PLoS One
http://www.plosone.org/
[Accessed 13 Oct 2018 ]

Research Article
Low coverage of influenza vaccination among Chinese children aged 12-23 months: Prevalence and associated factors
Joseph T. F. Lau, Catalina S. M. Ng, Anise M. S. Wu, Yee Ling Ma, Mason M. C. Lau
Research Article | published 10 Oct 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0205561

Research Ethics
Volume 14 Issue 3, July 2018
http://journals.sagepub.com/toc/reab/current

Original Article: Empirical
Research ethics, informed consent and the disempowerment of First Nation peoples
Juan M Tauri
First Published November 14, 2017; pp. 1–14
Preview
Recently, Indigenous commentators have begun to analyse the way in which institutional Research Ethics Boards (REBs) engage with Indigenous researchers and participants, respond to Indigenous peoples’ concerns with academic research activities, and scrutinise the ethics proposals of Indigenous scholars. Of particular concern for Indigenous commentators is that the work of REBs often results in the marginalisation of Indigenous approaches to knowledge construction and dissemination, especially in relation to the vexed issue of informed consent. Based on analysis of the results of research with Indigenous researchers and research participants, this paper argues that institutionalised REBs’ preference for ‘universal’ and ‘individualised’ approaches for determining ethical research conduct marginalises Indigenous approaches to ethical research conduct. The paper concludes by calling for a decolonisation of REB processes through recognition of the validity of communal processes for attaining the informed consent of Indigenous research participants.

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 13 Oct 2018 ]

Research
|   11 October 2018
Integration of postpartum care into child health and immunization services in Burkina Faso: findings from a cross-sectional study
The Missed Opportunities for Maternal and Infant Health (MOMI) project, which aimed at upgrading maternal and infant postpartum care (PPC), implemented a package of interventions including the integration of maternal PPC in infant immunization services in 12 health facilities in Kaya Health district in Burkina Faso from 2013 to 2015. This paper assesses the coverage and the quality of combined mother-infant PPC in reproductive, maternal, newborn and child health services (RMNCH).
Authors: Danielle Yugbaré Belemsaga, Anne Goujon, Aristide Bado, Seni Kouanda, Els Duysburgh, Marleen Temmerman and Olivier Degomme

Science         
12 October 2018  Vol 362, Issue 6411
http://www.sciencemag.org/current.dtl
Special Issue – Brain Development

Policy Forum
Return of results and data to study participants
By Susan M. Wolf, Barbara J. Evans
Science12 Oct 2018 : 159-160 Restricted Access
A recent report urges progress but builds barriers to research participants’ access
Summary
Researchers conducting imaging, environmental health, and genetics studies have offered participants their research findings for years, publishing data on this experience and producing consensus guidelines (1–5). Research participants have articulated the value in the return of results and data (6). The National Academies recently issued a report at the request of the National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (7) that focuses on the return of results in studies with human biospecimens. It proclaims support for the interests of research participants, endorses the importance of offering participants their individual-specific results, and advocates assessing the value of results from the standpoint of participants. Unfortunately, in our view, the report’s announced commitment to participant-centered progress is undercut by its actual recommendations. We believe the report creates major roadblocks to the return of data and results and would constrict participants’ existing rights of access.

Tropical Medicine & International Health
Volume 23, Issue 10   Pages: i-iv, 1045-1156  October 2018
https://onlinelibrary.wiley.com/toc/13653156/current

Editorial   Free Access
Stakeholder participation on the path to universal health coverage: the use of evidence‐informed deliberative processes
Rob Baltussen, Maarten Jansen, Leon Bijlmakers
Pages: 1071-1074
First Published: 15 August 2018

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Edited by Angus Thomson, Gaëlle Vallée-Tourangeau, L. Suzanne Suggs
Editorial  Open access
Strategies to increase vaccine acceptance and uptake: From behavioral insights to context-specific, culturally-appropriate, evidence-based communications and interventions
Angus Thomson, Gaëlle Vallée-Tourangeau, L. Suzanne Suggs
Pages 6457-6458
[See Milestones/Perspective above for full text]

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Abstract only
‘Hesitant compliers’: Qualitative analysis of concerned fully-vaccinating parents
Stephanie L. Enkel, Katie Attwell, Thomas L. Snelling, Hayley E. Christian
Pages 6459-6463

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Abstract only
‘Hesitant compliers’: Qualitative analysis of concerned fully-vaccinating parents
Stephanie L. Enkel, Katie Attwell, Thomas L. Snelling, Hayley E. Christian
Pages 6459-6463

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Abstract only
What is ‘confidence’ and what could affect it?: A qualitative study of mothers who are hesitant about vaccines
Judith A. Mendel-Van Alstyne, Glen J. Nowak, Ann L. Aikin
Pages 6464-6472

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Abstract only
Vaccine decision-making begins in pregnancy: Correlation between vaccine concerns, intentions and maternal vaccination with subsequent childhood vaccine uptake
M.H. Danchin, J. Costa-Pinto, K. Attwell, H. Willaby, … H. Marshall
Pages 6473-6479

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Abstract only
Sharing knowledge about immunisation (SKAI): An exploration of parents’ communication needs to inform development of a clinical communication support intervention
Nina J. Berry, Margie Danchin, Lyndal Trevena, Holly O. Witteman, … Julie Leask
Pages 6480-6490

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Open access
Innovative vaccine delivery strategies in response to a cholera outbreak in the challenging context of Lake Chilwa. A rapid qualitative assessment
Leonard W. Heyerdahl, Bagrey Ngwira, Rachel Demolis, Gabriel Nyirenda, … Elise Guillermet
Pages 6491-6496

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Open access
A rapid qualitative assessment of oral cholera vaccine anticipated acceptability in a context of resistance towards cholera intervention in Nampula, Mozambique
Rachel Démolis, Carlos Botão, Léonard W. Heyerdahl, Bradford D. Gessner, … Elise Guillermet
Pages 6497-6505

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Discussion   No access
Hearts, minds, nudges and shoves: (How) can we mobilise communities for vaccination in a marketised society?
Katie Attwell, David T. Smith
Pages 6506-6508

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Discussion   Abstract only
Lessons from an online vaccine communication project
Gary Finnegan, Daphne Holt, Peter M. English, Steffen Glismann, … Paolo Bonanni
Pages 6509-6511

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Discussion   Abstract only
Lessons from an online vaccine communication project
Gary Finnegan, Daphne Holt, Peter M. English, Steffen Glismann, … Paolo Bonanni
Pages 6509-6511

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Abstract only
Flu vaccination communication in Europe: What does the government communicate and how?
Anne Wiebke Ohlrogge, L. Suzanne Suggs
Pages 6512-6519

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article   Open access
Identification of preliminary core outcome domains for communication about childhood vaccination: An online Delphi survey
Jessica Kaufman, Rebecca Ryan, Simon Lewin, Xavier Bosch-Capblanch, … Sophie Hill
Pages 6520-6528

