Developing Countries Vaccine Manufacturers Network (DCVMN): Engaging to step up for vaccine discovery and access. Meeting Report 2012

At the annual general meeting of the Developing Countries Vaccine Manufacturers Network (DCVMN) members renewed their engagement and cooperative spirit in pursuing the mission of increasing the quality and availability of affordable vaccines for all people.     

Challenges to changing health behaviours in developing countries: a critical overview

This overview of recent research on health behaviour change in developing countries shows progress as well as pitfalls. In order to provide guidance to health and social scientists seeking to change common practices that contribute to illness and death, there needs to be a common approach to developing interventions and evaluating their outcomes. Strategies forming the basis of interventions and programs to change behaviour need to focus on three sources: theories of behaviour change, evidence for the success and failure of past attempts, and an in-depth understanding of one's audience. Common pitfalls are a lack of attention to the wisdom of theories that address strategies of change at the individual, interpersonal, and community levels. Instead, programs are often developed solely from a logic model, formative qualitative research, or a case-control study of determinants. These are relevant, but limited in scope. Also limited is the focus solely on one's specific behaviour; regardless of whether the practice concerns feeding children or seeking skilled birth attendants or using a latrine, commonalities among behaviours allow generalizability. What we aim for is a set of guidelines for best practices in interventions and programs, as well as a metric to assess whether the program includes these practices. Some fields have approached closer to this goal than others. This special issue of behaviour change interventions in developing countries adds to our understanding of where we are now and what we need to do to realize more gains in the future.     

The data for decision making project: assessment of surveillance systems in developing countries to improve access to public health information

OBJECTIVE: By using timely, high-quality information, ministries of health can identify and address priority health problems in their populations more effectively and efficiently. The Data for Decision Making (DDM) project developed a conceptual model for a data-driven health system. This model included a systematic methodology for assessing access to information to be used as a basis for improvement in national health surveillance systems. STUDY DESIGN AND METHODS: The DDM surveillance assessment methodology was applied to six systems in five countries by staff from the US Centers for Disease Control and Prevention (CDC). Ministry of health personnel at national, regional, district and local levels were interviewed using either informal conversation or an interview guide approach, and their methods for collecting and using data were reviewed. Attributes of timeliness, accuracy, simplicity, flexibility, acceptability and usefulness were examined. Problems and their underlying causes were identified. RESULTS: The problems preventing decision makers from having access to information are many and complex. The assessments identified no fewer than eight problem areas that impeded decision makers' access to information. The most common deficiencies were concerning the design of the system, ongoing training of personnel and dissemination of data from the system. CONCLUSIONS: To improve the availability of information to public health decision makers, it is recommended that: (a) surveillance system improvement begins with a thorough evaluation of existing systems using approaches outlined by the CDC and the Health Metric Network of the World Health Organization; (b) evaluations be designed to identify specific causes of these deficiencies; (c) interventions for improving systems be directly linked to results of the evaluations; and (d) efforts to improve surveillance systems include sustained attention to underlying issues of training and staff support. The assessment tool presented in this report can be used to facilitate this process.     

Roles of pharmacists in expanding access to safe and effective medical abortion in developing countries: a review of the literature

Unsafe abortion continues to be a major contributor to maternal mortality and morbidity around the world. This article examines the role of pharmacists in expanding women's access to safe medical abortion in Latin America, Africa, and Asia. Available research shows that although pharmacists and pharmacy workers often sell abortion medications to women, accurate information about how to use the medications safely and effectively is rarely offered. No publication covered effective interventions by pharmacists to expand access to medical abortion, but lessons can be learned from successful interventions with other reproductive health services. To better serve women, increasing awareness and improving training for pharmacists and pharmacy workers about unsafe abortion - and medications that can safely induce abortion - are needed.     

The medical importance of vitamin A and carotenoids (with particular reference to developing countries) and their determination

