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.
- Assessing the Programmatic Suitability of Vaccine Candidates for WHO Prequalification, WHO/IVB/12.10
Revised documents are available for comments until 26 May 2014
We would welcome written comments on these two documents, by email to email@example.com, by 26 May 2014.