International Journal of Community Medicine and Public Health – Vol 4, No 2 (2017) February 2017

International Journal of Community Medicine and Public Health
Vol 4, No 2 (2017) February 2017
http://www.ijcmph.com/index.php/ijcmph/issue/view/10

Original Research Articles
Safety of intradermal rabies vaccine as pre-exposure prophylaxis among veterinary students
Pre-exposure vaccination is a useful tool for protecting high risk groups and purified chick embryo cell rabies vaccine has proved to be safe and well tolerated by intradermal route.
Ravish H. S., Aravind M., Ashwath Narayana D. H., Yannick P., Phaneendra M. S.
DOI: 10.18203/2394-6040.ijcmph20170261

International Journal of Infectious Diseases – Volume 53, Supplement, p1-176 – December 2016

International Journal of Infectious Diseases
Volume 53, Supplement, p1-176 – December 2016
http://www.ijidonline.com/issue/S1201-9712(16)X0011-2
International Meeting on Emerging Diseases and Surveillance (IMED) 2016 Abstracts

Highlights from the 6th International Meeting on Emerging Diseases and Surveillance (IMED 2016) Vienna, Austria from Nov 3 to 7, 2016
Britta Lassmann, Lawrence C. Madoff

Vaccine trials during outbreaks: The Sierra Leone trial to introduce a vaccine against Ebola (STRIVE) experience
B. Mahon
Published in issue: December 2016
Abstract
West Africa’s Ebola epidemic was unprecedented in size and complexity. In September 2014, exponential increase in cases raised concern that timely control might not be achievable without a vaccine, so vaccine development was accelerated. By late 2014, Phase 1 studies of candidate vaccines started, and multiple organizations began planning phase 2/3 studies with collaborators in Ebola-affected countries. The US Centers for Disease Control and Prevention sponsored STRIVE, a phase 2/3 trial in Sierra Leone, in collaboration with the College of Medicine and Allied Health Sciences, University of Sierra Leone, and the Ministry of Health and Sanitation. STRIVE was designed as an individually randomized trial to simultaneously evaluate safety and efficacy of recombinant vesicular stomatitis virus Zaire Ebola vaccine (rVSV-ZEBOV) in healthcare and frontline Ebola response workers; no placebo was used. Participants were randomized to immediate (within 7 days) or delayed (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola infection. Sub-studies collected detailed safety, reactogenicity, and immunogenicity data. STRIVE established 7 enrollment and vaccination sites in 5 districts, 3 data centers, and a -80o C vaccine cold chain. STRIVE staff conducted >100 outreach sessions targeting potential participants, community members, and health leaders and trained >350 Sierra Leone staff. The study design evolved in response to the changing epidemiologic situation. A stepped wedge design (sequential vaccination after full enrollment) was initially considered but was replaced by phased enrollment to allow earlier vaccination in the context of the ongoing outbreak. After another trial demonstrated likely efficacy, some participants in the delayed vaccination group were vaccinated before 18-24 weeks. From April to December 2015, >8,650 participants were enrolled and >8,000 vaccinated. Ebola response measures successfully interrupted transmission, so vaccine efficacy could not be assessed. Preliminary analysis of safety data indicates no vaccine-related deaths or other serious adverse events; these data will be critical to application for licensure. Implementing STRIVE without detracting from the response to an epidemic of a highly lethal virus, in the face of limited infrastructure, high community concern, and changing epidemiology required extensive partnership-building, creativity, collaboration, and flexibility.

Journal of Infectious Diseases – Volume 215, Issue 2 15 January 2017

Journal of Infectious Diseases
Volume 215, Issue 2 15 January 2017
http://jid.oxfordjournals.org/content/current

Editor’s Choice
Boosting Immune Responses Following Fractional-Dose Inactivated Poliovirus Vaccine: A Randomized, Controlled Trial
Sonia Resik; Alina Tejeda; Manuel Diaz; Hiromasa Okayasu; Carolyn Sein …

BACTERIA
Development of a Live Attenuated Bivalent Oral Vaccine Against Shigella sonnei Shigellosis and Typhoid Fever
Yun Wu; Sumana Chakravarty; Minglin Li; Tint T. Wai; Stephen L. Hoffman …

Journal of Patient-Centered Research and Reviews – Volume 4, Issue 1 (2017)

Journal of Patient-Centered Research and Reviews
Volume 4, Issue 1 (2017)
http://digitalrepository.aurorahealthcare.org/jpcrr/

Topic Synopses
A Critical Discussion of Patient Engagement in Research
Andrea Elaine Bombak and Heather M. Hanson
Abstract
Patients are increasingly expected to take a more involved role in research. Funding for some projects now requires incorporating patients’ viewpoints or involvement in research processes. While intended to achieve commendable goals, it is important to critically assess the means used to achieve these aims. Presently, there may be issues of valuing only certain epistemologies, failing to evaluate existing programs and their impacts, marginalizing less “engaged” patients, and promoting only tokenism. These are areas that require exploration and reflection before assuming that patient engagement approaches are sufficient or the only means of incorporating patient perspectives into research.

The Lancet – Feb 04, 2017 Volume 389 Number 10068 p477-572 e2

The Lancet
Feb 04, 2017 Volume 389 Number 10068 p477-572 e2
http://www.thelancet.com/journals/lancet/issue/current

Articles
Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!)
Ana Maria Henao-Restrepo, Anton Camacho, Ira M Longini, Conall H Watson, W John Edmunds, Matthias Egger, Miles W Carroll, Natalie E Dean, Ibrahima Diatta, Moussa Doumbia, Bertrand Draguez, Sophie Duraffour, Godwin Enwere, Rebecca Grais, Stephan Gunther, Pierre-Stéphane Gsell, Stefanie Hossmann, Sara Viksmoen Watle, Mandy Kader Kondé, Sakoba Kéïta, Souleymane Kone, Eewa Kuisma, Myron M Levine, Sema Mandal, Thomas Mauget, Gunnstein Norheim, Ximena Riveros, Aboubacar Soumah, Sven Trelle, Andrea S Vicari, John-Arne Røttingen, Marie-Paule Kieny
Published: 22 December 2016 Open Access

Nature – Volume 542 Number 7639 pp5-132 2 February 2017

Nature
Volume 542 Number 7639 pp5-132 2 February 2017
http://www.nature.com/nature/current_issue.html

Editorials
The time is ripe to reform the World Health Organization
As the public-health agency chooses a new leader, the media and politicians must be more realistic about what it can do.

Comment
Consider drug efficacy before first-in-human trials
Ethical review boards must focus on clinical promise as well as safety to hold the first tests of drugs in humans to a higher standard, say Jonathan Kimmelman and Carole Federico.

Nature Reviews Immunology – February 2017 Vol 17 No 2

Nature Reviews Immunology
February 2017 Vol 17 No 2
http://www.nature.com/nri/journal/v17/n2/index.html

Reviews
Disease tolerance and immunity in host protection against infection
Miguel P. Soares, Luis Teixeira & Luis F. Moita
p83 | doi:10.1038/nri.2016.136
Disease tolerance is a defence strategy that functions by improving tissue repair or by reducing the detrimental effect of inflammatory signals to prevent the harmful effects of pathogens. This Review describes the mechanisms underlying disease tolerance to infections and how these can be targeted therapeutically.

