Local, national, and regional viral haemorrhagic fever pandemic potential in Africa: a multistage analysis

The Lancet
Dec 16, 2017 Volume 390 Number 10113 p2605-2738  e51-e59
http://www.thelancet.com/journals/lancet/issue/current

Local, national, and regional viral haemorrhagic fever pandemic potential in Africa: a multistage analysis
David M Pigott, Aniruddha Deshpande, Ian Letourneau, Chloe Morozoff, Robert C Reiner Jr, Moritz U G Kraemer, Shannon E Brent, Isaac I Bogoch, Kamran Khan, Molly H Biehl, Roy Burstein, Lucas Earl, Nancy Fullman, Jane P Messina, Adrian Q N Mylne, Catherine L Moyes, Freya M Shearer, Samir Bhatt, Oliver J Brady, Peter W Gething, Daniel J Weiss, Andrew J Tatem, Luke Caley, Tom De Groeve, Luca Vernaccini, Nick Golding, Peter Horby, Jens H Kuhn, Sandra J Laney, Edmond Ng, Peter Piot, Osman Sankoh, Christopher J L Murray, Simon I Hay
2662
Open Access
Summary
Background
Predicting when and where pathogens will emerge is difficult, yet, as shown by the recent Ebola and Zika epidemics, effective and timely responses are key. It is therefore crucial to transition from reactive to proactive responses for these pathogens. To better identify priorities for outbreak mitigation and prevention, we developed a cohesive framework combining disparate methods and data sources, and assessed subnational pandemic potential for four viral haemorrhagic fevers in Africa, Crimean–Congo haemorrhagic fever, Ebola virus disease, Lassa fever, and Marburg virus disease.
Methods
In this multistage analysis, we quantified three stages underlying the potential of widespread viral haemorrhagic fever epidemics. Environmental suitability maps were used to define stage 1, index-case potential, which assesses populations at risk of infection due to spillover from zoonotic hosts or vectors, identifying where index cases could present. Stage 2, outbreak potential, iterates upon an existing framework, the Index for Risk Management, to measure potential for secondary spread in people within specific communities. For stage 3, epidemic potential, we combined local and international scale connectivity assessments with stage 2 to evaluate possible spread of local outbreaks nationally, regionally, and internationally.
Findings
We found epidemic potential to vary within Africa, with regions where viral haemorrhagic fever outbreaks have previously occurred (eg, western Africa) and areas currently considered non-endemic (eg, Cameroon and Ethiopia) both ranking highly. Tracking transitions between stages showed how an index case can escalate into a widespread epidemic in the absence of intervention (eg, Nigeria and Guinea). Our analysis showed Chad, Somalia, and South Sudan to be highly susceptible to any outbreak at subnational levels.
Interpretation
Our analysis provides a unified assessment of potential epidemic trajectories, with the aim of allowing national and international agencies to pre-emptively evaluate needs and target resources. Within each country, our framework identifies at-risk subnational locations in which to improve surveillance, diagnostic capabilities, and health systems in parallel with the design of policies for optimal responses at each stage. In conjunction with pandemic preparedness activities, assessments such as ours can identify regions where needs and provisions do not align, and thus should be targeted for future strengthening and support.
Funding
Paul G Allen Family Foundation, Bill & Melinda Gates Foundation, Wellcome Trust, UK Department for International Development

Deploy vaccines to fight superbugs

Nature 
Volume 552 Number 7684 pp147-278  14 December 2017
http://www.nature.com/nature/current_issue.html

Comment
Deploy vaccines to fight superbugs
Immunizations combined with antibiotics could be our best shot at combating drug-resistant microbes, argue Rino Rappuoli, David E. Bloom and Steve Black.
[Initial text]
Bacteria, viruses, parasites and fungi that are resistant to drugs cause 700,000 deaths each year. By 2050, such ‘superbugs’, inured to treatments, could cause up to 10 million deaths annually and cost the global economy US$100 trillion12. If this happens, antimicrobial resistance (AMR) will be a bigger killer than cancer is now.
Antimicrobials alone won’t be able to mitigate the threat. The supply of naturally occurring antibiotics seems thin. And efforts to engineer new ones have floundered.
We think that vaccines could be a key way to stem the crisis. To launch a global strategic effort to prioritize their development, scientists, policymakers and key stakeholders need to see antibiotics and vaccines as complementary tools. Here we focus on antibiotic-resistant bacteria, for which the need for solutions is most urgent…

A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults

New England Journal of Medicine
December 14, 2017  Vol. 377 No. 24
http://www.nejm.org/toc/nejm/medical-journal

Original Article
A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults
Lars Ostergaard, M.D., Ph.D., Timo Vesikari, M.D., Ph.D., Judith Absalon, M.D., M.P.H., Johannes Beeslaar, M.D., Brian J. Ward, M.D., C.M., Shelly Senders, M.D., Joseph J. Eiden, M.D., Ph.D., Kathrin U. Jansen, Ph.D., Annaliesa S. Anderson, Ph.D., Laura J. York, Ph.D., Thomas R. Jones, Ph.D., Shannon L. Harris, Ph.D., Robert O’Neill, Ph.D., David Radley, M.S., Roger Maansson, M.S., Jean-Louis Prégaldien, M.S., John Ginis, B.S., Nina B. Staerke, M.D., and John L. Perez, M.D., for the B1971009 and B1971016 Trial Investigators*
N Engl J Med 2017; 377:2349-2362 December 14, 2017
DOI: 10.1056/NEJMoa1614474
Background
MenB-FHbp is a licensed meningococcal B vaccine targeting factor H–binding protein. Two phase 3 studies assessed the safety of the vaccine and its immunogenicity against diverse strains of group B meningococcus.

Critical dynamics in population vaccinating behavior

PNAS – Proceedings of the National Academy of Sciences of the United States
of America

http://www.pnas.org/content/early/
[Accessed 16 December 2017]

Biological Sciences – Ecology:
Critical dynamics in population vaccinating behavior
Demetri Pananos, Thomas M. Bury, Clara Wang, Justin Schonfeld, Sharada P. Mohanty, Brendan Nyhan, Marcel Salathé, and Chris T. Bauch
PNAS 2017 ; published ahead of print December 11, 2017, doi:10.1073/pnas.1704093114
Significance
Complex adaptive systems exhibit characteristic dynamics near tipping points such as critical slowing down (declining resilience to perturbations). We studied Twitter and Google search data about measles from California and the United States before and after the 2014–2015 Disneyland, California measles outbreak. We find critical slowing down starting a few years before the outbreak. However, population response to the outbreak causes resilience to increase afterward. A mathematical model of measles transmission and population vaccine sentiment predicts the same patterns. Crucially, critical slowing down begins long before a system actually reaches a tipping point. Thus, it may be possible to develop analytical tools to detect populations at heightened risk of a future episode of widespread vaccine refusal.
Abstract
Vaccine refusal can lead to renewed outbreaks of previously eliminated diseases and even delay global eradication. Vaccinating decisions exemplify a complex, coupled system where vaccinating behavior and disease dynamics influence one another. Such systems often exhibit critical phenomena—special dynamics close to a tipping point leading to a new dynamical regime. For instance, critical slowing down (declining rate of recovery from small perturbations) may emerge as a tipping point is approached. Here, we collected and geocoded tweets about measles–mumps–rubella vaccine and classified their sentiment using machine-learning algorithms. We also extracted data on measles-related Google searches. We find critical slowing down in the data at the level of California and the United States in the years before and after the 2014–2015 Disneyland, California measles outbreak. Critical slowing down starts growing appreciably several years before the Disneyland outbreak as vaccine uptake declines and the population approaches the tipping point. However, due to the adaptive nature of coupled behavior–disease systems, the population responds to the outbreak by moving away from the tipping point, causing “critical speeding up” whereby resilience to perturbations increases. A mathematical model of measles transmission and vaccine sentiment predicts the same qualitative patterns in the neighborhood of a tipping point to greatly reduced vaccine uptake and large epidemics. These results support the hypothesis that population vaccinating behavior near the disease elimination threshold is a critical phenomenon. Developing new analytical tools to detect these patterns in digital social data might help us identify populations at heightened risk of widespread vaccine refusal.

Ethical review and qualitative research competence: Guidance for reviewers and applicants

Research Ethics
Volume 13, Issue 3-4, July-October 2017
http://journals.sagepub.com/toc/reab/current

Articles
Ethical review and qualitative research competence: Guidance for reviewers and applicants
Julie Mooney-Somers, Anna Olsen
First Published November 30, 2016; pp. 128–138
Preview
It is difficult to consider, describe or address the ethical issues particular to qualitative research without experience and understanding of the technicalities of qualitative methodologies. The Australian National Statement on the Ethical Conduct of Research Involving Humans charges researchers with a responsibility to demonstrate that they have the appropriate experience, qualifications and competence for their proposed research. Ethical review committees have the responsibility to judge claimed research competence. This article provides practical guidance to researchers and review committees on using formal qualifications and training, explicit claims of competence, and markers of in/competence to assess qualitative research competence.

Research with pregnant women: a call to action

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 16 December 2017]

Research with pregnant women: a call to action
Despite a global need for the use of medication during pregnancy, the medical research community lacks robust evidence for safety and efficacy of treatments and preventives often taken by pregnant women.
Authors: Margaret Olivia Little and Marisha N. Wickremsinhe
Citation: Reproductive Health 2017 14(Suppl 3):156
Published on: 14 December 2017

Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 16 December 2017]

Research
Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials
Authors: Melba F. Gomes, Vânia de la Fuente-Núñez, Abha Saxena and Annette C. Kuesel
Citation: Reproductive Health 2017 14(Suppl 3):172
Published on: 14 December 2017
Abstract
Background
For 30 years, women have sought equal opportunity to be included in trials so that drugs are equitably studied in women as well as men; regulatory guidelines have changed accordingly. Pregnant women, however, continue to be excluded from trials for non-obstetric conditions, though they have been included for trials of life-threatening diseases because prospects for maternal survival outweighed potential fetal risks. Ebola virus disease is a life-threatening infection without approved treatments or vaccines. Previous Ebola virus (EBOV) outbreak data showed 89–93% maternal and 100% fetal/neonatal mortality. Early in the 2013–2016 EBOV epidemic, an expert panel pointed to these high mortality rates and the need to prioritize and preferentially allocate unregistered interventions in favor of pregnant women (and children). Despite these recommendations and multiple ethics committee requests for their inclusion on grounds of justice, equity, and medical need, pregnant women were excluded from all drug and vaccine trials in the affected countries, either without justification or on grounds of potential fetal harm. An opportunity to offer pregnant women the same access to potentially life-saving interventions as others, and to obtain data to inform their future use, was lost. Once again, pregnant women were denied autonomy and their right to decide.
Conclusion
We recommend that, without clear justification for exclusion, pregnant women are included in clinical trials for EBOV and other life-threatening conditions, with lay language on risks and benefits in information documents, so that pregnant women can make their own decision to participate. Their automatic exclusion from trials for other conditions should be questioned.

Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 16 December 2017]

Research
Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola
Authors: Séverine Caluwaerts
Citation: Reproductive Health 2017 14(Suppl 3):157
Published on: 14 December 2017
Abstract
During the 2014–2016 Ebola epidemic, Médecins Sans Frontières (MSF) treated Ebola-positive pregnant women in its Ebola Treatment Centers (ETCs). For pregnant women with confirmed Ebola virus disease, inclusion in clinical vaccine/drug/therapeutic trials was complicated. Despite their extremely high Ebola-related mortality in previous epidemics (89–93%) and a neonatal mortality of 100%, theoretical concerns about safety of vaccines and therapeutics in pregnancy were invoked, limiting pregnant women’s access to an experimental live attenuated vaccine and brincidofovir, an experimental antiviral. Favipiravir, another experimental antiviral, was made available to pregnant women only after extensive negotiations and under a ‘Monitored Emergency Use of Unregistered and Experimental Interventions’ (MEURI) protocol. This paper describes the case of a pregnant woman who presented to the ETCs near the end of the Ebola epidemic in Guinea. The pregnant patient was admitted with confirmed Ebola disease. She was previously denied access to potentially protective vaccination due to pregnancy, and access to experimental ZMapp was only possible through a randomized clinical trial (presenting a 50% chance of not receiving ZMapp). She received favipiravir, but died of Ebola-related complications. The infant, born in the ETC, tested positive for Ebola at birth. The infant received ZMapp (under MEURI access outside of the clinical trial), an experimental drug GS5734, and a buffy coat of an Ebola survivor, and survived. Though the infant did have access to experimental therapeutics within 24 h of birth, access to other experimental compounds for her mother was denied, raising serious ethical concerns.

