HHS Briefing on Operation Warp Speed, Vaccine Distribution Transcript December 2

Operator: (00:09) Welcome and thank you for standing by. At this time, all participants are in a listen only mode. At the end of today's presentation, we will conduct a question and answer session. To ask a question, please press star one. Today's conference is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the meeting over to Michael Pratt. You may begin. Speaker 1: (00:28) Thank you operator and thank you all for joining today's briefing to discuss updates on Operation Warp Speed COVID-19 vaccine development and distribution. Briefing today will be Secretary Alex Azar, Dr. Moncef Slaoui, chief scientific advisor to Operation Warp Speed and General Gus Perna, chief operating officer for Operation Warp Speed. All three briefers will make opening statements and then after which we will open the floor for on topic questions. Their statements and answers to questions today will be on the record and we kindly ask that you keep your questions related to the topic of today's briefing. When asking a question, please state your name and publication and keep your questions as short as possible so we can get to as many questions as we can in the time we have. Any the off topic questions or follow up can be sent to media@hhs.gov. We will now bring the briefers out on the stage and begin after they're set. Alex Azar: (01:40) Hello everyone and thank you 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 Moderna's announcement on Monday, two companies have now filed EUA applications with the FDA, out of the three companies that have shown promising data for efficacy in phase three trials. On top of that, more OWS supported candidates are well on their way in that final phase of clinical trials. FDA has now scheduled a meeting of its vaccine advisory committee to review the Moderna 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. Alex Azar: (02:50) If all goes well, as General Perna will lay out, that means we can make our first shipments of vaccine to states this month and we are on track to be able to ship enough vaccine for 20 million Americans before the end of the year. Of course, we're all eager to have enough supply to 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. Alex Azar: (03:28) As all of you likely know, yesterday CDC 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. Alex Azar: (04:05) As we approach the vaccine rollout, we're also continuing to expand access to treatments for COVID-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 3,000 sites are currently signed up to 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 in even more convenient locations. As we've mentioned, Americans need to know that this treatment is a possible option for patients who are at high risk for severe COVID-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 COVID-19. Receiving this treatment, if you're in that category, could help keep you out of the hospital, potentially helping to save your life. Alex Azar: (05:12) We want to encourage the news media and all Americans to spread the word about the availability of COVID-19 treatments and want to encourage Americans to start playing the role that they'll have in 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 CDC's website to find out more about the vaccines we're developing and the process they've gone through. Alex Azar: (05:52) If you have questions now or have questions further down the road, talk to your healthcare provider about the importance that safe and effective vaccines have to our own health and the health of our communities. These vaccine products will be assessed with the same rigor that Americans can expect when it comes to any other vaccine or drug that is reviewed by the FDA. As each one of us here has said, we're excited to take this vaccine and we will encourage our family and friends to do so too, as appropriate. Alex Azar: (06:23) 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 to just make a plea to individuals who have had COVID-19 and recovered, if you're within three months since recovery from COVID-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 COVID-19. We unfortunately have so many individuals who have gotten COVID-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 for more information about how you can volunteer to be a donor and give the gift of life. With that, I will turn things over to the extremely capable hands of our leaders, Dr. Moncef Slaoui and General Gus Perna, who will lead the rest of this briefing and the Q and A and I will see you at this briefing next week. Thank you very much. Dr. Slaoui. Moncef Slaoui: (07:33) Thank you, Mr. Secretary, just a few points to add to I think the excellent summary that the secretary has provided. Very, very rich week in new data and information. On the Moderna vaccine side of things, the final analysis has now been completed with 94.1 efficacy against moderate and severe disease. Importantly, there were 30 cases of severe disease in the trial, all 30 in the placebo group, so a 100% efficacy. There were 7,500 and some elderly people with age over 65 and efficacy in that population against moderate disease was 87.1% and efficacy against severe disease was also at a 100% since