Background
Approximately 700 million vaccine doses are produced annually in China, making China one of the world’s largest producers of vaccines [
1,
2]. China’s National Regulatory system for vaccines passed assessments by the World Health Organization (WHO) in 2011 and 2014, indicating that China’s vaccine regulatory oversight meets WHO/international standards [
1]. Vaccines are made available through the government’s Expanded Program on Immunization (EPI) at no charge for all children up to 14 years of age [
3]. These government-purchased vaccines are called Category 1 vaccines under the Regulations on the Administration of Vaccine and Vaccination. In contrast, private-sector (Category 2) vaccines, such as Haemophilus influenzae type b vaccine (Hib), rabies vaccine, and influenza vaccine (InfV), are available in China, but are usually paid for out-of-pocket, as they are included in neither the EPI system nor government health insurance.
China’s vaccine industry and immunization program have some differences compared with other countries’ industries and programs, but an overview of the Chinese vaccine industry and immunization effort has not been published in the international scientific literature. In order to allow international peers know better about the development of Chinese vaccine industry and immunization program and share experience, we analyzed selected aspects of vaccines and immunization in China and report the history, immunization policies, classification, supply, and price of vaccines in comparison with selected high- and middle-income countries.
Discussion
Despite significant achievements in vaccine development and production, and the attainment of important goals for polio eradication, hepatitis B control, and tetanus elimination in the past two decades, China’s EPI system protects children from fewer diseases than many high-income and middle-income countries. Notable is the lack Hib, ORV, PCV, influenza and HPV vaccines in China’s EPI system - vaccines that are recommended by WHO for all countries’ national immunization programs but are available only as private-sector vaccines in China.
China’s immunization program has made very good use of the EPI vaccines. Polio was eradicated by 2000; [
19] the prevalence of chronic hepatitis B infection has been reduced by 97% among young children compared with the pre-vaccine era; [
17] the annual incidence of measles has been reduced by more than 99% [
18]. Strategic use of effective vaccines made these achievements possible, despite the challenges of a large population and a vast territory with many densely-populated areas. There are several experiences that could be helpful in low-income countries: 1) China has a large domestic manufacturing base capable of producing large quantity of vaccines at low prices, which has enabled all eligible children to be vaccinated free of charge; 2) the Chinese government has encouraged through policy development expansion of the number of diseases preventable by vaccines; and 3) stringent requirements ensuring access to vaccines through thousands of CDCs and over 200,000 vaccination clinics have ensured high coverage of EPI vaccines. We believe that China’s immunization program experience can help other countries achieve similar results with effective, inexpensive vaccines.
In industrialized countries like the US and the UK, almost all vaccines are regarded as “public goods,” ensuring their availability for all children [
20,
21]. However, some vaccines that WHO recommends for all national immunization programs are Category 2 vaccines in China, which require out-of-pocket payment by parents or persons vaccinated. Category 2 vaccines are associated with lower coverage levels and with coverage that varies by wealth of province. For example, coverage with ORV is 23.7%, and coverage with Hib vaccine is 45.3%. China ranks 7th highest in the world for VPD burden, indicating that more complete implementation of underutilized vaccines can contribute to a healthier childhood population [
22].
The fluctuation of vaccine supply in 2007–2015 shows that the vaccine demand depends on the birth cohort and the government-oriented catch up campaigns. In 2015, the amendment of “Population and Family Planning Law of” was changed China’s one-child policy to a two-child policy. This change will lead to an increase in the birth cohort size and to an increase in vaccine demand.
The prices of China’s Category 1 vaccines were much lower than high-income country and some UNICEF vaccine prices. Low vaccine prices may provide manufacturers with less incentive to invest in production improvements and new vaccine development, which may be a partial explanation for the lack of domestic production of large combination vaccines. From a short- to medium-term public health perspective, lower-cost vaccines are preferable because more children can be vaccinated for a given budget [
23]. Low pricing can be achieved in part through large demands in an economy of scale [
24]. Prices for Category 2 vaccines may be high because their demand volumes are not large enough to achieve an economy of scale. Manufacturers of Category 2 vaccines profit from high prices, which provides an incentive to stay in the market and fund innovations in research and development of novel vaccines. Finding a balance between manufacturers’ profit needs and public health’s needs is challenging. The 2-category system in China is one approach to finding a balance, with traditional vaccines in the program and newer vaccines available in China, but not provided by the program.
Our study has limitations and strengths. Limitations include (1) that procurement prices can vary by province, and we were not able to capture that variation in the study, and (2) that CFDA lot-release program data were not available prior to 2007 [
1]. A strength is that we used official government-reported vaccine licensure information, dose amounts, and pricing. For example, CFDA’s lot-release program was the source of information on the number of doses available in China, and government procurement offices were the source for price information.
Conclusions
We believe that our study supports two recommendations. First, China’s government should induce domestic manufacturers to develop and license vaccines recommended by WHO for inclusion in all national immunization programs. Lack of domestic manufacturers for vaccines such as PCV and HPV vaccine delay introduction into the EPI system. Second, Chinese vaccine manufacturers should be encouraged to participate in the WHO vaccine prequalification program. Vaccines such as bivalent OPV, Sabin IPV, MR, HepE, and EV71 can contribute to the WHO prequalification program and help prevent VPDs in other countries.
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