Key to our success. Its not our plan that needs to be implemented perfectly. Its the governors plans that we want to enable, that we want to empower, that we want to make sure that we can execute according to their priorities and guidance. That i know their space. They know their people. They are being informed by highly professional medical personnel that know their people and their states. Our position is to enable them. So it is this trifecta, the cdc, commercial industry and the governors and their states that will make us successful at the end of the day. Trust me, its about collaboration, its about unity of effort. Its not about command and control. This is what the operation has been able to synchronize and integrate. So as said earlier, right . What is our goal . Our goal is upon eua, emergency use authorization, which will be determined by the fda. We will start moving vaccines within 24 hours. We will move them throughout the entire United States of america. 50 states, eight territories, six major cities. Five federal agencies. We know, right, based on the Allocations Available from Pfizer Vaccine and our allocation process was by pro rata to the population of each state, territory or city above the age of 18 to ensure fair and equitable distribution of vaccine every day. We know that for Pfizer Vaccine based on our allocation, we know exactly as of last friday where the states want their vaccine distributed to. We know the locations, our address. We know the populations based on the amounts that they want at each location. We know this as a fact. Were already sharing this information with industry, which ill talk about in a minute, what theyre going to do with it so they can plan package and prepare and distribute. This week were working on the Moderna Vaccine initial allocations with the states. By this friday we will have all the locations for the moderna Vaccine Allocation from the states. Well know where they want it and how much they want it. So within a oneweek period, weve been able to accumulate, process and inform and collaborate where the vaccine is going to. Key to our success. So now we have eua, we have the information we need, where its going, how much is going. So how is it going . First, the Pfizer Vaccine is depicted up front half of the chart. Their goal is to deliver vaccine to the right side of the chart on all of those places and locations we want it to go to. Pfizer vaccine pfizer has chosen to do their own delivery of vaccine, right . In collaboration with us, our priorities to distribution capabilities. Right . Fed ex and ups. Right . They will distribute the fed ex and ups and fed ex and ups will break down the vaccine by location and then distribute it to the final locations accordingly. The Moderna Vaccine is going a little bit differently. Moderna chose to have a distributor come in and help them mckesson will take responsibility for that. Theyre going to break down the vaccine. They will repackage it, then they will distribute it through fed ex and ups down through the final Administration Sites as directed by the governors. At the end of the day, whether its pfizer or moderna, our capability and capacity is something that we know how to do and we know how to track and how to implement it and how to make sure that the vaccine is delivered, delivered safely, it is delivered to ensure the stability of the vaccine and it is delivered securely to the locations that we said. Right . This is why we put this all together. It will be a herculean task. But im confident, as i said, the planning by the cdc, the collaboration by our partners, mckesson, fed ex, ups, cvs, walgreens, that we can execute the vaccine efficiently and more importantly effectively. As we start to deliver the vaccine, we will be able to track every single vaccine from start to finish. We have worked in great collaboration with commercial industry. We have developed a capacity or capability to track every vaccine. We will see from point a to point b. We will understand how the vaccine is being administered in arms and we will continue to flow vaccine to support the use at the Administration Sites. The key is flow of available vaccine. Were not waiting for a montly cycle of delivery of vaccine. Every day, every week that vaccine become as available, allocations will be provided to the states and we will start and we will execute a predictable and consistent cadence of vaccine delivery. We will do that by providing allocations to the states. States will tell us where they want the vaccines to go and we will deliver the vaccines in accordance to the process that i told you. What is the greatness of this . It is about making sure that we get the initial doses out, following eua within 24 hours and then providing a steady cadence of vaccine so that planners can plan and then people who are going to have to administer understand the timing of administration where we can notify persons to come get shots and be available. Its the flow were trying to create that will determine our success. Im very excited about this. Im very excited about the amount of work that has gone into this. Somebody said to me the other day, i heard theres eua coming about. Are you going to start planning . I said start planning . We literally started planning as dr. Slaoui talked about seven months ago. It was in parallel that we executed this. We assumed success so that we could get ahead of the problem. Because of the great efforts by the cdc, the collaboration of commercial industry and the states herculean effort to plan for people to receive shots that were going to be successful. So with that said, i will tell you, i am 100 confident that we will be able to implement this. With our collaboration of the trifecta there, we will be successful, and we will start to have shots in arms within 96 hours of eua. Thats what i believe with all of my heart. And i am counting on it because i for one have told my mother, get the vaccine. I told my sons, get the vaccine. Thats how confident i am in this. So i ask for