FDA [to 28 November 2015]

FDA [to 28 November 2015]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

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FDA approves first seasonal influenza vaccine containing an adjuvant
November 24, 2015 – The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.

Fluad, which is manufactured using an egg-based process, is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil. Squalene, a naturally occurring substance found in humans, animals and plants, is highly purified for the vaccine manufacturing process. Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual.

According to the Centers for Disease Control and Prevention, in recent years, it is estimated that 80 to 90 percent of seasonal influenza-related deaths and 50 to 70 percent of seasonal influenza-related hospitalizations have occurred among people 65 years of age and older.

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FDA approves vaccine for use after known or suspected anthrax exposure
November 23, 2015 – The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.

Anthrax disease, especially the inhalation form, is often fatal if not promptly treated. Anthrax is considered one of the more likely agents to be used in a biological attack, primarily because its spores are very stable and easy to disperse. Although it is rare, people may contract anthrax disease through natural exposures, such as contact with infected animals or contaminated animal products.

“With today’s approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to anthrax spores,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

IVI [to 28 November 2015]

IVI [to 28 November 2015]
http://www.ivi.org/web/www/home

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IVI Statement: “It is a matter of time before dengue in Southeast Asia becomes endemic in South Korea”
2015.11.25
An interview with Dr. In-Kyu Yoon, Director of the Dengue Vaccine Initiative and IVI’s Deputy Director General of Science was recently featured in Dong-A Ilbo, South Korea’s third largest daily newspaper and publisher of Dong-A Science, the top science magazine in the nation. In the interview he talks about the possibility of dengue spreading to South Korea. The interview, which was published in Korean, has been translated into English. Read the original interview here (Korean only): http://news.donga.com/3/all/20151124/74977500/1

European Vaccine Initiative [to 28 November 2015]

European Vaccine Initiative [to 28 November 2015]
http://www.euvaccine.eu/news-events

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EVI Scientific Advisory Committee (SAC) takes on two new members
25 November 2015
The two new EVI SAC members are: Chetan Chitnis, Professor and Head of Malaria Parasite Biology & Vaccines Unit, Institut Pasteur, Paris, and Nancy Le Cam Bouveret, Independent Clinical Development and Regulatory Consultant.

EDCTP [to 28 November 2015]

EDCTP [to 28 November 2015]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials.

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24 November 2015
New EDCTP-TDR Clinical Research and Development Fellowships awarded
24 November 2015
A total of 18 product development clinicians from 9 low- and middle-income countries have been awarded clinical research and development fellowships. These fellows are supported by TDR, the Special Programme for Research and Training in Tropical Diseases, and will be placed with 10 host institutions by early 2016.

Health care workers in Pearl River Delta Area of China are not vaccinated adequately against hepatitis B: a retrospective cohort study

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 28 November 2015)

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Research article
Health care workers in Pearl River Delta Area of China are not vaccinated adequately against hepatitis B: a retrospective cohort study
Yu-Bao Zheng, Yu-Rong Gu, Min Zhang, Ke Wang, Zhan-lian Huang, Chao-Shuang Lin, Zhi-Liang Gao BMC Infectious Diseases 2015, 15:542 (22 November 2015)
Abstract
Backgrounds
Health-care workers’ (HCWs) exposure to bodily fluids puts them at risk of hepatitis B virus HBV infection. This study investigated HBV vaccination practices and outcomes in HCWs and assessed postvaccination seroprotection across HCWs in different departments.
Methods
A survey of HCWs in a Chinese public general hospital was carried out with a retrospective cohort of 1420 hospital HCWs (458 males and 962 females). HBV vaccination status (10-μg/dose used) was investigated in the cohort from vaccination records from the period of 1988 to 2008. Blood samples were collected and tested for hepatitis B surface antigen (HBsAg) and HBV antibodies (anti-HBs).
Results
The overall vaccination (complete course) and HBsAg carrier rates among HCWs were 40.42 % (574/1420) and 6.13 % (87/1420), respectively. Vaccination rates differed by department, with HCWs in internal medicine (39.5 %) and emergency (42.0 %) departments having particularly low rates. The natural infection rate was 7.53 % (107/1420) among HCWs. HCWs in the department of infectious diseases (vaccination rate, 57.8 %) had the highest rate of antibody produced by natural infection (88.2 %).
Conclusion
The vaccination rate was a disappointingly low among HCWs in Pearl River Delta Area of China. HCWs working in infectious diseases departments and technicians were at particularly likely to have been infected with HBV. A concerted effort is needed to bring vaccination rates up among Chinese HCWs in Pearl River Delta Area of southern China.

Direct observation of respectful maternity care in five countries: a cross-sectional study of health facilities in East and Southern Africa

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 28 November 2015)

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Research article
Direct observation of respectful maternity care in five countries: a cross-sectional study of health facilities in East and Southern Africa
Heather Rosen, Pamela Lynam, Catherine Carr, Veronica Reis, Jim Ricca, Eva Bazant, Linda Bartlett, on behalf of the Quality of Maternal and Newborn Care Study Group of the Maternal and Child Health Integrated Program
BMC Pregnancy and Childbirth 2015, 15:306 (23 November 2015)
Abstract
Background
Poor quality of care at health facilities is a barrier to pregnant women and their families accessing skilled care. Increasing evidence from low resource countries suggests care women receive during labor and childbirth is sometimes rude, disrespectful, abusive, and not responsive to their needs. However, little is known about how frequently women experience these behaviors. This study is one of the first to report prevalence of respectful maternity care and disrespectful and abusive behavior at facilities in multiple low resource countries.
Methods
Structured, standardized clinical observation checklists were used to directly observe quality of care at facilities in five countries: Ethiopia, Kenya, Madagascar, Rwanda, and the United Republic of Tanzania. Respectful care was represented by 10 items describing actions the provider should take to ensure the client was informed and able to make choices about her care, and that her dignity and privacy were respected. For each country, percentage of women receiving these practices and delivery room privacy conditions were calculated. Clinical observers’ open-ended comments were also analyzed to identify examples of disrespect and abuse.
Results
A total of 2164 labor and delivery observations were conducted at hospitals and health centers. Encouragingly, women overall were treated with dignity and in a supportive manner by providers, but many women experienced poor interactions with providers and were not well-informed about their care. Both physical and verbal abuse of women were observed during the study. The most frequently mentioned form of disrespect and abuse in the open-ended comments was abandonment and neglect.
Conclusions
Efforts to increase use of facility-based maternity care in low income countries are unlikely to achieve desired gains if there is no improvement in quality of care provided, especially elements of respectful care. This analysis identified insufficient communication and information sharing by providers as well as delays in care and abandonment of laboring women as deficiencies in respectful care. Failure to adopt a patient-centered approach and a lack of health system resources are contributing structural factors. Further research is needed to understand these barriers and develop effective interventions to promote respectful care in this context.

BMC Public Health (Accessed 28 November 2015)

BMC Public Health
http://www.biomedcentral.com/bmcpublichealth/content
(Accessed 28 November 2015)

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Research article
Provider costs for prevention and treatment of cardiovascular and related conditions in low- and middle-income countries: a systematic review
Elizabeth Brouwer, David Watkins, Zachary Olson, Jane Goett, Rachel Nugent, Carol Levin
BMC Public Health 2015, 15:1183 (26 November 2015)

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Research article
A systematic review of studies evaluating Australian indigenous community development projects: the extent of community participation, their methodological quality and their outcomes
Mieke Snijder, Anthony Shakeshaft, Annemarie Wagemakers, Anne Stephens, Bianca Calabria BMC Public Health 2015, 15:1154 (21 November 2015)

Clinical Therapeutics – November 2015

Clinical Therapeutics
November 2015 Volume 37, Issue 11, p2385-2608
http://www.clinicaltherapeutics.com/current

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Review of the Persistence of Herpes Zoster Vaccine Efficacy in Clinical Trials
Stephen J. Cook, Dennis K. Flaherty
p2388–2397
Published online: October 23 2015
Abstract
The live attenuated herpes zoster vaccine* was approved for the prevention of shingles in 2006. Initial Phase III clinical trials proved vaccine efficacy persisted during the study duration; however, assessment of long-term efficacy required additional studies. This article reviews efficacy data for the zoster vaccine that have been published since 2004. It focuses on studies assessing declining vaccine efficacy.

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Commentary
Personal Protective Equipment: Protecting Health Care Providers in an Ebola Outbreak
William A. Fischer II, David J. Weber, David A. Wohl
p2402–2410
Published online: October 6 2015
Preview
The recent Ebola epidemic that devastated West Africa has infected and killed more health care providers than any other outbreak in the history of this virus. An improved understanding of pathogen transmission and the institution of strategies to protect health care providers against infection are needed in infectious disease outbreaks. This review connects what is known about Ebola virus transmission with personal protective equipment (PPE) designed to arrest nosocomial transmission.

Conceptual and institutional gaps: understanding how the WHO can become a more effective cross-sectoral collaborator

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 28 November 2015]

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Research
Conceptual and institutional gaps: understanding how the WHO can become a more effective cross-sectoral collaborator
Gopinathan U, Watts N, Hougendobler D, Lefebvre A, Cheung A, Hoffman SJ and Røttingen JA Globalization and Health 2015, 11:46 (24 November 2015)
Abstract
Background
Two themes consistently emerge from the broad range of academics, policymakers and opinion leaders who have proposed changes to the World Health Organization (WHO): that reform efforts are too slow, and that they do too little to strengthen WHO’s capacity to facilitate cross-sectoral collaboration. This study seeks to identify possible explanations for the challenges WHO faces in addressing the broader determinants of health, and the potential opportunities for working across sectors.
Methods
This qualitative study used a mixed methods approach of semi-structured interviews and document review. Five interviewees were selected by stratified purposive sampling within a sampling frame of approximately 45 potential interviewees, and a targeted document review was conducted. All interviewees were senior WHO staff at the department director level or above. Thematic analysis was used to analyze data from interview transcripts, field notes, and the document review, and data coded during the analysis was analyzed against three central research questions. First, how does WHO conceptualize its mandate in global health? Second, what are the barriers and enablers to enhancing cross-sectoral collaboration between WHO and other intergovernmental organizations? Third, how do the dominant conceptual frames and the identified barriers and enablers to cross-sectoral collaboration interact?
Results
Analysis of the interviews and documents revealed three main themes: 1) WHO’s role must evolve to meet the global challenges and societal changes of the 21st century; 2) WHO’s cross-sectoral engagement is hampered internally by a dominant biomedical view of health, and the prevailing institutions and incentives that entrench this view; and 3) WHO’s cross-sectoral engagement is hampered externally by siloed areas of focus for each intergovernmental organization, and the lack of adequate conceptual frameworks and institutional mechanisms to facilitate engagement across siloes.
Conclusion
There are a number of external and internal pressures on WHO which have created an organizational culture and operational structure that focuses on a narrow, technical approach to global health, prioritizing disease-based, siloed interventions over more complex approaches that span sectors. The broader approach to promoting human health and wellbeing, which is conceptualized in WHO’s constitution, requires cultural and institutional changes for it to be fully implemented.

Making fair choices on the path to universal health coverage: a précis

Health Economics, Policy and Law
Volume 11 – Issue 01 – January 2016
http://journals.cambridge.org/action/displayIssue?jid=HEP&tab=currentissue

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Special Section
Making fair choices on the path to universal health coverage: a précis
Alex Voorhoevea1 c1, Trygve Ottersena2 and Ole F. Norheima2
a1 Philosophy, Logic, and Scientific Method, London School of Economics, UK
a2 Department of Global Public Health and Primary Care, University of Bergen, Norway
Abstract
We outline key conclusions of the World Health Organisation’s report ‘Making Fair Choices on the Path to Universal Health Coverage (UHC)’. The Report argues that three principles should inform choices on the path to UHC: I. Coverage should be based on need, with extra weight given to the needs of the worse off; II. One aim should be to generate the greatest total improvement in health; III. Contributions should be based on ability to pay and not need. We describe how these principles determine which trade-offs are (un)acceptable. We also discuss which institutions contribute to fair and accountable choices.

Human Vaccines & Immunotherapeutics – Volume 11, Issue 11, 2015

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 11, Issue 11, 2015
http://www.tandfonline.com/toc/khvi20/current

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Vaccination of healthcare workers: A review
pages 2522-2537
DOI:10.1080/21645515.2015.1082014
Skerdi Haviari, Thomas Bénet, Mitra Saadatian-Elahi, Philippe André, Pierre Loulergue & Philippe Vanhems
Abstract
Vaccine-preventable diseases are a significant cause of morbidity and mortality. As new vaccines are proving to be effective and as the incidence of some infections decreases, vaccination practices are changing. Healthcare workers (HCWs) are particularly exposed to and play a role in nosocomial transmission, which makes them an important target group for vaccination. Most vaccine-preventable diseases still carry a significant risk of resurgence and have caused outbreaks in recent years. While many professional societies favor vaccination of HCWs as well as the general population, recommendations differ from country to country. In turn, vaccination coverage varies widely for each microorganism and for each country, making hospitals and clinics vulnerable to outbreaks. Vaccine mandates and non-mandatory strategies are the subject of ongoing research and controversies. Optimal approaches to increase coverage and turn the healthcare workforce into an efficient barrier against infectious diseases are still being debated.

