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

Malaria Journal

Case Study

Vicky Cárdenas¹  James Cheyne²  Alan Brooks²  Julie Milstien³ 

[1] PATH Malaria Vaccine Initiative, 7500 Old Georgetown Road, #1200, 20814, Bethesda, MD, USA;PATH, 13 Chemin du Levant, 01210, Ferney-Voltaire, France;University of Maryland School of Medicine, 3 bis rue des Coronilles Résidence Parc de Clémentville Bâtiment C, 34070, Montpellier, France;

关键词: Malaria;    Malaria Vaccine;    Policy Position;    Pneumococcal Conjugate Vaccine;    Oral Polio Vaccine;   

DOI  :  10.1186/1475-2875-9-182

 received in 2010-03-22, accepted in 2010-06-24,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundRecommendations from the World Health Organization (WHO) are crucial to inform developing country decisions to use, or not, a new intervention. This article analysed the WHO policy development process to predict its course for a malaria vaccine.MethodsThe decision-making processes for one malaria intervention and four vaccines were classified through (1) consultations with staff and expert advisors to WHO's Global Malaria Programme (GMP) and Immunization, Vaccines and Biologicals Department (IVB); (2) analysis of the procedures and recommendations of the major policy-making bodies of these groups; (3) interviews with staff of partnerships working toward new vaccine availability; and (4) review and analyses of evidence informing key policy decisions.Case descriptionWHO policy formulation related to use of intermittent preventive treatment in infancy (IPTi) and the following vaccine interventions: Haemophilus influenzae type b conjugate vaccine (Hib), pneumococcal conjugate vaccine (PCV), rotavirus vaccine (RV), and human papillomavirus vaccine (HPV), five interventions which had relatively recently been through systematic WHO policy development processes as currently constituted, was analysed. Required information was categorized in three areas defined by a recent WHO publication on development of guidelines: safety and efficacy in relevant populations, implications for costs and population health, and localization of data to specific epidemiological situations.Discussion and evaluationData 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.ConclusionsAlthough 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.

【 授权许可】

Unknown   
© Milstien et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.