JAMA
October 2, 2018, Vol 320, No. 13, Pages 1297-1396
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Addressing the Tuberculosis Epidemic – 21st Century Research for an Ancient Disease
Anthony S. Fauci, MD
JAMA. 2018;320(13):1315-1316. doi:10.1001/jama.2018.12852
In this Viewpoint, Anthony Fauci summarizes the National Institute of Allergy and Infectious Diseases’ (NIAID’s) 2018 Strategic Plan for Tuberculosis (TB), which comprises investments in development of point-of-care diagnostics, vaccines, shorter-duration therapeutics, and infrastructure for systems biology and “omics” approaches to the infection.

JAMA
October 2, 2018, Vol 320, No. 13, Pages 1297-1396
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Crossing the Global Health Care Quality Chasm – A Key Component of Universal Health Coverage
Donald Berwick, MD; Megan Snair, MPH; Sania Nishtar, PhD, FRCP
JAMA. 2018;320(13):1317-1318. doi:10.1001/jama.2018.13696
In this Viewpoint, Don Berwick and colleagues summarize a 2018 National Academies of Sciences, Engineering, and Medicine (NASEM) report on global health care quality emphasizing that universal access will yield improvements in population health only when paired with quality reforms characterized by systems design, transparency, collaboration, anticipatory care, evidence-based decisions, and continuous feedback and learning.

JAMA Pediatrics
October 2018, Vol 172, No. 10, Pages 897-996
http://archpedi.jamanetwork.com/issue.aspx

Original Investigation
Rotavirus Vaccination and the Global Burden of Rotavirus Diarrhea Among Children Younger Than 5 Years
Christopher Troeger, MPH; Ibrahim A. Khalil, MD; Puja C. Rao, MPH; et al.
JAMA Pediatr. 2018;172(10):958-965. doi:10.1001/jamapediatrics.2018.1960
This analysis of data from the Global Burden of Disease Study examines the extent of rotavirus infection and associated deaths among children younger than 5 years worldwide and whether the rotavirus vaccine has reduced the diarrhea-associated mortality.

Journal of Adolescent Health
October 2018 Volume 63, Issue 4, p377-518
https://www.jahonline.org/issue/S1054-139X(17)X0025-6

Position Paper
HIV Pre-Exposure Prophylaxis Medication for Adolescents and Young Adults: A Position Paper of the Society for Adolescent Health and Medicine
Society for Adolescent Health and Medicine
p513–516
Published in issue: October 2018

Journal of Virology
October 2018; Volume 92,Issue 20
http://jvi.asm.org/content/current

Gem
Discovering Invisible Truths
Ilaria Capua
The rise of populist movements worldwide is challenging science and motivating scientists to join the debate and enter politics. Based on my experience, taking a public stand will not come without slanderous personal and institutional attacks as an attempt to shake scientific credibility.

The Lancet
Oct 06, 2018 Volume 392 Number 10154 p1167-1278  e10
https://www.thelancet.com/journals/lancet/issue/current

Articles
Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial
Nicholas O Opoku, Didier K Bakajika, Eric M Kanza, Hayford Howard, Germain L Mambandu, Amos Nyathirombo, Maurice M Nigo, Kambale Kasonia, Safari L Masembe, Mupenzi Mumbere, Kambale Kataliko, Jemmah P Larbelee, Mawolo Kpawor, Kpehe M Bolay, Fatorma Bolay, Sampson Asare, Simon K Attah, George Olipoh, Michel Vaillant, Christine M Halleux, Ann
The morbidity and socioeconomic effects of onchocerciasis, a parasitic disease that is primarily endemic in sub-Saharan Africa, have motivated large morbidity and transmission control programmes. Annual community-directed ivermectin treatment has substantially reduced prevalence. Elimination requires intensified efforts, including more efficacious treatments. We compared parasitological efficacy and safety of moxidectin and ivermectin.

The Lancet
Oct 06, 2018 Volume 392 Number 10154 p1167-1278  e10
https://www.thelancet.com/journals/lancet/issue/current

Articles
Measuring human capital: a systematic analysis of 195 countries and territories, 1990–2016
Stephen S Lim, Rachel L Updike, Alexander S Kaldjian, Ryan M Barber, Krycia Cowling, Hunter York, Joseph Friedman, R Xu, Joanna L Whisnant, Heather J Taylor, Andrew T Leever, Yesenia Roman, Miranda F Bryant, Joseph Dieleman, Emmanuela Gakidou, Christopher J L Murray
Human capital is recognised as the level of education and health in a population and is considered an important determinant of economic growth. The World Bank has called for measurement and annual reporting of human capital to track and motivate investments in health and education and enhance productivity. We aim to provide a new comprehensive measure of human capital across countries globally.

Nature Reviews Immunology
Volume 18 Issue 10, October 2018
https://www.nature.com/nri/volumes/18/issues/10

Comment | 04 August 2018
From the Human Cell Atlas to dynamic immune maps in human disease
Scientists involved in the Human Cell Atlas Project describe its potential as a resource for future research and the challenges that lie ahead.
Lorenz Adlung  & Ido Amit

Nature Reviews Immunology
Volume 18 Issue 10, October 2018
https://www.nature.com/nri/volumes/18/issues/10

Review Article | 25 July 2018
CAR T cells for infection, autoimmunity and allotransplantation
This Review explores the challenges and opportunities of taking CARs down new therapeutic roads, in terms of developing chimeric antigen receptors (CARs) for treating infectious disease, autoimmunity and transplant rejection.
Colby R. Maldini, Gavin I. Ellis & James L. Riley
Abstract
Chimeric antigen receptors (CARs) have shown remarkable ability to re-direct T cells to target CD19-expressing tumours, resulting in remission rates of up to 90% in individuals with paediatric acute lymphoblastic lymphoma. Lessons learned from these clinical trials of adoptive T cell therapy for cancer, as well as investments made in manufacturing T cells at commercial scale, have inspired researchers to develop CARs for additional applications. Here, we explore the challenges and opportunities of using this technology to target infectious diseases such as with HIV and undesired immune responses such as autoimmunity and transplant rejection. Despite substantial obstacles, the potential of CAR T cells to enable cures for a wide array of disease settings could be transformational for the medical field.

