Developing an effective and sustainable national immunisation programme in China: issues and challenges

Summary

Since its establishment in 1978, China's National Immunization Program has made remarkable achievements in the control of vaccine-preventable diseases. The National Immunization Program is a vertically integrated programme in the health system, which delivers immunisation services to children. However, achieving the ambitious goals of the Immunization Agenda 2030 and Healthy China 2030 will require overcoming challenges to the National Immunization Program's future expansion and development. Key challenges include inclusion of all WHO-recommended vaccines into the routine programme, improving the function and support of the National Immunization Advisory Committee, increasing and sustaining reliable vaccination financing, ensuring uninterrupted vaccine supplies, overcoming regional disparities in immunisation practices and cold chain processes, strengthening the workforce, and integrating immunisation information systems into all aspects of the programme. It is crucially important to strengthen the National Immunization Program to attain universal coverage of life-saving vaccines in China and meet the 2030 goals.

Introduction

China's National Immunization Program has made remarkable progress in reducing vaccine-preventable diseases over the past four decades. In 1974, WHO launched the Expanded Program on Immunization to tackle vaccine-preventable diseases and ensure that children from all countries could benefit from life-saving vaccines.^{1, 2} WHO called on Member States to establish national immunisation programmes that included a minimum set of recommended vaccines. In response, the Ministry of Health of China (now the National Health Commission) established the planned immunisation programme in 1978.³ Four vaccines—BCG; oral polio vaccine; diphtheria, tetanus, and pertussis vaccine (DTaP); and measles vaccine—were included into the programme to prevent the six WHO-recognised vaccine-preventable diseases. The programme was recognised and renamed as the National Immunization Program in 2002, and between 2002 and 2008, the set of National Immunization Program vaccines was expanded to stop 15 vaccine-preventable diseases.^{3, 4} Universal childhood immunisation with these four vaccines was achieved when vaccination coverage among children aged 1 year reached or exceeded 85% at provincial level by 1988 and county level by 1990.⁵ Coverage of routinely recommended vaccines in China's birth cohort of 16 million has been over 95% for many years.⁴

To achieve the UN's health-related Sustainable Development Goals (SDGs) and attain the largest health benefit from vaccines, WHO and partner organisations developed the Immunization Agenda 2030 with an ambitious global vision and strategy for vaccines and immunisation from 2021 to 2030. The Immunization Agenda 2030 was the successor to the WHO Global Vaccine Action Plan, 2011–2020.⁶ The Immunization Agenda 2030 aims to achieve universal coverage of life-saving vaccines worldwide by maintaining hard-won gains and further advancement, despite disruptions due to COVID-19. There are seven strategic priorities and ten vaccine-preventable disease control targets in Immunization Agenda 2030.⁶ Immunization Agenda 2030 emphasises building a stronger national immunisation infrastructure that is integrated into a primary health-care service delivery system and calls for strengthening of health systems to ensure effective immunisation programme implementation. However, achieving Immunization Agenda 2030 goals will mean overcoming challenges such as inequitable access to vaccines, vaccine hesitancy, and gaps in workforce capacity and sustainable financing.⁷ The Chinese Government has made a strong commitment to endorsing SDGs. In 2016, the state council issued the Healthy China 2030 Planning Outline (thereafter referred to as Healthy China 2030), with five broad goals and 13 specific targets to improve the health and wellbeing of Chinese people.⁸ Prevention of vaccine-preventable diseases by improving vaccine coverage is a key strategy in Healthy China 2030 for effective control of infectious diseases.⁹

Despite great achievements made over the past four decades, there is room to improve coverage, efficiency, and resilience of the China National Immunization Program. WHO recommends four vaccines for all national immunisation programmes: human papillomavirus (HPV) vaccine, Haemophilus influenzae type b (Hib) vaccine, pneumococcal conjugate vaccine (PCV), and rotavirus vaccine; however, the China National Immunization Program does not include these vaccines, despite producing them domestically.¹⁰ China's National Immunization Program faces well documented challenges to improve efficiency and effectiveness of immunisation services, including ensuring sufficient and stable financing and ensuring a strong and well trained professional workforce.¹¹ Herein, we summarise the achievements of and key challenges facing China's National Immunization Program, and propose actions to achieve universal coverage with all WHO-recommended life-saving vaccines.

