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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
  Efficacy 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 Affordability 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