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
Police to help hospitals reduce patient disputes
2018-09-27
Public security departments will improve cooperation with health authorities to reduce medical disputes between patients and hospitals, Li Jingsheng, chief of security administration at the Ministry of Public Security, said at a conference on Sept 26 with several departments.

Chinese first lady calls for global efforts against TB
2018-09-27
Peng Liyuan, wife of Chinese President Xi Jinping, addressed the United Nations General Assembly high-level meeting on ending tuberculosis (TB) via a video on Sept 26, calling for global efforts to put an end to the epidemic.

Abortions in China decreased in past five years
2018-09-26
The number of abortions in China has decreased in the past five years, but the high proportion of young adults and teenagers undergoing the procedure remains a vexing issue.

Chinese doctors to provide free eye surgeries in 6 countries
2018-09-25
China has announced plans to send medical teams to provide free surgery to 3,000 cataract patients in six countries involved in the Belt and Road Initiative in the next three years.

China to become world’s largest country of organ transplants in 2020
2018-09-25
China is expected to have the most organ transplant surgeries in 2020, said Huang Jiefu, director of the China National Organ Donation and Transplantation Committee.
 
 

Announcements
 
 
AERAS  [to 29 Sep 2018]
http://www.aeras.org/pressreleases
25 September 2018
GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults in phase II study
Today, GSK and Aeras reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection in ongoing phase IIb clinical trial testing.
[See Milestones above for detail]
 
 
BMGF – Gates Foundation  [to 29 Sep 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 29 Sep 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 29 Sep 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.
09.24.2018  |
CARB-X calls for new ‘open science’ era in antibacterial innovation: Sharing scientific data will help speed the delivery of new antibiotics and other life-saving products to fight superbugs
Achaogen will share valuable LpxC compounds and data with Forge Therapeutics, with both companies leading the ‘open science’ initiative among CARB-X-funded companies
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 29 Sep 2018]
http://cepi.net/
Posted on 27TH SEP 2018 by Mario Christodoulou
CEPI Awards Contract Worth Up To USD$19 million to Oxford University and Janssen Vaccines to Develop MERS, Lassa, and Nipah Vaccines
OSLO (Norway), Oxford (UK)
CEPI (the Coalition for Epidemic Preparedness Innovations) today announced a collaboration with The Jenner Institute at the University of Oxford and Janssen Vaccines & Prevention B.V.—part of the Janssen Pharmaceutical Companies of Johnson & Johnson—through which they will receive funding to advance the development and manufacture of a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Preclinical development of novel vaccines against Lassa and Nipah viruses will also be undertaken as part of this collaboration.
Oxford has already initiated clinical development of the MERS-CoV vaccine, with funding from the UK Department of Health and Social Care, and a phase 1 clinical trial of the vaccine is underway in the UK. Under the terms of the Framework Partnering Agreement for the collaboration, Oxford and Janssen will receive $14.6 million from CEPI to support manufacturing of a phase 2 batch and preparation for stockpiling of a MERS-CoV vaccine candidate. Dependent on phase 1 results, CEPI will have the option to provide additional investment for a phase 2 trial and manufacture of an investigational vaccine stockpile that would be available for use in the event of an outbreak. Janssen’s proprietary vaccine-manufacturing platform will enable rapid and efficient production of large volumes of vaccines. Should CEPI exercise its option to provide support for further clinical development, Oxford will undertake phase 2 testing of the vaccine, in partnership with the King Abdullah International Medical Research Centre (KAIMRC) in Riyadh, Kingdom of Saudi Arabia, and the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme at Kilifi, Kenya.
As part of the collaboration, CEPI will also provide funding of up to $2.1 million to support the preclinical development of a Lassa vaccine and up to $2.0 million to support the preclinical development of a Nipah vaccine…
 
 
EDCTP    [to 29 Sep 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
28 September 2018
EDCTP Prizes 2018 awarded at Ninth Forum
EDCTP awarded its 2018 prizes for research excellence and the Pascoal Mocumbi Prize at the opening ceremony of the Ninth Forum on Monday 17 September. Dr Leonardo Simão and Prof. Marcel Tanner, the EDCTP High Representatives for Africa and Europe, presented…
 
 
27 September 2018
EDCTP-funded R&D partnerships to tackle infectious disease in Sub-Saharan Africa, 2003-2018
On 17 September 2018 at the High-Level Meeting to discuss a third EDCTP programme in Lisbon, Portugal, Dr Michael Makanga, EDCTP’s Executive Director, presented a collection of success stories illustrating EDCTP’s contribution to the fight against poverty-related infectious diseases over…
 
 
Emory Vaccine Center    [to 29 Sep 2018]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 29 Sep 2018]
http://www.ema.europa.eu/ema/
News and press releases

27/09/2018
Harnessing the potential of real world data through a ‘learning healthcare system’
Real world data (RWD) hold the promise to substantially increase the effectiveness and efficiency of all processes in the development and utilisation of medicines, from research and development, to regulatory decision-making, pricing and reimbursement decisions to use in medical practice. However, to realise the full potential of RWD requires a ‘learning healthcare system’, write the European Medicines Agency’s (EMA) Executive Director and Senior Medical Officer, as well as heads of three national EU agencies, and academia, payer, and Organisation for Economic Co-operation and Development (OECD) representatives, in a paper published in Clinical Pharmacology and Therapeutics.

A ‘learning healthcare system’, based on electronic health records and other routinely collected healthcare data, would allow RWD to be continuously fed into the system, ensuring that with every new patient treated, we know more overall about the practice of medicine.

Such judicious use of RWD would complement the traditional evidence from randomised clinical trials, for  the benefit of all stakeholders involved in the development and use of medicines, from patients and healthcare professionals to regulators, health-technology assessment bodies, payers, academic researchers and research-based pharmaceutical industry. The authors highlight the need to tear down the current barrier between the structured research setting and everyday medical practice, and instead use data gathered in everyday practice to generate new knowledge and answer research questions.

To achieve this, the healthcare systems must be ready in terms of technology to collect data, of a methodology to analyse information and governance in particular regarding aspects such as protection of personal data, consent, ethics and data access.
The authors therefore call for all stakeholders to join in a coordinated effort, at international level, to accelerate the implementation of such a model of a ‘learning healthcare system’.

Publications
Clinical Pharmacology and Therapeutics: Data rich, information poor; can we use electronic health records to create a learning healthcare system for pharmaceuticals?

25/09/2018
EMA to launch new corporate website on 27 September 2018
 
 
European Vaccine Initiative  [to 29 Sep 2018]
http://www.euvaccine.eu/news-events
25 September 2018
EVI Annual Report 2017 now available
We are pleased to share with you the EVI Annual Report 2017.
 
 
FDA [to 29 Sep 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
September 28, 2018
FDA in Brief: FDA modernizes clinical trial designs and approaches for drug development, proposing new guidance on the use of adaptive designs and master protocols
[See Milestones above for detail]

September 27, 2018 –
Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations
 
September 24, 2018 –
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country…
   The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program. This program is funded by Congressional appropriations and encourages clinical development of drugs, biologics, medical devices or medical foods for use in rare diseases. The grants are intended for clinical studies evaluating the safety and effectiveness of products that could either result in, or substantially contribute to, the FDA approval of products targeted to the treatment of rare diseases. Grant applications were reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts, which included representatives from academia, the National Institutes of Health and the FDA…
 
 
Fondation Merieux  [to 29 Sep 2018]
http://www.fondation-merieux.org/
No new digest content identified.
 
 
Gavi [to 29 Sep 2018]
https://www.gavi.org/
28 September 2018
UBA Foundation and Gavi launch a new partnership for Africa
The UBA Foundation and Gavi will leverage the United Bank for Africa’s network and expertise to invest in Africa’s health system, starting with Nigeria.
 
