Army Gen. Gustave F. Perna, chief operating officer of Operation Warp Speed; Dr. Moncef Slaoui, chief advisor to Operation Warp Speed; and Health and Human Services Secretary Alex M. Azar II brief the media on Operation Warp Speed and COVID-19 vaccine distribution, December 2, 2020.
Transcript
So much for joining our weekly operation 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 Madonna’s announcement on Monday, two companies have now filed you applications with the FDA. Out of the three companies that have shown promising data for efficacy and Phase three trials on top of that mawr O. W s supported candidates are well on their way in that final phase of clinical trials. FDA is now scheduled a meeting of its Vaccine advisory committee to review the Madonna vaccine on December 17th, following their meeting on the Pfizer vaccine on December the 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 Purna will lay out, that means we can make our first shipments of vaccine two states this month and we’re on track to be able to ship enough vaccine for 20 million Americans before the end of the year. Of course, we’re all eager to have enough supply toe vaccinate every American who wants it. And because of operation warp speed, we expect to be at that point in the spring. Having substantial quantities of a safe and effective vaccine that’s been authorized by 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, 600 held a meeting of its advisory committee on immunization Practices, which issued recommendations to our leadership on how vaccines can be effectively and equitably distributed. These recommendations will now 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. As we approach the vaccine roll out, we’re also continuing to expand access to treatments for Cove in 19. As of this week, we’ve 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 3000 sites are currently signed upto offer these treatments. We’ve also launched a pilot program that will explore how to reach vulnerable populations with these treatments and offer the treatments and 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 Covad 19, but who have not been hospitalized. That includes all Americans over the age of 65. That’s the definition we’re using in this case for risk of severe Covad 19. Receiving this treatment, if you are 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 Covad. 19 treatments and one encourage Americans toe start playing the role that they’ll 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 C. D. C s website. Find out Maura, about the vaccines we’re developing in the process they’ve 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 tow 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, we’re excited to take this vaccine and we will encourage our family and friends to do so to as appropriate. Now, I apologize that I won’t be able to stay throughout today’s Q and A because of another media engagement. But I will be back next week for the full hour. But before I close, I’d like toe just make a plea to individuals who have had Covad 19 and recovered. If you’re within three months since recovery from co vid 19, 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 Cove in 19. We, unfortunately, have so many individuals who have gotten Cove in 19 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 form or 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 Moncef Slowey and General Gust Purna, who will lead the rest of this briefing in the q and A. And I will see you at this briefing next week. Thank you very much, Doctor. Sloppy. Thank you, Mr Secretary. Just a few points to add Thio. I think the excellent summary that Secretary has provided very, very rich week in new data and information eso on the Moderna vaccine side of things. Uh, the final analysis has now bean completed with 94.1 efficacy against moderate and severe disease. Importantly, there were 30 cases of severe disease in the trial. All 30 in the placebo group. So 100% efficacy. There were 7, 500 some elderly people with aged over 65 and efficacy in that 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 this exceptionally good data and in fact remarkably similar to the data that you have already seen coming from with the Pfizer vaccine. And obviously, as the secretary said, the fact that a next IRNA Lee regulatory agency of the highest caliber and standards equivalent to those of the F d a the U. K M A Cherry has approved the fighter vaccine. Of course, they have not been part and involved in any of the politicization that surrounded the development off this vaccine, and I hope this will be another evidence for three American population that data with these vaccines are clear, are transparent and demonstrate that they are effective and safe for use in the general population because, 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 that Johnson and Johnson vaccine, which is a recombinant human adenovirus 26 uh, vector has now recruited a little bit more than 28,000 subjects in the face retrial. Now that the breakthrough that we hope with this vaccine is that it’s a one shot vaccine with very fast efficacy achieved and 100% compliance, so to speak, since everybody you get one shot, get the full vaccination schedule. It will be very important, by the way, for all Americans who get the Moderna or the fighter vaccine to have their first vaccine, those and then come back either three or four weeks later to get their second vaccine. Those to complete the immunization schedule. The next vaccine in the line is the AstraZeneca chimpanzee Adenovirus Life Vector vaccine. The face retrial is conducted here in the U. S. Under the Operation Warp Speed Oversight. So it’s different trial than the UK Brazil trials that have Bean communicated about last week is progressing very well. We have about 15,000 subjects recruited in the trial, both the Anson trial and Johnson and Johnson and the AstraZeneca trial are likely to complete their efficacy requirement, which is the number of cases accruing in this study somewhere between very late in December and the middle of January. Given, unfortunately, that the pandemic is extremely active and there’s a lot of transmission in the population in closing on the side of vaccine. 