The Lancet
Nov 18, 2017 Volume 390 Number 10109 p2215-2324   e39-e40
http://www.thelancet.com/journals/lancet/issue/current

Health in humanitarian crises
Public health information in crisis-affected populations: a review of methods and their use for advocacy and action
Francesco Checchi, Abdihamid Warsame, Victoria Treacy-Wong, Jonathan Polonsky, Mark van Ommeren, Claudine Prudhon
Summary
Valid and timely information about various domains of public health underpins the effectiveness of humanitarian public health interventions in crises. However, obstacles including insecurity, insufficient resources and skills for data collection and analysis, and absence of validated methods combine to hamper the quantity and quality of public health information available to humanitarian responders. This paper, the second in a Series of four papers, reviews available methods to collect public health data pertaining to different domains of health and health services in crisis settings, including population size and composition, exposure to armed attacks, sexual and gender-based violence, food security and feeding practices, nutritional status, physical and mental health outcomes, public health service availability, coverage and effectiveness, and mortality. The paper also quantifies the availability of a minimal essential set of information in large armed conflict and natural disaster crises since 2010: we show that information was available and timely only in a small minority of cases. On the basis of this observation, we propose an agenda for methodological research and steps required to improve on the current use of available methods. This proposition includes setting up a dedicated interagency service for public health information and epidemiology in crises.

The Lancet
Nov 18, 2017 Volume 390 Number 10109 p2215-2324   e39-e40
http://www.thelancet.com/journals/lancet/issue/current

Health in humanitarian crises
Recurrent failings of medical humanitarianism: intractable, ignored, or just exaggerated?
Sandro Colombo, Enrico Pavignani
Summary
Humanitarian health workers operate in dangerous and uncertain contexts, in which mistakes and failures are common, often have severe consequences, and are regularly repeated, despite being documented by many reviews. This Series paper aims to discuss the failures of medical humanitarianism. We describe why some of these recurrent failings, which are often not identified until much later, seem intractable: they are so entrenched in humanitarian action that they cannot be addressed by simple technical fixes. We argue that relief health-care interventions should be contextualised. Perhaps medical humanitarianism deserves a better reputation than the one at times tarnished by unfair criticism, resulting from inapplicable guiding principles and unrealistic expectations. The present situation is not conducive to radical reforms of humanitarian medicine; complex crises multiply and no political, diplomatic, or military solutions are in sight. Relief agencies have to compete for financial resources that do not increase at the same pace as health needs. Avoiding the repetition of failures requires recognising previous mistakes and addressing them through different policies by donors, stronger documentation and analysis of humanitarian programmes and interventions, increased professionalisation, improved, opportunistic relationships with the media, and better ways of working together with local health stakeholders and through indigenous institutions.

New England Journal of Medicine
November 16, 2017  Vol. 377 No. 20
http://www.nejm.org/toc/nejm/medical-journal

Sounding Board
Data Sharing from Clinical Trials — A Research Funder’s Perspective
Robert Kiley, Tony Peatfield, Jennifer Hansen, and Fiona Reddington
N Engl J Med 2017; 377:1990-1992 November 16, 2017 DOI: 10.1056/NEJMsb1708278

The Wellcome Trust, the Medical Research Council, Cancer Research UK, and the Bill and Melinda Gates Foundation share a common vision for maximizing the value of data that are generated through the trials we fund. We are committed to ensuring that the data from published clinical trials can be accessed by researchers so they can validate key findings, stimulate further inquiry, and ultimately deliver lifesaving results.

The sharing of data during the outbreak of Ebola virus disease in West Africa that began in 2014 helped researchers to trace the origins of the final few cases and bring the epidemic under control.1 And the challenge organized by the Journal to encourage researchers to use data from the Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated the vast potential for those data to be reused to develop new applications and uncover new knowledge.2

The recent announcement by the International Committee of Medical Journal Editors (ICMJE) on data-sharing statements for clinical trials3 is a step in the right direction but falls short of realizing our vision. The ICMJE has not mandated data sharing as a requirement for publication, and we find the example statements it provides to be vague and open to interpretation. Crucially, the requirements do not recognize that some research funders already have mandates for data sharing.

Policy
As funders of medical research, we recognize the importance of the appropriate sharing of clinical-trial data for reasons of transparency, good practice, and accelerated dissemination of results to the broader community. There is now a clear consensus that the results of all clinical trials must be reported in a timely manner, as set out in a joint statement by the World Health Organization regarding public disclosure of results from clinical trials.4 In addition, all our organizations have implemented data-sharing policies requiring that the data from studies we have funded will be made available to other researchers at the time of publication. This requirement applies equally to clinical trials.

These policies, however, do not mean that such data have to be openly available for anyone to access on the Web. We fully recognize that some data — and especially clinical-trial data — may contain sensitive, personal information about research participants, and these data need to be shared in a manner that protects participants’ privacy and confidentiality and respects the terms under which they consented to take part in the study. Such an approach might include the use of managed-access procedures, whereby requests to access data are reviewed by an independent committee, and of data-access agreements that place appropriate restrictions on how the data may be used.

As funders, we also recognize the many challenges to data sharing5 — most notably, those related to resources, equity, and incentives.

Resources
Sharing data is not a cost-free activity. Data need to be collected, preserved, curated, and stored in standardized formats in order to be useful to the scientific community. We need to support technical solutions that enable researchers to easily discover, access, and reuse the data in order to reap the benefits of accelerating discovery, enabling research reproducibility, and preventing redundancy. In addition, funding bodies are increasingly requiring that researchers develop data-management plans as part of research proposals, and we support the justified costs of delivering these plans as an integral part of funding the research. We anticipate that the data-sharing statements required by the ICMJE can, in part, be derived from researchers’ data-management-and-sharing plans.

Funders are actively working in partnership to support the development of community resources that facilitate access to clinical-trial data and reduce the burden on trialists. In particular, our organizations are planning to participate in the ClinicalStudyDataRequest.com platform,6 which currently includes trial data from 13 pharmaceutical companies, as a mechanism for listing and providing managed access to data from clinical trials that we have funded.

Equity
Particular concerns have been raised over the effect of more stringent requirements for sharing data from clinical trials that are conducted in low-income and middle-income countries — specifically, that requiring researchers in such countries to share data with better-resourced groups elsewhere may put them at an unfair disadvantage and that benefits will not necessarily be shared with the communities that participated in the research.

Our organizations are strongly committed to establishing trusted and equitable systems for data-access governance in these settings, which may include terms that require users to contribute to training and capacity development or to share the resulting outcomes. However, the fundamental requirement to ensure that data are accessible at the time of publication still holds firm.

Incentives
Arguably, the biggest challenge to data sharing is the sense that researchers are not given incentives to share data — and worse, many researchers believe they are disadvantaging themselves by doing so. A recent survey of Wellcome Trust–funded researchers showed that the potential loss of publication opportunities — along with the belief that publishing is the only currency for successful grant funding and academic advancement — was a key factor in the inhibition of data sharing.7

As funders, we need to tackle this issue head-on and demonstrate that we value the sharing of data — as well as other outputs, such as software and materials (e.g., antibodies, cell lines, and reagents) — and will take these outputs into account when reviewing grant and job applications. In parallel, we will make it clear that we focus on the scientific content of an article, rather than its publication metrics or the name of the journal in which it was published.
We commit to clearly communicating these values to the members of our grant-reviewing panels.

But we need to do more. The Wellcome Trust is reexamining its grant-application process to see how it can shift the emphasis from publications to a wider set of outputs. The Wellcome Innovator Awards program invites applicants to describe their key achievements and the significance in their field. These statements can be supported with reference to peer-reviewed articles, but also with other research outputs, such as patents, data sets, software, and materials.8 Such a model could be applied more broadly. Asking applicants to explain how they support the values of open research — transparency, reproducibility, and early access to results — is also worthy of consideration.9

More broadly, there is a need to support and foster community-wide efforts in this realm. Such efforts include accelerating the uptake of consistent approaches for data citation that allow the use of data to be acknowledged and tracked. The recently announced initiative exploring the value of awarding “data authorship” to researchers whose data are used or reused is also one we are following with interest.10

Conclusions
Medical research saves lives, and as the challenges in our world continue to outweigh the resources, collaboration and cooperation among members of the global research community will be essential in maximizing the effect of funded research. It is simply unacceptable that the data from published clinical trials are not made available to researchers and used to their fullest potential to improve health.

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 18 November 2017]

Excess Mortality Related to Chikungunya Epidemics in the Context of Co-circulation of Other Arboviruses in Brazil
November 13, 2017 · Research Article
Introduction: Chikungunya is an emerging arbovirus that reached the Western Hemisphere at the end of 2013. Studies in the Indian Ocean and India suggest that passive surveillance systems cannot recognize many of deaths associated with chikungunya, which can be inferred by an increase in the overall mortality observed during chikungunya epidemics.
Objective: We assess the mortality associated with chikungunya epidemics in the most affected states in Brazil, from 2015 and 2016.
Methods: We studied the monthly mortality by age group, comparing a period without epidemics to a chikungunya epidemic period, which we defined arbitrarily as consecutive months with incidences of more than 50 cases/100,000 persons.
Results: We obtained official data from the National System of Reported Diseases (SINAN) and the Mortality Information System (SIM), both maintained by the Ministry of Health. We identified a significant increase in the all-cause mortality rate during chikungunya epidemics, while there was no similar mortality in the previous years, even during dengue epidemics. We estimated an excess of 4,505 deaths in Pernambuco during the chikungunya epidemics (47.9 per 100,000 persons).The most affected age groups were the elderly and those under 1 year of age, and the same pattern occurred in all the states.
Discussion: Further studies at other sites are needed to confirm the association between increased mortality and chikungunya epidemics indifferent age groups. If these findings are confirmed, it will be necessary to revise the guidelines to recognize the actual mortality associated with chikungunya and to improve therapeutic approaches and protective measures in the most vulnerable groups.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 18 November 2017)

Viewpoints
US Gulf Coast states: The rise of neglected tropical diseases in “flyover nation”
Peter J. Hotez, Sheila Jackson Lee
| published 16 Nov 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005744

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 18 November 2017)

Perspective
Evidence-based restructuring of health and social care
Aziz Sheikh
Perspective | published 14 Nov 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002426
Governments around the world are grappling with how to respond to the challenges resulting from the epidemiological transition. Of particular concern is the increasing number of people living—for several decades—with 1 or more non-communicable disorders. The policy focus is centred on moving care away from the expensive specialist-dominated hospital sector to more community-based longitudinal care. The United Kingdom’s 2012 Health and Social Care Act, which gave control in England for the commissioning of care to clinicians working through Clinical Commissioning Groups (CCGs), represents one of the most ambitious and costly policy experiments to date [1]. This had the aims of supporting local decision-making, promoting innovation, and focusing attention on public health measures which, it was anticipated, would result in reductions in the need for specialist outpatient appointments and hospitalisations. In this issue of PLOS Medicine, however, James Lopez Bernal and colleagues report the results of their study finding that these benefits were not realised and that the intervention may have been associated with increased referrals to specialists [2].

The need to restructure care
There is now across the world increasing policy interest in the need to restructure health and social care such that it is better suited to the needs of people living with long-term conditions. Although the emergence of the specialist hospital sector was an appropriate response to cater to the large numbers of people affected by life-threatening infectious disease epidemics, the burden of disease now predominantly arises from noncommunicable disorders. The use of hospitals as the mainstay of care for people living with long-term conditions is inconvenient for patients and an inefficient use of public resources.

The policy focus is therefore on seeing whether patients can be better managed in community care contexts where they can receive longitudinal care in close proximity to where they live, with an emphasis on supported self-management and coordination of care, and with a greater focus on population-based preventive care than is possible in hospital-dominated health systems [3].

Integrating health and social care
Bradley and Taylor’s investigations in The American Health Care Paradox threw into sharp relief the need to consider expenditure on both health and social care in order to understand the relationship between expenditure and health outcomes [4]. This analysis, which has been widely debated in health policy circles, has underscored the need to integrate health and social care budgets in order to maximise the potential for health gains; for example, modest investments in home adaptations and mobility aids may be the difference between an individual’s ability to manage independently and a prolonged hospital admission.

Although the need to integrate health and social care policy is now widely appreciated, achieving this has proven challenging. The United Kingdom’s 2012 Health and Social Care Act represents one of the most important policy experiments in this respect [1]. In essence, this has involved passing financial control of local National Health Service (NHS) budgets to general practitioners through CCGs who were charged with procuring services on behalf of their patients. The underpinning assumption was that needs assessment and provision of care are best managed by those who are locally grounded. The Act thus resulted in a major shift of control and resources from the hospital sector to those providing front-line care, but as demonstrated by Lopez Bernal et al., this did not translate into a reduction of hospitalisations and was associated with an increased number of specialist outpatient referrals [2].

Challenges to and opportunities for evidence-based policymaking
Health is largely won or lost on the basis of major health policy decisions, but these are seldom evaluated [5]. The reasons are complex, including the time and costs of undertaking such evaluations and the distinct possibility that they may reveal inconvenient truths. Politicians, especially those operating in liberal democracies such as the United Kingdom, are vulnerable to the effects of adverse publicity associated with what are often perceived as ‘failed’ government initiatives. These political challenges are real and not easily overcome until such time as there is a cross-party, longer-term approach to restructuring care.

