Vaccines and Global Health: The Week in Review 25 October 2014

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_25 October 2014

- blog edition: comprised of the 35+ entries posted below on 28 September 2014

- 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

Editor’s Note:
The gravity and complexity of the Ebola/EVD crisis continue to accelerate. We will strive to present a coherent, high-level digest of thre situation using official sources wherever possible, with a special focus on vaccines and other preventive strategies. Reading this issue you will encounter significant Ebola/EVD content throughout.

 

POLIO [to 25 October 2014]

POLIO [to 25 October 2014]

GPEI Update: Polio this week – As of 22 October 2014
Global Polio Eradication Initiative
Editor’s Excerpt and text bolding
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: World Polio Week, starting on 23 October, provides an opportunity to recognize the progress made towards the global eradication of polio in 2014. This year is the first year with South East Asia certified as polio-free.
:: The Canadian Prime Minister Stephen Harper was awarded Rotary International’s Polio Eradication Champion Award on 18 October in recognition of his efforts to achieve a polio free world. Canada has been a long standing supporter of the Global Polio Eradication Initiative since 1988.
:: Pakistan has reached 210 cases of paralysis caused by wild poliovirus in 2014. This is the highest number of cases on record by October in any year, and accounts for more than 85% of all cases worldwide.
Pakistan
:: Four new wild poliovirus type 1 (WPV1) cases were reported in the past week in Pakistan. Of these, 3 are from the Federally Administered Tribal Areas (FATA) (1 from South Waziristan and 2 from Khyber Agency); and 1 from Lakki Marwat district of Khyber Pakhtunkhwa (KP) province. The most recent case had onset of paralysis on 1 October. This brings the total number of WPV1 cases in 2014 to 210 compared to 46 in 2013 by this date.
:: Immunization activities are continuing with particular focus on known high-risk areas, in particular the newly opened areas of FATA. At exit and entry points of areas that are inaccessible during polio campaigns, 163 permanent vaccination points are being used to reach internally displaced families as they move in and out of the inaccessible area.

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World Polio Day 2104
:: Ten million childhood disabilities prevented in campaign to end polio – UNICEF
NEW YORK, 23 October 2014 – Every day, a thousand or so children have been protected from disability during a 26-year global effort to eradicate polio. The worldwide campaign has immunised millions of previously-unreached children across the globe, UNICEF said on the eve of World Polio Day…

:: MMWR October 24, 2014 / Vol. 63 / No. 42
- World Polio Day — October 24, 2014
- Polio-Free Certification and Lessons Learned — South-East Asia Region, March 2014

:: Rotary marks World Polio Day 2014 with US$44.7 million in grants to fight polio in Africa, Asia and the Middle East
Oct 21, 2014, With the world “This Close”—99%—to eliminating polio from the planet, the effort is receiving an additional US$44.7 million boost from Rotary to support immunization activities, surveillance, and research spearheaded by the Global Polio Eradication Initiative.

:: IVAC – Celebrating Progress on World Polio Day

The long-term cure for Ebola: An investment in health systems – Ellen Johnson-Sirleaf

Washington Post
19 October 2014
Opinion
The long-term cure for Ebola: An investment in health systems
by Ellen Johnson-Sirleaf, President of Liberia.

As the Ebola nightmare continues in Liberia and as we battle to contain the epidemic, it is important to look beyond the immediate crisis. Many more lives will be lost before this dreadful outbreak is beaten, but to properly honor the memory of the victims we need to ask how it happened in the first place and, more pressingly, how we can prevent it from happening again.

After 30 years of brutal civil and political unrest, Liberia was a nation reborn. We transformed our country from a failed state into a stable democracy, rebuilding its infrastructure and its education and health systems, and enjoying one of the most promising growth records in Africa. Then Ebola swept in, threatening to tear apart that progress. It is a terrifying reminder of the destructive power of infectious disease, one all the more devastating given how far Liberia has come.

