Science         
22 June 2018  Vol 360, Issue 6395
http://www.sciencemag.org/current.dtl

Editorial
Emerging stem cell ethics
By Douglas Sipp, Megan Munsie, Jeremy Sugarman
Science22 Jun 2018 : 1275
Summary
It has been 20 years since the first derivation of human embryonic stem cells. That milestone marked the start of a scientific and public fascination with stem cells, not just for their biological properties but also for their potentially transformative medical uses. The next two decades of stem cell research animated an array of bioethical debates, from the destruction of embryos to derive stem cells to the creation of human-animal hybrids. Ethical tensions related to stem cell clinical translation and regulatory policy are now center stage and a topic of global discussion this week at the International Society for Stem Cell Research (ISSCR) annual meeting in Melbourne, Australia. Care must be taken to ensure that entry of stem cell–based products into the medical marketplace does not come at too high a human or monetary price.

Science         
22 June 2018  Vol 360, Issue 6395
http://www.sciencemag.org/current.dtl

In Depth
U.S. center will fight infections with viruses
By Kelly Servick
Science22 Jun 2018 : 1280-1281 Restricted Access
Proving ground for phage therapy will organize full clinical trials of the approach.
Summary
In the fight against antibiotic-resistant infections, a decades-old approach based on bacteria-slaying viruses called phages has been sidelined by technical hurdles, dogged by regulatory confusion, and largely ignored by drug developers in the West. But 2 years ago, researchers at the University of California, San Diego (UCSD), used phages to knock out an infection that nearly killed a colleague. Propelled by that success and a handful of others since, UCSD is now launching a clinical center to refine phage treatments and help companies bring them to market. The center, a first in North America, aims to be a proving ground for a treatment that has long been available in parts of Eastern Europe, but that still lacks the support of rigorous clinical trials.

Vaccine
Volume 36, Issue 28   Pages 3993-4152 (27 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/28

Commentaries
Quadrivalent influenza vaccines in low and middle income countries: Cost-effectiveness, affordability and availability
Open access
Pages 3993-3997
Jan Hendriks, Raymond C.W. Hutubessy, Gary Grohmann, Guido Torelli, … Marie-Paule Kieny

Vaccine
Volume 36, Issue 28   Pages 3993-4152 (27 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/28

Mandatory influenza vaccination and religious accommodation for healthcare workers: Lessons from recent legal challenges
Pages 3998-4000
Tony Yang, Ross D. Silverman

Vaccine
Volume 36, Issue 28   Pages 3993-4152 (27 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/28

Assessing population immunity for measles elimination – The promise and peril of serosurveys
Pages 4001-4003
D.N. Durrheim, W.A. Orenstein, W.W. Schluter

Vaccine
Volume 36, Issue 28   Pages 3993-4152 (27 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/28

Regular Papers
Implementation of maternal influenza immunization in El Salvador: Experiences and lessons learned from a mixed-methods study
Original research article
Pages 4054-4061
Jessica A. Fleming, Rafael Baltrons, Elizabeth Rowley, Isabel Quintanilla, … Niranjan Bhat

Vaccine
Volume 36, Issue 28   Pages 3993-4152 (27 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/28

‘What have you HEARD about the HERD?’ Does education about local influenza vaccination coverage and herd immunity affect willingness to vaccinate?
Open access – Original research article
Pages 4118-4125
Jacqueline Logan, Dawn Nederhoff, Brandon Koch, Bridget Griffith, … Nicole E. Basta

Vaccine
Volume 36, Issue 28   Pages 3993-4152 (27 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/28

Barriers and facilitators to HPV vaccination among rural Alabama adolescents and their caregivers
Original research article
Pages 4126-4133
Erin D. Boyd, Janice M. Phillips, Yu-Mei M. Schoenberger, Tina Simpson

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

Expert Review of Vaccines
Accepted author version posted online: 18 Jun 2018
A decade of experience with rotavirus vaccination in the United States–vaccine uptake, effectiveness, and impact
T Pindyck, JE Tate, UD Parashar
Abstract
Introduction: Prior to 2006, nearly every U.S child was infected with rotavirus by 5 years of age, and rotavirus was the leading cause of severe childhood gastroenteritis. In February 2006 and June 2008, the Advisory Committee on Immunization Practices recommended a live attenuated pentavalent rotavirus vaccine (RV5) and a monovalent rotavirus vaccine (RV1), respectively, for routine vaccination of infants in the U.S.
Areas covered: We reviewed U.S. data on coverage, vaccine effectiveness (VE), and vaccine impact from 2006-2017. National rotavirus vaccine coverage estimates increased since vaccine introduction but plateaued at 71%-75% in 2013-2015, a level 15%-20% lower than that of other routine childhood vaccines. Pooled VE of full series RV5 and RV1 against rotavirus-associated hospitalizations and emergency department visits were 84% (95% CI: 80%-87%) and 83% (95% CI: 72%-89%), respectively. Vaccine introduction resulted in a median decline in rotavirus-associated hospitalizations and ED visits of 80% and 57%, respectively, along with indirect protection of unvaccinated age groups and a decrease in health care costs. A biennial pattern in rotavirus detection emerged post-vaccine implementation.
Expert Commentary: The increasing use of rotavirus vaccines has substantially diminished the burden and changed the epidemiology of rotavirus disease in US children; efforts to increase rotavirus vaccine coverage should continue.

Emerging Infectious Diseases
01 Jul 2018, 24(7):1178-1187
Progress in Vaccine-Preventable and Respiratory Infectious Diseases-First 10 Years of the CDC National Center for Immunization and Respiratory Diseases, 2006-2016
A Schuchat, LJ Anderson, LE Rodewald, NJ Cox…
Abstract
The need for closer linkages between scientific and programmatic areas focused on addressing vaccine-preventable and acute respiratory infections led to establishment of the National Center for Immunization and Respiratory Diseases (NCIRD) at the Centers for Disease Control and Prevention. During its first 10 years (2006-2015), NCIRD worked with partners to improve preparedness and response to pandemic influenza and other emergent respiratory infections, provide an evidence base for addition of 7 newly recommended vaccines, and modernize vaccine distribution. Clinical tools were developed for improved conversations with parents, which helped sustain childhood immunization as a social norm. Coverage increased for vaccines to protect adolescents against pertussis, meningococcal meningitis, and human papillomavirus-associated cancers. NCIRD programs supported outbreak response for new respiratory pathogens and oversaw response of the Centers for Disease Control and Prevention to the 2009 influenza A(H1N1) pandemic. Other national public health institutes might also find closer linkages between epidemiology, laboratory, and immunization programs useful.

