Perna serve this Community General the armys material for nearly four years leading 190,000 military, civilian and contractor employees with a mission to provide logistics, sustainment, maintenance for globally deployed army. General perna is a career logistician to estimate complex supply distribution and Maintenance Operations in multiple combat tours with on the joint force and serve as at the national supporting department of defense supply and Distribution Efforts so as this with the back and its easier when he was selected for this critically important position. General perna graduated from the Valley Forge Military Academy and has a masters degree in logistics from the Florida Institute of technology. General perna will provide introductory comments and then befuddled by dr. Hepburn, ahead of Vaccine Development. Following dr. Hepburn general perna will come back specifically to talk about Vaccine Distribution and then we will move into a questionandanswer period that ed and i asking questions and then after that we will turn to your audience questions and thats what makes it so important that you in your questions, so we can get to your questions. Thats our plan and general perna i now turn the floor over to you. Thank you for that very gracious welcome. Its a real honor for myself and dr. Matt hepburn to be here and talk to the Heritage Foundation group. First and foremost, its just an honor to colead of this task force with as you said a mission to develop, manufacture and deliver safe and effective vaccine to the American People. First and foremost though, i just want to highlight this is a whole of america approach. In that light i would be remiss if i did not introduce to the conversation here my other colead. Because without him, without all that he brings to the table, without his leadership and direction, we would not be successful. That individual is dr. Moncef slaoui. Truly a coleader with me. He serves as a chief science adviser, and every day i learned from him, and i am outlaw at what he brings at all when he brings to the task force here. His efforts, tireless and demonstrated by the progress we made public when you make a difference for us. In my opinion, deserves the most credit for our success. With that i say though this as a whole of america approach, and we will exceed because of the unparalleled expertise of health and Human Services scientists and logisticians, department of defense planning and logistics capability as well as american industry ingenuity and innovation from the academia. Its this collective effort that will really ensure we are successful in our endstate, and im proud to be a part of it. I would like you to think of it this way. The worlds best scientists and doctors working beside the worlds best military with the support of american industry and academia, that is operation warp speed. And we really proud to be working together as a collective team to drive towards a solution of safe and effective vaccine for the American People. And i am very confident that we are going to be successful to this end. And today we would like to talk to you a little bit about our approach and where we are at in this Herculean Task that weve been working on for the last four to five months, and we are really just at the brink of finally seeing the fruits of our labor. So more to follow from the but i took it back over to you, generals for. Tom spoehr. Great. General perna, thanks much. Ed, wider to take it from you . If i could introduce dr. Hepburn. He has an undergraduate degree at his medical degree from Duke University and a 23 a 23 year r in the United States army, and in that career he has had extensive experience in developing vaccines and therapeutic solutions, particularly against current future potential biologic threats, including serving as director of medical preparedness on the White House National security staff from 20102013. Also serving as Clinical Research director for the u. S. Army medical Research Institute for Infectious Diseases from 20072009. So he comes to his current position as the Vaccine Development lead for operation warp speed with quite a depth of experience in this area. Dr. Hepburn, thank you so much for being with us. It is just a privilege to be here and certainly looking forward to answering the questions, and we will get there soon. I want to limit my comments actually to the probably the most important question, at least the question i i receive most often, whether its at my daughter texting me from college or all of these different Public Meetings that weve had and communications over the last six months or so. And the simple question is how can you achieve the impossible . How can you take a Vaccine Development process that typically can take five years, eight years, ten years and truncate that into the timelines of operation warp speed . I want to basically put my answer into four categories and hopefully i can convince you that, number one, we made incredible progress so far, but that we can meet the ambitious challenge of operation warp speed. So theres four categories of how we do it. The first is in terms of Vaccine Technology. Its very helpful to point out that the efforts that have gone on for decades in terms of developing vaccines, we stand on the shoulders of giants, of the people that worked on polio, measles, the smallpox eradication campaign, all of that that we learned in terms of how to develop vaccines. Theres been massive progress even before we started operation warp speed in terms of how you can accelerate Vaccine Development. Theres been investments. This is a key point that this site and Technology Investment payoff, sort of does. These are investments that have been made by health and Human Services come with the National Institutes of health and very proud of duty investments especially at darpa but elsewhere. Investments, how can we make vaccines at record time . [inaudible question] on weight, especially the process . These investments were used for ebola, in the ebola vaccine developer processes and not feel like they are really paying off. Thats