what is fda's position on this? >> you understand what we put in the letter of authorization and the conditions of use, we stand by those recommendations. the question you are asking should be referred to those who are distributing and making recommendations about prioritization but i would like dr. marks to answer the issue about one versus two doses so he can clarify what the fda's stance is on that. >> thanks. there has been a lot of noise about one versus two doses and the way the regiment was studied was that everyone ultimately, or almost everyone, received two doses of the vaccine, so we only know how people were protected with two doses and that that duration of protection that we have seen so far relates to having two doses of the vaccine. we spent so much time carefully reviewing the data and basing our decisions on science that it seems pretty foolhardy to conjecture that one does might be ok without knowing, so at least from the fda perspective, we would be recommending that people complete the two dose

the fda posted pfizer's summary, and its review documents, or the fda's review of the safety and efficacy. those are the things that will get discussed tomorrow in front of a group of a dozen or more outside experts, without conflicts of interest, representing those views and scientific expertise, including the consumer. host: what does an emergency use authorization mean? is a less rigorous process that vaccine would go through than the regular process? guest: an emergency use authorization is something that can only take place during or in preparedness for a public health emergency. that is a high-level public health emergency that could threaten our health security and national security. so, it's a special provision. it's not their normal approval that we see. requiring proof of safety and effectiveness, it requires basically a positive inefit assessment that -- which the benefits of the product outweigh the risks. fda's vaccinethe center has made clear that the vaccines given to healthy individuals, that even in an emergency, they have insisted on high standards of safety and effectiv

fda rather the fda weighs the advice it receives when taking actions on medical products.he fda ultimately makes the final decision on all matters that come before the committee. also setting expectations for today's meeting we organized the agenda topics to allow the committee members to have sufficient time for the questions before them. we invite the public and the committee to review the presentations and the recording of the december 10th meeting for more information on covid-19 epidemiology, vaccine safety, and operational distribution plans as those will not be covered in depth today as they were at the last meeting. as we begin meeting. as we begin today's proceedings i want to take the opportunity to thank you all, including the advisory committee members for the insight that they'll provide and also thank the fda staff, the sponsors and those presenting at the open public hearing today for participating. your contributions are very important in helping us at well-residenced science-based decisions. >> i'm the deputy director for clinical review in the division of

think -- the fda dr. pointed out that a covid 19 vaccine could provide a false sense of security could interfere with measures to reduce sars covid-19 transmission. i would argue that even with evidence that both vaccines are highly efficacious, there is still understandable concern about the danger of a false sense of security for those getting vaccinated no longer adhering to prevent preventive health measures such as wearing masks and appropriate social distancing. 2017 eua guidance included an fda approved vaccine requirement to accompany all use ensureproducts to " recipients are concerned -- informed about products they receive and inform them to any available products to be products and the risk and benefit of any available alternatives." since 2017, no eua for has provided written information about proven health measures such as wearing masks and appropriate social distancing, really being necessary and appropriate for covid-19 vaccine or civic -- vaccine recipients. less than 24 hours after the p

the fda now makes the next move and it could come at any time. the first shipment of millimeters of doses ready to all 50 states within 24 hours of the final sign-off from the fda. fedex will take the west, u.p.s. will take the east. tonight in the uk, how this is working already. from the moment they take the vaccine out of those freezers, how much time do they have to administer the shot? and what it says about what we'll see here. and tonight, your questions. is the vaccine safe? what about those two reports of allergic reactions? dr. jha is here to answer your questions and to put this in perspective for us. >>> all of this comes as the covid daily death toll hits an all-time high. more than 3,000 deaths in one day. and the dire new projections tonight. how many lives could be lost by january. hundreds of hospitals full. images from across the country tonight. and in california, patients now being treated in a converted parking garage. >>> amid the soaring covid numbers, president trump hosting another holiday party inside the white house. an

hahn of the fda? >> reporter: as this call was going on, the president was publicly lashing out on steven hahn on twitter for not getting this done faster and having his own staff and chief of staff lash out to him privately because we are told that mark meadows did call dr. hahn this morning and basically, complaining if they did not get this coronavirus authorized, this emergency authorization granted by the ends of the d ofe may not have a job. the job security of the fda commissioner now in question after the white house steve of staff told him to be prepared to resign if his agency doesn't grant emergency use authorization of pfizer's vaccine by the ends of the day. sources say mark meadows called dr. steven hahn this morning after president trump spent the week venting that the uk had already rolled out vaccines. top government health officials have said emergency authorization is in the works. >> the fda informed pfizer that they do, intend, to proceed towards an authorization for their vaccine

