Army Gen. Gustave F. Perna, chief operating officer of Operation Warp Speed; Dr. Moncef Slaoui, chief advisor to Operation Warp Speed; and Health and Human Services Secretary Alex M. Azar II brief the media on Operation Warp Speed and COVID-19 vaccine distribution, December 9, 2020.
Hello, everyone, and thank you for joining this briefing today. Thanks to President Trump’s unwavering support for Operation Warp Speed, we have more good news to report this week. Yesterday, the FDA released an internal assessment of the Pfizer vaccines trial data. The FDA assessment showed that the vaccine was around 95% effective, was efficacious across different groups, including the elderly and people with co morbidity ease and did not show any significant safety concerns. This analysis is being presented tomorrow to the FDA is Vaccines and Related Biological Products Advisory Committee, which will weigh in for the agency’s consideration on whether they believe the vaccine meets the criteria for emergency use authorization. We could then have an easy way within days and be administering doses of vaccine to our most vulnerable next week, as we’ve discussed, based on current production schedules, we expect to have enough doses to vaccinate 20 million Americans by the end of this year, 50 million total by the end of January and at least 100 million total by the end of the first quarter. We remain confident that across our portfolio of multiple vaccines, we will have enough doses for any American who wants a vaccine. By the end of the second quarter of 2021 as we’ve continued to make progress on vaccine development and manufacturing, General Pern and his team have been in close touch with our state partners on how we will be allocating and distributing the doses as they become available. We’ll also be releasing MAWR informational material in the coming days and weeks for Americans to help spread the word about the safety and efficacy of the coming vaccines. We also continue to allocate and ship MAWR courses of the two authorized antibody treatments to help Americans at risk for Severe Cove in 19 who have not been hospitalized. As of today, we have now allocated more than 278,000 courses of these treatments. As I’ve noted in previous weeks, every American who’s recovered from Cove in 19 in the past three months can help expand our arsenal of potential treatments for this virus by donating plasma. Millions of Americans have recovered from Cove in 19 in the last several months and could be eligible to donate. Please contact your local American Red Cross or local American blood bank or go to Corona virus dot gov for more information about how you can volunteer to be a donor and give the gift of life, I’ll conclude by reminding all Americans that even as we have such a bright future ahead, we face extremely concerning trends in the spread of the virus. Hospitalization rates are now at the highest they have been during the pandemic. We’re so close to being able to protect millions of Americans from this virus with the vaccine. For now, we need to double down on the steps that can keep us all safe. The three W’s Wash your hands, Watch your distance where face covering. You can’t watch your distance and avoid places like indoor settings and crowded out crowded settings where you can’t do those things. Those public health measures are the safe bridge to a vaccine. Thank you again for joining us, and I’ll now hand things over to Dr Slowey to give us updates on the vaccine development front. Thank you, Mr Secretary. Hi, everybody. So just a few comments to add on build upon what Mr Secretary has said. Clearly great focus on the FDA had come tomorrow and then and then a week from tomorrow reviewing the fighter and then the modern vaccines. Probably most of you have now had a chance to look into the fighters. Submission. I’ll be happy. Thio Address any questions you may have there with quite remarkable FXC, I think. Very good safety profile, mostly injection site and injection related adverse events. One of the points I’d like to attract your attention attention to is the captain Mayor curve That shows that within 12 days or so from the first dose of vaccine, the number of cases in the study vaccine arm flattens and continue to remain flat after the second does. But the key point is already after the first dose, and if you study the misogynistic data, you’ll see that there is barely detectable neutralizing antibodies at that time. There is already very, very significant protection induced. I think it’s very important because hopefully we will start impacting people’s lives very quickly after the onset off the campaigns to immunize. And secondly, it’s something that makes us very mawr, uh, optimistic. In regard of the young since Vaccine J and J that, as you know, is being tested as one. Those vaccine, probably in a few days, the Moderna booklet will be published and you will see that the data are as as impressive and compelling regarding the J and J vaccine. But I said it’s a one shot vaccine. Actually, there is a There is a second face retrial that has a two shots vaccine. But what we consider to be a breakthrough in terms of intervention into the pandemic could be the one shot vaccine where optimistic efficacy could be very high. We have already recruited more than 38,000 subjects in this study we jnj. We decided to cap the recruitment to around 40,000 subjects, which will happen by the end of this week in the next 23 days, and given the attack rate into the city and in the countries where the city has been conducted, it is very likely that we will have our first views on FXC for this vaccine very early in the month of January and that somewhere in the late of the month of January or early February anyway would be submitted and hopefully approved swiftly. We may be able to accumulate