Without a doubt, part of the reason for this situation is that, with the exception of Doctors Without Borders, the initial international response to this emergency was markedly slow. This gave Ebola the time it needed to overwhelm our already-fragile health infrastructure.

President Obama has since committed to sending up to 4,000 military personnel to West Africa to set up much-needed health-care facilities and to train health-care workers, and last week he authorized the use of additional reserves, if needed. This will help our efforts to contain the outbreak, and we are truly thankful.
Similarly, a suitable vaccine and treatment for Ebola could have helped prevent this outbreak from getting out of control. And, indeed, efforts to fast-track the development of a promising candidate vaccine could potentially help to bring this all to a swifter end, even if initially there were only enough doses to vaccinate health workers on the front line.

But while these are very much welcome developments, they are nevertheless responses to an outbreak already out of control. After all, military field hospitals would not be needed if adequate health-care services were in place. And, as Uganda has demonstrated after several terrible outbreaks, the key to preventing a major outbreak is a health infrastructure robust enough to be able to respond quickly and effectively when cases first appear.

Medical staff in Uganda now have the training and means to recognize symptoms and isolate patients immediately, and they have access to appropriate equipment and protective clothing. Similarly, social mobilization networks are in place to get information out to the people to reduce the risk of spread, while laboratory facilities can confirm cases swiftly. It is a highly effective setup that was created with considerable help from the U.S. Centers for Disease Control and Prevention, but it relies wholly upon having strong health infrastructure.

In Liberia, a country that never before had an incidence of Ebola, we were utterly ill-equipped and unprepared. What is so tragic is that, until this outbreak, Liberia had made significant progress in building up its public health systems. With help from organizations such as Gavi, the Vaccine Alliance, we have reduced childhood mortality by two-thirds since 1990, thanks largely to expansive immunization programs.

Much of that good work has now been undermined. Having worked its way through the cracks in our fragile health infrastructure, Ebola has effectively brought health care to a halt in Liberia, as people avoid seeking medical attention. There is nowhere to go. So, with the malaria season setting in and routine immunization programs stopped, even when this outbreak is over we must prepare for other diseases to take hold.

Yet, with Ebola having claimed the lives of 96 of our health workers and infected more than 209 others, recovering is going to be hard. This is a huge hit for a country that had barely 50 doctors to care for a population of 4.4 million at the start of this outbreak.

More than ever, we will be reliant upon assistance from partners such as the United States and Britain, and global health organizations such as the World Health Organization, UNICEF and Gavi, to help rebuild our health systems, invest in health facilities, staff and equipment and restore immunization levels. And it’s not just Liberia — any African nation with a fragile health system is potentially vulnerable to this terrible disease. After all, infectious disease knows no borders.

The United Nations has said it is going to take $1 billion to stop this outbreak. Of course, that’s our immediate priority. But at the same time, countries like Liberia need long-term investment to build up our health systems to prevent outbreaks of this scale from ever happening again. We owe it to the thousands of citizens and health workers who have so far lost their lives to be prepared.

WHO: Statement on the 3rd meeting of the IHR Emergency Committee regarding the 2014 Ebola outbreak in West Africa

WHO: Statement on the 3rd meeting of the IHR Emergency Committee regarding the 2014 Ebola outbreak in West Africa
WHO statement
23 October 2014
[Full text; Editor’s text bolding]

The third meeting of the Emergency Committee convened by the WHO Director-General under the IHR 2005 regarding the 2014 Ebola virus disease (EVD, or “Ebola”) outbreak in West Africa was conducted with members and advisors of the Emergency Committee on Wednesday, 22 October 2014, from 13:00 to 17:10 CET.

This meeting was convened in advance of the 3-month date of the expiration of the temporary recommendations issued on 8 August 2014 and their extension on 22 September 2014, owing to the increase in numbers of cases in Guinea, Liberia, and Sierra Leone, and the new exportation of cases resulting in limited transmission in Spain and United States of America.