how we are in phase three Clinical Trials now. Because of decisions, because of those investments and those technologies that were started in the spring that are now really paying off, both for their ability to be developed quickly and prove that the work in animal models, but also that they can be manufactured at a very large scale. The second point is in terms of manufacturing. Weve talked about this a lot but i want to highlight not just one point but two. What highlight is instead of doing the typical parallel process of Vaccine Product Development we do a Clinical Trial in the need to cite to manufacture on a larger scale, and another clinic Clinical Trial in the larger scale, tht we run this processes in parallel, and will make investments where large amounts of vaccines are being made much sooner. It is possible that some of those vaccines if they turn out not to work that we will not use those doses, but by those investments were able to have millions of doses available much sooner than we ever would. But i think the second part that doesnt highlighted as much is really the dod of bringing together the best of the department of defense and health and Human Services. By bringing as we talked about in the introduction, the supply and logistics expertise of a globally deployed force, and applying that to the critical supply chain issued a potentially critical shortages in vaccine manufacturing, critical equipment being delivered months earlier than it otherwise would. That is massively accelerated our vaccine manufacturing timelines. The 13 space of Clinical Trials, and i want to put stuff on this a little bit because i think everybody hopefully has been tracking both the astrazeneca and the other Clinical Trials been given the green light. They are to proceed from the fda. Both of those products have been on a safety pause and that safety pause has now been withdrawn but also emphasizes very much the prioritization that with safe and effective vaccine, that we are following the highest ethical standards to ensure that these vaccines are safe, and that those Clinical Trials are conducted to the highest regulatory medical standards as well. So the vaccines are back on track. These are not small Clinical Trials come again in it typical Product Development you may see a vaccine trial of lets say 5000 volunteers or maybe 8000 80 volunteers. Our standard has been 30,000 volunteers in our Clinical Trials. Thats because we want to gather as much Safety Information as we possibly can, and we also want to know if they work. With the more people you enroll, the sooner youre going to be able to evaluate the effectiveness. What we have done so far, and to think again most of you have probably tracked this, that moderna has not completed their phase three Clinical Trial in terms of 30,000 30,000 patientr 30,000 volunteers in all. Pfizer is still in building but they are about 40,000 volunteers now. What that shows you, for me, i dont know if this message is appreciated, but i but i want o emphasize, is that that shows me that over 60,000 americans have decided to say, i will volunteer. I do know if im going to receive the vaccine or i may receive a placebo, but im going to do my part in fighting this pandemic. I think we feel extraordinary appreciation for the volunteers. But today as i mentioned the astrazeneca trials are going to need another many thousand volunteers for each one. So were hoping we can send the message to the participants in this meeting as important in volunteering for vaccine Clinical Trials, and to encourage, and courage of those. Very proud of that spirit of volunteerism that we see in america. We also always emphasize the word volunteer means it is a personal choice and no one of you and makes the choice individually. But we think this thing you and many others are great opportunities to strongly encourage people to look into the opportunity. Let me give you one more specific example. Were having multiple sites in our Va Medical Centers that will be enrolling. And for our nation veterans this is another way that they can continue to serve in this way fighting the pandemic as a volunteer. My final point among those four on how we can achieve the impossible is through teamwork. I think this session is called fighting the pandemic. Were fighting the virus and the way we fight the virus is really getting the best from all of us. What we have seen is extraordinary integration and cooperation between our department of defense and her health and Human Services. Its the best that are covered has to offer. But when general perna mentioned the whole of nation, all of us fighting this together, the public, the public sector, the private sector, the Foundation Come everybody altogether finding that virus, i i seen se of the best teamwork ive ever been a part of as part of operation warp speed and it is the essential for the ingredient on how we achieve the impossible fourth ingredient. Thank you. Dr. Hepburn, thank you so much for that. I am not going to invite general perna to come back to make some very specific remarks regarding Vaccine Distributional over to you, sir. Thank you, sir. What a powerful update my dr. Hepburn. I great teammate that ive just been really blessed to work with over the last five months. Matt, thank you. I would like to touch on, quickly hit where dr. Hepburn talked about manufacturing. I know its not lost anybody listening to this conversation, but in order to really take the risk in manufacturing, we had to do a lot of things parallel. He described i thought incredibly well the risks that we took it that we proceed with six vaccines while simultaneously implementing the manufacturing capacity that is required to meet our mission. So just simply said, right, we had to make sure that we had the right capacity to manufacture the vaccine, which we didnt have five months ago. What we have done is weve added, actually added brickandmortar come in the city. In other words, we have built facilities from the ground up to produce a vaccine. We have garnered all the materials required to produce the six vaccines. Not