More promising is that in many contexts it is now possible to exploit routinely collected data, thereby greatly reducing the time and costs of evaluating major policy initiatives on the restructuring of health and social care. This is well illustrated by the Lopez Bernal et al. study, which will have been undertaken much more rapidly and at a fraction of the cost of generating primary data [2]. As the United Kingdom’s data assets continue to mature, in addition to major recent government investments to make routine data more liquid—by improving access to and the ability to link data—and developing data science capacity, it will become possible to answer an increasing array of health policy questions within rapid timeframes at minimal costs. There is thus now, at least in the United Kingdom, the opportunity for a step-change in our ability to move towards evidence-based policymaking. What remains is the political maturity to see the value in such evaluations and, where necessary, iterate the policy approach in the light of their findings.
[References at title link above]
 
 

PLoS One
http://www.plosone.org/
Research Article

Vaccine effectiveness against laboratory-confirmed influenza hospitalizations among young children during the 2010-11 to 2013-14 influenza seasons in Ontario, Canada
Sarah A. Buchan, Hannah Chung, Michael A. Campitelli, Natasha S. Crowcroft, Jonathan B. Gubbay, Timothy Karnauchow, Kevin Katz, Allison J. McGeer, J. Dayre McNally, David Richardson, Susan E. Richardson, Laura C. Rosella, Andrew Simor, Marek Smieja, Dat Tran, George Zahariadis, Jeffrey C. Kwong
Research Article | published 17 Nov 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0187834

Public Health Reports
Volume 132, Issue 6, November/December 2017
http://phr.sagepub.com/content/current

Surgeon General’s Perspective
Charting the Course to End HIV Transmission in the United States
Sylvia Trent-Adams, PhD, RN, FAAN
RADM, US Public Health Service
Deputy Surgeon General
First Published September 21, 2017; pp. 603–605

Research
Ranking States on Coverage of Cancer-Preventing Vaccines Among Adolescents: The Influence of Imprecision
Anne R. Waldrop, MD, Jennifer L. Moss, PhD, Benmei Liu, PhD, Li Zhu, PhD
First Published August 30, 2017; pp. 627–636
Abstract
Objectives:
Identifying the best and worst states for coverage of cancer-preventing vaccines (hepatitis B [HepB] and human papillomavirus [HPV]) may guide public health officials in developing programs, such as promotion campaigns. However, acknowledging the imprecision of coverage and ranks is important for avoiding overinterpretation. The objective of this study was to examine states’ vaccination coverage and ranks, as well as the imprecision of these estimates, to inform public health decision making.
Methods:
We used data on coverage of HepB and HPV vaccines among adolescents aged 13-17 from the 2011-2015 National Immunization Survey-Teen (n = 103 729 from 50 US states and Washington, DC). We calculated coverage, 95% confidence intervals (CIs), and ranks for vaccination coverage in each state, and we generated simultaneous 95% CIs for ranks using a Monte Carlo method with 100 000 simulations.
Results:
Across years, HepB vaccination coverage was 92.2% (95% CI, 91.8%-92.5%; states’ range, 84.3% in West Virginia to 97.0% in Connecticut). HPV vaccination coverage was 57.4% (95% CI, 56.6%-58.2%; range, 41.8% in Kansas to 78.0% in Rhode Island) for girls and 31.0% (95% CI, 30.3%-31.8%; range, 19.0% in Utah to 59.3% in Rhode Island) for boys. States with the highest and lowest ranks generally had narrow 95% CIs; for example, Rhode Island was ranked first (95% CI, 1-1) and Kansas was ranked 51st (95% CI, 49-51) for girls’ HPV vaccination. However, states with intermediate ranks had wider and more imprecise 95% CIs; for example, New York was 26th for girls’ HPV vaccination coverage, but its 95% CI included ranks 18-35.
Conclusions:
States’ ranks of coverage of cancer-preventing vaccines were imprecise, especially for states in the middle of the range; thus, performance rankings presented without measures of imprecision could be overinterpreted. However, ranks can highlight high-performing and low-performing states to target for further research and vaccination promotion programming.

Science         
17 November 2017   Vol 358, Issue 6365
http://www.sciencemag.org/current.dtl

Policy Forum
Racing for academic glory and patents: Lessons from CRISPR
By Arti K. Rai, Robert Cook-Deegan
Science17 Nov 2017 : 874-876 Restricted Access
Overly broad patents must be reined in
Summary
The much-publicized dispute over patent rights to CRISPR-Cas9 gene-editing technology highlights tensions that have been percolating for almost four decades, since the U.S. Bayh-Dole Act of 1980 invoked patents as a mechanism for promoting commercialization of federally funded research. With the encouragement provided by Bayh-Dole, academic scientists and their research institutions now race in dual competitive domains: the quest for glory in academic research and in the patent sphere. Yet, a robust economic literature (1, 2) argues that races are often socially wasteful; the racing parties expend duplicative resources, in terms of both the research itself and the legal fees spent attempting to acquire patents, all in the pursuit of what may be a modest acceleration of invention. For CRISPR, and future races involving broadly useful technologies for which it may set a precedent, the relationship between these competitive domains needs to be parsed carefully. On the basis of legal maneuvers thus far, it appears that the litigants will try for broad rights; public benefit will depend on courts reining them in and, when broad patents slip through, on updating Bayh-Dole’s pro-commercialization safeguards with underused features of the Act.

Science         
17 November 2017   Vol 358, Issue 6365
http://www.sciencemag.org/current.dtl

Perspectives
Advancing dengue vaccine development
By Mark B. Feinberg, Rafi Ahmed
Science17 Nov 2017 : 865-866 Restricted Access
Insights into the natural history of dengue virus infection guide vaccine development
Summary
Dengue virus (DENV) is a member of the viral genus Flavivirus, which also includes yellow fever virus (YFV) and Zika virus (ZIKV). DENV infection is a major and growing global health threat: There are ∼400 million cases of infection, ∼500,000 hospitalizations, and ∼12,500 deaths now estimated to occur each year (1). Dengue represents the most common mosquito-borne disease in humans (1). A remarkable 50% of the world’s population now lives in regions where DENV transmission is manifest. Dengue is associated with a wide spectrum of clinical outcomes, ranging from mild febrile illnesses to dengue hemorrhagic fever to the most severe clinical presentation of dengue shock syndrome, which is characterized by profound systemic cytokine activation, vascular leakage, and shock—this carries a high risk of death. On page 929 of this issue, Katzelnick et al. (2) analyzed DENV infection outcome data gleaned from the long-term followup of a cohort of Nicaraguan children (2). They found that the risk of severe dengue disease upon subsequent DENV infection correlated with baseline DENV antibody concentrations (titers), which has implications for DENV vaccination approaches.

Science         
17 November 2017   Vol 358, Issue 6365
http://www.sciencemag.org/current.dtl

Reports
Antibody-dependent enhancement of severe dengue disease in humans
By Leah C. Katzelnick, Lionel Gresh, M. Elizabeth Halloran, Juan Carlos Mercado, Guillermina Kuan, Aubree Gordon, Angel Balmaseda, Eva Harris
Science17 Nov 2017 : 929-932 Full Access
A long-term Nicaraguan pediatric cohort reveals that a narrow range of preexisting antibody titers increases the risk of severe dengue disease.
Editor’s Summary
Too much or too little—better than some
Dengue fever is caused by a mosquito-transmitted flavivirus resembling Zika virus. Both viruses can cause severe diseases in humans with catastrophic sequelae. It has been suspected in humans, and shown in animal models, that the host’s immune responses can make disease worse. Katzelnick et al. examined data from a long-term study of Nicaraguan children exposed to dengue virus (see the Perspective by Feinberg and Ahmed). They confirmed that antibody-dependent enhancement of disease occurs at a specific range of antibody concentrations. Low levels of antibody did not enhance disease, intermediate levels exacerbated disease, and high antibody titers protected against severe disease. These findings have major implications for vaccines against flaviviruses. Indeed, recent vaccine trials have shown evidence of severe disease in some recipients who were previously exposed to virus.
Science, this issue p. 929; see also p. 865
Abstract
For dengue viruses 1 to 4 (DENV1-4), a specific range of antibody titer has been shown to enhance viral replication in vitro and severe disease in animal models. Although suspected, such antibody-dependent enhancement of severe disease has not been shown to occur in humans. Using multiple statistical approaches to study a long-term pediatric cohort in Nicaragua, we show that risk of severe dengue disease is highest within a narrow range of preexisting anti-DENV antibody titers. By contrast, we observe protection from all symptomatic dengue disease at high antibody titers. Thus, immune correlates of severe dengue must be evaluated separately from correlates of protection against symptomatic disease. These results have implications for studies of dengue pathogenesis and for vaccine development, because enhancement, not just lack of protection, is of concern.

Vaccine
Volume 35, Issue 48, Part A Pages 6469–6582 (4 December 2017)
http://www.sciencedirect.com/journal/vaccine/vol/35/issue/48/part/PA
Harmonising Immunisation Safety Assessment in Pregnancy – Part II

Safety assessment of immunization in pregnancy
Open access
Pages 6469–6471
Sonali Kochhar, Jorgen Bauwens, Jan Bonhoeffer, GAIA Project Participants
In pregnancy, immunological and physiological changes may increase a woman’s risk of infections and their sequelae. The immature immune system of the fetus and neonate pose an additional risk of infection and associated complications for the developing infant, including preterm birth [1,2]. In 2016, it was estimated that neonatal death accounted for approximately 45 percent of mortality among children less than five years of age [3]. Immunization in pregnancy has emerged as an important and successful public health intervention globally to reduce mortality and morbidity among pregnant women, their developing fetuses and neonates, and infants [4]. It may become a key strategy to address neonatal mortality in particular. This is particularly true in low and middle-income countries (LMIC) where the burden of vaccine-preventable diseases is the greatest and access to basic health services is limited.

An important aim of vaccinating pregnant women is to increase pathogen-specific antibodies in the mother to protect against some of the leading causes of morbidity in pregnant women [5]. Also, high and protective levels of immunoglobulin G may be transferred across the placenta from the vaccinated mother to the fetus [6]. This may reduce risk of transmitting infections to the infant and may also directly provide passive immunity early in life, which is a period of vulnerability for the infant [6]. The success of maternal tetanus vaccination demonstrates this principle and is part of routine care in many countries: 41 out of 59 countries achieved Maternal and Neonatal Tetanus (MNT) elimination as a result of the MNT Elimination programme in conjunction with the World Health Organization (WHO) and UNICEF [7]. Influenza and pertussis vaccines are being increasingly recommended as an integral part of immunization in pregnancy programs. These programs have demonstrated the feasibility and effectiveness of immunization in pregnancy programs in high, middle and low-income countries. New vaccines are being developed to prevent infections in pregnant women and infants, including against Group B streptococcus, respiratory syncytial virus, and cytomegalovirus [4].

Immunization in pregnancy is currently an underutilized strategy and public awareness and acceptance could be improved. Despite evidence for their safety and effectiveness in both mothers and their infants, vaccine uptake in pregnancy remains low for influenza and moderate for pertussis vaccine. The uptake of the influenza vaccine in pregnancy rarely exceeds 50 percent in developed countries, even in countries with national vaccination strategies in place. For example, 50 percent of women in the US were vaccinated against influenza just before or during pregnancy in the 2015–16 influenza season [8]. Influenza and pertussis vaccine uptake in pregnancy in England was around 42 percent and 60 percent, respectively in 2015–2016. The UK has among the highest coverage rates globally, indicating the scale of potential improvement [9]. The coverage of seasonal influenza vaccination in the 2014–15 influenza season in pregnant women in five EU Member States was between 0.3% and 56.1% (median 23.6%). No country achieved the EU target of 75 percent coverage among the risk groups) [10]. In LMIC, influenza vaccine coverage amongst pregnant women is negligible in 35 of the 64 tropical countries that recommend seasonal influenza vaccination for pregnant women [11].

Barriers to vaccination in pregnancy are complex and vary depending on the country and population. The safety of vaccines administered during pregnancy is a key consideration for pregnant women, healthcare providers, vaccine manufacturers, investigators, regulators, ethics committees and communities [4]. There is a need for a globally harmonised approach to actively monitor the safety of vaccines used in immunization programs for pregnant women [12].

Historically, there was little standardization of case definitions for adverse events following immunization (AEFI) [13]. This resulted in limited comparisons of safety data across vaccine trials and studies in pre- and post-licensure settings. The Brighton Collaboration (BC) was formed in 2000 to help to overcome this shortcoming [14]. Today, BC case definitions are used and recommended for use by normative bodies such as the World Health Organization (WHO), the US FDA, the European Medicines Agency, the US Centers for Disease Control and Prevention (CDC), and the European Centre for Disease Prevention and Control (ECDC) [15].

The GAIA (Global Alignment of Immunization Safety Assessment in Pregnancy) project (http://gaia-consortium.net), coordinated by the Brighton Collaboration Foundation (BCF) and funded by the Bill and Melinda Gates Foundation, was initiated in 2015 for an initial period of two years (2015–2016). This was a response to the World Health Organization’s call for a globally harmonised approach to actively monitor the safety of vaccines and immunization in pregnancy programs with a specific focus on LMIC needs and requirements [12]. In the GAIA project, experts from 13 organisations (BCF, US National Institute of Health, WHO, Global Healthcare Consulting, University of Washington, Baylor College of Medicine, Monash Institute of Medical Research, St. George’s University of London, Erasmus University Medical Center, Cincinnati Children’s Hospital, Public Health Agency Canada, Synapse Research Management Partners and International Alliance for Biological Standardization) collaborated with over 200 volunteers worldwide who participated in 25 specific working groups [16].

During the GAIA project, a global functional network of experts was created, bringing together experts in vaccinology, maternal health, and neonatology from academia, public health institutes, regulatory agencies, investigators and vaccine manufacturers from LMIC and high-income countries. GAIA outputs include a landscape analysis of available standards and guidance documents, comprising regulatory guidance pertinent to immunization in pregnancy from the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Conference on Harmonisation [4].

Further, GAIA has developed two guideline documents for a harmonised conduct of clinical trials of vaccines in pregnant women [17,18]. This includes recommendations for harmonised collection, analysis and presentation of safety data, provides guidance on the prioritisation and classification of data to be collected, as well as guidance on study design, applicable in various settings, including LMICs. The WHO Global Advisory Committee on Vaccine Safety (GACVS) provided a highly supportive assessment of the GAIA guidelines for clinical trials and considered them to be timely and useful [19]. These guidelines may also inform safety monitoring of vaccines already recommended for pregnant women (tetanus, influenza and pertussis).

The GAIA partners developed the first set of over 21 standardized case definitions of prioritized obstetric and neonatal outcomes based on the standard Brighton Collaboration process [20]. The first 10 definitions were published in a special issue of the journal Vaccine in December 2016. They comprise five obstetric (hypertensive disorders of pregnancy, maternal death, non-reassuring foetal status, pathways to preterm birth and postpartum haemorrhage) and five neonatal outcomes (congenital anomalies, neonatal death, neonatal infections, preterm birth and stillbirth) [21]. These were complemnted with definitions and assessment algorithms of enabling terms (e.g., gestational age).

