Every day. And waiting two or four more months, we count into the tens of thousands of more deaths. A harm to the population, that no vaccine ever would even approach in decades or centuries. So, we believe that these vaccines will have their safety and their efficacy very well documented to the point we are today. We really look forward to the reviews with the fda who are independently with its vaccine review board, potentially approve these vaccines and the cdc and acip as the secretary said, would recommend. Then we look forward to the next two vaccines that we hope will be giving us data on their efficacy, in weeks to come. Maybe in early january for one of them. And for the other, it could be in the next few weeks, if data from trials running outside of the u. S. , or maybe slightly later with trials in the u. S. Read out. Thank you very much. I will pass to the coleader of me with the operations. Mr. Secretary, dr. Solari, my coleader, thank you for this opportunity to talk about and focus a little bit on distribution. So, first, i just will say this is it is a large task. But its a task that we are up for. And were going to take a whole of america approach. Thats why were going to be able to do this. And weve been working on this now for over six months. Since the announcement six months ago on may 15th, we literally started planning accordingly. And it is the foundation of our planning started with the great experts at the cdc. And its been extended to the jurisdiction planners so that we have a great collaborative plan on how to execute this together. All right. And as the secretary talked about earlier, we have implemented several mechanisms to allow other organizations inside of america to enable execution, not one source or one organization will be responsible, but its the collective group of us that will make this successful. So, distribution of the vaccine will be based on fair and equitable availability of the vaccine, rata to the population. In other words, the vaccine will be distributed to each state. We have been working these numbers with the states for a little while. And every week that goes by, we are able to create a tighter shock group of the actual numbers and allocations that will be available to each state, as we get going. Distribution will be by jurisdiction, as i talked about, i use jurisdiction and states, you know, sometimes, inappropriately. So, let me define jurisdictions, 64 of them. 50 states. 8 territories and 6 metropolitan cities equal the 64 jurisdictions. Were doing extensive planning with each of these organizations so that we implement their plan. All right. So, they will figure out where we want the vaccine to be distributed to, and administered. And thats where the vaccine will be distributed accordingly. So, we want to emphasize following, of course, the fda guidelines, cdc, acip guidelines. The governors and the states will figure out the plan. And we are ready to execute in collaboration with their plan, as weve been working on for six months. Doing numerous tabletop exercises. And now extending it into actual rehearsals of how to move the product from fill finish sites to Distribution Centers down to Actual Administration sites. We are making sure, as i said, that its a whole of america approach. So, let me pull the string on that a little bit for you. So, clearly, here in health and human services, the cdc, the cornerstone, are experts that know how to distribute vaccine as they do every year annually for influenza, as theyve done for h1n1, et cetera. A very talented group of people who know all of the technical aspects and all of the requirements that are needed to make sure that the vaccine, once we have it fill finished, we can distribute in a safe and effective way. The second step, as i mentioned earlier is 100 collaboration with the jurisdictions. Making sure that we are integrated and synchronized and ready to implement their plan for the way they want to execute immunization down at the administration sites, agency they define it. And were ready to do that, because weve been working together for quite a while. Cdc published a playbook back in september, and the jurisdictions have been going through the playbook, filling it out. Weve been collaborating and weve been working the plan and nuances to make sure every detail is covered. Second, we are working with commercial industry. The experts in this field. Those that know how to produce, store, distribute and administer the vaccine accordingly. They do this every day. This is the United States of america. This is not new to us. And so, organizations, of course, starting with pfizer and moderna, right . Who know how to produce, fill finish, and then begin distribution of the vaccine, right, its their core competency. Then were working with mckesson, a large, very large Distribution Company that knows how to produce, or distribute vaccine throughout the entire country. And ill talk about that in a minute. And then as the secretary mentioned, we have collaborated with pharma, such as cvs and walgreens. All right. So that we have already laid out plans and coordinated memorandums of agreement to