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Immunization of pregnant women: Future of early infant protection
pages 2549-2555
DOI:10.1080/21645515.2015.1070984
Azure N Faucette, Michael D Pawlitz, Bo Pei, Fayi Yao & Kang Chen
Abstract
Children in early infancy do not mount effective antibody responses to many vaccines against commons infectious pathogens, which results in a window of increased susceptibility or severity infections. In addition, vaccine-preventable infections are among the leading causes of morbidity in pregnant women. Immunization during pregnancy can generate maternal immune protection as well as elicit the production and transfer of antibodies cross the placenta and via breastfeeding to provide early infant protection. Several successful vaccines are now recommended to all pregnant women worldwide. However, significant gaps exist in our understanding of the efficacy and safety of other vaccines and in women with conditions associated with increased susceptible to high-risk pregnancies. Public acceptance of maternal immunization remained to be improved. Broader success of maternal immunization will rely on the integration of advances in basic science in vaccine design and evaluation and carefully planned clinical trials that are inclusive to pregnant women.

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Vaccinations in prisons: A shot in the arm for community health
pages 2615-2626
Open access
DOI:10.1080/21645515.2015.1051269
Víctor-Guillermo Sequera, Salomé Valencia, Alberto L García-Basteiro, Andrés Marco & José M Bayas
Abstract
From the first day of imprisonment, prisoners are exposed to and expose other prisoners to various communicable diseases, many of which are vaccine-preventable. The risk of acquiring these diseases during the prison sentence exceeds that of the general population. This excess risk may be explained by various causes; some due to the structural and logistical problems of prisons and others to habitual or acquired behaviors during imprisonment. Prison is, for many inmates, an opportunity to access health care, and is therefore an ideal opportunity to update adult vaccination schedules. The traditional idea that prisons are intended to ensure public safety should be complemented by the contribution they can make in improving community health, providing a more comprehensive vision of safety that includes public health.

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Vaccine-preventable diseases in humanitarian emergencies among refugee and internally-displaced populations
pages 2627-2636
DOI:10.1080/21645515.2015.1096457
Eugene Lam, Amanda McCarthy & Muireann Brennan
Abstract
Humanitarian emergencies may result in breakdown of regular health services including routine vaccination programs. Displaced populations including refugees and internally displaced persons are particularly susceptible to outbreaks of communicable diseases such as vaccine-preventable diseases (VPDs). Common VPDs encountered in humanitarian emergencies include measles, polio, and depending on geographical location, meningococcal meningitis, yellow fever, hepatitis A, and cholera. We conducted a review of 50 published articles from 2000 to 2015 concerning VPDs in humanitarian emergencies. This article provides an update on the available literature regarding vaccinations among this highly vulnerable population and describes the unique challenges of VPDs during humanitarian emergencies. Humanitarian emergencies place affected populations at risk for elevated morbidity and mortality from VPDs due to creation or exacerbation of factors associated with disease transmission such as mass population movements, overcrowding, malnutrition, and poor water and sanitation conditions. Vaccination is one of the most basic and critical health interventions for protecting vulnerable populations during emergencies. Growing insecurity, as seen in the increasing number of targeted attacks on health workers in recent years, as well as destruction of cold chain and infrastructure for transportation of supplies, are creating new challenges in provision of life saving vaccines in conflict settings. Population displacement can also threaten global VPD eradication and elimination efforts. While highly effective vaccines and guidelines to combat VPDs are available, the trend of increasing number of humanitarian emergencies globally poses new and emerging challenges in providing vaccination among displaced populations.

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Research Paper
Immunizing nomadic children and livestock – Experience in North East Zone of Somalia
pages 2637-2639
DOI:10.1080/21645515.2015.1038682
Raoul Kamadjeua*, Abraham Mulugetab, Dhananjoy Guptac, Abdirisak Abshir Hirsid, Asalif Belaynehb, Marianne Clark-Hattinghc, Clement Adamsc, Payenda Abedc, Brenda Kyeyunec, Tajudin Ahmedb, Mohamed Salihe, Cyprien Biaoue & Brigitte Tourea
Abstract
Nomads and pastoralists represent around 30% of the population of North East zone of Somalia (Puntland) and have very limited access to basic health including immunization. During the 2013–2014 polio outbreak in Somalia, an increase number of polio cases notified health services among these underserved communities highlighted the urgent need to devise innovative strategies to reach them. Harnessing the high demand for veterinary services among pastoralist communities, the Ministry of Health and the Ministry of Livestock, with support from UNICEF, WHO and FAO launched an integrated human and animal vaccination campaign on 19 October 2014. Over 30 days, 20 social mobilizers conducted shelter to shelter social mobilization and interpersonal communication for nomadic/pastoralist hamlets, 20 human vaccination teams, accompanied by local community elders, traveled with animal vaccination teams to administer polio and measles vaccination to pastoralist communities in the 5 regions of Puntland. 26,393 children (0 to 10 years) received Oral Polio Vaccine (OPV) out of which 34% for the first time ever; 23,099 were vaccinated against measles. and 12,556 Vitamin A. Despite various operational challenges and a significantly higher operational cost of $6.2 per child reached with OPV, the integrated human and animal vaccination campaign was effective in reaching the unvaccinated children from nomadic and pastoralist communities of Somalia.

JAMA – November 24, 2015

JAMA
November 24, 2015, Vol 314, No. 20
http://jama.jamanetwork.com/issue.aspx

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Viewpoint | November 24, 2015
Forced Migration – The Human Face of a Health Crisis
Lawrence O. Gostin, JD1; Anna E. Roberts, LLB, MIPH1
Extract
This Viewpoint discusses ways in which countries can help safeguard the rights and health of refugees, asylum-seekers, and forced migrants.
Addressing a joint session of Congress, Pope Francis said that migrants “travel for a better life.…Is that not what we want for our own children?”1 With that plea, the pontiff placed a human face on the modern migration crisis, with nearly 60 million refugees, asylum-seekers, and internally displaced persons (IDPs) fleeing predominantly from war-torn Syria, Afghanistan, and Somalia2; children comprise half the group. The global response is wholly incommensurate with the need: the European Union agreed to distribute only 120 000 asylum-seekers, and the United States will increase its annual refugee cap from 70 000 to 100 000 by 2017—neither of which will substantially affect the humanitarian crisis.

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Original Investigation | November 24, 2015
Prevalence of Body Mass Index Lower Than 16 Among Women in Low- and Middle-Income Countries
Fahad Razak, MD, MSc1,2,3; Daniel J. Corsi, PhD3,4; Arthur S. Slutsky, MD, MASc1,2; Anura Kurpad, MD, PhD5; Lisa Berkman, PhD3; Andreas Laupacis, MD, MSc1,2; S. V. Subramanian, PhD3
Abstract
Importance
Body mass index (BMI) lower than 16 is the most severe category of adult undernutrition and is associated with substantial morbidity, increased mortality, and poor maternal-fetal outcomes such as low-birth-weight newborns. Little is known about the prevalence and distribution of BMI lower than 16 in low- and middle-income countries (LMIC).
Objective
To determine the prevalence and distribution of BMI lower than 16 and its change in prevalence over time in women in LMIC.
Design, Settings, and Participants
Cross-sectional data analysis composed of nationally representative surveys from 1993 through 2012 from the Demographic and Health Surveys Program. Women aged 20 through 49 years from 60 LMIC (N = 500 761) and a subset of 40 countries with repeated surveys (N = 604 144) were examined.
Exposures
Wealth was measured using a validated asset index, age was categorized in deciles, education by highest completed level (none, primary, secondary, or greater), and place of residence as urban vs rural.
Main Outcomes and Measures
The primary outcome was BMI lower than 16. Analyses assessed the prevalence of BMI lower than 16, its association with sociodemographic factors, and change in prevalence. Logistic regression models were used to calculate odds ratios (ORs), adjusting for survey design and age structure.
Results
Among countries examined, the pooled, weighted, and age-standardized prevalence of BMI lower than 16 was 1.8% (95% CI, 1.7% to 1.8%) with the highest prevalence in India (6.2% [95% CI, 5.9% to 6.5%]), followed by Bangladesh (3.9% [95% CI, 3.4% to 4.3%]), Madagascar (3.4% [95% CI, 2.8% to 4.0%], Timor-Leste (2.9% [95% CI, 2.4% to 3.2%]), Senegal (2.5% [95% CI, 1.9% to 3.2%]), and Sierra Leone (2.2% [95% CI, 1.3% to 3.0%]); and 6 countries had prevalences lower than 0.1% (Albania, Bolivia, Egypt, Peru, Swaziland, and Turkey). The prevalence of BMI lower than 16 in women with a secondary or higher education level was 0.51% (95% CI, 0.47% to 0.55%), and in mutually adjusted models, a less than primary education level was associated with an OR of 1.4 (95% CI, 1.2 to 1.6). The prevalence of BMI lower than 16 was 0.43% (95% CI, 0.37% to 0.48%) in the highest wealth quintile with an OR of 3.0 (95% CI, 2.4 to 3.7) in the lowest wealth quintile. Among the 24 of 39 countries with repeated surveys, there was no decrease in prevalence. In Bangladesh and India, rates were declining with an average absolute change annually of −0.52% (95% CI, −0.58% to −0.46%) in Bangladesh and −0.11% (95% CI, −0.12% to −0.10%) in India.
Conclusions and Relevance
Among women in 60 LMIC, the prevalence of BMI lower than 16 was 1.8%, and was associated with poverty and low education levels. Prevalence of BMI lower than 16 did not decrease over time in most countries studied.

The Lancet – Nov 28, 2015

The Lancet
Nov 28, 2015 Volume 386 Number 10009 p2117-2226 e45
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
The Global Burden of Diseases: living with disability
The Lancet
DOI: http://dx.doi.org/10.1016/S0140-6736(15)01096-X
Summary
The UN observes the International Day of Persons with Disabilities on Dec 3, 2015. This year, three themes are highlighted in the agenda: making cities inclusive for all, improving disability data and statistics, and including those with invisible disabilities in society and development. These themes echo the specific mention of persons with disabilities in five of the Sustainable Development Goals (SDGs): education; economic growth and employment; creation of inclusive, safe, resilient, and sustainable cities; reduction of inequalities; and data collection related to monitoring the SDGs.

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Editorial
Ebola: lessons for future pandemics
The Lancet
DOI: http://dx.doi.org/10.1016/S0140-6736(15)01097-1
Summary
At the time of writing, hopes that the devastating west African Ebola outbreak was finally coming to its end were diminished by the recent confirmation of three new cases of the disease in Liberia. The country had previously been declared Ebola free on Sept 3—followed by Sierra Leone on Nov 7 and Guinea on Nov 19. The outbreak, which killed more than 11 000 people and infected at least 28 000, is the largest of its kind and a stark reminder of the fragility of health security in an interdependent world.

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Global, regional, and national disability-adjusted life years (DALYs) for 306 diseases and injuries and healthy life expectancy (HALE) for 188 countries, 1990–2013: quantifying the epidemiological transition
GBD 2013 DALYs and HALE Collaborators Christopher J L Murray et al
Summary
Background
The Global Burden of Disease Study 2013 (GBD 2013) aims to bring together all available epidemiological data using a coherent measurement framework, standardised estimation methods, and transparent data sources to enable comparisons of health loss over time and across causes, age–sex groups, and countries. The GBD can be used to generate summary measures such as disability-adjusted life-years (DALYs) and healthy life expectancy (HALE) that make possible comparative assessments of broad epidemiological patterns across countries and time. These summary measures can also be used to quantify the component of variation in epidemiology that is related to sociodemographic development.
Methods
We used the published GBD 2013 data for age-specific mortality, years of life lost due to premature mortality (YLLs), and years lived with disability (YLDs) to calculate DALYs and HALE for 1990, 1995, 2000, 2005, 2010, and 2013 for 188 countries. We calculated HALE using the Sullivan method; 95% uncertainty intervals (UIs) represent uncertainty in age-specific death rates and YLDs per person for each country, age, sex, and year. We estimated DALYs for 306 causes for each country as the sum of YLLs and YLDs; 95% UIs represent uncertainty in YLL and YLD rates. We quantified patterns of the epidemiological transition with a composite indicator of sociodemographic status, which we constructed from income per person, average years of schooling after age 15 years, and the total fertility rate and mean age of the population. We applied hierarchical regression to DALY rates by cause across countries to decompose variance related to the sociodemographic status variable, country, and time.
Findings
Worldwide, from 1990 to 2013, life expectancy at birth rose by 6·2 years (95% UI 5·6–6·6), from 65·3 years (65·0–65·6) in 1990 to 71·5 years (71·0–71·9) in 2013, HALE at birth rose by 5·4 years (4·9–5·8), from 56·9 years (54·5–59·1) to 62·3 years (59·7–64·8), total DALYs fell by 3·6% (0·3–7·4), and age-standardised DALY rates per 100 000 people fell by 26·7% (24·6–29·1). For communicable, maternal, neonatal, and nutritional disorders, global DALY numbers, crude rates, and age-standardised rates have all declined between 1990 and 2013, whereas for non–communicable diseases, global DALYs have been increasing, DALY rates have remained nearly constant, and age-standardised DALY rates declined during the same period. From 2005 to 2013, the number of DALYs increased for most specific non-communicable diseases, including cardiovascular diseases and neoplasms, in addition to dengue, food-borne trematodes, and leishmaniasis; DALYs decreased for nearly all other causes. By 2013, the five leading causes of DALYs were ischaemic heart disease, lower respiratory infections, cerebrovascular disease, low back and neck pain, and road injuries. Sociodemographic status explained more than 50% of the variance between countries and over time for diarrhoea, lower respiratory infections, and other common infectious diseases; maternal disorders; neonatal disorders; nutritional deficiencies; other communicable, maternal, neonatal, and nutritional diseases; musculoskeletal disorders; and other non-communicable diseases. However, sociodemographic status explained less than 10% of the variance in DALY rates for cardiovascular diseases; chronic respiratory diseases; cirrhosis; diabetes, urogenital, blood, and endocrine diseases; unintentional injuries; and self-harm and interpersonal violence. Predictably, increased sociodemographic status was associated with a shift in burden from YLLs to YLDs, driven by declines in YLLs and increases in YLDs from musculoskeletal disorders, neurological disorders, and mental and substance use disorders. In most country-specific estimates, the increase in life expectancy was greater than that in HALE. Leading causes of DALYs are highly variable across countries.
Interpretation
Global health is improving. Population growth and ageing have driven up numbers of DALYs, but crude rates have remained relatively constant, showing that progress in health does not mean fewer demands on health systems. The notion of an epidemiological transition—in which increasing sociodemographic status brings structured change in disease burden—is useful, but there is tremendous variation in burden of disease that is not associated with sociodemographic status. This further underscores the need for country-specific assessments of DALYs and HALE to appropriately inform health policy decisions and attendant actions.
Funding
Bill & Melinda Gates Foundation.

