it was the eventful. it was tested in a different form. it is set up to be tested. in mali and other african countries.

it came out in literally up a couple weeks ago. we are now setting up for testing again advanced trial using this. the other candidate is a virus into which has been inserted the ebola glycoprotein jean. it was full be enrolled and this in collaboration with the department of defense, we are doing at the nih, other than doing it from the medical institute, by the department of defense, the united states army again, now in collaboration also with merck, you will be hearing more about that from julie. the company did involved in originating the public health agency of canada as i mentioned, dod with naid, they are role. america is involved in the

trial, was put on hold because of -- people get confused about that. four individuals had clear inflammation. that doesn't mean the end of the vaccine by any means. my house ups are very common. we saw it in a significant proportion of people when you give a live virus vaccine. you don't have to give it but you can see it as an individual. the question is what is that going to mean? that is why you have phase one trials so you can investigate that. the proposed half are two and this has been in close collaboration with the liberian health officials, a plan of a randomized double blind placebo controlled trial in liberia and a step which trial in sierra leone with at least two in

liberia, possibly one or two in sierra leone, working with the cdc to decide on that. the pipeline is therapeutic. i want people to appreciate that none of these have been shown to be effective. they have been given on compassionate use and we done not know if any of the more. mechanistic reconfigure out away they may work enough but you will never know when did they work and let me make a comment we will get a chance to discuss, the distribution in a trial in which not everybody gets a particular intervention is different when dealing with a vaccine that you are giving to an absolutely healthy person compared to a therapeutic when you are giving it to someone who may be drastically ill. when you think of the design of trial that is why the discussion is a good difference. very quickly zmapp, you heard about it, it has been given to several people on compassionate

use. three and i glycoprotein antibodies shown to produce -- protect monkeys. the ebola -- phase one trials that are on going. 3430, a nucleotide analog which protects monkeys against ebola, also in a case 1 trial. and the inhibitor developed for other viruses shown to have some activity against ebola and is now used -- not yet with ebola. this is an inhibitor that was brought in viral usage. it protect life and has not gone into a nonhuman primate. i show you is this, you can argue about the potential but despite the fact that they are given in compassionate use and/or in the face 1 trial doesn't mean they work and the critical issue is the balance,

the need for a therapeutic with a desperately ill person and the need to show that it actually works. and the first trials have been kicked off a couple days ago in the knee and sierra leone and liberia which is going to be determining whether the antibodies in the person's plasma who is recovered will be protected. we have put together with the people in emily and nebraska and adapted trial designs to take a look at a couple of these therapeutics with the control being an enhanced care. in other words he intensive replenishment and fluid and electrolyte balance so it is in the placebo because it is different from the situation in which you are giving the vaccine. i will hand it over, 12 minutes.

[applause] >> thank you very much. sorry for the glitch. >> thanks for the invitation. as you know, there's a long tradition of global health weather on the r&d side of things. or work on the other that scene. and different -- the different outbreak. it seems for the great and leading driving the community to

participate taking part and the tragic situation. and the next few minutes, talked-about tweeting. talk about some key enablers, get incentivize to buy to set pay, and share some learning and future looking ideas of how to be better if repaired in the future for situations like this. i would be happy to explain for anyone of you as we get into the q&a. >> the status in partnership with the nih which hasn't completed completion, they are very satisfactory voting safety,

also have three fully enrolled state run cities being conducted in the u.k. switzerland and molly, which include numerous responses available for the second week of january. i say this with precision, our perspective, we need to await the integrated analysis of all of these to use in the field. we also are planning on two trials in africa, one including 3,000 subjects and one in children and pediatrics involving 800 subjects. and the middle of january and phase 3 trials where we have the nih in liberia to participate in

what we described and participate in the cdc trial in sierra leone. those are the trials in collaboration in the special -- to see if we can have a good vaccine in protecting the short-term and protection on the long-range by providing a boost your, by combining our vaccine or one of the vaccines that are being developed. quite a comprehensive effort to that should deliver data and information before the middle of the year. if all goes well these trials are as they hope they will end in the best agency to put them together. during the trial it cannot happen without the vaccine. in the past four months we have

dedicated enormous resources from the organization to make sure we take the bench level process to manufacture the vaccines to where we can produce the vaccine and release the first love for the same trials before the end of the year in december if all goes well. then continue to produce vaccines in tens of thousands per month and hundreds of thousands per month in the millions and eventually participate in vaccination programs if they are important. and major challenges continued to face us in scaring the production of the vaccine,