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 23 Jun 2018
Health
How Will Trump Lead During the Next Global Pandemic? – The Atlantic
“There is a real reason for us to be scared,” President Obama’s Ebola czar said.
Krishnadev Calamur
The next global epidemic is likely around the corner—and no amount of U.S. retrenchment from globalization will halt that outbreak at the U.S. border.
“There is a real reason for us to be scared of the idea of facing this threat with Donald Trump in the White House,”said Ron Klain, who served as President Obama’s Ebola czar, at the Aspen Ideas Festival, which is cohosted by The Aspen Institute and The Atlantic. Klain said the “president is anti-science” and “trades in conspiracy theories.”
“All those things would lead to the loss of many lives in the event of an epidemic in the United States where we need the public not to trade in conspiracy theories, not to believe that the news was fake, but to respect scientific expertise,” said Klain, a veteran Democratic operative who served in both the Clinton and Obama administration…

Financial Times
http://www.ft.com/home/uk
Accessed 23 Jun 2018
Salvini ramps up rhetoric with attack on mandatory vaccines
23 June 2018
Matteo Salvini, the leader of Italy’s far-right League, has dismissed mandatory vaccinations as “useless and in many cases dangerous” as he extended a streak of provocative statements since taking power as the dominant figure of the new populist government.
In a radio interview on Friday, Mr Salvini aligned himself squarely with Italy’s anti-vaccine movement, which has been fuelled by scepticism of established science and medicine. The movement was harshly critical of a law passed by the previous centre-left government requiring 10 mandatory vaccinations for school enrolment.
“We want to allow all kids to get into class, to go to school,” said Mr Salvini. “We will keep going because I believe that 10 mandatory vaccinations are useless, and in many cases dangerous if not harmful.”
Mr Salvini, the 45-year-old interior minister and vice-premier, has grabbed the Italian political spotlight since his new government — in alliance with the anti-establishment Five Star Movement — was sworn in on June 1 after a lengthy political stalemate.
Mr Salvini has developed a habit of daily, if not hourly, bombastic interventions that are challenging mainstream Italian policy and setting the political agenda. Mr Salvini’s comments on vaccinations come after a week in which he called for a “census” of Italy’s Roma population to identify anyone who should be deported, threatened to remove a police escort protecting Roberto Saviano, the anti-mafia author, and launched a barrage of attacks on non-governmental organisation rescue ships saving migrants in the Mediterranean Sea.
Mr Salvini’s attack on vaccines is notable because it goes well beyond his ministerial remit, as well as the “contract” setting out the terms of the League’s alliance in government with Five Star.
 
 
New York Times
http://www.nytimes.com/
Accessed 23 Jun 2018
Dr. Adel Mahmoud, 76, Dies; Credited With Major Vaccines
19 June 2018
Dr. Adel Mahmoud, an infectious-disease expert who played a vital role in the development of lifesaving vaccines, died on June 11 in Manhattan. He was 76. His death, at Mount Sinai St. Luke’s Hospital, was caused by a brain hemorrhage, his wife, Dr. Sally Hodder, said. As president of Merck Vaccines from 1998 until 2006, Dr. Mahmoud oversaw the creation and marketing of several vaccines that brought major advances in public health. One prevents rotavirus infection, a potentially fatal cause of diarrhea in babies. Another protects against human papillomavirus (HPV), which causes cancers of the cervix, anus, genitals and middle of the throat…

Washington Post
http://www.washingtonpost.com/
Accessed 23 Jun 2018
Kids in these U.S. hot spots at higher risk because parents opt out of vaccinations
Lena H. Sun · National/health-science · Jun 20, 2018

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_16 Jun 2018

– 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.

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

Milestones :: Perspectives

::::::

Ebola/EVD
 
At one-month mark in Ebola outbreak, the focus shifts to remote areas
WHO Statement,  Geneva
9 June 2018
[Editor’s text bolding]
One month into the response to an Ebola outbreak in the Democratic Republic of the Congo, the focus has moved from urban areas to some of the most remote places on earth.
The shift comes after a series of unprecedented actions that have led to cautious optimism about the effectiveness of the response.
A series of firsts
On 9 May, the day after country declared an outbreak of Ebola virus disease in Bikoro, the first WHO and Ministry of Health response team arrived in the provincial capital Mbandaka to begin setting up the specialized cold chain needed to store a vaccine.
By 11 May, teams had started to trace contacts of all active cases and WHO partners were setting up treatment centres in Bikoro. The next day, an air bridge was established to Bikoro and a mobile lab deployed to speed up testing for infection.
And then, just 6 days after the alert, the first batch of more than 4000 doses of vaccine was on its way from Geneva to Kinshasa. This marked the first time vaccines were available so early in a response.
Ring vaccination of contacts began on 21 May.
   On 4 June, an ethics committee in the country approved the use of 5 investigational therapeutics under the framework of compassionate use, following recommendations from a group of experts convened by WHO. This is the first time such treatments were available in the midst of a response.
“It’s far too early to declare victory, but the signals are positive and we are cautiously optimistic,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “We have new weapons and together with the government and our partners, we have acted with urgency to save lives. We will remain vigilant until this outbreak is over.”
As of 7 June, there were a total of 59 confirmed, probable and suspected Ebola cases, of which 27 people had died.  A new case was confirmed on 6 June…

Ebola response – building trust and engaging with affected communities
13 June 2018 – The following resources can be used to guide RCCE work which is central to stopping the outbreak and preventing its further amplification. Unlike other areas of response, RCCE draws heavily on volunteers, frontline personnel and on people without prior training in this area. As such, these resources provide basic background information, scopes the socio-economic and cultural aspects, and provides the latest evidence-based advice and approaches.
:: Risk communication and community engagement considerations for Ebola outbreak in DRC
:: ePROTECT occupational health and safety briefing
:: Ebola: Knowledge resources for responders

Ebola virus disease – Operational readiness and preparedness in nine countries neighbouring the Democratic Republic of the Congo
11 June 2018
Following the notification of an Ebola virus disease (EVD) outbreak in Equateur Province in the Democratic Republic of the Congo on 5 May 2018, WHO conducted a formal rapid risk assessment which determined that the public risk is high at the regional level.

On the basis of the rapid risk assessment, the WHO Regional Office for Africa identified nine countries neighbouring the Democratic Republic of the Congo to support them with preparedness and readiness activities: Angola, Burundi, Central African Republic, Republic of Congo, Rwanda, South Sudan, Tanzania, Uganda and Zambia. During the past month, WHO deployed teams of experts known as Preparation Support Teams (PST) to eight of the countries. The aim of these missions was to assess countries’ readiness using the WHO standardized checklist, and to provide technical support to countries to develop and initiate national contingency plans in collaboration with partners.

Risk in the nine neighbouring countries
There is a significant risk of spread of the ongoing EVD outbreak in the Democratic Republic of the Congo to neighbouring countries because of the geographic proximity, high volume of movement of people and goods across borders and along the Congo River, insufficient national capacities to prevent, detect and respond to EVD cases, and other factors which may enable transmission. The nine neighbouring countries were categorized into three priority levels based on their capacity to manage EVD and viral haemorrhagic fever (VHF) outbreaks and proximity to the affected areas (Figure 1).

