PMID- 20576114
OWN - NLM
STAT- MEDLINE
DCOM- 20100824
LR  - 20211020
IS  - 1475-2875 (Electronic)
IS  - 1475-2875 (Linking)
VI  - 9
DP  - 2010 Jun 24
TI  - WHO policy development processes for a new vaccine: case study of malaria 
      vaccines.
PG  - 182
LID - 10.1186/1475-2875-9-182 [doi]
AB  - BACKGROUND: Recommendations 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. METHODS: The 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 DESCRIPTION: WHO 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 
      EVALUATION: 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. 
      CONCLUSIONS: 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.
FAU - Milstien, Julie
AU  - Milstien J
AD  - 1University of Maryland School of Medicine, 3 bis rue des Coronilles Residence 
      Parc de Clementville Batiment C, 34070 Montpellier, France.
FAU - Cardenas, Vicky
AU  - Cardenas V
FAU - Cheyne, James
AU  - Cheyne J
FAU - Brooks, Alan
AU  - Brooks A
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100624
PL  - England
TA  - Malar J
JT  - Malaria journal
JID - 101139802
RN  - 0 (Malaria Vaccines)
SB  - IM
MH  - Costs and Cost Analysis
MH  - Developing Countries
MH  - Global Health
MH  - *Health Policy
MH  - Humans
MH  - Malaria/prevention & control
MH  - *Malaria Vaccines/economics/supply & distribution
MH  - *Policy Making
MH  - *World Health Organization
PMC - PMC2907394
EDAT- 2010/06/26 06:00
MHDA- 2010/08/25 06:00
PMCR- 2010/06/24
CRDT- 2010/06/26 06:00
PHST- 2010/03/22 00:00 [received]
PHST- 2010/06/24 00:00 [accepted]
PHST- 2010/06/26 06:00 [entrez]
PHST- 2010/06/26 06:00 [pubmed]
PHST- 2010/08/25 06:00 [medline]
PHST- 2010/06/24 00:00 [pmc-release]
AID - 1475-2875-9-182 [pii]
AID - 10.1186/1475-2875-9-182 [doi]
PST - epublish
SO  - Malar J. 2010 Jun 24;9:182. doi: 10.1186/1475-2875-9-182.