An experimental vaccine that could eliminate the threat of gonorrhea has been accelerated by the Food and Drug Administration.
The sexually transmitted infection (STD) is the second most common in the US and is troubling to officials because it is becoming resistant to antibiotics – which could make it much more difficult to treat.
Scientists at GlaxoSmithKline (GSK) are pursuing an alternative treatment by developing an injectable vaccine against the disease, though it is currently in phase II trials and won’t move to definitive testing until 2026 at the earliest.
Today’s designation by the agency could help speed up the vaccine’s approval and ensure it gets to the public quickly.
The agency’s designation means that all data from clinical trials is quickly reviewed by staff and can be approved more quickly (stock image)
The above shows how gonorrhea cases are on the rise in the US. They are now at their highest level since the 1990s. The data is given as the infection rate per 100,000 people
And the above shows the total number of Americans who have gonorrhea each year
The investigational vaccine Neisseria gonorrhoeae – the name comes from GSK – has already undergone phase I trials that showed it was safe for use in humans.
Phase II trials were launched in November 2022 and include 750 people between the ages of 18 and 50 who are at higher risk of contracting gonorrhea.
They come from eight countries, including the US, UK, France and Spain.
Scientists do not expect results from this phase until March 2025 clinical trials.govafter which it can move to phase III testing.
The vaccine is given as an injection into the muscle, with patients receiving two doses to boost immunity.
GSK has not disclosed how the vaccine works. But in previous cases, vaccines have been developed that use antigens from the surface of bacteria to trigger an immune response.
Phil Dormitzer, Global Head of Vaccine Development at GSK, said: “We welcome the FDA’s decision to grant Fast Track designation to our new vaccine candidate against Neisseria gonorrhoeae infection.
“With a high and growing incidence, gonorrhea is a major sexual and reproductive health problem around the world.
“This designation recognizes the potential of a vaccine that could help protect millions of people around the world from the serious health consequences of infection with a bacterium that is considered a high-priority pathogen by the World Health Organization.”
Concerns have been raised about gonorrhea due to growing antibiotic resistance, with all strains now refractory to one or more of the drugs.
Doctors are increasingly reliant on ceftriaxone, which must be administered by injection, although there is also resistance to this.
Two cases of the STI were discovered in Massachusetts last year that showed increased resistance to this antibiotic. The pair were also unrelated, suggesting the species has been spreading unnoticed in the community.
There are also cases of drug-resistant gonorrhea, called super gonorrhea, being discovered in other countries, including the UK and Italy.
This has raised the alarm in medical circles, which will then have to switch to antibiotics as a last resort to treat the disease.
Speak against Bloombergsaid former San Francisco public health chief Jeffrey Klausner, “We are very concerned that we are staring untreatable gonorrhea right in the face.”
This map shows the number of gonorrhea infections per 100,000 people in the US in 2014
And this map shows how things have shifted by the year 2021, with infections rising across the country. Areas in the south have seen a particularly strong increase
A vaccine could help combat this growing threat by opening up a new treatment route for doctors.
The immune system already attacks the bacteria when it causes an infection in the lining of the reproductive tract, including the cervix and uterus in women and the urethra — or tube in the penis — in men. It can also infect the mucous membrane in the anus and throat.
Gonorrhea is spread through sexual contact to these areas, with patients experiencing symptoms such as pain or a burning sensation during urination and discharge from the genitals for up to two weeks after infection.
But about 50 percent of women and 10 percent of men with the infection develop no symptoms, but still transmit the bacteria to others.
The number of cases in the United States has been rising since the early 2000s and is now at its highest level since the 1990s.
It is estimated that 718,000 Americans currently have gonorrhea, seven percent more than last year when 670,000 had the infection.