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tv   Members of Operation Warp Speed Hold News Conference on Vaccine Distribution  CSPAN  December 16, 2020 11:17am-12:00pm EST

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indiscernible] secretary azar: that process, you went -- vaccine, something hat pharmacists, pharmacies -- [indiscernible] >> following the tour, h.h.s. secretary azar joined other members of operation warp speed for a news conference on covid-19 vaccine distribution. the first americans received the vaccine earlier this week.
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secretary azar: good morning, everyone. thank you for joining this operation warp speed update today. we continue to have good news to report. as of today, shipments of vaccines will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments. i hope that every american has been as heartened as so many of us at h.h.s. and d.o.d. have been to see heroic health care workers and vulnerable americans getting vaccinated this week. i had the chance to see this work firsthand myself at two sites, at george washington university hospital, and this morning at medstar georgetown university hospital. what i took away from those visits is this, while operation warp speed's delivery of vaccines on this time frame is extraordinary, administering these vaccines can feel quite ordinary. at g.w. they were administering vaccines just like they do any other vaccines, but with all the
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appropriate social distancing precautions. at georgetown this morning, the director of pharmacy, jeff cox, showed me the pfizer packaging that he had received, showed me the g.p.s. tracking and the cold chain storage tracking devices that connect directly in to the general's command center where every single pfizer box is trapped and monitored on temperature control for excursions. and he showed me the cold storage facilities. and he walked me through, very simple that youing, mixing, and extraction process. he said, other than that this is covid, this is pretty standard. this is what we do. and that's been the message from virtually every partner that we are working with in this endeavor. every hospital, fedex, u.p.s., c.v.s., walgreens.
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this is what we do. we have a great deal of work in the coming months to get a vaccine to every american who wants one, but we are confident in our approach to using the health care providers and institutions like hospitals and pharmacies that do such a good job of providing tens of millions of vaccines to americans every year. for next week, we have allocated another approximately two million doses of pfizer's vaccine for jurisdictions to use. and if moderna's vaccine is authorized by the f.d.a. in the coming days, we have allocated nearly 5.9 million doses of that product. as many of you know, on tuesday the f.d.a. released the analysis that we'll use to brief the independent advisory committee meeting tomorrow. the agency concluded the vaccine is 94.5% effective in reduces the incidents of covid-19 among the treated group, which far exceeds the standard f.d.a. has set forth for emergency use authorization. and they concluded that the vaccine is safe.
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if and when the moderna vaccine is authorized, it will have gone through the same rigorous proceedures that the pfizer vaccine did and every other vaccine receiving authorization will go through. that includes critical trials -- clinical trials, much larger than many vaccine trials, independent data safety and monitoring board that oversees those trials. the drug companies' own ethical standards and checks and balances. the f.d.a.'s independent and transparent advisory committee meeting. the f.d.a.'s transparent guidance standards for emergency use authorizations for covid vaccines. finally the f.d.a.'s career scientific experts applying the standards that they have publicly shared. we have been heartened to see that americans' vaccine confidence is rising substantially. according to an abc poll this week, more than eight in 10 americans say they plan to take the vaccine. kaiser today announced 70%. vaccine confidence is surging.
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we still have much work to do to ensure all americans understand the value of these safety and effective vaccines, but it's clear that many americans are learning these vaccines are safe and extraordinarily effective. and as we get more and more health care workers or vulnerable seniors vaccinated and they go through the experiences i was able to see with health care workers this morning from doctors, nurses, e.r., labor, deliverry, i.c.u.'s alt medstar georgetown university hospital, i asked each of them getting vaccinated how it felt? every single one of them said i didn't feel it as much as i feel the flu vaccine shot. and had good experiences. as the word gets out, as they talk to their friends, colleagues, their neighbors, vaccine confidence in the united states will just increase by word of mouth, by trusted sources every single day. finally, i want to remind americans that there are two authorized antibody treatments that operation warp speed has
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supported that can actually help prevent hospitalizations in those patients with the highest risk for severe disease. those are individuals 65 and above, and individuals who have could he morbid conditions that put them at risk of hospitalization from covid. if you test positive and you fit in those categories, please speak to your health care providers immediately because the best time to get those antibodies is not when you show up in the emergency room but soon after being diagnosed with covid. we have allocated over 330,000 doses of these treatments to all states and territories. many states do have product available, even as we have people entering into the hospital with covid. so, again, if you have tested positive for covid-19 and at risk for severe disease based on age, weight, underlying health conditions, or a loved one who may fall into that category, there may be an option that could help keep you out of the
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hospital. please talk to your health care providers. i want to note another success we announced yesterday that fruits of the public-private partnerships we built to expand testing. yesterday the f.d.a. issued an emergency use authorization for the first fully at-home diagnostic test for covid-19 that does not require a prescription. this product was developed by alum with $30 million in support from the n.i.h. rad-x program the diagnostics arm operation warp speed. they have invested nearly half a billion dollars in not only development of breakthrough testing options but expanding the production of these options. the test will cost about $30 and the company expects to be able to make millions per month in the coming year. even with the emergence of these new tools, we are not at the finish line yet. especially as we approach the holidays.
