the circumstances justifying the eua no longer exists. the agenda for today's meeting will include the following conclusion of my talk. provide an update on covid-19 epidemiology. following lunch ab open public hearing and then we'll guide into a discussion of the data. first with the presentation by pfizer and then fda presentation. at the end of the someday, we'll have a committee discussion and a vote. if the vaccine were made available. we would like the committee to discussion the plan, including how placebo controlled follow up in ongoing trials should be addressed. following discussion of these items, we'll have a single question for the committee to vote on. this concludes my presentation. thank you very much. >> thank you. thank you for a clear presentation. we have a fair amount of time before the next scheduled presentation which is very good. i think there's some questions and clarification that the committee may have about our guidelines for discussion and for our eventual vote. i may be having technical difficulties. >> i go

i'd like to say before we move to the next slide that eua, i want to start with last week's eua sharingthe deliberation must take time to transparently include all expert members questions amendments and explanations. today is not about pr. it's about you public health seriously. the next slide titled eua is not a standard approval, trials must continue. do you want to control covid-19? then you have to keep the control groups going. anything less risks accountably for industry and fda, we need public trust from vaccines that come from public knowledge of how they work long term. what does that mean, placebo groups must continue along trials. it's trand missismissions that in diseases and death. next, we have to include the compensation program. and then we need to get media elected officials, fda and moderna and the peer industries to know that euas not seen as approvaling with transparency on that. and eua should not be precedents. and next slide. we need transparency on diversity. so, this means for age and co-morbidities, because the population is so vulnerable, how many are 75 year

if you limited the eua to a specific set of populations, even those populations that have the eua, placebo-controlled trials would be possible? >> we'll have a discussion on those considerations later this morning. in fda's view, issuance of an eua for a covid-19 vaccine should not preclude the conduct of the placebo controlled trial. in particular situations where that vaccine made available is available only in limited quantities. wax -- >> okay. i can see now. thank you for fixing it. dr. lee? havee of the questions i is a little bit more general. i recognize we are considering the pfizer product. future applications, if for example there's a vaccine bla, vacciner a number one, let's call it that number. will it make it more challenging for future products to reflect the eua? >> i think what you are getting the fourth criterion for issuance of an eua which says there must not be any adequate, approved, and available alternative therapy. >> correct. availablene is made under an eua it's not approved. that would not preclude issuance for another vaccine. if a vaccine is approved, it would not necess

again, we are planning to be ready when eua is approved.t is not about getting in front of eua, it's just making sure that we have everything locked so when eua decision comes, distribution to the american people becomes immediate within 24 hours. that's our goal, that's what we're striving for, and that's what we're working to. you can't execute if you don't have a plan, and that's what our emphasis is as we work through all that process. we are going to send half the doses based on allocations to the jurisdictions and agencies because it is a two-dose regimen, as dr. slaoui just talked about, so half the allocation will be sent out, and then 21 days later for pfizer and 28 days later for moderna, we send out the second half of allocations. two reasons, one, to ensure that we don't overadminister and that we have the second dose on hand, and second reason is to make sure that we don't overwhelm limited storage capability and capacity at the state level. we want to augment their plans, enable their plans, not constrain them from the greates

an eua must be granted and must be granted tonight. as of yesterday, the daily death toll for covid-19 exceeds the death toll on september 11th, 2001. delays object september 10th will be more death on january 10th. in the words of todd beamer, let's roll. thank you. >> thank you. the next speaker is answer are moussen. >> thank you for allowing me a few moments to speak. i'm a virologist and affiliate at the georgetown center for global health science security. i'm also -- i have an advisory relationship with siemens. how the vaccines are working after they are rolled out to the public. so this expedited process has moved considerably faster than the typical vaccine development time line. as such, we are inherently limited on the breadth and scope of data that's available on durability and effectiveness of the immunity as well as the variability of different vaccinees responses. due to excluding criteria in the trial itself, there's limited data available on minority and underserved populations as well as pediatric populations, pregna

an eua, we need this vaccine. we need to do our very best to develop herd immunity.need this vaccine. and -- but we need to move it from an eua to a bla as soon as it satisfies the threshold that the fda will hold this vaccine to. but there are many reasons to move it to a bla such as it will be included in the vaccine injury compensation program if the cdc recommends it for adults and for children. so i think we need to move in that direction. thank you. >> i'm not talking -- i agree with you -- >> very quickly. >> quickly. i just think that -- i'm talking about perception more than reality. with those two statements out there, the people who have severe allergic reaction shouldn't get this vaccine, we need to offer people some solace that this is not going to be a problem for them. i'm not saying this should stop us. i'm saying, when this rolls out, this is going to be an issue. i'm not saying it's biologically sound, i'm saying we need data to argue against it. we just need data to address it. that's all i'm saying. >> i agree. >> thank you. i think we agree perce

