The scientists’ apprentice

Science         
07 July 2017  Vol 357, Issue 6346
http://www.sciencemag.org/current.dtl
Special Issue – The cyberscientist
Introduction to special issue

The scientists’ apprentice
Tim Appenzeller
Summary
Big data has met its match. In field after field, the ability to collect data has exploded, overwhelming human insight and analysis. But the computing advances that helped deliver the data have also conjured powerful new tools for making sense of it all. In a revolution that extends across much of science, researchers are unleashing artificial intelligence (AI), often in the form of artificial neural networks, on these mountains of data. Unlike earlier attempts at AI, such “deep learning” systems don’t need to be programmed with a human expert’s knowledge. Instead, they learn on their own, often from large training data sets, until they can see patterns and spot anomalies in data sets far larger and messier than human beings can cope with.

Marketing of unproven stem cell–based interventions: A call to action

Science Translational Medicine
05 July 2017  Vol 9, Issue 397
http://stm.sciencemag.org/

Perspective
Marketing of unproven stem cell–based interventions: A call to action
By Douglas Sipp, Timothy Caulfield, Jane Kaye, Jan Barfoot, Clare Blackburn, Sarah Chan, Michele De Luca, Alastair Kent, Christopher McCabe, Megan Munsie, Margaret Sleeboom-Faulkner, Jeremy Sugarman, Esther van Zimmeren, Amy Zarzeczny, John E. J. Rasko
Science Translational Medicine05 Jul 2017 Restricted Access
Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that should be addressed by coordinated approaches at the national and international levels.

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

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

The Journal of Infection in Developing Countries
Vol 11 No 06: June 2017
Immune response to hepatitis B vaccine among north Iranian healthcare workers and its related factors
F Joukar, F Mansour-Ghanaei, MR Naghipour…
Abstract
Introduction: Hepatitis B virus (HBV) is an important occupational risk among healthcare workers (HCWs). Vaccination is the most cost-effective method of preventing and controlling HBV infection. Several factors have been suggested to effect response to the vaccine. The present study aimed to evaluate vaccine response among north Iranian HCWs and to determine the factors influencing vaccine response.
Methodology: Response to the standard three-dose vaccination regimen was evaluated in term of anti-hepatitis B surface antigen level among 1,010 HCWs using an enzyme-linked immunosorbent assay (ELISA) method. Logistic regression was applied to predict antibody response, with related factors including sex, age, years of working experience, marital status, history of transfusion, smoking, history of needle stick injury, rheumatic disease, steroid use, and elapsed time from vaccination measurement.
Results: Of the 1,010 HCWs, 898 (88.9%) acquired protective levels of antibody (> 10 IU/mL). Compared with those < 30 years of age, HCWs older than 50 years and between 40 and 50 years of age were more likely to have non-protective anti-HBs levels (odds ratio=4.48; p=0.001 and odds ratio=1.85; p=0.03, respectively).
Conclusions: HBV vaccine efficacy and immune response were satisfactory among north Iranian HCWs. Since it is predicted that anti-HBs levels decrease with aging, testing for anti-HBs titer is desirable for HCWs older than 50 years of age.

Media/Policy Watch

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

 

Forbes
http://www.forbes.com/
Accessed 8 July 2017
Vaccine Liability And Causation: Has Europe Gone Overboard?
Jul 6, 2017
Michael I. Krauss, Contributor
A very recent decision by the European Court of Justice gives pause to all who believe that causation must be proven in order to recover in tort. I here discuss the decision and its implications.

New York Times
http://www.nytimes.com/
Accessed 8 July 2017
UN Health Agency’s New Chief Says He Will Check Travel Costs
The new head of the World Health Organization said he is reviewing the agency’s travel expenses, after an Associated Press story revealed the U.N. agency spends more on travel than on fighting AIDS, malaria and tuberculosis combined.
July 07, 2017 – By THE ASSOCIATED PRESS

Cholera Spreads as War and Poverty Batter Yemen
By SHUAIB ALMOSAWA and NOUR YOUSSEF
JULY 7, 2017
Since a severe outbreak began in late April, according to Unicef, cholera has spread to 21 of the country’s 22 provinces, infecting at least 269,608 people and killing at least 1,614. That is more than the total number of cholera deaths reported to the World Health Organization worldwide in 2015.

Washington Post
http://www.washingtonpost.com/
Sudanese doctors urge measures against cholera outbreak
Sudan’s affected areas and helping the government vaccinate against cholera, says the response to cholera
Brian Rohan | AP · Foreign · Jul 2, 2017

Think Tanks et al

Think Tanks et al

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 8 July 2017
Publications
What’s In, What’s Out: Designing Benefits for Universal Health Coverage
7/3/17
What’s In, What’s Out: Designing Benefits for Universal Health Coverage argues that the creation of an explicit health benefits plan—a defined list of services that are and are not available—is an essential element in creating a sustainable system of universal health coverage. With contributions from leading health economists and policy experts, the book considers the many dimensions of governance, institutions, methods, political economy, and ethics that are needed to decide what’s in and what’s out in a way that is fair, evidence-based, and sustainable over time.

Vaccines and Global Health: The Week in Review 1 July 2017

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

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

 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_1 July 2017

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

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

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

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

Milestones :: Perspectives

Milestones :: Perspectives

Editor’s Note:
Dr Tedros Adhanom Ghebreyesus assumes the Director General role today [1 July 2017]. WHO posted the vision statement below:

Vision statement by WHO Director-General
I envision a world in which everyone can live healthy, productive lives, regardless of who they are or where they live.

A world in which everyone can live healthy, productive lives
I envision a world in which everyone can live healthy, productive lives, regardless of who they are or where they live. I believe the global commitment to sustainable development – enshrined in the Sustainable Development Goals – offers a unique opportunity to address the social, economic and political determinants of health and improve the health and well-being of people everywhere.
Achieving this vision will require a strong, effective WHO that is able to meet emerging challenges and achieve the health objectives of the Sustainable Development Goals. We need a WHO – fit for the 21st century – that belongs to all, equally. We need a WHO that is efficiently managed, adequately resourced and results driven, with a strong focus on transparency, accountability and value for money.

Putting people first
The right of every individual to basic health services will be my top priority. I will champion mechanisms to meaningfully listen to, learn from and engage people and communities – including migrant, displaced and disabled individuals; people living in rural, urban slum and low-income areas; and other vulnerable populations.
This engagement – and what we learn from it – will be at the centre of our efforts to mobilize resources and hold authorities accountable for the health of all, regardless of age, gender, income, sexual orientation or religion.

Placing health at the centre of the global agenda
When people are healthy, entire communities and nations thrive – indeed, the whole world benefits. I will engage with Heads of State, Ministers across a wide range of portfolios, multilateral institutions, the UN system, civil society and the private sector to make access to health care and protection from infectious disease outbreaks a central component of the world’s security, economic and development agendas.
This will include implementing the International Health Regulations and addressing emerging threats, such as antimicrobial resistance, climate and environmental change and non-communicable diseases. Such engagement will enable WHO and national health authorities to effectively perform their core functions, reaffirm WHO’s leadership in securing a healthier and safer world, and ultimately drive progress towards the Sustainable Development Goals.

Engaging countries and strengthening partnerships
Improving global health requires effective engagement with all Member States and across multiple sectors. Under my leadership an enhanced and independent WHO will take a science-led and innovation-based approach that is results-oriented and responsive, maximises inclusive partnerships, and ensures collective priority setting with all stakeholders. In particular, I will champion country ownership, so that countries are at the table, as full and equal partners, to guide and make the decisions that will affect the health of their populations.
WHO’s work touches hundreds of millions of lives around the world. Every programme, every initiative, every allocation of funding is so much more than a statistic or line in a budget. It is a life protected. It is a child who gets to see adulthood. It is a parent who watches their child survive and thrive. It is a community living disease free or an entire country or region that is better prepared for emergencies or disasters. This is the difference WHO can make, working hand-in-hand with Member States and global partners.
 
WHO Priorities
WHO posted brief overviews describing these priorities, each led by a quotation from Dr. Tedros as below.
:: Health for all
   The right of every individual to basic health services will be my top priority – Dr Tedros
:: Health emergencies
   I will engage with diverse stakeholders to make health care and protection from infectious
   disease outbreaks a central component of the world’s security, economic and social
   development agendas. – Dr Tedros
:: Women, children and adolescents
   I believe healthy, empowered girls and women have the potential to build stronger
   communities, and nations and ultimately transform entire societies – Dr Tedros
:: The health impacts of climate and environmental change
   Developing and nurturing resilient and effective community based structures and multi-
   sectoral approaches is critical to prevent, mitigate and respond to the health impacts of
   environmental risk factors and climate change. – Dr Tedros
:: A transformed WHO
  Thanks to the actions of WHO, more people are living longer, healthier lives than ever before.
   However, we live in a changing world, and WHO must be able to change with it. – Dr Tedros

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World Bank Launches First-Ever Pandemic Bonds to Support $500 Million Pandemic Emergency Financing Facility
[Editor’s text bolding]
Washington, DC, June 28, 2017 – The World Bank (International Bank for Reconstruction and Development) today launched specialized bonds aimed at providing financial support to the Pandemic Emergency Financing Facility (PEF), a facility created by the World Bank to channel surge funding to developing countries facing the risk of a pandemic.

This marks the first time that World Bank bonds are being used to finance efforts against infectious diseases, and the first time that pandemic risk in low-income countries is being transferred to the financial markets.

The PEF will provide more than $500 million to cover developing countries against the risk of pandemic outbreaks over the next five years, through a combination of bonds and derivatives priced today, a cash window, and future commitments from donor countries for additional coverage.

The transaction, that enables PEF to potentially save millions of lives, was oversubscribed by 200% reflecting an overwhelmingly positive reception from investors and a high level of confidence in the new World Bank sponsored instrument. With such strong demand, the World Bank was able to price the transaction well below the original guidance from the market. The total amount of risk transferred to the market through the bonds and derivatives is $425 million.

“With this new facility, we have taken a momentous step that has the potential to save millions of lives and entire economies from one of the greatest systemic threats we face,” World Bank Group President Jim Yong Kim said. “We are moving away from the cycle of panic and neglect that has characterized so much of our approach to pandemics. We are leveraging our capital market expertise, our deep understanding of the health sector, our experience overcoming development challenges, and our strong relationships with donors and the insurance industry to serve the world’s poorest people. This creates an entirely new market for pandemic risk insurance. Drawing on lessons from the Ebola Outbreak in West Africa, the Facility will help improve health security for everyone. I especially want to thank the World Health Organization and the governments of Japan and Germany for their support in launching this new mechanism.”

The World Bank announced the creation of the PEF in May 2016 at the G7 Finance Ministers and Central Governors meeting in Sendai, Japan. The PEF will quickly channel funding to countries facing a major disease outbreak with pandemic potential. Its unique financing structure combines funding from the bonds issued today with over-the-counter derivatives that transfer pandemic outbreak risk to derivative counterparties. The structure was designed to attract a wider, more diverse set of investors.

The PEF has two windows. The first is an ‘insurance’ window with premiums funded by Japan and Germany, consisting of bonds and swaps including those executed today. The second is a ‘cash’ window, for which Germany provided initial funding of Euro 50 million. The cash window will be available from 2018 for the containment of diseases that may not be eligible for funding under the insurance window…

The bonds will be issued under IBRD’s “capital at risk” program because investors bear the risk of losing part or all of their investment in the bond if an epidemic event triggers pay-outs to eligible countries covered under the PEF.

The PEF covers six viruses that are most likely to cause a pandemic. These include new Orthomyxoviruses (new influenza pandemic virus A), Coronaviridae (SARS, MERS), Filoviridae (Ebola, Marburg) and other zoonotic diseases (Crimean Congo, Rift Valley, Lassa fever).
 
PEF financing to eligible countries will be triggered when an outbreak reaches predetermined levels of contagion, including number of deaths; the speed of the spread of the disease; and whether the disease crosses international borders. The determinations for the trigger are made based on publicly available data as reported by the World Health Organization (WHO).
Countries eligible for financing under the PEF’s insurance window are members of the International Development Association (IDA), the institution of the World Bank Group that provides concessional finance for the world’s poorest countries. The PEF will be governed by a Steering Body, whose voting members include Japan and Germany. WHO and the World Bank serve as non-voting members…

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Featured Journal Content
 
Pediatrics
July 2017, VOLUME 140 / ISSUE 1
http://pediatrics.aappublications.org/content/139/6?current-issue=y
Articles
Childhood Illness and the Gender Gap in Adolescent Education in Low- and Middle-Income Countries
Marcella Alsan, Anlu Xing, Paul Wise, Gary L. Darmstadt, Eran Bendavid
Pediatrics Jul 2017, 140 (1) e20163175; DOI: 10.1542/peds.2016-3175
Abstract
BACKGROUND: Achieving gender equality in education is an important development goal. We tested the hypothesis that the gender gap in adolescent education is accentuated by illnesses among young children in the household.
METHODS: Using Demographic and Health Surveys on 41,821 households in 38 low- and middle-income countries, we used linear regression to estimate the difference in the probability adolescent girls and boys were in school, and how this gap responded to illness episodes among children <5 years old. To test the hypothesis that investments in child health are related to the gender gap in education, we assessed the relationship between the gender gap and national immunization coverage.
RESULTS: In our sample of 120,708 adolescent boys and girls residing in 38 countries, girls were 5.08% less likely to attend school than boys in the absence of a recent illness among young children within the same household (95% confidence interval [CI], 5.50%–4.65%). This gap increased to 7.77% (95% CI, 8.24%–7.30%) and 8.53% (95% CI, 9.32%–7.74%) if the household reported 1 and 2 or more illness episodes, respectively. The gender gap in schooling in response to illness was larger in households with a working mother. Increases in child vaccination rates were associated with a closing of the gender gap in schooling (correlation coefficient=0.34, P=.02).
CONCLUSIONS: Illnesses among children strongly predict a widening of the gender gap in education. Investments in early childhood health may have important effects on schooling attainment for adolescent girls.