Moreover, a searchable database of terms (glossary), concept definitions and ontology of over 3000 terms related to key events for monitoring immunization in pregnancy was developed (https://evs.nci.nih.gov/ftp1/GAIA/About.html). A map of disease codes across coding terminologies, including MedDRA and ICD, was created to enable pooling of data from various sources. An online tool for automated case classification (single case or batch classification) of events according to the standardized case definitions has also been developed [12].

An investigator workshop assessing the usefulness and applicability of GAIA guidelines and case definitions in clinical trials and observational studies in LMIC, and an internatonal consensus conference were held at the National Institute of Health (NIH) [22].

In this special issue, the next set of 11 case definitions including five obstetric outcomes (abortion, antenatal bleeding, gestational diabetes, dysfunctional labour, foetal growth retardation) and six neonatal outcomes (low birth weight, small for gestational age, neonatal encephalopathy, respiratory distress, failure to thrive and microcephaly) are published. In the light of the important public health benefit of immunization in pregnancy in particularly LMIC and the significant challenges of conducting research in low resource settings especially with pregnant women, the paper by Kochhar et al. highlights pertinent aspects of study design, regulatory and safety monitoring considerations in these settings.

The GAIA outputs are already being increasingly utilized in the field of immunization in pregnancy and maternal and child health by key stakeholders such as clinical trialists, investigators, regulators, and industry. Useful next steps would be monitoring the implementation of GAIA outputs and a structured assessment of their current field use in addition to systematic evaluation of GAIA output performance and the impact on data quality. This could guide refinement of tools, and updates of guidelines and case definitions in cyclical revision periods. A second way to stimulate scientific progress could be by developing additional guidelines and tools requested by investigators and key stakeholders, and establishing a central resource that may provide investigators and stakeholders with the standards and tools they need.

The GAIA guidelines, definitions and tools will be applicable in immunization in pregnancy pre-and post-licensure safety and pharmacovigilance surveillance systems and may help supporting enhanced surveillance and collection of safety data that can be consolidated and compared across sites, countries, and programs worldwide. A standardized approach to safety data collection and reporting is likely to improve the acceptability and implementation of immunizations in pregnancy and subsequently help reduce illness and death among pregnant women and infants globally.

Vaccine
Volume 35, Issue 48, Part A Pages 6469–6582 (4 December 2017)
http://www.sciencedirect.com/journal/vaccine/vol/35/issue/48/part/PA
Harmonising Immunisation Safety Assessment in Pregnancy – Part II

Research considerations
Immunization in pregnancy clinical research in low- and middle-income countries – Study design, regulatory and safety considerations
Open access
Pages 6575–6581
Sonali Kochhar, Jan Bonhoeffer, Christine E. Jones, Flor M. Muñoz, … Steven Hirschfeld
Abstract
Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally
 

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

EID Journal
Volume 23, Supplement—December 2017
Research
Centers for Disease Control and Prevention Public Health Response to Humanitarian Emergencies, 2007–2016
Andrew T. Boyd  , Susan T. Cookson, Mark Anderson, Oleg O. Bilukha, Muireann Brennan, Thomas Handzel, Colleen Hardy, Farah Husain, Barbara Lopes Cardozo, Carlos Navarro Colorado, Cyrus Shahpar, Leisel Talley, Michael Toole, and Michael Gerber
Author affiliations: Centers for Disease Control and Prevention Epidemic Intelligence Service, Atlanta, Georgia, USA (A.T. Boyd); Centers for Disease Control and Prevention, Atlanta (S.T. Cookson, M. Anderson, O.O. Bilukha, M. Brennan, T. Handzel, C. Hardy, F. Husain, B.L. Cardozo, C.N. Colorado, C. Shahpar, L. Talley, M. Gerber); Burnet Institute, Melbourne, Victoria, Australia (M. Toole)
Abstract
Humanitarian emergencies, including complex emergencies associated with fragile states or areas of conflict, affect millions of persons worldwide. Such emergencies threaten global health security and have complicated but predictable effects on public health. The Centers for Disease Control and Prevention (CDC) Emergency Response and Recovery Branch (ERRB) contributes to public health emergency responses by providing epidemiologic support for humanitarian health interventions. To capture the extent of this emergency response work for the past decade, we conducted a retrospective review of ERRB’s responses during 2007–2016. Responses were conducted across the world and in collaboration with national and international partners. Lessons from this work include the need to develop epidemiologic tools for use in resource-limited contexts, build local capacity for response and health systems recovery, and adapt responses to changing public health threats in fragile states. Through ERRB’s multisector expertise and ability to respond quickly, CDC guides humanitarian response to protect emergency-affected populations.

Media/Policy Watch

This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations 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.
 

New York Times
http://www.nytimes.com/
Accessed 18 November 2017
U.N. Pleads for End of Yemen Blockade or ‘Untold Thousands’ Will Die
The heads of three U.N. agencies urged the Saudi-led military coalition on Thursday to lift its blockade of Yemen, warning that “untold thousands” would die if it stayed in place.
November 17, 2017 – By REUTERS –
 
Washington Post
http://www.washingtonpost.com/
Accessed 18 November 2017
Vaccine Shortage Complicates Efforts To Quell Hepatitis A Outbreaks
Stephanie O’Neill | Kaiser Health News · National · Nov 14, 2017

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 Nov 2017

– 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.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

National Foundation for Infectious Diseases Announces Prestigious 2018 Award Recipients

BETHESDA, Md., Nov. 9, 2017 /PRNewswire-USNewswire/ — The National Foundation for Infectious Diseases (NFID) has selected Roger I. Glass, M.D., Ph.D., as recipient of the 2018 Jimmy and Rosalynn Carter Humanitarian Award, Kathryn M. Edwards, M.D., as recipient of the 2018 Maxwell Finland Award for Scientific Achievement and Anne Schuchat, M.D. (Rear Adm., U.S. Public Health Service), as recipient of the 2018 John P. Utz Leadership Award.

In recognition of his extraordinary contributions to public health over several decades and his outstanding leadership in research and vaccine policy which have helped to improve the health of children worldwide in the prevention of rotavirus, through the use of vaccines, NFID has selected Roger I. Glass, M.D., Ph.D., to receive the 2018 Jimmy and Rosalynn Carter Humanitarian Award.

“For three decades, Dr. Glass has been a global champion for research on rotavirus, the development of safe, effective and affordable rotavirus vaccines and for their inclusion in national programs for childhood immunization. Dr. Glass is not only an outstanding internationally recognized scientist but also a tireless advocate for health equity and delivery of the most effective vaccines to children throughout the world. Beyond these scientific and policy contributions, Dr. Glass has trained and mentored countless young investigators, many of whom are now in leadership positions worldwide. He has instilled in trainees a love for science, academic rigor and integrity, and a commitment to the public good,” said Mathuram Santosham, M.D., M.P.H., professor in the Department on International Health and Pediatrics at Johns Hopkins University.

In presenting the 2018 Maxwell Finland Award for Scientific Achievement, NFID recognizes Kathryn M. Edwards, M.D., as one of the world’s authorities on vaccinology, pediatric respiratory infections and pneumococcal disease. A member of the National Academy of Medicine, Dr. Edwards has made seminal discoveries in pediatric infectious diseases with work ranging from basic discovery, translational research, clinical trials and implementation. “Based on the myriad contributions to science that Dr. Edwards has made over her illustrious career, the tangible ways in which she has trained new generations of physicians and scientists, and the lasting impact her work will have, as well as her tireless dedication to the field, demonstrate how deeply deserving of this award she truly is. All who know her would echo my sentiment that she is one of the giants of pediatric infectious diseases,” said C. Buddy Creech, M.D., M.P.H., associate professor of Pediatrics in the Division of Pediatric Infectious Diseases at Vanderbilt University School of Medicine.

Anne Schuchat, M.D. (Rear Adm., U.S. Public Health Service), has been selected to receive the 2018 John P. Utz Leadership Award in recognition of her demonstrated skillful, unselfish leadership in trying times, including long-standing service to the Centers for Disease Control and Prevention and support to NFID. The award was established in honor of the late John P. Utz, M.D., one of the original founders of NFID.

The 2018 awards will be presented during the 45th anniversary of NFID, at the 2018 NFID Annual Awards Dinner on May 10, 2018 in Washington, D.C.

::::::

::::::

Milestones :: Perspectives

Editor’s Note:

We recognize the inherent limitations of high-level communiques from multilateral meetings such at the G7, etc. But we present excerpts from the communique issued at last week’s G7 Health Ministers meeting in Milan which represent, in our view, constructive recognition of some key issues. Full test of the communique available at title link.

  G7 Milan Health Ministers’ Communiqué  – 5-6 November, 2017

“United towards Global Health: common strategies for common challenges”

[9 pages; Editor’s excerpts/text bolding]

PREAMBLE

…

4. We recognize the importance of improving emergency preparedness, as well as crisis management and response, in cases of weather-related, and other disasters, epidemics and other health emergencies. In this respect, we welcome the consultation, led by the Italian Presidency and with international experts, providing science-based considerations to support informed decisions. We are determined to coordinate efforts, foster innovation, and share knowledge, information, and monitoring and foresight tools, to support the resilience of health systems and to protect the health of our populations. We underline the need to safeguard the protection of health workers and facilities during emergencies and in conflict-affected areas as provided by international humanitarian law.

5. In line with previous G7 and G20 commitments and the objectives set by the 2030 Agenda for Sustainable Development and its Sustainable Development Goals (SDGs), we reiterate the importance of strengthening health systems through each country’s path towards Universal Health Coverage (UHC), leaving no one behind, and of preventing health systems from collapsing during humanitarian and public health emergencies and effectively mitigating health crises. We will work together to implement the Sendai Framework for Disaster Risk Reduction. We seek to reduce global inequalities; to protect and improve the health of all individuals throughout their life course through inclusive health services; to tackle non-communicable diseases (NCDs); to sustain our commitments to eradicate polio through support to the Global Polio Eradication Initiative, and to end the epidemics of HIV/AIDS, malaria and tuberculosis by 2030 through the support to the Joint UN Programme on HIV/AIDS (UNAIDS), the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID; to support key global initiatives such as Gavi the Vaccine Alliance; and to invest in research and innovation important to global health.

6. As the world gets closer to achieving global polio eradication, we also recognize the importance of continuing our efforts to succeed and keep the world sustainably polio‐free, and, of the opportunity to leverage and transition polio assets and resources that have generated major and broader health benefits, including strengthened health systems.

7. We acknowledge the central leadership and coordinating role of WHO in country capacity building in preparing for and responding to public health emergencies, building resilient health systems, and the new strategic priority of WHO leadership to address the health impacts of climate and environmental factors. We acknowledge that WHO’s financial and human resource capacities have to be strengthened, including through adequate and sustainable funding of the WHO Emergency Programme and the Contingency Fund for Emergencies (CFE). We will explore supporting the World Bank’s Pandemic Emergency Financing Facility (PEF) and the WHO programme on environmental degradation and other determinants of health.

…

IMPACTS OF ENVIRONMENTAL FACTORS ON HEALTH

25. We welcome and support the provision of health services, particularly including immunization programs for migrants and refugees, including in situations of forced displacement and protracted crises, as well as the improvement of health services in transit and destination countries. This includes making immunization programs and clinical services available and accessible to everyone, while increasing the surveillance of infectious diseases and the monitoring of NCDs and their risk factors.

26. We will seek to improve access to physical and mental health services and assistance to migrants, refugees and crisis affected populations as appropriate. We will promote the identification, sharing, and adoption of good practices to address psychosocial needs of refugees and migrants. Following the adoption of the New York Declaration for Refugees and Migrants in September 2016, and the Resolution WHA 70.15 in May 2017, the support for migrants and refugees should consider their specific needs, leaving no one behind, in line with the 2030 Agenda for Sustainable Development.

…

GENDER PERSPECTIVE IN HEALTH POLICIES AND RIGHTS FOR WOMEN, CHILDREN AND ADOLESCENTS

31. We invite the OECD to benchmark mental health performance focusing specifically on adolescents. We condemn sexual and gender-based violence that impacts women and girls across the globe. We need to demonstrate our commitment and our leadership in addressing sexual and gender‐based violence, including harmful practices such as child, early and forced marriage, and female genital mutilation, in line with SDG 5.2 and 5.3, and human trafficking, including for the purpose of sexual exploitation.

32. We will support and empower women’s, children’s and adolescents’ voices, and meaningful participation through our policy, advocacy and programmatic engagement on health and nutrition and actively involve also men and boys as agents of change.

33. We will seek to invest in their education, improving their health literacy, skills, and capacities, including children and adolescents’ gender and diversity-sensitive sexuality education, programmes, and tools.

…

ANTIMICROBIAL RESISTANCE

39. We will promote R&D for new antimicrobials, alternative therapies, vaccines and rapid-point-of care diagnostics, in particular for WHO-defined priority pathogens and tuberculosis. We endeavor to preserve the existing therapeutic options. We see at this as a first step towards the acceleration of political commitments and urgent coordination, we look forward to the report to the United Nations General Assembly on AMR and the High Level Meeting on Tuberculosis in 2018.

…

CONCLUSIONS

43. We recognize the urgent need to build political momentum on the importance of addressing the impacts of environmental degradation and other factors on health and coordinated action for strengthening health systems, in line with aid effectiveness principles. This includes addressing health workforce shortages and poor health financing by countries to achieve their goals of increasing access to health care. We welcome WHO, World Bank, UNICEF, and relevant partners, including OECD, joint action for supporting countries to achieve SDG 3.8, and look forward to the progress reported at the UHC Forum 2017 next month in Tokyo.

44. We acknowledge the particular challenges of delivering health services in fragile states and conflict‐affected areas, where health systems are often compromised and ill-equipped to respond. Moreover, medical personnel and facilities in areas of conflict are increasingly under attack. Highlighting UN Security Council Resolution 2286 (2016) and UN General Assembly Resolution A RES/69/132 and UNGA 71/129, we strongly condemn violence, attacks, and threats directed against medical personnel and facilities, which have long term consequences for the civilian population and the healthcare systems of the countries concerned, as well as for the neighbouring regions. We therefore commit to improving their safety and security by upholding International Humanitarian Law.

