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'If a supranational goal is to achieve its intended impact, it should be based on technical evidence and have clearly defined programme strategies, process indicators and a measurable outcome goal, and there should be a definite time-line for achieving the goal. Equal emphasis needs to be placed on the final outcome and the process used to achieve it. The proposal that achievement of the hepatitis B control goal should be independently certified using well-defined criteria is innovative, and has previously been applied only to disease-eradication goals. The independent certification process will involve few additional costs and regular reporting of results will maintain both a sense of urgency and pressure to improve performance.'
Good reading.
BD
The authors’ abstract:
Vaccination against hepatitis B: the Chinese experience |
ZHOU Yi-hua, WU Chao, ZHUANG Hui |
ZHOU Yi-hua Department of Laboratory Medicine, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu 210008, China; WU Chao Department of Infectious Diseases, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu 210008, China; ZHUANG Hui Department of Microbiology, Peking University Health Science Center, Beijing 100191, China |
Hepatitis B virus (HBV) infection is a serious health problem worldwide. Globally, it is estimated that over 2 billion persons have evidence of past HBV infection, more than 350 million are chronic carriers, and some one million deaths annually are attributed to HBV-related diseases. One of the distinct characteristics of HBV infection is that the chronicity greatly depends upon the age: infections occurred in neonates and in childhood result in 80%–90% and 30%–50% chronic carriage respectively; in contrast, only 5%–10% of infections become chronic in adolescence and adulthood.1 Once chronic infection is established, HBV may persist in the liver for lifetime,2,3 which not only causes severe HBV-related sequelae such as cirrhosis and hepatocellular carcinoma but also constitutes the reservoir of the virus.
HBV infection is highly endemic in China; transmission during the perinatal period and the early childhood is the most important infection mode.4 Thus, prevention of HBV infection in infants and preschool children through vaccination with hepatitis B vaccine is the most critical strategy to control HBV infection in China. Chinese health authorities have put the prevention of HBV infection as a high priority, and China is one of the two first countries in the developing world to attempt to control HBV infection by mass immunization of hepatitis B vaccine.5
The first hepatitis B vaccine, derived from human carrier plasma, was licensed in the US in 1981. Since having the largest population in the world, China must produce its own vaccine against hepatitis B; extensive investigations on the development of the vaccine were conducted using HBsAg purified from human carriers.6-8 A locally produced plasma-derived hepatitis B vaccine in China became available in 1986. The vaccine, which is used by intramuscular injection with 3 doses, usually on a schedule of 0, 1, and 6 months respectively (Table), was proved to be safe and highly effective for preventing HBV infection in infants born to HBV carrier mothers in clinical trials9-11 as reported in other countries or regions. The home-made vaccine also showed to be long-term effective, for at least up to 20 years.12 Concurrent use of the vaccine and hepatitis B immunoglobulin (HBIG) showed better protection in neonates born to mothers positive for both HBsAg and hepatitis B e antigen (HBeAg).
To raise the hepatitis B vaccine coverage, beginning in 2002, the China health authorities provided all neonates with free hepatitis B vaccine but charged their parents for the injection service fee. Meanwhile, the Ministry of Health of China initiated a project together with the Global Alliance for Vaccines and Immunization to vaccinate free-of-charge all neonates in 12 China′s western provinces and in the poorest counties of 10 other provinces. The 5-year project covered 1031 out of the total 2862 counties and 470 million population, with vaccination of 5.84 million of neonates annually.20 A survey in 11 of the 12 western provinces showed that the average timely birth-dose coverage reached to 88.6% among neonates born in township hospitals and 89.8%–96.6% among those born in city and province hospitals in 2005,21 whereas the timely birth-dose coverage in neonates was 46.5% in township hospitals and 61.2% in city and province hospitals in the same region in 1998 and 1999.22 Accordingly, the coverage with 3 doses of the vaccine also increased significantly.23 The data indicate that providing the vaccine with no charges would improve the both timely birth-dose and full vaccination coverage.
