European Medicines Agency [to 18 June 2016]
http://www.ema.europa.eu/

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17/06/2016
EMA Management Board: highlights of June 2016 meeting
:: New civil society representatives join the Board; EMA multiannual work plan to 2020 and overarching stakeholder relations management framework adopted
:: New civil society representatives join the Board

[Excerpt]
…Overarching framework for stakeholder relations management adopted
The Board adopted EMA’s framework for stakeholder relations management, a high level document which outlines the overarching principles for managing EMA’s key stakeholder interactions. The framework builds on the Agency’s experience in interacting with stakeholder associations representing patients and consumers, healthcare professionals, the pharmaceutical industry and, more recently, academia. The aim of this overarching framework is to streamline interaction activities across the various stakeholder groups and align working methodologies where possible.

The Board also adopted the criteria to be fulfilled by industry stakeholder organisations to be eligible for direct involvement in the Agency’s activities. These eligibility criteria stem from the Agency’s framework for interaction between EMA and industry stakeholders that was adopted last year, and will come into effect on 15 January 2017…

Global Fund [to 18 June 2016]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=

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17 June 2016
Global Fund and Stop TB Partnership Sign Memorandum of Understanding with Global Drug Facility
GENEVA – The Stop TB Partnership today signed a Memorandum of Understanding with the Global Fund to Fight AIDS, Tuberculosis and Malaria to optimize access to TB health products and pharmaceutical services in countries receiving Global Fund financing for TB.

The Stop TB Partnership’s Global Drug Facility (GDF) is the largest supplier of quality assured patient treatments, including first line drugs, second line drugs and pediatric formulations, as well as diagnostics. It is a unique TB medicines procurement mechanism, and provides targeted technical assistance, innovative supply management tools and institutional capacity strengthening to countries for accelerated uptake of new TB products.

The Global Fund and Stop TB Partnership recognize the potential for a more strategic partnership between the Global Fund and Stop TB Partnership’s GDF and the mutual benefits to be gained through structured, collaborative engagement to optimize TB markets and improve the supply chain of TB health products to countries supported by the Global Fund.

“By signing this memorandum of understanding, we can strengthen the global response to ending TB and get the diagnostics and medicines to those who need it the most,” said Lucica Ditiu, Executive Director of the Stop TB Partnership. “This agreement solidifies the very reasons that our GDF was created and will expand access to quality-assured anti-TB medicines and TB health products, including the introduction of new medicines and tools and regimens.”

Under the agreement, the Global Fund and Stop TB will align pooled procurement and market shaping strategies, demand forecasting, and continuous performance improvement activities…

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Belgium Announces Commitment to the Global Fund
15 June 2016
BRUSSELS – The Government of Belgium announced today a pledge of €19 million to the Global Fund to Fight AIDS, Tuberculosis and Malaria for 2016, a positive signal as the Global Fund prepares for a Replenishment conference later this year.

“Belgium has been an active partner of the Global Fund since its inception and it is very encouraging that they are maintaining their financial commitment with the Global Fund partnership,” said Mark Dybul, Executive Director of the Global Fund. “We look forward to continue our work in partnership so that together we can end the three diseases.”…

PATH [to 18 June 2016]
http://www.path.org/news/index.php

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Announcement | June 13, 2016
PATH launches campaign to highlight and advance the Innovation Effect
Events in Washington, DC and digital campaign focus on the vital role of innovation to tackle global health challenges, and aim to identify actions that power disruptive solutions.

Today, PATH is launching a new conversation and call-to-action to highlight and drive forward the Innovation Effect. The Innovation Effect happens when unique partnerships, disruptive technologies, transformed systems, and data-driven insights combine—in often unexpected ways—creating dramatic improvements in the health and well-being of people around the world.

The campaign will kick off with two events—held with partners from across public and private sectors—and a series of digital activities to drive engagement in Washington, DC, as well as online through #InnovationEffect…

Industry Watch [to 18 June 2016]

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:: Systematic Review of 58 Publications of Real-World Use of GARDASIL® Presented at EUROGIN Congress
Studies Published over the Last 10 Years Report Reductions in Cervical Pre-cancers and Other HPV-related Diseases
June 16, 2016
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, announced today that in a systematic review conducted of the global impact and effectiveness of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], substantial reductions were observed in HPV 6/11/16/18-related infection, genital warts, Pap abnormalities and cervical pre-cancers. This evaluation of 58 effectiveness and impact studies published during the past 10 years examined the use of GARDASIL in routine vaccination programs in Australia, Europe, North America and New Zealand, and will be presented for the first time during an oral session at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) congress in Austria. A paper detailing this review was also published online on June 14 in the journal Clinical Infectious Diseases (CID).

Following introduction of vaccination programs with GARDASIL, the earliest impact of the vaccine was seen in the reduction of genital warts. Reductions in genital warts were observed in all nine countries included in this review (based on 28 publications), with declines occurring as early as one year after vaccine introduction in Australia and Germany. Reductions in HPV 6/11/16/18 infection, assessed in 14 publications from five countries (Australia, Belgium, Germany, Sweden and the United States), were also observed shortly after vaccination; for example, reductions in HPV 6/11/16/18 infection were seen within four years in several studies from Australia and the United States. Subsequently, as successive birth cohorts began cervical screening, reductions in cervical pre-cancers were observed within 3-5 years of vaccine program implementation in Australia, Canada, Denmark, Sweden and the United States…

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:: Biopharma contributes to key global health discussions at WHA69
17 June 2016
:: New resolutions adopted by the World Health Assembly included rules on relations the World Health Organization can have with the private sector, amongst others; structures for R&D funding and coordination; access to medicines and integrated health services; global sector strategies on HIV, hepatitis and STIs.
:: Decisions have been taken also on important public health issues: Anti-microbial Resistance (AMR); the implementation of health-related Sustainable Development Goals (SDGs).
:: Numerous satellite events (including two hosted by the IFPMA and several by IFPMA members) enriched the week of deliberations.

Geneva, 6 June 2016 – The 69th World Health Assembly (23-28 May 2016) concluded with 193 countries taking decisions on a number of important issues that will shape the global health agenda and guide the World Health Organization’s (WHO) work in the years to come. As an organization in official relations with the UN, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) made three statements at this year’s World Health Assembly.

FENSA – After years of complex negotiations, the World Health Organization’s (WHO) Framework for Engagement with Non-State Actors (FENSA) was adopted. The resolution asks for immediate implementation of the framework and the full establishment of the register of Non State Actors. It provides the organization with policies and procedures on engaging with non-governmental organizations, private sector entities, philanthropic foundations, and academic institutions. IFPMA has official relations with WHO which will help maintain a close working relationship with the organization.

CEWG – The WHO resolution on research and development funding and coordination (Consultative Expert Working Group/CEWG) saw Member States agree to operationalize the Global Observatory on Health R&D, proposing a way forward to a voluntary pool funding mechanism.

AMR – A report presenting options for establishing a global development and stewardship framework for antimicrobials was noted. Member States highlighted the importance of the “one health” approach to anti-microbial resistance (AMR), strengthening infection prevention and control national strategies, surveillance and laboratory capacities, and the need to regulate the use of antibiotics without hampering access…

Center for Global Development [to 18 June 2016]
http://www.cgdev.org/page/press-center

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6/14/16
Global Health, Aid and Corruption: Can We Escape the Scandal Cycle?
William Savedoff, Amanda Glassman, and Janeen Madan
Global health action has been remarkably successful at saving lives and preventing illness in many of the world’s poorest countries. This is a key reason that funding for global health initiatives has increased in the last twenty years. Nevertheless, financial support is periodically jeopardized when scandals erupt over allegations of corruption, sometimes halting health programs altogether.

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 18 June 2016)

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Research article
Insufficient access to oral paediatric medicines in Ghana: A descriptive study
Daniel N A Ankrah, Joseph T Turkson, Edith B Boateng, Frank T T Amegavie and Elizabeth Bruce
BMC Health Services Research 2016 16:198
Published on: 17 June 2016
Abstract
Background
Among the most vulnerable people in society are children and this is especially so in their access to health care Off-label prescription of paediatric medicines is known to be associated with safety outcomes some of which may be serious. This study identifies frequently prescribed children’s medicines that are not readily available in Ghana and are prepared extemporaneously.
Method
All prescriptions for extemporaneous oral preparations for children presented to the local production unit of the Korle-Bu Teaching Hospital from November, 2013 were eligible for the study. Information from such prescriptions was recorded in a systematic format. Presence of the prescribed medicine on the World Health Organization Children’s Medicine List was ascertained in addition to the anatomical and therapeutic classification code. The registration of the prescribed medicine for paediatric use by the Food and Drugs Authority, Ghana was also checked. Descriptive statistics of the data was presented.
Results
In all 622 prescriptions for 35 different paediatric formulations were served. Prescriptions from several health facilities including government hospitals (6.6 %, N=622), private hospitals (2.4 %, N=622) and the University of Ghana hospital (1.1 %, N=622) were all honoured. Some of the prescribed medicines (Baclofen, Clonazepam, Hydroxyurea and Lamotrigine) were neither on the World Health Organization Children’s Medicine list nor registered with the Food and Drugs Authority, Ghana. Most prescribed medicines (88.6 %, N=35) were for non-communicable diseases.
Conclusion
Paediatric prescriptions including off-label medicines are prescribed and formulated extemporaneously in this setting. Steps should be taken to improve access and monitor benefit-risk profiles of paediatric medicines in order to improve treatment outcomes among children.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 18 June 2016)

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Research article
The incidence, clearance and persistence of non-cervical human papillomavirus infections: a systematic review of the literature
Human papillomavirus (HPV) vaccines were designed to prevent cervical cancer in women and their provision remains a major public health need. However, HPV is also a major cause of non-cervical anogenital and o…
Sylvia Taylor, Eveline Bunge, Marina Bakker and Xavier Castellsagué
BMC Infectious Diseases 2016 16:293
Published on: 14 June 2016

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Research article
Changing distribution of age, clinical severity, and genotypes of rotavirus gastroenteritis in hospitalized children after the introduction of vaccination: a single center study in Seoul between 2011 and 2014
This study aimed to explore changes in clinical epidemiology and genotype distribution and their association among hospitalized children with rotavirus gastroenteritis after the introduction of vaccines.
Jung Ok Shim, Ju Young Chang, Sue Shin, Jin Soo Moon and Jae Sung Ko
BMC Infectious Diseases 2016 16:287
Published on: 14 June 2016

BMC Medicine

(Accessed 18 June 2016)

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Research article
Maternal antenatal multiple micronutrient supplementation for long-term health benefits in children: a systematic review and meta-analysis
Multiple micronutrient supplementation for pregnant women reduces low birth weight and has been recommended in low- and middle-income countries (LMICs) to improve child survival, growth and health.
Delan Devakumar, Caroline H. D. Fall, Harshpal Singh Sachdev, Barrie M. Margetts, Clive Osmond, Jonathan C. K. Wells, Anthony Costello and David Osrin
BMC Medicine 2016 14:90
Published on: 16 June 2016

