Applications with the fda. Three companies ha shown promising data for efficacy and ase three trials. Tore owif that supported candidates are on the way in the final phase of Clinical Trials. Fda has now scheduled a meeting the Vaccine Committee to review on december 17 foowing pfizer meeting on december 10th we also learned this morning the United Kingdom is grted mthorization to the fraser vaccine. To have enougho vaccinate ery american who wantit because of operation warp speed we expect to be at that point i the spring. Having substantial quantities of th safee and effective vaccine thats been authorized by the fda before the end of the year is a remarkable aievement and willtart saving lives very soon. As all o of you likely know yestery the cdc held a meeting on immunization practices that issued recomndations to the leadership o how vaccines can be equitably distributed. These recommendations will be used bytates to develop the best prioritization system for thei own citizens. States have different circumstances and are i different epidemiological situatns and state leaders are in the best positions take the general recommendations and translaters them into mor precie guidance for thetates and conditions. As we approach the vaccine rollout we are also continuing to expand accesso treatment forovid19. As of this week weve distributed more than 150 authorized antibody products across the United States and allocated for delivery to stat. More than 300 sites are currently signed up toffer theser trements. We also launched a Pilot Program to explore how to reach the vulnerle treatments and more convenient locations. As weve mentioned, americans need to know that this treatment is a possibleption for patients at high risk for severe covid19 i but who have not been hospitalized. That includes all americans over the age of 65. Thats the definion we are using in this case for the risk ofevere covid19. Receiving thisreatment if you are in th cegory could help treat yo and potentially helping to save your lives. As we wa to encourage the news media to spread t word about the availability of covid19 treatment and we want to encourage americans to art playing the role they will have in an eventual vaccine, tac. Vaccines will oy bring this pandemic to an end if enough americans choose to take the vaccines. We now have highly promising efficy data that i believe Many Americans are encouraged uand excited about. I want to encourage americans to get prepar and educated now. Visithe website to find out more about the vaccines we are developing in the process theyve gone through. If you have questions now are further down the road, talk to yo Healthcare Provider about the importance that they hav thr own health and the health of our communities. These products will be assessed en it comes to any other vaccine or drug reviewed by the fda. As each of us has said we are excited to take the vaccine and we will encouge our family and usfriends to do so as appropria. I apologize i wont be able to stay throughout todays qanda because of another engagement, but will be back next week for the full hour but before i close, i would like to make a plea to individuals that have had covid19 and have recovered. If you are within three months sinceak the recovery, we need yu to donate plasma. Over a quarter million courses of convalescent plasma have been used on your fellow americans to help prevent severe consequences from cid19. We unfortunately have soany individuals who have gotten covid19nd have recovered now fortunatelyny but we need donations. Plse contact your local american red cross, your local american b blood bank or go to coronavirus. Gov about more information to give the gift of life. I will turn things over to the capable hands ofhe leaders who willead the rest of the briefing and i will see you at this briefing next week. Thank you very much. A few points to add. Very rich new information. The final analysis has been completed with 94. 1 efficacy against the disease and importantly, there were 30 cases in the trial. So 100 efficacy. There were 7,500 some age over 65 there were no cases in the Vaccine Group and i think those are very important to keep in mind. It is exceptionally good data and remarkably similar to the data you have already seen and the fact that an external of the standards according to those at the fda has approved the vaccine. Of course they have not been involved in the politicization that surrounded the development of the vaccines and i hope this will be another evidence for the American Population that the data are clear, transparent and demonstrate that they are effective and safe for the use in the general population because as the secretary said, they are useless if they are not used to vaccinate people. I think also great progress with two other vaccines in the pipeline the Johnson Johnson vaccine, which is now recruited a little bit more than 28,000 subjects in the trial. The breakthrough that we had is that its a oneshot vaccine rowith very fast efficacy achied and 100 compliance so to speak. It would be very important by the way for all of those that get the vaccine to then come back to get the second to complete. The next is astrazeneca. The phase three trial conducted here in the u. S. And under the operation warp speed oversight so different than the uk and brazil that have been communicated about last week is progressing very well. Both Johnson Johnson and astrazeneca are likely to complete the requirement somewhere between very late in december and the middle of january given unfortunately it is extremely active and there is a lot of transmissions in the population. In closing on the vaccine i would like to remind you all that fortunately the investments weve made in stockpiling the vaccine allow us to feel confident we will be able to immunize 20 Million People in the u. S. In december between mid december and the end of february people with corbidity today i just want to talk quickly about threthings. Allocation updates, disibution and support of the state plans and the ability to execute their plans and third, to reinforce the challenge t the secretarys comments at the end about learning about vaccines. So, first reference allegations. Wead provided the 64 jusdictions which is a reminder that 50 state eight territories and six cities as well as five feder agencies with their allocations of the vaccines are going to be available in e month of december. What we have done is we believe for planning purposes only, we had to pic a date and i coined the phrase so we could plan on actual doses that would be availabl so a week and a hal ago we ovided the jurisdictions and five federal agencies and allocationsor the vaccine of a total of 6. 