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Abstract only
Vaccine hesitancy communication: What counts as evidence
John Parrish-Sprowl
Pages 6529-6530

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Review article  Abstract only
Midwives’ attitudes, beliefs and concerns about childhood vaccination: A review of the global literature

1. Attwell, K.E. Wiley, C. Waddington, J. Leask, T. Snelling

Pages 6531-6539

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Open access
Motors of influenza vaccination uptake and vaccination advocacy in healthcare workers: Development and validation of two short scales
Gaëlle Vallée-Tourangeau, Marianne Promberger, Karis Moon, Ana Wheelock, … Nick Sevdalis
Pages 6540-6545

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article   Abstract only
Motors of influenza vaccination uptake and vaccination advocacy in healthcare workers: A comparative study in six European countries
George Kassianos, Ernest Kuchar, Aneta Nitsch-Osuch, Jan Kyncl, … Gaëlle Vallée-Tourangeau
Pages 6546-6552

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Discussion  No access
Motivational interviewing: A promising tool to address vaccine hesitancy
Arnaud Gagneur, Virginie Gosselin, Ève Dubé
Pages 6553-6555

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article  Abstract only
Vaccine hesitancy, refusal and access barriers: The need for clarity in terminology
Helen Bedford, Katie Attwell, Margie Danchin, Helen Marshall, … Julie Leask
Pages 6556-6558

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article   Abstract only
Factors associated with routine childhood vaccine uptake and reasons for non-vaccination in India: 1998–2008
Mark Rohit Francis, Hanna Nohynek, Heidi Larson, Vinohar Balraj, … J. Pekka Nuorti
Pages 6559-6566

Vaccine
Volume 36, Issue 44, Pages 6457-6578 (22 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/44
Vaccine Hesitancy: Towards a Better Understanding of Drivers and Barriers to Awareness, Acceptance and Activation

Research article   Abstract only
A cluster randomized trial to determine the effectiveness of a novel, digital pendant and voice reminder platform on increasing infant immunization adherence in rural Udaipur, India
Ruchit Nagar, Preethi Venkat, Logan D. Stone, Kyle A. Engel, … Mohammed Shahnawaz
Pages 6567-6577

Value in Health                   
October 2018 Volume 21, Issue 10, p1133-1268
http://www.valueinhealthjournal.com/current

ISPOR REPORTS
Economic Analysis of Vaccination Programs
Josephine Mauskopf, Baudouin Standaert, Mark P. Connolly, Anthony J. Culyer, Louis P. Garrison, Raymond Hutubessy, Mark Jit, Richard Pitman, Paul Revill, Johan L. Severens
p1133–1149
Published in issue: October 2018
Abstract
This report provides recommendations for budget holders and decision makers in high-, middle, and low-income countries requiring economic analyses of new vaccination programs to allocate scarce resources given budget constraints. ISPOR’s Economic Evaluation of Vaccines Designed to Prevent Infectious Disease: Good Practices Task Force wrote guidelines for three analytic methods and solicited comments on them from external reviewers. Cost-effectiveness analyses use decision-analytic models to estimate cumulative changes in resource use, costs, and changes in quality- or disability-adjusted life-years attributable to changes in disease outcomes. Constrained optimization modeling uses a mathematical objective function to be optimized (e.g. disease cases avoided) for a target population for a set of interventions including vaccination programs within established constraints. Fiscal health modeling estimates changes in net present value of government revenues and expenditures attributable to changes in disease outcomes. The task force recommends that those designing economic analyses for new vaccination programs take into account the decision maker’s policy objectives and country-specific decision context when estimating: uptake rate in the target population; vaccination program’s impact on disease cases in the population over time using a dynamic transmission epidemiologic model; vaccination program implementation and operating costs; and the changes in costs and health outcomes of the target disease(s). The three approaches to economic analysis are complementary and can be used alone or together to estimate a vaccination program’s economic value for national, regional, or subregional decision makers in high-, middle-, and low-income countries.

Value in Health                   
October 2018 Volume 21, Issue 10, p1133-1268
http://www.valueinhealthjournal.com/current
ISPOR REPORTS

Vaccination Programs: Economic and Leadership Considerations
Kenneth Y. Hartigan-Go
p1150–1151
Published online: September 19, 2018
health program in your country. With finite resources available to you, you must ensure to invest wisely to protect and preserve the health of the greater society. Suppose, in particular, you are considering an immunization program that will prevent communicable illness in a large population in a place where health care services are less than ideal. If funds are allocated to immunization, will that choice deprive another program of needed funding? How will you decide how to spend the limited resources? More specifically, what kinds of information are essential in helping you and your fellow ministers decide on which of the numerous competing priorities to invest in.

Value in Health                   
October 2018 Volume 21, Issue 10, p1133-1268
http://www.valueinhealthjournal.com/current

SYSTEMATIC LITERATURE REVIEW
Model Comparisons of the Effectiveness and Cost-Effectiveness of Vaccination: A Systematic Review of the Literature
Mélanie Drolet, Élodie Bénard, Mark Jit, Raymond Hutubessy, Marc Brisson
p1250–1258
Published online: May 24, 2018
Abstract
Objectives
To describe all published articles that have conducted comparisons of model-based effectiveness and cost-effectiveness results in the field of vaccination. Specific objectives were to 1) describe the methodologies used and 2) identify the strengths and limitations of the studies.
Methods
We systematically searched MEDLINE and Embase databases for studies that compared predictions of effectiveness and cost-effectiveness of vaccination of two or more mathematical models. We categorized studies into two groups on the basis of their data source for comparison (previously published results or new simulation results) and performed a qualitative synthesis of study conclusions.
Results
We identified 115 eligible articles (only 5% generated new simulations from the reviewed models) examining the effectiveness and cost-effectiveness of vaccination against 14 pathogens (69% of studies examined human papillomavirus, influenza, and/or pneumococcal vaccines). The goal of most of studies was to summarize evidence for vaccination policy decisions, and cost-effectiveness was the most frequent outcome examined. Only 33%, 25%, and 3% of studies followed a systematic approach to identify eligible studies, assessed the quality of studies, and performed a quantitative synthesis of results, respectively. A greater proportion of model comparisons using published studies followed a systematic approach to identify eligible studies and to assess their quality, whereas more studies using new simulations performed quantitative synthesis of results and identified drivers of model conclusions. Most comparative modeling studies concluded that vaccination was cost-effective.
Conclusions
Given the variability in methods used to conduct/report comparative modeling studies, guidelines are required to enhance their quality and transparency and to provide better tools for decision making.

