Briefing with officials on operation warp speed to give an update on the status of a coronavirus vexing. They discussed how a vaccine would be distributed across the authorizede one is for emergency use. This is one hour. Hello, everyone, and thank you so much for joining our weekly operation of warp speed briefing. While we continue to face concerning epidemiological trends across much of the country, we also continue receiving good news through operation warp speed. With modernas announcement on monday, two companies have now filed eua applications with the fda. Out of the three companies that have showed promising data for efficacy in phase 3 trials. On top of that, more owssupported candidates are well on their way in that final phase of Clinical Trials. The fda has now scheduled a meeting of its vaccine Requirement Committee to review the Moderna Vaccine on the 17th following their meeting of the Pfizer Vaccine on december 10th. We also learned this morning that the United Kingdom has granted authorization to the Pfizer Vaccine. While the fda completes its review, the approval of another independent regulatory body should give americans additional confidence in the quality of such a vaccine. If all goes well, as general perna will lay out, that means we can make our first shipments of vaccine to states this month, and we are on track to be able to ship enough vaccine for 20 million americans before the end of the year. Of course, were all eager to have enough supply to vaccinate every american who wants it. Because of operation warp speed, we expect it to be at that point in the spring. Having substantial quantities of a safe and effective vaccine thats been authorized by the fda before the end of the year is a remarkable achievement and it will start saving lives very soon. As all of you likely know, yesterday the cdc held its meeting on Advisory Committee recommendation practices which is recommendations to our leadership on how vaccines can be equitably distributed. These recommendations will be used by states to develop the priority system for their own citizens. States have different circumstances and are in different epidemiological situations, and state leaders are in the best position to take our general National Recommendations and translate them into more precise guidance for their state and its conditions. As we approach the vaccine rollout, were also continuing to expand access to treatments for covid19. As of this week, weve distributed more than 157,000 patient courses of two authorized antibody products across the United States and allocated a total of 205,000 courses for delivery to states. More than 3,000 sites are currently signed up to offer these treatments. Weve also launched a Pilot Program that will explore how to reach vulnerable populations with these treatments and offer the treatments in even more convenient locations. As we mentioned, americans need to know that this treatment is a possible option for patients who are at high risk for severe covid19 but who have not been hospitalized. That includes all americans over the age of 65. Thats the definition were using, in this case, for risk of severe covid19. Receiving this treatment if youre in that category could help keep you out of the hospital, potentially helping to save your life. So we want to encourage the news media and all americans to spread the word about the availability of covid19 treatments and want to encourage americans to Start Playing the role that theyll have an eventual vaccine, too. Vaccines will only bring this pandemic to an end if enough americans choose to take these vaccines. We now have highly promising efficacy data that i believe Many Americans are encouraged by and excited about. But i want to encourage americans to get prepared and to get educated now. Visit the cdcs website to find out more about the vaccines were developing and the process theyve gone through. If you have questions now or have questions further down the road, talk to your Health Care Provider about the importance that safe and effective vaccines have to our own health and the health of our communities. These vaccine products will be assessed with the same rigor that americans can expect when it comes to any other vaccine or drug that is reviewed by the fda. As each one of us here has said, were excited to take this vaccine, and we will encourage our family and friends to do so, too, as appropriate. Now, i apologize that i wont be able to stay throughout todays q a because of another media engagement, but i will be back next week for the full hour. Before i close, i would like to just make a plea to individuals who have had covid19 and recovered. If youre within three months since recovery from covid19, we need you to donate plasma. Over a quarter million courses of convalescent plasma have been used on your fellow americans to help prevent severe consequences from covid19. We unfortunately have so many individuals who have gotten covid19 and have recovered now, fortunately, but we need donations. Please contact your local american red cross, your local american blood bank, or go to coronavirus. Gov for more information about how you can volunteer to be a donor and give the gift of life. With that i will turn things over to the extremely capable hands of our leaders, dr. Slowi and gus perna who will lead the rest of this briefing and i will see you next week. Thank you very much. Dr. Slowi . Just a few points to add to what the secretary has provided. Very, very rich week in new data information. So on the Moderna Vaccine side of things, the final analysis has now been completed with 94. 