Vaccines and Global Health: The Week in Review 24 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.

pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_24 January 2015

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

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
.
Support:  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…

.
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

136th WHO Executive Board starts with special session on Ebola – Live Webcast – 25 January 2015

136th WHO Executive Board starts with special session on Ebola – Live Webcast
23 January 2015 — The 136th session of the WHO Executive Board will run from Monday, 26 January 2015. On Sunday, 25 January, the Board will hold a special session on the Ebola emergency. The special session will review the current state of WHO’s Ebola response and make recommendations for future large-scale and sustained outbreaks and emergencies. It will also discuss preparedness in non-affected countries and regions.
Live webcast: Sunday 25 January 2015 from 10:00 to 13:00 and 15:00 to 18:00 CET
– Special session – English http://www.who.int/mediacentre/executive-board-live/en/

Major milestone for GSK/NIH candidate Ebola vaccine as first doses shipped to Liberia for use in phase III clinical trial

Major milestone for GSK/NIH candidate Ebola vaccine as first doses shipped to Liberia for use in phase III clinical trial
23 January 2015, Issued: London, UK
Healthcare workers among those to be vaccinated in large-scale trial involving up to 30,000 people due to start in the coming weeks
GSK has announced that the first batch of its candidate Ebola vaccine is being shipped to west Africa and is expected to arrive in Liberia later today Friday 23 January. The shipment, containing an initial 300 vials of the candidate vaccine, is the first to arrive in one of the main Ebola affected countries and will be used to start the first large-scale efficacy trial of experimental Ebola vaccines in the coming weeks.

The candidate vaccine is currently being tested in five small phase I clinical trials in the UK, USA, Switzerland and Mali, involving around 200 healthy volunteers in total. Initial data from these trials show that the candidate vaccine has an acceptable safety profile, including in a west African population, and across the different doses evaluated. Based on the safety and immunological data available from these trials, GSK has selected the most appropriate dosage level to advance to the next phases of clinical testing. Results from the first of the phase I studies were published in November 2014 and results from the remaining phase I studies will be published in the coming months.

The selected dose will now be tested in a large phase III clinical trial led by the US National Institutes of Health (NIH) which is expected to involve up to 30,000 people, one third of whom will receive GSK’s candidate Ebola vaccine. It will compare the candidate vaccine to a control vaccine to assess whether the immune response seen in phase I trials actually translates into meaningful protection against Ebola. This trial will begin in Liberia in the coming weeks, subject to regulatory approval, with further shipments of vaccines to follow.

Dr Moncef Slaoui, Chairman of Global Vaccines at GSK, said: “Shipping the vaccine today is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine. The initial phase I data we have seen are encouraging and give us confidence to progress to the next phases of clinical testing which will involve the vaccination of thousands of volunteers, including frontline healthcare workers. If the candidate vaccine is able to protect these people, as we hope it will, it could significantly contribute to efforts to bring this epidemic under control and prevent future outbreaks.
“It is important to remember that this vaccine is still in development and any potential future use in mass vaccination campaigns will depend on whether WHO, regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made.”

GSK is working closely with the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) in the USA to assist with the design and to potentially support trials in other affected countries – Sierra Leone and Guinea – in the coming months. In parallel, GSK plans to begin large phase II safety trials in non-affected west African countries.

The candidate Ebola vaccine shipped today was co-developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a biotechnology company acquired by GSK in 2013. It uses a type of chimpanzee cold virus, known as chimpanzee adenovirus type 3 (ChAd3), as a carrier to deliver benign genetic material from the Zaire strain of the Ebola virus, which is responsible for the current Ebola outbreak in west Africa. GSK has been working with the NIH to accelerate development in response to the current Ebola epidemic.

Davos: UN launches $1 billion appeal for global Ebola response

Davos: UN launches $1 billion appeal for global Ebola response
21 January 2015
The United Nations today appealed for $1 billion needed for the first six months of 2015 to sustain the momentum to stamp out Ebola in West Africa, where ‘the epidemic has started to turn’ in all three of the worst-hit countries – Guinea, Liberia and Sierra Leone.

“We’re beginning to see an overall decline in number of new cases each week,” Dr. David Nabarro, the UN Special Envoy on Ebola, told a news conference in Davos, Switzerland, at the 2015 World Economic Forum, where global leaders from across business, Government, international organizations, academia and civil society are gathered for strategic dialogues on events and trends shaping the world.

