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

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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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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…