WHO & Regionals [to 17 January 2015]

WHO & Regionals [to 17 January 2015]

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:: 136th WHO Executive Board session
26 January–3 February 2015 –
– Main Documents: http://apps.who.int/gb/e/e_eb136.html

:: Global Alert and Response (GAR): Disease Outbreak News (DONs)
– Middle East respiratory syndrome coronavirus (MERS-CoV) – Oman 16 January 2015
– Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 15 January 2015

:: The Weekly Epidemiological Record (WER) for 16 January 2015, vol. 90, 3 (pp. 9–16) includes:
– Detection of influenza virus subtype A by polymerase chain reaction: WHO external quality assessment programme summary analysis, 2014

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WHO Regional Offices
WHO African Region AFRO
Press Releases
:: Safe breastfeeding key to improve children’s health
Brazzaville, 12 January 2015 – Every day an estimated 8000 children die in sub-Saharan Africa from easily preventable or treatable illnesses. Breastfeeding is one of the best ways to provide newborns, infants and young children with the nutrients that they need while protecting them against conditions such as pneumonia, diarrhoea, and measles.

:: A Decade of WHO Action in the African Region: Striving together to achieve health goals [pdf1.27MB ]
By Luis Gomes Sambo, Regional Director 2005–2015
ISBN: 978 929 023 2551

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WHO Region of the Americas PAHO
:: Isabella Danel, former CDC official, sworn in as PAHO/WHO Deputy Director (01/16/2015)

:: PAHO/WHO honors Haitians and international relief workers on 5th anniversary of 2010 earthquake
Port-au-Prince, Haiti, 12 January 2015 (PAHO/WHO) – On the fifth anniversary of the earthquake that devastated Haiti on 12 January 2010, the Pan American Health Organization/World Health Organization (PAHO/WHO) honors the earthquake’s estimated 230,000 victims and their families and pays tribute to the many Haitian health workers and international relief workers for their dedication and outstanding efforts to bring relief to the disaster’s victims and survivors…

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WHO South-East Asia Region SEARO
No new digest content identified.

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WHO European Region EURO
:: Tajikistan introduces rotavirus vaccine to protect children from diarrhoeal disease
15-01-2015
With an official launch ceremony on 8 January 2015, Tajikistan became the fourteenth country in the WHO European Region to introduce rotavirus vaccination into its national immunization schedule, and the fourth to do so through the generous support of the GAVI Alliance.

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WHO Eastern Mediterranean Region EMRO
:: One Year Since the Last Case of Polio In Syria
Friday, January 16, 2015
Despite civil war and mass population displacement, incredible gains have been made against the polio outbreak in the Middle East.

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WHO Western Pacific Region
:: Update on the cluster of HIV cases, Roka Commune, Sang Ker District, Battambang Province
PHNOM PENH, 9 January 2015 – Between 8 to 31 December, 2014, a total of 1940 people from Roka Commune, voluntarily undertook HIV testing and counselling and 212 people tested positive for HIV. Among the people who tested HIV positive, 174 (82%) are from Roka Village. Among the total of 212 diagnoses, 39 people (18%) are 14 years old or younger, 127 (60%) are between 15 and 59 years old and 46 (22%) are 60 years old or older.
Read the joint news release

CDC/MMWR Watch [to 17 January 2015]

CDC/MMWR Watch [to 17 January 2015]
http://www.cdc.gov/media/index.html

:: Protection from Flu Vaccination Reduced this Season – Press Release – Thursday, January 15, 2015

:: Early Estimates of Seasonal Influenza Vaccine Effectiveness — United States, January 2015
Weekly – January 16, 2015 / 64(01);10-15
Brendan Flannery, PhD1, Jessie Clippard, MPH1, Richard K. Zimmerman, MD2, Mary Patricia Nowalk, PhD2, Michael L. Jackson, PhD3, Lisa A. Jackson, MD3, Arnold S. Monto, MD4, Joshua G. Petrie, MPH4, Huong Q. McLean, PhD5, Edward A. Belongia, MD5, Manjusha Gaglani, MBBS6, LaShondra Berman, MS1, Angie Foust, MA1, Wendy Sessions, MPH1, Swathi N. Thaker, PhD1, Sarah Spencer, PhD1, Alicia M. Fry, MD1 (Author affiliations at end of text)
In the United States, annual vaccination against seasonal influenza is recommended for all persons aged ≥6 months (1). Each season since 2004–05, CDC has estimated the effectiveness of seasonal influenza vaccine in preventing medically attended acute respiratory illness (ARI) associated with laboratory-confirmed influenza. This season, early estimates of influenza vaccine effectiveness are possible because of widespread, early circulation of influenza viruses.
By January 3, 2015, 46 states were experiencing widespread flu activity, with predominance of influenza A (H3N2) viruses (2). This report presents an initial estimate of seasonal influenza vaccine effectiveness at preventing laboratory-confirmed influenza virus infection associated with medically attended ARI based on data from 2,321 children and adults enrolled in the U.S. Influenza Vaccine Effectiveness Network (Flu VE) during November 10, 2014–January 2, 2015. During this period, overall vaccine effectiveness (VE) (adjusted for study site, age, sex, race/ethnicity, self-rated health, and days from illness onset to enrollment) against laboratory-confirmed influenza associated with medically attended ARI was 23% (95% confidence interval [CI] = 8%–36%). Most influenza infections were due to A (H3N2) viruses. This interim VE estimate is relatively low compared with previous seasons when circulating viruses and vaccine viruses were well-matched and likely reflects the fact that more than two-thirds of circulating A (H3N2) viruses are antigenically and genetically different (drifted) from the A (H3N2) vaccine component of 2014–15 Northern Hemisphere seasonal influenza vaccines (2). These early, low VE estimates underscore the need for ongoing influenza prevention and treatment measures.
CDC continues to recommend influenza vaccination because the vaccine can still prevent some infections with the currently circulating A (H3N2) viruses as well as other viruses that might circulate later in the season, including influenza B viruses. Even when VE is reduced, vaccination still prevents some illness and serious influenza-related complications, including thousands of hospitalizations and deaths (3). Persons aged ≥6 months who have not yet been vaccinated this season should be vaccinated, including persons who might already have been ill with influenza this season…

:: MMWR Weekly, January 16, 2015 / Vol. 64 / No. 1
– Early Estimates of Seasonal Influenza Vaccine Effectiveness — United States, January 2015
– Incidence of Notifiable Diseases Among American Indians/Alaska Natives — United States, 2007–2011
– Improving Burial Practices and Cemetery Management During an Ebola Virus Disease Epidemic — Sierra Leone, 2014
– Use of a Nationwide Call Center for Ebola Response and Monitoring During a 3-Day House-to-House Campaign — Sierra Leone, September 2014

Sabin Vaccine Institute Watch [to 17 January 2015]

Sabin Vaccine Institute Watch [to 17 January 2015]
http://www.sabin.org/updates/pressreleases

India Launches Massive Public Health Campaign to Eliminate Lymphatic Filariasis
WASHINGTON, D.C. — January 14, 2015 — India was certified polio-free in 2014. Today, the country has its sights set on another public health victory: the elimination of lymphatic filariasis, a neglected tropical disease (NTD) that threatens nearly half of its population. To meet this ambitious goal, the Indian Ministry of Health & Family Welfare (MOHFW) has launched one of the largest public health campaigns in India’s history to provide more than 400 million people with free medication that could protect them from lymphatic filariasis…

Clinical Infectious Diseases (CID) – Volume 60 Issue 3 February 1, 2015

Clinical Infectious Diseases (CID)
Volume 60 Issue 3 February 1, 2015
http://cid.oxfordjournals.org/content/current

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A Case-Control Study to Estimate the Effectiveness of Maternal Pertussis Vaccination in Protecting Newborn Infants in England and Wales, 2012–2013
Clin Infect Dis. (2015) 60 (3): 333-337 doi:10.1093/cid/ciu82
Gavin Dabrera, Gayatri Amirthalingam, Nick Andrews, Helen Campbell, Sonia Ribeiro, Edna Kara, Norman K. Fry, and Mary Ramsay
Abstract
This case-control study demonstrated that maternal pertussis vaccination was highly effective in preventing laboratory-confirmed pertussis infection in infants aged <2 months during a national pertussis outbreak in England and Wales

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Editorial Commentary: Tetanus-Diphtheria-Pertussis Immunization in Pregnant Women and the Prevention of Pertussis in Young Infants
James D. Cherry
Author Affiliations
Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles

A case-control study from England and Wales on the effectiveness of tetanus-diphtheria-pertussis (Tdap) immunization in pregnant women, authored by Dabrera et al in this issue of Clinical Infectious Diseases, supports the finding of a previous observational study done by the same group of investigators [1, 2]. As noted by the authors, a single dose of Tdap was recommended in the United Kingdom for pregnant women between 28 and 38 weeks’ gestation in October 2012. In the United States, the Advisory Committee on Immunization Practices (ACIP) made a similar recommendation in October 2011.

One aspect of the UK experience with Tdap vaccination of pregnant women is noteworthy—that in England and Wales, pregnant women typically receive care by general practitioners, and these same practitioners are routinely responsible for immunization of all their patients. The present study was carried out between 22 October 2012 and 11 July 2013. Therefore, it was conducted over a 9-month period that started just 3 weeks after Tdap was recommended for pregnant women. Nevertheless, approximately 64% of the pregnant women were vaccinated.

In contrast with the experience in England and Wales, the Tdap program in the United States is struggling, even though it was recommended a full year before the recommendation was made in the United Kingdom [3, 4]. Both Harriman and Winter [4] and Housey et al [3 …

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Risk Assessment for Healthcare Workers After a Sentinel Case of Rabies and Review of the Literature
Virginia L. Kan, Patrick Joyce, Debra Benator, Kathleen Agnes, Janet Gill, Monica Irmler, Arlene Clark, George Giannakos, Audrey Gabourel, and Fred M. Gordin
Clin Infect Dis. (2015) 60 (3): 341-348 doi:10.1093/cid/ciu850
Abstract
Although there has been no human-to-human transmission, fear of contagion after a rabies case represents a major concern for healthcare workers and requires rapid risk screening and counseling, as well as timely provision of postexposure prophylaxis for those with high-risk exposure.

Editorial – Cervical Cancer 2015 and Beyond: A Focus on Innovative Treatments and Attention to Survivorship

Clinical Therapeutics
January 2015 Volume 37, Issue 1, p1-242
http://www.clinicaltherapeutics.com/current

Editorial
Cervical Cancer 2015 and Beyond: A Focus on Innovative Treatments and Attention to Survivorship
Linda R. Duska
p6–8
Cervical cancer is primarily a disease of less-developed countries.1 In contrast, for countries with established screening programs and access to medical care, the number of cases of cervical cancer has declined significantly over the past few decades. With the introduction of human papillomavirus (HPV) testing/typing and increasing uptake of the HPV vaccine, it is anticipated that HPV-related cervical disease (both preinvasive and invasive) will ultimately become obsolete in developed countries.

The critical impact of time-to-pandemic uncertainty on pandemic cost-effectiveness analyses

Health Policy and Planning
Volume 30 Issue 1 February 2015
http://heapol.oxfordjournals.org/content/current

Buy now, saved later? The critical impact of time-to-pandemic uncertainty on pandemic cost-effectiveness analyses
Tom Drake1,2,3,*, Zaid Chalabi1 and Richard Coker1,4
Author Affiliations
1London School of Hygiene and Tropical Medicine, Kepple Street, London, WC1E 7HT, UK, 2Nuffield Department of Clinical Medicine, University of Oxford, Old Road Campus, Oxford, OX3 7BN, UK, 3Mahidol University Rajvithi Road, Bangkok 10400, Thailand and 4National University of Singapore, Lower Kent Ridge Road, Singapore 119077
Accepted November 21, 2013.
Abstract
Background Investment in pandemic preparedness is a long-term gamble, with the return on investment coming at an unknown point in the future. Many countries have chosen to stockpile key resources, and the number of pandemic economic evaluations has risen sharply since 2009. We assess the importance of uncertainty in time-to-pandemic (and associated discounting) in pandemic economic evaluation, a factor frequently neglected in the literature to-date.
Methods We use a probability tree model and Monte Carlo parameter sampling to consider the cost effectiveness of antiviral stockpiling in Cambodia under parameter uncertainty. Mean elasticity and mutual information (MI) are used to assess the importance of time-to-pandemic compared with other parameters. We also consider the sensitivity to choice of sampling distribution used to model time-to-pandemic uncertainty.
Results Time-to-pandemic and discount rate are the primary drivers of sensitivity and uncertainty in pandemic cost effectiveness models. Base case cost effectiveness of antiviral stockpiling ranged between is US$112 and US$3599 per DALY averted using historical pandemic intervals for time-to-pandemic. The mean elasticities for time-to-pandemic and discount rate were greater than all other parameters. Similarly, the MI scores for time to pandemic and discount rate were greater than other parameters. Time-to-pandemic and discount rate were key drivers of uncertainty in cost-effectiveness results regardless of time-to-pandemic sampling distribution choice.
Conclusions Time-to-pandemic assumptions can “substantially” affect cost-effectiveness results and, in our model, is a greater contributor to uncertainty in cost-effectiveness results than any other parameter. We strongly recommend that cost-effectiveness models include probabilistic analysis of time-to-pandemic uncertainty.

Journal of Medical Internet Research – Vol 17, No 1 (2015) January

Journal of Medical Internet Research
Vol 17, No 1 (2015): January
http://www.jmir.org/2015/1

Virtual Intervention to Support Self-Management of Antiretroviral Therapy Among People Living With HIV
José Côté, Gaston Godin, Pilar Ramirez-Garcia, Geneviève Rouleau, Anne Bourbonnais, Yann-Gaël Guéhéneuc, Cécile Tremblay, Joanne Otis
J Med Internet Res 2015 (Jan 06); 17(1):e6

Application of Mobile Technology for Improving Expanded Program on Immunization Among Highland Minority and Stateless Populations in Northern Thailand Border
Jaranit Kaewkungwal, Tawatchai Apidechkul, Kasemsak Jandee, Amnat Khamsiriwatchara, Saranath Lawpoolsri, Surasak Sawang, Aumnuyphan Sangvichean, Peerawat Wansatid, Sarinya Krongrungroj
JMIR mHealth uHealth 2015 (Jan 14); 3(1):e4

The Lancet – Jan 17, 2015

The Lancet
Jan 17, 2015 Volume 385 Number 9964 p201-302
http://www.thelancet.com/journals/lancet/issue/current

Comment
Is the world ready for an Ebola vaccine?
Bruce Y Lee, William J Moss, Lois Privor-Dumm, Dagna O Constenla, Maria D Knoll, Katherine L O’Brien
Summary
The west African Ebola epidemic has motivated efforts to bring an Ebola vaccine to the market as soon as possible. If a candidate vaccine successfully moves through clinical development, a product could be on the market in the next 1–2 years.1–6 Developing an efficacious vaccine will be only part of the process. Post-licensure challenges could impede and even derail an Ebola immunisation programme. We propose seven key challenges to be considered early in Ebola vaccine development that will help stakeholders prepare and allow developers to adjust vaccine characteristics accordingly.