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. There’s 40 million doses than 30 million people, $60 million in January and 50 million people or 100 million doses in March. So between December mid December and off in in February an end of February, we will have potentially immunized 100 million people, which is really more or less the size off the significant at risk population, the elderly, the health care workers, the first line workers, people with co mobility. I’ll close there. Of course, be happy to answer your questions later on, passed on to general partner great Thanks. Dr. Slowly has always incredibly well informative for us. Uh, all right. So, team today, I just wanna talk quickly about three things. Allocation, update our distribution in support of this state plans are our ability to empower them to execute their plans and then third just to reinforce the challenge. My word, uh, to secretary a czar’s comments at the end about learning about vaccines. So, you know, first reference allocations we have provided the 64 jurisdictions with the reminder is the 50 states, eight territories and six megacities a swell as five federal agencies, with their allocations of the vaccines that are gonna be available in the month of December. What we’ve done is, we believe, for planning purposes on Lee, we had to, uh, pick a day, and I’ve coined the phrase snapped the chalk line so that we could plan on actual doses that will be available. So, for example, but week and a half ago, or on 20 November through Tiberius, we provided the 64 jurisdictions and five federal agencies their allocations for the Pfizer vaccine of a total of 6.4 million doses that will be available ah, week later on 27 November, we provided to 64 allocation jurisdictions and five federal agencies. Uh, their allocations for the modern A vaccine at 12.5 million doses that will be available again. We are planning to be ready when you A is approved. It is not about getting in front of you. A. It’s just making sure that we have everything locked. So when you a decision comes, distribution to the American people becomes immediate within 24 hours. That’s our goal. That’s what we’re striving for on that’s what we’re working to. You can’t execute if you don’t have a plan on. That’s what our emphasis is. Aziz. We work through all that process. Uh, we are going to send half the dose is based on allocations to the jurisdictions and agencies. Uh, because it is a two dose regimen as Dr Salah we just talked about so half of the allocation will be sent out and then 21 days later for Pfizer and 28 days later for Madonna, we send out the second half of allocations, two reasons. One to ensure that we don’t over administer on, that we have the second dose on hand on second reason is to make sure that we don’t 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 you utilize the Tiberius platform that we developed right, which is, uh, capability. That takes in all the informative data from the states, uh, hospitals, doctors, offices, uh, pharmacies on lee on the specifications of vaccine as it is delivered on vaccine as it is administered so that we can maintain the flow of vaccine to the American people. A Z I’ve talked about. Our goal is to distribute within 24 hours after eu A on the first pushes. Then we want to maintain a cadence, a deliberate, uh, planned, uh, coordinated cadence of delivery of vaccine as it becomes available. The only way you could do that is if you see yourselves and we have to see ourselves from point of administration all the way back to point of Phil, finish on. In doing so, then we can coordinate, collaborate, plan together the distribution of vaccines down to the States. We have requested that the state’s locking their micro plans for final distribution of both vaccines. So, for example, this week we’ve asked the state’s, uh, in total jurisdictions that 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 fights or to ensure those boxes are are prepared on, ready to be distributed upon you. A addresses in the system. Coordination with McKesson, the master distributor, through FedEx UPS and then down to the administration sites Really a key effort by everybody. Uh, we’ve asked for the states and jurisdictions that have their micro plans ready for the modern A vaccine by the 11th of December, which allows them to do the same planning on 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. Here’s the key. The states know their people, their populations the best. And as they follow through with you, a eventually you a guidance and the acid guidance that was put out yesterday. Then you have leaders taking responsibility and directing a pariah price priority vaccine into administration or shots and arms are our responsibility is to enable their plan to empower their plan on. That’s why we’ve asked for the micro planning on the detailed work toe happen accordingly. After the initial pushes go out for Pfizer and Madonna, then every week, right? Based on availability of vaccine as Dr Salah, we alluded to 40 million total doses. Uh, in December and then January. February March. We’re going thio push allocations as vaccine becomes available. We’re not waiting for cluster of vaccine to be available and then push. We wanna have this rheumatic cadenced delivery of vaccine so that states can best manage it to the priorities. Aziz, they’ve developed it. We in visual