Thiomersal in vaccines: a regulatory perspective

Overview

A consultation, organized by the WHO Quality Assurance and Safety of Biologicals 3 Team, was therefore held in Geneva, 15-16 April 2002, to review experiences with the removal of thiomersal from vaccines and to discuss related regulatory implications. It was attended by representatives from National Regulatory Authorities (NRAs) and the vaccine industry (list of participants in Annex) and chaired by Dr Franz Reigel (Switzerland); Dr Roland Dobbelaer (Belgium) served as a rapporteur. The meeting was not an isolated event, but part of a co-ordinated programme of work on the issue of thiomersal undertaken by the whole WHO Department of Vaccines and Biologicals.

The objective of the Consultation was to review, in a global forum, the experience of eliminating, reducing and/ or replacing thiomersal in vaccines and to discuss the potential impact of these changes on the quality, safety and efficacy of vaccines. The review involved NRAs and vaccine manufacturers from developing and industrialized countries and the focus was on vaccines already licensed with thiomersal.