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Comment
Towards evidence-based, quantitative Sustainable Development Goals for 2030
Børge Brende, Bent Høie
Open Access
DOI: http://dx.doi.org/10.1016/S0140-6736(14)61654-8
The success of the Millennium Development Goals (MDGs)1 on health has been due to their being easy to understand, ambitious, and achievable and, therefore, suitable for the purposes of advocacy and political mobilisation. The MDGs have brought quantitative targets and measurement of results—previously the domain of the scientific community—to centre stage for politicians worldwide. The three health MDGs (MDG 4, MDG 5, and MDG 6) have acted as a scorecard to measure progress on health, thus providing an empirical basis for the formulation of policy. For example, this scorecard has made it possible for Norwegian Prime Minister Erna Solberg and her colleagues in the MDG Advocacy Group to provide such strong advocacy for continued efforts to reach the MDGs before the deadline of 2015.

Work on the health MDGs has been based throughout on close collaboration between the scientific and political communities. Politicians have been able to convey documented progress towards the goals to the general public, and voters in both donor and recipient countries alike have been happy to support public funding for these efforts.

The world community is currently negotiating a new set of goals—the Sustainable Development Goals (SDGs)—for the post-2015 period. So far, 17 goals and 169 targets have been proposed by the Open Working Group.2 For politicians this number of goals is far too many. To win popular support for a comprehensive and coordinated effort for development, the goals must be easy to communicate. With regard to health, we have faced the additional challenge of combining three goals into one SDG, with an attempt to put the whole range of health issues under one coherent goal. This process, in turn, has contributed to the present “shopping list” of 13 targets within the Open Working Group proposal for a goal on health (SDG 3): “ensure healthy lives and promote well-being for all at all ages”.

Of course, it is politics that led to such a long list of health targets in the first place, but ultimately it is politics that has to resolve this situation. Politicians have to set priorities. We need a more limited set of goals and targets that are ambitious, easy to understand, and realistic. Importantly, measurement of progress towards the goals and targets must also be possible. To this end, we need contributions from the scientific community.

One plausible way forward is shown in a Lancet study by Ole Norheim and colleagues3 on quantification of the overarching 2030 SDG for health to avoid 40% of premature deaths in each country. In their review of mortality rates and trends in 25 countries, four country income groupings, and worldwide, Norheim and colleagues show that it is possible to consolidate targets in various areas, such as child health (MDG 4), maternal health (MDG 5), major infectious diseases (MDG 6), non-communicable diseases (NCDs), including mental health and injuries, and universal health coverage, under one universal and quantitative health goal. The simplicity of this approach is beautiful. Following this pattern, we could develop a tool to measure convergence in health globally, in line with the principle of universality to which we are all committed.

This approach seems to make sense from a scientific point of view as well. The proposal to set an overall indicator of avoiding 40% of premature deaths in each country is based on trends in mortality rates over the past 40 years and an estimate of what can be achieved by scaling up current cost-effective approaches. This quantification of a goal on health includes the major targets relating to MDGs 4, 5, and 6 and targets on NCDs proposed by the various communities, notably a 25% reduction in premature mortality from NCDs by 2025. This indicator is evidence based and ambitious yet achievable. It is, therefore, a good starting point for future political action and initiative.

Norheim and colleagues’ study3 shows what an important part science could play in the negotiations at the 69th Session of the UN General Assembly. We, therefore, strongly urge the medical community to consider the approach outlined by Norheim and colleagues3 and develop a common position that can enable us to arrive at a single health SDG with a limited number of simple, understandable, and measurable targets. We would also welcome similar approaches for other SDGs by the relevant communities.

We believe that the health SDG could provide the key framework for global health and prosperity. In anticipation of this framework, Norway is already taking concrete action. First, we are taking steps to improve public health in Norway. Our aim is to reduce NCDs, including mental disorders, by 25% by 2025. Second, Norway is working together with partner nations, the UN Secretary-General Ban Ki-moon, and World Bank President Jim Yong Kim to develop financial frameworks both for the current MDGs and for the future SDGs. Third, Norway is actively promoting projects that focus on both education and health, reflecting the aim of the SDG agenda of realising synergies between sectors.

Fourth, later in September, 2014, we will launch a national initiative called Vision 2030 to encourage researchers, commercial actors, civil society, and others to produce innovative ideas that could play a part in achieving the education and health SDGs both in Norway and abroad. Finally, together with partners in global health, Norway will explore ways to accelerate the deployment of innovations that are currently in the pipeline, and how investments can be catalysed to harness these innovations for promoting global health in the longer term.4
With so much left to do in the field of global health, by scientists as well as politicians, there is no time to lose. It is, therefore, vital that we all take action now.
BB is Norwegian Minister of Foreign Affairs. BH is Norwegian Minister of Health and Care Services.

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Comment
Quantifying targets for the SDG health goal
George Alleyne, Robert Beaglehole, Ruth Bonita
Open Access
DOI: http://dx.doi.org/10.1016/S0140-6736(14)61655-X
Summary
The Millennium Development Goals (MDGs) represent the best example of an international commitment to a set of normative principles underpinned by ideals of equity, solidarity, and peace.1,2 The goals achieved universal support because they were ambitious, included indicators that permitted measurement and accountability, and set 2015 for final reporting. The goals institutionalised poverty as multidimensional, and shaped development as beyond economics.3 Criticisms of the MDGs included the omission of many of the concerns of the Millennium Declaration, and the lack of adequate consultation on the process.

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Articles
Avoiding 40% of the premature deaths in each country, 2010–30: review of national mortality trends to help quantify the UN Sustainable Development Goal for health
Prof Ole F Norheim, PhD, Prof Prabhat Jha, DPhil, Kesetebirhan Admasu, MD, Tore Godal, MD, Ryan J Hum, MEng, Margaret E Kruk, MD, Octavio Gómez-Dantés, MD, Colin D Mathers, PhD, Hongchao Pan, PhD, Prof Jaime Sepúlveda, MD, Wilson Suraweera, MSc, Stéphane Verguet, PhD, Addis T Woldemariam, MD, Gavin Yamey, MD, Prof Dean T Jamison, PhD, Prof Richard Peto, FRS
Open Access
DOI: http://dx.doi.org/10.1016/S0140-6736(14)61591-9
Summary
Background
The UN will formulate ambitious Sustainable Development Goals for 2030, including one for health. Feasible goals with some quantifiable, measurable targets can influence governments. We propose, as a quatitative health target, “Avoid in each country 40% of premature deaths (under-70 deaths that would be seen in the 2030 population at 2010 death rates), and improve health care at all ages”. Targeting overall mortality and improved health care ignores no modifiable cause of death, nor any cause of disability that is treatable (or also causes many deaths). 40% fewer premature deaths would be important in all countries, but implies very different priorities in different populations. Reinforcing this target for overall mortality in each country are four global subtargets for 2030: avoid two-thirds of child and maternal deaths; two-thirds of tuberculosis, HIV, and malaria deaths; a third of premature deaths from non-communicable diseases (NCDs); and a third of those from other causes (other communicable diseases, undernutrition, and injuries). These challenging subtargets would halve under-50 deaths, avoid a third of the (mainly NCD) deaths at ages 50–69 years, and so avoid 40% of under-70 deaths. To help assess feasibility, we review mortality rates and trends in the 25 most populous countries, in four country income groupings, and worldwide.
Methods
UN sources yielded overall 1970–2010 mortality trends. WHO sources yielded cause-specific 2000–10 trends, standardised to country-specific 2030 populations; decreases per decade of 42% or 18% would yield 20-year reductions of two-thirds or a third.
Results
Throughout the world, except in countries where the effects of HIV or political disturbances predominated, mortality decreased substantially from 1970–2010, particularly in childhood. From 2000–10, under-70 age-standardised mortality rates decreased 19% (with the low-income and lower-middle-income countries having the greatest absolute gains). The proportional decreases per decade (2000–10) were: 34% at ages 0–4 years; 17% at ages 5–49 years; 15% at ages 50–69 years; 30% for communicable, perinatal, maternal, or nutritional causes; 14% for NCDs; and 13% for injuries (accident, suicide, or homicide).
Interpretation
Moderate acceleration of the 2000–10 proportional decreases in mortality could be feasible, achieving the targeted 2030 disease-specific reductions of two-thirds or a third. If achieved, these reductions avoid about 10 million of the 20 million deaths at ages 0–49 years that would be seen in 2030 at 2010 death rates, and about 17 million of the 41 million such deaths at ages 0–69 years. Such changes could be achievable by 2030, or soon afterwards, at least in areas free of war, other major effects of political disruption, or a major new epidemic.
Funding
UK Medical Research Council, Norwegian Agency for Development Cooperation, Centre for Global Health Research, and Bill & Melinda Gates Foundation.

The African Genome Variation Project shapes medical genetics in Africa

Nature
Volume 517 Number 7534 pp244-406 15 January 2015
http://www.nature.com/nature/current_issue.html

The African Genome Variation Project shapes medical genetics in Africa
Open
Deepti Gurdasani, Tommy Carstensen, Fasil Tekola-Ayele, Luca Pagani, Ioanna Tachmazidou
+ et al.
The African Genome Variation Project contains the whole-genome sequences of 320 individuals and dense genotypes on 1,481 individuals from sub-Saharan Africa; it enables the design and interpretation of genomic studies, with implications for finding disease loci and clues to human origins.

New England Journal of Medicine – January 15, 2015

New England Journal of Medicine
January 15, 2015 Vol. 372 No. 3
http://www.nejm.org/toc/nejm/medical-journal

Sharing Individual Patient Data from Clinical Trials
Jeffrey M. Drazen, M.D.
N Engl J Med 2015; 372:201-202January 15, 2015DOI: 10.1056/NEJMp1415160
Free Full Text, Audio, Comments

Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs
J.J. Darrow, A. Sarpatwari, J. Avorn, and A.S. Kesselheim
The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access.

Considerations on the Current Universal Vaccination Policy against Hepatitis A in Greece after Recent Outbreaks

PLoS One
[Accessed 17 January 2015]
http://www.plosone.org/

Considerations on the Current Universal Vaccination Policy against Hepatitis A in Greece after Recent Outbreaks
Kassiani Mellou, Theologia Sideroglou, Vassiliki Papaevangelou, Anna Katsiaflaka, Nikolaos Bitsolas, Eleni Verykouki, Eleni Triantafillou, Agoritsa Baka, Theano Georgakopoulou, Christos Hadjichristodoulou
Research Article | published 15 Jan 2015 | PLOS ONE 10.1371/journal.pone.0116939

The Ebola Epidemic: High hopes for Guinean vaccine trial

Science
16 January 2015 vol 347, issue 6219, pages 209-348
http://www.sciencemag.org/current.dtl

The Ebola Epidemic
High hopes for Guinean vaccine trial
Martin Enserink*
The push to test Ebola vaccines in the field is accelerating. Two candidates may go into phase III trials in a matter of weeks; a third one has just entered a phase I trial. Researchers have designed very different phase III studies for Liberia, Sierra Leone, and Guinea, the three countries with ongoing virus transmission. One problem they’re facing is that the number of new cases has dropped sharply in Liberia and is beginning to ebb in Sierra Leone. That’s why many scientists say Guinea—where researchers plan to try a highly unusual ring vaccination design—is the most promising testing ground.

Pediatricians’ Preferences for Infant Meningococcal Vaccination

Value in Health
January 2015 Volume 18, Issue 1, p1-136
http://www.valueinhealthjournal.com/current

Pediatricians’ Preferences for Infant Meningococcal Vaccination
Christine Poulos, PhD, F. Reed Johnson, PhD, Girishanthy Krishnarajah, MBA, MPH, Andrea Anonychuk, MSc, Derek Misurski, PhD
DOI: http://dx.doi.org/10.1016/j.jval.2014.10.010
Abstract
Background
Meningococcal disease is rare but can cause death or disabilities. Although the Advisory Committee on Immunization Practices has recommended meningococcal vaccination for at-risk children aged 9 through 23 months, it has not endorsed universal vaccination. Health insurance payments for the vaccination of children who are not at risk are likely to be limited. Use of infant meningococcal vaccines by these families will thus depend on the preferences of physicians who might recommend vaccination to parents, as well as parents’ preferences.
Objective
To quantify pediatricians’ preferences for specific features of hypothetical infant meningococcal vaccines.
Methods
A sample of pediatricians (n = 216) completed a Web-enabled, discrete choice experiment survey in which respondents chose between pairs of hypothetical vaccines in a series of trade-off questions. The questions described vaccines with six attributes. A random-parameters logit regression model was used to estimate the relative importance weights physicians place on vaccine features. These weights were used to calculate the predicted probability that a physician chooses hypothetical vaccines with given characteristics.
Results
Pediatricians’ choices indicated that increases in vaccine effectiveness were among the most important factors in their vaccine recommendations, followed by increases in the number of injections. The age at which protection begins and the number of additional office visits were less important. Whether a booster was required after 5 years was the least important factor in vaccine recommendations. The results suggest that virtually all (99.9%) physicians in the sample would recommend a vaccine even with the least-preferred features rather than no infant meningococcal vaccine.
Conclusions
Physicians’ responses indicate a strong preference for infant meningococcal vaccination.