Why hepatitis B vaccination should be Plan A in the fight against liver cancer
27 September 2018
 
Gavi at the UNGA: driving political leadership
27 September 2018
 
 
GHIT Fund   [to 29 Sep 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
September 27, 2018
GHIT Fund Invests in FIND and Fujifilm for Development of Innovative Rapid Diagnostic Tool for Tuberculosis.
TOKYO, JAPAN (September 27, 2018)—The Global Health Innovative Technology (GHIT) Fund announced today an investment of approximately 420 million yen (US$3.8 million) for a highly sensitive rapid diagnostic kit for tuberculosis (TB) known as TB-LAM, being developed by Japan’s Fujifilm Corporation and Switzerland’s Foundation for Innovative New Diagnostics (FIND)…

Global Fund [to 29 Sep 2018]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund Supports Brave Commitments to Ending TB
26 September 2018
The Global Fund is joining leaders who converge in New York today to commit to speeding up global collaboration in the fight against TB, a preventable disease that killed 1.6 million people in 2017.
 
 
Hilleman Laboratories   [to 29 Sep 2018]
http://www.hillemanlabs.org/
11/09/2018
Hilleman Labs announces publication of original research on Heat Stable Rotavirus Vaccines
Hilleman Laboratories today announced the publication of original research as well as expert commentary on development of Heat Stable Rotavirus Vaccine (HSRV).
 
 
Human Vaccines Project   [to 29 Sep 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 29 Sep 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 29 Sep 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 
 
IVI   [to 29 Sep 2018]
http://www.ivi.int/
No new digest content identified.
 
 
JEE Alliance  [to 29 Sep 2018]
https://www.jeealliance.org/
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 29 Sep 2018]
http://www.msf.org/
Selected Press Releases/Statements
Niger
One of the world’s biggest paediatric intensive care units is full
Press Release 25 Sep 2018
:: Magaria hospital is the only health facility available in a region of 700,000 to one million people, around 20 per cent of whom are aged under five
:: Of the 730 children currently admitted, 208 are critically ill and mortality rates remain alarmingly high
:: It’s likely that hundreds more children are seriously ill in the community and not getting the care they need

Tuberculosis
Global leaders must make bold commitments at first-ever UN tuberculosis summit
Press Release 25 Sep 2018
:: World leaders are meeting in New York this week for the first-ever high-level summit on tuberculosis
:: TB is the world’s deadliest infectious disease, killing 1.6 million in 2017, but is drastically under-funded
:: MSF implores leaders at the summit to urgently scale up TB diagnosis and treatment, and commit more resources

 
NIH  [to 29 Sep 2018]
http://www.nih.gov/news-events/news-releases
September 26, 2018
Combination HIV antibody infusions safely maintain viral suppression in select individuals
— HIV did not develop resistance to experimental treatment.

NIH releases strategic plan to address tuberculosis research
September 26, 2018 — TB is the leading infectious cause of death worldwide.
[See Milestones above for detail]

NIH-funded genome centers to accelerate precision medicine discoveries
September 25, 2018 — Part of the All of Us Research Program, centers will sequence 1 million genomes.
The All of Us Research Program awarded funds totaling $28.6 million to establish three genome centers around the country. These centers will begin to generate genomic data from biosamples contributed by the program’s participants. Ultimately, this information will become a critical component in the program’s precision medicine research platform, a national resource to support studies on a variety of important health questions. The All of Us Research Program is part of the National Institutes of Health…
The new All of Us Research Program Genome Centers will be led by:
:: Baylor College of Medicine, Houston, with Johns Hopkins University, Baltimore, and The University of Texas Health Science Center at Houston (UTHealth)
:: The Broad Institute, Cambridge, Massachusetts, with Color, Burlingame, California, and the Laboratory for Molecular Medicine at Partners HealthCare, Cambridge, Massachusetts
:: Northwest Genomics Center at the University of Washington, Seattle..

 
PATH  [to 29 Sep 2018]
https://www.path.org/media-center/
Sept. 27, 2018
Global rotavirus vaccine options expand with World Health Organization prequalification of new vaccine from India
Thermostable rotavirus vaccine ROTASIIL® now available for procurement by UN and Gavi
SEATTLE, PATH welcomes the World Health Organization’s (WHO’s) prequalification of the thermostable rotavirus vaccine, ROTASIIL®, manufactured by Serum Institute of India. The vaccine, which prevents severe rotavirus-induced diarrhea in infants, provides an innovative and affordable option to the global market as it is the first rotavirus vaccine that does not require constant refrigeration and will help meet the critical public health goal of improving vaccine supply worldwide…

September 25, 2018 by PATH
Vietnam welcomes two locally produced vaccines for seasonal and pandemic influenza
International collaboration announces successful clinical trial results with licensure expected in 2019
Nha Trang, Vietnam, September 25, 2018—The Institute of Vaccines and Medical Biologicals (IVAC), World Health Organization (WHO), international global health organization PATH, and the Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services, today joined leaders from the Ministry of Health (MOH), the National Institute of Hygiene and Epidemiology (NIHE), and the Pasteur Institute in Ho Chi Minh City (PIHCM) to announce results from two different Phase 2/3 clinical trials of locally produced seasonal and pandemic influenza vaccine candidates. Overall results showed both vaccine candidates to be acceptably safe and capable of prompting an immune response in healthy adults…

Sabin Vaccine Institute  [to 29 Sep 2018]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
UNAIDS [to 29 Sep 2018]
http://www.unaids.org/en
News
28 September 2018
Building faith-based partnerships to end AIDS and TB among children and adolescents
 
PEPFAR: the first 15 years
 
27 September 2018
Learning lessons from the AIDS response to control NCDs
 
26 September 2018
An opportunity to end two of the world’s deadliest infectious diseases: TB and HIV
 
Uniting for every woman and every child
 
25 September 2018
First ladies of Africa working to stop new HIV infections among children

UNICEF  [to 29 Sep 2018]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Press release
UNICEF teams up with Ebola survivors to help stop spread of deadly outbreak in the Democratic Republic of the Congo
28/09/2018
[See Milestones above for detail]

Press release
Remarks by Henrietta H. Fore, UNICEF Executive Director at the High-Level Meeting on Tuberculosis
As prepared for delivery
26/09/2018
[See Milestones above for detail]

Press release
New roadmap to prevent and treat tuberculosis in children and adolescents
In 2017, almost one million children fell ill and over 200,000 children under 15 died of tuberculosis
[See Milestones above for detail]

Vaccine Confidence Project  [to 29 Sep 2018]
http://www.vaccineconfidence.org/
No new digest content identified.
 

Vaccine Education Center – Children’s Hospital of Philadelphia  [to 29 Sep 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
September 2018
Vaccine Update for Providers
This newsletter is meant to keep you up to date on issues related to vaccines quickly and easily.
 
 
Wellcome Trust  [to 29 Sep 2018]
https://wellcome.ac.uk/news
Published: 27 September 2018
Collaboration was key to success in latest Public Engagement Fund awards
In August, we made the second set of awards under our new Public Engagement Fund scheme. Greer Roberts and Alexandra Parsons pull out some patterns we saw in the applications and have tips for future applicants.

Opinion / Published: 27 September 2018
This is TB’s moment and it must be seized
Two scientific breakthroughs and a global meeting on tuberculosis mean there is an opportunity to move TB from the doldrums, says Wellcome’s Director Jeremy Farrar. But great science needs to be matched by greater global commitment, ambition and political will.
… But now, thanks to the prodigious efforts of two international research teams, two critical milestones have been reached:
:: results of promising clinical trials of a new candidate vaccine (opens in a new tab)
:: a major study sequencing 10,000 TB genomes (opens in a new tab) from patients across 16 countries – work key to the rapid drug sensitivity testing needed to stop the rise and spread of drug-resistant strains of TB…
 
 
The Wistar Institute   [to 29 Sep 2018]
https://www.wistar.org/news/press-releases
Press Release
Virion Therapeutics, LLC Raises $5 Million to Develop Checkpoint Inhibitor Powered Vaccine Therapies for Treatment of Virally Induced Infectious Diseases & Cancers
PHILADELPHIA — (Sept. 26, 2018) — A new Philadelphia-based start-up, Virion Therapeutics, LLC spun out of The Wistar Institute, will work to advance innovative, immune-based therapies for the treatment of chronic viral-associated cancers and viral infections utilizing the first genetically encoded checkpoint inhibitor that can be given via vaccination. Virion is co-founded by Hildegund C.J. Ertl, M.D., professor in the Vaccine & Immunotherapy Center at Wistar, along with life science entrepreneurs Andrew D. Luber, Pharm.D., and Bernard Rudnick, MBA…

