GSK receives FDA Fast Track designation for novel gonorrhoea vaccine
Betsy Goodfellow | June 27, 2023 | News story | Research and Development | FDA, GSK, Infections and infestations, Vaccine, fast track designation, gonorrhoea
GSK has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for its investigational vaccine for gonorrhoea, which is currently in an ongoing phase 2 trial assessing the efficacy of the vaccine in healthy adults aged 18 to 50 who are considered at risk of contracting gonorrhoea.
As gonorrhoea is the second most prevalent sexually transmitted infection (STI) worldwide, with around 82 million new cases globally each year, this Fast Track designation for the investigational vaccine 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 Neisseria gonorrhoeae 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 against the serious health consequences of infection with a bacterium that is considered a ‘high priority’ pathogen by the World Health Organization (WHO).”
Betsy Goodfellow
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