First COVID-19 vaccines could be distributed after Dec. 10
With three promising vaccines in the works, the U.S. Department of Defense and the U.S. Department of Health and Human Services brief the community on the timeline for COVID-19 vaccine distribution.
governors. This, of course, is in addition to the almost weekly briefings that the vice president chairs with our governors, where Operation warp speed and vaccine and therapeutic distribution have been a regular topic of discussion. The past several days of seen a continuing torrent of good news around Covad 19 vaccines. On Friday, Pfizer submitted data for an emergency use authorization by the FDA, which means that we could begin distributing millions of authorized vaccines in just a few weeks. Then, yesterday morning, AstraZeneca announced promising data from its trials in the UK and Brazil through Operation Warp Speed. We have purchase agreements for up to 300 million doses of the AstraZeneca vaccine for the American people. As all of these pieces come together, we want to try to give Americans the best sense of when our most vulnerable will start receiving vaccines. As many of you know, the FDA has said it will consult with its Independent Vaccine advisory board before making a decision on emergency use authorization for a Covad 19 vaccine, and they have now scheduled a meeting for December 10th. If all goes well, we could be distributing vaccine soon after December 10th as General Purna has shared. We believe we can distribute vaccine all 64 jurisdictions within 24 hours of FDA authorization. Then we hope administration could begin as soon as the product arrives. One of the private sector partners we've enlisted, CBS Health, has said that they expect to be vaccinating residents of nursing homes, one of the top priority groups within 48 hours after FDA authorization. To ensure all of this can happen on such incredibly tight timeframes, O. W S and our partners have been running not only tabletop exercises but actual field exercises for the shipment procedures. This week, for instance, we will be making test shipments with the ordering system that states will use that is, performing shipments that don't contain actual product in order to ensure that all goes smoothly. These are the kinds of procedures you put in place to ensure a seamless logistical operation. And we're so grateful for the expertise that the U. S military on our private partners have brought to this task well, much of our briefing today is focused on vaccines. I want to note that Operation warp speed continues to charge ahead on therapeutics and our therapeutic options continue to expand. We have already distributed more than 120,000 courses of Eli Lilly's monoclonal antibody treatment through state health departments to more than 2400 treatment sites across America. We've allocated another 50,000 courses which will ship this week. Then following FDA is authorization of Regeneron's antibody cocktail. This past weekend, we began distribution of the 1st 35,000 doses of that product today. This means we have two new options for Americans who aren't hospitalized with Cove in 19 but are at risk of progressing to severe disease. I encourage everyone to spread the word. If you test positive for Covad 19 and are over 65 or have underlying conditions that put you at high risk for severe disease, you may have access to a treatment that can help you, and you should get in touch with your health care provider or state health department. Toward the end of last week, FDA also granted an emergency use authorization for the use of Beira City nib on anti inflammatory drug in conjunction with Romney severe for hospitalized patients. This was based on results from the act to trial coordinated with Operation Warp Speed, which found that there was a statistically significant reduction in hospital stay for that drug combination versus Romney. Severe alone. This is a product that is already widely available in the United States. Over 250,000 people have received convalescent plasma. It's critical that we keep our supplies up to meet demand. Please ask your viewers, readers and listeners if they are within three months of recovery from CO vid 19. Please consider giving the gift of life this holiday season. Go to coronavirus dot gov. The fight is in us or gig. Contact your local American Red Cross or your local American blood center to be a donor. All of this good news should encourage all of us to continue keeping ourselves, our families and our communities safe. Remember the three W's. Wash your hands, watch your distance where your face coverings when you can't watch your distance and avoid settings where you can't do those things with Thanksgiving This week, I encourage Americans to consult CDCs recommendations and guidelines to understand the risks around gatherings and how you can reduce those risks. I know that the possibility of not being able to see family and friends over the holiday is heartbreaking for all of us. But because of the president's support of operation warp speed, because of the incredible work of the U. S. Military, public servants at every level of government and the brilliance of American scientists, we have an end in sight and we have much happier holidays in the near future. The American people can be confident