there were no cases in the vaccine group. I think those are very important data to keep in mind. It is exceptionally good data and in fact, remarkably similar to the data that you have already seen coming with the Pfizer vaccine. Moncef Slaoui: (08:53) And obviously as the secretary said, the fact that an external regulatory agency of the highest caliber and standards equivalent to those of the FDA, the UK MHRA has approved the Pfizer vaccine. Of course they have not been part, involved in any of the politicization that surrounded the development of this vaccine and I hope this will be another evidence for the American population that the data with these vaccines are clear, are transparent and demonstrate that they are effective and safe for use in the general population because as the secretary said, vaccines are useless if they are not used to vaccinate people. Moncef Slaoui: (09:48) I think also really great progress with two other vaccines in the pipeline. Johnson and Johnson vaccine which is a recombinant human adenovirus 26 vector has now recruited a little bit more than 28,000 subjects in the phase three trial. Now the breakthrough that we hope with this vaccine is that it's a one shot vaccine with very fast efficacy achieved and a 100% compliance, so to speak since everybody will 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 Pfizer vaccine to have their first vaccine dose and then come back either three or four weeks later to get their second vaccine dose to complete the immunization schedule. Moncef Slaoui: (10:40) The next vaccine in the line is the AstraZeneca chimpanzee adenovirus live vector vaccine. The phase three trial is conducted here in the US under the Operation Warp Speed oversight. So it's different trial than the UK Brazil trials that have been communicated about last week, is progressing very well. We have about 15,000 subjects recruited in the trial. Both Johnson and Johnson and the AstraZeneca trial are likely to complete their efficacy requirement, which is the number of cases accruing in the study, somewhere between very late in December and the middle of January. Given unfortunately that the pandemic is extremely active and there is a lot of transmission in the population. Moncef Slaoui: (11:34) 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 enough vaccine to immunize 20 million people in the US in December, that's 40 million doses, and 30 million people, 60 million doses in January and 50 million people or a 100 million doses in February. And end of February, we will have potentially immunized a 100 million people, which is really more or less the size of the significant at risk population, the elderly, the healthcare workers, the first line workers, people with comorbidity. I'll close there. Of course, be happy to answer your questions later on and pass on to General Perna. Gus Parna: (12:38) Thanks, Dr. Slaoui. As always incredibly well informative for us. All right. Team, today I just want to talk quickly about three things. Allocation update, our distribution in support of the state plans, our ability to empower them to execute their plans and then third, just to reinforce the challenge, my word, to Secretary Azar's comments at the end about learning about vaccines. Gus Parna: (13:10) First, reference allocations. We have provided the 64 jurisdictions, which a reminder is the 50 states, eight territories and six mega cities, as well as five federal agencies with their allocations of the vaccines that are going to be available in the month of December. What we've done is we believe, for planning purposes only, we had to pick a day and I've coined the phrase snap the chalk line, so that we could plan on actual doses that will be available. Gus Parna: (13:47) For example, a 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 or a total of 6.4 million doses that will be available. A week later on 27 November, we provided the 64 allocation jurisdictions and five federal agencies their allocations for the Moderna vaccine at 12.5 million doses, that'll be available. Again, we are planning to be ready when EUA is approved. It is not about getting in front of EUA, it's just making sure that we have everything locked so when EUA decision comes, distribution to the American people becomes immediate within 24 hours. That's our goal. That's what we're striving for and that's what we're working to. You can't execute if you don't have a plan and that's what our emphasis is as we work through all that process. Gus Parna: (14:57) We are going to send half the doses based on allocations to the jurisdictions and agencies, because it is a two dose regimen, as Dr. Slaoui just talked about, so half of the allocation will be sent out and then 21 days later for Pfizer and 28 days later for Moderna, we send out the second half of allocations. Two reasons, one, to ensure that we don't over administer and that we have the second dose on hand. And 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 utilize a Tiberius platform that we developed, which is a capability that takes in all the informative data from the states, hospitals, doctor's offices, pharmacies. Gus Parna: (16:03) ... doctor's offices, pharmacies only on the specification of vaccine as it is delivered and vaccine as it