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and in the coming months we have all got to continue taking steps to keep ourselves, loved ones, and community safe. the three w's. wash your hands, watch your distance, wear your face conversation when you can't watch your distance, and avoid settings where you let your guard down and not do those things like overcrowded you restaurants and bars, and especially those household gatherings that get multiple household together friends and neighbors, you eat, drink, you let your guard down, you think because you know people they can't be infected. you can't infect them. you are not symtomatic. this is how the disease is spreading right now. this is what's leading to cases which lead to hospitalizations and tragically leading to fatalities. we have the tools in our hands right now. to bridge, to the days that are upon us we used to say bridge to the weeks and months ahead. it's bridging to the days that are right upon us now. but we all have to act responsibly and we'll get there. because as we look to next week
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and the ongoing holiday season, my goal is for everybody that's here now to be here next year for the holiday season thanks to the vaccines and therapeutics that the heroes of operation warp speed and america's biopharmaceutical industry are bringing to you. you have to make it to that point through responsible behaviors to get to the moment when you can get vaccinated w that said let me turn things over to the doctor for a scientific and development update. >> thank you, mr. secretary. hello, everybody. briefly, i hope you had a chance look into the moderna submission and the f.d.a. comments. i think they underline and demonstrate again how effective these vaccines are, and also describe very clearly they are very good safety profile. just want to highlight two things.
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look at the curves and effects after the first dose, 10 to 14 days after the first dose. it doesn't mean this is a one-dose vaccine because people got their second dose two weeks later. it means onset of efficacy is very fast after immunization and we should start to see an impact in the very high-risk populations without being immunized. the second thing is the apparent protection against infection as detected by p.c.r. detection of virus on day 28 in the population that has shown anywhere between 60% to 65% protection which is exciting. after one dose. we see that data coming up after second dose in the next few weeks based more on the sir logical end point than biological end point, that will be very helpful from a public
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health perspective. i expect the protection to be quite significant. it may not be as long lasting as the protection against disease would be. finally, on moderna, as you have seen in their announcement, 20 million doses will be delivered by the end of the month and i ex-- really reilly excellent. pfizer wants to remind you we are working closely with the company to help them address all the challenges in continuing to increase their capacity and output and also at the same time discussing how we may come to an agreement on the first option for an additional 100 million doses. next in the portfolio is the johnson & johnson vaccine. tomorrow we will close recruitment in the phase three trial with about 43,000 to
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44,000 subjects recruited. really an outstanding performance in terms of the volunteers which we warmly thank for their generous participation into the trial. the trial is accruing cases very quickly. we hope that we may be able to assess efficacy first time early january, maybe a final time late in january. we just had this morning yet another meaning to discuss the supply chain and how we can optimize availability of vaccine doses even faster than they were thinking early on given the speed of the clinical trial development and have vaccine doses in february and march already impacting the u.s. population. we are very hopeful there. on astrazeneca, we are about 23,000 subject recruited in the phase three trial.
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we expect that trial to come to mostly its completion in terms of recruitment by the end of this year, or very early in january. and case accrue again during the month of january with or without . february also continuing to ogress on the supply chain with accumulation already stockpiling of vaccine doses. the two protein vaccines also continue to progress. u have seen the announcement some delay with the phase three trial plans. and the novavax is on the starting blocks towards phase three trials. timely, i'd like to just close on the therapeutics. we are supporting four programs, priority programs. the eli lilly antibody, as well as the cocktail program.