World Organisation for Animal Health (OIE)   [to 29 Sep 2018]
http://www.oie.int/en/for-the-media/press-releases/2018/
28/09/18
The United Against Rabies collaboration builds skills and knowledge in rabies-endemic countries towards achievement of zero human rabies deaths
On the occasion of the 12th World Rabies Day, the United Against Rabies collaboration highlights the critical role that intersectoral collaboration must play if the world is to be rid of human rabies deaths by 2030.
Paris/Geneva/Rome/Manhattan, 28 September 2018 – The United Against Rabies collaboration, consisting of the World Health Organization (WHO), World Organisation for Animal Health (OIE), Food and Agriculture Organization of the United Nations (FAO), and Global Alliance for Rabies Control (GARC), has been taking action following the launch in June of Zero by 30: the global strategic plan to end human deaths from dog-mediated rabies by 2030. The plan provides a phased, all-inclusive, intersectoral approach to eliminate human deaths from dog-mediated rabies by 2030. It leverages the work of the four aforementioned organizations to facilitate coordination across the institutions. Its aim is to offer an integrated response to country needs through empowering, engaging and enabling them to lead and strengthen elimination efforts.  The approach limits duplication and improves efficiencies…

::::::
 
BIO    [to 29 Sep 2018]
https://www.bio.org/insights/press-release
No new digest content identified.
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 29 Sep 2018]
http://www.dcvmn.org/
27 September 2018
DCVMN engaged in open dialogue with ICDRA about challenges and opportunities for alignment of procedures for vaccine registration
Dublin, September 4th 2018 – The organizers of the International Conference of Drug Regulatory Authorities (ICDRA) [1] 2018 invited the DCVMN regulatory expert working group to join the pre-ICDRA session on “Enabling access to innovative medical products in resource-limited settings” and present the recently published study, conducted in collaboration with IFPMA [2], on the challenges for the registration of vaccines in emerging countries [3]. A DCVMN representative, Ms. Iin Susanti, delivered the lecture and participated in a panel discussion, elaborating on opportunities and future options for regulatory convergence in addressing the challenges, while respecting regulatory requirements…

 
IFPMA   [to 29 Sep 2018]
http://www.ifpma.org/resources/news-releases/
27 September 2018
The R&D-based biopharmaceutical industry welcomes the UN Declaration on NCDs and calls for innovative financing
As an official UN interlocutor that shares knowledge and expertise to improve global health, IFPMA welcomes the strong re-affirmation of the commitment of governments to take steps to reduce premature mortality from chronic diseases by 2030 and strongly supports the declaration’s emphasis on orienting health systems towards the achievement of universal health coverage (UHC)…

R&D-based biopharmaceutical industry welcomes UN Declaration on TB Partnerships are key to foster innovation and
26 September 2018
The R&D-based biopharmaceutical industry welcomes the political declaration and reaffirms its commitment to the global fight against TB. To deliver on our common goal, industry stands ready to partner on the three pillars of the WHO End TB Strategy including integrated, patient-centred care and prevention; bold policies and supportive systems; and, in particular, intensified research and innovation…

WIPO and IFPMA Launch New Online Patent-Search Resource to Help Health Agencies Procure Medicines
GENEVA, September 25, 2018 – WIPO and the research-based pharmaceutical industry today launched a new online tool designed to help procurement agencies better understand the global patent status of medicines.
The Patent Information Initiative for Medicines (Pat-INFORMED) is a unique resource where patent holders provide information about patents covering approved medicines through a free, open access database.
This new public database became operational today, along with a platform where procurement agencies can make direct enquiries to companies.
Pat-INFORMED is a partnership between WIPO and the International Federation of Pharmaceutical Manufacturers and Associations, IFPMA, the global trade association representing the research-based pharmaceutical industry. Pat-INFORMED originated in the industry’s efforts to add clarity to patent information about medicines. WIPO’s globally recognized expertise in the organization and public dissemination of patent data will make an important contribution to the accessibility of patent information.
WIPO is hosting the database and providing the resources to ensure its continued development, while IFPMA is working closely with the 20 leading research-based biopharmaceutical companies that have backed this initiative to help ensure a consistent and coordinated approach…
 
 
PhRMA    [to 29 Sep 2018]
http://www.phrma.org/press-room
No new digest content identified.

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

American Journal of Infection Control
October 2018 Volume 46, Issue 10, p1083-1200, e45-e50
http://www.ajicjournal.org/current

Major Articles
Enacting high reliability principles while caring for people with Ebola Virus Disease
Bonnie Mowinski Jennings, Katherine A. Yeager, Nancye R. Feistritzer, Mary M. Gullatte, Kristy K. Martyn
p1167–1173  Published online: May 18, 2018
Highlights
:: Infection prevention and control (IPC) are safety issues for patients and staff.
:: A culture of safety was established by enacting high reliability (HR) principles.
:: HR principles helped protect staff caring for patients with Ebola Virus Disease.
:: HR principles might also enhance IPC under ordinary care conditions.

American Journal of Preventive Medicine
October 2018 Volume 55, Issue 4, p433-582
http://www.ajpmonline.org/current

Research Articles
Promoting Adult Immunization Using Population-Based Data for a Composite Measure
Angela K. Shen, Walter W. Williams, Alissa C. O’Halloran, Amy V. Groom, Peng-Jun Lu, Alice Y. Tsai, Megan C. Lindley
p517–523
Published online: August 19, 2018

American Journal of Public Health
October 2018  108(10)
http://ajph.aphapublications.org/toc/ajph/current

AJPH BOOK & MEDIA
The World Health Organization’s Momentous Struggle to Respond to the AIDS Pandemic
Global Health, HIV/AIDS
Matthew M. Kavanagh and Lawrence O. Gostin
108(10), pp. 1272–1273

American Journal of Public Health
October 2018  108(10)
http://ajph.aphapublications.org/toc/ajph/current

AJPH PERSPECTIVES
EBOLA
Ebola Virus Disease Preparations Do Not Protect the United States Against Other Infectious Outbreaks
Health Financing, Infections, Health Policy
Shawn G. Gibbs, John J. Lowe, Aurora B. Le, Jocelyn J. Herstein and Paul D. Biddinger
108(10), pp. 1327–1329

American Journal of Public Health
October 2018  108(10)
http://ajph.aphapublications.org/toc/ajph/current

AJPH LAW & ETHICS
BELMONT REPORT
The Belmont Report at 40: Reckoning With Time
History, Human Rights, Social Science, Ethics
Eli Y. Adashi, LeRoy B. Walters and Jerry A. Menikoff
108(10), pp. 1345–1348
 

American Journal of Public Health
October 2018  108(10)
http://ajph.aphapublications.org/toc/ajph/current

TWITTER
Weaponized Health Communication: Twitter Bots and Russian Trolls Amplify the Vaccine Debate
Media, Immunization/Vaccines
David A. Broniatowski, Amelia M. Jamison, SiHua Qi, Lulwah AlKulaib, Tao Chen, Adrian Benton, Sandra C. Quinn and Mark Dredze
108(10), pp. 1378–1384

American Journal of Public Health
October 2018  108(10)
http://ajph.aphapublications.org/toc/ajph/current

TWITTER
Weaponized Health Communication: Twitter Bots and Russian Trolls Amplify the Vaccine Debate
Media, Immunization/Vaccines
David A. Broniatowski, Amelia M. Jamison, SiHua Qi, Lulwah AlKulaib, Tao Chen, Adrian Benton, Sandra C. Quinn and Mark Dredze
108(10), pp. 1378–1384

American Journal of Public Health
October 2018  108(10)
http://ajph.aphapublications.org/toc/ajph/current

HUMAN PAPILLOMAVIRUES
Human Papillomavirus Vaccine Initiation for Adolescents Following Rhode Island’s School-Entry Requirement, 2010–2016
Immunization/Vaccines, Prevention, Child and Adolescent Health, Adolescent Health, Health Policy, School Health, Gender
Erika L. Thompson, Melvin D. Livingston III, Ellen M. Daley and Gregory D. Zimet
108(10), pp. 1421–1423

American Journal of Tropical Medicine and Hygiene
Volume 99, Issue 2, 2018
http://www.ajtmh.org/content/journals/14761645/99/1

