Table 3.

Overview of non-commercial stakeholders engaged, their interest and potential demand for gonococcal vaccines.

Stakeholders engaged	Summary of position/interest	Potential demand and uptake	References
WHO	The rapidly changing antimicrobial susceptibility of N. gonorrhoeae has created an important public health problem.	N. gonorrhoeae is on WHO’s priority list of AMR pathogens, categorised as a high-priority pathogen for research and development efforts.	WHO Global Health Sector Strategies on HIV, Virus Hepatitis and STIs, 2022–2030
	The WHO Global Health Sector Strategies on HIV, Viral Hepatitis and STIs, 2022–2030 recognises N. gonorrhoeae as one of the main STIs requiring immediate action for control due to the rising risk of untreatable gonorrhoea and risk of coinfection with other STIs.	The WHO Global Health Sector Strategies on HIV, Viral Hepatitis and STIs outlines the need to accelerate access to innovations by developing new preventive interventions, including vaccines. The WHO PPCs for gonococcal vaccines provides guidance on WHO’s preferences for emerging gonococcal vaccines, including from the perspective of low to middle-income countries.	WHO Global Action Plan to Control the Spread and Impact of AMR in Neisseria gonorrhoeae, 2012 Global Health Sector Strategy on WHO Global Gonococcal Antimicrobial Surveillance Programme (GASP) [3,7,93–95]
Wellcome Trust (supported by Boston Consulting Group)	The case for developing a vaccine targeting N. gonorrhoeae is strong due to high incidence, high morbidity, and current circulation of resistant strains. Although significant development challenges remain, evidence of MenB vaccine cross-protection has fostered fresh optimism in the expert community.	AMR is a major concern globally, with the treatment of N. gonorrhoeae becoming increasingly challenging. Vaccines play an important role in reducing the demand for antibiotics, mitigating the risks for the inadequacy of the current pipeline.	Boston Consulting Group-Wellcome Report on Vaccines to Tackle Drug Resistant Infections [97]
Pan American Health Organization (PAHO)	Neisseria gonorrhoeae Antimicrobial Resistance Surveillance: Consolidated Guidance Prevention, early diagnosis, and effective treatment are essential for the control and elimination of N. gonorrhoeae as a public health problem. An epidemiological alert was issued by PAHO in 2018 regarding the emerging cephalosporin resistance in N. gonorrhoeae, advising countries to strengthen AMR prevention.	PAHO serves as the Regional Office for the Americas of the WHO and has worked alongside WHO to develop the Global Health Sector Strategies on HIV, viral hepatitis and STIs and the WHO preferred product characteristics for gonococcal vaccines.	[96]
European Commission European Centre for Disease Prevention and Control (ECDC) The European Gonorrhoea Response Plan Group	European Gonococcal Antimicrobial Surveillance Programme has reported gonococcal infections with resistance to cefixime and ceftriaxone, particularly a rapidly increasing resistance to azithromycin. The spread of resistance against cephalosporins, the main recommended antibiotic class for gonorrhoea therapy across Europe, is extremely concerning.	In the absence of an effective vaccine, condom use, early diagnosis and treatment, and other conventional public health measures remain the main public health strategies to interrupt transmission and avoid co-morbidities of gonococcal infection. The response plan for multi-drug resistant and XDR gonorrhoea developed by the ECDC focuses on strengthening AMR surveillance, treatment failure monitoring and establishing a communication strategy to inform European authorities of the results from AMR surveillance.	[98,99]
U.S. Federal Task Force on Combating Antibiotic-Resistant Bacteria	The National Strategy for Combating Antibiotic Resistant Bacteria identifies priorities and coordinates investments to prevent, detect, and control outbreaks of resistant pathogens recognized by CDC as urgent or serious threats, including ceftriaxone-resistant N. gonorrhoeae. Effective vaccines may potentially reduce the need for antibiotics and prevent resistance from developing in the first place.	The National Action Plan for Combating Antibiotic-Resistant Bacteria, 2020–2025 states the US government will pursue activities to enhance translational and clinical research on vaccines for antibiotic-resistant bacteria	[100,101]
National Institute of Allergy and Infectious Diseases (NIAID), U.S.	The National Institute for Allergy and Infectious Diseases (NIAID) has continuously been engaging with WHO to address the gaps in knowledge about advancing STI vaccine development, including vaccines for N. gonorrhoeae. In 2015, NIAID sponsored the workshop “Gonorrhea Vaccines: the Way Forward” to discuss key questions on the current status of gonorrhoea vaccine research and the path forward. The workshop identified that broader access to in vitro assays, reagents, and animal models could potentially improve collaboration and acceleration of the vaccine development process. Efforts to refine existing animal models and leverage the experimental human male infection model for phase I/II trials should also continue. In addition, continuing clinical studies can help develop a better understanding of the natural history of gonococcal infection.	The National Institute for Allergy and Infectious Diseases has been working with WHO to implement the Global STI Vaccine Roadmap, [106] which includes key activities to advance gonococcal vaccine development. One such activity is developing WHO PPCs to reflect WHO guidance on desired vaccine parameters to meet priority public health goals, especially for LMICs.	US NIAID Workshop: Gonorrhoea Vaccines: the Way Forward, 2015 [102]
National Institute for Communicable Diseases/National Health Laboratory Services STI Reference Centre	The NICD/NHLS plays a leading role in sub-Saharan Africa’s WHO Gonococcal Antimicrobial Surveillance Programme.	Within South Africa, the STI Reference Centre at NICD/NHLS developed and has coordinated the National Microbiological Surveillance Programme for STIs since 2005. Local AMR gonococcal surveillance across the nine provinces of South Africa (since 2006) has informed STI management and control guidelines. Surveys have confirmed widespread ciprofloxacin resistance among gonococci. Renewed efforts from WHO and NICD/NHLS to develop African GASP started in 2010. The STI Reference Centre designed and implemented a protocol to determine gonococcal resistance in gonococci isolated from men with urethral discharge in Zimbabwe. Site visits were also undertaken to the National Reference Laboratory in Madagascar and Tanzania to discuss survey protocol issues and training needs.	[103]
Australian Government Department of Health	The Australian Government Department of Health provides leadership for coordinating the national response to blood-borne viruses and STIs through a number of national strategies and initiatives. New technologies and innovative approaches such as vaccines are required to enhance the impact and produce better health outcomes for people with or who are at risk of STIs.	The National Antimicrobial Resistance Strategy 2020 states that an effective research response to antimicrobial resistance needs to include research of therapeutic alternatives to antimicrobials, such as vaccines. Further research is the only way to inform the development of improved preventative measures.	[104,105]