32 research outputs found
Scaling up hepatitis B vaccination with the support of GAVI in China : lessons learned for introduction of new vaccines and for the future of hepatitis B control
No full textBackground: Hepatitis B virus (HBV) infection is a leading cause of illness and death in China. In 1992, 60% of the population had a history of HBV infection and 9.8% were chronically infected with HBV. Each year, an estimated 263,000 persons died from HBV-related hepatocellular carcinoma or cirrhosis, accounting for 37%-50% of HBV-related deaths worldwide before 1992. In 1992, the Ministry of Health introduced hepatitis B vaccine into the management system of the Expanded Programme on Immunization (EPI) as a cost-effective way to prevent HBV infection. The schedule included a timely birth dose (within 24 hours of birth, to prevent perinatal infections that are most strongly associated with long term chronic infections and adverse outcomes) and subsequent doses at one month and six months. However, this introduction into the EPI management system only meant that the Government took responsibility over administration and coverage monitoring, but not funding support: The cost of vaccination was covered out of pocket. As a result, coverage was lower in rural areas, in Western provinces (low economic status) and among females. In 2002, the Ministry of Health fully integrated free hepatitis B vaccine into EPI with funding from the Global Alliance for Vaccines and Immunization (GAVI). The GAVI China project financially supported vaccine and auto-disable syringes in Western provinces and poverty-affected counties of Central provinces (Chapter 1). As the GAVI China project was completed in 2010, we compiled all evaluation work conducted to understand how input and process lead to output and outcomes that impacted the heavy HBV associated burden in China.
Methods: We compiled data from GAVI China project areas between 2002 and 2009, reviewed cross-sectional studies conducted in 2004 and 2006 and conducted a final evaluation survey in 2010. These investigations covered input (funds invested into the project for vaccine and AD syringes), process (integration of the vaccine in EPI, increase in institutional births, introduction of auto-disable syringes for vaccination and training), output (immunization coverage for third dose and timely birth dose, use of auto-disable syringes for immunization), outcome (immunity in the population, safe injection practices) and impact (prevalence of HBV surface antigen among children included in the vaccination cohort).
Results: With respect to hepatitis B immunization, input included 27 million USD provided by the GAVI China project to funds hepatitis B vaccine between 2002 and 2007. These funds came from the international GAVI Alliance (50%) and the Government of China (50%). In addition, the Chinese government provided an additional 21.5 million USD in government co-funding of subsidies from central to provincial to health care workers in provinces between 2007 and 2009 so that the vaccine could be administered without user fees. The health system efficiently processed these resources. First, in GAVI-supported areas, the increase in the HepB3/DPT3 ratio (increased from 57% in 2002 to 94% in 2009), indicated indicating that EPI absorbed well the new vaccine. Second, institutionalized deliveries increased to reach 96% nationwide in 2009, indicating that maternal and child health services created conditions to maximize coverage of the timely birth dose. As a result, from 2002 to 2009, the national three-dose hepatitis B vaccine coverage progressed from 71% to 93% (Chapter 5) and the timely birth dose coverage progressed from 60% to 91% (Chapter 7) with a reduction of inequities between Eastern and Western areas. Both of these resulted in immunity among vaccinated cohorts (85% of anti-HBs among children 12 to 23 months of age in the national 2006 serological survey) (Chapter 2). One key factor strongly associated with being HBsAg negative is receiving timely birth dose of hepatitis B vaccine as early as possible (Chapter 4).
With respect to injection safety, input included 14 million USD of GAVI funds to supply auto-disable syringes, safety boxes and needle cutters. In 2009, auto-disable syringes and safety boxes were used in 78% and 79% facilities in GAVI supported areas of the Western areas, respectively (Chapter 6). In terms of output, sterilizable injection devices disappeared and attempts to re-use disposable injection equipment became rare (0% in the 2010 final evaluation). However, no data regarding the incidence of injection-associated infections were available to evaluate the outcome of the progress in injection safety.
With respect to social mobilization and training, 10 million USD were assigned to training between 2002 and 2009. Most of those were not directly funded by GAVI China. These funds were provided by the Government because of the leverage effect of the GAVI China project. These were used in 28,753 training workshops for health care workers that resulted in better knowledge among health care workers (In 2010, 98% of them knew that hepatitis B virus can be transmitted from mother to child) and guardians (In 2010, 89% of them knew that the first dose of hepatitis B vaccine had to be given in the first 24 hours of life). This higher level of knowledge also contributed to higher immunization coverage and safer injections.