ensure that were executing the right way, in accordance with the jurisdiction plans. As they direct well execute. So, were bringing this whole of america approach from government to industry. And were bringing it all together to ensure that safe and effective vaccines are delivered to the American People in a timely manner. The Time Associated with delivery. We will begin distribution of the vaccine within 24 hours after emergency use authorization is approved. All right. And only after the science has determined and approved it accordingly, then we are poised and ready to begin distribution. Distribution will occur from our fill finish sites. And well go to all 64 jurisdictions that we are responsible to ensure that they get vaccine for, within 24 hours. So, everybody, every jurisdiction, will have access immediately. Upon the initial push of vaccine which is the quantities of vaccines that are Available Upon the emergency use authorization, then we will begin a weekly cadence of delivery of vaccine. As vaccine comes off the shelf, as its been approved and available for distribution, we will distribute it to 64 jurisdictions. So, initial push, and then a continuous cadence of delivery of vaccine to ensure that we rapidly expand the availability to the entire country simultaneously. We are working with jurisdictions to do several things, though that we need to make sure that we get done as we get closer to final approval at the eua by the fda. Three things that were working with the jurisdictions that we need to have, first, we must have jurisdictions create good, solid, expansive provider enrollment. All right. As Many Organizations as they want, need to be enrolled, so that we can expand distribution rapidly to the quantities of vaccine thats available. Only to providers that are enrolled can we distribute to. So, they can limit it to a certain amount, or they can expand it so we can ensure that were covering the entire country as the secretary alluded to in his comments. Very key point. We have made significant progress in this area. We are just counting the aegis of provider enrollments that we need to get done as we get closer and closer to final distribution day. Second, we must have the states go through and sign their data use agreements. This is incredibly important, right, for the new vaccine going out to the American People. First, we must be able to see who got their first dose. Where they got their first dose, and what vaccine did they receive as their first dose. Why . Because we must ensure that we can do the same for the second dose of each vaccine that were sending out. The second thing, and really important is we want to make sure that we have a good, consistent flow of vaccine out to the American People. And so, our ability to track the uptake, the Actual Administration of the shot in an arm is going to be essential to us, making sure we deliver vaccine on a continuous basis. So, really, important. The third thing i would keep jurisdictions working on is their actual rehearsals in the execution of the plan. We conduct tabletop exercises at this level, right where all of government and industry and jurisdictions participate. But then were expanding it now to actual execution down at the tactical level, or down in the local cities. How do we work distribution of vaccine through the cvs, walgreens, et cetera, at the hospital . How does it actually get received, unloaded, stored and then administered. As the rehearsals were working. I continually emphasize this with jurisdictions. It is a great mechanism to check and doublecheck to make sure everything is in place. What were doing to make sure that we are ready at this level, after working these details for the last six months, as i told the team, two things we must have. One, upon emergency use authorization, all of america must receive vaccine within 24 hours, as i said. I think this is incredibly important. Fair and equitable distribution of the vaccine throughout the country, simultaneously, there is no haves and have nots. It is an equitable distribution. And we are driving hard to make sure that happens. The second thing that we want to do is make sure that the cadence of vaccine delivery following the first push is routine, so that states jurisdictions can plan for it, and account and develop execution of the administration in a routine method, so that the population is well informed. And that they know where to get the vaccine and when to get the vaccine and so, those two points were driving home agency ks ke essential tasks at our level. Mr. Secretary, thank you. I pause. As we get ready for questions, i just want to conclude the opening by expressing my deem appreciate to the doctor and general perna. I called are around to people in the industry on vaccines, everybody said the person you need leading this is solawi, the man with the track record and hes proven it that. I met with the secretaries of joint chiefs and they immediately said, the person you need leading this effort is general gus perna. The American Public are in deep, deep gratitude to these two individuals, as well as the hundreds of people on their teams, delivering