- West Africa Medicines Regulation Harmonization Initiative

Author: WAHO

Category: Medical Product Dossier Evaluation and Registration

Language: English

Description These Guidelines have been adopted by WAHO from the WHO Guidelines on clinical evaluation of vaccines: regulatory expectations. These WHO Guidelines are intended to replace the WHO Guidelines on clinical evaluation of vaccines: regulatory expectations, which were adopted by the Expert Committee on Biological Standardization in 2001 (1). The document of 2001 provided guidance on the clinical evaluation of vaccines as well as on WHO vaccine prequalification. Since 2001, more than 20 vaccine-specific documents (each including a section on clinical evaluation) have been adopted by the Committee. Originally intended to be read in conjunction with the 2001 document, these documents provide guidance on both oral and inactivated polio vaccines, whole cell pertussis and acellular pertussis vaccines, meningococcal conjugate vaccines for serotypes A and C, and pneumococcal conjugate vaccines, as well as on vaccines intended to prevent diseases caused by rotaviruses, dengue viruses, human papillomaviruses (HPVs) and malaria parasites. These revised WHO Guidelines have been prepared to reflect the scientific and regulatory experience that has been gained from vaccine clinical development programmes since the adoption of the 2001 version. They are intended for use by companies planning to make submissions to WAHO for vaccine registration. The document takes into account the content of clinical development programmes, clinical trial designs, the interpretation of trial results and post-licensing activities.

Abstract These Guidelines consider clinical development programmes for vaccines that are intended to prevent clinical disease in humans by eliciting protective immune responses. The protective immune response to vaccination may be directed against one or more specific antigenic components of microorganisms or against substances produced and secreted by them (for example, toxins) that are responsible for clinical disease. The clinical disease prevented by vaccination may be an acute infectious disease and/or a disease that results from chronic infection with an infectious agent. These Guidelines are applicable to the clinical development of: ■ new candidate vaccines; ■ licensed vaccines; ■ vaccines that are given by any route of administration; ■ vaccines that may be given before exposure or shortly after known or presumed exposure to an infectious agent to prevent the onset of clinical disease.

Essential Medicines & Vaccines

WAHO Guideline on Clinical Evaluation of Vaccines