is administered so that we can maintain the flow of vaccine to the American people. As I've talked about, our goal is to distribute within 24 hours after EUA and the first pushes. Then we want to maintain a cadence, a deliberate, planned, coordinated cadence of delivery of vaccine as it becomes available. The only way you can do that is if you see yourselves. And we have to see ourselves from point of administration all the way back to point of finish. And in doing so, then we can coordinate, collaborate, plan together the distribution of vaccines down to the states. Gus Parna: (16:56) We have requested that the states lock-in micro plans for final distribution of both vaccines. So for example, this week we've asked the states in total jurisdictions to have their micro plans in Tiberius by the end of the week or for December. This way, we can ensure that we understand all the places where they want the vaccine delivered and at what quantities they want the vaccine delivered. And then we can coordinate with Pfizer to ensure those boxes are prepared and ready to be distributed upon EUA. Address is 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. Gus Parna: (17:50) We've asked for the states and jurisdictions to have their micro plans ready for the Moderna vaccine by the 11th of December, which allows them to do the same planning. And in theory, what happens is the vaccine comes in to where they want. It enables their plan for immediate administration of the vaccine to the priorities that their governor establishes at each state. Here's the key. The states know their people, their populations the best. And as they follow through with eventual EUA guidance and the ACIP guidance that was put out yesterday, then you have leaders taking responsibility and directing a priority of vaccine into administration or shots in arms. Our responsibility is to enable their plan, to empower their plan. And that's why we've asked for the micro planning and the detailed work to happen accordingly. Gus Parna: (18:55) After the initial pushes go out for Pfizer and Moderna, then every week, based on availability of vaccine as Dr. Slaoui alluded to, 40 million total doses in December, and then January, February, and March, we are going to push allocations as the vaccine becomes available. We are not waiting for cluster of vaccine to be available and then push. We want to have this [inaudible 00:19:25] cadenced delivery of vaccine so the states can best manage it to the priorities as they've developed it. Gus Parna: (19:34) We envisualize each week additional vaccines getting out and eventually we just continue to build on the amount of people that get vaccinated and hence on our way to ending this pandemic. Jurisdictions and the governors quite frankly will decide where they want it to go at the end of the day. And we're enabling to that end. Gus Parna: (20:03) So I just would reinforce in this point here, allocations made, jurisdictions planning. We're trying to enable them to work through their priorities, to best take care of the people of their jurisdictions accordingly. Gus Parna: (20:20) Second, I'd like to talk to you about how we are working to empower the states and make sure that they are well-informed of all the processes that we have available. I just want to commend the CDC for the remarkable work that they are doing. These great leaders, these very, very talented professionals, well-trained experts in this field of distribution have really set up an elaborate coordination and collaboration effort with the states. They run daily, weekly meetings. They work through detailed execution of plans. They make recommendations on how to best facilitize and operationalize the distribution, and then they figure out ways to enable the state and jurisdiction plans. Really well done by the CDC and I'm really proud to be a part of the collaboration with them. Gus Parna: (21:25) Second, we've worked a very elaborate update in talking to the governors, either through HHS or up through Vice President Pence's sessions with them, but also through individual phone calls to the governors, to their health coordinators at the senior leadership level, to make sure we're answering questions in a timely manner and getting them solutions to their problems. Again, we want to enable and empower the jurisdictions to execute their plans. That is our sole goal, our responsibility to do. And we've worked extremely hard. Gus Parna: (22:08) Two things I've coached people on. Over communication is an asset to our execution. And then second, you got to do the virtual circulation. We have to see what the governors and our staffs are seeing so we can best enable them. Clearly, one of their concerns that they're working through is how to do nursing homes, long-term health care facilities. And the CDC and OWS collaborated, really worked a very extensive plan in collaboration with CVS, Walgreen, and other private pharmacies to enable state governor plans on getting to those facilities. How do we get it out to them? How do we make sure that we're there to administer to them? And I am incredibly confident that these private public-partnerships are ready to execute based on the governor's priorities and plans to do so. And I am excited to watch that to get