In Memoriam
Ruth Nussenzweig (1928–2018) Malaria Vaccine and Immunology Pioneer
Stephen L. Hoffman
https://doi.org/10.4269/ajtmh.18-1928
 

American Journal of Tropical Medicine and Hygiene
Volume 99, Issue 2, 2018
http://www.ajtmh.org/content/journals/14761645/99/1

Dr. Adel A. F. Mahmoud
Stephanie James, James W. Kazura and Daniel Colley
https://doi.org/10.4269/ajtmh.18-1941

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 29 Sep 2018)

Research article
What is a research derived actionable tool, and what factors should be considered in their development? A Delphi study
Research findings should be disseminated appropriately to generate maximum impact. The development of research derived ‘actionable’ tools (RDAT) as research outputs may contribute to impact in health services and health systems research. However there is little agreement on what is meant by actionable tool or what can make them useful. We set out to develop a consensus definition of what is meant by a RDAT and to identify characteristics of a RDAT that would support its use across the research-practice boundary.
Authors: Susan Hampshaw, Jo Cooke and Laurie Mott
Citation: BMC Health Services Research 2018 18:740
Published on: 27 September 2018

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 29 Sep 2018)

Research article
Assessing the impact of antiretroviral therapy on tuberculosis notification rates among people with HIV: a descriptive analysis of 23 countries in sub-Saharan Africa, 2010–2015
HIV is a major driver of the tuberculosis epidemic in sub-Saharan Africa. The population-level impact of antiretroviral therapy (ART) scale-up on tuberculosis rates in this region has not been well studied.
Authors: Diya Surie, Martien W. Borgdorff, Kevin P. Cain, Eleanor S. Click, Kevin M. DeCock and Courtney M. Yuen
Citation: BMC Infectious Diseases 2018 18:481

Published on: 26 September 2018

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 29 Sep 2018)

Correspondence
Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability
Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sha…
Authors: Ashley M. Hopkins, Andrew Rowland and Michael J. Sorich
Citation: BMC Medicine 2018 16:165
Published on: 28 September 2018

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 29 Sep 2018)

Research article
Quantifying the impact of social groups and vaccination on inequalities in infectious diseases using a mathematical model
Social and cultural disparities in infectious disease burden are caused by systematic differences between communities. Some differences have a direct and proportional impact on disease burden, such as health-s…
Authors: James D. Munday, Albert Jan van Hoek, W. John Edmunds and Katherine E. Atkins
Citation: BMC Medicine 2018 16:162
Published on: 26 September 2018

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 29 Sep 2018)

Research article
Public health response to large influx of asylum seekers: implementation and timing of infectious disease screening
Infectious disease screening of migrants at increased risk is a feature of national infection prevention and control measures. Asylum seekers in Finland are offered screening of tuberculosis (TB), hepatitis B,…
Authors: Paula Tiittala, Karolina Tuomisto, Taneli Puumalainen, Outi Lyytikäinen, Jukka Ollgren, Olli Snellman and Otto Helve
Citation: BMC Public Health 2018 18:1139
Published on: 24 September 2018

Clinical Trials
Volume 15 Issue 5, October 2018
http://journals.sagepub.com/toc/ctja/15/5

Design
EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country
Thomas Mooney, Elizabeth Smout, Bailah Leigh, Brian Greenwood, Luisa Enria, David Ishola, Daniela Manno, Mohamed Samai, Macaya Douoguih, Deborah Watson-Jones
First Published June 12, 2018; pp. 436–443
Abstract
Background/aims
During the 2014–2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was established and implemented in Sierra Leone to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost Ebola vaccine regimen.
Methods
This article describes the experiences of the EBOVAC-Salone research team in setting up and implementing the trial, and provides recommendations for research teams aiming to conduct clinical trials in future outbreak situations.
Results
Establishing a clinical trial during an outbreak brought some unique challenges, including those related to trial design and the regulatory environment, operational issues, and community engagement. The situation was further complicated by the weak infrastructure and limited experience of clinical trials in Sierra Leone. However, operating in an outbreak context also brought some benefits to the research team, including strong stakeholder support. The EBOVAC-Salone study recruited participants both during and after the outbreak, leading to additional challenges to trial implementation during the post-outbreak transition.
Conclusion
Many lessons have been learned about setting up and implementing a clinical trial during a devastating Ebola epidemic, and some of the experiences of the EBOVAC-Salone team were mirrored by those of other researchers operating in the region. Common to several of these research groups is a recommendation that research should be more closely incorporated into outbreak response planning, which could expedite the establishment of timely and appropriate research projects. We recommend that the lessons learned by researchers during the West African Ebola epidemic are built into programmes and strategies to improve the responses to future epidemics, wherever they occur.

Clinical Trials
Volume 15 Issue 5, October 2018
http://journals.sagepub.com/toc/ctja/15/5

Ethics
The ethics of uninsured participants accessing healthcare in biomedical research: A literature review
Hae Lin Cho, Marion Danis, Christine Grady
First Published August 2, 2018; pp. 509–521
Abstract
Background/aims
Sparse literature exists on the challenges and ethical considerations of including people with limited access to healthcare, such as the uninsured and low-income, in clinical research in high-income countries. However, many ethical issues should be considered with respect to working with uninsured and low-income participants in clinical research, including enrollment and retention, ancillary care, and post-trial responsibilities. Attention to the uninsured and low-income is particularly salient in the United States due to the high rates of uninsurance and underinsurance. Thus, we conducted a scoping review on the ethical considerations of biomedical clinical research with uninsured and low-income participants in high-income countries in order to describe what is known and to pinpoint areas of needed research on this issue.
Methods
MEDLINE/PubMed, Embase, and Scopus databases were searched using terms that described main concepts of interest (e.g., uninsured, underinsured, access to healthcare, poverty, ethics, compensation, clinical research). Articles were included if they met four inclusion criteria: (1) English, (2) high-income countries context, (3) about research participants who are uninsured or low-income, which limits their access to healthcare, and in biomedical clinical research that either had a prospect of direct medical benefit or was offered to them on the basis of their ill health, and (4) recognizes and/or addresses challenges or ethical considerations of uninsured or low-income participants in biomedical clinical research.
Results
The searches generated a total of 974 results. Ultimately, 23 papers were included in the scoping review. Of 23 articles, the majority (n=19) discussed enrollment and retention of uninsured or low-income participants. Several barriers to enrolling uninsured and low-income groups were identified, including limited access to primary or preventive care; lack of access to institutions conducting trials or physicians with enough time or knowledge about trials; overall lack of trust in the government, research, or medical system; and logistical issues. Considerably fewer articles discussed treatment of these participants during the course of research (n=5) or post-trial responsibilities owed to them (n=4). Thus, we propose a research agenda that builds upon the existing literature by addressing three broad questions: (1) What is the current status of uninsured research participants in biomedical clinical research in high-income countries? (2) How should uninsured research participants be treated during and after clinical research? (3) How, if at all, should additional protections for uninsured research participants affect their enrollment?
Conclusions
This review reveals significant gaps in both data and thoughtful analysis on how to ethically involve uninsured research participants. To address these gaps, we propose a research agenda to gather needed data and theoretical analysis that addresses three broad research questions.

