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

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

Editor’s Note:
We continue to lead this weekly digest with extensive coverage of polio and EVD – both designated as Public Health Emergencies of International Concern (PHEIC). We note that an International Health Regulations (IHR) Emergency Committee of Experts recommended last week, and the WHO DG affirmed, an extension of this status for polio as detailed below. On EVD, there is an apparent shifting – and softening – of key, stated milestones. The new stated target is control of EVD by the “middle of 2015.” Of course, these emergencies are playing out in a larger content of emergences which we summarize here [some countries listed are involved in the EVD emergency]:

Emergencies Scorecard
UN OCHA: L3 Emergencies [at 22 November 2014]
The UN and its humanitarian partners are currently responding to four ‘L3’ emergencies. This is the UN classification for the most severe, large-scale humanitarian crises.
:: Iraq: – The surge in violence between armed groups and government forces has displaced an estimated 1.8 million people across Iraq and left hundreds of thousands of people in need of assistance.
:: Syria – 10.8 million people, nearly half the population, are in need of humanitarian assistance. An estimated 6.45 million people have been displaced inside the country.
:: CAR Central African Repubic – The violence that erupted in December 2013 has displaced hundreds of thousands of people and left 2.5 million in urgent need of assistance.
:: South Sudan – About 1.4 million people are internally displaced as the result of fighting that began in December 2013. 3.8 million people need humanitarian assistance.

WHO: Public Health Emergencies of International Concern (PHEIC) [at 22 November 2014]
:: Ebola/EVD
:: Polio

WHO: Grade 3 and Grade 2 emergencies [at 22 November 2014]
:: WHO Grade 3 emergencies
– Central African Republic
– Guinea
– Iraq
– Liberia
– Nigeria
– Sierra Leone
– South Sudan
– The Syrian Arab Republic
:: WHO Grade 2 emergencies
– Democratic Republic of the Congo
– Guinea
– Mali
– occupied Palestinian territories
– Philippines
– Ukraine

POLIO [to 22 November 2014]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 19 November 2014
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: On 13 November, the Director-General of WHO accepted the recommendation of an International Health Regulations (IHR) Emergency Committee of Experts on polio that the international spread of polio continues to constitute a Public Health Emergency of International Concern (PHEIC) under the IHR, and extended the existing Temporary Recommendations to prevent the international spread of polio for countries affected by the disease for another 3 months. Recognizing the escalating wild poliovirus (WPV) transmission in Pakistan, additional Temporary Recommendations were provided to further reduce the risk of international spread from Pakistan. Read more below
:: In response to the recent outbreak of circulating vaccine-derived poliovirus (cVDPV) in Madagascar, supplementary immunization activities are scheduled in December in high risk areas and across the entire country in January to stop transmission of the virus.
:: This week, the Centers for Disease Control and Prevention (CDC), USA, released a report marking 2 years during which type 3 wild poliovirus has not been detected anywhere in the world. While the CDC report concludes that WPV3 transmission has possibly been interrupted, continued sensitive surveillance is needed before a final conclusion on WPV3 eradication can be made.
Afghanistan
:: Two new wild poliovirus type 1 (WPV1) cases were reported in the past week in Afghanistan. One was found in Nahr-E-Saraj district of Hilmand province, and the second was reported from Zheray district of Kandahar province. Both areas had not reported WPV1 previously during 2014. The total number of WPV1 cases for 2014 in Afghanistan is now 20. The most recent WPV1 case had onset of paralysis on 20 October, from Kandahar province.
Nigeria
:: Five new type 2 circulating vaccine-derived poliovirus (cVDPV2) cases were reported in the past week, all in districts or states that had not reported cVDPV2 during 2014 to date. One case was in Guzamala district, Borno; 1 in Kura district, Kano; 1 in Barde district, Yobe; and 1 in each Dutse and Kiyawa districts, Jigawa. The total number of cVDPV2 cases for 2014 in Nigeria is now 26. The most recent cVDPV2 case had onset of paralysis on 16 October, in Barde district, Yobe state.
:: In selected high risk areas of Kano state, supplementary immunization activities (SIAs) using both inactivated polio vaccine (IPV) and oral polio vaccine (OPV) are taking place from 15 – 20 November. Large-scale Subnational Immunization Days (SNIDs) are planned for 13 – 16 December across northern Nigeria. The aim is to boost immunity to all strains of poliovirus, to rapidly interrupt circulation of both WPV1 and cVDPV2.
Pakistan
:: Ten new wild poliovirus type 1 (WPV1) cases were reported in the past week. Six were from the Federally Administered Tribal Areas (FATA), with 1 in South Waziristan, and 5 in Khyber Agency; 1 from Killa Abdullah district in Balochistan province; 1 from Mardin district in Khyber Pakhtunkhwa province; and 2 from Sindh province (1 in Bin Qasim town of Karachi city and 1 in Badin district, southern Sindh province). The total number of WPV1 cases in Pakistan in 2014 is now 246, compared to 63 at this time last year. The most recent WPV1 case had onset of paralysis on 1 November, from Khyber
:: Immunization activities are continuing with particular focus on known high-risk areas, in particular newly opened previously inaccessible areas of FATA. At exit and entry points of conflict-affected areas that are still inaccessible during polio campaigns, 100 permanent vaccination points are being used to reach internally displaced families as they move in and out of the inaccessible area. Over 1 million people have been vaccinated in the past few months at transit points and in host communities, including over 850,000 children under 10 years old.
Horn of Africa
:: Following confirmation of two cases of circulating vaccine derived poliovirus type 2 (cVDPV2) in a refugee camp area of Unity state, South Sudan, two weeks ago, preparations for outbreak response immunization activities are being finalized in the country. National Immunization Days (NIDs) were implemented on 4–7 November, with further campaigns planned for December and January. The objective is to rapidly stop the cVDPV2 in the infected area, while further boosting immunity to type 1 polio and to minimize the risk of renewed outbreaks following virus re-introduction from infected countries and areas.

WHO statement on the third meeting of the International Health Regulations Emergency Committee regarding the international spread of wild poliovirus
WHO statement
14 November 2014
[Excerpts]
The third meeting of the Emergency Committee under the IHR (2005) regarding the international spread of wild poliovirus in 2014 was convened by the Director-General through electronic correspondence from 2 through 7 November 2014.1 The following IHR States Parties submitted an update on the implementation of the Temporary Recommendations since the Committee last met on 31 July 2014: Cameroon, Equatorial Guinea, Pakistan and the Syrian Arab Republic.

The Committee noted that the international spread of wild poliovirus has continued since 31 July 2014, with at least 3 new exportations from Pakistan into neighbouring Afghanistan. There has been no other documented international spread of wild poliovirus since March 2014.

The risk of new international spread from Pakistan was assessed to have increased substantively since 31 July 2014, as cases have escalated during the current high transmission season and there has been no significant improvement in the underlying factors that are driving transmission in the country. The risk of new international spread from the other 9 currently infected States appears to have declined, with only 2 of those States having reported new cases since 31 July: Somalia (1 case) and Afghanistan (7 cases, most of which were due to imported virus).

The Committee remains concerned that implementation of the Temporary Recommendations is still incomplete, especially as immunization systems have continued to deteriorate in a number of the countries at greatest risk of new importations, particularly those affected by conflict…

…The Committee assessed that the event still constitutes a Public Health Emergency of International Concern and recommended the extension of the Temporary Recommendations for a further 3 months.

Recognizing the escalating wild poliovirus transmission in Pakistan, with more reported cases than at any time in the past 14 years and ongoing cross-border exportation of the virus, the Committee provided the following additional advice to the Director-General for her consideration to reduce further the risk of international spread of wild poliovirus:
– Pakistan should restrict at the point of departure the international travel of any resident lacking documentation of appropriate polio vaccination. These recommendations apply to international travellers from all points of departure, irrespective of the means of conveyance (e.g. road, air, sea);
– Pakistan should note that the recommendation stated previously for urgent travel remains valid (i.e. those undertaking urgent travel who have not received appropriate polio vaccination must receive a dose of polio vaccine at least by the time of departure and be provided with appropriate documentation of that dose);
– in advance of the next meeting of the Committee, Pakistan should provide to the Director-General a report on the implementation by month of the Temporary Recommendations on international travel, including the number of residents whose travel was restricted and the number of travellers who were vaccinated and provided appropriate documentation at the point of departure.

If the existing and additional Temporary Recommendations for the vaccination of travellers from Pakistan cannot be fully implemented by the time the Committee next meets, the Committee will consider additional measures such as entry screening to reduce the risk of international spread.

The Director-General accepted the Committee’s assessment and declared that the international spread of wild poliovirus continued to constitute a PHEIC. The Director-General endorsed the Committee’s additional advice on reducing the risk of international spread from Pakistan…

UNICEF [to 22 November 2014]
http://www.unicef.org/media/media_71724.html

In West Africa, countries at risk of Ebola remain on high alert: UNICEF
DAKAR/GENEVA/NEW YORK, 21 November 2014 – With new Ebola cases in Mali and a continuing surge in Sierra Leone, UNICEF is stepping up efforts to help other West African countries at risk prepare for potential outbreaks.
“The new cases in Mali remind us that no country in the region is immune to Ebola,” said Manuel Fontaine, UNICEF Regional Director for West and Central Africa. “We cannot wait for new cases in countries at risk before we take action. We must help communities today prepare for cases if they happen, when they happen, wherever they happen.”
In recent months, UNICEF has worked with all West and Central African countries to review their prevention and preparedness plans. In the 13 countries most at risk, focus has been on dispelling rumours, sharing life-saving information and providing supplies such as mattresses, soap, hydro-alcoholic gel, bleach, buckets, laser thermometers, gloves, diarrheal disease packages, syringes, tarpaulins and tents…

Scotland and England unite to protect children from Ebola
LONDON, UK, 16 November 2014 – An urgent television appeal to help protect children in danger from the deadliest ever Ebola outbreak will be broadcast during the England v Scotland international on Tuesday night to raise money for Unicef’s Emergency Ebola Appeal.

CDC/MMWR Watch [to 22 November 2014]
http://www.cdc.gov/media/index.html
:: CDC and USAID update on Liberia Ebola Response
November 20, 2014 – Press Briefing Transcript – Audio only Audio recording[MP3, 10.3 MB]
:: Enhanced Airport Entry Screening to Begin for Travelers to the United States from Mali – Press Release – Sunday, November 16, 2014

MMWR November 21, 2014 / Vol. 63 / No. 46
– Global Routine Vaccination Coverage, 2013
– Progress Toward Poliomyelitis Eradication — Nigeria, January 2013–September 2014
– Update: Ebola Virus Disease Epidemic — West Africa, November 2014
– Evidence for a Decrease in Transmission of Ebola Virus — Lofa County, Liberia, June 8–November 1, 2014
– Evidence for Declining Numbers of Ebola Cases — Montserrado County, Liberia, June–October 2014
– Ebola Virus Disease Cases Among Health Care Workers Not Working in Ebola Treatment Units — Liberia, June–August, 2014
– Ebola Epidemic — Liberia, March–October 2014
– Ebola Virus Disease Cluster in the United States — Dallas County, Texas, 2014
– Response to Importation of a Case of Ebola Virus Disease — Ohio, October 2014

BMGF – Gates Foundation Watch [to 22 November 2014]
http://www.gatesfoundation.org/Media-Center/Press-Releases

NOVEMBER 18, 2014
Gates Foundation Announces Support to Ebola-Affected Countries To Accelerate the Evaluation of Potential Treatments
SEATTLE (November 18, 2014) – The Bill & Melinda Gates Foundation today announced that it will be supporting efforts in Guinea and other Ebola-affected countries to scale up the production and evaluation of convalescent plasma and other convalescent blood products as potential therapies for people infected with the Ebola virus. Various drug candidates will also be evaluated, including the experimental antiviral drug brincidofovir.

The foundation has committed $5.7 million to launch the effort, and specific trial designs and locations will be confirmed in coordination with national health authorities and the World Health Organization.

“We are committed to working with Ebola-affected countries to rapidly identify and scale up potential lifesaving treatments for Ebola,” said Dr. Papa Salif Sow, a senior program officer and infectious diseases expert with the foundation’s Global Health Program. “The Gates Foundation is focusing its R&D investments on treatments, diagnostics, and vaccines that we believe could be quickly produced and delivered to those who need them if they demonstrate efficacy in stopping the disease.”

[The press release lists 27 partners involved in the efforts including companies, foundations, and academic and research centers.]

