From Google Scholar+ [to 24 January 2015]

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

Influenza and Other Respiratory Viruses
January 2015 Volume 9, Issue 1 Pages i–i, 1–57
http://onlinelibrary.wiley.com/doi/10.1111/irv.2014.9.issue-1/issuetoc
Short Article
Introducing seasonal influenza vaccine in low‐income countries: an adverse events following immunization survey in the Lao People’s Democratic Republic
Manilay Phengxay1,*, Sara A. Mirza2, Rita Reyburn1, Anonh Xeuatvongsa3, Christian Winter1, Hannah Lewis1, Sonja J. Olsen2, Reiko Tsuyuoka1, Viengphone Khanthamaly4, Francisco S. Palomeque2, Joseph S. Bresee2, Ann C. Moen2, Andrew L. Corwin4 and for the Lao PDR Field Epidemiology Training Cohort Team†
Article first published online: 17 JAN 2015
DOI: 10.1111/irv.12299
Abstract
Objective
In 2012, Lao PDR introduced seasonal influenza vaccine in pregnant women, persons aged ≥50 years, persons with chronic diseases, and healthcare personnel. We assessed adverse events following immunization (AEFI).
Methods
We used a multistage randomized cluster sample design to interview vaccine recipients.
Findings
Between April and May 2012, 355 902 were vaccinated. Of 2089 persons interviewed, 261 (12•5%) reported one or more AEFI. The most commonly reported AEFIs were local reactions. No hospitalizations or deaths were reported; 16% sought medical care. Acceptance and awareness of vaccination were high.
Conclusions
Following the introduction of seasonal influenza vaccine in Lao PDR, self-reported adverse events were mild.

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American Journal of Men’s Health (AJMH)
January 2015; 9 (1)
http://jmh.sagepub.com/content/current
Published online before print January 15, 2015, doi: 10.1177/1557988314567324
Has Their Son Been Vaccinated? Beliefs About Other Parents Matter for Human Papillomavirus Vaccine
Christine L. Schuler, MD, MPH1, Tamera Coyne-Beasley, MD, MPH2
1Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
2University of North Carolina, Chapel Hill, NC, USA
Abstract
The goal of this study was to determine if parents’ beliefs about social norms of human papillomavirus (HPV) vaccination for sons were associated with knowledge of HPV, intention to vaccinate sons, or beliefs about side effects. A cross-sectional, survey-based study of parents with sons was performed in 2010. Fisher’s exact tests were used to examine associations between demographics and responses about social norms. Multivariate logistic regression models examined beliefs about social norms of male HPV vaccination and primary outcomes.

Few parents agreed that others were vaccinating sons (n = 31/267, 12%), including 1% responding strongly agree and 11% responding agree. Most parents, 52%, disagreed that others were vaccinating (40% disagree, 11% strongly disagree), and 37% chose prefer not to answer regarding others’ vaccination practices. Hispanic parents and those with a high school education or less were significantly more likely to choose prefer not to answer than their respective counterparts regarding vaccination norms. In multivariate models, parents agreeing others were vaccinating sons had greater odds of having high knowledge of HPV (adjusted odds ratio [aOR] high vs low knowledge 3.15, 95% confidence interval [CI] 1.13, 8.77) and increased intention to vaccinate sons (n = 243, aOR = 4.41, 95% CI = 1.51, 12.89).

Beliefs about side effects were not significantly associated with beliefs about social norms. Parents’ beliefs about others’ vaccination practices are important with regard to knowledge of HPV and intention to vaccinate sons. Studying how various public messages about HPV vaccine may influence normative beliefs could be relevant to improving vaccination coverage.

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Journal of Paediatrics and Child Health
January 2015 Volume 51, Issue 1 Pages 1–128
http://onlinelibrary.wiley.com/doi/10.1111/jpc.2015.51.issue-1/issuetoc
Article first published online: 14 JAN 2015
Review Article
Conquering rotavirus: From discovery to global vaccine implementation
Julie E Bines1,2,3,* and Carl D Kirkwood1,2
DOI: 10.1111/jpc.12815
Abstract
Rotavirus, the commonest cause of severe dehydrating gastroenteritis world-wide, was discovered less than 50 years ago. It causes about 450 000 deaths per year in children <5 years of age and hospitalises millions more. Rotavirus vaccines have been shown to have a major impact on hospital admissions due to rotavirus gastroenteritis and all-cause gastroenteritis and reduce mortality in developing countries. In Australia, there has been a 71% decrease in rotavirus hospitalisations in children 0–5 years of age. From the discovery of rotavirus as the major causative agent for severe gastroenteritis, through vaccine development and vaccine post-marketing surveillance activities, Australian scientists and clinicians have played a significant role in the global effort to reduce the burden of rotavirus infection.

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Nature Genetics
January 2015, Volume 47 No 1 pp1-97
http://www.nature.com/ng/journal/v47/n1/index.html
Published online 19 January 2015
Evolutionary history and global spread of the Mycobacterium tuberculosis Beijing lineage
Matthias Merker, Camille Blin, Stefano Mona, Nicolas Duforet-Frebourg, Sophie Lecher, Eve Willery, Michael Blum, Sabine Rüsch-Gerdes, Igor Mokrousov, Eman Aleksic, Caroline Allix-Béguec, Annick Antierens, Ewa Augustynowicz-Kopeć, Marie Ballif, Francesca Barletta, Hans Peter Beck, Clifton E Barry III, Maryline Bonnet, Emanuele Borroni, Isolina Campos-Herrero,
Daniela Cirillo, Helen Cox, Suzanne Crowe, Valeriu Crudu, Roland Diel et al.
Affiliations
doi:10.1038/ng.3195
Abstract
Mycobacterium tuberculosis strains of the Beijing lineage are globally distributed and are associated with the massive spread of multidrug-resistant (MDR) tuberculosis in Eurasia. Here we reconstructed the biogeographical structure and evolutionary history of this lineage by genetic analysis of 4,987 isolates from 99 countries and whole-genome sequencing of 110 representative isolates. We show that this lineage initially originated in the Far East, from where it radiated worldwide in several waves. We detected successive increases in population size for this pathogen over the last 200 years, practically coinciding with the Industrial Revolution, the First World War and HIV epidemics. Two MDR clones of this lineage started to spread throughout central Asia and Russia concomitantly with the collapse of the public health system in the former Soviet Union. Mutations identified in genes putatively under positive selection and associated with virulence might have favored the expansion of the most successful branches of the lineage.

Media/Policy Watch [to 24 July 2015]

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

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

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 24 January 2015
The Financial Consequences of a Bad Flu Shot
Bourree Lam Jan 21 2015, 7:30 AM ET
While the CDC doesn’t have an official estimate for the economic costs of ineffective seasonal vaccines, various studies have suggested that resistant viral strains can weigh on the economy.

Forbes
http://www.forbes.com/
Accessed 24 January 2015
Gates Foundation CEO: “History Is Going To Judge Us”
1/16/2015
Sue Desmond-Hellmann, the CEO of The Bill & Melinda Gates Foundation, came to San Francisco this week to meet with some of the life science and healthcare executives in town for the annual JP Morgan Healthcare Conference, which draws thousands of people from around the country and the world. Desmond-Hellmann and I got a chance to talk during her visit about what’s new and what’s in store at the foundation funded by the world’s two richest men — Bill Gates and Warren Buffett.

Desmond-Hellmann became the CEO of what is arguably the world’s largest private foundation (it has a $42.3 billion trust endowment) last May, after serving as chancellor of the University of California, San Francisco and working as the head of development at Genentech, where she led the development of cancer drugs Herceptin and Avastin.

Now, she’s on the other side of the table, trying to coax pharmaceutical company executives to produce vaccines for people in poor countries. “Capitalism and private companies are good at solving problems,” but not necessarily the problems of poor people, said Desmond-Hellmann. “What the foundation has started to do, which is exciting, [is looking at how] can we help create the market conditions that allow private companies to care about and start to work with us to solve the problems.” These are problems including malaria, HIV and neglected infectious diseases, including Ebola…

Fortune
http://fortune.com/
Accessed 24 January 2015
One shot to cure them all: The quest for the universal flu shot
by Erika Fry
January 21, 2015, 8:30 AM EST
The latest flu vaccine is no match for the year’s most common strains—but there’s a better way to fight the virus.

The Huffington Post
http://www.huffingtonpost.com/
Accessed 24 January 2015
A Birthday Gift to Last a Lifetime: Seth Berkley
22 January 2015
For most people a birthday is a cause for celebration, and today, 15 years after Gavi was first born — right here at the World Economic Forum in Davos — is certainly no exception. But for millions of children living in the poorest parts of the world a birthday means so much more, and is a truly life-changing milestone. That’s because growing up for example in sub-Saharan Africa, you are 15 times less likely to live long enough to see your fifth birthday, compared to children in wealthier parts of the world…

New York Times
http://www.nytimes.com/
Accessed 24 January 2015
Liberia Ebola Vaccine Trial ‘Challenging’ as Cases Tumble
January 24, 2015
West Africa, aims to enroll at-risk people such as healthcare staff, family members and burial workers. It will test a GSK vaccine, a rival one from Merck and NewLink, and a placebo. “It may, at this point, be hard to find 27,000…

Doctors Group Urges Measles Shots as Disneyland Outbreak Spreads
spread to more than 80 people in seven states and Mexico. The American Academy of Pediatrics said all children should get the vaccine for measles, mumps and rubella between 12 and 15 months of age and again between 4 and 6 years
January 24, 2015

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 24 January 2015
Study of Ebola Drug ZMapp Set for West Africa
24 January 20215
A clinical trial of the experimental Ebola drug ZMapp may be ready to get under way in infected patients in West Africa in February, the latest effort to combat the current epidemic and any future outbreaks.

Washington Post
http://www.washingtonpost.com/
Accessed 24 January 2015
Africa
U.S.-built Ebola treatment centers in Liberia are nearly empty as outbreak fades
Kevin Sieff January 18
…It now appears that the alarming epidemiological predictions that in large part prompted the U.S. aid effort here were far too bleak. Although future flare-ups of the disease are possible, the near-empty Ebola centers tell the story of an aggressive American military and civilian response that occurred too late to help the bulk of the more than 8,300 Liberians who became infected. Last week, even as international aid organizations built yet more Ebola centers, there was an average of less than one new case reported in Liberia per day.
“If they had been built when we needed them, it wouldn’t have been too much,” said Moses Massaquoi, the Liberian government’s chairman for Ebola case management. “But they were too late.”…

Ebola/EVD: Additional Coverage [to 24 January 2015]

Ebola/EVD: Additional Coverage [to 24 January 2015]

UNMEER [UN Mission for Ebola Emergency Response] @UNMEER #EbolaResponse

Editor’s Note: UNMEER’s website is aggregating and presenting content from various sources including its own External Situation Reports, press releases, statements and other formats.
We present a composite below from the week ending 24 January 2015. We also note that 1) a regular information category in these reports – human rights – has apparently eliminated as it no longer appears in any of the continuing updates, and 2) the content level of these reports continues, in our view, to trend less informative and less coherent. We will review continuing coverage of this material over the next few weeks.

UNMEER External Situation Reports
UNMEER External Situation Reports are issued daily (excepting Saturday) with content organized under these headings:
– Highlights
– Key Political and Economic Developments
– Human Rights
– Response Efforts and Health
– Logistics
– Outreach and Education
– Resource Mobilisation
– Essential Services
– Upcoming Events
The “Week in Review” will present highly-selected elements of interest from these reports. The full daily report is available as a pdf using the link provided by the report date.

:: 23 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. In Davos, Switzerland, a panel discussion on ‘Confronting the Challenge of Catastrophic Outbreaks: What critical lessons can be learned from the 2014 Ebola outbreak to prepare us for the future?’ was held on 22 January. Moderating the talks, Peter Piot, the Director of the London School of Hygiene & Tropical Medicine, characterized the EVD outbreak in West Africa as a black swan event. The panel which included President Alpha Condé of Guinea and WHO Director-General Margaret Chan underscored the need to guard against complacency and donor fatigue, until we get to zero transmission as well as build resilient public health care systems and infrastructure to better cope with future outbreaks and endemic diseases.
Outreach and Education
10. Community resistance towards safe burials and general suspicion of burial teams continues in many parts of the Liberia. UNMEER and partners are engaging more with local communities to enhance awareness in the Phase II national response efforts. In this regard, UNMEER along with county authorities plan to follow up on some recent burials that took place in Flowin, Garbusi and Boapea towns in Nimba County.
Resource Mobilisation
7. The OCHA Ebola Virus Outbreak Overview of Needs and Requirements, now totaling USD 1.5 billion, has been funded for USD 1.18 billion, which is around 79% of the total ask.
8. The Ebola Response Multi-Partner Trust Fund currently has USD 135.8 million in commitments. In total USD 140 million has been pledged.
Essential Services
14. WFP, in coordination with the Government of Liberia, UNMEER and UNICEF, will be supporting re-opening of schools starting in February: WFP will facilitate the transport of WASH supplies to ensure that schools, as they open, have all supplies necessary to prevent the transmission of EVD.
15. In Sierra Leone, two successive emergency campaigns to distribute anti-malarial drugs successfully reached more than 2.5 million people in door-to-door distribution in 8 districts (Bombali, Kambia, Koinadugu, Moyamba, Port Loko and Tonkolili and Western Area – Urban and Rural). The campaign was implemented by the National Malaria Control Programme of the Ministry of Health and Sanitation with technical support and guidance by WHO in collaboration with MSF, UNICEF and other Roll Back Malaria partners. This effort will significantly reduce the number of people with fever that might be mistaken for EVD.

:: 22 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. In a World Bank Report prepared for the 2015 World Economic Forum in Davos, the Bank acknowledged progress made in slowing the EVD transmission rate, but cautioned that recent efforts have likely reduced the impact of Ebola on the African economy perhaps from USD 30 billion to USD 6 billion. The report noted that most of these losses are forecasted to hit the affected countries.
2. In Davos, Switzerland, Special Envoy David Nabarro provided an updated Overview of Needs and Requirements in the global efforts to stop Ebola. The financial needs for the first six month of 2015 amount to 1.5 billion USD. Almost 500 million USD is already available and the appeal is now for the gap of 1 billion USD.
Response Efforts and Health
7. In Sierra Leone, 19,673 Ebola Response Workers (ERWs) were paid through mobile money between 7 and 19 January. Of these, 96% have cash-out their pay.
Essential Services
18. Following the reopening of schools in Guinea, attendance remain low in the first week. UNICEF and partners continue to monitor schools to ensure measures put in place for the safe return to school are being adhered to around the country. UNICEF and Enfance du Globe provided psychosocial support to 150 children affected by Ebola in Belya.

:: 21 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. The UN General Assembly held an informal meeting on Ebola, yesterday and received briefings from the Secretary-General, SRSG Ould Cheikh Ahmed, SE David Nabarro and representatives of the affected countries among others. Participants assessed that the global response to address Ebola has significantly slowed transmission, highlighted that there is no room for complacency and reiterated the goal to reach zero transmission.
Logistics
7. WFP is enhancing operational capacity to undertake medical evacuation of humanitarian staff with EVD by deploying a WFP-charted Bell 412 helicopter to Freetown, Sierra Leone on 22 January. Plans are for the aircraft to be based in Freetown initially, and then to operate out of a field location, such as Bo or Port Loko, as required. This is the second dedicated Medevac helicopter that WFP has deployed to the region; the other is stationed in Conakry, serving Guinea.
Essential Services
18. Following the reopening of schools in Guinea, attendance remain low in the first week. UNICEF and partners continue to monitor schools to ensure measures put in place for the safe return to school are being adhered to around the country. UNICEF and Enfance du Globe provided psychosocial support to 150 children affected by Ebola in Belya.