45. We reiterate our commitment to build our International Health Regulations (IHR) core capacities and to assist 76 partner countries and regions to do the same. We also recognize the importance of developing national plans to address critical health security gaps as notably identified using the WHO’s Joint External Evaluation tool. We call on all countries to make specific commitments to support full implementation of the IHR and recognize their compliance with IHR as essential for efficient global health crisis prevention and management. We encourage other countries and development partners to join these collective efforts.

…

Yemen

Geneva Palais Briefing Note: The impact of the closure of all air, land and sea ports of Yemen on children
This is a summary of what was said by Meritxell Relano, UNICEF Representative in Yemen – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.
[Editor’s text bolding]
GENEVA, 10 November 2017 – Yemen is facing the largest humanitarian crisis and the worst food crisis in the world. Nearly 7 million people do not know where their next meal will come from and the survival of millions of people depends on humanitarian assistance operations.  You have all seen the statements from the humanitarian community in Yemen and from the Emergency Relief Coordinator based on his last visit on the ground. Fuel, medicines and food are essential in this context. And in order to get them in, we need access.

ACCESS
The recent closure of the Yemen’s airspace, sea and land ports has worsened the already shrinking space for the lifesaving humanitarian work. It is blocking the delivery of vital humanitarian assistance to children in desperate need in Yemen. And it is making a catastrophic situation for children far worse. The port of Hodeida is where most of the humanitarian supplies enter and it is essential that the port resumes its activity.

Also, because missions on the ground are not possible, blocking the movement of humanitarian workers and supplies, this means that millions of children will be deprived of lifesaving humanitarian assistance.

IMPACT
Let me give you some examples of the impact of the closure of the entry points to the country:
The current stocks of fuel will only last until the end of November. We need fuel to maintain health centers open and water systems functioning (both for distributing water and for treating used water). The price of existing fuel has increased by 60%.
If fuel stocks are not replenished:
:: UNICEF’s ongoing WASH response to respond to the cholera outbreak is likely to be affected. This could impact nearly 6 million people living in cholera high-risk districts.
:: The operating water supply systems and waste water treatment plants will stop functioning, causing unimaginable risks.
:: The functionality and mobility of the Rapid Response Teams, serving nearly half a million every week, will be hindered.
:: Due to shortage of fuel supply, 22 Governorates/District cold rooms/district vaccine stores are at a major risk of being shut down. Vaccines for thousands of children could be damaged.
If vaccines are blocked from reaching Yemen, at least 1 million children under the age of one will be at risk of diseases including polio and measles:
…The current stock of vaccines in the country will last 1 month
…Shortage of medical supplies will only worsen the Diphtheria outbreak recently reported in five districts of Ibb. About 87 suspected cases were reported with nine associated deaths.
With more than 60 per cent of population food insecure, the closure of the Yemen’s airspace, sea and land ports will lead to more deterioration in food security level which will worsen malnutrition rates.
Children are suffering from severe malnutrition and diseases that could be easily prevented. Children need urgent care and any disruption in bringing in therapeutic nutrition supplies will only mean that more children in Yemen will die.
UNICEF calls on all parties to the conflict in Yemen to allow and facilitate safe, sustainable, rapid and unhindered humanitarian access to all children and families in need, through land, air and sea.
 
::::::
 
WHO warns that more people will die if ports in Yemen do not reopen to humanitarian aid
Statement
9 November 2017 | GENEVA – For the fourth consecutive day, WHO’s operations in Yemen have been severely hampered due to the closure of all land, sea and air ports.

“WHO and the other humanitarian agencies need immediate and unhindered humanitarian access to Yemen”, said WHO Executive Director for Emergencies Dr Peter Salama. “The country is still facing the world’s largest cholera outbreak and 7 million people are on the brink of famine, including some two million severely malnourished children. If we can’t bring food and medical supplies into Yemen we will not be able to save people’s lives.”

WHO’s supplies are critically low. On Wednesday, WHO was prevented from delivering 250 tonnes of medical supplies via sea. The supply ship could not leave Djibouti as previously planned because of the closure of Yemen’s Al-Hudaydah’s port. The ship was carrying surgical kits, anaesthesia machines, infant incubator sets, water purification tablets and other essential supplies.

“We are particularly worried with the low stock of trauma kits”, said WHO representative in Yemen, Dr Nevio Zagaria. “We have enough for 2,000 surgeries but because of the escalating conflict we have treated hundreds of trauma patients in the last few weeks alone. If the hostilities continue and the ports remain closed, we will not be able to perform life-saving surgeries or provide basic health care.”

The closure of the ports will also affect the response to the cholera outbreak. As of 5 November, a total of 908,400 suspected cases and 2192 deaths have been reported since 27 April 2017 in 22 of 23 governorates. “We have made progress and there have been fewer deaths from cholera but we will suffer a major setback if we don’t have full access to all affected areas”, said Dr Zagaria.

Providing emergency health services and supporting partners in Yemen is a top priority for WHO. So far in 2017, WHO has provided 1500 tonnes of medicines and supplies. WHO-supported mobile medical teams have provided 21,443 consultations. WHO-supported surgical teams have conducted 9300 surgical interventions.
 

Bangladesh – Measles Immunization
 
Bangladesh steps up vaccination for new Rohingya arrivals as measles cases rise

Joint press release

COX’S BAZAR, Bangladesh, 10 November 2017 – An increase in the number of suspected measles cases among the newly arrived Rohingya and their host communities in southern Bangladesh has prompted the Government and UN partners to step up immunization efforts in overcrowded camps and makeshift shelters close to the border with Myanmar.

Nearly 360 000 people in the age group of six months to 15 years among the new Rohingya arrivals in Cox’s Bazar and their host communities, irrespective of their immunization status, would be administered measles and rubella vaccine through fixed health facilities, outreach vaccination teams, and at entry points into Bangladesh.

Measles, a childhood killer disease which can be particularly dangerous among unimmunized and malnourished children, is one of the major health risks among the over 611,000 people who have crossed over to Bangladesh from Myanmar since late August and are now living in cramped and insanitary conditions in Cox’s Bazar district.

As of 4 November, one death and 412 suspected cases of measles have been reported among the vulnerable populations living in camps, settlements, and among the host communities in Cox’s Bazar. Of them, 352 cases are from Ukhia and 46 from Teknaf sub-districts, and 11 have been reported from the district hospital. Majority of cases – 398 – are among the new arrivals and 14 among the host communities. As many as 82% cases are among children under five years of age.

“Children are especially at risk from outbreaks of measles and other communicable diseases that result from the crowded living conditions, malnutrition and severe lack of water and sanitation in the camps and other sites,” said Edouard Beigbeder, UNICEF Bangladesh Representative. “To halt any wider outbreak, it’s essential that coordinated efforts begin immediately to protect as many children as possible.”

With the risk of measles being high during such health emergencies, Ministry of Health and Family Welfare (MoHFW), with support of WHO, UNICEF and other local partners, was quick to roll out a measles and rubella (MR) vaccination campaign, between 16 September and 4 October, within weeks of the start of the recent influx of Rohingyas from Myanmar. Nearly 136,000 children between six months and 15 years were administered MR vaccine. Additionally, around 72,000 children up to five years of age were given bivalent oral polio vaccine (bOPV) and a dose of Vitamin A to help prevent measles related complication. The number of new arrivals has increased since the MR campaign, which also had challenges reaching out to all children in view of movement of people within the camps and settlements.

“As part of stepped up vaccination efforts, 43 fixed health facility sites, 56 outreach vaccination teams and vaccination teams at main border entry points will administer MR vaccine to population aged six months to 15 years, along with oral polio vaccine to children under five years and TT vaccine to pregnant women. These efforts are aimed at protecting and preventing the spread of measles among the vulnerable population,” WHO Representative to Bangladesh, Dr N Paranietharan, said.

More than 70 vaccinators from government and partners have been trained to deliver routine vaccination though fixed sites and outreach teams beginning tomorrow, while vaccination at entry points at Subrang, Teknaf, is ongoing since 1 November.

The fixed sites and outreach teams will also cover under two year olds with vaccines available in Bangladesh EPI schedule, such as BCG, pentavalent vaccine, oral polio vaccine, pneumococcal vaccine and two doses of MR vaccine.

As an additional measure, resources to treat measles cases are being reinforced with the distribution of vitamin A supplements, antibiotics for pneumonia and Oral Rehydration Salt (ORS) for diarrhoea related to measles. To improve hygiene conditions among the refugee population, 3.2 million water purification tablets and a total of 18,418 hygiene kits have been distributed benefitting 92,090 people.

The current initiative is yet another massive vaccination drive being rolled out for the new arrivals from Myanmar and their host communities in Cox’s Bazar since 25 August this year.  After covering 136 000 people in the September- October MR campaign, MoHFW and partners administered 900 000 doses of oral cholera vaccine to these vulnerable populations in two phases. The first phase that started 10 October covered over 700 000 people aged one year and above – both the new arrivals and their host communities, while the second phase from 4 – 9 November provided an addition dose of OCV to 199,472 children between one and five years, for added protection and bOPV to 236,696 children under 5 years of age

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 1 November 2017 [GPEI]
:: Health Ministers at the G7 summit in Milan this week reaffirmed their commitment to polio eradication, recognising “the importance of continuing our efforts to succeed and keep the world sustainably polio-free”.
[See Milestones above for polio eradication reference]

:: Summary of newly-reported viruses this week:
…Afghanistan: One new wild poliovirus type 1 (WPV1) case, reported in Batikot district in Nangarhar province.
…Syria:  Ten new circulating vaccine derived poliovirus type 2 (cVDPV2) cases reported, eight in Mayadeen district, and two in Boukamal district, Deir Ez-Zor governorate. Four new cVDPV2 positive contacts reported, three in Mayadeen district, and one in Boukamal district, Deir Ez-Zor governorate.

::::::

Syria cVDPV2 outbreak situation report 21: 7 November 2017
Situation update 7 November 2017
:: Ten (10) new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported this week from Mayadeen and Boukamal districts, Deir Ez-Zor governorate. Isolates from some cases had been laboratory pending for some time. The most recent case (by date of onset) remains 25 August.
:: The total number of cVDPV2 cases is 63.
:: Inactivated polio vaccine (IPV) will be offered to children 2-23 months in areas of Damascus and Rural Damascus with large internally displaced populations in the upcoming subnational immunization days (SNIDs) targeting children under 5 with bivalent oral polio vaccine. The campaign is planned for 19 November.
:: 250,000 doses of IPV have arrived in Damascus, which will ensure a continuous supply of vaccine for routine immunization activities in coming months. Syria is finalizing planning for targeted vaccination with IPV and is finalizing a request for additional IPV vaccine for additional campaign activities in Hasakah, Aleppo, Damascus and Rural Damascus governorates.
:: The International Monitoring Board (the polio programmes highest independent review mechanism) met last week in London to assess progress towards global interruption of all poliovirus circulation. The IMB reviewed the quality of the Syrian outbreak response to date and will provide recommendations through its report on how Syria can strengthen its outbreak response activities in coming months.

::::::

Polio Eradication Hopes and Fears: What Next?
4 Nov, 201:
On the occasion of World Polio Day  
Heidi Larson, Ph.D. & Will Schulz, MSc,
[See Research/Commentary below for full text]
 
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WHO Grade 3 Emergencies  [to 11 November 2017]
The Syrian Arab Republic
:: Syria cVDPV2 outbreak situation report 21: 7 November 2017
 [See Polio above]

Yemen
[See UNICEF and WHO statements above in Milestones]

::::::
 
WHO Grade 2 Emergencies  [to 11 November 2017]
Myanmar
::  Mortality and Morbidity Weekly Bulletin(MMWB) Cox’s Bazar, Bangladesh Volume No 4: 05
November 2017

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::::::
 
UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: 8 Nov 2017  Syria: Flash update on recent events – 8 November 2017

Yemen 
:: 6 Nov 2017  Yemen Humanitarian Bulletin Issue 28 | 29 October 2017
:: Statement by the Humanitarian Coordinator for Yemen, Jamie Mcgoldrick, on Continued Violence Affecting Civilians in Yemen [EN/AR] Sana’a, 5 November 2017
 
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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
ROHINGYA CRISIS
:: ISCG Situation Update: Rohingya Refugee Crisis, Cox’s Bazar – 9 November 2017
613,000 new arrivals are reported as of 7 November, according to IOM Needs and Population Monitoring.
A note on methodology: The official situation report figures are tabulated using the IOM Needs and Population Monitoring Emergency Tracking. This exercise takes place each day by estimating new arrivals at the point of transit in and around different settlements. NPM reports figures three times a week to update the international community on influx.

::::::
::::::
 
Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO webpages for updates and key developments.

MERS-CoV [to 11 November 2017]
http://www.who.int/emergencies/mers-cov/en/
DONs
Middle East respiratory syndrome coronavirus (MERS-CoV) – Oman
10 November 2017
 
Yellow Fever  [to 11 November 2017]
http://www.who.int/csr/disease/yellowfev/en/
[See Milestone above]
 
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::::::
 
WHO & Regional Offices [to 11 November 2017]
Stop using antibiotics in healthy animals
7 November 2017 – To prevent the spread of antibiotic resistance, farmers and the food industry should stop using antibiotics to promote growth and prevent disease in healthy animals. Over-use and misuse of antibiotics contributes to the threat of antibiotic resistance. Sustained action across all sectors, including agriculture, is key to preventing the spread of antibiotic resistance.

Highlights
Facilitating access to paediatric treatment of Chagas disease
November 2017 – WHO and partners are working to make an essential antiparasitic medicine for treatment of Chagas disease widely accessible to children. Treatment with this medicine in the early stages of infection can cure the Chagas disease, but currently very few people are able to access diagnosis and treatment services.

WHO’s work on air pollution
November 2017 – From smog hanging over cities to smoke inside the home, air pollution poses a major threat to health and climate. The combined effects of ambient (outdoor) and household air pollution cause about 6.5 million premature deaths every year.

