title: Acellular pertussis vaccines in China.
abstract: In China, whole-cell pertussis (Pw) vaccines were produced in the early 1960s and acellular pertussis (Pa) vaccines were introduced in 1995. Pa vaccines have now almost completely replaced Pw vaccines in the national immunization program. To strengthen the regulation of vaccines used in China, a vaccine lot release system was established in 2001 and Pa vaccines have been included in the system since 2006. This paper mainly described the current status of production and the quality control measures in place for Pa vaccines; and analyses quality control test data accumulated between 2006 and 2010.
authors.affiliation: Serum Division, National Institutes for Food and Drug Control, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Bejing 10050, China.
authors.forename: Lichan
authors.initials: L
authors.lastname: Wang
authors.forename: Dianliang
authors.initials: D
authors.lastname: Lei
authors.forename: Shumin
authors.initials: S
authors.lastname: Zhang
mesh_terms: D002681:China / Q000453:epidemiology; D006291:Health Policy; D010567:Pertussis Vaccine / Q000008:administration & dosage* / Q000276:immunology* / Q000592:standards; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D022282:Vaccines, Acellular / Q000008:administration & dosage / Q000276:immunology / Q000592:standards; D014917:Whooping Cough / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D010567:Pertussis Vaccine; D022282:Vaccines, Acellular