First Ever Gonorrhea Vaccine Gets FDA's Fast-Track Status

Decision to fast-track the vaccine’s path to US FDA submission accelerates GSK's gonorrhea vaccine development.

Highlights:

Gonorrhea is the second most prevalent bacterial sexually transmitted infection worldwide with an estimated 82 million new cases added globally each year
At present, there are no vaccines approved anywhere in the world for gonorrhea. GSK’s investigational vaccine is one of the first vaccine targeting Gonorrhea
The US Food and Drug Administration (FDA) has granted a Fast Track designation for its GSK’s investigational vaccine (NgG). The vaccine is currently in an ongoing Phase II trial

Gonorrhea
Gonorrhea is a very common sexually transmitted disease (STD) caused by a bacterium/superbug called Neisseria gonorrhoeae. It is spread during sexual intercourse- vaginal, oral, and anal.

‘GSK's first ever investigational vaccine for Gonorrhea, granted FDA fast track status as cases rapidly rise. #vaccine#gonorrhea’

Gonorrhea: The Disease Burden

Gonorrhea is a sexually transmitted disease (STD) that can infect the genitals, rectum and throat. It is very common, especially in western countries, among young people aged 15-24 years. In the year 2021, a total of 710,151 cases of gonorrhea were reported, making it the second most common notifiable STD in the US for that year. Reported cases of gonorrhea have increased by 118% since a historic low in 2009. Gonorrhea infection in women is often asymptomatic and under-diagnosed. Untreated infection can lead to complications and long-term consequences such as pelvic inflammatory disease, infertility, ectopic pregnancy, and adverse pregnancy outcomes.

Antibiotics remain the first line treatment for gonorrhea however, it is becoming harder to treat gonorrhea, as antimicrobial resistance among the drug-resistant strains of gonorrhea is increasing. Centre for Drug Control (CDC) notes that with the emergence of cephalosporin-resistant gonorrhea, the successful treatment of gonorrhea has become complicated. Currently, we have very few antibiotic options left that are well-studied, well-tolerated and highly effective. In such a situation, it is critical to continuously monitor drug resistance and encourage research and development of newer treatment options ().

Gonorrhea Vaccine Key Discovery Raises Hope for Treatment
Pathogens that cause gonorrhea is highly resistant to current treatments. Discovery of a pair of sensitive proteins may lead to new vaccine development.

Gonorrhea vaccine: The need of the hour

Currently, efforts to develop a preventive gonorrhea vaccine are critical. Till date, only two gonorrhea vaccines, have progressed to clinical trials. Despite robust responses in both trials, neither vaccine provided protection against gonorrhea after immunization ().

In the last few years, vaccine progress has been slow. One of the difficulties is that Gonorrhea infection rarely leads to an adaptive immune response. As per studies, mechanisms of protection against gonorrhea are unknown and hence the evaluation of a potential efficacious vaccine is challenging ().

Antibiotics to Develop Resistance for Gonorrhea Treatment
Gonorrhea is a sexually transmitted disease which is now becoming untreatable due to the resistant developed to the antibiotics.

GSK’s Gonorrhea Vaccine: Novel Solution Offered

The investigational vaccine (NgG), marketed by pharmaceutical company GSK is currently in an ongoing phase 2 trial
It will receive an expedited review by FDA officials after the decision to fast track its submission to the FDA
The phase 2 trial began in November 2022 and included 750 participants from eight countries
Phase I of the study was a dose-escalation and safety study conducted in healthy adults and is now complete
The current trial aims to assess the efficacy of the vaccine in healthy adults in the age 18 to 50 years who are considered at risk of Gonorrhoea infection
The FDA's Fast Track program aims to review new drugs and vaccines for serious conditions and hasten the development of the same
The fast track designation recognizes the potential of this vaccine against the serious health consequences of infection with a bacteria which is considered a 'high priority' pathogen by the World Health Organization (WHO) (4^✔ ✔Trusted Source
Investigational gonorrhea vaccine receives FDA Fast Track designation

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Phil Dormitzer, Global Head of Vaccines Research & Development GSK, in the recent press briefing commented that they welcome the FDA's decision to grant fast track designation for their novel investigational vaccine candidate. However, what results and impact this vaccine will have in the long run is for time to tell. All we can hope is that this vaccine will prove to be a critical tool for more sustainably preventing Gonorrhea infection at large. However, the best way to stop these infections from rising is by ensuring rapid, high-quality treatment standards, educating individuals and maintaining strong disease surveillance.

References:

Gonorrhea – CDC Basic Fact Sheet - (https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea.htm)
Vaccines for gonorrhea: can we rise to the challenge? - (https://pubmed.ncbi.nlm.nih.gov/21687431/)
Proteomics, Bioinformatics and Structure-Function Antigen Mining For Gonorrhea Vaccines - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6288298/)
Investigational gonorrhea vaccine receives FDA Fast Track designation - (https://www.cidrap.umn.edu/antimicrobial-stewardship/investigational-gonorrhea-vaccine-receives-fda-fast-track-designation)

Source-Medindia

One Step Closer to Developing Gonorrhea Vaccine
Understanding the mechanism behind a multicomponent protein complex known as beta-barrel assembly machinery (BAM) helps develop new therapies for gonorrhea.