Vitamin A, or retinol, is an essential nutrient for man and all mammalian species since it cannot be synthesised within the body. Deficiency of the vitamin results in adverse effects on growth, reproduction and resistance to infection. The most important manifestation of severe vitamin A deficiency (VAD) is xerophthalmia, and irreversible blindness may eventually occur in one or both eyes. VAD is still an important micronutrient deficiency problem in many developing countries, afflicting large numbers of pre-school children. It is often associated with protein-energy malnutrition, parasitic infestation and diarrhoeal disease. For many communities in developing countries, the major source of vitamin A in the diet is carotenoids. These compounds are synthesised only by photosynthetic microorganisms and by members of the plant kingdom where they serve important functions in metabolism, including participating in the photosynthetic process. These pigments also provide aesthetic qualities as colourants in the plant and animal kingdoms. Most importantly, the carotenoids serve the animal kingdom as sources of vitamin A activity. Major advances have occurred in understanding the role and mechanisms of action of carotenoids. They are now thought to play specific roles in mammalian tissues related to their function in plants. Carotenoids, with their highly reactive conjugated double bonds, act as free radical traps or antioxidants and may play an important role in the prevention of cancers. In view of the wide medical importance of carotenoids, much attention has been given to the determination of these pigments in foods as well as blood. Carotenoids in foods have conventionally been analysed using the open-column chromatography technique, but the high-pressure liquid chromatographic (HPLC) method is now gaining in importance as well. The classical method for the determination of carotenoids in blood is by the spectrophotometric method while the HPLC method is also recommended for use. An example of an HPLC method developed for the simultaneous determination of retinol and carotenoids in food and blood is given. The determination of retinol and carotenoids should be further developed in view of the wide importance of carotenoids in health and disease.     

The determinants of dermal exposure ranking method (DERM): a pesticide exposure assessment approach for developing countries

A new method for assessment of dermal exposure to pesticides in subsistence farmers by use of determinants of dermal exposure is described. The method, called the determinants of dermal exposure ranking method (DERM), is a combination of checklists and expert rating assessment. Thus, determinants are listed in a form, which is used to check their presence and to assess them using a simple algorithm based on two factors, the type of transport process (T value) and the area of body surface exposed (A value). In addition, the type of clothing worn during applications is included as a protection factor. We applied the DERM to real pesticide applications, characterizing dermal exposure and comparing DERM estimates with earlier developed semiquantitative visual scores based on fluorescent tracer, the total visual score (TVS) and contaminated body area (CBA). DERM showed a very good level of agreement with both the TVS (r = 0.69; P = 0.000) and the CBA (r = 0.67; P = 0.000). DERM allowed identification of the determinants that had the highest effect on exposure and the farmers with the highest exposure. In conclusion, DERM provided information on the determinants responsible for dermal exposure in a group of subsistence farmers. This can be useful to design monitoring and preventive programs, define priorities for intervention and prioritize and select most adequate measurement strategies. DERM promises to be a low-cost easy-to-use method to assess dermal exposure to pesticides in developing country conditions.     

Analysis of strategies to successfully vaccinate infants in developing countries against enterotoxigenic E. coli (ETEC) disease

Enterotoxigenic Escherichia coli (ETEC) is the most common bacterial cause of diarrhoea in the world, annually affecting up to 400,000,000 children under 5 years of age living in developing countries (DCs). Although ETEC possesses numerous antigens, the relatively conserved colonization factor (CF) antigens and the heat labile enterotoxin (LT) have been associated with protection and most vaccine candidates have exploited these antigens. A safe and effective vaccine against ETEC is a feasible goal as supported by the acquisition of protective immunity. The success of an ETEC vaccine targeting infants and children in DCs will depend on a combination of maximally antigenic vaccine preparations and regimens for their delivery which will produce optimal immune responses to these antigens. Vaccine candidates having a high priority for accelerated development and clinical testing for eventual use in infants would include inactivated ETEC or Shigella hybrids expressing ETEC antigens as well as attenuated ETEC strains which express the major CF antigens and LT toxin B-subunit, as well as attenuated Shigella, Vibrio cholerae and Salmonella typhi hybrids engineered to deliver antigens of ETEC. Candidates for an ETEC vaccine would have to meet the minimal requirement of providing at least 50% protection against severe disease in DCs during the first 2 years of life. The critical roadblock to achieving this goal has not been the science as much as the lack of a sufficiently funded and focused effort to bring it to realization. However, a Product Development Partnership to overcome this hurdle could accelerate the time lines towards when control of ETEC disease in DCs is substantially closer.     