Excerpt
…In our analysis of vaccination rates relative to the education gap, we found a statistically significant and strong negative correlation between the vaccination rates of children <5 years old and the gender gap in education (eg, the higher the vaccination rate, the smaller the gender gap in education; correlation coefficient=0.34, P=.02; Fig 4). The adolescent gender gap in education approaches zero with coverage rates exceeding ∼70% for all 8 vaccines. We performed several specification checks to ensure that our results are robust. These include varying the age of the included older children, using alternative educational outcomes, and splitting the sample by rural and urban location. We describe these supplementary changes in detail. In Supplemental Fig 5, we varied the age thresholds for older children in the following different ways: 10 to 16, 10 to 17, 10 to 18, 11 to 16, 12 to 16, 12 to 17, and 12 to 18. Our results are not sensitive to varying the thresholds….
 
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Emergencies

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 29 June 2017 [GPEI]
:: In Syria, 15 new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in the past week, bringing the total number of cVDPV2 cases in the country to 17.  Sixteen of the 17 cases are from Mayadeen district, Deir-Al-Zour governorate, and one case is from Raqua district, Raqua governorate.  All cases had onset of paralysis between 3 March and 23 May.

:: The 14th report of the Independent Monitoring Board (IMB) has been published, following the group’s meeting in May.[see below]

:: Summary of newly-reported viruses this week:  Syria – 15 new circulating vaccine-derived poliovirus type 2 (cVDPV2) were isolated from acute flaccid paralysis (AFP) cases, and four new cVDPV2 isolated from healthy community contacts.  Pakistan – one new wild poliovirus type 1 (WPV1) isolated from an environmental sample

Weekly country updates as of 21 June 2017
:: Syrian Arab Republic
In Syria, 15 new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in the past week, bringing the total number of cVDPV2 cases to 17.  Sixteen of the 17 cases are from Mayadeen district, Deir-Al-Zour governorate, and one case is from Raqua district, Raqua governorate.  All cases had onset of paralysis between 3 March and 23 May.  Additionally, four cVDPV2s were also isolated from healthy community contacts, all from Mayadeen (collected in April and May).
Of a total of 65 acute flaccid paralysis (AFP) cases detected in Deir-Al-Zour since the start of 2017, 16 have now tested positive for cVDPV2 (with the 17th case from Raqua), 22 have tested negative, 5 are pending for final laboratory results and 22 specimens are en route to a laboratory for processing.
Confirmation of these latest cases is not unexpected at this time and does not change the operational situation, as outbreak response plans are being finalized, in line with internationally-agreed outbreak response protocols.  Although access to Deir-Al-Zour is compromised due to insecurity, the Governorate has been partially reached by several vaccination campaigns against polio and other vaccine-preventable diseases since the beginning of 2016. Most recently, two campaigns have been conducted in March and April 2017 using the bivalent oral polio vaccine (OPV). However, only limited coverage was possible through these campaigns.
 
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WHO Grade 3 Emergencies  [to 1 July 2017]
The Syrian Arab Republic 
:: Making the golden hours count: WHO trains Syrian health staff to treat chemical exposure and severe trauma  24 June 2017

Yemen
:: Yemen: cholera outbreak suspected cases exceeds 200 000
NEW YORK/GENEVA, 24 June 2017 – Joint news release UNICEF/WHO: The rapidly spreading cholera outbreak in Yemen has exceeded 200 000 suspected cases, increasing at an average of 5000 a day. We are now facing the worst cholera outbreak in the world.

Iraq  – No new announcements identified.
NigeriaNo new announcements identified.
South SudanNo new announcements identified.
 
 
WHO Grade 2 Emergencies  [to 1 July 2017]
Cameroon  No new announcements identified
Central African Republic  – No new announcements identified. 
Democratic Republic of the Congo  – No new announcements identified. 
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified
 
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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Iraq: Mosul Humanitarian Response Situation Report No. 38 (12 to 28 June 2017)

Syrian Arab Republic
:: Syria Crisis: Ar-Raqqa Situation Report No. 10 (19-26 June 2017)

YemenNo new announcements identified

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
Ethiopia
:: Ethiopia Weekly Humanitarian Bulletin, 27 June 2017

DRC (Kasai crisis)No new announcements identified.
NigeriaNo new announcements identified.
SomaliaNo new announcements identified.

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UNICEF  [to 1 July 2017]
https://www.unicef.org/media/media_94367.html
29 June 2017
UNICEF calls for the protection of children trapped in west Mosul’s violence
BAGHDAD, 29 June 2017 – “Thousands of children continue to be trapped in relentless violence in West Mosul’s Old City neighborhoods as the fighting heavily intensified over the past hours.

Children continue to bear the brunt of multiple emergencies in Sudan
KHARTOUM, Sudan, 28 June 2017 – Over the last few months, Sudan has faced multiple emergencies with the rapid spread of suspected cases of acute watery diarrhea across 12 of its 18 states, a significant influx of South Sudanese refugees, and high rates of malnutrition, especially in the Jebel Marra Area of Central Darfur.
 
UNICEF airlifts lifesaving supplies to Yemen to combat cholera as cases surpass 200,000
SANA’A, 28 June 2017 –Three UNICEF charter planes have delivered 36 tons of lifesaving medical and water purification supplies to Yemen to scale up efforts to combat the world’s worst cholera outbreak.
The supplies included, 750,000 sachets of Oral Rehydration Salt (ORS) enough to treat 10,000 people, 10.5 million water purification tablets and other sanitation items.
“We are in a race against time. Our teams are working with partners not only to provide treatment to the sick and raise awareness among communities, but also to rapidly replenish and distribute supplies and medicines ”, said Dr Sherin Varkey, UNICEF Deputy Representative in Yemen. “More airlifts of critical supplies will continue in the coming days”.
In just two months, cholera has spread to almost every governorate of Yemen. Already more than 1,300 people have died – one quarter of them children. Civil servants, including doctors, nurses, water engineers and rubbish collectors have not been paid for nearly 10 months.
Since the outbreak was reported on 27 April, UNICEF has distributed over 600,000 ORS sachets and 20,000 Intravenous (IV) fluids to oral rehydration points and at homes. With partners, UNICEF has supported the establishment of 488 oral rehydration therapy points and more than 20 Diarrhoea Treatment Centres across the country.

Statement from UNICEF Executive Director Anthony Lake and WHO Director-General Margaret Chan on the cholera outbreak in Yemen as suspected cases exceed 200,000
NEW YORK/GENEVA, 24 June 2017 – “The rapidly spreading cholera outbreak in Yemen has exceeded 200,000 suspected cases, increasing at an average of 5,000 a day. We are now facing the worst cholera outbreak in the world.
“In just two months, cholera has spread to almost every governorate of this war-torn country.  Already more than 1,300 people have died – one quarter of them children – and the death toll is expected to rise.
“UNICEF, WHO and our partners are racing to stop the acceleration of this deadly outbreak. We are working around the clock to detect and track the spread of disease and to reach people with clean water, adequate sanitation and medical treatment. Rapid response teams are going house-to-house to reach families with information about how to protect themselves by cleaning and storing drinking water.
“UNICEF and WHO are taking all measures to scale up prevention and treatment interventions.  We call on authorities in Yemen to strengthen their internal efforts to stop the outbreak from spreading further.
“This deadly cholera outbreak is the direct consequence of two years of heavy conflict. Collapsing health, water and sanitation systems have cut off 14.5 million people from regular access to clean water and sanitation, increasing the ability of the disease to spread.  Rising rates of malnutrition have weakened children’s health and made them more vulnerable to disease. An estimated 30,000 dedicated local health workers who play the largest role in ending this outbreak have not been paid their salaries for nearly 10 months.
“We urge all authorities inside the country to pay these salaries and, above all, we call on all parties to end this devastating conflict.”

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Editor’s Note:
We repeat here the Associated Press report from last week on OCV for Yemen. We have not identified any formal announcement of this action on the WHO website or otherwise about this important intervention.
War-Torn Yemen to Get Cholera Vaccines as Death Toll Mounts
New York Times/ASSOCIATED PRESS
JUNE 21, 2017
GENEVA — The U.N. health agency and some major partners have agreed to send 1 million doses of cholera vaccine to Yemen to help stanch a spiraling and increasingly deadly caseload in the impoverished country, which is already facing war and the risk of famine.
A spokesman for the World Health Organization said Wednesday that it didn’t initially want to publicize last week’s decision because questions remain about when and how the doses could reach the neediest people in a country sliced up along front lines and grappling with a nearly-collapsed health system.
WHO said the 1 million doses for Yemen were approved on June 15 by the International Coordinating Group…

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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 1 July 2017]
http://www.who.int/ebola/en/
WHO AFRO – External Situation Report 28: 30 June 2017
…Since our last update on 27 June, no new confirmed, probable or suspected cases have been reported. Two alerts were reported between 27 June and 28 June. One alert was from Mobenge and the other, a community death in Tobongisa, was considered a suspected case. All the alerts and the suspected cases were subsequently discarded following further investigation…

MERS-CoV [to 1 July 2017]
http://www.who.int/emergencies/mers-cov/en/
DONs- Disease Outbreak News
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia   28 June 2017
 
Zika virus  [to 1 July 2017]
http://www.who.int/emergencies/zika-virus/en/
[No new digest content identified]

Yellow Fever  [to 1 July 2017]
http://www.who.int/emergencies/yellow-fever/en/
23 June 2017
WHO issues updated positon paper on yellow fever vaccine
In a revised yellow fever (YF) vaccine position paper published in today’s edition of the Weekly Epidemiological Record, WHO provided updated guidance on the use of fractional dose YF vaccination in the context of YF vaccine supply shortages.
Weekly Epidemiological Record, 23 June 2017, vol. 92, 25 (pp. 345–356)
Yellow fever vaccine: WHO position on the use of fractional doses – June 2017
Global polio eradication: progress towards containment of poliovirus type 2, worldwide 2017
 
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WHO & Regional Offices [to 1 July 2017]

WHO & Regional Offices [to 1 July 2017]

Ending discrimination in health care settings
27 June 2017 – Discrimination in health care is widespread across the world and takes many forms. It violates the most fundamental human rights and affects both users of health care services and health care workers. The new joint United Nations statement on ending discrimination in health care settings calls for health workers to fulfil their responsibilities, but also to have their rights protected. Many health workers, especially women, are themselves vulnerable and victims of discrimination, abuse, and violence.
Read the joint UN statement

Public health surveillance ethics
26 June 2017 — Public health officials regularly collect and analyse data to map disease, spot patterns, identify causes and respond to outbreaks. But surveillance can lead to harm if people’s privacy is violated, or they are stigmatized on the basis of the information they provide about themselves. WHO’s new Guidelines on ethical issues in public health surveillance offer 17 guidelines that can assist everyone involved in surveillance to make the right decisions.

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Disease outbreak news
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia   28 June 2017
:: Human infection with avian influenza A(H7N9) virus – China   28 June 2017
:: Lassa Fever – Nigeria   28 June 2017

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Weekly Epidemiological Record, 30 June 2017, vol. 92, 26 (pp. 357–368)
Index of countries/areas; Index, Volume 92, 2017, Nos. 1–26
:: WHO Alliance for the Global Elimination of Trachoma by 2020: progress report on elimination of trachoma, 2014–2016

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: “Call-to-Action” – Putting People First: The Road to Universal Health Coverage in Africa – 28 June 2017
Brazzaville, 28 June 2017 – The World Health Organization’s inaugural Africa Health Forum ‘has concluded with a resounding call to action that all stakeholders in Africa must work together to achieve Universal Health Coverage (UHC), a key aim of the Sustainable Development Goals (SDGs).  Experts from a wide range of backgrounds including academics, ministers of health, intergovernmental agencies, academics, civil society, philanthropic foundations, private sector, and youth organisations attended the two-day landmark event organized by WHO under the theme: ‘Putting people first: The Road to Universal Health Coverage in Africa.’
:: Africa needs to act now to safeguard the health of its youth – 27 June 2017

WHO Region of the Americas PAHO
No new digest content identified.

WHO South-East Asia Region SEARO
No new digest content identified.
 
WHO European Region EURO
:: Countries mark World No Tobacco Day with outreach to all levels of society and across sectors 30-06-2017
:: Exploring synergies between health, climate change mitigation and nature conservation 28-06-2017
:: Europe’s small countries commit to ending childhood obesity 27-06-2017
:: New WHO report provides blueprint for delivering people-centred care for tuberculosis 26-06-2017

WHO Eastern Mediterranean Region EMRO
:: Partnerships, empowerment and action: a multisectoral response to end gender-based violence against women and girls in Asia and the Pacific  28 June 2017
:: Joint United Nations statement on ending discrimination in health care settings 27 June 2017
:: Statement from UNICEF Executive Director Anthony Lake and WHO Director-General Margaret Chan on the cholera outbreak in Yemen as suspected cases exceed 200,000 24 June 2017

WHO Western Pacific Region
:: Let’s talk about it: improving immunization coverage in Solomon Islands
29 June 2017 – Baby Joy looks around the room with bright, curious eyes, closely watching the nurse as she pulls on her white latex gloves. Joy is 17 weeks old, and that means she is overdue to receive four different vaccinations, as per Solomon Islands’ routine immunization schedule. Unfortunately, many children are like Joy: they receive their vaccinations late. In fact, over 25% do not receive the full schedule at all.
 
 
 

CDC/ACIP [to 1 July 2017]

CDC/ACIP [to 1 July 2017]
http://www.cdc.gov/media/index.html
Press Release
Wednesday, June 28, 2017
40th Annual Report on the Health of the Nation Features Long-Term Trends in Health and Health Care Delivery in the United States
CDC today released Health, United States, 2016,…

Press Release
Monday, June 26, 2017
Life at Ground Zero: The Story of the West African Ebola Outbreak
What was it like at ground zero of the worst outbreak of Ebola in history? This month, CDC’s David J. Sencer…

MMWR – June 29, 2017
:: Influenza Update
The 2016-17 flu season was relatively long and moderate in severity. Flu vaccination can vary in how well it works, but remains the best way to prevent influenza illness and associated complications. However, treatment with influenza antiviral medications close to the onset of illness is recommended for patients with confirmed or suspected influenza who have severe, complicated, or progressive illness; who require hospitalization; or who are at high risk for influenza complications. Although summer influenza activity in the United States typically is low, influenza cases and outbreaks do happen in summer months and clinicians should be vigilant in considering influenza when patients have summer respiratory illnesses. Influenza activity in the United States during 2016-17 was low through November, increased during December and peaked in February although there were regional differences in timing. Influenza A(H3N2) viruses were most common through mid-March and were predominate for the season overall, but influenza B viruses were most common from late March through May. Severity indicators (hospitalization and mortality rates) were within the range of what has been observed during previous seasons when influenza A(H3N2) viruses predominated. Final vaccine effectiveness estimates against flu-related outpatient medical visits was 42 percent (95% CI 35%–48%).