the kinds of results, historic results weve seen in the last week. So, well turn now to questions. Thank you, operator, we can now open it up for questions. Thank you. At this time, if you would like to ask a question, you may press star 1. Please unmute your offense and state your first and last name unprompted. To withdraw your question, you may press star 2. One moment for the first question. Zachary brennan, you may go ahead and please state your outlet. Thanks for taking the question, im with politico. Im curious if someone can talk about federal plans for vaccine waste. If youre trying to vaccinate a hospital with 37 doctors and the Pfizer Vaccine only comes in five doses per vial. And 195 vials per container. What is the plan for the remaining doses that might be left over . Let me ask general perna. Thank you. Really an important question, and weve been working hard with the jurisdictions to make sure that the plan provides the details to that end. So, you mentioned it. Pfizer comes at a minimum package of 975 doses per tray. And moderna comes in at 100 doses per tray. With that said, though that only a constrain because of what we have to do to maintain it at the right temperature for stability. So, you can break down both vaccines, all right. You can pull out quantities of what you want to execute and put them reduce them and put them into a normal refrigeration and execute them within five days. Thats the key. So, its the planning, the specified execution that were counting on. And the states have been working this. One of the reasons that we asked and we brought walgreens and cvs special as the secretary mentioned is because they know how to break this down and do small quantities for important groups. And so, weve worked very detailed plans with them. And were collaborating that with the jurisdictions to make sure that no vaccine is wasted and that when they go to immunize at specified places, they have the right techniques and procedures to make sure that only the required doses are reduced to the right temperature for administration and that the others stay in the appropriate temperature for stability. Thank you. Next question. Thank you, next question comes from evan brown. You may go ahead and please state your outlet. Good afternoon, everyboan br from fox news. To piggyback on the last question, theres been talk of needing to refrigerator the Pfizer Vaccine at extremely low temperature. Are there plans to either provide more of these refrigeration units to either retail pharmacies or Health Care Providers . Is there a way, thinking back earlier to this year to ramp up production on things like ventilators is there a way to ramp up production, either the defense production act or Something Else torsion bui buil would you mind, either yourself or the doctor to get out the information on the stability of the temperature on the pfizer or moderna. First, general, the cold storage on pfizer. Yes, mr. Secretary. First, the doctor laid it out for us, as usual incredibly well. I will tell you that both pfizer and moderna vaccine, as he said, these vaccines are ready to be administered. And what ive been coaching jurisdictions is dont be afraid of the constraints because of the vaccine and the temperature requirements. We have walked through every individual step on how to maintain a Pfizer Vaccine with ultra cold refrigeration. As well as what does it need if its maintained in the box that its delivered via dry ice. With excruciating detail. So, first, we know where all of the ultra cold storage refrigeration is in the country. We asked the jurisdictions months ago for this data. They went and identified it and tracked it down. They also were provided with resources on how to go buy more refrigeration if they wanted to. To increase the distribution capability throughout their jurisdiction. If it was required. Many states dont requirerefrig. They have enough. And or how do they supplement with dry ice accordingly. So, weve laid all of that out. My message, dont be afraid of the refrigeration requirements, the capability exists. If more is needed, the capability exists to purchase and have it delivered in a timely manner for both refrigeration and dry ice. And then i think so, i think keeping the vaccines refrigerated when they are stored en masse is not an issue as the general just explained. Its important to know, once you thaw them, for the moderna vaccine, you can keep that vial thawed for a month, 30 days, 2 to 8 degrees, thats enough time. With the vaccine, thats enough time clearly to immunize ten individuals. Pfizer, you can seep for five days, thats ample time in the pandemic. Clearly, we feel very comfortable that there will be minimum wastage. And i can tell you, everything is planned to the minute, im learning about how the army wins wars a little bit and its impressive. Thank you, next question. Beth long, you may go ahead and please state your outlet. Thank you, beth long with inside health policy. Im wondering with both of these vaccines potentially getting eua clearance around this time, when will it be determined who gets which vaccine, if theyre both available . And also, how