Prevalence and Trends in Hepatitis B Virus Infection in the United States, 2015-2018.

Hepatitis B virus (HBV) is a type of viral hepatitis transmitted through sexual contact, contaminated blood, or from an infected mother to her newborn (1). HBV may cause a liver infection that is acute or short-term, but may also cause chronic or long-term infection. Vaccination was targeted to high-risk groups in 1982, and universal vaccination of newborns was recommended beginning in 1991 in the United States (2). This report provides 2015-2018 prevalence estimates of past or present HBV infection and evidence of hepatitis B vaccination, based on blood collected in the National Health and Nutrition Examination Survey (NHANES).

The impact of vaccine procurement methods on public health in selected European countries.

Introduction: Across Europe, immunization programs have brought immense benefits to the prevention of infectious diseases. The vaccines used are procured through a variety of models such as tenders and Pricing & Reimbursement. However, to date, the impact of the procurement method on the performance and sustainability of vaccination programs and on public health has received little attention.Areas covered: Drawing on a review of the academic and policy literature, complemented by an interview program with stakeholders involved in the procurement of vaccines, the authors have documented the relationship between procurement method dynamics and the level of protection against vaccine-preventable diseases in Germany, Italy, Spain and Romania for, measles-containing vaccines, hexavalent and influenza vaccines.Expert opinion: Price-based tenders can contribute to vaccine supply issues, discourage the provision of value-added services supporting vaccination coverage and disincentives future R&D. Although it is observed that price-based tenders can intensify competition in the short term, there can be unintended consequences such as damage to long-term competition. As European countries are committed to strengthen their immunization programs, they should consider the implications of current vaccine procurement models on the vaccine ecosystem and on public health.

Hepatitis B vaccine coverage in short and long stay prisons in Wales, UK 2013-2017 and the impact of the global vaccine shortage.

Data on hepatitis B vaccination coverage across prisons in Wales 2013-2017 were analysed to describe coverage of one dose, and the full hepatitis B vaccine course for men in prison. Whilst vaccination coverage increased in both short and long stay prisons, annual coverage was consistently lower in short stay prisons compared to long-stay prisons, despite short-stay prisons delivering a higher numbers of vaccine doses. The exception of this pattern was in 2017, at a time of global vaccine shortage. The data demonstrate the need for all prisons to work together to ensure men in prison can receive the full hepatitis B vaccine course. Collaborative working will be required to recover from the vaccine shortage and to achieve higher coverage than the plateau in 2016.

Hexavalent vaccines: characteristics of available products and practical considerations from a panel of Italian experts.

Combination vaccines represent a valuable technological innovation in the field of infectious disease prevention and public health, because of their great health and economic value from the individual, societal, and healthcare system perspectives. In order to increase parents' and healthcare professionals' confidence in the vaccination programs and maintain their benefits to society, more information about the benefits of innovative vaccination tools such as combination vaccines is needed. Purpose of this work is an examination of available hexavalent vaccines, that protect against Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B and Haemophilus influenzae type b infections. From the epidemiological updates of vaccine preventable diseases to the vaccine development cycle, from the immunogenicity of antigenic components to the safety and co-administration with other vaccines, several aspects of available hexavalent vaccines are discussed and deepened. Also a number of practical considerations on schedules, age of employment, strategies for vaccination recovery, vaccination in at-risk births are issued, based on the recommendations of Italian Ministry of Health, Italian Society of Pharmacology (SIF), Italian Society for Pediatrics (SIP), Italian Federation of Family Paediatricians (FIMP) and Italian Society of Hygiene, Preventive Medicine and Public Health (SItI).

Improved timely birth dose coverage of hepatitis B vaccine narrows the socio-economic inequality in western China in 2011-2016.