New England Journal of Medicine
October 4, 2018  Vol. 379 No. 14
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Being PrEPared — Preexposure Prophylaxis and HIV Disparities
Robert H. Goldstein, M.D., Ph.D., Carl G. Streed, Jr., M.D., and Sean R. Cahill, Ph.D.
[Initial text]
If current trends persist, one in six U.S. men who have sex with men will be infected with human immunodeficiency virus (HIV) in their lifetime, according to the Centers for Disease Control and Prevention (CDC).¹ This prediction highlights the long road ahead if we are to end the spread of HIV in the United States, but it does not tell the full story, which is complicated and nuanced. Of the 39,782 new HIV infections that occurred in the United States in 2016, nearly half were in black or Latino men who have sex with men, and 52% occurred in the South (a region defined by the CDC as Alabama, Arkansas, Delaware, the District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and West Virginia).¹ Preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine (TDF–FTC), which the CDC has recommended since 2014 as a safe and very effective method of preventing HIV infection in high-risk populations, is an underused tool for reducing this alarming imbalance…

New England Journal of Medicine
October 4, 2018  Vol. 379 No. 14
http://www.nejm.org/toc/nejm/medical-journal

Review Article
Frontiers in Medicine: Next-Generation Sequencing to Diagnose Suspected Genetic Disorders
David R. Adams, M.D., Ph.D., and Christine M. Eng, M.D.
The technologies and chemistries underlying next-generation sequencing of DNA are evolving rapidly. This review describes the three main approaches to obtaining a genetic diagnosis through next-generation sequencing, their advantages, and their limitations.

PLoS One
http://www.plosone.org/
[Accessed 6 Oct 2018 ]

Research Article
Health system measurement: Harnessing machine learning to advance global health
Further improvements in population health in low- and middle-income countries demand high-quality care to address an increasingly complex burden of disease. Health facility surveys provide an important but costly source of information on readiness to provide care. To improve the efficiency of health system measurement, we applied unsupervised machine learning methods to assess the performance of the service readiness index (SRI) defined by the World Health Organization and compared it to empirically derived indices.
Hannah H. Leslie, Xin Zhou, Donna Spiegelman, Margaret E. Kruk
Research Article | published 05 Oct 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0204958

PLoS One
http://www.plosone.org/
[Accessed 6 Oct 2018 ]

Research Article
Oral cholera vaccine coverage during a preventive door-to-door mass vaccination campaign in Nampula, Mozambique
In addition to improving water, sanitation and hygiene (WASH) measures and optimal case management, the introduction of Oral cholera vaccine (OCV) is a complementary strategy for cholera prevention and control for vulnerable population groups. In October 2016, the Mozambique Ministry of Health implemented a mass vaccination campaign using a two-dose regimen of the Shanchol™ OCV in six high-risk neighborhoods of Nampula city, in Northern Mozambique. Overall 193,403 people were targeted by the campaign, which used a door-to-door strategy. During campaign follow-up, a population survey was conducted to assess: (1) OCV coverage; (2) frequency of adverse events following immunization; (3) vaccine acceptability and (4) reasons for non-vaccination.
Cynthia Semá Baltazar, Florentina Rafael, José Paulo M. Langa, Sergio Chicumbe, Philippe Cavailler, Bradford D. Gessner, Lorenzo Pezzoli, Américo Barata, Dores Zaina, Dortéia L. Inguane, Martin A. Mengel, Aline Munier
Research Article | published 03 Oct 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0198592

PLoS Pathogens
http://journals.plos.org/plospathogens/
[Accessed 6 Oct 2018 ]

Opinion
Inoculating science against potential pandemics and information hazards
Kevin M. Esvelt
| published 04 Oct 2018 PLOS Pathogens
https://doi.org/10.1371/journal.ppat.1007286
Abstract
The recent de novo assembly of horsepox is an instructive example of an information hazard: published methods enabling poxvirus synthesis led to media coverage spelling out the implications, efficiently disseminating true information that might be used to cause harm. Whether or not the benefits justified the risks, the horsepox saga provides ample reason to upgrade the current system for screening synthesized DNA for hazardous sequences, which does not cover the majority of firms and cannot reliably prevent the assembly of potentially pandemic pathogens. An upgraded system might leverage one-way encryption to confidentially scrutinize virtually all commercial production by a cooperative international network of servers whose integrity can be verified by third parties. Funders could support participating institutions to ease the transition or outright subsidize the market to make clean DNA cheaper, while boycotts by journals, institutions, and funders could ensure compliance and require hardware-level locks on future DNA synthesizers. However, the underlying problem is that security and safety discussions among experts typically follow potentially hazardous events rather than anticipating them. Changing norms and incentives to favor preregistration and advisory peer review of planned experiments could test alternatives to the current closeted research model in select areas of science. Because the fields of synthetic mammalian virology and especially gene drive research involve technologies that could be unilaterally deployed and may self-replicate in the wild, they are compelling candidates for initial trials of early-stage peer review.

Risk Analysis          
Volume 38, Issue 10  Pages: 2011-2241  October 2018
https://onlinelibrary.wiley.com/toc/15396924/current

Original Research Article
It’s Complicated: The 2014–2015 U.S. Measles Outbreak and Parents’ Vaccination Beliefs, Confidence, and Intentions
Michael A. Cacciatore, Glen J. Nowak, Nathaniel J. Evans
Pages: 2178-2192
First Published: 06 June 2018
Abstract
While it seems intuitive that highly visible vaccine‐preventable disease outbreaks should impact perceptions of disease risk and facilitate vaccination, few empirical studies exist to confirm or dispel these beliefs. This study investigates the impact of the 2014–2015 Disneyland measles outbreak on parents’ vaccination attitudes and future vaccination intentions. The analysis relies on a pair of public opinion surveys of American parents with at least one child under the age of six (N = 1,000 across each survey). Controlling for basic demographics, we found higher levels of reported confidence in the safety and efficacy of childhood vaccinations in our follow‐up data collection. However, this confidence was also accompanied by elevated levels of concern toward childhood vaccines among American parents. We then examined how different subgroups in the population scored on these measures before and after the outbreak. We found that parents with high levels of interest in the topic of vaccines and a child who is not fully upto date with the recommended vaccination schedule reported more supportive attitudes toward vaccines. However, future intentions to follow the recommended vaccination schedule were not positively impacted by the outbreak. Possible explanations for these results and implications for vaccination outreach are discussed.