that hope and help are on the way. With that, I'll hand things over to Dr Moncef Slowey to discuss updates on vaccine development. Dr. Sloppy. Thank you, Mr Secretary. Maybe maybe just a few words very quickly with Don't answer your questions. After also, the General Purna gives you an update. A few words about the AstraZeneca face retrial Things have been very interesting and encouraging data. The fact that one part of the trial has demonstrated 90% efficacy further reinforces the observations with Pfizer on Moderna vaccines that this virus can be very, very strongly protected against. And I think that's very important for everybody to understand and hopefully will help the majority of the US population too. Stay with an open mind in terms of accepting to be vaccinated. Stay to listen to all the data that will be shared transparently through the FDA reviews with its advisory committee off the fighter vaccine. As Mr Secretary said on December 10th and off the Moderna vaccine, more or less a week later on, hopefully is vaccines will become available. The AstraZeneca, faced with right, had also more intriguing data in that a certain particular schedule off immunization in terms of those that has yielded an efficacy that was somewhat less 62%. And when the two combined together, a knave ridge of about 70% protection has bean achieved. These observations and data were generated from clinical trials run in the UK and in Brazil. We have a face retrial running here in the U. S. It has already recruited more than 11,000 subjects into it. Unfortunately, the pandemic in the U. S. Is progressing so fast that it is very likely that this trial, not long from now, may have enough evidence generated within it to assess the efficacy off the vaccines as administered here. We are, of course, also reviewing in depth with the AstraZeneca, an Oxford team's ALS. The specifics of the data generated to understand what difference there is between the schedule that gives the 62% efficacy and one that gives 90% efficacy. On the therapeutic side, I'd like to also add one element of information to the information that Mr Secretary gave, which is a new important one, I think, in the sense that Merck, large U. S pharmaceutical company has acquired a small biotech company called Anca Immune that we have identified about 78 weeks ago as holding data with a particular program in their portfolio that are really impressive in that in the interim analysis of their face streets. While that was ongoing, they had over 50% relative reduction in the risk of mortality in patients that had severe hospitalized but not yet intubated condition with covered 19. This acquisition is something that we have participated to make happen in connecting the company, the small company that has 10 10 people working in it with Merck as a mean to help accelerate the development off this therapeutic important therapeutic for us patients on. Finally, the last point I'd like to make is to invite as many volunteers as possible to please come and participate into the vaccine trials if you are healthy and particularly if you correspond to the at risk populations over the age of 65 with calmer abilities or if you are parts off the rich, diversity off populations in the United States, it is through your generous participation in clinical trials that we are able to generate and understand the performance of our vaccines and help us make them available faster and better for all of you. Thank you. I'll pass on now to General Purna for a brief update. Thanks, Dr Slowly. And of course, Mr Secretary, Thanks for the opportunity to be part of this. So good morning, everybody, um, want to say thanks for participation, Aziz. Both my secretary and Dr Slowly said, It's really just important that we're able to get the message out on a routine basis. So thank you for that. Last week I talked about our distribution in our method just a za recap. You know, we chose a whole of America approach in distribution for two reasons. One we wanted the experts who know how to do this, uh, to help us plan and be a part of it to ensure that we had the right capability and capacity. So from Pfizer, Madonna, McKesson trucking through FedEx ups, uh, down to the pharmacy such as CVS and Walgreens, Uh, and many others. The intent was to integrate, synchronized and capitalize on known professionals who know how to execute this. Our cornerstone is the CDC. These experts know how to distribute vaccines. They do it annually on. We were able to take all their lessons learned over the years and apply them into the plan. Second reason we chose this whole of America approach is we wanted the American people toe have confidence in the process, uh, not to be afraid of or enamored by all the grandiose schemes, but yet just know that the common names of America are distributing the vaccine to them and that when they have the vaccine administered, it will be in locations that they're comfortable with. Local hospitals, doctors offices, local pharmacies such as CVS and Walgreens or private pharmacies supporting rural areas areas. So again, it was about making sure we have the capability and capacity and to giving the American people the confidence that the vaccine will be delivered in a timely and routine manner. So today. With that set, I'd like to