The nine countries were categorized as follows, with priority 1 being the highest:
:: Priority 1: Central Africa Republic and Republic of Congo due to their proximity to the current event. These two countries share borders with the epicentre of the outbreak in Equateur Province and there is continuous population movement through the porous land borders and by the Congo and Oubangui rivers.
:: Priority 2: Angola, Burundi, Rwanda, South Sudan, Tanzania and Zambia which neighbour the Democratic Republic of the Congo but are not directly linked with Equateur Province.
:: Priority 3: Uganda because although it borders the Democratic Republic of the Congo, Uganda has regularly demonstrated the capacity to respond to recent previous VHF outbreaks…

Milestones :: Perspectives

Adel Mahmoud, global health leader and Princeton faculty member, dies at 76

Princeton University – The Office of Communications

June 13, 2018
[Excerpts]
Dr. Adel Mahmoud, a pioneer in the treatment and prevention of infectious diseases around the world, died Monday, June 11, in New York City. He was 76. The cause was a brain hemorrhage…

…In 1998, Mahmoud was recruited to serve as president of Merck Vaccines, a position he held until 2006. During his tenure at Merck, Mahmoud played a pivotal role in the development and commercialization of new vaccines to help prevent severe gastroenteritis, human papillomavirus (HPV) and shingles, as well as the quadrivalent formulation of measles-mumps-rubella-varicella vaccine. As of 2017, more than 500 million doses of these four vaccines have been distributed globally, according to the company.

“Adel was as beloved as he was accomplished, said Ken Frazier, Merck’s chairman and CEO. “He leaves an enduring legacy of protecting the health of infants, adolescents and adults around the world. Few physician-scientists have had the global public health impact that Adel Mahmoud had.”

Mahmoud frequently provided scientific advice to the World Health Organization, the National Institutes of Health, the Centers for Disease Control, the National Academies, the Rockefeller Foundation, and universities and research institutions around the world. He served as president of the International Society of Infectious Diseases from 1990-92 and on boards of directors at GAVI, the International AIDS Vaccine Initiative, International Vaccine Institute and several companies in the private sector…

“Adel was always one of the very first people to whom we turned when we needed sage advice about difficult policy issues,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “His judgment was flawless.”

…Mahmoud began his Princeton career in 2007 as a senior policy analyst at the Woodrow Wilson School of Public and International Affairs and transferred to the faculty in 2011 as a lecturer with the rank of professor in the Department of Molecular Biology and international affairs, Woodrow Wilson School. He also was an integral part of the Global Health Program.

Mahmoud is survived by his wife of 25 years, Dr. Sally Hodder, and a son, Jay Thornton, as well his siblings, Dr. Olfat Abdelfattah and Dr. Mahmoud Abdelfattah.

View or share comments on a blog intended to honor Mahmoud’s life and legacy.

Milestones :: Perspectives

The Charlevoix G7 Summit Communique

8-9 June 2018, Charlevoix, Canada

[Editor’s Note: The recent G& meeting issued its communique [full text at title link] which included one paragraph [of 28] focused on health as below. Editor’s text bolding]

1. We, the Leaders of the G7, have come together in Charlevoix, Quebec, Canada on June 8–9, 2018, guided by our shared values of freedom, democracy, the rule of law and respect for human rights and our commitment to promote a rules-based international order. As advanced economies and leading democracies, we share a fundamental commitment to investing in our citizens and meeting their needs and to responding to global challenges. We collectively affirm our strong determination to achieve a clean environment, clean air and clean water. We are resolved to work together in creating a healthy, prosperous, sustainable and fair future for all.

…6. To support growth and equal participation that benefits everyone, and ensure our citizens lead healthy and productive lives, we commit to supporting strong, sustainable health systems that promote access to quality and affordable healthcare and to bringing greater attention to mental health. We support efforts to promote and protect women’s and adolescents’ health and well-being through evidence-based healthcare and health information. We recognize the World Health Organization’s vital role in health emergencies, including through the Contingency Fund for Emergencies and the World Bank’s Pandemic Emergency Financing Facility, and emphasize their need for further development and continued and sustainable financing. We recommit to support our 76 partners to strengthen their implementation of the International Health Regulations, including through their development of costed national action plans and the use of diverse sources of financing and multi-stakeholder resources. We will prioritize and coordinate our global efforts to fight against antimicrobial resistance, in a “one health” approach. We will accelerate our efforts to end tuberculosis, and its resistant forms. We reconfirm our resolve to work with partners to eradicate polio and effectively manage the post-polio transition. We affirm our support for a successful replenishment of the Global Fund in 2019…

Emergencies

 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 12 June 2018 [GPEI]
:: Following unconfirmed reports on 8 June of suspected polio re-emergence in Venezuela, final laboratory testing has confirmed the cause of the paralysis is not wild poliovirus or vaccine-derived poliovirus. The full statement from the Global Polio Eradication Initiative may be read here.
:: World leaders at the G7 summit affirmed continued commitment to global polio eradication in the summit communique: “We reconfirm our resolve to work with partners to eradicate polio and effectively manage the post-polio transition”. [See Milestones above] for text]

Summary of newly-reported viruses this week:
Pakistan: One new wild poliovirus type 1 (WPV1) case reported.

Update on suspected polio case in Venezuela
Following unconfirmed reports on 8 June of suspected polio re-emergence in Venezuela, final laboratory testing has confirmed the cause of the paralysis is not wild poliovirus or vaccine-derived poliovirus.
15/06/2018 – Statement from the Global Polio Eradication Initiative
A 34-month old child had presented with symptoms of acute flaccid paralysis (AFP) on 29 April, from a community with low vaccination coverage in Orinoco delta, Delta Amacuro state.
A Sabin type 3 poliovirus was isolated from stool samples of the child. Isolation of Sabin type 3 poliovirus can be expected in children and communities immunized with bivalent oral polio vaccine, which contains attenuated (weakened) type 1 and type 3 Sabin strains.  Final laboratory analysis received today has confirmed that the AFP symptoms are not associated with wild or vaccine-derived poliovirus.
A number of conditions or infections can lead to AFP, poliovirus being just one of them.  As part of global polio surveillance efforts, every year more than 100 000 AFP cases are detected and investigated worldwide. Clinical evaluation of the child is underway to determine the cause of the paralysis. The most important point is that the child should be provided with appropriate care and support.
While wild and vaccine-derived polio have both been ruled out as the cause of this child’s symptoms, this area of Venezuela is experiencing vaccination coverage gaps. It is critical that countries maintain high immunity to polio in all communities, and strong disease surveillance, to minimize the risk and consequences of any eventual poliovirus re-introduction or re-emergence.
The partners of the Global Polio Eradication Initiative (GPEI) – WHO, the US Centers for Disease Control and Prevention, Rotary International, UNICEF and the Bill & Melinda Gates Foundation – will continue to support national and local public health authorities in these efforts, together with the Pan American Health Organization…

::::::
::::::

