WHO Information Consultation on Acellular Pertussis, DTwP, Hepatitis B and Combination Vaccines:  meeting report on acellular pertussis vaccine sessions

Overview

This report reflects the discussion and conclusions of a WHO group of experts from National Regulatory Authorities, National Control Laboratories, vaccine industries and other relevant institutions, meeting on 9-13 November 2009, in Geneva, Switzerland for the revision of WHO Guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines. Based on the recent developments and standardization in quality control methods and manufacturing process the revision of these WHO Guidelines has been initiated and the drafting group has revised the document. In the meeting the current situation of quality control methods in terms of potency and safety, and nonclinical and clinical evaluation of acellular pertussis vaccines were presented and discussed. The revised Guidelines were reviewed and recommendations on further revision to reflect the current development and ensure the quality, safety and efficacy of the vaccine were made by the participants to guide the next steps of the revision by drafting group. The revised Guidelines will be finalized and submitted to the Experts Committee on Biological Standardization of WHO for final adoption.