ARCHIVED - Recommendations on a Human Papillomavirus Immunization Program


Appendix 1

Worksheet – using the Analytical Framework


Disease Characteristics and Burden

  • Nature and characteristics of the infective agents
  • Clinical manifestations and complications
  • Epidemiology of the disease
  • Specific populations affected and risk factors
  • Current disease treatment and preventability
  • Social impact of the disease
  • Economic impact of the disease

Vaccine Characteristics

  • Nature and characteristics of immunizing agent
  • Characteristics of commercial products
  • Storage, handling, product format
  • Vaccine manufacturers, production capacity and supply
  • Administration schedule, number of doses, combination with other vaccines
  • Nature and characteristics of the immune response
  • Immunogenicity in different population groups
  • Short- and long-term direct and indirect protection
  • Impact on reduction of burden of disease
  • Safety: rates and severity of adverse effects, contra-indications, precautions
  • Potential interaction with other vaccines
  • Potential impacts on antibiotic resistance

Alternative Immunization Strategies and Programs

  • Existing recommendations/guidelines for use of the vaccine
  • Objectives of disease control/elimination/eradication at international, national, and/or provincial/territorial levels
  • Alternative immunization strategies for meeting objectives
  • Specific objectives in terms of reduction of incidence, complications, sequelae and mortality
  • Specific objectives re coverage of specific groups
  • Delivery strategy/system

Social and Economic Costs and Benefits

  • Total and opportunity costs of program for families and the health system
  • Evidence regarding short- and long-term effectiveness
  • Evidence regarding social and economic benefits
  • Other benefits
  • Economic evaluation: net present costs and cost-benefit ratios

Feasibility and Acceptability of Alternative Programs

  • Public perception of disease risk, severity, fear, need for control
  • Demand for/acceptability of immunization for target groups
  • Priority for approved program compared with other programs
  • Expected date of licensure or current use of vaccine
  • Integration of new program with existing programs and schedules
  • Impacts on existing immunizations services and the health care sector
  • Accessibility of target population/expected levels of uptake
  • Availability of vaccine supply
  • Availability of funding for vaccine purchase
  • Availability of human, technical and financial resources
  • Availability of appropriate documentation/consent forms
  • Availability of system for recording/registering vaccine administration
  • Availability of resources for marketing and communication
  • Existence of operational planning and implementation committee

Ability to Evaluate Questions

  • Desirability of evaluation to families, professionals
  • Availability of information systems to measure coverage, utilization, quality
  • Availability of information systems for monitoring reduction of disease incidence, complications, mortality
  • Availability of system for monitoring adverse events associated with vaccine administration
  • Availability of systems for linking health outcomes databases, immunization registries and population registries

Research Questions

  • Ongoing and planned research projects in the fields of vaccine development, immunogenicity, efficacy and safety
  • Identification of areas in previous sections in which research is needed to assist planning evaluation and decision-making

Other Considerations

  • Equity of new program, including universality, accessibility and gratuity of services for the most vulnerable population groups
  • Ethical considerations, including informed consent and protection of confidentiality of medical information
  • Conformity of new program with planned or existing programs in other jurisdictions and countries
  • Possible political benefits and risks associated with implementation of the new program

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