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

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary
 
 
Vaccine
Available online 7 September 2017
Review
Considerations for use of Ebola vaccine during an emergency response
JA Walldorf, EA Cloessner, TB Hyde, A MacNeil…
Abstract
Vaccination against Ebola virus disease is a tool that may limit disease transmission and deaths in future outbreaks, integrated within traditional Ebola outbreak prevention and control measures. Although a licensed Ebolavirus vaccine (EV) is not yet available, the 2014–2016 West African Ebola outbreak has accelerated EV clinical trials and given public health authorities in Guinea, Liberia, and Sierra Leone experience with implementation of emergency ring vaccination. As evidence supporting the use of EV during an outbreak response has become available, public health authorities in at-risk countries are considering how to integrate EV into future emergency Ebola responses and for prevention in high-risk groups, such as healthcare workers and frontline workers (HCW/FLWs), even before an EV is licensed. This review provides an overview of Ebola epidemiology, immunology, and evidence to inform regional and country-level decisions regarding EV delivery during an emergency response and to at-risk populations before a licensed vaccine is available and beyond. Countries or regions planning to use EV will need to assess factors such as the likelihood of a future Ebolavirus outbreak, the most likely species to cause an outbreak, the availability of a safe and effective EV (unlicensed or licensed) for the affected population, capacity to implement Ebola vaccination in conjunction with standard Ebola outbreak control measures, and availability of minimum essential resources and regulatory requirements to implement emergency Ebola vaccination. Potential emergency vaccination strategies for consideration include ring or geographically targeted community vaccination, HCW/FLW vaccination, and mass vaccination. The development of guidelines and protocols for Ebola vaccination will help ensure that activities are standardized, evidence-based, and well-coordinated with overall Ebola outbreak response efforts in the future.
 
 
Gut Microbes
Accepted author version posted online: 11 Sep 2017
Brief Report
Rotavirus Vaccine Response Correlates with the Infant Gut Microbiota Composition in Pakistan
V Harris, A Ali, S Fuentes, K Korpela, M Kazi, J Tate…
Abstract
Background
Rotavirus (RV) is the leading cause of diarrhea-related death in children worldwide, and ninety-five percent of rotavirus deaths occur in Africa and Asia. Rotavirus vaccines (RVV) can dramatically reduce RV deaths, but have low efficacy in low-income settings where they are most needed. The intestinal microbiome may contribute to this decreased RVV efficacy. This pilot study hypothesizes that infants’ intestinal microbiota composition correlates with RVV immune responses and that RVV responders have different gut microbiota as compared to non-responders.
Methods
We conducted a nested, matched case-control study comparing the pre-vaccination intestinal microbiota composition between 10 6-week old Pakistani RVV-responders, 10 6-week old Pakistani RVV non-responders, and 10 healthy Dutch infants.  RVV response was defined as an Immunoglobulin A of ≥20 IU/mL following Rotarix™(RV1) vaccination in an infant with a pre-vaccination IgA<20. Infants were matched in a 1:1 ratio using ranked variables: RV1 dosing schedule (6/10/14; 6/10; or 10/14 weeks), RV season, delivery mode, delivery place, breastfeeding practices, age and gender. Fecal microbiota analysis was performed using a highly reproducible phylogenetic microarray.
Results
RV1 response correlated with a higher relative abundance of bacteria belonging to Clostridium cluster XI and Proteobacteria, including bacteria related to Serratia and Escherichia coli. Remarkably, abundance of these Proteobacteria was also significantly higher in Dutch infants when compared to RV1-non-responders in Pakistan.
Conclusions
This small but carefully matched study showed the intestinal microbiota composition to correlate with RV1 seroconversion in Pakistan infants, identifying signatures shared with healthy Dutch infants.
Clinicaltrials.gov: NCT02220439

Health Behavior and Policy Review
2017  Volume 4, Number 5
Do Political and Religious Affiliations Impact HPV Vaccine Mandate Support?
BL Rosen, EL Thompson, KL Wilson, ML Smith –
Abstract
Objective: We attempted to identify characteristics of female college students supporting HPV vaccination mandates for school-aged youth and compare HPV vaccination mandate support by religious and political affiliations.
Methods: We analyzed data from 1034 college students. A multinomial logistic regression model was fitted using backwards stepwise entry.
Results: Students who self-identified as atheist and reported their parents supported HPV vaccination mandates were more likely to support HPV vaccination mandates. Those who believed mandates violated personal individual freedoms and parental rights were less likely to support mandates.
Conclusions: Interventions could focus on providing more education to groups more likely to oppose a mandate, thereby increasing support to protect school-aged youth from HPV.

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 16 September 2017
Bill Gates and Melinda Gates on Foreign Aid – The Atlantic
A new report from the Gates Foundation shows the devastating effects of a lapse in funding for global health.
Olga Khazan  Sep 13, 2017
 
Forbes
http://www.forbes.com/
Accessed 16 September 2017
Millions Could Die If Foreign Aid Is Cut, Gates Foundation Warns
13 September 2017

Dogs’ Immune Systems Are Much Like Ours And That’s A Boon To Cancer Research
Arlene Weintraub, Contributor
13 September 2017
The recent success of immune-boosting cancer treatments like checkpoint inhibitors and CAR-T cells has intensified the demand for more immunotherapy innovations. Pet dogs could help in the effort.

New York Times
http://www.nytimes.com/
Accessed 16 September 2017
Outbreak of Disease Carried by Mosquitoes Halts Blood Donation in Rome
Italian health officials have banned residents across half of Rome from donating blood because of an outbreak of the painful, mosquito-borne illness Chikungunya.
September 14, 2017 – By REUTERS ”

Study Prompts Call to Examine Flu Vaccine and Miscarriage
A puzzling study of U.S. pregnancies found that women who had miscarriages between 2010 and 2012 were more likely to have had back-to-back annual flu shots that included protection against swine flu.
September 13, 2017 – By THE ASSOCIATED PRESS

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 16 September 2017
Your Health
Less Than Half of U.S. Teens Complete HPV Vaccinations
By Sumathi Reddy
Sep. 11, 2017 10:56 am ET
New research finds 43% get the full set of shots, while over 80% get Tdap and meningitis vaccines at the same age.

Washington Post
http://www.washingtonpost.com/
Accessed 16 September 2017
Study prompts call to examine flu vaccine and miscarriage
Mike Stobbe | AP · National · Sep 13, 2017

Think Tanks et al

Think Tanks et al
 
Brookings
http://www.brookings.edu/
Accessed 16 September 2017
Report
Private Sector Investment in Global Health R&D
Spending Levels, Barriers, and Opportunities
Darrell M. West, John Villasenor, and Jake Schneider
In this report—the second published by the Project—authors Darrell West, John Villasenor, and Jake Schneider examine current private sector spending by pharmaceutical firms, venture capital funds, and impact investors in global health R&D. They analyze three types of R&D spending and, using data from a number of sources, calculate how much the private sector currently invests in each:
::Overall R&D focused on drugs, vaccines, and therapeutics in the developed and developing world: The authors calculate that there is an annual total of at least $159.9 billion spent on overall health R&D. This includes $156.7 billion from pharmaceutical companies and at least $3.2 billion from venture capital.
:: Global health R&D that emphasizes medical treatments in the developing world: An estimated annual total of $5.9 billion is spent on global health R&D focused on the developing world, with $5.6 billion coming from pharmaceutical firms and $225.8 million from venture capital companies.
:: Neglected disease R&D, which focuses on drugs, vaccines, and therapeutics for 35 specific illnesses that primarily impact populations in very poor nations: This category attracts the least private R&D money with a total of $471 million from pharmaceutical funders and $40 million from impact investors. (see full report)

Vaccines and Global Health: The Week in Review 9 September 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_9 September 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
 
 
PATH boosts leadership in developing and introducing urgently needed vaccines
PATH’s Center for Vaccine Innovation and Access attracts top global talent and additional $120 million investment from the Bill & Melinda Gates Foundation
Seattle, September 6, 2017—Building on decades of innovation in vaccine development and immunization, PATH announced today it has received a $120 million grant from the Bill & Melinda Gates Foundation to further strengthen its PATH Center for Vaccine Innovation and Access (CVIA), which works across every stage of vaccine research, development, and introduction for diseases in low-resource settings.

PATH also announced that several global experts in vaccine development and introduction have joined PATH CVIA to advance these critical vaccine efforts.

“We are excited to continue our long-standing partnership with the Bill & Melinda Gates Foundation to develop and introduce vaccines for the families and communities that need them most,” commented Steve Davis, president and CEO of PATH. “We are working on vaccines against over a dozen deadly diseases and partnering with governments and companies around the world to save lives and improve health through vaccine innovation and immunization.”

CVIA operates across the entire vaccine development and delivery spectrum—from preclinical research on novel candidates through pivotal clinical evaluations and, ultimately, innovative approaches for new vaccine introduction.

“From specific vaccine successes against Meningitis A and Japanese encephalitis to game-changing immunization supply chain technologies like the vaccine vial monitor, PATH has an impressive track record in saving lives through vaccine innovations,” commented Trevor Mundel, president of Global Health for the Bill & Melinda Gates Foundation. “We are delighted to support CVIA, a center of excellence for vaccine development and introduction.”…

PATH welcomed new experts in vaccine development and introduction who have joined the CVIA leadership team:
:: Fred Cassels, global head, Enteric and Diarrheal Diseases, served as chief of the Enteric and Hepatic Diseases Branch at the National Institutes of Health.
:: Bruce Innis, global head, Respiratory Infections and Maternal Immunization, brings his experience with GlaxoSmithKline, most recently as vice president and senior vaccine development leader for Influenza and Dengue Vaccines, and previous experience with the US Army as chief of the Department of Virus Diseases at the Walter Reed Army Institute of Research.
:: Harshvardhan (Hersh) Mehta, global head, Development (Chemistry, Manufacturing, and Controls), has over two decades of experience in senior roles for Merck, Sanofi, MedImmune, and Roche.
:: Karen Midthun, global head, Regulatory, served as director of the US Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research between 2009 and 2016 and served during the prior 16 years in progressively senior roles within FDA.