another 30 to 40 million vaccines in the month of February if this vaccine gets approved and an equivalent number or slightly higher going forward in the month of March, etcetera. So important thanks to keep in mind, uh, in terms of impact on the on the pandemic. Also the AstraZeneca vaccine. We have now about 18,000 subjects recruited in the U. S. Conducted face retrial That’s under the oversight off Operation War speed. There are no different dosages. There’s no different batches of vaccine. That study, we believe, is going to give a clear outcome as to the efficacy and safety of the vaccine on. We again look forward to potentially reading out from that study on its efficacy somewhere late in the month of January and if positive anyway, maybe filed somewhere in late in the month off February with final analysis data on the protein vaccine side, which is the third platform technology. As you know, that we have in the portfolio. We have very good progress with Novavax that is gearing up Thio start its face retrial and we have some further analysis ongoing and discussions with Sanofi Thio. See what the next steps in progressing the vaccine. They’re towards phase three, so things are moving in the right direction on Happy to address your questions and pass on to my coup leader general partner to tell you more about how these vaccines are gonna make it into people. Thank you, Dr Slowly. And Mr Secretary. Thank you. Eso uh, you know, just exciting time to be in the business that we’re in right now. Uh, supporting this through logistics and eventual sustainment. Uh, vaccine distribution, uh, and resupply accordingly. So, uh, we are focused on our micro planning A to the state jurisdiction level, uh, reminder of the triad that’s involved in this. The C d. C. Experts who developed the strategy who have been working day to day with states for the last six months. Um, the commercial industry partners, McKesson, FedEx, ups, uh, Walgreen, CVS, and many others who are working their plans every day to make them better. And then, of course, the states right, our ability to enable their priorities on their plans is what really will determine our success. Every day that goes by, we get stronger on this, but eventually, right, we’re going toe, have a new way, right not to get out in front of that decision. But to be prepared for it. Uh, this week, This past Friday, all the jurisdictions, all 64 jurisdictions and five federal agencies locked in their micro plans for the Pfizer vaccine. So based on their, uh, their allocation of vaccine, which we provided to them, we locked in 636 locations by quantity vaccine delivery if and when the vaccine is approved a zai I’ve talked about, we will begin, um, upon approval of the U A. Packing to the micro plans and district begin distribution within 24 hours out to the jurist addictions. Accordingly, our goal is to make sure that we can ensure the vaccine is delivered on in a timely manner is delivered safely securely on. It’s ready to be utilized to start administering, uh, vaccine as soon as possible. To that end, what we also already did I gave permission toe already distribute syringes and needles. Alcohol wipes on dilute, which is required in support of the Pfizer vaccine, will begin that today. It will be distribution will be completed by Friday again on Lee to set conditions. And if it sits there for another week or 10 days or whatever, then it does, but planning for success, We wanted to make sure that the states had all that they needed toe have, um, this week, Uh, we’re focusing not on Lee on the final, Uh, uh, planning for the Pfizer vaccine, But we’re in deep coordination for the micro plans for the modern A vaccine. So last night, final lock of allocations were provided to the jurisdictions. Uh, today, tomorrow and Friday they will lock in locations and quantities and hence will be prepared for follow on, uh, eventual approval of the EU way for Madonna. So great news in the planning world. Really confident, uh, in the collaboration by the CDC with states by the continuous improvement by commercial industry on then the states knowledge and execution of their plans, we continue Thio have conversations with the public health officials across the country. Right? We’re personally talking to them, uh, neither briefing governors with Secretary a czar and Dr Slowey or we are making phone calls individually to governors. But more importantly, helping the health experts who advise governors on their plans, You know, in the army, we call this battlefield circulation to assess you know where everybody is to help focus toe add enablers if required to fine tune etcetera on DSO. We’re working this virtual circulation with everybody very powerful sessions that it’s allowing us to identify things ahead of time. Several calls, you know, I’ve said, General, they’ve said, General, we’d like you to consider something. Absolutely. That’s why we’re calling CDCs up on the phone, commercial industries on the phone, that states are on the phone and we’re solving problems ahead of execution. Does this mean perfection? No plan is only good to get you started. What is important is the open communication and collaboration between the triad to sustain, to develop plans, get ahead of problems and be ready to execute really, really appreciate those phone calls collectively by everybody. Finally, we’re working on education materials for the vaccine. C. D. C. Is doing excellent work they’ve already posted on their Web page. Significant education, uh, information and tools for the Pfizer vaccine on how toe work through it. It will be updated based on FDA guidance on and the A sip guidance, right? So it’s not the conclusion yet, but it’s allowing people to get involved and start to really see things, so they’re not learning things at the last minute, right? Everything