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Analysis of WHO Policy Development Processes for a New Intervention Analysis of WHO Policy Development Processes for a New Intervention Malaria Vaccines May 2008 7500 Old Georgetown Road, Suite 1200 Bethesda, MD 20814 USA Tel: 240.395.2700 Fax: 240.395.2591 www.malariavaccine.org This document was prepared and written under a consultancy agreement between the PATH Malaria Vaccine Initiative (MVI) and the report’s lead author, Dr. Julie Milstien. Mr. Alan Brooks, MVI, was the project originator, manager and a contributing secondary author. Dr. Vicky Cardenas, MVI, and Mr. James Cheyne, PATH Immunization Solutions were also contributing secondary authors. Over the course of the project, other people have participated in review meetings and have otherwise contributed valuable material and comments. In particular, the author would like to thank the following staff from the World Health Organization: Immunization Vaccine and Biologicals: Dr. Zarifah Reed, Dr. Philippe Duclos Global Malaria Program: Dr. Kamini Mendis While WHO staff have reviewed and contributed to this report, the findings pertaining to malaria vaccines do not reflect an official WHO position or policy. This report was supported through a grant from the Bill & Melinda Gates Foundation. Analysis of WHO Policy Development Processes for a New Intervention: Malaria Vaccines PATH Malaria Vaccine Initiative, May, 2008 Table of Contents Executive Summary........................................................................................................................ 5 Introduction..................................................................................................................................... 7 Methods........................................................................................................................................... 7 Findings........................................................................................................................................... 8 WHO Policy Guidance ............................................................................................................... 8 WHO Policymaking Bodies........................................................................................................ 8 Previous Policies for Malaria Treatment and Prevention Interventions ................................... 10 Vaccine Policy Development.................................................................................................... 16 Implications for Policymaking for a Malaria Vaccine.............................................................. 25 Conclusions................................................................................................................................... 29 Annex 1. Individuals Consulted.................................................................................................... 40 Annex 2. Documents Consulted ................................................................................................... 41 WHO Policies and Governance ................................................................................................ 41 WHO Websites ......................................................................................................................... 41 Malaria Treatment Policies....................................................................................................... 41 Malaria Prevention Policies ...................................................................................................... 41 Vaccine Policies........................................................................................................................ 42 3 Analysis of WHO Policy Development Processes for a New Intervention: Malaria Vaccines PATH Malaria Vaccine Initiative, May, 2008 Acronyms ACT Artemisinin-based combination therapy EPI Expanded Program on Immunization GACVS Global Advisory Committee on Vaccine Safety (WHO) GIVS Global Immunization Vision and Strategy (WHO) GMP WHO Global Malaria Programme GSK GlaxoSmithKline Biologicals HEAG HPV Expert Advisory Group (WHO) Hib Haemophilus influenzae type b (vaccine) HPV Human Papilloma Virus (vaccine) ITNs Insecticide-treated nets IPTi Intermittent preventive treatment in infants IPTp Intermittent preventive treatment in pregnancy IVB WHO Immunization, Vaccines, and Biologicals IVR Initiative on Vaccine Research (IVR) MALVAC Malaria vaccine advisory committee (WHO) MVI PATH Malaria Vaccine Initiative OPV Oral polio vaccine PnuemoADIP Pneumococcal vaccines Accelerated Development and Introduction Plan SAGE Strategic Advisory Group of Experts (IVB) SP Sulfadoxine-pyramethamine STAG Strategic Technical Advisory Group (GMP) TEG Technical Expert Group (GMP) WHO World Health Organization 4 Analysis of WHO Policy Development Processes for a New Intervention: Malaria Vaccines PATH Malaria Vaccine Initiative, May, 2008 Analysis of WHO Policy Development Processes for a New Intervention Executive Summary The PATH Malaria Vaccine Initiative (MVI) commissioned this analysis to begin elucidating the World Health Organization (WHO) process for developing policy guidelines for a malaria vaccine. The analysis considered past WHO recommendations on new interventions and assessed potential implications for a malaria vaccine. MVI and its partners may use guidance on these data requirements and timing to inform policy and research activities over the coming years, while WHO considers its specific requirements. This analysis cut across at least two WHO departments: the Global Malaria Programme (GMP) and Immunization, Vaccines and Biologicals (IVB). It was conducted in consultation with staff and expert advisors to these two departments. It included review and analyses of the information available at the time key policy decisions were made. The workings of the two major policymaking bodies of the GMP and IVB were also analyzed, along with recommendations developed by their respective expert advisory groups in areas related to the prevention and treatment of malaria and the use of newer vaccines. Four malaria interventions and four vaccine interventions were analyzed in detail to understand the chronology of the data available at the time usage recommendations were considered by WHO policymaking bodies. To facilitate comparison across WHO departments, findings were analyzed according to categories defined by a WHO publication outlining the guidelines-development process. The categories are: Safety and efficacy in relevant populations. Implications for costs and population health. Localization of data to specific epidemiological situations. The results indicated that all three categories were important in the development of policy recommendations for the interventions analyzed. This was especially true for immunization interventions. These categories will likely be critical for data collection and recommendations concerning a malaria vaccine as well. This analysis identifies data needs specific to a malaria vaccine. These data points relate to the demonstration of a range of efficacies; safety issues such as rebound; the duration of immunity and the need for boosting; the impact of the epidemiological setting (e.g., endemic or seasonal malaria); and unique regulatory issues related to approval if a vaccine is for use only in developing countries. The findings lead to the following conclusions: 5 Analysis of WHO Policy Development Processes for a New Intervention: Malaria Vaccines PATH Malaria Vaccine Initiative, May, 2008 Although efficacy and safety in the relevant target population—including displacement of disease to another susceptible age group—are the essential components of any policy- and guidelines-development process, additional factors may also be important. These include issues related to costs and population health, such as supply and demand, financing issues, cost-effectiveness, and the impact of use on other interventions; issues specific to the local situation, such as the proposed schedule in the context of national policies and disease incidence; distribution issues depending on the age range of the target population; and specific advocacy and communications issues. It will be critical to document the ability to use a malaria vaccine in the context of other malaria treatment and prevention interventions, and to rigorously document the impacts. Demonstration projects or pilot introduction studies in endemic countries will be important to better understand the impact of vaccine introduction on other interventions, on the overall health system, and on perceptions of other vaccines. The format of policy presentations will need to comply with the principles set by a WHO guideline review committee, with classification of data according to the three WHO publication categories described above. Because the policy development process typically takes several iterations, only limited progress can be expected during each individual meeting. The concerns of the advisory groups can be anticipated to some extent and addressed thoroughly in subsequent presentations. For a product such as a malaria vaccine with a complex policy development process, a working group convened specifically for this purpose may be useful to assist both GMP and IVB policy groups. Such an approach was found productive for both pneumococcal conjugate and human papillomavirus (HPV) vaccines, although the mechanisms of convening these two groups differed (see text). Specific issues unique to a malaria vaccine spelled out in the text will need additional consideration (see section titled
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