Ethical considerations in developing an evidence base for pre-exposure prophylaxis in pregnant women

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 16 December 2017]

Research
Ethical considerations in developing an evidence base for pre-exposure prophylaxis in pregnant women
Though many women in need of access to HIV preventive regimes are pregnant, there is a dearth of data to guide these care decisions. While oral pre-exposure prophylaxis (PrEP) has been shown to prevent HIV inf…
Authors: Kristen A. Sullivan and Anne D. Lyerly
Citation: Reproductive Health 2017 14(Suppl 3):171
Published on: 14 December 2017

Ethical challenges posed by clinical trials in preterm labor: a case study

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 16 December 2017]

Research
Ethical challenges posed by clinical trials in preterm labor: a case study
This paper explores the ethical implications of a randomized double-blind clinical trial aimed to determine effectiveness and safety of an oxytocin receptor antagonist versus a betamimetic in the treatment of …
Authors: Sofía P. Salas
Citation: Reproductive Health 2017 14(Suppl 3):168
Published on: 14 December 2017

Enrolling pregnant women in research: ethical challenges encountered in Lao PDR (Laos)

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 16 December 2017]

Research
Enrolling pregnant women in research: ethical challenges encountered in Lao PDR (Laos)
Laos has the highest maternal mortality ratio in mainland Southeast Asia but there has been little research conducted with pregnant women. We aim to discuss ethical challenges in enrolling pregnant women in re…
Authors: Vilada Chansamouth, Rose McGready, Danoy Chommanam, Soukanya Homsombath, Mayfong Mayxay and Paul N. Newton
Citation: Reproductive Health 2017 14(Suppl 3):167
Published on: 14 December 2017

The global forum on bioethics in research meeting, “ethics of research in pregnancy”: emerging consensus themes and outputs

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 16 December 2017]

Commentary
The global forum on bioethics in research meeting, “ethics of research in pregnancy”: emerging consensus themes and outputs
Research during pregnancy is affected by multiple ethical challenges which have not received sufficient international attention and consideration from the bioethics, clinical, and policymaking communities work…
Authors: Adrienne Hunt, Natalie Banner and Katherine Littler
Citation: Reproductive Health 2017 14(Suppl 3):158
Published on: 14 December 2017

Durability and correlates of vaccine protection against Zika virus in rhesus monkeys

Science Translational Medicine
13 December 2017    Vol 9, Issue 420
http://stm.sciencemag.org/

Research Articles
Durability and correlates of vaccine protection against Zika virus in rhesus monkeys
By Peter Abbink, Rafael A. Larocca, Kittipos Visitsunthorn, Michael Boyd, Rafael A. De La Barrera, Gregory D. Gromowski, Marinela Kirilova, Rebecca Peterson, Zhenfeng Li, Ovini Nanayakkara, Ramya Nityanandam, Noe B. Mercado, Erica N. Borducchi, Abishek Chandrashekar, David Jetton, Shanell Mojta, Priya Gandhi, Jake LeSuer, Shreeya Khatiwada, Mark G. Lewis, Kayvon Modjarrad, Richard G. Jarman, Kenneth H. Eckels, Stephen J. Thomas, Nelson L. Michael, Dan H. Barouch
Science Translational Medicine13 Dec 2017 Full Access
Not all vaccines afford robust protection against ZIKV challenge in rhesus monkeys at 1 year after vaccination
Patience pays off
As an individual may not encounter the pathogen for years after they have been vaccinated, efficacious vaccines typically require induction of long-lasting immunity. Abbink and colleagues vaccinated nonhuman primates with one of several candidate Zika virus vaccines and then waited an entire year before conducting a viral challenge. These vaccines had all shown promising results in previous experiments with a more immediate challenge, but here, one vaccine faltered, likely due to waning antibodies. The researchers performed more experiments to suggest that circulating antibodies are mediating protection for these vaccines. These results are useful for Zika virus vaccine development and instructive for vaccine development in general.
Abstract
An effective Zika virus (ZIKV) vaccine will require long-term durable protection. Several ZIKV vaccine candidates have demonstrated protective efficacy in nonhuman primates, but these studies have typically involved ZIKV challenge shortly after vaccination at peak immunity. We show that a single immunization with an adenovirus vector–based vaccine, as well as two immunizations with a purified inactivated virus vaccine, afforded robust protection against ZIKV challenge in rhesus monkeys at 1 year after vaccination. In contrast, two immunizations with an optimized DNA vaccine, which provided complete protection at peak immunity, resulted in reduced protective efficacy at 1 year that was associated with declining neutralizing antibody titers to subprotective levels. These data define a microneutralization log titer of 2.0 to 2.1 as the threshold required for durable protection against ZIKV challenge in this model. Moreover, our findings demonstrate that protection against ZIKV challenge in rhesus monkeys is possible for at least 1 year with a single-shot vaccine.
 
 

Attitudes about adult vaccines and reminder/recall in a safety net population

Vaccine
Volume 35, Issue 52  Pages 7213–7346 (19 December 2017)
http://www.sciencedirect.com/journal/vaccine/vol/35/issue/52

Attitudes about adult vaccines and reminder/recall in a safety net population
Original research article
Pages 7292–7296
Karen Albright, Laura P. Hurley, Steven Lockhart, Dennis Gurfinkel, … Allison Kempe
Abstract
Little is known about adult patients’ attitudes toward vaccination and preferences for reminder/recall. The objective of this study was to determine patient perspectives on adult vaccines generally; attitudes about Tdap, pneumococcal polysaccharide (PPSV-23), and seasonal influenza vaccines specifically; and preferences for adult reminder/recall delivery. Twelve focus groups were conducted with 68 patients in a safety net health system. The sample was stratified by preferred language (English or Spanish), age (18–64 or 65+), and health status (with or without chronic conditions). Participants expressed positive attitudes toward vaccines generally, but had little knowledge of specific vaccines other than influenza, about which they expressed concerns. Although none reported previous experience receiving reminder/recall notices for adult vaccines, all were in favor of receiving them. These results suggest potential patient interest in greater adoption of evidence-based methods to improve immunization rates, and highlight the need for improved communication between providers and patients about adult vaccines.

Beneficiary characteristics and vaccinations in the end-stage renal disease Medicare beneficiary population, an analysis of claims data 2006–2015

Vaccine
Volume 35, Issue 52  Pages 7213–7346 (19 December 2017)
http://www.sciencedirect.com/journal/vaccine/vol/35/issue/52

Beneficiary characteristics and vaccinations in the end-stage renal disease Medicare beneficiary population, an analysis of claims data 2006–2015
Original research article
Pages 7302–7308
Angela K. Shen, Jeffrey A. Kelman, Rob Warnock, Weiwei Zhang, … Bruce G. Gellin

Adjuvant Probiotics and the Intestinal Microbiome: Enhancing Vaccines and Immunotherapy Outcomes

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 16 December 2017)

Open Access  Review
Adjuvant Probiotics and the Intestinal Microbiome: Enhancing Vaccines and Immunotherapy Outcomes
by Luis Vitetta, Emma Tali Saltzman, Michael Thomsen, Tessa Nikov and Sean Hall
Vaccines 2017, 5(4), 50; doi:10.3390/vaccines5040050 – 11 December 2017
Abstract
Immune defence against pathogenic agents comprises the basic premise for the administration of vaccines. Vaccinations have hence prevented millions of infectious illnesses, hospitalizations and mortality. Acquired immunity comprises antibody and cell mediated responses and is characterized by its specificity and memory. Along a similar congruent yet diverse mode of disease prevention, the human host has negotiated from in utero and at birth with the intestinal commensal bacterial cohort to maintain local homeostasis in order to achieve immunological tolerance in the new born. The advent of the Human Microbiome Project has redefined an appreciation of the interactions between the host and bacteria in the intestines from one of a collection of toxic waste to one of a symbiotic existence. Probiotics comprise bacterial genera thought to provide a health benefit to the host. The intestinal microbiota has profound effects on local and extra-intestinal end organ physiology. As such, we further posit that the adjuvant administration of dedicated probiotic formulations can encourage the intestinal commensal cohort to beneficially participate in the intestinal microbiome-intestinal epithelia-innate-cell mediated immunity axes and cell mediated cellular immunity with vaccines aimed at preventing infectious diseases whilst conserving immunological tolerance. The strength of evidence for the positive effect of probiotic administration on acquired immune responses has come from various studies with viral and bacterial vaccines. We posit that the introduction early of probiotics may provide significant beneficial immune outcomes in neonates prior to commencing a vaccination schedule or in elderly adults prior to the administration of vaccinations against influenza viruses

ISPOR Code of Ethics 2017 (4th Edition)

Value in Health                   
December 2017 Volume 20, Issue 10, p1227-1440
http://www.valueinhealthjournal.com/current

ISPOR REPORTS
ISPOR Code of Ethics 2017 (4th Edition)
Jessica Santos, Francis Palumbo, Elizabeth Molsen-David, Richard J. Willke, Louise Binder, Michael Drummond, Anita Ho, William D. Marder, Louise Parmenter, Gurmit Sandhu, Asrul A. Shafie, David Thompson
Published online: December 1, 2017

Abstract
As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results.
There are nine chapters: 1 – Introduction; 2 – Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 – Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 – Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 – Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 – Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 – Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 – Publication and Dissemination; and 9 – Conclusion and Limitations.

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

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

Health Policy and Planning
Published: 11 December 2017
Social costs of illicit financial flows in low- and middle-income countries: the case of infant vaccination coverage
Bienvenido Ortega Jesús Sanjuán Antonio Casquero
https://doi.org/10.1093/heapol/czx170
Abstract
The liberalization of capital flows is generally associated with prospects of higher growth. However, in developing countries, opening the capital account may also facilitate the flow of capital out of the country through illicit financial flows (IFFs). Given that IFFs drain the scarce public resources available to finance the provision of public goods and services, the extent of illicit capital flows from developing countries is serious cause for concern. In this context, as a first step in analysing the social costs of IFFs in developing countries, this article studied the relationship between IFFs and infant immunization coverage rates. Data for 56 low- and middle-income countries for the period 2002–13 were used in the empirical analysis. The main result was that the relative level of IFFs to total trade negatively impacted vaccination coverage but only in the case of countries with very high levels of perceived corruption. In this case, the total effect of an annual 1 p.p. increase in the ratio of IFFs to total trade was to reduce the level of vaccination coverage rates over the coming years by 0.19 p.p. Given that there was an annual average of 18 million infants in this cluster of 25 countries, this result suggests that at least 34 000 children may not receive this basic health care intervention in the future as a consequence of this increase in IFFs in any particular year.

Pathogens
2017, 6(4), 65;
Differences of Rotavirus Vaccine Effectiveness by Country: Likely Causes and Contributing Factors
U Desselberger
doi:10.3390/pathogens6040065
Abstract
Rotaviruses are a major cause of acute gastroenteritis in infants and young children worldwide and in many other mammalian and avian host species. Since 2006, two live-attenuated rotavirus vaccines, Rotarix® and RotaTeq®, have been licensed in >100 countries and are applied as part of extended program of vaccination (EPI) schemes of childhood vaccinations. Whereas the vaccines have been highly effective in high-income countries, they were shown to be considerably less potent in low- and middle-income countries. Rotavirus-associated disease was still the cause of death in >200,000 children of <5 years of age worldwide in 2013, and the mortality is concentrated in countries of sub-Saharan Africa and S.E. Asia. Various factors that have been identified or suggested as being involved in the differences of rotavirus vaccine effectiveness are reviewed here. Recognition of these factors will help to achieve gradual worldwide improvement of rotavirus vaccine effectiveness.