supply of the initial eua for mass vaccination. is that a criteria that would potentially impact the decision on future eua's for other vaccines? >> thanks for the opportunity to clarify that question. actually, the supply of pfizer vaccine is secondary at this time, for considering issuance of an eua for a different vaccine. and that's because the pfizer vaccine is not approved. so consideration of available alternatives requires that the alternatives both be approved and adequate. so the fact that the pfizer vaccine is not approved, it means there is currently no approved available and adequate preventive vaccine for covid-19. >> thank you. >> dr. rubin. thanks, dr. think, for that for that verynk, clear presentation. i'm curious what fda will do with the discussion item on dr. goodman's proposal. is it likely to end up an fda requirement or strong recommendation to perceive to bla? for the manufacturers? >> as i explained before, we're working actively with the vaccine manufacturers on accruing data that would be necessary to su

in the context of the proposed eua. the known benefits of the vaccine at this time include a reduced risk of confirmed covid-19, at least seven days after completing the two dose vaccine regiment. priorduals without history of infection. efficacy findings are consistent across subgroups including racial and ethnic minorities. adults 65 years of age and older. and individuals with one or more of the following conditions. obesity, hypertension. chronic hyper total pulmonary disease. data and adolescence 16 and 17 years and 17 years in age are limited but can be extracted from adults 18-55. a slide for here is risk. the known risks include local and systemic reactions. generally mild-to-moderate and dosefrequent following two. in adults over 55 years of age, they were less frequent compared to the younger adults. adverse events included the shoulder injury we attributed to vaccine administration or to the vaccine itself. there are no specific safety concerns identified in an analysis of the subgroups described. fromata are

products advisory committee, the one that met today and voted to recommend to the fda to grant the eua, that's really important, chris, because what it shows is that the process we have here in the united states is decisions and recommendations are made by independent bodies just the way the data and safety monitoring board looked at the data a while ago and said it looks good, let's examine the data and see if we can get an eua. the advisory committee to the fda now has made that recommendation. the reason i think this is so important is that we want to make sure that we impress the american public that decisions that involve their health and safety are made outside of the realm of politics, outside of the realm of self-aggrandizement and are made in essence by independent groups. so it was a very important step

and under the eua, in order for us to issue an eua, we have to make a determination that the benefitsuct outweigh its rescue. >> do we just add -- marion, what if we just add the words "eua" to this voting question. would that be possible? >> based on the totality of scientific evidence available due to the benefits of the moderna covid outweigh its risk for -- >> for use under an eua in individuals -- >> for use under an eua in individuals 18 years of age and older. we can do that. >> do you have to take that to your lawyers? can you make a determination? >> we can do that. we can say for use under the eua in individuals 18 years of age and older, if the committee needs that clarification, then i think we can safely do so. >> dr. monto, may i make a comment? >> yes, please. >> the question is very clear, do we think that this vaccine's benefits outweigh the risks. if we think that, then the fda will make a decision as to whether or not an eua. that's not what we're voting on. we're voting on whether the benefits of this vaccine out weigh the risks and it's up to the fda to make a dec

so november 30, moderna submitted data to support the eua. and as you can see in the orange bars, the medium follow-up for safety and efficacy in subjects at the time of the interim analysis was seven weeks after dose two. to align with the expectation for a minimum of two months of follow up, as outlined in the guidance, moderna later submitted on december 7 additional data from the schedule final analysis as an amendment to the eua. the median follow up for safety and efficacy at the time of the final analysis was around nine weeks after dose two. so, the majority of the slides that i will present today will show data from the interim analysis, unless it's otherwise specified as final analysis data. however, i just want to note that we have independently verified the vast majority of the analysis from the final analysis, and this includes the primary end point, the associated subgroup with the primary end point, the key secondary end points, and the solicited and unsolicited data. and we have not identified any notable differences in terms

