58th report: WHO TRS N°963: 2007

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 8 to 12 October 2007. The meeting was opened on behalf of the Director-General by Dr Jean-Marie Okwo-bele, Director, Immunization, Vaccines and Biologicals Department (IVB) Family and Community Health Cluster (FCH).

The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains WHO recommendations and guidelines on Japanese encephalitis vaccine (inactivated), human; regulatory preparedness for human pandemic influenza vaccines; and clinical evaluation of meningococcal C conjugate vaccines. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.