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

Pediatric Quality & Safety
September 19, 2018
Improving Human Papilloma Virus Vaccination Rates at an Urban Pediatric Primary Care Center
N Brodie, KE McPeak –
Despite compelling evidence regarding its safety and efficacy, human papilloma virus vaccination rates remain low nationally with high rates of missed vaccination opportunities. Provider recommendation is the most important factor in determining vaccine approval by families; yet, studies show that providers are hesitant to strongly recommend vaccination, especially at younger ages. We hypothesized that educational and quality improvement interventions targeting our clinical team would decrease rates of missed opportunities to vaccinate patients aged 11–13 years and improve vaccination rates among patients aged 9–10 years old.

Frontiers in Medicine
doi: 10.3389/fmed.2018.00297
Review ARTICLE
Dealing with uncertainty in vaccine development: the malaria case
M Roestenberg, I Kamerling, SJ de Visser –
[Initial text]
Vaccines can be extremely cost-effective public health measures. Unfortunately the research and development (R&D) of novel vaccines is suffering from rising costs and declining success rates. Because many vaccines target low- and middle income markets (LMIC), output needs to be maintained at a constrained budget. In addition, scientific neglect and political uncertainty around reimbursement decisions make it an unattractive arena for private investors. The vaccine development pipeline for LMIC thus is in need for a different, sustainable and cost-effective development model…

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 13 Oct 2018  
[No new, unique, relevant content]

BBC
http://www.bbc.co.uk/
Accessed 13 Oct 2018  
[No new, unique, relevant content]

The Economist
http://www.economist.com/
Accessed 13 Oct 2018  
[No new, unique, relevant content]

Financial Times
http://www.ft.com/home/uk
Accessed 13 Oct 2018  
[No new, unique, relevant content]

Forbes
http://www.forbes.com/
Accessed 13 Oct 2018
[No new, unique, relevant content]

Foreign Affairs
http://www.foreignaffairs.com/
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 13 Oct 2018  
[No new, unique, relevant content]

The Guardian
http://www.guardiannews.com/
Accessed 13 Oct 2018
[No new, unique, relevant content]

New Yorker
http://www.newyorker.com/
Accessed 13 Oct 2018
[No new, unique, relevant content]
 
 
New York Times
http://www.nytimes.com/
Accessed 13 Oct 2018
Africa
Oct. 13, 2018
Battles Over Safe Ebola Burials Complicate Work in Congo
BENI, Congo — A runaway hearse carrying an Ebola victim has become the latest example of sometimes violent community resistance complicating efforts to contain a Congo outbreak — and causing a worrying new rise in cases.
The deadly virus’ appearance for the first time in the far northeast has sparked fear. Suspected contacts of infected people have tried to slip away. Residents have assaulted health teams. The rate of new Ebola cases has more than doubled since the start of this month, experts say.
Safe burials are particularly sensitive as some outraged family members reject the intervention of health workers in the deeply personal moment, even as they put their own lives at risk…

Africa
Oct. 11, 2018
WHO Sees Congo’s Ebola Outbreak Lasting 3-4 Months at Least
GENEVA — Democratic Republic of Congo’s Ebola outbreak is expected to last several months and could spread to Uganda or Rwanda, which are well prepared but have not approved use of a vaccine, the World Health Organization said on Thursday.
The most concerning area is the city of Beni in Congo’s North Kivu province where dozens of people who may have been exposed to the deadly disease are hiding from health workers, emergency response chief Peter Salama said.
“We anticipate that now we’ll be looking at least another 3-4 months in order to really stem this outbreak, with a strong focus in Beni and surrounding areas,” Salama said. “I’d say that’s the best case scenario.”

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 13 Oct 2018
[No new, unique, relevant content]
 
 
Washington Post
http://www.washingtonpost.com/
Accessed 13 Oct 2018
[No new, unique, relevant content]
 

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 13 Oct 2018
[No new relevant content]

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 13 Oct 2018
[No new relevant content]

CSIS
https://www.csis.org/
Accessed 13 Oct 2018
Commentary
Tuberculosis on the World Stage: Will Political Attention Translate into Action and Accountability?
October 12, 2018

Council on Foreign Relations
http://www.cfr.org/
Accessed 13 Oct 2018
[No new relevant content]

Milestones :: Perspectives

IAVI Acquires Aeras TB Vaccine Clinical Programs and Assets

Data from Two Phase II Clinical Trials Conducted by Aeras and Partners Indicate Promise for Future of TB Vaccine Development

NEW YORK – OCTOBER 1, 2018 – The International AIDS Vaccine Initiative (IAVI) and Aeras, a nonprofit organization dedicated to developing tuberculosis (TB) vaccines, today announced the transfer to IAVI of Aeras’ TB vaccine clinical research programs and assets, consisting of certain clinical staff, clinical programs, biorepository, funding commitments, and other assets.

The transaction, effective today, will enable the continuity of Aeras’ core TB vaccine clinical programs and will expand IAVI’s clinical development capabilities and network, incorporating an experienced clinical team and South African clinical partner network with a strong track record in later-stage clinical trials and work with adolescent and adult populations.

This agreement comes as the New England Journal of Medicine (NEJM) published the results of a clinical study conducted by Aeras in collaboration with GSK, evaluating GSK’s investigational TB vaccine candidate, M72/AS01E. The Phase IIb efficacy study showed that the vaccine protected against active pulmonary TB disease, with an overall vaccine efficacy of 54 percent. This finding, if confirmed in follow-up studies, would represent a breakthrough in the decades-long quest to develop an effective TB vaccine. The study involved 3,573 HIV-negative adults in three countries in Africa (Kenya, South Africa, and Zambia).

These results follow another Aeras Phase II study recently published in the NEJM showing the potential to prevent sustained TB infection among high-risk adolescents. The study involved the currently available bacille Calmette-Guerin (BCG) vaccine and an experimental subunit vaccine candidate, H4:IC31®, which uses the IC31® adjuvant available under license from Valneva. The study was conducted through a partnership between Aeras and Sanofi.

Mark Feinberg, M.D., Ph.D., president and CEO, IAVI, said, “Aeras’ contributions to these two important studies have built excitement in the field, demonstrating that an effective TB vaccine may be achievable. The transfer of Aeras research capabilities to IAVI will enable this important work to continue.” Dr. Feinberg continued, “There is extensive overlap among individuals and communities hit hardest by TB and HIV/AIDS; TB is the single biggest killer of people living with HIV, and, in some parts of the world, the HIV pandemic has fueled the spread of TB. The expertise of the Aeras clinical operations team and South African network will enable IAVI to strengthen its clinical development capacity and enhance its ability to address HIV, TB, and other important global health challenges. We are looking forward to working with public and private sector partners to develop new technologies and programs to help control the TB pandemic.”

Jacqueline Shea, Ph.D., CEO, Aeras, said, “Aeras is proud of the contribution it has made to the field of TB vaccine research and development and the role that it has played in two recent groundbreaking clinical efficacy trials. For more than two decades, Aeras has formed partnerships with commercial biopharmaceutical companies, other nonprofits, researchers, funders, and global health experts in its mission to advance TB vaccines for the world. We believe that the time is right to join the expertise within Aeras and IAVI to build on the recent findings and accelerate progress toward new, more effective TB vaccines. We believe such progress will also require additional partnerships among like-minded and committed organizations.”