“It is an honor to welcome these world-renowned vaccine authorities to PATH,” commented David C. Kaslow, PATH vice president for Essential Medicines and global head of CVIA. “Together with PATH’s existing expertise, these new leaders will help PATH and our partners bring lifesaving and affordable vaccines to people living in the poorest communities around the world.”

PATH veterans taking on new roles to round out the CVIA leadership team include:
:: Deborah Atherly, global head, Policy, Access, & Introduction.
:: Ashley Birkett, global head, Malaria Vaccines.
:: Jorge Flores, global head, Clinical.
:: John Konz, global head, Integrated Portfolio & Financial Management.
:: Jessica Milman, managing director, CVIA.
:: Katya Spielberg, global head, Finance & Contract Management.

“We’re proud of our two decades of developing and delivering vaccines that are saving millions of lives,” added Steve Davis, president and CEO of PATH. “With this solid base of funding and this world-class team, PATH can do even more to combat age-old scourges and emerging threats.”

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NCI’s Douglas R. Lowy and John T. Schiller to receive 2017 Lasker Award
Wednesday, September 6, 2017
Two scientists at the National Cancer Institute (NCI) will receive the 2017 Lasker-DeBakey Clinical Medical Research Award for their significant research leading to the development of human papillomavirus (HPV) vaccines. The award is the country’s most prestigious biomedical research prize, and will be presented to John T. Schiller, Ph.D., of NCI’s Center for Cancer Research (CCR), and Douglas R. Lowy, M.D., also in CCR and acting director of NCI. NCI is part of the National Institutes of Health.

Dr. Lowy’s and Dr. Schiller’s collaborative work to understand and prevent HPV infection has led to the approval of three preventive HPV vaccines by the U.S. Food and Drug Administration.

“I’m incredibly proud of this much-deserved honor bestowed upon John and Doug for their foundational discoveries that led to the creation of HPV vaccines,” said NIH Director Francis S. Collins, M.D., Ph.D. “Thanks to their extraordinary efforts, we have the potential to eliminate cervical cancer and greatly reduce other HPV-associated cancers. This award reinforces the critical importance of basic research in the development of medical breakthroughs like the HPV vaccine.”

Efforts to develop these vaccines were spurred by an urgent public health need. Infection with certain types of HPV causes almost all cases of cervical cancer, the fourth most common cancer in women worldwide. More than 500,000 women around the world are diagnosed with cervical cancer each year, many of them at relatively young ages. More than 275,000 women die from the disease annually, and most of these deaths occur in developing regions of the world. Without successful interventions, the worldwide incidence and mortality from cervical cancer is projected to increase indefinitely. HPV infection also causes anal, vulvar, vaginal, penile, and oropharyngeal cancers.

While working to address the need to prevent HPV-caused cancers in the 1990s, a team led by Drs. Schiller and Lowy discovered that the proteins that form the outer shell of HPV could form virus-like particles (VLPs) that closely resemble the original virus but are not infectious. They found that these VLPs could trigger the immune system to produce high levels of protective antibodies that can neutralize the virus in a subsequent infection. The VLPs ultimately became the basis of the three current HPV vaccines: Gardasil, Gardasil 9, and Cervarix.

Drs. Lowy and Schiller say this breakthrough was possible because of earlier discoveries, and that it demonstrates the importance of long-term, publicly supported basic research.

“People have known since the 19th century that cervical cancer behaved as a sexually transmitted disease, but it wasn’t until the discoveries of Harald zur Hausen and his colleagues that HPV was found to be the cause. Development of the vaccines built upon decades of publicly supported research,” said Dr. Lowy. “We’re honored to be included with the other luminaries who have received this prestigious award.”

It is estimated that widespread uptake of current HPV vaccines could reduce the incidence and mortality of cervical cancer by more than two-thirds. Researchers are currently working to find ways to encourage uptake of the vaccines by lowering costs and simplifying the logistics of vaccination, especially in the developing world where most cervical cancers occur.

“This year’s Lasker Medical Research Awards illustrate the power of biomedical investigation to advance human health, whether scientists probe basic questions that reveal unforeseen truths or pursue goal-directed projects,” said Joseph L. Goldstein, M.D., chairman of the Department of Molecular Genetics at University of Texas Southwestern Medical Center, and chair of the Lasker Medical Research Awards Jury. “Douglas Lowy and John Schiller discovered that a single protein from the capsule of papillomaviruses can self-assemble into virus-like particles, paving the way for HPV vaccines that prevent cervical and other cancers.” …
 

Emergencies

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 6 September 2017 [GPEI]
:: Summary of newly-reported viruses this week: Pakistan: one new wild poliovirus type 1 (WPV1) case from Karachi (pre-notified last week) and four environmental WPV1-positive samples.

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WHO Grade 3 Emergencies  [to 9 September 2017]
Yemen
Weekly epidemiology bulletin, 28 August–3 September 2017
Highlights
Country and Governorate level (cumulative)
– The cumulative total from 27 April 2017 to 3 September 2017 is 612,009 suspected cases and 2,047 associated deaths (CFR 0.33). 25,883 suspected cases and 11 associated deaths were reported in W35.
– The national attack rate is 215 per 10,000. The five governorates with the highest cumulative attack rates per 10,000 remain Amran (540), Al Mahwit (504), Al Dhale’e (482), Abyan (388) and Hajjah (288).
– Children under 5 years old represent 24% of total suspected cases.
– In total, 11,414 rapid diagnostic tests (RDT) have been performed which represents 18.7% coverage. The coverage for culture is 16.9%.
Conclusions and actions taken
– WHO is on full alert and is following the evolution of the outbreak each day in close collaboration with local health authorities.
– Initial investigations began on 31 August. A key objective is to determine whether the numbers are accurate and whether the increase in suspected cases is, in fact, caused by cholera, another diarrhoeal disease, or another reason.
– Three teams of international medical experts and epidemiologists are conducting investigations in Aden, Al-Hudaydah and Ibb governorates.
– These teams are traveling out to the worst-affected districts in these three governorates, visiting local health authorities and health facilities to determine the reason for this sudden escalation in suspected cases.

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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. 
Syrian Arab Republic
:: 8 Sep 2017  Children caught up in the aftermath of violence in Syria and Iraq need immediate protection and assistance

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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.
Nigeria 
:: Nigeria – North-East Flash Update No. 2 – Cholera Outbreak, 6 September 2017

Ethiopia
:: Key Messages: Ethiopia humanitarian context , 8 September 2017
Third consecutive poor/failed rains exacerbate drought conditions in Ethiopia: Southern and eastern Ethiopia continue to battle the impact of drought caused by the Indian Ocean-related weather systems in 2016, exacerbated by below average spring rains this year – the third consecutive poor/failed rains in the southern and eastern regions. The drought conditions are compounded by disease outbreaks, large scale loss of livelihood assets and displacement.

The number of people requiring food assistance has increased by 3 million: At least 8.5 million people require relief food assistance in the second half of 2017, up from 5.6 million at the beginning of the year. In addition, 3.6 million moderately malnourished children and pregnant and lactating mothers will require supplementary feeding, at least 376,000 children are expected to become severely acutely malnourished and some 10.5 million people will not have regular access to safe drinking water until the end of 2017. Separately, some 4 million Public Works clients of the Productive Safety Net Program (PSNP) will require sustained assistance to the end of 2017. Although not formally included in the Mid-Year Review of Ethiopia’s 2017 Appeal, the financial requirements are estimated at US$300 million.

International partners scaling-up operations in support of the Government-led response: The UN and NGO partners have scaled-up response and further strengthened leadership and coordination functions in support of the Government-led response. With available, albeit quickly depleting resources, operational partners are pushing forward with the integrated, adaptable and scaled-up response in response to the rapidly changing humanitarian context and priorities.

Growing needs are outpacing the level of funding: with Government and donor contributions and commitments in 2016 and 2017, the initial projected requirement for Ethiopia’s humanitarian response was well funded. But an increase in those needing assistance following the Mid-Year Review means that there will at least be an outstanding gap of US$417.6 million for the rest of the year. Additional funding is urgently needed, especially at this critical juncture where any further delay in food assistance will have a domino effect on levels of malnutrition, and associated health complications particularly amongst children and the internally displaced.

The impact of back to back droughts underscores the need to prioritize development programming: The Government and its international partners are also investing in long-term development cooperation programs to reduce vulnerability to drought, including through accelerated urban development and industrial transformation. Ethiopia’s investments in basic services, including health, education and agriculture extension services, have helped make the poorest and most food insecure more resilient but much remains to be done. Increased joint planning between humanitarian and development systems is essential. Studies have shown that every dollar spent on resilience programming saves three dollars in humanitarian assistance.

:: 4 Sep 2017  Ethiopia Humanitarian Bulletin Issue 35 | 21 August – 3 September 2017

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Cholera
[See WHO Grade 3 Emergencies – Yemen above]
 
WHO issues updated cholera vaccines position paper
29 August 2017
In an updated position paper on cholera vaccines published in the August edition of the Weekly Epidemiological Record, WHO incorporates recent developments in the field of cholera and provides revised guidance on the target populations for immunization.
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Joint Press Release – Sierra Leone Ministry of Health and Sanitation, WHO, UNICEF, Gavi
Sierra Leone to begin cholera vaccination drive in disaster-affected areas
More than 1 million doses of Gavi-funded cholera vaccines heading to Sierra Leone after severe flooding and landslides
FREETOWN, 5 September 2017 – Half a million people in Sierra Leone will be able to access the life-saving cholera vaccine within weeks, the country’s Ministry of Health and Sanitation announced.

The vaccines will be received from the Gavi-funded global stockpile and will target areas particularly affected by August’s floods and deadly landslide, which resulted in over 500 confirmed deaths. Hundreds more people were reported missing in the wake of the disaster, according to the Office of National Security, while thousands were displaced from their homes.
“Cholera is a devastating disease which spreads quickly and kills fast, and risks can increase after severe flooding,” said Dr. Brima Kargbo, Chief Medical Officer at the Ministry of Health and Sanitation. “The oral cholera vaccine is an important tool to better protect the country and affected communities against the disease, which will ultimately save lives.”

Two rounds of vaccination are planned to run from September and will be delivered in 25 affected communities by the Government of Sierra Leone with support from Gavi Alliance, the World Health Organization (WHO), UNICEF, the UK Government and other health partners.