Developing World Bioethics
Volume 18, Issue 3  Pages: 205-306  September 2018
https://onlinelibrary.wiley.com/toc/14718847/current
SPECIAL ISSUE: AFRICAN PERSPECTIVES IN GLOBAL BIOETHICS

African Perspectives in Global Bioethics
Mbih Jerome Tosam
Pages: 208-211
First Published: 25 September 2018

Developing World Bioethics
Volume 18, Issue 3  Pages: 205-306  September 2018
https://onlinelibrary.wiley.com/toc/14718847/current
SPECIAL ISSUE: AFRICAN PERSPECTIVES IN GLOBAL BIOETHICS

How to deal with neglected tropical diseases in the light of an African ethic
Thaddeus Metz
Pages: 233-240
First Published: 07 November 2017

Developing World Bioethics
Volume 18, Issue 3  Pages: 205-306  September 2018
https://onlinelibrary.wiley.com/toc/14718847/current
SPECIAL ISSUE: AFRICAN PERSPECTIVES IN GLOBAL BIOETHICS

Global health inequalities and the need for solidarity: a view from the Global South
Mbih J. Tosam, Primus Che Chi, Nchangwi Syntia Munung, Odile Ouwe Missi Oukem‐Boyer, Godfrey B. Tangwa
Pages: 241-249
First Published: 20 December 2017

The European Journal of Public Health
Volume 28, Issue 5, 1 October 2018
https://academic.oup.com/eurpub/issue/28/5
Migration and health

Refusal to provide healthcare to sub-Saharan migrants in France: a comparison according to their HIV and HBV status
Nicolas Vignier; Rosemary Dray Spira; Julie Pannetier; Andrainolo Ravalihasy; Anne Gosselin …
European Journal of Public Health, Volume 28, Issue 5, 1 October 2018, Pages 904–910, https://doi.org/10.1093/eurpub/cky118

The European Journal of Public Health
Volume 28, Issue 5, 1 October 2018
https://academic.oup.com/eurpub/issue/28/5

Infectious and dermatological diseases among arriving migrants on the Italian coasts
Eugenia Di Meco; Anteo Di Napoli; Loredana Maria Amato; Antonio Fortino; Gianfranco Costanzo …
European Journal of Public Health, Volume 28, Issue 5, 1 October 2018, Pages 910–916, https://doi.org/10.1093/eurpub/cky126

The European Journal of Public Health
Volume 28, Issue 5, 1 October 2018
https://academic.oup.com/eurpub/issue/28/5

The growing vaccine hesitancy: exploring the influence of the internet
Mitja Vrdelja; Alenka Kraigher; Dejan Verčič; Samo Kropivnik
European Journal of Public Health, Volume 28, Issue 5, 1 October 2018, Pages 934–939, https://doi.org/10.1093/eurpub/cky114

Global Public Health
Volume 13, 2017  Issue 11
http://www.tandfonline.com/toc/rgph20/current

Article
Why equity in health and in access to health care are elusive: Insights from Canada and South Africa
Solomon Benatar, Terrence Sullivan & Adalsteinn Brown
Pages: 1533-1557
Published online: 04 Dec 2017

Global Public Health
Volume 13, 2017  Issue 11
http://www.tandfonline.com/toc/rgph20/current

Article
Accountability for the human right to health through treaty monitoring: Human rights treaty bodies and the influence of concluding observations
Benjamin Mason Meier, Marlous De Milliano, Averi Chakrabarti & Yuna Kim
Pages: 1558-1576
Published online: 04 Nov 2017
ABSTRACT
Employing novel coding methods to evaluate human rights monitoring, this article examines the influence of United Nations (UN) treaty bodies on national implementation of the human right to health. The advancement of the right to health in the UN human rights system has shifted over the past 20 years from the development of norms under international law to the implementation of those norms through national policy. Facilitating accountability for this rights-based policy implementation under the right to health, the UN Committee on Economic, Social and Cultural Rights (CESCR) monitors state implementation by reviewing periodic reports from state parties, engaging in formal sessions of ‘constructive dialogue’ with state representatives, and issuing concluding observations for state response. These concluding observations recognise the positive steps taken by states and highlight the principal areas of CESCR concern, providing recommendations for implementing human rights and detailing issues to be addressed in the next state report. Through analytic coding of the normative indicators of the right to health in both state reports and concluding observations, this article provides an empirical basis to understand the policy effects of the CESCR monitoring process on state implementation of the right to health.

Global Public Health
Volume 13, 2017  Issue 11
http://www.tandfonline.com/toc/rgph20/current

Article
Prioritising action to accelerate gender equity and health for women and girls: Microdata analysis of 47 countries
Rachel Kidman & Jody Heymann
Pages: 1634-1649
Published online: 18 Jan 2018

Global Public Health
Volume 13, 2017  Issue 11
http://www.tandfonline.com/toc/rgph20/current

Article
Rebuilding people-centred maternal health services in post-Ebola Liberia through participatory action research
Theresa Jones, Lara Ho, Kelvin Koffa Kun, Penelope Milsom, John Shakpeh, Ruwan Ratnayake & Rene Loewenson
Pages: 1650-1669
Published online: 31 Jan 2018
ABSTRACT
During the March 2014–January 2016 Ebola crisis in Liberia, Redemption Hospital lost 12 staff and became a holding facility for suspected cases, prompting violent hostility from the surrounding New Kru Town community, in the capital city Monrovia. Inpatient services were closed for 6 months, leaving the population without maternity care. In January 2015, Redemption reopened, but utilization was low, especially for deliveries. A key barrier was community trust in health workers which worsened during the epidemic. The New Kru Town council, Redemption Hospital, the International Rescue Committee, and Training and Research Support Centre initiated participatory action research (PAR) in July 2015 to build communication between stakeholder groups, and to identify impacts of the epidemic and shared actions to improve the system. The PAR involved pregnant women, community-based trained traditional midwives (TTMs) and traditional birth attendants (TBAs), and community leaders, as well as health workers. Qualitative data and a pre-post survey of PAR participants and community members assessed changes in relationships and maternal health services. The results indicated that Ebola worsened community-hospital relations and pre-existing weaknesses in services, but also provided an opportunity to address these when rebuilding the system through shared action. Findings suggest that PAR generated evidence and improved communication and community and health worker interaction.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 29 Sep 2018]

Research
|   29 September 2018
Sharing public health data and information across borders: lessons from Southeast Asia
The importance of data and information sharing for the prevention and control of infectious diseases has long been recognised. In recent years, public health emergencies such as avian influenza, drug-resistant malaria, and Ebola have brought renewed attention to the need for effective communication channels between health authorities, particularly in regional contexts where neighbouring countries share common health threats. However, little empirical research has been conducted to date to explore the range of factors that may affect the transfer, exchange, and use of public health data and expertise across borders, especially in developing contexts.
Authors: Marco Liverani, Srey Teng, Minh Sat Le and Richard Coke
 

International Journal of Infectious Diseases
September 2018 Volume 74, p1-144
https://www.ijidonline.com/issue/S1201-9712(18)X0007-1

Original Reports
Ebola vaccine development: Systematic review of pre-clinical and clinical studies, and meta-analysis of determinants of antibody response variability after vaccination
Lise Gross, Edouard Lhomme, Chloé Pasin, Laura Richert, Rodolphe Thiebaut
p83–96
Published online: July 5, 2018
 
 

Journal of Epidemiology & Community Health
October 2018 – Volume 72 – 10
http://jech.bmj.com/content/current

Editorial
Exploratory studies to inform full-scale evaluations of complex public health interventions: the need for guidance (11 September, 2018)
Laurence Moore, Britt Hallingberg, Daniel Wight, Ruth Turley, Jeremy Segrott, Peter Craig, Michael Robling, Simon Murphy, Sharon Anne Simpson, Graham Moore
Addressing complex public health problems, such as smoking, obesity and mental health, requires complex, often multilevel, interventions. Given the costs associated with delivering such interventions and the possibility of unanticipated harm, they need to be evaluated using the most robust methods available. It is important, where possible, that public health interventions and their proposed evaluation designs are optimised prior to being subject to an expensive evaluation of their effectiveness, through rigorous assessment of their feasibility.1 Consequently, a growing number of exploratory studies (ie, studies intended to generate the evidence needed to decide whether and how to proceed with a full-scale evaluation, also (inconsistently) referred to as ‘pilot’ or ‘feasibility’ studies) are being conducted…

Journal of Medical Ethics
October 2018 – Volume 44 – 10
http://jme.bmj.com/content/current

Research ethics
Paper: Should all medical research be published? The moral responsibility of medical journal editors (25 September, 2018)
Thomas Ploug

Journal of Medical Ethics
October 2018 – Volume 44 – 10
http://jme.bmj.com/content/current

Paper: Ethics of dead participants: policy recommendations for biobank research
(25 September, 2018)
Lars Ursin, Maria Stuifbergen

The Lancet
Sep 29, 2018 Volume 392 Number 10153 p1089-1166 e8-e9
https://www.thelancet.com/journals/lancet/issue/current

Editorial
The case for investing in WHO
The Lancet
“This is not about only investing in an institution, it’s about investing in people, it’s about investing in a healthier, safer, fairer world”, said Director-General Tedros Adhanom Ghebreyesus at the launch of WHO’s first ever investment case. These emphatic words set the tone for an ambitious goal: to make the case for the investment needed to deliver WHO’s 5-year strategic plan, approved earlier this year—the 13th General Programme of Work, 2019–2023 (GPW13). That WHO is articulating its investment case is unprecedented and welcome. WHO’s work on global public goods (eg, norms, standards, and technical guidance) is more important than ever and is seriously under-appreciated by development partners.