Since China has a vast, geographically diverse territory and world′s largest population, many residents are living in remote or isolated areas with poor health services. The hepatitis B vaccine coverage in these areas was much lower than that in other areas. A survey in Huangnan County, which is located in Qinghai Province and over 3000 m above the sea level, showed that, in 2004, the timely birth-dose coverage was only 42.6% and the coverage with 3 doses of the vaccine was only 46.5%.25 After reinforcing health education, training the health providers, improving transportation and increasing the percentage of neonates delivered in hospitals, strengthening the coordination among village doctors, vaccinators, midwives and mothers, setting up regular vaccine distributions to remote and isolated areas, and using auto-disposable syringes for all immunization injections, the timely birth-dose coverage increased to 75.0% in 2005 in the same areas.26
A nationwide seroprevalence survey conducted in 1979, in which HBsAg was detected with reverse passive hemagglutination assay in sera of 266 728 residents from all provinces except for Taiwan across the country, showed that the overall HBsAg positive rate was 8.8% (3.8%–16.8%) and the rate in rural area was higher than in cities (10.2% vs 7.9%).31 In children under 1 year of age, the prevalence of HBsAg ranged from 3.8% to 7.0%, and the prevalence reached the peak with 12.6% in 5 years old children in rural areas and with 9.1% at 9 years old in cities.31 Other national surveys with the more sensitive radioactive immunoassay in 4039 sera from five provinces and in 10 484 sera from four provinces revealed HBsAg carriage rate was 10.3% and 10.1% respectively.32,33 These data were validated by subsequent numerous investigations conducted by local health departments. Generally, some 10% of Chinese populations before mass hepatitis B vaccination were chronic HBsAg carriers.
CONCLUSION
The implementation of universal infant vaccination against hepatitis B in China is being rewarded by reduction in incidences of HBV infections and chronic carrier rate. The success is the result of national continuous efforts to control this disease: designation of hepatitis B as one of the four high priority diseases for national control, domestically produced vaccines, effective coordination among health departments and the other relevant agencies, new national vaccination regulations, strong international partnerships, and dedication of countless healthcare workers are most critical for the achievement. The Chinese experience highlights the importance of hepatitis B vaccination in control of HBV infection, and indicates that HBV infection can be controlled also in any unindustrialized country whoever is committed to control this disease.
1. Zuckerman J, van Hattum J, Cafferkey M, Gjorup I, Hoel T, Rummukainen ML, et al. Should hepatitis B vaccination be introduced into childhood immunisation programmes in northern Europe? Lancet Infect Dis 2007; 7: 410-419.
2. Poland GA, Jacobson RM. Clinical practice: prevention of hepatitis B with the hepatitis B vaccine. N Engl J Med 2004; 351: 2832-2838.
3. Jia JD, Zhuang H. A winning war against hepatitis B virus infection in China. Chin Med J 2007; 120: 2157-2158.
4. Yao GB. Importance of perinatal versus horizontal transmission of hepatitis B virus infection in China. Gut 1996; 38 Suppl 2: s39-s42.
5. Gust ID. Epidemiology of hepatitis B infection in the Western Pacific and South East Asia. Gut 1996; 38 Suppl 2: s18-s23.
6. Tao QM, Huang DY, Feng BF, Wu PX, Liu YZ, Li XF, et al. A preliminary study on hepatitis B vaccine. Chin Med J 1978; 4: 101-110.
7. Tao QM, Wang JQ, Feng BF, Li XF, Du SC, Liu YZ. Further research on the hepatitis B vaccine. J Beijing Med Coll (Chin) 1980; 12: 223-226.
8. Xie Y, Wang J, Zhang G, Wang L. Purification of HBsAg from human placental blood by density-gradient zonal centrifugation. J Med Virol 1981; 7: 171-178.
