WHO Advisory Committee Meeting On Experimental Ebola Treatments

 

# 9321

 

Although there are a number of potential vaccines and therapies being looked at as possibly being effective against the Ebola virus, none have been adequately tested for both safety and effectiveness.  Some interventions – like ZMapp, and blood transfusions from recovered patients – have been tried, but the extent to which they worked isn’t clear.

 

Figuring out how to use utilize these treatments in the midst of a raging epidemic – and still come away with data that can tell us if they are safe and effective – is a complex and time consuming task.

 

Today the World Health Organization has published a summary of a meeting held earlier this week by their Scientific and Technical Advisory committee on Experimental Ebola Interventions.  

 

While there is a paucity of data thus far, follow the link below to see a summary of where things stand with the testing of Blood products (Convalescent whole blood (CWB) and convalescent plasma (CP)), immunoglobulin (IG) from survivors, and pharmaceuticals.

 

 

 

WHO Meeting of the Scientific and Technical Advisory Committee on Ebola Experimental Interventions – Briefing note

Date: 13 November 2014
Place: Geneva, Switzerland

Following the emergence of Ebola virus disease (EVD) as a severe public health emergency for which no effective therapeutic or prophylactic interventions are available, the scientific community has proposed numerous experimental interventions, including: vaccines; convalescent blood and plasma; and medicines. None of these interventions have been evaluated for efficacy against EVD and therefore clinical studies to assess their safety and efficacy are required.

To facilitate and accelerate the appropriate clinical testing and generation of quality data of potential therapeutic interventions for EVD, WHO convened a meeting of the Scientific and Technical Advisory Committee for Ebola Experimental Interventions (STAC-EE) in Geneva, on 11-12 November 2014. The meeting was attended by experts in Ebola virus, preclinical and clinical testing, pharmacologists, sociologists, public health experts and regulators, as well as representatives from countries in West Africa.

STAC-EE reviewed the data on disease progression and the effect of some experimental products on 18 patients who were evacuated from West Africa to well-resourced facilities in other countries. Resulting data did not permit evaluation of efficacy of these interventions, and the comparatively high survival rate observed in these patients may be due to a variety of factors including the high standard of care they received.

Noting that the standard of care in Ebola affected countries varies between different treatment centres and even in the same centres over time while standard of care is being established, it was agreed that clinical trials should only be conducted in facilities able to provide consistently good standard of care. The number of such sites in West Africa, capable of providing such care and with suitable infrastructure to conduct clinical trials, is limited. Indeed, there have been far more proposals of products to be tested than availability of sites in which they could be tested. It was therefore imperative that STAC-EE prioritize the products for testing, mindful of time pressure and to avoid wastage of resources.

Collecting clinical data under the biosafety conditions required when treating Ebola necessitates careful consideration of the minimum data that should be collected, and since trials may be across multiple sites ideally such data collection forms should be harmonised. One minimal clinical data collection form was presented which will be used by several of the groups planning clinical trials. Other groups indicated a preference to develop a shorter and simpler form, but which would use several of the same data fields. These forms should be able to permit data pooling at a future date.

In addition, the STAC-EE highlighted the need for rapid Point-of-Care diagnostics to reduce the time gap between sample taking and results being received from laboratories.

(Continue . . . )

WHO Ebola Situation Assessment: Investigating Convalescent Therapies

Credit Wikipedia

# 9114

 

Three weeks ago, in WHO Statement: Consultation On Potential Use of Ebola Therapies & Vaccines, we looked at the recommendations of an expert committee who had met to discuss potential experimental therapies and preventatives for the Ebola epidemic. Topping their list of recommendations:

 

• There was consensus that the use of whole blood therapies and convalescent blood serums needs to be considered as a matter of priority.

Although still in limited use today, human and animal serum therapy was used extensively during the first half of the 20th century to treat a variety of infectious diseases, including anthrax, scarlet fever, measles, tularemia, diphtheria and rabies.

 

Plagued by a relatively high percentage of adverse reactions (serum sickness), and largely replaced by antibiotics or other drugs, its use has declined over time.

 

Convalescent serum is something we’ve discussed in the past for both novel flu and MERS (see MERS-CoV: The Long Road To A Pharmacological Solution).  Results, most recently in China for treatment of novel flu, have been mixed (Shanghai: Serum Treatment For H1N1), and so no one really knows how useful it would prove for Ebola. 

 

The idea is fairly simple, though. Blood is collected from patients that have been infected and have recovered from a viral infection, and through a process called plasmapheresis, blood cells are removed (using filters or a centrifuge) and the remaining antibody-rich plasma or serum is then used to treat ill patients. 