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Health Policy
Will Ebola change the game? Ten essential reforms before the next pandemic. The report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola
Suerie Moon, Devi Sridhar, Muhammad A Pate, Ashish K Jha, Chelsea Clinton, Sophie Delaunay, Valnora Edwin, Mosoka Fallah, David P Fidler, Laurie Garrett, Eric Goosby, Lawrence O Gostin, David L Heymann, Kelley Lee, Gabriel M Leung, J Stephen Morrison, Jorge Saavedra, Marcel Tanner, Jennifer A Leigh, Benjamin Hawkins, Liana R Woskie, Peter Piot
Summary
The west African Ebola epidemic that began in 2013 exposed deep inadequacies in the national and international institutions responsible for protecting the public from the far-reaching human, social, economic, and political consequences of infectious disease outbreaks. The Ebola epidemic raised a crucial question: what reforms are needed to mend the fragile global system for outbreak prevention and response, rebuild confidence, and prevent future disasters? To address this question, the Harvard Global Health Institute and the London School of Hygiene & Tropical Medicine jointly launched the Independent Panel on the Global Response to Ebola.

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Viewpoint
The International Health Regulations 10 years on: the governing framework for global health security
Prof Lawrence O Gostin, JD, Mary C DeBartolo, JD, Eric A Friedman, JD
Published Online: 22 November 2015
Summary
Fundamental revisions to the International Health Regulations in 2005 were meant to herald a new era of global health security and cooperation. Yet, 10 years later, the International Health Regulations face criticism, particularly after the west African Ebola epidemic. Several high-level panels1 are reviewing the International Health Regulations’ functions and urging reforms.2 The Global Health Security Agenda, a multilateral partnership focused on preventing, detecting, and responding to natural, accidental, or intentional disease outbreaks, has similar capacity building aims, but operates largely outside the International Health Regulations.

The HIV Treatment Gap: Estimates of the Financial Resources Needed versus Available for Scale-Up of Antiretroviral Therapy in 97 Countries from 2015 to 2020

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 28 November 2015)

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The HIV Treatment Gap: Estimates of the Financial Resources Needed versus Available for Scale-Up of Antiretroviral Therapy in 97 Countries from 2015 to 2020
Arin Dutta, Catherine Barker, Ashley Kallarakal
Research Article | published 24 Nov 2015 | PLOS Medicine
10.1371/journal.pmed.1001907
Conclusions
The projected number of people receiving ART across three scenarios suggests that countries are unlikely to meet the 90-90-90 treatment target (81% of people living with HIV on ART by 2020) unless they adopt a test-and-offer approach and increase ART coverage. Our results suggest that future resource needs for ART scale-up are smaller than stated elsewhere but still significantly threaten the sustainability of the global HIV response without additional resource mobilization from domestic or innovative financing sources or efficiency gains. As the world moves towards adopting the WHO 2015 guidelines, advances in technology, including the introduction of lower-cost, highly effective antiretroviral regimens, whose value are assessed here, may prove to be “game changers” that allow more people to be on ART with the resources available.

Impact of the Neglected Tropical Diseases on Human Development in the Organisation of Islamic Cooperation Nations

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 28 November 2015)

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Impact of the Neglected Tropical Diseases on Human Development in the Organisation of Islamic Cooperation Nations
Peter J. Hotez, Jennifer R. Herricks
Editorial | published 25 Nov 2015 | PLOS Neglected Tropical Diseases
10.1371/journal.pntd.0003782
Extract
The employment of a new “worm index” of human development, together with additional published health information, confirms the important role neglected tropical diseases (NTDs) play in hindering the advancement of many of the world’s Muslim-majority countries.

The Organisation of Islamic Cooperation (OIC, previously the Organisation of the Islamic Conference) is the major inter-governmental organization of 57 Muslim-majority countries, with a mission to promote human rights (especially those of children, women, and the elderly), education, trade, and good governance (Fig 1) [1]. Under the OIC charter, the advancement of science and technology through cooperative research is also a key component [1,2]. In 2009, one of us (PJH) reviewed the available data on the major NTDs and found that many of these diseases disproportionately affected OIC countries, particularly the poorest nations of the Sahel and elsewhere in sub-Saharan Africa and Asia [3]. A previous survey of the 28 largest OIC nations—each with a population of at least 10 million people and comprising more than 90% of the populations of the OIC—found that they accounted for 35%–40% of the world’s soil-transmitted helminth infections and 46% of cases of schistosomiasis, in addition to approximately 20% of the cases of trachoma and leprosy [3]. Given the known impact of these NTDs on both public health and socioeconomic development, it was recommended that scale-up of mass treatment for these diseases should commence in the most affected OIC nations [3]. However, we find that it has been difficult to make progress against poverty and NTDs in the OIC nations…

Beyond Rational Decision-Making: Modelling the Influence of Cognitive Biases on the Dynamics of Vaccination Coverage

PLoS One
http://www.plosone.org/
[Accessed 28 November 2015]

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Beyond Rational Decision-Making: Modelling the Influence of Cognitive Biases on the Dynamics of Vaccination Coverage
Marina Voinson, Sylvain Billiard, Alexandra Alvergne
Research Article | published 23 Nov 2015 | PLOS ONE
10.1371/journal.pone.0142990
Abstract
Background
Theoretical studies predict that it is not possible to eradicate a disease under voluntary vaccination because of the emergence of non-vaccinating “free-riders” when vaccination coverage increases. A central tenet of this approach is that human behaviour follows an economic model of rational choice. Yet, empirical studies reveal that vaccination decisions do not necessarily maximize individual self-interest. Here we investigate the dynamics of vaccination coverage using an approach that dispenses with payoff maximization and assumes that risk perception results from the interaction between epidemiology and cognitive biases.
Methods
We consider a behaviour-incidence model in which individuals perceive actual epidemiological risks as a function of their opinion of vaccination. As a result of confirmation bias, sceptical individuals (negative opinion) overestimate infection cost while pro-vaccines individuals (positive opinion) overestimate vaccination cost. We considered a feedback between individuals and their environment as individuals could change their opinion, and thus the way they perceive risks, as a function of both the epidemiology and the most common opinion in the population.
Results
For all parameter values investigated, the infection is never eradicated under voluntary vaccination. For moderately contagious diseases, oscillations in vaccination coverage emerge because individuals process epidemiological information differently depending on their opinion. Conformism does not generate oscillations but slows down the cultural response to epidemiological change.
Conclusion
Failure to eradicate vaccine preventable disease emerges from the model because of cognitive biases that maintain heterogeneity in how people perceive risks. Thus, assumptions of economic rationality and payoff maximization are not mandatory for predicting commonly observed dynamics of vaccination coverage. This model shows that alternative notions of rationality, such as that of ecological rationality whereby individuals use simple cognitive heuristics, offer promising new avenues for modelling vaccination behaviour.

Building a Human Health Risk Assessment Ontology (RsO): A Proposed Framework

Risk Analysis
November 2015 Volume 35, Issue 11 Pages 1957–2119
http://onlinelibrary.wiley.com/doi/10.1111/risa.2015.35.issue-10/issuetoc

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Original Research Article
Building a Human Health Risk Assessment Ontology (RsO): A Proposed Framework
Thomas E. McKone1,2,* and Lydia Feng1
Article first published online: 15 MAY 2015
DOI: 10.1111/risa.12414
Abstract
Over the last decade the health and environmental research communities have made significant progress in collecting and improving access to genomic, toxicology, exposure, health, and disease data useful to health risk assessment. One of the barriers to applying these growing volumes of information in fields such as risk assessment is the lack of informatics tools to organize, curate, and evaluate thousands of journal publications and hundreds of databases to provide new insights on relationships among exposure, hazard, and disease burden. Many fields are developing ontologies as a way of organizing and analyzing large amounts of complex information from multiple scientific disciplines. Ontologies include a vocabulary of terms and concepts with defined logical relationships to each other. Building from the recently published exposure ontology and other relevant health and environmental ontologies, this article proposes an ontology for health risk assessment (RsO) that provides a structural framework for organizing risk assessment information and methods. The RsO is anchored by eight major concepts that were either identified by exploratory curations of the risk literature or the exposure-ontology working group as key for describing the risk assessment domain. These concepts are: (1) stressor, (2) receptor, (3) outcome, (4) exposure event, (5) dose-response approach, (6) dose-response metric, (7) uncertainty, and (8) measure of risk. We illustrate the utility of these concepts for the RsO with example curations of published risk assessments for ionizing radiation, arsenic in drinking water, and persistent pollutants in salmon.

Science – 27 November 2015

Science
27 November 2015 vol 350, issue 6264, pages 1001-1124
http://www.sciencemag.org/current.dtl

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Report
Predicting poverty and wealth from mobile phone metadata
Joshua Blumenstock1,*, Gabriel Cadamuro2, Robert On3
Author Affiliations
1Information School, University of Washington, Seattle, WA 98195, USA.
2Department of Computer Science and Engineering, University of Washington, Seattle, WA 98195, USA.
3School of Information, University of California, Berkeley, Berkeley, CA 94720, USA.
Abstract
Accurate and timely estimates of population characteristics are a critical input to social and economic research and policy. In industrialized economies, novel sources of data are enabling new approaches to demographic profiling, but in developing countries, fewer sources of big data exist. We show that an individual’s past history of mobile phone use can be used to infer his or her socioeconomic status. Furthermore, we demonstrate that the predicted attributes of millions of individuals can, in turn, accurately reconstruct the distribution of wealth of an entire nation or to infer the asset distribution of microregions composed of just a few households. In resource-constrained environments where censuses and household surveys are rare, this approach creates an option for gathering localized and timely information at a fraction of the cost of traditional methods.

Vaccine: Special Issue – Advancing Maternal Immunization Programs through Research in Low and Medium Income Countries

Vaccine
Volume 33, Issue 47, Pages 6371-6502 (25 November 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/46

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Advancing Maternal Immunization Programs through Research in Low and Medium Income Countries
Edited by M. Nesin, J. Read, M. Koso-Thomas, M. Brewinski Isaacs and A. Sobanjo-ter Meulen
[23 articles focused to the maternal immunization issue theme]

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Maternal Immunization: Current status and future prospects
Editorial
Page 6371
Mirjana Nesin, Jennifer Read, Marion Koso-Thomas, Maggie Brewinski Isaacs, Ajoke Sobanjo-ter Meulen
Overwhelming evidence demonstrates the benefits of vaccines to individuals (both children and adults) and to the public, primarily via herd immunity. The Global Vaccine Action Plan (GVAP), approved by the World Health Assembly in 2012, strives to ‘provide full benefits of vaccination to all people’, while Millennium Development Goals 4 and 5 work toward reduced child mortality and improved maternal health. Immunizing mothers during pregnancy (MI) against vaccine-preventable diseases has the potential to improve health outcomes in both mothers and their infants and to meet GVAP and Millennium Goals. MI may emerge as a key strategy to address neonatal mortality in particular, which accounts for almost half of all under five deaths globally.

Aside from the success of the Maternal and Neonatal Tetanus Elimination (MNTE) program, population data are now available for other successful MI programs, for example, in Argentina (described in this issue), and in the United Kingdom [1]. These programs have demonstrated the feasibility and effectiveness of MI programs in high, medium and low income counties. No safety signals related to the vaccines administered as part of these programs were observed.

An increasing amount of data regarding the efficacy and immunogenicity of MI in both mothers and their infants are becoming available. For example, studies have demonstrated the efficacy of influenza vaccines in protecting pregnant women and their infants, and the safety and effectiveness of maternal Tdap vaccination has been demonstrated in a large population of pregnant women [1], [2] and [3]. There is the potential for the results of ongoing trials of new RSV and GBS vaccines to contribute to the basis of licensure for a MI indication. An enabling regulatory and policy environment would facilitate introduction of new, and expanding indications of licensed, vaccines to include pregnant women.

However, major knowledge gaps and implementation challenges remain. They are related to the lack of descriptive epidemiologic data, especially in low and medium income countries (LMICs); the lack of harmonized definitions across studies, allowing meta-analyses and improved pharmacovigilance across studies and reporting systems; better understanding of infrastructure and experience with conducting clinical trials in LMICs settings; lack of integrated approaches to antenatal care, etc. The manuscripts included in this issue attempt to address some of these challenges: several studies describe the epidemiology of vaccine-preventable diseases (Polack et al., Halasa et al., Searle et al.); address harmonization of terms and definitions (Munoz et al.; Fulton et al.); provide perspective by researchers in LICs (Laufer et al., Cutland et al.); and describe regulatory (Gruber) and ethical (White and Madhi) aspects of MI.

Strong partnerships among a diverse set of institutions and geographies are needed to overcome knowledge gaps, implement studies, develop polices, and evaluate the efficacy and effectiveness of MI. A conference organized by NIH and BMGF in 2014 was a collaborative effort that brought together key global experts and stakeholders. Some authors of the manuscripts in this issue were presenters at the conference. The objectives of the conference and this special issue of Vaccine are to address knowledge gaps and identify approaches to move this important field forward worldwide.