1 efficacy against moderate and severe disease. Importantly there were 30 cases of severe disease in the trial, so 100 efficacy. There were 105,000 and some elderly people with the age over 65 and efficacy of the population against moderate disease was 87. 1 and efficacy against severe disease was also at 100 since there were no cases in the vaccine group. I think those are very important data to keep in mind. Its exceptionally good data, and, in fact, remarkably similar to the data that you have already seen coming from with the Pfizer Vaccine. Obviously, as the secretary said, the fact that an external Regulatory Agency of the highest caliber and standards equivalent to those of the fda, the uk, mhra, have approved the Pfizer Vaccine. Of course, they have not involved in any of the politicization that surrounded the development of this vaccine, and i hope this will be other evidence for the American Population that the data with these vaccines are clear, are transparent and demonstrate that they are effective and safe for use in the general population. As the secretary said, vaccines are useless if they are not used to vaccinate people. I think also really great progress with two other vaccines in the pipeline. The Johnson Johnson vaccine, which is a human virus 26 vector has now recruited a little bit more than 28,000 subjects in the phase 3 trial. Now, the breakthrough that we hope with this vaccine is that its a oneshot vaccine with very fast efficacy achieved and 100 compliance, so to speak, since several of you who get one shot get the full vaccination. It will be very important, by the way, for all americans who get the moderna or the Pfizer Vaccine to have their first vaccine dose and then come back three or four weeks later to get their second vaccine dose to complete the immunization schedule. The next vaccine in the line is the astrazeneca chimpanzee virus live vector vaccine. The phase 3 trial was conducted here in the u. S. In the operation warp speed oversight, so its a different trial than the u. K. Brazil trials that have been communicated about last week. Its progressing very well. We have about 16,000 subjects recruited in the trial. Both the Johnson Johnson and astrazeneca trial are likely to complete their number of cases accruing somewhere in very late december and middle of january. Unfortunately, the pandemic is extremely active and there is a lot of transmission in the population. In closing on the side of vaccine, i would just like to remind you that fortunately the investments we have made in scaling up and starting to stockpile manufacturing of the vaccines allow us to feel confident that we will be able to distribute 20 million enough vaccine to immunize 20 Million People in the u. S. In december, 14 million doses. Then 30 Million People, 60 million doses in january, and 50 Million People or 100 million doses in march. So between december, middecember sorry, in february. In the end of february, we will have potentially immunized 100 Million People which is really more or less the size of the significant atrisk population. The elderly, the health care workers, the first line workers, people with comorbidity. Of course, we will answer your questions later on and pass you on to dr. Perna. Thank you, dr. Slaoui. I want to talk about three things. Allocation update, our distribution and support of the state plans, our ability to empower them, to execute their plans, and then third, just to reinforce the challenge my word to secretary azars comments at the end about learning about vaccines. So, you know, first reference, allocations. We have provided the 64 jurisdictions, which as a reminder is 50 states, eight territories and six mega cities as well as five federal agencies with their allocations of the vaccines that are going to be available in the month of december. What weve done is, we believe for planning purposes only we had to pick a day, and ive coined the phrase snap the chalk line so we could plan on actual doses that would be available. So, for example, a week and a half ago, around 20 november through tiberius, we identified the four areas of the 4 million doses that will be available. A week later on 27 november, we provided the 64 jurisdictions and five federal agencies, their allocations for the Moderna Vaccine at 12. 5 million doses that will be available. Again, we are planning to be ready when eua is approved. It is not about getting in front of eua, its just making sure that we have everything locked so when eua decision comes, distribution to the American People becomes immediate within 24 hours. Thats our goal, thats what were striving for, and thats what were working to. You cant execute if you dont have a plan, and thats what our emphasis is as we work through all that process. We are going to send half the doses based on allocations to the jurisdictions and agencies because it is a twodose regimen, as dr. Slaoui just talked about, so half the allocation will be sent out, and then 21 days later for pfizer and 28 days later for moderna, we send out the second half of allocations. Two reasons, one, to ensure that we dont overadminister and that we have the second dose on hand, and second reason is to make sure that we dont overwhelm limited storage capability and capacity at the state level. We want to augment their plans, enable their plans, not constrain them from the greatest distribution capability that they have. We utilize a tiberius platform that we developed, which is the