tv HHS Secretary Azar Officals Provide Update on COVID-19 Vaccines CSPAN November 18, 2020 11:01pm-11:57pm EST
a.m., medical experts on outpatient andtments for covid-19 ascendant homeland security meeting. >> up next, health and human services secretary provides an update on covid-19 vaccine development and distribution. he was joined by other officials who outlined the process for safely storing and getting the vaccines to those who need them. this is close to one hour. >> hello everyone, thank you for joining this update on operation warp speed. because of president trump's ofnding and leadership operation warp speed, even as we face daunting trends around the --ntry, we have transferred reason for optimism.
we have now to safe and highly effective vaccines that could be authorized by the food and drug administration to be distributed within weeks. number of ways. operation warp speed has delivered a safe vaccine in a number of ways. and ensure there are no delays in vaccine production. because of this work, by the end of december, we expect to have 40 million doses of these two vaccines available for distribution pending f.d.a. distribution and going to our most vulnerable americans. we have been laying the groundwork in administration for months. there are four major caps to get
the manufactured product to americans safely in order to save lives. allocation, distribution, administration and ongoing monitoring and data work. we have led the groundwork for these and paid for the vaccines and worked to ensure that the administration costs will be covered by private insurers through medicare and medicaid for the ungin insured so american. we procured supplies like needles and personal protective equipment and assembled into kits that will pair up into supplies.
this path is a partnership between the federal government including operation warp speed and the c.d.c. and the 64, state, hole and agencies. for allocation, the c.d.c. is highly respected long standing advisory community will make recommendations to the director about how to prioritize populations for distribution of scares vaccine and will be allocating them on a proratea population basis. then the federal government will have a contract one of the world's leading distributors of pharmaceutical products to ship the product from manufacturing
sites to where the jurisdictions decides where it needs to go. we have been working closely where it needs to be shipped and administered and submitted to c.d.c. to review. shipped and administered and submitted to c.d.c. to review. we have done a great deal of work to support jurisdictions this these efforts. last week, we reached agreements to allow administration by pharmacy chains to cover more han 60% of the pharmacy. states can have the products shipped to these for administration. they live within five miles so vaccinations is easy access once they are approved to the general public. using pharmacy networks beyond
tand alone pharmacists and technicians provide vaccinations nd get a covid-19 vaccine as convenient. this complements the agreements with walgreens to offer them in nursing homes which presents special challenges. we have seen tremendous uptake of that option already. 99% of skilled nursing facilities have signed up and 100% of facilities in 20 states have signed up. finally, while any vaccine distributed will have gone through months of safety testing, we are working with jurisdictions to ensure they are enrolled in the information technology infrastructure that we need to monitor for any potential safety issues.
as i said, we have reasons for optimism. thanks to the incredible public servants working on operation warp speed and elsewhere at h.h.s., and thanks to president trump's unwavering support of operation warp speed we have a bright future ahead of us. we have good news on vaccines. we face daunting trends in the virus. right now is not the time for anyone to let their guard down. we continue to encourage americans to follow the three w's, wash your hands, watch your distance, wear your face coverings and avoid settings where you can't do those settings. as we look to thanks giving, i ask you to look at the state and local governments about how gatherings can be made as safe
as possible. the safest way to celebrate thanksgiving is at home with the people you live with and through virtual and gathering is a higher risk activity. please know there is light at the end of the tunnel and because of the sacrifices and the hard work so many have done, we will celebrate with family and friends not so far in the future. i want to hand things over to the doctor to discuss more about the vaccine development and production and then to the general to discuss in much more detail the distribution plans as they stand now. we anticipate having regular briefings of this kind for the media to ensure that you have full visibility into our vaccine and therapeutic programs as well as our distribution planning in
cooperation with the states. cooperation with the states. >> able to be so far along. how did this affect you. what we have done is to leverage the decades of discovery and research that was done in identifying and optimizing like cassette players. or make vaccines against different viruses and cassette players to put in them the
covid-19 information and played that music as well as people ever hoped, both in terms of their performance and in terms of their capacity to manufacture at large scale. and took financial rsks in large clinical trials before we know whether these vaccines would be effective or not. the trials are about two, three, four times larminger than what is required. and we were able to accrue cases faster by having more people
into the trial. but the other reason we have done that by running larger trials, we are able to document higher confidence in their confidence. here we are a few months, seven, eight months with two vaccines that have achieved 95%. they will be be filing. and if approved we have already started to stockpile that same dose as the secretary has said to the tune of about 40 million by the end of the month of december and equivalent on the monthly basis going forward to start immunizing the u.s.