Triple drug therapy to accelerate elimination of lymphatic filariasis
November 2017 – WHO is recommending an alternative three-drug treatment to accelerate the global elimination of lymphatic filariasis, a disabling and disfiguring neglected tropical disease. The treatment, known as IDA, involves a combination of ivermectin, diethylcarbamazine citrate, and albendazole.
 
Evaluation of the election of the Director-General of WHO
November 2017 – The Sixty-fifth World Health Assembly decided, in resolution WHA65.15 (2012), that an evaluation, open to all Member States, will be conducted by the Executive Board within one year from the appointment of the next Director-General of WHO, to assess the efficacy of the revised process and methods for the election of the Director-General, in order to discuss any need for further enhancing fairness, transparency and equity among the Member States of the six regions of WHO.

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GIN October 2017 pdf, 2.23Mb 10 November 2017

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Weekly Epidemiological Record, 10 November 2017, vol. 92, 45 (pp. 681–700)
:: Progress report on the elimination of human onchocerciasis, 2016–2017
:: Country Immunization Information System Assessments (IISAs), in Kenya (2015) and Ghana (2016)

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: 10 November 2017  Botswana successfully concludes the IDSR national Training of Trainers (TOT) Workshop
:: Uganda and Kenya Hold Cross Border Meeting on Marburg Virus Disease 10 November 2017
:: Ghana celebrates World Mental Health Day
:: As Nigerian government Flags-off 2017/2018 Measles Vaccination Campaign, Kaduna state Governor’s children get vaccinated against measles disease.  09 November 2017
:: Mental health in the workplace: Commemoration of the World Mental Health Day in Swaziland
09 November 2017
:: Local Communities in Kween District Embrace Marburg Virus Disease Control Interventions
08 November 2017
:: Namibia’s ban on antibiotics in healthy animals drives meat exports  08 November 2017
:: Building capacity for reducing health inequalities: The Regional GER & SD Workshop kicks off in Tanzania  07 November 2017
:: South Sudan kick starts implementation of the 3rd Malaria Indicator Survey to assess progress in tackling the disease  07 November 2017
:: New Strategy Launched to Help Tackle Maternal, Child Deaths in Sierra Leone 06 November 2017

WHO Region of the Americas PAHO
:: Obesity, a key driver of diabetes (11/10/2017)

WHO South-East Asia Region SEARO
::  Bangladesh steps up vaccination for new Rohingya arrivals as measles cases rise  10 November 2017
[See Bangladesh in Emergencies above]

WHO European Region EURO
:: Meeting of European immunization programme managers offers innovative forum for exchange of ideas and experiences 09-11-2017
Over 170 immunization programme managers from 43 Member States of the WHO European Region came together on 24–27 October 2017 in Budva, Montenegro, for the biannual Immunization Programme Managers’ Meeting (PMM), organized by WHO/Europe. They focused on maintaining momentum towards the goals of the European Vaccine Action Plan (EVAP).
Participants received updates on the work of WHO and partners, informed WHO and each other about progress in their countries, and learned about innovative WHO projects to address ongoing challenges. The PMM covered many immunization-related topics using a variety of formats to ensure maximum information sharing and discussion…

:: New procedure to accredit regional non-State actors not in official relations with WHO to the WHO Regional Committee for Europe 08-11-2017
:: Ioannina becomes the first city in Greece to pilot integrated health and social services 08-11-2017
:: New studies of street food in Kyrgyzstan and Tajikistan show alarming levels of trans fat and salt 08-11-2017
:: Training supports Republic of Moldova and Ukraine in increasing access to lower-priced medicines 06-11-2017

WHO Western Pacific Region
:: Stop overuse and misuse of antibiotics: combat resistance  MANILA, 10 November 2017
 

CDC/ACIP [to 11 November 2017]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for November 9, 2017
Country Immunization Information System Assessments — Kenya, 2015 and Ghana, 2016
Countries wanting to strengthen their national immunization programs by creating data quality improvement plans now have a model, due to the new WHO and CDC method for immunization information system assessments (IISAs) which was recently used for assessments in Kenya and Ghana. The availability, quality, and use of immunization data are widely considered to be cornerstones of successful national immunization programs. In 2015 and 2016, immunization information system assessments (IISAs) were conducted in Kenya and Ghana using a new WHO and CDC assessment method designed to identify the root causes of immunization data quality problems and assist in the development of improvement plans. In Kenya, this resulted in national and county target-setting workshops, with goals of strengthening support for 17 targeted counties. In Ghana, public health officials are piloting changes to improve the managerial and supervision skills of sub-district staff. They are also incorporating data quality content into pre-professional coursework for health students and continuing education for facility staff.

Announcements

European Medicines Agency  [to 11 November 2017]
http://www.ema.europa.eu/ema/
10/11/2017
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7–9 November 2017

10/11/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
Ten medicines recommended for approval, including two orphans ..
 
 
FDA [to 11 November 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
November 08, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access

November 06, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks
 
 
Global Fund [to 11 November 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Malawi Accelerating Progress against HIV, TB and Malaria
09 November 2017
Malawi and the Global Fund strengthened their partnership by signing four grants today worth a total of US$460 million. The funds seek to expand interventions for HIV, tuberculosis and malaria, including efforts to reach more than 800,000 people in Malawi with treatment for HIV by 2020.

IFFIm
http://www.iffim.org/library/news/press-releases/
10 November 2017
IFFIm issues US$ 300 million in 3-year floating rate Vaccine Bonds
Funding to support immunisation of children in the poorest countries
London, 9 November 2017 – The International Finance Facility for Immunisation Company (IFFIm) today priced a US dollar floating rate benchmark bond issuance. The US$ 300 million, 3-year Vaccine Bonds provide investors an opportunity to fund immunisation programmes by Gavi, the Vaccine Alliance (Gavi), helping protect millions of children in the world’s poorest countries against preventable diseases.
This marks IFFIm’s first visit to the international US dollar benchmark market this year, and it re-establishes IFFIm as regular borrower in the market, following its US$ 500 million 3-year floating rate note issued in October 2016. Today’s issuance was lead managed by Citi, Crédit Agricole and Goldman Sachs International. The issue maturing on 16 November 2020 has a re-offer of 100% and carries a quarterly coupon of +13 basis points over the 3-month USD Libor rate.
IFFIm funds – approximately US$ 2.6 billion to-date — have accelerated delivery of vaccines, helping vaccinate 640 million children and saving more than nine million lives in communities across Africa and Asia. Gavi uses economies of scale to drive down the prices of vaccines for the world’s poorest countries. Gavi-supported countries pay less than US$ 40 for the full recommended course of 11 vaccines, compared with the U.S. market price of more than US$ 900.
“This transaction is yet another opportunity in IFFIm’s 11-year history for investors to put their money to work in support of Gavi’s efforts to increase access to life-saving vaccines in developing countries,” said IFFIm Board Chair René Karsenti. “IFFIm’s Vaccine Bonds are the consummate example of how investors can do good for the world, even as they do well with a solid investment.”…

 
MSF/Médecins Sans Frontières  [to 11 November 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Yemen: Saudi-Led Coalition Must Allow Access for Humanitarian Organizations
SANA’A, YEMEN/NEW YORK, NOVEMBER 8, 2017—The Saudi-led coalition has not allowed Doctors Without Borders/Médecins Sans Frontières (MSF) flights into Yemen for the past three days, directly hindering the organization’s ability to provide life-saving medical and humanitarian assistance to a population already in dire need.
MSF is calling on the Saudi-led coalition to immediately allow unhindered access so that humanitarian assistance can reach those most in need in Yemen.

Press release
DRC: Aid Urgently Needed in Rural Areas of Kasai
November 07, 2017
KINSHASA, DEMOCRATIC REPUBLIC OF CONGO—More aid is urgently needed in rural areas of Kasai province, Democratic Republic of Congo (DRC), as people come out of hiding a year after conflict flared in the region, according to the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).
Alarming levels of malnutrition among young children indicate the severity of this neglected crisis.
 
 
NIH  [to 11 November 2017]
http://www.nih.gov/news-events/news-releases
November 6, 2017
NIH awards to test ways to store, access, share, and compute on biomedical data in the cloud
— NIH Data Commons Pilot Phase to seek best practices for developing and managing a data commons.
 
 
PATH  [to 11 November 2017]
http://www.path.org/news/index.php
Announcement | November 06, 2017
PATH convenes global partners to improve access to safe oxygen delivery
Government delegations from nine countries will join industry leaders, financiers, and global health partners in Dubai from November 7-9

UNAIDS [to 11 November 2017]
http://www.unaids.org/en
Press release
UNAIDS launches 2017 World AIDS Day campaign—My Health, My Right
GENEVA, 6 November 2017—In the lead-up to World AIDS Day on 1 December, UNAIDS has launched this year’s World AIDS Day campaign. The campaign, My Health, My Right, focuses on the right to health and explores the challenges people around the world face in exercising their rights…

UNICEF  [to 11 November 2017]
https://www.unicef.org/media/
10 November 2017
Geneva Palais Briefing Note: The impact of the closure of all air, land and sea ports of Yemen on children
This is a summary of what was said by Meritxell Relano, UNICEF Representative in Yemen  – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.
[See Emergencies above for more detail]
 
Bangladesh steps up vaccination for new Rohingya arrivals as measles cases rise
COX’S BAZAR, Bangladesh, 10 November 2017 – An increase in the number of suspected measles cases among the newly arrived Rohingya and their host communities in southern Bangladesh has prompted the Government and UN partners to step up immunization efforts in overcrowded camps and makeshift shelters close to the border with Myanmar.
[See Emergencies above for more detail]

Wellcome Trust  [to 11 November 2017]
https://wellcome.ac.uk/news
News / Published: 8 November 2017
WHO changes guidance on averting maternal deaths after WOMAN trial results
The WHO has published new guidance strongly recommending that intravenous tranexamic acid (TXA) is given to women diagnosed with severe bleeding within three hours of them giving birth.
Bethan Hughes, from our Innovations team, explains how the WOMAN trial, which was co-funded by Wellcome, has prompted the new WHO guidelines.

::::::
 
November 9, 2017
New report and event examine the new era of vaccines
Vaccines play a vital role in protecting public health and preventing deadly disease.
For decades, vaccines and immunizations have played a critical role in protecting public health. A new report released today examines the integral value of vaccines in preventing the spread of illness and, in many places around the world, eliminating deadly infectious diseases. Smallpox has been eliminated and 16 diseases are now preventable in the United States as a result of childhood vaccines.
In order to develop vaccines, researchers must work together with stakeholders to overcome unique scientific, clinical and logistical challenges. America’s biopharmaceutical companies are committed to advancing a new era of both preventative and therapeutic vaccines for patients.      Our 2017 Medicines in Development: Vaccines update, released today, highlights the more than 260 vaccines in development to treat and prevent disease. These groundbreaking discoveries could alleviate the suffering of millions of people around the world…
Report: VACCINES: HARNESSING SCIENCE TO DRIVE INNOVATION FOR PATIENTS. 2017: 18 pages
PDF:  http://phrma-docs.phrma.org/files/dmfile/Vaccines_ReportLong_2017.pdf

 
Industry Watch  [to 11 November 2017]
:: One Year Later: Pfizer Update On Progress Of Humanitarian Assistance Program
6 November 2017

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

Vaccines: Accelerating Innovation and Access
Global Challenges Report – WIPO
Author(s): Hilde Stevens, Isabelle Huys, Koenraad Debackere, Michel Goldman, Philip Stevens, Richard T. Mahoney |
Publication year: 2017 : 32 pages
PDF: http://www.wipo.int/edocs/pubdocs/en/wipo_pub_gc_16.pdf
Abstract
This Global Challenges Report describes the innovation process for vaccines. It explains how the restricted availability of vaccines is due to impediments at every stage of the process. Most of these obstacles are manageable, and intellectual property (IP) rights are associated with only some of them. The analysis aims to put into perspective debates around health innovation and the availability of health technologies in developing countries, especially with respect to the role of IP. In particular, it provides an overview of how IP has been used to meet global health challenges in the vaccines field, and considers whether lessons can be drawn to inform other important health technologies.

The report proceeds as follows: Section 2, following the introduction, outlines the basic principles of vaccination, while also giving an overview of the history of vaccine research. Section 3 presents the social, economic, and health benefits of vaccines. Section 4 describes the research and development (R&D) process, identifying opportunities to accelerate progress. Section 5 examines the relevant regulatory pathway. Section 6 provides information about the challenges of vaccine manufacturing. Section 7 looks at national and international health systems for vaccine delivery. Section 8 examines how IP contributes to advances in vaccines and the availability of existing and future vaccines. Section 9 offers concluding remarks.

::::::

Polio Eradication Hopes and Fears: What Next?
Confidence Commentary: The Vaccine Confidence Project 
4 Nov, 201:
Heidi Larson, Ph.D. & Will Schulz, MSc
On the occasion of World Polio Day  
In August 1980, just three months after the World Health Assembly declared smallpox to be officially eradicated, D.A. Henderson stood up to address a gathering at the Fogarty Center in Washington D.C. His audience, flushed with the successful defeat of smallpox, had one question at the forefront of their minds: What next? Which disease, after smallpox, shall we eliminate utterly from the earth? His answer, tempered by 15 years in the difficult struggle that had just been won: There is none.

According to D.A., who passed away last year at the age of 87, smallpox was uniquely suited to eradication, since it had no animal reservoir, its vaccine was heat-stable, and its cases were detectable at a glance. Even so, he said, they had succeeded only by virtue of extraordinary performances by field staff, and a considerable amount of luck. There was no other disease currently within reach, he told his audience.

Of course, the idea of eradication lived on, and poliomyelitis was soon chosen as the next target. And, with phenomenal effort and a little bit of luck, we may finally be close to achieving it. We cannot be certain how soon – the legacy of missed deadlines creates doubt, as does the vexing problem of outright violence against vaccinators by the likes of Boko Haram and the Pakistani Taliban – but with case counts lower than ever before, and breakthroughs in the last holdouts of the virus, there is a palpable sense of anticipation in the air. The time has come, therefore, to begin planning our answer when the question is asked again, as it surely will be: What next?