OBJECTIVE: To compare timely birth dose (TBD) coverage of hepatitis B vaccine and socio-economic inequality distribution of TBD coverage between 2011 and 2016 in rural areas of western China. METHODS: In western China, using multi-stage probability proportion to size sampling, 2633 and 1929 children aged 0-35 months with an immunization card were selected from 14 rural counties in 2011 and 2016, respectively. Socio-economic characteristics were obtained from face-to-face questionnaire survey and copies of vaccination certificates. We performed multivariate logistic regression models to identify the determinants of TBD coverage of hepatitis B vaccine. We grouped TBD coverage by wealth quintiles, calculated inequality using the difference base on coverage in richest (quintile 5) and poorest (quintile 1) household wealth quintiles. FINDINGS: From 2011 to 2016, the overall TBD coverage of hepatitis B vaccine among children aged 0-35 months in rural areas of western China increased from 52.8% (95% confidence interval, CI: 42.4-62.8) to 80.2% (95% CI: 69.5-87.8). The absolute difference in TBD coverage between richest and poorest quintiles was 20.6 (95%CI: 9.4-31.8) and 15.8 (95%CI: 1.4-30.2) in 2011 and 2016, respectively. CONCLUSION: The socioeconomic inequality in TBD coverage decreased over the study period, but such inequality still existed in 2016. To improve inequality in TBD, the government should pay more attention to the disadvantaged groups, especially the children who were delivered at home, or whose caregivers were ethnic minority or who have a lower level of education.

Efficacy of Hepatitis B Vaccination among Children in Special Region of Yogyakarta, Indonesia: Evaluation of Humoral and Cellular Immunity.

Hepatitis B remains a global burden, with estimated 15 to 40 percents of infected individuals eventually suffer from liver cirrhosis, liver failure, and hepatocellular carcinoma. Vaccination aims to form anti-HBs antibody with protective titer to prevent infection. CD4 T cell lymphocytes are known to play a major role in establishing immunity after vaccination. This study aimed to investigate protective titer rate among Indonesian children in Special Region of Yogyakarta following hepatitis B vaccination and correlation between anti-HBs titer and CD4 count. This is a cross-sectional study with 52 subjects between 8 months to 5 years of age in Bungas Community Health Service, Special Region of Yogyakarta, Indonesia. Anti-HBs titer was examined using enzyme immunoassay and CD4 count was examined using immunocytochemistry method. Of 52 subjects, median anti-HBs titer was 72.965 IU/L (interquartile range 360.98), mean CD4 count was 49.73% ± 29.75. Protective level of antibody was found in 73.1% of subjects. Correlation test was conducted and no correlation was found between anti-HBs titer and CD4 count (r=-0.104, p=0.464). Age was found to have a weak negative correlation with anti-HBs titer (r=-0.367, p=0.007). We found high rate of protective titer among children in Special Region of Yogyakarta who have completed hepatitis B vaccination series. No correlation was established between anti-HBs titer and CD4 count.

Estimated costs attributable to events of "out-of-temperature" in the stockpiling of hexavalent vaccines occurring in Italy.

BACKGROUND: Antigens contained in vaccines are inherently unstable biologically; such a characteristic is conferred by their three-dimensional structure. Preserving the ability of the vaccines to protect against disease is necessary to ensure the supervision and monitoring of all steps of the cold chain. DTPa-HBV-IPV/Hib vaccine (Infanrix hexaTM, GSK Vaccines, Belgium) is designed to prevent disease due to diphtheria, tetanus, pertussis (DTP), hepatitis B virus (HBV), poliomyelitis and Haemophilus influenzae type b (Hib); it was first licensed for use in Europe in 2000 and is currently licensed in at least 95 countries. Since October 2013, more than 102 million doses of GSK's DTPa-HBV-IPV/Hib vaccine have been distributed globally, with nearly 15 million doses distributed in Italy. DTPa-HBV-IPV/Hib components are stable up to a temperature of 25°C for 72 hours. Lacking of officially approved stability data may generate some concern in case of cold chain accidents. METHODS: An analysis based on collected data was carried out to estimate potential costs attributable to events of "out-of-temperature" in the stockpiling of hexavalent vaccines occurring in Italy in 2014. RESULTS: The analysis, based on real data, documented that the loss for the National Health Service (NHS) was in the range of 100,000 - 400,000 euros in one year. However, the amount of money that in principle could have been lost would have ranged between nearly half and one million euros/year. CONCLUSIONS: A substantial loss of money was avoided thanks to the availability of officially approved stability data for GSK's DTPa-HBV-IPV/Hib vaccine.