Achievements of China's National Immunization program

Decrease of the disease burden of vaccine-preventable diseases

The burden of vaccine-preventable diseases in China has decreased dramatically since the establishment of the National Immunization Program (table). High vaccine coverage is facilitated by strong implementation of the National Immunization Program and important factors, including the hukou and immunisation certificate system, which is the household registration system used in mainland China that grants residency-based access to education, health care, pension, and other social services and benefits.¹² In addition, fast economic development, better nutrition, maternal and child health programmes, a strengthened health system, and advances in medical technique have all contributed to reduce deaths from vaccine-preventable diseases. There is evidence showing that the incidence of 11 monitored vaccine-preventable diseases was 1723 per 100 000 population in 1959, and has decreased markedly since 1978, remaining at low incidence since 1990.⁴ For example, pertussis decreased by 98% from 1978 to 2018, and measles decreased by 99% during the same time.⁴ Annual vaccine-preventable disease mortality peaked at 49·96 per 100 000 population in 1959, with the total number of vaccine-preventable disease deaths exceeding 0·3 million. By 2017, mortality decreased by more than 99% to less than 1 (0·038) per 100 000 population.⁴

Table.

Change in the burden of 11 monitored vaccine-preventable diseases in China from 1950 to 2021

	Notified cases	Notified deaths	Notified incidence rate (per million people)	Notified mortality rate (per million people)
Japanese encephalitis
1950	1345	477	2·4	0·9
2007	4330	227	3·3	0·2
2021	207	6	0·1	0
Meningococcal meningitis
1950	7490	1239	13·6	2·2
2007	1198	124	0·9	0·1
2021	63	5	0	0
Hepatitis A
1950	..	..	..	..
2007	77 135	29	58·4	0
2021	11 979	1	8·5	0
Hepatitis B
1950	..	..	..	..
2002	668 326	780	520·3	0·6
2021	976 233	413	692·5	0·3
Tuberculosis
1950	..	..	..	..
1997	418 234	815	338·3	0·7
2021	639 548	1763	453·7	1·3
Pertussis
1950	19 855	536	36	1·0
1978	1 202 922	1351	1249·7	1·4
2021	9611	2	6·8	0
Diphtheria
1950	15 297	1591	27·7	2·9
1978	20 047	1698	20·8	1·8
2021	0	0	0	0
Mumps
1950	..	..	..	..
2007	252 701	1	191·3	0
2021	119 955	0	85·1	0
Rubella
1950	..	..	..	..
2007	74 746	..	56·6	..
2021	840	0	0·6	0
Measles
1950	132 167	8534	239·5	15·5
1978	2 377 776	9573	2470·2	9·9
2021	552	0	0·4	0
Polio
1950	..	..	..	..
1978	10 353	259	10·8	0·3
2021	0	0	0	0

Data are n unless otherwise specified. Data were collected for 3 specific years, with 1950 as a baseline year when the vaccine was introduced to China's National Immunization Program (expect for tuberculosis, which includes 1997 when the data were first available). The data were collected from the China National Notifiable Infectious Disease Surveillance System, for the purpose of showing the historical change of vaccine-preventable disease burden only.

In 2000, China was declared polio free by WHO¹³ and diphtheria was last reported in 2005.³ A striking fall in hepatitis B virus (HBV) infection among young children has been observed since 1992, when the HBV vaccine was included in the management of the National Immunization Program to prevent perinatal infection with HBV.¹⁴ The seroprevalence of HBV surface antigen, a marker of chronic HBV infection, declined from 10·5% in 1992 to 0·8% among children younger than 15 years and 0·3% among children younger than 5 years by 2014.¹⁵ The incidences of reported pertussis and measles decreased from 125 and 247 per 100 000 population in 1978 to 0·7 and 0 in 2021, respectively (table).

Improvements in National Immunization Program implementation

The National Immunization Program is embedded in China's health system, and focused on providing safe, efficient, and effective immunisation services. Substantial progress has been made in many aspects, including governance, financing, service delivery, workforce, and information system development. Importantly, the Vaccines Administration Law came into effect in December, 2019. As the first comprehensive, vaccine-specific law in the history of China, it provides a legal framework designed to enhance vaccine administration, supply, and quality; promote research, development, and manufacturing of vaccines; and strengthen standards for high-quality service delivery.¹⁶ In particular, to maximise vaccine protection among children, the Vaccines Administration Law requires the ministries of health and education to jointly develop guidelines for checking vaccination records of school children, so that children who are new to a school and in need of one or more doses of vaccine can be referred to their immunisation clinic to receive the required vaccine.¹⁷

Led by the National Health Commission, the National Immunization Program has an intertwined management network paralleling the health system governance structure (figure). Horizontally, health administrative departments (health commissions), technical institutions (China Centers for Disease Control and Prevention [CDCs]), service delivery institutions (vaccine clinics hosted by designated qualified health facilities), and regulators (medical products administrations and former food and drug administration [China FDA]) supervise and manage the implementation of the National Immunization Program. Vertically, these governance units are established at multiple administrative governmental levels depending on institutional function.