talk about three things. One our allocation strategy to the Pfizer testing that they've been doing and moving their product around the nation in their containers and then three. How are we actually managing ultra cold storage? I think three points. The highlight that would help you see the specificity of the things we're doing. So first allocation numbers went to the 64 jurisdictions and five federal agencies last Friday, in fact, that we hit the button at 11 35 PM or 23 35 military time. And that information went out to all the jurisdictions and five agencies through Tiberius each received their allocation of the vaccine so that they can plan on figure out where they want the vaccine to be distributed to. As a reminder, we are able to distribute the vaccine to any location in any jurisdiction that has been enrolled as a provider. We're not constrained by numbers. It could be one. It could be 1000 or beyond a zoo, long as they are a enrolled provider on the state approves them. Uh, and they have the minimum requirement of the vaccine, which is 975 doses by Pfizer and 100 doses by Madonna. We collectively, with this whole of America approach, can deliver anywhere in America to that end. Second, we have maintained a minimum safety stock, but on Lee to assess the initial distribution of the vaccine to ensure that all everybody understands the process, understands the clarity of requirements for ultra cold storage on understands how to utilize and administer of the vaccine. But once we're confident that that the jurisdictions air confident, then we will release the safety stock to ensure maximum use in the country we have provided. And we're working with each of administration or jurisdictions right now methods to plan on, then figure out allocation within the States through the system we call Tiberius. We have been working with the jurisdictions for quite some time now, partnered at the 500 level on how to run Scenarios toe actually determine where they put their allocation of vaccine, uh, to the best advantage in following f d a. You A guidance as well as C. D. C uh, a sip guidance this way that the leadership of the state has a maximum capability and capacity to plan, look through different scenarios and then make a final decision to best impact the people of the United States. Really powerful system toe. Help us lead our way through execution and not react. We will be sending, um after we send the initial push of the vaccine here a pendant, eu a. Then we'll be on a steady drumbeat of sending allocations to the jurisdictions every week. Right? We'll allocate vaccines. Jurisdictions will be allowed Thio go in 24 7 and order and distribute the vaccine to where they want it on. Then the following day, we'll be able to get it to the locations that they designate really hard work Great collaboration with both HHS Department of Defense and Industry to get this right. But I'm very, very confident that we have a solid plan and that we have the ability to to observe, watch, monitor, adjust, uh, to meet the requirements, um, has been specified through the through the states. So very difficult challenge. We're working on this constantly. We work rehearsals of different, um uh, scenarios to make sure we're capturing all the nuances of the delivery. But each and every week we get stronger. It's It's not lost. Anybody listening where One week closer to distributing the vaccine, where one week closer to refining to the exactness that we need tohave to do this on a very confident in that process. So the second thing I'd like to talk to you about is the Pfizer initiated tests. Really remarkable. You know, we do this all the time in the Department of Defense. It's one of our strengths. We know how to plan. We know how to rehearse. Uh, I was equally excited. Toe watch. Pfizer and Madonna go through similar processes to make sure that their product is right to begin with. But most importantly, we can get it where it needs to be when it's time, uh, to get it out to the American people. Pfizer is really implementing a very aggressive approach to figuring out how to get their product out to the administration sites as designated by the states. They're running dry rehearsals. Aziz. We like to call it in d o d. This way they run through the actual process of registering product through a jurisdiction. Uh, then they deliver the product. Then they walked the administration sites through the actual opening on. How do they manage the product out of the container? Really powerful to watch and see people learning. Uh, Pfizer is capturing lessons learned, and they're putting it in training product back sheets. Azaz. Well, as creating YouTube like videos for everybody to observe and monitor. We started small at four locations. We recently expanded the 10 locations. Uh, we're going to go to the remaining 54 locations, uh, to ensure that everybody has an understanding of this. What we have found in general is initial hesitation once the product is received. But as Pfizer has walked three administration sites through the execution, we see growing confidence in everybody that's using it. Uh, and that has been the story throughout every, uh, rehearsal so far again, we have to walk through everybody to make sure everybody is confident in it. But I think I personally have gone