Valerie Amos, UN Emergency Relief Coordinator, also welcomed the “early signs of reduction of Ebola in all three countries” but noted the need to remain vigilant.

And as the Secretary-General of the United Nations [Ban Ki-moon] said yesterday, complacency would be our worst enemy,” Ms. Amos, who is also the UN Under-Secretary-General for Humanitarian Affairs told reporters.

The appeal was launched by Ms. Amos and Dr. Nabarro, who are in Davos where there are some 20 scheduled events at the World Economic Forum devoted to the global fight against the Ebola epidemic…

Press Conference Needs and Requirements for a Global Ebola Response
Valerie Amos, UN Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, and David Nabarro, the UN Secretary-General’s Special Envoy on Ebola, present the latest Overview of the UN system and partners’ Requirements for the Ebola Response. This is an appeal for funds to support the efforts of the national governments of Guinea, Liberia and Sierra Leone as they identify and treat people affected by Ebola, ensure a rapid end to the outbreak, re-establish essential social services and improve people’s food and nutrition security. The appeal includes funds needed for enabling nearby countries to reduce their people’s risk of Ebola infection.

Download audio: http://webcasts.weforum.org/widget/1/davos2015?p=1&pi=1&a=66503

WHO: Ebola response roadmap – Situation report 21 January 2015

WHO: Ebola response roadmap – Situation report 21 January 2015
[Excerpt]
SUMMARY
:: Case incidence continues to fall in Guinea, Liberia, and Sierra Leone, with a halving time of 1.4 weeks in Guinea, 2.0 weeks Liberia, and 2.7 weeks in Sierra Leone. A combined total of 145 confirmed cases were reported from the 3 countries in the week to 18 January: 20 in Guinea, 8 in Liberia, and 117 in Sierra Leone.
:: Mali has been declared free of Ebola virus disease (EVD) after completing 42 days since the last case tested negative for EVD.
:: Surveillance and information sharing will be increased in the border districts of Guinea-Bissau, Côte d’Ivoire, Mali and Senegal adjacent to the 3 intense-transmission countries.
:: Each of the intense-transmission countries has sufficient capacity to isolate and treat patients, with more than 2 treatment beds per reported confirmed, probable and suspected case. The planned numbers of beds in each country has now been reduced in accordance with falling case incidence.
:: Similarly, each country has sufficient capacity to bury all people known to have died from EVD.
:: Guinea, Liberia and Sierra Leone report that between 89% and 99% of registered contacts are monitored each day, though the number of contacts traced per EVD case remains lower than expected in many districts. In the week to 11 January, 53% of new confirmed cases in Guinea arose from known contacts; in the period between 1 January and 15 January, 53% of new confirmed cases in Liberia arose from known contacts. Equivalent data are not yet available for Sierra Leone.
:: There are currently 27 laboratories providing case-confirmation services in the 3 intense-transmission countries. Five more laboratories are planned in order to meet demand. The mean time between sample collection to sample testing in the 21 days to 18 January was 1.37 days in Guinea, 2.03 days in Liberia, and 2.32 days in Sierra Leone, although several districts in Guinea have yet to report data.
:: Case fatality among hospitalized patients (calculated from all hospitalized patients with a reported definitive outcome) is between 57% and 59% in the 3 intense-transmission countries, with no detectable improvement since the onset of the epidemic.
:: A total of 828 health worker infections have been reported in the 3 intense-transmission countries; there have been 499 reported deaths. The incidence of health worker infections has fallen in Liberia and Sierra Leone, but rose in Guinea throughout December.
:: As an indication of community engagement, 71% of districts in Guinea and 100% of districts in Sierra Leone have a list of key religious leaders who promote safe and dignified burials. No data are available for Liberia. Incidents of community resistance to safe burials and contact tracing continue to be reported in all 3 countries, although they are most common in Guinea.