the fda press conference is beginning. we're going to go to the fda press conference and listen in. i'll get back to you afterwards. >> we applied our high standards of review in reviewing this product so americans can have trust and confidence that the vaccine meets fda rigorous standards for safety and effectiveness. with this authorization we know that our federal partners are already moving to distribute the first doses of the vaccine throughout the country. the fda's authorization is a significant milestone in battling the pandemic that has affected so many families in the u.s. and around the world. we are near the end what has been truly a year up like any other in modern times. while it has been marked by sadness, tragedy and sacrifice, it has generated unparallel scientific achievement. scientifics processes traditionally take years. what we have seen is an historic partnership among the private sector, academic researchers and federal government to find efficiencies in the scientific prot p pr processes and the dead came of time in the development of a rapid goal. efficienc

>> basically the fda says it can be distributed. the cdc recommends who gets it first and what should the dosing schedule be. what do you do if the patient doesn't come back at the scheduled time, what do you do if you don't have the vaccine on hand? but this is great step forward, but only one step on a very long road to getting people vaccinated. and there are going to bumps in that road. there's already been problems with the production. there will be concerns about adverse events just to be careful. fights about who gets it first. but what we have to understand is that it's not here yet. and right now we're in the midst of a surge upon a surge of covid. and we have to be as careful as possible as many of us as possible will still be around to get the vaccine when it's our turn. >> yeah, obviously that's so sensitive and important. sanjay, this advisory committee they've been meeting all day now and one of the things i assume they're going to provide is specific guidance for different groups, for example pregnant women and childr

science and data, guided the fda's decision. we worked quickly, based on the urgency of this pandemic, not because of any other external pressure. >> all right, you are listening to fda commissioner stephen hahn there give an update on the vaccine, which has been given emergency authorization and stephen hahn there, assuring people they have not cut any corners, that the fda did a very fast but incredibly thorough review of the vaccine. he, himself, said that he would absolutely take it. so we'll continue to monitor that, and bring you any more updates as we get them. >>> meantime, the state is still determining who will be next in line for the vaccine, behind health care workers and nursing home residents. abc 7 news reporter matt boone looks at what's being done to make sure powerful businesses or wealthy people can't just buy their spot in line. >> reporter: so phase 1 a is first and then fizz 1 b, likely essential workers and then a tiered system within that. the makeup of those tiers, though, is still being worked out. >> i

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the entire world will be watching what the fda is doing and are relying upon the fda. as the coronavirus vaccines continue to be using countries around the world, we must continue the process of innovation. developing countries need access to medicines not more than ever. [indiscernible] the vaccine for covid could be manufactured as a pill that would be easily distributed and prescribed in those countries with less access to health care professionals around the world. i am in agreement with other speakers before me on the issue of clinical trials and ensuring toal memos have access vaccines. [indiscernible] during these unprecedented times to do what was unthinkable in the past. we thank you for your hard work and your commitment. great, the neck speaker is lisa. lisachod afternoon, i am -- we send our gratitude to the vaccine and related biologic products committee for the opportunity to provide public comment on behalf of consumers. according to deployment of emergency use authorization for the pfizer-biontech covid-19 vaccine. we want to think that food and drug ad

but that means that the fda has more options.hen they offer that authorization, they could, for example, say we authorize it for people 18 and above. they could also take the committee's recommendation and say we authorize it for those 16 and above. they could ask more questions. for example, how long does that 95% effectiveness last? these are the kind of questions we're waiting to find out as we wait for that eminent possible fda approval and authorization. >> you raised good questions that we'll dig into over the course of the hour. gather, how is pfizer gearing up for the next step morgan was talking about? what's it going to look like to actually get the vaccines rolled out from manufacturing facilities like the one you're standing in front of to the arms of ordinary americans? >> reporter: that's right, ayman. this is an outstanding logistical challenge here. as morgan mentioned, this is one of the manufacturing facilities, one of two really here in the midwest. this is the largest one in the entire country. we expect that