Eric Goosby, M.D., U.N. Secretary-General’s Special Envoy on Tuberculosis and board chair, IAVI, said, “Following the first-ever United Nations high-level meeting on TB, it is important to emphasize that a vaccine is necessary to achieve control over TB on a global level. Without vaccines to both prevent and treat the disease, the pandemic will continue. These recent studies bring us one step closer to a solution.”

Milestones :: Perspectives

Ebola – Democratic Republic of the Congo

Ebola virus disease – Democratic Republic of the Congo
Disease Outbreak News (DONs)  4 October 2018

The response to the Ebola virus disease (EVD) outbreak in the Democratic Republic of the Congo is at a critical juncture. WHO faces a precarious situation given recent increases in insecurity, incidents of community mistrust, and increased geographical spread.

The period of mourning and general strike (ville morte) in Beni, Butembo and Mabalako has officially ended; the ville morte was organized by civil society leaders following an attack in Beni on 22 September, in which 21 people were killed. Activities that had slowed during the ville morte period included health workers being unable to reach and monitor the health of Ebola patient contacts, social mobilization and community engagement efforts significantly slowed or suspended, risk communications seriously constrained or suspended in areas highly impacted by EVD, and severe limitations on field teams’ ability to investigate alerts of suspected cases and carry out safe and dignified burials. WHO operations are currently back to full scale; however, WHO remains vigilant given ongoing security constraints.

The Ministry of Health (MoH), WHO and partners continue to work closely with people in the affected areas. Most communities support the response efforts and are open to vaccination and treatment; collaboration between communities and local authorities is ongoing to overcome the reluctance and mistrust which has developed in some places. Faced with rumours and misinformation, some families have chosen to care for sick relatives at home, increasing the risk of transmission to caregivers, family and children. Some patients have also left health facilities to seek alternative care, or actively avoid follow-up from health workers. Despite concerted efforts by local community leaders to ensure safe and dignified burials, in some cases these are rejected in favour of traditional practices. Avoiding contact with health workers, home care and unsafe burials all increase the risk to patients themselves, caregivers, children and other family members, and to health/frontline workers, and have contributed to the spread of the outbreak.

The affected areas now cover hundreds of kilometres, including a confirmed case who has moved into a ‘red zone’ – a highly insecure and challenging environment where implementing response activities is extremely difficult. The geographic expansion further strains frontline resources, as an effective Ebola response requires hubs established in multiple locations, as close as possible to the affected population…

…Public health response

The MoH continues to strengthen response measures, with support from WHO and partners. Priorities include coordinating the response, surveillance, contact tracing, laboratory capacity, IPC measures, clinical management of patients, vaccination, risk communication and community engagement, psychosocial support, safe and dignified burials (SDB), cross-border surveillance and preparedness activities in neighbouring provinces and countries.

:: As of 2 October, over 200 experts have been deployed by WHO to support response activities including emergency coordinators, epidemiologists, laboratory experts, logisticians, clinical care specialists, communicators and community engagement specialists.

:: Over 5700 contacts have been registered, of which approximately 1900 remain under surveillance as of 2 October 2 . Following the conclusion of a ville morte imposed in Beni, Butembo and Mabalako Health Zones, there has been a marked improvement in the proportion of follow-up contacts on the day of reporting, with the proportion rising to 93% (1768/1900) from 78% (1401/1785) seven days prior. Beni Health Zone has the greatest challenges in contact tracing as a result of the deteriorating security situation.

:: As of 2 October, 69 vaccination rings have been defined in addition to 26 rings of health and frontline workers. To date, 13,758 people consented and were vaccinated, including 5678 health or frontline workers and 2915 children. Ebola Treatment Centres (ETCs) are operational in Beni and Mangina with support from the Alliance for International Medical Action (ALIMA) and Médecins Sans Frontières (MSF), respectively. MSF Switzerland and the MoH are supporting an ETC in Butembo. International Medical Corps (IMC) is supporting the recently opened Makeke ETC in Ituri Province. MSF and the MoH are setting up a 12-bed isolation facility in Kasenyi. An isolation unit is being developed from existing facilities in Tchomia.

:: WASH and IPC activities are ongoing in the Democratic Republic of the Congo and are supported by several partners in the field. Numerous activities have occurred in health facilities in the affected areas including facility assessments, decontamination of centres, establishment of triage areas and training on standard precautions as well as Ebola-specific IPC measures. A comprehensive plan to strengthen IPC in 200 health facilities, with WHO’s support, aims to: train medical staff; provide IPC kits; and replace incinerated materials in health facilities and households.

:: The MoH, WHO, UNICEF, Red Cross and partners are intensifying activities to engage with local communities in the affected areas. Due to conditions imposed by a community-declared ville morte from 24-28 September 2018, social mobilization teams were in lockdown for five days in Beni and unable to engage with communities; the situation in Beni has since improved. Engagement with local leaders in Ndindi in the past weeks has helped increase community ownership, with positive signs that leaders are actively reporting suspected cases through a telephone hotline. More collaboration has also been observed between local authorities and community focal points. Local frontline community outreach workers are collaborating with Ebola response teams to strengthen community engagement and psychosocial support in contact tracing, patient care, SDBs and vaccination of close contacts. In Butembo, community engagement was strengthened through collaboration with a popular singer, Mayaya Santa, producing a song with key messages about Ebola response. The activation of Tchomia’s communication commission has been a priority, and a meeting organized with two religious networks successfully reached 233 leaders from 141 churches in Tchomia Health Zone; youth leaders and motor taxi associations were also engaged as part of the meeting…

:: 09: Situation report on the Ebola outbreak in North Kivu  4 October 2018

…Case Management

:: Ebola Treatment Centres (ETCs) continue to provide therapeutics under the monitored emergency use of unregistered and experimental interventions (MEURI) protocol, in collaboration with the MoH and the Institut National de Recherche Biomédicale (INRB). WHO is providing technical clinical expertise onsite and is assisting with the creation of a data safety management board.

:: As of 1 October 2018, 47 patients have received investigational Ebola therapeutics, 26 treated with mAb 114, 10 with Remdesivir and 8 with Zmapp. A new molecule, Regeneron, has been used for the first time in three patients in Beni.

Milestones :: Perspectives

OCV – Yemen, Zimbabwe

Health workers in Yemen reach more than 306,000 people with cholera vaccines during four-day pause in fighting – WHO, UNICEF
Vaccination campaign covers war-torn areas of Hudaydah and Ibb
GENEVA/NEW YORK 5 October 2018 – More than 306,000 people in Yemen, including over 164,000 children under the age of 15, were vaccinated against cholera as part of a joint WHO-UNICEF campaign that concluded today. The number is expected to go up as reports of the final day of the campaign come in. The six-day vaccination effort, carried out by 3,000 health workers in three districts of Hudaydah and Ibb, was made possible by a pause in fighting – known as ‘Days of Tranquility’ – agreed by parties to the conflict.