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Announcements

Announcements
 
Wellcome Trust  [to 1 July 2017]
https://wellcome.ac.uk/news
News / Published: 29 June 2017
Zika vaccine research: guidance for including pregnant women
New guidance for including pregnant woman and their babies in Zika vaccine research has been published today. It has been issued by a group of international experts in vaccinology, maternal and child health, public health and ethics.
Zika infection in pregnancy can have devastating effects on normal fetal development. But pregnant women are often automatically excluded from vaccine trials over safety concerns.
The guidelines argue that those most at risk from the virus – pregnant women and their babies – should be at the centre of Zika vaccine development.
What the guidance recommends
The guidance, developed with Wellcome funding, sets out how the research community can ensure that any vaccines developed are made available to those most at risk.
It puts forward three principles, each with recommendations directed at policymakers, funders, researchers, oversight bodies, regulatory authorities and the global public health community.
[1] To pursue and prioritise development of  Zika vaccines that can be used by pregnant women.
[2] To ensure data is collected in time to inform judgments about safety and efficacy of vaccine administration in pregnancy.
[3] To ensure pregnant women have fair access to participate in research studies…
 
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FDA [to 1 July 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
June 29, 2017 –
FDA unveils plan to eliminate orphan designation backlog
Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.
As authorized under the Orphan Drug Act, the Orphan Drug Designation Program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases, which are generally defined as diseases that affect fewer than 200,000 people in the United States. Orphan designation qualifies the sponsor of the drug for various development incentives, including tax credits for clinical trial costs, relief from prescription drug user fee if the indication is for a rare disease or condition, and eligibility for seven years of marketing exclusivity upon approval. A request for orphan designation is one step that can be taken in the drug development process and is different than the filing of a marketing application with the FDA.
Currently, the FDA has about 200 orphan drug designation requests that are pending review. The number of orphan drug designation requests has steadily increased over the past five years…
 
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IVI   [to 1 July 2017]
http://www.ivi.int/
June 30, 2017, Seoul, Korea
Changes in IVI’s Board of Trustees
The International Vaccine Institute (IVI) today announced several changes in its Board of Trustees (BOT). Three new members will join the Board: Mr. Malcolm Sweeney, Dr. Chris Varma, and Dr. Ros-Mari Bålöw. Each will serve a three-year term, which will take effect on November 16, 2017.
“The new Board members bring diversity and a wealth of experience in areas ranging from global finance to entrepreneurship to international development and cooperation research,” said Dr. Jerome Kim, IVI Director General. “They bring leadership experience from their respective fields, and I am pleased they are joining our board.”
   … Dr. Viveka Persso, who is from the Swedish National Agency for Higher Education was the Swedish representative on the Board since 2012 and also served as Vice Chair of the Board. George Bickerstaff was appointed as Board Vice Chair effectively immediately following Dr. Persson’s departure….
 
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Gavi [to 1 July 2017]
http://www.gavi.org/library/news/press-releases/
29 June 2017
Gavi welcomes US$ 1.5 million contribution from China Merchants Group
The pledge will support Gavi’s mission to immunise 300 million of the world’s poorest children by 2020.
Beijing, 29 June 2017 – China Merchants Charitable Foundation (CMCF), a charity affiliation of China Merchants Group (CMG) will contribute US$ 1.5 million to Gavi, the Vaccine Alliance, to support childhood immunisation in developing countries in 2017-2019. This multi-year pledge from CMG is the first agreement of its kind signed between Gavi and a private sector company in the Asia Pacific region.
“China Merchants Group has a deserved reputation as a global leader in logistics, supply chain and financial services, and this multi-year pledge underlines the company’s unwavering commitment to making a real difference to the lives of children in developing countries,” said Dr Seth Berkley, CEO of Gavi…
 
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GHIT Fund   [to 1 July 2017]
https://www.ghitfund.org/
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical ·
2017.06.28      
Event Report: GHIT Fund Replenishment Press Conference

The GHIT Fund held a press conference at the Kioi conference center in Tokyo on June 1, 2017, announcing its replenishment with a USD 200 million commitment for the next five years (FY2018-FY2022) from its funding partners. The following GHIT Council members participated: Government of Japan (Ministry of Foreign Affairs and Ministry of Health, Labour, and Welfare), Japanese pharmaceutical companies (Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Ltd., Eisai Co., Ltd., Shionogi & Co., Ltd., and Takeda Pharmaceutical Company, Ltd.), and Foundations (Bill & Melinda Gates Foundation and Welcome Trust)….
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NIH  [to 1 July 2017]
http://www.nih.gov/news-events/news-releases
June 28, 2017
NIH study sheds light on immune responses driving obesity-induced liver disease
Findings in mouse models reveal inflammatory factors that promote liver scarring.
June 27, 2017
Researchers develop microneedle patch for flu vaccination
The patch could be an alternative to needle-and-syringe immunization.
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UNAIDS  [to 1 July 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Press Release
UNAIDS Board seizes opportunities of change to deliver results
Board members unanimously approve US$ 484 million budget for 2018–2019.
GENEVA, 30 June 2017—UNAIDS’ 40th Programme Coordinating Board meeting has concluded in Geneva, Switzerland. Important decisions were taken on redefining the ways in which the Joint Programme works to deliver results efficiently and effectively and continues to advance global efforts to end the AIDS epidemic as part of the Sustainable Development Goals.
The Board affirmed the UNAIDS Joint Programme Action Plan as a way to progressively move towards a refined operating model. The Action Plan strengthens the coherence and effectiveness of UNAIDS’ support to countries and presents clear results and deliverables on joint working, financing, accountability and governance. The Board members also welcomed the final report of the Global Review Panel on the Future of the UNAIDS Joint Programme Model…
Press Release
Germany to double contributions to UNAIDS
The Government of Germany has announced that it will double its funding to UNAIDS in 2017-2018, to €5 million per year. Germany made the announcement at PCB-40.
 
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PhRMA    [to 1 July 2017]
http://www.phrma.org/press-room
June 27, 2017
More Than 50 Medicines and Vaccines in Development for HIV Infection, Treatment and Prevention
America’s biopharmaceutical companies are continuing the fight to conquer the human immunodeficiency virus (HIV), which can develop into acquired immune deficiency syndrome (AIDS), with 52 medicines and vaccines currently in development to help treat and prevent the infection, according to a report released today by PhRMA in partnership with The AIDS Institute.
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Sabin Vaccine Institute  [to 1 July 2017]
http://www.sabin.org/updates/pressreleases
Thursday, June 29, 2017
Thank You for Supporting END7! Changes are coming…

It’s been five years since the Sabin Vaccine Institute launched the END7 campaign to end neglected tropical diseases (NTDs). With your support, we mobilized funding to support programs that treated more than 50 million people, helped increase US and UK funding for NTDs and spread awareness of the global NTD burden.

As of June 1, 2017 we are no longer accepting donations for NTD treatment programs but we are working to ensure END7 advocacy efforts continue uninterrupted. We have concluded END7 fundraising activities and are working with a partner organization to continue advocacy for NTD treatment. END7 student advocacy efforts will continue this fall under the direction of another NTD organization, we will share more details about this exciting transition soon.

The Sabin Vaccine Institute, home of the END7 campaign, is dedicated to making vaccines more accessible, enabling innovation and expanding immunization across the globe. We intend to focus our energy going forward on expanding immunization…
 
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MSF/Médecins Sans Frontières  [to 1 July 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Proposed Executive Order Puts Pharma Interests Over People’s Lives
June 27, 2017
A leaked draft of President Trump’s executive order on drug pricing reveals that the White House will perpetuate policies that have led to a broken biomedical research and development (R&D) system and raise drug prices around the world, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).
Press release
Doctors Without Borders Urges India’s Modi to Remain Committed to Affordable Medicines During White House Meeting
June 26, 2017
As U.S. President Donald Trump and Indian Prime Minister Narendra Modi meet at the White House today, Doctors Without Borders/Médecins Sans Frontières (MSF) warned that U.S. pressure on India to change its drug regulatory and patent system could result in millions of people in the U.S. and around the world losing their lifeline of affordable medicines. As an international medical humanitarian organization that relies on affordable generic medicines produced in India to run its medical programs in more than 60 countries, MSF urged Modi to stand strong and protect India’s role as the “pharmacy of the developing world.”
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DCVMN – Developing Country Vaccine Manufacturers Network  [to 1 July 2017]
http://www.dcvmn.org/
[undated]
DCVMN Annual General Meeting
25 September 2017 to 28 September 2017
Seoul / Korea
 
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European Vaccine Initiative  [to 1 July 2017]
http://www.euvaccine.eu/news-events
27 June 2017
EDUFLUVAC workshop
“Four years of European research on the development of universal influenza vaccines: what have we learnt, and how can we move forward?”

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EDCTP    [to 1 July 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
28 June 2017
Botswana launch of AMBITION-cm project on HIV-associated cryptococcal meningitis
Almost twenty per cent of HIV-related deaths are directly attributable to cryptococcal meningitis (CM). The AMBITION-cm project was developed to
 
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Industry Watch
:: Takeda and Biological E. Limited Announce Partnership to Develop Low-Cost Combination Vaccines for Low- and Middle-Income Countries around the Globe
Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multi-national company Biological E. Limited (“BE”) to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP) and measles-rubella (MR) vaccines
OSAKA, Japan & HYDERABAD, India–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) and Biological E. Limited (“BE”) today announced that they have entered into a collaboration whereby two licensing agreements to expedite the development and delivery of affordable combination vaccines have been executed. BE will commercialize the vaccine in India, China and low- and middle-income countries where large, unmet public health needs exist.
Takeda has sold both the measles and pertussis vaccines in the Japanese market for more than 20 years. In heavily populated countries like India, where 25.7 million births occurred in 2015, substantial opportunities remain to deliver critical vaccines to those who need them. In the absence of access to vaccines in many parts of the world, this partnership illustrates Takeda’s desire to forge the kind of collaborations needed to overcome this public health challenge in low- and middle-income countries.
“Access to medicines is one of Takeda’s core values, and these agreements align with Takeda’s strategic goals to make high-impact contributions to global public health, either alone or through partners,” said Rahul Singhvi, Chief Operating Officer, Takeda Vaccine Business Unit. “These two agreements along with our current vaccine pipeline underscore our global commitment to address important infectious diseases across the globe.”

Under these agreements, Takeda will conduct a transfer from Japan to BE its existing measles and acellular pertussis vaccine bulk production technology, including the provision of technical services such as support in infrastructure review, training for production and quality control, technical assistance in process development, preclinical study design and production of clinical batch and the first commercial batches…
 
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Journal Watch

Journal Watch

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

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

Cost-effectiveness analysis of malaria interventions using disability adjusted life years: a systematic review

BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 1 July 2017)

Review
Cost-effectiveness analysis of malaria interventions using disability adjusted life years: a systematic review
Malaria continues to be a public health problem despite past and on-going control efforts. For sustenance of control efforts to achieve the malaria elimination goal, it is important that the most cost-effectiv…
Resign Gunda and Moses John Chimbari
Cost Effectiveness and Resource Allocation 2017 15:10
Published on: 1 July 2017

Ethics review of studies during public health emergencies – the experience of the WHO ethics review committee during the Ebola virus disease epidemic

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 1 July 2017)

Debate
Ethics review of studies during public health emergencies – the experience of the WHO ethics review committee during the Ebola virus disease epidemic
Emilie Alirol, Annette C. Kuesel, Maria Magdalena Guraiib, Vânia dela Fuente-Núñez, Abha Saxena and Melba F. Gomes
Published on: 26 June 2017
Abstract
Background
Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies.
WHO-ERC reviews
WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented.
Conclusions
To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, (6) direct information exchange between the chairs of advisory, safety review and ethics committees, (7) more Ethics Committee support for investigators than is standard and (8) a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care.

BMC Public Health (Accessed 1 July 2017)

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 1 July 2017)

Research article
Prevalence of high, medium and low-risk medical conditions for pneumococcal vaccination in Catalonian middle-aged and older adults: a population-based study
Updated population-based data on the frequency and distribution of risk factors for pneumococcal disease is scarce. This study investigated the prevalence of distinct comorbidities and underlying risk conditio…
Ochoa-Gondar, I. Hospital, A. Vila-Corcoles, M. Aragon, M. Jariod, C. de Diego and E. Satue

BMC Public Health 2017 17:610
Published on: 29 June 2017

Research article
Implementation of a human papillomavirus vaccination demonstration project in Malawi: successes and challenges
Cervical cancer is a major public health problem in Malawi. The age-standardized incidence and mortality rates are estimated to be 75.9 and 49.8 per 100,000 population, respectively. The availability of the hu…
Kelias Phiri Msyamboza, Beatrice Matanje Mwagomba, Moussa Valle, Hastings Chiumia and Twambilire Phiri
BMC Public Health 2017 17:599
Published on: 26 June 2017

Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials

Contemporary Clinical Trials
Volume 58, Pages 1-94 (July 2017)
http://www.sciencedirect.com/science/journal/15517144/58

Study Design, Statistical Design, Study Protocols
Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials
Original Research Article
Pages 13-22
Hui Quan, Xuezhou Mao, Yoko Tanaka, Bruce Binkowitz, Gang Li, Josh Chen, Ji Zhang, Peng-Liang Zhao, Soo Peter Ouyang, Mark Chang
Abstract
Extensive research has been conducted in the Multi-Regional Clinical Trial (MRCT) area. To effectively apply an appropriate approach to a MRCT, we need to synthesize and understand the features of different approaches. In this paper, examples are used to illustrate considerations regarding design, conduct, analysis and interpretation of result of MRCTs. We start with a brief discussion of region definitions and the scenarios where different regions have differing requirements for a MRCT. We then compare different designs and models as well as the corresponding interpretation of the results. We highlight the importance of paying special attention to trial monitoring and conduct to prevent potential issues associated with the final trial results. Besides evaluating the overall treatment effect for the entire MRCT, we also consider other key analyses including quantification of regional treatment effects within a MRCT, and assessment of consistency of these regional treatment effects.

