Vaccine evaluation for WHO prequalificationincorporates:
- review of general, administrative and specific information that is relevant to the vaccine and the global supply, including programmatic issues and stability data to support the use of vaccine vial monitors
- verification that the safety and efficacy data that support the claims of the manufacturer
- review of general production process and quality control procedures,
- testing of the consistency of vaccine lots
- WHO site inspection to manufacturing facilities with observers from the responsible national regulatory authority.
Upon completion of these phases, WHO prepares a report of the outcomes of the assessment and inspection(s) and sends it to the manufacturer. The responsible NRA is also copied. In the case of a satisfactory outcome the WHO will grant the product prequalified status.
When applying the streamlined-procedure, WHO relies on the oversight of the responsible NRA, when that authority is considered to be stringent. In such cases, WHO may decide, on a product-by-product basis, to rely on one or more of the following:
- the NRA assessment reports
- review of NRA/national control laboratory testing results, if applicable (rather than independent testing carried out by WHO)
- review of the NRA inspection reports which WHO may decide to supplement with a short audit (instead of a full site inspection), focused on aspects related to UN tender specifications.
WHO also has an emergency use assessment and listing procedure. This can be applied during public health emergencies of international concern, for example. It is not a WHO prequalification procedure but a procedure aimed at making urgently-needed but as yet unlicensed products available for a limited period. EUL assessment is based on a predetermined, minimal amount of product quality, safety and efficacy information, while further data continue to be gathered and evaluated. In other words, EUL is a risk-based procedure.