WHO prequalification of immunization devices:

• Improves the outcomes of national immunization programmes: WHO Member States have been able to reach more people with quality, life-saving vaccines because immunization programme managers can plan, select and procure appropriate products. WHO prequalified products all meet rigorous performance, quality and safety standards that ensure they are fit-for-purpose in challenging operating environments.
• Raises the standard of design, development and production of immunization products, as well as the relevant norms for product testing and prequalification: In the case of new product categories for which standards did not yet exist — such as solar direct drive devices — industry stakeholders and technical partners collaborated to develop appropriate design criteria.
• Drives innovation for immunization devices that better meet challenges found in low-resources settings. Through feedback provided by end users on product life-cycle performance and on the evolving requirements of their operating environments, WHO has been able to inform the performance characteristics of future product features to better meet these needs.
• Increases the value-for-money of immunization devices. Monitoring product performance in operating environments and rigorously testing new products generates insights that help reduce maintenance and running costs of products. This helps to reduce vaccine damage and wastage that can result from equipment failures.
• Facilitates the safeguarding and introduction of a growing range of new and more expensive vaccines which further accelerate achievement of the vaccine coverage goals of the WHO Expanded Programme on Immunization.
• Builds the capacity and availability of product testing laboratories to verify product compliance with the relevant evaluation protocols, using stringent examination, testing and quality assurance methods.
• Improves manufacturers' capacity to develop and test quality products through product field-testing requirements and associated protocols.

WHO prequalification of immunization devices both ensures and increases the availability of quality, reliable products that help safeguard vaccine potency and other immunization supplies. This means it both contributes to the broad access agenda of EPI and supports the WHO's disease elimination and eradication efforts, as well as countries' preparedness and resilience for health emergencies.