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we have ensured access to 950,000 doses. it's being shipped very significantly. mr. secretary just gave you the numbers there. likewise, with regeneron we have an agreement and secured access to 300,000 doses of the cocktail . and we are discussing additional access to additional doses. likewise with eli lilly. astrazeneca we have an agreement where they are testing their very long half life antibodies as prophylactic medicines. either in subjects that's very high risk of acquiring the infection and the phase three trial has started, already recruited 300 subjects and currently as planned review of safety by the date safety
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monitoring board before further recruitment in the trial goes on. also in a post exposure profe -- scies trial where people profe lackcies trial where people are suspected of incue late bathing the virus are treated to prevent their progression into infection and disease. is the fourth program merck partnership program. very important to treat patients in more advanced stages of disease with very significant impact and the analysis of their phase three trial. exciting, frankly progress there, but on the other hand as expressed by myself and mr. secretary yesterday, disappointing level of usage of the therapies in the hospital setting with patients infected but not hospitalized. we really hope to see a much,
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much higher level of usage of the doses that are delivered to the health care facilities. where our surveys for now, they are not yet fully complete, they show anywhere between 5% and 20%, which for hospital preventing and therefore lifesaving intervention in this setting is not acceptable. we look forward to that improving. on that i will stop and pass on to my co-leader, the general. >> thank you, mr. secretary, thank you as always. very exciting week albeit only the third day, workday of the week, just really a lot of good things occurring as we execute the initial shipments that went out. i would tell the team -- everybody listening we have been able to watch the whole process from beginning to end. partnered with pfizer. we had senior leaders collaborating with their senior
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leaders literally on the floor as they were packing and getting ready to distribute boxes this weekend to actual loading of the trucks. really just excellent collaboration between o.w.s. and pfizer. very impressed with the teamwork there. then we extended it through security of the shipments with the u.s. marshals and their track, coordination of handoffs, down to fedex, u.p.s., and down to the final administration sites where we dropped off the vaccine where the c.d.c. dispersed people throughout the country to observe the receipt of the product. to just get lessons learned and learn how it's being received. the comfort of people receiving it. how they unload the box. how they go ahead review instructions and initiate execution of administration. we have been seeing it all over the news. people getting doses of vaccine
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he really a remarkable end to end effort. easily said, very difficult to do. and i'm grateful for everybody that's been a part of that, because as we get going, we want to learn lessons rapidly improve everything we are doing so that every expand distribution day, every week, every month to the american people n that light, as we talked about earlier this week, we are, and the secretary just highlighted, we are on track with all the deliveries we said we were doing. the volume was 145 on monday. 425 yesterday. and 66 today. so that was our get out of the gate, get going, see ourselves, learn a lot. tomorrow we are going to be at 886 deliveries. we are going to 886 additional locations in the united states.
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it is about a steady drumbeat cadence of deliver riff vaccine out to the american' -- deliffry of vaccine out to the -- delivery of vaccine out to the american people. i want to highlight one point with two examples. we can see everything from manufacturing through distribution down to administration sites when it comes to what's happening with the vaccine. two points i want to highlight. we had two trays of pfizer vaccine that arrived in california in two separate places. as we were tracking the temperature, we noted that the temperature actually got colder than minus 80. went to minus 92. we locked those trays down. pfizer and o.w.s. working with fedex and u.p.s., they never left the truck. and we returned them immediately back to pfizer and we sent immediate shipments to replace
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those two trays. we are working with the f.d.a. now, c.d.c., f.d.a., and pfizer to determine if that anomaly is safe or not. but we were taking no chances and we could see that. the second example all wait on the other side of the country in alabama, two trays were received at one location same anomaly. it went to 92, minus 92. again, we were able to stop and quarantine the vaccine. get a replacement shipment immediately to alabama. now we are just working through the forensics to determine if the vaccine is still good, etc., etc. learning. the key is we could see ourself and we were able to take action. i applaud pfizer, really remarkable effort. fedex and u.p.s. and the participation of that. those are the types of lessons we are working our way through. as the secretary talked about, last night we allocated up to
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two million doses of vaccine for pfizer out to the jurisdictions. they are working through their planning and where they want that vaccine to go and those deliveries will start on monday, tuesday, wednesday for deliveries. it's a constant flow of vaccine always expanding the distribution network in every state that we are really going for. we are continuing our efforts as we talked about on monday with the long-term health care facilities. i would tell you, ohio and connecticut are all set underneath the c.d.c. federal program to begin long-term health care facilities on friday and saturday, as we said. this week really great effort to start our scale up. we know that florida and west virginia are also -- have started long-term health care facilities utilizing e.m.t.'s and/or another contractor as the