operationalized. Gus Parna: (23:22) The last thing I'll leave you with in touching with Secretary Azar's comments and reinforcing Dr. Slaoui's comments on really the great potential and efficacy of the vaccine is as we go forward, a vaccine is only good as it being administered to the American people. And so I just ask everybody to really educate yourself right, figure out what you want to do as an individual, but be informed in your process. Don't allow one headline to determine what you're going to do. There is so much available information, and I just encourage everybody as an individual, a community, and of course, as a part of our great nation to really inform yourself and then make the decision that is best for you and your family. And so with that, Dr. Slaoui, I think we take questions. Speaker 1: (24:23) Thank you. Operator, we can open it up for questions now. And a friendly reminder to our immediate friends that when asking a question, please state your name and publication, and please keep your questions as short as possible so we can get to as many questions as we can in the time that we have. I'll turn it over to you now operator. Operator: (24:40) Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star one. Please unmute your phone and report your first and last name as well as your organization clearly when prompted. To withdraw your question, you may press star two. Once again at this time, if you would like to ask a question, please press star one. And our first question is from Meg Tirrell. If you wouldn't mind stating your organization, your line is open. Meg Tirrell: (25:08) Thank you. It's Meg Tirrell with CNBC. Dr. Slaoui, I was wondering if you could just sort of go back through those allocation numbers per month that you laid out. I wanted to make sure we got it right. The 40 million doses December, 60 million January, 100 million in February. Is that just Pfizer and Moderna's vaccines? And then to follow up on something General Perna was saying, with only half the doses 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? In the first 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 right terminology for us to be using? Moncef Slaoui: (25:57) Thank you Meg for the question. So the numbers were indeed, and I used the number of people to be vaccinated with the complete dose of vaccine, so two shots. 20 million in December, 30 million in January, 50 million in February. And that's with the Pfizer and Moderna vaccine. Moncef Slaoui: (26:18) There is a chance that we may have more vaccine doses available in February, particularly with the Janssen's vaccine if the Janssen vaccine gets emergency use authorization approved. So, as I said, it's possible depending on the number of cases accruing that that phase three trial completes its efficacy endpoint during the month of January. So there may be a scenario where we could have a little bit more with a one-shot vaccine. With that vaccine one dose equal one person immunized. My recommendation is to use a number of people immunized. I think it's more factual. I mean, more real to people. Operator: (27:02) Our next question is from John Collins with Science Magazine. Your line is open. John Collins: (27:08) Hi. This is [inaudible 00:27:11]. Dr. Slaoui and Secretary Azar praised the decision by the HRA to approve Pfizer. But the EMA in Europe and many European leaders have really criticized it as being hasty. And our own FDA process obviously is transparent and slower, meant to build confidence. I wonder whether you want to clarify things that others are heavily criticizing in Europe. Moncef Slaoui: (27:42) Well John, we don't know exactly how the process has taken place. As you know, we stay totally away from the regulatory process, whether with the FDA or with others. What we understand is that there have been rolling submissions where different parts of the file to be authorized have been submitted at different time point. I would speculate that Pfizer manufacturing, CMC part of the file must have been filed quite a while ago. And therefore, potentially the review has focused on the clinical side, the rest of it having been done earlier. But frankly, I cannot comment. Moncef Slaoui: (28:31) What I would agree with you completely is we know the FDA process is 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 that the HRA is an extremely high grade agency. In fact, within the EMA, before they left it, they were certainly the scientific engine, the UK, and the PI, German part of the agency. Thank you. Operator: (29:13) Our next question is from Zachary Brennan. Please state your organization if you may. Your line is open. Zachary Brennan: (29:21) Thanks for taking my questions, Zach from Politico [inaudible 00:29:24]. General Perna mentioned earlier that about 21 jurisdictions still haven't signed on to these data user agreements. What's going to happen with those jurisdictions if they ultimately don't sign onto those? And then, can you talk a little bit about why certain states are saying the vaccine allocations are a lot smaller than what they originally had thought? Gus Parna: (29:46) So, yes. 