“The devastating floods and landslides which ravaged Sierra Leone throughout August have left the country dangerously vulnerable to water-borne disease outbreaks,” said Dr. Seth Berkley, CEO of Gavi Alliance. “Access to safe water and sanitation is limited, and the public health system, still recovering after the 2014 Ebola outbreak, is stretched. These lifesaving vaccines, alongside urgent support to improve safe water and sanitation, have the potential to prevent a cholera outbreak before it has the chance to bring more misery to a country that has already suffered enough.”

The decision to send cholera vaccines from the global stockpile was taken quickly on 31st August by the International Coordinating Group (ICG) for Vaccine Provision following the deployment of a WHO specialist to the country. The full quantity of the vaccine (1,036,300 doses for two rounds) is set to arrive in Freetown on 7th September through UNICEF’s global Supply Division.

WHO recommends that vaccination against cholera be considered in emergencies and other high-risk scenarios where there are increased threats of outbreaks, when combined with standard prevention and control measures for the disease. These measures include readiness to provide adequate testing and treatment, steps to ensure access to safe water and sanitation, and community mobilization to engage the public in preventing infection.

Sierra Leone’s last major cholera outbreak, in 2012, killed 392 people and infected more than 25,000 others.

Gavi, WHO, UNICEF and partners are working with the Ministry of Health and Sanitation to help plan and implement the campaign, which will make the vaccine available free-of-cost to disaster-affected populations, while supporting ongoing cholera prevention and preparedness.

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UNICEF  [to 9 September 2017]
https://www.unicef.org/media/
Selected News Releases
Growing concern for nearly 1.4 million internally displaced people living in cholera ‘hotspots’ as outbreak spreads in northeast Nigeria
MAIDUGURI/DAKAR/NEW YORK 7 September 2017 – There is growing concern for the health and wellbeing of 1.4 million displaced people, including 350,000 children under the age of five, living in cholera ‘hotspots’ in northeast Nigeria, UNICEF warned today.
 
The outbreak occurs as ongoing violence and military efforts against insurgents in the region have displaced more than 1.7 million people and left over 3.6 million without adequate access to basic water services.
An estimated 28 people have died from cholera, while 837 are suspected to have been infected with the disease, including at least 145 children under the age of five. The outbreak was first identified in the Muna Garage camp for the displaced in Maiduguri, the state capital of northeast Nigeria’s Borno state. The outbreak spread quickly to as many as six other locations across the state. UNICEF and partners have rapidly scaled up their response to the cholera outbreak, as heavy rains multiply the risk of disease and malnutrition for conflict affected children.
 
“Cholera is difficult for young children to withstand at any time, but becomes a crisis for survival when their resilience is already weakened by malnutrition, malaria and other waterborne diseases,” said UNICEF Deputy Representative in Nigeria, Pernille Ironside. “Cholera is one more threat amongst many that children in northeast Nigeria are battling today in order to survive.”
 
A cholera preparedness plan has been in place since before the rains began. Religious leaders, community heads and local volunteers have been mobilised to encourage good hygiene practices and help refer suspected cases to health facilities. Water
is chlorinated at access points in the camps and across host communities in an effort to curb the spread of disease as the rainy season continues.
 
Since the outbreak was confirmed there has been a closely coordinated water, sanitation and hygiene (WASH) and health rapid response, driven by the Borno State Government with support from WHO, UNICEF and international non-governmental organisations, including the setup of a cholera treatment centre at the Muna Garage Camp.
 
As the impact of the rains is felt, UNICEF has also scaled up its nutrition and child health programmes across the three northeast Nigerian states most affected by conflict. So far this year, UNICEF has treated over 110,000 children suffering from severe acute malnutrition, distributed nearly 120,000 mosquito nets and provided emergency primary health care services to over three million people in these states. The response continues despite increased security concerns, reduced access because of floods and a heavily damaged health system.
 
Even in the face of a deadly cholera outbreak, the WASH sector remains critically underfunded. To date, UNICEF has only received 49% of funding needed to provide two million people with access to clean water, one of the main interventions that can protect children from deadly waterborne diseases and offer some protection against the threat of malnutrition.

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Nigeria: MSF Scales Up Efforts to Contain Cholera Outbreak in Maiduguri
September 01, 2017
NEW YORK/MAIDUGURI, NIGERIA, SEPTEMBER 1, 2017—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) is scaling up treatment and prevention to curb the spread of cholera in Maiduguri in Borno State, Nigeria.

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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.
 
MERS-CoV [to 9 September 2017]
http://www.who.int/emergencies/mers-cov/en/
DONS
Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia
6 September 2017
Between 13 and 30 August 2017, the National IHR Focal Point of Saudi Arabia reported 12 additional cases of Middle East respiratory syndrome coronavirus (MERS-CoV), including one death and, and one death from a previously reported case…

Yellow Fever  [to 9 September 2017]
http://www.who.int/csr/disease/yellowfev/en/
30 August 2017
African Health Ministers pledge firm actions against yellow fever
Victoria Falls, Zimbabwe,:  African health ministers currently meeting for the 67th Session of the World Health Organization (WHO) Regional Committee in Zimbabwe have agreed on ten priority actions to guide countries to eliminate Yellow Fever (YF) epidemics by 2026…
Introducing the Framework for implementing the Global Strategy to Eliminate YF on behalf of the WHO Regional Director for Africa, Dr Matshidiso Moeti,  the Acting Director for the WHO Health Emergencies Programme, Dr Zabulon Yoti informed the ministers that low YF vaccination rates, limited vaccine supply and emergency stockpile, inadequate implementation of the International Health Regulations (IHR 2005), climate change, rapid urbanization are some of the factors that have put over 440 million people at risk. The World Health Organization estimates that in one of the worst outbreaks in 2013, there were about 170 000 severe YF cases in Africa that led to about 60 000 deaths. The massive pre-emptive vaccination of over 30 million people during the recent outbreak in Angola and DRC was a measure that averted an epidemic that could have been of similar magnitude to that of 2013.
“Yellow Fever is still a serious public health risk within and outside the Region. With a single dose of YF vaccine per person, elimination of YF epidemics is indeed a quick public health gain. Country ownership and leadership is critical to protect people at risk through preventive and routine vaccination,” he said…

Zika virus  [to 9 September 2017]
http://www.who.int/csr/disease/zika/en/
No new announcements identified.
 
Sanofi Statement on Zika Vaccine License
Sep 1, 2017
On August 17, 2017, Sanofi Pasteur was informed by The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services that they completed an assessment of all Zika-related projects they are funding and have decided to focus on a more limited set of goals and deliverables.

As a result of their review, Sanofi Pasteur has been notified of BARDA’s decision to “de-scope” its contract with Sanofi Pasteur to fund the manufacture and clinical development of an inactivated Zika vaccine and will limit its funding to a case definition and surveillance study as well as any activities required to advance our vaccine development to a point where development would be indefinitely paused but could be restarted if the epidemic re-emerges.
Consequently, Sanofi does not intend to continue development of, or seek a license from, the Walter Reed Army Institute of Research for the Zika vaccine candidate at this time.

We are proud of our contributions to the productive collaboration to date, which will result in significant contributions to science and to others who may continue pursuing licensure for an effective and safe Zika vaccine.

One of the ways Sanofi Pasteur will continue to contribute to the field of knowledge on Zika is by completing, with partial BARDA support, the ongoing case definition and surveillance study which will provide guidance on Zika epidemiology and diagnosis that can be applicable to any vaccine subsequently developed to prevent the disease.  The case-definition and surveillance study is currently being conducted in 4 countries—Colombia, Honduras, Mexico, and Puerto Rico—and we are looking to enroll 2,400 volunteers.

Given the evolving epidemiology of Zika, which has seen a profound reduction in the number of new Zika cases in the United States and around the world in 2017, as well as the results of the Phase I study, it was necessary to substantially extend our projected vaccine development timelines.  Therefore, we respect BARDA’s decision to re-purpose limited resources to meet their priorities.

In February 2016, Sanofi Pasteur urgently responded to the WHO’s declaration of a public-health emergency of international concern (PHEIC). In doing so, we assumed significant opportunity costs and delayed other internal pipeline priorities to lend our expertise to the Zika global public-health threat.  The epidemiology of the disease has changed significantly since that time, but we continue to believe that public-private partnerships are the right model to address these public health challenges and should continue to play a major role in response to emerging infectious diseases.

WHO & Regional Offices [to 9 September 2017]

WHO & Regional Offices [to 9 September 2017]

Seventieth session of WHO Regional Committee for South-East Asia
6 September 2017 — Dr Tedros outlined the priorities of WHO and several fast track initiatives during the transition period.

Highlights
Hurricane Irma: WHO taking measures to provide support
September 2017 – WHO country offices in the Caribbean are taking preventive measures to provide the necessary support to the authorities, and a team of infrastructure, engineering, and administrative specialists has been prepared to support the immediate assessment and response to the impact of countries located on the path of hurricane Irma.

A child’s search to treat kidney disease in Yemen
September 2017 – Accessing dialysis has always been tricky in Yemen, the poorest country in the Middle East. And now conflict has created additional challenges, with health facilities facing a shortage of supplies, and travel complicated by checkpoints and insecurity. In the midst of an economic crisis, it is exceptionally difficult for all patients to access the treatment they need.

Transforming primary care services in Kazakhstan
September 2017 – Kazakhstan is on track to achieve the global target of a 25% reduction in premature mortality from noncommunicable diseases by 2025. The main causes of years of life lost due to premature death in 2013 in Kazakhstan were ischaemic heart disease, cerebrovascular disease and self-harm.