much of the population you expect will need to get vaccinated to be vaccinated to achieve lifespread immunity . Doctor. I think at this stage, the two vaccines have almost identical performance. Of course, it will all depend on the reviews by the fda on, you know, minutia of the data, exactly what label and the safety profile, et cetera. They are very similar in their making and in their performance. And therefore, i dont think there should be any constraints on who gets what vaccine. I think one in the hand is better than two in the bush here. Its a vaccine thats available, it would be my personal recommendation that the cdc and acip will make that call. With regard to your second point, this level of efficacy very impressive, frankly, needs to be complimented. The efficacy against disease. We need to, and we will, be able to assess the capacity of these vaccines to have also have prevented infection. Or if there is infection, whether they impact the amount of virus load that we have that sheds through which we infect other people. Most likely, they are effective against infection. Maybe not at 95 . And most likely, they are effective at decreasing virus load. And therefore virus shedding. Therefore, they should have an impact on transmission. People modeled at anything less than 70 immunized should decrease substantially the virus circulating and therefore, substantially achieve herd immunity. Okay. Just to answer that, we are ready to distribute both vaccines upon eua approval in fair and equitable distribution there that i discussed earlier. We are ready to, simultaneously, if the uea occurs to ship to all jurisdictions. Next question. Carl oconnell. Hi, this is carl odonnell, reuters news. Two questions. Do you for see modernas vaccine being more prevalent and shipping potentially larger quantities in rural areas and hardtoreach areas, given its significantly, you know, less constraining storage requirements . And also do you foresee there being some period of time where only the Pfizer Vaccine is available, just given the time of the eua . Thank you, good question. As dr. Slaoui talked about earlier, were going to wait for the science to lay some things out for us and were going to execute the plans that the jurisdiction has established once they figure out the priority and where they want it to go. I will tell you that we worked the excruciating details to ensure that every area is being thought about, whether its innercity, or extreme rural areas, so that we have the capability and capacity to do so, really, again, the connection is our ability to partner with industry, you know, both distribution and pharma for administration to really achieve that success. And thats, carl, thats partly why, when the cdc and general pernas Distribution Team worked with the 64 jurisdictions, we actually gave them two hypothetical vaccines, with these types of profiles described on them, the moderna and the Pfizer Vaccine profiles. So that as they think about which outlets they would want to use and designate for us to ship to or have shipped to, that they would fit those kinds of profiles. So i think its been built into their jurisdictional planning. And in regard to your question in the lack between the two vaccines being available, as you know, were probably talking about a week or ten days. It will be the call of the fda if they review the files, whether they will hold one back, or two back, but the lag time between the two vaccines is going to be very minimal. Next question. Stephanie alps. You may go ahead. This is stephanie ebs from abc news. You can walk us through a bit more detail what might happen in that 24 hours between an eua and shipment . And specifically, do you anticipate that the acip committee would meet on how to prioritize that initial shipment of doses before it goes 0 tout states or after . Yeah, so, stephanie, thats an excellent question, and im working directly with cdc director Robert Redfield on how we could convene the acip, hopefully, concurrent with the fda review. Customarily, they made until theres a life from fda and 24 hours later theyll meet and provide advice out. But were working to see if we can review a concurrent process thats collaborative with whatever information that the acip would need to do its job. With over 1,000 people perishing per day, we want to our mission in operation warp speed is about saving lives. Every hour, every day matter so were going to work to minimize any type of delay there. Next question. You may go ahead, please state your outlet. This is tom hammel from the washington times. I just want to know if you can give us a sense what type of storage will be used in different settings. In other words, theres ultra low freezers, theres refrigeration and trial ice and thermal shippers. Which kind of places will be it be using it . Have you sorted that out yet . Mostly hospitals, universities and the pharma chains have the ultra cold storage capacity. And it ranges from different volumes of capacity, maintains hundreds of thousands of doses to just limited maybe one or two trays. As i said earlier, we have those pinpointed throughout the country. We