The global financial crisis has led to a slowdown in growth of funding to improve health in many developing countries

How has funding to developing countries for health improvement changed in the wake of the global financial crisis? The question is vital for policy making, planning, and advocacy purposes in donor and recipient countries alike. We measured the total amount of financial and in-kind assistance that flowed from both public and private channels to improve health in developing countries during the period 1990-2011. The data for the years 1990-2009 reflect disbursements, while the numbers for 2010 and 2011 are preliminary estimates. Development assistance for health continued to grow in 2011, but the rate of growth was low. We estimate that assistance for health grew by 4 percent each year from 2009 to 2011, reaching a total of $27.73 billion. This growth was largely driven by the World Bank's International Bank for Reconstruction and Development and appeared to be a deliberate strategy in response to the global economic crisis. Assistance for health from bilateral agencies grew by only 4 percent, or $444.08 million, largely because the United States slowed its development assistance for health. Health funding through UN agencies stagnated, and the Global Fund to Fight AIDS, Tuberculosis, and Malaria announced that it would make no new grants for the next two years because of declines in funding. Given the international community's focus on meeting the Millennium Development Goals by 2015 and persistent economic hardship in donor countries, continued measurement of development assistance for health is essential for policy making.     

The epidemiologic transition to chronic diseases in developing countries: Cardiovascular mortality, morbidity, and risk factors in Seychelles (Indian Ocean)

Summary The occurrence of cardiovascular diseases (CVD) and related risk factors was evaluated in Seychelles, a middle level income country, as accumulating evidence supports increasing rates of CVD in developing countries, CVD mortality was obtained from vital statistics for two periods, 1984–5 and 1991–3, CVD morbidity was estimated by retrospective review of discharge diagnoses for all admissions to medical wards in 1990–1992. Levels of CVD risk factors in the population were assessed in 1989 through a population-based survey. In 1991–93, standardized mortality rates were in males and females respectively, 80.9 and 38.8 for cerebrovascular disease and 92.9 and 47.0 for ischemic heart disease. CVD accounted for 25.2% of all admissions to medical wards. Among the general population aged 35–63, 30% had high blood pressure, 52% of males smoked, and 28% of females were obese. These findings substantiate the current health fransition to CVD in Seychelles. More generally, epidemiologic data on CVD mortality, morbidity, and related risk factors, as well as similarindicators for other chronic diseases, should more consistently appear in national and international reports of human development to help emphasize, in the health policy making scene, the current transition to chronic diseases in developing countries and the subsequent need for appropriate control and prevention programs.

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Zusammenfassung Während zwei Perioden wurden in den Seychellen Daten über Herz kreislaufkrankheiten (HKK) erhoben. Die Mortalitätsdaten stammen von den Mortalitätsstatistiken. Morbiditätsdaten Wurden mittels einer retrospektiven Studie der Spitalaustrittsdiagnosen erfasst. Den Risikofaktoren für HKK wurde in einer Bevölkerungserhebung nachgegangen. 1991 bis 1993 betrugen die standardisierten Mortalitätsraten für zerebrovaskuläre Krankheiten 80,9 (Männer) und 38,8 (Frauen), für die koronare Herzkrankheit 92,9 (Männer) und 47,0 (Frauen). HKK machten 25,2% aller Spitaleinweisungen aus. In der 35 bis 64 jährigen Bevölkerung wiesen 30% eine Hypertonie auf; 52% der Männer waren Raucher und 28% der Frauen waren übergewichtig. Aus den erhobenen. Daten geht hervor, dass sich den Seychellen ein Übergang zur HKK absoielt. Generell sollte dieser epidemiologische Übergang zu chronischen Krankheiten, wie man sie in den Entwicklungsländern sieht, vermehrt in Betracht gezogen werden, wenn auf nationaler und internationaler Ebene die Gesundheitspolitik entschieden wird.

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Résumé L'apparition des maladies cardio-vasculaires (MCV) et leurs facteurs de risque ont été évalués aux Seychelles, pays à niveau de revenu intermédiaire entre les pays en voie de développement (PVD) et les pays industrialisés. En effet, des éléments de plus en plus nombreux attestent d'une augmentation de l'incidence des MCV dans certains pays en développement. La mortalité par maladies cardio-vasculaires a été mesurée à partir des statistiques vitales pour les periodes 1984–85 et 1991–93. La morbídité a été estimée rétrospectivement sur la base des lettres de sorties de toutes les admissions des hôpitaux de 1990–92. Le niveau des facteurs de risque dans la population a été évalué en 1989 dans le cadre d'une étude spécifique. Durant la période 1991–93, les taux de mortalité standardisés étaient de 80.9 et 38.8 pour les maladies cérébrovasculaires et de 92.9 et 47.0 pour les MCV chez les hommes et les femmes respectivement. Les MCV représentaient 25.2% des admissions hospitalières. Pour les facteurs de risque dans la population générále de 35–64 ans, on comptait 30% d'hypertension artérielle, 52% de fumeurs chez les hommes, alors que 28% des femmes etaient obèses Ces chiffres vont dans le sens d'une situation dite de transition pour les MCV aux Seychelles. Plus généralement les données épidémiologìques concemant la mortalité, la morbidité et les facteurs de risques cardiovasculaires ainsi que des éléments concernant les autres maladies chroniques, devraient apparaitre plus systermatiquement dans les rapports statistiques nationaux et internationaux. On pourrait de cette façon mieux mettre en évidence la transition épidémiologique vers les maladies chroniques dans les PVD et défendre la nécessité d'en tenir compte dans les politiques de santé ainsi que dans les programmes de prevention.

