Abstract

BackgroundIt is unclear how long it takes for health interventions to transition from research and development (R&D) to being used against diseases prevalent in resource-poor countries. We undertook an analysis of the time required to begin implementation of four vaccines and three malaria interventions. We evaluated five milestones for each intervention, and assessed if the milestones were associated with beginning implementation.MethodsThe authors screened World Health Organization (WHO) databases to determine the number of years between first regulatory approval of interventions, and countries beginning implementation. Descriptive analyses of temporal patterns and statistical analyses using logistic regression and Cox proportional hazard models were used to evaluate associations between five milestones and the beginning of implementation for each intervention. The milestones were: (A) presence of a coordinating group focused on the intervention; (B) availability of an intervention tailored to developing country health systems; (C) international financing commitment, and; (D) initial and (E) comprehensive WHO recommendations. Countries were categorized by World Bank income criteria.ResultsFive years after regulatory approval, no low-income countries (LICs) had begun implementing any of the vaccines, increasing to an average of only 4% of LICs after 10 years. Each malaria intervention was used by an average of 7% of LICs after five years and 37% after 10 years. Four of the interventions had similar implementation rates to hepatitis B vaccine (HepB), while one was slower and one was faster than HepB. A financing commitment and initial WHO recommendation appeared to be temporally associated with the beginning of implementation. The initial recommendation from WHO was the only milestone associated in all statistical analyses with countries beginning implementation (relative rate = 1.97, P < 0.001).ConclusionsAlthough possible that four milestones were not associated with countries beginning implementation, we propose an alternative interpretation; that the milestones were not realized early enough in each intervention’s development to shorten the time to beginning implementation. We discuss a framework built upon existing literature for consideration during the development of future interventions. Identifying critical milestones and their timing relative to R&D, promises to help new interventions realize their intended public health impact more rapidly.

Highlights

  • A decade after each studied vaccine or malaria intervention was approved by regulators, 33% or fewer low and lower-middle-income countries, and in most cases less than 15%, had begun to implement it

  • Malaria interventions were implemented sooner than vaccines, a mean percentage of 37% of countries at 10 years compared with only 4% for vaccines

  • No low-income country implemented any of the new vaccines in the first five years

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Summary

Introduction

It is unclear how long it takes for health interventions to transition from research and development (R&D) to being used against diseases prevalent in resource-poor countries. The GAVI Alliance (GAVI; formerly the Global Alliance for Vaccines and Immunization) and the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) were established in 2000 and 2002, respectively Since they have committed more than USD 20 billion to address the divergence in health status and access to health interventions between developed and developing countries (DCs). Product development partnerships (PDPs) have grown in number and are focused on developing drugs, rapid diagnostic tests, vaccines and other interventions for developing countries [2] The use of such interventions might eventually be subsidized by GAVI, GFATM, and other financing mechanisms. Beginning implementation does not guarantee, but is on the critical path to, interventions becoming widely accessible to people in need in developing countries

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