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 18 June 2016)

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Research article
Closing the gap in Australian Aboriginal infant immunisation rates – the development and review of a pre-call strategy
Improving timely immunisation is key to closing the inequitable gap in immunisation rates between Aboriginal children and non-Indigenous children. Aboriginal Immunisation Officers were employed in Hunter New E…
Patrick M. Cashman, Natalie A. Allan, Katrina K. Clark, Michelle T. Butler, Peter D. Massey and David N. Durrheim
BMC Public Health 2016 16:514
Published on: 16 June 2016

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 18 June 2016]

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Research
Dangerous crossing: demographic and clinical features of rescued sea migrants seen in 2014 at an outpatient clinic at Augusta Harbor, Italy
Alessia Trovato, Anthony Reid, Kudakwashe C. Takarinda, Chiara Montaldo, Tom Decroo, Philip Owiti, Francesco Bongiorno and Stefano Di Carlo
Published on: 15 June 2016

Eurosurveillance
Volume 21, Issue 24, 16 June 2016
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

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Research Articles
Preparing to introduce the varicella vaccine into the Italian immunisation programme: varicella-related hospitalisations in Tuscany, 2004–2012
by S Boccalini, P Bonanni, A Bechini
Abstract
A universal immunisation programme against varicella in the form of the measles-mumps-rubella-varicella (MMRV) vaccine for toddlers aged 13–15 months was introduced in Tuscany in July 2008. An assessment of the impact of this programme on varicella-related hospitalisations 4 years after its introduction could further support its adoption at a national level. The hospitalisation data were analysed in two periods: pre-vaccination (2004–2007) and vaccination period (2009–2012). The high coverage of the vaccines (84% in 2012) resulted in a significant decline in notifications, from 33,114 (2004–2007) to 13,184 cases (2009–2012), and also of hospitalisations, from 584 (pre-vaccination period) to 325 (vaccination period). The hospitalisation rate was 4.1 per 100,000 (95% confidence intervals (CI): 3.4–4.7) before the introduction of vaccination, which dropped to 2.2 per 100,000 (95% CI: 1.7–2.7) in the vaccination period (hospitalisation risk ratios: 0.54; 95% CI:  0.472–0.619). The reduction was most significant in the youngest age groups. The introduction of universal vaccination has already led to a significant decline in hospitalisations due to varicella after just 4 years of implementation. Hospitalisation rates fell noticeably among younger individuals involved in the vaccination programme. The decrease in hospitalisation rate in the older age groups suggests a possible indirect protection.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 18 June 2016]
Commentary

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Measuring success in global health diplomacy: lessons from marketing food to children in India
Global health diplomacy (GHD) focuses on international negotiation; principally between nation states, but increasingly non-state actors However, agreements made at the global level have to be enacted at the n…
Richard Smith and Rachel Irwin
Globalization and Health 2016 12:28
Published on: 16 June 2016

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Methodology
Assessing the health impact of transnational corporations: its importance and a framework
The adverse health and equity impacts of transnational corporations’ (TNCs) practices have become central public health concerns as TNCs increasingly dominate global trade and investment and shape national eco…
Frances E. Baum, David M. Sanders, Matt Fisher, Julia Anaf, Nicholas Freudenberg, Sharon Friel, Ronald Labonté, Leslie London, Carlos Monteiro, Alex Scott-Samuel and Amit Sen
Globalization and Health 2016 12:27
Published on: 15 June 2016

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 18 June 2016]

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Research
Can a quality improvement project impact maternal and child health outcomes at scale in northern Ghana?
Quality improvement (QI) interventions are becoming more common in low- and middle-income countries, yet few studies have presented impact evaluations of these approaches. In this paper, we present an impact e…
Kavita Singh, Paul Brodish, Ilene Speizer, Pierre Barker, Issac Amenga-Etego, Ireneous Dasoberi, Ernest Kanyoke, Eric A. Boadu, Elma Yabang and Sodzi Sodzi-Tettey
Health Research Policy and Systems 2016 14:45
Published on: 16 June 2016

JAMA
June 14, 2016, Vol 315, No. 22
http://jama.jamanetwork.com/issue.aspx

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Viewpoint
Is the United States Prepared for a Major Zika Virus Outbreak? FREE
Lawrence O. Gostin, JD; James G. Hodge Jr, JD, LLM
[Initial text]
From its initial discovery in Ugandan forests nearly 70 years ago, Zika virus has emerged as a worldwide public health crisis, with active transmission in more than 40 countries in the Americas and Caribbean. On February 1, 2016, the World Health Organization (WHO) declared a Public Health Emergency of International Concern (PHEIC), concerned about clusters of microcephaly and Guillain-Barré syndrome (GBS). A week later, the Centers for Disease Control and Prevention (CDC) triggered the highest “level 1” activation of its emergency operations center, and President Obama requested $1.86 billion in emergency funding.1 On April 7, the WHO reported there is scientific consensus that Zika is a cause of microcephaly and GBS.

Although none of the continental states has reported local mosquito-borne transmission, Health Secretary Sylvia Burwell warned that Zika has a “significant potential to affect national security or the health of Americans.”2 The virus severely threatens Puerto Rico, with one-quarter of its 3.5 million inhabitants projected to be infected.3 The Olympics in Brazil will have an amplifying affect because the competition will be during the Northern summer. Travelers visiting or returning to the United States could likely escalate the spread of Zika. Epidemiologists estimate that Zika could affect a majority of US states including large cities where Aedes species mosquitos are active.

Is the United States prepared for major clusters of Zika? Certainly, a highly functioning health system will help protect the domestic population. Yet there are signs of unpreparedness with insufficient resources and variable legal authorities…

The Lancet
Jun 18, 2016 Volume 387 Number 10037 p2479-2574
http://www.thelancet.com/journals/lancet/issue/current

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Comment
AIDS 2016: from aspiration to implementation
Kenneth H Mayer, Olive Shisana, Chris Beyrer
Summary
Since AIDS was first recognised in 1981, more than 75 million HIV infections and more than 36 million deaths have occurred.1 HIV infection is no longer an inexorable death sentence but a chronic manageable infection. Key factors responsible for this transformation have been an understanding of the modes of HIV transmission,2 the development of effective combination antiretroviral therapy,3 and the validation of surrogate markers to monitor the response to treatment.4 But currently less than half of all people living with HIV worldwide have access to life-saving antiretroviral therapy,5 at a time when donor interest is uncertain and global funding flattening.

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Articles
National spending on health by source for 184 countries between 2013 and 2040
Joseph L Dieleman, Tara Templin, Nafis Sadat, Patrick Reidy, Abigail Chapin, Kyle Foreman, Annie Haakenstad, Tim Evans, Christopher J L Murray, Christoph Kurowski
2521
Summary
Background
A general consensus exists that as a country develops economically, health spending per capita rises and the share of that spending that is prepaid through government or private mechanisms also rises. However, the speed and magnitude of these changes vary substantially across countries, even at similar levels of development. In this study, we use past trends and relationships to estimate future health spending, disaggregated by the source of those funds, to identify the financing trajectories that are likely to occur if current policies and trajectories evolve as expected.
Methods
We extracted data from WHO’s Health Spending Observatory and the Institute for Health Metrics and Evaluation’s Financing Global Health 2015 report. We converted these data to a common purchasing power-adjusted and inflation-adjusted currency. We used a series of ensemble models and observed empirical norms to estimate future government out-of-pocket private prepaid health spending and development assistance for health. We aggregated each country’s estimates to generate total health spending from 2013 to 2040 for 184 countries. We compared these estimates with each other and internationally recognised benchmarks.
Findings
Global spending on health is expected to increase from US$7·83 trillion in 2013 to $18·28 (uncertainty interval 14·42–22·24) trillion in 2040 (in 2010 purchasing power parity-adjusted dollars). We expect per-capita health spending to increase annually by 2·7% (1·9–3·4) in high-income countries, 3·4% (2·4–4·2) in upper-middle-income countries, 3·0% (2·3–3·6) in lower-middle-income countries, and 2·4% (1·6–3·1) in low-income countries. Given the gaps in current health spending, these rates provide no evidence of increasing parity in health spending. In 1995 and 2015, low-income countries spent $0·03 for every dollar spent in high-income countries, even after adjusting for purchasing power, and the same is projected for 2040. Most importantly, health spending in many low-income countries is expected to remain low. Estimates suggest that, by 2040, only one (3%) of 34 low-income countries and 36 (37%) of 98 middle-income countries will reach the Chatham House goal of 5% of gross domestic product consisting of government health spending.
Interpretation
Despite remarkable health gains, past health financing trends and relationships suggest that many low-income and lower-middle-income countries will not meet internationally set health spending targets and that spending gaps between low-income and high-income countries are unlikely to narrow unless substantive policy interventions occur. Although gains in health system efficiency can be used to make progress, current trends suggest that meaningful increases in health system resources will require concerted action.

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Articles
Development assistance for health: past trends, associations, and the future of international financial flows for health
Joseph L Dieleman, Matthew T Schneider, Annie Haakenstad, Lavanya Singh, Nafis Sadat, Maxwell Birger, Alex Reynolds, Tara Templin, Hannah Hamavid, Abigail Chapin, Christopher J L Murray
2536
Summary
Background
Disbursements of development assistance for health (DAH) have risen substantially during the past several decades. More recently, the international community’s attention has turned to other international challenges, introducing uncertainty about the future of disbursements for DAH.
Methods
We collected audited budget statements, annual reports, and project-level records from the main international agencies that disbursed DAH from 1990 to the end of 2015. We standardised and combined records to provide a comprehensive set of annual disbursements. We tracked each dollar of DAH back to the source and forward to the recipient. We removed transfers between agencies to avoid double-counting and adjusted for inflation. We classified assistance into nine primary health focus areas: HIV/AIDS, tuberculosis, malaria, maternal health, newborn and child health, other infectious diseases, non-communicable diseases, Ebola, and sector-wide approaches and health system strengthening. For our statistical analysis, we grouped these health focus areas into two categories: MDG-related focus areas (HIV/AIDS, tuberculosis, malaria, child and newborn health, and maternal health) and non-MDG-related focus areas (other infectious diseases, non-communicable diseases, sector-wide approaches, and other). We used linear regression to test for structural shifts in disbursement patterns at the onset of the Millennium Development Goals (MDGs; ie, from 2000) and the global financial crisis (impact estimated to occur in 2010). We built on past trends and associations with an ensemble model to estimate DAH through the end of 2040.
Findings
In 2015, US$36·4 billion of DAH was disbursed, marking the fifth consecutive year of little change in the amount of resources provided by global health development partners. Between 2000 and 2009, DAH increased at 11·3% per year, whereas between 2010 and 2015, annual growth was just 1·2%. In 2015, 29·7% of DAH was for HIV/AIDS, 17·9% was for child and newborn health, and 9·8% was for maternal health. Linear regression identifies three distinct periods of growth in DAH. Between 2000 and 2009, MDG-related DAH increased by $290·4 million (95% uncertainty interval [UI] 174·3 million to 406·5 million) per year. These increases were significantly greater than were increases in non-MDG DAH during the same period (p=0·009), and were also significantly greater than increases in the previous period (p<0·0001). Between 2000 and 2009, growth in DAH was highest for HIV/AIDS, malaria, and tuberculosis. Since 2010, DAH for maternal health and newborn and child health has continued to climb, although DAH for HIV/AIDS and most other health focus areas has remained flat or decreased. Our estimates of future DAH based on past trends and associations present a wide range of potential futures, although our mean estimate of $64·1 billion (95% UI $30·4 billion to $161·8 billion) shows an increase between now and 2040, although with a large uncertainty interval.
Interpretation
Our results provide evidence of two substantial shifts in DAH growth during the past 26 years. DAH disbursements increased faster in the first decade of the 2000s than in the 1990s, but DAH associated with the MDGs increased the most out of all focus areas. Since 2010, limited growth has characterised DAH and we expect this pattern to persist. Despite the fact that DAH is still growing, albeit minimally, DAH is shifting among the major health focus areas, with relatively little growth for HIV/AIDS, malaria, and tuberculosis. These changes in the growth and focus of DAH will have critical effects on health services in some low-income countries. Coordination and collaboration between donors and domestic governments is more important than ever because they have a great opportunity and responsibility to ensure robust health systems and service provision for those most in need.