you as dr. Slaoui said at the end, right . All of us, the American People, we can beat this only together. Right . We can do this if we do it together. Right . Be informed. Right . Dont be led. Understand, do your research, hold yourself accountable to hearing both sides of the story and make an individual decision that is best for yourself and your family and your community. Right . If we do that, we will be successful and we will defeat, right, the enemy, which is covid. So with that said, thank you, everybody, for your time. Its a real pleasure. [applause] bill this is really great stuff here. Were watching american history. Were watching medical history. Operation warp speed. Taking a bit of a victory lap and for good reason. Im bill hemmer. Good afternoon. Well continue in this hearing for some time. We want to give our experts a chance to react. Gentlemen, hello to you. Welcome. Doctor, i know you have a time crunch here. I think what the general said there is amazing. He said where is the end zone . The end zone is shots in the arm. Its happening in london today. Its going to happen here soon. What do you take away from the first hour, doc . Yeah, bill, thanks for having me on. I cant help but feel really optimistic about what weve heard. Look, theres a lot of planning thats gone into it. Id love it if the first shots are going in in 24 to 48 hours after third. The Biggest Issue is how many shots can we get, how many vaccines can we pull together. How quickly my guess it will take a few months till it gets out. This is progress. Dr. Mccarry, what is your take . The best news is we heard that the fda has found no serious adverse events. There were eight infections in the vaccine arm and 162 in the placebo arm. That is all the information we need. Quite frankly, we should have been doing this a few weeks ago. This was data that was straightforward. Its amazing bill we werent we, doc . We talked about it a few days ago. Why didnt we . Well, i think theres a massive bureaucracy over there. Its the same reason your income tax form take a long time to fill out. Could be streamlined. If the fda would have reduced the time in half forget about a 24hour emergency meeting, which they could have done to review this straightforward data. If they would have cut the time in half, that would have saved about 17,000 lives. 34,000 americans will have died during the time that the fda is reviewing the pfizer data after it was submitted. We could have done better. Woo were in a good spot. Bill the fda looks at the vaccine trial results and 34,000 died. Its a heavy thought. Doctor, do you agree with his position that the fda, despite the speed could have gone faster . Im a big fan of the doctor. Im going to disagree vehemently here. Heres the issue, bill. The bottom line is we could have just taken the data that pfizer presented and said, okay, thats good enough. The fda has a long track record of doing things the right way. Theyve had 150 people working day and night reviewing this data since pfizer submitted it. I think i know the delay is not ideal, but the bottom line is its worth getting it right. Imagine if we had missed adverse events or rubber stamped this and found out bad things were happening, that would have been a disaster. I appreciate the delay, cost lives but getting it right is more important. Bill go ahead, doctor. There were no serious adverse events in any of the patients. So the 27day hunt for an adverse event yielded nothing. That could have been done quicker. I agree. We shouldnt cut any corners but this could have been done quicker. My clinical background is that of a surgeon. We have to make life and death decisions all the time. When you dont make a decision, 2,000 americans are dying a day. 3s the point. Bill thanks to both of you. Were going to get inside the hearing. An ebb and flow of good news and bad news going back to last february. Certainly is a good news day. Doctors, thanks so much. Were not listening to adam boller from the International Finance corporation. This is how the fda evaluates the vaccine candidates. To the white house we go in washington. What that means by doing things parallel in a parallel manner, corners were not cut here. This is a vaccine that has gone through these vaccines are going through the large kinds of trials that we would expect from prophylactic vaccines that will be given to a large number of people. The average Vaccine Development program for the kind of prophylactic that were talking about is 21,750 people enrolled. So this these programs went from 30,000 to 45,000, 44,000 individuals enrolled. That is a pretty nice size program. So that is giving us kind of the Gold Standard types of Clinical Trial program that we like to see for preventative vaccines. Thank you, dr. Marks. One question that is circling and dr. Slaoui just talked about it is whether americans should take this vaccine. So let me ask that question to you. Why should Americans Trust these vaccines . So the reason why im sitting here today and the reason why were going through the process were going through at fda is so that americans can trust a vaccine theyre going to receive. The fda is known around the world for its regulatory rigor. Were one of the only regulators in the world where we dont just take the data handed to it from companies and look at it. We take the data listings, the raw data and do analyses our serves on that. Its a group of over 150 people working right now at fda to go through and do these type of analyses to make sure that the vaccine is what it says it is. To make sure that we fully under the side effect profile, to understand sometimes we learn things that the manufacturers didnt even know about the vaccines by doing our analyses. So by doing that hard work, the folks are making sure that weve when it comes through this process, were going to have a vaccine that has efficacy that we can trust, safety that we can trust and quality to trust, which is what americans deserve because all the people working at fda right now are thinking