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.
Department of Immunization, Vaccines and Biologicals, Quality, Safety and Standards Team, World Health Organization, Avenue Appia, Geneva, Switzerland.
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D001681:Biological Assay; D002681:China; D004306:Dose-Response Relationship, Immunologic; D017408:Guidelines as Topic; D006801:Humans; D010567:Pertussis Vaccine / Q000737:chemistry / Q000276:immunology / Q000592:standards*; D011786:Quality Control; D012015:Reference Standards; D022282:Vaccines, Acellular / Q000737:chemistry / Q000276:immunology / Q000592:standards; D014917:Whooping Cough / Q000276:immunology* / Q000517:prevention & control*; D014944:World Health Organization
D010567:Pertussis Vaccine; D022282:Vaccines, Acellular