WHO vaccines prequalification is a service provided to UNICEF and other UN agencies that procure vaccines.
The goal of WHO vaccines prequalification is to ensure that vaccines used in immunization programmes are safe and effective. Prequalification also supports the specific needs of national immunization programmes with regards to vaccine characteristic such as potency, thermostability, presentation, labelling and shipping conditions. As a result, more people can be vaccinated with safe, effective and quality vaccines because immunization programme managers can plan, select and procure appropriate products.
In prequalifying vaccines, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe and effective. WHO also ensures the continued safety and efficacy of prequalified vaccines through regular re-evaluation, site inspection, targeted testing and investigation of any product complaints or adverse events following immunization.
National regulatory agencies (NRAs) and national control laboratories (NCLs) play a vital role in WHO vaccines prequalification since they are responsible for regulatory oversight, testing and release of WHO-prequalified vaccines.
WHO vaccines prequalification contributes to innovation when there is a compelling unmet public health need for new products. This is achieved by supporting vaccine innovation and by providing technical support to vaccine manufacturers in collaboration with other organizations and networks. Demand forecasting is also supported: WHO vaccines prequalification, in partnership with UNICEF and Gavi, makes a significant contribution to the creation and maintenance of a healthy market for vaccines.