WHO Grade 3 Emergencies  [to 16 Jun 2018]
Yemen 
:: WHO and partners working with national health authorities to contain disease outbreaks
13 June 2018 – Infectious disease outbreaks are a serious public health concern, posing a direct threat to families, especially children, in every home in Yemen. Emergency preparedness and response structures could mean the difference between life and death for many people. Through the quick mobilization of readily available teams, the number of people affected could be reduced and the spread of deadly diseases controlled.
In the midst of war and faced with a collapsing health system, WHO, national health authorities, along with local and international partners, have scaled-up their operations, through the establishment of rapid response teams (RRTs) in the fight against disease outbreaks. These teams are critical; investigating outbreaks and ensuring that prevention and control measures are rapidly executed to contain any infectious disease threat.
These multi-disciplinary teams comprise health care professionals each with a specific skillset, designed to rapidly detect and contain a potential outbreak before it has a chance to spiral out of control.
…The fight against cholera 
As Yemen faces what is now known as the world’s largest cholera outbreak, these dedicated RRTs ensure that laser-focus on early detection, or the early identification of suspected cholera cases, and the investigation of the source are top priorities. The national epidemiological surveillance programme and WHO utilized the already established electronic integrated disease early warning system (eIDEWS) to support the early detection of suspected cholera. eIDEWS was initiated in 2013 as a pilot in 4 governorates (Aden, lahj, Abyan and Taiz) with a total 98 selected sites.
The eIDEWS is a surveillance and data collection program designed to rapidly detect potential outbreaks and public health threats at the earliest possible stages. The program then generates an alert in order to facilitate timely interventions and prompt response to help prevent or reduce the spread of the disease. These findings influence the response plan at district level, using essential findings from rapid assessments to formulate an informed and effective outbreak response.
The fight against cholera also resulted in the request of national health authorities for a way in which they could increase the mobility of RRTs to reach otherwise inaccessible areas in order to investigate and respond to reported outbreaks. This resulted in the procurement and planned distribution of 1000 motorbikes in Yemen.
“With disease outbreaks threatening the lives of millions of Yemeni people, an effective response relies heavily on the ability of RRTs to rapidly detect and investigate potential outbreaks. Early detection leads to timely interventions that save lives,” said Dr Zagaria.
:: Weekly epidemiology bulletin, 28 May–3 June 2018

::::::
 
WHO Grade 2 Emergencies  [to 16 Jun 2018]
[Several emergency pages were not available at inquiry]

::::::
::::::
 
UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Yemen 
:: Yemen Humanitarian Update Covering 4 – 11 June 2018 | Issue 19
:: Yemen: Al Hudaydah Update Situation Report No. 1, 14 June 2018
HIGHLIGHTS/KEY PRIORITIES
…Heavy fighting in Al Hudaydah put hundreds of thousands of civilians at risk;
…Al Hudaydah port remains open and food is being offloaded from vessels;
…Humanitarian organizations continue to provide life-saving assistance to displaced and vulnerable people despite a deterioration in the security situation;

Syrian Arab Republic 
:: Syrian Arab Republic: Humanitarian situation update in Afrin District and for IDPs in surrounding communities (as of 15 June 2018)

::::::

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
:: OCHA Flash Update #4 Tropical Cyclone Sagar | 14 June 2018

WHO & Regional Offices [to 16 Jun 2018]

WHO certifies Paraguay malaria-free
11 June 2018
News Release
San José / Geneva
The World Health Organization (WHO) today certified Paraguay as having eliminated malaria, the first country in the Americas to be granted this status since Cuba in 1973…
In 2016, WHO identified Paraguay as one of 21 countries with the potential to eliminate malaria by 2020. Through the “E-2020 initiative,” WHO is supporting these countries as they scale up activities to become malaria-free. Other E-2020 countries in the Americas include Belize, Costa Rica, Ecuador, El Salvador, Mexico and Suriname…

::::::

Weekly Epidemiological Record, 15 June 2018, vol. 93, 24 (pp. 345–356)
:: Immunization and Vaccine-related Implementation Research Advisory Committee (IVIR-AC): executive summary, 6–8 March 2018, Chamonix, France
Monthly report on dracunculiasis cases, January-April 2018
 
::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
Selected Featured News
:: Measles outbreak confirmed in northern Sierra Leone  14 June 2018
:: Yobe declares end of cholera, commends WHO’s leadership and coordination   13 June 2018
:: Scale-up measures to reduce adverse events and increase immunization uptake in Nigeria
13 June 2018
:: Returning home after surviving Ebola in the Democratic Republic of the Congo  13 June 2018
:: The Central African Republic prepares for Ebola response  12 June 2018

WHO Region of the Americas PAHO
:: Laboratory tests rule out the presence of wild and vaccine-derived poliovirus in the case of acute flaccid paralysis in Venezuela (06/15/2018)
:: CDB and PAHO sign agreement to support mental health in aftermath of natural disasters (06/13/2018)
:: Voluntary blood donation must be improved to ensure better patient outcomes (06/12/2018)
:: WHO certifies Paraguay malaria-free (06/10/2018)

 
WHO European Region EURO
:: Policy dialogue on implementing 2030 Agenda held during Regional Director’s visit to Romania 08-06-2018
:: New report reveals need for more humane, personalized approach in European Region’s long-term institutions for adults with intellectual and psychosocial disabilities 06-06-2018
:: Protect our environment, protect our health: World Environment Day 2018 05-06-2018

WHO Eastern Mediterranean Region EMRO
:: World Elder Abuse Awareness Day: alarmingly high rates of abuse in residential facilities 14-06-2018
:: European Working Group on Health in Climate Change supports countries in implementing key commitments 14-06-2018
:: 2018 FIFA World Cup: protect your health and score! 13-06-2018
:: Health payments are pushing people into poverty, even in high-income countries 12-06-2018

CDC/ACIP [to 16 Jun 2018]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

Register for upcoming June ACIP meeting
June 20-21, 2018
Deadline for registration:
Non-US Citizens: May 16, 2018
US Citizens: June 11, 2018
Registration is NOT required to watch the live meeting webcast or to listen via telephone.

Announcements

EDCTP    [to 16 Jun 2018]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
14 June 2018
EDCTP holds ‘trainer-of-trainers’ workshop on GCP-GCLP in Johannesburg, South Africa
The EDCTP Africa Office organised a workshop on Good Clinical Practice/Good Clinical Laboratory Practice in Johannesburg, South Africa, from 12-14 June 2018. Participants of 26 EDCTP-funded projects – including from the four EDCTP-funded regional Networks of Excellence…
 
 
European Vaccine Initiative  [to 16 Jun 2018]
http://www.euvaccine.eu/news-events
14 June 2018
PREV_PKDL Kick-off meeting

14 June 2018
SEmalvac2 & SEmalvac Annual Meeting 2018
 
 
FDA [to 16 Jun 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
June 12, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
 
 
Fondation Merieux  [to 16 Jun 2018]
http://www.fondation-merieux.org/
June 11, 2018
The Mérieux Foundation is deeply saddened by the loss of Professor Ogobara Doumbo, who passed away June 9th. Our thoughts are with his family and loved ones.
 