only to execute trial, trials, but also to bring it up to scale in full manufacturing for eventual distribution to the American People. And then we had to accumulate the right equipment from all the manufacturing that we put together. And then the last stage of that was making sure with the right workforce that was trained and ready to produce and actually manufacture and go finish the vaccine. So really a remarkable task on its own in an effort what we did is we did implement the federal production act authorities with ows through the sector of Human Services and secretary of defense. Today weve implemented 12 with industry and we are working eight more. And it is, this effort that has allowed us to prioritize, contracts can prioritize material, authorize control of skiers and critical material and then drive industry to expand production and supply resources, which i think will be at the end of the day really critical to our overall success. We received nothing that absolute support in this light, whether it was permission from hired to do so or the execution by our Industry Partners to do daytoday business. Really remarkable effort collectively by the again whole of america highlighted particularly this part by industry. So lets assume that we will have vaccine available where sites will drive the safety and efficacy of vaccine as dr. Hepburn spoke about. Lets assume that with quantities of vaccine available to go upon fda approval. What is next, right . It goes without saying, the distribution of the vaccine across all of america to include territories and major cities, large metropolitan areas, and its just a Herculean Task all on its own. What do we do . We thought through the process, there were many courses of action, but at the end of the i made the decision that we were going to utilize the commercial industry that was most capable of implementing this task, right . There were three Large Companies all capable, all three of them are playing a role in Vaccine Distribution as well as therapeutic distribution but the primary industry partner for distribution will be the casting. Wellversed on how to do this. At the end of the day i chose it because they know how to do it. They have experience doing it. At the end of it we want to transition to them down the road for routine efforts and then third and most importantly is that the states are very culpable with dealing with the commercial industry as we do all sorts of vaccines and therapeutics throughout the year accordingly. And so in fact, i just dr. Slaoui and i were just visiting with mckesson yesterday in tennessee, memphis, tennessee, and we get to see firsthand a brandnew distribution warehouse thats included that can go down to minus 80 a 20 and then have facilities really distribute across america. Mckesson will partner with fedex and with ups for distribution not only america but around the world as well as local farmer, walmart, cvs, walgreens, programmers, et cetera to ensure that distribution can reach everybody. For tenets of the Distribution Strategy that he gave the team as we are working, planning is first and foremost we need to understand, when you do visibility and control of all vaccines. We need to know where every bottle was, whether was in the factory or it was on a truck or it had been distributed down to at administration site. We must have 100 accountability of all vaccines every day. Second, we must be able to track the uptake of vaccine to persons out in america. Two reasons for this. First and foremost, because five of the sixer two does vaccines. Vaccines. We need to make sure that people are registered to the vaccine that they were administered, and that there is failsafe checks and balances to make sure when they come back 20 21 or 28 days later that they get the right vaccine for their second dose. The second point was we want to manage the flow of vaccines to the American People. Initially, we are going to have tens of millions of doses available come december. That come january, february, march it will quickly and exponentially increase hundreds and millions of doses. So we will be essential that we maintain the right flow of vaccine to the American People. Third, we must make sure that we have traceability of the vaccine and that we know where the vaccine is going at all times. It will be a hot commodity, of course, and we needed to get to places where it will be distributed based on state priorities and requirements in accordance with the state and effectiveness of the vaccine. And then last, i want to be able to cover all parts of america, whether you are in the pacific in a remote islands, in the pacific, or down in, you know, in the atlantic. We want to be able to get to those islands. We want to be able to get to all of america whether its in the metropolitan cities or rural america, and we want to be able to make sure we can distribute to those american citizens who are overseas serving in the department of defense or state department, et cetera. So we to have coverage. Those are the four four major s for our planet. The last thing i will leave you with before turning back over for questions, this is different as we distribute this vaccine than a normal routine execution of Something Like influenza vaccine. The distribution of influenza vaccine on an annual basis is a poll method. In other words, pharmacies, doctors offices, hospitals or register and request certain amount of vaccine and it will be delivered to them directly right industry. What we have done since we had purchased these doses from industry, what were going to do is push. Were going to allocate vaccine doses to all of america simultaneously, and doesnt doses become available, we are pushing down and out through the United States of america. Eventually this will transition to a poll, but probably not likely in the earlier than march april time frame. We must ensure that we have very intricate and integral Distribution Process to meet the four tenants as i described, be able to ensure the constant flow of vaccine is available and then make sure everybody gets the right vaccine at