WHO Working Group meetings on revision of the Manual laboratory methods for testing DTP vaccines

Overview

The meeting on 20-21 July 2006 was opened by Dr D. J. Wood, Coordinator of Quality, Safety and Standards (QSS) of the Immunization, Vaccines and Biologicals Department (IVB), WHO. Professor R. Dobbelaer was appointed Chairman and Dr M. J. Corbel as Rapporteur. Dr Wood stated that the objectives of the meeting were to review the methods currently available for determining the potency of diphtheria, tetanus and pertussis (wP) vaccines and to appoint a drafting group to revise the manual. He then described the current organization of the QSS group and its interaction with other sections of WHO, particularly those concerned with immunization, vaccines and biologicals. The DTP Manual needed to be seen in the context of developments in the immunization world. An average global coverage of 78% was reported for DTP immunization. Coverage with full immunization for >90% of the population was achieved in 106 countries, with 80-89% coverage in a further 32 countries and 50-79 % in 42 countries, with <50% coverage in 12 countries, mainly in Africa. There was room for improvement and introduction of new vaccines for a wider range of diseases could prevent many more deaths. The Global Immunization Vision and Strategy (GIVS) initiative from WHO and UNICEF was designed to achieve this over the next 10 years. This required an integrated strategy involving the IVR unit, QSS and the EPI team.

Following the first meeting in July 2006, separate drafting groups provided the first drafts based on the basic principles agreed on that occasion. The working group again met in Geneva on 28-30 March 2007 to review the drafts and to input further suggestions or amendments to the contributions of the drafting groups. The second meeting was opened by Dr I. Knezevic (WHO, QSS). Dr J. G. Kreeftenberg (Netherlands Vaccine Institute, Holland) was appointed Chairman and Dr Y. Horiuchi (NIID, Japan) was appointed Rapporteur. Dr Knezevic summarized the background and role of WHO in providing and promoting the implementation of norms and standards, especially in the dynamic field of vaccine development. The complexity of current formulations of DTP vaccines, and the need for continuing regulatory research were emphasized. She overviewed current global developments in biological standardization, stressed the importance of medicinal products of good quality for public health and clarified the role and responsibility of WHO in biological standardization, which is essential for assessing quality of vaccines and biologicals.