“The success of this vaccination campaign shows what we can collectively achieve for children and families in Yemen when the fighting stops and humanitarian access opens up,” said UNICEF Executive Director Henrietta Fore. “Yet the reality is that this is a quick fix. Only a comprehensive political resolution to the conflict can secure the wellbeing of children across the country over the long term.”

“It is unacceptable for people to die from preventable diseases,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “We are grateful for the pause in fighting which enabled us to complete the cholera vaccination campaign. Vaccination is one of many health services people need. Ultimately, peace is the only road to health.”

Since April 2017, there have been over 1.2 million suspected cholera cases and 2,515 associated deaths in the country – one of the worst outbreaks in recent history. The vaccination is critical to preventing further spread of the disease. This campaign aimed to reach 540,000 in the three districts.

Before the end of the year, many more people will need to be vaccinated against cholera, and millions more children immunized against polio, measles, pneumonia and other preventable diseases…

Zimbabwe to vaccinate 1.4 million people against cholera in Harare

3 October 2018, Harare – The Government of Zimbabwe with the support of the World Health Organization (WHO) and partners is launching today an oral cholera vaccination (OCV) campaign to protect 1.4 million people at high risk of cholera in Harare.

The immunization drive is part of efforts to control a cholera outbreak, which was declared by the health authorities on 6 September 2018.The vaccines were sourced from the global stockpile, which is funded by Gavi, the Vaccine Alliance. Gavi is also funding operational costs for the campaign..

The current cholera outbreak is geographically concentrated in the densely populated suburbs of Harare,” said Dr Matshidiso Moeti, WHO’s Regional Director for Africa. “We have a window of opportunity to strike back with the oral cholera vaccine now, which along with other efforts will help keep the current outbreak in check and may prevent it from spreading further into the country and becoming more difficult to control.”

The campaign will be rolled out in two rounds, focusing on the most heavily affected suburbs in Harare and Chitungwiza, which is 30 km southeast of the capital city. To ensure longer-term immunity to the population, a second dose of the vaccine will be provided in all areas during a second round to be implemented at a later stage.

“Cholera is a disease that can be prevented with clean water and sanitation: there is no reason why people should still be dying from this horrific disease,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “Gavi has worked hard to ensure the global cholera vaccine stockpile remains fully stocked and ready to help stop outbreaks such as this. The government of Zimbabwe have done a great job in fighting this outbreak; we must now hope that these lifesaving vaccines can help to prevent any more needless deaths.”

WHO is supporting the Ministry of Health and Child Care on a strategy for rolling out the vaccination campaign, as well as implementing the campaign and sensitizing the public about the vaccine.  More than 600 health workers have been trained to carry out the campaign…

Milestones :: Perspectives
Best-selling author and vaccine expert Dr. Paul Offit to discuss his latest book and the fight against science-deniers, anti-vaxxers and “alternative facts” at National Press Club Headliners Event Oct. 29

Oct 04, 2018, 16:09 ET /PRNewswire/ — Dr. Paul Offit, an award-winning expert on vaccines, immunology and virology and co-inventor of a rotavirus vaccine credited with saving hundreds of lives every day, will appear at a National Press Club Headliners Book Rap on Monday, O::::::

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 25 September 2018 [GPEI]
:: Preparations for World Polio Day are in full swing:  partners and stakeholders across the world are preparing for World Polio Day on 24 October, to raise awareness and resources for the global eradication effort.  Join Rotarians around the world in making this year’s World Polio Day a huge success.  Click here to view a video message by Rotary International President Barry Rassin, inviting everyone to join in World Polio Day activities.

Summary of new viruses this week:
Afghanistan – one case of wild poliovirus type 1 (WPV1) and five WPV1-positive environmental samples;
Pakistan – seven WPV1-positive environmental samples;
Nigeria – three cases of circulating vaccine-derived poliovirus type 2 (cVDPV2);
Horn of Africa (Somalia) – one cVDPV type 3-positive environmental sample
 
::::::
::::::
 
Editor’s Note:
WHO has posted a refreshed emergencies page which presents an updated listing of Grade 3,2,1 emergencies as below.

WHO Grade 3 Emergencies  [to 6 Oct 2018 ]
Democratic Republic of the Congo
:: 09: Situation report on the Ebola outbreak in North Kivu  4 October 2018
:: Disease Outbreak News (DONs)  Ebola virus disease – Democratic Republic of the Congo
4 October 2018
[See Milestones above for detail]

Nigeria
:: Yobe State requests WHO’s expertise over fresh cholera outbreak
Damaturu, 27 September 2018 – The Yobe state Government has called on the World Health Organization (WHO) to deploy its human resources and technical expertise to contain the ongoing outbreak of cholera in the state. The request was contained in a Press statement in Damaturu, the state capital by the Commissioner for Health, Dr Muhammad Bello Kawuwa…

Syrian Arab Republic
:: WHO delivers largest cross-border shipment of health supplies to northwest Syrian Arab Republic to date
5 October 2018 — The World Health Organization (WHO) supported close to 180 health facilities in northwest Syrian Arab Republic in September 2018 with essential medical supplies, totaling over 104 tonnes worth US$ 1.3 million. This is one of the biggest monthly shipments to date this year from its operational hub in Turkey, delivered to prepare for any possible escalation of conflict.
With these supplies, health facilities will be able to provide approximately 677 000 medical treatments for surgery and trauma, communicable and non-communicable diseases, and more. Medical supplies allow health facilities to remain functional and continue providing medical services to both trauma patients and those in need of primary health care…

Yemen – No new announcements identified
[See joint WHO-UNICEF press release above]

Bangladesh – Rohingya crisis – No new announcements identified
Somalia – No new announcements identified
South Sudan – No new announcements identified

::::::
 
WHO Grade 2 Emergencies  [to 6 Oct 2018 ]
Zimbabwe
:: Zimbabwe to vaccinate 1.4 million people against cholera in Harare

3 October 2018, Harare – The Government of Zimbabwe with the support of the World Health Organization (WHO) and partners is launching today an oral cholera vaccination (OCV) campaign to protect 1.4 million people at high risk of cholera in Harare…
[See OCV above for more detail]
 
Iraq
:: Restoring mobility and hope in Mosul   5 October 2018
 
MERS-CoV
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia  3 October 2018
 
Cameroon  – No new announcements identified
Central African Republic  – No new announcements identified
Ethiopia – No new announcements identified
Hurricane Irma and Maria in the Caribbean – No new announcements identified
occupied Palestinian territory – No new announcements identified
Libya – No new announcements identified
Myanmar – No new announcements identified
Niger – No new announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new announcements identified
South Africa Listeriosis (2017) – No new announcements identified
Sudan – No new announcements identified
Ukraine – No new announcements identified