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Maternal immunization – Promises and concerns
Pages 6372-6373
Janet A. Englund
Abstract
In this issue of Vaccine, the maternal immunization platform as an approach to protect mothers and infants against diverse pathogens is presented. Potential vaccine targets and the safety, science, trial designs, ethical considerations, and international perspectives focusing on low and middle income countries (LMIC) are discussed. This information provides a timely update because maternal immunization is increasingly being considered as an intervention to prevent maternal and/or neonatal disease. Prioritization of vaccine targets for maternal immunization by researchers, public health officials and health care workers needs to begin now.

Media/Policy Watch [to 28 November 2015]

Media/Policy Watch
This section is intended to alert readers to substantive news, analysis and opinion from the general media on vaccines, immunization, global; public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

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The Guardian
http://www.guardiannews.com/
Accessed 28 November 2015
Ebola overwhelmed the World Health Organisation: it must never happen again
26 November 2015
by Matshidiso Moeti, World Health Organisation’s regional director for Africa

At the World Health Organisation’s regional office for Africa, change is afoot across a number of key areas in an effort to prevent another Ebola-like crisis.

The Ebola outbreak in west Africa and its devastating toll on human life were stark reminders of the dangers posed by weak health systems. For the international community, the outbreak highlighted the importance of health security and epidemic preparedness, and demonstrated just how quickly local disease outbreaks can become global issues.

There is almost universal agreement that the international response to the outbreak was inadequate – it was too slow, too little and too late. All responders, including the World Health Organisation (WHO), were overwhelmed by the scale and devastation of the disease.

Fortunately, thanks to the herculean efforts of local and global partners, we have been largely able to halt this deadly epidemic. Yet there is evidence that the virus may persist for months in some survivors, leading to flare-ups of the disease, as occurred last week in Liberia.

Now is not the time for complacency; it is a moment for cautious optimism, reflection and action. The next outbreak, whatever and wherever it may be, could present new and even more complex challenges, and we must be prepared. This is not merely an option, it is a mandate.
At the WHO regional office for Africa (WHO Afro), we take our responsibility to deliver on this mandate very seriously. To prevent another crisis like the one we just experienced, we are changing the way we do business – quickly and substantively.

This week, we took a step in the right direction. At the 65th session of the WHO regional committee for Africa in N’Djamena, Chad, health ministers and senior officials from WHO Afro’s 47 member states endorsed a transformation agenda. This agenda will make WHO Afro the responsive, transparent and effective health agency the region needs and deserves.

Our reform efforts focus on four key areas. We will promote and instil shared values such as excellence, innovation, accountability and transparency. We will focus the technical work of the WHO secretariat on the region’s most important health problems, ensuring that evidence-based interventions are employed when and where they are most needed. We will build responsive strategic operations and strengthen management capacity to improve the way in which resources are matched to pressing health challenges. And we will enhance strategic partnerships and more effectively articulate and communicate our contribution to health development across the region.

These four focus areas are not just talking points. They will be measured and evaluated against a robust set of performance indicators, with rigorous monitoring and evaluation to gauge progress. They will be used to hold WHO Afro – and me – accountable to our most important stakeholders: Africa’s people.

In many ways, our transformation has already begun. Since February, we have been working to strengthen epidemic preparedness and response in 14 non-Ebola countries, resulting in the successful control of meningitis outbreaks in Niger, cholera among refugees in in the Tanzanian port town of Kigoma, and typhoid in Zambia. We’ve improved our collaboration with international partners, including the African Union commission, as we work toward the establishment of the African Centres for Disease Control. We’re working to grow Africa’s health research capacity, strengthen health systems and, ultimately, ensure universal health coverage.

These vital reforms come at a crucial moment. Just two months ago, the international community agreed a new framework, the sustainable development goals, designed to guide our collective efforts to build a better, healthier and more sustainable world over the next 15 years. While the African region has come a long way toward improving the health and wellbeing of its citizens, a renewed push is needed to fulfil the unfinished work of the millennium development goals and realise the promise of the this new agenda.

Guided by our transformation agenda, WHO Afro stands ready to lead in this new era. But we cannot do it alone. Achieving truly transformative change across the region will require support from governments, industry, civil society, academia and local communities. We must all step up and commit to achieving the sustainable development goals and building the Africa we want to leave behind for our children.

I am convinced that, by working together, we can and will bring health in the African region to a new level. The time to start is now.

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New York Times
http://www.nytimes.com/
Accessed 28 November 2015
Fixes
Amid Failure and Chaos, an Ebola Vaccine
By Tina Rosenberg
November 24, 2015 3:30 am
Excerpt
…The Ebola vaccine is a double achievement. Researchers proved the effectiveness not just of a novel vaccine, but also of a novel method of testing it rapidly, in chaotic conditions and without traditional clinical trials. Even as it was being tested, the vaccine was helping to contain Ebola. Today, hopes are high that it will administer the coup de grace to the epidemic.
How was this achieved? And what can the world learn that will save lives and money in fighting future outbreaks of Ebola or other pathogens?…

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Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 28 November 2015
Opinion
Commentary
A Post-Ebola Plan for Sierra Leone
We need reforms that will help us recover from this crisis and boost our resiliency against the next.
26 November 2015
By Ernest Bai Koroma, President of Sierra Leone.
Earlier this month, Sierra Leone was finally declared free of Ebola. The celebrations in Freetown and across the country were jubilant, but our victory was bittersweet. So many of our brothers and sisters lost their lives fighting this evil virus. Families were broken. Children were orphaned. Our communities were plagued by fear and the hopelessness that the situation may never improve.

Today, our understanding of what is needed for our country to recover is clearer than ever. The devastation caused by Ebola was symptomatic of wider problems. My government is not only focusing on rebuilding Sierra Leone but also on pre-empting future disasters. We are confident we will come back stronger than ever….

… I have an ambitious six-point plan for a better Sierra Leone: Instigate governance and system reform. Ebola caused socio-economic devastation, but the systems developed under this pressure serve as powerful examples of how to improve. These changes will stamp out corruption and encourage transparency for sustainable, Sierra Leonean-led development. Promote social cohesion, education and community mobilization. We need to develop programs and awareness campaigns that reinforce the reforms, working toward gaining the trust of the Sierra Leone people, increasing the legitimacy of government and harnessing the untapped human capital that will be a major safeguard against future crisis….

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Washington Post
http://www.washingtonpost.com/
Accessed 28 November 2015
Editorial Board | Editorial-Opinion | Nov 28, 2015
Everything went wrong in the Ebola outbreak. We’re still not ready if it happens again.
A report on the disaster underscores the risks of being ill-prepared.

ALMOST EVERYTHING that could go wrong did go wrong in the world’s early response to the outbreak of the Ebola virus in West Africa in 2014. Before it was over, the virus infected some 28,634 people and claimed more than 11,000 lives. It could happen again — and the world is still not ready.

Guinea had a weak health-care system when the virus took root in its remote regions, making it easier for the virus to spread to neighboring Liberia and Sierra Leone. Guinean authorities played down the seriousness for fear of creating panic and disrupting business. The World Health Organization declared the outbreak “relatively small still” in April 2014, and expert teams that had been sent in to the region were pulled out prematurely in May. WHO outbreak response teams had been “disproportionally” cut in a wave of headquarters layoffs. Margaret Chan, director general of the WHO, did not use her authority to declare a public-health emergency of international concern until five months after Guinea and Sierra Leone had notified the organization. Even after the emergency was declared, and a substantial global response was mobilized, “this response arrived late, was slow to deliver funds and health workers, was inflexible in adapting to rapidly changing conditions on the ground, was inadequately informed about cultural factors relevant to outbreak control, and was poorly coordinated,” according to a new study. “The result was, in essence, a $5 billion scramble.”

This is a sample of the findings contained in a report made public Nov. 22 by an independent panel of 19 experts who examined responses to the outbreak, particularly by the WHO, an agency of the United Nations. The report describes a cascade of failures and serves as a reminder that the existing methods of coping with infectious disease outbreaks are fragmented and fragile. The panel, launched by the Harvard Global Health Institute and the London School of Hygiene and Tropical Medicine, found that during the Ebola outbreak, the WHO fell down in all of its core functions: helping nations build up health-care capacity, providing early warning, establishing technical norms and mobilizing resources. The agency now faces an “existential crisis of confidence,” is “starved” of resources and “seems to have lost its way,” the experts write. “Confidence in the organization’s capacity to lead is at an all-time low.”

Before another bacterium or virus goes on a rampage, the panel recommends bolstering the WHO’s ability to respond quickly, including with a worldwide research and development fund for diagnostics, drugs and vaccines for diseases that have been neglected by the pharmaceutical industry. In many poor countries, basic health-care systems are still lacking, hampering their ability to fight outbreaks. It is also essential that governments give early warning of disease, regardless of the consequences. Response teams must take into account not only health and science concerns but also the beliefs, traditions, cultures and fears of local populations. The world fails to learn these lessons of Ebola at its peril.

Vaccines and Global Health: The Week in Review 21 November 2015

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

pdf version A pdf of the current issue is available here:  Vaccines and Global Health_The Week in Review_21 November 2015

blog edition: comprised of the approx. 35+ entries posted below on 23 November 2015.

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

Global Vaccine Action Plan -assessment report 2015

Global Vaccine Action Plan -assessment report 2015
Strategic Advisory Group of Experts on Immunization (SAGE) Decade of Vaccines Working Group
November 2015 :: 24 pages
English pdf, 278kb

EXECUTIVE SUMMARY [Text bolding from original]
The Global Vaccine Action Plan (GVAP) set ambitious but achievable goals, to save thousands of lives through vaccination in this Decade of Vaccines to 2020.

The Decade of Vaccines is not on course to achieve its true potential. Good progress has been made in some countries, including those where large numbers of unimmunized children live. These isolated improvements will have to become the norm if the plan is to get back on track.

In recommending what needs to change, this report focuses on two major problems that are holding back progress in the Decade of Vaccines:
:: The elimination strategies for maternal and neonatal tetanus, and for measles and rubella, and their implementation, are in urgent need of change and adequate resourcing.

:: The monitoring and accountability framework for the Global Vaccine Action Plan has gaps in its mechanisms for accountability, undermining the translation of the plan’s goals into reality.

At this critical midpoint of the Decade of Vaccines, SAGE makes nine recommendations, focusing squarely on the major issues.

To improve accountability to achieve the GVAP goals, SAGE recommends that:
1. Countries have annual plans for immunization consistent with the GVAP and relevant regional vaccine action plans. The Ministries of Health, Finance and other pertinent ministries demonstrate leadership by establishing an annual process for monitoring and accountability at national and subnational levels. Monitoring should be through an independent body, for example the National Immunization Technical Advisory Group (NITAG). Each country should share, every year, with WHO regional offices, its monitoring report which should include monitoring progress towards achievement of outcomes but also sharing of best practices.

2. Once regional vaccine action plans are finalised (by December 2015), WHO regional offices establish a process of annual progress review through their regional technical advisory groups and report to the respective Regional Committees. The first annual review should take place in the first half of 2016 for countries with annual plans consistent with the GVAP. WHO Regional Committees’ reports should be made available annually to SAGE as part of the global review process.

3. Global, regional and national development partners align their efforts to support countries in strengthening their leadership and accountability frameworks and in implementing their national plans. This should include establishing and/or strengthening partner coordination mechanisms at each level.

4. Decade of Vaccines secretariat agencies report to SAGE in 2016 on their supporting activities conducted in the 10 countries where most of the unvaccinated and under-vaccinated children live. This annual reporting mechanism should include discussion of those reports in regional technical advisory groups.

To address the shortfalls in disease-specific areas of the Global Vaccine Action Plan’s implementation, SAGE recommends that:
5. Given poor progress with elimination of maternal and neonatal tetanus and the relatively small funding gap to achieve this goal, WHO and UNICEF convene a meeting of global partners and the remaining 21 countries to agree on an action plan, resources and respective responsibilities so that the goal is achieved no later than 2017 and thereafter strategies are in place to sustain elimination in all countries.

6. Global, regional and national development partners support countries in securing the required resources and in implementing their measles and rubella elimination or control strategies and plans. The recommendations of the mid-term review of the global measles and rubella strategic plan to be conducted in 2016, once endorsed by SAGE, should be taken into account in refining plans and for monitoring and enhancing quality of plan implementation.

To improve immunization coverage especially where many unvaccinated and under-vaccinated children live, including those affected by conflict and crisis, SAGE recommends that:
7. Global, regional and country development partners coordinate and align their efforts to support countries to immunize more children by strengthening their healthcare delivery systems, combined with targeted approaches to reach children consistently missed by the routine delivery system, particularly in the countries where vaccination rates are below 80% and to provide services to populations displaced due to conflict (both internally displaced persons and refugees).

8. WHO provide guidance for countries and partners on implementation of immunization programmes and immunization strategies during situations of conflict and chronic disruption.

The 2016 GVAP assessment report will also serve as a mid-term review of progress in the Decade of Vaccines and SAGE recommends that:
9. This report be presented at the World Economic Forum in Davos where the Decade of Vaccines was launched. The 2016 report should aim to highlight those activities that were game-changers at global, regional and country levels.

