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.
Vaccine. 2012 Nov 26;30(50):7174-8. doi: 10.1016/j.vaccine.2012.10.009. Epub 2012 Oct 19.
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.
在中国，全细胞百日咳（Pw）疫苗于 20 世纪 60 年代初生产，无细胞百日咳（Pa）疫苗于 1995 年引入。现在，百白破联合疫苗已几乎完全取代全细胞百日咳疫苗在国家免疫规划中。为加强中国疫苗的监管，2001 年建立了疫苗批签发制度，自 2006 年以来，无细胞百白破联合疫苗已纳入该制度。本文主要描述了 Pa 疫苗的生产现状和现行的质量控制措施，并分析了 2006 年至 2010 年期间积累的质量控制测试数据。
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