know exactly where they are. And how theyre fitting into the jurisdiction plans for distribution. What weve done to really help mitigate the distribution of that vaccine outside of ultra cold storage availability is partnered with pharma, in particular, cvs and walgreens who have mobile capability for both ultra cold, as well as how to distribute out of the pharma excuse me, out of the pfizer distribution boxes which contain dry ice. Theyre well instructed on how to manage the dry ice to ensure that the stability of the vaccine remains the same throughout distribution. The second point to that end is that we are partnering with the states, the jurisdictions and pharma, to ensure that the plan, based on how many doses that we have distributed initially and through the cadence, right, can be whats the word i want to use we want to lead our way through execution so that distribution will be through organizations that allow people to be notified. And be ready for the administration of the shot. At least initially, through, maybe december, january time frame. Until we have more vaccines that will be available throughout as many different locations. Next question. Peter loftis, you may go ahead. State your outlet. Peter loftis from the wall street journal. What steps are you taking to ensure that this whole process continues to go smoothly in the transition to the next administration . Yeah, so, peter, in the event of a transition, the individuals that youre seeing here, other than myself, all of the individuals involved in planning at cdc and on the operations warp speed team, these are career officials. So, they arent impacted by any change in leadership. The work with the states is deeply embedded with cdcs work processes. So, in the event of a transition, theres really just total continuity that would occur. Next question. Emily cox, you may go ahead. Please state your outlet. Hi, this is emily cox with ct calls. Secretary, theres a cnn report that staffers have been instructed if they hear from anyone with president elect joe bidens team that theyre not to communicate with them. I wanted to get your response to that . And then i also wanted to ask, you know, ive heard a lot today about the role of the 64 individual jurisdictions. Are you encouraging the president elect to reach out to those individual jurisdictions to find out the plans in lieu of more meaningful collaboration at the federal level . So, weve made it very clear that when gsa makes a determinations we will ensure complete cooperative, professional transitions. And planning. But thats we follow the guidance. Were about getting vaccines and therapeutics invented and get the Clinical Trial data and saving lives here. Thats where our focus is, as we go forward with our efforts. Operator, we have time for two more questions. Thank you, charles fishman, you may go ahead. Please state your outlet. Charles fishman with the atlantic. Twopart question about dry ice. You can tell us roughly how many of the places receiving the vaccine has the ultra cool freezer and how many rely on dry ice as a percentage . And i think last week, or previously this week, operation warp speed said it would provide to the places that need dry ice the first recharge, the first 750 pounds for each container. You can tell us how youre going to do that . Where is that dry ice going to come from . And hows it going to get to those people who need it the day the vaccine arrives . Okay. So, initially, i dont see anyplace where the vaccine is delivered that it wont go into an ultra cold storage refrigerator. You know, as we are dealing with the initial doses available and were distributing accordingly, weve coordinated and weve asked the jurisdictions to plan for it, to go right into that type of capability, so that we can learn and transition together as we expand doses available to each of the jurisdictions. So, initially, i believe, all will go into ultra cold storage refrigeration. Second point, to your question about the dry ice, we did and we have coordinated and contracted for the first refresh of dry ice to all that we distribute, if it is required. If it goes into the ultra cold storage like i just said, then its not required but theres surely to be exceptions, as we work through every detail across 64 jurisdictions from the pacific all the way through the northeast. And then down to the southeast and then back up to the northwest. There is going to be an exception, and i wanted to make sure we were ready for that. So, weve coordinated industry, commercial industry for dry ice production. Weve coordinated through them, as well as in particular, pfizer to help with this. And then distribution will be through fedex and u. P. S. So, i feel very confident in that plan. Great. I think weve got time for one last question, please. Thank you. Hassan alma, you may go ahead. From aft. My question was, since, you know, this approval seems like its a matter of just a couple weeks away now, what does that mean for those phase three trials and how you go ahead collecting data . Since its approved, people on the placebo obviously want to get the actual vaccine. So how does that