:: 20 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. In a press interview on his way to the World Economic Forum in Davos, Switzerland, President Alpha Condé of Guinea called on the IMF to cancel the debt of his country as well as of Liberia and Sierra Leone. He further indicated that the cancellation should be for bilateral and multilateral debt.
Outreach and Education
13. Similarly, UNICEF helped the Ministry of Youth broadcast Ebola sensitization messages to youth during the Africa Nations Cup. Messaging will continue 30 days after the end of the African Cup. UNICEF provided flat screen TVs, generators, retro-projectors, and screens to broadcast the Cup in 200 locations throughout the country.
Essential Services
16. Schools reopened across Guinea yesterday. In preparation, 80,657 teachers were trained on safe school opening protocol (100% teachers from preschool to higher education) with the assistance of UNICEF. UNICEF and partners also helped ensuring that thermoflash and hand washing stations were provided on locations. Early reporting suggests attendance is low, with for instance 63 students present at the Lycée 2 Octobre in Conakry out of 1,300 students. Current estimates are that students will receive 160 of the usual 180 days of instruction and local media are encouraging attendance to make best use of the reduced time.
18. In Liberia, schools began registering students on 12 January for the launch of the new academic year, and the Ministry of Education finalized a condensed 2015 academic calendar, including a minimum of 187 instructional days from 2 February to 2 November.

:: 19 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. On 18 January, the Government of Mali, WHO and UNMEER declared Mali Ebola-free, after 42 days without any new EVD cases. They insisted on the need to remain vigilant as long as the outbreak is not contained in the three most affected countries.
4. The Red Cross indicated that security challenges in several areas in Guinea have prevented safe and dignified burials. The National Response Coordinator will work with both the gendarmerie and the Red Cross to look at the feasibility of escorts for safe burial teams.
9. In preparation for the potential reopening of the Liberia and Sierra Leone border, IOM Regional Office Dakar has signed a Memorandum of Understanding with the Mano River Union. IOM is urgently initiating a comprehensive border assessment in coordination with CDC.
Logistics
11. The WFP-led Emergency Telecoms (ET) Cluster is providing internet connectivity in 43 locations across the three Ebola-affected countries, ensuring reliable internet access for 741 humanitarian personnel. Last week in Guinea, the ET Cluster installed internet in the Ebola Treatment Unit (ETU) in Beyla to facilitate the critical efforts of health workers. It also installed radio equipment in the city of Kissidougou to enable humanitarian staff to communicate with one another and a radio base station for UNHAS/UNMEER in Conakry, in order to provide reliable communications between air and ground staff.
Essential Services
19. Schools and universities in Guinea are scheduled to reopen today.

Vaccines and Global Health: The Week in Review 17 January 2015

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

.Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_17 January 2015

blog edition: comprised of the approx. 35+ entries posted below on this date.

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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Support:  If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary, and follow the relevant steps . Thank you…

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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

POLIO [to 17 January 2015]

POLIO [to 17 January 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 14 January 2014
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: More than 6 months have passed since the most recent case of wild poliovirus in central Africa was detected in Cameroon on the 9 July 2014. This indicates that progress towards stopping the outbreak in this region is being made. However, outbreak response activities must continue and subnational surveillance systems strengthened to ensure the rapid detection of any residual transmission.
:: More than a year has passed since the last case of wild poliovirus in Ethiopia. With the most recent wild poliovirus case in the Horn of Africa detected in August 2014 in Somalia, outbreak response across the region is continuing.
:: No new cases of wild poliovirus have been reported anywhere in the world this week.

Selected country report content:
West Africa
:: The Ebola crisis in western Africa continues to have an impact on the implementation of polio eradication activities in Liberia, Guinea and Sierra Leone. Supplementary immunization activities (SIAs) in these countries have been postponed and the quality of acute flaccid paralysis surveillance has markedly decreased throughout 2014. National Immunization Days (NIDs) have been rescheduled for Guinea, Liberia and Sierra Leone from the 27 to 31 March. The programme continues to monitor the situation with concern.
:: Even as polio programme staff across West Africa support efforts to control the Ebola outbreak affecting the region, efforts are being made in those countries not affected by Ebola to vaccinate children against polio to create a buffer zone surrounding the Ebola-affected countries.
:: NIDs are planned using bivalent oral polio vaccine (OPV) in Niger and Benin on 27 February to 2 March, and Subnational Immunization Days (SNIDs) tentatively in Mali in February with dates to be confirmed. From the 27 to 31 March, NIDs will take place in Benin, Burkina Faso, Cote d’Ivoire, Mali, Niger and Senegal using trivalent OPV.

EBOLA/EVD [to 17 January 2015]

EBOLA/EVD [to 17 January 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Editor’s Note:
Our extensive coverage of Ebola/EVD activity continues – including detailed coverage of UNMEER now available at the end of this digest and other INGO/agency activity reported in the relevant sections below. Please also note that many of the journals we cover continue to publish important EVD content which is threaded throughout this edition.
We note that the WHO will hold a “Special Session of the Executive Board on the Ebola Emergency” at its meeting later in January, with supporting documentation just below. This content includes an important call for a resolution to clarify and affirm the WHO’s role in large-scale health emergencies overall.

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:: 136th WHO Executive Board session
26 January–3 February 2015 –
Main Documents: http://apps.who.int/gb/e/e_eb136.html
Selected documents of interest to Ebola:
EB136/49 – Ensuring WHO’s capacity to prepare for and respond to future large-scale and sustained outbreaks and emergencies
[Excerpt]
…4. As the number of emergencies with public health implications is rising, the need for effective, efficient and well-designed global response capacities has never been clearer. Though WHO has often been called on to support Member States as they respond to crises, the unprecedented complexity and scale of the current Ebola outbreak demonstrates that the Organization’s capacities, methods and approaches are not necessarily scalable or adaptable to novel or larger challenges. Further, WHO’s focus on technical support and normative guidance has left a gap in institutional capacity for and appreciation of the importance of operations.

5. The international community expects WHO to be able to mount a comprehensive and rapid response, whenever and wherever an emergency that impacts public health arises that outstrips national capacity. To meet this expectation, the Organization’s emergency management capacity must be ready to address the public health impact of emergencies of any category, irrespective of hazard, across the full emergency risk management spectrum. Today, WHO has the essential institutional experience and country presence needed, but is not designed or capacitated to fulfil this function. To rectify this, WHO must substantially strengthen and modernize its emergency management capacity.

In moving this forward, it is necessary that:
(a) there is a recognition and clear delineation of WHO’s mandate and role in emergency response;
(b) effective crisis management mechanisms – systems and structures – exist to enable WHO to fulfil that role;
(c) adequate capacities exists to predictably apply these crisis management mechanisms;
(d) appropriate and dedicated funding is in place; and
(e) a robust performance management and accountability framework is in place to provide timely, systematic and comprehensive evaluation of the Organization’s emergency response, and recalibration as required.

6. As such, a package of five proposals for adapting, modernizing and reforming WHO are presented here. If implemented, these changes could capacitate the Organization to successfully lead in protecting the most vulnerable populations from the devastating public health impacts of emergencies…

EB136/26
[Ebola] Current context and challenges; stopping the epidemic; and preparedness in non-affected countries and regions
EB136/INF./4
Fast-tracking the development and prospective roll-out of vaccines, therapies and diagnostics in response to Ebola virus disease
Special Session of the Executive Board on the Ebola Emergency
EB136/INF./5
Building resilient health systems in Ebola-affected countries
Special Session of the Executive Board on the Ebola Emergency
EB136/INF./6
Highlight of efforts made to date towards preparing non-affected countries and
regions to respond to potential importation of EVD
Special Session of the Executive Board on the Ebola Emergency
EB136/INF./7
IHR and Ebola

WHO: Ebola/EVD Response [to 17 January 2015]

WHO: Ebola response roadmap – Situation report 14 January 2015
[Excerpt]
Summary
:: Guinea reported its lowest weekly total of new confirmed Ebola virus disease (EVD) cases since the week ending 17 August 2014. Case numbers remain low in Liberia, with no confirmed cases nationally for the final 2 days of the week ending 11 January, and the lowest weekly total of confirmed cases since the first week of June 2014. Sierra Leone has now reported a decline in case incidence for the second week running, and recorded its lowest weekly total of new confirmed cases since the week ending 31 August 2014.

:: Each of the intense-transmission countries has sufficient capacity to isolate and treat patients, with more than 2 treatment beds per reported confirmed and probable case. However, the uneven geographical distribution of beds and cases, and the under-reporting of cases, means that not all EVD cases are isolated in several areas.

:: Similarly, each country has sufficient capacity to bury all people known to have died from EVD. However, the under-reporting of deaths means that not all burials are done safely.

:: Guinea, Liberia and Sierra Leone report that between 84% and 99% of registered contacts are monitored, though the number of contacts traced per EVD case remains lower than expected in many districts. In areas where transmission has been driven down to low levels, rigorous contact tracing will be essential to break chains of transmission. In the week to January 11, 15% of new confirmed cases in Guinea arose from known contacts (equivalent information is not yet available for Liberia and Sierra Leone).

:: There are currently 27 laboratories providing case-confirmation services in the 3 intense-transmission countries. Four more laboratories are planned in order to meet demand.

:: Case fatality among hospitalized patients (calculated from all hospitalized patients with a reported definitive outcome) is between 57% and 60% in the 3 intense-transmission countries.
A total of 825 health-care worker infections have been reported in the 3 intense-transmission countries; there have been 493 reported deaths.

:: Many elements of the response to the Ebola outbreak, from safe burials to contact tracing, rely on actively engaging affected communities to take ownership of the response. At present, 33 of 38 (87%) of districts in Guinea, 100% of districts in Liberia, and 57% (8 of 14) of districts in Sierra Leone have systems in place to monitor community engagement activities….

…There have been in excess of 21,000 reported confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (table 1), with more than 8,300 deaths (outcomes are under-reported)…
WHO: Video, audio and transcripts from the Ebola briefings
9 January 2015: Virtual press conference following the second high-level meeting on ebola vaccines access and financing. Discussion included the status of candidate vaccine clinical trials and scenarios about trial results and deployment recommendations.
– Audio of the press briefing
47 Mb, 50 minutes
– Transcript of the press briefing
pdf, 436kb
WHO: One year into the Ebola epidemic: a deadly, tenacious and unforgiving virus
15 January 2015 — Series of 14 papers that take an in-depth look at West Africa’s first epidemic of Ebola virus disease

One year after the first Ebola cases started to surface in Guinea, WHO is publishing this series of 14 papers that take an in-depth look at West Africa’s first epidemic of Ebola virus disease.

Introduction – This assessment looks at how West Africa’s epidemic of Ebola virus disease has evolved over the past year, giving special attention to the situation in Guinea, Liberia, and Sierra Leone. The success stories in Senegal, Nigeria, and likely Mali are also described to show what has worked best to limit onward transmission of Ebola following an imported case and bring the outbreak to a rapid end. The fact that a densely populated city like Lagos was successful in containing Ebola offers encouragement that other developing countries can do the same.
An overview of how the outbreak in the Democratic Republic of Congo evolved and was brought under control underscores the many differences between the outbreaks in West Africa and in equatorial Africa, where all previous outbreaks since the first two in 1976 have occurred.

Key events in the WHO response are outlined to show how initial control efforts were eventually overwhelmed by the wide geographical dispersion of transmission, the unprecedented operational complexity of the outbreaks, and the many factors that undermined the power of traditional containment measures to disrupt transmission chains. These factors are also described.

In efforts coordinated by WHO, scientists and the pharmaceutical industry have geared up to develop, test, license, and introduce the first Ebola vaccines, therapies, and point-of-care diagnostic tests. As a strong expression of solidarity with the people of West Africa, these groups are attempting to compress work that normally takes two to four years into a matter of months.

Finally, the assessment takes a look at the potential future evolution of the Ebola epidemic. Based on what has been learned during this first year, what critical strategies and interventions will give countries and their partners the best chance of bringing the outbreaks under control?

Contents
1. Introduction
2. Origins of the Ebola epidemic
3. Factors that contributed to undetected spread
4. Guinea: The virus shows its tenacity
5. Liberia: A country and its capital are overwhelmed
6. Sierra Leone: A slow start to an outbreak that eventually outpaced all others
7. Key events in the WHO response
8. WHO technical support – a lasting impact?
9. Modernizing the arsenal of control tools: Ebola vaccines
10. Classical Ebola virus disease in DRC
11. Successful Ebola responses in Nigeria, Senegal, Mali
12. The importance of preparedness – everywhere
13. The warnings the world did not heed
[Excerpt]
…What needs to change
On 25 January 2015, the WHO Executive Board will hold a special session to discuss the Ebola epidemic and what needs to be done to bring it under control. To guide these discussions, WHO staff prepared six background papers, including proposals for changing the systems and structures used by WHO when it responds to emergencies.
In connection with a reform process currently under way at WHO, Executive Board members will consider the extent to which WHO is expected to be operational in the field during extended emergencies, with its staff directly coordinating or supervising the response, or whether the WHO role should be confined to technical guidance and advice. Both functions – providing technical assistance and direct aid are constitutionally mandated. The Board will also consider administrative and managerial arrangements between WHO headquarters and its six regional offices.
14. What needs to happen in 2015

UNMEER Watch [to 17 January 2015]

UNMEER Watch [to 17 January 2015]
:: UN envoy describes ‘sense of self-confidence’ among those battling Ebola outbreak
15 Jan 2015
The United Nations Special Envoy on Ebola today described a growing feeling of confidence among those responding to the outbreak in West Africa, but he warned that there is an absolute need to maintain focus, vigilance and discipline to ensure that the disease is wiped out.

:: Making a difference: Global Ebola Response Outlook Report 2015′
“A product of the Global Ebola Response Information Centre”
January 2015 :: 36 pages Posted on UNMEER website
Contents
– FOREWORD BY SECRETARY-GENERAL BAN KI-MOON

– INTRODUCTION BY THE SECRETARY-GENERAL’S SPECIAL ENVOY ON EBOLA DR. DAVID NABARRO
[Excerpt]
…Ebola has presented the world with an unprecedented challenge, and a unique opportunity. It has revealed flaws in our international and regional public health mechanisms, and the limited capacities within nations to deal with shocks. It has also drawn together an unprecedented coalition that, if it stays focused and committed, will help the Ebola-affected countries to tackle the outbreak and build back better health systems. It will contribute to systems that enable us to be safer and better off in the face of disease threats.

It is never easy to appreciate where we have come from and where we are headed when we are in the midst of a long and uncertain journey. This is especially the case when matters are as challenging and difficult as this Ebola outbreak. The following sections of this Outlook take us back to the beginning of the outbreak and provide perspectives from partners in the Global Ebola Response Coalition on their role, both now and going forward. I am grateful for their contributions and hope all readers will find the Outlook a useful resource as we work together on the 2015 phase of the response.

– PART ONE – FACING THE CRISIS

– PART TWO – BENDING THE CURVE

– PART THREE – THE ROAD TO ZERO

“The statements in this publication are the views of the authors and do not necessarily reflect the policies or the views of the United Nations or partners.”

The EU’s IMI (Innovative Medicines Initiative) announced a series of major grants totaling €200 million supporting its Ebola+ programme

European Union [to 17 January 2015]

The EU’s IMI (Innovative Medicines Initiative) announced a series of major grants totaling €200 million supporting its Ebola+ programme
15 January 2015
Summary
The IMI Ebola+ programme was launched in response to the Ebola virus disease (EVD) outbreak that started in western Africa in 2014. The comprehensive programme contributes to efforts to tackle a wide range of challenges in Ebola research, including vaccines development, clinical trials, storage and transport, as well as diagnostics and treatments. It is hoped that the programme, which complements work being carried out with the support of other funding bodies, will help to make a difference in the current and future outbreaks. In addition to Ebola, the programme will also address related diseases, such as Marburg.