From Google Scholar+ [to 17 January 2015]

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

Revista de Saude Publica
Oct 2014; 48(6): 906–915.
doi: 10.1590/S0034-8910.2014048005284
Factors associated with vaccination coverage in children< 5 years in Angola
Manuel Falcão Saturnino de Oliveira, I Edson Zangiacomi Martinez, II and Juan Stuardo Yazlle Rocha
Abstract
OBJECTIVE
To analyze vaccination coverage and factors associated with a complete immunization scheme in children < 5 years old.
METHODS
This cross-sectional household census survey evaluated 1,209 children < 5 years old living in Bom Jesus, Angola, in 2010. Data were obtained from interviews, questionnaires, child immunization histories, and maternal health histories. The statistical analysis used generalized linear models, in which the dependent variable followed a binary distribution (vaccinated, unvaccinated) and the association function was logarithmic and had the children’s individual, familial, and socioeconomic factors as independent variables.
RESULTS
Vaccination coverage was 37.0%, higher in children < 1 year (55.0%) and heterogeneous across neighborhoods; 52.0% of children of both sexes had no immunization records. The prevalence rate of vaccination significantly varied according to child age, mother’s level of education, family size, ownership of household appliances, and destination of domestic waste.
CONCLUSIONS
Vulnerable groups with vaccination coverage below recommended levels continue to be present. Some factors indicate inequalities that represent barriers to full immunization, indicating the need to implement more equitable policies. The knowledge of these factors contributes to planning immunization promotion measures that focus on the most vulnerable groups.

Media/Policy Watch [to 17 January 2015]

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

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

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Forbes
http://www.forbes.com/
Accessed 17 January 2015
Gates Foundation CEO: “History Is Going To Judge Us”
Sue Desmond-Hellmann took the helm at The Bill & Melinda Gates Foundation last May. She talks about what she’s hoping to change and how working in Uganda informs what she does now.
Kerry A. Dolan, Forbes Staff Jan 16, 2015
Gates Foundation CEO: A Picture Of Hope In Early Ebola Vaccine Trials
Efforts to develop vaccines for Ebola are moving more quickly than usual for this kind of disease, says The CEO of The Bill & Melinda Gates Foundation.
Kerry A. Dolan, Forbes Staff Jan 12, 2015

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New Yorker
http://www.newyorker.com/
Accessed 17 January 2015
Surviving Ebola
16 January 2015
In West Africa , people who catch Ebola and do not die are called “survivors…

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Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 17 January 2015
Study of Ebola Drug ZMapp Set for West Africa
17 January 20215
A clinical trial of the experimental Ebola drug ZMapp may be ready to get under way in infected patients in West Africa in February, the latest effort to combat the current epidemic and any future outbreaks.

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Washington Post
http://www.washingtonpost.com/
Accessed 17 January 2015
Editorial –The Post’s View
The United States should generously support Gavi’s immunization efforts
The Washington Post | 11 January 2015
AN IMPORTANT conference is to be held in Berlin on Jan. 27 to secure financial replenishment for Gavi, the Vaccine Alliance, a multilateral nonprofit that for 15 years has been bringing vaccines to children in the world’s 73 poorest nations. Many attendees will be watching to see what the United States pledges to the effort for the next few years. It ought to be generous…

Ebola/EVD: Additional Coverage [to 17 January 2015]

Ebola/EVD: Additional Coverage

UNMEER [UN Mission for Ebola Emergency Response] @UNMEER #EbolaResponse

Editor’s Note: UNMEER’s website is aggregating and presenting content from various sources including its own External Situation Reports, press releases, statements and other formats.

We present a composite below from the week ending 17 January 2015. We also note that 1) a regular information category in these reports – human rights – has apparently eliminated as it no longer appears in any of the continuing updates, and 2) the content level of these reports continues, in our view, to trend less informative and less coherent. We will review continuing coverage of this material over the next few weeks.

UNMEER External Situation Reports
UNMEER External Situation Reports are issued daily (excepting Saturday) with content organized under these headings:
– Highlights
– Key Political and Economic Developments
– Human Rights
– Response Efforts and Health
– Logistics
– Outreach and Education
– Resource Mobilisation
– Essential Services
– Upcoming Events

The “Week in Review” will present highly-selected elements of interest from these reports. The full daily report is available as a pdf using the link provided by the report date.

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:: 16 Jan 2015 UNMEER External Situation Report
Response Efforts and Health
2. In Sierra Leone, the UNICEF-led Family Tracing and Reunification (FTR) network have identified 15,258 children as being directly affected by the Ebola crisis (7,664 girls and 7,594 boys), with 7,968 children having lost one or both parents to Ebola and 552 unaccompanied or separated from their caregiver. 9,103 Ebola-affected children have been provided with psychosocial support.
8. The OCHA Ebola Virus Outbreak Overview of Needs and Requirements, now totaling USD 1.5 billion, has been funded for USD 1.15 billion, which is around 77% of the total ask.
Essential Services
13. The guidelines for the reopening of schools in February was shared with educational authorities in Sinoe County, Liberia. The schools need to establish a committee to oversee the implementation of the guidelines, register the students and identify people trained in IPC procedures. Medical Team International (MTI) offered to distribute the guidelines to the schools. UNICEF will provide three thermoflashes per school to 220 schools. Among the challenges and issues in instituting the guidelines are: 1) the lack of personnel to implement them in the schools (some schools have one teacher for 100 students); 2) the inaccessibility of some schools due to their remote location; 3) lack of basic equipment like printers and photocopiers to disseminate the guidelines; and 4) lack of clarity on no-touch policy for people caring for children under 3-years-old (it may not be possible to institute the policy in these cases). The general community health volunteers (gCHVs) plan to support the schools in some locations.
14. Preparations are underway for a second mass distribution of anti-malaria treatments in Ebola hotspots in Sierra Leone. An estimated 2.5 million are expected to be reached in the coming

:: 15 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. According to press reports, President Ernest Bai Koroma of Sierra Leone predicted while visiting Port Loko, Tonkolili and Bombali in the northern District that his country would be Ebola-free by May.
2. In Forécariah, Kindia Prefecture, Guinea, following the lynching of two police officers and a driver by the local population on 17 January, tension remains high. Evaluation team for the campaign “Zero Ebola in 60 days” reported that several villages were currently inaccessible due to the heightened tension.

:: 14 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. UNDP is leading an Early Recovery Assessment mission in the three most affected countries. The mission includes representatives from the World Bank, the African Development Bank, the European Union and UN agencies. In Liberia, the mission met with President Ellen Johnson-Sirleaf, as well as with Ministers and Deputy Ministers, the Governance Commission, Land Commission, Civil Services Agency and the leadership of the IMS and UNMEER. The mission is today in Sierra Leone and will then travel to Guinea before compiling a plan for early recovery in the three most affected countries.
2. The Islamic Development Bank (IDB), has announced financing in the amount of USD 35 million to countries affected by Ebola.
Response Efforts and Health
3. Health workers have been paid across Liberia in a coordinated effort led by the Ministry of Health and supported by UNDP and UNMEER. In total, more than USD 1 million in cash was distributed to thousands of workers, with Ministry of Health, Ministry of Finance and UNDP staff travelling to remote areas over the past six days. Logistics assistance was provided by WFP and UNMEER, as well as the County Health Teams. The Ministry is now collecting data from the field and will report on final numbers this week.
6. As of last week, the number of children in Liberia registered as orphaned due to EVD is 4,372. All of the children identified are currently receiving follow-up and psychosocial support. The Child Protection Sub-Cluster estimates that there can be as many as 7,500 Ebola orphans in Liberia. UNICEF is partnering with the government and NGOs to train and engage more social workers to identify and ensure that all the orphans are in an adequately protective environment.

:: 13 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
3. Two new World Bank reports indicate that the socio-economic impacts of Ebola in Liberia and Sierra Leone are far-reaching and persistent. Both countries continue to experience job losses, despite their differing health outlooks. These impacts have not been limited to the areas where infections have been the highest, which points to economy-wide slowdowns. As a result, many households have been forced to take short-term actions to cope, which can have substantial long-term effects on welfare.
Outreach and Education
14. UNICEF, in partnership with the Monrovia and Paynesville city councils, Liberia launched Operation Stop Ebola – a mass media, community outreach and engagement campaign targeting 900,000 people or about 80 percent of the population of Montserrado County. To this end, 170 commissioners, governors and community leaders have been trained.
15. In Sierra Leone, social mobilizers from various agencies mobilized 782 religious leaders and 2,077 community leaders and reached 11,003 households to inform them about improvements in services and to mobilize people to seek early care and treatment. The intensification resulted in an increase in number of calls to the 117 hotline to report sick or suspected cases or to seek information and care. It also led to an increase in ‘walk-ins’ and

:: 12 Jan 2015 UNMEER External Situation Report
Response Efforts and Health
3. WFP has finalised the rehabilitation of a hospital in Kambia, Sierra Leone, to be managed by Partners in Health (PiH). This hospital will be used as a Holding Centre with 40 beds and on 9 January was officially inaugurated by President Ernest Bai Koroma. WFP has the capacity to provide additional necessary equipment and staff to support the construction of additional wings at the hospital; this Centre could be extended to become an Ebola Treatment Unit (ETU) with a capacity to hold up to 100 beds, by erecting an additional 10m x 24m Mobile Storage Unit (MSU).

Vaccines and Global Health: The Week in Review 10 January 2015

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

.Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_10 January 2015

blog edition: comprised of the approx. 35+ entries posted below on this date.

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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Support:  If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary, and follow the relevant steps . Thank you…

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

POLIO [to 10 January 2015]

POLIO [to 10 January 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 7 January 2014
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: The last few years have seen the Global Polio Eradication Initiative (GPEI) evolve and grow in response to the threats posed to the world by the final strongholds of the poliovirus. Despite being more geographically limited than ever before, at the end of 2014 the virus continues to pose challenges that must be faced in 2015 if we are to protect children from this disease forever. Polio eradication efforts in 2015 will have five priorities: refining surveillance to catch any remaining virus, keeping Africa and the Middle East polio-free, providing a surge of support to Pakistan and Afghanistan, preparing for the withdrawal of oral polio vaccine type 2 and continuing to demonstrate and build on the differences that the polio programme makes to strengthen routine immunization programmes. More

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Selected country report content:
Afghanistan
:: Two new wild poliovirus type 1 (WPV1) cases were reported in the past two weeks in Panjwayi district of Kandahar province. The most recent case had onset of paralysis on 4 December. The total number of WPV1 cases for 2014 in Afghanistan is now 28 compared to 14 in 2013. The bulk of these cases are linked to cross-border transmission with neighbouring Pakistan.
:: Subnational Immunization Days (SNIDs) are planned for 11 – 13 and 25 – 27 January in high risk areas of the south and east using bivalent oral polio vaccine (OPV). On 15 – 17 February, SNIDs will take place across the entire south of the country, also using bivalent OPV. The next National Immunization Days (NIDs) are planned for March using a combination of inactivated polio vaccine (IPV) and trivalent OPV.
Nigeria
:: One new type 2 circulating vaccine-derived poliovirus (cVDPV2) case was reported in the last week. This most recent case had onset of paralysis on 16 November in Barde district of Yobe state. The total number of cVDPV2 cases for 2014 in Nigeria is now 29.
Pakistan
:: Six new wild poliovirus type 1 (WPV1) cases were reported in the past 2 weeks. Two are from Balochistan (1 in Killa Abdullah district and the other in newly infected Chaghai district); 2 from Khyber Pakhtunkhwa (KP) province, both in Peshawar; and 2 from the Federally Administered Tribal Areas (FATA) in Khyber Agency. The total number of WPV1 cases in Pakistan in 2014 is now 297, compared to 93 in 2013. The most recent WPV1 cases had onset of paralysis on 15 December in Khyber Agency.
:: Immunization activities are continuing with particular focus on known high-risk areas, in previously inaccessible areas of FATA. At exit and entry points of conflict-affected areas 100 permanent vaccination points are being used to reach internally displaced families as they move in and out of the inaccessible area.
West Africa
:: The Ebola crisis in western Africa continues to have an impact on the implementation or polio eradication activities in Liberia, Guinea and Sierra Leone. Supplementary immunization activities (SIAs) in these countries have been postponed and the quality of acute flaccid paralysis surveillance has markedly decreased this year. National Immunization Days (NIDs) have been rescheduled for Guinea, Liberia and Sierra Leone from the 27 February to 31 March. The programme continues to monitor the situation with concern.
:: Even as polio programme staff across West Africa support efforts to control the Ebola outbreak affecting the region, efforts are being made in those countries not affected by Ebola to vaccinate children against polio to create a buffer zone surrounding the Ebola-affected countries.
:: NIDs are planned using bivalent oral polio vaccine (OPV) in Niger and Benin on 27 February to 2 March, and tentatively in Mali in March with dates to be confirmed. From the 27 to 31 March, NIDs will take place in Benin, Burkina Faso, Cote d’Ivoire, Mali, Niger and Senegal using trivalent OPV.

EBOLA/EVD [to 10 January 2015]

EBOLA/EVD [to 10 January 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Editor’s Note:
Our extensive coverage of Ebola/EVD activity continues – including detailed coverage of UNMEER now available at the end of this digest and other INGO/agency activity reported in the relevant sections below. Please also note that many of the journals we cover continue to publish important EVD content which is threaded throughout this edition.

Important this week was a milestone WHO meeting on EVD vaccine candidates and new clinical trials to begin in the most affected countries shortly as reported below.

We also note that the WHO Situation Report below clarifies that the “100% goals” for 1 January 2015 were not met. We are not aware that these goals (or revised/additional goals) with a new date target have been announced.

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Ban Ki-moon on his priorities for 2015 – General Assembly, Informal meeting of the plenary – 8 Jan 2014
– Video: http://webtv.un.org/watch/ban-ki-moon-on-his-priorities-for-2015-general-assembly-informal-meeting-of-the-plenary/3978253934001
– Text: http://www.un.org/sg/statements/index.asp?nid=8312
Excerpt on Ebola

…The outbreak of Ebola in West Africa has been a human tragedy and a setback for development in the hardest hit countries, and has highlighted the need for global vigilance and solidarity.

I thank the General Assembly for its unprecedentedly rapid action to establish UNMEER, the UN Mission for Ebola Emergency Response. The affected countries are beginning to see some improvements, thanks to their own mobilization and global support. Mali has made progress in controlling the virus, and we hope that Mali will be declared Ebola-free this month.

I have been especially moved by the deployment of health workers from many African countries and other parts of the world. But, Excellencies, we are still short of people and resources. As we strive to fill those gaps, we also need to address the wider impacts and to meet recovery needs.