that’s admissible to be provided is being sent out on will be updated accordingly. Really, really important. Piece toe what we’re doing. So, at the end of the day, I’m very excited about where we’re at. If you’re in my profession and you’re not excited, you ought to be doing something else. I feel confident that we’ve done uh, detailed planning. We worked through rehearsals. We have checked. What if Fox on? We continue to learn every day in preparation for eventual distribution. Mr. Secretary. Great. Thank you, General. Thank you, Doctor. Doctor Slowey and Michael, if you wanna get us started on questions from the media. Thank you, sir. Thank you all. Operator. We will now open it up for questions and a friendly reminder that when asking a question, please state your name and publication and keep your questions short as possible so we can get to as many questions as we can in the time that we have and I’ll turn it over to you know Operator? Yes, thank you. If you would like to ask a question, please Press star one, I’ll meet your phone and record your name and outlet. Clearly, if you need to withdraw your question, please Dial Star Thio again to ask a question, please Dial Star one. Our first question comes from Kevin Brown from Fox News. Kevin, your line is open. Good afternoon. It’s it’s Evan Brown. Thank you so much. Um, uh, two questions there really quickly. The U K. Has reported ah, few cases of people having an allergic reaction, and they’re advising some people who know they might have allergic reactions to not get the vaccine. Is there a similar request or order that would come from American authorities on this? Telling people Hey, you should not get this vaccine. And second of all, when does a you A, uh, evolve into, um, or permanent approval for either these vaccines or any vaccines in general? Great. Evan, let me answer the second question, and then I’ll pass it to Dr Slowly to speak about the British incident that’s been reported so in terms of, uh, E way versus the full biologic license is called a B L. A. This is actually a fairly unique circumstance here because the FDA has through there you a guidance on covert vaccines actually required a very high standard of data on safety. Efficacy and manufacturing compared actually tow what the statute requires for emergency use authorization. They’re effectively holding these vaccines very close to the evidentiary standard required for a biologic license. So, for instance, each clinical trials required to have 30,000 people in it. That’s extremely large for a vaccine clinical trial. They’re requiring 60 days of safety data from the median patient visit. 90% of adverse events with the vaccine usually occur within the 1st 42 days. All of the statistical significance requirements for efficacy are the same that they would have been for a full license so up everything I just laid out there is what a manufacturer would have done for a full on license. There really are two principal differences between an emergency authorization, as we’ll be seeing here potentially versus the full biologic license. One is long term safety that, of course of necessity you don’t have years of data of safety information with A with a normal product going through the system because you wouldn’t have had operation warp speed doing commercial manufacturing at the same time as the developed development process you would have had them time for ongoing safety monitoring before you ever had. Vaccine released here will have extremely aggressive what’s called Phar Maco Vigilance Program, which is part of what General Purna and the CDC have orchestrated with our states to very aggressively monitor as more and more people are vaccinated for any type of safety signals, safety events, etcetera. So that’s part of that. But again, 60 days of patient visit data 90% of adverse events and vaccines, usually with the 1st 42 days so well within that window. The second is really around manufacturing. Obviously, the FDA for emergency use authorization will be validating manufacturing quality to ensure consistency of product from what was done in the clinical trials to what’s used in commercial scale for a full on biologic license. They actually will run. Try a lots in the manufacturing facility under FDA inspection that tends to take another several months after what now you a would be that comes out. So be thinking approximately four orm or months after the U A. Issues that the products might be subject to a full on final biologic license. But now Dr Slow, we have certainly correct me is the expert on vaccine development if I if there’s anything you want to correct on that front But then on the UK issue, please. I were a spot on Mr Secretary regarding the allergic reactions. Uh, our understanding is two health care workers who were known to have severe allergic reactions in the sense that they had both EpiPens on them and they carry them all the time. So that tells me they are known to have severe allergic reactions, have had what has bean terms and an F electorate reaction, which which is a systemic as well as local reaction but not life threatening. And they probably, I assume that I don’t know, for a fact injected themselves with the EpiPen and therefore the reaction resolved, uh, looking into the data patients or subjects with severe allergic reaction history have been excluded from the clinical trials, which is classic. So my expectation is that this is new news. Uh, and I would assume, but of course, the FDA will make those decisions that tomorrow this will be part of the consideration. And as in the UK, the expectation would be the subjects with known severe reaction. Allergic reactions should not take the vaccine until we understand exactly what happened here. Great. Thank you. We could turn to the next question, please. Our next