The Milbank Quarterly
A Multidisciplinary Journal of Population Health and Health Policy
June 2016 Volume 94, Issue 2 Pages 225–435
http://onlinelibrary.wiley.com/doi/10.1111/1468-0009.2016.94.issue-2/issuetoc

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Original Investigation
The International Health Regulations: The Governing Framework for Global Health Security
LAWRENCE O. GOSTIN1,* and REBECCA KATZ2
Version of Record online: 11 MAY 2016
DOI: 10.1111/1468-0009.1218
Abstract
Context
The International Health Regulations (IHR) have been the governing framework for global health security for the past decade and are a nearly universally recognized World Health Organization (WHO) treaty, with 196 States Parties. In the wake of the Ebola epidemic, major global commissions have cast doubt on the future effectiveness of the IHR and the leadership of the WHO.
Methods
We conducted a review of the historical origins of the IHR and their performance over the past 10 years and analyzed all of the ongoing reform panel efforts to provide a series of politically feasible recommendations for fundamental reform.
Findings
We propose a series of recommendations with realistic pathways for change. These recommendations focus on the development and strengthening of IHR core capacities; independently assessed metrics; new financing mechanisms; harmonization with the Global Health Security Agenda, Performance of Veterinary Services (PVS) Pathways, the Pandemic Influenza Preparedness Framework, and One Health strategies; public health and clinical workforce development; Emergency Committee transparency and governance; tiered public health emergency of international concern (PHEIC) processes; enhanced compliance mechanisms; and an enhanced role for civil society.
Conclusions
Empowering the WHO and realizing the IHR’s potential will shore up global health security—a vital investment in human and animal health—while reducing the vast economic consequences of the next global health emergency.

Nature
Volume 534 Number 7607 pp296-430 16 June 2016
http://www.nature.com/nature/current_issue.html

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Policy: Map the interactions between Sustainable Development Goals
Måns Nilsson, Dave Griggs and Martin Visbeck present a simple way of rating relationships between the targets to highlight priorities for integrated policy.

Pediatrics
June 2016, VOLUME 137 / ISSUE 6
http://pediatrics.aappublications.org/content/137/6?current-issue=y

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Articles
Immunization Data Exchange With Electronic Health Records
Melissa S. Stockwell, Karthik Natarajan, Rajasekhar Ramakrishnan, Stephen Holleran, Kristen Forney, Angel Aponte, David K. Vawdrey
Pediatrics Jun 2016, 137 (6) e20154335; DOI: 10.1542/peds.2015-4335
Abstract
OBJECTIVE: To assess the impact of exchange of immunization information between an immunization information system (IIS) and an electronic health record on up-to-date rates, over-immunization, and immunization record completeness for low-income, urban children and adolescents.
METHODS: The New York City Department of Health maintains a population-based IIS, the Citywide Immunization Registry (CIR). Five community clinics in New York City implemented direct linkage of immunization data from the CIR to their local electronic health record. We compared immunization status and overimmunization in children and adolescents 19 to 35 month, 7 to 10 year, and 13 to 17 year-olds with provider visits in the 6-month period before data exchange implementation (2009; n = 6452) versus 6-months post-implementation (2010; n = 6124). We also assessed immunization record completeness with and without addition of CIR data for 8548 children and adolescents with visits in 2012–2013.
RESULTS: Up-to-date status increased from before to after implementation from 75.0% to 81.6% (absolute difference, 6.6%; 95% confidence interval [CI], 5.2% to 8.1%) and was significant for all age groups. The percentage overimmunized decreased from 8.8% to 4.7% (absolute difference, −4.1%; 95% CI, −7.8% to −0.3%) and was significant for adolescents (16.4% vs 1.2%; absolute difference, −15.2%; 95% CI, −26.7 to −3.6). Up-to-date status for those seen in 2012 to 2013 was higher when IIS data were added (74.6% vs 59.5%).
CONCLUSIONS: This study demonstrates that data exchange can improve child and adolescent immunization status. Development of the technology to support such exchange and continued focus on local, state, and federal policies to support such exchanges are needed.

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Strategies for Improving Vaccine Delivery: A Cluster-Randomized Trial
Linda Y. Fu, Kathleen Zook, Janet A. Gingold, Catherine W. Gillespie, Christine Briccetti, Denice Cora-Bramble, Jill G. Joseph, Rachel Haimowitz, Rachel Y. Moon
Pediatrics Jun 2016, 137 (6) e20154603; DOI: 10.1542/peds.2015-4603
Abstract
OBJECTIVE: New emphasis on and requirements for demonstrating health care quality have increased the need for evidence-based methods to disseminate practice guidelines. With regard to impact on pediatric immunization coverage, we aimed to compare a financial incentive program (pay-for-performance [P4P]) and a virtual quality improvement technical support (QITS) learning collaborative.
METHODS: This single-blinded (to outcomes assessor), cluster-randomized trial was conducted among unaffiliated pediatric practices across the United States from June 2013 to June 2014. Practices received either the P4P or QITS intervention. All practices received a Vaccinator Toolkit. P4P practices participated in a tiered financial incentives program for immunization coverage improvement. QITS practices participated in a virtual learning collaborative. Primary outcome was percentage of all needed vaccines received (PANVR). We also assessed immunization up-to-date (UTD) status.
RESULTS: Data were analyzed from 3,147 patient records from 32 practices. Practices in the study arms reported similar QI activities (∼6 to 7 activities). We found no difference in PANVR between P4P and QITS (mean ± SE, 90.7% ± 1.1% vs 86.1% ± 1.3%, P = 0.46). Likewise, there was no difference in odds of being UTD between study arms (adjusted odds ratio 1.02, 95% confidence interval 0.68 to 1.52, P = .93). In within-group analysis, patients in both arms experienced nonsignificant increases in PANVR. Similarly, the change in adjusted odds of UTD over time was modest and nonsignificant for P4P but reached significance in the QITS arm (adjusted odds ratio 1.28, 95% confidence interval 1.02 to 1.60, P = .03).
CONCLUSIONS: Participation in either a financial incentives program or a virtual learning collaborative led to self-reported improvements in immunization practices but minimal change in objectively measured immunization coverage.

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Influenza in Infants Born to Women Vaccinated During Pregnancy
Julie H. Shakib, Kent Korgenski, Angela P. Presson, Xiaoming Sheng, Michael W. Varner, Andrew T. Pavia, Carrie L. Byington
Pediatrics Jun 2016, 137 (6) e20152360; DOI: 10.1542/peds.2015-2360

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Commentaries
Immunization Delivery and Policy as an Ongoing Model for Systems Improvement
Simon J. Hambidge
Pediatrics Jun 2016, 137 (6) e20160962; DOI: 10.1542/peds.2016-0962
Initial text
Immunization delivery has long served as a model of the interface between health care and public health. The article by Stockwell et al in this issue of Pediatrics1 illustrates the power of this interface.
The authors studied the impact of a bidirectional exchange of pediatric immunization information between an electronic health record in a large urban ambulatory care network and a citywide immunization information system. They found that immunization up-to-date status increased in all age groups by 81.6% after implementation of the exchange. Importantly, the percent of overimmunized children decreased from 8.8% to 4.7% and was especially pronounced in adolescents (16.4% overimmunized preimplementation to …

PLOS Currents: Disasters
http://currents.plos.org/disasters/
[Accessed 18 June 2016]

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Discussion
If Numbers Can Speak, Who Listens? Creating Engagement and Learning for Effective Uptake of DRR Investment in Developing Countries
June 13, 2016 ·
Introduction: With a renewed emphasis on evidence-based risk sensitive investment promoted under the Sendai Framework for Disaster Risk Reduction 2015-2030, technical demands for analytical tools such as probabilistic cost-benefit analysis (CBA) will likely increase in the foreseeable future. This begs a number of pragmatic questions such as whether or not sophisticated quantitative appraisal tools are effective in raising policy awareness and what alternatives are available.
Method: This article briefly reviews current practices of analytical tools such as probabilistic cost-benefit analysis and identifies issues associated with its applications in small scale community based DRR interventions.
Results: The article illustrate that while best scientific knowledge should inform policy and practice in principle, it should not create an unrealistic expectation that the state-of-the art methods must be used in all cases, especially for small scale DRR interventions in developing countries, where data and resource limitations and uncertainty are high, and complex interaction and feedback may exist between DRR investment, community response and longer-term development outcome.
Discussion: Alternative and more participatory approaches for DRR appraisals are suggested which includes participatory serious games that are increasingly being used to raise awareness and identify pragmatic strategies for change that are needed to bring about successful uptake of DRR investment and implementation of DRR mainstreaming.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 18 June 2016)

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Essay
Delinking Investment in Antibiotic Research and Development from Sales Revenues: The Challenges of Transforming a Promising Idea into Reality
Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony D. So, Chantal M. Morel, John-Arne Røttingen
| published 14 Jun 2016 | PLOS Medicine
Summary Points
:: The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.
:: Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic—the notion of “delinkage.”
:: Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when resistance renders existing treatments ineffective, an increasingly urgent global problem. The issue of global access to antibiotics is not sufficiently addressed de facto by a delinked mechanism, and, as such, it must be addressed explicitly through specific design features of new mechanisms, including defining the eligibility criteria for delinkage rewards and appropriate management of intellectual property.
:: The idea of establishing a new business model to drive antibiotic development and improve conservation currently has the world’s attention. We must now work quickly to examine the remaining design questions to address this major public health concern for the longer term.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/