vaccine and conditions in this vaccine are very challenging, and the virus, the vaccine, very important and established. or others. also great partnership to ensure we have the highest contingencies at the same time, the fastest possible track for usage. that is the status of the vaccine. the enablers, this section would not have any of the vaccines that are developed and partnerships with nih or the university of oxford for

pharmaceutical companies. it is really that he in the meeting next week but the companies here as i mentioned, worked together towards achieving impact. of the second thing that is important is to think forward about access and vaccines to the populations that need them and very pleased about the conclusions they have. as we mentioned there has been a critical meeting that took place at who to make shore all stakeholders come to a common unit, not that many countries come to a similar conclusion and key stakeholders and many

countries and countries -- at very important move for those efforts. and all around the ability, for all the stakeholders. one of my concerns is when clinical trials more importantly in this setting and contingencies, different diseases, in the events happening in the proclamation, to ebola they would have any vaccine, and the site for which

of these events, the background on the population is a major focus that we have and around liability, very pleased to extend the act of the ebola vaccine. and all the countries to materialize. in the future perspective, this is in the past four or five years, different tracts of ebola, good news on what is next. the community was taken by, quote, surprise when we have to divert their resources indicating whether discovering

the vaccines are manufacturing vaccines or whatever it is we are doing under emergency situations, manufacturing vaccines like we are doing here and dramatically development of vaccines for ebola. we think we are discussing this, that we should have a more pro-active approach to this. we should set out to have an organization and an approach that technically various technologies for immunization and vaccination to be highly accelerated for particular needs when the need arises, discovering vaccines, existing

potential threats. some manufacturing them. one of the things that we're very cautious about is the opportunity for disease events that have risen in the industry and community in general when we do some, this way we are highly inefficient but we also let go of other programs and we need a more efficient way. working on our companies to making these events available to work with stakeholders and older companies, not one on the return of investment, but assuming our shares and hopefully altogether be able to do this. >> thank you very much. >> i think you are in the

foundries. >> i do have something. >> okay. great. thank you very much for beginning today, to give you an update on the ebola vaccine. i would like to echo what you said. it said clearly it was a devastating disease. i see a lot of sympathy and working together the personal stakeholders and i am pleased to see there are no borders between companies to make is quite successful and the stakeholders, we would not have been able to be where we are today. the global health care co. and a

crisis that some of you realize, and allowed the mission of the global organizations we really want the capabilities and know how to fight the disease. we also have heavy investments, developing treatments and looking at objectives and also in terms of diagnostics going forward certainly offering 6-12 very important to have those diagnostics that allow you within minutes to know what you are confronted with whether it is the ebola virus or not so these are things we are active in. and we are very active with experts and and we settle such as project and foundations that

we have. when we look the week before, we had been working on this and thanks to partnerships from and i age, where the -- several generations of vaccines, we actually adjusted vaccinations schedules that were shown to be 100% effective when it was used, we see three vaccination regimens that turned out the 100% effective. when involved platforms we had fully in house with 35 and the other one -- with 126. as you can see below all this

placebo today, the survive of the animals which protect it. in view of the emergency we decided that we really want the development. it was initially focus on multilevel vaccine though we knew very clearly if we focused on single vaccine, focusing on the ebola strain that it would go faster. in addition by ourselves focusing on one of the vaccines and would produce another one, we felt it could shorten the time line significantly and that is something we achieved. what we actually have is the schedule itself composed of something being given with an outer factor and a boost being given -- the principle is we often have a to the best protection and year ago

protection with a combination -- the platform is that we used have been used extensively with commercial products, and more than 7,000 subjects vaccinated today. and safety profile and other factors shown to be well tolerated in programs we had like hiv. and continue to give good legitimacy to rate once the trial is the specific in search. one partner should we see in this is what we have invested in the past year, the manufacturing

process to give you an example, of violent scare, 150,000 doses we have so we already have substantial amount of vaccines in the freezer next year. production in the first results we hear from them and expectations and we are confident we will be able to release these marginally by next year. formulation was conducted in the past and the data using this platform, a platform up to two years to agree to one year.