affect how we accrue more scientific information . And is it still phase three then . Or moving on to phase four . If you could talk about that, please. So, very important question. Thank you for asking it. And one that we have been discussing at length with all of the parties involved. First thing to say is, unfortunately, the rate of transmission in the country is such that as pfizer, for instance, has already reached the final analogies, you know, the number required for the final analogies and announced it today, it is very likely that moderna will also be shortly attaining that number and announcing it. From the standpoint of efficacy analysis, the trials will have achieved their objective. From the standpoint of longterm follow up into the trials, the trials could still generate substantially important information, such as persistence of perfection over time. And safety over time. In that regard, we are working with the fda and with the companies on when to crossover the Placebo Group to the vaccine. And within the Placebo Group, where that crossover should happen in a staged way, depending on the prioritization, for instance that the cdc and acip would have put forward. That will happen. The question is more when. Is it at eua approval . Is it when 10 of the population has been immunized for a particular start of the population that has been prioritized . Is it when the bla is approved from a regulatory standpoint is the trigger point, thats the latest possible. So were talking about a period of maybe two or three months which is currently which is what we project between the time between the eua and the bla. We always said that the eua was a pit stop on the trajectory to a bla and thats the case. So it will happen. It will have, therefore, an impact on our capacity to have controlled data. But it will not impact our capacity to continue to have data. We just will not have the control group anymore as they would be immunized. There are strategies to extract information from that. At that stage, well also potentially have impact on recruiting subjects in other Clinical Trials. Now, i do want to make a point here and a plea, frankly, which is we now know that vaccination is possible. Not only its possible, but its incredibly effective. Its very likely that the other vaccines that are being tested will also be as effective or substantially as effective. I would really ask for the population of people who want to volunteer and help to come and participate into the Clinical Trials, a. , because without their participation, its impossible to know whether more vaccines can be demonstrated to be effective and safe. And made available to the population. But also theres here, i think, a clear potential benefit which is the eua may be approved in the middle of december or so. And by the time the vaccine starts to be laid out, you may, as an individual, only have access to the vaccine in a month and a half or two months, if you farp in a cl participate in a Clinical Trial, you have a 50 chance of having access to the vaccine tomorrow. Both from an altruistic standpoint and a personal standpoint it would be great for populations across the usa to please go and participate in Clinical Trials, any one of the Clinical Trials. Thank you. Thank you. And thanks to the media for the excellent questions. Just two concluding points. First, as i mentioned, well try to have these technical briefings occur on a regular basis for your benefit. Second, for your readers, your listeners your viewers, id just ask you to please keep emphasizing with the vaccine news that we have. With the therapeutic approval we have there is light at the end of the tunnel. But we need people to get there. And the way people get there is practicing good individual behaviors of washing your hands, watching your distance, wearing your face coverings when you cant watch your distance. And avoid settings, especially now as getting colder. Indoor settings like crowded indoor restaurants or home base settings indoors where youre getting together with family, friends and neighbors and not watching your distance and wearing your face coverings, letting your guard down, you put yourself at risk. Please do those thing because thanks to the great work of these individuals, thanks to president trumps leadership of operation warp speed. Thank to the worlds great bio pharmaceutical industry theres such promise ahead. We want you all to get there so you can take advantage of it. Thank you very much for being with us today. This afternoon, a senate panel will examine federal agencies response and transition to telework during the pandemic. You can see live coverage of this Homeland Security and Governmental Affairs subcommittee hearing starting at 3 00 p. M. On cspan3. Online with cspan. Org or listen with the radio app. Week nights this month, were featuring American History tv programs of whats available every weekend on c span 3. Tonight, the National Museum hosts neal bascomb. He describes how a tip from a holocaust survivor and his daughter in argentina led to the capture of nazi war criminal adolph
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