Science         
05 October 2018  Vol 362, Issue 6410
http://www.sciencemag.org/current.dtl
Special Issue – Diving within Saturn’s rings

Reports
Urbanization and humidity shape the intensity of influenza epidemics in U.S. cities
By Benjamin D. Dalziel, Stephen Kissler, Julia R. Gog, Cecile Viboud, Ottar N. Bjørnstad, C. Jessica E. Metcalf, Bryan T. Grenfell
Science05 Oct 2018 : 75-79 Open Access
Seasonal flu epidemics are more diffuse in larger cities and more intense in smaller cities, where climate has a stronger influence on transmission.
Seasonal flu by ZIP code
Influenza virus strikes communities in northern latitudes during winter, straining health care provision almost to the breaking point. Change in environmental humidity is a key driver, but many other seasonal and social factors contribute. Dalziel et al. obtained a geographical distribution of doctor visits for influenza-like illness for more than 600 U.S. cities (see the Perspective by Wallinga). Some ZIP codes regularly experienced sharply defined peaks of cases, or intense epidemics, and others showed a longer, more diffuse influenza season. The surges tended to occur in smaller cities with less residential density and lower household incomes. Larger, more densely populated cities had more-diffuse epidemics, presumably because of higher rates of personal contact, which makes influenza transmission less subject to climate variation.
Abstract
Influenza epidemics vary in intensity from year to year, driven by climatic conditions and by viral antigenic evolution. However, important spatial variation remains unexplained. Here we show predictable differences in influenza incidence among cities, driven by population size and structure. Weekly incidence data from 603 cities in the United States reveal that epidemics in smaller cities are focused on shorter periods of the influenza season, whereas in larger cities, incidence is more diffuse. Base transmission potential estimated from city-level incidence data is positively correlated with population size and with spatiotemporal organization in population density, indicating a milder response to climate forcing in metropolises. This suggests that urban centers incubate critical chains of transmission outside of peak climatic conditions, altering the spatiotemporal geometry of herd immunity.

Science Translational Medicine
03 October 2018  Vol 10, Issue 461
http://stm.sciencemag.org/

Perspective
Regulating 3D-printed medical products
By Laura M. Ricles, James C. Coburn, Matthew Di Prima, Steven S. Oh
Science Translational Medicine03 Oct 2018 Restricted Access
There are a number of key considerations in the U.S. regulatory landscape regarding approval of 3D-printed medical devices and biologics.
Abstract
Additive manufacturing [also known as three-dimensional (3D) printing] is the layer-wise deposition of material to produce a 3D object. This rapidly emerging technology has the potential to produce new medical products with unprecedented structural and functional designs. Here, we describe the U.S. regulatory landscape of additive manufactured (3D-printed) medical devices and biologics and highlight key challenges and considerations.

Vaccine
Volume 36, Issue 42   Pages 6249-6360 (8 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/42
[New issue; No digest content identified]

 
Vaccine
Volume 36, Issue 43  Pages 6361-6456 (15 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/43
Research article  Abstract only
Preferences for health economics presentations among vaccine policymakers and researchers
John S. Richardson, Mark L. Messonnier, Lisa A. Prosser
Pages 6416-6423
Purpose
Measure the preferences of decision makers and researchers associated with the Advisory Committee on Immunization Practices (ACIP) regarding the recommended format for presenting health economics studies to the ACIP.

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

Journal of Global Oncology

1. 4_suppl_2 (October 1 2018)

Track 1 – Motivating Prevention and Healthy Behaviours
HPV Vaccination and Cervical Cancer Screening in Taiwan
MJ Chen, CY Wu, R Chen, YW Wang
Abstract
Background and context: Cervical cancer has been one of the most important cancers over the last 3 decades in Taiwan, and it still is among the top 10 cause of death for women. Aim: The aim of the policy was to achieving the following KPIs: HPV vaccine inoculation rate to 60%; 30-69 year Papanicolaou test screening rate ≥ 70%; and cervical cancer mortality dropped to 3.3/105 (baseline 1995 = 11/105). Strategy/Tactics: We provided annual Pap test for all women aged 30 years or more since 1995 and encourage women to screen at least every 3 years. We will introduce national HPV vaccination program for girls aged 13 years later this year. Program/Policy Process: We used a coordinated multichannel delivery system including clinical and community approaches that empower people to access services. The cost of treatment was covered by the universal health insurance. Our vaccination program started from whom are likely to have less access to screening later in life since 2011, and some cities/counties initiated their own vaccination program. Our national HPV vaccination aims to increase the inoculation rate to 60%. Outcomes: The standardized cervical cancer incidence rate decreased by 66%, from 25 per 100,000 in 1995 to 8.5 per 100,000 in 2014. The standardized mortality rate fell by 70% between 1995 and 2016, from 11 to 3.3 people per 100,000. In 2015, the total inoculation rate was about 38%. According to the Vaccine Adverse Effect Reporting System, the HPV vaccine is very safe. Among almost 820,000 doses inoculated from 2010 to 2016, the number of adverse effect was 2107 (0.25%). What was learned: The policy combined HPV vaccination and national Papanicolaou test screening strategies are successful. The implementation of the act, funding allocation, information system, health education to target population and medical staff as well as media advocacy, were keys to success.
 
 
Frontiers in Veterinary Science 
doi: 10.3389/fvets.2018.00259
Review Article
Efficacy and safety of BCG vaccine for control of tuberculosis in domestic livestock and wildlife
BM Buddle, HM Vordermeier, MA Chambers…
Bovine tuberculosis (TB) continues to be an intractable problem in many countries, particularly where “test and slaughter” policies cannot be implemented or where wildlife reservoirs of Mycobacterium bovis infection serve as a recurrent source of infection for domestic livestock. Alternative control measures are urgently required and vaccination is a promising option. Although the M. bovis bacille Calmette-Guérin (BCG) vaccine has been used in humans for nearly a century, its use in animals has been limited, principally as protection against TB has been incomplete and vaccination may result in animals reacting in the tuberculin skin test. Valuable insights have been gained over the past 25 years to optimise protection induced by BCG vaccine in animals and in the development of tests to differentiate infected from vaccinated animals (DIVA). This review examines factors affecting the efficacy of BCG vaccine in cattle, recent field trials, use of DIVA tests and the effectiveness of BCG vaccine in other domestic livestock as well as in wildlife. Oral delivery of BCG vaccine to wildlife reservoirs of infection such as European badgers, brushtail possums, wild boar and deer has been shown to induce protection against TB and could prove to be a practical means to vaccinate these species at scale. Testing of BCG vaccine in a wide range of animal species has indicated that it is safe and vaccination has the potential to be a valuable tool to assist in the control of TB in both domestic livestock and wildlife.

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 6 Oct 2018  
Science
A Controversial Virus Study Reveals a Critical Flaw in How Science Is Done
After researchers resurrected a long-dead pox, some critics argue that it’s too easy for scientists to make decisions of global consequence.
Ed Yong
Oct 4, 2018

BBC
http://www.bbc.co.uk/
Accessed 6 Oct 2018  
[No new, unique, relevant content]

 
The Economist
http://www.economist.com/
Accessed 6 Oct 2018  
[No new, unique, relevant content]

 
Financial Times
http://www.ft.com/home/uk
Accessed 6 Oct 2018  
[No new, unique, relevant content]

 
Forbes
http://www.forbes.com/
Accessed 6 Oct 2018
[No new, unique, relevant content]

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

Foreign Policy
http://foreignpolicy.com/
Accessed 6 Oct 2018  
Trump Stealthily Seeks to Choke Off Funding to U.N. Programs
| 2 October 2018
Leaked emails and behind-the-scenes battles show how the administration, after failing to slash congressional aid, used bureaucratic levers to stifle money flows.