eyes, uh, each week, additional vaccines getting out and eventually we just continue to build on the amount of people that get vaccinated, enhance on our way to ending this pandemic Jurisdictions and the governor’s, quite frankly, will decide where they wanted to go on the end of the day on, we’re enabling to that end, So I just would reinforce in this point here allocations made jurisdictions planning. We’re trying to enable them thio work through their priorities. Thio best take care of the people of their jurisdictions accordingly. Second, I’d like to talk to you about, um how we’re working to empower the states on make sure that they are well informed of all the processes that we have available. I just want to commend the c d. C for the remarkable work that they’re doing. These, um, the’s great leaders, these very, very talented, uh, professionals. Well trained experts in this field of distribution have really set up an elaborate coordination on collaboration effort with the states. They run daily weekly meetings. They work through detailed execution of plans. They make recommendations on how the best facilities eyes on operationalize the distribution on. Then they figure out ways to enable the state and jurisdiction plans really well done by the CDC. And I’m pretty proud to be a part of the collaboration with them. Second, we worked a very elaborate update, uh, in talking to the governor’s, um either through HHS or up through Vice President Pence’s, um, sessions with them, but also, through individual phone calls to the governors to their health coordinators, A to the leader senior leadership level to make sure we’re answering questions in a timely manner on getting them solutions to their problems again. We want to enable and empower the jurisdictions Thio execute their plans. That is our sole goal our responsibility to do. And we’ve worked extremely hard. Uh, two things I’ve coached people on over over communication, uh, is an asset to to our execution on then. Second, you know, you 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 the one of their concerns that they’re working through is how to do, uh, nursing homes, long, long term health care facilities, right in the C. D. C. And O. W s collaborated really worked a very extensive plan. Uh, in collaboration with CVS Walgreen on other private pharmacies to enable state governor plans on getting to those, uh, facilities. How do we get it out to them? How do we make sure that we’re there to administer to them on? I am incredibly confident that thes private public partnerships are ready toe execute based on the governor’s priorities and plans to do so on. And I am excited. Uh, toe watch that to get operationalized the last thing I’ll leave you with in touching with Secretary is ours. Comments on reinforcing Doctor Salahi’s comments on really the great potential and efficacy of the vaccine is as we go forward. Vaccine is only good as it being administered to the American people on DSO. I just ask everybody to to really educate yourself, right? Figure out you know what you want to do as an individual, but be informed in your process. Don’t allow one headline to determine what you’re going to do. Uh, there is so much available information on I just encourage everybody, uh, as an individual. Ah. Community on, of course, is a part of our great nation to really inform yourself and then make the decision that is best for you on your family. And so, with that slow, I think take questions, her questions. Thank you, operator. Well, can open it up for questions now, on a friendly reminder, uh, to remove your friends that we’re asking a question, please state your name and publication and please keep your questions short as possible so we can get to us many questions as we can in the time that we have alternative routine. Operator. Thank you. We will not begin the question and answer session. If you would like to ask a question, please Press star one, please. I meet your phone. Ever important first and last name as well as your organization. Clearly, when prompted to withdraw your question, you may press start to once again at this time. If you would like to ask a question, please press star one. And our first question is from Meg. Carol, If you won’t mind staying your organization, your line is open. Thank you. It’s Meg’s around with CNBC. Um, Dr Sally, I was wondering if you could just sort of go back through those allocation numbers per month, but you laid out. I wanted to make sure we we got it right. You know, the 40 million doses December 60 million January 100 million in February. Is that just fighter and modernist vaccines? And then to follow up on something general partner was saying with only half the dose is being sent out and then 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 1st 6.4 million? Is that 6.4 million people getting their first shot? We often divide by two and say it’s enough for 3.2 million people. So what is the terminology for us to be using? Thank you, Mike for questions. So the numbers were indeed, and I used the number off people to be vaccinated with the complete those of vaccines or two shots. 