meaning fda guidance. this means that there are over 19,000 participants for whom safety data is available for at least two months. it's the total safety population if there were over 8,000 subject ises shown at the top of whom seven days of local and stmic reactions were obtained by electronic day log. on the left-hand side of the top, vaccination doses were given 21 days apart. this will step at the safety measure as well as to evaluate cafe sit. individuals can either be swabbed if the investigative site. we used an electric diary to the vaccine administration. encompassing 6,000 subjects and 500 in each of the countries that are inb colluded in the trial. we also captured adverse events. we collect serious events for at least six months and related after the end of the trial of two years after the second dees dose. so now let me share with you electric data related to local adverse event. this represents data that were captured over seven days after dose one and dose two in 16 to 55 and 56 to 85-year-o

gerber for -- and everyone else at the fda. because the amount of work that you have done is just extraordinary. and the briefing packets that have been circulated are clear and extremely helpful. so thank you very much for your ongoing work. the question i have for you is it will be advantageous for a number of reasons to have one of the covid-19 vaccines available under a biologic license application instead of an eua. and i realize it's a difficult question but can you offer any comments about the route or the pathway forward for the fda to begin to think about when you've reached the point that you would consider a bla? >> yes. so first of all we do want any vaccine that is made available under an eua to continue its testing, to allow for its licensure as soon as possible after issuance of the eua. so this continued evaluation, as i explained in my presentation, i think first and foremost, would include some longer term follow up of participants enrolled in ongoing studies, as well as safety and effectiveness data coming ou

because of the white house pressure on the fda and how the fda has sometimes caved to that during this pandemic, the fact that there is an outside panel that advises the fda on this crucial question about this vaccine is -- is good. that's good news. and it's the kind of people who you want making this decision. it's like the editor in chief of the new england journal of medicine, the most influential medical journal in the world. he himself is an esteemed infectious disease doctor associated with harvard medical school. also there's the researcher from the university of pennsylvania who actually invented the row tow virus vaccine. row tow virus vaccine is currently in use around the world. it is on the global list of essential medicines. it saves literally hundreds of thousands of lives versus per year. the guy who invented that vaccine is on this panel advising the fda on the safety and efficacy of the coronavirus vaccine. also the university of iowa researcher who is not just a world-renowned virologist. they've got several of those on this panel. he's actually a world-renowned coro

the fda approved on a second dose. for me this is a moral sponsor ability to make sure that second dose is available for the american people. it.ave just held onto it is in our cadence for delivery, 21 days later for pfizer and 28 days later for moderna. that is the plan right now. i think both the reserve and the second dose decisions, we will have more information over the next few weeks, middle january, middle february, i see a transition. thank you. >> we have time for two more questions. thank you for taking my question. --know real estate ugly realistically, vaccines when they get shipped, there might be some spoilage. what kind of estimates are you taking into account or how much loss of vaccine there might be as this goes out, and how that affects your predictions or how many americans will be able to get vaccinated right away? you we havesure taken extreme precaution in execution and delivery of the vaccine. early on in my decision-making on how to deliver a vaccine, this was a bone ability identified in the w

thank you. >> so, first, i should say that the fda defines what the fda would like to see in to the file. and it is not the operation that does that or the company. but having said that, i do think that there is a large set of data coming out of the uk and brazil trial in terms of efficacy and safety. that data is still being digested because of the contrasted outcome that happened in regard of the immunization regiment that was used. and it is not obvious or straightforward to come to a conclusion why there appears to have been substantially different efficacy outcomes, 90% to 62%. and frankly unless there is a very clear explanation based on facts and data of what is behind those two numbers, it is very likely that that vaccine will not be sufficient for approval or be the first one to say, here. but of course the fda will make their own decision. next to that clinical set of data, and safety data, which is quite important and significant in the numbers is, of course, also the manufacturing data. the fda would want to understand the manufacturing process and the facilities in which the

and while we await fda approval of pfizer's covid vaccine after the fda committee recommended the approval, we will talk to one of the doctors who voted yes, dr. paul offit, just a minute away. and as congress struggles to get a relief deal done, is the standstill putting the record rally at risk? "power lunch" begins right now >>> thank you, ty. welcome to "power lunch. we're watching shares of disney up 15% today it's inning vestor laid out plans for domination on the streaming front. it's also a big week for ipos, with airbnb up and doordash still up more than 65% from its ipo price of 102 and we're waiting pfizer and biontech let's get to meg tirrell for more on that story hi, meg. >> hi, kelly while we are expecting the fda to issue emergency use authorization, really at any point now after this positive vote from its advisory committee last night, here's the timeline of what we're looking for in the coming days. so the fda is working now essentially on that emergency use authorization. today and over the weekend an outside group of advisers to the cdc is meeting to discuss the vaccin