capability that takes in all the informative data from the states, hospitals, Doctors Offices, pharmacies only on the specification of vaccine as it is delivered and vaccine as it is administered so that we can maintain the flow of vaccine to the American People. As ive talked about, our goal is to distribute within 24 hours after eua, and the first pushes, then we want to maintain a cadence, a deliberate, planned, coordinated cadence of delivery of vaccine as it becomes available. The only way you can do that is if you see yourselves, and we have to see ourselves from point of administration all the way back to point of fill finish. And in doing so, we can coordinate, collaborate, plan together the distribution of vaccines down to the states. We have requested that the states lock in their micro plans for final distribution of both vaccines, so, for example, this week weve asked the states in total jurisdictions to have their micro plans in tiberius by the end of the week or for december. This way we can ensure that we understand all the places where they want the vaccine delivered and at what quantities they want the vaccine delivered, and then we can coordinate with pfizer to ensure those boxes are prepared and ready to be distributed upon eua. Addresses in the system, coordination with mckesson, the master distributor through fedex, ups and down to the Administration Sites. Really a key effort by everybody. Weve asked for the states and jurisdictions that have their micro plans ready for the Moderna Vaccine by the 11th of december, which allows them to do the same planning, and in theory, what happens is the vaccine comes in to where they want, it enables their plan for immediate administration of the vaccine to the priorities that their governor establishes at each state. Heres the key. The states know their people, their populations the best. And as they follow through with eventual eua guidance and the asip guidance that was put out yesterday, then you have leaders taking responsibility and directing a priority of vaccine into administration or shots in arms. Our responsibility is to enable their plan, to empower their plan, and thats why weve asked for the micro planning and the detailed work to happen accordingly. After the initial pushes go out for pfizer and moderna, then every week based on the availability of vaccine as dr. Slaoui, 40 million doses in september a december, then january, february, march, we are going to push allocations as vaccine becomes available. We are not waiting for cluster vaccine to be available and then push. We want to have this rheumatic, cadenced delivery of vaccine so the states can best manage it to the priorities as they developed it. We envisualize each week additional vaccines getting out and eventually we just continue to build on the amount of people that get vaccinated and, hence, on our way to ending this pandemic. Jurisdictions and the governors, quite frankly, will decide where they want it to go at the end of the day and were enabling it to that end. I would just reinforce here, allocations made, jurisdictions planning. Were trying to enable them to work through their priorities to best take care of the people of their jurisdictions accordingly. Second, id like to talk to you about how we are working to empower the states and make sure that they are well informed of all the processes we have available. I want to commend the cdc for the remarkable work that they are doing. These great leaders, these very, very talented professionals, well trained, experts in this field of distribution have really set up an elaborate coordination and collaboration effort with the states. They run daily, weekly meetings. They work through detailed execution of plans. They make recommendations on how to best facilitize and operationalize the distribution, and then they work on ways to enable the Distribution Plans. Well done by the cdc and im really proud to be a part of the collaboration with them. Second, we worked a very elaborate update in talking to the governors, either through hhs or up through Vice President pences sessions with them, but also through individual phone calls to the governors, to their Health Coordinators at the Senior Leadership level to make sure were answering questions in a timely manner, Getting Solutions to their problems. Again, we want to enable and empower the jurisdictions to execute their plans. That is our sole goal, our responsibility to do, and weve worked extremely hard. Two things ive coached people on over communication. We want to add that to our execution, and second, youve got to do the virtual circulation, right . We have to see what the governors and their staffs are seeing so we can best enable them. Clearly one of their concerns theyre working through is how to do nursing homes, longterm health care facilities, right, and the cdc and ows collaborated, really worked a very extensive plan in collaboration with cvs, walgreens and other private pharmacies to enable state governor plans on getting to those facilities. How do we get it out to them, how do we make sure were there to administer to them, and i am incredibly confident that these private Public Partnerships are ready to execute based on the governors priorities and plans to do so. And i am excited to watch that get operationalized. The last thing ill leave you with in touch with secretary azars comments and reinforcing dr. Slaouis comments on the potential of the efficacy of the vaccine, as we go forward, the vaccine is only as good as it is being administered to the American People. I just ask everybody to really educate yourself, right, figure out what you want to do as an individual, but be informed in your process. Dont allow one headline to determine what youre going to do. There is so much available information, and i just encourage everybody as an individual, a community and, of course, as a part of our great nation to really inform yourself and then make the decision that is best for you and your family. And so with that, dr. Slaoui, i think we can take questions. Thank you, operator. We can open it up to questions now, and a friendly reminder to our new friends that when asking a question, please state your name and publication and please keep your question as short as possible so we can get to as many questions as we can in the time we ever. Ill turn it over to an operator. Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star 1. Please unmute your phone and report your first and last name as well as your organization clearly when prompted. To withdraw your question, you may press star 2. Once again at this time, if you would like to ask a question, please press star 1. And our first question is from meg tirrell. If you wouldnt mind stating your organization, the line is open. Reporter thank you, rick. Meg tirrell with cnbc. Dr. Slaoui, i wonder if you could go back to those allocation numbers per month . I want to make sure we got it right. 40 million doses in december, 60 million in january . With only half the doses being sent out and the second half being followed up to ensure proper storage, what is the right way for us to talk about the number of people who will get their first shot with these doses . You know, in the first 6. 4 million, is that 6. 4 Million People getting their first shots . We often decide by two and say its enough for 2. 3 Million People. What is the right terminology for us to be using . Thank you, meg, for the question. I used the number of people to be vaccinated with a complete dose of vaccine, so two shots. 20 million in december, 30 million in january, 50 million in february, and thats with the pfizer and Moderna Vaccine. There is a chance that we may have more Vaccine Doses Available in february, particularly with the unsen vaccine if it gets emergency approved. So its possible with the number of cases that are accruing that that phase 3 trial completes its efficacy during the month of january. There could be a scenario we could have a little bit more with a oneshot vaccine. With that vaccine, it equals one person immunized. My recommendation is to use the number of people immunized. I think its more real to people. Our next question is from john collins with science magazine. Your line is open. Reporter hi. Dr. Slaoui and secretary azar praised the vision by the hia to pfizer, but many european leaders have criticized it as being hasty, and our own fda process is more precise and slower. I wonder if you want to clarify things that others are heavily criticizing in europe. We dont know exactly how the process has taken place. As you know, we stay totally away from the regulatory process, whether with the fda or with others. What we understand is that there have been instances where different parts of the file to be authorized have been submitted at different time points. I would speculate that pfizer and moderna parts have been filed a long time ago, and potentially the review has focused on the clinical site, the rest of it having been done earlier. But, frankly, i cannot comment. What i would agree with you completely is we know the fda process is a completely transparent process with independent experts commenting and asking questions and recommending or advising the agency. And we will imminently be going through it. I know personally from my experience in my previous life that the mhra is an extremely high grade agency. In fact, within the eua before they left it, they were certainly the scientific engine, the u. K. And the german part of the agency. Thank you. Our next question is from zachary brennan. Please state your organization, if you may. Your line is open. Reporter thanks for taking my questions. Zach from politico. General perna mentioned earlier that about 21 million jurisdictions still havent signed on to these data user agreements. What will happen with those jurisdictions if they ultimately dont sign on to those . And can you talk about why certain states are saying the vaccine allocations are a lot smaller than what they originally had thought . Yes. So first question, were down to 17. We are really getting to the last dot the i, cross the t, and i feel very confident that all the jurisdictions will have their data use agreements in and everything will be all right. To your second question, what were doing is instead of waiting until the end of december where we know well have a cumulative amount of vaccine, as dr. Slaoui mentioned and i reinforced at 40 million doses, what were doing is at the time we speculate uea is going to occur, the doses is 60 million for pfizer and 25 million for moderna. Thats what we based the allocations on. That push will go out based on the allocations, but every day that goes by after the initial push, additional vaccines come off the shelf because theyve been certified and approved for distribution and administration. Hence, what i talked about, the continuous cadence of delivery of vaccine going out to the American People. So its not a one and done, its an initial push and then a continuous, cadenced flow of vaccine for planning and coordination and execution. Thank