We must also prepare for any possible new epidemic, wherever it may occur. Strengthening national health systems is a priority. International rapid response capacities must be improved. In that regard, I support the efforts of the World Health Organization led by Dr. Margaret Chan, to begin work on the way forward….

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WHO: Ebola response roadmap – Situation report 7 January 2015
[Excerpt]
Summary
:: Reported case incidence continues to fluctuate in Guinea, with no identifiable downward trend. Ebola virus disease (EVD) continues to spread geographically within the country, with the prefecture of Fria reporting 2 confirmed cases for the first time. Case incidence has declined to low levels in Liberia. There are signs that incidence has levelled off in Sierra Leone, although transmission remains intense in the west of the country.

:: The UN Mission for Ebola Emergency Response (UNMEER) set twin targets of isolating and treating 100% of EVD cases, and conducting 100% of burials safely and with dignity by 1 January, 2015, in Guinea, Liberia, and Sierra Leone.

:: Each of the intense-transmission countries has sufficient capacity to isolate and treat patients, with more than 2 treatment beds per reported confirmed and probable case. However, the uneven geographical distribution of beds and cases, and the under-reporting of cases, means that the UNMEER target of isolating and treating 100% of EVD cases is still not met in some areas. An increasing emphasis will be put on the rapid deployment of smaller treatment facilities to ensure that capacity is matched with demand in each area.

:: Similarly, each country has sufficient capacity to bury all people known to have died from EVD, though the under-reporting of deaths means that the UNMEER target of 100% safe burial was not met.

:: In addition to the two UNMMER targets, there are several other crucial aspects of the response, including rigorous contact tracing, access to laboratory services, and community engagement.

:: Guinea, Liberia and Sierra Leone report that more than 90% of registered contacts are monitored, though the number of contacts traced per EVD case remains lower than expected in many districts. In areas where transmission has been driven down to low levels, rigorous contact tracing will be essential to break chains of transmission.

:: There are currently 23 laboratories providing case-confirmation services in the three intense-transmission countries. Five more laboratories are planned in order to meet demand.

:: Case fatality among hospitalized patients (calculated from all hospitalized patients with a reported definitive outcome) is approximately 60% in the three intense-transmission countries.
:: A total of 820 health-care worker infections have been reported in the intense-transmission countries; there have been 488 deaths.

:: Many elements of the response to the EVD outbreak, from safe burials to contact tracing, rely on actively engaging affected communities to take ownership of the response. UNICEF leads the community engagement arm of the EVD response. At present, 33 of 38 (87%) of districts in Guinea, 100% of districts in Liberia, and 57% (8 of 14) of districts in Sierra Leone have systems in place to monitor community engagement activities.

1. COUNTRIES WITH WIDESPREAD AND INTENSE TRANSMISSION
There have been in excess of 20,000 confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (table 1), with more than 8,000 deaths (deaths are under-reported).

A stratified analysis of cumulative confirmed and probable cases indicates that the number of cases in males and females is about the same (table 2).

Compared with children (people aged 14 years and under), people aged 15 to 44 are three times more likely to be affected (33 reported cases per 100 000 population, compared with 98 per 100,000 population). People aged 45 and over (125 reported cases per 100 000 population) are almost four times more likely to be affected than are children.

There have been 26 reported confirmed and probable cases per 100,000 population in Guinea, 206 cases per 100,000 population in Liberia, and 170 cases per 100,000 population in Sierra Leone…

WHO: Second high-level meeting on Ebola vaccines access and financing – 8 January 2015

WHO: Second high-level meeting on Ebola vaccines access and financing
Date: 8 January 2015
Place: Geneva, Switzerland
About the meeting
On 8 January 2015, WHO will convene the second high-level meeting on Ebola vaccines access and financing. The meeting will review the current status of clinical trials of Ebola vaccines and plans for Phase II and Phase III efficacy trials. ‘

Also on the agenda are discussion of funding mechanisms for potential Ebola vaccine introduction and the process for decision-making on introduction beyond Phase III trials. This meeting is a follow-up to the First high-level meeting on Ebola vaccines access and financing held on 23 October 2014.
Participants of the meeting

The meeting will be chaired by Professor Helen Rees, University of Witwatersrand and Co-Chair of the SAGE Ebola Vaccine Working Group. Participants include representatives from manufacturers and research institutions that are currently developing or testing Ebola candidate vaccines, government officials from the Ebola-affected and neighbouring countries, and nongovernmental organizations and partners.

Meeting documents
Agenda of the meeting
pdf, 266kb
List of participants
pdf, 120kb

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WHO Director-General opens high-level meeting on Ebola vaccines
8 January 2015
Distinguished experts,
Good morning and welcome to this second high-level meeting on Ebola vaccines access and financing. I thank you again for giving us your expertise and your time.

I will be brief. You have given yourselves some very tight deadlines and are moving ahead quickly. In fact, what you are doing is unprecedented: compressing into a matter of months work that normally takes 2 to 4 years, yet with no compromise of international standards of safety and efficacy.

We are here to take stock, plan the next steps, and make sure that all partners are working in tandem. We all want the momentum and sense of urgency to continue. We want to spot potential bottlenecks early and iron out any difficulties that could slow things down. Even the highest ambitions become feasible with determination and good planning.

Previous experts agreed that vaccines will have an impact on the Ebola epidemic in any future scenario, whether worst-case or best-case. I see no indication that this view has changed.

In terms of the dynamics of the outbreaks in Guinea, Liberia, and Sierra Leone, last year did not end with a best-case scenario. Too many health care workers are still getting infected, including nationals and doctors and nurses from foreign medical teams.

The situation in Liberia looks far more promising than it did in October and November, with cases showing a persistent decline and smaller geographical distribution. But transmission in Monrovia continues, with cases scattered throughout the city, making it difficult to identify distinct transmission chains. Many believe that the virus has moved from the cities into extremely remote rural areas, making it difficult to see what is really happening in Liberia.
Sierra Leone has now outstripped Liberia as the worst-affected country. Several hundred cases are being reported each week.

During the third week in December, Guinea reported nearly 160 confirmed cases, the highest weekly case incidence in the year-long history of the outbreak there.

The wide geographical dispersion of cases remains a problem. Whereas only 7 prefectures reported cases in October, that number had grown to 17 by mid-December.

Ladies and gentlemen,
During this meeting, you will take a look at safety and immunogenicity data emerging from Phase 1 clinical trials of two candidate vaccines and review the status of other vaccines.

It is my understanding that no major safety signals have been reported to date. Trials of the Merck vaccine have restarted after a pause at the end of December.

You will look at vaccine pipelines and consider the plans of companies to extend the safety database during Phase 2 evaluation.

Critically important will be your discussion of preparations for Phase 3 efficacy trials in the three countries, using different trial designs that can take our knowledge base some big steps forward.

We will seek clarity on roles and responsibilities and how to coordinate the different actions. We also need some hard thinking about implementation challenges and how to overcome them.

Financing and implementation of vaccination campaigns are covered in session 4.

You will hear from GAVI and others about planned investments and from WHO’s experienced Ebola fighter, Jean-Marie Okwo-Bele.

Okwo will propose some triggers that can guide decisions about when and how to launch vaccination campaigns.

I think all of us have high expectations for the outcome of this meeting.

As a WHO staff member who has spent several months in Guinea recently observed, what people need most is hope.

They have watched families and communities torn apart by this virus for a year and are close to despair.

You can give them some of that hope.
Thank you.

WHO Press Releases
:: No Ebola cases detected in Iraq
6 January 2015 — The Ministry of Health in Iraq, in collaboration with WHO, confirms that there is no suspected case of Ebola virus disease in Iraq as of 5 January 2015.
:: New UNMEER chief arrives in Liberia to assess Ebola response
6 January 2015 — The new Head of UNMEER, Ismail Ould Cheikh Ahmed, arrived in Liberia as part of his first tour of the affected countries.

Johnson & Johnson Announces Start of Phase 1 Clinical Trial of Ebola Vaccine Regimen

Johnson & Johnson Announces Start of Phase 1 Clinical Trial of Ebola Vaccine Regimen
Company Has Produced More Than 400,000 Vaccine Regimens for Use in Large-Scale Clinical Trials by April 2015

NEW BRUNSWICK, N.J. – Jan. 6, 2015 – Johnson & Johnson (NYSE: JNJ) today announced the start of a Phase 1, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January.

Johnson & Johnson also announced today that Janssen, in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of 2 million regimens will be available through the course of 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period. This increased projection is an update to Janssen’s previous goal of producing more than 1 million regimens by the end of 2015, with 250,000 regimens for broad application in clinical trials by May 2015.

“As a leader in the field of global health, we have a responsibility to act swiftly as Ebola continues to cause suffering among patients, families and health care workers in West Africa,” said Alex Gorsky, Chairman and CEO of Johnson & Johnson.

Modelling by the London School of Hygiene and Tropical Medicine to advise the World Health Organization (WHO) indicates that to bring the epidemic under control, current projected demand for a preventive vaccine ranges from a minimum of 100,000 doses to protect frontline workers to a high-end of 12 million doses for large-scale adult vaccination in the three affected countries.

…The Phase 1, first-in-human study will evaluate the safety and tolerability of a prime-boost vaccine regimen, in which patients are first given a dose to prime the immune system, and then a boost intended to enhance the immune response over time. The immune response generated by the regimen will also be evaluated longer term. Different regimens combining the vaccine components or placebo will be studied in 72 healthy adult volunteers. Additional clinical studies are planned to begin in the United States later this month and soon after in Africa. Further details of the study are posted on clinicaltrials.gov.

In October 2014, Johnson & Johnson announced a commitment of up to $200 million to accelerate and significantly expand production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company is seeking to share the financial risk of these vaccine and development clinical trial costs by pursuing governmental and non-governmental funding sources. The vaccine regimen, which was discovered in a collaborative research program with the National Institutes of Health (NIH), uses a prime-boost combination of two components that are based on AdVac® technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic, a biotechnology company based in Denmark.

The Crucell Holland B.V. program received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I, respectively. Preclinical experiments of the prime-boost vaccine regimen conducted by the NIH demonstrated that when both vaccines were administered two months apart, complete protection from death due to Ebola was achieved against the Kikwit Zaire strain, which is similar to the virus that is the cause of the current outbreak in West Africa. The research collaboration for a monovalent vaccine targeting the Zaire strain of the Ebola virus is part of an ongoing development program for a multivalent vaccine against all virus strains that cause disease in humans, including Ebola and Marburg viruses based on the Ad26 and Ad35 vectors.

The Johnson & Johnson Family of Companies continues to closely collaborate with WHO, NIAID and the European Commission, as well as other key stakeholders, governments, public health authorities, and non-governmental organizations on the clinical testing, development, production and distribution of the vaccine…

clinicaltrials.gov :: A Safety and Immunogenicity Study of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

Merck-NewLink Ebola vaccine trial resumes at lower dose -Geneva hospital – Reuters | 5 January 2015

Merck-NewLink Ebola vaccine trial resumes at lower dose -Geneva hospital
Reuters | 5 January 2015
Excerpt
The clinical trial of an Ebola vaccine developed by Merck and NewLink resumed on Monday at a lower dose after a pause to assess complaints of joint pains in some volunteers, the University of Geneva hospital said…
…The Geneva hospital announced on Dec. 11 that its vaccine trial had been suspended as a precautionary measure after four patients complained of joint pains. On Monday, the hospital said 10 of 59 volunteers who received the vaccine had felt pains in their joints “similar to rheumatism” after some two weeks, but these symptoms had disappeared rapidly without any treatment.
Swissmedic, the Swiss regulatory agency, and ethics and safety committees have approved the resumption of the trial at a lower dose, the hospital said in a statement.
“The second part of this clinical trial will now test a dose of 300,000 vaccine particles, which should be better tolerated by volunteers and will hopefully trigger the production of enough antibodies,” it said, noting that the initial phase had 10 million to 50 million vaccine particles.
“Fortunately”, it said, the Merck-NewLink candidate vaccine “seems able to induce the production of antibodies at lower doses than those previously used” in the Geneva trial.
Vaccinations have now resumed for the last 56 volunteers, who will receive either a low dose of the vaccine or a placebo, by groups of 15 each week through January, it said…

UNICEF Watch [to 10 January 2015]

UNICEF Watch [to 10 January 2015]

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:: UNICEF helps restart measles immunizations in Ebola-hit countries
ENEVA/DAKAR/CONAKRY/FREETOWN/MONROVIA, 9 January 2015 – UNICEF is helping governments and communities restart stalled immunizations amid a surge in measles cases in Ebola-affected countries, where health systems are overwhelmed and tens of thousands of children are left vulnerable to deadly diseases.

“Measles is a major killer of children that can easily be stopped through a safe and effective vaccine,” said Manuel Fontaine, UNICEF Regional Director for West and Central Africa. “But immunization rates have dropped significantly, further threatening children’s lives.”

In Guinea, where a measles outbreak was declared in early 2014 – prior to Ebola – the number of confirmed measles cases increased almost fourfold, from 59 between January and December 2013 to 215 for the same period in 2014, according to WHO. In Sierra Leone, the figure tripled from 13 to 39 over the same period.

In Liberia, which had reported no measles in 2013, four cases have been confirmed in Lofa County, one of the areas hardest hit by Ebola.
The increase in cases of measles – a highly contagious disease – is of particular concern as a drop in immunization coverage rates has left children vulnerable at a time when measles transmission traditionally peaks in West Africa, between December and March…

…As vaccinators venture out to provide lifesaving vaccines, which in many cases are long overdue, they also help with the control of the Ebola outbreak. In compliance with infection prevention and control (IPC) procedures and WHO guidelines on immunization in the context of an Ebola outbreak, UNICEF is providing not only vaccines, but also kits that include gloves and infrared thermometers for vaccinators. Vaccinators are being trained on infection prevention and control measures, supervision during immunization activities, and on how to conduct outreach sessions in areas which have not reported an Ebola case for 42 days…

CDC/MMWR Watch [to 10 January 2015]

CDC/MMWR Watch [to 10 January 2015]
http://www.cdc.gov/media/index.html

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:: Enhanced Airport Entry Screening To End for Travelers from Mali to the United States – Press Release – Monday, January 5, 2015

:: MMWR Weekly, January 9, 2015 / Vol. 63 / No. 53
– Notes from the Field: Acute Flaccid Myelitis Among Persons Aged ≤21 Years — United States, August 1–November 13, 2014
– Notes from the Field: Occupationally Acquired HIV Infection Among Health Care Workers — United States, 1985–2013

MSF/Médecins Sans Frontières [to 10 January 2015]

MSF/Médecins Sans Frontières [to 10 January 2015]

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:: Oxford University Begins Trial of Possible Ebola Treatment at MSF Treatment Center in Monrovia
January 07, 2015
A clinical trial of a possible treatment for Ebola began on January 1, 2015, at ELWA 3, the Doctors Without Borders/Médecins Sans Frontières (MSF) Ebola Management Center in Monrovia, Liberia. Led by Oxford University, the trial aims to determine if the antiviral drug brincidofovir is a safe and effective treatment for Ebola. While MSF hopes that brincidofovir might help patients survive infection, it is still not sure whether this will be the case.