New England Journal of Medicine – February 2, 2017  Vol. 376 No. 5

New England Journal of Medicine
February 2, 2017  Vol. 376 No. 5
http://www.nejm.org/toc/nejm/medical-journal
Review Article
The Changing Face of Clinical Trials
Jeffrey M. Drazen, M.D., David P. Harrington, Ph.D., John J.V. McMurray, M.D., James H. Ware, Ph.D., Janet Woodcock, M.D., Editors
Drug-Development Challenges for Small Biopharmaceutical Companies
Richard A. Moscicki, M.D., and P.K. Tandon, Ph.D.
N Engl J Med 2017; 376:469-474 February 2, 2017 DOI: 10.1056/NEJMra1510070

Pediatrics – February 2017, VOLUME 139 / ISSUE 2

Pediatrics
February 2017, VOLUME 139 / ISSUE 2
http://pediatrics.aappublications.org/content/139/2?current-issue=y
Articles
Effectiveness and Duration of Protection of One Dose of a Meningococcal Conjugate Vaccine
Amanda C. Cohn, Jessica R. MacNeil, Lee H. Harrison, Ruth Lynfield, Arthur Reingold, William Schaffner, Elizabeth R. Zell, Brian Plikaytis, Xin Wang, Nancy E. Messonnier, for the Active Bacterial Core Surveillance (ABCs) Team and MeningNet Surveillance Partners
Pediatrics Feb 2017, 139 (2) e20162193; DOI: 10.1542/peds.2016-2193

PharmacoEconomics – Volume 35, Issue 2, February 2017

PharmacoEconomics
Volume 35, Issue 2, February 2017
http://link.springer.com/journal/40273/35/2/page/1

Systematic Review
Economic Evaluations of Pharmaceuticals Granted a Marketing Authorisation Without the Results of Randomised Trials: A Systematic Review and Taxonomy
Anthony J. Hatswell, Nick Freemantle, Gianluca Baio
Abstract
Background
Pharmaceuticals are usually granted a marketing authorisation on the basis of randomised controlled trials (RCTs). Occasionally the efficacy of a treatment is assessed without a randomised comparator group (either active or placebo).
Objective
To identify and develop a taxonomic account of economic modelling approaches for pharmaceuticals licensed without RCT data.

Methods
We searched PubMed, the websites of UK health technology assessment bodies and the International Society for Pharmacoeconomics and Outcomes Research Scientific Presentations Database for assessments of treatments granted a marketing authorisation by the US Food and Drug Administration or European Medicines Agency from January 1999 to May 2014 without RCT data (74 indications). The outcome of interest was the approach to modelling efficacy data.

Results
Fifty-one unique models were identified in 29 peer-reviewed articles, 30 health technology appraisals, and 15 International Society for Pharmacoeconomics and Outcomes Research abstracts concerning 30 indications (44 indications had not been modelled). We noted the high rate of non-submission to health technology assessment agencies (28/98). The majority of models (43/51) were based on ‘historical controls’—comparisons to previous meta-analysis or pooling of trials (5), individual trials (16), registries/case series (15), or expert opinion (7). Other approaches used the patient as their own control, performed threshold analysis, assumed time on treatment was added to overall survival, or performed cost-minimisation analysis.

Conclusions
There is considerable variation in the quality and approach of models constructed for drugs granted a marketing authorisation without a RCT. The most common approach is of a naive comparison to historical data (using other trials/registry data as a control group), which has considerable scope for bias.

PLoS Currents: Outbreaks

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 4 February 2017]

Research Article
Aedes aegypti Control Through Modernized, Integrated Vector Management
January 30, 2017 ·
Introduction: In the context of the ongoing, unprecedented Zika virus outbreak in the Americas, the World Health Organization has expressed its support for developing and up-scaling three novel approaches to controlling the Aedes aegypti mosquito: the Sterile Insect Technique (SIT), the Release of Insects carrying Dominant Lethal genes (RIDL) and the release of Wolbachia-infected mosquitoes. Whereas the former two approaches are temporary insect population suppression strategies, Wolbachia infection is a self-sustaining, invasive strategy that uses inherited endosymbiotic bacteria to render natural mosquito populations arbovirus resistant.

Methods: A mathematical model is parameterised with new, Brazilian field data informing the mating competitiveness of mass-reared, released insects; and simulations compare and contrast projections of vector control achieved with the alternative approaches.

Results: Important disadvantages of Wolbachia and SIT are identified: both strategies result in mosquitoes ovipositing non-viable eggs and, by alleviating intense larval competition, can cause an overall increase in survival to the adult stage. However, it is demonstrated that strategically combining the suppression methods with Wolbachia can generate a sustained control while mitigating the risks of inadvertent exacerbation of the wild mosquito population.

Discussion: This initial analysis demonstrates potential for good synergy when combining novel mosquito approaches in a modernized, integrated vector control programme.

PLoS One

PLoS One
http://www.plosone.org/
[Accessed 4 February 2017]

Research Article
What is the economic evidence for mHealth? A systematic review of economic evaluations of mHealth solutions
Sarah J. Iribarren, Kenrick Cato, Louise Falzon, Patricia W. Stone
Research Article | published 02 Feb 2017 PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0170581

Abstract
Background
Mobile health (mHealth) is often reputed to be cost-effective or cost-saving. Despite optimism, the strength of the evidence supporting this assertion has been limited. In this systematic review the body of evidence related to economic evaluations of mHealth interventions is assessed and summarized.

Methods
Seven electronic bibliographic databases, grey literature, and relevant references were searched. Eligibility criteria included original articles, comparison of costs and consequences of interventions (one categorized as a primary mHealth intervention or mHealth intervention as a component of other interventions), health and economic outcomes and published in English. Full economic evaluations were appraised using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist and The PRISMA guidelines were followed.

Results
Searches identified 5902 results, of which 318 were examined at full text, and 39 were included in this review. The 39 studies spanned 19 countries, most of which were conducted in upper and upper-middle income countries (34, 87.2%). Primary mHealth interventions (35, 89.7%), behavior change communication type interventions (e.g., improve attendance rates, medication adherence) (27, 69.2%), and short messaging system (SMS) as the mHealth function (e.g., used to send reminders, information, provide support, conduct surveys or collect data) (22, 56.4%) were most frequent; the most frequent disease or condition focuses were outpatient clinic attendance, cardiovascular disease, and diabetes. The average percent of CHEERS checklist items reported was 79.6% (range 47.62–100, STD 14.18) and the top quartile reported 91.3–100%. In 29 studies (74.3%), researchers reported that the mHealth intervention was cost-effective, economically beneficial, or cost saving at base case.

Conclusions
Findings highlight a growing body of economic evidence for mHealth interventions. Although all studies included a comparison of intervention effectiveness of a health-related outcome and reported economic data, many did not report all recommended economic outcome items and were lacking in comprehensive analysis. The identified economic evaluations varied by disease or condition focus, economic outcome measurements, perspectives, and were distributed unevenly geographically, limiting formal meta-analysis. Further research is needed in low and low-middle income countries and to understand the impact of different mHealth types. Following established economic reporting guidelines will improve this body of research.

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

PNAS – Proceedings of the National Academy of Sciences of the United States
of America
http://www.pnas.org/content/early/

Biological Sciences – Applied Biological Sciences – Social Sciences – Economic Sciences: Estimating the population-level impact of vaccines using synthetic controls
Christian A. W. Bruhn, Stephen Hetterich, Cynthia Schuck-Paim, Esra Kürüm, Robert J. Taylor,
Roger Lustig, Eugene D. Shapiro, Joshua L. Warren, Lone Simonsen, and Daniel M. Weinberger
PNAS 2017 ; published ahead of print February 1, 2017, doi:10.1073/pnas.1612833114

Significance
Pneumococcus, a bacterial pathogen, is among the most important causes of pneumonia globally. Quantifying the impact of pneumococcal conjugate vaccines (PCVs) on pneumonia is challenging due to time trends unrelated to the vaccine. We use a method developed for website analytics and economics called “synthetic controls” to disentangle changes in pneumonia rates caused by the vaccine from changes caused by unrelated factors. We found that PCVs significantly reduce all-cause pneumonia hospitalizations in young children, and reduce hospitalizations for invasive pneumococcal disease and pneumococcal pneumonia in children and adults. In contrast to previous studies, we did not detect a decline in all-cause pneumonia hospitalizations in older adults in any of the five countries following the introduction of the vaccine in children.

