Abstract
BACKGROUND: Vaccine regulation in China meets World Health Organization standards, but China's vaccine industry and immunization program have some characteristics that differ from other countries. We described the history, classification, supply and prices of vaccines available and used in China, compared with high-and middle-incomes countries to illustrate the development of Chinese vaccine industry and immunization program. METHODS: Immunization policy documents were obtained from the State Council and the National Health and Family Planning Commission (NHFPC). Numbers of doses of vaccines released in China were obtained from the Biologicals Lot Release Program of the National Institutes for Food and Drug Control (NIFDC). Vaccine prices were obtained from Chinese Central Government Procurement (CCGP). International data were collected from US CDC, Public Health England, European CDC, WHO, and UNICEF. RESULTS: Between 2007 and 2015, the annual supply of vaccines in China ranged between 666 million and 1,190 million doses, with most doses produced domestically. The government's Expanded Program on Immunization (EPI) prevents 12 vaccine preventable diseases (VPD) through routine immunization. China produces vaccines that are in common use globally; however, the number of routinely-prevented diseases is fewer than in high- and middle-income countries. Contract prices for program (EPI) vaccines ranged from 0.1 to 5.7 US dollars per dose - similar to UNICEF prices. Contract prices for private-market vaccines ranged from 2.4 to 102.9 US dollars per dose - often higher than prices for comparable US, European, and UNICEF vaccines. CONCLUSION: China is a well-regulated producer of vaccines, but some vaccines that are important globally are not included in China's EPI system in China. Sustained and coordinated effort will be required to bring Chinese vaccine industry and EPI into an era of global leadership.