Ultimately, the elements of the GAVI China project combined at the impact level to prevent HBV infections. The 2006 national serological survey documented these achievements and pointed to 1% prevalence of HBsAg among children under five years of age, a decrease of 90% from the 9.8% prevalence in the same age group in 1992 (Chapter 3). These infections prevented will lead to the future prevention of cirrhosis, hepatocellular carcinoma. Those should result in early deaths prevented and benefits in terms of disability-adjusted life years (DALYs). However, in 2010, it was too early to measure these longer term effects and the final impact of the project on HBsAg prevalence had not yet been quantified.
Conclusion: The introduction of hepatitis B vaccine into the national immunization programme was successful and the strategies and policy used for the GAVI China project provided a successful case study for the introduction of other new vaccines in China. The determinants of the success of the GAVI China included (1) a well documented disease burden, (2) a good collaboration between the government of China and the international GAVI Alliance that resulted in a strong national GAVI China project, (3) local production of vaccine and AD syringes, (4) solid processes for implementation and (5) leverage of additional support through national and provincial levels co-funding. Remaining challenges include (1) the persistence of an estimated 80,000 perinatal HBV infections each year in China, (2) the lack of homogeneous regulations to harmonize injection practices, (3) the absence of a scaled implementation for the national policy that recommends vaccination of health care workers, (4) the weak specificity and sensitivity of acute hepatitis B surveillance and (5) the absence of policy and plans for the management of chronic hepatitis B infection. We recommended that China (1) maintain universal hepatitis B infant vaccination, with a high priority to reach all infants, especially for those living in remote, mountain areas (2) make additional efforts to strengthen the health system and further improve hospital delivery rates to increase timely birth dose coverage and decrease perinatal HBV transmission, (3) develop clear surveillance guidelines to monitor acute hepatitis B rates (4) immunize health care workers, with an emphasis on pre-service delivery (5) collect manage sharps waste in a way that is safe for the health care workers, the community and the environment, and (6) screen pregnant women to administer adapted immuno-prophylaxis (including hepatitis B immune globulin, HBIG) for children born to those HBsAg positive. These should prepare the country for the next phase of a policy for the prevention and control of hepatitis B, which should ultimately include screening and treatment of patients with chronic infections, particularly those of older age cohorts who were born before the era of universal immunizatio
A Model of Regulatory Burden in Technology Diffusion: The Case of Plant-Derived Vaccines.
No full textPlant-derived vaccines may soon displace conventional vaccines. Assuming there are no major technological barriers undermining the feasibility of this innovative technology, it is worthwhile to generate quantitative models of regulatory burden of producing and diffusing plant-derived vaccines in industrialized and developing countries. A dynamic simulation model of technology diffusion—and the data to populate it—has been generated for studying regulatory barriers in the diffusion of plant-derived vaccines. The role of regulatory burden is evaluated for a variety of scenarios in which plant-derived vaccines are produced and diffused. This model relates the innovative and conventional vaccine technologies and the effects of the impact of the uptake of the innovative technology on mortality and morbidity. This case study demonstrates how dynamic simulation models can be used to assess the long-term potential impact of novel technologies in terms of a variety of socio-economic indicators.dynamic simulation model; plant-derived vaccines; regulatory burden; technology transfer; vaccines;
Riscoperte d’Oltregiogo. Luigi Fasce e la Madonna del Suffragio del Santuario della Guardia di Gavi
No full textThis paper finally gives a name to the
author of the beautiful Madonna del
Suffragio, worshipped at the Madonna
della Guardia Sanctuary, near
Gavi (AL), and at the centre of a
long story of popular devotion. The
sculptor of the wooden statue is Luigi
Fasce, born in Ovada - near Alessandria
- but grew up artistically with the
important examples given by Anton
Maria Maragliano and Francesco
Biggi, artists ver y active in the
Genoa’s area and even in the Oltregiogo,
the land between Liguria, Piedmont
and Lombardy. This study gives
stylistic, iconographic and technical
points of view to recognize Fasce’s
apprenticeship and is based even on
the data taken from the recent restoration
of this work of art
Equity and efficiency in the geographic allocation of public health resources in Mozambique
No full textEquitable and efficient health financing is crucial to improve health care provision, still inequitable in many low- and middle-income countries. The allocation of financial resources across geographic areas is important to increase the capacity to effectively provide services and their availability to the neediest population. However, how resources are transformed into service and finally reach the intended beneficiaries, depends on local health care management, on the supply-side, and on constraints to service use, on the demand-side. Equity and efficiency in the geographic allocation of public expenditure in Mozambique, and their determinants, are explored in this thesis.