Eight projects, with a total budget of over €200 million, have been selected for funding under the first Ebola+ Call for proposals:

:: VSV-EBOVAC
VSV-EBOVAC will build on existing work to advance the development of the Ebola vaccine candidate VSV-ZEBOV (‘vesicular stomatitis virus-vectored Zaire Ebola vaccine’). The World Health Organization (WHO) has identified VSV-ZEBOV as one of the most promising Ebola vaccine candidates, and clinical trials are already underway in Europe and Africa. The VSV-EBOVAC project will use cutting-edge technologies to carry out in-depth analyses of samples taken from clinical trial participants before and after vaccination. This will allow them to gather vital information on both the strength of the immune responses triggered by the vaccine and vaccine safety.

:: EBOVAC 1 and 2
Between them, the two EBOVAC projects will assess, through clinical trials in Europe and Africa, the safety and tolerability of the ‘prime-boost’ Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. In a prime-boost vaccine regimen, patients are first given a dose to prime the immune system, and then a boost dose which is intended to enhance the immune response over time.

Phase I trials will be carried out by the EBOVAC1 project. These trials will gather preliminary information on the safety and tolerability of the vaccine regimen. The immune response generated by the regimen will also be evaluated longer term.

Subject to review of the preliminary Phase I data, the Phase II and III trials, will be carried out in parallel by the EBOVAC2 and EBOVAC1 projects respectively to speed up the clinical development of the vaccine regimen. In these trials, larger groups of people will receive the vaccine regimen, allowing the projects to gather further information on the regimen’s safety and immunogenicity, including in specific groups such as children and the elderly, and to assess its efficacy against Ebola virus.

:: Vaccine manufacture capability
Ebola vaccines can only be manufactured in facilities with an appropriate biosafety rating. Relatively few manufacturers have the biosafety rating required for the manufacture of Ebola vaccines, and this is slowing down the production of vaccine candidates.

:: EBOMAN
The focus of the EBOMAN project is on accelerating the development and manufacturing of a ‘prime-boost’ Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. In the short term, this will ensure the delivery of sufficient quantities of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen to support the EBOVAC projects to perform the clinical trials. In parallel, this project will create additional vaccine production capacity to allow for the rapid preparation of large quantities of vaccines.

:: Deployment of and compliance with vaccination regimens
For a vaccine to have a real impact on an outbreak, high levels of vaccination coverage are essential. In addition, for lasting protection, two doses of the vaccine may be needed. However, the stigma surrounding Ebola, coupled with a suspicion of vaccines in general, could deter many people from getting vaccinated. Strong communication campaigns are therefore needed to address these challenges.

:: EBODAC
The EBODAC project will develop a communication strategy and tools to promote the acceptance and uptake of new Ebola vaccines. One of the project’s most important products will be a platform, based on mobile technology, dedicated to Ebola vaccines. As well as providing local communities with information on Ebola and vaccines, the platform will send reminders to people receiving the ‘prime boost’ vaccine to return to get their second ‘booster’ dose and facilitate the tracking of vaccination coverage. EBODAC will also set up local training programmes to make sure the communication strategy, and its tools, will be ready for deployment in the local setting.

:: Rapid diagnostic tests
There is an urgent need for fast, reliable tests to determine if someone is infected with Ebola or not. Three projects will pave the way for rapid diagnostic tests capable of delivering reliable results at the point of care in as little as 15 minutes.

:: Mofina
The Mofina project will develop a new diagnostic test that will deliver results in under 45 minutes on whether the patient has Ebola or a related disease such as Marburg virus. Crucially, the device is designed to work well in sites where high-end laboratory infrastructures are simply not available, while also protecting users from infection. The project will draw on two existing technologies: a conventional Ebola virus test, and a point-of-care molecular diagnostics platform. After testing a prototype of the system, the project partners will validate it in the field.

:: FILODIAG
The FILODIAG project aims to deliver an ultra-fast, accurate diagnostic instrument that will test for Ebola in under 15 minutes. Such a system could be used in both healthcare settings and at critical infrastructures like airports. Current tests for Ebola virus take a long time because samples must be heated and then cooled in each of the many processing cycles. This project will replace the heating/cooling steps with a technology based on laser-heated nanoparticles. Early tests of this technology have worked well. The project will add a step to concentrate the virus and refine and test the system before evaluating it in the field.

:: EbolaMoDRAD
The EbolaMoDRAD project aims to develop and validate in the field a rapid diagnostic tool that will be both simple and safe to use in low resource settings by people who may not have specialist training. At the same time, the project will implement a large-scale capacity building programme in West Africa with a strong focus on diagnostics, biosafety, and outbreak management. Finally, it will ensure its results are communicated widely, especially to public health bodies, charities, outbreak management teams, and local hospitals.
Note: The Grant Agreements for some projects are still being finalised. Final information on all selected projects, including full budget details, will be published here once the Grant Agreements have been signed.

:: Future plans
Further Calls for proposals under the Ebola+ programme are planned. These could address issues such as the development of a vaccine that offers broad protection against both Ebola and other, related viruses such as Marburg; the development of new treatments for Ebola; new vaccines that do not require extreme temperatures; and the generation of new diagnostic tests.

Johnson & Johnson Announces Formation of Ebola Vaccine Development Consortia, Gains Funding from Innovative Medicines Initiative

Johnson & Johnson Announces Formation of Ebola Vaccine Development Consortia, Gains Funding from Innovative Medicines Initiative
– Consortia funded through the IMI Ebola+ Programme Supported by the European Commission
– Brings together London School of Hygiene and Tropical Medicine, INSERM, University of Oxford University, La Centre Muraz, Bavarian Nordic A/S, Vibalogics, the Grameen Foundation and World Vision of Ireland with Janssen Pharmaceutical Companies to help accelerate Ad26 – MVA Ebola vaccine development and patient education

NEW BRUNSWICK, N.J., Jan. 16, 2015 /PRNewswire/ — Johnson & Johnson is pleased to announce the formation of consortia with leading global research institutions and non-government organizations to work in conjunction with Janssen Pharmaceutical Companies to accelerate the development of its Ebola vaccine regimen. The Innovative Medicines Initiative (IMI) plans to award these consortia grants totaling more than €100 million from the Ebola+ programme to support the development, manufacturing and patient education for the vaccine regimen.

The IMI is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding for the IMI Ebola+ programme comes in part from Horizon 2020, the European Union’s research and innovation programme, and in part in the form of in-kind contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects.

“In the face of the global challenge of Ebola, bringing together the expertise and capabilities of the pharmaceutical industry, academic centers and NGOs will be critical to help solve this crisis,” said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. “The European Commission’s support through IMI bolsters collaboration that should significantly accelerate efforts to help address this humanitarian crisis.”
“It is great to see the multiple partners come together to accelerate the development of an effective vaccine both for the current epidemic and future outbreaks,” said Professor Peter Piot, M.D., director of the London School of Hygiene & Tropical Medicine, one of the consortia partners. “This is an opportunity to make sure that this is the last Ebola epidemic in which our only tools to control it are isolation and quarantine.”

The funds were announced to support several consortia working together on a total of four projects. Three of the projects are designed to address the need to accelerate Phase I, II and III trials and scale up production of the prime-boost vaccine regimen. A Phase I trial led by Oxford Vaccines Group is currently underway with trials in Africa being planned. The Phase II and III trials in Europe and Africa, subject to review of the preliminary Phase I data, will be carried out in parallel. A fourth project will investigate innovative ways and technology to raise awareness and acceptance of vaccination campaigns. A total of eight projects are being funded under this round of the IMI’s Ebola+ programme.

“With people still contracting this disease, there is still a risk that Ebola will continue to spread and that we could have another major outbreak in the future,” said Johan Van Hoof, M.D., Global Head of Infectious Diseases and Vaccines, Janssen. “We highly appreciate the European Commission’s support and are pleased to be joined by them and our distinguished partners in further accelerating our goal of bringing this vaccine, if approved, to families and frontline health care professionals as fast as possible.”

Professor Andrew Pollard and Dr Matthew Snape, who are leading the Phase I and II Ebola vaccine trials at the University of Oxford for IMI, said “the initial testing of vaccines for Ebola is already underway at the University with an astonishing response from the public to volunteer for the trials, to provide the earliest possible information to guide further studies of a prime boost vaccine, that if approved, may help control the Ebola outbreak in West Africa.”
Organizations joining Janssen include the London School of Hygiene & Tropical Medicine, University of Oxford, Institut National de la Sante et de la Recherche Medicale (INSERM), La Centre Muraz, Bavarian Nordic A/S, Vibalogics, Grameen Foundation and World Vision of Ireland…

Ebola Cases and Health System Demand in Liberia

PLOS Biology
http://journals.plos.org/plosbiology/

Research Article
Ebola Cases and Health System Demand in Liberia
John M. Drake, RajReni B. Kaul, Laura W. Alexander, Suzanne M. O’Regan, Andrew M. Kramer, J. Tomlin Pulliam, Matthew J. Ferrari, Andrew W. Park
Affiliation: Odum School of Ecology, University of Georgia, Athens, Georgia, United States of America, College of Veterinary Medicine, University of Georgia, Athens, Georgia, United States of America
Published: January 13, 2015
DOI: 10.1371/journal.pbio.1002056
Abstract
In 2014, a major epidemic of human Ebola virus disease emerged in West Africa, where human-to-human transmission has now been sustained for greater than 12 months. In the summer of 2014, there was great uncertainty about the answers to several key policy questions concerning the path to containment. What is the relative importance of nosocomial transmission compared with community-acquired infection? How much must hospital capacity increase to provide care for the anticipated patient burden? To which interventions will Ebola transmission be most responsive? What must be done to achieve containment?

In recent years, epidemic models have been used to guide public health interventions. But, model-based policy relies on high quality causal understanding of transmission, including the availability of appropriate dynamic transmission models and reliable reporting about the sequence of case incidence for model fitting, which were lacking for this epidemic.

To investigate the range of potential transmission scenarios, we developed a multi-type branching process model that incorporates key heterogeneities and time-varying parameters to reflect changing human behavior and deliberate interventions in Liberia. Ensembles of this model were evaluated at a set of parameters that were both epidemiologically plausible and capable of reproducing the observed trajectory. Results of this model suggested that epidemic outcome would depend on both hospital capacity and individual behavior. Simulations suggested that if hospital capacity was not increased, then transmission might outpace the rate of isolation and the ability to provide care for the ill, infectious, and dying. Similarly, the model suggested that containment would require individuals to adopt behaviors that increase the rates of case identification and isolation and secure burial of the deceased.
As of mid-October, it was unclear that this epidemic would be contained even by 99% hospitalization at the planned hospital capacity. A new version of the model, updated to reflect information collected during October and November 2014, predicts a significantly more constrained set of possible futures. This model suggests that epidemic outcome still depends very heavily on individual behavior. Particularly, if future patient hospitalization rates return to background levels (estimated to be around 70%), then transmission is predicted to remain just below the critical point around Reff = 1. At the higher hospitalization rate of 85%, this model predicts near complete elimination in March to June, 2015.

Author Summary
There is considerable uncertainty regarding the steps needed to contain the ongoing Ebola crisis in West Africa, the timeline required to achieve control, and the projected burden of mortality. To address these issues, we develop a branching process model for Ebola transmission that focuses on offspring distributions (i.e., the numbers of new infections caused by each case). We use the model to assess the likely progression of Ebola in Liberia. The model assesses the feedback between new cases and hospital demand under a range of plausible intervention scenarios, particularly ramping-up of treatment facilities over time and increasing the number of individuals seeking hospital treatment through outreach and education. Transmission scenarios—to health care workers in hospitals, to caregivers in the community, to hospital visitors, and to individuals preparing bodies for funerals—are described by distinct offspring distributions based on available data. Results suggest that the outcome of the epidemic depends on both hospital capacity and individual behavior. Additionally, the model highlights the conditions under which transmission might have outpaced hospital capacity, and projects possible epidemic trajectories into 2015.

Draft road map for Ebola vaccine development [Team B]

Draft road map for Ebola vaccine development [Team B]
12 January 2015
Wellcome Trust, Centre for Infectious Disease Research and Policy (CIDRAP)

A draft road map for the expedited development, testing, manufacture, delivery and financing of Ebola vaccines has today been published by a global group of experts supported by the Wellcome Trust.

The development and delivery of safe and effective vaccines would make a huge contribution to containing Ebola in Guinea, Liberia and Sierra Leone, as well as improving responses to future outbreaks and providing a model for vaccine development against other emerging infectious disease, the expert group has concluded.

The panel of 26 international experts, convened by the and the Centre for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, explains how the substantial scientific, financial, social and logistical challenges to rapid Ebola vaccine development and deployment can be overcome through collaboration between governments, industry and philanthropic bodies.

It highlights the potential need for multiple Ebola vaccines with different characteristics, which might enable different vaccination strategies such as ring-vaccination to prevent an outbreak from spreading, and prophylactic vaccination of high-risk individuals such as healthcare workers. It sets out the qualities that a successful vaccine should have and a set of principles for trial design.

The road map also emphasises the importance of community engagement so that vaccine trials and delivery programmes are positively received, and the need for such engagement campaigns to be adapted to national and local circumstances.

The recommendations are made in the interim report of Team B, which is co-chaired by Dr Jeremy Farrar, Director of the Wellcome Trust, and Professor Michael Osterholm, Director of CIDRAP. A full report will be published in the coming weeks, and the guidance will be a “living document” that evolves over time.

The group is called “Team B” in recognition of the principal role played by the World Health Organisation and national governments in leading the international Ebola response.

Dr Jeremy Farrar, Director of the Wellcome Trust and co-chair of Team B, said: “As Guinea, Liberia and Sierra Leone make encouraging progress in containing Ebola, we must not lose sight of the immense contribution that a safe and effective vaccine would make towards controlling both this and future epidemics. We need urgent global collaboration between governments, industry and philanthropy to ensure candidate vaccines progress through trials to manufacture and delivery as swiftly as possible.

“The draft road map we publish today, agreed by a global group of experts, offers solutions to the great scientific, social, logistical and financial challenges of delivering an Ebola vaccine on this urgent timescale. It is a living document that will evolve as we learn more about Ebola and the candidate vaccines that are available. As well as being of great value in the present crisis, it will enable vaccine strategies to begin without delay in future outbreaks, and provide a model for vaccine development in response to other emerging infectious diseases.”
The draft roadmap can be viewed here.

WHO & Regionals [to 17 January 2015]

WHO & Regionals [to 17 January 2015]

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:: 136th WHO Executive Board session
26 January–3 February 2015 –
– Main Documents: http://apps.who.int/gb/e/e_eb136.html

:: Global Alert and Response (GAR): Disease Outbreak News (DONs)
– Middle East respiratory syndrome coronavirus (MERS-CoV) – Oman 16 January 2015
– Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 15 January 2015

:: The Weekly Epidemiological Record (WER) for 16 January 2015, vol. 90, 3 (pp. 9–16) includes:
– Detection of influenza virus subtype A by polymerase chain reaction: WHO external quality assessment programme summary analysis, 2014

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WHO Regional Offices
WHO African Region AFRO
Press Releases
:: Safe breastfeeding key to improve children’s health
Brazzaville, 12 January 2015 – Every day an estimated 8000 children die in sub-Saharan Africa from easily preventable or treatable illnesses. Breastfeeding is one of the best ways to provide newborns, infants and young children with the nutrients that they need while protecting them against conditions such as pneumonia, diarrhoea, and measles.