Current situation
The current situation was reviewed. As of 22 October 2014, the number of total cases stands at 9936 total cases, with 4877 deaths. Cases continue to increase exponentially in Guinea, Liberia, and Sierra Leone; the situation in these countries remains of great concern. The key lessons learned to control the outbreak include the importance of leadership, community engagement, bringing in more partners, paying staff on time, and accountability. WHO, UN partners and the international community have scaled up their support in these three countries.

The outbreaks in Nigeria and Senegal were declared over as of 20 October and 17 October, respectively. The Committee welcomed this development and commended those involved in this achievement.

Cases have recently occurred in Spain and United States of America. The index cases in both of these countries originated in West Africa.

Update by IHR States Parties
After the overview summary, the following IHR States Parties provided an update on and assessment of the Ebola situation in their countries, including progress towards implementation of the Emergency Committee’s Temporary Recommendations: Guinea, Liberia, Sierra Leone, Spain, and United States of America.

It was the unanimous view of the Committee that the event continues to constitute a Public Health Emergency of International Concern (PHEIC).

In light of States Parties’ presentations and subsequent Committee discussions, several points and challenges were noted for the affected countries and other countries. The primary emphasis must continue to be stopping the transmission of Ebola within the 3 affected countries with intense transmission. This action is the most important step for preventing international spread. Specific attention, including through appropriate monitoring and follow-up of their health, should be paid to the needs of health care workers.

This will also encourage more health care staff to assist in this outbreak.

The Committee reviewed the recommendations issued on 8 August and the comments published on 22 September, and provided the following additional advice to the Director-General for her consideration in addressing the Ebola outbreak in accordance with IHR (2005). All previous temporary recommendations remain in effect. Even though a few cases have occurred outside the 3 countries with intense transmission, the measures recommended appear to have been helpful in limiting further international spread. Additional recommendations follow below.

Recommendations for States with intense Ebola transmission (Guinea, Liberia, Sierra Leone)
Exit screening in Guinea, Liberia and Sierra Leone remains critical for reducing the exportation of Ebola cases. States should maintain and reinforce high-quality exit screening of all persons at international airports, seaport, and major land crossings, for unexplained febrile illness consistent with potential Ebola infection. The exit screening should consist of, at a minimum, a questionnaire, a temperature measurement and, if fever is discovered, an assessment of the risk that the fever is caused by Ebola virus disease (EVD). States should collect data from their exit screening processes, monitor their results, and share these with WHO on a regular basis and in a timely fashion. This will increase public confidence and provide important information to other States.

WHO and partners should provide additional support needed by States to further strengthen exit screening processes in a sustainable way.

Recommendations for all States
The Committee reiterated its recommendation that there should be no general ban on international travel or trade. A general travel ban is likely to cause economic hardship, and could consequently increase the uncontrolled migration of people from affected countries, raising the risk of international spread of Ebola. The Committee emphasized the importance of normalizing air travel and the movement of ships, including the handling of cargo and goods, to and from the affected areas, to reduce the isolation and economic hardship of the affected countries. Any necessary medical treatment should be available ashore for seafarers and passengers.
Previous recommendations regarding the travel of EVD cases and contacts should continue to be implemented.

A number of States have recently introduced entry screening measures. WHO encourages countries implementing such measures to share their experiences and lessons learned. Entry screening may have a limited effect in reducing international spread when added to exit screening, and its advantages and disadvantages should be carefully considered.

If entry screening is implemented, States should take into account the following considerations: it offers an opportunity for individual sensitization, but the resource demands may be significant, even if screening is targeted; and management systems must be in place to care for travellers and suspected cases in compliance with International Health Regulations (IHR) requirements.