Hepatitis B virus: where do we stand and what is the next step for eradication?

Hepatitis B (HB) virus (HBV) infection, which causes liver cirrhosis and hepatocellular carcinoma, is endemic worldwide. Hepatitis B vaccines became commercially available in the 1980s. The World Health Organization recommended the integration of the HB vaccine into the national immunisation programs in all countries. HBV prevention strategies are classified into three groups: (1) universal vaccination alone; (2) universal vaccination with screening of pregnant women plus HB immune globulin (HBIG) at birth; and (3) selective vaccination with screening of pregnant women plus HBIG at birth. Most low-income countries have adopted universal vaccine programs without screening of pregnant women. However, HB vaccines are not widely used in low-income countries. The Global Alliance for Vaccine and Immunization was launched in 2000, and by 2012, the global coverage of a three-dose HB vaccine had increased to 79%. The next challenges are to further increase the coverage rate, close the gap between recommendations and routine practices, approach high-risk individuals, screen and treat chronically infected individuals, and prevent breakthrough infections. To eradicate HBV infections, strenuous efforts are required to overcome socioeconomic barriers to the HB vaccine; this task is expected to take several decades to complete.

Determination of vaccination status of pregnant women during pregnancy and the affecting factors.

AIMS AND OBJECTIVES: To determine the vaccination status of pregnant women during pregnancy and factors affecting their vaccination. BACKGROUND: Immunisation provided through vaccination is one of the most effective ways to reduce or prevent the risks of disease, disability and death. Maternal and newborn health may be protected and morbidity may be decreased through vaccinating pregnant women when necessary. DESIGN: This was a descriptive and cross-sectional survey. METHODS: This study was conducted in a university hospital in Ankara, Turkey, between 01 March and 31 May 2010. The study was carried out with 198 healthy pregnant women who had completed the 26th week of gestation. Data were collected using the data collection form composed of questions enquiring about the demographic and obstetric features of pregnant women and whether or not they knew that vaccinations could be given during pregnancy, and which vaccines could be used during pregnancy, which vaccine/vaccines they had previously received and the reasons for having been vaccinated or not. RESULTS: Approximately half of the participants had received at least one of the vaccines that may be used in pregnancy (52·0%). The pregnant women received vaccinations for tetanus (47·0%), H1N1 (9·1%), seasonal influenza (3·0%) and hepatitis B (0·5%), respectively. The pregnant women who had been educated about vaccinations had been vaccinated at a statistically significantly higher rate compared with those who had not. CONCLUSION: This study revealed that pregnant women's knowledge about the required vaccines during pregnancy affected their behaviour towards vaccination. Acquiring knowledge about vaccines that may be used during pregnancy from health personnel is effective to increase vaccination. This result may be interpreted as 'acquired information affects behaviour towards vaccination'. RELEVANCE TO CLINICAL PRACTICE: Providing information about immunisation to pregnant women at the antenatal clinic is important in terms of maternal and newborn health. Nurses and midwives working in the antenatal field should be sufficiently educated about immunisation.

The inception, achievements, and implications of the China GAVI Alliance Project on Hepatitis B Immunization.