We hope that when the global health community answers this question again, we will draw on the experience we have accrued over the decades of the polio programme. Most of all, we hope that we will be honest with ourselves as to the challenges – including the practical as well as political hurdles we will encounter. It is this clear-eyed ambition, not vapid optimism, that makes eradication unique and audacious. Eradication is inspiring precisely because we go into it with full knowledge of its difficulties, and acceptance – not denial – of its inherent uncertainties.

Only by heeding the hard lessons of the past can we avoid repeating old mistakes. D.A. knew, for example, that polio eradication would encounter its greatest challenges “in those areas of Africa and south Asia which all but thwarted global smallpox eradication.” (Henderson 1999, p. 21) Perhaps if his insights had been embraced early, rather than dismissed, polio would already be gone from the planet.

And yet, later in life, D.A. came to embrace polio eradication. He gave several reasons – Bill Gates’ financial commitment to the effort, for example, and the appointment of PAHO’s famed epidemiological miracle-worker, Dr. Ciro de Quadros, to lead it. However, there is also a deeper lesson we can learn from D.A.’s change of heart: The fact that a person so critical of eradication lent his support to it, in the end, should inspire us to always put forward our most constructive critiques, if we feel critiques are needed. Even the most sceptical people can contribute to the eradication effort, not dampening others’ hope, but enriching it with our accrued wisdom and knowledge of past pitfalls.

We hope that we will remember not only the problems polio has presented, but also the solutions it spurred us to invent, notably the unprecedented advances in: disease surveillance, mapping of remote settlements, tracking technologies for managing vaccination teams, and adaptive models for delivering vaccines in difficult political environments. Although technological advances may render some of these outmoded in time, the deeper insights – that recruiting local vaccinators increases public trust, for example – can be expected to endure.

Finally, we also hope that we will not forget the sacrifices made by health workers and volunteers, especially those who gave their lives to deliver vaccines to children in the most dangerous corners of the world. The success of eradication depends on a highly choreographed coalition of national and local government, non-government organizations, international agencies, pharmaceutical companies and research institutions, and perhaps most importantly, the commitment of local vaccinators and social mobilizers working long days, weeks, months and years in difficult situations. Success depends not on a single leader, but on a chorus of local, national and global leaders – from houses of worship to the halls of power, and many others in between. When polio is defeated and laurels are bestowed in Geneva, let us not forget the real heroes. When we plan the eradication of the next disease, we must make their safety and welfare an inviolable priority.

Eradication is, by its very nature, an uncertain enterprise. If for some reason polio eradication fails, this does not necessarily mean we should abandon it as a strategy for fighting infectious disease. Yet by the same token, if polio eradication succeeds, it is no guarantee that we will find success eradicating the next disease, which is sure to have new characteristics and present new obstacles. What we can take with us, though, are the lessons we have learned from polio. We have a duty, whether or not we intend to participate in the next eradication effort, to catalogue our experiences for the benefit of posterity. If the next eradication programme comes along in ten years or a hundred, we will give it the best possible chance of success by being clear and honest about the challenges we’ve faced.

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

Annals of Internal Medicine
7 November 2017 Vol: 167, Issue 9
http://annals.org/aim/issue

Do Less Harm: Evaluating HIV Programmatic Alternatives in Response to Cutbacks in Foreign Aid
Rochelle P. Walensky, MD, MPH; Ethan D. Borre, BA; Linda-Gail Bekker, MD, PhD; Emily P. Hyle, MD, MSc; Gregg S. Gonsalves, PhD; Robin Wood, MMed, DSc (Med); Serge P. Eholié, MD, MSc; Milton C. Weinstein, PhD; Xavier Anglaret, MD, PhD; Kenneth A. Freedberg, MD, MSc; A. David Paltiel, PhD, MBA
Abstract
Background:
Resource-limited nations must consider their response to potential contractions in international support for HIV programs.
Objective:
To evaluate the clinical, epidemiologic, and budgetary consequences of alternative HIV program scale-back strategies in 2 recipient nations, the Republic of South Africa (RSA) and Côte d’Ivoire (CI).
Design:
Model-based comparison between current standard (CD4 count at presentation of 0.260 × 109 cells/L, universal antiretroviral therapy [ART] eligibility, and 5-year retention rate of 84%) and scale-back alternatives, including reduced HIV detection, no ART or delayed initiation (when CD4 count is <0.350 × 109 cells/L), reduced investment in retention, and no viral load monitoring or second-line ART.
Data Sources:
Published RSA- and CI-specific estimates of the HIV care continuum, ART efficacy, and HIV-related costs.
Target Population:
HIV-infected persons, including future incident cases.
Time Horizon:
5 and 10 years.
Perspective:
Modified societal perspective, excluding time and productivity costs.
Outcome Measures:
HIV transmissions and deaths, years of life, and budgetary outlays (2015 U.S. dollars).
Results of Base-Case Analysis:
At 10 years, scale-back strategies increase projected HIV transmissions by 0.5% to 19.4% and deaths by 0.6% to 39.1%. Strategies can produce budgetary savings of up to 30% but no more. Compared with the current standard, nearly every scale-back strategy produces proportionally more HIV deaths (and transmissions, in RSA) than savings. When the least harmful and most efficient alternatives for achieving budget cuts of 10% to 20% are applied, every year of life lost will save roughly $900 in HIV-related outlays in RSA and $600 to $900 in CI.
Results of Sensitivity Analysis:
Scale-back programs, when combined, may result in clinical and budgetary synergies and offsets.
Limitation:
The magnitude and details of budget cuts are not yet known, nor is the degree to which other international partners might step in to restore budget shortfalls.
Conclusion:
Scaling back international aid to HIV programs will have severe adverse clinical consequences; for similar economic savings, certain programmatic scale-back choices result in less harm than others.
Primary Funding Source:
National Institutes of Health and Steve and Deborah Gorlin MGH Research Scholars Award.

Annals of Internal Medicine
7 November 2017 Vol: 167, Issue 9
http://annals.org/aim/issue

Ideas and Opinions
Yellow Fever Vaccine Shortages in the United States and Abroad: A Critical Issue
Daniel R. Lucey, MD, MPH; Halsie Donaldson, MS

BMJ Global Health
October 2017; volume 2, issue 4
http://gh.bmj.com/content/2/4?current-issue=y

Analysis
From blockchain technology to global health equity: can cryptocurrencies finance universal health coverage?
Brian M Till, Alexander W Peters, Salim Afshar, John Meara
November 10, 2017, 2 (4) e000570; DOI: 10.1136/bmjgh-2017-000570
Abstract
Blockchain technology and cryptocurrencies could remake global health financing and usher in an era global health equity and universal health coverage. We outline and provide examples for at least four important ways in which this potential disruption of traditional global health funding mechanisms could occur: universal access to financing through direct transactions without third parties; novel new multilateral financing mechanisms; increased security and reduced fraud and corruption; and the opportunity for open markets for healthcare data that drive discovery and innovation. We see these issues as a paramount to the delivery of healthcare worldwide and relevant for payers and providers of healthcare at state, national and global levels; for government and non-governmental organisations; and for global aid organisations, including the WHO, International Monetary Fund and World Bank Group.

BMJ Global Health
October 2017; volume 2, issue 4
http://gh.bmj.com/content/2/4?current-issue=y

Monitoring Sustainable Development Goal 3: how ready are the health information systems in low-income and middle-income countries?
Juliet Nabyonga-Orem
October 25, 2017, 2 (4) e000433; DOI: 10.1136/bmjgh-2017-000433
Abstract
Sustainable Development Goals (SDGs) present a broader scope and take a holistic multisectoral approach to development as opposed to the Millennium Development Goals (MDGs). While keeping the health MDG agenda, SDG3 embraces the growing challenge of non-communicable diseases and their risk factors. The broader scope of the SDG agenda, the need for a multisectoral approach and the emphasis on equity present monitoring challenges to health information systems of low-income and middle-income countries. The narrow scope and weaknesses in existing information systems, a multiplicity of data collection systems designed along disease programme and the lack of capacity for data analysis are among the limitations to be addressed. On the other hand, strong leadership and a comprehensive and longer-term approach to strengthening a unified health information system are beneficial. Strengthening country capacity to monitor SDGs will involve several actions: domestication of the SDG agenda through country-level planning and monitoring frameworks, prioritisation of interventions, indicators and setting country-specific targets. Equity stratifiers should be country specific in addressing policy concerns. The scope of existing information systems should be broadened in line with the SDG agenda monitoring requirements and strengthened to produce reliable data in a timely manner and capacity for data analysis and use of data built. Harnessing all available opportunities, emphasis should be on strengthening health sector as opposed to SDG3 monitoring. In this regard, information systems in related sectors and the private sector should be strengthened and data sharing institutionalised. Data are primarily needed to inform planning and decision-making beyond SGD3 reporting requirements.

BMJ Global Health
October 2017; volume 2, issue 4
http://gh.bmj.com/content/2/4?current-issue=y

Commentary
Fighting TB stigma: we need to apply lessons learnt from HIV activism
Amrita Daftary, Mike Frick, Nandita Venkatesan, Madhukar Pai
October 31, 2017, 2 (4) e000515; DOI: 10.1136/bmjgh-2017-000515
Research

BMJ Global Health
October 2017; volume 2, issue 4
http://gh.bmj.com/content/2/4?current-issue=y

Is governance, gross domestic product, inequality, population size or country surface area associated with coverage and equity of health interventions? Ecological analyses of cross-sectional surveys from 80 countries
To assess associations between national characteristics, including governance indicators, with a proxy for universal health coverage in reproductive, maternal, newborn and child health (RMNCH).
Fernando C Wehrmeister, Inácio Crochemore M da Silva, Aluisio J D Barros, Cesar G Victora
October 31, 2017, 2 (4) e000437; DOI: 10.1136/bmjgh-2017-000437

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 11 November 2017)

Research article
Role of mHealth applications for improving antenatal and postnatal care in low and middle income countries: a systematic review
From 1990 to 2015, the number of maternal deaths globally has dropped by 43%. Despite this, progress in attaining MDG 5 is not remarkable in LMICs. Only 52% of pregnant women in LMICs obtain WHO recommended minimum of four antenatal consultations and the coverage of postnatal care is relatively poor. In recent years, the increased cellphone penetration has brought the potential for mHealth to improve preventive maternal healthcare services. The objective of this review is to assess the effectiveness of mHealth solutions on a range of maternal health outcomes by categorizing the interventions according to the types of mHealth applications.Authors: Anam Feroz, Shagufta Perveen and Wafa Aftab
Citation: BMC Health Services Research 2017 17:704
Published on: 7 November 2017

 BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 November 2017)

Research article
No MERS-CoV but positive influenza viruses in returning Hajj pilgrims, China, 2013–2015
Authors: Xuezheng Ma, Fang Liu, Lijuan Liu, Liping Zhang, Mingzhu Lu, Abuduzhayier Abudukadeer, Lingbing Wang, Feng Tian, Wei Zhen, Pengfei Yang and Kongxin Hu
10 November 2017

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 11 November 2017)

Introduction
Introduction: reporting on updates in the scientific basis for the Lives Saved Tool (LiST)
Authors: Neff Walker and Ingrid K. Friberg
Citation: BMC Public Health 2017 17(Suppl 4):774
Published on: 7 November 2017

Research
Water, sanitation and hygiene interventions for acute childhood diarrhea: a systematic review to provide estimates for the Lives Saved Tool
In the Sustainable Development Goals (SDGs) era, there is growing recognition of the responsibilities of non-health sectors in improving the health of children. Interventions to improve access to clean water, …
Authors: Nazia Darvesh, Jai K. Das, Tyler Vaivada, Michelle F. Gaffey, Kumanan Rasanathan and Zulfiqar A. Bhutta
Citation: BMC Public Health 2017 17(Suppl 4):776
Published on: 7 November 2017

Research
How is the Lives Saved Tool (LiST) used in the global health community? Results of a mixed-methods LiST user study
The Lives Saved Tool (LiST) is a computer-based model that estimates the impact of scaling up key interventions to improve maternal, newborn and child health. Initially developed to inform the Lancet Child Surviv…
Authors: Angela R. Stegmuller, Andrew Self, Kate Litvin and Timothy Roberton
Citation: BMC Public Health 2017 17(Suppl 4):773
Published on: 7 November 2017

Research article
To vaccinate or not to vaccinate? Perspectives on HPV vaccination among girls, boys, and parents in the Netherlands: a Q-methodological study
Despite the introduction of Human papillomavirus (HPV) vaccination in national immunization programs (NIPs), vaccination rates in most countries remain relatively low. An understanding of the reasons underlyin…
Authors: Nathalie J. S. Patty, Hanna Maria van Dijk, Iris Wallenburg, Roland Bal, Theo J. M. Helmerhorst, Job van Exel and Jane Murray Cramm
Citation: BMC Public Health 2017 17:872
Published on: 7 November 2017

Research
A method for estimating maternal and newborn lives saved from health-related investments funded by the UK government Department for International Development using the Lives Saved Tool
In 2010, the UK Government Department for International Development (DFID) committed through its ‘Framework for results for reproductive, maternal and newborn health (RMNH)’ to save 50,000 maternal lives and 2…
Authors: Ingrid K. Friberg, Angela Baschieri and Jo Abbotts
Citation: BMC Public Health 2017 17(Suppl 4):779
Published on: 7 November 2017

Health Affairs
November 2017; Vol. 36, No. 11
http://content.healthaffairs.org/content/current

Issue Focus: Global Health Policy
Lower-Income Countries That Face The Most Rapid Shift In Noncommunicable Disease Burden Are Also The Least Prepared
Thomas J. Bollyky, Tara Templin, Matthew Cohen, and Joseph L. Dieleman

Research Article  Global Health Policy
Trends In The Alignment And Harmonization Of Reproductive, Maternal, Newborn, And Child Health Funding, 2008–13
Melisa Martinez-Alvarez, Arnab Acharya, Leonardo Arregoces, Lara Brearley,