question comes from Sarah over mall from Politico. Sarah, your line is open. Thank you. Um, I wanted to ask about states allocations of vaccines. Um, General partner said that those were just finalized. Um, why did certain allocations decreased before they’re finalized? And then, um according to this Wall Street Journal article that was breaking down the expected allocations. Um, organs getting roughly the same amount of Alaska when they have six times the population. So it’s just done based on population. Why are there numbers like that, General? Okay, so just, uh, maybe a refresher. Uh, we’re allocating, uh, by, uh, by population a pro rata to the available vaccine. When I snapped the chalk line, vaccine comes off through manufacturing to fill finish, Um, Onley. When I’m confident that it’s been approved for final distribution, does it count, uh, for us to distribute? When I snap the chalk line on that number, then what we do is we take the pro rata population of above 18 years old. We allocate that number, and hence we develop allocations to all the jurisdictions and five federal agencies accordingly. So an example. The Pfizer vaccine on Lee had x amount available that was approved for distribution when I snapped the chalk line two weeks ago because I wanted the state’s toe have time to do micro planning to that number. A week later, when we were talking about allocating to Madonna, there was a different amount available on I snapped the chalk line. We did the way, did the formula and hence they have a different allocation. It will bounce back and forth week the week based on availability of vaccines that are approved for distribution. But are formula for distribution remains the same. The states will then prioritize inside of the E u A FDA, you a guidance and the CDC uh, a sip Guidance on. They will figure out what groups to prioritized inside of that, I think. Good. Yeah. Next question, please. Our next question comes from Angelika Angelika. Excuse me, Angelica. Live Edo from Bloomberg News. Angelica, your line is open. Thank you for taking my question. When will operation warp speed publicize the state and jurisdiction allocations And if it does not plan to publicize these, why not, General? So right now we way publicized the allocations by state to the states. Right? And so every state has their allocation, uh, two for the distribution of Pfizer and Madonna. Uh, that is a working number that we need to utilize the for our planning and execution it is based on, as I articulated the pro rata to the population. Uh, and distribution is fair and equitable to everybody. A to this time I’m on lee, uh, sharing those allocations with states so that they could do their micro planning. And we can ensure a good, constant flow of vaccine, uh, to the entire, uh, United States of America. Thank you. Next question, please. Our next question comes from Katie Thomas from The New York Times. Katie, your line is open. I just wondered what the total estimate is for how many millions of doses will go out that first week. Is it still 6.4 million? So 646.4 million is where I snapped the chalk line. Right? Because that was available at the time. You know, over two weeks ago on then what we did is I pulled some off for some reserve good Army General officer planning, right, So that we make sure that in case we, uh, need to react to some situation we had some reserve on. Then I split the remaining doses, which was six million doses in half on. Then we did the allocations accordingly. Our plan is to distribute the first dose to the American people based on allocation on then 21 days for Pfizer. Later, we’ll ship the second dose on eventually for Madonna. It’ll be 28 days later but snapped the chalk line. 6.4 pulled off some reserve divided in half distributed. The first half will distribute when you is approved. That is the method that we’re using, uh, for the initial distributions. Eventually, we will become much more confident in our manufacturing, our distribution process, state handling, etcetera. And then the requirement for reserve won’t be necessary. A total amount that I’m pulling off now. Thank you. Next question. Our next question comes from Kansas. Story from AP. Candace, your line is open. Hey, thanks for taking the questions. Can you give an update on the status of the data use agreements, whether those final a handful of jurisdictions have signed off on them. And then secondly, as more vaccines come online, how are you planning for scenarios where people might hold out for a particular vaccine, For example, everyone wanting the J J one shot vaccine and leaving providers with stockpiles of two dose vaccine, Why don’t you start off general? Then we’ll turn to Dr Slowly for the second question. So, uh, first one D e U S, um, 64 jurisdictions Reminder 50 states, eight territories, five are six metropolitan cities as well as five federal agencies were down to our last three. Uh, in fact, we’re in communications with three states right now, and we think we’ll have them completed today. Or tomorrow is what I was briefed this morning. Feel very good about that. I have personally talked to all three, uh, states about this, and I feel good about it. Um, thank you. Yeah. So it’s a It’s an important question. The answer to which can only be conceptual until we actually know the performance off the off the next vaccine. Now what the criteria to be taken into account are the actual efficacy level that the vaccine has. I hope that most vaccines that we will have will be in the high eighties or 90%. There’s a there’s a there’s a a perception associated with that that’s important and not to be neglected. But if there if there was a gray agent on efficacy, I think it would make sense to give the highest FXC vaccine to those who have the highest morbidity and mortality from the