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Guidelines on clinical evaluation of vaccines: regulatory expectations

This document provides guidance for national regulatory authorities and vaccine manufacturers on the clinical evaluation of vaccines by outlining the international regulatory expectations applicable to the different stages of vaccine development and for marketing approval. For this reason, the guidance in this document could also be useful for clinicalresearchers and investigators. The text is presented in the form of guidelines rather than recommendations because vaccines are a heterogeneous class of agents, and the preclinical and clinical testing programmes will need to be adapted for each individual product. Guidelines allow greater flexibility than recommendations with respect to specific issues related to particular vaccines. A separate WHO document intended to provide more detailed guidance on preclinical and laboratory evaluation of vaccines is in preparation. This was subsequently established by the 54th meeting, November 2003, of the WHO Expert Committee or Biological Standardization and is to be published in the WHO Technical Report Series. The section of this document that discusses preclinical and laboratory evaluation consequently provides general guidance, but does not define international regulatory expectations in this area.


This document provides guidance to national regulatory authorities(NRAs), manufacturers, clinical researchers and investigators on the clinical evaluation of vaccines by outlining the data that should be obtained during the different stages of vaccine development to support an application for marketing approval. This document has been prepared in response to requests from NRAs for assistance in the evaluation of clinical trials, both during the clinical development of a new vaccine and during the regulatory review of dossiers submitted in support of applications for marketing authorization. The NRAsECB text 36 19/11/2004, 09:48 AMBlack37Gshould have a mandate to review protocols, and when this is necessary to protect the safety of subjects, to require revision of the protocol and/or termination of the trial. This document is intended to provide basic guidance to NRAs on how to achieve these objectives. Because it is common practice for the clinical development programmes and the individual clinical trials to take place in different countries, each NRA should, as far as possible, collaborate with the other regulatory authorities involved to benefit from shared experiences and to align regulatory considerations (1)...

For more information, please refer to: http://www.who.int/biologicals/publications/trs/areas/vaccines/clinical_evaluation/035-101.pdf