WHO & Regionals [to 10 January 2015]

WHO & Regionals [to 10 January 2015]
:: 136th WHO Executive Board session
26 January–3 February 2015

:: WHO grants approval for safe, effective meningitis A vaccine for infants
9 January 2015
WHO has opened the door to routine immunization of infants in Africa by approving for use an innovative and affordable vaccine that has all but rid the meningitis belt of a major cause of deadly epidemics.
Since its introduction in Africa in December 2010, MenAfriVac has had an immediate and dramatic impact in breaking the cycle of meningitis A epidemics, leading the safe, effective technology to be approved by WHO through its prequalification process for use in infants, and paving the way for protecting millions more children at risk of the deadly disease.
Read the news release on meningitis A vaccine

:: Global Alert and Response (GAR): Disease Outbreak News (DONs)
– Ebola virus disease – United Kingdom 30 December 2014
On 29 December 2014, WHO was notified by the National IHR Focal Point for the United Kingdom of a laboratory-confirmed case of Ebola Virus Disease (EVD). This is the first EVD case to be detected on UK soil.
– 5 January 2015 – Middle East respiratory syndrome coronavirus (MERS-CoV) – Jordan
On 25 December 2014, the National IHR Focal Point of Jordan notified WHO of 1 additional case of Middle East respiratory syndrome coronavirus (MERS-CoV) infection.
Contact tracing of household contacts and healthcare contacts is ongoing for this case.
The National IHR Focal Point for the Kingdom of Saudi Arabia also notified WHO of the death of 3 previously reported MERS-CoV cases.*
Globally, the WHO has been notified of 945 laboratory-confirmed cases of infection with MERS-CoV, including at least 348 related deaths.

:: The Weekly Epidemiological Record (WER) for 9 January 2015, vol. 90, 1/2 (pp. 1–8) includes:
– Immunization and Vaccine related Implementation Research Advisory Committee (IVIR-AC): summary of conclusions and recommendations 17–19 September 2014 meeting

WHO Regional Offices
WHO African Region AFRO
Press Releases
:: Sexual and intimate partner violence affects millions in Africa
Brazzaville, 5 January 2015 – In the African Region, one in five girls have been sexually abused during childhood, with estimates from some countries placing that proportion closer to one in three. This startling statistic is highlighted in the newly released Global status report on violence prevention 2014.

WHO Region of the Americas PAHO
:: PANAFTOSA marks three years without foot-and-mouth disease outbreaks in the Americas
Rio de Janeiro, 5 January 2015 (PANAFTOSA) – January 2015 marks the third year in a row in which the Region of the Americas has had no outbreak of foot-and-mouth disease (FMD), a highly contagious animal disease that can have a devastating impact on livestock.
In marking the achievement, the Pan American Foot-and-Mouth Disease Center (PANAFTOSA), a specialized technical center of the Pan American Health Organization (PAHO), noted the importance of the investments and hard work of the two organizations’ member countries.
Foot-and-mouth disease (FMD) is a highly contagious viral disease that primarily affects cloven-hooved livestock and wildlife. Outbreaks can severely disrupt livestock production and trade, causing major economic losses and threatening food security. FMD is not related to hand, foot and mouth disease, a condition seen only in humans, and is not considered a public health problem, as human cases are extremely rare…

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
:: United Kingdom Ebola case: tracing of airline passengers completed 10-01-2015
:: Kyrgyz initiatives help reduce preventable child mortality 08-01-2015

WHO Eastern Mediterranean Region EMRO
No new digest content identified.

WHO Western Pacific Region
No new digest content identified.

BMGF – Gates Foundation Watch [to 10 January 2015]

BMGF – Gates Foundation Watch [to 10 January 2015]
http://www.gatesfoundation.org/Media-Center/Press-Releases

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New Collection by More Than 30 World-Renowned Artists Illustrates the Global Impact of Vaccines
The Art of Saving a Life Project Features the Work of Angélique Kidjo, Chimamanda Ngozi Adichie, GMB Akash, Sophie Blackall, Thomas Ganter, Vik Muniz, Alexia Sinclair and Others, and Debuts at Critical Moment for Global Vaccine Advocacy

SEATTLE (January 7, 2015) — The Bill & Melinda Gates Foundation today introduced The Art of Saving a Life project, a new initiative that brings together more than 30 world-renowned musicians, writers, filmmakers, painters, sculptors and photographers to demonstrate how vaccines continue to positively change the course of history.

The Art of Saving a Life is designed to support the critical work of Gavi, the Vaccine Alliance by spurring conversations about the value of vaccines. On January 27 in Berlin, German Chancellor Angela Merkel will host a high-level event seeking to mobilize funding for Gavi to help reach an additional 300 million children with life-saving vaccines by 2020. The conference will bring together world leaders, nongovernmental organizations, the private sector and other partners who will show their support for Gavi, and will feature select pieces of The Art of Saving a Life artwork.

“From sculptures to paintings, from digital animations to music, artists have been inspired to capture the amazing power of vaccines,” said Gavi CEO Dr. Seth Berkley. “I’m looking forward to seeing a large part of this work in Berlin, where we will be calling on global leaders to stand together and pledge the necessary funds to immunize 300 million children by 2020, which will prevent up to 6 million deaths. This is a remarkable mix of both the art and science of saving a life.”…

IVI Watch [to 10 January 2015]

IVI Watch [to 10 January 2015]
http://www.ivi.org/web/www/home

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SK Chemicals staff’s interview with SBS TV about collaboration with IVI and BMGF
[Undated]
An interview featuring Dr. KIM Hoon, head of SK Chemicals’ life-science lab, was on SBS ? CNBC TV, a Korean cable station dedicated to business and market, including comments about collaboration with IVI and BMGF. Here are some highlights from the interview.

Q. We hear that SK Chemicals is jointly developing a typhoid fever vaccine.
A. Yes. That’s right.

Q. Notably, SK Chemicals received funding from the Bill & Melinda Gates Foundation, right?
A. SK Chemicals is committed to its mission of improving the health of human beings. The joint development of typhoid vaccine with IVI is very significant in our efforts to achieve this mission.
The fact that IVI picked SK as a partner, and that the Gates provided 5.4 billion won fund is testament to that SK’s vaccine development and production capacities has reached the global level.
By developing a more improved vaccine, SK Chemicals will contribute to saving the precious lives of children in developing countries.
Phase 1 clinical trials will start late this year, and after completion of clinical trials, the vaccine will be produced at SK Chemicals’ plant in Andong, and will be supplied through international organizations.

Q: Could support from the Gates Foundation and cooperation with IVI mean that securing financial profitability is a challenge?
A. It is not a matter of profitability. The shared goal of the two organizations is to improve the health of humanity through vaccines. SK Chemicals also shares this goal.

Q: We hear that prequalification (PQ) is key to this endeavor. Would it be possible to achieve?
A. The new vaccine will likely provide long-term protection, and protection in young children under age 2, which conventional typhoid vaccines do not.
To save children’s lives in developing countries, entering the global market is essential. Due support from IVI, and the Food and Drug Safety Ministry of Korea, and to SK Chemicals’ world-class capacity, we expect development will be completed in line with schedule.

To hear the full interview please click here:
http://sbscnbc.sbs.co.kr/read.jsp?pmArticleId=10000712198

Industry Watch [to 10 January 2015]

Industry Watch [to 10 January 2015]

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:: Pfizer Acquires Redvax GmbH
Acquisition Provides Pfizer with a Preclinical CMV Vaccine Candidate
January 05, 2015
NEW YORK–( Pfizer Inc. today announced that it has acquired a controlling interest in Redvax GmbH, a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, based in Zurich-Schlieren. This transaction provides access to a preclinical human cytomegalovirus (CMV) vaccine candidate, as well as intellectual property and a technology platform related to a second, undisclosed vaccine program…

Global Fund [to 10 January 2015]

Global Fund [to 10 January 2015]
http://www.theglobalfund.org/en/mediacenter/

Press releases
Zambia and Global Fund Sign $234 Million in New Grants
09 January 2015
LUSAKA, Zambia – The Government of the Republic of Zambia, the Churches Health Association of Zambia, and the Global Fund today reaffirmed their partnership, signing four new grants worth US$234 million to fight HIV, TB and malaria in Zambia.

The financial resources provided through the Global Fund come from many donors, represented today by the European Union, Sweden, the United Kingdom and the United States. Beyond finances, the grant agreements embody solidarity with the people of Zambia, supporting health initiatives through partnership with UNAIDS, UNICEF, UNDP, UNFPA, WFP and WHO, (RED), ONE and the Bill & Melinda Gates Foundation and others.

The HIV/TB grants expand availability of anti-retroviral medication for people living with both HIV and tuberculosis from 80 percent in 2013 to a target of 90 percent by 2017. Zambia will also intensify TB case detection among key populations, children, prisoners and other groups identified by Zambia’s TB survey, and enhance HIV/TB integration.
The malaria grants aim to sustain universal coverage of treatment and increase household use of mosquito nets from 49 percent in 2012 to 85 percent by 2017. The number of malaria cases and deaths is expected to halve in 2017 compared with 2013. The grants also strengthen community and health systems…

American Journal of Tropical Medicine and Hygiene – January 2015; 92 (1)

American Journal of Tropical Medicine and Hygiene
January 2015; 92 (1)
http://www.ajtmh.org/content/current

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Editorial
Expanding the Toolbox in Pursuit of a Strain Transcendent Malaria Vaccine
Anne E.P. Frosch and Chandy C. John
Am J Trop Med Hyg 2015 92:1-2; Published online November 24, 2014, doi:10.4269/ajtmh.14-0662
[No abstract]

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Environmental Surveillance for Toxigenic Vibrio cholerae in Surface Waters of Haiti
Am J Trop Med Hyg 2015 92:118-125; Published online November 10, 2014, doi:10.4269/ajtmh.13-0601
Amy M. Kahler, Bradd J. Haley, Arlene Chen, Bonnie J. Mull, Cheryl L. Tarr, Maryann Turnsek, Lee S. Katz, Michael S. Humphrys, Gordana Derado, Nicole Freeman, Jacques Boncy, Rita R. Colwell, Anwar Huq, and Vincent R. Hill
Abstract
Epidemic cholera was reported in Haiti in 2010, with no information available on the occurrence or geographic distribution of toxigenic Vibrio cholerae in Haitian waters. In a series of field visits conducted in Haiti between 2011 and 2013, water and plankton samples were collected at 19 sites. Vibrio cholerae was detected using culture, polymerase chain reaction, and direct viable count methods (DFA-DVC). Cholera toxin genes were detected by polymerase chain reaction in broth enrichments of samples collected in all visits except March 2012. Toxigenic V. cholerae was isolated from river water in 2011 and 2013. Whole genome sequencing revealed that these isolates were a match to the outbreak strain. The DFA-DVC tests were positive for V. cholerae O1 in plankton samples collected from multiple sites. Results of this survey show that toxigenic V. cholerae could be recovered from surface waters in Haiti more than 2 years after the onset of the epidemic.

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The Development and Implementation of a Competency-Based Curriculum for Training in Global Health Research
Thanh G. N. Ton, Sophia P. Gladding, Joseph R. Zunt, Chandy John, Vivek R. Nerurkar, Cheryl A. Moyer, Nicole Hobbs, Molly McCoy and Joseph C. Kolars*
Author Affiliations
Departments of Neurology and Global Health, University of Washington, Seattle, Washington; Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota; Department of Medicine (Infectious Disease), University of Washington, Seattle, Washington; Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii; Global Research, Education and Collaboration in Health (REACH) and Departments of Learning Health Sciences and Internal Medicine, University of Michigan, Ann Arbor, Michigan
Abstract
The Fogarty International Center (FIC) Global Health Fellows Program provides trainees with the opportunity to develop research skills through a mentored research experience, increase their content expertise, and better understand trends in global health research, funding organizations, and pathways to generate support. The Northern Pacific Global Health Fellows Research and Training Consortium, which hosts one of the FIC Global Health Programs, sought to enhance research training by developing, implementing, and evaluating a competency-based curriculum that uses a modular, asynchronous, web-based format. The curriculum has 8 core competencies, 36 learning objectives, and 58 assignments. Nineteen trainees completed their 11-month fellowship, engaged in the curriculum, and provided pre- and post-fellowship self-assessments. Self-assessed scores significantly improved for all competencies. Trainees identified the curriculum as one of the strengths of the program. This competency-based curriculum represents a first step toward creating a framework of global health research competencies on which further efforts could be based.

