Vaccines intended for use in low-and middle-income countries (LMICs) will benefit from a policy recommendation from WHO’s Strategic Advisory Group of Experts on immunizations (SAGE).  However, no formal mechanisms or systematic approaches currently exist to inform vaccine developers of the evidence anticipated to facilitate global policy recommendations, before a vaccine candidate approaches regulatory approval at the end of pre-licensure efficacy studies. Consequently, significant delays may result in vaccine introduction and uptake, while post-licensure data are generated to support a definitive policy decision. 

New WHO guidance on Evidence Considerations for Vaccine Policy (ECVP) aims to mitigate introduction delays post-licensure by providing early information on data and evidence that is anticipated to be needed to support country-level, regional and WHO global policy making for new vaccines in priority disease areas. The ECVP builds upon and expands WHO Preferred Product Characteristics (PPC) guidance that identifies preferential product attributes, particularly for vaccines to be used in LMICs, that is typically developed early in clinical development.  The ECVP facilitates early engagement and alignment across the stakeholders involved in vaccine development and those responsible for vaccine regulatory, policy, funding and country introduction decisions. This framework aims to anticipate and collectively delineate the clinical, observational and other data likely to be required by global and national policymakers, and to do so when most valuable – during development of the late-stage clinical plan, including the design of the pivotal licensure trial.

The generic ECVP framework and the first ECVP for Tuberculosis Vaccines Intended for Adults and Adolescents was developed with the close collaboration of the ECVP expert advisory group and the final ECVP for TB Vaccines is published here. More information on the principles of the ECVP and the current  version of the generic ECVP framework can be found here: WHO Evidence Considerations for Vaccine Policy Development (ECVP). This generic ECVP framework may be adapted to develop ECVP for specific vaccines in the pipeline.

 More information on the principles of the ECVP and the current  version of the generic ECVP framework can be found here: WHO Evidence Considerations for Vaccine Policy Development (ECVP). This generic ECVP framework may be adapted to develop ECVP for specific vaccines in the pipeline.