Public Health
05 Dec 2017, 154:102-109
Self-reported influenza vaccination rates and attitudes towards vaccination among health care workers: results of a survey in a German university hospital.
MH Hagemeister, NK Stock, T Ludwig, P Heuschmann…
Abstract
The objective of this survey was to analyse vaccination rates and attitudes towards vaccination among health care workers (HCWs). The period prevalence of self-reported acute respiratory infections in the influenza season 2014/2015 was examined.A cross-sectional study was conducted among HCWs of a German university hospital using an anonymised questionnaire. Recruitment was performed by providing all medical and nursing staff a paper questionnaire with an invitation to participate.Descriptive aggregated data were generated from digitalised questionnaires for all variables. Differences in categorical variables were analysed by Chi-squared test. Textual data were analysed by an iterative process based on the grounded theory by Glaser and Strauss.The response rate was 31% (677/2186). Probable influenza was described by 9% (64/677) of the participants. The overall self-reported vaccination rate was 55% (366/666). Self-reported vaccination rate was higher in physicians (172/239, 72%) than in nursing staff (188/418, 45%). HCWs in paediatrics (103/148, 70%) more likely received vaccines than HCWs in surgery (31/84, 37%). Most vaccinations were provided by medical staff on the wards (164/368, 45%). Self-reported lost work-time due to adverse events after vaccination was low (6/336, 2%). Eight categories for vaccine refusal were identified, whereof doubts about effectiveness and indication of the vaccine was most frequently mentioned (72/202, 36%).Efforts to promote vaccination should focus on nursing staff and should provide scientific evidence on effectiveness, adverse effects, and the benefits of health care workers’ vaccination for patients. Administering vaccines at the workplace proved to be a successful strategy in our setting. Studies are needed to assess the frequency of influenza causing disease in HCWs.

Medical Decision Making : an International Journal of the Society for Medical Decision Making
DOI: 10.1177/0272989X17704858
Effects of Anti-Versus Pro-Vaccine Narratives on Responses by Recipients Varying in Numeracy: A Cross-sectional Survey-Based Experiment.
W de Bruin Bruine, A Wallin, AM Parker, J Strough…
Abstract
To inform their health decisions, patients may seek narratives describing other patients’ evaluations of their treatment experiences. Narratives can provide anti-treatment or pro-treatment evaluative meaning that low-numerate patients may especially struggle to derive from statistical information. Here, we examined whether anti-vaccine (v. pro-vaccine) narratives had relatively stronger effects on the perceived informativeness and judged vaccination probabilities reported among recipients with lower (v. higher) numeracy. Participants ( n=1,113) from a nationally representative US internet panel were randomly assigned to an anti-vaccine or pro-vaccine narrative, as presented by a patient discussing a personal experience, a physician discussing a patient’s experience, or a physician discussing the experiences of 50 patients. Anti-vaccine narratives described flu experiences of patients who got the flu after getting vaccinated; pro-vaccine narratives described flu experiences of patients who got the flu after not getting vaccinated. Participants indicated their probability of getting vaccinated and rated the informativeness of the narratives. Participants with lower numeracy generally perceived narratives as more informative. By comparison, participants with higher numeracy rated especially anti-vaccine narratives as less informative. Anti-vaccine narratives reduced the judged vaccination probabilities as compared with pro-vaccine narratives, especially among participants with lower numeracy. Mediation analyses suggested that low-numerate individuals’ vaccination probabilities were reduced by anti-vaccine narratives-and, to a lesser extent, boosted by pro-vaccine narratives-because they perceived narratives to be more informative. These findings were similar for narratives provided by patients and physicians. Patients with lower numeracy may rely more on narrative information when making their decisions. These findings have implications for the development of health communications and decision aids.

Media/Policy Watch

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.
 
 
The Atlantic
http://www.theatlantic.com/magazine/
Accessed 16 December 2017
40 Years Later, Some Survivors of the First Ebola Outbreak Are Still Immune
The antibodies in their blood might hold the key to future vaccines.
Ed Yong, Dec 14, 2017

New Yorker
http://www.newyorker.com/
Accessed 16 December 2017
A Reporter at Large
December 18 & 25, 2017 Issue
Ophelia Dahl’s National Health Service
Partners in Health wants to rebuild entire countries’ medical systems, and bring health care to some of the poorest people on earth.
By Ariel Levy
 
New York Times
http://www.nytimes.com/
Accessed 16 December 2017
Former Philippine President Defends Controversial Dengue Programme
By REUTERSDEC. 14, 2017, 6:45 A.M. E.S.T
 
Washington Post
http://www.washingtonpost.com/
Accessed 16 December 2017
Diphtheria deaths in Indonesia spark immunization campaign
Niniek Karmini | AP · · Dec 11, 2017

AKARTA, Indonesia — Indonesia is immunizing millions of children and teenagers against diphtheria after the disease killed 38 people, mostly children, since January.

Children in school uniforms and toddlers clinging to their parents received shots at a high school in Indonesia’s capital, Jakarta, on the first day of the campaign Monday.

Diphtheria is a bacterial disease that can cause breathing difficulties, heart failure and paralysis. It was more or less eradicated in Indonesia in the 1990s but health officials say it has re-emerged in the past four years because immunization rates have dropped, partly reflecting fears about vaccines.

The first stage of the $112 million campaign aims to vaccinate 8 million people under the age of 19 in Jakarta and the populous provinces of Banten and West Java.

The outbreak is “likely due to some people refusing immunization which causes their children’s antibodies and resistance to be low,” Health Minister Nila Moeloek said after visiting a hospital where more than more than 30 diphtheria patients were being treated…

Fifteen Years Isn’t That Long: The SDGs and Holistic Development

Think Tanks et al

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 16 December 2017
Fifteen Years Isn’t That Long: The SDGs and Holistic Development
Blog Post  12/15/17
Charles Kenny
Do the fifteen year targets of the SDGs stand in the way of their vision of integration and sustainability? If you wanted to achieve long term development progress, you’d probably focus on technology change, learning and innovation in policies, and improving institutional functioning. If you wanted to improve outcomes in fifteen years, you’d probably focus on throwing money at technical solutions. The problems with the second approach include that we don’t have the money, and the technical solutions won’t necessarily work best over the long term.

Vaccines and Global Health: The Week in Review 9 Dec 2017

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

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 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_9 Dec 2017

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

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

Milestones :: Perspectives

Milestones :: Perspectives
 
Editor’s Note:
WHO published a new Fact Sheet titled “Human rights and health” which we present below [full text]. In reading it, our perspective that full, life-course immunization is and should be the core of “health as a human right” was strengthened.
 
 
WHO Fact Sheet – Human rights and health
December 2017
Key facts
:: The WHO Constitution (1946) envisages “…the highest attainable standard of health as a fundamental right of every human being.”
:: Understanding health as a human right creates a legal obligation on states to ensure access to timely, acceptable, and affordable health care of appropriate quality as well as to providing for the underlying determinants of health, such as safe and potable water, sanitation, food, housing, health-related information and education, and gender equality.
:: A States’ obligation to support the right to health – including through the allocation of “maximum available resources” to progressively realise this goal – is reviewed through various international human rights mechanisms, such as the Universal Periodic Review, or the Committee on Economic, Social and Cultural Rights. In many cases, the right to health has been adopted into domestic law or Constitutional law.
:: A rights-based approach to health requires that health policy and programmes must prioritize the needs of those furthest behind first towards greater equity, a principle that has been echoed in the recently adopted 2030 Agenda for Sustainable Development and Universal Health Coverage. (1)
:: The right to health must be enjoyed without discrimination on the grounds of race, age, ethnicity or any other status. Non-discrimination and equality requires states to take steps to redress any discriminatory law, practice or policy.
:: Another feature of rights-based approaches is meaningful participation. Participation means ensuring that national stakeholders – including non-state actors such as non-governmental organizations – are meaningfully involved in all phases of programming: assessment, analysis, planning, implementation, monitoring and evaluation.

Introduction
“The right to the highest attainable standard of health” implies a clear set of legal obligations on states to ensure appropriate conditions for the enjoyment of health for all people without discrimination.

The right to health is one of a set of internationally agreed human rights standards, and is inseparable or ‘indivisible’ from these other rights. This means achieving the right to health is both central to, and dependent upon, the realisation of other human rights, to food, housing, work, education, information, and participation.

The right to health, as with other rights, includes both freedoms and entitlements:
:: Freedoms include the right to control one’s health and body (for example, sexual and reproductive rights) and to be free from interference (for example, free from torture and non-consensual medical treatment and experimentation).
:: Entitlements include the right to a system of health protection that gives everyone an equal opportunity to enjoy the highest attainable level of health.

Focus on disadvantaged populations
Disadvantage and marginalization serve to exclude certain populations in societies from enjoying good health. Three of the world’s most fatal communicable diseases – malaria, HIV/AIDS and tuberculosis – disproportionately affect the world’s poorest populations, and in many cases are compounded and exacerbated by other inequalities and inequities including gender, age, sexual orientation or gender identity and migration status. Conversely the burden of non-communicable diseases – often perceived as affecting high-income countries – is increasing disproportionately among lower-income countries and populations, and is largely associated with lifestyle and behaviour factors as well as environmental determinants, such as safe housing, water and sanitation that are inextricably linked to human rights.

A focus on disadvantage also reveals evidence of those who are exposed to greater rates of ill-health and face significant obstacles to accessing quality and affordable healthcare, including indigenous populations. While data collection systems are often ill-equipped to capture data on these groups, reports show that these populations have higher mortality and morbidity rates, due to noncommunicable diseases such as cancer, cardiovascular diseases, and chronic respiratory disease. These populations may also be the subject of laws and policies that further compound their marginalization and make it harder for them to access healthcare prevention, treatment, rehabilitation and care services.

Violations of human rights in health
Violations or lack of attention to human rights can have serious health consequences. Overt or implicit discrimination in the delivery of health services – both within the health workforce and between health workers and service users – acts as a powerful barrier to health services, and contributes to poor quality care.

Mental ill-health often leads to a denial of dignity and autonomy, including forced treatment or institutionalization, and disregard of individual legal capacity to make decisions. Paradoxically, mental health is still given inadequate attention in public health, in spite of the high levels of violence, poverty and social exclusion that contribute to worse mental and physical health outcomes for people with mental health disorders.

Violations of human rights not only contribute to and exacerbate poor health, but for many, including people with disabilities, indigenous populations, women living with HIV, sex workers, people who use drugs, transgender and intersex people, the health care setting presents a risk of heightened exposure to human rights abuses – including coercive or forced treatment and procedures.

Human rights-based approaches
A human rights-based approach to health provides a set of clear principles for setting and evaluating health policy and service delivery, targeting discriminatory practices and unjust power relations that are at the heart of inequitable health outcomes.

In pursuing a rights-based approach, health policy, strategies and programmes should be designed explicitly to improve the enjoyment of all people to the right to health, with a focus on the furthest behind first. The core principles and standards of a rights-based approach are detailed below.

Core principles of human rights
Accountability
States and other duty-bearers are answerable for the observance of human rights. However, there is also a growing movement recognising the importance of other non-state actors such as businesses in the respect and protection of human rights. (2)

Equality and non-discrimination
The principle of non-discrimination seeks ‘…to guarantee that human rights are exercised without discrimination of any kind based on race, colour, sex, language, religion, political, or other opinion, national or social origin, property, birth or other status such as disability, age, marital and family status, sexual orientation and gender identity, health status, place of residence, economic and social situation’.

Any discrimination, for example in access to health care, as well as in means and entitlements for achieving this access, is prohibited on the basis of race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth, physical or mental disability, health status (including HIV/AIDS), sexual orientation ,and civil, political, social or other status, which has the intention or effect of impairing the equal enjoyment or exercise of the right to health.