 

Technically, whole blood transfusions (correctly typed and cross-matched), plasma, or serum could be used. Serum is essentially blood plasma without Fibrinogen. 

There are significant challenges for all of these methods, particularly in very low resource medical environments , as described in the following panel from the WHO  BACKGROUND DOCUMENT POTENTIAL EBOLA THERAPIES AND VACCINES.

 

 

Today’s WHO statement (sent via email, not yet posted) explores the promise, and the challenges, of convalescent therapy, and telegraphs the release of a set of guidelines next week for its implementation.

 

Ebola situation assessment
26 September

Experimental therapies: growing interest in the use of whole blood or plasma from recovered Ebola patients (convalescent therapies)

Background
Ebola virus disease currently has no vaccines or medicines approved by national regulatory authorities for use in humans save for the purpose of compassionate care.

To date, the virus has infected 6242 people and killed 2909 of them. These figures, which are far greater than those from all previous Ebola outbreaks combined, are known by WHO to vastly underestimate the true scale of the epidemic.

The Ebola epidemic ravaging parts of West Africa is the most severe acute public health emergency seen in modern times. Never before in recorded history has a biosafety level four pathogen infected so many people so quickly, over such a broad geographical area, for so long.

On 11 August, a group of experts convened by WHO reached consensus that the use of experimental medicines and vaccines under the exceptional circumstances of the Ebola epidemic is ethically acceptable.

Following that advice, WHO convened (from 4–5 September) a consultation on potential Ebola therapies and vaccines.
The meeting was attended by more than 200 experts from around the world, including West Africa, though bans and restrictions on international flights to and from that region diminished the numbers significantly.

The meeting aimed to identify the most promising candidate vaccines and experimental therapies and map out the next most urgent steps to take.

The experts agreed to prioritize convalescent blood and plasma therapies for further investigation. That decision further stimulated already intense interest, with the result that new knowledge is expected to grow fairly quickly.
This assessment looks at what is known about the efficacy of convalescent therapies and the potential role they might play in improving clinical care and reducing the unacceptably high number of deaths.

The current evidence base: limited data – from 1976 up to now

Convalescent therapy was first used for a young woman infected with Ebola in the Democratic Republic of Congo (then Zaire) in 1976 – the year the virus first emerged. The woman was treated with plasma from a person who survived infection with the closely-related Marburg virus. She had less clinical bleeding than other Ebola patients, but died within days.

During the 1995 Ebola outbreak in Kikwit, Democratic Republic of Congo, whole blood collected from recovered patients was administered to eight patients. Seven of the eight recovered.

However, as the study did not include a control group, no firm conclusions could be reached concerning whether the treatment alone was responsible for the favourable clinical outcome or even contributed to this outcome in some way.
In the current outbreak, convalescent therapies have been used in a few patients. The numbers are too small to support any conclusions about efficacy.

In one well-known case, an American doctor, who became infected while working in Monrovia, Liberia, received whole blood from a recovered patient while still in Monrovia.

He likewise fully recovered, though it is not possible to determine whether that recovery can be attributed to convalescent therapy, the administration of the experimental medicine, ZMapp, or the excellent supportive care he received in the United States.

In another well-documented case, a foreign medical doctor, who was infected in Sierra Leone, has been improving following outstanding supportive care. He did not receive treatment with any experimental therapy.

In yet another case, an American doctor, who became infected while working in Liberia, was subsequently treated in the US. As part of that treatment, he received a transfusion of convalescent plasma from blood donated by the first case mentioned above. The infusion was well-tolerated.

Yesterday, he was declared by his attending physicians and the US Centers for Disease Control and Prevention (CDC) to be “virus-free”. He is weak but fully recovered.

Again, as he also received the experimental medicine TKM-EBV, together with outstanding supportive care, it is impossible to know which component of care contributed most – or at all – to his recovery.

The hospital where he was treated will share clinical lessons learned with doctors working in West Africa.

As the epidemic worsens, interest in convalescent therapies grows

WHO has been encouraged by the growth of interest in convalescent therapies as an already bad epidemic gets worse.

In the three hardest-hit countries, Guinea, Liberia, and Sierra Leone, health systems have begun to buckle under the pressure of closed or overflowing hospitals, the difficulties of staffing newly opened treatment centres, and the exceptionally large number of Ebola deaths among health care workers.

The number of cases continues to grow exponentially. The number of treatment beds is grossly and visibly inadequate. Good supportive clinical care is becoming increasingly difficult to implement.

The need to expand the current very limited arsenal of clinical tools is self-evident.

WHO has been approached by several donors, foundations, public health agencies, and development partners seeking guidance and advice.