The China GAVI Hepatitis B Immunization Project was initiated in 2002 with the signing of a Memorandum of Understanding between GAVI and the Government of China. The Project was one of the three (China, India, and Indonesia) GAVI-initiated special projects done to support countries too large to receive full GAVI support for hepatitis B vaccine and safe injections. The Project in China was designed by the Chinese Government and partners to deliver free hepatitis B vaccine and safe injections to all newborns in the 12 Western Provinces and Poverty Counties in 10 Provinces of Central China (1301 Counties with approximately 5.6 million births per year), eliminating the gap in immunization coverage between wealthier and poorer regions of China. The project budget (USD 76 million) was equally shared by GAVI and the Chinese Government. Initially planned for 5 years, two no cost extensions extended the project to 2011. Although China produced hepatitis B vaccine, before the project the vaccine was sold to parents who were also charged a "user fee" for the syringe and vaccine administration. Basic Expanded Program on Immunization (EPI) vaccines such as BCG, DTP, Polio, and measles vaccines were provided free to parents, although they were charged a user fee. Vaccines were sold by China CDC Offices at provincial, prefecture, county level and township hospitals, and village doctors received a substantial portion of their income from the sale of hepatitis B and other vaccines. The result of charging for hepatitis B vaccine was that coverage was relatively high in Eastern and wealthier counties in Central China (~80-90%), but was much lower (~40%) in Western China and Poverty Counties where parents could not afford the vaccine. The Project was administered by the China MOH and China CDC EPI program, and two Project Co-managers, one from the Chinese Government and the other an international assignee, were chosen. The project had an oversight Operational Advisory Group composed of the Chinese Government, WHO, UNICEF, and GAVI. The initial targets of the project as delineated in the initial MOU for the Project areas (HepB3 coverage will reach 85% at the county level, >75% of newborns at the county level will receive the first dose of hepatitis B within 24h of birth, and all immunization injections will be with auto disable [AD] syringes) were substantially exceeded. The differential in vaccine coverage between wealthier and poorer parts of China was eliminated contributing to a great improvement in equity. With additional contributions of the Chinese Government the Project was accomplished substantially under budget allowing for additional catch up immunization of children under 15 years of age. More than 5 million health workers were trained in how to deliver hepatitis B vaccine, timely birth dose (TBD), and safe injections, and public awareness of hepatitis B and its prevention rose significantly. TBD coverage was expedited by concurrent efforts to have women deliver in township clinics and district hospitals instead of at home. The effective management of the Project, with a Project office sitting within the China EPI and an Operational Advisory Group for oversight, could serve as a model for other GAVI projects worldwide. Most importantly, the carrier rate in Chinese children less than 5 years of age has fallen to 1%, from a level of 10% before the inception of the Project. Liver cancer, one of the major cancer killers in China (250,000-300,000 annual estimated deaths), will dramatically decline as immunized cohorts of Chinese children age. While hepatitis C and non-alcoholic liver disease also exist in China and can lead to liver cancer and cirrhosis, the majority of liver disease in China is hepatitis B related and therefore preventable. The authors believe that China's success in preventing hepatitis B is one of the greatest public health achievements of the 21st century. Work remains to be done in several key areas. There are still pockets of home births in rural provinces where a TBD is difficult to deliver, and China is strengthening its policy of screening pregnant women for HBsAg and delivering HBIG plus vaccine to newborns of HBV carrier mothers. Approximately 10% of the adult population of China remain chronic carriers of hepatitis B virus and cannot be helped by the vaccine, so prevention of liver cancer and cirrhosis in those groups remains a future challenge for China.

Improving hepatitis B vaccine timely birth dose coverage: lessons from five demonstration projects in China, 2005-2009.

BACKGROUND: Delivery of a timely (within 24h) hepatitis B vaccine birth dose (TBD) is essential to prevent the long-term complications of hepatitis B virus (HBV) infection. China made substantial progress in hepatitis B immunization coverage, however, in 2004, TBD coverage was lower in Western, poorer provinces. METHODS: We reviewed five demonstration projects for the promotion of TBD in rural counties in Qinghai, Gansu and Ningxia. Interventions consisted of (1) work to increase TBD coverage in hospitals, including training of health-care workers, (2) information, education and communication [IEC] with the population and (3) micro-plans to deliver TBD for home births. We evaluated outcome through measuring TBD coverage for home and hospital births. RESULTS: These projects were implemented in the context of national efforts to promote institutional deliveries that lead to increases ranging from 10% to 17% to reach 43-97% proportion of institutional births at the end of the projects. Among institutional births, TBD coverage increased by 2% to 13% to reach post implementation coverage ranging from 98% to 100%. Among home births, TBD coverage increased by 7% to 56% to reach post implementation coverage ranging from 29% to 88%. Overall, TBD coverage increased by 4% to 36% to reach post implementation coverage ranging from 82% to 88%. CONCLUSIONS: Demonstration projects based on combined interventions increased TBD coverage. Increases in institutional births amplified the results obtained. Use of standardized indicators for such projects would facilitate evaluation and identify intervention components that are most effective.