A number of States without Ebola transmission have decided to or are considering cancelling international meetings and mass gatherings. Although the Committee does not recommend such cancellations, it recognizes that these are complex decisions that must be decided on a case-by-case basis. The Committee encourages States to use a risk-based approach to make these decisions. WHO has issued advice for countries hosting international meetings or mass gatherings, and will continue to provide guidance and support on this issue. The Committee agreed that there should not be a general ban on participation of competitors or delegations from countries with transmission of Ebola wishing to attend international events and mass gatherings but that the decision of participation must be made on a case by case basis by the hosting country. The temporary recommendations relating to travel should apply; additional health monitoring may be requested.

All countries should strengthen education and communication efforts to combat stigma, disproportionate fear, and inappropriate measures and reactions associated with Ebola. Such efforts may also encourage self-reporting and early presentation for diagnosis and care.

The Committee emphasized the importance of continued support by WHO and other national and international partners towards the effective implementation and monitoring of these recommendations.

Based on this advice and the information considered by the Committee, the Director-General accepted the Committee’s assessment, and declared that the 2014 Ebola outbreak in Guinea, Liberia and Sierra Leone continued to constitute a Public Health Emergency of International Concern. The Director-General endorsed the Committee’s advice and issued them as Temporary Recommendations under IHR (2005). The Director-General thanked the Committee members and advisors for their advice and requested their reassessment of this situation within 3 months or earlier should circumstances require.

WHO convenes industry leaders and key partners to discuss trials and production of Ebola vaccine – 23 October 2014

WHO convenes industry leaders and key partners to discuss trials and production of Ebola vaccine
24 October 2014 — WHO convened a high-level emergency meeting on 23 October to look at the many complex policy issues that surround access to Ebola vaccines. Ways to ensure the fair distribution and financing of these vaccines were discussed, as well as plans for the different phases of clinical trials to be performed concurrently rather than consecutively, partnerships for expediting clinical trials, and proposals for getting all development partners moving in tandem and at the same accelerated pace.
:: Full report: WHO high-level meeting on Ebola vaccines access and financing
23 October 2014 – 14 pages
:: Summary report of a WHO High-level Meeting on ebola vaccines access and financing
Ebola situation assessment – 23 October 2014
[Full text; Editor’s text bolding]
Introduction
A high-level emergency meeting, convened by WHO at the request of several governments and representatives of the pharmaceutical industry, was held on 23 October to look at the many complex policy issues that surround eventual access to experimental Ebola vaccines.

Ways to ensure the fair distribution and financing of these vaccines were discussed in an atmosphere characterized by a high sense of urgency. This sense of urgency was conveyed in many ways – from plans for the different phases of clinical trials to be performed concurrently rather than consecutively, to suggested partnerships for expediting clinical trials, to proposals for getting all development partners moving in tandem and at the same accelerated pace.

More than 90 participants, including some of the world’s leading scientists, came, on short notice, from national and university research institutions, also in Africa, government health agencies, ministries of health and foreign affairs, national security councils, and several offices of Prime Ministers and Presidents. Also represented were national and regional drug regulatory authorities, the MSF (Doctors Without Borders) medical charity, funding agencies and foundations, the GAVI alliance for childhood immunization, and development banks, including the African Development Bank, the European Investment Bank, and the World Bank Group.

Main conclusions reached
Impact of vaccines on further evolution of the epidemic
The meeting concluded that vaccines will have a significant impact on the further evolution of the epidemic in any scenario, from best-case to worst-case.
Financing of vaccine development, clinical trials, and vaccination campaigns
The meeting concluded that funding issues should not be allowed to dictate the vaccine agenda. The funds will be found.

Liability
The meeting concluded that neither affected countries nor industry should be left alone to bear the burden should lawsuits arise following possible adverse reactions to an Ebola vaccine. To respond to this potential problem, a proposal was made to establish a “club” of donors, in collaboration with the World Bank.

The timing and quantity of vaccine supplies
The meeting concluded that the timing and quantity of vaccine doses should not constrain the design of clinical trials. Industry confirmed that enough vaccine doses would be available.