Major questions need to be answered about the safety and efficacy of convalescent therapies, and the feasibility of implementation in countries with shattered health systems and an acute shortage of medical staff.

WHO is also being asked to assess whether rapid scaling up of convalescent therapy is feasible to an extent that could begin to reduce the estimated 70.8% case fatality rate seen consistently across the three outbreak sites.

Some partners and donors are asking for rough estimates of what needs to be in place to support rapid implementation on the largest possible scale. They have questions about the number of staff needed and their training requirements, safety risks and how to manage them, laboratory capacities and how to enhance them, specific needs for equipment and supplies, and what all of this might cost.

As initial supplies of these therapies will inevitably be limited, questions about which groups should have priority access also need to be addressed.

WHO is currently holding discussions with health experts in the Democratic Republic of Congo, Guinea, Liberia, Nigeria, and Sierra Leone. These discussions aim to identify practical needs for implementation and potential bottlenecks that could stand in the way.

One great appeal of this drive to assess and introduce convalescent therapies is the opportunity to strengthen basic public health infrastructures by helping these countries develop good quality blood services.

The list of common and severe health problems that could benefit from safe and well-functioning blood services is long – ranging from malaria, dengue, Lassa fever, and yellow fever to complications of childbirth and injuries following accidents and traffic crashes.

The current situation is so dire that, in several areas that include capital cities, many of these common diseases and health conditions are barely being managed at all.

 
Technical guidance for experts

Early next week, WHO is issuing new interim guidance on Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion during outbreaks.

The document is addressed to national health authorities and blood transfusion services.

WHO Statement: Consultation On Potential Use of Ebola Therapies & Vaccines

# 9044

 

The WHO press conference is still ongoing, but the World Health Organization has emailed out a statement (see below) that summarizes the findings of the two-day consultation on the use of experimental Ebola drugs and vaccines.

Audio files on the press conference (and later video) should be available later this afternoon at

http://www.who.int/mediacentre/en/

 

For now, the most immediately available experimental therapy – at least in some facilities capable of doing it safely -  is the use of convalescent serum harvested from recovered patients.  I discussed some of the technical details of this type of treatment yesterday, in a preview called WHO Consultation On Potential Ebola Treatments & Vaccines.

Safety, but not efficacy data on the two vaccines under development should be available by November.  Assuming that small-scale study goes well, experimental vaccines could be offered to a limited number of health care workers in a matter of months.

 

 

Statement on the WHO Consultation on potential Ebola therapies and vaccines

5 September 2014

After two 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 two 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, location 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.

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.

WHO Consultation On Potential Ebola Treatments & Vaccines

 

 

# 9037

 

 

Although we won’t know the results until the post-meeting press conference tomorrow (Friday, 5 September, at 18:00 CEST 12:00 EDT), today and tomorrow the World Health Organization is convening a consultation of international experts to discuss potential Ebola therapies and vaccines.

 

Given the extent of the Ebola outbreak in West Africa, a little over three weeks ago (see Ethical Use Of Experimental Drugs In Ebola Outbreak ) the WHO released a statement basically saying  – `Yes’  – untested experimental drugs can be ethically used in this Ebola outbreak provided it is done under specific conditions and guidelines.

 

In addition to the high profile use of the experimental monoclonal antibody ZMapp (see WHO Update: Anecdotal Evidence On Experimental Ebola Drugs) and the start this week of Ebola Vaccine testing (see NIH To Launch Trials On Ebola Vaccine Candidate), we’ve also see a flurry of far less reputable solutions being promoted by various factions – including nanosilver and homeopathic remedies.

 

Almost immediately the FDA warned consumers about fraudulent Ebola treatment products and the WHO began to aggressively discount these `cures’ on their twitter account.

 

Also, in an attempt to dial back some of the excessive media hype over what are unproven and untested drugs, we saw the WHO Warn Of `Unrealistic Expectations’ Over Experimental Ebola Drugs a couple of weeks ago.

 

The bottom line is, right now, there is no treatment or vaccine for Ebola that is proven both safe and effective, and the handful of experimental drugs that are available for testing are in very short supply.

 

This week’s meeting  will focus their attentions on 8 therapies and two vaccine candidates that have shown the most promise. 

 

 

First this summary from the WHO, then I’ll be back with more on the drugs on the table.

 

Consultation on potential Ebola therapies and vaccines

Place: Geneva, Swizerland
Date: 4-5 September 2014

The current west African Ebola outbreak is unprecedented in size, complexity and the strain it has imposed on health systems. There is intense public interest in, and demand for, anything that offers hope of definitive treatment. A range of unproven interventions-blood products, immune therapies, drugs and vaccines are under different stages of development but none have yet been licensed for standard use.