Global Emerging Pathogen Treatment Consortium Formed To Study Potential Of Immune Plasma Treatment In The Fight Against Ebola
African-led Group of Clinicians, Blood Banks and Social Science Experts, in Collaboration with U.S.-based Clinical RM and United States Army Medical Research Institute of Infectious Diseases, Work to Identify a Better Understanding and Solutions to Ebola Outbreak

HINCKLEY, Ohio, Nov. 19, 2014 /PRNewswire/ — An African-led scientific team in collaboration with U.S.-based Clinical Research Management, Inc. (ClinicalRM), and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) today announced the assembly of the Global Emerging Pathogens Therapy/Treatment (GET) Consortium.

This group of medical and project management experts from all the geopolitical regions of Africa, Europe, Asia and the United States, is pooling resources to assess the efficacy of immune plasma collected from survivors of Ebola Virus Disease (EVD) in West Africa. The Consortium, whose plan is closely aligned with the WHO position paper on collection and use of convalescent plasma or serum as an element in Filovirus outbreak response, expects to begin clinical trials in November 2014. Members from the GET Consortium are also acting as key scientific advisors for the effort in West Africa related to convalescent plasma for the treatment of Ebola virus disease recently announced by the Bill & Melinda Gates Foundation…

WHO [to 22 November 2014]
WHO Director-General addresses the Second International Conference on Nutrition
19 November 2014

Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: Plague – Madagascar 21 November 2014
[Excerpt]
21 November 2014 – On 4 November 2014, WHO was notified by the Ministry of Health of Madagascar of an outbreak of plague. The first case, a male from Soamahatamana village in the district of Tsiroanomandidy, was identified on 31 August. The patient died on 3 September.
As of 16 November, a total of 119 cases of plague have been confirmed, including 40 deaths. Only 2% of reported cases are of the pneumonic form.
Cases have been reported in 16 districts of seven regions. Antananarivo, the capital and largest city in Madagascar, has also been affected with 2 recorded cases of plague, including 1 death. There is now a risk of a rapid spread of the disease due to the city’s high population density and the weakness of the healthcare system. The situation is further complicated by the high level of resistance to deltamethrin (an insecticide used to control fleas) that has been observed in the country.
Public health response
The national task force has been activated to manage the outbreak. With support from partners – including WHO, the Pasteur Institute of Madagascar, the “Commune urbaine d’Antananarivo” and the Red Cross – the government of Madagascar has put in place effective strategies to control the outbreak. Thanks to financial assistance from the African Development Bank, a 200,000 US dollars response project has been developed. WHO is providing technical expertise and human resources support. Measures for the control and prevention of plague are being thoroughly implemented in the affected districts. Personal protective equipment, insecticides, spray materials and antibiotics have been made available in those areas…
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 21 November 2014
:: Human infection with avian influenza A(H7N9) virus – China 18 November 2014

News releases
:: Worldwide action needed to address hidden crisis of violence against women and girls  21 November 2014
:: Countries vow to combat malnutrition through firm policies and actions 19 November 2014
:: UN reveals major gaps in water and sanitation – especially in rural areas 19 November 2014

WHO Regional Offices [to 22 November 2014]
WHO African Region AFRO
No new digest content identified.

WHO Region of the Americas PAHO
:: ‘No child should die from a preventable cause,’ says PAHO/WHO on Universal Children’s Day
In the Americas, under-5 mortality has fallen more than two-thirds since 1990, but not all children have benefited equally from this progress
Washington, D.C., 19 November, 2014 (PAHO/WHO) — Despite impressive progress in child survival in the Americas over the past quarter-century, vulnerable children—especially those from indigenous, rural and low-income families—remain more likely to die before age 5 than other children.
On Universal Children’s Day, celebrated on November 20 each year, the Pan American Health Organization/World Health Organization (PAHO/WHO) is calling on its member countries to address inequities in child health so that no child dies from a preventable cause, regardless of their ethnicity, their family’s income level, or where they live…
:: PAHO, OAS and IDB explore joint action on outbreak response in the Americas
Washington, D.C., 18 November 2014 (PAHO/WHO) – The Director of the Pan American Health Organization/World Health Organization (PAHO/WHO), Dr. Carissa F. Etienne, met this week with Secretary-General of the OAS José Miguel Insulza and President of the Inter-American Development Bank Luis Alberto Moreno to explore joint action to strengthen the capacity of countries in the Americas to respond to disease outbreaks and epidemics.
In their meeting, at IDB headquarters in Washington, D.C., the heads of the three inter-American organizations discussed the health and economic challenges posed to the region by new diseases such as chikungunya, which was first detected in the Caribbean in December 2013, and Ebola, which to date has only been reported in one country of the Western Hemisphere, the United States.
The leaders agreed to explore the possible establishment of an inter-American fund for outbreak preparedness, which would support strengthening for surveillance systems and health services to ensure rapid and effective response to outbreaks in the region.
They also agreed that the three organizations would contribute to strengthening country capacities to respond to disease and other health risks in the framework of the International Health Regulations (IHR), an international legal instrument that has been signed by WHO Member States to help prevent and respond to public health risks that can cross borders and threaten countries around the world…

WHO South-East Asia Region SEARO
:: World Toilet Day 2014
Inadequate sanitation is impacting health and economies of countries in South-East Asia. Good sanitation is proven to prevent water sources being contaminated, protect the environment, prevent infectious diseases and help reduce malnutrition, stunting and mental stress.
– The health and economic cost of poor sanitation – Dr Poonam Khetrapal Singh
– World Toilet Day 2014 – Improving sanitation would deliver enormous economic benefits

WHO European Region EURO
:: Consultation on sustainable access to vaccines in middle-income countries 24–25 November 2014, Istanbul, Turkey
:: Workshop on immunization financing and graduation from GAVI support 25–28 November 2014, Istanbul, Turkey

WHO Eastern Mediterranean Region EMRO
:: Haemophilus influenzae vaccine introduced in all national immunization programmes
20 November 2014

WHO Western Pacific Region WPRO
:: Let’s use antibiotics responsibly
ANILA, 21 November 2014 – Antimicrobial resistance (AMR) is a global public health threat. The rapid rise and spread of AMR—especially antibiotic resistance—places the well-being of the Western Pacific Region’s 1.8 billion people at risk. During Antibiotic Awareness Week (17–23 November 2014), the World Health Organization (WHO) urges everyone to use antibiotics responsibly, so these drugs can continue to protect our families and communities from harmful bacteria…
:: WHO leads meeting to strengthen health security in the Pacific
20 November 2014 SUVA, Fiji – Health leaders from 21 Pacific island countries and areas will meet in Nadi, Fiji to discuss progress in the implementation of the International Health Regulations (IHR) in the Pacific. Preparedness to respond to the deadly Ebola virus, should the virus be imported into the Pacific region by a traveller returning from West Africa, will be a key item for discussion…

Sabin Vaccine Institute Watch [to 22 November 2014]
http://www.sabin.org/updates/pressreleases

Statement by Amb. Michael Marine, CEO of the Sabin Vaccine Institute, on the Passing of Morton P. Hyman
Morton P. Hyman, a renowned philanthropic and public health leader and Chairman of the Sabin Vaccine Institute Board of Trustees, passed away peacefully yesterday surrounded by his family and loved ones. Sabin CEO, Ambassador Michael W. Marine, reflecting on the profound difference that Mort made during his lifetime, released a statement..

IDRI Announces $11.9M Contract To Develop Thermostable TB Vaccine
Using freeze-drying process to overcome cold-chain transportation issues
SEATTLE, Nov. 19, 2014 /PRNewswire-USNewswire/ — With the goal of developing a thermostable tuberculosis vaccine that is resistant to damage from excessive heat or cold, IDRI (Infectious Disease Research Institute) today announces it has been awarded a contract from the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health. The contract (HHSN272201400041C) has a base award of $3.6 million and could be worth up to $11.9 million if all milestone-driven options are exercised. The contract provides funding for a team of IDRI scientists – led by Christopher Fox, Ph.D. – to develop, produce and test a thermostable lyophilized formulation of its vaccine candidate to prevent tuberculosis. TB-causing bacteria infect an estimated one-third of the global population, and, in 2013, approximately nine million people developed active cases of TB illness…

SRA Wins $18 Million Contract to Support Vaccine Adverse Event Reporting System
FAIRFAX, Va., Nov. 17, 2014 /PRNewswire/ — SRA International, Inc…was awarded a contract to support the Vaccine Adverse Event Reporting System (VAERS) co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration. The contract includes a base year plus four option years and is valued at $18 million if all options are exercised.

VAERS “is a national vaccine safety surveillance program that collects reports from vaccine manufacturers, providers, and recipients about possible side effects, or adverse events, that occur after the administration of vaccines licensed for use in the United States. VAERS searches the reports to: 1) detect new, unusual, or rare vaccine adverse events; 2) monitor increases in known adverse events; 3) identify potential patient risk factors for particular types of adverse events; 4) identify vaccine lots with increased numbers or types of reported adverse events; and 5) assess the safety of newly licensed vaccines.”

Under the contract, SRA will apply a wide range of skills and expertise to support the system including application development and maintenance, data processing/management, medical coding, clinical research, information technology and outreach to the public, vaccine manufacturers and immunization programs…

Global Fund Watch [to 22 November 2014]
:: Global Fund Board Considers Strategy, Governance, Ethics
21 November 2014
MONTREUX, Switzerland – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria convened a week-long gathering including a retreat on strategy, governance and ethics, followed by extensive constituency meetings and a formal meeting attended by 20 Board members and nearly 200 delegates and observers from all over the world.
The Board meets twice a year to exercise its responsibility of monitoring and oversight, and to make decisions that guide nearly US$4 billion of funding each year for programs in more than 140 countries that are accelerating the end of HIV, TB and malaria as epidemics.

At the meeting, Board members consistently stressed the importance of focusing on gender, human rights and strengthening health and community systems – each of them critical factors in achieving impact against HIV, TB and malaria. Board members also cited the Ebola outbreak as an instance of global concern where joint action by partners and health systems strengthening is essential.

This year, the Global Fund began full implementation of a new funding model that is designed to better serve people affected by HIV, TB and malaria by improving the process of devising grants with flexible timing, better alignment with national strategies and active engagement with implementers and partners.

The Board reviewed several aspects of the new approach to funding. More than 100 concept notes have already been submitted for the 2014-2016 allocation period. Many eligible countries are still developing concept notes and expect to submit them in the coming months…

NIH Watch [to 22 November 2014]
http://www.nih.gov/news/index.html

:: HHS and NIH take steps to enhance transparency of clinical trial results
The U.S. Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health. A major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products.
“Medical advances would not be possible without participants in clinical trials,” said NIH Director Francis S. Collins, M.D., Ph.D. “We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.”…

Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion
BOSTON – Nov. 18, 2014 – Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development.

The $2,558 million figure per approved compound is based on estimated:
:: Average out-of-pocket cost of $1,395 million
:: Time costs (expected returns that investors forego while a drug is in development) of $1,163 million
:: Estimated average cost of post-approval R&D—studies to test new indications, new formulations, new dosage strengths and regimens, and to monitor safety and long-term side effects in patients required by the U.S. Food and Drug Administration as a condition of approval—of $312 million boosts the full product lifecycle cost per approved drug to $2,870 million. All figures are expressed in 2013 dollars.

The new analysis, which updates similar Tufts CSDD analyses, was developed from information provided by 10 pharmaceutical companies on 106 randomly selected drugs that were first tested in human subjects anywhere in the world from 1995 to 2007.

“Drug development remains a costly undertaking despite ongoing efforts across the full spectrum of pharmaceutical and biotech companies to rein in growing R&D costs,” said Joseph A. DiMasi, director of economic analysis at Tufts CSDD and principal investigator for the study.

He added, “Because the R&D process is marked by substantial technical risks, with expenditures incurred for many development projects that fail to result in a marketed product, our estimate links the costs of unsuccessful projects to those that are successful in obtaining marketing approval from regulatory authorities.”

In a study published in 2003, Tufts CSDD estimated the cost per approved new drug to be $802 million (in 2000 dollars) for drugs first tested in human subjects from 1983 to 1994, based on average out-of-pocket costs of $403 million and capital costs of $401 million.

The $802 million, equal to $1,044 million in 2013 dollars, indicates that the cost to develop and win marketing approval for a new drug has increased by 145% between the two study periods, or at a compound annual growth rate of 8.5%.

According to DiMasi, rising drug development costs have been driven mainly by increases in out-of-pocket costs for individual drugs and higher failure rates for drugs tested in human subjects.
Factors that likely have boosted out-of-pocket clinical costs include increased clinical trial complexity, larger clinical trial sizes, higher cost of inputs from the medical sector used for development, greater focus on targeting chronic and degenerative diseases, changes in protocol design to include efforts to gather health technology assessment information, and testing on comparator drugs to accommodate payer demands for comparative effectiveness data.