and then we would do our initial push based on eua and what is available. and then we would put them in the cadence, as dr. slaoui in normal routine distribution, accordingly, so states and jurisdictions would then have three vaccines, to distribute to their plan. r. slaoui: final question, please. >> last question is from andrew dunn with business insider. your line is open. andrew. sir.ead, r. slaoui: we can't hear anything. somebody is on mute. next rator, go to the question. >> sure. no problem. from hasam n is ahmed with a.s.p., your line is open. reporter: thank you for taking my question and doing this interaction. can you hear me? >> yes. reporter: yeah. so i had a question for dr. slaoui. if you've been following it all, the russian data from -- with regarding to the sputnik vaccine, which i know they haven't accrued that much, but it looks relatively promising, i wonder if you have any thoughts regarding that and whether that could ever be a possibility for the u.s. and the second part of the question, do you expect all three million nursing home

again, we are planning to be ready when eua is approved. it is not about getting in front of eua. it's just making sure that we have everything locked so when eua decision comes, distribution to the american people becomes immediate within 24 hours. that's our goal. that's what we're striving for. and that's what we're working to. you can't execute if you don't have a plan. and that's what our emphasis is as we work through all that process. we are going to send half the doses based on allocations to the jurisdictions and agencies because it is a two-dose regimen, as dr. slaoui just talked about. so half the allocation will be sent out, then for pfizer, then for moderna, we send out the second half of allocations. two reasons. one, to ensure we don't overadminister, and that we have the second dose on hand. and second reason is to make sure that we don't overwhelm limited storage capability and capacity at the state level. we want to augment their plans, enable their plans, not constrain them from the greatest distribution capability that they have. we utilize a tiberius platform

as we mentioned, this is standard practice for an eua. it is voluntary. it is going to be voluntary for our forces, and those who do not get vaccinated, they will be adhering to all of the existing public health mitigation measures that have been in place for months and that have allowed the department to carry on its mission. >> and at some point, if the fda does determine to license, fully licensed, the vaccination, at that point, the voluntary may change to mandatory as determined by the department, so that is a possibility in the future. all right. let's go to courtney. >> hey. i am still unclear on when exactly you think you're going to get -- i know it is hard to say when it is going to come through, but when exactly you think you will start getting these 44,000, and will they all be distributed equally among the locations? is how many? sorry, my kid is here. >> that is ok. i understand. i will let general place speak to that last issue, but in terms of the question in terms of the initial 44,000, when it will happen, so i do not -- i cannot give yo

we are going to have an eua, right? decision, but to be prepared for it. this week, this past friday, all of the jurisdictions, all 64 jurisdictions and five federal agencies locked in their micro plans for the pfizer vaccine. based on the vaccine we provided to them we locked in 636 locations by quantity vaccine delivery if and when the vaccine is approved. as i've talked about, we will begin upon approval of the eua, packing to the micro plans, and begin distribution within 24 hour hours out to the jurisdictions accordingly. our goal is to make sure we can ensure the vaccine is delivered in a timely manner. and that it's delivered safely, securely, and it's ready to be utilized to start administering vaccine as soon as possible. to that end, what we also already did, i gave permission to already distribute syringes and needles, alcohol wipes, and dilutant which is required in support of the pfizer vaccine. we will begin that today and distribution will be completed by friday. again, only to set conditions and if it si

we had to plan for the best outcome without knowing exactly when eua would occur. we immediately went into action and implemented a sliding scale that allowed us to ensure that everything is in place and people are ready accordingly. the first shipments should arrive monday morning, and extensive coordination will ensure that this occurs. we have worked with pfizer, ups, fedex, federal and local law enforcement agencies to ensure safety and security of the vaccine. make no mistake, distribution has begun. now ochs's are being packed and -- boxes are being packed and loaded with vaccine and within the next 24 hours they will move vaccine from the pfizer facility to the ups and fedex hubs. then it will go out to the 636 locations nationwide which were identified by the states and the territories. we expect 145 sites across the states to receive vaccine on monday. another 425 sites on tuesday and the final 66 wednesday, completing the initial delivery of the pfizer orders for vaccine. at the sites, the vaccine will marry up with the ancillary kits we have distributed,

as soon as the eua is officially administered. >> emergency use authorization. >> yeah, right. the emergency use authorization. essentially immediately after that. it likely will be a day or at most a couple of days. but it is essentially right from the time that you get the official authorization by the emergency use authorization, what we refer to as an eua. >> you recently apologized for criticism of the uk's speedy authorization of the pfizer vaccine. can you just talk about your initial concerns about that and the speed at which this is happening? >> well, you know, we here in the united states, the food and drug administration, no doubt really is the gold standard of really careful scrutiny of all of the data, all the minutia of the data of the clinical trials. that's just the way our fda works. some may say it's a bit too careful, a bit too slow, but it really isn't. it really makes very much the front burner safety and absolute certainty of efficacy. other regulatory agencies in europe and the uk may do it a little bit differently, not necessarily better or worse but ju

