Points to consider for manufacturers of human vaccines: clinical considerations for evaluation of vaccines for prequalification
This document aims at providing additional guidance to manufacturers who intend to submit vaccines for prequalification. It was prepared in close consultation with a group of experts who met in Chiang Mai, Thailand, from 15 to 19 February 2010, preliminary versions had limited circulation for comments among the meeting participants, WHO staff, the Developing Country Vaccine Manufacturers Network (DCVMN) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and at a later stage it was available for public comment until 15 September 2010. The current ("final") version was prepared taking into consideration comments received through that virtual consultation. Most of the comments received were actually requests for clarification of the applicability of the guidance to specific products, and the others that were not incorporated into the document expressed minor rather than major differences with the adopted version.
Two important aspects of this "points to consider" document are: 1) whenever necessary it can be revised to further clarify points that might have remained obscure, or to include issues not addressed in it; 2) although the manufacturers are expected to follow its guidance, they are free to discuss its applicability to individual products, in which case the WHO Prequalification Secretariat should be consulted sooner rather than later.