disease and the slightly lower efficacy. If that was to be the case, toe more healthy, younger population, I think the second point is the actual, Asai said. The performance, the performance of the vaccine in terms off safety profile vaccine with MAWR um acceptable react to Dennis ity would need to go into populations that have the higher benefit so again, those that have more severe disease consequences. And the vaccine that is milder may need to go into ah, lower risk population and then, frankly, pragmatism, which is those availability? The way we designed our strategy has been to give ourselves the opportunity to have different vaccines with different performance on the one hand and spread our risk in case some of them fail or are delayed. But secondly, to accumulate vaccine, Those is faster than with just one supplier by having different vaccines, a community, different doses through different manufacturing sites. Thank you. Next question. Our next question comes from Graham. For Deano from Buzzfeed Graham, your line is open. Hi. Its dander Ghana with blood seed news. Um, I have two questions, I guess one for Dr Slowly. Which is how would you compare the side effect profiles you’re seeing in the Pfizer Moderna numbers to other vaccines that people might take that you’ve seen maybe the flu vaccine and others. The second thing is, maybe for general partner or secretary is our I’m really just urging you to create a dashboard with the distribution numbers, not just keeping the state’s reassure people. That’s been very helpful to all of us in the news business. Not really a question. Just an observation. Thank you for that. And, uh, the feedback on the dashboard question and I’ll work with General turn on looking at that Dr. Slow. Right. So I would say the vaccine that has the closer, uh, local reactor, ethnicity and systemic reactor Jenness ity. I used the word reactor Jenness ity Not the word safety because, frankly, safety, it’s all the same and they’re all safe. But the vaccines with similar local and systemic reacted unity, which is injection site tenderness, redness, pain, headache, a little bit of fever, all of the above, resolving within 24 to 36 hours for immunization, about 10 15%. Having what’s called Great Tree, which is not the maximum great great for is the maximum. But greater is significant, clearly noticeable 10 15%. So the vaccine that’s closest to that is shin Greeks, another vaccine with very, very high efficacy. Probably there’s no free lunch. If you have a very good immune response, you notice it. But it’s not a safety issue. It zits actually an immuno dynasty marker, uh, and shingles. As I understand Shing Greeks a zai understand is, uh it’s so effective and enormously used to the extent that the competitors vaccine has been withdrawn from the market with no issues whatsoever. Thank you. Next question, please. Our next question comes from Carlo Donald from Reuters News. Carl, your line is open. Uh, Carlo Donald from Reuters. Um, just just curious. With vaccine doses like begin being administered soon. Do you guys have a plan for? You know who will receive that? That first vaccine that’s gonna be done publicly if you have any sense of where that does will be administered or you know what? What type of personal will see that a health care worker frontline work or something like that? Just curious if you have any. Any planning on that? Well, now you make me feel as if we should. Uh, General, we’ve been so focused on speed, getting it out, deferring to the governor’s way have been deferring to the governors, and we’ve been deferring to the jurisdictions in the cities. And so we probably do need to, uh, make make a plan for you know who’s gonna get it first. Visibly, a secretary a czar said Dr. Slowly said, I apologize. I’m putting words on. I’ve said we’re all gonna be available if it’s appropriate. A time to be, uh, receive the shot. And we’re all more than comfortable of getting it. Um, you know, on TV, etcetera. But we wanna work through, um, you know, fair and equitable distribution and the decisions by the governors, the territories, and, you know the mayors of cities accordingly on. And it’s just an important balance of not, uh, showing favoritism, but making sure that the people that you know a sip has identified get the vaccine first in their priorities. Six. A za general mentioned I’ve I’ve made clear to the team is I’ve made clear publicly to the media and otherwise that I will gladly get the 1st, 1st 1st shot first vaccination. Just demonstrate the American people might supreme confidence in the integrity of the process, the quality of the vaccines and that I wouldn’t ask the American people to do something that I wouldn’t be willing to do myself right? Next question, please. Our next question comes from John Collins from Science magazine. John, your line is open. Thanks for taking my call. I just wanted to clarify something about the fighter vaccine that Dr Slowey said. I don’t think you were implying that people should just get one dose, so I just wanted to clarify that point on. The second question I have is about the data coming from Russia on from China of efficacy in press releases. But if they were to apply for us from three FDA and were to receive them with the U. S. Government purchased those vaccine and distribute them. When there’s a shortage of supply of other vaccine, I will answer the second question, then turned the doctor slowly about the dosage. Uh, anybody is welcome if they’re subject to an i. N. D. Under the FDA is clinical trial practices of conducted their research consistent with the human subject. Research protection laws of the United States and relevant treaties to submit their data to apply for registration for emergency use, authorization or biologic license with the Food and Drug Administration, where