The landscape of vaccines in China: history, classification, supply, and price

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.

Keywords: China; Classification; History; Price; Supply; Vaccine.

Fig. 1

Timeline of initial vaccine licensure and inclusion in the immunization program since the 1930s. The yellow frames showed the NIP and EPI events, the orange frames showed the year of WHO prequalification. Underlined vaccines are imported vaccines

Fig. 2

EPI and private-sector vaccination schedule from birth to 7 years old in China. EPI vaccines are shown in green. Vaccines shown in gold are private-sector vaccines that are recommended by WHO for inclusion in all national programs

Fig. 3

Vaccine Preventable Diseases (VPDs) for national immunization program vaccines in China, US, UK, Russia, Brazil, India and South Africa. VPDs indicated with green are EPI vaccines in the respective countries. Gold indicates diseases prevented by national programs in the UK, US, Russia, or Brazil’s NIP but whose vaccines are not included in China’s EPI system. Light blue indicates that the VPDs for which there is no licensed vaccines in China

Fig. 4

Supply volumes of domestic and international Category 1 (EPI) and 2 (private sector) vaccines from 2007 to 2015. The fluctuation of supply of Category 1 vaccines was largely due to vaccination campaigns. The supply of H1N1 reached 70 million doses in 2010. The supply of HepB and MV increased by 83% and 202% in 2010 for supplementary immunization activities

Fig. 5

Comparison of prices of vaccines among China, US, European countries and UNICEF (The exchange rate for US dollars - Chinese Yuan was 6.2)