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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