The Framework for Policy Decision on the RTS,S/AS01 malaria vaccine: the use of emerging data to inform global policy on the first malaria vaccine

The World Health Organization (WHO)-coordinated Malaria Vaccine Implementation Programme (MVIP) supported pilot introductions of the RTS,S/AS01 malaria vaccine by the ministries of health through the childhood immunization programmes in Ghana, Kenya and Malawi from 2019 through 2023. The MVIP was designed to consolidate the vaccine’s safety, and to document the feasibility of implementation and impact in routine use. A 46-month period of surveillance was estimated to be sufficient to measure these outcomes, and to assess an impact on mortality. Before vaccine introduction in the three countries, a Framework for Policy Decision (Framework) [1] was developed to guide and build expert consensus around how emerging data from the pilot evaluations would be used to inform WHO policy recommendations. The Framework established a hierarchy of MVIP objectives, with safety being of highest importance, followed by impact, and lastly feasibility. The Framework outlined a stepwise policy process that would support a recommendation for use as soon as vaccine safety was established and there was evidence of a trend in reducing severe malaria or mortality. Early evaluation of these milestones would enable planning for scale-up by the manufacturer, accelerate financing and procurement of the vaccine and minimize the delay in the introduction of a potentially life-saving vaccine to children at risk. The evaluation would continue beyond any initial recommendation, which would be based primarily on data from the first 3 of 4 vaccine doses, to measure impact definitively and assess the added value of the fourth vaccine dose. Any required modification to the initial recommendations could be made dependent on the final results. By following this stepwise process, the Framework succeeded in assuring safety while enabling faster vaccine introduction for children at risk—at least 2 years earlier than would have been the case had a policy recommendation been delayed until the completion of the MVIP. The Framework and its approach serve as a model for future decision-making around potentially impactful health interventions when outstanding public health questions require further evaluation prior to a broad recommendation for use.