20 million in December, 30 million in January, 50 million in February. And that’s with the fighter and modern A vaccine. There is a chance that we may have mawr vaccine. Those is available in February, particularly with the young sons vaccine. If the Jenson vaccine gets in emergency use, authorization approved. So, as I said, it’s possible depending on the number of cases accruing that that face retrial completes its efficacy endpoint during the month of January. So there may be a scenario we could have a little bit mawr with a one shot vaccine with that vaccine one those equal, one person immunized. My recommendation is to use a number of people immunized. I think it’s it’s more factual. I mean more really two people. Our next question is from John Collins with Science magazine. Your line is open. I am. This is I am you pray, Doctor slowly and, um, secretariats are praised The vision by the HR A tow, either. But the Iemma in Europe and many European leaders have early criticized that is, being hasty on our own. FDA process obviously is transparent and slower, meant to build confidence. I wonder whether you want to clarify thing that others are heavily criticizing in Europe. But, um, we don’t know exactly how the process has taken place. A. Z. You know, we stay totally away from the regulatory process, whether with the FDA or with others. What we understand is that there have bean rolling submissions where different parts of the file to be authorized have been submitted at different times. Point, I would speculate that fighter manufacturing CMC part of the file must have been filed quite a while ago. Andi therefore potentially the the review has focused on the clinical side, the rest of it having been done earlier. But frankly, I cannot commit. What I would agree with you completely is. We know the FDA process. It’s 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 life that the HR is an extremely high grade agency. In fact, within the Iemma before they left it there, certainly the the scientific engine, the U. K and the pie German part of the agency. Thank you. Yeah. Our next question is from Zachary Brennan. Um, please state your organization, if you may. Your line is open. Thanks for taking my question back from Politico. So, uh, General Purna mentioned earlier that about 21 jurisdictions still haven’t signed on to these data user agreements. What’s gonna happen with those jurisdictions if they ultimately don’t sign onto those on, then can you talk a little bit about why certain states air saying the vaccine allocations they’re a lot smaller than what they originally had thought. So yes, it’s So first question, we’re down to 17. We are really getting to the last dot the I cross the t and I feel very confidence that confident that all the jurisdictions will have their data use agreements in, uh and everything will be alright. Uh, to your second question, what we’re doing is is instead of waiting until the end of December, where we know we’ll have a cumulative amount of vaccine Is doctor slowly mentioned and I reinforce that 40 million doses? Um, what we’re doing is at the time of we speculate you a is gonna occur. The doses that will be available a 6.4 million for Pfizer and 12.5 for Moderna. And that’s what we did the initial allocation based on on DSO. That push will go out based on those allocations. But every day that goes by after the initial push, additional vaccines come off the shelf because they’ve been certified, um, and approved for distribution and administration. Hence what? I talked about the continuous cadence of delivery of vaccine, uh, going out to the American people. So it’s not a one and done. It’s a initial push and then a continuous uh, cadenced flow of vaccine, uh, for planning and coordination and execution. Thank you. Our next question is from Stephanie Ebbs with ABC News. Your line is open. Thank you. Something upstream, ABC. I wanted to follow up on that general per note. When you’re talking about the continued cadence of deliveries, how will the amount in those deliveries be allocated on? But is it correct to say that then each subsequent delivery would be followed by a delivery of the same amount 21 or 23 days later? So what we’re doing is through Tiberius, the program that we established, which is located at each of the jurisdictions. Um, we’re establishing the available doses of vaccine Thio each state on DSO. 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 toa have the vaccine to go to manipulate it so that they can see, you know, impact of the dose is going to those locations. And then once it finally approved, they hit sand on. 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 don’t remember it. Anybody help me on that one. I can’t remember because it was the allocation in states how we are located. Those two have said, Yeah. So Perata. Oh, I apologize. I apologize. Thank you. So the second part of the question was is, are we gonna hold the second dose? Uh, for every distribution as we go forward in the cadence. And the answer is yes. Our our responsibility is to make sure that we have both doses in hand before we send the first dose out. That way, we’re always confident that the second dose will be available. Um, for everybody a z get administered their shots over. Thank you over. Our next question is from Steve House. In with Bio Century, your line is open. I I wanted to ask if there any systems in place for tracking outcomes for people who are vaccinated. Are there any registries or other systems for determining what the outcomes are on an ongoing basis? Yes. So the FDA and the CDC are working very closely together to put together a very active, far Michael vigilance and surveillance system, using various very large databases currently in use on integrating all the data from those databases with potentially frequencies off assessment off events as frequently as every other day, which, frankly, gets even closer than what happens in a clinical trial. On that, the covered population will be very, uh, very large. Include large elderly populations large, uh, V a related population Andi on global population through ah, various insurance carrier. 