you. Our next question is Stephanie Epps with abc news. Your line is open. Reporter thank you. I wanted to follow up on that with general perna. When youre talking about the continual cadence of delivery, how will the amount in those deliveries be allocated, and is it correct to say that each subsequent delivery would be followed with the same amount 21 or 23 days later . What were doing is through tiberius, the program that we established which is located at each of the jurisdictions, were establishing the available doses of vaccine to each state, and so they get to see that. The tiberius allows them to see the allocation, allows them to go through a planning process of where they would like to have the vaccine to go to manipulated so that they can see impact of the doses going to those locations, and then once finally approved, they hit send and that is how we distribute. So, quick answer to your question is through tiberius, open and transparent with each jurisdiction as allocations become available. And then the second part of your question, i apologize, i dont remember it. Can anybody help me on that one . I cant remember. It was the allocation in the states, how do you allocate those to the states . I apologize. Thank you. So the second part of the question was, are we going to hold the second dose for every distribution as we go forward in the cadence, and the answer is yes. Our responsibility is to make sure that we have both doses in hand before we send the first dose out. That way were always confident that the second dose will be available for everybody as they get administered their shots. Over. Thank you. Next question . Our next question is from steve housen with biocentury. The line is open. Reporter i wanted to ask if there are any systems in place for tracking outcomes for people who are vaccinated. Are there any reg streistries o other systems for determining what the outcomes are on an out going basis . Yes. The fda and the cdc are working very closely together to put together a very active vigilance and Surveillance System using very large databases currently in use and integrating all the data from those databases with potentially frequencies of assessment of events as frequently as every other day, which, frankly, gets even closer than how it happens in a Clinical Trial. And that the covered population will be very large and include large elderly populations, large varelated population and global population through various insurance so i think a very extensive plan. Next question. Our next question is from kevin brown with fox news. Your line is open. Hi. Good afternoon. Evan brown with fox news. If both gentlemen could once again talk about the whatever push is being done from a messaging standpoint to encourage as many people to get vaccinated, to quell their fears and really inspire them to take this action. And on the back end of that, how do people know how will people be able to know, were talking about general population now, when they would be able to get a vaccine, either at their Doctors Office or corner drugstore . I think it is it is every experts frankly duty today as we get more and more exposed to the data, which will become totally public at a time of fda review, to look into that data, to put aside their preset opinions, and anchor their comments into the data and the science. I really believe that through that process, thousands of experts are able to look into this data and comment on it and talk about it to the people that they interact with, because i think what i say is for everybody to keep lets keep our ears open and our mind receptive to the information that the factual information on the performance of the vaccine, both its safety and its efficacy. And then make our judgment whether we would use it or not. The experts across the country should take accountability of participating into that process, to translate the Scientific Data for everybody to be able to understand it. In terms of availability of vaccine, i think very early into the Distribution Process it is likely that the vaccines will be going to the subjects who are going to receive them. As long as sure i would say the month of december and probably early january, thats what were talking about. I think we will start communicating, i think specifically on maybe general can comment further on that, in each state there should be active communication act vaccines now become available for people to go to the vaccine, at cvs or physician and be administered the vaccine. Just to take off where dr. Slaoui left, even this session here, with you, right, asking questions and getting the facts directly from us provides, i think, you know, the American People with confidence, number one. Number two, health and Human Services is working a rollout of a Communications Strategy that will talk about overall confidence of vaccines, never mind covid, but total vaccine confidence. They will narrow it down to the Covid Vaccine itself. And then theyre going to start to establish communication at the national, state and local Community Level on, you know, when vaccines are going to be available to all persons in appropriate time accordingly as said initially, you know, to probably healthcare workers, front line healthcare workers and the elderly longterm clearly been advertised and talked about quite a bit. But then what happens beyond that is where we want to get the messaging out to all americans. So thank you. Next question. Our next question is from candace choi with the associated press. Your line is