Immunization standards

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.

Following consultation with Industry and Programmatic representatives, and endorsement by the Immunization Practices Advisory Committee (IPAC) the guidance document on Assessing the Programmatic Suitability of vaccine Candidates for WHO Prequalification has been published.

Revised documents are available for comments until 26 May 2014

We would welcome written comments on these two documents, by email to, by 26 May 2014.


Last update:

18 May 2014 16:04 CEST