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. Um, if you if both gentlemen could once again, uh, talk about the whatever pushes being done from a messaging standpoint to encourage as many people to, um, get vaccinated to quell their fears, uh, and really inspire them to take this action. Um, And on the back end of that, how do people know, Or how will people be able to know? We’re talking about general population now, um, when they would be able to get a vaccine either at their doctor’s office or corner drugstore. So I think it is. Every experts frankly duty today as we get Mawr and Mawr exposed to the data, which will become totally public at the time off. FDA review with the verb pack 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, too. The people that they interact with because I think what I what I say is for everybody to keep let’s keep our ears open in our mind, receptive to the information that the factual information on the performance of the vaccine, both its safety and it’s efficacy and then make our judgment whether we will use it or not. And the experts across the country should should take accountability off participating into that process that translate that’s 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’s likely that the vaccines will be going to the subjects who are going to receive them, Asl Ong as surely I would say in the month of December and probably early January. That’s what we’re talking about. I think we will start communicating and specifically and maybe general panic and comment further on that in each state, there should be active communication as vaccines now become available for people to go to the vaccine Walgreen or CVS or elsewhere or or their physician on be administered the vaccine. Yeah, so just Thio just take off where doctors are We left is even this session here with you, right? Asking questions and getting the fax directly from us. Uh, provides I think you know the American people with confidence. Number one, number two, Health and Human Services, uh, is working a roll out of a communication strategy? Uh, that will talk about overall confidence of vaccines. Never mind Cove it, but total vaccine confidence they will narrow it down to the co vid vaccine itself on. Then they’re going thio start to establish communication at the national state and local community level on, you know, when vaccines were going to be available to all persons inappropriate time accordingly. A said initially, uh, you know, to, uh, probably healthcare workers frontline healthcare workers and then, uh, the elderly, long term, 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 Candice Choi with AP the Associated Press Your line is open. Hi. Thanks. How closely will you be urging states to follow a priority recommendations? And do you have any indications that they distributions might vary from those recommendations and if they’re going to be any federal guidance on whether people who’ve been infected should get the vaccine? So in regard of your second question, here are the facts In the trials, people were recruited on the basis off not having had overt clinical, covet disease or symptoms, etcetera. On that basis, they were recruited. It turns out, anywhere between five and 10% of the subjects recruited we’re syrah, positive to covet 19. In other words, they most likely had asymptomatic or very mildly symptomatic disease and didn’t notice it. So what we know is that the vaccines are safe in these populations and quite significant numbers off Syria. Positives have been immunized and their immune responses are being analyzed. My expectation is that they would have very, very high immune responses in response to the vaccine because they were already private through the infection. Where we do not have data is in subjects in videos who have had over to disease. That’s an important question that we will need thio address through clinical studies. Now what we also know from the literature is that people who get overt disease in general have higher immune response to the virus and people who have subclinical disease. So the expectations is for them to be more protected, but that studies will need to be done. What we do know, uh, to the first part of the question is, Is that the staffs that each of the jurisdictions are highly professionals, medically trained and have a clear understanding of the role of the FDA and the U. A and the C D. C slash a sip on. 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, And I don’t have any indicator that says they would go outside of those things. Next question. Our next question is from Angelica La Vita with Bloomberg News. Your line is open. Thank you. Well, all of the initial doses be available, um, to the states at first. Or will the federal government allocate any of those doses directly? And if it’s the latter, who will they be given to and what priority order? So right now, the allocations or for the 64 jurisdictions on five federal agencies. Um, but that’s they’re all gonna go out. Simultaneous, fair and equitable to the amount that’s available. It’s pro rata to population. It is. It is a insisted on it. It’s a math problem and execution so that we can ensure fair and equitable distribution. Next question. Our next question is from Tom. How you with Washington Press? You’re like, Oh, I’m sorry. Washington Post, Your line is open. Hey, it’s, uh, Tom. How from the Washington Times. Thanks for doing the call. Just wanted to know what you’re hearing from the States in terms of their ability to distribute the vaccine. Uh, do they have enough funding? Thio. It’s one thing to ship it to him to have enough funding to distribute it for Congress to step in and provide more. So a lot of work is going in the collaboration and coordination of the distribution to what we would like to see down to the lowest level. And so a zloty as, uh, they have the provider enrolled, right? E doctor’s office or hospital CVS, Walgreens, etcetera. Uh, then the vaccine could be delivered to those locations. Um, and in theory, administered at those locations. If the state chooses that, they would rather have it go to certain on DWI will deliver to those locations. If the