through the process I've managed. I've actually put my hands in the box. I pulled trays out, I've watched and I've timed myself in execution. Uh, it is a very, very doable process. Are professionals both medical attn medical level and then at the pharmacy level, are very well versed on how to do this. It is not the first time on I feel the confidence in the reinforcement through our rehearsals, our training products and then actual execution will create a steady level of confidence for the final, full and complete administration of the vaccine so well done by Pfizer on Madonna getting ready to do summer acts accordingly. So last but not least, it is about the ultra cold storage of the vaccine. We've all heard Pfizer vaccine has a requirement of 8 80 minus 80 degrees, right at ultra cold storage. This freezer is, uh, important, but not to a limiting limiting end. In other words, Pfizer has created a container which is augmented with dry ice that maintains the vaccine at the appropriate level. Uh, in doing so, they have enabled the extension of vaccine storage at the rights to maintain the right stability for up to 20 days, really a tremendous effort, as I just described in the training that they're doing to ensure that the vaccine is available on stable and appropriate for administration. Uh, and we feel confident that if states plan to the right dosage at the right locations, that the drumbeat, the Cadence Thea administration of vaccine to the minimum amount, which is 975 doses, is very doable within the 20 days. Uh, clearly, we have to have a plan. Clearly, we have to hold ourselves accountable to administering that. But it is a plan that could be done on. We feel confident in talking with the jurisdictions that they've worked through these details, uh, to ensure that the vaccine is used appropriately on without any waste, which is the biggest important factor for us. So a challenge, Yes. But it should not hold us back from administering a very good vaccine to the American people. Madonna eyes a different case there. At minus 20 degrees, uh, minus 20 degrees is equivalent to a normal kitchen, uh, refrigerator, freezer or a freezer that is most commonly found in most pharmacies, etcetera. It has greater stability and that it could go into the refrigeration for up to 30 days. Yes, So it becomes a vaccine that its administration becomes easier to do on. It will enable us to get to many places throughout the country, as we've talked about before, from inner city, out to rural America. It produces an advantage to that end. But I will tell you that I believe the jurisdictions already, they've been well informed on the information of both vaccines. Both requirements for cold chain storage. They have, uh, added capability and capacity as required. They have trained people to administer it. Uh, they have contacted pharmacies for support. Like Walgreens and CVS toe. Help them on. We're well on our way to successfully administering both vaccines to the American people in the near future. So, Mr Secretary, that concludes my comments. Thank you, general. And at this point, we'll take questions from the media, a reminder that this call is recorded. If you would like to ask a question, please press star one from your phone, a new airline and speak your name clearly when prompted. Your name is needed to introduce the question. Please limit to one question so we can try to address all questions today. If you would like to withdraw your question, please press star to again. If you would like to ask a question, please Press star 11 moment, please. As we wait for any questions, our first question will come from Helen brands Ball. How in your line is open. Thanks very much. Um, this is probably a dumb question, but can you talk us through the logistics of how this will work? Um, how many? You know? Ah, hospital in, Say, uh, Reno get, uh, 995 doses of the sizer vaccine. Are they meant to then try to vaccinate 995 healthcare workers as quickly as they can? Or they're supposed to reserve half of that trash so that they can give that group of people their second vaccine later? It's not. How does it? How can they be assured that they're going to be in the right place in the line to get the second dose when those people need their second dose? Okay, so, uh, what what we're working with is the states have really worked there. Micro plants on the final distribution on That's what they're actually putting into place over the next two weeks in preparation for EU A and their specified and they identified, uh, amounts of providers, providers could be everywhere from local hospitals, doctor's offices, pharmacies, etcetera, a song as their enroll. We can distribute to them in their plans and with their identified priorities, they will specify how they want to administer the vaccine. So in your example, let's say one tray from Pfizer Vaccine goes to a hospital. It has 975 doses in the tray. Viles could be taken out of the tray right every single day and brought down to room temperature for ministered. It's not a requirement to do all 119 7900 and 75. And one day or one week they have, as I talked about up to 20 days to really administer those 975 doses to ensure that they can get the right people in the right places at the right time. Currently, right now, our plan is