Global Health: Science and Practice (GHSP) June 27, 2017, 5 (2)

Global Health: Science and Practice (GHSP)
June 27, 2017, 5 (2)
http://www.ghspjournal.org/content/current

EDITORIALS
Long-Acting HIV Treatment and Prevention: Closer to the Threshold
Substantial progress has been made toward viable, practical long-acting approaches to deliver HIV treatment and prevention through: (1) continued improvements in long-acting antiretrovirals (ARVs); (2) better innovative delivery systems; and (3) collaboration of willing partners to advance new ARVs. More progress on those 3 fronts is still needed to arrive at the goal of optimized HIV treatment and prevention for all who would benefit—and of finally controlling the HIV epidemic.
Matthew Barnhart
Glob Health Sci Pract 2017;5(2):182-187. http://dx.doi.org/10.9745/GHSP-D-17-00206

REVIEWS
Inequitable Access to Health Care by the Poor in Community-Based Health Insurance Programs: A Review of Studies From Low- and Middle-Income Countries
The poor lack equitable access to health care in community-based health insurance schemes. Flexible installment payment plans, subsidized premiums, and elimination of co-pays can increase enrollment and use of health services by the poor.
Chukwuemeka A Umeh, Frank G Feeley
Glob Health Sci Pract 2017;5(2):299-314.

In which developing countries are patents on essential medicines being filed?

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 1 July 2017]

Research
In which developing countries are patents on essential medicines being filed?
This article is based upon data gathered during a study conducted in partnership with the World Intellectual Property Organization on the patent status of products appearing on the World Health Organization’s …
Reed F Beall, Rosanne Blanchet and Amir Attaran
Globalization and Health 2017 13:38
Published on: 26 June 2017

Data Sharing Statements for Clinical Trials A Requirement of the International Committee of Medical Journal Editors

JAMA
June 27, 2017, Vol 317, No. 24, Pages 2463-2560
http://jama.jamanetwork.com/issue.aspx

Editorial
Data Sharing Statements for Clinical Trials A Requirement of the International Committee of Medical Journal Editors
Darren B. Taichman, MD, PhD; Peush Sahni, MB, BS, MS, PhD; Anja Pinborg, MD; et al.
The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups.1 Some applauded the proposal while others expressed disappointment it did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers…

Gravitating towards universal health coverage in the new WHO era

Lancet Global Health
Jul 2017 Volume 5 Number 7 e633-e726
http://www.thelancet.com/journals/langlo/issue/current

Editorial
Gravitating towards universal health coverage in the new WHO era
The Lancet Global Health
Open Access
DOI: http://dx.doi.org/10.1016/S2214-109X(17)30224-3

After a year of intense campaigning not devoid of controversies, WHO has a new leader. The election of Tedros Adhanom Ghebreyesus is the culmination of a series of firsts: he is the first Director-General elected via a more inclusive and transparent election process, the first African to be elected head of the agency, and the first non-physician to take the helm of the world’s foremost health institution. The excitement around this level of novelty is palpable: as Africa rejoices and congratulations converge from all sides of the global health political and technical communities, the overall sentiment wants to be one of hope—hope for the future of the embattled organisation at the hands of an experienced and successful technocrat and diplomat, and hope for renewed impetus to address the most pressing issues threatening the health of populations around the world.

The new WHO DG has laid out his priorities and first on the list is a familiar challenge: advancing universal health coverage (UHC). He has made clear that UHC is to be the “centre of gravity” of WHO’s work under his leadership. As such, he is picking up a process that—as laid out in Margaret Chan’s final report as WHO DG—started with the 1978 Health for All declaration of Alma-Ata and the push for primary health care, and through the ups and downs of an initially misunderstood and several times renewed concept, found a most vibrant expression in the 2010 “World Health Report on Health systems financing: the path to universal coverage”, which concentrated on demonstrating the financial feasibility of UHC. The concept crystallised as a development issue with the 2012 UN General Assembly resolution on UHC, and finally the inclusion of UHC in the 2030 Agenda for Sustainable Development, in SDG3, target 8. A place has been carved for UHC on the global agenda, and Tedros has committed to making it happen. We look forward to seeing how he will tackle this challenge.

And a challenge it will be. The economic case for UHC has been well discussed, the notions of equity and rights seem acquired, and studies are providing increased granularity to the monitoring of the health benefits of UHC. A recent article in The Lancet on an index of health care quality and access based on amenable mortality shows, among other things, how countries such as Tedros’ own Ethiopia, while still not performing well on this index, have been able to go beyond expectations between 1990 and 2015 in terms of access and quality. But clearly progress has been variable and there are gaps in coverage across and within countries. The new DG himself has acknowledged that while UHC has been the focus of the global health community for some time, progress has been slow. He has done so indirectly in our pages during his campaign, in his careful response to an open letter to the DG candidates on a patient-centred R&D agreement, where he recognised that one aspect of UHC—the delivery of quality health products for diseases affecting the most vulnerable population—remains poorly addressed, evoking market failures and lack of political will. Indeed, he has qualified the lack of political commitment, rather than lack of resources, as the biggest constraint for progress in UHC.

Obviously countries moving towards UHC face a number of choices, from policy negotiations and decisions to financing and implementation, that are inherently political. Conflicting priorities between ministries of finance and ministries of health can, and often do, clash. Ideological struggles and political interests also slow down or hamper progress. A case and point is that of the USA, where Barack Obama’s UHC-friendly Affordable Care Act is being hammered down by Donald Trump’s policy proposals.

Venturing into politically-charged terrain is tricky for WHO. The level of comfort is high on technical issues like financing and governance, but work on the political determinants and the political economy of UHC, while key for successful reforms, is not as conspicuous. Yet advocating for the outcome rather than the means to get to UHC, as Tedros has said should be WHO’s strategy, requires it. As Ethiopia’s former Minister of Foreign Affairs, he has undoubtedly gained key experience in high-level political engagement. Those sharp political skills will be invaluable in forging the new road ahead.

Innovative financing instruments for global health 2002–15: a systematic analysis

Lancet Global Health
Jul 2017 Volume 5 Number 7 e633-e726
http://www.thelancet.com/journals/langlo/issue/current

Health Policy
Innovative financing instruments for global health 2002–15: a systematic analysis
Prof Rifat Atun, FRCP, Sachin Silva, MSc, Prof Felicia M Knaul, PhD
Open Access
DOI: http://dx.doi.org/10.1016/S2214-109X(17)30198-5
Summary
Development assistance for health (DAH), the value of which peaked in 2013 and fell in 2015, is unlikely to rise substantially in the near future, increasing reliance on domestic and innovative financing sources to sustain health programmes in low-income and middle-income countries. We examined innovative financing instruments (IFIs)—financing schemes that generate and mobilise funds—to estimate the quantum of financing mobilised from 2002 to 2015. We identified ten IFIs, which mobilised US$8·9 billion (2·3% of overall DAH) in 2002–15. The funds generated by IFIs were channelled mostly through GAVI and the Global Fund, and used for programmes for new and underused vaccines, HIV/AIDS, malaria, tuberculosis, and maternal and child health. Vaccination programmes received the largest amount of funding ($2·6 billion), followed by HIV/AIDS ($1080·7 million) and malaria ($1028·9 million), with no discernible funding targeted to non-communicable diseases.

Lancet Infectious Diseases Jul 2017 Volume 17 Number 7 p673-780 e197-e234

Lancet Infectious Diseases
Jul 2017 Volume 17 Number 7 p673-780   e197-e234
http://www.thelancet.com/journals/laninf/issue/current

Editorial
Between the devil and the deep blue sea
The Lancet Infectious Diseases
Published: July 2017
DOI: http://dx.doi.org/10.1016/S1473-3099(17)30355-9

An unprecedented number of people escaping conflict and poverty have migrated from Asia and Africa towards Europe in recent years. A report from the UN High Commissioner for Refugees estimated that in 2016 alone around 362 376 people crossed the Mediterranean Sea, risking their lives to reach Europe. These new arrivals were in addition to more than 1 million refugees and migrants who had crossed the Mediterranean Sea on makeshift boats in 2015. Because of their geographical location, Greece and Italy have been the countries facing a continuous influx of migrants, mainly people aiming to move to northern European nations. However, with the closure of the borders to migrants in several countries along the Balkan route, including the Greece–Macedonia border, Greece has become the place where migrants are stranded in refugees camps.

At the end of 2016, the population residing in the 51 existing hosting facilities in Greece was estimated to be around 62 700 people. Most refugees reaching Greece have come from Syria, Afghanistan, and Iraq. The situation in the refugee camps varies but overcrowding and poor hygienic conditions prevail, creating a favourable milieu for the spread of infectious diseases. Thus, it is not surprising that, as described in a Newsdesk report in this issue, a high number of cases of hepatitis A were reported in Greek hosting facilities for refugees in 2016. In total, 177 laboratory-confirmed symptomatic cases were reported; of these, 149 (84%) occurred in hosting camps, mostly among Syrian children younger than 15 years. All cases reported symptom onset after their entry into the country. As a consequence, 599 vaccinations (of 309 contacts aged 1–14 years and 290 contacts aged 15 or older) were done during ring vaccination of the 177 reported cases.

Hepatitis A is primarily transmitted through the faecal-oral route, either by person-to-person contact or by consumption of contaminated food or water. Although the disease is mainly asymptomatic in children, its severity increases with age with some adults experiencing acute liver failure, especially in the presence of underlying conditions. A Review in this journal describes the epidemiology of hepatitis A virus infection across Europe during the past 40 years, which shows that susceptibility to the disease in adults is increasing in large parts of Europe because of low endemicity. The emergence of hepatitis A in refugee camps in Greece shows that it is likely that migrants have similar susceptibility to the indigenous population for hepatitis A and that the conditions in which they are detained are extremely poor. Although the outbreak of hepatitis A was contained with interventions that included improving hygienic conditions and ring vaccination of contacts, the effort was complicated by some of the common challenges when dealing with migrants’ health such as tracking population mobility, identification of contacts, and lack of information on vaccination history.

The difficulty of collecting information on the health status of migrants results in a lack of consensus on the best approach for screening and vaccination in this vulnerable population. Although migrants are eligible for universal care in both Greece and Italy, the reality is that access to the local health services remains difficult in these populations, so data on their main health issues are limited. A recent study of migrants in Italy reported that health problems in this population vary depending on the phase of their journey. At arrival in the host country the main issues reported by migrants are physical and psychological traumas, unwanted pregnancies, and scabies. Yet, once migrants settle in a camp, tuberculosis, vaccine preventable diseases such as hepatitis A, and sexually-transmitted infections become the major problem.

Currently, a series of projects supported by the European Union’s Health Programme are aiming at developing a shared system for collection and transmission of health data that should reduce the risk of overtreatment and repetition of diagnostic tests. Better information would also facilitate the implementation of vaccination campaigns to close the gaps caused by migration, which in turn would reduce the chances that outbreaks such as the one described for hepatitis A could occur again.

Efforts to improve screening of the health needs of migrants should reflect a more inclusive attitude of the European Union towards migrants in the future. Migrants have not escaped from tragedy in their countries to meet disease and neglect in refugees camps. They deserve better.

Articles
Estimating the future burden of multidrug-resistant and extensively drug-resistant tuberculosis in India, the Philippines, Russia, and South Africa: a mathematical modelling study
Aditya Sharma, Andrew Hill, Ekaterina Kurbatova, Martie van der Walt, Charlotte Kvasnovsky, Thelma E Tupasi, Janice C Caoili, Maria Tarcela Gler, Grigory V Volchenkov, Boris Y Kazennyy, Olga V Demikhova, Jaime Bayona, Carmen Contreras, Martin Yagui, Vaira Leimane, Sang Nae Cho, Hee Jin Kim, Kai Kliiman, Somsak Akksilp, Ruwen Jou, Julia Ershova, Tracy Dalton, Peter Cegielski for the Global Preserving Effective TB Treatment Study Investigators

Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial
Luis Rivera, Rasmus S Pedersen, Lourdes Peña, Klaus J Olsen, Lars V Andreasen, Ingrid Kromann, Pernille I Nielsen, Charlotte Sørensen, Jes Dietrich, Ananda S Bandyopadhyay, Birgit Thierry-Carstensen

Meningococcal serogroup B strain coverage of the multicomponent 4CMenB vaccine with corresponding regional distribution and clinical characteristics in England, Wales, and Northern Ireland, 2007–08 and 2014–15: a qualitative and quantitative assessment
Sydel R Parikh, Lynne Newbold, Stephanie Slater, Maria Stella, Monica Moschioni, Jay Lucidarme, Rosita De Paola, Maria Giuliani, Laura Serino, Stephen J Gray, Stephen A Clark, Jamie Findlow, Mariagrazia Pizza, Mary E Ramsay, Shamez N Ladhani, Ray Borrow

Childhood Illness and the Gender Gap in Adolescent Education in Low- and Middle-Income Countries

Pediatrics
July 2017, VOLUME 140 / ISSUE 1
http://pediatrics.aappublications.org/content/139/6?current-issue=y

Articles
Childhood Illness and the Gender Gap in Adolescent Education in Low- and Middle-Income Countries
Marcella Alsan, Anlu Xing, Paul Wise, Gary L. Darmstadt, Eran Bendavid
Pediatrics Jul 2017, 140 (1) e20163175; DOI: 10.1542/peds.2016-3175
Abstract
BACKGROUND: Achieving gender equality in education is an important development goal. We tested the hypothesis that the gender gap in adolescent education is accentuated by illnesses among young children in the household.
METHODS: Using Demographic and Health Surveys on 41,821 households in 38 low- and middle-income countries, we used linear regression to estimate the difference in the probability adolescent girls and boys were in school, and how this gap responded to illness episodes among children <5 years old. To test the hypothesis that investments in child health are related to the gender gap in education, we assessed the relationship between the gender gap and national immunization coverage.
RESULTS: In our sample of 120,708 adolescent boys and girls residing in 38 countries, girls were 5.08% less likely to attend school than boys in the absence of a recent illness among young children within the same household (95% confidence interval [CI], 5.50%–4.65%). This gap increased to 7.77% (95% CI, 8.24%–7.30%) and 8.53% (95% CI, 9.32%–7.74%) if the household reported 1 and 2 or more illness episodes, respectively. The gender gap in schooling in response to illness was larger in households with a working mother. Increases in child vaccination rates were associated with a closing of the gender gap in schooling (correlation coefficient=0.34, P=.02).
CONCLUSIONS: Illnesses among children strongly predict a widening of the gender gap in education. Investments in early childhood health may have important effects on schooling attainment for adolescent girls.