Annals of Internal Medicine – 6 January 2015, Vol. 162. No. 1

Annals of Internal Medicine
6 January 2015, Vol. 162. No. 1
http://annals.org/issue.aspx

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Original Research | 6 January 2015
Effect of Ebola Progression on Transmission and Control in Liberia
FREE
Dan Yamin, PhD*; Shai Gertler*; Martial L. Ndeffo-Mbah, PhD*; Laura A. Skrip, MPH; Mosoka Fallah, PhD; Tolbert G. Nyenswah, MPH; Frederick L. Altice, MD, MA; and Alison P. Galvani, PhD
[+] Article and Author Information
Ann Intern Med. 2015;162(1):11-17. doi:10.7326/M14-2255
* Dr. Yamin, Mr. Gertler, and Dr. Ndeffo-Mbah contributed equally to this work.
Abstract
Background: The Ebola outbreak that is sweeping across West Africa is the largest, most volatile, and deadliest Ebola epidemic ever recorded. Liberia is the most profoundly affected country, with more than 3500 infections and 2000 deaths recorded in the past 3 months.
Objective: To evaluate the contribution of disease progression and case fatality on transmission and to examine the potential for targeted interventions to eliminate the disease.
Design: Stochastic transmission model that integrates epidemiologic and clinical data on incidence and case fatality, daily viral load among survivors and nonsurvivors evaluated on the basis of the 2000–2001 outbreak in Uganda, and primary data on contacts of patients with Ebola in Liberia.
Setting: Montserrado County, Liberia, July to September 2014.
Measurements: Ebola incidence and case-fatality records from 2014 Liberian Ministry of Health and Social Welfare.
Results: The average number of secondary infections generated throughout the entire infectious period of a single infected case, R, was estimated as 1.73 (95% CI, 1.66 to 1.83). There was substantial stratification between survivors (RSurvivors), for whom the estimate was 0.66 (CI, 0.10 to 1.69), and nonsurvivors (RNonsurvivors), for whom the estimate was 2.36 (CI, 1.72 to 2.80). The nonsurvivors had the highest risk for transmitting the virus later in the course of disease progression. Consequently, the isolation of 75% of infected individuals in critical condition within 4 days from symptom onset has a high chance of eliminating the disease.
Limitation: Projections are based on the initial dynamics of the epidemic, which may change as the outbreak and interventions evolve.
Conclusion: These results underscore the importance of isolating the most severely ill patients with Ebola within the first few days of their symptomatic phase.
Primary Funding Source: National Institutes of Health.

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The Potential Ebola–Infected Patient in the Ambulatory Care Setting: Preparing for the Worst Without Compromising Care
FREE
Henry M. Wu, MD; Jessica K. Fairley, MD; James Steinberg, MD; and Phyllis Kozarsky, MD

Caring for Patients With Ebola: A Challenge in Any Care Facility
FREE
Mark G. Kortepeter, MD, MPH; Philip W. Smith, MD; Angela Hewlett, MD; and Theodore J. Cieslak, MD

British Medical Journal – 10 January 2015 (vol 350, issue 7990)

British Medical Journal
10 January 2015 (vol 350, issue 7990)
http://www.bmj.com/content/350/7990

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Editorials
Two or three doses of human papillomavirus vaccine?
Julia Brotherton, medical director
Author affiliations
BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.g7778 (Published 07 January 2015) Cite this as: BMJ 2015;350:g7778
Switching to two doses looks feasible, but only with careful monitoring
Human papillomavirus (HPV) vaccines have the potential to prevent the considerable morbidity and mortality caused by oncogenic HPV types. In the eight years since the vaccines were first licensed, we have seen remarkable reductions in genital warts, HPV infections, and pre-cancerous cervical lesions in vaccinated populations.1 2 3 4 5 6 7 8 However, achieving high coverage with three doses of vaccine is challenging in many populations, and the cost of the vaccine has kept it out of reach for many countries. In a linked paper (doi:10.1136/bmj.g7584), Jit and colleagues explore, through modelling, the potential cost effectiveness of a two dose HPV vaccination schedule.9
Both the bivalent and quadrivalent HPV vaccines were initially registered for use as three dose courses given over six months, using the model of subunit vaccines for which multiple doses are needed to generate a sufficient immune response. However, HPV vaccines are notably immunogenic, producing very high and durable antibody responses, and the virus-like particle structure of the vaccines, with their repetitive antigen display, may be stimulating immunity that is more akin to the response generated by viral infections or live vaccines.10 …

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Research
Comparison of two dose and three dose human papillomavirus vaccine schedules: cost effectiveness analysis based on transmission model
Mark Jit, mathematical modeller and health economist12, Marc Brisson, associate professor of mathematical epidemiology and health economics345, Jean-François Laprise, mathematical modeller3, Yoon Hong Choi, mathematical modeller16
Author affiliations
BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.g7584 (Published 07 January 2015) Cite this as: BMJ 2015;350:g7584
Abstract
Objective
To investigate the incremental cost effectiveness of two dose human papillomavirus vaccination and of additionally giving a third dose.
Design
Cost effectiveness study based on a transmission dynamic model of human papillomavirus vaccination. Two dose schedules for bivalent or quadrivalent human papillomavirus vaccines were assumed to provide 10, 20, or 30 years’ vaccine type protection and cross protection or lifelong vaccine type protection without cross protection. Three dose schedules were assumed to give lifelong vaccine type and cross protection.
Setting
United Kingdom.
Population
Males and females aged 12-74 years.
Interventions
No, two, or three doses of human papillomavirus vaccine given routinely to 12 year old girls, with an initial catch-up campaign to 18 years.
Main outcome measure
Costs (from the healthcare provider’s perspective), health related utilities, and incremental cost effectiveness ratios.
Results
Giving at least two doses of vaccine seems to be highly cost effective across the entire range of scenarios considered at the quadrivalent vaccine list price of £86.50 (€109.23; $136.00) per dose. If two doses give only 10 years’ protection but adding a third dose extends this to lifetime protection, then the third dose also seems to be cost effective at £86.50 per dose (median incremental cost effectiveness ratio £17 000, interquartile range £11 700-£25 800). If two doses protect for more than 20 years, then the third dose will have to be priced substantially lower (median threshold price £31, interquartile range £28-£35) to be cost effective. Results are similar for a bivalent vaccine priced at £80.50 per dose and when the same scenarios are explored by parameterising a Canadian model (HPV-ADVISE) with economic data from the United Kingdom.
Conclusions
Two dose human papillomavirus vaccine schedules are likely to be the most cost effective option provided protection lasts for at least 20 years. As the precise duration of two dose schedules may not be known for decades, cohorts given two doses should be closely monitored

Contemporary Clinical Trials – Volume 41, In Progress (March 2015)

Contemporary Clinical Trials
Volume 41, In Progress (March 2015)

Immunogenicity and safety of measles–mumps–rubella vaccine delivered by disposable-syringe jet injector in healthy Brazilian infants: A randomized non-inferiority study
Original Research Article
Pages 1-8
Reinaldo de Menezes Martins, Birute Curran, Maria de Lourdes Sousa Maia, Maria das Graças Tavares Ribeiro, Luiz Antonio Bastos Camacho, Marcos da Silva Freire, Anna Maya Yoshida Yamamura, Marilda Mendonça Siqueira, Maria Cristina F. Lemos, Elizabeth Maciel de Albuquerque, Vanessa dos Reis von Doellinger, Akira Homma, Laura Saganic, Courtney Jarrahian, Michael Royals, Darin Zehrung
Abstract
This study aimed to determine if immunogenicity to measles–mumps–rubella vaccine delivered to infants via a disposable-syringe jet injector (DSJI) was non-inferior to that administered by needle and syringe (NS). Vaccination safety was evaluated, as were the use, performance, and acceptability of each delivery method. The DSJI was the PharmaJet® 2009 generation-1 device (G1) and the vaccine was measles–mumps–rubella vaccine from Bio-Manguinhos. Five hundred eighty-two healthy Brazilian infants were randomized to receive vaccine via G1 or NS. Seroconversion rates against measles and mumps viruses in the G1 treatment group did not meet non-inferiority criteria when compared with the NS group; however, responses in the G1 group to rubella virus were non-inferior to those of NS vaccinees. Most adverse events were mild or moderate. Crying after injection was more frequent in the NS group, and local skin reactions were more common in the G1 group. Five serious adverse events were judged causally unrelated to treatment and all resolved. Parents/guardians expressed a strong preference for G1 over NS for their children. Vaccinators found the G1 easy to use but noted incomplete vaccine delivery in some cases. Although the G1 has been superseded by an updated device, our results are important for the continued improvement and evaluation of DSJIs, which have the potential to overcome many of the challenges and risks associated with needle-based injections worldwide. Recommendations for future DSJI clinical studies include rigorous training of vaccinators, quantitative measurement of wetness on the skin following injection, and regular monitoring of device and vaccinator performance.

Current Opinion in Infectious Diseases – February 2015 – Volume 28 – Issue 1

Current Opinion in Infectious Diseases
February 2015 – Volume 28 – Issue 1 pp: v-vi,1-116
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx
Ebola virus as a sexually transmitted infection
Rogstad, Karen E.; Tunbridge, Anne
Abstract
Purpose of review
The ongoing Ebola virus epidemic in West Africa is a major global health challenge. The main mode of transmission is through contact with bodily fluids and skin of those infected or who have died. This review was undertaken to consider the evidence for transmission by contact with bodily fluids occurring through sexual activity.
Recent findings
No cases in the previous 20 outbreaks or the current outbreak in West Africa have been shown to be sexually transmitted, although other types of viral haemorrhagic fever have had sexual transmission implicated. Ebola virus is found in sites and fluids associated with sexual activity but this occurs at different stages of the disease. Persistence in the convalescent period occurs in rectum, vagina and semen, with persistence in semen being longest of up to at least 101 days. Recommendations based on this data are that those recovering from Ebola virus disease should abstain from all sexual intercourse, or if this is not possible, use condoms, for 3 months after the onset of symptoms.
Summary
There is theoretical plausibility for sexual transmission of Ebola virus but there has been no evidence of this occurring. Further research is needed to consider if sexual activity contributes to the epidemic in order to inform individuals with regard to avoiding acquisition or transmission by those recovering from Ebola virus disease.

Eurosurveillance – Volume 20, Issue 1, 08 January 2015

Eurosurveillance
Volume 20, Issue 1, 08 January 2015
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Rapid communications
First secondary case of Ebola outside Africa: epidemiological characteristics and contact monitoring, Spain, September to November 2014
by MA Lópaz, C Amela, M Ordobas, MF Domínguez-Berjón, C Álvarez, M Martínez, MJ Sierra, F Simon, JM Jansá, D Plachouras, J Astray, Working group of Ebola outbreak investigation team of Madrid

EbolaTracks: an automated SMS system for monitoring persons potentially exposed to Ebola virus disease
by LE Tracey, AK Regan, PK Armstrong, GK Dowse, PV Effler

Research articles
Assessing the risk of measles resurgence in a highly vaccinated population: Belgium anno 2013
by N Hens, S Abrams, E Santermans, H Theeten, N Goeyvaerts, T Lernout, E Leuridan, K Van Kerckhove, H Goossens, P Van Damme, P Beutels

News
European Union SHIPSAN ACT Joint Action: Preparedness for the response to Ebola virus disease in the maritime transport sector
by VA Mouchtouri, G Nichols

Infectious Diseases of Poverty [Accessed 10 January 2015]

Infectious Diseases of Poverty
[Accessed 10 January 2015]
http://www.idpjournal.com/content

Letter to the Editor
Are surveillance response systems enough to effectively combat and contain the Ebola outbreak?
Viroj Wiwanitkit, Ernest Tambo, Emmanuel Chidiebere Ugwu, Jeane Yonkeu Ngogang and Xiao-Nong Zhou
Infectious Diseases of Poverty 2015, 4:7 doi:10.1186/2049-9957-4-7
Published: 9 January 2015
Abstract (provisional)
The epidemic of the Ebola virus infection in West Africa in 2014 has become a worldwide concern. Due to the nature of the disease, which has an extremely high mortality potential, this outbreak has received much attention from researchers and public health workers. An article entitled “Need of surveillance response systems to combat Ebola outbreaks and other emerging infectious diseases in African countries,” published in the journal Infectious Diseases of Poverty in August 2014, concluded that a good surveillance system to monitor disease transmission dynamics is essential and needs to be implemented to combat the outbreak. Issues regarding the limitation of the passive surveillance system have been raised by Professor Viroj Wiwanitkit, who emphasizes the need for an active disease detection system such as mass screening in this letter to editor. The different function between passive and active surveillance system in combating the disease outbreak has been agreed upon by Ernest Tambo et al. There have also been discussions between Wiwanitkit and Tambo et al. on the following issues: (i) the extreme resource limitations in outbreak areas, (ii) new technology to improve the available systems. Further recommendations echoed in this letter to editor by Wiwanitkit, who outlined the research priorities on the development of appropriate combined disease monitoring systems and good policy to allocate available tools and technology in resource-limited settings for epidemic scenarios. The journal’s editor, Professor Xiao-Nong Zhou, has therefore collated all parts of these discussions between authors in this letter to editor paper, in order to further promote research on a combined active and passive system to combat the present extending Ebola outbreak.

International Health – Volume 7 Issue 1 January 2015

International Health
Volume 7 Issue 1 January 2015
http://inthealth.oxfordjournals.org/content/7/1.toc

EDITORIAL
Chikungunya: here today, where tomorrow?
Stephen Higgs and Dana L. Vanlandingham
Until 2005, chikungunya virus (CHIKV) was a relatively little-studied pathogen restricted to parts of Africa and Asia. Epidemics were sporadic and separated by years of quiescence. In late 2004, the East Central South African genotype of CHIKV moved from Kenya onto the Indian Ocean island of Comoros. The global onslaught of CHIKV had begun. In November of 2005, viral isolates were identified with, what might normally be regarded as an insignificant, single alanine to valine mutation at position 226 of the envelope E1 gene.1 This simple mutation had a remarkable effect; making the virus approximately 100 times more infectious to the Asian tiger mosquito, Aedes albopictus, and it was this species that was transmitting the virus rather than the usual vector, Aedes aegypti.2 Subsequent ‘second-step’ mutations further enhanced the ability of the virus to infect and/or disseminate from the midgut to the salivary glands in Ae. albopictus.3 However, these viruses can still be transmitted by Ae. aegypti. Within a year of the Indian Ocean lineage emerging, over 250 000 people had been infected. An epidemic in Asia began within months and has infected several million people in India and other Asian countries. Chikungunya infections occurred in many countries as a result of people travelling from areas with active transmission. The presence of tiger mosquito vector has been critical to enable localized CHIKV outbreaks in Italy and France. This species continues to invade new territory…

Human rabies deaths in Africa: breaking the cycle of indifference
Betty Dodeta,*, Mathurin C. Tejiokemb, Abdou-Rahman Aguemonc and Hervé Bourhyd
Author Affiliations
aAfroREB coordinator, Dodet Bioscience, 6B rue de Verdun, 69300 Caluire et Cuire, France
bEpidemiology and Public Health Service, Centre Pasteur du Cameroun, Yaoundé, Cameroon
cFaculté des Sciences de la Santé, 01 BP 188, Cotonou, Bénin
dInstitut Pasteur, Unité Dynamique des lyssavirus et adaptation à l’hôte, WHO Collaborating Centre for Reference and Research on Rabies, Paris, France
Received July 22, 2014.
Revision received September 3, 2014.
Accepted September 3, 2014.
Abstract
The current outbreak of Ebola virus disease has mobilized the international community against this deadly disease. However, rabies, another deadly disease, is greatly affecting the African continent, with an estimated 25 000 deaths every year. And yet, the disease can be prevented by a vaccine, if necessary with immunoglobulin, even when administered after exposure to the rabies virus. Rabies victims die because of neglect and ignorance, because they are not aware of these life-saving biologicals, or because they cannot access them or do not have the money to pay for them. Breaking the cycle of indifference of rabies deaths in humans in Africa should be a priority of governments, international organizations and all stakeholders involved.