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states decided. the point being is we are already doing long-term health care facilities. and come monday, we will be over 1,100 different locations starting long-term health care facilities. that will rapidly expand thousands a day into our process. over 70,000 facilities that we have coordinated with and that we are working the plan for distribution. c.v.s. and walgreens are leading this effort in collaboration with the c.d.c. we are really aggressively working on the offense to take care of these great americans in these facilities. really, i'm very, very excited about where we are going with that and will continue to report on that accordingly. as we talked briefly about -- what is next? i just talked about some tactical execution of the
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delivery, but we are already expanding our thoughts to vaccine dosages becoming more and more available as we are more confident with the manufacturing and distribution. so what do we want to be able to enable next? the c.d.c. and 19 pharmacy chains are collaborating. i received a very extensive briefing on saturday. i participated in the call with the 19 pharmacies and the c.d.c. they have established and are working through the final details to enable governor plans about allowing access to all these facilities throughout our country. in simple terms, when -- as soon as we can turn the key on on this, we are looking sometime about mid january as doses really become available but won't be locked to one date. it will be driven by states' decisions and vaccine
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availability. what we see is an expansion of capacity for administration of vaccines up to about 37,000 brick and mortar facilities. this is really just a powerful collaboration with the pharmacies and the c.d.c., but most importantly enabling the vernors' plans to expand vaccination throughout their states as we transition to other really critical groups. really excited about that and we'll keep you updated as we go forward on that. the last thing i would tell you, it's not lost on you if you have heard me talk before, this is the beginning. it was a great start, but every day we have to hold ourselves accountable to very high standards. we have to continue to learn. we have to just get better every day. because at the end of the day it
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is about safe and effective vaccines and therapeutics for the american people. i would leave you with this. it's a whole of america approach. it's being illuminated through the states' plannings and execution as you saw. really want to give them kudos for the elaborate work and execution accordingly. i will again re-emphasize as the secretary mentioned the reason why we are so confident in what we are doing, we have the professionals executing it. whether it's pfizer and hopefully moderna shortly, but really fedex and u.p.s. right down through the pharmacies is what's giving us the confidence because they do this every day. and they are demonstrating the professionalism and their organizational culture in execution. the high standards and the accountability that they are accepting. yesterday i had a phone call
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with wes wheeler from u.p.s. and richard smith from fedex, the two c.e.o.'s. both of them were ensuring me as as we were looking at the weather maps for today in the northeast and later in the week for the northwest, how were we going to mitigate and continue the flow of vaccines? these two leaders knew exactly the weather report. they had people planning, mitigating strategies for distribution and they were making contact with customers establishing rules saying that if somebody's not there because of the weather, even though they are there, we retain the vaccine. it goes back, secure, and delivered the next day. that's what these two leaders and their companies are involved in. i assured them that i would underwrite a leader's decision in the delivery of the vaccine to ensure driver, pilot safety, and safety of the vaccine i said
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leaders, you make the call, i will underwrite the distribution accordingly. i was so impressed by their ability to see themselves, make mitigating plans, and hold themselves accountable that i'm here talking about it today. i just wanted to pass to the american people. the last thing i would tell you, as we are working through things, we are not stopping. you heard dr. slaoui about where we are at with continuing to bring additional vaccines to bear. hopefully jensen and astrazeneca, but we are also working inside our manufacturing facilities to expand capacity every day. a slaoui and i visited company working to expand their capability. the secretary was just there yesterday or the other day. yesterday. between our visit, and the secretary's visit, which has
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been about 10 days, we were able to get the army corps of engineers there to help them assess, participate, and help really work through ideas to expand capacity more rapidly so we could get more doses of vaccine more rapidly. we actually think this is going to come to fruition and we'll have more vaccine from potentially once it's done for moderna. we are always constantly trying to expand and rapidly increase the availability of safe and effective vaccine for the american people. mr. secretary, that concludes my comments. secretary azar: thank you, general. we are open for questions. michael. >> we'll open it up for questions. a reminder when asking please state your name and publication and keep your questions as short as possible so we can get to as many as we can. we'll turn it over to you now, operator. >> thank you. if you would like to ask a question, pleas press start one