 
Human Vaccines Project   [to 16 Jun 2018]
http://www.humanvaccinesproject.org/media/press-releases/
Public Release: 11-Jun-2018
Human Vaccines Project announces new partnership with Telethon Kids Institute in Australia
NEW YORK, JUNE 11, 2018 – The Human Vaccines Project, a nonprofit public-private partnership focused on decoding the immune system to improve human health, today announced its first international scientific hub through a partnership with Telethon Kids Institute. Based in Perth, Western Australia, Telethon Kids Institute is recognized as a world leader in addressing the health of pediatric and indigenous populations.
Telethon Kids brings extensive and complementary scientific capacity to the Project. As one of Australia’s leading systems biology centers, with a team of almost 600 dedicated researchers and support staff, the organization is focused on discovering how and why childhood diseases develop, and aims to prevent and cure them through better therapies and interventions. Telethon Kids also engages with global researchers in low-resource settings including extensive collaboration with researchers in Papua New Guinea.
“Telethon Kids is a rapidly growing research institute in Australia that brings exceptional expertise to the Human Vaccines Project,” said Wayne Koff, PhD, president and CEO of the Human Vaccines Project. “The Institute’s knowledge in pediatrics and indigenous populations will enhance our efforts toward better vaccines and immunotherapies, as well as our work towards a universal flu vaccine.”…
 
 
IAVI  [to 16 Jun 2018]
https://www.iavi.org/
June 11, 2018
IAVI Mourns the Passing of Dr. Adel A. F. Mahmoud, Vaccine Champion and Public Health Visionary
Adel A. F. Mahmoud, MD, PhD, was a member of the IAVI Board of Directors from 2012.  He was an important advocate for a global focus on vaccine development and equitable access, including the importance of advancing HIV R&D.
IAVI is deeply saddened by the recent death of Adel A. F. Mahmoud, MD, PhD, a highly respected physician, scientist, professor, IAVI board member, and cherished friend. Most recently, he had a joint appointment at Princeton University as Professor in the Woodrow Wilson School and the Department of Molecular Biology. He has served as a valued and dedicated member of the IAVI Board of Directors from 2012.
“Adel was a unique force of nature and a tireless champion of science, education, and public health,” said Dr. Mark Feinberg, MD, PhD, IAVI President and CEO. “He is remembered by all whose lives he touched as a warm, vibrant, generous, and compassionate physician scientist who sought to eradicate childhood illnesses and infectious diseases through the development of new vaccines. Adel was also an important advocate for a global focus on vaccine development and equitable access, including the importance of advancing HIV R&D. His work has contributed to saving countless lives around the world. For those of us who were fortunate to have Adel as a friend, we know how much joy and positive energy he shared with us and how much we will miss his very special presence.” …
 
 
IFFIm
http://www.iffim.org/library/news/press-releases/
04 June 2018
Bertrand de Mazières joins IFFIm Board
Director General for Finance at the European Investment Bank brings IFFIm over three decades of international finance experience.

IVAC  [to 16 Jun 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
June 2018
Press Release: 1.45 million children’s lives saved by Hib and pneumococcal vaccines since 2000
Researchers estimate that during 2000-2015 pneumococcal conjugate vaccine prevented a total of about 250,000 child deaths—mostly after 2010—while Hib vaccines prevented 1.2 million child deaths.
 
 
MSF/Médecins Sans Frontières  [to 16 Jun 2018]
http://www.msf.org/en/updates
11 June 2018
Jordan: Lack of patients forces closure of Ramtha surgical project
Amman – After more than four years of emergency lifesaving activities in which over 2,700 war-wounded Syrians underwent medical treatment, Médecins Sans Frontières (MSF) has taken the difficult decision to close the Ramtha surgical project in northern Jordan. The decision came in light of the sharp decrease in the number of wounded Syrians referred from southern Syria to Ramtha hospital since a de-escalation zone was established in July 2017.
 
 
NIH  [to 16 Jun 2018]
http://www.nih.gov/news-events/news-releases
June 14, 2018
Early-stage Respiratory Syncytial Virus vaccine trial begins
— Phase 1 study will enroll a small group of healthy adult volunteers.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched a clinical trial of an investigational vaccine designed to protect against respiratory syncytial virus (RSV). The Phase 1 study will enroll a small group of healthy adult volunteers to examine the safety of an experimental intranasal vaccine and its ability to induce an immune response. The study is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched a clinical trial of an investigational vaccine designed to protect against respiratory syncytial virus (RSV). The Phase 1 study will enroll a small group of healthy adult volunteers to examine the safety of an experimental intranasal vaccine and its ability to induce an immune response. The study is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs)…

June 13, 2018
New trans-NIH consortium aims to advance pediatric research on a global level
— Nearly all of the 27 NIH institutes and centers fund some aspects of child health research.
The National Institutes of Health has formed the Trans-NIH Pediatric Research Consortium to coordinate pediatric research programs across its institutes and centers. Nearly all of the 27 NIH institutes and centers fund some aspects of child health research. In fiscal year 2017, this support totaled more than $4 billion. The new consortium aims to harmonize these activities, explore gaps and opportunities in the overall pediatric research portfolio, and set priorities.
“NIH-funded research has resulted in tremendous advances against diseases and conditions that affect child health and wellbeing, including asthma, cancer, autism, obesity, and intellectual and developmental disabilities,” said Diana W. Bianchi, M.D., director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the lead NIH institute for the consortium. “This consortium aims to capitalize on this momentum by enhancing crosstalk between scientific disciplines to address the wide range of health conditions experienced by children in this country and around the world.”
The new consortium will be led by the NICHD Director. In addition to project-based interactions, the full consortium will meet several times a year to discuss scientific opportunities and potential new areas of collaboration, including efforts to enhance training for the next generation of pediatricians.
 
 
UNAIDS [to 16 Jun 2018]
http://www.unaids.org/en
Feature story
South Sudan: raising the profile of HIV in humanitarian contexts
15 June 2018
In South Sudan, 7 million people are in need of humanitarian assistance and 5 million people need access to health services, including HIV prevention and treatment services. In this context, AIDS does not stand in isolation; rather, it is an entry point for social transformation. This was the message of Michel Sidibé, UNAIDS Executive Director, during his recent visit to the country.

Feature story
Celebrating the life of Calle Almedal
13 June 2018
UNAIDS is remembering the life and work of Calle Almedal, UNAIDS Senior Adviser on Partnerships with Civil Society and Faith-Based Organizations from 1997 to 2007. He was born in Sweden in 1945 and died on 7 June 2018 following a long battle with cancer.
“Calle Almedal was an outstanding professional, a passionate advocate and a personal friend and colleague. His legacy lives on in the lives of people of faith and of no faith in every corner of the world,” said Michel Sidibé, the Executive Director of UNAIDS.

Feature story
Luxembourg committed to accelerating the AIDS response in western and central Africa
11 June 2018
The Government of Luxembourg has announced that it will renewal its €1 million contribution to UNAIDS for the western and central Africa catch-up plan, with the funds focused on paediatric care and treatment and human rights. Launched in December 2016, the western and central Africa catch-up plan aims to ensure that 4.5 million people living with HIV in the region will have access to HIV treatment by 2020
 
 
Wellcome Trust  [to 16 Jun 2018]
https://wellcome.ac.uk/news
Published: 14 June 2018
How to make sense of the body’s billions of cells
An ambitious international project is attempting to create a ‘Google map’ of the human body by making three-dimensional maps of every human cell. It could transform our understanding of many diseases and how to treat them.

Published: 12 June 2018
Contagious Cities: people and pathogens, microbes and migration
On the centenary of the 1918 flu pandemic, Wellcome is exploring the relationship between cities and infections through Contagious Cities, an international cultural collaboration.
Michael Regnier, a science writer at Wellcome who has written about urbanisation and health (opens in a new tab), considers why cities are hotspots for contagions – and sources of solutions.
 