open. Hi, thanks. How closely will you be urging states to follow priority recommendations and do you have any indications that distributions might vary from the recommendations . And is there going to be any thorough guidance on whether people who have been infected should get the vaccine . So in regard of your second question, here are the facts. In the trials, people are recruited on the basis of not having had overt clinical covid disease, so symptoms, et cetera. On that basis they were recruited. It turns out anywhere between 5 and 10 of the subjects recruited were zero positive to covid19, in other words they most likely had asymptomatic or light symptomatic disease and didnt know it. So what we know is the vaccines is safe in this population and quite significant numbers of se zero positives have been immunized and their responses are being well have high responses to the vaccine because they were already priority through the infection. Where we do not have data is in subjects, individuals who have had overt disease, thats an important question that we will need to address through clinical studies. Now, what we also know from the literature is that people who get overt disease, in general, have a higher immunoresponse to the virus than people who have subclinical disease. So the expectation is for them to be more protected, but that, you know, studies will need to be done. What we do know to the first part of your question is that the staffs at each of the jurisdictions are highly professional, medically trained, and have a clear understanding of the role of the fda and the eua and the cdc asip. And we are 100 confident in based on our deliberation and coordination with them that they understand how to implement their plan in accordance to that. I dont have any indicator that says they would go outside of those things. Next question. Our next question is from anjelica lavita with bloomberg news. Your line is open. Thank you. Will all of the initial doses be available to the states at first or will the federal government allocate any of those doses directly . And if it is the latter, who will they be given to and in what priority order . So right now the allocations are for the 64 jurisdictions, and five federal agencies. But thats theyre all going to go out simultaneous, fair and equitable to the amount that is available. It is pro rata to population. It is insisted on it, it is a math problem in execution. So that we can ensure fair and equitable distribution. Next question. Our next question is from tom howell with Washington Press sorry, washington post. Your line is open. Hey, it is tom howell from the washington times, thanks for doing the call. I wanted to know what youre hearing from the states in terms of their ability to distribute the vaccine. Do they have enough funding to it is one thing to ship it to them today, but enough funding to distribute it or do you need congress to step in and provide more . So a lot of work is going in, in the collaboration and coordination of the distribution to what we would like to see down to the lowest level. And so as long as they have the provider enrolled, ie Doctors Office, hospital, cvs, walgreens, et cetera, then the vaccine can be delivered to those locations. And in theory administered at those locations. If the state chooses that they would rather have it go to certain and we will deliver to those locations. If a state would like to direct a hub, we will deliver to the hub they designate. If they require additional assets and support from there, we have been talking to them about making sure they have a detailed plan with specificity and what the requirement would be and then to let us know so that we can help enable them with that. They have received funding in this light, previously, which with additional funding, up to 200 million with additional 140 million being distributed out to the jurisdictions this month to support them in that execution. Next question. Our next question is from Rebecca Robins, if you would mind stating your organization. Your line is open. Yes, this is Rebecca Robins from new york times. Thank you for taking my question. My question pertains to a vaccine being developed by astrazeneca and the university of oxford. Im curious if you could tell me what the expectation is in terms of the data that will be necessary for the fda to consider an emergency use authorization. Do you anticipate that they will need to submit data from the phase three trial in the United States . And was that the plan . And if so, how long has that been the plan . Thank you. So, first, i should say that the fda defines what the fda would like to see in to the file. And it is not the operation that does that or the company. But having said that, i do think that there is a large set of data coming out of the uk and brazil trial in terms of efficacy and safety. That data is still being digested because of the contrasted outcome that happened in regard of the immunization regiment that was used. And it is not obvious or straightforward to come to a conclusion why there appears to have been substantially different efficacy outcomes, 90 to 62 . And frankly unless there is a very clear explanation based on facts and data of what is behind those two numbers, it is very likely that that vaccine will not be sufficient for approval or be the first one to say, here. But of course the fda will make their own decision. Next to that clinical set of data, and safety data, which is quite important and significant in the numbers is, of course, also the