Excerpt
…In our analysis of vaccination rates relative to the education gap, we found a statistically significant and strong negative correlation between the vaccination rates of children <5 years old and the gender gap in education (eg, the higher the vaccination rate, the smaller the gender gap in education; correlation coefficient=0.34, P=.02; Fig 4). The adolescent gender gap in education approaches zero with coverage rates exceeding ∼70% for all 8 vaccines. We performed several specification checks to ensure that our results are robust. These include varying the age of the included older children, using alternative educational outcomes, and splitting the sample by rural and urban location. We describe these supplementary changes in detail. In Supplemental Fig 5, we varied the age thresholds for older children in the following different ways: 10 to 16, 10 to 17, 10 to 18, 11 to 16, 12 to 16, 12 to 17, and 12 to 18. Our results are not sensitive to varying the thresholds….

 

Vaccination to prevent human papillomavirus infections: From promise to practice

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 1 July 2017)
Essay

Vaccination to prevent human papillomavirus infections: From promise to practice
Paul Bloem, Ikechukwu Ogbuanu
| published 27 Jun 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002325
Summary points
:: A large proportion of the disease burden related to infection with human papillomavirus (HPV), the most common sexually transmitted infection, can be prevented through vaccination.
:: There is inequity in access to HPV vaccines, and populations with the largest burden of HPV-related diseases have the least access to the vaccines.
:: Affordability and sustainable financing of HPV vaccination are barriers to introduction in low- and middle-income countries because of the relatively high cost of the vaccine and its delivery to a nontraditional target population.

Venezuela and its rising vector-borne neglected diseases

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 1 July 2017)
Editorial

Venezuela and its rising vector-borne neglected diseases
Peter J. Hotez, María-Gloria Basáñez, Alvaro Acosta-Serrano, Maria Eugenia Grillet
Published: June 29, 2017
https://doi.org/10.1371/journal.pntd.0005423
[Initial text]
Poverty remains the overriding social determinant for the neglected tropical diseases (NTDs), but over the last several decades, we have also seen how political destabilization or even outright conflict can hasten economic declines and promote a substantial uptick in NTD incidence and prevalence [1]. Recent examples include the emergence of Ebola virus infection in West Africa [2], visceral leishmaniasis and other NTDs in East Africa [3, 4], and cutaneous leishmaniasis in the Middle East and North Africa [5], as well as guerilla activities linked to the drug trade in Latin America [6]. Vector-borne (taken here to encompass diseases transmitted by arthropods or snails) and zoonotic NTDs have been disproportionately represented among these emerging or reemerging infections.
A recent example of vector-borne NTDs reemerging due to political destabilization and economic collapse has been happening in Venezuela …

Value Choices in Summary Measures of Population Health

Public Health Ethics
Volume 10, Issue 2  July 2017
http://phe.oxfordjournals.org/content/current

Symposium on Daniel Hausman’s Valuing Health: Well-Being, Freedom and Suffering
Original Articles
Value Choices in Summary Measures of Population Health
Andrew Schroeder
Abstract
Summary measures of health, such as the quality-adjusted life year and disability-adjusted life year, have long been known to incorporate a number of value choices. In this paper, though, I show that the value choices in the construction of such measures extend far beyond what is generally recognized. In showing this, I hope both to improve the understanding of those measures by epidemiologists, health economists and policy-makers, and also to contribute to the general debate about the extent to which such measures should be adjusted to reflect ethical values.

Cholera vaccine faces major test in Yemen

Science         
30 June 2017  Vol 356, Issue 6345
http://www.sciencemag.org/current.dtl
In Depth  Global Health

Cholera vaccine faces major test in Yemen
Kai Kupferschmidt
Summary
On 15 June, a group managing the modest global reserve of cholera vaccine decided to dispatch 1 million doses to war-torn Yemen, which is suffering from a massive cholera outbreak. Cases began rising sharply in April and have already reached an estimated 200,000, causing 1300 deaths, most of them in the west of the country. There are now 5000 new cases every day, on both sides of the front lines. The vaccination campaign will be one of the biggest tests yet for the vaccine; the global stockpile was created only 4 years ago and has been used mostly for smaller campaigns. But where to deploy it within Yemen is still under debate.

Vaccine Volume 35, Issue 32, Pages 3905-4056 (13 July 2017)

Vaccine
Volume 35, Issue 32, Pages 3905-4056 (13 July 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/32

Commentaries
The $100,000 vaccine challenge: Another method of promoting anti-vaccination pseudoscience
Pages 3905-3906
Craig A. Foster

Vaccination resilience: Building and sustaining confidence in and demand for vaccination
Pages 3907-3909
Eve Dubé, Noni E. MacDonald

ADE and dengue vaccination
Pages 3910-3912
Ruth Aralí Martínez-Vega, Gabriel Carrasquila, Expedito Luna, José Ramos-Castañeda
Abstract
The vaccine against Dengue virus (DENV), Dengvaxia® (CYD), produced by Sanofi-Pasteur, has been registered by several national regulatory agencies; nevertheless, the performance and security of this vaccine have been challenged in a series of recent papers. In this work, we intend to contribute to the debate by analyzing the concept of an enhancing vaccine, presenting objections to the epidemiological model base of the concept and, likewise, presenting data that contradict that concept.

Universal measles-mumps-rubella vaccination to new recruits and the incidence of mumps in the military

Vaccine
Volume 35, Issue 32, Pages 3905-4056 (13 July 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/32

Short communication
Universal measles-mumps-rubella vaccination to new recruits and the incidence of mumps in the military
Pages 3913-3916
Jong Youn Moon, Jaehun Jung, Kyungmin Huh
Abstract
In response to the resurgence of mumps, the Korean Armed Forces started the measles-mumps-rubella (MMR) vaccination to all new recruits regardless of prior vaccination history. We evaluated the effectiveness of the vaccination by comparing the incidence between the military and civilian populations before and after implementation of the new policy. The standardized incidence ratio of mumps in the military was 7.06 in the prevaccine period, which declined to 0.96 in the postvaccine period. Vaccine effectiveness was estimated at 86.4%. Incidence rate ratio was lower in the 1996–1998 birth cohort (BC) compared with 1989–1995 BC (0.10 vs. 0.55), suggesting higher effectiveness of vaccination in the 1996–1998 BC. Our data provide evidence for the use of the MMR vaccination in the prevention of mumps in high-risk adults.

Guide to active vaccine safety surveillance: Report of CIOMS working group on vaccine safety – executive summary

Vaccine
Volume 35, Issue 32, Pages 3905-4056 (13 July 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/32

Regular Papers
Guide to active vaccine safety surveillance: Report of CIOMS working group on vaccine safety – executive summary
Original Research Article
Pages 3917-3921
Heininger, K. Holm, I. Caplanusi, S.R. Bailey, on behalf of the CIOMS Working Group on Vaccine Safety

Abstract
In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines targeting diseases specifically endemic to many resource-limited countries (RLCs), e.g. malaria, dengue.
The WG created a Guide to Active Vaccine Safety Surveillance (AVSS) to assist national regulatory authorities and national immunization program officers in RLCs in determining the best course of action with regards to non-routine pharmacovigilance activities, when confronted with a launch of a new vaccine or a vaccine that is new to their country.
Here we summarize the results of the WG, further detailed in the Guide, which for the first time provides a structured approach to identifying and analyzing specific vaccines safety knowledge gaps, while considering all available sources of information, in order to determine whether AVSS is an appropriate solution. If AVSS is confirmed as being the appropriate tool, the Guide provides additional essential information on AVSS, a detailed overview of common types of AVSS and practical implementation considerations. It also provides a framework for a well-constructed and informative AVSS when needed, thus aiming to ensure the best possible safety of immunization in this new landscape.

Impact and cost-effectiveness of rotavirus vaccination in Bangladesh

Vaccine
Volume 35, Issue 32, Pages 3905-4056 (13 July 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/32

Impact and cost-effectiveness of rotavirus vaccination in Bangladesh
Original Research Article
Pages 3982-3987
Clint Pecenka, Umesh Parashar, Jacqueline E. Tate, Jahangir A.M. Khan, Devin Groman, Stephen Chacko, Md Shamsuzzaman, Andrew Clark, Deborah Atherly
Abstract
Introduction
Diarrheal disease is a leading cause of child mortality globally, and rotavirus is responsible for more than a third of those deaths. Despite substantial decreases, the number of rotavirus deaths in children under five was 215,000 per year in 2013. Of these deaths, approximately 41% occurred in Asia and 3% of those in Bangladesh. While Bangladesh has yet to introduce rotavirus vaccination, the country applied for Gavi support and plans to introduce it in 2018. This analysis evaluates the impact and cost-effectiveness of rotavirus vaccination in Bangladesh and provides estimates of the costs of the vaccination program to help inform decision-makers and international partners.
Methods
This analysis used Pan American Health Organization’s TRIVAC model (version 2.0) to examine nationwide introduction of two-dose rotavirus vaccination in 2017, compared to no vaccination. Three mortality scenarios (low, high, and midpoint) were assessed. Benefits and costs were examined from the societal perspective over ten successive birth cohorts with a 3% discount rate. Model inputs were locally acquired and complemented by internationally validated estimates.
Results
Over ten years, rotavirus vaccination would prevent 4000 deaths, nearly 500,000 hospitalizations and 3 million outpatient visits in the base scenario. With a Gavi subsidy, cost/disability adjusted life year (DALY) ratios ranged from $58/DALY to $142/DALY averted. Without a Gavi subsidy and a vaccine price of $2.19 per dose, cost/DALY ratios ranged from $615/DALY to $1514/DALY averted.
Conclusion
The discounted cost per DALY averted was less than the GDP per capita for nearly all scenarios considered, indicating that a routine rotavirus vaccination program is highly likely to be cost-effective. Even in a low mortality setting with no Gavi subsidy, rotavirus vaccination would be cost-effective. These estimates exclude the herd immunity benefits of vaccination, so represent a conservative estimate of the cost-effectiveness of rotavirus vaccination in Bangladesh.
 

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

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

Contemporary Clinical Trials Communications
Volume 7,   In Progress   (September 2017)
Factors associated with willingness to participate in a vaccine clinical trial among elderly Hispanic patients
S Rikin, S Shea, P LaRussa, M Stockwell
Abstract
A population specific understanding of barriers and facilitators to participation in clinical trials could improve recruitment of elderly and minority populations. We investigated how prior exposure to clinical trials and incentives were associated with likelihood of participation in a vaccine clinical trial through a questionnaire administered to 200 elderly patients in an academic general internal medicine clinic. Wilcoxon signed rank sum test compared likelihood of participation with and without monetary incentives. Logistic regression evaluated characteristics associated with intent to participate in an influenza vaccine trial, adjusted for age, gender, language, and education history. When asked about likelihood of participation if there was monetary compensation, there was a 12.2% absolute increase in those reporting that they would not participate, with a significant difference in the distribution of likelihood before and after mentioning a monetary incentive (Wilcoxon signed rank test, p=0.001). Those with previous knowledge of clinical trials (54.4%) were more likely to report they would participate vs. those without prior knowledge (OR 2.5, 95% CI [1.2, 5.2]). The study highlights the importance of pre-testing recruitment materials and incentives in key group populations prior to implementing clinical trials.

Media/Policy Watch

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.
 
 
The Atlantic
http://www.theatlantic.com/magazine/
Accessed 1 July 2017
[No new, unique, relevant content]
A Clever New Way to Predict Next Year’s Flu
A study suggests an unusual strategy to make vaccines more effective.
Sarah Zhang
Jun 27, 2017
…In search of new ways to understand flu evolution, a group of scientists in Seattle decided to try something unusual. They didn’t bother to look at ordinary people sick with the flu. They instead decided to track how H3N2 viruses change in people with weakened immune systems, who come down with the flu for months at a time. Surprisingly, the mutations that arose in these patients ended up being some of the same ones that dominated global trends years later. Just four patients were microcosms for the greater world when it came to flu evolution…

How the World Can Prepare for the Next Pandemic
Global outbreaks like the 2014 episode of Ebola are a certainty in a connected world, which means public-health authorities have to think across borders too.
David A. Graham
Jun 30, 2017

Forbes
http://www.forbes.com/
Accessed 1 July 2017
John Oliver Brought Emotions To A Data Fight, And I Think He Won
30 June 2017
Kavin Senapathy, Contributor
The vaccine segment of Last Week Tonight is a lesson in persuasion.
 

Foreign Policy
http://foreignpolicy.com/
Accessed 1 July 2017
Laurie Garrett: Science Won’t Save Vaccines From Lawsuits Anymore
Europe’s highest court has just cleared the way for vaccine-truthers to sue manufacturers, even without any evidence.
26 June 2017

The Guardian
http://www.guardiannews.com/
Accessed 1 July 2017
John Oliver on vaccines: One of humanity’s most incredible accomplishments
26 June 2017
On Last Week Tonight, the host used his monologue to focus on the growing anti-vaccine feeling, ‘amplified by the human megaphone that is the president’.
John Oliver talked about vaccines on Sunday night, exploring their history, politicization and the growing number of skeptics.
“Vaccines are one of humanity’s most incredible accomplishments and they’ve saved millions of lives,” Oliver began. “There was a time when a new one was cause for huge celebration. It’s true – people lined up for the polio shot like it was an iPhone.
“But despite their success, small groups are both skeptical and vocal about vaccines, which is nothing new,” he continued. “But these days their voice has been amplified by the human megaphone that is the president of the United States.”…

New York Times
http://www.nytimes.com/
Accessed 1 July 2017
Stopping Pandemics Before They Start
Ebola was finally stopped by rushing a vaccine to Africa. Now a project is planning to be more ready for the next pandemic threat [CEPI].
June 27, 2017 – By TINA ROSENBERG – Opinion
 
U.N. Brought Cholera to Haiti. Now It Is Fumbling Effort to Atone.
By RICK GLADSTONE
JUNE 26, 2017
Even as the United Nations expresses growing alarm over a cholera outbreak in war-ravaged Yemen, the organization is increasingly worried about the fallout from a stubborn cholera scourge in Haiti that was caused by its own peacekeepers more than six years ago.