Abstract
When a new vaccine is introduced, it is critical to monitor trends in disease rates to ensure that the vaccine is effective and to quantify its impact. However, estimates from observational studies can be confounded by unrelated changes in healthcare utilization, changes in the underlying health of the population, or changes in reporting. Other diseases are often used to detect and adjust for these changes, but choosing an appropriate control disease a priori is a major challenge. The “synthetic controls” (causal impact) method, which was originally developed for website analytics and social sciences, provides an appealing solution. With this approach, potential comparison time series are combined into a composite and are used to generate a counterfactual estimate, which can be compared with the time series of interest after the intervention. We sought to estimate changes in hospitalizations for all-cause pneumonia associated with the introduction of pneumococcal conjugate vaccines (PCVs) in five countries in the Americas. Using synthetic controls, we found a substantial decline in hospitalizations for all-cause pneumonia in infants in all five countries (average of 20%), whereas estimates for young and middle-aged adults varied by country and were potentially influenced by the 2009 influenza pandemic. In contrast to previous reports, we did not detect a decline in all-cause pneumonia in older adults in any country. Synthetic controls promise to increase the accuracy of studies of vaccine impact and to increase comparability of results between populations compared with alternative approaches.

Prehospital & Disaster Medicine – Volume 32 – Issue 1 – February 2017

Prehospital & Disaster Medicine
Volume 32 – Issue 1 – February 2017
https://www.cambridge.org/core/journals/prehospital-and-disaster-medicine/latest-issue

Comprehensive Reviews
Health Service Impact from Mass Gatherings: A Systematic Literature Review
Published online: 12 December 2016, pp. 71-77
Jamie Ranse, Alison Hutton, Toby Keene, Shane Lenson, Matt Luther, Nerolie Bost, Amy N. B. Johnston, Julia Crilly, Matt Cannon, Nicole Jones, Courtney Hayes, Brandon Burke
DOI: https://doi.org/10.1017/S1049023X16001199

Abstract
During a mass gathering, some participants may receive health care for injuries or illnesses that occur during the event. In-event first responders provide initial assessment and management at the event. However, when further definitive care is required, municipal ambulance services provide additional assessment, treatment, and transport of participants to acute care settings, such as hospitals. The impact on both ambulance services and hospitals from mass-gathering events is the focus of this literature review.

This literature review aimed to develop an understanding of the impact of mass gatherings on local health services, specifically pertaining to in-event and external health services.
This research used a systematic literature review methodology. Electronic databases were searched to find articles related to the aim of the review. Articles focused on mass-gathering health, provision of in-event health services, ambulance service transportation, and hospital utilization.

Twenty-four studies were identified for inclusion in this review. These studies were all case-study-based and retrospective in design. The majority of studies (n=23) provided details of in-event first responder services. There was variation noted in reporting of the number and type of in-event health professional services at mass gatherings. All articles reported that patients were transported to hospital by the ambulance service. Only nine articles reported on patients presenting to hospital. However, details pertaining to the impact on ambulance and hospital services were not reported.

There is minimal research focusing on the impact of mass gatherings on in-event and external health services, such as ambulance services and hospitals. A recommendation for future mass-gathering research and evaluation is to link patient-level data from in-event mass gatherings to external health services. This type of study design would provide information regarding the impact on health services from a mass gathering to more accurately inform future health planning for mass gatherings across the health care continuum.

Preventive Medicine – Volume 95, Pages 1-118 (February 2017)

Preventive Medicine
Volume 95, Pages 1-118 (February 2017)
http://www.sciencedirect.com/science/journal/00917435/95

Review Articles
Factors associated with parents’ attitudes to the HPV vaccination of their adolescent sons : A systematic review
Gorjana Radisic, Janine Chapman, Ingrid Flight, Carlene Wilson
Abstract
Objective
The objective of the study was to identify factors associated with human papilloma virus (HPV) vaccine acceptability in parents of adolescent boys. This information is critical to the development of approaches to optimise HPV vaccine uptake among this population group.

Methods
We performed a systematic search of the literature in addressing factors influencing parental attitudes to and beliefs about HPV vaccine and its acceptability for use. The findings were organised within the framework of the Health Belief Model (HBM) and summarised using a semi quantitative method.

Results
Eighteen studies met the inclusion criteria. Parental decisions were predominantly shaped by the perceived benefits of the vaccine; perceived risk of sons contracting the HPV infection, and having recommendations from health care providers. Fear of side effects and uncertainty about vaccine effectiveness, as well as cost and lack of healthcare, were barriers to HPV vaccination. Other factors such as knowledge, family characteristics, parent–child dialogue and egalitarian values appeared to be important when deciding whether to vaccinate boys.

Conclusions
HPV vaccine uptake among male adolescents is suboptimal. Future programs need to address the predictors of uptake by educating parents about the boys’ high susceptibility to infection, the benefits of vaccination, and reduce concerns regarding perceived barriers. Additionally, uptake may be facilitated by encouraging health care provider endorsement, particularly in countries without government-funded immunisation programs.

Science – 03 February 2017 Vol 355, Issue 6324

Science
03 February 2017 Vol 355, Issue 6324
http://www.sciencemag.org/current.dtl
Special Issue: Prediction

Introduction to special issue
Prediction and its limits
By Barbara R. Jasny, Richard Stone
Science03 Feb 2017 : 468-469
We have tried to predict the future since ancient times when shamans looked for patterns in smoking entrails. As this special section explores, prediction is now a developing science. Essays probe such questions as how to allocate limited resources, whether a country will descend into conflict, and who will likely win an election or publish a high-impact paper, as well as looking at how standards should develop in this emerging field.

Social scientists and the machine learning community are acquiring new analytical tools to distinguish meaningful patterns from noise. New tools are exciting. But using software packages of the shelf, without understanding them fully, can lead to disaster. Several authors in this special section describe the importance of realistic goals that seek to balance machine learning approaches with the human element.

In the 1950s, author Isaac Asimov imagined the science of psychohistory, in which computers crunching gargantuan data sets could forecast the rise and fall of empires. The science is not fully there yet—as the latest U.S. presidential election showed. A News story and associated Report describe the state of the art, with scientists believing that as methods improve and validated data sources grow, elections and other social events will become increasingly predictable.

Success seems to be achieved most consistently when questions are tackled in multidisciplinary efforts that join human understanding of context with algorithmic capacity to handle terabytes of data. Researchers may still fall far short of predicting outcomes with the precision that policy-makers long for, but the scenarios that they now can envision should help shape a better future.

Science – 03 February 2017 Vol 355, Issue 6324

Science
03 February 2017 Vol 355, Issue 6324
http://www.sciencemag.org/current.dtl
Special Issue: Prediction

Editorial
Informing policy with science
By Barbara Schaal
Science03 Feb 2017 : 435
Summary
We recently witnessed the peaceful—if controversial—transition of the United States presidency. As with any major change in federal government, the scientific community has concerns about new directions and priorities that may affect the way science is conducted, funded, and used in the United States and elsewhere. Of particular note with this new administration are concerns that President Trump may not fully value science-based evidence, and that information and policy decisions will be made without due consideration of scientific evidence.

Vaccine – Volume 35, Issue 6, Pages 851-992 (7 February 2017)

Vaccine
Volume 35, Issue 6, Pages 851-992 (7 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/6

Reviews
Influenza in the Asia-Pacific region: Findings and recommendations from the Global Influenza Initiative
Review Article
Pages 856-864
Benjamin J. Cowling, Saverio Caini, Tawee Chotpitayasunondh, Samsuridjal Djauzi, Salvacion R. Gatchalian, Q. Sue Huang, Parvaiz A. Koul, Ping-Ing Lee, Abdul Razak Muttalif, Stanley Plotkin, on behalf of the Global Influenza Initiative
Abstract
The fourth roundtable meeting of the Global Influenza Initiative (GII) was held in Hong Kong, China, in July 2015. An objective of this meeting was to gain a broader understanding of the epidemiology, surveillance, vaccination policies and programs, and obstacles to vaccination of influenza in the Asia-Pacific region through presentations of data from Australia, Hong Kong, India, Indonesia, Malaysia, New Zealand, the Philippines, Taiwan, Thailand, and Vietnam.

As well as a need for improved levels of surveillance in some areas, a range of factors were identified that act as barriers to vaccination in some countries, including differences in climate and geography, logistical challenges, funding, lack of vaccine awareness and education, safety concerns, perceived lack of vaccine effectiveness, and lack of inclusion in national guidelines.