 
The Wistar Institute   [to 16 Jun 2018]
https://www.wistar.org/news/press-releases
Press Release  Jun. 13, 2018
Older Melanoma Patients Have Better Response to Immune Checkpoint Blockade Therapy
Age variations are related to different T cell populations present in the tumor immune environment of younger and older patients

::::::

Industry Watch   [to 16 Jun 2018]
:: FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for GARDASIL®9 in Women and Men Ages 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases
June 13, 2018 06:45 AM Eastern Daylight Time
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. The application is seeking approval for an expanded age indication for GARDASIL 9 for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine human papillomavirus (HPV) types covered by the vaccine. The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 6, 2018.
“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases,” said Dr. Alain Luxembourg, director, clinical research, Merck Research Laboratories. “We look forward to working with the FDA on the review of this application for GARDASIL 9, which, if approved, would enable more people to have access to the vaccine.”…

:: Themis Receives EMA PRIME Designation for Chikungunya Vaccine
June 11, 2018 05:00 AM Eastern Daylight Time
VIENNA–(BUSINESS WIRE)–Themis announced today that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its most advanced program in development, a vaccine to prevent chikungunya fever. The PRIME scheme is designed to provide enhanced regulatory support for the development of medicines that target an unmet medical need. Chikungunya is a mosquito-transmitted disease that can have debilitating long-term effects and has no current treatment or prevention options. Themis’ vaccine candidate has shown excellent safety and immune-response data in clinical testing to date. Final results of a large dose-confirmation Phase 2 trial are expected in mid-2018. Additional Phase 2 trials are underway, totaling over 600 study volunteers in the US, EU and Central America…

Journal Watch

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

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

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 16 Jun 2018)

Research article
Validity of parental recalls to estimate vaccination coverage: evidence from Tanzania
The estimates of vaccination coverage are measured from administrative data and from population based survey. While both card-based and recall data are collected through population survey, and the recall is when the card is missing, the preferred estimates remain of the card-based due to limited validity of parental recalls. As there is a concern of missing cards in poor settings, the evidence on validity of parental recalls is limited and varied across vaccine types, and therefore timely and needed. We validated the recalls against card-based data based on population survey in Tanzania.
Authors: Peter Binyaruka and Josephine Borghi
Citation: BMC Health Services Research 2018 18:440
Published on: 13 June 2018

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 16 Jun 2018)

Debate
Ethical issues related to human papillomavirus vaccination programs: an example from Bangladesh
Human Papilloma Virus (HPV) vaccine was introduced in Bangladesh through the arrangement of a demonstration project in Gazipur district in 2016, targeting grade five female students and non-school going girls (age range 10–12 years). HPV vaccination is expected to be eventually included in the nationwide immunization program if the demonstration project is successful. However, introduction and implementation of such a vaccination program raises various ethical concerns. This review paper illustrates a step by step assessment of the ethical concerns surrounding the HPV vaccination implementation in Bangladesh considering specific elements in administering and conducting the program as well as the intended results. Policy-makers, vaccine implementers, vaccine recipients, and an ethics specialist in Bangladesh were interviewed. Electronic database and websites have also been reviewed for relevant published literature and government statements.
Authors: Marium Salwa and Tarek Abdullah Al-Munim
Citation: BMC Medical Ethics 2018 19(Suppl 1):39
Published on: 15 June 2018

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 16 Jun 2018)

Research article
Perinatal health outcomes and care among asylum seekers and refugees: a systematic review of systematic reviews
Global migration is at an all-time high with implications for perinatal health. Migrant women, especially asylum seekers and refugees, represent a particularly vulnerable group. Understanding the impact on the…
Authors: Nicola Heslehurst, Heather Brown, Augustina Pemu, Hayley Coleman and Judith Rankin
Citation: BMC Medicine 2018 16:89
Published on: 12 June 2018

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 16 Jun 2018)

Research article
The role of timely initiation of antenatal care on protective dose tetanus toxoid immunization: the case of northern Ethiopia post natal mothers
Globally, tetanus toxoid protective dose immunization of the mothers is one of the strategies of maternal and neonatal tetanus prevention. Ethiopia has planned the national tetanus protection at birth coverage…
Authors: Muhabaw Shumye Mihret, Miteku Andualem Limenih and Temesgen Worku Gudayu
Citation: BMC Pregnancy and Childbirth 2018 18:235
Published on: 15 June 2018
 

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 16 Jun 2018)

Determinants of human papillomavirus vaccine attitudes: an interview of Wisconsin parents
Parental attitudes play a key role in their decisions to vaccinate adolescents against the human papillomavirus (HPV). Little is known, however, about the formative experiences that shape parents’ attitudes ab…
Authors: Kathrine L. Barnes, Jeffrey J. VanWormer, Shannon Stokley, Elizabeth R. Vickers, Huong Q. McLean, Edward A. Belongia and Casper G. Bendixsen
Citation: BMC Public Health 2018 18:746
Published on: 15 June 2018

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 16 Jun 2018)

Research article
Sub-national variation in measles vaccine coverage and outbreak risk: a case study from a 2010 outbreak in Malawi
Despite progress towards increasing global vaccination coverage, measles continues to be one of the leading, preventable causes of death among children worldwide. Whether and how to target sub-national areas f…
Authors: Avery Kundrick, Zhuojie Huang, Spencer Carran, Matthew Kagoli, Rebecca Freeman Grais, Northan Hurtado and Matthew Ferrari
Citation: BMC Public Health 2018 18:741
Published on: 15 June 2018

Clinical Trials
Volume: 15, Number: 3 (June 2018)
http://journals.sagepub.com/toc/ctja/15/3

Editorial
Expedited approval programs at the Food and Drug Administration
Colin B Begg, Susan S Ellenberg
First Published June 5, 2018; pp. 217–218

Clinical Trials
Volume: 15, Number: 3 (June 2018)
http://journals.sagepub.com/toc/ctja/15/3

Perspective
The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements
Joshua D Wallach, Joseph S Ross, Huseyin Naci
First Published June 5, 2018; pp. 219–229
Preview
The US Food and Drug Administration has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs is the regulatory flexibility, which allows for a customized approval approach that enables market authorization on the basis of less rigorous evidence, in exchange for requiring postmarket evidence generation. An increasing share of therapeutic agents approved by the Food and Drug Administration in recent years are associated with expedited programs. In this article, we provide an overview of the evidentiary standards required by the Food and Drug Administration’s expedited development and review programs, summarize the findings of the recent academic literature demonstrating some of the limitations of these programs, and outline potential opportunities to address these limitations. Recent evidence suggests that therapeutic agents in the Food and Drug Administration’s expedited programs are approved on the basis of fewer and smaller studies that may lack comparator groups and random allocation, and rather than focusing on clinical outcomes for study endpoints, rely instead on surrogate markers of disease. Once on the market, agents receiving expedited approvals are often quickly incorporated into clinical practice, and evidence generated in the postmarket period may not necessarily address the evidentiary limitations at the time of market entry. Furthermore, not all pathways require additional postmarket studies. Evidence suggests that drugs in expedited approval programs are associated with a greater likelihood that the Food and Drug Administration will take a safety action following market entry. There are several opportunities to improve the timeliness, information value, and validity of the pre- and postmarket studies of therapeutic agents receiving expedited approvals. When use of nonrandomized and uncontrolled studies cannot be avoided prior to market entry, randomized trials should be mandatory in the postmarket period, unless there are strong justifications for not carrying out such studies. In the premarket period, validity of the surrogate markers can be improved by more rigorously evaluating their correlation with patient-relevant clinical outcomes. Opportunities to reduce the duration, complexity, and cost of postmarket randomized trials should not compromise their validity and instead incorporate pragmatic “real-world” design elements. Despite recent enthusiasm for widely using real-world evidence, adaptive designs, and pragmatic trials in the regulatory setting, caution is warranted until large-scale empirical evaluations demonstrate their validity compared to more traditional trial designs.

