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.
Knezevic
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Department of Immunization, Vaccines and Biologicals, Quality, Safety and Standards Team, World Health Organization, Avenue Appia, Geneva, Switzerland.
Baca-Estrada
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Xing
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Lei
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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