Origins, design and implementation of the China GAVI project.

China received GAVI support for hepatitis B vaccination in 2001 because of high disease burden and strong government will to protect infants at risk. The China/GAVI project, implemented since 2002, was funded 50% by GAVI and 50% by the Government of China. The purpose of the project was to increase coverage of hepatitis B vaccine through a pro-poor approach targeting all counties of the 12 Western provinces and poverty counties of the 10 Central provinces, to accelerate integration of hepatitis B vaccine into routine immunization, and assure immunization injection safety. The mechanism of internal coordination among multiple government entities and international cooperation was established and comprehensive strategies were used to improve vaccine coverage and injection safety. After 8 years of implementation, 193,000 health care workers in 118,316 health care facilities participated in the project, mostly at the township hospitals level (55,051) and in community centres (104,547). Through the China GAVI project, the 85% HepB3 coverage goal was reached in 98% of GAVI China project counties, the 75% timely birth dose (TBD) coverage goal was reached in 80% of GAVI project counties, and AD syringes were introduced into 100% of GAVI-supported areas. Additionally, the GAVI project was instrumental in convincing the Chinese Government to sustainably introduce and fully fund HepB vaccine for all newborns in China. The impact of hepB vaccination on HBsAg prevalence was observed throughout China, as HBsAg prevalence (previously ~10%) is now less than 1% among children under 5 years of age.

An assessment of hepatitis B vaccine introduction in India: Lessons for roll out and scale up of new vaccines in immunization programs.

BACKGROUND: Hepatitis B vaccine was introduced in the Universal Immunization Program (UIP) of 10 states of India in the year 2007-08. This assessment was planned and conducted to ascertain the reasons for low reported coverage of Hepatitis B (Hep B) vaccine in comparison of similarly timed diphtheria, pertussis, and tetanus (DPT) vaccine; to identify operational and programmatic challenges in new vaccine introductions, and to derive lessons for scale up of Hep B vaccination (or for introduction of any new vaccine) in UIP of India. MATERIALS AND METHODS: Purposive sampling with both quantitative and qualitative data collection. Two districts each were purposively selected from 5 of the 10 states, which introduced Hep B vaccine, in the year 2007-08, in India. A protocol was devised and data was collected through desk review, in-depth interviews and on-site observation at state, districts and facility levels. The assessment was completed in December 2009. RESULTS: Coverage with three doses of Hep B vaccine was lower than similarly timed three doses of DPT vaccine. Poor stock management ("stock outs or nil stocks" at various levels), incomplete recording and reporting, perceived costly vaccine & related fear of wastage of vaccine in 10 dose vial, and incomplete knowledge amongst health functionaries about vaccination schedule were the main reasons cited for reported lower coverage. Hep B vaccine birth dose was introduced in only 3 of 5 states evaluated. The additional reasons for low Hep B birth dose coverage were lack of knowledge amongst Health Workers about birth dose administration, no mechanism for recording birth dose, and insufficient trainings, official communications, and coordination at various levels. CONCLUSIONS: There had been a few challenges in the introduction of Hepatitis B vaccination in India, however, this provide opportunity to learn for future scale up. For successful introduction and expansion of any new vaccine in national or state immunization program; clear and timely central level instructions and oversight and improved stock management is required. At state and district levels; quality trainings, effective supervision and monitoring, improving data recording and reporting are key factor for success. The additional focus on Hep B birth dose administration may help in improving coverage.