Clinical Trials
Volume: 15, Number: 3 (June 2018)
http://journals.sagepub.com/toc/ctja/15/3

Commentaries
Expediting drug development for serious illness: Trade-offs between patient access and certainty
Janet Woodcock
First Published June 5, 2018; pp. 230–234

Clinical Trials
Volume: 15, Number: 3 (June 2018)
http://journals.sagepub.com/toc/ctja/15/3

Expedited and facilitated drug evaluations and evidence of benefit and risk: The cup is half-full
Robert M Califf
First Published June 5, 2018; pp. 235–239

Clinical Trials
Volume: 15, Number: 3 (June 2018)
http://journals.sagepub.com/toc/ctja/15/3

Access versus evidence: The regulators’ dilemma
Richard L Schilsky
First Published June 5, 2018; pp. 240–242

Clinical Trials
Volume: 15, Number: 3 (June 2018)
http://journals.sagepub.com/toc/ctja/15/3

Rejoinder
The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation
Joshua D Wallach, Joseph S Ross, Huseyin Naci
First Published June 5, 2018; pp. 243–246

Epidemiology and Infection
Volume 146 – Issue 8 – June 2018
https://www.cambridge.org/core/journals/epidemiology-and-infection/latest-issue

Measles- Short Paper
Can Flanders resist the measles outbreak? Assessing vaccination coverage in different age groups among Flemish residents
T. Braeckman, H. Theeten, M. Roelants, S. Blaizot, K. Hoppenbrouwers, K. Maertens, P. Van Damme, C. Vandermeulen
https://doi.org/10.1017/S0950268818000985
Published online: 02 May 2018, pp. 1043-1047

Humanitarian Exchange Magazine
Number 71  March 2018
https://odihpn.org/magazine/humanitarian-response-urban-areas/

Humanitarian response in urban areas
Humanitarian crises are increasingly affecting urban areas either directly, through civil conflict, hazards such as flooding or earthquakes, urban violence or outbreaks of disease, or indirectly, through hosting people fleeing these threats. The humanitarian sector has been slow to understand how the challenges and opportunities of working in urban spaces necessitate changes in how they operate. For agencies used to working in rural contexts, the dynamism of the city, with its reliance on markets, complex systems and intricate logistics, can be a daunting challenge. Huge, diverse and mobile populations complicate needs assessments, and close coordination with other, often unfamiliar, actors is necessary.

[Reviewed earlier]

International Journal of Community Medicine and Public Health
Vol 5, No 6 (2018) June 2018
http://www.ijcmph.com/index.php/ijcmph/issue/view/39

Original Research Articles
Measles vaccination coverage among children aged (12-23) months in Marawi locality – Northern state, Sudan – 2016
Wafaa Mubark Mohamed Osman
DOI: 10.18203/2394-6040.ijcmph20182144

International Journal of Infectious Diseases
June 2018 Volume 71, p1-124
https://www.ijidonline.com/issue/S1201-9712(18)X0005-8

Editorial
The preventable tragedy of diphtheria in the 21st century
L.H. Blumberg, M.A. Prieto, J.V. Diaz, M.J. Blanco, B. Valle, C. Pla, D.N. Durrheim
p122–123
Published in issue: June 2018

International Journal of Infectious Diseases
June 2018 Volume 71, p1-124
https://www.ijidonline.com/issue/S1201-9712(18)X0005-8

Perspective
Healthcare worker exposure to Middle East respiratory syndrome coronavirus (MERS-CoV): Revision of screening strategies urgently needed
Hala Amer, Abdulrahman S. Alqahtani, Faisal Alaklobi, Juhaina Altayeb, Ziad A. Memish
p113–116
Published online: April 9, 2018

Journal of Medical Internet Research
Vol 20, No 6 (2018): June
http://www.jmir.org/2018/6

Article
A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development
Robert D Furberg, Alexa M Ortiz, Rebecca R Moultrie, Melissa Raspa, Anne C Wheeler, Lauren A McCormack, Donald B Bailey Jr
JMIR Res Protoc 2018 (Jun 06); 7(6):e10525
ABSTRACT
Background: Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial. Objective: We describe the design and development process of a tablet-based decision support tool. Methods: Our development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles. Results: We used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice. Conclusions: The informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources. Trial Registration: ClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW)

The Lancet
Jun 16, 2018 Volume 391 Number 10138 p2389-2474  e21-e23
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31326-6/fulltext

Comment
Response to the Ebola virus disease outbreak in the Democratic Republic of the Congo
John N Nkengasong, Philip Onyebujoh

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 16 Jun 2018)

Policy Forum
The state of the antivaccine movement in the United States: A focused examination of nonmedical exemptions in states and counties
Jacqueline K. Olive, Peter J. Hotez, Ashish Damania, Melissa S. Nolan
| published 12 Jun 2018 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002578
Summary points
:: A social movement of public health vaccine opposition has been growing in the United States in recent years; subsequently, measles outbreaks have also increased.
:: Since 2009, the number of “philosophical-belief” vaccine nonmedical exemptions (NMEs) has risen in 12 of the 18 states that currently allow this policy: Arkansas (AR), Arizona (AZ), Idaho (ID), Maine (ME), Minnesota (MN), North Dakota (ND), Ohio (OH), Oklahoma (OK), Oregon (OR), Pennsylvania (PA), Texas (TX), and Utah (UT).
:: Several US “hotspot” metropolitan areas stand out for their very large numbers of NMEs. They include Seattle, WA, Spokane, WA, and Portland, OR in the Northwest; Phoenix, AZ, Salt Lake City, UT, Provo, UT, Houston, TX, Fort Worth, TX, Plano, TX, and Austin, TX in the Southwest; Troy, MI, Warren, MI, Detroit, MI, and Kansas City, MO in the Midwest; and Pittsburgh, PA in the Northeast. Additional smaller counties—especially in ID, WI, and UT—also stand out for their high exemption rates.
:: We analyzed the relationship between NME rates and actual vaccine coverage, and found an inverse association between NME rate and measles, mumps, and rubella (MMR) vaccine coverage of kindergarteners in these states (P = 0.03 by Spearman correlation), indicating that states with higher overall NME rates do in fact have lower MMR vaccine coverage (P = 0.007 by beta regression).
:: Our findings indicate that new foci of antivaccine activities are being established in major metropolitan areas, rendering select cities vulnerable for vaccination-preventable diseases. As noted by the recent experience in Anaheim, California, low vaccination rates resulted in a measles outbreak. In contrast, state closure of NMEs has resulted in an increase of MMR coverage.