the right time. That concludes my comments, and i am really grateful and welcomed to any questions you might have. Great, general perna, that was awesome. We are now going to go to some questions from ed and i, and the questions are rolling in from the audience and we will quickly cut to those and will just ask a couple to get things window. My first question is to you, general perna, and you are humble man and a know you dont like talking about yourself frankly, but this is really a personal kind of question. You are weeks away from retiring from the army after a distinguished 39 year career, army career, when you you got a call from the president that he wanted you to help lead operation warp speed. Im guessing many of the listeners on this webinar might face a a similar moment when ty are unexpectedly hit with a new task, a new mission that they probably never do wildest dreams expected to face and that the pivot to a new environment, a new set of challenges. I know they would love to hear from you, you know, how did you get this news . How did you get your head around this new mission, and how did you prioritize which had to do first in this new admittance mission that you were given . What a great question. I still remember, we all have those moments we know exactly what you were. I know exactly where i was, and susan and i were transitioning into our come at the time, thought retirement home. It was a weekend it was about a week before the announcement by the president in the rose garden, and i was asked if i would be interested. Of course, immediately without hesitation, with full support by susan who, by the way, with sitting right next to me when i got the call, you know, it was immediate yes, yes, i am honod humbled to do so, and, quite frankly, greatly privileged to coldly discovered with dr. Moncef slaoui who was justs the city earlier a remarkable leader and scientist. As i said earlier quickly, people who know me and ive been friends of mine can speculate why i was picked primarily probably to enable manufacturing, distribution, but it is also about the collective leadership and experiences of all the years i have served. And so i would tell you that my experiences have really contributed to what i have done. My instincts that ive developed over the years have enabled and supported decisionmaking, but in partnership with dr. Slaoui we have been able to really just put really numerous pieces together simultaneously, understanding really teaching each other. I have never ever worked with a greater collective group of professionals whether scientists, doctors, military persons, industry and really academic, thats why its so exciting to do what im doing and at the end of the day, i know that you know this but it is just a calling and this is about saving american lives and for me is a focused effort to do so and integrate collaborative effort and egos are checked at the door and we are working this together to this day that will bring america back to a healthy state. Thank you for that question and probably underestimated the impact if susan is listening in but i really appreciate her support if she is listening, thank you, sir. When it you go ahead with the questions. Thank you have been scrolling to the ones from the audience and some folks have questions that are very similar to the ones on my mind, doctor, i would like to ask you a couple of things that is really in the forefront not only of our listeners that the general public and some of the safety issues around here, one of the things that is gotten overlooked and you touched on in your remarks, what most people are used to in terms of vaccines that they got his children are flu vaccines is different now, we are very different technologies and some of these are new technologies that are being applied for the first time in Vaccine Development such as messenger rna, i would like impossible for you to address the concerns with the infection from a vaccine or Something Like that, whether those concerns are relative to the new vaccines, how is the safety profile . First of all thank you for the question and will probably make a couple points and im happy to elaborate further, i want to go back to my previous comments in terms of volunteers and in terms of Clinical Trial, i think most people understand but to stated clearly with every vaccine that has been administered as part of operation work speed it is done in the context of a Clinical Trial, what that starts with, somebody makes an individual decision and says im willing to sign up as part of the process we explained the risks and the potential benefits in detail but we also acknowledge that we dont know everything there is to know about the vaccines, it goes back to the spirit of volunteerism, we appreciate people willing to do that as part of developing the vaccines, what we also do for the willingness to volunteer, we monitoring them extremely closely to make sure theyre not having side effects and make sure were truly understanding the impact of the vaccines. When we say 30000 patients, what were talking about or 30000 volunteers, we are saying 15000 of the volunteers have received placebo but 15000 volunteers have received these vaccines and were watching them literally on a daily basis to say how are the vaccines going okay, are we seeing side effects from them or not, that is the first point that the safety standard and all of the information is package process and ultimately presented to the food and Drug Administration for an independent evaluation to make sure these vaccines are safe. The second point in terms of new technology and Vaccine Technology in general, as i previously mentioned angie mentioned that there are very traditional ways of making vaccines and weve also seen a lot of progress that are accelerating allowing us to make vaccines faster, one of the benefits that we think were going to see from this is that it may make the vaccine safer as well and what we seeing with the product that we chosen, not for covid19 but for other pathogens that these vaccines have been tested in Clinical Trials and have