to initially distribute the first dose vaccines to the states and then on a second delivery at 21 days for Pfizer and 28 days for Moderna. The states will receive the vaccine for the second dose. There is methods from, uh, very simple. Here's your card. Come back on this day for your second dose to very elaborate automated plans at both the state and national level to ensure reminders are sent, uh, in the vaccine is available for the persons. We are continually to assess the manufacturing of the vaccine on. We think that once we have a really steady, confident cadence and manufacturing in the very near future, there is potential to just, um, vaccinate at maximum allocation because we have confidence that the second dose will be available accordingly. Uh, we're just the starting this way initially to ensure that everybody understands the process on we can be accounted for. Thank you. Next question, please. The next question is from Zach Brennan political questions a little bit about the timing with a sip recommendation after a possible u A. They'd be able to adjust where the first round of doses will go based on the ace of recommendations, even if you're shipping within 24 hours after the u. A. So Zach, I think it's important to understand the nature of a C. I. P s role. This is for for other members of the media. This is the Advisory Committee on Immunization Practices, which is an advisory committee uh, set up under statute that's used by CDC connected, especially usually the vaccine for Children's program. Uh, the pipe has, of course a very important role in that, Uh, when they make a recommendation for a group to be vaccinated that they say essentially, that the efficacy outweighs safety risk for vaccination and they recommend vaccination that triggers various reimbursement mechanisms in our system. Once there's an A C I p. Recommendation, Um, as we have with the National Academies of Science, we've worked with the Advisory Committee on Immunization Practices. Uh, in addition to their statutory obligation on that binary recommendation to vaccinate. We've also sought any insight, input, etcetera around when dealing with a scarce quantity vaccine which groups which which cohorts to prioritize at the end of the day. That is a decision, though, of the U. S. Government to make, which is where to recommend the prioritization and in the final, say it will be our nation's governors and implementing the distribution plans to tell us. As General Purna has repeatedly said where to ship and they will decide whom the vaccine is given. Thio. We hope that our recommendations will carry weight with them, but at the end of the day, they will make that decision and so we are not dependent on any delay for a Skype in terms of helping to advise states on that prioritization. We received some information just yesterday from a Skype. We had received the National Academies input previously, which is still going through some public comment with them. But we will work. We're working expeditiously to formulate our recommended prioritization for vaccine distribution based on where we can secure the maximum effect under whatever the current epidemiological circumstances are in the United States at that time. Thank you. Next question, please. The next question is from John Cone. John, your line is open so much. Um, the company has been less than transparent about how the half half does occurred. And I'm wondering whether they explain to you what happened and also whether you have plans to switch toe half does as the prime for the AstraZeneca hawks for right? Yes. So we have been made aware off the what school Now, the half those at the time it has happened this waas a change in the way the quantity of vaccine, the amount of vaccine put in a vile waas tested and when they when they realized that there was an error or change in the approach technique used. They corrected it and in the meantime, about 3000 subjects who are recruited half of them in the placebo and half of them in the vaccine group. And that's the cohort that has shown 90% efficacy. That's I would say, the fact in terms of what has been inputted into the vaccine ease. What we are now looking to analyze is what immune response has been induced in Those who have received have those and the full does versus those that have received twice the full does and understand whether there are differences in the immune response and used. You should also know that there are also differences in the age brackets present in the cohorts in that the first cohort that received they have those and full does, followed by a full does, had a cap on the age at the age of 55 when there are older people included in the city that received full does and full does. So there are number of variables that we need to understand and what what has been the role of each one of them in achieving the difference in efficacy. Once we understand, then we'll make a decision as to whether to, for instance, modify in part the ongoing face retrial here and introduce, for instance, have those and full does or any otherwise. But we wanted to be based on data and science because we understand the input. But we don't understand the consequences of the input. I should just say for completeness, scientifically, that the 90% Efficacy Group and the 