The Guardian
http://www.guardiannews.com/
Accessed 6 Oct 2018
[No new, unique, relevant content]

 
New Yorker
http://www.newyorker.com/
Accessed 6 Oct 2018
[No new, unique, relevant content]

 
New York Times
http://www.nytimes.com/
Accessed 6 Oct 2018
Five New Ebola Cases Confirmed in Eastern Congo-Health Ministry
Oct. 6, 2018
KINSHASA — The Congolese health ministry on Saturday reported a further five confirmed cases of Ebola in the east of the Democratic Republic of Congo, blaming the higher-than-normal daily increase on community resistance to disease response efforts.
The current epidemic in Congo’s North Kivu and Ituri provinces has seen 140 confirmed cases since July, 108 of whom have died, according to the ministry’s daily bulletin, which has been reporting an average of one to two new confirmed cases per day in recent weeks.
The ministry said the five new cases were located in the regional hub of Beni, where attacks by rebel groups in the area and local mistrust of the Ebola response campaign have disrupted treatment and vaccination programmes.
“The town of Beni has become the new focus point of the disease, registering the highest percentage of cases reported in recent weeks following community resistance of certain families,” it said in a statement.

Polish Lawmakers Approve More Talks on Banning Vaccinations
By The Associated Press
Oct. 4, 2018
WARSAW, Poland — Lawmakers from Poland’s conservative ruling party have approved further parliamentary discussion over a controversial plan to abolish compulsory vaccinations for children, including those against serious diseases such as polio, measles, tuberculosis, rubella and whooping cough.
A civic group that proposed the plan argues that the vaccinations can be hazardous to small children and insists that parents should be allowed to refuse it.
The vaccinations are currently compulsory in Poland and the Health Ministry has warned that abolishing them would pose a threat to the health of individuals as well as the whole community.
Parliament’s lower house voted 252-158 with two abstentions Thursday to send the issue to parliamentary groups for further discussion.

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 6 Oct 2018
[No new, unique, relevant content]

Washington Post
http://www.washingtonpost.com/
Accessed 6 Oct 2018
[No new, unique, relevant content]
 

Think Tanks et al
 
Brookings
http://www.brookings.edu/
Accessed 6 Oct 2018
[No new relevant content]

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 6 Oct 2018
October 5, 2018
Ten Years of Aid Transparency – Fulfilling the Dream of Accra
Aid and development transparency has come a long way in ten years. In this, the first of a two-part blog series, we look back at the origins of the aid transparency movement. We reflect on the original vision of those who conceived the idea, and the journey to date including some of the successes achieved along the way.
Owen Barder and Gary Forster

CSIS
https://www.csis.org/
Accessed 6 Oct 2018
[No new relevant content]

Council on Foreign Relations
http://www.cfr.org/
Accessed 6 Oct 2018
[No new relevant content]

Milestones :: Perspectives
 
The Global Immunization Meeting: Successfully Navigating Transitions
[posted 24 Sep 2018]
In June, possibly the largest ever gathering of the immunization community took place in Kigali, Rwanda, co-hosted by WHO and UNICEF. From 26 to 28 June, the Global Immunization Meeting (GIM) was attended by over 250 participants representing key immunization stakeholders and partners at global, regional, and country levels.

Unlike past GIMs that covered key issues related to routine immunization strengthening, the implementation of new and under-utilized vaccines, and accelerated disease control efforts, the 2018 theme of the GIM was Navigating Transitions. This provided an opportunity to work toward a common understanding of current changes such as Gavi transition and polio transition, and to explore new directions for action as the Global Vaccine Action Plan comes to a close in 2020.

The meeting objectives were to:
:: Update global, regional, and country-level partners on key successes and challenges in immunization related to polio and Gavi transition
:: Provide a forum for formal and informal exchange of new ideas and innovations
:: Identify partner and country visions to achieve immunization programme goals after 2020.

The meeting consisted of a mix of multiple interactive session formats, providing many opportunities to engage and explore diverse aspects of immunization. The morning plenary sessions were dynamic and designed to challenge assumptions and bring new knowledge, and afternoon workshop sessions to provide an opportunity to explore technical topics in detail.

Short sessions also took place to introduce new content areas and to share the latest updates on key themes. Lastly, a range of special sessions, including debates and ‘breakfast with an expert’ offered the occasion to dive into specific ‘hot’ topics. For staying up-to-date on all of the action, a meeting app equipped all participants with the agenda, notifications, and an activity tracker for sharing alerts and photos.

With the excellent quality of content across the board, attendees participated actively throughout the meeting. It would be impossible to pin-point any specific sessions in particular, however it should be noted that the plenary presentations were particularly thought-provoking. Prof. Helen Rees kicked off the meeting with a compelling presentation on the global shifts affecting the future of immunization, and day 2 featured Ola and Anna Rosling challenging our preconceptions about demographics, demonstrating that we’re not always right (apparently!), and why trends in global health are actually better than we think.

Thank you to the planning committee for the learning, inspiration, and connections made throughout the meeting!

For further information and the meeting agenda, please see:
https://www.gim2018.org/
To view the plenary presentations from each day:
https://www.gim2018.org/video-and-photography/
 

Milestones :: Perspectives

Ebola – Democratic Republic of the Congo

Ebola virus disease – Democratic Republic of the Congo
Disease Outbreak News (DONs)  27 September 2018

The response to the Ebola virus disease (EVD) outbreak in the Democratic Republic of the Congo is at a critical juncture. While substantial progress has been made, the situation is precarious given recent increases in insecurity, incidents of community reluctance and geographical spread.

There have been a number of incidents in recent days, notably in Beni, which have led to loss of life among the local communities. WHO response activities have been severely limited as Beni and other towns mark a period of mourning for those who were killed. Security in Beni and other areas remains challenging.

The Ministry of Health (MoH), WHO and partners continue to work closely with people in the affected areas to overcome reluctance and mistrust which has developed among some communities. Rumours, misinformation and traditional practices have led some families to opt to care for sick relatives at home; some patients have also left health facilities to seek alternative care. Together this results in health workers being unable to provide optimal treatment, and also increases the risk of infection for relatives and local community members. These factors have contributed to the geographical spread of the outbreak.

The movement of several cases across health zones in recent weeks is concerning; one infected individual who recently moved to Kalunguta Health Zone is the first to move into a ‘red’ zone – highly insecure and challenging environments where implementing response activities is extremely difficult, if not impossible. Responders are employing a range of new techniques in these red zones, including using armed escorts and training local health workers to trace contacts.

Where they have access, response teams continue to enhance activities to prevent new clusters and the potential spread to new areas. WHO continues to work in the affected areas, side-by-side with national and international partners, to support the response led by the MoH. There continues to be challenges with identifying all contacts, registered contacts being lost to follow up, delayed recognition of EVD in health centres, poor infection prevention and control (IPC) in health centres, and reluctance among some cases to be treated in Ebola treatment centres (ETCs). The priority remains strengthening all components of the public health response in all affected areas, as well as continuing to enhance operational readiness and preparedness in the non-affected provinces of the Democratic Republic of the Congo and in neighbouring countries.