PLoS One
http://www.plosone.org/
[Accessed 16 Jun 2018]

Research Article
Bias due to differential and non-differential disease- and exposure misclassification in studies of vaccine effectiveness
Tom De Smedt, Elizabeth Merrall, Denis Macina, Silvia Perez-Vilar, Nick Andrews, Kaatje Bollaerts
| published 15 Jun 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0199180

PLoS One
http://www.plosone.org/
[Accessed 16 Jun 2018]

Parental attitudes and perceptions associated with childhood vaccine exemptions in high-exemption schools
Heidi L. Pottinger, Elizabeth T. Jacobs, Steven D. Haenchen, Kacey C. Ernst
Research Article | published 14 Jun 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0198655

PLoS One
http://www.plosone.org/
[Accessed 16 Jun 2018]

Factors associated with uptake of influenza and pertussis vaccines among pregnant women in South Australia
Hassen Mohammed, Michelle Clarke, Ann Koehler, Maureen Watson, Helen Marshall
Research Article | published 14 Jun 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0197867

PLoS One
http://www.plosone.org/
[Accessed 16 Jun 2018]

The views of the general public on prioritising vaccination programmes against childhood diseases: A qualitative study
Gemma Lasseter, Hareth Al-Janabi, Caroline L. Trotter, Fran E. Carroll, Hannah Christensen
Research Article | published 13 Jun 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0197374

Science         
15 June 2018   Vol 360, Issue 6394
http://www.sciencemag.org/current.dtl

Editorial
HIV—No time for complacency
By Quarraisha Abdool Karim, Salim S. Abdool Karim
Science15 Jun 2018 : 1153
Summary
Today, the global HIV epidemic is widely viewed as triumph over tragedy. This stands in stark contrast to the first two decades of the epidemic, when AIDS was synonymous with suffering and death. But have we turned the tide on HIV sufficiently to warrant directing our attention and investments elsewhere?

Science Translational Medicine
13 June 2018   Vol 10, Issue 445
http://stm.sciencemag.org/

Focus
Curbing cholera
By Robert H. Hall
Science Translational Medicine13 Jun 2018 Restricted Access
Colonization of the gut by virulent Vibrio cholerae is suppressed by probiotic-like activity of a live cholera vaccine candidate and Lactococcus lactis in two animal models (Hubbard et al. and Mao et al., this issue).

Vaccine
Volume 36, Issue 27   Pages 3883-3992 (22 June 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/27

Regular papers
Feasibility of a pilot intervention to reduce pain and syncope during adolescent vaccination
Original research article
Pages 3937-3942
Michelle L. Henninger, Jennifer L. Kuntz, Alison J. Firemark, Alexandra M. Varga, … Allison L. Naleway

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

Health Equity
Volume 2 Issue 1  Jun 2018
Original Article
Barriers to HPV Vaccination Among Unvaccinated, Haitian American College Women
Pierre-Victor Dudith, Stephens Dionne P. , Omondi Angela , Clarke Rachel , Jean-Baptiste Naomie , and Madhivanan Purnima
Abstract
Background: Haitian women residing in the United States are disproportionately affected by cervical cancer. Human papillomavirus (HPV) vaccine has been licensed in the United States since 2006. Vaccination rates are less than optimal overall, and the rates are particularly low among young black women. We investigated barriers to HPV vaccination in a sample of Haitian American college women.
Methods: Thirty self-identified Haitian American women, aged 17−26 years, were recruited from a large university campus in southeastern United States (n=30). They completed in-depth face-to-face interviews. The research team analyzed the transcripts using thematic analysis.
Results: More than half of the participants (n=18) had not yet initiated the HPV vaccine series. Most of the unvaccinated participants stated that they had received a provider recommendation for the vaccine. Lack of provider recommendation, negative vaccine perception and attitudes, and side effect concerns constituted barriers to vaccination.
Conclusions: Haitian American college women at high risk of cervical cancer have cited several barriers to HPV vaccination, with the most prominent being lack of physician recommendation. Healthcare providers should continue recommending the vaccine to college women as many of them may not have received a recommendation. When recommending the HPV vaccine, discussions should be framed with the intent to positively influence HPV vaccine perceptions and ultimately vaccine attitudes.

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 16 Jun 2018
The Next Plague Is Coming. Is America Ready?
The epidemics of the early 21st century revealed a world unprepared, even as the risks continue to multiply. Much worse is coming.
Ed Yong   July/August 2018 Issue

Financial Times
http://www.ft.com/home/uk
Accessed 16 Jun 2018
Chinese medical tourism exacerbates shortage of HPV vaccine
15 June 2018
…Merck said it was “experiencing temporary supply constraints in some markets for our HPV vaccine”, citing Hong Kong as an area where supplies were insufficient to meet demand. “We currently expect that these constraints will continue throughout the coming year,” it added…But the shift in destinations appears to have created new shortages. Two hospitals in Malaysia and one in Singapore that are recommended in online forums for Chinese women told the FT that they had run out of stock of Gardasil.
 
 
New York Times
http://www.nytimes.com/
Accessed 16 Jun 2018
June 15
Opinion
Fighting the Nipah Virus
Infectious disease specialists say the global community must invest in further research about vaccination and treatment.

June 14
‘They’re at Risk:’ Congo’s Taxi Drivers Fear Ebola’s Spread
Propped against his motorcycle taxi outside a hospital in the city affected by Congo’s latest deadly Ebola outbreak, Jean Cedric waved a hand in the air, showing his fear about the risks of his job.

Africa
June 12
‘We Are Still at War’ With Ebola-WHO Chief
The head of the World Health Organisation (WHO) on Tuesday cautioned against declaring victory too early in Congo’s Ebola epidemic, despite encouraging signs that it may be brought under control.

June 12
Business Day
GSK Says Vaccine Business President to Leave by Year-End
GlaxoSmithKline Plc said the president of its vaccines business, Luc Debruyne, would leave the company at the end of the year.

STAT
https://www.statnews.com/
Accessed 16 Jun 2018
Seth Berkley: Do we keep waiting for the next pandemic or try to prevent it?
14 June 2018
…Global trends are steadily altering the global health landscape, making it easier for disease to spread. Despite the scientific and medical advances of the last century, climate change, population growth, human migration, urbanization, vaccine hesitancy, and antimicrobial resistance could start to make future outbreaks increasingly difficult to contain…

Washington Post
http://www.washingtonpost.com/
Accessed 16 Jun 2018
Kids in these U.S. hot spots at higher risk because parents opt out of vaccinations
Lena H. Sun · National/health-science · Jun 12, 2018

Think Tanks et al
 

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 16 Jun 2018
June 11, 2018
Global Health Development Value Frameworks: Are We Calculating Well and Wisely?
Alec Morton and Kalipso Chalkidou
The last several years have seen the development of many decision-support tools (“value frameworks”) for supporting policy and investment decisions. These tools make use of lots of numbers representing factors of undoubted importance in decision making, and they synthesise this information into a decision-relevant score or ranking or choice recommendation. Sometimes it is hard to trace how the numbers are combined; in other cases, although the relevant formulae are spelled out, it is hard to see why the numbers are combined in a particular way.

Council on Foreign Relations
http://www.cfr.org/
Accessed 16 Jun 2018
June 12, 2018
Public Health Threats and Pandemics
The Ebola Virus
Endemic to the African tropics, the Ebola virus has killed thousands in recent years, putting the World Health Organization and major donor countries in the limelight as they’ve grappled with how to …
Backgrounder by Claire Felter, and Danielle Renwick

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.

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