The principle of non-discrimination and equality requires WHO to address discrimination in guidance, policies, and practices, such as relating to the distribution and provision of resources and health services. Non-discrimination and equality are key measures required to address the social determinants affecting the enjoyment of the right to health. Functioning national health information systems and availability of disaggregated data are essential to be able to identify the most vulnerable groups and diverse needs.

Participation
Participation requires ensuring that all concerned stakeholders including non-state actors have ownership and control over development processes in all phases of the programming cycle: assessment, analysis, planning, implementation, monitoring, and evaluation. Participation goes well beyond consultation or a technical addition to project design; it should include explicit strategies to empower citizens, especially the most marginalized, so that their expectations are recognised by the State.

Participation is important to accountability as it provides “…checks and balances which do not allow unitary leadership to exercise power in an arbitrary manner”.

Universal, indivisible and interdependent
Human rights are universal and inalienable. They apply equally, to all people, everywhere, without distinction. Human Rights standards – to food, health, education, to be free from torture, inhuman or degrading treatment – are also interrelated. The improvement of one right facilitates advancement of the others. Likewise, the deprivation of one right adversely affects the others.

Core elements of a right to health
Progressive realization using maximum available resources
No matter what level of resources they have at their disposal, progressive realisation requires that governments take immediate steps within their means towards the fulfilment of these rights. Regardless of resource capacity, the elimination of discrimination and improvements in the legal and juridical systems must be acted upon with immediate effect.

Non-retrogression
States should not allow the existing protection of economic, social, and cultural rights to deteriorate unless there are strong justifications for a retrogressive measure. For example, introducing school fees in secondary education which had formerly been free of charge would constitute a deliberate retrogressive measure. To justify it, a State would have to demonstrate that it adopted the measure only after carefully considering all the options, assessing the impact and fully using its maximum available resources.

Core components of the right to health
The right to health (Article 12) was defined in General Comment 14 of the Committee on Economic, Social and Cultural Rights – a committee of Independent Experts, responsible for overseeing adherence to the Covenant. (4) The right includes the following core components:

Availability
Refers to the need for a sufficient quantity of functioning public health and health care facilities, goods and services, as well as programmes for all. Availability can be measured through the analysis of disaggregated data to different and multiple stratifiers including by age, sex, location and socio-economic status and qualitative surveys to understand coverage gaps and health workforce coverage

Accessibility
Requires that health facilities, goods, and services must be accessible to everyone. Accessibility has four overlapping dimensions:
:: non-discrimination
:: physical accessibility
:: economical accessibility (affordability)
:: information accessibility.

Assessing accessibility may require analysis of barriers – physical financial or otherwise – that exist, and how they may affect the most vulnerable, and call for the establishment or application of clear norms and standards in both law and policy to address these barriers, as well as robust monitoring systems of health-related information and whether this information is reaching all populations.

Acceptability
Relates to respect for medical ethics, culturally appropriate, and sensitivity to gender. Acceptability requires that health facilities, goods, services and programmes are people-centred and cater for the specific needs of diverse population groups and in accordance with international standards of medical ethics for confidentiality and informed consent.

Quality
Facilities, goods, and services must be scientifically and medically approved. Quality is a key component of Universal Health Coverage, and includes the experience as well as the perception of health care. Quality health services should be:
:: Safe – avoiding injuries to people for whom the care is intended;
:: Effective – providing evidence-based healthcare services to those who need them;
:: People-centred – providing care that responds to individual preferences, needs and values;
:: Timely – reducing waiting times and sometimes harmful delays.
:: Equitable – providing care that does not vary in quality on account of gender, ethnicity, geographic location, and socio-economic status;
:: Integrated – providing care that makes available the full range of health services throughout the life course;
:: Efficient – maximizing the benefit of available resources and avoiding waste

WHO response
WHO has made a commitment to mainstream human rights into healthcare programmes and policies on national and regional levels by looking at underlying determinants of health as part of a comprehensive approach to health and human rights.

In addition, WHO has been actively strengthening its role in providing technical, intellectual, and political leadership on the right to health including:
:: strengthening the capacity of WHO and its Member States to integrate a human rights-based approach to health;
:: advancing the right to health in international law and international development processes; and
:: advocating for health-related human rights, including the right to health.

Addressing the needs and rights of individuals at different stages across the life course requires taking a comprehensive approach within the broader context of promoting human rights, gender equality, and equity.

As such, WHO promotes a concise and unifying framework that builds on existing approaches in gender, equity, and human rights to generate more accurate and robust solutions to health inequities. The integrated nature of the framework is an opportunity to build on foundational strengths and complementarities between these approaches to create a cohesive and efficient approach to promote health and well-being for all.

References

  1. Transforming our World: The 2030 Agenda for Sustainable Development.
    UN General Assembly. 2015. 21 October. UN Doc. A/RES/70/1.
  2. General comment No. 20: Non-discrimination in economic, social and cultural rights
    Committee on Economic, Social and Cultural Rights. 2009.
  3. Guiding principles for business and human rights, Implementing the United Nations “Protect, Respect and Remedy” Framework
    Office of the high Commissioner for Human Rights, Geneva, 2011.

CESCR General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12)
CESCR (Committee on Economic, Social, and Cultural Rights). 2000. ). 11 August. Doc. E/C.12/2000/4.

Dengue Vaccine – Dengvaxia Update

Dengue Vaccine – Dengvaxia Update
 
Philippines Food and Drug Administration
FDA Advisory No. 2017-318 || Suspension of Sale/Marketing/Distribution of Sanofi Pasteur, Inc.’s Tetravalent Vaccine (Live, Attenuated)(Dengvaxia)
04 December 2017
On 29 November 2017, Sanofi Pasteur, Inc. (Sanofi) released an advisory providing updated information on the Dengue Tetravalent Vaccine (Live, Attenuated), the drug locally registered as Dengvaxia. The advisory contained information on the completion of a post-clinical trial study of the said product indicating potential risk to patients who have not had dengue prior to immunization.
In order to protect the general public, the Food and Drug Administration (FDA) immediately directed Sanofi to SUSPEND the sale/distribution/marketing of Dengvaxia and cause the WITHDRAWAL of Dengvaxia in the market pending compliance with the directives of the FDA. Sanofi was further directed to conduct an information dissemination campaign through Advisories, Dear Doctor Letters and Patient fora.
The FDA is closely coordinating with the Department of Health (DOH) for any adverse events/ reactions that may be reported by the recipients following their immunization of the Dengvaxia, and will immediately take appropriate measures to protect the public.
All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post marketing surveillance of Dengvaxia, by reporting to FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person.
 
Sanofi ordered to pull Dengvaxia in Philippines as safety episode escalates
by Eric Sagonowsky | Fierce Pharma
Dec 5, 2017 9:15am
…In a Monday advisory, the Philippines’ FDA wrote that it directed Sanofi to “suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA.”
The Philippines is the only country now conducting a Dengvaxia vaccination campaign. The effort is focused on areas within the country with high levels of dengue infection.
A Sanofi spokesperson told FiercePharma the company has been “informed of the position of the Philippine Food and Drug Administration … and will work with them to review the implementation of their direction. We will continue to seek constructive and transparent dialogue with them.”
The order comes right after Sanofi issued an advisory about the risks of the shot in recipients with no prior dengue infection. In those patients, the shot can cause more serious dengue infections. To get the word out, the regulators in the Philippines also ordered Sanofi to “conduct an information dissemination campaign,” with public advisories and communications with doctors and patients.
Based on data at hand, Sanofi estimated 1 in 800 dengue infections would be severe among unvaccinated people. In the new analysis of a five-year follow-up study, the increased risk translated to two more cases of “severe dengue” per 1,000 people who had not been exposed to the virus, the company’s spokesperson told FiercePharma. All recovered with treatment….
 
Philippines Orders Probe Into Vaccine, Sanofi Says No Deaths Reported
New York Times/Reuters | 3 December 2017
MANILA — The Philippines ordered a probe on Monday into the immunisation of more than 730,000 children with a dengue vaccine that has since been suspended, while French drug company Sanofi said no deaths had been reported as a result of the programme.
“As far as we know, as far as we are made aware, there are no reported deaths that are related to dengue vaccination,” Ruby Dizon, medical director at Sanofi Pasteur Philippines, told a news conference in Manila.
“Of course, rest assured, monitoring is continuing, we are working with the Department of Health (DOH), in collaboration, to make sure this is maintained.”…
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Emergencies

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 6 December 2017 [GPEI]
:: The Islamic Advisory Group has recently launched a training manual on polio eradication, mother and child health, and immunization.
:: The latest semi-annual status report for the Global Polio Eradication Initiative has been released, covering progress made between January and June 2017.

:: The WHO Executive Board has released a report providing an update on the status of the four objectives of the Polio Eradication and Endgame Strategic Plan.

:: Summary of newly-reported viruses this week:
No new confirmed cases.
Afghanistan: One new wild poliovirus type 1 (WPV1) positive environmental sample, collected from Kandahar province
Pakistan: Two new wild poliovirus type 1 (WPV1) positive environmental samples, one collected from Khyber Pakhtunkhwa province, and one from Sindh province.one new wild poliovirus type 1 (WPV1) case, from Nangarhar province.

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Semi-annual Status Report – January to June 2017PROGRESS AGAINST THE POLIO ERADICATION & ENDGAME STRATEGIC PLAN
Global Polio Eradication Initiative
WHO  2017 :: 36 pages
EXECUTIVE SUMMARY
At the beginning of 2017, progress continued towards each of the Endgame Plan’s four objectives. The world has never been closer to eradicating polio, with fewer cases in fewer areas of fewer countries than at any time in the past.

Pakistan and Afghanistan continued to intensify eradication efforts and implement their respective national emergency action plans, overseen by each country’s head of state. They continued to treat the virus transmission as a single epidemiological block and focused on coordinating activities in both countries.

In Nigeria, and across the Lake Chad subregion, outbreak response persisted in reaction to the detection of wild poliovirus type 1 (WPV1) in Borno in August 2016, Nigeria, the first WPV detected in the country since 2014. It was a sobering reminder of the fragility of progress and of the dangers of subnational surveillance gaps and low-level residual transmission. Although no new cases have been reported from Nigeria since last August, undetected ongoing transmission was assumed in parts of Borno as it remains inaccessible.

In May 2017, confirmation was received of new circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks in both the Syrian Arab Republic and the Democratic Republic of the Congo. The emergence of new cVDPV2 in the 12- to 18-month period following the globally coordinated switch from trivalent oral polio vaccine (tOPV) to bivalent oral polio vaccine (bOPV) in April 2016 was anticipated, with the most at-risk areas foreseen to be those with weak health systems, insecurity or inaccessibility. In preparation for the anticipated risks, internationally-agreed outbreak response protocols had been established to rapidly address cVDPV2 in the post-switch era, including by maintaining a global stockpile of monovalent OPV type 2 (mOPV2). An outbreak response is now under way in both countries to rapidly stop these strains. In the Syrian Arab Republic, the same response strategies were employed that successfully stopped a WPV1 outbreak in the same area of the country in 2013/2014.

These outbreaks underscored the continued risk posed by immunity gaps anywhere in the world, more than any risks associated with the vaccine. In areas of adequate immunity levels, surveillance for type 2 polioviruses from any source revealed a steady and rapid decline of these strains’ persistence. These outbreaks are tragic, in particular for the children who have so far been paralysed by these strains, and emphasize the urgent need to fully withdraw all tOPV stock everywhere. By extension, it also highlights the need to fully withdraw all OPV use, once the remaining strains of WPVs (types 1 and 3) have been declared as eradicated.

A global supply constraint of inactivated polio vaccine (IPV) continued to be managed carefully, allocating available supply to areas deemed at highest risk of cVDPV2 emergence. Increasing clinical evidence indicates that fractional dose IPV provides equal (and in a two-dose schedule, even superior) protection to full dose IPV, but this approach is already stretching limited supply.