A $400 million voluntary trust fund for Haiti to battle cholera was created last year by Ban Ki-moon, then the secretary general, when he apologized for the United Nations’ role after having repeatedly denied any responsibility. But the fund, meant in part to compensate cholera victims, garnered only a few million dollars and is now nearly empty.
Entreaties by Mr. Ban’s successor, António Guterres, for charitable contributions have gone unanswered. Moreover, a proposal announced on June 14 by Mr. Guterres’s office to repurpose $40.5 million in leftover money from the soon-to-be disbanded peacekeeping mission in Haiti for use in the cholera fight has faced strong resistance from other countries…

Washington Post
http://www.washingtonpost.com/
We’re closer than ever to eradicating Polio — and yet there’s Syria
25 June 2017
By Editorial Board June 25
WONDERFUL AS it is to recall the glories of the manned space program — the exhilaration and sense of infinite possibilities for humanity — there were also setbacks, disasters and disappointments. Something similar is happening now with polio and the world’s longest and most ambitious quest to eradicate the poliovirus, which is highly contagious, largely strikes children under 5 years old and can cause permanent paralysis. Thanks to vaccination, the eradication effort is closer to success today than at any time in 30 years. Yet all of a sudden, a new outbreak has appeared in Syria. Is the goal about to be lost?

Not exactly, but the mixture of optimism and worry is warranted. As recently as the mid-1980s, polio paralyzed more than 350,000 children a year in 125 countries where it was endemic. As Microsoft founder and philanthropist Bill Gates pointed out recently, that’s 40 cases an hour. By contrast, so far this year, the last three endemic countries have reported a total of only six cases of wild poliovirus, fewer than at any moment ever: four in Afghanistan and two in Pakistan, and none so far this year in Nigeria. This is an extraordinary accomplishment by people, biomedicine and philanthropy. Just a few years ago, Pakistan, for example, appeared to be spinning out of control, with vaccination workers murdered while on the job, and whole sectors beyond reach of immunization. Globally, some 16 million people are walking today who might otherwise have been afflicted with paralysis from polio, Mr. Gates noted.

The numbers are so low today that eradication may indeed be within reach, if there is not another setback in the remaining endemic countries. For this, immunization and surveillance must be sustained. On June 12, philanthropists and governments once again backed the Global Polio Eradication Initiative, a public-private partnership aimed at the second-ever eradication of a disease, after smallpox. At the Rotary International convention in Atlanta, $1.2 billion was pledged. Up to $150 million raised in the next three years by Rotary International, which has been at the forefront of the battle since 1985, will be matched two-to-one by the Gates Foundation, which pledged a total of $450 million, including the match. The remaining will come from other donors, all to make sure there is no relapse and a final fight to the finish.

The one dark spot is Syria, where a fresh outbreak has paralyzed 17 children, most from Mayadin, south of Deir al-Zour, and one child from Raqqa, where the Islamic State is headquartered. This is the second polio outbreak of the war. It was caused by a weakened form of the virus from the polio vaccine itself, which in rare cases mutates and becomes virulent against the unvaccinated, spreading through contaminated sewage or water. The real culprit is the upheaval of war. Fortunately, there is an effective vaccine and a fair amount of experience in extinguishing such an outbreak, and with enough effort and immunization, it can be contained.

The moonshot may yet succeed.

Vaccines and Global Health: The Week in Review 24 June 2017

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

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

 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_24 June 2017

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

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

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

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

Milestones :: Perspectives

Milestones :: Perspectives

Editor’s Note
Some observers suggest we are already in a “post-truth era.”  We observe that the judgement by the Court of Justice of the European Union suggests it might better be termed the “post-evidence era.” I was reminded of an undergraduate logic course [from many decades ago before the post-truth era] and one of the first fallacies we engaged: “post hoc, ergo propter hoc” [after this, therefore because of this]. We will monitor and report on any balanced legal/policy analysis of this judgement and its implications for vaccine injury litigation.

Court of Justice of the European Union
PRESS RELEASE No 66/2017
Luxembourg, 21 June 2017 Judgment in Case C-621/15
>W and Others v Sanofi Pasteur MSD and Others

Where there is a lack of scientific consensus, the proof of the defect of the vaccine and of a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence
[Full text, Editor’s text bolding]
 
The temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered may, where applicable, constitute sufficient evidence to make out such proof

Between the end of 1998 and the middle of 1999 Mr J. W was vaccinated against hepatitis B using a vaccine produced by Sanofi Pasteur. In August 1999, Mr W began to present with various troubles, which led to a diagnosis of multiple sclerosis in November 2000. Mr W died in 2011. Earlier, in 2006, he and his family had brought legal proceedings against Sanofi Pasteur to obtain compensation for the damage they claim Mr W suffered due to the vaccine.

The case was sent before the cour d’appel de Paris (Court of Appeal, Paris, France), which observed, inter alia, that there was no scientific consensus supporting a causal relationship between the vaccination against hepatitis B and the occurrence of multiple sclerosis. It held that no such causal link had been demonstrated and dismissed the action.

The French Cour de cassation (Court of Cassation), before which an appeal against the judgment of the Cour d’appel de Paris was brought, asks the Court of Justice whether, despite there being no scientific consensus and given that, under the EU directive on liability for defective products, [1] the injured person is required to prove the damage, the defect and the causal relationship, the court may base itself on serious, specific and consistent evidence enabling it to conclude that there is a causal link between the defect in a vaccine and that there is a causal link between the vaccine and the disease. Reference has been made in particular to Mr W’s previous excellent state of health, the lack of family antecedents and the close temporal connection between the vaccination and the appearance of the disease.

In today’s judgment, the Court holds that evidentiary rules allowing the court, where there is not certain and irrefutable evidence, to conclude that there is a defect in a vaccine and a causal link between the defect and a disease on the basis of a set of evidence the seriousness, specificity and consistency of which allows it to consider, with a sufficiently high degree of probability, that such a conclusion corresponds to the reality of the situation, are compatible with the Directive.

Such evidentiary rules do not bring about a reversal of the burden of proof which it is for the victim to discharge, since that system places the burden on the victim to prove the various elements of his case which, taken together, will provide the court hearing the case with a basis for its conclusion as to the existence of a defect in the vaccine and a causal link between that defect and the damage suffered.

Moreover, excluding any method of proof other than certain proof based on medical research, could make it excessively difficult in many situations or, where it is common ground that medical research neither confirms nor rules out the existence of a causal link, impossible to establish producer liability, thereby undermining the effectiveness of the Directive and its objectives, which are to protect consumer health and safety and ensure a fair apportionment between the injured person and the producer of the risks inherent in modern technological production.

The Court nevertheless adds that national courts must ensure that the evidence adduced is sufficiently serious, specific and consistent to warrant the conclusion that, having regard also to the evidence produced and the arguments put forward by the producer, a defect in the product appears to be the most plausible explanation for the occurrence of the damage. National courts must also safeguard their own freedom of assessment in determining whether such proof has been made out to the requisite legal standard, until such time as they consider themselves in a position to draw a definitive conclusion on the matter.

In the present case, the Court considers that the temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered, appears on the face of it to constitute evidence which, taken together, may lead a national court to consider that a victim has discharged his burden of proof. That could be the case inter alia where that evidence leads the court to consider, first, that the administering of the vaccine is the most plausible explanation for the occurrence of the disease and, second, that the vaccine therefore does not offer the safety that one is entitled to expect.

The Court adds that it is not possible for the national legislature or the national courts to introduce a method of proof under which the existence of a causal link between the defect attributed to a vaccine and the damage suffered by the victim will automatically be established when certain predetermined causation-related factual evidence is presented, as that would have the consequence of the burden of proof provided for in the Directive being undermined.

 1 Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ 1985, L 210, p. 29). 

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Vaccination in acute humanitarian emergencies: a framework for decision making

World Health Organization, Geneva
June, 2017 :: 96 pages
PDF: http://apps.who.int/iris/bitstream/10665/255575/1/WHO-IVB-17.03-eng.pdf
EXECUTIVE SUMMARY
Humanitarian emergencies, regardless of type and cause, have a number of common risk factors for communicable diseases inextricably linked to excess risk of morbidity and mortality which can come from vaccine–preventable diseases (VPDs). The reduction of VPDs is a significant aim of public-health interventions during crises.

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization carried out a comprehensive review of evidence on vaccination decision-making processes and considerations in humanitarian emergencies. This review resulted with decision-making framework which provides a transparent, evidence-based, and rigorous methodology for deciding on vaccination options in acute humanitarian emergencies. It consists of three essential steps: 1) assessing the local epidemiological risks of VPDs among the affected population, 2) vaccine selection and characteristics to consider, and 3) local contextual constraints that further assist in effective and timely decisions. The diagram below provides a schematic representation of this three-step approach in decision-making process.

This framework is intended to guide decision making on vaccination interventions immediately after the onset or during planning in anticipation of a possible or likely acute emergency. It may be applied in emerging humanitarian emergencies, or crisis of short duration, and in long-standing crisis and conflicts resulting in protracted humanitarian emergencies. The concept of “acute” emergency does not imply that the emergency in itself is short-lived, as in a protracted crisis situations can emerge and be considered as “acute”. An acute emergency signifies a situation meeting one or more of the following conditions: sudden unplanned displacement of a large proportion of the population, direct exposure of the civilian population to new or exacerbated and sustained episodes of armed conflict, impending or already occurred sudden deterioration of nutritional status, natural or industrial disasters, and/or sudden breakdown of critical administrative and management functions which result in large-scale disruption of public health and related services.

This decision-making framework is intended for senior-level government and partner organization officials who are expected to work together to reach a decision regarding the need of vaccine antigen(s) in a given humanitarian emergency. It makes part of a package which also includes “Vaccination in Humanitarian Emergencies Implementation Guide”. Both documents are supported with electronic versions to ensure that the most up-to-date vaccine and disease-specific data, and references to additional information and guidance are provided.
 
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POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 21 June 2017 [GPEI]
:: In Syria, 15 new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in the past week, bringing the total number of cVDPV2 cases in the country to 17.  Sixteen of the 17 cases are from Mayadeen district, Deir-Al-Zour governorate, and one case is from Raqua district, Raqua governorate.  All cases had onset of paralysis between 3 March and 23 May.

:: The 14th report of the Independent Monitoring Board (IMB) has been published, following the group’s meeting in May.[see below]

:: Summary of newly-reported viruses this week:  Syria – 15 new circulating vaccine-derived poliovirus type 2 (cVDPV2) were isolated from acute flaccid paralysis (AFP) cases, and four new cVDPV2 isolated from healthy community contacts.  Pakistan – one new wild poliovirus type 1 (WPV1) isolated from an environmental sample

Weekly country updates as of 21 June 2017
:: Syrian Arab Republic

In Syria, 15 new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in the past week, bringing the total number of cVDPV2 cases to 17.  Sixteen of the 17 cases are from Mayadeen district, Deir-Al-Zour governorate, and one case is from Raqua district, Raqua governorate.  All cases had onset of paralysis between 3 March and 23 May.  Additionally, four cVDPV2s were also isolated from healthy community contacts, all from Mayadeen (collected in April and May).

Of a total of 65 acute flaccid paralysis (AFP) cases detected in Deir-Al-Zour since the start of 2017, 16 have now tested positive for cVDPV2 (with the 17th case from Raqua), 22 have tested negative, 5 are pending for final laboratory results and 22 specimens are en route to a laboratory for processing.

Confirmation of these latest cases is not unexpected at this time and does not change the operational situation, as outbreak response plans are being finalized, in line with internationally-agreed outbreak response protocols.  Although access to Deir-Al-Zour is compromised due to insecurity, the Governorate has been partially reached by several vaccination campaigns against polio and other vaccine-preventable diseases since the beginning of 2016. Most recently, two campaigns have been conducted in March and April 2017 using the bivalent oral polio vaccine (OPV). However, only limited coverage was possible through these campaigns.

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EVERY LAST VIRUS
INDEPENDENT MONITORING BOARD OF THE GLOBAL POLIO ERADICATION INITIATIVE – FOURTEENTH REPORT: JUNE 2017 :: 34 pages
PDF: http://polioeradication.org/wp-content/uploads/2017/06/14th-IMB-Report-FINAL.pdf
The Independent Monitoring Board provides an independent assessment of the progress being made by the Global Polio Eradication Initiative in the detection and interruption of polio transmission globally. This report follows the IMB’s meeting held in London on 2 and 3 May
2017.

[Excerpt]
CONCLUSIONS AND RECOMMENDATIONS [p.20]
The Polio Programme has reached a level of performance where there is room for optimism that 2017 will be the year when poliovirus transmission globally is permanently interrupted. Nigeria has a strong programme that pioneered the use of an Emergency Operations Centre to integrate a diverse range of partners to drive up the level of performance. Pakistan has benefitted from the exceptional leadership of the Health Minister and the Prime Minister’s Focal Person on Polio Eradication. The transformation of the Polio Programme in that country from being judged “a disaster” in a previous IMB report is quite remarkable. The Afghanistan Programme has done well to achieve what it has despite serious problems of access due to conflict.

All this is commendable, but the Polio Programme in the three endemic countries and globally is not there yet. The optimism must be tempered with a realism about the risks and challenges that remain. Only if the appropriate balance is struck can the programme succeed soon.

If the narrative and statistical analysis in this IMB Report is read carefully, five major priorities for action jump out:
:: An innovative and transformational solution must be found to vaccinate the large numbers of so-called “Guest children” who are within the large high-risk mobile population in Pakistan; continuing with the current approach will not reduce the numbers of “still missed” children from hundreds of thousands to hundreds in less than six months.

:: A dramatic and immediate turnaround is needed in the low level of routine immunisation coverage in the polio reservoirs in Pakistan and Afghanistan; the current position is a stain on the Programme’s record of improved performance.

:: The Nigeria Programme has not yet realised that it must become an exemplar in how to operate as a high resilience enterprise; all its efforts should be directed to strengthening the defenses against any poliovirus breaking through.

:: The whole region around northern Nigeria, Lake Chad and surrounding countries has become a red zone in which there is a high-risk of the re-emergence of circulating poliovirus; leaders at the highest political level should be on full alert and completely engaged.

:: The quality and integrity of surveillance data across the Polio Programme, particularly in northern Nigeria and other parts of Africa, which may harbour another unwelcome, long-unrecognised outbreak, is not what it should be. This is compromising the ability of the Polio
Programme to be sure that transmission has ended.