Figure.

Organisation structure of China's National Immunization Program

CDC=Center for Disease Control and Prevention. NHC=National Health Commission.

In addition to governance and management structure, there are national-level government workshops that provide evidence-informed recommendations and expert opinions on policies relevant to the National Immunization Program. China's Experts Advisory Committee on Immunization Program was established in 1982, and evolved into the National Immunization Advisory Committee in 2017.^{18, 19} The National Immunization Advisory Committee is under the auspices of the National Health Commission and China CDC supports technical working groups to provide evidence-based support for the National Immunization Advisory Committee. The National Immunization Advisory Committee has two main responsibilities. The first is to comprehensively review, evaluate, and collect evidence on the burden of vaccine-preventable diseases; the safety, efficacy, and cost-effectiveness of vaccines; and the production and supply capacity by vaccine manufacturers. The second is to propose evidence-informed technical recommendations for strengthening the National Immunization Program and optimising effectiveness, safety, and efficiency of routine immunisation, including revising vaccine immunisation schedules, and adjusting and expanding the vaccines included in the National Immunization Program.¹⁹ Currently, the membership of the National Immunization Advisory Committee is only open to experts who are internally selected and appointed by the National Health Commission every 3 years. There are 27 voting members with diverse backgrounds in relevant fields including epidemiology, biostatistics, microbiology, vaccinology, clinical medicine, health policy, economics, and immunisation practices.¹⁹ To fulfil its role, the National Immunization Advisory Committee holds at least one full-day, in-person annual closed meeting to discuss recommendations, and other additional meetings can be organised when required.

The National Immunization Program is financed by the Chinese Government at various administrative levels, and the financing strategy has been evolving since the 1970s. The vaccines in the National Immunization Program are free to all eligible recipients. The central Chinese Government now pays for vaccines for the entire country, and local governments cover administration costs with support from the central government's transfer funding, particularly for low-income provinces. Before 2003, the immunisation service providers were allowed to charge service fees to subsidise their administration costs; however, this charge was banned after the severe acute respiratory syndrome coronavirus epidemic and only covers National Immunization Program vaccines. In 2015, the government funded 70·6% of the total costs, of which the central government contributed the largest proportion, accounting for an average of 39% of total costs.²⁰ The proportion of funding from the central government varies by region, and is highest in low-income western provinces. Non-governmental costs are subsidised by revenue gained from delivering non-National Immunization Program vaccination services.²⁰ Total government investment in the National Immunization Program has increased over the years. An internal survey, conducted in 25 provinces, showed that government expenditure per capita for the National Immunization Program increased from ¥10·66 in 2014 to ¥17·69 in 2018 (¥1 is approximately equal to US$0·16), equivalent to an average annual growth rate of 13·2%. The annual growth rate was highest among western provinces (21·2%), followed by eastern (11·9%), and central provinces (8·6%).

Vaccination clinics hosted by designated qualified health facilities are responsible for immunisation service delivery, as mandated in the Vaccines Administration Law.¹⁶ County CDCs provide technical support to the clinics, having previously managed some clinics before the law came into effect in 2019. Led by the China CDC, a comprehensive cold chain that covers the entire service network has been built that ensures safe transportation and storage of vaccines. Cold chain equipment includes cold storage rooms, refrigerated trucks, cold boxes, medical refrigerators, and temperature control monitors. In addition, wealthy provinces rely on external cold chain delivery services provided by commercial logistics companies to improve distribution efficiency. To avoid any risk of breaching the transportation temperature requirements, the Vaccines Administration Law ensures the quality and safety of vaccine delivery, for all relevant entities including third-party delivery companies.¹⁶