it would receive full consideration. But that would require, as the FDA is demonstrating out by consideration of the Pfizer and Madonna vaccine. Complete and utter transparency and availability of all data related to the clinical trials and support to remember the FDA is looking under the hood literally examining every line of data every patient, every patient identified in their, uh, toe look through and confirm the quality of the data. Eso they’re open for business, but you have to comply with our rules to protect patient safety. Start slowly. Yeah, I think it’s a really important point, they said. secretary because that is one of the comparing or most important rationales off the time it’s taking. The FDA actually goes back into the road data and re analyzes the data rather than interpret a table, for instance, it’s out there not suggesting anybody else has done something wrong. I’m just describing how the FDA does it. And John, thank you very much for asking for that clarification. I’m absolutely not suggesting that the vaccine should be a one does vaccine, because the observation off that high efficacy was only over a period off, uh, actually 10, 8 days or nine days in the case of fighter, and is only over a period of three weeks. Maybe. In the case of Moderna, it’s very encouraging to say, superfast onset of protection. The second those is a full part of the label. If the vaccines are approved, it consolidates the immunity to to the into the patient’s against covered 19. And that’s the data that shows long lasting, at least over a few months, immunity and unexpected to be very long lasting. But so people should not take the vaccine as a one does vaccine. We do have the young sense vaccine that is being tested as a one. Those vaccine where the follow up will be long enough to assess that we’re not observing in a micro event, but rather, uh, long term. One could ask the question. Why not run? FXC tries with the one Does vaccine of the Modern A vaccine or the fighter vaccine? That would be a valid question. Off course. Timing would be a big challenge. Dr. Slaughter could actually interjected and asked a follow up question. Because I get this one from the media a lot. I think it be helpful to have your perspective there. The question often comes up with the Pfizer 21 days Madonna, 28 days to the second booster shot that one would get. How precise is that on the 21 or 28 days when a patient comes back? If they were to come say the 22nd day, 23rd. Obviously want everyone is close to that is the prescribed days is possible. But could you describe for the media just interactions there? So there are there is the regulatory answer, and there is a scientific, uh, observations. I think the regulatory answer is a vaccine is approved on a 0 21 days or 0 28 days. And that’s what should be done. Now, what does the science say around that? That precision is not that important. What we know with many other vaccines is that the more you space, the two doses of vaccine, the better immune response to get after the second dose. But the trade off is that you have a weaker, potentially weaker protection between the two doses. So when you’re dealing with the disease that has low incidence, that’s okay, because your risk of contracting it is low in between the doses. So, for instance, 06 months is better than 02 months is better than 01 months is probably slightly better than 0 21 days. But, uh, if there is a significant transmission of disease, as is the case here, we should absolutely get the second does exactly as has been studied. Great. Thank you very much. Thank you. Next question, please. Our next question comes from Islam. Ahmed, from a sp, Your line is open. Hi. Thank you so much for doing that. Um, Dr Sorry. I was wondering what you made off the in the vaccine on the data that showed the four cases off Bell’s palsy. Is that something Thio Watch out for Moving forward is how concerned are you about that? Potentially or at all? On the second question, Waas Um, are we fairly confident at this time that we will see an immune, uh, memory B cell response on so that the immune system will mount antibodies further on down the line? Or do we just don’t know that yet? Thank you. So I think the first question on on safeties, whichever are the serious adverse events of interest of which policy would be one. For instance, on the Pfizer strategy as it’s now public, there are three active farmer provisions observation studies, UH, one the classic farmer conditions where physicians or subjects patients called back into the company one that uses the V A and the Department of Defense data sets on subjects immunized, and one, an active health care worker focused. 20,000 subjects follow up city over three years that will detect, uh, any significant adverse events. I think here a large number and long term follow up is the key and the capacity to compare to an appropriate baseline is the other key and frankly, the appropriate baseline ISS, slightly challenging in the sense that it’s a new baseline, because the pandemic itself has changed the baseline frequency of a number of events into the population over the last 10 months. So it’s very important to take a recent, almost concomitant baseline. As to the memory question. All the data generated with messenger on a vaccine in small animals and large animal and with other vaccines that I’m very familiar with, as I was on the board of Moderna before, is very clear that you establish a very robust, long lasting memory response also assessed by detecting memory cells and, importantly, looking at the Ricoh response, the Global and ISA types all the markers needed to tell you have a robust ISA response, and you have a robust memory response. And I think this vaccines, therefore will have long term memory and the protection induced after