First, inequities in the distribution of public health expenditure, assessed using a method based on Benefit Incidence Analysis, diminished over time due to improved resource allocation. However, inequities in health care use remain and limit the benefit from public health expenditure for the poor and neediest population. The difference between horizontal and vertical equity, assessed for each source of public health expenditure by raking individuals according to their economic wealth or to their need for health care, reveals initial discrepancies in government and donor expenditure targets and the potential trade-offs between equity objectives.
Second, inefficiencies in health care provision, assessed using Stochastic Frontier Analysis, exist at district level. Efficiency could be increased both in health administrations, where financial resources are managed to guarantee the availability of material resources, such as staff and equipment, and in health facilities, where those are used to deliver health care services. Heterogeneity in efficiency across districts depends on geographic, demographic, administrative and health system characteristics.
Third, results from an econometric model of demand for health care revealed that proximity to health facilities increases the probability of seeking care and that the availability of adequate staff and equipment can encourage service use by those who live near a health facility. Demand side constraints, mostly economic, prevent use even when services are available.
Results suggest that resource allocation policies are insufficient on their own to improve the distribution of public health expenditure. Extending health facility coverage and tackling demand-side barriers are needed to increase service use among and mitigate potential equity efficiency and horizontal-vertical equity trade-offs. Increasing the efficiency of district health administrations and health facilities can contribute to increase service use among those who live close to a health facility
Stress, Motivation and Professional Satisfaction among Health Care Workers in HIV/AIDS Care and Treatment Centers in Urban Tanzania: A Cross-Sectional Study.
No full textShortages of health care workers (HCWs) represents a serious challenge to ensuring effective HIV care in resource-limited settings (RLS). Stress, motivation, and job satisfaction have been linked with HCW retention and are important in addressing HCW shortages. In this cross-sectional study HCW stress, motivation and perceived ability to meet patient needs were assessed in PEPFAR-supported urban HIV care and treatment clinics (CTCs) in Tanzania. A self-administered questionnaire measuring motivation, stress, and perceived ability to and meet patient needs was given to HCWs at 16 CTCs. Scales measuring HCW satisfaction, motivation, and stress were developed using principle components analysis. Hierarchical linear models were used to explore the association of HCW and site characteristics with reported satisfaction, stress, motivation, and ability to meet patients' needs.\ud
Seventy-three percent (279) of HCWs completed the questionnaire. Most (73%) HCWs reported minimal/no work-related stress, with 48% reporting good/excellent motivation, but 41% also reporting feeling emotionally drained. Almost all (98%) reported feeling able to help their patients, with 68% reporting work as rewarding. Most reported receipt of training and supervision, with good availability of resources. In the multivariate model, direct clinical providers reported lower motivation than management (p < 0.05) and HCWs at medium-sized sites reported higher motivation than HCWs at larger sites (p < 0.05). HCWs at small and medium sites were more likely to feel able to help patients than those from larger sites (p < 0.05 and p < 0.001 respectively). Despite significant patient loads, HCWs in these PEPFAR-supported CTCs reported high levels of motivation, job satisfaction, ability to meet patients' needs, low levels of stress but significant emotional toll. Understanding the relationship between support systems such as strong supervision and training and these outcomes is critical in designing interventions to improve motivation, reduce stress and increase retention of HCWs
Allocating Scarce Resources Strategically - An Evaluation and Discussion of the Global Fund's Pattern of Disbursements
No full textPMCID: PMC3348932This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Pan Afr Med J
No full textIntroductionaccurate and timely laboratory diagnosis of yellow fever (YF) is critical to the Eliminate Yellow Fever Epidemics (EYE) strategy. Gavi, the Vaccine Alliance recognized the need to support and build capacity in the national and regional laboratories in the Global YF Laboratory Network (GYFLN) as part of this strategy.Methodsto better understand current capacity, gaps and needs of the GYFLN laboratories in Africa, assessments were carried out in national and regional reference laboratories in the 25 African countries at high risk for YF outbreaks that were eligible for new financial support from Gavi.Resultsthe assessments found that the GYFLN in Africa has high capacity but 21% of specimens were not tested due to lack of testing kits or reagents and approximately 50% of presumptive YF cases were not confirmed at the regional reference laboratory due to problems with shipping.Conclusionthe laboratory assessments helped to document the baseline capacities of these laboratories prior to Gavi funding to support strengthening YF laboratories.001/WHO_/World Health OrganizationInternational/34381546PMC83254721196