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and record your name. if you need to withdraw your question, press star 2, announce your name and outlet before asking your question. our first questions comes from mara with fox. your line is now open. eporter: a reporter at fox. for the doctor and general, could you provide context as to the scale of this endeavor compared to other vaccination efforts in the past compared to say smallpox, he polio, or annual influenza vaccinations, how much bigger and faster is this effort to roll out covid-19 vaccine? what is the relevant metric to compare this to? dr. slaoui: if we talk about vaccination, every year in the u.s. between 80 million and 100 million of doses of flu vaccines are distributed. and therefore we are talking out something that's maybe
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three or four times bigger. over a period that's probably similar, six months, because the flu vaccines are distributed from the month of august to the month of december. i would say the distribution aspect and the immunization aspect i think are not very significantly different. that's the reason why use the existing capabilities and resources is the appropriate and the right thing to do. that's why our level of confidence is very significant. of course extreme of that, in terms of discovering, developing, manufacturing the vaccine it's been dramatically faster, but again not by cutting any corners. but rather by using judgment in terms of which vaccines to go after and how to test them and running everything, and taking the financial and operational risk but not any -- cutting any
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corners. up to now it's been productive. general perna: the other difference, just for context, is influenza is ordered. so based on orders from hospitals, doctors' offices, pharmacies that is what industry produces and is a very timetable associated with the distribution, as dr. slaoui just talked about. in this case what we are doing with the covid vaccine, we are pushing. we are coming up with availability, then we are distributing based on allocations. it's a pull versus a push. which makes planning and execution a little bit more difficult, as i said the states have really transitioned well on this. their leadership is well involved. that's why we are having so much
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success. >> next question, please. >> our next question comes from sarah murray with crncrfpblet your line is now open. reporter: hi. thank you guys very much for doing the call. one of my questions is, now we are going to see a broader distribution effort around the moderna vaccine, assuming that's authorized, can you give us a better sense of what kinds of locations the vaccine will be headed to that we haven't seen from the pfizer vaccine? just a follow on that, we are hearing concerns from states about the timetable turn around of when they are getting the allocations to when they need to figure out where these need to go. has there been any consideration about that timetable? secretary azar: i'll turn it over to general perna about the moderna question, but just so you know, we have -- the vice president convenience a regular call with governor -- convenes a
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regular call with governors usually on monday, and general perna and i gave an update on vaccine distribution as we have been doing for the last couple months with the nation's governors. we got some really good feedback on the last call. addressing exactly the question you are raising. as you know we had been setting up the allocations on friday to ship on sunday or ship over the weekend, then the following monday, tuesday, wednesday. and the request from the governors was a bit more time on that. that's why you heard general perna say he switched the cadence to tuesday night. tuesday night, snap the chalk line. and tell them their allocations so they can have several more days of planning for us to initiate the shipping for the following week. general, on that or the moderna shipping locations, anything? general perna: mr. secretary, you nailed t it was a great feedback by the governors and their ability to have more time. what we did, our goal is to get
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all available doses of vaccine out to the american people, as we have talked about. and so just had to facilitate and update to understand exactly what we thought was going to be releasable. then i could snap the chalk line. my thing is, normal repetition from now forward, pfizer vaccine allocations will be on tuesday nights. if e.u.a. is approved for moderna, they'll be included in the tuesday night allocation. then states can just order based on their allocations accordingly. i think a great effort there. reference moderna locations. i would tell you you are going to see a lot of the similar capability and capacity, delivered to the same types of capability and capacity. it will start to expand out to rural-type areas, i believe as i remember reflecting on plans, and there will be more
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allocations towards nursing homes and execution of that. nursing home and long-term health care facilities. current, primary hospitals still included. i think you'll see more expansion of the moderna vaccine. remember, because of when the planning and what was available, we were able to spend out more moderna on the first dose than the we were able to send out on pfizer. almost double. >> next question, please. > the next question comes from carda with associated press. your line is now open. reporter: thank you for doing these calls. ricardo with associated press. my question s. could you please provide an update on negotiations with pfizer for additional doses of their vaccine.