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 confident that all the jurisdictions will have their data use agreements in and everything will be all right. To your second question, what we're doing is, instead of waiting until the end of December where we know we'll have a cumulative amount of vaccine, as Dr. Slaoui mentioned, and I reinforced at 40 million doses, what we're doing is at the time of we speculate EUA is going to occur, the doses that'll be available is 6.4 million for Pfizer and 12.5 for Moderna. And that's what we did the initial allocation based on. And so that push will go out based on those allocations. Gus Parna: (30:40) But every day that goes by after the initial push, additional vaccines come off the shelf because they've been certified and approved for distribution and administration. Hence, what I talked about, the continuous cadence of delivery of vaccine going out to the American people. So it's not a one and done. It's a initial push and then a continuous cadenced flow of vaccine for planning and coordination and execution. Thank you. Operator: (31:21) Our next question is from Stephanie Ebbs with ABC News. Your line is open. Stephanie Ebbs: (31:27) Thank you, Stephanie Ebbs from ABC. I wanted to follow up on that General Perna. When you're talking about the continued cadence of deliveries, how will the amount in those deliveries be allocated? And is it correct to say that then each subsequent delivery would be followed by a delivery of the same amounts 21 or 23 days later? Gus Parna: (31:48) So what we're doing is through Tiberius, the program that we establish, which is located at each of the jurisdictions, we're establishing the available doses of vaccine to each state. And so they get to see ... General Perna: (32:03) ... the vaccine to each state, and so 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 to have the vaccine to go to, manipulate it so that they can see impact of the doses going to those locations, and then once it finally approved, they hit send, and 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. Can anybody help me on that one? I can't remember. Moncef Slaoui: (32:46) It was the allocation. In the states, how will you allocate those to each state population? General Perna: (32:51) Yeah. So, pro rata. Moncef Slaoui: (32:54) Yeah. Speaker 2: (32:56) Will you hold the second dose? General Perna: (32:56) Oh, I apologize. I apologize. Thank you. So the second part of the question was are we going to hold the second dose for every distribution as we go forward in the cadence? And the answer is yes. 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 for everybody as they get administered their shots. Over. Thank you. Over. Moncef Slaoui: (33:29) Next question? Operator: (33:32) Our next question is from Steve Hausen with BioCentury. Your line is open. Steve Hausen: (33:37) Hi. I wanted to ask if there are 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? Moncef Slaoui: (33:54) Yes. So the FDA and the CDC are working very closely together to put together a very active pharmacovigilance and surveillance system using various, very large databases currently in use and integrating all the data from those databases with potentially frequencies of assessment of events, as frequently as every other day, which, frankly, gets even closer than what happens in a clinical trial. And the covered population will be very, very large, include large elderly populations, large VA-related population, and global population through various insurance carriers, so I think a very extensive plan. Next question. Operator: (34:54) Next question. Our next question is from Kevin Brown with Fox News. Your line is open. Eben Brown: (35:03) Hi. Good afternoon. Eben Brown with Fox News. If both gentleman could once again talk about whatever push is being done from a messaging standpoint to encourage as many people to get vaccinated, to quell their fears and really inspire them to take this action. 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, when they would be able to get a vaccine, either at their doctor's office or a corner drug store? Moncef Slaoui: (35:40) So I think it is every expert's, frankly, duty today, as we get more and more exposed to the data, which will become totally public at the time of FDA review with the VRBPAC 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 to the people that they interact with, because I think what I say is for everybody to keep ... Let's keep our ears open and our mind receptive to the information, the factual information on the performance of the vaccine, both its safety and its efficacy, and then make our judgment whether we will use it or not. And the experts across the country should take accountability of participating into that process to translate that scientific data for everybody to be able to understand it. Moncef Slaoui: (36:56) 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 as long 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 specifically, and maybe General Perna can comment further on that, in each state there should be active communication as vaccines now become available for people to go to the vaccine in a Walgreens or CVS or elsewhere or their physician and be administered the vaccine. General Perna: (37:37) Yeah. So just to just take off where Dr. Slaoui left is even this session here with you asking questions and getting the facts directly