Institutional innovation in global health: changing roles of state and non-state actors in governance of vaccine preventable diseases
No full textThis dissertation examines the changes in global governance of vaccine preventable diseases precipitated by the transformations of national infrastructures and international institutions since the 1990s. Neoliberal policies promoted by the transnational elites prompted privatization of healthcare and decline in public healthcare expenditures and resulted in concentration of economic and political power, crumbling of the welfare state, and deepening inequalities. Emergence in public health of a new institutional form -- Public-Private Partnership (PPP), signals a reconfiguration of the governance space. I focus on one such PPP -- the Global Alliance for Vaccines and Immunization (GAVI). GAVI’s philanthropic goals are balanced against accountability to its partners. Collaborating with the pharmaceutical industry to further its philanthropic objectives, GAVI mediates the market’s pull by effecting state policies. I document the vectors of power that GAVI both exerts and is subjected to in its institutional entanglement with the states, multilateral agencies, and the industry. These mechanisms of influence are functionally different from market pressures or ‘soft’ rules of traditional multilateral organizations and forge new paths for exercising power within PPPs. Finally, I examine the networks of vaccine trade between countries from 1996 to 2010. Trade networks retain a pronounced core-periphery structure, and the majority of countries lack capacity for vaccine production. Over time some traditionally strong vaccine producers scale down, and some export-oriented developing countries, -- scale up their vaccine production. Congruent with the industrial convergence hypothesis, I find that industry late-comers no longer accrue significant returns and that some of the formerly dominant vaccine-exporting countries engage in innovative funding ventures, such as GAVI’s Advanced Market Commitment (AMC). AMC creates stable demand for new patent-protected and expensive vaccines, subsidizing the industry. I also find that industrial growth does not always reduce inequality for populations most affected by endemic diseases. I take a closer look at India as a country which houses both a thriving vaccine-producing industry and a third of the world’s un-immunized children, and examine the rift between capital accumulation and state decision making.Ph. D.Includes bibliographical referencesby Anna Da Silv
Laboratory capacity assessments in 25 African countries at high risk of yellow fever, August-December 2018.
No full textIntroduction: accurate and timely laboratory diagnosis of yellow fever (YF) is critical to the Eliminate Yellow Fever Epidemics (EYE) strategy. Gavi, the Vaccine Alliance recognized the need to support and build capacity in the national and regional laboratories in the Global YF Laboratory Network (GYFLN) as part of this strategy.
Methods: to better understand current capacity, gaps and needs of the GYFLN laboratories in Africa, assessments were carried out in national and regional reference laboratories in the 25 African countries at high risk for YF outbreaks that were eligible for new financial support from Gavi.
Results: the assessments found that the GYFLN in Africa has high capacity but 21% of specimens were not tested due to lack of testing kits or reagents and approximately 50% of presumptive YF cases were not confirmed at the regional reference laboratory due to problems with shipping.
Conclusion: the laboratory assessments helped to document the baseline capacities of these laboratories prior to Gavi funding to support strengthening YF laboratories.Peer Reviewe
Towards a sustainable, quality and affordable Haemophilus influenzae type b vaccine for every child in the world
No full textHaemophilus influenzae type b (Hib) conjugate vaccine is a safe and effective vaccine that can prevent meningitis and pneumonia caused by Hib disease. Hib vaccine is recommended for all children under 5 years. Despite the availability of safe and effective Hib vaccines since early 1987, Gambia was the only low-income country that had introduced Hib vaccine in its national immunization program. In 2000 it was reported that the disease accounted for about eight million illnesses each year resulting in approximately 400,000 deaths of children aged 1-59 months almost all in low-income countries . The introduction of Hib vaccines in these countries was limited because of the relatively high price of the vaccine and limited availability. Further, many countries lack information on the disease burden and consequently on the costeffectiveness of the vaccine. To address this problem the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM, in Bilthoven, The Netherlands) decided in 1998 to help emerging vaccine manufacturers in gaining access to Hib technology through technology transfer and thereby contributing to a sustainable supply of affordable Hib vaccines to low- and middle-income countries and to the United Nations Millennium Development Goals (MDGs) in reducing child mortality. There was no need to develop an in-house Hib vaccine for the Dutch population, as an imported Hib vaccine was already being used for years in the Dutch national immunization program. So the decision to develop a Hib vaccine was solely for technology transfer to local manufacturers (chapter 2). The Hib technology developed by RIVM was successfully transferred to Biological E (BE, India), Serum Institute of India (SII, India), Bio Farma (Indonesia) and Shanghai Institute of Biological