On containment, the GPEI continued to work with countries to accelerate efforts to identify all facilities retaining poliovirus stock, reduce their number to an absolute minimum and put in place all necessary biosafety conditions to ensure the safe handling of all residual stock.

Polio transition planning will continue to be intensified through 2017. The 16 countries with the greatest polio-funded infrastructure drafted and are finalizing their transition plans. Transition planning and implementation are being conducted in such a manner as to minimize any associated programme-related risks and to ensure that a successful and lasting polio-free world will be achieved as rapidly and efficiently as possible. A post-certification strategy, request by Member States at the May 2017 World Health Assembly, is being developed and will be presented to the World Health Assembly in 2018, specifying the global technical standards that will be needed after the certification of wild poliovirus eradication to maintain a polio-free world.

Thanks to the generous continuing support of the international development community, including Member States (especially the countries where poliomyelitis is endemic and the generous donors to the GPEI) as well as multilateral and bilateral organizations, development banks, foundations and Rotary International, the budget for 2017 for planned activities was fully financed. At an extraordinary pledging moment at the Rotary International convention in June 2017 in Atlanta, USA, numerous public- and private-sector partners from around the world joined Rotary in announcing new commitments, bringing total pledges against the additional US$ 1.5 billion budget to US$ 1.2 billion. Securing a lasting polio-free world will not only be associated with significant humanitarian and global health benefits but also with economic advantages, as eradicating polio worldwide will result in global savings of US$ 50 billion.
 
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Syria cVDPV2 outbreak situation report 25: 6 December 2017
Situation update 6 December 2017
:: No new cases of cVDPV2 were reported this week. The most recent case (by date of onset) is 9 September 2017 from Mayadeen district.
:: The total number of confirmed cVDPV2 cases remains 70.
:: Planning continues for the second phase of the outbreak response. The Syrian Ministry of Health has requested additional doses of mOPV2 and IPV for two further immunization rounds.
::Training of health staff for the assessment of cold chain capacity across the country is ongoing in Damascus. Health staff have been trained on mobile data collection. All accessible health facilities will be assessed starting 10 December.

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WHO Grade 3 Emergencies  [to 9 December 2017]
The Syrian Arab Republic
:: Syria cVDPV2 outbreak situation report 25: 6 December 2017
[See Polio above for detail]

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WHO Grade 2 Emergencies  [to 9 December 2017]
Myanmar
:: Diphtheria is spreading fast in Cox’s Bazar, Bangladesh
News release
6 December 2017 | Geneva – Diphtheria is rapidly spreading among Rohingya refugees in Cox’s Bazar, Bangladesh, WHO warned today.
More than 110 suspected cases, including 6 deaths, have been clinically diagnosed by health partners, including Médecins Sans Frontières (MSF) and the International Federation of the Red Cross (IFRC).
“These cases could be just the tip of the iceberg. This is an extremely vulnerable population with low vaccination coverage, living in conditions that could be a breeding ground for infectious diseases like cholera, measles, rubella, and diphtheria,” said Dr Navaratnasamy Paranietharan, WHO Representative to Bangladesh.
“This is why we have protected more than 700,000 people with the oral cholera vaccine, as well as more than 350,000 children with measles-rubella vaccine in a campaign that ended yesterday. Now we have to deal with diphtheria.”…

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: 7 Dec 2017   Syria IDP Operations Summary 2017 (Valid as of 7/12/2017) [EN/AR]

Yemen 
:: 4 Dec 2017  Statement by the Humanitarian Coordinator for Yemen, Jamie McGoldrick, Requesting a Humanitarian Pause [EN/AR]
:: Yemen: 2018 Humanitarian Needs Overview (HNO)
:: Yemen: Escalation of Armed Clashes and Airstrikes in Sana’a City – Update 1 | 04 December 2017
:: Statement by IASC Principals requesting the immediate lifting of the blockade | 2 December 2017
 
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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
ROHINGYA CRISIS
:: ISCG Situation Update: Rohingya Refugee Crisis, Cox’s Bazar – 07 December 2017
 
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WHO & Regional Offices [to 9 December 2017]
Uganda ends Marburg virus disease outbreak
News release
8 December 2017 | Geneva – Uganda has successfully controlled an outbreak of Marburg virus disease and prevented its spread only weeks after it was first detected, the World Health Organization said on Friday (December 8).
“Uganda has led an exemplary response. Health authorities and partners, with the support of WHO, were able to detect and control the spread of Marburg virus disease within a matter of weeks,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.
The Ugandan Ministry of Health notified WHO of the outbreak on October 17, after laboratory tests confirmed that the death of a 50-year-old woman was due to infection with the Marburg virus. A Public Health Emergency Operations Centre was immediately activated and a national taskforce led the response.
Three people died over the course of the outbreak which affected two districts in eastern Uganda near the Kenyan border, Kween and Kapchorwa. Health workers followed up with a total 316 close contacts of the patients in Uganda and Kenya to ensure that they had not acquired the illness…

Diphtheria is spreading fast in Cox’s Bazar, Bangladesh
6 December 2017 – Diphtheria is rapidly spreading among Rohingya refugees in Cox’s Bazar, Bangladesh, WHO warned today. More than 110 suspected cases, including 6 deaths, have been clinically diagnosed by health partners, including Médecins Sans Frontières (MSF) and the International Federation of the Red Cross (IFRC).

Highlights
The Latvian eHealth Journey
December 2017 – In a journey that started over a decade ago, and in line with the 2013 World Health Assembly resolution on eHealth standardization and interoperability, the Ministry of Health of Latvia demonstrated its commitment to achieving Universal Health Coverage by creating a national programme of eHealth – which was seen as a key effort in ensuring that Latvian people receive the right care in the right place and time. The WHO Country Office in Latvia has provided coordination and technical support for Latvia’s eHealth efforts.

Recruitment for external members for WHO’s Guideline Review Committee
December 2017 – The WHO Guideline Review Committee (GRC) seeks new external members for the 2018-2020 term. The GRC oversees WHO’s quality assurance process for all of its guidelines (information products that contain technical recommendations across a wide variety of topics). GRC members serve a 3-year term and involves 40-50 hours of work per year, including virtual attendance at ten 2-hour monthly meetings and the performance of peer review of 3-4 documents.

New guidance on insecticide resistance monitoring and management
December 2017 – This framework provides guidance on developing a national insecticide resistance monitoring and management plan. It is designed to help countries ensure adherence to the Global plan for insecticide resistance management in malaria vectors.

WHO commends South African parliament decision to pass tax bill on sugary drinks
December 2017 – The South African Parliament has taken a brave and powerful step towards promoting the health of the country’s citizens and reducing diet-related noncommunicable diseases (NCDs), such as diabetes, by passing a bill to implement a tax on sugar-sweetened beverages, according to Dr Rufaro Chatora, WHO’s Representative to South Africa.

Fact Sheets
:: Meningococcal meningitis  Updated December 2017
:: Human rights and health  December 2017
:: Cholera   Updated December 2017
:: Dementia  Updated December 2017
:: Mental health of older adults  Updated December 2017

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Weekly Epidemiological Record, 8 December 2017, vol. 92, 49 (pp. 749–760)
Schistosomiasis and soil-transmitted helminthiases: number of people treated in 2016
 
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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: The Marburg Virus Disease outbreak in Uganda is over   08 December 2017
:: Experts Call for Increased Investments to Drive Immunization Progress in Africa   08 December 2017
:: Momentum grows towards improved reproductive health services :  Experts pledge renewed commitment to scale up access to reproductive health services  08 December 2017
:: WHO supports ministry of health to train district rapid response teams in malaria surveillance, epidemic preparedness and response
:: WHO commends South African parliament decision to pass tax bill on sugary drinks  06 December 2017
:: World AIDS Day in South Sudan heightens campaigns to end AIDS by 2030  06 December 2017
:: With threat of famine looming for 2018, WHO helps worst cases of malnutrition in children in South Sudan   05 December 2017
:: Men urged to seek HIV & AIDS services at the World AIDS Day 2017 commemoration in Uganda  05 December 2017
:: WHO with support from Government of Japan strengthens blood transfusion services for safe, sustainable and quality blood in South Sudan  04 December 2017
:: Supporting breastfeeding to boost child survival  04 December 2017
:: South Sudan implements a road map to introduce and institutionalize National Health Accounts  04 December 2017
:: Botswana conducts a Joint External Evaluation to assess the country’s International Health Regulations (2005) core capacities  04 December 2017
:: The biggest AIDS Conference in Africa, opens in Abidjan, Cote d’Ivoire  03 December 2017
:: Dr Moeti calls for greater commitment to access, diagnosis and treatment for children and adolescents living with HIV/AIDS  03 December 2017
:: HIV experts take stock of progress and challenges in tackling HIV among children and young adults, ahead of ICASA   03 December 2017

WHO South-East Asia Region SEARO
:: Amid concern over drug resistance, Mekong countries call for accelerated action to eliminate malaria before 2030   SEAR/PR/1673
NAY PYI TAW, Myanmar 8 December 2017 – Representatives from Cambodia, China, the Lao People’s Democratic Republic, Myanmar, Thailand and Viet Nam today called for accelerated action to eliminate malaria in the Greater Mekong Subregion (GMS) by the year 2030.
The call comes amid concern over resistance of malaria parasites to antimalarial drugs, including artemisinin—the core compound of the best available antimalarial medicines. To date, resistance has been detected in five of the six GMS countries. The best way to address the threat posed by drug resistance is to eliminate malaria altogether from the countries of the Mekong.
At a high-level meeting convened by the Ministry of Health and Sports of Myanmar in collaboration with the World Health Organization (WHO) and the Asia Pacific Leaders Malaria Alliance (APLMA), representatives from the six GMS countries stressed that eliminating malaria in the Subregion requires urgent and coordinated action, with support from implementing agencies, funders and other partners.
Ministers from the six countries pledged to:
…ensure activities to eliminate malaria in the subregion are fully funded, including with more domestic funds;
…improve cross-border collaboration and establish an independent oversight body, for which WHO will act as the secretariat;
..strengthen systems for the identification and timely reporting of malaria infections, including drug-resistant forms;
…provide the best possible prevention, diagnosis and care for all people at risk of malaria, including free services for ethnic minorities and mobile and migrant populations, as part of universal health coverage;
..ensure available antimalarial medicines are safe and effective for use;
…bring all concerned sectors together to translate policies into time-bound and results-oriented actions; and
..engage communities in malaria elimination using innovative communication tools…
 
WHO European Region EURO
:: Challenging the supply chain to reduce sugar in foods 05-12-2017

WHO Western Pacific Region
:: Amid concern over drug resistance, Mekong countries call for accelerated action to eliminate malaria before 2030   SEAR/PR/1673

CDC/ACIP [to 9 December 2017]

CDC/ACIP [to 9 December 2017]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for December 7, 2017
Update: Influenza Activity in the United States
Since influenza activity is just beginning to increase, receiving influenza vaccine at this time should still offer substantial public health benefit. Health care providers should recommend influenza vaccine now and throughout the influenza season to all unvaccinated people 6 months and older who do not have contraindications. Prescription antiviral medications can treat influenza illness and are recommended for use in patients who are very sick with influenza or who are sick and at high risk of serious influenza complications. Influenza antiviral drugs can lessen duration and severity of illness and help prevent more severe illness. Influenza activity in the United States remained low during October 2017 but has been increasing since early November with influenza A (H3N2) viruses being most frequently identified. Almost all influenza viruses collected so far are similar to the cell-derived reference viruses representing 2017–18 season influenza vaccines. Annual vaccination varies in its effectiveness but it is the best available method for preventing influenza and its complications. Since the 2017-18 influenza season is just beginning, receiving an influenza vaccine now should still offer substantial public health benefit. Anyone who has not yet been vaccinated should get vaccinated as soon as possible. Influenza antiviral treatment, an adjunct to vaccination, can lessen duration and severity of illness. Antiviral drugs work best when started within two days of illness.

