EBOLA [to 6 September 2014]
Statement on the WHO Consultation on potential Ebola therapies and vaccines
5 September 2014 —
[Full text; Editor’s text bolding]
After 2 days of discussion on potential Ebola therapies and vaccines, more than 150 participants, representing the fields of research and clinical investigation, ethics, legal, regulatory, financing, and data collection, identified several therapeutic and vaccine interventions that should be the focus of priority clinical evaluation at this time.
Currently, none of these vaccines or therapies have been approved for human use to prevent or treat EVD. A number of candidate vaccines and therapies have been developed and tested in animal models and some have demonstrated promising results. In view of the urgency of these outbreaks, the international community is mobilizing to find ways to accelerate the evaluation and use of these compounds.
Safety in humans is also unknown, raising the possibility of adverse side effects when administered. Use of some of these products is demanding and requires intravenous administration and infrastructure, such as cold chain, and facilities able to offer a good and safe standard of care.
The experts determined:
:: There was consensus that the use of whole blood therapies and convalescent blood serums needs to be considered as a matter of priority.
:: Safety studies of the 2 most advanced vaccines identified – based on vesicular stomatitis virus (VSV-EBO) and chimpanzee adenovirus (ChAd-EBO) – are being initiated in the United States of America and will be started in Africa and Europe in mid-September. WHO will work with all the relevant stakeholders to accelerate their development and safe use in affected countries. If proven safe, a vaccine could be available in November 2014 for priority use in health-care workers.
:: In addition to blood therapies and candidate vaccines, the participants discussed the availability and evidence supporting the use of novel therapeutic drugs, including monoclonal antibodies, RNA-based drugs, and small antiviral molecules. They also considered the potential use of existing drugs approved for other diseases and conditions. Of the novel products discussed, some have shown great promise in monkey models and have been used in a few Ebola patients (although, in too few cases to permit any conclusion about efficacy).
Existing supplies of all experimental medicines are limited. While many efforts are underway to accelerate production, supplies will not be sufficient for several months to come. The prospects of having augmented supplies of vaccines rapidly look slightly better.
The participants cautioned that investigation of these interventions should not detract attention from the implementation of effective clinical care, rigorous infection prevention and control, careful contact tracing and follow-up, effective risk communication, and social mobilization, all of which are crucial for ending these outbreaks.
The recipients of experimental interventions, locations of studies, and study design should be based on the aim to learn as much as we can as fast as we can without compromising patient care or health worker safety, with active participation of local scientists, and proper consultation with communities.
This will require the following crucial elements:
:: Appropriate protocols must be rapidly developed for informed consent and safe use.
:: A mechanism for evaluating pre-clinical data should be put in place in order to recommend which interventions should be evaluated as a first priority.
A platform must be established for transparent, real-time collection and sharing of data.
A safety monitoring board needs to be established to evaluate the data from all interventions.
All of these will require continued ethical oversight.
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WHO: Global Alert and Response (GAR) – Disease Outbreak News [to 6 September 2014]
http://www.who.int/csr/don/en/
:: Ebola virus disease outbreak – west Africa 4 September 2014
Meeting Video: UN Ebola Briefing
2 September 2014 :: 1:18
Deputy Secretary-General, Director-General of the World Health Organization (WHO); United Nations System Coordinator; MSF President; UNICEF ED, others.
http://webtv.un.org/watch/the-ebola-outbreak-in-west-africa-briefing-to-member-states/3763544442001
Additional WHO Content:
:: Ebola situation in Port Harcourt, Nigeria – 3 September 2014
:: Virological analysis: no link between Ebola outbreaks in west Africa and Democratic Republic of Congo – 2 September 2014
:: Ebola event management at points of entry: Interim guidance
WHO
September 2014 :: 11 pages:
WHO reference number: WHO/EVD/Guidance/PoE/14.1
pdf: Interim guidance: Ebola event management at points of entry
Overview
As the Ebola virus disease (EVD) continues to claim lives and put pressure on health systems in west Africa, its transmission across borders has prompted a need to manage suspected cases at Points of Entry (PoE).
The interim guidance document is intended for National Focal Points for the International Health Regulations (IHR)(2005)(1), PoE public health authorities, PoE operators, conveyance operators, crew members and other stakeholders involved in the management of Public health event.
The aim is to provide early detection of potentially infected persons; to assist in implementing WHO recommendations related to Ebola management; and to prevent the international spread of the disease while allowing PoE authorities to avoid unnecessary restrictions and delays.
:: Infection prevention and control guidance summary
Ebola guidance package
:: Infection prevention and control guidance for care of patients with Filovirus haemorrhagic fever
Infection prevention
:: Toolkit for behavioural and social communication in outbreak response
Social mobilization
:: Ebola and Marburg virus disease epidemics: preparedness, alert, control, and evaluation
Preparedness and response
CDC/MMWR Watch [to 6 September 2014]
http://www.cdc.gov/mmwr/mmwr_wk.html
:: CDC warns Ebola epidemic in West Africa is outpacing current response – Press Release
9/2/2014, 4:50 PM
CDC Director Tom Frieden, M.D., M.P.H. reported on his visits last week to Guinea, Liberia and Sierra Leone and called for immediate steps across nations to accelerate response to the Ebola epidemic in West Africa.
vaccines and global health :: ethics and policy 