and eventually dispatching in a frozen way, but could be using the classical distribution channels that have to be instituted to increase. this is how it works, the important prime boost and one of the reasons is indeed that you avoid the vector but certainly there is much more complex in the insistence behind it and the benefits of this boost. the way we are today is we are actually in -- december 23rd next week. we are in discussions in oxford and we really want to have a first patient in the early days generally, everything is aligned to happen and actually accelerate all of those to weed out of this and those days

should become available by mid february such as in that time frame we can start thinking around participating in a way that would allow you to fix it. with regard to production, could use $1 million next year but the recent devaluation on recent yields, could go up the next year up to $5 million, to a magnitude of 15 to $20 million and that is what i wanted to say. and we are convinced to go beyond the border of the companies here, we've put together all stakeholders to be successful and also hope the partnership of stakeholders works well now and from years --

a lesson going forward, areas where it is also high. thank you. [applause] >> the president of merck vaccine is. >> thank you for hosting this and my coat panelists's contributions and partnerships as we try to work for business. we try to put more context to the things we were talking about, at the end of the discussion. a predictable surprise. this is a disease that emanated from contact that hybrid of virus and spilled over, a million species, sometimes it's bills directly into people but

we have known about this system for a long time. we did note that it had reached the west coast of africa in quite the way it did but it is there now and there's no reason to believe we are not going to see this again so we have to be fully prepared for the possibility that even if we are able to quench the particular outbreak we are experiencing that this is not the last time we will deal with the ball. i don't mean to sound like a pessimist but it is important to have that perspective on what lies ahead with respect to the disease and this one in particular. we also need to really think about the issue of plausibility. from everything you heard and everything we have seen in the preclinical and early clinical studies that are going on, creating a vaccine for this pathogen is biologically plausible. that gives me a great deal of

optimism that even if the 1.0 vaccines we are working on today don't prove to be the best vaccine or the ultimate vaccine we need to g going because it is plausible to develop a safe and effective vaccine that can prevent infection either pre proposed exposure and that is something we need to stay the course, tenaciously stick to and sol for it. with respect to the vaccine merck is faring with these are early days of. this is the virus that is designed so that there is active cycles of replication of the vaccine vector when it is in the human host and that has the advantage of prompting a real immune system fast. we have to watch carefully for side effects so that we are alert to things that could

signal reactive -- something that would be a harbinger of a more serious issue down the road. i think we also anticipate the creation of a solution to this is going to have to be pragmatic. lives are at stake today while we are sitting here having this scientific conversation and we can't move at the pace we are used to moving. i don't know about my colleagues and other manufacturing pharmaceutical companies that this is an incredible destructor of business as usual because we have to be pragmatic. we can't take our time. we can't have a lot of conference calls and meetings and do all the stakeholders and key opinion leader engagement on and on. we have to do them in parallel. we have to work faster to move more people, mobilize more people to come to the table

inside the company let alone what is going on with incredible partnerships we are experiencing outside the company. i can tell you i think you said it really well about the disturbance of important pharmaceutical work that would otherwise be going on. the pull of this vaccine insights the passion of people certainly in the vaccine business that caught the entire enterprise of merck. we know it is the right thing to do and we have something to contribute and we can't do it alone and people are meaning into the opportunity to be a part of this process but at the same time we did not budget for is this. we didn't structure our company for this. this came along as a sudden a requirement and we have to step up to the plate and do our share but it comes at an opportunity for something we feel we have concerns about, doesn't change our commitment but it is

something we have to factor in and something we need to plan better for going forward into the future. the challenge we are facing is also about unprecedented partnership. i think in this world we are talking about partnerships, kind of aid buzz word. there are special partnerships going on here. one of them is the partnership between people who are traditionally competitors, that there's a much more robust set of partnerships happening between people who may share a broad agenda but are not used to working for each other that the transnational government partnership even in the u.s. government, the incredible partnerships, the leadership with nih, cdc, how wonderful it

is that there's already a commitment that this vaccine will be available to the people who need it most by creating macro investment commitment to bring forward. i think the beauty of that to me is the fact that underlying this kind of blend public health requirement is the trust that has been developed in the past several years as we have worked together on other problems. ..