High coverage of vitamin A supplementation and measles vaccination during an integrated Maternal and Child Health Week in Sierra Leone
Fatmata F. Sesaya,*, Mary H. Hodgesa, Habib I. Kamaraa, Mohamed Turaya, Adam Wolfeb, Thomas T. Sambac, Aminata S. Koromad, Wogba Kamarae, Amadou Fallf, Pamela Mitulaf, Ishata Contehf, Nuhu Makshag and Amara Jambaih
Author Affiliations
aHelen Keller International, PO Box 369, Freetown, Sierra Leone
bColumbia University, Mailman School of Public Health, New York, NY USA
cChild Health and Expanded Program on Immunization, Ministry of Health and Sanitation, Freetown, Sierra Leone
dNutrition Program, Ministry of Health and Sanitation Sierra Leone, Youyi Building Brookfields, Freetown Sierra Leone
eNational HIV/AIDS Secretariat, Ministry of Health and Sanitation, Kingharman Road Freetown, Sierra Leone
fWorld Health Organization, Country Office, Sierra Leone and Inter Country Support Team for West Africa (IST-WA)
gUnited Nations Children’s Fund, Country Office, Sierra Leone
hDirectorate of Disease Prevention and Control, Ministry of Health and Sanitation, Freetown, Sierra Leone
Abstract
Background
In May 2012, the twice-yearly Maternal and Child Health Week (MCHW) integrated vitamin A supplementation (VAS) and supplementary measles vaccination to reach all children 6–59 months in Sierra Leone. Following the MCHW, a post event coverage survey was conducted to validate VAS coverage and assess adverse events following immunization.
Methods
Using the WHO Expanded Program on Immunization sampling methodology, 30 clusters were randomly selected using population proportionate to size sampling. Fourteen caregivers of children 6–59 months were interviewed per cluster for precision of ±5%. Responses were collected via mobile phones using EpiSurveyor.
Results
Overall VAS and measles coverage was 91.9% and 91.6%, respectively, with no significant differences by age group, sex, religion or occupation. Major reasons given for not receiving VAS and measles vaccination were not knowing about the MCHW or being out of the area. Significantly more mild adverse events (fever, pain at injection site) were reported via the post event coverage survey (29.1%) than MCHW (0.01%) (p<0.0001).
Conclusion
The MCHW reached >90% of children in Sierra Leone with equitable coverage. Increased reporting of mild adverse events during the survey may be attributed to delayed onset after measles vaccination and/or direct inquiry from enumerators. Even mild adverse events following immunization requires strengthened reporting during and after vaccination campaigns.

JAMA – January 6, 2015, Vol 313, No. 1

JAMA
January 6, 2015, Vol 313, No. 1
http://jama.jamanetwork.com/issue.aspx

Viewpoint | January 6, 2015
The President’s National Security Agenda – Curtailing Ebola, Safeguarding the Future
FREE
Lawrence O. Gostin, JD1; Henry A. Waxman, JD2; William Foege, MD, MPH3
[+] Author Affiliations
JAMA. 2015;313(1):27-28. doi:10.1001/jama.2014.16572.
[Excerpt]
The Ebola epidemic is projected to affect tens of thousands in Sierra Leone, Liberia, and Guinea, with immense economic and social costs. Even in the United States, where only 1 patient with Ebola virus disease has died, the disease has spurred public fear, tested the readiness of the public health system, and led to measures such as enhanced border screening and state quarantines. The lesson of Ebola is clear: strong, resilient health systems are needed in Africa to curtail the outbreak at its source and in the United States to ameliorate risks and reassure the public.

The United States has led the global response to Ebola, devoting significant financial and human resources, deploying military troops, and sponsoring a groundbreaking United Nations Security Council resolution. Although there is some evidence that the spread of the disease is slowing in Liberia, the response of the United States is still not complete. Health systems in West Africa have been overwhelmed, and the US domestic public health system was not initially prepared, with inadequate training of and protection for health workers and inconsistent exercise of public health powers. This should not be a surprise given the severe budget cuts of recent years, including a 10% reduction in the Centers for Disease Control and Prevention’s 2013 budget1 and the loss of more than 50 000 state public health professionals.2

President Obama is trying to address these challenges. On November 5, 2014, he submitted a $6.2 billion emergency supplemental funding request to Congress to improve domestic and global health capacities in 3 critical areas: a surge of resources for containment and treatment in West Africa; enhanced prevention and detection of, and response to, Ebola entering the United States; and, perhaps most important, buttressing health systems to respond rapidly and flexibly to all hazards in the future.3 Epidemics will occur in the future. It is urgent that Congress support his request…
Original Investigation | January 6, 2015
Quadrivalent HPV Vaccination and Risk of Multiple Sclerosis and Other Demyelinating Diseases of the Central Nervous System
Nikolai Madrid Scheller, MB1; Henrik Svanström, MSc1; Björn Pasternak, MD, PhD1; Lisen Arnheim-Dahlström, PhD2; Karin Sundström, MD, PhD3; Katharina Fink, MD, DrMed4,5; Anders Hviid, DrMedSci1
[+] Author Affiliations
JAMA. 2015;313(1):54-61. doi:10.1001/jama.2014.16946.
Abstract
Importance
Case reports have suggested a link between human papillomavirus (HPV) vaccination and development of multiple sclerosis and other demyelinating diseases.
Objective
To investigate if quadrivalent HPV (qHPV) vaccination is associated with an increased risk of multiple sclerosis and other demyelinating diseases.
Design, Setting, and Participants
Using nationwide registers we identified a cohort of all females aged 10 years to 44 years in Denmark and Sweden, followed up from 2006 to 2013, information on qHPV vaccination, and data on incident diagnoses of multiple sclerosis and other demyelinating diseases. The primary analysis used a cohort design including vaccinated and unvaccinated study participants. A secondary analysis used a self-controlled case-series design including only cases. Both analyses used a 2-year risk period following vaccination.
Exposures
Information on qHPV vaccination was obtained through the national vaccination and prescription registers.
Main Outcomes and Measures
The primary outcomes were multiple sclerosis and a composite end point of other demyelinating diseases. Incidence rate ratios were estimated using Poisson regression, comparing rates of events in the 2-year risk periods following vaccination and in unvaccinated time periods.
Results
The study included 3 983 824 females, among whom 789 082 received a total of 1 927 581 qHPV vaccine doses. During follow-up, 4322 multiple sclerosis cases and 3300 cases of other demyelinating diseases were identified, of which 73 and 90, respectively, occurred within the risk period. In the cohort analysis, there was no increased risk of multiple sclerosis (crude incidence rates, 6.12 events/100 000 person-years [95% CI, 4.86-7.69] and 21.54 events/100 000 person-years [95% CI, 20.90-22.20] for the vaccinated and unvaccinated periods; adjusted rate ratio, 0.90 [95% CI, 0.70-1.15]) or other demyelinating diseases (crude incidence rates, 7.54 events/100 000 person-years [95% CI, 6.13-9.27] and 16.14 events/100 000 person-years [95% CI, 15.58-16.71]; adjusted rate ratio, 1.00 [95% CI, 0.80-1.26]) associated with qHPV vaccination. Similarly, no increased risk was found using the self-controlled case-series design (multiple sclerosis: incidence ratio, 1.05 [95% CI, 0.79-1.38]; other demyelinating diseases: incidence ratio, 1.14 [95% CI, 0.88-1.47]).
Conclusions and Relevance
In this study with nationwide coverage of 2 Scandinavian countries, qHPV vaccination was not associated with the development of multiple sclerosis or other demyelinating diseases. These findings do not support concerns about a causal relationship between qHPV vaccination and demyelinating diseases.

JAMA Pediatrics – January 2015, Vol 169, No. 1

JAMA Pediatrics
January 2015, Vol 169, No. 1
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint | January 2015
Advancing Children’s Rights and Ensuring the Well-being of Children
Jonathan Todres, JD1
[+] Author Affiliations
JAMA Pediatr. 2015;169(1):5-6. doi:10.1001/jamapediatrics.2014.2470.
[Excerpt]
On November 20, 2014, the global community will celebrate the 25th anniversary of the United Nations Convention on the Rights of the Child, the most comprehensive international legal instrument on children’s rights. The Convention is the most widely ratified human rights treaty in history, ratified by 194 countries. Only the United States, Somalia, and South Sudan have not ratified it. The United States signed the Convention in 1995 but, almost 20 years later, the United States has taken no further action (a treaty becomes legally binding only following ratification). Yet, numerous US children continue to experience various harms. Because physicians witness many children’s rights issues, pediatricians are well-positioned to inform policymakers on challenges children confront and the value of ensuring the rights of all children…

Journal of Infectious Diseases – Volume 211 Issue 3 February 1, 2015

Journal of Infectious Diseases
Volume 211 Issue 3 February 1, 2015
http://jid.oxfordjournals.org/content/current

EDITORIAL COMMENTARY
Delayed BCG Vaccination—Time to Take a Shot
Alexander W. Kay1 and Catherine A. Blish2,3
Author Affiliations
1Department of Pediatrics
2Department of Medicine
3Stanford Immunology, Stanford University School of Medicine, California
(See the major article by Toukam Tchakoute et al on pages 338–46.)
[Excerpt]
The BCG vaccine is often derided for the lack of efficacy in preventing Mycobacterium tuberculosis infection and pulmonary disease in adults. However, BCG vaccine remains a highly effective and cost-efficient intervention to prevent tuberculous meningitis and miliary tuberculosis in infants, reducing the incidence of these life-threatening and debilitating infections by approximately 75% [1, 2]. In addition, BCG vaccine coverage rates typically exceed those of other vaccines because it can be administered at birth as a single vaccination [3].

However, this strength of the BCG vaccination strategy has become a liability because of the risks of administering BCG vaccine to human immunodeficiency virus (HIV)–infected infants. The HIV diagnosis is typically not made until the second or third month of life in resource-limited settings, and BCG vaccination in this population results in unacceptably high rates of disseminated BCG disease of 417–992 cases per 100,000 vaccinations, with a mortality of approximately 75% [4–6]. To put this in perspective, this rate of disseminated BCG disease exceeds the rate of disseminated disease due to M. tuberculosis in the same South African population of HIV-infected infants, which is estimated to be 241 cases per 100,000 [7]. In light of this significant risk for the vaccine to cause harm, the World Health Organization (WHO) now identifies known HIV infection in infants, or HIV exposure and symptoms concerning for HIV, as contraindications to BCG vaccination [8, 9]. The rationale for this recommendation is augmented by the unknown clinical efficacy of BCG vaccination in HIV-infected infants and the immunologic data suggesting that BCG given at birth is unlikely to be efficacious in this population [10]….

.

Delaying BCG Vaccination Until 8 Weeks of Age Results in Robust BCG-Specific T-Cell Responses in HIV-Exposed Infants
Christophe Toukam Tchakoute1, Anneke C. Hesseling4, Elvis B. Kidzeru1, Hoyam amieldien1,2,
Jo-Ann S. Passmore2,5, Christine E. Jones3,6, Clive M. Gray1,5, Donald L. Sodora7 and Heather B. Jaspan1,7
Author Affiliations
1Division of Immunology
2Division of Medical Virology
3Institute of Infectious Disease and Molecular Medicine, Department of Clinical Laboratory Sciences, University of Cape Town
4Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town
5National Health Laboratory Services, South Africa
6Paediatric Infectious Diseases Research Group, St George’s, University of London, United Kingdom
7Seattle Biomedical Research Institute, Washington
Presented in part: 6th South African AIDS Conference, Durban, South Africa, June 2013; World Society for Pediatric Infectious Diseases Conference, Cape Town, South Africa, November 2013.
Abstract
Background
BCG vaccination prevents disseminated tuberculosis in children, but it is contraindicated for persons with human immunodeficiency virus (HIV) infection because it can result in severe disease in this population. In tuberculosis-endemic regions, BCG vaccine is administered soon after birth, before in utero and peripartum HIV infection is excluded. We therefore assessed the immunogenicity of BCG vaccine in HIV-exposed infants who received BCG at birth or at 8 weeks of age.
Methods
HIV-exposed, uninfected infants were randomly assigned to receive BCG vaccination at birth (the early vaccination arm) or 8 weeks of age (the delayed vaccination arm). BCG-specific proliferative and intracellular cytokine responses were assessed in 28 infants per arm at 6, 8, and 14 weeks of life.
Results
There was no difference in BCG-specific T-cell proliferation between the study arms 6 weeks after vaccination. However, at 14 weeks of age, the frequency of interferon γ–expressing CD4+ T cells and multifunctional BCG-specific responses in the delayed vaccinated arm were significantly higher than those in the early vaccination arm (P = .021 and P = .011, respectively).
Conclusions
The immunogenicity of BCG vaccination in HIV-exposed, uninfected infants is not compromised when delayed until 8 weeks of age and results in robust BCG-specific T-cell responses at 14 weeks of age. These findings support further evaluation of this modified BCG vaccination strategy for HIV-exposed infants.
Clinical Trials Registration. NCT02062580.