shown us that they are effective for other pathogens but also save so essentially for each of the vaccines in her portfolio and have uses Similar Technology for an ebola vaccine or Something Like that and we look at the detail safety profile of every person that received those vaccine, and the safety profiles have looked to be safe so far. Ultimately we are not only saying were looking at the vaccines in the short term for Clinical Trials but as part of the regulatory process, the food and Drug Administration is providing guidance in terms of how we will follow these people out in the long term, that like any other vaccine we are meeting the High Standard so the longterm safety will be followed according to regulati regulation. I think that gets the other concerns that weve heard expressed by people which of the whole process operation work speed is posting a long enough fastpaced, that implied the corners are being cut but it may not be safe et cetera, i think what is not fully appreciated as you mentioned, the technologies being used allow for faster mass production then has extorte hisy been the case for the vaccine, just because the nature of the technology there is a Better Safety profile and i think youve addressed two things in your comments about the speed, one they are taking steps in parallel instead of the sequence, the risk to that, we may be paying money for stuff that turns up from not work but better try five things and wait for one to fail then try another. And the other point, i want to drill down on that is a critical trials, it sounds like essentially to expedite the process that you all are vaccine candidates and sponsors are doing larger trials than they would normally at this stage, is that correct . Yes, sir we agree with all your points, if i could add a couple of points, we are not cutting corners on safety, we are not cutting corners on the quality of the manufactured product, those will be done to the highest standard and we are not cutting corners in terms of what would be expected from regulatory of food and Drug Administration which has the highest standard in the world for medical products, we are going to meet those standards, i think its an Important Message and i think we are practicing what we preach, one of the things that we would highlight is the food and Drug Administration has published guidelines and heres what were going to expect for covid19, the fda has had a Public Meeting last week where they had an open dialogue about heres how were going to evaluate the products and heres why. Weve also with the products in the earlier phases of Clinical Trials in the free Clinical Development that companies are publishing their results in peerreviewed journal, all of this is not only showing that we dont cut corners but i strongly feel this is been an incredible transparent process so people will have confidence in the vaccines that we are generating, my second point to answer the question, these are large Clinical Trials, these are Clinical Trials enrolling a lot of volunteers in a short period of time, these are Clinical Trials where our experts and professionals are working nights and weekends and as you would expect we are doing that to but are partners in the private sector that are running these Clinical Trials are working aroundtheclock to get the Clinical Trials up and running but its ultimately driven by those people who have said thousands of people are lining up at the door with the Clinical Trial site saying please i want to do my part in volunteer. If i ask one very interesting question i came up from one of our viewers that follows on this line, there is the probability or possibility that there will be more than one vaccine available at the same time for covid and the obvious question will people have a choice in how would they choose which one to take, i thought that was interesting question have you given thought to that . We have, not coincidentally we were in a meeting talking about this right before and i will say there will be some complexity but god i hope we have that problem, we went into this process doing the impossible with the thought that we would invest in six vaccines with the hopes that we would have one vaccine that makes it through all of the typical challenges of medical Product Development, we still have six that are on track, we are thrilled we made this much progress so far but we are working through our department of defense colleagues understand this very well, the contingency plan, and all aspects of operation work speed have thought about all the different scenarios and contingency plans. There are scenarios where we might have more than one vaccine that could be useful. The simple answer to your question, we are going to let the science drive that process in terms of which vaccines work best for which people. Meeting it is possible we may have equivalent efficacy and equivalent safety across the board, we could also be in a scenario where one of our vaccines works very well in elderly populations that are most vulnerable so we would then pivot our program so the vaccine that works best in elderly are given to elderly volunteers. A final point i will make, all of our vaccines in her portfolio are two dose vaccines which is everyone can appreciate as a lot of complexity, the vaccine for which we are enrolling as i mentioned in the Clinical Trial is a one dose vaccine, were thinking through contingency plans as well in situations if we have a one dose vaccine, what would be the use of that. Presumably the large study is doing 30000 in the phase three trial as opposed to 5000 as you mentioned earlier, that enables the companys, the sponsors and the fda to get a better handle on some of the issues like differences in age and race rebuilder demographic issue. Yes, sir. Im going to try to bundle a couple of questions because were getting a lot of good ones, i was hoping a lot of people have asked about the military role in terms of distribution of the vaccine and they also asked i heard we have an election coming up, what a change in administration how would that affect