The candidate vaccine from the British pharmacist GSK to treat the gonorrheahas received expedited designation (Fast Track) by the United States Food and Drug Administration (FDA) this Tuesday. Currently, the NgG vaccine is in a phase II trial Aimed at healthy adults 18 to 50 years of age, considered at risk of gonorrhea. For its part, the Fast Track designation aims to facilitate the development and speed up the review of new drugs and vaccines potentially important in treating or preventing serious conditions with unmet medical needs.
Gonorrhea is the second sexually transmitted bacterial infection (ITS) most prevalent worldwide, with an estimated 82 million new cases worldwide per year. In the United States, reported gonorrhea rates increased by 118% between 2009 and 2021, which resulted in 710,151 reported cases by the Centers for Disease Control and Prevention (CDC) in 2021. Given a scenario marked by the need for solutions to gonorrhea, the results recorded by the GSK candidate vaccine have allowed it to receive the expedited designation.
“This designation recognizes the potential for a vaccine that could help protect millions of people around the world against the serious health consequences of infection with a bacterium that is considered a high-priority pathogen by the WHO.”
“We welcome the FDA’s decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae. This designation recognizes the potential of a vaccine that could help protect millions of people around the world against the serious health consequences of infection with a bacterium that the WHO considers a “high priority” pathogen, it says Phil Dormitzerglobal head of vaccine research and development at GSK.
In addition, from GSK they point out that the antimicrobial resistance of gonorrhea has increased over the past 80 years, making many classes of antibiotics used to treat the disease ineffective. Therefore, vaccines can play a fundamental role in the fight against resistance, by helping in the prevention of bacterial, viral and other infections. Although it is true, there are still no approved vaccines anywhere in the world against this disease.
2023-06-27 15:25:00
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