people who have suffered deeply from this tragic outbreak, and the poignancy of being where we are today in the context of a predictable society not being able to do more faster to really contain this outbreak, and make their lives more secure and reduce the incredible human suffering that surrounds us, not just for the directly affected people but for all the people in the communities who don't have health services and whose lives have been so disrupted and whose economies have been so disrupted, and potentially the democracies will be so disruptive. but the other point, because i don't work for the government anymore, i can say this, is -- sorry, tony. it's the poignancy of having been here and done this before. we do not have to keep

reinventing the wheel. how many sars outbreaks we need to have? how many murders? somebody public health infectious disease outbreaks on the global skilled we need to experience before recognize that we can't have a topic response. went to have a sustained commitment and went to stick with it even when whatever the precipitating problem was goes away. to me that's the ultimate poignancy and i still share with you your final remarks about we need to lean into the future year, create new avenues, new tools and partnerships give him to sustain this effort over the long run. because i don't want to have to sit on a panel like this. as much as i've enjoyed this. thank you. >> very eloquent. >> thanks to much and appreciate being invited to join this conference today. doctors without borders has been responding to this outbreak

really since the start and raising the alarm and looking for more resources, especially in terms of teams and infrastructure. we realize as we often with many of emergency we are responding to we simply cannot have the tools we need, so we've taken a pragmatic approach to dealing with this outbreak in with our health care workers and more who have died in this than any other response that msf is given for as those effected commute into the best outcomes. to talk about some things msf is doing, these are the -- vis-à-vis trials. we will be releasing two of the trials this year, and we also going to run a third trial. our criteria very much was simply based on whatever safety efficacy data we had as well as to have been the supply of able and that has excluded the use of

some of the zmapp's and there's not a lot of supply. one thing i've been involved in a summit safeguarding that we consider important both in terms of the immediate term and ensuring that we can use the struggles for purchasing or compassion is for of the patients outside of the trials. we don't want a differential outcomes are patients. resort are also concerned about the medium-term issues in terms of the trial is proven to be successful that we can continue to ensure that there's supply available to patients if this outbreak and its continued. we are very concerned about the long-term access issues in terms of registration of products in terms of adequate supply, in terms of the affordability and the management of intellectual property. this is support him because as julie was noting this is something that's going to keep coming back and we're not sure in the future all of these are the responders will be there but

simply be an acceptance of the community that have to respond. we will need access in the future so we need to take steps now to ensure we can safeguard long-term access. in terms of vaccines, very early on alongside others. we very much worth thinking about the importance of vaccination potential to turn the tide of the ebola outbreak and navigation pragmatic attitude to pull up all the stops in terms of accelerating the trials and also terms of exporting the production recognizing that both for the company ever donors this would entail certain risks be taken in the short term and the medium-term. we tried to get a pragmatic approach to that. we do welcome the commitments have been made at gavi, the structure that's been before. one is around potentially the price of the vaccine which has not been specified actually in the strategy that has been put

forward. it's been left very big. to the extent we think these vaccine should be available, very close to the marginal cost is something we help gavi kenichi. related to that is would like to avoid overpayments for the vaccine's. there's a lot of contributions companies are making, also love contribution that governments are making to help pay for these vaccines. we certainly support direct compensation for the investment companies are making. in so far as we can ensure the vaccines are failed of its marginal cost. we should also member there are other incentives have been introduced the potential report companies were development of these vaccines including -- a very important sum of money to encourage companies to the vaccines or drugs against specific diseases. congress has just admitted legislation to include ebola. these are all very important but we need to make sure in terms of how this funding is being provided to make sure it is well coordinated as we've been discussing. the last issue about equitable

distribution. we are moving towards industrial scale production to a lot of these vaccine put in the short and medium term there'll be some problems into fighting adequate supply and to the extent we discover these vaccines are safe and effective, we want to make sure they are prioritized for the affected communities. we know there will be other interest in terms of securing supply potential for develop country but also issues in terms of how to manage distribution between different communities. we hope the w.h.o. can take in the central role. we are considering clinical trial in guinea with government of norway and other partners that we hope we can get off the ground by next march. moving out into issues around second generation products, certainly in terms of vaccine we would like to see a future vaccine to be more formal stable. -- thermal stable. this is the challenge for msf for many of the products the companies on the stage are currently selling to us in that

we are often unable to deliver them at very remote settings because we simply cannot move them out of chain and controlled temperature change. in terms of drugs, we think the show a lot of promise and a lot of interest in nsf we are concerned over to use of these drugs. potentially be used of biological samples from affected population in order to develop these products. potentially a concern that has arisen for us internally. we want to ensure that these materials are being used from affected countries at various concerned about access are triggered in terms of managing the supply. we want to ensure there's affordability to products and they're available again insufficient supply for the affected countries. just perhaps to end on some remarks, and just to note also that antibodies, the u.s. has expanded the orphan tax credit to the development of these antibodies which pay for 50% of clinical trial costs that