operation work speed. Thank you, real quickly to answer your first question correctly, the military is providing planning, we are helping with logistics of Augmentation Program support, we are Running Program management for the team, what were doing is enabling capability and capacity to the fight, there will not be a vision that some people have with army trucks driving to the street delivering vaccines, that is not one feasible or the right way to do it, this is the greatest country in the world and we know how to do this, commercial industry knows how to do it and thats how were going to do it, the second point to your question we have her head down and driving the sled and were going to execute our mission as directed. I see nothing that would cause us to stop doing what were doing no matter the results of the election, i would like to highlight again we talked briefly about the whole of america approach and i want everybody to visualize the brilliance of what were doing and this is not my vision or doctors vision but really others who had the foresight envision the brain and the collective team together, this team is partnering at the highest level of health and Human Services and the secretary of defense, we are a direct report to them we do not have to go through staffs incarnate time, we are pick up the phone and we have direct and immediate access to the senior secretaries. To everything that we are doing is from scratch, the whole process is built from the ground up scratch, there was no structure and execution, there was no strategy and execution, there was no Training Guidance or budget and execution and all of it had to be brought together, simultaneously as we have started our effort collectively, so we built the team across as i talked about hhs, department of defense industry, academia by those who we thought could contribute and those who would help us really make the stride necessary to achieve our goal by the end of the year, to that and we really had to check egos out the door, you had to come in and no matter what you were a part of before, you had to shoulder the burden of responsibility and execution, not just sitting at the end of the table to you had to have the right relationships to garner support in all that we were doing and three at the end of the day were all being held accountable to help moving the ball, were interested in theory of what could be we are every single day, all of us, we have received hundreds of emails from people with recommendations and some of them are very illuminating and helpful and there welcomed and were very appreciative that we receive them. On the other side of the spectrum we get a lot of conversation about everything that we are doing and how its not going to work and how is not the right way to do it, quite frankly, not very helpful, my thing is the a part of the team, help us become successful, understand this is never ever been done before and we have successfully, so far taken in process that normally takes between 5 10 years and built an extraordinary team, put it all together and successfully driving down the field, at the end of the day itll be a part of what were doing, come help us do a better but sitting on the sidelines is not helpful to what we are doing. Thank you very much, i have a lot of questions and i want to get through as many as possible, doctor, maybe this is for you, couple people asked does this everything you are in now change fundamentally how vaccines are developed in this country, how we move the goalpost permanently or is this just a thing or are we going to go back to 8 10 years Vaccine Development cycles and if i could piggyback on that, a couple people asked about the really cold temperatures that some of these vaccines may have to be stored at, can one of you talk to the challenges and solutions we have for that situation. Sure, id be happy to start, frankly i find it profoundly exciting to say imagine a world postpandemic where we can rapidly develop treatments, where we can rapidly develop vaccines, not only for the new threat that come up that we were not expecting but for all of the infections that plague us as a global community, i do hope that we can revolutionize Vaccine Development and i hope we can show people what is possible in terms of how we can achieve accelerated Product Development without compromising and making sure the vaccines are safe and effective, im glad you brought it up. , i saw an interesting question if i can jump in from one of our listeners asking about the estimated duration of protection that these vaccine candidates will be, that is one of the open questions, if it generates a response, how long does that response last, do you have anything you can share with us or is that something we will get will beget the Clinical Trial results. Were gonna have to wait until the Clinical Trial results but the intention, this is why the people that are vaccinated in the Clinical Trial, our intention is to follow for up to two years so we can get a better idea on the critically important question of duration of protection. What we are also doing, again we are informed by great scientists and the National Institute of health and Academic Collaboration that we are watching, we dont understand the duration of protection from Coronavirus Infection itself, can you get coronavirus again and there is a lot of recent publications that are coming out getting a better characterization of the response to Coronavirus Infection, all of that is feeding into our Vaccine Program so we are understanding that duration of protection and ultimately we will design the trial and the medical research to answer it. Let me pick up on a question that a publi a couple of peoplee asked im sure you have a word for it but its vaccine hesitancy, some people reluctant in the best of times to get a vaccine and this might be a bit more than that, what are your plans Going Forward to attack this problem with the fear and reluctance of people might have to get these vaccines. We acknowledge, appreciate and we have been very thoughtf thoughtful, that is a much bigger issue