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Decade of Vaccines Global Vaccine Action Plan GVAP Secretariat report 2015
Update actions on taken by the secretariat in response to previous reports
Dr Thomas Cherian on behalf of the DoV GVAP Secretariat
SAGE, Geneva, 22nd October 2015
[PowerPoint from SAGE Meeting, October 2015]

EBOLA/EVD [to 21 November 2015]

EBOLA/EVD [to 21 November 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

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Ebola Situation Report – 18 November 2015
[Excerpt]
SUMMARY
:: Guinea reported no confirmed cases of Ebola virus disease (EVD) in the week to 15 November. The most recent case from Guinea was reported on 29 October. That case is a child who was born in an Ebola treatment centre, and who was delivered by medical staff wearing full personal protective equipment (PPE). As such, no contacts are associated with this case, and all contacts associated with previous cases have completed their 21-day follow-up period. A second consecutive blood sample from the child tested negative for Ebola virus on 16 November.
:: On 7 November WHO declared that Ebola virus transmission had been stopped in Sierra Leone. The country has now entered a 90-day period of enhanced surveillance, which is scheduled to conclude on 5 February 2016. Both Liberia and Sierra Leone have now achieved objective 1 of the phase 3 response framework: to interrupt all remaining chains of Ebola virus transmission…

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New Ebola cases hit Liberia after country declared virus free
Reuters – Health | Fri Nov 20, 2015 3:10pm EST
MONROVIA | By James Harding Giahyue
Three new cases of Ebola emerged in Liberia on Friday, a setback for a country that had been declared free of the disease on September 3 and also a blow for the wider region as it struggles to end an epidemic that has killed around 11,300 people.

The first of the new patients was a 10-year-old boy who lived with his parents and three siblings in Paynesville, a suburb east of the capital Monrovia, said Minister of Health Minister Bernice Dahn. Two direct family members have also since tested positive, officials said.

All six family members, as well as other high risk contacts, are in care at an Ebola Treatment Unit in Paynesville, she said.

“The hospital is currently decontaminating the unit. All of the healthcare workers who came into contact with the patient have been notified,” she told a news conference.

“We know how Ebola spreads and we know how to stop Ebola but we must remain vigilant and work together,” she said.

Bruce Aylward, who leads the Ebola response for the U.N. World Health Organisation, said the patient had no history of contact with an Ebola survivor or victim.

“The family obviously is at particular risk and is being investigated right now,” he told a news conference in Geneva, speaking before confirmation that two of the first patient’s siblings had also tested positive.

Liberia has seen more than 10,600 cases of the disease and 4,808 Ebola deaths since it was first announced in March, 2014, WHO figures show…

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Dr. David Nabarro (Special Envoy of the Secretary-General on Ebola) on Ebola – Press Conference (18 November 2015) (English)
18 Nov 2015
Video – 00:37:45
Dr. David Nabarro, the Special Envoy on Ebola, providing an update on the Ebola outbreak, and also speaking in his capacity as Chair of the Advisory Group on Reform of the World Health Organization’s Work in Outbreaks and Emergencies.

First report of the Advisory Group on Reform of WHO’s work in outbreaks and emergencies

Advisory Group on Reform of WHO’s Work in Outbreaks and Emergencies with Health and Humanitarian Consequences
http://www.who.int/about/who_reform/emergency-capacities/advisory-group/en/

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First report of the Advisory Group on Reform of WHO’s work in outbreaks and emergencies pdf, 659kb
15 November 2015
[Advance version highlighted in last week’s edition]

POLIO [to 21 November 2015]

POLIO [to 21 November 2015]
Public Health Emergency of International Concern (PHEIC)

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GPEI Update: Polio this week as of 17 November 2015
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: In 2015, wild poliovirus transmission is at the lowest levels ever, with fewer cases reported from fewer areas of fewer countries than ever before. In 2015, 56 wild poliovirus cases have been reported from two countries (Pakistan and Afghanistan), compared to 290 cases from nine countries during the same period in 2014.

:: However, in the end stages of polio eradication, with most of the world polio-free, the risks posed remaining vaccination coverage gaps anywhere is becoming more evident. On extremely rare occasions, in areas of chronic vaccination coverage gaps, circulating vaccine-derived polioviruses (cVDPVs) can emerge to cause outbreaks of polio cases. This is not a side effect of the oral polio vaccine, but rather an effect of low vaccination coverage in a community, which is enabling such strains to emerge. Though typically less virulent than wild polioviruses (ie typically causing fewer cases and having a lower profile for geographic spread), such strains nevertheless are this year causing paralysis in children at a rate greater than wild polioviruses. More countries are affected by cVDPV outbreaks (Ukraine, Guinea, Lao, Nigeria, Madagascar) than wild polioviruses (Pakistan and Afghanistan); 3 WHO Regions are affected by cVDPV outbreaks.

:: Efforts are ongoing by the Global Polio Eradication Initiative to urgently address both remaining wild poliovirus transmission and cVDPV outbreaks. This is particularly important in the lead-up to next year’s start of the phased removal of OPVs, beginning with the globally-coordinated switch from trivalent OPV to bivalent OPV in April 2016.

[Selected elements from Country-level reports]
Afghanistan
:: Three new wild poliovirus type 1 (WPV1) cases were reported in the past week, from Faryab and Nangahar provinces. The most recent case had onset of paralysis on 27 October, from Nangahar. The total number of WPV1 cases for 2015 is 16.
:: One new WPV1 environmental positive sample was reported in the past week, collected on 25 October from Wardad.
:: Urgent efforts are underway to strengthen the implementation of the national emergency action plan in the country. Focus is on:
– Improving governance and coordination of partners through the National and Provincial Emergency Operations Centres
– Improving SIA quality by focusing resources on low-performing districts, and clearly identifying and targeting persistently missed children
– Maximising the impact of front-line health workers through more systematic vaccinator selection, training and supervision
– Ensuring closer cross-border coordination in border areas with Pakistan
– Further strengthening surveillance, including by expanding environmental surveillance activities
:: National Immunization Days (NIDs) took place on 1 – 3 November using trivalent oral polio vaccine (OPV). Mop up campaigns are planned in areas of Farah using inactivated polio vaccine (IPV) and bivalent OPV with dates to be confirmed, and Subnational Immunisation Days (SNIDs) are planned from 29 November to 1 December in the south and east of the country using bivalent OPV.
Pakistan
:: One new wild poliovirus type 1 (WPV1) case was reported in the past week, with onset of paralysis on 22 October. It is the most recent WPV1 case in the country, from Peshawar in Federally Administered Tribal Areas (FATA). The total number of WPV1 cases for 2015 is 40.
:: Two new type 2 circulating vaccine-derived poliovirus (cVDPV2) cases were retrospectively reported this week. The cases had onset of paralysis in February, from Khyber Paktunkhwa and FATA. No further cases have been identified since then, and the areas were covered by three vaccination campaigns with trivalent OPV.
:: One new environmental sample positive for WPV1 was reported in the last week, from Gadap, greater Karachi, Sindh, collected on 13 October.
:: September and October have historically been the months with the highest disease burden, as it is in the middle of the high transmission season. Epidemiologists are further evaluating data from this year, to more clearly ascertain current transmission patterns during this year’s high transmission season. This year, six WPV1 cases were reported during September and October, compared to 79 WPV1 cases in September/October 2014.

WHO & Regionals [to 21 November 2015]

WHO & Regionals [to 21 November 2015]

WHO calls on countries to protect health from climate change
WHO statement
17 November 2015
Climate change is the defining issue for the 21st century.
According to WHO estimates, climate change is already causing tens of thousands of deaths every year – from shifting patterns of disease, from extreme weather events, such as heat-waves and floods, and from the degradation of air quality, food and water supplies, and sanitation.
The upcoming United Nations Climate Change Conference (COP-21) in Paris offers the world an important opportunity to not only reach a strong international climate agreement, but also to protect the health of current and future generations. WHO considers the Paris treaty to be a significant public health treaty – one that has the potential to save lives worldwide…

15 million babies are born prematurely every year
Complications of preterm births are the leading cause of death among children under 5 years of age. Without appropriate treatment, those who survive often face lifelong disabilities, including learning, visual and hearing problems and their quality of life is greatly affected.

Physical inactivity and diabetes
November 2015 — Worldwide, people are less physically active. As physical activity decreases, noncommunicable diseases like diabetes are increasing. In the WHO European Region, one third of adults and two thirds of adolescents are insufficiently active.

Clean water and building toilets improves nutrition in Mali
19 November 2015 — WHO, in collaboration with USAID and UNICEF, are calling for nutrition and water, sanitation and hygiene programmes to work together to maximize nutrition gains. A new report recommends high-impact solutions such as improving access to latrines. Mali has already started implementing some of these recommendations with great success.

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Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: 20 November 2015 Microcephaly – Brazil
:: 16 November 2015 Acute respiratory syndrome – Republic of Korea

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Weekly Epidemiological Record (WER) 20 November 2015, vol. 90, 47 (pp. 633–644)
Contents
633 Preparedness for outbreaks of meningococcal meningitis due to Neisseria meningitidis serogroup C in Africa: recommendations from a WHO expert consultation
637 Progress towards poliomyelitis eradication: Pakistan, January 2014–September 2015
643 Monthly report on dracunculiasis cases, January- September 2015

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Request for proposals: GAVI transition support consultant
20 November 2015
Terms of reference pdf, 128kb
Deadline for application: 9 December 2015

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:: WHO Regional Offices
WHO African Region AFRO
:: Dr Moeti lauds health development efforts in Chad
N’Djamena, 19 November 2015 – The World Health Organization Regional Director for Africa, Dr. Matshidiso Moeti, has commended ongoing efforts in Chad to improve the health and wellbeing of the people. Dr Moeti made the remarks during a courtesy call on the Chadian Prime Minister Kalzeubé Payimi Deubet.During the meeting, the Regional Director observed that the priority that the Chadian government has placed on health is making a difference despite the prevailing challenges. Since 2012 Chad has drastically reduced the occurrences of meningitis and cholera outbreaks. Polio transmission has been stopped as well. Furthermore maternal deaths have been reduced from…

WHO Region of the Americas PAHO
:: PAHO to update its manuals on management of obstetric emergencies (11/18/2015)
:: Antibiotics should be ‘handled with care’ to preserve their life-saving qualities (11/18/2015)
:: MERCOSUR countries create a negotiating mechanism to procure high-cost medicines, with PAHO support (11/16/2015)

WHO South-East Asia Region SEARO
:: Antibiotics, handle with care 16 November 2015

WHO European Region EURO
:: Addressing the largest single cause of preventable deaths in Europe – cardiovascular disease 19-11-2015
:: Efforts must be scaled up in order to halve road traffic deaths by 2020 19-11-2015
:: New WHO report shows comparable antibiotic resistance in EU and non-EU countries in the European Region 16-11-2015

WHO Eastern Mediterranean Region EMRO
:: Launch of first World Antibiotics Awareness Week from 16 to 22 November 2015

WHO Western Pacific Region
:: World Health Organization launches World Antibiotic Awareness Week to promote best practices in the Western Pacific Region
MANILA, 16 November 2015

Sabin Vaccine Institute [to 21 November 2015]

Sabin Vaccine Institute [to 21 November 2015]
http://www.sabin.org/updates/pressreleases

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Sabin PDP, King Saud University Sign Project Agreement to Build Vaccine Research and Development Capacity in Saudi Arabia
New Initiative Will Focus on Public Health Preparedness for Emerging, Neglected Diseases
WASHINGTON, D.C. — November 16, 2015 — The Sabin Vaccine Institute Product Development Partnership (Sabin PDP) today signed a project agreement with King Saud University to build vaccine research and development capacity in the Middle East and North Africa (MENA) region and advance the establishment of a vaccine research institute in Saudi Arabia. The project will focus on training activities that could lead to vaccine development for major and emerging neglected diseases and parasitic infections in the region.
As part of this U.S.-Saudi initiative, Saudi scientists, including students and faculty, from Prince Naif Bin Abdulaziz Health Research Center at King Saud University in Riyadh, and other Saudi institutions, will receive technical training in vaccine development processes at the Sabin PDP laboratories, in Houston, Texas. Both partners will work to build the necessary workforce needed for vaccine process development and scale-up, in Saudi Arabia while also developing a total quality management system, including quality control and quality assurance…

Global Fund [to 21 November 2015]

Global Fund [to 21 November 2015]
http://www.theglobalfund.org/en/news/

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New Grant to Support Human Rights in 10 African Countries
19 November 2015
GENEVA – The United Nations Development Programme (UNDP) and the Global Fund have signed a US$10.5 million grant to address human rights barriers faced by vulnerable communities in Africa, and facilitate access to lifesaving health care. The grant is the first of its kind and will cover 10 countries including Botswana, Côte d’Ivoire, Kenya, Malawi, Nigeria, Senegal, the Seychelles, Tanzania, Uganda and Zambia.

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Global Fund Board Approves New Strategic Framework
17 November 2015
GENEVA – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria approved a new framework for its 2017-2022 strategy to maximize impact, strengthen systems for health, promote and protect human rights and gender equality, and mobilize additional resources.

IAVI International AIDS Vaccine Initiative [to 21 November 2015]

IAVI International AIDS Vaccine Initiative [to 21 November 2015]
http://www.iavi.org/press-releases/2015

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Francine Ntoumi Joins IAVI Board of Directors
November 17, 2015
The International AIDS Vaccine Initiative (IAVI) is pleased to announce that Francine Ntoumi, Founder, Chair and Executive Director of the Congolese Foundation for Medical Research, has joined its Board of Directors.

“We are very pleased to welcome Dr. Ntoumi to IAVI’s Board,” said IAVI Board Chair Alex Coutinho. “Her pioneering work in infection research and her dedication to advancing African scientific capacity align perfectly with key pillars of IAVI’s work toward a safe, effective AIDS vaccine.”…

European Medicines Agency [to 21 November 2015]

European Medicines Agency [to 21 November 2015]
http://www.ema.europa.eu/

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20/11/2015
HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS
Reports after HPV vaccination consistent with what would be expected in this age group…

17/11/2015
New strategy to fight antimicrobial resistance
EMA veterinary committee sets objectives to limit risks arising from use of antimicrobials in animals…

16/11/2015
Guido Rasi takes office as head of EMA
Executive Director appointed for five-year term…

EDCTP [to 21 November 2015]

EDCTP [to 21 November 2015]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials.