Research Article  Global Health Policy
Nationwide Mortality Studies To Quantify Causes Of Death: Relevant Lessons From India’s Million Death Study
Mireille Gomes, Rehana Begum, Prabha Sati, Rajesh Dikshit, Prakash C. Gupta,

Research Article  Global Health Policy
Measuring The Impact Of Cash Transfers And Behavioral ‘Nudges’ On Maternity Care In Nairobi, Kenya
Jessica Cohen, Claire Rothschild, Ginger Golub, George N. Omondi, Margaret E. Kruk

Research Article  Global Health Policy
Accountable Care Reforms Improve Women’s And Children’s Health In Nepal
Duncan Maru, Sheela Maru, Isha Nirola, Jonathan Gonzalez-Smith, Andrea Thoumi,

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 11 November 2017]

Research
The many meanings of evidence: a comparative analysis of the forms and roles of evidence within three health policy processes in Cambodia
Helen Walls, Marco Liverani, Kannarath Chheng and Justin Parkhurst
Health Research Policy and Systems 2017 15:95
Published on: 10 November 2017
Abstract
Background
Discussions within the health community routinely emphasise the importance of evidence in informing policy formulation and implementation. Much of the support for the evidence-based policy movement draws from concern that policy decisions are often based on inadequate engagement with high-quality evidence. In many such discussions, evidence is treated as differing only in quality, and assumed to improve decisions if it can only be used more. In contrast, political science scholars have described this as an overly simplistic view of the policy-making process, noting that research ‘use’ can mean a variety of things and relies on nuanced aspects of political systems. An approach more in recognition of how policy-making systems operate in practice can be to consider how institutions and ideas influence which pieces of evidence appear to be relevant for, and are used within, different policy processes.
Methods
Drawing on in-depth interviews undertaken in 2015–2016 with key health sector stakeholders in Cambodia, we investigate the evidence perceived to be relevant to policy decisions for three contrasting health policy examples, namely tobacco control, HIV/AIDS and performance-based salary incentives. These cases allow us to examine the ways that policy-relevant evidence may differ given the framing of the issue and the broader institutional context in which evidence is considered.
Results
The three health issues show few similarities in how pieces of evidence were used in various aspects of policy-making, despite all being discussed within a broad policy environment in which evidence-based policy-making is rhetorically championed. Instead, we find that evidence use can be better understood by mapping how these health policy issues differ in terms of the issue characteristics, and also in terms of the stakeholders structurally established as having a dominant influence for each issue. Both of these have important implications for evidence use. Contrasting concerns of key stakeholders meant that evidence related to differing issues could be understood in terms of how it was relevant to policy. The stakeholders involved, however, could further be seen to possess differing logics about how to go about achieving their various outcomes – logics that could further help explain the differences seen in evidence utilisation.
Conclusion
A comparative approach reiterates that evidence is not a uniform concept for which more is obviously better, but rather illustrates how different constructions and pieces of evidence become relevant in relation to the features of specific health policy decisions. An institutional approach that considers the structural position of stakeholders with differing core goals or objectives, as well as their logics related to evidence utilisation, can further help to understand some of the complexities of evidence use in health policy-making.

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 11 November 2017]

Research
Institutional capacity to generate and use evidence in LMICs: current state and opportunities for HPSR
Evidence-informed decision-making for health is far from the norm, particularly in many low- and middle-income countries (LMICs). Health policy and systems research (HPSR) has an important role in providing the context-sensitive and -relevant evidence that is needed. However, there remain significant challenges both on the supply side, in terms of capacity for generation of policy-relevant knowledge such as HPSR, and on the demand side in terms of the demand for and use of evidence for policy decisions. This paper brings together elements from both sides to analyse institutional capacity for the generation of HPSR and the use of evidence (including HPSR) more broadly in LMICs.Zubin Cyrus Shroff, Dena Javadi, Lucy Gilson, Rockie Kang and Abdul Ghaffar
Health Research Policy and Systems 2017 15:94
Published on: 9 November 2017

Humanitarian Exchange Magazine
http://odihpn.org/magazine/the-humanitarian-consequences-of-violence-in-central-america/
Number 70   October 2017
Special Feature: The Lake Chad Basin: an overlooked crisis?

by Humanitarian Practice Network October 2017
The 70th edition of Humanitarian Exchange, co-edited with Joe Read, focuses on the humanitarian crisis in Nigeria and the Lake Chad Basin. The violence perpetrated by Boko Haram and the counter-insurgency campaign in Nigeria, Cameroon, Chad and Niger has created a humanitarian crisis affecting some 17 million people. Some 2.4 million have been displaced, the vast majority of them in north-eastern Nigeria. Many are living in desperate conditions, without access to sufficient food or clean water. The Nigerian government’s focus on defeating Boko Haram militarily, its reluctance to acknowledge the scale and gravity of the humanitarian crisis and the corresponding reticence of humanitarian leaders to challenge that position have combined to undermine the timeliness and effectiveness of the response…
[Reviewed earlier]

JAMA
November 7, 2017, Vol 318, No. 17, Pages 1625-1728
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Targeting Immune Checkpoints in Cancer Therapy
Suzanne L. Topalian, MD
JAMA. 2017;318(17):1647-1648. doi:10.1001/jama.2017.14155
This Viewpoint reviews the development of immune checkpoint inhibitors as a new drug class for treating cancer, and discusses future directions including development of commercial assays for identifying response-to-treatment biomarkers and the use of combination regimens to improve response.

Viewpoint
Vaccination Challenges in Confronting the Resurgent Threat From Yellow Fever
Lin H. Chen, MD; Davidson H. Hamer, MD
JAMA. 2017;318(17):1651-1652. doi:10.1001/jama.2017.14258
This Viewpoint examines strategies for vaccinating travelers against yellow fever given recent vaccine shortages and global yellow fever outbreaks.

Journal of Medical Microbiology
Volume 66, Issue 11, November 2017
http://jmm.microbiologyresearch.org/content/journal/jmm/66/11

Prevention and Therapy
Pertussis-associated persistent cough in previously vaccinated children
Nicola Principi, David Litt, Leonardo Terranova, Marina Picca, Concetta Malvaso, Cettina Vitale, Norman K. Fry, Susanna Esposito, the Italian Pertussis Group for Persistent Cough in Children
First Published Online: 06 October 2017, Journal of Medical Microbiology 66: 1699-1702, doi: 10.1099/jmm.0.000607

The Lancet
Nov 11, 2017 Volume 390 Number 10108 p2121-2214
http://www.thelancet.com/journals/lancet/issue/current

Editorial
The case for action on childhood pneumonia
The Lancet
Pneumonia kills almost 1 million children each year, and more than 80% of these deaths are children under 2 years of age. While not solely a disease of developing countries—it is the leading cause of child hospitalisation in the USA—it disproportionately affects children living with poverty or malnourishment who are the most vulnerable to infection. A key defence is immunisation, but over 25 million children under 2 years were not immunised with the pneumococcal conjugate vaccine in 2016. Available vaccines are produced by just two manufacturers and priced out of the reach of many countries, even with assistance from Gavi, which has immunised 109 million children against pneumococcal disease as of last year.

The core of the problem is neglect. Save the Children, in a report released on Nov 2, makes the case that pneumonia is a forgotten killer, and they are right. Despite collective support for Gavi, and WHO and UNICEF’s global plan of action for pneumonia and diarrhoea, no international initiative or campaign has yet spurred attention to the extent required. Pneumonia, despite being the leading cause of death among children, has never appeared on the agendas of the G8 or G20. As a result, the Sustainable Development Goal to eliminate preventable child deaths by 2030 will remain just an aspiration unless childhood pneumonia is vigorously addressed: the report estimates there will be 735 000 children dying from the disease in 2030 if action is not accelerated.

Save the Children’s new global campaign has the backing of former UN Secretary General Kofi Annan, who calls for pharmaceutical companies, donors, and UN agencies to come together and negotiate affordable vaccination. But vaccines are not enough, as the report concedes. Tackling pneumonia is achievable only with strong, efficient, and equitable health systems. This means action to support proper diagnosis and treatment of suspected cases, and to deliver vaccines via skilled health workers, cold storage chains, and well-governed procurement and delivery infrastructure. The case for saving children’s lives from pneumonia is clear—it will be realised only by strenghtening health systems.

The Lancet
Nov 11, 2017 Volume 390 Number 10108 p2121-2214
http://www.thelancet.com/journals/lancet/issue/current

Comment
Nine-valent human papillomavirus vaccine: great science, but will it save lives?
Lynette Denny
In The Lancet, Warner K Huh and colleagues1 report their final analysis of a randomised, double-blind trial of 14 215 women, aged 16–26 years, testing the quadrivalent human papillomavirus (qHPV; HPV types 6, 11, 16, and 18) vaccine compared with the nine-valent HPV (9vHPV; HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine. The women were recruited from 105 study sites located in 18 countries and received vaccination on day 1 and months 2 and 6. The 9vHPV vaccine consists of virus-like particles of HPV 6, 11, 16, and 18 (as found in the qHPV vaccine) and an additional five types, HPV 31, 33, 45, 52, and 58, combined with the adjuvant amorphous aluminium hydroxyphosphate sulphate.

The Lancet
Nov 11, 2017 Volume 390 Number 10108 p2121-2214
http://www.thelancet.com/journals/lancet/issue/current

Articles
Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: a randomised, double-blind trial
Warner K Huh, Elmar A Joura, Anna R Giuliano, Ole-Erik Iversen, Rosires Pereira de Andrade, Kevin A Ault, Deborah Bartholomew, Ramon M Cestero, Edison N Fedrizzi, Angelica L Hirschberg, Marie-Hélène Mayrand, Angela Maria Ruiz-Sternberg, Jack T Stapleton, Dorothy J Wiley, Alex Ferenczy, Robert Kurman, Brigitte M Ronnett, Mark H Stoler, Jack Cuzick, Suzanne M Garland, Susanne K Kjaer, Oliver M Bautista, Richard Haupt, Erin Moeller, Michael Ritter, Christine C Roberts, Christine Shields, Alain Luxembourg
Summary
Background
Primary analyses of a study in young women aged 16–26 years showed efficacy of the nine-valent human papillomavirus (9vHPV; HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine against infections and disease related to HPV 31, 33, 45, 52, and 58, and non-inferior HPV 6, 11, 16, and 18 antibody responses when compared with quadrivalent HPV (qHPV; HPV 6, 11, 16, and 18) vaccine. We aimed to report efficacy of the 9vHPV vaccine for up to 6 years following first administration and antibody responses over 5 years.
Methods
We undertook this randomised, double-blind, efficacy, immunogenicity, and safety study of the 9vHPV vaccine study at 105 study sites in 18 countries. Women aged 16–26 years old who were healthy, with no history of abnormal cervical cytology, no previous abnormal cervical biopsy results, and no more than four lifetime sexual partners were randomly assigned (1:1) by central randomisation and block sizes of 2 and 2 to receive three intramuscular injections over 6 months of 9vHPV or qHPV (control) vaccine. All participants, study investigators, and study site personnel, laboratory staff, members of the sponsor’s study team, and members of the adjudication pathology panel were masked to vaccination groups. The primary outcomes were incidence of high-grade cervical disease (cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, invasive cervical carcinoma), vulvar disease (vulvar intraepithelial neoplasia grade 2/3, vulvar cancer), and vaginal disease (vaginal intraepithelial neoplasia grade 2/3, vaginal cancer) related to HPV 31, 33, 45, 52, and 58 and non-inferiority (excluding a decrease of 1·5 times) of anti-HPV 6, 11, 16, and 18 geometric mean titres (GMT). Tissue samples were adjudicated for histopathology diagnosis and tested for HPV DNA. Serum antibody responses were assessed by competitive Luminex immunoassay. The primary evaluation of efficacy was a superiority analysis in the per-protocol efficacy population, supportive efficacy was analysed in the modified intention-to-treat population, and the primary evaluation of immunogenicity was a non-inferiority analysis. The trial is registered with ClinicalTrials.gov, number NCT00543543.
Findings
Between Sept 26, 2007, and Dec 18, 2009, we recruited and randomly assigned 14 215 participants to receive 9vHPV (n=7106) or qHPV (n=7109) vaccine. In the per-protocol population, the incidence of high-grade cervical, vulvar and vaginal disease related to HPV 31, 33, 45, 52, and 58 was 0·5 cases per 10 000 person-years in the 9vHPV and 19·0 cases per 10 000 person-years in the qHPV groups, representing 97·4% efficacy (95% CI 85·0–99·9). HPV 6, 11, 16, and 18 GMTs were non-inferior in the 9vHPV versus qHPV group from month 1 to 3 years after vaccination. No clinically meaningful differences in serious adverse events were noted between the study groups. 11 participants died during the study follow-up period (six in the 9vHPV vaccine group and five in the qHPV vaccine group); none of the deaths were considered vaccine-related.
Interpretation
The 9vHPV vaccine prevents infection, cytological abnormalities, high-grade lesions, and cervical procedures related to HPV 31, 33, 45, 52, and 58. Both the 9vHPV vaccine and qHPV vaccine had a similar immunogenicity profile with respect to HPV 6, 11, 16, and 18. Vaccine efficacy was sustained for up to 6 years. The 9vHPV vaccine could potentially provide broader coverage and prevent 90% of cervical cancer cases worldwide.
Funding
Merck & Co, Inc.

