Table 10.
Intervention |
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Gonococcal vaccines | MenB vaccines with potential cross-protection | |
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Possibility of implementation within existing delivery systems | High to very high (young adolescents) | High to very high (young adolescents) |
Low to moderate (older young people and populations at higher risk) | Low to moderate (older young people and populations at higher risk) | |
Vaccines targeted to young adolescents before their sexual debut could be implemented with existing adolescent vaccination programs, including school-based programs, e.g., with the HPV vaccine. Targeting this population without needing boosters before the period of highest risk will require a sufficient duration of protection. No vaccine delivery systems currently exist for other target populations for gonococcal vaccines; however, a variety of sexual health service platforms, e.g., PrEP clinics for HIV prevention, could be leveraged for vaccination programs. Experience with COVID-19 vaccine implementation might also improve reaching these groups. |
The same considerations according to target populations apply for MenB vaccines as for standalone gonococcal vaccines. However, in settings where MenB vaccines are already recommended and delivered in overlapping target groups for gonococcal infection, incorporation into existing programs would be more easily facilitated. | |
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Commercial attractiveness | Low | Moderate to high |
Both HIC and LMIC targets exist; however, target populations in HICs are typically small (key populations). Target populations in LMICs tend to be larger (e.g., some countries have high general population prevalence); however, the burden of infection and disease is not well defined in most LMIC settings. Gavi support will depend on cost-effectiveness in different settings. Increasing AMR would increase commercial attractiveness in all settings. |
Gaining an additional indication for an existing vaccine would only increase its potential for use and cost-effectiveness in different settings. The burden and overlap between MenB disease and gonococcal infection have not been well defined in all settings. In addition, target populations may not overlap. Increasing AMR would increase commercial attractiveness in all settings. |
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Clarity of licensure and policy decision pathway | Low to moderate | Moderate to high |
The licensure pathway is relatively clear, although an infection indication is preferred over a disease indication for various reasons, e.g., the role of asymptomatic infections in propagating AMR and difficulties in measuring upper genital tract disease in clinical trials. Regulators often prefer disease indications, although not uniformly. Policy decisions may vary greatly in HICs vs LMICs and among countries in both settings, based on several factors, including epidemiology and cost-effectiveness, as well as AMR. |
Given that MenB vaccines are already licensed for another condition, a lower efficacy could be acceptable for broadening the use of MenB vaccines to prevent gonococcal infection compared with the use of a standalone gonococcal vaccine, particularly for settings with a history of MenB endemic disease and/or outbreaks. | |
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Expected financing mechanism | Low to moderate | Moderate |
Interest from global funders, including Gavi, is unclear and will likely depend on data related to disease burden, cost-effectiveness, and importantly, AMR. There is limited country-level data on gonococcal epidemiology and disease burden to inform decision-making by national procurement agencies once the vaccines are available. |
Cost-effectiveness, and therefore interest from global funders, would likely increase with expanding indications for MenB vaccines. Again, there is limited data on country-level disease burden and epidemiology, and overlap of the two conditions, which will be required for decision-making by national procurement agencies. |
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Ease of uptake | Moderate | High |
For adolescents, a well-defined target population exists, as for HPV vaccines. However, in many settings, vaccine hesitancy has been an issue for HPV vaccines, which are widely seen as cancer-prevention vaccines; gonococcal vaccines will likely be more clearly associated with a sexually transmitted infection, which may affect acceptability, particularly to parents of adolescents. | The likelihood of acceptability is higher for MenB vaccines that have additional efficacy against gonorrhoea. Meningitis may be perceived as less stigmatizing than gonococcal infection. |
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Acceptability is likely higher for specific populations at greater risk for gonorrhoea; however, these populations may not be as well defined or as easy to access (e.g., MSM in LMICs). |