The vaccine and immunisation workforce are aligned with the health system. The total number of personnel working on routine immunisation (not all full time) has been increasing nationwide, rising from 168 000 in 2006 to 236 000 in 2019.²¹ Efforts have been made to enhance the quality of the workforce. The Vaccines Administration Law has fostered a strict qualification management system for institutions and professionals involved in vaccines and immunisation. The law indicates that health personnel who provide immunisation services must pass an examination and be certified as practicing physicians, assistant physicians, nurses, or village doctors, and have received professional training about immunisation organised by county-level health commissions.¹⁶

A nationwide network of comprehensive immunisation information systems has been established. Provincial CDCs started to develop immunisation information systems in 2004 to convert paper-based records to electronic records. Immunisation information systems enable individualised case management of children's vaccinations, and link this to health identifiers monitoring adverse events following immunisation.^{22, 23} Provincial immunisation information systems were greatly improved and strengthened in 2010, with left-over funding from Gavi, the Vaccine Alliance, which supported projects led by the Ministry of Health (now the National Health Commission). The use of electronic health records has substantially increased the efficiency of data collection for real-time management and estimates of vaccine coverage. The coverage of electronic health records had reached 100% at provincial level and 95% at township level by 2021. Current information systems integrate multiple functions, including vaccination coverage monitoring, vaccine management, management of children's vaccinations in accordance with the routine immunisation schedule, school entry vaccination status verification, cold chain management, and reporting and monitoring of adverse events following immunisation.²² Laboratory-supported surveillance of vaccine-preventable diseases is a core part of the National Immunization Program. Laboratory analyses are essential for diagnosis of vaccine-preventable diseases, serological surveillance for population immunity, environmental surveillance for eradicable diseases like polio, and discovery and development of diagnostics for emerging pathogens. The China CDC (with provincial, prefectural, and county CDCs) operate laboratory networks and serve as WHO reference laboratories for polio, measles, rubella, Japanese encephalitis, rotavirus, and influenza.

The official vaccine safety monitoring system is operated by the China CDC and the National Medical Products Administration, formerly the China FDA. Established in 2005 and expanded nationwide in 2008, the China National Adverse Event Following Immunization Surveillance system is a passive vaccine safety system to which providers and others report cases of adverse events following immunisation. Each serious adverse event following immunisation is investigated by local CDCs for causality assessment and to identify whether the adverse events following immunisation were caused by vaccination or was coincidental to vaccination.²³ With National Health Commission support, the China CDC is pilot testing active vaccine safety surveillance that allows associations between vaccination and adverse events to be evaluated quantitatively. Such an enhancement is facilitated by linkage to electronic health records via a common health identifier, demonstrating the value of the National Immunization Program being part of China's health system.²⁴ The electronic health records are managed by community health centres at primary care level, and the information is stored in the local health information system. Only authorised personnel at community health centres, CDCs, and health commissions have access to them. Similar to several other countries, China has a Vaccine Injury Compensation Program that serves as a no-fault insurance programme to compensate families for vaccine-caused injuries to children.²⁵ The Vaccine Injury Compensation Program was established by regulation in 2005, and written into legislation in the Vaccines Administration Law.²⁶ The table of evidence-based vaccine injuries was developed by the China CDC and is kept up to date in terms of advances in the science of vaccine safety.

Challenges of expansion and effective implementation of the National Immunization Program

Despite progress, the National Immunization Program faces challenges of expanding the number of vaccine-preventable diseases prevented by programme vaccines and realising more effective implementation. In 2020, WHO recommended that all national immunisation programmes use vaccines to prevent ten vaccine-preventable diseases,²⁷ but vaccines against four of the ten vaccine-preventable diseases are not included in the National Immunization Program (ie, PCV, HPV, Hib, and rotavirus vaccines) despite inclusion of some of these vaccines (eg, HPV vaccine) in local immunisation programmes in pilot cities. Among the 194 WHO Member States' vaccination programmes, 82·5% have included the PCV vaccine, 66·5% have included HPV vaccine, 99% have included the Hib vaccine, and 59·8% have included the rotavirus vaccine.²⁸

The National Immunization Advisory Committee was established in 2017, and written into the 2019 Vaccines Administration Law, with an express mandate to provide evidence-based recommendations to the National Health Commission for including new vaccines into the National Immunization Program. Although the National Immunization Advisory Committee recommendations helped optimise the routine immunisation schedule, the National Immunization Advisory Committee has not yet recommended inclusion of new vaccines. There is no formal working mechanism for the National Immunization Advisory Committee to update the formulary of National Immunization Program vaccines, making it difficult to standardise and optimise operations. For example, it is unclear how the National Immunization Advisory Committee should cooperate with relevant technical and administrative departments to establish priority vaccines for inclusion in the programme. In addition, the membership of the National Immunization Advisory Committee is only open to internally selected experts, and no consumer voice is heard.