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Grantees selected to build Ebola research capacity
6 November 2015
Six institutions in Africa and Europe have been awarded funding to strengthen capacity in sub-Saharan Africa to conduct high quality health research during health emergencies and/or epidemic outbreaks. The grants were developed in response to the Ebola virus disease (EVD) outbreak in West Africa, and they address individual, institutional, national and regional capacity.

Three recipients are based in Africa and three are in Europe, working in Africa and with African partners. The scope of the projects ranges from enhancing capacity for clinical trials to health system rebuilding. The European & Developing Countries Clinical Trials Partnership (EDCTP) and TDR are providing the €1.49 million funding…

MSF/Médecins Sans Frontières [to 21 November 2015]

MSF/Médecins Sans Frontières [to 21 November 2015]
http://www.doctorswithoutborders.org/news-stories/press/press-releases

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MSF Launches Global Action Against Pfizer and GlaxoSmithKline to Cut the Price of Pneumonia Vaccine
November 12, 2015
[Excerpt from press release]
New York—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) launched a global petition today, World Pneumonia Day, calling on pharmaceutical companies Pfizer and GlaxoSmithKline (GSK) to reduce the price for humanitarian organizations…

IVI Launches Online Campaign in Collaboration with Naver, Korea’s Largest Internet Portal

IVI [to 21 November 2015]
http://www.ivi.org/web/www/home

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IVI Launches Online Campaign in Collaboration with Naver, Korea’s Largest Internet Portal
2015.11.20
IVI is pleased to announce the kick-off of its online campaign today in collaboration with Naver, Korea’s largest Internet portal. The title of the Korean-language campaign, roughly translated as “Vaccine, one drop that saves lives” will be broadcast on Naver’s Happybean, a popular online donation portal with an average of 4.2 million monthly visitors. The month-long campaign aims to raise awareness about IVI and our work among the Korean public and to mobilize support for our vaccine initiatives to protect children from deadly infectious diseases such as cholera, typhoid, and dengue. Highlighted in our campaign is our combat against cholera in Nepal, a country still grappling with public health issues after the devastating earthquakes in April. More than 300,000 people in Nepal are at risk for cholera.

For every child, a fair chance: The promise of equity – UNICEF Report

UNICEF [to 21 November 2015]
http://www.unicef.org/media/media_78364.html

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For every child, a fair chance: The promise of equity
UNICEF
November 2015 :: 48 pages :: ISBN: 978-92-806-4817-1
PDF: http://www.unicef.org/media/files/Equity_Report.pdf

Introduction: The equity agenda
Giving a fair chance in life to every child, everywhere – especially the most disadvantaged – offers the greatest hope of breaking intergenerational cycles of inequity and poverty in every society. That is the central proposition underlying UNICEF’s ‘equity agenda’.

The principle of equity guides UNICEF’s work with a sharp focus on the world’s most vulnerable children: those from the poorest households, girls, children with disabilities, migrant and refugee children, those living in remote areas, and children from ethnic or religious groups facing discrimination. The following pages build on evidence and experience from this work to make two main arguments for closing persistent gaps in equity.

First, the cycle of inequity is neither inevitable nor insurmountable. UNICEF works to break that cycle by tackling inequities in opportunity for children who have been marginalized. That means supporting interventions to give these children a good start in life and continuing to intervene at key points during their early childhood and adolescence. Making such investments not only changes the future of the most disadvantaged children but also charts a new course for their children.

Second, the cost of inaction is too high. Failing to invest sustainably in essential services and protection for every child does not just deny today’s children their rights but will have detrimental effects for generations to come. Failing to seize critical windows of opportunity in the lives of the most vulnerable children now will incur higher costs later. These costs will be felt in terms of lost lives, wasted potential and reduced productivity. In the end, inaction will contribute to social and economic inequities affecting entire societies and will slow or reverse global development progress.

This report outlines many of the milestones achieved for the world’s poor and marginalized children to date, as well as many of the remaining gaps. It examines seven sectors that are critical to progress for children: health; HIV and AIDS; water, sanitation and hygiene; nutrition; education; child protection; and social inclusion. In each sector, there are stark contrasts between global advances on one hand and the urgent, unmet needs of the world’s most vulnerable children on the other.

Beyond facts and figures, the report also features selected stories about children and families who have not shared equally in those advances – and about what UNICEF and its partners are doing to right the balance. The stories highlight equity-focused approaches to both humanitarian crises and longer-term development, because action on both fronts will be needed to achieve the newly adopted Sustainable Development Goals.

As policymakers chart pathways for the post-2015 era, the time has come to invest sustainably in equity for the most disadvantaged. For every child, a fair chance sets out UNICEF’s vision for equity and demonstrates the positive, concrete impact of equity-based programmes. Above all, the report underscores why equity is so important: because all children have the right to survive, thrive and reach their full potential, whoever they are and wherever they live.

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Press release
Universal Children’s Day: Why fair matters
NEW YORK, 20 November 2015 – The world remains a deeply unfair place for the poorest and most disadvantaged children despite major advances since the adoption of the Convention on the Rights of the Child in 1989, according to a UNICEF report released today.

“In just over a generation, the world has cut child death rates by half, put over 90 per cent of children in primary school, and increased by 2.6 billion the number of people with access to safe water,” said UNICEF Executive Director Anthony Lake.

“Yet children make up almost half of the world’s poor, nearly 250 million children live in conflict-torn countries, and over 200,000 have risked their lives this year seeking refuge in Europe.”
The report, For every child, a fair chance: The promise of equity, presents a statistical picture of how the world’s most marginalized children have fared against basic human development indicators.

It points out that:
:: Children from the poorest households are nearly twice as likely as those from the richest households to die before age five, and five times more likely to be out of school.
:: Girls from the poorest families are four times more likely as those from the richest families to be married before 18.
:: More than 2.4 billion people still do not have adequate toilets – 40 per cent of them in South Asia; and more than 660 million still lack access to safe drinking water – nearly half of them in sub-Saharan Africa.
:: Roughly half of the 159 million children suffering from stunting live in South Asia and one-third in Africa.

“Such vast inequities fuel a vicious intergenerational cycle of poverty and disadvantage,” Lake said. “But it doesn’t have to be this way. We know how to slow, stop, and reverse it into a virtuous cycle of intergenerational progress. It is up to us to decide to do so through more commitment and resources. We must make this moral, pragmatic, strategic…and fair…choice.”

For every child, a fair chance makes the case for closing persistent gaps in equity, arguing that investing in children, particularly the most vulnerable, is right in principle and right in practice – and that such investment brings multiple benefits not only to children but also to their families, communities and economies…

American Journal of Public Health – Volume 105, Issue 12 (December 2015)

American Journal of Public Health
Volume 105, Issue 12 (December 2015)
http://ajph.aphapublications.org/toc/ajph/current

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EDITOR’S CHOICE
Preserving the Social Contract of Health Care—A Call to Action
Kumaran Senthil, Evan Russell, Hannah Lantos
American Journal of Public Health: December 2015, Vol. 105, No. 12: 2404–2404.
[No abstract]

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EDITORIALS
Middle East Refugees The Refugee Crisis in the Middle East and Public Health
Alfredo Morabia, Georges C. Benjamin
American Journal of Public Health: December 2015, Vol. 105, No. 12: 2405–2406.

Syrian and Iraqi Refugees: A Palestinian Perspective
Rita Giacaman
American Journal of Public Health: December 2015, Vol. 105, No. 12: 2406–2407.

Let’s Not Forget the Health of the Syrians Within Their Own Country
Hyam Bashour
American Journal of Public Health: December 2015, Vol. 105, No. 12: 2407–2408.

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RESEARCH AND PRACTICE
Human Papillomavirus Predictors of Human Papillomavirus Vaccine Completion Among Female and Male Vaccine Initiators in Family Planning Centers
Hannah R. Simons, Zoe D. Unger, Priscilla M. Lopez, Julia E. Kohn
American Journal of Public Health: December 2015, Vol. 105, No. 12: 2541–2548.
Abstract
Objectives. We estimated human papillomavirus (HPV) vaccine series completion and examined predictors of completion among adolescents and young adults in a large family planning network.
Methods. Our retrospective cohort study of vaccine completion within 12 months and time to completion used electronic health record data from 119 Planned Parenthood health centers in 11 US states for 9648 patients who initiated HPV vaccination between January 2011 and January 2013.
Results. Among vaccine initiators, 29% completed the series within 12 months. Patients who were male, younger than 22 years, or non-Hispanic Black or who had public insurance were less likely to complete within 12 months and completed more slowly than their counterparts. Gender appeared to modify the effect of public versus private insurance on completion (adjusted hazard ratio = 0.76 for women and 0.95 for men; relative excess risk due to interaction = 0.41; 95% confidence interval = 0.09, 0.73).
Conclusions. Completion was low yet similar to previous studies conducted in safety net settings.

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Quadrivalent Human Papillomavirus Vaccine Initiation in Boys Before and Since Routine Use: Southern California, 2009–2013
Rulin C. Hechter, Chun R. Chao, Margo A. Sidell, Lina S. Sy, Bradley K. Ackerson, Jeff M. Slezak, Nilesh J. Patel, Hung Fu Tseng, Steven J. Jacobsen
American Journal of Public Health: December 2015, Vol. 105, No. 12: 2549–2556.
Abstract
Objectives. We examined the trends and correlates of quadrivalent human papillomavirus vaccine (HPV4) initiation in insured boys during the periods before and after routine use recommendation.
Methods. We grouped data from electronic medical records of boys aged 9 to 17 years from the Kaiser Permanente Southern California prepaid health plan into 3 open cohorts: permissive use: 2009 to 2010; anal cancer indication added: 2010 to 2011; and routine use: 2011 to 2013. We estimated adjusted risk ratios (ARRs) between demographics and vaccination initiation using Poisson regression.
Results. HPV4 initiation increased across cohorts—1.6%, 3.4%, and 18.5%—with the greatest increase among boys aged 11 to 12 years in cohort 3. Initiation was associated with receiving influenza vaccination in the previous year in all cohorts (cohort 3: ARR = 1.48; 95% confidence interval [CI] = 1.46, 1.51) and with non-White race/ethnicity following routine recommendation (cohort 3, non-Hispanic Black: ARR = 1.18; 95% CI = 1.08, 1.30; Hispanic: ARR = 1.23; 95% CI = 1.17, 1.29; Asian/Pacific Islanders: ARR = 1.16; 95% CI = 1.11, 1.20).
Conclusions. Routine use recommendation increased the uptake of HPV4 in boys. System-level interventions to encourage providers to routinely recommend HPV4 vaccination may help increase HPV4 uptake in boys.

Microbiological Contamination of Drinking Water Associated with Subsequent Child Diarrhea

American Journal of Tropical Medicine and Hygiene
November 2015; 93 (5)
http://www.ajtmh.org/content/current

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Editorial
Does Poor Water Quality Cause Diarrheal Disease?
Karen Levy
Am J Trop Med Hyg 2015 93:899-900; Published online October 5, 2015, doi:10.4269/ajtmh.15-0689
Full Text

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Articles
Microbiological Contamination of Drinking Water Associated with Subsequent Child Diarrhea
Stephen P. Luby, Amal K. Halder, Tarique Md. Huda, Leanne Unicomb, M. Sirajul Islam,
Benjamin F. Arnold, and Richard B. Johnston
Am J Trop Med Hyg 2015 93:904-911; Published online October 5, 2015, doi:10.4269/ajtmh.15-0274
OPEN ACCESS ARTICLE

BMC Health Services Research (Accessed 21 November 2015)

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 21 November 2015)

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Research article
Improving access to medicines through centralised dispensing in the public sector: a case study of the Chronic Dispensing Unit in the Western Cape Province, South Africa
Bvudzai Magadzire, Bruno Marchal, Kim Ward
BMC Health Services Research 2015, 15:513 (17 November 2015)

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Research article
Cost effectiveness analysis of Year 2 of an elementary school-located influenza vaccination program–Results from a randomized controlled trial
Byung-Kwang Yoo, Sharon Humiston, Peter Szilagyi, Stanley Schaffer, Christine Long, Maureen Kolasa
BMC Health Services Research 2015, 15:511 (16 November 2015)
Abstract
Background
School-located vaccination against influenza (SLV-I) has the potential to improve current suboptimal influenza immunization coverage for U.S. school-aged children. However, little is known about SLV-I’s cost-effectiveness. The objective of this study is to establish the cost-effectiveness of SLV-I based on a two-year community-based randomized controlled trial (Year 1: 2009–2010 vaccination season, an unusual H1N1 pandemic influenza season, and Year 2: 2010–2011, a more typical influenza season).
Methods
We performed a cost-effectiveness analysis on a two-year randomized controlled trial of a Western New York SLV-I program. SLV-I clinics were offered in 21 intervention elementary schools (Year 1 n = 9,027; Year 2 n = 9,145 children) with standard-of-care (no SLV-I) in control schools (Year 1 n = 4,534 (10 schools); Year 2 n = 4,796 children (11 schools)). We estimated the cost-per-vaccinated child, by dividing the incremental cost of the intervention by the incremental effectiveness (i.e., the number of additionally vaccinated students in intervention schools compared to control schools).
Results
In Years 1 and 2, respectively, the effectiveness measure (proportion of children vaccinated) was 11.2 and 12.0 percentage points higher in intervention (40.7 % and 40.4 %) than control schools. In year 2, the cost-per-vaccinated child excluding vaccine purchase ($59.88 in 2010 US $) consisted of three component costs: (A) the school costs ($8.25); (B) the project coordination costs ($32.33); and (C) the vendor costs excluding vaccine purchase ($16.68), summed through Monte Carlo simulation. Compared to Year 1, the two component costs (A) and (C) decreased, while the component cost (B) increased in Year 2. The cost-per-vaccinated child, excluding vaccine purchase, was $59.73 (Year 1) and $59.88 (Year 2, statistically indistinguishable from Year 1), higher than the published cost of providing influenza vaccination in medical practices ($39.54). However, taking indirect costs (e.g., averted parental costs to visit medical practices) into account, vaccination was less costly in SLV-I ($23.96 in Year 1, $24.07 in Year 2) than in medical practices.
Conclusions
Our two-year trial’s findings reinforced the evidence to support SLV-I as a potentially favorable system to increase childhood influenza vaccination rates in a cost-efficient way. Increased efficiencies in SLV-I are needed for a sustainable and scalable SLV-I program.

