Vaccine Development Process Maps

Coxiella burnetii

In each example which level applies is marked with colour and with (A).

Those with more information and notes can be found in the accordion below each section (Technical feasibility, Public Health value, time scale and cost of development). They are marked with the notepen notepen icon icon.

Technical feasibility

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 (A)notepen
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 (A)notepen
Can the pathogen be cultured in a laboratory Very difficult to culture Possible to culture, but lengthy and difficult process (A)notepen Can be cultured
Complexity and size of pathogen Large and complex pathogen Medium sized pathogen Small and simple pathogen (A)notepen
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 (A)notepen
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 (A)notepen
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 (A)notepen
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 (A) notepen

Public health value

Criterion Low priority Medium priority High priority
Infectivity or rate of spread of pathogen notepen Rapid spread with high attack rate 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 (A)notepen 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(A) Highly infectious before disease onset(A) notepen
Environmental factors Environmental factors are easily modulated Moderately difficult to address environmental factors Environmental factors cannot be modulated (A)notepen
Geographical spread Small isolated pockets of disease Moderately spread Large disseminated disease outbreak (A)notepen
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 (A)notepen
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 (A)notepen

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 (A)notepen