somebody said to me the other day, i heard there's eua coming about. are you going to start planning? i said start planning? we literally started planning as dr. slaoui talked about seven months ago. it was in parallel that we executed this. we assumed success so that we could get ahead of the problem. because of the great efforts by the cdc, the collaboration of commercial industry and the states herculean effort to plan for people to receive shots that we're going to be successful. so with that said, i will tell you, i am 100% confident that we will be able to implement this. with our collaboration of the trifecta there, we will be successful, and we will start to have shots in arms within 96 hours of eua. that's what i believe with all of my heart. and i am counting on it because i for one have told my mother, get the vaccine. i told my sons, get the vaccine. that's how confident i am in this. so i ask for you as dr. slaoui said at the end, right? all of us, the american people, we can beat this only together. right? we can do this if we do it toget

an eua is a lower bar of scrutiny and evidence than fda aproval. the department of health and human services must first declare an emergency in the case of the covid-19 vaccine, phase three trials will continue after an eua is issued. next question, an independent panel voted to recommend an eua for pfizer's vaccine. was the vote unanimous? a panel made up of the leading scientists held a meeting on thursday. 17 said yes to the recommendation. here are four who said no. one of those noes, dr. fuller from the university of michigan had this to say. i've learned in research studies over and over again and want us to apply wisdom. the longer way around is the shorter route to effectively reach the goal. instead of an eua, she was in favor of expanding access in a continuing phase three study. this is probably the most common question, who decides if i'm at risk and eligible to be first in line to get the vaccine. the first shipment will be limited. california is expecting enough to vaccinate 1 million people this month. that's why the governor release

time you get the official authorization by the emergency use authorization, what we refer to as an eua. >> you recently apologized for the uk's speedy authorization of the pfizer vaccine. can you talk about your concerns about that and the speed at which this is happening? >> we here in the united states, the food and drug administration, no doubt is really the gold standard of really careful skrcrutiny of al the data, that is just the way the fda works. some may say it's a bit too careful, a bit too slow. but it really isn't. and it makes safety and absolute serenity of efficacy. others in the europe and uk may do it differently. not certainly better or worse but differently. we do it in a way that may seem to be very careful and very, very slow. but it really isn't. the career scientists at the fda, they know what they're doing. they do this for a living. they do it all the time. they're doing it as quickly as they possibly can. but for sure, it's going to be done very carefully and with a great deal of scrutiny for the data. >> dr. fauci, last hour, there was a great piece about vac

>> and we have consented to you prior to vaccination and provided you with the education, emergency eua of pfizer biontech vaccine? >> yes. >> do you have any questions before i proceed? >> no. >> okay. and which arm will we be doing today? >> the right. >> the right. okay. >> are you sure? >> i'm fine. yes. >> which one are you delivering on? >> ambidextrous. >> all right. i'm going to ask you to jud hold your scrub top up. wipe here. it's a little cold. all right. nice deal breath, in through your nose, out through your mouth. a little poke. one, two, three. all right. all done. >> you're an excellent inoculator. >> thank you. >> there you go. [ applause ] >> thank you. >> congratulations and thank you doctor. pleased now to welcome our fourth recipient. charlize stewart. a nurse on labor and delivery and at the nurse at the bedside of a nursing mother. showing delivery patients are front and center. >> confirm this is your name and birth date and we provided you with consent and information about the covid vaccine. >> yes. >> any questions before me proceeding? >> no. >> which arm wi

by pfizer and following the eua by moderna.e are really doing well in my opinion in distribution. over 14 million doses of vaccine have been distributed to date. i will talk about that going forward. not only are we pushing first dosage vaccines, but we started pushing second dosage vaccines for the pfizer vaccine, as people who received the first dose around january will start to be eligible for the second and we want to ensure that the vaccine was available to all. the cadence for our execution is really coming into good posture. we are allocating to the states on tuesday. states are available to order off the allocations on thursday. we are picking and packing supplies to ensure it can be delivered by the following week. a really remarkable effort by the collective group of professionals, the men and women who have been working tirelessly from pfizer, moderna, mckesson, and fedex as they execute this everyday. and they are the ones that are executing the movement of the vaccine. i would be remiss if i did not highlight the g