than operation warp speed but certainly will impact what we do, from my standpoint and alternate over for further comment but from my standpoint what we said the Product Development, this is why we do not cut corners, this is why we make sure we maintain the highest ethical quality and regulatory standard and that we are transparent throughout the process so we can create a sense of confidence that what we know is being communicated publicly so people can make the decision about these vaccines but again where you can help us, everybody on the phone conveying the message that were doing everything we can to assess the vaccines for their safety and efficacy, hopefully that will inspire confidence that once we show the vaccines meet the regulatory standard that people will be willing to get the shot. I was going to add that i am 100 confidence that we have executed to make sure that the vaccines are safe and in the development i feel confident they will demonstrate at the qc against the virus. In that light i also have 100 confidence as doctor halfbreed alluded to in what i think is the Gold Standard for the world, that is our fda approach to determining whether or not the vaccine is safe and effective. And we will make sure that we will follow the science to that in, we will not distribute vaccines that are not determined safe and effective and you can take my personal word for tha that was just my word i dont want to speak for others, what i think about every day when i come into work, and just to personalize it for me i think about my 84yearold mother and her husband, i think about my three granddaughters and extend all the way through my family and friends and everybody ive ever served with over the last 39 years, thats how i extend myself personally to this effort and nobody in this organization, this task forces going to allow a vaccine to go out to the American People that is not safe and effective, it would just be shameful if we get a vaccine out to the American People and people do not take it because there is doubt or concern, we are working hard, diligently to increase confidence in the vaccine, it will be everybodys individual rights to determine whether or not they want the vaccine but what we stand behind is the safety and efficacy of a vaccine that will be delivered to the American People. Great, one last question and we may go over a bit so i understand with people who have to leave, has to do with the actual distribution of the vaccine, who decides between the elderly, the first responders, all those type of things that way to those lines between the federal government operation warp speed in the states in the territories, can you talk about that briefly. All make some initial comments on the Product Development on the scientific sign and handed over in terms of distribution, we have designed our Clinical Trials to really assess if the vaccine will protect those most honorable, the broad categories are the elderly or people over 65 and also people with other types of medical condition, we are ensuring a large percentage of our Clinical Trials are enrolling of volunteers so we can understand how effective it is and i hope it will be, the answer to your question ultimately is the first step is to understand how the vaccines perform, again we emphasize the science drives the process, once we understand that it will go into a prioritization process and all that general, on that. As he did a great job talking, the science will drive it and it will be the safety by the fda, the cdc will play a role in helping to define based on the fda findings, the priority in recommendation of how the vaccines and be distributed and then approved by the health and Human Services secretary accordingly, at that time we will distribute vaccines accordingly to all of america simultaneously, we will make sure there is equitable distribution in accordance with the priority and then the stat states, they own the final distribution and administration down to individual arms so really a collective Team Approach to the effort. My understanding they have submitted plans to hhs and cdc on the local distributions, is that correct. They did a remarkable job and they also spent about five or seven days reviewing them and providing synopsis and we returned them yesterday, all weakened teams were working on them and return them yesterday so we continually improve our effort to make sure its done the right way. If we can get secretary as art to facilitate those more broadly, that would be helpful. We have run to the end of her time, i personally go another hour listening to this, i want to think for participating today in more general terms for your great work on this, i know you are working really long hours and its not going unnoticed by americans, thank you so much for joining us today on behalf of ed and nine, thank you for your time today and i wish everybody on this call a great day, thank you. Thank you. Today the candidates running for indiana governor incumbent republican governor, democrat and libertarian donald rainwater take part in the televised debate sponsored by the indiana debate commission, live coverage begins at 7 00 p. M. Eastern on cspan2. Seven days left until election day on november 3 when Voters Decide who will control congress and occupy the white house next year, stay with cspan, watch camping trip to 20 coverage every day on cspan stream or ondemand at cspan. Org or listen on the cspan radio not your place for an unfiltered view of politics. The competition on the part of the student him competition, middle and high school students, be the start of the National Conversation by making a five to six minute documentary exploring the issues that you want the president and congress to address in 2021, be bold with your documentary, show supporting and opposing point of view and include cspan videos, be a winner, 100,000 in total cash prizes, including the grand prize of 5000, the deadline is generally 20th, 2021, be informed, you will find competition rules and tips and more information on how to get started on our website, studentcam. Org