The Lancet
Nov 11, 2017 Volume 390 Number 10108 p2121-2214
http://www.thelancet.com/journals/lancet/issue/current

Articles
Mapping under-5 and neonatal mortality in Africa, 2000–15: a baseline analysis for the Sustainable Development Goals
Nick Golding, Roy Burstein, Joshua Longbottom, Annie J Browne, Nancy Fullman, Aaron Osgood-Zimmerman, Lucas Earl, Samir Bhatt, Ewan Cameron, Daniel C Casey, Laura Dwyer-Lindgren, Tamer H Farag, Abraham D Flaxman, Maya S Fraser, Peter W Gething, Harry S Gibson, Nicholas Graetz, L Kendall Krause, Xie Rachel Kulikoff, Stephen S Lim, Bonnie Mappin, Chloe Morozoff, Robert C Reiner Jr, Amber Sligar, David L Smith, Haidong Wang, Daniel J Weiss, Christopher J L Murray, Catherine L Moyes, Simon I Hay
Summary
Background
During the Millennium Development Goal (MDG) era, many countries in Africa achieved marked reductions in under-5 and neonatal mortality. Yet the pace of progress toward these goals substantially varied at the national level, demonstrating an essential need for tracking even more local trends in child mortality. With the adoption of the Sustainable Development Goals (SDGs) in 2015, which established ambitious targets for improving child survival by 2030, optimal intervention planning and targeting will require understanding of trends and rates of progress at a higher spatial resolution. In this study, we aimed to generate high-resolution estimates of under-5 and neonatal all-cause mortality across 46 countries in Africa.
Methods
We assembled 235 geographically resolved household survey and census data sources on child deaths to produce estimates of under-5 and neonatal mortality at a resolution of 5 × 5 km grid cells across 46 African countries for 2000, 2005, 2010, and 2015. We used a Bayesian geostatistical analytical framework to generate these estimates, and implemented predictive validity tests. In addition to reporting 5 × 5 km estimates, we also aggregated results obtained from these estimates into three different levels—national, and subnational administrative levels 1 and 2—to provide the full range of geospatial resolution that local, national, and global decision makers might require.
Findings
Amid improving child survival in Africa, there was substantial heterogeneity in absolute levels of under-5 and neonatal mortality in 2015, as well as the annualised rates of decline achieved from 2000 to 2015. Subnational areas in countries such as Botswana, Rwanda, and Ethiopia recorded some of the largest decreases in child mortality rates since 2000, positioning them well to achieve SDG targets by 2030 or earlier. Yet these places were the exception for Africa, since many areas, particularly in central and western Africa, must reduce under-5 mortality rates by at least 8·8% per year, between 2015 and 2030, to achieve the SDG 3.2 target for under-5 mortality by 2030.
Interpretation
In the absence of unprecedented political commitment, financial support, and medical advances, the viability of SDG 3.2 achievement in Africa is precarious at best. By producing under-5 and neonatal mortality rates at multiple levels of geospatial resolution over time, this study provides key information for decision makers to target interventions at populations in the greatest need. In an era when precision public health increasingly has the potential to transform the design, implementation, and impact of health programmes, our 5 × 5 km estimates of child mortality in Africa provide a baseline against which local, national, and global stakeholders can map the pathways for ending preventable child deaths by 2030.

Nature 
Volume 551 Number 7679 pp141-256  9 November 2017
http://www.nature.com/nature/current_issue.html

World View
Build the Ebola database in Africa
To build trust, capacity and utility, put local researchers in charge of planned platform, says Brian Conton.

When a weak, feverish person comes into a clinic in Africa, there is no quick, reliable way to know whether the illness is Ebola or one of many other diseases. This is in part why the Ebola epidemic in West Africa between 2014 and 2016 caused more than 11,000 deaths, overwhelmed infrastructure and brought so much loss.

This September, the Infectious Diseases Data Observatory (IDDO), a research network based at the University of Oxford, UK, held a meeting in Guinea to discuss plans for an information platform to share data obtained during the latest outbreaks, in hopes of improving responses in the future. It is now seeking further input on a collaborative research agenda. The team has promised to bring fellows from African institutions to work on the database and is assembling a steering group to set policies on who can access what data. The group will include representatives from countries that endured the outbreak as well as from research networks based in Africa.

The platform has yet to be established, and these preparatory efforts are well-intentioned. But in my opinion, having African scientists work on an information platform in another part of the world and at the behest of and under the jurisdiction of others does not confer the same benefits as working with local researchers to build our own tools on the ground.

As someone who has built one such database, I believe it would be more useful, and more equitable, to base the project in West Africa, at the front line of the battle against the virus. This will build capacity and trust. Once created, the platform should not become ‘helicopter research’, in which phenomena that occur in developing countries are studied for the benefit of foreign academic institutions. That often means that local scientists are not given authorship in publications. And worse, research can become skewed to fit the demands of Western academic careers, rather than solving the problems that the disease causes where it occurs.

During the outbreak, we had to treat people and do research at the same time. We had no vaccine and little to offer beyond rehydration. It took painful soul-searching to engage in studies while watching compatriots die. In my experience, some of the foreign institutions who came here to fight the outbreak had fewer compunctions. Even if they did not arrive with the goal of doing helicopter research, they quickly saw the need and the opportunity to gather data and patient samples. In some cases, this involved actions that would not happen in developed countries, such as unauthorized or poorly authorized taking of samples.
There were genuine reasons for circumventing bureaucracy: stocks of samples were building up that needed to be safely stored or destroyed. The outbreak countries did not have repositories of the right biosafety level to handle these. Nonetheless, many of us who lived through the outbreak feel that data and samples from our people were used with little regard for our countries’ or patients’ sovereignty.

Now that we are between outbreaks, we have a chance to get this right. Those who contribute data and labour must be convinced that the final output will be relevant and usable. No one working in a field hospital in the bush will be consulting a database for help with a diagnosis. The goal of collecting and curating data is to understand incidence, distribution, prevention and control of the disease. We need to know if we will have a sufficiently large population to categorize symptoms and the efficacy of treatments. Finally, African countries should be able to develop and benefit from the bioeconomy. We need a frank conversation about who has what rights to pass results to commercial entities and who will reap any financial benefits. Before a data platform is established and contributors of data are solicited, there must be a collaborative strategy that governs the generation of intellectual property and who will pay for analyses.

Critics of building the Ebola platform in West Africa will counter that the IDDO team, which is also working on platforms for malaria and visceral leishmaniasis, has better technical expertise and know-how. I believe local researchers have earned the right and demonstrated the capacity to lead this. Various teams including my own have already built platforms that track information from samples and medical records.

In my view, it is in the interest of science to build on these kinds of efforts rather than to assemble something new so far away. Our plan would be to function similarly to biobanks in the developed world, including charging fees to support our work. Storing samples and curating data are expensive. The only way to make either sustainable is to carefully integrate all the data with the sample.

Whatever data platform is built, I believe that researchers in Africa can and should be building and curating it. A credible African-led initiative could convince people that the outputs of the data platform would be relevant to and usable by them. This could ease collaborations. No individual source has all the data required — organizations and research institutions from several Western nations erected Ebola Treatment Units, where samples and data were taken. An African-led initiative has a legitimacy that a third party does not, even one as prestigious as Oxford.

It would also give us researchers in Africa a better chance of establishing true collaborations that build on and acknowledge the scientific capacity we have.
doi: 10.1038/d41586-017-05676-4

Nature Medicine
November 2017, Volume 23 No 11 pp1243-1384
http://www.nature.com/nm/journal/v23/n11/index.html

Articles
Defining total-body AIDS-virus burden with implications for curative strategies – pp1271 – 1276
Jacob D Estes, Cissy Kityo, Francis Ssali, Louise Swainson, Krystelle Nganou Makamdop, Gregory Q Del Prete, Steven G Deeks, Paul A Luciw, Jeffrey G Chipman, Gregory J Beilman, Torfi Hoskuldsson, Alexander Khoruts, Jodi Anderson, Claire Deleage, Jacob Jasurda, Thomas E Schmidt, Michael Hafertepe, Samuel P Callisto, Hope Pearson, Thomas Reimann, Jared Schuster, Jordan Schoephoerster, Peter Southern, Katherine Perkey, Liang Shang, Stephen W Wietgrefe, Courtney V Fletcher, Jeffrey D Lifson, Daniel C Douek, Joseph M McCune, Ashley T Haase & Timothy W Schacker
doi:10.1038/nm.4411
Quantifying the total-body virus burden in HIV-infected individuals is necessary to understand viral persistence and guide development of cure strategies. Here, Estes et al. find a high burden of residual virus in tissues of SIV-infected monkeys and HIV-infected humans, and evidence of low-level viral replication, even under antiretroviral therapy.

Pediatrics
November 2017, VOLUME 140 / ISSUE 5
http://pediatrics.aappublications.org/content/140/5?current-issue=y

Articles
Immunization, Antibiotic Use, and Pneumococcal Colonization Over a 15-Year Period
Grace M. Lee, Ken Kleinman, Stephen Pelton, Marc Lipsitch, Susan S. Huang, Matt Lakoma, Maya Dutta-Linn, Melisa Rett, William P. Hanage, Jonathan A. Finkelstein
Pediatrics Nov 2017, 140 (5) e20170001; DOI: 10.1542/peds.2017-0001
Immunization status and recent antibiotic use may influence individual risk for serotype-specific pneumococcal colonization.

Changes in Influenza Vaccination Rates After Withdrawal of Live Vaccine
Steve G. Robison, Aaron G. Dunn, Deborah L. Richards, Richard F. Leman
Pediatrics Nov 2017, 140 (5) e20170516; DOI: 10.1542/peds.2017-0516
Effects of the US withdrawal of the recommendation for use of LAIVs were assessed in a matched cohort of Oregon children.

Drinking Water to Prevent Postvaccination Presyncope in Adolescents: A Randomized Trial
Alex R. Kemper, Elizabeth D. Barnett, Emmanuel B. Walter, Christoph Hornik, Natalie Pierre-Joseph, Karen R. Broder, Michael Silverstein, Theresa Harrington
Pediatrics Nov 2017, 140 (5) e20170508; DOI: 10.1542/peds.2017-0508
This trial evaluates whether giving water to drink before vaccination decreases the risk of postvaccination presyncope and describes factors associated with postvaccination presyncope.

State-of-the-Art Review Article
Global Health: Preparation for Working in Resource-Limited Settings
Nicole E. St Clair, Michael B. Pitt, Sabrina Bakeera-Kitaka, Natalie McCall, Heather Lukolyo, Linda D. Arnold, Tobey Audcent, Maneesh Batra, Kevin Chan, Gabrielle A. Jacquet, Gordon E. Schutze, Sabrina Butteris, on behalf of the Global Health Task Force of the American Board of Pediatrics
Pediatrics Nov 2017, 140 (5) e20163783; DOI: 10.1542/peds.2016-3783
Abstract
Trainees and clinicians from high-income countries are increasingly engaging in global health (GH) efforts, particularly in resource-limited settings. Concomitantly, there is a growing demand for these individuals to be better prepared for the common challenges and controversies inherent in GH work. This is a state-of-the-art review article in which we outline what is known about the current scope of trainee and clinician involvement in GH experiences, highlight specific considerations and issues pertinent to GH engagement, and summarize preparation recommendations that have emerged from the literature. The article is focused primarily on short-term GH experiences, although much of the content is also pertinent to long-term work. Suggestions are made for the health care community to develop and implement widely endorsed preparation standards for trainees, clinicians, and organizations engaging in GH experiences and partnerships.

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 11 November 2017]

Enhancing Ebola Virus Disease Surveillance and Prevention in Counties Without Confirmed Cases in Rural Liberia: Experiences from Sinoe County During the Flare-up in Monrovia, April to June, 2016

November 9, 2017 · Research Article

Introduction: During the flare-ups of Ebola virus disease (EVD) in Liberia, Sinoe County reactivated the multi-sectorial EVD control strategy in order to be ready to respond to the eventual reintroduction of cases. This paper describes the impacts of the interventions implemented in Sinoe County during the last flare-up in Monrovia, from April 1 to June 9, 2016, using the resources provided during the original outbreak that ended a year ago.

Methods: We conducted a descriptive study to describe the key interventions implemented in Sinoe County, the capacity available, the implications for the reactivation of the multi-sectoral EVD control strategy, and the results of the same. We also conducted a cross-sectional study to analyze the impact of the interventions on the surveillance and on infection prevention and control (IPC).

Results: The attrition of the staff trained during the original outbreak was low, and most of the supplies, equipment, and infrastructure from the original outbreak remained available. With an additional USD 1755, improvements were observed in the IPC indicators of triage, which increased from a mean of 60% at the first assessment to 77% (P=0.002). Additionally, personnel/staff training improved from 78% to 89% (P=0.04). The percentage of EVD death alerts per expected deaths investigated increased from 26% to 63% (P<0.0001).

Discussion: The low attrition of the trained staff and the availability of most supplies, equipment, and infrastructure made the reactivation of the multi-sectoral EVD control strategy fast and affordable. The improvement of the EVD surveillance was possibly affected by the community engagement activities, awareness and mentoring of the health workers, and improved availability of clinicians in the facilities during the flare-up. The community engagement may contribute to the report of community-based events, specifically community deaths. The mentoring of the staff during the supportive supervisions also contributed to improve the IPC indicators.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 11 November 2017)

Perspective
Reaching global HIV/AIDS goals: What got us here, won’t get us there
Wafaa M. El-Sadr, Katherine Harripersaud, Miriam Rabkin
| published 07 Nov 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002421

Perspective
Measuring success: The challenge of social protection in helping eliminate tuberculosis
Priya B. Shete, David W. Dowdy
Perspective | published 07 Nov 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002419

Research Article
Comparison of two cash transfer strategies to prevent catastrophic costs for poor tuberculosis-affected households in low- and middle-income countries: An economic modelling study
William E. Rudgard, Carlton A. Evans, Sedona Sweeney, Tom Wingfield, Knut Lönnroth, Draurio Barreira, Delia Boccia
| published 07 Nov 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002418

PLoS One
http://www.plosone.org/
Research Article

Vaccination and nutritional status of children in Karawari, East Sepik Province, Papua New Guinea
Louis Samiak, Theophilus I. Emeto
Research Article | published 09 Nov 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0187796

Research Article
Epidemic spreading in multiplex networks influenced by opinion exchanges on vaccination
Lucila G. Alvarez-Zuzek, Cristian E. La Rocca, José R. Iglesias, Lidia A. Braunstein
Research Article | published 09 Nov 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0186492

Research Article
Perceptions and experiences of childhood vaccination communication strategies among caregivers and health workers in Nigeria: A qualitative study
Afiong Oku, Angela Oyo-Ita, Claire Glenton, Atle Fretheim, Heather Ames, Artur Muloliwa, Jessica Kaufman, Sophie Hill, Julie Cliff, Yuri Cartier, Eme Owoaje, Xavier Bosch-Capblanch, Gabriel Rada, Simon Lewin
Research Article | published 08 Nov 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0186733