Progress Toward Global Eradication of Dracunculiasis, January 2016–June 2017
With only 25 Dracunculiasis cases in humans reported in 2016, the goal of eradicating Guinea worm disease appears to be on the horizon. However, infections in dogs and insecurity in Mali and South Sudan remain challenges to eradication efforts. Dracunculiasis, also known as Guinea worm disease, is a parasitic infection targeted for global eradication. Annual cases declined from about 3.5 million in 20 countries in 1986 to just 25 in 2016 from only 19 villages in Chad, Ethiopia, and South Sudan. In Chad, dog infections have far outnumbered human cases since 2012. In the first 6 months of 2017, however, there were fewer dog infections in Chad compared with the same period in 2016. While the world is closer than ever to Guinea worm eradication, infections in dogs and insecurity in Mali and South Sudan continue to be a challenge.

Announcements

Announcements

EDCTP    [to 9 December 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
8 December 2017
EDCTP 2018 Prizes: Call for nominations
EDCTP opens the call for nominations for its 2018 Prizes today…The EDCTP prizes recognise outstanding individuals and research teams from Africa and Europe who have made significant contributions to health research. In addition to their scientific excellence, the awardees will have made major contributions to the EDCTP objectives of strengthening clinical research capacity in Africa and supporting South-South and North-South networking.

8 December 2017
EDCTP and Global Health Innovative Technology Fund partnership
The Global Health Innovative Technology Fund (GHIT) and the European & Developing Countries Clinical Trials Partnership (EDCTP) announced a new partnership today, 8 December 2017, to support product development research. The partners’ first action will be co-funding the PZQ4PSAC phase III clinical study, which is sponsored by Merck KGaA and conducted by the Pediatric Praziquantel Consortium…

European Medicines Agency  [to 9 December 2017]
http://www.ema.europa.eu/ema/
04/12/2017
Call for patient organisation representatives to join the Committee for Orphan Medicines
Deadline for applications is 20 December 2017 …

European Vaccine Initiative  [to 9 December 2017]
http://www.euvaccine.eu/news-events
05 December 2017
New Project Manager vacancy at EVI
EVI has an exciting new Project Manager position. Deadline for applications: 15th January 2018, 17:00 CET.
 
 
FDA [to 9 December 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
December 07, 2017 –
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation

December 07, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation

 
Fondation Merieux  [to 9 December 2017]
http://www.fondation-merieux.org/
December 4, 2017
The Center on Infectiology Lao Christophe Merieux Hosts Workshops on HIV and Viral Hepatitis, Organized by Merieux Foundation
The Mérieux Foundation organized two workshops in Vientiane, Laos: one on viral hepatitis, November 22-24, and the other on HIV, November 29-30. They brought together nearly 150 people to address these major public health issues in Laos and neighboring countries.
 
 
GHIT Fund   [to 9 December 2017]
https://www.ghitfund.org/
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical ·
Press Room
EDCTP and Global Health Innovative Technology Fund partnership for the development of a paediatric formulation for schistosomiasis
2017.12.08
The European & Developing Countries Clinical Trials Partnership (EDCTP) and The Global Health Innovative Technology Fund (GHIT) announced a new partnership today, 8 December 2017, to support product development research. The partners’ first action will be co-funding the PZQ4PSAC phase III clinical study, which is sponsored by Merck KGaA and conducted by the Pediatric Praziquantel Consortium. This study will provide clinical data and support for registration of a new praziquantel (PZQ) tablet formulation to treat schistosomiasis in preschool-aged children (PSAC). EDCTP will be contributing €1,99M1 and GHIT €3,22M2 to the study consortium for a total project value of €12,10M including in-kind and cash contributions by all related parties.
“The joint investment in this project reflects the true value of global partnership with a noble goal of creating local solutions in disease endemic countries.  Moreover, this pivotal study aims to generate valuable evidence and support for registration of a paediatric formulation for preschool-aged children against schistosomiasis, thus addressing a neglected population and disease – the EDCTP programme embraces populations often excluded from clinical studies but with major unmet medical needs.” said, Dr Michael Makanga, EDCTP Executive Director…

 
Global Fund [to 9 December 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund, ADB Sign MOU to Help Countries in Asia Strengthen Health Systems to Fight HIV, Tuberculosis and Malaria
08 December 2017
NAY PYI TAW, Myanmar – The Global Fund and the Asian Development Bank (ADB) have signed a memorandum of understanding to support the financing, design and implementation of country-led programs to fight HIV, tuberculosis and malaria, and build resilient health systems in ADB member countries eligible for Global Fund financing.
Through a framework of mutual cooperation, ADB and the Global Fund can complement each other’s contributions to health programs in the Asia and Pacific region.
“The agreement exemplifies the Global Fund’s commitment to strategic partnerships with multilateral development banks,” said Marijke Wijnroks, Interim Executive Director of the Global Fund. “Development finance institutions like ADB can augment the impact and footprint of Global Fund grants by leveraging additional investment, building financial sustainability, and reinforcing transparency.”…
 
 
IVI   [to 9 December 2017]
http://www.ivi.int/
[Undated]
International Vaccine Institute joins the JEE Alliance
The International Vaccine Institute (IVI) joined the JEE Alliance (Alliance for Country Assessments for Global Health Security and IHR Implementation) on November 14, 2017.
The JEE Alliance is a multi-sectoral platform for international cooperation to promote political, financial and technical support for implementation of the International Health Regulations (2005), which was launched in Geneva, Switzerland in May 2016. The alliance brings together like-minded players from relevant sectors in countries, organizations and other stakeholders involved in health security. As of November 2017, the alliance had 65 members including governments, international organizations, financial institutions, NGOs and a group of private sector organizations.
“IVI’s experience in and commitment to health security is a valuable contribution to the JEE Alliance. We look forward to IVI’s active participation in the JEE Alliance initiatives” co-chairs Ambassador Blair Exell and Dr Päivi Sillanaukee of the Alliance said in a letter to IVI.
Dr. Jerome Kim, Director General of IVI, said, “As an organization concerned with the development of vaccines for global health security, we are pleased to join the JEE Alliance and have a chance to promote vaccine R&D and vaccination as a critical component of global health security, and partner with other parties to contribute to health security.”
 
 
JEE Alliance  [to 9 December 2017]
https://www.jeealliance.org/
1.12.2017
International Vaccine Institute (IVI) joins the JEE Alliance
 
 
MSF/Médecins Sans Frontières  [to 9 December 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Yemen: Warring Parties Show New Level of Disregard for Suffering Civilians
December 06, 2017
SANA’A/HAJJAH, YEMEN—The warring parties in Yemen are showing a whole new level of disregard for civilians, as heavy street fighting and airstrikes have paralyzed Sana’a, leaving the wounded without safe access to medical care. Meanwhile, a crippling blockade prevents vital supplies from entering the country, the international medical humanitarian organization Doctors Without Borders Médecins Sans Frontières (MSF) said today.
 
 
NIH  [to 9 December 2017]
http://www.nih.gov/news-events/news-releases
December 4, 2017
Gene-based Zika vaccine is safe and immunogenic in healthy adults
— Vaccine developed by NIH scientists shows promise in Phase 1 testing
Results from two Phase 1 clinical trials show an experimental Zika vaccine developed by government scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is safe and induces an immune response in healthy adults. The findings will be published on Dec. 4 in The Lancet. NIAID is currently leading an international effort to evaluate the investigational vaccine in a Phase 2/2b safety and efficacy trial…

Trials show inactivated Zika virus vaccine is safe and immunogenic
December 4, 2017 — Results support further clinical development.
 

UNAIDS [to 9 December 2017]
http://www.unaids.org/en
Press statement
Message on the occasion of Human Rights Day
10 December 2017
Michel Sidibé
Executive Director of UNAIDS

Under-Secretary-General of the United Nations
The advances in the response to HIV have been unprecedented. In South Africa in 2000, just 90 people had access to antiretroviral therapy. Today, South Africa has the largest treatment programme in the world, with 4.2 million people living with HIV in the country now on treatment. We have exceeded global targets and today around the world 20.9 million people have access to life-saving HIV medicines.
However, we cannot be complacent—AIDS is not over in any part of the world and the challenges ahead remain significant. Studies from 19 countries show that approximately one in five people living with HIV had been denied health care (including dental care, family planning services or sexual and reproductive health services). Data from eight countries show that 25% of people living with HIV avoided going to hospital because they feared stigma or discrimination related to their HIV status, and one in three women living with HIV had experienced at least one form of discrimination in health-care settings related to their sexual and reproductive health…

Press release
UNAIDS and IOM renew partnership agreement to promote access to HIV services for migrants and crisis-affected populations
GENEVA, 8 December 2017—UNAIDS and the International Organization for Migration (IOM) today signed a new cooperation agreement to promote access to HIV prevention, treatment, care and support services for migrants, mobile populations and people affected by humanitarian emergencies.
“Migrants and people displaced through conflict or emergencies must be supported and enabled through their journeys to exercise their right to health,” said Michel Sidibé, Executive Director of UNAIDS. “This new partnership agreement between UNAIDS and the International Organization for Migration will be essential in strengthening our efforts to make sure that no one is left behind.”

6 December 2017
PEPFAR announces continued progress against HIV

UNICEF  [to 9 December 2017]
https://www.unicef.org/media/
5 December 2017
West and Central Africa left behind in Global HIV response
ABIDJAN/DAKAR/NEW YORK/GENEVA, 5 December 2017 – More than four decades into the HIV epidemic, four in five children living with HIV in West and Central Africa are still not receiving life-saving antiretroviral therapy, and AIDS-related deaths among adolescents aged 15-19 are on the rise, according to a new report released today.

Wellcome Trust  [to 9 December 2017]
https://wellcome.ac.uk/news
News / Published: 5 December 2017
Six new partnerships to translate research into treatments
Today, we’re announcing collaborations with six institutions to find new ways to translate scientific discoveries into real world impact.
We are committing £6 million to these first translational partnerships with the universities of Bristol, Cambridge, Edinburgh, Manchester, Imperial College and Oxford through the Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok.
Researchers can face a number of barriers to taking the first step to translating their research – and often need more than financial support, including mentorship and regulatory advice.
Making the transition between discovery science and translation easier is one of the core aims of Wellcome’s Innovation for Impact [PDF 200KB].
Earlier this year, we set out a series of commitments – Transforming UK translation [PDF 99KB] – together with the Royal Society, Academy of Medical Sciences and Royal Academy of Engineering.
How we will work together
Through our new translational partnerships we will work closely with partners to explore new ways of supporting transition and to share best practice.
By working at institutional level, we can work with each university to develop support which will best suit its own researchers.
Support through the new partnerships will be primarily, but not exclusively, for Wellcome-supported scientists. It will include a portfolio of activities, for example:
:: developing seed funds, identifying mentors and entrepreneurs in residence
:: access to Wellcome’s network of advisers, experts and mentors
:: introductions to potential partners to take promising advances forward…

::::::
Industry Watch    [to 9 December 2017]
:: Bioethics International Releases the “Good Pharma Scorecard” in BMJ Open, Ranking the Top 20 Largest Pharmaceutical Companies on Clinical Trial Transparency
NEW YORK, Dec. 5, 2017 /PRNewswire/ — Bioethics International announced today the second publication of its Good Pharma Scorecard (“GPS”), an annual index ranking large pharmaceutical companies and new drugs on their clinical trial transparency, in BMJ Open. Bioethics International is a not-for-profit organization dedicated to raising the bar on ethics, trustworthiness, and patient-centricity in pharma.
Two of eleven ranked companies—Johnson & Johnson and Sanofi—achieved the highest overall clinical trial transparency scores, both scoring 100%. AbbVie, Celgene, Merck and Astra Zeneca all scored at or above the industry median.
The 2017 GPS ranking evaluates clinical trial registration, results reporting, clinical study report synopsis sharing, and journal article publication rates for new drugs approved by the Food and Drug Administration (FDA) in 2014 that were sponsored by large drug companies. Bioethics International is the first organization to consistently measure large pharma companies and their FDA-approved drugs on their clinical trial transparency performance. This learning system helps advance high-quality, patient-centric, and ethical healthcare innovation, medical evidence, and drug development…

:: Sanofi ends development of Clostridium difficile vaccine
Paris, France – December 1, 2017 – Following a planned interim analysis, the Independent Data Monitoring Committee (IDMC) for the phase III Cdiffense clinical trial program concluded that the probability that the study will meet its primary objective is low. Based on this, Sanofi has therefore decided to discontinue clinical development of its experimental Clostridium difficile vaccine, to focus on six key vaccine projects currently in development….

