Phase of Clinical Trials. The fda has now scheduled a meeting of its Vaccine Advisory Committee to review the Moderna Vaccine on the 17th 17th following their meeting of december the Pfizer Vaccine on december 10. 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 issued recommendations to our leadership on how vaccines can effectively and equitably be distributed. These recommendations will be used by states to develop the best prioritization 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. Them into more preci 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