In early August, an expert panel convened by WHO concluded that, in the particular circumstances of this outbreak, and provided certain conditions are met, it is ethical to offer such unproven interventions as potential treatments or for prevention of infection.

This week, on September 4-5, WHO is bringing together technical experts from the groups developing Ebola interventions along with people working to overcome Ebola virus disease including policy-makers from Ebola affected countries, ethicists, clinicians, researchers, regulators and patient representatives.

The purpose of this meeting

• Review and evaluate the current state of development of interventions for Ebola virus disease (therapies and vaccines).
• Agree the overall objectives for a plan for evaluation and use of potential interventions.
• Identify and identify the most important actions that need to be taken.
• Establish what support is required.

 

The following charts come from the WHO  Background document on potential Ebola therapies and vaccines.

 

One of the therapies under consideration is something we’ve discussed in the past for both avian flu and MERS (see MERS-CoV: The Long Road To A Pharmacological Solution). It is called convalescent plasma, and its roots go back to Fibiger’s trial of serum treatment of diphtheria at the end of the 19th century. 

 

While  a bit more complicated in reality, in theory it is a pretty simple idea:

 

Blood is collected from patients that have been infected and have recovered from a viral infection, and through a process called plasmapheresis, blood cells are removed (using filters or a centrifuge) and the remaining antibody-rich plasma is then used to treat ill patients.

A variation of this therapy is also under consideration.

 

Several antiviral drugs are also under consideration, including:

 

Rounding out the therapies are Interferon (commonly used to treat chronic hepatitis and multiple sclerosis), and ZMapp.

 

Finally/ you can see a List of participants to this meeting.

WHO Update: Anecdotal Evidence On Experimental Ebola Drugs

 

# 8982

 

With the happy release today from Emory University Hospital of two Americans who were being treated for Ebola virus infection – both of whom received one of the few doses of ZMapp, an experimental monoclonal antibody cocktail – everyone is wondering just how much of an effect these drugs may have had on their outcome.

Today the World Health Organization has released some very preliminary, anecdotal evidence regarding its use in 5 cases; the two Americans and three healthcare workers in Liberia.

The good news . . . in addition to the two Americans that have recovered, all three Liberian HCWs are showing marked improvement. 

The bad news . . . that exhausts the supply of this drug, and it may take months before additional doses can be manufactured. 

While there are a handful of other investigational drugs out there, they are untested in humans, and are also in very short supply.  There are also serious logical and ethical challenges ahead in the distribution and use of any untested therapies (see WHO: Full Report Of Ethics Committee On Experimental Drugs For Ebola).

 

 

Anecdotal evidence about experimental therapies

Situation assessment - 21 August 2014

Clinicians working in Liberia have informed WHO that 2 doctors and 1 nurse have now received the experimental Ebola therapy, ZMapp.

The nurse and one of the doctors show a marked improvement. The condition of the second doctor is serious but has improved somewhat.

According to the manufacturer, the very limited supplies of this experimental medicine are now exhausted.

ZMapp is one of several experimental treatments and vaccines for Ebola that are currently undergoing investigation. At present, supplies of all are extremely limited.

On 4–5 September, WHO will host a consultation on potential Ebola therapies and vaccines in Geneva. The consultation has been convened to gather expertise about the most promising experimental therapies and vaccines and their role in containing the Ebola outbreak in west Africa.

The expertise among the more than 100 participants is wide, ranging from pharmaceutical research and the clinical demands of Ebola care, to expertise on ethical, legal, and regulatory issues. More than 20 experts from west Africa are expected to attend.

Issues of safety and efficacy will be discussed together with innovative models for expediting clinical trials. Possible ways to ramp up production of the most promising products will also be explored.

Presentations about the real conditions and challenges in affected African countries are intended to anchor all discussions and shape the consensus advice that is expected to emerge.

WHO media contacts:

Gregory Hartl
Telephone: +41 22 791 4458
Mobile: +41 79 203 6715
Email: hartlg@who.int

Fadéla Chaib
Telephone: + 41 22 791 3228
Mobile:+ 41 79 475 55 56
Email: chaibf@who.int

 

 

For more on ZMapp you may wish to revisit CDC FAQ On Experimental Ebola Treatments & Vaccine Development

WHO: Full Report Of Ethics Committee On Experimental Drugs For Ebola

# 8965

 

The extraordinary spread of Ebola in the West African nations of Guinea, Liberia and Sierra Leone – and the spillover into the highly populated country of Nigeria – has led to numerous calls for the use of untested, experimental drugs on humans in the region.   We’ve already seen one drug – ZMapp – used on a handful of patients.