state chooses, they’d like toe execute a hub and spoke to ensure that they are executing their plan. Uh, we will deliver to the hubs that they designate, Uh, and if they require additional assets and, um, support from there, we’ve been talking to him about making sure they have a detailed plan, uh, with specificity and what the requirement would be and then tow. Let us know so that we can help help enable them with that. They have received funding, uh, in this light previously, which with additional funding, up to 200 million, with an additional 140 million being distributed out to the jurisdictions, uh, this month to support them in that execution. Next question. Our next question is from Rebecca Robbins. If you want to mind stating your organization, your line is open. Hello? Yes, this is Rebecca Robin from The New York Times. Thank you for taking my question. My question pertains Thio, the vaccine being developed by AstraZeneca and the University of Oxford. And I’m curious if you could tell me what the expectation is in terms of the data that will be necessary for the FDA to consider of an emergency use authorization. Uh, do you anticipate that they will need to submit data from the phase three trial in the United States? Uh, and was that the plan, and if so, how long has that defend the plan? Thank you. So first, I should say that the FDA defines what the FDA would like to see into the file on. It’s 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 ethics and safety. That data is still being digested because off the contrasted outcome that happened in regard off the immunization regiment that was used. And it’s not obvious or straightforward to come to a conclusion why there appears to have bean substantially different efficacy outcomes 90% to 62%. Andi. Frankly, unless there is a very clear explanation based on facts and data off, what’s behind those two numbers? It’s very likely that that package will not be sufficient for, um, approval. I’ll be the first one to say so I 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 will want to understand the manufacturing process and the facilities in which the clinical trial material used in the trials has bean produce and those facilities air in the UK and in Italy for the clinical trials conducted in the UK in Brazil and also for the clinical trial conducted here in the U. S. On top of that, the FDA, we want to understand and characterized the manufacturing process that’s been using here in the US at emergent by science is that by solution story that is used to produce what we call the commercial vaccine and we will need to demonstrate that that vaccine is identical technically to the vaccine used into the clinical trial. My hunch is that by the time we generate AstraZeneca, Oxford University, all this set of data, the data from the ongoing FXC trial phase three in the U. S. With the AstraZeneca vaccine will come out. That’s a fully self sufficient trial. There is no pooling. There is no geographic diversity within it. I think it’s trial that we and the FDA have overseen totally. Ultimately, it may have the largest weight in the in the decision around that I don’t 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 on potentially an 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. Um, first, I just wanted to see if you could tell us the five federal emergencies that will be getting the vaccine allotment. And secondly, just to clarify the data systems will each day be responsible for tracking the first shots and their residents and then making sure they come in for the second shot. Is there any sort of federal role in that system, or is it all of the States? So the five federal agencies are the veterans affair Department of Defense, Department of State, Indian Health Services and Bureau. Federal prisons. Uh, the second question about tracking, um, second dose is what we’ve done is we’ve set up everything from, uh, draconian process where when we sent out the ancillary kits which which have needles and syringes, we’ve included paper cards to be filled out and sent to, you know, given to the individuals reminding them off their of their next vaccine. Do they accordingly encouragement of taking a photo of it, putting it in the wallet, etcetera. Um, you know, we’re working at the draconian level. Their second states are working plans for notification. Uh, notification and information inside of state laws is very particular in some states, um, very open, and others on each state is working that plan inside of their own. Um, within all the rules and regulations on laws, we do know that, uh, pharmacies such as CVS and Walgreens have established very elaborate tracking systems. Right? Thio set up appointments, notify people when they’re second shots are required, etcetera, at the federal level. What? We’re working and we have capability and capacity. Um, thio send second, uh, those messages out on Lee if and when it’s in collaboration with states, laws and regulations and policies. Uh, eso triple canopy approach to trying to make this work on die. We’re doing our best to capture everybody to ensure that they get their second dose. Thank you. Next question. Our next question is from Emily Count. If you would mind announcing your organization, your line is open. Hi, this is Emily Cop with CQ roll call. I was hoping you could clarify how you drew the chalk line of December 15th. Was that through conversations with the FDA And is there any pressure on the FDA? Teoh, make a decision by that date. Given that Be that you’re, um I’m planning on Thanks. Okay. So, uh, you know, I’m an army general. An Army generals plan. And so literally I got up on my white board, right? And I said, Oh, they filed for you, eh? On this day. And then I got word that said, the verb pack sessions we’re gonna be on this day. So they filed