::::::

Weekly Epidemiological Record, 8 September 2017, vol. 92, 36 (pp. 521–536)
:: Cholera, 2016
:: Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2017
:: The International Health Regulations (IHR) – 10 years of global public health security
 
::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Osun State distributes over two million Long Lasting Insecticide Treated Nets for malaria control. 08 September 2017
:: South Sudan launches the Expanded Special Project for Elimination of Neglected Tropical Diseases (ESPEN)
:: WHO Intensifies Efforts to Contain Cholera Outbreak in Borno State  08 September 2017
:: WHO deploys Polio personnel to forestall disease outbreaks in Benue state communities affected by floods.  07 September 2017
:: WHO and the Carter Center supports the cash reward programme for reporting of Guinea Worm Disease in Tonj State, South Sudan 07 September 2017
:: South Sudan’s malaria toll highlights disease burden in war-torn nation  06 September 2017
:: Looking out for Acute Watery Diarrhoea in Somali region: A day in the life of a World Health Organization (WHO) surveillance officer in Ethiopia’s Somali region  05 September 2017
:: Sierra Leone to begin cholera vaccination drive in disaster-affected areas  05 September 2017
:: African Health Ministers pledge firm actions against yellow fever  04 September 2017

WHO Region of the Americas PAHO
:: Measles and Rubella Initiative Champion Award presented to PAHO (09/07/2017)
 
WHO South-East Asia Region SEARO
:: Prepare well to rapidly detect, respond to vector-borne diseases: WHO
:: Ministry of Health Maldives gets WHO Excellence in Public Health Award

WHO European Region EURO
:: Breakthrough for men’s health: WHO and experts kick off development of strategy and report 08-09-2017
For the first time, WHO is undertaking a strategy entirely focused on the health and well-being of men and boys. A group of experts from a range of fields and disciplines related to men’s health came together on 5 September 2017 at UN City in Copenhagen, Denmark, to launch the development of the strategy for the WHO European Region.

:: European leaders set new roadmap to achieve 2030 Agenda and improve 900 million people’s health and well-being 07-09-2017
Health leaders gather at the annual meeting of the WHO Regional Committee for Europe. In Budapest, Hungary on 11–14 September 2017 they will take decisions on health priorities that will have an impact on the health and well-being of about 900 million people in the WHO European Region, including in the European Union, central and eastern Europe, the Caucasus and central Asia.

:: Towards tobacco-free generations: emerging threats for children in the Region 06-09-2017
Several Member States in the WHO European Region are moving towards becoming “tobacco-free”, which means having a smoking prevalence of 5% or less. To achieve this, countries must address a number of tobacco-related issues that specifically impact children, and work to protect children from the harmful effects of tobacco.

::L Ukraine: 20% reduction in smokers since 2010 04-09-2017
The results of the Global Adult Tobacco Survey (GATS) recently released in Ukraine reveal a 20% reduction in the number of smokers over the past 7 years. Following WHO recommendations, Ukraine has strengthened its anti-tobacco legislation resulting in this reduction in the proportion of the population who smoke.

:: The Ashgabat Statement: Europe commits to staying malaria free 04-09-2017
The WHO European Region is marking an important step on the road from malaria control to malaria elimination, and then on to maintaining malaria-free status, with the launch of The Ashgabat Statement: Preventing the re-establishment of malaria transmission in the WHO European Region. The Statement is being formally presented on 4 September in Moscow, Russian Federation.

WHO Eastern Mediterranean Region EMRO
:: Effective preparedness for hajj 2017 (1438 H) pays off: no major public health events reported
3 September 2017, Makkah – The World Health Organization (WHO) today concluded a successful mission to Saudi Arabia to support the Ministry of Health in ensuring a safe hajj season. No disease outbreak or public health event of concern was reported among the nearly 2.4 million pilgrims visiting the holy sites during this year’s hajj, in spite of an increased number of pilgrims performing hajj this year.
WHO’s mission to Saudi Arabia was conducted as part of a range of activities undertaken by the Organization to support countries in ensuring effective implementation of the core public health capacities required under the International Health Regulations (IHR 2005) to prevent, detect and rapidly respond to any public health threat before it becomes an event of international concern. These activities are also outlined in the Regional Director’s roadmap which details a set of strategic actions to guide WHO’s work with Member States for the next five year…

CDC/ACIP [to 9 September 2017]

CDC/ACIP [to 9 September 2017]
http://www.cdc.gov/media/index.html

MMWR News Synopsis for September 7, 2017
:: Update: Increase in Human Infections with Novel Avian Influenza A(H7N9) Viruses During the Fifth Epidemic and Pandemic Preparedness — China, October 1, 2016–August 18, 2017
Avian influenza A(H7N9) viruses remain a pandemic concern. The fifth annual epidemic of Asian Lineage Avian Influenza A(H7N9) Viruses in China is marked by extensive geographic spread in poultry and in humans. The number of human infections reported in the fifth epidemic is almost as many as were reported during the previous four epidemics combined. The increased number of human infections appears to be associated with wider geographic spread and higher prevalence of Asian H7N9 viruses among poultry rather than any increased incidence of poultry-to-human or human-to-human spread. Human infections with Asian H7N9 viruses from poultry are rare, and no efficient or sustained human-to-human transmission has been detected. Among all influenza viruses assessed using CDC’s Influenza Risk Assessment Tool, the Asian H7N9 virus is ranked as the influenza virus with the highest potential pandemic risk. Continued vigilance is important to identify changes in the virus that have epidemiologic implications, such as increased transmission from poultry to humans or transmission between humans.

Announcements

Announcements
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 9 September 2017]
http://cepi.net/
[Undated]
Call: Platform technologies to enable rapid vaccine development for epidemic prone infections
CEPI is pleased to announce its second funding opportunity for the development of vaccines against epidemic infectious diseases.
In this two-step call, CEPI asks for submission of proposals for vaccine platform technologies that enable rapid vaccine development, rapid scale up, and quick time to immunity for reactive use in outbreaks of novel or previously unrecognised viruses. Proposals can include new platforms with the potential for rapidly making a vaccine using materials generally regarded as safe (GRAS), or those compressing the time of an existing (proven) platform to make it more responsive in an unknown threat situation. During the proposed project period, we encourage developers to target the following timelines:
Target a 16-week timeframe from identification of antigen to product release for clinical trials
Target a 6-week timeframe from administration of first dose to achievement of clinical benefit (i.e. immune response likely to result in clinical benefit)
Produce 100,000 vaccine doses within 8 weeks to impact an emerging outbreak (i.e. from Go-decision to scale-up to production, fill, finish, and release)
Timeline
Deadline for submission of step 1 proposals: 4 p.m. CEST 17 October 2017
Call text for proposals on platform technology PDF FORMAT – 272KB Download

EDCTP    [to 9 September 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
No new digest content identified.

European Medicines Agency  [to 9 September 2017]
http://www.ema.europa.eu/ema/
04/09/2017
Reporting side effects of medicines
EMA launches survey to assess whether patients and doctors are aware of the arrangements for reporting of side effects …
 
FDA [to 9 September 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New in Biologics
Influenza Virus Vaccine for the 2017-2018 Season
Updated: 9/7/2017
 
Fondation Merieux  [to 9 September 2017]
http://www.fondation-merieux.org/
September 5, 2017, Bamako, Mali
First day of school for the BAMS training in medical applied biology
On 1 October 2007[?2017?], the first year of students – professionals of biological analysis, arrived at the Charles Mérieux Center for Infectious Disease in Bamako in order to follow the new qualified laboratory technicians training: BAMS.
The Mérieux Foundation knows that the improvement of the quality in public health needs the strengthening of capacities in medical biology: it has decided, in partnership with ESTBB, to create the BAMS training.
16 laboratory technicians selected among 85 candidates will follow until May 2008 theoretical and practical teaching in the fields of immunology, biochemistry, bacteriology, parasitology, virology and molecular biology. The teachers of these courses are Malian and French.
The technicians chosen for this first year of BAMS work in different national health centres of reference in Mali and Burkina Faso. The Ministry of Health in Mali accepted that the technicians follow the training because the health professionals were committed to return to work in their original laboratories in order to contribute to the quality of the public health.
 
Gavi [to 9 September 2017]
http://www.gavi.org/library/news/press-releases/
05 September 2017
Sierra Leone to begin cholera vaccination drive in disaster-affected areas
More than 1 million doses of Gavi-funded cholera vaccines heading to Sierra Leone after severe flooding and landslides.
[See Cholera above for more detail]
 
IVI   [to 9 September 2017]
http://www.ivi.int/
September 4, 2017
IVI Hosts 17th International Vaccinology Course in Seoul on September 4-8
:: Aeras Chief Medical Officer Dr. Ann Ginsberg delivers closing plenary speech on TB vaccine development; Korea University Prof. Woo-joo Kim to address Vaccine Preparedness and Response to Emerging Infectious Diseases
:: 112 participants from 19 countries including trainees participate in this year’s event hosted jointly by IVI, KOHI
:: 35 experts from international agencies, research institutions, universities, industry and non-profit organizations, including IVI, WHO and U.S. NIH serve as faculty members
 
MSF/Médecins Sans Frontières  [to 9 September 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Nigeria: MSF Scales Up Efforts to Contain Cholera Outbreak in Maiduguri
September 01, 2017
NEW YORK/MAIDUGURI, NIGERIA, SEPTEMBER 1, 2017—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) is scaling up treatment and prevention to curb the spread of cholera in Maiduguri in Borno State, Nigeria.
 
NIH  [to 9 September 2017]
http://www.nih.gov/news-events/news-releases
September 7, 2017
NIH awards nearly $100 million for Autism Centers of Excellence program
— Program supports large research projects aimed at understanding and developing interventions for autism spectrum disorder

NCI’s Douglas R. Lowy and John T. Schiller to receive 2017 Lasker Award
September 6, 2017 — Scientists honored for their research leading to the development of HPV vaccines
[See Milestones above for more detail]

Zika virus selectively infects and kills glioblastoma cells in mice
September 5, 2017 — Researchers describe the impact of ZIKV on glioblastoma cells in human tissue samples and mice

Drug combination reduces risk of HIV infection among teen males
September 5, 2017 — NIH-funded study suggests PrEP therapy, approved for adults, is safe for youth.
 