These are major problems threatening the successful completion of polio eradication. They are problems awaiting solutions. The tried and trusted methods that are being used are still necessary but matching these problems with solutions that bring transformation is the missing ingredient….
[10 action recommendations follow]

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Emergencies

Emergencies

WHO Grade 3 Emergencies  [to 24 June 2017]
Iraq 
:: Iraq: Special health health situation report on Mosul crisis
17 June 2017 — WHO in coordination with Erbil and Ninewa Directorates of Health (DOH) on 13 June 2017 rapidly responded to suspected food borne illness outbreak in Hassan Sham U2 camp by conducting an investigation with the aim to identify the source and cause of the outbreak, treat those ill as well as contain and prevent any spread. WHO delivered 500 rapid diagnostic test kits (RDT) to Ninewa DoH and primary health care facilities in Qayyarah, Hammam al’Alil and Salamiyah, to support the response to any future cholera outbreaks in the Governorate of Ninewa including camps and host communities. WHO donated to health partners emergency medical supplies enough to serve the needs of more than 20500 persons in Al Salamiyah camp.

The Syrian Arab Republic 
:: More than 12 000 treatments delivered to Ein Issa and Karameh camps in Al-Raqqa governorate
22 June 2017 – The World Health Organization (WHO) has responded to an acute shortage of life saving medicines by dispatching a shipment of more than 12 000 treatments to the 2 main camps for internally displaced persons in rural Al-Raqqa. This shipment will support treatment of patients with chronic conditions, infectious diseases and diarrhoeal diseases who lack adequate access to medical care.

Nigeria
:: Overview of WHO operations in north eastern Nigeria
June 2017 —WHO has decided to adopt a sub-regional approach across the four Lake Chad basin affected countries, to increase its interventions, which will address the health needs of the displaced populations and host communities alike.

South SudanNo new announcements identified.
YemenNo new announcements identified.
 

WHO Grade 2 Emergencies  [to 24 June 2017]
Democratic Republic of the Congo
:: Ebola Situation report: 20 June 2017
…On 19 June 2017, no new confirmed, probable cases or suspected have been reported since the last situa­tion update on 15 June. Seven alerts have been reported and investigated and none fulfilled the suspected case definition…

Cameroon  No new announcements identified
Central African Republic  – No new announcements identified. 
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified
 
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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Hundreds of civilians are being killed and injured as fighting intensifies in Mosul’s old city
(Baghdad, 24 June 2017) – The United Nations strongly condemns recent incidents resulting in the terrible loss of civilian life including the 23 June attacks in eastern Mosul and in Mushahada in the old city of Mosul where as many as 12 civilians were killed and possibly hundreds injured.
“Killing and wounding civilians violates every humanitarian principle and is contrary in every way to international humanitarian law,” said Lise Grande, Humanitarian Coordinator for Iraq.
“We are shocked and deeply saddened by the tragic loss of life that has occurred during the fighting in Mosul and we extend our heartfelt condolences to the families of all the victims,” said Ms. Grande, the Humanitarian Coordinator for Iraq…

Syrian Arab Republic
:: 23 Jun 2017  Syria – Regional: Emergency Dashboard, June 2017

YemenNo 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.
Somalia
:: Somalia: Drought Response – Situation Report No. 13 (as of 20 June 2017)

Ethiopia
:: 20 Jun 2017  Ethiopia Weekly Humanitarian Bulletin, 19 June 2017

DRC (Kasai crisis)No new announcements identified.
NigeriaNo new announcements identified.

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War-Torn Yemen to Get Cholera Vaccines as Death Toll Mounts
New York Times/ASSOCIATED PRESS
JUNE 21, 2017
GENEVA — The U.N. health agency and some major partners have agreed to send 1 million doses of cholera vaccine to Yemen to help stanch a spiraling and increasingly deadly caseload in the impoverished country, which is already facing war and the risk of famine.
A spokesman for the World Health Organization said Wednesday that it didn’t initially want to publicize last week’s decision because questions remain about when and how the doses could reach the neediest people in a country sliced up along front lines and grappling with a nearly-collapsed health system.
WHO said the 1 million doses for Yemen were approved on June 15 by the International Coordinating Group, which manages vaccine stocks and includes the Red Cross, Doctors Without Borders, UNICEF, and Gavi, the Vaccine Alliance along with WHO. Such a shipment would be the largest since 1 million doses were sent to Haiti after Hurricane Matthew last fall — and would amount to about half of the usual world stockpile, which would then be replenished.
…Now, in just over two months, the cholera outbreak has taken over 1,100 lives and the caseload is rising, with peak levels unpredictable, WHO says…
…”The fact that over a thousand people have died during this rapidly spreading cholera outbreak is shocking,” said Dr. Seth Berkley, CEO of Gavi, in an e-mail. “We cannot underestimate the huge logistical challenges of delivering vaccines in a warzone where the health system, as well as basic infrastructure, has been all but destroyed.”
Berkley said the doses could help slow the spread of the disease as part of a broader strategy to contain it…

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UNICEF  [to 24 June 2017]
https://www.unicef.org/media/media_94367.html
23 June 2017
5.6 million children at risk of waterborne diseases as rainy season hits communities affected by Lake Chad crisis
DAKAR/ GENEVA/ABUJA, 23 June 2017 – More than 5.6 million children are at increased risk of contracting waterborne diseases, such as cholera and diarrheal infections, as the rainy season begins in conflict-affected areas of countries around Lake Chad, UNICEF warned today. The threat of disease outbreaks in Cameroon, Chad, Niger and Nigeria coincides with growing regional insecurity and increased population movements particularly in Nigeria’s northeast.

Crisis ‘far from over’ as malnutrition, thirst and disease threaten lives of millions of children in north-east Nigeria, Somalia, South Sudan and Yemen
NEW YORK/DAKAR/NAIROBI/AMMAN, 23 June 2017 – The welcome announcement of an end to famine conditions in South Sudan this week should not distract from the fact that severe food insecurity continues to put the lives of millions of children at risk in north-east Nigeria, Somalia, South Sudan and Yemen, UNICEF warned today.

Nowhere To Go: Children in Iraq trapped in cycles of violence and poverty as conflict reaches unprecedented levels
BAGHDAD/NEW YORK, 22 June 2017 – Three years since the intensification of violence in Iraq, children are trapped in an endless cycle of violence and increasing poverty, according to a UNICEF assessment, Nowhere to Go.

South Sudan famine ebbs, but situation still desperate as hunger spreads
ROME/JUBA, South Sudan, 21 June 2017 – Famine has eased in South Sudan after a significant scale up in the humanitarian response, according to new analysis released today. However, the situation remains dire across the country as the number of people struggling to find enough food each day has grown to six million – up from 4.9 million in February – and is the highest level of food insecurity ever experienced in South Sudan.

South Sudan refugee crisis: Over 1,000 children fleeing violence and instability every day
KAMPALA/NAIROBI/NEW YORK, 20 June 2017 – As more than 1,000 children continue to flee South Sudan, on average every day in search of safety, the region’s refugee crisis has become a children’s crisis, UNICEF said today, on World Refugee Day.

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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 24 June 2017]
http://www.who.int/ebola/en/
WHO AFRO
Ebola Situation report: 20 June 2017 
…On 19 June 2017, no new confirmed, probable cases or suspected have been reported since the last situa­tion update on 15 June. Seven alerts have been reported and investigated and none fulfilled the suspected case definition…

MERS-CoV [to 24 June 2017]
http://www.who.int/emergencies/mers-cov/en/
DONs- Disease Outbreak News
Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia
19 June 2017
Between 11 and 15 June 2017, the national IHR Focal Point of Saudi Arabia reported 14 additional cases of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection including one fatal case among previously reported cases…
 
 
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WHO & Regional Offices [to 24 June 2017]

WHO & Regional Offices [to 24 June 2017]

New WHO advisory group launched in Almaty to shape the future of primary health care
20-06-2017
Experts convened in Almaty, Kazakhstan, on 20–21 June 2017 for the inaugural meeting of the Primary Health Care Advisory Group. The WHO Regional Director for Europe launched the Advisory Group to advance primary health care in the WHO European Region.
At its first meeting, the Advisory Group engaged in discussions on the readiness and responsiveness of primary health care to embrace future health and social needs…

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Highlights
Inaugural Africa Health Forum in Kigali, Rwanda
June 2017 – For the first time, WHO’s Regional Office for Africa is convening global leaders and thinkers to explore Africa’s healthcare priorities and challenges and find new ways to achieve better health for all.

More can be done to restrict sunbeds to prevent increasing rates of skin cancer
   June 2017 – WHO underscores national actions to limit the use of artificial tanning devices (sunbeds) in a bid to reduce the associated health risks, such as melanoma and non-melanoma skin cancers. For more than three decades, the deliberate sunbed exposure to ultraviolent radiation (UVR) for cosmetic purposes has been driving up the incidence of skin cancers and driving down the age of their first appearance.

WHO toolkit for the care and support of people affected by complications associated with Zika virus
June 2017 – Zika virus is associated with severe neurological complications, particularly congenital Zika virus syndrome and Guillain Barré syndrome. The associated complications have a marked impact on the people affected and their communities, including both physical and mental health. The toolkit has been developed to serve as a model guide, with the goal of enhancing country preparedness for Zika virus outbreaks.

Paris is 500th member of WHO Global Network for Age-friendly Cities and Communities
June 2017 – Today, 19 June, WHO’s Global Network for Age-friendly Cities and Communities (GNAFCC) welcomed Paris, France, as its 500th member. The Mayor of Paris, Anne Hidalgo and her deputy Dominique Versini – responsible for early childhood, the protection of children and the fight against exclusion and the elderly – formalised their commitment to become an age-friendly city during a presentation of the plan “2017-2021 Seniors in Paris”.

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Weekly Epidemiological Record, 23 June 2017, vol. 92, 25 (pp. 345–356)
:: Yellow fever vaccine: WHO position on the use of fractional doses – June 2017
:: Global polio eradication: progress towards containment of poliovirus type 2, worldwide
2017

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO AFRO to host the inaugural Africa Health Forum in Kigali, Rwanda  Brazzaville, 21 June 2017

WHO Region of the Americas PAHO
No new digest content identified.

WHO South-East Asia Region SEARO
:: International Day of Yoga   20 June 2017
 
WHO European Region EURO
:: New WHO advisory group launched in Almaty to shape the future of primary health care 20-06-2017
:: World Refugee Day: WHO training enables Syrian doctors and nurses to provide health care in Turkey 19-06-2017
:: European countries promote #SlowDown campaign for UN Global Road Safety Week 19-06-2017

WHO Eastern Mediterranean Region EMRO
:: WHO expresses thanks and appreciation to His Royal Highness, Crown Prince of Saudi Arabia, for his generous initiative to fund cholera response activities in Yemen  23 June 2017
:: World Refugee Day: WHO training enables Syrian doctors and nurses to provide health care in Turkey  19 June 2017

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CDC/ACIP [to 24 June 2017]

CDC/ACIP [to 24 June 2017]
http://www.cdc.gov/media/index.html
Media Advisory
Thursday, June 22, 2017
CDC Hosts Media Availability for New Ebola Exhibition

Media Statement
Tuesday, June 20, 2017
CDC surveys find increase in the number of U.S. counties with Aedes aegypti and Aedes albopictus mosquitoes that can spread Zika
The Southern United States shows a substantial increase in the number of counties that reported evidence of the mosquitoes that can spread chikungunya, dengue, and Zika viruses, according to new research by the Centers for Disease Control and Prevention (CDC) published in the Journal of Medical Entomology June 19.

MMWR – June 22, 2017
:: Evaluation of Placental and Fetal Tissue Specimens for Zika Virus Infection — 50 States and District of Columbia, January–December, 2016
:: Screening for Syphilis and Other Sexually Transmitted Infections in Pregnant Women — Guam, 2014
:: Global Polio Eradication: Progress Toward Containment of Poliovirus Type 2 — Worldwide 2017

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Announcements

Announcements
 
NIH  [to 24 June 2017]
http://www.nih.gov/news-events/news-releases
June 19, 2017
Study to examine effects of Zika infection in Guatemalan infants and children
— NIH-funded study will characterize outcomes of infection acquired after birth.
A large natural history study examining the neurologic, neurodevelopmental and other clinical outcomes of Zika virus infection in infants and young children has begun in rural Guatemala. It will focus on those infected with Zika virus after birth rather than those infected congenitally. The study is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, in partnership with FUNSALUD (Fundacion para la Salud Integral de los Guatemaltecos) Center for Human Development in Coatepeque, Guatemala, a nonprofit foundation dedicated to improving the health and human development of families and communities in the southwest region of Guatemala. Researchers in Guatemala and the United States, including NIAID scientists, designed the study; NIAID is funding the research….

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European Medicines Agency  [to 24 June 2017]
http://www.ema.europa.eu/ema/
23/06/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017
Eight medicines recommended for approval, including two medicines for chronic hepatitis C virus (HCV) infection
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval at its June meeting.
The CHMP recommended granting marketing authorisations for Maviret (glecaprevir / pibrentasvir) and Vosevi (sofosbuvir / velpatasvir / voxilaprevir) for the treatment of chronic hepatitis C virus (HCV) infection. Both medicines were reviewed under the EU’s accelerated assessment mechanism…
 
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EDCTP    [to 24 June 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
19 June 2017
Professor Alimuddin Zumla honoured for services to public health
Professor Alimuddin Zumla, Professor of Infectious Diseases and International Health at University College London was honoured in the United Kingdom for services to public health and protection from infectious disease with a Knighthood (KBE) in Her Majesty The Queen’s 2017 Birthday Honours List…

19 June 2017
Mundo Sano joins forces with EDCTP to fund research on neglected infectious diseases
On 16 June 2017, the Mundo Sano Foundation and the European & Developing Countries Clinical Trials Partnership (EDCTP) created a partnership to leverage research funding for neglected infectious diseases (NIDs). They agreed that Mundo Sano would contribute to clinical and product-focused implementation research in neglected diseases and soil-transmitted helminthiases.
 