about this vaccine as if its one that they want to take, they want to have their families take and then have our extended family in the United States take. This is really important. Were only going to get there if we do this together, by taking vaccines together. This is a time where we have to rebuild our trust in vaccines. We hope by going to a Advisory Committee and the public view, where people will see the data being be it forth, a discussion against monk academic experts of the safety, effectiveness and the quality of these vaccines that people will see, nothing is being hidden, that these are vaccines that when we say at fda theyre safe and effective, it means weve done our best job to make sure theyre safe and effective for all of us to roll up our sleeves and take. Thank you. Could you expand a little bit on the Clinical Trial process . The size, the scope. Give me a little sense of that. So these Clinical Trials that involve the randomization, so flipping a coin and putting one to one person getting a placebo or inactive product versus the active vaccine. Where we have 15,000 people in each arm to compare them means that we have a very large size trial, which not only lets us get to the efficacy quicker as dr. Slaoui noted but give us a very nice size safety database. Although normally we like to have longer follow up of individuals perhaps than well have right now, were able to make up for that by following the people who are in the Clinical Trials for longer periods of time and by the fact that over the past ten years in the United States, we developed a very robust safety Surveillance System which uses large databases during hundreds of millions of live to look at adverse events to make sure there are not problems coming up after the vaccines are given to people. We wouldnt let them out there in the first place if we thought that there was any significant chance of that. But we are going to make sure by monitoring them that there are things that emerge as theyre used. What happens next . I know obviously the fda will go through their process. A lot of people are expecting we hope for authorization. So assuming that that happens, assuming that you issued the eua, what happens next . So after an emergency use authorization is granted, we will several things will happen. But the Advisory Committee will make further recommendations about use of the vaccine. The vaccine will get in to the generals hands and well get it out there and activate our safive Surveillance System. There will be in the coming months additional trials that will be done on these vaccines. Theres populations that we still dont have information on that we have to get information. Children, pregnant women among them, that will get more data on these vaccines so well be able to ultimately hopefully by late spring start to get to the entire population and get to children so we can stop the entire covid cycle. Once it gets to the generals hands what . Thats it. One final question for you, dr. Marks. Expand a little bit on how important it is for every american to get this vaccine or not . Feel free to say. I think its really critical here to understand that what were doing at fda is trying to make sure that people have the confidence to use vaccines. Vaccines have been an incredible Public Health advance. Our agency has been regulating vaccines for over 100 years. Since before the center for buy logics predated the food and drug administration. It was established in 1902 for anyone that wants a history lesson. Weve been doing this for a while. The first or second bioligic was for a small pox vaccine. We have a good sense of what safety looks like for a vaccine. Weve seen what vaccines can do. Eliminated small pox. Polio is something that nobody sees anymore in the United States because its gone pretty much. Even measles, we dont see because as long as we keep getting our children vaccinated, we dont have measles outbreaks in the United States. So its a huge transformation from vaccines. We would not allow vaccines to go out there if they werent safe and effective. When we see safety signals, we deal with them. So its critical here that we all trust in the outcome of this process because we all need to bring this crisis to an end together and getting vaccinated is kind of a first step there. You know, what we have right now is we can wear masks, we can cash our hands and stay social disstanced. With a vaccine, we can have it eradicated. That will only happen if a large fraction of eligible people take the vaccine. Thank you, dr. Marks. Washington can be a difficult town. But you and your team and the group here show this is not a partisan effort. Its an american effort. As an american, i want to really say how much i appreciate all your work and your teams work. Thanks very much. I have to say, i have an Incredible Team of diverse individuals that are so committed to this, this they have worked tirelessly and they will continue to work tirelessly with these vaccines and additional vaccines till we have what we need to beat covid19. Thank you. [applause] bill a little more from dr. Peter marks from the fda. Had the conversation there that q a went down to the white house. The britts took the data about a week ago and giving vaccinations as we speak. The first woman, age 80. She was given a vaccination earlier today and patient number 1. Back with the doctors. We wait for the white house to reset for the next segment, which is dr. Admiral girrar. He will talk about how the vaccine will be distributed. On that point about distribution, why is it that pfizer were do it on its own and moderna will lean on the government to help them 0 it . Why would there be a different when it comes to distribution . Why wouldnt it be uniform . Yeah, so pfizer has not taken money through operation warp speed. They made a decision early on, the ceo, that they were going to do this on their own. They werent going to take that money. It gives them more freedom. My sense is they will coordinate. Theyre not going to go rogue