population that need the vaccine. now, let me say a few words about the safety of these vaccines. we run larger trials than required and we have a pretty good understanding and description of what i would call the short-term safety of these vaccines during the period of their clinical assessment. this period is shorter than usual, which what he are doing. things.e doing is two we analyze the f.d.a. over the last four decades. when, in time, these vaccines appear and there are tens and tens of vaccines that have been developed and receive over 90% of those side effects occur within the 40 days after completing the immunization schedule. schedule. of the 60 days on 50%
population in the clinical trials before we can consider approving these vaccines. we cover the overwhelming majority of potential side effects where we understand the performance of the vaccine from that standpoint already now. secondly, we are working with the f.d.a. and c.d.c. to set up together a very, very high performance that are resembles to the day the assessment that we do in clinical trials to look at the safety of the trials in the population as the am immunizations rolled out if the vaccines are approved and on a daily basis and as soon as signals will appear. and it is important that we were
able to accelerate the vaccine to the extent we have done. s you know we have 150,000 people infected and thousands of people dying every day and waiting two or four more months and the hundreds and thousands of more deaths the harm to the population that no vaccine would even approach in decades or centuries. we we believe the vaccines will ve the effsi and we look forward to the receive views with the receive views and potentially approve these vaccines and -- [indiscernible] >> would recommend immunization. and then we look forward to the
next two vaccines that will be giving us data in weeks to come, early january for one of them and for the other, it could be this the next few weeks if data f trial is for the u.s. or later. thank you very much. and i pass now to the co-leader with me. >> mr. secretary and doctor, my co-leader, thank you for this opportunity to focus on distribution. so, first, i will say this is a large task, but it's a task that we are up for and we shall going to take a whole of america approach and why we will be able to do this and working on this six months. since the announcement on may 15, we started planning
accordingly and it is the foundation of our planning started with the great experts at the c.d.c. and extended to the injured of planners so we have a great collaborative plan on how to execute this together and as the secretary talked bout earlier, we have im plemented several mechanisms to allow other organizations inside of america to unable execution one ot one source or organization will be responsible but it's the collective group of us that will make this successful. distribution of the vaccine will be based on fair and equitable of the population. population of the state against available vaccine will be
distributed to each state. we are -- excuse me, we have been working, these numbers with the states for a little while and every week that goes by, we are able to create a tighter shot group of the actual numbers and the allocations thabe available to each state as we get going. distribution will be by jurisdiction, as i talked about -- i use jurisdiction in states. sometimes inappropriately. let me define jurisdiction, 64 of them. 50 states, eighth territories and six metropolitan cities equal the 64. we are doing extensive planning with each of these organizations so we implement their plan. so they will figure out where we want the vaccine to be distributed to and add minimum
terd and where the vaccine will be distributed accordingly. we will emphasize following f.d.a. guidelines, the governors and the states will figure out the plan and we are ready to execute in collaboration with their plan as we have been working on for six months, doing numerous table-top exercises and rehearsals to move the product to distribution centers to actual administration sites. we are making sure, as i said, it is a wheel of america approach. clearly here in health and human services, the c.d.c., our experts know how to distribute ack convenience as they do every very or the influensa and
talented group of people who know all the technical as pebts and requirements to make sure that the vaccine once we have it filled finished, we can distribute in a safe and effective way. the second step is 100% collaboration with the jurisdictions making thur that we are integrated and ready to implement their plan for the way they want to skite immunization down at the sites as they define it and ready to do it because we have been working together for a while. c.d.c. had jurisdictions filling out the playbook and collaborating and working the plan to make sure that every detail is covered.