 

Last week the World Health Organization convened an ethics committee to consider the idea (see WHO Statement: Ethical Use Of Experimental Drugs In Ebola Outbreak) and announced that – under certain conditions – such use would be ethical.

 

The intent was to allow a handful drugs and vaccines currently under investigation for the treatment of Ebola - those with at least some reasonable expectation of being effective - to be given a “compassionate use” waiver so they could be used outside of a clinical trial.  

 

On Friday, in an attempt to dial back some of the excessive media hype over what are unproven and untested drugs, we saw the WHO Warn Of `Unrealistic Expectations’ Over Experimental Ebola Drugs.

Proving that no good deed goes unpunished, almost immediately we began to see reports of everything from herbal remedies to homeopathic `cures’ to `Nano Silver’ ( even holy water)  being offered as potential treatments or preventatives for Ebola.

 

Last week the FDA warned consumers about fraudulent Ebola treatment products and the WHO began to aggressively discount these `cures’ on their twitter account.

 

While some of these `cures’ are likely harmless in and of themselves, they could lull some into believing they are being `protected’ against the disease when they are not, or to avoid medical care which could actually make a difference in their outcomes.  Others – like the `salt water cure’ -  have already claimed lives, leading the WHO to tweet:

.

 

Yesterday the WHO published the full report from the Ethics committee on the use of Experimental drugs in this Ebola outbreak, which you can access at the link below:

 

Ethical considerations for use of unregistered interventions for Ebola viral disease

Report of an advisory panel to WHO

 Authors:
WHO

Publication details

Number of pages: 10
Publication date: 2014
Languages: English
WHO reference number: WHO/HIS/KER/GHE/14.1

Downloads

• Download the report

Overview

West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation to consider and assess the ethical implications for clinical decision-­making of use of unregistered interventions that have shown promising results in the laboratory and in animal models but that have not yet been evaluated for safety and efficacy in humans.

Related links

• Publications on Ebola virus disease
• Technical information on Ebola virus disease

WHO Statement: Ethical Use Of Experimental Drugs In Ebola Outbreak

 

# 8942

 

While a press conference is scheduled for later this morning (EDT), the World Health Organization has released the following statement basically saying  – `Yes’  – untested experimental drugs can be ethically used in this Ebola outbreak provided it is done under specific conditions and guidelines.

 

 

Ethical considerations for use of unregistered interventions for Ebola viral disease (EVD)

Summary of the panel discussion

WHO statement

12 August 2014

West Africa is experiencing the largest, most severe and most complex outbreak of Ebola virus disease in history. Ebola outbreaks can be contained using available interventions like early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control. However, a specific treatment or vaccine would be a potent asset to counter the virus.

 

Over the past decade, research efforts have been invested into developing drugs and vaccines for Ebola virus disease. Some of these have shown promising results in the laboratory, but they have not yet been evaluated for safety and efficacy in human beings. The large number of people affected by the 2014 west Africa outbreak, and the high case-fatality rate, have prompted calls to use investigational medical interventions to try to save the lives of patients and to curb the epidemic.

 

Therefore, on 11 August 2014, WHO convened a consultation to consider and assess the ethical implications for clinical decision-making of the potential use of unregistered interventions.

 

In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.

 

Ethical criteria must guide the provision of such interventions. These include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.

 

In order to understand the safety and efficacy of these interventions, the group advised that, if and when they are used to treat patients, there is a moral obligation to collect and share all data generated, including from treatments provided for ‘compassionate use’ (access to an unapproved drug outside of a clinical trial).

 

The group explored how the use of these interventions can be evaluated scientifically to ensure timely and accurate information about the safety and efficacy of these investigational interventions. There was unanimous agreement that there is a moral duty to also evaluate these interventions (for treatment or prevention) in the best possible clinical trials under the circumstances in order to definitively prove their safety and efficacy or provide evidence to stop their utilization. Ongoing evaluation should guide future interventions.

In addition to this advice, the panel identified areas that need more detailed analysis and discussion, such as:

• ethical ways to gather data while striving to provide optimal care under the prevailing circumstances;
• ethical criteria to prioritize the use of unregistered experimental therapies and vaccines;
• ethical criteria for achieving fair distribution in communities and among countries, in the face of a growing number of possible new interventions, none of which is likely to meet demand in the short term.

A report of the meeting proceedings will be available to the public by 17 August 2014.

 

 

While all currently existing doses of the monoclonal antibody cocktail ZMapp have either been used, or already slated for use, there are other experimental drugs in the pipeline, and an experimental vaccine could be available (albeit, only briefly tested) by next year.