Lengthening development and approval times were not responsible for driving up development costs, according to DiMasi.
“In fact,” DiMasi said, “changes in the overall time profile for development and regulatory approval phases had a modest moderating effect on the increase in R&D costs. As a result, the time cost share of total cost declined from approximately 50% in previous studies to 45% for this study.”

The study was authored by DiMasi, Henry G. Grabowski of the Duke University Department of Economics, and Ronald W. Hansen at the Simon Business School at the University of Rochester.

American Journal of Public Health
Volume 104, Issue 12 (December 2014)
http://ajph.aphapublications.org/toc/ajph/current

Transforming Public Health Delivery Systems With Open Science Principles
Glen P. Mays, PhD, MPH, and F. Douglas Scutchfield, MD
Glen Mays is with the National Coordinating Center for Public Health Services and Systems Research, Department of Health Management and Policy, College of Public Health, The University of Kentucky, Lexington. F. Douglas Scutchfield is with the Colleges of Medicine and Public Health, The University of Kentucky.
[No abstract]

The Effects of the State of Tennessee Immunization Policy Change of 2011–2012 on Vaccination Uptake in East Tennessee
Margaret A. Knight, Anne D. Kershenbaum, Martha Buchanan, Janet Ridley, Paul C. Erwin
American Journal of Public Health: December 2014, Vol. 104, No. 12: e39–e39.
[No abstract]

The Texas Children’s Hospital Immunization Forecaster: Conceptualization to Implementation
Rachel M. Cunningham, MPH, Leila C. Sahni, MPH, G Brady Kerr, BSN, Laura L. King, MSN, Nathan A. Bunker, BS, and Julie A. Boom, MD
Rachel M. Cunningham, Leila C. Sahni, G. Brady Kerr, Laura L. King, and Julie A. Boom are with the Immunization Project, Texas Children’s Hospital, Houston. Nathan A. Bunker is with Dandelion Software & Research, Inc., Toquerville, UT.
Abstract
Objectives. Immunization forecasting systems evaluate patient vaccination histories and recommend the dates and vaccines that should be administered. We described the conceptualization, development, implementation, and distribution of a novel immunization forecaster, the Texas Children’s Hospital (TCH) Forecaster.
Methods. In 2007, TCH convened an internal expert team that included a pediatrician, immunization nurse, software engineer, and immunization subject matter experts to develop the TCH Forecaster. Our team developed the design of the model, wrote the software, populated the Excel tables, integrated the software, and tested the Forecaster. We created a table of rules that contained each vaccine’s recommendations, minimum ages and intervals, and contraindications, which served as the basis for the TCH Forecaster.
Results. We created 15 vaccine tables that incorporated 79 unique dose states and 84 vaccine types to operationalize the entire United States recommended immunization schedule. The TCH Forecaster was implemented throughout the TCH system, the Indian Health Service, and the Virginia Department of Health. The TCH Forecast Tester is currently being used nationally.
Conclusions. Immunization forecasting systems might positively affect adherence to vaccine recommendations. Efforts to support health care provider utilization of immunization forecasting systems and to evaluate their impact on patient care are needed.

A Public Health Achievement Under Adversity: The Eradication of Poliomyelitis From Peru, 1991
Deepak Sobti, MD, Marcos Cueto, PhD, and Yuan He, BS
Abstract
The fight to achieve global eradication of poliomyelitis continues. Although native transmission of poliovirus was halted in the Western Hemisphere by the early 1990s, and only a few cases have been imported in the past few years, much of Latin America’s story remains to be told. Peru conducted a successful flexible, or flattened, vertical campaign in 1991. The initial disease-oriented programs began to collaborate with community-oriented primary health care systems, thus strengthening public–private partnerships and enabling the common goal of poliomyelitis eradication to prevail despite rampant terrorism, economic instability, and political turmoil. Committed leaders in Peru’s Ministry of Health, the Pan American Health Organization, and Rotary International, as well as dedicated health workers who acted with missionary zeal, facilitated acquisition of adequate technologies, coordinated work at the local level, and increased community engagement, despite sometimes being unable to institutionalize public health improvements.

Annals of Internal Medicine
4 November 2014, Vol. 161. No. 9
http://annals.org/issue.aspx

Ideas and Opinions | 18 November 2014
Ebola, Ethics, and Public Health: What Next?
Nancy Kass, ScD
FREE
[Initial text]
Ebola virus disease has ignited some of our worst fears in a globalized world. The disease spreads quickly, with high mortality, and is crossing borders. More than half of infected persons have died (1). The confirmed cases include 2 Americans who have become the focus of public attention because of their heroism and for the extraordinary measures taken to ensure that they received optimum medical care.

With this attention, 3 ethics questions are being asked: Should the 2 Americans have been airlifted out of Liberia when others were not? Should they have been given a highly experimental treatment? And if treating them was appropriate, should the hundreds of Africans with Ebola also be treated?
Despite codes of ethics requiring physicians not to abandon sick patients (2), few health professionals would probably volunteer to care for patients with Ebola in West Africa today. Sound medical ethics is one thing, but traveling to help patients with an illness both highly contagious and usually fatal is what ethics calls “supererogatory’—above and beyond usual norms of good ethical conduct.

When a health care provider is willing to work amidst Ebola (or the severe acute respiratory syndrome or pandemic influenza), we, as a society, must fulfill our end of the bargain. It would be unconscionable to send physicians and nurses to Africa now without hazardous material suits, and it would be equally unconscionable not to assure them that, should they contract Ebola, they would be airlifted home to receive the best care available. It would clearly be better for persons in at-risk areas if they, too, had access to protective equipment and airlifts. The tragedy of people dying in Africa from this killer virus does not make our special treatment of the physicians and nurses who fly in to help them unfair…

BMC Infectious Diseases
(Accessed 22 November 2014)
http://www.biomedcentral.com/bmcinfectdis/content

Research article
Tuberculosis care for pregnant women: a systematic review
Hang Thanh Nguyen1*, Chiara Pandolfini1, Peter Chiodini2 and Maurizio Bonati1
Author Affiliations
BMC Infectious Diseases 2014, 14:617 doi:10.1186/s12879-014-0617-x
Published: 19 November 2014
Abstract
Background
Tuberculosis (TB) during pregnancy may lead to severe consequences affecting both mother and child. Prenatal care could be a very good opportunity for TB care, especially for women who have limited access to health services. The aim of this review was to gather and evaluate studies on TB care for pregnant women.
Methods
We used a combination of the terms “tuberculosis” and “pregnancy”, limited to human, to search for published articles. Studies reflecting original data and focusing on TB care for pregnant women were included. All references retrieved were collected using the Reference Manager software (Version 11).
Results
Thirty five studies were selected for review and their data showed that diagnosis was often delayed because TB symptoms during pregnancy were not typical. TB prophylaxis and anti-TB therapy appeared to be safe and effective for pregnant women and their babies when suitable follow up and early initiation were present, but the compliance rate to TB prophylaxis is still low due to lack of follow up and referral services. TB care practices in the reviewed studies were in line in principle with the WHO International Standards for Tuberculosis Care (ISTC).
Conclusions
Integration of TB care within prenatal care would improve TB diagnosis and treatment for pregnant women. To improve the quality of TB care, it is necessary to develop national level guidelines based on the ISTC with detailed guidelines for pregnant women.

BMC Medical Ethics
(Accessed 22 November 2014)
http://www.biomedcentral.com/bmcmedethics/content

Research article
Consenting for current genetic research: is Canadian practice adequate?
Iris Jaitovich Groisman, Nathalie Egalite and Beatrice Godard
Author Affiliations
BMC Medical Ethics 2014, 15:80 doi:10.1186/1472-6939-15-80
Published: 20 November 2014
Abstract (provisional)
Background
In order to ensure an adequate and ongoing protection of individuals participating in scientific research, the impacts of new biomedical technologies, such as Next Generation Sequencing (NGS), need to be assessed. In this light, a necessary reexamination of the ethical and legal structures framing research could lead to requisite changes in informed consent modalities. This would have implications for Institutional Review Boards (IRBs), who bear the responsibility of guaranteeing that participants are verifiably informed, and in sufficient detail, to understand the reality of genetic research as it is practiced now. Current literature allowed the identification of key emergent themes related to the consent process when NGS was used in a research setting.
Methods
We examined the subjects of secondary use, sharing of materials and data, and recontacting participants as outlined in the Canadian Informed Consent templates and the accompanying IRB instructions for the conduct of genetic research. The research ethics policy applied by the three Canadian research agencies (Tri-Council Policy Statement, 2nd Edition) was used to frame our content analysis. We also obtained IRB-approved consent forms for genetic research projects on brain and mental health disorders as an example of a setting where participants might present higher-than-average vulnerability.
Results
Eighty percent of documents addressed different modalities for the secondary use of material and/or data, although the message was not conveyed in a systematic way. Information on the sharing of genetic sequencing data in a manner completely independent of the material from which it originated was absent. Grounds for recontacting participants were limited, and mainly mentioned to obtain consent for secondary use. A feature of the IRB-approved consent documents for genetic studies on brain and mental health disorders using NGS technologies, offered a complete explanation on sharing material and data and the use of databases.
Conclusions
The results of our work show that in Canada, many NGS research needs are already dealt with. Our analysis led us to propose the addition of well-defined categories for future use, adding options on the sharing of genetic data, and widening the grounds on which research participants could consent to be recontacted.

BMC Public Health
(Accessed 22 November 2014)
http://www.biomedcentral.com/bmcpublichealth/content

Research article
Determinants of vaccination coverage and adherence to the Greek national immunization program among infants aged 2-24 months at the beginning of the economic crisis (2009-2011)
Papaevangelou Vassiliki, Koutsoumbari Ioanna, Vintila Artemis, Klinaki Eleni, Zellos Aglaia, Achilleas Attilakos, Tsolia Maria and Kafetzis Dimitris
Author Affiliations
BMC Public Health 2014, 14:1192 doi:10.1186/1471-2458-14-1192
Published: 20 November 2014
Abstract (provisional)
Background
Childhood immunization has significantly reduced the incidence of vaccine preventable diseases. Parental mistrust over vaccine safety has been associated with vaccine refusal creating barriers on vaccine coverage. Recently, economic crisis has imposed additional impediment.
Methods
Study aim was to evaluate vaccine coverage among infants 2-24 months old in the Athens metropolitan area at the beginning of the economic crisis (2009-2011).
Results
Overall, 1,667 infants were enrolled (mean age 13 months). Less than 5% of parents admitted omitting or postponing vaccination secondary to their beliefs. Although vaccination coverage was acceptable for most vaccines, lower rates of immunization were found for some newer vaccines such as hepatitis A and rotavirus. Multiple regression analysis indicated that parental age, occupational, educational statuses and family size were independently associated with immunization coverage at 6 and 12 months. Interestingly, lack of insurance was not associated with missed vaccine doses.
Conclusion
Incomplete vaccination coverage was associated with socioeconomic factors. It becomes apparent, that reassessing vaccination priorities under the current economic situation may be needed.

Research article
Geographic information analysis and web-based geoportals to explore malnutrition in Sub-Saharan Africa: a systematic review of approaches
Sabrina Marx, Revati Phalkey, Clara Aranda, Jörn Profe, Rainer Sauerborn and Bernhard Höfle
Author Affiliations
BMC Public Health 2014, 14:1189 doi:10.1186/1471-2458-14-1189
Published: 20 November 2014
Abstract (provisional)
Background
Childhood malnutrition is a serious challenge in Sub-Saharan Africa (SSA) and a major underlying cause of death. It is the result of a dynamic and complex interaction between political, social, economic, environmental and other factors. As spatially oriented research has been established in health sciences in recent years, developments in Geographic Information Science (GIScience) provide beneficial tools to get an improved understanding of malnutrition.
Methods
In order to assess the current state of knowledge regarding the use of geoinformation analyses for exploring malnutrition in SSA, a systematic literature review of peer-reviewed literature is conducted using Scopus, ISI Web of Science and PubMed. As a supplement to the review, we carry on to investigate the establishment of web-based geoportals for providing freely accessible malnutrition geodata to a broad community. Based on these findings, we identify current limitations and discuss how new developments in GIScience might help to overcome impending barriers.
Results
563 articles are identified from the searches, from which a total of nine articles and eight geoportals meet inclusion criteria. The review suggests that the spatial dimension of malnutrition is analyzed most often at the regional and national level using geostatistical analysis methods. Therefore, heterogeneous geographic information at different spatial scales and from multiple sources is combined by applying geoinformation analysis methods such as spatial interpolation, aggregation and downscaling techniques. Geocoded malnutrition data from the Demographic and Health Survey Program are the most common information source to quantify the prevalence of malnutrition on a local scale and are frequently combined with regional data on climate, population, agriculture and/or infrastructure. Only aggregated geoinformation about malnutrition prevalence is freely accessible, mostly displayed via web map visualizations or downloadable map images. The lack of detailed geographic data at household and local level is a major limitation for an in-depth assessment of malnutrition and links to potential impact factors.
Conclusions
We propose that the combination of malnutrition-related studies with most recent GIScience developments such as crowd-sourced geodata collection, (web-based) interoperable spatial health data infrastructures as well as (dynamic) information fusion approaches are beneficial to deepen the understanding of this complex phenomenon.

