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Table 2 Draft list of key data considerations information malaria vaccine decision-making based on documentation and WHO interviews

From: WHO policy development processes for a new vaccine: case study of malaria vaccines

Safety and efficacy in relevant populations Safety
An acceptable safety profile
Freedom from "rebound" effect, that is, enhancing disease incidence in target groups following use: needs follow-up population monitoring
Positive evaluation from WHO GACVS
No significant adverse impact on other malaria prevention and treatment strategies (i.e. increasing adverse events from another product) or on response to concomitantly administered vaccines
Safety evaluated in immunologically compromised groups, e.g. HIV-infected
Acceptable level of reduction of disease-related morbidity and/or mortality in target populations
Efficacy demonstrated in different malaria endemicity settings
Delivery schedules, dosing and administration route feasible and consistent with burden of disease in target countries
Implications for costs and population health Supply, financing, and cost-effectiveness issues
Availability of product under the regulatory oversight of a fully functional regulatory authority and/or prequalification
Available supply related to anticipated demand
Means of monitoring impact to feed into cost-effectiveness assessment
Prospects for competitive vaccine market
  Impact on other public health interventions
Vaccine delivery strategies to reach desired target groups (e.g., catch-up immunization where relevant)
Impact of vaccine use on compliance with other interventions, e.g. ITN
Community perception of given malaria vaccine products given their likely characteristics
Impact of the vaccine demonstrated in the context of other malaria control strategies
Localization of data Local applications of the intervention
Evidence sufficient for local decision making available to the appropriate in-country groups (such as Immunization Advisory Committee, Interagency Coordinating Committee, etc), including, as relevant, national stakeholders and decision makers and key partners
Ability to deliver vaccine through local cold chains
Specific evidence for unique epidemiological situations available, if applicable
Information from demonstration projects available particularly where new target groups or specific product acceptance issues are involved