second, we are working with commercial industry, the experts in this field, those that know how to produce, store, distribute and administer the vaccine accordingly. they do this every day. this is the united states of america. this is not new to us. so organizations starting with pfizer and moderna, who know how finish and begin distribution of the vaccine, it's their core competency and working with a large, very large distribution company that knows how to distribute vaccine throughout the entire country and i'll talk about that in a minute. as the secretary mentioned, we have collaborated with phrma such as c.v.s. and walgreens and
we have laid out plans and coordinated memoranda of agreements to make sure we are executing in the right way in accord answer with the right plans. we are bringing this whole of america approach from government to industry and make sure that afe and secure vaccines. the time associated with delivery. we will begin distribution of the vaccine within 24 hours after emergency use authorization is approved. and only after the science has determined and approved it accordingly, then we are poised and ready to begin distribution. distribution will occur from our finished sites and go to 64 jurisdictions that we are
responsible to make sure they get vaccines within 24 hours. so every jurisdiction will have access immediately. upon the initial push of vaccine which is the quantity of vaccines that are available upon the emergency use authorization, then we will begin a weekly delivery of vaccine. as it comes off the shelf and becomes available for distribution, we will distribute it to the 64 jurisdictions. so, initial push and then continuous cadens of vaccine to make sure we rapidly expand availability to the entire country at the same time. we are working with jurisdictions to do several things that we need to make sure that we get done as we get closer to final approval at the e.u.a. by the f.d.a. three things we are working with
the jurisdictions we need to have. first, we must have jurisdictions create good solid expansive provider enrollment. as mr organizations as they want, need to be enrolled so we can expand distribution rapidly to the quantities of vaccine that is available. only to providers that are enrolled can we distribute to, so they can limit it to a certain amount or expand it so we are covering the entire country as the secretary alluded to. very key point. we have made significant progress in this area. we are just counting the inches of enrollments that we have to get done as we get closer and closer. second, we must have the states go through and sign their data use agreements.
this is incredibly important for the new vaccine going out to the american people. first, we must be able to see ho got the first dose and what vaccine. why? we must ensure to do the same for the second dose. the second thing and really important is we want to make sure that we have a good, consistent flow of vaccine out to the american people. so our ability to track the uptake and the actual administration shot in the arm is essential to us making sure we deliver a vaccine on a continuous basis. so really important. the third thing that i would the jurisdictions working on, the rehearsals in the execution of their plan. we conduct table top levels.
all of government and industry and jurisdictions participate. but then we are expanding it now o actual execution down to the tactical levels. how do we work distribution of vaccine through the c.v.s., wall green, at the hospital. how does it get received, unloaded, stored and administered is the rehearsals we are working. i continually talk about this. it is a great mechanism to check and double-check to make sure everything is in place. what we are doing to make sure that we are ready this level working in details the last several months, two things we must have. one, upon emergency use
authorization, all of america must receive a vaccine within 24 hours. this is important. tear and equitable distribution of the vaccine throughout the country at the same time. it is an equitable distribution and we are driving hard to make sure that happens. the second thing we want to do is make sure that the cadens of deliver is route teen that ates can plan for it and account and develop execution so that the population is well informed and that they know where to get the vaccine and when to get the vaccine and until those two points we are driving home as key essential tasks at our level. so, mr. secretary, thank you. and i pause.
secretary azar: as i get ready for questions. i express my deep appreciation to the doctor and the general. when i created operation warp speed, i called around to people in the industry and everybody said the person that you need leading this is the doctor, the world's leading vaccine developer with the greatest track record of tg delivering results and has proven that. i met with the chairman of the joint chiefs and immediately said the person you need leading this effort is the general. nd the american people owe a deep gratitude as well as the hundreds of people on their teams who are delivering the kinds of results that we have seen in the last week. we'll turn now to questions.