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Digital Participatory Surveillance and the Zika Crisis: Opportunities and Caveats
Claudia Pagliari, Santosh Vijaykumar
Viewpoints | published 13 Jun 2016 | PLOS Neglected Tropical Diseases
http://dx.doi.org/10.1371/journal.pntd.0004795
Introduction
Managing the global threat of Zika requires innovative solutions. This article examines the potential of Digital Participatory Surveillance to support the management of global disease outbreaks by enabling citizens to report signs of infection. We discuss the status of the current evidence-base, contextual factors influencing user engagement and data quality, challenges for evaluation, and unique aspects of Zika with implications for design. We also suggest priorities for research, development and practice, to help translate the theoretical benefits of these methods into meaningful improvements in outbreak monitoring and public health.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/

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Research Article
Antibody Secreting Cell Responses following Vaccination with Bivalent Oral Cholera Vaccine among Haitian Adults
Wilfredo R. Matias, Brie Falkard, Richelle C. Charles, Leslie M. Mayo-Smith, Jessica E. Teng, Peng Xu, Pavol Kovac, Edward T. Ryan, Firdausi Qadri, Molly F. Franke, Louise C. Ivers, Jason B. Harris
| published 16 Jun 2016 | PLOS Neglected Tropical Diseases
http://dx.doi.org/10.1371/journal.pntd.0004753
Abstract
Background
The bivalent whole-cell (BivWC) oral cholera vaccine (Shanchol) is effective in preventing cholera. However, evaluations of immune responses following vaccination with BivWC have been limited. To determine whether BivWC induces significant mucosal immune responses, we measured V. cholerae O1 antigen-specific antibody secreting cell (ASC) responses following vaccination.
Methodology/Principal Findings
We enrolled 24 Haitian adults in this study, and administered doses of oral BivWC vaccine 14 days apart (day 0 and day 14). We drew blood at baseline, and 7 days following each vaccine dose (day 7 and 21). Peripheral blood mononuclear cells (PBMCs) were isolated, and ASCs were enumerated using an ELISPOT assay. Significant increases in Ogawa (6.9 cells per million PBMCs) and Inaba (9.5 cells per million PBMCs) OSP-specific IgA ASCs were detected 7 days following the first dose (P < 0.001), but not the second dose. The magnitude of V. cholerae-specific ASC responses did not appear to be associated with recent exposure to cholera. ASC responses measured against the whole lipolysaccharide (LPS) antigen and the OSP moiety of LPS were equivalent, suggesting that all or nearly all of the LPS response targets the OSP moiety.
Conclusions/Significance
Immunization with the BivWC oral cholera vaccine induced ASC responses among a cohort of healthy adults in Haiti after a single dose. The second dose of vaccine resulted in minimal ASC responses over baseline, suggesting that the current dosing schedule may not be optimal for boosting mucosal immune responses to V. cholerae antigens for adults in a cholera-endemic area.
Author Summary
The bivalent whole-cell (BivWC) oral cholera vaccine (Shanchol) is effective in preventing cholera. Despite its increasing use as part of comprehensive cholera prevention and control efforts, evaluations of immune responses following vaccination with BivWC have been limited. In this study, we measured the development of cholera-specific antibody secreting cells, markers of mucosal immunity, following vaccination with BivWC among a population of adults in Haiti, where cholera is now endemic. BivWC induced development of robust immune responses following the first dose of vaccine, but similar ASC responses were not detected following the second dose, suggesting that the currently recommended 14-day interval between doses may not be optimal for boosting mucosal immune responses among adults in cholera endemic regions. These findings suggest that additional evaluation of the optimal dosing schedule for oral cholera vaccines is warranted with the goal of improving long-term immunity.

Vaccine
Volume 34, Issue 28, Pages 3221-3330 (14 June 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/28
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Brief report
Effective vaccine communication during the disneyland measles outbreak
Pages 3225-3228
David A. Broniatowski, Karen M. Hilyard, Mark Dredze
Abstract
Vaccine refusal rates have increased in recent years, highlighting the need for effective risk communication, especially over social media. Fuzzy-trace theory predicts that individuals encode bottom-line meaning (”gist”) and statistical information (”verbatim”) in parallel and those articles expressing a clear gist will be most compelling. We coded news articles (n = 4581) collected during the 2014−2015 Disneyland measles for content including statistics, stories, or bottom-line gists regarding vaccines and vaccine-preventable illnesses. We measured the extent to which articles were compelling by how frequently they were shared on Facebook. The most widely shared articles expressed bottom-line gists, although articles containing statistics were also more likely to be shared than articles lacking statistics. Stories had limited impact on Facebook shares. Results support Fuzzy Trace Theory’s predictions regarding the distinct yet parallel impact of categorical gist and statistical verbatim information on public health communication.

Vaccine
Volume 34, Issue 28, Pages 3221-3330 (14 June 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/28
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Review Article
Using behavior change frameworks to improve healthcare worker influenza vaccination rates: A systematic review
Pages 3235-3242
Kimberly M. Corace, Jocelyn A. Srigley, Daniel P. Hargadon, Dorothy Yu, Tara K. MacDonald, Leandre R. Fabrigar, Gary E. Garber
Abstract
Background
Influenza vaccination of healthcare workers (HCW) is important for protecting staff and patients, yet vaccine coverage among HCW remains below recommended targets. Psychological theories of behavior change may help guide interventions to improve vaccine uptake. Our objectives were to: (1) review the effectiveness of interventions based on psychological theories of behavior change to improve HCW influenza vaccination rates, and (2) determine which psychological theories have been used to predict HCW influenza vaccination uptake.
Methods
MEDLINE, EMBASE, CINAHL, PsycINFO, The Joanna Briggs Institute, SocINDEX, and Cochrane Database of Systematic Reviews were searched for studies that applied psychological theories of behavior change to improve and/or predict influenza vaccination uptake among HCW.
Results
The literature search yielded a total of 1810 publications; 10 articles met eligibility criteria. All studies used behavior change theories to predict HCW vaccination behavior; none evaluated interventions based on these theories. The Health Belief Model was the most frequently employed theory to predict influenza vaccination uptake among HCW. The remaining predictive studies employed the Theory of Planned Behavior, the Risk Perception Attitude, and the Triandis Model of Interpersonal Behavior. The behavior change framework constructs were successful in differentiating between vaccinated and non-vaccinated HCW. Key constructs identified included: attitudes regarding the efficacy and safety of influenza vaccination, perceptions of risk and benefit to self and others, self-efficacy, cues to action, and social-professional norms. The behavior change frameworks, along with sociodemographic variables, successfully predicted 85–95% of HCW influenza vaccination uptake.
Conclusion
Vaccination is a complex behavior. Our results suggest that psychological theories of behavior change are promising tools to increase HCW influenza vaccination uptake. Future studies are needed to develop and evaluate novel interventions based on behavior change theories, which may help achieve recommended HCW vaccination targets.

Vaccine
Volume 34, Issue 28, Pages 3221-3330 (14 June 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/28
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Original Research Article
Communicating to increase public uptake of pandemic flu vaccination in the UK: Which messages work?
Pages 3268-3274
Fiona Mowbray, Afrodita Marcu, Cristina A. Godinho, Susan Michie, Lucy Yardley
Abstract
Background
Vaccination is considered the most effective preventive measure against influenza transmission, yet vaccination rates during the 2009/10 influenza A/H1N1 pandemic were low across the world, with the majority of people declining to receive the vaccine. Despite extensive research on the predictors of uptake of influenza vaccination, little research has focused on testing the effectiveness of evidence and theory-based messages.
Aims
To examine the persuasiveness of messages promoting vaccination and antiviral use either as health-enhancing or as risk-reducing, as well as messages which conveyed evidence-based information about the costs and benefits of vaccination, or which applied anticipated regret as a motivator for vaccine uptake.
Method
We conducted 11 focus groups with forty-one members of the general population in England including young and older adults, those with lower education, parents, and those with elevated health risk. The data were analysed using thematic analysis.
Results
The factual, evidence-based messages were well received with participants finding them the most convincing and useful, particularly where they gave cost–benefit comparisons. Health-enhancing messages were received with scepticism and concern that the messages were not honest about the potential lack of safety of vaccination. In contrast, risk-reduction messages were perceived as being more balanced and credible. Messages aiming to elicit feelings of anticipated regret for not getting vaccinated were generally perceived as patronising and unprofessional.
Conclusions
Vaccination messages should be kept brief, but convey balanced, evidence-based information, and be transparent in their communication of potential side-effects. The general public seem to prefer messages that are factual and emphasise the costs and benefits of vaccination, particularly with regards to vaccine safety.

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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New York Times
http://www.nytimes.com/
Accessed 18 June 2016
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As Zika Threat Grows in U.S., Testing Lags for a Vulnerable Group
By MARC SANTORAJ UNE 17, 2016
As the Zika virus swept north from Brazil into the Caribbean, bringing with it frightening risks for pregnant women and their unborn children, United States health officials decided in February that all expectant women who had visited the countries affected should be tested for the disease.
But after the guidelines were put in place, public health officials and doctors in New York City found that large numbers of women, many uninsured or low-income immigrants from the Caribbean and Latin America, were not being screened and tested in a systematic way.
The problems facing the city’s health care providers in ensuring that all of those who need testing can get it illustrates the monumental challenges involved in reaching those considered most at risk. And as summer approaches, the reach of mosquitoes that carry the virus is expected to extend to Florida and other states along the Gulf of Mexico…

Polio Strain Found in Hyderabad, India, Prompts Vaccination Drive
15 June 2016
NEW DELHI — The health authorities in the southern Indian state of Telangana have issued a high alert in Hyderabad, the state capital, after finding a strain of polio in sewage water there, a state health official said Wednesday.
A polio vaccination drive will begin on Monday, the health authorities said, with the aim of vaccinating about 300,000 children in parts of Hyderabad and in the Rangareddy district also part of the state of Telangana, according to a statement from India’s Ministry of Health and Family Welfare. The Hyderabad metropolitan area has more than 7.7 million people and the Rangareddy district 5.2 million, according India’s 2011 census.
“We have to avoid any kind of risk, even though nobody has been affected,” said Rajeshwar Tiwari, the principal secretary for the Ministry of Health in Telangana. “We want to remain a polio-free nation.”…

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Washington Post
http://www.washingtonpost.com/
Accessed 18 June 2016
Mosquitoes don’t just spread the Zika virus. They may be helping an older killer reemerge.
As global warming continues, yellow fever may start to spread again.
Mara Pillinger | Politics | Jun 16, 2016

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_11 June 2016

– blog edition: comprised of the approx. 35+ entries posted below.

– 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

Zika virus [to 11 June 2016]
Public Health Emergency of International Concern (PHEIC)
http://www.who.int/emergencies/zika-virus/en/

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Zika situation report – 9 June 2016
Full report: http://apps.who.int/iris/bitstream/10665/208877/1/zikasitrep_9Jun2016_eng.pdf?ua=1
Summary
:: As of 8 June 2016, 60 countries and territories report continuing mosquito-borne transmission of which:
…46 countries are experiencing a first outbreak of Zika virus since 2015, with no previous evidence of circulation, and with ongoing transmission by mosquitos.
…14 countries reported evidence of Zika virus transmission between 2007 and 2014, with ongoing transmission.