62% Efficacy group are overlapping statistically. So it is still possible that that difference is a random difference. It's unlikely, but it's still possible. It's a random difference. We need to understand what's behind it. Scientifically. Thank you. Next question. The next question is from Carlo Don. Oh, Carl, your line is open. Hi, this is Carla Donald from Reuters. You mentioned that you had given some guidance to the the States in terms of the general size of the initial allocation vaccine that they're going to get to help them prepare. Do you have a national figure at this point for the amount of vaccine, you know, that that will be distributed overall to the different states and jurisdictions on. But what What is that figure And are you confident that will still get to the 40 million figure overall by the end of the year? So, yes, I do feel confident that we're going to get too close, close as we can, the 40 million at the end of the year. I mean, it's not the chalk line. What exactly comes off? We'll know at the end. But I do feel confident, and we've planned scenarios to that end. And we've worked with the jurisdictions for the total amount through December, the initial amount Aziz we were speculating on when you would a would come out because we're not involved in that process, literally on the white board. We're trying to figure out when that decision might be made. I finally made the decision Friday night late Friday night to snap the chalk line. Eso states could prioritize based on amount. That amount that we allocated to the country was 6.4 million doses of vaccine. Uh, and then what will happen if, uh, if there's mawr available after the initial push, then it will go out in the following Kate weekly cadences of distribution accordingly, but yes, 40 million by the end of the year. Next question, please. Next question is that the Amber Gano buzzfeed news? Thanks very much. Uh, I'm wondering if you have any concern that the general population will be disappointed when they figure out the prioritization is going on That is going to health care workers, uh, nursing homes, that sort of thing and not sort of the general public until it sounds like a month from now on. Um, months have been discussed like April to June Thereabouts. If you have any guidance on that as well, that would be great. Thanks very much. Well, uh, Dan, we've been very transparent throughout for the American people and for you all about the timelines, as we best understand them at each step of the way and potential prioritized groups. Of course, we have not announced recommended prioritization. We've talked about some core groups that makes, um, fairly obvious sense, Especially in light of the National Academies. Uh, input and the advisory committee on immunization practices focus. Uh, those, of course, are those in nursing homes. As you mentioned, our most vulnerable citizens are health care workers who are on the front lines Are first responders those air, some of the broad groups we've talked about, and we focused. And we've said that we expect by the end of December, toe have enough vaccine to vaccinate those who are most vulnerable just by way of sizing and scaling that by the end of January, we think we would have enough to vaccinate our senior citizens as well as our health care workers and first responders. And then, as the general has talked about progressively week after week, just more vaccine keeps coming off of the production, gets quality controlled and released into the system additional prioritized groups or eventually, just general vaccination availability to the point that in the second quarter of next year we believe we have enough vaccine from all sources to be able Thio make that so that anyone who wanted to get a vaccine in the United States would be able to get that. But that's a progression, a constant progression. And and so we've been very clear for months really about about that sequence and that's that's the best we can do is just to use forums like these and others to educate in that regard. We have time for three more questions. The next question comes from Tom. How? Washington Times. I, uh thanks for doing the call. Uh, this question is probably for the secretary. Earlier in the year, there were some polls this showed, um some people were leery of taking a vaccine, so that was tied toe campaign timelines. Now that the election is over, and now, that's, um, data's coming in that shows these shots are quite effective. How confident are you that people will be eager to go take up the vaccine? Um, And what are you doing to ensure, um, to alleviate any skepticism, Especially among minority populations. Thank you. Yeah. Thank you very much, Tom. Excellent question. You're right. We saw ever increasing, uh, numbers of potential vaccine hesitancy in previous months. Unfortunately, there was a lot of rhetoric out there that was not helpful. Uh, in terms of inspiring confidence in the process, the president and I have been clear that politics would play no role in the development, the manufacturer, the distribution or approval of a vaccine. I think the proof is in the pudding there that we now that we have all of these various checks on independence in the system. I've talked about five separate checks. The Data and Safety Monitoring Board