>> thank you, operator. we can now open it up for questions. >> if >> zachary brennan, you can state your outlet. reporter: i am with politico. i'm curious if someone could talk about plans for vaccine waste? forou are trying to provide -- for thethe plan remaining doses that might be left over after delivery? sec. azar: let me ask general perna. have been working hard with the jurisdictions to
make sure that the plan provides details to that end. you mentioned that pfizer comes in a package of 975 doses per tray. modernity comes in at 100 doses per trade. that is only a constraint because of what we have to do to maintain it at a right temperature for stability. you can break down both vaccines. you can pull out quantities of what you want to execute and normalthem from 2-8, refrigeration and execute them within five days. that is the key. , the the planning specified execution that we are counting on. these states have been working this. one of the reasons that we asked and brought walgreens and cvs in is because they know how to break this down and do small
quantities for importing groups. we worked very detailed plans with them. we are collaborating that with the jurisdictions to make sure that no vaccine is wasted and wet when they go to immunize -- when they go to immunize, they have the right techniques and procedures to make sure that only the required doses are reduced to the right temperature for administration and that the others stay in the appropriate to preserve for stability. >> thank you next question. >> thank you, the next question comes from ebben brown please state your outlet i would. reporter: evan brown, from fox news. there has been a lot of talk from the need every should -- of refrigerating the pfizer vaccine at an extremely low-temperature. are there plans to either
provide more these refrigeration units to either retail pharmacies or health care facilities, is there a way, thinking back to earlier this year, the ability to ramp up production on things like ventilators. is there way to ramp up production, to build for these refrigeration units to get to where they need to be? sec. azar: i will ask general perna to continue on this question. either yourself or dr. slaoui to get out there the latest information that we have on temperature stability on the moderna vaccine and the pfizer vaccine. i think that will be an important technical clarification for people. and the cold storage on pfizer. laid outa: dr. slaoui for us very incredibly well. i would say that both the pfizer vaccine and the maternal vaccine
, these vaccines are ready to be administered. ,hat i have been coaching jurisdictions, is do not be afraid of the constraints because of the vaccine and to temperature requirements. we have walk through every individual step on how to maintain pfizer vaccine with ultracold refrigeration, as well as what it needs if it is maintained in the box that it is delivered in, via drive ice. with excruciating detail. we know where all the ultracold theage refrigeration is in country. we ask the jurisdictions months ago for this data. they went, identified, tracked it down. they were also provided with resources on how to go buy more refrigeration if they wanted to, to increase the distribution capability throughout their jurisdiction, if it was required.
not requiredo additional refrigeration. they have enough. and/or, how did they supplement with dry ice as accordingly? we laid it all out. my message, do not be afraid of the refrigeration requirements. the capability exists. if more is needed, the capability exists to have it purchased and delivered in a timely manner for both refrigeration and dry ice. and then i think -- think keeping the vaccine refrigerated, when they are anred in mass, it is not issue, as they generally just explain. it is important that once you throw them, and the maternal vaccine, you can keep that for 30 days. for the moderna vaccine. vial has 10 doses of vaccine.
that is enough time to immunize 10 individuals. vaccine, you can keep it for five days, ample time to immunize. comfortable that there will be minimal wastage. every thing is planned to the minute. i am learning about how the army wins wars. it is impressive. >> thank you, next question. you may you, beth long, go ahead and please state your outlet. beth longthank you, with inside health policy. i'm wondering if both of these euaines both getting clearance around the time. how will it be determines who gets which vaccine if they are both available, and how much of
the population to expect will need to get vaccinated in order to achieve widespread immunity? >> dr. slaoui, you can start with that. we are fortunate to have two vaccines that have about identical performance. it will all depend on the reviews by the fda and the minutia of the data, exactly what is labeled and the safety profile. and are very similar, they're making and in their performance. therefore, i do not think that there should be in a constraint on who gets what vaccine. i think that one in the hand is better than two in the bush. i.t. willd the ac make the call. in regard to your second point, each level efficacy is very impressive. it needs to be complemented. efficacy against disease.
we need to, and we will, be able to assess capacity of these vaccines also helped prevent infection. if there is infection, whether they impact the amount of virus a load that sheds, to which we infect other people. most lovely, they are effective against infection. maybe not at 95%. and most likely they are effective to decreasing virus load. so they should have an impact on transmission. model, anything north of 70% of the population being immunized should decrease substantially the pressure of the virus circulating, and therefore substantially achieve herd immunity. add to that, we are ready to distribute both approval and eua
fair and equitable this omission manner that i discussed earlier. we are ready to simultaneously it to ship both to all jurisdictions. >> thank you, next question. >> carol o'donnell, please state your outlet. reporter: hi this is carl donald. of voting on, kind what has been asked. vaccineoresee madera's in more prevalent and being more quantities and other hard-to-reach areas given its constrainingess storage requirement. you've received their appear to time for only the pfizer vaccine is available, given the timing of the eua.