Since the last Disease Outbreak News (data as of 18 September), nine new confirmed EVD cases were reported: five from Beni, one from Butembo and one from Mabalako health zones in North Kivu Province, as well as two from Tchomia Health Zone in Ituri Province. These are the first confirmed EVD cases to be reported from Tchomia Health Zone which is near the Ugandan border; both cases, a couple, were linked to the ongoing Beni transmission chain. Two of the remaining seven cases have been linked to ongoing transmission chains within the respective communities, while the last five cases are under investigation.

As of 25 September 2018, a total of 151 EVD cases (120 confirmed and 31 probable), including 101 deaths (70 confirmed and 31 probable)1, have been reported in seven health zones in North Kivu Province (Beni, Butembo, Kalunguta, Mabalako, Masereka, Musienene and Oicha), and two health zones in Ituri Province (Mandima and Tchomia) (Figure 1). An overall decreasing trend in weekly case incidence continues (Figure 2); however, these trends must be interpreted with caution given the expected delays in case reporting, the ongoing detection of sporadic cases and the security situation which is limiting contact tracing. Of the 149 confirmed and probable cases for whom age and sex information is known, 23%, 20% and 22% are aged 15-24, 25-34 and 35-44 years, respectively; females (56%) accounted for the greatest proportion of cases (Figure 3). Cumulatively, 19 (18 confirmed and one probable) health workers have been affected to date, three of whom have died.

The MoH, WHO and partners continue to closely monitor and investigate all alerts in affected areas, in other provinces in the Democratic Republic of the Congo and in neighbouring countries. As of 25 September, 17 suspected cases in the Democratic Republic of the Congo are awaiting laboratory testing. Since the last report was published, alerts were investigated in several provinces of the Democratic Republic of the Congo, as well as in neighbouring countries; and to date, EVD has been ruled out in all alerts from neighbouring provinces and countries.

:: 08: Situation report on the Ebola outbreak in North Kivu  25 September 2018

::::::

 
WHO calls for protection of humanitarian workers and civilians in Democratic Republic of the Congo
26 September 2018  News Release
The response to the outbreak of Ebola in North Kivu and Ituri provinces in the Democratic Republic of the Congo is at a critical juncture, threatened by worsening insecurity, mistrust from affected communities, and extension into previously unaffected areas…

But there is a risk now that hard-won gains may be lost.
First, there has been an increase in frequency and severity of attacks by armed opposition groups. Attacks by armed opposition groups on the town Beni, in North Kivu, where the Ministry of Health and partners have based their response, have occurred with alarming frequency. Most recently a deadly attack on 22 September left 21 dead, including 17 civilians.

As a result, WHO and its UN partners were asked to halt operations in Beni, while the city mourns its dead. As of today, some operations have begun to resume, but even a gap of two days has resulted in health workers not being able to reach contacts of Ebola patients to monitor their health; or investigate alerts of potential cases.

Meanwhile, some families have chosen to care for sick relatives at home, often because they have been misinformed, and because a natural fear of the disease is now being exploited by local politicians.

Others sick with Ebola travel widely to seek alternative care, putting themselves, their families and health workers at risk. This has brought infection to new locations, where teams cannot provide them with access to treatment, or provide protective vaccines to their contacts.  These include security red zones which are difficult to access, and to areas bordering Uganda.

WHO calls on all relevant parties, and the governments or groups that have influence over these parties, to help protect responders and civilians.

WHO also calls on governments in surrounding countries to accelerate the preparedness activities which they have begun, with WHO support, to ensure a level of readiness should they face cases of Ebola themselves.

::::::

UNICEF teams up with Ebola survivors to help stop spread of deadly outbreak in the Democratic Republic of the Congo

KINSHASA/DAKAR/NEW YORK/GENEVA, 28 September 2018 – Recent survivors of the Ebola virus and UNICEF are partnering to help prevent further transmission of the deadly disease in the eastern Democratic Republic of the Congo (DRC). As part of this effort, the survivors are sharing their stories during public events and through public radio in Ebola-affected communities.

Forty-three people have survived the Ebola virus since the beginning of the latest outbreak in August.

“The survivors are living proof that it is possible to recover from the Ebola virus disease, especially if it is detected and treated early,” said Dr. Gianfranco Rotigliano, UNICEF Representative in the DRC. “The testimonies of these Ebola-survivors help us to reduce the fear in the communities and to encourage people with Ebola-like symptoms to look for early treatment, thereby avoiding the risk of further contamination.”

Lack of awareness of prevention measures and treatment of the disease among the population increases the risk of further transmission, as shown by the newly confirmed case of Ebola in the Tchomia health zone. In response to this case, UNICEF has deployed a team to help with the Ebola-response put in place by the Government and now has response teams operating in Mangina, Beni, Butembo and Tchomia…

Milestones :: Perspectives

TB: Commitments/Vaccines/Strategies

World leaders commit to bold targets and urgent action to end TB

26 September 2018  News Release

World leaders meeting today at the United Nations (UN) General Assembly have committed to ensure that 40 million people with tuberculosis (TB) receive the care they need by end 2022. They also agreed to provide 30 million people with preventive treatment to protect them from developing TB.

“Today is a landmark in the long war on TB,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “These are bold promises – to keep them partnership is vital. WHO is committed to working with every country, every partner and every community to get the job done.”

Heads of state and government attending this first-ever UN High-level meeting on TB agreed to mobilize US$ 13 billion a year by 2022 to implement TB prevention and care, and US$ 2 billion for research. They committed to take firm action against drug-resistant forms of the disease; build accountability and to prioritize human rights issues such as the stigma that still prevails around TB in many parts of the world.

They acknowledged that the current rate of progress was endangering prospects of meeting global targets to end TB. Today, TB remains the world’s deadliest infectious disease: it killed 1.6 million people in 2017, including 300 000 people with HIV. In the same year, 10 million people fell ill with TB.

“The political declaration proposed for this meeting sets a roadmap for accelerated action to end TB in line with the vision and targets for 2030,” said H.E. Ms Maria Fernanda Espinosa Garcés, President of the 73rd Session of the UN General Assembly. “We have before us the opportunity for a clear win – a chance to save the lives of millions, to preserve billions in resources, to demonstrate the success of the Sustainable Development Goals, and to reaffirm the utility, efficacy and necessity of multilateralism and the UN System. Let us not miss this opportunity.”

The political declaration is the culmination of recent leadership commitments at global and regional level – including the 2017 Moscow Declaration to End TB – to drive universal access, sufficient and sustainable financing, intensified research and innovation, and accountability across all sectors.