:: In addition, four countries or territories have reported evidence of Zika virus transmission between 2007 and 2014, without ongoing transmission: Cook Islands, French Polynesia, ISLA DE PASCUA – Chile and YAP (Federated States of Micronesia).

:: Ten countries have reported evidence of person-to-person transmission of Zika virus, probably via a sexual route.

:: In the week to 8 June 2016, no new country reported mosquito-borne or person-to-person Zika virus transmission.

:: As of 8 June 2016, microcephaly and other central nervous system (CNS) malformations potentially associated wit Zika virus infection or suggestive of congenital infection have been reported by eleven countries or territories. Three of those reported microcephaly borne from mothers with a recent travel history to Brazil (Slovenia, United States of America) and Colombia (Spain), for one additional case the precise country of travel in Latin America is not determined.

:: In the context of Zika virus circulation, 13 countries and territories worldwide have reported an increased incidence of Guillain-Barré syndrome (GBS) and/or laboratory confirmation of a Zika virus infection among GBS cases.

:: As of 8 June, Cabo Verde has reported a total of six cases of microcephaly and other neurological abnormalities with serological indication of previous Zika infection. Based on research to date, there is scientific consensus that Zika virus is a cause of microcephaly and GBS.

:: The global Strategic Response Framework launched by the World Health Organization (WHO) in February 2016 encompasses surveillance, response activities and research. An interim report has been published on some of the key activities being undertaken jointly by WHO and international, regional and national partners in response to this public health emergency. A revised strategy for the period July 2016 to December 2017 is currently being developed with partners and will be published in mid-June.

:: WHO has developed new advice and information on diverse topics in the context of Zika virus. WHO’s latest information materials, news and resources to support corporate and programmatic risk communication, and community engagement are available online.

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Guidance for health workers
:: Prevention of sexual transmission 7 June 2016

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Zika Open [to 11 June 2016]
[Bulletin of the World Health Organization]
:: All papers available here
RESEARCH IN EMERGENCIES
Zika virus infection in pregnancy: a systematic review of disease course and complications
– Ezinne C Chibueze, Veronika Tirado, Katharina da Silva Lopes, Olukunmi O Balogun, Yo Takemoto,a Toshiyuki Swa, Amarjargal Dagvadorj, Chie Nagata, Naho Morisaki, Clara Menendez, Erika Ota, Rintaro Mori, Olufemi T Oladapo
Posted: 9 June 2016
http://dx.doi.org/10.2471/BLT.16.178426
pdf, 240kb

EBOLA/EVD [to 11 June 2016]
“Threat to international peace and security” (UN Security Council)

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EBOLA VIRUS DISEASE – Situation Report – 10 JUNE 2016
[Excerpt]
Risk assessment:
Guinea and Liberia declared the end of the most recent outbreak of EVD on 1 and 9 June, respectively. The performance indicators suggest that Guinea, Liberia and Sierra Leone still have variable capacity to prevent, detect and respond to new outbreaks (Table 1). The risk of additional outbreaks originating from exposure to infected survivor body fluids remains and requires sustained mitigation through counselling on safe sex practices and testing of body fluids.

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End of the most recent Ebola virus disease outbreak in Liberia
AFRO news release [excerpt]
9 June 2016 | Monrovia – Today the World Health Organization (WHO) declares the end of the most recent outbreak of Ebola virus disease in Liberia. This announcement comes 42 days (two 21-day incubation cycles of the virus) after the last confirmed Ebola patient in Liberia tested negative for the disease for the second time. Liberia now enters a 90-day period of heightened surveillance to ensure that any new cases are identified quickly and contained before spreading.
Read the press release by WHO Regional Office for Africa

POLIO [to 11 June 2016]
Public Health Emergency of International Concern (PHEIC)

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Polio this week as of 7 June 2016
:: As of the 7 June, 149 out of 155 countries and territories have submitted a switch validation report, confirming the withdrawal of tOPV from the immunization programme. Visit this website for a live update of the finalisation of the switch.

:: In Lao PDR the second outbreak response assessment (OBRA) concluded that the country is on track towards interrupting virus transmission. cVDPV1 has not been detected in Lao PDR since 11 January 2016, while AFP surveillance continues to improve.

:: GPEI published the 2013 -2019 Financial Resource Requirements with an overview of the required and available funding for the period.
Selected Country Levels Updates [excerpted]
No new cases identified in country reports.

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GPEI – Financial Resource Requirements (FRRs) 2013-2019 (AS OF 1 APRIL 2016)
June 2016 :: 36 pages
PDF of full report: http://www.polioeradication.org/Portals/0/Document/Financing/FRR_EN_A4.pdf
OVERVIEW
This Financial Resource Requirements (FRRs) report is the budget document accompanying the Polio Eradication & Endgame Strategic Plan 2013-2018 (PEESP) of the Global Polio Eradication Initiative (GPEI). The FRRs are updated twice per year based on evolving epidemiology and available funding. The financial needs reflected in this publication represent the requirements for activities to be implemented by the World Health Organization (WHO), the United Nations Children’s Fund (UNICEF) and Gavi, the Vaccine Alliance (Gavi) in coordination with national governments, and include agency indirect costs where applicable. The FRRs do not include estimations of costs incurred directly by national governments.

While the FRRs only cover the direct budget requirements for WHO, UNICEF and Gavi to implement activities as per the PEESP, the annual Non-FRR Report captures self-reported donor contributions to areas supportive of polio eradication, but that are outside of the FRRs. Non-FRR contributions are either in kind or in cash and are for activities that directly increase the likelihood of the success of the polio eradication programme, but they are not a part of eradication or other activities included in this FRR document. Non-FRR contributions do not decrease outstanding donor commitments to FRR activities.
For additional financing information, see http://www.polioeradication.org/Financing.aspx

Financing
The Global Polio Eradication Initiative (GPEI) is financed by a wide range of public and private donors, who help meet the costs of the Initiative’s eradication activities. The requirements for 2013-2019 are projected to be approximately US$ 7.0 billion.

The Financial Resource Requirements series (FRR) provides an overview of the external funding – required and currently available – to finance activities planned by the GPEI for the 2013-2019 period to eradicate all remaining polio disease – due to both wild and vaccine-related polioviruses and prepare for the post-eradication era in keeping with the Polio Eradication and Endgame Strategic Plan 2013-2018 (PEESP) and its four Objectives.

The budgets that underpin the FRR are prepared jointly by the World Health Organization (WHO), UNICEF and the national governments. The external funds to finance the activities primarily flow through WHO and UNICEF with funds for IPV introduction flowing through Gavi, the Vaccine Alliance. The FRR provides an overview of 2016-2019 and the details for 2016. It is updated regularly, based on evolving epidemiology and available funding.

As of April 2016, the 2016-2019 GPEI budget estimates are US$ 3.864 billion for the major cost categories of the four Objectives of the PEESP. The budgets for each of Objective are overseen by the GPEI’s various oversight and management groups. For 2016, the requirements are US$ 1.393 billion…

Yellow Fever [to 11 June 2016]
http://www.who.int/emergencies/yellow-fever/en/

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Yellow Fever – Situation Report – 9 June 2016
Full Report:
http://apps.who.int/iris/bitstream/10665/208880/1/yellowfeversitrep_9Jun2016_eng.pdf?ua=1

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Yellow fever vaccination campaign in the Democratic Republic of the Congo
As of 2 June 2016, a total of 1 947 567 people have been vaccinated against Yellow Fever in the provinces of Kinshasa and Kongo Central. The vaccination campaign began on 26 May 2016. Many people have rushed to get vaccinated including many people from districts that were not targetted for vaccination. This is good news because it means people understand the importance of vaccination. However, despite concerted efforts by WHO and partners and manufacturers, global vaccine stocks remain low.

Local partners like the Red Cross in the DRC are supporting the campaign. Here a Red Cross volunteer verifies the vaccination cards of the those wanting to get vaccinated to make sure that they have not been vaccinated before. Almost 2000 vaccinators have been mobilized in about 987 vaccination sites (647 in in Kongo Central and 331 in Kinshasa province), together with support from the provincial authorities, WHO, UNICEF, Save the Children and the GAVI Alliance…

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IFRC [to 11 June 2016]
http://www.ifrc.org/en/news-and-media/press-releases/
Red Cross calls for immediate scale-up in response to deadly yellow fever outbreak in Angola
Published: 8 June 2016
Nairobi/Geneva, 8 June 2016 – Concerned by the ongoing spread of the yellow fever outbreak in Angola and beyond, the International Federation of Red Cross and Red Crescent Societies (IFRC) is calling for an immediate scale-up in response.

“Limited vaccine supplies, poor sanitation, inadequate disease surveillance systems and everyday cross-border interaction could turn a national outbreak into a larger crisis, if immediate community-based action is not taken,” said Dr Fatoumata Nafo-Traoré, Director, IFRC Africa region.

The outbreak was first detected in Angola in late December 2015. According to the World Health Organization, close to 2,900 suspected cases have since been reported in all 18 provinces, with 325 deaths. Out of the five countries which have reported imported yellow fever cases that originated in Angola, Democratic Republic of the Congo and Congo are now experiencing outbreaks with local transmission.

“Vaccinations are the first and best line of defence,” said Dr Nafo-Traoré. “However, given the limited supply of yellow fever vaccine globally, we need to prioritize community engagement as a vital tool to prevent the further spread of the disease.”

In Angola and the Democratic Republic of the Congo, the IFRC has deployed Regional Disaster Response Team members, and released start-up funds from its Disaster Relief Emergency Fund to support operations aimed at halting the spread of the virus. Staff and volunteers with the Angola Red Cross have supported the country’s vaccination campaign. They have also been conducting social mobilization in communities, as have personnel from the Red Cross of the Democratic Republic of the Congo. Teams conduct door-to-door visits, instructing people on the measures they can take to reduce their risk of falling ill with yellow fever. This includes vector control to eliminate sites where mosquitoes can breed.

In addition to the ground level work currently being carried out by the World Health Organization, UNICEF and other partners, the IFRC is further deploying a Field Assessment Coordination Team to Angola to conduct an in-depth assessment of needs and gaps, primarily focused on improved community surveillance, vector control, and addressing rumours that are spreading about the disease and vaccinations. The expanded emergency operation will focus on newly-affected districts and in border areas.

Dr Adinoyi Adeiza, IFRC health coordinator, Africa region, said: “With our decades of experience of deploying community-based volunteers to help prevent and respond to vector-borne diseases such as malaria, dengue and chikungunya, the Red Cross can play a key role in managing this outbreak.”