as dr. slough about earlier, we will wait for the science the lay things out for us. and then will execute the plan that the jurisdictions have established. once they figure out their priorities and where they want it to go. i will tell you that we worked excruciatingly details to ensure that every area is being thought about, whether it be inner-city or extreme rural areas, so that we have the capability and capacity to do so. again, the connection is our ability to partner with the industry, both distribution and pharma for administration to really achieve that success. sec. azar: that is partly why when the cdc and the distribution team worked with the 64 jurisdictions, we gave them two hypothetical vaccines
with these types of profiles described on them. vaccinera and pfizer profiles, so there with her think about which outlets they want to use and designate for us to have them shipped to, that they would fit those kind of profiles. i think that it is built into their jurisdictional planning. regard to her? the two vaccines being available. we are probably talking about a week or 10 days. as the fda reviews the files. whether they would hold one or two. the lag time between the two vaccines would be very minimum. sec. azar: next question. >> stephanie, you may go ahead. ebbs, from abc news. can you walk us from more details about what might happen between 24 hours between a
shipment and do anticipate that the committee would meet and determine recommendations for how to prioritize that initial shipment of doses before goes out to state or after? excellent that is an question. i am working directly with cdc director robert redfield on how to intervene -- how to convene it concurrent with the fda review. customarily, they wait until there is licensing from the fda, and then 48 hours later we will meet and provide advice out. we are looking to see if we can facilitate a current review process that is collaborative with the fda sharing whatever ration -- whatever information they need. over 1000 people perishing per day, our mission at operation warp speed is about saving lives every hour. everyday matters.
where going to work to minimize any delay there. next question. >> you may go ahead, please state your outlet. tom howells from the. in whatgive us a sense time of storage would be in different settings echo there are freezers, refrigeration's. dry eyes, thermal shippers. which kind of places will be using which? large chain pharmacies, have resorted is not? mostly hospitals and universities and the pharma chains had the ultracold storage capacity. it ranges from different volumes of capacity, maintaining hundreds of thousands of doses to just limited to 81 or two trays. as i said, we have those pen throughout the country. how they are fitting
into the jurisdiction plans for distribution. what we have done to really help mitigate the distribution of that vaccine outside of ultracold storage availability is partner with pharma, in particular cvs and walgreens who have mobile capability for both toracold as well as how distribute out of the pharma, excuse me, out of the pfizer distribution boxes that contain dry ice. they are well constructed on how to manage the dry ice to ensure that the spill of the vaccine remains the same throughout distribution. to that end, the second point, we are partnering with the states and jurisdictions and pharma to ensure that the plan, based on how many doses that we
have, that we distribute initially, through the cadence, what is the word that i want to use. we want to lead our way through execution. distribution will be through organization that allows people to be notified and be ready for the administration of a shot, at least initially through what may be december or january timeframe, until we have more vaccines that will be available through his many different locations. sec. azar: next question. >> you may go ahead, please state your outlet. reporter: peter from the wall street journal. what steps are you taking to ensure that this whole process continues to go smoothly in the transition to the next administration? in the eventter, of a transition, the individuals that you are saying here, other than myself, all of the
individuals involved on the operation warp speed are career officials. they are not impacted by a change in leadership. the work with the state is deeply embedded with cdc's work processes. transition, of a total continuity occurs. sec. azar: next question. >> emily cox, you may go ahead. reporter: hi, this is emily cox. secretary azar, there is a cnn report that suggests that if they hear from anyone with president-elect joe biden team that they are not to communicate with them. i wanted to get your response to that. and i wanted to ask, i have heard a lot today about the role of the 64 individual jurisdictions. are you encouraging the vice president, or the president
elect to reach out to those individual jurisdictions to find out the plans in loot of more meaningful collaboration at the federal level? sec. azar: we have made it very clear that when a determination ensure, we will complete, cooperative transitions and planning. we follow the guidance. about getting therapeutics and vaccines admitted in getting the clinical trials done and saving lives. that is where our focus is as we go forward with our efforts. >> we have time for two more questions. >> thank you. charles fishman, you may go ahead. please state your outlet. reporter: charles fishman with atlantic. a two-part question about dry ice. can you tell us about how many of the places receiving the vaccine have the altar quote freezers and how many rely on
dry eyes, just as a percentage? how this issue works [indiscernible] how would you provide to the places that need dry ice the first recharge? can you tell us how you're going to do that? ice going to dry come from, and how will it get to the people who need it the day that the vaccine arrives echo ? gen. perna: i do not see any place for the vaccine will be delivered that it would not go to an ultracold refrigerator. as we are dealing with the initial dose is available and distributing accordingly. asked the jurisdictions to plan for to go right into that capability so that we can learn and transition to gather, as we expand doses available to each of the jurisdictions.