manufacturing data. The fda would want to understand the manufacturing process and the facilities in which the Clinical Trial material used in the trials has been produced and those facilities are in the uk and in italy. For the Clinical Trials conducted in the uk, brazil and also for the Clinical Trial conducted here in the u. S. On top of that, the fda will want to understand and characterize the manufacturing process that has been using here, in the u. S. , at emerging Bio Solutions which is used to produce the commercial vaccine and we need to demonstrate that vaccine is identical technically to the vaccine used in the Clinical Trial. My hunch is that by the time we generate Astrazeneca Oxford university all the set of data, the data from the ongoing efficacy trial phase three in the u. S. With the vaccine will come out. Thats a fully selfsufficient trial. There is no pooling, there is no geographic diversity within it. I think it is a trial that we and the fda have overseen totally and ultimately it may have the largest weight in the decision around that. I dont think it changes a lot the timelines. I still would expect that somewhere in january maybe more towards the second half of january data will become available. And potentially emergency use authorization could be filed. Thank you. Next question. Our next question is from sarah murray with cnn. Your line is open. Hi, thank you all for doing the call. Appreciate it. First i wanted to see if you could tell us the five federal agencies that will be getting the vaccine allotment. And secondly, just to clarify the data systems, will each state be responsible for tracking the first shot and their residents and making sure they come in for the second shot. Is there any sort of federal role in that system or is it all the states . So the five federal agencies are the veterans affairs, department of defense, department of state, Indian Health services, and bureau of federal prisons. The second question about tracking second doses, what we have done is we have set up everything from draconian process where when we sent out the ancillary kits, which have needles and syringes, we included paper cards to be filled out and sent to given to the individuals, reminding them of their of their next vaccine due date, accordingly. Encouragement of taking a photo of it, putting it in the wallet, et cetera, you know. Were working at the draconian level there. Second, states are working plans for notification. Notification and information inside of state laws is very particular in some states very open in others and each state is working that plan inside of their own within the rules and regulations and laws. We do know that pharmacies such as cvs and walgreens have established very elaborate tracking systems, right, to set up appointments, notify people when their second shots are required, et cetera. At the federal level, what were working and we have capability and capacity to send second dose messages out only if and when it is in collaboration with the states, laws and regulations and policies. So triple canopy approach to try to make this work. And were doing our best to capture everybody to ensure that they get their second dose. Thank you. Next question. Our next question is from emily comp, if you would mind announcing your organization, your line is open. Hi, this is emily comp with roll call. I was hoping you could clarify how you drew the chalkli line o december 15th . Was that through conversations with the fda . Is there any pressure on the fda to make a decision by that date given thats what youre planning on . So, you know, im an army general. Army generals plan. So literally i got up on my white board, right, and said, oh, they filed for eua on this day. And then i got word that said the verpak sessions were going to be on this day. They filed, verpak was specified and i said, okay, somewhere in this window, right, after they work through the details, is probably the earliest potential opportunity for an eua. My white board clearly speculates only if the eua approve would distribution begin. But we needed to do an estimated date so we could backwards plan the requirements for distribution. For example, if we think it is coming out on that day, and we wanted to distribute available vaccines immediately following several administrative things have to occur. One, the states need to tell us where they would like the vaccine delivered to, at what quantities. Two, the companies have to prepare the packages and so all 64 jurisdictions times x number of locations times x number of doses has to be prepared and put into storage. Three, the coordination between the major trucking distribution, mckesson, and the primes that are going to support it, fedex and u. P. S. , have to be brought into the plan for execution. And then, four, of course, it is, you know, the notification to the Administration Sites that they will receive vaccine acc d accordi accordingly. In simple terms, it is a white board plan. It is meant to help us prepare. But it is not straining to execution and there is 100 without question no interference with the fda and their very deliberate, arduous effort to make sure that we have the right solution if and when they do approve eua. Next question. Next question is from Caitlin Kenny with stars and stripes. Your line is open. Hi, thank you. Since the dod is getting their own allocation, can you talk about that their Distribution Plan is among the force . Do they have their own priority of who gets the vaccine first or are they following the phase