:: A Decade of WHO Action in the African Region: Striving together to achieve health goals [pdf1.27MB ]
By Luis Gomes Sambo, Regional Director 2005–2015
ISBN: 978 929 023 2551

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WHO Region of the Americas PAHO
:: Isabella Danel, former CDC official, sworn in as PAHO/WHO Deputy Director (01/16/2015)

:: PAHO/WHO honors Haitians and international relief workers on 5th anniversary of 2010 earthquake
Port-au-Prince, Haiti, 12 January 2015 (PAHO/WHO) – On the fifth anniversary of the earthquake that devastated Haiti on 12 January 2010, the Pan American Health Organization/World Health Organization (PAHO/WHO) honors the earthquake’s estimated 230,000 victims and their families and pays tribute to the many Haitian health workers and international relief workers for their dedication and outstanding efforts to bring relief to the disaster’s victims and survivors…

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WHO South-East Asia Region SEARO
No new digest content identified.

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WHO European Region EURO
:: Tajikistan introduces rotavirus vaccine to protect children from diarrhoeal disease
15-01-2015
With an official launch ceremony on 8 January 2015, Tajikistan became the fourteenth country in the WHO European Region to introduce rotavirus vaccination into its national immunization schedule, and the fourth to do so through the generous support of the GAVI Alliance.

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WHO Eastern Mediterranean Region EMRO
:: One Year Since the Last Case of Polio In Syria
Friday, January 16, 2015
Despite civil war and mass population displacement, incredible gains have been made against the polio outbreak in the Middle East.

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WHO Western Pacific Region
:: Update on the cluster of HIV cases, Roka Commune, Sang Ker District, Battambang Province
PHNOM PENH, 9 January 2015 – Between 8 to 31 December, 2014, a total of 1940 people from Roka Commune, voluntarily undertook HIV testing and counselling and 212 people tested positive for HIV. Among the people who tested HIV positive, 174 (82%) are from Roka Village. Among the total of 212 diagnoses, 39 people (18%) are 14 years old or younger, 127 (60%) are between 15 and 59 years old and 46 (22%) are 60 years old or older.
Read the joint news release

CDC/MMWR Watch [to 17 January 2015]

CDC/MMWR Watch [to 17 January 2015]
http://www.cdc.gov/media/index.html

:: Protection from Flu Vaccination Reduced this Season – Press Release – Thursday, January 15, 2015

:: Early Estimates of Seasonal Influenza Vaccine Effectiveness — United States, January 2015
Weekly – January 16, 2015 / 64(01);10-15
Brendan Flannery, PhD1, Jessie Clippard, MPH1, Richard K. Zimmerman, MD2, Mary Patricia Nowalk, PhD2, Michael L. Jackson, PhD3, Lisa A. Jackson, MD3, Arnold S. Monto, MD4, Joshua G. Petrie, MPH4, Huong Q. McLean, PhD5, Edward A. Belongia, MD5, Manjusha Gaglani, MBBS6, LaShondra Berman, MS1, Angie Foust, MA1, Wendy Sessions, MPH1, Swathi N. Thaker, PhD1, Sarah Spencer, PhD1, Alicia M. Fry, MD1 (Author affiliations at end of text)
In the United States, annual vaccination against seasonal influenza is recommended for all persons aged ≥6 months (1). Each season since 2004–05, CDC has estimated the effectiveness of seasonal influenza vaccine in preventing medically attended acute respiratory illness (ARI) associated with laboratory-confirmed influenza. This season, early estimates of influenza vaccine effectiveness are possible because of widespread, early circulation of influenza viruses.
By January 3, 2015, 46 states were experiencing widespread flu activity, with predominance of influenza A (H3N2) viruses (2). This report presents an initial estimate of seasonal influenza vaccine effectiveness at preventing laboratory-confirmed influenza virus infection associated with medically attended ARI based on data from 2,321 children and adults enrolled in the U.S. Influenza Vaccine Effectiveness Network (Flu VE) during November 10, 2014–January 2, 2015. During this period, overall vaccine effectiveness (VE) (adjusted for study site, age, sex, race/ethnicity, self-rated health, and days from illness onset to enrollment) against laboratory-confirmed influenza associated with medically attended ARI was 23% (95% confidence interval [CI] = 8%–36%). Most influenza infections were due to A (H3N2) viruses. This interim VE estimate is relatively low compared with previous seasons when circulating viruses and vaccine viruses were well-matched and likely reflects the fact that more than two-thirds of circulating A (H3N2) viruses are antigenically and genetically different (drifted) from the A (H3N2) vaccine component of 2014–15 Northern Hemisphere seasonal influenza vaccines (2). These early, low VE estimates underscore the need for ongoing influenza prevention and treatment measures.
CDC continues to recommend influenza vaccination because the vaccine can still prevent some infections with the currently circulating A (H3N2) viruses as well as other viruses that might circulate later in the season, including influenza B viruses. Even when VE is reduced, vaccination still prevents some illness and serious influenza-related complications, including thousands of hospitalizations and deaths (3). Persons aged ≥6 months who have not yet been vaccinated this season should be vaccinated, including persons who might already have been ill with influenza this season…

:: MMWR Weekly, January 16, 2015 / Vol. 64 / No. 1
– Early Estimates of Seasonal Influenza Vaccine Effectiveness — United States, January 2015
– Incidence of Notifiable Diseases Among American Indians/Alaska Natives — United States, 2007–2011
– Improving Burial Practices and Cemetery Management During an Ebola Virus Disease Epidemic — Sierra Leone, 2014
– Use of a Nationwide Call Center for Ebola Response and Monitoring During a 3-Day House-to-House Campaign — Sierra Leone, September 2014

Sabin Vaccine Institute Watch [to 17 January 2015]

Sabin Vaccine Institute Watch [to 17 January 2015]
http://www.sabin.org/updates/pressreleases

India Launches Massive Public Health Campaign to Eliminate Lymphatic Filariasis
WASHINGTON, D.C. — January 14, 2015 — India was certified polio-free in 2014. Today, the country has its sights set on another public health victory: the elimination of lymphatic filariasis, a neglected tropical disease (NTD) that threatens nearly half of its population. To meet this ambitious goal, the Indian Ministry of Health & Family Welfare (MOHFW) has launched one of the largest public health campaigns in India’s history to provide more than 400 million people with free medication that could protect them from lymphatic filariasis…

Clinical Infectious Diseases (CID) – Volume 60 Issue 3 February 1, 2015

Clinical Infectious Diseases (CID)
Volume 60 Issue 3 February 1, 2015
http://cid.oxfordjournals.org/content/current

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A Case-Control Study to Estimate the Effectiveness of Maternal Pertussis Vaccination in Protecting Newborn Infants in England and Wales, 2012–2013
Clin Infect Dis. (2015) 60 (3): 333-337 doi:10.1093/cid/ciu82
Gavin Dabrera, Gayatri Amirthalingam, Nick Andrews, Helen Campbell, Sonia Ribeiro, Edna Kara, Norman K. Fry, and Mary Ramsay
Abstract
This case-control study demonstrated that maternal pertussis vaccination was highly effective in preventing laboratory-confirmed pertussis infection in infants aged <2 months during a national pertussis outbreak in England and Wales

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Editorial Commentary: Tetanus-Diphtheria-Pertussis Immunization in Pregnant Women and the Prevention of Pertussis in Young Infants
James D. Cherry
Author Affiliations
Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles

A case-control study from England and Wales on the effectiveness of tetanus-diphtheria-pertussis (Tdap) immunization in pregnant women, authored by Dabrera et al in this issue of Clinical Infectious Diseases, supports the finding of a previous observational study done by the same group of investigators [1, 2]. As noted by the authors, a single dose of Tdap was recommended in the United Kingdom for pregnant women between 28 and 38 weeks’ gestation in October 2012. In the United States, the Advisory Committee on Immunization Practices (ACIP) made a similar recommendation in October 2011.

One aspect of the UK experience with Tdap vaccination of pregnant women is noteworthy—that in England and Wales, pregnant women typically receive care by general practitioners, and these same practitioners are routinely responsible for immunization of all their patients. The present study was carried out between 22 October 2012 and 11 July 2013. Therefore, it was conducted over a 9-month period that started just 3 weeks after Tdap was recommended for pregnant women. Nevertheless, approximately 64% of the pregnant women were vaccinated.

In contrast with the experience in England and Wales, the Tdap program in the United States is struggling, even though it was recommended a full year before the recommendation was made in the United Kingdom [3, 4]. Both Harriman and Winter [4] and Housey et al [3 …

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Risk Assessment for Healthcare Workers After a Sentinel Case of Rabies and Review of the Literature
Virginia L. Kan, Patrick Joyce, Debra Benator, Kathleen Agnes, Janet Gill, Monica Irmler, Arlene Clark, George Giannakos, Audrey Gabourel, and Fred M. Gordin
Clin Infect Dis. (2015) 60 (3): 341-348 doi:10.1093/cid/ciu850
Abstract
Although there has been no human-to-human transmission, fear of contagion after a rabies case represents a major concern for healthcare workers and requires rapid risk screening and counseling, as well as timely provision of postexposure prophylaxis for those with high-risk exposure.

Editorial – Cervical Cancer 2015 and Beyond: A Focus on Innovative Treatments and Attention to Survivorship

Clinical Therapeutics
January 2015 Volume 37, Issue 1, p1-242
http://www.clinicaltherapeutics.com/current

Editorial
Cervical Cancer 2015 and Beyond: A Focus on Innovative Treatments and Attention to Survivorship
Linda R. Duska
p6–8
Cervical cancer is primarily a disease of less-developed countries.1 In contrast, for countries with established screening programs and access to medical care, the number of cases of cervical cancer has declined significantly over the past few decades. With the introduction of human papillomavirus (HPV) testing/typing and increasing uptake of the HPV vaccine, it is anticipated that HPV-related cervical disease (both preinvasive and invasive) will ultimately become obsolete in developed countries.

The critical impact of time-to-pandemic uncertainty on pandemic cost-effectiveness analyses

Health Policy and Planning
Volume 30 Issue 1 February 2015
http://heapol.oxfordjournals.org/content/current

Buy now, saved later? The critical impact of time-to-pandemic uncertainty on pandemic cost-effectiveness analyses
Tom Drake1,2,3,*, Zaid Chalabi1 and Richard Coker1,4
Author Affiliations
1London School of Hygiene and Tropical Medicine, Kepple Street, London, WC1E 7HT, UK, 2Nuffield Department of Clinical Medicine, University of Oxford, Old Road Campus, Oxford, OX3 7BN, UK, 3Mahidol University Rajvithi Road, Bangkok 10400, Thailand and 4National University of Singapore, Lower Kent Ridge Road, Singapore 119077
Accepted November 21, 2013.
Abstract
Background Investment in pandemic preparedness is a long-term gamble, with the return on investment coming at an unknown point in the future. Many countries have chosen to stockpile key resources, and the number of pandemic economic evaluations has risen sharply since 2009. We assess the importance of uncertainty in time-to-pandemic (and associated discounting) in pandemic economic evaluation, a factor frequently neglected in the literature to-date.
Methods We use a probability tree model and Monte Carlo parameter sampling to consider the cost effectiveness of antiviral stockpiling in Cambodia under parameter uncertainty. Mean elasticity and mutual information (MI) are used to assess the importance of time-to-pandemic compared with other parameters. We also consider the sensitivity to choice of sampling distribution used to model time-to-pandemic uncertainty.
Results Time-to-pandemic and discount rate are the primary drivers of sensitivity and uncertainty in pandemic cost effectiveness models. Base case cost effectiveness of antiviral stockpiling ranged between is US$112 and US$3599 per DALY averted using historical pandemic intervals for time-to-pandemic. The mean elasticities for time-to-pandemic and discount rate were greater than all other parameters. Similarly, the MI scores for time to pandemic and discount rate were greater than other parameters. Time-to-pandemic and discount rate were key drivers of uncertainty in cost-effectiveness results regardless of time-to-pandemic sampling distribution choice.
Conclusions Time-to-pandemic assumptions can “substantially” affect cost-effectiveness results and, in our model, is a greater contributor to uncertainty in cost-effectiveness results than any other parameter. We strongly recommend that cost-effectiveness models include probabilistic analysis of time-to-pandemic uncertainty.

Journal of Medical Internet Research – Vol 17, No 1 (2015) January

Journal of Medical Internet Research
Vol 17, No 1 (2015): January
http://www.jmir.org/2015/1

Virtual Intervention to Support Self-Management of Antiretroviral Therapy Among People Living With HIV
José Côté, Gaston Godin, Pilar Ramirez-Garcia, Geneviève Rouleau, Anne Bourbonnais, Yann-Gaël Guéhéneuc, Cécile Tremblay, Joanne Otis
J Med Internet Res 2015 (Jan 06); 17(1):e6

Application of Mobile Technology for Improving Expanded Program on Immunization Among Highland Minority and Stateless Populations in Northern Thailand Border
Jaranit Kaewkungwal, Tawatchai Apidechkul, Kasemsak Jandee, Amnat Khamsiriwatchara, Saranath Lawpoolsri, Surasak Sawang, Aumnuyphan Sangvichean, Peerawat Wansatid, Sarinya Krongrungroj
JMIR mHealth uHealth 2015 (Jan 14); 3(1):e4

The Lancet – Jan 17, 2015

The Lancet
Jan 17, 2015 Volume 385 Number 9964 p201-302
http://www.thelancet.com/journals/lancet/issue/current

Comment
Is the world ready for an Ebola vaccine?
Bruce Y Lee, William J Moss, Lois Privor-Dumm, Dagna O Constenla, Maria D Knoll, Katherine L O’Brien
Summary
The west African Ebola epidemic has motivated efforts to bring an Ebola vaccine to the market as soon as possible. If a candidate vaccine successfully moves through clinical development, a product could be on the market in the next 1–2 years.1–6 Developing an efficacious vaccine will be only part of the process. Post-licensure challenges could impede and even derail an Ebola immunisation programme. We propose seven key challenges to be considered early in Ebola vaccine development that will help stakeholders prepare and allow developers to adjust vaccine characteristics accordingly.

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Comment
Towards evidence-based, quantitative Sustainable Development Goals for 2030
Børge Brende, Bent Høie
Open Access
DOI: http://dx.doi.org/10.1016/S0140-6736(14)61654-8
The success of the Millennium Development Goals (MDGs)1 on health has been due to their being easy to understand, ambitious, and achievable and, therefore, suitable for the purposes of advocacy and political mobilisation. The MDGs have brought quantitative targets and measurement of results—previously the domain of the scientific community—to centre stage for politicians worldwide. The three health MDGs (MDG 4, MDG 5, and MDG 6) have acted as a scorecard to measure progress on health, thus providing an empirical basis for the formulation of policy. For example, this scorecard has made it possible for Norwegian Prime Minister Erna Solberg and her colleagues in the MDG Advocacy Group to provide such strong advocacy for continued efforts to reach the MDGs before the deadline of 2015.

Work on the health MDGs has been based throughout on close collaboration between the scientific and political communities. Politicians have been able to convey documented progress towards the goals to the general public, and voters in both donor and recipient countries alike have been happy to support public funding for these efforts.

The world community is currently negotiating a new set of goals—the Sustainable Development Goals (SDGs)—for the post-2015 period. So far, 17 goals and 169 targets have been proposed by the Open Working Group.2 For politicians this number of goals is far too many. To win popular support for a comprehensive and coordinated effort for development, the goals must be easy to communicate. With regard to health, we have faced the additional challenge of combining three goals into one SDG, with an attempt to put the whole range of health issues under one coherent goal. This process, in turn, has contributed to the present “shopping list” of 13 targets within the Open Working Group proposal for a goal on health (SDG 3): “ensure healthy lives and promote well-being for all at all ages”.