initially, i believe the all will go into ultracold storage refrigeration. the second point to your question about the dry ice, we did, and we have coordinated and contracted for the first refresh of dry ice to all that we distribute if it is required. if it goes into the ultracold storage like i said, then it is not required. but there are surely to be exceptions, as we work through every detail across 64 jurisdictions from the pacific all the way to the northeast. anddown to the southeast back up to the northwest. there will be an exception, and i wanted to make sure that we were ready for that. we have coordinated. commercial industry, for dry ice production, we have coordinated through them as well as in particular through pfizer to
help with this, and the distribution will be through fedex and ups. i feel very confident in that plan. sec. azar: i think we have time for one last question. from afp. my question is, this approval seems like a matter of a couple of weeks away now, what does that mean for those of phase three trials and how to go about collecting data? approved, people obviously what to get the actual vaccine. affect how we increase the scientific information echo ? does it move on to phase four?
dr. slaoui: this is an important question. thank you for asking it. unfortunately, the rate of transmission in the country is such that as pfizer, for instance has already reached the final analysis numbers and announced today, it is very likely that moderna will also certainly -- shortly attending that number. from the standpoint of efficacy analysis, the trials will have achieved their objective. long-termtandpoint of follow-up into the trials, the trials could still generate substantially important information, such as persistence of protection over time and safety over time. in that regard, we are working with the fda and with the companies on when to cross over
the placebo group to the vaccine group,hin the placebo whether that crossover should happen in a staged way, it depending on the prioritization, that for instance the cdc would have put forward. that will happen, the question is when. is it a eua approval? is it went 10% of the population has been immunized for -- is it when 10% of the population has been immunized for a particular strategy? standpoint, there is a latest possible point. we are talking about a. bank-- the eua wasid that a pitspot on the trajectory to a
bla. it will have an impact on our capacity to continue to have control of the data. but it will not impact our capacity to continue to have data. we will just not have the control group anymore as they would be immunized. there are strategies to extract information from that. we also could potentially have impact on recruiting subjects and other clinical trials. i want to make a point here. we now know that vaccination is possible. we know that it is incredibly effective. it is very likely that both vaccines being tested to be as effective or substantially effective. i would ask that the population of people who want to volunteer and help to come and participate in these clinical trials.
without their participation, it is impossible to know whether more vaccines could be demonstrated to be effective and safe. and made available to the population. i think there is an individual benefit. be approved in the middle of december or so. by the time the vaccine starts to be laid out, you may be as an individual a late to the vaccine and one month or two months. if you participate in a clinical trial, you have a 50% chance of having access to the vaccine tomorrow. peopleuld be great for across the diversity of populations in the u.s. to please go and purchase bait and a clinical trial. any one of the clinical trials. sec. azar: thank you and thank you to the media for the excellent questions. two concluding points.
we will try to have these technical briefings occur on a regular basis for your benefit. second, for your readers, your whiskers, your viewers, i ask you to please keep emphasizing. with the vaccine news that we have and the therapeutical information that we have, there is light at the end of the tunnel. when he people to get there. practice good behaviors of washing your hands, watching her distance, wear your face covering sprague avoid the settings such as crowded indoor restaurants or home-based settings and doors where you are getting together with family, neighbors, and not watching your distance and wearing your face coverings. letting your guard down. you put yourself at risk. please do your -- please do that thing.
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