Products (SIBP, China). The technology transfer to SIBP was facilitated by Glovax (Korea). All four partners were able to implement the process in their facilities. SII succeeded in obtaining a marketing license for their Hib vaccines in 2007 and BE was able to WHO prequalify a pentavalent vaccine including Hib in 2011. Several Hib vaccines produced by SII are now also WHO prequalified. Bio Farma decided in 2009 to use a different conjugation technology from the one transferred by RIVM/NVI1 and has licensed its Hib vaccine in 2013. Technology transfer to SIBP started in 2006, till date SIBP didn’t commercialize Hib vaccine, as the Chinese authorities decided not to allow clinical studies using this Hib vaccine since there are already sufficient other public institutes producing Hib vaccines locally. RIVM succeeded in developing an innovative, scalable, non-infringing (patents and proprietary technology), simple and affordable process for the production of quality Hib vaccines (chapter 3). The process was developed based on public information and prior knowledge on conjugate vaccines. Further, additional experiments were performed in order to support the choices made during the process development and to decide on the critical quality parameters. Recently a predictive mathematical model was developed for the Hib process. This model helped to evaluate the existing process and to study possibilities for process optimization. Besides the process and all related quality control tests, additional immuno assays were developed in order to support the development of the new Hib conjugate vaccine (chapter 4). The immuno assays developed by RIVM/NVI were very helpful during process development. All these test methods were transferred to the partners as part of the technology transfer package. Besides for the purpose of process implementation and scale up some ELISA methods were used by technology transfer partners for lot release purpose, after proper qualification and validation. The technology transfer package included all documentation related to the process, quality control tests, raw materials and equipment specifications, materials (e.g. seed lot and reference samples) and (pre)clinical data (chapter 5). The preclinical study was performed by RIVM/NVI on a clinical lot produced in close collaboration between Bio Farma (the first Hib technology transfer partner) and RIVM/NVI. Many lessons were learned during the development and technology transfer of the new Hib conjugate vaccine (chapter 6). The technology transfer partners who have used this Hib technology have made a considerable contribution to ensure sustainable supply of affordable Hib vaccines worldwide. Serum Institute of India (SII) made pentavalent vaccine (DTP-HepB-Hib) available to GAVI for 1.19,- per dose starting from 2013. SII and BE are committed to supply about 600 Million doses of this vaccine in the coming years to GAVI. Till 2007, GAVI had only one European supplier and the price of pentavalent vaccine was $3.56,- per dose. The approach followed for the Hib project can be applied to other technology transfer projects. Before starting the project an extensive and detailed feasibility study was performed to evaluate the following aspects: freedom-to-operate, prior knowledge, expected cost price of the vaccine, project continuity including impact on on-going projects, funding, potential partners and available market. Based on the outcome of this feasibility study the product target profile was defined and decisions were made on the approach to be followed during process development and technology transfer. The process developed had to allow freedom-to-operate (noninfringing with existing patents and proprietary rights) and to result in very stable intermediate and final products. Although the product to be produced using this process was a freeze-dried Hib conjugate vaccine, it was taken into consideration that technology transfer partners would eventually be aiming at a liquid formulation of both standalone and combination vaccines. As the developed process was not going to be used for routine production of the Hib vaccine in the Netherlands, all Hib technology transfer partners were advised to invest in a research infrastructure for conjugate technology in order to be able to perform further scaling up and troubleshooting after the finalization of the technology transfer. The scalability and the GMP applicability of the process were taken into consideration during process development. As part of the feasibility study performed by RIVM before being able to start the Hib project the expected cost of goods was calculated (chapter 7). The cost of goods was recalculated at a later stage using a mathematical model. COGs calculated using both methods was in the same range. The availability of a process model for Hib conjugate vaccine is advantageous because it makes it possible to perform a sensitivity analysis if certain decisions are to be taken and/or process optimization is considered. Through this Hib project, Intravacc’s partners were provided with general conjugation knowhow, and related quality control tests, resulting in a broadening of their research and development portfolio with several conjugate vaccines including meningococcal, and pneumococcal vaccine. Further, The Hib technology allowed producing freeze-dried and liquid formulations of several standalone and combination vaccines. The Hib project has also demonstrated the importance of technology transfer to local manufacturers ensuring a sustainable supply of underused vaccines to low- and middle-income countries.BiotechnologyApplied Science