ver pack was specified on. Then I said, OK, somewhere in this window right after they walked through the details is probably the earliest potential opportunity for you. A. My white board clearly speculates, only if the EU a approve would distribution begin. But we needed to dio an estimated date so we could backwards plan the requirements for distribution. For example, if we think it’s coming out on that day and we wanted 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 to the companies have to prepare the packages. Um 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 ups have to be brought into the plan for execution. And then four, of course. Um, it is, you know, the notification to the administration sites that they will receive vaccine accordingly. So, in simple terms, it is a white board plan. Uh, it is meant to help us prepare, but it is not constraining toe execution. And there is 100% without question, no interference with the FDA. And they’re very deliberate, arduous effort to make sure that we have, uh, the right solution if they if and when they do approve EU a You next question. Our next question is from Caitlin Kenney with Stars and Stripes. Your line is open. Hi. Thank you. Killing Kenny with stars and Stripes. Um, since the D. O. D. Is getting their own allocation, can you talk a little bit about what their distribution plan is among the force? Um, do they have their own priority of who gets the vaccine first? Or are they following, like, the phase one A for their health care workers and then phase one B for who they believe are essential workers. Thanks. So, just like we’re 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. Uh, and so they will figure out their plan. They’re, well, understanding. And they have the same professionals that the jurisdictions have, um, in their alignment and execution of the FDA and you a guidance as well as the 500 a sip guidance. I do not know what the Department of Defense’s plan is after that. I think we have time for two more questions on today’s briefing and again, follow up Questions can be sent to media at HHS dot gov. We’ll take two more questions. Our next question is, from whom are fun with box. Your line is open. Hi, this is a marathon of a reporter at box for Dr Slowly. You talked a little bit about the Johnson Johnson Jansen vaccine. That’s a one dose vaccine. How would that coming to fruition affect the plans for distribution? Would operation warp speed you know, shit, That’s resource is toward the one resource vaccine, Or how would that allocation proceed at that point? Well, I mean first, of course, we need to look into the performance. I should I should say that strategically, we decided with that vaccine to try one shot vaccine. But at the same time, we also decided to test it as a two shots vaccine. And that face retrial has started. Or this will cover all bases. If you wish. In terms of distribution, General Purna can command further, but there should be no difference. It z literally enter into the cadence off distributing that those except there would be no recall to the to the subject that received the first does toe come back. It’s gonna be effectively, amore efficient, faster strategy to immunize, which is particularly important in when there is a very active pandemic. And that’s the reason we wanted to assess the potential. Thank you. I’m sorry. It would be additive to the amounts that we’re sending out from Moderna and Pfizer on. Then we would do our initial push based on you and what’s available on. Then we would put them in the cadence as Dr Salah we indicated, um, in normal routine distribution accordingly. So the states and jurisdictions would then have three vaccines, um, Thio to distribute to their plan. Final question, please. The last question is from. And you’re done with business inside. And Andrew didn’t get Go ahead, sir. We can’t hear. Can’t hear anything. Somebody, somebody commute operator will go to the next question. Sure, not a problem. Our next question is from Hassam. Ahmed, with SP Your line is open. Uh, hi. Thank you for taking my question and doing this interaction. Um, can you hear me? Yes. Yeah. Eso I had a question for Dr Lori if you’ve been following at all. Um, the Russian data from, uh, with regards to the spot make vaccine, which I know they haven’t 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. Onda. Second part of the question was, um do you expect all three million nursing home residents and most health care workers to be vaccinated by the end of this year? So, regarding the first question, frankly, very scars 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 a virus similar than Virus five has bean, associate ID in HIV clinical trials with an increased susceptibility to acquiring HIV in subjects that were immunized with an HIV vaccine using that vector. So a word of caution as to exactly what kind of molecular engineering may have bean done on their vector to avoid what should obviously be avoided, which has increased its activities. According HIV, I believe it was in the male population, a za regard to the vaccination off the long term care facility residents, elderly, frail people. It’s really gonna be a decision that will be based on the recommendation from the CDC and its advisory committee on immunization practices, as well as the adherence or variance from that recommendation by the each state health agency s Oh, it’s not for us. What I can say is there will be ample amount of vaccine available to immunize three million such residents by the end of the month of December. Thank you, Dr Slowly, Thank you, General Purna. And thanks to everyone for joining, that’s all the time we have for today. Again. Please send any follow up questions to the HHS press office at media at HHS dot gov. And with that, we’ll close today’s briefing