9. Duan SC, Xu ZY, Xu HF, Wang DM, Wen YM, Zhu QR, et al. Study of efficacy of hepatitis B vaccine in blockage of perinatal transmission of HBV by detection of serum HBV RNA. Chin J Pediatr (Chin) 1985; 23: 136-138.
10. Xu ZY. Mother-to-infant transmission of hepatitis B virus and its prevention in China. Chin J Pediatr (Chin) 1985; 23: 185-186.
11. Kang Y, Meng LX, Li X, Li Y, Liu FY, Mei YX, et al. Two year observation of immune response in infants of HBeAg positive mothers to hepatitis B vaccine. Chin J Microbiol Immunol (Chin) 1986; 6: 111-112.
12. Mo ZJ, Shen LP, Yang JY, Zhou KJ, Li YP, Wei ZL, et al. Study on the relationship between hepatitis B vaccination and sero epidemiology of infective status of hepatitis B virus. Chin J Vac Immun (Chin) 2007; 13: 216-218.
13. Ren GF, Mei YF, Wang S, Chen H, Wang W, Zhu JM, et al. Clinical trial in children population of a recombinant vaccine consisting of the major protein of hepatitis B virus surface antigen. Chin J Virol (Chin) 1991; 7: 203-208.
14. Zhang Q, Zhang X, Yie S, Wang T, Xu G, Jia G, et al. Antibody response in children and adults and interruption of perinatal transmission of hepatitis B virus with a recombinant vaccine prepared from transgenic Chinese hamster ovary cell line. Chin J Virol (Chin) 1991; 7 Suppl: s108-s113.
15. Zhuang H. Hepatitis B vaccination in China. In: Jilbert AR, Grgacic EVL, Vickery K, Burrell CJ, Cossart YE. eds. Proceedings of the 11th International Symposium on Viral Hepatitis & Liver Disease. Sydney: Australian Centre for Hepatitis Virology; 2004: 229-233.
16. Zeng XJ, Yang HG, Miao SS, Chen AP, Tan J, Huang ZJ, et al. A study on the coverage, strategy and cost of hepatitis B vaccination in China, 1996. Chin J Epidemiol (Chin) 1998; 19: 277-281.
17. Zhu X, Zhang XL, Chai F, Wang KA. The hepatitis B vaccine coverage rate in 10 Chinese provinces and its influence factors. Chin J Vac Immun (Chin) 1998; 4: 217-221.
18. Jia ZY, Wu GZ, Su CA, Huang YY, Li YQ, Yang CM, et al. An investigation on hepatitis B vaccination of newborns in four provincial capital cities and suburbs. Chin J Vac Immun (Chin) 1999; 5: 258-261.
19. Disease Control Department of Ministry of Health of China. National EPI vaccination and hepatitis B coverage rate and the related factors: results from the 1999 national coverage survey. Chin J Vac Immun (Chin) 2000; 6: 193-197.
20. Li M. The GAVI project in China. Chin J Pub Health Manag (Chin) 2004; 20: 411-413.
21. Cui FQ, Hu YS, Lu Y, Purha T, Chen YS, Li JJ, et al. Analysis on timely birth dose coverage among infant born in different places in western provinces of China. Chin J Vac Immun (Chin) 2007; 13: 313-315.
22. Zhou YQ, Wang HQ, Guo X, Liang XF. Investigation on coverage rate of the first hepatitis B vaccine for new entrance students of primary school in 12 provinces (autonomous regions and municipalities) of West China. Dis Surveil (Chin) 2007; 22: 325-327.
23. Cui FQ, Lu Y, Hu YS, Chen YS, Hadler S, Cao LS, et al. Analysis on hepatitis B vaccine integration into national immunization program for children in China. Chin J Vac Immun (Chin) 2006; 12: 241-245.
24. Cui FQ, Purha T, Hadler S, Liang XF. Analysis on new born hepatitis B immunization coverage and pregnant women hospital delivery rate in different regions. Chin J Vac Immun (Chin) 2007; 13: 1-3.
