Is manufacture of new vaccines feasible, and how long will it take to produce what quantities? What are your assumptions about facilities, final dosage and yield at each stage of production? Which steps limit the volume and rate of production? How readily changed, if at all, is each rate-limiting step? What are the trade-offs (e.g., cost, reactivity)?
What quality control and other testing must be done at each stage of production?
What field trials should be conducted, with what dosages and types of vaccine, what number of doses, and in which population groups?
Vaccine benefits, risks and costs
What efficacy in terms of disease prevention and decreased mortality do you expect from the new vaccine, for which age groups?
How long will it take for inoculation to confer protection, and how long-lasting will it be. Air assumptions.
What side effects, of what type and severity, and in what frequency, do you foresee?
What additional surveillance will be required to detect different types and frequencies of side effects?
What do you estimate as the dollar cost of vaccine production and administration? What are the components of your estimate? Are there additional, indirect costs, as from litigation, which you anticipate? Air your assumptions.
Program objectives, organization, implementation
What vaccination objectives would you recommend in terms of total numbers to be vaccinated, dosages and schedules in different age groups, reaching what socioeconomic levels, over what time span, completed by when? State what you would like ideally. Then state what you would regard as satisfactory. Air your assumptions.
Given these aims, what alternatives do you see for administration of the following tasks as among federal, state and local agencies, private manufacturers, insurers, medical practitioners, voluntary agencies, other (specify in each case)?
Preparing recombinant and seed strains
Producing and distributing vaccine
Purchase of vaccine
Testing vaccine at different stages