that determines even if the drug company gets to see data. The drug companies own ethical checks, where they determine if they even find the data to meet their ethical standards to submit for approval. The fact that the FDA has laid out both final biologic license as well as you a guidance on what standards they would hold a vaccine applicant, uh, to the fact that, uh, the FDA would hold a public advisory process with their vaccine advisory committee. Uh, that is an independent, transparent public process. They've already announced on Friday that December 10th will be the date for the Pfizer Advisory Committee. And then, finally, the fact that FDA career scientists, career leaders will make the ultimate call on whether a vaccine meets FDA is data, scientific, evidentiary and legal standards for authorization or eventual approval. Uh, we have seen, since the fighter and Madonna data have come out with such exceptional results on, of course, with the passing of the election, we have seen in public polling increases in vaccine acceptance among them among people, we obviously remain concerned, especially in various underserved communities, about any issues of vaccine hesitancy. The C D. C R CIST sector for public affairs, as well as all of our public health leaders were working on a public service announcement campaign that would work to educate the broad population regarding, uh, the need to be vaccinated. The safety of the vaccine, the efficacy of the vaccine theme. Porton of getting vaccinated. If you're in one of the target prioritized groups on, we'll just keep. We'll keep doing that. And I think progressively as more and more people get vaccinated over time, the prioritized groups moving forward eventually to general vaccination. Hopefully, there's a positive experience for individuals and that by word of mouth, in addition, of course, to all of the education efforts, uh, we continue to reduce vaccine hesitancy and continue to increase support among people to get vaccinated. Uh, I've told you, uh, I certainly, uh, will will have complete confidence in the process, Andi. I will get myself vaccinated as soon as I will be allowed to be vaccinated to demonstrate to the American people my complete confidence in the independence and integrity of the process and the quality of any vaccine that I would make available to the American people. Next question. The next question from Andrew Done Business insider. Andrew, you may begin. Thank you. I was wondering what do you see as the to put it, simply the ultimate responsibility of state in the distribution process. Um, can you go over clearly what jurisdictional public health leaders will need to do as part of the campaign? And have you heard from many states of regions about the need for additional funding to actually make that happen at the state level? Yeah, thanks. I'll start in the last general permanent toe. Add to it. Eso uh this is obviously as we talked about in our last call this is there two types of partnerships here that are involved? The first is the public private partnership of what we're trying to do to really leverage the systems around vaccine distribution. United States that are well rehearsed and at work. We want to make the experience for people as close to the flu vaccination experience as possible in terms of meeting them where they are. The second is a federal state partnership. Very tight linkage between us. We have gotten the vaccine we're paying for the vaccine. We are paying for the distribution of the vaccine. We have secured the kits that go with vaccination. That's the needles, the syringes, the deal. You want the last mile dry ice, etcetera to marry that up with the vaccine. Uh, we have the data systems for distributing the vaccine as well as for accounting for the immunization of individuals. The tracking of individuals to ensure they get a second dose of the same vaccine. What is the role of the states? Of course, the governors will determine distribution within their states. Prioritization within their states where to ship to. As the general has said, we can ship toe one site or 1000 sites in a state, depending on the governor's. Long is they're enrolled in the system, and the governor tells us what he or she would like us to dio Uh, that's one. Tell us as almost an air traffic controller, where would you like us to send or have sent the product? The second is ensure your data systems are working with ours and that you've signed out a use agreements to ensure the transit the ability of coordination of information across the United States. so that if somebody gets vaccinated with the first dose in New York and they then go down to Florida for the rest of the winter, they could get their second dose in Florida. And if it was, Pfizer remains fighter was Madonna. It remains Madonna. The states will obviously, if there are additional areas that they would like to ensure distribution to be on the normal traditional mechanisms that we've worked on. Hospitals, chain drugstores, community pharmacies, uh, community health centers, public health departments. If governors feel there's a need for customized other approaches, they are fully at liberty to set those up. Um, that is, that is, that is part of them being in the driver's seat on that localized micro distribution