Research article
Implementing effective hygiene promotion: lessons from the process evaluation of an intervention to promote handwashing with soap in rural India
Divya Rajaraman, Kiruba Sankar Varadharajan, Katie Greenland, Val Curtis, Raja Kumar, Wolf-Peter Schmidt, Robert Aunger and Adam Biran
Author Affiliations
BMC Public Health 2014, 14:1179 doi:10.1186/1471-2458-14-1179
Published: 19 November 2014
Abstract (provisional)
Background
An intervention trial of the ‘SuperAmma’ http://www.superamma.org/
village-level intervention to promote handwashing with soap (HWWS) in rural India demonstrated substantial increases in HWWS amongst the target population. We carried out a process evaluation to assess the implementation of the intervention and the evidence that it had changed the perceived benefits and social norms associated with HWWS. The evaluation also aimed to inform the design of a streamlined shorter intervention and estimate scale up costs.
Methods
Intervention implementation was observed in 7 villages. Semi-structured interviews were conducted with the implementation team, village leaders and representatives of the target population. A questionnaire survey was administered in 174 households in intervention villages and 171 households in control villages to assess exposure to intervention activities, recall of intervention components and evidence that the intervention had produced changes in perceptions that were consistent with the intervention core messages. Costs were estimated for the intervention as delivered, as well as for a hypothetical scale-up to 1,000 villages.
Results
We found that the intervention was largely acceptable to the target population, maintained high fidelity (after some starting problems), and resulted in a high level of exposure to most components. There was a high recall of most intervention activities and subjects in the intervention villages were more likely than those in control villages to cite reasons for HWWS that were in line with intervention messaging and to believe that HWWS was a social norm. There were no major differences between socio-economic and caste groups in exposure to intervention activities. Reducing the intervention from 4 to 2 contact days, in a scale up scenario, cut the estimated implementation cost from $2,293 to $1,097 per village.
Conclusions
The SuperAmma intervention is capable of achieving good reach across men and women of varied social and economic status, is affordable, and has the potential to be effective at scale provided that sufficient attention is given to ensuring the quality of intervention delivery.

Research article
Descriptive characterization of the 2010 cholera outbreak in Nigeria
Mahmood Muazu Dalhat1*, Aisha Nasiru Isa1, Patrick Nguku1, Sani-Gwarzo Nasir2, Katharina Urban1, Mohammed Abdulaziz1, Raymond Salanga Dankoli1, Peter Nsubuga3 and Gabriele Poggensee1
Author Affiliations
BMC Public Health 2014, 14:1167 doi:10.1186/1471-2458-14-1167
Published: 16 November 2014
Abstract
Background
In 2010, 18 States of Nigeria reported cholera outbreaks with a total of 41,787 cases including 1,716 deaths (case-fatality rate [CFR]: 4.1%). This exceeded the mean overall CFR of 2.4% reported in Africa from 2000–2005 and the WHO acceptable rate of 1%. We conducted a descriptive analysis of the 2010 cholera outbreak to determine its epidemiological and spatio-temporal characteristics.
Methods
We conducted retrospective analysis of line lists obtained from 10 of the 18 states that submitted line lists to the Federal Ministry of Health (FMOH). We described the outbreak by time, place and person and calculated the attack rates by state as well as the age- and sex-specific CFR from cholera cases for whom information on age, sex, place of residence, onset of symptoms and outcome were available.
Results
A total of 21,111 cases were reported with an overall attack rate and CFR of 47.8 cases /100,000 population and 5.1%, respectively. The CFR ranged in the states between 3.8% and 8.9%. The age-specific CFR was highest among individuals 65 years and above (14.6%). The epidemiological curve showed three peaks with increasing number of weekly reported cases. A geographical clustering of LGAs reporting cholera cases could be seen in all ten states. During the third peak which coincided with flooding in five states the majority of newly affected LGAs were situated next to LGAs with previously reported cholera cases, only few isolated outbreaks were seen.
Conclusion
Our study showed a cholera outbreak that grew in magnitude and spread to involve the whole northern part of the country. It also highlights challenges of suboptimal surveillance and response in developing countries as well as potential endemicity of cholera in the northern part of Nigeria. There is the need for a harmonized, coordinated approach to cholera outbreaks through effective surveillance and response with emphasis on training and motivating front line health workers towards timely detection, reporting and response. Findings from the report should be interpreted with caution due to the high number of cases with incomplete information, and lack of data from eight states.

Cost Effectiveness and Resource Allocation
(Accessed 22 November 2014)
http://www.resource-allocation.com/

Review
Health research priority setting in selected high income countries: a narrative review of methods used and recommendations for future practice
Jamie Bryant, Rob Sanson-Fisher, Justin Walsh and Jessica Stewart
Author Affiliations
Cost Effectiveness and Resource Allocation 2014, 12:23 doi:10.1186/1478-7547-12-23
Published: 18 November 2014
Abstract (provisional)
Research priority setting aims to gain consensus about areas where research effort will have wide benefits to society. While general principles for setting health research priorities have been suggested, there has been no critical review of the different approaches used. This review aims to: (i) examine methods, models and frameworks used to set health research priorities; (ii) identify barriers and facilitators to priority setting processes; and (iii) determine the outcomes of priority setting processes in relation to their objectives and impact on policy and practice. Medline, Cochrane, and PsycINFO databases were searched for relevant peer-reviewed studies published from 1990 to March 2012. A review of grey literature was also conducted. Priority setting exercises that aimed to develop population health and health services research priorities conducted in Australia, New Zealand, North America, Europe and the UK were included. Two authors extracted data from identified studies. Eleven diverse priority setting exercises across a range of health areas were identified. Strategies including calls for submission, stakeholder surveys, questionnaires, interviews, workshops, focus groups, roundtables, the Nominal Group and Delphi technique were used to generate research priorities. Nine priority setting exercises used a core steering or advisory group to oversee and supervise the priority setting process. None of the models conducted a systematic assessment of the outcomes of the priority setting processes, or assessed the impact of the generated priorities on policy or practice. A number of barriers and facilitators to undertaking research priority setting were identified. The methods used to undertake research priority setting should be selected based upon the context of the priority setting process and time and resource constraints. Ideally, priority setting should be overseen by a multi-disciplinary advisory group, involve a broad representation of stakeholders, utilise objective and clearly defined criteria for generating priorities, and be evaluated.

Globalization and Health
[Accessed 22 November 2014]
http://www.globalizationandhealth.com/

Debate
Contract Research Organizations (CROs) in China: integrating Chinese research and development capabilities for global drug innovation
Yun-Zhen Shi, Hao Hu* and Chunming Wang
Author Affiliations
State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
Globalization and Health 2014, 10:78 doi:10.1186/s12992-014-0078-4
Abstract
The significance of R&D capabilities of China has become increasingly important as an emerging force in the context of globalization of pharmaceutical research and development (R&D). While China has prospered in its R&D capability in the past decade, how to integrate the rising pharmaceutical R&D capability of China into the global development chain for innovative drugs remains challenging. For many multinational corporations and research organizations overseas, their attempt to integrate China’s pharmaceutical R&D capabilities into their own is always hindered by policy constraints and reluctance of local universities and pharmaceutical firms. In light of the situation, contract research organizations (CROs) in China have made great innovation in value proposition, value chain and value networking to be at a unique position to facilitate global and local R&D integration. Chinese CROs are now being considered as the essentially important and highly versatile integrator of local R&D capability for global drug discovery and innovation.

Journal of Global Infectious Diseases (JGID)
October-December 2014 Volume 6 | Issue 4 Page Nos. 139-198
http://www.jgid.org/currentissue.asp?sabs=n

SPECIAL ARTICLE
The emergence of Ebola as a global health security threat: From ‘lessons learned’ to coordinated multilateral containment efforts
Sarathi Kalra1, Dhanashree Kelkar2, Sagar C Galwankar2, Thomas J Papadimos3, Stanislaw P Stawicki1, Bonnie Arquilla4, Brian A Hoey1, Richard P Sharpe1, Donna Sabol1, Jeffrey A Jahre1
1 St Luke’s University Health Network, Bethlehem, Pennsylvania, USA
2 University of Florida, Jacksonville, Florida, USA
3 The Ohio State University College of Medicine, Columbus, Ohio, USA
4 SUNY Downstate Medical Center, Brooklyn, New York, USA
Abstract
First reported in remote villages of Africa in the 1970s, the Ebolavirus was originally believed to be transmitted to people from wild animals. Ebolavirus (EBOV) causes a severe, frequently fatal hemorrhagic syndrome in humans. Each outbreak of the Ebolavirus over the last three decades has perpetuated fear and economic turmoil among the local and regional populations in Africa. Until now it has been considered a tragic malady confined largely to the isolated regions of the African continent, but it is no longer so. The frequency of outbreaks has increased since the 1970s. The 2014 Ebola outbreak in Western Africa has been the most severe in history and was declared a public health emergency by the World Health Organization. Given the widespread use of modern transportation and global travel, the EBOV is now a risk to the entire Global Village, with intercontinental transmission only an airplane flight away. Clinically, symptoms typically appear after an incubation period of approximately 11 days. A flu-like syndrome can progress to full hemorrhagic fever with multiorgan failure, and frequently, death. Diagnosis is confirmed by detection of viral antigens or Ribonucleic acid (RNA) in the blood or other body fluids. Although historically the mortality of this infection exceeded 80%, modern medicine and public health measures have been able to lower this figure and reduce the impact of EBOV on individuals and communities. The treatment involves early, aggressive supportive care with rehydration. Core interventions, including contact tracing, preventive initiatives, active surveillance, effective isolation and quarantine procedures, and timely response to patients, are essential for a successful outbreak control. These measures, combined with public health education, point-of-care diagnostics, promising new vaccine and pharmaceutical efforts, and coordinated efforts of the international community, give new hope to the Global effort to eliminate Ebola as a public health threat. Here we present a review of EBOV infection in an effort to further educate medical and political communities on what the Ebolavirus disease entails, and what efforts are recommended to treat, isolate, and eventually eliminate it.

Journal of Health Care for the Poor and Underserved (JHCPU)
Volume 25, Number 4, November 2014
http://muse.jhu.edu/journals/journal_of_health_care_for_the_poor_and_underserved/toc/hpu.25.4.html

Commentary
Microfinance: Untapped Potential for Global Health
pp. 1718-1722
Ronak B. Patel

Report from the Field
An Integrated Chronic Disease Management Model: A Diagonal Approach to Health System Strengthening in South Africa
pp. 1723-1729
Ozayr Haroon Mahomed, Shaidah Asmall, Melvyn Freeman

Journal of Infectious Diseases
Volume 210 Issue 12 December 15, 2014
http://jid.oxfordjournals.org/content/current

Emergency Settings: Be Prepared to Vaccinate Persons Aged 15 and Over Against Measles
Reinhard Kaiser
Author Affiliations
Immunization, Vaccines, and Emergencies, WHO Regional Office for Africa, Inter-country Support Team, East and Southern Africa, Harare, Zimbabwe
[Initial text]
In their landmark article on measles prevention in emergency settings, Toole and colleagues recommended in 1989 that all children aged 6 months to 5 years should be immunized with measles vaccine at the time they enter an organized camp or settlement [1]. In 2000, Salama and colleagues documented substantial mortality during a famine emergency in Ethiopia, with measles and malnutrition as major contributing factors. In a retrospective study of mortality, measles alone, or in combination with wasting, accounted for 35 (22.0%) of 159 deaths among children younger than 5 years and for 12 (16.7%) of 72 deaths among children aged 5–14 years. The setting was a rural population without routine childhood immunization and exposure to natural measles virus infection [2]. The authors concluded that measles vaccination, in combination with vitamin A distribution, should be implemented in all types of complex emergencies. Vaccination coverage should be 90% and extended to children up to age 12–15 years [2]. A vaccination age range up to 14 years was included in the World Health Organization (WHO)/United Nations Children’s Fund (UNICEF) statement to reduce measles mortality in emergencies [3], and the revised SPHERE project guidelines [4]. However, since then, the discussion about target age groups has increasingly included the potential need to vaccinate adults. As early as 2000–2001, Kamugisha and colleagues documented 21% of measles cases that were 16 years and older in a major outbreak in Tanzanian camps with refugees from Burundi [5]. The authors concluded that in some emergency settings, achieving population immunity adequate to prevent virus transmission may require vaccinating persons older than 15 years, and the selection of …

