Disease Burden
Epidemiology
Vaccine Safety
Efficacy
Effectiveness
Cost-effectiveness
Quality
Anticipated impact of the immunization program
Vaccines risk vs benefit for each target population
Feasibility and scheduling (how the vaccine would fit into the national immunization schedule)
Comparison of the impact of the vaccine with other interventions
Demand forecast for the vaccine
Regular and timely vaccine supply to meet the demand forecast
Disease’s visibility in society and how it compares to other public health concerns
Implementation costs of the new vaccine for pregnant women
Current immunization program’s performance (to identify areas that need to be strengthened)
Adequate infrastructure needed to monitor the disease burden and vaccine safety (maternal, fetal and infant adverse events)
Regulatory and ethical considerations