Although government investment in the National Immunization Program has been increasing, financing is limited, with insufficient and unsustainable funding. In 2015, 71% of National Immunization Program working funds came from the government and 29% were from sales and delivery of non-programme vaccines to families.²⁰ The central government provides the largest proportion of funding (39%), followed by county-level (18%), provincial-level (5%), municipal-level (5%), and township-level (4%) governmental contributions. The largest expenses were for personnel (54%) and vaccine purchases (21%).²⁰ Other than COVID-19 vaccines, health insurance plans do not cover vaccines in China, as the Healthcare Security Law stipulates that health insurance cannot support public health programmes or services.²⁹ On average, China invests less than US$100 per child in the National Immunization Program, similar to investment in low-income countries and much lower than in high-income countries, for which investment exceeds hundreds of US dollars per child; indeed, the US investment exceeds US$2000 per child.^{30, 31, 32} The current financing model faces a great sustainability challenge to support the future development of the National Immunization Program for two reasons. One reason is that county-level government bears a large proportion of National Immunization Program costs, but there is large variation in county fiscal capacity. County governments in central and western regions of China generally have lower revenue compared with eastern China—a disparity that was exacerbated by economic loss due to the COVID-19 pandemic—and are often in a difficult position to support growth of the National Immunization Program. The second reason is that revenue from non-National Immunization Program vaccine sales has decreased drastically, due to a zero-markup policy on medicines and vaccines implemented in 2016.¹¹

In recent years, the National Immunization Program has faced shortages of vaccines. In 2017, there were shortages lasting 4 months for a newly licensed bivalent oral polio vaccine, 9 months for a newly licensed inactivated poliovirus vaccine, 9 months for a meningococcal group A vaccine, and 8 months for a meningococcal group AC vaccine.³³ In 2018, six National Immunization Program vaccines—BCG; inactivated poliovirus vaccine; measles and rubella; measles, mumps, and rubella; DTaP; and meningococcal group AC—had supply shortages lasting 5–10 months.³³ Shortages were exacerbated in July, 2018, when it was discovered that the DTaP vaccine manufactured by Changsheng Bio-Technology (Changchun Jilin, China) did not meet potency criteria.³⁴ As a result, the manufacturer was ordered to stop producing the DTaP vaccine, and subsequently went out of business.³⁵ Causes of vaccine shortages include low production output due to insufficient manufacturing capacity, a prolonged manufacturing cycle to support strict quality control resulting in slower lot release by the National Medical Products Association after the Changsheng Bio-Technology incident, weak incentives for manufacturers to increase supply, low profitability of National Immunization Program vaccines, and a lack of coordination between some local CDCs and manufacturers.^{11, 29} Issues with manufacturing output and low incentives have been raised for years and recent incidents have only further exacerbated the supply shortage.^{34, 35}

There are substantial regional disparities in vaccination procedures and vaccine distribution. The Vaccines Administration Law requires standardisation of vaccination procedures and the establishment of a digital system to trace every dose of vaccine, end to end, using five separate digital identifiers—vaccine source, vaccine product, cold chain equipment, vaccinated child, and vaccinator.¹⁶ Standardisation has generally been achieved in urban regions and in wealthy rural areas of China. However, in western rural areas, village doctors, assigned by village health stations, are responsible for vaccination. Constrained by village health station resources and the low capacity of village doctors, vaccination procedures are not yet standardised, including vaccine storage and registration management. Conditions of clinics and observation rooms are not adequate. Although CDCs have established an internal cold chain system, some high-income areas have started to establish an external cold chain system to achieve point-to-point delivery. The external cold chain system is operated by professional third-party logistics companies, which has substantially increased distribution efficiency due to reduced intermediate transportation links. Less economically developed areas in western provinces, however, rely on the internal cold chain system because it is costly to hire external companies due to low distribution volume and long transportation distances. Vaccine distribution time is therefore much longer in western mountainous areas.