::::::

GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults in phase II study

Publication of primary results in the New England Journal of Medicine shows positive impact of innovative vaccine technology in clinical trial conducted in tuberculosis endemic regions

LONDON (25 September 2018) – Today, GSK and Aeras reported that GSK’s M72/AS01E[1] candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection[2] in an ongoing phase IIb clinical trial testing. These primary results published in the New England Journal of Medicine after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.

Tuberculosis is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.6 million attributed deaths in 2017. It is estimated that one-quarter of the global population has latent tuberculosis infection, of whom approximately 10% will develop active pulmonary tuberculosis disease.  Currently, multi-drug resistant strains of tuberculosis are emerging globally, and the only currently available vaccine against tuberculosis, BCG, does not provide proven and consistent protection in adults in tuberculosis endemic countries. Without a more effective vaccine, it will not be possible to achieve the WHO target of decreasing the number of new cases by 90% and the number of tuberculosis deaths by 95% between 2015 and 2035.

Dr Emmanuel Hanon, Senior Vice-President and Head of R&D, Global Vaccines GSK, said: “These initial findings represent a significant innovation in the development of a new and much-needed vaccine and advance the scientific understanding of tuberculosis. This scientific breakthrough – one of the very few in tuberculosis vaccine development for almost 100 years – has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant.”

The study assesses the safety and efficacy of M72/AS01E protecting adults with latent tuberculosis infection against developing pulmonary tuberculosis disease. The ongoing trial is conducted in tuberculosis endemic regions (Kenya, South Africa and Zambia) and involves 3,573 HIV-negative adults. For this analysis, participants who received two doses of either M72/AS01E or placebo 30 days apart have been followed up for at least 2 years to detect evidence of pulmonary tuberculosis disease.  In the vaccine group, 10 participants developed active pulmonary tuberculosis compared to 22 participants in the placebo group.

Jacqui Shea, Chief Executive Officer of Aeras, which contributed to the partnership their decades long experience in tuberculosis vaccine clinical development, clinical operations capabilities and strong links with African clinical sites and patient communities, said: “This ground-breaking study shows – for the first time – that a subunit vaccine can significantly reduce the incidence of pulmonary tuberculosis in healthy, HIV-negative adults with latent tuberculosis infection, and that more effective vaccines against tuberculosis are achievable. Given the overwhelming public health need, the importance of these promising results, which need to be confirmed through additional clinical research, cannot be overstated. An effective vaccine, able to reduce transmission, would be by far the most impactful new intervention to end the global tuberculosis epidemic”.

The study is still ongoing and a final analysis including all efficacy, safety, reactogenicity and immunogenicity data will be performed in 2019 after all participants have completed three years of follow up.

::::::
 
NIH releases strategic plan to address tuberculosis research

September 26, 2018 — TB is the leading infectious cause of death worldwide.
Recently, the global health community has strengthened its efforts and resolve to tackle this ancient disease. Writing in the Journal of the American Medical Association, Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s new strategic plan for building on these current efforts by furthering the understanding of TB and developing and applying cutting-edge tools to fight the disease.

The NIAID Strategic Plan for Tuberculosis Research prioritizes expanding fundamental knowledge of TB by using modern tools, such as state-of-the-art imaging and systems biology methods, to better understand how TB infection remains latent in some individuals and then progresses to active disease, as well as the host and microbial factors that affect TB disease, transmission, and epidemiology.  The plan is being released to coincide with the United Nations General Assembly High-Level Meeting on Ending TB on September 26…
 

Milestones :: Perspectives

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
September 28, 2018
“By modernizing our approach to the design of clinical trials, we can make drug development more efficient and less costly while also increasing the amount of information we can learn about a new product’s safety and benefits. Using more modern approaches to clinical trials, we can lower the cost of developing new drugs and increase the amount of competition in the market,” said FDA Commissioner Scott Gottlieb, M.D. “This can improve patient access. We’ve found that it’s taking much longer after a new drug is approved to get a second or third drug to the market that’s in the same class as the original medicine. That means that new drugs are enjoying monopolies for longer periods of time, and consumers aren’t benefiting from price competition. Also, patients aren’t getting the benefits from a choice between different drugs in a new class of medicines, where each drug is similar but might have slightly different profiles, and where one drug may work better for an individual patient. One of the most promising ways to make drug development more efficient — while enabling providers and patients to get better information about how a new medicine works — is through the use of more modern approaches to the design of clinical trials.

One such approach are master protocol designs. These are clinical trials that allow the evaluation of more than one investigational drug or biologic, more than one disease type, or more than one patient population in parallel, under a single clinical trial structure. The standard approach to generating evidence — a series of clinical trials, each investigating one or two interventions in a single disease — has become more expensive and challenging to execute. As a result, important clinical questions can go unanswered. Instead, well-designed master protocols that look at multiple therapies in a single disease, a single therapy in multiple diseases, or multiple therapies across multiple diseases or disease subtypes, can provide answers more quickly and efficiently than traditional clinical trials. These approaches allow the evaluation of how different drugs, often developed by different manufacturers, affect a common biomarker or genetic mutation that might be a measure of response to treatment. Because of the complexity of these trials and the potential regulatory impact, it’s important that we’re providing adequate guidance on how to conduct well designed trials that protect patient safety and obtain quality data needed to support drug approval. With the two new draft guidance documents being issued today – one on master protocols and one on adaptive clinical trial design – the FDA is proposing important principles for modernizing clinical trials through these and similar approaches.

Adaptive clinical trials can give sponsors the flexibility to react to clinical evidence as it’s being collected, and modify the design and enrollment in trials by including more patients with characteristics that help predict that they’re more likely to derive a benefit. Or exclude patients with characteristics that suggest that they’re more likely to suffer a side effect. By enriching the enrollment in the trial for patients with characteristics that are likely to predict clinical success, it has the potential to make the development process more efficient. This approach also allows us to potentially learn much more about the characteristics that can inform safer prescribing. All of these efforts are part of our broader program to modernize the FDA’s science-based framework for making clinical trials more efficient and lower cost while strengthening the agency’s gold standard for safety and efficacy.”

Today, the U.S. Food and Drug Administration is announcing two new draft guidances for industry. The first document, “Master Protocols – Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics,” addresses master protocol design. This includes a discussion of the information sponsors should submit to the FDA as part of these approaches, and how sponsors should interact with FDA to facilitate efficient review and mitigate risks to patients.