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Investigators of the Seychelles Heart Study     

Unequal access to vaccines in the WHO European Region during the A(H1N1) influenza pandemic in 2009

In a severe pandemic, rapid production and deployment of vaccines will potentially be critical in mitigating the impact on populations and essential services. We compared access to vaccines and timing of delivery relative to identification of A(H1N1)pdm09 and the geographic progression of the pandemic in the WHO European Region in order to identify gaps in provision. Information on vaccine procurement and donations was collected through a web-based survey conducted in all 53 member states of the Region. Among the 51 countries responding to the survey, the majority (84%) implemented vaccination campaigns against A(H1N1)pdm09. However, time of vaccine receipt and number of doses varied substantially across the region, with delayed access in many countries especially in those in the lowest income range. Improving access to influenza vaccines in low resource countries and solving issues of product liability should help reduce inequalities and operational challenges arising during a future public health crisis.     

The European Sero-Epidemiology Network 2 (ESEN2): standardization of assay results for hepatitis A virus (HAV) to enable comparisons of seroprevalence data across 15 countries

The European Sero-Epidemiology Network 2 (ESEN2) aimed to compare serological results of vaccine-preventable diseases across Europe. To ensure direct inter-country comparability of hepatitis A virus antibody (anti-HAV) measurements, a standardization panel of 150 sera was developed by a designated reference laboratory and tested by participating national laboratories using assays of choice; each country's results were subsequently regressed against those of the reference laboratory. Quantitatively, the assays were generally highly correlated (R2>0.90). Nevertheless, qualitative comparisons indicated that results obtained with different assays may differ despite the usage of well-established international and local standards. To a great extent standardization successfully alleviated such differences. The generated standardization equations will be used to convert national serological results into common units to enable direct international comparisons of HAV seroprevalence data. The results of this study are expected to contribute to the evaluation and potential improvement of the currently employed immunization strategies for hepatitis in Europe.     

Sometimes (what seems to be) a heart attack is (really) a pain in the neck

A 31-year-old patient complained of severe crushing chest pain that radiated to his left arm and jaw. After admission to the hospital, tests revealed a normal electrocardiogram, normal treadmill, normal coronary arteriogram, and normal cardiac enzymes. However, the patient continued to have pain, which was relieved by sublingual and intravenous nitroglycerine. He was discharged from the hospital with a diagnosis of "musculoskeletal" chest pain, taking nonsteroidal anti-inflammatory drugs, muscle relaxants, and narcotics. Two weeks later, the patient returned with worsening symptoms. Cardiac work-up was again negative. Thoracic and cervical spine radiographs were ordered for possible discogenic pain. After abnormalities were found on cervical radiographs, magnetic resonance imaging (MRI) was ordered, and the patient was referred to an orthopedic surgeon. Further work-up revealed a herniated disk at C6-C7, with radicular pain. Surgery on the suspect disk totally relieved the patient's pain.     

A Transdisciplinary Complex Adaptive Systems (T-CAS) Approach to Developing a National School-Based Culture of Prevention for Health Improvement: the School Health Research Network (SHRN) in Wales

Prevention Science - The paper reflects on a transdisciplinary complex adaptive systems (T-CAS) approach to the development of a school health research network (SHRN) in Wales for a national...     

The seasonality of bacterial quality of water in a tropical developing country (Sierra Leone)

Natural water sources used as drinking-water supplies by rural settlements in Sierra Leone were examined monthly over a one-year period to detect any seasonal variations in bacterial quality. The 37 degrees C colony count, levels of selected faecal indicator bacteria and the incidence of Salmonella spp. were monitored. A seasonality was demonstrated for all the variables, counts generally increasing with the progression of the dry season, culminating in peaks at the transition from dry to wet season. Some complications with respect to the interpretation of counts of faecal indicator bacteria from raw tropical waters are noted.     