Outbreaks and Emergencies Bulletin, Week 37: 22 -28 September 2018
The WHO Health Emergencies Programme is currently monitoring 54 events in the AFRO region. This week’s edition covers key ongoing events, including:
:: Ebola virus disease outbreak in the Democratic Republic of the Congo
:: Cholera outbreak in Zimbabwe
:: Cholera outbreak in Cameroon
:: Plague outbreak in Madagascar
:: Monkeypox outbreak in Nigeria.
::::::
 
WHO Grade 1 Emergencies  [to 6 Oct 2018 ]
Afghanistan
Angola (in Portuguese)
Chad
Ethiopia
Kenya
Lao People’s Democratic Republic
Mali
Papua New Guinea
Peru
Tanzania
Tropical Cyclone Gira
Zambia
 
::::::

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. 
Yemen
:: Yemen Humanitarian Update Covering 18 – 27 September 2018 | Issue 28

Key Issues
– Food and fuel prices have skyrocketed following a sharp depreciation of the Yemeni Rial against the US dollar. Crippling fuel queues are reported in Sana’a.
– Food security has further deteriorated, which could add another 3.5 million people to the 8.4 million people who currently need emergency food assistance in Yemen.
– The main Al Hudaydah-Sana’a road remains inaccessible due to fighting; access to the city is only from the north, on the Al Hudaydah-Hajjah road.
– Over 2.3 million people have been displaced by conflict since 2015; and an additional 58,000 households were displaced between June and August 2018.
– Efforts are underway to expedite the release of humanitarian cargo currently held at Yemen’s main entry points awaiting import approval.

Syrian Arab Republic   – No new announcements identified.

::::::

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.
Ethiopia 
:: Ethiopia Humanitarian Bulletin Issue 64 | 17 – 30 September 2018
Somalia   
:: Humanitarian Bulletin Somalia, 5 September – 4 October 2018

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

EBOLA/EVD  [to 6 Oct 2018 ]
http://www.who.int/ebola/en/
[See Milestones above for more detail]

MERS-CoV [to 6 Oct 2018 ]
http://who.int/emergencies/mers-cov/en/
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia  3 October 2018

Yellow Fever  [to 6 Oct 2018 ]
http://www.who.int/csr/disease/yellowfev/en/
– No new announcements identified.

Zika virus  [to 6 Oct 2018 ]
http://www.who.int/csr/disease/zika/en/
– No new announcements identified.
 
::::::
::::::
 

WHO & Regional Offices [to 6 Oct 2018 ]
5 October 2018
News Release
Health workers in Yemen reach more than 306,000 people with cholera vaccines during four-day pause in fighting – WHO, UNICEF

1 October 2018
News Release
WHO FCTC opens 8th COP session to review progress, strengthen global fight against tobacco use

1 October 2018
News Release
WHO calls for increased investment to reach the goal of a toilet for all

Commentary
Ending the epidemics of high-impact communicable diseases
Why primary health care matters
1 October 2018

::::::
 
Weekly Epidemiological Record, 5 October 2018, vol. 93, 40 (pp. 521–540)
:: Surveillance of leishmaniasis in the WHO European Region, 2016
:: Global leishmaniasis surveillance update, 1998–2016

::::::
 
October 2018
GIN September 2018  pdf, 2.03Mb
 
::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO

Selected Featured News
:: South Sudan establishes Rota sentinel surveillance to determine the extent of Rotavirus infection among children with acute diahorrea  04 October 2018
:: East African Countries intensify collaboration and Preparedness as Ebola Outbreak Continues in DRC  03 October 2018
:: Zimbabwe to vaccinate 1.4 million people against cholera in Harare  03 October 2018
:: From high burden to high impact: getting back on track to end malaria  29 September 2018

WHO Region of the Americas PAHO
– No new announcement identified
 
WHO South-East Asia Region SEARO
:: Major Earthquake Hits Sulawesi, Indonesia, 28 September 2018
A 7.7 magnitude earthquake hit Donggala District Central Sulawesi, Indonesia on 28 September 2018. A tsunami hit Palu City, the provincial capital of Central Sulawesi, around fifteen minutes after the quake. The twin disaster affected over 500,000 people, damaging homes, leaving 70,000 homeless and causing loss of over 1500 lives.
The Government of Indonesia is spearheading the emergency response with exhaustive search and rescue operations, and healthcare efforts. WHO is closely monitoring the public health needs of the affected while supporting the national authorities in coordination of the health sector response…
 
WHO European Region EURO
:: Healthy cities of the European Region adopt the Belfast Charter, ushering in a new phase of commitment 05-10-2018
:: Changing cities to change the world 03-10-2018

WHO Eastern Mediterranean Region EMRO
– No new announcement identified

WHO Western Pacific Region
– No new announcement identified

CDC/ACIP [to 6 Oct 2018 ]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for October 5, 2018

No new digest content identified.

Africa CDC   [to 6 Oct 2018 ]
https://au.int/en/africacdc

October 02, 2018
Africa CDC Workshop on “One Health” in East Africa Held Today
Addis Ababa, October 1, 2018- The Africa Centers for Disease Control and Prevention (Africa CDC) has held its first workshop on the “ONE HEALTH” (OH) Project at the AU headquarters. The two day workshop is a coordinated effort between the AfricaCDC and Chatham House Centre on Global Health Security. The workshop aims to forge a consortium towards the preparation of a feasibility study to support the enhanced operationalization of OH in Africa, honing in on the East Africa region as a first step. The workshop comprises presentations to introduce the different themes and group work to deliberate and produce inputs towards the preparation of the feasibility plan.

In a statement read on his behalf by Dr Raji Tajudeen, Director of Africa CDC Dr. John Nkengasong assured participants that the workshop will help towards the development of a feasibility study on the integrated operationalization of OH in Africa. “Africa has been suffering from environmental infectious diseases such as rabies, anthrax and fever due to non-existence of proper strategies to tackle the problem, and that is why Africa CDC is leading the way because our core responsibility is to strengthen, protect and control infectious disease”, he noted.

He further stressed that, “Africa cannot achieve this alone, unless we work hand-in-hand with major stakeholders, like the environmental agencies, to see how we can develop strategies to tackle this problem”…

China CDC 
http://www.chinacdc.cn/en/
New website launched…no “news” or “announcements” page identified.

National Health Commission of the People’s Republic of China
http://en.nhfpc.gov.cn/
Selected Updates/Press Releases
No new digest content identified.