COUNTRIES WITH WIDESPREAD AND INTENSE TRANSMISSION
:: There have been in excess of 21,000 reported confirmed, probable, and suspected cases (Annex 1) of EVD in Guinea, Liberia and Sierra Leone (table 1), with more than 8600 deaths (outcomes for many cases are unknown). A total of 20 new confirmed cases were reported in Guinea, 8 in Liberia, and 117 in Sierra Leone in the 7 days to 18 January.
:: A stratified analysis of cumulative confirmed and probable cases indicates that the number of cases in males and females is similar (table 2). Compared with children (people aged 14 years and under), people aged 15 to 44 are approximately three times more likely to be affected. :: People aged 45 and over are almost four times more likely to be affected than are children.
:: A total of 828 health worker infections have been reported in the 3 intense-transmission countries; there have been 499 reported deaths (table 3)…

WHO: Statement on the 4th meeting of the IHR Emergency Committee regarding the 2014 Ebola outbreak in West Africa

Statement on the 4th meeting of the IHR Emergency Committee regarding the 2014 Ebola outbreak in West Africa
WHO statement
21 January 2015
The fourth meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (IHR) 2005 regarding the Ebola virus disease (EVD, or “Ebola”) outbreak in West Africa was conducted with members and advisors of the Emergency Committee on Tuesday, 20 January 2015.

This meeting was convened to review, in accordance with IHR provisions, whether the event continued to constitute a Public Health Emergency of International Concern and, if so, whether this warranted an extension or revision of the three -month date of the expiration of the temporary recommendations, which were first issued on 8 August 2014 and extended on 22 September 2014 and 23 October 2014.

Developments since the Committee’s last meeting were reviewed, including the most recent epidemiological situation. The Committee noted that the number of Ebola cases is decreasing in all three of the most affected countries.

Since the previous meeting, three countries have declared the end of Ebola transmission: Spain, the United States of America, and Mali. One case was imported into the United Kingdom of Great Britain and Northern Ireland (UK), in a health care worker who returned from Sierra Leone and was asymptomatic on exit screening and during travel; she became ill after arrival in the UK.

The Committee expressed concern that additional measures affecting travel, transport and trade that go beyond the temporary recommendations have been put in place in more than 40 countries.

Current response and preparedness activities were reviewed, as well as recent scaling up of the response. Priorities and strategies for moving towards zero cases were presented.

Guinea, Liberia, Sierra Leone, Mali and UK provided an update on and assessment of the Ebola situation in their countries, including progress towards implementation of the temporary recommendations.

Even though a few cases have occurred outside the three most affected countries, the measures recommended appear to have been helpful in limiting further international spread, including the exportation of disease from the three most affected countries.

It was the unanimous view of the Committee that the event continues to constitute a Public Health Emergency of International Concern. The Committee reviewed the temporary recommendations previously issued and stated that all previous temporary recommendations should remain in effect.

The committee provided the following additional advice to the Director-General for her consideration in addressing the Ebola outbreak in accordance with the IHR.

Recommendations for the most affected countries (Guinea, Liberia, Sierra Leone)
The Committee strongly reiterated the previous temporary recommendation on exit screening and highlighted the value of exit screening in these three countries. Exit screening remains critical for minimizing the risk of exportation of Ebola cases. The three most affected countries should maintain robust exit screening until Ebola transmission is confirmed to have stopped in these countries. The Committee again urged affected countries to provide WHO regularly with the number of people screened at international airports and the outcomes of exit screening. The international community should support a sustainable approach to this exit screening.

Recommendations for countries sharing borders with Guinea, Liberia and Sierra Leone
These countries should be conducting active surveillance, including in border areas, and engaging in cross-border cooperation, information and asset sharing, and continued vigilance for new cases. National governments should empower local communities that have land crossings at shared national borders to be part of these activities.

Recommendations for all countries
The Committee reaffirmed the need to avoid unnecessary interference with international travel and trade, as specified in Article 2 of the IHR 2005. The Committee noted that more than 40 countries have implemented additional measures, such as quarantine of returning travellers and refusal of entry. Such measures are impeding the recruitment and return of international responders. They also have harmful effects on local populations by increasing stigma and isolation, and by disrupting livelihoods and economies.

The Committee concluded that the primary emphasis must continue to be on ‘getting to zero’ Ebola cases, by stopping the transmission of Ebola within the three most affected countries. This action is the most important step for preventing international spread. Complacency is the biggest risk to not getting to zero cases. Continued vigilance is essential.

The Director-General thanked the Committee members and advisors for their advice and requested their reassessment of this situation within three months or earlier should circumstances require.