doesn't safeguard any of the access issues which were concerned upon. so demanding that they be affordable, they be available in sufficient supply. that's also the concern we have with the voucher. with all of the funding being provided it seems like none of that is being tied to ensuring access which matters to our organization. in the long-term we will be acquiring those product and using them into fuel for our -- using them in the field for our patients. just to end in terms of some additional thoughts. three lessons for us certainly in responding to this outbreak in terms of the drugs and vaccines. one is certainly about the challenge we continue to have a really insisting importance of access, whether the short or medium term or long term, that governments are providing links to access issues. our clinical trial partners often are not as familiar with these issues because that's not the course to think about these

in clinical trials and that's not normal for msf to be engaged in clinical trials. this is front and center as an operational organization trying to deliver treatments in the long-term. there's a lot of challenges there to normalize this in clinical development i think now and in the future. a second thing around transparency especially funding. a lot of money being put towards this and that's important to move from the famine to feast but we think we need to understand better how this funding is spent, what conditions are attached and how it works together. that's important for the us government which is offering so much money from different sources towards the response. the last issue i would note, this issue of the failure of our system of research and development. i work for an entity which launched in 1999 because we're concerned our system of research and development does not ensure the drugs and vaccines are affordable, better suited to the conditions we were in the face of agenda work. that's what this represents to us. we are faced with the same

situation we had 15 years ago. this failure is something we all own as a global community and is something which we're still not responded to. when you look at the vaccine which merck has now licensed in, that was developed by the canadian government. many years ago is licensed to a small manufacture for 200,000 canadian dollars to which nothing was done for a long period of time until this current outbreak. that is a failure. when i hear comments unfortunately of saying this is an opportunity cost, not expected, that confirms our concern. ebola is a concern for us. it is a public health problem and it needs to be front and center. they should not be thought of as opportunity cost. they should be front and center. that is what is required to have changes in the future. this is an emergency but so are other things.

so is a range of something of the neglected diseases. they all merit our attention. they require new ways of thinking and new ways of research and development. it's only if we can find new ways to develop drugs and vaccines are we going to prevent ink on these panels in the future because we're going to continue to face these challenges. as an operational organization we have to continue to respond and put our staff in affected communities suffering support of half of this outbreak. thank you very much. >> thank you, rohit. [applause] >> it's really striking how much soul-searching and introspection this crisis has stirred, and how much effort that innovation and changing business practices and modes of operation, how much all of you have been stretched in this period to do things that are outside the normal pattern. there's three issues i'd like to quickly touch on and then open to the audience.

one is the question of how these trials can be best carried forward. there is a debate going on now. there would be in an ideal situation an obvious preference for the classic randomized trial, approach, double blinded trial, and that will be attempted in many settings as we go forward. there's uncertainty though, we know the risk environment is complicated. we know the operational environment is complicated. we know that the acceptance by communities is very fundamental. in being able to move forward with trials. and so it seems to me that as we're entering 2015, expanded multiple, expanded trial, that this unresolved debate around how do you operate with greatest

adherence to principles of safety and efficacy while being pragmatic and adaptive to a highly challenging and highly urgent environment, how is that likely to play through? it's an honest and open set of challenges, for which i don't know that there's any immediate and clear answer. it would be useful to hear from all of you how you anticipate navigating the environment and moving forward. tony, do you want to say a few words about that? >> sure. first of all when you're dealing with trials, there is a balance as i said in my brief opening remarks about trying to get a product that is potentially going to be beneficial. to people as quickly as you can while making sure it is beneficial and not harmful. that's really the fundamental rationale for a randomized controlled double blind trial. i think that it can only be done with complete buy-in by the people involved and those responsible for them, the

reasons why we're now in our fourth visit to liberia in discussion with the liberia health authority about the feasibility and the advisability, or not, and the decision, or, as opposed or not to do a randomized controlled trial, fully being aware that the advantage of doing a placebo-controlled trial where not every single person gets the product is that from the standpoint of proving efficacy or not, it is really the only surefire way of doing that. you can have other trials. you can have cluster randomization. you could have step wedge, which are actually okay, but they are much less stringent from the standpoint of getting the data. the advantage of the other trial is that you can get everybody will ultimately gets the vaccine, so if it works, that's good. the other trial, the randomized