PATH  [to 9 September 2017]
http://www.path.org/news/index.php
Press release | September 08, 2017
PATH and Walter Reed Army Institute of Research announce largest-ever controlled malaria infection study
Study in adult US volunteers to investigate which changes in the RTS,S malaria vaccine candidate regimen increase protection the most

Press release | September 06, 2017
PATH boosts leadership in developing and introducing urgently needed vaccines
PATH’s Center for Vaccine Innovation and Access attracts top global talent and additional $120 million investment from the Bill & Melinda Gates Foundation
[See Milestones above for more detail]
 
 
Wellcome Trust  [to 9 September 2017]
https://wellcome.ac.uk/news
News / Published: 4 September 2017
Wellcome joins £52 million global drive on antibiotic resistance
Wellcome is committing up to £1 million as part of a £52 million (€56.5m) global pledge to tackle antibiotic resistance.
Latest funding for the Global Antibiotic Research and Development Partnership (opens in a new tab) (GARDP) was announced today by the German government.
Other countries and foundations pledging funds include the Netherlands, Switzerland, South Africa, Luxembourg and the UK government.
Jeremy Farrar, Wellcome’s Director, said: “We must all work together to address the deadly threat of drug-resistant infections, which already kill 700,000 people a year. Wellcome is delighted to work with Germany and other partners to ensure communities around the world are better protected against this and other serious health threats.”…
 
::::::
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 9 September 2017]
http://www.dcvmn.org/
25 September 2017 to 28 September 2017
DCVMN Annual General Meeting
Seoul / Korea

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

 
Ebola research agenda
Infectious Diseases Data Observatory (IDDO)
Help design a collaborative research agenda to inform and inspire analyses using data from the Ebola data sharing platform. You can contribute your ideas on research priorities which address knowledge gaps with new evidence to improve patient care and outbreak response.
Construction of the Ebola data sharing platform is currently under way with available clinical and laboratory data, and will later include epidemiological data.
We want to hear from you, the research, health and humanitarian communities, about what the priority research questions are. Please download our Ebola Data Sharing Platform: Draft Research Agenda for Public Consultation and contribute to the development of a research agenda which maximises the impact of available data.
 
Massive Ebola data site planned to combat outbreaks
Nature | News 04 September 2017
Amy Maxmen
An international partnership seeks African leadership to organize information about the disease.
More than 11,000 people died when Ebola tore through West Africa between 2014 and 2016, and yet clinicians still lack data that would enable them to reliably identify the disease when a person first walks into a clinic. To fill that gap and others before the next outbreak hits, researchers are developing a platform to organize and share Ebola data that have so far been scattered beyond reach.
The information system is coordinated by the Infectious Diseases Data Observatory (IDDO), an international research network based at the University of Oxford, UK, and is expected to launch by the end of the year. At a meeting to discuss Ebola on 7–9 September in Conakry, Guinea, the team heading the platform will seek input from West African scientists, health officials and advocacy groups.
“We are looking for West African leadership in this initiative,” says Laura Merson, associate director of the IDDO.
Africans must be involved in the platform’s creation so that they can not only use the existing data, but also improve their capacity to conduct research during future outbreaks, says John Amuasi, an infectious-diseases researcher at the Kumasi Centre for Collaborative Research in Tropical Medicine in Ghana and a member of the platform’s steering committee. A true partnership would also lessen the general public’s mistrust of scientists, he adds….

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

American Journal of Tropical Medicine and Hygiene – Volume 97, Issue 3, 2017

American Journal of Tropical Medicine and Hygiene
Volume 97, Issue 3, 2017
http://www.ajtmh.org/content/current

Editorials
The Fogarty International Center is Essential to Global Health Security
Author: John Edward Porter
https://doi.org/10.4269/ajtmh.17-0597

Let’s Eliminate Diseases, Not Institutes: The Case for the Fogarty International Center
Authors: Philip J. Rosenthal, Karen A. Goraleski, N. Regina Rabinovich and Patricia F. Walker
https://doi.org/10.4269/ajtmh.17-0601

Congressman John E. Fogarty: A Champion for Global Health
Author: Mary Fogarty McAndrew
https://doi.org/10.4269/ajtmh.17-0612

Advocating for the Fogarty International Center: An Unsung Hero for Global Health Research and Development
Author: Jamie Bay Nishi
https://doi.org/10.4269/ajtmh.17-0611

Classification and Visualization of Physical and Chemical Properties of Falsified Medicines with Handheld Raman Spectroscopy and X-Ray Computed Tomography

American Journal of Tropical Medicine and Hygiene
Volume 97, Issue 3, 2017
http://www.ajtmh.org/content/current

Articles
Classification and Visualization of Physical and Chemical Properties of Falsified Medicines with Handheld Raman Spectroscopy and X-Ray Computed Tomography
Authors: Tomoko Kakio, Naoko Yoshida, Susan Macha, Kazunobu Moriguchi, Takashi Hiroshima, Yukihiro Ikeda, Hirohito Tsuboi and Kazuko Kimura
https://doi.org/10.4269/ajtmh.16-0971
Analytical methods for the detection of substandard and falsified medical products (SFs) are important for public health and patient safety. Research to understand how the physical and chemical properties of SFs can be most effectively applied to distinguish the SFs from authentic products has not yet been investigated enough. Here, we investigated the usefulness of two analytical methods, handheld Raman spectroscopy (handheld Raman) and X-ray computed tomography (X-ray CT), for detecting SFs among oral solid antihypertensive pharmaceutical products containing candesartan cilexetil as an active pharmaceutical ingredient (API). X-ray CT visualized at least two different types of falsified tablets, one containing many cracks and voids and the other containing aggregates with high electron density, such as from the presence of the heavy elements. Generic products that purported to contain equivalent amounts of API to the authentic products were discriminated from the authentic products by the handheld Raman and the different physical structure on X-ray CT. Approach to investigate both the chemical and physical properties with handheld Raman and X-ray CT, respectively, promise the accurate discrimination of the SFs, even if their visual appearance is similar with authentic products. We present a decision tree for investigating the authenticity of samples purporting to be authentic commercial tablets. Our results indicate that the combination approach of visual observation, handheld Raman and X-ray CT is a powerful strategy for nondestructive discrimination of suspect samples.

Cost-effectiveness of human papillomavirus vaccination in Germany

BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 9 September 2017)

Research
Cost-effectiveness of human papillomavirus vaccination in Germany
Our model results suggest that routine HPV vaccination of 12-year-old girls with three doses is likely to be cost-effective in Germany. Due to the additional impact on genital warts, the quadrivalent vaccine appeared to be more cost-effective than the bivalent vaccine. A 2-dose schedule of the quadrivalent vaccine might even lead to cost savings when adopting a societal perspective. The cost-effectiveness of additional vaccination of boys was highly dependent on the coverage in girls.
Oliver Damm, Johannes Horn, Rafael T. Mikolajczyk, Mirjam E. E. Kretzschmar, Andreas M. Kaufmann, Yvonne Deleré, Bernhard Ultsch, Ole Wichmann, Alexander Krämer and Wolfgang Greiner
Published on: 4 September 2017

What do we know about the needs and challenges of health systems? A scoping review of the international literature

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 9 September 2017)

Research article
What do we know about the needs and challenges of health systems? A scoping review of the international literature
While there is an extensive literature on Health System (HS) strengthening and on the performance of specific HSs, there are few exhaustive syntheses of the challenges HSs are facing worldwide. This paper reports the findings of a scoping review aiming to classify the challenges of HSs investigated in the scientific literature. Specifically, it determines the kind of research conducted on HS challenges, where it was performed, in which health sectors and on which populations. It also identifies the types of challenge described the most and how they varied across countries.
Federico Roncarolo, Antoine Boivin, Jean-Louis Denis, Rejean Hébert and Pascale Lehoux
BMC Health Services Research 2017 17:636
Published on: 8 September 2017

Care-managers’ professional choices: ethical dilemmas and conflicting expectations

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 9 September 2017)

Research article
Care-managers’ professional choices: ethical dilemmas and conflicting expectations
Care-managers are responsible for the public administration of individual healthcare decisions and decide on the volume and content of community healthcare services given to a population.
Siri Tønnessen, Gøril Ursin and Berit Støre Brinchmann
BMC Health Services Research 2017 17:630
Published on: 7 September 2017

Cost-effectiveness analysis of quadrivalent seasonal influenza vaccines in England

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 9 September 2017)

Research article
Cost-effectiveness analysis of quadrivalent seasonal influenza vaccines in England
The cost-effectiveness of quadrivalent vaccine programmes is an open question. The original analysis that supported the paediatric programme only considered a trivalent live attenuated vaccine (LAIV). The cost-effectiveness of the QIIV to other patients has not been established. We sought to estimate the cost-effectiveness of these programmes, establishing a maximum incremental total cost per dose of quadrivalent vaccines over trivalent vaccines.
Dominic Thorrington, Edwin van Leeuwen, Mary Ramsay, Richard Pebody and Marc Baguelin
Published on: 8 September 2017

An assessment of healthcare professionals’ knowledge about and attitude towards influenza vaccination in Freetown Sierra Leone: a cross-sectional study

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 9 September 2017)

Research article
An assessment of healthcare professionals’ knowledge about and attitude towards influenza vaccination in Freetown Sierra Leone: a cross-sectional study
Vaccinating healthcare professionals against influenza is considered an effective infection control measure. However, there is a low uptake of influenza vaccine among healthcare professionals around the globe….
Peter Bai James, Inayat Ur Rehman, Abudulai Jawo Bah, Michael Lahai, Christine Princess Cole and Tahir Mehmood Khan
BMC Public Health 2017 17:692
Published on: 5 September 2017

International tuberculosis research collaborations within Asia

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 9 September 2017)

Original article   Open Access
International tuberculosis research collaborations within Asia
James S. Molton, Shweta Singh, Ling Jun Chen and Nicholas I. Paton
BMC Research Notes 2017 10:462
Published on: 7 September 2017
Abstract
Background
Asia bears more than half the global tuberculosis (TB) burden. Economic development in the region has increased available funding for biomedical research and opportunity for collaboration. We explored the extent of international tuberculosis research collaborations between institutions within Asia.
Methods
We conducted a Pubmed search for all articles with tuberculosis in the title published during a 12 month period with at least one author affiliation listed in Asia, then identified international collaborations from institution websites and internet searches.
Results
We identified 99 international collaborations involving an institution within Asia, of which only 8 (8.1%) were collaborations between Asian institutions. The remainder were with institutions outside of Asia.
Conclusions
The paucity of intra-Asian international research collaboration represents a lost opportunity to optimise regional research funding, capacity building and the development of an Asia-relevant TB research agenda.