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>> the fda would do that. >> thank you.or the clarification. >> let's just go by recognized -- individuals i recognize. >> thank you. i disagree. i think the question that's being asked is do we have enough evidence in hand to say that the benefits of this vaccine outweigh at the moment what is as far as severe safety issues are theoretical risks. i think the answer to that question is clearly question. the question is never, when do you know everything. it's when do you know enough? we have trials of 44,000, 30,000, that's as big as any general pediatric vaccine trial. the difference is follow-up. we don't know whether or not it's going to be effective six months from now. but there are systems in place to know that. we don't know whether or not it's going to have a rare serious side effect. but there are systems in place to know that. given what we know so far about the height of the human response, about what we have with response, we can feel pretty comfortable that this vaccine is going to have a benefit that lasts for

they call a meeting with the fda commissioner this morning.t you had that job? >> well, it is understandable, dana. one of the things that happens a lot when you're fda commissioner is getting pressure from all sides, some wanting to go faster when they're really important unmet needs like a pandemic that's currently out of control in the united states and many parts of the world. on the other hand, concerns about making sure that treatments that we are using are ones that people can have confidence in and the fda has worked with support from the administration on a remarkably fast process to get us to this point. we're almost there. the fda does need to take a close look at the data and review it in public. that's what's going to help make sure people decide to take the vaccine when it is approved. >> so let's talk about that. there is still a lot we don't know. when you have a story or piece in "the wall street journal" i'll read part of it to viewers. best way to answer these questions is through randomized clinical trials. that's why the v

their vote doesn't bind the fda, but the agency usually does follow their lead. the goal, to have 60% to 70% of the country vaccinated to achieve herd immunity and protect our communities from this virus, which is why this meeting will be repeated again next week as the fda considers the equally promising vaccine candidate from moderna and again to consider other vaccines like that from johnson & johnson and oxford/astrazeneca. all of it to get to this point. for all americans and eventually all the citizens of the world. >> i can't stop smiling and as you saw her the first woman to get it, smiling under her mask. sanjay, thank you for that. so assuming this gets approved by the fda perhaps later today, how quickly are we going to see the impacts of vaccination across this country? >> well, you know, the vaccine itself is likely to be rolled out if it's authorized today within the next few days and i think we could see for the first time people outside of the clinical trial getting this vaccine in the united states, so that is a pretty remarkable timeline. when d

i think the fda was going to authorize this today or tomorrow any way.be they have managed through political pressure to move things up by 12 hours. i think it's unnecessary. i don't think it's helpful. ed fda is acting on science. >> reporter: it makes no sense because they were going to approve it, if not today, then tomorrow and this becomes a political issue by this story. i imagine it must be incredibly frustrating for you as a physician to watch the trump white house interfere at this critical moment right now, potentially giving americans another reason to doubt the safety of this vaccine? >> absolutely. i think what most americans need to do is just ignore the bluster coming out of the white house, follow the science, follow the scientists at the fda. you know, what we saw yesterday in that hearing of the advisory committee was a great discussion about the science and the science on the pfizer vaccine is pretty clear, it's safe, it's effective, and when people are eligible, when i'm eligible, i will take it so that is what we need to focus on rig