Announcements
 
AERAS  [to 6 Oct 2018 ]
http://www.aeras.org/pressreleases
OCTOBER 1, 2018
IAVI Acquires Aeras TB Vaccine Clinical Programs and Assets
The International AIDS Vaccine Initiative (IAVI) and Aeras, a nonprofit organization dedicated to developing tuberculosis (TB) vaccines, today announced the transfer to IAVI of Aeras’ TB vaccine clinical research programs and assets, consisting of certain clinical staff, clinical programs, biorepository, funding commitments, and other assets.
 [See Milestones above for detail]
 
 
 
 
BMGF – Gates Foundation  [to 6 Oct 2018 ]
http://www.gatesfoundation.org/Media-Center/Press-Releases
OCTOBER 04, 2018
Tanganyika Province Affirms Commitment to Strengthening Routine Immunization in Partnership with the Bill & Melinda Gates Foundation
SEATTLE, October 4, 2018 – Today, the honorable Mr. Richard Ngoy Kitangala, governor of Tanganyika Province in the Democratic Republic of the Congo (DRC), and Chris Elias, President, Global Development at the Bill & Melinda Gates Foundation, signed a Memorandum of Understanding (MoU) to improve vaccination coverage among children in Tanganyika Province and thus save people’s lives.
 
 
Bill & Melinda Gates Medical Research Institute    [to 6 Oct 2018 ]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.
 
 
CARB-X   [to 6 Oct 2018 ]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 6 Oct 2018 ]
http://cepi.net/
No new digest content identified.
 
 
EDCTP    [to 6 Oct 2018 ]
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
No new digest content identified.
 
 
Emory Vaccine Center    [to 6 Oct 2018 ]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 6 Oct 2018 ]
http://www.ema.europa.eu/ema/
News and press releases
Boosting the development of medicines for children
News 02/10/2018
The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published today a joint action plan to support the development of medicines for children in Europe

The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Legislation. It also takes into account the ideas on how to better apply the Paediatric Regulation to boost the development of medicines for children collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.
The actions in the plan are clustered around five key areas:
:: identifying paediatric medical needs;
:: strengthening cooperation between decision makers;
:: ensuring timely completion of paediatric investigation plans (PIPs);
:: improving the handling of PIP applications;
:: increasing transparency around paediatric medicines.
It is expected that the implementation of these actions will increase the efficiency of paediatric regulatory processes in the current legal framework and boost the availability of medicines for children…

01/10/2018
Expert meeting on genome editing technologies used in medicine development
European Medicines Agency, London, UK, from 18/10/2017 to 18/10/2017
Genome editing technologies are progressing with an unprecedented speed. Medicinal products developed using these novel technologies may potentially ameliorate or cure genetic diseases. However, they also come with complexities and challenges during their development, manufacture, evaluation and ultimately making them available to patients. This meeting brings together leading academic institutions as well as industry stakeholders with the most advanced development programmes using genome editing to discuss the current state of art, challenges and opportunities linked with genome editing and to present case studies of the most advanced developments.
   Agenda – EMA expert meeting on genome editing technologies used in medicinal product development 
 
 
European Vaccine Initiative  [to 6 Oct 2018 ]
http://www.euvaccine.eu/news-events
No new digest content identified.
 
 
FDA [to 6 Oct 2018 ]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
October 05, 2018
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. ”The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”…

The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition…

Fondation Merieux  [to 6 Oct 2018 ]
http://www.fondation-merieux.org/
Event
Vaccinology 2018: 11th International Symposium for Latin America experts
October 17 – 19, 2018 – Panama
 
 
 
Gavi [to 6 Oct 2018 ]
https://www.gavi.org/
No new digest content identified.
 
 
 
GHIT Fund   [to 6 Oct 2018 ]
https://www.ghitfund.org/newsroom/press
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
No new digest content identified.
 
 
Global Fund [to 6 Oct 2018 ]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
No new digest content identified.
 
 
Hilleman Laboratories   [to 6 Oct 2018 ]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 6 Oct 2018 ]
http://www.humanvaccinesproject.org/media/press-releases/
Event
Towards a Universal Influenza Vaccine: Lessons from the Great Influenza Pandemic of 1918 to Now
November 15-16, 2018 I Nashville, TN
The Human Vaccines Project is hosting a scientific summit featuring prominent researchers and thought leaders to discuss cutting-edge influenza research. The 2-day meeting will bring together leading scientists, clinicians and public health specialists including: John Barry, James E. Crowe, Jr., Senator Bill Frist, and Laurie Garrett.  Find a full agenda at:
www.humanvaccinesproject.org/talks/universalinfluenzavaccinesummit
 
 
IAVI  [to 6 Oct 2018 ]
https://www.iavi.org/
No new digest content identified.
 
 
IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.
 
 
IVAC  [to 6 Oct 2018 ]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 
 
IVI   [to 6 Oct 2018 ]
http://www.ivi.int/
No new digest content identified.
 
 
 JEE Alliance  [to 6 Oct 2018 ]
https://www.jeealliance.org/
No new digest content identified. 
 
 
MSF/Médecins Sans Frontières  [to 6 Oct 2018 ]
http://www.msf.org/
Selected Press Releases/Statements
South Sudan
MSF resumes medical activities in Maban after suspension
Project Update 5 Oct 2018
South Sudan
Helping Yambio’s demobilised child soldiers come to terms…
Project Update 5 Oct 2018
Yemen
MSF suspends activities after attack in Ad Dhale
Statement 2 Oct 2018
Rohingya refugee crisis
Crisis update – September 2018
Crisis Update 1 Oct 2018
 
 
 
NIH  [to 6 Oct 2018 ]
http://www.nih.gov/news-events/news-releases
October 1, 2018
NIH-led task force submits recommendations on research needs for pregnant women and nursing mothers
— Group reviewed current research and focused on specific drugs, formulations and other pharmacological factors that may affect health outcomes for pregnant women and nursing mothers.
NIH grantee wins 2018 Nobel Prize in Physiology or Medicine
October 1, 2018 — The 2018 Nobel Prize in Physiology or Medicine has been awarded to NIH grantee James P. Allison, Ph.D., of the University of Texas, M.D. Anderson Cancer Center, Houston, Texas.

 
 
PATH  [to 6 Oct 2018 ]
https://www.path.org/media-center/
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 6 Oct 2018 ]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
 UNAIDS [to 6 Oct 2018 ]
http://www.unaids.org/en
News   1 October 2018
UNAIDS joins United Nations and world leaders to stand together against sexual exploitation and abuse
 
 
UNICEF  [to 6 Oct 2018 ]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Press release
UNICEF supports Indonesian authorities in identifying unaccompanied and separated children in areas affected by earthquake and tsunami in Indonesia
05/10/2018
Press release
Health workers in Yemen reach more than 306,000 people with cholera vaccines during four-day pause in fighting – WHO, UNICEF
Vaccination campaign covers war-torn areas of Hudaydah and Ibb
05/10/2018
Press release
UNICEF is concerned for safety of thousands of children in Indonesia following Sulawesi earthquake and tsunami
 
 
Vaccine Confidence Project  [to 6 Oct 2018 ]
http://www.vaccineconfidence.org/
No new digest content identified.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 6 Oct 2018 ]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
Wellcome Trust  [to 6 Oct 2018 ]
https://wellcome.ac.uk/news
News / Published: 6 October 2018
Sir Roger Gibbs, 1934-2018
It was with great sadness that we learned yesterday that Sir Roger Gibbs has died. Sir Roger was the Chairman of Wellcome from 1989 to 1999, overseeing perhaps the biggest transformation in our history and laying the foundations for what Wellcome has become today.