Dengue vaccines: implications for dengue control

Current Opinion in Infectious Diseases
October 2017 – Volume 30 – Issue 5
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx
TROPICAL AND TRAVEL-ASSOCIATED DISEASES

Edited by Joseph M. Vinetz and Yukari C. Manabe
Dengue vaccines: implications for dengue control
Robinson, Matthew L.; Durbin, Anna P.
Current Opinion in Infectious Diseases . 30(5):449-454, October 2017.
Abstract:
Purpose of review: Dengue, the most common arbovirus, is an increasingly significant cause of morbidity worldwide. After decades of research, an approved tetravalent dengue vaccine is finally available. Models constructed using recently available vaccine efficacy data allow for a data-driven discussion of the potential impact of dengue vaccine deployment on global control.
Recent findings: Phase 3 efficacy trials demonstrated that the approved dengue vaccine, chimeric yellow fever–dengue–tetravalent dengue vaccine, has an efficacy of 60% against dengue illness of any severity. However, among dengue unexposed recipients, vaccination offers limited efficacy and may increase dengue severity. The WHO consequently recommends dengue vaccination for populations in which 70% of intended recipients are dengue seropositive. Models predict that routine childhood dengue vaccine may reduce dengue burden, but over time, population-level impact may be limited. Additional vaccine candidates in late-stage development may not suffer from the same limitations as chimeric yellow fever–dengue–tetravalent dengue vaccine.
Summary: The efficacy and safety profile of the recently approved dengue vaccine is favorable only in previously dengue exposed recipients, which limits its potential for global control. Future work must evaluate the approved vaccine’s long-term durability, efficacy of other late phase vaccine candidates, and potential for vector control efforts to work synergistically with vaccine deployment.

Influenza immunization of pregnant women in resource-constrained countries: an update for funding and implementation decisions

Current Opinion in Infectious Diseases
October 2017 – Volume 30 – Issue 5
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx
TROPICAL AND TRAVEL-ASSOCIATED DISEASES

Influenza immunization of pregnant women in resource-constrained countries: an update for funding and implementation decisions
Ortiz, Justin R.; Neuzil, Kathleen M.
Current Opinion in Infectious Diseases . 30(5):455-462, October 2017.
Abstract:
Purpose of review: In 2018, Gavi, the Vaccine Alliance, is expected to review the strategy of maternal influenza immunization for potential investment in low-income countries.
Recent findings: Clinical trial data confirm the efficacy of maternal influenza immunization to prevent influenza disease in both mothers and their infants during the first months of life. Trial and observational data indicate no significant adverse events in mothers or newborns. High-quality disease burden data, particularly for seasonal influenza in low-income and middle-income countries, are limited. Thus, the anticipated impact of maternal influenza immunization programs on severe illness is unclear. However, assessments of the public health value of investment in maternal influenza immunization should extend beyond calculations of disease prevention and include broader effects such as improving health systems for antenatal care delivery, preventing inappropriate antibacterial prescribing, building a platform for other vaccines to be used during pregnancy, and strengthening systems to regulate, procure, and distribute influenza vaccines in response to a future pandemic.
Summary: A global investment in a maternal influenza immunization strategy would prevent influenza disease in pregnant women and their infants. It would also provide additional public health value by strengthening antenatal care systems and improving country pandemic preparedness.

Steady progress toward a malaria vaccine

Current Opinion in Infectious Diseases
October 2017 – Volume 30 – Issue 5
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx
TROPICAL AND TRAVEL-ASSOCIATED DISEASES

Steady progress toward a malaria vaccine
Lyke, Kirsten E.
Current Opinion in Infectious Diseases . 30(5):463-470, October 2017.
Abstract:
Purpose of review: Great progress has been made in reducing malaria morbidity and mortality, yet the parasite continues to cause a startling 200 million infections and 500 000 deaths annually. Malaria vaccine development is pushing new boundaries by steady advancement toward a licensed product.
Recent findings: Despite 50 years of research, the complexity of Plasmoidum falciparum confounds all attempts to eradicate the organism. This very complexity has pushed the boundaries of vaccine development to new heights, yet it remains to be seen if an affordable vaccine can provide durable and high-level protection. Novel vaccines such as RTS,S/AS01E are on the edge of licensure, but old techniques have resurged with the ability to deliver vialed, whole organism vaccines. Novel adjuvants, multistage/multiantigen approaches and transmission blocking vaccines all contribute to a multipronged battle plan to conquer malaria.
Summary: Vaccines are the most cost-effective tools to control infectious diseases, yet the complexity of malaria has frustrated all attempts to develop an effective product. This review concentrates on recent advances in malaria vaccine development that lend hope that a vaccine can be produced and malaria eradicated.

Impact of rotavirus vaccines in low and middle-income countries

Current Opinion in Infectious Diseases
October 2017 – Volume 30 – Issue 5
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx
TROPICAL AND TRAVEL-ASSOCIATED DISEASES

Impact of rotavirus vaccines in low and middle-income countries
Sindhu, Kulandaipalayam Natarajan Chella; Babji, Sudhir; Ganesan, Santhosh Kumar
Current Opinion in Infectious Diseases . 30(5):473-481, October 2017.
Abstract:
Purpose of review: Rotavirus vaccines are playing a pivotal role in improving lives of infants and young children in low and middle-income countries (LMICs). Many of these countries have adopted the vaccine into their routine immunization, whereas others are considering introduction. This article provides an update on the impact of rotavirus vaccines in LMICs on morbidity and mortality in children aged less than 5 years, and their cost-effectiveness.
Recent findings: The WHO, in 2013, updated its recommendation to prioritize introduction of rotavirus vaccines in the routine immunization schedule, without age restrictions. Despite the decreased efficacy of the vaccines in LMICs, data from Sub-Saharan Africa have demonstrated a decrease in rotavirus-related morbidity, with some sites reporting an indirect protective effect on children age ineligible to receive the vaccine. Even with improvements in sanitation, nutritional status in children, and other health-related indices in LMICs, the use of rotavirus vaccines will play an important role in preventing rotavirus-related gastroenteritis. Economic models predict a reduction in economic burden because of rotavirus-related health costs, making vaccine introduction cost-effective in resource-constrained settings.
Summary: Increasing evidence from impact studies shows the significant impact of rotavirus vaccination on hospitalizations and economic burden because of rotavirus gastroenteritis in LMICs. Universal rotavirus vaccination is recommended, and introductions should be monitored by robust surveillance systems to measure effectiveness and impact.

The reproducibility “crisis”- Reaction to replication crisis should not stifle innovation

EMBO Reports
01 September 2017; volume 18, issue 9
http://embor.embopress.org/content/18/9?current-issue=y

Science & Society
The reproducibility “crisis”- Reaction to replication crisis should not stifle innovation
Philip Hunter
[Initial text]
The debate over a reproducibility crisis has been simmering for years now, amplified by growing concerns over a number of reproducibility studies that have failed to replicate previous positive results. Additional evidence from larger meta‐analysis of past papers also points to a lack of reproducibility in biomedical research with potentially dire consequences for drug development and investment into research. One of the largest meta‐analyses concluded that low levels of reproducibility, at best around 50% of all preclinical biomedical research, were delaying lifesaving therapies, increasing pressure on research budgets and raising costs of drug development [1]. The paper claimed that about US$28 billion a year was spent largely fruitlessly on preclinical research in the USA alone…

Health care and health innovation in Europe: regulating for public benefit or for commercial profit?

Health Economics, Policy and Law 
Volume 12 – Issue 4 – October 2017
https://www.cambridge.org/core/journals/health-economics-policy-and-law/latest-issue
SPECIAL ISSUE: Healthcare and Health Innovation in Europe: Regulating for public benefit or for commercial profit?

Editorial
Health care and health innovation in Europe: regulating for public benefit or for commercial profit?
Amanda Warren-Jones
DOI: https://doi.org/10.1017/S1744133117000081
Published online: 17 April 2017, pp. 403-40

Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire – a brave new world?

Health Economics, Policy and Law 
Volume 12 – Issue 4 – October 2017
https://www.cambridge.org/core/journals/health-economics-policy-and-law/latest-issue
SPECIAL ISSUE: Healthcare and Health Innovation in Europe: Regulating for public benefit or for commercial profit?

Articles
Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire – a brave new world?
Jean V. Mchale
DOI: https://doi.org/10.1017/S174413311700010X
Published online: 27 April 2017, pp. 435-452
Abstract
The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of ‘informed consent’ in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.

The SPARK Tool to prioritise questions for systematic reviews in health policy and systems research: development and initial validation

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 9 September 2017]

Research
The SPARK Tool to prioritise questions for systematic reviews in health policy and systems research: development and initial validation
Groups or institutions funding or conducting systematic reviews in health policy and systems research (HPSR) should prioritise topics according to the needs of policymakers and stakeholders. The aim of this st…
Elie A. Akl, Racha Fadlallah, Lilian Ghandour, Ola Kdouh, Etienne Langlois, John N. Lavis, Holger Schünemann and Fadi El-Jardali
Health Research Policy and Systems 2017 15:77
Published on: 4 September 2017

Doctoral level research and training capacity in the social determinants of health at universities and higher education institutions in India, China, Oman and Vietnam: a survey of needs

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 9 September 2017]

Research
Doctoral level research and training capacity in the social determinants of health at universities and higher education institutions in India, China, Oman and Vietnam: a survey of needs
Research capacity is scarce in low- and middle-income country (LMIC) settings. Social determinants of health research (SDH) is an area in which research capacity is lacking, particularly in Asian countries. SD…
Farhad Ali, Arun Shet, Weirong Yan, Abdullah Al-Maniri, Salla Atkins and Henry Lucas
Health Research Policy and Systems 2017 15:76
Published on: 2 September 2017

The research–policy–deliberation nexus: a case study approach

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 9 September 2017]

Research
The research–policy–deliberation nexus: a case study approach
Decision-makers tend to make connections with researchers far too late in the game of public policy, expecting to find a retail store in which researchers are busy filling shop-front shelves with a comprehensi…
Camille La Brooy and Margaret Kelaher
Health Research Policy and Systems 2017 15:75
Published on: 2 September 2017

The Neglected Diseases: Will a ‘New World Order’ Reverse Global Gains?