Comparison of registered and published outcomes in randomized controlled trials: a systematic review

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 21 November 2015)

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Research article
Comparison of registered and published outcomes in randomized controlled trials: a systematic review
Christopher Jones, Lukas Keil, Wesley Holland, Melissa Caughey, Timothy Platts-Mills BMC Medicine 2015, 13:282 (18 November 2015)
Abstract
Background
Clinical trial registries can improve the validity of trial results by facilitating comparisons between prospectively planned and reported outcomes. Previous reports on the frequency of planned and reported outcome inconsistencies have reported widely discrepant results. It is unknown whether these discrepancies are due to differences between the included trials, or to methodological differences between studies. We aimed to systematically review the prevalence and nature of discrepancies between registered and published outcomes among clinical trials.
Methods
We searched MEDLINE via PubMed, EMBASE, and CINAHL, and checked references of included publications to identify studies that compared trial outcomes as documented in a publicly accessible clinical trials registry with published trial outcomes. Two authors independently selected eligible studies and performed data extraction. We present summary data rather than pooled analyses owing to methodological heterogeneity among the included studies.
Results
Twenty-seven studies were eligible for inclusion. The overall risk of bias among included studies was moderate to high. These studies assessed outcome agreement for a median of 65 individual trials (interquartile range [IQR] 25–110). The median proportion of trials with an identified discrepancy between the registered and published primary outcome was 31 %; substantial variability in the prevalence of these primary outcome discrepancies was observed among the included studies (range 0 % (0/66) to 100 % (1/1), IQR 17–45 %). We found less variability within the subset of studies that assessed the agreement between prospectively registered outcomes and published outcomes, among which the median observed discrepancy rate was 41 % (range 30 % (13/43) to 100 % (1/1), IQR 33–48 %). The nature of observed primary outcome discrepancies also varied substantially between included studies. Among the studies providing detailed descriptions of these outcome discrepancies, a median of 13 % of trials introduced a new, unregistered outcome in the published manuscript (IQR 5–16 %).
Conclusions
Discrepancies between registered and published outcomes of clinical trials are common regardless of funding mechanism or the journals in which they are published. Consistent reporting of prospectively defined outcomes and consistent utilization of registry data during the peer review process may improve the validity of clinical trial publications

Perceptions and plans for prevention of Ebola: results from a national survey

BMC Public Health
http://www.biomedcentral.com/bmcpublichealth/content
(Accessed 21 November 2015)

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Research article
Perceptions and plans for prevention of Ebola: results from a national survey
Bridget Kelly, Linda Squiers, Carla Bann, Alexander Stine, Heather Hansen, Molly Lynch BMC Public Health 2015, 15:1136 (16 November 2015)
Abstract
Background
Literature suggests that Americans may have higher levels of perceived threat to Ebola than are warranted.
Methods
We surveyed 1018 U.S. adults from a nationally representative Internet panel about their knowledge, perceived threat, and behavioral intentions during the 2014 Ebola outbreak.
Results
Eighty-six percent of respondents knew that Ebola could be transmitted through blood and bodily fluids. However, a large percentage had some inaccurate knowledge and 19 % believed Ebola would spread to the U.S. Respondents favored mandatory quarantine (63 %) and travel bans (55 %). Confidence in the ability of the media and government to accurately report on or prevent a U.S. epidemic was low. Fifty-two percent intended to engage in behaviors such as avoiding public transportation.
Discussion
Despite low perceived susceptibility, half intended to engage in behaviors to prevent transmission and large numbers favored policies not currently recommended by health officials. The extreme nature of Ebola virus likely motivated people to engage in behaviors and favor policies that were not necessary given the low risk of transmission in the U.S.
Conclusions
Health officials should ensure the public has accurate information about Ebola and bolster confidence in the government’s ability to control infectious diseases in case of a future outbreak in the U.S.

Maternal vaccination against H1N1 influenza and offspring mortality: population based cohort study and sibling design

British Medical Journal
21 November 2015 (vol 351, issue 8034)
http://www.bmj.com/content/351/8034

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Maternal vaccination against H1N1 influenza and offspring mortality: population based cohort study and sibling design
BMJ 2015; 351 :h5585 (Published 16 November 2015)
Abstract
Study question
What is the mortality in offspring of mothers who had influenza A(H1N1)pdm09 vaccination during pregnancy?
Methods
This was a prospective population based cohort study in seven healthcare regions in Sweden based on vaccinations taking place between 2 October 2009 and 26 November 2010. H1N1 vaccination data were linked with pregnancy and birth characteristics and offspring mortality data in 275 500 births (of which 1203 were stillbirths) from 137 886 mothers. Of these offspring, 41 183 had been exposed to vaccination with Pandemrix, a monovalent AS03 adjuvanted H1N1 influenza vaccine, during fetal life. A primary comparison group consisted of pregnancies of women who were not vaccinated during the same calendar period. In a second comparison, non-exposed siblings of infants prenatally exposed to vaccination were used as controls. Cox regression was used to estimate hazard ratios for stillbirth, early neonatal mortality (days 0-6 after birth), and subsequent mortality (beginning on day 7) in vaccinated versus non-vaccinated women, adjusting for mother’s age at delivery, body mass index, parity, smoking, country of birth, and disposable income and for sex of offspring.
Study answer and limitations
The results of this study suggest that AS03 adjuvanted H1N1 vaccination during pregnancy does not affect the risk of stillbirth, early neonatal death, or later mortality in the offspring. During follow-up, 1172 stillbirths, 380 early neonatal deaths, and 706 deaths thereafter occurred. Compared with general population controls, this corresponded to adjusted hazard ratios of 0.83 (95% confidence interval 0.65 to 1.04) for stillbirth, 0.71 (0.44 to 1.14) for early neonatal death, and 0.97 (0.69 to 1.36) for later death. When siblings were used as controls, adjusted hazard ratios were 0.88 (0.59 to 1.30) for stillbirth, 0.82 (0.46 to 1.49) for early neonatal death, and 0.78 (0.52 to 1.19) for later death. Limitations of the study include lack of data on miscarriage before gestational week 22, inability to ascertain which mothers had pandemic flu during pregnancy, and lack of data on factors influencing the decision to vaccinate during pregnancy.
What this study adds
H1N1 vaccination during pregnancy is not associated with adverse fetal outcome or offspring mortality, including when familial factors are taken into account.
Funding, competing interests, data sharing
This project was supported by grants from the Swedish Research Council and the Swedish Council for Working Life and Social Research. NF was employed at the Swedish Medical Product Agency at the time of the study.

Nosocomial transmission of avian influenza A (H7N9) virus in China: epidemiological investigation
BMJ 2015; 351 :h5765 (Published 19 November 2015)
Open Access

Nosocomial transmission of avian influenza virus A (H7N9)
BMJ 2015; 351 :h5980 (Published 19 November 2015)

Globalization and Health [Accessed 21 November 2015]

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 21 November 2015]

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Research
‘They hear “Africa” and they think that there can’t be any good services’ – perceived context in cross-national learning: a qualitative study of the barriers to Reverse Innovation
Harris M, Weisberger E, Silver D and Macinko J Globalization and Health 2015, 11:45 (19 November 2015)

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Research
Rethinking health care commercialization: evidence from Malaysia
Nwagbara VC and Rasiah R Globalization and Health 2015, 11:44 (19 November 2015)
Abstract
Background
Against the backdrop of systemic inefficiency in the public health care system and the theoretical claims that markets result in performance and efficiency improvement, developing countries’ governments have been rapidly commercializing health care delivery. This paper seeks to determine whether commercialization through an expansion in private hospitals has led to performance improvements in public hospitals.
Methods
Inpatient utilization records of all public hospitals in Peninsular Malaysia over the period 2006–2010 were used in this study. These records were obtained from the Ministry of Health. The study relied on utilization ratios, bed occupancy rates (BOR), bed turnover rates (BTR) and average length of stay (ALOS). The data were analyzed using SPSS 22 Statistical Software and the Pabon Lasso technique.
Results
Over 60 % of public hospitals in Malaysia are inefficient and perform sub-optimally. Average BOR among the public hospitals was 56 % in 2006 and 61 % in 2010. There was excessive BTR of 65 and 73 times within the period. Overall, the ALOS was low, falling from 3.4 days in 2006 to 3.1 days in 2010.
Conclusions
This study demonstrates that commercialization has not led to performance improvements in the public health care sector in Malaysia. The evidence suggests that efforts to improve performance will require a focus directly on public hospitals.

Journal of the Pediatric Infectious Diseases Society (JPIDS) – Volume 4 Issue 4, December 2015

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 4 Issue 4 December 2015
http://jpids.oxfordjournals.org/content/current

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Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12–15 Months
Maurice A. Mufson, Clemente Diaz, Michael Leonardi, Christopher J. Harrison, Stanley Grogg,
Antonio Carbayo, Simon Carlo-Torres, Robert JeanFreau, Ana Quintero-Del-Rio, Gisele Bautista,
Michael Povey, Christopher Da Costa, Ouzama Nicholson, and Bruce L. Innis
J Ped Infect Dis (2015) 4 (4): 339-348 doi:10.1093/jpids/piu081
Free Full Text (HTML)
Abstract
Background
M-M-RTMII (MMRII; Merck & Co) is currently the only measles-mumps-rubella (MMR) vaccine licensed in the United States. Another licensed vaccine would reinforce MMR supply. This study assessed the immunogenicity of a candidate vaccine (PriorixTM, GlaxoSmithKline Vaccines [MMR-RIT]) when used as a first dose among eligible children in the United States.
Methods
In this exploratory Phase-2, multicenter, observer-blind study, 1220 healthy subjects aged 12–15 months were randomized (3:3:3:3) and received 1 dose of 1 of 3 MMR-RIT lots with differing mumps virus titers (MMR-RIT-1 [4.8 log10]; MMR-RIT-2 [4.1 log10]; MMR-RIT-3 [3.7 log10] CCID50) or MMRII co-administered with hepatitis A vaccine (HAV), varicella vaccine (VAR) and 7-valent pneumococcal conjugate vaccine (PCV7). Immune response to measles, mumps, and rubella viruses was evaluated at Day 42 post-vaccination. Incidence of solicited injection site, general, and serious adverse events was assessed.
Results
Seroresponse rates for MMR vaccine viral components in MMR-RIT lots were 98.3–99.2% (measles), 89.7–90.7% (mumps), and 97.5–98.8% (rubella), and for MMRII were 99.6%, 91.1%, and 100%, respectively. Immune responses to HAV, VAR, and PCV7 were similar when co-administered with any of the 3 MMR-RIT lots or MMRII. There were no apparent differences in solicited or serious adverse events among the 4 groups.
Conclusions
Immune responses were above threshold levels for projected protection against the 3 viruses from MMR-RIT lots with differing mumps virus titers. MMR-RIT had an acceptable safety profile when co-administered with HAV, VAR, and PCV7.
Clinical Trials Registration NCT00861744; etrack; 111870

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Efficacy of a Tetravalent Dengue Vaccine in Children in Latin America
Rana F. Hamdy
Author Affiliations
Division of Infectious Diseases, The Children’s Hospital of Philadelphia
Received July 9, 2015.
Accepted August 1, 2015.
Villar L, Dayan GH, Arredondo-Garcia JL, et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med 2015; 372:113–23.
Extract
Dengue is a mosquito-borne disease caused by 1 of 4 virus serotypes from the flavivirus genus present in tropical and subtropical regions. This study reports the results from a phase 3 randomized, blinded, placebo-controlled efficacy trial of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) involving healthy children ages 9 to 16 years in 5 Latin American countries.
The study, sponsored by Sanofi Pasteur, took place in 22 centers in Colombia, Brazil, Mexico, Puerto Rico, and Honduras from June 2011 to March 2012. The investigational vaccine consists of 4 recombinant dengue vaccine viruses, which were constructed by replacing the genes that encode the premembrane and envelope proteins of the yellow fever 17D vaccine virus with those from wild-type dengue viruses…

Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial

The Lancet
Nov 21, 2015 Volume 386 Number 10008 p2029-2116
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Violence against women and girls: how far have we come?
The Lancet
DOI: http://dx.doi.org/10.1016/S0140-6736(15)01029-6
Summary
A year ago, The Lancet published a Series on violence against women and girls ahead of the International Day for the Elimination of Violence against Women on Nov 25. The day marks the start of the 16 Days of Activism against Gender-Based Violence, which this year, for the first time, has prevention as its theme. This focus is encouraging. One in three women will experience physical and/or sexual violence in their lifetime but, as evidence in the Series showed, such violence is preventable. The authors found that community and group interventions involving men and women can shift entrenched social norms and attitudes to reduce the risk of violence against women and girls, but concerted efforts were needed for change

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Comment
Towards therapeutic vaccination against cervical precancer?
Mark Schiffman, Nicolas Wentzensen
Published Online: 16 September 2015
DOI: http://dx.doi.org/10.1016/S0140-6736(15)00240-8
Summary
In The Lancet, Cornelia Trimble and colleagues1 report the results of a double-blind, randomised controlled trial of therapeutic human papillomavirus (HPV) vaccination. Three doses of an intramuscular HPV-16 and HPV-18 plasmid vaccine significantly increased histological regression of cervical precancers caused by HPV types 16 and 18. At 36 weeks after the first dose, regression of cervical intraepithelial neoplasia 2/3 was 48·2% compared with a spontaneous rate in the placebo group of 30·0% (difference 18·2%, 95% CI 1·3–34·4).