The second draft guidance is titled “Adaptive Designs for Clinical Trials of Drugs and Biologics,” addresses principles for designing, conducting and reporting the results from an adaptive clinical trial. An adaptive design is a type of clinical trial design that allows for planned modifications to one or more aspects of the design based on data collected from the study’s subjects while the trial is ongoing. The advantage of an adaptive design is the ability to use information that was not available at the start of the trial to improve efficiency. An adaptive design can provide a greater chance to detect the true effect of a product, often with a smaller sample size or in a shorter timeframe. Additionally, an adaptive design can reduce the number of patients exposed to an unnecessary risk of an ineffective investigational treatment. Patients may even be more willing to enroll in these types of trials, as they can increase the probability that subjects will be assigned to the more effective treatment.

These guidance documents are part of the FDA’s science-based mission to modernize clinical trials and advance the development of safe and effective drugs and biologics for the American public.

FDA has published a 60-day notice requesting public comment on these guidances. To comment, please see these links:

Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry
 

Adaptive Designs for Clinical Trials of Drugs and Biologics; Draft Guidance for Industry

Emergencies

 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 25 September 2018 [GPEI]
:: Featured on www.polioeradication.org: Coffee with Polio Experts – Head of WHO Chad Dr Jean-Bosco Ndihokubwayo speaks about the ongoing efforts to reach every child with polio vaccine across Chad.
Summary of new viruses this week:
Afghanistan – – two new wild poliovirus type 1 (WPV1) positive environmental samples; Pakistan – five new WPV1-positive environmental samples;
Nigeria – three cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) and two cVDPV2-positive environmental samples;
Niger – two cVDPV2 cases;
Horn of Africa (Somalia) – three cVDPV3 cases and one cVDPV3 positive environmental sample; and,
Papua New Guinea – two new cVDPV1 cases.
 
::::::
::::::
 
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 29 Sep 2018]
Bangladesh – Rohingya crisis
:: Weekly Situation Report 44 -19 September 2018 pdf, 281kb

Democratic Republic of the Congo
:: 08: Situation report on the Ebola outbreak in North Kivu  25 September 2018
:: Disease Outbreak News (DONs)  Ebola virus disease – Democratic Republic of the Congo
27 September 2018
[See Milestones above for detail]

Syrian Arab Republic
:: The only tuberculosis control centre in Aleppo is up and running again  26 September 2018

Yemen
:: High-Level Event on the Humanitarian Response in Yemen
Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization
United Nations General Assembly, 24 September 2018

Nigeria – No new announcements identified
Somalia – No new announcements identified
South Sudan – No new announcements identified

::::::
 
WHO Grade 2 Emergencies  [to 29 Sep 2018]
Myanmar
:: Weekly Situation Report 44 -19 September 2018
 
Zimbabwe
:: WHO is scaling up response to a fast-moving cholera outbreak in Zimbabwe’s capital
Harare/Brazzaville 13 September 2018 – The World Health Organization (WHO) is scaling up its response to an outbreak of cholera in Zimbabwe, which is expanding quickly in Harare, the country’s capital with a population of more than two million people…

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
Iraq – No new announcements identified
occupied Palestinian territory – No new announcements identified
Libya – No new announcements identified
MERS-CoV – 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: 15 -21 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 Niger
:: Cholera outbreak in Zimbabwe
:: Cholera outbreak in Chad
:: Cholera outbreak in Nigeria

::::::
 
WHO Grade 1 Emergencies  [to 29 Sep 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. 
Syrian Arab Republic   – No new announcements identified.
Yemen  – 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  – No new announcements identified.
Somalia   – No new announcements identified.

::::::
::::::
 
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 29 Sep 2018]
http://www.who.int/ebola/en/
[See Milestones above for more detail]

MERS-CoV [to 29 Sep 2018]
http://who.int/emergencies/mers-cov/en/
– No new announcements identified.
 

Yellow Fever  [to 29 Sep 2018]
http://www.who.int/csr/disease/yellowfev/en/
:: The Republic of Congo to vaccinate more than one million people against yellow fever
26 September 2018, Brazzaville – The Republic of Congo, in collaboration with the World Health Organization (WHO) and partners started today a vaccination campaign to control the spread of yellow fever in the port city of Pointe Noire and surrounding areas. More than 1 million people from nine months of age are expected to be vaccinated in this six-day campaign.
The vaccination campaign uses doses from the global emergency Yellow Fever vaccine stockpile managed by the International Coordination Group on Vaccine Provision (ICG) and funded by Gavi, the Vaccine Alliance. The ICG coordinates the timely and equitable provision of vaccines during outbreaks and maintains an emergency stockpile of six million doses of yellow fever vaccine, which is continually replenished. Gavi will also cover operational costs for this campaign.
The immunization drive is a response to a laboratory-confirmed yellow fever case, which tested positive on 21 August 2018, after visiting a rural area…

Zika virus  [to 29 Sep 2018]
http://www.who.int/csr/disease/zika/en/
– No new announcements identified.

WHO & Regional Offices [to 29 Sep 2018]

The Global Immunization Meeting
26 – 28 June 2018 [posted 24 September 2018]
[See Milestones above for detail]

World Rabies Day 2018
28 September 2018 | Geneva –– In 2015, the world called for action by setting a goal of zero human dog-mediated rabies deaths by 2030, worldwide. World Rabies Day provides a platform to improve awareness, engage communities and help endemic countries in building successful and sustainable rabies programmes.
Awareness and education are vital to the success of the rabies zero by 30 campaign. Through education we can improve the health, wellbeing and development of communities and save thousands of lives each year.

27 September 2018   News Release
Heads of State commit to lead response to beat noncommunicable diseases, promote mental health

27 September 2018  News Release
WHO Director-General reappoints Michael R. Bloomberg as WHO Global Ambassador for Noncommunicable Diseases and Injuries

26 September 2018  News Release
WHO calls for protection of humanitarian workers and civilians in Democratic Republic of the Congo
[See Milestones above for detail]

26 September 2018  News Release
World leaders commit to bold targets and urgent action to end TB
[See Milestones above for detail]

26 September 2018  News Release
Ray Chambers appointed WHO Ambassador for Global Strategy
::::::
 
Weekly Epidemiological Record, 28 September 2018, vol. 93, 39 (pp. 500–520)
:: Progress towards poliovirus containment worldwide, 2017–2018
:: Summary of global update on provision of preventive chemotherapy in 2017 and progress towards ensuring timely supplies and management
::::::
 

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
Selected Featured News
:: From high burden to high impact: getting back on track to end malaria  29 September 2018
:: Uganda steps up Ebola preparedness response in 22 high-risk districts  27 September 2018
:: Yobe State requests WHO’s expertise over fresh cholera outbreak  27 September 2018
:: WHO deploys nearly 4,000 volunteers to tackle malaria in Borno and Adamawa States
27 September 2018
:: The Republic of Congo to vaccinate more than one million people against yellow fever
26 September 2018
:: WHO scales up new front against Ebola in the Democratic Republic of Congo, near the border with Uganda  26 September 2018
:: WHO Supports Training of 450 Community Health Volunteers to Enhance Community Case Detection  24 September 2018

