New Gonorrhea Vaccine Gets Fast-Track Review By FDA

There is hope for STD patients as a new gonorrhea vaccine has been approved for fast-track review by the Food and Drug Administration (FDA). 

The experimental Neisseria gonorrhoeae investigational vaccine (NgG), developed by British pharmaceutical company GSK plc, will be the first of its kind as the sexually transmitted disease (STD) has never had any preventive measures against it.

“We welcome the FDA’s decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae infection,” said Phil Dormitzer, who is the Global Head of Vaccines R&D at GSK. “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 Organization,” Dormitzer added. 

The Fast Track designation is a program that speeds up the process of developing new drugs meant to treat “serious or life-threatening conditions” and show the capability to “address unmet medical needs.” 

Although treatments have been available to cure the disease, bacteria within it have evolved to resist “nearly every drug used for treatment,” according to the Centers for Disease Control and Prevention. Treatments most commonly used are ceftriaxone, azithromycin and doxycycline. 

Gonorrhea is very common, with over 700,000 people infected in the U.S. annually, and is the second most widespread STD in the world. It can cause many health problems including pregnancy complications and infertility. There is also an increased risk of HIV, in both catching and spreading it. If left untreated, the CDC says it can spread to the blood or joints, which can be life-threatening.