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UNAIDS  [to 24 June 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Feature story – 22 June 2017
New survey finds high levels of HIV discrimination in Republic of Korea
…A new survey conducted by the Korean Network of People Living with HIV/AIDS (KNP+) finds that Mr Cho’s experience is far too common for people living with HIV in the Republic of Korea. The Korean People Living with HIV Stigma Index, which is the first peer-led survey in the country to detect and measure how HIV-positive people experience stigma and discrimination, was released on 22 June. Its development was supported by the Global Network of People Living with HIV, the International Community of Women Living with HIV and UNAIDS.
The survey, which was conducted from March to June 2016, found that 62% of people questioned reported that they were tested for HIV without their knowledge. This is high compared to other countries in Asia that have conducted similar peer-led surveys. In Viet Nam, 13% of people living with HIV reported similar experiences and in Nepal the figure was 9%. In addition, 17% of people surveyed in the Republic of Korea said their status was disclosed by medical staff to others without their consent.
“For too long, the voices of people living with HIV have been absent in policy-making,” said Son Mun Soo of KNP+. “This study documents their experiences and shows that the government, employers, health-care workers and communities must do much more to guarantee the rights of people living with HIV. A comprehensive anti-discrimination law must be enacted to protect their rights.”
UNAIDS and the World Health Organization strongly recommend that HIV testing only be undertaken with a person’s informed consent…
 
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MSF/Médecins Sans Frontières  [to 24 June 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Addition of Snakebite to WHO’s Neglected Tropical Diseases List Could Spur New, More Effective Treatments
June 23, 2017
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) welcomed the addition of snakebite to the World Health Organization’s (WHO) Neglected Tropical Diseases (NTD) list. Despite the fact that snakebite is estimated to kill over 100,000 people every year—more than any other disease on the list— there are hardly any resources to prevent and treat it and very few lifesaving anti-venoms available.
 
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Wellcome Trust  [to 24 June 2017]
https://wellcome.ac.uk/news
Opinion / Published: 20 June 2017
Director’s update: our priorities for the Brexit negotiations
As the formal negotiations on the UK’s exit from the European Union begin in Brussels, Wellcome’s Director Jeremy Farrar outlines what science needs to thrive post-Brexit.
In an article in today’s Times, he sets out three key things that the government should prioritise during the negotiations to sustain Britain’s status as a world-leading centre for science:
:: harmonised regulation between the UK and the EU on issues such as medicines and data protection, to create the right conditions for innovative industries to thrive
:: continued access to EU research funding schemes for UK scientists
: an immigration policy that is welcoming to foreign researchers, technicians, innovators and their families, at every stage of their career, and to students.

News / Published: 19 June 2017
Awards for the Wellcome community in the Queen’s Birthday Honours
Several members of the Wellcome community have been named in the Queen’s Birthday Honours list. The list, which was announced over the weekend, includes over 1,000 people who are recognised for their achievements and contributions to society…
 
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Industry Watch
:: Pfizer Begins Phase 1 Clinical Trial to Evaluate Investigational Group B Streptococcus Vaccine
An estimated 10 to 30 percent of pregnant women carry the GBS bacteria;1 the vaccine candidate is being studied to help protect newborns from infection via maternal immunization
June 19, 2017
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1 trial in healthy volunteers of PF-06760805, an investigational vaccine designed to help protect against Group B Streptococcus (GBS) infection. In newborns, GBS manifests as sepsis, pneumonia, and meningitis,2 with potentially fatal outcomes for some, and long-lasting neurological damage in 46 to 50 percent of those infected.3
“Because their immune systems are still immature, GBS can have potentially devastating effects on newborns,” said Carol J. Baker, M.D., Professor of Pediatrics-Infectious Disease at the Baylor College of Medicine in Houston, Texas. “The global health community would welcome a vaccine that could help reduce the impact of GBS everywhere, particularly in areas where the routine administration of antibiotics is not common practice.”
Women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. The U.S. and certain developed countries have established recommendations for women to be screened for GBS during their third trimester of pregnancy, and administered prophylactic antibiotics during labor to prevent transmission to their newborns at delivery.4,5 However, this requires a robust health delivery infrastructure that is not widely available globally.
“Pfizer is proud to take this important first step to support our efforts to ultimately develop a GBS vaccine with the potential to immunize a mother to help protect her infant against a devastating disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. …
 
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Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

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

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

 
Integrating Clinical Research into Epidemic Response: The Ebola Experience (2017)
Consensus Study Report
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Global Health; Board on Health Sciences Policy; Committee on Clinical Trials During the 2014-2015 Ebola Outbreak; Gerald Keusch, Keith McAdam, Patricia Cuff, Michelle Mancher, and Emily R. Busta, Editors
June 2017 :: 310 pages
PDF: https://www.nap.edu/login.php?record_id=24739&page=https%3A%2F%2Fwww.nap.edu%2Fdownload%2F24739
Description
The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014–2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak.

Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014–2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

The Lancet
Jun 24, 2017 Volume 389 Number 10088 p2443-2586  e16
http://www.thelancet.com/journals/lancet/issue/current
Comment
Clinical trials during epidemics
Gerald T Keusch, Keith P W J McAdam
The consensus report of the US National Academies of Sciences, Engineering and Medicine for the first time evaluates the clinical trials on Ebola therapeutics and vaccines in Guinea, Sierra Leone, and Liberia during 2014–15.1 The report presents seven recommendations for both interepidemic and epidemic periods to improve the likelihood that important new information on therapeutics and vaccines can be obtained during future epidemics. This information is especially critical for infections such as Ebola virus disease because the only time efficacy and safety of drugs or vaccines can be studied in infected or at-risk human beings is during an outbreak. The recommendations are based on analysis of what happened in west Africa, and fall into three main categories: capacity strengthening, engaging communities, and international coordination and collaboration.

Strengthening capacity in countries at risk of emerging epidemics to respond more effectively to outbreaks and evaluate unproven new drugs and vaccines seems obvious. Planning of trials should begin when effective outbreak surveillance and reporting identify an outbreak in progress, as mandated by the International Health Regulations of 2005.2 Although WHO is responsible for assuring the latter core competencies are achieved, without international experts and sufficient available donor funding WHO cannot meet its obligations. To be both effective and efficient, clinical trials research expertise must involve not only training researchers, but also integrating research within a health-care system, improving infrastructure for competent scientific and ethical review of human subject research, and establishing the capability to negotiate legal documents with trial sponsors.

The local health-care system in Guinea recognised and reported an unusual cluster of rapidly fatal illness in the Forestière region by mid-January, 2014, but the Ministry of Health was unable to identify the actual cause. Another 8 weeks elapsed before Ebola was confirmed, during which time the outbreak grew and spread to two additional countries and multiple urban centres.3 In the scramble to respond to meet basic care needs and halt transmission, the possibility to assess experimental drugs and vaccines received little attention until 5 months later when WHO declared a public health emergency of international concern.4 Despite herculean efforts to build necessary infrastructure and launch trials in record time, limited local experience with clinical research and poor capacity for timely scientific and ethical review or negotiation of research contracts, together with differing views of trial design and probable community reaction among local and international stakeholders, slowed the process.5

Unfortunately, record time was not fast enough: the nine formal clinical trials the committee evaluated all began as the outbreak was waning. The report describes the consequence as a “thin scientific harvest”,1 and 2 years later no licenced product is available. Strengthening the many areas of expertise required for clinical trials takes sustained effort, time, and funding before an outbreak strikes. The report concludes that the choice is to “pay now and prepare in advance, or to pay later when an outbreak occurs, with the likelihood that the cost will be multiple times greater”.1

Engaging local communities emerged as a complementary concern. Clinical trials require volunteers to participate, but in the context of an uncontrolled outbreak patients may not only be ill and inadequately informed, but also fearful, vulnerable, stigmatised, and confused about goals, benefits, and risks of trials. The relationship between researcher and participant, which depends on mutual trust, was difficult to achieve in west Africa, a region haunted by the memory of civil wars and ongoing distrust of authority, compounded by limited understanding among international researchers of local culture and social traditions.6 In the absence of trust, misunderstanding was the norm and resistance was the early response in affected communities. Building trusting relationships requires time and expertise in social science and communication.7 Despite early controversies about the ethics of doing trials during an emergency and assumptions that randomised controlled trials were unacceptable, and therefore nobody would volunteer,8 once community leaders and the community itself were effectively engaged, randomised controlled trials were successfully implemented.6, 9 The research community must learn how to accomplish this engagement more efficiently in the future.

International coordination and cooperation are essential to avoid the conflict and competition that will inevitably arise again when the next outbreak occurs. This coordination requires pre-emptive joint efforts among international and national stakeholders, including the humanitarian response, research and development, and clinical trials communities, to integrate research into response, have therapeutic and vaccine candidates ready to go, and agree on principles and processes to speed priority setting, and design, approval, and implementation of clinical trials. The report recommends such efforts be led by a Coalition of International Stakeholders, which is purpose-built, independent, free of conflicts of interest, possesses expertise in many disciplines, and includes representation from governments, WHO, academia, the private sector, humanitarian response organisations, and the countries and communities at risk. The coalition would need secure financial resources to lead the effort to establish necessary global mechanisms and commitments. It should have the responsibility and resources to convene an expert, independent Rapid Research Response Workgroup at the outset of a new outbreak, including national and community participants from affected countries, to prioritise which candidates to study, determine appropriate trial design, and facilitate implementation. The report concludes: “If national and international researchers can work together on a collaborative and coordinated research agenda, and include input from the population at risk, the global community has the best chance at being prepared for the next outbreak.”1 The time to act on these recommendations is now.

The next step is to engage the many stakeholders across continents, including WHO, the World Bank, UN system, governments, research-funding agencies and foundations, academic institutions, humanitarian and civil society organisations, and others, in thoughtful discussion to determine the best way forward.

The US National Academies of Sciences, Engineering and Medicine and former members of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak are reaching out to key stakeholders to stimulate these efforts through presentations, publications, and personal contacts. Major questions remain to be resolved. How can we systematically integrate clinical and social science research expertise with emergency response? Can we create a tool box with model study designs for different outbreak scenarios, pathways for community engagement, tutorials on ethical guidelines, and more, and provide training for future leaders in countries at particular risk for emerging infections in their use, and so speed action when an epidemic begins? What is the best governance model and the particular role of WHO? Who will take leadership and where will the funds and political will come from? The answers to these questions will guide these efforts to refresh the necessary collaborative global leadership, help it to thrive, and ensure it is held to account.

We were Co-Chairs of the US National Academies of Sciences, Engineering, and Medicine’s Committee on Clinical Trials During the 2014–2015 Ebola Outbreak. We declare no other competing interests.

The other members of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak were: Abdel Babiker, Mohamed Bailor Barrie, Janice Cooper, Sheila Davis, Kathryn Edwards, Susan Ellenberg, Roger Lewis, Alex John London, Jens Lundgren, Michelle Mello, Olayemi Omotade, David Peters, Fred Wabwire-Mangen, and Charles Wells. National Academies of Sciences, Engineering, and Medicine study staff were: Patricia Cuff, Michelle Mancher, Emily Busta, Michael Berrios, Anne Claiborne, Julie Pavlin, and Andrew Pope.

References
US National Academies of Sciences, Engineering and Medicine. ((accessed June 12, 2017).)Committee on Clinical Trials During the 2014–2015 Ebola Outbreak. Integrating clinical research into epidemic response: the Ebola experience. The National Academies Press, Washington, DC; 2017
https://www.nap.edu/catalog/24739/integrating-clinical-research-into-epidemic-response-the-ebola-experience

Journal Watch

Journal Watch

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

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

Assessing the impact of health research on health policies: a study of the Dodowa Health Research Centre, Ghana

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 24 June 2017)

Research article
Assessing the impact of health research on health policies: a study of the Dodowa Health Research Centre, Ghana
The importance of assessing research impact is increasingly recognised. Ghana has a long tradition of research dating from the 1970s. In the Ghana Health Service there are three health research centres under t…
Blanca Escribano-Ferrer, Jayne Webster and Margaret Gyapong
BMC Health Services Research 2017 17:435
Published on: 24 June 2017

Comparative effectiveness research: what to do when experts disagree about risks

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 24 June 2017)

Debate
Comparative effectiveness research: what to do when experts disagree about risks
Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research.
Reidar K. Lie, Francis K.L. Chan, Christine Grady, Vincent H. Ng and David Wendler
BMC Medical Ethics 2017 18:42
Published on: 19 June 2017

Bangladesh policy on prevention and control of non-communicable diseases: a policy analysis

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 24 June 2017)

Research article
Bangladesh policy on prevention and control of non-communicable diseases: a policy analysis
This paper is aimed at critically assessing the extent to which Non-Communicable Disease NCD-related policies introduced in Bangladesh align with the World Health Organization’s (WHO) 2013–2020 Action Plan for…
Tuhin Biswas, Sonia Pervin, Md. Imtiaz Alam Tanim, Louis Niessen and Anwar Islam
BMC Public Health 2017 17:582
Published on: 19 June 2017

Achieving sustainability in health information systems: a field tested measure of country ownership

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 24 June 2017]

Methodology
Achieving sustainability in health information systems: a field tested measure of country ownership
A country will trust, value, and use, its health information system (HIS) to the extent it has had a role in its creation and maintenance. A sense of ownership contributes in turn to the long-term sustainabili…
Stephanie Watson-Grant, Khou Xiong and James C Thomas
Globalization and Health 2017 13:36
Published on: 24 June 2017

New Leader, New Era: Five Building Blocks For A Reinvigorated World Health Organization

Health Affairs
June 2017; Volume 36, Issue 6
http://content.healthaffairs.org/content/current
Issue Focus: Pursuing Health Equity

[Reviewed earlier]

Blog
New Leader, New Era: Five Building Blocks For A Reinvigorated World Health Organization
19 June 2017
By Lawrence O. Gostin
The World Health Assembly’s election of Tedros Adhanom Ghebreyesus to serve as its 9th Director-General may be the most momentous in the Organization’s 70 years for reasons far beyond electing the first African. The World Health Organization (WHO) faces a crisis in confidence following its anemic response to Ebola. It remains caught in an unvirtuous cycle: Member State loss of trust results in a paucity of funding and the continual inability to perform. This is a moment to take stock of the new Director-General’s record and vision, as well as the reforms needed to transform WHO into the 21st century institution the world sorely needs…
…Guided by an unyielding insistence upon and institutionalization of human rights, demanding and developing mechanisms for WHO Secretariat and Member State accountability, and unwavering commitment to the public’s health over politics, Dr. Tedros could return WHO to global health leadership. Too much is at stake for him to do otherwise, while states and stakeholders must do everything possible to make his tenure a historic success.