WHO Working Group meeting on standardization of acellular pertussis vaccines: Potency assay Beijing, China, 7-9 November 2007.

New acellular pertussis vaccines have recently been developed in China and India. In this context, potency testing and potential improvements of the protective animal models with inclusion of a reference material were recognized as critical issues in the quality assessment of acellular pertussis vaccines. One of these models, namely Modified Intracerebral Challenge Assay (MICA), is currently used as a potency assay in Japan, China and Korea. A collaborative study comparing whole cell references, a candidate acellular pertussis vaccine reference (JNIH-3) and various acellular pertussis products was undertaken in 2006. The results of the collaborative study showed that MICA worked reliably and gave consistent results between laboratories. JNIH-3 was found to give similar dose-response lines to a variety of acellular pertussis vaccines and DTaP formulations, irrespective of the differences in acellular pertussis components. The WHO Working Group agreed that proposal for establishing JNIH-3 as the First International Standard for acellular pertussis vaccine in MICA should be submitted to the Expert Committee on Biological Standardization at its meeting in October 2008.