News / Published: 4 October 2018
The quest to know everything: 25 years of the Sanger Institute
Since 1993, the Wellcome Sanger Institute has been uncovering the secrets of life through its ground-breaking genomics projects. In this special feature to mark its first 25 years, Rob Reddick explores how its unique work is changing the world.

Opinion / Published: 3 October 2018
Used effectively, your research can improve policy and practice
In this blog I’m focusing on using knowledge effectively, the third pillar of Wellcome’s Science strategy. The first pillar concerns knowledge creation, but the appropriate use of that knowledge to improve health is fundamental to what we’re trying to achieve.
 
 
The Wistar Institute   [to 6 Oct 2018 ]
https://www.wistar.org/news/press-releases
Press Release
Oct. 4, 2018
Engineered Synthetic DNA-Encoded Checkpoint Inhibitor Antibodies Advance the Field of Cancer Immunotherapy
This novel approach opens new avenues of research and may expand clinical approaches for cancer immunotherapy.
 
 
World Organisation for Animal Health (OIE)   [to 6 Oct 2018 ]
http://www.oie.int/en/for-the-media/press-releases/2018/
04/10/18
Launch of the OIE Rinderpest Challenge
What would happen if the rinderpest virus, the only animal disease eradicated in the world, returns from the past threatening animal health security globally? The World Organisation for Animal Health (OIE) launches today the Rinderpest Game with a global Challenge on its dedicated website: www.rinderpestvigilance.com. From 4 October to 1 November 2018 players are invited to find the source of the rinderpest outbreak and save the world!

::::::
 
BIO    [to 6 Oct 2018 ]
https://www.bio.org/insights/press-release
No new digest content identified.
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 6 Oct 2018 ]
http://www.dcvmn.org/
No new digest content identified.
 
IFPMA   [to 6 Oct 2018 ]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.
 
 
PhRMA    [to 6 Oct 2018 ]
http://www.phrma.org/press-room
October 3, 2018
PhRMA Statement on the United States-Mexico-Canada Agreement
“The United States-Mexico-Canada Agreement marks a historic point for U.S. trade policy, cementing critical intellectual property (IP) protections and other standards that will pave the way for the next generation of treatments and cures.

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

No new digest content identified.

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

BMJ Global Health
October 2018 – Volume 3 – 5
https://gh.bmj.com/content/3/5
Editorial

Towards equity in global health partnerships: adoption of the Research Fairness Initiative (RFI) by Portuguese-speaking countries (10 September, 2018)
António Carvalho, Carel IJsselmuiden, Kirsty Kaiser, Zulmira Hartz, Paulo Ferrinho

BMJ Global Health
October 2018 – Volume 3 – 5
https://gh.bmj.com/content/3/5

Research
Pushing the envelope through the Global Financing Facility: potential impact of mobilizing additional support to scale-up life-saving interventions for women, children and adolescents in 50 high-burden countries (2 October, 2018)
Victoria B. Chou, Oliver Bubb-Humfryes, Rachel Sanders, Neff Walker, John Stover, Tom Cochrane, Angela Stegmuller, Sophia Magalona, Christian Von Drehle, Damian G. Walker, Maria Eugenia Bonilla-Chacin, Kimberly Rachel Boer

BMJ Global Health
October 2018 – Volume 3 – 5
https://gh.bmj.com/content/3/5

Practice
Data for decision making: using a dashboard to strengthen routine immunisation in Nigeria (2 October, 2018)
Sulaiman Etamesor, Chibuzo Ottih, Ismail Ndalami Salihu, Arnold Ikedichi Okpani

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 6 Oct 2018 )

Research article
|   4 October 2018
Impact of the 10-valent pneumococcal conjugate vaccine on antimicrobial prescriptions in young children: a whole population study
Authors: Elias Eythorsson, Samuel Sigurdsson, Birgir Hrafnkelsson, Helga Erlendsdóttir, Ásgeir Haraldsson and Karl G Kristinsson

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 6 Oct 2018 )

Research article
|   4 October 2018
The landscape of vaccines in China: history, classification, supply, and price
Authors: Yaming Zheng, Lance Rodewald, Juan Yang, Ying Qin, Mingfan Pang, Luzhao Feng and Hongjie Yu
Abstract
Background
Vaccine regulation in China meets World Health Organization standards, but China’s vaccine industry and immunization program have some characteristics that differ from other countries. We described the history, classification, supply and prices of vaccines available and used in China, compared with high-and middle-incomes countries to illustrate the development of Chinese vaccine industry and immunization program.
Methods
Immunization policy documents were obtained from the State Council and the National Health and Family Planning Commission (NHFPC). Numbers of doses of vaccines released in China were obtained from the Biologicals Lot Release Program of the National Institutes for Food and Drug Control (NIFDC). Vaccine prices were obtained from Chinese Central Government Procurement (CCGP). International data were collected from US CDC, Public Health England, European CDC, WHO, and UNICEF.
Results
Between 2007 and 2015, the annual supply of vaccines in China ranged between 666 million and 1,190 million doses, with most doses produced domestically. The government’s Expanded Program on Immunization (EPI) prevents 12 vaccine preventable diseases (VPD) through routine immunization. China produces vaccines that are in common use globally; however, the number of routinely-prevented diseases is fewer than in high- and middle-income countries. Contract prices for program (EPI) vaccines ranged from 0.1 to 5.7 US dollars per dose – similar to UNICEF prices. Contract prices for private-market vaccines ranged from 2.4 to 102.9 US dollars per dose – often higher than prices for comparable US, European, and UNICEF vaccines.
Conclusion
China is a well-regulated producer of vaccines, but some vaccines that are important globally are not included in China’s EPI system in China. Sustained and coordinated effort will be required to bring Chinese vaccine industry and EPI into an era of global leadership.

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 6 Oct 2018 )

Research article
Projecting the end of the Zika virus epidemic in Latin America: a modelling analysis
Zika virus (ZIKV) emerged in Latin America and the Caribbean (LAC) region in 2013, with serious implications for population health in the region. In 2016, the World Health Organization declared the ZIKV outbre…
Authors: Kathleen M. O’Reilly, Rachel Lowe, W. John Edmunds, Philippe Mayaud, Adam Kucharski, Rosalind M. Eggo, Sebastian Funk, Deepit Bhatia, Kamran Khan, Moritz U. G. Kraemer, Annelies Wilder-Smith, Laura C. Rodrigues, Patricia Brasil, Eduardo Massad, Thomas Jaenisch, Simon Cauchemez…
Citation: BMC Medicine 2018 16:180
Published on: 3 October 2018