Of course, it is politics that led to such a long list of health targets in the first place, but ultimately it is politics that has to resolve this situation. Politicians have to set priorities. We need a more limited set of goals and targets that are ambitious, easy to understand, and realistic. Importantly, measurement of progress towards the goals and targets must also be possible. To this end, we need contributions from the scientific community.

One plausible way forward is shown in a Lancet study by Ole Norheim and colleagues3 on quantification of the overarching 2030 SDG for health to avoid 40% of premature deaths in each country. In their review of mortality rates and trends in 25 countries, four country income groupings, and worldwide, Norheim and colleagues show that it is possible to consolidate targets in various areas, such as child health (MDG 4), maternal health (MDG 5), major infectious diseases (MDG 6), non-communicable diseases (NCDs), including mental health and injuries, and universal health coverage, under one universal and quantitative health goal. The simplicity of this approach is beautiful. Following this pattern, we could develop a tool to measure convergence in health globally, in line with the principle of universality to which we are all committed.

This approach seems to make sense from a scientific point of view as well. The proposal to set an overall indicator of avoiding 40% of premature deaths in each country is based on trends in mortality rates over the past 40 years and an estimate of what can be achieved by scaling up current cost-effective approaches. This quantification of a goal on health includes the major targets relating to MDGs 4, 5, and 6 and targets on NCDs proposed by the various communities, notably a 25% reduction in premature mortality from NCDs by 2025. This indicator is evidence based and ambitious yet achievable. It is, therefore, a good starting point for future political action and initiative.

Norheim and colleagues’ study3 shows what an important part science could play in the negotiations at the 69th Session of the UN General Assembly. We, therefore, strongly urge the medical community to consider the approach outlined by Norheim and colleagues3 and develop a common position that can enable us to arrive at a single health SDG with a limited number of simple, understandable, and measurable targets. We would also welcome similar approaches for other SDGs by the relevant communities.

We believe that the health SDG could provide the key framework for global health and prosperity. In anticipation of this framework, Norway is already taking concrete action. First, we are taking steps to improve public health in Norway. Our aim is to reduce NCDs, including mental disorders, by 25% by 2025. Second, Norway is working together with partner nations, the UN Secretary-General Ban Ki-moon, and World Bank President Jim Yong Kim to develop financial frameworks both for the current MDGs and for the future SDGs. Third, Norway is actively promoting projects that focus on both education and health, reflecting the aim of the SDG agenda of realising synergies between sectors.

Fourth, later in September, 2014, we will launch a national initiative called Vision 2030 to encourage researchers, commercial actors, civil society, and others to produce innovative ideas that could play a part in achieving the education and health SDGs both in Norway and abroad. Finally, together with partners in global health, Norway will explore ways to accelerate the deployment of innovations that are currently in the pipeline, and how investments can be catalysed to harness these innovations for promoting global health in the longer term.4
With so much left to do in the field of global health, by scientists as well as politicians, there is no time to lose. It is, therefore, vital that we all take action now.
BB is Norwegian Minister of Foreign Affairs. BH is Norwegian Minister of Health and Care Services.

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Comment
Quantifying targets for the SDG health goal
George Alleyne, Robert Beaglehole, Ruth Bonita
Open Access
DOI: http://dx.doi.org/10.1016/S0140-6736(14)61655-X
Summary
The Millennium Development Goals (MDGs) represent the best example of an international commitment to a set of normative principles underpinned by ideals of equity, solidarity, and peace.1,2 The goals achieved universal support because they were ambitious, included indicators that permitted measurement and accountability, and set 2015 for final reporting. The goals institutionalised poverty as multidimensional, and shaped development as beyond economics.3 Criticisms of the MDGs included the omission of many of the concerns of the Millennium Declaration, and the lack of adequate consultation on the process.

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Articles
Avoiding 40% of the premature deaths in each country, 2010–30: review of national mortality trends to help quantify the UN Sustainable Development Goal for health
Prof Ole F Norheim, PhD, Prof Prabhat Jha, DPhil, Kesetebirhan Admasu, MD, Tore Godal, MD, Ryan J Hum, MEng, Margaret E Kruk, MD, Octavio Gómez-Dantés, MD, Colin D Mathers, PhD, Hongchao Pan, PhD, Prof Jaime Sepúlveda, MD, Wilson Suraweera, MSc, Stéphane Verguet, PhD, Addis T Woldemariam, MD, Gavin Yamey, MD, Prof Dean T Jamison, PhD, Prof Richard Peto, FRS
Open Access
DOI: http://dx.doi.org/10.1016/S0140-6736(14)61591-9
Summary
Background
The UN will formulate ambitious Sustainable Development Goals for 2030, including one for health. Feasible goals with some quantifiable, measurable targets can influence governments. We propose, as a quatitative health target, “Avoid in each country 40% of premature deaths (under-70 deaths that would be seen in the 2030 population at 2010 death rates), and improve health care at all ages”. Targeting overall mortality and improved health care ignores no modifiable cause of death, nor any cause of disability that is treatable (or also causes many deaths). 40% fewer premature deaths would be important in all countries, but implies very different priorities in different populations. Reinforcing this target for overall mortality in each country are four global subtargets for 2030: avoid two-thirds of child and maternal deaths; two-thirds of tuberculosis, HIV, and malaria deaths; a third of premature deaths from non-communicable diseases (NCDs); and a third of those from other causes (other communicable diseases, undernutrition, and injuries). These challenging subtargets would halve under-50 deaths, avoid a third of the (mainly NCD) deaths at ages 50–69 years, and so avoid 40% of under-70 deaths. To help assess feasibility, we review mortality rates and trends in the 25 most populous countries, in four country income groupings, and worldwide.
Methods
UN sources yielded overall 1970–2010 mortality trends. WHO sources yielded cause-specific 2000–10 trends, standardised to country-specific 2030 populations; decreases per decade of 42% or 18% would yield 20-year reductions of two-thirds or a third.
Results
Throughout the world, except in countries where the effects of HIV or political disturbances predominated, mortality decreased substantially from 1970–2010, particularly in childhood. From 2000–10, under-70 age-standardised mortality rates decreased 19% (with the low-income and lower-middle-income countries having the greatest absolute gains). The proportional decreases per decade (2000–10) were: 34% at ages 0–4 years; 17% at ages 5–49 years; 15% at ages 50–69 years; 30% for communicable, perinatal, maternal, or nutritional causes; 14% for NCDs; and 13% for injuries (accident, suicide, or homicide).
Interpretation
Moderate acceleration of the 2000–10 proportional decreases in mortality could be feasible, achieving the targeted 2030 disease-specific reductions of two-thirds or a third. If achieved, these reductions avoid about 10 million of the 20 million deaths at ages 0–49 years that would be seen in 2030 at 2010 death rates, and about 17 million of the 41 million such deaths at ages 0–69 years. Such changes could be achievable by 2030, or soon afterwards, at least in areas free of war, other major effects of political disruption, or a major new epidemic.
Funding
UK Medical Research Council, Norwegian Agency for Development Cooperation, Centre for Global Health Research, and Bill & Melinda Gates Foundation.

The African Genome Variation Project shapes medical genetics in Africa

Nature
Volume 517 Number 7534 pp244-406 15 January 2015
http://www.nature.com/nature/current_issue.html

The African Genome Variation Project shapes medical genetics in Africa
Open
Deepti Gurdasani, Tommy Carstensen, Fasil Tekola-Ayele, Luca Pagani, Ioanna Tachmazidou
+ et al.
The African Genome Variation Project contains the whole-genome sequences of 320 individuals and dense genotypes on 1,481 individuals from sub-Saharan Africa; it enables the design and interpretation of genomic studies, with implications for finding disease loci and clues to human origins.

New England Journal of Medicine – January 15, 2015

New England Journal of Medicine
January 15, 2015 Vol. 372 No. 3
http://www.nejm.org/toc/nejm/medical-journal

Sharing Individual Patient Data from Clinical Trials
Jeffrey M. Drazen, M.D.
N Engl J Med 2015; 372:201-202January 15, 2015DOI: 10.1056/NEJMp1415160
Free Full Text, Audio, Comments

Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs
J.J. Darrow, A. Sarpatwari, J. Avorn, and A.S. Kesselheim
The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access.

Considerations on the Current Universal Vaccination Policy against Hepatitis A in Greece after Recent Outbreaks

PLoS One
[Accessed 17 January 2015]
http://www.plosone.org/

Considerations on the Current Universal Vaccination Policy against Hepatitis A in Greece after Recent Outbreaks
Kassiani Mellou, Theologia Sideroglou, Vassiliki Papaevangelou, Anna Katsiaflaka, Nikolaos Bitsolas, Eleni Verykouki, Eleni Triantafillou, Agoritsa Baka, Theano Georgakopoulou, Christos Hadjichristodoulou
Research Article | published 15 Jan 2015 | PLOS ONE 10.1371/journal.pone.0116939

The Ebola Epidemic: High hopes for Guinean vaccine trial

Science
16 January 2015 vol 347, issue 6219, pages 209-348
http://www.sciencemag.org/current.dtl

The Ebola Epidemic
High hopes for Guinean vaccine trial
Martin Enserink*
The push to test Ebola vaccines in the field is accelerating. Two candidates may go into phase III trials in a matter of weeks; a third one has just entered a phase I trial. Researchers have designed very different phase III studies for Liberia, Sierra Leone, and Guinea, the three countries with ongoing virus transmission. One problem they’re facing is that the number of new cases has dropped sharply in Liberia and is beginning to ebb in Sierra Leone. That’s why many scientists say Guinea—where researchers plan to try a highly unusual ring vaccination design—is the most promising testing ground.

Pediatricians’ Preferences for Infant Meningococcal Vaccination

Value in Health
January 2015 Volume 18, Issue 1, p1-136
http://www.valueinhealthjournal.com/current

Pediatricians’ Preferences for Infant Meningococcal Vaccination
Christine Poulos, PhD, F. Reed Johnson, PhD, Girishanthy Krishnarajah, MBA, MPH, Andrea Anonychuk, MSc, Derek Misurski, PhD
DOI: http://dx.doi.org/10.1016/j.jval.2014.10.010
Abstract
Background
Meningococcal disease is rare but can cause death or disabilities. Although the Advisory Committee on Immunization Practices has recommended meningococcal vaccination for at-risk children aged 9 through 23 months, it has not endorsed universal vaccination. Health insurance payments for the vaccination of children who are not at risk are likely to be limited. Use of infant meningococcal vaccines by these families will thus depend on the preferences of physicians who might recommend vaccination to parents, as well as parents’ preferences.
Objective
To quantify pediatricians’ preferences for specific features of hypothetical infant meningococcal vaccines.
Methods
A sample of pediatricians (n = 216) completed a Web-enabled, discrete choice experiment survey in which respondents chose between pairs of hypothetical vaccines in a series of trade-off questions. The questions described vaccines with six attributes. A random-parameters logit regression model was used to estimate the relative importance weights physicians place on vaccine features. These weights were used to calculate the predicted probability that a physician chooses hypothetical vaccines with given characteristics.
Results
Pediatricians’ choices indicated that increases in vaccine effectiveness were among the most important factors in their vaccine recommendations, followed by increases in the number of injections. The age at which protection begins and the number of additional office visits were less important. Whether a booster was required after 5 years was the least important factor in vaccine recommendations. The results suggest that virtually all (99.9%) physicians in the sample would recommend a vaccine even with the least-preferred features rather than no infant meningococcal vaccine.
Conclusions
Physicians’ responses indicate a strong preference for infant meningococcal vaccination.

From Google Scholar+ [to 17 January 2015]

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

Revista de Saude Publica
Oct 2014; 48(6): 906–915.
doi: 10.1590/S0034-8910.2014048005284
Factors associated with vaccination coverage in children< 5 years in Angola
Manuel Falcão Saturnino de Oliveira, I Edson Zangiacomi Martinez, II and Juan Stuardo Yazlle Rocha
Abstract
OBJECTIVE
To analyze vaccination coverage and factors associated with a complete immunization scheme in children < 5 years old.
METHODS
This cross-sectional household census survey evaluated 1,209 children < 5 years old living in Bom Jesus, Angola, in 2010. Data were obtained from interviews, questionnaires, child immunization histories, and maternal health histories. The statistical analysis used generalized linear models, in which the dependent variable followed a binary distribution (vaccinated, unvaccinated) and the association function was logarithmic and had the children’s individual, familial, and socioeconomic factors as independent variables.
RESULTS
Vaccination coverage was 37.0%, higher in children < 1 year (55.0%) and heterogeneous across neighborhoods; 52.0% of children of both sexes had no immunization records. The prevalence rate of vaccination significantly varied according to child age, mother’s level of education, family size, ownership of household appliances, and destination of domestic waste.
CONCLUSIONS
Vulnerable groups with vaccination coverage below recommended levels continue to be present. Some factors indicate inequalities that represent barriers to full immunization, indicating the need to implement more equitable policies. The knowledge of these factors contributes to planning immunization promotion measures that focus on the most vulnerable groups.

Media/Policy Watch [to 17 January 2015]

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

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

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Forbes
http://www.forbes.com/
Accessed 17 January 2015
Gates Foundation CEO: “History Is Going To Judge Us”
Sue Desmond-Hellmann took the helm at The Bill & Melinda Gates Foundation last May. She talks about what she’s hoping to change and how working in Uganda informs what she does now.
Kerry A. Dolan, Forbes Staff Jan 16, 2015
Gates Foundation CEO: A Picture Of Hope In Early Ebola Vaccine Trials
Efforts to develop vaccines for Ebola are moving more quickly than usual for this kind of disease, says The CEO of The Bill & Melinda Gates Foundation.
Kerry A. Dolan, Forbes Staff Jan 12, 2015

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New Yorker
http://www.newyorker.com/
Accessed 17 January 2015
Surviving Ebola
16 January 2015
In West Africa , people who catch Ebola and do not die are called “survivors…

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Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 17 January 2015
Study of Ebola Drug ZMapp Set for West Africa
17 January 20215
A clinical trial of the experimental Ebola drug ZMapp may be ready to get under way in infected patients in West Africa in February, the latest effort to combat the current epidemic and any future outbreaks.

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Washington Post
http://www.washingtonpost.com/
Accessed 17 January 2015
Editorial –The Post’s View
The United States should generously support Gavi’s immunization efforts
The Washington Post | 11 January 2015
AN IMPORTANT conference is to be held in Berlin on Jan. 27 to secure financial replenishment for Gavi, the Vaccine Alliance, a multilateral nonprofit that for 15 years has been bringing vaccines to children in the world’s 73 poorest nations. Many attendees will be watching to see what the United States pledges to the effort for the next few years. It ought to be generous…

Ebola/EVD: Additional Coverage [to 17 January 2015]

Ebola/EVD: Additional Coverage

UNMEER [UN Mission for Ebola Emergency Response] @UNMEER #EbolaResponse

Editor’s Note: UNMEER’s website is aggregating and presenting content from various sources including its own External Situation Reports, press releases, statements and other formats.

We present a composite below from the week ending 17 January 2015. We also note that 1) a regular information category in these reports – human rights – has apparently eliminated as it no longer appears in any of the continuing updates, and 2) the content level of these reports continues, in our view, to trend less informative and less coherent. We will review continuing coverage of this material over the next few weeks.

UNMEER External Situation Reports
UNMEER External Situation Reports are issued daily (excepting Saturday) with content organized under these headings:
– Highlights
– Key Political and Economic Developments
– Human Rights
– Response Efforts and Health
– Logistics
– Outreach and Education
– Resource Mobilisation
– Essential Services
– Upcoming Events

The “Week in Review” will present highly-selected elements of interest from these reports. The full daily report is available as a pdf using the link provided by the report date.