Five countries have reported imported yellow fever cases confirmed to have come from people who had travelled to Angola: 88 in Congo-Brazzaville; 44 in Democratic Republic of the Congo; two each in Kenya and Sao Tome; and 11 in China. “We are extremely concerned about the further spread of this outbreak, particularly to countries bordering Angola, such as Namibia and Zambia,” added Dr Adeiza. “Non-immunized people traveling across these countries could pose a significant risk.”

WHO & Regional Offices [to 11 June 2016]

Safe blood transfusions save lives in South Sudan
10 June 2016 — In places with ongoing conflict, like South Sudan, safe blood transfusions are a life-saving necessity. In the run up to World Blood Donor Day, 14 June 2016, this story highlights the importance of giving blood. The theme of the Day is “Blood connects us all”, and one of its aims is to create wider public awareness of the need for regular blood donation while inspiring those who have not yet donated blood to do so.

Four countries stop mother-to-child transmission of HIV or syphilis
8 June 2016 – WHO congratulates Thailand and Belarus for eliminating mother-to-child transmission of both HIV and syphilis. Likewise, WHO applauds Armenia for eliminating mother-to-child transmission of HIV, and the Republic of Moldova for eliminating mother-to-child transmission of syphilis. A critical factor for country success has been the integration of maternal and child health programmes with sexual health, reproductive health and HIV services.
Read the statement

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Highlights
Eliminating lymphatic filariasis
June 2016 — Maldives and Sri Lanka have eliminated lymphatic filariasis, a disease that was crippling people for decades, forcing them to lead a life of stigma, discrimination and poverty. However, there are still over 1 billion people living in over 50 countries that still have lymphatic filariasis.

End of the most recent Ebola virus disease outbreak in Liberia
June 2016 — It has been 42 days (two 21-day incubation cycles of the virus) after the last confirmed Ebola patient in Liberia tested negative for the disease for the second time. Liberia now enters a 90-day period of heightened surveillance.

Nearly 2 million people vaccinated against yellow fever in the Democratic Republic of the Congo
June 2016 — A total of 1 947 567 people have been vaccinated against yellow fever in the Democratic Republic of the Congo. The vaccination campaign began on 26 May 2016, and many people have rushed to be vaccinated, including people from districts not targeted for vaccination.

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Weekly Epidemiological Record (WER) 10 June 2016, vol. 91, 23 (pp. 296–304)
Contents
297 Epidemic focus: Cholera
298 Pneumococcal meningitis outbreaks in sub-Saharan Africa
302 Influenza vaccine response during the start of a pandemic report of a WHO informal consultation held in Geneva, Switzerland 29 June – 1 July 2015

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Disease Outbreak News (DONs)
:: 8 June 2016 – Human infection with avian influenza A(H5N6) virus – China

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:: WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: African national regulatory agencies and ethics committees agree to harmonise practices to strengthen clinical trial oversight
Addis Ababa, Ethiopia, 10 June 2016 – Heads of national regulatory agencies and national ethics committees from across Africa have agreed to harmonise their practices to strengthen regulatory oversight of clinical trials.

At the end of a two-day extraordinary meeting of the African Vaccine Regulatory Forum (AVAREF) in Addis Ababa, Ethiopia, consensus was reached to expand AVAREF’s scope and membership as well as to promote collaboration, harmonization of regulatory systems and best practices across the continent. This will be accomplished through a new governance structure that will help provide the foundation for the future African Medicines Agency which is scheduled to be launched in 2018.

The World Health Organization (WHO) established the AVAREF in 2006 to address the increased number of clinical trials, limited infrastructure, limited expertise and unclear operating models in African countries. The Forum is comprised of the National Regulatory Agencies (NRAs) and National Ethics Committees of 23 countries targeted for clinical trials of HIV, Malaria and TB vaccines.

“As a network of regulatory authorities and ethics committees, AVAREF has over these years strengthened the capacity of countries in Africa to regulate clinical trials, particularly of vaccines and has contributed to access to important vaccines such as the conjugate meningitis A vaccine, thereby helping to significantly reduce epidemics of meningitis”, said Dr Matshidiso Moeti, WHO Regional Director for Africa, in a speech read on her behalf at the landmark event.

“Despite its success, the network still faces some challenges. The time has come for a new vision and blueprint for AVAREF which takes into account the rapidly evolving global and regulatory environment, as well as the opportunities presented by new initiatives”, she added.

Currently African countries face significant regulatory challenges including the increased circulation of sub-standard/spurious/falsely labeled/falsified/counterfeit products, lack of technical expertise and capacity within individual NRAs and Ethics Committees, among others.
Similarly product developers face challenges associated with disparate application requirements.

In an effort to address these challenges, participants unanimously agreed to expand the existing AVAREF with a new vision to address evolving global and regulatory challenges. The new AVAREF will be a pan-African network to provide robust clinical trial oversight and enhance other regulatory functions to increase access to safe and effective medical products such as medicines, vaccines and diagnostics for the African population. It will also facilitate increased efficiency and build capacity of its membership.

In his remarks, Dr Vincent Ahonkai, Senior Adviser for Regulatory Affairs, from the Bill & Melinda Gates Foundation (BMGF) noted that this vision is a game changer in the continent’s regulatory environment. “We are living in an era of cooperative, collaborative networks, and strategic alliances. Building an efficient clinical trial platform is a core component of access to quality health products for Africa. AVAREF aims to build that platform and is a welcome initiative that will benefit the citizens of Africa,” he said.

Speaking to reporters at the event, Dr Thomas Nyirenda, Director at the European and Developing Countries Clinical Trials Partnership (EDCTP) said: “Alignment, harmonization and expansion of the scope of AVAREF taking into account other regional initiatives on the African continent is timely and will complement the efforts of EDCTP which has an expanded mandate to fund all phases of clinical trials for products against targeted diseases”.

Over 70 participants attended the meeting, including delegates from Member States, Regional Economic Communities, African Union Commission, NEPAD Agency, product developers, development partners and technical experts.

:: WHO declares the end of the most recent Ebola virus disease outbreak in Liberia – 09 June 2016

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WHO Region of the Americas PAHO
:: Latin America and the Caribbean approaching half-way mark toward goal of 100% voluntary blood donation (06/10/2016)

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WHO South-East Asia Region SEARO
:: Thailand is first country in Asia to eliminate mother-to-child transmission of HIV and syphilis
07 June 2016

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WHO European Region EURO
:: One nurse’s quest to track down TB on the eastern edge of Greenland 10-06-2016
:: WHO validates elimination of mother-to-child transmission of HIV and syphilis in Armenia, Belarus and the Republic of Moldova 08-06-2016
:: Fighting TB in Greenland 07-06-2016

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WHO Eastern Mediterranean Region EMRO
:: Kuwait supports insulin-dependent Syrians 8 June 2016
:: “We came with nothing, we have nothing”: thousands flee Fallujah as fighting intensifies
6 June 2016
:: Egypt’s deworming campaign targets 2 million school-age children June 2016

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WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 11 June 2016]
http://www.cdc.gov/media/index.html

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MMWR June 10, 2016 / Vol. 65 / No. 22
:: Elimination of Mother-to-Child Transmission of HIV — Thailand
:: Influenza Activity — United States, 2015–16 Season and Composition of the 2016–17 Influenza Vaccine

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June ACIP meeting
June 22-23, 2016
Deadline for registration:
:: Non-US Citizens: May 20, 2016
:: US Citizens: June 6, 2016
Registration is NOT required to watch the live meeting webcast or to listen via telephone.
Draft June 22-23, 2016 Meeting Agenda[2 pages]

FDA [to 11 June 2016]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

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June 10, 2016
FDA approves vaccine to prevent cholera for travelers
The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.

… “The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by the Centers for Disease Control and Prevention for travelers to cholera-affected regions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

…Vaxchora is a live, weakened vaccine that is taken as a single, oral liquid dose of approximately three fluid ounces at least 10 days before travel to a cholera-affected area.

Vaxchora’s efficacy was demonstrated in a randomized, placebo-controlled human challenge study of 197 U.S. volunteers from 18 through 45 years of age. Of the 197 volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae, the bacterium that causes cholera. Vaxchora efficacy was 90 percent among those challenged 10 days after vaccination and 80 percent among those challenged three months after vaccination. The study included provisions for administration of antibiotics and fluid replacement in symptomatic participants. To prevent transmission of cholera into the community, the study included provisions for administration of antibiotics to participants not developing symptoms.

Two placebo-controlled studies to assess the immune system’s response to the vaccine were also conducted in the U.S. and Australia in adults 18 through 64 years of age. In the 18 through 45 year age group, 93 percent of Vaxchora recipients produced antibodies indicative of protection against cholera. In the 46 through 64 years age group, 90 percent produced antibodies indicative of protection against cholera. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas.

The safety of Vaxchora was evaluated in adults 18 through 64 years of age in four randomized, placebo-controlled, multicenter clinical trials; 3,235 study participants received Vaxchora and 562 received a placebo. The most common adverse reactions reported by Vaxchora recipients were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea.

The FDA granted the Vaxchora application fast track designation and priority review status. These are distinct programs intended to facilitate and expedite the development and review of medical products that address a serious or life-threatening condition. In addition, the FDA awarded the manufacturer of Vaxchora a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.
Vaxchora is manufactured by PaxVax Bermuda Ltd., located in Hamilton, Bermuda…

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What’s New for Biologics
June 10, 2016 Approval Letter – VAXCHORA (PDF – 60KB)
Posted: 6/10/2016

Sabin Vaccine Institute [to 11 June 2016]
http://www.sabin.org/updates/ressreleases

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Tuesday, June 7, 2016
Closing Immunity Gaps in Measles and Rubella Elimination
…While many countries are succeeding in the strengthening of their routine immunization programs, over half the world’s children are not vaccinated against rubella. Progress is being stifled by a number of hurdles, especially outbreaks, revealing a new challenge of vaccinating older children and adults. The consequences of the devastating outcomes of congenital rubella syndrome are obvious and provide an urgent call for action.

To that end, from May 10-11, 2016, 46 representatives from 23 countries gathered in Siena, Italy, to identify challenges and best practices for achieving high vaccination coverage among older children and adults. Attendees included measles and rubella focal points from national immunization programs, representatives from the U.S. Centers for Diseases Control and Prevention (CDC), the WHO and its regional offices as well as civil society leaders from various international pediatric associations and Lions Club chapters.

The cornerstone of the agenda was sharing experiences and exchanging ideas on strategies and tactical measures to close immunity gaps in these age groups from a country-based perspective. Presentations revealed unique approaches to maintaining high routine coverage, such as Australia’s “No Jab, No Pay” law as well as experiences with campaigns when dealing with high influx of migrants or refugees. Discussions and group exercises focused on methods for obtaining high-quality data coverage in all age groups, identifying areas and groups at risk, and implementing effective actions when gaps in immunity are identified.

A coalition of partners supported the meeting, including; American Academy of Pediatrics (AAP), CDC, International Pediatric Association (IPA), Lions Clubs International Foundation, Sabin Vaccine Institute, and the WHO.
Presentations from the meeting can be found here.