The National Immunization Program workforce faces challenges in improving quantity and quality. Although the size of the workforce has been increasing since 2006, the number of National Immunization Program vaccinators per 10 000 people has decreased by 3·9% in 2006, 3·8% in 2013, 1·9% in 2017, and 1·7% in 2019.²¹ During this time, the number of National Immunization Program vaccines increased, resulting in a greater workload. The insufficient number of professionals is another serious issue for the National Immunization Program, especially in epidemiology, health economics, information systems, and cold chain systems. Insufficient job quotas, inadequate financial incentives, and professional growth opportunities in CDCs are major hurdles to attracting and retaining talent. Incomes of National Immunization Program professionals in CDCs and vaccinators in health facilities have been low ever since the CDCs were established, with little change despite ongoing efforts over a number of years to increase income levels through performance payment reforms.¹¹

Immunisation information systems have several drawbacks that require improvement. First, there is no unified top-level design, resulting in fragmented information systems that are not interconnected across provinces. Duplicates of records exist in the current system, and there are regional disparities in proportions of duplicate records. Children have a unique 18-digit immunisation identification number and the immunisation information system captures the national identifications; however, duplication of records can still happen in the context of high population movement due to isolated information systems (although pilot efforts are ongoing to improve this situation). A 2017 survey of 27 provincial CDC information systems showed an average duplication rate of 2·4%, which was 4% in the eastern provinces, 0·3% in the central provinces, and 2·5% in the western provinces.²¹ Second, there are several vaccine-preventable diseases that are not notifiable infectious diseases, including varicella, invasive pneumococcal disease, and invasive Hib disease. Third, adverse events surveillance following immunisation is passive, and active vaccine safety monitoring is only at the pilot testing stage.^{23, 24} Passive safety surveillance cannot, by itself, establish quantitative associations between vaccination and putative adverse events.

Options for strengthening the National Immunization Program

Considering the challenges described above, we propose several strategic priority actions to strengthen the National Immunization Program and help its expansion and sustainable development. First, develop and implement supporting policies to strengthen enforcement of the Vaccines Administration Law, which is a milestone in the history of vaccines in China. The comprehensive legal framework covers almost every aspect of immunisation—from upstream development and production to regulation, programme implementation, monitoring of safety and influence, vaccine financing, and vaccine injury compensation. The supporting policies should be carefully designed by experts in each specific field, to ensure they are feasible.

Second, establish a working mechanism to list priority vaccines to be included in the National Immunization Program for dynamic and evidence-informed vaccine policy updates. It is important to improve the operation of the National Immunization Advisory Committee to strengthen and fulfil its expected role and to foster a more evidence-informed and disciplined way of updating the National Immunization Program in collaboration with other vaccine workshops and key government stakeholders. Updating the National Immunization Program involves a concerted and joint effort across different ministries; therefore, a steering committee for the National Immunization Advisory Committee should be established among key stakeholders, including the State Council, National Medical Products Administration, Ministry of Finance, National Healthcare Security Administration, Ministry of Science and Technology, and National Health Commission to develop strategic, visionary, and feasible working mechanisms and plans for effective National Immunization Advisory Committee operations. Furthermore, the National Immunization Advisory Committee can open its memberships to consumer representatives to allow the public to engage in discussions. Inclusion of four WHO-recommended vaccines (HPV, Hib, PCV and rotavirus vaccine) into the National Immunization Program needs to be accelerated.

Third, increase government investment and optimise the financing model of the National Immunization Program to support its expansion and sustainable development. As more than half of National Immunization Program funds have been allocated to personnel costs, it is essential for the government to continue increasing investment and allow for workforce growth. Vaccine purchase costs, which currently account for 20% of total funding, will increase with the inclusion of more vaccines. Funding for increasing the number of vaccines included in the National Immunization Program could be supported by diversifying financing channels and reducing vaccine purchase costs. Having health insurance plans that include cover for vaccines is a feasible solution that has been implemented in many countries, including the USA, with its legal mandate that insurance plans cover all US CDC recommended vaccines. Currently, China's Healthcare Security Law has forbidden the use of health insurance funds to finance any preventive health programme. However, the health insurance fund has been used as an important financing channel for COVID-19 vaccines, creating an opportunity to make further changes in terms of diversifying the financing channels for National Immunization Program vaccines. Insurance cover for vaccines is cost saving to health insurance providers, because vaccination reduces hospitalisations and doctor visits that would have had to be paid for by the insurer. Private health insurance in China could cover vaccines before they are included in the National Immunization Program. Innovative financing methods could be pilot tested; for example, a pay-it-forward strategy that offers opportunities for vaccinated people to donate for future vaccination targets.³⁶ Reducing the vaccine purchase price through joint bidding and procurement might lower the public financial burden, especially for non-programme vaccines.