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:: 16 Jan 2015 UNMEER External Situation Report
Response Efforts and Health
2. In Sierra Leone, the UNICEF-led Family Tracing and Reunification (FTR) network have identified 15,258 children as being directly affected by the Ebola crisis (7,664 girls and 7,594 boys), with 7,968 children having lost one or both parents to Ebola and 552 unaccompanied or separated from their caregiver. 9,103 Ebola-affected children have been provided with psychosocial support.
8. The OCHA Ebola Virus Outbreak Overview of Needs and Requirements, now totaling USD 1.5 billion, has been funded for USD 1.15 billion, which is around 77% of the total ask.
Essential Services
13. The guidelines for the reopening of schools in February was shared with educational authorities in Sinoe County, Liberia. The schools need to establish a committee to oversee the implementation of the guidelines, register the students and identify people trained in IPC procedures. Medical Team International (MTI) offered to distribute the guidelines to the schools. UNICEF will provide three thermoflashes per school to 220 schools. Among the challenges and issues in instituting the guidelines are: 1) the lack of personnel to implement them in the schools (some schools have one teacher for 100 students); 2) the inaccessibility of some schools due to their remote location; 3) lack of basic equipment like printers and photocopiers to disseminate the guidelines; and 4) lack of clarity on no-touch policy for people caring for children under 3-years-old (it may not be possible to institute the policy in these cases). The general community health volunteers (gCHVs) plan to support the schools in some locations.
14. Preparations are underway for a second mass distribution of anti-malaria treatments in Ebola hotspots in Sierra Leone. An estimated 2.5 million are expected to be reached in the coming

:: 15 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. According to press reports, President Ernest Bai Koroma of Sierra Leone predicted while visiting Port Loko, Tonkolili and Bombali in the northern District that his country would be Ebola-free by May.
2. In Forécariah, Kindia Prefecture, Guinea, following the lynching of two police officers and a driver by the local population on 17 January, tension remains high. Evaluation team for the campaign “Zero Ebola in 60 days” reported that several villages were currently inaccessible due to the heightened tension.

:: 14 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. UNDP is leading an Early Recovery Assessment mission in the three most affected countries. The mission includes representatives from the World Bank, the African Development Bank, the European Union and UN agencies. In Liberia, the mission met with President Ellen Johnson-Sirleaf, as well as with Ministers and Deputy Ministers, the Governance Commission, Land Commission, Civil Services Agency and the leadership of the IMS and UNMEER. The mission is today in Sierra Leone and will then travel to Guinea before compiling a plan for early recovery in the three most affected countries.
2. The Islamic Development Bank (IDB), has announced financing in the amount of USD 35 million to countries affected by Ebola.
Response Efforts and Health
3. Health workers have been paid across Liberia in a coordinated effort led by the Ministry of Health and supported by UNDP and UNMEER. In total, more than USD 1 million in cash was distributed to thousands of workers, with Ministry of Health, Ministry of Finance and UNDP staff travelling to remote areas over the past six days. Logistics assistance was provided by WFP and UNMEER, as well as the County Health Teams. The Ministry is now collecting data from the field and will report on final numbers this week.
6. As of last week, the number of children in Liberia registered as orphaned due to EVD is 4,372. All of the children identified are currently receiving follow-up and psychosocial support. The Child Protection Sub-Cluster estimates that there can be as many as 7,500 Ebola orphans in Liberia. UNICEF is partnering with the government and NGOs to train and engage more social workers to identify and ensure that all the orphans are in an adequately protective environment.

:: 13 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
3. Two new World Bank reports indicate that the socio-economic impacts of Ebola in Liberia and Sierra Leone are far-reaching and persistent. Both countries continue to experience job losses, despite their differing health outlooks. These impacts have not been limited to the areas where infections have been the highest, which points to economy-wide slowdowns. As a result, many households have been forced to take short-term actions to cope, which can have substantial long-term effects on welfare.
Outreach and Education
14. UNICEF, in partnership with the Monrovia and Paynesville city councils, Liberia launched Operation Stop Ebola – a mass media, community outreach and engagement campaign targeting 900,000 people or about 80 percent of the population of Montserrado County. To this end, 170 commissioners, governors and community leaders have been trained.
15. In Sierra Leone, social mobilizers from various agencies mobilized 782 religious leaders and 2,077 community leaders and reached 11,003 households to inform them about improvements in services and to mobilize people to seek early care and treatment. The intensification resulted in an increase in number of calls to the 117 hotline to report sick or suspected cases or to seek information and care. It also led to an increase in ‘walk-ins’ and

:: 12 Jan 2015 UNMEER External Situation Report
Response Efforts and Health
3. WFP has finalised the rehabilitation of a hospital in Kambia, Sierra Leone, to be managed by Partners in Health (PiH). This hospital will be used as a Holding Centre with 40 beds and on 9 January was officially inaugurated by President Ernest Bai Koroma. WFP has the capacity to provide additional necessary equipment and staff to support the construction of additional wings at the hospital; this Centre could be extended to become an Ebola Treatment Unit (ETU) with a capacity to hold up to 100 beds, by erecting an additional 10m x 24m Mobile Storage Unit (MSU).

Vaccines and Global Health: The Week in Review 10 January 2015

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

.Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_10 January 2015

blog edition: comprised of the approx. 35+ entries posted below on this date.

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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Support:  If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary, and follow the relevant steps . Thank you…

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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

POLIO [to 10 January 2015]

POLIO [to 10 January 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 7 January 2014
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: The last few years have seen the Global Polio Eradication Initiative (GPEI) evolve and grow in response to the threats posed to the world by the final strongholds of the poliovirus. Despite being more geographically limited than ever before, at the end of 2014 the virus continues to pose challenges that must be faced in 2015 if we are to protect children from this disease forever. Polio eradication efforts in 2015 will have five priorities: refining surveillance to catch any remaining virus, keeping Africa and the Middle East polio-free, providing a surge of support to Pakistan and Afghanistan, preparing for the withdrawal of oral polio vaccine type 2 and continuing to demonstrate and build on the differences that the polio programme makes to strengthen routine immunization programmes. More

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Selected country report content:
Afghanistan
:: Two new wild poliovirus type 1 (WPV1) cases were reported in the past two weeks in Panjwayi district of Kandahar province. The most recent case had onset of paralysis on 4 December. The total number of WPV1 cases for 2014 in Afghanistan is now 28 compared to 14 in 2013. The bulk of these cases are linked to cross-border transmission with neighbouring Pakistan.
:: Subnational Immunization Days (SNIDs) are planned for 11 – 13 and 25 – 27 January in high risk areas of the south and east using bivalent oral polio vaccine (OPV). On 15 – 17 February, SNIDs will take place across the entire south of the country, also using bivalent OPV. The next National Immunization Days (NIDs) are planned for March using a combination of inactivated polio vaccine (IPV) and trivalent OPV.
Nigeria
:: One new type 2 circulating vaccine-derived poliovirus (cVDPV2) case was reported in the last week. This most recent case had onset of paralysis on 16 November in Barde district of Yobe state. The total number of cVDPV2 cases for 2014 in Nigeria is now 29.
Pakistan
:: Six new wild poliovirus type 1 (WPV1) cases were reported in the past 2 weeks. Two are from Balochistan (1 in Killa Abdullah district and the other in newly infected Chaghai district); 2 from Khyber Pakhtunkhwa (KP) province, both in Peshawar; and 2 from the Federally Administered Tribal Areas (FATA) in Khyber Agency. The total number of WPV1 cases in Pakistan in 2014 is now 297, compared to 93 in 2013. The most recent WPV1 cases had onset of paralysis on 15 December in Khyber Agency.
:: Immunization activities are continuing with particular focus on known high-risk areas, in previously inaccessible areas of FATA. At exit and entry points of conflict-affected areas 100 permanent vaccination points are being used to reach internally displaced families as they move in and out of the inaccessible area.
West Africa
:: The Ebola crisis in western Africa continues to have an impact on the implementation or polio eradication activities in Liberia, Guinea and Sierra Leone. Supplementary immunization activities (SIAs) in these countries have been postponed and the quality of acute flaccid paralysis surveillance has markedly decreased this year. National Immunization Days (NIDs) have been rescheduled for Guinea, Liberia and Sierra Leone from the 27 February to 31 March. The programme continues to monitor the situation with concern.
:: Even as polio programme staff across West Africa support efforts to control the Ebola outbreak affecting the region, efforts are being made in those countries not affected by Ebola to vaccinate children against polio to create a buffer zone surrounding the Ebola-affected countries.
:: NIDs are planned using bivalent oral polio vaccine (OPV) in Niger and Benin on 27 February to 2 March, and tentatively in Mali in March with dates to be confirmed. From the 27 to 31 March, NIDs will take place in Benin, Burkina Faso, Cote d’Ivoire, Mali, Niger and Senegal using trivalent OPV.

EBOLA/EVD [to 10 January 2015]

EBOLA/EVD [to 10 January 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Editor’s Note:
Our extensive coverage of Ebola/EVD activity continues – including detailed coverage of UNMEER now available at the end of this digest and other INGO/agency activity reported in the relevant sections below. Please also note that many of the journals we cover continue to publish important EVD content which is threaded throughout this edition.

Important this week was a milestone WHO meeting on EVD vaccine candidates and new clinical trials to begin in the most affected countries shortly as reported below.

We also note that the WHO Situation Report below clarifies that the “100% goals” for 1 January 2015 were not met. We are not aware that these goals (or revised/additional goals) with a new date target have been announced.

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Ban Ki-moon on his priorities for 2015 – General Assembly, Informal meeting of the plenary – 8 Jan 2014
– Video: http://webtv.un.org/watch/ban-ki-moon-on-his-priorities-for-2015-general-assembly-informal-meeting-of-the-plenary/3978253934001
– Text: http://www.un.org/sg/statements/index.asp?nid=8312
Excerpt on Ebola

…The outbreak of Ebola in West Africa has been a human tragedy and a setback for development in the hardest hit countries, and has highlighted the need for global vigilance and solidarity.

I thank the General Assembly for its unprecedentedly rapid action to establish UNMEER, the UN Mission for Ebola Emergency Response. The affected countries are beginning to see some improvements, thanks to their own mobilization and global support. Mali has made progress in controlling the virus, and we hope that Mali will be declared Ebola-free this month.

I have been especially moved by the deployment of health workers from many African countries and other parts of the world. But, Excellencies, we are still short of people and resources. As we strive to fill those gaps, we also need to address the wider impacts and to meet recovery needs.

We must also prepare for any possible new epidemic, wherever it may occur. Strengthening national health systems is a priority. International rapid response capacities must be improved. In that regard, I support the efforts of the World Health Organization led by Dr. Margaret Chan, to begin work on the way forward….

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WHO: Ebola response roadmap – Situation report 7 January 2015
[Excerpt]
Summary
:: Reported case incidence continues to fluctuate in Guinea, with no identifiable downward trend. Ebola virus disease (EVD) continues to spread geographically within the country, with the prefecture of Fria reporting 2 confirmed cases for the first time. Case incidence has declined to low levels in Liberia. There are signs that incidence has levelled off in Sierra Leone, although transmission remains intense in the west of the country.

:: The UN Mission for Ebola Emergency Response (UNMEER) set twin targets of isolating and treating 100% of EVD cases, and conducting 100% of burials safely and with dignity by 1 January, 2015, in Guinea, Liberia, and Sierra Leone.

:: Each of the intense-transmission countries has sufficient capacity to isolate and treat patients, with more than 2 treatment beds per reported confirmed and probable case. However, the uneven geographical distribution of beds and cases, and the under-reporting of cases, means that the UNMEER target of isolating and treating 100% of EVD cases is still not met in some areas. An increasing emphasis will be put on the rapid deployment of smaller treatment facilities to ensure that capacity is matched with demand in each area.

:: Similarly, each country has sufficient capacity to bury all people known to have died from EVD, though the under-reporting of deaths means that the UNMEER target of 100% safe burial was not met.

:: In addition to the two UNMMER targets, there are several other crucial aspects of the response, including rigorous contact tracing, access to laboratory services, and community engagement.

:: Guinea, Liberia and Sierra Leone report that more than 90% of registered contacts are monitored, though the number of contacts traced per EVD case remains lower than expected in many districts. In areas where transmission has been driven down to low levels, rigorous contact tracing will be essential to break chains of transmission.

:: There are currently 23 laboratories providing case-confirmation services in the three intense-transmission countries. Five more laboratories are planned in order to meet demand.

:: Case fatality among hospitalized patients (calculated from all hospitalized patients with a reported definitive outcome) is approximately 60% in the three intense-transmission countries.
:: A total of 820 health-care worker infections have been reported in the intense-transmission countries; there have been 488 deaths.

:: Many elements of the response to the EVD outbreak, from safe burials to contact tracing, rely on actively engaging affected communities to take ownership of the response. UNICEF leads the community engagement arm of the EVD response. At present, 33 of 38 (87%) of districts in Guinea, 100% of districts in Liberia, and 57% (8 of 14) of districts in Sierra Leone have systems in place to monitor community engagement activities.

1. COUNTRIES WITH WIDESPREAD AND INTENSE TRANSMISSION
There have been in excess of 20,000 confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (table 1), with more than 8,000 deaths (deaths are under-reported).

A stratified analysis of cumulative confirmed and probable cases indicates that the number of cases in males and females is about the same (table 2).

Compared with children (people aged 14 years and under), people aged 15 to 44 are three times more likely to be affected (33 reported cases per 100 000 population, compared with 98 per 100,000 population). People aged 45 and over (125 reported cases per 100 000 population) are almost four times more likely to be affected than are children.

There have been 26 reported confirmed and probable cases per 100,000 population in Guinea, 206 cases per 100,000 population in Liberia, and 170 cases per 100,000 population in Sierra Leone…

WHO: Second high-level meeting on Ebola vaccines access and financing – 8 January 2015

WHO: Second high-level meeting on Ebola vaccines access and financing
Date: 8 January 2015
Place: Geneva, Switzerland
About the meeting
On 8 January 2015, WHO will convene the second high-level meeting on Ebola vaccines access and financing. The meeting will review the current status of clinical trials of Ebola vaccines and plans for Phase II and Phase III efficacy trials. ‘

Also on the agenda are discussion of funding mechanisms for potential Ebola vaccine introduction and the process for decision-making on introduction beyond Phase III trials. This meeting is a follow-up to the First high-level meeting on Ebola vaccines access and financing held on 23 October 2014.
Participants of the meeting

The meeting will be chaired by Professor Helen Rees, University of Witwatersrand and Co-Chair of the SAGE Ebola Vaccine Working Group. Participants include representatives from manufacturers and research institutions that are currently developing or testing Ebola candidate vaccines, government officials from the Ebola-affected and neighbouring countries, and nongovernmental organizations and partners.

Meeting documents
Agenda of the meeting
pdf, 266kb
List of participants
pdf, 120kb

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WHO Director-General opens high-level meeting on Ebola vaccines
8 January 2015
Distinguished experts,
Good morning and welcome to this second high-level meeting on Ebola vaccines access and financing. I thank you again for giving us your expertise and your time.

I will be brief. You have given yourselves some very tight deadlines and are moving ahead quickly. In fact, what you are doing is unprecedented: compressing into a matter of months work that normally takes 2 to 4 years, yet with no compromise of international standards of safety and efficacy.

We are here to take stock, plan the next steps, and make sure that all partners are working in tandem. We all want the momentum and sense of urgency to continue. We want to spot potential bottlenecks early and iron out any difficulties that could slow things down. Even the highest ambitions become feasible with determination and good planning.