instead of an eua she was going to control access through a phase three study. who decides if i'm at risk and eligible to be first in line. california's expecting enough to vaccinate about a million people this month. broken down by priorities and tiers. top of the lirks health care workers, most at risk and residents of nursing homes and similar settings. he warns the logistics of distribution will be complicated. >> there's room for speed bumps and politics and contentiousness. >> two more questions. when will last quarter get the vaccine. when will kids get it? there are three tiers of priority. all in health care. police not included. neither are other essential workers. as for kids, the vaccine is for 16 years and older only. full fda approval. here's what we know. in a ten-month period fires reported their vaccine as 95% effective and that the saichlt over a two-month period. they're investigating two cases of reaction to the fightser shot. that concern was raised by the advisory panel. those are your top vaccine questions. we have more on our website. chr

clearly, the nex vaccine that we're lking forrd to eua this week is the moderna vaccine. and in that light we know that we're going to ship just a little butt short of 6 million -- a little bit short of 6 million doses out to the american people. and we're shipping it to 3,285 locations across the country. it'll be a very similar cence that was executed this week with pfizer where we're hitting initial sites on monday, follow-on tuesday and wednesday, and then by the end of the week we're just in a routine cadce of execution. i cannot tell you enough, right, what role commercial indusy's playin in this. pfizer, eventually moderna, right, a the work that they're doing to get the vaccine prepared for final destructs, mckesson and the distribution of all the ancillary kits for the pfizer vaccine which included syringe needles, alcohol wipes andty lieu about the. d then they will also be responsible for cutting the vaccine -- kitting the vaccine for merna. so really a remkable work. and then fedex and ups, i just can't say enough to the men and women o fedex from the leadersh

for an eua to be issued, the career scientists conduct evaluations of currently available scientific evidence about a medical product. the fda must determine the product benefits outweigh its risks. for vaccines that have the potential to be given to millions of all the americans, we have set high expectations. for yesterday's action on pfizer's covid-19 vaccine, our career scientists conducted a fast but incredibly thorough review of a complex request involving manufacturing data, quality control data, safety data, effectiveness data, and more. our career staff has been working around the clock including holidays and weekends and late nights to swiftly do this evaluation that meets are our recognized high standards for review. i know the meticulousness of the review and i will take this covid-19 pending availability and distribution because i have complete trust and confidence in the career staff evaluation. to ensure all americans can have have in the review, we made this review process as transparent as possible. we held a public advisory committee on thursday about the pfizer bio

the initial push after eua, relatively easy. we had very good plans that had been worked through through the states all the way through ows, cdc, down to our industry partners. the key was transitioning into a regular cadence of available vaccine doses so that we could just keep moving. want to pause and then collect vaccines and then distribute a week or two weeks later. we just want a continuous flow of vaccines out to the american people every day, extending availability to more. in order to do that, we have to forecast, and then, we have to eventually figure out what is available. again, i take responsibility. i am learning that as we go. it looked very good on paper. paper plans are very good. execution is where we learn. and we adapted accordingly. >> operator, next question. >> the next question comes from john from bloomberg. your line is open. >> hi. thanks so much for taking my question. can you tell us a little bit more about the sort of difference between when vaccines are manufactured and when they are released? and

now pfizer's vaccine may get emergency use authorization known as eua as early as tomorrow. next. >> i am 100% confident that we will be able to implement this. that with our collaboration of the trifecta there we will be successful and we will start to have shots in arms within 96 hours of eua. that's what i believe in all my heart. >> the pain of covid also being felt across the economy. the national restaurant association says one in six restaurants nationwide have already closed for good this year. we can expect that number to grow as winter arrives and dining outside becomes less appealing in colder states. that means a lot of jobs are about to disappear right around the holidays. >> so president-elect biden is laying out an extremely ambitious plan to combat the pandemic in the first 100 days in office. he won't immediately end the pandemic but we can do something about it. >> we'll start where we can require masks under the law, like federal buildings, trains, planes, buses. this team will get at the last 100 million covid-19 vaccine -- at least 100 million covid vacc

the initial push after eua, relatively easy. we had relatively good plans that had been worked through through the states all the way through oh ws, cdc -- through ows, cdc, down through our industry partners. the key was transitioning into a regular cadence of available vaccine doses so that we could just keep moving. we do not want to pause and then collect vaccines and then distribute a week or two weeks later. a continuous flow of vaccines out to the american people every day, extending availability to more. in order to do that, we have to forecast and then we have to eventually figure out what is available. again, i take responsibility. i am learning that as we go. it looked very good on paper. paper plans are very good. execution is where we learn. and we adapted accordingly. >> operator, next question. >> the next question comes from john from bloomberg. your line is open. >> hi. thank you for taking my question. can you tell us a little bit more about the sort of difference between when vaccines are manufactured and when