from us provides, I think, the American people with confidence, number one. Number two, Health and Human Services is working a rollout of a communication strategy that will talk about overall confidence of vaccines. Nevermind COVID, but total vaccine confidence. They will narrow it down to the COVID vaccine itself, and then they're going to start to establish communication at the national, state and local community level on when vaccines are going to be available to all persons in appropriate time accordingly. As said, initially to probably healthcare workers, frontline healthcare workers, and then 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. Moncef Slaoui: (38:56) Next question. Operator: (39:00) Our next question is from Candice Choi with the Associated Press. Your line is open. Candice Choi: (39:07) Hi. Thanks. How closely will you be urging states to follow ACIP's priority recommendations, and do you have any indications that the distributions might vary from those recommendations? And is there going to be any federal guidance on whether people who've been infected should get the vaccine? Moncef Slaoui: (39:27) So in regard of your second question, here are the facts. In the trials, people were recruited on the basis of not having had overt clinical COVID disease, so symptoms, et cetera. On that basis, they were recruited. It turns out anywhere between 5% and 10% of the subjects recruited were seropositive to COVID-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 of seropositives have been immunized, and their immune responses are being analyzed. My expectation is that they will have very, very high immune responses in response to the vaccine because they were already primed through the infection. Moncef Slaoui: (40:24) Where we do not have data is in subjects, individuals who have had overt disease. That's an important question that we will need to address through clinical studies. Now, what we also know from the literature is that people who get overt disease in general have a higher immune response to the virus than people who have subclinical disease, so the expectation is for them to be more protected, but the studies will need to be done. General Perna: (40:57) What we do know to the first part of your question is that the staffs at each of the jurisdictions are highly professional, medically trained and have a clear understanding of the role of the FDA and the EUA and the CDC/ACIP. And we are 100% confident, 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. Moncef Slaoui: (41:35) Next question. Operator: (41:38) Our next question is from Angelica LaVito with Bloomberg News. Your line is open. Angelica LaVito: (41:45) Thank you. Will all of the initial doses be available 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 in what priority order? General Perna: (41:58) So right now, the allocations are for the 64 jurisdictions and five federal agencies, but they're all going to go out simultaneous, fair and equitable to the amount that's available. It's pro rata to population. I insisted on it. It's a math problem in execution so that we can ensure fair and equitable distribution. Moncef Slaoui: (42:27) Next question. Operator: (42:30) Our next question is from Tom Howell with Washington Press. Or, I'm sorry, Washington Post. Your line is open. Tom Howell: (42:38) Hey. It's Tom Howell 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. Do they have enough funding to ... It's one thing to ship it to them. Do they have enough funding to distribute it, or do you need Congress to step in and provide more? General Perna: (42:58) So a lot of work is going in in the collaboration and coordination of the distribution to what we would like to see down to the lowest level, and so as long as they have the provider enrolled, i.e. a doctor's office, a hospital, CVS, Walgreens, et cetera, then the vaccine can be delivered to those locations and, in theory, administered at those locations. If the state chooses that they would rather have it go to certain ... And we will deliver it to those locations. If a state chooses they'd like to execute a hub and spoke to ensure that they are executing their plan, we will deliver to the hubs that they designate. And if they require additional assets and support from there, we've been talking to them about making sure they have a detailed plan with specificity and what the requirement would be, and then to let us know so that we can help enable them with that. They have received funding in this light previously with additional funding. Up to $200 million with an additional $140 million being distributed out to the jurisdictions this month to support them in that execution. Moncef Slaoui: (44:26) Next question. Operator: (44:28) Our next question is from Rebecca Robbins. If you wouldn't mind stating your organization, your line is open. Rebecca Robbins: (44:35) Hello. Yes. This is Rebecca Robbins from the New York Times. Thank you for taking my question. My question pertains to 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 an emergency use authorization. Do you anticipate that they will need to submit data from the phase three trial in the United States? And was that the plan, and if so, how long has that been the plan? Thank you. Moncef Slaoui: (45:12) So