If funded sufficiently, WHO believes the GPW13’s so-called triple billion targets—based on three interconnected priorities: 1 billion more people achieving universal health coverage (UHC), 1 billion more people better protected from health emergencies, and 1 billion more people enjoying better health and wellbeing—could be achieved by 2023. The investment case states that WHO, in joint action with member states and its partners, could save up to 30 million lives, add more than 100 million healthy years of life to populations worldwide, and stimulate 2–4% of economic growth in low-income and middle-income countries by 2023. The only conditionality is money. As previously estimated for GPW13 in May, 2018, to achieve these goals, the investment case estimates that WHO needs US$14·1 billion from 2019 to 2023, which includes a $10 billion base budget, $2·5 million for humani-tarian aid and emergencies, and $1·6 billion for polio eradication. WHO calls on donors for flexible and multiyear funding, the absence of which has impeded its capabilities and commitments. WHO’s current projected income is $4 billion, leaving the agency with the huge task of raising $10·1 billion for the next 5 years.

At first sight, this investment case seems compelling. An investment brochure describes the indispensable work done by WHO to support countries and improve the health of populations worldwide. It lays out a clear and valid strategic direction: to provide leadership, to ensure country impact, and to deliver global public goods. WHO will focus on activities in five specific key health areas, which support achieving the triple-billion targets: human capital, non-communicable diseases, high-impact communicable diseases, antimicrobial resistance, and healthy environment. Surprisingly, the case provides little concrete detail about how WHO will use these funds to deliver on its stated goals. Perplexing is the disconnect between the claims of impact in the investment case and of those in the accompanying technical report, which estimates the health impacts and economic returns for universal health coverage (UHC), health emergencies, and intersectoral action based on a collective global investment—and not for specific investments in WHO. Thus, the UHC return of 25·1 million deaths averted is based on a global investment of $1·1 trillion as set out in the technical report. However, the WHO investment case seems to suggest that investing $14·1 billion in WHO alone will generate these returns. The technical report seems to bear little relation to the investment case for WHO.

A valuable contribution of the investment case would have been to clearly articulate what WHO will actually do in its three priority areas and where its comparative advantage lies: global public goods and normative work, emergency preparedness, and support to countries in developing the health policies needed to achieve the Sustainable Development Goals (SDGs). At a time when WHO is competing for limited donor resources against other institutions, such as The Global Fund to Fight AIDS, Tuberculosis and Malaria and Gavi, The Vaccine Alliance, a clear explanation of how additional investments will deliver the goals set out in the investment case seems crucial. A more precise analysis could have made the case for a chronically underfunded but desperately useful and overlooked part played by WHO: that of providing global public goods, which need to be reinforced to reach the SDGs and respond to old and emerging global health threats.

WHO’s historic and institutional strengths lie in responding to the urgent needs of its member states. But during the past decade, WHO’s budget has been tied to donor conditionalities and has failed to grow in real terms. Therefore, it is right that WHO is calling on donors to strengthen the agency’s global, regional, and country capacities to take advantage of the opportunities that exist for improving human health. Sharpening the investment case still further will go a long way to fulfil that opportunity.

13th General Programme of Work (2019-2023) see White paper 2018
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32289-X/fulltext

The Lancet
Sep 29, 2018 Volume 392 Number 10153 p1089-1166 e8-e9
https://www.thelancet.com/journals/lancet/issue/current

Comment
Addressing the fragmentation of global health: the Lancet Commission on synergies between universal health coverage, health security, and health promotion
Gorik Ooms, Trygve Ottersen, Albrecht Jahn, Irene Akua Agyepong
Global health is fragmented. Many stakeholders pursue their own agenda while neglecting other important goals for global health. Some global health actors, for example, focus on strengthening health security without attention to universal health coverage (UHC), primary health care (PHC), and population-based health promotion. Prevention is a key part of PHC and UHC, but efforts to ensure PHC or make progress towards UHC often do not include population-based prevention efforts. Proponents often use broad definitions of their agenda in declarations and statements, while applying much narrower definitions in practice. If these tensions are not addressed, fragmentation will continue to make local, national, and global efforts inefficient and opportunities will be lost in terms of lives saved and quality of life.

The Lancet
Sep 29, 2018 Volume 392 Number 10153 p1089-1166 e8-e9
https://www.thelancet.com/journals/lancet/issue/current

Viewpoint
Repositioning Africa in global knowledge production
Sharon Fonn, Laban Peter Ayiro, Philip Cotton, Adam Habib, Peter Mulwa Felix Mbithi, Alfred Mtenje, Barnabas Nawangwe, Eyitope O Ogunbodede, Idowu Olayinka, Frederick Golooba-Mutebi, Alex Ezeh
Introduction
Sub-Saharan Africa accounts for 13·5% of the global population but less than 1% of global research output. In 2008, Africa produced 27 000 published papers—the same number as The Netherlands. Informed by a nuanced understanding of the causes of the current scenario, we propose action that should be taken by African universities, governments, and development partners to foster the development of research-active universities on the continent…

Lancet Global Health
Oct 2018 Volume 6 Number 10 e1045-e1138
http://www.thelancet.com/journals/langlo/issue/current

Editorial
 A new era for tuberculosis?
The Lancet Global Health
In his keynote speech at this year’s Consortium of Universities for Global Health meeting in March, the former UN Secretary-General’s Special Envoy for HIV/AIDS in Africa, Stephen Lewis, delivered a blistering attack on the global response to tuberculosis. Citing it as one of three glaring examples of the consequences of inequalities worldwide (the others being climate change and conflict), he pointed to the 280-fold difference in tuberculosis incidence between Canadian Inuits and the non-Indigenous Canadian-born population, and to the “callous starvation” of funding for multidrug-resistant (MDR) disease in India despite the country’s massive burden.

Tuberculosis is the leading infectious killer globally and disproportionately affects disadvantaged populations—eg, homeless people, prisoners, migrants, people living with HIV. It therefore rightly maintains its place in the Sustainable Development Goals, whose guiding principle is to leave no one behind. The WHO End TB Strategy fleshes out these targets (ie, to reduce deaths by 95% and new cases by 90% between 2015 and 2035, and to ensure that no family suffers catastrophic expenses). Yet current progress is not commensurate with these ambitious aims. Stephen Lewis went so far as to call Narendra Modi’s assertion that India would eradicate tuberculosis by 2025 “nonsense”. This month sees an opportunity to change things for the better. On Sept 26, heads of state will gather in New York at the first UN High-Level Meeting (HLM) on tuberculosis with the aim of uniting to reboot progress and culminating in an “ambitious political declaration”. Will it make any difference?

UN HLMs are convened when there is a perceived need to engage all sectors in order to effect developmental, social, and economic change. Tuberculosis is indeed the epitome of a developmental, social, and economic problem. As Priya Shete and colleagues point out in a Comment published today, “Being poor increases the risk of falling sick with tuberculosis. Falling sick with tuberculosis also leads to impoverishment that can trigger a downward spiral of worsening health, ongoing tuberculosis transmission, and crippling medical expenses which further entrench poverty.” Referencing a modelling study published in The Lancet Global Health earlier this year, which estimated that expanding social protection coverage could reduce the global incidence of tuberculosis by 76% by 2035, Shete and colleagues call for integration of social protection with tuberculosis care within policies, programmes, and research.

Parallel efforts to highlight the importance of access to affordable tuberculosis drugs, particularly for MDR strains, have been ongoing ahead of the HLM. Earlier drafts of the political declaration—the key outcome document of the HLM—contained reference to the full use of flexibilities in intellectual property rules geared towards maximising access. Yet, under pressure from the USA and others, the final draft saw these provisions weakened. South Africa, which the same month became the first country in the world to roll out bedaquiline to all eligible patients with MDR tuberculosis (and at a reduced price) protested and negotiations were reopened. As we went to press, it was unclear whether the text would be reinstated.