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when would that be available? and can you provide some insight on the earlier decision to decline the option to purchase more pfizer vaccine, how will this impact the cadence of general perna talks about. the cadence of delivery? secretary azar: thank you, ricardo. obviously we have to be careful. we are engaged in active negotiations on procurement matters. there is only so much we are able to discuss with you. just as we have said public we are in active discussion was pfizer about exercising additional options under our contract. the core issue, as it was on the initial question, there has been so much misunderstanding out there, is pfizer's ability to manufacture by a date concern. we are working -- certain. we are working with them to provide them assistance. now they have identified some of their production challenges that they've got, we have been working with them on what assistance is appropriate for us to provide in order for us to
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secure additional doses. we are working towards additional doses for that secretary quarter. right now they are producing at their maximum capacity to deliver on the 100 million that is in the first tranche of the contract with us. we are providing manufacturing support as we have really from the beginning with pfizer. it's important to understand the pfizer relationship, while it is very much part of operation warp speed, is a different contractual relationship than the other five vaccine manufacturers. on the other five we are more intimately engaged in the support of the development and manufacturing of their product on an ongoing basis. whereas the relationship that pfizer wanted with operation warp speed was the guaranteed purchase of vaccine if approved by the f.d.a. and that means that to date we have had less visibility into their manufacturing processes.
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their manufacturing capacities, their locations, and supplies, raw materials, supply chain management than we do with say a moderna or astrazeneca or johnson & johnson. part of our ongoing discussions is to remediate that and get better visibility into what they are doing, what challenges they are facing because they basically give commitments to us and others in their manufacturing. as you know, they ended up coming short, half of what they thought they would be able to produce nouns they would be able to produce in the year 2020. general or doctor, could you give any additional perspective, maybe talk particularly about this misunder-- miss understanding out there about the addition -- misunderstanding out there about the additional options. dr. slaoui: i think any reasonable person would understand we built the portfolio of vaccines and took them into development in order
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to ensure that, a, one of them at least makes it to the finish line. and b, if more than one makes it to the finish line, that we can accrue and accumulate vaccine doses faster than if we were relying on a single provider. frankly, i hope once and for all it wouldn't make sense whatsoever to preorder more from one vaccine manufacturer than any other one before we know a vaccine works. i don't know what rationale drives people to ask that question. you wouldn't buy something before you knew it works if you had six opportunities to have one provider provide you with what you needed. number one. number two, in order to ensure that we would be in a position to acquire more vaccine doses if and when a vaccine had first signs of performance, we built
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options in each and every one of our agreement. that's the right thing to do. that's the thoughtful way to allocate resources and taxpayers' money. as soon as we knew that the vaccine works, the negotiations started and i think the secretary really described the nature of the partnership that we have with different companies. some are more arms length. and others are extremely onp hold. when pfizer was unable to specify when vaccine doses would be delivered, we don't need 100 million doses of vaccines starting in september or december of 2020. 20201. we need them in the second quarter. if they make it into the second quarter. if they don't, i think there are enough vaccine doses, as you could see, through the first option agreement with moderna,
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now doubling the amount of vaccine doses we have, and with the johnson vaccine coming in and as tra seneca -- astrazeneca after it. i think the strategy's really happening exactly the way we planned it. and we, of course, would welcome having another 100 million doses of the pfizer vaccine. we are negotiating with them appropriately. our expectation is for that to complete shortly. secretary azar: we have time for two more questions. general perna: i'm very good with that. secretary azar: ricardo, it keeps getting asked over and over again. we'll keep answering it. we have 900 million doses of vaccine we have contracted for the delivery of. we have options that increase that to a total of three billion doses of vaccine. have 100 million of moderna
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set between now and march 31. 100 million of pfizer between now and march 31. 100 million additional moderna in the second quarter. we are working actively with pfizer. i will just say i'm very optimistic that we will conclude a successful result there. have johnson & johnson with 100 million in active production, single dose. so that is 100 million people right there. astrazeneca, i believe it's 300 million on astrazeneca. >> you can finish watching this at we'll leave here to fulfill our 40-plus year commitment to congressional conching. -- coverage. the u.s. house about to gavel in. first up, speeches, legislative work starts at 2:00 p.m. eastern. six bills on the calendar today.


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