the increasing cases.
Phil Dormitzer, global head of vaccines research and development at GSK, commented:
“We welcome the FDA's decision to grant Fast Track designation for our new vaccine candidate against
infection. With a high and growing incidence, gonorrhoea is a major concern for sexual and reproductive health around the globe. This designation recognises the potential for a vaccine that could help protect millions of people across the world a gainst the serious health consequences of infection with a bacterium that is considered a ‘high priority’ pathogen by the World Health Organization (WHO).”