GHIT Fund [to 11 June 2016]
https://www.ghitfund.org/
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical companies, the Japanese Government and the Bill & Melinda Gates Foundation.

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2016.06.06 Press Room
GHIT Fund Welcomes Ten New Partnerships With FUJIFILM, Otsuka, GSK, Johnson & Johnson, Kyowa Hakko Kirin, Merck, Mitsubishi Tanabe, Nipro, Sumitomo Dainippon Pharma and Salesforce.com
Expansion will allow continued investments in R&D for neglected diseases, which in just three years has led to over 60 funded partnerships for the product development of new drugs, vaccines and diagnostics, seven of which have entered clinical trials

TOKYO, JAPAN (June 6, 2016)—The Global Health Innovative Technology Fund (GHIT Fund) today welcomed ten new partnerships that include major global pharmaceutical and biotechnology companies—collaborations that will expand investments into research and development (R&D) for neglected diseases worldwide, many of which have already begun to show progress in clinical trials.

The new collaborations include a full funding partnership with FUJIFILM Corporation, an associate partnership with Otsuka Pharmaceutical, affiliate partnerships with GlaxoSmithKline, Johnson & Johnson, Kyowa Hakko Kirin, Merck, Mitsubishi Tanabe Pharma Corporation, Nipro Corporation, Sumitomo Dainippon Pharma, and a sponsorship from Salesforce.com.

“We are excited to welcome these new funding partners—from within Japan and across the globe—who have joined forces with the GHIT Fund because of their own unique commitments to global health, as well as their confidence that working together will transform R&D,” GHIT Fund CEO Dr. BT Slingsby said. “The partnerships will not only broaden our scope, but also increase our ability to reach the world’s most vulnerable people with lifesaving technology.”

GHIT’s announcement today also marks its third year investing in R&D for neglected diseases, having now allocated more than US$60 million into upwards of 60 collaborations for product development. Of these investments, 23 have resulted in partnerships to screen Japan’s unique compound libraries, resulting in 18 potential drug candidates. GHIT grants in 2015 alone have also led to five projects advancing into its innovative hit-to-lead platform (HTLP), as well as four novel candidates entering clinical trials for the first time—two in Phase I (first-in-human) and two in Phase II (including one proof-of-concept)…

Fondation Merieux [to 11 June 2016]
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
http://www.fondation-merieux.org/news

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9 June 2016, Paris (France)
Professor Francine Ntoumi Winner of the 2016 Christophe Mérieux Prize
The 2016 Christophe Mérieux prize has been awarded to Professor Francine Ntoumi of the Faculty of Science and Engineering of Brazzaville (Congo) at a ceremony that took place at the Institut de France on 8th June, to encourage her work in infectious diseases in Central Africa.

IAVI – International AIDS Vaccine Initiative [to 11 June 2016]
http://www.iavi.org/

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June 8, 2016
Ending AIDS Will Require Innovation in HIV Prevention – Especially a Vaccine
UN High Level Meeting highlights successes and continued needs in the global fight for a world without AIDS

New York – IAVI has joined world leaders, researchers and advocates gathered at UN Headquarters for a three-day conference aimed at accelerating progress toward an ambitious goal—to end AIDS by 2030. Delegates to the High-Level Meeting on Ending AIDS have called for accelerated action against the disease through intensified prevention, treatment, care and support programs that will help reduce new infections and increase life expectancy, quality of life and the dignity of all people living with, at risk of, and affected by HIV/AIDS and their families.

“The global fight against HIV/AIDS is one of the greatest challenges of modern times. The delegates in New York, as well as civil society, governments, international agencies, researchers and health care professionals around the world deserve to be congratulated for unprecedented solidarity, political will, innovation and funding that have enabled remarkable progress in treatment and prevention,” says Mark Feinberg, IAVI’s President and CEO. “And while we must make maximum use of all available tools, there is an urgent need to continue to invest in new prevention tools, including a vaccine, as well as a cure. Only a comprehensive response will rid the world of HIV/AIDS once and for all.”

Current trends suggest that existing treatment and prevention options are not sufficient to stanch the AIDS epidemic. “We need innovation in HIV prevention,” says Feinberg. “We must better understand people’s constraints and preferences in using HIV prevention, and make sure they can access and adhere to existing methods. But we will also need new approaches that better reflect people’s lives. Vaccines have proven to be the most effective tool to help control and eradicate infectious diseases.”

While remarkable progress has been made, the HIV/AIDS epidemic is far from being over. While 17 million people were receiving antiretroviral treatment by the end of 2015, nearly 20 million people living with HIV worldwide still didn’t have access to treatment. Ambitious targets have helped save millions of lives and reduce new annual infections by more than 30% since 2000. However, infection rates have leveled around 2 million for more than five years now despite more-than-doubled treatment rates. In 2015, new HIV infections increased for the first time in 15 years, by 5 percent, to 2.1 million globally.

Sub-Saharan Africa was home to two-thirds of the world’s new HIV infections in 2015. Women there are shouldering a disproportionate share of the burden, and infection rates among that demographic as well as the large and fast-growing group of young people remain alarmingly high. Meanwhile, new HIV infections in Eastern Europe and Central Asia rose by 57 percent in 2015 alone.

High-Level Meeting on Ending AIDS – June 2016

Political Declaration on HIV and AIDS: On the Fast-Track to Accelerate the Fight against HIV and to End the AIDS Epidemic by 2030
UN General Assembly Seventieth session
Agenda item 11
Implementation of the Declaration of Commitment on HIV/AIDS and the political declarations on HIV/AIDS
[Selected paragraphs referencing vaccines]
48: Welcome the important progress achieved in research for new biomedical tools for prevention, notably regarding Treatment as Prevention, pre-exposure prophylaxis (PrEP) and ARV-based microbicides and voluntary medical male circumcision, but also recognize that research and development must be accelerated, including for long-acting formulations of PrEP, preventive and therapeutic HIV vaccines, and curative interventions;..

60 (e): Work towards achieving universal health coverage that comprises equitable and universal access to quality health-care services, including sexual and reproductive health, and social protection, and includes financial risk protection, and access to safe, effective, quality and affordable essential medicines and vaccines for all, including the development of new service delivery models to improve efficiency, lower costs, and ensure delivery of more integrated services for HIV, TB, viral hepatitis, sexually transmitted infections, non-communicable diseases, including cervical cancer, drug dependence, food and nutrition support, maternal, child and adolescent health, men’s health, mental health and sexual and reproductive health, and to address gender-based and sexual violence, in order to equip fragile communities to cope with these issues as well as future disease outbreaks;…

64 (d): Strongly urge increased investments in comprehensive research and development to enable access to improved and affordable point-of-care diagnostics, A/70/L.52
23/26 16-09119

prevention commodities, including preventive and therapeutic vaccines, and female-initiated prevention commodities, more tolerable, efficacious and affordable health technologies and products, including simpler and more effective drug formulations for children, adolescents and adults, second-and third-line therapy, new drugs and diagnostics for tuberculosis, viral load monitoring tools, microbicides and a functional cure, while seeking to ensure that sustainable systems for vaccine procurement and equitable distribution are also developed, and in this context, encourage other forms of incentives for research and development such as the exploration of new incentive systems including those in which research and development costs are delinked from product prices…

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Press release
Bold commitments to action made at the United Nations General Assembly High-Level Meeting on Ending AIDS
The new Political Declaration adopted by United Nations Member States charts a course to end AIDS as a public health threat by 2030
UNITED NATIONS, NEW YORK, 10 June 2016—United Nations Member States have committed to implementing a bold agenda to end the AIDS epidemic by 2030 during the United Nations General Assembly High-Level Meeting on Ending AIDS, held in New York, United States of America, from 8 to 10 June. The progressive, new and actionable Political Declaration includes a set of specific, time-bound targets and actions that must be achieved by 2020 if the world is to get on the Fast-Track and end the AIDS epidemic by 2030 within the framework of the Sustainable Development Goals.

The High-Level Meeting on Ending AIDS was convened by the President of the General Assembly and co-facilitated by Switzerland and Zambia. At the opening, the President of the General Assembly, Mogens Lykketoft, urged Member States to commit to action.

“All stakeholders must now step up to the plate. Today is the day that we collectively say that we will end the AIDS epidemic by 2030,” said Mr Lykketoft. “We must pay greater attention to equality and inclusion, uphold human rights and speak out against stigma and discrimination.”
During the opening plenary, the United Nations Secretary-General, Ban Ki-moon, said that the AIDS response had been a “source of innovation and inspiration,” and the Executive Director of UNAIDS outlined the progress made in recent years, with 17 million people accessing antiretroviral treatment and significant declines in AIDS-related deaths and new HIV-infections among children.

“For the first time in history we can say that in Africa there are more people initiating HIV treatment than there are new HIV infections,” said UNAIDS Executive Director Michel Sidibé. He also underlined the importance of inclusion, saying, “The doors of the United Nations should be open to all.”

In addition to the plenary sessions around 600 participants, including 10 Heads of State and Government and more than 60 ministers, people living with HIV, representatives of civil society, representatives of international organizations and the private sector, scientists and researchers took part in five official panels and more than 30 side events to translate the new Political Declaration into action and results.

The five official panels were under the following themes:
:: AIDS within the Sustainable Development Goals: leveraging the end of AIDS for social transformation and sustainable development.
:: Financing and sustaining the end of AIDS: the window of opportunity.
:: Getting ahead of the looming treatment crisis: an action agenda for getting to 90–90–90.
:: Leaving no one behind: ending stigma and discrimination through social justice and inclusive societies.
:: Children, adolescent girls and young women: preventing new HIV infections.

Participants called for access to comprehensive sexuality education and harm reduction services as well as strengthening outreach to young women and adolescent girls and key populations, including men who have sex with men, sex workers, people who inject drugs, transgender people and prisoners as well as migrants.

During the High-Level Meeting on Ending AIDS, major announcements were made in support of ending the epidemic by 2030:

:: The United States of America announced the launch of a new US$ 100 million Key Populations Investment Fund to increase access to HIV services for sex workers, gay men and other men who have sex with men, people who inject drugs, transgender people and prisoners. The new fund will focus on reducing stigma and discrimination, empowering community leadership in the design and delivery of services and increasing the quality of data on key populations.

:: Yusuf K. Hamied, Chair of the Indian pharmaceutical company CIPLA, announced a package of assistance to African countries to facilitate the local production of medicines in Africa.

:: UNAIDS and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) released a final report on the progress made since the Global Plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive was launched at the last United Nations General Assembly High-Level Meeting on HIV and AIDS, in 2011.

There has been a 60% decline in new HIV infections among children since 2009 in the 21 countries in sub-Saharan Africa that have been most affected by the epidemic. To build on the enormous progress made in stopping new HIV infections among children, UNAIDS, PEPFAR and partners released a framework for ending AIDS among children, adolescents and young women—Start Free, Stay Free, AIDS-Free. The initiative sets ambitious targets to eliminate new infections among children, ensure access to treatment for all children living with HIV and prevent new HIV infections among adolescents and young women in order to put the world on a path to ending the AIDS epidemic among young women, adolescents and children.