Last month, WHO issued a rapid communication summarising key changes it will be making to its guidelines on the treatment of MDR tuberculosis. These include prioritising newer oral drugs, including bedaquiline, over injectables. The changes are justified by an individual patient data meta-analysis published in The Lancet last week, which found that “the traditionally used drugs for treatment of multidrug-resistant tuberculosis, especially oral second-line drugs and even the injectable drugs, appear to be less effective than the later generation fluoroquinolones, linezolid, bedaquiline, clofazimine, and possibly the carbapenems”. New trials are also underway to find shorter, less debilitating, treatment regiments for MDR tuberculosis, including the SimpliciTB and endTB trials.

There are many priorities in the complex and centuries-long fight against this cruel disease. But to suggest, as did a US representative at the recent civil society hearing ahead of the HLM, that global efforts should focus on improving health systems and new tools, rather than being “distracted, as we so often are, into a discussion of access to medicines, intellectual property flexibilities, or compulsory licensing” is plainly absurd. New tools include new (expensive) medicines and health systems cannot improve if WHO-recommended regimens cannot be afforded. Will the HLM make a difference? Not as long as commercial protectionism trumps social justice.

Lancet Infectious Diseases
Oct 2018 Volume 18 Number 10 p1047-1160 e295-e338
http://www.thelancet.com/journals/laninf/issue/current

Editorial
Ending cholera for all
The Lancet Infectious Diseases
Cholera, a bacterial diarrhoeal infection caused by Vibrio cholerae and transmitted by the faecal–oral route, is not a disease recently associated with Algeria. Indeed, in a report published by the Global Task Force on Cholera Control (GTFCC) on Oct 3, 2017, Ending Cholera—A Global Roadmap to 2030, Algeria is not listed among the 47 countries affected by the disease. But, having had no cases since 1994, from Aug 7–30, 2018, 74 confirmed cholera cases including two deaths were reported in six northern and coastal districts of the country. V cholerae has been isolated from a natural water source, not connected to the public water system, in the region of Tipaza. How the water source became contaminated is unclear; spread of the disease to other regions of Algeria via contaminated fruit and vegetables is a possibility. The outbreak in Algeria, although small in scale, is a timely reminder that cholera is an epidemic infection that can reappear after disease-free decades in circumstances of unsafe water supply and sanitation.

The vulnerability of people to cholera from unsafe drinking water sources was emphasised in a commitment made by African health ministers on Aug 28—at the same time as the Algeria outbreak—to implement strategies to end cholera in the Africa region by 2030. 17 African countries reported more than 150 000 cholera cases in 2017, and currently eight countries on the continent are dealing with outbreaks. The commitment made by African governments is an endorsement of the strategies set out in the Global Roadmap published last year. This plan aims to support countries to reduce cholera deaths by 90% by 2030, with up to 20 countries having eliminated the disease as a public health threat.

As we noted in an Editorial in 2017, cholera is a disease of poor and vulnerable populations, notably in conflict situations and where sanitation and hygiene are inadequate. Known pandemics of cholera, originating from south and southeast Asia, have occurred since the early 19th century, affecting all parts of the world. However, improvements in safe water and sewage disposal eliminated the disease from high-income countries during the 20th century. The outbreaks currently affecting the world, which kill an estimated 107 000 people per year, are remnants of the seventh pandemic, which began in Indonesia in 1961. That 57 years later—despite having the knowledge and means to hand to effect change—the disease is still a threat to human health marks a failure of global public health.

The Global Roadmap admits that the GTFCC, which was created in 1992, “became inactive after elimination of cholera in the Americas” in the early 2000s. It took a World Health Assembly resolution in 2011 to revitalise cholera control efforts. A paper published online by the Journal of Infectious Diseases on Sept 1, notes four factors that have converged to make cholera elimination feasible: increased emphasis on equity, as exemplified by the Sustainable Development Goals, with occurrence of cholera indicative of people’s access to basic water and sanitation services; the technical capacity to detect cholera quickly; availability of oral cholera vaccine (OCV) in sufficient quantity to manage large outbreaks; and an increasing degree of politic commitment in affected countries (as shown by the African health ministers’ declaration).

The objectives for 2030 in the Global Roadmap are based on three axes: early detection and response to contain outbreaks through, for example, surveillance systems, prepositioning essential supplies, monitoring water sources, and mass vaccination campaigns; targeting cholera hotspots through, in addition to the above, providing sustainable safe water and sanitation networks and building the capacity of health-care systems; and effective coordination of technical support and resources at local and global levels.

Of the various resources needed to achieve global cholera control, the availability of OCVs is encouraging, with 25 million doses predicted to be in the stockpile this year. And there is evidence of national political commitment, with the Government of Uganda launching on Sept 5, an OCV campaign targeting 1·6 million people living in cholera hotspots. But ultimately cholera control requires civil engineering through building a robust infrastructure of clean water supply and sewage disposal and treatment. The initial investment may seem great, but it is less so when considered per head of population over decades, for the reduction in other water-related diseases, and for the increased wellbeing and productivity of a country’s people.

Lancet Infectious Diseases
Oct 2018 Volume 18 Number 10 p1047-1160 e295-e338
http://www.thelancet.com/journals/laninf/issue/current

Comment
Measles: is a new vaccine approach needed?
Cléa Melenotte, Christine Zandotti, Philippe Gautret, Philippe Parola, Didier Raoult
WHO’s goal was to eradicate measles in the 20th century, but measles still represents a public health challenge in the developing world, and in Europe, where epidemic outbreaks are regularly reported

Lancet Infectious Diseases
Oct 2018 Volume 18 Number 10 p1047-1160 e295-e338
http://www.thelancet.com/journals/laninf/issue/current

Articles
Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, Y, W, and X in healthy adults: a phase 1, single-centre, double-blind, randomised, controlled study
Wilbur H Chen, Kathleen M Neuzil, C Rebecca Boyce, Marcela F Pasetti, Mardi K Reymann, Lionel Martellet, Nancy Hosken, F Marc LaForce, Rajeev M Dhere, Sambhaji S Pisal, Amol Chaudhari, Prasad S Kulkarni, Ray Borrow, Helen Findlow, Valerie Brown, Megan L McDonough, Len Dally, Mark R Alderson

Lancet Infectious Diseases
Oct 2018 Volume 18 Number 10 p1047-1160 e295-e338
http://www.thelancet.com/journals/laninf/issue/current

Review
The respiratory syncytial virus vaccine landscape: lessons from the graveyard and promising candidates
Natalie I Mazur, Deborah Higgins, Marta C Nunes, José A Melero, Annefleur C Langedijk, Nicole Horsley, Ursula J Buchholz, Peter J Openshaw, Jason S McLellan, Janet A Englund, Asuncion Mejias, Ruth A Karron, Eric AF Simões, Ivana Knezevic, Octavio Ramilo, Pedro A Piedra, Helen Y Chu, Ann R Falsey, Harish Nair, Leyla Kragten-Tabatabaie, Anne Greenough, Eugenio Baraldi, Nikolaos G Papadopoulos, Johan Vekemans, Fernando P Polack, Mair Powell, Ashish Satav, Edward E Walsh, Renato T Stein, Barney S Graham, Louis J Bont in collaboration with Respiratory Syncytial Virus Network (ReSViNET) Foundation

Lancet Infectious Diseases
Oct 2018 Volume 18 Number 10 p1047-1160 e295-e338
http://www.thelancet.com/journals/laninf/issue/current

Experimental infection of human volunteers
Meta Roestenberg, Marie-Astrid Hoogerwerf, Daniela M Ferreira, Benjamin Mordmüller, Maria Yazdanbakhsh
Summary
Controlled human infection (CHI) trials, in which healthy volunteers are experimentally infected, can accelerate the development of novel drugs and vaccines for infectious diseases of global importance. The use of CHI models is expanding from around 60 studies in the 1970s to more than 120 publications in this decade, primarily for influenza, rhinovirus, and malaria. CHI trials have provided landmark data for several registered drugs and vaccines, and have generated unprecedented scientific insights. Because of their invasive nature, CHI studies demand critical ethical review according to established frameworks. CHI-associated serious adverse events are rarely reported. Novel CHI models need standardised safety data from comparable CHI models to facilitate evidence-based risk assessments, as well as funds to produce challenge inoculum according to regulatory requirements. Advances such as the principle of controlled colonisation, the expansion of models to endemic areas, and the use of genetically attenuated strains will further broaden the scope of CHI trials.

