TABLE 1-1

Representative Stakeholder Priority Areas

Stakeholders

Representative Priorities or Interest Areas

Public Sector: Health agencies; preparedness and response units; public health units; regulatory agencies; basic research divisions; domestic and foreign policy agencies; and military.

• Disease burden and health impact.

• Non-market and non-economic benefits of vaccines.

• Costs relating to vaccine development and delivery.

• Long-term benefits to the vaccine development enterprise, including (a) effective combination vaccines and (b) strategies to optimize existing or new production and delivery platforms.

• Ability to produce and administer a vaccine promptly for novel threats.

• Innovative methods for administration, including self-administration.

• Vaccines with long shelf life and ease of storage and management.

• Low number of doses and longevity of protection.

• Development of tracking systems from manufacturing plant to recipients in the field.

• Development of a scientific base for a new vaccine.

• Budgetary constraints for new vaccine research and development.

• Programmatic and operational aspects of administering new vaccines.

• Fitting new vaccines into existing vaccination schedules.

• Building harmony among general public, medical community, public health community, research community, manufacturers, and other international partners.

• Identification of disease and vaccine candidates that should not be prioritized.

Private Sector: Vaccine and biopharmaceutical industry.

• Development of desired product profiles that clearly describe target population and subpopulation segments, potential indications, and key product attributes.

• Consideration of uncertainty around licensure and identify clinical endpoints that will be used by regulators to assess vaccine efficacy, adjuvants, and key product attributes.

• Global need for certain vaccines with volume and price considerations.

• Financial burden due to clinical trials and barriers to successful licensing of a vaccine.

• Cost of development and projected time to economic return.

• Status of competition for a vaccine in developing and developed country markets.



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