International Health
Volume 9, Issue 5, 1 September 2017
http://inthealth.oxfordjournals.org/content/current
EDITORIALS

The Neglected Diseases: Will a ‘New World Order’ Reverse Global Gains?
Peter J. Hotez
International Health, Volume 9, Issue 5, 1 September 2017, Pages 267–268, https://doi.org/10.1093/inthealth/ihx037
Extract
The concept of the ‘new world order’ refers to landmark historical events or changes in political thought, with resultant shifts in global power balances. Major new world order shifts in the 20th century include the formation and then collapse of the League of Nations, creating the United Nations after World War II, the Cold War, and the subsequent collapse of Communism. As we leave the 2010s and enter the 2020s, there are signs that yet another new world order is looming. Today we’re witnessing an increasingly globalized Russia and China (through a new ‘Belt and Road’ initiative), with commensurate reversals or retreats from globalization by the United States, United Kingdom, and some other European nations. In…

Addressing challenges to human health in the Anthropocene epoch—an overview of the findings of the Rockefeller/Lancet Commission on Planetary Health

International Health
Volume 9, Issue 5, 1 September 2017
http://inthealth.oxfordjournals.org/content/current

Addressing challenges to human health in the Anthropocene epoch—an overview of the findings of the Rockefeller/Lancet Commission on Planetary Health
Andy Haines
International Health, Volume 9, Issue 5, 1 September 2017, Pages 269–271, https://doi.org/10.1093/inthealth/ihx036
Extract
The report of the Rockefeller Foundation/Lancet Commission on Planetary Health1 described how human health ultimately depends on the state of the natural systems. It is complementary to the work of the Lancet Commission on Climate Change2 and takes a broader perspective on global environmental change, acknowledging that climate change is probably the single most important environmental change, but there are many others that can separately and in combination have wide ranging impacts on human health.

The Nuremberg Code 70 Years Later

JAMA
September 5, 2017, Vol 318, No. 9, Pages 771-878
http://jama.jamanetwork.com/issue.aspx

Viewpoint
The Nuremberg Code 70 Years Later
Jonathan D. Moreno, PhD; Ulf Schmidt, PhD; Steve Joffe, MD, MPH
JAMA. 2017;318(9):795-796. doi:10.1001/jama.2017.10265
Abstract
Seventy years ago, on August 20, 1947, the International Medical Tribunal in Nuremberg, Germany, delivered its verdict in the trial of 23 doctors and bureaucrats accused of war crimes and crimes against humanity for their roles in cruel and often lethal concentration camp medical experiments. As part of its judgment, the court articulated a 10-point set of rules for the conduct of human experiments that has come to be known as the Nuremberg Code. Among other requirements, the code called for the “voluntary consent” of the human research subject, an assessment of risks and benefits, and assurances of competent investigators. These concepts have become an important reference point for the ethical conduct of medical research. Yet, there has in the past been considerable debate among scholars about the code’s authorship, scope, and legal standing in both civilian and military science. Nonetheless, the Nuremberg Code has undoubtedly been a milestone in the history of biomedical research ethics.

Change in Medical Exemptions From Immunization in California After Elimination of Personal Belief Exemptions

JAMA
September 5, 2017, Vol 318, No. 9, Pages 771-878
http://jama.jamanetwork.com/issue.aspx

Research Letter
September 5, 2017
Change in Medical Exemptions From Immunization in California After Elimination of Personal Belief Exemptions
Paul L. Delamater, PhD1; Timothy F. Leslie, PhD2; Y. Tony Yang, ScD, LLM, MPH3
Author Affiliations
JAMA. 2017;318(9):863-864. doi:10.1001/jama.2017.9242
California Senate bill (SB) 277 eliminated the personal belief exemption (PBE) provision from the state’s school-entry vaccine mandates prior to the 2016-2017 school year. Previously, vaccine-hesitant parents could acquire a PBE for their child based on philosophical or religious beliefs. Now, the only pathway for an unvaccinated kindergartener to enter a public or private school in California is with a medical exemption (ME), which requires a written statement from a licensed physician describing the medical reasons that immunization is unsafe.1 Previously, MEs were only granted to children with a contraindication to vaccination; however, SB 277 gave physicians broader discretion to grant MEs for reasons other than a contraindication, including family medical history.2,3

Public Health and Economic Consequences of Vaccine Hesitancy for Measles in the United States

JAMA Pediatrics
September 2017, Vol 171, No. 9, Pages 823-924
http://archpedi.jamanetwork.com/issue.aspx

Original Investigation
Public Health and Economic Consequences of Vaccine Hesitancy for Measles in the United States
Nathan C. Lo, BS; Peter J. Hotez, MD, PhD
JAMA Pediatr. 2017;171(9):887-892. doi:10.1001/jamapediatrics.2017.1695
Key Points
Question  How does vaccine hesitancy affect annual measles cases and economic costs in the United States?
Findings  In this modeling study of children (age 2-11 years), a 5% reduction in measles, mumps, and rubella vaccination coverage resulted in a 3-fold increase in annual measles cases with an additional US$2.1 million in public sector costs.
Meaning  Even small declines in vaccination coverage in children owing to vaccine hesitancy may have substantial public health and economic consequences that will be larger when considering unvaccinated infants, adolescents, and adults.

Achieving an Optimal Childhood Vaccine Policy

JAMA Pediatrics
September 2017, Vol 171, No. 9, Pages 823-924
http://archpedi.jamanetwork.com/issue.aspx

Special Communication
Achieving an Optimal Childhood Vaccine Policy
Douglas J. Opel, MD, MPH; Jason L. Schwartz, PhD; Saad B. Omer, MBBS, PhD; et al.
JAMA Pediatr. 2017;171(9):893-896. doi:10.1001/jamapediatrics.2017.1868
Abstract
Policies to remove parents’ ability to opt-out from school immunization requirements on the basis of religious or personal beliefs (ie, nonmedical exemptions) may be a useful strategy to increase immunization rates and prevent outbreaks of vaccine-preventable disease. However, there is uncertainty about the effectiveness of this strategy and the range of possible outcomes. We advocate for a more deliberative process through which a broad range of outcomes is scrutinized and the balance of values underlying the policy decision to eliminate nonmedical exemptions is clearly articulated. We identify 3 outcomes that require particular consideration before policies to eliminate nonmedical exemptions are implemented widely and outline a process for making the values underlying such policies more explicit.

Influenza Vaccines for Older Persons: Progress and Pitfalls

Journal of Infectious Diseases
Volume 216, Issue 4   15 August 2017
https://academic.oup.com/jid/issue

EDITORIAL COMMENTARIES
Editor’s Choice
Influenza Vaccines for Older Persons: Progress and Pitfalls
Kathleen M Neuzil; Wilbur H Chen
The Journal of Infectious Diseases, Volume 216, Issue 4, 15 August 2017, Pages 397–398,
https://doi.org/10.1093/infdis/jix285
Extract
Influenza causes annual epidemics of varying severity that affect persons of all ages. In the older adult population, influenza constitutes a particularly important public health burden. In population-based modeling studies in the United States, hospitalization rates are consistently highest among persons aged ≥65 years of age [1]. Similarly, deaths are much more frequent among older persons than younger persons. In a modeling analysis of population-based surveillance data covering the 2010–2011 through the 2012–2013 seasons in the United States, an estimated 71%–85% of influenza-associated deaths occurred among adults aged ≥65 years [2]. Among those 65 years and older, certain factors such as.

The Importance of Frailty in the Assessment of Influenza Vaccine Effectiveness Against Influenza-Related Hospitalization in Elderly People

Journal of Infectious Diseases
Volume 216, Issue 4   15 August 2017
https://academic.oup.com/jid/issue

VIRUSES
Editor’s Choice
The Importance of Frailty in the Assessment of Influenza Vaccine Effectiveness Against Influenza-Related Hospitalization in Elderly People
Melissa K Andrew; Vivek Shinde; Lingyun Ye; Todd Hatchette; François Haguinet
The Journal of Infectious Diseases, Volume 216, Issue 4, 15 August 2017, Pages 405–414, https://doi.org/10.1093/infdis/jix282
Frailty has important impacts on influenza vaccine effectiveness (VE). Here, frailty was the most important confounder of VE, and not accounting for frailty underestimated VE. VE was high in nonfrail older adults, but diminished with increasing frailty.

Protection against HIV Acquisition in the RV144 Trial

Journal of Virology
September 2017, volume 91, issue 18
http://jvi.asm.org/content/current

Commentary
Protection against HIV Acquisition in the RV144 Trial
Ronald C. Desrosiers
University of Miami Miller School of Medicine, Miami, Florida, USA
Rozanne M. Sandri-Goldin, Editor
University of California, Irvine
ABSTRACT
Differences of opinion regarding whether there may, or may not, have been protective efficacy in the RV144 vaccine trial have important societal implications

Children first

Nature Medicine
September 2017, Volume 23 No 9 pp1005-1111
http://www.nature.com/nm/journal/v23/n8/index.html

Editorial
Children first
p1005
doi:10.1038/nm.4404
Drugs administered to children with cancer were typically developed under the assumption that childhood cancers are similar to their tissue-matched adult counterparts. Focusing on identifying and targeting alterations present specifically in childhood tumors will accelerate the development of tailored therapies and improve the prognosis of children with cancer.

Functional precision cancer medicine—moving beyond pure genomics

Nature Medicine
September 2017, Volume 23 No 9 pp1005-1111
http://www.nature.com/nm/journal/v23/n8/index.html

Perspective
Functional precision cancer medicine—moving beyond pure genomics
pp1028 – 1035
Anthony Letai
doi:10.1038/nm.4389
The essential job of precision medicine is to match the right drugs to the right patients. In cancer, precision medicine has been nearly synonymous with genomics. However, sobering recent studies have generally shown that most patients with cancer who receive genomic testing do not benefit from a genomic precision medicine strategy. Although some call the entire project of precision cancer medicine into question, I suggest instead that the tools employed must be broadened. Instead of relying exclusively on big data measurements of initial conditions, we should also acquire highly actionable functional information by perturbing—for example, with cancer therapies—viable primary tumor cells from patients with cancer.