one through their healthcare workers and phase one b for who they believe are essential workers . Thanks. Just like were doing for the jurisdictions, the federal agencies have their own plans. Were supporting them with fair and equitable allocation based on population of their force. And so they will figure out their plan. They well understanding and they have the same professionals that the jurisdictions have in their alignment and execution of the fda and eua guidance and the cdc and asip guidance. I do not know what the department of defenses plan is after that. I think we have time for two more questions on todays briefing and followup questions can be sent to media hhs. Gov. Two more questions. Our next question is from omer afan, your line is open. For dr. Slaoui, you talk about the Johnson Johnson vaccine, how would that affect the plans for distribution . Would operation warp speed ship its resources toward a one dose vaccine or how would that allocation proceed at that point . I mean, first, we need to look into the performance, i should say that strategically we decided with that vaccine to try a one shot vaccine, but at the same time we also decided to test it as a twoshot vaccine. And that phase three trial has started already. So we cover all bases if you wish. In terms of distribution, general perna can comment further, there should be no difference. It is entering into the cadence of distributing the dose, except there will be no recall to the subject that received the first dose to come back. It is going to be effectively a more efficient faster strategy to immunize. Just particularly important in when there is a very active pandemic and thats the reason we wanted to assess the potential. Thank you. It would be additive to the amounts that were sending out for moderna and pfizer. And then we would do our initial push based on eua and what is available. And then we would put them in the cadence as dr. Slaoui indicated in normal routine distribution accordingly so states and jurisdictions would then have three vaccines, to distribute to their plan. Final question, please. Last question is from andrew dunn with business insider. Your line is open. Andrew . Go ahead, sir. We cant hear anything. Somebody is on mute. Operator to the next question. The next question is from hasam ahmed with asp, your line is open. Thank you for taking my question and doing this interaction. Can you hear me . Yes. Yeah, so i had a question for dr. Slaoui. If youve been following it all, the russian data from with regarding to the sputnik vaccine, which i know they havent accrued that much, but it looks relatively promising, i wonder if you have any thoughts regarding that and whether that could ever be a possibility for the u. S. And the second part of the question was do you expect all 3 million nursing home residents and most healthcare workers to be vaccinated by the end of this year . So regarding the first question, very scarce access to any data. Only whatever is in the public domain. The one thing i would comment on is that the vector used, which is human adenovirus 5 has been associated in hiv connected trials with an increase d susceptivity to acquiring. So a word of caution as to exactly what kind of molecular engineering might have been done on their vector to avoid what should obviously be avoided, which is increased susceptibility to acquiring hiv. I believe it was in the male population. As regard to the vaccination of the longterm care facility residents, elderly, frail people, it is really going to be a decision that will be based on the recommendation from the cdc and Advisory Committee on immunization practices, as well as the adherence or variance from that recommendation by the each state health agency. So not for us, what i can say is that we will be ample amount of vaccine available to immunize 3 million such residents. By the end of the month of december. Thank you, dr. Slaoui. Thank you, general perna. Thank you everyone for joining. Thats all the time we have for coronavirus case is increasing across the country. Use our website to follow the trends. Track the spread with interactive maps and watch atates on demand, anytime coronavirus. The house is back at 10 00 a. M. For legislative speeches. The house will work on legislation that would decriminalize marijuana. On cspan2, the Senate Considers judicial and executive nominations. Cspan3, the Justice Department reviews the fbi oversight investigation. In the afternoon, the Aspen Institute hosts a cyber summit with members of congress and the acting director of the agency. Urity tv on cspan2 book tv on cspan2. Coming up this weekend, coverage of the 71st annual National Book awards. Conversation a with author and chair of African American studies at princeton university. Hes the author of several books democracy exodus, black, and an uncommon face. We are at a crossroads. Who are we going to be . At the heart of it all has always been this moral question. Who do we take ourselves to be . Join the conversation with your calls, tweets, texts, and facebook messages. Ds, the politics and efforts of the everyday white appalachian america. Book tv on cspan2 this weekend. Dr. Robertctor redfield is warning the next few months could be the most difficult period and u. S. Public Health History due to the coronavirus pandemic. He spoke with the u. S. Chamber of commerce president about the recent surge in cases, what americans should be doing to mitigate the threat, and how the u. S. Might prepare future pandemics. This is just over one hour