trial, you can probably get an answer of efficacy more quickly. once you get the efficacy, you're going to distribute the vaccine to everybody and anybody who might benefit from it. so there's the balance that ultimately if it works, everyone is going to get it. that's, you know, the framework. then you look at the advantages and the disadvantages. if, in fact, you are distributing a vaccine before you know it works, the advantage is that if it does work you get it to people quickly. the disadvantage is that you may not ever prove that it does work so when we are going to be sitting on this panel with the inevitable next outbreak, we will not know until we have a vaccine that works. that's the problem. the issue with the randomized controlled placebo trial is that some people are not getting it

right away, and there is this absolute understandable desire that if something is going to be beneficial, get it there as quickly as possible. i gave, and i will just finish with this because it's very important, i mentioned this at another seminar we had here about the issue of the difference between therapies that you make readily available for which i was the champion of during the hiv/aids versus a vaccine that you don't know works. and there's a big difference there because in one you are giving it to people who are perfectly normal and other you're giving it to people who have a terrible illness. the thing i will never forget, as i mentioned people may have heard of this, is that we have a vaccine for hiv that looked really good in an animal model. and it passed phase one, was really safe, no prohibited adverse

events. it even went into phase two a., and looked good. so the decision was that if you look at people as dramatic as it is, seven, 8000 people have died from ebola. over the last four days, 16,000 people have died from aids. so you could have made the argument, as soon as you had that safety data in the hiv trial, give it to everybody who needs it because it's a terrible, catastrophic pandemic. the only trouble is in the randomized control double-blind trial, we found out that there was a 41% increased risk of getting hiv infected if you were vaccinated with a vaccine. and it had nothing to do with behavioral changes. it had to do with the vaccine. so that's one of the reasons why when you're dealing with giving something to someone who is

otherwise normal person, even though they're at great risk, seriously balanced, and i don't know, steve, what the right answer is, but i do know that your least need too seriously -- you at least need to consider the pros and cons. and that consideration has to be with the people in the country are going to be involved with the vaccine. if they don't want it, they shouldn't get it. >> so we are in a negotiating, balancing out the urgency, the demands from the temerity and the leadership itself, that is all to be determined. as far as the mix of tools and approaches. >> would you like to say something? >> i'm very supportive for expressing, and i would like to add two dimensions to it. malaria kills between eight and

12,000 children every hour. we need to be very cognizant of the proportionality of this. a very important point about ebola is in january, february, march, april, the world doesn't have enough vaccine to immunize everybody. and the issue of having people at risk who are normal subjects, at the risk of acquiring ebola will exist outside. this is not a situation where we could potentially immunize a whole population but even if you wanted, you couldn't. so there will be people who participate in the trial and people who don't want to thank the question of keeping people away from a vaccine could be extended to the overall

population. for me, it's one of the reasons why, pragmatically there's nothing else you can do then provide vaccine to a smaller portion of the population. but, of course, engaging, explaining and have the agreement is ups will be paramount. it's also the reason why we are not favoring any one of the trial who does not -- working very hard to make vaccine available to all of them. we don't know which ones. >> i do have a concern, if you look at what's happening in liberia, had we introduced the vaccine a month ago we would be thinking -- we would be seeing a decrease in events now related to the vaccine when it's related to other things and, therefore, wouldn't know, we would know and we may be wrong. we need to have a very balanced, very persistent, very open

source, scientific discussion around it. >> this is really hard, and i just wanted to jump in here with perspective because i completely agree with tony, and i think participatory is the concept that needs to be emphasized. it's one thing to sit in a corporate headquarters and think we know the best way forward. it's a different thing to have a conversation with people who are on the front of the people in the affected countries who see medicine very different than we do and have a whole different cultural context in which they make decisions. that participatory element is really important. probably the thing that worries me is that even if we knew the vaccine works, will people take it? that's a problem that we see with the vaccines that a been around for as long as polio vaccine has been around. we have this incredible vaccine, it's frightening as ebola is, i

think it's going to be very difficult to help a population have trust and confidence in the product. so the more participatory the decisions are, the more transparent we all are, i think the better likelihood we are to bring whatever we can find, find helpful to be at the frontline what people need it. >> i fully concur. i think the major changes, will it be as accepted by local population, local committees they really get an acceptance of the people to participate in trial and be well prepared in trial that there will be ebola cases anyway, it can be approach every objective way and you -- start accusing the vaccines or whatever, the social thinking around how to involve the population and to work up any issues that arise.

