Assessing the programmatic suitability of vaccines candidates for WHO prequalification
As part of the WHO vaccine prequalification process, product summary files are assessed by the WHO PQ Secretariat to determine ‘the suitability of the vaccine for the immunization services where it is intended to be used’.
The emergence of unique vaccine presentations has driven the need to define the characteristics that determine programmatic suitability and to formally structure the process for assessing compliance with these characteristics.
A Working Group was formed and charged with drafting a White Paper with the purpose of providing transparency and objectivity to this process, and guidance to vaccine industry.
The first draft of this document was presented at the Strategic Advisory Group of Experts (SAGE) meeting held in April 2010 and in the Informal consultation of the ad hoc committee on vaccines prequalification held in May 2010 in Geneva.
Several draft versions have been circulated and comments from vaccine industry and programmatic experts were discussed at different Immunization Practices Advisory Committee (IPAC) meetings held in 2010 and 2011.
IPAC in its meeting held from 28 to 29 September 2011 endorsed the document for publication.
The latest draft version is posted.