so, we recommended it to fda. fda will make that final determination. my understanding that, that will be in a matter of days. could be tomorrow. i don't know their exact timing, but we're talking days, not weeks. and then, after that, i believe vaccines could start shipping. there is also a step from the cdc that needs to occur and as you know, wolf, each state has started to define priority populations, such as healthcare workers, elderly individuals in long-term care facilities, et cetera, as priority populations to receive this vaccine. >> it's really important. it goes, now, to the full fda. then, it goes to the cdc. our chief medical correspondent, dr. sanjay gupta, doctors, is with us as well. i know he's got some questions for you as well. sanjay, go ahead. >> well, first of all, congratulations on being part of such an historic day and historic vote. i mean, the world is paying attention right now, obviously. i'm curious and i'm ask you, dr. offett, i was following along specific subgroups, such as pregnant women or women of child-bearing age,

it expects to file for fda approval in january. the oxford astrazeneca vaccine currently in phase three trials among people who received an initial low dose followed by standard dose. the vaccine was 90% effective. some experts believe this vaccine may take longer to be approved in the united states. >>> and the hope these vaccines are providing is real. the u.s. confirming nearly 223,000 new cases just yesterday. another new record for you. and another 3,100 new deaths. now, that's also a record and the first time that we've ever surpassed that 3,000 mark. statewide, those numbers also setting a new record with nearly 31,000 new infections. california now nearing 1.5 million. nearly 200 more people have died. >>> taking a live look at los angeles this morning. this is just really one of the hardest hit areas not just in california, but the nation. cases continue to sky rocket. just a month it's seeing an average of 43 deaths per day. barbara, the county's public health director broke down in tears yesterday talking about the devas

but on the fda side dr. stephen hahn spoke about how they worked on getting this vaccine authorized quickly. he emphasized, as we heard, that there were no corners cut, and then he mentioned how there are, you know, the moving parts now of looking at distribution and looking at getting vaccine doses out to states. so that's what we heard. but there was also mention, victor, of how clinical trials are continuing. there was no mention of how fda scientists are still looking at data. and there was mention of how there are still some questions we need to answer, questions specifically about pregnant women, for instance, what does the vaccine mean for them, for children underage 16, for people with a history of allergic reactions to vaccine. all of those groups are areas of interest for the fda right now. so that was mentioned as well and the commissioner said that as data, you know, continues to be collected, we should hear more updates on what has been found. >> and we heard dr. hahn there emphasizing that it w

gerber and everyone else at the fda. because the amount of work that you have done is just extraordinary. and the briefing packets that have been circulated are clear and extremely helpful. so thank you very much for your ongoing work. the question i have for you is it will be advantageous for a number of reasons to have one of the covid-19 vaccines available under a biologic license application instead of an eua. and i realize it's a difficult question but can you offer any comments about the route or the pathway forward for the fda to begin to think about when you've reached the point that you would consider a bla? >> yes. so first of all we do want any vaccine that is made available under an eua to continue its testing, to allow for its licensure as soon as possible after issuance of the eua. so this continued evaluation, as i explained in my presentation, i think first and foremost, would include some longer term follow up of participants enrolled in ongoing studies, as well as safety and effectiveness data coming ou

>> morgan radford at the fda, thanks very much. >>> dr. question of what you expect the fda to do. we expect them to grant the emergency use, but we already have seen the uk has said if you -- has put out a warning to folks if you regularly have allergic reactions to things, don't take this vaccine. do you expect more warnings like that up front from our fda when we assume happens in a couple hours when they approve this vaccine? >> i think so, chuck. it hasn't been discussed. so far this morning, you know, that hasn't been discussed. it was brought up in the public session around lunchtime and it's going to come up later on. generally, most vaccines, one of the questions we ask, have you had allergic reactions to vaccines and medications? they're looking for these propensities. the striking thing to me, and i want to underscore what commissioner hahn said and morgan said, making it so transparent. the process so transparent. it's so important. i've been watching the fda hearing all day, and it feels historic for that reason because not on

all eyes are on the fda advisory panel. they're meeting and voting as we speak. >> that's right, wolf. they just concluded the vote. the fda's independent advisory committee, they are recommending that the fda provide emergency use authorization for moderna's coronavirus vaccine. that was the full committee vote, 20 committee members voted yes. one person abstained. no one voted against this emergency use authorization. the next step is it goes back to the fda to make a decision about whether to grant that emergency use authorization. that could move relatively quickly. we doesn't know how quickly. the fda has looked a lot of this moderna vaccine and put out various recommendations before the independent met and discussed this vaccine and voted on it. we wait to hear the final word from the fda. we'll see another cdc meeting this weekend. after we get word from the fda, it won't be long that we see this vaccine going out to states as well. we know that the supply of vaccines has been extremely limited that's been getting ou

