WHO Policy Development Processes for a New Vaccine: Case Study of Malaria Vaccines
This article, published in Malaria Journal, analyzed the World Health Organization policy development process to predict its course for a malaria vaccine. Data needs for a malaria vaccine include safety; the demonstration of efficacy in a range of epidemiological settings in the context of other malaria prevention interventions; and information on potential rebound in which disease increases subsequent to the intervention. In addition, a malaria vaccine would require attention to additional factors, such as costs and cost-effectiveness, supply and demand, impact of use on other interventions, and distribution issues. Although policy issues may be more complex for future vaccines, the lead-time between the date of product regulatory approval and a recommendation for its use in developing countries is decreasing. This study presents approaches to define in advance core data needs to support evidence-based decisions, to further decrease this lead-time, accelerating the availability of a malaria vaccine. Specific policy areas for which information should be collected are defined, including studying its use within the context of other malaria interventions.
Author(s): Milstien J, Cardenas V, Cheyne J, Brooks A
Download file (English)
723 KB PDF (Located at www.malariajournal.com)