Previous experts agreed that vaccines will have an impact on the Ebola epidemic in any future scenario, whether worst-case or best-case. I see no indication that this view has changed.

In terms of the dynamics of the outbreaks in Guinea, Liberia, and Sierra Leone, last year did not end with a best-case scenario. Too many health care workers are still getting infected, including nationals and doctors and nurses from foreign medical teams.

The situation in Liberia looks far more promising than it did in October and November, with cases showing a persistent decline and smaller geographical distribution. But transmission in Monrovia continues, with cases scattered throughout the city, making it difficult to identify distinct transmission chains. Many believe that the virus has moved from the cities into extremely remote rural areas, making it difficult to see what is really happening in Liberia.
Sierra Leone has now outstripped Liberia as the worst-affected country. Several hundred cases are being reported each week.

During the third week in December, Guinea reported nearly 160 confirmed cases, the highest weekly case incidence in the year-long history of the outbreak there.

The wide geographical dispersion of cases remains a problem. Whereas only 7 prefectures reported cases in October, that number had grown to 17 by mid-December.

Ladies and gentlemen,
During this meeting, you will take a look at safety and immunogenicity data emerging from Phase 1 clinical trials of two candidate vaccines and review the status of other vaccines.

It is my understanding that no major safety signals have been reported to date. Trials of the Merck vaccine have restarted after a pause at the end of December.

You will look at vaccine pipelines and consider the plans of companies to extend the safety database during Phase 2 evaluation.

Critically important will be your discussion of preparations for Phase 3 efficacy trials in the three countries, using different trial designs that can take our knowledge base some big steps forward.

We will seek clarity on roles and responsibilities and how to coordinate the different actions. We also need some hard thinking about implementation challenges and how to overcome them.

Financing and implementation of vaccination campaigns are covered in session 4.

You will hear from GAVI and others about planned investments and from WHO’s experienced Ebola fighter, Jean-Marie Okwo-Bele.

Okwo will propose some triggers that can guide decisions about when and how to launch vaccination campaigns.

I think all of us have high expectations for the outcome of this meeting.

As a WHO staff member who has spent several months in Guinea recently observed, what people need most is hope.

They have watched families and communities torn apart by this virus for a year and are close to despair.

You can give them some of that hope.
Thank you.

WHO Press Releases
:: No Ebola cases detected in Iraq
6 January 2015 — The Ministry of Health in Iraq, in collaboration with WHO, confirms that there is no suspected case of Ebola virus disease in Iraq as of 5 January 2015.
:: New UNMEER chief arrives in Liberia to assess Ebola response
6 January 2015 — The new Head of UNMEER, Ismail Ould Cheikh Ahmed, arrived in Liberia as part of his first tour of the affected countries.

Johnson & Johnson Announces Start of Phase 1 Clinical Trial of Ebola Vaccine Regimen

Johnson & Johnson Announces Start of Phase 1 Clinical Trial of Ebola Vaccine Regimen
Company Has Produced More Than 400,000 Vaccine Regimens for Use in Large-Scale Clinical Trials by April 2015

NEW BRUNSWICK, N.J. – Jan. 6, 2015 – Johnson & Johnson (NYSE: JNJ) today announced the start of a Phase 1, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January.

Johnson & Johnson also announced today that Janssen, in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of 2 million regimens will be available through the course of 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period. This increased projection is an update to Janssen’s previous goal of producing more than 1 million regimens by the end of 2015, with 250,000 regimens for broad application in clinical trials by May 2015.

“As a leader in the field of global health, we have a responsibility to act swiftly as Ebola continues to cause suffering among patients, families and health care workers in West Africa,” said Alex Gorsky, Chairman and CEO of Johnson & Johnson.

Modelling by the London School of Hygiene and Tropical Medicine to advise the World Health Organization (WHO) indicates that to bring the epidemic under control, current projected demand for a preventive vaccine ranges from a minimum of 100,000 doses to protect frontline workers to a high-end of 12 million doses for large-scale adult vaccination in the three affected countries.

…The Phase 1, first-in-human study will evaluate the safety and tolerability of a prime-boost vaccine regimen, in which patients are first given a dose to prime the immune system, and then a boost intended to enhance the immune response over time. The immune response generated by the regimen will also be evaluated longer term. Different regimens combining the vaccine components or placebo will be studied in 72 healthy adult volunteers. Additional clinical studies are planned to begin in the United States later this month and soon after in Africa. Further details of the study are posted on clinicaltrials.gov.

In October 2014, Johnson & Johnson announced a commitment of up to $200 million to accelerate and significantly expand production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company is seeking to share the financial risk of these vaccine and development clinical trial costs by pursuing governmental and non-governmental funding sources. The vaccine regimen, which was discovered in a collaborative research program with the National Institutes of Health (NIH), uses a prime-boost combination of two components that are based on AdVac® technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic, a biotechnology company based in Denmark.

The Crucell Holland B.V. program received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I, respectively. Preclinical experiments of the prime-boost vaccine regimen conducted by the NIH demonstrated that when both vaccines were administered two months apart, complete protection from death due to Ebola was achieved against the Kikwit Zaire strain, which is similar to the virus that is the cause of the current outbreak in West Africa. The research collaboration for a monovalent vaccine targeting the Zaire strain of the Ebola virus is part of an ongoing development program for a multivalent vaccine against all virus strains that cause disease in humans, including Ebola and Marburg viruses based on the Ad26 and Ad35 vectors.

The Johnson & Johnson Family of Companies continues to closely collaborate with WHO, NIAID and the European Commission, as well as other key stakeholders, governments, public health authorities, and non-governmental organizations on the clinical testing, development, production and distribution of the vaccine…

clinicaltrials.gov :: A Safety and Immunogenicity Study of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

Merck-NewLink Ebola vaccine trial resumes at lower dose -Geneva hospital – Reuters | 5 January 2015

Merck-NewLink Ebola vaccine trial resumes at lower dose -Geneva hospital
Reuters | 5 January 2015
Excerpt
The clinical trial of an Ebola vaccine developed by Merck and NewLink resumed on Monday at a lower dose after a pause to assess complaints of joint pains in some volunteers, the University of Geneva hospital said…
…The Geneva hospital announced on Dec. 11 that its vaccine trial had been suspended as a precautionary measure after four patients complained of joint pains. On Monday, the hospital said 10 of 59 volunteers who received the vaccine had felt pains in their joints “similar to rheumatism” after some two weeks, but these symptoms had disappeared rapidly without any treatment.
Swissmedic, the Swiss regulatory agency, and ethics and safety committees have approved the resumption of the trial at a lower dose, the hospital said in a statement.
“The second part of this clinical trial will now test a dose of 300,000 vaccine particles, which should be better tolerated by volunteers and will hopefully trigger the production of enough antibodies,” it said, noting that the initial phase had 10 million to 50 million vaccine particles.
“Fortunately”, it said, the Merck-NewLink candidate vaccine “seems able to induce the production of antibodies at lower doses than those previously used” in the Geneva trial.
Vaccinations have now resumed for the last 56 volunteers, who will receive either a low dose of the vaccine or a placebo, by groups of 15 each week through January, it said…

UNICEF Watch [to 10 January 2015]

UNICEF Watch [to 10 January 2015]

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:: UNICEF helps restart measles immunizations in Ebola-hit countries
ENEVA/DAKAR/CONAKRY/FREETOWN/MONROVIA, 9 January 2015 – UNICEF is helping governments and communities restart stalled immunizations amid a surge in measles cases in Ebola-affected countries, where health systems are overwhelmed and tens of thousands of children are left vulnerable to deadly diseases.

“Measles is a major killer of children that can easily be stopped through a safe and effective vaccine,” said Manuel Fontaine, UNICEF Regional Director for West and Central Africa. “But immunization rates have dropped significantly, further threatening children’s lives.”

In Guinea, where a measles outbreak was declared in early 2014 – prior to Ebola – the number of confirmed measles cases increased almost fourfold, from 59 between January and December 2013 to 215 for the same period in 2014, according to WHO. In Sierra Leone, the figure tripled from 13 to 39 over the same period.

In Liberia, which had reported no measles in 2013, four cases have been confirmed in Lofa County, one of the areas hardest hit by Ebola.
The increase in cases of measles – a highly contagious disease – is of particular concern as a drop in immunization coverage rates has left children vulnerable at a time when measles transmission traditionally peaks in West Africa, between December and March…

…As vaccinators venture out to provide lifesaving vaccines, which in many cases are long overdue, they also help with the control of the Ebola outbreak. In compliance with infection prevention and control (IPC) procedures and WHO guidelines on immunization in the context of an Ebola outbreak, UNICEF is providing not only vaccines, but also kits that include gloves and infrared thermometers for vaccinators. Vaccinators are being trained on infection prevention and control measures, supervision during immunization activities, and on how to conduct outreach sessions in areas which have not reported an Ebola case for 42 days…

CDC/MMWR Watch [to 10 January 2015]

CDC/MMWR Watch [to 10 January 2015]
http://www.cdc.gov/media/index.html

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:: Enhanced Airport Entry Screening To End for Travelers from Mali to the United States – Press Release – Monday, January 5, 2015

:: MMWR Weekly, January 9, 2015 / Vol. 63 / No. 53
– Notes from the Field: Acute Flaccid Myelitis Among Persons Aged ≤21 Years — United States, August 1–November 13, 2014
– Notes from the Field: Occupationally Acquired HIV Infection Among Health Care Workers — United States, 1985–2013

MSF/Médecins Sans Frontières [to 10 January 2015]

MSF/Médecins Sans Frontières [to 10 January 2015]

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:: Oxford University Begins Trial of Possible Ebola Treatment at MSF Treatment Center in Monrovia
January 07, 2015
A clinical trial of a possible treatment for Ebola began on January 1, 2015, at ELWA 3, the Doctors Without Borders/Médecins Sans Frontières (MSF) Ebola Management Center in Monrovia, Liberia. Led by Oxford University, the trial aims to determine if the antiviral drug brincidofovir is a safe and effective treatment for Ebola. While MSF hopes that brincidofovir might help patients survive infection, it is still not sure whether this will be the case.

WHO & Regionals [to 10 January 2015]

WHO & Regionals [to 10 January 2015]
:: 136th WHO Executive Board session
26 January–3 February 2015

:: WHO grants approval for safe, effective meningitis A vaccine for infants
9 January 2015
WHO has opened the door to routine immunization of infants in Africa by approving for use an innovative and affordable vaccine that has all but rid the meningitis belt of a major cause of deadly epidemics.
Since its introduction in Africa in December 2010, MenAfriVac has had an immediate and dramatic impact in breaking the cycle of meningitis A epidemics, leading the safe, effective technology to be approved by WHO through its prequalification process for use in infants, and paving the way for protecting millions more children at risk of the deadly disease.
Read the news release on meningitis A vaccine

:: Global Alert and Response (GAR): Disease Outbreak News (DONs)
– Ebola virus disease – United Kingdom 30 December 2014
On 29 December 2014, WHO was notified by the National IHR Focal Point for the United Kingdom of a laboratory-confirmed case of Ebola Virus Disease (EVD). This is the first EVD case to be detected on UK soil.
– 5 January 2015 – Middle East respiratory syndrome coronavirus (MERS-CoV) – Jordan
On 25 December 2014, the National IHR Focal Point of Jordan notified WHO of 1 additional case of Middle East respiratory syndrome coronavirus (MERS-CoV) infection.
Contact tracing of household contacts and healthcare contacts is ongoing for this case.
The National IHR Focal Point for the Kingdom of Saudi Arabia also notified WHO of the death of 3 previously reported MERS-CoV cases.*
Globally, the WHO has been notified of 945 laboratory-confirmed cases of infection with MERS-CoV, including at least 348 related deaths.

:: The Weekly Epidemiological Record (WER) for 9 January 2015, vol. 90, 1/2 (pp. 1–8) includes:
– Immunization and Vaccine related Implementation Research Advisory Committee (IVIR-AC): summary of conclusions and recommendations 17–19 September 2014 meeting

WHO Regional Offices
WHO African Region AFRO
Press Releases
:: Sexual and intimate partner violence affects millions in Africa
Brazzaville, 5 January 2015 – In the African Region, one in five girls have been sexually abused during childhood, with estimates from some countries placing that proportion closer to one in three. This startling statistic is highlighted in the newly released Global status report on violence prevention 2014.

WHO Region of the Americas PAHO
:: PANAFTOSA marks three years without foot-and-mouth disease outbreaks in the Americas
Rio de Janeiro, 5 January 2015 (PANAFTOSA) – January 2015 marks the third year in a row in which the Region of the Americas has had no outbreak of foot-and-mouth disease (FMD), a highly contagious animal disease that can have a devastating impact on livestock.
In marking the achievement, the Pan American Foot-and-Mouth Disease Center (PANAFTOSA), a specialized technical center of the Pan American Health Organization (PAHO), noted the importance of the investments and hard work of the two organizations’ member countries.
Foot-and-mouth disease (FMD) is a highly contagious viral disease that primarily affects cloven-hooved livestock and wildlife. Outbreaks can severely disrupt livestock production and trade, causing major economic losses and threatening food security. FMD is not related to hand, foot and mouth disease, a condition seen only in humans, and is not considered a public health problem, as human cases are extremely rare…

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
:: United Kingdom Ebola case: tracing of airline passengers completed 10-01-2015
:: Kyrgyz initiatives help reduce preventable child mortality 08-01-2015

WHO Eastern Mediterranean Region EMRO
No new digest content identified.

WHO Western Pacific Region
No new digest content identified.

BMGF – Gates Foundation Watch [to 10 January 2015]

BMGF – Gates Foundation Watch [to 10 January 2015]
http://www.gatesfoundation.org/Media-Center/Press-Releases

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New Collection by More Than 30 World-Renowned Artists Illustrates the Global Impact of Vaccines
The Art of Saving a Life Project Features the Work of Angélique Kidjo, Chimamanda Ngozi Adichie, GMB Akash, Sophie Blackall, Thomas Ganter, Vik Muniz, Alexia Sinclair and Others, and Debuts at Critical Moment for Global Vaccine Advocacy

SEATTLE (January 7, 2015) — The Bill & Melinda Gates Foundation today introduced The Art of Saving a Life project, a new initiative that brings together more than 30 world-renowned musicians, writers, filmmakers, painters, sculptors and photographers to demonstrate how vaccines continue to positively change the course of history.

The Art of Saving a Life is designed to support the critical work of Gavi, the Vaccine Alliance by spurring conversations about the value of vaccines. On January 27 in Berlin, German Chancellor Angela Merkel will host a high-level event seeking to mobilize funding for Gavi to help reach an additional 300 million children with life-saving vaccines by 2020. The conference will bring together world leaders, nongovernmental organizations, the private sector and other partners who will show their support for Gavi, and will feature select pieces of The Art of Saving a Life artwork.

“From sculptures to paintings, from digital animations to music, artists have been inspired to capture the amazing power of vaccines,” said Gavi CEO Dr. Seth Berkley. “I’m looking forward to seeing a large part of this work in Berlin, where we will be calling on global leaders to stand together and pledge the necessary funds to immunize 300 million children by 2020, which will prevent up to 6 million deaths. This is a remarkable mix of both the art and science of saving a life.”…

IVI Watch [to 10 January 2015]

IVI Watch [to 10 January 2015]
http://www.ivi.org/web/www/home

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SK Chemicals staff’s interview with SBS TV about collaboration with IVI and BMGF
[Undated]
An interview featuring Dr. KIM Hoon, head of SK Chemicals’ life-science lab, was on SBS ? CNBC TV, a Korean cable station dedicated to business and market, including comments about collaboration with IVI and BMGF. Here are some highlights from the interview.

