Contents and Structure of a WHOPAR

A WHO Public Assessment Report (WHOPAR) for a WHO-prequalified vaccine is a concise document, highlighting the attributes of the vaccine that has been prequalified and providing a summary of the key information upon which the decision to prequalify the product was based. WHOPARs are therefore key documents for UN agencies regarding the acceptability of the vaccine for international supply.

WHOPARs are publicly available and not only for a specialized or scientific community. They aim to present technical information regarding prequalified vaccines that can be readily understood. They are therefore laid out in a Q&A format. Information is also provide as to whether the prequalified vaccine is already licensed or approved for use in the producing/licensing country, or, if intended for export only, brief reasons as to why this is so.

Preparation of a WHOPAR

The WHO staff who were responsible for the evaluation of the clinical and quality information of the product in question prepare a first draft of the WHOPAR. This is shared with manufacturer for review and comments.