first, I should say that the FDA defines what the FDA would like to see into the file, and 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 efficacy and safety. That data is still being digested because of the contrasted outcome that happened in regard of the immunization regimen that was used, and it's not obvious or straightforward to come to a conclusion why there appears to have been substantially different efficacy outcomes, 90% to 62%. And frankly, unless there is a very clear explanation based on facts and data of what's behind those two numbers, it's very likely that that package will not be sufficient for an approval. I'll be the first one to say, so I'll say it here. But, of course, the FDA will make their own decision. Moncef Slaoui: (46:21) 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 been produced, and those facilities are 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 US. On top of that, the FDA will want to understand and characterize the manufacturing process it's been using here in the US at Emergent Bio Solutions 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 in the clinical trial. Moncef Slaoui: (47:20) My hunch is that by the time we generate AstraZeneca, Oxford University, all these set of data, the data from the ongoing efficacy trial phase three in the US 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 a trial that we and the FDA have overseen totally, and ultimately it may have the largest weight in a decision around that. I don't think it changes a lot the timelines. I still would expect that somewhere in ... Moncef Slaoui: (48:03) ... the timelines. I still would expect that somewhere in January, maybe more towards the second half of January, data will become available, and potentially an emergency use authorization could be filed. Thank you. Next question? Operator: (48:19) Our next question is from Sara Murray with CNN. Your line is open. Sara Murray: (48:25) Hi, thank you all for doing the call. I appreciate it. First, I just wanted to see if you could tell us the five federal agencies that will be getting the vaccine allotment? And secondly, just to clarify the data systems, will each state be responsible for tracking the first shots in their residents, and then making sure they come in for the second shots. Is there any sort of federal role in that system? Or is it all up to faith? General Perna: (48:57) So the five federal agencies are the Veterans Affairs, Department Of Defense, Department Of State, Indian Health Services, and Bureau Of Federal Prisons. The second question about tracking second doses, what we have done is we've set up everything from draconian process, where when we sent out the ancillary kits, which have needles and syringes, we've included paper cards to be filled out and sent, given to the individuals reminding them of their next vaccine due date, accordingly. Encouragement of taking a photo of it, putting it in the wallet, et cetera. You know, we're working at the draconian level there. General Perna: (49:46) Second, states are working plans for notification. Notification and information inside of state laws is very particular in some states, very open in others. And each state is working that plan inside of their own, within all the rules, and regulations, and laws. We do know that pharmacies, such as CVS and Walgreens, have established very elaborate tracking systems to set up appointments, notify people when their second shots are required, et cetera. General Perna: (50:27) At the federal level, what we're working, and we have capability and capacity, to send second dose messages out only if, and when, it's in collaboration with the state's laws, and regulations, and policies. So triple canopy approach to try and make this work. And we're doing our best to capture everybody to ensure that they get their second dose. Moncef Slaoui: (50:57) Thank you. Next question? Operator: (51:01) Our next question is from Emily Kopp. If you would mind announcing your organization. Your line is open. Emily Kopp: (51:07) 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 to make a decision by that date, given that's the date you're planning on? Thanks. General Perna: (51:31) Okay. So I'm an army general. An army general's plan. And so literally, I got up on my whiteboard, and I said, "Oh, they filed for EUA on this day." And then I got word that said, the VRBPAC sessions were going to be on this day. So they filed, VRBPAC was specified, and then I said, "Okay, somewhere in this window, after they work through the details, is probably the earliest potential opportunity for an EUA." General Perna: (52:08) My whiteboard clearly speculates only if the EUA approve would distribution begin. But we needed to do 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 want to distribute available vaccines immediately following, several administrative things have to occur. General Perna: (52:36) One, the states need to tell us where they would like the vaccine delivered to at what quantities. Two, the companies have to prepare the packages. 