planning. We've put out $340 million for flu and pen and co. Vid 19 vaccination to date, another 140 million is going out in December. Uh, money should not be the barrier to effective, efficient distribution of the product working with states, but it is important to remember just how much of this entire process is already federally funded and federally supported in partnership with the state's general. Mr Secretary, I am 100% agreement and everything you said and have nothing to add. Thank you, General. One last question, I believe Michael. Thank you. The next question is from Jared Hopkins. Jared, your line is open. Thanks. Uh, Jared Hopkins from the Wall Street Journal. Uh, regarding allocation I Previously the CDC said that besides population local spread of cove, it was gonna be a factor for determining for each state. So can you explain sort of how you guys decided on each state's individual allocations within that six million that that you mentioned earlier? Is it based on infection rates from Friday or something else? Yeah. So? So, Jared, you know, given the national spread of the disease at this point and unfortunately for the foreseeable future, working and seeking consultation with the governor's, we asked the governor's for input on allocation methodology. We didn't receive feedback from many, but the feedback we did get was supportive of what we proposed, which was to keep this simple and on the initial allocations to follow a per capita over the age of 18 population based formula for for trying for distributing the vaccine. We wanted to keep this simple first because we're seeing effectively nation wide spread and susceptibility to the disease. But also, once we pass through these initial tranches, where we're in much more of a scarcity situation, we're eventually going to get to the point where it would need to be per capita. And so instead of having multiple methodologies, we thought it best to keep it simple. The governor supported that from the feedback that we received. That was the approach we took exactly right, Mr Secretary? Um, so we just we thought that would be the fairest approach. The most consistent. Um, I want to thank you all for this. We're gonna keep doing this weekly or as much as needed. We wanna make sure that you're getting your questions answered that were being transparent about our operation warp speed work on therapeutics, on vaccines, on distribution practices. I was not asked about this, but I do wanna let you know that consistent with the NSA administrators ascertainment yesterday, uh, last night, our top career official, Rear Admiral Schwartz, who has been leading our transition planning efforts, was last night, uh, in communication with the Biden transition team. We are immediately getting them all of the pre prepared transition briefing materials. We will ensure coordinated briefings with them to ensure they're getting whatever information that they feel they need. That's consistent with statute and past practice. Uh, I have reiterated I've said Pause. I've said publicly to you all I've reiterated Admiral Shorts. Uh, my firm commitment that transition, planning and execution will be professional, cooperative and collaborative in the best spirit of looking out for the health and well being of the American people and in particular, saving lives through this cove in 19 Pandemic, I want to say again, just thanks to the support, unwavering and constant and personal support that this team has had from President Trump from the beginning to create operation warp speed to give us the full funding of resources and the independence to act with speed and agility, we now have phase three data on three vaccines. Three more vaccines in active study. Five therapeutics now are authorized or approved by the FDA to help people suffering from Kobe. So much is already here. So much is on the way. As I say, hope and help are on the way. But that also means we're bridging right now. we're bridging toe when we have these vaccines that General Purna is going to ensure are getting out there to our most vulnerable into our health care workers and our first responders and eventually the broad American population. It means we need to bridge through our individual behaviors. We wanna make sure that everybody can get to the day of experiencing the benefits of the work that that team is delivering. And that means wash your hands. Watch your distance where your face coverings when you can't watch your distance. Stay on the settings where you can't do those things. Be especially mindful of indoor gatherings, especially those where you might let your guard down like household gatherings, overcrowded indoor restaurants, indoor bars. Especially now, as we approach Thanksgiving, I ask all Americans, please be on guard. Take care of ourselves. Be careful because there is such a bright day ahead with what this team is delivering on vaccines and therapeutics. We want to make sure that everybody is here for next year's Thanksgiving, so thank you all very much and members of the media, thank you for helping us in our efforts to ensure the American people go on this journey with us. Thank you. Thank you all. You can send any follow up questions to our press office at media at HHS dot gov. Thank you all for joining today's briefing. Oh.