if you talk to people at the fda who explain this. that, of course, has not been sufficient for president trump who long held a belief that scientists at the fda are, would go slowly to thwart him politically. a claim made before the election and one he's made since then that the fda denied. clearly, the fda thought this was going to be a tense meeting. putting out a statement last night to axios from commissioner hahn saying that it's not, he's not the one who makes this decision. the career scientists looking at data, going through it. they make the decision about whether or not one of these vaxzens can be used on an emergency basis. what would happen before that pool approval would be granted. so, of course, the white house doesn't seem to have a lot of options here, because it's not like they can be unhappy with the fda commissioner and fire him with six weeks left to go in the administration. many people do not think that would be a wise decision. though it is one they could take. also, if they get the advisory panel to move up t

this fda had that crazy, sunday-night eua for convalescent plasma, where the fda commissioner botched-- the stats. so, they didn't need this. this was going to come, this weekend. this wasn't going to speed up delivery. that's already set. it was potentially, very destructive. >> i want you to take a listen to this. this is what the president posted on his twitter page, right after the fda news was announced. here it is. >> we have given pfizer and other companies a great deal of money, hoping this would be the outcome and it was. on behalf of the american people, i'd like to thank all of the brilliant scientists, technicians, doctors, and workers, who made this all possible. when the china virus invaded our shores, i promised that we would produce a vaccine, in record time, before the end of the year. they said it couldn't be done. but with today's announcement, we have now achieved that goal. the united states is the first nation in the world to produce a verifiably-safe and effective vaccine. >> okay, so, look, he wants credit. but you can't really separate out the handling of the

was that through conversations with the fda? is there any pressure on the fda to make a decision by that date given that's what you're planning on? thanks. know, i'mrna: so, you an army general and army generals plan. got up on my white board, right, and i said, oh, e.u.a. on this day. and then i got word that said the verpak sessions were going to be on this day. they filed, verpak was specified and i said, okay, somewhere in this window, right, after they work through the details, is probably the earliest potential opportunity for an eua. my white board clearly speculates only if the eua approve would distribution begin. but we needed to do an estimated date so we could backwards plan the requirements for distribution. for example, if we think it is coming out on that day, and we wanted to distribute available vaccines immediately following several administrative things have to occur. one, the states need to tell us where they would like the vaccine delivered to, at what quantities. two, the companies have to prepare the packa

they advise the fda essentially. then the fda itself would approve.ling out if we be fair early next week. dr. natasha kathuria thank you for coming on. we'll see if there is a vote this evening. >>> taking the streets. morgan stanley giving back to the street food vendors of new york city pledging two million dollars to keep the folks in business. the funding will give over 2,000 vendors $1000 for rent, utilities and food. so popular when so many businesses are going through tough times now. to support a strong immune system, your body needs routine. centrum helps your immune defenses every day, with vitamin c, d and zinc. season, after season. ace your immune support, with centrum. one of the worst things about a cois how it can make you feel. but, when used at the first sign, abreva can get you back to being you in just 2 and a half days. be kinder to yourself and tougher on your cold sores. to all the businesses make it through 2020... thank you for going the extra mile... and for the extra pump of caramel. thank you for the good food... and the g

the fda is expected to make a decision soon. if approved, vaccines will be shipped out to the states. you can see all of today's advisory committee meeting tonight at 8:00 eastern on c-span. and next week, another fda public meeting, this time reviewing the moderna coronavirus vaccine, and whether an emergency use authorization should be issued for that. that's scheduled for 9:00 a.m. next thursday. we'll have it live on c-span3, on line or listen live with the free c-span radio app. >> we can nights this month, it's american history tv programs to preview what's available every weekend on c-span3. tonight, as health officials prepare to roll out a vooaccine against the coronavirus, american history tv presents "reel america" with five films about vaccines and the fight against disease. watch beginning at 8:00 p.m. eastern and enjoy american history tv every weekend on c-spa c-span3. >>> 20 years ago, one of the most highly contested presidential races in u.s. history took place. the 2000 presidential contest between texas gover