From the presentations at the meeting, the GII discussed a number of recommendations for easing the burden of influenza and overcoming the current challenges in the Asia-Pacific region. These recommendations encompass the need to improve surveillance and availability of epidemiological data; the development and publication of national guidelines, where not currently available and/or that are in line with those proposed by the World Health Organization; the requirement for optimal timing of vaccination programs according to local or country-specific epidemiology; and calls for advocacy and government support of vaccination programs in order to improve availability and uptake and coverage.

In conclusion, in addition to the varied epidemiology of seasonal influenza across this diverse region, there are a number of logistical and resourcing issues that present a challenge to the development of optimally effective vaccination strategies and that need to be overcome to improve access to and uptake of seasonal influenza vaccines. The GII has developed a number of recommendations to address these challenges and improve the control of influenza.

Vaccine – Volume 35, Issue 6, Pages 851-992 (7 February 2017)

Vaccine
Volume 35, Issue 6, Pages 851-992 (7 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/6

Regular Papers
Human papillomavirus vaccine series completion in boys before and after recommendation for routine immunization
Original Research Article
Pages 897-902
Bradley Ackerson, Rulin Hechter, Margo Sidell, Lina S. Sy, Jeffrey Slezak, Chun Chao, Nilesh Patel, Hung-Fu Tseng, Steven Jacobsen

Abstract
Background
Although the incidence of HPV-attributable cancers in males is rapidly increasing, HPV vaccine uptake in males remains poor. While quadrivalent human papillomavirus vaccine (4vHPV) series initiation in males increased following the Advisory Committee Immunization Practices (ACIP) male routine use recommendation, its impact on 4vHPV series completion in males at ACIP-recommended intervals has not been evaluated in large male cohorts. We examined trends and correlates of 4vHPV completion since licensure in males in a large cohort of insured boys before and after the ACIP routine use recommendation.

Methods
We grouped data from electronic medical records of males aged 9–17 years from Kaiser Permanente Southern California health plan who initiated 4vHPV into 3 cohorts by 4vHPV initiation date: licensure and ACIP permissive use: 2009–2010; addition of anal cancer indication: 2010–2011; ACIP routine use: 2011–2013. We estimated adjusted hazard ratios (AHRs) between patient and provider characteristics and vaccination using Marginal Cox proportional hazards models.

Results
Of 80,800 boys initiating 4vHPV, 24.3% completed the series within 12 months with minimal differences across cohorts. Completion decreased with increasing age at initiation (13–17 vs. 11–12 year olds: AHR = 0.85; 95% confidence interval [CI]=0.80, 0.89) and was greater among patients with a primary care provider (AHR=1.28, 95% CI=1.17, 1.41), influenza vaccine recipients (AHR=1.50, 95% CI=1.43, 1.57), and Asian/Pacific Islanders (AHR=1.07, 95% CI=1.00, 1.15), and lower among non-Hispanic Blacks (AHR=0.72, 95% CI=0.65, 0.80) and Hispanics (AHR=0.86, 95% CI=0.81, 0.90) compared to non-Hispanic Whites.

Conclusions
Despite the ACIP routine use recommendation in males, 4vHPV series completion remained low. 4vHPV initiation at 11–12 years and identification of a provider responsible for the adolescents’ health care may increase 4vHPV series completion. Given the rapidly increasing incidence of HPV-related cancers in males, it is important to identify measures to increase HPV vaccine series completion, particularly among non-Hispanic Black and Hispanic males.

Vaccine – Volume 35, Issue 6, Pages 851-992 (7 February 2017)

Vaccine
Volume 35, Issue 6, Pages 851-992 (7 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/6

Monitoring equity in vaccination coverage: A systematic analysis of demographic and health surveys from 45 Gavi-supported countries
Original Research Article
Pages 951-959
Catherine Arsenault, Sam Harper, Arijit Nandi, José M. Mendoza Rodríguez, Peter M. Hansen, Mira Johri

Abstract
Objectives
(1) To conduct a systematic analysis of inequalities in childhood vaccination coverage in Gavi-supported countries; (2) to comparatively assess alternative measurement approaches and how they may affect cross-country comparisons of the level of inequalities.

Methods
Using the most recent Demographic and Health Surveys (2005–2014) in 45 Gavi-supported countries, we measured inequalities in vaccination coverage across seven dimensions of social stratification and of vulnerability to poor health outcomes. We quantified inequalities using pairwise comparisons (risk differences and ratios) and whole spectrum measures (slope and relative indices of inequality). To contrast measurement approaches, we pooled the estimates using random-effects meta-analyses, ranked countries by the magnitude of inequality and compared agreement in country ranks.

Results
At the aggregate level, maternal education, multidimensional poverty, and wealth index poverty were the dimensions associated with the largest inequalities. In 36 out of 45 countries, inequalities were substantial, with a difference in coverage of 10 percentage points or more between the top and bottom of at least one of these social dimensions. Important inequalities by child sex, child malnutrition and urban/rural residence were also found in a smaller set of countries. The magnitude of inequality and ranking of countries differed across dimension and depending on the measure used. Pairwise comparisons could not be estimated in certain countries. The slope and relative indices of inequality were estimated in all countries and produced more stable country rankings, and should thus facilitate more reliable international comparisons.

Conclusions
Inequalities in vaccination coverage persist in a large majority of Gavi-supported countries. Inequalities should be monitored across multiple dimensions of vulnerability. Using whole spectrum measures to quantify inequality across multiple ordered social groups has important advantages. We illustrate these findings using an equity dashboard designed to support decision-making in the Sustainable Development Goals period.

Vaccines — Open Access Journal

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 4 February 2017)

Review
Human T Cell Memory: A Dynamic View
by Derek C. Macallan, José A. M. Borghans and Becca Asquith
Vaccines 2017, 5(1), 5; doi:10.3390/vaccines5010005 (registering DOI) – 4 February 2017
Abstract
Long-term T cell-mediated protection depends upon the formation of a pool of memory cells to protect against future pathogen challenge. In this review we argue that looking at T cell memory from a dynamic viewpoint can help in understanding how memory populations are maintained following pathogen exposure or vaccination. For example, a dynamic view resolves the apparent paradox between the relatively short lifespans of individual memory cells and very long-lived immunological memory by focussing on the persistence of clonal populations, rather than individual cells. Clonal survival is achieved by balancing proliferation, death and differentiation rates within and between identifiable phenotypic pools; such pools correspond broadly to sequential stages in the linear differentiation pathway. Each pool has its own characteristic kinetics, but only when considered as a population; single cells exhibit considerable heterogeneity. In humans, we tend to concentrate on circulating cells, but memory T cells in non-lymphoid tissues and bone marrow are increasingly recognised as critical for immune defence; their kinetics, however, remain largely unexplored. Considering vaccination from this viewpoint shifts the focus from the size of the primary response to the survival of the clone and enables identification of critical system pinch-points and opportunities to improve vaccine efficacy.

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

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

Immunological Reviews
First published: 30 January 2017
INVITED REVIEW
Complex immune correlates of protection in HIV‐1 vaccine efficacy trials
GD Tomaras, SA Plotkin
Summary
Development of an efficacious HIV-1 vaccine is a major priority for improving human health worldwide. Vaccine-mediated protection against human pathogens can be achieved through elicitation of protective innate, humoral, and cellular responses. Identification of specific immune responses responsible for pathogen protection enables vaccine development and provides insights into host defenses against pathogens and the immunological mechanisms that most effectively fight infection. Defining immunological correlates of transmission risk in preclinical and clinical HIV-1 vaccine trials has moved the HIV-1 vaccine development field forward and directed new candidate vaccine development. Immune correlate studies are providing novel hypotheses about immunological mechanisms that may be responsible for preventing HIV-1 acquisition. Recent results from HIV-1 immune correlates work has demonstrated that there are multiple types of immune responses that together, comprise an immune correlate—thus implicating polyfunctional immune control of HIV-1 transmission. An in depth understanding of these complex immunological mechanisms of protection against HIV-1 will accelerate the development of an efficacious HIV-1 vaccine.