Q. We hear that SK Chemicals is jointly developing a typhoid fever vaccine.
A. Yes. That’s right.

Q. Notably, SK Chemicals received funding from the Bill & Melinda Gates Foundation, right?
A. SK Chemicals is committed to its mission of improving the health of human beings. The joint development of typhoid vaccine with IVI is very significant in our efforts to achieve this mission.
The fact that IVI picked SK as a partner, and that the Gates provided 5.4 billion won fund is testament to that SK’s vaccine development and production capacities has reached the global level.
By developing a more improved vaccine, SK Chemicals will contribute to saving the precious lives of children in developing countries.
Phase 1 clinical trials will start late this year, and after completion of clinical trials, the vaccine will be produced at SK Chemicals’ plant in Andong, and will be supplied through international organizations.

Q: Could support from the Gates Foundation and cooperation with IVI mean that securing financial profitability is a challenge?
A. It is not a matter of profitability. The shared goal of the two organizations is to improve the health of humanity through vaccines. SK Chemicals also shares this goal.

Q: We hear that prequalification (PQ) is key to this endeavor. Would it be possible to achieve?
A. The new vaccine will likely provide long-term protection, and protection in young children under age 2, which conventional typhoid vaccines do not.
To save children’s lives in developing countries, entering the global market is essential. Due support from IVI, and the Food and Drug Safety Ministry of Korea, and to SK Chemicals’ world-class capacity, we expect development will be completed in line with schedule.

To hear the full interview please click here:
http://sbscnbc.sbs.co.kr/read.jsp?pmArticleId=10000712198

Industry Watch [to 10 January 2015]

Industry Watch [to 10 January 2015]

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:: Pfizer Acquires Redvax GmbH
Acquisition Provides Pfizer with a Preclinical CMV Vaccine Candidate
January 05, 2015
NEW YORK–( Pfizer Inc. today announced that it has acquired a controlling interest in Redvax GmbH, a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, based in Zurich-Schlieren. This transaction provides access to a preclinical human cytomegalovirus (CMV) vaccine candidate, as well as intellectual property and a technology platform related to a second, undisclosed vaccine program…

Global Fund [to 10 January 2015]

Global Fund [to 10 January 2015]
http://www.theglobalfund.org/en/mediacenter/

Press releases
Zambia and Global Fund Sign $234 Million in New Grants
09 January 2015
LUSAKA, Zambia – The Government of the Republic of Zambia, the Churches Health Association of Zambia, and the Global Fund today reaffirmed their partnership, signing four new grants worth US$234 million to fight HIV, TB and malaria in Zambia.

The financial resources provided through the Global Fund come from many donors, represented today by the European Union, Sweden, the United Kingdom and the United States. Beyond finances, the grant agreements embody solidarity with the people of Zambia, supporting health initiatives through partnership with UNAIDS, UNICEF, UNDP, UNFPA, WFP and WHO, (RED), ONE and the Bill & Melinda Gates Foundation and others.

The HIV/TB grants expand availability of anti-retroviral medication for people living with both HIV and tuberculosis from 80 percent in 2013 to a target of 90 percent by 2017. Zambia will also intensify TB case detection among key populations, children, prisoners and other groups identified by Zambia’s TB survey, and enhance HIV/TB integration.
The malaria grants aim to sustain universal coverage of treatment and increase household use of mosquito nets from 49 percent in 2012 to 85 percent by 2017. The number of malaria cases and deaths is expected to halve in 2017 compared with 2013. The grants also strengthen community and health systems…

American Journal of Tropical Medicine and Hygiene – January 2015; 92 (1)

American Journal of Tropical Medicine and Hygiene
January 2015; 92 (1)
http://www.ajtmh.org/content/current

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Editorial
Expanding the Toolbox in Pursuit of a Strain Transcendent Malaria Vaccine
Anne E.P. Frosch and Chandy C. John
Am J Trop Med Hyg 2015 92:1-2; Published online November 24, 2014, doi:10.4269/ajtmh.14-0662
[No abstract]

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Environmental Surveillance for Toxigenic Vibrio cholerae in Surface Waters of Haiti
Am J Trop Med Hyg 2015 92:118-125; Published online November 10, 2014, doi:10.4269/ajtmh.13-0601
Amy M. Kahler, Bradd J. Haley, Arlene Chen, Bonnie J. Mull, Cheryl L. Tarr, Maryann Turnsek, Lee S. Katz, Michael S. Humphrys, Gordana Derado, Nicole Freeman, Jacques Boncy, Rita R. Colwell, Anwar Huq, and Vincent R. Hill
Abstract
Epidemic cholera was reported in Haiti in 2010, with no information available on the occurrence or geographic distribution of toxigenic Vibrio cholerae in Haitian waters. In a series of field visits conducted in Haiti between 2011 and 2013, water and plankton samples were collected at 19 sites. Vibrio cholerae was detected using culture, polymerase chain reaction, and direct viable count methods (DFA-DVC). Cholera toxin genes were detected by polymerase chain reaction in broth enrichments of samples collected in all visits except March 2012. Toxigenic V. cholerae was isolated from river water in 2011 and 2013. Whole genome sequencing revealed that these isolates were a match to the outbreak strain. The DFA-DVC tests were positive for V. cholerae O1 in plankton samples collected from multiple sites. Results of this survey show that toxigenic V. cholerae could be recovered from surface waters in Haiti more than 2 years after the onset of the epidemic.

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The Development and Implementation of a Competency-Based Curriculum for Training in Global Health Research
Thanh G. N. Ton, Sophia P. Gladding, Joseph R. Zunt, Chandy John, Vivek R. Nerurkar, Cheryl A. Moyer, Nicole Hobbs, Molly McCoy and Joseph C. Kolars*
Author Affiliations
Departments of Neurology and Global Health, University of Washington, Seattle, Washington; Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota; Department of Medicine (Infectious Disease), University of Washington, Seattle, Washington; Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii; Global Research, Education and Collaboration in Health (REACH) and Departments of Learning Health Sciences and Internal Medicine, University of Michigan, Ann Arbor, Michigan
Abstract
The Fogarty International Center (FIC) Global Health Fellows Program provides trainees with the opportunity to develop research skills through a mentored research experience, increase their content expertise, and better understand trends in global health research, funding organizations, and pathways to generate support. The Northern Pacific Global Health Fellows Research and Training Consortium, which hosts one of the FIC Global Health Programs, sought to enhance research training by developing, implementing, and evaluating a competency-based curriculum that uses a modular, asynchronous, web-based format. The curriculum has 8 core competencies, 36 learning objectives, and 58 assignments. Nineteen trainees completed their 11-month fellowship, engaged in the curriculum, and provided pre- and post-fellowship self-assessments. Self-assessed scores significantly improved for all competencies. Trainees identified the curriculum as one of the strengths of the program. This competency-based curriculum represents a first step toward creating a framework of global health research competencies on which further efforts could be based.

Annals of Internal Medicine – 6 January 2015, Vol. 162. No. 1

Annals of Internal Medicine
6 January 2015, Vol. 162. No. 1
http://annals.org/issue.aspx

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Original Research | 6 January 2015
Effect of Ebola Progression on Transmission and Control in Liberia
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Dan Yamin, PhD*; Shai Gertler*; Martial L. Ndeffo-Mbah, PhD*; Laura A. Skrip, MPH; Mosoka Fallah, PhD; Tolbert G. Nyenswah, MPH; Frederick L. Altice, MD, MA; and Alison P. Galvani, PhD
[+] Article and Author Information
Ann Intern Med. 2015;162(1):11-17. doi:10.7326/M14-2255
* Dr. Yamin, Mr. Gertler, and Dr. Ndeffo-Mbah contributed equally to this work.
Abstract
Background: The Ebola outbreak that is sweeping across West Africa is the largest, most volatile, and deadliest Ebola epidemic ever recorded. Liberia is the most profoundly affected country, with more than 3500 infections and 2000 deaths recorded in the past 3 months.
Objective: To evaluate the contribution of disease progression and case fatality on transmission and to examine the potential for targeted interventions to eliminate the disease.
Design: Stochastic transmission model that integrates epidemiologic and clinical data on incidence and case fatality, daily viral load among survivors and nonsurvivors evaluated on the basis of the 2000–2001 outbreak in Uganda, and primary data on contacts of patients with Ebola in Liberia.
Setting: Montserrado County, Liberia, July to September 2014.
Measurements: Ebola incidence and case-fatality records from 2014 Liberian Ministry of Health and Social Welfare.
Results: The average number of secondary infections generated throughout the entire infectious period of a single infected case, R, was estimated as 1.73 (95% CI, 1.66 to 1.83). There was substantial stratification between survivors (RSurvivors), for whom the estimate was 0.66 (CI, 0.10 to 1.69), and nonsurvivors (RNonsurvivors), for whom the estimate was 2.36 (CI, 1.72 to 2.80). The nonsurvivors had the highest risk for transmitting the virus later in the course of disease progression. Consequently, the isolation of 75% of infected individuals in critical condition within 4 days from symptom onset has a high chance of eliminating the disease.
Limitation: Projections are based on the initial dynamics of the epidemic, which may change as the outbreak and interventions evolve.
Conclusion: These results underscore the importance of isolating the most severely ill patients with Ebola within the first few days of their symptomatic phase.
Primary Funding Source: National Institutes of Health.

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The Potential Ebola–Infected Patient in the Ambulatory Care Setting: Preparing for the Worst Without Compromising Care
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Henry M. Wu, MD; Jessica K. Fairley, MD; James Steinberg, MD; and Phyllis Kozarsky, MD

Caring for Patients With Ebola: A Challenge in Any Care Facility
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Mark G. Kortepeter, MD, MPH; Philip W. Smith, MD; Angela Hewlett, MD; and Theodore J. Cieslak, MD

British Medical Journal – 10 January 2015 (vol 350, issue 7990)

British Medical Journal
10 January 2015 (vol 350, issue 7990)
http://www.bmj.com/content/350/7990

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Editorials
Two or three doses of human papillomavirus vaccine?
Julia Brotherton, medical director
Author affiliations
BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.g7778 (Published 07 January 2015) Cite this as: BMJ 2015;350:g7778
Switching to two doses looks feasible, but only with careful monitoring
Human papillomavirus (HPV) vaccines have the potential to prevent the considerable morbidity and mortality caused by oncogenic HPV types. In the eight years since the vaccines were first licensed, we have seen remarkable reductions in genital warts, HPV infections, and pre-cancerous cervical lesions in vaccinated populations.1 2 3 4 5 6 7 8 However, achieving high coverage with three doses of vaccine is challenging in many populations, and the cost of the vaccine has kept it out of reach for many countries. In a linked paper (doi:10.1136/bmj.g7584), Jit and colleagues explore, through modelling, the potential cost effectiveness of a two dose HPV vaccination schedule.9
Both the bivalent and quadrivalent HPV vaccines were initially registered for use as three dose courses given over six months, using the model of subunit vaccines for which multiple doses are needed to generate a sufficient immune response. However, HPV vaccines are notably immunogenic, producing very high and durable antibody responses, and the virus-like particle structure of the vaccines, with their repetitive antigen display, may be stimulating immunity that is more akin to the response generated by viral infections or live vaccines.10 …

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Research
Comparison of two dose and three dose human papillomavirus vaccine schedules: cost effectiveness analysis based on transmission model
Mark Jit, mathematical modeller and health economist12, Marc Brisson, associate professor of mathematical epidemiology and health economics345, Jean-François Laprise, mathematical modeller3, Yoon Hong Choi, mathematical modeller16
Author affiliations
BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.g7584 (Published 07 January 2015) Cite this as: BMJ 2015;350:g7584
Abstract
Objective
To investigate the incremental cost effectiveness of two dose human papillomavirus vaccination and of additionally giving a third dose.
Design
Cost effectiveness study based on a transmission dynamic model of human papillomavirus vaccination. Two dose schedules for bivalent or quadrivalent human papillomavirus vaccines were assumed to provide 10, 20, or 30 years’ vaccine type protection and cross protection or lifelong vaccine type protection without cross protection. Three dose schedules were assumed to give lifelong vaccine type and cross protection.
Setting
United Kingdom.
Population
Males and females aged 12-74 years.
Interventions
No, two, or three doses of human papillomavirus vaccine given routinely to 12 year old girls, with an initial catch-up campaign to 18 years.
Main outcome measure
Costs (from the healthcare provider’s perspective), health related utilities, and incremental cost effectiveness ratios.
Results
Giving at least two doses of vaccine seems to be highly cost effective across the entire range of scenarios considered at the quadrivalent vaccine list price of £86.50 (€109.23; $136.00) per dose. If two doses give only 10 years’ protection but adding a third dose extends this to lifetime protection, then the third dose also seems to be cost effective at £86.50 per dose (median incremental cost effectiveness ratio £17 000, interquartile range £11 700-£25 800). If two doses protect for more than 20 years, then the third dose will have to be priced substantially lower (median threshold price £31, interquartile range £28-£35) to be cost effective. Results are similar for a bivalent vaccine priced at £80.50 per dose and when the same scenarios are explored by parameterising a Canadian model (HPV-ADVISE) with economic data from the United Kingdom.
Conclusions
Two dose human papillomavirus vaccine schedules are likely to be the most cost effective option provided protection lasts for at least 20 years. As the precise duration of two dose schedules may not be known for decades, cohorts given two doses should be closely monitored

Contemporary Clinical Trials – Volume 41, In Progress (March 2015)

Contemporary Clinical Trials
Volume 41, In Progress (March 2015)

Immunogenicity and safety of measles–mumps–rubella vaccine delivered by disposable-syringe jet injector in healthy Brazilian infants: A randomized non-inferiority study
Original Research Article
Pages 1-8
Reinaldo de Menezes Martins, Birute Curran, Maria de Lourdes Sousa Maia, Maria das Graças Tavares Ribeiro, Luiz Antonio Bastos Camacho, Marcos da Silva Freire, Anna Maya Yoshida Yamamura, Marilda Mendonça Siqueira, Maria Cristina F. Lemos, Elizabeth Maciel de Albuquerque, Vanessa dos Reis von Doellinger, Akira Homma, Laura Saganic, Courtney Jarrahian, Michael Royals, Darin Zehrung
Abstract
This study aimed to determine if immunogenicity to measles–mumps–rubella vaccine delivered to infants via a disposable-syringe jet injector (DSJI) was non-inferior to that administered by needle and syringe (NS). Vaccination safety was evaluated, as were the use, performance, and acceptability of each delivery method. The DSJI was the PharmaJet® 2009 generation-1 device (G1) and the vaccine was measles–mumps–rubella vaccine from Bio-Manguinhos. Five hundred eighty-two healthy Brazilian infants were randomized to receive vaccine via G1 or NS. Seroconversion rates against measles and mumps viruses in the G1 treatment group did not meet non-inferiority criteria when compared with the NS group; however, responses in the G1 group to rubella virus were non-inferior to those of NS vaccinees. Most adverse events were mild or moderate. Crying after injection was more frequent in the NS group, and local skin reactions were more common in the G1 group. Five serious adverse events were judged causally unrelated to treatment and all resolved. Parents/guardians expressed a strong preference for G1 over NS for their children. Vaccinators found the G1 easy to use but noted incomplete vaccine delivery in some cases. Although the G1 has been superseded by an updated device, our results are important for the continued improvement and evaluation of DSJIs, which have the potential to overcome many of the challenges and risks associated with needle-based injections worldwide. Recommendations for future DSJI clinical studies include rigorous training of vaccinators, quantitative measurement of wetness on the skin following injection, and regular monitoring of device and vaccinator performance.