:: Armenia, Belarus and Thailand joined Cuba in receiving official certificates of validation from the World Health Organization for eliminating new HIV infections among children. Thailand is the first country with a major HIV epidemic (450 000 people living with HIV in 2014) to receive such validation.

Events were held on the wider health agenda, including learning the lessons learned from responding to emerging epidemics, such as AIDS, Ebola and Zika, and on empowering adolescent girls and young women to access integrated health-care services, which was organized by the Organisation of African First Ladies against HIV/AIDS.

Addressing the Challenges of Influenza Vaccination on US College Campuses
A report by the National Foundation for Infectious Diseases
May 2016 :: 10 pages
Overview
According to the Centers for Disease Control and Prevention (CDC), annual vaccination is the best way to reduce the chances that an individual will get influenza (flu). Yet on US college campuses, flu vaccination rates remain strikingly low, hovering between eight and 39 percent,1, 2, 3, 4 and falling dramatically short of the 70 percent Healthy People 2020 target recommendation5 as well as the American College Health Association (ACHA) Healthy Campus 2020 target goal of approximately 50 percent.6

Motivating college students to get an annual flu vaccination remains a public health challenge; therefore, the National Foundation for Infectious Diseases (NFID) convened a College Influenza Stakeholder Summit that included subject matter experts from academia, student organizations, professional medical associations, patient advocacy organizations, and industry (see page 8 for a complete list of participating organizations) to better understand the causes behind this vaccination gap. By bringing together these experts, the Summit sought to better understand the key barriers that prevent college students from getting an annual flu vaccine, as well as to identify strategies which would help students both recognize their risk and motivate them to get vaccinated.

Journal Watch

Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.

  If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 11 June 2016)

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Research
Mothers’ willingness to pay for HPV vaccines in Anambra state, Nigeria: a cross sectional contingent valuation study
Ifeoma Blessing Umeh, Sunday Odunke Nduka and Obinna Ikechukwu Ekwunife
Published: 6 June 2016
Abstract
Background
Human papilloma virus (HPV) vaccination in Nigeria will require substantial financing due to high cost of HPV vaccine and inexistence of structures to support adolescent vaccination. Alternative sources are needed to sustain the government funded HPV vaccination programme. This study assessed Nigerian mothers’ willingness-to-pay (WTP) for HPV vaccine. We also compared the difference between the average WTP and estimated costs of vaccinating a pre-adolescent girl (CVG).
Methods
We conducted a quantitative, cross-sectional, survey-based study in which 50 questionnaires were distributed to each of 10 secondary schools located in two rural and one urban city in Anambra state. The questionnaires were then randomly distributed to girls aged 9–12 years of age to give to their mothers. Contingent valuation approach using the payment card technique was used to estimate the average maximum WTP among the survey participants. Correlates of WTP for HPV vaccination were obtained using multivariate logistic regression. Estimated CVG was obtained by adapting cost of HPV vaccine delivery in Tanzania to the Nigerian setting.
Results
A total of 438 questionnaires (88 %) were returned. The average WTP was US$ 11.68. This is opposed to estimated delivery cost of US$ 18.16 and US$ 19.26 for urban and rural populations respectively at vaccine price offered by the Vaccine Alliance (Gavi) and US$ 35.16 and US$ 36.26 for urban and rural populations respectively at the lowest obtainable public sector vaccine price. Demand for HPV vaccine was deemed high (91.6 %) and was significantly associated with respondents previously diagnosed of HPV infection.
Conclusion
Demand for HPV vaccine was high although short of estimated CVG. High demand for vaccine should be capitalized upon to increase vaccine uptake. Education on cervical cancer and provider-initiated vaccination should be promoted to increase vaccine uptake. Co-payment could be a feasible financing strategy in the event of national HPV vaccination.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 June 2016)

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Research article
A survey of tuberculosis infection control practices at the NIH/NIAID/DAIDS-supported clinical trial sites in low and middle income countries
Health care associated transmission of Mycobacterium tuberculosis (TB) is well described. A previous survey of infection control (IC) practices at clinical research sites in low and middle income countries (LMIC)…
Catherine Godfrey, Gail Tauscher, Sally Hunsberger, Melissa Austin, Lesley Scott, Jeffrey T. Schouten, Anne F. Luetkemeyer, Constance Benson, Robert Coombs and Susan Swindells
BMC Infectious Diseases 2016 16:269
Published on: 10 June 2016

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Research article
Global research trends of Middle East respiratory syndrome coronavirus: a bibliometric analysis
Middle East respiratory syndrome coronavirus (MERS-CoV) is a virus that causes severe viral pneumonia in humans, known to have a high mortality rate and a similarity in clinical symptoms with severe acute resp...
Sa’ed H. Zyoud
BMC Infectious Diseases 2016 16:255
Published on: 7 June 2016

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 11 June 2016)

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Research article
Steps toward improving ethical evaluation in health technology assessment: a proposed framework
While evaluation of ethical aspects in health technology assessment (HTA) has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response …
Nazila Assasi, Jean-Eric Tarride, Daria O’Reilly and Lisa Schwartz
BMC Medical Ethics 2016 17:34
Published on: 6 June 2016

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Debate
Citizen science or scientific citizenship? Disentangling the uses of public engagement rhetoric in national research initiatives
The language of “participant-driven research,” “crowdsourcing” and “citizen science” is increasingly being used to encourage the public to become involved in research ventures as both subjects and scientists. …
J. Patrick Woolley, Michelle L. McGowan, Harriet J. A. Teare, Victoria Coathup, Jennifer R. Fishman, Richard A. Settersten, Sigrid Sterckx, Jane Kaye and Eric T. Juengst
BMC Medical Ethics 2016 17:33
Published on: 4 June 2016

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 11 June 2016)

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Research article
Impact of interventions to improve the quality of peer review of biomedical journals: a systematic review and meta-analysis
The peer review process is a cornerstone of biomedical research. We aimed to evaluate the impact of interventions to improve the quality of peer review for biomedical publications.
Rachel Bruce, Anthony Chauvin, Ludovic Trinquart, Philippe Ravaud and Isabelle Boutron
BMC Medicine 2016 14:85
Published on: 10 June 2016

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content

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Research article
Religious beliefs and practices in pregnancy and labour: an inductive qualitative study among post-partum women in Ghana
Religiosity in health care delivery has attracted some attention in contemporary literature. The religious beliefs and practices of patients play an important role in the recovery of the patient.
Lydia Aziato, Philippa N. A. Odai and Cephas N. Omenyo
BMC Pregnancy and Childbirth 2016 16:138
Published on: 6 June 2016

Disasters
July 2016 Volume 40, Issue 3 Pages 385–588
http://onlinelibrary.wiley.com/doi/10.1111/disa.2016.40.issue-3/issuetoc

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Papers
Barriers to the long-term recovery of individuals with disabilities following a disaster (pages 387–410)
Laura M. Stough, Amy N. Sharp, J. Aaron Resch, Curt Decker and Nachama Wilker
Version of Record online: 17 NOV 2015 | DOI: 10.1111/disa.12161
Abstract
This study examines how pre-existing disabling conditions influenced the recovery process of survivors of Hurricane Katrina. It focuses specifically on the barriers that hindered the recovery process in these individuals. Focus groups were convened in four Gulf Coast states with 31 individuals with disabilities who lived in or around New Orleans, Louisiana, prior to Hurricane Katrina in August 2005. Qualitative data were analysed using grounded theory methodology. Five themes emerged as the most significant barriers to recovery: housing; transportation; employment; physical and mental health; and accessing recovery services. While these barriers to recovery were probably common to most survivors of the disaster, the research results suggest that disability status enhanced the challenges that participants experienced in negotiating the recovery process and in acquiring resources that accommodated their disabilities. The findings indicate that, when disaster recovery services and resources did not accommodate the needs of individuals with disabilities, recovery was hindered. Recovery efforts should include building accessible infrastructure and services that will allow for participation by all.

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Disaster preparedness in a complex urban system: the case of Kathmandu Valley, Nepal (pages 411–431)
Samuel Carpenter and François Grünewald
Version of Record online: 17 NOV 2015 | DOI: 10.1111/

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Mental and social health in disasters: the Sphere standards and post-tsunami psychosocial interventions in Asia (pages 432–451)
Silja E.K. Henderson, Peter Elsass and Peter Berliner
Version of Record online: 17 NOV 2015 | DOI: 10.1111/disa.12159
disa.12164
Abstract
The primary objective of this paper is to examine and inform the mental health and psychosocial support standards of the 2011 edition of the Sphere Project’s Humanitarian Charter and Minimum Standards in Humanitarian Response. This is done through a qualitative analysis of internal evaluation documents, reflecting four long-term humanitarian psychosocial programmes in different countries in post-tsunami Asia. The analysis yielded three overall conclusions. First, the Sphere standards on mental health and psychosocial support generally are highly relevant to long-term psychosocial interventions after disasters such as the Indian Ocean tsunami of 26 December 2004, and their application in such settings may improve the quality of the response. Second, some of the standards in the current Sphere handbook may lack sufficient guidance to ensure the quality of humanitarian response required. Third, the long-term intervention approach poses specific challenges to programming, a problem that could be addressed by including additional guidance in the publication.

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Towards a natural disaster intervention and recovery framework (pages 494–517)
Peter M. Lawther
Version of Record online: 17 NOV 2015 | DOI: 10.1111/disa.12163

Eurosurveillance
Volume 21, Issue 23, 09 June 2016
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

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Editorials
Zika virus, the new kid on the block
by M Zambon

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Sexual transmission of Zika virus in an entirely asymptomatic couple returning from a Zika epidemic area, France, April 2016
by T Fréour, S Mirallié, B Hubert, C Splingart, P Barrière, M Maquart, I Leparc-Goffart

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Sexual transmission of Zika virus in Germany, April 2016
by C Frank, D Cadar, A Schlaphof, N Neddersen, S Günther, J Schmidt-Chanasit, D Tappe

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 11 June 2016]

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Debate
Addressing the impact of economic sanctions on Iranian drug shortages in the joint comprehensive plan of action: promoting access to medicines and health diplomacy
The U.S Congress initiated sanctions against Iran after the 1979 U.S. Embassy hostage crisis in Tehran, and since then the scope of multilateral sanctions imposed by the United States, the European Union, and …
Sogol Setayesh and Tim K. Mackey
Globalization and Health 2016 12:31
Published on: 8 June 2016

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Commentary
The Trans-Pacific Partnership Agreement and health: few gains, some losses, many risks
In early October 2015, 12 nations signed the Trans-Pacific Partnership Agreement (TPPA), promoted as a model ‘21st century’ trade and investment agreement that other countries would eventually join. There are gro…
Ronald Labonté, Ashley Schram and Arne Ruckert
Globalization and Health 2016 12:25
Published on: 6 June 2016