25. Li CN, Wan MJ, Li XQ, Zhang YJ, Zhang XW, Ba WS, et al. Study on birthtime coverage and correlative factors in Huangnan prefecture of Qinghai Province in 2004. Chin J Vac Immun (Chin) 2007; 13: 37-39.
26. Zhang YJ, Hu YS, Zhang XW, Shi XA, Wan MJ, Li QQ, et al. Strategy on improving the birth time coverage in Huangnan Prefecture of Qinghai Province. Chin J Vac Immun (Chin) 2007; 13: 40-42.
27. Wang SS, Xu ZY, Maynard JE, Prince AM, Beasley RP, Yang JY, et al. Evaluation of the hepatitis B model immunization program in Long′an County, China. J Guangxi Prev Med (Chin) 1995; 1: 1-4.
28. Just M, Berger R. Immunogenicity of a heat-treated recombinant hepatitis B vaccine. Vaccine 1988; 6: 399-400.
29. Li FJ, Li JH, Chen C, Xia W, Wang LX, Chen HP, et al. Strategy on improving the timeliness of hepatitis B vaccine birth dose in remote rural areas. Chin J Vac Immun (Chin) 2006; 12: 254-258.
30. Wang L, Li J, Chen H, Li F, Armstrong GL, Nelson C, et al. Hepatitis B vaccination of newborn infants in rural China: evaluation of a village-based, out-of-cold-chain delivery strategy. Bull World Health Organ 2007; 85: 688-694.
31. Qu ZY. An epidemiological study on the distribution of HBsAg and anti-HBs in China. Chin J Microbiol Immunol (Chin) 1986; 6 Suppl: 20-40.
32. Hu ZH, Qu ZY, Jing Q, Ding ZR, Bai ZY, Cao LZ, et al. The overall infection rate of HBV in Chinese general population by sampling investigation. Chin J Microbiol Immunol (Chin) 1986; 6 Suppl: 72-79.
33. Liu CB, Xu ZY, Cao HL, Sun YD, Chen DB, Jing Q, et al. Seroepidemiology of HBV infection in four provinces in China. Chin J Virol (Chin) 1991; 7 Suppl: 8-14.
34. Gong XH, Xing YL, Liu LR, Shen L. Supervision and analysis for immune effect and immunization coverage rate of hepatitis B vaccine among preschool children in Beijing in three different years. Chin J Vac Immun (Chin) 1999; 5: 262-265.
35. Gong XH, Li YH, Liu LR, Jia L, Xing YL, Wang YQ. Study on the efficacy of hepatitis B immunization among youngsters in Beijing. Chin J Epidemiol (Chin) 2004; 25: 388-390.
36. Jia ZY, Wu GZ, Su CA, Huang YY, Li YQ, Yang CM, et al. An investigation on hepatitis B vaccination of newborns in four provincial capital cities and suburbs. Chin J Vac Immun (Chin) 1999; 5: 258-261.
37. Wei ZL, Yang JY, Li RC, Li YP, Nong Y, Gong J, et al. Investigation on immunization coverage rate and immune effect of hepatitis B vaccine in Guangxi Zhuangzu Autonomous Region. Chin J Vac Immun (Chin) 1999; 5: 269-271.
38. Yan TQ, Wang JJ. The effect of hepatitis B vaccination of newborns on the prevalent rate of HBV infection in children. Chin J Vac Immun (Chin) 2002; 8: 65-68.
39. Tian C, Ma JC, Han CZ, Qi SX, Hao ZY, Zhang ZY, et al. Infective status of HBV among population after 19 years immunization vaccine. Chin J Vac Immun (Chin) 2007; 13: 4-7.
40. Zhuang H. The current status of hepatitis B virus infection in China. In: The proceedings of the 13th Chinese Symposium on Viral Hepatitis and Liver Diseases Shanghai, Society of Infectious Diseases and Society of Hepatology, Chinese Medical Association; 2007: 15.