very important to make these trials successful. one thing i would like to add to this, is on how we will go later on demonstrating for later vaccines, whether we will have to go -- [inaudible] when the vaccine becomes even more controversial or whether we should really start looking into bridging to whatever, certainly the discussion we still need to have a. >> msf, of all the positions here, is the one with the deepest on the ground extended contact and knowledge. how, i'm sure you are pulled in divergents directions in terms of this issue around ethics and trials and community relationships. how do you see this? >> the basic summary is it's about community engagement and acceptance, and we are build

basically on that basis. that's just part of the dna of the organization. it's not something just to be said. we have made a decision for our trials on drugs not to introduce randomized trial. it's a decision that was taken very early on in the organization that this is something as a medical provider that we would be unable to do and we are relying on approaches have been criticized elsewhere looking at the historic trends in some of these communities in terms of what has been the outcomes in terms of mortality rates. there's an understanding of the shortcomings but also the medical provider, and again it's because of this can we say we do not feel we would be able to engage in randomized controlled trial for the drug. again for vaccines i believe there are discussions of ways of trying, and begin for drugs because there's reasons within which -- right. >> steve, again the point you

make is an excellent point, is a big difference. people need to understand that between the drug and someone who's sick versus a vaccine. so it's no criticism of design of trials that can be anything from adaptive trials in any kind of trial, you need to really do what's acceptable and what you feel is the best so there's no space between them. >> now, one of the issues that has surfaced in this period is coordination, how to make sense, how to track and coordinate efforts, gavi took the step last week, that's to put itself forward. i would like to ask you to just say a few words. there's a microphone right here, around how does this step help put in place mechanisms that build confidence around the

coordinated effort looking forward? could you explain a bitid about that? >> i will do my best. thank you, steve, for hosting this panel. it's a terrific group of people that are really in the middle of all of this right now. it's great to be here. just to give everyone a bit of background, in september, our executive committee asked the secretary to physical look at ways to potentially have a role in the ebola outbreak. and in the crisis. basically over the last two months there has been a tremendous amount of work that has been done over this period, a lot of work with all of the people on the panel and pretty much every stakeholder that's involved in this process. that all came to a point at our board last thursday where the board discussed the idea of what that role would be.

and the decision was, a couple of things. the first was that everybody is related is this funding envelope of up to $300 billion, procurement of an ebola vaccine, once it's been deemed safe and effective by the w.h.o. and there's also another 90 million, up to a $90 million enevelope for two purposes. what is around the rollout of the vaccine was becomes available, and any other piece is the ground recovery of immunization systems. i think everybody is aware that, especially in the three countries that have been affected, immunization systems have been decimated, a huge reduction in immunization year when the time is right this country are going to have to rebuild, and we are going to be part of that solution for them. i think it's very important for people to understand, i think some people here know that we are just weeks away from our second replenishment, which is not about ebola, the number that

we're looking for $7.5 billion that was well before this crisis hit. so the numbers that we're talking about for ebola are in addition to what we are looking for replenishment. i think it's very important to know that that funding is additive and not part of our regular critical immunization work. what we are doing as far as the next step, we literally just made this decision four days ago, but the work has already started to really get ourselves in place to be ready when a vaccine comes about, four work streams have been created around the areas of the board's decision, procurement rollout, future outbreak, and the recovery of the system. so we are really working to ensure that these pieces are all set, so that when a vaccine becomes available we are prepared to roll it out.

and as far as the recovery piece goes, as i said i think countries are still in process of figuring out what they need to do. we are putting ourselves together so that when countries are ready to start rebuilding, that we are there to support it. as far as, i mean, we play, i think what is happening the last two months really shows the important role that we have around immunization but also around strengthen health systems around immunization's, and we are a small piece but i think just kind of going back to what everybody said, around partnership. we will play a certain role in the vaccine process but in order to ensure that it's really getting to people that need it, you know, we will rely on our partners on the ground, along with all of the other folks that are part of this process. >> thank you very much, natasha. there seems be a pretty strong