WHO prequalification of immunization devices fulfils a number of key roles. It:
- sets and enforces quality and performance standards that reflect product end user needs
- helps shape technology to meet evolving user requirements
- provides assurance to national and international procurers that products adhere to the desired standards of quality and safety and meet the relevant performance requirements of low-resource settings.
WHO's thorough evaluation process also helps manufacturers to improve their capacity to meet quality standards, be these for existing products or needed new technologies. Rigorous laboratory testing protocols are established for all products proposed for prequalification; this helps to build testing laboratories’ capacity to stringently verify that products meet the required standards.
WHO ensures the availability of quality, reliable products that help safeguard vaccine potency, as well as increase their availability, thereby contributing to the broad access agenda of the WHO Expanded Programme on Immunization and supporting the Organization’s mission to build a better, healthier future for people everywhere.
WHO also works to stimulate innovation in immunization technologies to better meet challenges found in low-resources settings and to help safeguard a growing range of new and more expensive vaccines.
- Improve the outcomes of national immunization programmes: WHO Member States have been able to reach more people with quality, life-saving vaccines because immunization programme maagers 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.
- Raise 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 have collaborated to develop appropriate design criteria.
- Drive innovation for immunization devices. 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 design of future product features.
- Increase value-for-money of immunization devices. Monitoring product performance in operating environments and rigorously testing new products has generated insights that have contributed to lower maintenance and running costs of products. This has helped to reduce vaccine damage and wastage that can result from equipment failures.
- Facilitate 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 EPI.
- Build 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.
- Improve manufacturers’ capacity to develop and test quality products through product field-testing requirements and associated protocols.