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Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial
Cornelia L Trimble, Matthew P Morrow, Kimberly A Kraynyak, Xuefei Shen, Michael Dallas, Jian Yan, Lance Edwards, R Lamar Parker, Lynette Denny, Mary Giffear, Ami Shah Brown, Kathleen Marcozzi-Pierce, Divya Shah, Anna M Slager, Albert J Sylvester, Amir Khan, Kate E Broderick, Robert J Juba, Timothy A Herring, Jean Boyer, Jessica Lee, Niranjan Y Sardesai, David B Weiner, Mark L Bagarazzi
Summary
Background
Despite preventive vaccines for oncogenic human papillomaviruses (HPVs), cervical intraepithelial neoplasia (CIN) is common, and current treatments are ablative and can lead to long-term reproductive morbidity. We assessed whether VGX-3100, synthetic plasmids targeting HPV-16 and HPV-18 E6 and E7 proteins, delivered by electroporation, would cause histopathological regression in women with CIN2/3.
Methods
Efficacy, safety, and immunogenicity of VGX-3100 were assessed in CIN2/3 associated with HPV-16 and HPV-18, in a randomised, double-blind, placebo-controlled phase 2b study. Patients from 36 academic and private gynaecology practices in seven countries were randomised (3:1) to receive 6 mg VGX-3100 or placebo (1 mL), given intramuscularly at 0, 4, and 12 weeks. Randomisation was stratified by age (<25 vs ≥25 years) and CIN2 versus CIN3 by computer-generated allocation sequence (block size 4). Funder and site personnel, participants, and pathologists were masked to treatment. The primary efficacy endpoint was regression to CIN1 or normal pathology 36 weeks after the first dose. Per-protocol and modified intention-to-treat analyses were based on patients receiving three doses without protocol violations, and on patients receiving at least one dose, respectively. The safety population included all patients who received at least one dose. The trial is registered at ClinicalTrials.gov (number NCT01304524) and EudraCT (number 2012-001334-33).
Findings
Between Oct 19, 2011, and July 30, 2013, 167 patients received either VGX-3100 (n=125) or placebo (n=42). In the per-protocol analysis 53 (49·5%) of 107 VGX-3100 recipients and 11 (30·6%) of 36 placebo recipients had histopathological regression (percentage point difference 19·0 [95% CI 1·4–36·6]; p=0·034). In the modified intention-to-treat analysis 55 (48·2%) of 114 VGX-3100 recipients and 12 (30·0%) of 40 placebo recipients had histopathological regression (percentage point difference 18·2 [95% CI 1·3–34·4]; p=0·034). Injection-site reactions occurred in most patients, but only erythema was significantly more common in the VGX-3100 group (98/125, 78·4%) than in the placebo group (24/42, 57·1%; percentage point difference 21·3 [95% CI 5·3–37·8]; p=0·007).
Interpretation
VGX-3100 is the first therapeutic vaccine to show efficacy against CIN2/3 associated with HPV-16 and HPV-18. VGX-3100 could present a non-surgical therapeutic option for CIN2/3, changing the treatment outlook for this common disease.
Funding
Inovio Pharmaceuticals.

Vaccine-Resistant Malaria

New England Journal of Medicine
November 19, 2015 Vol. 373 No. 21
http://www.nejm.org/toc/nejm/medical-journal

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Editorials
Vaccine-Resistant Malaria
C.V. Plowe
[Free Full Text]
To ensure efficacy against wild poliovirus, Jonas Salk methodically classified circulating polio strains before choosing three to use in his inactivated vaccine.1 Several other successful vaccines against viruses and bacteria have likewise included immunogen variants that were selected through careful assessments of pathogen genetic diversity and strain-specific protective immunity.

In contrast, virtually all vaccines against the malaria parasite Plasmodium falciparum, including RTS,S/AS01, have been designed with the use of genetic sequences that are derived from a single, well-characterized reference strain thought to be of West African origin — 3D7. In light of the extreme diversity of malaria parasites, could this “freezer epidemiology” approach to vaccine development be one reason it has been so hard to make an effective malaria vaccine?

Phase 2 field trials of two malaria vaccines targeting highly polymorphic blood-stage antigens have shown strain-specific efficacy — that is, parasites that are genetically divergent from the strain used in the vaccine escaped its effect.2,3 However, field trials of RTS,S, which is based on the pre-erythrocytic P. falciparum circumsporozoite protein, showed no clear evidence of strain-specific efficacy.4,5 Circumsporozoite protein has polymorphism within two major T-cell epitopes, and although there is some variation in the immunodominant central repeat region, for decades it has been hoped that antibodies targeting a single dominant epitope based on the tetrapeptide repeat NANP would provide strain-transcending immunity. A molecular epidemiologic study showed no evidence of naturally acquired strain-specific immunity to different variants of circumsporozoite protein in African children,6 which added to the hope that RTS,S might not be threatened by “vaccine-resistant malaria.”7

These previous studies each examined malaria parasites in a few hundred children at a single African site and were constrained by the challenges of sequencing the long central repeat region of the circumsporozoite protein. Neafsey et al.8 now describe in the Journal how they used next-generation sequencing to measure strain-specific efficacy in a phase 3 trial of RTS,S/AS01 involving 15,000 children at 11 study sites across Africa. Parasite DNA was extracted from several thousand dried blood spots collected from children who were randomly assigned to receive the malaria vaccine or a control vaccine, and the efficacy of the vaccine against infection and clinical malaria with circumsporozoite protein identical to, or different from, the vaccine strain 3D7 was measured by means of a sieve analysis.9

The approach is straightforward: if vaccine-induced immunity is acting like a sieve that filters out parasites that are identical to the vaccine strain at immunologically important polymorphic amino acid positions, then less vaccine-type malaria should occur among vaccinated children, as compared with the control group. The large sample size was needed — vaccine-type parasites were in the minority at all study sites. Several predetermined analyses examining different variant components of circumsporozoite protein showed that, at least in older children, RTS,S/AS01 was indeed better at protecting against malaria caused by vaccine-type parasites. There was no such allele-specific efficacy in young infants, a group in which RTS,S efficacy was lower and in which there may have been different immune responses to both vaccination and malaria infection.

The effect of parasite genetic diversity on efficacy in older children was modest. Various measures of efficacy were approximately 10 to 15 percentage points lower when they were evaluated against non–vaccine-type parasites. This is a much smaller blow to efficacy than the more than 40-point deficit seen with a blood-stage vaccine.3

If we had a vaccine with 80% or 90% efficacy, we might be willing to accept a loss of this magnitude. But RTS,S/AS01 starts off with about 50 to 60% efficacy at best; the efficacy is lower in younger children, and it wanes over time. As this first malaria vaccine moves toward licensure, the results of this study should give pause to those considering whether, where, and when to deploy it. If RTS,S/AS01 is introduced into wide use, over time the loss of efficacy could be more profound than that seen during just a year of follow-up among children who are exposed to a large surrounding population of malaria parasites that are not under selection pressure from vaccine-induced immunity. The most prudent course may be to use RTS,S/AS01 in the specific populations that will benefit most, while redoubling efforts to improve this pioneering vaccine on the basis of new understanding provided by this study of the strain-specific basis of its partial efficacy.

The news is not all bad. The modest loss of efficacy against divergent parasites implies that RTS,S/AS01 offers some degree of cross-protection — vaccine escape is not complete. A multivalent version of RTS,S with carefully chosen circumsporozoite protein variants, possibly combined with additional antigens, might offer broader protection.10 The large set of molecular epidemiologic data on the prevalence of circumsporozoite protein variants across Africa that was generated for this study should provide the evidence needed to select a combination of strains for a more broadly efficacious, next-generation malaria vaccine.

The First Use of the Global Oral Cholera Vaccine Emergency Stockpile: Lessons from South Sudan

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 21 November 2015)

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The First Use of the Global Oral Cholera Vaccine Emergency Stockpile: Lessons from South Sudan
Abdinasir Abubakar, Andrew S. Azman, John Rumunu, Iza Ciglenecki, Trina Helderman, Haley West, Justin Lessler, David A. Sack, Stephen Martin, William Perea, Dominique Legros, Francisco J. Luquero
Health in Action | published 17 Nov 2015 | PLOS Medicine
10.1371/journal.pmed.1001901
Summary Points
:: A global oral cholera vaccine (OCV) stockpile was established in 2013 to improve rapid access to the vaccine in outbreaks and emergencies in which cholera risk is high. The first deployment from the global OCV stockpile was to South Sudan in 2014 because of high cholera risk from massive population displacements within the civil war.
:: 256,700 doses of OCV were delivered, with high coverage, throughout the country as part of a comprehensive cholera prevention strategy by multiple agencies, some of which had little to no previous experience with this vaccine.
:: A cholera epidemic began during vaccination, and a basic comparison of epidemic curves in vaccinated and unvaccinated areas suggests little to no transmission occurred in vaccinated areas, though more in depth analysis is needed.
:: This deployment highlights the feasibility of effective deployments from the OCV stockpile and the importance of strong coordination between governmental and nongovernmental agencies in cholera prevention and control planning from the assessment of cholera risk to the deployment of the vaccines.
:: A larger global supply of OCV is urgently needed to cover those most in need. With limited vaccine availability now and likely in the upcoming years, more work is needed on deciding how to most efficiently use the vaccine, which may include alternative dosing regimens and targeting specific subpopulations.

Developing and Optimising the Use of Logic Models in Systematic Reviews: Exploring Practice and Good Practice in the Use of Programme Theory in Reviews

PLoS One
http://www.plosone.org/
[Accessed 21 November 2015]

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Developing and Optimising the Use of Logic Models in Systematic Reviews: Exploring Practice and Good Practice in the Use of Programme Theory in Reviews
Dylan Kneale, James Thomas, Katherine Harris
Research Article | published 17 Nov 2015 | PLOS ONE
10.1371/journal.pone.0142187
Abstract
Background
Logic models are becoming an increasingly common feature of systematic reviews, as is the use of programme theory more generally in systematic reviewing. Logic models offer a framework to help reviewers to ‘think’ conceptually at various points during the review, and can be a useful tool in defining study inclusion and exclusion criteria, guiding the search strategy, identifying relevant outcomes, identifying mediating and moderating factors, and communicating review findings.
Methods and Findings
In this paper we critique the use of logic models in systematic reviews and protocols drawn from two databases representing reviews of health interventions and international development interventions. Programme theory featured only in a minority of the reviews and protocols included. Despite drawing from different disciplinary traditions, reviews and protocols from both sources shared several limitations in their use of logic models and theories of change, and these were used almost unanimously to solely depict pictorially the way in which the intervention worked. Logic models and theories of change were consequently rarely used to communicate the findings of the review.
Conclusions
Logic models have the potential to be an aid integral throughout the systematic reviewing process. The absence of good practice around their use and development may be one reason for the apparent limited utility of logic models in many existing systematic reviews. These concerns are addressed in the second half of this paper, where we offer a set of principles in the use of logic models and an example of how we constructed a logic model for a review of school-based asthma interventions.

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH) – September 2015

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
September 2015 Vol. 38, No. 3
http://www.paho.org/journal/

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SERIES ON EQUITY IN HEALTH AND SUSTAINABLE DEVELOPMENT
Social determinants and inequalities in tuberculosis incidence in Latin America and the Caribbean [Determinantes sociales y desigualdades en la incidencia de tuberculosis en América Latina y el Caribe]
César V. Munayco, Oscar J. Mújica, Francisco X. León, Mirtha del Granado, and Marcos A. Espinal

La ventaja epidemiológica de la orientación preferencial del control de la tuberculosis hacia los pobres [The epidemiological advantage of preferential targeting of tuberculosis control at the poor]
J. R. Andrews, S. Basu, D. W. Dowdy, and M. B. Murray

Feature What does a disease deserve?

Science
20 November 2015 vol 350, issue 6263, pages 885-1000
http://www.sciencemag.org/current.dtl

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Feature
What does a disease deserve?
Jocelyn Kaiser
Since the early 1990s, Congress and the National Institutes of Health (NIH) have agreed to dedicate roughly 10% of the NIH budget to fighting HIV/AIDS. Now, however, that special arrangement is under fire. Health policy experts, lawmakers, and even NIH officials have wondered why, 2 decades after AIDS death rates began dropping dramatically in the United States, the disease still gets a lion’s share of NIH resources, or $3 billion this year. As questions have arisen about how HIV/AIDS research funds are spent, NIH has also resolved to refocus AIDS money on ending the epidemic. Some voice a broader critique: that NIH’s spending on a disease often doesn’t align with how much suffering it causes. They note that diseases imposing a relatively small burden on U.S. society, such as AIDS, can get a larger share of NIH funding than those that cause greater harm, such as heart disease. Recently, while responding to pointed questions from a member of Congress about the issue, NIH Director Francis Collins said the agency is ready to abandon the 10% set-aside. And next month officials are expected to release an agency-wide strategic plan that they say will address how disease burden should influence the allocation of research dollars.