Measles Outbreak Response Among Adolescent and Adult Somali Refugees Displaced by Famine in Kenya and Ethiopia, 2011
Carlos Navarro-Colorado1, Abdirahman Mahamud1,a, Ann Burton2,a, Christopher Haskew3, Gidraf K. Maina4, John B. Wagacha2, Jamal A. Ahmed5,a, Sharmila Shetty1,a, Susan Cookson1,
James L. Goodson1, Marian Schilperoord3 and Paul Spiegel3
Author Affiliations
1Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
2United Nations High Commissioner for Refugees (UNHCR), Nairobi, Kenya
3UNHCR, Geneva, Switzerland
4UNHCR, Addis Ababa, Ethiopia
5CDC, Nairobi, Kenya
Abstract
Background
The refugee complexes of Dadaab, Kenya, and Dollo-Ado, Ethiopia, experienced measles outbreaks during June–November 2011, following a large influx of refugees from Somalia.
Methods
Line-lists from health facilities were used to describe the outbreak in terms of age, sex, vaccination status, arrival date, attack rates (ARs), and case fatality ratios (CFRs) for each camp. Vaccination data and coverage surveys were reviewed.
Results
In Dadaab, 1370 measles cases and 32 deaths (CFR, 2.3%) were reported. A total of 821 cases (60.1%) were aged ≥15 years, 906 (82.1%) arrived to the camps in 2011, and 1027 (79.6%) were unvaccinated. Camp-specific ARs ranged from 212 to 506 cases per 100 000 people. In Dollo-Ado, 407 cases and 23 deaths (CFR, 5.7%) were reported. Adults aged ≥15 years represented 178 cases (43.7%) and 6 deaths (26.0%). Camp-specific ARs ranged from 21 to 1100 cases per 100 000 people. Immunization activities that were part of the outbreak responses initially targeted children aged 6 months to 14 years and were later expanded to include individuals up to 30 years of age.
Conclusions
The target age group for outbreak response–associated immunization activities at the start of the outbreaks was inconsistent with the numbers of cases among unvaccinated adolescents and adults in the new population. In displacement of populations from areas affected by measles outbreaks, health authorities should consider vaccinating adults in routine and outbreak response activities.

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 3 Issue 4 December 2014
http://jpids.oxfordjournals.org/content/current

Case-Control Studies to Assess the Effectiveness of Vaccines
Eugene D. Shapiro
Author Affiliations
Departments of Pediatrics, Epidemiology of Microbial Diseases, and Investigative Medicine, Yale University Schools of Medicine of Public Health and Graduate School of Arts and Sciences, New Haven, Connecticut
Extract
Before a vaccine is approved for general use, its protective efficacy must be demonstrated, usually in a double-blind, randomized clinical trial, the gold standard for scientific validity [1]. Randomization assures lack of bias in allocation of the exposure (vaccine), whereas blinding assures lack of bias in ascertainment of the outcome (infection). Nevertheless, there are a number of disadvantages, both practical and scientific, to randomized clinical trials to assess the efficacy of vaccines [2]. Because large samples and relatively prolonged follow-up may be necessary for adequate statistical power, these studies are extremely expensive. To limit costs, they often are conducted in select populations with an unusually high incidence of the infection of interest. These and other factors, such as the carefully controlled conditions of an experimental study, may lead to questions about the generalizability of the results of such trials to target populations that differ from that in which the trial was conducted. In addition, because clinical trials of experimental vaccines usually are conducted for only a relatively short period, the efficacy of the vaccine over time rarely is assessed…

Vaccination Rates for Measles, Mumps, Rubella, and Influenza Among Children Presenting to a Pediatric Emergency Department in New York City
Philip Zachariah1,2, Amanda Posner1, Melissa S. Stockwell1,2,3, Peter S. Dayan1, F. Meredith Sonnett1, Philip L. Graham1,2,4,5 and Lisa Saiman2,4
Author Affiliations
1Department of Pediatrics, Columbia University Medical Center, and
2Morgan Stanley Children’s Hospital of New York–Presbyterian, Columbia University Medical Center, New York
3Department of Population and Family Health, Columbia University Mailman School of Public Health, New York, New York
4Department of Infection Prevention and Control
5Division of Quality and Patient Safety, New York–Presbyterian Hospital, New York
Abstract
We compared measles, mumps, rubella (MMR), and influenza vaccination rates of children presenting to a Pediatric Emergency Department (PED) in New York City with rates from national assessments. MMR and influenza vaccination rates in this PED population were generally comparable to community rates, but lower than Healthy People 2020 targets.

The Lancet
Nov 22, 2014 Volume 384 Number 9957 p1821 – 1900
http://www.thelancet.com/journals/lancet/issue/current

Ethical considerations of experimental interventions in the Ebola outbreak
Dr Annette Rid MD a, Prof Ezekiel J Emanuel MD b
[Free full text]
Background
The outbreak of Ebola virus raging in west Africa is special in two respects. First, with more than 2100 infections and 1100 deaths,1 it has already become the most severe and largest documented Ebola outbreak. It is also occurring in some of the world’s least developed countries,2 and is therefore extremely complex to address. Second, experimental interventions that are still in the preclinical trial phase—and hence untested in human beings—were first given to health-care workers from high-income countries, focusing extensive attention and controversy on investigational treatments and vaccines for Ebola.3—5
The rapidly evolving situation raises three fundamental questions: how much emphasis should the international community place on experimental interventions in response to the Ebola epidemic; what are the ethical considerations if experimental treatments or vaccines are deployed; and if any interventions prove safe and effective, how can they be made more widely available?…

For debate: a new wave in public health improvement
Sally C Davies MBChB a, Eleanor Winpenny PhD b, Sarah Ball PhD b, Tom Fowler PhD a c d, Jennifer Rubin PhD b, Dr Ellen Nolte PhD b
Summary
The rising burden of chronic disease poses a challenge for all public health systems and requires innovative approaches to effectively improve population health. Persisting inequalities in health are of particular concern. Disadvantage because of education, income, or social position is associated with a larger burden of disease and, in particular, multimorbidity. Although much has been achieved to enhance population health, challenges remain, and approaches need to be revisited. In this paper, we join the debate about how a new wave of public health improvement might look. We start from the premise that population health improvement is conditional on a health-promoting societal context. It is characterised by a culture in which healthy behaviours are the norm, and in which the institutional, social, and physical environment support this mindset. Achievement of this ambition will require a positive, holistic, eclectic, and collaborative effort, involving a broad range of stakeholders. We emphasise three mechanisms: maximisation of the value of health and incentives for healthy behaviour; promotion of healthy choices as default; and minimisation of factors that create a culture and environment which promote unhealthy behaviour. We give examples of how these mechanisms might be achieved.

New England Journal of Medicine
November 20, 2014 Vol. 371 No. 21
http://www.nejm.org/toc/nejm/medical-journal

History of Medicine: A Half-Century of Prevention — The Advisory Committee on Immunization Practices
J.L. Schwartz and A. Mahmoud
Free Full Text/Audio

Editorial
Ebola and Quarantine
Jeffrey M. Drazen, M.D., Rupa Kanapathipillai, M.B., B.S., M.P.H., D.T.M.&H., Edward W. Campion, M.D., Eric J. Rubin, M.D., Ph.D., Scott M. Hammer, M.D., Stephen Morrissey, Ph.D., and Lindsey R. Baden, M.D.
N Engl J Med 2014; 371:2029-2030 November 20, 2014 DOI: 10.1056/NEJMe1413139
The governors of a number of states, including New York and New Jersey, recently imposed 21-day quarantines on health care workers returning to the United States from regions of the world where they may have cared for patients with Ebola virus disease. We understand their motivation for this policy — to protect the citizens of their states from contracting this often-fatal illness. This approach, however, is not scientifically based, is unfair and unwise, and will impede essential efforts to stop these awful outbreaks of Ebola disease at their source, which is the only satisfactory goal. The governors’ action is like driving a carpet tack with a sledgehammer: it gets the job done but overall is more destructive than beneficial.

Health care professionals treating patients with this illness have learned that transmission arises from contact with bodily fluids of a person who is symptomatic — that is, has a fever, vomiting, diarrhea, and malaise. We have very strong reason to believe that transmission occurs when the viral load in bodily fluids is high, on the order of millions of virions per microliter. This recognition has led to the dictum that an asymptomatic person is not contagious; field experience in West Africa has shown that conclusion to be valid. Therefore, an asymptomatic health care worker returning from treating patients with Ebola, even if he or she were infected, would not be contagious. Furthermore, we now know that fever precedes the contagious stage, allowing workers who are unknowingly infected to identify themselves before they become a threat to their community. This understanding is based on more than clinical observation: the sensitive blood polymerase-chain-reaction (PCR) test for Ebola is often negative on the day when fever or other symptoms begin and only becomes reliably positive 2 to 3 days after symptom onset. This point is supported by the fact that of the nurses caring for Thomas Eric Duncan, the man who died from Ebola virus disease in Texas in October, only those who cared for him at the end of his life, when the number of virions he was shedding was likely to be very high, became infected. Notably, Duncan’s family members who were living in the same household for days as he was at the start of his illness did not become infected.

A cynic would say that all these “facts” are derived from observation and that it pays to be 100% safe and to isolate anyone with a remote chance of carrying the virus. What harm can that approach do besides inconveniencing a few health care workers? We strongly disagree. Hundreds of years of experience show that to stop an epidemic of this type requires controlling it at its source. Médecins sans Frontières, the World Health Organization, the U.S. Agency for International Development (USAID), and many other organizations say we need tens of thousands of additional volunteers to control the epidemic. We are far short of that goal, so the need for workers on the ground is great. These responsible, skilled health care workers who are risking their lives to help others are also helping by stemming the epidemic at its source. If we add barriers making it harder for volunteers to return to their community, we are hurting ourselves.

In the end, the calculus is simple, and we think the governors have it wrong. The health care workers returning from West Africa have been helping others and helping to end the epidemic that has killed thousands of people and scared millions. At this point the public does need assurances that returning workers will have their temperatures and health status monitored according to a set, documented protocol. In the unlikely event that they become febrile, they can follow the example of Craig Spencer, the physician from New York who alerted public health officials of his fever. As we continue to learn more about this virus, its transmission, and associated illness, we must continue to revisit our approach to its control and treatment. We should be guided by the science and not the tremendous fear that this virus evokes.

We should be honoring, not quarantining, health care workers who put their lives at risk not only to save people suffering from Ebola virus disease in West Africa but also to help achieve source control, bringing the world closer to stopping the spread of this killer epidemic.

PLoS One
[Accessed 22 November 2014]
http://www.plosone.org/

Research Article
Molecular Confirmation of Bacillus Calmette Guerin Vaccine Related Adverse Events among Saudi Arabian Children
Sahal Al-Hajoj mail, Ziad Memish, Naila Abuljadayel, Raafat AlHakeem, Fahad AlRabiah, Bright Varghese
Published: November 19, 2014
DOI: 10.1371/journal.pone.0113472
Abstract
Background
Bacillus Calmette Guerin (BCG) is the only available vaccine for tuberculosis (TB). Low grade complications in healthy recipients and disseminated vaccine associated complications among immuno-suppressed individuals were noticed globally after administration. Recently a series of clinically suspected BCG associated suppurative and non-suppurative lymphadenitis cases were reported from different regions of Saudi Arabia. However a molecular confirmative analysis was lacking to prove these claims.
Methodology
During 2009–2010, 42 Mycobacterium bovis BCG suspected clinical isolates from children diagnosed with suppurative lymphadenitis from different provinces of the country were collected and subjected to 24 loci based MIRU-VNTR typing, spoligotyping and first line anti-TB drugs susceptibility testing.
Principal Findings
Of the total 42 cases, 41 (97.6%) were Saudi nationals and particularly male (64.3%). Majority of the cases were aged below 6 months (83.3%) with a median of age 4 months. All the enrolled subjects showed left axillary mass which suppurated in a median of 4 months after vaccination. Among the study subjects, 1 (2.4%) case was reactive to HIV antigen and 2 (4.8%) case had severe combined immunodeficiency. Genotyping results showed that, 41 (97.6%) isolates were identical to the vaccine strain Danish 1331 and one to Tokyo 172-1. Phylogenetic analysis revealed all the Danish 1331 isolates in a single cluster.
Conclusion
Elevated proportion of suppurative lymphadenitis caused by M. bovis BCG reported in the country recently is majorly related to the vaccine strain Danish 1331. However lack of nationwide data on real magnitude of BCG related adverse events warrants population centric, long term future studies.