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 Daily Beast
http://www.thedailybeast.com/
Accessed 4 February 2017

Are Kids Getting Too Many Vaccines?
Political leaders and parents have expressed concerns that young children are getting too many vaccines, often for diseases that aren’t raging anymore.
Paul A. Offit 29 January 2017
….And while it is difficult to watch children receive so many injections, most parents would probably be surprised to learn that the immunological challenges from today’s 14 vaccines are less than the challenge from that one (i.e. smallpox) vaccine given a hundred years ago….
…Despite claims by Carson, Christie, and Paul, every one of these vaccine-preventable diseases can cause permanent harm or death. So, choosing one vaccine over another wouldn’t be a reasonable choice; it would be an untenable choice—a Sophie’s Choice.

Forbes
http://www.forbes.com/
Accessed 4 February 2017

Museum At Birthplace Of Vaccination Needs Booster Dose of Funds to Stay Open
Tara Haelle, Contributor
31 January 2017
…Starting in 1968, visitors to Gloucestershire could visit the Edward Jenner Museum, located in the cottage Jenner gave James Phipps in gratitude for his involvement. In the same year smallpox was eradicated, in 1980, The Jenner Trust acquired Jenner’s home as well, the Chantry, where Jenner wrote his famous paper. It sits next to the 13th century church of St. Mary’s where Jenner is buried. Since then, the museum at the Chantry has remained open to public visitors who wanted to learn about how Jenner lived, the items he used and the history of smallpox. Until they visit, most people don’t know Jenner was appointed a Fellow of the Royal Society—one of the oldest, most prestigious scientific societies in the world—for his research into birds, not vaccination. It was Jenner who discovered that cuckoos use other birds’ nests to raise their young. Most probably don’t know he discovered dinosaur fossils and launched a hydrogen balloon two years before his experiment with Phipps.

However, the museum’s continuation is in jeopardy. According to the trustees, the budget for Dr. Jenner’s House, Museum and Garden was cut by 55% over the past three years and still operates at a deficit. The United Kingdom has strict requirements for maintaining historical buildings, and the Jenner Trust’s funds have been gradually dwindling. Their income comes primarily from admission charges, events, the museum shop, a schools’ educational program and conference facilities, plus grants and donations…

Trump, Vaccines, And Science Under Threat
Geoffrey Kabat,  Contributor
30 January 2017
…So far, the scientific issue that has gotten the most attention from Trump is that of the safety of vaccines. During the Republican primary campaign, he expressed concerns that vaccines were linked to what he called the autism “epidemic.” A year earlier he had accused the medical community of lying about vaccine safety. Trump, an avid consumer of cable news and social media, has no trouble ignoring the existence of a compelling body of evidence supporting the safety and effectiveness of vaccines in preventing common childhood diseases. This knowledge stems from studies involving hundreds of thousands of children that show no link between vaccines and autism…

The Guardian
http://www.guardiannews.com/
Accessed 4 February 2017

Brazil on high alert as yellow fever threatens major cities
Health ministry ramps up vaccination campaign but cautions against ‘disinformation’, as disease spreads to areas where it is not normally found
Thursday 2 February 2017 Jonathan Watts in Rio de Janeiro

Brazil has ramped up an emergency yellow fever vaccination campaign as the worst outbreak in decades spreads towards major population centres, killing dozens of people and decimating wild monkey populations.

The uptick comes exactly a year after the Zika virus – another mosquito-borne disease – was declared a global health emergency, and as during the previous epidemic Brazilian authorities are struggling to calibrate an appropriate response.

Because there is a vaccine, yellow fever should, in theory, not cause as much of a panic but global vaccine stocks are dwindling, and the disease is far more deadly than Zika.
Of the 107 confirmed cases in the state of Minas Gerais, 40 ended in death. Three patients have also died in São Paulo state and one in Espírito Santo…

New York Times
http://www.nytimes.com/
Accessed 4 February 2017

H. Boyd Woodruff, Microbiologist Who Paved Way for Antibiotics, Dies at 99
February 03, 2017 – By SAM ROBERTS

H. Boyd Woodruff, a farmer’s son whose groundbreaking research enabled fellow scientists to harvest an arsenal of lifesaving antibiotics from ordinary dirt, died on Jan. 19 at his home in Watchung, N.J. He was 99…
His death was confirmed by his son Hugh.

Dr. Woodruff was instrumental in isolating two microbes that, while effective against tuberculosis and other infections, proved toxic to humans. But his findings in the early 1940s inspired the rapid development of streptomycin, the miracle cure used to treat tuberculosis, typhoid, plague and other diseases that did not respond to penicillin and other drugs.
“This was the eureka moment in all antibiotic discovery,” Dr. Douglas E. Eveleigh, a professor emeritus of biochemistry and microbiology at Rutgers University, said of Dr. Woodruff’s research in an email on Thursday.

“The pharmaceutical industry caught on very rapidly, and there followed an avalanche of antibiotics,” Dr. Eveleigh said. “This was all dependent on the Woodruff proof of concept in screening for antibiotic production.”

In 1942, Dr. Woodruff left his laboratory at Rutgers to join Merck & Company, the pharmaceutical giant, where he oversaw the introduction of other antibiotics, vitamins B12 and C, and riboflavin; a treatment for a rare cancer called Wilms tumor; a pneumonia vaccine; and a drug used to treat river blindness

Washington Post
http://www.washingtonpost.com/
Accessed 4 February 2017

Trump’s vaccine views are at odds with those of most Americans, study says
Despite debate about vaccine safety, 82 percent of Americans support the measles, mumps, rubella vaccine for public school children.
Lena H. Sun | National/health-science | Feb 2, 2017

Vaccines and Global Health: The Week in Review 28 January 2017

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

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

 pdf version A pdf of the current issue is available here: vaccines-and-global-health_the-week-in-review_28-january-2017-docx

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

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

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

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

Milestones :: Perspectives

Milestones :: Perspectives

WHO Executive Board announces the names of the 3 nominees for the post of WHO Director-General
25 January 2017
The WHO Executive Board selected by vote the following 3 candidates to be presented to World Health Assembly as nominees for the post of Director-General of WHO.
Five candidates were interviewed by Member States today prior to the vote. The names of the 3 nominees were announced at a public meeting on Wednesday evening, 25 January 2017.
:: Dr Tedros Adhanom Ghebreyesus
:: Dr David Nabarro
:: Dr Sania Nishtar
All Member States will choose among the 3 nominees by vote at the World Health Assembly in May 2017. The new Director-General will take office on 1 July 2017.

::::::

140th session of the Executive Board
23 January–1 February 2017, Geneva
FOLLOW LIVE: Executive Board
The Executive Board will open at 09:30 on Monday 23 January 2017 and can be watched live via webcast. The discussions will be translated into the six UN official languages: Arabic, Chinese, English, French, Russian and Spanish.

During the meeting, WHO’s Executive Board will draw up a short list of 5 candidates on Tuesday 24 January. The following day the Executive Board members will then interview the five candidates and up to three of them to go forward to the World Health Assembly in May 2017.
Live web stream (begins 09:30 CET on Monday 23 January 2017)
Provisional agenda
Main Documents

::::::

Global vaccine action plan
EB140/25
27 Jan 2017 – Webcast of Exec Board discussion
[Video: 1:15] http://www.who.int/mediacentre/events/2017/webstreaming/eb140/en/

Draft resolution proposed by Australia, Brazil and Colombia
Strengthening immunization to achieve the goals of the global vaccine action plan
EB140/CONF./2
[Not adopted; intersessional work to be undertaken to address proposed amendments]

Referenced Supporting Documents
SAGE assessment report 2016
WHO 2016 :: 26 pages
PDF [EN]: http://www.who.int/entity/immunization/global_vaccine_action_plan/SAGE_GVAP_Assessment_Report_2016_EN.pdf?ua=1
EXECUTIVE SUMMARY
At the midpoint of the Global Vaccine Action Plan, or GVAP (2012- 2020), the Strategic Advisory Group of Experts on Immunization (SAGE) remains gravely concerned that progress toward the goals to eradicate polio, eliminate measles and rubella, eliminate maternal and neonatal tetanus, and increase equitable access to lifesaving vaccines is too slow. Despite improvements in individual countries and a strong global rate of new vaccine introduction, global average immunization coverage has increased by only 1% since 2010.