Fourth, build a healthy and enabling environment for domestic vaccine manufacturers to research, develop, and produce sufficient vaccines. Adjusting the vaccine price is important, although a balance between prices and manufacturer incentives for healthy and sustainable vaccine development is also crucial. The government should create an ecosystem that incentivises vaccine manufacturers to improve research and development along with production capacity. Possible solutions include helping manufacturers enter the global vaccine market through capacity building and introduction of international goods practices and mechanisms, such as the advanced market commitment used by Gavi.³⁷ It is necessary to develop a high-level early warning and emergency vaccine shortage response plan that can be activated in a timely manner.

Fifth, strengthen the National Immunization Program workforce and continue improving the service delivery system to reduce regional disparities. Increasing financial and professional growth incentives while increasing the number of health professionals in the National Immunization Program is essential to attract and retain the talent necessary to fulfil the mission of the National Immunization Program and support its expansion. Incentives should be well designed and could include salary increases, career development training, housing policies, education, and health care. Service delivery can be improved by standardising vaccination procedures and increasing efficiency of vaccine distribution in remote western areas.

Lastly, establish a comprehensive and interconnected information system to strengthen monitoring of coverage, vaccine-preventable diseases, vaccine effectiveness, and safety to provide high-quality evidence for policy decision making. The information system should be integrated across provinces. Such integration started in 2018, and has been achieved between the national CDC and several provincial CDCs including Shandong, Tianjin, and Hubei. Further effort should be made to accelerate this process. The information system should expand its monitoring spectrum to cover vaccine-preventable diseases that are not notifiable infectious diseases. Active vaccine safety surveillance should be accelerated from the pilot projects. A good example of active vaccine safety surveillance is Australia's national vaccine safety system, AusVaxSafety, a world-leading system that achieves active surveillance by sending system-based short messages and emails to solicitate reports of adverse effects.³⁸

Conclusion

We have highlighted the remarkable achievements made by China's National Immunization Program. However, the National Immunization Program is missing several WHO-recommended vaccines and faces challenges from the health systems perspective to support expansion and future development. It is crucially important to develop and implement a set of concerted actions, as we have proposed, with adequate resourcing to strengthen the National Immunization Program. Such an effort will reduce suffering and death due to vaccine-preventable diseases in China and will contribute to Healthy China 2030 and Immunization Agenda 2030 by achieving universal coverage with life-saving vaccines.

Search strategy and selection criteria

We conducted an extensive review of published, peer-reviewed articles and reports and collected evidence from grey literature, including internal unpublished reports and insights from coauthors who have an in-depth understanding of Chinese national immunisation programmes. We obtained quantitative data from routine statistical reports published on government websites, in yearbooks, and in working reports. We conducted a systems analysis based on the WHO health system framework to identify gaps and challenges for future improvement of the National Immunization Program. We searched PubMed and Google Scholar for full-text articles in English and China National Knowledge Infrastructure for articles in Chinese, using the keywords (the same words were searched in Chinese, in the Chinese databases): “China”, “vaccine”, “immunization”, “routine immunization”, “national immunization program (NIP)”, “immunization program”, “immunization/vaccine coverage”, “vaccination coverage”, “category 1 vaccines”, “NIP vaccines”, “category 2 vaccines”, “non-NIP vaccines”, “vaccine-preventable diseases (VPDs)”, “National Immunization Advisory Committee (NIAC)”, “organization”, “governance”, “vaccines financing”, “vaccines procurement”, “immunization information system”, “surveillance system”, “immunization service delivery”, “vaccine supply”, “vaccine cold chain”, “vaccine quality”, “vaccine shortage”, “immunization workforce”, “immunization development”, and “immunization challenges.” Included articles were published from Jan 1, 2010. We reviewed the articles and selected those that contained the most relevant topics of interest, guided by the WHO health system framework. In total, we selected 15 articles written in English and 14 articles written in Chinese for final analysis. We constructed a thematic analysis framework that included the six building blocks of the WHO health system framework and extracted information from the selected articles into the framework for analysis.

Declaration of interests

We declare no competing interests.