PLoS One
[Accessed 22 November 2014]
http://www.plosone.org/

Research Article
Immunization of Epidemics in Multiplex Networks
Dawei Zhao mail, Lianhai Wang, Shudong Li, Zhen Wang mail, Lin Wang mail, Bo Gao
Published: November 17, 2014
DOI: 10.1371/journal.pone.0112018
Abstract
Up to now, immunization of disease propagation has attracted great attention in both theoretical and experimental researches. However, vast majority of existing achievements are limited to the simple assumption of single layer networked population, which seems obviously inconsistent with recent development of complex network theory: each node could possess multiple roles in different topology connections. Inspired by this fact, we here propose the immunization strategies on multiplex networks, including multiplex node-based random (targeted) immunization and layer node-based random (targeted) immunization. With the theory of generating function, theoretical analysis is developed to calculate the immunization threshold, which is regarded as the most critical index for the effectiveness of addressed immunization strategies. Interestingly, both types of random immunization strategies show more efficiency in controlling disease spreading on multiplex Erdös-Rényi (ER) random networks; while targeted immunization strategies provide better protection on multiplex scale-free (SF) networks.

Risk Analysis
October 2014 Volume 34, Issue 10 Pages 1775–1967
http://onlinelibrary.wiley.com/doi/10.1111/risa.2014.34.issue-9/issuetoc

Original Research Article
Near-Misses and Future Disaster Preparedness
Robin L. Dillon1,*, Catherine H. Tinsley1 and William J. Burns2,3
Article first published online: 28 APR 2014
DOI: 10.1111/risa.12209
Abstract
Disasters garner attention when they occur, and organizations commonly extract valuable lessons from visible failures, adopting new behaviors in response. For example, the United States saw numerous security policy changes following the September 11 terrorist attacks and emergency management and shelter policy changes following Hurricane Katrina. But what about those events that occur that fall short of disaster? Research that examines prior hazard experience shows that this experience can be a mixed blessing. Prior experience can stimulate protective measures, but sometimes prior experience can deceive people into feeling an unwarranted sense of safety. This research focuses on how people interpret near-miss experiences. We demonstrate that when near-misses are interpreted as disasters that did not occur and thus provide the perception that the system is resilient to the hazard, people illegitimately underestimate the danger of subsequent hazardous situations and make riskier decisions. On the other hand, if near-misses can be recognized and interpreted as disasters that almost happened and thus provide the perception that the system is vulnerable to the hazard, this will counter the basic “near-miss” effect and encourage mitigation. In this article, we use these distinctions between resilient and vulnerable near-misses to examine how people come to define an event as either a resilient or vulnerable near-miss, as well as how this interpretation influences their perceptions of risk and their future preparedness behavior. Our contribution is in highlighting the critical role that people’s interpretation of the prior experience has on their subsequent behavior and in measuring what shapes this interpretation.

Science
21 November 2014 vol 346, issue 6212, pages 885-1028
http://www.sciencemag.org/current.dtl

Feature
Saving lives without new drugs
Jon Cohen
Many people treated for Ebola in West Africa have received bare-bones care in overwhelmed facilities that had few resources, contributing to a case fatality rate (CFR) of about 70%. Of the 20 patients treated in the United States and Europe, only five have died, a CRF of 25%, and the ones who did not recover tended to begin their care at the latest stages of disease. Now, a push is on for what’s dubbed Maximum Use of Supportive Care (MUST), which would offer Ebola patients in West Africa the basic life-saving interventions common in wealthier countries. MUST includes intravenous fluids to combat dehydration; balancing of electrolytes; nasogastric tubes for feedings; and medicines to counter diarrhea, vomiting, and secondary infections like bacterial sepsis and malaria. Estimates suggest that MUST would cost no more than $600 per patient.

Report
Strategies for containing Ebola in West Africa
Abhishek Pandey1,*, Katherine E. Atkins1,2,*, Jan Medlock3, Natasha Wenzel1, Jeffrey P. Townsend4, James E. Childs5, Tolbert G. Nyenswah6, Martial L. Ndeffo-Mbah1, Alison P. Galvani1,5,
Author Affiliations
1Center for Infectious Disease Modeling and Analysis, Yale School of Public Health, New Haven, CT, USA.
2Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
3Department of Biomedical Sciences, Oregon State University, Corvallis, OR, USA.
4Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
5Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA.
6Ministry of Health and Social Welfare, Monrovia, Liberia.
Abstract
The ongoing Ebola outbreak poses an alarming risk to the countries of West Africa and beyond. To assess the effectiveness of containment strategies, we developed a stochastic model of Ebola transmission between and within the general community, hospitals, and funerals, calibrated to incidence data from Liberia. We find that a combined approach of case isolation, contact-tracing with quarantine, and sanitary funeral practices must be implemented with utmost urgency in order to reverse the growth of the outbreak. As of 19 September, under status quo, our model predicts that the epidemic will continue to spread, generating a predicted 224 (134 to 358) daily cases by 1 December, 280 (184 to 441) by 15 December, and 348 (249 to 545) by 30 December.

Report
Antibody landscapes after influenza virus infection or vaccination
J. M. Fonville1,2,3,*, S. H. Wilks1,2,*, S. L. James1,2, A. Fox4, M. Ventresca1, , M. Aban5,
L. Xue5, T. C. Jones1,2, Le N. M. H.4, Pham Q. T.6, Tran N. D.6, Y. Wong7, A. Mosterin1,2,
L. C. Katzelnick1,2, D. Labonte8, Le T. T.6, G. van der Net3, E. Skepner1,2, C. A. Russell2,9, T. D. Kaplan10, G. F. Rimmelzwaan3, N. Masurel3, J. C. de Jong3, A. Palache11, W. E. P. Beyer3, Le Q. M.6, Nguyen T. H.6, H. F. L. Wertheim4,12, A. C. Hurt5,13, A. D. M. E. sterhaus3,
I. G. Barr5, R. A. M. Fouchier3, P. W. Horby4,12, D. J. Smith1,2,3,
Author Affiliations
1Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK.
2World Health Organization (WHO) Collaborating Center for Modeling, Evolution, and Control of Emerging Infectious Diseases, Cambridge CB2 3EJ, UK.
3Department of Viroscience, Erasmus Medical Center, Rotterdam 3015 CE, Netherlands.
4Oxford University Clinical Research Unit and Wellcome Trust Major Overseas Programme, Hanoi, Vietnam.
5WHO Collaborating Centre for Reference and Research on Influenza, Victorian Infectious Diseases Reference Laboratory at the Peter Doherty Institute for Infection and Immunity, Melbourne VIC 3000, Australia.
6National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
7Oxford University Museum of Natural History, Oxford OX1 3PW, UK.
8Insect Biomechanics Group, Department of Zoology, University of Cambridge, Cambridge CB2 3EJ, UK.
9Department of Veterinary Medicine, University of Cambridge, Cambridge CB3 0ES, UK.
10bobblewire.com, Saint Louis, MO 63112, USA.
11Abbott Laboratories, Weesp 1380 DA, Netherlands.
12Nuffield Department of Clinical Medicine, Centre for Tropical Medicine, University of Oxford, Oxford OX3 7BN, UK.
13Melbourne School of Population and Global Health, University of Melbourne, Parkville VIC 3010, Australia.
Abstract
We introduce the antibody landscape, a method for the quantitative analysis of antibody-mediated immunity to antigenically variable pthogens, achieved by accounting for antigenic variation among pathogen strains. We generated antibody landscapes to study immune profiles covering 43 years of influenza A/H3N2 virus evolution for 69 individuals monitored for infection over 6 years and for 225 individuals pre- and postvaccination. Upon infection and vaccination, titers increased broadly, including previously encountered viruses far beyond the extent of cross-reactivity observed after a primary infection. We explored implications for vaccination and found that the use of an antigenically advanced virus had the dual benefit of inducing antibodies against both advanced and previous antigenic clusters. These results indicate that preemptive vaccine updates may improve influenza vaccine efficacy in previously exposed individuals.

Vaccine
Volume 32, Issue 51, Pages 6867-7032 (5 December 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/51

A systematic literature review of missed opportunities for immunization in low- and middle-income countries
Review Article
Pages 6870-6879
Shruti Sridhar, Nadira Maleq, Elise Guillermet, Anais Colombini, Bradford D. Gessner
Abstract
Background
Missed opportunities for immunization (MOIs) may contribute to low coverage in diverse settings, including developing countries.
Methods
We conducted a systematic literature review on MOIs among children and women of childbearing age from 1991 to the present in low- and middle-income countries. We searched multiple databases and the references of retrieved articles. Meta-analysis provided a pooled prevalence estimate and both univariate and multivariate meta-regression analysis was done to explore heterogeneity of results across studies.
Results
We found 61 data points from 45 studies involving 41,310 participants. Of the 45 studies, 41 involved children and 10 involved women. The pooled MOI prevalence was 32.2% (95% CI: 26.8–37.7) among children – with no change during the study period – and 46.9% (95% CI: 29.7–64.0%) among women of child-bearing age. The prevalence varied by region and study methodology but these two variables together accounted for only 12% of study heterogeneity. Among 352 identified reasons for MOIs, the most common categories were health care practices, false contraindications, logistic issues related to vaccines, and organizational limitations, which did not vary by time or geographic region.
Conclusions
MOI prevalence was high in low- and middle-income settings but the large number of identified reasons precludes standardized solutions.

Vaccine
Volume 32, Issue 51, Pages 6867-7032 (5 December 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/51

Measles – The epidemiology of elimination
Review Article
Pages 6880-6883
David N. Durrheim, Natasha S. Crowcroft, Peter M. Strebel
Abstract
Tremendous progress has been made globally to reduce the contribution of measles to the burden of childhood deaths and measles cases have dramatically decreased with increased two dose measles-containing vaccine coverage. As a result the Global Vaccine Action Plan, endorsed by the World Health Assembly, has targeted measles elimination in at least five of the six World Health Organisation Regions by 2020. This is an ambitious goal, since measles control requires the highest immunisation coverage of any vaccine preventable disease, which means that the health system must be able to reach every community. Further, while measles remains endemic in any country, importations will result in local transmission and outbreaks in countries and Regions that have interrupted local endemic measles circulation.
One of the lines of evidence that countries and Regions must address to confirm measles elimination is a detailed description of measles epidemiology over an extended period. This information is incredibly valuable as predictable epidemiological patterns emerge as measles elimination is approached and achieved. These critical features, including the source, size and duration of outbreaks, the seasonality and age-distribution of cases, genotyping pointers and effective reproduction rate estimates, are discussed with illustrative examples from the Region of the Americas, which eliminated measles in 2002, and the Western Pacific Region, which has established a Regional Verification Commission to review progress towards elimination in all member countries.

Vaccine
Volume 32, Issue 51, Pages 6867-7032 (5 December 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/51

Are influenza-associated morbidity and mortality estimates for those ≥65 in statistical databases accurate, and an appropriate test of influenza vaccine effectiveness?
Review Article
Pages 6884-6901
Roger E. Thomas
Abstract
Purposes
To assess the accuracy of estimates using statistical databases of influenza-associated morbidity and mortality, and precisely measure influenza vaccine effectiveness.
Principal results
Laboratory testing of influenza is incomplete. Death certificates under-report influenza. Statistical database models are used as an alternative to randomised controlled trials (RCTs) to assess influenza vaccine effectiveness. Evidence of the accuracy of influenza morbidity and mortality estimates was sought from: (1) Studies comparing statistical models. For four studies Poisson and ARIMA models produced higher estimates than Serfling, and Serfling higher than GLM. Which model is more accurate is unknown. (2) Studies controlling confounders. Fourteen studies mostly controlled one confounder (one controlled comorbidities), and limited control of confounders limits accuracy.
Evidence for vaccine effectiveness was sought from
(1) Studies of regions with increasing vaccination rates. Of five studies two controlled for confounders and one found a positive vaccination effect. Three studies did not control confounders and two found no effect of vaccination. (2) Studies controlling multiple confounders. Of thirteen studies only two found a positive vaccine effect and no mortality differences between vaccinees and non-vaccinees in non-influenza seasons, showing confounders were controlled.
Key problems are insufficient testing for influenza, using influenza-like illness, heterogeneity of seasonal and pandemic influenza, population aging, and incomplete confounder control (co-morbidities, frailty, vaccination history) and failure to demonstrate control of confounders by proving no mortality differences between vaccinees and non-vaccinees in non-influenza seasons.
Major conclusions
Improving model accuracy requires proof of no mortality differences in pre-influenza periods between the vaccinated and non-vaccinated groups, and reduction in influenza morbidity and mortality in seasons with a good vaccine match, more virulent strains, in the younger elderly with less immune senescence, and specific outcomes (laboratory-confirmed outcomes, pneumonia deaths).
Proving influenza vaccine effectiveness requires appropriately powered RCTs, testing participants with RT-PCR tests, and comprehensively monitoring morbidity and mortality.