the fda could

the fda on the safety and efficacy of vaccines, they last night voted that the fda should approve the first coronavirus vaccine in the united states. we have been waiting today to see whether the fda would respond to that by, in fact, approving the vaccine. just in the past few minutes, that has just happened. "the new york times" breaking the news that the fda has just approved the pfizer coronavirus vaccine tonight. we will have more details coming up on that in just a moment with somebody who is very much in a position to understand exactly what that means. plus we'll be talking about the fact that the trump white house really does appear to have fundamentally screwed up even that good news tonight at the very last minute with a very ill-timed, very ill-advised threat against the fda. we've got all up., and i think it's probably going to keep getting bigger as the hour goes on. stay with us. life doesn't stop for a cold. [man] honey... [woman] honey that's why there's new dayquil severe honey. it's maximum strength cold and flu medicine with soothing honey-licious taste. dayquil ho

this is how the fda evaluates the vaccine candidates. to the white house we go in washington. >> what that means by doing things parallel in a parallel manner, corners were not cut here. this is a vaccine that has gone through -- these vaccines are going through the large kinds of trials that we would expect from prophylactic vaccines that will be given to a large number of people. the average vaccine development program for the kind of prophylactic that we're talking about is 21,750 people enrolled. so this -- these programs went from 30,000 to 45,000, 44,000 individuals enrolled. that is a pretty nice size program. so that is giving us kind of the gold standard types of clinical trial program that we like to see for preventative vaccines. >> thank you, dr. marks. one question that is circling and dr. slaoui just talked about it is whether americans should take this vaccine. so let me ask that question to you. why should americans trust these vaccines? >> so the reason why i'm sitting here today and the reason why we're going through th

why is the fda here taking longer?are using the same trial data, the same results from the company. what is the holdup? dan: there's a couple of reasons. the main reason is political, such as the quick we just saw. governor cuomo, kamala harris and other democrats have suggested the fda was acting under little pressure, donald trump and the white house, largely the has been untrue but in return, the fda is overcompensating and making sure no one can accuse them of acting under political pressure so it's slow to the approval of these vaccines. in addition, the fda has always been approved. it's a historic legacy going back into the 1960s, the fda always has to be pushed. operation warp speed on the dirt the direction of the former client executive did exactly that. we are likely lucky to be getting this quickly. criticism of governor cuomo means on the fda, the more time it will take to approve these new vaccines. paul: kim, what you make of anthony doughty criticizing this decision in the approval process thing u.s. is

the fda now makes the next move and it could come at any time.hipment of millions of doses ready to all 50 states within 24 hours of the final sign-off from the fda. fedex will take the west, u.p.s. will take the east. and tonight, in the uk, how this is working already, from the mome t

the fda began their review of the fires are. >>bio and tech data to see if vaccine actually meets the threshold for emergency use authorization after hours of presentation. the agency voted 17 to 4 as you mentioned just seen to approve the vaccine, 17 said yes for said no one abstained seeing the benefits of the vaccine outweigh any risks associated with it. now the study involved more than 43,000 participants aged 16 years and older. it included healthy participants and those with chronic diseases, including hiv hepatitis b and c infections in addition to people who are obese and have other co-morbidities the participants were given 2 doses of the vaccine space to 21 days apart. the women in the study were screened for pregnancy before each dose was given and if they were in fact pregnant. they were either excluded from treatment or it was discontinued and participants. they were monitored 30 minutes one month and 6 months after last dose now researchers or looking for any serious adverse reactions or side effects of the vaccin

fda chief dr. stephen hahn was summoned to the white house to meet with chief of staff mark meadows and sources tell cnn that the president is demanding to know why pfizer hasn't been given the green light for the vaccine. we'll have more on that in a second. >>> first, let's get to the latest troubling sign of how the surge of the virus right now is only getting worse, not better. hospitals being pushed to the brink as the number of americans requiring hospital care because of covid continues to shatter records, now on a daily basis. cnn's stephanie elam is live in los angeles. she's tracking the latest from there. the numbers where you are worse every day. how are hospitals coping? >> reporter: we're looking at these numbers rising here, kate, as we're looking at the hospitalizations coming close to record numbers in california. if you look at the country overall, 34 states and puerto rico all had at least one record day for hospitalizations in november according to johns hopkins university and t