Vaccine Development Process Map

Prioritisation of Vaccine Development decision making guide

This guide is split into three sections, Technical feasibility, Public health value and Time scale and cost of Development. To guide you there are criterion under each main heading which are split into how feasible or how much of a priority that criterion is. Each is coded red for low, yellow for medium and green for high feasibility/priority.

To see how this guide was applied to current vaccines select one of the pathogens below to show selections made.

More information and notes can be found by selecting the notepen notepen icon.

Vaccine development decision guide (unpopulated)

Technical feasibility notepen

Technical feasibility

The feasibility of developing a vaccine in response to a previously unknown pathogen during the course of the first outbreak is low. However, the first outbreak will provide important information which will enable vaccine development for future outbreaks.

Criterion Low feasibility Medium feasibility High feasibility
Provenance of pathogen No understanding of provenance Some understanding of provenance, with limited understanding of epidemiology Known disease, with well understood epidemiology
Similarity to known pathogen Dissimilar, at least in initial analysis, to any known pathogen From a known family of pathogens Closely related to a well characterized pathogen
Can the pathogen be cultured in a laboratory Very difficult to culture Possible to culture, but lengthy and difficult process Can be cultured
Complexity and size of pathogen Large and complex pathogen Medium sized pathogen Small and simple pathogen
Antigenic  diversity High genetic diversity, with high mutation rate and lack of annotated genomic data Some genetic diversity with moderate mutation rate Little genetic diversity, with low mutation rate. Large amounts of well annotated genomic data available
Biomarkers for safety/efficacy No understanding of biomarkers for safety or efficacy Some understanding of biomarkers that may relate to safety/efficacy Clear understanding of biomarkers for both safety and efficacy
Host-immune response No known cases of natural immunity, and pathogen is immune modulatory Some cases of natural immunity, but unclear whether this is durable and protective. Pathogen is generally perceived as not being immune modulatory Cases of natural immunity which are both durable and protective, pathogen is not immune modulatory, and neutralising antibodies are protective
Available model organisms, including human challenge models Lack of suitable animal model, and/or suitable human challenge model  Suitable animal model and/or suitable human challenge model may require some development Suitable animal model, and/or suitable human challenge model is available 

Public health value

Infectivity or rate of spread of pathogen

Low priority except where there is the potential to prevent a pandemic by vaccinating populations outside the affected country(s). These pathogens may be a priority for vaccine development in advance of an outbreak.

Low priority except where there is the potential to prevent a pandemic by vaccinating populations outside the affected country(s). These pathogens may be a priority for vaccine development in advance of an outbreak.

Criterion Low priority Medium priority High priority
Infectivity or rate of spread of pathogen Rapid spread with high attack rate notepen Moderate rate of spread and attack rate Pathogen is poorly transmitted, spread is very slow, and attack rate is low
Case fatality rate/disability burden Low case fatality rate/ disability burden Moderate case fatality rate/disability burden High case fatality rate/disability burden
Infectivity before symptom onset Not infectious before the onset of symptoms May be infectious before the onset of disease Highly infectious before disease onset
Environmental factors Environmental factors are easily modulated Moderately difficult to address environmental factors Environmental factors cannot be modulated
Geographical spread Small isolated pockets of disease Moderately spread Large disseminated disease outbreak
Target population Lack of clarity on target population, with the level of prevention that is acceptable/desirable unclear Some clarity on target population and level of prevention desirable Clarity on target population and level of prevention desirable
Availability of potential  alternatives to vaccination There are good alternatives to vaccination currently available which can be rapidly deployed to control the disease outbreak Effective alternatives to vaccination could be rapidly developed Effective alternatives to vaccination are not currently available and are not on the horizon

Time scale and cost of development

Criterion Low priority Medium priority High priority
Available vaccine candidate(s) No vaccine in development and route map for getting to Phase I trials not yet developed Promising candidates exist, and means of rapidly developing to Phase I can be identified Suitable vaccine may be in late stages of development

Download pdf of Vaccine prioritisation guide.