one. Those in the presence well, in the absence of detective neutralizing antibodies, in my view, is another demonstration that this vaccine best way to protect against this vaccine disease is actually really a faster kinetic immune response. It’s a race between speed of replication of the virus and the speed of the immune response mounting. If you are old, have a weak immune system and your immune response is slow. It will be very intense, but it’s slow by the time it intensifies. You have a lot of our slowed. Have lots offset infected. You are in trouble. If you’re immune responses fast, you’re asymptomatic or you’re just totally cleared. And I think that’s what we’ll way would hypothesize will be established in most people. Immunized his memory That gives a faster immune response and therefore long lasting protection. Okay. Thank you. Next question, please. Do we have another question? Yes. Um my apologies. The next question comes from John Hosie, Bloomberg News. Hi. Thanks. Can you just clarify, um, on the numbers and initial shipments going out? So we have it. Right? Um, it sounds like of the six point 4,000,005, their doses 400,000 will be held in reserve, and then half of the remaining six will be held for a second dose reserve. So three million initial stop, uh, will go out in the first round and then is the goal still have 20 million people vaccinated in December. So the the answer to the second question is we believe that there’s there will be enough vaccine available for 20 million first vaccinations in the month of December. Let me ask General Tornado on the actual precise numbers from the first distribution Trump s. O. E rounded into the question. So I apologize. So a 6.4, I pulled 500,000 for the reserve on. Then I divided the remaining, which meant 2.9, uh, initial first dose and 2.9 2nd dose. Uh, I apologize. I did round for the for the response to the question three exact number is 6.4 pulled 500,000. 2.9 1st. Those 2.9 2nd does. Okay. Next question, please. Mhm. The next question is from Tom Powell, Washington Times Tom, go ahead. Hi, Tom Howell with The Washington Times. We talked about how the recent fighter data show there was protection after the first dose. It sounds like you’re still planning the whole back Half the dose is to ensure supply. But has there been any late breaking consideration of just giving all the initial doses and then hoping that Pfizer ramps up its manufacturing in time, Uh, have it available within a reasonable amount of time, especially given what Dr Slowly said about how it doesn’t have to be exactly 21 days or, you know, for that second dose. Thanks. Yes. So, Tom, thanks. And I’ll ask the general of the doctor toe. Please add any color commentary on this. But, um, because the EU applications and hence the label from the FDA would likely, we assume, include both the first dose, followed by the second dose. Uh, we do believe whether from a held back reserve or from ongoing expected production of vaccine, we believe there needs to be, in our mind unavailable dose for that second administration of the vaccine. So we have done calculations of both what we’re getting now, what we expect to get now and what the production lines show should be coming. And that’s built into our forecast of what we believe we need to hold back. And as the general said, is, we get more experience on quality control on the production. We’ll get greater confidence, of course, in the level of supply reserve we hold back for that second dose administration. But we will not distributed vaccine knowing that the booster will not be available either from reserve supply by us or from ongoing expected predicted production. And we’re already working with manufacturers to maximize the full scale of their production. So that’s built into our forecasts. I first I completely agree. I never suggested we should take a one. Those vaccine. I did specifically say the trade off when you space is you, may your protection may go down. It would be, I think, a mist ake unacceptable mistake to knowingly distribute the vaccine in non respect of the label. That would actually, I think, Dr the hesitation around the use of the vaccine high. So at least as an operation, there’s never something we would recommend should be done. We need to comply with how the vaccines were tested and be optimally used. I think the second point is that unfortunately, the mathematics are misleading. The numbers we share with you our monthly numbers 40 million this month, 50 million next month. But that’s not how life happens. Life happens is the 14 million this month is two million. This week, five million next week. Three million the week after seven million the week after. And therefore it’s not Bullis. It’s a rolling number. And therefore, if we were the only way I can tell you, we played the the mathematics and the modeling of that for a whole week because there is. There is almost an ethical question there that we wanted to make sure. What’s the trade off? And the trade off is about 1 to 1.5 million people vaccinated with the risk off. Not giving the second does knowingly to people at the time they should have received it. And we decided that’s not a risk we should take. Maybe, maybe by the middle of the amount of January or early February, when we have had 56 weeks of rolling hi cadence manufacturing and that we see that you know, things are rolling perfectly. We may and I did say it in other settings. I have never in 30 years seen the launch of a new product without having built up a stock before in industry, and there’s a reason why industry takes that financial hit. It’s because we always know, particularly with biologicals, things could happen doesn’t mean they will happen, but they could happen and therefore you build a stock. In this case, we have a pandemic. We need to people