pirg and with giving education about the eua of the fisa vaccine? >> you have. >> you have any questions or concerns from? >> none whatsoever. >> which arm will we be doing today for your vaccine? great. that's easy. take off your jacket. [inaudible] >> i did. i'm working out. >> thank you. ante for all you doing to keep us safe. -- thank you for all you are doing to keep us safe. >> okay. i'm just going to wipe the site. roll your sleep up a little bit. -- sleeve. this is a vaccine of .3 amount. hold that up. thank you. all right, barbara, nice deep breath. one, two, three, there we go. >> did that hurt, barbara? >> not at all. >> thanks a lot. [applause] >> all right, congratulations on being the first part in this historic moment and being vaccinated. i'll write very well. i am now thrilled to welcome our second recipient, our second recipient is doctor raymond, an anesthesiologist. he works as an anesthesiologist brings him in close contact with covid-19 patient in the emergency department as well iss on labor and delivery. he helped to manage t

long day of deliberation and a key panel this evening recommended that the fda grant the so-called eua, the emergency use authorization. the fda now has to decide whether to take that recommendation. but even if it does then the cdc will have to give the final sign-off on sunday. anticipation is high. covid cases and deaths are higher. the vaccine is not the end. it is not a cure. in fact, if you're sick you probably shouldn't take it. but you're going to be able to ask a doctor that in just a moment. we are at the potential beginning of the end. let's discuss what is and what may be with the man, dr. anthony fauci. welcome back, sir. >> good to be with you, chris. >> two state of play questions. first, why so much alphabet soup? why fda the cdc and cdc back to fda but then you've got to wait for -- why so much alphabet soup? why couldn't this have been streamlined? >> no, it's really important, chris. the fact that the fda's advisory committee, the vaccine and related biological products advisory committee, or vrpac, the one that met today and voted to recommend the fda to grant the e

used during this pandemic, including for this vaccine action, is the emergency use authorization or eua, created by congress specifically to provide us with the means to respond rapidly during a public health emergency. for an eua to be issued the fda's career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product, the fda must determine that the product's known and potential benefits outweigh its known and potential risks. for vaccines that have the potential to be given to millions of healthy americans, we at the fda have set high expectations. for yesterday's action on pfizer, biontech's covid-19 vaccine the fda's career scientists conducted a fast but incredibly thorough review of a complex eua request involving manufacturing data, quality control data, safety data, effectiveness data and more. our career staff of scientists and staff have been working around the clock including holidays, weekends and late nights to swiftly do this evaluation that meets our globally recognized high standards for review. i know the meticulousness o

. >> we have given you educaon about the eua of pfizeraccine. >> you have. any questions or conrns for me? >> non- whatsoever. >> which arm will be redoing today f your vaccine? eat. please take off your jacket. >>wo to work yesterday, barba? >> i did. >> thank you for doing all that youo to keep us safe. >> okay. all right. i'm just gng to wipe the site. roll your sleeve up a lite bit. this is a vacne of .3 ml. [background noises] [background noises] >> barbara, nice deep breath, one, t, three, little poke all done. did it hurt, barbara? >> not at all. >> well done. [applause] >> cgratulations. >> congratulations barbara on ing the first part in this historic moment ineing vaccinated. ve well, i'm not throat to welcome our second recipient, second recipient is doctor raymond flaw and anesthesiologist. his work brings them in close contact with covid-19 patients in t emergency department as well as on labor and delivery. heelps to manage the airway o covid patients which represents the highest healthcare risk to providers. doctor. i'm an anesthesiologist,oo.

eua, obviously, emergency use authorization. we're waiting on that. give me a sense, though, of how crucial it is. i mean, is there a chance they may say no? i mean, we do know that canada and the united kingdom have already started with the syringes putting them in people's arms. >> that's right. liz: so that's already happening. i understand how our regulations work and really it is there to help us, but people are very anxious. what do you think should be a fair amount of time before we start to see what's in those boxes start getting into people's veins? >> yeah, i don't think any longer than a couple days would be reasonable. i think there's an outside chance that the fda doesn't aapprove it because of the allergic reactions that occurred in the u.k. over the past week. but i don't think that's reason enough, and i think the testimony that was provided today through pfizer and others who were testifying, i think they made the point that that wasn't reason enough not to provide the emergency use authorization. so i think it'll happen within the ne