Vaccine
Volume 32, Issue 51, Pages 6867-7032 (5 December 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/51

Progress towards measles elimination in Singapore
Original Research Article
Pages 6927-6933
Hanley J. Ho, Constance Low, Li Wei Ang, Jeffery L. Cutter, Joanne Tay, Kwai Peng Chan, Peng Lim Ooi, Koh Cheng Thoon, Kee Tai Goh
Abstract
Objective
We describe the epidemiological trends of measles in Singapore in relation to its progress towards measles elimination and identify gaps in fulfilling the World Health Organization Western Pacific Regional Office regional measles elimination criteria.
Methods
Epidemiological data on measles maintained by the Communicable Diseases Division, Ministry of Health from 1981 to 2012 were collated and analysed. Data on measles vaccination coverage were obtained from the National Immunization Registry and School Health Services, Health Promotion Board. To assess the seroprevalence of the population, the findings of periodic seroepidemiological surveys on measles were traced and reviewed.
Findings
With the successful implementation of the National Childhood Immunization Programme using the monovalent measles vaccine, measles incidence declined from 88.5 cases per 100,000 in 1984 to 6.9 per 100,000 in 1991. Resurgences were observed in 1992, 1993 and 1997. A ‘catch-up’ vaccination programme using the trivalent measles, mumps and rubella (MMR) vaccine was conducted in 1997, followed by introduction of the two-dose vaccination schedule in January 1998. Measles incidence subsequently declined sharply to 2.9 per 100,000 in 1998. Vaccination coverage was maintained at 95% for the first dose and 92–94% for the second dose. Seroprevalence surveys showed seropositivity for measles IgG antibodies in over 95% of adults in 2004, and in 83.1% of children aged 1–17 years in 2008–2010. Sporadic cases with occasional clusters of two or more cases continued to occur among the unvaccinated population, especially children aged below 4 years. The predominant measles virus genotype has shifted from D9 to the B3 and G3 genotypes, which are endemic in neighbouring countries.
Conclusion
Singapore has made good progress towards the elimination of endemic measles. To further eliminate sporadic cases of measles, the national immunisation schedule has recently been amended to vaccinate children with 2 doses of MMR vaccine before 2 years of age.

Vaccine
Volume 32, Issue 51, Pages 6867-7032 (5 December 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/51

The intention to get vaccinated against influenza and actual vaccination uptake of Dutch healthcare personnel
Original Research Article
Pages 6986-6991
Birthe A. Lehmann, Robert A.C. Ruiter, Gretchen Chapman, Gerjo Kok
Abstract
Health Authorities recommend annual vaccination of healthcare personnel (HCP) against influenza to protect vulnerable patients. Nevertheless, vaccination rates have been low among European HCP. Here we report on a longitudinal survey study to identify social cognitive predictors of the motivation to obtain influenza vaccination, and to test whether intention is a good predictor of actual vaccination behaviour. Dutch HCP (N = 1370) were invited to participate in a survey (baseline). To link intention to behaviour, participants who completed the first survey (N = 556) were sent a second survey after vaccinations were offered (follow-up). Multinominal regression analysis showed that HCP with a positive attitude and a higher frequency of past vaccinations were more likely to have a high intention to get vaccinated. A negative attitude, high feelings of autonomy in the decision whether to get vaccinated, a preference of inaction over vaccination, a lesser sense of personal responsibility, and high self-protection motives increased the probability of no intention to get vaccinated. Social cognitive predictors were identified that explain the intention to get vaccinated against influenza of HCP, which in turn proved to be a good predictor of behaviour. Future interventions should focus on these variables to increase vaccination coverage rates.

Vaccine
Volume 32, Issue 51, Pages 6867-7032 (5 December 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/51

Pertussis vaccine for adults: Knowledge, attitudes, and vaccine receipt among adults with children in the household
Original Research Article
Pages 7000-7004
Manika Suryadevara, Cynthia A. Bonville, Donald A. Cibula, Matthew Valente, Andrew Handel, James R. Domachowse, Joseph B. Domachowske
Abstract
Background
Pertussis is a highly contagious vaccine preventable disease resulting in significant infant morbidity and mortality. Despite the recommendations for pertussis vaccine (Tdap) in adults, coverage rates in this age group remain suboptimal. We sought to determine factors associated with Tdap receipt among adults with children in the household who live in central New York.
Methods
The study team surveyed Tdap immunization status of adults who accessed medical services for their children provided by Golisano Children’s Hospital, Syracuse, New York. Adults who did not know their Tdap vaccine status were excluded. Each participant was asked a standard set of questions to determine factors associated with Tdap receipt. Logistic regression was used to calculate simple and adjusted odds ratios for Tdap receipt in relation to adults’ demographic characteristics, knowledge of Tdap and physician recommendations.
Results
Eight hundred twenty four participants were included in this study; 34% had received Tdap in the past 5 years; 58% reported that their provider or child’s pediatrician recommended adult Tdap vaccination. Tdap receipt was associated with knowing the symptoms of pertussis infection, female gender, younger age, and provider recommendation (p < 0.05). Participants whose provider recommended Tdap vaccine were 24.6 times more likely to receive vaccine when compared to those whose providers did not recommend vaccine (95% CI: 16.3, 37.2, p < 0.05).
Conclusion
Tdap coverage rates are low among this study population, with provider recommendation most strongly associated with Tdap receipt. Future steps to improve vaccine coverage should include both increasing community awareness and determining barriers to provider recommendation.

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

British Journal of Dermatology
November 2014 Volume 171, Issue 5 Pages i–i, 921–1276, e95–e99
http://onlinelibrary.wiley.com/doi/10.1111/bjd.2014.171.issue-5/issuetoc
Accepted Article
Poor adherence to vaccination guidelines in dermatology patients on immunosuppressive therapies: an issue in need of address
M. Sadlier1,*, C. Sadlier2,3, A. Alani1, K. Ahmad1, C. Bergin2,3 and B. Ramsay1
DOI: 10.1111/bjd.13543
Abstract
Patients with skin disease are increasingly prescribed systemic immunosuppressive therapies which can increase their susceptibility to infection.1,2 Many of the infections encountered are preventable through comprehensive pre-immunosuppression assessment, pro-active treatment of any identified latent infection, and administration of recommended vaccinations. Despite the availability of both specialty specific consensus immunisation guidelines3,4 as well as general guidelines for the immunocompromised individual,5 which advise routine administration of the influenza and pneumococcal vaccinations to patients taking immunosuppressive therapies as outlined in Table 1, adherence to these recommendations and provision of vaccinations is often poor. This is of concern as influenza infection is responsible for considerable morbidity and mortality annually, and pneumococcal infection is one of the leading causes of death worldwide.

PLoS Pathogens
10(11): e1004438. doi:10.1371/journal.ppat.1004438
War and Infectious Diseases: Challenges of the Syrian Civil War
Sima L. Sharara, Souha S. Kanj mail
Published: November 13, 2014
DOI: 10.1371/journal.ppat.1004438
Overview
Syria’s ongoing three-year civil war has displaced 6.5 million Syrians, left hundreds of thousands wounded or killed by violence, and created a vacuum in basic infrastructures that will reverberate throughout the region for years to come. Beyond such devastation, the civil war has introduced epidemics of infections that have spread through vulnerable populations in Syria and neighboring countries. In this article, we discuss the growing epidemics of poliomyelitis, measles, and cutaneous leishmaniasis in Syria and the region to examine the impact of conditions of war on the spread of infectious diseases in a public health emergency of global concern.

Special Focus Newsletters
RotaFlash – November 21, 2014
Lead Story
Rotavirus infections and related hospitalizations and deaths plummet in Brazil
New studies show remarkable evidence of rotavirus vaccine impact and effectiveness in Brazil 8 years after introduction of vaccines

Media/Policy Watch

AP (Associated Press)
Accessed 22 November 2014
http://www.ap.org/

WHO chief promises transparency in Ebola review
Associated Press | 19 November 2014
ROME (AP) — The head of the World Health Organization refused Wednesday to respond to criticism about the U.N. agency’s performance in containing the Ebola outbreak, saying the focus now should be on helping countries contain it.
Dr. Margaret Chan said the agency would review how the whole world — and the WHO in particular — managed the outbreak “and there will be time for sharing information in a transparent and accountable manner.”
“But at this point in time, it is important for us to focus our entire energy and attention to help countries who are being affected to get the job done,” she said…

AP IMPACT: ‘Vaccine court’ keeps claimants waiting
Associated Press | 18 November 2014
WASHINGTON (AP) — A system Congress established to speed help to Americans harmed by vaccines has instead heaped additional suffering on thousands of families, The Associated Press has found.
The premise was simple: quickly and generously pay for medical care in the rare cases when a shot to prevent a sickness such as flu or measles instead is the likely cause of serious health complications. But the system is not working as intended.
The AP read hundreds of decisions, conducted more than 100 interviews, and analyzed a database of more than 14,500 cases filed in a special vaccine court. That database was current as of January 2013; the government has refused to release an updated version since…

Council on Foreign Relations
http://www.cfr.org/
Accessed 22 November 2014
Book
Ebola: Story of an Outbreak
by Laurie Garrett November 17, 2014
Laurie Garrett offers a masterful account of the 1995 Ebola outbreak in Zaire, and argues these lessons learned must be applied to solve the Ebola crisis of 2014 and to understand one of mankind’s most mysterious, malicious scourges.

Forbes
http://www.forbes.com/
Accessed 22 November 2014
Ebola Lessons And The Way Forward
Bill Frist, Contributor Nov 21, 2014
Thankfully—and appropriately—the panic surrounding Ebola in the United States has waned over the past weeks. But the calm doesn’t mean it’s time to move on, though the news cycle may have. All major crises can be teachable moments and now is the time to carefully consider our response to the Ebola outbreak and what we can learn to prevent these types of outbreaks in the future.

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

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Associate Faculty, Division of Medical Ethics, NYU Medical School

WHO warns that progress towards eliminating measles has stalled
2015 targets will not be met
News release
[Excerpt]
13 November 2014 ¦ GENEVA – WHO warned today that progress towards the elimination of measles has stalled. The number of deaths from measles increased from an estimated 122 000 in 2012 to 145 700 in 2013, according to new data published in the WHO Weekly Epidemiological Report and the Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report. The estimated number of measles deaths in 2013 represents a 75% decline in mortality since 2000, significantly below the target of a 95% reduction in deaths between 2000 and 2015.
“Poor progress in increasing measles vaccination coverage has resulted in large outbreaks of this highly contagious disease, throwing the 2015 elimination targets off-track,” said Dr Peter Strebel from the WHO Department of Immunization, Vaccines, and Biologicals.
“Countries urgently need to prioritize maintaining and improving immunization coverage. Failure to reverse this alarming trend could jeopardize the momentum generated by a decade of achievements in reducing measles mortality.”
Member States of all 6 WHO Regions have set goals for measles elimination. “Countries urgently need to prioritize maintaining and improving immunization coverage. Failure to reverse this alarming trend could jeopardize the momentum generated by a decade of achievements in reducing measles mortality,” said Dr Strebel.
Meeting these goals on time is one of the 6 goals of the Global Vaccine Action Plan, endorsed by all Member States at the World Health Assembly in 2012. Despite being vaccine-preventable, measles is still an important cause of death and disability among children worldwide. Strong efforts are needed to maintain the current level of control and to continue reducing the number of cases and deaths. WHO and its partners in the Measles & Rubella Initiative have been warning for a number of years that the disease has the potential to rebound if vaccination and surveillance efforts are not maintained and strengthened.
While the increase in the disease in 2013 was in large part due to outbreaks in China, the Democratic Republic of the Congo, and Nigeria, sizeable outbreaks were also reported in other parts of the world. Progress is stalled in the WHO Eastern Mediterranean region, where weak health systems and conflict and population displacement have hampered vaccination efforts. Meanwhile, the European region has seen measles re-emerge with outbreaks in a number of countries including Georgia, Turkey and Ukraine, and renewed high-level political commitment is needed to reverse this trend…

The Weekly Epidemiological Record (WER) for 14 November 2014, vol. 89, 46 (pp. 509–516) includes:
:: Global progress towards regional measles elimination, worldwide, 2000–2013
http://www.who.int/entity/wer/2014/wer8946.pdf?ua=1

POLIO [to 15 November 2014]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 12 November 2014
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: In Madagascar, a circulating vaccine-derived poliovirus type 1 (cVDPV1) has been confirmed. The virus was isolated from one case of acute flaccid paralysis (AFP) with onset of paralysis on 29 September, and from three healthy contacts. An estimated more than 25% of children remain under-immunized against polio in the country. Madagascar was previously affected by a cVDPV2 outbreak in 2001/2002 (resulting in five cases) and in 2005 (resulting in three cases). Emergency outbreak response is being finalized, with campaigns to be held in December and January.
:: It has been two years since the last case due to wild poliovirus type 3 (WPV3) was reported. WPV3 was last detected globally on 10 November 2012, in Yobe, Nigeria. In Asia, the last WPV3 was detected in April 2012, in Khyber Agency, Federally Administered Tribal Areas (FATA), Pakistan. All cases due to wild poliovirus in the past two years have been caused by wild poliovirus type 1 (WPV1). Wild poliovirus type 2 (WPV2) has not been detected since 1999
Pakistan
:: One new wild poliovirus type 1 (WPV1) case was reported in the past week, from Khyber, Federally Administered Tribal Areas (FATA). The total number of WPV1 cases in 2014 is now 236, compared to 59 at this time last year. The most recent WPV1 case had onset of paralysis on 20 October, from South Waziristan, FATA.
Horn of Africa
:: Following confirmation of two cases of circulating vaccine derived poliovirus type 2 (cVDPV2) in South Sudan last week, outbreak response is being finalized in the country. National Immunization Days (NIDs) were already implemented on 4 November, with further campaigns planned for December and January.