save people’s life. We’re gonna roll vaccine those as they come, but we’re not certain they will come exactly as per plan. And as we said, you know, biologic protein manufacturing it it can be as much art form as it is science. And Dr Slowly, I think you’ve used the phrase before that, uh, that proteins or moody and we have to be very careful on production. That’s really been one of the core elements of operation Warp speed. I think really one of the genius elements behind it was moving from clinical trial lot size production to commercial scale production early on in the development period, through the logistics, manufacturing and financial heft that we’ve been able to bring to the table to try to actually get there. Because there are often so many failures in the normal commercial bio pharma industry in that move, from clinical trial scale to commercial scale exercise, the system, get that done but still be cautious, especially in the early weeks and months of vaccine distribution because quality control issues, sterility issues. They happen in biologic manufacturer. If I if I couldn’t secretary, just add two points to that. And I agree wholeheartedly with both comments. One, I use the term snap the chalk line. You know, it is about ensuring that the number that we allocate against allows the jurisdictions to do the detailed planning on the locations and the quantity they want sent to those locations, right? So that we sure efficient and effective distribution and eventual use of the vaccine. The second point, I would tell everybody, is if your plan is based on perfection, I, Congar Inti, you execution will not equal perfection. So you have thio put things in place to mitigate, uh, where you’re vulnerable and to allow us to, you know, adjust and make sure that everybody who gets there first those could get their second dose. We have time for one last question. Okay? The last question comes from Rebecca Robins, New York Times. Rebecca, your line is open. Thank you for taking my question. My question pertains Thio the nursing home effort by CVS and Walgreen. Could you tell me when that will begin? Or if the first shipment in the first allocations that states will be making. We’ll be going exclusively to hospitals and health care centers and whether the nursing home effort what will start later? Thank you, general. Sure s O. I just want Thio really applaud the great work by the C D. C uh, CVS, Walgreens and states in this effort. Right? We, uh, roughly six weeks ago, maybe two months ago, I brought it as a course of action to them to prioritize, figure out a solution that could be implemented nationally. Um, that would best service, uh, provide support to these facilities on. I would tell you I received incredible updates on I’m excited about the plan. Number two, a zoo. We’ve talked about the plan we’re implementing the states plans to their priorities. Uh, eso their determination of I would like it to go to the health care or long term health care facilities has to be identified first. As many as 36 states have already told the C D. C. A zm I update this morning that they want initial, uh, dosage to go to long term health care facilities. Uh, the CDC, Walgreens and CVS are working those plans. Uh, right now, the third thing is is that it is a not as easily, uh executed as easily said the amount of work that has to be done in collaboration and coordination with the actual sites, right, understanding the patients that air. They’re making sure that all people are briefed and notified and people that care for those people are notified. All that collaboration has to occur, making sure the right sites, uh, to administer inside of the facilities already on that coordination. But that detail work has been done on. We’re going to be ready to implement when the first wave goes out in accordance with state plans over great Well, um, to the member of the media. I hope you are finding these weekly briefings helpful. We intend to continue them. I also hope yesterday that you were able to watch the vaccine distribution summit meeting where you got to hear from leaders at CVS and Walgreens talking about their plans on nursing homes, but also more general retail distribution and how we’re leveraging the normal vaccine and flu flu vaccine distribution systems that we have to get to hear from the’s great logistics and distribution companies. McKesson FedEx ups who literally showed you the materials they’re using to shipping McKesson, showing the actual kits that they put together in our direction of PP syringes, needles deal. You want to be able to administer vaccine and getting to hear from some of the great governors about how detailed the micro distribution planning has been at the state level. Working with General Pernis team in the C. D. C. To make that happen, I just hope you will assist us in getting word out to the American people so that they could have a high degree of confidence. As General Purna and each of those corporate leaders said, we’re leveraging what already works every year in our system to distribute and vaccinate hundreds of millions of vaccinations every year, using the tried and true, using the systems that we know work. Or as they all said, this is what we do leverage that don’t try to build something new and different. We have enough. We have enough variables on execution that we’re managing through this cove it pandemic. Use the tried and true there, and I hope you’ll help us with getting the word out to. People will have confidence that our military 100 are states or governors or private sector. They know how to do this. They’ll get this job done, so thank you all very much and have a good rest of week that concludes today’s briefing. Please send any follow up questions to our press office at media at HHS dot gov and have a good rest of the day.