4 million. A week later on the 27th of november, we provided the 64 juriictions and five federal agencies and allocations for the motor and a vaccines that would be available. Again, we are planning to be ready when approved. Its not about getting in front of it. Its jt about making sure that we hav everything locked so when the decision comes, the distrition to the american pele comes immediately within 24 hours. That is the goal a what we are strivi for and whate are working too. You cannot execute if you do not have a plan and that is what the emphasis is as we work through that process. We w are going to send half of e doses based on allocationso the jurisdictions and agencies because it is a two dosregimen and was talked about. So, half of the allocation will beent out and then 21 days later for pfizer and later we send out the second half of the allocation to ensure we dont over administer and we have a second doson hand and the send reason is to make sure we do not overwhe limited storage capability and capacitie at t state level. We want to augment their plans, not constrain them from t greatest distribution capability that they have. We utilize the platform that we deloped which is the capability that takes in all of the in the formative data from the states, hospitals, Doctors Offices, pharmacies only on the specification of the vaccine as it is delivered and the vaccine ioas it is administered so we cn maintain the flow to the american people. Aser i talked about, our goal is to distribute within 24 hours after the eua a then we want toaintain a deliberate plan coordinated cadence of delivery of t vaccine as it beces available. We have t see ourselves from the point of administration all the way back to the point of finish. In doing so, we can coordinate, collaborate, plan together the the vaccinesof down to the states. We have requeed the states lock inhe the final distribution of both vaccines so for example this week we asked the states and total jurisdictions to have their plans a by the end of the week or for december, this way we can understand we have all the places we want the vaccine delivered and athat antities and then we can coordinate to ensure they are prepared and ready to be distributed. Addresses in the system, coordination with t master distributor through fedex, ups and then down tthe administration sites. A key effort by everybody. Weve asked for the states and jurisdictions to have their plans ready forst the vcine by the 1h of december which allows tm to do the same planng and what happens is the vaccine comes into wherehey want and it enables their plan for immediate administratio of the vaccine to the priorities that their governor establishes that each sta. Heres the key, the statesnow thr people and populations the best. As they flow through the guidance that was put out yesterday, you have leaders taking responsibilitynd directing the priority of the vaccine administrations or shots in the arms. Our responsibilitys to enable the plan to empowerheir plan and thats why weve asked for the micro planning a the detailed work to have an accordingly. Afterfo the initial push goes ot for pfizer, then every week based on availability of the vaccine as was dilutedt two, 24 million total doses in december and the january, aifebruary and march, we are gog to publish allocatio as the vaccine becomes available we are not waiting for the clusr of the vaccines to be available and then phed. We want to have a dramatic cadence the delivery to the vaccine so that the states can best managet to the priorities as thedeveloped it. We visualize each week additional vaccines getting out and eventually we just continue to build on the amount of people thatet vaccinated and thats on our way to ending this pandemic. The jurisdictions thennd governors quite frankly will deci where they want to go at the end ofic the day. And we are enabling them to that d. So, i just wanted reinforce at this point allocations made, jurisdictions planning we try to enable them toork through their priorities to best take care of the people of their jurisdictions accordingly. Second, i would like to talk out how we are working to empower the states and make sure that they are well informed of all of the processes that we have available. I just wanto commend the cdc for the remarkable work that they are doing. These great lders, these very, very talented professionals, welltrained experts in this fieldf distribution have set up an elaborateoordination and collaboration efforts with the states. Theyve ruthey run daily, weekl. They work through detailed execution of plans. They make recommendations on how best to fzle ties and operationalize a distribution and then they figure out ways to enable the states and jurisdiction plans. Really well done by the cdc and i am proud to be a part of the collaboratio with them. Second, we worked a very elaborate update in talking to the governors either throughhe hhs or up through the Vice President mike pence sessions with them. But also through individual phone calls to the governors, to thr health w coordinators and the seni leadership level to make sure we are answering questions in a timely manner and gettingrd them solutions we want to enable and empower the jurisdictions to execute their plans. That is ourh gl and responsibility t do. And we have workedxtremely hard two things ive coached people on. Overommunication is an asset tove our execution. And then second, you know, youve got to do the virtual circulation. We have to see what the governors and their staff are seeing so we can best enable them. One ofwe their concerns they are working througis how to do rsing home longterm healthcare facities. The cdc andhe o ws collaborated with other pvate pharmacies to enable state governnt plans on getting to those facilities. How do we get it out to them and make sure thate are there to administer