GlaxoSmithKline’s monthly production capacity for purified bulk vaccine was expected to rise from the current figure of 24,000 doses to 230,000 by April 2015, if they can be filled for release. NewLink’s bulk vaccine manufacturing capacity for the Canadian vaccine was noted to vary, according to the dose selected, from 52,000 doses to 5.2 million doses anticipated for the first quarter of 2015.

Design of protocols for phase 2 and phase 3 clinical trials
The meeting concluded that randomized controlled clinical trials were the gold standard in terms of yielding reliable scientific data for the analysis and interpretation of efficacy. A stepped-wedge design could also yield useful and meaningful data during the special circumstances of the current epidemic.

Priority uses of vaccine when supplies are limited.
The meeting concluded that health care workers, including medical staff, laboratory staff, burial teams, and facility cleaners, should have first call on vaccine doses while supplies remain limited. Vaccination of health care workers in the three countries was judged feasible during the first quarter of 2015.

Regulatory requirements
The meeting concluded that the licensure and authorization requirements of regulatory authorities should be streamlined and harmonized, enabling the rapid introduction of vaccines for clinical trials and general distribution, yet with no compromise of scientific standards. In order to deliver the number of doses on the schedules proposed by the manufacturers, regulators must work closely with the manufacturers to find ways to overcome a number of regulatory hurdles.

Urgent measures to improve readiness for clinical trials and vaccines
The meeting concluded that two preparatory measures should be given the most urgent priority: community engagement and social mobilization to prepare populations to understand and accept clinical trials and vaccination campaigns, and the building of basic public health infrastructures, especially given the considerable logistical challenges facing health services in Guinea, Liberia, and Sierra Leone.

Coordination and alignment among multiple partners
The meeting concluded that a mechanism or framework must be urgently established, relying on WHO’s convening and coordination powers, to get all partners working in tandem, according to a single agreed plan and aligned with industry’s “critical paths” analysis.

Determination to finish the job
The meeting concluded that all efforts to develop, test, and approve Ebola vaccines must be followed through to completion at the current accelerated pace, even if dramatic changes in the epidemic’s transmission dynamics meant that vaccines were no longer needed.

WHO – Meeting of the Ethics Working Group on Ebola Interventions [20 – 21 October 2014, Geneva]

Meeting of the Ethics Working Group on Ebola Interventions
20 – 21 October 2014, Geneva, Switzerland
:: Summary of the Meeting pdf, 218kb
Excerpt
A 1 ½ day meeting was held to map out the ethical issues related to the design of trials to evaluate the safety and efficacy of candidate therapeutic agents for use in the current Ebola Virus Disease outbreak in West Africa. Ten members of the Ethics Working group were assisted by methodologists, statisticians, drug regulators, researchers, and ethics committee chairs/administrators to tease out the ethical issues associated with the different designs. The agenda and the LoP is attached/can be found here.
The meeting was informed by work done on this issues in prior Working Group meetings.

The Ethics Working Group reiterated that the focus on therapeutics at the meeting, did not supersede the requirement to focus efforts on bringing the epidemic under control with enhanced attention and resources for public health measures. Nor did it indicate that other forms of clinical, public health, anthropological, sociological or operational research is without merit in the current outbreak. Many of these types of research can be handled with well understood study designs and oversight mechanisms.

Six case studies on the different trial designs for therapeutics were used to illustrate the ethical dimensions related to their implementation in the context of the Ebola epidemic. The case studies allowed the regulators, researchers, ethics committee chairs/administrators and the representatives of pharmaceutical companies to discuss various aspects of the study designs, the advantages and disadvantages of each, and identify the issues that were relevant for consideration in an ethical analysis during their conduct in an outbreak situation in the affected countries. On day two of the meeting, the members of the Ethics working Group – through a deliberative process – reached consensus on some aspects and identified other aspects for further development through e-discussions.

The Final Meeting Report will summarize the areas of consensus reached by the group and outline a set of outstanding questions that require further attention.
:: Agenda pdf, 206kb
:: List of Participants pdf, 392kb