Generation of Th1 immune responses to inactivated,gp120-depleted HIV-1 in mice with a dominant Th2 biased immune profile via immunostimulatory [correction of imunostimulatory] oligonucleotides--relevance to AIDS vaccines in developing countries

Vaccination against HIV-1 of hosts with a dominant Th2 immune profile may fail to induce essential protective Th1 immune responses. By using Schistosoma-infected mice, with a pre-existent Th2 immune background, we demonstrate that oligodeoxynucleotides (ODN) containing unmethylated cytosine-phosphate-guanosine (CpG) immunostimulatory sequences co-administered with inactivated, gp120-depleted HIV-1 viral particles (HIV-1 immunogen) lead to potent Th1 anti-HIV-1 immune responses overcoming the Th2 bias. In contrast, Schistosoma-infected mice immunized with HIV-1 immunogen in incomplete Freund's adjuvant only, induced Th2 anti-HIV-1 immune responses. These findings strongly support the advisability of using CpG ODN as a Th1 inducing adjuvant when immunizing human populations with a strong pre-existent Th2 immune profile.     

Patient Adherence to Three Dose Completion of the Quadrivalent Human Papillomavirus (HPV) Vaccine in a Private Practice

The human papillomavirus quadrivalent (types 6, 11, 16, and 18) recombinant vaccine is effective in preventing cervical, vulvar, vaginal and anal cancer. Maximal protection is achieved with completion of all three recommended doses. A retrospective chart review was performed to (1) assess the current vaccine series completion rates in a private practice multispecialty suburban setting and (2) identify factors associated with failure to complete the vaccine series. Chi-square and independent samples t test were used for data analysis. A total of 4,117 patients out of 10,821 eligible patients received at least one dose of the HPV vaccine between October 1, 2006 and April 30, 2010. Overall, 69.5?% (n?=?2,863) of patients who received one dose of the HPV vaccine completed all three doses in a valid time frame, representing 26.5?% of all eligible patients. Patients who completed the series were younger (16.8 vs. 18.2, p?<?0.05), less likely to have a sexually transmitted disease diagnosis prior to initiation of the series (57.7 vs. 69.8?%, p?<?0.05), and more likely to have visited the pediatrics department compared to family medicine, internal medicine, and OB/GYN departments (75.9, 65.7, 57.0, 60.9?%, respectively, p?<?0.05). Deaths, pregnancies, and adverse drug reactions were not identified as independent factors impacting completion rates. The results indicate that adolescents, patients visiting the pediatrics department and those without a prior STD diagnosis completed the vaccination series more frequently than adults managed in family medicine, internal medicine, and OB/GYN departments.     

A descriptive analysis of transgender participants in phase 1-2a trials of the HIV Vaccine Trials Network (HVTN) in the United States and Peru

BackgroundHIV disproportionately impacts transgender populations globally, creating challenges to inclusion in trials requiring low HIV risk profiles (LHRP) for acquisition. Our knowledge of transgender individuals with LHRP is limited. We conducted an analysis of transgender and cisgender individuals in HVTN trials enrolling individuals with LHRP.MethodsWe analyzed data from 694 participants enrolled in the phase 1-2a HVTN trials in the US and Peru from 2009 to 2014 that included individuals who reported gender identity (GI) differing from assigned birth sex (transgender [TG]), and compared them with those who reported a congruent GI (cisgender [CG]).Results681 participants (98%) were CG and 13 (2%) were TG. Mean age was 25 years. 16% were Hispanic and most (69%) were White. Reasons for enrolling included to help find an effective vaccine (TG 100%; CG 98%) and help their community (TG 100%; CG 96%). Significant differences by GI were observed in reported pre-existing conditions (p = 0.004); however, approximately 10% of pre-existing conditions reported by TG were GI-related (e.g., gender dysphoria). Significant differences were observed in hormone therapy use (p < 0.001) and mental health medications (p = 0.007). Retention was excellent with 2.1% missed visits and no discontinuations of vaccination for TG and 3% missed visits and 7.1% discontinuations among CG. There was no statistically significant difference in HIV incidence.ConclusionsPrimary reasons for participation were altruistic for all participants. Comparable to CG counterparts, TG participants maintained LHRP, followed trial procedures, and had high retention, facilitating meaningful early phase HIV preventive vaccine trial contributions.