WHO Region of the Americas PAHO
:: PAHO Directing Council ends with agreements to reduce the shortage of health personnel and prevent diseases in the Region (09/27/2018)
:: Actions agreed to improve the health of women, children and adolescents across their life course (09/27/2018)
:: Bioethics must be strengthened in the Region to better prepare for public health emergencies (09/26/2018)
:: Ministers of health commit to reducing cervical cancer cases and deaths by 30% in the Americas by 2030 (09/26/2018)
:: PAHO: No cases of poliomyelitis have been reported in the Region of the Americas since 1991 (09/26/2018)
:: Road safety is improving, but more laws are required to control speed limits, helmet and seat belt use in the Americas (09/26/2018)
:: Countries in the Americas can end preventable child mortality by reaching the most vulnerable (09/26/2018)
:: New PAHO plan aims to reduce a shortage of nearly 800,000 health workers in the Region of the Americas (09/26/2018)
:: Progress must be accelerated to end tuberculosis in the Americas, says new PAHO report (09/25/2018)
:: Ministers of Health of the Americas agree to strengthen actions to prevent vector-borne diseases (09/24/2018)
:: Uruguayan President and pioneer in tobacco control is named a PAHO Health Hero of the Americas (09/24/2018)
:: New challenges threaten health achievements in the Americas and call for innovative solutions  (09/23/2018)
 

WHO South-East Asia Region SEARO
:: EU grant to improve health services for more than one million vulnerable people
SEAR/PR/1701   Dhaka, 25 September: A European Union grant of €1 million (US$1.2 million) is helping the World Health Organization to strengthen health services for the nearly one million vulnerable Rohingyas and their host communities in Cox’s Bazar, Bangladesh, who remain at risk of disease outbreaks.
 

WHO European Region EURO
::  Groundbreaking pledge of United Nations agencies to end HIV, TB and viral hepatitis epidemics in Europe at high-level meeting on ending TB 28-09-2018
:: Adolescents drink less, although levels of alcohol consumption are still dangerously high 26-09-2018
:: Multisectoral action to promote physical activity has increased in the EU 24-09-2018 
:: WHO School on Refugee and Migrant Health to build on existing capacities for providing care 24-09-2018

WHO Eastern Mediterranean Region EMRO
:: Tuberculosis control centre reopens in Aleppo  26 September 2018

WHO Western Pacific Region
-No new announcement identified

CDC/ACIP [to 29 Sep 2018]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for September 27, 2018
Influenza Vaccination Coverage Among Health Care Personnel — United States, 2017–18 Influenza Season
CDC, the Advisory Committee on Immunization Practices (ACIP), and the Healthcare Infection Control Practices Advisory Committee recommend that all healthcare workers get an annual flu vaccine. If you work in health care and get the flu, you can spread it to others even if you don’t feel sick. By getting vaccinated, you help protect yourself, your family at home, and your patients. CDC, ACIP, and the Healthcare Infection Control Practices Advisory Committee recommend all health care workers receive an annual flu vaccine. Vaccinating healthcare workers can a) reduce influenza-related morbidity and mortality among health care workers, b) reduce work absences, and c) help protect patients. Flu vaccination coverage during the 2017-2018 flu season was 78.4 percent among healthcare workers, which is a 15 percentage-point increase from the 2010-2011 flu season. However, estimates have stayed relatively similar during the past four seasons. Coverage was consistently higher among healthcare workers in hospital settings and lowest among healthcare workers in long-term-care settings.

Influenza and Tdap Vaccination Coverage Among Pregnant Women — United States, April 2018 
Many pregnant women are unvaccinated. They and their babies continue to be vulnerable to influenza and pertussis infections with potentially serious complications including hospitalization and death. Doctors are encouraged to strongly recommend vaccines that their pregnant patients need, and either administer needed vaccines or refer patients to a vaccination provider. CDC and the Advisory Committee on Immunization Practices (ACIP) recommend two vaccines for pregnant women: 1) a flu vaccine for women who are or might be pregnant during the flu season and 2) a Tdap (tetanus, diphtheria, and acellular pertussis) vaccine during every pregnancy, between 27 and 36 weeks gestation (preferably earlier in this period). To assess influenza and Tdap vaccination coverage among pregnant women during the 2017–18 influenza season, CDC analyzed data from an Internet panel survey. Only about half (49.1 percent) of women reported receiving influenza vaccine before or during their pregnancy. Additionally, a little over half (54.4 percent) reported receiving Tdap during their pregnancy. Women who reported receiving a provider offer of vaccination had higher vaccination coverage than women who received a recommendation but no offer and women who did not receive a recommendation.

Meningococcal Disease Surveillance in Men Who Have Sex with Men — United States, 2015–2016
Men who have sex with men (MSM), including those with HIV, have increased meningococcal disease rates compared to non-MSM. Identifying MSM among meningococcal disease patients and improving collection of data on HIV status for all cases will help researchers understand the epidemiology and risk factors for meningococcal disease among MSM. Studies have shown that MSM are at increased risk for meningococcal disease in the United States. However, until now, researchers have not well described the epidemiology of disease in this group because gender of sex partners and/or sexual orientation have not historically been collected through routine meningococcal disease surveillance. From 2015-2016, 271 meningococcal disease cases were reported in men ages ≥18 years; among them, sufficient information to identify MSM status was available for 124 (45.8 percent). Overall, 48 (17.7 percent) cases occurred in MSM. MSM, including those with HIV, have increased meningococcal disease rates compared to non-MSM. During investigations of meningococcal disease, CDC encourages state and local health departments to assess HIV status of all patients and identify MSM among male patients ages ≥16 years.

Barriers to Receipt of Prenatal Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) Among Mothers of Infants Aged <4 Months with Pertussis — California, 2016
Getting immunized against whooping cough at the earliest opportunity during 27-36 weeks gestation of each pregnancy is the best way to protect young infants against this disease. Prenatal care providers should make a strong recommendation for Tdap to all pregnant women. If Tdap is not stocked onsite, providers should make every effort to refer patients to an accessible site covered by the mother’s insurance and then follow up to ensure she is immunized. Infants are at highest risk for hospitalization and death due to whooping cough (pertussis). To protect newborns, CDC recommends that all pregnant women be immunized against whooping cough as early as possible during 27-36 weeks gestation of each pregnancy. This California study showed that only 30 percent of mothers whose infants developed pertussis were appropriately vaccinated. Women whose prenatal clinics stocked Tdap vaccine were more likely to be vaccinated. Women with Medicaid insurance were less likely to be vaccinated than were those with private insurance, even when treated in clinics that stocked Tdap vaccine.

Africa CDC   [to 29 Sep 2018]

https://au.int/en/africacdc
October 01, 2018 to October 02, 2018
Africa CDC Workshop on “One Health in East Africa”

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.