:: Boehringer Ingelheim Invests $80 Million to Expand Animal Vaccine Manufacturing Capacity in the U.S.
DULUTH, Ga., Dec. 4, 2017 /PRNewswire/ — Boehringer Ingelheim, a leading provider of animal health products for pets and livestock, today announced investments totaling more than $80 million to expand its existing facilities in Athens, GA and St. Joseph, MO to accommodate increased production of animal vaccines.
Boehringer Ingelheim’s facility in Athens, GA will grow from its current footprint of approximately 350,000 square feet to 400,000 square feet and will nearly double its filling capacity for companion animal and avian vaccine…

Journal Watch

Journal Watch

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

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

Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice From the American College of Physicians and the Centers for Disease Control and Prevention

Annals of Internal Medicine
5 December 2017 Vol: 167, Issue 11
http://annals.org/aim/issue

Clinical Guidelines
Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice From the American College of Physicians and the Centers for Disease Control and Prevention

Free   PDF

What Recent History Has Taught Us About Responding to Emerging Infectious Disease Threats

Annals of Internal Medicine
5 December 2017 Vol: 167, Issue 11
http://annals.org/aim/issue

Special Article
What Recent History Has Taught Us About Responding to Emerging Infectious Disease Threats
Catharine I. Paules, MD; Robert W. Eisinger, PhD; Hilary D. Marston, MD, MPH; Anthony S. Fauci, MD
Abstract
Presidential administrations face any number of unexpected crises during their tenure, and global pandemics are among the most challenging. As of January 2017, one of the authors had served under 5 presidents as the director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. During each administration, the government faced unexpected pandemics, ranging from the HIV/AIDS pandemic, which began during the Reagan administration, to the recent Zika outbreak in the Americas, which started during the Obama administration. These experiences underscored the need to optimize preparation for and response to these threats whenever and wherever they emerge. This article recounts selected outbreaks occurring during this period and highlights lessons that were learned that can be applied to the infectious disease threats that will inevitably be faced in the current presidential administration and beyond.

Cost-effectiveness of Human Papilloma Virus (HPV) vaccination in Nigeria: a decision analysis using pragmatic parameter estimates for cost and programme coverage

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 9 December 2017)

Research article
Cost-effectiveness of Human Papilloma Virus (HPV) vaccination in Nigeria: a decision analysis using pragmatic parameter estimates for cost and programme coverage
Authors: Obinna I. Ekwunife and Stefan K. Lhachimi
Citation: BMC Health Services Research 2017 17:815
Published on: 8 December 2017
Abstract
Background
World Health Organisation recommends routine Human Papilloma Virus (HPV) vaccination for girls when its cost-effectiveness in the country or region has been duly considered. We therefore aimed to evaluate cost-effectiveness of HPV vaccination in Nigeria using pragmatic parameter estimates for cost and programme coverage, i.e. realistically achievable in the studied context.
Methods
A microsimulation frame-work was used. The natural history for cervical cancer disease was remodelled from a previous Nigerian model-based study. Costing was based on health providers’ perspective. Disability adjusted life years attributable to cervical cancer mortality served as benefit estimate. Suitable policy option was obtained by calculating the incremental costs-effectiveness ratio. Probabilistic sensitivity analysis was used to assess parameter uncertainty. One-way sensitivity analysis was used to explore the robustness of the policy recommendation to key parameters alteration. Expected value of perfect information (EVPI) was calculated to determine the expected opportunity cost associated with choosing the optimal scenario or strategy at the maximum cost-effectiveness threshold.
Results
Combination of the current scenario of opportunistic screening and national HPV vaccination programme (CS + NV) was the only cost-effective and robust policy option. However, CS + NV scenario was only cost-effective so far the unit cost of HPV vaccine did not exceed $5. EVPI analysis showed that it may be worthwhile to conduct additional research to inform the decision to adopt CS + NV.
Conclusions
National HPV vaccination combined with opportunist cervical cancer screening is cost-effective in Nigeria. However, adoption of this strategy should depend on its relative efficiency when compared to other competing new vaccines and health interventions.

A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 9 December 2017)

Research article
A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination
As annual influenza vaccination is recommended for all U.S. persons aged 6 months or older, it is unethical to conduct randomized clinical trials to estimate influenza vaccine effectiveness (VE). Observational…
Authors: Meng Shi, Qian An, Kylie E. C. Ainslie, Michael Haber and Walter A. Orenstein
Citation: BMC Infectious Diseases 2017 17:757
Published on: 8 December 2017

Intention to vaccinate universally against varicella, rotavirus gastroenteritis, meningococcal B disease and seasonal influenza among parents in the Netherlands: an internet survey

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 9 December 2017)

Research note
Intention to vaccinate universally against varicella, rotavirus gastroenteritis, meningococcal B disease and seasonal influenza among parents in the Netherlands: an internet survey
For the decision-making process regarding introduction of new vaccines into the National Immunisation Programme (NIP), advance insight into the potential acceptance among the population is relevant. We studied…
Authors: Alies van Lier, José A. Ferreira, Liesbeth Mollema, Elisabeth A. M. Sanders and Hester E. de Melker
Citation: BMC Research Notes 2017 10:672
Published on: 4 December 2017

Advancing the science of health research capacity strengthening in low-income and middle-income countries: a scoping review of the published literature, 2000–2016

BMJ Open
December 2017 – Volume 7 – 12
http://bmjopen.bmj.com/content/current
Global health – Research

Advancing the science of health research capacity strengthening in low-income and middle-income countries: a scoping review of the published literature, 2000–2016
Substantial development assistance and research funding are invested in health research capacity strengthening (HRCS) interventions in low-income and middle-income countries, yet the effectiveness, impact and value for money of these investments are not well understood. A major constraint to evidence-informed HRCS intervention has been the disparate nature of the research effort to date. This review aims to map and critically analyse the existing HRCS effort to better understand the level, type, cohesion and conceptual sophistication of the current evidence base. The overall goal of this article is to advance the development of a unified, implementation-focused HRCS science.
Laura Dean, Stefanie Gregorius, Imelda Bates, Justin Pulford

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

BMJ Open
December 2017 – Volume 7 – 12
http://bmjopen.bmj.com/content/current

Ethics – Research
Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies
Jennifer E Miller, Marc Wilenzick, Nolan Ritcey, Joseph S Ross, Michelle M Mello
Abstract
Objectives To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.
Design Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.
Data sources Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers.
Outcome measures Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level.
Results The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%–100%) of trials in patients were registered, 71% (IQR 57%–100%) reported results or shared a CSR synopsis, 80% (70%–100%) were published and 96% (80%–100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%–100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries.
Conclusions Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies’ transparency records and recognise exemplary companies may encourage further progress.

Polio, terror and the immunological worldview

Global Public Health
Volume 13, 2017   Issue 2
http://www.tandfonline.com/toc/rgph20/current

Article
Polio, terror and the immunological worldview
Robert Peckham
Pages: 189-210
Published online: 22 Jul 2016
ABSTRACT
This paper adopts a socio-historical perspective to explore when, how and why the eradication of poliomyelitis has become politicised to the extent that health workers and security personnel are targeted in drive-by shootings. Discussions of the polio crisis in Afghanistan and Pakistan have tended to focus on Taliban suspicions of a US-led public health intervention and the denunciation of ‘modernity’ by Islamic ‘extremists’. In contrast, this paper considers a broader history of indigenous hostility and resistance to colonial immunisation on the subcontinent, suggesting how interconnected public health and political crises today have reactivated the past and created a continuity between events. The paper explores how the biomedical threat posed by polio has become intertwined with military and governmental discourses premised on the ‘preemptive strike’. Here, the paper tracks the connections between biological immunity and a postcolonial politics that posits an immunological rationale for politico-military interventions. The paper concludes by reflecting on the consequences for global public health of this entanglement of infectious disease with terror.

Editorial—The Critical Role of Research in Advancing Romani’s Right to Health

Health and Human Rights
Volume 19, Issue 2, December 2017
http://www.hhrjournal.org/
Special Section on Romani People and the Right to Health
in collaboration with the FXB Center for Health and Human Rights, Harvard School of Public Health, Boston, USA – [Nine articles]
December 5, 2017

Editorial—The Critical Role of Research in Advancing Romani’s Right to Health
Jacqueline Bhabha, Margareta Matache, and Teresa Sorde Marti
As we finalize this special section on Romani People and the Right to Health, a landmark ruling on Roma health rights has just been handed down by the European Committee of Social Rights. On October 16, 2017, the committee accepted as admissible the European Roma Rights Centre’s complaint against Bulgaria alleging systemic discrimination against Romani women in maternity wards.[1] The complaint details segregation, substandard and abusive maternity care, and disproportionate barriers in access to health insurance for this part of the Roma population.[2] The committee’s finding advances official recognition of the intersectional discrimination affecting Romani women and girls across Europe and perhaps beyond. We use the word “perhaps” advisedly, for conclusive evidence documenting discriminatory and racist practices against Roma living on other continents is lacking, a point underlined in 2016 by Rita Izsak-Ndiaye, the United Nations (UN) Special Rapporteur on minority issues…[3]

Foreword—Harnessing the Power and Promise of Human Rights to End AIDS by 2030

Special Section on HIV and Human Rights 
in collaboration with UNAIDS, the Joint United Nations Programme on HIV/AIDS, Geneva, Switzerland  [Twelve articles]
Posted on December 5, 2017

Foreword—Harnessing the Power and Promise of Human Rights to End AIDS by 2030

Michel Sidibé

The HIV epidemic and response are at a critical juncture. Our advances against the epidemic have been impressive, with unprecedented numbers of people accessing antiretroviral treatment, especially in low- and middle-income countries, and a global reduction in new HIV infections.

However, the epidemic is not over, and the challenges ahead are significant. More than 15.8 million people are still awaiting treatment, while an estimated 11 million people do not know their HIV status. Globally, adolescent girls and young women account for approximately 7,000 new HIV infections every week. These figures represent an indefensible injustice: millions of people worldwide are being denied their right to health.

Common to these challenges are stigma, discrimination, gender inequality, denial of services, violence, and human rights violations against people living with HIV and those most vulnerable to the epidemic, including women, young people, sex workers, prisoners, people who use drugs, transgender persons, and gay men and men who have sex with men.

In all regions, and regardless of the nature and level of the epidemic, vulnerability to HIV is linked to inequality and disenfranchisement; and women and those at the margins of society remain underserved by health services, including HIV prevention, treatment, care, and support services. This special section of Health and Human Rights comes at an opportune moment to describe and reflect on our progress to realize human rights as an imperative for health…

The underlying message in this special section is that we have a moral and legal responsibility to act. We must build on the rights-based lessons of the past and find innovative ways to expand protections, to promote gender equality, to support civil society and community engagement, to strengthen accountability, and to close the inclusion gap between those who have and those who do not. As the UN High Commissioner for Human Rights reminded us at the 2017 Human Rights Council Social Forum: “When human dignity and equality are placed, strongly, at the core of policy, they unlock better outcomes.”

