Experimental Gonorrhea vaccine gets FDA fast-track as STI cases rise

An experimental vaccine that could wipe out the threat of gonorrhea has been fast-tracked by the Food and Drug Administration.

The sexually transmitted infection (STI) is the second most common in the US and is alarming officials because it is becoming resistant to antibiotics — which could make it much harder to treat.

Scientists at GlaxoSmithKline (GSK) are aiming to open up an alternative treatment by developing an injectable vaccine against the disease, although it is currently in phase II trials and will not shift to final testing until 2026 at the earliest.

Today’s designation from the agency could help to speed the approval of the vaccine and ensure that it gets to the public rapidly.

The agency’s designation means any data from clinical trials will be looked over quickly by staff and it could be approved faster (stock image)

The above shows how gonorrhea cases are rising 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 that have gonorrhea every year

The Neisseria gonorrhoeae investigational vaccine — its name from GSK — has already been through phase I trials which showed it was safe to use in humans.

Phase II trials were launched in November 2022 and involve 750 people between 18 and 50 years old who are at higher risk of catching gonorrhea. 

They are from eight countries including the US, UK, France and Spain.

Scientists do not expect results from this phase until March 2025, according to clinicaltrials.gov, at which point it will be able to move to phase III tests.

The vaccine is administered as an injection into the muscle, with patients being given two doses to trigger immunity.

GSK has not revealed how the vaccine works. But in previous cases, vaccines have been developed that use antigens from the surface of bacteria to trigger an immune reaction.

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 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.’

Concerns have been raised over gonorrhea because of its growing resistance to antibiotics, with all strains now impervious to one or more of the medicines.

Doctors are increasingly having to rely on ceftriaxone, which must be given via an injection, although there is also resistance emerging against this.

In Massachusetts last year, two cases of the STI that showed increased resistance to this antibiotic were detected. The pair were also not related, suggesting the strain is spreading undetected in the community.

There are also cases of resistant gonorrhea, dubbed super-gonorrhea, being detected in other countries including the UK and Italy.

This has raised the alarm in medical circles, who will then have to shift to antibiotics of last resort to treat the disease. 

Speaking to Bloomberg, former head of public health in San Francisco Jeffrey Klausner said: ‘We’re very concerned that we are staring straight in the face of untreatable gonorrhea.’

This map shows the gonorrhea infection rate per 100,000 people across the US in 2014

And this map shows how it has shifted by the year 2021 with infections rising across the country. Areas in the south have seen a particularly sharp rise

A vaccine could help to combat this growing threat by opening up a new avenue of treatment for doctors.

The immune system already attacks the bacteria when it triggers an infection in the mucous lining of the reproductive tract, including the cervix and uterus in women and the urethra — or tube inside the penis — in men. It can also infect the mucosa in the anus and throat.

Gonorrhea is spread via sexual contact with these areas, with patients suffering symptoms including a pain or burning sensation while urinating and a discharge from sexual organs up to two weeks after infection.

But about 50 percent of women and 10 percent of men with the infection do not develop symptoms, yet still transmit the bacteria to others.

Cases in the United States have been heading upward since the early 2000s and are now at their highest level since the 1990s.

An estimated 718,000 Americans have gonorrhea at present, up seven percent from last year when 670,000 had the infection.