Poliovirus in South Sudan and Madagascar
Separate circulating vaccine-derived polioviruses confirmed in South Sudan and Madagascar
GAR- Disease outbreak news
14 November 2014
In separate and unrelated events, circulating vaccine-derived polioviruses (cVDPVs) have been confirmed in South Sudan and Madagascar.

South Sudan
In South Sudan, 2 cases due to cVDPV type 2 (cVDPV2) have been confirmed. The strains were isolated from 2 acute flaccid paralysis (AFP) cases in Unity state, with onset of paralysis on 9 September and 12 September 2014, respectively. In Unity state, as many as 33% of children remain under-immunized against poliovirus. Both cases are from an internally-displaced persons camp in Unity state. Unity state has been affected by civil unrest, leading to population displacements and declining vaccination coverage in most of the areas.
In 2014, South Sudan has been participating in regional Horn of Africa outbreak response, given the risk posed by an ongoing wild poliovirus type 1 (WPV1) outbreak affecting the region (with cases in 2014 in parts of Somalia and Ethiopia). Two National Immunization Days (NIDs) were conducted in April (with trivalent oral polio vaccine – OPV) and May (with bivalent OPV). In response to confirmation of the cVDPV2, NIDs were held on 4 November with trivalent OPV and further Subnational Immunization Days (SNID) covering the 3 states with civil unrest (Unity, Upper Nile and Jonglei) are planned for 2 December 2014 and January 2015 with trivalent OPV. The objective is to rapidly stop the cVDPV2 in the internally-displaced persons camp and prevent further spread, while further boosting immunity to type 1 polio and minimize risk of re-infection from other parts of the Horn of Africa.

Madagascar
In Madagascar, cVDPV type 1 (cVDPV1) has been confirmed after the virus was isolated from 1 case of AFP (onset of paralysis on 29 September 2014) and 3 healthy contacts. The most recent supplementary immunization activities in Madagascar were conducted in December 2011/January 2012. SNIDs are planned for December, with NIDs to be held in January 2015. An estimated more than 25% of children remain under-immunized against poliovirus in the country. Madagascar was previously affected by a cVDPV2 outbreak in 2001/2002 (resulting in 5 cases) and in 2005 (resulting in 5 cases). A VDPV was also isolated during a research study among healthy children in Toliara I in 2011. Concerted outbreak response each time rapidly stopped those events. However, repeated emergence of separate cVDPV events underscores the risk of these events occurring in populations which are not fully immunized and of the importance of maintaining high levels of vaccination coverage.

WHO risk assessment
Circulating VDPVs are rare but well-documented strains of poliovirus which can emerge in some populations which are inadequately immunized. Due to the small risk of cVDPVs, use of OPV must be stopped to secure a lasting polio-free world. OPV will be withdrawn in a phased manner, beginning with the removal of type 2-containing OPV. The type 2 component contained in trivalent OPV accounts for 90% of all cVDPV cases.
In South Sudan, given that the cases detected are in an internally-displaced persons camp which can be accessed for vaccination, the World Health Organization (WHO) assesses the risk of international spread of the cVDPV2 from South Sudan to be low. However, the risk of international spread would increase if other areas are infected by the cVDPV2. With regard to Madagascar, given the history associated with previous cVDPVs, WHO assesses the risk of international spread from Madagascar to be low.
WHO advice
It is important that all countries, in particular those with frequent travel and contacts with polio-affected countries and areas, strengthen surveillance for AFP cases in order to rapidly detect any new virus importation and to facilitate a rapid response. Countries, territories and areas should also maintain uniformly high routine immunization coverage at the district level to minimize the consequences of any new virus introduction.
WHO’s International Travel and Health recommends that all travelers to polio-affected areas be fully vaccinated against polio. Residents (and visitors for more than 4 weeks) from infected areas should receive an additional dose of OPV or inactivated polio vaccine (IPV) within 4 weeks to 12 months of travel.

G20 Leaders’ Brisbane Statement on Ebola
15/11/14
G20 Meeting, Brisbane, Australia https://www.g20.org/
[Full text]
We are deeply concerned about the Ebola outbreak in Guinea, Liberia and Sierra Leone and saddened by the suffering and loss of life it is inflicting. We are mindful of the serious humanitarian, social and economic impacts on those countries, and of the potential for these impacts to spread.

The governments and people of Guinea, Liberia and Sierra Leone are making tremendous efforts to fight the outbreak, with the support of the African Union and other African countries. We commend the brave service of health care and relief workers. We also applaud the contributions of countries worldwide, the United Nations (UN) and its bodies such as the World Health Organization (WHO), international and regional organisations and financial institutions, non-governmental and religious organisations, and the private sector. We fully support the UN Mission for Ebola Emergency Response’s ongoing work to harness capacity to stop the outbreak, treat the infected, ensure essential services, preserve stability and prevent further outbreaks and urge that it act swiftly to achieve these objectives.

G20 members are committed to do what is necessary to ensure the international effort can extinguish the outbreak and address its medium-term economic and humanitarian costs. We will work through bilateral, regional and multilateral channels, and in partnership with non-governmental stakeholders. We will share our experiences of successfully fighting Ebola with our partners, including to promote safe conditions and training for health care and relief workers. We will work to expedite the effective and targeted disbursement of funds and other assistance, balancing between emergency and longer-term needs.

We invite those governments that have yet to do so to join in providing financial contributions, appropriately qualified and trained medical teams and personnel, medical and protective equipment, and medicines and treatments. While commending ongoing work, we urge greater efforts by researchers, regulators and pharmaceutical companies to develop safe, effective and affordable diagnostic tools, vaccines and treatments. We call upon international and regional institutions, civil society and the private sector to work with governments to mitigate the impacts of the crisis and ensure the longer-term economic recovery.

In this regard, we urge the World Bank Group (WBG) and International Monetary Fund (IMF) to continue their strong support for the affected countries and welcome the IMF’s initiative to make available a further $300 million to stem the Ebola outbreak and ease pressures on Guinea, Liberia and Sierra Leone, through a combination of concessional loans, debt relief, and grants. We ask the IMF and WBG to explore new, flexible mechanisms to address the economic effects of future comparable crises.

This outbreak illustrates the urgency of addressing longer-term systemic issues and gaps in capability, preparedness and response capacity that expose the global economy to the impacts of infectious disease. G20 members recommit to full implementation of the WHO’s International Health Regulations (IHR). To this end, and in the context of our broader efforts to strengthen health systems globally, we commit to support others to implement the IHR and to build capacity to prevent, detect, report early and rapidly respond to infectious diseases like Ebola.

We also commit to fight anti-microbial resistance. Interested G20 members are supporting this goal through initiatives to accelerate action across the Economic Community of West African States and other vulnerable regions and will report progress and announce a time frame by May 2015 at the World Health Assembly.

We invite all countries to join us in mobilising resources to strengthen national, regional and global preparedness against the threat posed by infectious diseases to global health and strong, sustainable and balanced growth for all. We will remain vigilant and responsive.

MSF: Ebola Treatment Trials to Start at MSF Sites in December
November 13, 2014
GENEVA/NEW YORK—In the absence of specific treatments for Ebola, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières(MSF) announced today that it will host clinical trials in three Ebola treatment centers in West Africa. The separate trials, which are aimed at quickly finding an effective therapy that can be used against the disease, which has so far taken around 5,000 lives in the current outbreak in the region, will be led by three different research partners.

The French National Institute of Health and Medical Research (INSERM) will lead a trial using antiviral drug favipiravir in Guéckédou, Guinea; the Antwerp Institute of Tropical Medicine (ITM) will lead a trial of convalescent whole blood and plasma therapy at the Donka Ebola center in Conakry, Guinea; and the University of Oxford will lead, on behalf of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), a Wellcome Trust-funded trial of the antiviral drug brincidofovir at a site yet to be determined. The World Health Organization (WHO) and health authorities of the affected countries are also taking part in this collaborative effort.

“This is an unprecedented international partnership that represents hope for patients to finally get a real treatment against a disease that today kills between 50 and 80 percent of those infected,” said Dr. Annick Antierens, who coordinates investigational partnerships for MSF. “As one of the principal providers of medical care to Ebola patients in West Africa, MSF is taking part in these accelerated clinical trials to give people affected by the current outbreak a better chance of survival.”

The trials’ protocols are in the final stages of development and are designed with a simple target of 14-day survival and with broad inclusion criteria. The protocols will ensure that disruption to patient care will be minimal, that internationally accepted medical and research ethical standards are respected, and that sound scientific data will be produced and shared for public good. The main principles and designs have been shared with the respective countries’ ethical authorities, with the goal of starting the first trials in December 2014. Initial results could be available in February 2015.

The two drugs, brincidofovir and favipiravir, were selected from WHO’s shortlist of potential Ebola treatments after careful review of safety and efficacy profiles, product availability, and ease of administration to patients.

“Conducting clinical trials of investigational drugs in the midst of a humanitarian crisis is a new experience for all of us, but we are determined not to fail the people of West Africa,” said professor Peter Horby, chief investigator of the ISARIC-led trial. “It has been a privilege to witness the extraordinary willingness of all the partners in this initiative to step outside their comfort zones in order to fast track these critically important trials.”

“These three trials are part of the first phase of research aimed at finding the best treatment to cure patients with Ebola,” said professor Denis Malvy, who will lead the INSERM trial in Guinea. “The three trial boards will therefore be coordinated in a very reactive way, so that any new fact can be discussed rapidly and our research plans can be adapted accordingly. Strengthening the link between our teams is all the more important as there is the possibility that, should our trials give positive results, the next phase could consist of combining interventions.”

Trial of convalescent whole blood and plasma therapy will consist of administering blood or plasma that contains antibodies from survivors to infected patients. This approach is also endorsed by the WHO.

“Convalescent plasma from recovered patients, containing antibodies against pathogens, has been safely used for other infectious diseases,” said ITM’s Johan van Griensven, coordinating investigator of the trial. “We want to find out whether it works for Ebola, whether it is safe and whether it can be scaled-up to reduce the number of deaths in the current outbreak. Close communication with people who recovered from Ebola, and the community at large, will be vital for a successful trial. We hope that recovered patients donating blood and plasma to help sick people could reduce fear of the disease and reduce stigmatization of those who survived.”

When other experimental or off-label products with promising efficacy and safety data become available, they will be assessed with the view of proposing further trials in other MSF Ebola management centers, including in Sierra Leone.

All three trials will prioritize community engagement and informed consent from patients or their representatives. Each patient who consents to be part of a trial will have the potential risks of being subjected to a new therapy clearly explained.

“We need to keep in mind that there is no guarantee that these therapies will be the miracle cure,” said Dr. Antierens of MSF. “But we need to do all we can to try the products available today to increase the chances of finding an effective treatment against Ebola.”

While clinical trials are underway, MSF is urging the drugs’ developers to scale up production now, to ensure there is no gap between the end of the trials and the large-scale introduction of products found to be safe and effective. MSF is also urging drug manufacturers to ensure that end products are affordable and available in the quantities needed to tackle the outbreak at its epicenter in West Africa. Distribution of end products should be driven by needs, irrespective of where people live or the capacity of a country to purchase medicines

WHO: Ebola Virus Disease (EVD)
Situation report – 14 November 2014 – ‘WHO Roadmap’
HIGHLIGHTS
:: There have been 14 413 reported Ebola cases in eight countries since the outbreak began, with 5177 reported deaths.
:: Case incidence continues to increase in Sierra Leone, and transmission also remains intense in Guinea and Liberia.
:: A total of 4 cases, including 3 deaths, have been reported in Mali.

WHO: Ebola situation assessments
:: Mali confirms its second fatal case of Ebola virus disease
12 November 2014