Effectiveness of a Third Dose of MMR Vaccine for Mumps Outbreak Control

New England Journal of Medicine
September 7, 2017  Vol. 377 No. 10
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Effectiveness of a Third Dose of MMR Vaccine for Mumps Outbreak Control
Cristina V. Cardemil, M.D., M.P.H., Rebecca M. Dahl, M.P.H., Lisa James, R.N., M.S.N., Kathleen Wannemuehler, Ph.D., Howard E. Gary, Ph.D., Minesh Shah, M.D., M.P.H., Mona Marin, M.D., Jacob Riley, M.S., Daniel R. Feikin, M.D., Manisha Patel, M.D., and Patricia Quinlisk, M.D., M.P.H.
N Engl J Med 2017; 377:947-956 September 7, 2017 DOI: 10.1056/NEJMoa1703309
Conclusions
Students who had received a third dose of MMR vaccine had a lower risk of mumps than did those who had received two doses, after adjustment for the number of years since the second dose. Students who had received a second dose of MMR vaccine 13 years or more before the outbreak had an increased risk of mumps. These findings suggest that the campaign to administer a third dose of MMR vaccine improved mumps outbreak control and that waning immunity probably contributed to propagation of the outbreak. (Funded by the Centers for Disease Control and Prevention.)

Ecological Niche Modeling for Filoviruses: A Risk Map for Ebola and Marburg Virus Disease Outbreaks in Uganda

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 9 September 2017]

Research Article
Ecological Niche Modeling for Filoviruses: A Risk Map for Ebola and Marburg Virus Disease Outbreaks in Uganda
September 5, 2017 ·
Introduction: Uganda has reported eight outbreaks caused by filoviruses between 2000 to 2016, more than any other country in the world. We used species distribution modeling to predict where filovirus outbreaks are likely to occur in Uganda to help in epidemic preparedness and surveillance.
Methods: The MaxEnt software, a machine learning modeling approach that uses presence-only data was used to establish filovirus – environmental relationships. Presence-only data for filovirus outbreaks were collected from the field and online sources. Environmental covariates from Africlim that have been downscaled to a nominal resolution of 1km x 1km were used. The final model gave the relative probability of the presence of filoviruses in the study area obtained from an average of 100 bootstrap runs. Model evaluation was carried out using Receiver Operating Characteristic (ROC) plots. Maps were created using ArcGIS 10.3 mapping software.
Results: We showed that bats as potential reservoirs of filoviruses are distributed all over Uganda. Potential outbreak areas for Ebola and Marburg virus disease areas were predicted in West, Southwest and Central parts of Uganda, which corresponds to bat distribution and previous filovirus outbreaks areas. Additionally, the models predict the Eastern Uganda region and other areas that have not reported outbreaks before to be potential outbreak hotspots. Rainfall variables were the most important in influencing model prediction compared to temperature variables.
Conclusions: Despite the limitations in the prediction model due to lack of adequate sample records for outbreaks, especially for the Marburg cases, the model outputs provide a risk map to the Uganda surveillance system on filovirus outbreaks. The risk maps for potential filovirus outbreaks will aid in identifying areas to focus the filovirus surveillance for early detection and responses hence curtailing a pandemic. The results from this study also confirm previous findings that suggest that Filoviruses are mainly limited by the amount of rainfall received in an area.

Rapid and accurate interpretation of dengue diagnostics in the context of dengue vaccination implementation: Viewpoints and guidelines issued from an experts group consultation

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 9 September 2017)

Viewpoints
Rapid and accurate interpretation of dengue diagnostics in the context of dengue vaccination implementation: Viewpoints and guidelines issued from an experts group consultation
Elizabeth A. Hunsperger, Claudia N. Duarte dos Santos, Huong Thi Que Vu, Sutee Yoksan, Vincent Deubel
| published 07 Sep 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005719

Health care utilization in general practice after HPV vaccination—A Danish nationwide register-based cohort study

PLoS One
http://www.plosone.org/
[Accessed 9 September 2017]

Research Article
Health care utilization in general practice after HPV vaccination—A Danish nationwide register-based cohort study
Lene Wulff Krogsgaard, Claus Høstrup Vestergaard, Oleguer Plana-Ripoll, Tina Hovgaard Lützen, Mogens Vestergaard, Morten Fenger-Grøn, Bodil Hammer Bech, Dorte Rytter
Research Article | published 08 Sep 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0184658

Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com

PLoS One
http://www.plosone.org/
[Accessed 9 September 2017]

Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com
Derek So, Bartha M. Knoppers
Research Article | published 08 Sep 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0184491
Abstract
Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR), which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval. However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017. Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study. We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya

PLoS One
http://www.plosone.org/
[Accessed 9 September 2017]

Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya
Borna A. Nyaoke, Gaudensia N. Mutua, Rose Sajabi, Delvin Nyasani, Marianne W. Mureithi, Omu A. Anzala
Research Article | published 07 Sep 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0183788
Conclusion
The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation) to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine clinical trials.

Increasing the breadth and potency of response to the seasonal influenza virus vaccine by immune complex immunization

PNAS – Proceedings of the National Academy of Sciences of the United States
of America

http://www.pnas.org/content/early/
[Accessed 9 September 2017]

Biological Sciences – Immunology and Inflammation:
Increasing the breadth and potency of response to the seasonal influenza virus vaccine by immune complex immunization
Jad Maamary, Taia T. Wang, Gene S. Tan, Peter Palese, and Jeffrey V. Ravetch
PNAS 2017 ; published ahead of print September 5, 2017, doi:10.1073/pnas.1707950114
Significance
Influenza viruses remain a source of substantial morbidity and mortality worldwide. This is, in part, because current approaches to vaccination elicit strain-specific immune responses. Here, we report a method for targeting the Fc receptor, CD23, during vaccination with existing influenza vaccines (TIV) to increase the breadth and potency of the antibody response. Immunization with the TIV in complex with a monoclonal antibody that is broadly reactive against the hemagglutinin glycoprotein and engineered at the Fc domain to engage CD23 elicited antibodies that were 10-fold increased in potency and that protected against the potential pandemic influenza virus subtype H5N1 in vivo. This work demonstrates that broadly protective influenza immunity can be achieved using existing seasonal vaccines.
Abstract
The main barrier to reduction of morbidity caused by influenza is the absence of a vaccine that elicits broad protection against different virus strains. Studies in preclinical models of influenza virus infections have shown that antibodies alone are sufficient to provide broad protection against divergent virus strains in vivo. Here, we address the challenge of identifying an immunogen that can elicit potent, broadly protective, antiinfluenza antibodies by demonstrating that immune complexes composed of sialylated antihemagglutinin antibodies and seasonal inactivated flu vaccine (TIV) can elicit broadly protective antihemagglutinin antibodies. Further, we found that an Fc-modified, bispecific monoclonal antibody against conserved epitopes of the hemagglutinin can be combined with TIV to elicit broad protection, thus setting the stage for a universal influenza virus vaccine.

Identification of individuals by trait prediction using whole-genome sequencing data

PNAS – Proceedings of the National Academy of Sciences of the United States
of America

http://www.pnas.org/content/early/
[Accessed 9 September 2017]

Biological Sciences – Genetics:
Identification of individuals by trait prediction using whole-genome sequencing data
Christoph Lippert, Riccardo Sabatini, M. Cyrus Maher, Eun Yong Kang, Seunghak Lee, Okan Arikan, Alena Harley, Axel Bernal, Peter Garst, Victor Lavrenko, Ken Yocum, Theodore Wong,
Mingfu Zhu, Wen-Yun Yang, Chris Chang, Tim Lu, Charlie W. H. Lee, Barry Hicks, Smriti Ramakrishnan, Haibao Tang, Chao Xie, Jason Piper, Suzanne Brewerton, Yaron Turpaz,
Amalio Telenti, Rhonda K. Roby, Franz J. Och, and J. Craig Venter
PNAS 2017 ; published ahead of print September 5, 2017, doi:10.1073/pnas.1711125114
Significance
By associating deidentified genomic data with phenotypic measurements of the contributor, this work challenges current conceptions of genomic privacy. It has significant ethical and legal implications on personal privacy, the adequacy of informed consent, the viability and value of deidentification of data, the potential for police profiling, and more. We invite commentary and deliberation on the implications of these findings for research in genomics, investigatory practices, and the broader legal and ethical implications for society. Although some scholars and commentators have addressed the implications of DNA phenotyping, this work suggests that a deeper analysis is warranted.
Abstract
Prediction of human physical traits and demographic information from genomic data challenges privacy and data deidentification in personalized medicine. To explore the current capabilities of phenotype-based genomic identification, we applied whole-genome sequencing, detailed phenotyping, and statistical modeling to predict biometric traits in a cohort of 1,061 participants of diverse ancestry. Individually, for a large fraction of the traits, their predictive accuracy beyond ancestry and demographic information is limited. However, we have developed a maximum entropy algorithm that integrates multiple predictions to determine which genomic samples and phenotype measurements originate from the same person. Using this algorithm, we have reidentified an average of >8 of 10 held-out individuals in an ethnically mixed cohort and an average of 5 of either 10 African Americans or 10 Europeans. This work challenges current conceptions of personal privacy and may have far-reaching ethical and legal implications.
 

Squaring State Child Vaccine Policy With Individual Rights Under the Individuals With Disabilities Education Act: Questions Raised in California

Public Health Reports
Volume 132, Issue 5, September/October 2017
http://phr.sagepub.com/content/current

Law and the Public’s Health
Squaring State Child Vaccine Policy With Individual Rights Under the Individuals With Disabilities Education Act: Questions Raised in California
Ross D. Silverman, Wendy F. Hensel
First Published August 9, 2017; pp. 593–596

NIH’s massive health study is off to a slow start

Science         
08 September 2017  Vol 357, Issue 6355
http://www.sciencemag.org/current.dtl

Policy Forum
NIH’s massive health study is off to a slow start
By Jocelyn Kaiser
Science08 Sep 2017 : 955 Restricted Access
Summary
Nearly 3 years after then-President Barack Obama laid out a vision for perhaps the most ambitious and costly national health study ever, the U.S. National Institutes of Health (NIH) is still grappling with the complexities of the effort. The All of Us study aims to probe links between genes, lifestyle, and health by enrolling 1 million people for a long-term precision medicine study. NIH had once expected that by early 2017 it would enroll at least 10,000 participants for a pilot testing phase; it is up to just 2000. Its national kickoff, once envisioned for 2016 and then mid-2017, has been delayed as staff work out the complex logistics of the study, which is projected to cost $4.3 billion over 10 years. But study leaders say that for an endeavor this complex, delays are inevitable.