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, the notification to the administration sites that they will receive a vaccine accordingly. General Perna: (53:19) So in simple terms, it is a whiteboard plan. It is meant to help us prepare, but it is not constraining to execution. And there is 100%, without question, no interference with the FDA in they're very deliberate, arduous effort to make sure that we have the right solution if, and when, they do approve EUA. Moncef Slaoui: (53:49) Thank you. Next question? Operator: (53:54) Our next question is from Caitlin Kenney with as Stars And Stripes. Your line is open. Caitlin Kenney: (54:00) Hi, thank you. Caitlin Kenney with Stars And Stripes. Since the DOD has gained their own allocation, can you talk a little bit about what their distribution plan is among the force? Do they have their own priority of who gets the vaccine first, or are they following the phase 1A for their health care workers, and then phase 1B for who they believe are essential workers. Thanks. General Perna: (54:22) So just like we're doing for the jurisdictions, the federal agencies have their own plans. We're supporting them with fair and equitable allocation, based on population of their force. And so they will figure out their plan. They're well understanding and they have the same professionals that the jurisdictions have in their alignment and execution of the FDA and EUA guidance, as well as the CDC and ACEP guidance. I do not know what the Department Of Defense's plan is after that. Speaker 3: (55:02) I think we have time for two more questions on today's briefing, and again, follow up questions can be sent to media@hhs.gov. We'll take two more questions. Operator: (55:11) Our next question is from Amir [Erfan 00:55:14] with Vox. Your line is open. Amir Erfan: (55:18) Hi, this is Amir Erfan. I'm a reporter at Vox4. Dr. Slaoui, you talked a little bit about the Johnson & Johnson Janssen vaccine, that's a one dose vaccine. How would that coming into fruition affect the plans for distribution? Would Operation Warp Speed shift its resources toward a one resource vaccine, or how will that allocation proceed at that point? Moncef Slaoui: (55:39) Well, I mean, first, of course, we need to look into the performance. I should say that strategically, we decided with that vaccine to try a one-shot vaccine, but at the same time we also decided to test it as a two-shots vaccine, and that phase three trial has started already, so we cover all bases, if you wish. Moncef Slaoui: (56:03) In terms of distribution, General Perna can comment further, but there should be no difference. It's literally entering to the cadence of distributing the dose, except there will be no recall to the subject that's received the first dose to come back. It's going to be effectively more efficient, faster strategy to immunize, which is particularly important when there is a very active pandemic. And that's the reason we wanted to assess that potential. Thank you. General Perna: (56:35) Yeah, I'm sorry. Moncef Slaoui: (56:35) No, go ahead. General Perna: (56:36) It would be additive to the amounts that we're sending out from Moderna and Pfizer. And then we would do our initial push based on EUA and what's available. And then we would put them in the cadence, as Dr. Slaoui indicated, in normal routine distribution accordingly. So the states and jurisdictions would then have three vaccines to distribute to their plan. Moncef Slaoui: (57:05) Final question, please. Operator: (57:08) Our last question is from Andrew Dunn with Business Insider. Your line is open. Andrew Dunn: (57:24) Andrew- Operator: (57:26) Yep. Go ahead, sir. Moncef Slaoui: (57:37) We can't hear anything. Somebody's on mute. Speaker 3: (57:46) Operator, we'll go to the next question. Operator: (57:49) Sure, not a problem. Our next question is from [Hassan Ahmed 00:57:52] with ASP. Your line is open. Eben Brown: (57:56) Hi, thank you for taking my question, and for doing this interaction. Can you hear me? Moncef Slaoui: (58:02) Yes. Eben Brown: (58:04) Yeah, so I had a question for Dr. Slaoui, if you've been following at all the Russian data with regards to the Sputnik vaccine, which I know they haven't accrued that much, but it looks relatively promising. I wonder if you had any thoughts regarding that? And whether that could ever be a possibility for the US? And the second part of the question was, do you expect all three million nursing home residents and most healthcare workers to be vaccinated by the end of this year? Moncef Slaoui: (58:37) So regarding the first question, frankly, very scarce 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 human adenovirus five, has been associated 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 been done on their vector to avoid what should obviously be avoided, which is increased susceptibility to acquiring HIV. I believe it was in the male population. Moncef Slaoui: (59:28) As regard to the vaccination of the long-term care facility, residents, elderly, frail people. It's really going to 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 each state health agency, so it's not for us. What I can say is there will be ample amount of vaccine available to immunize the three million such residents by the end of the month of December. Speaker 3: (01:00:09) Thank you, Dr. Slaoui. Thank you, General Perna. 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@hhs.gov. And with that we'll close today's briefing.