In 2015, 68 countries fell short of the target to achieve at least 90% national coverage with the third dose of diphtheria-tetanus-pertussis vaccine. Not only that, 26 countries reported no change in coverage levels and 25 countries reported a net decrease in coverage since 2010. The 16 countries that have made measurable progress since 2010 are to be commended for reaching more people, especially vulnerable and marginalized members of society with immunization. Some of the countries with the highest numbers of unvaccinated people have made the most progress, including the Democratic Republic of the Congo, Ethiopia and India, and even though coverage targets have not been achieved in these countries, they are moving forward in the right direction.

The 111 countries that entered the decade with high immunization coverage and sustained it through 2015 are already setting their sights on more aggressive goals, additional vaccines, and more equitable coverage. Immunization programmes in these countries can lead the way by increasing access to other public health interventions and providing a platform for the delivery of preventive health services throughout the life course. Vaccine research and development is progressing rapidly, and an expanding pipeline of new vaccines underscores the need to build health systems that can reliably reach new target age groups.

The members of the SAGE are steadfast and passionate believers in the power of immunization to give individuals and their families a better start in life and to protect people from a growing array of debilitating illnesses. Immunization is one of the world’s most effective and cost-effective tools against the threat of emerging diseases and has a powerful impact on social and economic development. Recognizing the role that immunization plays in ensuring good health and the role that good health plays in achieving sustainable development, the SAGE has supported the inclusion of immunization indicators to measure progress toward the Sustainable Development Goals.

The next four years present unprecedented opportunities for countries to leverage the attention and support that immunization receives and apply it for the benefit of people everywhere. Strident efforts on the part of all countries and immunization stakeholders are required to catch up and achieve GVAP goals by 2020.

The SAGE has made nine recommendations which are detailed at the end of this report:
:: Demonstrate stronger leadership and governance of national immunization systems
:: Prioritize immunization system strengthening
:: Secure necessary investments to sustain immunization during polio and Gavi transitions
:: Improve surveillance capacity and data quality and use
:: Enhance accountability mechanisms to monitor implementation of Global and Regional Vaccine Action Plans
:: Achieve elimination targets for maternal and neonatal tetanus, measles, rubella and congenital rubella syndrome
:: Resolve barriers to timely supply of affordable vaccines in humanitarian crisis situations
:: Support vaccine R&D capacity in low- and middle-income countries
:: Accelerate the development and introduction of new vaccines and technologies

GVAP – Monitoring, Evaluation & Accountability – Secretariat report 2016
WHO, 2016 :: 288 pages
Table of Contents
I. Monitoring results: goals, strategic objectives and indicators
1. DISEASE ELIMINATION
2. IMMUNIZATION COVERAGE
3. MILLENNIUM DEVELOPMENT GOAL 4 AND INTEGRATION
4. COUNTRY OWNERSHIP
5. VACCINE HESITANCY
6. SURVEILLANCE
7. VACCINES STOCKOUTS AND USE OF VACCINES IN A CONTROLLED-TEMPERATURE CHAIN
8. SUSTAINABLE FINANCING AND SUPPLY FOR IMMUNIZATION
9. VACCINE SAFETY
10. RESEARCH AND DEVELOPMENT

Emergencies

Emergencies

WHO Grade 3 Emergencies [to 28 January 2017]
Iraq
:: Efforts ongoing to provide trauma care to people in need in Mosul, Iraq
Cairo, 25 January 2017 – As the conflict in Mosul intensifies and greater numbers of civilians are caught in the crossfire, WHO and partners have increased trauma care services to ensure that patients requiring medical care for injuries have a greater chance of survival. However, additional funds are needed in order to provide a full scale of health services to the 2.7 million people affected.

South Sudan
:: WHO and partners scaling up measles vaccination to reach 2.3 million children in South Sudan
18 January 2017, Juba, South Sudan – WHO South Sudan in partnership with the MoH, UNICEF and other partners including state directors general for health and Expanded Program on Immunization (EPI) officers of all states, gathered from 17 to 21 January 2017 at Juba Grand Hotel to plan on how to reach 2.3 million persons with measles vaccines in the face of a difficult operating environment.

The Syrian Arab RepublicNo new announcements identified.
YemenNo new announcements identified.
NigeriaSee measles immunization campaign announcement above.

UNICEF: 4.7 million children in vaccination campaign against measles in northeast Nigeria
26 January 2017 ABUJA, Nigeria,– In a major vaccination campaign concluding this week, 4.7 million children are being vaccinated in response to a measles outbreak in northeast Nigeria. The campaign is covering the three states most affected by the Boko Haram conflict – Adamawa, Borno and Yobe – where insecurity has limited vaccination efforts. In 2016, there were approximately 25,000 cases of measles among children in Nigeria; 97 per cent of the cases were in children under the age of ten and at least a hundred children died.

WHO Grade 2 Emergencies [to 28 January 2017]
:: Responding to forgotten crises – Together with the United Nations Central Emergency Response Fund
28 January 2017 — With the number and scale of humanitarian crises around the world, some countries have fallen off the global radar. That is the case for countries like the Central African Republic, Libya and Sudan, where pressing needs don’t seem to garner the world’s attention. This can make it difficult to raise the funding necessary to carry out humanitarian response plans.

CameroonNo new announcements identified.
Central African RepublicNo new announcements identified.
Democratic Republic of the Congo No new announcements identified.
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo new announcements identified.
NigerNo new announcements identified.
UkraineNo new announcements identified.

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.
Iraq
:: Iraq: Mosul Humanitarian Response Situation Report No. 17 (16 January – 22 January 2017) [EN/AR/KU]

Syria
:: Syria Arab Republic: Deir-ez-Zor Flash Update No. 2, 28 January 2017
:: 26 Jan 2017 Statement to the Security Council on Syria
:: 28 Jan 2017 Syria Arab Republic: Deir-ez-Zor Flash Update No. 2, 28 January 2017

Yemen
:: Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, Stephen O’Brien Statement to the Security Council on Yemen, New York, 26 January 2017
:: 26 Jan 2017 Launch of the 2017-2018 Regional Refugee and Resilience Plan

Corporate Emergencies
Haiti
:: Haiti: Hurricane Matthew – Situation Report No. 33 (25 January 2017)

Zika virus [to 28 January 2017]

Zika virus [to 28 January 2017]
http://www.who.int/emergencies/zika-virus/en/

Latest Report: now bi-weekly
Zika situation report – 20 January 2017
Full report: http://apps.who.int/iris/bitstream/10665/253604/1/zikasitrep20Jan17-eng.pdf?ua=1
…Analysis
Overall, the global risk assessment has not changed. Zika virus continues to spread geographically to areas where competent vectors are present. Although a decline in cases of Zika infection has been reported in some countries, or in some parts of countries, vigilance needs to remain high.

POLIO [to 28 January 2017]

POLIO [to 28 January 2017]
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 26 January 2017
:: The Executive Board of the World Health Organization is meeting this week in Geneva, Switzerland.  Ministries of Health will agree on the agenda for the May World Health Assembly (WHA), and will review various international public health topics.  Ministers are expected to receive a comprehensive review and overview of the latest global poliovirus epidemiology.

Country Updates [Selected Excerpts]
Afghanistan
:: One new environmental WPV1 positive sample was reported in the past week, from Hilmand province, collected on 23 December 2016.

Pakistan
:: One new environmental WPV1 positive sample was reported in the past week, from Killa Abdullah, Balochistan, collected on 1 January 2017. It is the first WPV1-positive sample detected globally from this year.

WHO & Regional Offices [to 28 January 2017]

WHO & Regional Offices [to 28 January 2017]

140th session of the Executive Board
23 January–1 February 2017, Geneva
[see selected main documents summary and live webcast information above]

Mahmoud Fikri appointed as Regional Director for the WHO Eastern Mediterranean Region
24 January 2017 — WHO’s Executive Board, currently holding its 140th session in Geneva, has appointed Dr Mahmoud Fikri, from United Arab Emirates (UAE) as WHO Regional Director for the Eastern Mediterranean Region (EMRO), following his nomination by the Regional Committee for EMRO in October last year.