 

 

Humanitarian Exchange Magazine

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

Policies and strategies to facilitate secondary use of research data in the health sciences

International Journal of Epidemiology
Volume 46, Issue 6, 1 December 2017
https://academic.oup.com/ije/issue/46/6

Editorial
Policies and strategies to facilitate secondary use of research data in the health sciences
Paul R Burton; Natalie Banner; Mark J Elliot; Bartha Maria Knoppers; James Banks
International Journal of Epidemiology, Volume 46, Issue 6, 1 December 2017, Pages 1729–1733, https://doi.org/10.1093/ije/dyx195
Abstract
Data are increasingly seen as a fundamental resource that underpins research across biomedicine and the broader health sciences. They often have important value and utility beyond the purpose for which they were originally collected. Recognizing this, many initiatives across the globe actively seek to enable and promote greater sharing of research data, and most major funders now require researchers to set out formal plans for managing and sharing their data with users beyond their own study team. To provide a contextual backdrop to the article and to point the reader to additional sources of relevant information, we include a table listing examples of international, regional and national projects that seek to enhance and facilitate data sharing in a variety of different ways. Table 1 is not intended as an exhaustive catalogue, rather it aims to provide an illustrative listing of a variety of projects we believe to be in good standing around the world, to demonstrate the broad diversity of responses to the important challenges presented by data sharing.

Putting research evidence at the heart of policy making

The Lancet
Dec 09, 2017 Volume 390 Number 10112 p2527-2604  e50
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Putting research evidence at the heart of policy making
The Lancet
To improve patient outcomes, research must inform and shape policy. As history sadly teaches, this ideal is not always realised. But in today’s Lancet, two Articles display how research addressing knowledge gaps can inform policy for hypertension control in China.

Stroke is the leading cause of death in China, driven largely by uncontrolled hypertension. Jiapeng Lu and colleagues estimate that 37·2% of Chinese adults aged 35–75 years have hypertension (defined as a blood pressure in excess of 140/90 mm Hg or a patient receiving antihypertensive medications). Among the population with hypertension, 22·9% take prescribed antihypertensive medicines, but only 5·7% achieve hypertension control. In an accompanying paper, Meng Su and colleagues report huge gaps in the availability and prescription of antihypertensive medications in primary health-care centres (PHC) in China. 8·1% of PHCs stocked no antihypertensive drugs. Low-cost and effective medications recommended in Chinese guidelines were only prescribed in 11·2% of PHCs.

The two studies, funded by China National Development and Reform Commission and National Health and Family Planning Commission (NHFPC), have profound implications for China’s health policy. Using the evidence generated from this work, the NHFPC established the National Primary Healthcare Hypertension Management Office in March, 2017. The office will guide hypertension management, provide training for PHC professionals, collect data, and assess the quality of care in PHCs in terms of hypertension control. In September, 2017, new PHC hypertension control guideline and quality measurement indicators were integrated into the Basic Public Health Service Program. Notably, hypertensive medication availability is now included as one of the indicators to evaluate PHC performance.

China’s story of putting research evidence at the very heart of policy making sets an important example for applying the best solutions to the most burdensome health problems, and fitting those solutions into a health service to bring about system change. The next vital step for China to continue to improve its health outcomes would be through the evaluation of policy change via robust research.

The need for a complex systems model of evidence for public health

The Lancet
Dec 09, 2017 Volume 390 Number 10112 p2527-2604  e50
http://www.thelancet.com/journals/lancet/issue/current

Viewpoint
The need for a complex systems model of evidence for public health
Harry Rutter, Natalie Savona, Ketevan Glonti, Jo Bibby, Steven Cummins, Diane T Finegood, Felix Greaves, Laura Harper, Penelope Hawe, Laurence Moore, Mark Petticrew, Eva Rehfuess, Alan Shiell, James Thomas, Martin White
Summary
Despite major investment in both research and policy, many pressing contemporary public health challenges remain. To date, the evidence underpinning responses to these challenges has largely been generated by tools and methods that were developed to answer questions about the effectiveness of clinical interventions, and as such are grounded in linear models of cause and effect. Identification, implementation, and evaluation of effective responses to major public health challenges require a wider set of approaches1,2 and a focus on complex systems.

Research on HIV cure: Mapping the ethics landscape

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 9 December 2017)

Essay
Research on HIV cure: Mapping the ethics landscape
Karine Dubé, Laurie Sylla, Lynda Dee, Jeff Taylor, David Evans, Carl Dean Bruton, Adam Gilberston, Lisa Gralinski, Brandon Brown, Asheley Skinner, Bryan J. Weiner, Sandra B. Greene, Amy Corneli, Adaora A. Adimora, Joseph D. Tucker, Stuart Rennie
| published 08 Dec 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002470
Summary points
:: According to current estimates, 36.7 million people are infected with HIV worldwide. Despite large-scale and growing programs to prevent and treat HIV infection, possible approaches to achieve a cure for HIV infection are of strong interest.
:: In the development of candidate approaches to achieve an HIV cure, issues of future translation to human study participants, evidence-based practice, clinical care, diverse populations, and populations in low- and middle-income countries should all be considered.
: An HIV cure should be effective, safe, simple, affordable, and scalable.
:: Acceptability research is a critical adjunct to ongoing biomedical HIV cure research efforts.
:: Anticipating some of the ethical and implementation challenges related to HIV cure strategies is necessary before the availability of effective interventions.
:: Ongoing engagement of stakeholders is needed to resolve ethical, logistical, social, cultural, policy, regulatory, and implementation challenges at all stages of the HIV cure research development process.
Conclusion
Tremendous human, financial, and social capital is being invested in the discovery of an HIV cure. For an HIV cure regimen to prove valuable, it should be effective, safe, simple, affordable, and scalable [29]. It should also be translatable to human study participants, evidence-based practice, clinical care, and diverse populations. Appreciating the inherent translational ethics issues across the entire research continuum is essential, as HIV cure discoveries must eventually translate to real-world implementation. In this paper, we reviewed some of the considerations at each step of the HIV cure translation and implementation continuum; the issues described are not comprehensive. We asserted that an ethics of translation should begin early in the HIV cure discovery effort, before the availability of efficacious interventions. Logistical, social, cultural, and economic issues will affect the implementation of HIV cure research and interventions at the individual, institutional, national, and global levels. Ongoing community and stakeholder engagement efforts will be crucial to foresee, negotiate, and resolve potential ethical and implementation challenges. Innovative translational and implementation research paradigms utilized at all phases of the HIV cure research continuum will permit us to address critical issues that will ultimately help leverage cutting-edge HIV cure research discoveries to benefit PLWHIV around the globe.

The importance of thinking beyond the water-supply in cholera epidemics: A historical urban case-study

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 9 December 2017)

Research Article
The importance of thinking beyond the water-supply in cholera epidemics: A historical urban case-study
Matthew D. Phelps, Andrew S. Azman, Joseph A. Lewnard, Marina Antillón, Lone Simonsen, Viggo Andreasen, Peter K. M. Jensen, Virginia E. Pitzer
| published 27 Nov 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006103
Conclusions/Significance
Spatially targeted cholera interventions, such as reactive vaccination or sanitation/hygiene campaigns in hotspot neighborhoods, would likely have been more effective in this epidemic than control measures aimed at interrupting long-cycle transmission, such as improving municipal water quality. We recommend public health planners consider programs aimed at interrupting short-cycle transmission as essential tools in the cholera control arsenal.

A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection

Science Translational Medicine
06 December 2017   Vol 9, Issue 419
http://stm.sciencemag.org/

Report
A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection
By Michael C. Sneller, J. Shawn Justement, Kathleen R. Gittens, Mary E. Petrone, Katherine E. Clarridge, Michael A. Proschan, Richard Kwan, Victoria Shi, Jana Blazkova, Eric W. Refsland, Daryl E. Morris, Kristen W. Cohen, M. Juliana McElrath, Rong Xu, Michael A. Egan, John H. Eldridge, Erika Benko, Colin Kovacs, Susan Moir, Tae-Wook Chun, Anthony S. Fauci
Science Translational Medicine06 Dec 2017 Full Access
Despite lack of vaccine efficacy, the kinetics and magnitude of HIV rebound in early-treated patients affect future clinical trial design.
Editor’s Summary
Single-arm trials can leave you hanging
Depending on the study restraints and goals, not all clinical trials include a randomized placebo group. This is often done to minimize risk to patients but can also impair interpretation of the results. When Sneller et al. embarked on their therapeutic HIV vaccine trial, they chose to include a placebo group to get a better understanding of how their vaccine affected viral rebound upon therapy interruption. The vaccine itself generated minimal T cell activation and did not induce protective responses. Somewhat surprisingly, a proportion of individuals in the placebo arm demonstrated sustained viral suppression, although they were no longer being treated. These results suggest that any future HIV intervention trials would benefit from the inclusion of a placebo arm.
Abstract
Despite substantial clinical benefits, complete eradication of HIV has not been possible using antiretroviral therapy (ART) alone. Strategies that can either eliminate persistent viral reservoirs or boost host immunity to prevent rebound of virus from these reservoirs after discontinuation of ART are needed; one possibility is therapeutic vaccination. We report the results of a randomized, placebo-controlled trial of a therapeutic vaccine regimen in patients in whom ART was initiated during the early stage of HIV infection and whose immune system was anticipated to be relatively intact. The objectives of our study were to determine whether the vaccine was safe and could induce an immune response that would maintain suppression of plasma viremia after discontinuation of ART. Vaccinations were well tolerated with no serious adverse events but produced only modest augmentation of existing HIV-specific CD4+ T cell responses, with little augmentation of CD8+ T cell responses. Compared with placebo, the vaccination regimen had no significant effect on the kinetics or magnitude of viral rebound after interruption of ART and no impact on the size of the HIV reservoir in the CD4+ T cell compartment. Notably, 26% of subjects in the placebo arm exhibited sustained suppression of viremia (<400 copies/ml) after treatment interruption, a rate of spontaneous suppression higher than previously reported. Our findings regarding the degree and kinetics of plasma viral rebound after ART interruption have potentially important implications for the design of future trials testing interventions aimed at achieving ART-free control of HIV infection.

Four years of case-based surveillance of meningitis following the introduction of MenAfriVac in Moissala, Chad: lessons learned (pages 1561–1568)

Tropical Medicine & International Health
December 2017  Volume 22, Issue 12  Pages 1463–1608
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2017.22.issue-11/issuetoc

Original Research Papers
Four years of case-based surveillance of meningitis following the introduction of MenAfriVac in Moissala, Chad: lessons learned (pages 1561–1568)
Anne-Laure Page, Matthew E. Coldiron, Kadidja Gamougam, Mahmaat Ali Acyl, Mbaihol Tamadji, Céline Lastrucci, Northan Hurtado, François-Charles Tehoua, Florence Fermon, Dominique A. Caugant and Klaudia Porten
Version of Record online: 26 OCT 2017 | DOI: 10.1111/tmi.12987
Abstract
Objective
Case-based surveillance of bacterial meningitis in sentinel districts has been recommended after the introduction of the conjugated vaccine against Neisseria meningitidis serogroup A (NmA), MenAfriVac, in the African meningitis belt. Here we report data and lessons learnt from four years of surveillance in the district of Moissala, Chad.
Methods
All suspected cases of meningitis were referred free of charge to the district hospital for lumbar puncture and treatment. Cerebrospinal fluid samples were tested with Pastorex latex agglutination in Moissala, and inoculated trans-isolate media were used for culture and PCR at the national reference laboratory and/or at the Norwegian Institute of Public Health.
Results
From July 2012 to December 2016, 237 suspected cases of meningitis were notified, and a specimen was collected from 224. Eighty-three samples were positive for a bacterial pathogen by culture, PCR or Pastorex, including 58 cases due to Streptococcus pneumoniae with only 28 of 49 pneumococcal meningitis confirmed by culture or PCR correctly identified by Pastorex. Four cases of NmA were detected by Pastorex, but none were confirmed by PCR.
Conclusion
Implementation of case-based surveillance for meningitis is feasible in Chad, but has required political and technical engagement. Given the high proportion of S. pneumoniae and its poor detection by Pastorex, continued use of PCR is warranted for surveillance outside of outbreaks, and efforts to accelerate the introduction of pneumococcal conjugate vaccines are needed. Introduction of MenAfriVac in routine immunisation and future availability of a pentavalent meningococcal conjugate vaccine will be key elements for the sustained reduction in meningitis outbreaks in the area.