Wang G J, Shao M L
The School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China Instrument and Equipment Management Center, National Institute for Food and Drug Control,Beijing 102629, China.
The School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China China Society for Drug Regulation, Beijing 100082, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2022 Jun 6;56(6):878-883. doi: 10.3760/cma.j.cn112150-20220118-00065.
Vaccines for immunization programs play a pivotal role in the prevention and control of infectious diseases in China. Since the implementation of the Expanded Program on Immunization in 2007, a total of 15 vaccines have been used in the national immunization program, which can prevent 15 kinds of diseases. The development of vaccines in China's immunization program in the past decade is analyzed in terms of variety, quantity, production enterprise, quality standard, and supervision system. The results show that the average dose of vaccines for China's immunization planning is about 570 million doses per year from 2011 to 2020. The overall development of the vaccine industry for immunization planning is stable, and there are between one to five manufacturers for each type of vaccine mainly relying on domestic production. Vaccine quality standards have been continuously improved and are basically consistent with international standards. The vaccine supervision system has been continuously completed and covered the entire process of research and development, production and distribution.
用于免疫规划的疫苗在中国传染病防控中发挥着关键作用。自2007年实施扩大国家免疫规划以来,国家免疫规划共使用了15种疫苗,可预防15种疾病。从品种、数量、生产企业、质量标准和监管体系等方面对中国过去十年免疫规划疫苗的发展情况进行了分析。结果显示,2011年至2020年中国免疫规划疫苗年均接种量约为5.7亿剂次。免疫规划疫苗行业整体发展稳定,每种疫苗有1至5家生产企业,主要依靠国内生产。疫苗质量标准不断提高,基本与国际标准接轨。疫苗监管体系不断完善,覆盖了研发、生产和流通全过程。