Lancet Infectious Diseases
Oct 2018 Volume 18 Number 10 p1047-1160 e295-e338
http://www.thelancet.com/journals/laninf/issue/current

Personal View
The dynamic role of dengue cross-reactive immunity: changing the approach to defining vaccine safety and efficacy
Kathryn B Anderson, Timothy P Endy, Stephen J Thomas
Summary
Dengue virus infections cause a substantial public health burden in tropical and subtropical regions. A single dengue vaccine has been approved by regulatory authorities in 19 countries, but concerns regarding vaccine safety in people who are dengue naive at the time of immunisation has introduced uncertainty into the vaccine’s future. As other dengue vaccines complete or enter large-scale efficacy trials, we argue that foundational work by Sabin, historic epidemiological observations of dengue outbreaks, and prospective cohort studies in Asia and the Americas indicate that modifications must be made to the methods of assessing dengue vaccines. In this Personal View, we review and relate previous data that supports a dynamic role of cross-protective dengue immunity to the goals and challenges of measuring and interpreting dengue vaccine immunogenicity, efficacy, and safety in clinical trials. We suggest that for partly protective vaccines, temporary cross-protective immunity could lead to overestimation of vaccine safety and efficacy in the early years following vaccination. We recommend that assessment of dengue vaccines should span several years, involve active surveillance to clinically characterise incident infections and regular blood draws to define kinetic changes in immunological profiles, and include sample sizes that are large enough to support detailed analyses of vaccine trial subgroups, such as individuals who are dengue naive.

Maternal and Child Health Journal
Volume 22, Issue 1 Supplement, October 2018
https://link.springer.com/journal/10995/22/1/suppl/page/1
Special Issue: Taking Home Visiting to Scale: Findings from the Maternal, Infant, and Early Childhood Home Visiting Program State-Led Evaluations
Issue Editors: Nicole Denmark, Kyle Peplinski, Mariel Sparr, Judy Labiner-Wolfe, Susan Zaid,
Pooja Gupta, Kassie Mae Miller

Editorial
Introduction to the Special Issue on Taking Home Visiting to Scale: Findings from the Maternal, Infant, and Early Childhood Home Visiting Program State-Led Evaluations
Nicole Denmark, Kyle Peplinski, Mariel Sparr…
Abstract
The Maternal, Infant and Early Childhood Home Visiting (MIECHV) Program is a two-generation approach to supporting healthy families through home visits during pregnancy and early childhood. All states and territories receiving MIECHV funding are encouraged to evaluate their programs. This special issue highlights evaluations from 11 awardees—Arkansas, Florida, Illinois, Iowa, Maryland, Massachusetts, Michigan, New Jersey, Oregon, Pennsylvania, and Tennessee. With the wide expansion of home visiting since the onset of MIECHV, the state-led evaluations contribute to the understanding of replication and scale-up of evidence-based home visiting.

Medical Decision Making (MDM)
Volume 38 Issue 7, October 2018
http://mdm.sagepub.com/content/current

Original Articles
Future Directions for Cost-effectiveness Analyses in Health and Medicine
Peter J. Neumann, David D. Kim, Thomas A. Trikalinos, Mark J. Sculpher, Joshua A. Salomon, Lisa A. Prosser, Douglas K. Owens, David O. Meltzer, Karen M. Kuntz, Murray Krahn, David Feeny, Anirban Basu, Louise B. Russell, Joanna E. Siegel, Theodore G. Ganiats, Gillian D. Sanders
Abstract
Objectives. In 2016, the Second Panel on Cost-effectiveness in Health and Medicine updated the seminal work of the original panel from 2 decades earlier. The Second Panel had an opportunity to reflect on the evolution of cost-effectiveness analysis (CEA) and to provide guidance for the next generation of practitioners and consumers. In this article, we present key topics for future research and policy.
Methods. During the course of its deliberations, the Second Panel discussed numerous topics for advancing methods and for improving the use of CEA in decision making. We identify and consider 7 areas for which the panel believes that future research would be particularly fruitful. In each of these areas, we highlight outstanding research needs. The list is not intended as an exhaustive inventory but rather a set of key items that surfaced repeatedly in the panel’s discussions. In the online Appendix, we also list and expound briefly on 8 other important topics.
Results. We highlight 7 key areas: CEA and perspectives (determining, valuing, and summarizing elements for the analysis), modeling (comparative modeling and model transparency), health outcomes (valuing temporary health and path states, as well as health effects on caregivers), costing (a cost catalogue, valuing household production, and productivity effects), evidence synthesis (developing theory on learning across studies and combining data from clinical trials and observational studies), estimating and using cost-effectiveness thresholds (empirically representing 2 broad concepts: opportunity costs and public willingness to pay), and reporting and communicating CEAs (written protocols and a quality scoring system).
Conclusions. Cost-effectiveness analysis remains a flourishing and evolving field with many opportunities for research. More work is needed on many fronts to understand how best to incorporate CEA into policy and practice

New England Journal of Medicine
September 27, 2018  Vol. 379 No. 13
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Outbreaks in a Rapidly Changing Central Africa — Lessons from Ebola
Vincent J. Munster, Ph.D., Daniel G. Bausch, M.D., Emmie de Wit, Ph.D., Robert Fischer, Ph.D.,
Gary Kobinger, Ph.D., César Muñoz-Fontela, Ph.D., Sarah H. Olson, Ph.D., Stephanie N. Seifert, Ph.D., Armand Sprecher, M.D., Francine Ntoumi, Ph.D., Moses Massaquoi, M.D., and Jean-Vivien Mombouli, Ph.D.
[Initial text]
West and Central Africa are experiencing explosive growth in urban populations, economic activities, and connectivity. The recent Ebola virus epidemic in West Africa demonstrated the vulnerability of the local health care infrastructure to newly emerging infectious diseases. Two key factors contributing to the epidemic’s unprecedented size were growth-related: large urban populations that overwhelmed the public health infrastructure of these resource-poor countries and the extensive spatial and technological connectivity of the population.1 These factors portend an increased risk in Central Africa of emerging infectious diseases caused by both known and unknown pathogens. Such unwelcome side effects of rapid growth can be mitigated only by strengthening the health care infrastructure, including diagnostic and clinical capacity, to meet the health care needs of the population; investment in the training of health care workers and African scientists; expansion of research capacity; development of disease-surveillance programs focused on humans, livestock, and wildlife; and rapid deployment of control measures when outbreaks occur…

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 29 Sep 2018]

Measuring Mosquito-borne Viral Suitability in Myanmar and Implications for Local Zika Virus Transmission
September 28, 2018 · Research Article
Introduction: In South East Asia, mosquito-borne viruses (MBVs) have long been a cause of high disease burden and significant economic costs. While in some SEA countries the epidemiology of MBVs is spatio-temporally well characterised and understood, in others such as Myanmar our understanding is largely incomplete.
Materials and Methods: Here, we use a simple mathematical approach to estimate a climate-driven suitability index aiming to better characterise the intrinsic, spatio-temporal potential of MBVs in Myanmar.
Results: Results show that the timing and amplitude of the natural oscillations of our suitability index are highly informative for the temporal patterns of DENV case counts at the country level, and a mosquito-abundance measure at a city level. When projected at fine spatial scales, the suitability index suggests that the time period of highest MBV transmission potential is between June and October independently of geographical location. Higher potential is nonetheless found along the middle axis of the country and in particular in the southern corridor of international borders with Thailand.
Discussion: This research complements and expands our current understanding of MBV transmission potential in Myanmar, by identifying key spatial heterogeneities and temporal windows of importance for surveillance and control. We discuss our findings in the context of Zika virus given its recent worldwide emergence, public health impact, and current lack of information on its epidemiology and transmission potential in Myanmar. The proposed suitability index here demonstrated is applicable to other regions of the world for which surveillance data is missing, either due to lack of resources or absence of an MBV of interest.