Disease Outbreak News [DONs]
:: Yellow fever – Brazil 28 January 2017
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 26 January 2017 ::
:: Hepatitis E – Chad 24 January 2017

Weekly Epidemiological Record, 28 January 2017, vol. 92, 4 (pp. 37–44)
:: Detection of influenza virus subtype A by polymerase chain reaction: WHO external quality assessment programme summary analysis, 2016

WHO Immunization, Vaccines and Biologicals
24 January 2017 Call for Expressions of Interest for a Vaccine-Preventable Disease Surveillance Expertpdf, 254kb Application deadline: 17 February 2017

:: WHO Regional Offices
Selected Press Releases, Announcements

WHO South-East Asia Region SEARO
:: Scale up efforts against leprosy; focus on preventing disabilities in children
28 January 2017

WHO European Region EURO
:: WHO calls for heightened vigilance as avian influenza continues to spread in Europe 26-01-2017
:: First meeting of the Health and SDGs Expert Working Group provides input to roadmap for health and sustainable development in the Region 25-01-2017

WHO Eastern Mediterranean Region EMRO
:: Mahmoud Fikri appointed as Regional Director for the WHO Eastern Mediterranean Region
24 January 2017
:: Trauma care now available in Bartalla 23 January 2017
:: Leishmaniasis continues to affect the lives of tens of thousands of Afghans 22 January 2017

CDC/ACIP [to 28 January 2017]

CDC/ACIP [to 28 January 2017]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/

MMWR Weekly January 27, 2017/No. 1
[Excerpts]
:: Notes from the Field: Impact of Increasing the Number of Ebola Surveillance Officers — Kambia District, Sierra Leone, September 2014–September 2015

Register for upcoming February ACIP meeting
February 22-23, 2017
Deadline for registration:
:: Non-US Citizens: February 1, 2017; US Citizens: February 13, 2017
Registration is NOT required to watch the live meeting webcast or to listen via telephone.

BMGF – Gates Foundation

BMGF – Gates Foundation [to 28 January 2017]
http://www.gatesfoundation.org/Media-Center/Press-Releases
JANUARY 20, 2017
Bill & Melinda Gates Foundation boosts vital work of the University of Washington’s Institute for Health Metrics and Evaluation
SEATTLE (January 25, 2017) – The Bill & Melinda Gates Foundation and University of Washington’s Institute for Health Metrics and Evaluation (IHME) announced today the foundation’s commitment to invest $279 million in IHME to expand its work over the next decade.

The investment will allow IHME to build on its work providing independent health evidence to improve population health. The award complements other investments from the Gates Foundation to further the work of the University of Washington’s Population Health Initiative, which was launched in May 2016 and is establishing a university wide, 25-year vision to advance the health and well-being of people around the world…

Global Fund [to 28 January 2017]

Global Fund [to 28 January 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
26 January 2017

New Global Fund Results Show Further Progress Against HIV, TB and Malaria
GENEVA – Latest results [Results Factsheet – Mid-2016] show that programs supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria have achieved significant increases in the number of people receiving treatment for HIV, diagnosis and treatment for TB and having an insecticide treated net to prevent malaria.

The new results, highlighting cumulative progress by programs supported by the Global Fund since 2002, show that the number of people currently on antiretroviral therapy increased 8.5 percent to 10 million. New smear-positive TB cases detected and treated rose by 9.4 percent to more than 16.6 million. Over 713 million insecticide treated nets were distributed to help families protect themselves from malaria, an increase of 8.1 percent. The results are based on data from the first half of 2016.

“These figures represent 15 years of impressive impact,” said Mark Dybul, the Executive Director of the Global Fund. “Global investments in programs that free communities from the burden of these diseases are achieving results that have saved more than 20 million lives.”
Additional results include: 3.8 million HIV-positive women receiving services to prevent transmission of HIV to unborn children; 334,000 people treated for multidrug-resistant TB; 626 million cases of malaria treated…

Hilleman Laboratories [to 28 January 2017]

Hilleman Laboratories [to 28 January 2017]
http://www.hillemanlabs.org/
10/01/2017

Hilleman Laboratories awarded global patents for Oral Cholera Vaccine
New Delhi, 10 January, 2017: Hilleman Laboratories, a joint-venture partnership between MSD and Wellcome Trust, has announced that it has been awarded a set of global patents for its Oral Cholera Vaccine (OCV). The organisation has partnered with Gotovax AB, a Sweden based company as well as with Incepta Vaccine Ltd, Bangladesh, to develop OCV, with an aim to provide a safe and effective Cholera vaccine at a significantly lower cost than currently available in the market. The OCV patents, assigned to Hilleman Laboratories, have been granted at various patent offices including USA, European Union, Australia, China, Canada and South Africa…

IVI [to 28 January 2017]

IVI [to 28 January 2017]
http://www.ivi.int/

[Undated]
IVI as local host of U.S.-Japan Cooperative Medical Sciences Program’s 19th International Conference on Emerging Infectious Diseases (EID), February 7-10, 2017
The U.S.-Japan Cooperative Medical Sciences Program’s 19th International Conference on Emerging Infectious Diseases (EID) and associated Workshop on Cholera and Other Bacterial Enteric Infections will be on February 7-10, 2017 at the Novotel Seoul Ambassador Gangnam Hotel. Organized by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), the Japanese Ministries of Health, Labor and Welfare (MHLW) and Education, Culture, Sports, Science and Technology (MEXT), and the Japan Agency for Medical Research and Development (AMED), IVI is the local host of this year’s conference.

Since 1996, the United States-Japan Cooperative Medical Sciences Program has been convening the EID conference annually in alternating countries. It serves as a venue for panel meetings and discussion of cross-cutting topics related to infectious disease research to promote international cooperation in research efforts in response to new, emerging infectious disease challenges of Asia and the greater Pacific region. Participants include researchers, government and public health officials, and representatives from academia and other public and private institutions from countries within the Pacific Rim region, including Korea, Japan, and the United States.

For more information about EID and the Workshop, please visit:
https://respond.niaid.nih.gov/conferences/USJapanCMSP2017/Pages/default.aspx

Fondation Merieux [to 28 January 2017]

Fondation Merieux [to 28 January 2017]
http://www.fondation-merieux.org/news

Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
25 January 2017, Erbil (Iraq)
Inauguration of a Mother and Child medical center in Erbil (Iraq) in partnership with Fondation Mérieux
Fondation Mérieux helped to build a medical center in Erbil, in Iraqi Kurdistan. The Pauline-Marie Jaricot Mother and Child center was commissioned and opened on December 7, 2016. It provides comprehensive, quality medical care for displaced people, of whom there are many in the Iraqi Kurdistan region. These people now have access to diagnosis and targeted medical treatment.

Wellcome Trust [to 28 January 2017]

Wellcome Trust [to 28 January 2017]
https://wellcome.ac.uk/news

News / Published: 24 January 2017
New partnerships to tackle health and environmental issues
We’ve awarded four new research partnerships a total of £29m to tackle global environmental and health challenges.
The scientists – from Australia, South America and the UK – are receiving the funding as part of Wellcome’s £75m commitment to population and planetary health.
Two of the partnerships will focus on the health challenges of diverse urban environments.
:: Professor Ana Diez Roux, at Drexel University in the USA, will study the links between health and the physical, natural and economic environments in highly urbanised Latin America.
:: Prof Rebekah Brown, at Monash University in Australia, will investigate how nature-based solutions can help to improve the sanitation and environment of people living in informal urban settlements in Fiji and Indonesia.
The other two partnerships will focus on food systems and choices.
:: Prof Charles Godfray, at Oxford University, will look at the environmental and health impacts of animal-sourced food, mainly in the UK, and what their future could look like.
:: Prof Alan Dangour, at the London School of Hygiene and Tropical Medicine, will build on work we’ve already funded to explore what factors form sustainable and healthy food systems in India and South Africa…

Industry Watch [to 28 January 2017]