to them, and i am incredibly confident that these private public ptnerships are readyde to executeased on the priorities and pla to do so and im exciteded to watch that. Thlast thing that i will leave you with is the Great Potential and efficacy of the vaccine is as weo forward, the vaccine is only goo as that being administered to the american people. And so i would ask everybody to educate yourself, figure out what you want to do a an individual but be informed in the process. Dont aow one headline to deteine what youou are going to do. Theres so much available informatn and would just anourage everybody as individual to inform yourself and make the decision that is best for you and you family. So, with that. Thank you. R. We will open up for questions now. And a reminder please state your me implication and keep your questions as shorts possible to get to as many as we can in the timee have and we will turn over. We wilnow begin the estion and answer session if you uld like to ask a question please press star one. Report your name and organizaon when prompted and to withdraw the question [inaudible] once again at this time if you would likeo ask a question, ease presspt star one. The first question is from nick turow if you wouldnt mind stating your organization. [inaudible] with cnbc. Gai wonder if you can just go bk through the allocation numbers per month that you laid out. I want to make sure that weot itr. Right. The 30 million by december and 60 million in january, 100 million in february; is that set by the vaccine and is the followup on something the general was saying with only half the dose is being sent out and the second half being followed up what i the right way for us to talk about the number that will get their first is that a 6. 4 million getting their first shot we oftenivide by two so wt is the right terminology for us to be using . Thank you for the question. So indeed i used the nber to be vaccited with a complete dose of the vaccine, so two shots. 20 milon in december, 30 million in january, 50 million of february, and that is with the vaccine. There is a chance that we may have more Vaccine Doses Available in february, particularly with the emergency use authorization approval. As i said, it isossible depending on the number of cases if it completes the efficacy in the month of january, so maybe could have a little bit more. We will watch it equals one vaccine and my recommendation ia to use a numbe of people i think that its more factual, more realistic. The next question is from john collins with science magazine. You praised the vision but in europe theyve criticized as being hasty and its meant to build cfidence. Others are heavily criticizing. We dont know ectly how the process has taken place. As you know, we stay totally away from th regulatory process whethe it is the fda or others. What we understand is thathere have been rolling submissions where different parts have been submitted at different points. I would speculate it has been filed quite a while ago and therefore potentially the review has focused onhe rest of it having been done earlier but i cannot comme. I woulagree completelywe know ta completely transparent process with independent experts commenting and asking questions and recommending or advising the agency i know personally from my experience that it is an extremely highgrade ency. In fact before they left it it was the scientific engine of t uk and the german part of the agency. Thank you. Our next question is from zachary brennan. Please state your organization. Is open. Thank you for taking my questions. The general mentioned earlier that about 21 jurisdictions still havent signed on to these data user agreements. Whats going to happen with those ifhey ultimately do not sign onto those and then can you talk a little bit abouthy tcertain vaccines are saying tht they are smaller than what they originally had thoht . First question we are down to 17 and we are getting to the last dot the i and cross that he and am very confide that all of the jurisdictions will he the data use agreements in and everything will be all right. To w yr second question, what we are doing is insad of waiting until the end of december when we know we will have a cumulative amount of the vaccines as was mentioned, and i reinforced the 40 million doses, what wer we are doing is at the we speculate its going to occur the doses that will be available, 6. 4 milon for pfizer and 12. 5 for thats what we did t initial allocation based on. So, that push will g out based on those allocations but eve day that goes by after the itial push, additional vaccines come of, ftheshelf be they have been certified and approved forhe distribution and administration, hence what i talked about in the continuous cadence of the delivery of the vaccines going out to the american people. So, it is not a one and done. It is an initial potion and then a continuous cadence flow of vaccines for planning and coordination and execution. Thank you. The next questio is from stephanie with abc news. Yourur line is open. Thank you. I want to follow up on that. When you talk about the continued cadence of delivery, how will the amount be allocated and is it correct to say each subsequent divery would be followed by a delivery of the same amount of 2 21 or 23 days . What we are doing is through the program we established located ator the jurisdictions e are establishing the available doses of the vaccine to each state so theyet to see that. It alls them to see the allocation. It allows them to go through a anning process of where they would like to have the vaccine to go to and manipulat manipulay can e the impact of the doses going to those locations and once its finally approved they hit send and that is how we distrite. As we go forward and the answer is yes. Our responsility is to make su we have both directions in hand before we send the first dose out that way be are confident the second will be available for everybody as they are administered their shots. Thank you. The next question is for bio century the line is open. Caller are there any systems in place for tracking outcomes for people who are vaccinated . The registry or other systemste to determine what the outcomes are on the ongoing basis . The fda and cdc are working closely together to