.
Live Attenuated and Inactivated Influenza Vaccines in Children
Natalia A. Ilyushina1,a, Brenda C. Haynes1, Anne G. Hoen2,b, Alexey M. Khalenkov1,b, Molly L. Housman3, Eric P. Brown4, Margaret E. Ackerman4, John J. Treanor5, Catherine J. Luke6, Kanta Subbarao6 and Peter F. Wright1
Author Affiliations
1Department of Pediatrics
2Department of Community and Family Medicine
3Department of Microbiology and Immunology, Geisel School of Medicine at Dartmouth
4Department of Thayer School of Engineering at Dartmouth, Hanover, New Hampshire
5Department of Medicine, University of Rochester Medical Center, New York
6Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
Presented in part: American Society for Virology, 31st Annual Meeting, Madison, Wisconsin 21–25 July 2012; Pediatric Academic Societies, Boston, Massachuetts, 28 April–1 May, 2012.
a Present affiliation: Food and Drug Administration Center for Drug Evaluation and Research, Bethesda, Maryland.
b A. G. H. and A. M. K. contributed equally to this work.
Abstract
Background
Live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) are available for children. Local and systemic immunity induced by LAIV followed a month later by LAIV and IIV followed by LAIV were investigated with virus recovery after LAIV doses as surrogates for protection against influenza on natural exposure.
Methods.
Fifteen children received IIV followed by LAIV, 13 an initial dose of LAIV, and 11 a second dose of LAIV. The studies were done during autumn 2009 and autumn 2010 with the same seasonal vaccine (A/California/07/09 [H1N1], A/Perth/16/09 [H3N2], B/Brisbane/60/08).
Results.
Twenty-eight of 39 possible influenza viral strains were recovered after the initial dose of LAIV. When LAIV followed IIV, 21 of 45 viral strains were identified. When compared to primary LAIV infection, the decreased frequency of shedding with the IIV-LAIV schedule was significant (P = .023). With LAIV-LAIV, the fewest viral strains were recovered (3/33)—numbers significantly lower (P < .001) than shedding after initial LAIV and after IIV-LAIV (P < .001). Serum hemagglutination inhibition antibody responses were more frequent after IIV than LAIV (P = .02). In contrast, more mucosal immunoglobulin A responses were seen with LAIV.
Conclusions.
LAIV priming induces greater inhibition of virus recovery on LAIV challenge than IIV priming. The correlate(s) of protection are the subject of ongoing analysis.
Clinical Trials Registration. NCT01246999.

The Journal of Law, Medicine & Ethics – Winter 2014 Volume 42, Issue 4

The Journal of Law, Medicine & Ethics
Winter 2014 Volume 42, Issue 4 Pages 408–602
http://onlinelibrary.wiley.com/doi/10.1111/jlme.2014.42.issue-4/issuetoc
Special Issue: SYMPOSIUM: The Buying and Selling of Health Care

Global Emergency Legal Responses to the 2014 Ebola Outbreak: Public Health and the Law (pages 595–601)
James G. Hodge Jr., Leila Barraza, Gregory Measer and Asha Agrawal
Article first published online: 6 JAN 2015 | DOI: 10.1111/jlme.12179
[No abstract]

Journal of Medical Ethics – January 2015, Volume 41, Issue 1

Journal of Medical Ethics
January 2015, Volume 41, Issue 1
http://jme.bmj.com/content/current
JME40: Good medical ethics

Paper
The impossibility of informed consent?
Kenneth Boyd
Received 1 September 2014
Revised 26 September 2014
Accepted 23 October 2014
Abstract
The problematic nature of informed consent to medical treatment and research, and its relation to autonomy, trust and clinical practice, has been addressed on many occasions and from a variety of ethical perspectives in the pages of the Journal of Medical Ethics. This paper gives an account of how discussion of these issues has developed and changed, by describing a number of significant contributions to these debates which provide examples of ‘doing good medical ethics’ over the 40 years of the Journal’s publication.

Journal of Public Health Policy – Volume 36, Issue 1 (February 2015)

Journal of Public Health Policy
Volume 36, Issue 1 (February 2015)
http://www.palgrave-journals.com/jphp/journal/v36/n1/index.html

Editorial
Lessons from the public health response to Ebola
Journal of Public Health Policy (2015) 36, 1–3. doi:10.1057/jphp.2014.51; published online 11 December 2014
Anthony Robbins Co-Editor and Ruth Berkelman Member, JPHP Editorial Board

Anything we say today about Ebola is likely to seem dated by the time it is posted online in weeks or appears in print in months. So we look back, to consider missed opportunities, and into the unknown future to avoid worldwide ‘surprise’ again.

How could the public health world have been so ill prepared for this year’s Ebola virus disease outbreaks in Guinea, Sierra Leone, and Liberia? Although these outbreaks have grabbed the whole world’s attention, we can only describe the response as ‘scrambling to catch-up’.

The hemorrhagic fever caused by the Ebola virus was first described in 1976 in what was then Zaire. There have been additional small outbreaks in sub-Saharan Africa. Uganda and other countries controlled outbreaks, but not without resources and an organized response.

It looks like not everyone was asleep. Lab researchers did what they are good at, and the molecular biology of the Ebola virus is rather well described and advanced in understanding.1 Promising candidate vaccines and antiviral therapies have been developed but they have not progressed to licensure.2, 3 Was testing and licensure left largely to an industry that saw no profit selling an Ebola vaccine to the world’s poorest countries?

Research in the field has been less robust than in the laboratory. Months into the epidemic, there still seemed to be confusion about how the virus was spread. The question of whether some people are more likely to spread the disease than others, so-called ‘super-spreaders’, has lingered. More applied research is surely needed. We learned recently that management of waste disposal – from bodily fluids to personal protective equipment and mattresses – remains inadequately studied. Does everything need to be buried or burned? What works efficiently?

Perhaps it is unfair to expect the world’s major research institutes – the Institut Pasteur, the Karolinska, or the US National Institutes of Health – to put more researchers in the field. But, is there an explanation for the World Health Organization’s (WHO) failure to organize assistance for countries with inadequate resources; to help them prepare for Ebola and other infectious disorders? In the case of Ebola, WHO knew that with preparation and resources, the disease had, in the past, been successfully contained. New global interest in noncommunicable diseases4 must not absolve public health officials for their failure to prepare for infectious disease outbreaks.

Médecins Sans Frontières (MSF) has sent doctors and nurses into the field to help where resources are scarce. They also conduct field research. MSF’s applied research, organized by Epicentre MSF in Paris. Epicentre studies field operations of MSF to learn what works and what does not. They learn what knowledge, strategies, and resources are needed, and how to provide care and protection. MSF developed guidance for the use of personal protective equipment.

In June 2014 MSF was outspoken, calling for a robust response and stating that the outbreak was ‘out of control’ and that they had reached their limit in being able to care for patients with Ebola virus disease in 60 locations across Liberia, Guinea, and Sierra Leone. Was anyone listening? It took 6 weeks until WHO deemed Ebola a ‘Public Health Emergency of International Concern’ and called for a coordinated international response. Countries facing occasional imported cases were in a panic about how to respond at home, while thousands of people in West Africa became infected with Ebola.

Our list of ‘pending’ infectious challenges is far from exhaustive, but it confirms that there are many threats out there. Influenza has received some attention. The coronaviruses – Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome – and the paramyxoviruses – Nipah virus – remain serious threats to health globally.5, 6 Current efforts to control multi-drug resistant tuberculosis are dangerously ‘out of step’ with this grave peril.7, 8 Mosquito control needs to be reinforced so that Chikungunya and Dengue can be prevented. We must look ahead at the full range of threats.

Can we learn from Ebola? We must make sure that lab research, plus applied research and field studies, and the resources for care and prevention will be developed now so that we will not be ‘surprised’ in the future as we seem to have been with Ebola.
[References]

Editorial
Commentary: Ebola: The haves and the have-nots
Adolfo Martínez Palomoa
aCenter for Advanced Studies, Molecular Pathogenesis, Avenida IPN 2508, Mexico City (D.F.) Journal of Public Health Policy (2015) 36, 4–6. doi:10.1057/jphp.2014.50; published online 27 November 2014
Abstract
The Ebola epidemic exemplifies the importance of social determinants of health: poverty and illiteracy, among others.

Viewpoint: The role of sanitation in malnutrition – A science and policy controversy in India
Madhumita Dobea
aDepartment of Health Promotion & Education, All India Institute of Hygiene & Public Health, 110, Chittaranjan Avenue, West Bengal, Kolkata, 700073, India.
Abstract
Over the past decade, India’s economic growth has been remarkable – yet almost half of India’s children under 5 remain stunted. The National Food Security Bill is the country’s response to this critical situation. Studies reveal that Indian children are chronically undernourished, not only because of lack of food but also because of recurring gastrointestinal infections. The stunting problem revolves more around lack of sanitation than food insecurity. Despite acknowledging that malnutrition is ‘complex and multidimensional’, government action has consisted largely of nutritional interventions and subsidized food. Although improvements in sanitation would be the most effective way to reduce excessively high levels of chronic undernutrition and stunting, a review of policy formulation and implementation reveals deficits and disconnects with available scientific evidence. It is time to change these mistaken assumptions and focus on improving access and use of safe sanitation facilities to achieve India’s nutritional goals.

The Lancet – Jan 10, 2015 Volume 385 Number 9963

The Lancet
Jan 10, 2015 Volume 385 Number 9963 p89-200 e4
http://www.thelancet.com/journals/lancet/issue/current

Comment
Beyond Ebola: a new agenda for resilient health systems
Marie Paule Kieny, Delanyo Dovlo
DOI: http://dx.doi.org/10.1016/S0140-6736(14)62479-X
Summary
A resilient health system is one able to absorb the shock of an emergency like Ebola and at the same time continue to provide regular health services, leaving other sectors of the country fully functioning. In Guinea, Liberia, and Sierra Leone, the 2014 Ebola outbreak has claimed many lives and laid waste to economies, food provision, and development. The World Bank’s forecast1 of tens of billions of dollars lost for the three affected countries and the broader west Africa region points to the interdependence between health and countries’ wider socioeconomic landscape.

Comment
Offline: Solving WHO’s “persisting weaknesses” (part 1)
Richard Horton
DOI: http://dx.doi.org/10.1016/S0140-6736(14)62485-5
When the 34 members of WHO’s Executive Board gather in Geneva on Jan 25—first, for a special session on the response to the Ebola outbreak and, second, for its 136th meeting—countries will have an unprecedented opportunity to reflect on the future of the world’s only global health agency. Why unprecedented? Because, in WHO’s own words (from documents submitted to the Board and available on WHO’s website), Ebola has put “enormous strain” on the agency’s managerial structures and systems. The outbreak has had a “significant impact” on WHO’s non-Ebola work, with the result that “time-bound projects will be affected”.

Articles
Global, regional, and national age–sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013
GBD 2013 Mortality and Causes of Death Collaborators
Collaborators listed at the end of the Article
Published Online: 17 December 2014
DOI: http://dx.doi.org/10.1016/S0140-6736(14)61682-2
Summary
Background
Up-to-date evidence on levels and trends for age-sex-specific all-cause and cause-specific mortality is essential for the formation of global, regional, and national health policies. In the Global Burden of Disease Study 2013 (GBD 2013) we estimated yearly deaths for 188 countries between 1990, and 2013. We used the results to assess whether there is epidemiological convergence across countries.
Methods
We estimated age-sex-specific all-cause mortality using the GBD 2010 methods with some refinements to improve accuracy applied to an updated database of vital registration, survey, and census data. We generally estimated cause of death as in the GBD 2010. Key improvements included the addition of more recent vital registration data for 72 countries, an updated verbal autopsy literature review, two new and detailed data systems for China, and more detail for Mexico, UK, Turkey, and Russia. We improved statistical models for garbage code redistribution. We used six different modelling strategies across the 240 causes; cause of death ensemble modelling (CODEm) was the dominant strategy for causes with sufficient information. Trends for Alzheimer’s disease and other dementias were informed by meta-regression of prevalence studies. For pathogen-specific causes of diarrhoea and lower respiratory infections we used a counterfactual approach. We computed two measures of convergence (inequality) across countries: the average relative difference across all pairs of countries (Gini coefficient) and the average absolute difference across countries. To summarise broad findings, we used multiple decrement life-tables to decompose probabilities of death from birth to exact age 15 years, from exact age 15 years to exact age 50 years, and from exact age 50 years to exact age 75 years, and life expectancy at birth into major causes. For all quantities reported, we computed 95% uncertainty intervals (UIs). We constrained cause-specific fractions within each age-sex-country-year group to sum to all-cause mortality based on draws from the uncertainty distributions.
Findings
Global life expectancy for both sexes increased from 65•3 years (UI 65•0–65•6) in 1990, to 71•5 years (UI 71•0–71•9) in 2013, while the number of deaths increased from 47•5 million (UI 46•8–48•2) to 54•9 million (UI 53•6–56•3) over the same interval. Global progress masked variation by age and sex: for children, average absolute differences between countries decreased but relative differences increased. For women aged 25–39 years and older than 75 years and for men aged 20–49 years and 65 years and older, both absolute and relative differences increased. Decomposition of global and regional life expectancy showed the prominent role of reductions in age-standardised death rates for cardiovascular diseases and cancers in high-income regions, and reductions in child deaths from diarrhoea, lower respiratory infections, and neonatal causes in low-income regions. HIV/AIDS reduced life expectancy in southern sub-Saharan Africa. For most communicable causes of death both numbers of deaths and age-standardised death rates fell whereas for most non-communicable causes, demographic shifts have increased numbers of deaths but decreased age-standardised death rates. Global deaths from injury increased by 10•7%, from 4•3 million deaths in 1990 to 4•8 million in 2013; but age-standardised rates declined over the same period by 21%. For some causes of more than 100 000 deaths per year in 2013, age-standardised death rates increased between 1990 and 2013, including HIV/AIDS, pancreatic cancer, atrial fibrillation and flutter, drug use disorders, diabetes, chronic kidney disease, and sickle-cell anaemias. Diarrhoeal diseases, lower respiratory infections, neonatal causes, and malaria are still in the top five causes of death in children younger than 5 years. The most important pathogens are rotavirus for diarrhoea and pneumococcus for lower respiratory infections. Country-specific probabilities of death over three phases of life were substantially varied between and within regions.
Interpretation
For most countries, the general pattern of reductions in age-sex specific mortality has been associated with a progressive shift towards a larger share of the remaining deaths caused by non-communicable disease and injuries. Assessing epidemiological convergence across countries depends on whether an absolute or relative measure of inequality is used. Nevertheless, age-standardised death rates for seven substantial causes are increasing, suggesting the potential for reversals in some countries. Important gaps exist in the empirical data for cause of death estimates for some countries; for example, no national data for India are available for the past decade.
Funding
Bill & Melinda Gates Foundation.