Industry Watch [to 28 January 2017]
:: Pfizer Announces Positive Top-Line Results from Phase 2 Study of Investigational Clostridium difficile Vaccine for the Prevention of C. difficile Infection
Pfizer’s C. difficile Vaccine Candidate to Commence Phase 3 Study in First Half of 2017
C. difficile is an Increasing Worldwide Concern Associated with Approximately 29,000 Annual Deaths in the U.S. Alone
January 26, 2017
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the Phase 2 study evaluating the Company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized Phase 2 study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis,1 by inducing a functional antibody response capable of neutralizing the two main disease-causing toxins produced by C. difficile (toxins A and B).2 …

PATH [to 28 January 2017]

PATH [to 28 January 2017]
http://www.path.org/news/index.php
Press release | January 23, 2017

Quansys Biosciences launches Q-Plex (TM) Micronutrient Array to combat malnutrition
Effective and affordable new tool can identify up to seven key nutrition markers and malaria infection with a single test.
…The Q-PlexTM Micronutrient Array responds. Developed through a collaboration between the global health nonprofit PATH and bioscience developer and manufacturer Quansys, the test can simultaneously measure up to seven nutrition-related biomarkers in a single sample of human serum. Using the test, countries and researchers can gather national data on micronutrient deficiency status and use it to implement and assess targeted interventions. Results also help leaders accurately establish the magnitude of the deficiency, identify subpopulations at greatest risk, and monitor the efficacy and progress of nutrition programs

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

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

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes.

If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

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

22 CASE STUDIES WHERE PHASE 2 AND PHASE 3 TRIALS HAD DIVERGENT RESULTS

FDA
January 2017 :: 44 pages
Overview
Pre-market clinical testing usually progresses in phases, with increasingly rigorous methods at each phase. Product candidates that appear insufficiently safe or effective at one phase may not proceed to the next phase. Roughly 9 in 10 drugs/biologics that are tested in humans are never submitted to FDA for approval.[1] Typically, a candidate drug is submitted to the FDA for marketing approval after phase 3 testing. In recent years, there has been growing interest in exploring alternatives to requiring phase 3 testing before product approval, such as relying on different types of data and unvalidated surrogate endpoints.

To better understand the nature of the evidence obtained from many phase 2 trials and the contributions of phase 3 trials, we identified, based on publicly available information, 22 case studies of drugs, vaccines and medical devices since 1999 in which promising phase 2 clinical trial results were not confirmed in phase 3 clinical testing.* Phase 3 studies did not confirm phase 2 findings of effectiveness in 14 cases, safety in 1 case, and both safety and effectiveness in 7 cases. These unexpected results could occur even when the phase 2 study was relatively large and even when the phase 2 trials assessed clinical outcomes. In two cases, the phase 3 studies showed that the experimental product increased the frequency of the problem it was intended to prevent.

This paper is not intended to assess why each of these unexpected results occurred or why further product development was not pursued. Rather, these cases, chosen from a large pool of similar examples, illustrate the ways in which controlled trials of appropriate size and duration contribute to the scientific understanding of medical products.

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

BMC Medical Ethics

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 28 January 2017)

Research article
Dynamic Consent: a potential solution to some of the challenges of modern biomedical research
Isabelle Budin-Ljøsne, Harriet J. A. Teare, Jane Kaye, Stephan Beck, Heidi Beate Bentzen, Luciana Caenazzo, Clive Collett, Flavio D’Abramo, Heike Felzmann, Teresa Finlay, Muhammad Kassim Javaid, Erica Jones, Višnja Katić, Amy Simpson and Deborah Mascalzoni
BMC Medical Ethics 2017 18:4
Published on: 25 January 2017

Abstract
Background
Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.

Methods
An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.

Results
Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.

Conclusions
Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.

BMC Public Health

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 January 2017)

Research article
Demography, maternal health and the epidemiology of malaria and other major infectious diseases in the rural department Tsamba-Magotsi, Ngounie Province, in central African Gabon
Sub-Saharan Africa is undergoing an epidemiological transition from a predominance of infectious diseases to non-communicable and lifestyle related conditions. However, the pace of this transition and the patt…
R. Zoleko Manego, G. Mombo-Ngoma, M. Witte, J. Held, M. Gmeiner, T. Gebru, B. Tazemda, J. Mischlinger, M. Groger, B. Lell, A. A. Adegnika, S. T. Agnandji, P. G. Kremsner, B. Mordmüller, M. Ramharter and P. B. Matsiegui
BMC Public Health 2017 17:130
Published on: 28 January 2017

Research article
The impact of a vaccine scare on parental views, trust and information needs: a qualitative study in Sydney, Australia
Vaccine safety scares can undermine public confidence in vaccines and decrease immunisation rates. Understanding and addressing parental concerns arising during such scares can assist in lessening their impact…
Catherine King and Julie Leask
BMC Public Health 2017 17:106
Published on: 23 January 2017

Epidemiology and Infection – Volume 145 – Issue 3 – February 2017

Epidemiology and Infection
Volume 145 – Issue 3 – February 2017
http://journals.cambridge.org/action/displayIssue?jid=HYG&tab=currentissue

REVIEW Poliovirus
Wild and vaccine-derived poliovirus circulation, and implications for polio eradication
P. L. LOPALCO
DOI: https://doi.org/10.1017/S0950268816002569
Published online: 21 November 2016, pp. 413-419

Abstract
Polio cases due to wild virus are reported by only three countries in the world. Poliovirus type 2 has been globally eradicated and the last detection of poliovirus type 3 dates to November 2012. Poliovirus type 1 remains the only circulating wild strain; between January and September 2016 it caused 26 cases (nine in Afghanistan, 14 in Pakistan, three in Nigeria). The use of oral polio vaccine (OPV) has been the key to success in the eradication effort. However, paradoxically, moving towards global polio eradication, the burden caused by vaccine-derived polioviruses (VDPVs) becomes increasingly important. In this paper circulation of both wild virus and VDPVs is reviewed and implications for the polio eradication endgame are discussed. Between April and May 2016 OPV2 cessation has been implemented globally, in a coordinated switch from trivalent OPV to bivalent OPV. In order to decrease the risk for cVDPV2 re-emergence inactivated polio vaccine (IPV) has been introduced in the routine vaccine schedule of all countries. The likelihood of re-emergence of cVDPVs should markedly decrease with time after OPV cessation, but silent circulation of polioviruses cannot be ruled out even a long time after cessation. For this reason, immunity levels against polioviruses should be kept as high as possible in the population by the use of IPV, and both clinical and environmental surveillance should be maintained at a high level.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines) – Volume 13, Issue 1, 2017

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 13, Issue 1, 2017
http://www.tandfonline.com/toc/khvi20/current

Review
From discovery to licensure, the Adjuvant System story
Pages: 19-33
Nathalie Garçon & Alberta Di Pasquale
ABSTRACT
Adjuvants are substances added to vaccines to improve their immunogenicity. Used for more than 80 years, aluminum, the first adjuvant in human vaccines, proved insufficient to develop vaccines that could protect against new challenging pathogens such as HIV and malaria. New adjuvants and new combinations of adjuvants (Adjuvant Systems) have opened the door to the delivery of improved and new vaccines against re-emerging and difficult pathogens. Adjuvant Systems concept started through serendipity. The access to new developments in technology, microbiology and immunology have been instrumental for the dicephering of what they do and how they do it. This knowledge opens the door to more rational vaccine design with implications for developing new and better vaccines.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines) – Volume 13, Issue 1, 2017

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 13, Issue 1, 2017
http://www.tandfonline.com/toc/khvi20/current

Review
From discovery to licensure, the Adjuvant System story
Pages: 19-33
Nathalie Garçon & Alberta Di Pasquale
ABSTRACT
Adjuvants are substances added to vaccines to improve their immunogenicity. Used for more than 80 years, aluminum, the first adjuvant in human vaccines, proved insufficient to develop vaccines that could protect against new challenging pathogens such as HIV and malaria. New adjuvants and new combinations of adjuvants (Adjuvant Systems) have opened the door to the delivery of improved and new vaccines against re-emerging and difficult pathogens. Adjuvant Systems concept started through serendipity. The access to new developments in technology, microbiology and immunology have been instrumental for the dicephering of what they do and how they do it. This knowledge opens the door to more rational vaccine design with implications for developing new and better vaccines.